摘要
目的:探讨23价肺炎球菌多糖疫苗质量控制标准。方法:对《中国药典》三部(2020年版)、《欧洲药典》(European Pharmacopoeia,EP)10.0、《美国药典》(United States Pharmacopoeia,USP)和WHO指南(Recommendations to assure the quality,safety and efficacy of pneumococcal conjugate vaccines,Annex 3.)中的23价肺炎球菌多糖疫苗质量标准进行比较研究。结果:《中国药典》2020年版三部23价肺炎球菌多糖疫苗质量标准比较全面,方法可行、适用。结论:《中国药典》2020年版三部中关于23价肺炎球菌多糖疫苗质量标准适用于该疫苗工艺的质量控制。
Objective:To explore the quality control standard of 23-valent pneumococcal polysaccharide vaccine.Methods:The quality standards of 23-valent pneumococcal polysaccharide vaccine from the Chinese Pharmacopoeia 2020 VolumeⅢ,European Pharmacopoeia(EP)10.0,the United States Pharmacopoeia(USP)and WHO guidelines(recommendations to assure the quality,safety and efficiency of pneumococcal conjugate vaccines,Annex 3.)were compared.Results:The quality standard of 23 valent pneumococcal polysaccharide vaccine from the Chinese Pharmacopoeia 2020 VolumeⅢwas relatively comprehensive,and the test method was feasible.Conclusion:The standard was suitable for the quality control of production procedure for 23-valent pneumococcal polysaccharide vaccine.
作者
陈琼
石继春
王春娥
王珊珊
叶强
CHEN Qiong;SHI Jichun;WANG Chun′e;WANG Shanshan;YE Qiang(Division of Bacterial Polysaccharide and Conjugate Vaccines,Institute for Biological Product Control,National Institutes for Food and Drug Control,National Center for Medical Culture Collections,NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,NMPA Key Laboratory for Quality Research and Evaluation of Biological Products,Beijing 102629,China)
出处
《中国药品标准》
CAS
2022年第2期156-160,共5页
Drug Standards of China
基金
国家科技重大专项课题(2018ZX09738006-006)。
关键词
23价肺炎球菌多糖疫苗
质量标准
质量控制
23-valent pneumococcal polysaccharide vaccine
quality standard
quality control
