JP2008069127A - 消炎鎮痛クリーム製剤及びその製造方法 - Google Patents
消炎鎮痛クリーム製剤及びその製造方法 Download PDFInfo
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- JP2008069127A JP2008069127A JP2006250949A JP2006250949A JP2008069127A JP 2008069127 A JP2008069127 A JP 2008069127A JP 2006250949 A JP2006250949 A JP 2006250949A JP 2006250949 A JP2006250949 A JP 2006250949A JP 2008069127 A JP2008069127 A JP 2008069127A
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- water
- biphenylacetic acid
- inflammatory analgesic
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Abstract
【解決手段】 4−ビフェニル酢酸、N−メチル−2−ピロリドン、水溶性高分子、界面活性剤、pH調整剤及び水を含有し、pHが5.5〜6.5であることを特徴とする消炎鎮痛クリーム製剤。
【選択図】 なし
Description
(i)前記微結晶状態の4−ビフェニル酢酸の平均粒子径が5〜100μmの状態、及び/又は、
(ii)前記微結晶状態の4−ビフェニル酢酸が200μm以下の粒子径を有するもののみである状態、
で経時的に安定して維持されるようになる。
(i)前記微結晶状態の4−ビフェニル酢酸の平均粒子径が5〜100μmの状態、及び/又は、
(ii)前記微結晶状態の4−ビフェニル酢酸が200μm以下の粒子径を有するもののみである状態、
であることが好ましい。そして、本発明の消炎鎮痛クリーム製剤においては、密封状態で40℃の条件下で1ヶ月保存した後においても、前記4−ビフェニル酢酸の一部が微結晶状態で分散しており、前記(i)及び(ii)の状態が維持されるようになる。
スクワラン3.0質量部、トリ(カプリル・カプリン酸)グリセリド3.0質量部、l−メントール3.0質量部、N−メチル−2−ピロリドン5.0質量部、ポリオキシエチレンショ糖脂肪酸エステル3.0質量部及びメチルパラベン0.2質量部を70℃に加温して溶解せしめ、得られた油相成分を67.8質量部の精製水に投入して攪拌し、乳化液を得た。次に、得られた乳化液に、カルボキシビニルポリマー1.0質量部と微粉砕状態(平均粒子径:約70μm)の4−ビフェニル酢酸3.0質量部とを10質量部の精製水に分散せしめた水分散液を添加して混合し、更にジエタノールアミン1.0質量部を加えて混合して、本発明の消炎鎮痛クリーム製剤を得た。
ジエタノールアミンの配合量を1.1質量部に、油相成分を投入する精製水の量を67.7質量部にそれぞれ変更した以外は実施例1と同様にして本発明の消炎鎮痛クリーム製剤を得た。
ジエタノールアミンの配合量を1.2質量部に、油相成分を投入する精製水の量を67.6質量部にそれぞれ変更した以外は実施例1と同様にして本発明の消炎鎮痛クリーム製剤を得た。
ジエタノールアミンの配合量を1.3質量部に、油相成分を投入する精製水の量を67.5質量部にそれぞれ変更した以外は実施例1と同様にして比較のための消炎鎮痛クリーム製剤を得た。
ジエタノールアミンの配合量を1.4質量部に、油相成分を投入する精製水の量を67.4質量部にそれぞれ変更した以外は実施例1と同様にして比較のための消炎鎮痛クリーム製剤を得た。
ジエタノールアミンの配合量を1.6質量部に、油相成分を投入する精製水の量を66.2質量部にそれぞれ変更すると共にカルボキシビニルポリマーの配合量を2.0質量部に変更した以外は実施例1と同様にして比較のための消炎鎮痛クリーム製剤を得た。
各実施例及び各比較例で得られた消炎鎮痛クリーム製剤を用いて、以下の方法及び基準により使用感(製剤の扱いやすさ、べたつき、よれの発生)を評価した。得られた結果を表2に示す。
