摘要
目的:比较2种氯雷他定片(LORAX和LORAS)在人体的相对生物利用度。方法:22名健康男性志愿者交叉单剂量(20mg)口服LORAX片或LORAS片,高效液相色谱法测定其血浆中氯雷他定浓度,3p97程序计算药动学参数。结果:LORAX片和LORAS片的t1/2Kc分别为(3.03±0.98)h、(2.65±0.81)h;Cmax为(8.59±6.70)、(9.59±8.22)ng/ml;tmax为(1.08±0.41)h、(1.21±0.28)h;AUC(0-t)为(27.29±24.54)、(27.92±20.64)(ng·h)/ml;LORAX的相对生物利用度为(100.63±14.27)%。结论:2种氯雷他定片具有生物等效性。
OBJECTIVE: To compare the relative bioavailability between 2 loratadine tablets (LORAX and LORAS) in human body. METHODS: 22 healthy male volunteers were enrolled to receive oral single dose (20mg) of either LORAX or LORAS tablets by crossover way, plasma concentrations of loratadine were determined by HPLC and pharmacokinetic parameters were calculated by 3p97 program. RESULTS: The pharmacokinetie parameters of LORAX vs. LORAS were the following,t1/2kc (3.03±0.98)h vs. (2.65±0.81)h; Cmax(8.59±6.70)vs. (9.59±8.22)ng/ml; tmax(1.08±0.41)h vs. (1.21±0.28) h; AUC(0~t) (27.29±24.54) vs. (27. 92±20.64) (ng·h)/ml.The relative bioavailability of LORAX was (100.63±14.27) %. CONCLUSION:2 loratadine tablets were bioequivalent.
出处
《中国药房》
CAS
CSCD
北大核心
2006年第7期518-519,共2页
China Pharmacy