论文部分内容阅读
目的:验证纳米膜过滤法和低pH孵放法去除/灭活静注人免疫球蛋白中病毒的效果。方法:纳米膜过滤法选用猪细小病毒为指示病毒，低pH孵放法选用水疱性口炎病毒、辛德比斯病毒、HIV和伪狂犬病毒为指示病毒，高浓度静注人免疫球蛋白在pH4.6～5.0、30～32 ℃条件下作用不同时间后，取样检测样品中残余病毒滴度以评价病毒灭活效果。结果:纳米膜过滤可降低猪细小病毒滴度达4.50～4.68 lg，低pH孵放法对伪狂犬病毒、辛德比斯病毒、水疱性口炎病毒、HIV等指示病毒的滴度降低量均大于4 lg。结论:纳米膜过滤法和低pH孵放法均能有效去除/灭活指示病毒，提高静注人免疫球蛋白产品的安全性。“,”Objective:To verify the efficacy of nanofiltration and incubation with low pH to remove/inactivate the viruses in human immunoglobulin for intravenous injection.Methods:Porcine parvovirus (PPV) was used as the indicator virus for nanofilm filtration virus removal.Low pH incubation method used vesicular stomatitis virus (VSV), Sindbis virus (Sindbis), HIV and pseudo-rabies virus (PRV) as indicator viruses. High concentration human immunoglobulin for intravenous injection was incubated under pH4.6-5.0, 30-32 ℃ conditions for different time, then sampled and tested for the residual virus titer to evaluate the effect of virus inactivation.Results:The removal of PPV by nanofilm filtration was 4.50-4.68 lg, and the titer reductions of PRV, Sindbis, VSV and HIV were all >4 lg.Conclusion:Both nanofiltration and incubation with low pH can effectively remove/inactivate the indicator viruses and improve the safety of human immunoglobulin for intravenous injection.