【摘要】 目的评价人工关节经辐射灭菌后遗传毒性和血液相容性,探讨辐射灭菌在医用高分子生物材料灭菌中的应用。方法采用ISO11137标准方法检测初始污染菌回收率、校正因子,完成辐照灭菌的剂量设定;对灭菌合格的人工股骨体进行遗传和血液相容性评价。结果人工股骨样品上初始染菌量,需氧菌数平均波动在263~303cfu/件之间,真菌数波动在25~43 cfu/件之间;污染菌回收率范围为92.72%~96.15%。辐照灭菌处理的样品各剂量组与阴性对照组间经统计学检验比较均无显著性差异(P>0.05),未显示出遗传性毒性。经辐照灭菌后样品致溶血率为1.38%,在规定允许范围内。结论设定剂量辐照灭菌后的人工关节遗传和血液相容性好,辐照灭菌作为医用高分子生物材料使用具有良好的安全性。更多还原

【Abstract】 Objective To evaluate the genotoxicity and blood-compatibility of artificial joint sterilized with radiation and to explore the application of radiation sterilization in the sterilization of medical high-polymer biological materials.Methods Based on ISO11137,recovery rate and correction factor of the initial bioburden and the sterilization dose were determined.The artificial femur after qualified sterilization was tested for genotoxicity and blood biocompatibility.Results The range of initial bioburden was 263～303 cfu/item for aerobic bacteria and 25～43 cfu/item for fungi detected from the artificial femur samples and the recovery rates were 92.72%～96.15%.There was no significant difference between the groups treated with different dosages of radiation sterilization and the control groups(P>0.05),and the genotoxicity was not shown.The rate of hemolysis caused by the samples sterilized with radiation was 1.38%,which was within the acceptable range.Conclusion The genetic and blood compatibility of artificial joint sterilized with radiation at the set dose is good,and the radiation sterilization has good safety as a method for sterilization of the medical high-polymer biological materials.更多还原