论文部分内容阅读
目的 考察头孢呋辛酯干混悬剂的人体相对生物利用度及生物等效性 ,从而评价其临床疗效。方法 本研究以市售的进口头孢呋辛酯片剂 (西力欣 )为对照 ,选用 2 0名健康志愿受试者 ,进行了随机的 2周期交叉实验。以HPLC测定血药浓度并计算药动学参数及生物利用度 ,进而对主要动力学参数进行统计学分析。结果 2 0名受试者交叉po单剂量头孢呋辛酯干混悬剂和西力欣片 (2 5 0mg)后两者的主要药动学参数较接近 ,头孢呋辛酯干混悬剂的相对生物利用度 (F)达 92 .88%。主要参数的方差分析和双单侧t检验结果表明 ,头孢呋辛酯干混悬剂和西力欣片的AUC0～inf之间无显著性差异 (P >0 .0 5 ) ,91%置信区间在 81.6 %～ 97.2 %之间 ;两种制剂的cmax之间也无显著性差异 (P >0 .0 5 ) ,90 %置信区间为 93.6 %～ 12 1%。结论 头孢呋辛酯干混悬剂与西力欣片具生物等效性。
OBJECTIVE To investigate the relative bioavailability and bioequivalence of cefuroxime axetil suspension in human and to evaluate its clinical efficacy. Methods In this study, commercially available imported cefuroxime axetil tablets (Xili Xin) as a control, the selection of 20 healthy volunteers were randomized two-cycle crossover experiment. The plasma concentration was determined by HPLC and the pharmacokinetic parameters and bioavailability were calculated. Then the main kinetic parameters were statistically analyzed. Results The main pharmacokinetic parameters of 20 subjects after crossover po single-dose cefuroxime axetil suspension and xilixin tablets (250 mg) were close, and cefuroxime axetil suspension The relative bioavailability (F) was 92.88%. Analysis of variance (ANOVA) and one-sided t-test showed that there was no significant difference (P> 0.05) between the AUC0 ~ inf of cefuroxime axetil suspension and celexifloxacin tablet, 91% confidence interval Between 81.6% and 97.2%. There was also no significant difference in cmax between the two preparations (P> 0.05) and the 90% confidence interval was 93.6% to 121.1%. Conclusions Cefuroxime axetil suspension and Xilixin tablets are bioequivalent.