中国组织工程研究 ›› 2025, Vol. 29 ›› Issue (28): 6046-6051.doi: 10.12307/2025.487

• 材料力学及表面改性 material mechanics and surface modification • 上一篇    下一篇

多次冻融循环后成品异体肌腱性能的变化

胡  凯1,郭永琴1,邵怡然1,汪晶晶2   

  1. 1上海亘从生物医用材料研究中心,上海市   201201;2上海亚朋生物技术有限公司,上海市   201201
  • 收稿日期:2024-05-21 接受日期:2024-07-27 出版日期:2025-10-08 发布日期:2024-12-07
  • 通讯作者: 胡凯,硕士,上海亘从生物医用材料研究中心,上海市 201201
  • 作者简介:胡凯,男,1993年生,安徽省安庆市人,汉族,2019年上海师范大学毕业,硕士,主要从事生物医用材料的研究与转化研究。
  • 基金资助:
    浦东新区科技发展基金产学研专项(生物医药)项目(PKX2023-S15),项目名称:同种异体肌腱临床试验研究,项目负责人:汪晶晶

Changes in properties of treated allogeneic tendons after multiple freeze-thaw cycles

Hu Kai1, Guo Yongqin1, Shao Yiran1, Wang Jingjing2   

  1. 1Shanghai Gencong Biomedical Materials Research Center, Shanghai 201201, China; 2Shanghai Yapeng Biotechnology Co., Ltd., Shanghai 201201, China
  • Received:2024-05-21 Accepted:2024-07-27 Online:2025-10-08 Published:2024-12-07
  • Contact: Hu Kai, MS, Shanghai Gencong Biomedical Materials Research Center, Shanghai 201201, China
  • About author:Hu Kai, MS, Shanghai Gencong Biomedical Materials Research Center, Shanghai 201201, China
  • Supported by:
    Pudong New Area Science and Technology Development Fund Industry-University-Research Special Project (Biomedicine), No. PKX2023-S15 (to WJJ)

摘要:


文题释义:

冻融循环:是指材料在零度以下环境中冷冻处理,之后又在零度以上环境中解冻处理,反复多次的一个过程,这一过程中材料内的水处于结冰、融化循环转变状态。
同种异体肌腱:从人类不同个体内获取与制备用于移植的肌腱组织,一般经过深低温冷冻、化学处理等工艺处理,在包装后经由辐射灭菌得到成品。


背景:用于临床移植的异体肌腱在应用前需进行相应处理,在处理成品至正式使用期间一般会面临多周期冻融循环的情况,目前针对成品异体肌腱经历多周期冻融循环后的性能变化还未见相关报道。

目的:探究异体肌腱在经历多周期冻融循环后的力学性能及成分变化。
方法:取经法规规定工艺处理后的成品异体肌腱,在-40 ℃(或-80 ℃)条件下分别冻融循环3,6,10次,对相应条件冻融后的异体肌腱进行力学实验及DNA、硫酸糖胺聚糖、羟脯氨酸含量和总蛋白含量检测。

结果与结论:①在-40 ℃条件下冷冻保存,冻融循环3,6,10次组之间的最大载荷、最大载荷伸长率、抗拉强度和弹性模量比较差异均无显著性意义(P > 0.05);在-80 ℃条件下冷冻储存,冻融循环3,6,10次组之间的最大载荷、最大载荷伸长率比较差异无显著性意义(P > 0.05),冻融循环3次组抗拉强度高于冻融循环6,10次组(P < 0.05),冻融循环3次组弹性模量高于冻融循环10次组(P < 0.05);②在-40 ℃(或-80 ℃)条件下冷冻保存,冻融次数不影响异体肌腱中DNA、羟脯氨酸、总蛋白和硫酸糖胺聚糖含量;③结果表明,在-40 ℃储存时,10次以内冻融循环不影响异体肌腱的性能;而在-80 ℃储存时,异体肌腱冻融循环次数应控制在6次以内。

https://orcid.org/0000-0003-1694-7779 (胡凯) 

中国组织工程研究杂志出版内容重点:生物材料;骨生物材料;口腔生物材料;纳米材料;缓释材料;材料相容性;组织工程

关键词: 同种异体肌腱, 冻融循环, 力学性能, 成分检测, 工艺处理, 工程化肌腱

Abstract: BACKGROUND: Allogeneic tendons are often used in clinical treatment of tendon and ligament injuries, which need to be treated before clinical application. At present, allogeneic tendons will face multiple freeze-thaw cycles after cryopreservation, but there is no relevant research on the changes in the properties of the treated allogeneic tendon after several freeze-thaw cycles.
OBJECTIVE: To explore the changes in mechanical properties and composition of allogeneic tendon after multiple freeze-thaw cycles.
METHODS: The treated allogeneic tendon was frozen and thawed 3, 6, and 10 times at -40 ℃ (or -80 ℃), respectively. The mechanical test, DNA content, glycosaminoglycan sulfate, hydroxyproline content and total protein content of the allogeneic tendon after freezing and thawing were detected. 
RESULTS AND CONCLUSION: (1) There was no significant difference in the maximum load, maximum load elongation, tensile strength and elastic modulus between groups after freezing-thawing cycles for 3, 6, and 10 times at -40 ℃ (P > 0.05). There was no significant difference in the maximum load and maximum load elongation between the groups after freezing-thawing cycles for 3, 6, and 10 times at -80 ℃ (P > 0.05). The tensile strength of the group with 3 cycles of freezing and thawing was higher than that of the groups with 6 and 10 cycles of freezing and thawing (P < 0.05). The elastic modulus of the group with 3 cycles of freezing and thawing was higher than that of the group with 10 cycles of freezing and thawing (P < 0.05). (2) The freezing and thawing times did not affect the contents of DNA, hydroxyproline, total protein, and sulfated glycosaminoglycan in allogeneic tendon when stored at -40 ℃ (or -80 ℃). (3) These findings suggest that in -40℃ storage, the performance of the allogeneic tendon should not be affected by taking out and putting back the tendon less than 10 times, while in -80 ℃ storage, the allogeneic tendon should be taken out and put back less than 6 times.

Key words: allogeneic tendon, freeze-thaw cycle, mechanical property, component detection, process treatment, engineered tendon

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