用微核试验评价生物羊膜遗传毒性的研究

Study on the Genotoxicity of the Biological Amnion Evaluated by Mouse Bone Marrow Micronucleus Study

目的:用微核试验评价生物羊膜引起遗传毒性的可能性。方法参照《GB/T16886.3-1997/ISO10993-3:1992》的方法及指导原则进行试验。结果:在研究过程中所有动物临床表现和体重变化都是正常的,生物羊膜浸提液与阴性对照嗜多染红细胞(PCEs)/红细胞(RBC)总数无显著性差异(P>0.05),没有出现遗传毒性的迹象。结论:生物羊膜用微核试验评价不会引起遗传毒性。

Objective： Use mouse bone marrow micronucleus study to evaluate the possibility of genotoxicity of the biological amnion . Methods： The study was based on the requirements of the GB/T16886.3-1997/ISO10993-3：1992 Results： All animals appeared clinically normal throughout the study. Weight changes over the course of the study were normal. There are no notable differences between the extract of the biological amnion and the negative control of the Percent PCE （P〉0.05）.There was no evidence of genotoxicity. Conclusion： Under the condition of this study, the test article can not induce genotoxicity.