Natural composition for curing hepatitis-B, methods for making the same and pharmaceutical formulations thereof

Abstract

Disclosed herein is a natural antiviral composition comprising extracts of plant Cyperus rotundus and/or plant Cyperus scariosus and a pharmaceutically acceptable carrier. Also disclosed are methods of making the plant extract, methods for preparing the composition and methods of treating diseases related to acute and chronic hepatitis B and other viral diseases of the liver.

1 . A natural herbal composition for curing Hepatitis-B comprising the extracts of plant  Cyperus rotundus  and/or plant  Cyperus scariosus  and a pharmaceutically acceptable carrier.  
     
     
         2 . The natural herbal composition according to  claim 1 , wherein the extracts of plant  Cyperus rotundus  and/or plant  Cyperus scariosus  is obtained from any or all parts of said plant  Cyperus rotundus  and/or plant  Cyperus scariosus.    
     
     
         3 . The natural herbal composition according to  claim 1 , wherein the extracts of plant  Cyperus rotundus  and/or plant  Cyperus scariosus  is obtained from the root and/or rhizome of plants  Cyperus rotundus  and/or  Cyperus scariosus.    
     
     
         4 . The natural herbal composition according to  claim 1 , wherein the composition comprises an equimolar mixture of methanolic extract of rhizomes/roots of plant  Cyperus rotundus  and rhizomes/roots of  Cyperus scariosus.    
     
     
         5 . The natural herbal composition according to  claim 1 , wherein the composition comprises a methanolic extract of rhizomes/roots of plant  Cyperus rotundus.    
     
     
         6 . The natural herbal composition according to  claim 1 , wherein the composition comprises a methanolic extract of rhizomes/roots of plant  Cyperus scariosus.    
     
     
         7 . A natural herbal composition according to  claim 1 , comprising a therapeutically effective amount of extracts of plant  Cyperus rotundus  and/or  Cyperus scariosus  comprising Alkaloids, Bitters, Glycosidic compounds, Tannins, Fixed oils, Procyanidins, Anthraquinone glycosides, Flavonoids, Terpenoids, Terpenoid glycosides and amino acids as active constituents.  
     
     
         8 . The natural herbal composition according to  claim 1 , wherein the composition is in an oral dosage form.  
     
     
         9 . A delivery system for orally administering the natural composition according to  claim 8 , wherein the delivery system comprises tablets, capsules, pills, granules, syrups, powders, concentrates or dry syrups.  
     
     
         10 . The delivery system according to  claim 9 , wherein the delivery system is syrup.  
     
     
         11 . The delivery system according to  claim 10 , wherein the syrup comprises a therapeutically effective amount of extracts of plants  Cyperus rotundus  and/or  Cyperus scariosus  in an amount of 50 mg to 500 mg and pharmaceutically acceptable carriers, the carrier comprising Sugar D 30 (3.4 to 3.75 gm), Citric acid (0.01 to 0.02 mg), Methyl paraben sodium (0.01 mg), Propyl paraben sodium (0.0025 mg), Strawberry flavor (0.005 mg) and DM Water (Qs) per 5 ml of dosage form.  
     
     
         12 . The delivery system according to  claim 9 , wherein the delivery system is granules.  
     
     
         13 . The delivery system according to  claim 12 , wherein the granules comprises a therapeutically effective amount of extracts of plants  Cyperus rotundus  and/or  Cyperus scariosus  in an amount of 50 to 500 mg and pharmaceutically acceptable carriers, the carrier comprising Microcrystalline cellulose (100 to 450 mg), P.G. Starch (about 50 mg), Lactose (50 to 300 mg), Dibasic calcium phosphate (50 to 250 mg), DM Water (Qs) per 300 to 900 mg of dosage form.  
     
     
         14 . The delivery system according to  claim 9 , wherein the delivery system is a tablet.  
     
     
         15 . The delivery system according to  claim 14 , wherein the tablet comprises the granules (500 to 900 mg) and pharmaceutically acceptable carriers, the carrier comprising Sodium starch glycolate (about 30 mg), Calcium carbonate (about 14 mg), Cabosil M5 (about 3 mg) and Magnesium stearate (about 3 mg).  
     
     
         16 . The delivery system according to  claim 9 , wherein the delivery system is a capsule.  
     
     
         17 . The delivery system according to  claim 16 , wherein the capsule comprises the granules (300 to 500 mg) and pharmaceutically acceptable carriers, the carrier comprising Cabosil M5 (about 2 mg) and Magnesium stearate (about 3 mg).  
     
     
         18 . A natural herbal composition according to  claim 8 , wherein the composition comprises a potency equivalent of the extract ranging from about 5 mg to about 2000 mg.  
     
     
         19 . The natural herbal composition according to  claim 1 , wherein the composition is capable of being used in the treatment of hepatitis-B and other related viral diseases.  
     
     
         20 . The natural herbal composition according to  claim 19 , wherein the composition is capable of being used in the treatment of Hepatitis-B disease, for suppression of production of HBsAg, inhibition of reverse transcriptase enzyme, destabilization of ccc DNA, stimulation of the immune system by the way of macrophage activation, proinflammatory cytokine production and Nitric oxide production and in reversing the oxidative damage by hepatotoxic agent and there by offer complete protection to the hepatocytes.  
     
