罗红霉素片仿制药与原研药溶出行为一致性研究及溶出度方法的建立

目的建立罗红霉素片溶出度曲线测定方法,评价21家国内仿制药产品与原研药溶出曲线的相似性。方法建立有区分力的溶出曲线测定方法,并分别考察罗红霉素片仿制药和原研药在PH6.0溶出介质中的溶出情况,通过计算相似因子评价溶出曲线的相似性:对国产和原研罗红霉素片在酸中溶出量进行考察。结果在选定条件下,国内21家制药公司中9家产品与原研相似,其余不相似。结论该方法适用于罗红霉素片的溶出曲线测定,可为罗红霉素片的质量一致性评价提供参考。

Study on consistency of the dissolution behaviors of generic and original preparations and establishment of method for dissolution of roxithromycin tablets

Objective To establish a new method for the dissolution curve determination of roxithromycin tablet, and evaluate the comparability of dissolution curves of 21 domestic generic tablets and the original tablet. Methods A distinguishing method for dissolution curve tests was established, the dissolution behaviors of generic and original preparations of roxithromycin were detected under the chosen condition, and the dissolution curves of consistency were evaluated by calculating the similarity factor (f2). The dissolution of roxithromycin tablets in acid media were tested. Results The products from nine domestic pharmaceutical companies were all in line with the original tablet in the dissolution curve similarities, compared to the other samples showing differences from original preparation. Conclusion The new dissolution method is suitable for the dissolution curve determination of roxithromycin tablets, making a reference for further quality consistency