JP2009013146A - Diabetes treating composition - Google Patents

Diabetes treating composition Download PDF

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JP2009013146A
JP2009013146A JP2007198118A JP2007198118A JP2009013146A JP 2009013146 A JP2009013146 A JP 2009013146A JP 2007198118 A JP2007198118 A JP 2007198118A JP 2007198118 A JP2007198118 A JP 2007198118A JP 2009013146 A JP2009013146 A JP 2009013146A
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diabetes
soybeans
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Takehito Kono
建仁 河乃
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Abstract

<P>PROBLEM TO BE SOLVED: To provide a novel diabetes treating therapeutic agent attaining an excellent diabetes treating effect under a condition without strict dietary restriction. <P>SOLUTION: The diabetes treating composition of the invention is a hair growth substance containing as an effective ingredient at least one member selected from processed half-ripe soybeans, an extract of processed half-ripe soybeans, Polygonum multiflorum, an extract of Polygonum multiflorum, processed Polygonum multiflorum, an extract of processed Polygonum multiflorum, soybeans and an extract of soybeans, and preferably, containing as an effective ingredient processed half-ripe soybeans and/or an extract of processed half-ripe soybeans, and at least one member selected from the group consisting of processed Polygonum multiflorum and an extract of processed Polygonum multiflorum. The processed half-ripe soybeans are obtained by heat-treating soybeans within a range of eliminating the raw taste of the soybeans but not leading to powderization due to overheating of the soybeans, and the processed Polygonum multiflorum is obtained by impregnating raw Polygonum multiflorum with an extract of black soybeans and liquors. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

本発明は、糖尿病に極めて効果的尚且つ安全な糖尿病治療組成物に関する。  The present invention relates to a composition for treating diabetes that is extremely effective and safe for diabetes.

糖尿病は全身にさまざまな障害を起こす恐ろしい病気であり、国内で約740万人の患者がいる推定されている。糖尿病の原因は、加齢のほか、遺伝やストレス、食べすぎ飲みすぎなどがある。糖尿病の治療は食事療法・運動療法・薬物療法という三本柱で構成されている。薬物療法は、経口血糖降下薬を用いる内服療法とインスリンを注射するインスリン療法との二つがある。  Diabetes is a terrible disease that causes various disorders throughout the body, and it is estimated that there are approximately 7.4 million patients in the country. The causes of diabetes include aging, inheritance and stress, and excessive eating and drinking. The treatment of diabetes consists of three pillars: diet, exercise, and pharmacotherapy. There are two types of drug therapy: oral therapy using oral hypoglycemic drugs and insulin therapy in which insulin is injected.

内服療法では、一般的にはナテグリニドとα−グルコシダーゼ阻害剤類の降血糖薬が用いられている。しかしながらこれらの薬は、効き目的には満足できないという弱点が指摘されている一方、ケースにより、発汗、振せん、めまい、および無力を伴う低血糖症状を引起す副作用がある。インスリン注射療法は、いわば、糖尿病治療の最後の手である。残念ながら、このインスリン注射療法は、低血糖、体重増加、インスリン抵抗性、インスリンアレルギー、インスリン浮腫等、いろいろ危険性と副作用が伴っている。臨床では、できる限りこのインスリン療法の使用を避けている。  In internal therapy, nateglinide and α-glucosidase inhibitors such as antihyperglycemic drugs are generally used. However, while these drugs have been pointed out to be unsatisfactory for their purpose, some cases have side effects that cause hypoglycemia with sweating, tremors, dizziness, and helplessness. Insulin injection therapy is the last hand of diabetes treatment. Unfortunately, this insulin injection therapy is associated with various risks and side effects such as hypoglycemia, weight gain, insulin resistance, insulin allergy, and insulin edema. Clinical practice avoids the use of this insulin therapy whenever possible.

このように、糖尿病治療におけるいろんな問題点が存在しているため、現在、新しい作用機序の糖尿病治療薬の開発が求められている。  As described above, since there are various problems in the treatment of diabetes, development of a therapeutic drug for diabetes having a new mechanism of action is currently demanded.

そこで、副作用の少ない天然植物が注目されるようになり、生薬のオウギ、山薬(サンヤク)、天花粉、葛根(カッコン)などの臨床研究は国内外で推進されている。また、本出願の構成物であるツルドクダミの降血糖作用も確認されている。(特表2002−526379号公報、「中薬大辞典」)。ただし、これまでの成果では、天然植物の弱点である効き目が弱いということが解決されていない。  Therefore, natural plants with few side effects have attracted attention, and clinical researches such as herbs such as herbs, mountain medicine (sanyaku), natural pollen, and kakkon are being promoted in Japan and overseas. In addition, the blood glucose lowering effect of Turdukudami, which is a constituent of the present application, has also been confirmed. (Special Table 2002-526379 gazette, "Chokuyaku Dictionary"). However, the achievements so far have not solved the weakness of natural plants.

また、食材からも、大豆の水溶性多糖類(特開2006−52191号公報)、大豆レシチン(特許3545760号公報)、大豆蛋白質(特許3589673号公報)、大豆タンパク質濃縮物(特許3524096号公報)、大豆タンパク質単離物(特許3040477号公報)、大豆粉末からなるタンパク質性担体(特許2927835号公報)などの研究報告が挙げられる。  In addition, soybean water-soluble polysaccharides (Japanese Patent Laid-Open No. 2006-52191), soy lecithin (Japanese Patent No. 3545760), soy protein (Japanese Patent No. 3589673), soy protein concentrate (Japanese Patent No. 3524096) Research reports of soy protein isolate (Japanese Patent No. 3040477), proteinaceous carrier made of soybean powder (Japanese Patent No. 2927835), and the like.

これまでの何れの治療方法においても、食事制限が前提となっている。この厳しい食事制限が臨床で乗り越え難い現実となり、糖尿病治療の壁となる。これについて、臨床医として糖尿病治療の難しさを経験してきた現職日本糖尿病学会理事長の春日雅人教授の言葉を引用されたい。「外来患者さんのうち血糖が良好にコントロールされている率は4割に留まります。いくら新しい治療薬ができても、食欲に負けて食べてしまう人が多いからです。」。(文部科学省特定領域研究ゲノム研究のホームページ(https://www.genome−sci.jp/modules/contents2/rewrite/tc_62.html)により引用、ダウンロード日は2007年6月18日)。このような臨床経験から、緩い食事管理下でも効果の維持できる新規治療薬の重要性が窺える。しかしながら、このような治療薬はまだ発見されていないのが現状である。  In any of the conventional treatment methods, dietary restrictions are a prerequisite. This strict dietary restriction becomes a reality that is difficult to overcome in clinical practice, and becomes a barrier to diabetes treatment. Please cite the words of Professor Masato Kasuga, the incumbent director of the Japanese Diabetes Society, who has experienced difficulties in treating diabetes as a clinician. “The percentage of outpatients with good blood glucose control is only 40%. Because no matter how much new treatments are available, many people lose their appetite and eat.” (Quoted from the Ministry of Education, Culture, Sports, Science and Technology's homepage (https://www.genome-sci.jp/modules/contents2/rewrite/tc_62.html), download date is June 18, 2007). This clinical experience suggests the importance of new therapeutic agents that can maintain their effects even under loose diet control. However, at present, such a therapeutic agent has not yet been discovered.

特表2002−526379号公報JP-T-2002-526379 特開2006−52191号公報JP 2006-52191 A 特許3545760号公報Japanese Patent No. 3545760 特許3589673号公報Japanese Patent No. 3589673 特許3524096号公報Japanese Patent No. 3524096 特許3040477号公報Japanese Patent No. 3040477 特許2927835号公報Japanese Patent No. 2927835 「中薬大辞典」、上海科学技術出版社・小学館編、株式会社小学館発行、平成10年5月1日、初版第三刷、第276頁。“Chokuyaku Dictionary”, edited by Shanghai Science and Technology Publishers, Shogakukan, published by Shogakukan Co., Ltd., May 1, 1998, first edition, third edition, page 276.

本発明の目的は、顕著な効果があり、尚且つ、従来の糖尿病治療剤の欠点を克服した新規糖尿病治療組成物を提供することにある。  An object of the present invention is to provide a novel therapeutic composition for diabetes that has a remarkable effect and overcomes the drawbacks of conventional therapeutic agents for diabetes.

また、本発明は、加工半熟大豆(若しくは大豆)とツルドクダミとの組成物(以下、「組成物」をいう)は、優れた糖尿病治療効果を有することを見出した。  Further, the present invention has found that a composition of processed semi-ripe soybean (or soybean) and tsurudukudami (hereinafter referred to as “composition”) has an excellent therapeutic effect for diabetes.

本発明の糖尿病治療剤は、大豆および/またはその抽出物を有効成分として含む。  The therapeutic agent for diabetes of the present invention contains soybean and / or an extract thereof as an active ingredient.

本発明の糖尿病治療剤は、加工半熟大豆および/またはその抽出物を有効成分として含む。  The therapeutic agent for diabetes of the present invention contains processed semi-ripe soybean and / or an extract thereof as an active ingredient.

本発明の糖尿病治療剤は、ツルドクダミおよび/またはその抽出物を有効成分として含む。  The therapeutic agent for diabetes of the present invention contains tsurudukudami and / or an extract thereof as an active ingredient.

本発明の糖尿病治療剤は、加工ツルドクダミおよび/またはその抽出物を有効成分として含む。  The therapeutic agent for diabetes of the present invention contains processed turks and / or extracts thereof as active ingredients.

本発明の糖尿病治療剤は、組成物および/またはその抽出物を有効成分として含む。  The therapeutic agent for diabetes of the present invention contains a composition and / or an extract thereof as an active ingredient.

本発明の糖尿病治療剤は、マメ科植物および/またはその抽出物を有効成分として含む。  The therapeutic agent for diabetes of the present invention contains legumes and / or extracts thereof as active ingredients.

本発明の糖尿病治療剤は、タデ科植物および/またはその抽出物を有効成分として含む。  The therapeutic agent for diabetes of the present invention contains a teraceae plant and / or an extract thereof as an active ingredient.

本発明の加工半熟大豆の加工方法は、生大豆を原材料とし、熱を加える方法とする。  The method for processing processed half-boiled soybean of the present invention is a method in which raw soybean is used as a raw material and heat is applied.

本発明のツルドクダミは、生ツルドクダミと煮黒大豆溶液と黄酒とを混合し、長時間加熱する方法とする。  The turd kudami of the present invention is a method in which raw turd kudami, boiled black soybean solution and yellow liquor are mixed and heated for a long time.

本発明のツルドクダミは、生ツルドクダミを用いる方法もできる。  The method of using the raw swordfish can also be used for the swordfish of the present invention.

本発明の加工半熟大豆は、生大豆を用いる方法もできる。  The processed half-boiled soybean of the present invention can be processed using raw soybeans.

本発明のツルドクダミは、中国でツルドクダミとして流通されている大根牛皮消を用いることもできる。  As for the turd kudami of the present invention, radish cowhide which is circulated as a turd kudami in China can also be used.

本発明のツルドクダミは、中国でツルドクダミとして流通されている大根牛皮消等の近縁植物を用いることもできる。  For the kudu kudaami of the present invention, related plants such as radish beef skin circulated as tsurukudaami in China can also be used.

本発明の糖尿病治療剤によれば、組成物および/またはこれらの組成物の抽出物を有効成分として含むことにより、優れた糖尿病治療効果を発揮することができる。特に、本発明の糖尿病治療剤は副作用がないうえ、1ないし3ヶ月という短い期間で、血糖(HbA1cの値を基準に)を顕著に下げることができる。このうえ、下げすぎ(低血糖)という副作用が伴わない。特に注目されたい特徴としては、このような効果は厳しい食事制限下ではなく、通常食事注意位のレベルで得られた効果であること。この点は、治療の現場にとって極めて重要なことである。  According to the therapeutic agent for diabetes of the present invention, an excellent therapeutic effect for diabetes can be exhibited by including the composition and / or an extract of these compositions as an active ingredient. In particular, the therapeutic agent for diabetes of the present invention has no side effects and can significantly reduce blood glucose (based on the value of HbA1c) in a short period of 1 to 3 months. In addition, there is no side effect of too low (hypoglycemia). Of particular note is the fact that these effects are not under strict dietary restrictions, but are usually obtained at the level of dietary attention. This point is extremely important for the treatment site.

