首饰用不锈钢等的镍释放及抗菌改性
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摘要
首饰在佩戴过程中暴露出来的金属镍过敏、带菌感染等安全问题越来越普遍，损害了消费者的身心健康。金属首饰作为与人体皮肤长时间直接接触的或者植入组织的装饰品，与冶金工程、材料和生物医学工程学科都有密切的关系。本文在对首饰市场上常见的首饰材料及生产工艺进行前期调研的基础上，以首饰用不锈钢材料为主线，从生物材料和冶金工程的角度，开展了不锈钢等金属首饰材料的镍释放试验、S316L不锈钢的抗菌改性试验以及高氮无镍抗菌不锈钢的试验等三个方面的研究，以便为解决首饰镍过敏、带菌感染问题，以及首饰金属材料的选择、研发及应用提供指导意见。
选择使用最广泛的不锈钢、白铜、镍K白金、镀镍层等含镍首饰材料作为镍释放研究对象，采用首饰常用的各种处理工艺对试样进行处理，采用镍释放标准试验方法检测各材料在不同生产工艺下的镍释放水平。试验确定了不同生理环境、成型方法、表面处理方法、热处理工艺对不锈钢等含镍首饰材料镍释放率的影响规律，阐明须根据具体条件评价材料镍释放率及致敏风险。研究发现镍释放率与镍含量没有严格对应关系，材料的夹杂物和冷变形会促进镍释放，且冷变形态的镍释放率呈现各向异性，采取适当的热处理可使镍释放率降低。材料表面越粗糙，镍释放率越高，镀镍层可明显提高镍释放率。S316L不锈钢在不同生理溶液中的镍释放率呈现“人工体液>人工汗液>尿液>人工唾液”的顺序。
指出BZn10-25镍白铜、S201和S303不锈钢、镍漂白18K和10K材料在各种状态的实际镍释放率均明显超过了镍指令规定的阈值，存在镍致敏风险，尤其是BZn10-25和S303不锈钢的风险极大。固溶态的S316L不锈钢型材经镜面抛光后，其实际镍释放率很低，对绝大部分人员应可安全使用，不至于有镍致敏风险，但是当它处于冷变形态、铸态、退火态、喷砂态、推砂态等条件下，其释放率有不同程度的增加，尤其是当出现两种或数种促进镍释放的因素叠加在一起，镍释放率达到或超过镍指令规定的阈值，长期使用时不排除有引起镍过敏的风险。指出要彻底回避镍过敏风险，研发无镍材料和工艺是必由之路。
针对普通不锈钢不具抗菌性能的问题，选择对S316L不锈钢进行抗菌改性，采用覆膜法进行抗菌试验。针对含铜不锈钢需要在敏化区间抗菌化时效处理存在的不足，采用在不锈钢基底中固溶度微小的适量铈/镧、银作为抗菌剂，并通过综合细晶化措施，直接获得了抗菌性能而无需时效处理。根据试验结果提出了铈/镧、银改性不锈钢的抗菌机理，它们与细菌接触一定时间，从富集相中释放出铈/镧或银离子，这些离子在静电吸附作用下被吸附在细胞壁表面，对细菌细胞壁和蛋白作用而产生抗菌功效。
研究发现铈、镧改性S316L不锈钢对金黄色葡萄球菌和大肠杆菌呈现Hormesis效应，铈、镧只有达到一定含量才能实现抗菌功效，且含量越高，抗菌性能越好，但过多的铈、镧会损害加工性能和耐蚀性能，增加材料的镍释放率。指出单一采用铈或者镧对S316L不锈钢进行改性时，难以保证材料同时具有优良的耐蚀性能、抗菌性能和加工性能。当铈或镧含量在0.15~0.2wt%时，这些性能之间可获得相对较好的折衷。
研究发现在约0.1wt%铌、真空熔炼、加快凝固速度等综合细晶化作用下，银含量在0.04~0.06wt%时以细小富银相弥散分布在基体中，使含银不锈钢对金黄色葡萄球菌和大肠杆菌产生了优良的抗菌性能，且不会因为重复使用和磨损而减弱。发现含银不锈钢改善了在微生物环境中的耐蚀性，但银含量过高时会损害不锈钢在非微生物环境中的耐蚀性，并略微提高不锈钢的镍释放率。
针对S316L不锈钢抗菌改性后可能出现的镍过敏风险，提出了首饰用高氮无镍奥氏体不锈钢的选材原则，在此基础上确定了试验用钢00Cr18Mn18Mo2N0.55。发现该钢在非微生物环境中具有优异的抗点蚀性能，但是与菌液接触时会在表面形成发达的生物被膜，明显促进细菌的生长繁殖，并诱发微生物腐蚀，阐明了导致粘附严重的根本原因是高氮不锈钢为细菌的附着生长提供了一个营养丰富的基底。指出高氮无镍不锈钢不适合用于微生物环境中，并选择铜和银对其进行抗菌改性。
研究发现含铜约3.5wt%的00Cr18Mn18Mo2N0.55不锈钢经800℃时效1h后可改善细菌粘附状况，但抗菌性能较弱，同时析出的氮化铬会明显损害耐蚀性，时效时间越长，耐蚀性受损越严重，指出开发高氮无镍抗菌不锈钢时不适合选择铜作为抗菌元素。发现00Cr18Mn18Mo2N0.55不锈钢中需要比在S316L中更高的银含量才能获得抗菌功效，提出这是银抗菌和氮促菌相互竞争、形成起缓释作用的银氨络离子以及锰改善银在基体的固溶等几方面综合作用的结果。设计研发出含银0.13~0.15wt%的00Cr18Mn18Mo2N0.55不锈钢，该钢在微生物环境中可阻碍细菌粘附及生物膜的发展，有较好的抗菌性能和抗微生物腐蚀性能；在非微生物环境中仍保持优良的抗点蚀性能和抗磨蚀性能，不存在镍过敏和金属毒性的风险，可以满足首饰加工要求，是综合性能优于S316L的有前景的首饰材料。
