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中国医药导刊 ›› 2023, Vol. 25 ›› Issue (2): 214-218.

• 论著 • 上一篇    下一篇

牡丹皮配方颗粒生产过程中4种指标性成分含量变化研究

 王劲, 李怀伟, 付美芳   

  1. 菏泽市食品药品检验检测研究院, 山东 菏泽 274000
  • 收稿日期:2023-01-18 修回日期:2023-01-25 出版日期:2023-02-28 发布日期:2023-02-28

Determination of Content Change of Index Components in the Production of Cortex Moutan Formula Granules

  1. Heze Institute for Food and Drug Control, Shangdong Heze 274000, China
  • Received:2023-01-18 Revised:2023-01-25 Online:2023-02-28 Published:2023-02-28

摘要: 目的:测定牡丹皮配方颗粒生产过程中4种指标性成分(没食子酸、儿茶素、芍药苷、丹皮酚)含量的变化,为其生产工艺和质量控制提供实验依据。方法:采用Agilent ZORBAX SB-C18(250 mm×4.6 mm,5 μm)柱,以乙腈-0.2%磷酸溶液为流动相,梯度洗脱,流速1.0 mL·min-1,检测波长230 nm,对生产过程各阶段中4种指标成分含量进行监测。结果:没食子酸、儿茶素、芍药苷、丹皮酚的线性范围分别为1.07~107.34 μg·mL-1、1.08~108.12 μg·mL-1、1.01~101.14 μg·mL-1、1.04~104.24 μg·mL-1,相关系数r均大于0.995;不同生产工艺对儿茶素及丹皮酚的含量影响较大。结论:该方法快速、简便、准确,能快速准确测定牡丹皮配方颗粒生产过程中4种指标成分的含量,为牡丹皮配方颗粒质量控制提供依据。

关键词: font-size:medium, ">牡丹皮配方颗粒;没食子酸;儿茶素;芍药苷;丹皮酚;生产工艺

Abstract: Objective:To establish a method for simultaneous determination of four index components(gallic acid,Catechin,Paeoniflorin,Paeonol) in Cortex moutan formula granules, and analyze the influence of different production processes on the content of index components. Methods:Agilent C18 column(250 mm×4.6 mm,5 μm) was used.The mobile phase was acetonitrile-0.2% phosphoric acid solution with gradient elution at a flow rate of 1.0 mL·min-1.The detection wavelength was 230 nm.The content of the four index components in the production process was monitored. Results:Good linearity(r=0.9995-1.0000) was observed in the standard curves of gallic acid, Catechin paconiflorin and paeonol in the ranges of 1.07-107.34 μg·mL-1,1.08-108.12 μg·mL-1,1.01-101.14 μg·mL-1,1.04-104.24 μg·mL-1, respective. Different production process has significant influence on the content of catechin and paeonol. Conclusion:The method is rapid,simple and accurate and can qnickly and accurately determine the contert of four index components in the proudction process, which provides a basis for the quality control of cortex moutan formula granules.

Key words: font-size:medium, ">Cortex Moutan formula granules; Gallic acid; Catechin; Paconiflorin; Paeonol; Production process

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