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目的:研究牛磺酸颗粒在健康人体的药动学和相对生物利用度并求证其生物等效性。方法:男性健康志愿者20名,随机交叉单剂量口服牛磺酸颗粒受试和参比制剂各1.6g,采用高效液相色谱-荧光法测定血清中牛磺酸的浓度。应用DAS软件计算药动学参数和相对生物利用度,评价其生物等效性。结果:口服受试和参比制剂后的主要药动学参数:试验制剂t1/2(51.0±8.8)min和(56.4±11.6)min;tmax(38.0±12.0)min,(39.5±10.0)min;Cmax(54.0±8.4)mg.L-1,(54.87±9.47)mg.L-1;AUC0-360min(5296.9±1123.5)mg.min.L-1,(5123.8±806.6)mg.min.L-1;AUC(0-∞(5552.1±1149.6)mg.min.L-1,(5421.9±820.7)mg.min.L-1。受试制剂与参比制剂比较的相对生物利用度F为(105.0±26.3)%。结论:两制剂具有生物等效性。
Objective: To study the pharmacokinetics and relative bioavailability of taurine granules in healthy volunteers and to verify their bioequivalence. Methods: Twenty healthy male volunteers were randomized to receive crossover single oral doses of taurine granules and reference preparations of 1.6 g each. Serum taurine concentrations were determined by high performance liquid chromatography-fluorescence spectroscopy. The pharmacokinetic parameters and relative bioavailability were calculated by DAS software to evaluate the bioequivalence. Results: The main pharmacokinetic parameters after oral administration and reference preparation were: t1 / 2 (51.0 ± 8.8) min and (56.4 ± 11.6) min, tmax (38.0 ± 12.0) min and (39.5 ± 10.0) min ; Cmax (54.0 ± 8.4) mg.L-1, (54.87 ± 9.47) mg.L-1; AUC0-360min (5296.9 ± 1123.5) mg.min.L-1, (5123.8 ± 806.6) mg.min.L -1; AUC (0-∞ (5552.1 ± 1149.6) mg.min.L-1, (5421.9 ± 820.7) mg.min.L-1. The relative bioavailability F of the test formulation compared with the reference formulation was 105.0 ± 26.3)%. Conclusion: The two preparations are bioequivalent.