基于薄层色谱与一测多评法的沙棘颗粒质量评价方法研究

目的 优化中成药沙棘颗粒的薄层鉴别方法，建立多成分高效液相色谱一测多评方法。方法 采用薄层色谱法对槲皮素、异鼠李素和山柰素进行定性鉴别；采用高效液相色谱法，C₁₈色谱柱（250 mm×4.6 mm，5 μm），流动相为乙腈-0.1%磷酸水溶液，梯度洗脱，流速为1.0 mL·min^–1，柱温为35 ℃，检测波长为365 nm，以槲皮素为内参物计算异鼠李素和山柰素含量。结果 薄层色谱鉴别方法斑点清晰、专属性好；与外标法对比，一测多评法准确度高、耐用性好。结论 优化的薄层色谱法与建立的一测多评法可靠、准确、重复性好，可为沙棘颗粒的质量标准提升提供参考。

Quality Evaluation of Shaji Granules Based on Thin Layer Chromatography and Quantitative Analysis of Multi-components by A Single Marker

Objective To optimize the thin layer chromatography (TLC) and establish a quantitative analysis of multi-components by a single marker (QAMS) method for Shaji Granules.Methods Quercetin, isorhamnetin and kaempferol were qualitatively identified by TLC. A high-performance liquid chromatography (HPLC) was established using C₁₈ column (250 mm×4.6 mm, 5 μm) with acetonitrile-0.1% phosphoric acid solution as mobile phase in gradient elution at a flow rate of 1.0 mL·min^-1. The column temperature was 35 ℃, and the detection wavelength was 365 nm. Isorhamnetin and kaempferol were determined with quercetin as internal reference.Results TLC had good specificity and the spots were clear. Compared with the external standard method, the QAMS method was accurate and feasible.Conclusion The optimized TLC and the established QAMS method were reliable, accurate and reproducible, which could provide a comprehensive reference for improving the quality control standards of Shaji Granules.