摘要
建立了DUSA管(单位剂量取样装置)法分析并测定利巴韦林气雾剂的每揿主药含量。利巴韦林气雾剂经适配器连接上DUSA管,通过真空泵控制空气流速为(28.3±1.5)L/min,采用高效液相色谱法测定3批样品的每揿主药含量,结果分别为(0.459 5 0.073 8)、(0.447 8 0.052 8)和(0.447 6 0.050 4)mg。并与法定标准测定结果比较,DUSA管法测得结果低约20%,更能反映出真正进入人体内的药物剂量。
A dosage unit sampling apparatus (DUSA) method was established for the determination of the content per actuation in ribavirin aerosol. The aerosol was connected with DUSA through an adaptor, and the flow rate was controlled at (28.3± 1.5) L/min by a vacuum pump. An HPLC method was utilized for the determination of ribavirin. The contents per actuation of 3 batches of samples were determined. The results were (0.459 5±0.073 8), (0.447 8±0.052 8) and (0.447 6±0.050 4) mg, respectively, which was approximately 20% less than the contents determined by the current official method. However, the results by DUSA method represented the actual dose administrated to patients.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2013年第10期1021-1024,共4页
Chinese Journal of Pharmaceuticals
基金
国家药典会气雾剂专项课题(2011-668)