生物提取胰岛素中高分子蛋白杂质去除工艺的优化

Optimization of Removal Technology of Macromolecule Protein Impurity from Biological Insulin Extraction

对猪胰脏来源的胰岛素原料药中的高分子蛋白质杂质采用超滤膜和微孔滤膜过滤方法去除并对工艺进行了优化.通过去除后的原料药活性、收率、高分子蛋白质杂质去除率等参数并与标准品的比对.确定了高分子蛋白质杂质去除最佳条件.结果表明,经50kD超滤膜过滤方法能有效去除生物提取胰岛素原料药中高分子蛋白质杂质,并且收率较高,生物活性损失较低,可用于猪胰脏来源生物提取胰岛素的生产.

Both ultrafiltration and microporous membrane filtration were used to remove high molecular protein impurities in insulin crude drug from porcine pancreas,and the process condition was optimized.The optimal conditions of removing macromolecular protein impurities were determined by comparing the activity of crude drug,yield of crude drug,and removal rate of macromolecular protein impurities with those of standard samples.The results showed that the 50 kD ultrafiltration membrane filtration could effectively remove the high molecular protein impurities in crude drug during the process of biological extraction of insulin.It displays the high yield and low loss of biological activity,which could be used for the production of insulin from porcine pancreas.