Zhang Zhongliang, Li Qiang, Li Qiufen, Du Simiao, Zhou Yongquan, Lv Chunming, Zhao Yan, Wang Yongjun, Zhang Ning
Experimental Center for Science and Technology, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.
Institute of Spine, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.
Acta Pharm Sin B. 2014 Oct;4(5):384-93. doi: 10.1016/j.apsb.2014.05.003. Epub 2014 Jul 15.
Qi She Pill (QSP) is a traditional Chinese medicine (TCM) prescription that has been used in treating cervical spondylosis radiculopathy for many years. In this study, a simple and sensitive method using ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) on a reverse-phase C18 column was developed for the simultaneous determination of the 19 major components in QSP. We found that the optimum mobile phase for gradient elution was 0.1% formic acid and methanol. The correlation coefficients of all calibration curves were greater than 0.99. Recoveries measured at three concentration levels varied from 95.43% to 102.35%. Relative standard deviations of intra- and inter-day precisions were less than 4.45%. After successfully validating our method, we then applied it to the quantification of 19 components in QSP products to show that this method provides a new standard in quality assessment of TCM prescriptions containing multiple bioactive components.
芪麝丸（QSP）是一种多年来一直用于治疗神经根型颈椎病的中药方剂。在本研究中，建立了一种在反相C18柱上使用超高效液相色谱-串联质谱（UHPLC-MS/MS）的简单灵敏方法，用于同时测定芪麝丸中的19种主要成分。我们发现梯度洗脱的最佳流动相为0.1%甲酸和甲醇。所有校准曲线的相关系数均大于0.99。在三个浓度水平下测得的回收率在95.43%至102.35%之间。日内和日间精密度的相对标准偏差均小于4.45%。在成功验证我们的方法后，我们将其应用于芪麝丸产品中19种成分的定量分析，结果表明该方法为含有多种生物活性成分的中药方剂质量评估提供了新的标准。
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