不同厂家脑络通胶囊的体外溶出度考察  

Investigation of in vitro Dissolution of Naoluotong Capsules from Different Manufacturers

作　　者：郝虹[1] 于永洲[2] 顾利红[2] 李书渊[1] 

机构地区：[1]广东药学院中药学院,广州510006 [2]广州市药品检验所,广州510160

出　　处：《中国实验方剂学杂志》2014年第12期30-33,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家药品计划抽检项目(2012020046010)

摘　　要：目的:考察不同厂家的脑络通胶囊中盐酸托哌酮体外溶出度的差异。方法:采用篮法测定27个厂家42个不同批号的脑络通胶囊中盐酸托哌酮的溶出度,计算累积溶出率,采用差异因子和相似因子法评价溶出曲线的相似性。利用HPLC测定盐酸托哌酮含量,流动相乙腈-0.05 mol·L-1磷酸二氢钾(25∶75),检测波长261 nm。结果:选择1 mol·L-1盐酸溶液为溶出介质,转速125 r·min-1。不同厂家的脑络通胶囊大部分在15 min内盐酸托哌酮已基本溶出,标示量达>95%,但有少数厂家的产品溶出量较低。结论:不同厂家的脑络通胶囊中盐酸托哌酮溶出度存在一定差异,建议对该制剂制定严格的溶出度评价标准。Objective： To investigate difference among in vitro dissolution of tolperisone hydrochloride in Naoluotong capsules. Method： Dissolution of tolperisone hydrochloride in Naoluotong capsules from 27 different manufactures with 42 different batches was determined by the basket method, then cumulative dissolution rate was calculated, similarity of dissolution curves was evaluated with difference factor and similarity factor method. HPLC was adopted to determine the content of tolperisone hydrochloride with mobile phase of acetonitrile-0.05 mol·L-1 KH2PO4 （25：75） and detection wavelength at 261 nm. Result： Taking 1 mol·L-1 HC1 as dissolution medium with rotation rate of 125 r ·min-1. Naoluotong capsules from different manufactures were almost dissolved out at 15 min and tolperisone hydrochloride had reached of more than 95% compared with labeled amount, but products from a small number of manufacturers had low dissolution at the same time. Conclusion： There was significant difference in dissolution parameters of Naoluotong capsules from different pharmaceutical factories, suggesting that establish strict evaluation criteria for dissolution of tolperisone hydrochloride in this capsules.

关 键 词：脑络通胶囊 溶出度 盐酸托哌酮 溶出参数 

分 类 号：R283.6[医药卫生—中药学] R944.5[医药卫生—中医学]