胰岛素及其制剂效价的HPLC测定法

DETERMINATION OF INSUI IN POTENCY BY HPLC

报道了一种用离子交换高效液相层析测定胰岛素效价的方法,适用于胰岛素结晶和多种胰岛素注射液,层析用含7mol/L 脲的20mmol/L Tris-HCl pH7.8缓冲溶液作流动相,以0～0.2mol/L NaCl 线性梯度洗脱。普通胰岛素注射液加 Tris 液调 pH 到中性,单峰纯长效胰岛素注射液加入肝素钠使之澄清后再进行测定,并将测定结果与传统的生物测定法进行了比较。

An ion exchange high-performance liquid chromatography methodfor determination of insulin potency is presented.It is applicable to both insulincrystal and its preparations.The method used was gradient elution with NaCl inTris-HCl buffer contaming 7mol/L urea.Insulin injection was treated by additionof Tris.Protamin zinc insulin injection was clarified by addition of heparin.Itwas verified to be simple and rapid by comparison with the traditional biologicalassay.