CN104826114B - 用于牙髓的包含纳米粒子的冲洗液 - Google Patents
用于牙髓的包含纳米粒子的冲洗液 Download PDFInfo
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- CN104826114B CN104826114B CN201510047984.3A CN201510047984A CN104826114B CN 104826114 B CN104826114 B CN 104826114B CN 201510047984 A CN201510047984 A CN 201510047984A CN 104826114 B CN104826114 B CN 104826114B
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Abstract
本发明提出第一和第二制剂的成套产品，所述第一和第二制剂旨在在牙髓治疗之前或期间进行混合以形成牙髓冲洗液。第一制剂包含氧化剂。第二制剂包含经过处理以便减缓氧化剂对其氧化的抗菌纳米粒子。抗菌纳米粒子例如以混合核‑壳结构被包覆在壳内。在一种变型中，抗菌纳米粒子由至少两种元素的合金制成，其中一种元素比另一种元素更耐氧化。
Description
技术领域
本发明涉及用于牙髓(endodontics)的冲洗液。
背景技术
在牙髓治疗过程中，牙医在每次充填操作之后使用冲洗液对根管进行清洗和消毒。事实上，利用机械化或非机械化挫对根管进行器械处理阶段产生大量碎屑，所述碎屑连同有机组织一起构成牙质淤渣(sludge)。堵塞牙本质小管的该薄层在闭合根管的最终步骤之前必须被移除。当前的现有技术建议在每次充填操作之后用次氯酸钠(NaOCl)系统的漱洗，随后用EDTA(乙二胺四乙酸)进行最终的清洗，其中这两种冲洗液因为一个抵消另一个的作用而不能被同时使用。
号为AU 2012100480 A4的澳大利亚专利申请提出另一冲洗液，其包含乙醇、烧碱(soda)(氢氧化钠)和抗菌纳米粒子(诸如银、锌或金的纳米粒子)。
实际上银纳米粒子因为其抗菌性能而在医学领域内是众所周知的。似乎当银纳米粒子溶解且Ag+离子被释放时产生所述银纳米粒子的抗菌作用。在一般情况下，允许银纳米粒子溶解的氧化剂是溶解在水中的分子氧。
在所引用的澳大利亚专利申请中所提出的冲洗液是基于银离子的释放这一原理。但并不清楚地明白纳米粒子在溶液中的溶解如何得以实现。在配方中氢氧化钠的存在和所得到的碱性pH有利于氧化银的形成，这实际上抑制这些纳米粒子的氧化以及因此抑制它们的溶解，如由附图1中的图所示。这导致纳米粒子在牙髓治疗的过程中以及甚至可能此后的作用处于较低的水平。
发明内容
本发明的目的是要提出用于牙髓的包含纳米粒子的冲洗液，其中可以调节所述纳米粒子的预期使用期限，以便例如：
-相当于牙髓治疗的持续时间，即约30至60分钟，以便在整个所述治疗过程中具有较强的消毒作用；或者
-长于牙髓治疗的持续时间，使得某些部分氧化的粒子可以保留在根管内，并且在继治疗之后的数个小时、甚至数天期间产生很强的杀菌作用。
为此目的，本发明提供第一和第二制剂的成套产品(set)，所述第一和第二制剂旨在在牙髓治疗之前或期间进行混合以形成牙髓冲洗液，第一制剂包含氧化剂，第二制剂包含经过处理以便减缓氧化剂对其氧化的抗菌纳米粒子。
因此在本发明中也可操纵两个参数，所述两个参数由氧化剂的量和通过抗菌纳米粒子的处理所赋予的保护组成，以便以相对精确的方式调节纳米粒子的预期使用期限即其溶解速率。抗菌纳米粒子的氧化在第一和第二制剂混合之后开始，导致发挥抗菌作用的离子的逐步释放。可选择上述两个参数以在整个牙髓治疗期间获得较强的消毒效果和/或长期效果。
