JP4824205B2 - Female hormone abnormal disorder improving agent - Google Patents

Description

【００２７】
結果：比較例１では更年期指数に変化は見られなかった。比較例２、３及び実施例１の試験終了時の更年期指数はいずれも試験開始時より減少したが、実施例１がより優れており、大豆イソフラボン及びテアニンを併用することにより効果の向上がみられた。ローヤルゼリーを配合した実施例２は、さらに更年期指数の減少がみられ、大豆イソフラボン、テアニン及びローヤルゼリーを併用することにより、さらに顕著な効果の向上がみられた。
【００２８】
【表２】

【００２９】
実験例２
方法：月経前症候群の症状を訴えている女性１００名を対象に月経前症候群改善効果の検討を行った。女性は２０名ずつ５つのグループに分け、第１グループには比較例１、第２グループには比較例２、第３グループには比較例３、第４グループには実施例１、第５グループには実施例２のカプセルを1日当たり２粒になるように２ヶ月間摂取し、試験開始時および終了時における各症状をアンケート調査した。独自に設定した評価基準に従い、その症状を点数化し、月経前症候群指数（ＰＭＳ指数）とし、試験開始時と終了時のＰＭＳ指数を比較した。アンケート内容とＰＭＳ指数の求め方を下記に示す。
【００３０】
症状は、腹部が痛む、腹部が張る、頭が痛い、肩がこる、めまいがする、食欲が増す、下痢、便秘、食物の嗜好が変化する、体がむくむ、乳房が痛んだり張る、にきびができやすい、肌が荒れる、化粧ののりが悪くなる、疲れやすい、眠くなる、おりものが増える、イライラする、怒りやすい、攻撃的になる、無気力になる、憂うつになる、弱気になる、涙もろい、気分が集中できない、能率が低下する、いつも通り仕事ができない、女性であることがいやになる、月経がいやになる、他人と口論する、家に引きこもる、一人でいたい、人付き合いが悪くなるなどの項目について、その症状に応じて程度を点数化し、症状がない場合は０、症状の自覚はあるが日常生活にはほとんど影響しない場合は１、仕事や家事のペースが落ちることがたまにあるが、がまんできる場合は２、仕事や家事のペースが落ち、がまんできないことがある場合は３、症状がひどく、仕事や家事が全く手につかない場合は４、それ以上にひどい場合は５とした。症状のあるものについてすべて点数化し、その合計をＰＭＳ指数とした。
【００３１】
結果：比較例１ではＰＭＳ指数に変化は見られなかった。比較例２、３及び実施例１の試験終了時のＰＭＳ指数はいずれも試験開始時より減少したが、実施例１がより優れており、大豆イソフラボン及びテアニンを併用することにより効果の向上がみられた。ローヤルゼリーを配合した実施例２は、さらにＰＭＳ指数の減少がみられ、大豆イソフラボン、テアニン及びローヤルゼリーを併用することにより、さらに顕著な効果の向上がみられた。
【００３２】
【表３】

