利巴韦林雾化吸入液的含量测定及体外肺沉积率考察  

Assay of Ribavirin Solution for Inhalation and in vitro Study of Its Lung Deposition Property

作　　者：袁其红 宋杨[2] 申宝德[2] 范娜[2] 徐平华[2] 王啸洋[2] 张诗龙[2] 张木子荷 韩晋[2] YUAN Qi-hong SONG Yang SHEN Bao-de FAN Na XU Ping-hua WANG Xiao-yang ZHANG Shi-long ZHANG Mu-zi-he HAN Jin(Jiangxi University of Traditional Chinese Medicine,Nanchang 330000, China Hospital 302 of PLA,Beijing 100039,China)

机构地区：[1]江西中医药大学,江西南昌330000 [2]解放军302医院,北京100039

出　　处：《解放军药学学报》2016年第6期521-523,共3页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：军队后勤科研重点项目;No.BWS14C050

摘　　要：目的建立HPLC法测定利巴韦林雾化吸入液中利巴韦林含量的方法,并对其体外沉积率进行考察。方法采用SB-AQ C18色谱柱(250mm×4.6mm,5μm),流动相为水,流速:1.0ml·min^(-1),检测波长:207nm。采用新一代多级药用撞击器测定利巴韦林雾化吸入液的有效部位沉积率。结果在41.6~416μg·ml^(-1)范围内,峰面积对质量浓度有良好的线性关系,日内精密度和日间精密度均<2%(n=5);回收率在98%~102%;体外沉积率为68.51%。结论本含量测定方法准确可靠、重复性好,该制剂的体外肺沉积率符合要求。Objective To establish an HPLC method for determination of ribavirin solution for inhalation,and investigate its deposition propertyin vitro.Methods A column packed with SB-AQ C18（250mm×4.6mm,5μm）was used.The mobile phase was water and the flow rate was 1ml·min^（-1）.The UV detection wavelength was set at 207 nm.The in vitro deposition property of the solution was assessed with the next generation pharmaceutical impactor.Results The calibration curve was linear in the range of 41.6to 416μg·ml^（-1）.The average recovery ranged from 98% to 102%.The repeatability and intermediate precision RSD was less than 2%.The in vitro deposition test showed that the lung deposition rate was 68.51%.Conclusion This method is reliable,reproducible and suitable for the determination of ribavirin solution for inhalation.The in vitrolung deposition rate meets the standard.

关 键 词：利巴韦林 雾化吸入液 含量测定 HPLC 体外沉积率 

分 类 号：R927.2[医药卫生—药学]