医用交联透明质酸钠凝胶的细胞毒性试验是用细胞培养方.doc

医用交联透明质酸钠凝胶的细胞毒性试验是用细胞培养方法进行毒理学风险评价该研究是按国际标准化组织ISO10993-5《医疗器械生物学评价第5部分：体外细胞毒性试验》的规定进行的试验样品置于细胞培养液中侵提将试验样品的提取液分别放于至少3个培养着L-929小鼠纤维细胞的细胞培养板孔内，该细胞是在37°C且含5%二氧化碳气体的空气中进行培养而成的同时将阴性对照样品和阳性对照样品的提取液都分别置于三个培养着小鼠纤维细胞的细胞培养板孔内将所有这些细胞在含5%二氧化碳气体的空气中、于37°C下培养72小时在72小时±2小时内，对试验样品组、阴性对照样品组、阳性对照样品组及空白对照试剂组的细胞进行显微检查，确定细胞的毒性反应The cytotoxicity test for Medical Cross-linked Sodium Hyaluronate Gel is to conduct a toxicological risk assessment by using cell culture method. This study was performed in compliance with the requirements of ISO10993-5 -Biological evaluation of medical devices－－part5: Tests for cytotoxicity. The test articles were extracted in cell culture fluid. The test article extracts were respectively put into at least 3 cells of culture plate where L-929 mouse fibroblasts were cultured and these cells were incubated at 37°C in an atmosphere containing 5% carbon dioxide. At the same time, both the negative control article and the positive control article extract were respectively put into 3 wells of cell culture plate where L-929 mouse fibroblast was cultured. All of these cells were incubated at 37°C in an atmosphere containing 5% carbon dioxide for 72 hours. Within 72±2 hours, the cells in the test article group, the negative test control group, the positive test control group and the blank control group were examined a microscope to confirm the cell toxicity.。