【摘要】 目的研究氯诺昔康片(非甾体抗炎镇痛药)片在健康人体的药代动力学及相对生物利用度。方法用随机交叉给药方案,20名男性健康志愿者分别单剂量口服氯诺昔康受试片和参比片8mg,用HPLC-UV法检测血药浓度,计算药代动力学参数并评价其生物等效性。结果受试和参比制剂的主要药代动力学参数Cmax分别为(669.50±141.76)和(657.47±146.98)ng·mL-1;tmax分别为(1.85±0.75)和(1.85±0.88)h;t1/2(Kel)分别为(5.09±0.99)和(5.05±1.11)h;AUC0-24分别为(3276.50±650.33)和(3461.64±850.73)ng·h·mL-1;AUC0-∞分别为(3442.18±597.72)和(3612.05±857.13)ng·h·mL-1。受试制剂的相对生物利用度分别为F0-24=(97.49±21.16)%,以F0-∞=(98.10±19.75)%。结论国产与进口氯诺昔康片生物等效。更多还原

【Abstract】 Objective To study the pharmacokinetics and relative bioavailability of domestic and imported lornoxicam tablets. Methods A single dose of 8 mg lornoxicam tablet or its reference tablet was given to 20 healthy male volunteers in a randomized cross-over study. Plasma level of lornoxicam were detected by HPLC-UV method.Results The main pharmacokinetic parameters of lornoxicam were as follows: C_ max were (669.50±141.76 )and (657.47±146.98) ng·mL -1; t_ max were (1.85±0.75)and (1.85±0.88)h;t_ 1/2(Kel)were( 5.09±0.99)and( 5.05±1.11) h;AUC_ 0-24 were(3276.50±650.33)and (3461.64± 850.73) ng·h·mL -1;AUC_ 0-∞were(3442.18±597.72)and( 3612.05±857.13) ng·h·mL -1 for test and reference,respectively.The relative bioavalability were F_ 0-24=(97.49±21.16) % ,F_ 0-∞=(98.10± 19.75) %, respectively.Conclusion The result of statistical analysis showed that two formulations were bioequivalent.更多还原