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透析器溶血试验方法改进研究

Study on the improvement of hemolysis test method for dialyzer
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摘要 目的对当前的溶血试验方法进行优化,使其可甄别有不良事件发生的透析器。方法从两方面优化现有的溶血试验方法,一方面将中空纤维与红细胞悬液的静态接触时间从60min增加到100min,另一方面增加静态接触后将中空纤维在红细胞悬液中滑动20次的动态接触。用改进后的方法对2种有不良事件发生过的透析器及另外3种透析器进行溶血试验。结果2种有不良事件发生透析器的溶血率远大于其余3种透析器,改进后的溶血试验方法可甄别出2种不良事件透析器。结论优化后的溶血试验方法对高危透析器有一定的甄别作用。 Objective The current hemolysis test method is optimized to identify the dialyzers having adverse events.Methods The existed hemolysis test method was optimized from two aspects.On the one hand,the static contact time between the hollow fiber and the red blood cell suspension was increased from 60min to 100 min,and on the other hand,the dynamic contact was added,i.e.,the hollow fiber was slid 20 times in the red blood cell suspension after the static contact.Two dialyzers having adverse events and three other dialyzers were tested for hemolysis using the modified method.Results The hemolysis rate of the 2 dialyzers having adverse events was much higher than that of the other 3 dialyzers.The improved hemolysis test method can identify 2 dialyzers with adverse events.Conclusion The optimized hemolysis test method is useful to pick out the high-risk dialyzers.
作者 许建霞 付步芳 付海洋 XU Jian-xia;FU Bu-fang;FU Haiyang(Biomaterials Laboratory,National Institutes for Food and Drug Control,Beijing 102629,China)
出处 《中国血液净化》 CSCD 2023年第1期36-39,43,共5页 Chinese Journal of Blood Purification
关键词 透析器 中空纤维 溶血试验 动态接触 Dialyzer Hollow fiber Hemolysis test Dynamic contact
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  • 1Edenkotter A,Endres P,Nederlof B,et al.Thoughts and Progress.Artificial Organs.2008;32(12):962-969.
  • 2Seyfert UT,Biehl V,Schenk J.In vitro hemocompatibility testing of biomaterials according to the ISO 10993-4.Biomolecular Engineering.2002;19:91-96.

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