TW201320993A - Composition for regulating urat1 activity - Google Patents
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- TW201320993A TW201320993A TW101127776A TW101127776A TW201320993A TW 201320993 A TW201320993 A TW 201320993A TW 101127776 A TW101127776 A TW 101127776A TW 101127776 A TW101127776 A TW 101127776A TW 201320993 A TW201320993 A TW 201320993A
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- 235000021067 refined food Nutrition 0.000 description 2
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- 244000269722 Thea sinensis Species 0.000 description 1
- JZRWCGZRTZMZEH-UHFFFAOYSA-N Thiamine Natural products CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N JZRWCGZRTZMZEH-UHFFFAOYSA-N 0.000 description 1
- LEHOTFFKMJEONL-UHFFFAOYSA-N Uric Acid Chemical compound N1C(=O)NC(=O)C2=C1NC(=O)N2 LEHOTFFKMJEONL-UHFFFAOYSA-N 0.000 description 1
- TVWHNULVHGKJHS-UHFFFAOYSA-N Uric acid Natural products N1C(=O)NC(=O)C2NC(=O)NC21 TVWHNULVHGKJHS-UHFFFAOYSA-N 0.000 description 1
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- FJKROLUGYXJWQN-UHFFFAOYSA-N papa-hydroxy-benzoic acid Natural products OC(=O)C1=CC=C(O)C=C1 FJKROLUGYXJWQN-UHFFFAOYSA-N 0.000 description 1
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- KYMBYSLLVAOCFI-UHFFFAOYSA-N thiamine Chemical compound CC1=C(CCO)SCN1CC1=CN=C(C)N=C1N KYMBYSLLVAOCFI-UHFFFAOYSA-N 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/17—Amino acids, peptides or proteins
- A23L33/175—Amino acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/06—Antigout agents, e.g. antihyperuricemic or uricosuric agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Abstract
Description
本發明係關於使用於調節URAT1活性的組成物者。 The present invention relates to a composition for use in modulating the activity of URAT1.
腎臟係參與生物體內因子或藥物、營養素、機能性因子、化合物等各種物質之排泄，該排泄量係藉由於腎臟表現之傳送子所調節。已知於腎臟表現之URAT1(urate transporter 1，尿酸傳送子1)係參與尿酸、菸鹼酸、琥珀酸等之於生物體內扮演重要角色之因子，進而水楊酸或吲哚美辛(Indometacin)之藥物之輸送，藉由調節該活性，顯示可良好地調節身體機能之可能性(參考非專利文獻1)。例如，已知作為URAT1活性調節劑之benzbromarone係作為高尿酸血症改善醫藥品使用。另外，現在亦探索URAT1活性調節劑(參考非專利文獻2)，但至今仍未知即使日常上攝取亦安全之URAT1活性調節劑。 The kidney system is involved in the excretion of various factors such as factors or drugs, nutrients, functional factors, and compounds in the body, and the excretion is regulated by the transmitter of the kidney. URAT1 (urate transporter 1), which is known to be expressed in the kidney, is involved in factors such as uric acid, niacin, succinic acid, etc., which play an important role in the organism, and then salicylic acid or indoetacin. The delivery of the drug, by adjusting the activity, shows the possibility of well regulating the body function (refer to Non-Patent Document 1). For example, the benzbromarone which is a modulator of URAT1 activity is known to be used as a medicine for improving hyperuricemia. In addition, the URAT1 activity modulator has also been explored (refer to Non-Patent Document 2), but it has not been known until now that the URAT1 activity modulator is safe to be taken on a daily basis.
牛磺酸(胺基乙基磺酸)係一種含硫胺基酸，就在全世界作為醫藥品、醫藥部外用品或營養補給品等日常攝取一事，可說是安全性高之成份。已知牛磺酸的各種生理作用(參考非專利文獻3)，但未知調節URAT1活性。 Taurine (Amino Ethylsulfonic Acid) is a thiamine-containing acid that is safely used as a daily intake of pharmaceuticals, medical supplies, or nutritional supplements. Various physiological actions of taurine are known (refer to Non-Patent Document 3), but it is not known to modulate URAT1 activity.
