基于多组分分析的痢泻灵片质量标准研究  

Study on the Quality Standard of Lixieling Tablets Based on Multicomponent Analysis

作　　者：于密密 张文婷 张冉 刘萱 陈有根 李铮 傅欣彤 郭洪祝 YU Mimi;ZHANG Wenting;ZHANG Ran;LIU Xuan;CHEN Yougen;LI Zheng;FU Xintong;GUO Hongzhu(Beijing Institute for Drug Control,NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine(Traditional Chinese Patent Medicine),Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,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中成药质量评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《中国现代应用药学》2023年第19期2687-2693,共7页Chinese Journal of Modern Applied Pharmacy

基　　金：2022年国家药品抽检项目。

摘　　要：目的建立痢泻灵片的质量标准。方法采用薄层色谱法对痢泻灵片中拳参、穿心莲、苦参进行定性鉴别;采用HPLC对痢泻灵片中穿心莲类成分和苦参碱类成分进行测定。结果拳参、穿心莲、苦参薄层斑点清晰,分离效果良好,重复性好。穿心莲内酯、新穿心莲内酯、14-去氧穿心莲内酯、脱水穿心莲内酯、苦参碱、氧化苦参碱、槐果碱、氧化槐果碱在各自的浓度范围内线性关系良好,仪器精密度、重复性、稳定性、加样回收率的RSD值均符合要求。结论建立的方法简单易操作,可用于控制痢泻灵片的质量。OBJECTIVE To establish the quality standard of Lixieling tablets.METHODS Thin layer chromatography was used to identify Bistortae Rhizoma,Andrographis Herba and Sophorae Flavescentis Radix in Lixieling tablets.The components of andrographolium and matrine were determined by HPLC.RESULTS The thin layer spots of Bistortae Rhizoma,Andrographis Herba and Sophorae Flavescentis Radix were clear,with good separation effect and repeatability.The linear relationship between andrographolide,neoandrographolide,14-deoxygenated andrographolide,dehydrated andrographolide,sophorine,oxymatrine,sophorine and oxysophorine and their respective concentration ranges was good.The RSDs of instrument precision,repeatability,stability and recovery all met the requirements.CONCLUSION The method is simple and reproducible,and can be used for the quality control of Lixieling tablets.

关 键 词：痢泻灵片 质量标准 一测多评 质量控制 

分 类 号：R284.1[医药卫生—中药学] R917.101[医药卫生—中医学]