PHARMACEUTICAL COMPOSITION FOR PREVENTING OR TREATING GYNECOLOGICAL DISEASES CONTAINING SARCODON ASPRATUS EXTRACTS AS ACTIVE INGREDIENT

Abstract

The present invention relates to a composition for prevention or treatment of gynecological diseases containing an extract of Sarcodon imbricatus as an active ingredient. Specifically, the extract of Sarcodon imbricatus of the present invention can be effectively used, with only one dose, for prevention or treatment of gynecological diseases by treating dysmenorrhea, reducing a menstrual period, an amount of menstruation, menstrual irregularity, and extravasated blood, and clearing the color of menstruation.

Claims

1. A method of preventing or treating gynecological diseases, the method comprising: administering a pharmaceutical composition to a subject, wherein: the pharmaceutical composition comprises Sarcodon aspratus extracts as active ingredients; the gynecological diseases are diseases caused by an imbalance of female hormones; the gynecological diseases are one or more selected from the group consisting of dysmenorrhea, premenstrual syndrome, and menstrual irregularity; the Sarcodon aspratus extracts are prepared by a method including: a first step of performing primary extraction at 45° C. to 50° C. for five minutes to one hour by adding water as an extraction solvent to Sarcodon aspratus; a second step of performing secondary extraction at 90° C. to 105° C. for five minutes to twenty minutes of the primary extracts obtained in the first step; a third step of filtering the extracts obtained in the second step; and a fourth step of concentrating the filtered extracts of the third step under reduced pressure and drying the concentrated extracts; and the Sarcodon aspratus extracts are obtained from fruit bodies of Sarcodon aspratus.

2. A method of preventing or treating gynecological diseases, the method comprising: administering a functional health food to a subject, wherein: the functional health food comprises Sarcodon aspratus extracts as active ingredients; the gynecological diseases are diseases caused by an imbalance of female hormones; the gynecological diseases are one or more selected from the group consisting of dysmenorrhea, premenstrual syndrome and menstrual irregularity; the Sarcodon aspratus extracts are prepared by a method including: a first step of performing primary extraction at 45° C. to 50° C. for five minutes to one hour by adding water as an extraction solvent to Sarcodon aspratus; a second step of performing secondary extraction at 90° C. to 105° C. for five minutes to twenty minutes of the primary extracts obtained in the first step; a third step of filtering the extracts obtained in the second step; and a fourth step of concentrating the filtered extracts of the third step under reduced pressure and drying the concentrated extracts; and the Sarcodon aspratus extracts are obtained from fruit bodies of Sarcodon aspratus.

Description

MODE FOR INVENTION

[0054] Hereinafter, the present invention will be described in detail through the following examples.

[0055] However, the following examples are merely illustrative of the present invention, and the content of the present invention is not limited thereto.

EXAMPLE 1

Preparation of Sarcodon aspratus Extracts

[0056] Sarcodon aspratus was harvested from a hill located in Andong, Gyeongsangbuk-do. The fruit bodies of the harvested Sarcodon aspratus were subjected to hot air drying and pulverized. Then, 3 g of the pulverized Sarcodon aspratus was added to 180 ml of water, boiled at 50° C. for 30 minutes, and then boiled at 100° C. for 10 minutes to obtain Sarcodon aspratus extracts.

<Experimental Example 1> Evaluation of Efficacy of Sarcodon aspratus Extracts in Treatment of Dysmenorrhea

[0057] The following experiments were performed to evaluate the efficacy of Sarcodon aspratus extracts in alleviating or treating dysmenorrhea.

<1-1> Subject

[0058] The efficacy of the Sarcodon aspratus extracts in alleviating or treating dysmenorrhea was evaluated in 17 women in their teens to fifties who were taking painkillers due to severe dysmenorrhea during menstruation.

<1-2> Confirmation of Efficacy of Sarcodon aspratus Extracts in Treating Dysmenorrhea Based on Symptoms that Appear Before and After Taking Sarcodon aspratus Extracts

[0059] To confirm change before and after administration of the Sarcodon aspratus extracts, women who usually took painkillers due to severe dysmenorrhea were selected, and at the onset of dysmenorrhea, the women took 160 ml of the extracts prepared according to Example 1. Changes according to extract intake are shown in Table 1 below.

