目的:优化蒙药色木吉-德吉德丸的质量控制方法,提升其质量标准。方法:建立蒙药色木吉-德吉德丸中广枣、沉香、山柰、肉豆蔻、红花和丹参六味药材的显微鉴别方法;采用薄层色谱(thin-layer chromatography, TLC)法对沉香、肉豆蔻进行定性鉴别;利用高效液相色谱(high-performance liquid chromatography, HPLC)法测定君药沉香中沉香四醇的含量。色谱条件:流动相:乙腈-0.1%甲酸,进行梯度洗脱;柱温:30 ℃;流速:1.0 mL/min;检测波长:252 nm。结果:色木吉-德吉德丸显微鉴别中广枣、沉香、山柰、肉豆蔻、丹参和红花的药材粉末特征明显。在TLC图谱上,待测组分显示清晰的斑点,分离度良好且阴性样品无干扰。沉香四醇在59.77～179.87 μg/mL范围内线性关系良好(y=0.482 3x-4.112 8,R²=0.999 5);平均加样回收率为99.70%,RSD为1.94%,精密度、稳定性和重复性试验的RSD分别为0.73%、1.42%和2.35%。结论:优化后的质量控制方法准确易行,专属性强,具有较好重复性,可以全面提高蒙药色木吉-德吉德丸质量控制水平。

Objective: To optimize the quality control method for the Mongolian medicine Semuji-Dejide Pill and improve its quality standard. Methods: Microscopic identification methods were established for six medicinal materials in Semuji-Dejide Pill, including Choerospondias axillaris (Roxb.) B.L.Burtt & A.W.Hill, Aquilaria sinensis (Lour.) Spreng., Kaempferia galanga L., Myristica fragrans Houtt., Carthamus tinctoriusL, and Salvia miltiorrhiza Bunge. Thin-layer chromatography (TLC) was employed for the qualitative identification of Aquilaria sinensis (Lour.) Spreng. and Myristica fragrans Houtt. The content of agarotetrol in Aquilaria sinensis(Lour.) Spreng. was quantified using high-performance liquid chromatography (HPLC). The chromatographic conditions were as follows: mobile phase: acetonitrile-0.1% formic acid (gradient elution); column temperature: 30 ℃; flow rate: 1.0 mL/min; detection wavelength: 252 nm. Results: The powder characteristics of Choerospondias axillaris (Roxb.) B. L. Burtt & A. W. Hill, Aquilaria sinensis (Lour.) Spreng., Kaempferia galanga L., Myristica fragrans Houtt.,Salvia miltiorrhiza Bunge, and Carthamus tinctorius L in Semuji-Dejide Pill were clearly observed under microscopic examination. In the TLC chromatograms, the target components showed distinct spots with good resolution and no interference from negative samples. Agarotetrol exhibited a good linear relationship in the range of 59.77-179.87 μg/mL (y=0.482 3x-4.112 8, R²=0.999 5), the average recovery rate was 99.70% with an RSD of 1.94%, the RSD values for precision, stability, and repeatability tests were 0.73%, 1.42%, and 2.35%, respectively. Conclusion: This optimized quality control method is accurate, practical, highly specific, and reproducible, significantly improving the quality control of Semuji-Dejide Pill.