灭菌对聚氨基酸/硫酸钙复合材料理化性能的影响

Influence of sterilization on physiochemical features of poly(amino acids)/calcium sulfate composite

目的探讨高温高压、γ射线、低温等离子、环氧乙烷及紫外线等不同灭菌方式对新型复合生物材料——聚氨基酸/硫酸钙[poly(amino acids)/calcium sulfate,PAA/CS]理化性能的影响。方法采用熔融缩聚法制备PAA/CS材料,按照不同灭菌方式灭菌后进行浸提液L929细胞毒性、材料结构X射线衍射分析、材料力学性能测试,并与灭菌前作对照。结果环氧乙烷、紫外线灭菌及阴性对照组细胞生长良好,各时间点细胞相对增殖率在90%以上,细胞毒性0～1级。其余各组细胞24h内基本死亡,细胞相对增殖率均在50%以下,细胞毒性3～4级。X射线衍射分析显示相对于灭菌前,各灭菌组材料结晶峰数目及形态无明显变化。低温等离子及高温高压灭菌组材料抗压强度分别为(250±4)、(187±17)MPa,较灭菌前明显下降(P<0.05),其余各组无明显变化(P>0.05)。结论环氧乙烷及紫外线灭菌对PAA/CS复合材料理化性能无明显影响,可作为该材料的灭菌方法。

Objective To investigate the influence of different sterilization methods,autoclave,gamma-irradiation,hypothermal plasma,ethylene oxide and ultroviolet,on the physiochemical features of a new composite biomaterial-poly（amino acids）/calcium sulfate（PAA/CS）.Methods PAA/CS composite was synthesized by melt polycondensation process.After the composite was sterilized by the aforementioned methods,L929 cells toxicity,structure analysis by X-ray diffraction and mechanical capacity of the composite were studied,and compared with before sterilization.Results The L929 cells in ethylene oxide,ultroviolet and negative control group were in well growth,cell relative growth rate（RGR） was beyond 90%,and cytotoxicity grading was between 0 and 1.Cells in other groups almost died in 24 h.The RGRs were below 50%,and cytotoxicity grading was between 3 and 4.The X-ray diffraction test demonstrated the number and morphology of crystallization peak of the composite had no visible change after sterilization.The compressive strength of the composite in the ethylene oxide and ultroviolet group was apparently decreased than that of the composite before sterilization（P0.05）,but the decrease was not seen in other group（P0.05）.Conclusion Ethylene oxide and ultroviolet have no apparent influence on the physiochemical features of the PAA/CS composite,therefore can be used to sterilize the composite.