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目的:研究并完善消脂平片的质量标准。方法:采用薄层色谱法鉴别了消脂平片中的黄芪、丹参和大黄,采用高效液相色谱-蒸发光散色法对消脂平片中的黄芪甲苷进行含量测定,色谱柱为Lichrospher-C_(18)(4.6mm×250 mm,5μm);流动相为乙腈-水(32∶68),1 mL·min~(-1)等度洗脱;漂移管温度75℃;气体压力25 psi。结果:薄层色谱分离度好,斑点清晰;黄芪甲苷的进样量在0.471 336~4.242 024μg(r~2=0.999 3)范围内与峰面积呈良好的线性关系,平均加样回收率为102.44%(n=5),RSD为2.45%。结论:该方法简便、可靠,可作为该制剂的质量控制方法。
Objective: To study and improve the quality standard of Cellulite Tablets. Methods: Astragalus membranaceus, Radix Salviae Miltiorrhizae and Rhubarb were identified by TLC. The content of Astragaloside Ⅳ in Xiaoyao Tablets was determined by HPLC-Evaporative light scattering method. The chromatographic column was Lichrospher The mobile phase consisted of acetonitrile-water (32:68), isocratic elution at 1 mL · min -1, drift tube temperature at 75 ℃, gas pressure at 25 ℃ psi. Results: TLC showed good resolution and clear spots. The injection volume of Astragaloside IV showed a good linear relationship with the peak area in the range of 0.471 336 ~ 4.242 024μg (r ~ 2 = 0.999 3), and the average recovery was 102.44% (n = 5), RSD 2.45%. Conclusion: The method is simple and reliable, which can be used as quality control method of the preparation.