JP4524018B2 - Pharmaceutical composition and health food for prevention and treatment of non-insulin dependent diabetes mellitus comprising mulberry leaf and agaricus extract mixture - Google Patents
Pharmaceutical composition and health food for prevention and treatment of non-insulin dependent diabetes mellitus comprising mulberry leaf and agaricus extract mixture Download PDFInfo
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Description
【０００１】
【発明の属する技術分野】
本発明は、日常の食事を取りながら毎日簡単に摂取できる、桑の葉抽出物およびアガリクスの抽出物の混合物を含有するインスリン非依存型糖尿病（insulin non-independent diabetes mellitus:以下「ＮＩＤＤＭ」という）の予防、治療用の医薬組成物および健康食品に関する。
【０００２】
【従来の技術】
１９９４年に厚生省で行われた「糖尿病調査研究事業」の調査によると、我国における糖尿病患者は６００万人にのぼり、治療を受けていなくても糖尿病と疑われる「境界型」の人や潜在的糖尿病などの予備軍を含めると、１０００万人〜１２００万人に達するといわれている。特に、ＮＩＤＤＭは、糖尿病の９０％以上を占める。一般に高血糖状態は中年以降で発見され、高血糖状態が何年も続く場合が多く、一般に食事、運動療法が治療の基礎となる。
従って、日常の食事を取りながらも摂取できるＮＩＤＤＭの予防・治療薬が望まれる。
【０００３】
また、我国では糖尿病治療中の患者の４割強が経口血糖降下薬の投与を受けている。しかしながら、これらの経口血糖降下薬（特にスルホニル尿素剤＜ＳＵ剤＞、ピグアナイド剤、スルホンアミド剤）などは、造血器障害、肝機能障害、胃腸障害などの副作用が多く報告され、医師の指示なしでは服用が難しいのが現状である。
従って、長期的な服用を考慮した場合、副作用の面からも安全で安価なＮＩＤＤＭの予防・治療薬が待望される。
【０００４】
【発明が解決しようとする課題】
本発明の目的は、日常の食事を取りながらも簡単に摂取でき、かつ副作用の面からも安全なＮＩＤＤＭ予防、治療用の医薬組成物ないしは同様の効果を有する健康食品を提供することにある。
【０００５】
【課題を解決するための手段】
アガリクス（Agaricus blazei）は、ブラジル、サンパウロ州ピエダーテ市郊外で採取されたハラタケ科ハラタケ属のキノコである。近年、欧米および日本の癌研究者によりこのアガリクスの抗癌作用（抗腫瘍活性）が注目され、含有成分であるβ−Ｄ−グルカンなどの多糖類により免疫システムの活性化を介して抗癌作用を有することが明らかにされている。また、このアガリクスが糖尿病に対しても血糖降下作用を有することも知られている。
【０００６】
一方、桑は、クワ科に属する植物である。この桑の葉（Morus alba L.）はショ糖、果糖、ブドウ糖などの糖類、アスパラギン酸、グルタミン酸などのアミノ酸、各種ビタミンおよび亜鉛などの金属類を含有する。また、桑の葉は血糖降下作用を有し、糖尿病を予防する効果があることが知られており、昔から漢方薬として用いられている。
【０００７】
今回、本発明者らは、桑の葉抽出物とアガリクス抽出物とを混合することにより、意外にも相乗効果が奏され、それぞれ単独で使用するよりも、糖尿病に対してより効果的に作用することを見出し、本発明を完成するに至った。
