论文部分内容阅读
目的:研究国产加替沙星片在健康志愿者中的药物动力学及生物等效性和安全性。方法:选择24名健康成年男性受试者,随机分为2组,单次空腹口服国产或进口片剂400mg,采用HPLC法测定其血药和尿药浓度。结果:单剂量空腹口服国产和进口加替沙星片剂后体内过程均符合血管外二室模型,C_(max)分别为(4.15±1.04)mg·L~(-1)和(3.95±0.75)mg·L~(-1),t_(max)分别为(0.75±0.30)h和(0.75±0.32)h,t_(1/2)为(6.77±1.58)h和(7.18±0.98)h,AUC_(0-t)分别为(31.83±3.84)mg·h·L~(-1)和(32.41±3.81)mg·h·L~(-1)。48 h内平均累积尿排出率分别为(79.53±5.79)%和(79.89±6.09)%。结论:国产片剂与进口片剂相比,主要药物动力学参数经统计学处理均无显著性差异,其相对生物利用度为(98.41±7.62)%。
Objective: To study the pharmacokinetics, bioequivalence and safety of domestic gatifloxacin tablets in healthy volunteers. Methods: Twenty-four healthy adult male subjects were randomly divided into two groups. The single oral dose of 400 mg domestic and imported tablets was determined by fasting plasma and urine concentration. Results: After oral administration of gatifloxacin tablets, both fasting and oral administration of a single dose of fasting gavage resulted in an extravascular extracorporeal compartment model with C max of (4.15 ± 1.04) mg · L -1 and (3.95 ± 0.75) ) (mg · L -1, t max) were (0.75 ± 0.30) h and (0.75 ± 0.32) h, t 1/2 was 6.77 ± 1.58 h and (7.18 ± 0.98) h respectively (31.83 ± 3.84) mg · h · L -1 and (32.41 ± 3.81) mg · h · L -1 for AUC_ (0-t), respectively. The average cumulative urinary excretion rates within 48 h were (79.53 ± 5.79)% and (79.89 ± 6.09)%, respectively. CONCLUSION: Compared with imported tablets, the main pharmacokinetic parameters of domestic tablets showed no significant difference by statistical analysis, and the relative bioavailability was (98.41 ± 7.62)%.