本発明の糖尿病治療組成物は、優れた糖尿病治療効果を有しているうえ、クッキーやせんべい,おかき,あられ、和菓子、クラッカーなどの美味しい食品製剤の形態にも加工できる。これらの美味しい食べ物を摂り、間食欲を満たしながら、糖尿病を治療できる、という意味合いから、本発明の糖尿病治療組成物は、新しい作用機序を持つ糖尿病治療薬であると考えられ、画期的な糖尿病治療剤として評価に値する。  The composition for treating diabetes according to the present invention has an excellent effect for treating diabetes, and can be processed into a form of delicious food preparations such as cookies, rice crackers, rice crackers, arare, Japanese sweets, and crackers. From the meaning that it is possible to treat diabetes while eating these delicious foods and satisfying snacks, the therapeutic composition for diabetes of the present invention is considered to be a therapeutic drug for diabetes having a new mechanism of action, and is a revolutionary. It is worthy of evaluation as a therapeutic agent for diabetes.

以下、本発明の糖尿病治療剤についで具体的に説明する。  Hereinafter, the therapeutic agent for diabetes of the present invention will be specifically described.

1、本発明の組成物に関連する材料  1. Materials related to the composition of the present invention

1−1、黄大豆
本発明の糖尿病治療剤に原料として使用される黄大豆(学名:Glycine max(L.) Merr.)は,マメ科ダイズ属に属する植物種皮の黄色の種子である。原産地は中国で、弥生中期に我が国に伝来し、鎌倉時代から、広く栽培されるようになった。
1-1, yellow soybean Yellow soybean (scientific name: Glycine max (L.) Merr.) Used as a raw material for the therapeutic agent for diabetes of the present invention is a yellow seed of a plant seed coat belonging to the leguminous soybean genus. The place of origin was China, which came to Japan in the middle part of Yayoi and has been widely cultivated since the Kamakura period.

大豆は、形から、大、中、小、色から、黄色、白色、黒色、緑色などに分類できる。黄色い大豆のことを主に「黄大豆(キダイズ)」又は「大豆」と言う。大粒種は昔から多く栽培し、料理に使われている。中粒種は、豆腐、味噌、醤油などの加工品に、小粒種は、主に納豆に使われている。  Soybeans can be classified into large, medium, small, and color from yellow, white, black, and green. Yellow soybeans are mainly referred to as “yellow soybeans” or “soybeans”. Many large seeds have been cultivated and used for cooking. Medium grain seeds are used for processed products such as tofu, miso and soy sauce, and small grain seeds are mainly used for natto.

我が国における黄大豆の品種は、主に、ツルムスメ、ユウヅル、トヨムスメ、トヨコマチ、カリユタカ、トヨホマレ、ユキホマレ、ミヤギシロメ、タチナガハ、オオツル、オオスズ、ホウエン、オクシロメ、ナカセンナリ、スズカリ、スズコガネ、タンレイ、エンレイ、リュウホウ、ギンレイ、スズユタカ、ニシムスメ、トモユタカ、アキシロメ、タチユタカ、フクユタカ、タマウララ、ムラユタカ、ハタユタカ、サチユタカ、アヤコガネ、キタムスメ、サヤナミ、タママサリ、タマホマレ、スズヒメ、スズマル、ユキシズカ、スズノオト、コスズ、スズコマチ、ナットウコツブ、スズオトメ等があり、いずれの品種も原料として本発明の糖尿病治療組成物に使用できる。  The varieties of yellow soybeans in Japan are mainly Tsurume, Yuutsuru, Toyosumume, Toyokomachi, Kariyutaka, Toyohomare, Yukihomare, Miyagi Shiromome, Tachinagaha, Otsuru, Oosuzu, Houen, Okushirome, Nakasenrei, Suzukari, Suzukogane , Suzuyutaka, Nishimurame, Tomoyutaka, Axiromome, Tachiyutaka, Fukuyutaka, Tamaurara, Murayutaka, Hatataka, Sachiyutaka, Ayakokane, Kitasumume, Sayanami, Tamamasari, Tamahomare, Suzuhime, Suzumaru Any of these varieties can be used as a raw material in the composition for treating diabetes according to the present invention.

大豆の摂取量は、1日76gから100gと厚生労働省から推奨している(厚生省:「21世紀における国民健康づくり運動(健康日本21)」、2000)。本発明での糖尿病治療組成物における大豆の使用量は、一日わずか16グラム以下で顕著な糖尿病治療効果が得られた。  Soybean intake is recommended by the Ministry of Health, Labor and Welfare from 76 to 100 g per day (Ministry of Health, Labor and Welfare: “National Health Promotion Movement in the 21st Century (Healthy Japan 21)”, 2000). The amount of soybean used in the composition for treating diabetes in the present invention was only 16 grams or less per day, and a remarkable effect for treating diabetes was obtained.

そこで、本発明は、半熟加工処理法により作った加工半熟大豆が優れた降血糖作用を有していることを見出した。  Therefore, the present invention has found that processed semi-ripe soybeans produced by the semi-ripe processing method have an excellent blood glucose lowering action.

1−1−1、加工半熟大豆の製法  1-1-1. Process for producing processed half-boiled soybeans

原材料:黄大豆:1キログラムを用いた。黄大豆以外に他の色の豆も使用可能と考えられている。  Raw material: Yellow soybean: 1 kilogram was used. In addition to yellow soybeans, beans of other colors are considered to be usable.

加熱器具:フライパンと家庭用ガスコンロと、その他の攪拌用調理小器具を用いた。その他の加熱用器具も使用可能である。例えば、オープン、電子レンジ、トースターなどの家庭用加熱器具と、ホットプレート、マントルヒーター、電気炉、ラバーヒーター、マキツケ型ヒーター、投げ込み型ヒーター、ラボ用ヒーター、電気コンロなどの実験室用または工場用大型加熱器具が挙げられるが、特に限定するものではない。  Heating equipment: A frying pan, a household gas stove, and other cooking utensils for stirring were used. Other heating appliances can also be used. For example, household heating appliances such as open, microwave oven, toaster, and laboratory or factory for hot plates, mantle heaters, electric furnaces, rubber heaters, firewood heaters, throw-in heaters, laboratory heaters, electric stoves, etc. Although a large-sized heating apparatus is mentioned, it does not specifically limit.

加工半熟大豆の製法:ガスコンロでフライパンを予熱してから、1キログラムの乾燥した黄大豆を入れ、中火で加熱を継続しながら、攪拌し、3分後、火を止め、半熟状態の「加工半熟大豆」を得た。半熟とは、黄大豆の生味を消したが、また十分に熱を通していないことを言う。  Preparation of processed half-boiled soybeans: Preheat the frying pan with a gas stove, add 1 kilogram of dried yellow soybeans, stir while continuing to heat over medium heat, turn off the fire after 3 minutes, A half-boiled soybean was obtained. Semi-mature means that the taste of yellow soybeans has been erased, but not enough heat.

1−2、黒大豆
本発明の糖尿病治療剤に原料として使用される黒大豆(学名:Glycine max(L.) Merr.)は,マメ科ダイズ属に属する植物種皮の黒色の種子である。我が国では、北海道と岡山兵庫県は主産地である。血栓症、高血圧、肝臓病、糖尿病、結石症、関節炎、ダイエット、がん予防に効果があると言われ、黒大豆茶、豆乳絞り、豆菓子、お菓子、おかき、味噌、煮込みなどの形で食される。
1-2, Black soybean Black soybean (scientific name: Glycine max (L.) Merr.) Used as a raw material in the therapeutic agent for diabetes of the present invention is a black seed of a plant seed coat belonging to the leguminous soybean genus. In Japan, Hokkaido and Okayama Hyogo Prefecture are the main production areas. Thrombosis, hypertension, liver disease, diabetes, calculus, arthritis, diet, cancer prevention is said to be effective, in the form of black soybean tea, soy milk squeezed, bean confectionery, sweets, rice cake, miso, stew To be eaten.

1−3、黄酒
本発明の糖尿病治療剤に原料として使用される黄酒(ファンチュウ)は、主にもち米と麦麹を原料として、一定の年数(1年ないし数十年)を熟成させた醸造酒である。色が黄色(茶色か琥珀色)となることから「黄酒」と呼ばれる。長期熟成させることから「老酒(老いたお酒)」とも呼ばれている。江戸時代、中川忠英により我が国に紹介された(中川忠英:「清俗紀聞」、1799年)。紹興酒は、わが国でよく知られている黄酒の一つである。黄酒のアルコール度は、熟成年数により多少の差があるが、大よそ、14〜20%である。黄酒はその原産国中国では、主に調理酒として使用されている。
1-3, yellow wine Yellow wine (fanchu) used as a raw material in the therapeutic agent for diabetes of the present invention is aged for a certain number of years (1 to several decades) mainly using glutinous rice and wheat straw as raw materials. It is a brew. Because the color is yellow (brown or scarlet), it is called “Yellow”. It is also called “old liquor” because it is aged for a long time. Introduced to Japan by Tadahide Nakagawa in the Edo period (Tadahide Nakagawa: “Seijun Kimon”, 1799). Shaoxing is one of the well-known yellow wines in Japan. The alcohol level of yellow liquor is about 14 to 20%, although there are some differences depending on the age of aging. Yellow wine is mainly used as cooking liquor in its country of origin.

1−4、ツルドクダミ(「何首烏」若しくは「カシュウ」ともいう。)
本発明の糖尿病治療剤に原料として使用されるツルドクダミは、タデ科植物ツルドクダミ(Polygonum multiflorum Thunb.、ラテン名 Polygoni Multiflori Radix.)の乾燥したものである。中国の宋の時代の「開宝本草」に収載された。塊茎を乾燥したものは「生何首烏」,加熱処理したものを「熟何首烏」という。
1-4, Tsurudukudami (also referred to as “what necklace” or “kashu”)
As a raw material for the therapeutic agent for diabetes according to the present invention, tsurudokudami is a dried product of the genus Polygonum multiflorum chumb. (Latin name: Polygoni Multifluor Radix.). It was listed in “Kaiho Honso” in the Chinese era. The dried tuber is called “raw rice neck” and the heat-treated one is called “mature rice neck”.

ツルドクダミは、emodin,rhein,aloe−emodin,chrysophanol,physcionなどジアントロン類成分、2,3,5,4−tetrahydroxystilbene−2−O−β−D−glucoside、3−methyl−1,6,8−tri−hydroxyanthraquinone、2,6−dihydroxy−benzoic acid、1,2−propanediol−1−(4−hydroxy−phenyl)、emodin−8−O−β−D−glucoside、8−O−β−D−glucopyranoside、chrysophanol 8−O−β−D−glucopyranoside、torachrysone 8−O−β−D−glucopyranoside、aloe−emodin 8−O−β−D−glucopyranoside、chrysophanol 8−O−β−D−(6’−O−malonyl)glucopyranoside、(+)−lyoniresinol−3α−O−β−D−glucopyranoside、2,3,4’,5−tetrahydroxy−trans−stilbene−2−O−β−D−glucopyranoside、2,3,4’,5−tetrahydroxy−trans−stilbene−2,3−di−O−β−D−glucopyranoside、Meindole−3−(L−α−amino−α−hydroxypropionate)、cireorosein、Me gallate、anthraquinones、sennoside A、sennoside Bなどの成分、さらにカシュウの成分的特長として、植物の平均含有量に対して、高いCa,Fe,Cu,K,Mn,ZnとPを含有している。  Turudukudami is a component of diantrons such as emodin, rhein, aloe-emodin, chrysophanol, physcion, 2,3,5,4-tetrahydrostilbene-2-O-β-D-glucoside, 3-methyl-1,6,8-tri. -Hydroxyanthraquinone, 2,6-dihydroxy-benzoic acid, 1,2-propandiol-1- (4-hydroxy-phenyl), emodin-8-O-β-D-glucoside, 8-O-β-D-glucoside, chrysophanol 8-O-β-D-glucopyranoside, torography 8-O-β-D-glucopyranos ide, aloe-emodin 8-O-β-D-glucopyranoside, chrysophanol 8-O-β-D- (6′-O-malonyl) glucopyranoside, (+)-lyonilesinol-3α-O-β-Dracopy, 2,3,4 ', 5-tetrahydroxy-trans-stilbene-2-O-β-D-glucopyranoside, 2,3,4', 5-tetrahydroxy-trans-stilbene-2,3-di-O-β- D-glucopyranide, Mindole-3- (L-α-amino-α-hydroxypropionate), cireorosein, Megalate, anthracuino It contains Ca, Fe, Cu, K, Mn, Zn and P, which are higher than the average plant content, as components such as nes, sennoside A, and sennoside B, and further as a component feature of cashew.

