CN113453675A - 辛酸和癸酸甘油三酯用于治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症的用途 - Google Patents
辛酸和癸酸甘油三酯用于治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症的用途 Download PDFInfo
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Abstract
辛酸和癸酸甘油三酯用于治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症的用途。本发明涉及辛酸和癸酸甘油三酯、辛酸和癸酸甘油三酯与褪黑素或其衍生物的组合或含有单独的或与褪黑素或其衍生物组合的辛酸和癸酸甘油三酯的组合物用于治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症的用途。
Description
相关申请
本申请要求于2019年3月6日提交的欧洲专利申请EP19382169.1的权益。
技术领域
本发明涉及辛酸和癸酸甘油三酯、辛酸和癸酸甘油三酯与褪黑素或其衍生物的组合或含有它们的组合物用于治疗由丝聚蛋白或胶原蛋白的缺乏介导的疾病或病症的用途。
背景技术
成纤维细胞和角质形成细胞的基质组分的障碍已被鉴定为常见皮肤病症以及一些***障碍的主要原因之一。丝聚蛋白和/或胶原蛋白的量的缺乏可能由这些蛋白的异常产生或由这些蛋白质的降解增加引起。
一方面,丝聚蛋白是一种丝相关蛋白,其与上皮细胞中的在表皮屏障功能中具有关键作用的角蛋白纤维结合。该蛋白质也是表皮的蛋白质-脂质角质化包膜的主要组分,其对于透水性和阻断微生物和过敏原的进入很重要。因此,丝聚蛋白对表皮稳态的调节至关重要。
具有丝聚蛋白量的缺乏的个体强烈地倾向于罹患皮肤病,诸如干燥皮肤、寻常型鱼鳞癣和/或湿疹。这些皮肤病的特征在于线纹过多,毛发角化病,发痒、鳞状且常常发炎的皮肤。遗憾的是,无法治愈丝聚蛋白缺乏或服用丝聚蛋白补充剂。只有一些措施尝试恢复皮肤中丝聚蛋白的量。其中一些措施涉及避免肥皂、洗涤剂、洗发剂和擦洗剂和/或增加润肤剂的使用。
另一方面,胶原蛋白是一种皮肤中发现的蛋白质,其给予皮肤丰满和光滑的外观。此外,它还维持内脏、肌肉、肌腱、软骨,并且也存在于牙齿中。胶原蛋白占体内蛋白全量的25%。身体中有约20种不同类型的胶原蛋白。每组胶原蛋白在身体的许多功能中具有重要角色,诸如形成和维持内脏。特别地,III型胶原蛋白是一种纤维状胶原蛋白,其仅由一条胶原蛋白α链组成,由成纤维细胞和其他间充质细胞类型分泌。特别地,III型胶原蛋白是各种炎症相关病状,诸如肺损伤、病毒和非病毒肝病、肾纤维化、疝气和血管障碍的主要参与者。此外,III型胶原蛋白与I型胶原蛋白一起是间质基质的主要成分。
胶原蛋白对于具有健康和光滑的皮肤至关重要。负责皱纹的皮肤层是真皮,其由血管、皮脂腺和毛囊组成。胶原蛋白是真皮的支撑和弹性所必需的。胶原蛋白产生自然随着年龄的增长而降低,从而在皮肤中引起皱纹、瘢痕化和松垂皮肤的外观。当胶原蛋白的缺乏处于肌肉中时,会经历肌肉疼痛和酸痛;而如果胶原蛋白缺乏在软骨中,它会导致关节疼痛。此外,通过胶原蛋白变性介导的疾病或病症也影响皮肤、肌肉和/或软骨。这种胶原蛋白变性可以由环境因素(诸如阳光暴露)或由一些***疾病(诸如风湿热、类风湿性关节炎和狼疮等)引起。
当胶原蛋白缺乏正在影响皮肤时,它可以通过胶原蛋白注射治疗。胶原蛋白注射治疗涉及在受影响区域的皮肤下注射纯化的动物/尸体来源的胶原蛋白。同时,当胶原蛋白缺乏影响器官时,则所述治疗涉及摄取胶原蛋白补充剂(可以液体和丸剂形式利用)。此外,胶原蛋白补充剂还可以防止胶原蛋白缺乏发展它们。然而,用于胶原蛋白补充剂的处方药可能具有来源于其起源(动物或尸体来源的胶原蛋白)的副作用,诸如过敏反应。
因此,根据现有技术中所知的情况,仍然需要开发用于治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症的新化合物。
发明内容
