Title of Invention	A process for preparing a synergistic herbal pharmaceutical composition.
Abstract	An improved herbaceous botanical product and method of manufacture are provided which is easy and inexpensive to produce and effective. The preferred herbaceous botanical product comprises Echinacea purpurea and product parts. The product can manufactured by blending or mixing the designated parts thereof. The products has many uses, including but not limited to the treatment of herpes and other diseases.

Title of Invention

A process for preparing a synergistic herbal pharmaceutical composition.

Abstract

An improved herbaceous botanical product and method of manufacture are provided which is easy and inexpensive to produce and effective. The preferred herbaceous botanical product comprises Echinacea purpurea and product parts. The product can manufactured by blending or mixing the designated parts thereof. The products has many uses, including but not limited to the treatment of herpes and other diseases.

Full Text	This invention relates to a process of preparing a synergistic herbal pharmaceutical composition. Background of the Invention The present invention relates to herbaceous botanical products and methods of manufacturing the same. Herpes simplex virus (HSV) commonly referred to as herpes virus or herpes, is an infectious disease which has reached crisis proportions nationally with estimated numbers of infected people at 70%-80% of our population as reported by the American Societal Health Association (ASHA) and growing annually by 500,000 people. There are two common types of herpes: herpes simplex virus 1(HSV 1) and herpes simplex virus 2(HSV 2). Herpes enters the human body through minuscule breaks in the epidermal tissue usually by contact with an infected host and is marked by eruption of one or more vesicles, usually in groups, following an incubation period of approximately four days. Typically the course of the infectious outbreak initiates with the prodromal stage; advancing to vesicular eruption; followed by ulceration, coalescing; resolution; and the latency period. The outbreak can last for several weeks and on average lasts two-three weeks. In some immune compromised individuals the outbreak can last for months. The vesicles can appear anywhere on the skin or mucosa, typically appearing on the lips as cold sores, glands, oral mucosa, conjunctiva and cornea, genitalia, anal mucos and peri-anal tissue. Herpes symptoms includes: inguinal swelling, pain, fever, malaise, headaches, muscle aches, and swollen glands. Some individuals who have the trigeminal nerve compromised with oral herpes, have excruciating facial pain, difficulty swallowing, eating and facial swelling. Individuals with the sacral nerve affected have severe upper leg pain, swelling and great difficulty walking. Herpes simplex virus (HSV) infection is recrudescent, residing in the nerve ganglia, then recurring due to some, as yet unknown, stimulus. Recurrent herpetic infections can be precipitated by almost anything, including: overexposure to 'sunlight; nutritional deficiencies; stress, menstruation; immunosuppression; certain foods; drugs; febrile illness; etc. Recently herpes virus was isolated from cardiac tissue. HSV 1 and HSV 2 infections pose very serious health threats often causing: blindness; increased cancer risk of the cervix; aseptic meningitis and encephalitis; neonatal deaths; viremia; etc. The devastating effects of this disease, go well beyond the medical scope of human suffering. HSV is responsible for serious psychological and emotional distress as well as substantial economic loss to the nation and the world. Various treatments for herpes have been proposed and have included topical application of such agents as povodone-iodine, idoxuridine, trifluorothymidine, or acyclovir. Such treatments have met with varying degrees of success. Most prior treatments have proven disappointing. Acyclovir, taken orally for systemic treatment of HSV, is somewhat effective. However, acyclovir is only successful in interrupting the replication of the virus. It is not successful in treating an infectious outbreak either systemically or topically. Strains resistant to acyclovir have been reported. Individuals with Auto Immune Deficiency Syndrome (AIDS) are seriously immune-compromised and suffer especially debilitating outbreaks of HSV. Additionally, AIDS individuals may carry acyclovir resistant strains of HSV, which can make acyclovir ineffective for these individuals. It is, therefore, desirable to provide improved herbaceous botanical products and methods of manufacturing the same which overcomes most if, not all of the preceding problems, and provides for other uses. SUMMARY OF THE INVENTION An improved herbaceous botanical product is provided comprising a plant and a surfactant. /Advantageously, the plant .herbaceous botanicall/of the genus Echinacea and -h-- surfactant comprises benzalkonium halide. The herbaceous botanical product can comprise by weight: from about 2% to about 90% of a herbaceous botanical of the genus Echinacea; and fr6m about 0.005% to about 0.8% benzalkonium 'caffeoylquinic acid)and chloric acid (2, 3-0-di-caffeoyltartaric acid) and derivatives thereof; from about 0.2% to about 4% echinolone; from about 0.2% to about 8% echinacin B; from about 0.1 to about 6% echinaceine; from about 2% to about 7% anthonocyanins comprising cynanidin 3-0-B-D-glucopyranoside and 3-0-(6-0-malonyl)-B-D-glucopyranoside; from about 0.01% to about 0.06% pyrrolizidine alkaloids comprising tussilagine and isotussilagine; from about 0.003% to about 0.009% isomeric dodeca isobutyalamides and tetroenoic acid; and from about 0.01% to about 2% caryophylenes. Desirably, the herbaceous botanical products described above can be used as a medicament. Advantageously, the herbaceous botanical products described above can be used in the preparation of a product for the treatment of a disease, such as: herpes simplex virus 1, herpes simplex virus 2, varicella zoster virus (herpes zoster), cytomegalovirus, human immunodeficiency virus (HIV), or epstein barr; viral influenza (flu), shingles, geniculate zoster, herpes keratitis, chicken pox, cytomegalovirus, papilloma • virus, viral ,, parainfluenza, , adenovirus, viral encephalitis, viral menijgitus, arbovirus, arenavirus, picornavirus, coronavirus, syntialvirus, viral infections, common colds caused by virusesngivostomatitis, roseola infantum. organ transplant rejection, pneumonia, infectious mononucleosis, uveitis, retinitis, human papilloma virus, cervical carcinoma, vaginal carcinoma, vulvovaginitis, human herpes IV, and Kaposi's sarcoma. The herbaceous botanical products described above can be manufactured or produced by blending or mixing the above-designated parts of the herbaceous botanical products. The herbaceous botanical products can be used in conjunction with an improved medical treatment and medicine which, when applied in the topical manner, rapidly relieves pain and heals lesions of herpes virus. Advantageously, the improved medical. treatment and medicine are safe, inexpensive and effective. The 'improved medicine, also referred to as Viracea, comprises a novel medical composition, formulation, antimicrobial compound and .•solution. The new antimicrobial medical treatment and microbicidal medicine are successful in treating primarily herpes simplex virus (HSV 1 & HSV 2) topically and can be useful in treating other herpes related microbial infections including, but not limited to: varicella zoster virus (herpes zoster) and cytomegalovirus. In some circumstances, it may be useful to use the novel medicine systemically. Advantageously, the improved medical treatment and medicine of the present invention yielded unexpected, surprisingly good results. Initial, topical, in vivo testing, demonstrated relief from pain in minutes and speedy total resolution of vesicular eruption in all individuals tested. When the inventive medical treatment and medicine are applied at the prodromal stage, the infection is interrupted and no further outbreak occurs. In vitro testing of the novel medical treatment and medicine demonstrated extremely surprising inhibitory effects on herpes virus. Desirably, the novel medicine is made from readily available, over the counter (OTC) chemicals or products and provides a safe comfortable, economical and user - friendly treatment. While the novel medicine and antimicrobial compound is particularly useful in dramatically inhibiting herpes virus simplex, it may be useful in treating other microbial diseases (microbe-causing diseases)such as: human immunodeficiency virus infection (HIV), Epstein barr, papilloma virus, cellulitis, staphylococci, streptococci, mycobacteria, influenza, parainfluenza, adenoviruses, encephalitis, meningitis, arbovirus, arenavirus, anaerobic bacilli, picornavirus, coronavirus and synsytialvirus, as well as varicella zoster virus and cytomegalovirus. This easy to use microbicide solution provides a moderately 'water "resistant coating]upon application to either the prodromal tissue" or the erythematous vesicular herpes lesion. Upon contact, there is a slight tingling effect. Within minutes of application, the pain of the infection resolves. Gradually, inguinal swelling subsides, fever, malaise, body aches, and nerve involvement subsides. Typically, within, twenty-one hours all external symptoms and physical manifestations of infection are resolved -ind the vesicle is dried and resolved. A particularly surprising, beneficial effect provided by this inventive medicine, is that when it is applied at the first sign of outbreak, the prodromal stage, all symptoms and signs of further infectious outbreak stops! No eruptions appear or any further escalation of symptoms of the infection. The outbreak literally stops! Desirably, the novel medicine (medical composition) includes microbe inhibitors which inhibit, suppress and stop microbial infections from microbe-causing diseases. The microbe inhibitors comprise antimicrobial isolates, botanical extracts or phytochemicals, of at least a portion of one or more of the special plants listed below. The microbe inhibitors can comprise viral inhibitors to inhibit viral diseases, such as: herpes simplex virus 1 (HSV 1), herpes simples virus 2 (HSV 2), varicella zoster virus (herpes zoster), cytomegalovirus, HIV, epstein barr, papilloma virus, viral influenza, viral XV parainfluenza, adenovirus, viral encephalitis, viral menigitus, arbovirus, arenavirus, picornavirus, coronavirus, and synstialvirus. The microbe inhibitors can also comprise bacterial inhibitors to inhibit bacterial diseases, such as: cellulitis, staphylocci, streptoci, mycolbacteria, bacterial encephalitis, bacterial meningitis, and anaerobic bacilli. In some circumstances, the microbe inhibitors can include fungi inhibitors. Better results are obtained if Echinacea or other plants are not used in the medicine in their raw, untreated and uncut state. For even better results, the medicine can exclude: Arabinose, betaine, cellulose, copper, fructose, fatty acids, galactose, glucose, iron, potassium, protein, resin, sucrose, sulfur, vitamin a, vitamin The improved) medical treatment provides a novel method and process for use in treating the above infectious diseases by applying the microbial inhibitors on the microbial infected area and maintaining the microbe inhibitors on the infected area (region or surface) until the external symptoms and physical 'manifestations of the infection disappear, reside or resolve about the infected area. The medicine can be applied by ./-.praying, dabbing, dusting, swabbing, sponging, brushing, pouring, dispensing, covering, or heavily coating the medicine on the microbial infected areas, such as: oral mucosa, nasal mucosa, vagina tissue, labial tissue, anal tissue, peri-anal tissue, lips, cutaneous tissue, ocular tissue, conjunctiva, and eyelids. While the medical treatment and medicine is particularly useful for inhibiting herpes and other infectious diseases in persons (human beings) (homo sapiens), they can also be useful for veterinary purposes for treating viral and bacterial infections and infectious diseases in animals, such as: dogs, cats, birds, horses, cows, sheep, swine (pigs and hogs), and other farm animals, as well as rodents and other animals seen in zoos. Preferably, the improved medicine, medical composition or microbial compound is a phytochemical concentrate which is combined and simultaneously or concurrently applied with a surfactant and a carrier, solvent or diluent to provide a microbicide medicinal solution. To this end, the interesting microbicide solution comprises an antimicrobial detergent^surfactant, with botanical extracts. The surfactants preferably are cationic surfactants which can1 comprise singly or any number of quaternary ammonium chlorides having 6-18 carbons such as alkylbenzyldimethylammonium chloride, mixtures of alkylbenzyldimethylammonium chloride, alkyldimethyl/ethylbenzylammonium chloride, n- alkyldimethylbenzylammonium chloride, diisobutylphenoxyethoxyethyldimethylbenzylammonium chloride, N- (Ci2Ci4Ci6) dimethylbenzylammonium chloride, benzalkonium chloride, octyldecyldimethyloammonium chloride, didecyldimethylammonium chloride, dioctyldimethylammonium chloride, dialkyldimethylammonium chloride, dialkylmethylbenzylammonium chloride, octyldecyldimethylammonium chloride, dimethylbenzylammonium chloride, laurryldimethylbenzylammonium chloride, o-benzyl-p-chlorophenol, dideryldimethylammonium chloride, doctyldimethylammonium chloride, alkyl dimethylbenzylammonium chloride, and preferably comprises j:lkylbenzyldimethylammonium chloride most preferably benzalkonium chloride. The range of activity of the cationic surfactant can be 5% to 90% but for best results 8% to 20%. Quaternary ammonium salts are readily available commercially. In some circumstances it may be useful to use other surfactants, such as, but not limited to: fCMSO,\|gTycolic acid surfactants, enzyme surfactants, ampholytic surfactants, switterionic surfactants, and nonionic surfactants. The surfactants can comprise detergents, wetting agents, emulsifiers, defearners, and/or surface tension reducing additives. Carriers are useful for mixing the constituents, keeping the constituents in solution, and providing an easy method of application to the affected area whether by spray, dropper, or applicator. While an aqueous solution, preferably a sterile aqueous carrier and solvent is preferred for best results, in some circumstances it may be desirable to use other liquid or solid carriers, such as: glycerin, mineral oil, silica, cottonseed oil, coconut oil, vegetable oil, seed oil, fish oil, or animal oil, alcohol, talc, corn meal, beeswax, carnauba wax, beta carotene, garlic oil, camphor oil, soluble vitamins, soluble minerals, rape seed oil, nut oils, olive oil, liposomes, ascorbic acid, evening primrose oil, pycnogenol, grape seed oil, lanolin, Ethocyn, collagen, aloe vera, bee pollen, royal jelly, chondroitin sulfate A, sea vegetables, EDTA, fatty acids, herbs, lecithin, bioflavinoids, grain oils or powders, algae, J:eas, vinegars, acidophilus, cell salts, ascorbic acids, hydra 5, \ glandulars, amino acids, psyllium, plant derivatives, or other sterile carriers. The botanical extracts antimicrobial isolates or phytochemicals contained in this new medicine and medical treatment can be comprised of: Arabinose, betaine, copper, echinacen, echinacin