消毒灭菌处理对连续碳纤维增强聚烯烃复合材料生物力学影响的实验研究

目的：探讨消毒灭菌处理对连续碳纤维增强聚烯烃复合材料生物力学的影响,为临床使用时选择合适的消毒灭菌方法提供实验依据。方法：连续碳纤维增强聚烯烃复合材料棒80根,分8组,每组10根,其中1组不经任何处理直接进行力学测试作为空白对照,其余7组分别进行高压蒸汽、2％戊二醛浸泡、环氧乙烷、75％酒精浸泡、钴-60（A）11 kGy、钴-60（B）25 kGy、钴-60（c）18 kGy消毒灭菌处理;分别进行弯曲、压缩力学测试,测定最大载荷、极限强度、弹性模量,比较各组之间的差异,了解消毒灭菌处理后复合材料生物力学的变化。结果：与空白对照组相比,高压蒸汽、钴-601射线辐照（11、18、25 kGy）处理使碳纤维增强聚烯烃复合材料棒的生物力学有降低趋势,且差异有统计学意义;环氧乙烷灭菌、2％戊二醛浸泡（12h）、75％酒精浸泡（12h）处理后,复合材料的生物力学也呈降低趋势,但差异没有统计学意义。结论：碳纤维增强聚烯烃复合材料形成产品作无菌包装时,应避免应用高压蒸汽和钴-60γ射线辐照作为灭菌处理方法;环氧乙烷灭菌、2％戊二醛浸泡灭菌（12h）、75％酒精浸泡（12h）均可作为复合材料的灭菌处理方法,考虑到产品批量生产作无菌包装的可操作性,建议采用环氧乙烷灭菌法可能较为合适;如欲采用1射线辐照法,为防范γ-射线对复合材料力学特性的影响,尚需作进一步的工艺改进。

Influence of sterilization treatments on continuous carbon-fiber reinforced polyolefin composite

OBJECTIVE: To evaluate the influence of sterilization treatment on continuous carbon-fiber reinforced polyolefin composite (CFRP) so as to provide experimental reference for selection of sterilization method for CFRP. METHODS: Seventy bars of CFRP were divided into 7 equal groups to undergo sterilization by autoclave, 2% glutaraldehyde soaking, 75% alcohol soaking, ethylene oxide sterilization, and Co-60 gamma ray irradiation of the dosages 11 kGy, 25 kGy, and 18 kGy respectively, and another 10 bars were used as blank controls. Then the bars underwent three-point bending test and longitudinal compression test so as to measure the biomechanical changes after sterilization treatment, including the maximum load, ultimate strength, and elastic modulus. RESULTS: Three-point bending test showed that the levels of maximum load of the all experimental groups were lower than that of the control group, however, only those of the 3 Co-60 irradiation groups were significantly lower than that of the control group and that Co-60 radiation lowered the level of maximum load dose-dependently; and that the levels of ultimate strength of all the all experimental groups were lower than that of the control group, however, only those of the 3 Co-60 groups were significantly lower than that of the control group and that the higher the dosage of Co-60 radiation the lower the level of ultimate strength, however, not dose-dependently. The elastic modulus of the Co-60 25 KGy group was significantly higher than that of the control group, and there was no significant difference in the level of ultimate strength among the other groups. Longitudinal compression test showed that the levels of maximum load and ultimate strength of the 3 Co-60 irradiation groups, autoclave group, and circular ethylene groups were significantly lower than that of the control group, and there was no significant difference in elastic modulus among different groups. CONCLUSION: During sterilized package of CFRP products produced in quantity autoclave sterilization and Co-60 gamma ray irradiation sterilization should be avoided. Ethylene oxide is proposed as the best sterilization method. If gamma ray irradiation is to be used further technology improvement is necessary.