参龙健脑胶囊质量标准的研究

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10～160 μg.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.

Study on quality standard of Shenlongjiannao capsules

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.