CN114081852A - 改善皮肤外观的组合物和方法 - Google Patents
改善皮肤外观的组合物和方法 Download PDFInfo
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- CN114081852A CN114081852A CN202010866689.1A CN202010866689A CN114081852A CN 114081852 A CN114081852 A CN 114081852A CN 202010866689 A CN202010866689 A CN 202010866689A CN 114081852 A CN114081852 A CN 114081852A
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- skin
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- improving
- collagen
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Abstract
本发明涉及用于改善皮肤外观的组合物和方法。所述组合物至少包含水、甘油、PCA钠、赤藓醇、角叉菜胶(皱波角叉菜提取物)、黄原胶;水解胶原蛋白、六肽9和生理学上可接受的介质。所述方法包括将所述组合物施用于皮肤以改善老化皮肤的外观,增加皮肤保湿,细化皮肤毛孔以及减少老化皮肤色素沉着缺陷。
Description
技术领域
本发明涉及皮肤护理组合物和用于改善皮肤外观的方法。
背景技术
许多消费者关注其皮肤的表观特征和皮肤老化迹象,例如皱纹、皮肤松弛、雀斑、色斑、毛孔粗大。
皮肤是由若干层(真皮、表皮层、和角质层)组成的重要器官,其覆盖身体的整个表面并提供保护、感觉、免疫、代谢或体温调节功能。像其他器官一样,皮肤也会经历老化。
皮肤经历复杂的老化生理过程。内在或时间上的老化是基因程序化衰老和内源性因素引起的生化改变的结果。在皮肤中,老化过程的特征在于细胞和细胞间质的再生减慢,真皮胶原蛋白(collagen)和弹性纤维逐渐丧失,导致真皮和表皮萎缩、干燥、皮肤的弹性和紧致度降低、出现细纹和皱纹、色素沉着过多或色素沉着不足、瑕疵、色斑等。另一方面,外部老化是由于环境的侵袭,例如污染、阳光照射(包括紫外线辐射)、疾病、生活方式等。在长期暴露于这些侵袭的区域,外部老化与内在老化叠加,这就是所谓的光老化。
健康个体可以发生皮肤老化以外的其他美容性皮肤缺陷,例如:皮肤干燥、皮肤色素沉着缺陷、肤色缺陷、毛孔扩大和数量增加。
皮肤干燥是非常普遍的皮肤状况,其特征在于皮肤的最表层中缺乏适量的水。这可能会取决于遗传、后天或环境因素而发生,而与年龄无关。例如,在非常干燥的环境中,从角质层蒸发造成的水分流失是显著的,并且可能超过水分由内而外经由细胞间扩散的替代速率。
除老化色素沉着缺陷以外的皮肤色素沉着缺陷可包括例如雀斑。
无论老化过程如何,发生的肤色缺陷可包括例如由于压力、污染或睡眠不足引起的暗沉肤色,或由于皮肤过度脱落、使用皮肤刺激性产品或进行运动而引起的斑点肤色。
毛孔扩大和数量增加可能是由于例如皮脂的过量产生或毛囊体积增加。
就此而言,本发明的目的是提供一种在皮肤表面上施用的组合物,其能够提供抗皱、提升皮肤紧致度和弹性、保湿效果、改善肤色均匀度、细化皮肤毛孔和减轻皮肤色素沉着缺陷。
发明内容
本发明涉及一种用于改善皮肤外观的皮肤护理组合物,其包含生理学上可接受的介质和有效量的活性成分,基于所述活性成分的总重量,所述活性成分由以下组分组成:
-50%至99.9%,优选70%至90%的水,
-5%至20%,优选10%至15%的甘油,
-0.1%至5.0%,优选1%至4%的PCA钠(Sodium PCA),
-0.1%至3.0%,优选0.5%至2.0%的赤藓醇,
-0.1%至2.0%,优选0.3%至1.0%的角叉菜胶(皱波角叉菜提取物),
-0.1%至2.0%,优选0.2%至1.0%的黄原胶,
-0.1%至3.0%,优选0.5%至2.0%的水解胶原蛋白,以及
