Bhatnagar Divya, Dube Koustubh, Damodaran Vinod B, Subramanian Ganesan, Aston Kenneth, Halperin Frederick, Mao Meiyu, Pricer Kurt, Murthy N Sanjeeva, Kohn Joachim
NJ Centre for Biomaterials, Rutgers-The State University of New Jersey, 145 Bevier Road, Piscataway, NJ 08854, USA.
Johnson & Johnson Sterility Assurance, 930, US 202, Raritan, NJ 08669, USA.
Macromol Mater Eng. 2016 Oct;301(10):1211-1224. doi: 10.1002/mame.201600133. Epub 2016 Jul 11.
The effects of ethylene oxide (EO), vaporized hydrogen peroxide (VHP), gamma (γ) radiation, and electron-beam (E-beam) on the physiochemical and morphological properties of medical device polymers are investigated. Polymers with ether, carbonate, carboxylic acid, amide and ester functionalities are selected from a family of poly(ethylene glycol) (PEG) containing tyrosine-derived polycarbonates (TyrPCs) to include slow, medium, fast, and ultrafast degrading polymers. Poly(lactic acid) (PLA) is used for comparison. Molecular weight () of all tested polymers decreases upon gamma and E-beam, and this effect becomes more pronounced at higher PEG content. Gamma sterilization increases the glass transition temperature of polymers with high PEG content. EO esterifies the carboxylic acid groups in desaminotyrosol-tyrosine (DT) and causes significant degradation. VHP causes hydroxylation of the phenyl ring, and hydrolytic degradation. This study signifies the importance of the chemical composition when selecting a sterilization method, and provides suggested conditions for each of the sterilization methods.
研究了环氧乙烷（EO）、汽化过氧化氢（VHP）、γ辐射和电子束（E-beam）对医疗器械聚合物的物理化学和形态学性质的影响。从包含酪氨酸衍生聚碳酸酯（TyrPCs）的聚乙二醇（PEG）家族中选择具有醚、碳酸酯、羧酸、酰胺和酯官能团的聚合物，以包括缓慢、中等、快速和超快速降解的聚合物。聚乳酸（PLA）用于比较。所有测试聚合物的分子量在γ辐射和电子束作用下降低，并且在较高PEG含量时这种效应变得更加明显。γ灭菌提高了具有高PEG含量的聚合物的玻璃化转变温度。环氧乙烷使去氨基酪氨酸-酪氨酸（DT）中的羧酸基团酯化并导致显著降解。汽化过氧化氢导致苯环羟基化和水解降解。本研究表明在选择灭菌方法时化学成分的重要性，并为每种灭菌方法提供了建议条件。
