复方小檗碱鞣酸蛋白胶囊的质量控制研究  

Quality evaluation of compound berberine hydrochloride tannalbin capsules

作　　者：黄春青[1] 祝晶 曹桂红[1] 杨婷 许波[1] 罗曼[1] HUANG Chun-qing;ZHU Ji ng;CAO Gui-hong;YANG Ting;XU Bo;LUO Man(Guizhou Institute for Food and Drug Control,Guizhou Guiyang 550004,China;Guiyang Food and Drug Inspection and Testing Center,Guizhou 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：《中国医院药学杂志》2019年第21期2152-2156,共5页Chinese Journal of Hospital Pharmacy

基　　金：国家药品标准提高研究课题(编号:107)

摘　　要：目的:建立测定复方小檗碱鞣酸蛋白胶囊中4种成分含量及马来酸氯苯那敏与硝酸硫胺含量均匀度的方法。方法:采用均匀实验优选复方小檗碱鞣酸蛋白胶囊中4种成分含量测定提取方法,采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,并用磷酸调节至pH 3.0]-甲醇(43∶57)为流动相;检测波长262 nm;进样量10μL,测定复方小檗碱鞣酸蛋白胶囊中盐酸小檗碱、马来酸氯苯那敏、硝酸硫胺和乳酸依沙吖啶含量及马来酸氯苯那敏与硝酸硫胺含量均匀度。结果:硝酸硫胺在25.02~200.2μg·mL^-1、马来酸氯苯那敏在6.555~78.66μg·mL^-1、盐酸小檗碱在12.01~96.06μg·mL^-1和乳酸依沙吖啶在2.491~24.91μg·mL^-1范围内呈良好的线性关系。回收率分别为104.19%、98.41%、100.48%和98.72%,RSD(n=9)分别为0.56%、1.16%、1.72%和1.67%。结论:建立了简便、快速、准确测定复方小檗碱鞣酸蛋白胶囊中4种成分含量及马来酸氯苯那敏与硝酸硫胺含量均匀度的方法,为复方小檗碱鞣酸蛋白胶囊质量标准的完善提高提供依据。OBJECTIVE To establish an HPLC mothod for the determination of four components and the content uniformity of chlorpheniramine maleate and thiamine nitrate in compound berberine tannin capsules. METHODS Homogeneity test was used to optimize the extraction method of four components in compound berberine tannin capsules, using octadecylsilane bonded silica gel as filler and phosphate buffer solution [0.05 mol·L^-1 potassium dihydrogen phosphate solution and 0.05 mol·L^-1 sodium heptanesulfonate solution(1∶1), containing 0.2% triethylamine, adjust pH to 3.0 with phosphoric acid]-methanol(43∶57) as mobile phase;detection wavelength 262 nm;injection volume 10 μL. The content of berberine hydrochloride, chlorpheniramine maleate, thiamine nitrate and ethacridine lactate and the content uniformity of chlorpheniramine maleate and thiamine nitrate in compound berberine tannate protein capsules were determined. RESULTS Good linearity was shown for thiamine nitrate in the concentration range of 25.02-200.2 μg·mL^-1(R=1), Good linearity was shown for chloropheniramine maleate in the concentration range of 6.555-78.66 μg·mL^-1(R=0.999 5), Good linearity was shown for berberine hydrochloride in the concentration range of 12.01-96.06 μg·mL^-1(R=0.999 5), Good linearity was shown for ethacridine lactate in the concentration range of 2.491-24.91 μg·mL^-1(R=0.999 5), The average recovery rates were 104.19%, 98.41%, 100.48% and 98.72%, and RSD(n=9) were 0.56%, 1.16%, 1.72% and 1.67%, respectively. CONCLUSION A simple,accurate and efficient HPLC method for the determination of four components in compound berberine hydrochloride tannalbin capsules and the content uniformity of chlorphenamine maleate and thiamine nitrate has been established, which provides a basis for the improvement of the quality standard of 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 含量 含量均匀度 

分 类 号：R927.2[医药卫生—药学]