Antiviral product

Abstract

The present invention relates to a novel antiviral product, its use in the treatment of hepatitis C, and its process of manufacture. More particularly it relates to a characterised product exhibiting antiviral activity against Hepatitis C virus (HCV). In one embodiment there is provided a single herb Astragalus extract, or an active fraction thereof, for use as an antiviral in the treatment of hepatitis C.

1 . A selective single herb  Astragalus  alcoholic extract characterized in that the extract of  Astragalus  is purified by at least a factor of 10 with reference to dried raw plant material, exhibits anti-HCV activity in a replicon assay, and comprises at least one marker selected from the group consisting of:
 Astragaloside I;   Formononetin-7-O-β-D-glucoside; and   3′-hydroxyl-formononetin-7-O-β-D-glucoside.   
     
     
         2 . A selective single herb  Astragalus  alcoholic extract as claimed in  claim 1  which is purified by a factor of 50 with reference to dried raw plant material. 
     
     
         3 . A selective single herb  Astragalus  alcoholic extract as claimed in  claim 2  which is purified by a factor of between 75 and 200 with reference to dried raw plant material. 
     
     
         4 . A selective single herb  Astragalus  alcoholic extract as claimed in  claim 1  which has been subjected to an ethanol-water precipitation process. 
     
     
         5 . A selective single herb  Astragalus  alcoholic extract as claimed in  claim 4  wherein the extract has been subject to a systematic solvent fractionation step with a plurality of solvents of different polarity. 
     
     
         6 . A selective single herb  Astragalus  alcoholic extract as recited in  claim 5  which is obtained from a dichloromethane fractionation or a solvent of similar polarity. 
     
     
         7 . A selective single herb  Astragalus  alcoholic extract as claimed in  claim 1 , wherein the single herb  Astragalus  alcoholic extract is from  Astragalus membranaceus  (Fisch) Bge. or  Astragalus membranaceus  Bge var.  Mongholicus  Hsiao. 
     
     
         8 . A selective single herb  Astragalus  alcoholic extract as claimed in  claim 1  packaged or otherwise sold in a manner which indicates it is suitable and intended for use as an anti-viral to treat hepatitis C. 
     
     
         9 . A selective single herb  Astragalus  alcoholic extract as claimed in  claim 1  and its use in the manufacture of a medicament for the anti viral treatment of Hepatitis C. 
     
     
         10 . A selective single herb  Astragalus  alcoholic extract as claimed in  claim 1  and the use thereof in the manufacture of a food, dietary supplement or food additive for the anti viral treatment of Hepatitis C. 
     
     
         11 . A selective single herb  Astragalus  alcoholic extract as claimed in  claim 8  wherein the  Astragalus  extract is provided in a unit dosage form. 
     
     
         12 . A selective single herb  Astragalus  alcoholic extract as claimed in  claim 8  wherein the unit dosage form is for oral delivery. 
     
     
         13 . A selective single herb  Astragalus  alcoholic extract as claimed in  claim 8  wherein a daily dosage is equivalent to 9 to 60 grams of raw material. 
     
     
         14 . A selective single herb  Astragalus  alcoholic extract as claimed in  claim 8  wherein administration is with at least one other immuno-modulatory or anti viral drug. 
     
     
         15 . A selective single herb  Astragalus  alcoholic extract as claimed in  claim 14  wherein the at least one other immuno-modulatory or anti viral drug is interferon or Ribavirin 
     
     
         16 . A method for producing a single herb extract of  Astragalus  which exhibits anti-HCV activity in a replicon assay, and which is purified by at least a factor of 10 with reference to dried raw plant material, and which is characterized in that it comprises at least one marker selected from the group consisting of:
 Astragaloside I;   Formononetin-7-o-β-d-glucoside; and   3′-hydroxyl-formononetin-7-o-β-d-glucoside comprising:
 a. an alcoholic extraction (which may be repeated); 
 b. an ethanol-water precipitation process (which may be repeated); and 
 c. a systematic solvent fractionation step with a plurality of solvents of different polarity. 
   
     
     
         17 . A method as claimed in  claim 16  in which the alcoholic extraction is an ethanolic extraction. 
     
     
         18 . A method as claimed in  claim 16  wherein the systematic solvent fractionation step with a plurality of solvents of different polarity comprises a dichloromethane fractionation or a fractionation with a solvent of similar polarity to dichloromethane. 
     
     
         19 . A selective single herb  Astragalus  alcoholic extract having a TLC fingerprint substantially as shown in at least one of  FIG. 4 ,  FIG. 5 , and  FIG. 6 .