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16例手术病人随机分两组,8例一次静脉推注20μg/kg进口芬太尼,另8例一次静脉推注20μg/kg国产芬太尼.用RIA法测定0-12 h的血药浓度和0-48 h的回收率.研究结果表明,芬太尼在病人体内的药代动力学模型为三室模型.芬太尼入血后血浆浓度下降迅速,10min时已有90%以上的入血药物被排除.药-时曲线显示,芬太尼在消除过程中血浆浓度有二次增加现象,主要是因为此药在人体存在肝肠循环.两组病人的T_(1/2π) .和T_(1/2α),T_(1/2)β分别为 2.00±1.24 min,27.56±43.09min,334.35=141.96min(比利时药组)和 1.59±0.64min,12.74±6.61min,301.61±70.15min(国产药组).Cls和Clr分别为1.18±0.33 l/min,0.07±0.03 l/min(比利时药组)和0.73±0.38 l/min,0.03±0.02 l/min.从结果看,两组主要药代动力学参数是相似的.注射芬太尼48h以内,尿中回收原型芬太尼占给药剂量的6.66±2.84%(比利时药组)和3.80±1.73%(国产药组).
Sixteen patients undergoing surgery were randomly divided into two groups: 8 patients received intravenous injection of 20μg / kg fentanyl and 8 patients received one intravenous infusion of 20μg / kg fentanyl respectively.RIA was used to determine plasma concentrations of 0-12 h And 0-48 h recovery rate.The results showed that the pharmacokinetic model of fentanyl in patients with three-compartment model.Fentanil plasma concentration dropped rapidly after 10min had more than 90% of the blood The drug was excluded.The drug-time curve showed that there was a second increase of plasma concentration of fentanyl in the elimination process, mainly because the drug exists in the human body enterohepatic circulation.Two groups of patients T_ (1 / 2π) and T_ 1 1/2 α) and T 1/2 (1/2) β were 2.00 ± 1.24 min, 27.56 ± 43.09min and 334.35 = 141.96min respectively (Belgian medicine group) and 1.59 ± 0.64min, 12.74 ± 6.61min and 301.61 ± 70.15min respectively Drug group) .Cls and Clr were 1.18 ± 0.33 l / min, 0.07 ± 0.03 l / min (Belgian drug group) and 0.73 ± 0.38 l / min, 0.03 ± 0.02 l / min.From the results, The pharmacokinetic parameters were similar within the first 48 hours after the injection of fentanyl, and the recovery of the prototype fentanyl in urine was 6.66 ± 2.84% (Belgian medicine group) and 3.80 ± 1.73% (Chinese medicine group).