METHOD OF PREPARING AND USING A COLD EXTRACT FROM THE LEAVES OF NERIUM OLEANDER

Abstract

A method of preparing and using a sterile non-toxic pyrogen-free cold extract from the leaves of Nerium oleander as a supplementary medication to cancer chemo-, hormon and/or radiotherapy to restore and/or ameliorate the immune system of the patient and/or to decrease side effects and increase the antitumor effects of radiotherapy and chemotherapeutics, particularly when used in combination with taxol, adriamycin, cisplatin, 5-fluoro-uracil, alimta, cyclophosphamide, mitomycin-C, navelbine, taxotere and topotecan, respectively, and its use in the manufacture of a medicament for the treatment of one or more cancers of bladder, kidney, liver, ovary, pancreas, testicle, uterus, and vagina as well as pleuramesotheliomas and Hodgkin's lymphomas.

Description

Claims

1. A method of preparing and using a sterile water-soluble non-toxic pyrogen-free cold extract from Nerium oleander containing oleandrin and other digoxin-type glycosides comprising the steps of: (i) soaking a dried powder, obtained from the leaves of Nerium oleander, in a sterile medium selected from distilled water, a water/ethanol mixture, a water/methanol mixture, methanol or ethanol, for a period of 1 to 50 hours at a temperature in a range of from 0 to 30° C.,(ii) filtering the resultant solution under sterile conditions, and(vi) administering an effective amount of the cold extract to a patient in need thereof as a supplementary medication to cancer chemo-, hormone- and/or radiotherapy to restore and/or ameliorate the immune system of the patient and/or to increase the antitumor effects of chemotherapeutics and radiotherapy and decrease side effects, respectively.

2. The method according to claim 1, wherein said cold extract is administered as a supplementary medication in cancer therapy in combination with taxol, adriamycin, cisplatin, 5-fluoro-uracil, alimpta, cyclophosphamide, mitomycin-C, navelbine, taxotere or topotecan by enhancing the antitumor activity and reducing side effects and stimulating immunological effector cells.

3. The method according to claim 1, wherein in step (i) active ingredients of Nerium oleander are extracted from the leaves of Nerium oleander having a length of 16 to 19 cm which are harvested during a period of from August to December.

4. The method according to claim 1, wherein step (i) is conducted at room temperature and under sterile conditions.

5. The method according to claim 17, wherein in step (iv) a filter having a pore size in a range of 0.22 to 0.45 μm is used.

6. The method according to claim 1, wherein the sterile extract has endotoxin concentrations of less than 30 units/ml.

7. The method according to claim 1, wherein the extract is obtainable by: (a) in step (i), rinsing the ground powder of Nerium oleander in a sterile medium selected from distilled water, a water/ethanol mixture, a water/methanol mixture, methanol or ethanol, for 4 to 24 hours at a temperature in a range of 0 to 30° C., and(b) in step (ii), filtering the obtained aqueous suspension several times and adjusting the pH value to a range of 5.7 to 6.0 under laminar flow conditions using a filter having a pore size in a range of 0.22 to 0.45 μm.

8. The method according to claim 1, wherein said cold extract is administered by intramuscular, oral, rectal and intravenous administration.

9. A method of preparing and using a sterile water-soluble non-toxic pyrogen-free cold extract from Nerium oleander containing oleandrin and other digoxin-type glycosides comprising the steps of: (i) soaking a dried powder, obtained from the leaves of Nerium oleander, in a sterile medium selected from distilled water, a water/ethanol mixture, a water/methanol mixture, methanol or ethanol, for a period of 1 to 50 hours at a temperature in a range of from 0 to 30° C.,(ii) filtering the resultant solution under sterile conditions, and(vi) administering an effective amount of the cold extract to a patient in need thereof for treatment of one or more cancers.

10. The method according to claim 9, wherein in step (i) active ingredients of Nerium oleander are extracted from the leaves of Nerium oleander having a length of 16 to 19 cm which are harvested during a period of from August to December.

11. The method according to claim 9, wherein step (i) is conducted at room temperature and under sterile conditions.

12. The method according to claim 20, wherein in step (iv) a filter having a pore size in a range of 0.22 to 0.45 μm is used.

13. The method according to claim 9, wherein the sterile extract has endotoxin concentrations of less than 30 units/ml.

14. The method according to claim 9, wherein the extract is obtainable by: (a) in step (i), rinsing the ground powder of Nerium oleander in a sterile medium selected from distilled water, a water/ethanol mixture, a water/methanol mixture, methanol or ethanol, for 4 to 24 hours at a temperature in a range of 0 to 30° C., and(b) in step (ii), filtering the obtained aqueous suspension several times and adjusting the pH value to a range of 5.7 to 6.0 under laminar flow conditions using a filter having a pore size in a range of 0.22 to 0.45 μm.

15. The method according to claim 9, wherein said cold extract is administered by intramuscular, oral, rectal and intravenous administration.

16. The method according to claim 1, further comprising (iii) adjusting the volume of the resultant solution to a predetermined volume.

17. The method according to claim 1, further comprising (iv) further filtration under sterile conditions.

18. The method according to claim 1, further comprising (v) spray drying or freeze drying of the filtrate under sterile conditions.

19. The method according to claim 9, further comprising (iii) adjusting the volume of the resultant solution to a predetermined volume.

20. The method according to claim 9, further comprising (iv) further filtration under sterile conditions.

21. The method according to claim 9, further comprising (v) spray drying or freeze drying of the filtrate under sterile conditions.

22. The method according to claim 9 wherein the one or more cancers are of bladder, kidney, liver, ovary, pancreas, testicle, uterus, vagina, pleuramesotheliomas and Hodgkin's lymphomas.