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聚-L-丙交酯电纺微纤维不同灭菌技术的比较研究:有效性与材料降解

Comparative study of different techniques for the sterilization of poly-L-lactide electrospun microfibers: effectiveness vs. material degradation.

作者信息

Rainer Alberto, Centola Matteo, Spadaccio Cristiano, Gherardi Giovanni, Genovese Jorge A, Licoccia Silvia, Trombetta Marcella

机构信息

Laboratory of Chemistry and Biomaterials, University Campus Bio-Medico of Rome, Rome, Italy.

出版信息

Int J Artif Organs. 2010 Feb;33(2):76-85.

Abstract

Electrospinning of biopolymeric scaffolds is a new and effective approach for creating replacement tissues to repair defects and/or damaged tissues with direct clinical application. However, many hurdles and technical concerns regarding biological issues, such as cell retention and the ability to grow, still need to be overcome to gain full access to the clinical arena. Interaction with the host human tissues, immunogenicity, pathogen transmission as well as production costs, technical expertise, and good manufacturing and laboratory practice requirements call for careful consideration when aiming at the production of a material that is available off-the-shelf, to be used immediately in operative settings. The issue of sterilization is one of the most important steps for the clinical application of these scaffolds. Nevertheless, relatively few studies have been performed to systematically investigate how sterilization treatments may affect the properties of electrospun polymers for tissue engineering. This paper presents the results of a comparative study of different sterilization techniques applied to an electrospun poly-L-lactide scaffold: soaking in absolute ethanol, dry oven and autoclave treatments, UV irradiation, and hydrogen peroxide gas plasma treatment. Morphological and chemical characterization was coupled with microbiological sterility assay to validate the examined sterilization techniques in terms of effectiveness and modifications to the scaffold. The results of this study reveal that UV irradiation and hydrogen peroxide gas plasma are the most effective sterilization techniques, as they ensure sterility of the electrospun scaffolds without affecting their chemical and morphological features.

摘要

生物聚合物支架的静电纺丝是一种全新且有效的方法,可用于制造替代组织,以修复缺损和/或受损组织,并直接应用于临床。然而,要全面进入临床领域,仍需克服许多与生物学问题相关的障碍和技术难题,比如细胞黏附及生长能力等。当旨在生产一种可现货供应、能在手术环境中立即使用的材料时,与宿主人体组织的相互作用、免疫原性、病原体传播以及生产成本、技术专长,还有良好生产规范和实验室规范要求等都需要仔细考量。灭菌问题是这些支架临床应用中最重要的步骤之一。然而,相对较少的研究系统地探究了灭菌处理如何影响用于组织工程的电纺聚合物的性能。本文展示了对应用于电纺聚-L-丙交酯支架的不同灭菌技术的对比研究结果:浸泡在无水乙醇中、干热灭菌和高压蒸汽灭菌处理、紫外线照射以及过氧化氢气体等离子体处理。形态学和化学表征与微生物无菌检测相结合,以在有效性和对支架的改性方面验证所研究的灭菌技术。本研究结果表明,紫外线照射和过氧化氢气体等离子体是最有效的灭菌技术,因为它们能确保电纺支架无菌,同时不影响其化学和形态特征。

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