中国临床药理学杂志Issue(8)：685-688,4.
盐酸美普他酚胶囊在中国健康受试者中的药代动力学研究
Pharmacokinetic study of meptazinol hydrochloride capsule in Chinese healthy volunteers
摘要
Abstract
Objective To study the pharmacokinetic characteristics of meptazinol after single oral dose and multiple doses of meptazinol hydro-chloride capsule in Chinese healthy volunteers.Methods A random-ized, open, 3 ×3 Latin square design was adopted.Twelve healthy vol-unteers were divided into six groups , two people ( one male and one fe-male) per group.The dosages are 100 mg, 200 mg and 400 mg in single dosage study , and 200 mg every 6 hours for 5 times in multiple dosage study.The concentrations of meptazinol in plasma were determined by HPLC -MS/MS.The pharmacokinetic parameters were calculated by WinNonlin 6.1 software.Results The main pharmacokinetics parame-ters of meptazinol in three single dose were as follow: Cmax were (22.21 ±12.74), (55.01 ±36.38) and (97.80 ±64.23) μg· L-1;tmax were (1.00 ±0.54),(1.04 ±0.61) and (1.54 ±0.91) h; t1/2 were (2.31 ±0.24), (2.31 ±0.24 ) and (2.46 ±0.59 ) h; AUCinf were ( 50.78 ±13.14 ) , ( 134.06 ±56.90 ) and ( 281.34 ±135.34 )μg· h· L-1.The main pharmacokinetic parameters of meptazinol under multiple dose were as follow:Cssmin was ( 6.01 ±2.03 ) μg · L-1 , Cmax was ( 54.30 ±27.10 ) μg · L-1 , Cavg was (20.13 ±6.82) μg· L-1, tmax was(1.06 ±0.51) h, t1/2 was (2.62 ±0.24) h, and AUCinf was (149.63 ±50.49)μg · h· L-1.Conclusion The plasma concentrations of meptazinolin in Chinese healthy volunteers were proceeded in an apparently mono-exponential fashion after a single oral dose from 100 mg to 400 mg meptazinol hydrochloride cap-sula.Meptazinol has no accumulation in the human body , after multiple doses of 200 mg every 6 hours for 5 times.The accumulation of meptazinol is consistent with linear pharmacokinetic process.关键词
盐酸美普他酚/药代动力学/高效液相色谱-串联质谱Key words
meptazinol hydrochloride/pharmacokinetic/HPLC-MS/MS分类
医药卫生引用本文复制引用
杨常成,郭歆,苏桃,刘智,冉黎灵,郭韧..盐酸美普他酚胶囊在中国健康受试者中的药代动力学研究[J].中国临床药理学杂志,2014,(8):685-688,4.基金项目
国家自然科学基金资助项目 （）
