JP6961200B2 - Menopausal indefinite complaint relief agent - Google Patents

Description

The present invention relates to a menopausal indefinite complaint relieving agent that alleviates various symptoms of menopausal indefinite complaints.

During menopause, with a decrease in female hormones, unpleasant symptoms such as general malaise, fatigue, slight fever, heavy headache, headache, hot flashes, ringing in the ears, numbness, palpitation, and cold limbs, that is, indefinite complaints It is known to cause symptoms and affect daily life. Such symptoms of indefinite complaints during menopause are thought to be due to decreased secretion of female hormones (estrogens, etc.), and even in young women, hormone balance due to excessive stress associated with social advancement, diet, etc. Is known to collapse and exhibit symptoms similar to indefinite complaints.

Female hormone replacement therapy (HRT), which is used to improve menopausal indefinite complaints, is based on the idea of artificially supplementing the deficient female hormones. This HRT is effective not only for menopause and osteoporosis, but also for improving the skin condition associated with decreased secretion of female hormones, but it has been pointed out that there is a risk that the incidence of breast cancer and endometrial cancer will increase. ing. Therefore, it is known to ingest isoflavone contained in soybean as an alternative therapy to HRT for menopausal disorders (see, for example, Patent Document 1). Further, Patent Document 2 discloses a composition for healing menopausal disorders, which contains Jatropha macrantha, which is a crude drug plant native to the Andes, and / or an extract thereof. Further, Patent Document 3 is characterized by containing at least one selected from the group consisting of fennel, Ogon, Coptis chinensis, Coptis chinensis, Goshuyu, Soujutsu, Soyo, Tohi, Clove, Yokuinin and Ryokyo. Prophylactic or therapeutic composition is disclosed.

Japanese Unexamined Patent Publication No. 2003-2831 Japanese Unexamined Patent Publication No. 2003-321383 Japanese Unexamined Patent Publication No. 2005-298450

An object of the present invention is to provide a menopausal indefinite complaint relieving agent for alleviating various symptoms of menopausal indefinite complaints.

The climacteric indefinite complaint relieving agent of the present invention is characterized by containing a fermentation composition obtained by inoculating a medium containing rice bran and soybeans with Bacillus natto and fermenting the rice bran and soybeans. ..

According to the menopausal indefinite complaint relieving agent of the present invention, various symptoms of menopausal indefinite complaint can be alleviated.

It is a graph which shows the transition of the vasomotor neuropathy-like symptom before and after ingestion of the menopausal indefinite complaint relieving agent of Example 1. It is a graph which shows the transition of the sensory disorder-like symptom before and after ingestion of the menopausal indefinite complaint relieving agent of Example 1. It is a graph which shows the transition of the insomnia symptom before and after ingestion of the menopausal indefinite complaint relieving agent of Example 1. It is a graph which shows the transition of the nervous symptom before and after ingestion of the menopausal indefinite complaint relieving agent of Example 1. It is a graph which shows the transition of the depressive symptom before and after ingestion of the menopausal indefinite complaint relieving agent of Example 1. It is a graph which shows the transition of the dizziness symptom before and after ingestion of the menopausal indefinite complaint relieving agent of Example 1. It is a graph which shows the transition of the general malaise symptom before and after ingestion of the menopausal indefinite complaint relieving agent of Example 1. It is a graph which shows the transition of the arthralgia / myalgia symptom before and after ingestion of the menopausal indefinite complaint relieving agent of Example 1. It is a graph which shows the transition of the headache symptom before and after ingestion of the menopausal indefinite complaint relieving agent of Example 1. It is a graph which shows the transition of the palpitations hyperthermia before and after ingestion of the menopausal indefinite complaint relieving agent of Example 1. It is a graph which shows the transition of the formication symptom before and after ingestion of the menopausal indefinite complaint relieving agent of Example 1. Changes in the total of vasomotor neuropathy-like symptoms, sensory disorder-like symptoms, insomnia, nervousness, depression, dizziness, general malaise, arthralgia / myalgia, and formication before and after ingestion of the menopausal indefinite complaint relieving agent of Example 1. It is a graph which shows.

