文章摘要
王丽婵,卫辰,骆鹏,徐永革,祖俊,谢春明,严永庆,王志伟,晁哲,吴燕,马霄.第三代百日咳疫苗毒性国家标准品的制备和标定[J].中国药事,2021,35(3):269-273
第三代百日咳疫苗毒性国家标准品的制备和标定
Preparation and Calibration of the Third-Generation National Standard for Toxicity of Pertussis Vaccines
  
DOI：10.16153/j.1002-7777.2021.03.005
中文关键词: 百日咳疫苗  毒性国家标准品  协作标定
英文关键词: pertussis vaccines  national standard for toxicity of pertussis vaccines  collaborative calibration
基金项目:国家科技重大专项重大新药创制(编号 2018ZX09738005)
作者单位
王丽婵 中国食品药品检定研究院,北京 102629 
卫辰 中国食品药品检定研究院,北京 102629 
骆鹏 中国食品药品检定研究院,北京 102629 
徐永革 成都生物制品研究所有限责任公司,成都 610023 
祖俊 武汉生物制品研究所有限责任公司,武汉 430060 
谢春明 北京民海生物科技有限公司,北京 102629 
严永庆 玉溪沃森生物技术有限公司,玉溪 653000 
王志伟 北京科兴中维生物技术有限公司,北京 100085 
晁哲 中国食品药品检定研究院,北京 102629 
吴燕 中国食品药品检定研究院,北京 102629 
马霄 中国食品药品检定研究院,北京 102629 
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中文摘要:
      目的：制备和标定第三代百日咳疫苗毒性国家标准品，用于百日咳疫苗毒性检测。方法：按照 《中国药典》三部(2015 版)的相关要求，选用百日咳疫苗生产菌株CS 株进行发酵罐培养，将收获的百日咳菌液灭活后分装冻干，作为第三代百日咳疫苗毒性国家标准品的候选品。按照《中国药典》三部要求对候选品进行检定，以第二代百日咳疫苗毒性国家标准品为标准，组织6家单位进行协作标定， 并采用热加速试验对候选毒性标准品进行稳定性考察。结果：共制备合格候选毒性标准品7000支，其外观、水分、分装精度均符合《中国药典》的相关要求；协作标定结果经统计学分析，最终确定每支第三代毒性标准品LPU 为60，HSU 为84；且稳定性良好。结论：候选毒性标准品各项指标均符合《中国药典》的各项要求，且一致性、稳定性良好，可作为第三代百日咳疫苗毒性国家标准品使用。
英文摘要:
      Objective: To prepare and calibrate the third-generation national standard for toxicity of pertussis vaccines so as to test the toxicity of pertussis vaccines. Methods: The pertussis production strains (CS Strain No. CMCC58003) were fermented and inactivated. After the harvested pertussis liquid was inactivated, subassembled and freeze-dried, it was used as the candidate for the third-generation national standard for toxicity of pertussis vaccines (simplified as candidate). The candidates were tested according to the requirements in Chinese Pharmacopeia (Volume Ⅲ , 2015 edition). The calibration of toxicity for candidate was carried out in six laboratories by using the second-generation national standard for toxicity of pertussis vaccine as standard.The stability of candidate was investigated by heat accelerating test. Results: A total of 7000 ampoules ofqualified candidate were obtained. All the quality indexes of the candidate met the requirements for national standard. The toxicity of candidate was calibrated as 60 LPU and 84 HSU, respectively in one ampoule, and the heat accelerating test showed that the candidate was stable. Conclusion: The candidate could serve as the thirdgeneration national standard for toxicity of pertussis vaccine for toxicity assay.
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