CN101693966A - 齿科用支架钢合金材料 - Google Patents

齿科用支架钢合金材料 Download PDF

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CN101693966A
CN101693966A CN200910234130A CN200910234130A CN101693966A CN 101693966 A CN101693966 A CN 101693966A CN 200910234130 A CN200910234130 A CN 200910234130A CN 200910234130 A CN200910234130 A CN 200910234130A CN 101693966 A CN101693966 A CN 101693966A
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CN101693966B (zh
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姚向东
张杏耀
姚超
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Nantong Jinri High-tech. Materials Co., Ltd.
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Abstract

一种齿科用支架钢合金材料，属于齿科材料技术领域。其化学元素及重量百分比为：钴62％-64％、铬28％-30％、钼4％-5％、钛0.3％-1.2％、硅0.2％-1.3％、铁0.2％-1.0％、锰0.2％-1.3％和碳0.1％-1.2％。本发明技术方案提供的齿科用支架钢合金材料由于具有与人体的生物相容性好、具有良好的耐腐蚀性能、溶血率＜5％、无急性全身毒性、细胞毒性不大于I级、无口腔粘膜刺激和无迟发性接触性致敏反应，因而具有理想的安全性；由于抗拉强度σb(MPa)可达767.1-789、延伸率(％)可达5.36-5.44和维氏硬度(HV)392.8-411，因而具有合适的强度、硬度、耐磨性和良好的可加工性能，能适应口腔内的软硬组织。

Description

齿科用支架钢合金材料
技术领域
本发明属于齿科材料技术领域，具体涉及一种齿科用支架钢合金材料。
背景技术
齿科用支架钢合金材料主要用于补修牙齿的卡环和基托，是生物金属材料中的一种。卡环和基托在牙科修复治疗中被广泛应用。如业界所知之理，齿科材料的安全性要求极为严苛，因为齿科材料制品长期置于口腔中，与人体组织直接接触，所以除了要求与人体组织有良好的亲和性外，其对于人体的溶血率、急性全身毒性、细胞毒性、口腔粘膜刺激、皮肤和粘膜的致敏均必须符合人体要求。同时对齿科材料的有效性要求同样极为严苛，因为在人们进食时，牙齿除咀嚼食物，经常接触各种酸性和碱性物质外，还长期处于口腔液体的环境中，因此齿科材料不仅必须对人体无毒无害，还必须具有高耐腐蚀性、合适的强度、硬度和耐磨性，能适应口腔内的软硬组织以及良好的可加工性。
正是由于包括齿科用支架钢合金材料在内的齿科用金属材料对安全性(生物相容性)和有效性(合金的物理性能)有着超乎寻常的技术要求，因此迄今为止我国除了上海齿科材料厂生产有齿科用镍-铬-铁锤造合金外，别无厂商涉足此领域，国际上也仅有美国、德国、日本和瑞士四国制造，并且日本在中国哈尔滨以独资方式建有哈尔滨千禄达医疗器械有限公司，生产前述的齿科用支架钢合金材料<企业生产许可证号：黑食药监械生产许20080135号，产品注册证号：黑食药监械(准)字2008第2630019号>。具有国际品牌的齿科用支架钢合金材料有美国的Vitallium，德国的Bayer、BEGO，其中德国BEGO品牌中的Wironit齿科用支架钢合金材料是国际公认的著名品牌。但是，或许出于对技术上的保密性和市场的占有性(垄断性)考虑，在已有的国内外文献中，均未见诸有关齿科用支架钢合金材料的报道，因此目前的现状：在我国市场所见诸的更具体地讲我国成千上万家义齿制作公司制造齿科用的卡环、基托所用的支架钢均由德国、日本、美国和瑞士占据绝对的统治地位，中国上海齿科材料厂生产的齿科用支架钢虽然可以讲也是十分优秀的，但不足以与前述国家所生产的齿科用支架钢合金材料在市场上竞争。前述国家所生产的齿科用支架钢合金产品虽价格昂贵，但因其性能优良、外形美观，故受到医院、义齿制作公司和患者的欢迎，市场的份额逐年上升，像北京、上海等发达城市，已大多选用国外产品完全取代国产品牌。鉴此，从产业自主的角度出发，必须开发具有符合人体安全性、使用性能优良和易于加工、外形美观的国产齿科用支架钢合金材料，同时摆脱齿科用支架钢合金材料对进口的绝对依赖和满足牙病患者享受牙病治疗的廉价性，下面将要介绍的技术方案便是在这种背景下产生的。
发明内容
本发明的任务在于提供一种对于人体既具有理想的安全性又具有优异的物理性能的齿科用支架钢合金材料。
本发明的任务是这样来完成的，一种齿科用支架钢合金材料，其化学元素及重量百分比为：钴62％-64％、铬28％-30％、钼4％-5％、钛0.3％-1.2％、硅0.2％-1.3％、铁0.2％-1.0％、锰0.2％-1.3％和碳0.1％-1.2％。
本发明技术方案提供的齿科用支架钢合金材料由于具有与人体的生物相容性好、具有良好的耐腐蚀性能、溶血率＜5％、无急性全身毒性、细胞毒性不大于I级、无口腔粘膜刺激和无迟发性接触性致敏反应，因而具有理想的安全性；由于抗拉强度σb(MPa)可达767.1-789、延伸率(％)可达5.36-5.44和维氏硬度(HV)392.8-411，因而具有合适的强度、硬度、耐磨性和良好的可加工性能，能适应口腔内的软硬组织。
具体实施方式
下面的实施例配方经真空熔炼及真空浇铸后得到用于加工牙齿修补时使用的卡环和基托。
实施例1：
钴(Co)63％、铬(Cr)29％、钼(Mo)4.5％、钛(Ti)1.1％、硅(Si)0.9％、铁(Fe)0.8％、锰(Mn)0.4％和碳(C)0.3％。本实施例的齿科用支架钢合金材料经真空熔炼和真空浇铸后所得到的齿科用支架钢的安全性及物理性能由表1所示，所述的安全性是指生物学测试结果。
实施例2：
钴(Co)64％、铬(Cr)30％、钼(Mo)4.2％、钛(Ti)0.6％、硅(Si)0.5％、铁(Fe)0.3％、锰(Mn)0.3％和碳(C)0.1％。本实施例的齿科用支架钢合金材料经真空熔炼和真空浇铸后所得到的齿科用支架钢的安全性及物理性能由表1所示，所述的安全性是指生物学测试结果。
实施例3：
钴(Co)63.5％、铬(Cr)29.5％、钼(Mo)4.8％、钛(Ti)1.0％、硅(Si)0.4％、铁(Fe)0.4％、锰(Mn)0.3％和碳(C)0.1％。本实施例的齿科用支架钢合金材料经真空熔炼和真空浇铸后所得到的齿科用支架钢的安全性及物理性能由表1所示，所述的安全性是指生物学测试结果。
表1所示为由本发明的实施例1-3所得到的齿科用支架钢合金材料制成齿科用支架钢的测试结果。
Figure G2009102341300D0000031
上表即表1中的标准条款所指的标准为中国江苏省医疗器械注册产品标准YZB/苏0571-2009；上表中的1#～3#是指由实施例1-3所得到的齿科用支架钢合金材料经真空熔炼及真空浇铸后所得到的齿科用支架钢的抽检样品。其中材料成份是由南京大学现代分析中心提供报告，口腔粘膜刺激试验是由国家食品药品监督管理局济南医疗器械质量监督检验中心提供检测报告(检测报告号：Y2009022610)。表1中的检测结果是由中国江苏省医疗器械检验所作出的(检验报告<2009>ZC类第651号)。此外，本申请人还将同样由上述实施例1-3所得到的齿科用支架钢合金材料经真空熔炼及真空浇铸后所得到的齿科用支架钢取样送交中国江苏省苏州大学放射医学研究所检验检测中心检测(检测报告号：SDFY-2009-20358号，检测项目为生物相容性试验)，检验结果均印证了该合金材料无迟发性接触性致敏反应。
由上述实施例1至3的齿科用支架钢合金材料制成的齿科用支架钢的物理性能与德国BEGO Wironit牌号的齿科用支架钢相比较的数据由表2所示。
表2：
Figure G2009102341300D0000041
从上述表1和表2可知，本发明提供的齿科用支架钢合金材料具有理想的安全性和优异的物理性能<产品注册证号：苏食药监械(准)字2009第2630602号>，完全可以与被公认为国际著名品牌的德国BEGO Wironit合金相提并论。

