论文部分内容阅读
目的筛选冻干乙型脑炎灭活疫苗(Vero细胞)非动物源性稳定剂,以替代传统的动物源性稳定剂。方法取同一批乙型脑炎灭活疫苗(Vero细胞)原液,分别加入A、B、C、D稳定剂(非动物源性),制备成冻干剂型,分别检测其外观、水分、有效抗原含量和效力等,以传统稳定剂作对照,并考察其稳定性。结果冻干前后,疫苗的有效抗原含量及效力与对照无明显差异。加入D稳定剂(不含人血白蛋白和明胶)的冻干乙型脑炎灭活疫苗于37℃放置6个月,效力降低15.1%;于2～8℃放置2年,效力仍高于参考品。其他检测指标均符合要求。结论D稳定剂可替代传统稳定剂,用于制备冻干乙型脑炎灭活疫苗。
Objective To screen non-animal-derived stabilizers of lyophilized Japanese encephalitis inactivated vaccine (Vero cells) to replace traditional animal-derived stabilizers. Methods The same batch of Vero cells was inoculated into the same batch of Vero cells, respectively. A, B, C and D stabilizers (non-animal origin) were added to prepare lyophilized dosage forms. The appearance, Content and potency, with the traditional stabilizer as a control, and examine the stability. Results Before and after lyophilization, the effective antigen content and efficacy of the vaccine did not differ significantly from the control. Freeze-dried B encephalitis inactivated vaccine supplemented with D stabilizer (without human serum albumin and gelatin) placed at 37 ° C for 6 months resulted in a 15.1% reduction in potency; at 2-8 ° C for 2 years, efficacy was still above Reference. Other test indicators are in line with the requirements. Conclusion D stabilizer can replace the traditional stabilizer for the preparation of lyophilized Japanese encephalitis inactivated vaccine.