摘要
制备交联透明质酸凝胶膜并评价其生物相容性。本研究采用己二酸二酰肼作为交联剂制备交联透明质酸凝胶膜，并采用GB／T16886医疗器械生物学评价标准规定的方法，对凝胶膜进行体外溶血试验、细胞毒性试验、急性毒性试验、眼刺激试验、皮内反应试验、致敏试验以及鼠伤寒沙门氏菌回复突变试验、哺乳动物培养细胞染色体畸变试验和小鼠骨髓嗜多染红细胞微核试验等三项遗传毒性试验。结果表明交联透明质酸凝胶膜无溶血性、无眼刺激作用、无皮内刺激和致敏作用，未见急性毒性反应，细胞毒性0～1级；三项遗传毒性试验均为阴性。交联透明质酸凝胶膜具有良好的生物相容性，是一种理想的医用生物材料。
To prepare and evaluate the biocompatibility of the cross- linked hyaluronic gel film, the studies on its cytotoxicity and hemolysis in vitro, acute systemic toxicity, eye stimulation, subcutaneous reactivity, sensitization and genotoxicity of the gel film were executed in compliance with the methods described in GB/T 16886. The experimental results showed that the gel film had no hemolysis, no acute systemic toxicity,no eye irritation, no subeutaneous reactivity, no sensitization, cytotoxicity was scored 0- 1 grade. The negative results in Ames test, mammalian cell chromosome aberration and micronucleus test demonstrated that the gel film had no genotoxicity. It＇ s concluded that the cross- linked hyaluronie gel film has reliable biocompatibility and maybe an ideal biomedical material.
出处
《生物医学工程研究》
2009年第2期104-107,共4页
Journal Of Biomedical Engineering Research
关键词
交联透明质酸凝胶
制备
生物相容性
毒性
Cross- linked hyaluronic gel
Preparation
Biocompatibility
Toxicity
