JP2012201593A - Composition for preventing, ameliorating or treating diabetic fatty liver - Google Patents

Composition for preventing, ameliorating or treating diabetic fatty liver Download PDF

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JP2012201593A
JP2012201593A JP2011064390A JP2011064390A JP2012201593A JP 2012201593 A JP2012201593 A JP 2012201593A JP 2011064390 A JP2011064390 A JP 2011064390A JP 2011064390 A JP2011064390 A JP 2011064390A JP 2012201593 A JP2012201593 A JP 2012201593A
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fatty liver
extract
liver
carrot
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Kazuma Yoshizumi
一真 吉積
Chihiro Kato
千尋 加藤
Masaru Ochiai
優 落合
Chiaki Okuda
千晶 奥田
Masayoshi Yamada
昌良 山田
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Fancl Corp
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Abstract

PROBLEM TO BE SOLVED: To provide a composition for preventing, ameliorating or treating diabetic fatty liver.SOLUTION: The composition for preventing, ameliorating or treating diabetic fatty liver comprises an extract of Vitex agnus castus. Preferably, the extract of Vitex agnus castus is an extract of a fruit of Vitex agnus castus.

Description

本発明は、糖尿病性脂肪肝の予防、改善、または治療用組成物に関する。   The present invention relates to a composition for preventing, improving or treating diabetic fatty liver.

一般的な脂肪肝を始め、非アルコール性脂肪肝炎(NASH)、過栄養性脂肪肝、糖尿病性脂肪肝、アルコール性脂肪肝または中毒性脂肪肝などの、肝臓中に脂肪が異常に蓄積する疾患を呈する患者は年々増加しており、なかでも非アルコール性脂肪肝炎(NASH)は、重篤な病状を示すとして特に問題視されている(非特許文献1)。さらに、肝臓への異常な脂肪蓄積は、肝臓の炎症や肝臓の繊維化(肝硬変)を引き起こしたり、肝癌等の重篤な疾患へ移行することが指摘されており、この脂肪蓄積を抑制することは極めて重要である。   Diseases in which fat accumulates abnormally in the liver, such as general fatty liver, nonalcoholic steatohepatitis (NASH), hypertrophic fatty liver, diabetic fatty liver, alcoholic fatty liver or toxic fatty liver The number of patients presenting is increasing year by year, and nonalcoholic steatohepatitis (NASH) is especially regarded as a serious problem as a serious medical condition (Non-patent Document 1). Furthermore, it has been pointed out that abnormal fat accumulation in the liver causes inflammation of the liver and fibrosis of the liver (cirrhosis) and shifts to serious diseases such as liver cancer. Is extremely important.

肝臓への脂肪蓄積は、近年の生活様式の変化をはじめとする様々な要因が相互に重なり合い、肝臓におけるエネルギー代謝に異常をきたした結果引き起こされると考えられており、そのためその治療方法は一様ではない。現在、肝臓への脂肪蓄積を改善する方法としては、食餌療法、運動療法、薬物療法などが試行されているが、これらの方法は、コントロールや継続的な実施が困難であるために、必ずしも満足のいく治療効果が得られない場合も多い。一方、薬物療法においてはポリエンフォスファチジルコリン製剤が脂肪肝に対して保険適用となっているのみである。以上のように、肝臓への脂肪蓄積に対してはまだ十分な処置方法が確立されておらず、脂肪蓄積に対してより有効性の高い薬剤の開発が嘱望されている。   The accumulation of fat in the liver is thought to be caused by various factors, including changes in lifestyles in recent years, that are caused by abnormalities in energy metabolism in the liver. is not. At present, dietary therapy, exercise therapy, drug therapy, etc. have been tried as methods for improving fat accumulation in the liver, but these methods are not always satisfactory because they are difficult to control and continuously perform. In many cases, the therapeutic effect is not obtained. On the other hand, in pharmacotherapy, polyemphosphatidylcholine preparations are only covered by insurance against fatty liver. As described above, a sufficient treatment method has not yet been established for fat accumulation in the liver, and development of a drug that is more effective for fat accumulation is desired.

