静脉注射免疫球蛋白制剂分馏过程中病毒的灭活与清除：液体热处理及聚乙二醇分馏

Inactivation and elimination of viruses during the fractionation of an intravenous immunoglobulin preparation: liquid heat treatment and polyethylene glycol fractionation.

作者信息

Uemura Y, Uriyu K, Hirao Y, Takechi K, Ishikawa H, Nakajima T, Kagitani Y, Yokoyama K, Funakoshi S, Nishida M

机构信息

Department of Research and Development, Green Cross Corporation, Osaka, Japan.

出版信息

Vox Sang. 1989;56(3):155-61. doi: 10.1111/j.1423-0410.1989.tb02019.x.

DOI:10.1111/j.1423-0410.1989.tb02019.x

PMID:2499119

Abstract

A method for the heat treatment of human IgG solution at 60 degrees C for 10 h was established. Human immunodeficiency, mumps, vaccinia and 4 other viruses were added to the IgG solution in 33% sorbitol and heated at 60 degrees C. Those viruses were inactivated within 1 h. Heat-treated intravenous IgG (IVIG-H) was prepared by heat treatment and polyethylene glycol (PEG) fractionation. Conventional nonheated intravenous IgG (IVIG-C) was prepared from the same source paste by the fractionation method. No physicochemical or biological difference was observed between the heated and control IVIG preparations.

摘要

建立了一种在60℃下对人IgG溶液进行10小时热处理的方法。将人类免疫缺陷病毒、腮腺炎病毒、牛痘病毒和其他4种病毒添加到含有33%山梨醇的IgG溶液中，并在60℃下加热。这些病毒在1小时内被灭活。通过热处理和聚乙二醇（PEG）分级分离制备了热处理静脉注射免疫球蛋白（IVIG-H）。通过分级分离法从同一来源的糊剂中制备了常规的未加热静脉注射免疫球蛋白（IVIG-C）。在加热的和对照IVIG制剂之间未观察到物理化学或生物学差异。