高效液相色谱法测定清热解毒颗粒中盐酸小檗碱的含量  

The Content of Berberine Hydrochloride in Qingre Jiedu Granule was Determined by HPLC

作　　者：万勇 杨毅生 付志文 周志强 洪挺 WAN Yong;YANG Yisheng;FU Zhiwen;ZHOU Zhiqiang;HONG Ting(Jiangxi Provincial Inspector Center for Drug,Nanchang Jiangxi 330029,China;Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China;Jiangxi Conba Traditional Chinese Medicine Co.,Ltd.,Shangrao Jiangxi 334400,China.)

机构地区：[1]江西省药品检查员中心,江西南昌330029 [2]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029 [3]江西康恩贝中药股份有限公司,江西上饶334400

出　　处：《药品评价》2021年第5期269-272,共4页Drug Evaluation

基　　金：江西省食品药品监督管理局科研项目(2017YX04)。

摘　　要：目的:建立高效液相色谱(HPLC)法测定清热解毒颗粒中盐酸小檗碱的含量。方法:采用SunFire-C18色谱柱(4.6×250 mm,5μm),以乙腈-0.05mol/L磷酸二氢钾(22∶78)为流动相;流速为1.0 mL/min;柱温30℃;检测波长346 nm。结果:盐酸小檗碱进样量在0.003958~0.4948μg(r=0.9999)之间呈良好的线性关系,平均回收率为97.7%,RSD为1.6%(n=6)。结论:建立的方法灵敏度高,重复性好,专属性强,可为清热解毒颗粒质量标准控制提供参考。Objective:HPLC method was establish for determination of Berberine Hydrochloride in Qingre Jiedu granules.Methods:SunFire-C18 column(4.6 mm×250 mm,5μm)was used,the mobile phase comprising of acetonitrile-0.05 mol/L monopotassium phosphate(22∶78),the column temperature was 30℃,the velcoity was 1.0 mL/min and the detection wavelength was 346 nm.Results:The linear range of Berberine Hydrochloride was 0.003958~0.4948μg(r=0.9999),the average recovery was 97.7%,RSD=1.6%(n=6).Conclusion:The established method has high sensitivity,good repeatability and specificity,can provide reference for the quality control of Qingrejiedu granules.

关 键 词：清热解毒颗粒 高效液相色谱法 盐酸小檗碱 含量测定 

分 类 号：R286.0[医药卫生—中药学]