JPWO2013018706A1 - Composition for modulating URAT1 activity - Google Patents
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
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Abstract
本発明は、日常的に摂取しても安全な、タウリンを有効成分として含有することを特徴とするＵＲＡＴ１活性を調節するための組成物を提供する。 The present invention provides a composition for regulating URAT1 activity, comprising taurine as an active ingredient, which is safe even if taken daily.
Description
本発明は、ＵＲＡＴ１活性を調節するための組成物に関するものである。 The present invention relates to a composition for modulating URAT1 activity.
腎臓は生体内因子や薬物、栄養素、機能性因子、化合物等、様々な物質の排泄に関与しており、その排泄量は腎臓に発現するトランスポーターにより調節されている。腎臓に発現しているＵＲＡＴ１（urate transporter 1）は尿酸、ニコチン酸、コハク酸等、生体内で重要な役割を果たしている因子、さらにはサリチル酸やインドメタシンといった薬物の輸送に関与していることが知られており、その活性を調節することにより生体機能を良好に調節できる可能性が示唆されている（非特許文献１参照）。例えば、ＵＲＡＴ１活性調節剤として知られているベンズブロマロンは、高尿酸血症改善医薬品として使用されている。また、ＵＲＡＴ１活性調節剤が現在も探索されている（非特許文献２参照）が、日常的に摂取しても安全なＵＲＡＴ１活性調節剤は、これまでに知られていない。 The kidney is involved in the excretion of various substances such as in vivo factors, drugs, nutrients, functional factors, and compounds, and the excretion is regulated by transporters expressed in the kidney. URAT1 (urate transporter 1) expressed in the kidney is known to be involved in the transport of factors such as uric acid, nicotinic acid, and succinic acid that play important roles in the body, as well as drugs such as salicylic acid and indomethacin. It has been suggested that the biological function can be adjusted well by adjusting the activity (see Non-Patent Document 1). For example, benzbromarone known as a URAT1 activity regulator is used as a drug for improving hyperuricemia. Moreover, although URAT1 activity regulators are still being searched for (see Non-Patent Document 2), no URAT1 activity regulator that is safe even if taken daily has not been known so far.
タウリン（アミノエチルスルホン酸）は含硫アミノ酸の一種で、世界中で医薬品、医薬部外品あるいはサプリメント等として日常的に摂取されていることからも、安全性の高い成分であると言える。タウリンには様々な生理作用が知られているが（非特許文献３参照）、ＵＲＡＴ１活性を調節することは知られていない。 Taurine (aminoethylsulfonic acid) is a kind of sulfur-containing amino acid, and since it is taken daily as a pharmaceutical, quasi-drug or supplement throughout the world, it can be said to be a highly safe component. Although various physiological actions are known for taurine (see Non-Patent Document 3), it is not known to regulate URAT1 activity.
本発明の目的は、日常的に摂取しても安全なＵＲＡＴ１活性を調節するための組成物を提供することである。 An object of the present invention is to provide a composition for regulating URAT1 activity that is safe even when taken on a daily basis.
本発明者らは、前記課題を解決すべく鋭意検討を重ねた結果、タウリンがＵＲＡＴ１活性を調節することを見出し、本発明を完成した。 As a result of intensive studies to solve the above problems, the present inventors have found that taurine regulates URAT1 activity, and have completed the present invention.
かかる本発明の態様は、タウリンを有効成分として含有することを特徴とするＵＲＡＴ１活性を調節するための組成物である。 Such an aspect of the present invention is a composition for regulating URAT1 activity, which comprises taurine as an active ingredient.
本発明の他の態様は、経口投与剤である前記組成物である。 Another embodiment of the present invention is the above composition that is an orally administered agent.
本発明により、日常的に摂取しても安全な、ＵＲＡＴ１活性を調節するための組成物を提供することが可能となった。 According to the present invention, it is possible to provide a composition for regulating URAT1 activity, which is safe even if taken daily.
本発明は、タウリンを有効成分として含有することを特徴とするＵＲＡＴ１活性を調節するための組成物を提供する。 The present invention provides a composition for regulating URAT1 activity, which comprises taurine as an active ingredient.
本発明における「ＵＲＡＴ１」は、腎臓に発現するトランスポーターであり、ＲＳＴ、ＯＡＴ４Ｌ、ＳＬＣ２２Ａ１２等の別名がつけられているトランスポーターをも包含する。ヒト由来のＵＲＡＴ１の典型的な塩基配列及びアミノ酸配列は、ＧｅｎＢａｎｋ（ＡＢ０７１８６３）に開示されている。 “URAT1” in the present invention is a transporter expressed in the kidney, and includes transporters to which aliases such as RST, OAT4L, SLC22A12 and the like are attached. A typical base sequence and amino acid sequence of URAT1 derived from human is disclosed in GenBank (AB071863).
