目的 研究罗红霉素片的溶出行为，确定有区分力的溶出度检查方法。方法 考察罗红霉素在不同pH溶液中的稳定性及溶解度，测定不同处方自研制剂与参比制剂在4种不同溶出介质中的溶出度，绘制溶出曲线，用相似因子法进行拟合。结果 罗红霉素在pH6.8和7.4磷酸盐缓冲液中8 h内稳定性较好，自研制剂A与参比制剂在4种溶出介质中的溶出曲线均具有较好的相似性，自研制剂B与参比制剂在pH 6.8磷酸盐缓冲液中的溶出曲线不相似。结论 以pH 6.8磷酸盐缓冲液为溶出介质，采用浆法测定，75 r/min对本品溶出具有较好的区分力，可为本品的质量控制和一致性评价提供参考。

Objective To study the dissolution curves of Roxithromycin Tablets and determine the discriminatory method of dissolution test. Methods The stability and solubility of Roxithromycin in different pH solutions were measured, the dissolution curves of two self-prepared preparations and reference preparation in four different pH dissolution media were determined, and the similarity was investigated according to the f₂ factor method. Results Roxithromycin has a good stability in pH6.8 and pH7.4 phosphate buffer solution within 8 hours. The dissolution curves were similar between self-prepared Roxithromycin Tablet A and reference preparation in four different media, the dissolution curves were not similar between self-prepared Roxithromycin Tablet B and reference preparation in pH6.8 phosphate buffer solution. Conclusion The discriminatory dissolution method was established using paddle method, 75 r/min rotation speed, and 900 mL pH6.8 phosphate buffer solution,the method can be used as a quality control test and consistency evaluation.