CN114072113A - 透皮贴剂 - Google Patents
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Abstract
本发明属于医药领域，具体涉及用于吸附和去除人体内重金属和毒素颗粒的透皮贴剂。该技术成果是通过在粘合剂基体上施加一层基于氧化铁‑磁铁矿(Fe3O4)和/或磁赤铁矿(γ‑Fe2O3)的磁性纳米粒子来吸附和去除人体中的重金属颗粒。该经皮贴剂包括由织物材料制成的基底，基底上有粘合层，粘合层上有磁性基底，磁性基底上有氧化铁Fe3O4和/或γ‑Fe2O3磁性纳米颗粒层，以及设于固定渗透层上方的可撕脱材料保护层。
Description
技术领域
本发明属于医药领域，具体涉及用于吸附和去除人体内重金属和毒素颗粒的透皮贴剂。
背景技术
与重金属颗粒对人体有害影响相关的研究目前有很多[1]。重金属对生产业，如冶金行业工人的有害影响尤其普遍。
镍化合物会增加患喉癌的风险，镉化合物增加前列腺癌的风险，六价铬化合物增加鼻癌的风险，砷化合物增加皮肤癌和造血组织癌的风险，铅化合物增加胃癌、肾脏癌和膀胱癌的风险，汞化合物增加前列腺癌和肾脏癌的风险。砷皮肤癌是最早知晓的。与化学杀虫除莠剂(酒农)、兽医和医学消毒剂以及含砷矿石接触的人身上经常发生职业性和医源性的砷皮肤癌。
因为与砷接触，肺癌的发病率也增加。慢性砷中毒导致出色肿瘤(肝血管肉瘤)的发生。铬前列腺癌和铬泌尿生殖器官癌发生在染料工业、冶金、电偶、皮革工业、化学家和火柴燃烧物制造业的工人身上。
镍癌症是有色金属工业工人常患的病。与镍羰基接触患癌风险最大，镍羰基是金属净化时用的。亚硝酸盐形式的钴和钴矿粉尘的成分也具有致癌性。通常它与镍结合在一起致癌，因为镍与其是从同一矿石中提取的。
如果铍化合物(氧化物、氟化物、碳酸盐、硝酸盐)的尘沫吸入呼吸道里，也会致癌。产业致癌因素中，中铍毒后很快会患肺癌。它的潜伏期是3～4年。实验证明铍化合物可能导致(局部的和远隔的)骨原性肉瘤发生。
有实验证据表明汞、银和锌有致癌作用，这些物质会导致注射部位产生肉瘤，也有流行病学和实验证据表明氧化镉蒸气和灰尘会导致肺癌。
在香烟烟草中含有砷、镍、镉和铍，吸烟时它们(其中一些高达10％)会出现在烟草烟雾里。
纳米粒子是连接原子和体分子的中间环节，是一个很有前途的研究方向和应用领域。纳米颗粒的性质不同于分子。纳米颗粒以一维纳米结构(纳米管、纳米棒、纳米带、纳米材料、纳米凝胶、纳米线、纳米纤维、纳米球、纳米花和纳米薄片)的形式出现。
在纳米颗粒中，因其优异的磁性，纳米磁铁能占据着特殊的地位。磁性纳米粒子是广泛应用的，包括磁液体的配备、催化、生物技术/生物医学、材料科学、磁性共振成像、医学诊断、环境康复。[2]～[7]
因为在生活各个领域都有独特并富有创造性的应用，纳米颗粒的应用研究表现在研发出一系列不同尺寸、形态和成分的磁性纳米颗粒合成方法，但是在上述例子中磁性纳米颗的使用是否成功在很大程度上取决于粒子的稳定性。此外，在各个领域磁性纳米粒子的应用除了取决于其自身的磁矩和磁晶各向异性外，还取决于其粒径、表面积和形貌。
由于磁性纳米粒子的纳米尺寸，它们可以附着在细胞上，也可以进入细胞通过细胞运输，甚至可以直接进入血流。生物医学应用对粒子的性质(物理的、化学的、药理的)有严格的要求，包括化学成分、粒径、粒度均匀性、均匀晶体结构、磁性、表面积和结构、吸附性能、生物相容性、硬度性和柔韧性、溶解性、低毒性和无过敏反应等。
因为磁性纳米粒子具有稳定性，它被广泛应用于药物注射。磁性纳米粒子能把药物(在最大负荷下)高效安全地转移到特定的位置。以下纳米磁性参数对于作为药物载体的应用至关重要，它们具有最小的粒径和更大的表面，从而增加了淀积时间，并且磁性纳米粒子的表面特性会保护其防止退化，使其成为具有良好生物相容性的药载体。它们具有优异的磁性，能够降低血液中纳米磁的浓度，并及时将药物带到靶侧。
