益肾胶囊质量标准研究

Quality standard for Yishen Capsules

目的:建立益肾胶囊质量标准。方法:采用薄层色谱法对方中淫羊藿、白芍、人参、黄芪、甘草进行定性鉴别;采用高效液相色谱法对淫羊藿苷进行含量测定。结果:薄层鉴别均斑点清晰,阴性对照无干扰;含量测定中淫羊藿苷在0.254～0.762μg范围内,进样量与峰面积线性关系良好,相关系数r=0.9994,平均回收率为99.12%,RSD=1.54%(n=6)。结论:所建立方法操作简单、专属性和重现性良好,可作为该制剂的质量控制方法。

AIM：To establish the quality standard of Yishen Capsules; METHODS：Herba Epimedii,Radix Paeoniae Alba ,Radix Et Rhizoma Ginseng,Radix Astragali,Radix Et Rhizoma Glycyrrhizae,Pericarpium Citri Reticulatae Viride were identified by TLC.The content of Icraiin was determined by HPLC.RESULTS：The TLC sports developed were fairly clear,and the blank test showed no interference.The control content of Icraiin was within the range of 0.254μg-0.762μg,and there was the fine linearship between the sample input and the peak area,the average recovery was 99.12%, RSD was 1.54% （n =6）.CONCLUTION： The method is simple, reliable, accurate and can be applied as the quantity control method of Yishen Capsules.