注射用交联透明质酸钠凝胶生物相容性研究

Research on Biocompatibility of Cross-Linked Sodium Hyaluronate Gel for Injection

目的:评价注射用交联透明质酸钠凝胶的生物相容性。方法:分别通过细胞毒性试验、致敏试验、皮内反应试验、急性毒性试验、遗传毒性试验、植入试验、慢性毒性试验来全面评价注射用交联透明质酸钠凝胶的生物相容性。结果:试验结果显示,注射用交联透明质酸钠凝胶对L929细胞有轻度细胞毒性、无致敏反应、无遗传毒性、无急性和慢性毒性反应、皮内反应记分为1.5,植入试验4、13、26、52周各阶段评分为3.08、1.83、0.33、0,52周基本完成降解。结论:该注射用交联透明质酸钠凝胶对局部组织有轻微不良反应,但未发现全身毒性和遗传毒性影响。

Objective:To evaluate the biocompatibility of cross-linked sodium hyaluronate gel for injection.Methods:The biocompatibility of cross-linked sodium hyaluronate gel for injection was evaluated by cytotoxicity test,sensitization test,intradermal reaction test,acute toxicity test,genetic toxicity test,implantation test and chronic toxicity test.Results:The test results showed that the cross-linked sodium hyaluronate gel for injection had mild cytotoxicity,no sensitization reaction,no genetic toxicity,no acute and chronic toxic reaction,the intradermal reaction score was 1.5,and the scores of each stage in the implantation test were 3.08,1.83,0.33 and 0 at week 4,13,26 and 52,of the implantation test,the degradation was basically completed in 52 weeks.Conclusion:The crosslinked sodium hyaluronate gel for injection has mild adverse effects on local tissues,but no systemic toxicity and genotoxicity.