药物溶出度试验方法研究进展  

Progress of dissolution test methodologies

作　　者：魏农农[1] 王霞[2] 苏敏[2] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038 [2]第三军医大学药学院&药物研究所,重庆400038

出　　处：《中国新药杂志》2013年第10期1119-1124,共6页Chinese Journal of New Drugs

基　　金：重庆市科技攻关项目(CSTS2010AC5027)

摘　　要：随着制药行业以及监管机构对药品质量问题的日益关注,溶出度试验成为了药品质量的关键检查项目以及药品注册中不可缺少的指标。溶出度指的是药物在规定的介质中从片剂或胶囊剂等固体制剂中溶出的速度和程度。溶出度不仅可以用于对药物在动物体内生物利用度进行预测,而且是对药物研发和批次间质量控制的一种重要而很有价值的工具。药品生产安全的全球化进程不断促进着溶出试验方法和技术的普及及创新,本文主要围绕溶出度试验方法和技术阐述溶出度的试验方法、溶出度的测定方法以及溶出度仪的研究进展。As pharmaceutical industry and regulatory agencies are increasingly concerned with drug quali- ty,in vitro dissolution test becomes one of the key items of drug quality standards. Dissolution refers to the in vitro release of tablets, capsules, or other solid preparations in selected media. Dissolution can not only predict drug＇s bioavailability, but also estimate the deviation between different batches, so it is exploited as a very valuable tool for drug quality control. The globalization of the issue of drug safety has promoted the popularization and innovation of dissolution test methods. In this paper, the recent progress of dissolution test methods and techniques is briefly reviewed.

关 键 词：溶出度 生物利用度 生物等效性 固体制剂 

分 类 号：R969[医药卫生—药理学] R945[医药卫生—药学]