目的: 提升与优化蒙药制剂崩巴热-7味丸的质量标准。方法: 对蒙药崩巴热-7味丸中肉桂、山柰、木香和枸杞子四味药材进行显微鉴别;采用薄层色谱(thin layer chromatography, TLC)法对崩巴热-7味丸中枸杞子、木香及肉桂进行定性鉴别;利用高效液相色谱(high performance liquid chromatography, HPLC)法检测肉桂中桂皮醛含量,流动相为乙腈-水(34∶66),柱温:25 ℃,检测波长:290 nm,流速参数:1.0 mL/min。结果: 崩巴热-7味丸显微鉴别中肉桂、山柰、木香和枸杞子的药材粉末特征明显。TLC检测表明,供试品与对照品于同一色谱位置呈现出颜色相同的特征性斑点,且阴性对照样品未出现杂斑干扰,该方法具备良好的专属性;桂皮醛峰面积在7.38～21.95 μg/mL浓度范围内线性关系良好,回归方程为y=0.483 9x-0.454 6(R²=0.999 1);平均回收率为101.4%、100.4%、102.1%,RSD为0.84%、0.35%、0.44%。结论: 本研究构建的蒙药制剂崩巴热-7味丸显微鉴别、薄层鉴别及含量测定方法,经验证具备精准性、高灵敏度、良好重复性与精密度,且专属性优异,可有效助力该蒙药制剂质量标准的提升与优化。

Objective: To optimize and improve the quality standards of the Mongolian medicine Bengbare-7 flavor pills. Methods: Microscopic identification was carried out for four medicinal materials including Cinnamomi Cortex, Kaempferiae Rhizoma, Aucklandiae Radix and Lycii Fructus in Mongolian medicine Bengbare-7 flavor pills. Thin layer chromatography (TLC) method was used for the qualitative identification of Lycii Fructus, Aucklandiae Radix and Cinnamomi Cortex. High performance liquid chromatography (HPLC) method was adopted to determine the content of cinnamaldehyde, the main component in Cinnamomi Cortex. The mobile phase was acetonitrile-water (34∶66), the column temperature was 25 ℃, the detection wavelength was 290 nm, and the flow rate was 1.0 mL/min. Results: The powder characteristics of Cinnamomi Cortex, Kaempferiae Rhizoma, Aucklandiae Radix and Lycii Fructus had been distinct in the microscopic identification of Bengbare-7 flavor pills. TLC detection showed that the test sample and the reference substance showed characteristic spots of the same color at the same chromatographic position, and the negative control sample did not show speckle interference. with good specificity. The peak area of cinnamaldehyde had a good linear relationship in the concentration range of 7.38-21.95 μg/mL, and the regression equation was y=0.483 9x-0.454 6 ( R²=0.999 1), the average recovery was 101.4%, 100.4%, 102.1%, RSD was 0.84%, 0.35%, 0.44%. Conclusion: The microscopic identification, thin layer chromatography identification and content determination method of Mongolian medicine Bengbare-7 flavor pills constructed in this study have been verified to have accuracy, high sensitivity, good repeatability and precision, and excellent specificity, which can effectively help the improvement and optimization of the quality standard of Mongolian medicine preparation.