摘要
目的探究口服轮状病毒活疫苗在高温保存和冻融后的病毒滴度变化趋势.方法选取2022年生产的3批口服轮状病毒活疫苗,于37℃放置0、7、9、11和14 d或-20℃-室温冻融0、1、2、3、4、5次,进行病毒滴度检测;选取2022年生产的5批口服轮状病毒活疫苗原液,于37℃放置0、3、5、7、9和11d或-20℃-室温冻融0、1、2、3、4、5次,进行病毒滴度检测.结果口服轮状病毒活疫苗于37℃保存9 d时病毒滴度大于5.5 lgCCID50/ml;口服轮状病毒活疫苗原液于37℃保存9 d时病毒滴度不低于5.5 lgCCID50/ml;口服轮状病毒活疫苗5次冻融,病毒滴度不低于5.8 lgCCID50/ml;口服轮状病毒活疫苗原液5次冻融,病毒滴度不低于6.0 lgCCID50/ml;均符合质量标准.第1次冻融后口服轮状病毒活疫苗滴度明显降低,但不大于1 lg,后续4次反复冻融对滴度未产生明显影响.结论口服轮状病毒活疫苗在37℃可保存9 d,5次冻融后滴度仍符合质量标准.
Objective To analyze the viral titer changing trend of Oral Rotavirus(Live)Vaccine(ORV)under high temperature storage and freeze-thawing.Methods Three batches of ORV produced in 2022 were selected and placed at 37℃for 0,7,9,11,and 14 d,or frozen-thawed between-20℃and room temperature for 0,1,2,3,4 and 5 times,then tested for viral titer.Five batches of ORV bulks produced in 2022 were selected and placed at 37℃for 0,3,5,7,9 and 11 d,or frozen-thawed between-20℃and room temperature for 0,1,2,3,4 and 5 times,then tested for viral titer.Results After stored at 37℃for 9 d,the viral titers of ORV were>5.5 lgCCID50/ml and those of vaccine bulks were≥5.5 lgCCID50/ml,and still met the quality standard.ORV and bulks were repeatedly frozen-thawed for 5 times,and their virus titers(≥5.8 lgCCID50/ml and≥6.0 lgCCID50/ml,respectively)met the quality standards.The titer of ORV was significantly decreased after the first freeze-thawing,but not more than 1 lg,and was not significantly affected by the following 4 repeated freeze-thaw cycles.Conclusions ORV can be stored at 37℃for up to 9 d.Repeated freeze-thawing does not draw the titer of ORV below the quality standard.
作者
石岩
刘晓凡
刘军
马希强
陈刚
张丽君
Shi Yan;Liu Xiaofan;Liu Jun;Ma Xiqiang;Chen Gang;Zhang Lijun(Quality Assurance Department,Lanzhou Institute of Biological Products Co.,Ltd.,Lanzhou 730046,China;Quality Control Department,Lanzhou Institute of Biological Products Co.,Ltd.,Lanzhou 730046,China)
出处
《国际生物制品学杂志》
CAS
2024年第1期7-10,共4页
International Journal of Biologicals
关键词
轮状病毒疫苗
稳定性
冻融
高温
Rotavirus vaccine
Stability
Freezing and thawing
High temperature
作者简介
通信作者:张丽君,Email:hi_zhanglijun@126.com。
