冻干乙型脑炎灭活疫苗(Vero细胞)非动物源性稳定剂的筛选

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。

Screening of Non-animal-derived Stabilizer of Freeze-dried Inactivated Japanese Encephalitis Vaccine(Vero Cells)

Objective To screen a non-animal-derived stabilizer of freeze-dried inactivated Japanese encephalitis(JE) vaccine (Vero cells), instead of traditional animal-derived stabilizer. Methods The bulk of inactivated JE vaccine (Vero cells) of the same batch was added with stabilizers A, B, C and D, and prepared into freeze-dried vaccine respectively, then observed for appearance and determined for moisture, active antigen content and potency, using the vaccine containing traditional stabilizer as control, and evaluated for stability. Results The active antigen contents and potencies of vaccine using non-animal-derived stabilizers before and after lyophilization showed no significant difference with those using traditional stabilizer. The potency of freeze-dried inactivated JE vaccine using stabilizer D(containing no human albumin or gelatin)decreased by 15. 1% after storage at 37℃ for 6 months, and was still higher than that of reference after storage at 2 ～ 8℃ for 2 years. All the other quality indexes of the vaccine using non-animalderived stabilizer met the relevant requirements. Conclusion Stabilizer D may be used for preparation of freeze-dried inactivated JE vaccine(Vero cells)instead of traditional stabilizer.