糖尿病は、多飲、多尿、体重減少などの症状、慢性の高血糖を主な特徴とし、一般的に、網膜症、腎症、末梢神経障害などの合併症を伴う疾患である。糖尿病は、その病因により、インスリン依存性糖尿病(I型糖尿病)、インスリン非依存性糖尿病(II型糖尿病)、二次性糖尿病(膵臓性糖尿病、膵外性/内分泌性糖尿病、薬剤誘発性糖尿病)などに分類されている。糖尿病は、血糖値の上昇を伴い、これにより血管系の脆弱性をもたらし、心筋梗塞、脳梗塞などの動脈硬化性疾患、失明や抹消血管の塞栓など種々の疾患の危険因子となることが知られている。さらに糖尿病では、インスリンの分泌の低下により、肝臓で中性脂肪が多く生みだされることで、脂肪肝が発生しやすくなるといわれている。更に脂肪肝は耐糖能を低下させ、糖尿病を悪化させる。この悪循環により患者の症状は悪化してゆく。糖尿病性脂肪肝の治療においては、血糖降下剤の使用が検討されている。しかしながら、血糖低下作用を有する糖尿病治療薬、例えばトルブタミドは、肝臓への脂肪蓄積を抑制する効果を発揮しないこと(非特許文献2を参照)や、逆に肝臓への脂肪蓄積を増悪させるおそれがあることも指摘されており、脂肪肝に対する有用性は確認されていない。   Diabetes is mainly characterized by symptoms such as polydipsia, polyuria, weight loss, and chronic hyperglycemia, and is generally a disease accompanied by complications such as retinopathy, nephropathy, and peripheral neuropathy. Depending on the pathogenesis of diabetes, insulin-dependent diabetes (type I diabetes), non-insulin-dependent diabetes (type II diabetes), secondary diabetes (pancreatic diabetes, extrapancreatic / endocrine diabetes, drug-induced diabetes) It is classified as such. Diabetes is associated with an increase in blood glucose level, which causes vascular fragility and is a risk factor for various diseases such as arteriosclerotic diseases such as myocardial infarction and cerebral infarction, blindness and peripheral blood vessel embolism. It has been. Furthermore, in diabetes, it is said that fatty liver is likely to occur because a lot of neutral fat is produced in the liver due to a decrease in insulin secretion. Furthermore, fatty liver reduces glucose tolerance and exacerbates diabetes. This vicious circle will exacerbate the patient's symptoms. In the treatment of diabetic fatty liver, the use of hypoglycemic agents has been studied. However, antidiabetic drugs having a hypoglycemic effect, such as tolbutamide, do not exert an effect of suppressing the accumulation of fat in the liver (see Non-Patent Document 2), and conversely, the accumulation of fat in the liver may be exacerbated. It has also been pointed out that its usefulness for fatty liver has not been confirmed.

また、高脂血症治療剤であるクロフィブレートは、血中の中性脂肪やコレステロールを低下させる一方、肝臓への脂肪蓄積という副作用を引き起こすことが報告されている(特許文献1)。更に、高脂血症治療剤であるミクロソームトリグリセライド転送蛋白阻害薬においても、血中の中性脂肪やコレステロールを低下させるものの、肝臓への脂肪蓄積を誘発することが報告されている(特許文献2を参照)。以上の通り、これらの高脂血症治療薬においては、血中と肝臓での中性脂肪やコレステロールの量には相間が認められない上に、脂肪肝を誘発する場合も観察されている。このような観点から糖尿病性脂肪肝の予防治療に有効な化合物が多数提案されている(特許文献3)が、副作用の問題などが必ずしも解決できていない。   In addition, clofibrate, which is a therapeutic agent for hyperlipidemia, has been reported to cause a side effect of fat accumulation in the liver while lowering blood neutral fat and cholesterol (Patent Document 1). Furthermore, a microsomal triglyceride transfer protein inhibitor, which is a therapeutic agent for hyperlipidemia, has also been reported to induce fat accumulation in the liver, although it lowers blood neutral fat and cholesterol (Patent Document 2). See). As described above, in these drugs for treating hyperlipidemia, there is no correlation between the amount of neutral fat and cholesterol in the blood and liver, and cases of inducing fatty liver have been observed. From this point of view, many compounds effective for the prevention and treatment of diabetic fatty liver have been proposed (Patent Document 3), but the problem of side effects and the like cannot always be solved.