【０００８】
すなわち、本発明は、桑の葉抽出物とアガリクス抽出物とを有効成分として含有するＮＩＤＤＭ予防、治療用の医薬組成物を提供するものである。
【０００９】
また、本発明は、桑の葉抽出物とアガリクス抽出物との混合物を含有してなる健康食品を提供するものである。
【００１０】
【発明の実施の形態】
以下、本発明の医薬組成物および健康食品を説明する。
【００１１】
本発明の医薬組成物および健康食品は、桑の葉抽出物とアガリクス抽出物との混合物を有効成分として含有する。
【００１２】
桑の葉抽出物は、乾燥後粉末化した桑の葉（以下、桑の葉「原生薬」という）を、沸騰水浴（９５〜１００℃）中で２〜１０分間、次いで熱水浴（６０〜８０℃）中で５〜２０分間加熱して、濾過し、濾液を濃縮する。所望により、濃縮エキスをさらに凍結乾燥することもできる。
一方、アガリクス抽出物も上記の桑の葉抽出物と同様の調製方法により、乾燥後粉末化したアガリクス（以下、アガリクス「原生薬」という）から出発して同様の抽出工程で得ることができる。なお、これらの桑の葉抽出物とアガリクス抽出物との混合物は、桑の葉「原生薬」およびアガリクス「原生薬」を混合した後、上記工程により調製することもできる。
【００１３】
上記で得られた桑の葉抽出物およびアガリクス抽出物を所望の比率で混合して、混合物を得ることができる。配合比は、相乗効果の観点より重量比でアガリクス抽出物：桑の葉抽出物＝１：３００〜３００：１の範囲が好ましい。
【００１４】
かかる混合物は錠剤化、顆粒化または液剤化して、錠剤分包品、顆粒分包品または液剤とすることができる。上記製剤化に際しては、例えば、錠剤化および顆粒化では、所望により、乳糖、デキストリン、デンプン、セルロースなどの慣用的な賦形剤を、液剤化では、所望により安定剤、保存剤などの慣用的な添加剤を使用することができる。別法として、適当な瓶（ガラス、缶、防湿ファイバー紙類）に充填することもできる。
【００１５】
本発明の医薬組成物に配合される桑の葉抽出物およびアガリクス抽出物の合計量は、１回服用量当たり３０〜３０００ｍｇの範囲である。
【００１６】
また、本発明の医薬組成物は、１錠当たりの桑の葉抽出物およびアガリクス抽出物の合計量が１０〜２５０ｍｇである錠剤の場合、３〜６錠／回を朝、昼、夕食の１日３回、食前に服用するのが好ましい。また、１包当たりの桑の葉抽出物およびアガリクス抽出物の合計量が５０〜２５０ｍｇである顆粒の場合、１〜６包／回を朝、昼、夕食の１日３回、食前に服用するのが好ましい。さらに、１ｍｌ製剤当たりの桑の葉抽出物およびアガリクス抽出物の合計量が５０〜２５０ｍｇである液剤の場合、１〜３ｍｌ／回を朝、昼、夕食の１日３回、食前に服用するのが好ましい。
【００１７】
なお、本発明の医薬組成物は、従来から人類が摂取してきた桑の葉およびアガリクスから得られる熱水抽出物であるので無毒である。
【００１８】
また、本発明の健康食品は、前記したごとくに得られる混合物と前記したごとき賦形剤、添加剤とで補助食品の形態（細粒化分包、固型丸粒、三角粒など）、あるいは水溶液中に再溶解してドリンク中に配合した形態とすることができる。
【００１９】
【実施例】
以下に、調製例および実施例を挙げて本発明をさらに詳しく説明するが、本発明はそれらに限定されるものではない。
【００２０】
調製例１ 桑の葉抽出物の調製
桑の葉を陰干しし、７０〜８５℃にて熱風乾燥し、蒸気滅菌を行なった後、５０〜７０℃にてさらに数時間乾燥した。乾燥した桑の葉を粉末化して１２０メッシュの桑の葉を得た。この桑の葉「原生薬」に５０ないし５００倍重量の蒸留水を添加した。これを沸騰水浴（９５℃）中で５分間、次いで熱水浴（７０℃）中で１０分間加熱し、定量用濾紙にて濾過した。この濾液を濃縮機（東京ＲＩＫＡＫＩＫＡＩ製）にて減圧下濃縮し、濃縮エキスを得た。次いで、これを凍結乾燥機（ＥＹＥＬＡ ＦＤＵ−５０６）によって凍結乾燥して、凍結乾燥物を得た。
