Chinese Journal of Tissue Engineering Research ›› 2016, Vol. 20 ›› Issue (16): 2317-2323.doi: 10.3969/j.issn.2095-4344.2016.16.005

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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

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