发明人已经发现,辛酸和癸酸甘油三酯使得增加基质蛋白丝聚蛋白和胶原蛋白的表达,并且因此,局部施用特定量的辛酸和癸酸甘油三酯用作用于治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症的活性成分是有用的。
此外,发明人还已经发现,辛酸和癸酸甘油三酯与其他活性成分诸如褪黑素或其衍生物的组合用作用于治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症的活性成分也是有用的。
因此,本发明的第一方面涉及用于在治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症中使用的辛酸和癸酸甘油三酯,其中所述治疗包括局部应用治疗有效量的辛酸和癸酸甘油三酯。
另外,本发明的第二方面是指用于在治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症中使用的局部用组合物,其中所述治疗包括局部应用所述组合物,所述组合物包含占所述组合物的总重量的0.1重量%至70重量%的有效量的辛酸和癸酸甘油三酯,以及一种或多种适当的局部用可接受的赋形剂或载体。
本发明的一部分还在于用于在治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症中使用的辛酸和癸酸甘油三酯与褪黑素或其衍生物的组合、或含有它们的组合物。
具体实施方式
除非另有说明,否则本申请中如本文所用的所有术语应以本领域已知的普通含义来理解。如在本申请中使用的某些术语的其他更具体的定义如下所述,并且除非另外明确陈述的定义提供了更宽泛的定义,否则旨在在整个说明书和权利要求中统一地应用。
出于本发明的目的,给出的任何范围包括所述范围的下端点和上端点两者。除非特别说明,否则给出的范围(诸如温度、时间等)应视为近似值。
术语“重量百分比(%)”或“重量%”可互换地使用,并且它们是指组合物的每种成分相对于总重量的百分比。
如上所述,本发明的第一方面是指治疗有效量的辛酸和癸酸甘油三酯用于治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症的用途。
如本文所用的术语“治疗有效量”是指活性成分(例如辛酸和癸酸甘油三酯)的量,其在施用时足以预防待解决疾病的发展或在一定程度上减轻所述疾病的一种或多种症状。根据本发明施用的活性成分的具体剂量将通过围绕病例的特定情况确定,所述特定情况包括施用的化合物、施用的途径、所治疗的具体病症以及类似的考虑因素。
出于本发明的目的,术语“辛酸和癸酸甘油三酯”、“辛酸/癸酸甘油三酯”和缩写“CCT”具有相同的含义并且它们可互换使用。特别地,CCT是由混合酯(由辛酸和葵酸脂肪酸构成)制得的油性液体,所述混合酯由通过甘油(植物糖)与来自椰子油或棕榈仁油的辛酸(C:8)和葵酸(C:10)脂肪酸的混合物的酯化而获得。辛酸/癸酸甘油三酯以商标Miglyol812等可商购获得。
在一个实施方案中,本发明的所述使用的辛酸和癸酸甘油三酯是这样的辛酸和癸酸甘油三酯,其中疾病或病症由丝聚蛋白缺乏介导,特别地选自由银屑病、特应性皮炎和寻常型鱼鳞癣组成的组。
在一个实施方案中,本发明的所述使用的辛酸和癸酸甘油三酯是这样的辛酸和癸酸甘油三酯,其中疾病或病症由胶原蛋白缺乏介导,特别地选自由皮肤老化和皮肤光老化组成的组。
如本发明的实施例中所示,辛酸和癸酸甘油三酯促进丝聚蛋白和胶原蛋白的表达(产生),并且因此,其可用于治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症。因此,此方面还可以明确地表达为如上所定义的辛酸和癸酸甘油三酯用于制备用于治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症的药物的用途,其中所述治疗包括局部应用治疗有效量的辛酸和癸酸甘油三酯。还涉及的是一种用于治疗罹患或易于罹患由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症的哺乳动物,其中所述方法包括向所述哺乳动物施用治疗有效量的辛酸和癸酸甘油三酯,以及一种或多种药学上可接受的赋形剂或载体。
