国产罗红霉素制剂质量分析

Quality analysis of the domestic roxithromycin preparation

目的对国内市场中的罗红霉素制剂(片剂、分散片、胶囊剂、颗粒剂及干混悬剂)进行全面地质量分析,评价其安全性、有效性和质量可控性。方法依据现行法定质量标准,对罗红霉素制剂进行标准检验,比较不同企业产品的质量现状,分析国内罗红霉素制剂质量的总体水平。针对不同现行标准的差异,结合文献调研,开展探索性研究,分别采用《中国药典》2020年版、EP10.8以及通过仿制药一致性评价企业标准所收载的方法对诸制剂进行比较分析。结果本次抽样涉及的79家罗红霉素制剂生产企业337批次样品,涉及全国31个省市自治区,涉及生产企业79家,其中抽到罗红霉素片61批次、分散片83批次、胶囊149批次、颗粒剂32批次和干混悬剂12批次,按法定标准检验,均符合规定,合格率为100.0%。与参比制剂溶出行为相比较,制剂的溶出度较上次国家药品抽检质量有了明显提升。结论罗红霉素制剂现行质量标准可行,质量状况较好。

Objective A comprehensive quality analysis and evaluation of roxithromycin preparations(tablets,dispersed tablets,capsules,granules and dry suspensions)listed in China were conducted in the present study from the perspectives of effectiveness,rationality and quality control.Methods Based on the current statutory quality standards,the roxithromycin preparation was subjected to standard inspection to analyze the overall level of the quality of roxithromycin tablets in China,to compare the quality of products in different enterprises,and to carry out exploratory studies,which are analyzed using the Chinese Pharmacopoeia version 2020,ep10.8,and the roxithromycin method as received by the corporate standard for consistency assessment of generic drugs.Results This sampling involved 337 batches of samples from 79 manufacturing enterprises for roxithromycin preparation,which involved 31 provinces,municipalities and autonomous regions throughout the country.Of these,61 batches of roxithromycin tablets,83 batches of dispersive tablets,149 batches of capsules,32 batches of granules and 12 batches of dry suspension were drawn and examined according to legal standards,all of which were found to be in compliance with the regulations with a pass rate of 100.0%.Compared with the dissolution behavior of the reference formulation,the dissolution rate of the formulation had significantly improved compared to the last national drug sampling quality.Conclusion The current quality standard of roxithromycin preparation was feasible and the quality status was good.