冷冻干燥对重组酵母乙型肝炎疫苗效力(抗原性)的影响  

The effect of freeze-drying on the potency of recombinant yeast hepatitis B vaccine

作　　者：张弛[1] 梁争论[1] 李津[2] 胡忠玉[2] 钟熙[1] 星海[2] 唐巧英[2] 张华远[1] 李河民[1] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]北京生物制品研究所,北京100036

出　　处：《微生物学免疫学进展》2003年第2期16-18,共3页Progress In Microbiology and Immunology

摘　　要：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。Three bulks of freeze dried recombinant hepatitis B vaccines were prepared by adding 5% saccharose and 1% gelatine as stabilizer.There were no significant differences both in relative potency in vitro and mouse ED 50 between freeze dried vaccine and liquid one.The stability of freeze dried vaccine was superior to that of liquid one,at 4℃ storage and after heating acceleration test.The results provided basis to preparation stable reference in freeze dried form for the vaccine production.

关 键 词：乙肝疫苗 稳定性 参考品 冷冻 

分 类 号：R392[医药卫生—免疫学]