C群脑膜炎球菌多糖蛋白结合疫苗衍化工艺研究

Study on Derivation Technique of Serogroup C Meningococcal Polysaccharide For Conjugate Vaccine

目的筛选和优化C群脑膜炎多糖的衍化工艺。方法将C群奈瑟脑膜炎球菌多糖经溴化氰活化后通过己二酰肼衍生后制备出适宜的多糖衍生物。对衍化条件进行摸索和优化后通过衍化率及衍生物的可溶性来考察衍化效果,同时通过生化指标来考察该衍生工艺制备的结合疫苗的质量和收率。结果在pH11.0±0.2、活化30min以及溴化氰与多糖比值(W/W)=0.5时,所获衍生物制备的结合疫苗各项生化指标在所筛选的条件中最优。结论经过筛选优化的衍生工艺提高了多糖的衍化率,适于结合疫苗的研制,保证了结合疫苗的免疫原性。

Obhectuve Ti cinoare abd iotunuze tge deruvatuion technique of Serogroup C meningccoccal polysaccharide.Methods Feasible polysaccharide derivative was obtained by combining the serogroup C neisseria meningccoccal polysaccharide which was activated by cyanogen bromide（CNBr）with 1,6-adipic acid dihydrazide（ADH）,After we groped and optimized the derivation condition,we tested the derivation efficacy by detecting the derivation rate and the solubility of polysaccharide derivative,We tested the quality and the yield of conjugate vaccine by detecting biochemical indexes of them,Results Under the conditions of pH11.0±0.2、activation for 30 minutes and cyanogen bromide-polysaccharide ratio 0.5,all the biochemical indexes of conjugate vaccine were most excellent,Conclusions The optimized derivation technique can promote derivation rate of polysaccharide and can be applied to produce conjugate vaccine.It can also ensure the immunogenicity of conjugate vaccine.