Processes of making north american ginseng fractions, products containing them, and use as immunomodulators

Abstract

The invention is directed to chemical processes of preparing fractions from North American Ginseng ( Panax quinquefolium ) and pharmaceutical compositions containing these fractions. The products of the present invention may be used to stimulate the production of cytokines and/or antibodies, or as therapeutics targeted at conditions characterized by low immunity, such as the common cold, influenza, chronic fatigue syndrome, AIDS and cancer.

1 . A process of preparing ginseng fraction PQ 223 , the process comprising:
 (a) providing ginseng fraction PQ 2 ;   (b) fractionating the ginseng fraction PQ 2  to produce a first elution fraction and a second elution fraction, wherein the first elution fraction corresponds to a carbohydrate peak observed between 35 and 50 ml of elution volume and the second elution fraction corresponds to a carbohydrate peak observed between 50 and 85 ml of elution volume, as determined by gel filtration chromatography using the following materials:
 (1) a chromatographic column containing a matrix of a spherical cross-linked co-polymer of allyl dextran and N,N′-methylenebisacrylamide, having a bed dimension of 16×600 mm, a bed volume of 120 ml, and a fractionation range (MW) of 5000 to 250,000 for globular proteins and 1000 to 80,000 for dextrans, and 
 (2) an elution buffer of Tris-HCl containing 0.1 N HCl and 0.3 M NaCl at a pH of 7.0; and 
   (c) isolating and combining the first elution fraction and the second elution fraction to produce ginseng fraction PQ 223 .   
     
     
         2 . The method of  claim 1 , wherein ginseng fraction PQ 2  is fractionated using gel filtration chromatography. 
     
     
         3 . Ginseng fraction PQ 223 , produced according to the process of  claim 1 . 
     
     
         4 . A pharmaceutical composition, comprising the ginseng fraction PQ 223  of  claim 3  and a pharmaceutically acceptable carrier. 
     
     
         5 . A method for preparing a pharmaceutical composition suitable for treating a condition characterized by low immunity comprising combining an effective amount of the ginseng fraction PQ 223  of  claim 3 , and at least one pharmaceutically acceptable excipient; and optionally combining an effective amount of another medicament that is suitable for treating a condition characterized by low immunity. 
     
     
         6 . The method of  claim 5 , wherein the condition is common cold, influenza, chronic fatigue syndrome, AIDS or cancer. 
     
     
         7 . A method for stimulating the production of IL-1, IL-16 or TNF-α in cells, wherein said method comprises contacting said cells with an effective amount of the ginseng fraction PQ 223  according to  claim 3 . 
     
     
         8 . A method for activating B-lymphocyte proliferation and antibody production comprising using a ginseng fraction of  claim 3  for said activation. 
     
     
         9 . A method for activating B-lymphocyte proliferation and antibody production resulting from said B-lymphocyte proliferation, wherein said method comprises administering to a subject an effective amount of the ginseng fraction PQ 223  according to  claim 3 . 
     
     
         10 . A method of treating a condition characterized by low immunity in a patient in need thereof, comprising administering to the patient an effective amount of a ginseng fraction PQ 223  according to  claim 3 . 
     
     
         11 . The method of  claim 10 , wherein the condition is common cold, influenza, chronic fatigue syndrome, AIDS or cancer. 
     
     
         12 . A composition, comprising at least two of the following ginseng fractions:
 ginseng fraction PQ 2A ;   ginseng fraction PQ 2A ;   ginseng fraction PQ 2C ; and   ginseng fraction PQ 2D .