Study on Quality Evaluation of Yangyin Shengji Enteric Capsules Based on HPLC Fingerprinting Combined with Multi-indicator Content Determination
10.19879/j.cnki.1005-5304.202312229
- VernacularTitle:HPLC指纹图谱结合多指标含量测定的养阴生肌肠溶胶囊质量评价研究
- Author:
Yongxia WANG
1
;
Xiaoshuan LIU
;
Jiwen LI
;
Jinyan DOU
Author Information
1. 甘肃中医药大学药学院,甘肃 兰州 730000
- Keywords:
Yangyin Shengji Enteric Capsules;
fingerprint;
HPLC;
content determination
- From:
Chinese Journal of Information on Traditional Chinese Medicine
2024;31(6):130-135
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish the HPLC fingerprint of Yangyin Shengji Enteric Capsules;To determine the contents of gentiopicrin,albiflorin,paeoniflorin,liquiritin,berberine hydrochloride,evodiamine and rutecarpine;To provide a reference for the quality control.Methods The formula medicine was hydrolyzed and ethanol precipitated according to the preparation process.The capsule contents were dissolved in 70%methanol for sample preparation and analyzed on an Agilent 5 HC-C18(2)chromatographic column(250 mm×4.6 mm,5 μm);the mobile phase was acetonitrile-0.1%aqueous phosphoric acid,with gradient elution;the flow rate was 1.0 mL/min;the column temperature was 30℃;and the detection wavelength was 230 nm.The results were analyzed by clustering analysis,similarity evaluation and principal component analysis(PCA)using OriginPro 2021,Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System(2012 edition),SIMCA 14.1 software and SPSS 25.0 statistical software.Results The HPLC fingerprints of Yangyin Shengji Enteric Capsules and the method of simultaneous determination of 7 active components were established.The fingerprints of 13 batches of samples were calibrated with 25 common peaks with good similarity(r≥0.994);Clustering analysis and PCA classified the 13 batches of samples into 2 categories.The 7 ingredients had good linear relationships in their respective ranges(r≥0.999 1);the recoveries ranged from 95.77%to 103.80%with the RSD values of 1.0%to 2.5%.Conclusion The established HPLC fingerprinting and content determination analytical methods are simple,reliable and reproducible,which can provide a basis for comprehensive and effective control of the quality of Yangyin Shengji Enteric Capsules.
