蔡永明,陈拯民,孙超渊,刘昌孝.酶联免疫法研究注射用重组人胸腺肽α1的猕猴药动学[J].药物评价研究,2009,32(2):88-91
酶联免疫法研究注射用重组人胸腺肽α1的猕猴药动学
Pharmacokinetics of rh-Tα1 for injection in monkeys by enzyme-linked immunosorbent assay
投稿时间:2009-05-09  
DOI:10.7501/j.issn.0253-6376.[year].[issue].[sequence]
中文关键词:  重组人胸腺肽α1(rh-Tα1);ELISA;药动学
英文关键词:recombinant human Thymosin α1(rh-Tα1); enzyme-linked immunosorbent assay (ELISA); pharmacokinetics
基金项目:国家高技术研究发展计划(No.2007BAI14IB04),国家重点基础研究发展计划(No.2004CB518902)
作者单位
蔡永明1,2,陈拯民1,孙超渊1,刘昌孝1 1 天津药物研究院 天津药代动力学与药效动力学省部共建国家重点实验室,天津 300193 2 天津大学化工学院 制药工程专业,天津 300072 
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中文摘要:
      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sc rh-Tα1 350 μg/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1.5 h,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(1 165±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sc rh-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。
英文摘要:
      Objective: To explore pharmacokinetic properties of a recombinant human Thymosin α1 (rh-Tα1) followingsc administration in monkeys. Methods: The monkeys received single sc doses of rh-Tα1 at 350 μg/kg. Serum concentration of rh-Tα1 was measured at various time-points after dosing by an enzyme-linked immunosorbent assay (ELISA). Pharmacokinetic parameters were calculated with 3P97 software. Results: The concentration-time profile of rh-Tα1 in monkeys was described by an one-compartment model. The mean time to reach peak concentration (tmax) was 1.5 h. The mean elimination half-life (t1/2ke) was (2.9 ± 0.8) h. The average clearance rate was (0.373 ± 0.116) mL/(h·kg). The mean peak concentration (Cmax) was (297.0 ± 43.3)ng/mL. The mean area under the serum concentration-time curve (AUC0~24 h) was (1 165 ± 333) ng·h/mL. Conclusion: Serum concentration of rh-Tα1 is detected accurately by ELISA method when serum samples are diluted five times. The tmax of the six monkeys are the same, but the main pharmacokinetic parameters demonstrate a certain degree of individual differences without obvious sex differences.
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