CN115843238A - 改善维生素b3化合物渗透到皮肤中的方法 - Google Patents
改善维生素b3化合物渗透到皮肤中的方法 Download PDFInfo
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- CN115843238A CN115843238A CN202180039481.5A CN202180039481A CN115843238A CN 115843238 A CN115843238 A CN 115843238A CN 202180039481 A CN202180039481 A CN 202180039481A CN 115843238 A CN115843238 A CN 115843238A
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Abstract
本发明公开了一种改善维生素B3化合物渗透到皮肤中的方法。该方法涉及如下皮肤护理方案,在该皮肤护理方案中,按顺序使用至少两种皮肤护理组合物以处理期望皮肤健康或外观有益效果的目标皮肤部分。施用至皮肤的第一组合物是含有第一浓度的维生素B3化合物的低pH皮肤护理组合物。施用至皮肤的第二皮肤护理组合物是含有比第一组合物更高浓度的维生素B3化合物的常规皮肤护理组合物。当按合适的顺序施用时,该方案导致意外高的维生素B3通量进入皮肤。
Description
技术领域
本发明大体上涉及一种改善维生素B3化合物渗透到皮肤中的方法。更具体地,本发明涉及如下皮肤护理方案,在该皮肤护理方案中,向皮肤施用含有维生素B3化合物的低pH皮肤护理组合物,然后施用含有更高量的维生素B3化合物的另一种皮肤护理组合物。
背景技术
皮肤是抵抗环境侵害的第一道防线,否则会损害敏感的下层组织和器官。例如,皮肤在生物体与其环境之间保持相对水不可渗透的屏障以防止脱水。此外,皮肤在人的身体外观中起到关键作用。一般来讲,大多数人希望具有更年轻、看起来健康的皮肤。并且对于这些人中的一些人,诉说皮肤老化迹象,诸如皮肤变薄、皱纹和老年斑是年轻消失的不期望的暗示。
内在和外在因素均可导致皮肤外观和能的下降。例如,随着皮肤自然老化,供应皮肤的细胞和血管通常会减少并且真皮-表皮连接处变平,这导致皮肤屏障功能的变薄和普遍退化。另外,生活方式选择和暴露于环境(例如,紫外线辐射、污染、香烟烟气、烟雾、风、热、低湿度、苛刻的表面活性剂、研磨剂)可能导致过早出现老年斑和不均匀的皮肤色调。因此,在现今重视青春的社会中,处理皮肤老化迹象已成为急速发展的行业。治疗范围从美容霜膏和保湿剂到各种形式的美容手术。
已知许多天然和合成的试剂用于护肤组合物中,所述护肤组合物被市售以治疗各种皮肤状况,尤其是与老化相关联的那些。一类熟知的皮肤护理剂的一个示例是维生素B3化合物诸如烟酰胺,其已在化妆品行业中用于提供多种皮肤健康有益效果。例如,US 5,833,998公开了烟酰胺用于调节皮肤的油性/光泽外观的用途,并且US 5,968,528公开了烟酰胺用于调节皮肤老化迹象的用途。最近的研究表明,含有烟酰胺的低pH组合物可以改善功效,例如,如美国专利9,833,398和美国公布2020/0009123中所述。然而,低pH烟酰胺组合物有时可因其离子化和与组合物中的其它成分络合的能力而遭受稳定性问题。因此,在低pH下用烟酰胺配制可能限制配制品灵活性。另外,不受理论的限制,据信烟酰胺的离子化形式可以抑制渗透穿过皮肤屏障,所述皮肤屏障由脂质基质中的高度角质化的角化细胞构成。
因此,期望提供一种改善维生素B3化合物的皮肤渗透的方法。还期望改善来自低pH组合物的稳定维生素B3化合物的皮肤渗透。
发明内容
一种改善维生素B3化合物的皮肤渗透的方法,包括:识别期望皮肤健康或外观有益效果的目标皮肤部分;向所述目标皮肤部分施用低pH皮肤护理组合物,其中所述低pH皮肤护理组合物包含第一浓度的维生素B3化合物;以及之后向所述目标皮肤部分施用第二皮肤护理组合物,其中所述第二皮肤护理组合物包含第二浓度的维生素B3化合物,并且所述第二浓度高于所述第一浓度。
附图说明
图1示出了皮肤渗透测定的结果。
图2示出了皮肤渗透测定的结果。
图3示出了体外低刺激测试的结果。
具体实施方式
维生素B3化合物提供皮肤健康和/或外观有益效果的能力是熟知的。然而,为了提供期望的有益效果,维生素B3化合物必须能够渗透皮肤,这通常由菲克扩散定律决定。菲克扩散定律提供了穿过皮肤的维生素B3化合物的通量与维生素B3化合物的浓度差成正比。可以使用以下公式来应用菲克定律:
J=KD(ΔC/h),
其中:
J为材料通量;
K为来自配制品的分配系数;
D为进入皮肤的扩散系数;
ΔC为浓度差;并且
H为行进的距离(例如,角质层厚度)。
因此,当向皮肤施用(例如,作为一种方案(即依次))包含不同浓度的维生素B3化合物的组合物的组合时,更低浓度组合物有效地稀释更高浓度组合物,这应导致与单独的更高浓度组合物相比穿过皮肤的烟酰胺总体通量更低。然而,已经令人惊讶地发现,通过首先向皮肤施用含有维生素B3化合物的低pH组合物,然后施用含有更高浓度烟酰胺的第二皮肤护理组合物,穿过皮肤的维生素B3化合物的通量比预期高得多,甚至在某些情况下超过更高浓度组合物的单独通量。此发现特别意外,因为低pH制剂促进维生素B3离子化更大,从而降低其预期渗透率。穿过皮肤的维生素B3的通量的此协同增加提供了许多潜在有益效果,诸如,配制品灵活性和皮肤护理组合物和/或方案的改善功效。
说明书中对“实施方案”或类似方法的引用意指与该实施方案结合描述的具体材料、特征、结构、和/或特性包括在至少一个实施方案、任选多个实施方案中,但这并不意味所有实施方案包括所描述的材料、特征、结构、和/或特性。此外,材料、特征、结构、和/或特性可以任何合适的方式结合在不同的实施方案中,并且材料、特征、结构、和/或特性可以省略或替换所描述的。因此,除非另外说明或声明不相容性,否则尽管未在组合中明确地例示,本文所述的实施方案和方面可包括其他实施方案和/或方面的元件或组件或者可与其他实施方案和/或方面的元件或组件组合。
在所有实施方案中,除非另外特别说明,否则所有百分比均按化妆品组合物的重量计。除非另外特别说明,否则所有比率均为重量比。所有范围是包括端值在内的且可组合的。有效数字的数表示既不表达对所示量的限制,也不表达对测量精确性的限制。所有数值应理解为被词“约”修饰,除非另外特别指明。除非另外指明,否则所有测量均被理解为是在大约25℃和环境条件下进行的,其中“环境条件”意指在约1个大气压和约50%相对湿度下的条件。所有数值范围是包括端值在内的更窄的范围;所描述的范围上限和下限是可互换的,以进一步形成没有明确描述的范围。
本发明的组合物可包含本文所述的基本组分以及任选的成分,基本上由其组成或由其组成。如本文所用,“基本上由...组成”是指组合物或组分可包含附加成分,只要附加成分不在本质上改变受权利要求书保护的组合物或方法的基本特征和新颖特征。如说明书和所附权利要求书中所用,除非上下文另外清楚地指明,否则单数形式“一个”、“一种”和“该(所述)”旨在也包括复数形式。
