Title of Invention

A PROCESS FOR THE PREPARATION OF HERBAL MEDICINE AND PRODUCT THEREOF

Abstract

This invention relates to the process for the preparation of a herbal medicine from the plant Centella Asiatica which can be used for the treatment of Kidney, Gallstone, Cancer, Asthma and liver diseases. This herbal preparation was also successfully used for the treatment of diabetes and some viral diseases. This herbal preparation was carried out by soaking the whole plant material of Centella Asiatica in the mixture of water and alcohol in a suitable proportion and some unique processes were applied resulting in the formation of a powdered extract which was used in different manner to combat the aforesaid diseases.

Full Text

2 This invention relates to the process for the preparation of a herbal medicine from the plant Centella asiatica which can be used for the treatment of asthma and liver diseases. This herbal preparation was also successfully used for the treatment of diabetes and some viral diseases. Discussion of the related art A Chinese Patent application CN1439376 discloses a Chinese medicine "asiaticoside", an active principle isolated from Centella asiatica for preventing and treating the fibrosis of lung and liver. According to US patent US6417349A water-soluble extract of asiaticoside and madecassoside from Centella asiatica and an isolating method thereof In the isolating method an aqueous alcohol containing Centella asiatica is subjected to cold-precipitation to obtain an extract. The extract in the aqueous alcohol is treated with a halogenide solvent for layer separation, and then the aqueous layer is extracted with a higher alcohol. The extract in the alcohol layer is washed first with sodium hydroxide and then with water. After being concentrated, the extract is crystallized with ethyl acetate to obtain crystals and the crystals are washed. A method for treating liver cells in a mammal includes administering to a mammal an effective amount of the extract from Centella asiatica containing asiaticoside and madecassoside. An International Patent application WO02096447 relates to the use of a pharmaceutical preparation for producing a medicament used for treating allergic skin diseases, atopic eczema, skin diseases caused by fungi, urticaria, neurodermatitis, psoriasis, psora, skin eczemas, pruritus of the skin, inflammatory skin diseases and/or viral diseases, including chickenpox, varicellas, herpes and herpes zoster. The inventive pharmaceutical preparation comprises natural and/or synthetic active ingredient(s) extracted from the plants Centella asiatica, Mahonia aquifolium, Viola tricolor and/or from plant parts thereof. A novel herbal formulation used to improve the memory and in treatement of amnesia as a brain tonic. This formulation is described in an International Patent application 3 WO2005065698 which comprises of oleaginous oil of Sesamum indicum and the alcoholic extract of Centella asiatica. Conventionally used as emulsion or as a soft gelatin capsule for oral dosage forms. Sesamum indicum used in paralysis, aphrodisiac and dysmenorrhoea. The plant of Centella asiatica is considered as a useful alternative and tonic in diseases of the skin, nerves and blood. Production of an extract (A) of Centella asiatica, containing a mixture of madecassoside (I) and terminoloside (II), is disclosed in a French Patent application FR2848117 which involves: (a) extracting above-ground plant parts with alcoholic solvent; (b) passing the extract through anionic resin; (c) selectively defatting the eluate; (d) concentrating the aqueous alcoholic phase to an aqueous phase, then filtering; (e) passing the aqueous phase through cationic resin then anionic resin; (f) stabilizing and (g) chromatographing. Production of an extract (A) of Centella asiatica, containing a mixture of madecassoside (I) and terminoloside (II), involves: (a) extracting above-ground plant parts with alcoholic solvent; (b) passing the extract through anionic resin; (c) selectively defatting the eluate by liquid-liquid extraction; (d) concentrating the aqueous alcoholic phase to an aqueous phase, then filtering; (e) passing the aqueous phase through cationic resin then anionic resin; (f) stabilizing by addition of alcohol; (g) selectively chromatographing, and (h) recovering the (I)/(II) mixture. An Independent claim is included for the extracts (A) obtained by the process, containing more than 95 wt. % of the (I)/(II) mixture and preferably having an overall (I) content of 30-70%. According to the another application filed at Newzeland NZ515900 an aqueous formulation for topical application includes emu oil, powdered extract of Centella asiatica, organic acids and physiologically acceptable carriers, characterized in that he formulation has a synergistic wound healing effect by reducing scar tissue, reducing swelling and by preventing microbial infection. The use of the formulation in the manufacture of a medicament for the treatment of a wound, a method of treating non-human animals and a method of producing the formulation as a cream are described. US patent 6,756,065 describes a preparation based on plant extracts, with an antioxidant action which is particularly useful in the treatment of circulation and chronic degenerative problems and in the treatment of hypertension, characterized