Title of Invention

A METHOD OF MAKING A COMPOSITION FOR THE TREATMENT OF HEMORRHOIDS AND HEMORRHOIDAL SYMPTOMS

Abstract

A method of making a composition for the treatment of hemorrhoids and hemorrhoidal symptoms comprising making water soluble extract of sansevieria leaf consisting of washing sansevieria leaves thoroughly with water to remove dust and dirt, chopping, the leaves into pieces and blending the same in a blender at 700 to 3000 rpm for 3 to 10 minutes with 3 to 5 parts of water for every part of leaf substance until a homogenous slurry is obtained, and filtering the slurry through a 50 micron filter media to obtain water soluble extract of sansevieria leaf in solution form; homogenously mixing the said sansevieria extract in the flour of cicer arietnum in a ratio of 1 to 10 parts of the said extract to 100 parts of the flour; and 1 to 10 parts of salt, rolling and frying/baking the flour to make the composition in the form of pancakes.

Full Text

THE PATENTS ACT, 1970 PROVISIONAL SECTION-10 A METHOD OF MAKING A COMPOSITION FOR THE TREATMENT OF HEMORRHOIDS AND HEMORRHOIDAL SYMPTOMS RAJEEVAGNIHOTRI of 71, Shree Nagar Ex., Indore 452 001, Madhya Pradesh, India, an Indian National THE FOLLOWING SPECIFICATION DESCRIBES THE NATURE OF THIS INVENTION:- This invention relates to a novel method of treatment of hemorrhoids and other ailments of the ano-rectal region, a novel composition for treatment and a novel method of making such a composition having an active healing agent. In particular, this invention relates to a composition for the relief and treatment of hemorrhoids and hemorrhoidal symptoms. Still particularly, the present invention relates to the treatment of anorectal diseases including hemorrhoids by the application of novel pharmaceutical compositions containing a unique agent possessing wound-healing and antimicrobial properties. The expression ano-rectal region as used herein, is meant the lower colon leading to the rectum and opening into the anal canal, which form the lower portion of the alimentary tract in conjunction with the perineum in close proximity to the anal opening. The ano-rectal region especially means the area in close proximity to the external and internal anal sphincter muscles, the voluntary external anal sphincter and skin around the anus innervated by the inferior rectal nerve a branch of the pudendal nerve. Hie internal* anal* sphincter is a thickening of the inner circular muscular coat of the canal. There is an internal hemorrhoidal plexus of veins located in thesubmucosal space above the valves of morgagini. The anal canal separates this spa.ce from the external hemorrhoidal venous plexus but the two spaces communicate under the anal canal, the submucosa of which is attached to underlying tissue to form the interhemorrhoidal depression. The folds of the submucosa contain twigs of the superior rectal artery and vein. Varicosity of these veins causes enlargement and saccular dilations of the internal rectal hemorrhoidal plexus with the associated increase in the supporting tissue mass and the resultant venous spelling is called an internal hemorrhoid. Varicosity can also occur of the veins draining the end of the anal canal enlarging and thrombosing the external hemorrhoidal plexus, the resultant bluish mass is called an external hemorrhoid. Most ailments of the anorectal region of the human body are characterized by inflammation, itching, ulcerations and/or lesions with associated pain. The most common of the diseases treated by the medication disclosed herein is hemorrhoids or piles. Hemorrhoids are therefore, irregular venous abnormalities occurring in the ano-rectal region causing bleeding, itching, soreness and other discomfort. This invention relates both to external hemorrhoids and interna? hemorrhoids. Both types of hemorrhoids are common and are associated with increased hydrostatic pressure in the portal venous system. The various factors responsible for causing of hemorrhoids are: [i] froor support to veins from the surrounding loose connective tissue so that veins are less capable of resisting increased blood pressure. Increase in the hydrostatic pressure occurs chiefly during pregnancy, straining at stool or cirrhosis, [ii] absence of valves in the superior rectal and the portal veins, [iii] compression of the veins at the sites where they pierce the muscular coat of the rectum, [iv] direct transmission of the increased portal pressure at the portal-systemic communications. Internal hemorrhoids, because they are above the pectinate