B, echinacoside, echinolone, enzyrr.es, fructose, fatty acids, galactose, glucose, glucuronic acid, inulin, inuloid, iron, pentadecadiene, polyacelylene compounds, polysaccharides such as but not limited to arabinogalactan, potassium, protein, resin, rhamnose, sucrose, sulfur, tannins, vitamins a, c, and e, xylose. For better results, the .phytochemical concentrates include the above phytochemicals, excluding Arabinose, bataine cellulose, copper, fructose, fatty acids, galactose, glicose, iron, potassium, protein, resin, sucrose, sulfer, xylose and vitamins a, c and e. The botanical extracts, antimicrobial, isolates and phytochemicals are separated, extracted and isolated from portions of plants, such as: pimpinella anisum, myroxylon, arctostaphylos, carum, capsicum, eugenia mytacea, coriandrum, inula, allium, gentiana, juniperus, calendula, origanum, mentha labiate, commiphora, plantago, rosmarinus, ruta, baptisa, artemisa, sage, mentha, parthenium integrifolium, eucalyptus, asteriacea, and preferably from the genus Echinacea of the family Astericaea, namely, Echinacea purpurea, Echinacea angustofolium, (Echinacea pallidae), Echinace vegetalis, Echinacea atribactilus and their Echinacea pallidum and cultivars. . For best results, I ^ the phytochemicals and antimicrobial isola\|tjeb are extracts from Echinacea purpurea and Echinacea angustifolium. The inventive technology, treatment and medicine yield very attractive, unexpected, surprisingly good and consistent results. Tests show the microbicide solution (medicine) and medical treatment to be extremely useful to: control herpes outbreaks, viral shedding, extend the latency periods of the disease, ar.u dramatically inhibit the virus, while being generally safe to the atient and the environment. The herbaceous botanical products have many other uses, which include, but are not limited to, the treatment of various diseases.nerpes microbicide and treatment completely inhibits herpes virus, as well as other infectious microbial diseases, and are ..safe and non-toxic to humans, animals, and the environment. The herpes microbicide and medicine can comprise a surfactant and an herbaceous botanical providing a botanical extract, phytochemical, antimicrobial isolate, viral isolate, microbe inhibitor, and viral inhibitor. The preferred microbicide composition can comprise: a surfactant; an aqueous diluent; and the herbaceous botanical of the genus Echinacea (E) , of the family Asteracea, species: purpurea, angustif olia, pallidae, vegetalis, atribactilus and the cultivars. Preferably, the herbanaceous botanicals are extracts and isolates comprising Echinecea phytochemicals as found in and extracted from Echinacea purpurea, E. pallidae, and E. angustofolia. For best results, the medical treatment and microbicide (medicine) comprises: a cationic surfactant; the phytochemicals from E. purpurea, and E. angustofolia; and a sterile aqueous diluent. The surfactant provides a certain debridement of epithelial cells with a broad spectrum of antimicrobial action. Surfactants of this nature can comprise quaternary ammonium salts containing 6-18 carbon atoms. Preferably the quaternary ammonium salt surfactant, is a mixture of alkyl dimethylbenzylammonium chlorides, which can be: benzalkonium halide, benzalkonium bromide, benzalthonium chloride and most preferably benzalkonium chloride. The herpes treatment comprises a 100% active aqueous solution but can also be used in concentrate. The solution can comprise by weight various concentrations of surfactants such as 0.005% to 0.8%, preferably 0.02% to 0.30% and most preferably 0.02% to 0.26%. The phytochemicals in the botanical Echinacea have demonstrated impressive activity against bacteria, viruses, and some fungi. The exact mechanism is unknown. When tested topically in vivo on HSV 1 & 2, it is effective in treating herpes simplex infectious outbreaks. When tested in vitro, it showed inhibitory activity against HSV 1 & 2. The phytochemical concentrate composition comprises the following isolated constituents, botanical extracts, microbial of water to the combined concentrates of benzalkonium chloride and phytochemicals can comprise a range of 2:1 to 100:1 with a preferable range of 4:1 to 40:1, and for best results can comprise a ratio of 6:1 to 20:1. For best results, the improved microbicidal treatment and medicine (microbicide) for herpes, comprises by weight: 0.02% to 0.3% benzalkonium chloride and to avoid toxicity preferably less than 0.26%; 40% to 60% Echinacea phytochemicals; and 20% to 60%, most preferably 29.74% to 59.8% sterile water. While water is the preferred diluent and carrier, it may be desirable in some circumstances to use other carriers in order to propel the concentrate through a sprayer, or for greater solubility and efficacy. It may also be desirable in some circumstances to include a viscosity control agent. Furthermore, while it is estimated that the shelf life of the improved herpes medicine is two years, it may be necessary to add an appropriate preservative. For preferred use, during any outbreak or physical manifestations of herpes and preferably at the first sign of the prodrome stage of tingling, itching, or irritation of herpes, the medical solution (medicine) should be applied topically on the infected area. The affected (infected) area should be dry as dry as possible depending on location of outbreak- The method of topical application of medicine can be by: spraying, dabbing, dropper, or any such method as to coat the entire affected area. The coating of the solution (medicine) should be maintained until all external symptoms completely resolve, reapplying as needed anytime the coating diminishes, for instance, after showering. Anionic soaps and anionic detergents, and especially protein content soaps can be contraindicated. Preferably, the infected area should be washed, cleaned and dried prior to application of the medicine. CLINICAL PHARMACOLOGY A preferred surfactant is benzalkonium chloride. Benzalkoniu~ chloride in aqueous solution is commercially available under tr.e brand name and trade mark Zephiran? distributed by Sanofi Winthrcp Pharmaceuticals (formerly Winthrop Labs). Benzalkonium chloride is a' rapidly acting anti-infective surfactant with a moderately long duration of action. The surfactant is active against bacteria and sorfte viruses, fungi and protozoa. Bacterial spores are considered to be resistant. Solutions of benzalkonium chloride are bacteriostatic or bacteriocidal according to concentration. The exact mechanism of bacterial action of benzalkonium chloride is unknown but is thought to be due to enzyme inactivation. Activity of benzalkoniu/chloride generally increases with increasing temperature and pH. Gram-positive bacteria are more susceptible to benzalkonium chloride than gram-negative bacteria. Unfortunately, benzalkonium chloride is inactivated by soaps, anionic detergents, serum, and certain proteins. Benzalkonium chloride has fallen out of favor in many laboratories for the above .reasons. When benzalkonium chloride was used alone and tested topically in vivo, it was ineffective for herpes simplex infectious outbreaks. When tested in vitro on HSV1 & 2 benzalkonium chloride demonstrated undesirable high levels of toxicity to the cells even at high dilutions, which is medically unacceptable. While raw, untreated, unclean, non-isolated Echinacea is generally ineffective to treat herpes, it has been found that some, but not all, of the isolated constituents and botanical extracts of Echinacea (as previously described above) provide phytochemicals, antimicrobial isolates, botanical extracts and microbe inhibiters which are effective in treating herpes virus and other infectious diseases. When the gchinacea phytochemicala (antimicrobial isolates, botanical extracts and microbe inhibitors) were mixed, combined and-applied with a surfactant, preferably benzalkonium chloride, and a sterile aqueous carrier, the results were unexpected and surprisingly good in resolving (treating) herpes virus and other infectious diseases and the effectiveness of the medicine ;microbicide) dramatically increased. When the synergistic medicine was tested topically in vivo, the herpes simplex infections were immediately-arrested. When the synergistic medicine was tested in vitro, the benzalkonium chloride surfactant was substantially less toxic and within a safe level and there was a higher level of inhibitory activity against HSV 1 & 2. The synergism interaction and mixing of the Echinacea phytochemicals and surfactant were demonstrated and observed by viewing the rapid solubility of the components when mixed arli the slight adhesive quality created by the properties in solution. Furthermore, the chemical properties of the Echinacea phytochemicals, surfactant and aqueous carrier enhanced stabilization and increased reactivity which is useful in treating infectious diseases. The medicine can be used in varying dilutions on: oral and nasal mucosa; vaginal tissue; labial tissue; anal and peri-anal tissue; penile tissue; cutaneous tissue; open subcutaneous tissue; and in higher dilutions on ocular infections. By varying the concentrations, the medicine may possibly be administered parenterally. The medicine may be contraindicated in vaginal or anal packs; in the ear canal; occlusive dressings; casts or ingestion and such use may produce irritation or chemical burns. It may not be advisable to use the medicine to treat anaerobic fungal infections, since some fungi may be resistant. EXAMPLES 1 - 7 In an initial, topical application, in-vivo study that was undertaken to evaluate the effects of the medical treatment and medicine of the present invention'upon seven human test subjects who had been tested positive for HSV 1 or 2. The subjects were treated topically with the medicine comprising benzalkonium chloride surfactant in an aqueous solution (at a ratio of 1:750) in combination with the herbaceous botanical Echinacea purpurea in powdered form containing the previously listed phytochemicals. Application of the composition was made by a two-step procedure by first wetting the affected area or vesicle with the benzalkonium chloride surfactant in an aqueous solution by spraying, dabbing, or using a dropper; then applying a coating of the powdered phytochemicals over the wetted area by either swab or manually sprinkling the powder onto the infected area. An important aspect in this treatment was maintaining complete coverage of the affected area for the duration of the outbreak. Therefore, the area of outbreak was kept covered with the medical composition by reapplying as needed. Of the seven subjects, six were female, and one was male. At the beginning of this study, the age of the male was 38, the female subjects were ages 8, 27, 30, 32, 38, and 39. There were twelve infectious outbreaks over approximately six weeks. Nine of the outbreaks were HSV 2, genital herpes, and three were HSV1, cold sores. The 8 year old and the 27 year old females exhibited the HSV 1 (cold sores). The 30 year old, 38 year old and the 39 year old females exhibited the HSV 2 (genital herpes). The 38 year old also had a HSV I cold sore. The male exhibited HSV 2 (genital herpes). All subjects tested had a well established history of the disease and could identify the standard course of their disease. To obtain objective data, none of the test subjects knew anything about the test treatment or any action.-"of the medicine. On repeat tests, the subjects were told that there may be placebos mixed in the samples of formula. In seven cases, the antimicrobial compound (medicine) was applied directly on tissue at the prodrome stage. In five cases, the antimicrobial compound was applied directly on erupted vesicles. The antimicrobial compound was reapplied as necessary to maintain coverage. Observations: With each application of the medicine, each individual (test subject) reported a tingling sensation for a few seconds. They also reported that there was a substantial degree of adherence of the medicine (antimicrobial) compound to the vesicle(s) or affected area. The adherence of the composition to the epithelial tissue remained to a degree even after showering or water rinsing the area. Results: The results of the testing of the 7 subjects with the medical treatment and medicine were unexpectedly surprisingly good and very consistent. In each case, the subject happily reported that once the composition (medicine) was applied to the affected area, the pain completely stopped within 10 to 20 minutes when nothing in the past had ever eased pain before. In the seven cases, where the compound (medicine) was applied at the prodrome stage, the subjects reported that the pain stopped, all symptoms that would have previously escalated to full outbreak ceased and the outbreak never again occurred. All external symptoms and physical manifestations of herpes disappeared within a few hours after the medicine was applied. In the five cases, where the compound (medicine) was applied to erupted vesicles, the subjects reported that the pain stopped in minutes and the burning, itching and irritation resolved in two to four hours and the vesicles dried up and were gone in twenty-one hours. In all cases, the other more extreme, debilitating symptoms of: fever, malaise, inguinal swelling, weeping sores and painful urination stopped, once the medicine was applied. In follow-up, where subjects had been given a supply of the composition (medicine) to test on future outbreaks, it was reported that if the initial signs of an outbreak exhibited, signaling the prodrome stage of an outbreak, the compound (medicinej_ was immediately applied by the subjects as per instructions and the outbreak was fully arrested and resolved. Significantly, it was also reported by subjects who were accustomed to experiencing several outbreaks annually, that they had remarkably longer latency periods. In a three year follow-up with one individual who had reported severe outbreaks monthly for four years prior to use of this medicine, she now reports that she has not had an outbreak in over a year since using this medicine. Additional Observations: One human male subject reported that after the initial application during the prodrome phase of an outbreak, he showered and forgot to reapply the composition (medicine) for a period of approximately 30 hours. Consequently, several vesicles erupted and began to coalesce. The subject proceeded to reapply the composition (medicine) and thereafter kept the area well coated with the composition. Subsequently, the outbreak resolved in 21 hours in the same manner as described with the other human subjects. Another observation indicated that the composition (medicinej may be weakened or less effective in the presence of certain proteins or soaps. One human female subject, may have been overly zealous in cleansing the affected area prior to application of the composition (medicine). This occurred during "a third outbreak after having success with the composition (medicine.) on the two prior outbreaks. In this instance, when the -comppsition (medicine) was applied, there was no familiar tingling sensation and no relief from symptoms. Approximately 24 hours elapsed before she sought any advice and the outbreak had escalated to the full vesicular eruption stage with all the foregoing symptoms of the disease. She was instructed to thoroughly rinse any soap residue from the area, dry the area and reapply the composition (medicine) . After following the