冻干人用狂犬病纯化疫苗稳定剂的筛选  

Screening of stabilizer of freeze-dried rabies purified vaccine for human use

作　　者：李红芳[1] 邹勇[1] 徐斌[1] 李守丽[1] 张文权[1] 任宏伟[1] 郑学刚[1] 窦强[1] 王建军[1] 王玉琳[1] 

机构地区：[1]兰州生物制品研究所,兰州730046

出　　处：《微生物学免疫学进展》2005年第2期11-13,共3页Progress In Microbiology and Immunology

摘　　要：取同一批人用狂犬病纯化疫苗纯化液,分别加入筛选出的A、B、C和D稳定剂,按已确定的适宜冻干曲线进行冻干后,分别检测其安全、效力、外观、水分等,效力结果显示,使用A、B、D稳定剂的制品在37℃放置3个月,效价降低了48%～60%;使用C稳定剂的制品在37℃放置3个月效价仅下降了16.1%。表明C稳定剂为冻干人用狂犬病纯化疫苗适宜的稳定剂配方。Four kinds of stabilizer(A,B,C and D) were screened out, which were compared in different inspection for safety test, potency test, physical appearance and residual moisture after the preparations were lyophilized with the suitable freeze drying time course. The result showed that the potency of the preparation with the stabilizer C decreased by 16.1 % after being stored at 37℃ for 3 months, however the potency of product containing the stablizer A, B and D decreased by 48%-60%. Therefore, C is the optimal stabilizer candidate used for freeze-dried rabies purified vaccine for human use.

关 键 词：狂犬病疫苗 冻干 稳定剂 

分 类 号：R392[医药卫生—免疫学]