镁铝合金最大剂量的致敏试验

Sensitization test of magnalium at the maximal dosage

背景:镁合金作为潜在的新型医用可降解生物金属材料受到越来越多的关注,作为植入物需与人体具有良好的生物相容性。目的:评价镁铝合金(AZ31B)的致敏性。方法:白化豚鼠35只,随机分为生理盐水阴性对照组10只和体积分数为5%甲醛阳性对照组10只,镁铝合金浸提液组15只。根据《GB-T16886.10-2005医疗器械生物学评价第10部分刺激与迟发型超敏反应试验》最大剂量致敏试验步骤进行皮内诱导、局部诱导和激发。激发阶段去除贴附物后6,24,48,72h的豚鼠皮肤反应按Magnusson和Kligman等级进行分级。激发阶段去除贴附物后72h后对皮肤进行活检,行苏木精-伊红染色和光镜下观察。结果与结论:生理盐水阴性对照组和镁铝合金浸提液组激发阶段去除贴附物后24,48,72h皮肤无致敏反应,而甲醛阳性对照组在这任一时间点均有中度以上红斑。活检皮肤光镜下镁铝合金浸提液组未见皮肤水肿,皮肤棘细胞层水肿,血管周围、弥漫的真皮和表皮单核细胞浸润,见散在少量的嗜碱性细胞。结果提示镁铝合金浸提液在致敏方面具有生物安全性。

BACKGROUND：Magnalium which is potential to be the medical biodegraded metal implant is more and more interesting,but it must be well biocompatibility to human body.OBJECTIVE：To evaluate the sensitization of magnalium（AZ31B）.METHODS：A total of 35 guinea pigs were randomly divided into saline group（negative control group,n=10）,5%volume of formaldehyde（positive control group,n=10）,and AZ31B group（n=15）.Sensitization test at the maximal dosage was performed according to＂Biological evaluation of medical devices-Part 10：Tests for irritation and delayed-type hypersensitivity＂,including intracutaneous induction,local induction,and provocation.Patch was removed after 6,24,48,and 72 hours,and the skin response was classified according to Magnusson and Kligman criteria.Patch was removed after 72 hours,and skin was performed with biopsy,stained with HE staining,and observed under optic microscope.RESULTS AND CONCLUSION：Sensitization response was not tested in both negative control group and AZ31B group at 24,48,and 72 hours after patch removal;however,moderate erythema was observed in the positive control group.Optic microscope demonstrated that criteria of allergy such as spongiosis,edema,and diffuse as well as perivascular mononuclear infiltration was not observed in the AZ31B group,but a few basophilic cells were observed.This suggested that AZ31B was biologically safe for sensitization.