本文關(guān)鍵詞： 血紅蛋白類攜氧載體 血液代用品 不溶性微粒 光阻法 顯微計數(shù)法　出處：《中國輸血雜志》2015年12期 　論文類型：期刊論文

【摘要】：目的選取5批實驗室自制的HBOCs制品溶液,考察其不溶性微粒的含量并比較不同檢測方法檢測結(jié)果的差異。方法按照《中國藥典》(2010年版,三部)不溶性微粒規(guī)定的光阻法和顯微計數(shù)法對HBOCs制品進行檢測。結(jié)果實驗選取的5批次HBOCs制品不溶性微粒檢測結(jié)果均符合《中國藥典》(2010年版)相關(guān)要求;光阻法檢測結(jié)果明顯高于顯微計數(shù)法檢測結(jié)果;HBOCs溶液不同梯度稀釋后,顯微計數(shù)法檢測結(jié)果線性相關(guān)性分別為0.9095(10μm粒徑)和0.8255(25μm粒徑),而光阻法檢測結(jié)果線性相關(guān)性分別為0.1967(10μm粒徑范圍)和0.0283(25μm粒徑范圍)。結(jié)論選取的HBOCs制品不溶性微粒含量質(zhì)量總體情況較好;梯度稀釋法顯示,顯微計數(shù)法檢測HBOCs不溶性微粒結(jié)果具有較明顯的線性相關(guān)性,而光阻法檢測結(jié)果無明顯線性關(guān)系,二者檢測結(jié)果具有顯著差異。
[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.

【作者單位】： 中國醫(yī)學(xué)科學(xué)院北京協(xié)和醫(yī)學(xué)院輸血研究所;成都正康藥業(yè)有限公司;天津協(xié)和生物科技發(fā)展研究所;
【基金】：國家高新技術(shù)產(chǎn)業(yè)計劃(863)項目(2012AA021903-3) 四川省國際科技合作與交流研究計劃(2014HH0065)
【分類號】：R927.2
【正文快照】： 2.成都正康藥業(yè)有限公司;3.天津協(xié)和生物科技發(fā)展研究所)cle counter method;microscopy counting method;輸血是臨床治療救助的重要途徑,也是國家建立應(yīng)急體系的重要組成部分。隨著近年來臨床用血需求量的逐年增大,血液供應(yīng)緊張的局面日益加劇。另外,由于輸注全血存在著免疫，

本文編號：1455169