射干地龙颗粒质量标准  

Quality Standard of Shegan Dilong Granules

作　　者：辛蕊华[1] 谢家声[1] 郑继方[1] 罗永江[1] 

机构地区：[1]中国农业科学院兰州畜牧与兽药研究所/农业部兽用药物创制重点实验室/甘肃省新兽药工程重点实验室/甘肃省中兽药工程技术研究中心,兰州730050

出　　处：《中国实验方剂学杂志》2013年第13期57-60,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金："十二五"国家科技支撑计划项目(2011BAD34B03);公益性行业(农业)科研专项(201303040-18)

摘　　要：目的:建立射干地龙颗粒的质量标准,为其质控提供依据。方法:采用薄层色谱法对组方中药材进行定性鉴别,采用高效液相色谱法测定组方中次野鸢尾黄素的含量。结果:确定了制剂中射干、地龙、北豆根及五味子的薄层鉴别方法,在选定的薄层色谱条件下,色谱斑点分离较好;采用C18反相柱,以乙腈-0.2%磷酸水为流动相,检测波长为266 nm,建立了本制剂中次野鸢尾黄素的含量测定方法,得到其线性为0.342 2～86.60 mg.L-1,回归方程为A=51 639C+7 222(R2=0.999 5,n=10)。平均回收率为99.04%,RSD 1.27%。结论:所建立的方法简便、准确、专属性强、重复性好,可有效地控制射干地龙颗粒的质量。Objective： To establish a quality standard of Shegan Dilong Granules for scientific evaluation and effective control of its quality to provide a reliable basis.Method： TLC was used for identifying the herbs in the formula and the content determination of irisflorentin by HPLC was also revised.Result： The method was established to distinguish Belamcanda sinensis,pberetima,rhizome Menispermi and Schisandra chinensis.The spots in the TLC were clear,and with no interference from negative control.The HPLC separation was performed on C18 column,the mixture of acetonitrile-0.2% phosphoric acid water was used as mobile phase.The detection wavelength was set at 266 nm,irisflorentin was linear in the range of 0.342 2-86.60 mg.L-1;regression equation was A = 51 639C ＋ 7 222（R2 = 0.999 5,n = 10）;the average recovery was 99.8%,RSD 1.50%.Conclusion： The method was simple and accurate with a good reproducibility,and can be used for the control of Shegan Dilong Granules.

关 键 词：射干地龙颗粒 薄层鉴别 高效液相色谱法 质量标准 次野鸢尾黄素 

分 类 号：R284.1[医药卫生—中药学]