鹿羊乳癖康颗粒的薄层鉴别和淫羊藿苷含量测定方法研究

TLC Studies on Identification and HPLC Determination of Luyang Rupikang Granules

目的:为控制新药鹿羊乳癖康颗粒的质量,建立其有效成分淫羊藿苷、丹参酮ⅡA的鉴别定量方法。方法:鉴别用硅胶G薄层板,淫羊藿苷以醋酸乙酯-丁酮-甲酸-水(10∶1∶1∶1)为展开剂,紫外灯365nm 下检视;丹参酮ⅡA以甲苯-醋酸乙酯(19∶1)为展开剂,日光下检视。淫羊藿苷含量测定采用 HPLC 法,Intersil C_(18)(4.6mm×250mm,5μm)色谱柱,流动相乙腈-10%乙腈(23∶77),流速1.0mL·min^(-1),检测波长270nm。结果:淫羊藿苷、丹参酮ⅡA在检测条件下,分别显阳性反应。淫羊藿苷含量测定回归方程 Y=-0.2630+0.000001778X,r=0.9999。最低检测限度为0.2μg·mL^(-1),线性范围为5.625～90.000μg·mL^(-1)。精密度试验淫羊藿苷色谱峰面积的 RSD 为1.6%。结论:本文方法简便,结果稳定精确,可用于鹿羊乳癖康颗粒的质量控制方法。

Objective:To establish HPLC and TLC methods for the identification and determination of Icariin and Tanshinone ⅡA in Luyang Rupikang granules.Methods:Using G silica gel as the coating substance and ethyl ace- tate-butanone-methanoic acid-water(10:1:1:1)as the mobile phase for Icariin,and methylvenzene-ethyl acetate(19:1)for Tanshinone Ⅱ A.Examine under ultraviolet light(365 nm)and sun light.The column used was Intersil C_(18)(250 mm×4.6 mm,5μm),the mobile phase used was acetonitrile-10% acetonitrile(23:77),the de- tection wavelength was set at 270 nm,and the flow rate was 1.0 mL·min^(-1).Results:The minimum detection limit is 0.2μg·mL^(-1),the calibration curve was linear in the range of 5.625～90.000 μg·mL^(-1)(r=0.9999).Con- clusion:The method is simple and sensitive,it can be used as quality control of Luyang Rupikang granules.