【００２１】
調製例２ アガリクス抽出物の調製
アガリクスを陰干しし、７０〜８５℃にて熱風乾燥し、蒸気滅菌を行なった後、５０〜７０℃にてさらに数時間乾燥した。乾燥したアガリクスを粉末化して１２０メッシュのアガリクスを得た。このアガリクス「原生薬」に５０ないし５００倍重量の蒸留水を添加した。これを沸騰水浴（９５℃）中で５分間、次いで熱水浴（７０℃）中で１０分間加熱し、定量用濾紙にて濾過した。この濾液を濃縮機（東京ＲＩＫＡＫＩＫＡＩ製）にて減圧下濃縮し、濃縮エキスを得た。次いで、これを凍結乾燥機（ＥＹＥＬＡ ＦＤＵ−５０６）によって凍結乾燥して、凍結乾燥物を得た。
【００２２】
実施例１
調製例１で得られた桑の葉抽出物１００ｍｇ、調製例２で得られたアガリクス抽出物５０ｍｇ、還元麦芽糖水飴３０ｍｇ、デキストリン５ｍｇおよびグリセリン脂肪酸エステル１５ｍｇを混合し、造粒、乾燥および１６メッシュにて篩過した後、常法に従って錠剤形態（六角錠、丸錠または三角錠）の本発明の医薬組成物を得た。
【００２３】
実施例２
調製例１で得られた桑の葉抽出物１００ｍｇ、調製例２で得られたアガリクス抽出物５０ｍｇ、還元麦芽糖水飴３０ｍｇ、デキストリン５ｍｇおよびグリセリン脂肪酸エステル１５ｍｇを混合し、造粒、乾燥および１６メッシュにて篩過した後、常法に従って錠剤形態（六角錠、丸錠または三角錠）の本発明の健康食品を得た。
【００２４】
実施例３
調製例１で得られた桑の葉抽出物１００ｍｇ、調製例２で得られたアガリクス抽出物５０ｍｇ、デキストリン３８ｍｇおよびリン酸三カルシウム１２ｍｇを混合し、造粒、乾燥および１６〜８０メッシュにて篩過した後、常法に従って顆粒化して顆粒剤形態の本発明の医薬組成物を得た。
【００２５】
実施例４
調製例１で得られた桑の葉抽出物１００ｍｇ、調製例２で得られたアガリクス抽出物５０ｍｇ、デキストリン３８ｍｇおよびリン酸三カルシウム１２ｍｇを混合し、造粒、乾燥および１６〜８０メッシュにて篩過した後、常法に従って顆粒化して顆粒剤形態の本発明の健康食品を得た。
【００２６】
実施例５
調製例１で得られた桑の葉抽出物１００ｍｇおよび調製例２で得られたアガリクス抽出物５０ｍｇの混合物を１ｍｌの蒸留水に再溶解し、スポイド付き３０ｍｌ用ガラス製瓶に充填し、液剤化して液剤形態の本発明の医薬組成物を得た。
【００２７】
実施例６
調製例１で得られた桑の葉抽出物１００ｍｇおよび調製例２で得られたアガリクス抽出物５０ｍｇの混合物を１ｍｌの蒸留水に再溶解し、スポイド付き３０ｍｌ用ガラス製瓶に充填し、液剤化して液剤形態の本発明の健康食品を得た。
【００２８】
本発明の医薬組成物の糖尿病に対する効果の試験
本試験において、食餌中に添加することにより、調製例１で得られた桑の葉抽出物、調製例２で得られたアガリクス抽出物またはこれらの混合物を自然発症糖尿病マウス（ＫＫ−Ａyマウス）に投与して、桑の葉抽出物および／またはアガリクス抽出物の血糖値の改善効果を検討した。
このＫＫ−Ａyマウスは、７〜８週齢で重度な肥満・高血糖を発現することから、糖尿病患者の大多数を占めるＮＩＤＤＭの発症機構の解明の研究に用いられ、特に、抗糖尿病薬のスクリーニングに適した病態モデル動物である。
かかるＮＩＤＤＭモデルマウスに対しての糖代謝改善効果は以下の通りである。なお、試験データは、一元配置分散分析により統計処理を実施し、Ｔｕｋｅｙの多重比較にて有意差検定を行なった。
【００２９】
１．実験方法
１） ＮＩＤＤＭモデルマウスの飼育条件
５週齢のＫＫ−Ａy系雄マウスを購入し、予備飼育を行なった。その後、空腹時採血での血糖値を測定し、各群の実験開始時の血糖値がほぼ均一となるようにマウスを４群に区分けした。
