目的: 提升蒙药森登四味汤散的质量标准。方法: 建立森登四味汤散中文冠木、诃子、栀子和川楝子的显微鉴别;通过薄层色谱(thin layer chro-matography, TLC)法对文冠木、栀子和诃子定性鉴别;通过高效液相色谱(high performance liquid chromatography, HPLC)法测定君药文冠木中表儿茶素的含量,色谱条件是Supersil ODS-BP色谱柱(250 mm×4.6 mm,5 μm),柱温为30 ℃,乙腈-1%甲酸溶液(10∶90)作流动相,280 nm作检测波长,流速是1.0 mL/min。结果: 文冠木、栀子、川楝子和诃子的显微特征明显;采用薄层色谱法对文冠木、栀子、川楝子和诃子进行分析,结果显示各成分斑点分离良好,且阴性对照未产生干扰。表儿茶素的定量分析表明,在0.018 7～0.138 8 mg/mL浓度范围内线性关系良好,其回归方程可表示为Y=7E+06X-11 135(相关系数R²=0.999 3)。方法学验证结果显示:加样回收试验的平均回收率达98.17%,相对标准偏差为1.73%;此外,精密度、重复性和稳定性试验的RSD分别控制在0.11%、1.75%和1.55%范围内,表明该方法可靠稳定。结论: 本研究所建方法准确可靠,灵敏度高、重复性好,可以用于蒙药森登四味汤散的质量控制。

Objective: To improve the quality standard of Mengyao Senden Siwei Soup. Methods: The microscopic identification of wenguan wood, chebula, gardenia and kawakuem seed in Senden four-flavor soup was established. Thin layer chromatography (TLC) was used to qualitatively identify wenguan wood, gardenia and chebula. The content of epicatechin in Junyao Wenguan wood was determined by high-performance liquid chromatography (HPLC) under the conditions of Supersil ODS-BP column (250 mm×4.6 mm, 5 μm), column temperature of 30 ℃, acetonitrile-1% formic acid solution (10∶90) as mobile phase, 280 nm as the detection wavelength, and the flow rate was 1.0 mL/min. Results: The microscopic characteristics of wenguan wood, gardenia, kawakuem seed and chebula were obvious. Thin-layer chromatography was used to analyze the results of wenguan wood, gardenia, kawakuem seed and chebula, and the results showed that the spots of each component were well separated and the negative control was not disturbed. The quantitative analysis of epicatein showed that the linear relationship was good in the concentration range of 0.018 7-0.138 8 mg/mL, and the regression equation could be expressed as Y=7E+06X-11 135 (correlation coefficient R²=0.999 3). The results of methodological validation showed that the average recovery rate of the sample recovery test was 98.17%, and the relative standard deviation was 1.73%. In addition, the RSDs of precision, repeatability and stability tests were controlled within the range of 0.11%, 1.75% and 1.55%, respectively, indicating that the method was reliable and stable. Conclusion: The method constructed in this study is accurate, reliable, sensitive and reproducible, and can be used for the quality control of Mongolian medicine Senden Siwei decoction.