甲型肝炎减毒活疫苗冻干保护剂的研究  

Preparation of Protective Additive of Freeze-dried Live Attenuated Hepatitis A Vaccine

作　　者：李光谱[1] 刘景晔[1] 王鹏富[1] 李淑焱[1] 张喜珍[1] 刘晶[1] 

机构地区：[1]长春生物制品研究所,长春130062

出　　处：《中国生物制品学杂志》2002年第6期361-362,共2页Chinese Journal of Biologicals

摘　　要：目的 研究冻干甲型肝炎减毒活疫苗的保护剂。方法 甲型肝炎病毒L-A-l株经2BX二倍体细胞培养,制备成甲型肝炎减毒活疫苗,再添加不同保护剂进行冷冻干燥。结果 以山梨醇、蔗糖、脂肪酸盐等为主的保护剂,对甲型肝炎减毒活苗病毒显示了较好的保护性,疫苗冻干前后感染滴度下降在1.0Log CCID50/ml以内,符合《中国生物制品规程》要求。结论 以山梨醇、蔗糖、脂肪酸盐等为主的保护剂是一种安全性较高、疫苗冻干效果较好,适合于疫苗规模化生产的保护剂。Objective To prepare a protective addivive of freeze-dried live attenuated hepatitis A vaccine . Methods Live attenuated hepatitis A vaccine was prepared by culture of HA virus L - A - 1 strain in 2BX cells and lyophilized after addition of various protective additives. Results The protective additive composed of sorbite, sucrose, etc. showed good protective effect on live attenuated HA vaccine. The infectious liters of the vaccine decreased by not more than 1.0 Log CCID50 /ml after lyophilization. The result meets the Chinese Requirements for Biologies. Conclusion The protective additive composed of sorbite, sucrose, etc. was safe and effective, and suitable for the large - scale production.

关 键 词：甲型肝炎减毒活疫苗 冻干保护剂 配方 保护机理 

分 类 号：R373.21[医药卫生—病原生物学] R392－33[医药卫生—基础医学]