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UHPLC coupled with mass spectrometry and chemometric analysis of Kang-Ai injection based on the chemical characterization, simultaneous quantification, and relative quantification of 47 herbal alkaloids and saponins.

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机构： [1]Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, P. R. China. [2]Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou University, Zhengzhou, P. R. China. [3]Guangdong Province Key Laboratory of Pharmacodynamic Constituents of TCM and New Drugs Research, Jinan University, Guangzhou, P. R. China. [4]College of Pharmacy, Jinan University, Guangzhou, P. R. China.

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关键词： Kang-Ai injection chemical profile quantification chemometric analysis quality evaluation

摘要：

Kang-Ai injection, which is composed of Astragali Radix, Ginseng Radix et Rhizoma, and kushenin, is extensively used in China as an adjuvant therapy for many types of cancer and chronic hepatitis B. In the present study, 47 herbal compounds (11 alkaloids, 8 astragalosides, and 28 ginsenosides), were detected in Kang-Ai injection by ultra-high-performance liquid chromatography coupled to quadrupole time-of-flight tandem mass spectrometry, of which 31 were identified using authentic standards. Additionally, a practical ultra-high-performance liquid chromatography coupled with triple quadrupole tandem mass spectrometry method was employed for simultaneous quantitative detection (31 available compounds), and relative quantitative detection (16 unavailable compounds) within 10 min. The limit of detection and limit of quantification was 0.11-2.22 and 0.53-11.08 ng/mL, respectively. Altogether, content levels of each compound ranged from 0.03 to 9835.57 μg/mL. Furthermore, chemometric analysis indicated oxymatrine, astragaloside IV, ginsenosides Rg1 and Re, and matrine had the greatest effect on concentration fluctuation. Therefore, we suggested these five compounds should be monitored during the manufacturing process. This method can be applied to provide crucial chemical profiles and quality assessments for Kang-Ai injection, guaranteeing the safety, effectiveness, and controllability of the drug in clinics. © 2020 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

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出版当年[2019]版：

大类 | 3 区化学

小类 | 3 区分析化学

最新[2025]版：

大类 | 3 区工程技术

小类 | 3 区分析化学

第一作者：

第一作者机构： [1]Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, P. R. China. [2]Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou University, Zhengzhou, P. R. China.

通讯作者：

通讯机构： [1]Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, P. R. China. [2]Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou University, Zhengzhou, P. R. China. [3]Guangdong Province Key Laboratory of Pharmacodynamic Constituents of TCM and New Drugs Research, Jinan University, Guangzhou, P. R. China.

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