混合重组人胰岛素注射液在模拟临床使用过程中的稳定性研究  

Stability of mixed recombinant human insulin injection in simulated clinical use

作　　者：孙雪[1] 黄元礼[1] 冯晓明[1] 卢大伟[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国新药杂志》2014年第23期2803-2805,2816,共4页Chinese Journal of New Drugs

基　　金：国家科技支撑计划(2012BAI22B01)

摘　　要：目的：选取已上市的国产及进口混合重组人胰岛素注射液，按照使用说明书对笔芯内重组人胰岛素进行完全模拟临床注射操作，至注射行程终点，对笔芯中胰岛素注射液的初始效价、中间效价、取样后笔芯中剩余药液效价（以下简称剩余效价），以及可溶性重组人胰岛素效价进行检测，评价其是否稳定和符合相关规定。方法：采用Phenomenex C18柱（250mm×4．6mm，5μm）；流动相为0．2mol·L^-1硫酸盐缓冲液-乙腈（73：27）；检测波长为214nm；流速1．0mL·min^-1；柱温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的注射液及剩余注射液液总效价均在产品标示量的90．0％-110．0％范围内，可溶性重组人胰岛素在总效价的27．0％～33．0％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，笔芯的效价未发生显著变化，稳定性良好。Objective： To evaluate the potency of the cartridges at the initial and mid-phase, and the endpoint remnant medicine of recombinant human insulin injections, both domestic and imported, according to the product instructions in a simulated clinical environment for analyzing their stability. Methods： Phenomenex C18 column （250 mm× 4.6 mm, 5μm） was used. The mobile phase was sulfate buffer （0.2 mol·L^-1）-acetonitrile （ 73 ： 27 ） , the flow rate was 1.0 mL·min^-1, and the detection wavelength was at 214 nm. Simulated clinical operation, the samples were tested at the specified time points. Results ： The potencies of all the samples at various time points were within 90.0% to 110.0% of the listed values, and 27.0% - 33.0% for the soluble recombinant human insulin injection （pre-mixed 30R）. RSD was within 2.0% （n = 6）. Conclusion： The potency of mixed recombinant human insulin injections does not show significant change, thus a desirable glycemic control can be expected if the product instructions are strictly followed during clinical applications.

关 键 词：混合重组人胰岛素 效价 临床使用 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]