○:「(i)扱いやすかった」が65%以上
△:「(i)扱いやすかった」が35%超65%未満
×:「(i)扱いやすかった」が35%以下。
○:「(i)べたつかない」が65%以上
△:「(i)べたつかない」が35%超65%未満
×:「(i)べたつかない」が35%以下。
○:「(i)よれの発生がなかった」が65%以上
△:「(i)よれの発生がなかった」が35%超65%未満
×:「(i)よれの発生がなかった」が35%以下。
各実施例及び各比較例で得られた消炎鎮痛クリーム製剤を樹脂製チューブ(容量20g)に入れて密封した状態で40℃の条件下で1ヶ月保存し、製造直後の初期における4−ビフェニル酢酸の結晶状態、1週間保存後における4−ビフェニル酢酸の結晶状態、1ヶ月保存後における4−ビフェニル酢酸の結晶状態をそれぞれ偏光顕微鏡を用いて観察した。実施例1〜3及び比較例1〜3で得られた消炎鎮痛クリーム製剤についての偏光顕微鏡写真をそれぞれ図1〜6に示す。なお、図1〜6中、(a)は製造直後の初期、(b)は1週間保存後、(c)は1ヶ月保存後における結果である。
Claims (9)
- 4−ビフェニル酢酸、N−メチル−2−ピロリドン、水溶性高分子、界面活性剤、pH調整剤及び水を含有し、pHが5.5〜6.5であることを特徴とする消炎鎮痛クリーム製剤。
- 前記製剤の全量を基準として、前記4−ビフェニル酢酸の含有量が0.5〜5質量%、前記N−メチル−2−ピロリドンの含有量が0.5〜10質量%、前記水溶性高分子の含有量が0.1〜5質量%、前記界面活性剤の含有量が0.5〜10質量%であることを特徴とする請求項1に記載の消炎鎮痛クリーム製剤。
- 前記製剤の全量を基準として2〜20質量%の油性物質を更に含有することを特徴とする請求項2に記載の消炎鎮痛クリーム製剤。
- 前記油性物質として、スクワラン及び/又は中鎖脂肪酸トリグリセリドを含有することを特徴とする請求項3に記載の消炎鎮痛クリーム製剤。
- 前記4−ビフェニル酢酸の少なくとも一部が前記製剤中に微結晶状態で分散しており、前記微結晶状態の4−ビフェニル酢酸の平均粒子径が5〜100μmであることを特徴とする請求項1〜4のうちのいずれか一項に記載の消炎鎮痛クリーム製剤。
- 前記4−ビフェニル酢酸の少なくとも一部が前記製剤中に微結晶状態で分散しており、前記微結晶状態の4−ビフェニル酢酸が200μm以下の粒子径を有するもののみであることを特徴とする請求項1〜5のうちのいずれか一項に記載の消炎鎮痛クリーム製剤。
- 密封状態で40℃の条件下で1ヶ月保存した後において、前記4−ビフェニル酢酸の少なくとも一部が前記製剤中に微結晶状態で分散しており、前記微結晶状態の4−ビフェニル酢酸の平均粒子径が5〜100μmであり、且つ、前記微結晶状態の4−ビフェニル酢酸が200μm以下の粒子径を有するもののみであることを特徴とする請求項1〜6のうちのいずれか一項に記載の消炎鎮痛クリーム製剤。
- N−メチル−2−ピロリドン及び界面活性剤を含有する油相成分と水を含有する水相成分とを混合し、得られた乳化液に水溶性高分子と微粉砕状態の4−ビフェニル酢酸と水とを添加及び混合し、更にpH調整剤を添加して得られる製剤のpHを5.5〜6.5に調整してなるものであることを特徴とする請求項1〜7のうちのいずれか一項に記載の消炎鎮痛クリーム製剤。
- N−メチル−2−ピロリドン及び界面活性剤を含有する油相成分と水を含有する水相成分とを混合し、得られた乳化液に水溶性高分子と微粉砕状態の4−ビフェニル酢酸と水とを添加及び混合し、更にpH調整剤を添加して得られる製剤のpHを5.5〜6.5に調整することを特徴とする消炎鎮痛クリーム製剤の製造方法。
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CN104262138A (zh) * | 2014-08-22 | 2015-01-07 | 湖北美林药业有限公司 | 一种联苯乙酸化合物及其药物组合物 |
JP2015214581A (ja) * | 2015-08-07 | 2015-12-03 | 小林製薬株式会社 | 皮膚外用剤 |
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