line, do not generally present with pain unless the situation is complicated with thrombosis, infection or erosion of the overlying mucosal surface. Typical complaints are bright red blood in the feces and vague anal discomfort. This discomfort is increased when the hemorrhoid enlarges and prolapses through the anus, accompanied by edema and sphincteric spasm. Prolapsed hemorrhoids may become infected or thrombosed. External hemorrhoids lie under the skin and are usually painful. These result in a tender blue swelling at the anal verge due to thrombosis of a vein in the external plexus. Sphincteric spasm usually occurs. The trauma of defecation may cause the overlying mucosal membrane to bleed profusely. Defecation in fact, causes several major problems in healing in the anorectal region. During defecation, the fecal mass tends to dilate, tear and traumatize the swollen and inflamed tissue. Further muscular strain particular if there is constipation, during bowel evacuation to overcome the swollen tissue around the anal sphincter muscles, causes herniation of the anal walls and further swelling. The fecal mass contains numerous infectious organisms which penetrate damaged tissue and hamper healing. Left untreated, hemorrhoids often becomes worse and sometimes requires surgery for removal and/or repair or amputation of a prolapsed anus. Hemorrhoids and other ano-rectal diseases cause breakdown of epithelium, dermis, and other subcutaneous tissues which may result in a variety of wouncls including fissures, cracks, abscesses. But even when tissues still remain intact, as it is sometimes the case for certain types of hemorrhoids, they are considered as wounds because inflammation occurs. Hemorrhoids are treated with conservative therapy such as sitz baths, moist heat, suppositories stool softeners and bed rest. Prolapsed hemorrhoids are generally treated surgically or by banding or using sclerosing solutions. 4 External hemorrhoids are treated by incision, extraction of clot and compression of the incised area. Various compositions have been hitherto tried both for symptomatic and sustained relief. Compositions for the relief and treatment of hemorrhoids have been subject matter of several patents, for example, the following patents (all of which are incorporated into this disclosure by this reference) Some of them are based on anesthetic (U.S. Pat. No. 4,118,480) or vasoconstrictive ( 4,145,441) active agents or where the active agents are used only to give temporary symptomatic relief or are used for external application (U.S. Pat. Nos. 3,950,540; 3,950,541). Other patents include the following: U.S. Pat. No. 3,608,074 ("Pharmaceutical Compositions and Method of Making the Same"—Yves Rocher) U.S. Pat. No. 3,935,310 ("Remedy for Treatment of Hemorrhoids"-John D. Homan) U.S. Pat. No. 4,192,866 ("Anorectal Medication"-Ralph Anderson) U.S. Pat. No. 4,261,981 ("Medical Compound Produced from Ragweeds- Sam Humphrey) U.S. Pat. No. 4,383,986 ("Hemorrhoidal Compositions"-Darius D. Dubash, et al.) Further, several .U.S. Patents for example U.S. Pat. Nos. 4,169,143; 4,192,866; 4,508,728 disclose compositions containing healing agents for treatment of hemorrhoids and other anorectal diseases. U.S. Pat. No. 4,518,583 discloses the use of compositions containing antimicrobial agents to treat anorectal diseases including hemorrhoids. In the prior art hemorrhoid treatments, compositions have been developed generally to relieve either the itching (pruritus ani) or the inflammation with limited success. The efficacy of the prior art treatments in relieving or curing a variety of symptoms is uncertain, and many of the treatments are associated with side effects and allergic reactions. None of the treatments in the prior art have been shown to be completely effective in relieving these symptoms and provide long-lasting symptomatic relief by promoting tissue repair, reducing inflammation and encouraging wound healing. Further, the presence of microorganisms such as fungi, bacteria, yeast and others delay healing and retard tissue repair. In some cases the treatments themselves contribute to further problems such as causing allergies or additional tissue irritation. The principal object of this invention is to provide a composition for use in the anorectal area; to provide such a composition with a unique water- 6 soluble active ingredient which can be used orally or topically and therefore uniformly distributed in the effected region and have long-lasting effects. Another object of this invention is to