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目的:研究理舒达(辛伐他汀胶囊)的人体药动学和相对生物利用度。方法:采用双周期随机交叉试验设计。分别给予10例男性健康受试者理舒达或对照药(进口辛伐他汀片)20mg后,采用GC-MS检测法测定血浆中药物浓度。结果:试验药与对照药的主要药动学参数Cmax,Tmax,CL/F,t1/2,AUC0-24和AUC0-∞分别为(2.49±0.57)和(2.58±0.50)μg·L-1;(3.2±0.4)和(3.1±0.3)h;(2.08±0.59)×103和(2.17±0.47)×103L·h-1;(6.20±0.64)和(5.74±0.67)h;(18.20±4.06)和(17.84±3.59)μg·h·L-1;(19.32±3.59)和(19.80±4.05)μg·h·L-1。试验药的相对生物利用度F为(101.9±8.6)％。结论:试验药理舒达与对照药具有生物等效性。
OBJECTIVE: To study the pharmacokinetics and relative bioavailability of lisustat (simvastatin capsules). Methods: Double-cycle randomized crossover design. Ten cases of male healthy subjects Risumida or control drug (imported simvastatin tablets) 20mg, using GC-MS detection of plasma concentrations of drugs. Results: The main pharmacokinetic parameters Cmax, Tmax, CL / F, t1 / 2, AUC0-24 and AUC0-∞ were (2.49 ± 0.57) and (2.58 ± 0.50) μg · L -1 ; (3.2 ± 0.4) and (3.1 ± 0.3) h; (2.08 ± 0.59) × 103 and (2.17 ± 0.47) × 103L · h-1; (6.20 ± 0.64) and 4.06) and (17.84 ± 3.59) μg · h · L-1; (19.32 ± 3.59) and (19.80 ± 4.05) μg · h · L-1, respectively. The relative bioavailability of test drug F was (101.9 ± 8.6)%. Conclusions: The experimental pharmacology of Suda is bioequivalent to the reference drug.