新型人工髓核材料果胶/聚乙烯醇复合水凝胶生物相容性研究

目的对新型人工髓核材料果胶/聚乙烯醇复合水凝胶（Pectin/PVA composite hydrogel,CoPP）进行生物组织相容性评价。方法按照国家标准GB/T16886的评价要求,对CoPP人工髓核材料进行致敏试验和遗传毒性试验等毒理学测试。结果注射CoPP材料浸提液豚鼠各观察时点均未见皮肤出现红斑、水肿等皮肤刺激反应,表明CoPP髓核材料浸提液对皮肤无致敏性。CoPP人工髓核材料浸提液各剂量组对TA97、TA98、TA100、TA102的回变菌落数,在加与不加大鼠肝微粒体酶（S9）条件下,均与自发回变数相近,也未呈现剂量反应关系。CoPP髓核材料浸提液各剂量组中微核出现率和染色体畸变率与阴性对照组比较差异无显著性（P〉0.05）。结论 CoPP人工髓核材料无致敏性和遗传毒性,具有良好的生物相容性。

Evaluation of the Biocompatibility of the Pectin/PVA Composite Hydrogel as a New Prosthetic Nucleus Material

Objective To evaluate the biocompatibility of a new kind of prosthetic nucleus—Pectin/PVA composite hydrogel（CoPP） .Methods According to China national standard GB/T16886 documents,the toxicity of CoPP prosthetic nucleus material is investigated by the sensitization test,Ames test,mice marrow micronucleus test and chromosome aberration test of mammalian cell in vitro.Results The mice had no allergic reaction after they were injected with the extract of CoPP.The results of Samonella typhimurium reverse mutation test showed that there were no significant effect on the number of histidine revertants of TA97,TA98,TA100 and TA102 strains after CoPP was added.The micronucleus rate of bone marrow cell were less than 5‰,there were no significant difference compared with the negative control group（P0.05） .The positive rate of chromosome aberration test was less than 5%,no significant difference was seen between Copp with negative group.Conclusions The CoPP prosthetic nucleus has a good biocompatibility and can be used clinically.