定义
如参照组合物所用的“施用(Apply或application)”意指将本发明的组合物施用或铺展到人类皮肤表面,诸如表皮上。
“化妆剂”是指旨在被擦涂、倾倒、喷洒、喷涂、引入或以其它方式施用于哺乳动物身体或其任何部位以提供美容效果的任何物质及其任何组分。化妆剂可包含通常被美国食品及药品管理局承认安全(GRAS)的物质、食品添加剂和用于非化妆消费品(包括非处方药物)的材料。
“有效量”是指足以在处理期间诱导对角质组织的积极有益效果的化合物或组合物的量。积极有益效果可为健康、外观和/或感觉有益效果,其包括独立的或组合的本文所公开的有益效果。可以使用离体和/或体外方法来展示化合物或组合物的有效量。
“改善外观”是指在皮肤外观中提供可测量的、希望的变化或有益效果,其可例如通过发红、炎症和/或斑块鳞片的减少来量化。
“低pH”意指小于5.0(例如,1.5至4.9、2.0至4.5、2.5至4.0、或3.5至4.0)的pH。确定组合物的pH的合适方法在下文中更详细地描述。
“中性pH”是指介于5.0和8.0之间的pH。
“护肤”是指调节和/或改善皮肤状况。一些非限制性示例包括通过提供更光滑、更均匀的外观和/或感觉来改善皮肤外观和/或感觉;增加皮肤的一个或多个层的厚度;改善皮肤的弹性或回弹性;改善皮肤的紧致度;和减少皮肤的油性的、有光泽的、和/或无光泽的外观、改善皮肤的水合状态或保湿状态、改善细纹和/或皱纹的外观、改善皮肤剥落或脱屑、使皮肤丰满、改善皮肤屏障特性、改善肤色、减少发红或皮肤疹斑的外观、和/或改善皮肤的亮度、光彩、或半透明性。
“护肤活性物质”是指当施用于皮肤时,向皮肤或通常存在于其中的细胞类型提供即时和/或长久有益效果的化合物或化合物的组合。护肤活性物质可调节和/或改善皮肤或其相关细胞(例如,改善皮肤弹性、水合、皮肤屏障功能,和/或改善细胞代谢)。
“护肤组合物”意指包含护肤活性物质并且调节和/或改善皮肤状况的组合物。
“协同作用”及其变型意指由两种或更多种化合物、材料和/或组合物的组合提供的效果大于它们各自单独的预期效果。例如,可以通过具有不同浓度的维生素B3化合物的两种组合物的维生素B3化合物的皮肤渗透超过预期皮肤渗透来展示协同作用。
如本文所用,“处理期”是指将材料或组合物施用至目标皮肤表面的时间长度和/或频率。
“载体对照”是指与测试组合物相同的阴性对照,不同的是其确实包含所关注的特定活性物质(例如,不包含维生素B3化合物)。
方案
本文的方法包括向期望处理的目标皮肤部分依次施用至少两种皮肤护理组合物。第一皮肤护理组合物是低pH组合物,其含有烟酰胺以及任选地,常用于化妆品皮肤护理组合物中的其它成分。低pH组合物被配制成提供皮肤健康或外观有益效果,同时提供良好的感官特性和低的皮肤刺激潜力。在施用低pH组合物之后(例如,30秒至5分钟以后)施用第二皮肤护理组合物。第二皮肤护理组合物含有比低pH组合物更高浓度的维生素B3化合物,并且任选地包含常用于皮肤护理组合物中的其它任选成分。第一组合物和第二组合物更详细地描述于下文。虽然在按顺序施用两个皮肤护理组合物的上下文中描述了本方案,但是应当理解,所述方法设想了在施用低pH组合物之后按顺序施用任何数量的皮肤护理组合物。
本发明方法涉及识别需要处理或期望处理的人的目标皮肤部分(例如,表现出皮肤老化迹象(诸如,细纹、皱纹、干燥、不均匀的皮肤色调、过度色素沉着的斑点)的皮肤部分),以及在处理期间向目标皮肤部分施用有效量的第一皮肤护理组合物和第二皮肤护理组合物。组合物的有效量可以基于使用者期望的皮肤有益效果、处理区域的大小和/或皮肤护理活性物质(例如,维生素B3化合物)的浓度而变化。在一些情况下,有效量可以在0.1g至5g(例如,0.2g至4g、0.3g至2g、或甚至0.5g至1g)的范围内。目标皮肤部分可在面部皮肤表面上(诸如前额、口周、颏、眶周、鼻部和/或面颊)或身体的另一部分(例如手、臂、腿、背、胸)。在一些情况下,可以选择目标皮肤部分,其目前不表现皮肤衰老迹象(诸如过度色素沉着的斑点或不均匀的皮肤色调),但是为通常随年龄表现出此类特征的皮肤区域。在这些情况下,可以将低pH组合物用于帮助防止发生此类不期望的皮肤特征。
所述组合物可在处理期间每天至少一次、每天两次或以每天更频繁的方式局部施用于需要处理的目标皮肤部分,并且如果需要,施用于周围皮肤。当每天两次地施用时,第一次与第二次施用相隔至少1至12个小时。通常,所述组合物可在早上和/或晚上临睡觉前施用。当根据本文的方法使用时,本发明的组合物可以改善皮肤的外观和/或功能,例如通过改善皮肤肌理。可以例如通过减小毛孔大小、减少皮肤粗糙度、减少皱纹的存在和/或大小、这些的组合等来提供皮肤肌理的改善。
处理期理想地为低pH组合物改善目标皮肤部分的外观和/或功能的足够时间。处理期通常持续至少1周(例如,约2周、4周、8周、或甚至12周)。在一些情况下,处理期可延长至多个月(即3至12个月)。在一些情况下,所述组合物在至少2周、4周、8周或12周的处理期间在一周中的大多数时间(例如,每周至少4天、5天或6天),至少每天一次或甚至每天两次施用。
施用组合物的步骤可以通过局部施用来实现。关于组合物的施用,术语“局部的”、“局部”、“局部地”是指将组合物递送到目标区域(例如,牛皮癣斑)而使对不期望处理的皮肤表面的递送最小化。组合物可施用到并且轻轻揉进皮肤区域中。组合物或皮肤病学可接受的载体的形式应被选择成有利于局部施用。虽然本文的某些实施方案设想将组合物局部施用到某一区域,但应当理解,本文的组合物可更全面地或广泛地施用到一个或多个皮肤表面。在某些实施方案中,本文的组合物可以用作多步美容方案的一部分,其中本发明的组合物可以在一种或多种其它组合物之前和/或之后施用。
低pH组合物
本文的皮肤护理组合物为旨在局部施用至人类皮肤以改善皮肤外观和/或功能的低pH组合物。在一些情况下,本发明的低pH组合物可以用于多种皮肤状况(诸如,色素沉着过度(例如,老年斑)、不均匀的皮肤色调、看起来仓白的皮肤、皮肤晦暗、红斑、干燥皮肤、皮脂分泌、粗糙纹理、细纹、皱纹、角化、这些状况的组合等)的化妆品(即非治疗性)处理。在一些情况下,低pH组合物可能特别适合用于改善过度色素沉着的斑点、不均匀的皮肤色调和/或看起来仓白的皮肤。
低pH组合物包含有效量的维生素B3化合物、可以耐受低pH环境的聚合物增稠剂、盐/酸pH缓冲体系(例如,乳酸/乳酸钠和/或乙醇酸/葡萄糖酸钠)以及任选地低分子量硅油。组合物可以任选地包含有机硅乳化剂以及通常存在于局部用皮肤护理组合物中的其他成分。不受理论的限制,据信这些成分组合提供具有良好感觉特性并且对皮肤温和的有效的皮肤护理组合物。
