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目的:研究泮托拉唑钠肠溶胶囊的相对生物利用度。方法:采用随机、开放、双周期交叉试验设计。18名健康志愿者分别单剂量口服40 mg参比或试验制剂。采用HPLC法测定给药后不同时间的泮托拉唑血药浓度。结果:参比制剂和试验制剂中的泮托拉唑C_(max)分别为(2741．6±1726．4)和(2622．3±1417．5)μg·L~(-1);t_(max)为(2．6±0．7)h和(2．4±0．9)h;t_(1／2)为(1．9±0．5)h和(2．0±0．6)h;AUC_(0-10h)为(6510．0±3585．2)和(6350．9±3035．4)μg·h·L~(-1)。受试制剂的相对生物利用度为(99．9±12．5)％。结论:试验制剂与参比制剂具有生物等效性。
Objective: To study the relative bioavailability of pantoprazole sodium enteric-coated capsules. Methods: Randomized, open, double-cycle crossover design. Eighteen healthy volunteers were given a single oral dose of 40 mg reference or test preparation. The plasma concentration of pantoprazole was determined by HPLC at different times after administration. Results: The maximal values of pantoprazole in reference preparation and test preparation were (2741.6 ± 1726.4) and (2622.3 ± 1417.5) μg · L -1, t_ ( (2.6 ± 0.7) h and (2.4 ± 0.9) h respectively; t 1/2 (1.9 ± 0.5) h and (2.0 ± 0) 6) h; AUC_ (0-10h) was (6510.0 ± 3585.2) and (6350.9 ± 3035.4) μg · h · L -1, respectively. The relative bioavailability of the test preparation was (99.9 ± 12.5)%. Conclusion: The test preparation and the reference preparation are bioequivalent.