生物羊膜亚慢性毒性研究  

The Subchronic Toxicity Study on the Biological Amnion

作　　者：孙立魁[1] 辛仁东[1] 朱雪涛[1] 谢克勤[2] 

机构地区：[1]国家食品药品监督管理局济南医疗器械质量监督检验中心,山东济南250101 [2]山东大学公共卫生学院毒理学研究所,山东济南1250012

出　　处：《中国医疗器械杂志》2007年第1期48-51,共4页Chinese Journal of Medical Instrumentation

摘　　要：根据国家标准GB/T16886．11:全身毒性试验及GB／T16886．6植入后局部反应试验的方法及指导原则,对生物羊膜进行亚慢性毒性试验,为期92天。对所有动物每天进行观察,在试验期结束时进行血液、生化和组织病理学检查,将试验组和对照组进行对比,评价引发全身毒性的可能性。试验组和对照组进行对比,大鼠的一般行为、体重增长、进食、尿常规、血液学、血生化、脏器重量及病理学检查均未见显著性差异。生物羊膜植入皮下组织92天后,没有导致毒性效应的特异性变化,不会引起慢性毒性。在严格控制质量的前提下可形成规模生产,其开发前景可观。As the new type comea ulcer renovation material, the biological amnion is to be implanted into the human body for a long time, a subchronic toxicity study in rats is made to evaluate its possibility of subchronic toxicity .The study is based on the requirements of ＂Biological Evaluation of Medical Devices, Part 11： Tests for systemic toxicity and Part 6： Tests for local effects after implantation＂. After the implantation of examples to be tested,animals were observed daily for mortality and 92 days later the possible subchronic toxicity was evaluated .And a necropsy was conducted and the selected organs were excised ,weighed, and processed histologically. Body weights, organ weights, organ/body weight ratios ,hematology values and clinical chemistry values were analyzed statistically. Results show that daily clinical observation, body weights, necropsy findings, organ weights and organ/bedy weight ratios were within acceptable limits in test and control treatment groups. There were no obvious changes in histopathology, hematology values or clinical chemistry values in either male or female rats and no notable differences between the biological amnion and the control amnion. This study proves that, the cornea ulcer renovation material,the biological amnion does not induce subchronic toxicity.

关 键 词：亚慢性毒性 生物羊膜 角膜溃疡修复 

分 类 号：R318.08[医药卫生—生物医学工程]