in that its active ingredients comprise Ginkgo biloba biflavones, catechin and/or epicatechin, 4 cumarin and derivatives thereof and a component selected from among madecassic acid, asiatic acid, asiaticoside or combinations thereof isolated from Centella asiatica. Indian Patent application IN183285 describes an improved process for the extraction of asiaticoside useful as an antileprotic agent from the plant Centella asiatica Background of the invention Centella asiatica belongs to the family Apiaceae is a trailing herb that loves moist places and has rounded simple leaves, slender stems and inconspicuous flowers form in short clusters. The herb centella has been used extensively, internally and externally, as a medicine since the 17th century in Africa, India, the Philippines, Java and France. Centella asiatica is perennial, and known by many names, including Indian pennywort, Brahmi, Chi-hsueh, Ts'ao, Talepetraco, In India, where this is known as Brahmi (bringing knowledge of Brahman), it is widely used as a blood purifier as well as for treating a variety of other illnesses. Pennywort {Centella asiatica) or wild violet as it is also known, is indigenous to Africa, India and Australia. The ancient Indians ate two leaves a day for anti-raging and for tired looking skin. They also used it to treat leprosy sores, syphilis, leg ulcers, slow-healing wounds, venereal sores, tuberculosis, skin lesions and psoriasis. In Ayurveda, this plant is one of the chief herbs for revitalizing the nerves and brain cells. Eastern healers relied on Centella asiatica to treat emotional disorders, such as depression, that were thought to be rooted in physical problems. In Western medicine during the middle of the twentieth century, this plant and its alcoholic extract showed positive results in the treatment of leprosy. It is called the tiger herb in India, due to the fact that wounded tigers roll themselves in Centella. In Africa they used it to cure syphilis and to treat open and infected wounds. Chinese physicians used it for longevity and to treat fevers, colds and influenza. 5 It has excellent properties that deal with venous insufficiency, wound healing and which act as a general tonic. The plant and its extract contain asiaticoside an active principle of C. asiatica, in which a trisaccharide moiety is linked to the aglycone asiatic acid. The other triterpenoid derivative isolated from C. asiatica, also called madecassol, is a component of scar removal creams. These triterpene saponins and their sapogenins are mainly responsible for the wound healing and vascular effects. Other components isolated from G asiatica, such as brahmoside and brahminoside, may be responsible for CNS and uterorelaxant actions, but are yet to be confirmed by clinical studies. Crude extract that contains isothankuniside and thankuniside showed antifertility action in mice. Centelloside and its derivatives are found to be effective in the treatment of venous hypertension. In addition, the total extract contains plant sterols, flavonoids, and other components with no known pharmacological activity. The main use of centella is in wound healing and promoting healthy tissue. It is used to prevent the formation of scar tissue as well as to treat leprous ulcers. It is also used to treat stomach and duodenal ulcers, while acting as a multifunctional tonic - better known as an adaptogen. Centella asiatica appears to exert its anxiolytic and anti-stress activity by depressant action on the central nervous system (CNS), involving an increase in the concentration of GABA (gamma-aminobutyric acid) in the brain. It improves circulation in veins as well as capillaries, stimulates hair and nail growth, increases vascularisation of connective tissue and helpful in treating arthitis. Furthermore, it also is helpful to minimize varicose veins, as it appears to enhance blood flow, increasing the tone of the connective tissue sheath that surrounds the veins, and helps to maintain the suppleness of the veins. The asiaticosides and triterpenes isolated from Centella asiatica have modulating properties on the development and metabolism of connective tissue, improve the synthesis of collagen and other tissue proteins by modulating the action of fibroblasts in the vein wall, and stimulate collagen remodeling in and around the venous wall. Therefore the active ingredients improve wound repair, with a better re-epithialisation 6 and a normalization of perivascular connective tissue. The saponins present in the plant species also prevent excessive scar formation, by modulating and slowing down the excessive production of collagen (the material that makes up connective tissue) at the wound site and also increases the concentration of antioxidants in wounds. Various studies have supported these actions of centella and furthermore have been shown to be effective in treating surgical wounds, skin grafts, gangrene, traumatic injuries, burns, chronic skin lesions, ulcers and even leprosy wounds. It has great importance in preventing and correcting venous insufficiency. It helps provide treatment for leprosy and skin tuberculosis, as the bacteria are coated in a wax-like substance that the body's immune system cannot penetrate, but this waxy coating is dissolved by centella, thereby allowing the body's immune system to destroy the bacteria. Apart