课题背景：目前对软骨合并软骨下骨损伤的治疗效果欠佳。n-HA+PA66是新型纳米粒晶的骨修复替代材料，实验旨在评价新型生物复合材料PVA/n-HA+PA66修复关节软骨及软骨下骨的生物安全性。

应用要点：PVA/n-HA+PA66是一种新型一体化生物复合材料，是将两种材料有机地结合在一起。实验结果表明：该复合材料无毒，无刺激性，具有良好的生物相容性和生物安全性，是一种有较广阔应用前景的生物材料。

同行评价：本文通过常规的5种生物实验说明了PVA/n-HA+PA66复合材料具有良好的生物相容性和生物安全性，其研究具有很好的科研价值.

摘要
目的：采用动物体内实验的方法评价新型修复关节软骨及软骨下骨的复合材料PVA/n-HA+PA66的生物相容性。
方法: 实验于2006-09/2007-03 在四川大学华西医院组织工程实验室完成。制备PVA/n-HA+PA66浸提液，进行以下实验：①急性全身毒性实验：取SD大鼠随机分为2组，分别腹腔注射20%浸提液和生理盐水1 mL,观察动物行为学及体质量变化。②溶血实验：取抗凝兔血加入复合材料粉末后测溶血率。③皮内刺激实验：在新西兰大白兔背部皮内注射浸提液，观察注射浸提液后注射部位的红斑和水肿状况。④皮下植入实验及慢性毒性实验：在SD大鼠背部皮下植入材料，术后2，4，8周取材,观察材料植入皮下后与周围组织的反应情况。术后12周抽血行肝肾功能检测，评价材料对动物有无长期毒性。
结果:①急性全身毒性实验小鼠活动正常，大鼠体质量均呈上升趋势，且两组体质量增加比较差异无显著性意义。②3 种浓度梯度的复合材料,溶血率均未超过5%,达到标准要求。③皮内刺激实验:实验侧及阴性对照侧各注射点均未见明显皮肤刺激症状。 ④长期毒性实验：术后12周小鼠肝肾功能与正常对照组及术前比较无显著性差异（P > 0.05），组织学切片显示血管和纤维组织进入复合材料网孔中，与复合材料连为一体，未产生排斥反应。
结论: 双相生物复合材料PVA/n-HA+PA66具有良好的生物相容性。
关键词: PVA/n-HA+PA66；生物复合材料；生物相容性；组织相容性；血液相容性；生物材料

郭涛，杨天府，吴佳齐，刘洋，李玉宝，裴福兴.体内实验评价新型关节软骨修复材料聚乙烯醇/纳米羟基磷灰石+聚酰胺66的生物相容性[J].中国组织工程研究与临床康复，2008，12(1):31-34
[www.zglckf.com/zglckf/ejournal/upfiles/08-1/1k-31(ps).pdf]

Biocompatibility of polyvinyl alcohol/nano-hydroxyapatite+polyamide66 composite material in repairing articular cartilage in vivo

Abstract

AIM：This study observed the biocompatibility of a novel biological composite material in repairing articular cartilage and subchondral bone in animal bodies.
METHODS: The experiment was performed in Tissue Engineering Laboratory of West China Hospital from September 2006 to March 2007.①Acute general toxicity test: SD rats were randomized into two groups, and received peritoneal injection of 20% diffusion solution and 1 mL saline respectively. Change of activity and weight in experimental animals were observed.②Haemolysis test: Anticoagulant rabbit blood was added into the composite material powder to work out the rate of haemolysis.③Intradermal stimulation test: The stimulation reactions such as erythema and edema were observed after the diffusion solution was intradermally injected into the back of New Zealand rabbits.④Subcutaneous implantation test and chronic toxicity test: The back of SD rats were implanted with composite materials. Samples were harvested to observe the tissue reaction at 2, 4, 8 weeks. Liver and kidney functions were determined at 12 weeks to assess whether the material had long-term toxicity.
RESULTS: ①The rats' activity was normal in the acute toxicity test on the whole body. Animal's weight in experimental group was growing and there was no significant differences compared with the control group.②Haemolysis rate of rats to different concentrations of diffusion solution was < 5%, under the standard criteria.③Skin stimulating reactions were not found in the experimental group and negative control group by intradermal stimulation test.④In chronic toxic reaction, rat's liver and kidney function was not different compared with the control groups at 12 weeks and the index before operation (P > 0.05). Histological sections revealed that, the fibrous tissue and some blood vessels grew into the porous materials and became the whole structure with the composite materials, without rejecting reaction.
CONCLUSION: The diphase biological composite material PVA/n-HA+PA66 has good biocompatibility.

Guo T, Yang TF, Wu JQ, Liu Y, Li YB, Pei FX.Biocompatibility of polyvinyl alcohol/nano-hydroxyapatite+polyamide66 composite material in repairing articular cartilage in vivo.Zhongguo Zuzhi Gongcheng Yanjiu yu Linchuang Kangfu 2008;12(1):31-34(China)
[www.zglckf.com/zglckf/ejournal/upfiles/08-1/1k-31(ps).pdf]