目的: 提升蒙药制剂嘎日西丸的质量控制标准。方法: 试验采用显微鉴别法对嘎日西丸制剂中荜茇、土木香、全石榴、肉桂、大黄5味药材进行定性鉴别,选取薄层色谱法(thin layer chromatography, TLC)对嘎日西丸中荜茇、土木香、肉桂进行定性鉴别;同时测定嘎日西丸中胡椒碱含量,使用高效液相色谱法(high performance liquid chromatography, HPLC)进行含量测定。采用依利特SinoPak SP色谱柱(4.6×250 mm,5 μm),以甲醇-水为流动相进行梯度洗脱,柱温设定30 ℃,检测波长343 nm,流速控制为1.0 mL/min。结果: 显微鉴别特征明显;TCL鉴别结果显示,荜茇、土木香、肉桂斑点清晰,专属性强,分离度良好,阴性无干扰,易于鉴别;胡椒碱峰面积在0.010 5～0.089 8 mg/mL浓度范围内线性关系良好;回归方程为Y=1 110.7X+1.015 7(R2=0.999 6);平均加样回收率为105.25%,RSD=1.90%。结论: 本研究建立的蒙药制剂嘎日西丸质量标准分析方法,具有操作简便、结果准确、重复性与精密度良好、专属性强的特点,可为该制剂的质量控制提供可靠依据。
Objective: Improve the quality control standards for the Mongolian medicine preparation Garixi pill. Methods: The experiment employed microscopic identification methods to qualitatively identify the five herbal ingredients-Piper longum, Cinnamomum cassia, Punica granatum, Cinnamomum cassia, and Rheum palmatum-in the Garixi pill formulation. Thin-layer chromatography (TLC) was selected to perform qualitative identification of Piper longum, Cinnamomum cassia, Cinnamon in the Garixi pill. Simultaneously, the content of piperine in the Garixi pill was determined using high-performance liquid chromatography (HPLC). An Elit SinoPak SP column (4.6 × 250 mm, 5 μm) was used, with methanol-water as the mobile phase for gradient elution. The column temperature was set to 30 ℃, the detection wavelength was 343 nm, and the flow rate was controlled at 1.0 mL/min. Results: The microscopic identification characteristics were obvious. The results of TLC identification showed that long pepper fruit, elecampane inula root and cassia bark had clear spots, strong specificity, good separation, negative without interference and easy identification. The peak area of piperine had a good linear relationship in the concentration range of 0.010 5-0.089 8 mg/mL. The regression equation was Y=1 110.7X+1.015 7 (R2=0.999 6). The average recovery was 105.25%, RSD=1.90%. Conclusion: The quality standard analysis method of Mongolian medicine Garixi pill established in this study has the characteristics of simple operation, accurate results, good repeatability and precision, and strong specificity, which can provide a reliable basis for the quality control of the preparation.
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