目的 评价b型流感嗜血杆菌(Haemophilus inflluenzae 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.
Structural stability of Hib capsular polysaccharide in vaccine manufacturing
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 polysa-ccharides,polysaccharide derivatives and protein-conjugated polysaccharides all met the requirements of relevant standards of Chinese Pharmacopoeia(Volume Ⅲ,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.
Haemophilus influenzae type b(Hib)Capsular polysaccharidePolyribosylribitol phosphate(PRP)Nuclear magnetic resonance spectroscopy(NMR)StructureStability
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