During the application of jewelries, the safety problems such as nickel allergy and bacterialinfection are becoming more and more prevalent, it damages the consumer’s physical and mentalhealth. As the decorations of long time contacting with skin or being implanted in the tissue,metal jewelries have close relationship with metallurgical engineering, materials science andbiomedical engineering discipline. Based on our earlier research of common jewelry materialsand production processes in jewelry market, stainless steel for jewelry was chosen as the mainline in this paper, and three aspects of experimental investigation were carried out from theviewpoint of biomaterial and metallurgical engineering, including the nickel release rates ofmetallic jewelry materials, the antibacterial modification of S316L stainless steel and highnitrogen nickel-free antibacterial stainless steel, so that guidance can be provided for solvingnickel allergy and bacterial infection problem, and the selection, development and application ofmetallic jewelry materials.
The most widely used nickel containing materials, including stainless steels, cupronickel,nickel bleached karat white gold and nickel plating layer, were chosen as the nickel release testobjects, the samples were treated by the common processing technology, and then their nickelrelease rates under various conditions were tested according to the nickel release standard testmethods. The effects of various physiological environment, shaping method, surface treatmentmethod and heat treatment process on nickel release rate of stainless steel and other nickelcontaining material for jewelry were determined experimentally and the mechanism wasanalyzed, and it is pointed out that the evaluation of a material’s nickel release rate and allergyrisk can not be separated from its specific conditions. It is found that there is no correspondenceof nickel release rates to nickel content, inclusions and cold deformation will promote nickelrelease, and it presents anisotropy for cold deformation, while appropriate heat treatment canreduce nickel release rate. The rougher the material surface is, the more nickel ions are released,while nickel plating layer can obviously improve nickel release rate. In different physiologicalenvironment, S316L’s nickel release rate shows the sequence as “artificial body fluid> artificialsweat> urine> artificial saliva”.
