皮肤局部外用制剂Q3等同性研究技术要点解析  

Analysis of Technical Points on Topical Dermatologic Drugs for Q3 Equivalence Study

作　　者：武余波[1] 黄乐乐[1] 卢望丁 朱慧勇[1] 马晋隆[1] 罗华菲[1] 倪睿[1] WU Yubo;HUANG Lele;LU Wangding;ZHU Huiyong;MA Jinlong;LUO Huafei;NI Rui(National Pharmaceutical Engineering Research Center,China State Institute of Pharmaceutical Industry,Shanghai 201203)

机构地区：[1]中国医药工业研究总院药物制剂国家工程研究中心,上海201203

出　　处：《中国医药工业杂志》2022年第5期601-610,共10页Chinese Journal of Pharmaceuticals

摘　　要：皮肤局部外用制剂中,半固体制剂、混悬制剂较多,相比于传统的口服固体制剂和注射制剂,存在着多相、药物释放动力学和降解热力学不规律、一般无系统吸收等诸多特点,使得研发过程和技术评价更为复杂。本研究参考FDA、EMA和我国药品审评中心发布的相关技术指导原则及文献,就皮肤局部外用制剂Q3等同性研究中的关键质量属性、体外释放试验和体外透皮试验的评价方法做详细的技术要点解析,以期为仿制药体外一致性评价提供参考。Compared with oral and injectable formulations,it is much more complicated in semisolid and suspension formulations for topical usage from the technical points of view.Due to the characteristics of multiple phases,irregular drug release kinetics and degradation thermodynamics,and generally without systemic absorption,the formulation development and characterization of topical semisolid drug products are facing challenges.Referring to the relevant technical guidelines issued by FDA,EMA and Center for Drug Evaluation of China as well as literature,this paper analyzes the key technical points on topical dermatologic drugs for Q3 equivalence study,including the critical quality attributes,in vitro release test(IVRT)and in vitro permeation test(IVPT),hoping to provide some references for in vitro consistency of generic drugs.

关 键 词：皮肤局部外用药 局部用药分类系统 Q3等同性 体外一致性评价 体外释放试验 体外透皮试验 

分 类 号：R944.9[医药卫生—药剂学]