凝血酶冻干粉中猪蓝耳病毒感染情况考察  

Study on the infection of porcine reproductive and respiratory syndrome virus in lyophilizing thrombin powder

作　　者：聂希霖 邹浩勇 王智 王文晞 NIE Xi-lin;ZOU Hao-yong;WANG Zhi(Yujin bio-pharma Wuhan CNBG CO.,LTD.,Wuhan 430270,China)

机构地区：[1]武汉中生毓晋生物医药有限责任公司,武汉430070 [2]湖北省药品监督检验研究院,武汉430075

出　　处：《中国处方药》2023年第10期29-31,共3页Journal of China Prescription Drug

摘　　要：目的 评价来源于12家不同企业的20批凝血酶冻干粉中猪蓝耳病毒的感染情况。方法 采用荧光定量PCR法检测凝血酶冻干粉中猪蓝耳病毒核酸残留;以猴肾细胞(Marc-145)作为宿主细胞,通过待检样品感染宿主细胞,连续传代(5代)培养观察,以病毒致细胞病变(CPE)程度评估猪蓝耳病毒活性。结果 18批次样品检测出猪蓝耳病毒核酸残留,占总样品数的90%(18/20),未检测出有活性的猪蓝耳病毒。结论 凝血酶冻干粉中猪蓝耳病毒检出率高,提示该产品病毒残留风险较高,生产企业应在工艺中增加病毒灭活步骤,降低产品风险。Objective To evaluate the infection of porcine reproductive and respiratory syndrome virus(PRRSV)in 20 batches of lyophilizing thrombin powder from 12 different enterprises.Methods PRRSV nucleic acid residue in lyophilizing thrombin powder was detected by Quantitative Real-time PCR.The host cells(Marc-145)were infected by the samples.Five generation of cells were cultured continuously.The activity of PRRSV was evaluated by microscopic observation of the degree of cytopathic effect(CPE).Results Totally 18 batches of samples were detected out nucleic acid residue of PRRSV,which accounted for 90%of the total samples.No active PRRSV was detected out.Conclusion The higher detection rate of PRRSV in lyophilizing thrombin powder indicates the higher risk of virus residue.The virus inactivation process can be used to reduce the product’s risk.

关 键 词：凝血酶冻干粉 猪蓝耳病毒 细胞病变 

分 类 号：R927.1[医药卫生—药学]