纳米羟基磷灰石/聚苯硫醚复合材料在体内的生物相容性

摘要

背景:目前缺少纳米羟基磷灰石/聚苯硫醚复合材料生物相容性的相关研究.目的:在已完成的体外生物相容性研究基础上,评价纳米羟基磷灰石/聚苯硫醚复合材料的体内生物相容性.方法:①全身毒性实验:分别在SD大鼠腹腔注射纳米羟基磷灰石/聚苯硫醚复合材料浸提液与生理盐水,注射72 h后,观察大鼠一般情况、体质量及肝肾组织学变化;②迟发型超敏反应实验:在SD大鼠背部皮内分别注射纳米羟基磷灰石/聚苯硫醚复合材料浸提液与生理盐水,注射72 h内,观察皮肤刺激症状;③局部反应实验:在SD大鼠背部皮内分别植入纳米羟基磷灰石/聚苯硫醚复合材料与聚乙烯材料,植入15,30 d后,观察植入材料及其周围组织病理变化.结果与结论:①腹腔注射纳米羟基磷灰石/聚苯硫醚复合材料浸提液后,大鼠一般情况良好,体质量稳步增长,与对照组无差异(P＜0.05),肝肾脏器形态、色泽均正常,参照毒性程度分级,判定复合材料全身毒性分级属正常级别;②大鼠背部皮下注射纳米羟基磷灰石/聚苯硫醚复合材料浸提液后,未见明显皮肤刺激症状,原发性刺激指数＜0.4,提示复合材料超敏反应程度属极轻微范畴;③纳米羟基磷灰石/聚苯硫醚复合材料植入大鼠背部皮下后,未见明显降解吸收及排异反应发生,接触面组织炎性反应程度(15 d≤Ⅲ级,30 d≤Ⅱ级)及纤维囊厚度(15d≤Ⅲ级,30 d≤Ⅱ级)均提示材料与周围组织相容性良好;④结果表明,纳米羟基磷灰石/聚苯硫醚复合材料具有良好的体内生物相容性.%BACKGROUND:There is a lack of the research concerning the biocompatibility of nano-hydroxyapatite/polyphenylene sulfide (nHA/PPS) composites.OBJECTIVE:To evaluate the in vivo biocompatibility of nHA/PPS composites based on the completed research in vitro.METHODS:Systemic toxicity test:Sprague-Dawley rats were given the intraperitoneal injection of nHA/PPS extract or normal saline.The general situation,body mass and the histological changes of the liver and kidney were observed at 72 hours after injection.Delayed type hypersensitivity test:nHA/PPS extract or normal saline was injected subcutaneously into the back of the rats.Afterwards,skin irritation symptoms were observed at 72 hours.Local reaction experiment:nHA/PPS composites and polyethylene were respectively implanted into the back of the rats.The pathological changes of the implanted materials and their surrounding tissues were observed at 15 and 30 days after implantation.RESULTS AND CONCLUSION:(1) The rats were in good situation after nHA/PPS injection;the body mass increased steadily,which showed no significant difference from the control group (P ＜ 0.05);the morphology and color of the liver and kidney were normal,and the systemic toxicity of the composite materials was normal according to the degree of toxicity classification.(2) There were no obvious skin irritation symptoms after the subcutaneous injection of nHA/PPS composites,and the primary irritation index was less than 0.4,suggesting a low hypersensitivity.After implantation of nHA/PPS composites,there was no obvious degradation,absorption and rejection,and both the degree of inflammatory reaction (15 days ≤ level Ⅲ,30 days ≤ level Ⅱ) and the thickness of fibrous capsule (15 days ≤ level Ⅲ,30 days ≤ level Ⅱ) revealed the good biocompatibility of the composites.These results suggest that the nHA/PPS composites hold an excellent biocompatibility in vivo.