根据一个具体的实施例，抗菌纳米粒子被包覆在壳内并因此与所述壳形成混合的核-壳结构。
抗菌纳米粒子例如是由银、金、二氧化钛、氧化铜、氧化锌或壳聚糖制成。
壳例例如是由二氧化硅、二氧化钛、氧化锆或聚合物制成。
壳优选是多孔的，更优选是介孔的。
壳有利地在其表面上包括接枝的官能团。
氧化剂例如是过氧化物、次氯酸盐、卤素、高锰酸盐、高氯酸盐或高碘酸盐。
在一个具体的实施例中，氧化剂是过氧化氢。
所述第一制剂可进一步包含螯合剂，例如马来酸、柠檬酸、乙二胺四乙酸、苹果酸、葡糖酸、乳酸、乙醇酸、丙酸、乙酸、丙二酸、草酸、酒石酸、磷酸、上述酸的盐、或乙二胺。
第二制剂可进一步包含表面活性剂，诸如硫酸盐、磺酸盐、磷酸盐、烷基羧酸盐、烷基芳基羧酸盐、烷基醚羧酸盐、季铵盐、聚山梨醇酯或二嵌段聚合物或三嵌段聚合物。具体地，表面活性剂可以是十六烷基三甲基铵硝酸盐。
第一和第二制剂优选是如此的以至于使得它们的混合物具有酸性pH值。
所述第一制剂的组分被有利地选择使得第一制剂以独立于其在抗菌纳米粒子上的氧化作用的方式发挥其在牙质上的清洁作用。
为了如上所述的同样目的，本发明还提出第一和第二制剂的成套产品，所述第一和第二制剂旨在在牙髓治疗之前或期间进行混合以形成牙髓冲洗液，第一制剂包含氧化剂，第二制剂包含由至少两种元素的合金制成的抗菌纳米粒子，其中一种元素比另一种元素更耐氧化。两种元素例如是金和银。
附图说明
-图1是针对银进行计算的电位-pH图(所谓的“Pourbaix”图)。
-图2示出被包覆在可变厚度的二氧化硅壳内的银纳米粒子(X：8纳米，Y：15纳米；Z：30纳米)。
-图3是示出冲洗液的吸光度作为时间函数演变的图。在该图中，C1表示根据本发明的包含包覆在厚度为30nm的二氧化硅壳内的银纳米粒子的冲洗液的吸光度曲线，C2表示根据本发明包含被包覆在厚度为15nm的二氧化硅壳内的银纳米粒子的冲洗液的吸光度曲线，以及C3表示类似于曲线C1和C2的那些冲洗液、但其银纳米粒子裸露(即未被包覆在壳内)的冲洗液的吸光度曲线。
-图4是示出其它冲洗液的吸光度作为时间函数演变的图。在该图中，C1'表示根据本发明的变型包含被包覆在厚度为30nm的二氧化硅壳内的银纳米粒子的冲洗液的吸光度曲线，C2'表示根据本发明所述变型的包含被包覆在厚度为15nm的二氧化硅壳内的银纳米粒子的冲洗液的吸光度曲线，以及C3'表示类似于曲线C1'和C2'的那些冲洗液、但其银纳米粒子裸露的冲洗液的吸光度曲线。
-图5示出在对根管进行器械处理之后未经冲洗的覆盖根管壁的牙质淤渣。
-图6示出在对根管进行器械处理之后用根据本发明冲洗液进行冲洗的根管壁。
具体实施方式
根据本发明的牙髓冲洗液是通过混合两种制剂A和B来获得，两种制剂A和B优选为液体溶液、优选水性溶液的形式。溶液A包含氧化剂和螯合剂。溶液B包含具有核-壳结构的混合纳米粒子和表面活性剂。“纳米粒子”在本发明范围内理解成具有的直径小于1000纳米、通常在5至1000纳米之间的粒子。在其本身已知的方式，具有核-壳结构的混合纳米粒子包括被包覆在壳内的所谓“核”纳米粒子。根据合成的条件，可能是一个或多个核纳米粒子被被包覆在单个壳内，如图2中所示。该同一图2示出壳的厚度是可变的。根据纳米粒子的形成条件，壳可具有更大或更小的厚度，以控制核粒子的溶解速率，如将在下文中解释说明的那样。
根据本发明的优选实施例，氧化剂是过氧化氢(或含氧水)，螯合剂是马来酸，所述混合纳米粒子包括银核纳米粒子和二氧化硅壳的纳米粒子(Ag@SiO2)，以及表面活性剂是CTAN(十六烷基三甲基铵硝酸盐)。
