JP2015500231A - 高脂血症を予防または治療するための医薬組成物 - Google Patents
高脂血症を予防または治療するための医薬組成物 Download PDFInfo
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Abstract
Description
(1)試験方法
雄性ニュージーランド白色家兎を試験動物として使用した。G1群の動物(陰性コントロール群、n=4)を除くすべての動物に対し、放射線照射により滅菌した高コレステロール血症飼料、すなわちDYET#620007(1%コレステロール含有固形飼料Purina #5321、 Dyets,Inc., Bethlehem, PA 18017)をCentral Lab. Animal Inc.から購入して給餌した。高コレステロール血症を誘発するために、該飼料を試験動物に8週間以上給餌した。試験動物から血液サンプルを採取した後、血清生化学的分析を実施した。総コレステロールレベルが約870mg/dLである動物をコレステロール血症が誘発された動物として選択した。試験物質は、0.5%のカルボキシメチルセルロースナトリウムおよび1%のトウィーン80を含む生理食塩水に溶解し、4週間にわたって毎日1回、ラテックスカテーテルを備えた経口注射器を用いて胃内に直接投与した。試験群は、下記表1に示す通りである。
前記のようにして高コレステロール血症が誘発された動物におけるトリグリセリド濃度を以下の表2に示す。表2の値は、各群のトリグリセリド濃度の平均値(mg/dL)を示す。
(1)試験方法
雄性ニュージーランド白色家兎を試験動物として使用した。G1群の動物(陰性コントロール群)を除くすべての動物に対し、放射線照射により滅菌した高トリグリセリド血症および高コレステロール血症の飼料、すなわちDYET#621082(0.5%コレステロール、14%ココナツオイル、2%マルトースデキストリン含有固形飼料Purina #5321、Dyets、Inc.、Bethlehem、PA 18017)をSaeronbio Inc.から購入して給餌した。高トリグリセリド血症および高コレステロール血症を誘発するために、該飼料を試験動物に4週間以上給餌した。試験動物から血液サンプルを採取した後、血清生化学的分析を実施した。無処理群と比較して総コレステロールレベルおよびトリグリセリドレベルが有意に変化した動物を選択した。選択された動物を、総コレステロールレベルおよびトリグリセリドレベルに基づいて4群に分けた。このとき、いずれの群においても総コレステロールレベルおよびトリグリセリドレベルの平均値が実質的に同等となるようにした。試験物質は、0.5%カルボキシメチルセルロースナトリウムおよび1%トウィーン80を含む生理食塩水に溶解し、4週間にわたって毎日1回、ラテックスカテーテルを備えた経口注射器を用いて胃内に直接投与した。試験群は、下記表3に示す通りである。
前記のようにして高トリグリセリド血症および高コレステロール血症が誘発された動物におけるトリグリセリド濃度を以下の表4に示す。表4の値は、各群のトリグリセリド濃度の平均値(mg/dL)を示す。
Claims (12)
- 有効成分として下記式(1)の化合物またはその薬学的に許容される塩とアンジオテンシンII受容体遮断薬とを含む、高脂血症を予防または治療するための医薬組成物。
- 前記アンジオテンシンII受容体遮断薬が、オルメサルタンまたはその塩、オルメサルタンメドキソミルまたはその塩、テルミサルタンまたはその塩、ロサルタンまたはその塩、およびバルサルタンまたはその塩からなる群から選択される、請求項1に記載の医薬組成物。
- 前記アンジオテンシンII受容体遮断薬がオルメサルタンメドキソミルまたはその塩である請求項1に記載の医薬組成物。
- 前記高脂血症が高トリグリセリド血症または高トリグリセリド血症に関連する疾患である請求項1〜3のいずれかに記載の医薬組成物。
- 前記高トリグリセリド血症に関連する疾患がアテローム性動脈硬化症または膵炎である請求項4に記載の医薬組成物。
- 前記高脂血症が高コレステロール血症である請求項1〜3のいずれかに記載の医薬組成物。
- 前記高脂血症が複合型高脂血症である請求項1〜3のいずれかに記載の医薬組成物。
- 前記組成物が経口投与のための剤形に製剤化される請求項1〜3のいずれかに記載の医薬組成物。
- 前記経口投与のための剤形が、10〜300mg/日の投与に適した量の前記式(1)の化合物またはその薬学的に許容される塩を含む、請求項8に記載の医薬組成物。
- 前記経口投与のための剤形が、5〜320mg/日の投与に適した量の前記アンジオテンシンII受容体遮断薬を含む、請求項8に記載の医薬組成物。
- 高脂血症を予防または治療するための薬剤を製造するための、下記式(1)の化合物またはその薬学的に許容される塩とアンジオテンシンII受容体遮断薬とを含む有効成分の使用。
- 高脂血症の治療を必要とする患者に下記式(1)の化合物またはその薬学的に許容される塩の治療有効量とアンジオテンシンII受容体遮断薬の治療有効量とを投与することを含む、高脂血症の治療方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR20110126431 | 2011-11-30 | ||
KR10-2011-0126431 | 2011-11-30 | ||
PCT/KR2012/010170 WO2013081372A1 (en) | 2011-11-30 | 2012-11-28 | Pharmaceutical composition for preventing or treating hyperlipidemia |
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JP2015500231A true JP2015500231A (ja) | 2015-01-05 |
JP6108631B2 JP6108631B2 (ja) | 2017-04-05 |
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JP2014544661A Expired - Fee Related JP6030147B2 (ja) | 2011-11-30 | 2012-11-28 | 高トリグリセリド血症または高トリグリセリド血症に関連する疾患を予防または治療するための医薬組成物 |
