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目的:探讨高良姜配方颗粒质量控制方法并为其质量控制提供参考。方法:采用薄层色谱法对不同批次高良姜配方颗粒进行定性鉴别;采用HPLC法测定其中高良姜素和山奈素的含量。phenomenex Gemini C18(4.6 mm×250 mm,5μm)色谱柱;流动相甲醇-0.4%磷酸(58∶42);检测波长360 nm;流速1.0 mL.min-1;柱温30℃。结果:薄层色谱斑点分离较好,斑点清晰;高良姜素在0.104～1.044μg呈线性关系,r=0.999 3,平均回收率98.05%,RSD 1.96%(n=6);山奈素在(2.2～21.6)ng内呈线性关系,r=0.999 2,平均回收率99.71%,RSD 1.86%(n=6)。结论:该方法简便快速,准确可靠,专属性强,可作为高良姜配方颗粒的质量控制方法。
Objective: To investigate the quality control method of Gaoliangjiang formula granules and provide reference for its quality control. METHODS: TLC was used to qualitatively identify different batches of galangal granules and the contents of galangin and kaempferol were determined by HPLC. Phenomenex Gemini C18 (4.6 mm×250 mm, 5 μm) column; mobile phase methanol-0.4% phosphoric acid (58:42); detection wavelength 360 nm; flow rate 1.0 mL.min-1; column temperature 30°C. RESULTS: Thin-layer chromatogram spots were well separated and the spots were clear; Galangin was linear in the range of 0.104-1.044 μg, r=0.999 3, the average recovery was 98.05%, RSD 1.96% (n=6); and kaempferol was (2.2). The linear relationship was between 21.6 ng, r=0.999 2, the average recovery rate was 99.71%, and the RSD was 1.86% (n=6). Conclusion: The method is simple, rapid, accurate and reliable, and it can be used as a quality control method for galangal formulation granules.