It is determined that the actual nickel release rates of BZn10-25, S201and S303stainlesssteels,10K and18K nickel bleached gold alloys under all various conditions significantly exceed the threshold specified in Nickel Directives, the allergy risks for these materials are high,especially for BZn10-25and S303. The practical nickel release rate of mirror polished S316Lstainless steel under solid solution state is very low, it should be safe and can’t go so far as toarouse nickel allergy for most people, however, when the material is under an adverse conditionssuch as cold work, as-cast, annealing, sand blasting, sand pushing, etc, its nickel release rateswill increase by different degrees, especially when two or more of these promoting factors addtogether, the actual nickel release rate will reach or exceed the specified threshold, it can notcompletely exclude the risk of nickel allergy for long term wearing. Therefore, it is pointed outthat the development of nickel-free materials and technologies is the only way to avoid nickelallergy risk thoroughly.
Since the ordinary stainless steels have no antibacterial performance, S316L was selectedfor antibacterial modification and the thin-film adhering quantitative bacteriostasis method wasused to test the antibacterial property. Aim at the question of copper bearing stainless steel agingtreated at the sensitized interval to acquire antibacterial efficacy, suitable amount of Ce/La or Agwith tiny solubility in the matrix of stainless steel were used as antibacterial agents, by means ofcomprehensive grain refining measures, the modified stainless steel acquired antibacterialperformance with no need of aging treatment. According to the experimental results, theantibacterial mechanism of Ce/La or Ag modified stainless steel is put forward, when the steelcontacts with bacteria for some time, the Ce/La or Ag ions released from the enrichment phaseare absorbed to the bacterial surface because of the electrostatic adsorption, their action on thecell wall and protein will produce antibacterial efficacy.
It is found that Ce or La modified S316L stainless steel shows Hormesis effect against S.aureus and E. coli, only when Ce or La content reaches a certain amount can the modifiedstainless steel realize antibacterial effect, The more amount of Ce or La is added, the betterantibacterial performance is achieved, however, too much amount of Ce or La will damage theprocessability and corrosion resistance, and increase nickel release rate. It is shown that theaddition of Ce or La alone in S316L is difficult to obtain the optimal combination of corrosionresistance, antibacterial capability and processability, and0.15~0.2wt%Ce or La is suggested tobe the trade-off for the best overall performance.
Through the comprehensive grain refining measures, including vaccum arc melting, water-cooled copper crucible to accelerate solidification and~0.1wt%niobium,0.04~0.06wt%silver can be dispersed in the stainless steel matrix in the form of tiny Ag-rich phase, themodified stainless steel shows excellent antibacterial efficacy against S. aureus and E. coli, and itwill not abate after repetitive use and wear. It is found that silver modified stainless steel hasbetter corrosion resistance in microbial environment, however, too much silver will degrade thecorrosion resistance in non-microbial environment, and nickel release rate will slightly increasealso.
In view of the possible risk of nickel allergy for S316L stainless steel after beingantibacterial modified, the material selection principle of high nitrogen nickel-free stainless steelfor jewelry was put forward and the experimental material00Cr18Mn18Mo2N0.55wasdetermined based on it. The material has excellent pitting corrosion resistance in non-microbialenvironment, however, well-developed biofilm will form on its surface when it contacts withbacterial suspension, and the bacterial growth is obviously promoted, inducing microbiologicalcorrosion. The root cause of bacterial serious adhesion is inferred to be that high nitrogenstainless steel provides a rich nutritional basement for bacteria growth. It is suggested that highnitrogen stainless steel is not suitable for microbial environment unless after antibacterialmodification. Copper and silver were selected as the antibacterial agents. It is found that thebacterial adhesion on00Cr18Mn18Mo2N0.55stainless steel containing about3.5wt%Cu can beimproved after aging treatment at800℃for one hour, but the sterilization efficacy is weak, andthe precipitated Cr2N will degrade its corrosion resistance, the longer the aging time, the moreserious the damage to corrosion resistance. It is determined that copper is unsuitable asantibacterial agent in high nitrogen stainless steel. Higher silver content is needed in00Cr18Mn18Mo2N0.55to realize sterilization efficacy than in S316L and it is presumed to bethe comprehensive effect of competition result of silver’s sterilizing bacteria and nitrogen’spromoting bacterial growth, slow-release function of silver ammino ions and manganeseimproving the solubility of silver in the matrix.00Cr18Mn18Mo2N0.55containing0.13~0.15wt%silver is designed and developed, this modified material has relatively goodantibacterial property, it can hinder bacterial adhesion and biofilm development, and improvemicrobiological corrosion resistance, it still keeps excellent pitting corrosion resistance andcorrosion wear resistance in non-microbiological environment, and it has no risk of nickel allergy and metal toxicity and can meet the processing requirement of jewelry, therefore it is apromising jewelry material with superior overall properties to S316L.
