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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。表明试制的四联疫苗具有较好的稳定性
Three batches of genetically engineered hepatitis B (Chinese hamster ovary cells) - diphtheria tetanus vaccine (r HB (CHO) - DTP) by self-test and the China Pharmaceutical and Biological Products Test of accreditation, the indicators have reached the national inspection program Claim. The levels of pertussis, diphtheria and tetanus antibodies were not significantly different from those before the stability test by 37 ℃ thermal stability test and 12 ~ 22 months long-term stability at 2-8 ℃ (P> 0). 0 5), gene hepatitis B ED50 ratio to 2 2 months at 1.5 1 ~ 2.13 between. That the trial of the quadruple vaccine has good stability