抑肝散提取物的色谱指纹图谱及活性成分甘草酸的含量测定  

Chromatographic Fingerprint of YiGan Powder Extract and Determination of Active Ingredient Glycyrrhizic Acid

作　　者：朱泓檀 董振环 马潇 韩凌飞[1] 陈建荣 柳文媛[1] ZHU Hong-tan;DONG Zhen-huan;MA Xiao;HAN Ling-fei;CHEN Jian-rong;LIU Wen-yuan(Department of Pharmaceutical Analysis,China Pharmaceutical University,Nanjing 211198,China;Gansu Institute for Drug Control,Lanzhou 730070,China;NMPA Key Laboratory for Quality Control of Traditional Chinese Medicine(Chinese Materia Medica and prepared slices),Lanzhou 730070,China;Nantong Hospital of Integrated Traditional Chinese and Western Medicine,Nantong 226006,China)

机构地区：[1]中国药科大学药物分析系,江苏南京211198 [2]甘肃省药品检验研究院,甘肃兰州730070 [3]国家药品监督管理局中药材及饮片质量控制重点实验室,甘肃兰州730070 [4]南通市中西医结合医院,江苏南通226006

出　　处：《海峡药学》2023年第5期27-31,共5页Strait Pharmaceutical Journal

基　　金：基于多靶点和脑部转运的“抑肝散”抗老年痴呆效应物质及配伍机理的研究(国家自然科学基金No.81274064);国家药监局中药材及饮片质量控制重点实验室2022GSMPA-KL06,KL10。

摘　　要：目的建立抑肝散提取物的HPLC指纹图谱,探究其主要活性成分甘草酸的最佳提取条件并建立其含量测定的HPLC方法。方法指纹图谱测定采用ODS柱(250 mm×4.6 mm,5μm),以0.025%磷酸-乙腈为流动相梯度洗脱;在此基础上建立其中甘草酸的含量测定方法,并采用正交试验筛选了最佳的甘草酸样品前处理条件。结果抑肝散提取物HPLC指纹图谱共确立11个共有特征峰,并对特征色谱峰进行归属;比较了11批样品的指纹图谱,相似度大于0.9。方法学验证表明,甘草酸在50~500μg·mL-1内线性关系良好(r=0.9994),平均回收率为103.7%,RSD为2.46%(n=9)。结论建立的HPLC方法可用于抑肝散提取物色谱指纹图谱建立及其主要活性成分甘草酸的含量测定。OBJECTIVE To establish the HPLC fingerprint of YiGan Powder,and the method for determination of its major active ingredient Glycyrrhizic Acid and explore its optimum extraction condition from YiGan Powder Extract.METHODS Gradient elution was performed on an ODS column(250 mm×4.6 mm,5μm)with 0.025%phosphoric acid water and acetonitrile when establishing the fingerprint.On this basis,a method for determination of Glycyrrhizic Acid was established and its optimum pretreatment condition was screened by orthogonal test.RESULTS Totally 11 common peaks were calibrated in the HPLC fingerprint of YiGan Powder Extract and assignments of the characteristic peaks were presented.Fingerprints of 11 batches of samples were compared and the similarities were greater than 0.9.Additionally,Glycyrrhizic Acid showed good linearity at 50~500μg·mL-1(r=0.9994),the average recovery was 103.72%and RSD was 2.46%(n=9)according to the validation.CONCLUSION The HPLC methods can be used for the establishment of fingerprint of YiGan Powder Extract and determination of Glycyrrhizic Acid.

关 键 词：抑肝散提取物 高效液相色谱 指纹图谱 甘草酸 正交试验 

分 类 号：R284[医药卫生—中药学]