阿奇霉素片溶出曲线一致性评价研究

摘要：目的 建立阿奇霉素片溶出曲线测定方法，评价国产仿制阿奇霉素片与原研药在4种不同pH的溶出介质中的体外溶出行为。方法 采用桨法，转速为75r/min，分别以pH2.0盐酸溶液、pH4.5磷酸盐缓冲液、pH6.0磷酸盐缓冲液和pH6.8磷酸盐缓冲液为溶出介质，溶出介质体积为900mL；采用UPLC法测定阿奇霉素溶出度，并计算累积溶出量，绘制溶出曲线；评价溶出曲线的相似度。结果 在4种不同pH的溶出介质中，国产和原研阿奇霉素片均在15min内溶出量达到了85%以上，说明两批国内仿制产品与原研药溶出行为基本一致，判定相似。结论 本方法适用于阿奇霉素片仿制药的溶出曲线测定，可为阿奇霉素片的质量一致性评价提供参考。

Consistency evaluation of dissolution curve of azithromycin tablets

Abstract Objective To establish a new method for the dissolution curve determination of azithromycinTablet, and evaluate the dissolution profiles of domestic generic tablets and the original tablets in four differentkinds of pH mediums. Methods The paddle method of dissolution determination method was adopted, therotation speed was 75 r/min, with the dissolution medium volume of 900 mL. UPLC was adopted to determine thecontent of azithromycin in pH 2.0 hydrochloride acid, pH 4.5 phosphoric acid, pH 6.0 phosphoric acid and pH 6.8phosphate buffer solution; the cumulative dissolution was calculated, the dissolution profiles were drawn, and thesimilarity of dissolution profiles were evaluated. Results In four different pH dissolution media, the dissolutionamount of domestic and original azithromycin tablets all reached more than 85% in 15 minutes, which indicatedthat the dissolution behaviors of two batches of domestic imitated products were basically the same with the originalazithromycin tablets, and the judgment was similar. Conclusion The method is suitable for the dissolution curvedetermination of azithromycin tablets, providing a reference for further quality consistency evaluation.