Profiling and Characterization of the Constituents of Traditional Chinese Medicine Formula Tongyangxiao Analyzed by Ultra‐High‐Performance Liquid Chromatography‐Q‐Exactive Orbitrap Tandem Mass Spectrometry Method

ABSTRACT Tongyangxiao Lotion is a commonly used traditional Chinese medicine external treatment prescription in clinical practice, which has the effects of anti‐inflammation, pain relief, detumescence, itching relief, and promoting wound healing. By combining pharmacological actions with physical effects, this lotion enables high‐concentration medicinal liquid to act on damaged tissues, facilitating rapid recovery. It is suitable for various anorectal diseases, including mixed hemorrhoids, anal fissure, anal sinusitis, and anal fistula. However, the chemical constituents of Tongyangxiao Lotion remain unclear due to the scarcity of relevant studies, which has hindered the in‐depth research on its pharmacological mechanism and development. In this study, a rapid and efficient comprehensive analytical method for Tongyangxiao Lotion was established for the first time. Ultra‐high‐performance liquid chromatography‐Q‐Exactive Orbitrap tandem mass spectrometry was used to automatically characterize and identify the chemical profile of Tongyangxiao Lotion. The results showed that more than 57 compounds were detected and structurally characterized, including 23 alkaloids, 10 flavonoids, eight coumarins, six phenylpropanoids, four phenolic acids, two phthalides, and four other components. This study explores the pharmacodynamic material basis of Tongyangxiao Lotion for the first time, providing valuable references for its quality control and clinical application.