非專利文獻1：Nature 2002 417 447-452 Non-Patent Document 1: Nature 2002 417 447-452
非專利文獻2：J Med Chem. 2011 54 (8) 2701-13 Non-Patent Document 2: J Med Chem. 2011 54 (8) 2701-13
非專利文獻3：FEMS Microbiol Lett. 2003 226 (2) 195-202 Non-Patent Document 3: FEMS Microbiol Lett. 2003 226 (2) 195-202
本發明之目的係提供即使日常上攝取亦安全之使用於調節URAT1活性的組成物。 The object of the present invention is to provide a composition which is safe for use in regulating URAT1 activity even when taken daily.
本發明者等，為解決前述課題，重複努力檢討的結果，發現牛磺酸調節URAT1活性，完成本發明。 In order to solve the above problems, the inventors of the present invention have repeated efforts to review and found that taurine regulates URAT1 activity, and completed the present invention.
關於本發明的型態，含有牛磺酸作為有效成份為特徵之使用於調節URAT1活性的組成物。 Regarding the form of the present invention, a composition containing taurine as an active ingredient for regulating the activity of URAT1 is used.
本發明之其他型態係經口投予劑之前述組成物。 Other forms of the invention are the aforementioned compositions of the oral administration.
藉由本發明，將可提供即使日常上攝取亦安全之使用於調節URAT1活性的組成物。 According to the present invention, it is possible to provide a composition which is safe for use in regulating the activity of URAT1 even if it is taken up on a daily basis.
本發明係提供含有牛磺酸作為有效成份為特徵之使用於調節URAT1活性的組成物。 The present invention provides a composition for regulating the activity of URAT1 which is characterized by containing taurine as an active ingredient.
本發明中「URAT1」係於腎臟表現之傳送子，亦包含賦予RST、OAT4L、SLC22A12等別名之傳送子。來自人類的URAT1之典型的鹽基序列及胺基酸序列係揭示於GenBank(AB071863)。 In the present invention, "URAT1" is a transmitter for the expression of the kidney, and also includes a transmitter that gives an alias such as RST, OAT4L, and SLC22A12. A typical base sequence and amino acid sequence of URAT1 from humans is disclosed in GenBank (AB071863).
本發明中所謂的「調節URAT1活性」係指典型上藉由降低URAT1基因表現，抑制所發揮的URAT1活性。 The "modulating URAT1 activity" in the present invention means that the URAT1 activity exerted by inhibition is typically suppressed by reducing the expression of the URAT1 gene.
本發明之組成物可為醫藥組成物(醫藥品、醫藥部外用品等)、飲食品、或研究目的(例如在體內之實驗目的等)所使用之試劑型態。 The composition of the present invention may be a reagent form used for a pharmaceutical composition (pharmaceutical, medical external product, etc.), a food or drink, or a research purpose (for example, for experimental purposes in vivo).
使用本發明之組成物作為醫藥組成物時，只要含有牛磺酸作為有效成份者，其劑型不受特別限定。本發明之醫藥組成物係可藉由已知之製劑學方法，以各種劑型製劑化。例如作為錠劑、顆粒劑、散劑、膠囊劑、丸劑、細粒劑、微粒劑、可嚼劑、口含劑、膜衣劑、丸劑、舌下劑、咀嚼劑、口腔劑、液劑、糖漿劑、懸浮劑、酊劑、乳劑、糊狀劑、氣溶膠劑、注射劑、坐劑等，可經口或非經口地使用。 When the composition of the present invention is used as a pharmaceutical composition, the 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 in various dosage forms by known formulation methods. For example, as a tablet, granule, powder, capsule, pill, fine granule, microparticle, chewable, buccal, film coating, pill, sublingual, chewing, oral, liquid, syrup The agent, the suspension, the expectorant, the emulsion, the paste, the aerosol, the injection, the sitting agent, etc. can be used orally or parenterally.
本發明之醫藥組成物係以經口投予劑為宜。作為經口投予劑，可列舉錠劑、顆粒劑、散劑、膠囊劑、丸劑、細粒劑、微粒劑、口嚼劑、口含劑等之內服固形製劑或口服液劑等之內服液劑。 The pharmaceutical composition of the present invention is preferably an oral administration agent. Examples of the oral administration agent include internal liquid preparations such as tablets, granules, powders, capsules, pills, fine granules, microgranules, chewable agents, and buccal agents, and the like. .
