METHOD OF QUANTIFYING NEUROTOXIN
    8.
    发明公开
    METHOD OF QUANTIFYING NEUROTOXIN 无效
    量化神经毒素的方法

    公开(公告)号:EP2015065A1

    公开(公告)日:2009-01-14

    申请号:EP06745899.2

    申请日:2006-04-28

    IPC分类号: G01N33/15 G01N33/50

    CPC分类号: G01N33/5088 G01N33/94

    摘要: The present invention relates to a method for quantitatively measuring the muscular relaxing activity of a neurotoxin. Specifically, based on an extent of the activity of muscular relaxation of a neurotoxin from bacteria of Clostridium , the present invention relates to a method for quantification of the efficacy (potential and/or diffusion reaction) of a neurotoxin comprising the following steps of: (a) administering a neurotoxin to the hind leg muscle of one of hind legs of a non-human mammal; (b) applying electric stimulus to said non-human mammal; (c) measuring a compound muscle action potential (CMAP) by contraction of said hind leg muscle to which the neurotoxin is administered and/or of the hind leg muscle of the other hind leg to which the neurotoxin is not administered; and (d) taking amplitude data from the compound muscle action potential (CMAP) obtained by the measurement in step (c) and analyzing an extent of a decrease in amplitude to thereby quantify the efficacy of the muscular relaxing activity by the neurotoxin. In contrast to the mouse LD 50 currently used as a potential unit of a botulinum toxin which is measurable at a level of only several units, the quantification method of the efficacy of a neurotoxin of the present invention allows for measurement at a level of as low as 0.01 to 1 unit and hence is a method with a high sensitivity, reproducibility and accuracy.

    摘要翻译: 本发明涉及定量测定神经毒素的肌肉松弛活性的方法。 具体而言,基于来自梭菌细菌的神经毒素的肌肉松弛活性的程度,本发明涉及定量神经毒素的功效(潜在和/或扩散反应)的方法,其包括以下步骤:( a)将神经毒素给予非人类哺乳动物后腿之一的后腿肌肉; (b)向所述非人类哺乳动物施加电刺激; (c)通过所述神经毒素给予的所述后腿肌肉和/或未给予所述神经毒素的另一后腿的后腿肌肉的收缩来测量复合肌肉动作电位(CMAP); (d)从通过步骤(c)中的测量获得的复合肌肉动作电位(CMAP)获取振幅数据并分析振幅降低的程度,从而量化神经毒素对肌肉放松活动的功效。 与目前用作肉毒毒素潜在单位的小鼠LD50相比,所述肉毒杆菌毒素可以以仅几个单位的水平测量,本发明神经毒素功效的定量方法允许测量的水平低至 0.01到1单位,因此是一种高灵敏度,重现性和准确性的方法。