本発明において「ＵＲＡＴ１活性を調節する」とは、典型的には、ＵＲＡＴ１遺伝子の発現を低下させることにより、ＵＲＡＴ１活性が発揮されるのを抑制することを意味する。 In the present invention, “modulating URAT1 activity” typically means suppressing the exertion of URAT1 activity by reducing the expression of the URAT1 gene.
本発明の組成物は、医薬組成物（医薬品、医薬部外品など）、飲食品、あるいは研究目的（例えば、インビボの実験目的など）に用いられる試薬の形態であり得る。 The composition of the present invention may be in the form of a pharmaceutical composition (pharmaceuticals, quasi drugs, etc.), food and drink, or a reagent used for research purposes (eg, in vivo experimental purposes).
本発明の組成物を医薬組成物として用いる場合、有効成分としてタウリンを含有するものであればその剤形は特に限定されない。本発明の医薬組成物は、公知の製剤学的方法により種々の剤形で製剤化することができる。例えば、錠剤、顆粒剤、散剤、カプセル剤、丸剤、細粒剤、微粒剤、チュアブル剤、トローチ剤、フィルムコーティング剤、ペレット剤、舌下剤、咀嚼剤、バッカル剤、液剤、シロップ剤、懸濁剤、エリキシル剤、乳剤、ペースト剤、エアゾール剤、注射剤、坐剤などとして、経口的または非経口的に使用することができる。 When the composition of the present invention is used as a pharmaceutical composition, its dosage form is not particularly limited as long as it contains taurine as an active ingredient. The pharmaceutical composition of the present invention can be formulated into various dosage forms by known pharmaceutical methods. For example, tablet, granule, powder, capsule, pill, fine granule, fine granule, chewable, troche, film coating, pellet, sublingual, chewing agent, buccal, liquid, syrup, suspension It can be used orally or parenterally as a suspension, elixir, emulsion, paste, aerosol, injection, suppository and the like.
本発明の医薬組成物は、好ましくは、経口投与剤である。経口投与剤としては、錠剤、顆粒剤、散剤、カプセル剤、丸剤、細粒剤、微粒剤、チュアブル剤、トローチ剤などの内服固形製剤やドリンク剤などの内服液剤が挙げられる。 The pharmaceutical composition of the present invention is preferably an oral administration agent. Examples of the oral administration agent include solid preparations such as tablets, granules, powders, capsules, pills, fine granules, fine granules, chewable preparations, and lozenges, and oral liquid preparations such as drinks.
本発明の医薬組成物を経口投与剤として提供するに際しては、本発明の効果を損なわない質的及び量的範囲で、他の有効成分や公知の添加剤を配合することができる。このようなものとしては、生薬、天然物、賦形剤、ｐＨ調整剤、清涼化剤、懸濁化剤、粘稠剤、溶解補助剤、崩壊剤、結合剤、滑沢剤、抗酸化剤、コーティング剤、着色剤、矯味剤、界面活性剤、可塑剤、香料が挙げられる。 In providing the pharmaceutical composition of the present invention as an orally administered agent, other active ingredients and known additives can be blended within a qualitative and quantitative range that does not impair the effects of the present invention. Such as herbal medicines, natural products, excipients, pH adjusting agents, cooling agents, suspending agents, thickeners, solubilizers, disintegrating agents, binders, lubricants, antioxidants , Coating agents, colorants, flavoring agents, surfactants, plasticizers, and fragrances.
本発明の組成物を医薬組成物として用いる場合には、ＵＲＡＴ１活性の調節に有効な１種もしくは２種以上の他の成分を配合することができる。また、ＵＲＡＴ１活性の調節に有効な他の医薬組成物と併用してもよい。 When the composition of the present invention is used as a pharmaceutical composition, one or more other components effective for regulating URAT1 activity can be blended. Moreover, you may use together with the other pharmaceutical composition effective in the regulation of URAT1 activity.
