世界中医药

目的:建立蒙药苏木六味汤散的质量标准。方法：采用薄层色谱（TLC）定性鉴别制剂中苏木，木香，槟榔，高良姜等；以高效液相色谱法（HPLC）测定苏木中巴西苏木素和原苏木素B的含量：色谱柱Topsil-C18（4.6 mm×250 mm，5 μm)，流动相为乙腈-水（11:89），检测波长为285 nm，流速1 mL/min，柱温30 ℃,进样量为10 μL。结果：苏木，木香，槟榔，高良姜TLC图斑点清晰、专属性强；巴西苏木素与原苏木素B的进样量分别在112.875～564.375 ng、71.975～359.875 ng范围内与各自峰面积呈良好的线性关系(r分别为0.9997和0.999 9)。精密度、稳定性、重复性实验RSD%均小2.0%,加样回收率分别为99.24%、98.06%,RSD分别为0.12%、0.93%。结论：所建立的定性鉴别方法专属性强、重复性好、定量方法简便、准确、可靠，可用于传统蒙药苏木六味汤散的质量控制。

English Summary:

To establish the quality standard of traditional Mongolian Sumu Liuwei Tangsan. Methods:Lignum Sappan, Radix Aucklandiae, Semen Arecae and Rhizoma Alpiniae Officinarum were identified by TLC qualitatively. The content of brazilin and protosappanin B in Lignum Sappan was determined by HPLC. The separation was performed on Topsil C18 (4.6 mm×250 mm, 5 μm) with mobile phase consisted of acetonitrile-water (11:89) at the flow rate of 1.0 mL/min. The detection wavelength was set at 285 nm. The column temperature was 30 ℃. The sample size was 10 μL. Results:The TLC spots of Lignum Sappan, Radix Aucklandiae, Semen Arecae and Rhizoma Alpiniae Officinarum were clear and specific. The linear range was 112.875-564.375 ng for brazilin (r=0.9997) and 71.975-359.875 ng for protosappanin B (r=0.9999) respectively. The RSDs of precision, stability and repeatability tests were no more than 2%. The average recoveries were respectively 99.24 % (RSD=0.12 %, n=6) and 98.06 % (RSD=0.93 %, n=6). Conclusion:The qualitative identification is specific and reproducible, and quantitative method is simple, accurate and reliable, which can be used for the quality control of traditional medicine Sumu Liuwei Tangsan.

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