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    益肝片的质量标准研究

    Study on the quality standard of Yigan tablet

      摘要
    • 摘要: 目的：提升益肝片的质量标准。方法：采用薄层色谱法（TLC）鉴别益肝片中的板蓝根、虎杖；采用高效液相色谱法（HPLC）对益肝片中的（R，S）-告依春和大黄素进行含量测定。结果：通过TLC鉴别板蓝根、虎杖，相应斑点清晰、分离度好，阴性无干扰。（R，S）-告依春在进样量0.03～0.15 μg范围内与峰面积线性关系良好（r=0.999 8），平均加样回收率为97.05%，大黄素在进样量0.049 5～0.297 μg范围内与峰面积线性关系良好（r=1.000 0），平均加样回收率为99.24%。结论：本质量标准能有效鉴别益肝片中的板蓝根、虎杖，也能有效测定（R，S）-告依春和大黄素的含量，且该法简便、可靠、重复性好，可用于益肝片的质量控制。

       

      Abstract: Objective: To improve the quality standard of Yigan tablet.Methods: Isatidis Radix and Polygonum cuspidatum in Yigan tablet were identified with thin layer chromatography (TLC).The content of (R, S)-Goitrin and Emodin in Yigan tablet was determined by high performance liquid chromatography (HPLC).Results: The spots of Isatidis Radix and Polygonum cuspidatum were clear, well separated and negative without interference when identified.The peak area of(R, S)-Goitrin ranged from 0.03 μg to 0.15 μg had perfect linear relationship(r=0.9998) with the injection volume, and the average recovery rate was 97.05%; the peak area of Emodin ranged from 0.0495 μg to 0.297 μg had perfect linear relationship (r=1.0000) with the injection volume, and the average recovery rate was 99.24%.Conclusion: The quality standard can not only effectively identify Isatidis Radix and Polygonum cuspidatum but also can effectively determine the content of (R, S)-Goitrin and Emodin.The method is simple, reliable and repeatable, and can be used for the quality control of Yigan tablet.

       

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