【００３３】
実施例３、４及び５についても、実験例１及び２と同様に試験したところ、優れた更年期障害改善及び月経前症候群改善が認められた。
【００３４】
以上、実施例１〜５及び比較例１〜３の更年期障害改善及び月経前症候群改善試験結果より、大豆イソフラボン及びテアニンを含有する女性ホルモン異常障害改善剤は、優れた効果を有することが明らかとなった。さらに、大豆イソフラボン、テアニン及びローヤルゼリーを組み合わせることにより、さらに優れた効果を有することが明らかとなった。[0001]
[Industrial application fields]
The present invention relates to a female hormone abnormal disorder ameliorating agent characterized by containing soy isoflavone and theanine.
[0002]
[Prior art]
Female hormone abnormalities include climacteric disorders, premenstrual syndrome, dysmenorrhea, premenstrual tension, etc., and disorders caused mainly by rapid decrease and imbalance of female hormones associated with menstruation or menopause. That means.
[0003]
Menopause is mainly associated with menopause and before and after, and is accompanied by unpleasant complaints called indefinite complaints, which are thought to be caused by a decrease in female hormones and an imbalance in female hormones. Specific symptoms include hot flashes, hot head, painful head, heavy head, scorching, dizziness, stiff shoulders, difficulty falling asleep at night, stomach upset, close urine, easy to get tired , Limbs cold, palpitation, sweaty, limbs numbness, abdominal pain, lower back pain, limbs hurt, body swelling and other physical symptoms, irritation, lethargy, anxiety Mental symptoms such as becoming, depressed, angry, tearing, social symptoms such as not wanting to meet people, staying at home, ranting to family and friends, unable to concentrate on work But women are seriously worried about their symptoms.
[0004]
Premenstrual syndrome is an unpleasant symptom peculiar to women appearing 2 weeks to 3 days before menstruation, which is thought to be caused by imbalance of female hormones, stress, and eating habits, but the details are still unknown. There is no current situation. Specific symptoms are similar to those of menopause, but there are also symptoms such as breast enlargement and breast pain. In Japan, there is still a low awareness of premenstrual syndrome, and many women suffer from suffering alone. The treatment of these female hormone abnormalities such as menopause and premenstrual syndrome includes administration of hormonal agents, administration of tranquilizers, administration of diuretics, but all of these treatments have side effects and treatment Not as appropriate. In addition, there are psychotherapy, exercise therapy, stress relief, etc., but there is no effective treatment method for all symptoms, so it is hoped to develop a safe and highly effective agent for improving female hormone abnormal disorders. It is rare.
[0005]
[Problems to be solved by the invention]
Conventionally, it is said that soy isoflavone alone has an effect of improving menopause, but the effect is not sufficient. In addition, theanine has been reported to have a relaxing effect and an improvement effect on premenstrual syndrome alone, but there is no report on menopause. In view of such circumstances, the present inventors have studied to obtain a better female hormone abnormality disorder-improving agent, and as a result, have found that a remarkable effect is exhibited by combining soy isoflavone and theanine. Furthermore, it has been found that by combining soy isoflavone, theanine and royal jelly, a very remarkable effect is exhibited, and the present invention has been completed based on this finding.
[0006]
[Means for Solving the Problems]
That is, this invention is a female hormone abnormal disorder improving agent characterized by containing soybean isoflavone and theanine.
[0007]
The soybean isoflavone of the present invention refers to a flavonoid compound contained in legume soybean. Specifically, it refers to flavonoid glycosides such as soybean in, genistin, glycine, acetyl soybean in, acetyl genistin, acetyl glycitin, malonyl soybean in, malonyl genistin, malonyl glycitin, and aglycon thereof. These soybean-derived flavonoid glycosides and aglycones can be used alone or in combination of two or more. The soybean isoflavone of the present invention can be obtained from soybean by a usual extraction method. For example, water extraction, hot water extraction, ethanol extraction, and water-containing ethanol extraction. Moreover, what is marketed as an extract can be used as it is. The extract can be widely used regardless of the degree of purification as long as it contains soy isoflavone.
[0008]
The theanine of the present invention refers to L-theanine (L-glutamic acid-γ-monoethylamide). Theanine is a glutamic acid derivative that is abundant in tea leaves, especially gyokuro, and is known as a delicious component of tea. The theanine of the present invention can be obtained by a method in which hot water is extracted from tea leaves such as green tea, oolong tea and black tea and purified by ion exchange chromatography or the like. Alternatively, glutamic acid can be heated under high pressure to produce pyrrolidone carboxylic acid, added with monoethylamine anhydride and heated under high pressure for synthesis. L-theanine is permitted as a food additive, and a commercially available food additive theanine may be used.
