各国制药用水分类研究进展  

Study on classification of water for pharmaceutical in different countries

作　　者：郑洁 吴兆伟 安京烨 朱晓月 吴斌 张喆 胡琴 王琳 ZHENG Jie;WU Zhao-wei;AN Jing-ye;ZHU Xiao-yue;WU Bin;ZHANG Zhe;HU Qin;WANG Lin(NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing Institute for Drug Control,Beijing 102206,China)

机构地区：[1]北京市药品检验研究院,国家药品监督管理局仿制药研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《中国新药杂志》2024年第6期564-568,共5页Chinese Journal of New Drugs

摘　　要：制药用水在药品生产中用量大、应用广,其质量直接影响患者的用药安全。本文概述比较了中国、美国、日本和欧盟对制药用水的分类,分析了各国家/地区制药用水分类制法和应用范围的差异,探讨了我国制药用水分类合理性并提出建议,为加强我国制药用水质量控制及科学监管提供参考。The water for pharmaceutical is vastly and widely used in pharmaceutical production,and its quality directly affects the safety of patients.This paper summarizes and compares the classifications of water for pharmaceuticals and analyzes the differences of the classification and application of water for pharmaceuticals in China,USA,Japan and European Union.In addition,it probes into the rationale of the classification and provides suggestions to strengthen the quality control and scientific supervision of water for pharmaceuticals in our country.

关 键 词：制药用水 中华人民共和国药典 美国药典 欧洲药典 日本药局方 质量控制 

分 类 号：R921.3[医药卫生—药学]