【摘要】 目的观察冻干A、C、W135、Y群脑膜炎球菌多糖疫苗在2～8℃保存的稳定性。方法将冻干A、C、W135、Y群脑膜炎球菌多糖疫苗放置在2～8℃条件下30个月,定期取样,观察其物理外观,进行鉴别试验,并测定多糖含量、分子大小、水分含量、异常毒性等质量控制指标,评价疫苗质量的稳定性。结果冻干A、C、W135、Y群脑膜炎球菌多糖疫苗于2～8℃30个月保存,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、W135、Y群脑膜炎球菌多糖疫苗在2～8℃保存,其质量稳定。更多还原

【Abstract】 Objective To observe the stability of freeze-dried meningococcal groups A,C,W135 and Y polysaccharide vaccine at 2～8℃.Methods Store freeze-dried meningococcal groups A,C,W135 and Y polysacchride vaccine at 2～8℃ for 30 months.Take samples periodically from the vaccine during storage for inspetion of final containers and tests for identity,polysaccharide content,molecular size,moisture content and abnomal toxicity to evaluate the stability.Results All the quality control indexes of vaccine complied with the requirements for registration of manufacturer.Conclusion Freeze-dried meningococcal groups A,C,W135 and Y polysaccharide vaccine showed good stability after storage at 2～8℃ for 30 months.更多还原