Data from: Silver nanoparticles as a medical device in healthcare settings: a five-step approach for candidate screening of coating agents

Silver nanoparticle-based antimicrobials can promote a long lasting bactericidal effect without detrimental toxic side effects. However, there is not a clear and complete protocol to define and relate the properties of the particles (size, shape, surface charge, ionic content) with their specific activity. In this paper, we propose an effective multi-step approach for the identification of a ‘purpose-specific active applicability window’ to maximize the antimicrobial activity of medical devices containing silver nanoparticles (Ag NPs) (such as surface coaters), minimizing any consequent risk for human health (safety by design strategy). The antimicrobial activity and the cellular toxicity of four types of Ag NPs, differing in their coating composition and concentration have been quantified. Through the implementation of flow-field flow fractionation, Ag NPs have been characterized in terms of metal release, size and shape. The particles are fractionated in the process while being left unmodified, allowing for the identification of biological particle-specific contribution. Toxicity and inflammatory response in vitro have been assessed on human skin models, while antimicrobial activity has been monitored with both non-pathogenic and pathogenic Escherichia coli. The main benefit associated with such approach is the comprehensive assessment of the maximal effectiveness of candidate nanomaterials, while simultaneously indexing their properties against their safety.

基于银纳米颗粒的抗菌制剂可发挥持久杀菌功效，且无有害毒副作用。然而目前尚无清晰完整的方案，用于明确颗粒各项属性（尺寸、形貌、表面电荷、离子含量）与其特异性抗菌活性之间的关联。本文提出一种有效的多步方法，用于识别「特定用途活性适用窗口」，以最大化含银纳米颗粒（Ag NPs）的医用器件（如表面涂层）的抗菌活性，同时将对人类健康的潜在风险降至最低（即安全设计策略）。本研究对四种涂层组成与浓度各异的银纳米颗粒的抗菌活性与细胞毒性进行了定量分析。通过流场流分级分离法（flow-field flow fractionation）对银纳米颗粒的金属释放量、尺寸与形貌进行了表征。该过程中颗粒在保持未改性状态下完成分级分离，可明确颗粒本身对生物学效应的特异性贡献。研究以人体皮肤模型为载体，体外评估了颗粒的毒性与炎症反应；同时分别以非致病性与致病性大肠杆菌（Escherichia coli）为对象，检测了其抗菌活性。该方法的核心优势在于，可全面评估候选纳米材料的最优抗菌效能，同时将其属性与安全性进行关联对标。