重组人血小板生成因子_

重组人血小板生成因子注射液的I期临床药代动力学

http://www.100md.com 《第四军医大学学报》 2005年第15期

重组人血小板生成因子,,重组人血小板生成因子；ELISA；药代动力学,0引言,1材料和方法,2结果,3讨论,【参考文献】

     Phase I clinical pharmacokinetics of recombinant human thrombopoietin in healthy volunteers

    SHEN Tong，WEN AiDong，ZHAO Lei，CHEN PingJun， WANG Meng，BAI QingXian，WANG WenQing，MA ZhongYing

    1Department of Pharmacy，2Department of Hematology，Xijing Hospital，Fourth Military Medical University，Xi’an 710033，China

    【Abstract】 AIM：To study the pharmacokinetics after a single subcutaneous injection of Chinamade recombinant human thrombopoietin(rhTPO, a product of Zhongxinguojian Pharmaceutical Co Ltd)in healthy volunteers. METHODS: Twentyseven healthy volunteers were randomized to 3 groups. The volunteers in the 3 groups received a single injection of rhTPO in a dosage of 0.5, 1.0 and 2.0 μg/kg respectively. Blood samples were collected serially before and after the medication. The rhTPO concentrations in serum were determined by ELISA. RESULTS: The pharmacokinetic parameters obtained were: T1/2ke occurred at (46.74±6.36), (48.53±2.29) and (51.88±3.34) h; T1/2ka were (2.17±0.53), (2.64±0.53) and (2.84±0.62) h; Tpeak were (10.00±1.51), (10.22±1.20) and (10.00±1.00) h; ρmax were (312.29±61.65), (465.14±46.94) and (811.34±106.73) ng/L; AUC(0-216 h) were (17 269.92±4470.23), (29 710.56±3890.28) and (53 358.41±5608.01) ng/L·h. CONCLUSION: When administrated subcutaneously in human within the dosage of 0.5-2. 0 μg/kg, rhTPO has the characteristics of linear pharmacokinetics, with longer halflife elimination. For clinical application in phase II trial, the recommended daily dosage is 1.0 μg/kg, subcutaneous injection for 7 d. ......

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