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目的:研究评价法莫替丁缓释片在健康人体内的生物利用度。方法:以高效液相色谱法测定血药浓度,用3P87程序处理数据。结果:单剂量给药,本品的达峰时间为(7.12±0.40)h,峰浓度为(58.69±4.36)ng·ml-1,相对生物利用度为(117.0±8.9)%;多剂量给药达稳态后,本品的峰浓度为(70.72±4.61)ng·ml-1,血药浓度波动度为(121.6±11.4)%,相对生物利用度为(117.9±23.46)%。结论:法莫替丁缓释片与市售普通片基本生物等效。
Objective: To evaluate the bioavailability of famotidine sustained-release tablets in healthy volunteers. Methods: The plasma concentration was determined by HPLC, and the data was processed by 3P87 program. Results: The peak time of this product was (7.12 ± 0.40) h, the peak concentration was (58.69 ± 4.36) ng · ml-1, the relative bioavailability was (117 .0 ± 8.9)%. After the multi-dose administration reached steady state, the peak concentration of this product was (70.72 ± 4.61) ng · ml-1, and the fluctuation of plasma concentration was (121.6 ± 11.4)%, the relative bioavailability was (117.9 ± 23.46)%. Conclusion: Famotidine sustained release tablets are commercially bioavailable equivalent to commercial tablets.