药品水分测定方法的选择及策略  

Selection and strategy of water determination methods in pharmaceuticals

作　　者：周浩 王慧洁 赵媛媛 王欢 张士博 ZHOU Hao;WANG Huijie;ZHAO Yuanyuan;WANG Huan;ZHANG Shibo(Chia Tai Tianqing Pharmaceutical Co.,Ltd.,Nanjing 211100,China)

机构地区：[1]正大天晴药业集团股份有限公司,南京211100

出　　处：《中国药科大学学报》2022年第1期113-119,共7页Journal of China Pharmaceutical University

摘　　要：水分测试贯穿于药品研发、生产、储存及使用全过程,是药品质量研究的重要内容。选择准确、可靠的测试方法测定水分含量,对于药品的质量控制至关重要。本文介绍了国内外药典水分测试通则和应用实例,结合对供试品结构、溶解性、含水量的分析,综述了药品水分测试方法的选择与研究思路,旨在为水分测试方法的开发和质量标准的制订提供依据。Water content determination is an important aspect of quality research in the whole process of pharmaceutical development,production,storage and use.Therefore,it is significant to develop an accurate and robust method for the determination of water content in the quality control of pharmaceuticals.In this article,the selection and strategy for the study of water determination methods are explained on the basis of general water determination principles and application examples in Chinese and foreign pharmacopoeias,together with the analysis of sample structure,solubility and water content.This article aims to provide basis for the development of moisture testing methods and formulation of proper quality standards for pharmaceuticals.

关 键 词：水分测试方法 药品 供试品结构 溶解性 含水量 

分 类 号：R917[医药卫生—药物分析学]