龙胆泻肝丸的质量标准补充研究

目的: 对龙胆泻肝丸(水丸)质量标准进行补充研究. 方法: 采用薄层色谱法,对当归、泽泻、黄芩、柴胡、甘草、23-乙酰泽泻醇B、龙胆苦苷、栀子苷、甘草苷进行鉴别;采用HPLC法测定23-乙酰泽泻醇B的含量,色谱柱为Waters Symmetry C₁₈(250 mm×4.6 mm,5 μm),流动相为乙腈-0.1%磷酸水溶液(62:38),流速1.0 mL·min^-1,柱温35 ℃,检测波长208 nm. 结果: 薄层色谱斑点清晰,分离度好,专属性 强,重复性良好.23-乙酰泽泻醇B在20~2 000 ng范围内线性关系良好(r=0.999 9);平均回收率(n=6)为104.2%, RSD为0.9%. 结论: 本文建立的鉴别和含量测定方法可为龙胆泻肝丸(水丸)的质量标准完善提供参考.

Objective: To study supplements for the quality standard for Longdanxiegan pills (water pills). Methods: Angelicae Sinensis Radix, Alismatis Rhizoma, Scutellariae Radix, Bupleuri Radix, Glycyrrhizae Radix et Rhizoma, 23-acetate alisol B, gentiopicrin, gardenoside, liquiritin were identified by TLC. The content of 23-acetate alisol B was determined by HPLC. The analysis was performed on a Waters Symmetry C₁₈(250 mm×4.6 mm, 5 μm) column with the mobile phase of acetonitrile-0.1% phosphoric acid (62:38) at the flow rate of 1.0 mL·min^-1, the column temperature was 35 ℃, and the detection wavelength was 208 nm. Results: The chromatographic spots were clear with good separation, the chromatogram for identification by TLC was distinct and highly specific. The linear range of 23-acetate alisol B was 20-2 000 ng (r=0.999 9), and the average recovery was 104.2%(RSD=0.9%, n=6). Conclusion: The established identification and determination methods can provide references for improvement of quality standards for Longdanxiegan pill (water pill).

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