Tan W C, Lee H S
Department of Medicine, National University of Singapore.
Eur J Clin Pharmacol. 1991;41(5):495-6. doi: 10.1007/BF00626378.
Using a double blind, double dummy crossover design, single dose and steady state pharmacokinetics of oral controlled release (SCR) salbutamol 4 mg and 8 mg tablets b.d. has been studied in 8 Asian patients. Plasma salbutamol was measured over 12 h. In 8 patients the single dose mean Cmax was 4.2 ng.ml-1 and 7.7 ng.ml-1 after 4 and 8 mg, respectively. In 5 patients the steady state mean Cmax, Cmin and tmax were 8.1 ng.ml-1 and 4.7 ng.ml-1 and 6 h for the 4 mg tablets and 14.1 ng.ml-1 and 7.1 ng.ml-1 and 4 h for the 8 mg tablets. It is concluded that both doses of SCR show features of controlled release and that they produced a relatively constant plasma level of salbutamol in Asian patients.
采用双盲、双模拟交叉设计,对8名亚洲患者研究了口服4毫克和8毫克缓释沙丁胺醇片每日两次的单剂量和稳态药代动力学。在12小时内测定血浆沙丁胺醇。8名患者中,4毫克和8毫克剂量后的单剂量平均Cmax分别为4.2纳克·毫升⁻¹和7.7纳克·毫升⁻¹。5名患者中,4毫克片剂的稳态平均Cmax、Cmin和tmax分别为8.1纳克·毫升⁻¹、4.7纳克·毫升⁻¹和6小时,8毫克片剂分别为14.1纳克·毫升⁻¹、7.1纳克·毫升⁻¹和4小时。结论是,两种剂量的缓释制剂均显示出控释特性,且在亚洲患者中产生了相对稳定的血浆沙丁胺醇水平。