消白颗粒的质量标准提升研究

    Study on Improved Quality Standard for Xiaobai Granules

    • 摘要: 目的 建立并提升消白颗粒制剂的质量标准。方法 采用TLC对消白颗粒中的黄芪、地黄、首乌、补骨脂进行定性鉴别;采用HPLC-ELSD测定制剂中黄芪甲苷的含量。色谱条件:Lichrospher-C18柱(4.6 mm×250 mm,5 mm),以乙腈-水(32∶68)为流动相,流速 1.0 mL·min-1,柱温 25 ℃,蒸发光散射检测器检测。结果 消白颗粒中黄芪、地黄、首乌、补骨脂的TLC斑点清晰,分离度良好,阴性无干扰。黄芪甲苷在0.311 5~2.803 9 μg(r=0.999 9)内呈良好的线性关系,平均回收率为99.4%(RSD=2.67%)。结论 该方法简便、准确、重复性好,可作为消白颗粒的质量标准。

       

      Abstract: OBJECTIVE To establish and improve the quality standard of Xiaobai granules. Methods TLC was used to identify Astragali Radix, Rehmanniae Radix, Polygoni Multiflori Radix, and Psoralen in Xiaobai granules. Astragloside Ⅳ in preparation was determination by HPLC-ELSD on Lichrospher-C18(4.6 mm×250 mm, 5 μm) chromatographic column, the mobile phase was acetonitrile-water(32∶68) at a flow rate of 1.0 mL·min-1, and column temperature was 25 ℃. RESULTS TLC spots were clear and well-separated without negative interference. The calibration curves of astragaloside Ⅳ demonstrated linear relationship in the range of 0.311 5-2.803 9 μg(r=0.999 9), average recovery rate was 99.4%(RSD=2.67%). CONCLUSION the method established is simple, accurate and reproducible, which can be used for the quality control of Xiaobai granules.

       

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