CAJ | 학술논문

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4 d；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。
목적：평개A군C군뇌막염구균결합역묘원액화성품적은정성。방법분별장A군、C군뇌막염구균결합역묘원액급A군C군뇌막염구균결합역묘각선취련속3비，분별방치우37℃、20～25℃화2～8℃3충온도하，재일정적시간취양진행주요항목측정，재관건시간점진행전면검측。결과 A군결합역묘원액우2～8℃보존9개월，20～25℃보존4주，37℃보존4 d；C군결합역묘원액우2～8℃보존9개월，20～25℃보존6개월，37℃보존4주；A군C군뇌막염구균결합역묘우2～8℃보존2년3개월，20～25℃보존6개월，37℃가이보존9주；각항검측지표균부합질량표준적요구。결론재2～8℃조건하，A군、C군뇌막염구균결합역묘원액존방6개월，A군C군뇌막염구균결합역묘존방2년，기질량은정。
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 .