HPLC法测定复方小檗碱鞣酸蛋白胶囊中盐酸小檗碱的溶出度  

Dissolution determination of Berberine Hydrochloride in Compound Berberine Hydrochloride Tannalbin Capsules by HPLC

作　　者：黄春青[1] 曹桂红[1] 祝晶[1] 杨婷 许波[1] HUANG Chunqing;CAO Guihong;ZHU Jing;YANG Ting;XU Bo(Guizhou Institute for Food and Drug Control,Guiyang 550004,China;Guiyang Food and Drug Inspection and Testing Center,Guiyang 550004,China)

机构地区：[1]贵州省食品药品检验所,贵州贵阳550004 [2]贵阳市食品药品检验检测中心,贵州贵阳550004

出　　处：《中国民族民间医药》2019年第19期23-26,共4页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：国家药品标准提高研究课题(107)

摘　　要：目的:建立测定复方小檗碱鞣酸蛋白胶囊中盐酸小檗碱溶出度的方法。方法:采用高效液相色谱法,用十八烷基硅烷键合硅胶为填充剂;以磷酸盐缓冲液[0.05 mol·L^-1磷酸二氢钾溶液和0.05 mol·L^-1庚烷磺酸钠溶液(1∶1),含0.2%三乙胺,并用磷酸调节pH值至3.0]-甲醇(43∶57)为流动相;检测波长为262 nm,进样量为10μL。以醋酸盐缓冲液(pH4.0)1000 mL为溶出介质,转速为150 r·min^-1,取样时间为45 min,温度为37℃。结果:盐酸小檗碱在30.312 5~303.124 9μg·mL^-1范围内呈良好的线性关系(r=1),回收率为99.36%(n=9,RSD=0.98%)。结论:本法操作简便,准确、可靠,可用于复方小檗碱鞣酸蛋白胶囊中盐酸小檗碱溶出度的测定。Objective To develop the method for the dissolution determination of berberine hydrochloride in Compound Berberine Hydrochloride Tannalbin Capsules. Methods HPLC method was used. Using octadecyl silane bonded silica as filler of chromatographic column, The mobile phase was made up of phosphate buffer [0.05 mol·L-1 potassium phosphate monobasic solution and 0.05 mol·L-1 sodium heptane-1-sulphonate solution(1∶1), containing 0.2% triethylamine and adjusting pH value to 3.0 with phosphoric acid]-methanol(43∶57),the detection wavelength was 262 nm,and the volume of injection was 10 μL·1000 mL of Acetate buffer(pH 4.0) was used as solvent. The rotation speed was 150 r·min-1,the sampling time was 45 min and the temperature was 37 ℃.Results Good linearity was shown for Berberine Hydrochloride in the concentration range of 30.312 5~303.124 9 μg·mL-1(r=1), The average recovery rate was 99.36%(n=9,RSD=0.98%).Conclusion The method is simple, accurate and reliable, and can be used to determination of the dissolution of berberine hydrochloride in Compound Berberine Hydrochloride Tannalbin Capsules.

关 键 词：复方小檗碱鞣酸蛋白胶囊 高效液相色谱法 盐酸小檗碱 溶出度 

分 类 号：R284.1[医药卫生—中药学]