蒙药“古日古木-7”质量标准提升研究  

Improvement of Quality Standard of Mongolian Medicine“Gurigumu-7”

作　　者：孙欣缘 郑雅萍 孙康萌 李旻辉[4] 何春年[1,3] 肖培根[1,3] SUN Xinyuan;ZHENG Yaping;SUN Kangmeng;LI Minhui;HE Chunnian;XIAO Peigen(The Institute of Medicinal Plant Development,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100193,China;Anhui University of Chinese Medicine,Hefei 230012,China;Laboratory of Bioactive Substances and Resources Utilization of Chinese Herbal Medicine,Ministry of Education,Beijing 100193,China;Baotou Medical College,Baotou 014060,China)

机构地区：[1]中国医学科学院北京协和医学院药用植物研究所,北京100193 [2]安徽中医药大学,安徽合肥230012 [3]教育部中草药物质基础与资源利用重点实验室,北京100193 [4]包头医学院,内蒙古包头014060

出　　处：《中国现代中药》2025年第1期137-144,共8页Modern Chinese Medicine

基　　金：国家重点研发计划项目(2021YFE0190100);国家中医药多学科交叉创新团队项目(ZYYCXTD-D-202005);科学技术部科技基础资源调查专项(2022FY101000)。

摘　　要：目的:修订和完善“古日古木-7”药品标准,为合理控制“古日古木-7”类药品质量提供科学依据。方法:选择临床常用且现行质量评价标准较低的3种“古日古木-7”药品(德都红花七味丸/散、红花七味丸/散和清肝七味丸/散),分别收集和配伍21份代表性样品,以羟基红花黄色素A为指标建立含量测定方法,同时建立能够有效区分不同来源“古日古木-7”的化学特征指纹图谱。结果:3种“古日古木-7”药品中羟基红花黄色素A的质量分数分别为(5.26±0.32)、(4.97±0.94)、(5.21±0.26)mg·g^(-1),差异无统计学意义。建立的特征指纹图谱能够有效区分3种“古日古木-7”药品,其中德都红花七味丸/散特征图谱含有蓝盆花中的特征性成分秦皮乙素,红花七味丸/散含有菊花中的特征性成分木犀草苷和异鼠李素,2种药品均出现明显的诃子中鞣花酸成分的特征峰,而清肝七味丸/散中则没有鞣花酸成分的特征峰,除此以外,还多出香青兰和瞿麦的成分信息。结论:建立了能够同时快速准确测定3种“古日古木-7”药品中的羟基红花黄色素A含量,并规定了含量限度,有利于确保药品的基本质量,建立的特征图谱可以有效区分不同来源的“古日古木-7”药品,从而为“古日古木-7”类药品质量标准提高和临床合理用药提供参考。Objective:To revise and improve the drug standards of"Gurigumu-7"to provide a scientific basis for the reasonable control of the quality of"Gurigumu-7"drugs.Methods:Three types of"Gurigumu-7"(Dedu Honghua Qiwei Pills/Powder,Honghua Qiwei Pills/Powder,and Qinggan Qiwei Pills/Powder),which are commonly used in clinical practice and have relatively low quality evaluation standards,were selected.A total of 21 representative batches of samples were collected and combined.A content determination method was established using hydroxysafflor yellow A as the index,and the chemical fingerprint of"Gurigumu-7"from different sources was established.Results:The mass fraction of hydroxysafflor yellow A in the three"Gurigumu-7"drugs was(5.26±0.32),(4.97±0.94),and(5.21±0.26)mg·g^(-1),respectively,with no statistically significant difference.The established characteristic fingerprint can effectively distinguish the three types of"Gurigumu-7"drugs.The fingerprint of Dedu Honghua Qiwei Pills/Powder contains the characteristic component aesculetin from Scabiosa comosa,while the Honghua Qiwei Pills/Powder contains the characteristic components luteoloside and isorhamnetin from Chrysanthemi Flos.Both drugs show prominent characteristic peaks of ellagic acid from Chebulae Fructus.However,the Qinggan Qiwei Pills/Powder does not contain a characteristic peak for ellagic acid.In addition,more components were identified from Dracocephalum moldavica and Dianthi Herba.Conclusion:A method for the rapid and accurate determination of hydroxysafflor yellow A content in the three"Gurigumu-7"drugs was established,and content limits were set,which will help ensure the basic quality of the drugs.The established fingerprint can effectively distinguish different sources of"Gurigumu-7"drugs,providing a reference for improving the quality standard of"Gurigumu-7"class drugs and for rational clinical use of these drugs.

关 键 词：“古日古木-7” 质量标准 特征图谱 含量测定 德都红花七味丸/散 红花七味丸/散 清肝七味丸/散 

分 类 号：R282[医药卫生—中药学]