The fermentation composition contained in the menopausal indefinite complaint alleviating agent of the present invention includes a natto bacterium inoculation step of inoculating a medium containing rice bran and soybeans with natto bacteria, and a fermentation step of fermenting rice bran and soybeans. It was obtained by the method. Since the active ingredient of the fermentation composition is a water-soluble solid, the menopausal indefinite complaint alleviating agent of the present invention may be a solid composition containing the active ingredient, and the active ingredient and the like may be contained in a liquid described later. It may be a dissolved or dispersed liquid composition.

The medium used in the natto bacterium inoculation step may be either a liquid medium or a solid medium as long as it contains rice bran and soybeans and can cultivate natto bacteria (Bacillus subtilis). In the present invention, a liquid medium containing rice bran, soybeans, and water is preferable because the active ingredient can be efficiently recovered. The medium preferably further contains other nutrients such as a carbon source, a nitrogen source, a phosphorus source, and a vitamin source, which will be described later, and in the case of a liquid medium, it preferably contains an antifoaming agent and the like.

Examples of rice bran include rice bran, rice germ, defatted rice germ, defatted rice bran, rice bran extract and the like. These can be used alone or in combination of two or more.
Examples of soybeans include raw soybeans, dried soybeans, defatted soybeans, kina flour, soybean flour, soybean residue, soybean extract, soybean protein, soybean peptides, and hydrolyzates thereof. These may be used alone or in combination of two or more.

The mass ratio of rice bran and soybeans contained in the medium is as follows because fermentation using Bacillus natto can be efficiently promoted and a fermentation composition suitable for promoting the production of collagen or hyaluronic acid can be obtained. be. That is, when rice bran is 100 parts by mass, soybeans are preferably 10 to 1000 parts by mass, more preferably 20 to 500 parts by mass, and further preferably 50 to 200 parts by mass.

Examples of carbon sources include monosaccharides such as ribose, arabinose, xylose, glucose, fructose, mannose, galactose, and lambrose; disaccharides such as sucrose, maltose, lactose, trehalose, and cellobiose; trisaccharides such as raffinose and maltotriose; starch. , Polysaccharides such as dextrin. These may be used alone or in combination of two or more.

When using a carbon source, the amount used is preferably 10 to 1000 parts by mass, more preferably 20 to 500 parts by mass, when 100 parts by mass of rice bran is used because fermentation using Bacillus natto can proceed efficiently. Parts, more preferably 50 to 200 parts by mass.

Amino acids such as arginine, glycine, glutamine, glutamic acid, tryptophan, lysine, methionine, phenylalanine, threonine, valine, isoleucine, leucine, histidine, alanine, asparagine, serine, aspartic acid, cysteine, proline, tyrosine; , Nitrate such as sodium nitrate and calcium nitrate; ammonium salt such as ammonium sulfate and ammonium chloride; urea and the like. These may be used alone or in combination of two or more. In the present invention, amino acids such as arginine are preferable.

When using a nitrogen source, the amount used is preferably 10 to 1000 parts by mass, more preferably 20 to 500 parts by mass, when 100 parts by mass of rice bran is used because fermentation using Bacillus natto can proceed efficiently. Parts, more preferably 50 to 200 parts by mass.

Examples of the phosphorus source include phytic acid or a salt thereof (hereinafter, these are collectively referred to as "phytic acids"), phosphates such as potassium monohydrogen phosphate, potassium dihydrogen phosphate, and ammonium phosphate. These may be used alone or in combination of two or more. In the present invention, phytic acids are preferable.

The phytic acids may be artificially obtained or may be derived from a natural product (plant or the like).
As the salt of phytic acid, a non-toxic salt is used, and a salt with a metal, an organic base, a basic amino acid, an organic ester residue and the like is preferable. For example, salts such as potassium, sodium, arginine, ornithine, lysine, histidine, glucamine, monoethanolamine and the like can be used.

