放射性药品的放化纯度分析方法概述  

A Review on Radiochemical Purity Analysis Methods of Radiopharmaceuticals

作　　者：张云 杨柳 姜华 ZHANG Yun;YANG Liu;JIANG Hua(HTA Co.,Ltd.,Beijing 102413,China)

机构地区：[1]原子高科股份有限公司,北京102413

出　　处：《同位素》2021年第3期221-229,共9页Journal of Isotopes

摘　　要：放化纯度是衡量放射性药品质量的重要指标之一,直接影响临床使用的效果,选择合适的分析方法对其进行准确测定至关重要。本文通过对比《中国药典》2020年版、《欧洲药典》10.2版和《美国药典》43-NF38版收录的放射性检定相关指导原则、放射性药品质量标准,以及相关文献资料,对常用的放化纯度测定方法包括薄层色谱法(TLC)、纸色谱法(PC)、电泳法(EP)、高效液相色谱法(HPLC)的特点、分离原理,以及应用进行分析总结,可为建立更科学、合理的放射性药物质量标准提供技术参考。Radiopharmaceuticals means radionuclide preparations or labeled compounds for clinical diagnosis or therapeutic use.Radiochemical purity is one of the important judgment indexes to measure the quality of radiopharmaceuticals,which directly affects the clinical effect,it is very important to accurately determine and strictly control the radiochemical purity.In this paper,by querying and analyzing Chinese Pharmacopoeia 2020,European Pharmacopoeia 10.2,US Pharmacopoeia 43-NF38,and the related literature,making a analysis and summary on the characteristics,separation principle and application of commonly used radiochemical purity determination methods,including thin-layer chromatography(TLC),paper chromatography(PC),electrophoresis(EP)and high performance liquid chromatography(HPLC),which would help to establish a more scientific and reasonable standard of radiopharmaceuticals quality standards and to provide technical reference.

关 键 词：放射性药品 放化纯度 薄层色谱法 纸色谱法 高效液相色谱法 

分 类 号：TL923[核科学技术—核燃料循环与材料]