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复方仙灵脾颗粒质量标准研究
引用本文:贾辉,马宏达,胡北,吴琼,史国兵. 复方仙灵脾颗粒质量标准研究[J]. 辽宁中医药大学学报, 2014, 0(12): 51-53
作者姓名:贾辉  马宏达  胡北  吴琼  史国兵
作者单位:中国人民解放军沈阳军区总医院药剂科
基金项目:军队医疗机构制剂标准提高科研专项课题(13ZJZ02)
摘    要:目的:建立复方仙灵脾颗粒的质量控制方法。方法:采用TLC法对方中淫羊藿、枸杞子进行鉴别;采用HPLC法测定样品中淫羊藿苷的含量。色谱条件:色谱柱为Welchrom C18柱(200 mm×4.6 mm,5μm);流动相:乙腈-水(25∶75);流速为1.0 m L/min;检测波长:270 nm;柱温:30℃。结果:薄层定性鉴别的斑点清晰,分离效果良好;淫羊藿苷含量在3~160μg/m L范围内线性关系良好(r=0.9998),平均加样回收率为100.20%,RSD为2.55%(n=6)。结论:本方法结果准确、操作简单,重复性良好,适合作为该制剂的质量控制标准。

关 键 词:复方仙灵脾颗粒  质量标准  淫羊藿苷  HPLC  TLC

Quality Standard for Fufang Xianlingpi Granule
JIA Hui,MA Hongda,HU Bei,WU Qiong,SHI Guobing. Quality Standard for Fufang Xianlingpi Granule[J]. Journal of Liaoning University of Traditional Chinese Medicine, 2014, 0(12): 51-53
Authors:JIA Hui  MA Hongda  HU Bei  WU Qiong  SHI Guobing
Affiliation:( Department of Pharmacy, General Hospital of Shenyang Military Command Area, Shenyang 110016, Liaoning, China )
Abstract:Objective : To establish a quality standard for Fufang Xianlingpi Granule. Methods : Epimedii folium and Lycii fructus were identified by TLC method. The content of ieariin in Fufang Xianlingpi Granule was determined by HPLC. The Welehrom C18 (200 mm×4.6 mm,5μm)column was used. The mobile phase consisted of acetonitrile-water ( 25 : 75 ) at a flow rate of 1.0 mL/min. The detection wavelength was at 270 nm under 30 ℃ . Results : The spots in the thin layer chromatography were clear. The icariin showed a good linear relationship within the range of 3-160 μg/mL (r=0.9998). The average recovery was 100.20%, and the RSD was 2.55%. Conclusion : The method is simple, accurate and repeatable, which can be used for quality control of Fufang Xianlingpi Granule.
Keywords:Fufang Xianlingpi Granule  quality standard  icariin  HPLC  TLC
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