新型纳米骨重建和修复材料羟基磷灰石/聚酰胺体内植入的生物相容性及安全性

Biocompatibility and security of new type nano hydroapatite crystals and polyamide for bone reconstruction and repair after implanting in vivo

目的评价新型纳米骨修复和重建材料纳米羟基磷灰石/聚酰胺(n-HA/PA66)植入动物体内后可能引发的急、慢性全身毒性反应及植入机体后对动物机体局部组织的影响,皮内刺激反应的潜在性和程度。方法:参照GB/T16886.5-1997-ISO10993-5:1992对医用植入材料的评价标准和所推荐的生物学和动物试验,将n-HA/PA66埋植在动物体肌肉内,在不同时相点抽血对血液常规、炎性指标、血生化指标及肝、肾功能指标进行检测,以评价急性全身性毒性反应;又在不同时相点取材,行大体标本和病理组织切片观察。以不同浓度的材料浸提液加入动物血样中,用分光光度计测取各自的吸光度并算出相应的溶血率。通过在动物背部皮内注射材料浸提液,在规定时相点观察并计算其刺激指数(PII)。结果:n-HA/PA66在动物体内的急慢性毒性反应为无毒,各期试验组和对照组各项化验结果组间差异无显著性意义(P>0.05),证实材料埋置动物体内后未引起明显的血常规、炎性指标、血生化指标及肝肾功能变化,病理组织切片示材料周围的包裹组织,其炎性变化符合一般的炎症变化转归规律;不同浓度的材料浸提液与血液混溶的溶血率均<3%,低于标准规定的5%;动物背部皮内注射材料浸提液后观察期原发性刺激指数(PII)均在0～0.4区间内,按标准刺激反应判为极轻微。结论:新型骨修?

AIM:To investigate the acute or chronic toxic reaction on the whole body induced by the new type nano hydroapatite crystals and polyamide composite (n HA/PA66) for bone reconstruction and repair after implanting in vivo and its effect on partial constitution of animal organs after implanting in vivo,and evaluate the potential and degree of subcuticular stimulation reaction. METHODS:According to the evaluated criteria of medical implanted materials,biology and animal trial recommended in GB/T16 886.5 1997 ISO 10 993 5:1992, n HA/PA66 composite was implanted into the muscle of animal and blood was drawn at different points.General and histochemical examinations of blood were performed at different points.The inflammation index,the biochemical index of blood and the functional indexes of liver and kidney were measured to evaluate the acute toxic reaction on the whole body. Diffusion solution at different concentrations was added into the sample of animal blood to measure each absorbance with spectrophotometer and work out the corresponding rate of haemolysis.The primary irritation index(PII) was worked out after observing at the rated point by subcutaneous injection into the back of animal. RESULTS:The results showed that the n HA/PA66 composite had no apparent inflammatory reaction in vivo.There was no obvious significance between the treatment group and control group at different period(P >0.05). There were no obvious changes in general blood,the indexes of inflammation and biochemical blood as well as the function of liver and kidney.Pathologic tissue section showed that the peripheral packed tissue of materials and the inflammation change accorded with the general regularity of inflammatory outcome;The rate of hemolysis to different concentration diffusion solution was < 3%,under the standard criteria(5%);The PII was measured 0-0.4 after the diffusion solution was injected into the back of animal,and the stimulation reaction was very slight according to the criteria. CONCLUSION:The new type n HA/PA66 composite for bone repair and reconstruction has good biocompatibility and security.