医用透明质酸钠修复贴的生物学试验  

Biological Tests of Medical Sodium Hyaluronate Repair Paste

作　　者：王宗尉 肖佳音 李庆忠 

机构地区：[1]黑龙江省食品药品检验检测所,黑龙江哈尔滨150001

出　　处：《哈尔滨医药》2016年第2期142-143,共2页Harbin Medical Journal

摘　　要：目的观察医用透明质酸钠修复贴对实验动物的皮肤致敏反应、皮肤刺激反应和细胞毒性反应,为其作为医疗器械用途的生物安全性评价提供科学依据。方法根据该产品与人体接触方式及接触时间,按照医疗器械生物学评价标准选择皮肤致敏试验,皮肤刺激试验,细胞毒性试验进行生物安全性评价。结果未出现皮肤致敏反应及皮肤刺激反应,无细胞毒性。结论医用透明质酸钠修复贴临床用于缓解和补偿损伤使用是安全的。Objective Observing medical sodium hyaluronate repair paste on experimental animal skin sensitization,skin irritation and cytotoxicity,providing scientific basis to evaluate the biological safety of medical uses as its. Methods On the basis of the product and the human body contact and contact time,according to the standards of biological evaluation of medical devices of skin sensitization test,skin irritation test,evaluate the bio safety of cell toxicity test. Results No skin sensitization and skin irritation,no cell toxicity. Conclusion medical sodium hyaluronate repair with clinical for mitigation and compensation injury is safe to use.

关 键 词：医用透明质酸钠修复贴 医疗器械 生物安全性评价 

分 类 号：R986[医药卫生—药品]