摘要
20名健康志愿者随机交叉给药先后一次口服格列吡嗪(受试和参比)片剂进行人体相对生物利用度研究。方法:采用HPLC—UV法和内标法定时检测其血药浓度,进行药代动力学分析。结果:经CAPP软件拟合所得的药时曲线均符合一室开放模型。格列吡嗪受试片与参比片的主要药动学参数分别为:T1/2k(h):2.68±0.46和2.71± 0.46; Cmax(μg·L-1): 622.53 ± 136.96和620.95 ± 117.36; Tmax(h): 1.93±0.18和1.95±0.15;MRT(h):5.94±0.37和5.96±0.45; AUC0-16(μg·h·L-1):2848.24±553.24和2962.38±530.13;这些参数经方差分析证明无显著性差异(P<0.05)。受试片剂对参比片剂的相对生物利用度(F%)为: 97.11±11.06。结论:两者的lnAUC、lnCmax、lnTmax经交叉试验下的方差分析法证明无显著性差异,经双单侧检验证明两种片剂具有生物等效性。
OBJECTIVE:A single dose of 10 mg glipizide test tablet or its reference tablet was given to 20 healthy male volunteers in a randomized cross-over study. METHODS: The pharmacokinetics and bioavailability of test glipizide tablets were compared with reference glipizide tablets. Plasma levels of glipizide were detected by HPLC-UV method. RESULTS: It was found that the plasma concentration-time curves of the two preparations were fitted to a one compartment model. The parameters of the two formulations for glipizide: Cmax(μg@·ml-1) were 622.53 ± 139.96 and 620.95 ± 1 17.36, Tmax (h)1.93 ± 0.18and 1.95 ± 0.15; respectively. MRT(h).5.74 ± 0.37 and 5.96 ± 0.45, AUC0-16(μg· h· L-1): 2848.24 ± 553.24 and 2962.38 ± 530. 13; The relative bioavailability (%) of test tablets was 97. 11 ± 11 .06. CONCLUSION: There were no significant difference between pharmacokinetic parameters for test and reference tablets. It was demonstrated the two preparations were bioequivalent by one two-sided tests.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2000年第4期298-300,共3页
The Chinese Journal of Clinical Pharmacology