眼巩膜生物补片的亚慢性全身毒性试验研究  

Experimental Study on Subchronic Systemic Toxicity of Ocular Sclera Biologic Patch

作　　者：周小婷 周静 周岩 陈国铭 柳小军 刘康博 张丹丹 ZHOU Xiaoting;ZHOU Jing;ZHOU Yan;CHEN Guoming;LIU Xiaojun;LIU Kangbo;ZHANG Danan(Henan Medical Equipment Inspection Institute,Zhengzhou 450000,China)

机构地区：[1]河南省医疗器械检验所,河南省郑州市450000

出　　处：《组织工程与重建外科杂志》2020年第6期462-466,共5页Journal of Tissue Engineering and Reconstructive Surgery

基　　金：河南省重点科技攻关项目(202102310467)。

摘　　要：目的评价眼巩膜生物补片的亚慢性全身毒性。方法参考GB/T 16886.11-2011/ISO10993.11∶2006的试验方法,将40只SD大鼠随机分成2组,以植入的途径进行亚慢性全身毒性试验。通过对大鼠体质量、血液学、临床生化、脏器重量、组织病理学等检测指标,综合分析眼巩膜生物补片的亚慢性全身毒性。结果两组大鼠均未观察到有生物学意义的异常指标。结论本研究评价的眼巩膜生物补片未观察到亚慢性全身毒性。Objective To evaluate the subchronic systemic toxicity of ocular sclera biologic patch.Methods According to the test method of 16886.11-2011/ISO10993.11:2006,forty SD rats were randomly divided into two groups and the sample was administrated by implantation.After implantation,the results of body weight,hematology,clinical chemistry,organ weight and histopathology were collected and analyzed to determine the subchronic toxicity of the ocular sclera biologic patch.Results No biological adverse indicators were observed in the two groups.Conclusion The ocular sclera biologic patch has no subchronic systemic toxicity.

关 键 词：眼巩膜 生物补片 亚慢性全身毒性 牛心包 

分 类 号：R318.08[医药卫生—生物医学工程]