Quality Assessment of Gegen Zhitong Mixture Based on Chemical Fingerprints Combined with Quantitative Analysis of Multi‐Components with a Single‐Marker

ABSTRACT Traditional Chinese medicine (TCM) formulas were one of the most important treasures in TCMs. Gegen Zhitong mixture (GGZTM) was a Chinese medicine preparation (CMP) developed by Wuhan No.1 Hospital according to a TCM formula. The comprehensive quality assessment of CMPs is necessary to ensure their safe and effective use for medical purposes. However, the existing quality evaluation of GGZTM was limited to the content determination of a single marker compound, making it difficult to fully monitor its overall quality. Therefore, an approach that profiled a comprehensive chemical description of GGZTM based on high‐performance liquid chromatography was developed for the first time, and the characteristic common peaks of GGZTM were identified in the present study. Secondly, a quantitative analysis of multi‐components with a single‐marker (QASM) was developed, which could be employed to simultaneously determine the content of three components in GGZTM. Finally, the laboratory prepared a self‐made GGZTM according to the prescription composition and systematically compared it with the GGZTM through similarity analysis and hierarchical cluster analysis based on chemical fingerprints and the content of intrinsic marker components. In conclusion, the developed method is accurate and stable and can be applied to quality control in the production process of GGZTM.