龙胆泻肝丸的质量标准补充研究

Supplementary study on quality standard for Longdanxiegan pills

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,5μm）,流动相为乙腈-0.1%磷酸水溶液（62∶38）,流速1.0 m L·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 of1. 0 m L·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）.