在一个实施方案中,本发明的所述使用的辛酸和癸酸甘油三酯是这样的辛酸和癸酸甘油三酯,其中所述治疗包括局部应用辛酸和癸酸甘油三酯与褪黑素或其衍生物的组合。在一个实施方案中,本发明的所述使用的辛酸和癸酸甘油三酯是这样的辛酸和癸酸甘油三酯,其中所述治疗包括局部应用辛酸和癸酸甘油三酯与治疗有效量的褪黑素或其衍生物的组合。
出于本发明的目的,术语“褪黑素”是具有下式的、具有CAS注册号73-31-4的“N-乙酰基-5-甲氧基色胺”的非专有名称、:
术语“褪黑素及其衍生物”是指具有下式的化合物:
其中R1和R2中的每一个独立地选自由H和卤素组成的组。术语“卤素”是指氟、氯、溴或碘。
如上所述,本发明的第二方面是指用于在治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症中使用的局部用组合物,其中:所述治疗包括局部应用所述组合物,所述组合物包含占所述组合物的总重量的0.1重量%至70重量%的有效量的辛酸和癸酸甘油三酯,以及一种或多种适当的局部用可接受的赋形剂或载体。
在一个实施方案中,用于在治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症中使用的组合物是这样的组合物,其中治疗有效量的辛酸和癸酸甘油三酯是这样的,其中治疗有效量的辛酸和癸酸甘油三酯是0.1%、0.2%、0.3%、0.4%、0.5%、0.6%、0.7%、0.8%、0.9%、1%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%和70%。
在一个实施方案中,用于在治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症中使用的组合物是这样的组合物,其中所述治疗包括局部应用所述组合物,所述组合物包含:0.1重量%至70重量%的辛酸和癸酸甘油三酯和治疗有效量的如上所定义的褪黑素或其衍生物,特别地0.004重量%至12重量%的褪黑素或其衍生物;以及一种或多种可接受的赋形剂或载体。
术语“局部用组合物”是指适用于其“局部应用”的组合物。术语“局部应用”是指在皮肤、毛发、耳部、粘膜上的应用,直肠应用和鼻腔应用,以及在口腔内的牙齿或牙龈应用。
上面关于本发明第一方面公开的与由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症有关的全部实施方案也适用于本发明第二方面的组合物。
术语“适当的局部用可接受”是指适用于制备适用于被局部施加的组合物的赋形剂或载体。
本发明的局部用组合物可以以若干种形式配制,所述若干种形式包括但不限于溶液、气溶胶和非气溶胶喷雾剂、剃须膏、粉末、摩丝、洗剂、凝胶、棒状物、膏剂、糊剂、霜剂、洗发剂、淋浴凝胶、沐浴剂或洗面剂。
本发明的局部用组合物可以根据现有技术中熟知的方法制备。适当的赋形剂和/或载体及其量可以由本领域技术人员根据所制备的配制品的类型容易地确定。
在一个实施方案中,本发明的所述使用的局部用组合物是这样的局部用组合物,其中适当的局部用赋形剂或载体选自由以下组成的组:皮肤屏障恢复剂、吸水剂、润肤剂(emollient)、乳化剂、表面活性剂、增稠剂、湿润剂(humectant)、pH调节剂、抗氧化剂、防腐剂、媒介物、螯合剂、吸收剂及其混合物。
本文使用的术语“吸水剂”或“保湿剂(moisturizer)”或“保湿剂(moisturizingagent)”可互换用于指增加皮肤含水量并有助于保持其柔软和光滑的材料。适当的局部用吸水剂的实例包括但不限于聚二甲基硅氧烷醇、甘氨酸、透明质酸、透明质酸钠交联聚合物、甜菜碱、透明质酸二甲基硅烷醇酯、硬脂酸镁、麦芽糖醇、麦芽糖、吡咯烷酮羧酸(PCA)、PCA锰、PCA钠、甘露糖醇、海藻糖、三乳糖(trilactin)、葡萄糖、谷氨酸、水解刺云实(caesalpinia spinosa)胶、刺云实胶、碧桃(prunus persica)提取物、野黑樱(prunusserotina)提取物、狭叶松果菊(echinacea angustifolia)提取物、松果菊(Echinaceapurpurea)提取物、甲基葡糖醇聚醚、水解小麦蛋白、赤藓醇、硬脂酰谷氨酸铝、乙酰甲硫氨酸铜(copper acetylmethionate)或双十三烷基二聚体二亚油酸酯(ditridecyl dimmerdilinoleate)。本发明组合物中吸水剂的量可以为0,01%至20%。
