技术方法

猪纤维蛋白原生产工艺中病毒灭活效果验证

  • 张理火 ,
  • 薛磊
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  • 1上海利康瑞生物工程有限公司研发部, 上海 201707;2海军军医大学第二附属医院胸外科, 上海 200003

网络出版日期: 2025-08-16

基金资助

上海市军民融合发展专项项目(JMRHCY-2019-019);上海市产业发展项目(HCXBCY-2023-040)

Verification of virus inactivation process for porcine fibrinogen

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  • 1R&D Department, Shanghai Li Kang Rui Biological Engineering Co., Ltd., Shanghai 201707, China; 2Department of Thoracic Surgery, Second Affiliated Hospital of Naval Medical University, Shanghai 200003, China 

Online published: 2025-08-16

Supported by

The Project of Civil-Military Integration Development of Shanghai(JMRHCY-2019-019); Shanghai Industrial Development Project(HCXBCY-2023-040)

摘要

目的  验证和评价猪纤维蛋白原生产工艺中有机溶剂/去污剂(solvent/detergent,S/D)法联合干热法灭活病毒的有效性。方法  以辛德比斯病毒、乙型脑炎病毒和伪狂犬病毒为指示病毒,验证猪血浆S/D法灭活病毒的有效性;以脑心肌炎病毒和猪细小病毒为指示病毒,验证猪纤维蛋白原冻干制剂干热法灭活病毒的有效性。结果  S/D法中,辛德比斯病毒、乙型脑炎病毒和伪狂犬病毒清除滴度下降均大于4 lg;干热法中,脑心肌炎病毒和猪细小病毒清除滴度下降均大于4 lg。结论  S/D法和干热法联合能有效灭活上述指示病毒,可提高猪纤维蛋白原产品的安全性。

本文引用格式

张理火 , 薛磊 . 猪纤维蛋白原生产工艺中病毒灭活效果验证[J]. 国际生物制品学杂志, 2024 , 47(1) : 25 -28 . DOI: 10.3760/cma.j.cn311962-20230509-00041

Abstract

Objective  To verify and evaluate the efficacy of the solvent/detergent (S/D) method combined with dry-heating method to inactivate viruses in the preparation of porcine fibrinogen. Methods  Sindbis virus, Japanese encephalitis virus, and pseudorabies virus were used as indicator viruses for S/D virus inactivation. Encephalomyocarditis virus and porcine parvovirus were used as indicator viruses for dry-heating virus inactivation. Results  Reductions in titers of three indicator viruses by S/D method were >4 lg. Reductions in titers of two indicator viruses by dry-heating method were>4 lg. Conclusion  S/D method and dry-heating method combined effectively inactivate the indicator viruses, thus can improve the safety of porcine fibrinogen.
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