Biocompatibility and security of calcium sulfate bone substitutes

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

doi:10.3969/j.issn.2095-4344.2016.16.005

Abstract：BACKGROUND:It is a great potential study that calcium sulfate product loaded with antibiotics is developed, but this product is not systematicaly studied and its biocompatibility and security need to be further studied. <br> OBJECTIVE:To evaluate the biocompatibility and safety of vancomycin- or gentamicin-loaded calcium sulfate bone. <br> METHODS: (1) Hemolysis test: vancomycin-loaded, gentamicin-loaded calcium sulfate extracts, double distiled 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 intraperitonealy injected to mice, respectively. (3) Acute toxicity test: vancomycin-loaded and gentamicin-loaded calcium sulfate extracts, and normal saline solution were intraperitonealy injected to mice, respectively. (4) Pyrogen test: the mice were injected vancomycin-loaded and gentamicin-loaded calcium sulfate extractsvia 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. <br> 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.