CN110652658A - 使用光和葡糖胺盐酸盐处理皮肤病症的组合物和方法 - Google Patents
使用光和葡糖胺盐酸盐处理皮肤病症的组合物和方法 Download PDFInfo
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Abstract
本公开题为“使用光和葡糖胺盐酸盐处理皮肤病症的组合物和方法”。本发明提供用于处理皮肤的组合物、方法和试剂盒，该组合物、方法和试剂盒组合施用葡糖胺盐酸盐以及峰值波长为约600nm至约750nm的红光和/或峰值波长为约750nm至约1000nm的近红外光。
Description
技术领域
透明质酸存在于所有结缔组织中。在皮肤中，透明质酸由成纤维细胞和角质细胞产生。透明质酸可结合其重量1000倍的水，并且可帮助皮肤保留且保持水。在年轻的皮肤中，透明质酸位于胶原蛋白和弹性蛋白纤维的周边以及这些纤维相交的地方。与年轻的皮肤相比，老化的皮肤不那么饱满，其特征在于透明质酸水平降低。这样降低的透明质酸水平促使其与胶原蛋白和弹性蛋白分离以及减少与水的结合。因此，透明质酸水平的降低涉及皮肤老化迹象，包括皱纹、弹性改变、张力减少以及支持皮肤微血管系统的能力减弱。皮肤老化的主要临床迹象是细纹和皱纹的出现，其随着年龄的增加而增多。
已提出用于抵抗皱纹和细纹的不同产品和方法，并且透明质酸本身均被商业用作可注射美容产品和局部美容产品中的活性剂以增强皮肤的保湿和弹性。然而，透明质酸在皮肤上和注射到皮肤中时具有有限的寿命。透明质酸酶(存在于皮肤中的酶)会分解透明质酸，从而降低其作用。透明质酸的半衰期对于不同组织是变化的，但在真皮和表皮上为约一天。此外，已经证实由于外源透明质酸的大小而难以通过局部施用将其渗透到皮肤中。
市场上有售口服补充剂形式的葡糖胺以支持人类和动物关节的结构和功能。葡糖胺的常用销售形式为葡糖胺硫酸盐、葡糖胺盐酸盐和N-乙酰基葡糖胺。
葡糖胺在一些口服补充剂中用来治疗关节疼痛，但未广泛用于皮肤护理。
光疗法也已知对治疗皮肤病症有效，并且已知波长为约633nm的红光具有抗炎效果。红光抗炎作用的机制被认为是通过抑制炎性介质和酶(诸如白介素-1a和基质金属蛋白酶)而发生的。
US 8,771,328公开了改善的光疗系统，包括可为面膜形式的设置在便利装置中的用于辐射灯(诸如LED辐射灯)的治疗灯平台。该系统发出不同波长的辐射能，例如蓝、红或红外中的至少两种。
露得清光疗痤疮面膜(NEUTROGENA Light Therapy Acne Mask，可从Johnson&Johnson Consumer Inc.商购获得)发出蓝光以穿透皮肤表面正下方，从而杀死痤疮导致的细菌，并且发出深入穿透皮肤的红光以减轻炎症。
US 7,066,941涉及老化或受损皮肤通过利用有效量的波长为约400nm至约500nm的可见光对其进行辐照而进行的治疗。光源可为日光或人造光，例如在一个实施方案中，将发光二极管应用于离散的皮肤区域。可在光治疗之前或期间，将包含使角质层的光穿透增强的化合物(诸如α-羟基酸)的组合物和/或滤清器灯应用于皮肤。
WO 2016/146778涉及提供皮肤护理的美容方法，该方法包括用一个或多个光束照射个体的皮肤，该光束向皮肤提供具有与绿光、红光和近红外光相对应的波长的峰的不连续光谱的光，以及涉及可包含多种成分(包括葡糖胺)的局部用组合物。据称此类方法有利于涉及皮肤细胞增殖和迁移以及细胞外基质纤维(诸如胶原蛋白)的产生的皮肤活化过程。
申请人现已发现，通过施用包含至多约2重量％的葡糖胺盐酸盐的局部用组合物以及使用光递送装置将所述皮肤暴露于红光和近红外光，可令人惊奇地上调皮肤产生的透明质酸，从而为皮肤提供显著且出乎意料的有益效果，包括改善、减少、抑制或延缓出现皮肤老化的至少一种迹象。该组合还可增强皮肤屏障保护和皮肤保湿。因此，现在可得到例如处理皮肤老化迹象和保湿皮肤的新方法。
发明内容
本发明提供一种增加皮肤产生的透明质酸的方法，该方法包括向此类皮肤局部施用包含至多约2重量％的葡糖胺盐酸盐的局部用组合物，以及使用光递送装置将所述皮肤暴露于峰值波长为约600nm至约750nm的红光和/或峰值波长为约750nm至约1000nm的近红外光。
本发明还提供一种处理皮肤的方法，该方法包括向需要处理皮肤老化迹象的皮肤局部施用包含至多约2重量％的葡糖胺盐酸盐的局部用组合物，以及使用光递送装置将所述皮肤暴露于峰值波长为约600nm至约750nm的红光和/或峰值波长为约750nm至约1000nm的近红外光。
