克拉霉素片体外溶出曲线比较研究

Comparative study on dissolution curves of clarithromycin tablets in vitro

目的建立克拉霉素片的溶出曲线比较法,比较7家国产制剂与参考制剂在不同溶出介质中的溶出曲线。方法采用桨法,转速为50r/min,分别用pH6.0、pH6.8、pH7.0缓冲液为溶出介质,参考2015年版《中国药典》克拉霉素含量测定项下的色谱条件和系统适用性,测定累计溶出率,采用单点判定法和相似因子法比较7家国产制剂与参考制剂溶出曲线的相似性。结果 2家国产制剂在pH6.0缓冲液中的溶出曲线与参考制剂相似,1家国产制剂在pH6.8缓冲液中的溶出曲线与参考制剂相似,3家国产制剂在pH7.0缓冲液中的溶出曲线与参考制剂相似。结论采用pH6.0、pH6.8、pH7.0缓冲液作为溶出介质,可有效区分不同工艺的克拉霉素片;国产制剂与参考制剂的溶出曲线在上述溶出介质中存在一定差异。

Objective To establish the method of dissolution curves of clarithromycin tablets and compare the dissolution curves among seven domestic products and reference products. Methods The paddle method was adopted with rotational speed of 50r/min, using phosphate buffer of pH6.0, pH6.8 and pH7.0, respectively. Taking the chromatographic condition and system suitability of elarithromycin in ChP 2015 Edition to determine the cumulative dissolution, then the single-point method and the similarity factor method were used to evaluate the similarity between domestic products and reference products. Results There are two, one and three domestic products had consistent dissolution curves with reference products in phosphate buffer of pH6.0, pH6.8 and pH7.0, respectively. Conclusion The dissolution method has discriminatory power for the prescription process of clarithromycin tablets when using phosphate buffer of pH6.0, pH6.8 and pH7.0 as the dissolutive media. There are some differences of the dissolution curves between domestic products and the reference tablets.