ツルドクタミは、アントラキノン類物質を有するので、生で摂取した場合、便がゆるくなる、若しくは軽い下痢、若しくは下痢をすることがある。このため、ツルドクダミは、普段、熟ツルドクダミに加工してから用いられている。  Turdockami has anthraquinone substances, so when ingested raw, feces may become loose, or mild diarrhea or diarrhea may occur. For this reason, tsurudukudami is usually used after being processed into mature kudukudami.

熟ツルドクダミは滋養強壮作用がある。耳鳴り、白髪、不眠症、精子発育不良、足腰の衰え、高脂血症、慢性肝炎、神経衰弱などの治療に使用されている。近年、血清コレステロ−ル降下作用を活かし、健康食品としてその摂取が中国並びに欧米で広く普及されている。  Mature tsurudukudami has a nourishing tonic. It is used for the treatment of tinnitus, gray hair, insomnia, poor sperm development, weakness of the legs and legs, hyperlipidemia, chronic hepatitis, and nervous breakdown. In recent years, taking the serum cholesterol lowering action, its intake as a health food has been widely spread in China and Europe and America.

ツルドクグミは、血糖を一度上昇してから降下させる現象が1970年代で既に確認され、その降血糖作用が認められていた(非特許文献1)。ただし、効き目が弱く、臨床では顕著な効果が得られていないため、降血糖剤として用いられていない。  The phenomenon of raising blood sugar once in the 1970s was confirmed in the 1970s, and its blood glucose lowering action was recognized (Non-patent Document 1). However, it is not used as a hypoglycemic agent because its effectiveness is weak and a remarkable effect has not been obtained in clinical practice.

1−4−1、加工ツルドクダミ
本発明では、ツルドクダミの降血糖作用を十分に引き出すためと下痢作用を消すため、黒大豆と黄酒を用い、「加工ツルドクダミ」を製造した。製造方法については、以下に具体的に説明するが、これに限定されるものではない。
1-4-1, Processed Turk Kudami In the present invention, black soybeans and yellow liquor were used to produce “processed tuldok dami” in order to sufficiently bring out the blood glucose lowering action of the tsurukudami and to eliminate the diarrhea action. The manufacturing method will be specifically described below, but is not limited thereto.

1−4−1−1、材料
黒大豆:1キログラム。黄酒:2.5リットル(商品名「福州老酒」、福州造酒厰、中国福州市。その他の酒類、若しくは他のアルコール類やエタノール、その他の溶媒も使用可能)。生ツルドクダミ:10キログラム(中国山東省産、中国平和県県立病院により調達)。
1-4-1-1, Material Black soybean: 1 kilogram. Yellow liquor: 2.5 liters (trade name "Fuzhou Elder Sake", Fuzhou Shuzo, Fuzhou City, China. Other alcoholic beverages, or other alcohols, ethanol and other solvents can also be used). Raw swordfish: 10 kilograms (produced by Shandong Province, China, procured by Heiwa Prefectural Hospital).

1−4−1−2、操作手順:
手順1、黒大豆1キログラムに水5リットルを入れて、弱火で3時間を煮、熱水抽出液1リットルを得た。同様な方法で二回目の抽出を行い、さらに1.5リットルの熱水抽出液を得た。
1-4-1-2, operating procedures:
Procedure 1, 5 liters of water was put into 1 kilogram of black soybeans, and boiled for 3 hours on low heat to obtain 1 liter of hot water extract. A second extraction was performed in the same manner to obtain a 1.5 liter hot water extract.

手順2、得た熱水抽出液2.5リットルと2.5リットルの黄酒を混合し、10キログラムの生ツルドクダミに加え、湯煎法で加熱し、黒大豆の抽出液と黄酒が、全部ツルドクダミに滲みこむまで加熱した。この過程は約10時間が必要である。  Step 2, 2.5 liters of the hot water extract obtained and 2.5 liters of yellow liquor are mixed, added to 10 kilograms of fresh turd kudami, and heated by a hot water method. Heat until soaked. This process takes about 10 hours.

手順3、加熱したツルドクダミを自然乾燥法により乾燥した。  Procedure 3, heated tsurudukudami was dried by a natural drying method.

このように加工を経たツルドクダミは、「加工ツルドクダミ」と呼ぶ。黒大豆の抽出溶液と黄酒とを生ツルドクダミに滲み込ませる目的の達成できるその他の方法も用いることができる。これで挙げた方法に限定するものではない。  Such a crumpled duck is called “processed crumpled duck”. Other methods capable of achieving the purpose of soaking black soybean extract solution and yellow liquor in raw tsurudukudami can also be used. It is not limited to the method mentioned here.

本出願の発明は、加工ツルドクダミと加工半熟黄大豆とを配合することにより、経口摂取で優れた降血糖作用を発現することを見出した。  It has been found that the invention of the present application expresses an excellent antihyperglycemic action by ingestion by blending processed turd kudami and processed semi-yellow soybean.

1−4−2、大根牛皮消
大根牛皮消(学名:Cynanchum bungei Decne.)は、中国山東省を主産地とし、日本での自生は確認されていない。基原の異なる植物Cynanchum auriculatum Royle(Asclepiadaceae)、Asclepias hastata Bunge.Enum.、Cynanchum hastatum Lamarck、Symphyoglossum hastatum(Bunge)Turczaninow、Vincetoxicum hastatum(Bunge)Kuntze.も大根牛皮消としての効果があり、少量ながら薬用植物市場で流通されている。これらの植物並びにこれらの植物の近縁植物、若しくは類似成分を有する植物をもツルドクダミとして用いることができる。
1-4-2, Radish Beef Skin Dishes (Scientific name: Cynanchum bungei Decne.) Is mainly produced in Shandong Province, China, and has not been confirmed to be native in Japan. Plants of different bases such as Cynanchuum auricularum Royle (Asclepiadaceae), Asclepias hasta Bunge. Enum. , Cynanchum hastum Lamarck, Symphyoglossum hastum (Bunge) Turczaninow, Vincetoxicum hastum (Bunge) Kuntze. Is effective as a radish cowhide and is distributed in the medicinal plant market in small quantities. These plants, related plants of these plants, or plants having similar components can also be used as tsurudokudami.

大根牛皮消は、Bungeiside A、Bungeiside B、Bungeiside C、Bungeiside D、Blumenol、(−)Leucanthemitol、 β−Sitosterol glucoside、4−Hydroxyacetophenone、Cynancholなどの成分を含有する。  Radish cowhide contains Bungeide A, Bungeide B, Bungeide C, Bungeide D, Blumenol, (-) Leucanthemil, β-Sitosterol glucoside, 4-Hydroxyacetophenol, C component.

1−5、その他の物質との配合
本発明の実施例に参加した対象者に対し、カロリー管理、甘いものの摂取禁止等の食事制限やライフスタイル改善などを行っていなかった。また、食事や嗜好物などの摂取に対しても制限を加えていなかった。このように、通常条件下で糖尿病治療効果が得られることは、本発明の組成物が、あらゆる食品食材や薬材との更なる配合が可であることを示した。場合により、更なる配合により、糖尿病治療効果を増強することも可能と考えられている。
1-5, Formulation with Other Substances The subjects who participated in the examples of the present invention did not perform dietary restrictions such as calorie management or prohibition of intake of sweets, lifestyle improvement, or the like. In addition, there was no restriction on the intake of food and favorite foods. Thus, the ability to treat diabetes under normal conditions has shown that the composition of the present invention can be further blended with all food ingredients and medicines. In some cases, it is considered possible to enhance the effect of treating diabetes by further blending.

例えば、身体健康状態を改善する食材またはその抽出物、天然薬用物(薬用植物類、若しくは薬用動物類、若しくは薬用鉱物類)またはその抽出物、和漢薬製剤、西洋薬またはその他の化合物などとの配合が挙げられる。特にこれに限定するものではない。  For example, with foodstuffs or extracts thereof that improve physical health, natural medicinal products (medicinal plants, or medicinal animals, or medicinal minerals) or extracts thereof, Japanese and Chinese medicine formulations, western medicine or other compounds Formulation is mentioned. The invention is not particularly limited to this.

天然植物類、若しくは動物類、若しくは鉱物類としては、特にこれらに限定されないが、例えば、以下のものが挙げられる。アイ草、アカザ、アカネ根、赤目柏、アガリクス、阿膠、山東阿膠、ゼラチン、アケビの実、木通子、アケビの蔓性茎、木通、アシタバ、アスナロ葉、甘茶、甘茶づる、アマドコロ、イズイ、亜麻仁、あららぎ、アワビ類の殻、石決明、イカリ草、郁李仁、イズイ、一位、あららぎ、イチヂクの実、イチヂク葉、いちょう、稲苗、威霊仙、岩千舎、岩蕗、茵陳蒿、綿茵陳、淫羊霍、ウイキョウ、宇金(ウコン)、烏頭、烏棗、烏賊骨、烏梅、烏薬、ウツボグサの花穂、夏枯草、兎余糧、裏白樫、ウワウルシ、エイジツ、エゾウコギ、延胡索、延命草、黄耆、オウゴン、尖黄、黄精、黄土、黄柏、桜皮、王不留行、黄連、オオツヅラフジ、防已、オオバコの種子、車前子、オオバコの全草、車前草、弟切草、遠志、カイカ、海金砂、懐牛膝、ゴシツ、牛膝、芥子、海松子、海桐皮、海人草、マクリ、薤白、艾葉、よもぎ、かきどおし、柿の葉、柿のへた、柿の蔕、夏枯草、訶子、何首烏、莪朮、カッコウ、葛根、滑石、カノコソウ、カミツレ、カヤツリ草、カヤの実、ガラナ、訶り勒、訶子、花梨の実、木瓜、楼根、カロコン、カ楼実、カ楼仁、川柳、カワラタケ、寄性竹、カワラヨモギ、茵陳蒿、乾姜、貫衆、貫仲、甘草、東北甘草、西北甘草、カンゾウ、炙甘草、貫仲、款冬花、款冬根、旱蓮草、キキョウ、桔梗、菊花、杭菊花、枳子、枳実、枳殻、きささげ、寄性、寄性竹、北沙参、吉草根、カノコソウ、橘皮、キハダ、黄柏、亀板、ギムネマシルベスタ、胡瓜蔓、羌活、杏仁、玉竹、キラン草、金桜子、金柑、金銀花、銀柴胡、金針菜、金銭草、ンミズヒキ、仙鶴草、グァバの実、蕃果、グァバ葉、枸杞子、くこの実、クコの根皮、地骨皮、枸杞葉、苦参、クズの根、葛根、狗脊、クチナシ、瞿麦、熊笹、熊柳、クルミ、苦棟皮、黒文字、桑茶、桑の葉、桑の実、ケイガイ、荊芥、鶏血藤、桂枝、桂皮、桂通桂皮、広南桂皮、東興桂皮、月桂樹葉、ケツメイシ、毛人参、牽牛子、ケンジツ、拳参、玄参、ゲンノショウコ、膠飴、麦芽糖化飴、紅花、合歓皮、杭菊花、降香、コウシ、香需、紅参、香附子、粳米、厚朴、厚朴実、蒿本、牛黄、五加参、エゾウコギ、牛膝、懐牛膝、川膝、呉茱萸、骨砕補、胡桃肉、五倍子、琥珀、牛蒡子、胡麻、五味子、胡盧巴、柴胡、柴胡木、細辛、ザクロ果皮、石榴果皮、サフラン、鎖陽、山帰来、山査子、山査肉、山慈姑、山梔子、蚕砂、山茱萸、山椒、山豆根、酸棗仁、山扁豆、山薬、三稜、地黄、熟地黄、紫苑、紫花地丁、絲瓜絡、刺五加、エ

