高效液相色谱法测定复方南板蓝根片中秦皮乙素的溶出度  

Determination of dissolution of aesculetin in compound isatis root tablets by high-performance liquid chromatography

作　　者：李兵兰 王娟 施力郜 何奕熹 LI Binglan;WANG Juan;SHI Ligao;HE Yixi(Honghe Hani and Yi Autonomous Prefecture Research Institute of Inspection and Testing,Yunnan,Mengzi 661199,China)

机构地区：[1]红河哈尼族彝族自治州检验检测院,云南蒙自661199

出　　处：《中国医药科学》2025年第5期45-48,共4页China Medicine And Pharmacy

基　　金：红河州科学技术局项目。

摘　　要：目的建立复方南板蓝根片中秦皮乙素溶出度的测定方法。方法色谱柱为Agilent 5 TC-C_(18)(2(250 mm×4.6 mm,5μm);流动相为乙腈-0.1%磷酸溶液(14∶86),流速为1 ml/min,检测波长为344 nm;柱温为35℃,进样量为20μl。溶出条件采用小杯法,以0.1 mol/L盐酸溶液为溶出介质,体积为150 ml,转速为150 r/min,100 min取样,高效液相色谱法测定,绘制溶出度曲线。结果秦皮乙素在0.2788~39.032μg/ml范围内与其峰面积的线性关系良好,回归方程y=1.1909x+1.1909(r>0.999);平均回收率为99%(RSD=1.81%,n=9);秦皮乙素精密度试验的RSD为0.29%。不同厂家复方南板蓝根片秦皮乙素的溶出度曲线不相似。结论本实验采用HPLC法测定复方南板蓝根片中秦皮乙素的溶出度,方法简便、具有复现性,可用于复方南板蓝根片秦皮乙素的溶出度测定。Objective To establish a method for determining the dissolution of aesculetin in compound isatis root tablets.Methods The chromatographic column was Agilent 5 TC-C18(2)(250 mm×4.6 mm,5μm).The mobile phase was acetonitrile-0.1%phosphoric acid solution(14∶86),the flow rate was 1ml/min and the detection wavelength was 344 nm.The column temperature was 35℃,and the sample volume was 20μl.The dissolution conditions were determined by small cup method,with 0.1 mol/L hydrochloric acid solution as dissolution medium,volume of 150 ml,rotation speed of 150 r/min,sampling for 100 min,and high-performance liquid chromatography,and the dissolution curve was drawn.Results Aesculetin had a good linear relationship with its peak area in the range of 0.2788-39.032μg/ml,and the regression equation was y=1.1909x+1.1909(r>0.999).The average recovery rate was 99%(RSD=1.81%,n=9).The RSD of aesculetin precision test was 0.29%.The dissolution curves of aesculetin in compound isatis root tablets from different manufacturers were not similar.Conclusion In this experiment,the dissolution of aesculetin in compound isatis root tablets was determined by HPLC method.The method is simple and reproducible,and can be used for the dissolution determination of aesculetin in compound isatis root tablets.

关 键 词：复方南板蓝根片 秦皮乙素 高效液相色谱法 溶出度 

分 类 号：R914[医药卫生—药物化学]