皮肤科药物研发中的若干问题解析

发布时间：2018-04-15 04:35

本文选题：皮肤科 + 外用药物　；参考：《中国新药杂志》2017年18期

【摘要】：皮肤外用制剂多为半固体制剂,具有多相、热力学不稳定等特点,辅料多样且筛选过程复杂,多需进行体外透皮吸收试验加以评价,与常规注射、固体制剂的评价有显著差异。本文结合实际审评经验,对局部外用皮肤科药物的科学处方开发、原辅料的来源和控制、杂质分析的特点和技术要求、透皮吸收试验的设计与评价、稳定性研究的特点等技术关键点进行汇总和分析,希望有助于当前皮肤科药物的研发和评价。
[Abstract]:The skin preparations for external use are mostly semisolid preparations with the characteristics of multiphase thermodynamics instability and so on. The excipients are various and the screening process is complex. It needs to be evaluated by in vitro transdermal absorption test and there is a significant difference from the conventional injection and the evaluation of solid preparations.In this paper, the scientific prescription development of local external dermatologic drugs, the source and control of raw materials, the characteristics and technical requirements of impurity analysis, the design and evaluation of transdermal absorption test are discussed.The characteristics of stability research and other technical key points are summarized and analyzed in order to contribute to the current research and evaluation of dermatologic drugs.
【作者单位】：国家食品药品监督管理总局药品审评中心;
【分类号】：R986

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