疫苗研究

疫苗0~2 ℃储存挑战性实验

  • 罗静 ,
  • 南方 ,
  • 赵田 ,
  • 周扬 ,
  • 彭维 ,
  • 吕雪艳
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  • 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 6100232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 6100233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 6100234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 ℃

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  • 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)

摘要

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02 ℃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02 ℃条件下一定时间后,与存放于28 ℃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02 ℃条件下分别存放17 h 20 min18 h 55 min,病毒滴度均符合5.77.1 lgPFU/ml的质量标准,且与存放于28 ℃规定条件的同批次疫苗比较,t值分别为0.260.28P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02 ℃条件下存放21 h 50 min23个型别的多糖含量均符合3565 μg/ml的质量标准,且与存放于28 ℃规定条件的同批次疫苗比较t值为0.01~2.25P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02 ℃条件下的一定时间内,疫苗效价仍符合质量标准。

本文引用格式

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

Abstract

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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