本发明还提供一种处理皮肤的方法，该方法包括向需要保湿的皮肤局部施用包含至多约2重量％的葡糖胺盐酸盐的局部用组合物，以及使用光递送装置将所述皮肤暴露于峰值波长为约600nm至约750nm的红光和/或峰值波长为约750nm至约1000nm的近红外光。
本发明还提供一种试剂盒，该试剂盒包括：(a)包含至多约2重量％的葡糖胺盐酸盐的局部用组合物，以及(b)递送峰值波长为约600nm至约750nm的红光和/或峰值波长为约750nm至约1000nm的近红外光的光递送装置。
本发明还提供一种包含约0.1重量％至约2重量％的葡糖胺盐酸盐和至少一种pKa为约2.5至约4.5的化合物的局部用组合物，所述组合物具有小于约5.5的pH。
本发明还提供一种包含局部用组合物的膜，该局部用组合物包含约0.1重量％至约2重量％的葡糖胺盐酸盐和至少一种pKa为约2.5至约4.5的化合物，所述组合物具有小于约5.5的pH。
具体实施方式
除非另有定义，否则本文使用的所有技术和科学术语具有本发明所属领域的普通技术人员通常所理解的相同含义。将本文提及的所有出版物、专利申请、专利以及其它参考文献通过引用方式并入本文。
如本文所用，“局部施用”意指例如用手或涂覆器(例如擦拭物、滚筒或喷雾器)直接敷在或抹在外层皮肤或头皮上。
如本文所用，“美容品”是指能保留、恢复、给予、刺激或增强体美外观或似乎能增进美貌或年轻的美化物质或制品，尤其是涉及组织或皮肤的外观时。
如本文所用，“美容上有效量”意指足以处理一种或多种病症、但充分低以避免严重副作用的生理活性化合物或组合物的量。化合物或组合物的美容上有效量将会随以下因素而变：所治疗的具体病症、最终用户的年龄和身体状况、所治疗/预防的病症的严重程度、治疗的持续时间、其它治疗的性质、所采用的具体化合物或产品/组合物、所具体采用的美容上可接受的载体等等。
如本文所用，“美容上可接受的”意指该术语描述的成分适于与组织(例如，皮肤)接触使用而不会引起不适当的毒性、不相容性、不稳定性、剌激性、变应性应答等。
如本文所用，“美容上可接受的活性剂”是对皮肤具有美容或治疗效果的化合物(合成的或天然的)。
如本文所用，“处理或治疗”是指减轻、减少、预防、改善或消除病症或障碍的存在或病征。
本发明适用于处理皮肤老化迹象。如本文所用，“皮肤老化迹象”包括存在细纹和皱纹、弹性损失、肤色不均和斑疤。在特别优选的实施方案中，老化迹象是存在细纹和皱纹和/或弹性损失。
如本文所用，“皱纹”包括微细纹、微皱纹或粗皱纹。皱纹的示例包括但不限于眼部周围的微细纹(例如“鱼尾纹”)、前额和颊皱纹、眉心纹和嘴部周围的笑纹。
如本文所用，“弹性损失”包括皮肤或组织的弹性或结构完整性的损失，包括但不限于松垂、松弛和松散的组织。弹性或组织结构完整性的损失可由多种因素所致，包括但不限于疾病、衰老、激素变化、机械创伤、环境损害，或者是向组织施用产品诸如美容品或药物的结果。
如本文所用，“肤色不均”意指与弥漫状或斑驳状色素沉着有关的皮肤状况，该色素沉着可分类为色素沉着过度，诸如发炎后色素沉着过度。
如本文所用，“斑疤”意指与发红或红斑相关的皮肤状况。
本发明的组合物也可用于处理需要保湿的皮肤。如本文所用，“需要保湿的皮肤”意指但不限于缺乏水分、缺乏皮脂、破裂、干燥、发痒、鳞屑、干皮、脱水、缺乏柔韧性、缺乏光彩、无光泽或缺乏脂质的皮肤。
除非另外指明，否则百分比或浓度是指重量百分比或重量浓度(即％(重量/重量))。除非另外阐明，否则所有范围均包括端值，例如，“4至9”包括端值4和9。
包含葡糖胺盐酸盐的局部用组合物
本发明利用包含葡糖胺盐酸盐的局部用组合物。
该局部用组合物可包含至多约2重量％、优选至多约1.5重量％或更优选至多约1重量％的葡糖胺盐酸盐。
葡糖胺可以各种形式提供，包括多种盐和衍生物。本发明人发现，当与红外光和/或红光组合时，并非所有葡糖胺形式都提供优异的效果。令人惊讶的是，施用葡糖胺盐酸盐与红外光和/或红光组合协同增加透明质酸的产生。在葡糖胺磷酸酯、N-乙酰基葡糖胺或葡糖胺中未观察到这种情况。
葡糖胺盐酸盐可从例如Sigma Aldrich商购获得。
组合物可任选地包含各种各样的另外的油溶性物质和/或水溶性物质，这些物质通常用于组合物中，按本领域既定的水平施用于皮肤。例如，可包括表面活性剂、珠光剂或遮光剂、增稠剂、润肤剂、调理剂、湿润剂、螯合剂、剥脱剂和添加剂，所述添加剂增强组合物的外观、感觉或香味，诸如着色剂、芳香剂、防腐剂、pH调节剂等。
组合物可包含一种或多种其它美容上可接受的活性剂，包括例如其它抗老化剂和保湿剂、抗痤疮剂、光泽控制剂、抗微生物剂、抗炎剂、抗真菌剂、抗寄生虫剂、外用止痛剂、防晒剂、光防护剂、抗氧化剂、角质层分离剂、表面活性剂、营养物质、维生素、增能剂、抗汗剂、收敛剂、除臭剂、固化剂、抗硬剂、皮肤调理剂、以及亮肤剂。
