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目的建立补脾强力膏的质量控制方法。方法采用TLC法鉴别方中黄芪、淫羊藿及白附片,并采用TLC法对方中的乌头碱进行了限量检查;采用HPLC测定补脾强力膏中黄芪甲苷。色谱柱为Symmetry C18(5μm,150 mm×4.6mm),乙腈-水为流动相,检测器为蒸发光散射检测器。结果薄层色谱鉴别方法专属性强,斑点清晰,且阴性无干扰;黄芪甲苷线性范围为2.04~10.2μg,r=0.999 9。结论该质量标准方法结果准确、重复性好,可有效控制该制剂的质量。
Objective To establish a quality control method for strengthening spleen and strengthening ointment. Methods TLC method was used to identify Astragalus membranaceus, epimedium and white tablets, and TLC method was used for the determination of aconitine in the other side. The column was Symmetry C18 (5 μm, 150 mm × 4.6 mm) with acetonitrile-water as the mobile phase and the detector was an evaporative light scattering detector. Results The TLC identification method was characterized by specificity, clear spots and negative without interference. The linear range of astragaloside was 2.04-10.2 μg, r = 0.999 9. Conclusion The quality standard method is accurate and reproducible, which can effectively control the quality of the preparation.