TABLE-US-00001 TABLE 1 Comparison before and after taking Sarcodon aspratus extracts Amount of Color of Dysmenorrhea period Menstruation menstrual menstrual Extravasated Menstrual Immediately period blood blood blood irregularity No. Before after Before After After After After Before After 1 2 days None 5 days 3 days Decrease Clear Disappeared Yes No 2 2 days None 7 days 5 days Decrease Clear Disappeared No No 3 1 day None 7 days 5 days Decrease Clear Disappeared No No 4 2 days None 5 days 5 days No change Clear Disappeared No No 5 4 days None 7 days 6 days Decrease Clear Decreased No No 6 3 days None 6 days 4 days Decrease Clear Disappeared No No 7 3 days None 5 days 5 days Decrease No change Disappeared No No 8 2 days None 6 days 5 days No change Clear Disappeared No No 9 2 days None 5 days 5 days Decrease Clear Disappeared No No 10 2 days None 5 days 5 days No change Clear Disappeared No No 11 4 days None 6 days 6 days Decrease Clear Disappeared No No 12 2 days None 5 days 3 days Decrease Clear Disappeared Yes No 13 3 days None 5 days 5 days Decrease Clear Decreased No No 14 1 day None 6 days 4 days Decrease Clear Disappeared No No 15 2 days None 7 days 5 days No change Clear Decreased No No 16 3 days None 7 days 5 days No change No change Disappeared No No 17 2 days None 6 days 4 days Decrease Clear Disappeared Yes No

[0060] As shown in Table 1, immediately after taking the Sarcodon aspratus extracts, dysmenorrhea disappeared in all women who took the Sarcodon aspratus extracts. In most women, during the month of taking the Sarcodon aspratus extracts once, the menstruation period and the amount of menstrual blood decreased, the color of menstrual blood became clear, and extravasated blood and menstrual irregularity disappeared (Table 1). In addition, in some women, depression, fatigue, and edema due to menstruation decreased.

<1-3> Evaluation of Efficacy of Sarcodon aspratus Extracts in Treatment of Dysmenorrhea After Single Dose

[0061] After taking Sarcodon aspratus extracts once, changes after 1, 2, 3, 6, and 12 months were examined, and the results are shown in Tables 2 to 4 below.

TABLE-US-00002 TABLE 2 Comparison of dysmenorrhea period Dysmenorrhea period No. 1 month 2 months 3 months 6 months 12 months 1 None None None None None 2 5 minutes None None None Unaware 3 None None None None None 4 None None None None None 5 Insignificant None None Unaware Unaware pain 6 None None None None None 7 None None None None None 8 None None None None None 9 None None None None None 10 None None None None None 11 None None None None None 12 None None None Unaware Unaware 13 None None None None None 14 None None None None None 15 None None None None None 16 None None None None None 17 None None None None None

TABLE-US-00003 TABLE 3 Comparison of amount of menstrual blood Amount of menstrual blood No. 1 month 2 months 3 months 6 months 12 months 1 Decrease Decrease Decrease Decrease Decrease 2 Decrease Decrease Decrease Decrease Unaware 3 Decrease Decrease Decrease Decrease Decrease 4 No change No change No change No change No change 5 Decrease Decrease Decrease Unaware Unaware 6 Decrease Decrease Decrease Decrease Decrease 7 Decrease Decrease Decrease Decrease Decrease 8 No change Decrease Decrease Decrease Decrease 9 Decrease Decrease Decrease Decrease Decrease 10 No change No change No change No change No change 11 Decrease Decrease Decrease Decrease Decrease 12 Decrease Decrease Decrease Unaware Unaware 13 Decrease Decrease Decrease Decrease Decrease 14 Decrease Decrease Decrease Decrease Decrease 15 No change No change No change No change No change 16 No change No change No change No change No change 17 Decrease Decrease Decrease Decrease Decrease

TABLE-US-00004 TABLE 4 Comparison of generation of extravasated blood Extravasated blood No. 1 month 2 months 3 months 6 months 12 months 1 Disappeared Disappeared Disappeared Disappeared Disappeared 2 Disappeared Disappeared Disappeared Disappeared Unaware 3 Disappeared Disappeared Disappeared Disappeared Disappeared 4 Disappeared Disappeared Disappeared Disappeared Disappeared 5 Decreased Decreased Disappeared Unaware Unaware 6 Disappeared Disappeared Disappeared Disappeared Disappeared 7 Disappeared Disappeared Disappeared Disappeared Disappeared 8 Disappeared Disappeared Disappeared Disappeared Disappeared 9 Disappeared Disappeared Disappeared Disappeared Disappeared 10 Disappeared Disappeared Disappeared Disappeared Disappeared 11 Disappeared Disappeared Disappeared Disappeared Disappeared 12 Disappeared Disappeared Disappeared Unaware Unaware 13 Decreased Decreased Disappeared Disappeared Disappeared 14 Disappeared Disappeared Disappeared Disappeared Disappeared 15 Decreased Decreased Decreased Disappeared Disappeared 16 Disappeared Disappeared Disappeared Disappeared Disappeared 17 Disappeared Disappeared Disappeared Disappeared Disappeared

[0062] As shown in Tables 2 to 4, after taking the Sarcodon aspratus extracts once, dysmenorrhea was insignificant or absent even when no additional Sarcodon aspratus extracts were taken. In addition, the amount of menstrual blood was decreased, and extravasated blood disappeared. The efficacy lasted even after 12 months (Tables 2 to 4).

