JCLA：应用电化学发光法定量测定抗分形多胺单克隆抗体E6011在猴子和人类体内的药代动力学研究

2019-05-16 不详网络

E6011是一种人源抗fractalkine单克隆抗体，目前正用于治疗各种炎症性疾病，如类风湿关节炎。本研究建立了用电化学发光(ECL)法测定猴血清和人血清中E6011的方法。 mso-ascii-theme-font:minor-latin;mso-fareast-font-family:宋体;mso-fareast-theme-font: minor-fareast;mso-hansi-f

E6011是一种人源抗fractalkine单克隆抗体，目前正用于治疗各种炎症性疾病，如类风湿关节炎。本研究建立了用电化学发光(ECL)法测定猴血清和人血清中E6011的方法。

研究人员用fractalkine检测血清中的E6011，用钌标记的兔抗E6011 Fab多克隆抗体检测ECL。E6011血清中从0.02和0.1可量化μg /毫升的猴子和人类的血清，最低稀释量为500。然后根据生物分析指南对该方法进行了验证。

五种浓度的质量控制样品在a‐中的准确度和精密度以及批次间重现性表明，相对误差和相对标准偏差在可接受的标准范围内。在人类和猴子中，E6011的回收率分别为92.9%‐121.7%和85.0%‐109.3%。稀释完整性、无前体效应、无抗原影响。平行度也被证实使用发生的临床样本分析。对各类型稳定性进行了评价，结果表明，在冷冻条件下，E6011在猴血清中稳定367天，在人血清中可稳定735天。

研究表明，该方法已成功应用于猴子和人类的药代动力学研究。

原始出处：

Muneo Aoyama, Yuji Mano,Application of an electrochemiluminescence assay for quantification of E6011, an antifractalkine monoclonal antibody, to pharmacokinetic studies in monkeys and humans

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2020-03-31 ms1948154235210413

#猴子#

36 0
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2019-08-24 爆笑小医

#测定#

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2019-08-07 kksonne

#电化学#

41 0
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2020-04-18 waiwai3043

#多胺#

31 0
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2019-09-18 fengyqf

#药代#

23 0
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2019-09-25 aids221

#克隆#

23 0
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2019-05-18 zhaojie88

#药代动力学#

30 0

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