実験食としてのＡＩＮ−７６飼料を基本ベースに、コントロール群（Ａ群:６匹）、桑５％投与群（Ｂ群:６匹）、桑５％＋アガリクス５％投与群（Ｃ群:６匹）およびアガリクス５％投与群（Ｄ群:６匹）に分けて実験を実施した。７８日間の実験期間中、マウスは室温２２±２℃、１２時間の明暗サイクル（７：００〜１９：００）条件下、プラスチックケージ中で単独飼育し、餌と飲料水は自由摂取させた。
【００３０】
２） 実験飼料の調製
本実験において、タンパク質源としてミルクカゼインを用いた。桑および／またはアガリクス投与群（Ｂ、ＣおよびＤ群）においては、飼料中に配合する桑および／またはアガリクス抽出物の添加量をコーンスターチ量から差し引くことにより調整した。表１に実験用飼料の組成を示した。
【００３１】
【表１】
３） 飼料群・動物数
表２に、飼料群および動物数を示す。
【００３３】
【表２】
４） 糖負荷試験
飼料摂取開始後１０週目に、臨床試験で頻繁に使用されている糖負荷試験を行なって耐糖能を調べた。糖負荷条件は以下の通りである。
マウスを２４時間絶食させた後、可溶性デンプンを２g/kg体重にて経口投与した。投与前および投与後３０、６０、１２０および１８０分に尾静脈より採血し、小型血糖測定器グルテスト（（株）京都第一科学製）を用い、酵素電極法によって血糖値を測定した。
【００３５】
２．実験結果
実験結果を表３および図１に示す。
表３は、飼料摂取開始後１０週目における可溶性デンプンの投与前および投与後３０、６０、１２０および１８０分の血糖値の測定結果である。また、図１は、血糖値の経時変化を示すグラフである。
桑／アガリクス共投与群（Ｃ群）は、桑単独投与群（Ｂ群）およびアガリクス単独投与群（Ｄ群）よりも、投与後３０、６０および１２０分の血糖値を抑制することが明らかとなった。特に、可溶性デンプンは、穀類、芋類、豆類などの多くの豆類の主成分であることから、桑／アガリクス共投与による相乗的な血糖値抑制効果は、糖尿病の予防および治療に対して有意義なものと考えられる。
【００３６】
【表３】
以上の結果、桑の葉抽出物とアガリクス抽出物との混合物は、各々、単独で摂取した場合より、優れた血糖値の改善効果をもたらした。すなわち、桑の葉抽出物中に含まれていると考えられる有効成分によるα−グルコシダーゼの阻害効果と、アガリクス抽出物に含まれていると考えられるβ−Ｄ−グルカンなどの有効成分による免疫力を高めインスリンの働きを正常化する効果との相乗効果が明らかになり、その医薬組成物および健康食品が糖尿病改善に非常に有効で、かつ安全で理想的な組成物であることが判明した。
【００３８】
【発明の効果】
本発明により、ＮＩＤＤＭの治療に効果的で、日常の食事を取りながらも簡単に摂取でき、かつ副作用の面からも安全な医薬組成物および健康食品が提供される。
【図面の簡単な説明】
【図１】 飼料摂取開始後１０週目において可溶性デンプンを負荷した際の血糖値の経時変化を示すグラフである。[0001]
BACKGROUND OF THE INVENTION
The present invention relates to insulin non-independent diabetes mellitus (hereinafter referred to as “NIDDM”) containing a mixture of mulberry leaf extract and agaricus extract that can be easily ingested daily while taking a daily meal. The present invention relates to a pharmaceutical composition and a health food for the prevention and treatment of cancer.
