骨髓间充质干细胞-海螵蛸复合支架的热源试验评估  

Evaluation of Pyrogen Test for Bone Marrow MesenchymalStem Cell-Sea Cucumber Skeleton Composite Scaffold

作　　者：彭雅 覃裕 曹启辉 顾春松 吉杰 付英杰 欧凡 崔静 李丽莉 PENG Ya;QIN Yu;CAO Qi-hui;GU Chun-song;JI Jie;FU Ying-jie;OU Fan;CUI Jing;LI Li-li(Guizhou Orthopedic Hospital,Guiyang,550002,Guizhou;The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine,Guiyang,550002,Guizhou)

机构地区：[1]贵州省骨科医院,贵州贵阳550002 [2]贵州省中医药大学第二附属医院,贵州贵阳550002

出　　处：《黔南民族医专学报》2024年第3期253-255,共3页Journal of Qiannan Medical College for Nationalities

基　　金：贵阳市科技局2013社会发展与民生科技计划(2013103-40);贵州省教育厅自然科学研究项目[黔教育KY发(2012)040号]。

摘　　要：目的:对兔骨髓间充质干细胞复合海螵蛸生物支架进行热源试验检测,观察白兔的发热反应,通过对白兔体温温度变化的评估来判断复合支架植入生物体内的安全性。方法:本测试依据《医疗器械生物学评价标准》,选取3只健康成年新西兰白兔,从耳缘静脉缓慢将复合支架浸提液注入白兔体内,对比注射前后白兔体温变化。结果:每只新西兰大白兔的体温升高值均<0.6℃,三只白兔体温升高总值为1.2℃<1.4℃,符合热原试验检测要求。结论:骨髓间充质干细胞复合海螵蛸生物支架未含明显致热原物质,达到生物材料应用安全性标准。Objective:To conduct a pyrogen test on rabbit bone marrow mesenchymal stem cell(BMSC)composite sea cucumber skeleton bioscaffold and observe the febrile response in white rabbits,thereby assessing the safety of the composite scaffold implanted into living organisms based on changes in body temperature.Methods:Following the standards of"Biological Evaluation of Medical Devices,"this test involved selecting 3 healthy adult New Zealand white rabbits and slowly injecting the extract of the composite scaffold into the rabbits'ears via the marginal ear vein.The changes in body temperature before and after injection were compared.Results:The temperature increase in each New Zealand white rabbit was less than 0.6°C,and the total temperature increase in all three rabbits was 1.2°C,which is less than 1.4°C,meeting the requirements of the pyrogen test.Conclusion:The bone marrow mesenchymal stem cell composite sea cucumber skeleton bioscaffold does not contain significant pyrogenic substances and meets the safety standards for the application of biomaterials.

关 键 词：热源试验 生物复合支架 海螵蛸 骨髓间充质干细胞 

分 类 号：R318[医药卫生—生物医学工程]