高效液相色谱法测定补骨脂配方颗粒中4种有效成分的含量  

Determination of Four Active Components in Psoraleae Fructus Formula Granules by HPLC

作　　者：张胜波 孙巧巧 李正国 顾英琳 ZHANG Shengbo;SUN Qiaoqiao;LI Zhengguo;GU Yinglin(Jining Institute of Food and Drug Inspection and Testing,Shandong Jining 272073,China;College of Pharmacy,Jining Medical University,Shandong Rizhao 276826,China)

机构地区：[1]济宁市食品药品检验检测研究院,山东济宁272073 [2]济宁医学院药学院,山东日照276826

出　　处：《中国医药导刊》2022年第11期1129-1133,共5页Chinese Journal of Medicinal Guide

基　　金：山东省中医药发展计划项目(项目编号:2019-0445,项目名称:决明子、补骨脂配方颗粒质量控制及风险评估)。

摘　　要：目的:建立同时测定补骨脂配方颗粒中补骨脂苷、异补骨脂苷、补骨脂素和异补骨脂素含量的方法。方法:使用反相高效液相色谱法进行检测。采用Hypersil GOLD TM C_(18)色谱柱(4.6 mm×250 mm,5μm),以乙腈-0.1%磷酸溶液为流动相,并采用梯度洗脱,流速为1.0 mL·min^(-1),检测波长为238 nm。结果:补骨脂苷线性范围为0.2979~1.7875μg,r=0.9995,平均回收率为99.80%,RSD为1.17%(n=6);异补骨脂苷线性范围为0.2914~1.7485μg,r=1.0000,平均回收率为98.69%,RSD为1.26%(n=6);补骨脂素线性范围为0.08558~0.5135μg,r=1.0000,平均加样回收率为98.73%,RSD为0.64%(n=6);异补骨脂素线性范围为0.05796~0.3478μg,r=1.0000,平均加样回收率为98.97%,RSD为0.95%(n=6)。结论:该方法简便、快速、准确,重现性好,可作为补骨脂配方颗粒的质量控制方法。Objective:To establish a method for simultaneous determination of psoralenoside,isopsoralenoside,psoralen,isopsoralen in psoraleae fructus formula granules.Methods:RP-HPLC method was used for detection.Hypersil GOLD TM C_(18) column(4.6 mm×250 mm,5μm)was used.The mobile phase was acetonitrile-0.1%phosphoric acid solution.Gradient elution,the flow rate was 1.0 mL·min^(-1),and the detection wavelength was 238 nm.Results:Under the above conditions,the linear range of psoralenoside was 0.2979-1.7875μg with r=0.9995,and the average recovery was 99.80%,RSD=1.17%(n=6).The linear range of isopsoralenoside was 0.2914-1.7485μg with r=1.0000,and the average recovery was 98.69%,RSD=1.26%(n=6).The linear range of psoralen was 0.08558-0.5135μg with r=1.0000.and the average recovery was 98.73%,RSD=0.64%(n=6).The linear range of isopsoralen was 0.05796-0.3478μg with r=1.0000,and the average recovery was 98.97%,RSD=0.95%(n=6).Conclusion:The method is simple,quick,accurate and reproducible,and can be used for the quality control of the psoraleae fructus formula granules.

关 键 词：HPLC法 补骨脂配方颗粒 补骨脂苷 异补骨脂苷 补骨脂素 异补骨脂素 

分 类 号：R927[医药卫生—药学]