参龙健脑胶囊质量标准的研究  

Study on quality standard of Shenlongjiannao capsules

作　　者：白林[1] 王超[2] 

机构地区：[1]解放军总医院药品保障中心药检室,北京100853 [2]大理学院药学院,云南大理671000

出　　处：《中国药物应用与监测》2012年第1期22-25,共4页Chinese Journal of Drug Application and Monitoring

基　　金：解放军总医院新药研发基金课题

摘　　要：目的:建立参龙健脑胶囊质量控制方法。方法:采用TLC方法对参龙健脑胶囊中的人参、地龙、淫羊藿药材进行定性鉴别;采用HPLC法对参龙健脑胶囊中的淫羊藿苷进行含量测定。色谱条件:Zorbax Eclipse XDB-C18柱(250 mm×4.6mm,5μm),以乙腈-水-磷酸(30∶70∶0.025)为流动相,柱温40℃,流速1 mL.min-1,检测波长270 nm。结果:采用TLC法能检出人参、地龙、淫羊藿;淫羊藿苷在10～160μg.mL-1浓度范围内与峰面积呈良好的线性关系(r=1.000,n=5)。淫羊藿苷的平均回收率为99.5%,RSD=0.96%。结论:本方法可准确地进行定性、定量,可用于控制参龙健脑胶囊的质量。Objective： To establish the quality control method of Shenlongjiannao capsules.Methods： Radix Et Rhizoma Ginseng,Pheretima,and Herba Epimedii of Shenlongjiannao capsules were identified by the method of TLC.The content of icariin in Shenlongjiannao capsules was measured by HPLC,Zorbax Eclipse XDB-C18column（250 mm×4.6 mm,5 μm） was used and the mobile phase was a mixture of acetonitrile-water-phosphoric acid（30∶70∶0.025）,with column temperature at 40 ℃.The flow rate was 1 mL.min-1 and the detection wavelength was 270 nm.Results： Radix Et Rhizoma Ginseng,Pheretima,and Herba Epimedii could be detected by TLC;the linear curve of icariin was shown in the range of 10 – 160 μg.mL-1（r = 1.000,n = 5）.The average recovery of icariin was 99.5%,RSD = 0.96%.Conclusion： This method is simple,reliable,accurate,and could be used in the standard quality control of Shenlongjiannao capsules.

关 键 词：参龙健脑胶囊 质量控制 淫羊藿苷 含量测定 高效液相色谱法 

分 类 号：R286[医药卫生—中药学]