Lithium disilicate (Li2Si2O5) glass‐ceramics are currently a more widely used all‐ceramic restorative material due to their good mechanical properties and excellent aesthetic properties. However, they have a series of problems such as high brittleness and low fracture toughness, which has become the main bottleneck restricting its development. Therefore, in order to compensate for these shortcomings, we propose to prepare a reinforced glass‐ceramics with better mechanical properties and to test the biosafety and chemical solubility of the material. Li2Si2O5 whiskers were synthesized by a one‐step hydrothermal method, and multi‐scale crystal‐enhanced Li2Si2O5 glass‐ceramics were prepared by reaction sintering. The biosafety of multi‐scale crystal‐reinforced Li2Si2O5 glass‐ceramics was investigated by in vitro cytotoxicity test, rabbit pyrogen test, mice bone marrow micronucleus test, skin sensitization test, sub‐chronic systemic toxicity test, and chronic systemic toxicity test. Additionally, the chemical solubility of multi‐scale crystal‐reinforced Li2Si2O5 glass‐ceramics was investigated. The test results showed that the material was non‐cytotoxic, non‐thermogenic, non‐mutagenic, non‐sensitizing, and non‐systemic. The chemical solubility, determined to be 377 ± 245 μg/cm2, complied with the ISO 6872 standard for the maximum solubility of ceramic materials. Multi‐scale crystal‐reinforced Li2Si2O5 glass‐ceramics' biosafety and chemical solubility met current normative criteria, and they can move on to mechanical property measurements (such as flexural strength test, fatigue life test, friction and wear property study, etc.) and bonding property optimization, which shows promise for future clinical applications.

中文翻译：

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多尺度晶体增强二硅酸锂玻璃陶瓷的生物安全性和化学溶解度研究

二硅酸锂（Li2硅2氧5）微晶玻璃因其良好的机械性能和优异的美观性能，是目前应用较为广泛的全瓷修复材料。但它们存在脆性高、断裂韧性低等一系列问题，成为制约其发展的主要瓶颈。因此，为了弥补这些缺点，我们建议制备具有更好机械性能的强化微晶玻璃，并测试该材料的生物安全性和化学溶解性。李2硅2氧5通过一步水热法合成了晶须，并制备了多尺度晶体增强锂2硅2氧5采用反应烧结法制备微晶玻璃。多尺度晶体增强锂的生物安全性2硅2氧5通过体外细胞毒性试验、兔热原试验、小鼠骨髓微核试验、皮肤致敏试验、亚慢性全身毒性试验、慢性全身毒性试验对微晶玻璃进行了研究。此外，多尺度晶体增强锂的化学溶解度2硅2氧5对微晶玻璃进行了研究。测试结果表明，该材料无细胞毒性、无致热性、无致突变性、无致敏性、非全身性。化学溶解度测定为 377 ± 245 μg/cm2，符合陶瓷材料最大溶解度的ISO 6872标准。多尺度晶体增强Li2硅2氧5微晶玻璃的生物安全性和化学溶解性符合现行规范标准，可以进行力学性能测量（如弯曲强度测试、疲劳寿命测试、摩擦磨损性能研究等）和粘结性能优化，具有广阔的应用前景以供将来的临床应用。