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重组酵母乙型肝炎疫苗 (酵母乙肝疫苗 )加入保护剂后冷冻干燥 ,观察是否影响疫苗抗原性和稳定性。按 5 %和 1%的比例 ,在酵母乙肝疫苗原液中分别加入蔗糖和明胶 ,低温冷冻干燥 ,制备 3批冻干疫苗 ,分别进行体外相对效力和小鼠ED50 测定。加保护剂冻干后酵母乙肝疫苗体外相对效力和小鼠ED50 值较冻干前改变不大 ,而 4℃放置和热加速后的稳定性均优于液体疫苗。因此现有酵母乙肝疫苗加入保护剂冻干后 ,显著提高了疫苗的稳定性 ,为进一步制备稳定的疫苗参考品打下了初步基础。
Recombinant yeast Hepatitis B vaccine (yeast hepatitis B vaccine) after adding protective agent freeze-dried to observe whether the vaccine antigenicity and stability. Three batches of freeze-dried vaccine were prepared by adding sucrose and gelatin to the yeast hepatitis B vaccine stock at the ratio of 5% and 1%, respectively. The relative efficacy in vitro and the ED50 of the mice were determined. Yeast Hepatitis B vaccine plus protective agent lyophilized in vitro relative efficacy and mouse ED50 values did not change much before freeze-drying, and 4 ℃ after the placement and thermal stability are better than the liquid vaccine. Therefore, the existing yeast hepatitis B vaccine added protective agent after lyophilization significantly improved the stability of the vaccine for the further preparation of a stable vaccine reference laid the preliminary foundation.