可以通过使用本领域技术人员已知的常规方法将所述成分与皮肤病学可接受的载体混合来制备本文的低pH组合物。低pH组合物可以各种产品形式提供,诸如,溶液、悬浮液、洗剂、霜膏、凝胶、调色剂、条棒、喷剂、气溶胶剂、软膏、清洁液体洗涤剂和固体棒、糊剂、泡沫、摩丝、剃刮膏、擦拭物、条、贴片、电动贴片、水凝胶、成膜产品、面部和皮肤面膜(带有和不带有不溶性片材)等。所述组合物形式可符合所选的具体皮肤病学可接受的载体。在一些情况下,本文的低pH组合物可以为精华液的形式。精华液是在相对浓缩制剂中的局部用皮肤护理组合物的形式,其通常具有比常规的霜膏或洗剂型皮肤护理组合物更低的粘度。在一些情况下,精华液可以低粘度液体的形式提供,所述低粘度液体被推向市场以具体地针对特定皮肤状况和/或用于皮肤护理方案的第一步骤中。本文的精华液产品在25℃下可以具有1厘泊(cP)至30,000cP(例如,50cP至10,000cP或100cP至7,500cP、200cP至5,000cP、或300cP至2,500cP)的动态粘度。根据下面方法部分中提供的流变学方法(RheologyMethod)来确定本文的低pH组合物的粘度。
已经发现,至少一些消费者期望具有某种透明度和不透明度平衡的皮肤护理精华液。如果精华液太透明,则其看起来太像水,并且消费者可能会怀疑产品的功效。但是如果精华液太不透明,则消费者可能认为产品将不提供从精华液中预期的清爽、清洁的感觉。因此,根据下面更详细地描述的不透明度测试(Opacity Test),本文的低pH精华液产品具有在15与75之间(例如,在20与60之间或在25与50之间)的不透明度。在一些情况下,可能期望限制在低pH精华液中存在的烃油(诸如脂肪醇)和矿物油的量,因为这些成分可以不利地增加精华液的不透明度。因此,可能期望提供不含或基本上不含烃油(例如,小于3%、2%、1%、0.5%、或甚至0%)的低pH精华液。合适的低pH组合物的一些非限制性示例描述于共同未决的美国序列号16/891,491中。
维生素B3化合物
本发明的组合物包含安全且有效量的维生素B3化合物用于调节多种皮肤状况,例如,如美国专利号5,939,082中所述。本文的组合物可以含有基于组合物的重量或体积的以重量计0.1%至10%(例如0.5%至5%或1%至4%)的维生素B3化合物。
如本文所用,“维生素B3化合物”是指具有下式的化合物:
其中:
R为CONH2(即烟酰胺)、COOH(即烟酸)或CH2OH(即烟醇);它们的衍生物;以及前述物质中的任一种的盐。维生素B3化合物的示例性衍生物包括烟酸酯,该烟酸酯包括非血管舒张性烟酸酯(例如烟酸生育酚酯、烟酸十四烷酯)、烟酰胺核苷、烟基氨基酸、羧酸的烟醇酯、烟酸N-氧化物和烟酰胺N-氧化物。在一些情况下,维生素B3化合物诸如烟酰胺可以在较低pH下具有改善的功效,例如,如美国专利公布号2020/0009123中所述。
在一些情况下,可能期望维生素B3化合物的环氮在组合物中和/或在施用至目标皮肤表面之前是“未络合的”(例如,化学上未结合的和/或不受阻碍的)。例如,本文的组合物可以不含或基本上不含(即,小于3%、2%、1%或甚至小于0.5%)维生素B3化合物的盐或络合物。最大程度地减少或阻止不期望的盐和/或络合物形成的示例性方法包括排除在组合物中与维生素B3化合物形成基本上不可逆的络合物或其他不期望的络合物的物质、pH调节、离子强度调节、使用表面活性剂、以及实施配制程序,其中维生素B3化合物和与之络合的物质处于不同相中。
低pH缓冲体系
当提供用于局部施用至皮肤的低pH组合物时,重要的是包含缓冲体系以在将组合物施用至皮肤之后帮助保持组合物的pH。平均而言,人类皮肤pH通常在约5.0至6.0的范围内。为了维持此pH,人类皮肤已进化出抵抗pH变化的天然缓冲体系。因此,当将低pH组合物施用至皮肤时,皮肤的天然缓冲体系将试图调节组合物的pH以匹配皮肤的天然pH。在不添加缓冲体系的情况下,低pH组合物可能无法提供期望的皮肤护理有益效果。
本文的低pH缓冲体系包含酸缓冲剂。已知多种酸可用于皮肤护理组合物中。例如,α羟基酸(例如,柠檬酸、乙醇酸、苹果酸和乳酸)、β羟基酸(例如,水杨酸和丙酸)和多羟基酸(例如,葡糖酸)通常用作剥脱剂。然而,一些酸比其他酸更强,和/或一些人可能对某些浓度的酸比其他酸更敏感。这两个因素均可能增加由含有酸的低pH组合物引起的皮肤刺激的风险。可以适合用作本文的酸缓冲剂的酸的一些非限制性示例是乳酸、葡萄糖酸、乳糖酸和/或麦芽糖酸。乳酸和葡萄糖酸可以是特别合适的,因为与其它酸相比,它们往往对皮肤相对温和(即,不太可能引起皮肤刺激)。然而,乳酸和葡萄糖酸仍足够强,以在本发明组合物中提供所需的低pH。另外,含有乳酸和/或葡萄糖酸的组合物可以提供皮肤有益效果,可以提供附加皮肤有益效果,诸如,改善皮肤的天然保湿因子和/或刺激胶原再生,以帮助改善皮肤老化的可见迹象。本文的低pH组合物可以包含0.5%至5%的合适酸缓冲剂。在一些情况下,低pH组合物可以包含0.75%至4%、1%至3%或1.5%至2.5%的酸缓冲剂。应当理解,酸缓冲剂可以容易地转化为期望酸的形式添加。例如,在本发明组合物中易于转化为葡萄糖酸的葡萄糖酸-δ-内酯和其它葡萄糖酸前体被认为是用于本发明的目的葡萄糖酸。
本文的低pH缓冲体系包含合适的盐缓冲剂,其可以取决于所选择的酸缓冲剂。例如,当酸缓冲剂为乳酸时,可能期望使用乳酸钠,并且/或者当酸缓冲剂为葡萄糖酸时,可能期望使用葡萄糖酸钠。可以适用于本文的盐的其它非限制性示例包括选自以下的附加盐缓冲剂:乳酸葡萄糖酸钙、乳酸钾、乳酸锌和葡萄糖酸钾。盐缓冲剂可以适合提供在施用至皮肤后以及施用之后至少1分钟(例如,施用之后5、10、15、30、60或甚至120分钟或更长时间)维持组合物的期望低pH的缓冲能力以便为组合物中的活性成分渗透到皮肤中提供足够时间的任何量存在。在一些情况下,盐缓冲剂可以0.25%至4%(例如,0.5%至3%、0.75%至2%或1%至1.75%)的量存在于低pH组合物中。在一些情况下,盐缓冲剂可以1:10至10:1的酸与盐的重量比存在。可能期望使用酸和/或盐缓冲剂的L-对映体形式,因为其是在体内天然存在的形式。乳酸钠可以特别适合用作盐缓冲剂,因为其也可以充当保湿剂以帮助保湿皮肤。当然,应当理解,本发明的组合物可以任选地包含已知用于在皮肤护理组合物中使用的其他pH缓冲液。
增稠剂
本文的低pH组合物包含可以耐受低pH电解环境的聚合物增稠剂。也就是说,增稠剂在酸-盐缓冲体系的存在下将不会失去其在低pH下增稠或稳定组合物的能力。已知一些常规的中和的增稠剂在较低pH下和/或在酸-盐缓冲液(例如,乳酸/乳酸钠以及葡萄糖酸/葡萄糖酸钠)的存在下降解和/或失去适当地增稠组合物的能力。例如,一些中和的增稠剂在低pH环境中降解。在另一方面,脂肪醇增稠剂诸如鲸蜡醇和硬脂醇在低pH下一般是稳定的,但是当其为精华液、浆液等形式时趋于向所述组合物赋予不期望的混浊或不透明度。还已经发现,某些阴离子聚合物增稠剂可以提供对低pH环境的适当耐受性,但是不能耐受由于酸和盐的组合形成的缓冲体系。因此,在一些情况下,本文所述的低pH组合物可能不含或基本上不含中和的增稠剂、脂肪醇增稠剂和阴离子增稠剂。所述增稠剂可以按组合物的重量计0.0001%至25%(例如,0.001%至20%、0.01%至10%、0.5%至7%、或1%或5%)的量存在。
