A Research Strategy to Analyze the Major Chemical Constituents in Kudiezi Injection based on Mass Spectrometry and Chromatographic Techniques.

Kudiezi injection was a commonly used drug in clinical practice, contained many components and was complex in structure. In order to effectively control the quality of traditional Chinese medicine, the study established a systematic research strategy for the first time. Through the UPLC-Q-TOF/MS technology analysis, 35 chemical components in Kudiezi injection were obtained, including four major categories. Moreover, the the quantitative methods of flavonoids by HPLC and organic acids by UPLC-MS/MS were established. A variety of chromatographic techniques, with good precision, sensitivity, repeatability and solution stability were applied to the analysis of 10 batches of Kudiezi injection. Therefore, the quality control of Kudiezi injection was a reliable and effective method, which can provide ideas for the qualitative and quantitative study of chemical constituents in other complex Chinese medicines.