阿莫西林胶囊的人体相对生物利用度研究

Study on Bioequivalence of Amoxicillin Capsule

目的研究国产阿莫西林胶囊的相对生物利用度。方法以国产已上市的阿莫西林胶囊(阿莫仙)为参比制剂,采用高效液相色谱法测定人血浆中阿莫西林浓度,用3P97软件计算药代动力学参数,并计算生物利用度。结果受试制剂和参比制剂的药代动力学参数无统计学差异,受试制剂阿莫西林胶囊的相对生物利用度为(98.8±18.5)%。结论阿莫西林胶囊受试制剂与参比制剂具有生物等效性。

Objective To study the relative bioavailability of a domestic amoxicillin capsule, Methods The amoxicillin in human serum was determined with high-performance liquid chromatography. The study was carried out in 20 healthy volunteers with amoxicillin capsule as the reference formulation, To calculate parameters of pharmacokinetics and bioavailability with 3P97 procedure. Results The phmacokinetic parameters of tested amoxicillin capsule and reference capsule showed no significant differences between two products （P〉0.05）. The relative bioavailability of tested capsule was （98.8±18.5）%. Conclusion The tested products of amoxicillin capsule and the reference products of amoxicillin capsule are bioequivalent.