新型自组装肽纳米纤维支架材料的生物安全性评价

发布时间：2018-07-02 22:01

  本文选题：自组装肽 + 右旋氨基酸　； 参考：《中国现代医学杂志》2017年01期

【摘要】：目的评价新型自组装肽纳米纤维水凝胶支架材料D-RADA16的生物相容性及安全性,为该材料的临床推广应用提供试验依据。方法根据GB/T 16886.1-2011/ISO 10993-1∶2009《医疗器械生物学评价标准》,选取体外细胞毒性试验、全身急性毒性试验、皮内刺激试验、溶血试验、热源试验、微核试验评价D-RADA16的生物相容性。结果细胞毒性试验中,材料共培养组相对增殖率均90%,细胞毒性为1级,材料无细胞毒性。溶血试验结果显示,生物材料D-RADA16的溶血率为0.96%,符合5%的国家标准。各组小鼠活动正常,7 d内无小鼠死亡,各组动物未见中毒症状或不良反应,7 d后各组小鼠体质量比较,差异无统计学意义(P0.05)。7 d后处死动物,肝、脾、肾大体观察和苏木精-伊红染色法染色未见异常。热原试验显示,3只动物体温升高,最高0.5℃,升高总数为1.2℃,符合1.4℃的国家标准。皮内刺激试验显示,兔各时间点注射肽溶液后原发性刺激指数均为0分。遗传毒性试验显示,各实验组与阴性对照组微核数比较,差异无统计学意义(P0.05),各实验组与阳性对照组微核数比较,差异有统计学意义(P0.05),材料未见明显致突变性。结论新型纳米生物支架材料D-RADA16无细胞毒性、溶血作用、急性毒性、致热原性、皮肤刺激性、遗传毒性,具有良好的生物安全性和生物相容性,为材料进一步的细胞生物学研究及临床应用提供理论依据。
[Abstract]:Objective to evaluate the biocompatibility and safety of a new self-assembled peptide nanofiber hydrogel scaffold D-RADA16 and to provide experimental evidence for its clinical application. Methods according to GB / T 16886.1-2011 / ISO 10993-1: 2009, the biocompatibility of D-RADA16 was evaluated by in vitro cytotoxicity test, systemic acute toxicity test, intradermal stimulation test, hemolysis test, heat source test and micronucleus test. Results in the cytotoxicity test, the relative proliferation rate of the co-culture group was 90%, the cytotoxicity was grade 1, and the material had no cytotoxicity. The results of hemolysis test showed that the hemolysis rate of D-RADA16 was 0.96, which met the national standard of 5%. No mice died within 7 days after normal activity in each group. The body mass of each group was compared after 7 days without toxic symptoms or adverse reactions. The difference was not statistically significant (P0.05) after 7 days, the animals were killed, liver and spleen were killed. There was no abnormality in renal gross observation and hematoxylin-eosin staining. The pyrogen test showed that the body temperature of the three animals increased, the highest was 0.5 鈩，

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