JP2005139135A - Agents for preventing and improving menopause - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medicine and a food and drink which prevent or improve symptoms of menopause and have no side effects even when taken for a long time.
An amount of γ-aminobutyric acid, or γ-aminobutyric acid, soy isoflavone and royal jelly, which can prevent or ameliorate climacteric disorder, is added and blended.
[Selection figure] None

Description

  The present invention relates to a medicine and a food containing γ-aminobutyric acid as an active ingredient for preventing or improving the symptoms of menopause. The present invention also relates to a medicine and a food containing γ-aminobutyric acid, soy isoflavone and royal jelly for preventing or improving the symptoms of menopause.

  Menopause is a symptom or disorder that can occur in the process of ovarian function beginning to decline and disappear due to the aging process and is sometimes referred to as climacteric symptoms. Menopause is a symptom caused by decreased ovarian function, environmental factors, psychological factors, etc., mainly vasomotor disorder-like symptoms, neuropsychiatric disorder-like symptoms, sensory disturbance symptoms, urogenital disorder symptoms, It is classified into motor organ disorder symptoms, skin urinary disorder symptoms, gastrointestinal disorder symptoms and other symptoms. For these symptoms, hormone replacement therapy is performed to replace hormones such as estrogen. However, there are concerns about side effects with hormone therapy. In addition, some menopause are non-estrogen-dependent, and hormonal therapy cannot be expected to improve the patient, and many patients complain of indefinite complaints with poor objective findings.

  Menopause is a time that women must experience, and the various symptoms of menopause are mentally painful for women, regardless of their strength. Under these circumstances, there is a demand for improving the quality of life (QOL) of women by preventing or improving and reducing climacteric symptoms or disorders.

  On the other hand, soy isoflavones and isoflavones extracted from other plant materials, alone or in combination with components such as saponin and phenolic acid, are used in various cancers, blood cholesterol lowering, osteoporosis, pre-menopausal symptoms (ie, menopause) It has been reported that it can be used as a nutritional supplement or a food additive for improving (see Patent Document 1). In addition, it has been proposed that soybean isoflavones can be used in combination with theanine and royal jelly to improve female hormone abnormal disorders including menopause (see Patent Document 2). However, the effect is not sufficient, and there is a demand for pharmaceuticals or foods that have a sufficient preventive / ameliorating action for menopause and are highly safe.

γ-Aminobutyric acid is a kind of amino acid that is biosynthesized from glutamic acid, and is present mainly in the brain spinal cord in animals and is a major inhibitory transmitter of nerves. Since γ-aminobutyric acid enhances the metabolic function of brain cells, it is used to improve headaches, tinnitus, memory impairment, decreased motivation, etc. due to sequelae of stroke, cerebral arteriosclerosis, and the like. In addition, it is also used for the purpose of preventing and improving hypertension, arteriosclerosis, lowering of cholesterol level, and suppressing increase in blood sugar, and a method for enriching foods and the like with γ-aminobutyric acid has been studied (see Patent Document 3). However, it has not been known at all that γ-aminobutyric acid has an excellent preventive / improving effect on climacteric disorder, and that when synergistic with soy isoflavone and royal jelly, it can exert a significant preventive / improving effect on climacteric disorder.
Japanese Patent Laid-Open No. 11-2221048 JP 2003-2831 A Japanese Patent Application No. 11-151072

  An object of the present invention is to provide a preventive / ameliorating agent for menopausal disorders and foods and beverages which are highly safe, such as preventing or reducing climacteric disorders and having no side effects even after long-term use.

  As a result of intensive studies for solving the above-mentioned problems, the present inventors have effectively prevented or improved climacteric disorder by allowing women to ingest γ-aminobutyric acid (hereinafter sometimes referred to as GABA). It has been found that by combining γ-aminobutyric acid with soy isoflavone and royal jelly, a significant improvement in the prevention of menopause can be achieved.

