摘要
目的建立高效液相色谱法(HPLC)同时测定铁皮枫斗颗粒中人参皂苷Rg_(1)、Re、Rb_(1)含量的方法,完善铁皮枫斗颗粒质量标准,有效控制产品质量。方法采用HPLC法,流动相为乙腈-0.1%磷酸水溶液,色谱柱为Waters XSelect HSS T35μm,流速为1.0 mL/min,柱温为40℃,检测波长为203 nm,进行梯度洗脱,并对其进行方法学考察。结果研究建立了铁皮枫斗颗粒中人参皂苷Rg_(1)、Re、Rb_(1)的液相色谱条件,3批样品人参皂苷Rg_(1)、Re、Rb_(1)的总含量分别为17.85 mg/g、17.36 mg/g、17.63 mg/g;该方法重复性、稳定性、线性、精密度的相对标准偏差(RSD)值均小于2%,平均加样回收率分别为100.35%、99.59%、101.17%。结论本研究在《中华人民共和国药典》2020年版一部“西洋参”项下的基础上,结合铁皮枫斗颗粒的配方特点,通过色谱柱的筛选,改变流动相洗脱方法,解决了复方产品中色谱峰干扰的问题,建立了铁皮枫斗颗粒中人参皂苷Rg_(1)、Re、Rb_(1)含量测定方法,并对其方法进行验证,方法准确可靠,可为完善和提高铁皮枫斗颗粒的质量标准、探讨功效物质基础提供科学依据。
Objective To establish a high performance liquid chromatography(HPLC)method for the simultaneous content determination of ginsenosides Rg_(1),Re and Rb_(1)in Tiepi Fengdou Granules,to improve its quality standard,and to control the product quality effectively.Methods HPLC was applied in the study,with the mobile phase of acetonitrile-0.1%aqueous phosphoric acid,the chromatographic column of Waters XSelect HSS T35μm,the flow rate of 1.0 mL/min,the column temperature of 40℃,and the detection wavelength of 203 nm for gradient elution.Besides,the methodology was investigated.Results The liquid chromatographic conditions of ginsenosides Rg_(1),Re,and Rb_(1)in Tiepi Fengdou Granules were established,and their total contents in three batches of marketed samples were 17.85 mg/g,17.36 mg/g,and 17.63 mg/g,respectively,in which the relative standard deviations(RSD)of the method's reproducibility,stability,linearity,and precision were all less than 2%,and their average recovery rates were 100.35%,99.59%and 101.17%,respectively.Conclusion In this research,based on the 2020 edition of the Pharmacopoeia of the People's Republic of China under the item of"American ginseng",combining with the formula characteristics of Tiepi Fengdou Granules,a method for determining the content of its ginsenosides Rg_(1),Re,and Rb_(1)is established through the screening of chromatographic columns and the change in the mobile phase elution method,which solves the problem of the peaks interfering with the compound products.In addition,the method is verified to be accurate and reliable.The study is expected to provide a scientific basis for improving the quality standard of Tiepi Fengdou Granules and exploring the material basis of its effect.
作者
陈亚文
张建军
伍小芳
赵星宇
王聪慧
乔灏祎
谷洪顺
王卫茜
费文婷
李振皓
王林元
CHEN Yawen;ZHANG Jianjun;WU Xiaofang;ZHAO Xingyu;WANG Conghui;QIAO Haoyi;GU Hongshun;WANG Weiqian;FEI Wenting;LI Zhenhao;WANG Linyuan(Beijing University of Chinese Medicine,Beijing 102401,China;Beijing Cairui Institute of Pharmaceutical Science and Technology,Beijing 100094,China;Jinhua ShouXianGu Pharmaceutical Co.,Ltd.,Jinhua 321299,China)
出处
《吉林中医药》
2023年第12期1365-1370,共6页
Jilin Journal of Chinese Medicine
基金
国家重点研发计划项目(2018YFC1706800)。
关键词
铁皮枫斗颗粒
人参皂苷
含量测定
高效液相色谱法
质量标准
Tiepi Fengdou Granules
ginsenoside
content determination
high performance liquid chromatography(HPLC)
quality standard
