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目的:研究氨酚咖黄烷胺的药物动力学和生物等效性。方法:按双周期随机交叉试验设计,24名健康男性受试者分别单次口服受试试剂和参比试剂后,HPLC法测定血浆中对乙酰氨基酚、咖啡因的浓度,HPLC-MS/MS法测定血浆中金刚烷胺的浓度。结果:口服受试试剂和参比试剂后,对乙酰氨基酚的t_(1/2)分别为(3.93±1.66)和(3.56±1.38)h,C_(max)分别为(6.301 2±0.840 8)和(6.695 6±1.260 0)μg·ml~(-1),t_(max)分别为(0.79±0.42)和(0.77±0.59)h,AUC_(0-t)分别为(26.2±5.4)和(27.0±5.6)μg·h·ml~(-1);对乙酰氨基酚的相对生物利用度为(98.1%±15.1)%。咖啡因的t_(1/2)分别为(6.50±2.53)和(6.70±2.37)h,C_(max)分别为(795.1±182.5)和(811.8±194.1)ng·ml~(-1),t_(max)分别为(0.89±0.61)和(0.98±0.69)h,AUC_(0-t)分别为(7 008±2 615)和(7 330±2 669)ng·h·ml~(-1);咖啡因的相对生物利用度为(96.7%±18.7)%。金刚烷胺的t_(1/2)分别为(13.29±4.04)和(11.76±3.63)h,C_(max)分别为(295.3±80.5)和(303.0±72.4)ng·ml~(-1),t_(max)分别为(2.10±1.13)和(2.13±1.17)h,AUC_(0-t)分别为(4 158±1 653)和(4 097±1 366)ng·h·ml~(-1);金刚烷胺的相对生物利用度为(104.5±32.7)%。结论:受试试剂与参比试剂真有生物等效性。
Objective: To study the pharmacokinetics and bioequivalence of paracetamol yellow amine. Methods: According to the double-cycle randomized crossover design, 24 healthy male subjects were tested for the concentration of acetaminophen and caffeine by HPLC after single oral administration of test agent and reference reagent. HPLC-MS / MS Method for the determination of amantadine in plasma. Results: The t_ (1/2) of paracetamol was (3.93 ± 1.66) and (3.56 ± 1.38) h, respectively, and the max was (6.301 2 ± 0.840 8 ) And (6.695 6 ± 1.260 0) μg · ml -1, t max respectively were (0.79 ± 0.42) and (0.77 ± 0.59) h and AUC 0-t were (26.2 ± 5.4) And (27.0 ± 5.6) μg · h · ml -1, respectively. The relative bioavailability of acetaminophen was (98.1% ± 15.1)%. The t_ (1/2) of caffeine was (6.50 ± 2.53) and (6.70 ± 2.37) h, respectively, and the C max were (795.1 ± 182.5) and (811.8 ± 194.1) ng · ml -1, t max was 0.89 ± 0.61 and 0.98 ± 0.69 h, and AUC 0-t was (7 008 ± 2 615) and (7 330 ± 2 669) ng · h · ml ~ (- 1); The relative bioavailability of caffeine was (96.7% ± 18.7)%. The t_ (1/2) of amantadine were (13.29 ± 4.04) and (11.76 ± 3.63) h, respectively, and the max was 295.3 ± 80.5 and 303.0 ± 72.4 ng · ml -1, , t max respectively were (2.10 ± 1.13) and (2.13 ± 1.17) h and AUC 0-t were (4 158 ± 1 653) and (4 097 ± 1 366) ng · h · ml ~ -1). The relative bioavailability of amantadine was (104.5 ± 32.7)%. Conclusion: The test and reference reagents are truly bioequivalent.