我国与WHO血液制品去除/灭活病毒技术方法与验证指导原则的比较研究  

Comparison of China and WHO Guidelines on Virus Removal/Inactivation Technical Methods and Validation of Blood Products

作　　者：徐宏山[1] 岳广智[1] 杨立宏[1] 刘欣玉[1] 李玉华[1] Xu Hongshan;Yue Guangzhi;Yang Lihong;Liu Xinyu;Li Yuhua(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药事》2023年第4期367-375,共9页Chinese Pharmaceutical Affairs

摘　　要：目的:比较我国现行《血液制品病毒去除/灭活验证指导原则》[国药监注(2002)160号]与世界卫生组织(WHO)《血液制品病毒去除/灭活验证指南》,旨在推动我国血液制品病毒风险控制与管理水平的提高及血液制品的合理应用。方法:从去除/灭活病毒方法的选择、常用去除/灭活病毒方法评价、特定的去除/灭活病毒方法验证、生产工艺去除/灭活病毒能力、去除/灭活病毒方法再验证、临床试验、输血用病毒灭活血浆和正在开发的新型病毒灭活方法等几个方面进行比较,对血浆及其制品生产工艺中病毒灭活/去除的相关方法及其验证进行研究。结果与结论:我国现行《血液制品病毒去除/灭活验证指导原则》与WHO《血液制品病毒去除/灭活验证指南》总体要求基本一致,对我国血液制品去除/灭活病毒技术方法与验证工作仍具有适用性和指导性。Objective:By comparing the current Guiding Principles for the Verification of Virus Removal/Inactivation of Blood Products[National Drug Administration Note(2002)No.160]with the World Health Organization's Guidelines for the Verification of Virus Removal/Inactivation of Blood Products,the purpose is to promote the improvement of virus risk control and management level of blood products and the rational application of blood products in China.Methods:The selection of virus removal/inactivation methods,evaluation of common virus removal/inactivation methods,validation of specific virus removal/inactivation methods,removal/inactivation capability of production processes,revalidation of virus removal/inactivation methods,clinical trials,virus-inactivated plasma for blood transfusion and new virus inactivation methods under development were compared.The relevant methods and verifi cation of virus inactivation/removal in the production process of plasma and its products were studied.Results and Conclusion:Our current Guiding Principles for the Verifi cation of Virus Removal/Inactivation of Blood Products are in accordance with the overall requirements of the WHO Guidelines for the Verifi cation Virus Removal/Inactivation of Blood Products,which still have applicability and guidance for the technical methods and verifi cation of virus removal/inactivation of blood products.

关 键 词：血液制品 世界卫生组织 病毒去除/灭活 病毒安全性 指导原则 方法与验证 

分 类 号：R95[医药卫生—药学] R457[生物学—微生物学] Q939.45