23价肺炎球菌多糖疫苗稳定性考察

目的:考察23价肺炎球菌多糖疫苗在2～8℃条件存放24,27个月的稳定性,以及在(37±2)℃和(25±2)℃条件下存放的加速稳定性。方法:选取2008年生产的3批23价肺炎球菌多糖疫苗在2～8℃存放24,27个月后进行外观检查、鉴别试验、多糖含量、pH值、苯酚含量、氯化钠含量、无菌检查、热原检查、异常毒性检查;选取2011年生产的3批23价肺炎球菌多糖疫苗在(37±2)℃条件分别存放1,2,3,4周和在(25±2)℃条件分别存放1,2,3个月后进行鉴别试验和多糖含量测定、外观检查、pH值和苯酚含量测定。结果:疫苗2～8℃存放24,27个月,检定结果均符合质量标准的要求;疫苗(37±2)℃和(25±2)℃存放分别从第3周和第2个月开始,个别型别的多糖含量低于质量标准要求,其余各项检测指标均符合质量标准的要求。结论:23价肺炎球菌多糖疫苗在2～8℃条件存放至24个月的有效期质量是稳定的;在(37±2)℃和(25±2)℃条件存放的加速稳定性表明合格的疫苗分别最多能存放2周和1个月。

Stability of 23-valent pneumococcal polysaccharide vaccine

Objective:To investigate the stability of 23-valent pneumococcal polysaccharide vaccine stored at 2~8 ℃ for 24,27 months,respectively,and accelerated stability of the vaccine stored at(37±2) ℃ and(25±2) ℃.Methods: 3 batches of vaccine produced in 2008 were selected and stored at 2~8 ℃ for 24,27 months,then carrying out tests including appearance inspection,identity test,polysaccharide content,pH,phenol content,sodium chloride content,sterility test,pyrogen test,test for abnormal toxicity.3 batches of vaccine produced in 2011 were stored at(37±2) ℃ for 1,2,3,4 weeks,respectively,and at(25±2) ℃ for 1,2,3 months respectively,then carrying out tests including appearance inspection,identity test,polysaccharide content,pH,phenol content.Results: Test results of the vaccine stored at 2~8 ℃ for 24 and 27 months were in line with the requirements of quality standards.The vaccine stored at(37±2) ℃ for 3 weeks and(25±2) ℃ for 2 months,the polysaccharide content results showed the individual type of polysaccharide content was substandard,the rest test met the quality standards.Conclusion: The quality of 23-valent pneumococcal polysaccharide vaccine stored at 2~8 ℃ for 24 months was stable.The qualified vaccine could be stored for 2 weeks and 1 month at(37±2) ℃ and(25±2) ℃ at most,respectively.