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CN107686858A 确定质粒药物是否具有生物活性的方法、装置及其应用 无效 - 驳回 转让

确定质粒药物是否具有生物活性的方法、装置及其应用
摘要：
本发明提出了确定质粒药物生物活性的方法和装置，所述质粒药物表达HGF，该方法包括：(1)将待测质粒药物引入哺乳动物细胞中，所述待测质粒携带表达HGF的核酸分子；(2)在适于HGF表达的条件下，对步骤(1)中所得到的所述哺乳动物细胞进行培养，并收集培养物的上清液；(3)使步骤(2)中所得到的上清液与HUVEC细胞接触，并确定在所述接触前后，所述HUVEC细胞的增殖活性变化；以及(4)基于所述HUVEC细胞的增殖活性变化，确定所述待测质粒药物是否具有生物活性，其中，在所述接触后，所述HUVEC细胞的增殖活性得到显著提高是所述待测质粒药物具有生物活性的指示。上述方法能够客观、准确、可重复性高地确定表达HGF质粒药物的生物活性。
摘要（英）：

The invention provides a method and device of determining bioactivity of a plasmid medicine. The plasmid medicine expresses HGF; the method comprises the following steps: (1) introducing a to-be-tested plasmid medicine into a mammalian cell, wherein the to-be-tested plasmid carries a nucleic acid molecule expressing HGF; (2) in a condition suitable for HGF expression, culturing the mammalian cellobtained in the step (1), and collecting the supernate of the culture; (3) enabling the supernate obtained in the step (2) to touch HUVEC cell, and determining the change of proliferation activity ofthe HUVEC cell before and after the touch; (4) determining whether the to-be-tested plasmid medicine has bioactivity based on the change of proliferation activity of the HUVEC cell, wherein a remarkable increase of the proliferation activity of the HUVEC cell after the touch indicates that the to-be-tested plasmid medicine has bioactivity. The method can be used for objectively and accurately determining the bioactivity of the HGF plasmid medicine, with high repeatability.

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