Quality Markers of Fufang Shenqi Oral Liquid Based on Integrated Fingerprint Analysis, Chemical Pattern Recognition, and Quantification.

Abstract

Introduction: Fufang Shenqi Oral Liquid (FFSQOL) is an important Chinese medicine compound preparation with a wide range of clinical applications, which is mainly used to regulate immune function, improve cardiovascular function, and have anti-inflammatory and antibacterial effects. At present, it is of great importance to establish the quality evaluation method of FFSQOL and to investigate its quality markers (Q-markers).

Objectives: The aim of this study is to establish a quality evaluation method for FFSQOL and screen its Q-markers to provide a scientific basis for its quality control.

Methods: Fourteen batches of FFSQOL were subjected to high-performance liquid chromatography (HPLC) fingerprint and similarity analysis. The components of FFSQOL were identified, and their content was determined. This was combined with cluster analysis (CA) and principal component analysis (PCA) to determine the Q-markers of FFSQOL.

Results: In this study, an HPLC fingerprint was established for 14 batches of FFSQOL, identifying 12 common peaks and six major components. Four components were identified as stable and reproducible: gallic acid (504.94 ~ 1219.04 μg/mL), caffeic acid (452.15 ~ 783.01 μg/mL), 7-O-glucoside (1097.72 ~ 2440.41 μg/mL), and formononetin (176.2 ~ 177.51 μg/mL). Quality evaluation of the 14 batches was conducted using chemical pattern recognition analysis. CA results indicated two distinct groups, and PCA revealed that principal components 1 and 2 were the main factors influencing batch differences. A combination of HPLC fingerprint, content determination results, and chemical pattern recognition analysis was employed to identify Q-markers for FFSQOL. The markers identified were gallic acid, caffeic acid, calycosin 7-O-glucoside, and formononetin.

Conclusion: In this study, a quality evaluation method for FFSQOL was established through the implementation of fingerprint, content determination, and chemical pattern recognition analysis, resulting in the identification of four Q-Markers of FFSQOL, which laid the foundation for the formulation of FFSQOL quality standards.