摘要
目的:建立阿胶益寿口服液中陈皮的质量控制方法。方法:采用薄层色谱法对制剂中陈皮进行薄层色谱鉴别;利用高效液相色谱法研究阿胶益寿口服液中橙皮苷的含量,用Agilent-C_(18)(250 mm×4.6 mm,5μm)色谱柱,以甲醇-0.2%磷酸(含0.1%的三乙胺)(35∶65)为流动相,流速1.0 mL/min,测量波长283 nm,进样量为10μL。结果:陈皮薄层色谱斑点清晰,分离效果好,阴性无干扰,操作简便。回归方程为y=2028574.4357x+36488.8934,r^(2)=0.9996,表明橙皮苷在0.0255~1.629μg范围内线性良好,平均加样回收率为100.25%,RSD值为0.80%。结论:本研究建立的方法简便、可靠、重现性好,可作为阿胶益寿口服液中陈皮的质量控制方法。
Objective:To establish the quality control method of Chenpi(Citri Reticulatae pericarpium)in Ejiao Yishou oral liquid.Methods:TLC was used to identify Chenpi in the preparation;HPLC was utilized to investigate the contents of hesperidin in Ejiao Yishou oral liquid,Agilent-C_(18)(250 mm×4.6 mm,5μm)chromatographic column was used,methanol-0.2%phosphoric acid(containing 0.1%triethylamine)(35:65)were chosen as mobile phase,flow rate 1.0 mL/min,detection wavelength was 283nm,and sample size was 10μL.Results:TLC of Chenpi has clear spots,good separation effects,no interference and simple operation.The regression equation is y=2028574.4357x+36488.8934,r^(2)=0.9996,which indicated that hesperidin has the good linearity between 0.0255 and 1.629μg,average recovery rate was 100.25%,RSD value was 0.80%.Conclusion:The approach established in the study,simple and convenient,reliable and reproducible,could be taken as the quality control method of Chenpi in Ejiao Yishou oral liquid.
作者
朱喜春
徐继军
朱旭江
陈乾兑
姚世霞
张明童
李成明
李子彬
ZHU Xichun;XU Jijun;ZHU Xujiang;CHEN Qiandui;YAO Shixia;ZHANG Mingtong;LI Chengming;LI Zibin(Gansu Provincial Drug Inspection Institute,Lanzhou 730070,China;State Drug Administration-Key Laboratory of Quality Control of Chinese Medicinal Materials and Decoction Pieces;Changchun University of Chinese Medicine;Gansu Provincial Hospital of Traditional Chinese Medicine)
出处
《西部中医药》
2022年第8期35-39,共5页
Western Journal of Traditional Chinese Medicine
基金
国家药典委员会2018年度国家药品标准提高工作项目(2018Z031)
兰州市中药配方颗粒研究推广实训基地项目(2019-1-127)
甘肃省药品产业技术扶持项目(2019KF004)。