阴道黏膜修复敷料的生物学评价  

Biological safety evaluation of vaginal mucosa repair dressings

作　　者：李晓春 王莉芳 郑旭 徐长根 LI Xiaochun;WANG Lifang;ZHENG Xu;XU Changgen(Shanxi Institute for Food and Drug Control,Xi＇an 710065,China)

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：《中国医药科学》2018年第16期246-249,共4页China Medicine And Pharmacy

摘　　要：目的考察阴道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、刺激性试验分别对三批阴道黏膜修复敷料进行安全性评价。结果在本试验条件下,三批阴道黏膜修复敷料对豚鼠皮肤无致敏反应,细胞毒性反应级别不大于2级,具极轻度黏膜刺激。结论三批阴道黏膜修复敷料有望安全应用于临床。Objective To study the biological safety of the vaginal mucosa repair dressings. Methods The safety of three batches of vaginal mueosa repair dressings were evaluated according to the delayed-type hypersensitization test, in vitro eytotoxieity test and irritation test in the biological evaluation standard of medical devices. Results In this experiment, these three batches of vaginal mueosa repair dressings had good biological properties, there was no sensitization response to guinea pig skin and extremely mild mueosal irritation, further more the level of eytotoxieity reaction was not more than 2. Conclusion The biological safety analysis showed a prosperous future of clinical application.

关 键 词：阴道黏膜修复敷料 迟发型超敏反应 细胞毒性 刺激性 生物安全性评价 

分 类 号：R927.1[医药卫生—药学]