Effect of simulated body fluid formulation on orthopedic device apatite‐forming ability assessment
Effect of simulated body fluid formulation on orthopedic device apatite‐forming ability assessment
复制标题
模拟体液配方对骨科器械磷灰石形成能力评估的影响
DOI：
10.1002/jbm.b.35207
复制
发表时间：
2022
期刊：
影响因子：
--
通讯作者：
Goering, Peter L.
中科院分区：
文献类型：
--
作者：
Nguyen, Alexander K.;Nelson, Sarah B.;Skoog, Shelby A.;Jaipan, Panupong;Petrochenko, Peter E.;Kaiser, Aric;Lo, Linh;Moreno, Jose;Narayan, Roger J.;Goering, Peter L.
自体骨与骨科器械的整合是植入物长期成功的关键因素。通常认为材料-组织界面由羟基磷灰石层组成，因此植入后可自发生成该羟基磷灰石层的生物活性材料可改善患者结局。根据ISO 22317：2014标准“外科植入物-植入物材料磷灰石形成能力的体外评价”，可通过将材料浸泡在模拟体液（SBF）中并评价表面羟基磷灰石层的形成来评估生物活性性能声明;然而，试验方法的变化可能会改变羟基磷灰石的形成并导致假阳性评估。本研究的目的是确定SBF制剂对生物活性评估的影响。将Bioglass®（45 S5和S53 P4）和非生物活性Ti-6Al-4V暴露于不同钙离子和磷酸盐浓度以及支持离子浓度的SBF制剂。对所得羟基磷灰石层的扫描电子显微镜和X射线粉末衍射评价显示，与标准制剂相比，富含两倍或四倍钙和磷酸根离子浓度的SBF增加了羟基磷灰石晶体的尺寸和数量，并且可以在传统上被认为是非生物活性的表面上诱导羟基磷灰石结晶。改变其他离子的浓度，例如，碳酸氢盐，改变羟基磷灰石诱导时间，数量和形态。对于评价材料磷灰石形成能力以支持生物活性性能声明的研究，必须充分描述和控制试验方法参数。目前尚不清楚暴露于任何SBF制剂后的磷灰石形成是否代表体内生物学反应。应进一步制定ISO 23317标准试验方法，为磷灰石表征和结果解释提供额外指导。
Integration of native bone into orthopedic devices is a key factor in long‐term implant success. The material‐tissue interface is generally accepted to consist of a hydroxyapatite layer so bioactive materials that can spontaneously generate this hydroxyapatite layer after implantation may improve patient outcomes. Per the ISO 22317:2014 standard, “Implants for surgery – In vitro evaluation for apatite‐forming ability of implant materials,” bioactivity performance statements can be assessed by soaking the material in simulated body fluid (SBF) and evaluating the surface for the formation of a hydroxyapatite layer; however, variations in test methods may alter hydroxyapatite formation and result in false‐positive assessments. The goal of this study was to identify the effect of SBF formulation on bioactivity assessment. Bioglass® (45S5 and S53P4) and non‐bioactive Ti‐6Al‐4V were exposed to SBF formulations varying in calcium ion and phosphate concentrations as well as supporting ion concentrations. Scanning electron microscopy and X‐ray powder diffraction evaluation of the resulting hydroxyapatite layers revealed that SBF enriched with double or quadruple the calcium and phosphate ion concentrations increased hydroxyapatite crystal size and quantity compared to the standard formulation and can induce hydroxyapatite crystallization on surfaces traditionally considered non‐bioactive. Altering concentrations of other ions, for example, bicarbonate, changed hydroxyapatite induction time, quantity, and morphology. For studies evaluating the apatite‐forming ability of a material to support bioactivity performance statements, test method parameters must be adequately described and controlled. It is unclear if apatite formation after exposure to any of the SBF formulations is representative of an in vivo biological response. The ISO 23317 standard test method should be further developed to provide additional guidance on apatite characterization and interpretation of the results.