中国现代中药2017，Vol.19Issue(4)：500-503,517,5.DOI:10.13313/j.issn.1673-4890.2017.4.006
款冬花欧盟质量标准研究
Research on Quality Standard of Farfarae Flos for EP Monograph
摘要
Abstract
Objective:To establish the quality standard of Farfarae Flos mainly including TLC method and HPLC determination method,according to the technical guide for the elaboration of EP monographs.Methods:Tussilagone was selected as the marker constituent in the TLC identification method.After developing with cyclohexane-ethyl acetate(4∶1),the plate was sprayed with alcoholic solution of sulfuric acid Reagent and heated,and then examined under 365 nm UV light.In the HPLC determination method,a YMC-Pack ODS-A chromatographic column was used for the separation,with the mobile phase of methanol-water in a gradient elution procedure.The column temperature was set at 35 ℃,the flow rate was set as 0.8 mL·min-1 and the wavelength was set at 220 nm.Results:The TLC identification method was established with good specificity,and the fluorescent zone of tussilagone was clearly detected with high distinguishing degree.Results:of HPLC method validation showedthat the determination method kept good linearity(r =0.999 9)in the concentration range of 3.074-153.7 μg·mL-1 for tussilagone.The average recovery was 99.9％ (RSD =2.0％),RSDs of repeatability,intermediate precision,stability and robustness test were no more than 2.0％.Conclusion:In this paper,a sensitive TLC identification method and an accurate HPLC determination method were established for the quality control of Farfarae Flos,which provided useful research data for EP monograph.关键词
款冬花/欧洲药典/款冬酮/薄层鉴别/含量测定Key words
Farfarae Flos/European Pharmacopeia/tussilagone/TLC identification/determination引用本文复制引用
相婷,吴丽真,郑璐,周海燕..款冬花欧盟质量标准研究[J].中国现代中药,2017,19(4):500-503,517,5.基金项目
国家中医药管理局中医药行业科研专项(201307002) （201307002）
