Hib荚膜多糖在疫苗制备周期中的结构稳定性  

Structural stability of Hib capsular polysaccharide in vaccine manufacturing

作　　者：张腾腾 秦春君 尹珊珊[1] 刘翠[1] 刘建凯[1] 尹健 佟巍[1] ZHANG Tengteng;QIN Chunjun;YIN Shanshan;LIU Cui;LIU Jiankai;YIN Jian;TONG Wei(Beijing Minhai Biotechnology Co.,Ltd.,Beijing 102600,China;不详)

机构地区：[1]北京民海生物科技有限公司,北京102600 [2]江南大学生物工程学院糖化学与生物技术教育部重点实验室,江苏无锡214122

出　　处：《中国生物制品学杂志》2024年第2期129-137,共9页Chinese Journal of Biologicals

基　　金：国家科技重大专项(2015ZX09108005)。

摘　　要：目的 评价b型流感嗜血杆菌(Haemophilus influenzae type b,Hib)荚膜多糖的基本结构聚核糖基核糖醇磷酸酯(polyribosylribitol phosphate,PRP)在Hib结合疫苗制备过程中的稳定性。方法 采用核磁共振波谱(nuclear magnetic resonance spectroscopy,NMR)技术对制备的Hib精制多糖、多糖衍生物、多糖蛋白结合物进行结构解析。结果 制备的Hib精制多糖、多糖衍生物、多糖蛋白结合物的各项检测结果均符合《中国药典》三部(2020版)相关标准要求,且NMR谱图均未发生明显变化。结论 Hib结合疫苗主要抗原荚膜多糖的基本结构PRP在疫苗制备周期中未发生变化。Objective To evaluate the stability of polyribosylribitol phosphate(PRP),the basic structure of capsular polysaccharide of Haemophilus influenzae type b(Hib),in the preparation of Hib conjugate vaccine.Methods The structures of the prepared Hib polysaccharides,polysaccharide derivatives and protein-conjugated polysaccharides were analyzed by nuclear magnetic resonance spectroscopy(NMR).Results The detection results of the prepared Hib polysaccharides,polysaccharide derivatives and protein-conjugated polysaccharides all met the requirements of relevant standards of Chinese Pharmacopoeia(VolumeⅢ,2020 edition),and the NMR spectra showed no significant change.Conclusion The basic structure PRP of the main carbohydrate antigen of Hib conjugate vaccine had no change during the vaccine manufacturing.

关 键 词：B型流感嗜血杆菌 荚膜多糖 聚核糖基核糖醇磷酸酯 核磁共振波谱法 结构 稳定性 

分 类 号：Q819[生物学—生物工程] Q71[理学—高分子化学] O636.9[理学—化学]