经戊二醛固定的牛心包生物瓣膜材料的生物安全性评价  

The Biosafety Evaluation of Glutaraldehyde-fixed Bovine Pericardium Biovalve Materials

作　　者：黄虹蓉 林钟石 臧德跃 袁丽欣 钟文雨 林柏佑 刘尧 HUANG Hong-rong;LIN Zhong-shi;ZANG De-yue;YUAN Li-xin;ZHONG Wen-yu;LIN Bai-you;LIU Yao(Department of In-vitro Diagnostic Reagent Testing,Shenzhen Testing Center of Medical Divices,Shenzhen 518000,Guangdong,China;Department of Passive Medical Device Testing,Shenzhen Testing Center of Medical Divices,Shenzhen 518000,Guangdong,China)

机构地区：[1]深圳市医疗器械检测中心体外诊断试剂检测部,广东深圳518000 [2]深圳市医疗器械检测中心无源医疗器械检测部,广东深圳518000

出　　处：《医学信息》2022年第24期95-101,共7页Journal of Medical Information

摘　　要：目的对经戊二醛固定的牛心包瓣膜材料进行生物安全性评价,为其在未来的临床使用中提供安全有效的依据。方法依据GB/T 16886/ISO 10993系列标准要求,选择体外细胞毒性试验噻唑盐比色法(MTT)、皮肤致敏试验、皮内反应试验、热原试验、急性全身毒性试验、遗传毒性组合试验(Ames试验、体外小鼠淋巴瘤tk试验和体外哺乳动物染色体损伤的细胞遗传毒评估试验)和溶血试验等对经戊二醛固定的牛心包瓣膜材料进行生物安全性评价,通过细胞存活率、溶血率的计算结果及对动物皮肤红斑和水肿反应、刺激反应、毒性反应的观察以及对潜在的致突变性和致癌性的评估,判断牛心包瓣膜材料的生物安全性。结果牛心包瓣膜材料的细胞存活率为73.60%;皮肤致敏反应等级为0级;皮内反应总平均记分为0;急性全身毒性试验浸提液组与对照组小鼠体重无显著性差异;热原试验家兔的体温升高均低于0.6℃;溶血率为1.26%;Ames试验浸提液组回变菌落数均未比阴性组回变菌落数增加1倍或者1倍以上;MLA试验浸提液组MF值与阴性对照相比无超过126×10^(-6)的增长;体外哺乳动物染色体损伤的细胞遗传毒评估试验浸提液组染色体结构畸变率与阴性对照无显著性差异。结论经戊二醛固定的牛心包瓣膜材料符合国家医疗器械标准的要求,表现出良好的生物安全性。Objective To evaluate the biosafety of glutaraldehyde-fixed bovine pericardial valve materials and provide a safe and effective basis for their future clinical use.Methods According to the requirements of GB/T 16886/ISO 10993 series standards,the biological safety of glutaraldehydefixed bovine pericardial valve materials was evaluated by MTT assay,skin sensitization test,intradermal reaction test,pyrogen test,acute systemic toxicity test,genetic toxicity combination test(Ames test,in vitro mouse lymphoma tk test and in vitro mammalian chromosome damage cell genetic toxicity assessment test)and hemolysis test.Through the calculation results of cell survival rate and hemolysis rate,the observation of animal skin erythema and edema reaction,stimulation reaction,toxicity reaction and the evaluation of potential mutagenicity and carcinogenicity,the biosafety of bovine pericardial valve material was judged.Results The cell survival rate of bovine pericardial valve material was 73.60%.The skin sensitization reaction grade was 0;the total average score of intradermal reaction was 0;there was no significant difference in body weight between the extract group and the control group in acute systemic toxicity test.The temperature rise of rabbits in pyrogen test was lower than 0.6℃.Hemolysis rate was1.26%.The number of revertant colonies in the Ames test extract group did not increase by one time or more than one time compared with the negative group.The MF value of the MLA test extract group did not increase by more than 126×10^(-6)compared with the negative control;cytogenetic toxicity assessment of mammalian chromosome damage in vitroThere was no significant difference in chromosome structural aberration rate between the extract group and the negative control.Conclusion The glutaraldehyde-fixed bovine pericardial valve materials meets the requirements of national medical device standards and shows good biosafety.

关 键 词：生物安全性 戊二醛 牛心包 生物瓣膜 

分 类 号：R318[医药卫生—生物医学工程]