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.
Abstract
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.
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