使用磁性纳米颗粒的一些问题包括它们的体内系统行为。在转移到靶组织之前，体内使用的有效性取决于磁性纳米粒子穿过血管内皮或血脑屏障等生物屏障的能力以及网状内皮系统的识别和纯化能力。间接地说，磁性纳米粒子的有效性高度依赖于它们的尺寸、形态、电荷化学和表面特性。为了增加磁性纳米粒子的有效性，人们采用了几种方法，如减小粒径和去除聚合物的进入。
药物运载的新一代纳米颗粒包括新的纳米晶核、涂层材料和提高纳米颗粒检测和纳米颗粒特异运载的功能性配位体。磁性纳米粒子的新核心成分，如合金的氧化铁纳米晶、金属/合金的纳米颗粒和纳米复合材料，这些核心提供了高磁矩，提高了它们在磁共振成像下的信号背景比。同时，新表面涂层，如稳定的金或硅壳结构的使用，使得可以使用其他有毒基底材料，以及通过在纳米粒子表面形成自组织单分子膜(SAMS)来更彻底地包覆粒子。
以Fe3O4为壳层(HMS@PEG-PLA)的空心Fe3O4/SiO2微球的制备方法已被知晓。这种三重纳米复合材料的优点在于其中空结构，纳米复合材料可装载大量药物；由于其磁性，可通过外加磁场轻松操纵，还由于聚合物聚-(乙二醇)-聚-(D，L-丙交酯)具有可生物降解和生物活性的外壳，它具有生物相容性。[8]
此外，最近的研究和综述表明，细胞力学在疟疾和癌症转移等疾病中的作用越来越大。因此，下一代平台具有巨大的潜力，包括能够探测和/或控制长度范围内局部物理和机械变化的表面特性，这将大大有助于改进疾病检测、监测、诊断和治疗。
纳米磁体在热疗中的应用：用于热疗磁直接治疗的颗粒包括直径为几毫米(1-300毫米)的棒和1-100纳米的纳米颗粒等粒子。在进行临床试验时，一种热疗方法值得关注，包括对靶向肿瘤细胞的间质加热，然后直接将磁性纳米颗粒引入目标部位。对于前列腺癌的纳米磁治疗，这项临床试验成分两个阶段进行。第一阶段是应用磁性纳米粒子热疗，第二阶段是持续近距离放射治疗时应用纳米粒子磁治疗。这种新方法需要基于适当的可视化和建模方法的规划、质量控制和热监测的特定工具。近年来，多相磁性复合材料已成功地应用于热疗的可调磁系统，以改变其自身的磁性能，其中各种磁性相的纯贡献使得改变复合材料的磁化强度和各向异性成为可能。例如，这种方法要求使用已经获得的混合相复合材料SrFe12O19/MgFe2O4/ZrO2，以及具备有效的热处理能力。硬/软复合材料的磁性能SrFe12O19/NiFe2O4/ZnFe2O4,SrFe12O19/ZnFe2O4和SrFe12O19/γ-Fe2O3已经被研究。
结果表现，软、硬相间的交换作用对复合材料的磁化强度和矫顽力有很大的影响。
将纳米粒子作为涂层放置在膏药、敷料上众所周知的经皮给药方法与上述方法相似[9]。该文献资料公开了使用纳米颗粒通过载体表皮递送药物制剂的方法。
但是，目前金属氧化物纳米颗粒(尤其是磁铁矿(Fe3O4)和/或磁赤铁矿(γ-Fe2O3)涂层的使用还未公开，该涂层是保障吸附金属颗粒和毒素的膏药的成分。
发明内容
本发明的目的是研发一种新型经皮膏药，这种膏药可以保障在使用膏药位置对人体内重金属和毒素颗粒进行吸附。
该技术成果在于通过在粘合剂基体上施加一层基于氧化铁磁铁矿(Fe3O4)和/或磁铁矿(γ-Fe2O3)的磁性纳米粒子来吸附和去除人体中的重金属颗粒。
此外，本发明的应用效果是通过降低人体内有害元素的浓度而对人体健康的总体改善。
该透皮贴剂包括由织物材料制成的基底，基底上有粘合层，粘合层上有磁基底，磁基底上有磁性氧化铁Fe3O4和/或γ-Fe2O3磁性纳米粒子层，以及至于纳米粒子层上方的由可撕脱材料保护层所保护的固定渗透层。
在一个具体实施案例中，通过冷喷涂方式施加纳米粒子层。
在另一具体实施案例中，先经过超声处理，后进行喷涂。
在另一具体实施案例中，在粘合剂基底表面上纳米粒子层以20-60克/平方米的比率均匀地喷涂。
