国产与进口氨磺必利片在健康人体的药代动力学和生物等效性  

Pharmacokinetics and bioequivalence of domestic and imported amisulpride tablets in healthy volunteers

作　　者：李娴[1] 袁桂艳[1] 王本杰[1] 郭瑞臣[1] 

机构地区：[1]山东大学齐鲁医院临床药理研究所,济南250012

出　　处：《中国临床药理学杂志》2010年第1期33-36,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价国产和进口氨磺必利片(抗精神病药)在中国健康人体的药代动力学及生物等效性。方法20名健康受试者按体质量配对后,随机分为2组,单剂2周期交叉口服氨磺必利试验制剂和参比制剂200 mg,取肘静脉血4mL,用高效液相色谱-串联质谱法测定血浆中氨磺必利浓度。用DAS 2.0软件计算药代动力学参数和相对生物利用度,评价其生物等效性。结果氨磺必利片试验制剂和参比制剂主要药代动力学参数:AUC0-48分别为(3.01±0.86),(2.94±0.88)μg.h.mL-1,Cmax分别为(392.19±135.35),(419.84±154.25)ng.mL-1,t1/2分别为(9.42±3.02),(8.89±3.05)h,tmax分别为(3.70±0.80),(3.80±0.77)h,试验制剂氨磺必利片相对生物利用度F为(104.00±17.10)%。结论国产与进口氨磺必利片具有生物等效性。Objective To evaluate the bioequivalence of domestic amisulpride tablets and imported tablets. Methods A single oral dose of 200 mg domestic and imported amisulpride tablets were given to twenty healthy volunteers in a randomized crossover study. 4 mL blood was collected at scheduled time. The concentrations of amisulpride were determined by HPLC -MS/MS method. Results The main pharmacokinetic parameters of two preparations were as follows： AUC0-48 were （3.01 ± 0.86） ,（2.94±0. 88） μg · h · mL^-1, Cmax were （392. 19± 135.35）, （419.84± 154.25） ng · mL^-1, t1/2 were （9.42±3.02）,（8.89 ± 3.05） h, tmax were （3.70 ± 0. 80）, （3.80 ± 0. 77） h, respectively. The relative bioavailability of domestic and imported amisulpride tablet to imported tablet was （ 104.0 ±17.1 ） %. Conclution The results demonstrated that the two preparations were bioequivalent.

关 键 词：氨磺必利 生物等效性 药代动力学 高效液相色谱-串联质谱 

分 类 号：R969.1[医药卫生—药理学] R971.4[医药卫生—药学]