Pharmaceutical Composition Made on Plant Raw Materials for Treating and Preventing Cancer

Abstract

A pharmaceutical composition containing dry powder of pine (Pinus) needles and dry peels and pits of grapes extract and pharmaceutically acceptable additive, dry extracts of ginger (Zingiber officinale), turmeric (Curcuma longa), white peony (Paeonia), Rhodiola Rosea (Rhodiola Rosea), apricot (Prunus) seed, oyster mushroom (Pleurotus ostreatus), green tea (Camellia sinensis), Ginkgo Biloba (Ginkgo biloba), white pepper, pomegranate (Punica granatum) pulp, medlar (Mespilus germanica), dry powder of pomegranate (Punica granatum) juice and folic acid, in the following ratio of the components in weight % (w %):

TABLE-US-00001 dry powder of pine needles and dry peels and pits of grapes extract and pharmaceutically acceptable additive 6-24 dry extract of ginger 6-25 dry extract of turmeric 5-24 dry extract of white peony 2-20 dry extract of Rhodiola Rosea 2-20 dry extract of apricot seed 5-20 dry extract of oyster mushroom 10-34 dry extract of green tea 12-35 dry extract of Ginkgo Biloba 2-25 dry extract of white pepper 1-15 dry extract of pomegranate pulp 2-20 extract of medlar 2-20 dry powder of pomegranate juice 2-25 folic acid 3-30

Claims

1. A pharmaceutical composition based on plant raw materials comprising dry powder of pine needles and dry peels and pits of grapes extract and pharmaceutically acceptable additive, dry extracts of ginger, turmeric, white peony, Rhodiola Rosea, apricot seed, oyster mushroom, green tea, Ginkgo Biloba, white pepper, pomegranate pulp, medlar, dry powder of pomegranate juice and folic acid, in the following ratio of the componentsin w%: TABLE-US-00011 dry powder of pine needles and dry peels and pits of grapes extract and pharmaceutically acceptable additive 6-24 dry extract of ginger 6-25 dry extract of turmeric 5-24 dry extract of white peony 2-20 dry extract of Rhodiola Rosea 2-20 dry extract of apricot seed 5-20 dry extract of oyster mushroom 10-34 dry extract of green tea 12-35 dry extract of Ginkgo Biloba 2-25 dry extract of white pepper 1-15 dry extract of pomegranate pulp 2-20 extract of medlar 2-20 dry powder of pomegranate juice 2-25 folic acid 3-30 .

2. The composition, according to claim 1, wherein it contains components in the following ratio in w%: TABLE-US-00012 dry powder of pine needles and dry peels and pits of grapes extract and harmaceutically acceptable additive 7 dry extract of ginger 8 dry extract of turmeric 10 dry extract of white peony 12 dry extract of Rhodiola Rosea 10 dry extract of apricot seed 7 dry extract of oyster mushroom 10 dry extract of green tea 12 dry extract of Ginkgo Biloba 7 dry extract of white pepper 3 dry extract of pomegranate pulp 3 extract of medlar 5 dry powder of pomegranate juice 3 folic acid 3 .

3. Medicament, comprising the composition according to claims 1-2.

4. Medicament, according to claim 3, wherein it has a form of a capsule.

5. Medicament, according to claim 4, wherein it comprises the composition, according to claims 1-2, in amount of 400-480 mg.

6. Medicament, according to claim 5, wherein it comprises the composition, according to claims 1-2, in amount of 450 mg.

Description

FULL DISCLOSURE OF THE INVENTION

[0022] One object of the invention is the pharmaceutical composition, which contains dry powder of pine (Pinus) needles and dry peels and pits of grapes extract and pharmaceutically acceptable additive, dry extracts of ginger (Zingiber officinale), turmeric (Curcuma longa), white peony (Paeonia), Rhodiola Rosea (Rhodiola Rosea), apricot (Prunus) seed, oyster mushroom (Pleurotus ostreatus), green tea (Camellia sinensis), Ginkgo Biloba (Ginkgo biloba), white pepper, pomegranate (Punica granatum) pulp, medlar (Mespilus germanica), dry powder of pomegranate (Punica granatum) juice and folic acid, in the following ratio of the components in w %:

TABLE-US-00004 dry powder of pine needles and dry peels and pits of grapes extract and pharmaceutically acceptable additive 6-24 dry extract of ginger 6-25 dry extract of turmeric 5-24 dry extract of white peony 2-20 dry extract of Rhodiola Rosea 2-20 dry extract of apricot seed 5-20 dry extract of oyster mushroom 10-34 dry extract of green tea 12-35 dry extract of Ginkgo Biloba 2-25 dry extract of white pepper 1-15 dry extract of pomegranate pulp 2-20 extract of medlar 2-20 dry powder of pomegranate juice 2-25 folic acid 3-30

[0023] As a result of long-term experimental studies, inventors have found that the components in the composition have a synergistic effect, in terms of anticancer effect, which is most likely due to their combined impact on apoptosis regulatory factors.

