皮肤和黏膜用半固体制剂体外释放试验技术规范专家共识

Expert Consensus on Technical Practice for the in Vitro Release Test of Topical Semisolid Dosage Forms for Skin and Mucous Membrane Preparations

关键词:  体外释放试验  半固体制剂  质量评价与控制  专家共识

Key words:  in vitro release test(IVRT)  semisolid dosage form  quality evaluation and control  expert consensus

摘要:

体外释放试验(in vitro release test，IVRT)是外用半固体制剂质量评价与控制的关键实验之一。已有一些国家的药品监管部门颁发了有关半固体制剂研究工作的指南，但对体外释放试验仍缺乏操作细则的描述。为了规范皮肤和黏膜用半固体制剂的体外释放试验，世界中医药学会联合会经皮给药专业委员会组织专家多次研讨，基于国际的要求和国内的实际，形成了本专家共识，供业界同行及监管部门参考。

Abstract:

The in vitro release test (IVRT) is critical to quality evaluation and control of topical semisolid dosage forms. The drug regulatory authorities of some countries have issued guidelines on the research of topical semisolid dosage forms. However, there is still a lack of description about operating details for IVRT. In order to standardize the IVRT of semisolid preparations for skin and mucosa, based on international and domestic practice, The Transdermal Drug Delivery Committee of the World Federation of Chinese Medicine Societies organized experts to discuss and form the consensus for reference by industry colleagues and regulators.