Comprehensive quality evaluation of Qizhi Yishen Capsules through integrated chromatographic fingerprint and multi-marker component quantitation
LI Yuan
LI Qiang
FENG Li
SUN Junying
Abstract：Objective To develop a high-performance liquid chromatography(HPLC)method for fingerprint and sim-ultaneously determining the content of 11 components(chlorogenic acid,calycosin-7-O-β-D-glucoside,verbascoside,specnuezhenide,hyperoside,ononin,aloe-emodin,rhein,emodin,chrysophanol,and physcion)in Qizhi Yishen Capsules(QYC).Methods A Welch Ultimate® XB C18 column(4.6 mm × 250 mum,5 μm)was employed for separation,using a methanol/0.1％phosphoric acid gradient elution system at a flow rate of 1.0 mL·min-1.Detection was carried out at 248 nm,and the column was kept at 25 ℃.The Traditional Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System(Version 2012)was employed to automatically generate a reference fingerprint and determine the content of 11 com-mon components.Results The similarity of the fingerprints exceeded 0.9,and the resolution of all chromatographic peaks was greater than 1.0.A total of 20 common peaks were identified,with 11 peaks confirmed by comparison with reference standards.The linear relationships between peak area and injection amount for the 11 components were satisfactory(r＞0.990),with RSD≤2％and average recoveries exceeding 98％.Conclusion The established method demonstrates good re-producibility,high stability,and accuracy,and can serve as a reference for quality control of QYC.
Keywords：Qizhi Yishen CapsulesFingerprintContent determinationQuality evaluation
Publication Date：2025-09-30
Online Publishing Date：2025-10-30(First online date of this platform, not the publication date of the document)
Pages：5( 869-873 )