摘要
目的:对2018年我省专项监督抽验诺氟沙星胶囊、盐酸环丙沙星片的有关物质进行考察,并对现行标准进行探讨。方法:按《中国药典》2015年版二部对2018年省抽样品进行有关物质检查,并对结果进行分析。结果:52批次样品的有关物质均符合规定。部分诺氟沙星胶囊样品主峰前有一杂质峰与主峰未完全分离,而现行标准未控制与该杂质峰的分离度。采用现行标准定位环丙沙星杂质E与采用中国食品药品检定研究院标准物质定位的保留时间不同。结论:按现行标准检验,本次省专项监督抽验诺氟沙星胶囊、盐酸环丙沙星片的有关物质情况良好。建议优化诺氟沙星胶囊和盐酸环丙沙星片的质量标准,以期更好的控制药物的质量。
Objective:To investigate the related substances of Norfloxacin Capsules and Ciprofloxacin Hydrochloride Tablets from special supervision sampling in our province in 2018,and to discuss the current standard.Methods:According to ChP2015 editionⅡ,the related substances in the samples of the province in 2018 were examined and the results were analyzed.Results:52 batches of related substances met the requirements.There was an impurity peak in front of the main peak of some Norfloxacin Capsules,which was not completely separated from the main peak.However,the current standard did not control the separation with this impurity peak.The retention time of ciprofloxacin impurity E positioned by the current standard is different from that of the standard substance.Conclusion:According to the current standard test,the related substances of Norfloxacin Capsules and Ciprofloxacin Hydrochloride Tablets from special supervision sampling in 2018 are in good condition.In order to control the quality of drugs better,it is suggested to optimize the quality standards of Norfloxacin Capsules and Ciprofloxacin Hydrochloride Tablets.
作者
姚永青
宋汉敏
刘英
YAO Yongqing;SONG Hanmin;LIU Ying(Henan Provincial Institute of Food and Drug Control,Henan,Zhengzhou 450018,China)
出处
《中国药品标准》
CAS
2020年第4期329-334,共6页
Drug Standards of China
关键词
有关物质
诺氟沙星胶囊
盐酸环丙沙星片
质量标准
related substances
norfloxacin capsules
ciprofloxacin hydrochloride tablets
quality standard
