外用半固体制剂的体外释放试验和等效性评价  

In Vitro Release Tests and Equivalence Evaluation for Topical Semisolid Dosage Forms

作　　者：邵鹏 郑金琪 潘芳芳 梁文权[3] 高建青[3] 洪利娅 SHAO Peng;ZHENG Jinqi;PAN Fangfang;LIANG Wenquan;Gao Jianqing;HONG Liya(Zhejiang Institute for Food and Drug Control,Hangzhou 310052,China;NMPA Key Laboratory for Core Technology of Generic Drug Evaluation,Hangzhou 310052,China;College of Pharmaceutial Sciences,Zhejiang University,Hangzhou 310058,China)

机构地区：[1]浙江省食品药品检验研究院,杭州310052 [2]国家药品监督管理局仿制药评价关键技术重点实验室,杭州310052 [3]浙江大学药学院,杭州310058

出　　处：《中国现代应用药学》2021年第20期2481-2487,共7页Chinese Journal of Modern Applied Pharmacy

摘　　要：外用半固体制剂包括乳膏剂、软膏剂和凝胶剂等。药物活性成分(active pharmaceutical ingredient,API)的释放对于外用半固体制剂的质量影响至关重要,药物释放在很大程度上取决于其配方组成和制备过程。体外释放试验(invitro release test,IVRT)可用来评估API的释放速率,检测由于制剂变化或API理化性质的差异而可能引起的释放速率之间的不同。已有大量研究表明,IVRT方法参数的差异会影响IVRT结果,因此保持IVRT方法参数的一致性才能保证结果的可靠。本文讨论了IVRT方法开发和验证,及关于半固体制剂仿制药等效性评价的实验和数据统计分析方法。Topical semisolid dosage forms include cream,ointment and gel.The release of active pharmaceutical ingredient(API)is of critical importance for the quality of topical semisolid drug products.Their drug release depends largely on the formulation and manufacturing process.In vitro release test(IVRT)can be used to evaluate the release rate of API,and to detect the difference between the release rate that may be caused by the changes in the formulation and the differences in the physical and chemical properties of API.A large number of studies have shown that differences in IVRT method parameters will affect the IVRT results,so the consistency of the IVRT method parameters can ensure the reliability of the results.This article discusses development and verification of IVRT method,the experimental procedures and data statistical analysis methods for the equivalence evaluation of generic semisolid dosage forms.

关 键 词：半固体制剂 体外释放试验 等效性 扩散池 统计分析 

分 类 号：R944[医药卫生—药剂学]