一次性使用输液器细胞毒性来源及检测方法学研究

Study on the Source and Detection Method of Disposable Infusion Set Cytotoxicity

目的:一次性使用输液器细胞毒性来源探讨及检测新方法验证。为科学评价一次性使用输液器细胞毒性提供参考。方法:采用新一代CCK-8比色法,以输液器整体、各组件、导管部分、输液器原材料作为研究对象。结合常规克重浸提法及灌注浸提新方法对一次性使用输液器细胞毒性来源进行评估。结果:CCK-8法在本研究历次试验中均符合质控要求;将4种导管材质[聚氯乙烯(PVC)(增塑剂DEHP)、PVC(增塑剂TOTM)、热塑性聚氨酯弹性体(TPU)、聚烯烃热塑性弹性体(TPE)]输液器样品采用克重法整体浸提,两种PVC导管材质输液器显示潜在细胞毒性;PVC导管占输液器整体克重比越高,输液器采用克重法整体浸提细胞毒性越大;输液器PVC、TPU导管部件单独采用克重法浸提观察到更为明显的细胞毒性,其他部件未观察到潜在细胞毒性;输液器PVC导管料克重法浸提显示潜在的细胞毒性;灌注法结果提示,PVC、TPU导管材质输液器具有潜在细胞毒性,而TPE导管材质输液器无潜在细胞毒性。结论:一次性使用输液器细胞毒性来源为输液器导管部分,相较PVC及TPU,TPE材质导管具有相对较低的细胞毒性。灌注法相对常规克重法更适合一次性使用输液器细胞毒性评价。

Objective:To explore the source of disposable infusion set cytotoxicity and verify a new detection method,in order to provide a guidance for scientific evaluation of disposable infusion set cytotoxicity.Methods:CCK-8 method was used to study the components,catheter,and the raw materials of the infusion set.The conventional weight extraction method and the new perfusion method were combined to evaluate the source of the disposable infusion set cytotoxicity.Results:The CCK-8 method met the quality control requirements in all the experiments in this study.Four kinds of catheter materials[PVC(plasticizer DEHP),PVC(plasticizer TOTM),TPU,TPE]infusion samples were extracted by gram weight method.Two kinds of PVC catheter materials infusion sets showed potential cytotoxicity.As the weight ratio of the PVC catheter increases in infusion set,the overall infusion set cytotoxicity elevates with the use of weight extraction method.More obvious cytotoxicity was observed when the PVC and TPU catheter components of the infusion set were extracted alone using the gram weight method.While no potential cytotoxicity was observed for other components.The raw material of PVC tubing for infusion sets shows potential cytotoxicity.The perfusion method further suggests that infusion sets with PVC and TPU catheter materials are potentially cytotoxic,while TPE catheter materials show no potentially cytotoxic.Conclusion:Disposable infusion set cytotoxicity comes from the infusion set catheter.TPE catheter shows relatively lower cytotoxicity than PVC and TPU.Compared with conventional weight extraction method,the perfusion method is more suitable for the evaluation of disposable infusion set cytotoxicity.