选择使用最广泛的不锈钢、白铜、镍K白金、镀镍层等含镍首饰材料作为镍释放研究对象，采用首饰常用的各种处理工艺对试样进行处理，采用镍释放标准试验方法检测各材料在不同生产工艺下的镍释放水平。试验确定了不同生理环境、成型方法、表面处理方法、热处理工艺对不锈钢等含镍首饰材料镍释放率的影响规律，阐明须根据具体条件评价材料镍释放率及致敏风险。研究发现镍释放率与镍含量没有严格对应关系，材料的夹杂物和冷变形会促进镍释放，且冷变形态的镍释放率呈现各向异性，采取适当的热处理可使镍释放率降低。材料表面越粗糙，镍释放率越高，镀镍层可明显提高镍释放率。S316L不锈钢在不同生理溶液中的镍释放率呈现“人工体液>人工汗液>尿液>人工唾液”的顺序。
指出BZn10-25镍白铜、S201和S303不锈钢、镍漂白18K和10K材料在各种状态的实际镍释放率均明显超过了镍指令规定的阈值，存在镍致敏风险，尤其是BZn10-25和S303不锈钢的风险极大。固溶态的S316L不锈钢型材经镜面抛光后，其实际镍释放率很低，对绝大部分人员应可安全使用，不至于有镍致敏风险，但是当它处于冷变形态、铸态、退火态、喷砂态、推砂态等条件下，其释放率有不同程度的增加，尤其是当出现两种或数种促进镍释放的因素叠加在一起，镍释放率达到或超过镍指令规定的阈值，长期使用时不排除有引起镍过敏的风险。指出要彻底回避镍过敏风险，研发无镍材料和工艺是必由之路。
针对普通不锈钢不具抗菌性能的问题，选择对S316L不锈钢进行抗菌改性，采用覆膜法进行抗菌试验。针对含铜不锈钢需要在敏化区间抗菌化时效处理存在的不足，采用在不锈钢基底中固溶度微小的适量铈/镧、银作为抗菌剂，并通过综合细晶化措施，直接获得了抗菌性能而无需时效处理。根据试验结果提出了铈/镧、银改性不锈钢的抗菌机理，它们与细菌接触一定时间，从富集相中释放出铈/镧或银离子，这些离子在静电吸附作用下被吸附在细胞壁表面，对细菌细胞壁和蛋白作用而产生抗菌功效。
研究发现铈、镧改性S316L不锈钢对金黄色葡萄球菌和大肠杆菌呈现Hormesis效应，铈、镧只有达到一定含量才能实现抗菌功效，且含量越高，抗菌性能越好，但过多的铈、镧会损害加工性能和耐蚀性能，增加材料的镍释放率。指出单一采用铈或者镧对S316L不锈钢进行改性时，难以保证材料同时具有优良的耐蚀性能、抗菌性能和加工性能。当铈或镧含量在0.15~0.2wt%时，这些性能之间可获得相对较好的折衷。
研究发现在约0.1wt%铌、真空熔炼、加快凝固速度等综合细晶化作用下，银含量在0.04~0.06wt%时以细小富银相弥散分布在基体中，使含银不锈钢对金黄色葡萄球菌和大肠杆菌产生了优良的抗菌性能，且不会因为重复使用和磨损而减弱。发现含银不锈钢改善了在微生物环境中的耐蚀性，但银含量过高时会损害不锈钢在非微生物环境中的耐蚀性，并略微提高不锈钢的镍释放率。
针对S316L不锈钢抗菌改性后可能出现的镍过敏风险，提出了首饰用高氮无镍奥氏体不锈钢的选材原则，在此基础上确定了试验用钢00Cr18Mn18Mo2N0.55。发现该钢在非微生物环境中具有优异的抗点蚀性能，但是与菌液接触时会在表面形成发达的生物被膜，明显促进细菌的生长繁殖，并诱发微生物腐蚀，阐明了导致粘附严重的根本原因是高氮不锈钢为细菌的附着生长提供了一个营养丰富的基底。指出高氮无镍不锈钢不适合用于微生物环境中，并选择铜和银对其进行抗菌改性。
研究发现含铜约3.5wt%的00Cr18Mn18Mo2N0.55不锈钢经800℃时效1h后可改善细菌粘附状况，但抗菌性能较弱，同时析出的氮化铬会明显损害耐蚀性，时效时间越长，耐蚀性受损越严重，指出开发高氮无镍抗菌不锈钢时不适合选择铜作为抗菌元素。发现00Cr18Mn18Mo2N0.55不锈钢中需要比在S316L中更高的银含量才能获得抗菌功效，提出这是银抗菌和氮促菌相互竞争、形成起缓释作用的银氨络离子以及锰改善银在基体的固溶等几方面综合作用的结果。设计研发出含银0.13~0.15wt%的00Cr18Mn18Mo2N0.55不锈钢，该钢在微生物环境中可阻碍细菌粘附及生物膜的发展，有较好的抗菌性能和抗微生物腐蚀性能；在非微生物环境中仍保持优良的抗点蚀性能和抗磨蚀性能，不存在镍过敏和金属毒性的风险，可以满足首饰加工要求，是综合性能优于S316L的有前景的首饰材料。
During the application of jewelries, the safety problems such as nickel allergy and bacterialinfection are becoming more and more prevalent, it damages the consumer’s physical and mentalhealth. As the decorations of long time contacting with skin or being implanted in the tissue,metal jewelries have close relationship with metallurgical engineering, materials science andbiomedical engineering discipline. Based on our earlier research of common jewelry materialsand production processes in jewelry market, stainless steel for jewelry was chosen as the mainline in this paper, and three aspects of experimental investigation were carried out from theviewpoint of biomaterial and metallurgical engineering, including the nickel release rates ofmetallic jewelry materials, the antibacterial modification of S316L stainless steel and highnitrogen nickel-free antibacterial stainless steel, so that guidance can be provided for solvingnickel allergy and bacterial infection problem, and the selection, development and application ofmetallic jewelry materials.
