ACYW135群脑膜炎球菌多糖疫苗的研制

摘要

目的 通过研究冷酚与粗糖的混合比例、粗糖提纯时的质量浓度和乳糖保护剂的用量来制备符合规定的ACYW135群脑膜炎球菌多糖疫苗.方法 发酵细菌,提取A、C、W135、Y群脑膜炎球菌多糖粗制品,以不同的纯化工艺纯化A、C、W135、Y群脑膜炎球菌多糖.将4种纯化的多糖原液按一定比例混合,加入乳糖作为保护剂,冷冻干燥制成ACYW135群脑膜炎球菌多糖疫苗.结果 通过比较不同纯化工艺制备的多糖,确定最佳提纯条件为多糖与冷酚的体积比为1∶1,粗糖提纯时的质量浓度为6 g/L.检测按此纯化条件制备的ACYW135群脑膜炎球菌多糖疫苗显示,3批疫苗的水分含量分别为1.7％、2.0％和2.1％,疫苗的A、C、W135、Y群脑膜炎球菌多糖含量和回收率分别都≥50 μg/剂和80％,符合相关规定的要求.结论 按确定的工艺成功制备ACYW135群脑膜炎球菌多糖疫苗.%Objective To development qualified groups A,C,Y,W135 meningococcal polysaccharide vaccine (ACYW135-PS) by studying mixing ratio of phenol and crude polysaccharide,mass concentration of crude saccharide in purifying and dosage of lactose.Methods Bacteria were fermented,and crude saccharides of groups A,C,W135,Y meningococcus were extracted and purified by different purification processes.Groups A,C,W135 and Y meningococcal polysaccharide were mixed at a certain ratio,then lactose was added into mixture as stabilizer and ACYW135-PS was prepared by freeze-drying.Results The optimum conditions for crude saccharides purification were as follows:volume ratio of crude polysaccharide to phenol was 1 ∶ 1 and mass concentration of crude saccharide in purifying was 6 g/L.The results showed that moisture contents of 3 bathes of ACYW135-PS prepared according to these conditions were 1.7％,2.0％ and 2.1％,respectively,and polysaccharide contents and recovery rates of groups A,C,W135 and Y meningococcal polysaccharide in ACYW135-PS were all ≥50 μg/dose and 80％,respectively,complying with the relevant requirements.Conclusion ACYW135-PS is successfully prepared under confirmed conditions.