银离子妇科修护凝胶的生物安全性评价  

Biological Safety Evaluation of Silver Ion Gynecological Repair Gel

作　　者：李晓春 王莉芳 冯润东 LI Xiao-chun;WANG Li-fang;FENG Run-dong(Shaanxi Institute for Food and Drug Control,Shaanxi Xi’an 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：《中国医疗器械信息》2020年第19期15-16,21,共3页China Medical Device Information

摘　　要：目的:对银离子妇科修护凝胶进行生物安全性评价。方法:参照GB/T16886及GB/T14233系列的要求及方法,对银离子妇科修护凝胶进行了刺激、致敏、体外细胞毒性、急性全身毒性、溶血等方面的考察。结果:在本实验室条件下,试验样品无阴道刺激性、无皮肤致敏反应、无急性全身毒性反应、无溶血反应、具1级细胞毒性。结论:银离子妇科修护凝胶生物安全性较高,有望应用于临床。Objective:To study the biological safety of the silver ion gynecological repair gel.Methods:Under the guidance of GB/T 16886 and GB/T 14233 standards,silver ion gynecological repair gel was evaluated by irritation test,sensitization test,in vitro cytotoxicity test,acute systemic toxicity test and hemolysis test.Results:The sample did not lead to vaginal irritation,sensitization,acute systemic toxicity and hemolysis,the cytotoxicity grade of the sample was 1.Conclusion:The silver ion gynecological repair gel has high biological safety and will be expected to clinical use.

关 键 词：银离子妇科修护凝胶 医疗器械 生物安全性评价 

分 类 号：R927[医药卫生—药学]