[0002]
[Prior art]
According to the “Diabetes Research Project” conducted in 1994 by the Ministry of Health and Welfare, there are 6 million diabetic patients in Japan. Including reserves such as diabetes, it is said to reach 10 million to 12 million. In particular, NIDDM accounts for over 90% of diabetes. In general, a hyperglycemic state is discovered after middle age, and the hyperglycemic state often lasts for many years. In general, diet and exercise therapy are the basis of treatment.
Therefore, a prophylactic / therapeutic drug for NIDDM that can be ingested while taking a daily meal is desired.
[0003]
In Japan, more than 40% of patients undergoing treatment for diabetes receive oral hypoglycemic drugs. However, these oral hypoglycemic drugs (especially sulfonylurea <SU>, piganaides, sulfonamides) have been reported to have many side effects such as hematopoietic disorders, liver dysfunction, gastrointestinal disorders, etc. Now, it is difficult to take.
Therefore, when taking long-term use, a safe and inexpensive preventive / therapeutic drug for NIDDM is also expected from the viewpoint of side effects.
[0004]
[Problems to be solved by the invention]
An object of the present invention is to provide a pharmaceutical composition for prevention and treatment of NIDDM or a health food having the same effect that can be easily ingested while taking a daily meal and is safe from the side effects.
[0005]
[Means for Solving the Problems]
Agaricus (Agaricus blazei) is a mushroom belonging to the genus Agaricaceae collected in the suburb of Piedate, Sao Paulo, Brazil. In recent years, anticancer activity (antitumor activity) of Agaricus has attracted attention by cancer researchers in Europe and the United States and Japan, and anticancer activity is achieved through activation of the immune system by polysaccharides such as β-D-glucan as a component. Has been shown to have It is also known that this Agaricus has a hypoglycemic action against diabetes.
[0006]
On the other hand, mulberry is a plant belonging to the mulberry family. This mulberry leaf (Morus alba L.) contains sugars such as sucrose, fructose and glucose, amino acids such as aspartic acid and glutamic acid, various vitamins and metals such as zinc. Mulberry leaves are known to have a hypoglycemic action and have an effect of preventing diabetes, and have been used as a traditional Chinese medicine.
[0007]
This time, the present inventors surprisingly have a synergistic effect by mixing the mulberry leaf extract and the agaricus extract, acting more effectively on diabetes than using each alone. As a result, the present invention has been completed.
[0008]
That is, the present invention provides a pharmaceutical composition for preventing and treating NIDDM, which contains a mulberry leaf extract and an agaricus extract as active ingredients.
[0009]
The present invention also provides a health food comprising a mixture of mulberry leaf extract and agaricus extract.
[0010]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, the pharmaceutical composition and health food of the present invention will be described.
[0011]
The pharmaceutical composition and health food of the present invention contain a mixture of mulberry leaf extract and agaricus extract as an active ingredient.
[0012]
The mulberry leaf extract is prepared by drying powdered mulberry leaves (hereinafter referred to as mulberry leaves “raw drug substance”) in a boiling water bath (95-100 ° C.) for 2 to 10 minutes, followed by a hot water bath (60 Heat at ˜80 ° C. for 5-20 minutes, filter and concentrate the filtrate. If desired, the concentrated extract can be further lyophilized.
On the other hand, an agaricus extract can be obtained in the same extraction step by starting from agaricus powdered after drying (hereinafter referred to as agaricus “pure drug”) by the same preparation method as the above mulberry leaf extract. The mixture of the mulberry leaf extract and the agaricus extract can also be prepared by the above-mentioned process after mixing the mulberry leaf “raw drug” and the agaricus “pure drug”.
[0013]
The mulberry leaf extract and agaricus extract obtained above can be mixed at a desired ratio to obtain a mixture. The blending ratio is preferably in the range of Agaricus extract: Mulberry leaf extract = 1: 300 to 300: 1 in terms of weight ratio from the viewpoint of synergistic effect.
