JP2007204437A - 外用製剤及びその製造方法 - Google Patents
外用製剤及びその製造方法 Download PDFInfo
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- JP2007204437A JP2007204437A JP2006026034A JP2006026034A JP2007204437A JP 2007204437 A JP2007204437 A JP 2007204437A JP 2006026034 A JP2006026034 A JP 2006026034A JP 2006026034 A JP2006026034 A JP 2006026034A JP 2007204437 A JP2007204437 A JP 2007204437A
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- ketoprofen
- dibutylhydroxytoluene
- external preparation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Landscapes
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Abstract
【解決手段】1〜7質量%のケトプロフェン及び2.1〜10質量%のジブチルヒドロキシトルエンを含有し、ケトプロフェンに対するケトプロフェンメチルエステルの生成率がケトプロフェン質量に換算して0.2%以下である外用製剤。この外用製剤は、ジブチルヒドロキシトルエンを予め加熱した後、ケトプロフェンと混合することを特徴とする製造方法による製造される。
【選択図】なし
Description
カルボキシビニルポリマー2重量部を精製水25重量部に膨潤させた。これに、エタノール40重量部及びジイソプロピルアジベート2重量部にケトプロフェン3重量部、及び予め加熱し不純物を取り除いたジブチルヒドロキシトルエン2.1重量部を溶解させた溶液を加え攪拌した。さらに、これにヒドロキシプロピルセルセロケース2重量部をプロピレングリコール15重量部に溶解させた溶液を加え攪拌した後、ジイソプロパノールアミン2.5重量部を精製水6.4部に溶解させたものを加え、全体が均一になるまで十分攪拌することによりゲル剤を得た。
ケトプロフェン7重量部をエタノール50重量部に溶解せしめ、その中に予め加熱し、不純物を取り除いたジブチルヒドロキシトルエン3重量部を加えた。次にジイソプロピルアジベート40重量部を加え、全体が均一になるよう十分に攪拌することにより、リニメント剤を得た。
ケトプロフェン1重量部、4−tert−ブチル−4’−メトキシジベンゾイルメタン0.5重量部、セバシン酸ジエチル10重量部、鯨ロウ5重量部、ポリオキシエチレンラウリルエーテルリン酸ナトリウム2重量部、白色ワセリン78.95重量部、パラオキシ安息香酸ブチル0.05重量部、及び予め加熱し不純物を取り除いたジブチルヒドロキシトルエン2.5重量部を配合し、加熱融解させた後、40〜100℃に保った。融解液が透明になった後、ホモミキサーで全体が均一になるよう混合した。その後攪拌しながら室温まで冷却することにより軟膏剤を得た。
カルボキシビニルポリマー1重量部を水62.9重量部に膨潤させ、膨潤物Aを得た。一方、ミリスチン酸イソプロピル10重量部とエタノール5重量部及び2−ヒドロキシ−4−メトキシベンゾフェノン0.8重量部を混合し、これにケトプロフェン3重量部を溶解させた後、更に、ポリエチレングリコールモノステアレート1重量部、パラオキシ安息香酸メチル0.2重量部を混合し、予め加熱し不純物を取り除いたジブチルヒドロキシトルエン2.1重量部を配合した。これに膨潤物Aを添加し、ホモミキサーで均一に乳化した。乳化後、ヤシ油脂肪酸ジエタノールアミド3重量部を水11重量部に溶解させたものを添加し、全体が均一になるまで十分に攪拌することによりクリーム剤を得た。
ゼラチン5重量部、ソルビトール10重量部、カオリン7重量部、精製水41.9重量部を混合機内に入れ、約50〜60℃にて溶解し、均一な分散液を得た。これに予め調製しておいたグリセリン25重量部、ポリアクリル酸ソーダ3重量部、カルボキシメチルセルロース3.5重量部の分散液を投入し、そして予め加熱し不純物を取り除いたジブチルヒドロキシトルエン2.1重量部を配合し攪拌練合し、均一な練合物Bを得た。また、水浴上にてクロタミトン1重量部、2−ヒドロキシ−4−メトキシベンゾフェノン0.5重量部及びケトプロフェン1重量部を加温混合攪拌し、均一な溶解液Cを得た。次に練合物Bに溶解液Cを投入、攪拌し均一な練合物を得た。これを、展延機を用いて厚さ2mmに塗布した後、ポリプロピレンフィルムに覆い、所望の大きさに切断することにより湿布剤を得た。
