摘要
目的评价国内上市的注射用头孢尼西钠整体的质量状况。方法按照国家评价抽验计划要求,分别采用法定检验和探索性研究对样品进行了检验,统计分析数据并评价注射用头孢尼西钠的整体质量水平。结果按法定标准检验80批次样品,合格率100%。但个别产品在溶液状态会出现降解产物——头孢尼西内酯析出的现象;现有标准中的有关物质检测方法无法检出全部杂质;个别企业原料中发现微量的异亚丙基丙酮(QSAR评估——含有与原料药结构无关的警示结构,无致突变性数据);标准中未控制成盐剂2-乙基己酸的残留量。结论本次评价性抽验结果显示,国内上市的注射用头孢尼西钠总体质量一般;现行标准有待提高,建议修订有关物质项,增加异亚丙基丙酮的控制;样品溶液放置过程中存在的头孢尼西内酯析出情况,可能增加临床使用风险,建议关注。
Objective To evaluate the quality condition of cefonicid sodium for injection of domestic.Methods According to the general requirements of national drug assessment programs,using the statutory testing methods and the exploratory researches to examine samples,Statistics and analysis data,evaluate the overall qualitystatus of cefonicid sodium for injection.Results According to the statutory testing of 80 bathes,the qualified rate of samples was 100%.However,degradation appeared in the solution state of some products,which was cephalosporin.In addition,the method of related substances could not accurately detect impurities.Trace amount of isopropylidene acetone was found in one of API enterprise(QSAR assessment showed that there were warning structures unrelated to the structure of API,and no mutagenicity data were found).The salt forming agent of 2-ethylhexanoic acid was not controlled in the standard.Conclusion According to the result,the overall quality of domestic products is average.The statutory standards need to be improved,revision of the related substances item and addition of the isopropylidene acetone item are suggested.The precipitation of cephalosporin in the sample solution during storage will increase the risk of clinical use,which needs to arouse attention.
作者
李雪
李佩
丁子珊
洪建文
Li Xue;Li Pei;Ding Zi-shan;Hong Jian-wen(Guangdong Institute for Drug Control,Guangzhou 510663)
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2021年第3期210-215,共6页
Chinese Journal of Antibiotics
