摘要
目的:研究国产盐酸托烷司琼胶囊与进口注射液口服给药后的人体相对生物利用度。方法:采用两制剂双周期交叉试验设计,22名健康男性受试者分别口服单剂量国产胶囊与进口注射液5mg,采用高效液相色谱-质谱法测定人血浆中托烷司琼的浓度。结果:国产胶囊与进口注射液的主要药动学参数:Cmax分别为(7.3±2.5)和(7.5±2.5)μg.L-1,tmax分别为(3.4±1.1)和(3.3±1.4)h,AUC0-48h分别为(114.7±72.1)和(113.2±71.2)μg.L-1.h。两种剂型的主要药动学参数间差异均无显著性(P>0.05);经双单侧t检验,两制剂具有生物等效性。国产胶囊剂的相对生物利用度为(102.3±18.7)%。结论:国产胶囊与进口注射液口服给药生物等效。
OBJECTIVE To study the pharmacokinetics and relative bioavailability of tropisetron hydrochloride domestic capsule and imported injection in heahhy volunteers. METHODS in a randomized crossover study, single oral doses of 5 mg tropisetron hydrochloride capsule or injection were given to 22 healthy male volunteers. Tropisetron in plasma was determined by a validated I.C MS assay. RESULTS The parameters of the two formulations for tropisetron were as follows：Cmax were（7. 3 ± 2. 5）and（7.5±2. 5）μg·L^-1 , tmax were（3.4±1.1）and（3.3±1.4）h, AUC0-48h, were（114. 7±72. 1）and（113.2±71.2）μg·L^-1,h, respectively. The relative bioavailability of domestic capsule was （ 102.3 ± 18. 7）%. The statistical analysis results of the a hove parameters showed that there was no significant difference between the two formulations. CONCLUSION The two formulations are bioequivalence when adninistered orally.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2006年第5期563-565,共3页
Chinese Journal of Hospital Pharmacy
