[关键词]
[摘要]
制药用水广泛用于药品生产过程和药物制剂的制备,同时也被用作溶剂、冲洗剂等。制药用水的质量直接影响药品的质量,与药品的安全息息相关。概述分析了中国、美国和欧盟制药用水的管理、质量控制要求及其差异,同时探讨了制药用水分类、注射用水制法及制药用水微生物控制,为国内制药用水相关技术标准建设及科学监管提供参考。
[Key word]
[Abstract]
Water for pharmaceutical use is widely uesd in the processing and manufacture of pharmaceutical products, but also used as solvent, washing agent, etc. Based on the impact of water for pharmaceutical use on drug safety, this issue discuss the differences between different countries about the quality control of water for pharmaceutical use and the classification of medicinal water, preparation of water for injection and microbial control of pharmaceutical water, which provide reference to establish technical standards and satisfied the current quality control for scientific supervision.
[中图分类号]
R951
[基金项目]