provide a composition which enhances healing of injured tissue and fascia. Still another object of this invention is to provide a composition which reduces inflammation; to provide such compositions which soothe itching and burning in the anal region. Yet another object of this invention is to provide a composition which reduces irritation and swelling of diseased tissue. One more object of the invention is to provide a composition which provides relief from pain associated with anorectal afflictions including hemorrhoids. Another object of this invention is to provide a compositions which relieves discomfort to a patient suffering from hemorrhoids. Still another object of this invention is to provide a composition which inhibits growth and development of harmful microorganisms and at the same time inhibits activity of toxins produced by microorganisms in the ano¬rectal region. Anotho.- object is to provide a composition useful for treatment of wounds, L-sions other than hemorrhoids (fissures, cracks, fistulas, abscesses) in the aii-o/o- :.al region without unfavorable side effects. In accordance with another set of objects of this invention there is provided a method of making a composition suitable for treatment of ailments of the ano-rectal region, particularly hemorrhoids. In furtherance of the objects of this invention, it has been found that water soluble or suspension extract of the plant known generally as sanseveiria have therapeutic effects in the treatment of conditions of the ano-rectal region. Note on sansevieria Botanical name: sansevieria zeylandica/ sansevieria trifasciata Common name: good luck plant, mother-in-law's tongue, snake plant. Family: agavaceae (dracaenaceae). These plants belong to the Agave-family (Agavaceae), although several botanists place Sansevieria together with Draceana and Cordyline in the Lily-family (Liliaceae), while putting Agave-species in the Amaryllidaceae. The Swedish naturalist C.P. Thumberg got the plant from its discoverer, Vincenzo Petanga from Napels, who named it Sansevieria, after Raimondo di Sangro, prince of Sanseviero, who was a military man and an inventor. The 60 species of Sansevieria are found in tropical and subtropical regions in Africa and Asia and particularly in India, Indonesia and Madagascar. A couple of species are common as house plants. Sansevierias flowers are white on an unbranched spike, vaguely reminiscent of a hyacinth. They are often scented, particularly in the evening. They are propagated by seeds, suckers or leaf cuttings. Leaf cuttings of variegated forms generally revert to the non variegated form. 4 inch segments of leaves (10 cm) are used for leaf 8 cutting. Care has to be taken to keep track of which side of the cutting is the top and which is the bottom. The leaf cutting is inserted 1 to 1.5 inches (3-4 cm) in rooting medium. Each cutting produces several plantlets. It is generally defined as a herbaceous tropical perennial consisting of erect, strap - like leaves up to 5' tall. The foliage is stiff, succulent, mottled, blotched or lined; and in many shapes and sizes. There are several varieties of the good luck plant such as S. trifasciata laurentii "compacta goldeana", S. trifasciata "Hahnii", S. trifasciata Golden Hahnii and S. arborescens. Sansevieria aethiopica, Sansevieria bacularis, Sansevieria canaliculata, Sansevieria cylindrica var. patula, Sansevieria dawei, Sansevieria fischeri (singularis), Sansevieria gracilis, Sansevieria hyacinthioides "Mason Congo", Sansevieria metallica (sp. Marnier Lapostalle), Sansevieria parva ,(Kenya hyacinth), Sansevieria pearsonii, Sansevieria philipsiae, Sansevieria pinguicula, Sansevieria thyrsiflora, Sansevieria trifasciata "Moon shine", Sansevieria sp.; Sansevieria scabrifolia, Sansevieria angustiflora (Bowstring Hemp); Sansevieria grandis var. zuluensis ; Sansevieria guineensis ; Sansevieria kirkii ssp. pulchra (Star Sansevieria); Sansevieria spicata ; Sansevieria suffruticosa; Sansevieria thyrsiflora; Sansevieria trifasciata (Snake Plant, Mother-in-law's tongue) The snake plant is often mottled dark green and cream with small white fragrant flowers. It produces a berry as the fruit. The attraction of Sansevieria lies in the subtle design on the leaves, consisting of vague horizontal bands and stripes, and the differing color of the edge of the leaves. Care for Sansevieria is very simple; give them light (even sun) and 9 warmth, and they will thrive. Water sparsely, and let the soil dry out between two waterings. Nitrogen-rich nutrient solutions must be