[0024] The composition is prepared as follows: initially, the components included in the composition are prepared separately. Extract of pine needles and dry peels and pits of grapes is prepared according to the method described in Georgian Patent GE5361. Liquid pharmaceutically acceptable additive is added to the obtained extract, preferably sucrose. The extract and the pharmaceutically acceptable additive are mixed in the same ratio as described in Georgian Patent GE5361. Finally obtained mixture is dried till making a dry powder. Drying is possible by any method known in the pharmaceutical industry, preferably spray drying is used. Extracts of ginger, turmeric, white peony, Rhodiola Rosea, apricot seed, oyster mushroom, green tea, Ginkgo Biloba, white pepper, pomegranate pulp, medlar are prepared separately. Extracts are prepared by any technology known in the pharmaceutical industry. Obtained liquid extracts are dried separately. Drying is possible by any method known in the pharmaceutical industry, preferably spray drying is used. Finally, dry extracts are obtained. Pomegranate juice is obtained by any known technology, preferably by pressing. Obtained juice is dried. Drying is possible by any method known in the pharmaceutical industry, preferably spray drying is used. Finally, dry powder is obtained. The powders obtained separately by the method described above are mixed together until a homogeneous mass is obtained, after which folic acid is added and stirring continuous. The components are mixed in such a ratio that the finally obtained composition contains ingredients in the following ratio in w%:

TABLE-US-00005 dry powder of pine needles and dry peels and pits of grapes extract and pharmaceutically acceptable additive 6-24 dry extract of ginger 6-25 dry extract of turmeric 5-24 dry extract of white peony 2-20 dry extract of Rhodiola Rosea 2-20 dry extract of apricot seed 5-20 dry extract of oyster mushroom 10-34 dry extract of green tea 12-35 dry extract of Ginkgo Biloba 2-25 dry extract of white pepper 1-15 dry extract of pomegranate pulp 2-20 extract of medlar 2-20 dry powder of pomegranate juice 2-25 folic acid 3-30

[0025] One more object of the invention is a medicament. In preferable version of the embodiment of the invention the medicament has a form of a capsule. In order to obtain the medicament in a form of a capsule, gelatinous capsules are filled with the above mentioned composition, by the method well-known in the pharmaceutical industry. In preferable version of the invention embodiment the capsule contains the composition in the amount of 400-480 mg, in more preferable version in the amount of 450 mg.

[0026] Indications for using the medicament are as follows: treatment and prevention of cancer of different localization.

[0027] Dosage of the medicament (preferably capsule) is 400-480 mg (one capsule) 2-3 times per day. Peroral administration of the medicament is possible, though it is better to dissolve the powder contained in the medicament (for example a capsule) in 32° C. preboiled water and take it orally in a form of liquid. The medicament is administered 15-30 minutes before eating.

Specific Examples of Carrying Out of the Invention

Example 1

[0028] The composition contains the components in the following ratio in mg:

TABLE-US-00006 dry powder of pine needles and dry peels and pits of grapes extract and pharmaceutically acceptable additive 31.5 dry extract of ginger 36 dry extract of turmeric 45 dry extract of white peony 54 dry extract of Rhodiola Rosea 45 dry extract of apricot seed 31.5 dry extract of oyster mushroom 45 dry extract of green tea 54 dry extract of Ginkgo Biloba 31.5 dry extract of white pepper 13.5 dry extract of pomegranate pulp 13.5 extract of medlar 22.5 dry powder of pomegranate juice 13.5 folic acid 13.5 total mass of the composition 450 mg

Example 2

[0029] The composition contains the components in the following ratio in mg:

