运用S/D法和膜过滤法对人凝血因子Ⅸ中辛德毕斯病毒和猪细小病毒灭活/去除效果的验证  

Verification for effect of virus inactivation/removal in human coagulation factorⅨby solvent/detergent and membrane filtration

作　　者：杨立宏[1] 岳广智[1] 徐宏山[1] 李玉华[1] 叶强[1] 刘欣玉[1] YANG Lihong;YUE Guangzhi;XU Hongshan;LI Yuhua;YE Qiang;LIU Xinyu(Division of Arboviral vaccines,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虫媒病毒疫苗室,北京102629

出　　处：《微生物学免疫学进展》2024年第4期30-33,共4页Progress In Microbiology and Immunology

摘　　要：目的验证运用有机溶剂/去污剂(S/D)处理法和膜过滤法对人凝血因子Ⅸ中辛德毕斯病毒(Sindbis virus)和猪细小病毒(porcine parvovirus,PPV)的灭活/去除效果。方法采用S/D处理法灭活人凝血因子Ⅸ中添加的Sindbis virus,噬斑滴定法检测灭活前后的病毒滴度;膜过滤法去除添加的PPV,细胞病变法检测去除前后的病毒滴度。结果经S/D处理法灭活后,3批人凝血因子Ⅸ中Sindbis virus降低量分别为>4.62 lgPFU/mL、>4.64 lgPFU/mL、>4.50 lgPFU/mL。经Planova 15N膜过滤后,3批人凝血因子Ⅸ中PPV降低量分别为≥4.50 lgTCID50/0.1 mL、≥4.56 lgTCID50/0.1 mL、≥4.38 lgTCID50/0.1 mL。结论通过对指示病毒的验证效果评估,证明运用S/D法和膜过滤法对人凝血因子Ⅸ中的Sindbis virus和PPV均有较好的灭活/去除效果。Objective To verify the effect of solvent/detergent(S/D)treatment and membrane filtration for inactivation and removal of Sindbis virus and porcine parvovirus(PPV)in human coagulation factorⅨ.Methods The Sindbis virus in human coagulation factorⅨwas inactivated by the S/D treatment,and the virus titer before and after inactivation was detected using the plaque assay;Membrane filtration method was used to remove porcine parvovirus(PPV),and cytopathic assay was used to detect the virus titer before and after removal.Results After inactivation by the S/D method,the reductions of Sindbis virus in three batches of human coagulation factorⅨwere>4.62 lgPFU/mL,>4.64 lgPFU/mL,and>4.50 lgPFU/mL,respectively.After filtration with Planova 15N membrane,the reductions of PPV in three batches of human coagulation factorⅨwere≥4.50 lgTCID_(50)/0.1 mL,≥4.56 lgTCID_(50)/0.1 mL,and≥4.38 lgTCID_(50)/0.1 mL,respectively.Conclusion By evaluating the validation effect of the indicator viruses,it has been proven that the S/D treatment and membrane filtration method has good inactivation and removal effect on the Sindbis virus and PPV in human coagulation factorⅨ.

关 键 词：有机溶剂/去污剂处理法 膜过滤法 人凝血因子Ⅸ 辛德毕斯病毒 猪细小病毒 病毒灭活 

分 类 号：R392-33[医药卫生—免疫学]