摘要
目的评价甘精胰岛素注射液的质量现状及存在问题,对现行质量标准的科学性及合理性进行评估,为其安全评价及安全监管提供参考。方法对甘精胰岛素注射液进行国家评价性抽检,采用法定标准方法对抽检样品的有关物质及含量测定项目进行检验,并对不同企业的样品进行了稳定性研究及样品使用期有关物质增长情况研究,采用LC-MS方法对含量较高的有关物质进行了结构确认,根据研究结果对企业标准及《中华人民共和国药典》(2020年版)各论中有关物质的限度规定进行了科学性及合理性评估。结果按照法定标准检验,48批次的甘精胰岛素注射液样品有关物质及含量测定结果均合格,合格率100%。稳定性研究发现,部分企业样品有关物质的数量及含量结果偏高;样品使用期有关物质增长情况研究发现,部分企业样品中最大有关物质的含量有超出企业质量标准限度规定的风险。结论甘精胰岛素注射液总体质量较好。建议企业考察产品在货架期及使用期(尤其是近效期产品)的有关物质的增长情况,并参考《中华人民共和国药典》(2020年版)甘精胰岛素注射液各论,科学合理地制定标准限度规定。
Objective To evaluate the quality of and problems with insulin glargine injections,and study the validity and rationality of drug specifications so as to provide reference for evaluation and supervision of safety.Methods Insulin glargine injections were sampled and evaluated nationwide.The related substances and contents of the samples were tested using the stipulated standard method.The stability of injections and the increase of related substances of injections in usewere tested via exploratory research,and the structures of main related substances were confirmed by LC-MS/MS.According to the results,the limits of related substances specified in enterprise standards and the current Chinese pharmacopoeia standard were evaluated.Results The qualified rate of 48 batches of insulin glargine injections was 100%.Exploratory research showed that the number or contents of related substances in some of the insulin glargine injections were higher,and the contents of maximum related substances in some of the injections were at risk of exceeding the limit of enterprise standards.Conclusion The overall quality of insulin glargine injections is good.Related enterprises should formulate rational and precise limits of related substances in line with the Chinese pharmacopoeia by investigating the increase of relevant substances on the shelf or in use(especially near-effect products).
作者
丁晓丽
胡馨月
王雪蕾
孙悦
李晶
张慧
梁成罡
王岩
DING Xiaoli;HU Xinyue;WANG Xuelei;SUN Yue;LI Jing;ZHANG Hui;Liang Chenggang;WANG Yan(NationalInstitutes for Food and Drug Control,Institute for Chemical Drug Control,NMPA Key Laboratory for Quality Research and Evaluation ofChemical Drugs,Beijing 102629,China)
出处
《中国药物警戒》
2024年第6期644-650,共7页
Chinese Journal of Pharmacovigilance
基金
国家重点研发计划(2021YFF0600804)。
关键词
甘精胰岛素
注射液
评价性抽检
质量评价
有关物质
药品使用期
稳定性研究
质量标准
标准限度
insulin glargine
injection
sampling inspection
quality evaluation
related substance
in-use period
stability study
standard
limit of related substances
