防己薏连丸质量标准研究  

Study on Quality Standard for Fangji Yilian Pills

作　　者：巩伟[1] 赵庆华[1] 王莉[1] 李鹏[1] 张琨[1] 

机构地区：[1]济南军区联勤部药品仪器检验所,济南2500022

出　　处：《中国药师》2014年第1期80-84,共5页China Pharmacist

摘　　要：目的：建立防己薏连丸的质量标准.方法：采用显微鉴别法鉴别苦杏仁、地黄、炒僵蚕;采用薄层色谱法鉴别薏苡仁、连翘、忍冬藤;采用高效液相色谱法测定粉防己碱、防己诺林碱以及连翘苷的含量.结果：显微鉴别法专属性强;薄层色谱法色谱特征明显,斑点清晰,分离度好;高效液相色谱法测定含量,粉防己碱、防己诺林碱、连翘苷分别在0.125 0～1.999 8 μg（r＝0.999 8）、0.062 4～0.997 9 μg（r＝0.999 8）、0.100 2～1.602 6 μg（r＝0.999 7）范围内有良好的线性关系,平均回收率分别为98.87%（RSD=0.71%,n=6）、100.19%（RSD=1.70%,n=6）、97.79%（RSD=1.72%,n=6）.结论：所建立的试验方法操作方便、结果准确、专属性强,可用于防己薏连丸的质量控制.Objective： To establish the quality standard for Fangji Yilian pills. Methods： Semen armeniacae amarum, rehmanniae Radix and fried bombyx batryticatus in the formula were identified under a microscope. Coicis semen, forsythia fructus and lonicerae ja- ponicae caulis in the formula were identified by TLC. The contents of tetrandrine, fangchinoline and phillyrin were determined by HPLC. Results： The microscopic images showed strong specificity. TLC had obvious characteristics with clear and well-separated spots. Tetrandrine showed a good linear relationship within the range of 0. 125 0-1. 999 8 μg（ r =0.999 8 ） with the average recovery of 98.87% （RSD = 0.71%, n = 6）, and angchinoline showed a good linear relationship within the range 0. 0624-0.997 9 μg（ r = 0. 999 8 ） with the average recovery of 100.19% （RSD = 1.70%, n = 6）, Phillyrin showed a good linear relationship within the range of 0. 100 2-1. 602 6μg（ r = 0. 999 7） with the average recovery of 97.79% （ RSD = 1.72%, n = 6 ）. Conclusion： The method is easy- operated and accurate with good specificity in the quality control of Fangji Yilian pills.

关 键 词：防己薏连丸 质量标准 显微鉴别法 薄层色谱法 高效液相色谱法 粉防己碱 防己诺林碱 连翘苷 

分 类 号：TQ460.72[医药卫生—药物分析学]