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目的 :探讨新城疫病毒活疫苗喷雾吸入剂的简便制备方法。方法 :用 SPF种蛋传种、扩增病毒 ,经超速离心等方法提纯后制成疫苗 ;以血凝试验等方法测定其滴度和活性 ;按生物制品的要求进行安全性试验。结果 :本疫苗能保持较高的生物学活性 ,并能达到临床前安全性的内控质量要求。结论 :用本法制备供肿瘤临床试验用的新城疫病毒活疫苗是可行的。
Objective: To explore a simple preparation method of live vaccine inhaler for Newcastle disease virus. Methods: SPF eggs were used to propagate the virus and purified by ultracentrifugation to make a vaccine. The titer and activity of the vaccine were determined by hemagglutination test and other safety tests according to the requirements of biological products. Results: The vaccine can maintain high biological activity, and can achieve the safety of pre-clinical quality control requirements. Conclusion: It is feasible to use this method to prepare live Newcastle disease virus vaccine for cancer clinical trials.