本発明の組成物を飲食品として用いる場合、当該飲食品は、例えば、健康食品、機能性食品、特定保健用食品、栄養補助食品、病者用食品、あるいは食品添加物、であり得る。飲食品の具体例としては、ドリンク類、スープ類、乳飲料、清涼飲料水、茶飲料、アルコール飲料、ゼリー状飲料、機能性飲料等の液状食品；食用油、ドレッシング、マヨネーズ、マーガリンなどの油分を含む製品；飯類、麺類、パン類等の炭水化物含有食品；ハム、ソーセージ等の畜産加工食品；かまぼこ、干物、塩辛等の水産加工食品；漬物等の野菜加工食品；ゼリー、ヨーグルト等の半固形状食品；みそ、発酵飲料等の発酵食品；洋菓子類、和菓子類、キャンディー類、ガム類、グミ、冷菓、氷菓等の各種菓子類；カレー、あんかけ、中華スープ等のレトルト製品；インスタントスープ，インスタントみそ汁等のインスタント食品や電子レンジ対応食品等が挙げられる。さらには、粉末、穎粒、錠剤、カプセル剤、液状、ペースト状またはゼリー状に調製された健康飲食品も挙げられる。 When the composition of the present invention is used as a food or drink, the food or drink can be, for example, a health food, a functional food, a food for specified health use, a dietary supplement, a food for a sick person, or a food additive. Specific examples of food and drink include liquid foods such as drinks, soups, milk beverages, soft drinks, tea beverages, alcoholic beverages, jelly-like beverages, functional beverages; oils such as edible oils, dressings, mayonnaise, margarines Products containing carbohydrates; Foods containing carbohydrates such as rice, noodles, and bread; Livestock processed foods such as ham and sausage; Fish processed foods such as kamaboko, dried fish, and salty; Vegetable processed foods such as pickles; Semis such as jelly and yogurt Solid foods; Fermented foods such as miso and fermented beverages; Various confectionery such as Western confectionery, Japanese confectionery, candy, gums, gummi, frozen confectionery, ice confectionery; Retort products such as curry, sauce, Chinese soup; Instant soup Examples include instant foods such as instant miso soup and foods for microwave ovens. Furthermore, health foods and drinks prepared in the form of powder, granules, tablets, capsules, liquid, paste or jelly are also included.
本発明における飲食品の製造は、当該技術分野に公知の製造技術により実施することができる。当該飲食品においては、ＵＲＡＴ１活性の調節に有効な１種もしくは２種以上の成分を配合してもよい。また、ＵＲＡＴ１活性の調節以外の機能を発揮する他の成分あるいは他の機能性食品と組み合わせることによって、多機能性の飲食品としてもよい。 Manufacture of the food-drinks in this invention can be implemented with a manufacturing technique well-known in the said technical field. In the said food-drinks, you may mix | blend the 1 type, or 2 or more types of component effective in the regulation of URAT1 activity. Moreover, it is good also as multifunctional food-drinks by combining with the other component which exhibits functions other than control of URAT1 activity, or another functional food.
本発明の組成物の有効成分としてのタウリンの投与量または摂取量は、通常、成人ではタウリンとして１００〜３０００ｍｇを１日１〜３回、好ましくは１０００〜３０００ｍｇを１日２〜３回、さらに好ましくは1回１０００〜２０００ｍｇを１日２〜３回であり、これは、投与ルート、年齢、性別、症状の重症度などにより適宜増減することも可能である。本発明は、このように、本発明の組成物を対象に投与もしくは摂取させることを特徴とする、対象におけるＵＲＡＴ１活性を調節する方法をも提供するものである。 The dose or intake of taurine as an active ingredient of the composition of the present invention is usually 100 to 3000 mg as taurine 1-3 times a day for adults, preferably 1000 to 3000 mg 2 to 3 times a day, Preferably, it is 1000 to 2000 mg at a time, 2 to 3 times a day, and this may be appropriately increased or decreased depending on the route of administration, age, sex, severity of symptoms, and the like. The present invention thus also provides a method of modulating URAT1 activity in a subject, characterized by administering or ingesting the composition of the present invention to the subject.
本発明の組成物の製品（医薬品、医薬部外品、飲食品、試薬など）またはその説明書は、ＵＲＡＴ１活性の調節のために用いられる旨の表示を付したものであり得る。ここで「製品または説明書に表示を付した」とは、製品の本体、容器、包装などに表示を付したこと、あるいは製品の情報を開示する説明書、添付文書、宣伝物、その他の印刷物などに表示を付したことを意味する。ＵＲＡＴ１活性の調節のために用いられる旨の表示においては、本発明の組成物を投与もしくは摂取することによりＵＲＡＴ１活性が調節される機序についての情報を含むことができる。 The product of the composition of the present invention (pharmaceutical, quasi-drug, food and drink, reagent, etc.) or instructions thereof may be labeled with an indication that it is used for the regulation of URAT1 activity. Here, “labeled product or instructions” means that the product body, container, packaging, etc. are marked, or instructions, package inserts, promotional materials, or other printed materials that disclose product information. It means that the display is attached to. The indication that it is used to modulate URAT1 activity can include information about the mechanism by which URAT1 activity is modulated by administering or ingesting the composition of the present invention.
以下に試験例により、本発明をさらに具体的に説明する。 Hereinafter, the present invention will be described more specifically with reference to test examples.
