HPLC同时测定通便凝胶贴剂中白术内酯Ⅰ、藁本内酯含量  

Simultaneous Determination of the Content of Atractylenolide I and Ligustilide in Defecation Gel Patch by HPLC

作　　者：陈程[1] 李伟泽[1,2] 赵宁 杨洁[1] 龚立文 CHEN Cheng;LI Weize;ZHAO Ning;YANG Jie;GONG Liwen(Pharmaceutical Institute,Xi’an Medical University,Xi’an 710021,China;Jiangsu Weina Pharmaceutical Technology Co.,Ltd.,Yangzhong 212218,China)

机构地区：[1]西安医学院药学院,陕西西安710021 [2]江苏微纳医药科技有限公司,江苏扬中212218

出　　处：《化学与粘合》2024年第3期297-301,共5页Chemistry and Adhesion

基　　金：2022年度陕西高校青年创新团队科研计划项目(编号:22JP075);陕西省科技厅科技计划项目青年项目(编号:2023-JC-QN-0822);陕西高校青年创新团队建设项目(编号:陕教[2019]90号);西安医学院科技创新团队配套(编号:2021TDPT04)。

摘　　要：建立HPLC方法同时测定通便凝胶贴剂中白术内酯Ⅰ、藁本内酯含量。采用C_(18)色谱柱(250 mm×4.6 mm,5μm),流动相:乙腈∶水(78∶22),流速1.0 m L/min,柱温为30℃,检测波长275 nm,进样体积20μL。白术内酯Ⅰ、藁本内酯在相应的范围内与峰面积呈良好线性关系(r>0.9995);低、中、高3浓度水平9份样品的平均加样回收率分别为95.29%(RSD=2.88%)、99.19%(RSD=3.73%);仪器精密度良好,RSD依次为1.74%、1.77%;重复性好,RSD依次为1.81%、1.30%;稳定性试验符合要求,RSD依次为2.88%、2.87%;经测定,通便凝胶贴剂中白术内酯Ⅰ、藁本内酯含量为(47.07±0.61)、(988.14±6.17)μg/g。该方法简便可行准确,专属性和线性关系好,可用于通便凝胶贴剂的质量控制,并为其质量标准建立提供参考。To establish a HPLC method for simultaneous determination of atractylenolide I and ligustilide in defecation gel patches,the C_(18) column(250 mm×4.6 mm,5μm)is used with a mobile phase of acetonitrile:water(78:22)at a flow rate of 1.0 mL/min,the column temperature is 30℃,the detection wavelength is 275 nm,and the injection volume is 20μL.The atractylenolide I and ligustilide shows a good linear relationship with the peak area in the corresponding range(r>0.9995).The average recoveries of 9 samples at low,medium and high concentration levels are 95.29%(RSD=2.88%)and 99.19%(RSD=3.73%),respectively.The precision is good,the RSD is 1.74%,1.77%successively.The repeatability is good,the RSD is 1.81%and 1.30%successively.The stability test meets the requirements,the RSD is 2.88%,2.87%,respectively.The contents of atractylenolide I and ligustilide in the defecation gel patches are(47.07±0.61)and(988.14±6.17)μg/g.The method is simple,feasible,accurate,specific and linear,which can be used for the quality control of defecation gel patches and provide reference for the establishment of quality standards.

关 键 词：通便凝胶贴剂 白术内酯Ⅰ 藁本内酯 薄层鉴别 高效液相色谱法 质量控制 

分 类 号：TQ460.72[医药卫生—药物分析学]