生物材料不同接触方式和条件对溶血作用影响的研究

Influence of Different Contact Ways and Extracting Conditions on the Hemolytic Effect of Biomaterials

采用直接接触和浸提液接触两种方法对聚 - D,L-乳酸 ( PDL L A)和 PVC输血粒料生物材料进行溶血性能的评价 ,其中浸提条件包括 3 7℃ 2 4h,3 7℃ 72 h,3 7℃ 12 0 h,5 0℃ 72 h和 70℃ 2 4h,在体外模拟生物体的温度与稀释兔血接触 ,相互作用一定时间后 ,测定其光吸收度 ,判断材料的溶血率 ,用以研究生物材料不同接触方式和浸提条件对溶血作用的影响。实验结果表明 ,对 PDL L A材料来讲 ,直接接触法与 3 7℃、不同浸提时间下所得的溶血率之间存在一定的差异 ( P<0 .0 5 ) ,但都归为合格的范围 ,而与 5 0℃和 70℃浸提条件下的溶血率相比则两者间的差异具有非常显著的统计学意义 ( P<0 .0 1) ;对 PVC输血粒料来讲 ,两种接触方式和几种材料浸提条件其溶血率之间的差异无统计学意义 ( P>0 .0 5 )。由此得出 ( 1) 3 7℃浸提 2 4～ 12 0 h,两种生物材料对红细胞有影响的可溶性成分溶出并不明显 ;( 2 ) 5 0℃和 70℃浸提条件 ,因被测材料的化学特性不同可出现溶血率的显著差异 ;( 3 )对一种未知的生物材料来讲 ,最好进行直接法和浸提法 (间接 )的同步试验 ,以从物理和化学双重角度较完整地评价材料的溶血性 ;( 4)当被测材料的化学性能允许的情况下 ,选用 5 0℃或

This assay was aimed to evaluate the influence of different contact ways and extracting conditions on the hemolytic effect of biomaterials. Using direct contact method and extract contact method, the hemolytic effect of PDLLA and PVC was assessed. The extracting conditions included: 37°C 24 h, 37°C 72 h, 37°C 120 h, 50°C 72 h, and 70°C 24 h. After the material or extract had been in contact with the diluted blood of rabbit for certain times, the hemolysis rate was calculated. The results for PDLLA showed that there were some differences between direct contact and extract contact at 37°C for different extraction time (p0.05). Our conclusions: (1) Under the extracting condition of 37°C from 24 h to 120 h, the soluble part of PDLLA and PVC that might influence erythrocyte did not dissolve considerably. (2) Under the extracting condition of 50°C and 70°C, the hemolysis rate may remarkably vary with the chemical characteristics of tested materials; (3) As to an unknown material, it is advisable to adopt two methods at the same time, one for direct contact and the other for extractcontact. Thus the hemolytic effect of biomaterials can be evaluated from physical and chemical angles. (4) In case that the chemical property of the sample can endure the test, the extracting condition at 50°C and 70°C may be of benefit to assessing the hemolytic effect of biomaterials. (5) The extract contact method as a supplemental test of direct contact method is of realistic significance.