摘要
目的:对新型可吸收材料PLLA/PLLA-gHA的生物相容性进行综合性评价。方法:依据IS010993系列标准和GB/T16886系列标准,对新型可吸收材料PLLA/PLLA-gHA进行急性全身毒性实验、溶血实验、肌肉内种植实验和皮内反应实验。小鼠尾静脉注射新材料浸提液,观察注射后各时相点动物的一般状态、毒性表现等指标以评价急性全身毒性反应。在100g·L-1新材料浸提液加入新鲜抗凝兔血,用分光光度计测取吸光度并计算溶血率。白兔背部皮下注射新材料浸提液,观测各注射点的红斑和水肿情况。将PLLA/PLLA-gHA板植入白兔竖脊肌内,于各时相点抽取兔静脉血检测血液学指标,在术后第14、30、60、90、180和360天取材,行大体标本和病理组织切片观察。结果:新型可吸收材料PLLA/PLLA-gHA组白兔一般状态良好,无急性全身毒性反应,实验组与对照组各期血液学指标AST、Scr,比较差异无显著性(P>0.05),新材料浸提液的溶血率为1.22%,低于标准规定的5%;皮下反应实验,各时相点组织水肿极轻微,无红斑形成;肌内植入PLLA/PLLA-gHA板实验,其早期炎性细胞侵润变化规律与对照组类似,符合一般的炎症变化转归规律,材料周围的包膜随植入时间的延长逐渐变薄,术后第360天时纤维化囊壁向材料内长入,囊壁形成程度为Ⅰ级以下。结论:新型可吸收材料PLLA/PLLA-gHA具有良好的生物相容性和安全性。
Objective To make a comprehensive evaluation of nano-composite of poly （L-lactide） and surface grafted hydroxyapatite （PLLA/PLLA-gHA） as a new material. Methods According to the evaluated critera of medical implanted materials biology and animal trial recommended in GB/T 16886 and IS0 10993 criterion, the new material was carried out on acute systemic toxicity test, haemolysis test, muscular implantation test and subcutaneous injection test. The extract liquid of new material was injected into mice by vena caudalis to test common station, toxic reaction of it at different time, the results were used to evaluate the acute systemic toxicity. Fresh anticoagulant cony blood was mixed with extract liquid of new material with density of 100 g· L^-1 to measure each absorbance with spectrophotometer and work out the corresponding rate of haemolysis. The red punctuation and hydropsia of rabbits were observed at different time by subcuntaneous injecting extract liquid into the back of rabbits. PLLA/PLLA-gHA composite plates were implanted into the sacrospinal muscle of rabbits. Cony venous blood was extracted to detect indicatrix of hematology at diferrent time. The material and surrounded tissues were taken out from animals at the 14th, 30th, 60th, 90th, 180th, 360th day to examine anatomic and pathological changes. Results Rabbits with PLLA/PLLA-gHA composite had good general condition. There was no any acute systemic toxicity in vivo. Data of AST and Scr had no significant difference between experimental group and control group. The hemolysis rate of extrac liquid was 1.22%, which was under the standard criteria （5%）. No red punctuation and light hydropsia were observed at different time in the subcutaneous injection test. The inflammation cytochange of PLLA/PLLA-gHA composite group was similar with that of control group in early days, which was met with the general regularity of inflammatory outcome. The fibrosis membrane surrounding the PLLA/PLLA- gilA composite became thinner gradually with the elongation of implantation time. The fibrosis membrane grew into the material at the 360th day. The degree of the fibrosis membrane was below classⅠ. Conclusion The new absorbable type PLLA/PLLA-gHA composite has excellent bioeompatibility and security.
出处
《吉林大学学报（医学版）》
CAS
CSCD
北大核心
2008年第1期14-18,共5页
Journal of Jilin University：Medicine Edition
基金
国家自然科学基金资助课题(30670563)
吉林省科技厅基金资助课题(20030423-01)