instructions, she reported that the outbreak has been fully resolved, as it had in the two prior outbreaks, by applying the medical composition. EXAMPLES 8-13 Dermatological and Veterinary Testing Animal testing to determine any possible dermatological allergic reaction induced by the medical composition (medicine) was undertaken. Six animal subjects were used. The animals included 3 female rabbits (ages unknown); 2 dogs (1 female 2 year old, and 1 male 9 year old); one,' 3 year old neutered male cat. In these animal tests, the above composition (medicine) was applied, in the previously stated method, to the inside of the outer ear of each animal. In all instances, the area being treated was kept coated with the compound for twenty-four hours, matching the time human subjects had used. The testing performed on the six animal subjects indicated that there were no signs of dermatological irritation or allergic reaction. EXAMPLE 14 The above medical compound containing viral inhibitors was also tested on a papilloma virus 'caused wart on the muzzle of a two year old gelded thoroughbred horse. Papilloma virus warts are difficult to treat. The wart measured 25mm in diameter. The antimicrobial compound (medicine) was applied twice daily. The wart was then measured at each application. Results: Quite unexpectedly, the wart decreased dramatically in size by approximately 3mm per day while the medicine was applied to the wart and on the fifth day fell off 'completely. It was observed that, at first the surface layers of the wart began to degrade, exposing large erythematous papules. Then interestingly, the warts did not just diminish in size by flaking or peeling, they diminished at the point of attachment on the subject's epidermis and fell off still somewhat intact with no sequela scarring. In an ongoing, long term in-vivo study of this invention, which began with the first seven subjects in April of 1989 and has now spanned 7 years, approximately 100 infectious outbreaks^ have been treated with the medicine in different concentrations, as described previously. In all cases the surprisingly good results were the same: 1. Pain disappears in minutes; 2. No outbreak occurs when the composition is applied at the prodrome stage; 3. The outbreak resolves in twenty-one hours when applied at the vesicular stage. IN VITRO TESTING Laboratory testing was undertaken at the University Of Chicago, Clinical Microbiology Laboratories to determine, inhibitory activity in vitro of the medical treatment and composition (medicine) . The laboratory testing was conducted by the Associate Director, PhD, and Associate Professor of Pathology. The in vitro testing of the medical composition, referred to as the ADrugs below, yielded surprisingly good results. It was determined that the medical treatment and composition had unexpectedly, surprising excellent inhibitory activity on HSV 1 and HSV 2. It was stated by the pathologist, that he had tested "hundreds" of other compounds and had never seen anything as good as what this compound did. The following are the tests of the medicine that were conducted and results that were obtained at The University of Chicago. For ease of interpreting some of the scientific data Dramatically in size by approximately 3mm per day while the medicine was applied to the wart and on the fifth day fell off completely. It was observed that, at first the surface layers of the wart began to degrade, exposing large erythematous papules. Then interestingly, the warts did not just diminish in size by flaking or peeling, they diminished at the point of attachment on the subject's epidermis and fell off still somewhat intact with no sequela scarring. In an ongoing, long term in- vivo study of this invention, which began with the first seven subjects in April of 1989 and has now spanned 7 years, approximately 100 infectious outbreaks have been treated with the medicine in different concentrations, as described previously. In all cases the surprisingly good results were the same: 1. Pain disappears in minutes; 2. No outbreak occurs when the composition is applied at the prodrome stage; 3. The outbreak resolves in twenty-one hours when applied at the vesicular stage. IN VITRO TESTING Laboratory testing was undertaken at the University Of Chicago, Clinical Microbiology Laboratories to determine inhibitory activity in vitro of the medical treatment and composition (medicine). The laboratory testing was conducted by the Associate Director, PhD, and Associate Professor of Pathology. The in vitro testing of the medical composition, referred to as the ADrugs below, yielded surprisingly good results. It was determined that the medical treatment and composition had unexpectedly, surprising excellent inhibitory activity on HSV 1 and HSV 2. It was stated by the pathologist, that he had tested "hundreds" of other compounds and had never seen anything as good as what this compound did. The following are the tests of the medicine that were conducted and results that were obtained at The University of Chicago. For ease of interpreting some of the scientific data and test results, the following definitions apply: AMEMs pertains to Minimal Essential Medium. This is the culture medium used in laboratories for growing the cells upon which tests will be run. AFibroblasts is a mesenchyme human cell (a cell found in connective tissue, blood, bone, lymphatics, and cartilage). AlCsoA pertains to the Inhibitory Concentrate. For this testing a 50% endpoint was selected, as is typical. The number following indicates the greatest dilution below 50%. Therefore it is the definition of the endpoint. If an area under a dilution is left blank, it indicates that there may have been toxicity at that dilution, the test may not have been worth reading, or no interpretable data is available. If an area under dilution is marked with a hyphen (-), it indicates that there are no plaques and there is a successful inhibition of herpes (HSV). EXAMPLES 15-18 In these in vitro tests, the following drugs (medicine) was used: Drug # 1. = Benzalkonium chloride surfactant in an aqueous solution at a ratio of 1:750. The surfactant in the aqueous solution was filtered before use and diluted in an equal volume of 2X MEM to give a 1:1500 dilution in IX MEM. Drug # 2 = Echinacea powder (photochemicals) in an aqueous solution. This preparation was extracted by warm infusion in sterile water. The extracted phytochemicals was centrifuged and filtered before use. The filtere'd phytochemicals were diluted in an equal volume of 2X MEM to give the undiluted preparation in IX MEM. Drug # 3 = Echinacea powder (phytochemicals) were extracted and combined with benzalkonium chloride surfactant by a cold infusion process. The combined preparation was centrifuged and filtered before use and diluted in an equal volume of 2X MEM to give the undiluted preparation in IX MEM. 1. Three 24-compartment plates were inoculated with fibroblasts. Three different extractions (for comparison) in five concentrations of the composition were used to screen for antiviral activity in concentrations of: undiluted, 1:2, 1:4, 1:8, and 1:16 in IX MEM. There were four control compartments on each plate containing MEM without drug. 2. The growth media was removed from the compartments and 200ul of HSV-1 was added to each compartment of the upper half of each plate. HSV-1 was diluted 1:5000 (2.0 ul of stock HSV-1 in 10 mL of MEM). The virus titer was 3xl06 per mL. Also, 200ul of HSV-2 was added to each compartment of the lower half of each plate. HSV-2 was diluted 1:2,000 (5.0 ul of stock HSV-2 in 10 mL of MEM). The virus titer was 6xl05 per mL. 3. The plates were incubated at 37°C for two hours. . * • -k •' 4. The inoculum was removed and one mL of the MEM containing Drugs #1-3 were added to the four compartments. The concentration of the drug compared to the MEM is indicated below. Table 1 (Table Removed) 5. Results: HSV-1, liquid overlay, Drug added immediately after virus absorption. Plate 1, Drug #1 contaminated with bacteria! No growth, maybe debris. Plate 2, Drug #2 contaminated with bacteria! No growth, maybe debris. Plate 3, Drug #3 The results are indicated in Tables 2 and 3 below. Table 2 - Drug #3 HSV 1 Test Results (Table Removed) Table 3 - Drug #3 HSV 2 Test Results (Table Removed) slight toxicity. very small plaques Comments: Testing with the medicine (Drug #3) provided excellent results. The cells look fine with no contamination. At the lower dilutions, the preparation may be toxic to some of the cells. This preparation was unexpectedly successful in its inhibitory activity. •» EXAMPLES 19-22 Three 24-compartment plates were inoculated with fibroblasts and the following drugs. Test Drug #1A = Benzalkonium chloride surfactant in an aqueous solution. The benzalkonium chloride surfactant was prepared by making a 1:375 dilution in water (32ul in 12.0 mL of sterile water). This was filtered before use. This was diluted in an equal volume of 2X MEM to give 1:750 dilution in 1XMEM. The dilution was done to maintain the ratio. Test Drug #2A = Echinacea purpurea powder (phytochemicals} in an aqueous solution. This preparation was a 50 mg/mL solution (300 mg in 6.0 mL of water) of Echinacea purpurea powder in sterile water. The mixture was vortexed and refrigerated for four hours. The Echinacea powder preparation was centrifuged at 3500 rpm for 15 minutes at 10° C and filtered before use and then diluted in an equal volume of 2X MEM to give the undiluted preparation in 1XMEM. Test Drug #3A = Echinacea purpurea powder(phytochemicals) dissolved in benzalkonium chloride surfactant. This preparation was a 50 mg/mL solution (300 mg in 6.0 mL of benzalkonium chloride, 1:375). The mixture was vortexed and refrigerated for four hours. The phytochemical and surfactant mixture was centrifuged at 3500 rpm for 15 minutes at 10° C and filtered before use, and then diluted in an equal volume of 2X MEM to give •the undiluted preparation in 1XMEM. 1. Three plates were used to screen the three drug preparations. The concentrations needed to screen for antiviral activity were 1:2, 1:4, 1:8, and 1:16 in IX MEM. There were four control compartments on each plate containing MEM without drug. 2. The growth media was removed from the compartments and 200ul of HSV-1 was added to each compartment of the upper half of each plate. HSV-1 was diluted 1:5000 (2.0 ul of stock HSV-1 in 10 mL of MEM). The virus titer was 3xl06 per mL. 3. The plates were incubated at 37°C for four hours. 4. The inoculum was removed and one mL of the MEM containing drugs #1A-3A were added to the four compartments. Table 4 (Table Removed) 5. Results: HSV-1, liquid overlay, composition added immediately after virus absorption. Table 5 - Drug #1A - HSV 1 Test Results (Table Removed) Comments: These compartments have a fine precipitate over the cells. Benzalkonium chloride probably precipitates with the protein in the medium. Table 6 - Drug #2A - HSV 1 Test Results (Table Removed) Comments: Although there were some plaques, they were very small. Table 7 - Drug #3A - HSV 1 Test Results (Table Removed) Comments: Although there was some toxicity, this drug was very successful in inhibiting the virus, there did not appear to be any plaques. EXAMPLES 23 - 27 Four 24-compartment plates were inoculated with fibroblasts. Test Drug #1B = Benzalkonium chloride surfactant in an aqueous diluent. The benzalkonium chloride was prepared by making a 1:1000 dilution in water (lOul in 10.0 mL of sterile water). This was filtered before use and diluted in an equal volume of 2X MEM to give 1:2000 dilution in 1XMEM.(500 ul drug plus 500 ul of 2X MEM) . Test Drug #2B = Echinacea purpurea powder (phytochemicals) in an aqueous solution. This preparation was a 50 mg/mL solution (250 mg in 5.0 mL of water) of Echinacea purpurea powder in sterile water. The mixture was vortexed and refrigerated for four hours. This Echinacea powdered preparation was centrifuged at 3500 rpm for 15 minutes at 10° C and filtered before use, and diluted in an equal volume of 2X MEM to give the undiluted preparation in 1XMEM.(500 ul drug plus 500 ul of 2X MEM). Test Drug #3B = Echinacea purpurea powder (phytochemicals) dissolved in benzalkonium chloride surfactant. This preparation was a 50 mg/mL solution (250 mg in 5.0 mL of- benzalkonium chloride, 1:1000). The mixture was vortexed and refrigerated for four hours. The Echinacea phytochemicals and surfactants were centrifuged at 3500 rpm for 15 minutes at 10° C and filtered before use, and then diluted in an equal volume of 2X MEM to give the preparation in 1XMEM (500 ul drug plus 500 ul of 2X MEM). Test Drug #4B = Echinacea purpurea powder (phytochemicals) in an aqueous solution (diluent) and then mixed with benzalkonium chloride surfactant at a ratio of 1:1000. This preparation was a 50 mg/mL solution (250 mg in 5.0 mL in 5.0 mL of water) of Echinacea purpurea powder in sterile water. The mixture was vortexed and refrigerated for four hours. The aqueous phytochemicals were centrifuged at 3500 rpm for 15 minutes at 10° C and filtered before use. This .preparation was diluted in an equal volume of benzalkonium chloride at a ratio of 1:1000, to get the Echinacea-benzalkonium chloride mixture. This mixture was diluted with equal volume of 2X MEM to give the 1:4 preparation in 1XMEM (500 ul drug #1 and 250 ul drug #2 plus 500 ul of 2X MEM) . 1. Four plates were used to screen the four drug preparations. The concentrations needed to screen for antiviral activity were 1:20, 1:40, 1:80, and 1:160 and 1:320 in IX MEM. There were four control compartments on each plate containing MEM without drug. 2. The growth media was removed from the compartments and 200ul of HSV-1 was added to each compartment of the upper two rows of each plate. HSV-1 was diluted 1:5000(2.0 ul of stock HSV- 1 in 10 mL of MEM) . The virus titer was 3xl06 per mL. Also, 200ul of HSV-2 was added to each compartment of the lower half of each plate. HSV-2 was diluted 1:2,000 (5.0 ul of stock HSV-2 in 10 mL of MEM). The virus titer was 6xl05 per mL. 3. The plates were incubated at 37°C for four hours. 