Chinese Journal of Tissue Engineering Research ›› 2012, Vol. 16 ›› Issue (34): 6359-6364.doi: 10.3969/j.issn.2095-4344.2012.34.019

Previous Articles     Next Articles

Genetictoxicity of animal original biomaterials evaluated by thymidine kinase gene mutation assay

Zhang Hua1, 2, Wang Zhao-xu2, Wang Chun-ren2   

  1. 1Department of Orthopedics, the First Affiliated Hospital of Soochow University, Suzhou 215007, Jiangsu Province, China;
    2Center for Medical Devices Testing, National Institutes for Food and Drug Control, Beijing 100050, China  
  • Received:2012-02-09 Revised:2012-03-27 Online:2012-08-19 Published:2012-08-19
  • Contact: Wang Zhao-xu, Doctor, Associate researcher, Center for Medical Devices Testing, National Institutes for Food and Drug Control, Beijing 100050, China wangzx@ nicpbp.org.cn
  • About author:Zhang Hua★, Studying for master’s degree, Department of Orthopedics, the First Affiliated Hospital of Soochow University, Suzhou 215007, Jiangsu Province, China; Center for Medical Devices Testing, National Institutes for Food and Drug Control, Beijing 100050, China 781348506@qq.com

PDF

495

Abstract:

BACKGROUND: At present, a large number of medical device products originating from animals, especially those in direct contact with human body should be known about whether they conform to the clinical requirements, such as their mechanical property, biodegradable behavior, biocompatibility, cytotoxicity, genotoxicity and immunogenicity.
OBJECTIVE: To evaluate the in vitro genotoxicity of two kinds of animal original materials, and to compare the differences and similarities of thymidine kinase gene mutation affected by short and long term, as well as non-activation and activation treatments.
METHODS: According to GBT16886-12(1), the artificial biological heart valve and absorbable dura mater patch were extracted. They were consisted mainly of bovine pericardium and horse collagen respectively. L5178Y mouse lymphoma cells were treated with the two kinds of leaching liquors for 3 and 24 hours. Then, thymidine kinase gene mutation assay was performed by microplate method with line. Inoculation efficiency, relative suspension growth, relative survival, relative total growth and mutation frequency were calculated. The results of short and long term, as well as non-activation and activation, treatments were compared.
RESULTS AND CONCLUSION: After the mouse lymphoma cells were treated with the two kinds of leaching liquors for 3 and 24 hours in non-activation and activation, the results of thymidine kinase gene mutation assays showed negative. These results suggest that the two kinds of animal original materials have no mutagenic effect on L5178Y cells gene in the test of in vitro genotoxicity, which indicates that these two kinds of animal original materials have no genotoxicity and they are safe with current genotoxicity evaluation methods.

CLC Number: