酒石酸美托洛尔片仿制药与原研药溶出曲线的相似性评价

发布时间：2018-07-03 18:44

本文选题：酒石酸美托洛尔片 + 溶出曲线　；参考：《中国药房》2017年09期

【摘要】：目的:建立酒石酸美托洛尔片的溶出度测定方法,并评价仿制药与原研药的质量一致性。方法:采用桨法,转速为50r/min,分别以p H 1.2盐酸溶液、p H 4.5醋酸盐缓冲液和p H 6.8磷酸盐缓冲液为溶出介质,用光纤药物溶出度实时测定仪以10 mm的测定光程,分别测定酒石酸美托洛尔片仿制药与原研药的溶出曲线,并采用相似因子(f~2)法评价二者溶出曲线的相似性。结果:在3种溶出介质中,酒石酸美托洛尔片仿制药与原研药的f2分别为80.5、66.8、69.4,说明二者溶出曲线具有相似性。结论:所建立的实时溶出度过程分析方法适用于酒石酸美托洛尔片的溶出度测定;仿制药与原研药的体外溶出行为具有相似性,故其质量一致性较好。
[Abstract]:Objective: to establish a method for determination of dissolution of metoprolol tartrate tablets and to evaluate the quality consistency between generic and original drugs. Methods: the propeller method was used, the rotation speed was 50 r / min, the pH 4.5 acetate buffer solution and the pH 6.8 phosphate buffer solution were used as the dissolution media, and the optical path was measured by 10 mm optical fiber real time instrument. The dissolution curves of metoprolol tartrate tablets were determined and the similarity of dissolution curves was evaluated by similarity factor (ff2) method. Results: the f2 values of metoprolol tartrate tablets in three kinds of dissolution media were 80.5 and 66.8% respectively, which indicated that the dissolution curves were similar between the two kinds of tablets. The results showed that the dissolution curve of metoprolol tartrate tablets was similar to that of metoprolol tartrate tablets. Conclusion: the established real-time dissolution process analysis method is suitable for the determination of dissolution of metoprolol tartrate tablets.
【作者单位】：新疆生产建设兵团医院药学部;新疆医科大学中心实验室;
【基金】：新疆生产建设兵团卫生局科技项目(No.兵卫发〔2014〕58号)
【分类号】：R927.2

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