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目的:研究猕猴单次sc重组人胸腺肽α1(rh-Tα1)的药动学。方法:6只猕猴单次scrh-Tα1350μg/kg,采用酶联免疫分析检测(ELISA)法测定动物的血药浓度,实验数据用3P97药代软件拟合并计算药动学参数。结果:rh-Tα1在猕猴体内的消除符合一房室模型,6只动物的达峰时间(tmax)均为1.5h,平均消除半衰期(t1/2ke)为(2.9±0.8)h;峰浓度(Cmax)均值为(297.0±43.3)ng/mL;平均清除率(CL)为(0.373±0.116)mL/(h·kg);药时曲线下面积(AUC0～24h)均值为(1165±333)ng·h/mL。结论:血清样品经5倍稀释后用ELISA方法能较准确测定猕猴血清中rh-Tα1的量。6只猕猴scrh-Tα1后达峰时间一致且较短,主要药动学参数显示一定个体差异,但无明显性别差异。
Objective: To study the pharmacokinetics of rh-Tα1 single-stranded recombinant human thymosin α1. Methods: The blood samples were collected from 6 macaques with single scrh-Tα (1350 μg / kg). The plasma concentrations were determined by enzyme linked immunosorbent assay (ELISA). The pharmacokinetic parameters were calculated by 3P97 pharmacokinetic software. Results: The elimination of rh-Tα1 in rhesus monkeys was in accordance with one-compartment model. The peak time (tmax) and the half-life (t1 / 2ke) Cmax was (297.0 ± 43.3) ng / mL and the average clearance rate (CL) was (0.373 ± 0.116) mL / (h · kg) .The mean area under the curve (AUC0-24h) ng · h / mL. Conclusion: The serum samples can be more accurately determined by ELISA after 5-fold dilution of rh-Tα1 in cynomolgus monkey serum. The peak time of scrol-Tα1 was consistent and short after 6 macaques. The main pharmacokinetic parameters showed some individual differences but no significant gender differences.