肾康口服液的质量标准研究  

Study on Quality Standard of Kidney Health oral Liquid

作　　者：刘腊娥[1] 陈立新[1] 刘凌云[1] 代君[1] 

机构地区：[1]中国人民解放军第163中心医院药剂科,湖南长沙410003

出　　处：《解放军药学学报》2004年第3期186-188,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的　制订肾康口服液质量标准。方法　采用薄层色谱法 (TLC)等 ,对该制剂中黄柏、墨旱莲及总生物碱等进行定性鉴别 ;高效液相色谱法 ,对制剂中君药黄柏的有效成分盐酸小檗碱进行定量分析 ,选用NovapakC18柱 (2 .5cm× 4 .6mm ,5 μm) ,加NovapakC18预柱 (2 .5cm× 4 .6mm) ;流动相 :甲醇 -乙腈 - 0 .0 5mol·L-1磷酸二氢钠 (2 0∶35∶4 5 ) ;柱温 2 4℃ ;检测波长 346nm ;流速1.0ml/min。结果　采用TLC法鉴别 ,专属性强 ,含量测定盐酸小檗碱的线性范围为 4 .0 0～ 2 0 .0 0 μg·ml-1(r =0 .9992 ) ,平均回收率为 10 1.32 % ,RSD =1.18% (n =5 )。结论　本文方法简便 ,准确 ,重现性好。Aim To establish quality standard of Kidney health oral liquid.Methods The Cortex Pheuodendri,Black lotus and total alkaloid were determined adopting TLC.The quantitative analysis of Berberine hydrochloride which is effective composition in Cortex Pheuodendri was made using HPLC.The mobile phase was consisted of methanol-aetonitrile-0.05mol·L -1 sodium dihydrogen phosphate(20∶35∶45).Temperature was 24℃,measuring wavelength was 346nm and velocity was 1.0ml/min.Results This method has speciality with TLC.Linear range of berberine hydrochloride is 4.0 to 20.0μg·ml -1(r=0.999 2) by HPLC.The average rate of recovery is 101.32%,RSD=1.18%(n=5).Conclusions The results suggest that this method is simple,convenient and accurate on determining the nature and quality,which can be used to control the quality of this product.

关 键 词：肾康口服液 质量标准 薄层色谱法 鉴别 盐酸小檗碱 

分 类 号：R286.0[医药卫生—中药学]