风寒感冒颗粒中含量测定方法研究  

Investigation on the test method of Fenghan Ganmao Granules

作　　者：黄晓婧 肖春霞 王欣 刘莉 李婷婷 文永盛 许莉 HUANG Xiaojing;XIAO Chunxia;WANG Xin;LIU Li;LI Tingting;WENG Yongsheng;XU Li(Chengdu Institute for Food and Drug Control/NMPA Key Laboratory for Quality Monitoring and Evaluation of Traditional Chinese Medicine(Chinese Materia Medica),Chengdu 610045,China)

机构地区：[1]成都市食品药品检验研究院/国家药品监督管理局中药材质量监测评价重点实验室,成都610045

出　　处：《中国药品标准》2021年第1期72-79,共8页Drug Standards of China

基　　金：2019年国家药品计划抽验项目(国药监药管〔2019〕2号,中央补助地方经费项目)。

摘　　要：目的:建立测定风寒感冒颗粒中盐酸麻黄碱、盐酸伪麻黄碱和葛根素含量的HPLC法,制定含量参考限度。方法:盐酸麻黄碱、盐酸伪麻黄碱含量以Sunfire C 18(4.6 mm×250 mm,5μm)为色谱柱,乙腈-0.02 mol·L^(-1)磷酸二氢钾溶液(含0.2%三乙胺,用磷酸调pH至2.7)(3∶97)为流动相,检测波长210 nm,柱温30℃;葛根素含量以Agilent ZORBAX Eclipse plus C 18(4.6 mm×250 mm,5μm)为色谱柱,甲醇-水(24∶76)为流动相;检测波长250 nm,柱温30℃。结果:三种成分进样量分别在0.0226~0.4514μg、0.0168~0.3359μg、0.1670~1.2524μg范围内线性关系良好(r为0.9999~1.0000);精密度、重复性、稳定性试验的RSD均小于2%;平均回收率分别为99.91%、99.79%、101.51%,RSD均小于3%。结论:新建立的方法专属性强,稳定性好,重复性好,可用于该制剂中盐酸麻黄碱、盐酸伪麻黄碱和葛根素的含量测定,测定了280批次样品的数据,拟定了含量参考限度值。Objective:To establish an HPLC method for the determination of ephedrine hydrochloride,pseudoephedrine hydrochloride and puerarin in Fenghan Ganmao Granules,and to set a reference limit for the contents.Methods:The contents of ephedrine hydrochloride and pseudoephedrine hydrochloride were determined by using Sunfire C 18 column(4.6 mm×250 mm,5μm)under the isocratic elution of acetonitrile-0.02 mol·L^(-1)potassium dihydrogen phosphate solution(containing 0.2%triethylamine,and adjusting the pH to 2.7 with phosphoric acid)(3∶97).The detection wavelength was 210nm,and the column temperature was 30℃.The content of puerarin was determined by using Agilent ZORBAX Eclipse plus C 18 column(4.6 mm×250 mm,5μm)under the isocratic elution of methanol-water(24∶76).The detection wavelength was 250 nm and the column temperature was 30℃.Results:The linear ranges of ephedrine hydrochloride,pseudoephedrine hydrochloride and puerarin fell into 0.0226-0.4514μg,0.0168-0.3359μg and 0.1670-1.2524μg,respectively(r as 0.9999-1.0000).The RSDs of the precision,repeatability and stability were less than 2%,and the average recoveries of ephedrine hydrochloride,pseudoephedrine hydrochloride and puerarin were 99.91%,99.79%,101.51%,respectively(RSD less than 3%).Conclusion:The established method has the strong specificity,good stability and good reproducibility.It can be used for the determination of ephedrine hydrochloride,pseudoephedrine hydrochloride and puerarin in Fenghan Ganmao Granules.280 batches of samples have been determined,and the content reference limits have been set.

关 键 词：风寒感冒颗粒 HPLC法 盐酸麻黄碱 盐酸伪麻黄碱 葛根素 

分 类 号：R921.2[医药卫生—药学]