术语“皮肤屏障恢复剂”是指其组成和/或结构类似于皮肤屏障,使得修复其缺陷的材料。适当的局部用皮肤屏障修复剂的实例包括但不限于神经酰胺类、胆固醇、脂肪酸类和这些脂质的前体(包括脑苷脂类、鞘氨基醇基质(sphingoid base)(诸如植物鞘氨醇(phytosphingosine)或鞘氨醇(sphingosine)))、或磷脂类(包括磷脂酰胆碱)和促进表皮脂质的合成的剂(如烟酰胺、脲、右泛醇和α-羟基酸包括乳酸)等。本发明组合物中皮肤屏障恢复剂的量可以为0.1%至20%。
术语“润肤剂(emollient)”剂是指使皮肤软化和平滑以校正皮肤干燥和脱屑,从而使皮肤表面润滑、促进皮肤水分保持和改变产品纹理的材料。术语“润肤剂”包括亲水性润肤剂和亲脂性润肤剂。术语“亲水性润肤剂”是指可溶于水中的润肤剂,诸如甘油、山梨糖醇和丙二醇。术语“亲脂性润肤剂”包括不可溶于水的。适当的局部用润肤剂的实例包括但不限于羟基硬脂酸辛酯、羊毛脂、辛酸/癸酸甘油三酯、棕榈酸鲸蜡酯、辛基十二烷醇、鲸蜡醇、异硬脂酸异丙酯、双月桂酸甘油酯、肉豆蔻酸异丙酯、棕榈醇、聚二甲基硅氧烷、角鲨烷、星油藤(plukenetia volubilis)种子油、牛油树果(butyrospermum parkii)黄油、椰油酸蔗糖酯或其混合物。本发明组合物中润肤剂的量可以为0.1%至35%。
术语“湿润剂”剂是指通过吸收或吸附从周围环境中吸引水分子,从而防止皮肤失去水分的吸湿性材料。适当的局部用湿润剂的实例包括但不限于甘油、二甘油、乙基己基甘油、葡萄糖、蜂蜜、乳酸、聚乙二醇、丙二醇、山梨糖醇、蔗糖或海藻糖(threalose)。本发明组合物中湿润剂的量可以为0.1%至10%。
本文使用的术语“增稠剂(thickening agent)”或“增稠剂(thickener)”或“粘度剂”可互换地指增加其粘度而基本上不改变其其他特性的材料。适当的局部用增稠剂的实例包括但不限于纤维素或其衍生物,诸如羟丙基甲基纤维素,聚乙二醇,微晶纤维素,鲸蜡硬脂醇,藻酸盐,支链多糖,煅制二氧化硅,黄原胶,卡波姆和聚丙烯酸酯。本发明组合物中增稠剂的量可以为0.1%至3%。
本文使用的术语“乳化剂(emulsifying agent)”或“乳化剂(emulsifier)”可互换地指减小表面张力,从而通过改变界面张力促进不易混溶的液体的均质混合物形成的材料。乳化剂通过增加乳剂的动力学稳定性来稳定乳剂。
术语“表面活性剂”是指降低液体表面张力和两种液体之间的界面张力,使得其更易于扩散的材料。表面活性剂具有吸引水分子的亲水头和排斥水且同时使其自身连接至污物中的油脂的疏水尾。这些相反的力释放了污物并且使其混悬于水中,从而在表面活性剂溶解于水时具有将其从表面诸如人体皮肤、纺织品和其他固体上除去的能力。
优选地将使用的局部用组合物配制为乳剂。乳剂是包含至少两个不混溶的相的分散体系,一个相作为液滴分散在另一个相中。包括上述乳化剂以改善稳定性。当水是分散相并且油是分散介质时,乳剂被称作油包水型乳剂(w/o)。当油作为液滴分散于水相时,乳剂被称作水包油型乳剂(o/w)。本领域已知的其他类型的乳剂是多重乳剂,诸如水包油包水型乳剂(w/o/w);GELTRAP乳剂,其中内部水相胶凝化且其被油相覆盖;和SWOP乳剂,也称作反转乳剂。所用的乳剂优选地是水包油型乳剂。优选地,用于在本发明意义上使用的乳剂与霜剂和洗剂相容。
优选地将使用的另一种局部用组合物配制成“表面活性剂基质”。表面活性剂基质是至少两种表面活性剂的掺合物。表面活性剂通常用于清洁产品中,破坏染色剂和将污物保持在水溶液中以防止其重新沉积在表面上。表面活性剂分散通常不溶解于水的污物,从而将其可分散于水中并且可用洗涤水除去。包括上述的表面活性剂是为了降低表面张力。优选地,用于在本发明意义上使用的表面活性剂基质与洗发剂、沐浴凝胶和身体洗剂或洗面剂相容。
术语“抗氧化剂”是指减缓或防止其他分子氧化的材料。抗氧化剂包括自由基清除剂和还原剂。适当的抗氧化剂的实例包括但不限于自由基清除剂或还原剂,诸如乙酰半胱氨酸、抗坏血酸、抗坏血酸棕榈酸酯、丁基化羟基甲苯、绿茶提取物、咖啡酸、半胱氨酸、生育酚、泛醌、肌肽、没食子酸丙酯、丁基化羟基甲苯(BHT)及其混合物。本发明组合物中抗氧化剂的量可以为0.1%至20%。
