重组人α-2a干扰素正常人体的药动学  

Pharmacokinetics of recombinant human interferon α 2a in healthy volunteers

作　　者：朱振峰[1] 刘风芝[1] 杨秦予[1] 马统勋[1] 熊诗松[2] 赵敏[2] 刘欣[2] 

机构地区：[1]河南医科大学临床药理教研室 [2]河南省医学科学研究所

出　　处：《中国抗生素杂志》1999年第1期58-59,80,共3页Chinese Journal of Antibiotics

摘　　要：分别给８例健康志愿者肌注重组人α－２ａ干扰素（ｒＨＩＦＮα－２ａ）３×１０６Ｕ，以ＷＩＳＨ／ＶＳＶ系统细胞病变抑制法测血清中ｒＨＩＦＮα－２ａ浓度，用ＭＣＰＫＰ软件处理药－时数据。结果证明，８例中分别有７例和１例肌注该药符合一房室和二房室模型，８例的平均血清浓度－时间数据亦符合一房室模型。主要药动学参数如ＴＰ、Ｔ１／２、Ｃｍａｘ、ＡＵＣ分别为４．９３ｈ、５．３９ｈ、５５．５７Ｕ／ｍｌ、７５８．１４Ｕｈ／ｍｌ，２４ｈ的实测和计算浓度分别为７．８８和７．２６Ｕ／ｍｌ。提示临床应用一日给药１次即可。The pharmacokinetic study of recombinant human interferon α 2a (rHIFN α 2a) was carried out in 8 healthy volunteers. Each volunteer was given a single dose of 3×10 6U of the drug by im. The serum concentration of the drug was assayed by Cell Alteratic Inhibition Method with the WISH/VSV system. The concentration-time data of the drug were disposed with MCPKP software. Results demonstrated that the data of 7 out of 8 volunteers were in line with one compartment open model, and one volunteer′s data was in line with two compartments open model. The data of the mean serum concentration-time of the 8 volunteers were also in line with one compartment open model. The pharmacokinetic parameters such as T p, T 1/2 , C max , and AUC were 4.93h, 5.39h, 55.57 U/ml, and 758.14 U·h/ml, respectively. The assayed and the caculated concentration at the 24h after administration by im were 7.88 and 7.26 U/ml. According to the above results, clinical administration of the drug once a day was enough.

关 键 词：重组人α-2a干部素 正常人体 药代动力学 

分 类 号：R978.7[医药卫生—药品]