可以单独或组合用于本文的增稠剂或水结构化剂的其他非限制性示例包括天然或合成树胶、多糖、羧酸聚合物、聚丙烯酰胺聚合物、磺化聚合物、以及这些的共聚物。另外的示例包括改性的树胶、纤维素和超吸收聚合物。术语“超吸收聚合物”应理解为意指在其干燥状态下能够自发吸收至少20倍于其自身重量的含水流体特别是水并且尤其是蒸馏水的聚合物。合适的多糖包括烷基羟烷基纤维素醚,诸如羟丙基甲基纤维素硬脂氧基醚。此材料以商品名SANGELOSE 60L和90L由Daido Chemical Corp.出售。另一种合适的多糖包括疏水改性的淀粉,诸如改性的马铃薯淀粉。此材料以商品名STRUCTURE SOLANACE由Nouryon出售。另一种聚合物包括交联聚合物,交联聚合物的单体至少部分地由丙烯酰二甲基牛磺酸单体构成,诸如例如由Clariant以商品名ARISTOFLEX SILK出售的聚丙烯酰二甲基牛磺酸钠。
现在已经发现,某些阴离子聚合物增稠剂可以提供对低pH环境的适当耐受性并且为组合物提供期望的感觉和不透明度特性。因此,阴离子增稠剂的特别合适的示例为聚丙烯酸酯交联聚合物-6,其可作为SEPIMAX ZEN从法国Seppic商购获得。
粘性降低油
在一些情况下,当将低pH组合物施用至目标皮肤部分时,阴离子聚合物增稠剂可以赋予不期望的发粘的感觉。已经发现,添加某些油(例如,低分子量烃油或硅油)可以降低或防止这种发粘的感觉。低分子量硅油可能是特别期望的,因为它们往往提供消费者更喜欢的平滑、天鹅绒般的感觉,而烃油有时可能感觉到油腻。硅油的分子量取决于其有机硅聚合物链的长度,该长度也与硅油的粘度成正比。因此,适合用于在本发明的低pH组合物中使用的低分子量硅油在25℃下具有100cSt或更小(例如,1cSt至90cSt、5cSt至50cSt或甚至10cSt至30cSt)的运动粘度。运动粘度是对硅油进行分类的常见方法,并且可以从材料供应商处获得。低分子量硅油的特别合适的示例是5cSt聚二甲基硅氧烷流体。如本文所用,术语“聚二甲基硅氧烷”意指具有下式的聚二甲基硅氧烷化合物:
第二皮肤护理组合物
用于本方案的第二皮肤护理组合物不受特别限制,并且可以包括广泛多种皮肤护理组合物,所述皮肤护理组合物包含维生素B3化合物并且适合局部施用于皮肤。第二皮肤护理组合物可以各种产品形式提供,包括但不限于溶液、悬浮液、洗剂、霜膏、凝胶、调色剂、条棒、笔状产品、喷剂、气溶胶、软膏、清洁液体洗涤剂(洗去型或免洗型)和固体棒、泡沫、粉末、摩丝、剃刮膏、擦拭物、条、贴片、水凝胶、成膜产品、面部和皮肤面膜(带有和不带有不溶性片材)、化妆品诸如基础粉底、眼线和眼影等。组合物形式可符合所选的具体皮肤病学可接受的载体(如果存在于组合物中)。
皮肤病学可接受的载体
本文的低pH和第二皮肤护理组合物可包含皮肤病学可接受的载体(“载体”)。短语“皮肤病学可接受的载体”是指所述载体适于局部施用于角质组织,具有良好的美学性质,与所述组合物中的活性物质相容,并且不引起任何不合理的安全或毒性问题。在一个实施方案中,所述载体以按所述组合物的重量计约50%至约99%、约60%至约98%、约70%至约98%、或约80%至约95%的含量存在。
载体可为多种形式。在一些情况下,组分(例如提取物、防晒活性物质、附加组分)的溶解度或分散度可决定载体的形式和特征。非限制性示例包括简单溶液(例如水性的或无水的)、分散体、乳液和固体形式(例如凝胶、条棒、可流动的固体或无定形材料)。在一些情况下,皮肤病学可接受的载体为乳液的形式。乳液可具有连续水相(例如水包油或水包油包水乳液)或连续油相(例如油包水或油包水包油乳液)。本发明的油相可包含有机硅油、非有机硅油(诸如烃油、酯、醚)以及它们的混合物。水相通常包含水和水溶性成分(例如,水溶性保湿剂、调理剂、抗微生物剂、湿润剂和/或其它护肤活性物质)。然而,在一些情况中,水相可包含不是水的组分,该组分包括但不限于水溶性保湿剂、调理剂、抗微生物剂、湿润剂和/或其它水溶性护肤活性物质。在一些情况中,组合物的非水组分包括湿润剂,诸如甘油和/或其它多元醇。
在一些情况下,本文的组合物为提供轻度且非油腻的知觉感觉的水包油(“O/W”)乳液的形式。本文的合适O/W乳液可包含按组合物的重量计大于50%的连续水相,并且剩余部分为分散的油相。水相可包含基于水相的重量计1%至99%的水,以及任何水溶性和/或与水混溶的成分。在这些情况下,分散的油相将通常以按组合物的重量计小于30%(例如,1%至20%、2%至15%、3%至12%、4%至10%、或甚至5%至8%)存在,以帮助避免油性组合物的一些不期望的感觉效果。油相可包括一种或多种挥发性油和/或非挥发性油(例如,植物油、有机硅油和/或烃油)。可适用于本发明组合物的油的一些非限制性示例公开于美国专利9,446,265和美国公布2015/0196464中。
载体可包含一种或多种皮肤病学可接受的亲水性稀释剂。如本文所用,“稀释剂”包括维生素B3化合物能够分散、溶解或以其它方式掺入其中的材料。亲水性稀释剂包括水、有机亲水性稀释剂诸如低级一价醇(例如C1-C4)和低分子量二醇和多元醇,包括丙二醇、聚乙二醇(例如分子量200g/mol至600g/mol)、聚丙二醇(例如分子量425g/mol至2025g/mol)、甘油、丁二醇、1,2,4-丁三醇、山梨醇酯、1,2,6-己三醇、乙醇、异丙醇、山梨醇酯、丁二醇、醚丙醇、乙氧基化醚、丙氧基化醚以及它们的组合。
乳化剂
当本文的组合物为乳液(例如,水包油乳液)的形式时,可能期望的是包含乳化剂以稳定乳液(即,防止乳液发生相分离)。乳化剂可以0.01%至10%(例如,0.05%至5%、或0.1%至2%)的量存在于组合物中。乳化剂可以是非离子型、阴离子型或阳离子型。在一些情况下,乳化剂可以是有机硅乳化剂。可适用于本文的乳化剂的一些非限制性示例公开于美国专利3,755,560;4,421,769;和McCutcheon的Detergents and Emulsifiers,北美版,第317-324页(1986)中。
可能适合用于本文中的乳化剂的一些其他非限制性示例包括:聚乙二醇和脂肪醇的醚、聚乙二醇和脂肪酸的酯、糖基化的聚乙二醇和脂肪酸的醚、糖基化的聚乙二醇和脂肪酸的酯、C12-30醇和甘油或聚甘油的醚、C12-30脂肪酸和甘油或聚甘油的酯、氧化烯改性的C12-30醇与甘油或聚甘油的醚、C12-30脂肪醇与蔗糖或葡萄糖的醚、蔗糖和C12-30脂肪酸的酯、季戊四醇和C12-30脂肪酸的酯、山梨醇和/或脱水山梨糖醇与C12-30脂肪酸的酯、山梨醇和/或脱水山梨糖醇与烷氧基化脱水山梨糖醇的醚、聚乙二醇和胆固醇的醚、C12-30脂肪酸与山梨醇和/或脱水山梨糖醇的烷氧基化醚的酯、以及它们的组合。一个特别有用的乳化剂类别是月桂醇的聚乙二醇醚,诸如月桂基聚氧乙烯醚-1至月桂基聚氧乙烯醚-50(例如,月桂基聚氧乙烯醚-4)。乳化剂的其他示例包括甘油、聚甘油、蔗糖、葡萄糖或山梨醇的醚;甘油、聚甘油、蔗糖、葡萄糖或山梨醇的酯;以及它们的混合物。其他特别有用的乳化剂类别是山梨醇和山梨醇酐的烷基酯,诸如聚山梨醇酯20、聚山梨醇酯21和聚山梨醇酯40。