在另一具体实施案例中，Fe3O4纳米粒子的大小为10至100纳米±20％。
在另一具体实施案例中，γ-Fe2O3纳米粒子的尺寸不超过20纳米。
在另一具体实施案例中，纺织材料是机织或非机织材料的。
在另一具体实施案例中，磁性基板是磁性箔或磁性纸或磁性乙烯基。
在另一具体实施例案中，固定层固定在磁性基板上。
在另一具体实施案例中，可透皮固定层是可透皮或半透皮超细纤维。
说明书附图
图1为上述膏药概貌。
具体实施方式
图1为贴片10的视图。该贴片包含基片1，该基片以纺织材料织物基材的形式制成。纺织材料可以是不同类型的机织或无纺布材料。粘合剂层，例如，热熔粘合剂位于2织物基底1上。
在粘合层2上为磁性基底，磁性基底是磁性薄膜、磁性乙烯基(弹性橡胶状材料)或磁性纸的形式，其上具有一层氧化铁磁性纳米粒子4，尤其是磁铁矿Fe3O4和/或磁铁矿γ-Fe2O3。在有纳米粒子层4的磁性基底3上是可撕脱材料6，如纸。
另外，在具有纳米粒子层4的磁性基板3上，可在上部安装可透皮或半透性纳米颗粒材料固定层5，例如超细纤维。固定层5的使用旨在减少或消除使用贴片10时过敏反应，以及消除皮肤对贴片10使用位置处纳米颗粒稳定性的影响。
纳米粒子层4可通过冷喷涂等方式施加，而纳米粒子先可通过超声波处理程序预分离。纳米粒子层4以20～60克/平方米的比例均匀地喷涂到磁性基底的表面上。纳米粒子的制造尺寸如下：Fe3O4—10纳米至100纳米±20％；γ-Fe2O3—不超过20纳米。
下表1为根据所要求技术方案获得的产品示例。
表1.产品示例
实验得出了纳米粒子尺寸与贴片工作表面沉积层厚度的最佳比例，该比例表明在指定的边界范围内可以观察到稳定的正效应。当使用其他参数时，效果没有改变或变差，因此给出了达到规定技术结果所需的最优值。
纳米粒子尺寸是根据该技术领域的现有科学研究数据([10]-[11])，并根据本次申请公开的内容在产品制造方面进行经验性的实验而选择的。
所有重金属中毒症状大致相同。急性中毒的第一反应是消化道症状(蠕动障碍、疼痛、恶心、呕吐)。重金属被吸收到血液时，会发生心脏，血管(压力骤增、呼吸急促)、肾脏和肝脏反应。当重金属影响神经系统，就会对身体产生不可逆转的后果，就像水俣病一样。
为了研究纳米颗粒在本贴片10中的作用，研究人员对50位小组成员进行了研究。对针灸医疗中心病人和冶金业员工进行了研究。研究表现，使用带有磁性纳米颗粒的贴片10时，人体内最初可用的重金属生化指标会降低。降低原因是纳米磁性颗粒通过贴片10吸附了一定量的重金属。
这种吸附作用有助减少它们在人体内的数量。通过贴片10吸附而减少重金属数量，提高重金属中毒保守治疗的有效性，从而获得更快的治疗效果。此外，这种吸附作用有助于降低人体中的重金属含量，以达到预防目的，即从人体中清除生产和日常生活中的重金属。在所有的病例中，对照生化分析显示，使用膏药后人体内重金属含量都有所下降。
在研究过程中，发现在贴片10上沉积纳米粒子层2与人汗腺的相互作用过程中，重金属颗粒持续吸附并随后从体内排出。
参与群体中以下变化比较典型：
1号参与者
病人被送往其中一家医院的感染病房，疑似中毒并伴有中毒症状(恶心、呕吐、胃痛)。对重金属的选择性分析表明体内羰基镍超标。使用贴片10，在胃肠道放置约8小时后，反复分析结果显示体内羰基镍明显减少。本次使用了35克纳米颗粒/平方米的膏药。
2号参与者
病人肘关节和肩关节持续疼痛。分析结果表明，体内羰基镍颗粒含量超标。将贴片10贴在疼痛部位5天后，可以观察其体内的羰基镍有所减少，病人疼痛有所缓解。
1号和2号参与者是冶金厂的员工。
3号参与者
病人听力下降。诊断表明听觉神经有故障。分析表明，人体内汞粒子的数量超标。反复研究表明，在耳背处使用膏药后体内汞粒子减少。结合医学生理程序和保守治疗，可观察到其听力在积极恢复。
4号参与者