Figure 2009013146
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Figure 2009013146
イカズラの花、金銀花、水蛭、すぎな、豆鼓、香鼓、セイソウシ、青黛、青皮、西洋人参、赤芍、石菖根、石松子、石榴果皮、石決明、石膏、石斛、接骨朴、ゼラチン、仙鶴草、全
Figure 2009013146
旋覆花、センブリ、仙茅、川楝子、草果、皀角刺、皀角子、皀莢、猪牙皀莢、桑椹子、桑の実、蒼耳子、蒼朮、古立蒼朮、草荳、桑白皮、桑蛸、桑葉、桑の葉、側柏葉、蘇木、蘇葉、大茴香、大黄、錦紋大黄、大海子、大根草、ダイコンの種子、羅葡子、代赭石、大青葉、大棗、ナツメ、大腹皮、高遠草、沢瀉、沢蘭、ターメリック、郁金、タラ根皮、丹参、淡竹葉、竹葉、タンポポの根、蒲公英根、竹茹、チクジョ、竹節人参、竹葉、知母、茶葉、地楡、丁香、丁字、釣藤鈎、猪苓、陳皮、ツチアケビ、土通草、露草、ツルドクダミの根、何首烏、ツルナ、浜千舎、テイレキシ、天竺黄、天竹黄、天南星、天麻、天木実、天木蔓、天木つる、天門冬、トウガシ、当帰、大和当帰、冬癸子、唐胡麻、灯芯、灯芯草、党参、刀豆、冬虫夏草、唐独活、桃仁、橙皮、当薬、センブリ、土瓜根、土瓜実、独活、唐独活、魚腥草、どくだみ、ジュウヤク、兎糸子、栃の実、杜仲、土通草、土茯苓、山帰来、土別甲、別甲、鳥不止(トリトマラズ)、目木、トンブリ、地膚子、ナズナ、ナタマメ、白刀豆、
Figure 2009013146
肉ジュヨウ、肉豆、錦木、乳香、にわとこ、にわとこ葉、ニンジン、御種人参、生干人参、生晒人参、白参、曲参、忍冬、ネズの実、杜松子、ネズミモチ、女貞子、貝母、川貝母、川貝、麦芽、白芥子、柏子仁、白荳、白鮮皮、白頭翁、白桃花、白刀豆、白南天、南天実、白扁豆、扁豆、麦門冬、開辺麦門冬、巴戟天、破胡紙、はこべ、芭蕉根、はすの実、八角、大茴香、薄荷、ハト麦、炮じハト麦、ハナモツ、ハブ草、炮じハブ茶、浜千舎、浜防風、蕃果、半夏、バンザクロの葉、グアバ葉、半枝連、蕃石榴葉、グアバ葉、胖大海、大海子、板藍根、ヒカイ、彼岸花、彼岸花の根、ヒキオコシ、延命草、ヒゲ人参、菱の実、干葉、
Figure 2009013146
ヒル、水蛭、枇杷葉、檳榔子、覆盆子、茯苓、附子、炮附子、ベッコウ、土別甲、紅ざらさ、扁蓄、防已、茅根、虻虫、防風、蒲黄、撲(ボクソク)、蒲公英根、補骨脂、破胡紙、牡丹皮、牡蠣、瑰花、麻黄、去節麻黄、麻黄根、マクリ、海人草、麻子仁、マタタビの蔓、天木蔓、マタタビの実、天木実、虫瘤、松の実、海松子、松葉、松藤、マツヤニ、松脂、蔓荊子、密蒙花、ミツロウ、さらし蜜蝋、ミロバラン、訶子、無花果、イチヂク実、無花果葉、イチヂク葉、目木、めぐすりの木、綿茵陳、木賊、木通、木通子、木天蓼、マタタビの実の虫瘤、木瓜、木香、桃の葉、門荊、スギナ、射干、益智、益智仁、益母草、夜交藤、矢車実、八ツ目蘭、熊胆、雪の下、ユズリ葉、ユリ根、百合、ヨクイニン、よもぎ、艾葉、雷丸、莱子、羅葡子、羅漢果、羅葡子、李根皮、竜眼肉、劉寄奴、竜骨、硫酸マグネシウム、竜胆、良姜、高良姜、緑豆、霊芝、連翹、連銭草、かきどおし、蓮肉、はすの実、鹿茸、露蜂房、路路通、和羌活、紅花、牛龍黄、鹿茸大補丸、紫雲膏、ウチダの生薬プラスター、ウチダの浴剤、雲南貴精、雲南片玉金、雲南田七、田七人参、霊芝、霊芝エキス、アガリクス加工食品、ウチダの貴珍キトサン、チダの新カイホーイオン化カルシウム、アスリーブ、蜂蜜、ハトムギ、ハトムギ加工食品、プーアル茶、炮じ柿ノ葉、炮じハトムギ、杜仲茶、メグスリノキ茶、などが挙げられる。また、「中薬大辞典」(上海科学技術出版社・小学館編、株式会社小学館発行、平成10年)に掲載されたいずれの中薬をも挙げられる。Although it does not specifically limit as natural plants, animals, or minerals, For example, the following are mentioned. Eye grass, Akaza, Akane Root, Red-eye candy, Agaricus, Aji, Shandong Aji, Gelatin, Akeboshi, Kitsuko, Akebetsu vine stem, Kitsutsu, Ashitaba, Asunaro leaves, Amacha, Amachazu, Amadokoro, Izui , Flaxseed, rough, abalone shell, stone decision, crisp grass, lily grass, lily, Izui, first place, rough, fig fruit, fig leaf, ginkgo, rice seedling, Wei Sensen, Iwasensha, Iwatsuki, Chen Chen蒿, cotton 茵 Chen, lewd sheep 霍, fennel, turmeric, bun, 烏 棗, 烏 bone bone, 烏 ume, glaze, weebo, ear of hay, summer hay, surplus, back white cocoon, walrus, age, Ezoukogi , Yonggang, Longevity grass, Jasmine, Ogon, Thorny yellow, Yellow spirit, Ochery, Jasmine, Cherry bark, Wang instinct, Huang Lian, Psyllium rafuji, Prevention, Psyllium seeds, Precursor, Psyllium whole plant, Car front grass, younger brother cut grass, long-distance, Kaika, sea gold sand, bosom knee, go Tsu, beef knee, lion, sea matsuko, sea paulownia, marine grass, macri, cocoon white, cocoon leaf, wormwood, kakidoshi, bamboo leaf, cocoon leaf, cocoon leaf, summer hay, coconut tree, What's 烏, 莪 朮, cuckoo, kudzu, talc, valerian, chamomile, oyster, grass, cypress, guarana, garlic, coconut, quince, kiso, radish, calocon, caladium, karojin, kawayanagi , Kawaratake, bamboo shoot, bamboo wormwood, chen chen, psoriasis, incense, kanchu, licorice, tohoku licorice, northwest licorice, licorice, licorice licorice, kanchu, sect winter flower, sect winter winter root, lotus root, yellow, Kikyo, Chrysanthemum, Chrysanthemum Chrysanthemum, Eggplant, Berries, Rice husk, Kisage, Donation, Bamboo, Bamboo ginseng, Valerian root, Valeriana, Tachibana peel, Yellowfin, Yellow ginger, Turtle board, Gymnema sylvestre, Pepper vine, Gauze, Apricot kernel, Jade bamboo, Kiran grass, Golden cherry, Gold mandarin, Gold and silver flowers, Silver shihu, Golden needles, Golden grass, Nikuhizuki, Senzaku grass, Guava Fruit, berry, guava leaf, coconut, arachnid, wolfberry root bark, ground bone bark, persimmon leaf, bitterness, kudzu root, kudzu root, spinal cord, gardenia, buckwheat, kumaragi, kumayanagi, walnut, Black-bellied skin, black letters, mulberry tea, mulberry leaves, mulberry, keigui, persimmon, chicken blood, katsura, cinnamon, katsura cinnamon, guangnan cinnamon, dongxing cinnamon, laurel leaves, katsumeishi, hair carrot, checkered cattle Child, Kenjitsu, Ginseng, Ginseng, Gennoshoko, Ginger, Maltose, Safflower, Pleasant skin, Hang chrysanthemum, Fallen incense, Koushi, Incense demand, Red ginseng, Kasuke, Rice, Kobok Enomoto, Beef Yellow, Gokasan, Ezokogi, Beef Knee, Beef Knee, River Knee, Kure Kaki, Bone Fracture, Pepper Meat, Pyramid, Mushroom, Beef Yuzu, Sesame, Gomiko, Pepper, Saiko, Shiba Walnut, spicy, pomegranate peel, stone persimmon peel, saffron, chain yang, mountain return, yamakoko, yakiniku, yamachigo, yamiko, cinnabar, yam, yam, yam root, soy sauce, yam bean, Sanyaku, Sanryu, Ji-Huang, Jukuji-Yo, Shion, Shikachiji-cho, Sword, Sashigoka, D
Figure 2009013146
Rishi, persimmon, persimmon, persimmon, persimmon licorice, akaishi fat, glaze, Yamato glaze, Ogata glaze, red persimmon, serpentine, sasan, north sasan, car forer, car forerunner, sha Insects, comforters, Shujitsuko, mokuchi yellow, shredded sand, ginger, ginger, ginger, pine oil, wheat, rice bran, sone, hemp, moth, Korenen, younger brother cut grass,
Figure 2009013146
Squid flower, gold and silver flower, water syrup, Sudoku, bean drum, incense drum, bullshit, green vine, blue ginseng, red ginseng, stone root, stone matsuko, stone pericarp, stone decision, gypsum, sarcophagus, bone bone, Gelatin, Senzaku grass, all
Figure 2009013146
Whirling flower, assembly, senbei, river lion, grass, horned sashimi, horned horned cocoon, cocoon, tusks cocoon, mulberry cocoon, mulberry seed, cocoon ear, cocoon, old cocoon, grass moth, mulberry white Skin, mulberry leaves, mulberry leaves, mulberry leaves, lateral cocoon leaves, sugi, soba, daikon incense, dai yellow, nishikimon dai yellow, daiko, radish grass, radish seeds, arabiko, daiseki stone, large green leaves, Daegu, jujube, large belly skin, Kotobuki, Sawaran, Sawaran, turmeric, brackish gold, cod root bark, dansang, light bamboo leaves, bamboo leaves, dandelion roots, 蒲 英 英 根, bamboo basket, chikujo, bamboo ginseng, bamboo Leaves, mom, tea leaves, earthenware, scented incense, chopsticks, Tsutomu Satoshi, persimmon, crust, tsuchiakebi, dotsutsukusa, turf, tsurudukudami root, what neck moth, tsuruna, hamasensha, teilexi, heavenly yellow, heavenly bamboo yellow, Tennansei, Tenma, Tenjinmi, Tenjintsuru, Tenkitsuru, Tenmon Fuyu, Togashi, Tokachi, Yamato Toki, Fuyu Toshi, Kara Sesame, Lantern, Lantern Grass, Ginseng, Sword Bean, Cordyceps, Tang Active, peach seed, orange peel, medicinal product, assembly, dope root, dodge fruit, solitary life, tang dokki, fish carp grass, dodomi, juyaku, cocoon paste, tochino fruit, Tochu, dotsutsukusa, doboshi, mountain return, Dobetsu, Bekko, Bird-stopping (Tritomaraz), Megi, Tonburi, Gyoko, Nazuna, Natsume, White sword beans,
Figure 2009013146
Meat Juyo, Meat Beans, Nishiki, Nukako, Niwakoko, Nikotoko, Carrot, Ginseng, Raw Ginseng, Raw Blind Ginseng, White Ginseng, Ginseng, Ninfu, Natsunomu, Miomatsuko, Ratty Mochi, Sadako, Shellfish Mother, river shell mother, river shell, malt, white lion, coconut, white birch, white skin, bald eagle, white peach blossom, white sword bean, white south heaven, south heavenly fruit, white white beans, white beans, barley winter, open side Mumon winter, 巴戟 天, ruptured paper, ladle, radish, lotus seeds, octagon, oak incense, light load, pigeons, cocoon pigeons, hanamotsu, hub grass, konji hub tea, Hamasensha , Beach windbreak, persimmon, semi-summer, banzakuro leaves, guava leaves, half-branches, meteorite foliage, guava leaves, coral sea, great sea lion, plate indigo root, hikai, cluster amaryllis, cluster amaryllis roots, toads, longevity grass, mustache carrot , Rhinoceros, dried leaves,
Figure 2009013146
Hill, Minamata, Yuzuha, Yuzu, Udon Bonsai, Kashiwa, Tsuji, Tsujitsuko, Becko, Dobetsu, Crimson, Scarlet, Prevention, Sone, Helminth, Windproof, Scarlet Yellow, Sumo (Box) , 蒲 英 英 根, complement bone oil, ruptured paper, peony skin, oysters, camellia, hemp, mashed yellow, mackerel, macri, seaweed, asakojin, matababi vine, heavenly tree vine, matatabi fruit, Heavenly tree seeds, wormwood, pine nuts, sea matsuko, pine needles, matsufuji, matsuyani, pine oil, vinegar, mitsuen flower, beeswax, bleached beeswax, milobaran, eggplant, no flower fruit, fig fruit, no flower fruit leaves, fig leaf , Eyes tree, tour tree, cotton candy Chen, bandit, tree street, tree tsuko, wood tempura, matabite berry mass, wood cocoon, wood incense, peach leaf, gate moth, horsetail, sprayed, profit Satoshi, Masutomo Jin, Masu Mother Grass, Yakko, Yagami Ran, Yatsume Ran, Bear Gall, Under the Snow, Lily Leaf, Lily Root, Lily, Yokuinin, Sagebrush, Nagiha, Raimaru, Rinko, Raku , Luo Han Fruit, Luo Zhuang, Lee Neskin, Longan, Ms. Liu Yong, Keel, Magnesium Sulfate, Dragon Gall, Liang, Kora, Mung Bean, Ganoderma, Ream, Rengen Grass, Kakidoshi, Lotus Japanese cypress, deer crab, dew beehive, alleyway, samurai activity, safflower, beef dragon yellow, deer gauze maru, shiongo, uchida herbal medicine plaster, uchida bath agent, yunnan kisei, yunnan katamakin, yunnan Tanachi, Ginseng, Reishi, Ganoderma extract, Agaricus processed food, Uchida's precious chitosan, Chida's new kaiho ionized calcium, Sleeveless, Honey, pearl barley, pearl barley processed food, Pu'er tea, konji potato leaves, For example, candy pearl barley, tochu tea, and megsurinoki tea. In addition, any of the Chinese medicines listed in the “Chūshoku University Dictionary” (Shanghai Science and Technology Publishers, Shogakukan, published by Shogakukan Co., Ltd., 1998) can be mentioned.

