体外RhE试验应用于医疗器械皮肤刺激检测的可行性研究

Feasibility study for in vitro RhE test to be used in skin irritation test of medical devices

目的:探讨体外重建人表皮(reconstructed human epidermis,RhE)试验应用于医疗器械皮肤刺激检测的可行性。方法:制备水胶体敷料极性和非极性试验液以及体积分数为4%和1.5%的乳酸溶液作为试验样品,采用体外RhE试验和体内动物(新西兰白兔)试验检测试验样品的皮肤刺激性,并比较2种试验的结果。结果:体外RhE试验显示,水胶体敷料极性和非极性试验液及1.5%的乳酸溶液的皮肤刺激性均为阴性,而4%的乳酸溶液的皮肤刺激性为阳性;体内动物试验显示,各试验样品的皮肤刺激性均为阴性。结论:体外RhE试验比体内动物试验更加灵敏、客观,可应用于医疗器械皮肤刺激检测。

Objective To explore the feasibility of in vitro RhE test to be used to detect the skin irritation of medical devices.Methods Polar and non-polar test solutions of hydrocolloid dressing lactic acid solutions with volume fractions of 4%and 1.5%were prepared as test samples.The skin irritation of the test samples was examined using in vitro RhE test and in vivo animal(New Zealand white rabbit)test,and the results of the 2 tests were compared.Results In vitro RhE tests showed negative skin irritation for both polar and non-polar test solutions of hydrocolloid dressing and 1.5%lactic acid solution,while 4%lactic acid solution showed positive skin irritation;in vivo animal tests found negative skin irritation for all the test samples.Conclusion In vitro RhE test gains advantages over in vivo animal test in sensitivity and objectiveness when used to detect the skin irritation of medical devices.