国产罗红霉素片质量分析

目的通过对上市罗红霉素片的检验与研究,从有效性、合理性和质量可控性等方面对其进行全面质量分析评价。方法依据现行法定质量标准,对全国范围内的罗红霉素片进行标准检验,运用多种统计学方法,分析国内罗红霉素片质量的总体水平,比较不同企业产品质量。根据专题调研、文献检索和标准检验结果分析等情况,开展了有关物质、溶出曲线和晶型研究。分别采用中国药典(ChP)2015和英国药典(BP)2016所收载的罗红霉素有关物质分析方法,对罗红霉素有关物质进行测定。结果本次抽验涉及的21个生产企业的327批罗红霉素片按法定标准检验,有326批次符合规定,合格率为99.7%。结果显示ChP2015和BP2016液相色谱行为有一定差别,两种方法测定的罗红霉素最大杂质和总杂质含量相当。对罗红霉素片溶出曲线的研究时发现大部分国内产品与原研产品差别较大。晶型考察结果证明罗红霉素存在3种晶型。结论罗红霉素片现行质量标准可行,质量状况较好。

Quality analysis of domestic roxithromycin tablets

Objective Based on the tests and the research of roxithromycin tablets, we analyzed and evaluated the quality of roxithromycin tablets in the respect of effectiveness, reasonableness, and quality controllability. Methods The nationwide roxithromycin tablets were tested according to the official quality standards. The quality was analyzed by using multiple statistical methods. The products from different manufacturing enterprises were compared. We performed an exploratory research on related substances, resolution curves, and crystal forms of roxithromycin. Methods in Chinese Pharmacopoeia 2015 (ChP 2015) and British Pharmacopoeia 2016 (BP 2016) were used for detecting related substances of roxithromycin tablets. There were some differences between the HPLC behaviors according to ChP 2015 and BP 2016. Results 327 batches of samples from 21 manufacturing enterprises were tested; 326 batches were in compliance with the regulations, and the pass rate was 99.7%. The contents of the main impurity and the total impurities determined by the two methods were equivalent. A great difference was detected when doing the resolution curve research. Three crystal forms were found in the research. Conclusion The official quality standards of roxithromycin tablets are effective to control the quality. Therefore, the quality was satisfactory in