病人肩部皮肤隐性病变。分析表明，肩部皮肤被汞蒸汽损害。传统治疗并没有好结果，因为汞蒸气是在表皮层。在皮肤受影响区域使用纳米颗粒浓度更高的(35克/平方米)的贴片，可以去除表皮深层的汞颗粒，再加上保守治疗，效果显著。
5号参与者
病人长期吸烟，咳嗽，呼吸困难。分析表明，体内有大量的重金属盐，如砷、镍、镉和铍。在肺部和背部使用贴片10，持续7天，每天8个小时，改善了患者的病情，体内这些重金属含量减少。肺痰瘀阻消除，整体健康状况得到改善，慢性咳嗽也减少了。
在所有引用的例子中，重金属颗粒吸附以及随后从体内排出都是通过病人的汗腺进行的。一般来说，当一个人进行测量活动时，平均吸附时间约为8个小时。随着运动强度的增加，例如跑步、快走、健身等，由于刺激汗腺以及相应的出汗，身体清洁过程会加快。
参考文献
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Claims (9)
1.一种透皮贴剂，其特征在于，包含由纺织材料制成的基底，所述基底上设有粘合层，所述粘合层上设有磁性基底，所述磁性基底上设有氧化铁Fe3O4和/或γ-Fe2O3磁性纳米粒子层，可撕脱材料保护层设置在固定渗透层上方，所述纳米粒子层以20-60克/平方米的比例均匀地喷涂在所述基底表面。
2.根据权利要求1所述的贴剂，其特征在于，所述纳米粒子层通过冷喷涂施加。
3.根据权利要求2所述的贴剂，其特征在于，喷涂前先经过超声波处理。
4.根据权利要求1所述的贴剂，其特征在于，Fe3O4纳米粒子尺寸为10-100纳米±20％。
5.根据权利要求1所述的贴剂，其特征在于，γ-Fe2O3纳米粒子尺寸不超过20纳米。
6.根据权利要求1所述的贴剂，其特征在于，所述纺织材料为机织或非织造材料。
7.根据权利要求1所述的贴剂，其特征在于，所述磁性基底为磁性箔或磁性纸或磁性乙烯基。
8.根据权利要求1所述的贴剂，其特征在于，还包含附着在所述磁性基底上的固定层。
9.根据权利要求8所述的贴剂，其特征在于，所述固定渗透层是可渗透或半渗透的超细纤维。
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Citations (7)
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| CN1432363A (zh) * | 2002-12-24 | 2003-07-30 | 复旦大学 | 川芎嗪透皮贴剂及其制备方法 |
| CN2717437Y (zh) * | 2003-12-18 | 2005-08-17 | 史长明 | 一种经皮给药的纳米光谱药物贴剂 |
| US20110105825A1 (en) * | 2009-10-31 | 2011-05-05 | Qteris Inc. | Nanoparticle-sized magnetic absorption enhancers having three-dimensional geometries adapted for improved diagnostics and hyperthermic treatment |
| CN106551755A (zh) * | 2016-11-30 | 2017-04-05 | 兰州交通大学 | 一种磁纳米药物贴及其制备方法 |
| CN108697655A (zh) * | 2015-12-30 | 2018-10-23 | 考里安国际公司 | 用于长期透皮施药的系统和方法 |
| RU189268U1 (ru) * | 2019-03-22 | 2019-05-17 | Артем Олегович Бахметьев | Акупунктурная игла |
