A群C群脑膜炎球菌结合疫苗稳定性

Stability of group A and C meningococcal conjugate vaccine

目的：评价A群C群脑膜炎球菌结合疫苗原液和成品的稳定性。方法分别将A群、C群脑膜炎球菌结合疫苗原液及A群C群脑膜炎球菌结合疫苗各选取连续3批，分别放置于37℃、20～25℃和2～8℃3种温度下，在一定的时间取样进行主要项目测定，在关键时间点进行全面检测。结果A群结合疫苗原液于2～8℃保存9个月，20～25℃保存4周，37℃保存4d；C群结合疫苗原液于2～8℃保存9个月，20～25℃保存6个月，37℃保存4周；A群C群脑膜炎球菌结合疫苗于2～8℃保存2年3个月，20～25℃保存6个月，37℃可以保存9周；各项检测指标均符合质量标准的要求。结论在2～8℃条件下，A群、C群脑膜炎球菌结合疫苗原液存放6个月，A群C群脑膜炎球菌结合疫苗存放2年，其质量稳定。

Objective To determine the stability of group A and C meningococcal conjugate vaccine .Methods Each three in consecutive batches of stock solution for group A and C meningococcal polysaccharide preparation and freeze -dried A and C meningococcal polysaccharide conjugate vaccines were stored at 37 ℃, 20-25 ℃, and 2-8 ℃,respectively. A comprehensive test was carried out in a sampling test in detection major items , at the key point in a certain time . Results Stock solution of group A meningococcal conjugate vaccine stored at 2-8 ℃could be preseverved for 9 months, at 20-25 ℃for 4 weeks, at 37℃for 4 days;stock solution of group C meningococcal conjugate vaccines stored at 2-8℃could be preserved for 9 months, at 20-25℃for 6 months, at 37℃for 4 weeks;group A and C meningococcal conjugate vaccine stored at 2-8 ℃could be preserved for two years and three months , at 20-25 ℃ for 6 months, at 37 ℃ for 9 weeks.The tested results all met with requirements of quality control .Conclusion The stock solution for group A and C meningococcal polysaccharide preparation could be preserved for 6 months, and group A and C meningococcal conjugate vaccine for 2 years at 2-8 ℃, it is under such conditions that these preparations are stable .