术语“pH调节”剂是指可用于将成品的pH调整到所需水平而不影响溶液的稳定性的酸或碱。适当的局部pH调节剂的实例包括但不限于乙酸、乳酸、柠檬酸、乙醇胺、甲酸、草酸、氢氧化钾、氢氧化钠、三乙醇胺或其混合物。本发明组合物中pH调节剂的量可以为0.01%至3%。
术语“防腐剂”是指预防或减少或减缓微生物生长的材料,条件是不影响溶液的稳定性。适当的防腐剂的实例包括但不限于苯甲酸、对羟基苯甲酸丁酯、对羟基苯甲酸乙酯、对羟基苯甲酸丙酯、对羟基苯甲酸甲酯、山梨酸、山梨酸钾、苯甲酸钠、苯氧乙醇、三氯生或其混合物。本发明组合物中防腐剂的量可以为0.01%至1.5%。
术语“螯合剂”是指能够配位或结合金属离子诸如钙、镁、铁和锰金属离子的材料。本发明组合物中螯合剂的量可以为0.001%至0.1%。
术语“吸收剂”是指这样的材料,所述材料能够与对吸收剂具有亲和力的化合物相互作用并保留所述化合物的材料。术语吸收剂也可以是能够从周围大气中吸收水分或以其他方式除去水分的任何材料,或者能够从大气层中吸收或以其他方式除去其他化合物,诸如但不限于氧气、二氧化碳、一氧化碳和胺复合物的任何材料。在本文中,术语吸收剂可以与术语脱水剂、干燥剂或吸附剂互换使用。吸收剂的非限制性实例将包括硅胶、干燥剂粘土、分子筛、沸石或其组合。本发明组合物中吸收剂的量可以为0.1%至5%。
上述组合物还包括媒介物。媒介物的实例包括但不限于水、丙二醇、丁二醇、乙醇、异丙醇或硅氧烷。优选地,媒介物是水。
另外,本发明组合物可以含有其他成分,诸如芳香剂、香精、着色剂和现有技术中已知用于在局部用配制品中使用的其他组分。
在一个实施方案中,本发明的第二方面的所述使用的局部用组合物是这样的局部用组合物,其中所述组合物包含一种或多种另外的活性成分;特别地选自由以下组成的组的一种或多种另外的活性成分:***素、补骨脂酚、维生素或其衍生物、肽、α羟基酸、α氨基酸、防晒活性剂及其混合物。
在一个实施方案中,局部用组合物还包含作为另外的活性成分的一种或多种***素;其特别地选自由以下组成的组:棕榈酰乙醇酰胺和类似物及其衍生物。
在一个实施方案中,局部用组合物还包含作为另外的药物活性成分的一种或多种维生素或其衍生物;其特别地选自由以下组成的组:维生素c及其酯、B组维生素及其衍生物诸如维生素B3(烟酰胺)。在一个实施方案中,局部用组合物还包含占组合物的0.5重量%至30重量%的量的作为另外的药物活性成分的一种或多种维生素或其衍生物。
在一个实施方案中,局部用组合物还包含选自一种或多种维生素C酯,所述一种或多种维生素C酯选自由以下组成的组:抗坏血酸四异棕榈酸酯、抗坏血酸棕榈酸酯、抗坏血酸硬脂酸酯、抗坏血酸亚油酸酯及其混合物;特别是抗坏血酸四异棕榈酸酯。在一个实施方案中,局部用组合物还包含占组合物的1重量%至20重量%的量的如上所定义的一种或多种维生素C酯。
在一个实施方案中,局部用组合物还包含B组维生素。在一个实施方案中,局部用组合物还包含烟酰胺。在一个实施方案中,局部用组合物还包含占组合物的0.5重量%至6重量%的量的烟酰胺。出于本发明的目的,术语“烟酰胺(niacinamide)”,“烟酰胺(nicotinamide)”,“烟酸酰胺”,“吡啶-3-羧酸酰胺”、“维生素b3”和“维生素pp”具有相同的含义,并且可互换使用。它们是指具有CAS注册号98-92-0、具有下式的化合物的非专有名称:
在一个实施方案中,局部用组合物还包含补骨脂酚;特别地其量占组合物的0.1重量%至1重量%。出于本发明的目的,术语“补骨脂酚”是分离自补骨脂(P.corylifolia)的天然杂萜(meroterpene)的非专有名称,具有CAS注册号10309-37-2且具有下式:
在一个实施方案中,局部用组合物还包含作为另外的活性成分的一种或多种肽;其特别地选自由以下组成的组:肌肽、棕榈酰寡肽、棕榈酰四肽-7、十四烷基氨基丁酰缬氨酰氨基丁酸脲三氟乙酸酯以及其他信号肽、载体肽和神经递质肽。在一个实施方案中,局部用组合物还包含占组合物的1重量%至11重量%的量的作为另外的药物活性成分的一种或多种肽。
出于本发明的目的,术语“肌肽”和“L--肌肽”具有相同的含义,并且它们可互换使用。这些术语是具有下式的、具有CAS注册号305-84-0的β-丙氨酰-L-组氨酸的非专有名称:
在一个实施方案中,局部用组合物还包含肌肽;特别地其量占组合物的0.01重量%至5重量%。
在一个实施方案中,局部用组合物还包含作为另外的活性成分的一种或多种α羟基酸;其特别地选自由以下组成的组:乙醇酸、乳酸和柠檬酸。
在一个实施方案中,局部用组合物还包含作为另外的活性成分的一种或多种α氨基酸;其特别地选自由以下组成的组:甜菜碱,占组合物的1重量%和5重量%;特别地甜菜碱。出于本发明的目的,术语甜菜碱是具有CAS注册号107-43-7的且具有下式的2-三甲基铵基乙酸盐的非专有名称:
在一个实施方案中,局部用组合物还包含作为另外的药物活性成分的一种或多种防晒活性剂。如本文所用的术语“防晒活性剂”涉及这样的单一或组合的材料,所述材料基于其吸收、散射或反射紫外(UV)辐射的能力被视为作为活性防晒成分可接受的材料。此类化合物通常被描述为UVA、UVB或UVA/UVB活性剂。特别地,“防晒有机活性剂”是指这样的单一或组合的有机化合物,所述有机化合物基于其主要吸收紫外(UV)辐射的能力被视为作为活性防晒成分可接受的材料。此类化合物通常被描述为UVA、UVB或UVA/UVB活性剂。
在一个实施方案中,本发明的第二方面的所述使用的局部用组合物是包含以下的局部用组合物:
55重量%至70重量%的辛酸和癸酸甘油三酯;
0.004重量%至1重量%的如权利要求3中所定义的褪黑素或其衍生物;
0.1重量%至1重量%的补骨脂酚;以及
1重量%至20重量%的维生素c或其衍生物;
成分的总和是100重量%。
在一个实施方案中,本发明的第二方面的所述使用的局部用组合物是包含以下的局部用组合物:
55重量%至70重量%的辛酸和癸酸甘油三酯;
0.004重量%至1重量%的如本发明中所定义的褪黑素或其衍生物;
0.1重量%至1重量%的补骨脂酚;
1重量%至11重量%的维生素c或其衍生物;以及
20重量%至30重量%的润肤剂;
成分的总和是100重量%。
在一个实施方案中,本发明的第二方面的所述使用的局部用组合物是这样的局部用组合物,其中润肤剂选自由以下组成的组:新戊酸异癸酯、聚二甲基硅氧烷、氢化聚异丁烯、辛基十二烷醇及其混合物。
如上所述,本发明的第二方面是指用于在治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症中使用的药物局部用组合物,其中:所述治疗包括局部应用药物组合物,所述药物组合物包含0.1重量%至70重量%的治疗有效量的辛酸和癸酸甘油三酯,以及一种或多种药学上可接受的赋形剂或载体。本发明的第二方面的包含辛酸和癸酸甘油三酯的组合物促进丝聚蛋白和胶原蛋白的表达(产生)。此方面还可以明确地表达为如上所定义的局部用药物组合物用于制备用于预防和/或治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症的药物的用途,其中所述治疗包括局部应用本发明的药物组合物,所述药物组合物包含0.1重量%至70重量%的治疗有效量的辛酸和癸酸甘油三酯。其还涉及一种用于治疗罹患或易于罹患由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症的哺乳动物,其中所述方法包括向所述哺乳动物施用治疗有效量的本发明的局部用药物组合物。
在整个说明书和权利要求中,单词“包含”和所述单词的变型并不旨在排除其他技术特征、添加剂、组分或步骤。此外,单词“包含”涵盖“由……组成”的情况。本发明的其他目的、优点和特征对于本领域的技术人员来说,在检查说明书后将变得显而易见,或者可以通过本发明的实践来学习。通过例证的方式提供以下实施例,并且它们并不旨在限制本发明。此外,本发明涵盖本文所述的特定和优选实施方案的所有可能的组合。
实施例
1.本发明的组合物
1.1.实施例1-夜用乳剂
A.组合物
乳剂组成如下
在以上组合物中,辛酸和癸酸甘油三酯的量是2重量%,肌肽的量是0.5重量%,烟酰胺的量是3重量%,褪黑素的量是0.05重量%并且甜菜碱的量是1重量%。
B.制备过程
根据包括以下步骤的过程制备了具有下表所指示组成的晚霜:
B.1.相的制备
水相(%)(1):将来自相(1)的组分在搅拌下相继地添加在主容器中,直至具有均匀溶液。
油相(2):在辅助器皿中,添加来自相(2)的组分并且将其溶解。