-0.001%至0.02%,优选0.002%至0.01%的六肽-9。
所述组合物可任选包含以下组分作为防腐剂:
-0.05%至0.3%,优选0.1%至0.2%的苯甲酸,以及
-0.05%至0.3%,优选0.1%至0.2%的山梨酸。
本发明还涉及用于改善皮肤外观的方法,其中将包含活性成分的组合物施用于皮肤表面上以提供以下美容效果:改善皮肤老化迹象例如改善皮肤弹性、改善皮肤紧致度、减少皱纹、淡化(lightening)色斑,以及细化皮肤毛孔、改善肤色均匀度、和美白(lightening)皮肤。
本发明还涉及用于改善皮肤保湿的方法,其中在至少1小时期间将包含活性成分的组合物施用于皮肤表面上。
本发明还涉及用于增加胶原蛋白I、胶原蛋白III、胶原蛋白IV和胶原蛋白XVII在皮肤组织中的表达的美容方法,其中在至少48小时期间将包含活性成分的组合物施用于皮肤表面上。
附图说明
为了说明本发明的各个方面的目的,在附图中描绘了本发明的某些实施方案。然而,本发明不限于附图中描绘的实施方案的具体安排和手段。
通过附图可以理解本发明的其他实施方案。
图1示出了采用本发明的组合物和安慰剂处理后,人体离体皮肤中胶原蛋白I的免疫染色强度。
图2示出了采用本发明的组合物和安慰剂处理后,人体离体皮肤中胶原蛋白III的免疫染色强度。
图3示出了采用本发明的组合物和安慰剂处理后,人体皮肤的保湿测试结果。
图4示出了采用本发明的组合物和安慰剂处理后,人体皮肤的保湿测试结果。
图5示出了采用本发明的组合物和安慰剂处理后,人体皮肤的弹性测试结果。
图6示出了采用本发明的组合物和安慰剂处理后,人体皮肤的弹性测试结果。
图7示出了采用本发明的组合物和安慰剂处理后,人体皮肤的弹性测试结果。
图8示出了采用本发明的组合物和安慰剂处理后,人体皮肤的弹性测试结果。
图9示出了采用本发明的组合物和安慰剂处理后,人体皮肤的紧致度测试结果。
图10示出了采用本发明的组合物和安慰剂处理后,人体皮肤的鱼尾纹测试结果。
图11示出了采用本发明的组合物和安慰剂处理后,人体皮肤的毛孔数量测试结果。
图12示出了采用本发明的组合物和安慰剂处理后,人体皮肤的毛孔面积测试结果。
图13示出了采用本发明的组合物和安慰剂处理后,人体皮肤的红度测试结果。
图14示出了采用本发明的组合物和安慰剂处理后,人体皮肤的色斑测试结果。
图15示出了采用本发明的组合物和安慰剂处理后,人体皮肤的肤色测试结果。
具体实施方式
本公开提供了用于改善皮肤外观的新型皮肤护理组合物。令人惊奇地发现,所述组合物在改善皮肤弹性、改善皮肤紧致度、减少皱纹、细化皮肤毛孔、改善肤色均匀度和淡化色斑方面具有良好的效果。
活性成分
组合物的活性成分包含(a)序列(Gly-Pro-Gln)2-NH2的合成六肽,其在专利文件US 7,211,269和WO2003007905中公开。该肽旨在增加皮肤细胞的粘附,并具有减少皱纹和修复皮肤的作用。该肽的INCI名称为六肽-9(Hexapeptide-9)。
六肽-9由Ashland以商品名CollaxylTM出售。
组合物的活性成分还包含(b)以下化合物的混合物:水、甘油、PCA钠(吡咯烷酮羧酸钠)、赤藓醇、角叉菜胶(皱波角叉菜提取物)和黄原胶。
该混合物被描述为有效地水润(hydrate)皮肤。
组合物的活性成分最后包含(c)水解胶原蛋白。这些胶原蛋白寡肽与胶原蛋白I和胶原蛋白III的增加相关,并促进人体皮肤中透明质酸的表达。
作为水解胶原蛋白的实例,可以列举海洋来源的低分子量胶原蛋白寡肽,更具体地,Ashland以INCI名称水(和)水解胶原蛋白(Water(and)Hydrolyzed Collagen)出售的Marine Hydrolyzed Collagen LMWTM。
一方面,本公开提供了一种皮肤护理组合物,其包含生理学上可接受的介质和有效量的活性成分,所述活性成分由以下组分组成,浓度以相对于所述活性成分总重量的重量百分比表示:
-50%至99.9%,优选70%至90%的水,
-5%至20%,优选10%至15%的甘油,
-0.1%至5.0%,优选1%至4%的PCA钠,
