小儿解感颗粒HPLC指纹图谱及3种成分含量测定研究  

HPLC fingerprint and determination of three components of Xiaoer Jiegan granules

作　　者：董宠 陈斌[1] 许龙[1] 曹阳 黄顺旺 曹明成[1] DONG Chong;CHEN Bin;XU Long(Hefei Innovative Pharmaceutical Technology Co.,Ltd.,Hefei 230088,Anhui)

机构地区：[1]合肥创新医药技术有限公司,安徽合肥230088

出　　处：《安徽医专学报》2023年第4期86-88,138,共4页Journal of Anhui Medical College

摘　　要：目的:建立小儿解感颗粒的指纹图谱高效液相色谱条件并以该方法同时测定黄芩苷、甘草苷和甘草酸的含量,为其质量评价提供科学依据。方法:以Agilent 5 HC C18色谱柱,流动相乙腈(A)-0.1%甲酸水溶液(B),梯度洗脱;检测波长270 nm,流速1.0 mL·min^(-1),柱温35℃,进样量10μL。结果:HPLC指纹图谱共标定23个共有峰,其中9号峰为甘草苷,14号峰为黄芩苷,20号峰为甘草酸,其特征信息与相应的对照品相吻合。含量测定结果,甘草苷、黄芩苷和甘草酸浓度分别在0.021~0.41 mg·mL^(-1)、0.10~2.01 mg·mL^(-1)、0.0075~0.15 mg·mL^(-1)内与峰面积呈良好的线性关系,且稳定性、重复性、精密度的RSD均小于3.0%,加样回收率在100.01%~100.78%。10批次样品含量测定,甘草苷为4.82~5.21 mg·g-1,黄芩苷为24.38~26.34 mg·g-1,甘草酸为1.46~1.70 mg·g-1。结论:该方法灵敏度高、稳定性好,数据准确可靠,基本体现了小儿解感颗粒的整体化学成分特征,可用于该药品的质量控制,为小儿解感颗粒质量的评价提供依据。Objective:To establish an HPLC conditions for the fingerprinting of Xiao'er Jiegan granules and to determine the contents of baicalin,glycyrrhizin and glycyrrhetinic acid simultaneously,providing a scientific basis for quality evaluation.Methods:HPLC was performed on Agilent 5 HC C18 column with mobile phase consisting of acetonitrile(A)-0.1%formic acid solution(B)and gradient elution.The detection wavelength was 270nm,flow rate at 1.0 mL·min^(-1),column temperature 35℃,sample volume 10μL.Results:A total of 23 common peaks were identified by HPLC fingerprint,among which peak No.9 was baicalin,peak No.14 was glycyrrhizin,and peak No.20 was glycyrrhetinic acid,with their characteristic information matching the corresponding reference.The methodological validation of the content determination showed that the concentrations of glycyrrhizin,baicalin and glycyrrhetinic acid showed good linear relationships with the peak areas within 0.021~0.41,0.10~2.01 and 0.0075~0.15 mg·mL^(-1),respectively.The RSD of stability,repeatability and precision were all less than 3.0%,and the recovery rate of spiked samples was between 100.01%and 100.78%.The results of content determination of 10 batches of samples were 4.82~5.21mg·g-1 for glycyrrhizin,24.38~26.34mg·g-1 for baicalin and 1.46~1.70mg·g-1 for glycyrrhetinic acid.Conclusion:The method has high sensitivity,good stability,accurate and reliable data,and basically reflects the overall chemical composition characteristics of Xiao'er Jiegan granules.It can be used for the quality control of the drug,and provides the test basis for the evaluation of the quality of Xiao'er Jiegan granules.

关 键 词：小儿解感颗粒 指纹图谱 含量测定 质量控制 HPLC 

分 类 号：R286[医药卫生—中药学]