When using a phosphorus source, the amount used is preferably 10 to 1000 parts by mass, more preferably 20 to 500 parts by mass, when 100 parts by mass of rice bran is used because fermentation using Bacillus natto can proceed efficiently. Parts, more preferably 50 to 200 parts by mass.

Examples of vitamins include vitamin B1, vitamin B6, vitamin B12, nicotinic acid, nicotinamide, inositol, myoinositol, vitamin K and the like. These may be used alone or in combination of two or more.

The amount of vitamins used is preferably 0.1 to 50 parts by mass, more preferably 1 to 50 parts by mass, when 100 parts by mass of rice bran is used, because fermentation using Bacillus natto can proceed efficiently. It is 10 parts by mass.

In the present invention, when a liquid medium is used, as described above, the preferred medium is water, and the concentration of rice bran is preferably 0.1 to 20% by mass, more preferably 0.5 to 10% by mass. Is used as such.

In the present invention, when a liquid medium is used, it is preferable to add an antifoaming agent for suppressing foaming in the fermentation step.

Examples of the defoaming agent include oil and fat defoaming agents for animal and vegetable oils such as castor oil, sesame oil, flaxseed oil, and soybean oil; fatty acid defoaming agents such as stearic acid, oleic acid, and palmitic acid; isoamyl stearate, diglycol laurin. Acid, disteryl succinic acid, ethylene glycol, distearic acid, sorbitan monolauric acid, polyoxyethylene sorbitan, monolaurate butyl stearate, sulfonated lithinolic acid ethyl acetate alkyl ester, natural wax and other fatty acid ester defoamers; polyoxyalkylene Alcohol-based defoamers such as glycol and its derivatives, polyoxyalkylene alcohol monohydrate, 3-tert-amylphenoxyethanol, 3-heptanol, 2-ethylhexanol; di-tert-amylphenoxyethanol, 3-heptyl cellosolve, nonyl Ether-based defoamers such as cellosolve-3-heptyl carbitol; amine-based defoamers such as diamilamine; amide defoamers such as polyalkylene amide, acylate polyamine, and dioctadecanoyl piperidin; Al-stearic acid, Metal soap defoamers such as Ca-stearic acid, K-oleic acid, Ca salt of wool olein; silicone-based defoamers such as dimethylpolysiloxane, silicone paste, silicone emulsion, silicone-treated powder, organically modified polysiloxane, fluorosilicone, etc. Examples include foaming agents. These may be used alone or in combination of two or more. In the present invention, a fatty acid ester antifoaming agent is preferable.

When an antifoaming agent is used for preparing the liquid medium, the concentration of the antifoaming agent is preferably 0.01 to 1% by mass, more preferably 0.05 to 0.5% by mass. ..

In the fermentation step, the PH of the medium inoculated with Bacillus natto (medium containing Bacillus natto) is preferably 6.5 to 10, more preferably 7.0 to 9.0, and is therefore used in the step of inoculating Bacillus natto. The medium (before inoculation of Bacillus natto) is preferably adjusted to a pH within the above range in advance, and is exemplified below.

As the PH adjuster, a base such as potassium hydroxide, sodium hydroxide, potassium carbonate or sodium hydrogencarbonate, or an acid such as citric acid, gluconic acid, succinic acid, lactic acid or carbon dioxide is used. These components can be used as they are or as an aqueous solution.

The natto bacterium used in the natto bacterium inoculation step is not particularly limited as long as it is a bacterium of the genus Bacillus, and may be a commercially available product (Takahashi bacterium, Naruse bacterium, Asahi bacterium, Nitto bacterium, Meguro bacterium, Miyagino bacterium, etc.). However, it may be a mutant strain obtained by artificial mutation means by a chemical substance such as nitrosoguanidine, X-ray, ultraviolet rays, etc., and whose mycological properties have been mutated. The natto bacterium used may be only one kind or two or more kinds.

