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为了观察冻干粉针剂和水针剂的人体药代动力学，将１０位健康志愿者，随机分成Ａ，Ｂ二组，交叉肌注冻干粉针剂和水针剂干扰素，用ＷＩＳＨ细胞和ＶＳＶ系统生物学方法测定血干扰素效价浓度，用３Ｐ８７计算机软件计算药代动力学参数，结果为二种剂形的时间－干扰素效价浓度基本相似。Ｔ１／２ａ分别为０．９４±０．５和１．３３±０．５９ｈ，Ｔ１／２ｋｅ分别为９．８±２．３和９．７±２．３ｈ，Ｔｍａｘ分别为６．７０±０．６５和６．４７±１．０５ｈ，Ｃｍａｘ分别为４９．９±１１．５和４９．４±１２．１ＩＵ·ｍｌ－１，ＡＵＣ分别为６６８．０±１３２．９和６６３．０±１３５．６ＩＵ·ｈ·ｍｌ－１，经统计学处理，无显著性差异（Ｐ＞０．０５），按双向单侧Ｔ检验和等效界值法计算，显示二者具有生物等效性
In order to observe the pharmacokinetics of lyophilized powder injection and water injection, 10 healthy volunteers were randomly divided into groups A and B, crossover muscle injection of lyophilized powder and water injection of interferon, WISH cells and VSV system The biological method was used to determine the potency of interferon. The pharmacokinetic parameters were calculated by 3P87 computer software. The results showed that the time-interferon titer of the two formulations were similar. T1 / 2a were 0.94 ± 0.5 and 1.33 ± 0.59h, T1 / 2ke were 9.8 ± 2.3 and 9.7 ± 2.3h, Tmax were 6.70 ± 0 .65 and 6.47 ± 1.05 h, Cmax were 49.9 ± 11.5 and 49.4 ± 12.1 IU · ml-1 respectively, AUC was 668.0 ± 132.9 and 663.0 ± 135 .6IU · h · ml-1, after statistical treatment, no significant difference (P> 0.05), according to two-way unilateral T-test and equivalent cut-off method calculated, both showed bioequivalence