Qualitative and quantitative analysis of multiple components for quality control of Deng-Zhan-Sheng-Mai capsules by ultra high performance liquid chromatography tandem mass spectrometry method coupled with chemometrics.

Qualitative and quantitative analysis of multiple components for quality control of Deng-Zhan-Sheng-Mai capsules by ultra high performance liquid chromatography tandem mass spectrometry method coupled with chemometrics.
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DOI:
10.1002/jssc.201600744
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发表时间:
2017-02
影响因子:
3.1
通讯作者:
Pin Jiang;Yan Lu;Dao-feng Chen
Pin Jiang;Yan Lu;Dao-feng Chen
中科院分区:
工程技术3区
文献类型:
--
作者:
Pin Jiang;Yan Lu;Dao-feng Chen

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灯盏生脉胶囊是我国研制的治疗缺血性中风的著名中成药。其质量控制主要集中于灯盏细辛,而忽略了人参、五味子、麦冬的贡献。为了提高该药物的质量标准,本工作报告了系统超高效液相色谱串联质谱方法与化学计量学的应用。建立了三个定性和定量参数用于质量评价:化学分析、18种化合物的含量与抗氧化活性之间的关系以及化学计量分析。共鉴定出55种化合物,包括20种酚酸、10种黄酮类、15种皂苷和10种木脂素。对上述18种化合物的定量测定方法进行了验证。定量限范围为 0.13 至 9.60 ng/mL。总体回收率为 95.31% 至 103.54%。对10批次样品18个成分的数据进行层次聚类分析和主成分分析。建议将灯盏花乙素、3,5-O-二咖啡酰奎尼酸、4,5-O-二咖啡酰奎尼酸、人参皂苷Rb1、人参皂苷Re、人参皂苷Rg1、麦冬皂苷D、五味子素、五味子醇B等9种化合物作为质量评价的化学标志物。
Deng-Zhan-Sheng-Mai capsules are a well-known traditional Chinese patent medicine that was developed in China for the treatment of ischemic stroke. Its quality control focuses on Erigerontis Herba but ignores the contributions of Ginseng Radix et Rhizoma, Schisandrae Chinensis Fructus, and Ophiopogonis Radix. To improve the quality standards for this medicine, this work reports the application of a systematic ultra high performance liquid chromatography tandem mass spectrometric method coupled with chemometrics. Three qualitative and quantitative parameters are established for the evaluation of quality: chemical profiling, the relationship between the contents of 18 compounds and the antioxidant activity, and chemometric analysis. A total of 55 compounds, including 20 phenolic acids, 10 flavonoids, 15 saponins, and 10 lignans, were identified. The method for the quantitative determination of the aforementioned 18 compounds was validated. The limit of quantification ranged from 0.13 to 9.60 ng/mL. The overall recoveries ranged from 95.31 to 103.54%. Hierarchical cluster analysis and principal component analysis were applied to the data of 18 components in ten batches of samples. Nine compounds, including scutellarin, 3,5-O-dicaffeoylquinic acid, 4,5-O-dicaffeoylquinic acid, ginsenoside Rb1, ginsenoside Re, ginsenoside Rg1, ophiopogonin D, schisandrin, and schisandrol B, are suggested as chemical markers for evaluating the quality.