临床应用的猪源性胶原蛋白片的生物相容性评价:体外细胞毒性、体内致敏和皮内反应性研究。

IF 5.2 3区 医学 Q1 ENGINEERING, BIOMEDICAL
Tae-Hoon Koo, Jason K Lee, Shawn P Grogan, Darryl D D'Lima
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引用次数: 0

摘要

医疗器械的生物相容性评价对于确保安全至关重要,ISO 10993系列是标准。然而,这些测试可能非常耗时且资源密集。本研究通过三种选择性ISO试验评估了猪真皮胶原基质的早期生物相容性:体外细胞毒性、体内致敏性和刺激性。从微型猪皮中水解纯化胶原蛋白,然后通过冻干加工成多孔薄片。提取液采用极性和非极性两种提取载体制备,用于生物检测。小鼠成纤维细胞的细胞毒性测试显示没有明显的细胞毒性作用,细胞形态和活力与对照组相当。豚鼠的致敏试验,包括皮内和局部暴露,没有发现过敏反应。在兔子身上的刺激试验没有显示出刺激的迹象。细胞毒性试验3天,致敏试验28天,刺激试验7天,均适合进行早期生物相容性筛选。这些结果证实胶原蛋白基质在一个月内无细胞毒性、无致敏性和无刺激性。在进行更复杂的ISO 10993研究之前,使用这三种测试可以早期识别不安全材料,减少时间、成本和动物使用。因此,它们对于医疗器械开发的早期可行性决策是适当和必要的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Biocompatibility Evaluation of Porcine-Derived Collagen Sheets for Clinical Applications: In Vitro Cytotoxicity, In Vivo Sensitization, and Intracutaneous Reactivity Studies.

Biocompatibility evaluation of medical devices is essential for ensuring safety, with ISO 10993 series being the standard. However, these tests can be time-consuming and resource-intensive. This study assessed the early-stage biocompatibility of a collagen matrix derived from porcine dermis using three selective ISO tests: in vitro cytotoxicity, in vivo sensitization, and irritation. Collagen was hydrolyzed, purified from miniature pig skin, and then processed into porous sheets via lyophilization. Extracts were prepared using both polar and non-polar extraction vehicles for biological testing. Cytotoxicity testing with mouse fibroblast cells showed no significant cytotoxic effects, with cell morphology and viability comparable to controls. Sensitization testing in guinea pigs, involving intradermal and topical exposure, revealed no allergic responses. Irritation testing in rabbits showed no signs of irritation. The cytotoxicity test took 3 days, the sensitization test 28 days, and the irritation test 7 days, all of which proved suitable for early biocompatibility screening. These results confirmed that the collagen matrix is non-cytotoxic, non-sensitizing, and non-irritant for a month. The use of these three tests enables early identification of unsafe materials, reducing time, cost, and animal use before advancing to more complex ISO 10993 studies. Therefore, they are appropriate and necessary for early feasibility decisions in medical device development.

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来源期刊
Journal of Functional Biomaterials
Journal of Functional Biomaterials Engineering-Biomedical Engineering
CiteScore
4.60
自引率
4.20%
发文量
226
审稿时长
11 weeks
期刊介绍: Journal of Functional Biomaterials (JFB, ISSN 2079-4983) is an international and interdisciplinary scientific journal that publishes regular research papers (articles), reviews and short communications about applications of materials for biomedical use. JFB covers subjects from chemistry, pharmacy, biology, physics over to engineering. The journal focuses on the preparation, performance and use of functional biomaterials in biomedical devices and their behaviour in physiological environments. Our aim is to encourage scientists to publish their results in as much detail as possible. Therefore, there is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced. Several topical special issues will be published. Scope: adhesion, adsorption, biocompatibility, biohybrid materials, bio-inert materials, biomaterials, biomedical devices, biomimetic materials, bone repair, cardiovascular devices, ceramics, composite materials, dental implants, dental materials, drug delivery systems, functional biopolymers, glasses, hyper branched polymers, molecularly imprinted polymers (MIPs), nanomedicine, nanoparticles, nanotechnology, natural materials, self-assembly smart materials, stimuli responsive materials, surface modification, tissue devices, tissue engineering, tissue-derived materials, urological devices.
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