新型水凝胶人工髓核的短期生物相容性评价(英文)

Evaluation of the short-term biocom patibility of a new kind of hydrogel prosthetic nucleus

目的用一种由改良的聚乙烯醇水凝胶制成的新型人工髓核(Evergel),对其进行短期生物相容性评价。方法按照国家标准GB/T16886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,可以进行临床应用。

Aim To evaluate the short-term biocompatibility of a new ki nd of prosthetic nucleus-Evergel,which is made from the modified polyvinyl alcoh ol hydrogel.Methods According to China national standard GB /T16886docum ents,the toxicity o f Evergel prosthetic nucleus material was investigated by t he cytotoxicity test,sensitization test,haemoly sis test,Ames test,mice marr ow micronucleus test and chromosome aberration test of mammalian cell in vitro. Results This material had no cytoxicity,no s en-sitivity,no obvious haemolysi s,an d no mutagencity in Ames test,mice marrow micronucleus test and chromo so me aberration test of mammalian cell in vitro.Conclusion The Evergel prosthetic nucleus has a good biocom-patibility and can be used clinically