两种试验方法评价可吸收医疗器械溶血性能的比较

Comparison of two test methods for evaluating hemolytic properties of absorbable material devices

目的使用两种试验方法评价可吸收医疗器械的溶血性能,并对其结果是否一致进行探讨,分析存在差异的原因。方法选取六种可吸收医疗器械,按GB/T16886.12推荐的浸提比例,采用生理盐水作为浸提介质,分别使用直接接触法和间接接触法评价其溶血性能,并比较实验终点浸提液pH变化。结果医用可吸收缝合线(PGLA)、医用可吸收止血纱布(氧化再生纤维素)、可降解药物洗脱支架(PDLGA)三组样品采用两种方法检测时溶血率有显著性差异(P<0.01)。结论在本实验条件下,材料和或其降解产物偏酸性、含药器械药物的释放是引起溶血率升高的主要因素,建议同时使用直接接触法和间接接触法评价可吸收医疗器械或材料的溶血性能。

ObjectiveThe aim of this study was to evaluate the hemolytic properties of absorbable medical devices by two different test methods.The consistency of the results was discussed,and the reasons for the differences were analyzed.Methods Six kinds of absorbable medical devices were selected.According to the extraction ratio recommended in GB/T 16886.12,normal saline was used as the extraction.The hemolytic properties were evaluated by direct contact method and indirect contact method respectively,and the changes in pH value were compared.Results There were significant differences(P<0.01)between the three groups of samples such as Medical absorbable suture(PGLA),Medical absorbable hemostatic gauze(Oxidized regenerated cellulose)and Degradable drug-eluting stent(PDLGA).Conclusion Under the conditions of this experiment,the pH value and the release of drugs were the main factors causing the higher hemolysis rate.It is suggested that use both direct contact method and indirect contact method to evaluate the hemolytic properties of absorbable medical devices or materials.