当溶液A和B混合时，过氧化氢(H2O2)将纳米粒子的金属银Ag0氧化以便释放银离子Ag+，由于冲洗液A+B的酸性pH，该物质是稳定的。在银纳米粒子周围形成的二氧化硅壳可以保护这些纳米粒子并减缓银离子的释放，否则所述银离子将仅在几十秒内就被释放。氧化剂、过氧化氢和银纳米粒子周围的保护壳的组合允许控制银的溶解动力学，使得例如溶解在对应于牙髓治疗的持续时间(通常为约30至60分钟)的时段中或在较长的时段中发生。一旦银纳米粒子被氧化，通过钝化银纳米粒子并防止氧化银的形成，马来酸通过其螯合作用而有助于使得银纳米粒子溶解。最后，CTAN使得银纳米粒子分散，从而也促进其溶解。
除了其如所上述的功能之外，在用根据本发明的冲洗液对根管进行冲洗的期间，过氧化氢和马来酸在牙质上发挥清洁作用以及在牙质淤渣上发挥移除作用。更确切地，酸和氧化介质允许无机残留物(具体是羟基磷灰石)和有机残留物(具体是坏死组织和细菌生物膜)的溶解。此外，CTAN使得二氧化硅成为介孔的，并且还通过其清洗作用参与根管的清洁。纳米粒子在冲洗液中的存在也使得能够实现磨蚀作用，这增加移除牙质淤渣的功效。
因此，所提出的牙髓冲洗液发挥两种不同的作用：
-溶液A+B基于各种组分的氧化、酸、螯合、洗涤和磨蚀性质而由此允许即刻清洁；
-溶液A允许银纳米粒子溶解以便被激活，这有利于它们的杀菌作用。它们周围的二氧化硅壳的存在使得所述二氧化硅壳可控制银纳米粒子的溶解速率，以便使其与牙髓治疗的持续时间相配。图3示出冲洗液A+B的吸光度的逐步减少(参见曲线C1：其中所述Ag@SiO2纳米粒子具有厚度为30纳米的SiO2壳的溶液；曲线C2：其中所述Ag@SiO2纳米粒子具有厚为15纳米的SiO2壳的溶液)，从而银纳米粒子逐步溶解。通过对比的方式，图3示出无壳的银纳米粒子的溶解是非常快速的，并且与牙髓治疗的持续时间不相配(参见曲线C3)。
因此，本发明的一个特征在于下述事实，即允许根管即刻清洁的试剂同样是允许银纳米粒子溶解的那些试剂。
在如上所述的本发明中，所述银纳米粒子的逐步溶解可能是由于下述事实，即使用酸-氧化剂介质，其中Ag+离子在溶液中是稳定的(参见图1)。然而还可考虑使得银离子稳定的其它手段，例如通过存在高浓度的Cl-离子或通过存在氨或胺。图4示出在本发明这种变型中的吸光度曲线C1'，C2'，C3'，其中溶液A包含过氧化氢、和硝酸铵而不是马来酸。溶液的pH值从而接近7，而银(+1)物质由于形成Ag(NH3)n +络合物而在溶液中是稳定的。在该图4中可以看出，标记实际溶解开始的拐点位于在溶液A和B混合之后的相同时长(对于厚度为15纳米的壳而言为50秒，以及对于30纳米的壳而言为250秒)，如在图3中的情况下那样。这种混合由于更有效地溶解纳米粒子，溶解速率因此更高。这证明银纳米粒子周围的二氧化硅壳具有减缓所述银纳米粒子溶解的作用，不管选择溶解它们的溶液是什么，都是这种情况。
除了限制抗菌纳米粒子的溶解速率之外，二氧化硅壳也可以用作官能团接枝的界面。事实上，将基团接枝到裸露的抗菌纳米粒子(通常为银)上包括将基团直接固定到纳米粒子的表面原子上，例如通过硫醇官能。存在这种官能化可显著改变纳米粒子的反应性，因而特别是改变它们的溶解速率。此外，由于发生纳米粒子的溶解，接枝的基团将变为从所述纳米粒子表面分离，从而会失去其作用。由于这些原因，优选地在所述抗菌纳米粒子周围提供界面层，可在界面层上接枝官能团并且在纳米粒子的溶解过程中所述界面层是相对稳定的。
由于二氧化硅在冲洗液条件下的稳定性和允许官能化的大量选择的容易获得的有机硅烷的多样性，从而二氧化硅构成用于产生该界面层的理想材料。其它材料和接枝手段仍然是可以设想的。这种官能化预期改变纳米粒子的物理或化学表面特性以便改变其行为。
接枝基团可以是：
-小的官能团(磺酸盐、铵等)，用于改变所述纳米粒子的表面电荷，从而改变其对于带相反电荷表面(诸如牙质表面)的亲和力；
-小的官能团(烷基、苯基、醇等)，用于改变纳米粒子的疏水性/亲水性性质；
