重组人皮肤表皮在医疗器械检验领域中的应用探讨

Investigation of the Feasibility of Applying Reconstructed Human Epidermis into Skin Irritation Test for Medical Devices

通过应用重组人皮肤表皮和家兔分别进行皮肤刺激试验,比较两种方法结果的一致性,来探讨重组人皮肤表皮在医疗器械检验领域中的应用。将阳性对照1%SDS、受试样品(某医用敷贴)的生理盐水、棉籽油浸提液分别作用于重组人皮肤表皮模型EpiDermTM,用MTT法测试细胞相对活性,若细胞相对活性≤50%认为具有刺激性。家兔法采用将受试物浸提液贴敷接触动物皮肤,原发性刺激指数PII>0.4认为具有刺激性。1%SDS处理的表皮的细胞相对活性为5%,受试物的生理盐水细胞相对活性72%,棉籽油浸提液细胞相对活性96%。家兔法测试1%SDS原发性刺激指数PII为5.6,受试物的生理盐水、棉籽油浸提液原发性刺激指数PII均为0.0。重组人皮肤表皮与家兔试验评价结果相一致,新型生物材料重组人皮肤表皮有望代替实验动物在医疗器械检验领域应用。

The aim of this study was to investigate if the Epi Derm TM model could be an acceptable alternative to the rabbit skin irritation test in medical device testing territory.1%SDS,certain application with saline extracts and with the sesame oil extracts were tested.Tissue viability was assessed by MTT reduction.A cell viability ≤50% was indicative of skin irritation.Cells exposed to1% SDS cell viabilities 5%.Cells exposed to saline extracts spiked with certain application exhibited cell viabilities 72%.Cells exposed to sesame oil extracts spiked with certain application exhibited cell viabilities 96%.Certain application was stick on the rabbit to get primary irritation index（PII）.PII0.4 was indicative of skin irritation.1% SDS exhibited PII 5.6,saline extracts and sesame oil extracts spiked with certain application both exhibited PII 0.0.The results of reconstructed human skin model were coincident with the rabbit skin irritation test.The results indicate that the Epi DermTM model may be a suitable in vitro replacement for the assessment of the irritation potential of medical device extracts.