中国组织工程研究 ›› 2016, Vol. 20 ›› Issue (16): 2317-2323.doi: 10.3969/j.issn.2095-4344.2016.16.005

• 组织工程骨及软骨材料 tissue-engineered bone and cartilage materials • 上一篇    下一篇

骨内置入硫酸钙产品的生物相容性与安全性评价

邱奕雁,陈  扬,周文钰,夏晓龙,杨欣建   

  1. 深圳市第二人民医院脊柱外科,广东省深圳市  518035
  • 收稿日期:2016-03-13 出版日期:2016-04-15 发布日期:2016-04-15
  • 通讯作者: 杨欣建,主任医师,深圳市第二人民医院脊柱外科,广东省深圳市 518035
  • 作者简介:邱奕雁,男,1983年生,广东省汕头市人,汉族,博士,主治医师,主要从事脊柱基础及临床研究。
  • 基金资助:

    2014年建设中医药强省立项资助项目(20141257):中药牛淫合剂干预骨代谢与骨密度的研究

Biocompatibility and security of calcium sulfate bone substitutes

Qiu Yi-yan, Chen Yang, Zhou Wen-yu, Xia Xiao-long, Yang Xin-jian   

  1. Department of Spinal Surgery, Shenzhen Second People’s Hospital, Shenzhen 518035, Guangdong Province, China
  • Received:2016-03-13 Online:2016-04-15 Published:2016-04-15
  • Contact: Yang Xin-jian, Chief physician, Department of Spinal Surgery, Shenzhen Second People’s Hospital, Shenzhen 518035, Guangdong Province, China
  • About author:Qiu Yi-yan, M.D., Attending physician, Department of Spinal Surgery, Shenzhen Second People’s Hospital, Shenzhen 518035, Guangdong Province, China
  • Supported by:

    the Provincial-Level Funding Project for Strengthening the Development of Traditional Chinese Medicine in 2014, No. 20141257

摘要:

文章快速阅读:

 

文题释义:
硫酸钙产品:硫酸钙产品是一种重要的骨修复替代材料,具有良好的成骨性能与骨诱导活性。然而,目前常见的α-半水硫酸钙晶体等硫酸钙材料存在延迟愈合及难以彻底治愈等弊端。为此,有必要探索新的硫酸钙产品,以控制感染,彻底治愈骨缺损修复。把硫酸钙当作药物缓释载体制备的硫酸钙产品,是当前临床重要的研究方向。其中,将硫酸钙材料当作载体,载入抗生素是制备硫酸钙产品的一个新方向,但此类产品在当前尚没有获得系统的研究,其生物相容性与安全性还需要作深入探究。
生物相容性:指材料在机体的特定部位引起恰当的反应。根据国际标准化组织(International Standards Organization,ISO)会议的解释,是指生命体组织对非活性材料产生反应的一种性能,一般是指材料与宿主之间的相容性。
背景:在硫酸钙材料中载入抗生素是制备硫酸钙产品的一个新方向,但此类产品在当前尚没有获得系统的研究,其生物相容性与安全性还需要作深入探究。
目的:分析载万古霉素硫酸钙、载庆大霉素硫酸钙骨内置入硫酸钙产品的生物相容性,并评价其安全性。
方法:①溶血实验:在兔抗凝血中分别加入载万古霉素硫酸钙浸提液、载庆大霉素硫酸钙浸提液、双蒸水及生理盐水。②微核实验:在小鼠腹腔内分别注射载万古霉素硫酸钙浸提液、载庆大霉素硫酸钙浸提液、环磷酰胺与生理盐水。③急性毒性实验:在小鼠腹腔内分别注射载万古霉素硫酸钙浸提液、载庆大霉素硫酸钙浸提液与生理盐水。④热原实验:通过小鼠耳缘静脉分别注射载万古霉素硫酸钙浸提液、载庆大霉素硫酸钙浸提液。⑤皮内刺激实验:分别在兔的脊柱一侧注射载万古霉素硫酸钙浸提液、载庆大霉素硫酸钙浸提液。⑥肌内埋置实验:分别在兔背部肌肉内置入载万古霉素硫酸钙与载庆大霉素硫酸钙。⑦骨内埋置实验:分别在兔股骨缺损处植入载万古霉素硫酸钙与载庆大霉素硫酸钙。
结果与结论:两种硫酸钙产品无溶血反应、遗传毒性反应、急性毒性反应、热原反应与皮内刺激反应,具有良好生物相容性与安全性。
中国组织工程研究杂志出版内容重点:生物材料;骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性;组织工程
ORCID: 0000-0003-4708-9906(杨欣建)

关键词: 生物材料, 骨生物材料, 载万古霉素硫酸钙, 载庆大霉素硫酸钙, 生物相容性, 安全性, 骨内植入物

Abstract:

BACKGROUND: It is a great potential study that calcium sulfate product loaded with antibiotics is developed, but this product is not systematically studied and its biocompatibility and security need to be further studied.

OBJECTIVE: To evaluate the biocompatibility and safety of vancomycin- or gentamicin-loaded calcium sulfate bone.
METHODS: (1) Hemolysis test: vancomycin-loaded, gentamicin-loaded calcium sulfate extracts, double distilled water and saline were added into rabbit anticoagulant blood samples. (2) Micronucleus test: vancomycin-loaded and gentamicin-loaded calcium sulfate extracts, cyclophosphamide and normal saline solution were intraperitoneally injected to mice, respectively. (3) Acute toxicity test: vancomycin-loaded and gentamicin-loaded calcium sulfate extracts, and normal saline solution were intraperitoneally injected to mice, respectively. (4) Pyrogen test: the mice were injected vancomycin-loaded and gentamicin-loaded calcium sulfate extracts via the ear vein. (5) Intradermal stimulation test: vancomycin-loaded and gentamicin-loaded calcium sulfate extracts were respectively injected into the unilateral spine of rabbits, respectively. (6) Intramuscular implantation test: vancomycin-loaded and gentamicin-loaded calcium sulfate extracts were respectively injected to the dorsal muscle of rabbits. (7) Intraosseous implantation test: vancomycin-loaded and gentamicin-loaded calcium sulfate were implanted into the necrotic femoral bone of rabbits.
RESULTS AND CONCLUSION: Both vancomycin-loaded and gentamicin-loaded calcium sulfate products, which have no hemolytic reaction, genetic toxicity, acute toxicity, pyrogen reaction and skin irritation, are considered to have good biocompatibility and safety.
中国组织工程研究杂志出版内容重点:生物材料;骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性;组织工程

Key words: Calcium Sulfate, Materials Testing, Vancomycin, Tissue Engineering