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目的为确定用于治疗妇女细菌性阴道炎的纳米银温敏喷雾凝胶的安全性,对其体内外毒性进行研究,为进一步研发提供依据。方法采用小鼠急性毒性上下法评价纳米银温敏喷雾凝胶的体内毒性。采用倒置显微镜观察细胞的生长状况(定性)和噻唑蓝(MTT)比色法(定量)检测不同质量浓度的纳米银温敏喷雾凝胶对小鼠成纤维细胞L-929的体外细胞毒性,并评价相对增殖率。结果纳米银温敏喷雾凝胶ig给药对小鼠半数致死量(LD50)>5.0g/kg,表明纳米银温敏喷雾凝胶的急性毒性较低。纳米银温敏喷雾凝胶质量浓度低于7.0μg/mL时,对细胞的生长无明显抑制作用,但随着剂量的加大和作用时间的延长,对细胞生长的抑制作用越来越明显,并有一定的剂量依赖趋势,同时细胞在形态学上也出现了一系列变化。结论纳米银温敏喷雾凝胶无明显毒性。
Objective To determine the safety of nanosilver temperature-sensitive spray gel for the treatment of bacterial vaginosis in women and to study its toxicity in vitro and in vivo, and to provide the basis for further research and development. Methods The in vivo toxicity of nano-silver thermo-sensitive spray gel was evaluated by acute toxicity test in mice. In vitro cytotoxicity of the nanosilver temperature-sensitive spray gel with different concentrations on the mouse fibroblast cell line L-929 was observed by inverted microscope (qualitative) and MTT assay (quantitative) Evaluation of relative proliferation rate. Results The nano-silver temperature-sensitive spray gel ig administration LD50> 5.0g / kg, indicating that the nano-silver temperature-sensitive spray gel acute toxicity is low. Nano silver temperature-sensitive spray gel mass concentration of less than 7.0μg / mL, no significant inhibitory effect on cell growth, but with the increase of dose and duration of action, the inhibition of cell growth more and more obvious, and There is a certain dose-dependent trend, while cells also appeared in a series of morphological changes. Conclusion Nano silver temperature-sensitive spray gel no obvious toxicity.