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目的 :比较国产和进口泮托拉唑肠溶片的相对生物利用度。方法 :8名健康男性受试者交叉 po单剂量国产和进口泮托拉唑肠溶片 40mg ,采用HPLC测定血浆中泮托拉唑浓度。 结果 :国产及进口制剂的体内药动学主要参数分别为 :cmax为(2 932 .3± 6 6 5 .8)和 (32 5 1.9± 731.4) μg·L-1;tmax为 (2 .9± 0 .7)和 (2 .9± 0 .6 )h ;AUC0～∞ 为 (992 0 .7± 5 2 5 0 .9)和 (10 890 .1±6 0 15 .6 ) μg·h·L-1;t1/2 为 (1.8± 0 .4)和 (2 .1± 0 .4)h ;MRT为 (4.8± 1.0 )和 (4.7± 0 .7)h。国产制剂的平均相对生物利用度为 (92 .8± 10 .1) %。结论 :经统计学分析 ,两种制剂为生物等效制剂。
OBJECTIVE: To compare the relative bioavailability of pantoprazole enteric-coated tablets between domestic and imported. Methods: Eight healthy male subjects were crossed with a single dose of pantoprazole enteric-coated tablets 40mg, and plasma concentrations of pantoprazole were determined by HPLC. Results: The main pharmacokinetic parameters of domestic and imported preparations were as follows: cmax (2 932.3 ± 6 6 5 .8) and (32 5 1.9 ± 731.4) μg · L -1; tmax was (2.9 ± 0 .7) and (2.9 ± 0.6) h; AUC0 ~ ∞ was (992 ± 0.725 ± 0.9) and (10 890 ± 1) · L-1; t1 / 2 was (1.8 ± 0.4) and (2.1 ± 0.4) h; MRT was (4.8 ± 1.0) and (4.7 ± 0.7) h. The average relative bioavailability of domestic preparations was (92 .8 ± 10 .1)%. Conclusion: According to statistical analysis, the two preparations are bioequivalent.