摘要
目的研究阿立哌唑口腔崩解片(抗精神病药)的生物利用度。方法用随机自身交叉实验设计,24名男性健康受试者先后单剂量口服阿立哌唑口腔崩解片(试验制剂)及阿立哌唑片(参比制剂)20mg,用高效液相色谱-紫外检测法测定血浆中阿立哌唑浓度,用DAS1.0药代动力学程序处理血药浓度经时变化数据。结果单剂量口服试验制剂和参比制剂各20mg后的AUC0-t分别为(2520.6±2002.5),(2329.3±1771.0)μg·h·L-1;AUC0-∞分别为(2797.0±2096.7),(2742.9±1842.2)μg·h·L-1;Cmax分别为(62.3±37.8),(56.8±20.8)μg·L-1;tmax分别为(4.5±1.0),(4.4±0.9)h。2制剂比较均无显著性差异(P>0.05)。以阿立哌唑片为参比,口腔崩解片的相对生物利用度为(111.6±43.1)%。结论2种制剂具有生物等效性。
Objective To study the bioavailability of aripiprazole orally disintegrating tablets in healthy volunteers. Methods Twenty -four healthy male volunteers were enrolled in a randomized crossover study. The subjects orally administered a single dose of 20 mg aripiprazole orally disintegrating tablets （ test ） or 20 mg aripiprazole tablets （ reference ）. The concentrations of aripiprazole in plasma were assessed with HPLC - UV method and data were analyzed automatically with DAS 1.0 Pharmacokinetic program. The relative bioavailability of aripiprazole orally disintegrating tablets was calculated. Results The parameters of aripiprazole test and reference preparations were as following ： AUC0-1 t were （2520.6 ±2002.5） , （2329.3 ±1771.0） μg· h· L^-1（P〉0.05）; AUC0-∞ were （2797.0 ± 2096.7 ）, （2742.9 ± 1842.2） μg· h· L^-1 ; Cmax were （62.3±37.8）,（56.8±20.8） μg· L^-1（P〉0.05）; tmax were （4.5± 1.0）, （4.4 ± 0.9 ） h （ P 〉 0.05 ）. The relative bioavailability of aripiprazole orally disintegrating tablets was （ 111.6 ± 43.1 ） %. Conclusion Aripiprazole orally disintegrating tablets showed bioequivalence compared with aripiprazole tablets.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2006年第5期345-348,共4页
The Chinese Journal of Clinical Pharmacology
