论文部分内容阅读
目的:比较法莫替丁(famotidine,Fam)散剂和片剂的生物利用度和药代动力学。方法:10例健康志愿者分别单剂口服Fam散剂或片剂40mg,用反相高效液相色谱法测定血药和尿药浓度。结果:Fam散剂和片剂体内过程均符合开放性一室模型;散剂的相对生物利用度为103%。Fam散剂和片剂的tmax,cmax,t1/2k和AUC分别为(1.91±0.44),(2.54±0.40)h;(99.4±37.6),(87.0±29.5)ng/ml;(3.21±0.67),(2.49±0.56)h;(627±100),(607±177)h·ng/ml。结论:两种剂型的体内吸收和峰浓度无显著性差异(P>0.05),具有生物等效性;达峰时间具有明显的差异(P<0.05)。
OBJECTIVE: To compare the bioavailability and pharmacokinetics of famotidine (Fam) powders and tablets. Methods: A total of 10 healthy volunteers were given single oral dose of Fam or 40mg tablets respectively, and the concentrations of blood and urine were determined by reversed-phase high performance liquid chromatography. Results: Fam litter and tablet in vivo procedures were in line with the open-studio model; the relative bioavailability of the powder was 103%. The tmax, cmax, t1 / 2k and AUC of Fam powder and tablet were (1.91 ± 0.44), (2.54 ± 0.40) h, (99.4 ± 37.6), (87 .0 ± 29.5) ng / ml; (3.21 ± 0.67), (2.49 ± 0.56) h; (627 ± 100), (607 ± 177) h · ng / ml respectively. CONCLUSION: There is no significant difference in peak absorption and peak concentration between the two dosage forms (P> 0.05), which is bioequivalent. The peak time has significant difference (P <0.05).