【摘要】 目的观察冻干A、C群脑膜炎球菌多糖结合疫苗在2~8℃条件下的稳定性。方法将冻干A、C群脑膜炎球菌多糖结合疫苗放置在2~8℃条件下,定期取样,检查其物理外观,检测多糖含量、水分含量和分子大小,并进行鉴别试验以及异常毒性和免疫原性试验,考察其稳定性。结果冻干A、C群脑膜炎球菌多糖结合疫苗于2~8℃保存30个月,各项质量控制指标仍符合该疫苗企业注册标准。结论冻干A、C群脑膜炎球菌多糖结合疫苗在2~8℃条件下,其质量稳定。更多还原

【Abstract】 Objective To explore the stability of freeze-dried groups A and C meningococcal polysaccharide conjugate vaccine at 2-8℃.Methods Store freeze-dried groups A and C meningococcal polysaccharide conjugate vaccine at 2-8℃ for 30 months.Take samples periodically for inspection of final containers,identity test,abnormal toxicity test,immunogenicity test as well as determination of polysaccharide content,moisture content and molecular size to evaluate the stability of vaccine.Results All the quality control indexes of freeze-dried groups A and c meningococcal polysaccharide conjugate vaccine after storage at 2-8℃ for 30 months met the requirements for product license.Conclusion Freeze-dried groups A and C meningococcal polysaccharide conjugate vaccine showed good stability at 2-8℃.更多还原