摘要
目的选取该公司生产的与原研厂家的精蛋白锌重组赖脯胰岛素混合注射液(50R),按照万邦笔使用说明书对笔芯内精蛋白锌重组赖脯胰岛素混合注射液(50R)进行完全模拟临床注射操作,至注射行程终点,对其初始、中间、取样后笔芯中剩余药液的含量与可溶性重组赖脯胰岛素进行检测,评价其在临床使用中是否稳定和符合相关规定。方法采用Inertsil ODS-SP色谱柱(250 mm×4.6 mm,5μm);流动相为0.2 mol/L硫酸盐缓冲液-乙腈(74∶26);检测波长为214 nm;流速为0.8 mL/min;柱温为40℃。模拟临床注射操作,在指定时间点取样检测。结果全部样品各时间点取样与剩余药液的含量均在产品标示量的90.0%~105.0%范围内,可溶性重组赖脯胰岛素在45.0%~55.0%范围内,RSD(n=6)均在2.0%以内,符合相关规定。结论患者在临床使用中严格依据笔式注射器及笔芯使用说明书进行操作,精蛋白锌重组赖脯胰岛素混合注射液(50R)笔芯内重组赖脯胰岛素含量与可溶性重组赖脯胰岛素均未发生显著变化,稳定性良好。
Objective To evaluate whether it is steady and conforms to the related regulations in clinical use by selecting the mixed protamine zinc recombinant human insulin lispro injection(50R)produced by our company and conducting the totally simulation clinical injection operation to the final point of injection course,and testing the content of residual liquid in cartridge and soluble recombinant lyline insulin.Methods Inertsil ODS-SP chromatographic column(250 mm×4.6 mm,5μm);mobile phase 0.2 mol/L;sulfate buffers-acetonitrile(74:26);detection wavelength 214 nm;flow rate 0.8 mL/min;column temperate 40℃,and the clinical injection operation was stimulated and the samples were selected for test at the specific time point.Results The samples at various time points and content of residual liquid of all samples were in the 90.0%~105.0%,and the soluble recombinant lyline insulin was 45.0%~55.0%,and RSD(n=6)was in 2.0%,conforming to the related regulations.Conclusion The patients should conduct the operation strictly according to the pen injector and instructions,and there are no obvious changes of mixed protamine zinc recombinant human insulin lispro injection(50R),content of residual liquid in cartridge and soluble recombinant lyline insulin,and the stability is good.
作者
梅丽
栗凤娟
牛瑞娟
卓盼
王军军
MEI Li;LI Feng-juan;NIU Rui-juan;ZHUO Pan;WANG Jun-jun(Jiangsu Wanbang Pharmaceutical Technology Co,Ltd,Xuzhou,Jiangsu Province,221004 China)
出处
《糖尿病新世界》
2017年第24期24-26,共3页
Diabetes New World Magazine
关键词
精蛋白锌重组赖脯胰岛素混合注射液(50R)
万邦笔
含量
可溶性赖脯胰岛素
临床使用
高效液相色谱仪
Mixed protamine zinc recombinant human insulin lispro injection(50R)
Wanbang pen
Content
Soluble recombinant lyline insulin
Clinical use
High performance liquid chromatography
