论文部分内容阅读
目的评价透明质酸修护贴敷料的生物安全性。方法本实验选取了3个不同批次的样品，参考GB/T16886-2005《医疗器械生物学评价》，进行皮肤刺激、致敏、细胞毒性三种试验方法。结果该产品对兔皮肤的原发性刺激指数为0，极轻微的反应类型，对豚鼠皮肤无致敏反应，对L-929细胞无细胞毒性反应。结论选择的试验研究方法可行，适用于透明质酸修护贴敷料的安全性评价。“,”Objective Assess biological safety of hyaluronic acid cream dressing. Methods In this experiment,3 dif erent batches of samples was selected,and refer to the GB16886-2005 biological evaluation of medical devices,its were for shin irritation、sensitization、cytotoxicity of three kinds of test methods.Results The product of rabbit shin primary irritation index was 0,and it was the reaction type and minimal.It was no al ergic reaction on guinea .It was on L-929 cel s without cytotoxicity reaction. Conclusion Methods the test research is feasible,applicable safety evaluation in hyaluronic acid cream dressing.