摘要
目的:研究国产和进口苯磺酸氨氯地平片在健康人体的相对生物利用度和生物等效性。方法:采用两制剂双周期交叉试验设计。20名男性健康志愿者随机分别服用10mg苯磺酸氨氯地平试验药(国产)或对照药(进口),采用LC-MS测定血浆中氨氯地平质量浓度。并计算药动学参数和相对生物利用度,据此对两种制剂作出等效性评价。结果:单剂量口服10mg苯磺酸氨氯地平试验药和对照药的药动学参数:AUC0-120分别为(306.0±60.7)μg.h.L-1和(315.1±62.7)μg.h.L-1;AUC0-∞分别为(330.3±59.8)μg.h.L-1和(341.7±67.2)μg.h.L-1;Cmax分别为(7.6±1.7)μg.L-1和(7.8±1.6)μg.L-1;tmax分别为(7.7±2.2)h和(7.4±2.1)h;t1/2分别为(35.4±6.3)h和(36.4±5.1)h;国产苯磺酸氨氯地平片的相对生物利用度为(98.3%±13.2%)(F0-120)和(98.0%±12.5%)(F0-∞)。结论:经统计学分析,两种制剂具有生物等效性。
OBJECTIVE To study the pharmacokinetics profiles and bioequivalence of domestic and imported amlodipine besylate tables in healthy volunteers. METHODS A single oral dose of 10 mg domestic or imported amlodipine besylate tables were given to 20 healthy male volunteers in an open randomized crossover design. Concentrations of amlodipine in plasma were determined by LC-MS. The pharmacokinetic parameters and relative bioavailability were calculated by DAS 2.0 program to evaluate the bioequivalence of the two preparations. RESULTS The main pharmacokinetic parameters of the two preparations were as follows： AUG0-120 were （ 306. 1 ± 60. 7） μg·h·L^-1 and （ 315. 1 ± 62.7）μg·h·L^-1, AUG0-∞ were （ 330. 3 ± 59. 8 ） μg·h·L^-1 and （341.7 ± 67. 2） μg·L^-1 ;Cmax were （7. 6 ± 1.7 ） μg·L^-1 and （7.8 ± 1.6） μg·L^-1 ; tmax were （7. 7 ± 2. 2） h and （7. 4 ± 2. 1） h;t1.2 .were （35. 4± 6. 3 ） h and （36. 4 ± 5. 1 ） h respectively. The relative bioavailability of domestic to imported tablets were 98. 3% ± 13. 2 G （F0-120） and 98. 0% ± 12. 5 % （F0-∞）. CONCLUSION The results of the statistical analysis show that the two preparations are bioequivalent.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2007年第2期185-187,共3页
Chinese Journal of Hospital Pharmacy
