数字化珊瑚羟基磷灰石人工骨的致敏实验  

Sensitization test of the digital coralline hydroxyapatite artificial bone scaffold at the maximal dosage

作　　者：林山[1] 黄晓梅[2,3] 芮钢[1] 尹庆水[4] 尤元璋[1] 

机构地区：[1]厦门大学附属第一医院骨科,福建省厦门市361003 [2]漳州职业技术学院食品与生物工程系,福建省漳州市363000 [3]中国科学院城市环境研究所城市生态健康与环境安全研究中心,福建省厦门市361021 [4]解放军广州军区广州总医院全军创伤骨科中心,广东省广州市510010

出　　处：《中国组织工程研究》2014年第25期3961-3965,共5页Chinese Journal of Tissue Engineering Research

基　　金：福建省自然科学基金青年创新项目(2013D013);福建省教育厅科技项目(JA12416);漳州职业技术学院院级科研项目(ZZY1204)~~

摘　　要：背景:前期实验成功制备了数字化珊瑚羟基磷灰石人工骨支架材料,并已通过实验证实其具有骨组织工程支架材料必需的理化性能。目的:评价数字化珊瑚羟基磷灰石人工骨的致敏性。方法:将32只白化豚鼠随机分为4组,每组8只:实验组分别采用质量比为3∶1或4∶1原料制备的数字化珊瑚羟基磷灰石人工骨支架浸提液,阳性对照组采用体积分数为5%甲醛溶液,阴性对照组采用生理盐水。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24,48 h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48 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:阴性对照组和质量比为3∶1或4∶1原料制备的数字化珊瑚羟基磷灰石人工骨支架浸提液组激发阶段去除贴附物后24,48 h皮肤无致敏反应,而阳性对照组在这任一时间点均有中度以上红斑。活检皮肤光镜下实验组未见皮肤水肿,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。说明质量比为3∶1或4∶1原料制备的数字化珊瑚羟基磷灰石人工骨支架在致敏方面具有生物安全性。BACKGROUND：We have successfuly prepared digital coraline hydroxyapatite artificial bone scaffold in previous experiments, and it has been confirmed that it has the necessary physical and chemical properties of bone tissue engineering scaffolds. OBJECTIVE： To evaluate the sensitization of digital coraline hydroxyapatite artificial bone scaffold. METHODS：A total of 32 guinea pigs were randomly divided into saline group （negative control group, n=8）, 5% formaldehyde group （positive control group,n=8）, experimental A group （the mass ratio of 3：1,n=8）, and experimental B group （the mass ratio of 4：1,n=8）. Sensitization test at the maximal dosage was performedaccording toBiological Evaluation of Medical Devices-Part 10： Tests for Irritation and Delayed-Type Hypersensitivity, including intracutaneous induction, local induction, and provocation. Patch was removed after 24 and 48 hours, and the skin response was classified according to Magnusson and Kligman criteria. Patch was removed after 48 hours, and the skin was performed with biopsy, stained with hematoxylin-eosin, and observed under optical microscope. RESULTS AND CONCLUSION： Sensitization response was not tested in the negative control group, experimental A group and experimental B group at 24 and 48 hours after patch removal; however, moderate erythema was observed in the positive control group. Optical microscope demonstrated that spongiosis, edema, diffuse or perivascular mononuclear infiltration was not observed, and only a smal number of basicytes were seen in the experimental A and B groups. These findings indicate that the digital coral hydroxyapatite artificial bone scaffolds, with the mass ratio of 3：1 and 4：1, are biologicaly safe for sensitization.

关 键 词：生物材料 骨生物材料 珊瑚羟基磷灰石 左旋-聚乳酸 快速成形 骨组织工程 生物相容性 福建省自然科学基金 

分 类 号：R318[医药卫生—生物医学工程]