摘要
10名健康志愿者随机交叉口服单剂量200mg广州产或进口尼美舒利(Nime)片后,采用高效液相色谱仪检测血浆中药物浓度.结果发现,广州、进口Nime在体内血药浓度时间曲线均符合一室模型.广州Nime主要药动学参数T_1/2Ke=3.61±1.43h,T_(peak)=2.07±0.63h,C_max=9.46±2.06mg·L^(-1),AUC=76.39±17.62mg·L^(-1)·h^(-1),其相对生物利用度为92.2%.广州与进口Nime的AUC经三因素方差分析和Bayesian方法分析,发现这两种制剂具有生物等效性.
The pharmacokinetics of domestic or imported nimesulide tablet was determined following a single oral dose of 200 mg given to 10 volunteers in randomized crossover study. The plasma concentration of nimesulide was assayed by HPLC method. The concentration -time curve of nimesulide conformed to a one-compartment model and the main parameters of domestic nimesulide were as follows: T1/2Ke 3. 61±1.43 h; Tpeak 2. 07±0. 63 h; Cmax=9. 46±2. 06 mg·L-1 ; AUC = 76. 39±17. 62 mg·L-1·h-1 respectively. The relative bioavailability of domestic tablet was 92.2%. The results of three factors analysis of variance and Bayesian method showed that two formulation were bioequiva-lent.
出处
《中国药理学通报》
CAS
CSCD
北大核心
1996年第2期185-186,共2页
Chinese Pharmacological Bulletin