セイヨウニンジンボク(学名 Vitex agnus-castus)はチェストツリーとも呼ばれている地中海や中央アジアに広く自生している植物で、この植物の果実はチェストベリーとよばれており、黄体ホルモン様の作用を有しており、そのまま、或いは水やアルコール抽出物が女性の月経不順などの治療に広く用いられている。また安全性が高く、副作用の心配が殆どないとも言われている(非特許文献3参照)。   The carrot box (scientific name Vitex agnus-castus) is a plant that grows naturally in the Mediterranean and Central Asia, also called the chest tree. The fruit of this plant is called chestnut and has a progesterone-like action. As it is, water and alcohol extracts are widely used for treating menstrual irregularities in women. It is also said that the safety is high and there is almost no worry about side effects (see Non-Patent Document 3).

特開平8−119860号公報JP-A-8-11860 特開2002−220345号公報JP 2002-220345 A 国際公開第2006/002237号International Publication No. 2006/002237

石井裕正,「医学のあゆみ」,2003年,第206巻,第5号,p.323−325Hiromasa Ishii, “Ayumi of Medicine”, 2003, 206, No. 5, p. 323-325 岩村健一郎,「最新医学」,1978年,第33巻,第3号,p.524−531Kenichiro Iwamura, “Latest Medicine”, 1978, Vol. 33, No. 3, p. 524-531 キャサリン・E・ウルブリヒト他編、渡邊昌 他監修、ハーブ&サプリメント486−493ページ(2007年1月10日発行)産調出版Supervised by Katherine E. Ulbricht and others, Masaru Watanabe and others, Herbs & Supplements 486-493 (issued January 10, 2007)

本発明は、副作用などの問題が生じにくく、安全性の高い糖尿病性脂肪肝の予防、改善または治療用組成物を提供することにある。   An object of the present invention is to provide a highly safe composition for preventing, improving or treating diabetic fatty liver, which is unlikely to cause problems such as side effects.

本発明者らは糖尿病の治療方法を研究する過程で、上記のセイヨウニンジンボクに強い糖尿病性脂肪肝の予防、改善又は治療効果を有することを発見し、本発明を完成するに至った。
従って、本発明は、
(1)セイヨウニンジンボクエキスを含有する糖尿病性脂肪肝の予防、改善または治療用組成物。
(2)セイヨウニンジンボクエキスがセイヨウニンジンボク果実エキスである(1)記載の組成物。
(3)上記(1)又は(2)記載の組成物を含有する医薬。
(4)上記(1)又は(2)記載の組成物を含有する健康食品。
を提供するところにある。
In the course of studying a method for treating diabetes, the present inventors have found that the above carrot carrot has a strong preventive, ameliorating or therapeutic effect on diabetic fatty liver, and completed the present invention.
Therefore, the present invention
(1) A composition for the prevention, amelioration or treatment of diabetic fatty liver containing carrot extract.
(2) The composition according to (1), wherein the carrot extract is a carrot fruit extract.
(3) A medicament comprising the composition according to (1) or (2) above.
(4) A health food containing the composition according to (1) or (2) above.
Is to provide.

本発明により、投与による副作用などの問題が生じにくく、安全性の高い糖尿病性脂肪肝の予防、改善または治療用組成物を提供することができる。   According to the present invention, it is possible to provide a highly safe composition for preventing, improving or treating diabetic fatty liver, which is unlikely to cause problems such as side effects due to administration.

