中国、美国、日本、欧盟基于药品说明书的贮藏温度对比研究OA
Comparative Study of Storage Temperatures Based on Drug Package Inserts in China,the United States,Japan,and the European Union
为揭示药品贮藏标准差异对药品质量与用药安全的影响,该研究系统对比了中国、美国、日本及欧盟四大监管体系中,药品贮藏温度要求的异同.以医院药房与社会药店的药品为对象,筛选出在四个监管区域均已上市、且非常温贮藏、对温度有特殊要求的药品共 85 种.通过对其说明书贮藏条件(以温度为核心)的对比分析,发现其中 55 种(64.7%)药品的贮藏温度要求存在区间差异.这些差异可能与药品稳定性研究、法规标准、气候环境、包装材料与生产工艺、临床现实应用等因素相关.为提高药品质量管理的全球一致性,降低贮藏标准差异带来的风险,建议加强国际合作,推动贮藏标准的统一化,同时提升药品生产、运输、存储各环节的技术水平,保障药品在全球范围内的质量、安全性和有效性.
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.
杨佳钰;闫奕龙;吴汀溪;赵志刚
首都医科大学附属北京天坛医院药学部,北京 100070||浙江省肿瘤医院药剂科,杭州 310022首都医科大学附属北京天坛医院药学部,北京 100070||中国医学科学院北京协和医院药剂科,北京 100730首都医科大学附属北京天坛医院药学部,北京 100070首都医科大学附属北京天坛医院药学部,北京 100070
医药卫生
药品贮藏贮藏条件药典药品说明书
Drug storageStorage conditionsPharmacopoeiaDrug package insert
《医药导报》 2026 (8)
1344-1349,6
中国药品监督管理研究会立项课题资助项目(2024-Y-Y-005).
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