普通口服固体制剂溶出度试验研究中需关注的问题  

Considerations of the dissolution test for oral solid dosage forms

作　　者：张宁[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国新药杂志》2013年第22期2607-2610,共4页Chinese Journal of New Drugs

摘　　要：溶出度试验对于口服固体制剂的开发和质量控制具有重要意义,其既是处方工艺的筛选工具,也是质量控制工具,为口服固体制剂研究中的一项重要内容。开展溶出度试验,首先需建立适宜的溶出条件,包括溶出装置、介质种类和体积、转速;其次,要开展适宜的溶出度比较研究,包括自研样品同原研产品溶出行为的比较、创新药研究进程中不同阶段样品溶出行为的比较、上市后变更前后样品溶出行为的比较以及不同规格样品溶出行为的比较。再者要注意记录关键批次样品的溶出行为;为质量标准的制定提供依据,为后续工艺验证批次、变更后批次的溶出度比较提供对比依据。To oral solid dosage forms, dissolution test is a common characterization test used to guide for- mulation design and control product quality. When the dissolution test is carried out, the first point is to develop suitable operating conditions, which should not to be too violent in general, can discriminate products of different quality and at the same time show robustness. The second point is that appropriate dissolution profiles should be compared, including comparisons between generics and the origir,ators, different formulations for phase I, phase II and phase III, products before and after change. The third point is that dissolution profiles of pivotal clinical trial batches should be recorded, which can be used to set the dissolul：ion limit and act as the standard of comparison for follow-up validation batches and after-change batches.

关 键 词：口服固体制剂 溶出度试验 溶出条件 溶出行为 

分 类 号：R95[医药卫生—药学]