摘要
目的:建立益气健骨颗粒HPLC指纹图谱与一测多评(quantitative analysis of multicomponents by singlemaker,QAMS)含量测定研究方法。方法:以80%甲醇制备益气健骨颗粒供试品溶液,采用HPLC法建立指纹图谱,并对其中8个成分进行指认。以柚皮苷为内参物,建立同时测定7种成分的QAMS法。结果:建立了益气健骨颗粒HPLC指纹图谱,共标定15个共有峰,并对其中的没食子酸、莫诺苷、獐牙菜苷、马钱苷、芍药苷、柚皮苷、盐酸巴马汀、盐酸小檗碱的8个成分进行指认。不同批次指纹图谱与对照图谱进行相似度评价结果显示,相似度为0.994~0.999;8个成分在相应的浓度范围内线性关系良好(r>0.9990),平均加样回收率为95.03%~102.26%,RSD为0.84%~1.97%;不同设备、色谱柱、柱温、进样体积、流速等色谱条件下耐用性良好,与外标法相比较,以柚皮苷为内参物的QAMS法对其余7个成分的测定结果无显著性差异。结论:建立的HPLC指纹图谱结合QAMS法准确可靠,可为益气健骨颗粒的质量评价提供参考依据。
OBJECTIVE To establish a method for the determination of the contents of Yiqi Jiangu Granules by high-performance liquid chromatography(HPLC)fingerprint and quantitative analysis of multi-components by a single maker(QAMS).METHODS Fingerprints were established by HPLC using 80%methanol extraction of the test solution of Yiqi Jiangu Granules,and eight components were identified.Using naringin as an internal standard reference,QAMS was established for the simultaneous determination of seven components.RESULTS HPLC fingerprints of Yiqi Jiangu Granules were established,and 15 common peaks were identified.The eight components,including gallic acid,monensin,swertiamarin,strychno-side,paeoniflorin,naringin,palmatine hydrochloride and berberine hydrochloride were identified.The fingerprints of different batches of Yiqi Jiangu Granules were evaluated for similarity with the control profiles.The results showed that the similarity ranged from 0.994 to 0.999.Eight components showed good linearity(r>0.9990)in the corresponding concentration ranges,with average recoveries of 95.03%-102.26%,and the relative standard deviation(RSD)of 0.84%-1.97%.The durability of the chromatographic conditions,such as different equipments,columns,column temperatures,injection volumes and flow rates were good.There were no significant differences in the contents of the remaining 7 components with naringin as the internal reference detected by the external standard method versus QAMS.CONCLUSION The established HPLC fingerprints combined with QAMS method are accurate and reliable,which can provide a reference basis for the quality evaluation of Yiqi Jiangu Granules.
作者
李璧竹
徐文杰
李智勇
陈雪婷
雪奕怡
王思丰
陈泳琳
张建军
冯健英
LI Bizhu;XU Wenjie;LI Zhiyong;CHEN Xueting;XUE Yiyi;WANG Sifeng;CHEN Yonglin;ZHANG Jianjun;FENG Jianying(The Fifth Clinical Medical School of Guangzhou University of Chinese Medicine,Guangdong Guangzhou 510095,China;Guangdong Second Traditional Chinese Medicine Hospital(Guangdong Province Engineering Technology Research Institute of TCM)/Guangdong Provincial Key Laboratory of Research and Development in Traditional Chinese Medicine,Guangdong Guangzhou 510095,China)
出处
《中国医院药学杂志》
北大核心
2025年第12期1386-1392,共7页
Chinese Journal of Hospital Pharmacy
基金
广东省科技计划项目“创新中药研发平台建设”(编号:2017A070701017)。
关键词
益气健骨颗粒
指纹图谱
一测多评
含量测定
Yiqi Jiangu Granules
fingerprint
quantitative analysis of multi-components by singlemaker(QAMS)
content determination
作者简介
李璧竹,女,在读硕士研究生,研究方向:中药制剂及药效物质基础;通信作者:李智勇,男,博士,主任中药师,硕士研究生导师,研究方向:中药制剂及药效物质基础。
