狗仔花饮片标准汤剂的质量标准研究

Study on quality standard of Vernonia patula standard decoction

  • 摘要: 目的: 制备狗仔花标准汤剂,建立狗仔花标准汤剂质量标准,为后续狗仔花配方颗粒及其相关制剂质量标准的制定提供参考。方法: 制备15批狗仔花标准汤剂,建立狗仔花饮片和标准汤剂特征图谱,确认共有峰,通过共有峰传递数、指标成分转移率和出膏率对标准汤剂进行量值传递规律分析。结果: 狗仔花饮片和标准汤剂特征图谱均标定出7个相同的共有峰,说明共有峰均能从饮片传递到标准汤剂中,饮片和标准汤剂特征图谱相似度均>0.9。15批标准汤剂绿原酸的含量为0.25~0.40 mg/g,均值为 0.34 mg/g,转移率为 26.19%~38.52% ;咖啡酸的含量为 0.07~0.12 mg/g,转移率为 84.37%~134.93%。15批狗仔花标准汤剂出膏率在11.53%~14.02%,浸出物在6.42%~9.16%。结论: 本研究建立的高效液相色谱(HPLC)特征图谱和含量测定方法呈现良好的精密度、重复性和稳定性,为狗仔花饮片及其制剂质量标准的制定提供参考,同时为狗仔花中药配方颗粒产品质量控制奠定基础。

     

    Abstract: Objective: To prepare the standard decoction of Vernonia patula and establish the quality standard of Vernonia patula standard decoction, so as to provide reference for formulation of the quality standard of Vernonia patula formula granules and its related preparations. Methods: Fifteen batches of Vernonia patula standard decoction were prepared. The fingerprints of decoction pieces and standard decoction were established, and the common peaks in the fingerprints were confirmed. The law of quality value transmitting of Vernonia patula standard decoction was analyzed by the transfer number of common peaks, the transfer rate and extraction ratio of the index components. Results: There were 7 common peaks in the fingerprints of Vernonia patula decoction pieces and standard decoction, indicating that the common peaks could be transferred from the decoction pieces to the standard decoction. The similarity of fingerprints of Vernonia patula and standard decoction was greater than 0.9. The content range of chlorogenic acid in 15 batches of standard decoction was 0.25-0.40 mg/g, with an average of 0.34 mg/g, and the transfer rate range was 26.19%-38.52%. The content range of caffeic acid was 0.07-0.12 mg/g and the transfer rate range was 84.37%-134.93%. The extraction rate of 15 batches of Vernonia patula standard decoction was between 11.53% and 14.02%, and the extracts ranged from 6.42% to 9.16%. Conclusion: The fingerprints and content determination method of high-performance liquid chromatography (HPLC) method demonstrate good precision, repeatability, and stability, which provides reference for the formulation of the quality standards of Vernonia patula and preparations. Additionally, it lays a foundation for the quality control of Vernonia patula traditional Chinese medicine formula granule products.

     

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