大规模生产静脉注射用人血免疫球蛋白工艺的研究

本文介绍一种制备静脉注射用人血免疫球蛋白(IVIG)的工艺。工艺流程为:以低温乙醇法的 FⅢ上清为原料,经 NMWL 为3万的超滤膜脱醇,DEAE-Sephadex-A-50吸附,pH3.8～4.0条件下超滤,最后添加麦芽糖等稳定剂冻干。本工艺具有收率高、质量好、生产过程简单温和、经济效益显著等特点,适于大规模生产。

Studies on Manufacturing Technique of Human Plasma Immunoglobulin for Intravenous

In this article a process of manufacturing IVIG of integrate molecule was introduced.The Cohn's fraction Ⅲ(F Ⅲ)supernatant was used as raw material.Ethanol in FⅢ was removed by ultrafiltration using UF membrane of 30000 NMWL.Everyst- ep the pH was controlled.In order to improve IgG purity,the contaminated proteins was adsorbed with DEAE-Sephadex A-50.During ultrafiltration and diafiltration,pH was kept from 3.8 to 4.0 so as to prevent from polymer forming and ACA increasing, then stablizers(maltose and other substances were added following further sterilefiltr- ation and lyophilization.The IVIG produced by this processisof high recovery,good qual- ity and stability.This process is simple,mild,and economical.It's one of the ideal pr- ocess for IVIG preparation in large scale.