[0009]
Royal jelly is secreted into the royal kingdom through its pharyngeal gland and maxillary gland in order to grow queen bees. Raw royal jelly is collected from the royal kingdom and debris removed. The royal jelly of the present invention includes, in addition to the above-mentioned raw royal jelly, a concentrate of raw royal jelly, a dilution obtained by adding lactose, starch, etc. to raw or concentrated royal jelly, an extract extracted from raw or concentrated royal jelly, or a concentrate thereof, and raw or Any of those obtained by deproteinization from concentrated royal jelly or its concentrate can be used. The amount of the royal jelly of the present invention is based on the amount converted to raw royal jelly. For example, 4 g of concentrated royal jelly obtained by removing water from 10 g of raw royal jelly and 1 g of deproteinized royal jelly concentrate obtained by deproteinization of 10 g of raw royal jelly are both as 10 g of raw royal jelly. handle.
[0010]
The weight composition ratio of soy isoflavone, theanine and royal jelly according to the present invention is not particularly limited, but preferably the weight composition ratio is soy isoflavone amount / theanine amount = 0.001-50, and royal jelly is blended Converts royal jelly into raw royal jelly, and the weight composition ratio is soy isoflavone amount / theanine amount = 0.001-50, soy isoflavone amount / royal jelly amount = 0.001-50. More preferably, soy isoflavone amount / theanine amount = 0.005-10, and when blending royal jelly, the royal jelly is converted to raw royal jelly soy isoflavone amount / theanine amount = 0.005-10, soy isoflavone amount / The amount of royal jelly = 0.005-10. Particularly preferably, soy isoflavone amount / theanine amount = 0.01-5, and when blending royal jelly, the royal jelly is converted to raw royal jelly soy isoflavone amount / theanine amount = 0.01-5, soy isoflavone amount / The amount of royal jelly = 0.01-5.
[0011]
The daily intake of soybean isoflavone, theanine and royal jelly according to the present invention is not particularly limited, but soybean isoflavone is 0.1 mg to 10 g daily, theanine is 0.1 mg to 10 g daily, and royal jelly is raw. It is preferable to formulate so that 0.1 mg to 10 g can be ingested per day in terms of royal jelly. More preferably, soybean isoflavones may be formulated so that 1 to 500 mg per day, 1 to 1,000 mg per day for theanine, and 1 to 1,000 mg per day for royal jelly converted to raw royal jelly.
[0012]
The form of the female hormone abnormal disorder improving agent according to the present invention is not particularly limited. For example, tablets, granules, capsules, powders, beverages, gums, chocolates, strawberries, noodles, bread, cakes, biscuits, canned foods, retort foods, livestock meat products, marine products, margarine, butter, mayonnaise, etc. Forms such as pharmaceuticals and foods can be employed. Of these, capsules, tablets, granules, beverages and the like are preferable.
[0013]
The female hormone abnormal disorder ameliorating agent according to the present invention includes nutrient enhancers such as herbal medicines, vitamins, minerals, and amino acids, lactose, starch, cellulose, maltitol, and dextrins as long as the effects of the invention are not impaired. Forming agents, surfactants such as glycerin fatty acid esters and sucrose fatty acid esters, coating agents such as gelatin, shellac, and zein, fats and oils such as wheat germ oil, rice germ oil, and safflower oil, beeswax, rice bran wax, In addition, waxes such as carnauba wax, sweeteners such as sucrose, glucose, fructose, stevia, saccharin, and sucralose, and acidulants such as citric acid, malic acid, and gluconic acid can be appropriately blended. Herbal medicines include ginseng, ginseng, ginseng, reishi, propolis, agaricus, blueberries, ginkgo biloba, bifidobacteria, etc. It is preferable to use pomegranate, black cohosh, chest tree, Pueraria mirifica, French coastal pine bark extract, and γ-oryzanol, which are effective for premenstrual syndrome. These herbal medicines can be blended according to the usual dosage form such as extracts, juices, concentrates thereof, and herbal dry powders as necessary.
[0014]
【Example】
Next, representative examples will be given to describe the present invention in detail, but the present invention is not limited thereto. The compounding amount shown in the examples indicates wt%.
[0015]
Example 1 Capsule formulation Formulation amount (%)
1. Soy isoflavone 15.0
(Commercially available soybean extract containing 40% soybean isoflavone)
2. Theanine (commercially available food additive L-theanine) 15.0
3. Potato starch 65.0
4). Sucrose fatty acid ester 5.0
(Manufacturing method)
Ingredients 1 to 4 were uniformly mixed and filled into No. 2 hard capsules with a hard capsule filling machine to obtain a capsule according to the present invention having an internal volume of 250 mg.
