黄蛭益肾胶囊质量标准的提升  

Improvement of Quality Standard for Huangzhi Yishen Capsules

作　　者：钱叶飞 陆林玲 张超 薛启梅 郭青 闵春艳 Qian Yefei;Lu Linling;Zhang Chao;Xue Qimei;Guo Qing;Min Chunyan(Suzhou Institute for Drug Control,Jiangsu Suzhou 215104,China;Jiangsu Institute for Food and Drug Control;Nanjing University of Chinese Medicine)

机构地区：[1]苏州市药品检验检测研究中心,江苏苏州215104 [2]江苏省食品药品监督检验研究院 [3]南京中医药大学

出　　处：《中国药师》2022年第10期1820-1825,共6页China Pharmacist

基　　金：国家药典委员会药品标准制修订研究课题(编号:2019Z040)。

摘　　要：目的:提升黄蛭益肾胶囊的质量标准。方法:采用薄层色谱(TLC)法对黄蛭益肾胶囊中的枸杞子、牛膝和车前子进行定性鉴别;采用HPLC-DAD法同时测定毛蕊异黄酮葡糖苷、刺芒柄花苷、毛蕊异黄酮、芒柄花黄素的含量,采用HPLC-ELSD法测定黄芪甲苷的含量。结果:枸杞子、牛膝和车前子的薄层斑点清晰,分离良好,阴性无干扰。毛蕊异黄酮葡萄糖苷、刺芒柄花苷、毛蕊异黄酮、芒柄花素、黄芪甲苷分别在1.03~20.52μg·ml^(-1),0.89~17.72μg·ml^(-1),1.51~30.24μg·ml^(-1),1.03~20.62μg·ml^(-1),67.62~563.52μg·ml^(-1)(r=0.9996~1.0000)浓度范围内线性关系良好;平均加样回收率分别为93.4%,93.0%,100.7%,91.4%,99.5%,RSD分别1.53%,1.73%,1.46%,1.23%,1.85%(n=6)。结论:建立的TLC法专属性强、灵敏度高,HPLC法简便可行,结果准确、可靠,重复性、稳定性好,可用于黄蛭益肾胶囊的质量控制。Objective:To improve the quality standard for Huangzhi Yishen capsules.Methods:Lycii Fructus,Achyranthis Bidentatae Radix and Plantaginis Semen in Huangzhi Yishen capsules were identified by TLC.The contents of calycosin 7-O-β-D-glucopyranoside,ononin,calycosin and formononetin were determined by HPLC with a DAD detector,and the content of astragalosideⅣwas tested with an evaporative light-scattering detector(ELSD).Results:The TLC characteristic spots of Lycii Fructus,Achyranthis Bidentatae Radix and Plantaginis Semen were clear and the negative control had no interference.The linear ranges of calycosin7-O-β-D-glucopyranoside,ononin,calycosin,formononetin and astragalosideⅣwere(1.03-20.52),(0.39-7.80),(1.51-30.24),(1.03-20.62)and(6.35-563.52)μg·ml^(-1)(r=0.9996-1.0000),respectively.The average recovery was 93.4%,93.0%,100.7%,91.4%and 99.5%with the corresponding RSDs of 1.53%,1.73%,1.46%,1.23%and 1.85%(n=6),respectively.Conclusion:The established TLC method has strong specificity and high sensitivity,and the HPLC methods are simple,feasible,accurate and reliable with good repeatability and stability,which can be used for the quality control of Huangzhiyishen capsules.

关 键 词：黄蛭益肾胶囊 质量标准 毛蕊异黄酮葡糖苷 刺芒柄花苷 毛蕊异黄酮 芒柄花黄素 黄芪甲苷 

分 类 号：TQ460.72[医药卫生—药物分析学]