头孢克洛干混悬剂在健康志愿者体内的生物等效性

Bioequivalence of cefaclor suspension in healthy volunteers

目的:评价头孢克洛干混悬剂在20名男性健康志愿者体内的生物等效性。方法:20名健康志愿者分两组,随机、交叉口服单剂量受试和参比制剂头孢克洛干混悬剂750 mg。采用高效液相色谱法测定血浆中头孢克洛浓度。用DAS软件进行药动学参数计算及生物等效性评价。结果:头孢克洛干混悬剂受试与参比制剂的t_(1/2)分别为(1.519±0.807)和(1.631±0.808)h;C_(max)分别为(5.858±1.614)和(5.850±1.715)μg·mL^(-1);T_(max)分别为(0.516±0.138)和(0.546±0.155)h;AUC_(0-6)分别为(7.184±1.919)和(7.133±1.758)μg·h·mL^(-1)。以AUC_(0～6)计算试验制剂的相对生物利用度为(101.4±15.3)%。结论:两种头孢克洛制剂生物等效。

Objective：To study the bioequivalence of the test and reference cefaclor suspensions-in 20 male healthy volunteers.Methods：Single oral doses（750 mg）of two cefaclor suspensions were given to 20 healthy volunteers in a randomized cross-over study.The concentration of cefaclor in plasma was determined by HPLC.Resuits：For the test and reference cefaclor suspensions,t1/2 were （1.519±0.807）and（1.631±0.808）h;Cmax were（5.858±1.614）and（5.850±1.715）μg·mL^-1;Tmax were（0.516±0.138）and （0.546±0.155）h; AUC（0-t） were （7.184±1.919） and （7.133±1.758）μg·h·mL^-1.The relative bioavailability of AU（C0～6）was （101.4±15.3）%.Conclusion：Two preparations of cefaclor suspension were bioequivalent in health volunteers as confirmed by statistical analysis.