[試験例１]
５週齢の雌性Ｗｉｓｔａｒ Ｈａｎｎｏｖｅｒ／Ｒｃｃラット（日本エスエルシー株式会社）を、各群の平均体重がほぼ同等となるように１群４匹で２群に分けた。[Test Example 1]
Five-week-old female Wistar Hanover / Rcc rats (Japan SLC Co., Ltd.) were divided into two groups with four animals per group so that the average body weight of each group was approximately the same.
対照群には水を、タウリン投与群にはタウリンを１００ｍｇ／ｋｇの用量で経口投与した。その２４時間後にペントバルビタール麻酔下で開腹し、腎臓を摘出した。ＲＮｅａｓｙ Ｍｉｎｉ Ｋｉｔ（Ｑｉａｇｅｎ社製）を用いてＴｏｔａｌ ＲＮＡを抽出した。Ｈｉｇｈ Ｃａｐａｃｉｔｙ ＲＮＡ−ｔｏ−ｃＤＮＡ Ｍａｓｔｅｒ Ｍｉｘ（Ａｐｐｌｉｅｄ Ｂｉｏｓｙｓｔｅｍｓ社製）を用いて逆転写し、ＵＲＡＴ１プライマー（Ａｐｐｌｉｅｄ Ｂｉｏｓｙｓｔｅｍｓ社製）を用いて、Ｒｅａｌ Ｔｉｍｅ ＰＣＲ法にて腎臓中ＵＲＡＴ１ ｍＲＮＡ量を測定した。 Water was orally administered to the control group and taurine was orally administered to the taurine administration group at a dose of 100 mg / kg. 24 hours later, the abdomen was opened under pentobarbital anesthesia, and the kidney was removed. Total RNA was extracted using RNeasy Mini Kit (Qiagen). Reverse transcription was performed using High Capacity RNA-to-cDNA Master Mix (manufactured by Applied Biosystems), and the amount of URAT1 mRNA in the kidney was measured by Real Time PCR method using URAT1 primer (manufactured by Applied Biosystems).
対照群のＵＲＡＴ１ ｍＲＮＡ量の平均値を１００としたときの、対照群およびタウリン投与群のＵＲＡＴ１ ｍＲＮＡ量の平均値および標準誤差を表１に示した。その結果、対照群と比較してタウリン投与群でＵＲＡＴ１ ｍＲＮＡ量が有意に低下した（ｐ＜０．０５）。 Table 1 shows the average value and standard error of the URAT1 mRNA amount of the control group and the taurine administration group when the average value of the URAT1 mRNA amount of the control group is 100. As a result, the amount of URAT1 mRNA was significantly decreased in the taurine administration group compared with the control group (p <0.05).
本発明は、医薬品、医薬部外品、あるいは特定保健用食品（健康増進法第26条第1項の許可又は第29条第1項の承認を受け、食生活において特定の保健の目的で摂取する者に対し、その摂取により当該保健の目的が期待できる旨の表示をする食品）等の特定の機能の表示が許可されている機能性食品等として提供することが可能である。 The present invention is intended to be used for specific health purposes in eating habits, with the approval of Article 26, Paragraph 1 of Article 26, Paragraph 1 of the Health Promotion Act. It is possible to provide functional foods and the like that are permitted to display specific functions such as foods that indicate that the purpose of the health can be expected by ingestion.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2011034006A1 (en) * | 2009-09-17 | 2011-03-24 | 大正製薬株式会社 | Composition for lowering blood uric acid level |
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2012
- 2012-07-27 WO PCT/JP2012/069167 patent/WO2013018706A1/en active Application Filing
- 2012-07-27 JP JP2013526888A patent/JPWO2013018706A1/en active Pending
- 2012-08-01 TW TW101127776A patent/TW201320993A/en unknown
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011034006A1 (en) * | 2009-09-17 | 2011-03-24 | 大正製薬株式会社 | Composition for lowering blood uric acid level |
Non-Patent Citations (3)
| Title |
|---|
| JPN6015032352; Ｊ Ｍｅｄ Ｃｈｅｍ． ＶＯＬ．５４ Ｎｏ．８, 20110330, ｐ．２７０１-２７１３, Ａｍｅｒｉｃａｎ Ｃｈｅｍｉｃａｌ Ｓｏｃｉｅｔｙ * |
| JPN6015032356; 日本薬理学雑誌 ＶＯＬ．１３６ ＮＯ．６, 2010, ｐ．３２５-３２９ * |
| JPN6015032357; 東京慈恵会医科大学雑誌 ＶＯＬ．１２１ ＮＯ．２, 2006, ｐ．４９-５４ * |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2013018706A1 (en) | 2013-02-07 |
| TW201320993A (en) | 2013-06-01 |
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