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血液制品病毒检测与管控

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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.
Virus Detection and Control of Blood Products
Blood borne viral infections occur occasionally and the safety of blood products is of paramount impor-tance.The state has formulated a number of laws,regulations,departmental rules and technical guidelines for the safe-ty 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.

Blood productsVirus securityDetectionManagement and control

卢保丽、庞陈东

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广西冠峰生物制品有限公司,广西南宁 530299

血液制品 病毒安全性 检测 管控

2024

海峡药学
中国药学会福建分会

海峡药学

影响因子:0.643
ISSN:1006-3765
年,卷(期):2024.36(2)
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