生芪消渴胶囊UPLC指纹图谱建立及6种成分含量测定  

Establishment of UPLC fingerprint and determination of six components of Shengqi Xiaoke Capsules

作　　者：李莉娜 杨淑婷 杨健[1,2] 陆苑 李勇军[4,2] 王永林 LI Li-na;YANG Shu-ting;YANG Jian;LU Yuan;LI Yong-jun;WANG Yong-lin(Guizhou Provincial Key Laboratory of Pharmaceutics;School of Pharmacy;Engineering Research Center for the Development and Application of Ethnic Medicine and TCM,Ministry of Education;National Engineering Research Center of Miao＇s Medicines,Guizhou Medical University,Guiyang 550004,China)

机构地区：[1]贵州医科大学贵州省药物制剂重点实验室,贵阳550004 [2]贵州医科大学药学院,贵阳550004 [3]贵州医科大学国家苗药工程技术研究中心,贵阳550004 [4]贵州医科大学民族药与中药开发应用教育部工程研究中心,贵阳550004

出　　处：《中国新药杂志》2018年第18期2196-2202,共7页Chinese Journal of New Drugs

基　　金：贵州省中药现代化科技产业研究开发专项资助项目(黔科合中药字[2012]5037号);贵州省民族药与中药开发应用工程技术研究中心资助项目(黔科合重G字[2013]4001);民族药与中药开发应用产学研基地建设资助项目(黔科合KY字[2013]122);药剂学研究生卓越人才计划资助项目(黔教研合ZYRC字[2014]012)

摘　　要：目的:建立生芪消渴胶囊UPLC指纹图谱,并同时测定6种指标成分的含量,为生芪消渴胶囊的质量控制研究提供参考依据。方法:通过超高液相色谱仪(UPLC),采用Agilent Eclipse Plus C18RRHD色谱柱(150 mm×2.1 mm,1.8μm);以0.1%甲酸水-0.1%甲酸甲醇溶液为流动相,梯度洗脱;检测波长为280 nm;流速为0.25 mL·min^(-1);柱温45℃。采用国家药典委员会出版的"中药色谱指纹图谱相似度评价系统"(2012年版),建立10批生芪消渴胶囊指纹图谱,并使用UPLC法同时测定6种指标成分含量。结果:10批生芪消渴胶囊的指纹图谱相似度均大于0.99,标定了15个共有峰,各峰分离度较好。指认了其中6个共有峰,分别为丹参素钠、原儿茶醛、毛蕊异黄酮葡萄糖苷、迷迭香酸、丹酚酸B、丹酚酸A。经方法学考察,6种指标成分在一定浓度范围内线性良好,平均加样回收率良好,精密度RSD值均小于2%,且重复性与稳定性良好。结论:建立的UPLC指纹图谱分析方法与多指标成分测定方法灵敏准确、专属性强,有利于生芪消渴胶囊进一步的质量控制研究。Objective： To establish the UPLC fingerprint of Shengqi Xiaoke Capsules and determine the contents of six kinds of index components simultaneously to provide reference for the quality control of Shengqi Xiaoke Capsules. Methods： Agilent Eclipse Plus C18 RRHD column（ 150 mm × 2. 1 mm,1. 8 μm） was chosen with 0. 1% formic acid water-0. 1% formic acid methanol solution as mobile phase. Gradient elution was performed at a flow rate of 0. 25 mL·min^-1. The detection wavelength was 280 nm and the column temperature was 45 ℃.The chromatographic fingerprint evaluation system published by the State Pharmacopoeia Commission（ 2012 Edition） was used to establish the fingerprint of 10 batches of Shengqi Xiaoke Capsules,and the contents of sixkinds of index components were determined simultaneously by the established UPLC method. Results： The similarities of the 10 batches of Shengqi Xiaoke Capsules were more than 0. 99,and 15 common peaks were calibrated,and the resolution of each peak was good,and 6 common peaks were identified,which were salvia miltiorrhiza sodium,protocatechuic aldehyde,pistil isoflavone glucoside,rosmarinic acid,salvianolic acid B,and salvianolic acid A.The calibration curves of the 6 index components showed good linearity in a certain concentration range,the average recovery rate was good,the precision RSD values were less than 2%,and the repeatability and stability were satisfying.Conclusion： The established UPLC fingerprinting analysis method and multi-index components determination method are sensitive,accurate,specific,which is conducive to further quality control of Shengqi Xiaoke Capsules.

关 键 词：生芪消渴胶囊 超高液相色谱仪 指纹图谱 含量测定 

分 类 号：R917[医药卫生—药物分析学]