人血浆来源治疗性产品中病毒的灭活
Inactivation of viruses in therapeutic products derived from human plasma.
作者信息
Mitra G, Dobkin M B, Louie R E, Mozen M M
机构信息
Cutter Biological of Miles Inc., Berkeley, California 94701.
出版信息
Am J Med. 1988 Jun 24;84(6A):87-90. doi: 10.1016/0002-9343(88)90164-7.
PMID:2837900
Abstract
Alpha-1-proteinase inhibitor concentrates have been prepared from pooled human plasma for therapeutic applications. Pasteurization (60 degrees C, 10 hours) conditions have been defined to reduce risks of transmission of viral agents without significant loss of biologic activity of the purified product. Human clinical data collected to date support the model virus inactivation studies regarding viral safety.
摘要
α-1-蛋白酶抑制剂浓缩物已从混合人血浆中制备出来用于治疗用途。已确定巴氏消毒（60摄氏度，10小时）条件以降低病毒传播风险，同时纯化产品的生物活性不会有显著损失。迄今为止收集的人体临床数据支持了关于病毒安全性的模型病毒灭活研究。
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