头孢地尼胶囊在健康人体的生物等效性研究

摘要

目的：评价健康人餐后服用两种头孢地尼胶囊的生物等效性。方法24例男性健康志愿者餐后随机交叉单剂量口服头孢地尼胶囊受试制剂或参比制剂，头孢地尼体内血药浓度采用液相色谱-质谱串联( LC-MS/MS)法测定，药动学参数及等效性采用药动学软件DAS计算和评价。结果受试制剂和参比制剂的主要药动学参数如下：AUCt分别为(4.35±1.09)和(4.12±1.22)μg��h��mL－1，AUC0-∞分别为(4.53±1.12)和(4.53±1.73)μg��h��mL－1，t1/2分别为(1.74±0.29)和(2.13±1.65) h，tmax分别为(4.44±0.86)和(4.54±1.16) h，Cmax分别为(900±250)和(876±269) ng��mL－1。结论头孢地尼胶囊受试制剂与参比制剂具有生物等效性。%Objective To evaluate postprandial pharmacokinetics and bioequivalence of two preparations of cefdinir capsules in Chinese healthy volunteers. Methods In a two-way cross-over study, 24 healthy male volunteers were divided into two groups randomly and a single dose of cefdinir capsules of test and reference preparation were administered orally, respectively.The concentration in plasma was determined by LC-MS/MS. Pharmacokinetic parameters and bioequivalence were calculated and evaluated by DAS. Results The main pharmacokinetic parameters of test and reference were as follows: AUCt (4.35±1.09) μg��h��mL-1 and (4.12±1.22) μg��h��mL-1, AUC0-∞(4.53±1.12) and (4.53±1.73) μg��h��mL-1, t1/2 (1.74±0.29) h and (2.13±1.65) h, tmax(4.44±0.86) h and (4.54 ±1.16) h, Cmax(900±250) ng��mL-1 and (876±269) ng��mL-1 . Conclusion The test and reference preparation of cefdinir capsules are bioequivalent.