乌梅散颗粒的质量标准研究

目的建立乌梅散颗粒（乌梅、熟地、麦冬、炙甘草）的质量标准。方法采用薄层色谱法（TLC）对乌梅、熟地、麦冬、炙甘草进行鉴别;采用高效液相色谱法测定乌梅散中梓醇的含量。色谱条件为Synergi（4.6 mm×250mm,5μm）谱柱;流动相为乙腈-水（2∶98）;检测波长为206nm;流速为1.0ml/min;柱温为室温。结果建立了乌梅、熟地、麦冬、炙甘草的薄层定性鉴别的方法;建立了HPLC测定乌梅散中梓醇含量的方法,梓醇在1.0-40μg范围内线性关系良好,梓醇的平均回收率为99.48%,RSD为2.57%。结论建立的乌梅散颗粒鉴别及梓醇含量测定方法简单、易于操作、准确度高、重现性好,可用于乌梅散颗粒的质量控制。

STUDY ON QUALITY STANDARD OF PLUM POWDER GRANULE

Objective To establish the quality standard of plum powder granule（plum,Radix Rehmanniae, Radix Ophiopogonis,Glycyrrhiza uralensis Fisch.）.Methods Plum,Radix Rehmanniae,Radix Ophiopogonis,Glycyrrhiza uralensis Fisch were identified by TLC.The content of catalpol was determined by HPLC, Synergi（4.6 mm×250 mm,5μm）was used as the chromatographic column;The acetonitrile-water（2∶98） was used as mobile phase;The detection wavelength was at 206 nm;The flow rate was 1.0ml.min-1.Results The TLC method was established to identify the plum,Radix Rehmanniae,Radix Ophiopogonis,Glycyrrhiza uralensis Fisch.The HPLC method was established to determine the content of catalpol in plum powder granule.The linearity of catalpol was good in the range of 1.0-40μg.The average recovery rate of catalpol was 99.48%,RSE=2.57%.Conclusion The method which was established to indentify the plum powder granule and to determine the content of catalplo is simple,reliable,accurate and can be applied as the quantity control method of plum powder granule.