  That is, the present invention relates to a preventive / ameliorating agent for climacteric disorder comprising γ-aminobutyric acid as an active ingredient for preventing or improving climacteric disorder. The prevention-improving agent of the present invention contains 0.1 to 100% by mass, preferably 10 to 100% by mass of γ-aminobutyric acid. The present invention also relates to a preventive / ameliorating agent for climacteric disorders, which contains γ-aminobutyric acid, soy isoflavone and royal jelly. The preventive / ameliorating agent of the present invention contains 0.1 to 70% by mass of γ-aminobutyric acid, 1 to 50% by mass of soybean isoflavone, and 1 to 70% by mass of royal jelly.

  Moreover, this invention relates to the food-drinks for prevention or improvement of the climacteric disorder characterized by containing (gamma) -aminobutyric acid. This food or drink contains 0.1 to 100% by mass, preferably 10 to 100% by mass, of γ-aminobutyric acid. Furthermore, the present invention relates to a food or drink for preventing or ameliorating climacteric disorder, characterized by containing γ-aminobutyric acid, soy isoflavone and royal jelly. 70% by weight, 1-50% by weight of soybean isoflavone and 1-70% by weight of royal jelly are included.

  The preventive / ameliorating agent and food / beverage products of the present invention contain γ-aminobutyric acid and can be used effectively for prevention of climacteric disorder or improvement of symptoms. The range is usually from 0.1 to 100% by mass, preferably from 10 to 100% by mass. The daily intake of γ-aminobutyric acid is usually in the range of 10 to 500 mg, preferably in the range of 50 to 200 mg. If the intake amount per day is less than 10 mg, a sufficient effect for preventing and improving menopause cannot be obtained, and even if the intake amount is more than 500 mg, the effect exerted does not change much. The amount of γ-aminobutyric acid in the preventive / ameliorating agent can be appropriately determined within the above-mentioned range in consideration of the condition of the subject, the degree of symptoms to be prevented / ameliorated and the dosage form.

  Moreover, when the prevention-improving agent and food and drink of the present invention contain soybean isoflavone and royal jelly in addition to γ-aminobutyric acid, these prevention-improving agents contain 0.1-70% by mass of γ-aminobutyric acid, preferably 1 to 50% by mass, 1 to 50% by mass of soybean isoflavone, preferably 10 to 50% by mass and 1 to 70% by mass of royal jelly, preferably 10 to 70% by mass. The daily intake of γ-aminobutyric acid is as described above, but the daily intake of soy isoflavone is 1 to 500 mg, preferably 10 to 200 mg as total isoflavone. The daily intake of royal jelly is in the range of 10 mg to 3 g, preferably in the range of 100 to 1 g, in terms of raw royal jelly. If the amount of soy isoflavone and royal jelly is less than this range, a sufficient synergistic effect with γ-aminobutyric acid cannot be obtained, and even if the amount exceeds this range, the effect exerted is not much different. Moreover, since there are many intakes of these, it becomes unpreferable since it will become difficult to ingest depending on the form of medicine or food and drink.

Menopausal symptoms that are improved by the preventive / ameliorating agent of the present invention and food and drink include vasomotor neuropathy-like symptoms, heat sensation, coldness, hot flashes, heartbeat hypersensitivity, tachycardia, bradycardia, etc. Headache, dizziness, insomnia, tinnitus, fear, pressure, memory loss, etc., as perceptual disorder symptoms, numbness, hypersensitivity, paralysis, ant running, etc., urogenital system disorders, frequent urination, pain in urination As symptoms of motor organ disorders, stiff shoulders, low back pain, joint pain, spinal pain, muscle pain, sciatica, etc. As symptoms of skin urinary disorders, increased sweating, dry mouth, increased salivation, etc. Anorexia, nausea, vomiting, constipation, diarrhea, and other symptoms include fatigue and abdominal pain.

  Examples of the dosage form of the preventive / ameliorating agent of the present invention include tablets, capsules, granules, powders, syrups, suspensions, suppositories, inhalants, injections and the like. These preventive / improving agents are formulated with commonly used excipients, disintegrants, binders, lubricants, surfactants, alcohol, water, water-soluble polymers, sweeteners, corrigents, acidulants, etc. It can be added in accordance with the conventional method. The liquid preparation may be dissolved or suspended in water or other suitable medium at the time of taking. Tablets and granules may be coated by a known method. In addition, when the preventive / ameliorating agent of the present invention contains soybean isoflavone and royal jelly in addition to γ-aminobutyric acid, these three components may be included together, but may be formulated separately and taken together You may make it make it.

