黔南民族医专学报2024,Vol.37Issue(3) :253-255.

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 Mesenchymal Stem Cell-Sea Cucumber Skeleton Composite Scaffold

彭雅 覃裕 曹启辉 顾春松 吉杰 付英杰 欧凡 崔静 李丽莉
黔南民族医专学报2024,Vol.37Issue(3) :253-255.

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 Mesenchymal Stem Cell-Sea Cucumber Skeleton Composite Scaffold

彭雅 1覃裕 1曹启辉 1顾春松 2吉杰 1付英杰 1欧凡 1崔静 1李丽莉1
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作者信息

  • 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
  • 折叠

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.

Abstract

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 in-volved selecting 3 healthy adult New Zealand white rabbits and slowly injecting the extract of the composite scaf-fold 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℃,and the total temperature increase in all three rabbits was 1.2℃,which is less than 1.4℃,meeting the require-ments of the pyrogen test.Conclusion:The bone marrow mesenchymal stem cell composite sea cucumber skele-ton bioscaffold does not contain significant pyrogenic substances and meets the safety standards for the applica-tion 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

Key words

pyrogen test/biological composite scaffold/sea cucumber skeleton/bone marrow mesenchy-mal stem cells

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基金项目

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2012040号)

出版年

2024
黔南民族医专学报
黔南民族医学高等专科学校

黔南民族医专学报

影响因子:0.235
ISSN:1008-4983
参考文献量14
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