The most widely used nickel containing materials, including stainless steels, cupronickel,nickel bleached karat white gold and nickel plating layer, were chosen as the nickel release testobjects, the samples were treated by the common processing technology, and then their nickelrelease rates under various conditions were tested according to the nickel release standard testmethods. The effects of various physiological environment, shaping method, surface treatmentmethod and heat treatment process on nickel release rate of stainless steel and other nickelcontaining material for jewelry were determined experimentally and the mechanism wasanalyzed, and it is pointed out that the evaluation of a material’s nickel release rate and allergyrisk can not be separated from its specific conditions. It is found that there is no correspondenceof nickel release rates to nickel content, inclusions and cold deformation will promote nickelrelease, and it presents anisotropy for cold deformation, while appropriate heat treatment canreduce nickel release rate. The rougher the material surface is, the more nickel ions are released,while nickel plating layer can obviously improve nickel release rate. In different physiologicalenvironment, S316L’s nickel release rate shows the sequence as “artificial body fluid> artificialsweat> urine> artificial saliva”.
It is determined that the actual nickel release rates of BZn10-25, S201and S303stainlesssteels,10K and18K nickel bleached gold alloys under all various conditions significantly exceed the threshold specified in Nickel Directives, the allergy risks for these materials are high,especially for BZn10-25and S303. The practical nickel release rate of mirror polished S316Lstainless steel under solid solution state is very low, it should be safe and can’t go so far as toarouse nickel allergy for most people, however, when the material is under an adverse conditionssuch as cold work, as-cast, annealing, sand blasting, sand pushing, etc, its nickel release rateswill increase by different degrees, especially when two or more of these promoting factors addtogether, the actual nickel release rate will reach or exceed the specified threshold, it can notcompletely exclude the risk of nickel allergy for long term wearing. Therefore, it is pointed outthat the development of nickel-free materials and technologies is the only way to avoid nickelallergy risk thoroughly.
