富血小板—白细胞凝胶/牡蛎复合型人工骨替代物的生物安全性初步评估  

Preliminary Evaluation of Bio-safety of Artificial Bone Substitute Combination Rich Platelet-Leukocyte Gel and Oyster

作　　者：杨伟瑞 唐良华[2] YNNG Weirui;TANG Lianghua(Guiyang University of Chinese Medicine,Guiyang 550002,China;The Second Affiliated Hospital of Guiyang University of Chinese Medicine,Guiyang 550003,Guizhou,China)

机构地区：[1]贵阳中医学院,贵州贵阳550002 [2]贵阳中医学院第二附属医院骨二科,贵州贵阳550003

出　　处：《贵阳中医学院学报》2019年第1期21-25,共5页Journal of Guiyang University of Chinese Medicine

摘　　要：目的:将牡蛎与富血小板—白细胞凝胶进行结合,并对该材料的生物安全性进行初步评估;方法:将牡蛎的形状进行重塑并使用相应的化学试剂进行脱脂脱蛋白处理,使用时采取进一步的灭菌处理。选取成年的新西兰大耳兔5只,采用抗凝血管抽取血液约3 m L,使用3200r/min转速离心处理15min,取上清液约1 m L与含10%氯化钙的凝血酶溶液约0. 2 m L同时注入牡蛎小孔处,完成富血小板—白细胞凝胶/牡蛎复合型人工骨替代物的制作。按照国家医疗器械与有机材料的生物安全性评估方法制成该材料的浸提液。使用浸提液通过热原实验、溶血实验对富血小板—白细胞凝胶/牡蛎复合型人工骨替代物的生物安全性进行初步评估。结果:热原实验中实验兔的温度升高值分别为0.3℃、0.4℃、0.7℃、0.2℃、0.2℃;溶血实验中该材料的溶血率约为1%。结论:富血小板—白细胞凝胶/牡蛎复合型人工骨替代物无溶血作用及无致热源的存在,说明具有较为良好的生物安全性。Objective: Preliminary evaluation of biosafety of artificial bone composite which combined with platelet-leukocyte gel and oyster. Methods: oysters shell were selected and shaped into bars,then degreasing and deproteinization by using corresponding chemical reagents,further sterilization before using. Five adult New Zealand rabbits were selected and their blood was extracted about 3mL by using anticoagulant blood vessels. After centrifugation for 15 min at a speed of 3200r/min,nearly 1 m L supernate and 0.2 m L thrombin solution containing 10% calcium chloride were injected into oyster pores to produce the artificial bone substitute combination rich platelet-leukocyte gel and oyster. According to the biosafety assessment method of national medical devices and organic materials,the extraction liquid of the material was prepared. The biosafety of this artificial bone substitute was preliminarily evaluated by pyrogen assay and hemolysis assay. Results: The elevated temperature of experimental rabbits were 0.3 ℃,0.4 ℃ and 0.7 ℃,0.2 ℃ and 0.2 ℃ in pyrogen experiment and the hemolytic rate of experimental rabbits was about 1% in hemolytic test. Conclusions: the artificial bone substitute combination rich platelet-leukocyte gel and oyster has good biological safety without hemolysis and pyrogen.

关 键 词：富血小板—白细胞凝胶/牡蛎复合型人工骨替代物 生物安全性 热原实验 溶血实验 

分 类 号：R68[医药卫生—骨科学] R318.17[医药卫生—外科学]