复方土茯苓颗粒定性定量方法研究

目的: 建立复方土茯苓颗粒的定性定量方法。 方法: 采用TLC法对方中君药土茯苓、臣药牛膝进行定性鉴别;采用HPLC法测定方中牛膝的蜕皮甾酮,色谱柱为Agilent TC-18(250 mm×4.6 mm,5 μm)柱,以水(A)-乙腈(B)为流动相梯度洗脱,流速1.0 mL·min^-1,检测波长243 nm。 结果: 在TLC色谱中可检出土茯苓、牛膝;在HPLC色谱中,蜕皮甾酮可与其他成分分离,且在0.176~1.232 μg范围内其峰面积与进样量呈良好的线性关系(r=0.9999,n=7),平均回收率为93.94%(RSD=1.1%,n=6)。 结论: 所建立的方法对方中的药材可准确、快速地进行定性、定量检测,可用于复方土茯苓颗粒的质量控制。

Objective: To establish the quality and quantity analysis methods of compound Tufuling granules. Methods: Rhizoma Smilacis Glabrae and Radix Achyranthis Bidentatae in compound Tufuling granules were identified by TLC;Ecdysterone in Radix Achyranthis Bidentatae of compound Tufuling granules was determined by HPLC,the determination was performed on an Agilent TC-18(250 mm×4.6 mm,5 μm)column,with a gradient elution using water(A)-acetonitrile(B)as the mobile phase at a flow rate of 1.0 mL·min^-1,and detection wavelength was 243 nm. Results: The TLC spots were fairly clear in the developed system,and the blank test showed that other medicines has not interfere with the main one;Ecdysterone showed a good linear relationship in the range of 0.176-1.232 μg(r=0.9999,n=7);The average recovery of ecdysterone was 93.94%(RSD=1.1%,n=6). Conclusion: The quality and quantity analysis methods are suitable for quality control of compound Tufuling granules,which can be used exactly and fleetly to identify and determine related medical material.