[0016]
Example 2 Capsule formulation Formulation amount (%)
1. Soy isoflavone 15.0
(Commercially available soybean extract containing 40% soybean isoflavone)
2. Theanine (commercially available food additive L-theanine) 15.0
3. Royal Jelly 10.0
(Using 35g of concentrated royal jelly obtained by freeze-drying 100g of raw royal jelly)
4). Potato starch 55.0
5). Sucrose fatty acid ester 5.0
(Manufacturing method)
Ingredients 1 to 5 were uniformly mixed, and No. 2 hard capsules were filled with a hard capsule filling machine to obtain a capsule according to the present invention having an internal volume of 250 mg.
[0017]
Comparative Example 1 Comparative Example 1 was obtained by replacing soybean isoflavone, theanine and royal jelly with potato starch in Example 2 capsules containing no soy isoflavone, theanine and royal jelly.
[0018]
Comparative Example 2 Capsule not containing theanine and royal jelly In Example 2, a capsule obtained by replacing theanine and royal jelly with potato starch was used as Comparative Example 2.
[0019]
Comparative Example 3 Comparative Example 3 was obtained by replacing soybean isoflavone and royal jelly with potato starch in Example 2 capsules containing no soy isoflavone and royal jelly.
[0020]
Example 3 Tablet formulation Formulation amount (%)
1. Soy isoflavone 20.0
(Commercial soybean extract containing 5% soybean isoflavone)
2. Theanine (commercially available food additive L-theanine) 20.0
3. Royal Jelly 10.0
(Use a prepared royal jelly obtained by adding 65 g of corn starch to 35 g of concentrate obtained by freeze-drying 100 g of raw royal jelly)
4). Lactose 47.0
5). Sucrose fatty acid ester 3.0
(Manufacturing method)
After ingredients 1 to 4 were granulated with a fluid bed granulator, ingredient 5 was added, and a tablet with a weight of 300 mg was obtained with a tableting machine.
[0021]
Example 4 Granule formulation Formulation amount (%)
1. Soy isoflavone 40.0
(Commercial soybean extract containing 30% soybean isoflavone)
2. Theanine (commercially available food additive L-theanine) 5.0
3. Royal Jelly 5.0
(Using 35g of concentrated royal jelly obtained by freeze-drying 100g of raw royal jelly)
4). Cellulose 10.0
5). Dextrin 15.0
6). Lactose 25.0
(Manufacturing method)
After mixing components 1 to 6 uniformly, the mixture was granulated with an extrusion granulator and dried with a shelf dryer at 70 ° C. for 3 hours to obtain granules.
[0022]
Example 5 Beverage formula Blending amount (%)
1. Soy isoflavone 0.05
(Commercial soybean extract containing 80% soybean isoflavone)
2. Theanine (commercially available food additive L-theanine) 0.10
3. Royal Jelly 0.10
(Use 10g of deproteinized royal jelly concentrate obtained by deproteinizing 100g of raw royal jelly and concentrating)
4). Citric acid 1.00
5). Sucrose 10.00 6. Sucrose fatty acid ester 0.50
7). Fragrance 0.20
8). Purified water 88.05
(Manufacturing method)
Ingredients 1-7 are dispersed and dissolved in ingredient 8 and mixed uniformly with a homomixer. It heated to 90 degreeC and filled the glass bottle, and the bottle drink containing 100 ml was obtained.
[0023]
【The invention's effect】
The present invention can provide pharmaceuticals, foods, and the like excellent in female hormone abnormal disorder improving effect. The effects of the present invention will be described below with experimental examples.
[0024]
Experimental example 1
Method: The effect of improving menopause was investigated in 100 women complaining of symptoms of menopause. The women are divided into 5 groups of 20 people, the first group is Comparative Example 1, the second group is Comparative Example 2, the third group is Comparative Example 3, the fourth group is Example 1, the fifth group The capsules of Example 2 were ingested for 2 months so that there were 2 capsules per day, and a questionnaire survey was conducted on each symptom at the start and end of the test. The questionnaire of the menopausal disorder improvement effect test was scored according to the following menopausal disorder questionnaire table, and the total was used as the menopause index, and the climacteric index at the start and end of the study was compared.
[0025]
Symptoms are: (1) the waist and limbs cool down, (2) can't sleep well at night, (3) easy to get angry, often frustrated, (4) heart palpitations, (5) hot face, (6) easy to sweat, (7) numbness of limbs, (8) often depressed, (9) headache, nausea, dizziness, (10) easy to get tired, (11) stiff shoulder For 11 items, back pain and pain in the limbs, the symptoms were scored according to the degree. "None" if there is no symptom, "weak" if there is a symptom awareness but has little effect on daily life, "medium" if the symptom is severe and sometimes unable to be confused, symptom is very severe, daily life In the case of obstructing the menopause, it was set as “strong”, and it was applied to the score of each item listed in the menopause disability questionnaire, and the total was used as the menopause index.
[0026]
[Table 1]

