摘要
目的:研究2种头孢克洛颗粒剂在10名健康志愿者体内的生物利用度.方法:同体交叉试验后,用RP-HPLC法测定血浆中头孢克洛浓度,药-时数据用3P87程序拟合,按一室模型计算药物动力学参数.结果:试验品和对照品单剂量po后,t_(max)分别为(24.17±3.72)和(24.40±4.19)min,c_(max)为(8.99±1.38)和(9.13±1.80)μg/ml,AUC_(0→∞)为(539.98±72.30)和(560.48±49.36)min·μg/ml.试验品的相对生物利用度为96.50%.结论:2种颗粒剂生物等效.
AIM: To study phamacokinetics and bioavailability of cefaclor granules in 10 healthy volunteers. METHODS:According to the crossover design,each volunteer was orally given cefaclor granules,and the plasma concentrations were determined by RP-HPLC. Phar-macokinetic parameters were obtained using 3P87 program,and were calculated on the basis of open single compartment model. RESULTS : After a single oral dose the peak levels in plasma averaged c_(max)(8. 99±1. 38) and (9.13±1. 80)μg/ml at (24.17±3. 72)and (24. 40± 4.19)min and AUC0-/were (539. 98±72. 30)and(560. 48±49. 36)min · μg/ml for developed and controlled formulations, respectively. The relative bioavailability of developed formulation was 96.50%. CONCLUSION : The result shows that two formulations are bioequiva-lence.
出处
《中国临床药学杂志》
CAS
1998年第5期208-211,共4页
Chinese Journal of Clinical Pharmacy
关键词
头孢克洛
颗粒剂
生物利用度
高效液相色谱
cefaclor
granules
bioavailability
reversedphase-high performance liquid chromatography