| RU189308U1 (ru) * | 2019-03-22 | 2019-05-21 | Артем Олегович Бахметьев | Трансдермальный пластырь |
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| RU2031648C1 (ru) * | 1992-01-21 | 1995-03-27 | Людмила Алексеевна Попова | Пластырь |
| DE4405898A1 (de) * | 1994-02-18 | 1995-08-24 | Schering Ag | Transdermale therapeutische Systeme enthaltend Sexualsteroide |
| WO2009070282A1 (en) * | 2007-11-26 | 2009-06-04 | Stc.Unm | Active nanoparticles and method of using |
| DE102011114411A1 (de) * | 2011-09-26 | 2013-03-28 | Lts Lohmann Therapie-Systeme Ag | Pflaster mit einstellbarer Okklusion |
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Patent Citations (7)
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|---|---|---|---|---|
| CN1432363A (zh) * | 2002-12-24 | 2003-07-30 | 复旦大学 | 川芎嗪透皮贴剂及其制备方法 |
| CN2717437Y (zh) * | 2003-12-18 | 2005-08-17 | 史长明 | 一种经皮给药的纳米光谱药物贴剂 |
| US20110105825A1 (en) * | 2009-10-31 | 2011-05-05 | Qteris Inc. | Nanoparticle-sized magnetic absorption enhancers having three-dimensional geometries adapted for improved diagnostics and hyperthermic treatment |
| CN108697655A (zh) * | 2015-12-30 | 2018-10-23 | 考里安国际公司 | 用于长期透皮施药的系统和方法 |
| CN106551755A (zh) * | 2016-11-30 | 2017-04-05 | 兰州交通大学 | 一种磁纳米药物贴及其制备方法 |
| RU189268U1 (ru) * | 2019-03-22 | 2019-05-17 | Артем Олегович Бахметьев | Акупунктурная игла |
| RU189308U1 (ru) * | 2019-03-22 | 2019-05-21 | Артем Олегович Бахметьев | Трансдермальный пластырь |
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| CN114072113B (zh) | 2023-03-24 |
| RU2705896C1 (ru) | 2019-11-12 |
| WO2021020990A1 (ru) | 2021-02-04 |
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