Chinese Journal of Tissue Engineering Research ›› 2010, Vol. 14 ›› Issue (34): 6339-6341.doi: 10.3969/j.issn.1673-8225.2010. 34.016

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Bio-safety evaluation of a novel calcium phosphate composite with negative charge

Mao Hai-qing, Zou Jun, Zhu Xue-song, Xu Yun, Gan Min-feng, Wang Gen-lin, Yang Hui-lin   

  1. Department of Orthopaedics, First Affiliated Hospital of Soochow University, Suzhou   215006, Jiangsu Province, China
  • Online:2010-08-20 Published:2010-08-20
  • About author:Mao Hai-qing☆, Studying for doctorate, Attending physician, Department of Orthopaedics, First Affiliated Hospital of Soochow University, Suzhou 215006, Jiangsu Province, China zjszspine@126.com
  • Supported by:

    Graduate Research and Innovation Project of Jiangsu Province, No. CX09B_038Z*

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Abstract:

BACKGROUND: Since 1980s, a bone graft for repair and placement with good biocompatibility and osteoinductivity is hot spot in the field of materials and orthopaedics.

OBJECTIVE: To evaluate the bio-safety of a novel calcium phosphate composite material with negative charge.
METHODS: According to the biological test recommended by International Organization for Standardization, the erythrocyte haemolysis test, systemic toxicity test, pyrogenic test and sensitization test were performed.
RESULTS AND CONCLUSION: The rate of haemolysis was 0.24%, which was obviously lower than the positive standard, it was indicated that the in vivo transplantation of the materials could not cause the hemolytic reaction of the body. Systemic toxicity test results showed it was non-toxic, cannot change liver and kidney function indices, indicating the material is not toxic. In the pyrogenic reaction, the body temperature of the rabbits averagely increased by 0.2 ℃, which accorded with the demands of medical materials, it was indicated that the material has no pyrogenic effect. The rate of sensitization was 0, which had no significant difference from negative control, suggesting that the material has no sensitization. This novel calcium phosphate composite material with negative charge has a good bio-safety.

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