-0.1%至3.0%,优选0.5%至2.0%的赤藓醇,
-0.1%至2.0%,优选0.3%至1.0%的角叉菜胶(皱波角叉菜提取物),
-0.1%至2.0%,优选0.2%至1.0%的黄原胶,
-0.1%至3.0%,优选0.5%至2.0%的水解胶原蛋白,
-0.001%至0.02%,优选0.002%至0.01%的六肽-9,
-任选存在的0.05%至0.3%,优选0.1%至0.2%的苯甲酸,以及
-任选存在的0.05%至0.3%,优选0.1%至0.2%的山梨酸。
在一个实施方案中,水解胶原蛋白是海洋来源的低分子量水解胶原蛋白。
在另一个实施方案中,组合物包含由以下列举的化合物组成的活性成分:
81.696%的水,
12%的甘油;
2.7%的PCA钠;
0.9%的赤藓醇;
0.6%的角叉菜胶(皱波角叉菜提取物);
0.3%的黄原胶;
0.18%的苯甲酸;
0.12%的山梨酸;
1.5%的水解胶原蛋白;
0.004%的六肽-9。
制备活性成分的过程包括以下步骤:在干净的容器中加水,加热至80-85摄氏度并保持30分钟,然后冷却至室温。开始混合,在漩涡中慢慢撒上黄原胶、角叉菜胶,混合直至完全溶解。加入甘油、PCA钠、赤藓醇、苯甲酸、山梨酸、六肽-9和水解的海洋胶原蛋白,每次加入后充分搅拌直至均匀。
本发明的活性成分的一个优点是提供易于配制的复合组合物。活性成分是水溶性的,易于配制成水基配方(面膜、精华液(serum)、透明化妆水(lotion)等)和乳液型制剂。
定义
每当通过范围来定义术语时,该范围将被理解为明确公开了其每个单元。作为非限制性实例,1-10%的范围将被理解为包括1%、2%、3%、4%、5%、6%、7%、8%、9%和10%,以及1到10%之间的所有值。
当两个或多个替代物(substituents)被称为“选自”一组列举的备选物时,是指每个替代物可以是该组的任何元素,而与其他替代物的认定(identity)无关。
如本文所用,除非另外提供,“%”是指重量%,即组分相对于组合物总重量(即,包括任何载体、媒剂、溶剂、填料或在施用于皮肤之前添加的其他组分)的重量百分比。
除非另外提供,否则本文中使用的所有术语旨在具有其普通含义。为了描述和要求保护本发明的目的,定义了以下术语:
在本公开中描述和使用的组合物可以“包含”本文所述的必需组分和任选存在的组分,“基本上由”本文所述的必需组分和任选存在的组分“组成”,或“由”本文所述的必需组分和任选存在的组分“组成”。如本文所用,“基本上由……组成”是指所述组合物或组分可以包括另外的成分,但是前提是所述另外的成分不实质上改变所要求保护的组合物或方法的基本和新颖特征。
当用于皮肤护理组合物时,“施用(Apply)”或“施用(Application)”是指将本发明的组合物施用或铺展在人体皮肤表面如表皮上。
如本文所用,“生理学上可接受的介质”是指在本公开的皮肤护理组合物中,适用于与人体皮肤组织接触而无毒性、不相容性、不稳定性、过敏反应等的介质,该介质能够施用于哺乳动物或人类的脸部或身体的皮肤、体被或嘴唇。
如本文所用,“改善老化皮肤的外观”是指在皮肤外观和/或感觉上产生视觉和/或触觉可感知的积极变化或益处。
如本文所用,“改善皮肤老化迹象”是指防止或延迟皮肤老化的外观。可提供的益处包括但不限于以下中的一项或多项:减少皱纹和粗深纹、细纹、裂缝的出现,防止丧失皮肤弹性和紧致度,改善色斑或与皮肤老化有关的任何其他色素沉着缺陷的出现等。老化迹象还包括暴露于紫外线后皮肤的任何退化,例如眼睛和嘴巴周围的细纹和面部表情纹的过早出现、和嘴唇变薄。这还意味着不会以改变的外观形式系统地表现出来的皮肤的任何内部改变,例如血管壁增厚、成纤维细胞的形状改变,胶原蛋白合成的减慢和胶原蛋白原纤维的紊乱,含有弹性蛋白(日光性弹力组织变性)的异常和无定形物质的积聚。
如本文所用,“皮肤毛孔细化”或“细化皮肤毛孔”是指减小被处理区域中的皮肤毛孔大小、可见毛孔数和毛孔面积。
如本文所用,“改善肤色均匀度”是指导致皮肤着色均匀性改善、皮肤红度减少的任何改变。“改善肤色均匀度”还包括改善暗沉和斑点肤色。
“皮肤美白”是指降低色素过度沉着的皮肤区域(例如雀斑、色斑、日光性雀斑样痣或任何其他皮肤色素沉着缺陷)的颜色强度。
