新型镁合金皮内刺激与致敏实验研究

Intradermal stimulus and sensitivity response for new kinds of Mg alloy

[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。

[ Objective] To evaluate the biocompatibility in vivo of Mg alloy AZ91 D （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, com- pared with normal sodium, pure magnesium and medical Ti -6A1 -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 liq- uor, it＇s kicked out. Intradermal stimulus response： normal sodium, Ti-6A1 -7Nb, AZ1, AZ3 groups inflammation respon- ded as degree I, scored 0. The others inflammation responded as degree II , scored Ⅰ. 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 -6A1 -7Nb, AZ1 , AZ3 groups inflammation responded as degree Ⅱ , erythema and edema were degree 1. The others inflammation responses were degree m, 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.