4. The inoculum was removed and one mL of the MEM containing drugs # 1-4 was added to the four compartments. Table 8(Table Removed) 5. Results: HSV-1, liquid overlay, drugs added immediately after virus absorption. Table 9 - Drug #1B - HSV 1 Test Results (Table Removed) Comments: Slightly toxic, test was difficult to read. HSV-2, liquid overlay, drugs added immediately after virus absorption. Table 10 - Drug #1B -'HSV 2 Test Results (Table Removed) Comments: Test was too toxic to give a good reading. Table 11 - Drug #2B - HSV 1 Test Results (Table Removed) Comments: Small plaques. Table 12 - Drug J»2B - HSV 2 Test Results (Table Removed) Table 13 - Drug #3B - HSV 1 Test Results (Table Removed) Comments: Although there was some toxicity, drug very successful there did not appear to be any plaques. Table 14 - Drug #3B - HSV 2 Test Results (Table Removed) Comments: A difficult test to get a really good reading. However the drug has successful inhibitory activity. Table 15 - Drug #4B - HSV 1 Test Results (Table Removed) Comments: Too toxic at the higher levels. Nonetheless, there was inhibitory activity at 1:320 Table 16 - Drug #4B - HSV 2 Test Results (Table Removed) Comments: Toxicity probably due to the benzalkonium chloride. The drug at the 1:320 dilution showed very strong inhibitory activity. The in vitro tests of Examples 23-27 used raw materials which were not refined. Nevertheless, the tests demonstrate surprisingly good viral inhibitory activity and a probable synergy between the constituents. In the preceding in vitro tests where Drugs #3, 3A and 3B, were Echinacea purpurea phytochemicals extracted and combined with benzalkonium chloride surfactant, the resultant medicine, demonstrated the greater antiviral activity, and most remarkably demonstrated a synergy between the components: Echinacea purpurea and benzalkonium chloride. This can possibly be explained by a shared stability and enhanced reactivity between the two components. The benzalkonium chloride in the synergistic mixture exhibited a lesser degree of toxicity and the synergistic combination (medicine) exhibited a greater degree of antiviral activity, particularly with HSV-2. SURFACTANTS While benzalkonium chloride is the preferred surfactant for best results, in some circumstances it may be desirable to use other quanternay ammonium surfactants or other surfactants. The quaternary ammonium compound can be dicocodimonium chloride, which is also known as dicoco alkyldimethyl, chlorides or dicoco dimethyl ammonium chloride or Di-C8-18-alkyldimethyl, chlorides. This can be used in combination with isopropanol, such as 20-30% isopropanol. The preferred source of quaternary compound comprises: 70-80% quaternary ammonium compound and less than 0.03% methyl chloride, has a specific gravity of about 0.87 at 115 degrees F, a vapor pressure of 33 mm/Hg at 68 degrees F, an initial boiling point of 180 degrees F at 760 mm/Hg, and a volatility of 20-30%, and is produced under the brand name CarSpray 300 by Witco Corporation, Dublin, Ohio, USA. The quaternary compound can provide disinfecting qualities and serves as a fungicide to teat fungus and yeast infections. Other quaternary ammonium compounds may be useful, such a:.-, produced under the brand name Jet Quat 2C-75 by Jetco Chemicals, Inc. of Corsicana, Texas, USA, or produced under the brand name:; Carspray 400 and Carnauba Spray 200 by Witco Corporation, Dublin, Ohio, USA, or containing 9% denatured ethyl alcohol such as sold under the brand name ETC 2125M by Stephan Company, Northfield, Illinois, USA, or the following MAQUAT products comprising n-alkyl dimethyl benzyl ammonium chloride produced by Mason Chemical Company, Arlington Heights, Illinois, USA. LC-12S (67% C12, 25% C14, 7% C16, 1% C18), MC 1416 (5% C12, 60% C14, 30% C16, 5% C18), MC1412 (40% C12, 50% C14, 10% C16), SC-18 stearyl paste or flake (5% C16, 95% C18), TC-76 or MQ-2525 (5% C12, 60% C14, 30% C16, and 5% C18) and MC6025-50% (25% C12, 60% C14 and 15% C16). Jet Quat 2C-75 comprises: 50-75% dicoco dimethyl quaternary ammonium chloride, 20-50% isopropyl alcohol, has a specific gravity of 0.88 and a boiling point of 180 degrees F. CarSpray 400 comprises: 55-65% quaternary ammonium compounds, 20-30% amines, C14-18 & C16-18 unsaturated, alkyl, ethoxylated, 10-20% isopropanol, and less than 0.03% methyl chloride, and has a specific gravity of approximate 0.88 at 75 degrees, F, a vapor pressure of 33 mm/Hg at 68 degrees F, an initial boiling point of 180 degrees F at 760 mm/Hg, and a volatility of 10-20%. Carnauba Spray 200 comprises: 50-60% quaternary ammonium compounds, 10-20% isopropanol, 15-25% water, 1-10% alkoylated carnauba wax, and less than 0.03% methyl chloride, and has a specific gravity of about 0.90 at 80 degrees F, a vapor pressure of 33 mm/Hg at 68 degrees F, an initial boiling point of 180 degrees F at 760 mm/Hg, and a volatility of 20-40%. Nonionic surfactants are surface-active compounds which do not ionize in water solution. Often times these possess hydrophilic characteristics by virtue of the presence therein or an oxygenated chain (e.g., a poly-oxyethylene chain), the lyophilic portion of the molecule being derived from fatty acids, phenols, alcohols, amides or amines. Exemplary compounds are the poly-(ethylene oxide) condensates of alkyl phenols, e.g. the condensation product formed from one mole of nonyl phenol and ten moles of ethylene oxide, and the condensation products of aliphatic alcohols and ethylene oxide, e.g. the condensation product formed from 1 mole of tridecanol and 12 moles of ethylene oxide. The nonionic surfactants can comprise phenol ethoxylates comprising a condensate product of ethylene oxide and an alkyl phenol or an aliphatic alcohol. The nonionic surfactants preferably comprise nonophenol ethoxylate such as T-DET, and/or octaphenol ethoxylate. The nonionic surfactants are reaction products of ethylene oxide and nonolphenol and/or octalphenol. The ratio of the phenol to the ethylene oxide can range from 2:20 to 4:16 and preferably is about 8:12. Nonionic synthetic surfactants can comprise nonionic detergents. Nonionic synthetic surfactants can also be formed by condensing ethylene oxide with a hydrophobic base formed by the condensation of propylene oxide with propylene glycol. The hydrophobic portion of the molecule which, of course, exhibits water insolubility has a molecular weight of from about 1200 to 2500. The addition of polyoxyethylene radicals to this hydrophobic portion tends to increase the water solubility of the molecule as a whole and the liquid character of the product can be retained up to the point where polyoxyethylene content is about 50% of the total weight of the condensation product. Other nonionic synthetic surfactants can include: the polyethylene oxide condensates of alkylphenols, e.g. the condensation products of alkylphenols or dialkylphenols wherein the alkyl group contains from about 6 to 12 carbon atoms in either a straight chain or branched chain configuration, with ethylene oxide. The ethylene oxide can be present in amounts equal to 8 to 25 moles of ethylene oxide per mole of alkylphenol. The alkyl substituent in such compounds can be derived from polymerized propylene, diisobutylene, n-octene, or n-nonene. Nonionic surfactants can also be produced from the condensation of ethylene oxide with the reaction product of propylene oxide and ethylenediamine, e.g. compounds containing from about 40% to about 80% polyoxyethylene by weight and having a molecular weight of from about 5,000 to about 11,000 resulting from the reaction of ethylene oxide groups with a hydrophobic base comprising the reaction product of ethylenediamine and excess propylene oxide; the base having a molecular weight on the order of 2,500 to 3,000. Other nonionic surfactants include the condensation product of aliphatic alcohols having from 8 to 18 carbon atoms, in either-straight chain or branched chain configuration, with ethylene oxide, e.g. a coconut alcohol ethylene oxide condensation having from 10 to 30 moles of ethylene oxide per mole of coconut alcohol, and the coconut alcohol fraction having from 10 to 14carbon atoms. Further nonionic surfactants include long chain tertiary ^amine oxides corresponding to the following general formula: RiR3R2N lo wherein Rl is an alkyl radical of from about 8 to 18 carbon atoms, and R2 and Rj are each methyl or ethyl radicals. The arrow in the formula is a conventional representation of a semi-polar bond. Examples of amine oxides suitable for use include: dimethyldodecylamine oxide, dimethyloctylamine oxide, dimethyldecylamine oxide, dimethyltetradecylamine oxide, and dimethylhexadecylamine oxide. Other nonionic surfactants can include: long chain tertiary phosphine oxides corresponding to the following general formula RR'R"P\|0 wherein R is an alkyl, alkenyl or monohydroxyalkyl radical ranging from 10 to 18 carbon atoms in chain length and R1 and R" are each alkyl or monohydroxyalkyl groups containing from 1 to 3 carbon atoms. The arrow in the formula is a conventional representation of a semi-polar bond. Examples of suitable phosphine oxides are: dimethyldodecylphosphine oxide, dimethyltetradecylphosphine oxide, ethylmethyltetradecylphosphine oxide, cetyldimethylphosphine oxide, dimethylstearylphosphine oxide, cetylethylpropylphosphine oxide, diethyldodecylphosphine oxide, diethyltetradecylphosphine oxide, dipropyldodecylphosphine oxide, bis-(2-hydroxymethyl) dodecylphosphine oxide, bis-(2-hydroxyethyl)dodecylphosphine oxide, (2-hydroxy propyl)methyltetradecylphosphine oxide, dimethyloleylphosphine oxide, and dimethyl-(2-hydroxydodecyl)phosphine oxide. In some circumstances it may be useful to use other surfactants such as: another cationic surfactant, an ampholytic surfactant or a zwitterionic surfactant. The cationic surfactants can include cationic detergents. The cationic surfactants comprise compounds which ionize in an aqueous medium to give cations containing the lyophilic group. Typical of these compounds are the quaternary ammonium salty which contain an alkyl group of about 12 to about 18 carbon atoms, such as lauryl benzyl dimethyl ammonium chloride. Ampholytic surfactants are compounds having both anionic and cationic groups in the same molecule. Exemplary of such compounds are derivatives of aliphatic amines which contain a -long chain of about 8 to about 18 carbon atoms and an anionic water solubilizing group, e.g., carboxysulfo, sulfo or sulfato. Examples of ampholytic detergents are: sodium-3-dodecylaminopropane sulfonate, sodium-N-methyl taurate, and related substances such as higher alkyl : disubstituted amino acids, betaines, thetines, sulfated long chain olefinic amines, and sulfated imidazoline derivatives. Zwitterionic surfactants can include synthetic detergents. Zwitterionic surfactants are generally derivatives of aliphatic quaternary ammonium compounds in which the aliphatic radical can be a straight chain or branched and wherein one of the aliphatic substituents contains from about 8 to 18 carbon atoms and one contains an anionic water solubilizing group, e.g., carboxy, sulfo, or sulfato. Examples of compounds falling within this definition are: 3-(N,N-dimethyl-N-hexadecyl ammonio)-propane-1-sulfonate and 3-(N,N-dimethyl-N-hexadecyl ammonio)-2-hydroxy propane-1-sulfonate. TREATMENT The preferred medical treatment comprises a method for u^se in treating herpes virus or other infectious diseases by *r resolving the physical symptoms of an infectious outbreak of herpes simplex virus 1 or 2 (HSV 1 or HSV 2) or other infectious microbial diseases within 10-30 hours. This is accomplished by topically applying the above described preferred antimicrobial compound (medicine) on the infected area of the herpes simplex virus or other infectious microbial disease, and maintaining the antimicrobial compound on the infected area for 10-30 hours. The antimicrobial compound (medicine) can be applied in the manner previously described and most preferably coats the infected area. Desirably, the infected area is rinsed (washed) and dried to remove any soap or residue on the infected area before the antimicrobial compound (medicine) is applied. Preferably, vesicular eruption of herpes virus are resolved in 19-24 hours and herpes lesions are healed by maintaining the above described most preferred medicine on the infection for 19-24 hour. The many advantages and uses of the herbaceous botanical products and method of manufacturing the herbaceous botanical products, include but are not limited to: 1. Superior results in ending the pain of herpes simplex viral infections and other microbial infections. 2. Outstanding performance in rapidly resolving outbreaks of herpes simplex virus and other microbial diseases. 3. Potentially saves lives of neonates and animals. 4. Reduces risk of blindness in newborns. 5. Reduces worldwide economic loss from herpes and other microbial diseases. 6. Resolves the serious emotional and mental anguish of herpes sufferers. 7. Readily available materials (ingredients). 8. Economical. 9. Safe. 10. Easy to use. 11. Dependable. 12. Effective. Although embodiments of the invention and examples have been shown and described, it is to be understood that various modifications and substitutions, as well as other uses, rearrangements of parts, components, and process steps, methods of manufacture, and treatments, can be made by those skilled in the art without departing from the novel spirit and scope of this invention. We claim: 1. A process for preparing a synergistic herbal pharmaceutical composition comprising: blending from 2% to 90% by wt. of an extract from the herb of the genus Echniacea from 0.005% to 0.8% by wt. surtefctant of the kind as herein described and the balance, if any, adding a diluent and a carrier. 2. A process as claimed in claim 1 wherein the said surfactant is benzalkonium halide. 3. A process as claimed in claim 1 wherein the said surfactant is selected from nonionic surfactant, quanternary ammonium surfactants, nonionic synthetic surfactants, cationic surfactants, ampholytic surfactant or zwitterionic surfactant. 4. A process as claimed in claim 2 wherein the proportions in which the ingredients are blended are from 40% to 60% by wt. of an extract from the herb of the genus Echniacea from 0.02% to 0.30% by wt. benzalkonium halide and form 20% to 60% by wt. water. 5. A process as claimed in any one of the preceding claims, characterized in that said benzalkonium halide consists of benzalkonium chloride. 6. A process as claimed in any one of the preceding claims wherein the extract from the herb of the genus Echniacea is obtained from at least one of the following: Echinacea purpurea, Echinacea angustifolia, Echinacea pallidae, Echinacea vegetalis or Echinacea atribactilus. 1. A process as claimed in claim 6 wherein the extract is obtained from Echinacea purpurea. 8. A process as claimed in any one of the preceding claims wherein the extract from the herb of the genus Echniacea comprises phytoproducts selected from the group consisting of: echinacen; echinacen B; echinaceine; echinacoside; caffeic acid pester; echinolone; enzymes; glucuronic acid, inulini inuloid; pentadecadiene; polyacelylene compounds polysaccharides, arabinogalactan; rhamnose; tannins; PSI (a 4-0- methylglucoronoarabinoxylan, Mr 35 Kd); PSII ( an acid rhamnoarbinogalactan, Mr 450 Kd), cynarin; 1, 5-di-O- caffeoylquinic acid; chicoric acid, 2, 3-0-di-caffeoyltartaric acid, borneol; bornyl acetate, pentadeca -8 (z) - en-zone; germacrene D; caryophyllene; caryophyllene epoxide; anthocyanin, pyrrolizidine alkaloid, lipophilic amide; isobutylamide; plyacetaylene; anthocyanin; 3-0-B-D-glucopyranoside; 3-0-(6-0- mabonyle)-B-D-glucopyranoside; tussilagine; isotussilagine; isomeric dodeca isobutylamide; tetraenoic acid or carophylenese. 9. A process as claimed in any one of the preceding claims extract from the herb of the genus Echniacea comprises phytoproducts comprising by weight based upon the total weight of the product: from 0.3% to 9& echinacoside; from 0.1% to 7% by wt. PSI (4-0-methylglucoronoararabinoxylan, Mr 35 Kd ) and PSII (acid rhamnoarabinogalactan, Mr 450 Kd), from 0.1% to 10% by wt. cynarin (1, 5-di-o-caffeoylquinic acid) and chioric acid (2, 3-0-di-caffeoyltartaric acid) and derivatives thereof, from 0.2% to 4% by wt. echinolone, from 0.2% to 6% by wt. echinacin B, from 0.1% to 6% by wt. echniaceine, from 2% to 7% by wt. anthonocyanins comprising cynanidin 3-0-B-d-glucopyranoside and 3-0-(6-0-malonyl)- B-D-glucopyranoside; from 0.01% to 0.06% by wt. pyrrolizidine alkaloids comprising tussilagine and isotussilaine; from 0.003% to 0.009% by wt. isomeric dodeca isobutyalamides and tetraoenoic acid and from p.01% to 2% caryophylenes. 10. A process for preparing a synergistic herbal pharmaceutical composition substantially as herein desqribed with reference to the foregoing examples.

