纳米银生物腹壁修复材料的生物安全性评价

Biosafety study of a nano-silver modified small intestinal submucosa mesh

目的研究自制的纳米银猪小肠黏膜下层(nano-silver modified porcine small intestinal submucosa,NS-PSIS)生物腹壁修复材料的生物安全性。方法取新鲜猪小肠,采用机械处理(去除浆膜层、黏膜层及肌层)、化学SDS法脱细胞制备猪小肠黏膜下层生物材料(porcine small intestinal submucosa,PSIS),配制50μg/mL的单体纳米银(直径15nm)溶液,将制备好的PSIS置入单体纳米银溶液中,制备成NS-PSIS,通过热原试验、皮肤刺激试验、皮内刺激试验、急性全身毒性试验及体内银吸收代谢试验对自制的纳米银生物腹壁修复材料进行生物安全性评价。结果纳米银生物腹壁修复材料无热原、皮肤刺激、皮内刺激及急性全身毒性。火焰原子吸收分光光度法显示纳米银生物腹壁修复材料不造成血液及肝、脑、肾等重要器官的银沉积。结论纳米银生物腹壁修复材料具有良好的生物安全性。

Objective To evaluate the biosafety of a nano-silver modified porcine small intestinal submucosa(NS-PSIS)mesh.Methods To prepare the porcine small intestinal submucosa(PSIS)biological materials,the mucosa and muscle layers were removed from fresh porcine small intestine by mechanical method and SDS method.50μg/mL monomer nano-silver(15nm in diameter)solution was prepared and the PSIS was exposed to the solution to prepare NS-PSIS.The biological safety of our self-made nanometer silver biological material was examined by pyrogen test,skin irritation test,skin stimulus test,acute systemic toxicity test and the metabolism of silver absorption test.Results The prepared NS-PSIS mesh was not pyrogenic and had no skin,subcutaneous irritation or systemic acute toxicity.Flame atomic absorption spectrophotometry results showed that NS-PSIS mesh caused no silver deposit in major organs such as the brain,blood,liver or kidney of SD rats.Conclusion Our nano-silver modified small intestinal submucosa mesh has satisfactory biosafety.