其它美容活性剂的量可在按组合物的重量计约0.001％至约20％，例如，按组合物的重量计约0.005％至约10％，诸如按组合物的重量计约0.01％至约5％的范围内。
美容上可接受的活性剂可选自例如过氧化苯甲酰，D-泛醇类胡萝卜素，神经酰胺，多不饱和脂肪酸，必需脂肪酸，酶诸如漆酶，酶抑制剂，矿物质，激素诸如雌激素，类固醇如氢化可的松、2-二甲基氨乙醇，铜盐诸如氯化铜，多肽类如六胜肽、三胜肽、以及含铜的那些，辅酶Q10，氨基酸诸如脯氨酸，维生素，乳糖醛酸，乙酰辅酶A，烟酸，核黄素，硫胺，核糖，电子转运蛋白诸如NADH和FADH2，天然提取物诸如来自芦荟、野甘菊、燕麦片、莳萝、黑莓、毛泡桐、毕赤酵母，以及菊苣、间苯二酚诸如4-己基间苯二酚、姜黄素类化合物，糖胺诸如N-乙酰基葡糖胺和除葡糖胺盐酸盐之外的其它葡糖胺，以及它们的衍生物和混合物。
维生素的示例包括但不限于维生素A、维生素B类(诸如，维生素B3、维生素B5和维生素B12)、维生素C、维生素K和不同形式的维生素E(像α、β、γ和Δ生育酚或它们的混合物)以及它们的衍生物。
抗氧化剂的示例包括但不限于水溶性抗氧化剂，诸如巯基化合物及其衍生物(例如，焦亚硫酸钠和N-乙酰基-半胱氨酸)、硫辛酸和二氢硫辛酸、白藜芦醇、乳铁蛋白以及抗坏血酸和抗坏血酸衍生物(例如，抗坏血酸棕榈酸酯和抗坏血酸多肽)。适用于本发明的组合物中的油溶性抗氧化剂包括但不限于丁基化羟基甲苯、类视色素(例如，视黄醇和棕榈酸视黄酯)、生育酚类(例如，生育酚乙酯)、生育三烯酚类和泛醌。含有适用于本发明的组合物中的抗氧化剂的天然提取物包括但不限于：含有类黄酮和异黄酮类以及它们的衍生物(例如染料木黄酮和木质素异黄酮)的提取物、含有白藜芦醇的提取物等等。此类天然提取物的示例包括葡萄籽、绿茶、松树皮和蜂胶。
在一个实施方案中，局部用组合物包含至少约4重量％、或约4重量％至约20重量％的甘油，例如约6重量％至约10重量％的甘油。
在另一个实施方案中，局部用组合物包含约0.1重量％至约2重量％的葡糖胺盐酸盐和至少一种pKa为约2.5至约4.5的化合物，所述组合物具有小于约5.5的pH。例如，pKa为约2.5至约4.5的化合物可选自柠檬酸、乳酸、乙醇酸、琥珀酸以及它们的混合物。
在另一个实施方案中，局部用组合物还包含亚硫酸氢钠。
组合物还可包含美容上可接受的局部用载体。该载体可占组合物的约50重量％至约99.99重量％(例如占组合物的约80重量％至约99重量％)。在本发明的一个实施方案中，美容上可接受的局部用载体包括水。
可将组合物制备成多种产品类型，包括但不限于洗剂、霜剂、凝胶剂、棒剂、喷雾剂、油膏剂、糊剂、泡沫剂、粉末剂、摩丝、霜膏、擦拭物、贴剂、水凝胶、成膜产品、面膜和皮肤膜剂、溶解或非溶解膜剂，以及化妆品如粉底。这些产品类型可含有多种美容上可接受的局部用载体，包括但不限于溶液、悬浮液、乳液(诸如微乳液和纳米乳液)、凝胶、固体、膜和脂质体。下面是此类载体的非限制性示例。其它载体可由本领域的普通技术人员进行配制。
可将组合物配制为溶液。溶液通常包含水性溶剂或有机溶剂(例如，约50％至约99.99％或约90％至约99％的美容上可接受的水性溶剂或有机溶剂)。合适的有机溶剂的示例包括：丙二醇、聚乙二醇、聚丙二醇、甘油、1,2,4-丁三醇、山梨醇酯、1,2,6-己三醇、乙醇以及它们的混合物。
可将组合物配制为包含润肤剂的溶液。此类组合物优选地含有约2％至约50％的一种或多种润肤剂。如本文所用，“润肤剂”是指用于诸如通过预防水经表皮从皮肤流失来预防或缓解干燥的物质。润肤剂的示例包括但不限于在Pepe、Wenninger和McEwen编著的《国际化妆品成分字典及手册》(International Cosmetic Ingredient Dictionary andHandbook)第2930-2936页(美国化妆品及香料协会，Washington,D.C.，第9版，2002)(在下文中，“ICI手册”)中所述的那些。特别合适的润肤剂的示例包括植物油、矿物油、脂肪酸酯等。
可由此类溶液制备洗剂。洗剂通常含有约1％至约20％(例如，约5％至约10％)的一种或多种润肤剂和约50％至约90％(例如，约60％至约80％)的水。
可由溶液配制的另一类产品是霜膏。霜膏通常含有约5％至约50％(例如，约10％至约20％)的一种或多种润肤剂和约45％至约85％(例如，约50％至约75％)的水。
组合物另选地为无水的或为不包含水而是包含有机溶剂和/或有机硅溶剂、油、脂质和蜡的膏剂。膏剂可含有简单的动物油或植物油或半固体烃类的底料。膏剂可含有约2％至约10％的一种或多种润肤剂和约0.1％至约2％的一种或多种增稠剂。增稠剂的示例包括但不限于ICI手册第2979-2984页中所述的那些。
