中国组织工程研究2018，Vol.22Issue(10)：1534-1539,6.DOI:10.3969/j.issn.2095-4344.0712
组织诱导性材料生物安全性评价研究策略与实践
Biosafety evaluation strategy and practice of tissue induced biomaterials
摘要
Abstract
BACKGROUND: Due to the complexity of tissue induced biomaterials, the current biosafety evaluation standard is not available. For years, to choose an effective evaluation strategy and practice in tissue induced materials has been always a hot topic, but still with no conclusion. The existence of this problem results in numerous issues for manufactures when conducting the biosafety evaluation of tissue induced medical devices. OBJECTIVE: To formulate the biosafety evaluation strategy that should be followed by the material samples at the research and development stage and to provides some ideas and lessons for the selection of the product biology experimental items to be listed and registered. METHODS: In 2016, a statistical analysis was carried out for biological test items of tissue induced biomaterials. Cytotoxicity, irritation and sensitization tests were the most commonly used tests for biomaterials and medical devices. A biosafety evaluation only via the above three tests had been applied in 58 kinds of materials with 81 batches of samples. In this study, immune toxicity tests were performed in 17 kinds of materials and biodegradation tests were done in some samples. RESULTS AND CONCLUSION: It had been found that different test programs or evaluation strategies may be adopted in the product development or listing registration stage. At early stage of development, cytotoxicity, irritation and sensitization tests are suitable for sample screening. In the later stage of research and development, more in-depth tests, such as subchronic toxicity, degradation and immunity toxicity, should be employed to meet the safety evaluation requirements.关键词
组织诱导性生物材料/生物安全性评价/实验项目/筛选实验/免疫学实验/体外实验分类
医药卫生引用本文复制引用
邹文,袁暾,蔡永福,郑利萍,梁洁..组织诱导性材料生物安全性评价研究策略与实践[J].中国组织工程研究,2018,22(10):1534-1539,6.基金项目
国家重点研发计划(2016YFC1103202)资助 （2016YFC1103202）
2016年成都市第三批科技项目(2015-BZ00-00046-ZG)资助 the National Key Research and Development Program of China,No.2016YFC1103202 （2015-BZ00-00046-ZG）
the Third-Batch Scientific Research Program of Chengdu in 2016,No.2015-BZ00-00046-ZG （）