Full Text

This invention relates to a process of preparing a synergistic herbal pharmaceutical composition.
Background of the Invention
The present invention relates to herbaceous botanical products and methods of manufacturing the same.
Herpes simplex virus (HSV) commonly referred to as herpes virus or herpes, is an infectious disease which has reached crisis proportions nationally with estimated numbers of infected people at 70%-80% of our population as reported by the American Societal Health Association (ASHA) and growing annually by 500,000 people. There are two common types of herpes: herpes simplex virus 1(HSV 1) and herpes simplex virus 2(HSV 2).
Herpes enters the human body through minuscule breaks in the epidermal tissue usually by contact with an infected host and is marked by eruption of one or more vesicles, usually in groups, following an incubation period of approximately four days. Typically the course of the infectious outbreak initiates with the prodromal stage; advancing to vesicular eruption; followed by ulceration, coalescing; resolution; and the latency period. The outbreak can last for several weeks and on average lasts two-three weeks. In some immune compromised individuals the outbreak can last for months. The vesicles can appear anywhere on the skin or mucosa, typically appearing on the lips as cold sores, glands, oral mucosa, conjunctiva and cornea, genitalia, anal mucos and peri-anal tissue.
Herpes symptoms includes: inguinal swelling, pain, fever, malaise, headaches, muscle aches, and swollen glands. Some individuals who have the trigeminal nerve compromised with oral herpes, have excruciating facial pain, difficulty swallowing, eating and facial swelling. Individuals with the sacral nerve affected have severe upper leg pain, swelling and great difficulty walking.
Herpes simplex virus (HSV) infection is recrudescent, residing in the nerve ganglia, then recurring due to some, as yet unknown, stimulus. Recurrent herpetic infections can be precipitated by almost anything, including: overexposure to
'sunlight; nutritional deficiencies; stress, menstruation; immunosuppression; certain foods; drugs; febrile illness; etc. Recently herpes virus was isolated from cardiac tissue.
HSV 1 and HSV 2 infections pose very serious health threats often causing: blindness; increased cancer risk of the cervix; aseptic meningitis and encephalitis; neonatal deaths; viremia; etc. The devastating effects of this disease, go well beyond the medical scope of human suffering. HSV is responsible for serious psychological and emotional distress as well as substantial economic loss to the nation and the world.
Various treatments for herpes have been proposed and have included topical application of such agents as povodone-iodine, idoxuridine, trifluorothymidine, or acyclovir. Such treatments have met with varying degrees of success. Most prior treatments have proven disappointing. Acyclovir, taken orally for systemic treatment of HSV, is somewhat effective. However, acyclovir is only successful in interrupting the replication of the virus. It is not successful in treating an infectious outbreak either systemically or topically. Strains resistant to acyclovir have been reported. Individuals with Auto Immune Deficiency Syndrome (AIDS) are seriously immune-compromised and suffer especially debilitating outbreaks of HSV. Additionally, AIDS individuals may carry acyclovir resistant strains of HSV, which can make acyclovir ineffective for these individuals.
It is, therefore, desirable to provide improved herbaceous botanical products and methods of manufacturing the same which overcomes most if, not all of the preceding problems, and provides for other uses.
SUMMARY OF THE INVENTION
An improved herbaceous botanical product is provided
comprising a plant and a surfactant. /Advantageously, the plant
.herbaceous botanicall/of the genus Echinacea and -h--
surfactant comprises benzalkonium halide.
The herbaceous botanical product can comprise by weight: from about 2% to about 90% of a herbaceous botanical of the genus Echinacea; and fr6m about 0.005% to about 0.8% benzalkonium
'caffeoylquinic acid)and chloric acid (2, 3-0-di-caffeoyltartaric acid) and derivatives thereof;
from about 0.2% to about 4% echinolone;
from about 0.2% to about 8% echinacin B;
from about 0.1 to about 6% echinaceine;
from about 2% to about 7% anthonocyanins comprising cynanidin 3-0-B-D-glucopyranoside and 3-0-(6-0-malonyl)-B-D-glucopyranoside;
from about 0.01% to about 0.06% pyrrolizidine alkaloids comprising tussilagine and isotussilagine;
from about 0.003% to about 0.009% isomeric dodeca isobutyalamides and tetroenoic acid; and
from about 0.01% to about 2% caryophylenes. Desirably, the herbaceous botanical products described above can be used as a medicament. Advantageously, the herbaceous botanical products described above can be used in the preparation of a product for the treatment of a disease, such as: herpes simplex virus 1, herpes simplex virus 2, varicella zoster virus (herpes zoster), cytomegalovirus, human immunodeficiency virus (HIV), or epstein barr; viral influenza (flu), shingles, geniculate zoster, herpes keratitis, chicken pox,
cytomegalovirus, papilloma • virus, viral ,, parainfluenza,
, adenovirus, viral encephalitis, viral menijgitus, arbovirus,
arenavirus, picornavirus, coronavirus, syntialvirus, viral infections, common colds caused by virusesngivostomatitis, roseola infantum. organ transplant rejection, pneumonia, infectious mononucleosis, uveitis, retinitis, human papilloma virus, cervical carcinoma, vaginal carcinoma, vulvovaginitis, human herpes IV, and Kaposi's sarcoma.
The herbaceous botanical products described above can be manufactured or produced by blending or mixing the above-designated parts of the herbaceous botanical products.
The herbaceous botanical products can be used in conjunction with an improved medical treatment and medicine which, when applied in the topical manner, rapidly relieves pain and heals lesions of herpes virus. Advantageously, the improved medical. treatment and medicine are safe, inexpensive and effective. The
'improved medicine, also referred to as Viracea, comprises a novel medical composition, formulation, antimicrobial compound and .•solution. The new antimicrobial medical treatment and microbicidal medicine are successful in treating primarily herpes simplex virus (HSV 1 & HSV 2) topically and can be useful in treating other herpes related microbial infections including, but not limited to: varicella zoster virus (herpes zoster) and cytomegalovirus. In some circumstances, it may be useful to use the novel medicine systemically.
Advantageously, the improved medical treatment and medicine of the present invention yielded unexpected, surprisingly good results. Initial, topical, in vivo testing, demonstrated relief from pain in minutes and speedy total resolution of vesicular eruption in all individuals tested. When the inventive medical treatment and medicine are applied at the prodromal stage, the infection is interrupted and no further outbreak occurs. In vitro testing of the novel medical treatment and medicine demonstrated extremely surprising inhibitory effects on herpes virus. Desirably, the novel medicine is made from readily available, over the counter (OTC) chemicals or products and provides a safe comfortable, economical and user - friendly treatment.
While the novel medicine and antimicrobial compound is particularly useful in dramatically inhibiting herpes virus simplex, it may be useful in treating other microbial diseases (microbe-causing diseases)such as: human immunodeficiency virus infection (HIV), Epstein barr, papilloma virus, cellulitis, staphylococci, streptococci, mycobacteria, influenza, parainfluenza, adenoviruses, encephalitis, meningitis, arbovirus, arenavirus, anaerobic bacilli, picornavirus, coronavirus and synsytialvirus, as well as varicella zoster virus and cytomegalovirus.
This easy to use microbicide solution provides a moderately 'water "resistant coating]upon application to either the prodromal tissue" or the erythematous vesicular herpes lesion. Upon contact, there is a slight tingling effect. Within minutes of application, the pain of the infection resolves. Gradually, inguinal swelling subsides, fever, malaise, body aches, and nerve involvement
subsides. Typically, within, twenty-one hours all external symptoms and physical manifestations of infection are resolved -ind the vesicle is dried and resolved. A particularly surprising, beneficial effect provided by this inventive medicine, is that when it is applied at the first sign of outbreak, the prodromal stage, all symptoms and signs of further infectious outbreak stops! No eruptions appear or any further escalation of symptoms of the infection. The outbreak literally stops!
Desirably, the novel medicine (medical composition) includes microbe inhibitors which inhibit, suppress and stop microbial infections from microbe-causing diseases. The microbe inhibitors comprise antimicrobial isolates, botanical extracts or phytochemicals, of at least a portion of one or more of the special plants listed below. The microbe inhibitors can comprise viral inhibitors to inhibit viral diseases, such as: herpes simplex virus 1 (HSV 1), herpes simples virus 2 (HSV 2), varicella zoster virus (herpes zoster), cytomegalovirus, HIV,
epstein barr, papilloma virus, viral influenza, viral
XV parainfluenza, adenovirus, viral encephalitis, viral menigitus,
arbovirus, arenavirus, picornavirus, coronavirus, and synstialvirus. The microbe inhibitors can also comprise bacterial inhibitors to inhibit bacterial diseases, such as: cellulitis, staphylocci, streptoci, mycolbacteria, bacterial encephalitis, bacterial meningitis, and anaerobic bacilli. In some circumstances, the microbe inhibitors can include fungi inhibitors.
Better results are obtained if Echinacea or other plants are not used in the medicine in their raw, untreated and uncut state. For even better results, the medicine can exclude: Arabinose, betaine, cellulose, copper, fructose, fatty acids,
galactose, glucose, iron, potassium, protein, resin, sucrose,
sulfur, vitamin a, vitamin The improved) medical treatment provides a novel method and process for use in treating the above infectious diseases by applying the microbial inhibitors on the microbial infected area and maintaining the microbe inhibitors on the infected area (region or surface) until the external symptoms and physical
'manifestations of the infection disappear, reside or resolve about the infected area. The medicine can be applied by ./-.praying, dabbing, dusting, swabbing, sponging, brushing, pouring, dispensing, covering, or heavily coating the medicine on the microbial infected areas, such as: oral mucosa, nasal mucosa, vagina tissue, labial tissue, anal tissue, peri-anal tissue, lips, cutaneous tissue, ocular tissue, conjunctiva, and eyelids.
While the medical treatment and medicine is particularly useful for inhibiting herpes and other infectious diseases in persons (human beings) (homo sapiens), they can also be useful for veterinary purposes for treating viral and bacterial infections and infectious diseases in animals, such as: dogs, cats, birds, horses, cows, sheep, swine (pigs and hogs), and other farm animals, as well as rodents and other animals seen in zoos.
Preferably, the improved medicine, medical composition or microbial compound is a phytochemical concentrate which is combined and simultaneously or concurrently applied with a surfactant and a carrier, solvent or diluent to provide a microbicide medicinal solution.
To this end, the interesting microbicide solution comprises
an antimicrobial detergent^surfactant, with botanical extracts.
The surfactants preferably are cationic surfactants which can1
comprise singly or any number of quaternary ammonium chlorides
having 6-18 carbons such as alkylbenzyldimethylammonium chloride,
mixtures of alkylbenzyldimethylammonium chloride,
alkyldimethyl/ethylbenzylammonium chloride, n-
alkyldimethylbenzylammonium chloride,
diisobutylphenoxyethoxyethyldimethylbenzylammonium chloride, N-
(Ci2Ci4Ci6) dimethylbenzylammonium chloride, benzalkonium chloride,
octyldecyldimethyloammonium chloride, didecyldimethylammonium
chloride, dioctyldimethylammonium chloride,
dialkyldimethylammonium chloride, dialkylmethylbenzylammonium chloride, octyldecyldimethylammonium chloride, dimethylbenzylammonium chloride, laurryldimethylbenzylammonium chloride, o-benzyl-p-chlorophenol, dideryldimethylammonium
chloride, doctyldimethylammonium chloride, alkyl dimethylbenzylammonium chloride, and preferably comprises j:lkylbenzyldimethylammonium chloride most preferably benzalkonium chloride. The range of activity of the cationic surfactant can be 5% to 90% but for best results 8% to 20%. Quaternary ammonium salts are readily available commercially. In some circumstances it may be useful to use other surfactants, such as, but not limited to: fCMSO,|gTycolic acid surfactants, enzyme surfactants, ampholytic surfactants, switterionic surfactants, and nonionic surfactants. The surfactants can comprise detergents, wetting agents, emulsifiers, defearners, and/or surface tension reducing additives.
Carriers are useful for mixing the constituents, keeping the constituents in solution, and providing an easy method of application to the affected area whether by spray, dropper, or applicator. While an aqueous solution, preferably a sterile aqueous carrier and solvent is preferred for best results, in some circumstances it may be desirable to use other liquid or solid carriers, such as: glycerin, mineral oil, silica, cottonseed oil, coconut oil, vegetable oil, seed oil, fish oil, or animal oil, alcohol, talc, corn meal, beeswax, carnauba wax, beta carotene, garlic oil, camphor oil, soluble vitamins, soluble minerals, rape seed oil, nut oils, olive oil, liposomes, ascorbic acid, evening primrose oil, pycnogenol, grape seed oil, lanolin, Ethocyn, collagen, aloe vera, bee pollen, royal jelly, chondroitin sulfate A, sea vegetables, EDTA, fatty acids, herbs, lecithin, bioflavinoids, grain oils or powders, algae, J:eas, vinegars, acidophilus, cell salts, ascorbic acids, hydra 5, \ glandulars, amino acids, psyllium, plant derivatives, or other sterile carriers.
The botanical extracts antimicrobial isolates or phytochemicals contained in this new medicine and medical treatment can be comprised of: Arabinose, betaine, copper, echinacen, echinacin B, echinacoside, echinolone, enzyrr.es, fructose, fatty acids, galactose, glucose, glucuronic acid, inulin, inuloid, iron, pentadecadiene, polyacelylene compounds, polysaccharides such as but not limited to arabinogalactan,
potassium, protein, resin, rhamnose, sucrose, sulfur, tannins, vitamins a, c, and e, xylose. For better results, the .phytochemical concentrates include the above phytochemicals, excluding Arabinose, bataine cellulose, copper, fructose, fatty acids, galactose, glicose, iron, potassium, protein, resin, sucrose, sulfer, xylose and vitamins a, c and e.
The botanical extracts, antimicrobial, isolates and phytochemicals are separated, extracted and isolated from portions of plants, such as: pimpinella anisum, myroxylon, arctostaphylos, carum, capsicum, eugenia mytacea, coriandrum, inula, allium, gentiana, juniperus, calendula, origanum, mentha labiate, commiphora, plantago, rosmarinus, ruta, baptisa, artemisa, sage, mentha, parthenium integrifolium, eucalyptus, asteriacea, and preferably from the genus Echinacea of the family Astericaea, namely, Echinacea purpurea, Echinacea angustofolium, (Echinacea pallidae), Echinace vegetalis, Echinacea atribactilus and their Echinacea pallidum and cultivars. . For best results,
I ^
the phytochemicals and antimicrobial isola|tjeb are extracts from Echinacea purpurea and Echinacea angustifolium.
The inventive technology, treatment and medicine yield very attractive, unexpected, surprisingly good and consistent results. Tests show the microbicide solution (medicine) and medical treatment to be extremely useful to: control herpes outbreaks, viral shedding, extend the latency periods of the disease, ar.u dramatically inhibit the virus, while being generally safe to the atient and the environment.
The herbaceous botanical products have many other uses,
which include, but are not limited to, the treatment of various
diseases.nerpes microbicide and treatment completely inhibits herpes virus, as well as other infectious microbial diseases, and are ..safe and non-toxic to humans, animals, and the environment.
The herpes microbicide and medicine can comprise a surfactant and an herbaceous botanical providing a botanical extract, phytochemical, antimicrobial isolate, viral isolate, microbe inhibitor, and viral inhibitor. The preferred microbicide composition can comprise: a surfactant; an aqueous diluent; and the herbaceous botanical of the genus Echinacea (E) , of the family Asteracea, species: purpurea, angustif olia, pallidae, vegetalis, atribactilus and the cultivars. Preferably, the herbanaceous botanicals are extracts and isolates comprising Echinecea phytochemicals as found in and extracted from Echinacea purpurea, E. pallidae, and E. angustofolia. For best results, the medical treatment and microbicide (medicine) comprises: a cationic surfactant; the phytochemicals from E. purpurea, and E. angustofolia; and a sterile aqueous diluent.
The surfactant provides a certain debridement of epithelial
cells with a broad spectrum of antimicrobial action. Surfactants
of this nature can comprise quaternary ammonium salts containing
6-18 carbon atoms. Preferably the quaternary ammonium salt
surfactant, is a mixture of alkyl dimethylbenzylammonium
chlorides, which can be: benzalkonium halide, benzalkonium
bromide, benzalthonium chloride and most preferably benzalkonium
chloride. The herpes treatment comprises a 100% active aqueous
solution but can also be used in concentrate. The solution can
comprise by weight various concentrations of surfactants such as
0.005% to 0.8%, preferably 0.02% to 0.30% and most preferably
0.02% to 0.26%.
The phytochemicals in the botanical Echinacea have
demonstrated impressive activity against bacteria, viruses, and some fungi. The exact mechanism is unknown. When tested topically in vivo on HSV 1 & 2, it is effective in treating herpes simplex infectious outbreaks. When tested in vitro, it showed inhibitory activity against HSV 1 & 2.
The phytochemical concentrate composition comprises the following isolated constituents, botanical extracts, microbial
of water to the combined concentrates of benzalkonium chloride and phytochemicals can comprise a range of 2:1 to 100:1 with a preferable range of 4:1 to 40:1, and for best results can comprise a ratio of 6:1 to 20:1.
For best results, the improved microbicidal treatment and medicine (microbicide) for herpes, comprises by weight: 0.02% to 0.3% benzalkonium chloride and to avoid toxicity preferably less than 0.26%; 40% to 60% Echinacea phytochemicals; and 20% to 60%, most preferably 29.74% to 59.8% sterile water.
While water is the preferred diluent and carrier, it may be desirable in some circumstances to use other carriers in order to propel the concentrate through a sprayer, or for greater solubility and efficacy. It may also be desirable in some circumstances to include a viscosity control agent. Furthermore, while it is estimated that the shelf life of the improved herpes medicine is two years, it may be necessary to add an appropriate preservative.
For preferred use, during any outbreak or physical manifestations of herpes and preferably at the first sign of the prodrome stage of tingling, itching, or irritation of herpes, the medical solution (medicine) should be applied topically on the infected area. The affected (infected) area should be dry as dry as possible depending on location of outbreak- The method of topical application of medicine can be by: spraying, dabbing, dropper, or any such method as to coat the entire affected area. The coating of the solution (medicine) should be maintained until all external symptoms completely resolve, reapplying as needed anytime the coating diminishes, for instance, after showering. Anionic soaps and anionic detergents, and especially protein content soaps can be contraindicated. Preferably, the infected area should be washed, cleaned and dried prior to application of the medicine.
CLINICAL PHARMACOLOGY
A preferred surfactant is benzalkonium chloride. Benzalkoniu~ chloride in aqueous solution is commercially available under tr.e brand name and trade mark Zephiran? distributed by Sanofi Winthrcp Pharmaceuticals (formerly Winthrop Labs). Benzalkonium chloride is

