龟鹿补肾丸的质量控制  

Study on the Quality Control of Guilu Bushen Pills

作　　者：李文静[1] 刘洁琼[1] 李坤杰[1] 秦峰[1] 李发美[1] 

机构地区：[1]沈阳药科大学院药学院,沈阳110016

出　　处：《中国药师》2009年第9期1273-1275,共3页China Pharmacist

基　　金：<中国药典>2010年版一部标准研究课题(编号ZN-341)

摘　　要：目的:建立龟鹿补肾丸的定性鉴别和定量测定方法。方法:采用TLC法对龟鹿补肾丸进行定性鉴别:用HPLC法测定该制剂中淫羊藿苷的含量。结果:薄层色谱法可鉴别出该制剂中的陈皮、黄芪、酸枣仁和淫羊藿。HPLC法含量测定中,淫羊藿苷的浓度在1～30μg·ml^(-1)范围内呈良好线性,样品的平均加样回收率为99.87%,RSD为2.5%。结论:建立的定性和定量方法均具有专属性好、准确和可靠的特点,可作为该制剂的质量控制方法。Objective： To establish the qualitative and quantitative methods for quality control of guilu bushen pills. Method： The qualitative identification was performed by TLC and the content of icariin in guilu bushen pills was determined by HPLC. Result： Pericarpium Citri Reticulatae, Radix Astragali, Semen Ziziphi Spinosae and Herba Epimedii of this preparation were clearly identified. The linear range of icariin was 1 -30μg· ml^-1. The ave.rage recovery was 99. 87% with RSD of 2.5 %. Conclusion： This method is accurate and reproducible. It can be used as the quality control of guilu bushen pills.

关 键 词：龟鹿补肾丸 薄层色谱法 高效液相色谱法 淫羊藿苷 

分 类 号：TQ460.72[医药卫生—药物分析学]