泊洛沙姆407液体敷料的生物学评价

Evaluation of Biological Safety of Poloxamer 407 Liquid Dressing

目的评价泊洛沙姆407液体敷料的生物安全性。方法依据医疗器械生物学评价标准中的方法,对泊洛沙姆407液体敷料进行细胞毒性、皮肤刺激性和迟发型超敏反应实验,评价泊洛沙姆407液体敷料生物俺全性。结果4个梯度浓度的泊洛沙姆407液体敷料,MTT法细胞毒性试验细胞存活率82%~93%。皮肤刺激试验原发性刺激指数(PⅡ)都为0,迟发型超敏反应试验反应等级均为0级。结论泊洛沙姆407液体敷料具有良好的生物相容性,能满足医疗器械生物安全性要求。

OBJECTIVET To evaluate the biological safety of poloxamer 407 liquid dressing.METHODS According to the biological evaluation criteria of medical devices,the safety of poloxamer 407 liquid dressing were e-valuated by the cytotoxicity,shin imitation test and delayed hypersensitivity reaction,respectively.RESULTS With four gradient concentrations of poloxamer 407 liquid dressing,the cell survival rate of MTT cytotoxicity test was 82%-93%.The primary irritation index(PⅡ)of skin irritation test was 0,and the reaction grade of delayed type hypersensitivity test was 0.CONCLUSION The poloxamer 407 liquid dressing had good biological safety.