A+C群脑膜炎球菌多糖结合疫苗的研制  

Preparation of Group A+C Meningococcal Polysaccharide Conjugate Vaccine

作　　者：黄镇 钱雯 袁琳 施競 陈燕 陈南萍 周红军 李文春[2] 杨美峰[2] 刘红岩[3] 

机构地区：[1]云南沃森生物技术有限公司,昆明650118 [2]云南大学药学院,昆明650091 [3]云南大学生物制药创新人才培养基地,昆明650091

出　　处：《中国生物制品学杂志》2005年第6期483-486,共4页Chinese Journal of Biologicals

摘　　要：目的研制A+C群脑膜炎球菌多糖-破伤风类毒素结合疫苗。方法A群和C群脑膜炎球菌多糖在溴化氰(CNBr)的活化下,以1,6己二酰肼(ADH)作为连接子,与精制破伤风类毒素(TT)在碳二亚胺(EDAC)作用下结合,再按一定的比例将两者混合,制成A+C群脑膜炎球菌多糖结合疫苗原液,加保护剂冻干后,制成A+C群脑膜炎球菌多糖结合疫苗。结果经检定,A+C群脑膜炎球菌多糖结合疫苗各项指标均达到了质控标准。该疫苗安全性及免疫原性良好。结论已成功研制出冻干A+C群脑膜炎球菌多糖结合疫苗,该制备工艺是可行的。Objective To prepare group A ＋ C meningococcal polysaccharide conjugate vaccine.Methods Activate groups A and C meningococcal polysaccharide with cyanogens bromide（CNBr） and prepare into MenAPS-ADH and MenCPS-ADH derivatives by reacting with 1,6-adipic acid dihydrazine（ADH）. Mix MenAPS-ADH and MenCPS-ADH derivatives with purified tetanus toxoid（TT） at a certain mass ratio, then add 1-ethyl-3（3-dimethylaminopropyl）-carbodiimide（EDAC） to prepare bulks of MenAPS-TT and MenCPS-TT conjugates respectively. Mix the two bulks at a certain ratio, add stabilizer and lyophilize to prepare group A ＋ C meningococcal polysaccharide conjugate vaccine. Results All the indexes of the prepared A ＋ C meningococeal polysaccharide conjugate vaccine met the standard for quality control. The vaccine showed good safety and immunogenicity. Conclusion Freeze-dried A＋ C meningococcal polysaccharide conjugate vaccine was successfully prepared, and the production procedure was feasible.

关 键 词：A+C群脑膜炎球菌多糖 结合疫苗 破伤风类毒素 免疫原性 制备工艺 

分 类 号：R512.3[医药卫生—内科学] R517.3[医药卫生—临床医学]