淫桂通便颗粒的质量标准研究

Study on Quality Standard of Yingui Tongbian Granules

目的:建立淫桂通便颗粒的质量标准。方法:采用薄层色谱法对方中淫羊藿、肉桂、葛根和厚朴进行定性鉴别,用高效液相色谱法对淫羊藿苷进行含量测定:色谱柱为Kromasil C18(250mm×4.6mm,5μm),流动相为乙腈-水(26∶74,V/V),流速为1.0ml/min,检测波长为270nm,柱温为30℃。结果:薄层鉴别斑点清晰、分离较好,阴性对照无干扰;淫羊藿苷的质量浓度在4.072～81.440μg/ml范围内与峰面积积分值呈良好的线性关系(r=0.9999),平均加样回收率为94.97%,RSD=1.21%(n=9)。结论:所用定性与定量方法简便、专属性强,结果准确、可靠;所建标准可用于淫桂通便颗粒的质量控制。

OBJECTIVE： To establish the quality standard of Yingui tongbian granules. METHODS： TLC was used for the qualitative identification of Epimedii Folium, Cinnamomum cassia, Pueraria lobata and Magnoliae Officinalis Cortex. HPLC was used to determine the content of icraiin. The determination was performed on Kromasil C18（250mm×4.6mm,5μm） column with mobile phase consisted of acetonitrile-water （26 ： 74, V/V） at the flow rate of 1.0 ml/min. The detection wavelength was set at 270 nm, and the column temperature was 30 ℃. RESULTS： TLC spots were clear and well-separated without negative interference. The linear range of icraiin was 4.072～81.440μg/ml （r=0.999 9） with an average recovery of 94.97%,RSD=1.21%（n=9. CON- CLUSION ： The method is simple, specific, accurate and reliable. It can be used for the quality control of Yingui tongbian granules.