from this it also has anti-psoriatic properties. The growing number of herbal preparations on the market, including Centella asiatica, raised the possibility of complications related to improper use of these products, or the lack of medical supervision. So a novel method has been developed to prepare a herbal preparations from the plant Centella asiatica which was used for the treatment of various kind of diseases like hepatitis, high blood pressure, diabetes, asthma and wound healing. Description of the Invention Collection and Identification of the Plant Material. : The plant Centella asiatica was collected from Baruipur, South 24 Parganas area and authenticated from Botanical Survey of India, Indian Botanic Garden, Howrah. Preparation of the Extract : In one embodiment of the present invention fresh plant materials of Centella asiatica were collected from Baruipur, South 24 Parganas area, air dried, powdered and soaked in cold water or alcohol or mixture of water and alcohol (1:1) and kept in a refrigerator for 3-10 days. Then it was filtered under vaccum and filtrate was collected. Defatted plant material was again soaked in water and kept in the refrigerator for 3-10 days and it was filtered under vaccum and filtrate was collected. Successive extraction with cold water or alcohol or mixture of water and alcohol was repeated for 2-5 times. The filtrates were combined and it was concentrated under 7 reduced pressure at a temperature 30-40°C and lyophilized to obtain the crude powdered extract. Crude powdered extract of Centella asiatica was titurated with Petroleum-Ether (bp 40-60°C) for 2-5times with continuous stirring and petroleum ether extract was discarded. The residual part of the crude extract was air dried and mixed with 3-5 times by weight of an suitable adsorbent and a minimum amount of an organic solvent was added to the mixture to prepare a slurry. This slurry mixture was kept in a desicator for 10-15 days. Then this crude slurry mixture was soaked in water or alcohol or mixture of water and alcohol in suitable proportion and was kept in the refrigerator for 2-5 days and it was filtered under vaccum. Water or alcohol of mixture of water-alcohol extract was washed with an organic solvent of low boiling range in a separating funnel and washing process was repeated for 3-6 times. The extract was concentrated under reduced pressure and concentrated extract was lyophilzed to obtain the powdered extract. In the preferred embodiment of the invention 500 gm air dried & powdered fresh plant materials (whole parts) of Centella asiatica were soaked in the mixture of water and alcohol (1:1) and kept in the refrigerator (temp 4-6°C) for 5-8 days and it was filtered under vacuum and filtrate was collected. Successive extraction with mixture of water and alcohol was repeated for three times. The filtrates were combined and it was concentrated under reduced pressure at a temperature 35°C and lyophilized to obtain the crude powdered extract. Crude powdered extract of Centella asiatica was titurated with Petroleum-ether (bp 40-60°C) for 2-5 times with continuous stirring and petroleum ether extract was discarded. The residual part of the crude extract was air dried and mixed with 3-5 times by weight of an suitable adsorbent like silica gel (100-120 mesh) or cellulose preferably silica gel (100-120 mesh) and a minimum amount of an non polar organic solvent like n-hexane or benzene was added to the mixture to prepare a slurry. This slurry mixture was kept in a desicator for 10-15 days. Then this crude slurry mixture was soaked in the mixture of water and alcohol in suitable proportion preferably 1:1 and was kept in the refrigerator for 2-5 days and it was filtered under vacuum. Water-alcohol extract was washed with an organic solvent of low boiling range like petroleum ether (40-60oC) in a separating funnel and washing process was repeated for 3-6 times. The extract was concentrated under reduced pressure and concentrated extract was lyophilzed 8 to obtain the powdered extract. This novel and unique process was adopted to obtain the herbal product from the whole plant of Centella asiatica. This herbal preparation was successfully used for the treatment of liver diseases. People suffering from asthma were cured by the application of this herbal preparation. This herbal preparation was also applied to the people suffering from diabetes and a very good result was also obtained. Some viral diseases like influenza were also cured with the help of this medicine. This medicine can also be applied to cure gallstone, Kidney stone and Cancer. The exact dose and mode of application of this herbal preparation can vary among individuals. Different embodiments of the invention are possible to achieve the best process of performance and to obtain the good quality of product for better effect as stated earlier. It will be understood that skilled persons with many modifications, variations and adaptations may carry out the invention into practice without departing from its sprit or exceeding the scope of claims in describing the invention for the purpose of illustration. 