ANTIVIRAL PRODUCT
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 .