中文摘要：

目的：通过动物实验评价蚕丝-PLGA细丝混合编织支架材料的生物安全性，为该材料临床应用提供理论依据。方法：通过捻拧编织蚕丝纤维-PLGA细丝混合支架，蚕丝：PLGA的质量比为2：3。并制备该支架材料的浸提液。采用蚕丝纤维-PLGA细丝混合编织支架浸提液进行如下生物安全性的动物实验研究：急性全身毒性试验、皮内刺激试验、溶血试验、热原试验，并根据实验数据进行分析、评价。结果：蚕丝-PLGA混合编织支架材料为螺旋上升的绳索状，直径3．2mm。支架材料无急性全身毒性作用，无皮内刺激反应。支架材料溶血率为1．17％，小于5％，不具溶血作用，符合生物材料溶血试验的要求。热原试验表明，3只实验兔体温升高数分别为0．4℃、0．2℃、0．3℃，均低于0．6℃，总值小于1．4℃，不具热原反应。结论：蚕丝-PLGA混合编织支架材料具有良好的生物相容性。符合相关生物安全性的评价标准。

英文摘要：

Objective：To evaluate the biological safety of Silk - PLGA braided scaffold materials for providing the scientific and experimental basis for clinical application. Methods： Silk fibroin fiber was mixed with PLGA filament at ratio of 2： 3, then silk - PLGA scaffold was prepared by braiding them. Then the bio - safety of the silk - PLGA braided scaffold materials were as- sessed according to the relevant standards by acute systematic toxicity test, intracutaneous irritation test, hemolysis test and pyro- gen test. The experimental results were analyzed and assessed by criterion. Results： Silk -PLGA braided scaffold showed spiral rope shape and its diameter was 3.2 mm. In acute systematic toxicity test of the silk - PLGA scaffold materials, no obvious toxic reaction was observed. In intracutaneous irritation test, no intraeutaneous irritation reaction was found. In hemolysis test, the he- molysis rate of the silk - PLGA scaffold materials was 1.17%, less than 5%. It showed that the scaffold materials was no hemoly- sis. In pyrogen test, the highest temperature increment of experimental rabbit were 0.4℃, 0.2℃, 0.3℃ respectively, so there was no pyrogen reaction. Conclusion： Silk - PLGA mixed scaffold materials have good biological safety. It is a potential scaffold material for tissue engineered ligament or tendon.