a' rapidly acting anti-infective surfactant with a moderately long duration of action. The surfactant is active against bacteria and sorfte viruses, fungi and protozoa. Bacterial spores are considered to be resistant. Solutions of benzalkonium chloride are bacteriostatic or bacteriocidal according to concentration. The exact mechanism of bacterial action of benzalkonium chloride is unknown but is thought to be due to enzyme inactivation. Activity of benzalkoniu/chloride generally increases with increasing temperature and pH. Gram-positive bacteria are more susceptible to benzalkonium chloride than gram-negative bacteria.
Unfortunately, benzalkonium chloride is inactivated by soaps, anionic detergents, serum, and certain proteins. Benzalkonium chloride has fallen out of favor in many laboratories for the above .reasons. When benzalkonium chloride was used alone and tested topically in vivo, it was ineffective for herpes simplex infectious outbreaks. When tested in vitro on HSV1 & 2 benzalkonium chloride demonstrated undesirable high levels of toxicity to the cells even at high dilutions, which is medically unacceptable.
While raw, untreated, unclean, non-isolated Echinacea is
generally ineffective to treat herpes, it has been found that some,
but not all, of the isolated constituents and botanical extracts of
Echinacea (as previously described above) provide phytochemicals,
antimicrobial isolates, botanical extracts and microbe inhibiters
which are effective in treating herpes virus and other infectious
diseases.
When the gchinacea phytochemicala (antimicrobial isolates, botanical extracts and microbe inhibitors) were mixed, combined and-applied with a surfactant, preferably benzalkonium chloride, and a sterile aqueous carrier, the results were unexpected and surprisingly good in resolving (treating) herpes virus and other infectious diseases and the effectiveness of the medicine ;microbicide) dramatically increased. When the synergistic medicine was tested topically in vivo, the herpes simplex infections were immediately-arrested. When the synergistic medicine was tested in vitro, the benzalkonium chloride surfactant was substantially less toxic and within a safe level and there was a higher level of inhibitory activity against HSV 1 & 2. The synergism interaction and mixing of

the Echinacea phytochemicals and surfactant were demonstrated and observed by viewing the rapid solubility of the components when mixed arli the slight adhesive quality created by the properties in solution. Furthermore, the chemical properties of the Echinacea phytochemicals, surfactant and aqueous carrier enhanced stabilization and increased reactivity which is useful in treating infectious diseases.
The medicine can be used in varying dilutions on: oral and nasal mucosa; vaginal tissue; labial tissue; anal and peri-anal tissue; penile tissue; cutaneous tissue; open subcutaneous tissue; and in higher dilutions on ocular infections. By varying the concentrations, the medicine may possibly be administered parenterally. The medicine may be contraindicated in vaginal or anal packs; in the ear canal; occlusive dressings; casts or ingestion and such use may produce irritation or chemical burns. It may not be advisable to use the medicine to treat anaerobic fungal infections, since some fungi may be resistant.
EXAMPLES 1 - 7
In an initial, topical application, in-vivo study that was undertaken to evaluate the effects of the medical treatment and medicine of the present invention'upon seven human test subjects who had been tested positive for HSV 1 or 2. The subjects were treated topically with the medicine comprising benzalkonium chloride surfactant in an aqueous solution (at a ratio of 1:750) in combination with the herbaceous botanical Echinacea purpurea in powdered form containing the previously listed phytochemicals. Application of the composition was made by a two-step procedure by first wetting the affected area or vesicle with the benzalkonium chloride surfactant in an aqueous solution by spraying, dabbing, or using a dropper; then applying a coating of the powdered phytochemicals over the wetted area by either swab or manually sprinkling the powder onto the infected area. An important aspect in this treatment was maintaining complete coverage of the affected area for the duration of the outbreak. Therefore, the area of outbreak was kept covered with the medical

composition by reapplying as needed.
Of the seven subjects, six were female, and one was male. At the beginning of this study, the age of the male was 38, the female subjects were ages 8, 27, 30, 32, 38, and 39. There were twelve infectious outbreaks over approximately six weeks. Nine of the outbreaks were HSV 2, genital herpes, and three were HSV1, cold sores. The 8 year old and the 27 year old females exhibited the HSV 1 (cold sores). The 30 year old, 38 year old and the 39 year old females exhibited the HSV 2 (genital herpes). The 38 year old also had a HSV I cold sore. The male exhibited HSV 2 (genital herpes). All subjects tested had a well established history of the disease and could identify the standard course of their disease. To obtain objective data, none of the test subjects knew anything about the test treatment or any action.-"of the medicine. On repeat tests, the subjects were told that there may be placebos mixed in the samples of formula.
In seven cases, the antimicrobial compound (medicine) was applied directly on tissue at the prodrome stage. In five cases, the antimicrobial compound was applied directly on erupted vesicles. The antimicrobial compound was reapplied as necessary to maintain coverage.
Observations: With each application of the medicine, each individual (test subject) reported a tingling sensation for a few seconds. They also reported that there was a substantial degree of adherence of the medicine (antimicrobial) compound to the vesicle(s) or affected area. The adherence of the composition to the epithelial tissue remained to a degree even after showering or water rinsing the area.
Results: The results of the testing of the 7 subjects with the medical treatment and medicine were unexpectedly surprisingly good and very consistent. In each case, the subject happily reported that once the composition (medicine) was applied to the affected area, the pain completely stopped within 10 to 20 minutes when nothing in the past had ever eased pain before. In the seven cases, where the compound (medicine) was applied at the prodrome stage, the subjects reported that the pain stopped, all symptoms that would have previously escalated to full outbreak
ceased and the outbreak never again occurred. All external symptoms and physical manifestations of herpes disappeared within a few hours after the medicine was applied. In the five cases, where the compound (medicine) was applied to erupted vesicles, the subjects reported that the pain stopped in minutes and the burning, itching and irritation resolved in two to four hours and the vesicles dried up and were gone in twenty-one hours. In all cases, the other more extreme, debilitating symptoms of: fever, malaise, inguinal swelling, weeping sores and painful urination stopped, once the medicine was applied.
In follow-up, where subjects had been given a supply of the composition (medicine) to test on future outbreaks, it was reported that if the initial signs of an outbreak exhibited, signaling the prodrome stage of an outbreak, the compound (medicinej_ was immediately applied by the subjects as per instructions and the outbreak was fully arrested and resolved. Significantly, it was also reported by subjects who were accustomed to experiencing several outbreaks annually, that they had remarkably longer latency periods. In a three year follow-up with one individual who had reported severe outbreaks monthly for four years prior to use of this medicine, she now reports that she has not had an outbreak in over a year since using this medicine.
Additional Observations: One human male subject reported that after the initial application during the prodrome phase of an outbreak, he showered and forgot to reapply the composition (medicine) for a period of approximately 30 hours. Consequently, several vesicles erupted and began to coalesce. The subject proceeded to reapply the composition (medicine) and thereafter kept the area well coated with the composition. Subsequently, the outbreak resolved in 21 hours in the same manner as described with the other human subjects.
Another observation indicated that the composition (medicinej may be weakened or less effective in the presence of certain proteins or soaps. One human female subject, may have been overly zealous in cleansing the affected area prior to application of the composition (medicine). This occurred during

"a third outbreak after having success with the composition (medicine.) on the two prior outbreaks. In this instance, when the -comppsition (medicine) was applied, there was no familiar tingling sensation and no relief from symptoms. Approximately 24 hours elapsed before she sought any advice and the outbreak had escalated to the full vesicular eruption stage with all the foregoing symptoms of the disease. She was instructed to thoroughly rinse any soap residue from the area, dry the area and reapply the composition (medicine) . After following the instructions, she reported that the outbreak has been fully resolved, as it had in the two prior outbreaks, by applying the medical composition.
EXAMPLES 8-13
Dermatological and Veterinary Testing
Animal testing to determine any possible dermatological allergic reaction induced by the medical composition (medicine) was undertaken. Six animal subjects were used. The animals included 3 female rabbits (ages unknown); 2 dogs (1 female 2 year old, and 1 male 9 year old); one,' 3 year old neutered male cat. In these animal tests, the above composition (medicine) was applied, in the previously stated method, to the inside of the outer ear of each animal. In all instances, the area being treated was kept coated with the compound for twenty-four hours, matching the time human subjects had used. The testing performed on the six animal subjects indicated that there were no signs of dermatological irritation or allergic reaction.
EXAMPLE 14
The above medical compound containing viral inhibitors was also tested on a papilloma virus 'caused wart on the muzzle of a two year old gelded thoroughbred horse. Papilloma virus warts are difficult to treat. The wart measured 25mm in diameter. The antimicrobial compound (medicine) was applied twice daily. The wart was then measured at each application.
Results: Quite unexpectedly, the wart decreased
dramatically in size by approximately 3mm per day while the medicine was applied to the wart and on the fifth day fell off 'completely. It was observed that, at first the surface layers of the wart began to degrade, exposing large erythematous papules. Then interestingly, the warts did not just diminish in size by flaking or peeling, they diminished at the point of attachment on the subject's epidermis and fell off still somewhat intact with no sequela scarring.
In an ongoing, long term in-vivo study of this invention, which began with the first seven subjects in April of 1989 and has now spanned 7 years, approximately 100 infectious outbreaks^ have been treated with the medicine in different concentrations, as described previously. In all cases the surprisingly good results were the same: 1. Pain disappears in minutes; 2. No outbreak occurs when the composition is applied at the prodrome stage; 3. The outbreak resolves in twenty-one hours when applied at the vesicular stage.
IN VITRO TESTING
Laboratory testing was undertaken at the University Of Chicago, Clinical Microbiology Laboratories to determine, inhibitory activity in vitro of the medical treatment and composition (medicine) . The laboratory testing was conducted by the Associate Director, PhD, and Associate Professor of Pathology. The in vitro testing of the medical composition, referred to as the ADrugs below, yielded surprisingly good results. It was determined that the medical treatment and composition had unexpectedly, surprising excellent inhibitory activity on HSV 1 and HSV 2. It was stated by the pathologist, that he had tested "hundreds" of other compounds and had never seen anything as good as what this compound did.
The following are the tests of the medicine that were conducted and results that were obtained at The University of Chicago. For ease of interpreting some of the scientific data

