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目的研究中国健康成年志愿者单剂静脉注射尖吻蝮蛇血凝酶的药代动力学。方法将30名健康受试者随机分成3组,每组10名,男女各半,分别单剂静脉注射尖吻蝮蛇血凝酶4,5,6U后,用放射免疫法(RIA)测定体内血药浓度,用3P97软件进行数据处理,求出药代动力学参数。结果药-时曲线符合二房室模型,主要药代动力学参数C0分别为(1.09±0.14),(1.46±0.02),(1.76±0.01)μg·L-1;t1/2β分别为(2.56±0.30),(2.44±0.35),(2.63±0.40)h;AUC0~t分别为(2.21±0.15),(2.59±0.16),(3.15±0.26)μg·h·L-1;Vd分别为(10.36±1.13),(8.77±0.78),(8.16±2.24)L;CL分别为(4.53±0.44),(4.94±0.36),(5.06±0.52)L·h-1。结论尖吻蝮蛇血凝酶在4~6U内,药物体内过程呈一级线性动力学特征而无饱和性。
Objective To study the pharmacokinetics of single-dose intravenous injection of Serratia sinica in healthy volunteers in China. Methods Thirty healthy subjects were divided into three groups at random, 10 in each group. The men and women were divided into two groups. After a single intravenous injection of 4, 5 and 6 U of Coke venom Serum Coagulase Coagulase, they were determined by radioimmunoassay (RIA) Blood concentration, using 3P97 software for data processing, find the pharmacokinetic parameters. Results The drug-time curve was in accordance with the two-compartment model. The main pharmacokinetic parameters C0 were (1.09 ± 0.14), (1.46 ± 0.02) and (1.76 ± 0.01) μg · L-1, (2.21 ± 0.15), (2.59 ± 0.16) and (3.15 ± 0.26) μg · h · L-1, respectively; Vd was (2.63 ± 0.40) 10.36 ± 1.13), (8.77 ± 0.78) and (8.16 ± 2.24) L, respectively; CL were 4.53 ± 0.44, 4.94 ± 0.36 and 5.06 ± 0.52 L · h-1, respectively. Conclusions In Agkistrodon halysii serogroup 4 ~ 6U, the process of drug in vivo showed a first-order linear kinetic characteristic without saturation.