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20122016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(Authors): 卫辰;王丽婵;晁哲;侯启明;张路民;吴燕;骆鹏;马霄;
DOI: 10.13200/j.cnki.cjb.002110
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