如本文所用,“活性成分”是指以下组分的混合物:水、甘油、PCA钠(吡咯烷酮羧酸钠)、赤藓醇、角叉菜胶(皱波角叉菜提取物)、黄原胶、水解胶原蛋白、六肽-9,和任选存在的苯甲酸和山梨酸。其可以同等命名为NatrianceTM Ageless或Natriance ageless。
如本文所用,“另外的活性剂”是指具有与本文所公开的活性成分相似和/或互补的美容效果的任何美容剂。
如本文所用,“有效量”是指组合物的量足以显著诱导积极的外观和/或感官益处,但又足够低以避免严重副作用(即,在本领域技术人员的合理判断范围内提供合理的益处/风险比率)。
如本文所用,“防腐剂”是指用于防止微生物生长或不希望的化学变化并适用于美容组合物的物质,例如苯甲酸和山梨酸。
如本文所用,“皮肤保湿”是指皮肤上层的水含量。
如本文所用,术语“弹性和紧致度”是指皮肤抵抗诸如重力的外部物理应力并从中恢复的能力。
如本文所用,术语“皮肤红斑”是指通常由皮肤敏感引起的皮肤红度,其发生在健康个体中并且与病理性疾病无关。
明显的是,本发明一般涉及哺乳动物,更具体地涉及人类。
护肤组合物
在一个实施方案中,组合物在生理学可接受的介质中以1至10%(w/w)的浓度包含活性成分Natriance ageless。
在一个实施方案中,组合物在生理学可接受的介质中以1至5%(w/w)的浓度包含活性成分Natriance ageless。
根据本公开可使用的组合物适合于表面施用,并且本领域技术人员将对组合物的制剂进行调整。
本文所用的表面施用的含义是在皮肤表面上或在粘膜上施用或铺展皮肤护理组合物。
特别地,皮肤护理组合物可以为水溶液、水-醇溶液或油溶液、水包油乳液或油包水乳液的形式。它们也可以悬浮体或均匀粉末的形式呈现,适合施用于皮肤、粘膜、嘴唇和/或毛发。
这些组合物可以或多或少地为流体,并且还可以具有乳膏、化妆水、乳状物、精华、发油、凝胶、糊剂或泡沫的外观。它们也可以以固体形式以棒状存在,或者可以以气雾剂形式施用于皮肤。
在设想的应用领域中通常使用的生理学上可接受的介质的实例包括制剂所必需的添加剂,例如溶剂、增稠剂、稀释剂、抗氧化剂、着色剂、防晒剂(sun filters)、自晒黑剂、颜料、填料、防腐剂、香精、除味剂(odor absorbers)、精油、维生素、必需脂肪酸、表面活性剂、成膜聚合物(filmogenic polymers)等。
在任何情况下,本领域技术人员将确保选择这些添加剂及其比例,以不损害根据本发明的组合物所寻求的有利性能。这些添加剂可以例如相应于组合物总重量的0.01%至20%。当根据本发明的组合物是乳液时,相对于组合物的总重量,油相可以占5-80%,优选5-50%。组合物中使用的乳化剂和辅助乳化剂选自所述领域中常规使用的那些。例如,它们可以以相对于组合物总重量的0.3%至30%的比例使用。
根据本发明的另一个有利的实施方案,可以将皮肤护理组合物包封或包含在美容载体中,例如脂质体或在美容领域中使用的任何其他纳米胶囊或微胶囊,或吸附在粉状有机聚合物或无机载体上,例如滑石和膨润土。
皮肤护理组合物可进一步包含至少一种其他活性剂,其具有与本发明的活性成分相似和/或互补的美容效果。如本文所用,该活性成分被定义为“另外的活性剂”。
例如,(一种或多种)另外的活性成分可以选自:抗老化物质、紧致物质、提亮物质、保湿物质、排水物质、促进微循环的物质、去角质的物质、脱皮的物质、细胞间质的物质、激活能量代谢的物质、抗细菌物质、抗真菌物质、舒缓物质、抗自由基物质、抗紫外线物质、抗粉刺物质、抗炎物质、诱导热感或新鲜感的物质、以及减肥物质。
这种另外的活性剂可以选自:
-维生素A,尤其是视黄酸、视黄醇、丙酸视黄醇酯、棕榈酸视黄醇酯;
-维生素B3,尤其是烟酰胺、烟酸生育酚酯;
-维生素B5、维生素B6、维生素B12、泛醇;
-维生素C,特别是抗坏血酸、抗坏血酸基葡糖苷、抗坏血酸基四棕榈酸酯、抗坏血酸基磷酸镁和抗坏血酸基磷酸钠;
-维生素E、F、H、K、PP、辅酶Q10;
-金属蛋白酶抑制剂或TIMP激活剂;
-DHEA、其前体和衍生物;
