b型流感嗜血杆菌多糖结合疫苗的研制  

Preparation of Hemophilus Influenza B Polysaccharide Conjugated Vaccine

作　　者：杨 耀 黄 镇 江 山 兰 芳 宋绍忠 栗克喜 张 云 黄 剑 黎云东 廖 颖 李凤祥[2] 何 莉[2] 袁曾麟[2] 

机构地区：[1]成都生物制品研究所,成都610063 [2]中国药品生物制品检定所,北京100021

出　　处：《中国生物制品学杂志》2002年第3期171-174,共4页Chinese Journal of Biologicals

摘　　要：［摘 要］目的 研制b型流感嗜血杆菌（Hib）结合疫苗并考察其稳定性。方法 用溴化氰活化提纯Hib荚膜多糖抗原，通过己二酰肼（ADH）与破伤风类毒素（TT）蛋白共价结合，制备b型流感嗜血杆菌结合物，并考察放置在2～8℃及室温9个月和37℃　3个月后的稳定性。结果 用本工艺提取的多糖，合成的多糖衍生物，多糖蛋白结合物的化学组成及结构特性均达到了国外同类产品的质控要求。结合物在2～8℃及室温放置9个月后基本无降解。结论 为临床评价Hib结合疫苗的安全性和保护效果及确定效期提供了实验基础。[Abstract] Objective To prepare Hemophilus influenza B(Hib)polysaccharide conjugated vaccine and study on its stability. Methods The capsular polysaccharide antigen of Hib was purified and activated with bromocyanogen and conjugated to tetanus toxoid protein by ADH, and the stability of the conjugate at 2 -8癈 and room temperature for 9 months or at 37癈 for 3 months were studied. Results All the chemical compositions and structural characters of the extracted polysaccharide, synthetic polysaccharide derivative and polysaccharide protein conjugate met the requirements for the imported products of the same kind. No significant degradation was observed after the vaccine was stored at 2 - 8癈 and room temperature for 9 months. Conclusion The study laid an experimental basis of evaluating the safety and protective effect of Hib conjugated vaccine as well as determine the validity period of it.

关 键 词：B型流感嗜血杆菌 多糖结合疫苗 研制 PRP抗原 

分 类 号：R373.13[医药卫生—病原生物学]