スチレン−イソプレン−スチレンテレブロック共重合体12重量部、スチレン−イソプレン−スチレンラジアルテレブロック共重合体8重量部、水添ロジンエステル12重量部、ロジン変性マレイン酸樹脂3重量部、流動パラフィン55重量部を窒素ガス気流中で融解混合し、この融液(約150℃)を約120℃まで冷却した後、ケトプロフェン5重量部を及び2−ヒドロキシ−4−メトキシベンゾフェノン2.5重量部を添加、そして予め加熱し不純物を取り除いたジブチルヒドロキシトルエン2.5重量部を混合して均一なものとした。これを展延機を用いて不織布上に厚さ約50μmに展延した後、離型処理を施した剥離紙で覆い所望の大きさに切断することにより貼付剤を得た。
スチレン−イソプレン−スチレンブロック共重合体21重量部、ポリイソブチレン22重量部、水添ロジンエステル12重量部、流動パラフィン40重量部、ジブチルヒドロキシトルエン(ヨシノックスBHT、APIコーポレーション)3重量部を、窒素ガス雰囲気下110〜200℃の温度範囲で撹拌しながらケトプロフェン2重量部を添加し、更に5〜30分混合して均一な溶解物を得た。これを70cm2あたり1gとなるように、シリコーン処理したポリエステルフィルムに展延し、支持体を積層することにより貼付剤を得た。
スチレン−イソプレン−スチレンブロック共重合体21重量部、ポリイソブチレン22重量部、水添ロジンエステル12重量部、流動パラフィン40重量部、ジブチルヒドロキシトルエン(BHTタケダ、武田キリン食品)3重量部を、窒素ガス雰囲気下110〜200℃の温度範囲で撹拌しながらケトプロフェン2重量部を添加し、更に5〜30分混合して均一な溶解物を得た。この溶解物を70cm2あたり1gとなるように、シリコーン処理したポリエステルフィルムに展延し、支持体を積層することにより貼付剤を得た。
スチレン−イソプレン−スチレンブロック共重合体21重量部、ポリイソブチレン22重量部、水添ロジンエステル12重量部、流動パラフィン40重量部を、窒素ガス雰囲気下110〜200℃の温度範囲で撹拌しながらケトプロフェン2重量部、ジブチルヒドロキシトルエン(ヨシノックスBHT、APIコーポレーション)3重量部を添加し、更に5〜30分混合して均一な溶解物を得た。これを70cm2あたり1gとなるように、シリコーン処理したポリエステルフィルムに展延し、支持体を積層することにより、比較の為の貼付剤を得た。
貼付剤の場合、製剤1枚(70cm2)を取り、質量を精密に量り、テトラヒドロフラン40mLを加え、30分間超音波処理し、得られた抽出液にメタノールを加えて100mLとし、これをメタノールで5倍に希釈して試料液とした。得られた試料液につき、高速液体クロマトグラフを用い、下記条件でケトプロフェン(以下、KPという)を定量した。
貼付剤の場合、製剤0.5枚(35cm2)を取り、質量を精密に量り、テトラヒドロフラン40mLを加え、30分間超音波処理し、得られた抽出液にメタノールを加えて50mLとし、これをメタノールで50倍に希釈して試料液とした。得られた試料液につき、高速液体クロマトグラフを用い、下記条件でKPメチルエステルを定量した。
Claims (5)
- 1〜7質量%のケトプロフェン及び2.1〜10質量%のジブチルヒドロキシトルエンを含有し、ケトプロフェンメチルエステルの生成率が0.2%以下である外用製剤。
- 外用製剤が貼付剤である請求項1記載の外用製剤。
- 請求項1又は2記載の外用製剤の製造方法であって、ジブチルヒドロキシトルエンを予め加熱した後、ケトプロフェンと混合することを特徴とする製造方法。
- 請求項2に記載の貼付剤の製造方法であって、スチレン−イソプレン−スチレンブロック共重合体、ポリイソブチレン、水添ロジンエステル、流動パラフィン及ジブチルヒドロキシトルエンを不活性ガス雰囲気下で加熱撹拌し、続いてケトプロフェンを添加し、均一な溶解物を得る工程を含む、製造方法。
- 請求項2に記載の貼付剤の製造方法であって、スチレン−イソプレン−スチレンブロック共重合体、ポリイソブチレン、水添ロジンエステル、流動パラフィン及ジブチルヒドロキシトルエンを不活性ガス雰囲気下で加熱撹拌し、続いてケトプロフェンを添加し、均一な溶解物を得る工程と、均一な溶解物を支持体に展延塗布した後に剥離被覆物で覆う工程と、を含む、製造方法。
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