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目的 :研究国产和进口亚叶酸钙片在 12名健康志愿者体内的相对生物利用度。方法 :同体交叉试验后 ,血样采用固相萃取后经 RP- HPL C法测定血浆中亚叶酸钙的浓度 ,计算两种片剂的主要药物动力学参数和相对生物利用度 ,并进行统计学分析。结果 :国产片和进口片单剂量 po后 ,tmax分别为 (2 .4± 0 .3)和 (2 .3± 0 .3) h,cmax分别为 (72 0± 96 )和 (72 0± 10 9.9) ng/ml,AUC0→ t分别为 (6 382 .3± 12 34.1)和 (6 2 87.7± 10 79.4) ng· h/ m l,AUC0→∞ 分别为 (7398.8± 1331.5 )和 (72 6 3.5±12 2 5 .3) ng· h/ m l,MRT0→ t分别为 (5 .88± 0 .17)和 (5 .84± 0 .31) h,T1 /2 分别为 (8.6 9± 1.0 9)和 (8.40± 1.2 1) h。国产片平均相对生物利用度为 (10 1.7± 9.6 ) %。结论 :两种片剂在健康志愿者体内为生物等效
Objective: To study the relative bioavailability of domestic and imported leucovorin tablets in 12 healthy volunteers. Methods: After the same-body crossover test, the concentration of leucovorin in plasma was determined by RP-HPL C method after solid-phase extraction. The main pharmacokinetic parameters and relative bioavailability of the two tablets were calculated and statistically analyzed . Results: After a single dose po of domestic and imported tablets, the tmax were (2. 4 ± 0. 3) and (2. 3 ± 0. 3) h respectively, and the cmax were (72 0 ± 96) and 10 9.9) ng / ml and AUC0 → t were (6 382.3 ± 12 34.1) and (6 2 87.7 ± 10 79.4) ng · h / ml respectively, and AUC0 → ∞ were (7398.8 ± 1331.5) and 3.5 ± 12.25.3 ng · h / ml, MRT0 → t were (5.88 ± 0.17) and (5.84 ± 0.31) h respectively, T1 / 2 were (8.69 ± 1.0 9) and (8.40 ± 1.2 1) h. The average relative bioavailability of domestic tablets was (10 1.7 ± 9.6)%. Conclusions: Both tablets are bioequivalent in healthy volunteers