国产加替沙星胶囊剂人体药动学及生物等效性研究

Studies on the pharmacokinetics and bioequivalence of domestic gatifloxacin capsules in healthy volunteers

目的 评价加替沙星国产胶囊剂和进口片剂在人体内是否生物等效。方法 采用高效液相色谱紫外检测法测定 2 0名健康受试者单剂量po 40 0mg加替沙星国产胶囊或进口片剂后 ,血浆中加替沙星的浓度。 结果 国产加替沙星胶囊剂和进口片剂的AUC0～ 36 均值分别为 (31 .60± 5 .45)和 (30 .37± 5 .74) μg·h·mL- 1 ,实测cmax均值分别为 (3 .32± 0 .55)和 (3 .37±0 .50 ) μg·mL- 1 ,实测tmax均值分别为 (1 .65± 0 .37)和 (1 .55± 0 .46)h ,国产加替沙星胶囊的相对生物利用度为 (1 0 4 .6±8.6) %。结论 经统计学分析 。

OBJECTIVE: To observe the bioavailability of domestic gatifloxacin capsules and imported tablets. METHOD: A single oral dose of 400 mg domestic capsules or imported tablets were given to 20 healthy volunteers in a randomized crossover study. The concentrations of gatifloxacin were determined by HPLC method. RESULTS: The main pharmacokinetics of the two products were as following: AUC0&middot36(31.60 ± 5.45) and (30.37 ± 5.74) μg &middot h &middot mL-1, cmax(3.32 ± 0.55) and (3.37 ± 0.50) μg &middot mL-1, t max(1.65 ± 0.37) and (1.55 ± 0.46) h, respectively. The relative bioavailability of domestic capsules to imported tablets was (104. 6 ± 8.6)%. CONCLUSION: There were no significant difference between the parameters of the two preparations(P > 0.05). The results demonstrated that the two preparations were bioequivalent.