血液制品病毒检测与管控  

Virus Detection and Control of Blood Products

作　　者：卢保丽 庞陈东 LU Bao-li;PANG Chen-dong(Guangxi Guanfeng Biological Products Co.,LTD,Nanning 530299,China)

机构地区：[1]广西冠峰生物制品有限公司,广西南宁530299

出　　处：《海峡药学》2024年第2期107-110,共4页Strait Pharmaceutical Journal

摘　　要：经血液制品传播的病毒感染偶有发生,血液制品安全性至关重要。国家已针对血液制品病毒安全性制定了多部法律、条例、部门规章以及技术指导原则对其严管。本文整理了国内现行法规关于病毒安全的相关条款,比对病毒检测方法,对生产过程中病毒灭活/去除工艺进行了综述,旨在为血液制品的病毒风险管控提供借鉴。Blood borne viral infections occur occasionally and the safety of blood products is of paramount importance.The state has formulated a number of laws,regulations,departmental rules and technical guidelines for the safety of blood products.In this paper,relevant provisions of current domestic laws and regulations on virus safety were collated,virus detection methods were compared,and virus inactivation/removal processes in the production process were reviewed,aiming to provide reference for virus risk control of blood products.

关 键 词：血液制品 病毒安全性 检测 管控 

分 类 号：R95[医药卫生—药学]