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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 )。结论 经统计学证明两制剂有生物等效性
Objective To study the bioequivalence of domestic bambuterol tablets and imported tablets. Methods Twenty healthy volunteers were randomized to receive crossover study. The concentration of bambuterol metabolite terbutaline in plasma was determined by liquid chromatography / mass spectrometry. Results After data processing, the pharmacokinetics parameters of bambuterol after single oral administration of bambuterol and imported bambuterol: AUC0-t were (52 ± 2 1) μg · h · L-1 and ( 5 1 ± 20) μg · h · L-1, respectively, and the Tmax values were (29 ± 0) and 26 ± 0 (7) h and (60 ± 2 6) μg · L -1 And (6 2 ± 2 9) μg · L -1. Terbutaline: AUC0-t were (191 ± 30) μg · h · L-1 and (197 ± 37) μg · h · L-1, respectively. Tmax was (4 ± 10) h and 2 ± 1 0) h and Cmax were (10 ± 5) μg · L-1 and (10 ± 4) μg · L-1, respectively. The relative bioavailability of domestic bambuterol tablets after single administration was 102% ± 8% (bambuterol), 100% ± 12% (terbutaline). Conclusions The two formulations were statistically bioequivalent