Processes of making North American ginseng fractions, products containing them, and use as immunomodulators

1. A process of preparing ginseng fraction PQ2, the process comprising:

(a) combining American ginseng with a C 1 -C 6 alcohol first solvent and heating the resulting solution at a temperature of about 80-100° C. for a time period of about 2-4 hours to produce a first ginseng solution;

(b) thereafter separating the first ginseng solution to produce an alcohol/ginseng solution and a first ginseng residue;

(c) thereafter combining the first ginseng residue with water and heating the resulting solution at a temperature of about 80-100° C. for a time period of about 2-4 hours to produce a ginseng residue solution;

(d) thereafter separating the ginseng residue solution to produce a second ginseng residue and a first aqueous extract solution containing a first ginseng extract;

(e) combining at least a part of the first ginseng extract and water to form a second aqueous extract solution, wherein in the second aqueous extract solution the proportion of the first ginseng extract to water is about 1:18 to 1:22;

(f) thereafter combining the second aqueous extract solution with a second solvent comprising an alcohol, wherein the proportion of the second solvent to water is about 1:1 to 3:5, to produce a first precipitate and a first supernatant;

(g) thereafter combining the first supernatant produced in step (f) with a third solvent comprising an alcohol, wherein the proportion of the third solvent to first supernatant is about 3:2 to 3:1, to produce a second precipitate and a second supernatant; and

(h) isolating the second precipitate to produce ginseng fraction PQ2.

2. The process of claim 1 , wherein the alcohol in each of the, second solvent and third solvent independently comprises a saturated or unsaturated C 1 -C 6 alcohol.

3. The process of claim 1 , wherein the alcohol in each of the first solvent, second solvent and third solvent independently comprises ethanol or methanol.

4. The process of claim 1 , wherein in step (e) the second aqueous extract solution comprises at least a part of the first aqueous extract solution.

5. The process of claim 1 , wherein in step (a) the resulting solution is heated for a time period of about 3 hours.

6. The process of claim 1 , wherein in step (c) the resulting solution is heated for a time period of about 3 hours.

7. The process of claim 1 , wherein in step (e) the proportion of the first ginseng extract to water is about 1:20.

8. The process of claim 1 , wherein in step (f) the proportion of the second solvent to water is about 3:4.

9. The process of claim 1 , wherein in step (g) the proportion of the third solvent to first supernatant is about 2:1.

10. The process of claim 1 , wherein in step (a) the first solvent and the ginseng are combined in a proportion of about 7-9 ml of first solvent per gram of ginseng.

11. The process of claim 1 , wherein in step (a) the first solvent and the ginseng are combined in a proportion of about 8 ml of first solvent per gram of ginseng.

12. The process of claim 1 , wherein in step (c) the water and the first ginseng residue are combined in a proportion of about 7-9 ml of water per gram of ginseng residue.

13. The process of claim 1 , wherein in step (c) the water and the first ginseng residue are combined in a proportion of about 8 ml of water per gram of ginseng residue.

14. Ginseng fraction PQ2, produced according to the process of any of claims 1 - 13 .

15. A pharmaceutical composition, wherein said pharmaceutical composition comprises the ginseng fraction PQ 2 according to claim 14 and a pharmaceutically acceptable carrier.

16. 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 2 according to claim 14 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.

17. The method of claim 16 , wherein the condition is selected from the group consisting of common cold, influenza, chronic fatigue syndrome, AIDS and cancer.

18. A method of stimulating the production of IL-1, IL-16 and/or TNF-α in cells, wherein said method comprises contacting said cells with an effective amount of the ginseng fraction PQ 2 according to claim 14 .

19. A method of 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 2 according to claim 14 .

20. 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 2 according to claim 14 .

21. The method of claim 20 , wherein the condition is selected from the group consisting of common cold, influenza, chronic fatigue syndrome, AIDS and cancer.

22. A method of stimulating the in vitro production of immunoglobulins, wherein said method comprises contacting cells with an effective amount of the ginseng fraction PQ 2 according to claim 14 .

23. A method of stimulating the in vivo production of immunoglobulins, wherein said method comprises administering to a subject an effective amount of the ginseng fraction PQ 2 according to claim 14 .

24. A method of stimulating the production of IL-1, IL-16 and/or TNF-α, wherein said method comprises administering to a subject an effective amount of the ginseng fraction PQ 2 according to claim 14 .

25. A method of activating B-lymphocyte proliferation and antibody production resulting from said B-lymphocyte proliferation, wherein said method comprises contacting cells with an effective amount of the ginseng fraction PQ 2 according to claim 14 .