对甘精胰岛素有关物质分析用系统适用性试验的研究  

Study on System Suitability Test for Determination of Related Substances of Insulin Glargine

作　　者：丁晓丽[1] 胡馨月 孙悦[1] 李晶[1] 张慧[1] 王岩[1] 梁成罡[1] Ding Xiaoli;Hu Xinyue;Sun Yue;Li Jing;Zhang Hui;Wang Yan;Liang Chenggang(National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,国家药品监督管理局化学药品质量研究与评价重点实验室,北京102629

出　　处：《中国药事》2024年第2期175-183,共9页Chinese Pharmaceutical Affairs

基　　金：国家重点研发计划课题“蛋白类生物制品主成分及其相关成分精准定量检测技术研究”(编号2021YFF0600804)。

摘　　要：目的:对不同企业甘精胰岛素有关物质分析用系统适用性试验进行研究,发现存在的问题,提示企业完善质量标准,更科学有效地控制产品质量。方法:采用高效液相色谱法及液质联用方法对不同企业有关物质分析用系统适用性试验进行研究评价,发现存在多种问题。结果:部分企业系统适用性溶液中所用的“0A-甘精胰岛素”的结构经LC-MS/MS确认后,发现与理论序列不同,部分企业采用酶切方法制备系统适用性溶液,存在杂质较多、操作步骤复杂、溶液易浑浊等问题。结论:建议企业提高对系统适用性试验的重视程度,加强研究,完善质量标准,科学有效地进行药品质量控制。Objective:To study on system suitability test for determination of related substances of insulin glargine in diff erent enterprises,and identify existing problems,so as to prompt enterprises to improve quality standards and control product quality more scientifi cally and eff ectively.Methods:The system suitability test for determination of related substances of insulin glargine in diff erent enterprises was studied by HPLC and LC-MS/MS,and multiple problems were found.Results:The structures of"0A-insulin glargine"confi rmed by LC-MS/MS were diff erent from the theoretical sequence in some enterprises.There are many problems of system suitable solution prepared by enzyme digestion in some other enterprises,such as more impurities,complex operation steps,turbidity of the solution and so on.Conclusion:It is suggested that the enterprises should pay more attention to the system suitability test,strengthen the research and improve the quality standards,so as to carry out the drug quality control scientifi cally and eff ectively.

关 键 词：甘精胰岛素 有关物质 系统适用性试验 高效液相色谱法 液质联用技术 0A-甘精胰岛素 结构确认 

分 类 号：R917[医药卫生—药物分析学]