天津中医药大学学报2025，Vol.44Issue(6)：495-501,7.DOI:10.11656/j.issn.1673-9043.2025.06.04
清肺合剂薄层色谱鉴别、HPLC指纹图谱及多指标成分质量研究
Quality control of Qingfei Mixture:thin-layer chromatography identification,high-performance liquid chromatography fingerprint development,and multi-component quantification
摘要
Abstract
[Objective]To establish quality control methods for Qingfei mixture,including thin-layer chromatography(TLC)identification,high-performance liquid chromatography(HPLC)fingerprint analysis,and content determination of naringin,neohesperidin,baicalin,and ephedrine hydrochloride.[Methods]TLC was used for qualitative identification of Houttuynia cordata,Indigo naturalis,and Glycyrrhiza uralensis.HPLC analysis was performed on an Agilent Eclipse XDB-C18 column(4.6 mm×250 mm,5 μm)with a gradient elution of acetonitrile and 0.1％aqueous phosphoric acid solution.The column temperature was 30 ℃,with an injection volume of 10 μL,a flow rate of 1.0 mL/min,and a detection wavelength of 280 nm.HPLC fingerprints of 15 batches of Qingfei mixture were established and evaluated using the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(Version A).The contents of four active components were simultaneously determined.[Results]The TLC methods for Houttuynia cordata,Indigo naturalis,and Glycyrrhiza uralensis showed strong specificity without interference.Methodological validation of the HPLC fingerprint and content determination met regulatory requirements.The similarity of fingerprints from different batches reached 0.999.Eighteen common peaks were labeled,and seven components were identified:ephedrine hydrochloride,amygdalin,liquiritin,naringin,neohesperidin,baicalin,and peucedanum praeruptorum A.The average contents of naringin,neohesperidin,baicalin,and ephedrine hydrochloride were 3.517,2.137,6.417,and 0.204 mg/mL,respectively.[Conclusion]The established TLC identification,HPLC fingerprint,and content determination methods are specific,stable,reliable,and practical for comprehensive quality control of Qingfei mixture.关键词
清肺合剂/薄层色谱/高效液相色谱/指纹图谱/有效成分/含量测定Key words
Qingfei Mixture/TLC/HPLC/fingerprint/effective ingredients/content determination分类
医药卫生引用本文复制引用
李宇,樊官伟,刘芳,张美微,陈妤,瞿晶田,陈涛,王洋,范栢爽,柴士伟..清肺合剂薄层色谱鉴别、HPLC指纹图谱及多指标成分质量研究[J].天津中医药大学学报,2025,44(6):495-501,7.基金项目
国家中医药管理局中医药科技研究专项项目. （）
