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目的:建立首乌丸质量标准。方法:采用TLC法对地黄、牛膝进行鉴别;用HPLC法测定大黄素的含量,色谱柱为Kro-masil ODS柱(150 mm×4.6 mm,5μm),流动相为甲醇-水-冰醋酸(80∶20∶1),流速1.0 mL·min-1,检测波长437 nm。结果:TLC色谱斑点清晰;大黄素在13.66～136.6μg·mL-1范围内线性关系良好(r=0.9999),平均回收率(n=6)为99.92%(RSD为0.84%)。结论:本法简便、可靠、准确,可用于该制剂的质量控制。
Objective: To establish the quality standard of Shouwu pill. Methods: TLC method was used to identify Radix Rehmanniae and Achyranthes bidentata. The content of emodin was determined by HPLC. The column was a Kro-masil ODS column (150 mm×4.6 mm, 5 μm) and the mobile phase was methanol-water-glacial acetic acid ( 80:20:1), flow rate 1.0 mL·min-1, detection wavelength 437 nm. RESULTS: TLC chromatographic spots were clear. The emodin ranged linearly from 13.66 to 136.6 μg·mL-1 (r=0.9999). The average recovery (n=6) was 99.92% (RSD was 0.84%). Conclusion: This method is simple, reliable and accurate and can be used for the quality control of the preparation.