体外RhE试验应用于医疗器械皮肤刺激检测的可行性研究.pdfVIP

论 著德Thesis 范春光，刘佳，侯丽，等.体外RhE试验应用于医疗器械皮肤刺激检测的可行性研究[J]. o o 医疗卫生装备,2022,43(9)：23-27. * ZO 体外RhE试验应用于医疗器械皮肤刺激检测的 可行性研究 范春光，刘 佳，侯丽，刘成虎，李春令，汪晓飞，施燕平，刘 斌 (山东省医疗器械和药品包装检验研究院，国家药話监督管理局生物材料器械安全性评价重点实 验室，山东省医疗器械生物学评价重点实验室，济南250101) ［摘要 ］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。 ［关键词 ］体外试验;体内动物试验;RhE模型；皮肤刺激 ；医疗器械;替代试验 ［中国图书资料分类号 ］R318;R197.39 ［文献标志码 ］A ［文章编号 ］1003-8868 (2022 )09-0023-05 DOI： 10.19745/j.l003-8862022182 Feasibility study for in vitro RhE test t be used in skin irritation test of medical devices FAN Chun-guang, LIU Jia, HOU Li, LIU Cheng-hu, U Chun-ling, WANG Xiao-fei, SHI Yan-ping, LIU Bin (Shandong Institute for Medical Device and Pharmaceutical Packaging Inspection, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices, Shandong Key Laboratory of Biological Evaluation for Medical Devices, J?nan 250101, China) Abstract 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