《中国药典》中溶出度检查方法的商榷

Discussion of the methods about dissolution test in Chinese Pharmacopoeia

目的剖析《中国药典》2010年版二部中某些药品溶出度/释放度检查项目中的问题,并就正文及附录中溶出度/释放度的检查方法进行探讨。方法查阅经胃肠吸收的所有固体制剂的溶出度检查内容及附录中溶出度/释放度的检查方法,发现问题并就部分相关项目与美国和英国药典进行比较。结果正文某些药品溶出度/释放度检查内容中存在书写错误和操作欠规范等问题,药品溶出度/释放度的检查方法中的一些规定和要求值得商榷。结论《中国药典》2010年版二部应当进一步完善药品溶出度/释放度检查方法。

Objective To point out some problems of drug dissolution or release tests, and to discuss the methods in Chinese Pharmacopoeia 2010, ⅡPart. Methods The items of dissolution test on solid dosage forms for oral and appendix method rules were analyzed carefully. The items were compared with US Pharmacopoeia and British Pharmacopoeia. Results There are some wrong in writing and not proper operation description in dissolution or release tests. It is necessary to discuss about the regulations in dissolution or release tests. Conclusion The methods of drug dissolution or release tests should be corrected.