| 摘要: |
| 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)。 |
| 关键词: 法莫替丁、散剂、片剂 药代动力学、生物等效性 |
| DOI： |
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| 基金项目: |
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| The evaluation of pharmacokinetics and bioequivalence of famotidine powder and tablets |
| 瞿华,沈意翔,张文斌,刘皋林 |
| () |
| Abstract: |
| Objective: To compare the bioavailability and pharmacokinetics of famotidine powder and tablets. Methods: Ten healthy volunteers were given a single oral dose of 40mg of famotidine power or tablet. The blood and urine drug levels were determined by reverse-phase HPLC method. Results: The data obtained from the HPLC were analysed automatically by a MCPKP program. The results showed that the curve of famotidine plasma concentration-time data was in line with the one-compartment open model. The relative-bioavailability of famotidine powder was 103%.The tmax,cmax,t1/2k and AUC of famotidine powder and tablets 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: The AUC and cmax of 2 formulations are bioequivalent. There is statistical difference in the tmax between 2 formulations. |
| Key words: famotidine powder tablet pharmacokinetic bioequivalence |
