层析法从血浆分离静注人免疫球蛋白及其初步检定

目的：实验尝试采用多步柱层析的工艺取代乙醇低温沉淀的方法，能高效的从血浆中获得IVIG产品。方法：通过亲和层析、离子交换一套工艺纯化出IVIG产品，进而按照枟中华人民共和国药典枠对静注人免疫球蛋白（pH4）及其关键指标进行了检测。在此基础上还采用免疫浊度法等方法，对其纯度和非目的蛋白构成与国际产品进行比较。结果：工艺获得IVIG产品的关键性指标检测均达到枟中华人民共和国药典枠的要求，其质量不低于现有国际同类产品。结论：本工艺能以较高回收率获得高质量的IVIG产品。

Primary characterization of preparation of IVIG separated by chromatography

Objective To manufacture high quality IVIG from pooled human plasma by a series of separation of chromatog -raphies instead of the conventional ethanol fractionation .Methods Separation by chromatography was used at the first step to replace the precipitation of IVIG with ethanol .Downstream process including caprylate precipitation and ion exchange were performed to obtain final bulk .The IVIG produced in this study was characterized according to Chinese Pharmacopoeia and compared with an IVIG product currently used in worldwide .Results IVIG obtained in this study passed all critical compendial testing .The impurity profile suggests that the obtained IVIG is at least as good as , if not better than , its coun-terpart on the world market .Conclusion Purification of high quality IVIG with a high recovery rate from human plasma is achieved by this novel chromatograph process .