相(3):在辅助器皿中,在搅拌下相继地添加来自相(3)的组分,直至具有均匀混合物。
B.2.用于制造乳剂的过程:
步骤1:将相(2)添加至相(1)并且然后混合所得混合物,直至具有乳剂;以及
步骤2:将相(3)添加至步骤1中获得的所得乳剂以获得最终乳剂。
1.2.实施例2
A.组合物
在以上组合物中,辛酸和癸酸甘油三酯的量是55重量%,褪黑素的量是0.05重量%,补骨脂酚的量是0.3重量%,并且维生素C衍生物的量是8重量%。
B.制备过程
在搅拌下逐一添加组分0至10,直至获得均匀混合物。
2.基质蛋白的测定
2.1.样品
-正常人真皮成纤维细胞生长补充剂购自PAN Biotech。
-包括杜氏改良型伊格尔培养基(Dulbecco’s modified Eagle’s medium)(DMEM,胎儿牛血清(FBS)和青霉素-链霉素)的细胞培养基获自Gibco BRL。
-正常人角质形成细胞生长补充剂购自CELLnTech。
用于测定成纤维细胞培养物中的胶原蛋白III:
-用500μl浓度为0.1%、0.2%、1%和2%(以g/100mL表示)的辛酸/癸酸甘油三酯处理的成纤维细胞。
-空白:成纤维细胞P8-9
用于测定角质形成细胞培养物中的丝聚蛋白:
-用500μl浓度为0.1%、0.2%、1%和2%(以g/100mL表示)的辛酸/癸酸甘油三酯处理的角质形成细胞。
-空白:角质形成细胞
在用于测定成纤维细胞培养物中的胶原蛋白III和角质形成细胞培养物中的丝聚蛋白的体外测定中使用的活性成分(例如辛酸和癸酸甘油三酯)的量等同于在将本发明的组合物局部应用在皮肤上之后到达成纤维细胞和角质形成细胞的活性成分的量。
2.2.设备
Nikon Ti-S显微镜(metamorph)。
Incucyte(ESSEN BioScience)。
2.3.抗体
-纯化的冷冻干燥的针对人III型胶原蛋白的抗体;参考:20311(novotec)
-抗丝聚蛋白抗体;参考:PAJ103hu01(cloud-cloud)
2.4.方法
-正常人真皮成纤维细胞生长补充剂购自PAN Biotech。
-包括杜氏改良型伊格尔培养基(DMEM,胎儿牛血清(FBS)和青霉素-链霉素)的细胞培养基获自Gibco BRL。
-正常人角质形成细胞生长补充剂购自CELLnTech。
2.5.细胞培养
成纤维细胞
-培养:从在妇女整容手术(45岁)时移取的人真皮面部组织中分离原代人真皮面部成纤维细胞(HDF)并且在第2-15次传代时使用。将HDF维持在含有10%FBS和1%青霉素-链霉素的DMEM中。
-人成纤维细胞:40岁患者的面部表皮成纤维细胞。
角质形成细胞
-培养:从人表皮组织中分离的原代人表皮成人角质形成细胞(HEK)购自CELLnTecadvanced cell systems。将HEK维持在补充有Cnt-57-S(CELLnTEC)的CnT-基础培养基中。将细胞维持在5%CO2和37℃下的加湿室中。培养基每4天更换一次。
-人角质形成细胞:表皮角质形成细胞祖细胞,合并的:(HPEKp;CellnTec)。
2.6.免疫染色
对于免疫染色,将孔中的培养物细胞用PBS洗涤并且用4%多聚甲醛固定10min,在用PBS洗涤后,用在PBS中的0.2%Triton-X100透化固定细胞10min。在用PBS进行两次洗涤后,将细胞在37℃下用在PBS中的1%BSA+0.1%吐温20封闭60min。将细胞与一抗在37℃下在封闭缓冲液中一起孵育过夜。洗涤后,应用以下二抗:Alexa Fluor 488山羊抗小鼠免疫球蛋白G(IgG)(Molecular Probes)和Alexa Fluor 488山羊抗兔IgG(Molecular Probes)。将细胞与二抗在室温下在封闭缓冲液中一起孵育2小时。用PBS洗涤后,将细胞与DAPI在室温中一起孵育10min。使用具有带式过滤器(DAPI/GFP)的Nikon Ti-S显微镜获得荧光图像。
2.7.成纤维细胞培养物中的胶原蛋白III的测定
下表显示通过使用CCT增加了成纤维细胞中胶原III的产生。表达的胶原III的量随CCT的渐增浓度增加1.1、1.8、2.3和2.5倍,如下表中所述,其中CCT的量表示为CCT克/100mL:
CCT(%) | 成纤维细胞中胶原蛋白III的表达 |
