RP-HPLC法测定不同厂家黄连上清片中小檗碱含量  

Determination of Berberine in Huanglianshangqing Tablets from Different Manufacturers by RP-HPLC

作　　者：陈家艺 田力 时嘉琪 刘莉 涂星 Chen Jiayi;Tian Li;Shi Jiaqi;Liu Li;Tu Xing(Minda Hospital of Hubei University for Nationalities,Enshi 445000,China;Hubei University for Nationalities,Enshi 445000,China;Hubei Provincial Key Lab of Occurrence and Intervention of Rhumatic Disease,Enshi 445000,China)

机构地区：[1]湖北民族大学附属民大医院,湖北恩施445000 [2]湖北民族大学医学部,湖北恩施445000 [3]风湿性疾病发生与干预湖北省重点实验室,湖北恩施445000

出　　处：《湖北民族学院学报（医学版）》2019年第4期21-23,28,共4页Journal of Hubei Minzu University(Medical Edition)

基　　金：湖北省大学生创新创业项目(S201910517032);湖北省教育科学规划重点课题(2016GA024)

摘　　要：目的测定不同厂家黄连上清片中盐酸小檗碱的含量,判断是否符合药典要求。方法采用RP-HPLC,选用十八烷基硅烷键合硅胶为填充剂柱,以乙腈-0.3%磷酸(24∶76)为流动相,流速为1 mL/min,柱温30℃,检测波长229 nm,进样量10μL。结果RP-HPLC法测定盐酸小檗碱在20~100μg/mL范围内呈现良好的线性关系,方程为y=2632.0345x+2318.1036,r=0.9907,平均回收率为98.38%(n=9),RSD为1.14%,重复性RSD为0.7%,精密度RSD为0.3%,稳定性RSD为0.8%。测得上海海虹实业金辰药业有限责任公司的黄连上清片含量为0.2768 mg,云南白药集团股份有限公司的黄连上清片含量为0.3267 mg,华阳(恩施)药业有限公司的黄连上清片含量为0.4606 mg,吉林省密之康药业有限责任公司的黄连上清片含量为0.4346mg,陕西盘龙药业股份有限公司制药厂的黄连上清片含量为0.3340 mg,湖北香连药业有限责任公司的黄连上清片含量为0.4846 mg,贵州百灵企业集团制药股份有限公司的黄连上清片含量为0.4427 mg,河南金鸿堂制药有限公司的黄连上清片含量为0.3036 mg。结论测定得8种不同厂家的黄连上清片中每片含黄连、黄柏以盐酸小檗碱(C20CH17NO 4 HCl)计,均达到了药典标准。Objective To explore the content of berberine hydrochloride in Huanglianshang-qing tablets from different manufacturers to determine whether it meets the requirements of the pharmacopoeia.Methods The reversed-phase high performance liquid chromatography,octadecylsilane bonded silica was used as the filler column,and the mobile phase was acetonitrile-0.3%phosphoric acid(24∶76).The flow rate was 1 mL/min,and the column temperature was 30℃.The detected wavelength was 229 nm.The injection volume was 10μL.Results Determination of berberine hydrochloride in a range of 20~100μg/mL by RP-HPLC and the equation was y=2632.0345 x+2318.1036,r=0.9907.The average recovery was 98.38%(n=9),RSD was 1.14%,RSD of repeatability was 0.7%,RSD of precision was 0.3%,RSD of stability was 0.8%.The content of berberine hydrochloride determined by this method reached the relevant standards,which were 0.2768,0.3267,0.4606,0.4346,0.334,0.4846,0.4427 mg and 0.3036 mg,respectively.Conclusion The berberine hydrochloride in Huanglianshangqing tablet were 0.2768,0.3267,0.4606,0.4346,0.334,0.4846,0.4427,0.3036 mg produced in Shanghai Haihong Industry Jinchen Pharmaceutical Co.,Ltd.,Yunnan Baiyao Group Co.,Ltd.,Huayang(Enshi)Pharmaceutical Co.,Ltd.,Jilin Province Mizhikang Pharmaceutical Co.,Ltd.,Shaanxi Panlong Pharmaceutical Co.,Ltd.,Hubei Xianglian Pharmaceutical Co.,Ltd.,Guizhou Bailing Enterprise Group Pharmaceutical Co.,Ltd.and Henan Jinhongtang Pharmaceutical Co.,Ltd.,respectively.The content of berberine hydrochloride(C 20 CH 17 NO 4 HCL)containing berberine and Phellodendron chinense in eight different manufacturers was determined to meet the pharmacopoeia standards.

关 键 词：反相高效液相法 黄连上清片 盐酸小檗碱 含量测定 

分 类 号：R286[医药卫生—中药学]