中国组织工程研究

中国组织工程研究 ›› 2010, Vol. 14 ›› Issue (16): 2899-2902.doi: 10.3969/j.issn.1673-8225.2010.16.013

• 材料生物相容性 material biocompatibility • 上一篇    下一篇

镁铝合金最大剂量的致敏试验

陈旭琼1，尹庆水1，张  余1，夏  虹1，张  涛1，杨  柯2，张炳春2，谭丽丽2，林  山1   

  1. 1解放军广州军区广州总医院骨科医院，广东省广州市  510010；2中国科学院金属研究所，辽宁省沈阳市 110016
  • 出版日期:2010-04-16 发布日期:2010-04-16
  • 通讯作者: 尹庆水，教授，主任医师，博士生导师，解放军广州军区广州总医院骨科医院，广东省广州市 510010 gz_yqs@126.com
  • 作者简介:陈旭琼☆，男，1978年生，广东省潮阳市人，汉族，南方医科大学在读博士，主治医师，主要从事医用可降解镁合金植入物方面的研究。 cxq_gk@126.com
  • 基金资助:

    国家自然科学基金项目(30872642)，课题名称：镁合金-羟基磷灰石涂层接骨板的降解规律及生物力学研究。

Sensitization test of magnalium at the maximal dosage

Chen Xu-qiong1, Yin Qing-shui1, Zhang Yu1, Xia Hong1, Zhang Tao1, Yang Ke2, Zhang Bing-chun2, Tan Li-li2, Lin Shan1   

  1. 1 Department of Orthopaedics, Guangzhou General Hospital of Guangzhou Military Area Command of Chinese PLA, Guangzhou   510010, Guangdong Province, China; 2 Institute of Metal Research, Chinese Academy of Sciences, Shenyang   110016, Liaoning Province, China
  • Online:2010-04-16 Published:2010-04-16
  • Contact: Yin Qing-shui, Professor, Chief physician, Doctoral supervisor, Department of Orthopaedics, Guangzhou General Hospital of Guangzhou Military Area Command of Chinese PLA, Guangzhou 510010, Guangdong Province, China gz_yqs@126.com
  • About author:Chen Xu-qiong☆, Studying for doctorate, Attending physician, Department of Orthopaedics, Guangzhou General Hospital of Guangzhou Military Area Command of Chinese PLA, Guangzhou 510010, Guangdong Province, China cxq_gk@126.com
  • Supported by:

    the National Natural Science Foundation of China, No. 30872642*

PDF

706

被引次数

24

摘要：

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-T 16886.10-2005 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6，24，48，72 h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72 h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24，48，72 h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。

关键词: 镁铝合金, 致敏, 豚鼠, 生物相容性, 可降解材料

Abstract:

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.

中图分类号: