单组分胰岛素的研制

The preparation of monocomponent insulin

目的 采用新型离子交换膜制备单组分胰岛素。方法 以单峰胰岛素为原料 ,用离子交换膜为层析材料快速制备单组分胰岛素 ,通过电泳、HPLC对产品进行纯度分析。结果 制得的单组分胰岛素回收率为 72 .37%± 0 .82 % (n =3) ,放大实验为 74 .16 %± 0 .91% (n =3)。制得的产品电泳检测为单带 ,HPLC检测脱酰胺胰岛素含量为 1.10 %± 0 .31% (n =9) ,符合美国药典第 2 4版标准。

OBJECTIVE To prepare monocomponent insulin on a novel ion exchange membrane . METHODS To use anion exchange membrane as the separation material to purify single peak insulin to monocomponent insulin. Using the electrophoresis and HPLC methods to analyze the purity of the products. RESULTS The recoveries of monocomponent insulin were 72.37%±0.82% ( n =3) and the results of enlarged experiments were 74.16%±0.91% ( n =3).The complete procedure consumed only a short spell.The product showed single band on electrophoresis analysis. The contents of monodesamido-insulin determined by HPLC were 1.10%±0.31%( n =9),conforming to the relative standard of USP(24 edition). CONCLUSION This technology could produce monocomponent insulin rapidly.