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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?m),以乙腈-水(32∶68)为流动相,流速1.0 m L·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 9μg(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。
Objective To establish and improve the quality standard of Xiaobai Granule. Methods The TLC was used to identify Astragalus membranaceus, Radix Rehmanniae, Radix Polygoni multiflori and Radix Psoraleae, and the content of Astragaloside Ⅳ was determined by HPLC-ELSD. Chromatographic conditions: Lichrospher-C18 column (4.6 mm × 250 mm, 5 μm) with acetonitrile-water (32:68) as the mobile phase at a flow rate of 1.0 m L · min -1 and column temperature of 25 ° C by evaporative light scattering Detector. Results Xiaobai particles Astragalus, Rehmannia, Radix, psoralen TLC spots clear, good resolution, negative non-interference. Astragaloside had a good linear relationship in the range of 0.311 5 ~ 2.803 9 μg (r = 0.999 9) with an average recovery of 99.4% (RSD = 2.67%). Conclusion The method is simple, accurate and reproducible, and can be used as the quality standard of Xiaobai granules.