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黄体酮缓释凝胶的体外释放性质
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文章编号:(2003)01-0006-04,黄体酮缓释凝胶的体外释放性质
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    徐 晖1,李英剑1,严 志2,艾 莉3,董英杰3

    (1.沈阳药科大学药学院,辽宁 沈阳 110016,2. 国家药典委员会,北京 100061,3.辽宁省医药工业研究院,辽宁沈阳 110016)

    摘要:目的 研究黄体酮缓释凝胶的释放性质。方法 选择适当的释放溶剂和人工合成支持膜,采用标准的溶出度测定装置,研究黄体酮缓释凝胶的体外药物释放性质。结果 黄体酮凝胶具有明显的缓释作用,药物的释放符合一级过程。结论 这一方法简便、重现性好,适用于难溶性药物的半固体制剂的体外释放度测定。

    关键词:药剂学;药物释放;体外释放度测试;黄体酮凝胶;水不溶性药物;半固体制剂

    中图分类号:R94 文献标识码:A

    In vitro release properties of sustained-release progesterone gel formulation

    XU Hui1,LI Ying-jian 1,YAN Zhi2,AI li3,DONG Ying-jie3

    (1. School of Pharmacy, Shenyang Pharmaceutical Univeristy, Shenyang 110016, China; 2. Pharmacopoeia Commission of PRC, Beijing 100061, China; 3. Liaoning Institute of Pharmaceutical Industry, Shenyang 110016, China )

    Abstract:Objective To investigate the release of active ingredient form progesterone gel formulations. Methods An in vitro release test method (disk assembly method) was developed and validated by selecting appropriate release medium and synthetic support membrane, and by using the standard dissolution apparatus of paddle method. Results The in vitro release of progesterone from gel formulation shows sustained release characteristic, the release kinetics follows first order. Conclusion This method is simple, reproducible and useful for in vitro release test of semisolid dosage of water-insoluble drugs.

    Key words:pharmaceutics; drug release properties; in vitro drug release test; sustained-release progesterone gel; water insoluble drugs; semi-solid dosage form

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