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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 the difference of in vitro dissolution rate of Tropilirol hydrochloride in Naoluotong capsules from different manufacturers. Methods: The dissolution of Tropolol Hydrochloride in 42 different batches of 27 capsules of 27 manufacturers was determined by the basket method. The cumulative dissolution rate was calculated. The similarity of the dissolution curves was evaluated by the difference factor and similar factor method. Tolperisone hydrochloride was determined by HPLC. The mobile phase was acetonitrile-0.05 mol·L-1 potassium dihydrogen phosphate (25:75) and the detection wavelength was 261 nm. Results: 1mol·L-1 hydrochloric acid solution was selected as the dissolution medium at 125 r · min-1. Most of the different manufacturers of Naoluo Tong capsule in 15 min, Tolperisone hydrochloride has been basically dissolved, marked the amount of> 95%, but a small number of manufacturers of product dissolution is low. CONCLUSION: There are some differences in the dissolution rate of TDP from different manufacturers. It is suggested that the standard of evaluation of dissolution should be formulated strictly.