院内製剤ウリナスタチン膣坐剤の物理薬剤学的特性

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書誌事項

タイトル別名
  • Physicopharmaceutical Characteristics of Ulinastatin Vaginal Suppositories Prepared in Hospital
  • インナイ セイザイ ウリナスタチンチツザザイ ノ ブツリ ヤクザイガクテキ トクセイ

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抄録

  We studied a locally applied vaginal preparation (vaginal suppositories) of ulinastatin (urinary trypsin inhibitor, UTI), designed to threatened premature delivery and maintain pregnancy. Witepsol S55 was chosen as the basic component of the vaginal suppositories based on the physical pharmaceutical characteristics of three kinds of hard fats. The average particle size of the UTI aqueous injection was approximately 70% as compared with that of the UTI lyophilized product, used as the base material for the preparation of UTI vaginal suppositories. We compared the physical pharmaceutical properties of UTI vaginal suppositories with water contents of 2.5%, 5.0%, and 7.5%, respectively. Preparation strength negatively correlated with the water content. The coefficient of viscosity positively correlated with the water content of the preparation. UTI vaginal suppositories with a water content of 5.0% had the highest average drug release rate on moment analysis. A comprehensive evaluation of the properties of UTI vaginal suppositories, including high strength due to disintegration resistance, the coefficient of viscosity and its influence on local retention, and drug release and its influence on the duration of effect, indicated that a 5.0% UTI aqueous solution for injection combined with Witepsol S55 as the base was the optimal formulation for the hospital preparation of vaginal suppositories.<br>

収録刊行物

  • 薬学雑誌

    薬学雑誌 131 (11), 1639-1644, 2011-11-01

    公益社団法人 日本薬学会

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