Bacillus natto, but are not limited to, the number of bacteria in the culture medium is inoculated preferably such that ¹⁰ 5 ^{to 10 10} cells / mL, more preferably ¹⁰ 7 to 10 ⁸ / mL.
When inoculating Bacillus natto, other bacteria or yeast may be used in combination. In addition, when inoculating Bacillus natto, it is preferable to sterilize the medium in advance. The sterilization method is not particularly limited, but it is preferable to perform heat treatment at 90 ° C. to 130 ° C. for 10 to 30 minutes, for example.

Next, by subjecting a medium inoculated with Bacillus natto (hereinafter referred to as "medium containing Bacillus natto") under predetermined conditions, natto bacteria are cultured and rice bran and soybeans are fermented (fermentation). Process). The treatment temperature in this fermentation step is preferably 30 ° C. to 45 ° C., more preferably 35 ° C. to 40 ° C. The treatment time is preferably 6 to 48 hours, more preferably 12 to 30 hours.

In the fermentation step, it is preferable to proceed with stirring the medium containing Bacillus natto. Then, after being subjected to the treatment for a predetermined time, the fermentation step can be completed by setting the pH of the Bacillus natto-containing medium to 6 or less, preferably 5 or less, and more preferably 1 to 4. When adjusting the pH, citric acid, gluconic acid, succinic acid, lactic acid, carbon dioxide and the like can be used.
The cultured fermented product (the medium containing Bacillus natto after the fermentation step) obtained by this fermentation step contains a raw material or a modified raw material used for preparing the medium in addition to the fermentation composition according to the present invention. Therefore, when the medium is a liquid medium using water, the fermentation composition dissolved in water can be recovered by performing solid-liquid separation. When the medium is a solid medium, the fermentation composition can be extracted with water from the cultured fermented product, and the fermentation composition can be recovered in the same manner. Then, if necessary, a concentrated fermentation composition (liquid fermented product) or freeze-drying, spray-drying, etc. is performed to obtain a dry solid product (solid fermented product) from which water has been distilled off. Can be done. This dry matter is substantially the active ingredient in the present invention.

In the present invention, the content ratio of the active ingredient is appropriately selected depending on the properties of the menopausal indefinite complaint relieving agent, but when the menopausal indefinite complaint relieving agent is a solid composition, it is preferably 0.0001 to 100% by mass. It is more preferably 0.01 to 50% by mass, still more preferably 0.1 to 20% by mass. When the menopausal indefinite complaint relieving agent is a liquid composition, it is preferably 0.0001 to 50% by mass, more preferably 0.01 to 25% by mass, and further preferably 0.1 to 10% by mass.

The menopausal indefinite complaint relieving agent of the present invention may contain other nutritional components, medicinal properties, seasoning components, odor components and the like.

When the menopausal indefinite complaint relieving agent of the present invention is a solid composition, it may be in the form of powder, in the form of encapsulating powder, or, if necessary, dextrin, starch, pregelatinized starch, polyvinylpyrrolidone, ethyl cellulose. , Methyl cellulose, microcrystalline cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose and the like, and can be used for compression molding and the like.
In addition, when the menopausal indefinite complaint relieving agent of the present invention is a liquid composition, it can be in a liquid state, in a capsule-encapsulated manner, or the like. Examples of the medium include water, alcohol (ethanol, etc.) and the like.

The amount (intake) of the menopausal indefinite complaint relieving agent of the present invention is appropriately selected depending on the age, sex, degree of disease, etc. of the ingestor, but is ingested by one adult in daily eating habits. In the case of the above, it is preferably 0.001 to 20 g, more preferably 0.01 to 5 g, and further preferably 0.05 to 1 g per day in terms of the active ingredient. In addition, it may be taken once a day or divided into several times. When the amount used is within the above range, for example, when the indefinite complaint relieving agent for menopause is continued for 8 weeks or more, vasomotor neuropathy-like symptoms, sensory disorder-like symptoms, insomnia symptoms, nervous symptoms, depression symptoms , Dazzling symptom, general malaise symptom, joint pain / muscular pain symptom, headache symptom, heart attack symptom, ant running sensation symptom and other symptoms of indefinite menopausal complaint can be alleviated.

