中国组织工程研究 ›› 2010, Vol. 14 ›› Issue (38): 7091-7094.doi: 10.3969/j.issn.1673-8225.2010.38.015

• 材料生物相容性 material biocompatibility • 上一篇    下一篇

血液透析器中空纤维体外血液相容性的评价

许建霞,奚廷斐   

  1. 中国药品生物制品检定所,北京市 100050
  • 出版日期:2010-09-17 发布日期:2010-09-17
  • 作者简介:许建霞★,女,1976年生,山西省运城市人,汉族,2003年中国药品生物制品检定所毕业,硕士,助理研究员,主要从事医疗器械生物学评价方面的研究。xujianxia@nicpbp.org.cn

In vitro hemocompatibility of hollow fiber in hemodialyzer

Xu Jian-xia, Xi Ting-fei   

  1. National Institute for the Control of Pharmaceutical and Biological Products, Beijing   100050, China
  • Online:2010-09-17 Published:2010-09-17
  • About author:Xu Jian-xia★, Master, Assistant investigator, National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China xujianxia@nicpbp.org.cn

摘要:

背景:血液透析器中的中空纤维与肾透析患者的血液有大面积长时间的接触,对其进行血液相容性评价尤为重要。
目的:通过对一种透析器中空纤维血液相容性的2次评价,拟初步建立透析器体外血液相容性评价的方法。
方法:将样品透析器中的中空纤维截为3 cm长,取100根置于硅化玻璃管中,作为一个样品。两次评价试验中,选用不同的已经上市的血液透析器的中空纤维作为对照,对照中空纤维取与样品中空纤维相近表面积的数量,同样处理。每个硅化玻璃管中加入新鲜全血1.2 mL,放在置于37 ℃隔水培养箱的略倾斜的旋转培养器上,以30 r/min的速率旋转。30 min后取各硅化玻璃管中的全血,用于血细胞分析、凝血分析及血清总补体的检测。
结果与结论:与两个对照透析器中空纤维相比,样品透析器中空纤维在不同指标上显示出一定差异,但样品透析器对纤维蛋白原和血小板的巨大消耗作用在2次试验中均有充分体现,且与对照参数差值的绝对值相对于对照参数的百分比远大于15%,可以认为样品透析器中空纤维与对照透析器中空纤维之间血液相容性的差异不被接受,说明实验中所使用的体外血液相容性评价方法具有很好的重现性。

关键词: 血液透析器, 中空纤维, 体外评价, 方法, 血液相容性

Abstract:

BACKGROUND: The hollow fiber in hemodialyzer has a large-scale and long-time contact with the blood of the renal dialysis patients. The evaluation of the hollow fiber’s hemocompatibility is very important.
OBJECTIVE: The evaluation method of in vitro hemocompatibility of the hemodialyzer was primarily established by twice evaluating hollow fiber’s hemocompatibility in a hemodialyzer.
METHODS: The hollow fiber of the sample hemodialyzer was cut into 3-cm length, and 100 hollow fibers were put into the silicified glass tube as a sample. In this experiment, the sample hemodialyzer was tested twice with two different commercially available hemodialyzers as controls. The similar surface-area hollow fiber of the control hemodialyzers was disposed in the same way. 1.2 mL fresh human blood was added into every silicified glass tube, then all tubes was put onto the slightly sloping rotary incubator at 37 ℃ and rotated at the speed of 30 r/min for 30 minutes. Finally, the blood in all silicified glass tubes was detected for blood cell analysis, coagulation analysis and serum total complements activity determination respectively.
RESULTS AND CONCLUSION: Different parameters exhibited significant differences between the sample hollow fiber and two control hollow fibers. But the remarkable consume of fibrinogen and platelet was similar in the two tests, and the “|(parameter of sample-parameter of control)|/parameter of control ×100%” was far greater than 15%.So the difference on the hemocompatibility between the sample hollow fiber and control hollow fibers is not acceptable, which indicates that the in vitro hemocompatibility evaluation method has a good reproducibility.

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