Velayudhan Shiny, Anilkumar T V, Kumary T V, Mohanan P V, Fernandez A C, Varma H K, Ramesh P
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Biomedical Technology wing, Poojappura, Thiruvananthapuram, Kerala 695 012, India.
Acta Biomater. 2005 Mar;1(2):201-9. doi: 10.1016/j.actbio.2004.11.005. Epub 2005 Jan 12.
Hydroxyapatite (HAP) is undoubtedly a material suitable for repairing the defective bone tissue. However, the brittleness and non-malleability of HAP limit its clinical application as a cranioplastic analogue. To improve these properties, pliable, osteoconductive composites composed of HAP and ethylene vinyl acetate co-polymer (EVA) have been developed. This study reports the biocompatibility evaluation of the newly developed composite material. Composites of two compositions, containing 40 and 50 volume percentage of HAP, were evaluated. In vitro cell culture cytotoxity studies were carried out using L929 cell line. Intracutaneous irritation studies, and intramuscular implantation studies were carried out on rabbits. Cell culture studies showed that the composite was non-cytotoxic to mouse fibroblast cell line. Intracutaneous irritation studies did not show any gross signs of tissue reaction. Histological analysis after six months of implantation in the paravertebral muscles of rabbit showed that all the implants under study were covered with a thin soft tissue capsule. On the basis of these observations, we conclude that the composite materials are biocompatible and hence are a candidate material for implantation in the cranium.
羟基磷灰石（HAP）无疑是一种适合修复骨组织缺损的材料。然而，HAP的脆性和不可延展性限制了其作为颅骨修复类似物的临床应用。为改善这些性能，已研发出由HAP和乙烯-醋酸乙烯酯共聚物（EVA）组成的柔韧、具有骨传导性的复合材料。本研究报告了新研发的复合材料的生物相容性评估。对含有40%和50%体积百分比HAP的两种成分的复合材料进行了评估。使用L929细胞系进行了体外细胞培养细胞毒性研究。对兔子进行了皮内刺激研究和肌肉内植入研究。细胞培养研究表明，该复合材料对小鼠成纤维细胞系无细胞毒性。皮内刺激研究未显示任何组织反应的明显迹象。在兔子椎旁肌中植入六个月后的组织学分析表明，所有研究中的植入物均被一层薄的软组织包膜覆盖。基于这些观察结果，我们得出结论，该复合材料具有生物相容性，因此是一种可用于颅骨植入的候选材料。
