高效液相色谱法测定中药制剂葛根汤颗粒中葛根素含量的研究  

Research on the content determination of puerarin in Chinese materia medica preparation named pueraria decoction granules by HPLC method

作　　者：游贵君 姜建伟 陈碧 YOU Guijun;JIANG Jianwei;CHEN Bi(Inspection Center of Food and Medicine Review and Adverse Reactions of Sanming City,Fujian,Sanming 365000,China;Inspection and Test Center of Sanming City,Fujian,Sanming 365000,China)

机构地区：[1]福建省三明市食品药品审评与不良反应监测中心,福建三明365000 [2]福建省三明市检验检测中心,福建三明365000

出　　处：《中国医药科学》2021年第17期80-83,共4页China Medicine And Pharmacy

摘　　要：目的采用高效液相色谱(HPLC)法测定中药制剂葛根汤颗粒中葛根素的含量。方法实验材料为葛根汤颗粒(瑞阳制药有限公司),采用HPLC法,色谱条件如下:色谱柱为Agilent ZORBAX SB-Aq C_(18)(4.6 mm×250 mm,5μm);流动相为甲醇-36%乙酸-水(25∶3∶72);柱温设定30℃;波长采用247 nm;流速为0.6 ml/min;进样量:10μl,进行线性、重复性、耐用性、稳定性、回收率等方法学考察。结果葛根素在5.31~50.59μg/ml浓度范围内与峰面积呈良好的线性关系,回归方程为y=0.4019x+0.3518,R^(2)=0.9997;重复性实验考察6个平行样品,平均值为6.92 mg/g,RSD为0.97%,表明重复性良好;稳定性实验考察24 h样品含量变化,RSD为0.68%,表明稳定性良好;耐用性实验分别进行不同流速、不同柱温、不同色谱柱条件下葛根素含量的考察,RSD分别为0.95%、0.63%、1.21%,耐用性良好。回收率实验分别考察低、中、高三组不同对照品加入量,回收率的平均值为97.16%,RSD为0.90%,表明回收率良好。考察三批样品,每批5个平行试样,结果表明三批样品含量测定平均值是(6.90±0.01)mg/g,批内与批间差异均不大。结论本研究方法准确性高、可靠性强、重复性与灵敏度高,可用作质量标准的建立。Objective To determine the content of puerarin in Chinese materia medica preparation named pueraria decoction granules by high-performance liquid chromatography(HPLC)method.Methods The experimental materials were pueraria decoction granules(Reyoung Pharmaceutical Co.,Ltd.).HPLC method was used.The chromatographic conditions were as follows.The chromatographic column was Agilent ZORBAX SB-Aq C_(18)(4.6 mm×250 mm,5μm).The proportion of mobile phase was methanol-36%acetic acid-water=25∶3∶72.The column temperature was set at 30℃,the wavelength was 247 nm,the flow rate was 0.6 ml/min,and the sample size was 10μl.The linearity,repeatability,durability,stability and recovery rate were investigated by methodology.Results There was a good linear relationship between puerarin and peak area in the concentration range of 5.31~50.59μg/ml,and the regression equation was y=0.4019x+0.3518,R^(2)=0.9997.The average value of 6 parallel samples was 6.92 mg/g,and RSD was 0.97%,indicating good repeatability.The change of sample content in 24 h was investigated by stability test,and RSD was 0.68%,indicating good stability.In the durability experiment,the content of puerarin was investigated under different flow rates,different column temperatures and different chromatographic column conditions,and RSD were 0.95%,0.63%and 1.21%,respectively,indicating good durability.The recovery rate test investigated the addition amount of different reference substances in three groups of low,medium and high,respectively.The average recovery rate was 97.16%and RSD was 0.90%,indicating good recovery rate.Three batches of samples were investigated,with five parallel samples in each batch.The results indicated that the average content determination of the three batches of samples was(6.90±0.01)mg/g,and there were neither significant differences in each batch and between batches.Conclusion This research method has high accuracy,strong reliability,high repeatability and sensitivity,which can be used to establish q uality standards.

关 键 词：HPLC法 葛根汤颗粒 葛根素 中药制剂 

分 类 号：R284[医药卫生—中药学]