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    胶原蛋白涂层人工血管的环氧乙烷灭菌工艺的可行性探讨

    Feasibility Discussion of Ethylene Oxide Sterilization Process for Collagen-Coated Artificial Blood Vessels

    • 摘要: 为了探究环氧乙烷灭菌对胶原蛋白涂层人工血管性能的影响,采用扫描电子显微镜-X射线能谱仪(SEM-EDS)、傅里叶变换红外光谱法(FTIR)、高效液相色谱法(HPLC)对环氧乙烷灭菌前后胶原蛋白涂层人工血管进行微观形貌表征、红外光谱表征和胶原蛋白鉴别,采用气相色谱法(GC)测定环氧乙烷灭菌后胶原蛋白涂层人工血管中环氧乙烷的残留量,并采用四甲基偶氮唑盐(MTT)法对环氧乙烷灭菌后的胶原蛋白涂层人工血管进行细胞毒性检测。结果表明,经环氧乙烷灭菌后的胶原蛋白未发生结构性的变化,可维持其固有的分子结构与有效含量。经环氧乙烷灭菌后的胶原蛋白涂层人工血管中环氧乙烷的残留量为1.85 μg·g−1P<0.005),满足安全标准,且细胞存活率为84.01%,满足临床的使用要求。

       

      Abstract: To investigate the impact of ethylene oxide sterilization on the properties of collagen-coated artificial blood vessels, the microscopic morphology, infrared spectroscopy, and collagen identification of collagen-coated artificial blood vessels before and after ethylene oxide sterilization were characterized using scanning electron microscopy-energy dispersive spectrometer (SEM-EDS), Fourier transform infrared spectroscopy (FTIR), and high performance liquid chromatography (HPLC). Gas chromatography (GC) was employed to determine the residual ethylene oxide in the collagen-coated artificial blood vessels after ethylene oxide sterilization. Additionally, the cytotoxicity of the collagen-coated artificial blood vessels after ethylene oxide sterilization was evaluated using the tetrazolium (MTT) assay. As shown by the results, the collagen-coated artificial blood vessels after ethylene oxide sterilization underwent no structural changes, maintaining its intrinsic molecular structure and effective content. The residual amount of ethylene oxide in the collagen-coated artificial blood vessels after ethylene oxide sterilization was 1.85 μg·g1P<0.005), complying with safety standards. Additionally, the cell viability rate was 84.01%, meeting essential requirements for clinical application.

       

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