23价肺炎球菌多糖疫苗稳定性考察

Stability of 23-valent pneumococcal polysaccharide vaccine

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。

Objective ：To investigate the stability of 23-vaient 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 polysaceharide 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.