發(fā)布時間：2018-07-02 22:01

  本文選題：自組裝肽 + 右旋氨基酸　； 參考：《中國現(xiàn)代醫(yī)學雜志》2017年01期

【摘要】：目的評價新型自組裝肽納米纖維水凝膠支架材料D-RADA16的生物相容性及安全性,為該材料的臨床推廣應用提供試驗依據(jù)。方法根據(jù)GB/T 16886.1-2011/ISO 10993-1∶2009《醫(yī)療器械生物學評價標準》,選取體外細胞毒性試驗、全身急性毒性試驗、皮內刺激試驗、溶血試驗、熱源試驗、微核試驗評價D-RADA16的生物相容性。結果細胞毒性試驗中,材料共培養(yǎng)組相對增殖率均90%,細胞毒性為1級,材料無細胞毒性。溶血試驗結果顯示,生物材料D-RADA16的溶血率為0.96%,符合5%的國家標準。各組小鼠活動正常,7 d內無小鼠死亡,各組動物未見中毒癥狀或不良反應,7 d后各組小鼠體質量比較,差異無統(tǒng)計學意義(P0.05)。7 d后處死動物,肝、脾、腎大體觀察和蘇木精-伊紅染色法染色未見異常。熱原試驗顯示,3只動物體溫升高,最高0.5℃,升高總數(shù)為1.2℃,符合1.4℃的國家標準。皮內刺激試驗顯示,兔各時間點注射肽溶液后原發(fā)性刺激指數(shù)均為0分。遺傳毒性試驗顯示,各實驗組與陰性對照組微核數(shù)比較,差異無統(tǒng)計學意義(P0.05),各實驗組與陽性對照組微核數(shù)比較,差異有統(tǒng)計學意義(P0.05),材料未見明顯致突變性。結論新型納米生物支架材料D-RADA16無細胞毒性、溶血作用、急性毒性、致熱原性、皮膚刺激性、遺傳毒性,具有良好的生物安全性和生物相容性,為材料進一步的細胞生物學研究及臨床應用提供理論依據(jù)。
[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，

本文編號：2091055