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可降解聚乙醇酸纤维材料浸提液的遗传毒性研究
引用本文:韩倩倩,黄薇,宋谊萍,王召旭,李彦红,王春仁,黄清泉.可降解聚乙醇酸纤维材料浸提液的遗传毒性研究[J].癌变.畸变.突变,2012,24(5):359-361,364.
作者姓名:韩倩倩  黄薇  宋谊萍  王召旭  李彦红  王春仁  黄清泉
作者单位:1. 中国食品药品检定研究院医疗器械检定所生物材料与组织工程室,北京,100050
2. 首都医科大学附属北京口腔医院急诊科,北京,100050
基金项目:国家科技支撑计划项目(2012BAI22B01)
摘    要:目的:观察可降解聚乙醇酸(polyglycolic acid,PGA)生物支架材料是否具有引起基因突变的潜能。方法:采用Ames试验和小鼠淋巴瘤试验评价PGA浸提液的遗传毒性。结果:在Ames试验中,与阴性对照组比较,可降解PGA的浸提液均未引起4个试验菌株出现显著的回变菌落数改变(P0.5)。在小鼠淋巴瘤试验中,可降解PGA各个剂量浸提液组的克隆形成率较阴性对照组均无明显差异(P0.5),且显著小于阳性对照的克隆形成率(P0.5)。结论:可降解PGA纤维材料浸提液对于Ames试验菌株,小鼠淋巴瘤细胞无基因诱变性。

关 键 词:可降解PGA材料  Ames试验  小鼠淋巴瘤试验

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.Study of the genotoxicity of the bio-degradable polyglycolide fiber materials[J].Carcinogenesis,Teratogenesis and Mutagenesis,2012,24(5):359-361,364.
Authors:HAN Qian-qian  HUANG Wei  SONG Yi-ping  WANG Zhao-xu  LI Yan-hong  WANG Chun-ren  HUANG Qing-quan
Institution:1 (1.National Institute for Food and Drug Control,Center of Medical Devices,Beijing 100050;2.Beijing Stomatological Hospital, Emergency Department,Beijing 100050,China)
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.
Keywords:bio-degradable PGA fiber material  Ames test  mouse lymphoma assay
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