节点文献
烯丙雌醇片在健康人体的药代动力学研究
Pharmacokinetic Study of Allylestrenol Tablets in Healthy Volunteers
【摘要】 目的:建立准确、灵敏的液相色谱—串联质谱法(LC-MS/MS)测定人血浆中烯丙雌醇的浓度,并评价中国健康女性受试者单剂量口服烯丙雌醇片后的药动学特征。方法:20例女性健康受试者单剂量口服20mg烯丙雌醇片后按时采集血样,以米非司酮为内标,采用APCI正离子选择性反应监测测定烯丙雌醇血浆浓度,计算药动学参数。结果:单剂量口服20mg烯丙雌醇后,烯丙雌醇的主要药动学参数Cmax为(12.48±4.18)ng·ml-1,Tmax为(1.9±0.8)h,t1/2为(8.4±3.2)h,MRT0-∞为(6.7±2.6)h,AUC0-36为(41.29±14.83)h·ng·ml-1,AUC0∞为(42.72±15.33)h·ng·ml-1。结论:建立的LC-MS/MS测定法结果准确可靠,灵敏度高。
【Abstract】 Objective:To establish an accurate and sensitive LC-MS/MS method for the determination of allylestrenol in plasma end to evaluate its pharmacokinetic study in healthy Chinese women volunteers after po the allylestrenol tablets.Methods:The 20 healthy women volunteers received allylestrenol tablet respectively for a single oral dose of allylestreno120mg.The plasma concentrations of allylestrenol were determined by a validated LC-APCI-MS/MS method with positive ion SRM mode using mifepristone as internal standard.The pharmacokinetic parameters were calculated.Results:The main pharmacokinetic parameters after the single oral dose of allylestrenol tablet(20mg)were as follows:Cmax was(12.48±4.18)ng·ml-1,Tmax was(1.9±0.8)h,t1/2 was(8.4±3.2)h,MRT0-oo was(6.7±2.6)h,AUC0-36 was(41.29±14.83)h·ng·ml-1 ,AUC0-∞was(42.72±15.33)h.ng.ml-1.Concluslons:The validated LC-MS/MS for the determination of allylestrenol in human plasma is accurate,sensitive and reliable.
【Key words】 Allylestrenol; Pharmacokinetics; LC-MS/MS; APCI(atmospheric pressure chemical ionization);
- 【文献出处】 中国医药导刊 ,Chinese Journal of Medicinal Guide , 编辑部邮箱 ,2009年11期
- 【分类号】R969.1