摘要
目的:研究氨氯地平进口片和国产片在健康志愿者体内的药代动力学及相对生物利用度。方法:单次口服10mg氨氯地平片,用高效液相色谱法测定血药浓度,3p97程序处理数据。结果:两种制剂降压平稳,72h内均有降压作用。受试制剂和参比制剂的主要药代动力学参数,峰时间(Tmax)分别为(5.22±1.70),(5.89±1.28)h;峰浓度(Cmax)分别为(6.98±1.30),(6.95±1.15)ng/mL;消除半衰期[T1/2(ke)]分别为(38.02±7.30),(41.03±11.62)h;药时曲线下面积(AUC0~72)分别为(244.96±55.80),(243.68±46.87)ng.h/mL;氨氯地平国产片的相对生物利用度平均为(100.7±12.5)%。结论:两种制剂生物等效。
Objective: To study the pharmacokinetics and relative bioavailability of imported and domestic arnlodipine besylate tablets in healthy volunteers. Methods: A single oral dose of 10 mg amlodipine tablets was given to each volunteers. The concentrations of amlodipine in serum were determined by HPLC. 3p97 program was used for the calculation of the pharmacokinetic parameters and relative bioavailability. Results: Blood pressure decrease in two preparations is smooth and steady. The blood pressure lowering effect is maintained for 72 h. A two- compartment model were used for the best fitting of concentration- time data. The main pharmacokinetic parameters were as follows: for test and reference drugs, Tmax were (5.22±1.70)h and (5.89±1.28)h, Cmax were (6.98±1.30)ng/mL and (6.95±1.15)ng/mL, T1/2(ke) were (38.02 ± 7.30)h and (41.03 ± 11.62)h, AUC0-72 were (244.96 ± 55.80)ng·h/mL and (243.68 ± 46.87)ng·h/mL, respectively. The relative bioavailability of domestic tablets was (100.7±12.5)%. Conclusion: Statistic analysis shows that the imported and domestic amlodipine tablets are bioequivalent.
出处
《中国药业》
CAS
2005年第9期25-27,共3页
China Pharmaceuticals