Standardization of Botanical Products Utilizing Biological Activity as a Marker

Abstract

The present invention relates generally to herbal materials and methods for making such materials in medicinally useful and pharmaceutically acceptable forms. Particularly, the present invention relates generally to Hydrstatis canadensis (goldenseal) materials and methods for making such materials in medicinally useful and pharmaceutically acceptable forms. More particularly, the present invention relates a process which allows the standardization of the product to specified levels of bioactivity in both hydro-alcoholic tinctures and solid extracts in the processing of goldenseal materials to produce extracts which qualify as pharmaceutical grade compositions which are suitable for use in clinical or veterinary settings to treat and/or ameliorate diseases, disorders or conditions.

1 . A standardized process of reproducibly extracting the biological active components from a plant or plant part thereof in order to obtain a composition having a desired level of biological activity, wherein the plant produces berberine, the method comprising:
 (a) harvesting the plants or plant parts thereof;   (b) separating the various plant parts   (c) performing a plurality of solvent extractions of the separated plant parts using a selected solvent system in a plurality of separate extractions, to produce a plurality of crude extracts;   (d) sampling each of the plurality of crude extracts of step (c) and analyzing the samples to determine the level of biological activity of each of said samples compared to a reference standard having a known level of biological activity,   (e) obtaining a specified multiple or fraction of the biological activity of each such extract sample tested as compared to the reference standard,   (f) combining those crude extracts from the plurality of extracts to obtain a composition having the desired level of biological activity as compared to the reference standard,   (g) optionally concentrating the combined extract to remove the solvent to arrive at a composition having the desired level of biological activity.   
     
     
         2 . The method of  claim 1 , wherein the plant is selected from the group consisting of Ranunculales, Ranunculaseae,  Hydrastis  L.,  Hydrastis Canadensis  L. (goldenseal), Copti ( Coptis chinensis ), Barberry ( Berberis vulgaris ), Oregon grape ( Mahonia repens ) and Yerba mansa ( Anemopsis californica ). 
     
     
         3 . The process of  claim 1  wherein the reference standard comprises one or more alkaloid active components. 
     
     
         4 . The process of  claim 3  wherein the reference standard comprises berberine, hydrastine, or a combination thereof 
     
     
         5 . The process of  claim 1  wherein the separated parts are chopped up before the extractions. 
     
     
         6 . The process of  claim 1  wherein the separated parts are grounded into a powder before the extractions. 
     
     
         7 . A kit for use in a standard reproducible process for extracting a pharmacologically active mixture of chemical components from a plant material, the method comprising:
 (a) a solution for extracting a plurality of pharmacologically active mixtures of chemical components from a plant in a plurality of different extraction processes, to produce a plurality of extracts.   
     
     
         8 . The kit of  claim 7 , wherein the plant is a herb. 
     
     
         9 . The kit of  claim 7 , wherein the plant is selected from the group consisting of Ranunculales, Ranunculaceae,  Hydrastis  L.,  Hydrastis canadensis  L. (goldenseal),  Coptis  ( Coptis chinensis ), Barberry ( Berberis vulgaris ), Oregon grape ( Mahonia repens ) and Yerba mansa ( Anemopsis californica ). 
     
     
         10 . The kit of  claim 9  wherein the plant is a  Hydrastis.    
     
     
         11 . The kit of  claim 10 , wherein the  Hydrastis  is  Hydrastis canadensis  L. (goldenseal). 
     
     
         12 . The kit of  claim 7 , wherein the plant material is ground prior to being added to the extraction solution. 
     
     
         13 . The kit of  claim 7 , wherein the plant material is ground to a mesh size between about 10 and 80 mesh prior to being added to the extraction solution. 
     
     
         14 . The kit of  claim 7 , wherein the solution is a mixture of extraction solvents. 
     
     
         15 . The kit of  claim 7 , wherein the solution comprises a single solvent or a mixture of two or more of the solvents selected from the group consisting of acetone, acetonitrile, dichloromethane, ethyl acetate, ethanol, hexane, isopropanol, methanol, other alcohols, water, supercritical carbon dioxide and mixtures thereof.