陈香露白露片多指标成分含量测定方法及指纹图谱的建立  

Establishment of the content determination method of multi-index components and fingerprint chromatography of Chenxiang Lubailu Tablets

作　　者：李华 张正悬 宋强 张贤达 袁璐 吴婷 李益丽 LI Hua;ZHANG Zheng-xuan;SONG Qiang;ZHANG Xian-da;YUAN Lu;WU Ting;LI Yi-li(Huangshi Food and Drug Inspection Center,Huangshi 435000,China)

机构地区：[1]黄石市食品药品检验检测中心,湖北黄石435000

出　　处：《时珍国医国药》2025年第3期478-482,共5页Lishizhen Medicine and Materia Medica Research

基　　金：湖北省药品监督管理局药品安全监管科研项目(20220117)。

摘　　要：目的建立适用于陈香露白露片HPLC多成分含量测定与指纹图谱方法。方法应用HPLC对17批陈香露白露片进行有效成分含量测定和指纹图谱建立,流动相为乙腈-甲醇-0.1%磷酸水,梯度洗脱,检测波长230nm。结果建立陈香露白露片的HPLC含量测定和指纹图谱的分析方法,甘草苷、橙皮苷、甘草酸铵、β-细辛醚、木香烃内酯、去氢木香内酯的专属性试验中峰分离度均大于1.5。对应指纹图谱与对照指纹图谱相似度良好,均大于0.9。结论建立陈香露白露片指纹图谱及6个成分的含量测定方法,简便准确可靠,可用于陈香露白露片的质量控制。Objective To establish a High Performance Liquid Chromatography(HPLC)method for determining the multi-component contents and fingerprint chromatography of Chenxiang Lubailu Tablet(CLT).Methods HPLC was used to determine the content of effective components and establish the fingerprints of 17 batches of CLT.The mobile phase was acetonitril-methanol-0.1%phosphoric acid water,gradient elution,and the detection wavelength was 230nm.Results The HPLC method was established to determine the contents and fingerprint analysis of CLT.The peak separations of liquiritin,hesperidin,ammonium glycyrrhizinate,β-asarum ether,costunolide and dehydrocostus lactone in the specific tests were all greater than 1.5.The similarity between the corresponding fingerprint and the control fingerprint was greater than 0.9.Conclusion The method of fingerprint and determination of six components of CLT is simple,accurate and reliable,which can be used for the quality control of CLT.

关 键 词：高效液相色谱法 陈香露白露片 多指标成分 指纹图谱 

分 类 号：R284.1[医药卫生—中药学]