新型镁合金皮内刺激与致敏实验研究.DOCVIP

临床医学论文-新型镁合金皮内刺激与致敏实验研究 ??????????????????? 作者：王飞，王钢　孟祥翔，张永君，张大保 【摘要】? [目的]通过动物皮内刺激及致敏试验，对镁合金AZ91D(AZ0)、Mg-Mn-Ce(RE0)及其在三种不同阶跃式阳极氧化表面改性条件下所得新型镁合金(AZ1、AZ2、AZ3、RE1、RE2、RE3)的体内生物相容性进行初步的评价。[方法]按照GB/T16886.10-1997《医疗器械生物学评价》刺激与致敏试验方法进行。采用与生理盐水、高纯镁及医用钛合金Ti-6A1-7Nb对照的研究方法，将镁合金浸提液注入豚鼠皮肤内观察皮内反应：采取皮内注射和涂皮相结合的诱导法观察豚鼠致敏反应。[结果]RE2由于成膜效果较差，无法制备浸提液，剔除出试验组。皮内刺激试验：生理盐水组、Ti-6Al-7Nb、AZ1、AZ3炎性反应I级，评分0分;其余试样皮内刺激反应稍重，有少许充血水肿(Ⅱ级)，评分1分。致敏试验：甲醛组炎症反应重(Ⅳ级)，肉眼观局部皮肤坏死结痂，致敏4级;生理盐水组无明显炎症反应(Ⅰ级)，致敏0级;Ti-6Al-7Nb、AZ1、AZ3炎症反应Ⅱ级，红斑及水肿轻微(Ⅰ级);余试验组炎症反应Ⅲ级，致敏2级。[结论]由以上结果可以初步认为，新型镁合金AZ1、AZ3在皮内刺激及致敏试验中表现较好，具备良好的生物相容性，有望成为新一代的骨科植入材料。 【关键词】? 镁合金; 刺激; 致敏; 生物材料; 阶跃式阳极氧化 　　Abstract: [Objective]To evaluate the biocompatibility in vivo of Mg alloy AZ91D(AZ0),Mg-Mn-Ce (RE0) and their step anodizational materials (AZ1, AZ2, AZ3, RE1, RE2,RE3) by the experiments of intradermal stimulus and sensitivity response. [Methods]According toGB/T 16886.10-1997 Biological Evaluation of Medical Apparatus and Instrument, compared with normal sodium, pure magnesium and medical Ti-6Al-7Nb, the leaching liquor were injected into cutis to evaluate stimulus response，to evaluate sensitivity response by injection and illinition.[Results]RE2 could not prepare leaching liquor, it’s kicked out. Intradermal stimulus response:normal sodium,Ti-6A1-7Nb, AZ1,AZ3 groups inflammation responded as degree I, scored 0. The others inflammation responded as degree Ⅱ, scored 1. Sensitivity response: formaldehyde group inflammation responded as degree IV, erythema and edema were degree IV. Normal sodium group inflammation responded as degree I, erythema and edema were degree 0. Ti-6Al-7Nb, AZ1,AZ3 groups inflammation responded as degree Ⅱ, erythema and edema were degree 1. The others inflammation responses were degree Ⅲ, erythema and edema were degree Ⅱ.[Conclusion]The new kinds of magnesium alloy AZ1, AZ3 possesses good preliminary biocompatibility in vivo, so it is very possible to be a new type of bone surgery implant material. 　　Key words：Mg alloy;