国产琥乙红霉素颗粒质量分析

目的综合评价琥乙红霉素颗粒的质量现状。方法采用现行法定标准检验结合探索性研究结果,对市场上14家企业生产的191批琥乙红霉素颗粒的质量进行系统比较,通过对原料药和制剂组分、有关物质、游离红霉素等的考察,结合稳定性和原辅料相容性试验,分析不同企业产品的质量差异。结果法定标准检验191批琥乙红霉素颗粒,合格率为99.5%;探索性研究显示,法定标准中组分、有关物质及游离红霉素检查项的缺失,导致质量控制不到位。结论国内琥乙红霉素颗粒整体质量一般,现行质量标准有待提高。

Quality analysis of the domestic erythromycin ethylsuccinate granules

Objective To evaluate the quality status of erythromycin succinate granules. Methods According to the general requirements of national drug assessment programs, the statutory testing methods combined with the exploratory researches were used to research on the quality of 191 batches of erythromycin succinate granules from fourteen production enterprises systematically, based on the components of drug substances and drug products, the related substances, such as free erythromycin, combined with the stability and raw material compatibility test, and the analysis of the quality differences of different enterprise products. Results The statutory tests showed that the pass rate of the 191 batches of erythromycin succinate granules was 99.5%. Exploratory research revealed that the current standard components lacked the related substances and checking method of free erythromycin, leading to poor quality control. Conclusion The overall quality of the domestic erythromycin succinate granules were good, but the quality standard needs to be