1成都生物制品研究所有限责任公司质量保证部、四川省疫苗工程技术研究中心,成都 610023;2成都生物制品研究所有限责任公司质量运营部、四川省疫苗工程技术研究中心,成都 610023;3成都生物制品研究所有限责任公司、四川省疫苗工程技术研究中心,成都 610023;4成都生物制品研究所有限责任公司质量检定室、四川省疫苗工程技术研究中心,成都 610023
网络出版日期: 2025-08-16
基金资助
国家科技重大专项“重大新药创制”(2016ZX09101091)
Challenging experiment on vaccine storage environment at 0-2 ℃
1Quality Assurance Department, Chengdu Institute of Biological Products Co., Ltd., Sichuan Vaccine Engineering Technology Research Center, Chengdu 610023, China; 2Quality Compliance Management Department, Chengdu Institute of Biological Products Co., Ltd., Sichuan Vaccine Engineering Technology Research Center, Chengdu 610023, China; 3Chengdu Institute of Biological Products Co., Ltd., Sichuan Vaccine Engineering Technology Research Center, Chengdu 610023, China; 4Quality Control Department, Chengdu Institute of Biological Products Co., Ltd., Sichuan Vaccine Engineering Technology Research Center, Chengdu 610023, China
Online published: 2025-08-16
Supported by
National Science and Technology Major Project of China for“Major New Drug Innovation and Development”(2016ZX09101091)
目的 探讨冻干制剂乙型脑炎减毒活疫苗和液体制剂23价肺炎球菌多糖疫苗0~2 ℃条件下存放对其效价的影响。方法 将冻干制剂乙型脑炎减毒活疫苗和液体制剂23价肺炎球菌多糖疫苗存放于0~2 ℃条件下一定时间后,与存放于2~8 ℃规定条件的制品进行疫苗效价的比较。结果 1人份和5人份乙型脑炎减毒活疫苗在0~2 ℃条件下分别存放17 h 20 min和18 h 55 min,病毒滴度均符合5.7~7.1 lgPFU/ml的质量标准,且与存放于2~8 ℃规定条件的同批次疫苗比较,t值分别为0.26和0.28,P值均大于0.05,差异无统计学意义;23价肺炎球菌多糖疫苗在0~2 ℃条件下存放21 h 50 min,23个型别的多糖含量均符合35~65 μg/ml的质量标准,且与存放于2~8 ℃规定条件的同批次疫苗比较,t值为0.01~2.25,P值均大于0.05,差异无统计学意义。结论 冻干制剂乙型脑炎减毒活疫苗和液体制剂23价肺炎球菌多糖疫苗存放在0~2 ℃条件下的一定时间内,疫苗效价仍符合质量标准。
罗静 , 南方 , 赵田 , 周扬 , 彭维 , 吕雪艳 . 疫苗0~2 ℃储存挑战性实验[J]. 国际生物制品学杂志, 2022 , 45(5) : 247 -250 . DOI: 10.3760/cma.j.cn311962-20211215-00086
Objective To investigate the effect on their potencies of lyophilized live attenuated Japanese encephalitis vaccine and liquid 23-valent pneumococcal polysaccharide vaccine when stored at 0-2 ℃. Methods The potencies of lyophilized live attenuated Japanese encephalitis vaccine and liquid 23-valent pneumococcal polysaccharide vaccine stored at 0-2 ℃ after certain time were compared with same batch vaccines stored at 2-8 ℃. Results Lyophilized live attenuated Japanese encephalitis vaccines of 1-dose and 5-dose were stored at 0-2 ℃ for 17 h 20 min and 18 h 55 min,respectively. The viral titers of 1-dose and 5-dose vaccines both met the quality standard of 5.7-7.1 lgPFU/ml, and the t values between titers of the same batch vaccines stored at 0-2 ℃ and 2-8 ℃ were 0.26 and 0.28, respectively, with P values > 0.05, and there was no statistically significant difference. The 23-valent pneumococcal polysaccharide vaccine was stored at 0-2 ℃ for 21 h 50 min. The polysaccharide contents of all 23 types met the quality standard of 35-65 μg/ml, and the t values between polysaccharide contents of the same batch vaccines stored at 0-2 ℃ and 2-8 ℃ were 0.01-2.25 with P value > 0.05, and there was no statistically significant difference. Conclusion The potencies of lyophilized live attenuated Japanese encephalitis vaccine and liquid 23-valent pneumococcal polysaccharide vaccine still meet the quality standard after store at 0-2 ℃ for a certain time.
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