加味左金丸的质量标准研究

Study on the Quality Standard Of Jiaweizuojing Pills

目的:建立加味左金丸的质量控制标准。方法:采用薄层色谱法对制剂中黄连、吴茱萸、木香、香附、延胡索进行鉴别,用高效液相色谱法测定加味左金丸中盐酸小檗碱的含量。结果:在薄层色谱法中能够鉴别出黄连、吴茱萸、木香、香附、延胡索。盐酸小檗碱的进样量在0.204 08～0.816 32μg范围内成良好的线性,r=0.999 2,平均回收率为95.92%,RSD=0.85%(n=5)。结论:该方法操作简便,准确可靠,重现性好,可用于控制加味左金丸的质量。

Objective：To establish the quality standard for Jiaweizuojing Pill.Methods：Rhizma Coptids,Fructus Evodiae,Radix Aucklandiae,Rhizoma Cyperi,Rhizoma Corydalis in the pills were indentifyed by TLC.HCl Berberine content was determined by HPLC.Results：Rhizma Coptids,Fructus Evodiae,Radix Aucklandiae,Rhizoma Cyperi,Rhizoma Corydalis could be indentifyed by TLC.The linearity of HCl Berberine was fine in the range of 0.204 08～0.816 32 μg（r=0.999 2）.The average recovery was 95.92% and RSD was 0.85%（n=5）.Conclusion：The method is simple,feasible and repeatable,and can be used to control the quality of Jiaweizuojing Pills.