Hereinafter, the present invention will be described in more detail with reference to examples, but the present invention is not limited to such examples as long as the gist of the present invention is not exceeded. In addition, "part" and "%" are based on mass unless otherwise specified.

Example 1 (Manufacturing and evaluation of menopausal indefinite complaint palliative)
Defoaming agent 0.1 consisting of 1.8 parts of rice bran extract, 1.8 parts of soy protein, 1.8 parts of phytic acid, 1.8 parts of glucose, 1.8 parts of arginine and glycerin fatty acid ester in about 80 parts of water. After adding the parts and mixing thoroughly, the PH of the mixed solution was adjusted to 8.0 using potassium hydroxide. Then, water was added so that the total amount was 100 parts, and a medium was prepared.
The medium was then sterilized at 121 ° C. for 20 minutes using an autoclave. Then, the medium was cooled to 37 ° C., and Bacillus natto was inoculated therein, and the culture of Bacillus natto and the fermentation of rice bran extract and soybean protein were started. At this time, ventilation was not performed. Eighteen hours after the inoculation of Bacillus natto, citric acid used in 3 parts was added to the fermented product with respect to 100 parts of the medium to adjust the pH to 3.4.
The fermented product was then sterilized at 121 ° C. for 20 minutes using an autoclave. Then, the fermented product is cooled to room temperature (about 20 ° C.) and centrifuged (rotation speed: 5000 rPm, time: 15 minutes) using a Tomy Seiko centrifuge "GRX-250" (model name). Served. Then, the supernatant was collected and filtered (using # 1 filter paper) to obtain a fermented product of a brown liquid (solid content concentration of the menopausal indefinite complaint relieving agent: 12%). Then, 48 parts of starch was added as a binder to the fermented product of this brown liquid, and the mixture was sufficiently stirred, and then water was distilled off using a spray dryer to obtain 60 parts of a dry solid product.
Next, 165 mg of this dry matter (containing 33 mg of the active ingredient of the menopausal indefinite complaint relieving agent) was encapsulated in a hard capsule consisting of 63 mg of gelatin and 2.25 mg of caramel color to obtain a capsule.

13 women aged 40 to 55 who are aware of indefinite menopausal complaints and have high scores on the Kupperman Menopause Index Questionnaire (exclusion criteria: pregnant or potentially pregnant, and lactating) Persons taking drugs (hormonal agents) that may affect the test results; Health foods that may affect the test results (proclaiming the effect of improving menopausal indefinite complaints) Those who take on a daily basis; those who are alcoholic; those who may show allergic symptoms due to taking capsules; those who participate in other clinical trials; those who have serious liver damage, menopause, A person with a history of heart disease; a person with a history of hepatitis, a person with a current illness; a person with severe anemia) was asked to take 3 capsules of the above capsule daily with water before going to bed. The symptoms were evaluated by the Kupperman Menopause Index Questionnaire after 8 weeks and 4 weeks after continuing for 8 weeks while maintaining the same living environment (sleep, meal time, general life) as before the start. Table 1 shows the nutritional components per menopausal indefinite complaint relieving agent (495 mg) taken daily.

Symptoms on the Kupperman Menopause Index Questionnaire are (1) vasomotor palpitations-like symptoms, (2) sensory dysfunction-like symptoms, (3) sleeplessness, (4) nervousness, (5) depression, (6) dizziness, (7). General malaise, (8) joint pain / muscle pain, (9) headache, (10) palpitations, and (11) formication were obtained, and the following results were obtained.