有机硅乳化剂可能适合用于本文。还可使用直链或支链类型的有机硅乳化剂。特别有用的有机硅乳化剂包括聚醚改性的有机硅诸如KF-6011、KF-6012、KF-6013、KF-6015、KF-6015、KF-6017、KF-6043、KF-6028和KF-6038,以及聚甘油化的直链或支链硅氧烷乳化剂诸如KF-6100、KF-6104和KF-6105;全部来自Shin-Etsu。特别适合用于本文的乳化剂是PEG-11甲基醚聚二甲基硅氧烷,其可以KF-6011从Shin-Etsu获得。令人惊讶的是,发现PEG-11甲基醚聚二甲基硅氧烷乳化剂进一步降低了阴离子聚合物增稠剂的发粘感觉,从而改善了低pH组合物的总体感觉。乳化剂可以0.1%至10%(例如,1%至5%、或2%至4%)的量存在。
其他任选成分
低pH和第二皮肤护理组合物可任选地包含一种或多种常用于化妆品组合物中的附加成分(例如,着色剂、皮肤护理活性物质、抗炎剂、防晒剂、乳化剂、缓冲液、流变改性剂、这些物质的组合等),前提条件是该附加成分不会不利地改变由本发明组合物提供的皮肤健康或外观有益效果。当掺入组合物中时,附加成分应该适用于与人类皮肤组织接触,而没有不适当的毒性、不相容性、不稳定性、变应性应答等等。附加活性物质的一些非限制性示例包括维生素、矿物质、肽和肽衍生物、糖胺、防晒剂、控油剂、颗粒、类黄酮化合物、毛发生长调节剂、抗氧化剂和/或抗氧化剂前体、防腐剂、蛋白酶抑制剂、酪氨酸酶抑制剂、抗炎剂、保湿剂、剥落剂、亮肤剂、免晒美黑剂、润滑剂、抗痤疮活性物质、抗蜂窝炎活性物质、螯合剂、抗皱纹活性物质、抗萎缩活性物质、植物甾醇和/或植物激素、N-酰基氨基酸化合物、抗微生物剂和抗真菌剂。可适用于本文的皮肤护理组合物和附加成分和/或皮肤护理活性物质的一些非限制性示例描述于美国公布2002/0022040;2003/0049212;2004/0175347;2006/0275237;2007/0196344;2008/0181956;2008/0206373;2010/00092408;2008/0206373;2010/0239510;2010/0189669;2010/0272667;2011/0262025;2011/0097286;US2012/0197016;2012/0128683;2012/0148515;2012/0156146;和2013/0022557;以及美国专利5,939,082;5,872,112;6,492,326;6,696,049;6,524,598;5,972,359;和6,174,533中。
当存在时,所述任选成分可以以按所述组合物的重量计0.0001%至50%;0.001%至20%;或甚至0.01%至10%(例如,50%、40%、30%、20%、10%、5%、4%、3%、2%、1%、0.5%或0.1%)的量被包含。
方法
不透明度测试方法
此方法用于确定产品或材料的不透明度。结果以百分比报告,其中百分比越高,样品的不透明度越大。在测量不透明度之前,使用Ultra-turrax T25(来自IKA,Germany)或具有S 25N-25F分散工具(或等同物)的等同物以10,000rpm将待测试的测试组合物研磨1分钟,注意不要将空气引入样品中。通过将足够量的组合物置于提供2mm光学路径的合适透射率单元(例如,来自Konica Minolta的CM-A130矩形单元或等同物)中来制备样品。使用合适的分光光度计测量样品的不透明度,该分光光度计可以在用于该方法的整个可见光谱的CIE D65照明条件下递送三色激励值CIE XYZ(例如,可从Konica Minolta获得的CM-3600A分光光度计或等同物)。将该分光光度计设定成用2°观察仪和D65光源递送1931CIE定义的三色激励XYZ值。两组三色激励值是计算不透明度所必需的—一组产品的2mm样品单元位于白色背景的前面,另一组位于黑色背景的前面。可接受的白色背景包括不透明卡(诸如不透明卡2A型,Leneta Company,Inc,Mahwah,NJ,USA,或等同物)的白色部分,并且可接受的黑色背景是不透明卡(诸如不透明卡2A型,Leneta Company,Inc,Mahwah,NJ,USA,或等同物)的黑色部分。通过计算使用黑色背景的Y三色激励值除以使用白色背景的Y三色激励值的商并乘以100%来确定不透明度。报告不透明度,精确至整数百分比。
流变学方法
此方法提供了使用BROOKFIELD牌粘度计(例如,型号DV2T或等同物)和合适的锭子(例如,RV4或等同物)根据制造商的说明书测量组合物或材料的动态粘度的方式。应当理解,技术人员将能够根据制造商的建议来选择适当的锭子。在校准粘度计之后,将锭子浸入足够量的测试样品中(例如,足以将锭子浸没至锭子轴上的浸没标记)。将锭子的转速设定为5rpm,并且然后启动粘度计。允许所指示的粘度读数稳定的时间(大约10-30秒)。在读数稳定之后,以10秒的间隔读取5次读数。将粘度计算为5次读数的平均值。
实施例
实施例1—配制品
表1提供了本文所述的低pH皮肤护理组合物的示例。使用制备皮肤护理组合物的常规方法制备组合物。此类方法通常包括在一个或多个步骤中将各成分混合至相对均一的状态,可使用或不使用加热、冷却、施加真空等。通常,通过首先将水相材料与脂肪相材料分别混合,然后视情况混合两相以获得所期望的连续相,来制得乳液。优选地制备组合物以优化稳定性(物理稳定性、化学稳定性、光稳定性)和/或活性物质的递送。这种优化可以包括调节pH(即,调节至小于5)、排除可以与活性剂络合并因此对稳定性或递送造成负面影响的物质(例如,排除污染的铁)、使用防止络合物形成的方法(例如,适当的分散剂或双隔室包装)、使用适当的光稳定性方法(例如,掺入防晒剂/防晒霜、使用不透明包装)等。
本实施例中所测试的组合物的pH用配备有平坦表面电极/探针(例如,VWR目录20号89231-584)的ORION牌525A pH计(或等同物)来测量。将pH计的探针直接浸入组合物的纯样品中。
表1
1可从Shin-Etsu获得的KSG-16
2可从Ashland,Inc.获得的CHRONOGEN YST
3可从Lucas Meyer Cosmetics获得的PROGELINE
4可从Seppic获得的SEPIMAX ZEN
5可从Shin-Etsu获得的KF-6011
*对比实施例
表1(续)
6可从Clariant获得的ARISTOFLEX SILK
7可从Ajinomoto OmniChem获得的ELDEW SL 205
表1(续)
