[Influence of different contact ways and extracting conditions on the hemolytic effect of biomaterials].

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, we assessed the hemolytic effect of PDLLA and PVC. The extracting conditions included: 37 degrees C 24 h, 37 degrees C 72 h, 37 degrees C 120 h, 50 degrees C 72 h, and 70 degrees 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 there were some differences between direct contact and extract contact at 37 degrees C for different extraction time (P < 0.05), but the hemolysis rates, lower than 5%, were in accord with the requirements of medical devices. However, under the condition of 50 degrees C and 70 degrees C, there were significant differences when extract contact method was compared with direct method (P < 0.01). For PVC, there was no statistically significant difference under all conditions (P > 0.05). Our conclusions: (1) Under the extracting condition of 37 degrees 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 degrees C and 70 degrees 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 extracontact. 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 degrees C and 70 degrees 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.