聚合人血红蛋白类血液代用品中不溶微粒含量检定方法的研究

发布时间：2018-01-22 16:28

  本文关键词： 血红蛋白类携氧载体 血液代用品 不溶性微粒 光阻法 显微计数法　出处：《中国输血杂志》2015年12期 　论文类型：期刊论文

【摘要】：目的选取5批实验室自制的HBOCs制品溶液,考察其不溶性微粒的含量并比较不同检测方法检测结果的差异。方法按照《中国药典》(2010年版,三部)不溶性微粒规定的光阻法和显微计数法对HBOCs制品进行检测。结果实验选取的5批次HBOCs制品不溶性微粒检测结果均符合《中国药典》(2010年版)相关要求;光阻法检测结果明显高于显微计数法检测结果;HBOCs溶液不同梯度稀释后,显微计数法检测结果线性相关性分别为0.9095(10μm粒径)和0.8255(25μm粒径),而光阻法检测结果线性相关性分别为0.1967(10μm粒径范围)和0.0283(25μm粒径范围)。结论选取的HBOCs制品不溶性微粒含量质量总体情况较好;梯度稀释法显示,显微计数法检测HBOCs不溶性微粒结果具有较明显的线性相关性,而光阻法检测结果无明显线性关系,二者检测结果具有显著差异。
[Abstract]:Objective to select the 5 batch of homemade HBOCs product solution of the laboratory, study the differences of the content of insoluble particles and the detection method of comparison of different detection results. Methods according to the < > China Pharmacopoeia (2010 edition, three) the provisions of the insoluble particles in the light blockage method and microscopic counting method of HBOCs products were determined. Results a total of 5 batches of HBOCs products of insoluble particles test results are in line with China > < Pharmacopoeia (2010 Edition) the relevant requirements; light blockage detection results were significantly higher than the detection results of microscopic counting method; HBOCs solution of different gradient dilution after the detection results of microscopic counting method of linear correlation was 0.9095 (10 m diameter) and 0.8255 (25 m diameter), and the detection result by the light blockage of linear correlation was 0.1967 (10 m diameter range) and 0.0283 (25 m diameter range). Conclusion the selected HBOCs product insoluble particle content of the overall situation of better quality; gradient dilution method The results showed that there was a clear linear correlation between HBOCs and insoluble particles detected by microscopic counting. However, there was no significant linear relationship between the results of photoresist assay and the results of the two methods.

【作者单位】： 中国医学科学院北京协和医学院输血研究所;成都正康药业有限公司;天津协和生物科技发展研究所;
【基金】：国家高新技术产业计划(863)项目(2012AA021903-3) 四川省国际科技合作与交流研究计划(2014HH0065)
【分类号】：R927.2
【正文快照】： 2.成都正康药业有限公司;3.天津协和生物科技发展研究所)cle counter method;microscopy counting method;输血是临床治疗救助的重要途径,也是国家建立应急体系的重要组成部分。随着近年来临床用血需求量的逐年增大,血液供应紧张的局面日益加剧。另外,由于输注全血存在着免疫，

本文编号：1455169