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血液制品生产中人细小病毒B19安全性风险及控制策略

  • 吴强
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  • 成都蓉生药业有限责任公司生产管理部  610041

网络出版日期: 2025-08-16

Safety risk and controlling strategy of human pavovirus B19 in plasma derivative manufacturing

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  • Production Department, Chengdu Rongsheng Pharmaceuticals Co., Ltd, Chengdu 610041, China

Online published: 2025-08-16

摘要

血液制品因其原料特殊性,具有血源性病毒传播的风险。近20年来,随着病毒安全性控制技术的进步,血液制品传播HIV、HBV、HCV等主要病毒的风险已得到有效控制。人细小病毒B19(human parvovirus B19,B19V)等非脂包膜病毒已成为目前血液制品病毒安全性风险控制的焦点问题。与其他动物的细小病毒相比,B19V对酸、热更敏感,且因合并血浆中存在的B19V中和抗体,纳米过滤去除B19V的效果远优于对动物细小病毒的去除,通过合理优化病毒灭活条件,可有效灭活/去除B19V。此文就血液制品中B19V的现状和灭活/去除工艺研究进展做一综述。

本文引用格式

吴强 . 血液制品生产中人细小病毒B19安全性风险及控制策略[J]. 国际生物制品学杂志, 2020 , 43(1) : 46 -50 . DOI: 10.3760/cma.j.issn.1673-4211.2020.01.010

Abstract

 Plasma derivatives have source-caused risk of transmitting blood-borne virus . In the past 20 years, with the progress of virus safety controlling techniques, the risk of transmitting main viruses such as HIV, HBV, HCV by plasma derivatives has been well controlled. Non-enveloped viruses such as human parvovirus B19 (B19V) have become the focus of virus safety in plasma derivatives. Compared with animal parvoviruses, B19V is more sensitive to acid and heat. Because of the neutralizing antibody against B19V in plasma pools, removement of B19V by nanofiltration is more effective than that of animal parvoviruses. By optimizing the conditions of virus inactivation, B19V can be effectively inactivated or removed. This article reviews current situation of B19V in plasma derivatives and research progress of its inactivation/removal strategies.
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