-小的官能团(羧酸盐、膦酸盐、硫醇、胺等)，用于给纳米粒子提供针对一种特定类型的表面的更大的亲和力；
-聚合物链(例如，聚乙二醇)，其可变成与生物聚合物缠结，从而优先地提高对细菌生物膜(粘膜粘附机构)的粘合性；
-特定的小分子，其能够与给定的分子受体相互作用，并从而在这些受体的附近固定纳米粒子；
-肽或蛋白质，其可结合到具体的对象(例如，在细菌膜中)，从而允许抗菌纳米粒子的精确选址。
通常而言，在溶液A中，过氧化氢以0.1质量％至30质量％的水平存在，优选以约6％的水平存在，而马来酸以1质量％至60质量％的水平存在，优选以约12％的水平存在。
在溶液B中，其可具有与溶液A相同的体积，Ag@SiO2混合纳米粒子的量通常在10毫克/升和10000毫克/升之间，并优选等于约400毫克/升(约300毫克/升的银和约100毫克/升的二氧化硅)，以及CTAN的质量比例通常为0.1％至2.5％，且优选等于约0.5％。所述银纳米粒子的直径通常在5纳米和250纳米之间，优选等于约30纳米。二氧化硅壳的厚度通常在2纳米至100纳米之间。
在实践中，溶液A和溶液B可包含在两个单独的容器中，以试剂盒的形式提供给牙医。溶液A和溶液B也可以包含在单个容器的两个单独的隔室中。溶液A随着时间的推移是稳定的。溶液B随着时间的推移也是稳定的，只要在不与氧气接触的条件下进行存储即可。
在牙髓治疗之前或期间，牙医将两种溶液A和B混合以形成冲洗液，牙医在使用各种器械对其处理之后将用该冲洗液冲洗根管。也可在喷射系统的管内实施溶液A和B的混合。混合两种溶液A和B使得纳米粒子与氧化剂接触，从而激活银的抗菌作用，由于减缓银纳米粒子溶解的二氧化硅壳，抗菌作用在整个牙髓治疗期间持续。相比于银离子，银和二氧化硅纳米粒子与牙齿表面具有良好的亲和性并容易附着到其上。在牙髓治疗结束时闭合根管。一些部分氧化的银纳米粒子将能够保留在从而闭合的根管内并在手术后的数天继续发挥它们的消毒作用。通过银离子的释放和扩散将允许实现消毒作用，包括在不直接进行器械处理的根管的部分内。
通过示例的方式，图5示出在对所述根管进行器械处理之后未经冲洗的覆盖根管壁的牙质淤渣。图6示出在对所述根管进行器械处理之后用根据本发明的溶液A+B进行冲洗的根管壁。应当指出的是，牙质淤渣已经被移除，并且牙质小管是开放的且未被侵蚀。在每次充填操作之后使用且还用作最终冲洗液的根据本发明的冲洗液允许有效地清洁根管表面。溶液B的银纳米粒子可以其本身已知的方式例如从硝酸银和柠檬酸钠来获得。
二氧化硅壳可从APTES(3-氨丙基三乙氧基硅烷)和TEOS(正硅酸四乙酯)来获得。TEOS形成二氧化硅基体的最大部分。APTES有助于将二氧化硅结合到银表面上(通过形成Ag-NH2R键)。通过调节TEOS和APTES的量，可调节二氧化硅壳的厚度，通常在2和100纳米之间。可以具有多个二氧化硅壳尺寸(通过制备多批并将它们混合)，以便控制并使得溶解动力学“平缓(flatten)”。因此，覆盖有较薄二氧化硅层的银纳米粒子的部分将具有短期的消毒效果而覆盖有较厚二氧化硅层的银纳米粒子的另一部分将具有长期的效果。
其它添加剂可用于合成所述Ag@SiO2混合粒子。例如，甘油使得获得银核粒子的更好单分散性成为可能。
在本发明的变型中，其它氧化剂可作为过氧化氢的替代品或除了过氧化氢之外另外使用，例如，另一种过氧化物、次氯酸盐、双卤素(di-halogen)、高锰酸盐、高氯酸盐和/或高碘酸盐。类似地，其它螯合剂可作为马来酸的替代品或除了马来酸之外另外使用，例如，柠檬酸、乙二胺四乙酸、苹果酸、葡糖酸、乳酸、乙醇酸、丙酸、乙酸、丙二酸、草酸、酒石酸、磷酸、上述酸的盐或乙二胺。卤素离子(I-、Br-、F-)也可用于掺入到氧化物层内以及用于促进所述银纳米粒子的溶解。最后，CTAB(十六烷基三甲基溴化铵)可代替CTAN或添加到CTAN。然而，CTAN优于CTAB，因为在银存在的条件下溴离子可形成AgBr沉淀，其是高度不可溶的，这将降低其可用性。在一般情况下，表面活性剂可以是阴离子型(诸如硫酸盐，磺酸盐，磷酸盐，烷基、烷基芳基或烷基醚羧酸盐)，阳离子型(诸如季铵盐)，两性离子型或非离子型(诸如聚山梨酯或二嵌段聚合物或三嵌段聚合物)的。
