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

作　　者：王丽婵 卫辰[1] 骆鹏[1] 徐永革[2] 祖俊 谢春明 严永庆 王志伟 晁哲[1] 吴燕[1] 马霄[1] Wang Lichan;Wei Chen;Luo Peng;Xu Yongge;Zu Jun;Xie Chunming;Yan Yongqing;Wang Zhiwei;Chao Zhe;Wu Yan;Ma Xiao(National Institutes for Food and Drug Control,Beijing 102629,China;Chengdu Institute of Biological Products Co.Ltd.,Chengdu 610023,China;Wuhan Institute of Biological Products Co.Ltd.,Wuhan 430060,China;Minhai Biotechnology Co.Ltd.,Beijingl02629,China;Yuxi Wosen Biological Technology Co.Ltd.,Yuxi 653000,China;Sinovac Research&Development Co.Ltd.,Beijing 100085,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]成都生物制品研究所有限责任公司,成都610023 [3]武汉生物制品研究所有限责任公司,武汉430060 [4]北京民海生物科技有限公司,北京102629 [5]玉溪沃森生物技术有限公司,玉溪653000 [6]北京科兴中维生物技术有限公司,北京100085

出　　处：《中国药事》2021年第3期269-273,共5页Chinese Pharmaceutical Affairs

基　　金：国家科技重大专项重大新药创制(编号2018ZX09738005)。

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。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(VolumeⅢ,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 of qualified 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.

关 键 词：百日咳疫苗 毒性国家标准品 协作标定 

分 类 号：R392-33[医药卫生—免疫学] R95[医药卫生—基础医学]