A、C、W_(135)、Y群脑膜炎球菌多糖疫苗的研制

Preparation of Meningococcal Polysaccharide Vaccine Groups A,C,W_(135) and Y

目的研制A、C、W135、Y群脑膜炎球菌四价多糖疫苗,并采用新方法去除细菌内毒素。方法经细菌培养后,分别提取A、C、W135和Y群脑膜炎球菌荚膜多糖,纯化后,采用超速离心和层析技术相结合去除内毒素,按一定的配比制成四价多糖原液,加入保护剂,制成冻干疫苗,并进行检定。结果所研制的A、C、W135、Y群脑膜炎球菌多糖疫苗各项指标均达到了质控标准,内毒素含量小于10EU/μg,具有良好的安全性及有效性。结论已成功制备了A、C、W135、Y群脑膜炎球菌多糖疫苗。

Objective To prepare meningococcal polysaccharide vaccine groups A,C,W135 and Y and remove bacterial endotoxin by a novel method. Methods Culture meningococcus,then extract and purify capsular polysaccharide groups A, C, W135 and Y. After the bacterial endotoxin was removed by ultracentrafugation and affinity chromatography, the bulks of polysaccharide groups A, C, W135 and Y were mixed according to a certain ratio,then added with stabilizer and lyophilized to prepare tetravalent meningococcal polysaccharide vaccine. Perform control tests on the vaccine according to Chinese Requirements for Biologics（2000 Edition） and the requirements in Chinese Pharmacopoeia（2005 Edition）. Results All the indexes of prepared tetravalent meningococcal polysaccharide vaccine met the requirements for quality control. The vaccine was safe and effective, and its endotoxin content was not more than 10 EU/μg. Conclusion Meningococcal polysaccharide vaccine groups A,C, W135 and Y was successfully prepared.