天然植物、若しくは動物類、若しくは鉱物類から製造した漢方製剤やエキス、又は顆粒剤としては、特にこれらに限定されないが、例えば、以下の種類が挙げられる。ツムラ湯、ツムラ湯加川辛夷、乙字湯、安中散、十味敗毒湯、八味地黄丸、大柴胡湯、小柴胡湯、柴胡桂枝湯、柴胡桂枝乾姜湯、柴胡加竜骨牡蛎湯、半夏瀉心湯、黄連解毒湯、半夏厚朴湯、五苓散、桂枝加朮附湯、小青竜湯、防已黄耆湯、小半夏加茯苓湯、消風散、当帰芍薬散、加味逍遙散、桂枝茯苓丸、桂枝加竜骨牡蛎湯、麻黄湯、越婢加朮湯、麦門冬湯、真武湯、呉茱萸湯、人参湯、大黄牡丹皮湯、白虎加人参湯、四逆散、木防已湯、半夏白朮天麻湯、当帰四逆加呉茱萸生姜湯、苓桂朮甘湯、猪苓湯、補中益気湯、六君子湯、桂枝湯、七物降下湯、釣藤散、十全大補湯、荊芥連翹湯、潤腸湯、ヨクイニン湯、疎経活血湯、抑肝散、麻杏甘石湯、五淋散、温清飲、清上防風湯、治頭瘡一方、桂枝加芍薬湯、桃核承気湯、防風通聖散、五積散、炙甘草湯、帰脾湯、参蘇飲、女神散、芍薬甘草湯、茯苓飲、香蘇散、四物湯、甘麦大棗湯、柴陥湯、調胃承気湯、四君子湯、竜胆瀉肝湯、当帰キョウ艾湯、麻杏甘湯、平胃散、柴胡清肝湯、二陳湯、桂枝人参湯、抑肝散加陳皮半夏、大黄甘草湯、神秘湯、当帰飲子、六味丸、二朮湯、治打撲一方、清肺湯、温胆湯、滋陰至宝湯、滋陰降火湯、五虎湯、柴朴湯、大防風湯、黄耆建中湯、小建中湯、大建中湯、升麻湯、当帰湯、酸棗仁湯、辛夷清肺湯、通導散、温経湯、牛車腎気丸、人参養栄湯、小柴胡湯加桔梗石膏、立効散、清心蓮子飲、猪苓湯合四物湯、三黄瀉心湯、柴苓湯、胃苓湯、茯苓飲合半夏厚朴湯、五苓散、苓姜朮甘湯、苓甘姜味辛夏仁湯、黄連湯、三物黄芥湯、排膿散及湯、当帰建中湯、川茶調散、桂枝茯苓丸加、麻子仁丸、麻黄附子細辛湯、啓脾湯、大承気湯、桂枝加大黄湯、インチンコウ湯、清暑益気湯、加味帰脾湯、桔梗湯、紫雲膏、生薬コウジン、生薬修治ブシ、および、メタライト、アスタットクリーム、アスタット液、アスタット軟膏、シンフェーズ、トコンシロップ、平胃散料、温清飲、五苓散料、辛夷清肺湯、防已黄耆湯、柴胡加竜骨牡蛎湯、神秘湯、防風通聖散料、黄連湯、柴胡桂枝乾姜湯、疎経活血湯、柴胡桂枝湯、大柴胡湯、麻杏甘石湯、葛根湯、柴胡清肝湯、釣藤散料、麻杏甘湯、葛根湯加川辛夷、三黄瀉心湯、猪苓湯、木防已湯、当帰四逆加呉茱萸生姜湯、抑肝散加陳皮半夏、当帰芍薬散料、六君子湯、桂枝加竜骨牡蛎湯、十味敗毒湯、半夏厚朴湯、竜胆瀉肝湯、温中止痛湯、温清飲、黄連湯、疎風定痛湯、抑肝散加陳皮半夏湯、順血温補湯、竜胆瀉肝湯、太陽爽鼻湯、四薬温血湯、解筋止痛湯、温中止痛錠、桂枝湯、小少陽錠、表湿清澄錠、温清飲、恵麗安順錠、小青竜湯、攻肥聖健錠、黄連湯、五味利水錠、保中回帰錠、清熱瀉火錠、黄連解毒湯、竜化順清錠、双鈎順気錠、降逆水気錠、天地通暢錠、半裏回陽錠、下焦通水錠、解表舒筋錠、酸棗仁湯、婦徳安潤錠、太陽爽鼻湯、葛根湯加川辛夷、四薬温血湯、四物湯、麦門冬湯、明華順心錠、芍薬甘草湯、理気利心錠、半夏厚朴湯、荊芥連翹湯、表解麗容錠、中焦健和錠、半夏瀉心湯、黄解丸加大黄、黄連解毒丸、乾姜人参半夏丸、駆血丸、桂枝茯苓丸、桂苓加大黄丸、三黄丸、大甘丸、桃核承気丸、麻子仁丸、理中丸、六味丸、八味丸、安中散、加味逍遙散、消風散、通導散、当帰芍薬散、排膿散、平胃散、人参養栄湯、大黄甘草湯、加味帰脾湯、当帰芍薬散、補中益気湯、八味地黄丸、小柴胡湯、十全大補湯、柴苓湯、柴胡桂枝湯、五苓散、桂枝茯苓丸、桂枝加朮附湯、加味逍遙散、葛根湯、黄連解毒湯などが挙げられる。  The Kampo preparations and extracts or granules produced from natural plants, animals, or minerals are not particularly limited, and examples thereof include the following types. Tsumura hot water, Tsumura hot water Kagawa hot pepper, Otsuji hot spring, Anchu-san, Jumi-detoxicated hot water, Hachimi-jio-maru, Dai-saiko-yu, Sho-saiko-yu, Saiko-Kei-do, Saiko-Kei-do Karui-yu, Saiko-ka-ryo-ryo oyster hot water , Semi-Summer Hot Spring, Huangren Detox, Semi-Summer Hot Spring, Gojosan, Katsueka Hot Spring, Shosei Ryuyu, Hakuho Hakuyu, Shohanka Kayu, Shofusan, Toki San, kamisansan, katsushikamaru, katsushika dragon bone oyster bath, maoyu, oshitsuka kanyu, barontoyu, shinbuyu, kureyu, ginseng, daikon peony, and white tiger carrot Hot springs, Shigyakusan, Kibo already hot springs, Hansaku Shirakaba Tenma hot springs, Toki four hot springs Kuga ginger hot springs, 苓 Katsura hot springs, Sachu hot springs, Hochuekki hot springs, Rikkunshi hot springs, Katsue hot springs, Shichimono Shimo-yu, Choto-san, Juzen-taiho-yu, Tsuren-en-yu, Jun-in-to, Yokuinin-to, Ryokyoku-san, Yokukan-san, Myokan-kanshi-to, Gojo-san, Gosei-san, Kiyokami Fufu-to, Jiju-wan, Katsueka Kayaku-yu, Momonuclear Kiyu, Fufutsu Seiki, Gokansan炙 Amakusa-yu, Kikisu-yu, Sanso-drink, Megami-san, Shakuyaku-kanzo-yu, Akane-drink, Koso-san, Yotsumono-yu, Ganmu-Otsuchi-yu, Shibaku-to-yu, Jijo-jiki-yu, Syoji-ko-yu, Ryobi Chokoku-to, Toki Kyo-en-yu, Aso-kanto, Heigasaku-san, Saiko-sei-Kyoto-yu, Nichien-yu, Keieda-jinjin-yu, Yokukan-san-ka-sen-summer, Daio-kanzo-to, Mystic-yu, Toki-drink , Rokumi-maru, Futaba-yu, Jitsu-zukuri, Seiryo-yu, Hot-boiled hot-spring, Shiyin-jibyo-yu, Shiyin-hoten-yu, Gotora-yu, Saiboku-yu, Daifufu-yu, Hakuen-kenchu-yu, Koken Nakayu, Daikenchuyu, Sasa-yu, Toki-yu, soju-jin-yu, kaisen-sei-lung-yu, tsuden-san, yunkei-yu, ox-sha-jinki-maru, ginseng-yoei-yu, kosa-saiyu Efficacy, Seishin Renko Drinking, Sakai-yu Gomono Hot Spring, San-Hou Sakai-yu, Saiba-yu, Gaspo-yu, Sakai-drinking Semi-Summer Hot Spring, Gojo-san, Sakai Amyu , Houren-yu, Sanmono-koyu-yu, Dyu-san-yu-yu, Tokiken-chu-yu, Kawacha-san-san, Katsushika-maruka, Asako-jinmaru, hemp Tsukushi Hot Spring, Keishi-yu, Daisho-ki-yu, Keieda-ka-Da-yu, Inchinkou-yu, Seikatsu-Kai-to, Kamiki-Spa-yu, Kikyo-to, Shiunko, Herbal Koujin, Herbal Medicine Shuji Bushi, and Metalite , Astat cream, Astat solution, Astat ointment, Shin phase, Tokon syrup, flat stomach powder, hot and cold drinks, gorei powder, sardine sung lung hot water, anti-alcoholic hot springs, saiko kuryu oyster hot water, mystic hot water, Hofutsu Seiki-san, Huangren-yu, Saiko-Kei-Dai-yu, Ryokyo-Kai-yu, Saiko-Kei-do, Dai-saiko-to, Ma-Akan-Ashiishi-yu, Kakkon-Yu, Saiko-Kei-Kyo-to, Cho-to-san, Mao-Ama Hot water, Kakkon Yukagawa hot spring, Sankoenshin-yu, Tsukuyu, Kibo already hot water, Toki four reversal Kure ginger hot spring, Yokukan Sanka Chen-skin summer, Toki medicinal powder, Rikkunshi hot water, Katsura Edaka Ryubon Oyster Hot Spring, Jumi-Kotobuchi Hot Spring, Semi-Summer Koboku Hot Spring, Ryu Gyotsu Liver Hot Spring, Hot Discontinuation Hot Spring, Hot Wash Drinking, Hou Ren Hot Spring, Loosening Constant Pain Hot Spring, Yokukan Sanka Chen Skin Hot Summer Hot Spring, in order Blood temperature hot water , Ryu-Gonjyo-to, Taiyo-San-no-yu, Yokkayaku-to, Unmusume-ta-to, Hot-discontinued-pain-tablet, Keieda-yu, Xiaoyang-table, Moisture clarified tablet, Warm refresher, Yeangshun tablet, Kosei Ryuyu, Seisei St. Ken Tablets, Huang Renyu, Gomi Risui Tablets, Hochu Reversion Tablets, Seong Heng Hot Lock, Huang Ren Detoyu, Ryujin Jun Seiki Tablets, Shuang San Seok Tablets, Feng Shui Water Tablets , Tianchi Tsutsugi Lock, Semi-backed Yoyo Tablets, Shiso Jiayu Tablets, Unlocked Samurai Tablets, Sotsujinto, Nintoku Anjun Tablets, Taiyosou Ryoyu, Kakkonyu Kagawa Hotan, Four Medicines , Mumon Fuyuto, Minghua Junshin Tablets, Shakuyakukanzoto, Rikirishinko Tablets, Semi-Summer Koboku-yu, Chorento-yu, Omo-ryo Yeo-ju, Nakashou Ken-wa Tablets, Hanatsuo Shinshin-to, Huang-maru , Huangren detoxification circle, ginseng ginseng semi-summer circle, blood-breathing round, Katsushida Karasuma, Katsura Kaka Daihokumaru, Sanoh Maru, Daikanmaru, Momokashikimaru, Asako Jinmaru, Rinaka Maru, Rokumi Maru, Hachimaru, Annaka-san, Kamisan-san, Shofu-san, Tsutsu-san, Tokiyaku-san, Dyu-san, Hirakusan-san, Ninjin-yoei-to, Dai Licorice, Kami Kisyu, Toki Yakusan, Hochuekki-to, Hachimi-jio-maru, Sho-saiko-yu, Juzen-dai-so-yu, Saiko-yu, Saiko-Kei-eda, Gojo-san, Kei-sha-Kan-maru , Katsueka Kasetsuyu, Kamisansan, Kakkonto, and Houren Detox.

