蒙成药黄柏八味散质量标准研究

Quality Standards of Mongolia drug Huangbai Bawei San

目的：建立黄柏八味散中黄柏、栀子、荜茇的鉴别方法,建立红花中羟基红花黄色素A的含量测定方法.方法：采用薄层色谱法鉴别,采用高效液相色谱法测定羟基红花黄色素A的含量.色谱柱为依利特Hypersil ODS2（5μm,250mm ×4.6mm）;流动相为甲醇-0.5％乙酸溶液（20：80）;检测波长：403mm;流速：1.0mL·min-1;柱温：25℃;进样量：20μL.结果：所建立的薄层色谱图斑点清晰,分离效果好,羟基红花黄色素A在1μ·mL-1～40μg·mL-1范围内与峰面积呈良好的线性关系,回归方程为y=23290x-9400.2,r =0.9997.平均加样回收率为101.0％,RSD为0.8％.结论：所建立的薄层鉴别方法和含量测定方法简便,准确,重复性好,可作为黄柏八味散中的质量控制方法.

Objective： To establish the identification method of Cortex Phellodebdri, Fructus Gardeniae, Fructus Piperis Longi and establish the content determination of hydroxysaffor yellow A in Huangbai Bawei San. Methods：The identification was carried out by TLC. The content of hydroxysaffor yellow A was determined by HPLC. Results ：The TLC spots were clear with high resolution, while the negative sample showed no interference . A good linearity of hydroxysaffor yellow A was in the range of 1 μgomL - 1 - 40μgomL - 1 （ r = 0. 9997 ）. The average recovery was101.0% and RSD was0.8%. Conclusion： The established TLC and HPLC method is simple, accurate and with good reproducibility and can be used for the quality control standard of Huangbai Bawei San.