头孢泊肟酯干混悬剂在健康志愿者中的生物等效性  

The bioequivalence of cefpodoxime oral suspension in healthy volunteers

作　　者：曾桂雄[1] 黄民[1] 钟国平[1] 王雪丁[1] 凌泳涛 黄丽慧[3] 

机构地区：[1]广州中山大学临床药理研究所,510080 [2]广州南新制药有限公司 [3]广州,中山大学临床药理研究所510080

出　　处：《中国抗感染化疗杂志》2003年第3期149-151,共3页Chinese Journal of Infection and Chemotherapy

摘　　要：目的:研究头孢泊肟酯干混悬剂在健康人体内的药代动力学及生物等效性。方法:20名受试者随机交叉分别服用头孢泊肟酯干混悬剂(受试制剂)或头孢泊肟酯片剂(参比制剂)各200mg,用微生物法测定人体血浆药物浓度。结果:受试干混悬剂、参比片剂的t_(max)分别为(2.8±0.5)h和(3.1±0.5)h,C_(max)分别为(2.85±0.55)和(2.55±0.62)mg/L。t_(1/2)分别为(2.2±0.2)和(2.3±0.3)h,AUC_(0-t)分别为(16.56±3.96)和(14.79±3.77)mg·h·L^(-1)。受试干混悬剂相对于参比片剂的生物利用度为(115.0±27.1)％。结论:经生物等效性检验,受试干混悬剂与参比片剂具生物等效性。Objective: To study the bioequivalence of cefpodoxime oral suspensions in healthy volunteers. Methods: Twenty normal volunteers were enrolled in a randomized crossover study. Each volunteer was given a single oral dose of 200 mg cefpodoxime suspension (test preparation) or cefpodoxime tablet (reference preparation) for comparison. The plasma concentrations of cefpodoxime were determined by microbiologic assay. Results: The pharmacokinetic parameters of cefpodoxime suspension and cefpodoxime tablet were: tmax(2.8±0.5) and (3.1 ±0.5) h respectively; Cmax(2.85±0.55) and (2. 55±0.62) mg/L, t1/2 (2.2±0.2) and (2. 3±0.3) h; AUC0-t(16. 56±3.96) and (14.79±3.77) mg·h·L-1. The relative bioavailability of cefpodoxime oral suspension was 115.0% ± 27.1% . Conclusions: Cefpodoxime suspensions and cefpodoxime tablet are bioequivalent.

关 键 词：头孢泊肟酯干混悬剂 健康志愿者 生物等效性 药代动力学 

分 类 号：R96[医药卫生—药理学]