摘要
目的:研究更昔洛韦分散片的人体生物等效性。方法:采用双周期交叉试验设计,18名健康男性受试者随机交叉单剂量口服更昔洛韦分散片(试验制剂)和更昔洛韦胶囊(参比制剂)1000mg,采用HPLC-MS/MS法测定人血浆中更昔洛韦的血药浓度,利用SPSS10.0统计软件计算药代动力学参数,评价两制剂的生物等效性。结果:试验制剂和参比制剂更昔洛韦的tmax分别为(1.6±0.5)和(1.9±0.5)h,Cmax分别为(624.4±228.6)和(587.4±158.9)ng·mL-1,t1/2分别为(5.2±1.7)和(5.4±1.9)h,AUC0-18分别为(3493.5±1064.5)和(3594.8±1033.6)ng·h·mL-1,AUC0-∞分别为(3804.6±992.0)和(3920.9±1000.0)ng·h·mL-1。以AUC0-18计算,试验制剂中更昔洛韦的相对生物利用度为(97.4±8.7)%。结论:两种制剂生物等效。
Objective： To study the relative bioequivalence of ganciclovir dispersible tablet in human body. Methods： The plasma concentrations of ganeielovir in 18 healthy male volunteers were determined by HPLC-MS/MS methods after being orally administered with single dose of 1 000 nag test and reference preparations by randomized crossover way. The pharmaeokinetic parameters and the relative bioequivalenee of the two preparations of ganciclovir were calculated by SPSS10.0 software. Results： The main pharmaeokinetic parameters of ganciclovir were as follows： tmax were （1.6 ±0.5） and （1.9 ±0.5） h, Cmax were （624.4 ± 228.6） and （587.4 ± 158.9） ng·mL^-1, t1/2 were （5.2 ± 1.7） and （5.4 ± 1.9） h, AUC0-18 were （3 493.5 ± 1 064.5） and （3 594.8 ± 1 033.6） ng ng·mL^-1; AUC0-∞ were （3 804.6± 992.0） and （3 920.9 ± 1 000.0） ng·mL^-1. The relative bioavailability of ganciclovir dispersible tablets was （97.4 ± 8.7）%. Conclusion： Ganciclovir dispersible tablet and capsule are bioequivalent.
出处
《中国药物应用与监测》
CAS
2009年第1期17-20,共4页
Chinese Journal of Drug Application and Monitoring
