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目的筛选冻干乙型脑炎减毒活疫苗非动物源性稳定剂的配方及其缓冲液。方法分别以0.01 mol/L PBS和Earles液为缓冲液,右旋糖苷-70、蔗糖、山梨醇、乳糖及组氨酸不同组合构成的冻干稳定剂,制备乙型脑炎减毒活疫苗半成品及冻干疫苗成品,观察在不同温度存放不同时间的稳定性,并检测不同配方冻干稳定剂的崩解温度(Tc)。结果 12种配方冻干稳定剂制成的疫苗半成品可在4℃1周内保持滴度稳定性,在25℃3 d内保持滴度无明显变化,3 d后滴度大幅下降;以0.01 mol/L PBS为缓冲液的稳定剂制备的疫苗的Tc值低于Earles液,以Earles液为缓冲液的D2和F2配方制备的冻干疫苗成品,在4℃及37℃放置1周后,滴度均>5.7 logPFU/ml。结论已筛选出以Earles液为缓冲液,含右旋糖苷-70、蔗糖、山梨醇、乳糖及组氨酸的稳定剂配方,用于制备冻干乙型脑炎减毒活疫苗具有良好的保护效果。
Objective To screen the formulation and buffer of non-animal-derived stabilizer of live attenuated JE vaccine. Methods The semi-finished live attenuated JE vaccine was prepared with 0.01 mol / L PBS and Earles solution as buffer, dextran-70, sucrose, sorbitol, lactose and histidine And freeze-dried vaccine products were observed at different temperatures stored at different times of stability, and test different formulations freeze-drying stabilizer disintegration temperature (Tc). Results The half-finished vaccine of 12 kinds of freeze-dried stabilizer could maintain the titer stability within 1 week at 4 ℃, keep the titer unchanged within 3 days at 25 ℃, / L PBS Vaccine prepared as a buffer stabilizer had a lower Tc value than the Earles solution and the freeze-dried vaccine preparation prepared with the Earles solution as a buffer D2 and F2 formulation, and left for 1 week at 4 ° C and 37 ° C. Degree were> 5.7 logPFU / ml. CONCLUSIONS Earlels solution was used as buffer solution containing dextran-70, sucrose, sorbitol, lactose and histidine as stabilizers, which has good protection for preparing live attenuated JE vaccine effect.