Comprehensive multicomponent characterization and quality assessment of Shuang‐Huang‐Lian powder injection by UHPLC‐QTOF‐MS and UHPLC‐Q‐Orbitrap‐MS

Rationale

Shuang-Huang-Lian powder injection (SHLPI) is the famous modern traditional Chinese medicine formula preparations (TCMFs) widely applied to treat acute upper respiratory infections. However, SHLPI is an injection extracted from pure Chinese medicine, and many adverse reactions have been reported clinically. Therefore, it is necessary to deeply characterize the chemical composition of SHLPI and quantitatively analyze its potential allergenic components.

Methods

In this study, the samples were analyzed by ion mobility quadrupole time-of-flight mass spectrometer coupled to ultra-high performance liquid chromatography (UHPLC-QTOF-MS) combined with self-built database. Furthermore, the parallel reaction monitoring (PRM) model of ultra-performance liquid chromatography-quadrupole-Orbitrap mass spectrometry (UHPLC-Q-Orbitrap-MS) was used to successfully quantify 10 representative bioactive components.

Results

Through this strategy, a total of 90 compounds identified and the fragmentation pathways of five representative compounds in the five main components of SHLPI were summarized and 10 components (neochlorogenic acid, chlorogenic acid, sweroside, forsythiaside A, luteoloside, isochlorogenic acid B, isochlorogenic acid C, baicalin, phillyrin, baicalein) as the quality markers of SHLPI based on UPLC-Q-Orbitrap-MS.

Conclusions

This work comprehensively characterized the material basis of SHLPI, summarized the cracking laws of representative substances, and quantitatively analyzed 10 potential allergenic components. Therefore, this study could provide a basis for the quality control of SHLPI and the clinical rational use of drugs to reduce its adverse reactions.