本発明組成物を投与又は非投与の糖尿病性脂肪肝モデル動物の血漿GOTを測定した結果を示す図である。なお、図面中のVAはセイヨウニンジンボクエキスの学名からの略称である。It is a figure which shows the result of having measured the plasma GOT of the diabetic fatty liver model animal to which this invention composition is administered or not. In the drawings, VA is an abbreviation from the scientific name of carrot extract. 本発明組成物を投与又は非投与の糖尿病性脂肪肝モデル動物の血漿GPTを測定した結果を示すグラフである。It is a graph which shows the result of having measured the plasma GPT of the diabetic fatty liver model animal which administers or does not administer this invention composition. 本発明組成物を投与又は非投与の糖尿病性脂肪肝モデル動物の肝臓トリグリセリド測定結果を示すグラフである。It is a graph which shows the liver triglyceride measurement result of the diabetic fatty liver model animal to which this invention composition is administered or not. 本発明組成物を投与又は非投与の糖尿病性脂肪肝モデル動物の肝臓コレステロールの測定結果を示すグラフである。It is a graph which shows the measurement result of the liver cholesterol of the diabetic fatty liver model animal which administers or does not administer this invention composition.

本発明者らは、上述のとおり、セイヨウニンジンボクエキスに顕著な糖尿病性脂肪肝の予防、改善または治療作用を有することを見出し、本発明を完成した。   As described above, the present inventors have found that the carrot extract has a remarkable preventive, ameliorating or therapeutic action for diabetic fatty liver, and completed the present invention.

すなわち、本発明の組成物は、セイヨウニンジンボクエキスを含有することを一つの特徴とする。また本発明においては、セイヨウニンジンボクエキスの別名としてチェストツリーエキス、チェストベリーエキス、アグニエキスを使用することがある。   That is, the composition of the present invention is characterized by containing a carrot extract. In the present invention, chestnut tree extract, chestnut berry extract, and Agni extract may be used as aliases for carrot extract.

本発明の組成物は、I型糖尿病またはII型糖尿病のいずれの糖尿病由来の脂肪肝の予防、改善または治療に利用可能である。   The composition of the present invention can be used for prevention, amelioration or treatment of fatty liver derived from diabetes of either type I diabetes or type II diabetes.

本発明に用いられるセイヨウニンジンボクエキスは上述したとおり、古くから食経験があり、また月経不順の治療に使用され、さらに安全性が明らかにされている水又はアルコール抽出物が好ましい。したがって服用に際して副作用のリスクが少ない。   As described above, the carrot extract used in the present invention is preferably a water or alcohol extract that has been eaten for a long time and has been used for the treatment of irregular menstruation and whose safety has been clarified. Therefore, there is little risk of side effects when taking.

本発明において、セイヨウニンジンボクエキスとしては、市販のエキスであっても使用可能であり、また本発明の目的で水又は50%エタノールなどの溶媒で抽出しても良い。抽出液は、加熱乾燥や噴霧乾燥など公知の方法で乾燥させることができる。また乾燥工程においてデキストリンなどの粉末化助剤を併用することができる。市販のセイヨウニンジンボクエキスはアグヌサイド、アウクビン、カスチシンなどのプロラクチン様活性成分を含有している。   In the present invention, the carrot extract can be a commercially available extract, or may be extracted with a solvent such as water or 50% ethanol for the purpose of the present invention. The extract can be dried by a known method such as heat drying or spray drying. Moreover, powdering aids, such as dextrin, can be used together in a drying process. Commercial carrot extract contains prolactin-like active ingredients such as agnuside, aucbin, and castisin.

本発明の実施例においては、セイヨウニンジンボクの乾燥果実から50%エタノール水溶液で抽出し、水分およびエタノールを蒸発させた濃縮物に40%重量のマルトデキストリンを添加し噴霧乾燥させたものをセイヨウニンジンボクエキスとして用いた。   In an embodiment of the present invention, a carrot was obtained by adding 40% by weight maltodextrin to a concentrate obtained by extracting 50% ethanol solution from a dried carrot fruit and evaporating water and ethanol, followed by spray drying. Used as my extract.

本発明においては必要に応じて食品添加物、食品として使用される他の添加剤、例えば乳糖、麦芽糖、ブドウ糖、ショ糖、還元麦芽糖、還元乳糖、澱粉、セルロース、セルロース誘導体、デキストリンなどの賦形剤、吸着剤、着色料、香料等を使用してもよい。   In the present invention, food additives and other additives used as foods as necessary, such as lactose, maltose, glucose, sucrose, reduced maltose, reduced lactose, starch, cellulose, cellulose derivatives, dextrin and the like Agents, adsorbents, colorants, fragrances and the like may be used.

