目的 為確定用于治療婦女細(xì)菌性陰道炎的納米銀溫敏噴霧凝膠的安全性，對(duì)其體內(nèi)外毒性進(jìn)行研究，為進(jìn)一步研發(fā)提供依據(jù)。方法 采用小鼠急性毒性上下法評(píng)價(jià)納米銀溫敏噴霧凝膠的體內(nèi)毒性。采用倒置顯微鏡觀察細(xì)胞的生長(zhǎng)狀況（定性）和噻唑藍(lán)（MTT）比色法（定量）檢測(cè)不同質(zhì)量濃度的納米銀溫敏噴霧凝膠對(duì)小鼠成纖維細(xì)胞L-929的體外細(xì)胞毒性，并評(píng)價(jià)相對(duì)增殖率。結(jié)果 納米銀溫敏噴霧凝膠ig給藥對(duì)小鼠半數(shù)致死量（LD₅₀）＞5.0 g/kg，表明納米銀溫敏噴霧凝膠的急性毒性較低。納米銀溫敏噴霧凝膠質(zhì)量濃度低于7.0 μg/mL時(shí)，對(duì)細(xì)胞的生長(zhǎng)無(wú)明顯抑制作用，但隨著劑量的加大和作用時(shí)間的延長(zhǎng)，對(duì)細(xì)胞生長(zhǎng)的抑制作用越來(lái)越明顯，并有一定的劑量依賴趨勢(shì)，同時(shí)細(xì)胞在形態(tài)學(xué)上也出現(xiàn)了一系列變化。結(jié)論 納米銀溫敏噴霧凝膠無(wú)明顯毒性。

_Objective To evaluate the toxicity of temperature-sensitive spray gel containing silver nanoparticles which was used for the treatment of women bacterial vaginosis. _Methods The acute toxicity study was conducted using main test of up-and-down procedure. The cytotoxicity of this agent on rat’s fibroblast L-929 cells was examined with MTT method. MTT assay was performed to observe the toxicity of temperature-sensitive spray gel containing silver nanoparticles in different dose levels and to evaluate the cell proliferation. The morphologic changes of the cells were observed by inverted microscope. _Results The study demonstrated that LD₅₀ value was above 5 000 mg/kg, which showed low acute toxicity of this gel. No significant inhibitive effect on the growth of L-929 cells was observed from inverted microscopy when the concentration of gel was less than 7.0 μg/mL. With increasing dose levels of temperature-sensitive spray gel containing silver nanoparticles and longer interaction time between this agent and L-929 cells, the inhibitive effect on the growth of L-929 cells was increased and showed the tendency of dose dependent. Meanwhile, the morphologic changes of the cells were significant. _Conclusion No significant toxicity in vivo and in vitro is found in temperature-sensitive spray gel containing silver nanoparticles.

廣東省科技計(jì)劃項(xiàng)目（2007B03070400）