[0014]
Such a mixture can be tableted, granulated or liquefied to form a tablet sachet, granule sachet or liquid. In the above formulation, for example, in tableting and granulating, if necessary, conventional excipients such as lactose, dextrin, starch, and cellulose are used. In liquid formulation, if necessary, conventional stabilizers, preservatives, and the like are used. Various additives can be used. Alternatively, suitable bottles (glass, cans, moisture-proof fiber papers) can be filled.
[0015]
The total amount of mulberry leaf extract and agaricus extract blended in the pharmaceutical composition of the present invention is in the range of 30 to 3000 mg per dose.
[0016]
In addition, in the case of a tablet in which the total amount of mulberry leaf extract and agaricus extract per tablet is 10 to 250 mg, the pharmaceutical composition of the present invention is 3 to 6 tablets / dose in the morning, noon and dinner. It is preferable to take 3 times a day before meals. In the case of granules in which the total amount of mulberry leaf extract and agaricus extract per packet is 50 to 250 mg, take 1 to 6 packets / time three times a day in the morning, noon and dinner before meals. Is preferred. Furthermore, in the case of a liquid preparation in which the total amount of mulberry leaf extract and agaricus extract per 1 ml preparation is 50 to 250 mg, take 1 to 3 ml / times 3 times a day in the morning, noon and dinner before meals. Is preferred.
[0017]
The pharmaceutical composition of the present invention is non-toxic because it is a hot water extract obtained from mulberry leaves and agaricus that have been ingested by humans.
[0018]
Further, the health food of the present invention is a supplementary food form (finely divided sachet, solid round grain, triangular grain, etc.) composed of the mixture obtained as described above and the excipients and additives as mentioned above, or It can be made into the form mix | blended in drink by re-dissolving in aqueous solution.
[0019]
【Example】
Hereinafter, the present invention will be described in more detail with reference to Preparation Examples and Examples, but the present invention is not limited thereto.
[0020]
Preparation Example 1 Preparation of Mulberry Leaf Extract Mulberry leaves were shade-dried, dried with hot air at 70 to 85 ° C., steam sterilized, and further dried at 50 to 70 ° C. for several hours. The dried mulberry leaves were pulverized to obtain 120 mesh mulberry leaves. Distilled water having a weight of 50 to 500 times was added to this mulberry leaf “raw drug”. This was heated in a boiling water bath (95 ° C.) for 5 minutes, then in a hot water bath (70 ° C.) for 10 minutes, and filtered through a quantitative filter paper. The filtrate was concentrated under reduced pressure using a concentrator (manufactured by Tokyo Rikakikai) to obtain a concentrated extract. Then, this was freeze-dried by a freeze dryer (EYELA FDU-506) to obtain a freeze-dried product.
[0021]
Preparation Example 2 Preparation of Agaricus Extract Agaricus was shade-dried, dried with hot air at 70 to 85 ° C., steam sterilized, and further dried at 50 to 70 ° C. for several hours. The dried agarics were pulverized to obtain 120 mesh agarics. Distilled water having a weight of 50 to 500 times was added to the Agaricus “Drug Substance”. This was heated in a boiling water bath (95 ° C.) for 5 minutes, then in a hot water bath (70 ° C.) for 10 minutes, and filtered through a quantitative filter paper. The filtrate was concentrated under reduced pressure using a concentrator (manufactured by Tokyo Rikakikai) to obtain a concentrated extract. Then, this was freeze-dried by a freeze dryer (EYELA FDU-506) to obtain a freeze-dried product.
[0022]
Example 1
100 mg of mulberry leaf extract obtained in Preparation Example 1, 50 mg of Agaricus extract obtained in Preparation Example 2, 30 mg of reduced maltose starch syrup, 5 mg of dextrin and 15 mg of glycerol fatty acid ester are mixed, granulated, dried and made into 16 mesh. After sieving, the pharmaceutical composition of the present invention in the form of a tablet (hexagonal tablet, round tablet or triangular tablet) was obtained according to a conventional method.
