Integrating Study on Qualitative and Quantitative Characterization of the Major Constituents in Shuanghuanglian Injection with UHPLC/Q-Orbitrap-MS and UPLC-PDA.

As a clinically effective traditional Chinese medicine injection (TCMI), Shuanghuanglian injection (SHLI) is widely used in the treatment of upper respiratory tract infection and pneumonia. However, the shortage of quality analysis is a limitation that remains to be improved in the clinical application of SHLI. In this study, taking advantage of ultra-high-performance liquid chromatography tandem Q-Exactive Orbitrap high-resolution mass spectrometry (UHPLC/Q-Orbitrap-MS), 31 chemical components (eight organic acids, eleven flavonoids, five iridoid glycosides, four phenylethanoid glycosides, and three lignans) in SHLI were characterized, among which 22 components were unambiguously identified by reference compounds. The brief prediction results of network pharmacology indicated that the 22 targeted components may have anti-inflammatory, antibacterial, antiviral, and immunomodulatory activities. Using multiwavelength switching method, the 22 targeted components were quantified by ultra-performance liquid chromatography with photodiode array detector (UPLC-PDA) after the methodological validation. Based on the successfully established method, the total content of 22 components in 20 batches of SHLIs was efficiently determined with a slight variation between 10.25 and 11.28 mg/mL, which accounted for 38.7% in total solid of SHLI. This study performed a reliable chemical identification and provided a rapid and effective method for quality analysis, which contributed to the in-depth investigation and application of SHLI.