そのた、食物や食材などの配合をも挙げられる。  In addition, it can be formulated with food and ingredients.

西洋薬としては、わが国の厚生省において使用認可されているすべての薬が挙げられる。  Western medicine includes all medicines approved for use by the Ministry of Health and Welfare in Japan.

1−6、組成物の抽出物を用いる場合  1-6, when using an extract of the composition

また、本発明の糖尿病治療剤の組成物の有効成分として、組成物から溶媒により抽出された抽出物、あるいはこの抽出物を乾燥させて得られる乾燥物を用いてもよい。  Further, as an active ingredient of the composition for treating diabetes according to the present invention, an extract extracted from the composition with a solvent, or a dried product obtained by drying the extract may be used.

また、組成物および/またはその抽出物を濃縮、乾固した物を水や極性溶媒に再度溶解したり、あるいはこれらの生理作用を損なわない範囲で脱色、脱臭、脱塩等の精製処理を行ったり、カラムクロマトグラフイー等による分画処理を行なった後に本発明の糖尿病治療剤に用いてもよい。組成物および/またはその抽出物ならびにその処理物(または分画物)は、各処理(または分画)後に凍結乾燥し、使用時に溶媒に溶解して用いてもよいし、あるいはリポソーム等のベシクルやマイクロカプセル等に内包させて用いてもよい。  In addition, the composition and / or the extract thereof concentrated and dried can be dissolved again in water or a polar solvent, or purification treatment such as decolorization, deodorization, and desalting can be performed without impairing these physiological functions. Alternatively, it may be used in the therapeutic agent for diabetes of the present invention after fractionation by column chromatography or the like. The composition and / or the extract thereof and the processed product (or fraction) thereof may be lyophilized after each treatment (or fraction) and dissolved in a solvent at the time of use, or a vesicle such as a liposome. Or may be encapsulated in a microcapsule or the like.

次に、組成物の抽出物の調製方法について以下に説明する。  Next, the preparation method of the extract of a composition is demonstrated below.

組成物の抽出物を調製する際、生の組成物を用いてもよいが、抽出効率を考慮すれば、細切、乾燥、粉砕等の処理を行なった後に抽出を行なうことが好ましい。抽出は、抽出溶媒に浸漬するか、あるいは超臨界流体や亜臨界流体を用いて行なうことができる。抽出溶媒を用いる場合、抽出効率を上げるため、抽出溶媒を攪拌したり、あるいは抽出溶媒中でホモジナイズしたりしてもよい。抽出温度は、例えば約5℃から、抽出溶媒の流点+10℃以下の温度までの範囲内にするのが好ましい。抽出時間は、抽出溶媒の種類や抽出温度によっても異なるが、例えば、約1分間〜約14日間とするのか好ましい。  When preparing an extract of the composition, a raw composition may be used. However, in consideration of extraction efficiency, it is preferable to perform extraction after processing such as chopping, drying, and pulverization. The extraction can be performed by immersing in an extraction solvent, or using a supercritical fluid or a subcritical fluid. When an extraction solvent is used, the extraction solvent may be stirred or homogenized in the extraction solvent in order to increase extraction efficiency. The extraction temperature is preferably in the range of, for example, about 5 ° C. to a temperature of the extraction solvent pour point + 10 ° C. or lower. The extraction time varies depending on the type of extraction solvent and the extraction temperature, but is preferably about 1 minute to about 14 days, for example.

抽出溶媒の種類としては、特に限定されないが、例えば、水や有機溶媒が挙げられる。有機溶媒としては、メタノール,エタノ−ル,1−プロパノ−ル,2−プロパノ−ル,n−ブタノール,s−ブタノール,t−ブタノールなどの低級アルコ−ル類、エチレンゲリコール,1,3−ブチレンゲリコール,プロピレンゲリコ−ル,ジプロピレングリコ−ル,グリセリン等の多価アルコール類、ジエチルエーテル,ジプロピルエ−テル等のエ−テル類、酢酸ブチル,酢酸エチル等のエステル類、アセトン,エチルメチルケトン等のケトン類、ギ酸,酢酸などの有機酸類、ジメチルスルホキシド、アセトニトリル、テトラヒドロフラン、ジオキサン、フエノール類、その他の親油性有機溶媒(例えば、クロロホルム、ペンタン、ヘキサン、シクロヘキサン、ベンゼン、トルエン、キシレンならびにナタネ油などの植物油脂)などを用いることができ、これらのうち一種または2種以上を選択して用いることができる。これらのうち、安全性の点で、水またはエタノールが好ましい。また、生理食塩水,リン酸緩衝液,リン酸緩衝生理食塩水等を用いてもよい。さらに、水や二酸化炭素,エチレン,プロビレン,エタノ−ル,メタノ−ル,アンモニアなどの1種または2種以上の超臨界流体や亜臨界流体を用いてもよい。  Although it does not specifically limit as a kind of extraction solvent, For example, water and an organic solvent are mentioned. Examples of the organic solvent include methanol, ethanol, 1-propanol, 2-propanol, n-butanol, s-butanol, t-butanol, and other lower alcohols, ethylene gericol, 1,3- Polyhydric alcohols such as butylene gel, propylene gel, dipropylene glycol and glycerin, ethers such as diethyl ether and dipropyl ether, esters such as butyl acetate and ethyl acetate, acetone and ethyl Ketones such as methyl ketone, organic acids such as formic acid and acetic acid, dimethyl sulfoxide, acetonitrile, tetrahydrofuran, dioxane, phenols, and other lipophilic organic solvents (eg, chloroform, pentane, hexane, cyclohexane, benzene, toluene, xylene and Vegetable oils such as rapeseed oil) Rukoto can, can be selected and used one or at least two of them. Of these, water or ethanol is preferable from the viewpoint of safety. Further, physiological saline, phosphate buffer, phosphate buffered saline, or the like may be used. Furthermore, you may use 1 type, or 2 or more types of supercritical fluids and subcritical fluids, such as water, a carbon dioxide, ethylene, a propylene, ethanol, methanol, ammonia.

2、作用効果  2. Effect

本発明の糖尿病治療剤は、加工半熟大豆と加工ツルドクダミとの組成物、および/またはこれらの組成物の抽出物を有効成分として含むことにより、優れた糖尿病治療効果を有する。特に、本発明の糖尿病治療剤によれば、これらの組成物および/またはその抽出物を有効成分として含むことにより、1〜3ヶ月間で厳格な食事制限を行わずに血糖を正常閾値(HbA1cを指標)に安定させることができる。  The therapeutic agent for diabetes of the present invention has an excellent therapeutic effect for diabetes by containing a composition of processed semi-ripe soybeans and processed turks and / or extracts of these compositions as active ingredients. In particular, according to the antidiabetic agent of the present invention, by containing these compositions and / or extracts thereof as active ingredients, blood sugar is reduced to a normal threshold (HbA1c) without strict dietary restriction within 1 to 3 months. Can be stabilized as an index).

これに対して、従来の糖尿病治療剤は、効き目が不十分か効きすぎるか(効きすぎる場合低血糖を引起す)、または、インシュリンのように体重増加、浮腫や心不全をきたす副作用がある。  On the other hand, conventional anti-diabetic agents have side effects that are insufficient or too effective (cause hypoglycemia if they are too effective), or that cause weight gain, edema, and heart failure like insulin.

特に注目されたいのは、従来の糖尿病治療剤がその治療効果を安定させるには、厳格な食事制限が必要とされる。現実では、食欲に負けて食事制限を守りきれず、治療効果を維持できない、とのような治療失敗者が全体患者の約6割を占めた。(現職日本糖尿病学会理事長の春日雅人教授により、前出〔0007〕項)。これに対し、本発明物は、厳格な食事制限を行わないで安定した治療効果を挙げられることは、従来の糖尿病治療剤と本質的な差異であり、革新的な治療薬であると考えられる。  Of particular note, strict dietary restrictions are required for conventional therapeutic agents for diabetes to stabilize their therapeutic effects. In reality, about 60% of all patients were unsuccessful in their treatment, such as being unable to maintain their dietary restrictions because they lost their appetite and could not maintain their therapeutic effects. (Previous paragraph [0007], by Professor Masato Kasuga, the current President of the Japanese Diabetes Society). On the other hand, the present invention is considered to be an innovative therapeutic agent, which is an essential difference from conventional antidiabetic agents and that it can provide a stable therapeutic effect without strict dietary restriction. .

