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Standard Test Method for Evaluation of the Effect of Nanoparticulate Materials on the Formation of Mouse Granulocyte-Macrophage Colonies 纳米颗粒材料对小鼠粒细胞巨噬细胞集落形成的影响的标准测试方法
发布日期: 2008-02-01
1.1本试验方法提供了一种定量分析生理溶液中纳米颗粒材料对粒细胞-巨噬细胞集落形成单位影响的方案。 1.2本试验方法使用小鼠骨髓造血干细胞,其增殖和分化形成离散的细胞簇或菌落,并进行计数。 1.3本试验方法是用于医疗应用中全身给药的纳米颗粒材料体外临床前表征级联的一部分。 1.4 本标准并非旨在解决与其使用相关的所有安全问题(如有)。本标准的用户有责任在使用前制定适当的安全和健康实践,并确定监管限制的适用性。 ====意义和用途====== 造血来源的干细胞具有多潜能,可能对纳米颗粒材料的刺激作用特别敏感。 颗粒对巨噬细胞反应的影响有着广泛的历史,可以通过1903年的实践进行评估 . 这里描述的测试方法将评估对干细胞的影响,干细胞可以是巨噬细胞系的祖细胞。
1.1 This test method provides a protocol for quantitative analysis of the effect of nanoparticulate materials in physiologic solution on granulocyte-macrophage colony-forming units. 1.2 This test method employs murine bone marrow hematopoietic stem cells which proliferate and differentiate to form discrete cell clusters or colonies which are counted. 1.3 This test method is part of the in vitro preclinical characterization cascade for nanoparticulate materials for systemic administration in medical applications. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. ====== Significance And Use ====== Stem cells of hematopoietic origin are pluripotential and may be particularly sensitive to the effects of stimulation by nanoparticulate materials. The effect of particles on macrophage responses has an extensive history and can be assessed by Practice F 1903 . The test method described here will assess the effect on stem cells which can be progenitor cells to the macrophage line.
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归口单位: E56.03
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