-氨基酸如精氨酸、鸟氨酸、羟脯氨酸、羟脯氨酸二棕榈酸酯、棕榈酰甘氨酸、羟赖氨酸、甲硫氨酸及其衍生物、N-酰基氨基酸化合物;
-天然或合成的肽,包括二肽、三肽、四肽、五肽和六肽及它们的亲脂性和异构体衍生物,以及它们与其他物质(例如金属离子(例如铜、锌、锰、镁等)络合的衍生物。实例包括商业上以名称CHRONOGENTM、LAMINIXYL ISTM、PEPTIDEQ10TM、PEPTIDE VINCI 01TM(专利FR2837098,)、PEPTIDE VINCI 02TM(专利FR2841781,)、ATPeptideTM(专利FR2846883,)已知的肽,或还有序列Arg-Gly-Ser-NH2的合成肽(由以ATPeptideTM的名称出售);
-脱氢乙酸(DHA);
-合成或天然来源的植物甾醇;
-水杨酸及其衍生物、α-羟基酸和β-羟基酸、硅烷醇;
-氨基糖、葡糖胺、D-葡糖胺、N-乙酰基葡糖胺、N-乙酰基-D-葡糖胺、甘露糖胺、N-乙酰基甘露糖胺、半乳糖胺、N-乙酰基半乳糖胺;
-多酚提取物、异黄酮提取物、类黄酮提取物,例如葡萄提取物、松树提取物、橄榄提取物;
-脂质,例如神经酰胺或磷脂,动物来源的油,例如角鲨烯或角鲨烷;植物油,例如甜杏仁油、椰子油、蓖麻油、霍霍巴油、橄榄油、油菜油、花生油、葵花籽油、小麦胚芽油、玉米胚芽油、大豆油、棉油、苜蓿油、罂粟油、南瓜油、月见草油、小米油、大麦油、黑麦油、红花油、西番莲油、榛子油、棕榈油、杏仁油、鳄梨油、金盏花油;乙氧基化植物油、乳木果油;
-所有的紫外线防护剂和防晒剂;
-环状AMP及其衍生物、作为腺苷酸环化酶激活剂的物质和作为磷酸二酯酶抑制剂的物质、积雪草(Centella asiatica)提取物、积雪草苷和积雪草酸、甲基黄嘌呤、咖啡碱、咖啡因及其衍生物、茶碱、可可碱、福司柯林、七叶甙(esculin)和七叶灵(esculosid)、ACE抑制剂、Val-Trp肽、神经肽Y抑制剂、脑啡肽、银杏叶提取物、薯蓣属提取物、芦丁、巴拉圭茶提取物、瓜拉那提取物、低聚糖、多糖、肉毒碱、常春藤提取物、墨角藻提取物、夏枯草的水解提取物、鸡冠花的水解提取物、榆绿木(Anogeissus leiocarpus)提取物、木薯(Manihotutilissima)的叶提取物、棕榈酰肉毒碱(palmitoyl camitine)、肌肽、牛磺酸、接骨木提取物、海藻提取物(例如红藻提取物)。
用于改善皮肤外观的美容方法
根据本公开,出乎意料地发现,本文所述的组合物改善了皮肤以下的几个方面:增加皮肤弹性、增加皮肤紧致度、细化皮肤毛孔、减少皮肤皱纹、改善肤色均匀度、以及美白皮肤和淡化色斑。
在一个方面,本公开涉及一种用于改善皮肤外观的美容方法,其中将上述组合物施用于皮肤表面,并且其中在皮肤上的效果选自以下皮肤老化迹象:改善皮肤弹性、改善皮肤紧致度、减少皱纹、淡化色斑。
在这个方面,有利地,所述组合物在生理学上可接受的介质中以1-5%(w/w)的浓度包含活性成分Natriance ageless,并且施用至少28天。
在这个方面,有利地,所述组合物在生理学上可接受的介质中以5%(w/w)的浓度包含活性成分Natriance ageless,并且施用至少28天。
在另一个实施方案中,本公开涉及用于改善皮肤外观的美容方法,所述方法包括将上述组合物施用于皮肤表面,其中在皮肤上的效果包括:细化皮肤毛孔、改善肤色均匀度、美白皮肤。
在这个方面,有利地,所述组合物在生理学上可接受的介质中以1-5%(w/w)的浓度包含活性成分Natriance ageless,并且施用至少28天。
在这个方面,有利地,所述组合物在生理学可接受的介质中以5%(w/w)的浓度包含活性成分Natriance ageless,并且施用至少28天。
另一方面,本公开涉及用于改善皮肤保湿的美容方法,该方法包括将上述组合物施用于皮肤表面。
在这个方面,有利地,所述组合物在生理学上可接受的介质中以1-5%(w/w)的浓度包含活性成分Natriance ageless,并施用1-5小时。
在这个方面,有利地,所述组合物以5%(w/w)的浓度包含活性成分Natrianceageless。
