摘要
目的 研究国产班布特罗片剂和进口片剂进行人体生物等效性研究。方法 2 0名健康受试者随机交叉给药 ,用液相色谱 /质谱联用测定血浆中班布特罗其代谢物特布他林的浓度。结果 经数据处理 ,单次口服国产和进口班布特罗片剂后班布特罗的药代动力学参数 :AUC0 -t分别为 (5 2± 2 1) μg·h·L-1和 (5 1± 2 0 ) μg·h·L-1,Tmax分别为 (2 9± 0 9)h和 (2 6± 0 7)h ,Cmax分别为 (6 0± 2 6 ) μg·L-1和 (6 2± 2 9) μg·L-1。特布他林 :AUC0 -t分别为 (191± 30 ) μg·h·L-1和 (197± 37) μg·h·L-1,Tmax分别为 (4 2± 1 0 )h和 (4 2± 1 0 )h ,Cmax分别为 (10± 5 )μg·L-1和 (10± 4) μg·L-1。国产班布特罗片剂单次给药后的相对生物利用度为 10 2 %± 8% (班布特罗 ) ,10 0 %±12 % (特布他林 )。
AIM To study bioequivalence of bambuteral and its metablites terbutaline in 20 healthy male volunteers. METHODS A single oral dose of domestic or imported bambuteral tablet was given according to a randomized 2 way cross over design. The plasma bambuteral and terbutaline concentrations were determined by HPLC/MS. RESULTS The pharmacokinetic parametrs of domestic and imported bambuteral: AUC 0-t were (52±21) μg·h·L -1 and (51±20) μg·h·L -1 , T max were (2 9±0 9) h and (2 6±0 7) h, C max were (6 0±2 6) μg·L -1 and (6 2±2 9) μg·L -1 , T 1/2 K e were (11 2±2 3) h and (11 2±1 9) h, respectively; terbutaline: AUC 0-t were (191±30) μg·h·L -1 and (197±37) μg·h·L -1 ; T max were (4 2±1 0) h and (4 2±1 0) h; C max were (10±5) μg·L -1 and (10±4) μg·L -1 ; T 1/2 K e were (20±3) h and (21±4) h, respectively. The bioavaiability of the domestics was 102%±8% (bambuteral) and 100%±12% (terbutaline). CONCLUSION The results demonstrate that the two forms of bambuteral and terbutaline were bioequivalent by analysis of variance, two one sided test and 90% confidential limit.
出处
《药学学报》
CAS
CSCD
北大核心
2001年第5期368-372,共5页
Acta Pharmaceutica Sinica
