具有区分力的罗红霉素片体外溶出度方法研究

Discriminatory dissolution method development of roxithromycin tablets

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p H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p H6.8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p H 6.8磷酸盐缓冲液中的溶出曲线不相似。结论以p H 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 p H solutions were measured, the dissolution curves of two self-prepared preparations and reference preparation in four different p H dissolution media were determined, and the similarity was investigated according to the f2 factor method. Results Roxithromycin has a good stability in p H6.8 and p H7.4 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 p H6.8 phosphate buffer solution. Conclusion The discriminatory dissolution method was established using paddle method, 75 r/min rotation speed, and 900 m L p H6.8 phosphate buffer solution,the method can be used as a quality control test and consistency evaluation.