酒石酸美托洛尔片仿制与原研的溶出度比较

发布时间：2018-03-16 19:11

本文选题：酒石酸美托洛尔片　切入点：仿制药　出处：《海峡药学》2016年03期 　论文类型：期刊论文

【摘要】：目的对酒石酸美托洛尔片国产仿制药与原研药进行体外溶出度比较,为质量一致性评价提供依据。方法参照中国药典2010版二部酒石酸美托洛尔片的质量标准,选取50mg规格样品,采用4种不同的溶出介质对国内8家企业生产的仿制药和原研药进行体外溶出行为考察,并采用差异因子f_1法、相似因子f_2法和直接比较法来评价仿制药与原研药溶出行为的一致性。结果 8家仿制药溶出行为参差不齐,按直接比较法只有1家仿制药在四种溶出介质中的溶出曲线均与原研药一致,只在两种或一种溶出介质中的溶出曲线与原研药一致的情况较多。结论国内企业生产的酒石酸美托洛尔片仿制药与原研药存在体外溶出行为不一致性,处方、制剂工艺、辅料的选用方面需要进一步研究,以达到仿制药与原研药体外溶出行为一致性和质量一致性。同时,要结合生物等效性试验,对该品种的国产仿制药和原研药的一致性作出综合的评价。
[Abstract]:Objective to compare the dissolution of metoprolol tartrate tablets in vitro and to provide a basis for quality consistency evaluation. Methods according to the quality standard of metoprolol tartrate tablets in Chinese Pharmacopoeia 2010, 50mg samples were selected. In this paper, four different dissolution media were used to investigate the dissolution in vitro of the generic and original drugs produced by 8 domestic enterprises, and the difference factor f1 method was used. The similarity factor f2 method and direct comparison method were used to evaluate the consistency of drug dissolution behavior between generic drugs and original drugs. According to the direct comparison method, only one generic drug has the same dissolution curve in the four kinds of dissolution media as the original drug. The dissolution curves in two or one dissolution medium are consistent with the original drugs. Conclusion there is in vitro dissolution behavior inconsistency between metoprolol tartrate tablets produced by domestic enterprises, prescription and preparation process. Further research is needed on the selection of excipients in order to achieve consistency of dissolution behavior and quality between generic and original drugs in vitro. At the same time, it is necessary to combine the bioequivalence test, The consistency of domestic generic drug and original drug was evaluated synthetically.
【作者单位】：中国药科大学药学院药物分析教研室;江苏省食品药品监督检验研究院;
【分类号】：R927.1

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