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目的:研究辛伐他汀片在健康人体的药物动力学及生物等效性。方法:20名健康志愿者随机双交叉、单剂量口服受试制剂和参比制剂20 mg,用LC-MS/MS法测定人血浆中辛伐他汀的浓度。使用DAS软件拟合计算药物动力学参数和相对生物利用度,评价两制剂的生物等效性。结果:受试制剂和参比制剂药物动力学参数:C_(max)分别为(3.09±1.57),(3.48±1.95)ng·ml~(-1);t_(max)分别为(1.68±0.96),(1.31±0.74)h;t_(1/2)分别为(5.65±2.48),(5.47±2.55)h;AUC_(0-24h)分别为(12.52±5.59),(12.80±5.07)ng·ml~(-1)·h;AUC_(0-∞)分别为(13.41±5.95),(13.70±5.24)ng·ml~(-1)·h。受试制剂相对于参比制剂的生物利用度为(99.0±23.9)%。结论:两种制剂具有生物等效性。
Objective: To study the pharmacokinetics and bioequivalence of simvastatin tablets in healthy volunteers. Methods: Twenty healthy volunteers were randomly divided into two groups: a single oral dose of 20 mg and a single oral dose of 20 mg. The concentrations of simvastatin in human plasma were determined by LC-MS / MS. The bioequivalence of both formulations was evaluated using the DAS software fitting calculation of pharmacokinetic parameters and relative bioavailability. Results: The pharmacokinetic parameters of test preparation and reference preparation were: C max 3.09 ± 1.57 and 3.48 ± 1.95 ng · ml -1, respectively; t max was 1.68 ± 0.96 ), (1.31 ± 0.74) h and (t 1/2) were (5.65 ± 2.48) and (5.47 ± 2.55) h, respectively. The AUC 0-24h were (12.52 ± 5.59) and (12.80 ± 5.07) ng · Ml -1 · h · AUC 0 -∞ were 13.41 ± 5.95 and 13.70 ± 5.24 ng · ml -1 · h, respectively. The bioavailability of the test formulation relative to the reference formulation was (99.0 ± 23.9)%. Conclusion: Both formulations are bioequivalent.