CAJ | 학술논문

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牛物等效性.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周期交叉门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巾氨磺必利浓度.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:AUC_(0-48)分别为(3.01±0.86),(2.94±0.88)μg·h·mL~(-1),C_(max)分别为(392.19±135.35),(419.84±154.25)ng·mL~(-1),t_(1/2)分别为(9.42±3.02),(8.89±3.05)h,t_(max)分别为(3.70±0.80),(3.80 4±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.
목적 평개국산화진구안광필리편(항정신병약)재중국건강인체적약대동역학급우물등효성.방법 20명건강수시자안체질량배대후,수궤분위2조,단제2주기교차문복안광필리시험제제화삼비제제200 mg,취주정맥혈4mL,용고효액상색보-천련질보법측정혈장건안광필리농도.용DAS 2.0연건계산약대동역학삼수화상대생물이용도,평개기생물등효성.결과 안광필리편시험제제화삼비제제주요약대동역학삼수:AUC_(0-48)분별위(3.01±0.86),(2.94±0.88)μg·h·mL~(-1),C_(max)분별위(392.19±135.35),(419.84±154.25)ng·mL~(-1),t_(1/2)분별위(9.42±3.02),(8.89±3.05)h,t_(max)분별위(3.70±0.80),(3.80 4±0.77)h,시험제제안광필리편상대생물이용도F위(104.00±17.10)%.결론 국산여진구안광필리편구유생물등효성.
Objective To evaluate the bioequivalence of domestic amisulpride hablets 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 col-lected at scheduled time.The concentrations of amisulpride were deter-mined bv HPLC-MS/MS method.Resuits The main pharmacokinetic parameters of two preparations were as follows:AUC_(0-48) were(3.01±0.86),(2.94±0.88)μg·h·mL~(-1),C_(max) were(392.19±135.35),(419.84±154.25)ng·mL~(-1),t_(1/2) were(9.42±3.02),(8.89±3.05)h,t_(max) were(3.70±0.80),(3.80±0.77)h,respectively.The relative bioavailability of domestic and imported amisulpride tablet to im-ported tablet was(104.0±17.1)%.Conclution The results demon-strated that the two preparations were bioequivalent.