DEAE纤维素纯化玉米须总多糖的工艺优选

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。

Optimization of Purification Process for Total Polysaccharides in Stigma Maydis with DEAE Cellulose

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 HCl 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.