一测多评法同时测定开喉剑喷雾剂(儿童型)中4种成分  

Simultaneous determination of four constituents in Kaihoujian Throat Spray (for Children) by QAMS

作　　者：张金鹤 石慧 周英 张丽艳 张海 董秀 刘雄伟 俸婷婷 ZHANG Jin-he;SHI Hui;ZHOU Ying;ZHANG Li-yan;ZHANG Hai;DONG Xiu;LIU Xiong-wei;FENG Ting-ting(College of Pharmacy,Guizhou University of Traditional Chinese Medicine,Guiyang 550025,China;Research Center for Application and Development of Medicine and Food Dual-use Resources in Guizhou University of Traditional Chinese Medicine,Guiyang 550025,China;Guizhou Sanli Pharmaceutical Co.,Ltd,Anshun 561100,China)

机构地区：[1]贵州中医药大学药学院,贵阳贵州550025 [2]贵州中医药大学药食两用资源应用与开发研究中心,贵阳贵州550025 [3]贵州三力制药股份有限公司,安顺贵州561100

出　　处：《中成药》2022年第6期1760-1765,共6页Chinese Traditional Patent Medicine

基　　金：国家重点研发计划项目(2018YFC1708100);贵州省科技计划项目(黔科合平台人才[2019]5407);贵州省“千”层次创新型人才(贵大“千”层次[2017]09);贵州中医药大学2021年度科研创新和探索专项(2018YFC170810202,2018YFC170810205);贵州中医药大学博士启动基金(贵中医博士启动[2019]16,贵中医博士启动[2019]11)。

摘　　要：目的 建立一测多评法同时测定开喉剑喷雾剂(儿童型)(八爪金龙、山豆根、蝉蜕等)中4种成分的含量。方法 该药物的分析采用Platisil-ODS色谱柱(250 mm×4.6 mm,5μm);流动相甲醇-0.1%磷酸(三乙胺调节pH至5.0);体积流量0.8 mL/min;柱温35℃;检测波长220、275、300 nm。以岩白菜素为内标,计算其他3种成分的相对校正因子,测定其含量。结果 苦参碱、岩白菜素、三叶豆紫檀苷、马卡因分别在56.73~496.37、64.19~561.68、8.29~72.52、1.96~17.19μg/mL范围内线性关系良好(r≥0.999 6),平均加样回收率分别为99.89%、96.77%、92.12%、97.29%,RSD分别为1.57%、1.98%、0.96%、1.36%。一测多评法所得结果与外标法接近。结论 该方法简便可行,准确可靠,可用于开喉剑喷雾剂(儿童型)的质量控制。AIM To establish a quantitative analysis of multi-components by single-marker(QAMS) method for the simultaneous content determination of four constituents in Kaihoujian Throat Spray(for Children) [Ardisia crispa(Thunb.) A.DC.,Sophorae tonkinensis Radix et Rhizoma,Cicadae Periostracum,etc.METHODS The analysis of this drug was performed on a 35 ℃ thermostatic Platisil-ODS column(250 mm×4.6 mm,5 μm),with the mobile phase comprising of methanol-0.1%phosphoric acid(the pH was adjusted to 5.0 with triethylamine) flowing at 0.8 mL/min in a gradient elution manner,and the detection wavelengths were set at 220,275,300 nm.Bergenin was used as an internal standard to calculate the relative correction factors of the other three constituents,after which the content determination was made.RESULTS Matrine,bergenin,trifolirhizin,maackiain showed good linear relationships within the ranges of 56.73-496.37,64.19-561.68,8.29-72.52,1.96-17.19 μg/mL(r≥0.999 6),whose average recoveries were 99.89%,96.77%,92.12%,97.29%with the RSDs of 1.57%,1.98%,0.96%,1.36%,respectively.The result obtained by QAMS approximated those obtained by external standard method.CONCLUSION This simple,feasible,accurate and stable method can be used for the quality control of Kaihoujian Throat Spray(for Children).

关 键 词：开喉剑喷雾剂(儿童型) 苦参碱 岩白菜素 三叶豆紫檀苷 马卡因 一测多评 

分 类 号：R927.2[医药卫生—药学]