摘要
目的:研究米格列奈片的药代动力学。方法:20名健康志愿者分别单剂量口服5 mg和10 mg国产米格列奈片,用HPLC-MS/MS法测定血药浓度,计算药代动力学参数。结果:口服5 mg和10 mg米格列奈片后的主要药代动力学参数:Cmax分别为(570.20±76.37)和(899.75±133.67)ng·mL-1;tmax分别为(0.51±0.13)和(0.51±0.19)h;AUC0-6分别为(753.82±355.17)和(1848.68±441.93)ng·h·mL-1;AUC0-∞分别为(787.74±383.46)和(1957.65±507.04)ng·h·mL-1;t1/2分别为(1.91±0.13)和(1.35±0.26)h。结论:本方法适用于米格列奈片临床药代动力学的研究。
Objective： To study pharmacokinetics of mitiglinide tablets in health volunteers. Methods： A single dose 5 mg and 10 mg mitiglinide tablets was given to 20 healthy volunteers. The pharmacokinetics were measured. Results：The main pharmacokinetic of 5 mg and 10 mg test tablets were as follow： Cmax were （570. 20±76. 37） and （899.75±133.67）ng· mL^-1 ;tmax were （0. 51±0. 13） and （0. 51±0. 19） h;AUC0-6 were （753.82 ±355.17） and （ 1848.68 ± 441.93 ） ng·h· mL^- 1 ; AUCo-∞ were （787.74 ± 383.46 ） and （ 1957.65± 507.04 ）ng h ·mL^-1 ; t1/2 were （ 1.91±0. 13） and （ 1.35 ±0. 26） h. Conclusion：The methodology to determine plasma concen- tration and pharmacokinetic profiles of mitiglinide tablets by HPLC -MS/MS were reachieved.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2009年第2期225-228,共4页
Chinese Journal of Pharmaceutical Analysis
