改性心室辅助装置材料的细胞毒性及溶血性试验

Cytotoxicity and hemolysis tests on modification materials of ventricular assisted devices

①目的通过细胞毒性试验和溶血性试验来筛选符合生物相容性要求的心室辅助装置材料。②方法 5种受试聚氨酯材料,制成60 cm23份,每份加入生理盐水注射液。取3支试管,每管加入生理盐水注射液作为阴性对照。取3支试管,每管加入蒸馏水作为阳性对照。全部试管置恒温水浴中保温,每支试管中加入稀释兔血,继续保温,吸出管内液体,离心后取上清液,测定其吸光度。上述材料灭菌后制备其浸提液,在含L-929细胞的培养皿的琼脂表面放置滴有材料浸提液的无菌滤纸片,培养箱避光培养后染色,最后在倒置相差显微镜下观测。③结果先接枝聚氨酯(APCU)、聚碳酸聚氨酯(PCU)、聚氨酯(PU)3种材料溶血率为0.3%、1.4%、0%,而先磺化聚氨酯(SPCU)及肝素化聚氨酯(HPU)溶血率为23.6%、12.1%;先接枝聚氨酯及聚碳酸聚氨酯毒性分级为0.6级和0.2级,而先磺化聚氨酯、肝素化聚氨酯及聚氨酯毒性分级为1.5级、1.5级和1.2级。④结论先接枝聚氨酯,聚碳酸聚氨酯和聚氨酯3种材料符合医用材料的溶血试验要求,先接枝聚氨酯及聚碳酸聚氨酯符合材料细胞毒性试验要求。

Objective To select the biocompatible requirements materials of the ventricular assisted device by cytotoxicity test and hemolysis test.Methods Five kinds of materials of polyurethane（APCU,PCU,PU,SPCU and HPCU）were divided into 3 parts（60cm2）,sodium chloride injection was added in each of materials（60cm2）.Sodium chloride injection was and added in three test-tubes as negative control and distilled water was added in three test-tubes as positive control.All of the test-tubes were placed in constant temperature water,dilution of rabbit blood was added to each test-tube and heated continuously,then the clear liquid was taken out after centrifugation and examined the optical density.The extraction of the materials after the sterilization was prepared.The sterile filter paper of the material extraction was laid on the agar surface including L-929 cells,incubated in incubator and dyed,then observed by inverted phase contrast microscope.Results The hemolytic rates of APCU,PCU,PU,SPCU and HPCU were 0.3%,1.4%,0%,23.6% and 12.1%,while the toxicity grades of APCU,PCU,SPCU,HPU and PU were 0.6,0.2,1.5,1.5 and 1.2 respectively.Conclusion APCU,PCU and PU accorded with the requirements of medical materials by hemolysis test,APCU and PCU accorded with the requirements of medical materials by cytotoxicity test.