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11 d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 ℃最多可保存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.