中药饮片质量标志物（Q-marker）研究：莪术饮片质量评价研究及质量标准探讨  

Quality markers research on Chinese herbal pieces: Quality evaluation and quality standards of steamed and vinegar-processed pieces of Curcumae Rhizoma

作　　者：郝敏 童黄锦[2,4] 张季[4] 李金慈 苏联麟 费诚浩 顾薇[4] 陆兔林[4] 毛春芹[4] HAO Min;TONG Huang-jin;ZHANG Ji;LI Jin-ci;SU Lian-lin;FEI Cheng-hao;GU Wei;LU Tu-lin;MAO Chun-qin(College of Pharmaceutical Science,Zhejiang Chinese Medical University,Hangzhou 311402,China;Affiliated Hospital of Integrated Traditional Chinese and Western Medicine,Nanjing University of Chinese Medicine,Nanjing 210028,China;Pharmacy Department,National Clinical Research Center of Kidney Diseases,Jinling Hospital,Nanjing 210002,China;College of Pharmaceutical Science,Nanjing University of Chinese Medicine,Nanjing 210023,China)

机构地区：[1]浙江中医药大学药学院,浙江杭州311402 [2]南京中医药大学附属中西医结合医院,江苏南京210028 [3]东部战区总医院制剂科,江苏南京210002 [4]南京中医药大学药学院,江苏南京210023

出　　处：《中草药》2019年第19期4673-4682,共10页Chinese Traditional and Herbal Drugs

基　　金：国家重点研发计划(2018YFC1707000);国家自然科学基金资助项目(81673598);国家自然科学基金资助项目(81973483);国家中医药行业专项(2015468002-2);国家发改委中药饮片标准化建设项目(ZYBZH-Y-SC-40)

摘　　要：基于饮片质量标志物(Q-marker)的概念、确定标准及研究模式,以莪术饮片为例进行示范性研究,通过对生、醋莪术饮片化学物质组辨识明确化学物质基础及炮制前后发生显著变化的差异成分;结合药效、药性及药动学研究以及物质基础的相关性分析并做比较,明确其主要药效物质基础;综合研究结果,确定莪术二酮、莪术醇、吉马酮、呋喃二烯、β-榄香烯5个化学成分为质量标志物,建立生、醋莪术饮片多指标成分含量测定及指纹图谱控制方法。为中药饮片质量标志物的研究提供示范。A demonstration research on Chinese herbal decoction pieces of Curcumae Rhizoma was performed based on the concept of quality markers(Q-markers), standard establishment, and research modes. The chemical constituents of both steamed processed pieces of Curcumae Rhizoma and vinegar-processed pieces of Curcumae Rhizoma decoction pieces were identified by ultraperformance liquid chromatography/quadrupole-time of flight mass spectrometry(UPLC-Q/TOF-MS). The major effective components were analyzed through pharmacodynamics, drug property, pharmacokinetics studies, and correlation analysis of chemical constituents. The Q-markers were determined by all the results. At last, five compounds including curdione, curcumol, germacrone, furanodiene and β-elemene were selected as Q-markers. The quality control methods of multi-component assaying and fingerprint were also established. Overall, this study provides a demonstration for the study of quality markers of Chinese herbal decoction pieces.

关 键 词：生莪术 醋莪术 饮片 质量标志物 药效 多成分定量测定 饮片质量控制 莪术二酮 莪术醇 吉马酮 呋喃二烯 β-榄香烯 指纹图谱 

分 类 号：R284[医药卫生—中药学] R285[医药卫生—中医学]