また、〔0005〕と〔0006〕と〔0043〕項の先行研究文献からは、このような効果が、単品で用いても発現し得ない効果であることが判明できた。従って、本発明で発見した厳格な食事制限を行わないで安定した治療効果を得るには、本発明の組成物のような特定の配合が必要となり、前提となる。  In addition, from the previous research documents in [0005], [0006] and [0043], it has been found that such an effect cannot be manifested even when used alone. Therefore, in order to obtain a stable therapeutic effect without performing the strict dietary restriction discovered in the present invention, a specific formulation such as the composition of the present invention is necessary and presupposed.

本発明物は、機能の低下した神経感覚を回復させる効果がある(特許第3830960号「育毛物質」、〔0099〕項)。よって、本発明の組成物は、糖尿病の各合併症、少なくとも神経障害合併症に対し、直接治療できることを示唆した。これに対し、また、従来の糖尿病治療剤は、血糖を下げる効果により間接的に糖尿病合併症の発生を予防するしか機能しない。  The product of the present invention has the effect of recovering the neurosensory with reduced function (Patent No. 3830960 “Hair-growth substance”, item [0099]). Therefore, it was suggested that the composition of the present invention can directly treat each complication of diabetes, at least neurological disorder complication. On the other hand, conventional anti-diabetic agents function only to prevent the occurrence of diabetic complications indirectly due to the effect of lowering blood glucose.

3、組成物の配合量  3. Composition amount

本発明の組成物の組成および配合量は以下のように示すが、これに限定されるものではない。組成物における加工半熟大豆の重量は、全重量に対して1−99重量%であるのが好ましい。組成物におけるツルドクダミの重量は、全重量に対して0.1−99重量%であるのが好ましい。  The composition and blending amount of the composition of the present invention are shown as follows, but are not limited thereto. The weight of the processed half-boiled soybean in the composition is preferably 1 to 99% by weight based on the total weight. It is preferable that the weight of the mulberry beetle in the composition is 0.1 to 99% by weight based on the total weight.

本発明における組成物および/またはその抽出物の配合量は、糖尿病治療剤の形態(例えば、クッキーやパン、煎餅、パウダー、ドリンクなどの飲食品)等によって調整することができるが、糖尿病治療剤の全重量に対して1−100重量%であるのが好ましい。  The blending amount of the composition and / or the extract thereof in the present invention can be adjusted depending on the form of the therapeutic agent for diabetes (for example, foods and beverages such as cookies, bread, rice crackers, powders, and drinks). It is preferable that it is 1-100 weight% with respect to the total weight of.

4、糖尿病治療組成物の態様  4. Aspects of composition for treating diabetes

本発明の組成物は、粉砕した状態で摂取することができる。または、粉砕した状態で甘味料などの添加物を添加してから摂取することもできる。または、クッキー類などの洋菓子類に、煎餅や、羊羹、鯛焼きなどの和菓子類に、または、月餅や餃子などの中華菓子、もしくは中華食材類、または、パン類や麺類、おにぎりなどの日常食品類に加工し、摂取することができる。本発明の実験では、組成物の粉砕物を用いた。  The composition of the present invention can be taken in a pulverized state. Or it can also ingest, after adding additives, such as a sweetener, in the grind | pulverized state. Or, confectionery such as cookies, Japanese confectionery such as rice crackers, sheep crab, baked potatoes, Chinese confectionery such as moon cake and dumplings, or Chinese food ingredients, or daily food such as bread, noodles, rice balls Can be processed and ingested. In the experiment of the present invention, a pulverized product of the composition was used.

または、例えば、錠剤、カプセル剤、散剤、細粒剤、顆粒剤などの形態にしてもよい。また、飴やジュース、液剤、シロップ剤、ドリンク剤も挙げられる。  Or, for example, it may be in the form of tablets, capsules, powders, fine granules, granules and the like. In addition, rice cakes, juices, liquids, syrups and drinks are also included.

有効成分である組成物および/またはその抽出物とともに、結合剤、賦形剤、膨化剤、滑沢剤、甘味剤、香味剤などを用いることができる。ここで、錠剤は、シエラックまたは糖で被覆することもできる。また、カプセル剤は、上記の材料にさらに油脂などの液体担体を含有させることができる。シロップ剤およびドリンク剤には、甘味剤、防腐剤、色素香味剤などを含有させてもよい。  Along with the composition which is an active ingredient and / or an extract thereof, a binder, an excipient, a swelling agent, a lubricant, a sweetener, a flavoring agent and the like can be used. Here, the tablets can also be coated with shellac or sugar. In addition, the capsule may further contain a liquid carrier such as fats and oils in the above material. Syrups and drinks may contain sweeteners, preservatives, pigment flavors and the like.

本発明の糖尿病治療剤は、1日に1回ないし数回を摂取するのが好ましい。本発明の研究においては、1日2回、早朝空腹時の摂取と夜の就寝前の摂取とした。  The therapeutic agent for diabetes of the present invention is preferably taken once to several times a day. In the study of the present invention, it was taken twice a day as an intake in the early morning fasting and intake before going to bed at night.

また、本発明の糖尿病治療剤は、発明の効果を損なわない範囲において、降血糖作用(若しくは効果)を有する他の薬物や化合物や他の植物、またはその植物の抽出物と併用してもよい。  In addition, the therapeutic agent for diabetes of the present invention may be used in combination with another drug or compound having a blood glucose lowering action (or effect), another plant, or an extract of the plant, as long as the effect of the invention is not impaired. .

5、実施例  5. Examples

以下、実施例に基づいて本発明をさらに具体的に説明するが、本発明はこれらの実施例に限定されるものではない。  EXAMPLES Hereinafter, although this invention is demonstrated further more concretely based on an Example, this invention is not limited to these Examples.

5−1、実験参加者
本実験に参加したのは、46歳から67歳までの5名の対象者(男性4名、女性1名)である。参加者全員は脱毛や薄毛の悩みを解決する為に組成物を服用した。組成物の服用について、育毛剤としてのそのメリットとリスクを説明し、承諾を得た。
5-1, Participants in the experiment Participating in this experiment were five subjects (4 men and 1 woman) from 46 to 67 years old. All participants took the composition to solve the problem of hair loss and thinning hair. Regarding the use of the composition, I explained its merit and risk as a hair restorer and got consent.

5−2、実験参加者の糖尿病様態
これらの参加者は、いずれも空腹時の血糖が7.8mmol/L(140mg/dl)以上で(1998年のWHO診断基準値)、尚且つ、こうした高血糖状態が3から10年間が続いていた。この間、一部の実験参加者が病院での降血糖薬治療を受けているが、理想な治療効果が得られないままでいた。各実験参加者の詳細状況は、次の通りである。
5-2, Diabetes mode of experimental participants All of these participants had fasting blood glucose of 7.8 mmol / L (140 mg / dl) or more (1998 WHO diagnostic reference value), and these high The glycemic state lasted for 3 to 10 years. During this time, some experimental participants were receiving antihyperglycemic treatment at the hospital, but the ideal therapeutic effect was not obtained. The detailed situation of each participant is as follows.

実験参加者A:年齢45才、男性、罹患年数3年、服用前の血糖値は9.0mmol/Lであった。実験参加者B:年齢52才、女性、罹患年数3年、服用前の血糖値は10.6mmol/Lであった。実験参加者C:年齢56才、男性、罹患年数5年、服用前の血糖値は16.0mmol/Lであった。実験参加者D:年齢59才、男性、罹患年数10年、服用前の血糖値は13.4mmol/Lであった。実験参加者E:年齢67才、男性、罹患年数10年以上、服用前の血糖値は12.1mmol/Lであった。実験参加者BとEは、降血糖薬(英名:l−phenethyl−biguanid)を服用している。  Experiment participant A: Age 45 years old, male, affected 3 years, blood glucose level before taking was 9.0 mmol / L. Experiment participant B: Age 52 years, female, affected years 3 years, blood glucose level before taking was 10.6 mmol / L. Experiment participant C: Age 56 years old, male, affected years 5 years, blood glucose level before taking was 16.0 mmol / L. Experimental participant D: Age 59 years old, male, affected years 10 years, blood glucose level before taking was 13.4 mmol / L. Experiment participant E: Age 67 years old, male, affected for more than 10 years, blood glucose level before taking was 12.1 mmol / L. Experiment participants B and E are taking antihyperglycemic drugs (English name: l-phenethyl-biguanid).

罹患年数は、血液検査により糖尿病と診断された年数である。  The age of disease is the number of years diagnosed with diabetes by blood test.

5−3、投与量および投与頻度  5-3, Dosage and administration frequency

組成物は、夜間就寝前の1回と早朝食前の1回で、1日合計2回を服用した。8g/回、2回/日、合計16g/日でした。服用期間は3〜4ヶ月間であった。  The composition was taken twice a day, once before going to bed at night and once before early breakfast. It was 8g / time, 2 times / day, 16g / day in total. The dose period was 3-4 months.

実験参加者は、毛髪のトラブルで組成物を服用したので、服用に当たり、糖尿病についてのコメントを一切していなかった。当然ながら、実験参加者に対し、食事制限やカロリー管理などの要求をもしていなかった。また、実験参加者自身も糖尿病の治療という意識を持っていないので、食事のスタイルを変えていなかった。  Participants in the experiment took the composition because of hair problems and did not comment on diabetes at all. Of course, they did not request the participants to dietary restrictions or calorie management. In addition, the experiment participants themselves were not aware of diabetes treatment, so they did not change their eating style.

以下の本発明は、  The following present invention

5−4、糖尿病治療効果への評価
血糖値は食事などの影響による変動するがよくある。そこで、本発明における糖尿病治療効果の評価には、血糖値の他、信頼性の高いHbA1cを用いた。HbA1cは、過去1〜2ヶ月間の血糖値の平均状態を示すデータで、治療効果の評価に広く用いられている。
5-4. Evaluation of diabetes treatment effect Blood glucose levels often fluctuate due to dietary effects. Therefore, in order to evaluate the effect of treating diabetes in the present invention, highly reliable HbA1c was used in addition to the blood glucose level. HbA1c is data indicating an average state of blood glucose levels during the past one to two months, and is widely used for evaluation of therapeutic effects.

得た血糖値データは、Student’s t 検定法を用いて統計検定を行った。検定演算処理はMicrosoft Excel 2003で行った。危険率は5%以下をもって有意とした。  The obtained blood glucose level data was statistically tested using the Student's t test method. The test calculation process was performed by Microsoft Excel 2003. The risk rate was significant at 5% or less.

5−5、評価時点
組成物を服用して3ヶ月を経過したところ(4ヶ月未満)で血糖値並びにHbA1cの測定を行った。(組成物を服用する前、実験参加者は、いずれもHbA1cの検査を行っていなかった。)。
5-5, Evaluation time point When 3 months had elapsed after taking the composition (less than 4 months), blood glucose level and HbA1c were measured. (None of the experimental participants had tested HbA1c before taking the composition.)

5−6、結果
実験参加者A:服用後の血糖値は6.3mmol/L、HbA1cは5.4%であった。
実験参加者B:服用後の血糖値は6.9mmol/L、HbA1cは4.9%であった。
実験参加者C:服用後の血糖値は8.3mmol/L、HbA1cは6.6%であった。
実験参加者D:服用後の血糖値は7.7mmol/L、HbA1cは7.2%であった。
実験参加者E:服用後の血糖値は5.9mmol/L、HbA1cは6.8%であった。
5-6, result Experiment participant A: The blood glucose level after taking was 6.3 mmol / L, and HbA1c was 5.4%.
Experiment participant B: The blood glucose level after taking was 6.9 mmol / L, and HbA1c was 4.9%.
Experiment participant C: The blood glucose level after administration was 8.3 mmol / L, and HbA1c was 6.6%.
Experiment participant D: The blood glucose level after administration was 7.7 mmol / L, and HbA1c was 7.2%.
Experiment participant E: The blood glucose level after administration was 5.9 mmol / L, and HbA1c was 6.8%.

