论文部分内容阅读
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。
Objective To observe the stability of freeze-dried A, C, W135, Y meningococcal polysaccharide vaccine at 2-8 ℃. Methods The meningococcal polysaccharide vaccine of group A, C, W135 and Y was lyophilized at 2-8 ℃ for 30 months. Samples were taken periodically to observe the physical appearance of the polysaccharide vaccine. The polysaccharide content, molecular size, water content Content, abnormal toxicity and other quality control indicators to evaluate the stability of the vaccine quality. Results The lyophilized A, C, W135 and Y meningococcal polysaccharide vaccines were stored at 30 ℃ for 2 ~ 8 ℃ for 30 months, and the quality control indexes still met the registration standards of the vaccine enterprises. Conclusion Lyophilized meningococcal polysaccharide vaccine A, C, W135 and Y were preserved at 2-8 ℃, and their quality was stable.