722件进口精蛋白锌重组赖脯胰岛素混合注射液质量研究  

Quality analysis of 722 imported mixed protamine zinc recombinant human insulin lisproinjection

作　　者：张国林 王思渊 田沛霖 鲁辉 李玥琦 徐铠琳 戴国英 张斌 周忆新 邢以文 薛满 ZHANG Guo-lin;WANG Si-yuan;TIAN Pei-lin;LU Hui;LI Yue-qi;XU Kai-lin;DAI Guo-ying;ZHANG Bin;ZHOU Yi-xin;XING Yi-wen;XUE Man(Suzhou Institute for Drug Control,Suzhou 215000,China)

机构地区：[1]苏州市药品检验检测研究中心,苏州215000

出　　处：《药物分析杂志》2021年第11期2039-2048,共10页Chinese Journal of Pharmaceutical Analysis

基　　金：苏州市科技发展项目(SYS2020199)。

摘　　要：目的:对进口精蛋白锌重组赖脯胰岛素混合注射液进行质量分析。方法:对2018~2020年经苏州口岸进口的129批(722件)精蛋白锌重组赖脯胰岛素混合注射液的有关物质、苯酚和间甲酚、可溶性赖脯胰岛素、含量、锌、高分子蛋白质、pH等质量参数进行统计分析,并对结果进行趋势分析。结果:精蛋白锌重组赖脯胰岛素混合注射液(25R)36批352件,占48.8%,精蛋白锌重组赖脯胰岛素混合注射液(50R)93批370件,占51.2%。722件精蛋白锌重组赖脯胰岛素混合注射液关键参数检测结果主要位于平均值±2SD区间。苯酚和间甲酚、可溶性赖脯胰岛素、含量、锌、pH等均未超过平均值±3SD,但部分批次产品的有关物质和高分子蛋白质超过平均值±3SD。结论:精蛋白锌重组赖脯胰岛素混合注射液总体情况稳定,质量较好。Objective:To analyze the quality of imported mixed protamine zinc recombinant insulin lispro injection.Methods:The related substances,phenol and m-cresol,soluble insulin lispro,content,zinc,high molecular protein,pH value and other quality parameters of 129 batches(722 pieces)of mixed protamine zinc recombinant insulin lispro injection imported through Suzhou port from 2018 to 2020 were statistically analyzed.Results:There were 352 pieces of protamine zinc recombinant insulin lispro mixed injection(25 R)in 36 batches,accounting for 48.8%.There were 370 pieces of spermine zinc recombinant insulin lispro mixed injection(50 R)in 93 batches,accounting for 51.2%.The key parameters of 722 pieces of protamine zinc recombinant insulin lispro mixedinjection were mainly in the range of±2 SD.Phenol,m-cresol,soluble insulin lispro,content,zinc,pH value were not more than the average value±3 SD,but the related substances and high molecular protein of some batches of products exceeded the average±3 SD.Conclusion:Generally speaking,the quality of mixed protamine zinc recombinant insulin lispro injection was stable and good.

关 键 词：胰岛素 质量回顾 趋势分析 警戒限 纠偏限 

分 类 号：R917[医药卫生—药物分析学]