明胶/壳聚糖创伤敷料的生物安全性评价

Bio-safety evaluation of gelatin/chitosan wound dressing

目的:对明胶/壳聚糖敷料进行生物安全性评价.方法:进行皮肤刺激,皮肤致敏,细胞毒性和溶血实验,并按照统一的标准判定.结果:皮内注射实验:各组各点局部无红斑、水肿反应;皮肤致敏实验:试验组及空白对照组溶液家兔的致敏率为0%,而阳性对照组为100%,二者相比有显著性差异;溶血实验:除阳性对照组外,各组溶血率均在1%以内,符合规定不大于5%的标准;微核实验:材料浸提液组的微核率为1.6‰,与生理盐水对照组比较无显著性差异(P>0.05),材料浸提液组与阳性对照组(微核率为20‰)比较有显著性差异(P<0.01);细胞毒性实验:镜下见纤维细胞生长良好,形态和数量均和对照组无显著性差异,MTT法测得细胞活性和对照组无差别,细胞毒性总评级为0.结论:明胶/壳聚糖生物膜不含致热原、致敏原,无皮肤刺激反应,不引起皮肤过敏反应,无溶血反应,生物安全性保证其可望用于临床.

AIM： To evaluate the bio-safety of gelatin/chitosan wound dressing. METHODS： Cytotoxicity test, dermal stimulation test, allergic cutaneous test, hemolysis test and micronuclei test were conducted. RESULTS： In cytotoxic test, the cultured fibroblast cells were found growing steadily and the morphology was similar to that of the negative control group. No difference was observed in the cell activity between the study and control groups by MTT. The intradermic injection test found no stimulating reaction such as erythma and edema. The cutaneous allergic rate was 0 in the study group and the negative control group but the rate was 100% in the positive control group. Except for that in the positive control group, the hemolytic rate in all groups was lower than 1%, much lower than our national criteria of 5%. The micronuclei test showed that the micronucleus rate of the study group was 1.6‰, similar to that of the negative control group but was significantly different from that of the positive control group （ P 〈 0. 0001 ）. CONCLUSION： Gelatin/chitosan bio-membrane has excellent biological properties in that it contains no pyrogen and allergen and no cutaneous stimulation. Its bio-safety analysis shows a prosperous future of clinical application.