盐酸环丙沙星片质量分析  

Quality analysis of ciprofloxacin hydrochloride tablets

作　　者：何劼毅 聂鹏 田甜[1] 漆欣筑 HE Jie-yi;NIE Peng;TIAN Tian(Guizhou Institute for Food and Drug Control,Guiyang 550004,China)

机构地区：[1]贵州省食品药品检验所,贵阳550004

出　　处：《中国处方药》2022年第10期14-18,共5页Journal of China Prescription Drug

基　　金：贵州省科技计划项目(黔科合基础-ZK[2021]一般041)。

摘　　要：目的对2020年国家评价性抽验中的123批次盐酸环丙沙星片的质量进行考察分析,评价本品的质量现状,并分析存在的问题。方法采用法定方法检验该品种,并开展有关物质、溶出度、破坏性探索实验,统计分析盐酸环丙沙星片的质量现状并进行评价。结果经法定方法检验,123批样品合格率为100%,经探索性研究,有关物质项结果符合拟定标准要求,破坏性试验结果不影响该品种整体质量。结论本次国家评价性抽验中的123批次盐酸环丙沙星片质量较好。各厂家的产品质量有差异,应提高质量和工艺稳定性。Objective To evaluate the current quality situation and problems of ciprofloxacin hydrochloride tablets by testing and analyzing 123 batches of ciprofloxacin hydrochloride tablets in National Assessment Programs.Methods The statutory testing methods were used to test the samples,and the quality status was evaluated by statistical analysis of ciprofloxacin hydrochloride tablets.Results According to the statutory tests the qualified rate of 123 batches of samples was 100%.According to the exploratory studies the results of the related substances met the requirement of the improved standard draft.The overall quality is not affected by the results of destructive tests.Conclusion At present the overall quality of ciprofloxacin hydrochloride tablets is good,the product quality of different manufacturers is variant,and it is necessary to improve the preparation process stability and the quality.

关 键 词：盐酸环丙沙星 探索性实验 质量分析 

分 类 号：R927.1[医药卫生—药学]