本発明の組成物を製造するには、例えば錠剤とする場合は、セイヨウニンジンボクの果実若しくはその抽出物、或いはその他の活性成分若しくはその誘導体及び必要に応じて添加剤を混合し、アルコール水溶液を加え、混合、乾燥、粉砕したものに滑沢剤を添加して打錠すればよい。本発明の組成物は錠剤に限らず、常法によりカプセル、顆粒、一般飲料、焼き菓子、パン等の任意の食品とすることができる。   In order to produce the composition of the present invention, for example, in the case of a tablet, a carrot fruit or an extract thereof, or other active ingredients or derivatives thereof and, if necessary, an additive are mixed, and an aqueous alcohol solution is prepared. In addition, a lubricant may be added to the mixture, dried and pulverized for tableting. The composition of the present invention is not limited to tablets, and can be made into any food such as capsules, granules, general beverages, baked goods, and breads by conventional methods.

本発明に包含される食品としては、乾燥食品、サプリメントなどの固形食品、また、清涼飲料やミネラルウォーター、嗜好飲料、アルコール飲料などの液状食品が挙げられる。固形食品としては、特に限定されるものではないが、練り製品、大豆加工品、調味料、ムース、ゼリー、冷菓、飴、チョコレート、ガム、クラッカー、ケーキ、パンなどが挙げられる。また、液状食品としては、特に限定されるものではないが、緑茶、ウーロン茶、紅茶、ハーブティーなどの茶類、濃縮果汁、濃縮還元ジュース、ストレートジュース、果実ミックスジュース、果肉入り果実ジュース、果汁入り飲料、果実・野菜ミックスジュース、野菜ジュース、炭酸飲料、清涼飲料、乳飲料、日本酒、ビール、ワイン、カクテル、焼酎、ウイスキーなどが挙げられる。本発明に含有される食品としてはまた、アミノ酸、タンパク質、ミネラルなどの各種栄養素を含有する栄養食品、栄養補助食品なども挙げられる。   Examples of foods included in the present invention include solid foods such as dried foods and supplements, and liquid foods such as soft drinks, mineral water, taste drinks, and alcoholic drinks. Examples of the solid food include, but are not limited to, kneaded products, processed soybean products, seasonings, mousses, jelly, frozen desserts, strawberries, chocolate, gum, crackers, cakes, breads and the like. The liquid food is not particularly limited, but teas such as green tea, oolong tea, black tea, herbal tea, concentrated fruit juice, concentrated reduced juice, straight juice, fruit mixed juice, fruit juice with fruit juice, fruit juice drink , Fruit / vegetable mixed juice, vegetable juice, carbonated drink, soft drink, milk drink, sake, beer, wine, cocktail, shochu, whiskey, etc. Examples of the food contained in the present invention also include nutritional foods and nutritional supplements containing various nutrients such as amino acids, proteins, and minerals.

また、本発明に包含される医薬品としては、溶液、懸濁物、粉末、固体成型物などのいずれでもよく、その剤型としては、錠剤、カプセル剤、粉末剤、顆粒剤、ドリンク剤、注射剤、貼付剤、坐剤、吸入剤などが挙げられる。   In addition, the pharmaceutical products included in the present invention may be any of solutions, suspensions, powders, solid moldings, and the dosage forms include tablets, capsules, powders, granules, drinks, injections. Agents, patches, suppositories, inhalants and the like.

本発明の組成物の製法は、一般的な食品または医薬品の製法を適用することができる。   As a method for producing the composition of the present invention, a general food or pharmaceutical production method can be applied.

本発明の所望の効果を得るための本発明の組成物の投与量は、セイヨウニンジンボクのエキスとして、好ましくは0.3〜10g/日、より好ましくは、0.5〜5g/日である。ただし、個体差(疾患の重篤度、性別、年齢など)があるため、本発明における投与量は、かかる範囲にのみ限定されるものではなく、本発明の所望の効果が得られるように、個別具体的に投与量を適宜設定すればよい。   The dose of the composition of the present invention for obtaining the desired effect of the present invention is preferably 0.3 to 10 g / day, more preferably 0.5 to 5 g / day, as a carrot extract. . However, since there are individual differences (disease severity, sex, age, etc.), the dosage in the present invention is not limited to such a range, so that the desired effect of the present invention can be obtained. The dose may be appropriately set individually and specifically.

