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环氧乙烷灭菌后70:30聚(L-丙交酯-co-D,L-丙交酯)聚合物物理特性和机械强度的增强保留率

Enhanced retention of polymer physical characteristics and mechanical strength of 70:30 poly(L-lactide-co-D,L-lactide) after ethylene oxide sterilization.

作者信息

McManus Anastasia J, Moser Rodney C, Dabkowski Rhiannon B, Thomas Kevin A

机构信息

MacroPore Biosurgery, a Cytori Therapeutics Company, 3020 Callan Road, San Diego, California 92121, USA.

出版信息

J Biomed Mater Res B Appl Biomater. 2007 Aug;82(2):325-33. doi: 10.1002/jbm.b.30737.

Abstract

This study examined the effect of ethylene oxide (EtO) and electron beam (e-beam) irradiation on the properties of 70:30 poly(L-lactide-co-D,L-lactide). The effects of sterilization upon the polymer physical characteristics and strength retention of the material were examined, both initially and after being subjected to real time ageing. Commercially available 70:30 poly(L-lactide-co-D,L-lactide) material was fabricated into rectangular, cylindrical, screw, and sheet designs, and tested in compression, shear, or tension. Sterilization of 70:30 poly(L-lactide-co-D,L-lactide) by ethylene oxide had a nearly negligible effect on the physical properties of the polymer, regardless of specimen size or manufacturing technique. The molecular weight and inherent viscosity of the specimens decreased by approximately 3% after sterilization by EtO. However, sterilization of 70:30 poly(L-lactide-co-D,L-lactide) by e-beam irradiation resulted in immediate changes to some of the physical properties of the polymer. Specimens sterilized by e-beam irradiation displayed an immediate decrease in inherent viscosity of approximately 67% as compared to the respective nonsterile samples. The immediate decrease in inherent viscosity and molecular weight with e-beam irradiation required approximately 39 weeks of real time ageing of the EtO sterilized parts. At all time points investigated in the present study, the strength retention of the EtO sterilized devices equaled or exceeded that of the e-beam irradiated samples.

摘要

本研究考察了环氧乙烷(EtO)和电子束(e束)辐照对70:30聚(L-丙交酯-co-D,L-丙交酯)性能的影响。研究了灭菌对材料的聚合物物理特性和强度保持率的影响,包括初始阶段以及经过实时老化后的情况。将市售的70:30聚(L-丙交酯-co-D,L-丙交酯)材料制成矩形、圆柱形、螺旋形和片状设计,并进行压缩、剪切或拉伸测试。环氧乙烷对70:30聚(L-丙交酯-co-D,L-丙交酯)进行灭菌处理时,无论样品尺寸或制造工艺如何,对聚合物的物理性能影响几乎可以忽略不计。经环氧乙烷灭菌后,样品的分子量和特性粘度下降了约3%。然而,电子束辐照对70:30聚(L-丙交酯-co-D,L-丙交酯)进行灭菌处理后,聚合物的某些物理性能立即发生了变化。与各自的未灭菌样品相比,经电子束辐照灭菌的样品的特性粘度立即下降了约67%。电子束辐照导致特性粘度和分子量立即下降,这需要环氧乙烷灭菌部件经过约39周的实时老化。在本研究调查的所有时间点,环氧乙烷灭菌装置的强度保持率等于或超过电子束辐照样品。

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