BIOEQUIVALENCE OF BAMBUTERAL AND ITS METABOLITES TERBUTALINE AFTER ORAL BAMBUTERAL TABLET IN HEALTHY VOLUNTEERS BY HPLC/MS
- VernacularTitle:HPLC/MS研究国产盐酸班布特罗片及其代谢物特布他林人体生物等效性
- Author:
Chunhua SUN
;
Lei LIU
;
Qi YIN
- Publication Type:Journal Article
- From:
Acta Pharmaceutica Sinica
2001;36(5):368-372
- CountryChina
- Language:Chinese
-
Abstract:
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: AUC0-t were (52±21) μg*h*L-1 and (51±20) μg*h*L-1, Tmax were (2.9±0.9) h and (2.6±0.7) h, Cmax were (6.0±2.6) μg*L-1 and (6.2±2.9) μg*L-1, T1/2Ke were (11.2±2.3) h and (11.2±1.9) h, respectively; terbutaline: AUC0-t were (191±30) μg*h*L-1 and (197±37) μg*h*L-1; Tmax were (4.2±1.0) h and (4.2±1.0) h; Cmax were (10±5) μg*L-1 and (10±4) μg*L-1; T1/2Ke 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.