[0063] Meanwhile, the Sarcodon aspratus extracts according to the present invention may be formulated in various forms according to purpose. Several formulation methods of containing the Sarcodon aspratus extracts according to the present invention as active ingredients are described below, but the present invention is not limited thereto.

<Formulation Example 1> Preparation of Pharmaceutical Formulation

<1-1> Preparation of Powders

[0064] 2 g of the Sarcodon aspratus extracts according to the present invention; and

[0065] 1 g of lactose.

[0066] These components are mixed, a sealable bag is filled with the mixed components, and powders are prepared.

<1-2> Preparation of Tablets

[0067] 100 mg of the Sarcodon aspratus extracts according to the present invention;

[0068] 100 mg of corn starch;

[0069] 100 mg of lactose; and

[0070] 2 mg of magnesium stearate.

[0071] These components are mixed, and tablets are prepared by performing tableting according to a conventional method of preparing tablets.

<1-3> Preparation of Capsules

[0072] 100 mg of the Sarcodon aspratus extracts according to the present invention;

[0073] 100 mg of corn starch,

[0074] 100 mg of lactose; and

[0075] 2 mg of magnesium stearate.

[0076] These components are mixed, and capsules are prepared by filling capsules with gelatin according to a conventional method of preparing capsules.

<1-4> Preparation of Pills

[0077] 1 g of the Sarcodon aspratus extracts according to the present invention;

[0078] 1.5 g of lactose;

[0079] 1 g glycerin; and

[0080] 0.5 g of xylitol.

[0081] These components are mixed, and according to a conventional method, pills are prepared so that the weight of a pill is 4 g.

<1-5> Preparation of Granules

[0082] 150 mg of the Sarcodon aspratus extracts according to the present invention;

[0083] 50 mg of soybean extracts;

[0084] 200 mg of glucose; and

[0085] 600 mg of starch.

These components are mixed, 100 mg of 30% ethanol is added to the mixture, drying is performed at 60° C. to form granules, and bags are filled with the granules.

<1-6> Preparation of Injections

[0086] 500 mg of the Sarcodon aspratus extracts according to the present invention;

[0087] an appropriate amount of sterile distilled water for injection; and

[0088] an appropriate amount of pH regulator;

[0089] These components are mixed, and according to a conventional method of preparing injections, injections are prepared so that one ampoule (2 ml) contains the components according to the contents.

<1-7> Preparation of Liquid Formulation

[0090] 100 mg of the Sarcodon aspratus extracts according to the present invention;

[0091] 10 g of isomerized sugar;

[0092] 5 g of mannitol; and

[0093] an appropriate amount of purified water.

[0094] According to a conventional method of preparing liquid formulations, each component is dissolved in purified water, lemon flavor is added thereto, mixing is performed, purified water is added thereto to adjust the total volume to 100 ml, a brown bottle is filled with the mixture, and sterilization is performed to prepare a liquid formulation.

<Formulation Example 2> Preparation of Functional Health Food

[0095] 100 mg of the Sarcodon aspratus extracts according to the present invention;

[0096] an appropriate amount of a vitamin mixture;

[0097] 70 μg of vitamin A acetate;

[0098] 1.0 mg of vitamin E;

[0099] 0.13 mg of vitamin B1;

[0100] 0.15 mg of vitamin B2;

[0101] 0.5 mg of vitamin B6;

[0102] 0.2 μg of vitamin B12;

[0103] 10 mg of vitamin C;

[0104] 10 μg of biotin;

[0105] 1.7 mg of nicotinic acid amide;

[0106] 50 μg of folate;

[0107] 0.5 mg of calcium pantothenate;

[0108] an appropriate amount of a mineral mixture;

[0109] 1.75 mg of ferrous sulfide;

[0110] 0.82 mg of zinc oxide;

[0111] 25.3 mg of magnesium carbonate;

[0112] 15 mg of potassium phosphate monobasic;

[0113] 55 mg of dicalcium phosphate;

[0114] 90 mg of potassium citrate;

[0115] 100 mg of calcium carbonate; and

[0116] 24.8 mg of magnesium chloride.

[0117] The composition ratio of the vitamins and the mineral mixture described above may be determined according to a composition ratio used in general functional health foods, and the combination ratio of the vitamins and the mineral mixture may be arbitrarily determined. According to a conventional method of preparing functional health foods, these components are mixed, granules are prepared, and the granules are used to prepare a composition for a functional health food.