avoided, as this will result in weedy growth. Instead, to obtain clear patterns in the leaves, cactus-nutrients are used. It is important not to provide the plants with large pots, as this will result in huge and unmanageable plants. Generally, sansevierias are desert-plants, and can tolerate drought and dry air, thus making them very suitable for the office and public buildings. Tolerant of salt and saline soils. Can withstand 28° F. for very brief periods. However, they cannot stand long periods of cold. Most species have thick crawling rhizomes, although some develop stems. The mostly long leaves are stiff and juicy, and serve as a water-stock for periods of drought. Some species are cultured for their hemp-like fibers. The white or greenish flowers appear on long stalks in bunches, and sometimes are fragrant. The reported medicinial use has been in Indian and in "Surinames traditional medicine", in which the leaves are used to treat shingles (herpes zoster). In traditional Indian medicine the root is prescribed in the form of an electuary in consumptive complaints and chronic cough. Juice of the tender shoots of the plants is administered to children to clear their throats of viscid phlegm. According to this invention there is envisaged a water extract of ground Sansevieria leaf substance. The water extract of sansevieria leaf is prepare*' by obtaining leaves of the sansevieria plant above the root, washing the leaves thoroughly with water to remove dust and dirt, chopping, the leaves into pieces and blending the same in a blender at 700 to 3000 rpm with 3 to 5 parts of water for every part of leaf substance. Blending is continued for at least 3 minutes until a homogenous slurry is obtained. The slurry is filtered through 50 micron filter media, typically filter cloth or filter paper. A dark green solution is obtained which contains the water extract of sansevieria leaves. The solution is extremely bitter in taste and not edible as such. In accordance with a preferred embodiment of this invention, there is proposed a water solution containing 10 to 100 parts by mass of water soluble extract of ground Sansevieria leaf substance, in 1000 parts by mass of water. The sansevieria extract is obtained in dry powder form by evaporating the solution or by freeze drying. It has been discovered by the inventor that this substance has remarkable effects on hemorrhoids and hemorrhoidal symptoms and its use provides treatment and relief. In accordance with one aspect of this invention the treatment of hemorrhoids and hemorrhoidal symptoms is effected by making the substance edible and is eaten to effect said treatment. This involves providing an edible composition which includes the substance and an edible carrier. In accordance with a preferred embodiment of this invention, the edible carrier is cooked flour of the dried seed of cicer arietnum [Bengal gram] and salt. Typically, a water based solution is prepared which is intimately mixed with the flour of the dried seed of cicer arietnum [Bengal gram] and salt to form a dough and cooked to form unleavened pancake. A preferred composition is as follows: the content of water soluble extract of ground Sansevieria leaf substance ranges from 1 to 10 parts by mass per 100 parts by mass of the flour of the dried seed of cicer arietnum [Bengal gram] and from 1 to 3 parts by mass of salt. Typically, the flour is cooked in edible oil selected from a group containing, ground nut oil, olive oil, sunflower oil, sesame seed oil, safflower seed oil, palmolein, coconut oil, mustard seed oil, soya bean oil, milk butter oil or hydrogenated vegetable oil shortening. Cooking may be effected by frying or baking. The mixture of cooked flour of the dried seed of cicer arietnum [Bengal gram] and salt mixed together and rolled to form pills. Preferably, non iodized sea salt is used in the composition. In accordance with another aspect of this invention, treatment of hemorrhoids and hemorrhoidal symptoms is effected by applying said composition to an external hemorrhoidal area. To achieve this aspect of the invention the water extract of ground sansevieria leaf is dissolved or dispersed in an appropriate carrier to form salves, suppositories, ointments, foams, sprays and/or medicated pads. There is further provided in accordance with this invention, a salve for the treatment of hemorrhoids and hemorrhoidal symptoms containing water soluble extract of ground sansevieria leaf substance intimately mixed in a carrier selected from the group containing the following carriers: