肾衰乙方颗粒质量控制研究  

Study on Quality Standards of Shenshuaiyi Granules

作　　者：程正 张冰冰 曹雅婷 郑如程 朱建勇 CHENG Zheng;ZHANG Bingbing;CAO Yating;ZHENG Rucheng;ZHU Jianyong(Tongling Food and Drug Inspection Center,Anhui Tongling 244061;Department of Nephrology,Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine,Shanghai 200137;Department of Pharmacy Research,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China)

机构地区：[1]铜陵市食品药品检验中心,安徽铜陵244061 [2]上海中医药大学附属第七人民医院肾病科,上海200137 [3]上海中医药大学附属岳阳中西医结合医院,上海200437

出　　处：《广州化工》2025年第4期50-55,100,共7页GuangZhou Chemical Industry

基　　金：上海市科学技术委员会(No:23015821100);上海市卫生健康委员会科研项目(No:202340074);上海市浦东新区卫生健康委员会中医药科技创新项目(No:PDZY-2018-0801)。

摘　　要：通过薄层色谱法对肾衰乙方颗粒中的制大黄、徐长卿、土茯苓、陈皮、黄芪予以定性鉴别,同时运用高效液相色谱法测定其中大黄素、芦荟大黄素、落新妇苷及橙皮苷的含量,以此建立该复方颗粒的质量控制方法。薄层鉴别分离佳、专属性强、无阴性干扰;高效液相色谱测定中,各成分线性关系良好,加样回收率高,RSD低。建立的方法具备准确性高、专属性强、操作简易的优势,能够作为肾衰乙方颗粒的质量控制手段。The qualitative identification of Radix et Rhizoma Rhei Praeparata,Cynanchum paniculatum,Smilax glabra,Pericarpium Citri Reticulatae and Astragalus membranaceus in Shenshuaiyi Granules was carried out by thin-layer chromatography.Meanwhile,the contents of emodin,aloe-emodin,astilbin and hesperidin were determined by high-performance liquid chromatography,so as to establish the quality control method for this compound granule.The thin-layer identification had good separation,strong specificity and no negative interference.In the determination of high-performance liquid chromatography,each component had a good linear relationship,high sample recovery rate and low RSD.In conclusion,the established method had the advantages of high accuracy,strong specificity and simple operation,and can be used as the quality control means for Shenshuai Yifang Granules.

关 键 词：肾衰乙方颗粒 薄层色谱 高效液相色谱 芦荟大黄素 大黄素 落新妇苷 橙皮苷 

分 类 号：R917[医药卫生—药物分析学]