Hepatocurative effect of emblica officinalis against CYP 450 bio-activation hepatotoxicity of drugs

Abstract

The present invention relates to a composition useful for hepatocurative effect against CYP 450 bio-activation hepatotoxicity induced by drugs, said composition comprising an extract from Emblica officinalis and optionally pharmaceutically acceptable additives and method of treating drug induced hepatotoxicity

1 . An orally-administered composition useful for treatment of CYP 450 bio-activated hepatotoxicity induced by at least one anti-TB drug selected from the group consisting of rifampicin, pyrazinamide, and isoniazid so as to restore liver function to normal, said composition comprising an substantially pure extract from  Emblica officinalis  and pharmaceutically acceptable additives, wherein the extract comprises from 8.5% to 15% by weight of tannin, said extract and said additives being in the ratio of 1:1-1:10, the additives being selected from a group of nutrients comprising proteins, carbohydrates, sugar, talc, magnesium stearate, cellulose, calcium carbonate, and starch-gelatin paste, and/or pharmaceutically acceptable carrier, excipient, diluent, or solvent, wherein said composition treats CYP 450 bio-activated hepatotoxicity induced by at least one anti-TB drug selected from the group consisting of rifampicin, pyrazinamide, and isoniazid so as to restore liver function to normal, but is not effective against hepatotoxicity which is independent of bio-activation by CYP 450. 
     
     
         2 - 4 . (canceled) 
     
     
         5 . A composition as claimed in  claim 1 , wherein said additives have no effect on hepatocurative effectiveness of the said extract. 
     
     
         6 . A composition as claimed in  claim 1 , wherein said extract is prepared by incubating said Emblica officinalis with a polar solvent at room temperature for about 15 to 25 hours so as to obtain said extract, said extract comprising from 8.5% to 15% by weight of tannin, and optionally adding pharmaceutically acceptable additives, wherein the polar solvent consists of (i) water, (ii) water and ethanol, or (iii) ethanol. 
     
     
         7 . (canceled) 
     
     
         8 . A composition as claimed in  claim 1 , wherein said composition is in form of capsule, tablet, syrup, concentrate, powder, granule, aerosol, and/or beads. 
     
     
         9 . A method of preparing an orally-administered composition useful for treatment of CYP 450 bio-activated hepatotoxicity induced by at least one anti-TB drug selected from the group consisting of rifampicin, pyrazinamide, and isoniazid so as to restore liver function to normal, said composition comprising an substantially pure extract from  Emblica officinalis  and pharmaceutically acceptable additives, wherein the substantially pure extract comprises from 8.5% to 15% by weight of tannin, said substantially pure extract and said additives being in the ratio of 1:1-1:10, the additives being selected from a group of nutrients comprising proteins, carbohydrates, sugar, talc, magnesium stearate, cellulose, calcium carbonate, and starch-gelatin paste, and/or pharmaceutically acceptable carrier, excipient, diluent, or solvent, wherein said composition treats CYP 450 bio-activated hepatotoxicity induced by at least one anti-TB drug selected from the group consisting of rifampicin, pyrazinamide, and isoniazid so as to restore liver function to normal, but is not effective against hepatotoxicity which is independent of bio-activation by CYP 450, said method comprising incubating said Emblica officinalis with a polar solvent at room temperature for about 15 to 25 hours so as to obtain the substantially pure extract, the substantially pure extract comprising from 8.5% to 15% by weight of tannin, and optionally adding pharmaceutically acceptable additives, wherein the polar solvent consists of (i) water, (ii) water and ethanol or (iii) ethanol. 
     
     
         10 . (canceled) 
     
     
         11 . A method as claimed in  claim 9 , wherein extract is from fresh and/or semi dried fruits of  Emblica Officinalis.    
     
     
         12 - 13 . (canceled) 
     
     
         14 . A method as claimed in  claim 9 , wherein said composition is in form of capsule, tablet, syrup, concentrate, powder, granule, aerosol, and/or beads. 
     
     
         15 - 38 . (canceled) 
     
     
         39 . A method for treating CYP 450 bio-activation hepatotoxicity induced by drugs comprising treating a mammalian with a hepatocurative effective amount of substantially pure extract from  Emblica officinalis  and optionally pharmaceutically acceptable additives.