本発明の組成物の投与方法としては、特に限定されないが、好ましくは、経口投与であり、前記の好適範囲で投与すればよい。   The administration method of the composition of the present invention is not particularly limited, but is preferably oral administration, and may be administered within the above-mentioned preferred range.

本発明の組成物は、糖尿病性マウスにおいて、血液中のグルコース濃度と尿タンパク質量の低下がもたらされることが見出されている。従って、本発明の組成物は、糖尿病の予防、改善および治療効果も併せ持つ。   It has been found that the composition of the present invention results in a decrease in blood glucose concentration and urine protein content in diabetic mice. Therefore, the composition of the present invention also has preventive, ameliorating and therapeutic effects for diabetes.

以下に本発明を糖尿病性脂肪肝モデルマウスを用いた試験例により説明するが、本発明の範囲がこれらによって限定されるものではない。   Hereinafter, the present invention will be described with reference to test examples using diabetic fatty liver model mice, but the scope of the present invention is not limited thereto.

試験例
糖尿病性脂肪肝の予防・改善・治療試験
(1) 試験飼料の調製
動物試験の試験群は試験飼料の投与によって、以下のように分類した。
(A)通常食(LF)群
(B)高脂肪・高ショ糖食(HFS)群
オリエンタル酵母工業株式会社により調製された高脂肪・高ショ糖食(F2HFHSD :脂肪含量30%(v/v)、ショ糖含量20%(v/v))にデキストリン(松谷化学工業 製:パインデックス)を0.66%(v/v)となるように添加して混合し調製した。
(C)高脂肪・高ショ糖食+セイヨウニンジンボク1.0%(HFS+VA1.0%)群
HFSにセイヨウニンジンボクエキスパウダー(商品名:アグニ乾燥エキス、アスク 薬品株式会社製、賦形剤:40%含有)を1.67%(v/v)となるように添加した もの。
Test example
Diabetes Fatty Liver Prevention / Improvement / Treatment Test (1) Preparation of Test Feed The test group of the animal test was classified as follows according to the administration of the test feed.
(A) Normal diet (LF) group
(B) High fat / high sucrose diet (HFS) group High fat / high sucrose diet prepared by Oriental Yeast Co., Ltd. (F2HFHSD: fat content 30% (v / v), sucrose content 20% (v / v)) was added and mixed with dextrin (manufactured by Matsutani Chemical Industry: Paindex) so as to be 0.66% (v / v).
(C) High fat and high sucrose diet + carrot box 1.0% (HFS + VA 1.0%) group
Carrot box extract powder (trade name: Agni dry extract, manufactured by Ask Pharmaceutical Co., Ltd., excipient: 40% contained) added to HFS to 1.67% (v / v).