8可从Evonik获得的TEGO RENEWHA LACTO
9可从Evonik获得的TEGO RENEWHA MALTO
10可从Jungbunzlauer获得
11来自Corbion的PURAMEX Zn
实施例2–改善的维生素B3化合物的皮肤渗透
本实施例展示了本方案改善烟酰胺的皮肤渗透的能力。在本实施例中,向离体皮肤样品施用低pH组合物(来自表1的实施例I),然后施用第二皮肤护理组合物。此测试中使用的第二皮肤组合物包含来自Procter&Gamble Company的多种可商购获得的皮肤护理组合物。每一种第二皮肤护理组合物包含5%烟酰胺。在第一测试(汇总于下表2A)中,分析了皮肤样品以确定穿过角质层渗透到表皮中的烟酰胺的量。在第二次测试(汇总于下表2B)中,分析了皮肤样品以确定渗透到和/或渗透穿过皮肤样品的烟酰胺的总量。
皮肤渗透方法(Franz池)
来自局部施用配制品的活性物质诸如烟酰胺的体外皮肤渗透可以使用Franz扩散池测定来确定(Franz,T.J.Percutaneous absorption.On the relevance of in vitrodata.J.Invest.Dermatol.64:190-195,1975;Franz等人,The use of excised humanskin to assess the bioequivalence of topical products.SkinPharmacol.Physiol.22:276-286,2009)。Franz扩散池测定广泛用于皮肤护理行业,以评估皮肤渗透和真皮吸收安全性评估。
由在环境条件下解冻的中厚人类尸体皮肤制备皮肤样品,将该皮肤样品切割成适当大小的部分,并安装在维持在37℃下的标准静态Franz型扩散池(0.79cm2表面积)中。将大约5ml受体溶液置于每个池底部处的受体隔室中以收集渗透穿过整个皮肤样品的任何烟酰胺。受体溶液是磷酸盐缓冲盐水(PBS-pH 7.4),其包含1%聚山梨醇酯-20和0.02%叠氮化钠。将皮肤样品平衡两小时。每个处理组具有6个重复。
为了制备测试组合物,将测试组合物的等分试样掺杂大约3μCi每300mg等分试样的14C-烟酰胺。将测试组合物等分试样混合,并使用ULTIMA GOLD牌液体闪烁体(LSC)(可从PerkinElmer,Boston获得)或等同物以及合适的液体闪烁计数仪(例如,可从PerkinElmer获得的TRI-CARB 2500TR牌液体闪烁分析仪)一式三份测定总放射性。
使用正排量移液管向皮肤样品局部给药5μL测试组合物。施用玻璃棒将产品轻轻铺展在皮肤表面上(约0.79cm2)。当测试两种或更多种产品的方案时,施用间存在3分钟间隔。在测试结束时(给药后6小时),收集受体溶液并且每个皮肤样品的表面用浸泡有PBS/Tween 20的Whatman滤纸擦拭两次并用浸泡有70%/30%乙醇/水的Whatman滤纸擦拭一次,以除去未吸收(残余)的产品。通过解剖将表皮与真皮分离,然后在60℃下将表皮和真皮部分于0.50-1.25mL SOLUENE-350(可从PerkinElmer获得)中溶解过夜。如上所述,使用液体闪烁计数来定量烟酰胺皮肤渗透。在表皮样品、真皮样品和受体溶液上进行闪烁计数。表皮皮肤渗透的量是从表皮样品(包括角质层)测量的荧光的总量。总渗透是从表皮样品、真皮样品和受体隔室测量的荧光的总和。皮肤渗透数据可以表示为剂量的%和/或ug/cm2。
在本实施例中进行的皮肤渗透测试的结果汇总于表2A和表2B并且示于图1和图2。通过将菲克扩散定律应用到施用至皮肤目标部分的烟酰胺的总浓度来确定预期的烟酰胺渗透量。如在表2A和表2B中可见,该方案提供了每种情况下烟酰胺渗透的意外增加。在一些情况下,如图1和2图所示,该方案甚至提供了附加皮肤渗透结果,这通常仅从具有相同烟酰胺浓度并且因此具有相同渗透热力学势的组合物预期。然而,如在表2B中的OLAYREGENERIST CELLSCIENCE抗老化霜产品可见,并非所有组合物都会意外增加烟酰胺的皮肤渗透,即使当其作为本发明低pH组合物的方案施用。
表2A:烟酰胺渗透到表皮中(μg/cm2)
*相对于单独的第二组合物渗透,p<0.05
表2B:总烟酰胺渗透到皮肤中(μg/cm2)
*相对于单独的第二组合物渗透,p<0.05
实施例3–热力学势
本实施例定性地示出了根据本方案施用皮肤护理产品会产生较低的皮肤渗透结果的原因。在基本术语中,维生素B3从皮肤护理组合物渗透到皮肤中的热力学势与组合物中维生素B3化合物的浓度成正比。换句话说,维生素B3化合物的热力学势可以表示为维生素B3浓度与产品质量之比。并且当在方案期间将维生素B3化合物浓度不同的两种组合物混合在皮肤上时,存在稀释效果,故相对于更高浓度组合物,混合组合物的热力学势会降低。这种效果汇总于下表3,其依赖于实施例2的测量的测试组合物的皮肤渗透。如表3所示,施加在方案中的烟酰胺的皮肤渗透意外高。
表3
实施例4-不透明度
本实施例展示了本发明低pH组合物的期望不透明度特性。通常期望介于15至75之间的不透明度。如果不透明度低于15,则组合物看起来像水一样,并且消费者可能质疑其功效。但是,如果不透明度大于75,那么消费者可以认为组合物粘稠、发粘和/或其不渗透皮肤。在本实施例中测试了组合物J、M、N、P、Q R、S和T。另外,还测试了常规皮肤护理组合物(C1)的不透明度。常规组合物授予Deckner等人的美国专利5,968,528的实施例1。该测试的结果汇总于表4。如表4中可以看出,完全不含油的组合物(即,组合物J和R)不提供足够的不透明度,并且未定制以平衡油和增稠剂的量的组合物、皮肤护理活性物质和/或缓冲体系可能太不透明,如组合物C1所展示。
表4
组合物 | J | R | M | N | P | Q | S | T | C1 |
不透明度 | 6 | 6 | 37 | 66 | 31 | 58 | 33 | 30 | 84 |
实施例5-低刺激性
本实施例展示了本发明低pH组合物的低刺激可能性。在临床研究、基于细胞的体外测定和人类体内研究中测试低pH组合物,以确定组合物的相对刺激可能性。
临床研究
作为上面实施例3中所述的临床研究的一部分,要求测试受试者填写调查问卷,所述调查问卷评定与施用至他们皮肤的测试产品相关联的刺激水平。调查问卷要求测试受试者评定他们的“不刺激皮肤”的测试产品。调查问卷提供7个可能的答案:1)强烈同意;2)同意;3)略微同意;4)不知道;5)略微不同意;6)不同意;以及7)强烈不同意。用于本实施例中的测试组合物为表1的组合物G和I以及实施例3的载体对照。该测试在第4周和第8周的结果汇总于下表5。“前3”是指回答“强烈同意”、“同意”和“略微同意”的测试受试者的百分比。
表5
周 | 处理 | 前3 |
4 | 载体对照 | 97% |
4 | 组合物I | 98% |
4 | 组合物G | 97% |
8 | 载体对照 | 98% |