另一方面,本公开涉及用于增加胶原蛋白I、胶原蛋白III、胶原蛋白IV和胶原蛋白XVII的表达的美容方法,该方法包括将上述组合物每天施用两次,持续48小时。
在这个方面,该组合物有利地在生理学上可接受的介质中以1-5%(w/w)的浓度包含活性成分Natriance ageless。
实施例1:活性成分Natriance Ageless的制备
在干净的容器中加水,加热至80-85摄氏度并保持30分钟,然后冷却至室温。开始混合,在漩涡中慢慢撒上黄原胶、角叉菜胶,混合直至完全溶解。加入甘油、PCA钠、赤藓醇、苯甲酸、山梨酸、六肽-9和水解胶原蛋白,每次加入后充分搅拌直至均匀。
下表1显示了制备活性成分NatrianceAgeless时用到的各化合物的列表和浓度。
表1
制得的活性成分Natriance Ageless的典型性能:
外观:轻微雾状粘性液体
pH值:4.0-5.0(原样)
粘度:3,000-20,000cps(Brookfield RVDV-II+,05#@10rpm)
实施例2:离体皮肤中胶原蛋白I和III的免疫染色
方案:
在特定培养基(DMEM 1g/L,HAMF12,胎牛血清和抗生素)中离体维持直径6毫米的正常人皮肤活检。用在聚丁二酸丁二醇酯(PBS)中以1%、3%和5%的浓度稀释的实施例1的活性成分处理活检样品,一日两次,持续48小时。将稀释的活性成分施加到皮肤活检样品的表面上。通过应用PBS 1X(纯的聚丁二酸丁二醇酯)代替经稀释的活性成分进行安慰剂对照。
为了通过胶原蛋白I和胶原蛋白III抗体进行免疫标记,将组织固定并包埋在石蜡中。然后切开被包埋的皮肤活检样品,将切片去石蜡并重新水化。然后,在应用特异性抗胶原蛋白I抗体(abcam,ab34710,兔多克隆抗体)或特异性抗胶原蛋白III抗体(Tebu-Rockland,600-401-105,兔多克隆抗体)之前,进行暴露方案,然后进行与荧光染料偶联的合适的二抗。在特定介质中固定后,通过落射荧光显微镜(Zeiss Axiovert 200M显微镜)观察载玻片,同时通过学生T检验进行统计学分析。实验结果如图1和图2所示。
结果:
图1示出了采用本发明的组合物和安慰剂处理后,人体离体皮肤中胶原蛋白I的免疫染色强度。如图1所示,与采用安慰剂处理48小时相比,用以1%和5%的浓度稀释的实施例1的活性成分处理后,分别显示离体皮肤活检中胶原蛋白I的表达高显著性的增加(+18%)和显著的增加(+10%)。采用3%的浓度稀释的实施例1的活性成分与采用安慰剂处理的结果无显著差异,这可能是操作误差导致的。
图2示出了采用本发明的组合物和安慰剂处理后,人体离体皮肤中胶原蛋白III的免疫染色强度。如图2所示,在离体皮肤活检中胶原蛋白III的表达中,用1%和5%的浓度稀释的实施例1的活性成分处理48小时,显示出高显著性的增加,以及以3%的浓度稀释的实施例1的活性成分显示出非常显著的增加。
结论:
实施例1的活性成分通过刺激胶原蛋白I和胶原蛋白III,改善了对于对抗老化重要的细胞外基质结构。
实施例3:皮肤保湿的临床研究
方案:
24名亚洲男性和女性志愿者,双盲测试,皮肤干燥,前臂掌侧的含水量值低于40。在前臂掌侧选择2个3cm*5cm的区域,按照随机化的规则,以2mg/cm2的剂量用表2所示的测试产品(参见实施例1中公开的制剂,5%的Natriance Ageless,以及安慰剂)处理选出的测试区域。在0小时、1小时、3小时和5小时(T0、T1、T3、T5),采用Comeometer CM825测试皮肤含水量,并且采用Tewameter TM300测试皮肤的表皮水分流失(TEWL)。通过学生T检验(单尾)进行统计学分析。
表2:测试产品的配方
测试产品的制备程序:
1.在烧杯中加入水并加热至65℃,加入C相组分并开始搅拌,直至料体均一透明;
2.将烧杯中的料体的温度降至室温,在搅拌下将卡波姆和EDTA-2Na撒入旋涡并持续搅拌,直至料体均一;
3.在搅拌下加入10重量%的氢氧化钠水溶液,持续搅拌,直至料体均一;以及
4.加入D相组分并持续搅拌,直至料体均一。
结果:
