›› 2012, Vol. 24 ›› Issue (5): 359-361.doi: 10.3969/j.issn.1004-616x.2012.05.009

• 论著 • Previous Articles     Next Articles

Study of the genotoxicity of the bio-degradable polyglycolide fiber materials

HAN Qian-qian;HUANG Wei;SONG Yi-ping;WANG Zhao-xu;LI Yan-hong;WANG Chun-ren;HUANG Qing-quan   

  1. (1. National Institute for Food and Drug Control, Center of Medical Devices, Beijing 100050; 2. Beijing Stomatological Hospital, Emergency Department, Beijing 100050, China)
  • Received:2012-05-15 Revised:2012-07-19 Online:2012-09-30 Published:2012-09-30
  • Contact: HAN Qian-qian

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Abstract: OBJECTIVE: To investigate the genetic toxicity of bio-degradable polyglycolic acid (PGA) fiber materials and to assess its safety. METHODS：The bacterial reverse mutation study (Ames test) and the mouse lymphoma assay ( MLA) were used to test the potential genotoxicity. RESULTS： In Ames test，the bio-degradable PGA fiber material extract did not increase the revertant colonies (P＞0.5). From the mouse lymphoma assay，there was no significant difference of the clone forming rate between the PGA fiber extract group and the negative control group (P＞0.5)，however there was a significant difference between the PGA group and positive control group(P＜0.05). CONCLUSION：The bio-degradable PGA fiber material was not mutagenic as tested by Ames and mouse lymphoma assay.

Key words: bio-degradable PGA fiber material, Ames test, mouse lymphoma assay