8 | 组合物I | 100% |
8 | 组合物G | 100% |
在第4周,98%的测试受试者同意本发明组合物不刺激皮肤,而97%的测试受试者同意载体对照物不刺激皮肤。在第8周,100%的测试受试者同意测试组合物不刺激皮肤,相比而言98%的测试受试者同意载体对照不刺激皮肤。因此,本测试的结果表明,本发明的低pH组合物可以改善皮肤外观而不刺激使用者的皮肤。
体外研究
本实施例的体外部分检查测试组合物激活可商购获得的HEK293细胞中熟知的TRPV1感官受体的能力。TRP受体(例如,TRPA1、TRPV1和TRPM8)是因其参与向中枢神经系统传递热感觉(即热和冷)而已知的感官受体。据信TRPV1还涉及参与触发皮肤感官刺激,诸如瘙痒、灼热、疼痛、麻刺、刺痛和炎症。表达特定人TRPV1受体的细胞系先前已被用于评估材料或组合物激活TRPV1的能力,尤其用于评估各种消费品配制品的灼热、麻刺、味觉和/或疼痛缓解效应。在本实施例中,向HEK293细胞预加载Fluo-4 AM(其为钙结合染料),并且使用FLIPR TETRA牌细胞筛选体系(可获得自Molecular Devices,LLC)或等同物以高通量方式用对照物质和测试组合物处理。在TRPV1离子通道激活后,钙离子进入细胞并结合Fluo-4染料,产生荧光信号,从而允许对反应定量。为了减少与TRPV1激活无关的非特异性钙动员的影响,在存在和不存在特定TRPV1抑制剂/拮抗剂化合物的情况下测量制剂反应。在存在特定拮抗剂的情况下,TRPV1受体被制剂激活的阳性信号将消失或减少,从而增加归因于制剂依赖性TRPV1激活的数据收集准确性。
TRPV1测定
为了开始测定,在含有10% FBS、高葡萄糖、L-谷氨酰胺、酚红、100ug/ml G418和丙酮酸钠的DMEM培养基中在33℃和5% CO2下使HEK293细胞生长4-5天(80%-90%融合)(参见例如Sadofsky,L.R.等人Unique Responses are Observed in Transient Receptor Potential Ankyrin 1 and Vanilloid1(TRPA1 and TRPV1)Co-Expressing Cells.Cells2014,3,616-626)。将第二代的细胞与PBS一起从组织培养容器中移除,并将分离的细胞在离心机中以低速(800-1000rpm)旋转3min以形成沉淀。除去PBS培养基,并将细胞沉淀重悬于4mL生长培养基中。添加溶解于25μL Pluronic F-127中的50μg Fluo-4 AM钙染料,并且然后将细胞在室温下伴随轻轻摇动温育1小时。通过低速离心(800-1000rpm)将细胞用45mL测定缓冲液(1×HBSS,20mM HEPES)洗涤一次,持续3分钟,并且然后重悬于10mL测定缓冲液中。将100μL等分试样(大约15×104个细胞)分配在96孔黑色平底板的每个孔中。使板在室温下静置30分钟,并且然后使用细胞筛选系统(例如,FLIPR TETRA或等同物)在λ激发488nm和λ发射514nm下记录基线荧光。将辣椒碱(350nM)用作每个板的激动剂对照,并且将离子霉素(2uM)用作阳性对照。
将测试样品制备为在测定缓冲液(w/v)中的12X(10.8%制剂)原液并使其在室温下静置1小时。然后将测试样品以14,000rpm离心3分钟。从离心的样品中移除水相并置于合适的管中,并且在测定缓冲液中1:1混合以形成6X原液。通过将分离的水相1:1与辣椒平(capsazepine)的12X原液(25uM最终浓度)混合来制备TRPV1拮抗剂组合物。将6X样品用测定缓冲液或TRPV1拮抗剂辣椒平(25uM)的6X原液以1:3稀释。将20μL稀释的组合物一式三份添加到96孔板的孔中,最终稀释为0.3%制剂。
记录直至峰值激动剂对照反应时间(通常40-50秒)的每个孔中的最大荧光值。将重复孔的值取平均值,并且然后转换为辣椒碱激动剂对照反应的百分比。将每个测试样品反应记录为在(平均测试样品反应)–(平均测试样品反应+拮抗剂)之间的差值。低于零的反应被报告为“无反应”。在本实施例中测试了表1的组合物M、N和Q。还测试了下表6A和6B所示的组合物。测试的结果汇总于表6C并示于图3,此外,其显示本发明组合物的乳酸/乳酸钠缓冲体系表现出比对比的低pH组合物显著更少的TRPV1激活。具体地,相对于激动剂对照,本发明组合物表现出小于10%的TRPV1激活。
表6A
1可从Symrise获得的SYMDIOL 68
2可从Corbion获得的PURAC HIPURE 90
3可从Corbion获得的PURASAL S HQ-60
4可从Seppic获得的SEPIMAX ZEN
5可从Shin-Etsu获得的KF-6011P
表6B
1可从Corbion获得的PURAC HIPURE 90
2可从Corbion获得的PURASAL S HQ-60
3可从Jungbunzlauer获得
4可从Seppic获得的SEPIMAX ZEN5可从Shin-Etsu获得的KF-6011P
表6C
体内研究
相对于使用不同缓冲体系的对比的低pH配制品,本实施例的体内部分示出了本发明组合物的低刺激可能性。本研究是使用年龄为25-54岁的女性测试受试者的单一产品盲法测试。要求测试受试者每天两次(早上和晚上)向他们的整个面部施用大约0.5g(即,1泵)的测试组合物。本研究中测试的组合物提供于上表6A。在使用1周之后,询问测试受试者所述测试组合物是否刺激皮肤。体内研究的结果汇总于下表7。如表7中可见,数据表明,相对于两个对比实施例,本发明实施例对皮肤的刺激更小。
表7
本发明1 | 本发明2 | 对比1 | 对比2 | |
不刺激皮肤 | 84.0% | 86.3% | 77% | 49.1% |
实施例/组合
1.一种改善维生素B3化合物的皮肤渗透的方法,包括:
识别期望皮肤健康或外观有益效果的目标皮肤部分;
向所述目标皮肤部分施用低pH皮肤护理组合物,其中所述低pH皮肤护理组合物包含第一浓度的维生素B3化合物;以及
之后向所述目标皮肤部分施用第二皮肤护理组合物,其中所述第二皮肤护理组合物包含第二浓度的维生素B3化合物,并且所述第二浓度高于所述第一浓度。
2.根据段落A所述的方法,其中所述低pH组合物具有介于约2.0与约5.0之间,优选地约2.5至约4.5,并且更优选地约3.0至约4.3的pH。
3.根据任一前述段落所述的方法,其中所述第二皮肤护理组合物具有约5.0至约8.0的pH。
4.根据任一前述段落所述的方法,其中所述维生素B3化合物选自由以下组成的组:烟酰胺、烟酸、烟醇、这些物质的衍生物、以及它们的组合。
5.根据段落D所述的方法,其中维生素B3化合物为烟酰胺。
6.根据段落D所述的方法,其中所述低pH组合物包含约0.01%至约3%的维生素B3化合物。
7.根据段落D所述的方法,其中所述第二皮肤护理组合物包含约2%至约10%的维生素B3化合物。
