基于多成分定量及薄层鉴别评价金匮肾气丸的质量  

Quality evaluation of Jinkui Shenqi Pills based on multi-component quantification and thin-layer chromatographic identification

作　　者：马光宇[1] 李东亮[1] 曹朴琼 MA Guangyu;LI Dongliang;CAO Puqiong(Baoshan College of Traditional Chinese Medicine,Baoshan 678000,China;Baoshan Inspection and Testing Center for Food and Drug,Baoshan 678000,China)

机构地区：[1]保山中医药高等专科学校,保山678000 [2]保山市食品药品检验检测中心,保山678000

出　　处：《西北药学杂志》2024年第4期16-22,共7页Northwest Pharmaceutical Journal

基　　金：云南省教育厅科学研究基金资助性项目(编号:2023J1808):保山中医药高等专科学校科学研究项目(编号:2021K004)。

摘　　要：目的建立同时测定金匮肾气丸(大蜜丸)中5种指标成分含量的方法,为其质量评价提供依据。方法采用高效液相色谱法(high performance liquid chromatography,HPLC)同时测定金匮肾气丸(大蜜丸)中的莫诺苷、马钱苷、桂皮醛、丹皮酚、毛蕊花糖苷5种成分的含量,采用薄层色谱法(thin-layer chromatography,TLC)对地黄、酒萸肉、茯苓和泽泻进行定性鉴别。结果HPLC测定的5个成分分离良好;在各自的线性范围内线性关系良好;精密度、重复性及稳定性实验的相对标准偏差均低于2.0%;平均回收率为93.98%~99.14%。TLC斑点清晰且阴性对照无干扰。结论所建立的定性和定量方法操作简单易行,重复性好,结果精确可靠,能有效提高该制剂的质量控制水平。Objective To establish quality evaluation methods for Jinkui Shenqi Pills(honeyed pills)based on 5 components simultaneous quantification and thin-layer chromatographic(TLC)identification.Methods The contents of the 5 components in Jinkui Shenqi Pills,i.e.,morroniside,loganin,cinnamaldehyde,paeonol,and verbascoside,were determined by high performance liquid chromatography(HPLC).TLC was used to qualitatively identify Rehmannia glutinosa,wine-prepared Fructus corni,Poria cocos and Rhizoma alismatis.Results The 5 components determined by HPLC were well separated.The linear relationship was good in each linear range.The relative standard deviation of precision,repeatability and stability tests were lower than 2.0%.The average recovery was 93.98%-99.14%.TLC spots were clear and the negative controls showed no interference.Conclusion The established qualitative and quantitative methods are simple,reproducible,accurate and reliable,and can effectively improve the quality control level of this preparation.

关 键 词：金匮肾气丸 高效液相色谱 薄层色谱 质量评价 

分 类 号：R284[医药卫生—中药学]