S/D处理法和干热法用于C1酯酶抑制剂病毒灭活的效果验证  

Verification for effect of virus inactivation in C1 esterase inhibitor by solvent/detergent and dry heating

作　　者：杨立宏[1] 岳广智[1] 徐宏山[1] 刘欣玉[1] 叶强[1] YANG Li-hong;YUE Guang-zhi;XU Hong-shan;LIU Xin-yu;YE Qiang(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：《药物分析杂志》2025年第1期104-109,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:验证运用有机溶剂/去污剂(S/D)处理法和干热法对C1酯酶抑制剂(C1-INH)中病毒灭活效果。方法:采用S/D处理法灭活含S/D样品中添加的辛德毕斯病毒,噬斑滴定法检测灭活前后的病毒滴度,-干热法灭活脑心肌炎病毒(EMCV)和猪细小病毒(PPV),细胞病变法检测灭活前后的病毒滴度。结果:经S/D处理法灭活后,3批含S/D样品中辛德毕斯病毒降低量分别为>4.35 lg PFU·mL^(-1)、>4.51 lg PFU·mL^(-1)、>4.64 lg PFU·mL^(-1)。经干热法灭活后,3批不含S/D样品中EMCV降低量分别为≥5.38 lg TCID_(50)/0.1 mL、≥5.12 lg TCID_(50)/0.1 mL、≥5.25 lg TCID_(50)/0.1 mL,PPV降低量分别为4.57 lg TCID_(50)/0.1 mL、4.18 lg TCID_(50)/0.1 mL、4.68 lg TCID_(50)/0.1 mL。结论:通过对指示病毒的验证效果评估,证明S/D法和干热法对C1-INH中的辛德毕斯病毒、EMCV和PPV均有较好的灭活效果。Objective:To confirm the validity of solvent/detergent(S/D)treatment and dry heating for inactivation of virus in C1 esterase inhibitor(C1-INH).Methods:The Sindbis virus in samples with S/D was inactivated by the S/D method,and the virus titer before and after inactivation was detected using the plaque assay.Dry heating method was used to inactivate encephalomyocarditis virus(EMCV)and porcine parvovirus(PPV),and cytopathic assay was used to detect the virus titer before and after inactivation.Results:After inactivation by the S/D method,the reductions of Sindbis virus in three batches of smaples with S/D were>4.35 lg PFU·mL^(-1),>4.51 lg PFU·mL^(-1),>4.64 lg PFU·mL^(-1),respectively.After dry heating,the reductions of EMCV in three batches of samples without S/D were≥5.38 lg TCID_(50)/0.1 mL、≥5.12 lg TCID_(50)/0.1 mL、≥5.25 lg TCID_(50)/0.1 mL,respectively,and the reductions of PPV in three batches of samples without S/D were 4.57 lg TCID_(50)/0.1 mL、4.18 lg TCID_(50)/0.1 mL、4.68 lg TCID_(50)/0.1 mL,respectively.Conclusion:With evaluation on the inactivation capability of the indicator viruses,it is proved that the S/D treatment and dry heating has good inactivation and removal effect on the virus in C1-INH.

关 键 词：有机溶剂/去污剂处理法 干热法 C1酯酶抑制剂 病毒灭活 辛德毕斯病毒 脑心肌炎病毒 猪细小病毒 

分 类 号：R917[医药卫生—药物分析学]