关于预防性人用疫苗企业标准物质的思考  

Reflections on manufacturer's reference materials of preventive human vaccines

作　　者：王一平[1] 赵宗阁[1] 吴星[1,2] 梁争论 毛群颖[1,2] WANG Yiping;ZHAO Zongge;WU Xing;LIANG Zhenglun;MAO Qunying(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室,北京102629

出　　处：《中国生物制品学杂志》2023年第12期1409-1413,1418,共6页Chinese Journal of Biologicals

基　　金：国家科技重大专项(2018ZX09101-001);中国医学科学院医学与健康科技创新工程项目(2021-I2M-5-005)。

摘　　要：疫苗标准物质为疫苗质量控制、剂量确定和有效性评价的标尺。疫苗企业标准物质是各企业在疫苗生产、质控和评价过程中直接使用的工作标准物质,其量值的准确和稳定对保证疫苗产品的批间一致性、安全性和有效性发挥关键作用。本文在调研国内代表性疫苗企业标准物质管理现状的基础上,结合世界卫生组织(World Health Organization,WHO)和《中国药典》等相关指南和法规,提出我国预防性人用疫苗企业标准物质建立和应用时应考虑的要点,并建议制定疫苗企业标准物质指导原则,以规范该类标准物质的研制和应用。Reference materials for vaccine are the standard rulers for quality control,dose determination and effectiveness evaluation of vaccines.Manufacturer's reference materials are a kind of the working standards that are directly used by vaccine enterprises in the process of production,quality control and evaluation,of which the accuracy and stability play a key role in ensuring the consistency between batches,safety and effectiveness of vaccines.Based on the investigation into the current management situation of manufacturer's reference materials in domestic representative vaccine enterprises,and combined with the relevant guidelines and regulations such as World Health Organization guidelines and Chinese Pharmacopoeia,this paper put forward the key points that should be considered in the establishment and application of manufacturer's reference materials of preventive human vaccines.It is also suggested to formulate the guidelines about manufacturer's reference materials in order to regulate the development and application of working reference materials.

关 键 词：疫苗 标准品 参考品 工作标准物质 

分 类 号：R194[医药卫生—卫生事业管理]