摘要
目的:评价国产与进口奥卡西平片剂的生物等效性。方法:18名健康男性受试者自身交叉单剂量口服国产或进口奥卡西平片300mg,以高效液相色谱-紫外(HPLC-UV)法测定血浆中奥卡西平浓度,用3p97软件计算主要药动学参数,以方差分析与单双侧t检验进行统计分析。结果:2种奥卡西平片剂的血浆中药动学参数分别为:t1/2(15.21±4.04)、(14.51±3.06)h,tmax(5.67±2.45)、(5.17±2.33)h,cmax(0.50±0.13)、(0.56±0.20)μg·mL-1,AUC0～48h(11.59±4.16)、(12.47±4.66)μg·h·mL-1。国产奥卡西平片的相对生物利用度为(94.81±14.21)%。结论:2种片剂在健康人体内具有生物等效性。
OBJECTIVE： To evaluate the bioequivalence of domestic and imported Oxcarbazepine tablets. METHODS： 18 healthy male volunteers were given single oral dose of domestic and imported Oxcarbazepine tablet 300 mg according to a random- ized crossover design. Plasma concentration of oxcarbazepine was detected by HPLC-UV. The pharmacokinetic parameters of oxcar- bazepine were calculated with 3p97 software. The bioequivalence was calculated by analysis of variance and two one side t-teat. RE- SULTS： The pharmacokinetic parameters of 2 kinds of Oxcarbazepine tablets were as follows： t1/2 （15.21±4.04）h vs. （14.51±3.06） h; tmax（5.67 ± 2.45）h vs.（5.17 ± 2.33）h;cmax（0.50 ± 0.13） μg·mL-1 vs.（0.56 ± 0.20）μg·mL-1;AUC0-48 h（11.59 ± 4.16）μg·h·mL-1 vs. （12.47 ± 4.66）μg·h·mL-1, respectively. The relative bioavailability of domestic Oxcarbazepine tablet was （94.81 ＋ 14.21）%. CON- CLUSION： 2 kinds of Oxcarbazepine tablets are bioequivalent in human body.
出处
《中国药房》
CAS
CSCD
2012年第42期3984-3986,共3页
China Pharmacy
