湿热痹胶囊质量标准研究

Study on Quality Standard of Shirebi Capsules

目的:建立湿热痹胶囊的质量标准。方法:采用显微鉴别法鉴别处方中的薏苡仁,防己,连翘;采用薄层色谱法对处方防已,连翘,防风,关黄柏进行定性鉴别;采用高效液相色谱法测定盐酸小檗碱和盐酸巴马汀的含量。结果:显微特征明显;薄层色谱中可检出防己,连翘,防风,关黄柏,阴性均无干扰;盐酸小檗碱在5.2～105.1μg·L^(-1)范围内时,线性关系良好(r=0.999 9),盐酸巴马汀在5.2～104.4μg·L^(-1)范围内,线性关系良好(r=0.999 9);本方法平均回收率分别为97.4%,99.3%,RSD分别为1.2%,2.0%(n=6)。结论:该方法准确,重复性好,可用于湿热痹胶囊的质量控制。

Objective：To establish a method for the quality standard of Shirebi capsules.Method：Semen Coicis,Fourstamen Stephania Root and Fructus Forsythiae in the formula were identified by microscope testing.Fourstamen Slephania Root,Fructus Forsythiae, Raidix Saposhnikoviae and Cortex Phellodendri Amurene were identified by TLC.The contents of berberine hydrochloride and palmatine hydrochloride were determined by HPLC.Result：Microscopic characteristics were obvious.Fourstamen Slephania Root, Fructus Forsythiae,Raidix Saposhnikoviae and Cortex Phellodendri Amurene could be identified by TLC,and the other components showed no interference.Berberine hydrochloride showed a good linear relationship within the range of 5.2-105.1μg·L（-1）（r = 0.999 9）,and palmatine hydrochloride showed a good linear relationship within the range of 5.2-104.4μg·L（-1）（r = 0.999 9）.The average recovery was 97.4%and 99.3%with RSD of 1.2%and 2.0%（n = 6）,respectively.Conclusion：The method is accurate with good reproducibility,and suitable for the quality control of Shirebi capsules.