组合物可被配制为乳液。如果局部用载体是乳液，则约1％至约10％(例如约2％至约5％)的该局部用载体含有一种或多种乳化剂。乳化剂可为非离子、阴离子或阳离子的。乳化剂的示例包括但不限于ICI手册第2962-2971页中所述的那些。
洗剂和霜膏可被配制为乳液。通常，此类洗剂包含0.5％至约5％的一种或多种乳化剂。此类霜剂通常包含约1％至约20％(例如，约5％至约10％)的润肤剂；约20％至约80％(例如30％至约70％)的水；以及约1％至约10％(例如，约2％至约5％)的乳化剂。
水包油型和油包水型的单乳液皮肤护理制剂诸如洗剂和霜膏是化妆品领域熟知的并且可用于本主题发明。多相乳液组合物，诸如水包油包水型或油包水包油型，也可用于本主题发明。通常，此类单乳液或多相乳液包含水、润肤剂和乳化剂作为主要成分。
所述组合物也可配制为凝胶(例如，使用合适的胶凝剂的水性凝胶、醇类凝胶、醇/水凝胶或油性凝胶)。用于水性凝胶和/或醇凝胶的合适胶凝剂包括但不限于天然树胶、丙烯酸和丙烯酸酯聚合物和共聚物以及纤维素衍生物(例如羟甲基纤维素和羟丙基纤维素)。适用于油(诸如矿物油)的胶凝剂包括但不限于氢化丁烯/乙烯/苯乙烯共聚物和氢化乙烯/丙烯/苯乙烯共聚物。此类凝胶通常包含约0.1重量％至5重量％的此类胶凝剂。
可将组合物配制成固体(例如，蜡基棒、条、或粉末)。
组合物可包含于基底，诸如膜、织造或非织造材料、擦拭物、贴剂、掩模、衣物制品等中。
在一个实施方案中，组合物包含于膜中。如本文所用，术语“膜”意指在哺乳动物，并且更具体地在人类皮肤上形成薄层或膜的组合物。此类膜可包括单层或多层。
在一个实施方案中，膜是可溶解膜。多种可溶解膜在本领域中是已知的，并且这些可溶解膜中的任一种均可根据本发明使用。
在一个具体实施方案中，膜可包括一体膜产品，如在US 2015/0182991中有所描述，其公开内容以引用方式并入本文。一体膜产品被布置和配置成能够从一体膜产品制备于其上的制造基底的移除，以便独立于制造基底使用。具体地，产品可如下制备：将掩模置于具有可剥离表面的制造基底之上，通过掩模递送成膜组合物，以在制造基底上形成原始形状；移除掩模；以及使原始形状固化成设置于制造基底上的一体膜产品。掩模具有至少一个孔，所述至少一个孔具有对应于所需一体膜产品的形状。一体膜产品被布置并配置成可从制造基底的可剥离表面移除，以便独立于制造基底使用。
在另一个实施方案中，膜可包括多层成型膜产品，如在US2015/0182990中有所描述，其公开内容以引用方式并入本文。例如，可使用两层成型膜产品，该两层成型膜产品包括包含待递送于皮肤的局部用组合物的第一表面，以及暴露于外部的第二表面。此类制品可使用包括如下的过程制备：通过掩模递送液体成膜组合物；移除掩模，留下多层原始形状；以及使多层原始形状固化，以形成多层成型膜产品。所述掩模具有递送表面、相背对的表面以及至少一个孔，所述至少一个孔具有对应于所需成型膜产品的设计。经多流路喷嘴来递送所述成膜组合物。控制所述掩模的移动以及所述第一液体成膜组合物和所述第二液体成膜组合物至所述掩模孔的递送，以将对应于空隙体积的一定体积流量的所述第一液体成膜组合物和所述第二液体成膜组合物提供至所述掩模孔。所述喷嘴与所述掩模的递送表面接触。
在另一个具体实施方案中，膜可为多层膜产品，如在US 2015/0182992中所述，其公开内容以引用方式并入本文。例如，可使用两层成型膜产品，其中第一层具有比设置于第一层上的第二层更大的表面积。这在第一层的顶部上形成第二层的“岛状物”。两层中的一层用于接触皮肤，并且包含本发明的组合物。另一层暴露于外部。此类制品可通过包括如下的过程制备：通过第一掩模递送第一成膜组合物，以形成第一原始形状；移除第一掩模；将第二掩模置于第一原始形状之上；通过第二掩模递送第二成膜组合物，以在第一原始形状上形成第二原始形状；移除第二掩模；以及使第一和第二原始形状固化，以提供成型膜产品。
在另一个实施方案中，成型膜产品(如US 2015/0182993中所述，其公开内容以引用方式并入本文)可包含组合物。此类成型膜产品可如下制备：将掩模置于制造基底之上；通过喷嘴递送成膜组合物，以在制造基底上形成原始形状；移除掩模；以及使成膜组合物固化，以提供设置在制造基底上的成型膜产品。掩模具有递送表面和相背对的面向制造基底的表面以及至少一个孔，所述至少一个孔具有对应于所需成型膜产品的设计。喷嘴被设置成在成膜组合物的递送期间与掩模的递送表面密封接合，并通至掩模的至少一个孔。