提供本發明之醫藥組成物作為經口投予劑時，於不損及本發明功效之質及量的範圍，可摻混其他有效成份或已知添加劑。作為如此物，可列舉生藥、天然物、賦形劑、 pH調整劑、清涼化劑、懸浮化劑、黏稠劑、助溶劑、崩壞劑、結合劑、滑澤劑、抗氧化劑、被覆劑、著色劑、矯味劑、界面活性劑、可塑劑、香料。 When the pharmaceutical composition of the present invention is provided as an oral administration agent, other active ingredients or known additives may be blended in a range which does not impair the quality and quantity of the efficacy of the present invention. As such, raw medicines, natural substances, excipients, and the like can be cited. A pH adjuster, a cooling agent, a suspending agent, a thickener, a co-solvent, a breaker, a binder, a slip agent, an antioxidant, a coating agent, a coloring agent, a flavoring agent, a surfactant, a plasticizer, and a fragrance.
使用本發明之組成物作為醫藥組成物時，可摻混適用於調節URAT1活性的1種或2種以上的成份。另外，亦可併用有效的其他醫藥組成物於調節URAT1活性。 When the composition of the present invention is used as a pharmaceutical composition, one or two or more components suitable for adjusting the activity of URAT1 can be blended. In addition, effective other pharmaceutical compositions may be used in combination to modulate URAT1 activity.
使用本發明之組成物作為飲食品時，該飲食品例如可為健康食品、機能性食品、特定保健用食品、營養輔助食品、病患用食品或食品添加物。作為飲食品之具體例，可列舉飲料類、湯類、乳飲料、清涼飲料水、茶飲料、酒精飲料、果凍狀飲料、機能性飲料等之液體食品；食用油、沙拉醬、美乃滋、瑪淇淋等之含油份製品；飯類、麵類、麵包類等之含碳水化合物食品；火腿、香腸等之畜產品加工食品；魚板、干物、鹽辛等之水產加工食品；醃漬物等之蔬菜加工食品；果凍、優酪乳等之半固體食品；味噌、發酵飲料等之發酵食品；西式點心類、和式點心類、糖果類、口香糖類、軟糖類、冷點、冰菓等之各種點心類；咖哩、勾芡、中式湯等之殺菌袋製品；速食湯、速食味噌湯等之速食食品或微波爐食品等。進而，亦可列舉粉末、顆粒、錠劑、膠囊劑、調製成液狀、糊狀或果凍狀之健康飲食品。 When the composition of the present invention is used as a food or drink, the food or drink may be, for example, a health food, a functional food, a specific health food, a nutritional supplement, a patient food, or a food additive. Specific examples of foods and drinks include liquid foods such as beverages, soups, milk drinks, refreshing drink waters, tea drinks, alcoholic drinks, jelly-like drinks, and functional drinks; edible oils, salad dressings, and mayonnaise Oil-containing products such as cream; foods containing carbohydrates such as rice, noodles, bread, etc.; processed foods for livestock products such as ham and sausage; processed fish products such as fish, dried, salt, etc.; pickled products, etc. Vegetable processed foods; semi-solid foods such as jelly and yogurt; fermented foods such as miso and fermented beverages; western-style dim sum, dim sum, confectionery, chewing gum, soft candy, cold spot, ice fruit, etc. Dim Sum; sterilized bag products such as curry, thick chop, Chinese soup, instant food such as instant soup, instant miso soup, or microwave food. Further, examples thereof include powders, granules, troches, capsules, and healthy foods and drinks prepared in a liquid form, a paste form, or a jelly form.
本發明中飲食品之製造係可藉由該技術領域已知之製造技術而實施。該飲食品中，亦可摻混適用於調節URAT1活性的1種或2種以上的成份。另外，藉由組合 發揮調節URAT1活性以外的機能之其他成份或其他機能性食品，亦可作為多機能性飲食品。 The manufacture of foods and beverages of the present invention can be carried out by manufacturing techniques known in the art. In the food or drink, one or more components suitable for modulating the activity of URAT1 may be blended. In addition, by combination Other ingredients or other functional foods that regulate functions other than URAT1 activity can also be used as multi-functional foods and drinks.
