国产加替沙星胶囊剂人体药动学及生物等效性研究

 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20名健康受试者单剂量po400 mg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AUC_0～36均值分别为(31.60±5.45)和(30.37±5.74)μg·h·mL_-1, 实测c_max均值分别为(3.32±0.55)和(3.37±0.50) μg·mL_-1, 实测t_max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(104.6±8.6)%。结论经统计学分析，被试制剂和参比制剂具有生物等效性。

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

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: AUC_0～36(31.60±5.45) and (30.37±5.74) μg·h·mL_-1,c_max(3.32±0.55) and (3.37±0.50) μg·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.