高效液相色谱法测定胰岛素及其制剂中胰岛素的效价  

Determination of the insulin potency in insulin and its preparations by HPLC

作　　者：胡文晶[1] 金卫红[2] 

机构地区：[1]中国药科大学药学院,江苏南京210046 [2]江苏省药品检验所,江苏南京210008

出　　处：《中国生化药物杂志》2007年第5期340-341,共2页Chinese Journal of Biochemical Pharmaceutics

摘　　要：目的建立用高效液相色谱法测定胰岛素及其制剂的效价，并将之与已有的小鼠血糖法比较。方法色谱柱：C18柱（岛津VP-ODS，4．6mm×150mm，5μm）；流动相：0．2mol／L硫酸盐缓冲液（用乙醇胺调pH至2．3）-乙腈（73：27）；检测波长：214nm；流速：1mL／min。结果胰岛素在10～50u／mL范围内线性关系良好，回归方程为：Y=0．0014X＋0．2227，r=0．9998；精密度、重现性良好。结论此法灵敏度高、专属性强、准确、可靠，较生物测定法方便，适于胰岛素及其制剂中胰岛素的效价测定。Purpose To develop a HPLC method for the determination of insulin potency and to compare it with the method to assay the potency based on the glucose content in mice＇s blood. Methods The separation was performed on a VP-ODS column（4.6 mm ×150mm,5μm）.The mobile phase, was composed of 0.2 mol/ L sodium sulfate（pH was adjusted to 2.3 with ethanolamine）-acetonitrile （73：27） with flow rate 1 mL/min, detected at 214 nm. Results The calibration curve was linear in the range of 10-50 u/mL. The regression equation of insulin was Y = 0.001 4 X ＋ 0. 222 7, r = 0. 999 8 （ n = 5）. Conclusion The HPLC method was simple, sensitive and reliable for the determination of insulin.

关 键 词：胰岛素 高效液相色谱法 小鼠血糖法 效价测定 

分 类 号：R927.1[医药卫生—药学]