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.

中文翻译：

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基于质谱和色谱技术分析苦地子注射液中主要化学成分的研究策略。

苦地子注射液是临床上常用的药物，含有很多成分，结构复杂。为了有效控制中药质量，本研究首次建立了系统的研究策略。通过UPLC-Q-TOF / MS技术分析，获得了库迪兹注射液中的35种化学成分，包括四个主要类别。建立了HPLC测定黄酮类化合物和UPLC-MS / MS测定有机酸的定量方法。采用多种色谱技术，具有良好的精密度，灵敏度，重复性和溶液稳定性，对10批苦地子注射液进行了分析。因此，苦碟子的质量控制 注射是一种可靠而有效的方法，可以为其他复杂中药中化学成分的定性和定量研究提供思路。