CN107525916A - 模拟人牙本质的微孔屏障片 - Google Patents

模拟人牙本质的微孔屏障片 Download PDF

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CN107525916A
CN107525916A CN201710152616.4A CN201710152616A CN107525916A CN 107525916 A CN107525916 A CN 107525916A CN 201710152616 A CN201710152616 A CN 201710152616A CN 107525916 A CN107525916 A CN 107525916A
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dentine
people
microporous barrier
barrier piece
correlation
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林红
郑刚
王晨
黄麟
董利民
蒋若丹
胡孟龙
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Peking University School of Stomatology
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Peking University School of Stomatology
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
    • G01N33/5014—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics for testing toxicity
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility

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Abstract

本发明涉及一种模拟人牙本质构造的微孔材料屏障片。尤其适用于模拟人牙本质的通透性能，用于牙本质屏障细胞毒性试验等相关利用人牙本质开展各种医学研究及医疗器械性能评价的微孔屏障片。借助模拟人牙本质的微孔屏障片进行各种相关生物医学检验和实验，可以避免因采用人牙本质而存在的不同性别、不同年龄、不同体质、不同地区和人种的牙本质之间的差异，使相关的检验和实验结果更具可靠性和可比性，使相关的医学检验和实验标准化。模拟人牙本质微孔屏障片的最重要特点是使相关的生物医学检验和实验摆脱对人体组织的依赖。

Description

模拟人牙本质的微孔屏障片
技术领域：
本发明涉及一种模拟人牙本质构造的微孔材料屏障片。尤其适用于模拟人牙本质的通透性能，用于牙本质屏障细胞毒性试验等相关利用人牙本质开展各种医学研究及医疗器械性能评价的微孔屏障片。
背景技术：
人类的牙齿材质由牙釉质、牙本质和牙骨质构成。牙冠的最外层是约2至2.5mm厚的牙釉质。牙本质被牙釉质包裹，其内部存在的约3至5微米的牙本质小管与牙髓组织相通，承担牙体组织的新陈代谢作用。
当牙齿发生龋病时，需要采用人工材料对侵入牙本质的龋洞进行充填修补，由于牙本质小管与敏感的牙髓组织相通，作为三类医疗器械管理的牙科补牙材料的生物相容性是评价材料对人体安全性的重要指标。到目前为止，评价此类牙科补牙材料的方法是采用“人牙本质屏障法”，检测材料的细胞毒性。这种检测方法是在体外条件下，将一定厚度的人牙本质，放置在牙科补牙材料检品浸提液与细胞培育环境之间，模仿临床上材料的溶出物透过牙本质与牙髓细胞接触的实际情况，观察材料浸提液中的物质对细胞的影响。由于不同性别、不同年龄、不同地区和人种的牙本质之间存在差异，完全相同的离体健康人牙本质难以找寻，因此，这种直接采用人牙本质的细胞毒生物性能试验结果是存在不确定性的。模拟人牙本质材料正是为了解决上述问题及一切利用人牙本质进行的各种医学模拟试验而设计的。
发明内容：
模拟人牙本质的微孔屏障片采用羟基磷灰石或其他具有良好生物相容性的材料，制成直径6mm至15mm，厚0.5mm的圆片，并具有不低于人牙本质的硬度。圆片的表面和内部有连通的微孔分布，或者有沿圆片厚度方向，两面直接贯通的微孔分布。微孔直径小于10μm，孔距在5μm至20μm之间。材料对水的通透性能与人牙本质相近，并具有稳定、可控的通透率。
本发明的外形结构、外形尺寸、材质、孔的形状和数量、孔径的大小不受限制，根据实际需求可以设计成不同规格的微孔屏障片，这样的变换均包含在本发明的保护范围之内。
附图说明和具体实施方式：
下面结合附图和具体实施方式对本发明作进一步详细的说明。
附图1和图2是模拟牙本质微孔屏障片的结构示意图。
微孔屏障片为圆形薄片，是采用微孔材料加工而成的。微孔屏障片的上表面2与下表面3平行，表面的微孔1均匀分布。在微孔屏障片内部，微孔之间可以是连通的，也可以是上下两面贯通的，如图2微孔4所示。

Claims (5)

1.一种由微孔材料构成的圆片，圆片的上下两个圆形表面的微孔是贯通的。
2.根据权利要求1所述的圆片，其采用的材质具有良好的生物相容性。
3.根据权利要求1所述的圆片，其表面硬度不低于健康人牙本质。
4.根据权利要求1所述的圆片，其特征在于：上下表面贯通微孔的直径小于10μm，孔距在5μm至20μm之间。
5.根据权利要求1所述的圆片，其特征在于：圆片的上下表面之间具有液体通透性，其在特定的条件下，单位时间的透水量与健康人牙本质近似。
CN201710152616.4A 2017-03-15 2017-03-15 模拟人牙本质的微孔屏障片 Pending CN107525916A (zh)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101141987A (zh) * 2005-02-23 2008-03-12 Hi-Lex株式会社 医用材料、人工牙根及医疗材料的制造方法
CN102036694A (zh) * 2008-05-30 2011-04-27 华沙整形外科股份有限公司 生物陶瓷和生物聚合物复合材料
CN102387822A (zh) * 2009-04-03 2012-03-21 华沙整形外科股份有限公司 具有生物活性材料的医用植入体及其制造方法
CN202626190U (zh) * 2012-06-26 2012-12-26 中国人民解放军第四军医大学口腔医院 一种用于体外测定牙齿充填修复材料细胞毒性的装置

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101141987A (zh) * 2005-02-23 2008-03-12 Hi-Lex株式会社 医用材料、人工牙根及医疗材料的制造方法
CN102036694A (zh) * 2008-05-30 2011-04-27 华沙整形外科股份有限公司 生物陶瓷和生物聚合物复合材料
CN102387822A (zh) * 2009-04-03 2012-03-21 华沙整形外科股份有限公司 具有生物活性材料的医用植入体及其制造方法
CN202626190U (zh) * 2012-06-26 2012-12-26 中国人民解放军第四军医大学口腔医院 一种用于体外测定牙齿充填修复材料细胞毒性的装置

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