(1) Vascular motor neuropathy-like symptoms 10.5 (mean value) ± 2.0 (standard deviation) before ingestion, 8.00 (average value) ± 4.00 (standard deviation) 4 weeks after ingestion, ingestion After 8 weeks, it was 6.15 (mean) ± 3.51 (standard deviation). Compared with before ingestion, it was -2.50 after 4 weeks of ingestion and -4.35 after 8 weeks of ingestion, 4 weeks after ingestion (P = 0.033), and 8 weeks after ingestion (P = 0. A significant difference was observed in 004) (see Table 2 and FIG. 1).
(2) Sensory disorder-like symptoms 2.92 (mean value) ± 1.93 (standard deviation) before ingestion, 1.69 (average value) ± 1.80 (standard deviation) 4 weeks after ingestion, 8 weeks ingestion Later, it was 0.769 (mean) ± 1.739 (standard deviation). Compared with before ingestion, it was -1.23 after 4 weeks of ingestion and -2.151 after 8 weeks of ingestion, 4 weeks after ingestion (P = 0.033), and 8 weeks after ingestion (P = 0. A significant difference was observed in 009) (see Table 2 and FIG. 2).
(3) Insomnia 5.38 (mean) ± 0.96 (standard deviation) before ingestion, 3.23 (mean) ± 2.24 (standard deviation) 4 weeks after ingestion, 2 after 8 weeks ingestion It was .77 (mean value) ± 1.54 (standard deviation). Compared with before ingestion, it was -2.15 after 4 weeks of ingestion and -2.61 after 8 weeks of ingestion, 4 weeks after ingestion (P = 0.010), and 8 weeks after ingestion (P = 0. A significant difference was observed in 004) (see Table 2 and FIG. 3).
(4) Nervousness 4.77 (mean value) ± 1.30 (standard deviation) before ingestion, 3.08 (average value) ± 1.55 (standard deviation) 4 weeks after ingestion, 2 after 8 weeks ingestion It was .92 (mean value) ± 1.75 (standard deviation). Compared with before ingestion, it was -1.69 after 4 weeks of ingestion and -1.85 after 8 weeks of ingestion, 4 weeks after ingestion (P = 0.013), and 8 weeks after ingestion (P = 0. A significant difference was observed in 012) (see Table 2 and FIG. 4).
(5) Depression 2.46 (mean) ± 0.78 (standard deviation) before ingestion, 1.54 (mean) ± 1.13 (standard deviation) 4 weeks after ingestion, 1 after 8 weeks ingestion It was .31 (mean value) ± 1.25 (standard deviation). Compared with before ingestion, it was -0.92 after 4 weeks of ingestion and -1.15 after 8 weeks of ingestion, 4 weeks after ingestion (P <0.010), and 8 weeks after ingestion (P = 0. A significant difference was observed in 004) (see Table 2 and FIG. 5).
(6) Dazzle 1.00 (mean value) ± 0.58 (standard deviation) before ingestion, 0.385 (average value) ± 0.506 (standard deviation) 4 weeks after ingestion, 0 after 8 weeks ingestion It was .231 (mean value) ± 0.439 (standard deviation). Compared with before ingestion, it was -0.615 after 4 weeks of ingestion and -0.769 after 8 weeks of ingestion, 4 weeks after ingestion (P = 0.005), and 8 weeks after ingestion (P = 0. A significant difference was observed in 002) (see Table 2 and FIG. 6).
(7) General malaise 2.77 (mean) ± 0.60 (standard deviation) before ingestion, 1.85 (mean) ± 0.80 (standard deviation) 4 weeks after ingestion, 8 weeks after ingestion It was 1.62 (mean value) ± 0.77 (standard deviation). Compared with before ingestion, it was -0.92 after 4 weeks of ingestion and -1.15 after 8 weeks of ingestion, 4 weeks after ingestion (P = 0.006), and 8 weeks after ingestion (P = 0. A significant difference was observed in 002) (see Table 2 and FIG. 7).
(8) Arthralgia / muscle pain 2.62 (mean value) ± 0.51 (standard deviation) before ingestion, 1.92 (average value) ± 1.04 (standard deviation) 4 weeks after ingestion, intake 8 After a week, it was 1.62 (mean) ± 1.04 (standard deviation). Compared with before ingestion, it was -0.70 after 4 weeks of ingestion and -1.00 after 8 weeks of ingestion, 4 weeks after ingestion (P = 0.034), and 8 weeks after ingestion (P = 0. A significant difference was observed in 016) (see Table 2 and FIG. 8).
(9) Headache 1.85 (mean value) ± 0.80 (standard deviation) before ingestion, 1.54 (average value) ± 1.20 (standard deviation) 4 weeks after ingestion, 1 after 8 weeks ingestion It was .08 (mean value) ± 1.12 (standard deviation). Compared with before ingestion, it was -0.31 after 4 weeks of ingestion and -0.77 after 8 weeks of ingestion, and a significant difference was observed after 8 weeks of ingestion (P = 0.019) (Table 2). And FIG. 9).
(10) Increased heartbeat 0.923 (mean) ± 0.494 (standard deviation) before ingestion, 0.538 (mean) ± 0.877 (standard deviation) 4 weeks after ingestion, 8 weeks after ingestion It was 0.308 (mean value) ± 0.630 (standard deviation). Compared with before ingestion, it was -0.385 after 4 weeks of ingestion and -0.615 after 8 weeks of ingestion, and a significant difference was observed after 8 weeks of ingestion (P = 0.005) (Table 2). And FIG. 10).
(11) Formication 1.15 (mean value) ± 1.07 (standard deviation) before ingestion, 0.385 (average value) ± 0.650 (standard deviation) 4 weeks after ingestion, 8 weeks after ingestion It was 0.154 (mean value) ± 0.555 (standard deviation). Compared with before ingestion, it was -0.765 after 4 weeks of ingestion and -0.996 after 8 weeks of ingestion, 4 weeks after ingestion (P = 0.014), and 8 weeks after ingestion (P = 0. A significant difference was observed in 016) (see Table 2 and FIG. 11).