[0023]
Example 2
100 mg of mulberry leaf extract obtained in Preparation Example 1, 50 mg of Agaricus extract obtained in Preparation Example 2, 30 mg of reduced maltose starch syrup, 5 mg of dextrin and 15 mg of glycerol fatty acid ester are mixed, granulated, dried and made into 16 mesh. After sieving, the health food of the present invention in the form of a tablet (hexagonal tablet, round tablet or triangular tablet) was obtained according to a conventional method.
[0024]
Example 3
100 mg of mulberry leaf extract obtained in Preparation Example 1, 50 mg of Agaricus extract obtained in Preparation Example 2, 38 mg of dextrin and 12 mg of tricalcium phosphate are mixed, granulated, dried and sieved through 16-80 mesh. Then, it was granulated according to a conventional method to obtain a pharmaceutical composition of the present invention in the form of granules.
[0025]
Example 4
100 mg of mulberry leaf extract obtained in Preparation Example 1, 50 mg of Agaricus extract obtained in Preparation Example 2, 38 mg of dextrin and 12 mg of tricalcium phosphate are mixed, granulated, dried and sieved through 16-80 mesh. Then, it was granulated according to a conventional method to obtain the health food of the present invention in the form of granules.
[0026]
Example 5
A mixture of 100 mg of the mulberry leaf extract obtained in Preparation Example 1 and 50 mg of the Agaricus extract obtained in Preparation Example 2 was redissolved in 1 ml of distilled water, filled into a 30 ml glass bottle with a spoid, and liquefied. Thus, a pharmaceutical composition of the present invention in a liquid form was obtained.
[0027]
Example 6
A mixture of 100 mg of the mulberry leaf extract obtained in Preparation Example 1 and 50 mg of the Agaricus extract obtained in Preparation Example 2 was redissolved in 1 ml of distilled water, filled into a 30 ml glass bottle with a spoid, and liquefied. Thus, the health food of the present invention in a liquid form was obtained.
[0028]
In this test, the mulberry leaf extract obtained in Preparation Example 1, the agaricus extract obtained in Preparation Example 2 or these were added by adding to the diet in this test. The mixture was administered to spontaneously diabetic mice (KK-A y mice), and the effect of improving the blood glucose level of mulberry leaf extract and / or agaricus extract was examined.
Since this KK-A y mouse develops severe obesity and hyperglycemia at 7-8 weeks of age, it is used for research on elucidation of the onset mechanism of NIDDM, which accounts for the majority of diabetic patients. It is a disease model animal suitable for screening.
The effect of improving glucose metabolism for such NIDDM model mice is as follows. The test data were statistically processed by one-way analysis of variance and tested for significance by Tukey's multiple comparison.
[0029]
1. Experimental Method 1) Breeding conditions for NIDDM model mice 5-week-old KK-A y male mice were purchased and preliminarily reared. Thereafter, the blood glucose level in fasting blood sampling was measured, and the mice were divided into 4 groups so that the blood glucose level at the start of each group was almost uniform.
Based on AIN-76 feed as experimental food, control group (Group A: 6 animals),
[0030]
2) Preparation of experimental feed In this experiment, milk casein was used as a protein source. In the mulberry and / or agaricus administration groups (groups B, C, and D), the amount of mulberry and / or agaricus extract added to the feed was adjusted by subtracting from the corn starch amount. Table 1 shows the composition of the experimental feed.
[0031]
[Table 1]
3) Feed group / animal number Table 2 shows the feed group and the number of animals.
[0033]
[Table 2]
4) Glucose tolerance test At 10 weeks after the start of feed intake, a glucose tolerance test frequently used in clinical trials was conducted to examine glucose tolerance. The sugar loading conditions are as follows.
Mice were fasted for 24 hours and then soluble starch was orally administered at 2 g / kg body weight. Blood was collected from the tail vein before administration and at 30, 60, 120 and 180 minutes after administration, and the blood glucose level was measured by an enzyme electrode method using a small blood glucose meter Glutest (manufactured by Kyoto Daiichi Kagaku Co., Ltd.).
