仙灵密骨颗粒质量标准的研究  

Study on quality standard of Xianling Migu Granules

作　　者：刘群 邱少华 林晓 LIU Qun;QIU Shaohua;LIN Xiao(Shandong Institute for Food and Drug Control,Jinan 250101,China;Linyi Inspection and Testing Center,Linyi 276000,China)

机构地区：[1]山东省食品药品检验研究院,山东济南250101 [2]临沂市检验检测中心,山东临沂276000

出　　处：《药学研究》2019年第9期520-524,共5页Journal of Pharmaceutical Research

摘　　要：目的建立仙灵密骨颗粒的质量标准。方法采用薄层色谱(TLC)法对颗粒中鸡血藤、淫羊藿、骨碎补、续断、千年健进行定性鉴别;采用高效液相色谱(HPLC)法测定淫羊藿苷的含量。结果建立的仙灵密骨颗粒中鸡血藤、淫羊藿、骨碎补、续断、千年健的薄层色谱鉴别方法具有良好的专属性;淫羊藿苷在0.015 84~0.079 20 mg·mL^-1范围内呈良好的线性关系(r=0.999 9),平均回收率为98.84%(RSD为1.37%)。结论建立的定性及定量方法可以有效地控制本品的内在质量。Objective To establish the quality standard for Xianling Migu Granules.Methods Spatholobi Caulis,Epimedii Folium,Drynariae Rhizoma,Dipsaci Radix and Homalomenae Rhizoma in Granules were identified by TLC;The content of icarrin was determined by HPLC.Results By TLC,the spots of five herbal drugs in Granules were well separated and the negative control samples had no interference;The calibration curve of icarrin showed a good linearity in the range of 0.015 84~0.079 20 mg·mL^-1(r=0.999 9),and the average recovery was 98.84%with RSD 1.37%.Conclusion This established method was accurate,reliable and specific,it can be used for the quality control of Xianling Migu Granules.

关 键 词：仙灵密骨颗粒 薄层色谱 高效液相色谱法 淫羊藿苷 质量标准 

分 类 号：R927.11[医药卫生—药学]