基因工程乙肝-百白破四联疫苗稳定性研究  

Studies on the Stability of Recombinant Hepatitis B DTP Combined Vaccine

作　　者：吕东升[1] 周平华[1] 艾智武[1] 徐炎军[1] 刘非[1] 汪玉兰[1] 

机构地区：[1]武汉生物制品研究所,武汉430060

出　　处：《同济医科大学学报》2000年第5期405-407,共3页Acta Universitatis Medicinae Tongji

基　　金：世界卫生组织资助 ;中国生物制品总公司课题! (No.96 D16 )

摘　　要：三批基因工程乙肝 (中华仓鼠卵巢细胞表达 ) -百白破四联疫苗 (r HB(CHO) - DTP)经自检和中国药品生物制品检定所检定 ,各项指标均达到国家制检规程的要求。通过 37℃热稳定试验和 2～ 8℃存放 12及 2 2个月长期稳定性的观察 ,百日咳、白喉、破伤风抗体的水平与稳定性试验之前比较 ,无显著性差异 (P均 >0 .0 5 ) ,基因乙肝 ED5 0比值至 2 2个月时在 1.5 1～ 2 .13之间。Three batches of recombinant hepatitis B DTP [rHB(CHO) DTP] vaccine were determined and qualified. All indexes were found to meet the requirements of Regulation for Biological Products. With the stability results from long term observation at 37 ℃ as well as 12/22 months at 2—8 ℃, compared with the stability test ago, all antibody levels of diphtheria, tetanus and pertussis vaccine had no significantly different ( P >0.05). When the rHB(CHO) DTP vaccine was reserved 22 months, ED50 of recombinant hepatitis B vaccine was ranged from 1.51 to 2.13. It was concluded that the manufactured combined vaccine had a satisfactory stability under the above conditions.

关 键 词：四联疫苗 稳定性 基因工程 乙肝-百白破四联疫苗 

分 类 号：R979.5[医药卫生—药品] R329－33[医药卫生—药学]