凝血酶冻干粉中口蹄疫病毒感染情况考察

Study on the Infection of Food-and-mouth Disease Virus in Lyophilizing Thrombin Powder

目的:评价来源于12个不同厂家的52批凝血酶冻干粉中口蹄疫病毒感染情况。方法:采用逆转录PCR法检测凝血酶冻干粉中口蹄疫病毒核酸残留;以地鼠肾细胞(BHK-21)作为宿主细胞,用待检样品感染宿主细胞,连续传代(5代)培养,显微观察病毒致细胞病变(CPE)程度评估口蹄疫病毒活性。结果:28批样品检测出口蹄疫病毒核酸残留,占样品总数的53.8%,未检测出有活性的口蹄疫病毒。结论:凝血酶冻干粉中口蹄疫病毒核酸残留检出率较高,提示该产品有一定的安全隐患,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 foot-and-mouth disease virus( FMDV) in 52 batches of lyophilizing thrombin powder from 12 different manufacturers. Methods: FMDV nucleic acid residue in lyophilizing thrombin powder was detected by RTPCR. The host cells( BHK-21) were infected by the samples. Five generations of cells were cultured continuously. The activity of footand-mouth disease virus( FMD) was evaluated by microscopic observation of the degree of cytopathic effect( CPE). Results: Totally28 batches of samples were detected out nucleic acid residue of FMDV,which accounted for 53.8% of the total samples. No active FMDV was detected out. Conclusion: The detection rate of foot-and-mouth disease virus nucleic acid residues in lyophilizing thrombin powder is high,indicating the product has certain security risk.