The preventive / ameliorating agent of the present invention includes various vitamins, taurine, glucuronic acid, glucuronolactone, theanine, capsaicin, polyphenols, catechins, xanthine derivatives, amino acids such as methionine, leucine, arginine, ginseng, deer, and cow yellow. Herbal medicines such as ground yellow, coconut, and royal jelly, and minerals such as calcium, magnesium, zinc, and iron may be appropriately blended. In addition to vitamin C (ascorbic acid), vitamin B group, vitamin E (tocopherol), vitamins that can be included include vitamins A, D, K, H, riboflavin butyrate, and the like. The vitamin B group includes vitamin B ₁ derivatives, vitamin B ₂ , vitamin B ₆ , vitamin B ₁₂ , vitamin B ₁₃ , and various vitamin B complexes such as biotin, pantothenic acid, nicotinic acid, and folic acid. .

  Furthermore, various additives used for manufacture of a pharmaceutical or food-drinks can be mix | blended with the prevention improving agent of this invention. Examples of such additives include various oils and fats such as vegetable oils and animal oils, polyhydric alcohols (eg, ethylene glycol, polyethylene glycol, propylene glycol, glycerin, sugar alcohols (eg, sorbitol, erythritol, xylitol, maltitol, mannitol). , Surfactant (for example, sorbitan fatty acid ester, glycerin fatty acid ester, sucrose fatty acid ester, etc.), purified water, excipients such as lactose, dextrin, starch, crystalline cellulose, cyclodextrin, gum arabic, agar, water-soluble Corn fiber, gelatin, xanthan gum, casein, gluten or gluten hydrolyzate, lecithin, dextrin, carmellose sodium, polyvinylpyrrolidone, other additives as stabilizer, pH adjustment , Antioxidants, sweeteners, taste components, acidulants, and the like coloring and flavoring.

  Examples of the food and drink of the present invention include all foods to which γ-aminobutyric acid, soy isoflavone and royal jelly can be added and blended. Specifically, tablets, powders, granules, tablets, capsules, chewables, drinks, liquid foods, tea drinks, soft drinks, milk drinks, butter, mayonnaise, shortening, margarine, various salad dressings, breads, noodles , Pasta, confectionery such as cookies, chocolate, candy, chewing gum and the like. The food and drink according to the present invention includes other food materials, various nutrients, various vitamins, minerals, dietary fiber, various additives such as taste ingredients, sweeteners, acidulants such as organic acids, stabilizers, and the like. , Flavor and the like can be blended and manufactured according to conventional methods.

[Production Example 1]
125 g of γ-aminobutyric acid (Pharma Gabba 20-D, manufactured by Pharma Foods Laboratories), 144 g of crystalline cellulose (manufactured by Asahi Kasei), 19 g of lactose (manufactured by DMV), and 12 g of glycerin fatty acid ester (manufactured by Riken Vitamin) are mixed together. Produced tablets of 300 mg per tablet. Each tablet contained about 25 mg of γ-aminobutyric acid.

[Production Example 2]
Take 125 g of refined wheat germ oil (Nisshin Pharma) and 20 g of glycerin fatty acid ester (Riken Vitamin), heat and dissolve at about 65 ° C., then lower to about 30 ° C., 125 g soybean isoflavone (EDM), binofenone 15 g of grape seed extract (manufactured by Tokiwa Phytochemical Laboratories) and 15 g of vitamin E (manufactured by Cognis Japan) were mixed with stirring to prepare a soy isoflavone-containing preparation. According to the usual method for producing soft capsules, about 300 mg per capsule was filled to produce soft capsules. The amount of soy isoflavone in this capsule is about 125 mg.

[Production Example 3]
170 g of royal jelly powder (BIOX) and 95 g of dried beer yeast powder (ASAHI FOOD & HEALTHCARE) are mixed uniformly and filled with 265 mg per capsule using No. 2 hard capsule (manufactured by Capsugel J). Hard capsules equivalent to 500 mg of raw royal jelly were produced.