图3示出了采用本发明的组合物和安慰剂处理后,人体皮肤的保湿测试结果。如图3所示,在1h、3h和5h之后,与采用安慰剂处理的情况相比,以5%的Natriance Ageless(实施例1的活性成分)处理的人体皮肤在统计学上显著地增加皮肤含水量。Δ皮肤含水量值为1h、3h和5h之后的皮肤含水量与0h时的皮肤含水量之差。图3中的百分数通过5%的Natriance Ageless的Δ皮肤含水量值与安慰剂的Δ皮肤含水量值之差,除以安慰剂的Δ皮肤含水量值的绝对值得到。“p”表示标准偏差与平均值之商。
图4示出了采用本发明的组合物和安慰剂处理后,人体皮肤的保湿测试结果。如图4所示,在1h和5h之后,与采用安慰剂处理的情况相比,以5%的Natriance Ageless处理的人体皮肤在统计学上显著地降低TEWL。ΔTEWL为1h、3h和5h之后的TEWL与0h时的TEWL之差。图4中的百分数通过5%的Natriance Ageless的ΔTEWL与安慰剂的ΔTEWL之差,除以安慰剂的ΔTEWL的绝对值得到。“p”表示标准偏差与平均值之商。
结论:
Natriance Ageless(实施例1的活性成分)可以改善皮肤的瞬时含水量,并通过增强皮肤屏障功能有效减少表皮水分流失。
实施例4:确定Natriance Ageless皮肤益处的临床研究
方案:
30名亚洲受试者(具有皱纹和松弛皮肤,年龄47.97±5.71),在脸上双盲测试。按照随机化的规则,以2mg/cm2的剂量用表3所示的测试产品(参见实施例1的活性成分,5%的Natriance Ageless制剂;和安慰剂)处理半脸。在0天、7天、14天和28天时,使用Visia CR进行全脸成像,用Primos拍摄皮肤的鱼尾纹皱纹照片,使用Cutometer测试皮肤弹性和紧致度强度。通过T学生测验(单尾)进行统计学分析。
表3:测试产品的配方
程序:
1.将A相成分加入烧杯中,加热至70℃并混合至均匀。
2.在B相成分加入另一烧杯中,加热至70℃并混合至均匀。
3.将C相成分加入B相中,均质化10秒钟。
4.将B+C相成分加入A相中,均质化持续3分钟。开始冷却该料体。
5.当该料体降温至35-40℃时,依次添加D相成分并混合至均匀。
结果:
图5示出了采用本发明的组合物和安慰剂处理后,人体皮肤的弹性测试结果。Cutometer数据显示,在第14天和第28天,采用5%的Natriance Ageless(实施例1的活性成分)在统计学上显著改善皮肤恢复到其原始状态的能力(R1)。
在图5至图10中,“p”表示标准偏差与平均值之商。在表示皮肤弹性值和时间时,角标“P”表示安慰剂,“A”表示5%的Natriance Ageless。
图6示出了采用本发明的组合物和安慰剂处理后,人体皮肤的弹性测试结果。Cutometer数据显示,第14天和第28天后,采用5%的Natriance Ageless(实施例1的活性成分)在统计学上显著改善总体弹性(R2)。
图7示出了采用本发明的组合物和安慰剂处理后,人体皮肤的弹性测试结果。Cutometer数据显示,第14天和第28天后,采用5%的Natriance Ageless(实施例1的活性成分)在统计学上显著改善皮肤恢复能力(R8)。
图8示出了采用本发明的组合物和安慰剂处理后,人体皮肤的弹性测试结果。Cutometer数据显示,第14天和第28天后,采用5%的Natriance Ageless(实施例1的活性成分)在统计学上显著改善皮肤总体弹性(粘弹性恢复能力,Q1)。
图9示出了采用本发明的组合物和安慰剂处理后,人体皮肤的紧致度测试结果。Cutometer数据显示,第14天和第28天后,采用5%的Natriance Ageless(实施例1的活性成分)在统计学上显著改善皮肤紧致度(粘性恢复能力,Q3)。
图10示出了采用本发明的组合物和安慰剂处理后,人体皮肤的鱼尾纹测试结果。通过Primos拍摄皮肤的鱼尾纹皱纹照片显示,在第7天和第28天,采用5%的NatrianceAgeless(实施例1的活性成分)在统计学上显著减少鱼尾纹CW。
图11示出了采用本发明的组合物和安慰剂处理后,人体皮肤的毛孔数量测试结果。通过图像分析对全脸进行的Visia CR成像显示,经过28天的处理后,采用5%的Natriance Ageless(实施例1的活性成分)提供皮肤毛孔细化效果(减少毛孔数量)。