[0027]
Results: In Comparative Example 1, no change was observed in the menopause index. Although the climacteric index at the end of the tests of Comparative Examples 2 and 3 and Example 1 decreased from that at the start of the test, Example 1 was more excellent, and the effect was improved by using soy isoflavone and theanine in combination. It was. In Example 2 in which the royal jelly was blended, the menopause index was further reduced, and the use of soy isoflavone, theanine, and royal jelly further improved the remarkable effect.
[0028]
[Table 2]

[0029]
Experimental example 2
Method: The effect of improving premenstrual syndrome was examined on 100 women who complained of symptoms of premenstrual syndrome. The women are divided into 5 groups of 20 people, the first group is Comparative Example 1, the second group is Comparative Example 2, the third group is Comparative Example 3, the fourth group is Example 1, the fifth group The capsules of Example 2 were ingested for 2 months so that there were 2 capsules per day, and a questionnaire survey was conducted on each symptom at the start and end of the test. According to the evaluation criteria set independently, the symptom was scored as a premenstrual syndrome index (PMS index), and the PMS index at the start and end of the test was compared. The contents of the questionnaire and how to obtain the PMS index are shown below.
[0030]
Symptoms include abdominal pain, abdominal tension, head ache, stiff shoulders, dizziness, increased appetite, diarrhea, constipation, altered food preferences, body swelling, breast aching or tension, acne Easy to do, rough skin, poor makeup, tiredness, sleepiness, increased cages, frustrated, angry, aggressive, lethargic, depressed, bearish, tearful , Unable to concentrate, reduced efficiency, unable to work as usual, healed to be a woman, hesitated menstruation, quarreled with others, withdrawn at home, wanted to be alone, poorer relationship For each item, the degree was graded according to the symptom, 0 if there was no symptom, 1 if there was a symptom awareness but had little effect on daily life, and the pace of work and housework could slow down 2 if you can do it, 2 if your work or housework slows down, 3 if you can't do it, 4 if you have severe illness, no work or housework, 5 if you have more It was. All the symptoms were scored and the total was taken as the PMS index.
[0031]
Results: In Comparative Example 1, no change was observed in the PMS index. Although the PMS index at the end of the test of Comparative Examples 2 and 3 and Example 1 were all decreased from the start of the test, Example 1 was more excellent, and the effect was improved by using soy isoflavone and theanine together. It was. In Example 2 in which the royal jelly was blended, the PMS index was further decreased, and a significant improvement in the effect was observed by using soybean isoflavone, theanine and royal jelly in combination.
[0032]
[Table 3]

[0033]
Examples 3, 4 and 5 were also tested in the same manner as in Experimental Examples 1 and 2, and excellent climacteric disorder improvement and premenstrual syndrome improvement were observed.
[0034]
As mentioned above, it is clear from the results of the menopausal disorder improvement and premenstrual syndrome improvement tests of Examples 1 to 5 and Comparative Examples 1 to 3 that the female hormone abnormal disorder improving agent containing soy isoflavone and theanine has an excellent effect. became. Furthermore, it became clear that it has the further outstanding effect by combining soybean isoflavone, theanine, and royal jelly.

Claims (2)

An agent for improving premenstrual syndrome, comprising soy isoflavone, theanine and royal jelly. The menstruation according to claim 1, wherein the weight composition ratio of the royal jelly converted to soy isoflavone, theanine, and raw royal jelly is soy isoflavone amount / theanine amount = 0.001 to 50, and soy isoflavone amount / royal jelly amount = 0.001 to 50. Agent for improving pre-syndrome.