Method for preparation of highly pure asiaticoside composition from centella asiatica and a method of use thereof

Abstract

Disclosed is a commercially viable asiaticoside composition having at least 99% purity that is derived from plant Centella asiatica and a manufacturing process thereof. Also disclosed is a method and the models for oral administration of therapeutically effective amounts of the asiaticoside composition for treatment of Inflammatory Bowel Diseases such as Ulcerative colitis, Crohn's disease and associated complications of inflammatory bowel diseases such as hemorrhoids, anal fissures, fistulas. Also disclosed is a method and model for oral administration of therapeutically effective amounts of the asiaticoside composition for treatment of Helicobacter Pylori , as well as a method and the models for oral administration of therapeutically effective amounts of the asiaticoside composition for prevention of colon cancer, gastric diseases and gastric carcinoma.

The invention claimed is: 
     
         1 . A method of treating a disease selected from the group comprising inflammatory Bowel Disease, hemorrhoid, anal fissure, fistula, gastric disease, gastric carcinoma and eradication of a  helicobacter pylori  infection or any combination thereof, said method comprising administering a dose of asiaticoside optionally along with pharmaceutically acceptable excipient(s) to a subject in need thereof. 
     
     
         2 . The method as claimed in  claim 1 , wherein said pharmaceutically acceptable excipient is selected from the group comprising granulating agents, binding agents, lubricating agents, disintegrating agents, sweetening agents, glidants, anti-adherents, anti-static agents, surfactants, anti-oxidants, gums, coating agents, colouring agents, flavouring agents, plasticizers, preservatives, suspending agents, emulsifying agents and spheronization agents, or any combination thereof. 
     
     
         3 . The method as claimed in  claim 1 , wherein said subject is an animal, including a human. 
     
     
         4 . The method as claimed in  claim 1 , wherein said composition is administered to animals at a dosage ranging from about 1 mg/kg to about 360 mg/kg. 
     
     
         5 . The method as claimed in  claim 1 , wherein said composition is administered to humans at a dosage ranging from about 1 mg/kg to about 60 mg/kg. 
     
     
         6 . A method of preventing a disease selected from the group comprising colon cancer, gastric disease, gastric carcinoma and ulcerogenic effect of drugs or any combination thereof, said method comprising administering a dose of asiaticoside optionally along with pharmaceutically acceptable excipient(s) to a subject in need thereof. 
     
     
         7 . The method as claimed in  claim 6 , wherein said pharmaceutically acceptable excipient is selected from the group comprising granulating agents, binding agents, lubricating agents, disintegrating agents, sweetening agents, glidants, anti-adherents, anti-static agents, surfactants, anti-oxidants, gums, coating agents, colouring agents, flavouring agents, plasticizers, preservatives, suspending agents, emulsifying agents and spheronization agents, or any combination thereof. 
     
     
         8 . The method as claimed in  claim 6 , wherein said subject is an animal, including a human. 
     
     
         9 . The method as claimed in  claim 6 , wherein said composition is administered to animals at a dosage ranging from about 1 mg/kg to about 360 mg/kg. 
     
     
         10 . The method as claimed in  claim 6 , wherein said composition is administered to humans at a dosage ranging from about 1 mg/kg to about 60 mg/kg.