中药材蛇莓标准关键控制指标研究

Study on the key control index of Duchesneae Indicae Herba standard

目的建立中药材蛇莓的薄层色谱鉴定与含量测定方法,对其质量控制的关键性指标进行定性定量研究。方法该研究于2020年11月至2021年8月,采用薄层色谱法定性鉴别蛇莓中的熊果酸;用高效液相色谱法(HPLC)对蛇莓中的鞣花酸含量进行测定。结果不同产地批次蛇莓药材的薄层色谱斑点清晰,且供试品色谱中,在与对照品色谱相应的位置上,显示相同颜色斑点;鞣花酸在进样量2.0~20.0µg范围内有良好的线性关系(r=1.0),平均加样回收率为99.21%,相对标准差(RSD)=1.8%(n=10)。结论该定性定量方法简单、可行,重复性好、专属性强,可用于中药材蛇莓的质量控制。

Objective To establish a thin-layer chromatographic(TLC)method for the identification and content determination of the Chinese herbal medicine Duchesneae Indicae Herba,and to study its key quality control indexes qualitatively and quantitatively.Methods The study was conducted from November 2020 to August 2021,the qualitative identification of ursolic acid in Duchesneae Indicae Herba by TLC and the determination of ellagic acid in Duchesneae Indicae Herba by HPLC method were applied.Results The TLC of different origins of Duchesneae Indicae Herba showed clear spots,and the same color spots were shown on the corresponding positions of the chromatograms of the test article and the control article;ellagic acid showed good linearity in the range of 2.0-20.0µg of the injection volume(r=1.0),and the average spiked recovery was 99.21%with RSD=1.8%(n=10).Conclusion The qualitative and quantitative methods were simple,feasible,specific and reproducible,which could be used for the quality control of Duchesneae In⁃dicae Herba.