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

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.