《中国药典》2020年版中药材检测溶剂使用情况分析  

Analysis of solvent usage in test of the Chinese materia medica for the Chinese Pharmacopoeia 2020

作　　者：鲁静[1] 翟为民[2] LU Jing;ZHAI Weimin(National Institutes for Food and Drug Control,Beijing 100050,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]中国食品药品检定研究院,北京100050 [2]国家药典委员会,北京100061

出　　处：《中国药品标准》2021年第5期403-406,共4页Drug Standards of China

摘　　要：目的:通过分析《中国药典》2020年版一部中药材检测项目中有机溶剂的使用情况,对药品标准的绿色化发展提出建议。方法:对《中国药典》2020年版一部中药材品种项下薄层色谱鉴别和含量测定项供试品溶液制备中有机溶剂使用量≥50 mL、高效液相色谱方法流动相比例或梯度洗脱的初始比例中有机相≥50%的项目进行检索、筛选和分析。结果与结论:药典部分中药材检验项目中有机溶剂的使用量较大,有必要采用微型化或其它绿色分析化学的替代方法,以减少分析检测对环境与安全的影响和危害。Objective:To put forward some suggestions on the green development of drug standards through analysis of organic solvents usage in the test items of the Chinese Materia Medica in the Chinese Pharmacopoeia 2020,VolⅠ.Methods:The organic solvents with the use volume not less than 50mL in the test solution preparation of thin-layer chromatographic identification and assay,or not less than 50%in the isocratic organic phase or the initial proportion of gradient elution in mobile phase of HPLC were searched,screened and analyzed.Results and Conclusion:The use volume of organic solvents is large in part of the items of the Chinese Pharmacopoeia.It is necessary to adopt miniaturization or other alternative methods of green analytical chemistry,to reduce the impact and harm on the environment and safety.

关 键 词：中国药典 中药材 有机溶剂 绿色分析化学 

分 类 号：R921.2[医药卫生—药学]