牡丹皮药材关键质量标准的优化研究
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国家重点研发计划中医药现代化研究专项(2018YFC1707004);国家中医药管理局中药标准化项目(ZYBZH-Y-AH-05)


Optimization of Key Quality Standard for the Medicinal Material Cortex Moutan Radicis
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    摘要:

    目的 优化牡丹皮药材的关键质量标准。方法 采用薄层色谱法对牡丹皮药材进行研究;采用高效液相色谱法建立牡丹皮药材的特征图谱,对芍药苷和丹皮酚含量进行测定。结果 牡丹皮药材的薄层色谱中与对照品丹皮酚及对照药材色谱相应位置上,显现相同颜色的斑点;建立了高效液相色谱法特征图谱共有模式,检出5个共有峰,生成牡丹皮药材特征图谱;18批药材中芍药苷含量为0.90%~1.70%,丹皮酚含量均符合2015版《中华人民共和国药典》的限量要求。结论 该方法对薄层色谱鉴别法进行优化,建立牡丹皮特征图谱,新增含量限量指标,专属性强,重复性好,简便高效,可更为有效地控制牡丹皮药材的质量。

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    Objective To optimize the key quality standard for the medicinal material Cortex Moutan Radicis. Methods Thin-layer chromatography (TLC) was used to analyze the medicinal material Cortex Moutan Radicis, and high-performance liquid chromatography (HPLC) was used to establish the specific chromatogram of Cortex Moutan Radicis and measure the content of paeoniflorin and paeonol. Results TLC spots with the same color were observed at the corresponding positions of the TLC chromatogram of Cortex Moutan Radicis and the chromatograms of the reference substance paeonol and the reference herb. The common model of HPLC specific chromatogram was established, 5 common peaks were detected, and the specific chromatogram of Cortex Moutan Radicis was established. Among the 18 batches of the medicinal material, the content of paeoniflorin was 0.90%-1.70%, and the content of paeonol met the requirement for limit in Pharmacopoeia of The Peoples Republic of China (2015 edition). Conclusion This method optimizes the TLC identification method, establishes the specific chromatogram of Cortex Moutan Radicis, and adds the index of content limit, with strong specificity and good repeatability. This method is simple and efficient and can effectively control the quality of Cortex Moutan Radicis.

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宋芊芊,周慧银,赵宏苏,翟宏焱,王 瑞,孙慧娟,方成武.牡丹皮药材关键质量标准的优化研究[J].安徽中医药大学学报,2020,39(5):78-82

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  • 在线发布日期: 2020-10-15