中国现代医学杂志2017，Vol.27Issue(1)：16-23,8.DOI:10.3969/j.issn.1005-8982.2017.01.004
新型自组装肽纳米纤维支架材料的生物安全性评价
Biological safety of designer self-assembling peptide nanofiber hydrogel scaffolds
摘要
Abstract
Objective To evaluate the biological safety of designer self-assembling peptide (SAP) nanofiber hydrogel scaffolds D-RADA16, so as to provide experimental evidence for the clinical application of the ma-terial. Methods According to Biological Evaluation of Medical Devices (GB/T 16886.1-2011/ISO 10993-1:2009), physiological saline lixivium of the biomaterial or the hydrogel biomaterial was used for cyto-toxicity test, hemolysis test, acute toxicity test, pyrogen test, intradermal irritation test, and micronucleus test to evaluate the biocompatibility of the material. Results In the cytotoxicity test, the relative growth rate of the experimental group was above 90%, and the toxicity of D-RADA16 was graded 1, indicating no cytotoxicity. The hemolysis rate of the lixivium was 0.96%, which was lower than the national standard (< 5%). The activity of mice was normal in the acute toxicity test. No animal died and no toxicity symptom or adverse effect was shown within 7 d. The increase of average daily weight showed no statistically significant difference between the experimental group and the control group after 7 d ( >0.05). The mice were sacrificed after 7 d, and no abnormal changes were observed in general observation and HE staining of the liver, spleen or kidneys. The maximum increase of the body temperature in the experimental group was 0.5℃, and the total increase of body temperature of the three experimental animals was 1.2℃, which met the national standard in the pyrogen test (<1.4℃). Intradermal irritation test showed that the primary irritation index was 0 at every defined time point. In the micronucleus test, the results showed that there was no statistically significant difference at mi-cronucleus number between the experimental groups and the negative control group ( >0.05), and there were statistically significant differences between the experimental groups and the positive control group ( <0.01). Therefore, potential mutagenicity was not observed in the micronucleus test. Conclusions Designer SAP hydro-gel scaffolds D-RADA16 does not have cytotoxicity, hemolytic effect, acute toxicity, pyrogenicity, skin irritation or genetic toxicity. It has good biological safety and biocompatibility, therefore exhibits a promising clinical application prospect and provides theoretical basis for further research of cell biology study and clinical appli-cation.关键词
自组装肽/右旋氨基酸/细胞毒性/生物安全性Key words
self-assembling peptide/D-amino acid/cytotoxicity/biological safety分类
医药卫生引用本文复制引用
陈硕,蒋电明,何彬,周敖..新型自组装肽纳米纤维支架材料的生物安全性评价[J].中国现代医学杂志,2017,27(1):16-23,8.基金项目
国家自然科学基金 （）
