HPLC-DAD法测定冠脉宁片中葛根素和丹酚酸B的量及其指纹图谱研究  

The HPLC-DAD determination of puerarin and salvianolic acid B in Guanmaining tablets and its fingerprint chromatogram study

作　　者：丁宁 何轶[2] 何玉梅[3] 王栋 王瑞忠[2] 鲁静[2] 戴忠[2] 马双成[2] 

机构地区：[1]内蒙古食品药品检验所中药室,呼和浩特010011 [2]中国食品药品检定研究院中药民族药检定所中成药室,北京100050 [3]武警总医院中医科,北京100039

出　　处：《首都医科大学学报》2015年第6期958-963,共6页Journal of Capital Medical University

基　　金：国家十二五"重大新药创制"专项(2014ZX09304307-002)~~

摘　　要：目的建立冠脉宁片中葛根素和丹酚酸B的量的测定方法,并对其指纹图谱进行初步研究。方法采用HPLC-DAD法分别对葛根素和丹酚酸B进行量的测定,并采用此方法对冠脉宁片的指纹图谱进行初步研究。所使用的色谱柱为Phenomenex Luna C18柱（250 mm×4.6 mm,5μm）,流动相为甲醇和0.5%甲酸溶液梯度洗脱,检测葛根素波长为250 nm,丹酚酸B为286 nm。结果葛根素和丹酚酸B分别在0.002 523~0.504 6 mg/m L和0.002 657~0.425 2mg/m L的范围内呈良好的线性关系。平均回收率分别为99.53%（n=6,RSD=1.5%）和102.2%（n=6,RSD=1.4%）。56批样品的指纹图谱相似度计算结果为0.25~0.98。结论所建立的检测方法简便、准确、快速,可用于冠脉宁片的质量控制。Objective To establish a method for the detection of pueratin and salvianolic acid B in Guanmaining Tablets,and to study the fingerprint chromatogram of the preparation. Methods HPLC-DAD was used for the quantitative determination of puerarin and salvianolic acid B,and fingerprint chromatogram study of Guanmaining Tablets. The column of Phenomenex Luna C18（ 250 mm × 4. 6mm,5 μm） was used as a stationary phase,the mixture of methanol and 0. 5% formic acid was used as a mobile phase in gradient elution mode,and the detection wavelengths were 250 nm for puerarin and 286 nm for salvianolic acid B. Results Puerarin and salvianolic acid B showed good linear relationships in the ranges of 0. 002 523 ~ 0. 504 6 mg / m L and 0. 002 657 ~ 0. 425 2 mg / m L,respectively. The average recoveries were 99. 53%（ n = 6,RSD = 1. 5%） for puerarin and 102. 2%（ n = 6,RSD = 1. 4%） for salvianolic acid B. In the fingerprint study,the similarity computation results of 56 samples ranged from 0. 25 to 0. 98. Conclusion The method is simple,accurate,and quick and can be used for the quality control in Guanmaining tablets.

关 键 词：冠脉宁片 葛根素 丹酚酸B 指纹图谱 

分 类 号：R965.2[医药卫生—药理学]