鼻腔黏膜修复敷料的生物学评价  

Biological Evaluation of Nasal Mucosa Repair Dressings

作　　者：李晓春 王莉芳 郑旭 徐长根 Li Xiaochun;Wang Lifang;Zheng Xu;Xu Changgen(Shaanxi Institute for Food and Drug Control,Xi＇ an,Shaanxi,China 710065)

机构地区：[1]陕西省食品药品监督检验研究院,陕西西安710065

出　　处：《中国药业》2018年第17期10-13,共4页China Pharmaceuticals

摘　　要：目的考察鼻腔黏膜修复敷料的生物安全性。方法按照医疗器械生物学评价标准中的迟发型超敏反应试验、体外细胞毒性试验、刺激性试验分别对3个厂家的鼻腔黏膜修复敷料进行安全性评价。结果 3批鼻腔黏膜修复敷料的安全性检查结果均符合规定。结论 3批鼻腔黏膜修复敷料安全、可用。Objective To investigate the biological safety of the nasal mucosa repair dressings. Methods According to the standard ofmedical devices biological evaluation, 3 batches of nasal mucosa repair dressings from different manufacturers were tested by delayed - typehypersensitization test, f vitro cytotoxicity test and hritation test. Results The results of safety tests of the 3 batches repair dressings were in accordance with the standards. Conclusion The 3 batches of nasal mucosa repair dressings were safe and feasible.

关 键 词：鼻腔黏膜 修复敷料 医疗器械 生物安全性评价 

分 类 号：R965.3[医药卫生—药理学] R765.25[医药卫生—药学]