国家评价性抽验盐酸莫西沙星氯化钠注射液的细菌内毒素和异常毒性质量控制研究  

Quality control study on bacterial endotoxins and abnormal toxicity of moxifloxacin hydrochloride and sodium chloride injection for national evaluation sampling

作　　者：肖斯婷 李雪梅 管博 李彧 曹春然 XIAO Siting;LI Xuemei;GUAN Bo;LI Yu;CAO Chunran(Beijing Institute for drug control,Key Laboratory for safety research and evaluation of innovative drugs,State Drug Administration,Beijing Key Laboratory for analysis and biological evaluation of traditional Chinese medicine,Beijing 102206,China)

机构地区：[1]北京市药品检验研究院,国家药品监督管理局创新药物安全研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《中国药品标准》2024年第3期277-281,共5页Drug Standards of China

摘　　要：目的:对盐酸莫西沙星氯化钠注射液的安全性质量控制现状进行评价和研究。方法:对全国生产盐酸莫西沙星氯化钠注射液的15家生产企业进行抽样,依据其各自使用的标准进行检验,同时对涉及安全性的“细菌内毒素”和“异常毒性”项目进行拓展研究。分析其标准制定的合理性。结果:187批次的盐酸莫西沙星的依标检验,合格率为100%。但比较各企业使用的质量标准发现,其对细菌内毒素项目和异常毒性项目的要求存在较大差异。采用统一的更严格标准进行拓展检验后,187批次样品仍然全部合格。结论:盐酸莫西沙星注射液在安全性检查方面总体质量较好,建议将其安全性标准按国家药典委员会公示稿“盐酸莫西沙星氯化钠注射液”质量标准进行统一。Objective:To evaluate and study the current status of safety and quality control of moxifloxacin hydrochloride and sodium chloride injection.Methods:Fifteen production enterprises nationwide producing moxifloxacin hydrochloride and sodium chloride injection were sampled and tested according to each manufacturer′s respective quality standards.Additionally,the safety-related items of“bacterial endotoxins”and“abnormal toxicity”were further studied and expanded upon.The rationality of the existing standards was analyzed.Results:According to the standard test,the qualification rate of 187 batches of moxifloxacin hydrochloride was 100%.However,comparing the quality standards used by various enterprises,it was found that there are significant differences in their requirements for bacterial endotoxin projects and abnormal toxicity projects.After using a unified and stricter standard for expansion testing,all 187 batches of samples still passed.Conclusion:The overall quality of moxifloxacin hydrochloride and sodium chloride injection in China is satisfactory in terms of safety control.It is recommended to unify the safety standards according to the draft quality standard for“moxifloxacin hydrochloride and sodium chloride injection”issued by the National Pharmacopoeia Commission.

关 键 词：盐酸莫西沙星氯化钠注射液 评价性抽验 细菌内毒素 异常毒性 质量分析 

分 类 号：R921.2[医药卫生—药学]