清胃散基准样品HPLC指纹图谱的建立及关键成分的量值传递分析  

Establishment of HPLC fingerprint of Qingwei Powder benchmark samples and quantity value transfer analysis of key components

作　　者：朱仁愿 续艳丽 丁辉 刘兴国 蒲玉红[4] 刘国华[4] 李坚 ZHU Renyuan;XU Yanli;DING Hui;LIU Xingguo;PU Yuhong;LIU Guohua;LI Jian(Lanzhou Institute for Food and Drug Control,Lanzhou 730050,China;Gansu Engineering Research Center for Monitoring Exogenous Harmful Residues in Traditional Chinese Medicines,Lanzhou 730050,China;Gansu University of Chinese Medicine,Lanzhou 730099,China;Lanzhou University Second Hospital,Lanzhou 730030,China)

机构地区：[1]兰州市食品药品检验检测研究院,兰州730050 [2]甘肃省种植中药材外源性污染物监测工程研究中心,兰州730050 [3]甘肃中医药大学,兰州730099 [4]兰州大学第二医院,兰州730030

出　　处：《中华中医药杂志》2024年第6期3044-3053,共10页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家市场监督管理总局科技计划项目(No.2021MK110);甘肃省自然科学基金项目(No.21JR1RA169);甘肃省自然科学基金实验动物专项(No.22JR5RA1060);兰州市科技计划项目(No.2021-1-185)。

摘　　要：目的:建立清胃散基准样品的指纹图谱及关键成分含量测定方法,并分析量值传递规律。方法:依据古籍制备18批清胃散基准样品冻干粉,采用HPLC法建立指纹图谱及关键成分含量测定方法,以出膏率、指纹图谱相似度,指标成分含量和转移率评价清胃散基准样品的质量。结果:18批清胃散基准样品的指纹图谱相似度良好(≥0.984),26个共有峰中指认出10个峰,主成分分析显示盐酸小檗碱、异阿魏酸、阿魏酸、山柰酚、儿茶素和藁本内酯是其特征成分。10个指标成分在各自范围内线性关系良好(r≥0.9956),精密度、稳定性、重复性试验的RSD均小于3%,平均加样回收率为99.6%~113.3%,RSD为0.13%~5.28%(n=6),转移率为5%~64%。结论:清胃散基准样品的质量稳定性、可靠性和一致性良好,可为清胃散复方制剂开发和质量控制提供参考。Objective:To established the method of fingerprint and key components content determination of Qingwei Powder benchmark samples,and the quantity value transfer was analyzed.Methods:A total of 18 batches of Qingwei Powder benchmark samples were prepared according to the ancient book method.HPLC method was used to establish fingerprint and index component content determination method.The quality of Qingwei Powder benchmark samples was evaluated by paste yield,fingerprint similarity,index component content and transfer rate.Results:The fingerprint of 18 batches of Qingwei Powder benchmark samples had good similarity(≥0.984),and 10 of the 26 common peaks were identified.Principal component analysis showed that berberine hydrochloride,isoferulic acid,ferulic acid,kaempferol,catechin,ligustilide were the characteristic components of Qingwei Powder benchmark samples.10 index components had good linearity in their respective ranges(r≥0.9956),RSD of precision,stability and repeatability tests were all less than 3%,the average recoveries were 99.6%-113.3%,RSD were 0.13%-5.28%(n=6),and the transfer rates 5%-64%.Conclusion:The quality stability,reliability and consistency of Qingwei Powder benchmark samples was good,it can provide reference for the development and quality control of Qingwei Powder compound preparation.

关 键 词：清胃散 基准样品 指纹图谱 含量测定 量值传递 

分 类 号：R284.1[医药卫生—中药学]