(2)試験方法
4週齢の雄性自然発症II型糖尿病モデルマウス(KKAy-TaJcl)を日本クレア株式会社(東京)より購入し、飼育・繁殖用飼料(CRF-1、オリエンタル酵母工業)を用いて1週間の馴化を行った。その後、1群6匹の群わけを行い、各マウスに(1)に示した各試験飼料を1ヶ月間、自由に摂餌させた。その間、1週間に二回、一般状態の観察、体重及び摂餌量を測定した。1ヶ月間の摂餌の後、絶食後採血、屠殺し、血漿中のGOT/AST、GPT/ALT活性、肝臓中のトリグリセリド(中性脂肪)、総コレステロール濃度を測定し、糖尿病性脂肪肝の発症と改善を確認した。
肝臓サンプルを乳鉢内で凍結状態にて粉砕し、約150mgを秤量した。秤量したサンプルにメタノール(和光純薬 特級)を500μLを入れ、氷冷下にてホモジナイズし、クロロホルム(和光純薬 特級)を1,000μLを加え、冷温下で一晩放置した。
その後、4℃、15,000rpmにて5分間遠心分離を行い、上層800μLを採取し、200μLの0.9% 塩化ナトリウム水溶液と混合した。さらに4℃、15,000rpmにて5分間遠心分離を行い、上層をすべて除去した。得られた下層より50μLを窒素乾固し、200μLのイソプロパノール(和光純薬 特級)を加え、溶解させ、4℃、15,000rpmにて5分間遠心分離した上層を試験サンプルとした。
以下、トリグリセリド(TG)、および総コレステロール濃度(TC)の測定に用いた。
(2) Test method Four-week-old male spontaneous type II diabetes model mouse (KKA y -TaJcl) was purchased from CLEA Japan (Tokyo) and fed for breeding and breeding (CRF-1, Oriental Yeast Industry). And acclimated for 1 week. Thereafter, 6 groups were divided into groups, and each mouse was allowed to freely feed each test feed shown in (1) for 1 month. Meanwhile, twice a week, general condition observation, body weight and food intake were measured. After feeding for 1 month, blood was collected after fasting, sacrificed, plasma GOT / AST, GPT / ALT activity, liver triglyceride (neutral fat), total cholesterol levels were measured, and diabetic fatty liver Onset and improvement were confirmed.
The liver sample was pulverized in a frozen state in a mortar, and about 150 mg was weighed. To the weighed sample, 500 μL of methanol (Wako Pure Chemical) was added, homogenized under ice-cooling, and 1,000 μL of chloroform (Wako Pure Chemical) was added, and allowed to stand overnight at cold temperature.
Thereafter, centrifugation was performed at 15,000 rpm for 5 minutes at 4 ° C., and 800 μL of the upper layer was collected and mixed with 200 μL of a 0.9% sodium chloride aqueous solution. Further, centrifugation was performed at 4 ° C. and 15,000 rpm for 5 minutes to remove all the upper layer. 50 μL of the obtained lower layer was dried with nitrogen, 200 μL of isopropanol (Wako Pure Chemical) was added, dissolved, and centrifuged at 4 ° C. and 15,000 rpm for 5 minutes, and the upper layer was used as a test sample.
Hereinafter, it was used for measurement of triglyceride (TG) and total cholesterol concentration (TC).

TG分析
試験サンプル2μLにトリグリセリドEテストワコー(和光純薬)を300μL加え、37℃で120分間放置した後、600nmの吸光度にて吸光度を測定し、検量線より肝臓TG値を測定した。
TG analysis 300 μL of triglyceride E test Wako (Wako Pure Chemical Industries, Ltd.) was added to 2 μL of the test sample, and allowed to stand at 37 ° C. for 120 minutes. Then, the absorbance was measured at an absorbance of 600 nm, and the liver TG value was measured from a calibration curve.

TC分析
試験サンプル2μLにコレステロールEテストワコー(和光純薬)を300μL加え、37℃で20分間放置した後、600nmの吸光度にて吸光度を測定し、検量線より肝臓TC値を測定した。
TC analysis 300 μL of Cholesterol E Test Wako (Wako Pure Chemical Industries) was added to 2 μL of the test sample, and left at 37 ° C. for 20 minutes. Then, the absorbance was measured at an absorbance of 600 nm, and the liver TC value was measured from a calibration curve.

(3)試験結果
セイヨウニンジンボクエキスは糖尿病性脂肪肝ラットの食欲や、体重には影響しなかったが、図1、図2に示すとおり、肝機能の指標である血漿GOT、GPTを顕著に改善した。また図3、図4に示すとおり肝臓中の中性脂肪並びに総コレステロールを顕著に抑制した。以上の結果からセイヨウニンジンボクエキスは糖尿病性脂肪肝の予防・改善・治療に効果があることが明らかとなった。また副作用を予想させるような症状や生化学データの異常は認められず、極めて安全な剤であることが確認された。
(3) Test results The carrot extract did not affect the appetite and body weight of diabetic fatty liver rats, but as shown in FIGS. 1 and 2, plasma GOT and GPT, which are indicators of liver function, were notable. Improved. Further, as shown in FIGS. 3 and 4, neutral fat and total cholesterol in the liver were remarkably suppressed. From the above results, it was revealed that carrot extract is effective in preventing, improving and treating diabetic fatty liver. In addition, no symptoms or biochemical data abnormalities that would predict side effects were observed, confirming that the drug was extremely safe.

