摘要
目的研究米格列醇在人体内的药动学特点和国产米格列醇片的生物等效性。方法18名健康男性受试者,采用双周期交叉、自身对照试验设计,单剂量口服100mg米格列醇,按照设定时间采集血样,预处理后的标本经LCMS法进行检测。结果经3P87拟合出米格列醇在人体内的主要药动学参数Ke为(0.36±0.06)h-1,Ka为(0.74±0.24)h-1,T1/2(a)为(1.03±0.33)h-1,T1/2(b)为(2.5±0.9)h,Tpeak为(2.4±0.6)h,Cmax为(1883.9±912.4)μg·L-1,AUC为(7592.7±4207.4)μg·h·L-1,CL/f为(0.020±0.020)L·h-1,V/f为(0.06±0.07)L。方差分析结果表明,国产米格列醇片与法国产米格列醇片的主要药动学参数之间差异不明显。国产米格列醇的相对生物利用度为(97.1±13.5)%。结论米格列醇在人体内的药动学特点符合一室模型,国产米格列醇与法国SanofiSynthelabo公司生产的米格列醇是生物等效的。
OBJECTIVE To investigate the pharmacokinetic properties and bioequiavailability of miglitol in Chinese subjects. METHODS Designed by crossing over with double cycle and own control, volunteers took single 100 mg miglitol at every experimental morning, then collecting the blood samples according to the study. After finished the pretreatment, the samples were determined by LC-MS. RESULTS The pharmacokinetic parameters, such as Ke .Ka. T1/2（a）, T1/2（b）. Tpeak .Cmax .AUC.CL/f.V/f of miglitol in Chinese are（0. 36±0. 06）h^-1,（0. 74±0. 24）h^-1,（1.03±0. 33）h,（2.5 ±0.9）h,（2.4±0.6） h,（1 883.9±912.4） μg·L^-1, （7 592. 7 ± 4207. 4） μg·h·L^-1, （0. 020± 0. 020 ） L·h^-1, （0. 06 ± 0. 07 ） L, respectively. The major pharmacokinetic parameters between test and reference miglitol were not significant different. CONCLUSION The major pharmacokinetic properties of miglitol in Chinese are fit to one compartment model. The mlglitol made in chengdu sankang pharmaceutical company is bioequiavailability to the Sanofi Synthelabo France＇s.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2005年第5期409-411,共3页
Chinese Journal of Hospital Pharmacy
关键词
米格列醇
药动学
生物等效性
miglitol
pharmacokinetics
bioequiavailability
