摘要
目的:建立益心泰颗粒的HPLC指纹图谱,为其质量评价提供依据。方法:采用Phenomenext Luna C_(18)色谱柱(250 mm×4.6 mm,5μm),以0.1%磷酸溶液-甲醇为流动相,检测波长为286 nm,体积流量为1.0 m L·min^(-1);柱温为30℃。测定10批益心泰颗粒样品,应用中药色谱指纹图谱相似度评价系统(2012版)建立益心泰颗粒指纹图谱共有模式图,并计算相似度,再通过对照品色谱图对共有峰进行指认。结果:通过10批样品的测定,建立益心泰颗粒HPLC指纹图谱,计算得相似度为0.98。共标定31个共有色谱峰,其中4个共有峰19、25、30、31号峰为黄芪药材的专属峰;7个共有峰3、20、21、22、23、24、28号峰为丹参的专属峰;9个共有峰6、7、11、12、13、14、26、27、29号峰为红花的专属峰;6个共有峰8、10、15-18号峰为葶苈子的专属峰;1个共有峰5号峰为泽泻专属峰;1、9号峰为红花、泽泻的共有峰,2号峰为红花、茯苓的共有峰,4号峰为猪苓、丹参的共有峰。并通过对照品色谱图对共有峰进行指认,12、19、21、25、30号峰分别为羟基红花黄色素A、毛蕊异黄酮苷、丹酚酸B、芒柄花素、毛蕊异黄酮。结论:10批样品相似度结果表明该颗粒制备工艺方法稳定可行,同时建立的HPLC指纹图谱方法稳定可靠。
Objective:To establish an HPLC method for fingerprint analysis of Yixintai granules for its quality control.Methods:The chromatographic behaviors were obtained by a Phenomenext Luna C_(18) column(250 mm×4.6 mm,5μm)with gradient elution using 0.1%phosphoric acid solution-methanol as the mobile phase.The detection wavelength was 286 nm,the volume flow rate was 1.0 mL·min^(-1),and the column temperature was 30℃.The samples of 10 batches of Yixintai granules were determined,the chromatographic fingerprint similarity evaluation system of Chinese medicine(2012 edition)was used to establish the common pattern of Yixintai granules fingerprints,and the similarity was calculated.Then the common peaks were identified by the reference chromatogram.Results:HPLC fingerprints of Yixintai granules were established by the determination of 10 batches of samples.The similarity was above 0.98.A total of 31 common peaks were calibrated.Four mutual peaks(No.15,25,30,31 peaks)were from Astragali Radix,seven mutual peaks(No.3,20,21,22,23,24,28 peaks)were from Salviae Miltiorrhizae Radix et Rhizom,nine mutual peaks(No.6,7,11,12,13,14,26,27,29 peaks)were from Carthami Flos,six mutual peaks(No.8,10,15-18 peakes)were from Descurainiae Semen.No.5 peak was form Alismatis Rhizoma.No.1,9 peaks were shared by Carthami Flos,and Alismatis Rhizoma,No.2 peaks was shared by Carthami Flos,and Poria,No.4 peaks was shared by Salviae Miltiorrhizae Radix et Rhizom.and Polyporus.The common peaks were all assigned to each medicinal material and identified by reference chromatograms:No.12,19,21,25,30 peaks were hydroxysafflor yellow A,calycosin 7-O-glucoside,salvianolic acid B,formononetin,calycosin.Conclusion:The similarity results of 10 batches of samples indicate that the particle preparation process is stable and feasible,and the established HPLC fingerprint method is stable and reliable.
作者
李雅
邹苏兰
易丽娟
李姿锐
郭志华
LI Ya;ZOU Su-lan;YI Li-juan;LI Zi-rui;GUO Zhi-hua(Hunan University of Chinese Medicine,Changsha 410208,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2021年第7期1155-1162,共8页
Chinese Journal of Pharmaceutical Analysis
基金
国家自然科学基金(81673955)
湖南省中医药科研计划项目重点课题(2020001)
湖南中医药大学一流学科建设项目(201803)。
关键词
益心泰颗粒
指纹图谱
质量控制
羟基红花黄色素A
毛蕊异黄酮苷
丹酚酸B
芒柄花素
毛蕊异黄酮
黄芪
丹参
红花
Yixintai granule
fingerprint
quality control
hydroxysafflor yellow A
calycosin 7-O-glucoside
salvianolic acid B
formononetin
calycosin
Astragali Radix
Salviae Miltiorrhizae Radix et Rhizom.
Carthami Flos
