Silva Viviane V, Lameiras Fernando S, Lobato Zélia I P
CNEN/CDTN-Comissão Nacional de Energia Nuclear/Centro de Desenvolvimento de Tecnologia Nuclear, R. Prof. Mário Werneck, s/n, Cidade Universitária, Pampulha, Belo Horizonte, MG, CP 941, CEP 30123-970, Brazil.
J Biomed Mater Res. 2002;63(5):583-90. doi: 10.1002/jbm.10308.
Materials and devices intended for end-use applications as implants and medical devices must be evaluated to determine their biocompatibility potential in contact with physiological systems. The use of standard practices of biological testing provides a reasonable level of confidence concerning the response of a living organism to a given material or device, as well as guidance in selecting the proper procedures to be carried out for the screening of new or modified materials. This article presents results from cytotoxicity assays of cell culture, skin irritation, and acute toxicity by systemic and intracutaneous injections for powders, ceramic bodies, and extract liquids of hydroxyapatite (HA), calcia partially stabilized zirconia (ZO), and two types of zirconia-hydroxyapatite composites (Z4H6 and Z6H4) with potential for future use as orthopedic and dental implants. They indicate that these materials present potential for this type of application because they meet the requirements of the standard practices recommended for evaluating the biological reactivity of ATCC cell cultures (CCL1 NCTC clone 929 of mouse connective tissue and CCL 81 of monkey connective tissue) and animals (rabbit and mouse) with direct or indirect patient contact, or by the injection of specific extracts prepared from the material under test. In addition, studies involving short-term intramuscular and long-term implantation assays to estimate the reaction of living tissue to the composites studied, and investigations on long-term effects that these materials can cause on the cellular metabolism, are already in progress.
作为植入物和医疗设备的最终用途材料和装置必须经过评估,以确定它们与生理系统接触时的生物相容性潜力。采用标准的生物学测试方法,可以在一定程度上合理地确定生物体对特定材料或装置的反应,并为筛选新的或改良材料时应采用的适当程序提供指导。本文介绍了对羟基磷灰石(HA)、部分稳定氧化锆(ZO)以及两种氧化锆 - 羟基磷灰石复合材料(Z4H6和Z6H4)的粉末、陶瓷体和提取液进行细胞培养细胞毒性试验、皮肤刺激性试验以及通过全身和皮内注射进行急性毒性试验的结果,这些材料未来有可能用作骨科和牙科植入物。结果表明,这些材料具有用于此类应用的潜力,因为它们符合推荐用于评估与ATCC细胞培养物(小鼠结缔组织的CCL1 NCTC克隆929和猴结缔组织的CCL 81)以及与患者有直接或间接接触的动物(兔子和小鼠)的生物反应性的标准测试方法的要求,或者符合对由受试材料制备的特定提取物进行注射测试的要求。此外,涉及短期肌肉注射和长期植入试验以评估活组织对所研究复合材料的反应的研究,以及关于这些材料对细胞代谢可能产生的长期影响的研究,也正在进行中。