Dramatically in size by approximately 3mm per day while the medicine was applied to the wart and on the fifth day fell off completely. It was observed that, at first the surface layers of the wart began to degrade, exposing large erythematous papules. Then interestingly, the warts did not just diminish in size by flaking or peeling, they diminished at the point of attachment on the subject's epidermis and fell off still somewhat intact with no sequela scarring.
In an ongoing, long term in- vivo study of this invention, which began with the first seven subjects in April of 1989 and has now spanned 7 years, approximately 100 infectious outbreaks have been treated with the medicine in different concentrations, as described previously. In all cases the surprisingly good results were the same: 1. Pain disappears in minutes; 2. No outbreak occurs when the composition is applied at the prodrome stage; 3. The outbreak resolves in twenty-one hours when applied at the vesicular stage.
IN VITRO TESTING
Laboratory testing was undertaken at the University Of Chicago, Clinical Microbiology Laboratories to determine inhibitory activity in vitro of the medical treatment and composition (medicine). The laboratory testing was conducted by the Associate Director, PhD, and Associate Professor of Pathology. The in vitro testing of the medical composition, referred to as the ADrugs below, yielded surprisingly good results. It was determined that the medical treatment and composition had unexpectedly, surprising excellent inhibitory activity on HSV 1 and HSV 2. It was stated by the pathologist, that he had tested "hundreds" of other compounds and had never seen anything as good as what this compound did.
The following are the tests of the medicine that were conducted and results that were obtained at The University of Chicago. For ease of interpreting some of the scientific data
and test results, the following definitions apply:
AMEMs pertains to Minimal Essential Medium. This is the culture medium used in laboratories for growing the cells upon which tests will be run.
AFibroblasts is a mesenchyme human cell (a cell found in connective tissue, blood, bone, lymphatics, and cartilage).
AlCsoA pertains to the Inhibitory Concentrate. For this testing a 50% endpoint was selected, as is typical. The number following indicates the greatest dilution below 50%. Therefore it is the definition of the endpoint.
If an area under a dilution is left blank, it indicates that there may have been toxicity at that dilution, the test may not have been worth reading, or no interpretable data is available.
If an area under dilution is marked with a hyphen (-), it indicates that there are no plaques and there is a successful inhibition of herpes (HSV).
EXAMPLES 15-18
In these in vitro tests, the following drugs (medicine) was used:
Drug # 1. = Benzalkonium chloride surfactant in an aqueous solution at a ratio of 1:750. The surfactant in the aqueous solution was filtered before use and diluted in an equal volume of 2X MEM to give a 1:1500 dilution in IX MEM.
Drug # 2 = Echinacea powder (photochemicals) in an aqueous solution. This preparation was extracted by warm infusion in sterile water. The extracted phytochemicals was centrifuged and filtered before use. The filtere'd phytochemicals were diluted in an equal volume of 2X MEM to give the undiluted preparation in IX MEM.
Drug # 3 = Echinacea powder (phytochemicals) were extracted and combined with benzalkonium chloride surfactant by a cold infusion process. The combined preparation was centrifuged and filtered before use and diluted in an equal volume of 2X MEM to give the undiluted preparation in IX MEM.

1. Three 24-compartment plates were inoculated with
fibroblasts. Three different extractions (for comparison) in five
concentrations of the composition were used to screen for
antiviral activity in concentrations of: undiluted, 1:2, 1:4,
1:8, and 1:16 in IX MEM. There were four control compartments on
each plate containing MEM without drug.
2. The growth media was removed from the compartments and
200ul of HSV-1 was added to each compartment of the upper half
of each plate. HSV-1 was diluted 1:5000 (2.0 ul of stock HSV-1
in 10 mL of MEM). The virus titer was 3xl06 per mL. Also, 200ul
of HSV-2 was added to each compartment of the lower half of each
plate. HSV-2 was diluted 1:2,000 (5.0 ul of stock HSV-2 in 10 mL
of MEM). The virus titer was 6xl05 per mL.
3. The plates were incubated at 37°C for two hours. .
* • -k •'
4. The inoculum was removed and one mL of the MEM
containing Drugs #1-3 were added to the four compartments. The
concentration of the drug compared to the MEM is indicated below.
Table 1
(Table Removed)
5. Results: HSV-1, liquid overlay, Drug added immediately
after virus absorption.
Plate 1, Drug #1 contaminated with bacteria! No growth, maybe debris.
Plate 2, Drug #2 contaminated with bacteria! No growth, maybe debris.
Plate 3, Drug #3 The results are indicated in Tables 2 and 3 below.
Table 2 - Drug #3 HSV 1 Test Results
(Table Removed)
Table 3 - Drug #3 HSV 2 Test Results
(Table Removed)

*slight toxicity.
**very small plaques
Comments: Testing with the medicine (Drug #3) provided excellent results. The cells look fine with no contamination. At the lower dilutions, the preparation may be toxic to some of the cells. This preparation was unexpectedly successful in its inhibitory activity.
* •»
EXAMPLES 19-22
Three 24-compartment plates were inoculated with fibroblasts and the following drugs.
Test Drug #1A = Benzalkonium chloride surfactant in an aqueous solution. The benzalkonium chloride surfactant was prepared by making a 1:375 dilution in water (32ul in 12.0 mL of sterile water). This was filtered before use. This was diluted in an equal volume of 2X MEM to give 1:750 dilution in 1XMEM. The dilution was done to maintain the ratio.
Test Drug #2A = Echinacea purpurea powder (phytochemicals} in an aqueous solution. This preparation was a 50 mg/mL solution (300 mg in 6.0 mL of water) of Echinacea purpurea powder in sterile water. The mixture was vortexed and refrigerated for four hours. The Echinacea powder preparation was centrifuged at 3500 rpm for 15 minutes at 10° C and filtered before use and then diluted in an equal volume of 2X MEM to give the undiluted preparation in 1XMEM.
Test Drug #3A = Echinacea purpurea powder(phytochemicals) dissolved in benzalkonium chloride surfactant. This preparation was a 50 mg/mL solution (300 mg in 6.0 mL of benzalkonium chloride, 1:375). The mixture was vortexed and refrigerated for four hours. The phytochemical and surfactant mixture was
centrifuged at 3500 rpm for 15 minutes at 10° C and filtered before use, and then diluted in an equal volume of 2X MEM to give •the undiluted preparation in 1XMEM.
1. Three plates were used to screen the three drug
preparations. The concentrations needed to screen for antiviral
activity were 1:2, 1:4, 1:8, and 1:16 in IX MEM. There were four
control compartments on each plate containing MEM without drug.
2. The growth media was removed from the compartments and
200ul of HSV-1 was added to each compartment of the upper half
of each plate. HSV-1 was diluted 1:5000 (2.0 ul of stock HSV-1
in 10 mL of MEM). The virus titer was 3xl06 per mL.
3. The plates were incubated at 37°C for four hours.
4. The inoculum was removed and one mL of the MEM
containing drugs #1A-3A were added to the four compartments.
Table 4
(Table Removed)
5. Results: HSV-1, liquid overlay, composition added
immediately after virus absorption.
Table 5 - Drug #1A - HSV 1 Test Results
(Table Removed)
Comments: These compartments have a fine precipitate over the cells. Benzalkonium chloride probably precipitates with the protein in the medium.
Table 6 - Drug #2A - HSV 1 Test Results
(Table Removed)
Comments: Although there were some plaques, they were very small.
Table 7 - Drug #3A - HSV 1 Test Results
(Table Removed)
Comments: Although there was some toxicity, this drug was very successful in inhibiting the virus, there did not appear to be any plaques.
EXAMPLES 23 - 27
Four 24-compartment plates were inoculated with fibroblasts.
Test Drug #1B = Benzalkonium chloride surfactant in an
aqueous
diluent. The benzalkonium chloride was prepared by making a 1:1000 dilution in water (lOul in 10.0 mL of sterile water). This was filtered before use and diluted in an equal volume of 2X MEM to give 1:2000 dilution in 1XMEM.(500 ul drug plus 500 ul of 2X MEM) .
Test Drug #2B = Echinacea purpurea powder (phytochemicals) in an aqueous solution. This preparation was a 50 mg/mL solution (250 mg in 5.0 mL of water) of Echinacea purpurea powder in sterile water. The mixture was vortexed and refrigerated for four hours. This Echinacea powdered preparation was centrifuged at 3500 rpm for 15 minutes at 10° C and filtered before use, and diluted in an equal volume of 2X MEM to give the undiluted
preparation in 1XMEM.(500 ul drug plus 500 ul of 2X MEM).
Test Drug #3B = Echinacea purpurea powder (phytochemicals) dissolved in benzalkonium chloride surfactant. This preparation was a 50 mg/mL solution (250 mg in 5.0 mL of- benzalkonium chloride, 1:1000). The mixture was vortexed and refrigerated for four hours. The Echinacea phytochemicals and surfactants were centrifuged at 3500 rpm for 15 minutes at 10° C and filtered before use, and then diluted in an equal volume of 2X MEM to give the preparation in 1XMEM (500 ul drug plus 500 ul of 2X MEM).
Test Drug #4B = Echinacea purpurea powder (phytochemicals) in an aqueous solution (diluent) and then mixed with benzalkonium chloride surfactant at a ratio of 1:1000. This preparation was a 50 mg/mL solution (250 mg in 5.0 mL in 5.0 mL of water) of Echinacea purpurea powder in sterile water. The mixture was vortexed and refrigerated for four hours. The aqueous phytochemicals were centrifuged at 3500 rpm for 15 minutes at 10° C and filtered before use. This .preparation was diluted in an equal volume of benzalkonium chloride at a ratio of 1:1000, to get the Echinacea-benzalkonium chloride mixture. This mixture was diluted with equal volume of 2X MEM to give the 1:4 preparation in 1XMEM (500 ul drug #1 and 250 ul drug #2 plus 500 ul of 2X MEM) .
1. Four plates were used to screen the four drug
preparations. The concentrations needed to screen for antiviral
activity were 1:20, 1:40, 1:80, and 1:160 and 1:320 in IX MEM.
There were four control compartments on each plate containing MEM
without drug.
2. The growth media was removed from the compartments and
200ul of HSV-1 was added to each compartment of the upper two
rows of each plate. HSV-1 was diluted 1:5000(2.0 ul of stock HSV-
1 in 10 mL of MEM) . The virus titer was 3xl06 per mL. Also,
200ul of HSV-2 was added to each compartment of the lower half
of each plate. HSV-2 was diluted 1:2,000 (5.0 ul of stock HSV-2
in 10 mL of MEM). The virus titer was 6xl05 per mL.
3. The plates were incubated at 37°C for four hours.
4. The inoculum was removed and one mL of the MEM
containing drugs # 1-4 was added to the four compartments.
Table 8(Table Removed)

5. Results: HSV-1, liquid overlay, drugs added immediately after virus absorption.
Table 9 - Drug #1B - HSV 1 Test Results
(Table Removed)

Comments: Slightly toxic, test was difficult to read.
HSV-2, liquid overlay, drugs added immediately after virus absorption.
Table 10 - Drug #1B -'HSV 2 Test Results
(Table Removed)

Comments: Test was too toxic to give a good reading.
Table 11 - Drug #2B - HSV 1 Test Results (Table Removed)

Comments: Small plaques.
Table 12 - Drug J»2B - HSV 2 Test Results (Table Removed)

Table 13 - Drug #3B - HSV 1 Test Results
(Table Removed)
Comments: Although there was some toxicity, drug very
successful there did not appear to be any plaques.
Table 14 - Drug #3B - HSV 2 Test Results
(Table Removed)

Comments: A difficult test to get a really good reading. However the drug has successful inhibitory activity.
Table 15 - Drug #4B - HSV 1 Test Results
(Table Removed)

Comments: Too toxic at the higher levels. Nonetheless, there was inhibitory activity at 1:320
Table 16 - Drug #4B - HSV 2 Test Results
(Table Removed)

