一测多评法同时测定麻黄配方颗粒中5种生物碱  

Simultaneous determination of five alkaloids in Mahuang Formula Granules by QAMS

作　　者：王玉梅 胡青 孙健 季申 WANG Yu-mei;HU Qing;SUN Jian;JI Shen(School of Pharmacy,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;National Medical Products Administration Key Laboratory for Quality Control of Traditional Chinese Medicine,Shanghai Municipal Institute for Food and Drug Control,Shanghai 201203,China)

机构地区：[1]上海中医药大学中药学院,上海201203 [2]上海市食品药品检验研究院,国家药品监督管理局中药质量控制重点实验室,上海201203

出　　处：《中成药》2023年第5期1438-1442,共5页Chinese Traditional Patent Medicine

基　　金：上海市人才发展资金项目(2019081);上海市科学技术委员会研发平台专项(21DZ2290200)。

摘　　要：目的建立一测多评法同时测定麻黄配方颗粒中盐酸去甲基麻黄碱、盐酸去甲基伪麻黄碱、盐酸麻黄碱、盐酸伪麻黄碱、盐酸甲基麻黄碱的含量。方法该药物70%甲醇提取液的分析采用Phenomenex Luna C_(18(2))色谱柱(250 mm×4.6 mm,5μm);流动相乙腈-0.2%磷酸,梯度洗脱;体积流量1.2 mL/min;柱温30℃;检测波长210 nm。以盐酸麻黄碱为内标,计算其他4种成分的相对校正因子,测定其含量。结果5种成分在各自范围内线性关系良好(r≥0.9998),平均加样回收率95.81%~100.52%,RSD 1.00%~2.49%。一测多评法所得结果与外标法接近。结论该方法快速简便,重复性好,可用于麻黄配方颗粒的质量控制。AIM To establish a quantitative analysis of multi-components by single maker(QAMS)method for the simultaneous content of phenylpropanolamine hydrochloride,dimethylpseudoephedrine hydrochloride,ephedrine hydrochloride,pseudoephedrine hydrochloride and methylephedrine hydrochloride in Mahuang Formula Granules.METHODS The analysis of 70%ethanol extract of this drug was performed on a 30℃thermostatic Phenomenex Luna C_(18(2))column(250 mm×4.6 mm,5μm),with the mobile phase comprising of acetonitrile-0.2%phosphoric acid flowing at 1.2 mL/min in a gradient elution manner,and the detection wavelength was set at 210 nm.Ephedrine hydrochloride was used as an internal standard to calculate the relative correction factors of the other four constituents,after which the content determination was made.RESULTS Five constituents showed good linear relationships within their own ranges(r≥0.9998),whose average recoveries were 95.81%-100.52%with the RSDs of 1.00%-2.49%.The result obtained by QAMS approximated those obtained by external standard method.CONCLUSION This rapid,simple and reproducible method can be used for the quality control of Mahuang Formula Granules.

关 键 词：麻黄配方颗粒 盐酸去甲基麻黄碱 盐酸去甲基伪麻黄碱 盐酸麻黄碱 盐酸伪麻黄碱 盐酸甲基麻黄碱 一测多评 

分 类 号：R927.2[医药卫生—药学]