防逆流纳米Ag-CHA-SiO_2抗菌型导尿管体外生物安全性研究
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摘要
目的:研究防逆流纳米Ag-CHA-SiO_2抗菌型导尿管(简称"抗菌型导尿管")的体外生物安全性,为后期的产品开发提供实验依据。方法:依据GB/T 16886.5—2017《医疗器械生物学评价第5部分:体外细胞毒性试验》进行细胞形态观察与MTT试验以评判抗菌型导尿管细胞毒性,0级和1级判定为无毒性材料;依据WS/T 367—2012《医疗机构消毒技术规范》中的抑菌环操作规范进行抑菌环试验以评价抗菌型导尿管的抑菌性能,抑菌环直径≥7 mm时即判定具有抑菌、抗菌作用。结果:根据细胞形态观察与MTT试验结果,抗菌型导尿管细胞毒性分级为1级,为无毒性材料;抗菌型导尿管对大肠杆菌和金黄色葡萄球菌的抑菌圈直径分别为(11.24±0.54)、(7.63±0.34)mm,均≥7 mm,具有抑菌、抗菌性能。结论:防逆流纳米Ag-CHA-SiO_2抗菌型导尿管无细胞毒性、抑菌性能良好,体外生物安全性能符合要求,是良好的升级换代产品,值得深入研究并推广。
Objective To study the biosafety in vitro of antireflux nano Ag-CHA-SiO_2 antibacterial catheters, and to provide experimental basis for product development in the later stage. Methods Cell morphology observation and MTT assay were executed to determine the cytotoxicity of the catheter according to GB/T 16886.5—2017 Biological evaluation of medical devices-Part 5: Test for in vitro cytotoxicity, and Class 0 and 1 were regarded as nontoxic materials. Inhibition ring test was carried out to evaluate the bacteriostatic activity of the catheter according to WS/T 367—2012 Regulation of disinfection technique in healthcare settings, and the catheter was considered being bacteriostatic in case the inhibition ring had a diameter not less than 7 mm. Results Cell morphology observation and MTT assay showed the catheter was graded as Class 1 cytotoxicity, that is, the catheter was nontoxic. The inhibition ring diameters was(11.24 ±0.54)mm for escherichia coli and(7.63 ±0.34)mm for staphylococcus aureus, so the catheter proved to gain bacteriostatic activity. Conclusion The antireflux Ag-CHA-SiO_2 antibacterial catheter behaves well in cytotoxicity, bacteriostatic activity, biosafety in vitro, and thus is worthy promoting practically.
Objective To study the biosafety in vitro of antireflux nano Ag-CHA-SiO_2 antibacterial catheters, and to provide experimental basis for product development in the later stage. Methods Cell morphology observation and MTT assay were executed to determine the cytotoxicity of the catheter according to GB/T 16886.5—2017 Biological evaluation of medical devices-Part 5: Test for in vitro cytotoxicity, and Class 0 and 1 were regarded as nontoxic materials. Inhibition ring test was carried out to evaluate the bacteriostatic activity of the catheter according to WS/T 367—2012 Regulation of disinfection technique in healthcare settings, and the catheter was considered being bacteriostatic in case the inhibition ring had a diameter not less than 7 mm. Results Cell morphology observation and MTT assay showed the catheter was graded as Class 1 cytotoxicity, that is, the catheter was nontoxic. The inhibition ring diameters was(11.24 ±0.54)mm for escherichia coli and(7.63 ±0.34)mm for staphylococcus aureus, so the catheter proved to gain bacteriostatic activity. Conclusion The antireflux Ag-CHA-SiO_2 antibacterial catheter behaves well in cytotoxicity, bacteriostatic activity, biosafety in vitro, and thus is worthy promoting practically.
引文
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[11]骆安德,苏美如,梁琼.导尿管相关尿路感染标准操作规程的临床应用效果[J].中华医院感染学杂志,2011,21(2):311-313.
[12]朱文波,戴蕾,张葵.尿白细胞、细菌及亚硝酸盐的联合检测在诊断尿路感染中的应用[J].医疗卫生装备,2016,37(5):78-80.
[13]桂建军,曹敏,王军,等.国内外应急救援卫生装备现状与发展探讨[J].医疗卫生装备,2016,37(11):126-128.
[2]王嘉沪,刘晓莉,龚会军,等.导尿管所致尿路感染的菌群分布及耐药分析[J].中国基层医药,2005,12(12):1 764-1 765.
[3]医疗器械生物学评价第5部分:体外细胞毒性试验:GB/T16886.5—2017[S].
[4]戴建国,李超,黄培林.高密度壳聚糖对L-929细胞的毒性研究[J].东南大学学报(医学版),2008,27(1):54-57.
[5]田小俊,田胜慧,郑保婷,等.探讨医用胶细胞毒性试验方法的选择[J].中国医疗器械信息,2017,23(11):58-60.
[6]医疗机构消毒技术规范:WS/T 367—2012[S].
[7]刘如运.几种常见抑菌试验方法的评价与比较[J].现代企业教育,2013(7下):341-342.
[8]王娣,许晖,钱时权,等.畅麝香草酚对食品常见污染菌的抑菌作用[J].食品科学,2013,34(3):119-122.
[9]李聪慧,王志刚.粘接树脂材料细胞毒性的体外评价[J].河南医学研究,2018,27(2):194-197.
[10]翟军红,郭云童,刘军,等.纳米Ag-SiO2导尿管的细胞毒性评价[J].中国组织工程研究与临床康复,2011,15(29):5 371-5 374.
[11]骆安德,苏美如,梁琼.导尿管相关尿路感染标准操作规程的临床应用效果[J].中华医院感染学杂志,2011,21(2):311-313.
[12]朱文波,戴蕾,张葵.尿白细胞、细菌及亚硝酸盐的联合检测在诊断尿路感染中的应用[J].医疗卫生装备,2016,37(5):78-80.
[13]桂建军,曹敏,王军,等.国内外应急救援卫生装备现状与发展探讨[J].医疗卫生装备,2016,37(11):126-128.