头孢丙烯颗粒人体药动学和相对生物利用度研究

目的：研究头孢丙烯颗粒在健康人体内的药动学和相对生物利用度，并与市售头孢丙烯片进行生物等效性评价。方法：18名男性健康受试者双周期随机交叉单剂量口服500mg头孢丙烯颗粒剂和片剂，两次试验间隔为1周，采用HPLC法测定血浆中头孢丙烯的浓度。结果：受试制剂与参比制剂的体内过程基本一致，其主要药动学参数Cmax分别为（10．36±1．27）和（8．90±0．93）μg／mL；tmax分别为（1．07±O．30）和（2．19±0．81）h；t1/2分别为（1.55±0．17）和（1．47±0．22）h；AUC0-10分别为（31．39±5．17）和（30．21±4．77）μg·h·mL^-1。结论：统计分析结果表明两种制剂具有生物等效性，头孢丙烯颗粒的相对生物利用度为（104．30±9．94）％。

Pharmacokinetics and relative bioavailability of cefprozil granules in healthy volunteers

Objective：To evaluate the pharmacokinetics and relative bioavailability of cefprozil granules in healthy volunteers. Methods： Eighteen heahhy male volunteers were randomized into two groups. A single oral dose of 500 mg cefprozil granules（test） or tablets（reference） were given respectively to the volunteers according to a randomized two-way cross-over study design. The washout period was one week. The plasma concentrations of cefprozil were determined by HPLC method. Results： The process in vivo of the test and reference preparations were essentially identical. The main pharmaeokinetic parameters of the test and reference preparations were as follows：cmax（10. 36±1. 27） and （8. 90±0. 93） μg/mL,tmax （1.07±0.30） and （2.19±0.81） h,t1/2（1.55±0.17） and （1.47±0.22） h, AUC0-10（31.39±5. 17）and （30.21±4.77） μg · h · mL^- 1 , respectively. Conclusion：The results of statistical analysis show that two preparations are of bioequivalence. The relative bioavailability of cefprozil granules is （104.30±9.94）%.