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建立麻黄标准汤剂质量评价体系

[Establish quality evaluation system for standard Ephedrae Herba decoction].

作者信息

Tong Jia-Yu, Chao Jung, Dai Yun-Tao, Fan Zi-Quan, Wang Dan-Dan, Qin Xue-Mei, Chen Shi-Lin

机构信息

Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China.

Shanxi University, Modern Research Center for Traditional Chinese Medicine, Taiyuan 030006, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2017 Mar;42(5):823-829. doi: 10.19540/j.cnki.cjcmm.20170121.011.

Abstract

To establish the quality control methods for the standard decoction of Ephedrae Herba, and provide the reference for quality evaluation method of all Chinese herbal medicine decoction.Standard decoction of Ephedrae Herba was prepared, and UPLC-UV fingerprint was established to determine the total contents of ephedrine and pseudoephedrine. Then UPLC-QTOF/MS was used to confirm the major common peaks in the fingerprint to clarify the main chemical constituents in the decoction. In addition, the stability of the process was evaluated by calculating the parameters such as the extraction ratio, transfer rate of the index components and the pH values.In the decoction of Ephedrae Herba, the total average concentration of ephedrine and pseudoephedrine was (2.11±0.70) g•L⁻¹; the similarities of all the fingerprints were more than 0.85; there were 10 major common peaks in the fingerprint, including alkaloids, flavonoids and organic acids; the extraction ratio was (17±3.2)%, and the overall transfer rate of ephedrine and pseudoephedrine was (32.4±8.1)%.The method for evaluating the quality of standard decoction of Ephedrae Herba was established in this article, providing reference for the quality control of products which were stemmed from the water extract of Ephedrae Herba.

摘要

建立麻黄标准汤剂的质量控制方法,为所有中药汤剂的质量评价方法提供参考。制备麻黄标准汤剂,建立超高效液相色谱 - 紫外指纹图谱以测定麻黄碱和伪麻黄碱的总含量。然后采用超高效液相色谱 - 四极杆飞行时间质谱联用技术确认指纹图谱中的主要共有峰,以阐明汤剂中的主要化学成分。此外,通过计算提取率、指标成分转移率和pH值等参数来评估该工艺的稳定性。麻黄汤剂中麻黄碱和伪麻黄碱的总平均浓度为(2.11±0.70)g•L⁻¹;所有指纹图谱的相似度均大于0.85;指纹图谱中有10个主要共有峰,包括生物碱、黄酮类和有机酸;提取率为(17±3.2)%,麻黄碱和伪麻黄碱的总转移率为(32.4±8.1)%。本文建立了麻黄标准汤剂的质量评价方法,为以麻黄水提取物为原料的产品质量控制提供参考。

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