2012～2016年组分百日咳疫苗质量趋势分析及评价Trend analysis and evaluation of quality of component pertussis vaccine during 2012～2016
卫辰;王丽婵;晁哲;侯启明;张路民;吴燕;骆鹏;马霄;
摘要(Abstract)：
目的对我国2012~2016年组分百日咳疫苗的批签发情况进行总结,评价疫苗的总体质量及存在的问题。方法通过资料审查和实验室检定,对121批组分百日咳疫苗按注册标准进行毒性和效价检定,对56批产品按企业放行方法进行免疫原性检定。对检定结果进行统计和质量趋势分析,同时与企业检定结果进行比较,回顾疫苗质量的整体情况。结果毒性和效价结果 100%符合《中国药典》标准,中检院与企业免疫原性检定方法结果差异有统计学意义(P<0.05)。脑腔攻击效价、FHA抗体检定结果出现下降趋势;企业自检PT抗原纯化液CHO簇集活性出现下降趋势。结论组分百日咳疫苗质量稳定,且符合《中国药典》要求,但有缓慢下降趋势。企业检定方法可能无法准确反应产品质量,实施国家批签发和批批检可有效对疫苗生产起到规范及督促作用。
关键词(KeyWords)： 组分百日咳;联合疫苗;质量控制;趋势分析
基金项目(Foundation):
作者(Author): 卫辰;王丽婵;晁哲;侯启明;张路民;吴燕;骆鹏;马霄;
Email:
参考文献(References)：
- [1]WHO.Guidelines for independent lot release of vaccines by regulatory authorities[S/OL].(2010-10-xx)[2017-05-31].http://www.who.int/biologicals/Guidelines_for_Lot_Release_AFTER_ECBS_27.1.2011.pdf.2010.
- [2]刘欣玉,张洁,贾丽丽,等.乙型脑炎减毒活疫苗质量控制中趋势分析的应用[J].中国生物制品学杂志,2012,25(11):1562-1564.
- [3]Chinese Pharmacopoeia Commission.Pharmacopoeia of People's Repubic of China(VolⅢ)[S].Beijing:China Med Sci Press,2015:102-105.(in Chinese)国家药典委员会.中国药典(三部)[S].北京:中国医药科技出版社,2015:102-105.
- [4]MA X,MENG L,TAN Y J,et al.Application of trend analysis method for vaccine lot release[J].Chin Pharm Affa,2014,28(7):750-753.(in Chinese)马霄,孟丽,谭亚军,等.趋势分析在疫苗产品批签发管理中的应用[J].中国药事,2014,28(7):750-753.
- [5]唐静,李亚南,赵丹,等.我国ACYW135群脑膜炎球菌多糖疫苗趋势分析及质量评价[J].中国生物制品学杂志,2015,28(6):657-661.
- [6]ISBRUCKER R,ARCINIEGA J,MCFARLAND R,et al.Report on the international workshop on alternatives to the murine histamine sensitization test(HIST)for acellular pertussis vaccines:state of the science and the path forward[J].Biologicals,2014,42(2):114-122.
- [7]ARCINIEGA J,WAGNER L,PRYMULA R,et al.Alternatives to HIST for acellular pertussis vaccines:progress and challenges in replacement[J].Pharmeur Bio Sci Notes,2016,2015:82-96.
- [8]WAGNER L,ISBRUCKER R,LOCHT C,et al.In search of acceptable alternatives to the murine histamine sensitisation test(HIST):what is possible and practical[J].Pharmeur Bio Sci Notes,2016,2016:151-170.
- [9]XING D,ASOKANATHAN C,XU Y H,et al.Relationship of immunogenicity to protective potency in acellular pertussis vaccines[J].Hum Vaccin Immunother,2014,10(7):2066-2073.
- [10]OH H,JOUNG J,KIM B,et al.Retrospective analysis of the results of acellular pertussis vaccine toxicity tests performed in Korea[J].Hum Vaccin Immunother,2012,8(6):783-787.