Qi‐Wei‐Tong‐Bi oral liquid (QWTB), a famous Chinese medicine preparation composed of seven crude drugs has a good therapeutic effect on rheumatoid arthritis and is widely used in China. However, its chemical composition and quality control have not been comprehensively and systematically investigated. In this study, high‐performance liquid chromatography coupled with quadrupole time‐of‐flight mass spectrometry was employed for its chemical profiling. As a result, 100 components were chemically characterized. Additionally, high‐performance liquid chromatography coupled with a quadrupole linear ion trap mass spectrometry method was developed to simultaneously quantify nine bioactive components (hyperoside, ononin, quercetin, sinomenine, magnoflorine, gallic acid, protocatechuic acid, monotropein, and cyclo‐(Pro‐Tyr)) in multiple‐reaction monitoring mode. After successful validation in terms of linearity, precision, repeatability, and recovery, the assay method was applied for the determination of 10 batches of QWTB. The results showed that QWTB was enriched in sinomenine and magnoflorine with the highest amount up to hundreds or even thousands of µg/mL, while quercetin, ononin, cyclo‐(Pro‐Tyr), and hyperoside were much lower with the lowest content below 10 µg/mL. This study work would help to reveal the chemical profiling and provide a valuable and reliable approach for quality evaluation and even pharmacodynamic material basis studies of QWTB.

中文翻译：

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基于液相色谱-质谱法的芪味通痹口服液化学成分系统分析及质量标志物相关定量分析策略

芪胃痛痹口服液（QWTB）是由七味药材组成的著名中药制剂，对类风湿性关节炎有良好的治疗作用，在我国广泛使用。但其化学成分和质量控制尚未得到全面、系统的研究。在本研究中，采用高效液相色谱与四极杆飞行时间质谱联用对其进行化学分析。结果，对 100 种成分进行了化学表征。此外，还开发了高效液相色谱结合四极杆线性离子阱质谱方法，可同时定量九种生物活性成分（金丝桃苷、洋葱素、槲皮素、青藤碱、木兰花碱、没食子酸、原儿茶酸、单托品和环-（Pro- Tyr)) 处于多反应监测模式。经过线性、精密度、重复性和回收率等方面的成功验证后，该测定方法用于10批QWTB的测定。结果表明，QWTB中富含青藤碱和木兰花碱，最高含量可达数百甚至数千μg/mL，而槲皮素、洋葱素、环酪氨酸和金丝桃苷含量较低，最低含量低于10微克/毫升。这项研究工作将有助于揭示QWTB的化学特征，并为QWTB的质量评价甚至药效物质基础研究提供有价值和可靠的方法。