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目的 :研究富马酸奎的平片的药动学及相对生物利用度。方法 :受试者交叉口服单剂量 (1 0 0mg)国产片与进口片 ,用高效液相色谱法测定血药浓度。结果 :两种片剂的主要药动学参数 :Tmax分别为 (1 .7± 0 .8)h与 (1 .6± 0 .7)h ,Cmax分别为(1 0 0 .4± 1 8.9) μg·L-1 与 (1 0 0 .0± 1 7.8) μg·Lˉ1 ,AUC0 -t分别为 (2 4 6 .8± 2 9.4 ) μg·Lˉ1 ·h与 (2 4 4 .7± 2 8.8) μg·L-1 ·h ,AUC0 -∞分别为 (2 5 0 .7± 30 .2 ) μg·L-1 ·h与 (2 4 8.9± 2 9.6 ) μg·L-1 ·h ,T1 / 2 分别为 (1 .8± 0 .5 )h与 (1 .8± 0 .4 )h ,国产片相对于进口片的生物利用度为 (1 0 1 .9± 7.4 ) %。结论 :两种制剂具有生物等效性。
Objective: To study the pharmacokinetics and relative bioavailability of quetiapine fumarate tablets. Methods: A single dose (100 mg) of homemade tablets and imported tablets were taken at the crossover point of the subjects and plasma concentrations were determined by high performance liquid chromatography. RESULTS: The main pharmacokinetic parameters of the two tablets were: Tmax = (1.7 ± 0.8) h and (± 0.6 ± 0.7) h, respectively, and the Cmax values were (104 ± 1 8.9 ) μg · L-1 and (100 ± 1 7.8) μg · Lˉ1 and AUC0-t were (24.68 ± 2 9.4) μg · Lˉ1 · h and (24.4 ± 2) 8.8) μg · L-1 · h and AUC0 -∞ were (250.7 ± 30.2) μg · L-1 · h and (24.9 ± 2.9) μg · L-1 · h, T1 / 2 was (1.8 ± 0.5) h and (1.8 ± 0.4) h, respectively, and the bioavailability of domestic tablets relative to imported tablets was (1 0 1 .9 ± 7.4)%. Conclusion: Both formulations are bioequivalent.