[0035]
2. Experimental Results The experimental results are shown in Table 3 and FIG.
Table 3 shows the blood glucose measurement results before and after administration of soluble starch at 10 weeks after the start of feed intake. FIG. 1 is a graph showing a change in blood glucose level over time.
It is clear that the mulberry / agaricus co-administration group (group C) suppresses blood glucose levels at 30, 60 and 120 minutes after administration more than the mulberry single administration group (group B) and the agaricus single administration group (group D). became. In particular, since soluble starch is the main component of many beans such as cereals, potatoes, and beans, the synergistic blood glucose level inhibitory effect by co-administration of mulberry / Agaricus is significant for the prevention and treatment of diabetes. It is considered a thing.
[0036]
[Table 3]
As a result of the above, the mixture of the mulberry leaf extract and the agaricus extract each had a better blood glucose level improving effect than when it was ingested alone. That is, the inhibitory effect of α-glucosidase by the active ingredient considered to be contained in the mulberry leaf extract, and the immunity by the active ingredient such as β-D-glucan considered to be contained in the agaricus extract As a result, the pharmaceutical composition and the health food were found to be very effective, safe and ideal for improving diabetes.
[0038]
【The invention's effect】
INDUSTRIAL APPLICABILITY According to the present invention, there are provided a pharmaceutical composition and a health food that are effective in treating NIDDM, can be easily taken while taking a daily meal, and are safe from the side effects.
[Brief description of the drawings]
FIG. 1 is a graph showing changes in blood glucose level over time when soluble starch is loaded 10 weeks after the start of feed intake.
Claims (2)
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|---|---|---|---|
| JP2000018771A JP4524018B2 (en) | 2000-01-27 | 2000-01-27 | Pharmaceutical composition and health food for prevention and treatment of non-insulin dependent diabetes mellitus comprising mulberry leaf and agaricus extract mixture |
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| JP2000018771A JP4524018B2 (en) | 2000-01-27 | 2000-01-27 | Pharmaceutical composition and health food for prevention and treatment of non-insulin dependent diabetes mellitus comprising mulberry leaf and agaricus extract mixture |
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| KR100781817B1 (en) | 2006-02-17 | 2007-12-04 | 경상대학교산학협력단 | Freeze Dryed Material, Ethanol Precipitates, Ethylacetate Fraction of Agaricus Blazei Mushroom Mycelia and Manufacturing Process Thereof |
| JP4171819B2 (en) * | 2006-03-24 | 2008-10-29 | 島根県 | Method for producing dried plant extract |
| JP6638123B1 (en) | 2019-05-29 | 2020-01-29 | サントリーホールディングス株式会社 | Beverage containing 1-deoxynojirimycin |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH09140351A (en) * | 1995-11-21 | 1997-06-03 | Lotte Co Ltd | Eating and drinking composition for improving blood sugar |
| JPH10265397A (en) * | 1997-03-25 | 1998-10-06 | Toyotama Kenko Shokuhin Kk | Agent for preventing obesity |
| JPH1180014A (en) * | 1997-09-11 | 1999-03-23 | Okinawa Hakko Kagaku:Kk | Hypoglycemic agent containing agaricus blazei extract as active ingredient |
| JPH11187844A (en) * | 1997-12-26 | 1999-07-13 | Shingo Kikuchi | Food obtained by mixing bamboo glass and powder of agaicus blazei or extract thereof |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH09140351A (en) * | 1995-11-21 | 1997-06-03 | Lotte Co Ltd | Eating and drinking composition for improving blood sugar |
| JPH10265397A (en) * | 1997-03-25 | 1998-10-06 | Toyotama Kenko Shokuhin Kk | Agent for preventing obesity |
| JPH1180014A (en) * | 1997-09-11 | 1999-03-23 | Okinawa Hakko Kagaku:Kk | Hypoglycemic agent containing agaricus blazei extract as active ingredient |
| JPH11187844A (en) * | 1997-12-26 | 1999-07-13 | Shingo Kikuchi | Food obtained by mixing bamboo glass and powder of agaicus blazei or extract thereof |
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