     
         21 . A method of treating hepatitis-B and other related viral diseases by administering to a patient suffering from such disease, the composition comprising a therapeutically effective amount of extracts of plants  Cyperus rotundus  and/or  Cyperus scariosus  in a pharmaceutically acceptable carrier.  
     
     
         22 . The method according to  claim 21  further comprising treating other viral diseases including HIV, liver disorders such as liver cirrhosis, hepato-cellular carcinomas thereof, by administering the natural herbal composition comprising a therapeutically effective amount of extracts of plants  Cyperus rotundus  and/or  Cyperus scariosus  in a pharmaceutically acceptable carrier.  
     
     
         23 . The method according to  claim 21  further comprising administering a natural herbal composition comprising a therapeutically effective amount of extracts of plants  Cyperus rotundus  and/or  Cyperus scariosus  in a pharmaceutically acceptable carrier for inhibiting HBV-DNA polymerase enzyme production.  
     
     
         24 . The method according to  claim 21  further comprising administering a natural herbal composition comprising a therapeutically effective amount of extracts of plants  Cyperus rotundus  and/or  Cyperus scariosus  in a pharmaceutically acceptable carrier for clearance of HBsAg in circulation and suppression of HBsAg production.  
     
     
         25 . The method according to  claim 21  further comprising administering a natural herbal composition comprising a therapeutically effective amount of extracts of plants  Cyperus rotundus  and/or  Cyperus scariosus  in a pharmaceutically acceptable carrier for inhibiting Reverse Transcriptase enzyme.  
     
     
         26 . The method according to  claim 21  further comprising administering a natural herbal composition comprising a therapeutically effective amount of extracts of plants  Cyperus rotundus  and/or  Cyperus scariosus  in a pharmaceutically acceptable carrier for preventing liver cell toxicity by hepatitis virus and other hepatotoxic agents.  
     
     
         27 . The method according to  claim 21  further comprising administering a natural herbal composition comprising a therapeutically effective amount of extracts of plants  Cyperus rotundus  and/or  Cyperus scariosus  in a pharmaceutically acceptable carrier to potentiate the immune system of HBV infected patients towards viral clearance and protective antibody (anti HBs) responses.  
     
     
         28 . A method of producing a natural herbal composition, the method comprising extracting  Cyperus rotundus  rhizomes and/or roots by percolation, filtering the plant extract, concentrating the plant extract to dryness on rotatory evaporator or on steam bath at optimum temperature and producing a herbal composition comprising said dry extract and a pharmaceutically acceptable carrier.  
     
     
         29 . A method of producing a natural herbal composition, the method comprising extracting plant extract from  Cyperus rotundus  rhizomes and/or roots by hot soxhalation, filtering the plant extract, concentrating the plant extract to dryness on rotatory evaporator or on steam bath at optimum temperature and producing a herbal composition employing said dry extract and a pharmaceutically acceptable carrier.  
     
     
         30 . A method of producing a natural herbal composition, the method comprising extracting plant extract from  Cyperus scariosus  rhizomes and/or roots by percolation, filtering the plant extract, concentrating the plant extract to dryness on rotatory evaporator or on steam bath at optimum temperature and producing a herbal composition employing said dry extract and a pharmaceutically acceptable carrier.  
     
     
         31 . A method of producing a natural herbal composition, the method comprising extracting plant extract from  Cyperus scariosus  rhizomes and/or roots by hot soxhalation, filtering the plant extract, concentrating the plant extract to dryness on rotatory evaporator or on steam bath at optimum temperature and producing a herbal composition employing said dry extract and a pharmaceutically acceptable carrier.  
     
     
         32 . A method of producing a natural herbal composition comprising extracting plant extract from  Cyperus rotundus  and/or  Cyperus scariosus  employing an organic solvent.  
     
     
         33 . The method of producing a natural herbal composition according to  claim 32 , wherein the organic solvent is selected from a group comprising n-hexane, chloroform, ethyl acetate, acetone, ethyl alcohol, methanol and water.  
     
     
         34 . The method of producing a natural herbal composition according to  claim 33 , wherein the organic solvent is preferably methanol and/or ethyl alcohol either alone or in combination with other organic solvents.  
     
     
         35 . A method for obtaining the bioactive fraction of extracts of plant  Cyperus rotundus  and/or  Cyperus scariosus  by subjecting said extract to bioassay-guided fractionation employing solvents viz. hexane, dichloromethane, ethyl acetate, methanol and water and the active fraction being ethyl acetate soluble fraction.  
     
     
         36 . The method according to  claim 35 , further comprising purifying active fraction of the extracts of plant  Cyperus rotundus  and/or  Cyperus scariosus  employing column chromatography over silicagel with gradient elution of dichloromethane, ethyl acetate and methanol.  
     
     
         37 . The method according to  claim 36 , wherein the purification employing 25% ethyl acetate in dichloromethane and 50% ethyl acetate in dichloromethane results in most purified active fractions J-8 and J-9 respectively.  
     
     
         38 . The method according to  claim 37 , wherein the most active purified fraction is J-9.  
     
     
         39 . The method according to  claim 38 , wherein the most active fraction (J-9) comprises sesqui terpene lactones, aurones, coumarins, phenolics and flavonoid glycosides.