Evaluation test

  The effect of the preventive / ameliorating agent for menopause of the present invention was evaluated by the following test. In the following test examples, the γ-aminobutyric acid-containing tablet produced in Production Example 1, the soybean isoflavone-containing soft capsule produced in Production Example 2, the royal jelly-containing hard capsule produced in Production Example 3, and these three components are not included as a control. Placebo tablets, soft capsules and hard capsules with the same appearance and color tone were used.

[Test Example 1]
In order to evaluate the effect of γ-aminobutyric acid on the prevention and improvement of climacteric disorder, the tablets of Production Example 1 were prepared by 14 women who had symptoms such as heat, hot flash, headache, low back pain, stiff shoulders, numbness, and urination as climacteric disorders (Example 1) or a placebo tablet (Comparative Example 1) was taken twice a day (two tablets at a time). Two months after the start of taking, the improvement of symptoms was evaluated according to the following evaluation criteria.
Evaluation criteria 4: Symptoms were almost improved compared to before taking 3: Symptoms remained but alleviated 2: Symptoms were alleviated 1: Symptoms remained the same as before taking

The average evaluation value for Example 1 and Comparative Example 1 is shown below.
Evaluation (average value)
Example 1 3.2
Comparative Example 1 1.6

  As a result, it was confirmed that when γ-aminobutyric acid was taken, symptoms of climacteric disorder were significantly prevented or improved as compared with placebo.

[Test Example 2]
Furthermore, the effect of the preventive / ameliorating agent of the present invention was evaluated as follows.
As menopausal disorders, 60 women who complain of multiple symptoms such as sensation of heat, hot flashes, headache, back pain, stiff shoulders, diarrhea, constipation, irritability and lethargy, numbness, pain in urination, etc. are divided into 5 groups of 12 women each. As shown in Table 1 below, the tablets produced in Production Example 1, the soy isoflavone-containing soft capsules produced in Production Example 2, the royal jelly-containing hard capsules produced in Production Example 3, and the appearance and color tone without these three components as controls The same placebo tablet, soft capsule (SC) and hard capsule (HC) were taken twice a day (1 tablet, 1 capsule each). Two months after the start of taking, the improvement of symptoms was evaluated according to the following evaluation criteria. The evaluation results are shown in Table 2.
Evaluation criteria 5: All symptoms were remarkably alleviated 4: One or more symptoms were remarkably alleviated, and other symptoms were alleviated 3: All symptoms were alleviated to some extent 2: 1 or more 1: All symptoms are the same as before taking

  From these results, in the group (Example 2) ingesting γ-aminobutyric acid, the soy isoflavone ingestion group (Comparative Example 2), the royal jelly ingestion group (Comparative Example 3), and the soy isoflavone + royal jelly (Comparative Example 4) ingestion group It was confirmed that the symptoms of menopause were significantly prevented or ameliorated compared to Further, from the results of Example 3, it was confirmed that when γ-aminobutyric acid was combined with soybean isoflavone and royal jelly, the synergistic effect further improved the prevention or improvement effect of menopause.

  According to the present invention, pharmaceuticals and foods for the prevention or treatment of climacteric disorder are provided. The medicament of the present invention can prevent or ameliorate various physical and mental symptoms of climacteric disorder and has high safety without causing side effects even when taken for a long time. In addition, the food and drink of the present invention can ingest daily amounts of γ-aminobutyric acid, or γ-aminobutyric acid, soy isoflavone and royal jelly necessary for the prevention of menopause or improvement of symptoms thereof as food and drink. . For this reason, the medicament and food of the present invention are extremely useful for improving a woman's QOL over a long period of time before and after menopause.

Claims (6)

  A preventive / ameliorating agent for climacteric disorder comprising γ-aminobutyric acid as an active ingredient for prevention or improvement of climacteric disorder   The prevention-improving agent according to claim 1, comprising soy isoflavone and royal jelly.   The prevention-improving agent according to claim 1, comprising 0.1 to 100% by mass of γ-aminobutyric acid.   The prevention-improving agent according to claim 2, comprising 0.1 to 70% by mass of γ-aminobutyric acid, 1 to 50% by mass of soybean isoflavone, and 1 to 70% by mass of royal jelly.   A food or drink comprising γ-aminobutyric acid for preventing or improving climacteric disorder. The food / beverage product of Claim 5 containing soybean isoflavone and royal jelly.