琼脂糖胶原防粘连膜的生物相容性研究

The Biocompatibility Evaluation of Agarose Collagen Anti-adhesive Film

目的:旨在研究琼脂糖胶原防粘连膜的生物相容性,为其临床应用提供实验依据。方法:依据GB/T16886-ISO10993相关标准,通过体外细胞毒性试验、迟发型超敏反应试验、皮内刺激试验、急性全身毒性试验、溶血试验、Ames试验、皮下植入试验来评价琼脂糖胶原防粘连膜的生物相容性。结果:琼脂糖胶原防粘连膜有轻微细胞毒性、无致敏性、无皮内刺激性、无急性全身毒性、无溶血性、无遗传毒性,皮下植入后1周和4周,局部组织有炎症反应,植入后12周,炎症反应明显减轻,植入期内可见材料缓慢降解。结论:该琼脂糖胶原防粘连膜材料具有良好的生物相容性,符合临床使用要求。

Objective： To explore the biocompatibility of agarose collagen anti-adhesive film to provide experimental bases for clinical applications. Methods： According to the standard GB/T16886-ISO10993, to evaluate the biocompatibility of agarose collagen anti-adhesive film using the cytotoxicity test, guinea pig maximization test, animal Intracutaneous（intradermal） reactivity test, acute systemic toxicity test, haemolysis test, Ames test and subcutaneous implant test. Results： There was mild cytotoxicity, no sensitization, no intradermal reactivity, no acute systemic toxic reactivity, no hemolysis and no mutagenicity in Ames test. And, the result of subcutaneous implant test showed that the samples had local tissue irritation on 1 and 4 weeks after implantation, and mild irritation on 12 weeks. Conclusions： These results suggest that agarose collagen anti-adhesive film has favourable biocompatibility and meets the requirements for clinical applications.