论文部分内容阅读
目的:研究克拉霉素片在健康人体内的药动学与相对生物利用度。方法:采用高效液相色谱法测定8名志愿者单剂量po500mg不同厂家产克拉霉素片后的血药浓度变化情况,计算两者的药动学参数及相对生物利用度,以AUC0∞,tmax,cmax为指标,配对t检验法分析两厂产克拉霉素片的生物等效性。结果:二者药时曲线可用二室模型拟合,其:t1/2(β)分别是3.04h和3.91h,tmax分别是1.94h和1.92h,cmax分别是2.34μg·ml-1和2.27μg·ml-1,AUC0∞分别是13.66μg·h·ml-1和14.44μg·h·ml-1。配对t检验结果表明,两厂产品的AUC0∞,cmax,tmax均无显著性差异(P>0.05)。结果:两厂家产克拉霉素片为生物等效制剂,A药对B药的相对生物利用度为95.3%。
Objective: To study the pharmacokinetics and relative bioavailability of clarithromycin tablets in healthy volunteers. Methods: The change of plasma concentration of single-dose po 500mg clarithromycin tablets from 8 different volunteers in 8 volunteers was determined by HPLC. The pharmacokinetic parameters and relative bioavailability of the two drugs were calculated. The AUC0∞, tmax, cmax as indicators, paired t test analysis of the bio-equivalence of clarithromycin tablets produced by the two plants. Results: The two curves were fitted by two-compartment model: t1 / 2 (β) were 3.04h and 3.91h respectively, tmax was 1.94h and 1.92h respectively, cmax was 2.34μg · Ml-1 and 2.27 μg · ml-1 respectively, and AUC0∞ were 13.66 μg · h · ml-1 and 14.44 μg · h · ml-1, respectively. Paired t-test showed that there was no significant difference in AUC0∞, cmax, tmax between the two plants (P> 0.05). Results: The clarithromycin tablets produced by two factories were bioequivalent. The relative bioavailability of drug A to drug B was 95.3%.