医药导报2026，Vol.45Issue(8)：1344-1349,6.DOI:10.3870/j.issn.1004-0781.2026.08.006
中国、美国、日本、欧盟基于药品说明书的贮藏温度对比研究
Comparative Study of Storage Temperatures Based on Drug Package Inserts in China,the United States,Japan,and the European Union
摘要
Abstract
To reveal the impact of differing drug storage standards on drug quality and medication safety,this study systematically compared the similarities and differences in drug storage temperature requirements across four major regulatory systems:China,the United States,Japan,and the European Union.Focusing on drugs available in hospital and community pharmacies,85 products marketed in all four regions requiring non-room temperature storage were identified.Comparative analysis of their labeling conditions(centered on temperature)revealed that 55 drugs(64.7%)had discrepant storage temperature requirements.These differences may be related to factors such as drug stability studies,regulatory standards,climatic environment,packaging materials and manufacturing processes,and clinical application.To enhance global consistency in drug quality management and mitigate risks from storage standard discrepancies,it is recommended to strengthen international cooperation to promote unified storage standards and improve technological capabilities across drug production,transport,and storage to ensure global drug quality,safety,and efficacy.关键词
药品贮藏/贮藏条件/药典/药品说明书Key words
Drug storage/Storage conditions/Pharmacopoeia/Drug package insert分类
医药卫生引用本文复制引用
杨佳钰,闫奕龙,吴汀溪,赵志刚..中国、美国、日本、欧盟基于药品说明书的贮藏温度对比研究[J].医药导报,2026,45(8):1344-1349,6.基金项目
中国药品监督管理研究会立项课题资助项目(2024-Y-Y-005). （2024-Y-Y-005）