以下に本発明で用いたセイヨウニンジンボクエキスを配合した処方例を示す。   The formulation example which mix | blended the carrot extract used by this invention below is shown.

処方例1
[カプセル剤]
組成
セイヨウニンジンボクエキス(セイヨウニンジンボク抽出物50%含有) … 50mg
トコトリエノール … 30mg
ミツロウ … 10mg
ぶどう種子オイル …110mg

上記成分を混合し、ゼラチン及びグリセリンを混合したカプセル基剤中に充填し、軟カ
プセルを得た。
Formulation Example 1
[Capsule]
Composition Carrot box extract (contains 50% carrot extract) ... 50mg
Tocotrienol 30mg
Beeswax 10mg
Grape seed oil… 110mg

The above ingredients were mixed and filled into a capsule base mixed with gelatin and glycerin to obtain soft capsules.

処方例2
[錠剤]
組 成
セイヨウニンジンボクエキス(セイヨウニンジンボク抽出物50%含有) … 25mg
マリアアザミ(シリマリン65%含有) … 20mg
コラーゲン加水分解物 … 50mg
セルロース … 40mg
デンプン … 20mg
ショ糖脂肪酸エステル … 2mg

上記成分を混合、打錠し、錠剤を得た。
Formulation Example 2
[tablet]
Composition carrot box extract (containing 50% carrot extract) ... 25mg
Maria Thistle (containing 65% silymarin) ... 20mg
Collagen hydrolyzate ... 50mg
Cellulose… 40mg
Starch… 20mg
Sucrose fatty acid ester 2mg

The above components were mixed and tableted to obtain tablets.

処方例3
〔ジュース〕
(組 成) (配合;質量%)
果糖ブトウ糖液糖 5.00
クエン酸 10.4
L−アスコルビン酸 0.20
香料 0.02
色素 0.10
ゼラチン分解物(平均分子量300) 1.00
セイヨウニンジンボクエキス(セイヨウニンジンボク抽出物50%含有) 1.00
水 82.28
Formulation Example 3
〔juice〕
(Composition) (Composition: Mass%)
Fructose butter sugar liquid sugar 5.00
Citric acid 10.4
L-ascorbic acid 0.20
Perfume 0.02
Dye 0.10
Gelatin degradation product (average molecular weight 300) 1.00
Carrot box extract (containing 50% carrot box extract) 1.00
Water 82.28

Claims (4)

セイヨウニンジンボクエキスを含有する糖尿病性脂肪肝の予防、改善または治療用組成物。   A composition for prevention, amelioration or treatment of diabetic fatty liver, comprising carrot extract. セイヨウニンジンボクエキスがセイヨウニンジンボク果実エキスである請求項1記載の組成物。   The composition according to claim 1, wherein the carrot extract is a carrot fruit extract. 請求項1又は請求項2記載の組成物を含有する医薬。   A medicament comprising the composition according to claim 1 or 2. 請求項1又は請求項2記載の組成物を含有する健康食品。
A health food comprising the composition according to claim 1 or 2.
JP2011064390A 2011-03-23 2011-03-23 Composition for preventing, ameliorating or treating diabetic fatty liver Pending JP2012201593A (en)

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JP2003012533A (en) * 2001-05-09 2003-01-15 Novartis Nutrition Ag Vitex agnus castus extract
WO2009054504A1 (en) * 2007-10-24 2009-04-30 Suntory Holdings Limited Ligand agent for peroxisome proliferator-activated receptor (ppar)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103655929A (en) * 2013-12-06 2014-03-26 江苏德和生物科技有限公司 Pharmaceutical composition with liver-protecting effect and preparation method thereof
CN103655929B (en) * 2013-12-06 2017-01-18 江苏德和生物科技有限公司 Pharmaceutical composition with liver-protecting effect and preparation method thereof

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