Comprehensive quality analysis strategy for Qizhi Yishen Capsule based on mass spectrometry profiling and tandem fingerprinting technology.

The Qizhi Yishen Capsule (QYC) is a traditional Chinese medicine (TCM) used for the treatment of patients exhibiting syndromes of both qi and yin deficiency in early diabetic nephropathy. However, due to its relatively recent market introduction, no research has yet been reported on the characterization of its chemical constituents. This study presents a reliable and systematic approach for characterizing the chemical constituents present in QYC, establishing its dual-detector mode fingerprint, and quantifying ten components using ultra-performance liquid chromatography coupled with quadrupole-time-of-flight tandem mass spectrometry (UPLC-Q-TOF-MS/MS) and high-performance liquid chromatography with photodiode array and evaporative light scattering detectors (HPLC-PDA-ELSD). Multivariate analysis was also employed to screen characteristic peaks and identify differences across different production years. A total of 103 compounds, including phenolic acids, alkaloids, flavonoids, quinones, terpenoids, and other phytochemicals, were successfully characterized. Moreover, 35 common peaks were matched in the HPLC-PDA mode and 29 in the HPLC-ELSD mode, among which 12 and 6 peaks were identified, respectively. Subsequently, the contents of sinomenine, calycosin-7-O-glucoside, acteoside, specnuezhenide, isoacteoside, aloe-emodin, rhein, emodin, chrysophanol, and physcion in 19 batch samples were determined, ranging from 9.516 to 17.571 mg/g, 0.485 to 0.811 mg/g, 0.853 to 1.750 mg/g, 11.037 to 17.834 mg/g, 1.575 to 11.522 mg/g, 0.342 to 0.664 mg/g, 0.729 to 0.962 mg/g, 0.318 to 0.566 mg/g, 0.835 to 1.391 mg/g, and 0.424 to 0.727 mg/g, respectively. Overall, the findings of this study may support future investigations into the active chemical constituents and quality evaluation of QYC.