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目的:研究加替沙星胶囊在健康人体的生物等效性。方法:20名健康男性志愿者随机交叉口服单剂量受试制剂加替沙星胶囊和参比制剂加替沙星片0．4 g,用高效液相色谱-荧光检测法测定加替沙星血浆浓度,计算药物动力学参数,评价胶囊和片剂的生物等效性。结果:加替沙星胶囊剂与片剂的t_max分别为(2．27±0．71)和(2．11±0．89)h;C_(max)分别为(4．00±1．22)和(4．05±0．61)mg·L~(-1);AUC 0-36分别为(32．96±4．68)和(34．00±4．34)mg·h·L~(-1)。胶囊剂的相对生物利用度为(96．98±8．63)％,主要药动学参数经统计学分析无统计学差异(P>0．05)。结论:两制剂生物等效。
Objective: To study the bioequivalence of gatifloxacin capsules in healthy volunteers. Methods: Twenty healthy male volunteers were randomized to receive a single dose of gatifloxacin and 0.4 g of gatifloxacin as randomized crossover test. Gatifloxacin plasma was determined by high performance liquid chromatography-fluorescence detection Concentration, calculate pharmacokinetic parameters, and evaluate the bioequivalence of capsules and tablets. Results: The t_max of gatifloxacin capsules and tablets were (2.27 ± 0.71) and (2.11 ± 0.89) h, respectively; the C max values were (4.00 ± 1.22 ) And (4.05 ± 0.61) mg · L -1, respectively; AUC 0-36 were (32.96 ± 4.68) and (34.00 ± 4.34) mg · h · L ~ (-1). The relative bioavailability of capsules was (96.98 ± 8.63)%. There was no significant difference in the main pharmacokinetic parameters by statistical analysis (P> 0.05). Conclusion: The two formulations are bioequivalent.