作為本發明組成物之有效成份之牛磺酸之投予量或攝取量係通常成人為100~3000mg之牛磺酸，1日1~3次，以1000~3000mg，1日2~3次為宜，以1次1000~2000mg，1日2~3次尤佳，此亦可依投予途徑、年齡、性別、症狀之重症程度等而適當增減。本發明係如此地將本發明之組成物，投予於對象或使攝取為特徵，亦提供依對象調節URAT1活性之方法者。 The dosage or intake of taurine, which is an active ingredient of the composition of the present invention, is usually 100 to 3000 mg of taurine in adults, 1 to 3 times per day, 1000 to 3000 mg, and 2 to 3 times per day. It is preferable to use 1000 to 2000 mg once a day, and 2 to 3 times a day. This may be appropriately increased or decreased depending on the route of administration, age, sex, severity of symptoms, and the like. In the present invention, the composition of the present invention is administered to a subject or characterized by ingestion, and a method of modulating the activity of URAT1 according to the subject is also provided.
本發明之組成物之製品(醫藥品、醫藥部外用品、飲食品、試劑等)或其說明書係可附加使用於調節URAT1活性所使用之要旨標示者。在此，所謂的「於製品或說明書上附加標示」係指於製品之本體、容器、包裝等附加標示，或於揭示製品資訊的說明書、附加文件、宣傳物、其他印刷物等附加標示。於使用於調節URAT1活性所使用之要旨標示，可包含關於藉由投予或攝取本發明之組成物，調節URAT1活性之機制之資訊。 The product of the composition of the present invention (medicine, medical product, food, drink, reagent, etc.) or its instructions can be additionally used for the purpose of regulating the activity of URAT1. Here, the term "additional labeling on the product or the specification" refers to an additional label on the body, container, package, etc. of the product, or an additional label indicating the specification of the product information, additional documents, promotional materials, and other printed materials. Information on the mechanism used to modulate URAT1 activity by administering or ingesting a composition of the present invention may include information on the mechanism used to modulate URAT1 activity.
後述係藉由試驗例，更具體地說明本發明。 The present invention will be more specifically described below by way of test examples.
將5週齡之雌性Wistar Hannover/Rcc大鼠(日本 SLC)，分成2組，1組4隻，使各組的平均體重成大致相等。 5-week-old female Wistar Hannover/Rcc rat (Japan SLC), divided into 2 groups and 1 group of 4, so that the average body weight of each group is approximately equal.
進行經口投予，對照組為水，牛磺酸投予組係牛磺酸用量為100mg/kg。其24小時後，於戊巴比妥麻醉下剖腹，取出腎臟。使用RNeasy Mini Kit(Qiagen社製)，萃取Total RNA。使用High Capacity RNA-to-cDNA Master Mix(Applied Biosystems社製)，進行反轉錄，使用URAT1引子(Applied Biosystems社製)，以Real Time PCR法，測定腎臟中URAT1 mRNA量。 Oral administration was carried out, the control group was water, and the amount of taurine in the taurine administration group was 100 mg/kg. After 24 hours, the laparotomy was performed under pentobarbital anesthesia, and the kidneys were taken out. Total RNA was extracted using an RNeasy Mini Kit (manufactured by Qiagen). Reverse transcription was performed using High Capacity RNA-to-cDNA Master Mix (Applied Biosystems), and the amount of URAT1 mRNA in the kidney was measured by Real Time PCR using a URAT1 primer (Applied Biosystems).
對照組之URAT1 mRNA量之平均值為100時之對照組及牛磺酸投予組之URAT1 mRNA量之平均值及標準誤差如表1所示。其結果與對照組比較，牛磺酸投予組之URAT1 mRNA量有意義地降低(p<0.05)。 The average and standard error of the URAT1 mRNA amount in the control group and the taurine administration group when the average value of the URAT1 mRNA in the control group was 100 are shown in Table 1. As a result, compared with the control group, the amount of URAT1 mRNA in the taurine administration group was significantly decreased (p<0.05).
本發明係可提供作為醫藥品、醫藥部外用品、或特定保健用食品(經健康增進法第26條第1項許可或第29條第1項之承認，標示對於於飲食生活中以特定的保健目的而攝取者，藉由該攝取而可期待該保健目的之要旨之食品)等之經許可標示特定機能之機能性食品等。 The present invention can be provided as a pharmaceutical, an external product of the Ministry of Medicine, or a food for a specific health care (subject to the permission of Article 26(1) of the Health Promotion Act or the recognition of Article 29, Item 1, which is specific to the eating and drinking life. For the purpose of the health care, the ingestible person, the food which can be expected for the purpose of the health care by the ingestion, and the like, the functional food of the specific function, etc.
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