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目的提高和完善金莲清热胶囊的质量标准。方法采用薄层色谱法(TLC)对金莲清热胶囊中金莲花、大青叶、玄参和苦杏仁进行定性鉴别;采用高效液相法(HPLC),色谱柱为Phenomenex Luna C18(2)100A(250 mm×4.6 mm,5μm),以乙腈-0.4%乙酸铵溶液(15∶85)为流动相,流速1.0 m L/min,检测波长340 nm,柱温30℃,进行牡荆苷含量测定。结果金莲花、大青叶、玄参和苦杏仁的薄层色谱主斑点清晰,分离良好;牡荆苷在0.06~0.57μg(r=0.999 9)线性良好,平均加样回收率为99.7%,RSD为2.1%。结论建立的TLC和HPLC方法专属性强、准确、重复性好,可用于金莲清热胶囊的质量控制。
Objective To improve and perfect the quality standard of Jinlian heat capsule. Methods TLC (TLC) was used to qualitatively identify Trollius, Folium Isatidis, Scrophulariaceae and Bitter almonds in Jin Lian Qingre Capsules. Phenol was identified as Phenomenex Luna C18 (2) 100A (HPLC) 250 mm × 4.6 mm, 5 μm). The mobile phase was acetonitrile-0.4% ammonium acetate solution (15:85), the flow rate was 1.0 m L / min, the detection wavelength was 340 nm and the column temperature was 30 ℃. Results The main spots in TLC of Clematis, Folium Isatidis, Radix Scrophulariaceae and Bitter Almond were clear and well separated. Vitexin was linear at 0.06-0.57 μg (r = 0.999 9) with an average recovery of 99.7% RSD was 2.1%. Conclusion The established TLC and HPLC methods are specific, accurate and reproducible, and can be used for the quality control of Jinlianqinghe Capsule.