8.根据任一前述段落所述的方法,其中所述低pH缓冲体系包含选自乳酸、葡萄糖酸、乳糖酸和麦芽糖酸的酸缓冲剂以及选自乳酸钠、葡萄糖酸钠、乳酸葡萄糖酸钙和葡萄糖酸钾的盐缓冲剂。
9.根据任一前述段落所述的方法,其中所述低pH组合物中的维生素B3化合物与所述第二皮肤护理组合物中的维生素B3化合物的重量%之比为约1:10至约3:4,优选地约1:5至约1:2。
10.根据任一前述段落所述的方法,其中所述低pH组合物包含:
a)约0.1%至5%的包含酸缓冲剂和盐缓冲剂的pH缓冲体系;
b)约0.1%至5%的包含低pH耐受性增稠剂的聚合物增稠剂;以及
c)约0.1%至10%的粘性降低油,所述粘性降低油在25℃下具有100cSt或更小的粘度。
11.根据段落J所述的方法,其中所述粘性降低油是硅油,优选地聚二甲基硅氧烷。
12.根据任一前述段落所述的方法,其中所述低pH组合物还包含约0.01%至约1%的有机硅乳化剂。
13.根据任一前述段落所述的方法,其中所述第一皮肤护理组合物和所述第二皮肤护理组合物中的至少一者包含附加皮肤护理活性物质,所述附加皮肤护理活性物质选自由以下组成的组:维生素、矿物质、肽、糖胺、防晒剂、控油剂、类黄酮化合物、抗氧化剂、蛋白酶抑制剂、酪氨酸酶抑制剂、抗炎剂、保湿剂、剥落剂、亮肤剂、抗痤疮剂、抗皱剂、植物甾醇、N-酰基氨基酸化合物、抗微生物剂、抗真菌剂、以及它们的组合。
14.根据任一前述段落所述的方法,其中根据不透明度测试,所述皮肤护理组合物具有约15至约75,优选地约35至约60的不透明度。
15.根据任一前述段落所述的方法,其中根据TRPV1测定,所述低pH组合物表现出小于约10%,优选地小于约5%的TRPV1激活。
16.根据任一前述段落所述的方法,其中所述低pH组合物是皮肤护理精华液产品,所述皮肤护理精华液产品在25℃下具有约1cP至约30000cP,优选地约1000cP至约15000cP的粘度。
17.根据任一前述段落所述的方法,其中在处理期间施用所述低pH皮肤护理组合物和所述第二皮肤护理组合物不会导致对所述目标皮肤部分的皮肤刺激。
本文所公开的量纲和值不应理解为严格限于所引用的精确数值。相反,除非另外指明,否则每个此类量纲旨在表示所述值以及围绕该值功能上等同的范围。例如,公开为“40mm”的量纲旨在表示“约40mm”。
除非明确排除或以其他方式限制,否则本文中引用的每一篇文献,包括任何交叉引用或相关专利或专利申请以及本申请对其要求优先权或其有益效果的任何专利申请或专利,均据此全文以引用方式并入本文。对任何文献的引用不是对其作为与本发明的任何所公开或本文受权利要求书保护的现有技术的认可,或不是对其自身或与任何一个或多个参考文献的组合提出、建议或公开任何此类发明的认可。此外,当本发明中术语的任何含义或定义与以引用方式并入的文献中相同术语的任何含义或定义矛盾时,应当服从在本发明中赋予该术语的含义或定义。
虽然已举例说明和描述了本发明的具体实施方案,但是对于本领域技术人员来说显而易见的是,在不脱离本发明的实质和范围的情况下可作出各种其他变化和修改。因此,本文旨在于所附权利要求书中涵盖属于本发明范围内的所有此类变化和修改。
Claims (15)
1.一种改善维生素B3化合物的皮肤渗透的方法,包括:
识别期望皮肤健康或外观有益效果的目标皮肤部分;
向所述目标皮肤部分施用低pH皮肤护理组合物,其中所述低pH皮肤护理组合物包含第一浓度的维生素B3化合物;以及
之后向所述目标皮肤部分施用第二皮肤护理组合物,其中所述第二皮肤护理组合物包含第二浓度的维生素B3化合物,并且所述第二浓度高于所述第一浓度。
2.根据权利要求1所述的方法,其中所述低pH组合物具有介于2.0与5.0之间,优选地2.5至4.5,并且更优选地3.0至4.3的pH。
3.根据权利要求1所述的方法,其中所述第二皮肤护理组合物具有5.0至8.0的pH。
4.根据权利要求1所述的方法,其中所述维生素B3化合物选自由以下组成的组:烟酰胺、烟酸、烟醇、这些物质的衍生物、以及它们的组合。
5.根据权利要求4所述的方法,其中所述低pH组合物包含按重量计0.01%至3%的维生素B3化合物,并且所述第二皮肤护理组合物包含按重量计2%至10%的维生素B3化合物。
6.根据任一前述权利要求所述的方法,其中所述低pH缓冲体系还包含选自乳酸、葡萄糖酸、乳糖酸和麦芽糖酸的酸缓冲剂以及选自乳酸钠、葡萄糖酸钠、乳酸葡萄糖酸钙和葡萄糖酸钾的盐缓冲剂。
7.根据任一前述权利要求所述的方法,其中所述低pH组合物中的维生素B3化合物与所述第二皮肤护理组合物中的维生素B3化合物的重量%之比为1:10至3:4,优选地1:5至1:2。
8.根据任一前述权利要求所述的方法,其中所述低pH组合物包含:
a.0.1%至5%的包含酸缓冲剂和盐缓冲剂的pH缓冲体系;
b.0.1%至5%的包含低pH耐受性增稠剂的聚合物增稠剂;以及
c.0.1%至10%的粘性降低油,所述粘性降低油在25℃下具有100cSt或更小,优选地10cSt或更小的粘度。
9.根据权利要求8所述的方法,其中所述粘性降低油是硅油,优选地聚二甲基硅氧烷。
10.根据任一前述权利要求所述的方法,其中所述低pH组合物还包含0.01%至1%的有机硅乳化剂。
11.根据任一前述权利要求所述的方法,其中所述第一皮肤护理组合物和所述第二皮肤护理组合物中的至少一者包含附加皮肤护理活性物质,所述附加皮肤护理活性物质选自由以下组成的组:维生素、矿物质、肽、糖胺、防晒剂、控油剂、类黄酮化合物、抗氧化剂、蛋白酶抑制剂、酪氨酸酶抑制剂、抗炎剂、保湿剂、剥落剂、亮肤剂、抗痤疮剂、抗皱剂、植物甾醇、N-酰基氨基酸化合物、抗微生物剂、抗真菌剂、以及它们的组合。
12.根据任一前述权利要求所述的方法,其中根据不透明度测试,所述皮肤护理组合物具有15至75,优选地35至60的不透明度。
13.根据任一前述权利要求所述的方法,其中根据TRPV1测定,所述低pH组合物表现出小于10%,优选地小于5%的TRPV1激活。
14.根据任一前述权利要求所述的方法,其中所述低pH组合物是皮肤护理精华液产品,所述皮肤护理精华液产品在25℃下具有1cP至30000cP,优选地1000cP至15000cP的粘度。
15.根据任一前述权利要求所述的方法,其中在处理期间施用所述低pH皮肤护理组合物和所述第二皮肤护理组合物不会导致对所述目标皮肤部分的皮肤刺激。
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US11583488B2 (en) | 2023-02-21 |
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US20210369588A1 (en) | 2021-12-02 |
WO2021247496A1 (en) | 2021-12-09 |
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