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短波紫外线对人凝血因子Ⅷ中猪细小病毒灭活的研究

  • 李冬梅 金晶 是翡 石玮 吴腾捷 吴晓文 吴玮
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  • 200051 上海生物制品研究所有限责任公司第七研究室(李冬梅、吴晓文、吴玮),第五研究室(吴腾捷),质量检定室(石玮);国药集团上海血液制品有限公司血液研发室(金晶、是翡)

网络出版日期: 2025-08-16

Study in inactivation of porcine parvovirus in human coagulation factor Ⅷ by short-wave ultraviolet C

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  • ﹡No.7 Research Laboratory, Shanghai Institute of Biological Products Co. Ltd.,Shanghai 200051, China

Online published: 2025-08-16

摘要

目的  研究短波紫外线(short-wave ultraviolet C,UV-C)对人凝血因子Ⅷ(human coagulation factor Ⅷ ,FⅧ)中猪细小病毒(porcine parvovirus ,PPV)的灭活的效果。方法  将PPV作为指示病毒与FⅧ中间品混合,用紫外灭活仪UVivatec分别以200、300 和400 J/m2 UV-C进行灭活。将UV-C灭活的FⅧ接种ST细胞并进行培养,采用细胞病变(cytopathic effect,CPE)法检测病毒,并以Reed-Muench法计算病毒滴度。对所有UV-C灭活后未出现CPE的样品盲传3 代,验证灭活效果;同时对UV-C灭活前后的FⅧ活性进行检测。结果  3个照射剂量的UV-C灭活后,FⅧ中的PPV滴度降低均0.1 ml ≥4.62 lg半数组织培养感染剂量,所有未出现CPE的样品盲传至第3代均未检到病毒。UV-C灭活的FⅧ的活性无明显降低,且各项质量指标均符合药典的要求。结论  UV-C可有效灭活无包膜病毒 PPV,且对FⅧ活性无明显影响。

本文引用格式

李冬梅 金晶 是翡 石玮 吴腾捷 吴晓文 吴玮 . 短波紫外线对人凝血因子Ⅷ中猪细小病毒灭活的研究[J]. 国际生物制品学杂志, 2017 , 40(5) : 228 -231 . DOI: 10.3760/cma.j.issn.1673-4211.2017.05.005

Abstract

Objective  To investigate the effect of short -wave ultraviolet- C(UV-C)on inactivating porcine parvovirus(PPV)in human coagulation factor Ⅷ (FⅧ). Methods  PPV was mixed with the FⅧ intermediate as an indicator virus. The FⅧ intermediates containing PPVs were inactivated using UVivatec instrument with 200, 300 and 400 J/m2 UV-C. The FⅧs inactivated by UV-C were inoculated in ST cells and cultured. PPV was detected by cytopathic effect (CPE) method and the virus titer was calculated by Reed-Muench method. The samples without CPE were cultured 3 blind passages to verify the inactivation effect. At the same time, the FⅧ activities before and after UV-C inactivation were detected. Results  The PPV titers in FⅧ all decreased more than 4.62 lg 50% tissue culture infective per0.1ml after UV-C inactivation with 3 different exposure doses. PPVs were not detected in the samples without CPE cultured to 3rd blind passage. The activities of FⅧ inactivated by UV-C did not decrease significantly, and each quality index met the requirements of pharmacopeia. Conclusion  UV-C can inactivate nonenveloped virus PPV, and has no influence on the FⅧ activity.
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