如上所解释说明的那样，银纳米粒子以核-壳结构被包覆在二氧化硅纳米粒子内以便减缓氧化剂对它们的氧化。壳材料可以是二氧化硅之外的材料，例如，二氧化钛、氧化锆或聚合物涂层。抗菌核材料可以是银之外的材料，例如金、二氧化钛、氧化铜、氧化锌或壳聚糖。
也可以通过以除了将它们被包覆在壳内之外的另一种方式处理他们来减缓抗菌纳米粒子的氧化。例如，通过在抗菌纳米粒子的表面上形成具有较差溶解度的化合物(例如溴化银或硫化银)来钝化抗菌纳米粒子的表面将是可行的。在变型中，以合金(例如金/银合金)的方式制备抗菌纳米粒子将是可能的，合金由于其元素之一更耐氧化而更耐氧化。
最后，代替为液体溶液的形式，制剂A和B中的至少之一可以是固体，例如为粉末的形式。如果两种制剂A和B都是固体，可以设想到牙医自己将它们溶解在水中或其它液体中。
Claims (11)
1.第一制剂和第二制剂的成套产品，所述第一制剂和第二制剂旨在在牙髓治疗之前或期间进行混合以形成牙髓冲洗液，所述第一制剂包含氧化剂，所述第二制剂包含被包覆在介孔的壳内的抗菌纳米粒子，其中，当所述第一制剂和第二制剂混合时，所述氧化剂氧化所述抗菌纳米颗粒，所述介孔的壳用于减缓所述氧化剂对所述抗菌纳米颗粒的氧化，从而导致发挥抗菌作用的离子的逐步释放，
其中所述抗菌纳米粒子由银、金、二氧化钛、氧化铜、氧化锌或壳聚糖制成，
其中所述介孔的壳由二氧化硅、二氧化钛、氧化锆或聚合物制成，以及
其中所述氧化剂是过氧化物、次氯酸盐、卤素、高锰酸盐、高氯酸盐或高碘酸盐。
2.根据权利要求1所述的成套产品，其特征在于，所述介孔的壳包括在其表面上接枝的官能团。
3.根据权利要求1所述的成套产品，其特征在于，所述氧化剂是过氧化氢。
4.根据权利要求1至3任一项所述的成套产品，其特征在于，所述第一制剂进一步包含螯合剂。
5.根据权利要求4所述的成套产品，其特征在于，所述螯合剂是马来酸、柠檬酸、乙二胺四乙酸、苹果酸、葡糖酸、乳酸、乙醇酸、丙酸、乙酸、丙二酸、草酸、酒石酸、磷酸、上述酸的盐、或乙二胺。
6.根据权利要求1至3任一项所述的成套产品，其特征在于，所述第二制剂进一步包含表面活性剂。
7.根据权利要求6所述的成套产品，其特征在于，所述表面活性剂是硫酸盐、磺酸盐、磷酸盐、烷基羧酸盐、烷基芳基羧酸盐、烷基醚羧酸盐、季铵盐、聚山梨醇酯或二嵌段聚合物或三嵌段聚合物。
8.根据权利要求6所述的成套产品，其特征在于，所述表面活性剂是十六烷基三甲基铵硝酸盐。
9.根据权利要求1至3任一项所述的成套产品，其特征在于，所述第一制剂和第二制剂是如此的以至于使得它们的混合物具有酸性pH。
10.根据权利要求1至3任一项所述的成套产品，其特征在于，所述第一制剂的组分选择成使得所述第一制剂以独立于其在所述抗菌纳米粒子上的氧化作用的方式发挥其在牙质上的清洁作用。
11.第一制剂和第二制剂的混合物，所述第一制剂和第二制剂是如前述权利要求任一项中所限定的第一制剂和第二制剂。
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| US10960129B2 (en) | 2017-08-25 | 2021-03-30 | AZ Solutions LLC | System and method for patient skin treatment and irrigation |
