Chinese Journal of Tissue Engineering Research ›› 2016, Vol. 20 ›› Issue (38): 5650-5656.doi: 10.3969/j.issn.2095-4344.2016.38.004

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Biological safety of silk fibroin/nano-hydroxyapatite composites

Fan Chun-quan1, Ye Xiao-jian2 
  

  1. 1Orthopedics Center of PLA, the 175th Hospital of PLA/Dongnan Hospital of Xiamen University, Zhangzhou 363000, Fujian Province, China; 2Department of Orthopedics, Changzheng Hospital, Second Military Medical University, Shanghai 200001, China
  • Received:2016-07-05 Online:2016-09-16 Published:2016-09-16
  • Contact: Ye Xiao-jian, M.D., Chief physician, Professor, Doctoral supervisor, Department of Orthopedics, Changzheng Hospital, Second Military Medical University, Shanghai 200001, China
  • About author:Fan Chun-quan, M.D., Attending physician, Orthopedics Center of PLA, the 175th Hospital of PLA/Dongnan Hospital of Xiamen University, Zhangzhou 363000, Fujian Province, China
  • Supported by:
    the National Natural Science Foundation of China, No. 81472071; the Medical Incubation Program for the Youth in PLA, No. 15QNP022; the Medical Innovation Project of the Nanjing Military Region of Chinese PLA, No. 15MS109

Abstract:

BACKGROUND: Silk fibroin has excellent biocompatibility, biodegradability and unique mechanical properties. Its composite, silk fibroin/nano-hydroxyapatite, can simulate the composition and structure of nature bone tissue, contributing to remedying the insufficient mechanical properties of nano-hydroxyapatites.
OBJECTIVE: To observe the biological safety of silk fibroin/nano-hydroxyapatite composites.
METHODS: Silk fibroin/nano-hydroxyapetite composite biomaterial was synthesized by the coprecipitation method using silk fibroin, calcium chloride and diammonium phosphate as raw materials. According to the demands of International Standard Organization (ISO10993) and Technical Evaluation Standards of Biomedical Materials and Medical Instruments promulgated by Chinese Board of Health (GB/T 16886), experiments of cell toxicity in vitro, acute toxicity and hemolysis were investigated to evaluate the biocompatibility of silk fibroin/nano-hydroxyapetite composite.
RESULTS AND CONCLUSION: L929 cells co-cultured with silk fibroin/nano-hydroxyapatite composite leaching liquor had good cell morphology, metabolism and proliferation. The leaching extract of silk fibroin/nano-hydroxyapatite composite injected into mice intraperitoneally had no significant adverse reactions. And silk fibroin/nano-hydroxyapatite composite extracts caused 2.39% blood hemolysis, less than the international standards 5%. These experimental results on cell toxicity test in vitro, acute toxicity and hemolysis met the demands of ISO10993 and GB/T, which show the biological safety of the silk fibroin/nano-hydroxyapatite composite for clinical application.

Key words: Silk, Nanocomposites, Hydroxyapatites, Tissue Engineering

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