图12示出了采用本发明的组合物和安慰剂处理后,人体皮肤的毛孔面积测试结果。通过图像分析对全脸进行的Visia CR成像显示,经过28天的处理后,采用5%的Natriance Ageless(实施例1的活性成分)提供皮肤毛孔细化效果(减少毛孔面积百分比)。
图13示出了采用本发明的组合物和安慰剂处理后,人体皮肤的红度(a*)测试结果。通过图像分析对全脸进行的Visia CR成像显示,经过28天的处理后,采用5%的Natriance Ageless(实施例1的活性成分)减少皮肤红度(红斑)。
图14示出了采用本发明的组合物和安慰剂处理后,人体皮肤的色斑(色斑L*值)测试结果。通过图像分析对全脸进行的Visia CR成像显示,经过28天的处理后,采用5%的Natriance Ageless(实施例1的活性成分)淡化皮肤斑点。
图15示出了采用本发明的组合物和安慰剂处理后,人体皮肤的肤色(皮肤L*值)测试结果。通过图像分析对全脸进行的Visia CR成像显示,经过28天的处理后,采用5%的Natriance Ageless(实施例1的活性成分)美白总体肤色。
结论:
采用Natriance Ageless(实施例1的活性成分)可以改善皮肤弹性和紧致度,减少皱纹如鱼尾纹,细化皮肤毛孔,减少皮肤红斑,淡化皮肤斑点并改善肤色。
Claims (12)
1.用于改善皮肤外观的组合物,其包含生理学上可接受的介质和有效量的活性成分,基于所述活性成分的总重量,所述活性成分由以下组分组成:
-50%至99.9%,优选70%至90%的水,
-5%至20%,优选10%至15%的甘油,
-0.1%至5.0%,优选1%至4%的PCA钠(吡咯烷酮羧酸钠),
-0.1%至3.0%,优选0.5%至2.0%的赤藓醇,
-0.1%至2.0%,优选0.3%至1.0%的角叉菜胶(皱波角叉菜提取物),
-0.1%至2.0%,优选0.2%至1.0%的黄原胶,
-0.1%至3.0%,优选0.5%至2.0%的水解胶原蛋白,
-0.001%至0.02%,优选0.002%至0.01%的六肽-9,
-任选存在的0.05%至0.3%,优选0.1%至0.2%的苯甲酸,以及
-任选存在的0.05%至0.3%,优选0.1%至0.2%的山梨酸。
2.根据权利要求1所述的组合物,其中基于所述活性成分的总重量,所述活性成分由以下组分组成:
81.696%的水、12%的甘油;2.7%的PCA钠;0.9%的赤藓醇;0.6%的角叉菜胶(皱波角叉菜提取物);0.3%的黄原胶;0.18%的苯甲酸;0.12%的山梨酸;1.5%的水解胶原蛋白;以及0.004%的六肽-9。
3.根据权利要求1或2所述的组合物,其中所述活性成分的浓度范围为1-10%。
4.根据权利要求1或2所述的组合物,其中所述活性成分的浓度范围为1-5%。
5.根据权利要求1-4中任一项所述的组合物,其中所述组合物还包含至少一种另外的活性剂。
6.用于改善皮肤外观的美容方法,所述方法包括将根据权利要求1-5中任一项所述的组合物施用于皮肤表面,其中在皮肤上的效果选自改善皮肤老化迹象:改善皮肤弹性、改善皮肤紧致度、减少皱纹、淡化色斑。
7.根据权利要求6所述的方法,其中在至少28天期间施用所述组合物。
8.用于改善皮肤外观的美容方法,所述方法包括将权利要求1至5中任一项所述的组合物施用于皮肤表面,其中在皮肤上的效果包括:细化皮肤毛孔、改善肤色均匀度和美白皮肤。
9.根据权利要求8所述的方法,其中在至少28天期间施用所述组合物。
10.用于改善皮肤保湿的美容方法,所述方法包括将根据权利要求1-5中任一项所述的组合物施用于皮肤表面。
11.根据权利要求10所述的方法,其中施用所述组合物1-5小时。
12.用于增加皮肤组织中胶原蛋白I、胶原蛋白III、胶原蛋白IV和胶原蛋白XVII的表达的美容方法,其包括将权利要求1至5中任一项所述的组合物施用于皮肤表面,一日两次,持续48小时。
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