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目的:比较两种奥美拉唑肠溶胶囊的人体相对生物利用度,并做出生物等效性评价,以考察试验制剂的药品质量。方法:按照两制剂两周期随机交叉设计,19名男性健康志愿者单剂量口服试验胶囊(20 mg×2)和参比胶囊(40 mg)。采用HPLC法测定血浆奥美拉唑浓度。运用DAS2.0软件计算药动学参数,并进行统计学分析。结果:单剂量口服40 mg的奥美拉唑肠溶试验胶囊和参比胶囊后,AUC_(0→12)分别为(3 184.81±2 055.44)ng·h·ml~(-1)和(3 062.46±1 957.74)ng·h·ml~(-1),AUC_(0→∞)分别为(3 361.55±2 370.29)ng·h·ml~(-1)和(3 186.89±2 042.69)ng·h·ml~(-1);C_(max)分别为(1 066.44±482.99)ng·ml~(-1)和(1 072.99±472.30)ng·ml~(-1);T_(max)分别为(2.50±0.82)h和(2.37±0.72)h;受试胶囊对参比胶囊平均相对生物利用度为(107.33±23.44)%。结论:试验胶囊与参比胶囊具生物等效性。
OBJECTIVE: To compare the relative bioavailability of two omeprazole enteric-coated capsules in humans and to evaluate the bioequivalence of the omeprazole enteric-coated capsules in order to investigate the quality of the drugs tested. Methods: According to the randomized crossover design of two preparations, 19 male volunteers were given a single dose oral test capsule (20 mg × 2) and reference capsule (40 mg). Plasma omeprazole concentrations were determined by HPLC. Pharmacokinetic parameters were calculated by DAS2.0 software and analyzed statistically. RESULTS: After a single oral dose of 40 mg omeprazole enteric-coated test capsule and reference capsule, AUC_ (0 → 12) were (3 184.81 ± 2 055.44) ng · h · ml -1 and (3) (2 361.55 ± 2 370.29) ng · h · ml -1 and (3 186.89 ± 2 042.69) ng · h -1 · ml -1, respectively · H · ml -1 and C max were (1066.44 ± 482.99) ng · ml -1 and (1072.99 ± 472.30) ng · ml -1, respectively. (2.50 ± 0.82) h and (2.37 ± 0.72) h, respectively. The average relative bioavailability of test capsule to reference capsule was (107.33 ± 23.44)%. Conclusion: The bio-equivalence of test capsule and reference capsule.