无细胞百白破b型流感嗜血杆菌联合疫苗的研制  

Preparation of Acellular Pertussis, Diphtheria, Tetanus and Haemophilus influenza Type b Combined Vaccine

作　　者：李贵凡[1] 郑海发[1] 尹姗姗[1] 

机构地区：[1]北京民海生物科技有限公司,北京102600

出　　处：《中国生物制品学杂志》2008年第9期790-791,共2页Chinese Journal of Biologicals

摘　　要：目的研制无细胞百白破b型流感嗜血杆菌联合疫苗(DTaP/Hib)。方法按不同抗原配比配制3组联合疫苗,分别检测疫苗的效价及安全性,从中选择最佳配比配制3批联合疫苗,并用相应批原液,按相同配比配制3批DTaP和3批Hib疫苗作为对照,检测联合疫苗中抗原的相容性。结果3组配比的联合疫苗效价及安全性均达到《中国药典》三部(2005版)要求,联合疫苗中以每毫升含AcP18μgPN、D25Lf、T7Lf和Hib多糖抗原20μg为最佳配比。动物实验证明联合疫苗各抗原间不存在免疫干扰。结论已成功研制4种抗原配比合理的DTaP/Hib联合疫苗。Objective To prepare acellular pertussis, diphtheria, tetanus and Haemophilus influenza type b （DTaP/Hib） combined vaccine. Methods DTaP/Hib combined vaccine was prepared by mixing the antigens in various ratios and tested for titer and safety respectively, based on which the formula was optimized. Three batches of combined vaccine was prepared according to the optimal formula and tested for antigen compatibility, using DTaP and Hib vaccines prepared with the bulk of the same batches as those for preparation of combined vaccine as control. Results The titers and safeties of combined vaccine prepared according various formula met the requirements in Chinese Pharmacopoeia （Volume Ⅲ, 2005 ）. Each milliliter of combined vaccine prepared according to the optimal formula contained 18 μg of acellular pertussis antigen, 25 Lf of diphtheria toxoid, 7 Lf of tetanus toxoid and 20μg of Hib polysaccharide antigen. Animal test showed no immune interference between the various antigens in the combined vaccine. Conclusion The DTaP/Hib combined vaccine with rational formula were successfully prepared.

关 键 词：无细胞百白破疫苗 b型流感嗜血杆菌疫苗 联合疫苗 

分 类 号：R378.41[医药卫生—病原生物学] R392.33[医药卫生—基础医学]