十二味阿胶膏质量标准研究  

Study on Quality Control of Shierwei Ejiao Gao

作　　者：谢若男[1] 杨满琴[1] 王丽[1] 徐玥玮[1] 高晓明[1] 韩明辰 高玉菊 XIE Ruonan;YANG Manqin;WANG Li;XU Yuewei;GAO Xiaoming;HAN Minchen;GAO Yuju(The Second Affiliated Hospital of Anhui University of Chinese Medicine,Hefei 230061,China)

机构地区：[1]安徽中医药大学第二附属医院,安徽合肥230061

出　　处：《中医药临床杂志》2018年第11期2153-2156,共4页Clinical Journal of Traditional Chinese Medicine

基　　金：安徽省中医发展专项资金项目(2016ZYZJ02)

摘　　要：目的:建立十二味阿胶膏质量控制方法。方法:采用薄层色谱法对十二味阿胶膏中黄芪、枸杞子、枳壳进行定性鉴别研究,采用HPLC法测定柚皮苷的含量,色谱条件为SHIMPACKODSC18柱(4.6×150mm,5μm);流动相:甲醇-0.5%醋酸溶液(36:64);柱温:40℃;流速:1.0ml/min;检测波长:283nm。采用定氮仪法测定十二味阿胶膏中氮的含量。结果:在薄层色谱中黄芪、枸杞子、枳壳的斑点清晰可见,且分离度良好,阴性无干扰。柚皮苷在0.03935-0.3935μg/mL范围内线性关系良好,平均加样回收率为96.67%(RSD=1.50%)。每克十二味阿胶膏含总氮量不得少于10.0mg。结论:所建立的方法合理,稳定,可用于十二味阿胶膏的质量控制。Objective To establish a method for quality control of Shierwei Ejiao Gao.Methods Thequalitative identification of Astragali radix,Lycii fructus,Aurantii fructusin Shierwei Ejiao Gao was performed by thin-layer chromatography (TLC ),high-performance liquid chromatography were used for qualitative identification and content determination of naringinin Shierwei Ejiao Gao,HPLC was performed on a SHIMPACK ODS C18 column (4.6×150mm,5μm)with a mobile phase of methanol-0.5%acetic acid(36:64);at a column temperature of 40℃,a flow rate of 1.0mL/min,and a wave length of 283nm.The content of nitrogen in Shierwei Ejiao Gao was determined by azotometer method. Results The TLC spots of were clear without interference from the negative control.A good linear relationship with peak area was achieved when the concentrations of naringin ranged within 0.03935-0.3935μg/mL,and the average recovery rates was 96.67%,with relative standard deviation of 1.50%.Conclusion The establish method is reasonable and stable for quality control of Shierwei Ejiao Gao.

关 键 词：十二味阿胶膏 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R927.1[医药卫生—药学]