不同厂家卡托普利片在四种溶出介质中的溶出曲线比较研究  

Comparative Study on Dissolution Profiles of Captopril Tablets from Different Manufacturers in Four Dissolution Media

作　　者：赵霓[1] 

机构地区：[1]沈阳市食品药品检验所,沈阳110023

出　　处：《中国药师》2012年第6期845-847,共3页China Pharmacist

摘　　要：目的:比较6个厂家卡托普利片在四种溶出介质中的溶出曲线,为全面评价药品质量提供依据。方法:参考《中国药典》2010版卡托普利片测定方法,将转速改为50 r.min-1,测定了6个厂家卡托普利片在pH1.2、pH4.0、水和pH6.8四种溶出介质中的溶出曲线,并用f2因子法进行比较分析。结果:C厂的卡托普利片在四种溶出介质中均与参比制剂溶出曲线相似;A厂和D厂的卡托普利片在部分溶出介质中与参比制剂溶出曲线一致;B厂和E厂的卡托普利片在四种溶出介质中溶出曲线与参比制剂的差异均有统计学意义。结论:多数厂家与参比制剂溶出曲线有明显差异,建议与原创药溶出曲线不一致的相关厂家改进制剂的处方工艺以提高药品质量。Objective： To compare the dissolution profiles of captopril tablets from 6 manufacturers in 4 dissolution mediaand pro- vide the basis for the comprehensive quality evaluation of captopril tablets. Method： The dissolution profiles of captopril tablets in pill. 2, pH4.0, water and pH6.8 media were determined by the method described in Chinese Pharmacopoeia Vol. II （2010 edition） with the agitation speed of 50 r · min - 1. Result ： The 4 dissolution profiles of captopril tablets from manufacturer C were all similar to the reference preparation. Only several dissolution profiles of captopril tablets from manufacturer A and D were similar to the reference preparation. The dissolution profiles of captopril tablets from manufacturer B and E showed significant difference from that of the refer- ence preparation （f2 〈 50）. Conclusion： The dissolution profiles of captopril tablets from majority manufacturers were significant dif- ferent from that of the reference preparation, and the manufacturers should improve the quality by changing the formulation and prepara- tion process.

关 键 词：卡托普利片 溶出曲线 F2因子 

分 类 号：R917[医药卫生—药物分析学]