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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 23P pneumococcal polysaccharide vaccine stored at 2 ~ 8 ℃ for 24,27 months and the accelerated stability stored at (37 ± 2) ℃ and (25 ± 2) ℃. Methods: The three batches of 23-valent pneumococcal polysaccharide vaccine produced in 2008 were stored at 2-8 ℃ for 24 and 27 months for visual inspection, identification test, polysaccharide content, pH value, phenol content, sodium chloride content, (37 ± 2) ℃ for 1, 2, 3, 4 weeks and at (25 ± 2) ℃, respectively After being stored for 1, 2 and 3 months respectively, identification test, polysaccharide content determination, appearance inspection, pH value and phenol content determination were carried out. Results: The vaccine was stored at 2 to 8 ℃ for 24 and 27 months. The test results were in accordance with the quality standards. The vaccine was stored at 37 ± 2 ℃ and (25 ± 2) ℃ from the third week and the second month respectively, Individual types of polysaccharide content below the quality standards, the remaining indicators are in line with quality standards for testing the requirements. CONCLUSION: The 23-valent pneumococcal polysaccharide vaccine is stable in shelf-life at 2-8 ° C until expiration of 24 months; the accelerated stability stored at (37 ± 2) ° C and (25 ± 2) ° C indicates acceptable vaccine Can be stored for up to 2 weeks and 1 month respectively.