Since the ordinary stainless steels have no antibacterial performance, S316L was selectedfor antibacterial modification and the thin-film adhering quantitative bacteriostasis method wasused to test the antibacterial property. Aim at the question of copper bearing stainless steel agingtreated at the sensitized interval to acquire antibacterial efficacy, suitable amount of Ce/La or Agwith tiny solubility in the matrix of stainless steel were used as antibacterial agents, by means ofcomprehensive grain refining measures, the modified stainless steel acquired antibacterialperformance with no need of aging treatment. According to the experimental results, theantibacterial mechanism of Ce/La or Ag modified stainless steel is put forward, when the steelcontacts with bacteria for some time, the Ce/La or Ag ions released from the enrichment phaseare absorbed to the bacterial surface because of the electrostatic adsorption, their action on thecell wall and protein will produce antibacterial efficacy.
It is found that Ce or La modified S316L stainless steel shows Hormesis effect against S.aureus and E. coli, only when Ce or La content reaches a certain amount can the modifiedstainless steel realize antibacterial effect, The more amount of Ce or La is added, the betterantibacterial performance is achieved, however, too much amount of Ce or La will damage theprocessability and corrosion resistance, and increase nickel release rate. It is shown that theaddition of Ce or La alone in S316L is difficult to obtain the optimal combination of corrosionresistance, antibacterial capability and processability, and0.15~0.2wt%Ce or La is suggested tobe the trade-off for the best overall performance.
Through the comprehensive grain refining measures, including vaccum arc melting, water-cooled copper crucible to accelerate solidification and~0.1wt%niobium,0.04~0.06wt%silver can be dispersed in the stainless steel matrix in the form of tiny Ag-rich phase, themodified stainless steel shows excellent antibacterial efficacy against S. aureus and E. coli, and itwill not abate after repetitive use and wear. It is found that silver modified stainless steel hasbetter corrosion resistance in microbial environment, however, too much silver will degrade thecorrosion resistance in non-microbial environment, and nickel release rate will slightly increasealso.
In view of the possible risk of nickel allergy for S316L stainless steel after beingantibacterial modified, the material selection principle of high nitrogen nickel-free stainless steelfor jewelry was put forward and the experimental material00Cr18Mn18Mo2N0.55wasdetermined based on it. The material has excellent pitting corrosion resistance in non-microbialenvironment, however, well-developed biofilm will form on its surface when it contacts withbacterial suspension, and the bacterial growth is obviously promoted, inducing microbiologicalcorrosion. The root cause of bacterial serious adhesion is inferred to be that high nitrogenstainless steel provides a rich nutritional basement for bacteria growth. It is suggested that highnitrogen stainless steel is not suitable for microbial environment unless after antibacterialmodification. Copper and silver were selected as the antibacterial agents. It is found that thebacterial adhesion on00Cr18Mn18Mo2N0.55stainless steel containing about3.5wt%Cu can beimproved after aging treatment at800℃for one hour, but the sterilization efficacy is weak, andthe precipitated Cr2N will degrade its corrosion resistance, the longer the aging time, the moreserious the damage to corrosion resistance. It is determined that copper is unsuitable asantibacterial agent in high nitrogen stainless steel. Higher silver content is needed in00Cr18Mn18Mo2N0.55to realize sterilization efficacy than in S316L and it is presumed to bethe comprehensive effect of competition result of silver’s sterilizing bacteria and nitrogen’spromoting bacterial growth, slow-release function of silver ammino ions and manganeseimproving the solubility of silver in the matrix.00Cr18Mn18Mo2N0.55containing0.13~0.15wt%silver is designed and developed, this modified material has relatively goodantibacterial property, it can hinder bacterial adhesion and biofilm development, and improvemicrobiological corrosion resistance, it still keeps excellent pitting corrosion resistance andcorrosion wear resistance in non-microbiological environment, and it has no risk of nickel allergy and metal toxicity and can meet the processing requirement of jewelry, therefore it is apromising jewelry material with superior overall properties to S316L.
引文
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