目的 :研究奥美拉唑肠溶胶囊在健康人体内的药代动力学和相对生物利用度。方法 :采用 HPL C法测定 8名男性健康志愿受试者随机交叉一次口服康恩贝产 (受试品 ,商品名金奥康 )和瑞典产 (参比品 ,商品名洛赛克 )奥美拉唑胶囊各 40 mg的血药浓度 ,进行人体生物利用度研究。结果 :两种胶囊的药—时曲线和药代动力学特征均符合—室开放模型。测得主要药代动力学参数为 :试验胶囊和参比胶囊从胃肠吸收的滞后的时间 (L.T)分别为 1.3 6± 0 .92 h和 0 .90± 0 .42 h;Cmax分别为 0 .2 8±0 .2 0 mg/L 和 0 .3± 0 .2 0 mg/L;;Tmax分别为 3 .69± 1.46h和 2 .44± 0 .74h;AUC分别为 1.71± 1.2 0 mg/L· h和 2 .44±0 .74mg/L· h;消除半衰期分别为 2 .3 4± 0 .61h和 2 .2 2± 0 .70 h;结论 :奥美拉唑试验胶囊的相对生物利用度为 10 2 .5± 16.1%。经统计分析与参比胶囊比较为等效 Objective: To study the pharmacokinetics and relative bioavailability of omeprazole enteric-coated capsules in healthy volunteers. METHODS: Eight healthy male volunteers were randomized to a crossover oral concomitant oral administration of testosterone (brand name Aokang) and Swedish (reference product Losec) Omela Azole capsules of 40 mg of blood drug concentration, bioavailability of the study. RESULTS: The drug-time curves and pharmacokinetic characteristics of the two capsules were in agreement with the open chamber model. The main pharmacokinetic parameters were measured as follows: the lag time (LT) of the test capsule and the reference capsule absorbed from the gastrointestinal tract were 1.3 6 ± 0 .92 h and 0 .90 ± 0 .42 h, respectively; Cmax was 0 .2 8 ± 0.2 mg / L and 0.3 ± 0.2 0 mg / L ;; Tmax were 3.69 ± 1.46 h and 2.44 ± 0.74 h, respectively; AUC was 1.71 ± 1.2 0 mg / L · h and 2.44 ± 0.74mg / L · h; elimination half-lives were respectively 2.34 ± 0.61h and 2.2 ± 0.70 h; Conclusion: The omeprazole capsule The relative bioavailability was 102.5 ± 16.1%. By statistical analysis and reference capsules more equivalent