oil, honey, bee's wax, cocoa butter, glycerin, petrolatum and lanolin to aid in applying the salve on the effected area or a suppository containing the substance blended in a carrier selected from the group contammg the following earners: bee's wax, cocoa butter and gelatin to aid in the insertion of the suppository in the anal canal on the effected area or a medicated pad impregnated with the substance or a spray comprising the substance in a propellant. It has been found that the composition in accordance with this invention is more effective than the foregoing treatments for managing ano-rectal afflictions including hemorrhoids and at the same time providing this treatment without some of the undesirable side effects exhibited by some of the other treatments. The advantages of using sansevieria leaf extract will be more apparent in the description of the invention which follows. Trials: [1] 11 patients having symptoms of hemorrhoids with pain and bleeding were administered 2 pancakes early in the morning on an empty stomach containing sansevieria leaf extract in cooked flour of cicer arietnum and salt. Cooking was effected by frying the pancakes in butter oil. All eleven patients were relieved of their symptoms in 7 to 15 days. [2] 7 patients having symptoms of external piles with acute pain were administered a salve containing sansevieria leaf extract in a groundnut oil base. Pain subsided in 1 to 2 days and swelling was significantly reduced in one week. The piles did not reappear after discontinuing treatment after one week. [3] 5 patients exhibiting symptoms of external piles with acute pain were administered an ointment containing sansevieria leaf extract in a bees wax base. Pain subsided in 1 to 2 days and swelling was significantly reduced in one week. The piles did not reappear after discontinuing treatment after one week. [4] exhibiting symptoms of internal piles with acute pain were administered a suppository containing sansevieria leaf extract in a cocoa butter base. Pain subsided in 1 to 2 days and swelling was significantly reduced in one week. The piles did not reappear after discontinuing treatment after one week. [5] 1 patient exhibiting symptoms of internal piles with acute pain were administered a medicated pad containing sansevieria leaf extract I Claim: 1] A method of making a composition for the treatment of hemorrhoids and hemorrhoidal symptoms comprising making water soluble extract of sansevieria leaf consisting of washing sansevieria leaves thoroughly with water to remove dust and dirt, chopping, the leaves into pieces and blending the same in a blender at 700 to 3000 rpm for 3 to 10 minutes with 3 to 5 parts of water for every part of leaf substance until a homogenous slurry is obtained, and filtering the slurry through a 50 micron filter media to obtain water soluble extract of sansevieria leaf in solution form; homogenously mixing the said sansevieria extract in the flour of cicer arietnum in a ratio of 1 to 10 parts of the said extract to 100 parts of the flour; and 1 to 10 parts of salt, rolling and frying/baking the flour to make the composition in the form of pancakes. 2] A method of making a composition for the treatment of hemorrhoids and hemorrhoidal symptoms substantially as described herein. 3] An edible composition for the treatment of hemorrhoids and hemorrhoidal symptoms which comprises a water soluble extract of ground Sansevieria leaves cooked flour of the dried seed of cicer arietnum [Bengal gram] and salt, wherein the content of water soluble extract of ground Sansevieria leaf substance ranges from 1 to 10 parts by mass per 100 parts by mass of the flour of the dried seed of cicer arietnum [Bengal gram] and from 1 to 3 parts by mass of salt. 4] An edible composition for the treatment of hemorrhoids and hemorrhoidal symptoms as claimed in claim 3 wherein the flour is cooked in edible oil selected from a group containing, ground nut oil, olive oil, sunflower oil, sesame seed oil, safflower seed oil, palmolein, coconut oil, mustard seed oil, soya bean oil, milk butter oil or hydrogenated vegetale oil shortening. 5] An edible composition for the treatment of hemorrhoids and hemorrhoidal symptoms as claimed in claim 3 wherein the flour is cooked by frying. 6] An edible composition for the treatment of hemoirhoids and hemorrhoidal symptoms as claimed in claim 3 wherein the flour is cooked by baking. Dated this 27th day of December, 2002 Mohan Dewan OfR.K. Dewan&Co Applicant's patent attorney

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