肾茶饮片标准汤剂的质量标准研究  

Research on Quality Standard of Standard Decoction of Orthosiphon Stamineus Medicinal Slices

作　　者：梁永娟 覃小燕 陈清[2] 李芳婵 蒋林 林青华[1,2] LIANG Yong-juan;QIN Xiao-yan;CHEN Qing;LI Fang-chan;JIIANG Lin;LIN Qing-hua(College of Pharmacy,Guangxi University of Chinese Medicine,Nanning 530200,China;Guangxi Zhuang Yao Medicine Center of Engineering and Technology,Guangxi University of Chinese Medicine,Nanning 530200,China;Teaching Experiment and Training Center,Guangxi University of Traditional Chinese Medicine,Nanning 530200,China)

机构地区：[1]广西中医药大学药学院,广西南宁530200 [2]广西中医药大学广西壮瑶药工程技术研究中心,广西南宁530200 [3]广西中医药大学实验实训中心,广西南宁530200

出　　处：《食品与药品》2024年第4期295-300,共6页Food and Drug

基　　金：广西科技基地和人才专项(编号:桂科AD22035192);广西重点研发计划项目(编号:桂科AB21196051);广西高校中青年教师科研基础能力提升项目(编号:2021KY0303)。

摘　　要：目的 制备20批不同产地的肾茶饮片标准汤剂,并建立其质量标准。方法 按标准汤剂制备方法和要求,制备20批肾茶饮片的标准汤剂。考察其出膏率、迷迭香酸含量及其转移率,并建立高效液相色谱(HPLC)特征图谱。结果 20批肾茶饮片标准汤剂的出膏率、迷迭香酸含量及其转移率分别为18.42%~22.38%,2.3 0~8.0 3mg/g,36.89%~57.31%,拟定出膏率、迷迭香酸含量及转移率的标准分别为14.0%~27.0%,2.0~9.2 mg/g,31.0%~64.0%。HPLC特征图谱有7个共有峰,其中3个共有峰分别为咖啡酸、迷迭香酸和紫草酸,且特征图谱相似度均大于0.970。结论 本研究建立的肾茶饮片标准汤剂的质量标准准确、可靠,能为肾茶饮片配方颗粒及其相关制剂质量研究提供参考和依据。Objective To prepare twenty batches of standard decoction of Orthosiphon Stamineus medicinal slices collected from different origins and establish its quality standard.Methods Twenty batches of standard decoction of Orthosiphon Stamineus medicinal slices were prepared according to the preparation methods and requirements for standard decoction.The extraction rates and contents and transfer rates of rosmarinic acid were evaluated and the HPLC characteristic chromatogram was established.Results The extraction rates of twenty batches of standard decoction of Orthosiphon Stamineus medicinal slices and contents and transfer rates of rosmarinic acid were 14.0 %-27.0 %,2.0-9.2 mg/g,and 31.0 %-64.0 %,respectively.It was preliminarily proposed that the standards of extraction rate,content and transfer rate of rosmarinic acid were 14.0 %-27.0 %,2.0-9.2 mg/g,and 31.0 %-64.0 %,respectively.Seven common peaks were determined in the characteristic chromatogram and the peaks of caffeic acid,rosemary acid and purple oxalic acid were identified.The similarities of the peaks in the characteristic chromatogram were all higher than 0.970.Conclusion The established quality standard of standard decoction of Orthosiphon Stamineus medicinal slices was accurate and reliable,which can provide reference and basis for the quality research of formula granules and related preparations.

关 键 词：肾茶饮片 标准汤剂 迷迭香酸 特征图谱 质量标准 

分 类 号：R926[医药卫生—药学]