摘要
目的:进行A、B、C、D 4厂家米非司酮片健康女性受试者体内的药动学比较研究。方法:40名健康女性受试者随机分为4组,每组10人,分别服用4个不同厂家生产的米非司酮片75mg,于不同时间抽取肘静脉血,经液液萃取,采用高效液相色谱法测定米非司酮经时血浓度,DAS 2.0计算米非司酮药动学参数。结果:A、B、C、D 4厂家米非司酮片的Cmax分别为(1.57±0.36)μg.mL-1、(1.7±0.7)μg.mL-1、(1.4±0.4)μg.mL-1和(1.6±0.5)μg.mL-1;tmax分别为(0.70±0.26)h、(1.0±0.6)h、(1.0±0.6)h和(0.80±0.35)h;t1/2分别为(26.1±7.6)h、(26.7±5.2)h、(27.1±6.4)h和(28.9±7.4)h;AUC0-96分别为(20.3±5.1)μg.mL-1.h、(20.5±6.4)μg.mL-1.h、(18.1±8.7)μg.mL-1.h和(20.7±7.4)μg.mL-1.h。以A厂家米非司酮片为参比,B、C、D厂家米非司酮片相对生物利用度分别为101.1%、89.4%和101.8%。结论:所选择A、B、C、D 4厂家米非司酮片人体药动学过程差异无显著性。
OBJECTIVE To study the pharmacokinetics of four different preparations of mifepristone tablets in healthy female Chinese subjects.METHODS Forty subjects were randomly divided into four groups with ten in each group,given respectively a single oral dose of 75 mg of four different preparations of mifepristone tablets.A series of blood were collected in 96 h.And mifepristone was extracted using ethyl acetate and determined by high performance liquid chromatography.Pharmacokinetics parameters were calculated by Drug and Statistical Software Version 2.0.RESULTS The pharmacokinetics parameters after a single dose of 75 mg four preparations of mifepristone tablets were as follows：Cmax was（1.57±0.36） μg·mL-1,（1.7±0.7） μg·mL-1,（1.4±0.4） μg·mL-1 and（1.6±0.5） μg·mL-1;tmax was（0.70±0.26） h,（1.0±0.6） h,（1.0±0.6） h and（0.80±0.35） h;t1/2 was（26.1±7.6） h,（26.7±5.2） h,（27.1±6.4） h and（28.9±7.4） h;AUC0-96 was（20.3±5.1） μg·mL-1·h,（20.5±6.4） μg·mL-1·h,（18.1±8.7） μg·mL-1·h and（20.7±7.4） μg·mL-1·h respectively.The relative bioavailability of mifepristone tablet B,C,D to mifepristone tablet A was 101.1%、89.4%and 101.8%.CONCLUSION There was no significant difference among the pharmacokinetics of four different preparations of mifepristone tablets in healthy female Chinese subjects.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2012年第21期1716-1719,共4页
Chinese Journal of Hospital Pharmacy