TABLE-US-00007 dry powder of pine needles and dry peels and pits of grapes extract and pharmaceutically acceptable additive 28 dry extract of ginger 32 dry extract of turmeric 40 dry extract of white peony 48 dry extract of Rhodiola Rosea 40 dry extract of apricot seed 28 dry extract of oyster mushroom 40 dry extract of green tea 48 dry extract of Ginkgo Biloba 28 dry extract of white pepper 12 dry extract of pomegranate pulp 12 extract of medlar 20 dry powder of pomegranate juice 12 folic acid 12 total mass of the composition 400 mg

Example 3

[0030] The composition contains the components in the following ratio in mg:

TABLE-US-00008 dry powder of pine needles and dry peels and pits of grapes extract and pharmaceutically acceptable additive 34 dry extract of ginger 39 dry extract of turmeric 44 dry extract of white peony 53 dry extract of Rhodiola Rosea 45 dry extract of apricot seed 35 dry extract of oyster mushroom 48 dry extract of green tea 58 dry extract of Ginkgo Biloba 34 dry extract of white pepper 17.5 dry extract of pomegranate pulp 17.5 extract of medlar 20 dry powder of pomegranate juice 17.5 folic acid 17.5 total mass of the composition 480 mg

[0031] A number of researches have been carried out to study the effectiveness of the composition of the invention.

Example 1 (Effect on Protein P53 Expression)

[0032] Human lung cancer cells A549 were treated with the aqueous solution of the composition described in Example 1 at a concentration of 4 mg/ml for 24 hours, and as a control, lung cancer cells A549 were treated with pure water for 24 hours. Then, in both samples, p53 protein expression was determined by western blotting, which was three times higher than the control.

Example 2 (Effect on Apoptosis)

[0033] Human lung cancer cells A549 were treated with the aqueous solutions of the composition described in Examples 1-3, with a concentration of 4 mg/ml for 72 hours, and survival rates of the cells were determined by an MTT assay. As a control, human lung cancer cells A549 were treated with pure water for 72 hours. The results of the study are shown in Table 1.

TABLE-US-00009 Composition Version Survival Rate % Example 1 5 Example 2 7 Example 3 12 Survival rate % = average absorbance of experimental group (compositions)/average absorbance of control

Example 3 (Effect on the Cell Cycle G1)

[0034] Human lung cancer cells A549 were treated with the aqueous solution of the composition described in Example 1 at a concentration of 4 mg/ml for 24 hours. Cells were then stained with propidium iodide and cell cycle G1 was determined by flowing out cytometry. As a result of the study, it was found that the number of cells with arrested G1 cycle, increased to 86.4%, while in the control (lung cancer cells A549 were treated with pure water) this index was 54.8%.

Example 4 (Study of the Anti-Cancer Effect of the Composition)

[0035] Human colon cancer cells SW620 were used for the cancer line. A suspension of the mentioned cancer cells (1×10.sup.7 cell/ml) was administered to 40 mice subcutaneously, in amount of 0.3 ml/mouse. The mice were divided in 4 groups. The mice of the first group (study group) were given the aqueous solution of the composition described in Example 1 orally, with 5 mg/kg dosage of the active ingredient once a day for 20 days after the cancer cell transplantation. The mice of the second group (study group) were given the aqueous solution of the composition described in Example 2 orally, with 5 mg/kg dosage of the active ingredient once a day for 20 days after the cancer cell transplantation. The mice of the third group (study group) were given the aqueous solution of the composition described in Example 3, with 5 mg/kg dosage of the active ingredient once a day for 20 days after the cancer cell transplantation. The mice of the fourth group (control group) were given a 0.5% aqueous solution of Twin 80 with 10 ml/kg dosage once a day for 20 days after the cancer cell transplantation.

[0036] On days 8, 11, 14, 17, 20, and 22 after the cancer cell transplantation, tumor size was measured. On days 8, 10, 12, 14, 16, 18, 20 and 22 after the cancer cell transplantation, the weight of the mice was determined.

[0037] On day 22 after the cancer cell transplantation, all mice were killed, tumors were isolated and weighed.

[0038] There was no weight loss of mice in any of the study groups, as for the tumor size and mass, the data obtained from the study are shown in Table 2.

TABLE-US-00010 composition version tumor size reduction % compared to control tumor mass reduction % compared to control Example 1 71.8 68.3 Example 2 68.7 65.2 Example 3 64.5 61.1

[0039] Thus, the above studies have shown that the composition proposed by the invention increases the expression of p53 protein in cancer cells, which stimulates the process of apoptosis and arrest of the cell cycle G1, and therefore inhibits the proliferation of cancer cells.