JP2014544660A Expired - Fee Related JP6108631B2 (ja) | 2011-11-30 | 2012-11-28 | 高脂血症を予防または治療するための医薬組成物 |
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JP2014544661A Expired - Fee Related JP6030147B2 (ja) | 2011-11-30 | 2012-11-28 | 高トリグリセリド血症または高トリグリセリド血症に関連する疾患を予防または治療するための医薬組成物 |
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Country | Link |
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US (2) | US9486443B2 (ja) |
EP (2) | EP2785342A4 (ja) |
JP (2) | JP6030147B2 (ja) |
KR (2) | KR101436547B1 (ja) |
CN (2) | CN104053440B (ja) |
AU (2) | AU2012346754B2 (ja) |
BR (2) | BR112014012081A2 (ja) |
CA (2) | CA2857163A1 (ja) |
MX (2) | MX353660B (ja) |
PH (2) | PH12014501088A1 (ja) |
RU (2) | RU2604132C2 (ja) |
UA (2) | UA114492C2 (ja) |
WO (2) | WO2013081373A1 (ja) |
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CN113121331B (zh) * | 2019-12-31 | 2024-01-05 | 华创合成制药股份有限公司 | 具有环丙基的苯氧芳酸类化合物及其药学上可接受的盐,以及它们的制备方法和应用 |
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US6004925A (en) * | 1997-09-29 | 1999-12-21 | J. L. Dasseux | Apolipoprotein A-I agonists and their use to treat dyslipidemic disorders |
IL143949A0 (en) * | 1998-12-23 | 2002-04-21 | Searle Llc | Combinations of cholesteryl ester transfer protein inhibitors and fibric acid derivatives for cardiovascular indications |
US7129265B2 (en) * | 1999-04-23 | 2006-10-31 | Mason R Preston | Synergistic effects of amlodipine and atorvastatin metabolite as a basis for combination therapy |
EP1284723A4 (en) | 2000-04-19 | 2004-06-30 | Borody Thomas J | COMPOSITIONS AND METHODS FOR TREATING DISORDERS ASSOCIATED WITH HYPERLIPIDEMIA |
US7071210B2 (en) | 2002-07-02 | 2006-07-04 | Pfizer Inc. | CETP inhibitors in combination with antihypertensive agents and uses thereof |
DOP2005000123A (es) * | 2004-07-02 | 2011-07-15 | Merck Sharp & Dohme | Inhibidores de cetp |
HN2005000340A (es) * | 2004-07-02 | 2009-11-06 | Merck Sharp & Dohme | Inhibidores de cetp |
US7375112B2 (en) | 2005-01-05 | 2008-05-20 | Medicure International Inc. | Compounds and methods for regulating triglyceride levels |
EP2029560B1 (en) * | 2005-12-30 | 2013-04-24 | Merck Sharp & Dohme Corp. | 1,3-oxazolidin-2-one derivatives useeful as cetp inhibitors |
CA2681628C (en) * | 2007-03-16 | 2016-10-18 | Concert Pharmaceuticals, Inc. | Inhibitors of cholesterol ester transfer protein |
WO2010036600A1 (en) | 2008-09-24 | 2010-04-01 | Merck Sharp & Dohme Corp. | Pharmaceutical compositions of atorvastatin |
US8354454B2 (en) * | 2008-10-01 | 2013-01-15 | Merck Sharp & Dohme Corp. | Prodrugs of oxazolidinone CETP inhibitors |
CN101822836A (zh) * | 2010-02-02 | 2010-09-08 | 王丽燕 | 包含艾力沙坦酯的药物组合物 |
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