9 I Claim 1. A process for preparing a herbal medicine for the treatment of liver diseases, asthma, diabetes and viral diseases from the whole plant of Centella asiatica comprising : i) air-dried and powdered plant material of Centella asiatica were soaked in water or alcohol or mixture of water and alcohol in a suitable proportion and kept in a refrigerator for 3-10 days. ii) extract was filtered under vacuum and this extraction process was repeated for 2-5 times; filtrates were combined and concentrated under reduced pressure and lyophilized to obtain the powdered extract iii) powdered extract was titurated with petroleum ether (40-60°C) for 2-5 times with continuous stirring and petroleum ether extract was discarded. iv) the residual part of the crude extract was air dried and mixed with 3-5 times by weight of an suitable adsorbent like silica gel (100-120 mesh) or cellulose preferably silica gel (100-120 mesh) and a minimum amount of an non polar organic solvent like n-hexane or benzene was added to the mixture to prepare a slurry. This slurry mixture was kept in a desicator for 10-15 days. v) then this crude slurry mixture was soaked in the mixture of water and alcohol in suitable proportion preferably 1:1 and was kept in the refrigerator for 2-5 days and it was filtered under vacuum. vi) water-alcohol (1:1) extract was washed with an organic solvent of low boiling range like petroleum ether (40-60°C) in a separating funnel and washing process was repeated for 3-6 times. The extract was concentrated under reduced pressure and concentrated extract was lyophilized to obtain the powdered extract. 2. A process for preparing a herbal medicine for the treatment of liver diseases, asthma, diabetes and viral diseases from the whole plant of Centella asiatica as claimed in 10 claim 1 wherein air dried plant material of Centella asiatica soaked in the mixture of water and alcohol (1:1) and kept in the refrigerator for 5-8 days. 3. A herbal medicine for the treatment of liver diseases, asthma, diabetes and viral diseases from the whole plant of Centella asiatica comprising : i) air-dried and powdered plant material of Centella asiatica were soaked in water or alcohol or mixture of water and alcohol in a suitable proportion and kept in a refrigerator for 3-10 days. ii) extract was filtered under vacuum and this extraction process was repeated for 2-5 times; filtrates were combined and concentrated under reduced pressure and lyophilized to obtain the powdered extract iii) powdered extract was titurated with petroleum ether (40-60°C) for 2-5 times with continuous stirring and petroleum ether extract was discarded. iv) the residual part of the crude extract was air dried and mixed with 3-5 times by weight of an suitable adsorbent like silica gel (100-120 mesh) or cellulose preferably silica gel (100-120 mesh) and a minimum amount of an non polar organic solvent like n-hexane or benzene was added to the mixture to prepare a slurry. This slurry mixture was kept in a desicator for 10-15 days. v) then this crude slurry mixture was soaked in the mixture of water and alcohol in suitable proportion preferably 1:1 and was kept in the refrigerator for 2-5 days and it was filtered under vacuum. vi) water-alcohol (1:1) extract was washed with an organic solvent of low boiling range like petroleum ether (40-60°C) in a separating funnel and washing process was repeated for 3-6 times. The extract was concentrated under reduced pressure and concentrated extract was lyophilized to obtain the powdered extract. 11 4. A herbal medicine for the treatment of Liver diseases, asthma, diabetes and some viral diseases from the whole plant of Centella Asiatics as claimed in claim 3 wherein air dried plant materia! of Centella Asiatica soaked in the mixture of water and alcohol (1:1) and kept in the refrigerator for 5-8 days. 5, A process for preparing a herbal medicine for the treatment of Liver diseases, asthma, diabetes and some viral diseases from the whole plant of Centella Asiatica as claimed in claim 1 wherein the dosage form is selected from the group consisting of a liquid preparation, a tablet, a capsule, a powder, an injectable preparation, pellets and granules. 6. A process for preparing a herbal medicine for the treatment of Liver diseases, asthma, diabetes and some viral diseases from the whole plant of Centella Asiatica as claimed in the preceding claims substantially herein described. 7, A process for preparing a herbal medicine for the treatment of Liver diseases, asthma, diabetes, Kidney, Gall Stone, Cancer and some viral diseases from the whole plant of Centella Asiatica as claimed in the preceding claims substantially herein described. This invention relates to the process for the preparation of a herbal medicine from the plant Centella Asiatica which can be used for the treatment of Kidney, Gallstone, Cancer, Asthma and liver diseases. This herbal preparation was also successfully used for the treatment of diabetes and some viral diseases. This herbal preparation was carried out by soaking the whole plant material of Centella Asiatica in the mixture of water and alcohol in a suitable proportion and some unique processes were applied resulting in the formation of a powdered extract which was used in different manner to combat the aforesaid diseases.

Documents:

00356-kol-2005-abstract.pdf

00356-kol-2005-claims.pdf

00356-kol-2005-correspondence.pdf

00356-kol-2005-description(complete).pdf

00356-kol-2005-form-1.pdf

00356-kol-2005-form-2.pdf

00356-kol-2005-form-3.pdf

00356-kol-2005-letters patent.pdf