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.
出处
《同济医科大学学报》
CSCD
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 )
