【摘要】 目的对C群脑膜炎球菌多糖-破伤风类毒素结合疫苗进行研制。方法将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,制成C群脑膜炎球菌多糖结合疫苗原液,加保护剂冻干后制成C群脑膜炎球菌多糖结合疫苗。结果制备的冻干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C群脑膜炎球菌多糖结合疫苗,该制备工艺是可行的。更多还原

【Abstract】 PurposeTo prepare safe and valid Meningococcal Group C Bivalent polysaccharide conjugate vaccine.MethodsAt first,the Meningococcal Group C polysaccharides were activated with Cyanogen Bromide(CNBr),then they reacted with 1,6-adipic acid dihydrazide(ADH) and were bunded to the purified tetanus toxioid(TT) with carbodiimide(EDAC),then the original liquid of Meningococcal Group C polysaccharides conjugate was obtained.At last,the protectant was added in to it and dried by freezeing.ResultsAll the(targets) of the prepared vaccine fit the standard of quality control.The vaccine showed satisfactory safety and antigenicity.ConclusionThe technological process of the vaccine preparation is feasible.更多还原