摘要
目的考察头孢地尼分散片的健康人体相对生物利用度,并进行生物等效性评价。方法采用随机交叉试验设计,20例男性健康志愿者分别单剂量口服受试制剂与参比制剂各100 mg。采用高效液相色谱紫外法测定血浆头孢地尼浓度,用DAS 2.0统计软件计算药动学参数并进行生物等效性评价。结果受试制剂与参比制剂Cmax分别为(0.920±0.236)和(0.907±0.216)μg.mL-1,tmax分别为(3.375±0.944)和(3.625±0.825)h;t1/2分别为(1.826±0.600)和(1.910±0.597)h;AUC0-10分别为(4.305±1.080)和(4.392±1.224)μg.h.mL-1,AUC0-∞分别为(4.632±1.147)和(4.803±1.325)μg.h.mL-1;受试制剂相对于参比制剂的生物利用度为(101.0±23.2)%。结论两制剂具有生物等效性。
Objective To study the relative bioavailability and bioequivalence of cefdinir dispersible tablet in healthy volunteers. Methods In a randomized crossover study, 20 healthy male volunteers were given a single oral dose of 100 mg test and reference dispersible tablet. A reversed - phase high performance liquid chromatography was employed for determining cefdinir in plasma, for which pharmacokinetic parameters were calculated and the relative bioavailability of two formulations was evaluated by using DAS 2.0 software. Results The main pharmacokinetic parameters of the test and reference dispersible tablets were as follow： C were （0. 920 ± 0. 236） and （0. 907 ± 0. 216） μg·mL^-1 ; tmax were （3. 375 ± 0. 944） and （3.625±0.825） h; t1/2were （1.826±0.600） and （1.910±0.597） h; AUC0-10 were （4.305 ±1.080） and （4.392± 1. 224） μg·h·mL^-1 ; AUC0-∞ were （4. 632 ± 1. 147） and （4. 803 ± 1. 325） μg·h·mL^-1 ; The relative bioavailability of the test preparation was （101.0 ± 23.2）%. Conclusion The test and reference dispersible tablets were bioequivalent.
出处
《医药导报》
CAS
2009年第2期168-170,共3页
Herald of Medicine
