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一种类凝血酶制剂的人体药动学研究
引用本文:沈文彧,邸伟庆,刘宏大,张竞超,牛惠生,李怀芬.一种类凝血酶制剂的人体药动学研究[J].中国医药导报,2011,8(10):59-61.
作者姓名:沈文彧  邸伟庆  刘宏大  张竞超  牛惠生  李怀芬
作者单位:1. 辽宁诺康生物制药有限责任公司,辽宁沈阳,110171
2. 中国医学科学院放射医学研究所,天津,300000
摘    要:目的:研究单次静注注射用尖吻蛇毒血凝酶(HCA)的人体药代动力学规律。方法:30例男性健康志愿者随机分组至1 U、2 U、4 U 3个剂量组,每组10例,采用放射免疫分析法对受试血清检测HCA的含量,用DAS软件计算其药代动力学参数。结果:受试者给药后,药-时曲线符合二室模型,主要药代动力学参数:t1/2α为34~55 min;t1/2β为301~351 min;CL分别为0.001 1、0.001 2、0.000 9 L/(min.kg),Vd分别为1.357 0、0.593 4、0.410 1 L/kg,AUC0-tn分别为16 518.38、22 405.67和29 531.41μU/(min.ml),呈明显的剂量依赖关系。结论:单次静注注射用HCA体内药代动力学特征符合一级线性动力学二室模型。

关 键 词:类凝血酶  药动学  放射免疫分析法

Pharmacokinetics of a thrombin-like enzyme injection in chinese healthy volunteers
SHEN Wenyu,DI Weiqing,LIU Hongda,ZHANG Jingchao,NIU Huisheng,LI Huaifen.Pharmacokinetics of a thrombin-like enzyme injection in chinese healthy volunteers[J].China Medical Herald,2011,8(10):59-61.
Authors:SHEN Wenyu  DI Weiqing  LIU Hongda  ZHANG Jingchao  NIU Huisheng  LI Huaifen
Institution:SHEN Wenyu1,DI Weiqing1,LIU Hongda1,ZHANG Jingchao1,NIU Huisheng2,LI Huaifen2 1.Liaoning Nuokang Biological pharmaceutical Limited Liability Company,Shenyang 110171,2.Chinese Academy of Medical Sciences Radiology Institute of Radiological Medicine Research,Tianjin 300000
Abstract:Objective:To study the pharmacokinetics of heamocoagulase agkistrodon(HCA) injection after a single dose in chinese healthy volunteers.Methods:30 male healthy volunteers were randomly allocated into three groups,receiving 1 U,2 U,4 U HCA injection,respectively.Every group had ten volunteers.The drug concentration in human serum were determined by radioimmunoassay method,and the pharmacokinetic parameters were calculated by DAS software.Results:The serum concentration-time curve fit the two-compartment model...
Keywords:Thrombin-like enzyme  Pharmacokinetics  Radioimmunoasssy  
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