Claims (1)

1.一种齿科用支架钢合金材料，其特征在于其化学元素及重量百分比为：钴62％-64％、铬28％-30％、钼4％-5％、钛0.3％-1.2％、硅0.2％-1.3％、铁0.2％-1.0％、锰0.2％-1.3％和碳0.1％-1.2％。
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Cited By (5)

* Cited by examiner, † Cited by third party
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CN102021365A (zh) * 2010-12-30 2011-04-20 许正诚 一种钴铬合金
CN102021520A (zh) * 2010-12-30 2011-04-20 许正诚 一种真空离子镀膜工艺
CN102978446A (zh) * 2012-11-07 2013-03-20 洛阳北苑特种陶瓷有限公司 一种用于烤瓷牙钴铬基合金及其制备方法
CN103060617A (zh) * 2012-12-26 2013-04-24 北京融点金属有限公司 一种高耐磨性能的钴铬钼合金
CN114540669A (zh) * 2022-02-22 2022-05-27 东莞理工学院 一种用于戒指环的钴铬合金及其制备方法

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1096547A (zh) * 1993-06-16 1994-12-21 张锡忠 齿科用机械性能可调铸造合金及其热处理工艺

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102021365A (zh) * 2010-12-30 2011-04-20 许正诚 一种钴铬合金
CN102021520A (zh) * 2010-12-30 2011-04-20 许正诚 一种真空离子镀膜工艺
CN102021520B (zh) * 2010-12-30 2012-09-19 许正诚 一种真空离子镀膜工艺
CN102978446A (zh) * 2012-11-07 2013-03-20 洛阳北苑特种陶瓷有限公司 一种用于烤瓷牙钴铬基合金及其制备方法
CN103060617A (zh) * 2012-12-26 2013-04-24 北京融点金属有限公司 一种高耐磨性能的钴铬钼合金
CN114540669A (zh) * 2022-02-22 2022-05-27 东莞理工学院 一种用于戒指环的钴铬合金及其制备方法

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