In addition, when the total of each evaluation of the above symptoms (1) to (11) was totaled, 36.3 (mean value) ± 4.2 (standard deviation) before ingestion and 24.2 (average) 4 weeks after ingestion. Value) ± 9.1 (standard deviation), 18.9 (mean value) ± 8.1 (standard deviation) 8 weeks after ingestion. Compared with before ingestion, it was -12.1 after 4 weeks of ingestion and -17.4 after 8 weeks of ingestion, 4 weeks after ingestion (P = 0.006), and 8 weeks after ingestion (P = 0. A significant difference was observed in 002) (see Table 2 and FIG. 12).

As is clear from Table 2 and FIGS. 1 to 12, vasomotor neuropathy-like symptoms, sensory dysfunction-like symptoms, insomnia, nervousness, depression, dizziness, general malaise, arthralgia / myalgia, formication and total items It was found that 4 weeks after ingestion and 8 weeks after ingestion, the values were significantly lower than those before ingestion, and the values were alleviated over time.

Since the menopausal indefinite complaint relieving agent of the present invention can be safely used without having cytotoxicity, it can be used in the form of powders, tablets, encapsulated microcapsules, beverages, etc., and thus foods (health foods), supplements, pharmaceuticals, etc. It is useful for such purposes.

Claims (3)

A perennial indefinite complaint characterized by containing a fermentation composition obtained by inoculating a medium containing rice bran extract , soybean protein , and phytic acid or a salt thereof with Bacillus natto and fermenting the medium. Relief agent. Said rice bran extract contained in the medium, and the soy protein, the mass ratio between the phytic acid or its salts, when the rice bran extract with 100 parts by weight, the soy protein is at 10 to 1000 parts by weight The phytic acid or a salt thereof is 10 to 1000 parts by mass, according to claim 1, wherein the menopausal indefinite complaint relieving agent. A composition for alleviating menopausal indefinite complaints, which comprises the alleviating agent for indefinite menopause according to claim 1 or 2.

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