Processes of making north american ginseng fractions, products containing them, and use as immunomodulators
View Patent ↗The invention is directed to chemical processes of preparing fractions form 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 P 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, wherein said pharmaceutical composition comprises the ginseng fraction PQ 223 according to claim 3 and a pharmaceutically acceptable carrier.
5. A method of preparing a pharmaceutical composition suitable for treating a condition characterized by low immunity, wherein said method comprises combining an effective amount of the ginseng fraction PQ 223 according to claim 3 and, optionally, combining an effective amount of another medicament that is suitable for treating a condition characterized by low immunity, with at least one pharmaceutically acceptable excipient to produce a pharmaceutical composition suitable for treating a condition characterized by low immunity.
6. The method of claim 5 , wherein the condition is selected from the group consisting of common cold, influenza, chronic fatigue syndrome, AIDS and cancer.
7. A method of stimulating the production of IL-1, IL-6 and/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 of activating B-lymphocyte proliferation and antibody production resulting from said B-lymphocyte proliferation, wherein said method comprises administering to a subject in need thereof an effective amount of the ginseng fraction PQ 223 according to claim 3 .
9. 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 .
10. The method of claim 9 , wherein the condition is selected from the group consisting of common cold, influenza, chronic fatigue syndrome, AIDS and cancer.
11. A method for activating B-lymphocyte proliferation and antibody production there from, comprising administering an effective amount of the ginseng fraction PQ 223 according to claim 3 to a patient in need thereof.