在另一个实施方案中，可使用多层局部施用膜，如在US 2016/0367490中所述，其公开内容以引用方式并入本文。该膜在将水施用到其上时能够容易地移除。如本文所用，“能够容易地移除”意指膜可在将水施用到膜上时溶解或崩解，使得其可从皮肤上移除而无需洗擦等。
此类膜包括第一顶层，该第一顶层具有从皮肤面向外的第一顶表面和面朝皮肤的与第一顶表面相对的第一底表面。制品还包括底部皮肤接触层，该底部皮肤接触层包括面向并粘附到第一顶层的第一底表面的第二顶表面和用于在将制品施用到皮肤上时使制品与皮肤接触并将制品粘附到皮肤上的面向外的第二底表面。底部皮肤接触层包含局部用组合物。此外，第一顶层和第二底层各自包含水溶性成膜剂，并且制品在将水施用到其上时能够容易地从皮肤移除。
该种包含局部用组合物的膜可通过上述形成多层成型膜产品的过程之一形成。其也可通过浇注和干燥粘结剂层，然后在底层的顶部上浇注顶层进行制备。两个层可通过已知的粘附方法(机械的、化学的、分散的、静电的、扩散的等)中的任一种彼此粘附。在一个实施方案中，两个层优选地都是水溶性的，使得非粘合的面向外的层中的水将稍微溶解已经干燥的粘合皮肤接触层，从而在两个层的界面处产生一定量的扩散粘附。在第二实施方案中，湿碰湿地浇注两个层，并且在其界面处发生材料的相互混合，从而通过扩散粘附产生粘结。优选地，材料具有共同的溶剂和/或彼此可混溶，使得它们相互混合并且粘结在一起。应当理解，粘合层和非粘合层(分别为皮肤接触层和面向外的层)的材料可具有除水之外的共同溶剂，诸如醇，使得材料彼此粘结。
例如，皮肤接触层优选地包含亲水性成膜聚合物、使膜中的其它成分溶解的增溶剂、崩解促进剂、增稠剂/结构化剂/质地改性剂，保持皮肤水分的吸湿剂/润湿剂、驱使吸湿剂进入皮肤中的分配系数改性剂/吸收或渗透促进物质、用于柔性和柔软度的增塑剂/主要粘合剂、用于水胶体并且用于保持潜在水分并保有最终制品柔性的溶剂以及其它助剂或添加剂。皮肤接触层优选直接施用到皮肤表面上，并且具有适于用作制品的皮肤接触表面的特性。此类特性包括快速溶解、持久的粘附强度、半吸留性和柔性。皮肤接触层包含葡糖胺盐酸盐和局部用组合物的其它成分。
面向外的层具有适于用作物理屏障的特性，当制品保持在施用部位上的适当位置时，允许其保持无粉尘和污物以及碎屑。此类特性包括快速溶解、半吸留性、柔性和非粘着性。面向外的层包含亲水性成膜聚合物、崩解促进剂、水包油乳化剂、限制水从皮肤接触层向局部层迁移的蜡、用于柔性和柔软度的增塑剂、主要的粘合剂、用于水胶体并且用于保持潜在水分并保有最终制品柔性的溶剂以及其它助剂或添加剂。
在本发明的具体实施方案中，局部用组合物包含在此类多层水可移除膜中。膜可具有例如至多约2mm的厚度。通过使第二底部表面粘附于皮肤而将膜置于皮肤上。然后，使用根据本发明的光递送装置，使膜暴露于峰值波长为400nm至460nm的蓝光。使膜保持就位一定的时段，例如，至少15分钟，或至少30分钟，或至少3小时，或至少6小时，由此葡糖胺盐酸盐能够转移至皮肤施用部位。然后通过施用水(此时膜溶解)从施用部位移除膜。
在上文的另一个实施方案中，底部皮肤接触层还包含有效量的乳化剂，以增强葡糖胺盐酸盐到皮肤的运送。在一个实施方案中，乳化剂是甘油衍生物。例如，乳化剂可选自甘油酯和甘油脂肪酸酯。
光递送装置
光递送装置可包括任何红光源和/或近红外光源。在一个实施方案中，光递送装置同时递送红光和近红外光。
如本文所用，“红”光是指具有约600nm至约750nm、优选约600nm至约700nm的峰值波长的光。在一个实施方案中，红光具有约633nm的峰值波长。
如本文所用，“近红外”光是指具有约750nm至约1000nm、优选约800nm至约900nm的峰值波长的光。在一个实施方案中，近红外光具有约830nm的峰值波长。
光递送装置可采取任何形式或构型，只要其发射红光和/或近红外光即可。光能够在期望范围内或者以所需波长连续、脉冲、聚焦、漫射、多波长、相干或不相干地递送。
在某些优选的实施方案中，仅将红光、仅将近红外光，或仅将红光和近红外光递送至皮肤。即，通过过滤其它波长或在由光递送装置递送的光中不存在此类波长，而不将此类其它波长的光递送至皮肤。
在另一个此类实施方案中，仅递送红光。
在另一个实施方案中，仅递送近红外光。
在一个特别优选的实施方案中，递送红光和近红外光两者。
光优选地以较低强度递送。在一个实施方案中，光的功率递送小于约20mW/cm2。例如，可以约1mW/cm2至约20mW/cm2的强度递送光。在另一个实施方案中，光的强度低于约1mW/cm2。
光源可例如为一个或多个LED。LED可例如为单个LED灯泡或多LED条。
