前舒安胶囊的质量控制及原药中盐酸小檗碱的含量测定  

Quality Control of Qianshu'an Capsules and Content Determination of Berberine Hydrochloride in the Qianshu'an Capsules

作　　者：戴博 宋青 徐方楚 张兰欣 袁海龙 赵磊 DAI Bo;SONG Qing;XU Fangchu;ZHANG Lanxin;YUAN Hailong;ZHAO Lei(Air Force Characteristic Medical Center,Beijing 100142,China;Siping Institute for Food and Drug Control,Siping 136000,China;Changchun University of Traditional Chinese Medicine School of Medicine,Changchun 130117,China)

机构地区：[1]空军特色医学中心,北京100142 [2]四平食品药品检验所,吉林四平136000 [3]长春中医药大学,吉林长春130117

出　　处：《特产研究》2024年第6期120-124,131,共6页Special Wild Economic Animal and Plant Research

摘　　要：本研究开发了薄层色谱法对关黄柏及虎杖药材的鉴别方法,并建立了盐酸小檗碱含量的测定方法,为前舒安胶囊的质量控制提供依据。采用薄层色谱鉴别关黄柏及虎杖药材;高效液相色谱法测定关黄柏中盐酸小檗碱的含量,色谱柱为YMC-Pack Pro C18(4.6 mm×150mm,5μm),以乙腈:0.05 mol/L磷酸二氢钾(25:75)为流动相,柱温为40℃,检测波长为347 nm。结果表明,通过高效液相测定的盐酸小檗碱在9.2~147.6μg/mL的范围内,线性关系良好R=0.9995;平均回收率为100.42%,RSD为0.66%,关黄柏、虎杖的薄层色谱鉴别斑点清晰,专属性强。本研究建立的方法简便、准确、重现性和稳定性均良好,检测成本低,检测结果分析快速,可更有效地控制前舒安胶囊的质量。In this study,Phellodendron amurense and Polygonumcuspidatum were identified by TLC.To establish content determination of berberine hydrochloride in Qianshu'an capsules;it provides the basis for the quality control of Qianshu'an capsule.Determination of berberine hydrochloride content in Phellodendron amurense by HPLC on YMC-Pack Pro C18(4.6 mm×150 mm,5μm),acetonitrile-0.05 mol/L potassiumdihydrogen phosphate(25:75)asmobile phase;The column temperature is 40℃;The detection wavelength is 347 nm.The results showed that the linear range of berberine hydrochloride determined by HPLCranges from9.2 to 147.6 g/mL,the linear relationship is good,R=0.9995,the average recovery was 100.42%,RSD was 0.66%the TLC identification spots of Phellodendron amurense and Polygonum cuspidatum were clear and specific.The method for identification and content determination can be used for quality control of Qianshu'an capsule.

关 键 词：前舒安胶囊 薄层色谱法 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]