目的　建立一种准确、快速、简便的方法测定胰岛素注射液的含量。方法　采用毛细管区带电泳法 (CZE)以pH 7.8,0 .0 5mol·L- 1 的磷酸盐缓冲液做运行液 ,进行胰岛素注射液中各组分的分离 ,工作电压 18kV(运行电流 130～ 140 μA) ,以波长2 14nm紫外检测装置进行检测 ,并以苯巴比妥作内标 ,测定胰岛素含量。结果　在此条件下 ,胰岛素注射液中各成分可以完全分离 ,保留时间为 4～ 8min ,胰岛素的平均出峰时间为 4.973min(RSD0 .6 6 % ,n =10 ) ,内标为 5 .6 2 1min(RSD0 .6 4% ,n =10 )。胰岛素浓度在 10～ 10 0u·ml- 1 范围内 ,浓度与胰岛素峰面积与内标峰面积比值之间呈良好的线性关系。平均回收率 98.95 %(RSD0 .97% ,n =6 ) ,3批样品日内测定 8次 ,RSD <1.5 % ,日间测定 3次RSD <1.0 % ,两批样品与HPLC测定值比较最大相差0 .5 2 %。结论　在本实验条件下应用CZE测定胰岛素注射液的含量可以收到满意的结果 ,与HPLC相比有相同的准确性 ,但更为快速、简便、节省溶剂。 Objective To establish an accurate, rapid and simple method for the determination of insulin injection. Methods The capillary zone electrophoresis (CZE) was used as the working solution in pH 7.8,0. 5mol·L-1 phosphate buffer to separate the components in the insulin injection. The working voltage was 18kV (operating current 130 ~ 140 μA) to detect the wavelength of 14nm UV detection device, and phenobarbital as an internal standard, determination of insulin content. Results Under these conditions, the components in insulin injection could be completely separated, the retention time was 4 ~ 8min, the average peak time of insulin was 4.973min (RSD0.66%, n = 10), and the internal standard was 5.6 2 1min (RSD0.64%, n = 10). Insulin concentration in the range of 10 ~ 10u · ml-1, the concentration and peak area of ​​insulin and internal standard peak area ratio showed a good linear relationship. The average recovery was 98.95% (RSD0.97%, n = 6). The three batches of samples were assayed 8 times in a day with RSD <1.5%. The RSDs were less than 1.0% .5 2%. Conclusions The CZE assay of insulin injections provides acceptable results with the same accuracy as HPLC, but is faster, easier and solvent safer.