装置可为用于面部的成型掩模、护罩、或头罩形式。另选地，装置可被成型为在身体上使用，特别是躯干，诸如衬衫、背心等。装置可为具有圆形、椭圆形、矩形或其它形状的形式或贴剂。此类贴剂也可具有不规则形状，或者被设计成配合面部或身体特定部分的形状。
在一个实施方案中，装置包括灯平台和远程电池组，如在US8,771,328中所述，其公开内容以引用方式并入本文。用于辐射灯(如LED)的灯平台被设置在包括第一壁和第二壁的组件中，所述第一壁附连所述辐射灯并且所述第二壁更靠近皮肤与所述第一壁间隔开，其中所述灯相对于所述第二壁为嵌入的。第二壁包括面向皮肤的反射表面，以及与第一壁上的LED基本上对齐的多个光照孔以用于将灯辐射从灯传送到用户。灯及其相关联的电路设置在第一壁和第二壁之间，使得反射表面为相对光滑的并且无缝地朝向皮肤。灯的数量被最少化，其电路情况也同样如此，并且其它组件材料被有目的地选用于相对较轻的组件，该较轻的组件在治疗疗程期间导致增强的用户舒适度。就相对于用户的柔性可调节性而言，壁具有可塑的刚度。更具体地，壁相对于用户的面部具有凹形构型，该凹形构型相对于静止位置为可调节的，相对于用户头部尺寸为能够膨胀的，以在使用期间用于紧密地配合和牢靠地接合用户。利用框架将装置安装到用户，该框架包括眼镜框架或包括用于屏蔽用户眼镜免受灯辐射的护目镜。实施方案的可调节性还被能够相对于支撑框架枢转的壁增强，并且其中框架可包括伸缩式镜臂以用于相对于用户的头部尺寸进行可选的调节。装置因此作为可穿戴式免手持的面罩等被支撑在患者身上。功率源将能量传送到灯，并且包括远程电池组并且还可包括控制处理器，该控制处理器用于通过装置对用户的使用数量进行计数，并且用于指示预定的使用数量之后替换装置的需要。
平台可通过多个构件被固定到头部，所述构件为：眼镜框架、条带、拉带、带具、VELCRO、拨盘或按扣以及按钮。当面罩被固定时，它可被向上调节以用于下巴到额头的覆盖。它还可被向外调节以用于左右覆盖。此外，一旦平台已经被弯曲/滑动成覆盖面部区域，则平台距皮肤的距离可被调节以用于实现相对于用户的皮肤表面的期望的光强度。因此，光照治疗可在至多三个物理维度中最大化。
主题可调节性可通过“智能”处理和用于增强的柔韧性/可调节性的感测系统以可调节式能量输出、可调节式波长、优先区域、定时器等的形式实现。传感器系统的传感器将允许主题实施方案具有利用颜色、痤疮、病灶密度等的传感器评估患者面部和身体皮肤的能力，并且利用优先区域上或多或少的能量定制智能处理的计划。从皮肤类型、年龄、问题的总体严重性的角度来看，主题实施方案可为智能的，并且因此具有定制处理的能力。
在另一个实施方案中，装置包括设置于手持点涂覆器组件中的用于辐射灯(诸如LED)的治疗灯平台，如在US 2016/0045758中所述，其公开内容以引用方式并入本文。手持点涂覆器组件包括面向患者的反射表面，以及多个LED辐射灯以用于将灯辐射从灯传送到用户。所述灯和关联电路容纳在可保持式细长结构内。
在一个实施方案中，还将超声能量与光同时或串行地递送至皮肤。超声能量可由灯设备或单独设备递送。
在一个实施方案中，光递送装置同时递送光照和超声能量。
透明质酸的产生
根据本发明，局部施用葡糖胺盐酸盐和将皮肤暴露于红光和/或近红外光的组合出乎意料地增加了由此类皮肤产生的透明质酸。已发现，相对于单独局部施用葡糖胺盐酸盐或暴露于红外光和/或近红外光产生的透明质酸的量，此类组合能够协同增加皮肤产生的透明质酸量。
此外，红光和/或近红外光暴露与其它活性成分(包括其它形式的葡糖胺)的组合并不能协同增加皮肤中的透明质酸产生。
在一个实施方案中，该组合增加透明质酸的产生量至少1.5倍。
透明质酸的产生量可通过以下方法测量。
将人真皮成纤维细胞维持在烧瓶中的生长培养基中，该生长培养基由杜尔贝科改良伊格尔培养基(DMEM)加上10％胎牛血清、50单位/ml青霉素和50μg/ml链霉素组成。在无酚红的杜尔贝科改良伊格尔培养基(DMEM)加上2％胎牛血清、50单位/ml青霉素和50μg/ml链霉素中，在96孔板的每个孔中接种10,000个细胞24小时，然后再进行处理。将葡糖胺盐酸盐或其它活性物质溶解于1x PBS的10％原液中，以不同浓度添加到培养基中，持续48小时。在处理后48小时收集培养基，并且使用透明质酸ELISA试剂盒(Echelon，目录号K-1200)遵循制造商方案测量HA(透明质酸)分泌。为了评估活性，在405nm处测量比色几率。
用来自每个单独处理物的HA分泌量减去来自未处理的处理物的HA分泌的量，计算得出每个测试的处理物的净HA分泌。然后，用应用组合的光加活性处理分泌的净HA除以单独用光处理的净HA分泌的净HA得到的倍数变化，即为由光+活性物质处理的组合提供的倍数增加。