| BR112020003793A2 (pt) * | 2017-08-25 | 2020-10-13 | AZ Solutions LLC | método para irrigar uma ferida, método de supressão de infecção e sistema de irrigação de ferida |
| US11918549B2 (en) | 2017-08-25 | 2024-03-05 | AZ Solutions LLC | System and method for wound treatment and irrigation |
| GB2590245B (en) * | 2018-06-21 | 2023-04-12 | Advantage Silver Dental Arrest Llc | Encapsulated antimicrobials and related methods of treatment |
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| US6548264B1 (en) * | 2000-05-17 | 2003-04-15 | University Of Florida | Coated nanoparticles |
| EE05508B1 (et) * | 2005-01-05 | 2012-02-15 | Robert@Holladay | H be/vesi h beda geelid ja h bedap hised kompositsioonid; nende valmistamise ja kasutamise meetodid |
| US7511007B2 (en) * | 2005-02-25 | 2009-03-31 | Solutions Biomed, Llc | Aqueous sanitizers, disinfectants, and/or sterilants with low peroxygen content |
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| WO2010071831A2 (en) * | 2008-12-19 | 2010-06-24 | The Regents Of The University Of California | Structured silver-mesoporous silica nanoparticles having antimicrobial activity |
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| AU2012100480A4 (en) | 2012-04-26 | 2012-06-07 | Leila Moghadas | Composition and method for irrigation of dental root canal |
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| DE202008009873U1 (de) * | 2008-07-22 | 2008-10-02 | Kettenbach Gmbh & Co. Kg | Dentale Bleichmittelzusammensetzung und Dentallack |
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