目的 研究羅紅霉素片的溶出行為，確定有區(qū)分力的溶出度檢查方法。方法 考察羅紅霉素在不同pH溶液中的穩(wěn)定性及溶解度，測定不同處方自研制劑與參比制劑在4種不同溶出介質中的溶出度，繪制溶出曲線，用相似因子法進行擬合。結果 羅紅霉素在pH6.8和7.4磷酸鹽緩沖液中8 h內穩(wěn)定性較好，自研制劑A與參比制劑在4種溶出介質中的溶出曲線均具有較好的相似性，自研制劑B與參比制劑在pH 6.8磷酸鹽緩沖液中的溶出曲線不相似。結論 以pH 6.8磷酸鹽緩沖液為溶出介質，采用漿法測定，75 r/min對本品溶出具有較好的區(qū)分力，可為本品的質量控制和一致性評價提供參考。

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.