可将局部用组合物和光同时或顺序施用于皮肤。顺序施用时，可将组合物和光以任意次序施用。另外与超声能量一起施用时，可将组合物、光和超声能量同时或以任意次序施用。
在本发明的一个实施方案中，需要进行皮肤老化迹象处理的皮肤的处理方式为：向皮肤局部施用包含至多约2重量％的葡糖胺盐酸盐的组合物，以及使用光递送装置将皮肤暴露于峰值波长为约600nm至约750nm的红光和/或峰值波长为约750nm至约1000nm的近红外光。
在本发明的另一个实施方案中，需要进行保湿处理的皮肤的处理方式为：向皮肤局部施用包含至多约2重量％的葡糖胺盐酸盐的组合物，以及使用光递送装置将皮肤暴露于峰值波长为约600nm至约750nm的红光和/或峰值波长为约750nm至约1000nm的近红外光。
以下非限制性实施例将进一步说明本发明。
实施例1
采用上文描述的体外方法比较以下测试处理对于产生透明质酸的活性，使用未处理的样本作为对照物：a)633nm红光和830nm红外光(各0.3J/cm2)的组合，b)633nm红光和830nm红外光(各3J/cm2)的组合，c)细胞培养基溶液中的0.02％葡糖胺盐酸盐，d)细胞培养基溶液中的0.2％葡糖胺盐酸盐，e)同时施用红光和红外光(各0.3J/cm2)的组合以及细胞培养基溶液中的0.02％葡糖胺盐酸盐，以及f)同时施用红光和红外光(各3J/cm2)的组合以及细胞培养基溶液中的0.2％葡糖胺盐酸盐。
结果如表1所示。
表1
相比于用光单独处理，红光和近红外光与葡糖胺盐酸盐的组合的处理协同增加了人真皮成纤维细胞中的透明质酸分泌。
实施例2
使用与实施例1相同的测试方法，将表2中所示的处理应用于人真皮成纤维细胞。使用葡糖胺磷酸盐代替葡糖胺盐酸盐。
未观察到协同效应。
表2
实施例3
使用与实施例1相同的测试方法，将表3中所示的处理应用于人真皮成纤维细胞。使用N-乙酰基葡糖胺代替葡糖胺盐酸盐。
未观察到协同效应。
表3
实施例4
使用表4中所示的成分，通过调节氢氧化钠的量将pH值保持在4至5.5范围内，制备包含葡糖胺盐酸盐的局部用组合物。pH高于5.5的那些组合物在60℃下放置7天或在50℃下放置30天之后，目视评估外观和颜色，发现它们是物理不稳定的。
表4
实施例5
使用表5和表6中所示的成分来制备在受权利要求书保护的本发明中使用的两种局部用组合物。表5的局部用组合物包含0.1重量％的亚硫酸氢钠。表6的局部用组合物不包含亚硫酸氢钠。
使用实施例4中所述的方法测试物理稳定性时，与表6的组合物相比，表5的组合物显示出改善的颜色和外观。
表5
表6
还制备了表7的组合物。组合物A和组合物B包含BHT或生育酚乙酸酯(已知的抗氧化剂)，而不是亚硫酸氢钠(组合物C)。然而，当以实施例4中示出的方式测试时，组合物A和组合物B均未表现出相对于组合物C的物理稳定性改善。
表7
Claims (30)
1.一种增加皮肤产生透明质酸的方法，所述方法包括向此类皮肤局部施用包含至多约2重量％的葡糖胺盐酸盐的局部用组合物，以及使用光递送装置将所述皮肤暴露于峰值波长为约600nm至约750nm的红光和/或峰值波长为约750nm至约1000nm的近红外光。
2.根据权利要求1所述的方法，其中所述皮肤暴露于所述红光和所述近红外光两者。
3.根据权利要求1所述方法，其中所述局部用组合物具有约3.0至约5.5的pH。
4.根据权利要求1所述的方法，其中所述光的强度低于约20mW/cm2。
5.根据权利要求1所述的方法，还包括将所述皮肤暴露于超声能量。
6.根据权利要求5所述的方法，其中所述光递送装置递送光和超声能量。
7.一种处理皮肤的方法，所述方法包括向需要处理皮肤老化迹象的皮肤局部施用包含至多约2重量％的葡糖胺盐酸盐的局部用组合物，以及使用光递送装置将所述皮肤暴露于峰值波长为约600nm至约750nm的红光和/或峰值波长为约750nm至约1000nm的近红外光。
8.根据权利要求7所述的方法，其中所述皮肤暴露于所述红光和所述近红外光两者。
9.根据权利要求7所述的方法，其中所述皮肤老化迹象为细纹和皱纹。
10.根据权利要求7所述的方法，其中所述局部用组合物具有约3.0至约5.5的pH。
11.根据权利要求7所述的方法，其中所述光的强度低于约20mW/cm2。
12.根据权利要求7所述的方法，还包括将所述皮肤暴露于超声能量。
13.根据权利要求12所述的方法，其中所述光递送装置递送光和超声能量。
14.一种处理皮肤的方法，所述方法包括向需要保湿的皮肤局部施用包含至多约2重量％的葡糖胺盐酸盐的局部用组合物，以及使用光递送装置将所述皮肤暴露于峰值波长为约600nm至约750nm的红光和/或峰值波长为约750nm至约1000nm的近红外光。
