注射用头孢美唑钠的质量分析  

Quality analysis of cefmetazole sodium for injection

作　　者：耿悦 刘文欣 宋芸峰 庞庆林 张锦琳 侯玉荣 袁耀佐 曹玲 张玫 Geng Yue;Liu Wenxin;Song Yunfeng;Pang Qinglin;Zhang Jinlin;Hou Yurong;Yuan Yaozuo;Cao Ling;Zhang Mei(Jiangsu Institute of Food and Drug Control,Nanjing 210019;NMPA Key Laboratory for Impurity Profile of Chemical Drugs,Nanjing 210019;Nanjing University of Traditional Chinese Medicine,Nanjing 210029)

机构地区：[1]江苏省食品药品监督检验研究院,南京210019 [2]国家药品监督管理局化学药物杂质谱研究重点实验室,南京210019 [3]南京中医药大学,南京210029

出　　处：《中国抗生素杂志》2023年第8期912-920,共9页Chinese Journal of Antibiotics

基　　金：2021年国家药品评价性抽验资助国药监药管(No.[2021]1号)。

摘　　要：目的评价注射用头孢美唑钠的质量现状。方法采用调研、文献检索、法定标准检验结合探索性研究的方式,对国内20家企业生产的177批次的注射用头孢美唑钠及1批原研制剂的质量进行比较分析;通过对杂质谱、成盐率、配伍稳定性、包材相容性、无菌保障水平等关键质量属性进行考察,分析不同企业产品的质量差异。结果通过法定标准检验,177批次注射用头孢美唑钠均符合规定,但仍然存在部分项目检验方法和限度不统一,个别药品说明书不完善等问题。探索性研究中,采用LC/MS对杂质结构进行推断,对其来源进行归属。优化了有关物质检查方法。配伍稳定性结果表明,个别说明书需要修订。在无菌保障水平方面,国内企业在微生物的鉴定溯源能力方面还有待进一步加强。结论注射用头孢美唑钠符合现行标准要求,现行标准有待统一和提高。Objective To evaluate the quality status of cefmetazole sodium for injection.Methods 177 batches of cefmetazole sodium for injection produced by 20 enterprises and one batch of the original drug were compared and analyzed by means of investigation,literature search,the legal standard test,and exploratory research.By investigating the key quality attributes such as impurity spectrum,salt formation rate,packaging material compatibility,and sterility guarantee level,the quality differences of products from different enterprises were analyzed.Results Statutory tests showed that 177 batches of cefmetazole sodium for injection all met the requirements.But there were still some problems,such as inconsistent inspection methods and limits of some items,imperfect individual drug instructions,and so on.Through exploratory research,the impurity structures were inferred by LC/MS and their sources were attributed.The inspection methods of relevant substances were optimized.Compatibility stability results indicated that individual instructions needed to be revised.In terms of sterility assurance level,the identification and traceability ability of domestic enterprises needed to be further strengthened. Conclusion The overall quality of cefmetazole sodium for injection met the requirement of the current statutory standards, but the current standard needed to be unified and improved.

关 键 词：注射用头孢美唑钠 评价性抽验 质量分析 杂质谱 成盐率 配伍稳定性 包材相容性 无菌保障水平 

分 类 号：R978.1[医药卫生—药品]