摘要
目的研究秋水仙碱片(痛风性关节炎药)在健康人体的相对生物利用度和生物等效性。方法健康志愿者18名,用随机双交叉试验方法,单剂量po受试及参比制剂1mg,剂间隔为2周。用液质联用法测定血浆中秋水仙碱浓度,计算2者的药代动力学参数及相对生物利用度,并进行生物等效性评价。结果单剂量po试验及参比制剂的Cmax分别为(6.38±2.75),(6.63±3.12)μg.L-1;tmax分别为(1.7±1.3),(1.5±0.7)h;t1/2分别为(17.28±5.59),(15.78±2.58)h;AUC0-48分别为(50.19±14.93),(48.22±16.23)μg.h.L-1,AUC0-inf分别为(57.70±15.91),(54.24±18.12)μg.h.L-1;以AUC0-t计算,受试制剂的相对生物利用度为(110.3±39.1)%。结论2制剂在单剂量下具有生物等效性。
Objective To study the bioequivalence and relative bio- availability of colchicine tablets in healthy volunteers. Methods A single oral dose（2 mg of test or reference）were given to 18 healthy volunteers in a randomized cross - over study. The concentrations of colchicines in plasma were determined by LC/MS/MS method. The pharmacokinetic parameters were calculated and the bioavailability and bioequivalence of two formulations were evaluated. Results After a single dose , the pharmacokinetic parameters for colchicines were as follows ： Cmax were （6.38 ±2.75） and （6.63 ±3.12）μg·L^-1：;tmax were （1.7 ±1.3） and （1.5 ±0. 7 ） h; t1/2 were （ 17.28 ±5.59） and （ 15.78 ± 2.58 ） h; AUC0.as were （50.19 ± 14.93 ） and （48.22 ± 16.23 ） μg·h·L^-1, AUC0-inf were （57.70±15.91） and （54.24 ±18.12）μg·h·L^-1 for tested and reference formulations, respectively. The relative bioavailability was （ 110.3 ± 39.1 ） %. Conclusion The results showed that the two formulations were bioequivalence.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2007年第4期284-287,共4页
The Chinese Journal of Clinical Pharmacology
