JP6781561B2 - プロピオン酸系非ステロイド性消炎鎮痛薬を含有した医薬組成物 - Google Patents
プロピオン酸系非ステロイド性消炎鎮痛薬を含有した医薬組成物 Download PDFInfo
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- JP6781561B2 JP6781561B2 JP2016061409A JP2016061409A JP6781561B2 JP 6781561 B2 JP6781561 B2 JP 6781561B2 JP 2016061409 A JP2016061409 A JP 2016061409A JP 2016061409 A JP2016061409 A JP 2016061409A JP 6781561 B2 JP6781561 B2 JP 6781561B2
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- propionic acid
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Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
(1)プロピオン酸系非ステロイド性消炎鎮痛薬、トラネキサム酸又はその塩、及びアンブロキソール又はその塩を含有する医薬組成物。
(2)プロピオン酸系非ステロイド性消炎鎮痛薬が、イブプロフェン又はロキソプロフェンナトリウム水和物である(1)に記載の医薬組成物。
(3)トラネキサム酸又はその塩が、トラネキサム酸である(1)または(2)に記載の医薬組成物。
(4)アンブロキソール又はその塩が、アンブロキソール塩酸塩である(1)乃至(3)のいずれか1に記載の医薬組成物。
(5)感冒用に用いられる(1)乃至(4)のいずれか1に記載の医薬組成物。
(1)被検物質
イブプロフェンはAlbemarle Corporation製のものを、トラネキサム酸は第一ファインケミカル製のものを、アンブロキソール塩酸塩は陽進堂製のものを、それぞれ使用した。媒体として、関東化学製のカルボキシメチルセルロースナトリウム(以下、CMCと称すことがある)を大塚製薬工場製の日局注射用水で希釈して0.5%としたCMC水溶液を使用した。被験薬は表1の通りであり、投与液量はいずれの群も同じ10ml/Kgとした。
4週齢のラット(Slc:SD)を日本エスエルシーより購入して、検疫・馴化した後に使用した。動物は22±3℃、湿度50±20%、照明時間8:00〜20:00の環境下で飼育馴化した。試験前日の夕方より16時間以上絶食させ、実験当日は朝より絶水した。絶食・絶水は起炎物質投与後5時間の足容積測定時まで継続した。
表3の被験薬を、ディスポーザブル経口ゾンデ(フチガミ器械製)を装着した注射筒に充填して同じ投与液量で10mL/Kg投与した。
起炎物質として、カラゲニン(和光純薬製)と注射用水(大塚製薬工場製)で1%カラゲニン生理食溶液を調製した。被験薬投与30分後に26Gの注射器(テルモ製)に充填した起炎物質0.1mLを右後肢皮下に投与した。
起炎物質投与前、起炎物質投与後3、4及び5時間の4時点について右後肢容積を、ラット用足容積測定装置(室町機械製)を用いて測定した。得られた足容積より、浮腫率を次式で求めた。また、浮腫率総和(AUC)は台形公式により算出した。
浮腫率(%)=100×(起炎物質投与後足容積−投与前足容積)/投与前足容積
浮腫率総和(AUC)の結果を図1に示す(n=5)。図より、被験薬B〜Gいずれも被験薬A群(媒体のみ)と有意な浮腫抑制効果が発現していることが認められた(Dunnett法:p<0.01)。
イブプロフェンとトラネキサム酸を併用(被験薬E)しても抗炎症効果の上乗せは発現しない。なお、アンブロキソールは優れた去痰作用を有する薬剤であり、感冒薬に配合できれば有用であるが、イブプロフェンとアンブロキソールの併用(被験薬F)では拮抗作用となりイブプロフェンの抗炎症作用が減弱するというさらに意外な結果が得られた。
一方、イブプロフェンとアンブロキソールの併用における拮抗作用は、更にトラネキサム酸を併用(被験薬G)することによって解消されることが判明した。本併用結果は、アンブロキソール群(被験薬D)よりも有意な浮腫抑制効果が発現していることが認められた($:t検定でp<0.05)。
(製剤例:錠剤)
下記成分および分量をとり、日局製剤総則「錠剤」の項に準じて錠剤を製造する。(成分量は1日量(mg))。
下記成分及び分量をとり、日局製剤総則「錠剤」の項に準じて製造した錠剤に、コーティングを施してコーティング製剤を製造する。(成分量は1日量(mg))。
下記成分及び分量をとり、日局製剤総則「錠剤」の項に準じて製造した錠剤に、コーティングを施して糖衣製剤を製造する。(成分量は1日量(mg))。
下記成分および分量をとり、日局製剤総則「顆粒剤」の項に準じて顆粒剤を製造する。(成分量は1日量(mg))。
Claims (4)
- イブプロフェン、トラネキサム酸又はその塩、及びアンブロキソール又はその塩を含有する医薬組成物。
- トラネキサム酸又はその塩が、トラネキサム酸である請求項1に記載の医薬組成物。
- アンブロキソール又はその塩が、アンブロキソール塩酸塩である請求項1または2に記載の医薬組成物。
- 感冒用に用いられる請求項1乃至3のいずれか1項に記載の医薬組成物。
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JP2008115167A (ja) * | 2006-10-12 | 2008-05-22 | Daiichi Sankyo Healthcare Co Ltd | トラネキサム酸を含有する気道杯細胞過形成抑制剤 |
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