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目的研究单剂量口服两种扑热息痛异型片500mg 的药代动力学和相对生物利用度。方法10名男性健康志愿者按照随机、交叉试验设计 ,采集服药后0.5,1,1.5,2,3,4,6,8,10h的血样本。用HPLC方法测定扑热息痛的血药浓度。结果两种制剂的药 -时曲线符合口服吸收有滞后时间的一级动力学一室模型。受试制剂扑热息痛薄膜包衣异型片(康司达)的主要药代动力学参数 :Cmax=5.51±1.24mg/L,Tpeak=1.03±0.43h,T 1/2ka=0.27±0.16h,T1/2ke=2.60±0.51h,AUC0～t=23.69±4.08mg/h·L -1,MRT=3.65±0.22h。结论受试制剂相对于参比制剂的生物利用度为102.5±13.3 % ,受试制剂(康司达)与参比制剂扑热息痛片生物等效
Objective To study the pharmacokinetics and relative bioavailability of 500 mg single-dose oral Paracetamol tablets 500 mg. Methods Ten male healthy volunteers were randomly assigned to a crossover trial to collect blood samples at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 h after treatment. The plasma concentration of paracetamol was determined by HPLC method. Results The drug-time curves for both formulations coincided with a first-order kinetic one-compartment model with a lag time orally absorbed. The main pharmacokinetic parameters of the test preparation paracetamol coated film (Contac): Cmax = 5.51 ± 1.24 mg / L, Tpeak = 1.03 ± 0.43 h, T 1/2 ka = 0.27 ± 0.16 h, T1 / 2ke = 2.60 ± 0.51h, AUC0 ~ t = 23.69 ± 4.08mg / h · L -1, MRT = 3.65 ± 0.22h. Conclusion The bioavailability of the test preparation relative to the reference preparation was 102.5 ± 13.3%. The test preparation (Constable) and the reference preparation paracetamol tablet were bioequivalent