15.根据权利要求14所述的方法，其中所述皮肤暴露于所述红光和所述近红外光两者。
16.根据权利要求14所述的方法，其中所述皮肤老化迹象为细纹和皱纹。
17.根据权利要求14所述的方法，其中所述局部用组合物具有约3.0至约5.5的pH。
18.根据权利要求14所述的方法，其中所述光的强度低于约20mW/cm2。
19.根据权利要求14所述的方法，还包括将所述皮肤暴露于超声能量。
20.根据权利要求19所述的方法，其中所述光递送装置递送光和超声能量。
21.一种试剂盒，所述试剂盒包括：(a)包含至多约2重量％的葡糖胺盐酸盐的局部用组合物，以及(b)递送峰值波长为约600nm至约750nm的红光和/或峰值波长为约750nm至约1000nm的近红外光的光递送装置。
22.根据权利要求21所述的试剂盒，其中所述光递送装置递送所述红光和所述近红外光两者。
23.一种局部用组合物，所述局部用组合物包含约0.1重量％至约2重量％的葡糖胺盐酸盐和至少一种pKa为约2.5至约4.5的化合物，所述组合物具有小于约5.5的pH。
24.根据权利要求23所述的组合物，还包含亚硫酸氢钠。
25.根据权利要求23所述的组合物，其中pKa为约2.5至约4.5的所述化合物选自柠檬酸、乳酸、乙醇酸、琥珀酸以及它们的混合物。
26.一种包含局部用组合物的膜，所述组合物包含约0.1重量％至约2重量％的葡糖胺盐酸盐和至少一种pKa为约2.5至约4.5的化合物，所述组合物具有小于约5.5的pH。
27.根据权利要求26所述的膜，还包含亚硫酸氢钠。
28.根据权利要求26所述的膜，其中pKa为约2.5至约4.5的所述化合物选自柠檬酸、乳酸、乙醇酸、琥珀酸以及它们的混合物。
29.根据权利要求26所述的膜，呈多层水可移除膜的形式。
30.根据权利要求26所述的膜，包括包含甘油衍生物的皮肤接触底层。
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| CN113509399A (zh) * | 2021-06-22 | 2021-10-19 | 广州恒宁生物科技有限公司 | 一种壳糖胺HCl脂质体微胶囊及其制备方法与祛黑色素应用 |
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| WO2022245784A1 (en) * | 2021-05-19 | 2022-11-24 | L'oreal | Skin contouring using photo-responsive materials |
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| CN113509399A (zh) * | 2021-06-22 | 2021-10-19 | 广州恒宁生物科技有限公司 | 一种壳糖胺HCl脂质体微胶囊及其制备方法与祛黑色素应用 |
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| CN110652658B (zh) | 2023-06-30 |
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| EP3586926B1 (en) | 2021-01-06 |
| JP2020002133A (ja) | 2020-01-09 |
| MX2019007788A (es) | 2019-12-30 |
| AU2019204136B2 (en) | 2024-08-01 |
| KR20200002669A (ko) | 2020-01-08 |
| BR102019013368A8 (pt) | 2022-07-26 |
| JP7483331B2 (ja) | 2024-05-15 |
| RU2019118473A3 (zh) | 2021-12-23 |
| BR102019013368A2 (pt) | 2020-01-14 |
| US20200000696A1 (en) | 2020-01-02 |
| AU2019204136A1 (en) | 2020-01-16 |
| RU2019118473A (ru) | 2020-12-14 |
| CA3047927A1 (en) | 2019-12-28 |
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