服用後の血糖値は、服用前より統計的に有意に低下し(t=5.8、p<0.005)、組成物は、血糖値を下げる効果があることが判明された。  The blood glucose level after taking was statistically significantly lower than before taking (t = 5.8, p <0.005), and it was found that the composition had an effect of lowering the blood glucose level.

上述血糖値は、いずれも血糖値の基準値範囲(4.4〜6.0mmol/L)以下になっていないことから、組成物は、低血糖を引き起こすことがないことが判明された。  None of the above-mentioned blood glucose levels were below the blood glucose standard value range (4.4 to 6.0 mmol / L), and thus the composition was found not to cause hypoglycemia.

HbA1cについて、服用前に測定しておらず、比較不可能に見えるが、しかしながら、このHbA1cは、過去1〜2ヶ月間(2〜3ヶ月間とする文献も数多くある)の血糖値の平均状態を表す証拠的な指標であり、この指標のみにより糖尿病の治療効果の判定ができる。このような判定方法は、日本の臨床で常識的に使用されている。  About HbA1c, it was not measured before taking and it seemed impossible to compare. However, this HbA1c is the average state of blood glucose level in the past 1 to 2 months (there are many literatures for 2 to 3 months) This is an empirical index indicating that the therapeutic effect of diabetes can be determined only by this index. Such a determination method is commonly used in Japanese clinical practice.

健常者のHbA1cの値は6.5%以下で、望ましい値は4.3〜5.8%である。(HbA1c値を1.67を乗じると、概ねのmmol/Lの血糖値が換算される。)。日本糖尿病協会の判断指針では、糖尿病患者の場合、7.0%以下であれば、過去1〜2ヶ月間血糖値がきれいにコントロールされ、良好な治療効果が得られていると判定する。  The value of HbA1c for healthy individuals is 6.5% or less, and a desirable value is 4.3 to 5.8%. (If the HbA1c value is multiplied by 1.67, the approximate blood glucose level of mmol / L is converted). According to the judgment guidelines of the Japan Diabetes Association, in the case of a diabetic patient, if it is 7.0% or less, it is determined that the blood glucose level has been cleanly controlled for the past 1 to 2 months and a good therapeutic effect is obtained.

HbA1cからは、実験参加者全員が、過去1〜2ヶ月間、即ち組成物を服用してから2から1ヵ月後、血糖値が正常閾値までに回復し、尚且つ安定していたことが判った。実験参加者DのHbA1cは7.2%にあったが、服用前の8%(〔0096〕項の方法により換算)からの変化ということを考慮すると、大きいな治療成果が出ていると解釈される。また、このような効果は降血糖薬を服用していても(実験参加者BとE)得られていない結果でもある。  From HbA1c, it was found that all the participants in the experiment had recovered to the normal threshold and were stable for the past 1 to 2 months, that is, 2 to 1 month after taking the composition. It was. Although HbA1c of experiment participant D was 7.2%, it was interpreted that a large therapeutic result was obtained considering the change from 8% before conversion (converted by the method of [0096]). Is done. Moreover, such an effect is also a result which is not obtained even if taking the blood glucose-lowering drug (experiment participants B and E).

以上の結果から、本発明の組成物は、極めて高い糖尿病治療作用を有していることが立証された。  From the above results, it was proved that the composition of the present invention has a very high therapeutic effect for diabetes.

背景技術でも述べたように、大豆とツルドクダミは糖尿病に対し、治療効果を有していることが発見されていた。この二つの植物の配合により、食事制限やカロリー管理などの要求を行っていなかった(〔0088〕項)条件下で治療効果が得られたことは、本発明のオリジナル性であり、これまでの糖尿病治療薬との根本的な違いでもある。この特徴は、臨床現場でずっと乗り越えられずにいた「厳しい食欲制限」との難点を一定レベルでクリアした。  As described in the background art, it has been discovered that soybeans and tsurudukudami have a therapeutic effect on diabetes. It was the originality of the present invention that the therapeutic effect was obtained under the conditions where dietary restrictions and calorie management were not required ([0088]) by combining these two plants. It is also a fundamental difference from antidiabetic drugs. This feature clears the difficulty of “strict appetite restriction” that has not been overcome in clinical practice at a certain level.

また、本発明の組成物を服用している期間中、副作用が全く観察されなかった。考えてみれば、大豆(黄大豆と黒大豆)は、納豆と豆腐をはじめ、日本の食文化において長い食用歴史があって、その安全性が十分に証明されていた。黄酒も中国では3000年以上、日本では200年以上の飲用歴史があって、適量の飲用は健康によい影響を与えることも随分に証明されていた。ツルドクダミは、中国では「補益薬」(体に優しい強壮薬の和漢薬における専門用語)として、1000年以上の食用歴史があり、副作用は観察されなかった。近年、ツルドクダミの血清コレステロール降下作用が発見され、成人病の治療並びに予防の目的で広く使用されている。日本の厚生省も熟ツルドクダミの薬用価値を認め、「日本薬局方」に「カシュウ」として収録し、日本での使用を許可した。よって、本発明の組成物は安全性であることが判明された。  In addition, no side effects were observed during the period of taking the composition of the present invention. If you think about it, soybeans (yellow soybeans and black soybeans) had a long edible history in Japanese food culture, including natto and tofu, and their safety was well proven. Yellow liquor also has a history of drinking in China for over 3000 years and in Japan for over 200 years, and it has been well proven that a proper amount of drinking has a positive effect on health. Tsurudokudami has a history of over 1000 years as a “beneficial agent” (a technical term for a tonic medicine that is gentle on the body) in China, and no side effects were observed. In recent years, the serum cholesterol lowering effect of tsurudukudami was discovered and widely used for the treatment and prevention of adult diseases. The Japanese Ministry of Health and Welfare also recognized the medicinal value of mature tsurukudami and recorded it as “Kashuu” in the “Japanese Pharmacopoeia”, allowing it to be used in Japan. Thus, the composition of the present invention was found to be safe.

以上の結果により、組成物は、厳格な食事制限を行わない条件下で顕著かつ安定な降血糖作用を得られることが明らかとなった。また、該当組成物は、安全であることも判明された。  From the above results, it has been clarified that the composition can obtain a remarkable and stable blood glucose lowering effect under conditions where strict dietary restriction is not performed. The composition has also been found to be safe.

また、顕著な降血糖作用を有しながら、おいしい食品の形にも加工することが出来る。また、この食品形の糖尿病治療薬を以て患者の間食欲を満たしながら治療を行うことができると、本発明の組成物が、これまでにない新奇さを備えている。よって、本発明の組成物は、従来の糖尿病治療剤にない価値を有していることが判明された。  Moreover, it can be processed into a delicious food form while having a remarkable blood glucose lowering effect. In addition, the composition of the present invention has a novelty that has never been achieved when it can be treated while satisfying the appetite of patients with this food-type anti-diabetic agent. Therefore, it was proved that the composition of the present invention has a value not found in conventional therapeutic agents for diabetes.

本発明における組成物は、飲食品の形態に加工することができる。また、室温下で中長期(1年乃至2年)保存することも出来る。その原材料も流通市場から調達できる。よって、産業上の利用が可能である。  The composition in this invention can be processed into the form of food-drinks. It can also be stored at room temperature for medium to long term (1 to 2 years). The raw materials can also be procured from the secondary market. Therefore, industrial use is possible.

Claims (6)

大豆および/または大豆抽出物と、
ツルドクダミ、ツルドクダミ抽出物、加工ツルドクダミ、加工ツルドクダミ抽出物からなる群より選ばれる少なくとも1種とを有効成分として含有することを特徴とする糖尿病治療剤。
Soy and / or soy extract;
A therapeutic agent for diabetes, comprising as an active ingredient at least one selected from the group consisting of tsurudukudami, tsurudukudami extract, processed tsudukudami and processed tsudukudami extract.
加工半熟大豆および/または加工半熟大豆抽出物と、
ツルドクダミ、ツルドクダミ抽出物、加工ツルドクダミ、加工ツルドクタミ抽出物からなる群より選ばれる少なくとも1種とを有効成分として含有することを特徴とする糖尿病治療剤。
Processed soft-boiled soybean and / or processed soft-boiled soybean extract;
A therapeutic agent for diabetes, comprising as an active ingredient at least one selected from the group consisting of tsurudukudami, tsurudukudami extract, processed tsudukudami and processed tsurudukutami extract.
大豆a重量部および大豆b重量部の抽出物(ここで、aおよびbはa+b=100の関係を満たす0以上の数)に対して、
ツルドクダミc重量部、ツルドクダミ抽出物d重量部、加工ツルドクダミe重量部、加工ツルドクダミ抽出物f重量部(ここで、c、d、eおよびfは、3≦c+d+e+f≦100の関係を満たす0以上の数)の割合で配合されていることを特徴とする請求項1に記載の糖尿病治療剤。
For the extract of soybean a part by weight and soybean b part by weight (where a and b are 0 or more satisfying the relationship of a + b = 100),
C. Durcum c, p. D., C. D. E., C. D. E. And f. C. D, e and f are 0 or more satisfying the relationship of 3.ltoreq.c + d + e + f.ltoreq.100. The diabetes therapeutic agent according to claim 1, which is formulated at a ratio of (number).
加工半熟大豆g重量部および加工半熟大豆h重量部の抽出物(ここで、gおよびhはg+h=100の関係を満たす0以上の数)に対して、
ツルドクダミc重量部、ツルドクダミ抽出物d重量部、加工ツルドクダミe重量部、加工ツルドクダミ抽出物f重量部(ここで、c、d、eおよびfは、3≦c+d+e+f≦100の関係を満たす0以上の数)の割合で配合されていることを特徴とする請求項2に記載の糖尿病治療剤。
For an extract of g parts by weight of processed half-ripe soybeans and h parts by weight of processed half-ripe soybeans (where g and h are 0 or more satisfying the relationship g + h = 100),
C. Durcum c, p. D., C. D. E., C. D. E. And f. C. D, e and f are 0 or more satisfying the relationship of 3.ltoreq.c + d + e + f.ltoreq.100. The therapeutic agent for diabetes according to claim 2, which is formulated at a ratio of (number).
マメ科に属する植物及び/またはマメ科に属する植物抽出物と、
タデに属する植物、タデに属する植物の抽出物からなる群より選ばれる少なくとも1種とを有効成分として含有することを特徴とする糖尿病治療剤。
Plants belonging to legumes and / or plant extracts belonging to legumes;
A therapeutic agent for diabetes, comprising as an active ingredient at least one selected from the group consisting of a plant belonging to a seed and an extract of a plant belonging to a seed.
マメ科に属する植物i重量部およびマメ科に属する植物抽出物j重量部(ここで、iおよびjはi+j=100の関係を満たす0以上の数)に対して、
タデ科に属する植物k重量部、タデ科に属する植物抽出物1重量部(ここで、kおよびlは、3≦k+l≦100の関係を満たす0以上の数)の割合で配合されていることを特徴とする請求項5に記載の糖尿病治療剤。
For i parts by weight of plants belonging to legumes and j parts by weight of plant extracts belonging to legumes (where i and j are 0 or more satisfying the relationship of i + j = 100),
It is blended at a ratio of k parts by weight of plants belonging to the family Taceae and 1 part by weight of plant extracts belonging to the family Taceae (where k and l are 0 or more satisfying the relationship 3 ≦ k + l ≦ 100). The diabetes therapeutic agent of Claim 5 characterized by these.
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