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皮肤外用半固体化学仿制药药学研究现状与思考

李珊珊 孙影 申丽先 谢琰

药学研究2026,Vol.45Issue(8):884-889,922,7.
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药学研究2026,Vol.45Issue(8):884-889,922,7.DOI:10.13506/j.cnki.jpr.2026.08.007

皮肤外用半固体化学仿制药药学研究现状与思考

Current status and reflections on pharmaceutical research of generic topical semisolid preparations

李珊珊 1孙影 1申丽先 1谢琰1

作者信息

  • 1. 国家药品监督管理局药品审评中心,北京 100163
  • 折叠

摘要

Abstract

Due to complex formulation and manufacturing processes as well as multiphase instability,topical semisolid preparations are considerably more difficult to research than conventional preparations.With the continuous improvement of domestic regulatory systems,generic topical semisolid chemical preparations have become a hotspot in research and application.This paper systematically reviewed the domestic marketing status,relevant technical requirements,and considerations in pharmaceutical research,focusing on ointments,creams,and gels,aiming to provide references for optimizing research and development strategies,and promoting high-quality development of generic drugs.

关键词

半固体/化学仿制药/药学研究

Key words

Semisolid/Generic chemical drugs/Pharmaceutical research

分类

医药卫生

引用本文复制引用

李珊珊,孙影,申丽先,谢琰..皮肤外用半固体化学仿制药药学研究现状与思考[J].药学研究,2026,45(8):884-889,922,7.

药学研究

2095-5375

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