Comments: Toxicity probably due to the benzalkonium chloride. The drug at the 1:320 dilution showed very strong inhibitory activity.
The in vitro tests of Examples 23-27 used raw materials which were not refined. Nevertheless, the tests demonstrate surprisingly good viral inhibitory activity and a probable
synergy between the constituents.
In the preceding in vitro tests where Drugs #3, 3A and 3B, were Echinacea purpurea phytochemicals extracted and combined with benzalkonium chloride surfactant, the resultant medicine, demonstrated the greater antiviral activity, and most remarkably demonstrated a synergy between the components: Echinacea purpurea and benzalkonium chloride. This can possibly be explained by a shared stability and enhanced reactivity between the two components. The benzalkonium chloride in the synergistic mixture exhibited a lesser degree of toxicity and the synergistic combination (medicine) exhibited a greater degree of antiviral activity, particularly with HSV-2.
SURFACTANTS
While benzalkonium chloride is the preferred surfactant for best results, in some circumstances it may be desirable to use other quanternay ammonium surfactants or other surfactants.
The quaternary ammonium compound can be dicocodimonium chloride, which is also known as dicoco alkyldimethyl, chlorides or dicoco dimethyl ammonium chloride or Di-C8-18-alkyldimethyl, chlorides. This can be used in combination with isopropanol, such as 20-30% isopropanol. The preferred source of quaternary compound comprises: 70-80% quaternary ammonium compound and less than 0.03% methyl chloride, has a specific gravity of about 0.87 at 115 degrees F, a vapor pressure of 33 mm/Hg at 68 degrees F, an initial boiling point of 180 degrees F at 760 mm/Hg, and a volatility of 20-30%, and is produced under the brand name CarSpray 300 by Witco Corporation, Dublin, Ohio, USA. The quaternary compound can provide disinfecting qualities and serves as a fungicide to teat fungus and yeast infections.
Other quaternary ammonium compounds may be useful, such a:.-, produced under the brand name Jet Quat 2C-75 by Jetco Chemicals, Inc. of Corsicana, Texas, USA, or produced under the brand name:; Carspray 400 and Carnauba Spray 200 by Witco Corporation, Dublin, Ohio, USA, or containing 9% denatured ethyl alcohol such as sold under the brand name ETC 2125M by Stephan Company, Northfield,
Illinois, USA, or the following MAQUAT products comprising n-alkyl dimethyl benzyl ammonium chloride produced by Mason Chemical Company, Arlington Heights, Illinois, USA. LC-12S (67% C12, 25% C14, 7% C16, 1% C18), MC 1416 (5% C12, 60% C14, 30% C16, 5% C18), MC1412 (40% C12, 50% C14, 10% C16), SC-18 stearyl paste or flake (5% C16, 95% C18), TC-76 or MQ-2525 (5% C12, 60% C14, 30% C16, and 5% C18) and MC6025-50% (25% C12, 60% C14 and 15% C16). Jet Quat 2C-75 comprises: 50-75% dicoco dimethyl quaternary ammonium chloride, 20-50% isopropyl alcohol, has a specific gravity of 0.88 and a boiling point of 180 degrees F. CarSpray 400 comprises: 55-65% quaternary ammonium compounds, 20-30% amines, C14-18 & C16-18 unsaturated, alkyl, ethoxylated, 10-20% isopropanol, and less than 0.03% methyl chloride, and has a specific gravity of approximate 0.88 at 75 degrees, F, a vapor pressure of 33 mm/Hg at 68 degrees F, an initial boiling point of 180 degrees F at 760 mm/Hg, and a volatility of 10-20%. Carnauba Spray 200 comprises: 50-60% quaternary ammonium compounds, 10-20% isopropanol, 15-25% water, 1-10% alkoylated carnauba wax, and less than 0.03% methyl chloride, and has a specific gravity of about 0.90 at 80 degrees F, a vapor pressure of 33 mm/Hg at 68 degrees F, an initial boiling point of 180 degrees F at 760 mm/Hg, and a volatility of 20-40%.
Nonionic surfactants are surface-active compounds which do not ionize in water solution. Often times these possess hydrophilic characteristics by virtue of the presence therein or an oxygenated chain (e.g., a poly-oxyethylene chain), the lyophilic portion of the molecule being derived from fatty acids, phenols, alcohols, amides or amines. Exemplary compounds are the poly-(ethylene oxide) condensates of alkyl phenols, e.g. the condensation product formed from one mole of nonyl phenol and ten moles of ethylene oxide, and the condensation products of aliphatic alcohols and ethylene oxide, e.g. the condensation product formed from 1 mole of tridecanol and 12 moles of ethylene oxide.
The nonionic surfactants can comprise phenol ethoxylates comprising a condensate product of ethylene oxide and an alkyl phenol or an aliphatic alcohol. The nonionic surfactants
preferably comprise nonophenol ethoxylate such as T-DET, and/or octaphenol ethoxylate. The nonionic surfactants are reaction products of ethylene oxide and nonolphenol and/or octalphenol. The ratio of the phenol to the ethylene oxide can range from 2:20 to 4:16 and preferably is about 8:12.
Nonionic synthetic surfactants can comprise nonionic detergents. Nonionic synthetic surfactants can also be formed by condensing ethylene oxide with a hydrophobic base formed by the condensation of propylene oxide with propylene glycol. The hydrophobic portion of the molecule which, of course, exhibits water insolubility has a molecular weight of from about 1200 to 2500. The addition of polyoxyethylene radicals to this hydrophobic portion tends to increase the water solubility of the molecule as a whole and the liquid character of the product can be retained up to the point where polyoxyethylene content is about 50% of the total weight of the condensation product.
Other nonionic synthetic surfactants can include: the polyethylene oxide condensates of alkylphenols, e.g. the condensation products of alkylphenols or dialkylphenols wherein the alkyl group contains from about 6 to 12 carbon atoms in either a straight chain or branched chain configuration, with ethylene oxide. The ethylene oxide can be present in amounts equal to 8 to 25 moles of ethylene oxide per mole of alkylphenol. The alkyl substituent in such compounds can be derived from polymerized propylene, diisobutylene, n-octene, or n-nonene.
Nonionic surfactants can also be produced from the condensation of ethylene oxide with the reaction product of propylene oxide and ethylenediamine, e.g. compounds containing from about 40% to about 80% polyoxyethylene by weight and having a molecular weight of from about 5,000 to about 11,000 resulting from the reaction of ethylene oxide groups with a hydrophobic base comprising the reaction product of ethylenediamine and excess propylene oxide; the base having a molecular weight on the order of 2,500 to 3,000.
Other nonionic surfactants include the condensation product of aliphatic alcohols having from 8 to 18 carbon atoms, in either-straight chain or branched chain configuration, with ethylene oxide, e.g. a coconut alcohol ethylene oxide condensation having from 10 to 30 moles of ethylene oxide per mole of coconut alcohol, and the coconut alcohol fraction having from 10 to 14carbon atoms.
Further nonionic surfactants include long chain tertiary ^amine oxides corresponding to the following general formula:
RiR3R2N lo
wherein Rl is an alkyl radical of from about 8 to 18 carbon atoms, and R2 and Rj are each methyl or ethyl radicals. The arrow in the formula is a conventional representation of a semi-polar bond. Examples of amine oxides suitable for use include: dimethyldodecylamine oxide, dimethyloctylamine oxide, dimethyldecylamine oxide, dimethyltetradecylamine oxide, and
dimethylhexadecylamine oxide.
Other nonionic surfactants can include: long chain tertiary
phosphine oxides corresponding to the following general formula
RR'R"P|0
wherein R is an alkyl, alkenyl or monohydroxyalkyl radical ranging from 10 to 18 carbon atoms in chain length and R1 and R" are each alkyl or monohydroxyalkyl groups containing from 1 to 3 carbon atoms. The arrow in the formula is a conventional representation of a semi-polar bond. Examples of suitable phosphine oxides are: dimethyldodecylphosphine oxide, dimethyltetradecylphosphine oxide, ethylmethyltetradecylphosphine oxide, cetyldimethylphosphine oxide, dimethylstearylphosphine oxide, cetylethylpropylphosphine oxide, diethyldodecylphosphine oxide, diethyltetradecylphosphine oxide, dipropyldodecylphosphine oxide, bis-(2-hydroxymethyl) dodecylphosphine oxide, bis-(2-hydroxyethyl)dodecylphosphine oxide, (2-hydroxy propyl)methyltetradecylphosphine oxide, dimethyloleylphosphine oxide, and dimethyl-(2-hydroxydodecyl)phosphine oxide.
In some circumstances it may be useful to use other surfactants such as: another cationic surfactant, an ampholytic surfactant or a zwitterionic surfactant.
The cationic surfactants can include cationic detergents.
The cationic surfactants comprise compounds which ionize in an
aqueous medium to give cations containing the lyophilic group.
Typical of these compounds are the quaternary ammonium salty
which contain an alkyl group of about 12 to about 18 carbon
atoms, such as lauryl benzyl dimethyl ammonium chloride.
Ampholytic surfactants are compounds having both anionic
and cationic groups in the same molecule. Exemplary of such compounds are derivatives of aliphatic amines which contain a -long chain of about 8 to about 18 carbon atoms and an anionic water solubilizing group, e.g., carboxysulfo, sulfo or sulfato.
Examples of ampholytic detergents are: sodium-3-dodecylaminopropane sulfonate, sodium-N-methyl taurate, and related substances such as higher alkyl : disubstituted amino acids, betaines, thetines, sulfated long chain olefinic amines, and sulfated imidazoline derivatives.
Zwitterionic surfactants can include synthetic detergents.
Zwitterionic surfactants are generally derivatives of aliphatic quaternary ammonium compounds in which the aliphatic radical can be a straight chain or branched and wherein one of the aliphatic substituents contains from about 8 to 18 carbon atoms and one contains an anionic water solubilizing group, e.g., carboxy, sulfo, or sulfato. Examples of compounds falling within this definition are: 3-(N,N-dimethyl-N-hexadecyl ammonio)-propane-1-sulfonate and 3-(N,N-dimethyl-N-hexadecyl ammonio)-2-hydroxy propane-1-sulfonate.
TREATMENT
The preferred medical treatment comprises a method for u^se in treating herpes virus or other infectious diseases by
*r
resolving the physical symptoms of an infectious outbreak of herpes simplex virus 1 or 2 (HSV 1 or HSV 2) or other infectious microbial diseases within 10-30 hours. This is accomplished by topically applying the above described preferred antimicrobial compound (medicine) on the infected area of the herpes simplex virus or other infectious microbial disease, and maintaining the antimicrobial compound on the infected area for 10-30 hours. The antimicrobial compound (medicine) can be applied in the manner previously described and most preferably coats the infected area. Desirably, the infected area is rinsed (washed) and dried to remove any soap or residue on the infected area before the antimicrobial compound (medicine) is applied. Preferably, vesicular eruption of herpes virus are resolved in 19-24 hours and herpes lesions are healed by maintaining the above described
most preferred medicine on the infection for 19-24 hour.
The many advantages and uses of the herbaceous botanical products and method of manufacturing the herbaceous botanical products, include but are not limited to:
1. Superior results in ending the pain of herpes simplex viral
infections and other microbial infections.
2. Outstanding performance in rapidly resolving outbreaks of
herpes simplex virus and other microbial diseases.
3. Potentially saves lives of neonates and animals.
4. Reduces risk of blindness in newborns.
5. Reduces worldwide economic loss from herpes and other
microbial diseases.
6. Resolves the serious emotional and mental anguish of herpes
sufferers.
7. Readily available materials (ingredients).
8. Economical.
9. Safe.
10. Easy to use.
11. Dependable.
12. Effective.
Although embodiments of the invention and examples have been shown and described, it is to be understood that various modifications and substitutions, as well as other uses, rearrangements of parts, components, and process steps, methods of manufacture, and treatments, can be made by those skilled in the art without departing from the novel spirit and scope of this invention.

We claim:
1. A process for preparing a synergistic herbal pharmaceutical
composition comprising:
blending from 2% to 90% by wt. of an extract from the
herb of the genus Echniacea
from 0.005% to 0.8% by wt. surtefctant of the kind as herein described and the balance, if any, adding a diluent and a carrier.
2. A process as claimed in claim 1 wherein the said surfactant is
benzalkonium halide.
3. A process as claimed in claim 1 wherein the said surfactant is
selected from nonionic surfactant, quanternary ammonium
surfactants, nonionic synthetic surfactants, cationic surfactants,
ampholytic surfactant or zwitterionic surfactant.
4. A process as claimed in claim 2 wherein the proportions in which
the ingredients are blended are
from 40% to 60% by wt. of an extract from the herb of the genus Echniacea
from 0.02% to 0.30% by wt. benzalkonium halide and form 20% to 60% by wt. water.
5. A process as claimed in any one of the preceding claims,
characterized in that said benzalkonium halide consists of
benzalkonium chloride.
6. A process as claimed in any one of the preceding claims wherein
the extract from the herb of the genus Echniacea is obtained from
at least one of the following:
Echinacea purpurea, Echinacea angustifolia, Echinacea pallidae, Echinacea vegetalis or Echinacea atribactilus.
1. A process as claimed in claim 6 wherein the extract is obtained from Echinacea purpurea.
8. A process as claimed in any one of the preceding claims wherein
the extract from the herb of the genus Echniacea comprises
phytoproducts selected from the group consisting of: echinacen;
echinacen B; echinaceine; echinacoside; caffeic acid pester;
echinolone; enzymes; glucuronic acid, inulini inuloid;
pentadecadiene; polyacelylene compounds polysaccharides,
arabinogalactan; rhamnose; tannins; PSI (a 4-0-
methylglucoronoarabinoxylan, Mr 35 Kd); PSII ( an acid
rhamnoarbinogalactan, Mr 450 Kd), cynarin; 1, 5-di-O-
caffeoylquinic acid; chicoric acid, 2, 3-0-di-caffeoyltartaric acid,
borneol; bornyl acetate, pentadeca -8 (z) - en-zone; germacrene
D; caryophyllene; caryophyllene epoxide; anthocyanin,
pyrrolizidine alkaloid, lipophilic amide; isobutylamide;
plyacetaylene; anthocyanin; 3-0-B-D-glucopyranoside; 3-0-(6-0-
mabonyle)-B-D-glucopyranoside; tussilagine; isotussilagine;
isomeric dodeca isobutylamide; tetraenoic acid or carophylenese.
9. A process as claimed in any one of the preceding claims extract
from the herb of the genus Echniacea comprises phytoproducts
comprising by weight based upon the total weight of the product:
from 0.3% to 9& echinacoside;
from 0.1% to 7% by wt. PSI (4-0-methylglucoronoararabinoxylan, Mr 35 Kd ) and PSII (acid rhamnoarabinogalactan, Mr 450 Kd), from 0.1% to 10% by wt. cynarin (1, 5-di-o-caffeoylquinic acid) and chioric acid (2, 3-0-di-caffeoyltartaric acid) and derivatives thereof,
from 0.2% to 4% by wt. echinolone,
from 0.2% to 6% by wt. echinacin B,
from 0.1% to 6% by wt. echniaceine,
from 2% to 7% by wt. anthonocyanins comprising
cynanidin 3-0-B-d-glucopyranoside and 3-0-(6-0-malonyl)-
B-D-glucopyranoside;
from 0.01% to 0.06% by wt. pyrrolizidine alkaloids
comprising tussilagine and isotussilaine;
from 0.003% to 0.009% by wt. isomeric dodeca
isobutyalamides and tetraoenoic acid and
from p.01% to 2% caryophylenes.
10. A process for preparing a synergistic herbal pharmaceutical composition substantially as herein desqribed with reference to the foregoing examples.

Documents:

502-del-2001-abstract.pdf

502-del-2001-claims.pdf

502-del-2001-complete specification (granted).pdf

502-del-2001-correspondence-others.pdf

502-del-2001-correspondence-po.pdf

502-del-2001-description (complete).pdf

502-del-2001-form-1.pdf

502-del-2001-form-2.pdf

502-del-2001-form-3.pdf

502-del-2001-pa.pdf

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Patent Number

199484

Indian Patent Application Number

502/DEL/2001

PG Journal Number

37/2008

Publication Date

12-Sep-2008

Grant Date

05-Jan-2007

Date of Filing

17-Apr-2001

Name of Patentee

Squires Meryl J.

Applicant Address

2 Goose Lake Drive, Barringtonm, Illinois 60010,USA.

Inventors:

#	Inventor's Name	Inventor's Address
1	Squires Meryl J.	2 Goose Lake Drive, Barringtonm, Illinois 60010,USA.

PCT International Classification Number

A61K 35/78

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA