高效液相色谱法同时测定银翘解毒丸中3种成分含量

Simultaneous Determination of Three Components in Yinqiao Jiedu Pills by High Performance Liquid Chromatography

目的:建立银翘解毒丸中多成分含量测定方法,为银翘解毒丸的质量评价与质控标准提供参考依据。方法:采用高效液相色谱法(HPLC),在30℃柱温的条件下,以1 mL/min为流速,岛津C18(4. 6 mm×250 mm,5μm)为色谱柱,使用乙腈-0. 1%甲酸为流动相进行梯度洗脱,分别于327 nm、280 nm与277 nm波长下,测定样品中绿原酸、牛蒡苷与连翘苷的含量。结果:绿原酸在0. 1718~1. 9786μg具有良好的线性范围,平均回收率为99. 47%,RSD值为1. 10%;牛蒡苷在0. 1418~2. 5733μg具有良好的线性范围,平均回收率为99. 32%,RSD值为1. 15%;连翘苷在0. 1573~1. 5787μg具有良好的线性范围,平均回收率为99. 10%,RSD值为1. 32%。四个不同厂家(北京同仁堂、九芝堂、太极集团与药都制药集团有限公司)生产的银翘解毒丸中绿原酸的含量分别为1. 74 mg/g、1. 57 mg/g、1. 18 mg/g、1. 23 mg/g,牛蒡苷的含量分别为2. 48 mg/g、2. 11 mg/g、1. 66 mg/g、1. 75 mg/g,连翘苷的含量分别为0. 32 mg/g、0. 27 mg/g、0. 64 mg/g、0. 51mg/g。结论:高效液相色谱法具有快速简便、准确度高、重复性、专属性与稳定性较好等优点,是一种比较理想的测定银翘解毒丸中各组分含量的方法,可为银翘解毒丸的质量评价提供参考,同时有利于完善质量标准。

Objective:To establish a method for determination of multi-components in Yinqiao Jiedu Pills and provide the reference for the quality evaluation and quality control standards of Yinqiao Jiedu Pills.Methods:Using high performance liquid chromatography(HPLC)at a column temperature of 30℃and a flow rate of 1 mL/min.Shimadzu C18(4.6 mm×250 mm,5μm)was used as a column and using acetonitrile-0.1%formic acid was as a mobile phase for gradient elution.The contents of chlorogenic acid,arctiin and forsythin were determined at 327 nm,280 nm and 277 nm,respectively.Results:Chlorogenic acid had a good linear range of 0.1718-1.9786μg.The average recovery was 99.47%,and the RSD value was 1.10%.The burdock had a good linear range at 0.1418-2.5733μg,and the average recovery was 99.32%.RSD value was 1.15%.The forsythin had a good linear range at 0.1573-1.5787μg and the average recovery was 99.10%,and the RSD value was 1.32%.The content of chlorogenic acid in Yinqiao Jiedu Pills produced by four different manufacturers(Beijing Tongrentang,Jiuzhitang,Taiji Group and Yaodu Pharmaceutical Group Co.,Ltd.)was 1.74 mg/g,1.57 mg/g,1.18 mg/g,1.23 mg/g,respectively.The content of burdock was 2.48 mg/g,2.11 mg/g,1.66 mg/g,1.75 mg/g,and the content of forsythin was 0.32 mg/g,0.27 mg/g,0.64 mg/mg,0.51 mg/g,respectively.Conclusion:High performance liquid chromatography(HPLC)is fast,simple,accurate,reproducible,specific and stable.It is an ideal method for determining the content of each component in Yinqiao Jiedu Pills,providing a reference for the quality evaluation and at the same time help to improve the quality standards.