淫羊藿药材及饮片质量分析与标准制定
投稿时间:2020-03-17     点此下载全文
引用本文:王常顺,段吉平,康帅,袁浩,刘永利,冯丽.淫羊藿药材及饮片质量分析与标准制定[J].中国现代中药,2020,22(7):1006-1015
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作者中文名作者英文名单位中文名单位英文名E-Mail
王常顺 WANG Chang-shun 河北省药品检验研究院/国家药品监督管理局中药材质量监测评价重点实验室,河北石家庄050227 Hebei Institute for Drug Control,NMPA Key Laboratory for Quality Monitoring and Evaluation of Traditional Chinese Medicine (Chinese Materia Medica),Shijiazhuang 050227,China  
段吉平 DUAN Ji-ping 河北省药品检验研究院/国家药品监督管理局中药材质量监测评价重点实验室,河北石家庄050227 Hebei Institute for Drug Control,NMPA Key Laboratory for Quality Monitoring and Evaluation of Traditional Chinese Medicine (Chinese Materia Medica),Shijiazhuang 050227,China  
康帅 KANG Shuai 中国食品药品检定研究院,北京100050 National Institut for Food and Drug Control,Beijing 100050,China  
袁浩 YUAN Hao 河北省药品检验研究院/国家药品监督管理局中药材质量监测评价重点实验室,河北石家庄050227 Hebei Institute for Drug Control,NMPA Key Laboratory for Quality Monitoring and Evaluation of Traditional Chinese Medicine (Chinese Materia Medica),Shijiazhuang 050227,China  
刘永利 LIU Yong-li 河北省药品检验研究院/国家药品监督管理局中药材质量监测评价重点实验室,河北石家庄050227 Hebei Institute for Drug Control,NMPA Key Laboratory for Quality Monitoring and Evaluation of Traditional Chinese Medicine (Chinese Materia Medica),Shijiazhuang 050227,China 刘永利,研究方向:中药质量标准;Tel:(0311)69086006,E-mail:liuyongli2008@126.com 
冯丽 FENG Li 河北省药品检验研究院/国家药品监督管理局中药材质量监测评价重点实验室,河北石家庄050227 Hebei Institute for Drug Control,NMPA Key Laboratory for Quality Monitoring and Evaluation of Traditional Chinese Medicine (Chinese Materia Medica),Shijiazhuang 050227,China 冯丽,研究方向:中药质量标准;Tel:(0311)69086156,E-mail:jianyan882@163.com 
基金项目:国家药品标准提高项目(2016-026)
中文摘要:目的:基于淫羊藿药材与饮片质量状况与统计分析,修订现行质量标准淫羊藿含量测定方法与限度。方法:采用HPLC建立以淫羊藿苷为参照的一标多测法(QAMS)测定淫羊藿中4种黄酮醇苷类成分的含量测定方法,对104批样品含量进行统计分析。结果:朝藿定A、朝藿定B、朝藿定C的相对保留时间分别为0.73、0.81、0.90,校正因子分别为1.35、1.28、1.22。聚类分析显示,朝鲜淫羊藿单独聚为一类,方差分析结果显示,朝鲜淫羊藿与心叶淫羊藿、柔毛淫羊藿P值均小于0.01,表明朝鲜淫羊藿总黄酮醇苷含量与其他3种基原差异有统计学意义。结论:建立的含量测定方法准确可靠、重复性好,根据品种特点单独制定限度,使新修订的质量标准更加科学、合理、可行。
中文关键词:淫羊藿  一标多测  淫羊藿苷  朝藿定A  朝藿定B  朝藿定C
 
Quality Analysis and Standard Formulation of Herba Epimedii and Decoction Pieces
Abstract:Objective:Based on the quality status and statistical analysis,to revise the determination method and quality standard of Herba Epimedii and decoction pieces. Methods:High performance liquid chromatography was used to develop a method for the determination of four flavonoid glycosides in Herba Epimedii with icariin as reference. The contents of 104 samples were analyzed statistically. Results:The relative retention time was respectively 0.73,0.81,0.90,the correction factors were respectively 1.35,1.28,1.22. Cluster analysis showed that Epimedium koreanum clustered into a single species. Variance analysis showed that the P between E. koreanum and E. pubescens and E. brevicornu were both less than 0.01,showed total flavone alcohol glycoside content of E. koreanum was significantly different from that of other three species. Conclusion:The established method is accurate,reliable and reproducible,and the revised quality standard is scientific and reasonable.
keywords:Herba Epimedii  QAMS  icariin  epimedin A  epimedin B  epimedin C
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