Evergel人工髓核的生物相容性评价

Evaluation of the Biocompatibility of the Evergel Prosthetic Nucleus

目的 对一种由改良的聚乙烯醇水凝胶制成的新型人工髓核———Evergel进行生物相容性评价。方法 按照国家标准GB/T16 886的要求 ,对Evergel人工髓核材料进行了包括细胞毒性试验、致敏试验、溶血试验、Ames试验、小鼠骨髓细胞微核试验和哺乳细胞体外染色体畸变试验在内的毒理学测试。结果 Evergel人工髓核材料无细胞毒性作用 ,无致敏性 ,无明显的溶血现象。Ames试验、小鼠骨髓细胞微核试验和哺乳细胞体外染色体畸变试验结果显示材料无致突变性。结论 Evergel人工髓核材料具有良好的生物相容性 。

Purpose. To evaluate the biocompatibility of a new kind of prosthetic nucleus - Evergel, which is made from the modified polyvinyl alcohol hydrogel. Methods. According to China national standard GB/T16886 documents, the toxicity of Evergel prosthetic nucleus material is invested by the cytotoxicity test, sensitization test, haemolysis test, Ames test, mice marrow micronucleus test and chromosome aberration test of mammalian cell in vitro. Results. This material has no cytoxicity, no sensitivity, no obvious haemolysis, and no mutagencity in Ames test, mice marrow micronucleus test and chromosome aberration test of mammalian cell in vitro. Conclusions. The Evergel prosthetic nucleus has a good biocompatibility and can be used clinically.