0(空白) | 57558,6 |
0.1 | 62627,1 |
0.20 | 102986,8 |
1 | 130587,6 |
2 | 141063,6 |
如以上结果中所示,CCT使得增加成纤维细胞中胶原蛋白、特别是胶原蛋白III的产生。这是有利的,这是因为CCT可用于改善或治疗通过由胶原蛋白产生的减少引起的胶原蛋白缺乏或通过胶原蛋白变性的增加介导的疾病或病症。
2.8.角质形成细胞培养物中的丝聚蛋白的测定
下表显示通过使用CCT增加了成纤维细胞中丝聚蛋白的产生。表达的丝聚蛋白的量随CCT的渐增浓度增加1.7和2.8倍,如下表中所述,并且CCT的量表示为CCT克/100mL:
CCT(%) | 角质形成细胞中丝聚蛋白的表达 |
0(空白) | 38795,3 |
1.00 | 65175,8 |
10 | 108008,1 |
如以上结果中所示,CCT使得增加成纤维细胞中丝聚蛋白的产生。这是有利的,这是因为由于丝聚蛋白在维持抵抗环境条件的有效皮肤屏障方面发挥关键作用,因此CCT可用作用于增强/修复皮肤的功能和健康的皮肤恢复剂。特别地,CCT可用于改善或治疗通过由丝聚蛋白产生的减少引起的丝聚蛋白缺乏或通过丝聚蛋白变性的增加介导的疾病或病症。
Claims (15)
1.用于在治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症中使用的辛酸和癸酸甘油三酯,其中所述治疗包括局部应用治疗有效量的辛酸和癸酸甘油三酯。
2.根据权利要求1中任一项所述使用的辛酸和癸酸甘油三酯,其中所述疾病或病症由丝聚蛋白缺乏介导,选自由银屑病、特应性皮炎和寻常型鱼鳞癣组成的组;或者可替代地由胶原蛋白缺乏介导,选自由皮肤老化和皮肤光老化组成的组。
4.一种用于在治疗由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症中使用的局部用组合物,其中所述治疗包括局部应用所述组合物,所述组合物包含占所述组合物的总重量的0.1重量%至70重量%的有效量的辛酸和癸酸甘油三酯,以及一种或多种适当的局部用可接受的赋形剂或载体。
5.根据权利要求4所述使用的局部用组合物,其中所述局部用组合物是药物局部用组合物,并且所述治疗包括局部应用所述药物局部用组合物,所述药物局部用组合物包含:0.1重量%至70重量%的治疗有效量的辛酸和癸酸甘油三酯和0.004重量%至12重量%的治疗有效量的如权利要求3中所定义的褪黑素或其衍生物;以及一种或多种可接受的赋形剂或载体。
6.根据权利要求4或5中任一项所述使用的局部用组合物,其中所述由丝聚蛋白或胶原蛋白缺乏介导的疾病或病症选自由以下组成的组:银屑病、局部皮炎、寻常型鱼鳞癣、皮肤老化和皮肤光老化。
7.根据权利要求4-6中任一项所述使用的局部用组合物,其中所述适当的局部用赋形剂或载体选自由以下组成的组:吸水剂、润肤剂、乳化剂、表面活性剂、增稠剂、湿润剂、pH调节剂、抗氧化剂、防腐剂、媒介物、螯合剂、吸收剂及其混合物。
8.根据权利要求4-7中任一项所述使用的局部用组合物,其中所述组合物包含一种或多种另外的活性成分。
9.根据权利要求8所述使用的局部用组合物,其中所述另外的活性成分选自由以下组成的组:***素、补骨脂酚、维生素或其衍生物、肽、α羟基酸、α氨基酸、防晒活性剂及其混合物。
10.根据权利要求4-9中任一项所述使用的局部用组合物,其中所述治疗包括局部应用所述组合物,所述组合物包含占所述组合物的总重量的55重量%至70重量%的有效量的辛酸和癸酸甘油三酯,以及一种或多种适当的局部用可接受的赋形剂或载体。
11.根据权利要求10所述使用的局部用组合物,其中所述组合物包含:
55重量%至70重量%的辛酸和癸酸甘油三酯;
0.004重量%至1重量%的如权利要求3中所定义的褪黑素或其衍生物;
0.1重量%至1重量%的补骨脂酚;以及
1重量%至20重量%的维生素C或其衍生物;
成分的总和是100重量%。
12.根据权利要求11所述使用的局部用组合物,其中所述组合物还包含20重量%至30重量%的润肤剂。
13.根据权利要求11-12中任一项所述使用的局部用组合物,其中所述维生素C的所述衍生物是抗坏血酸四异棕榈酸酯。
14.根据权利要求4-9中任一项所述使用的组合物,其中所述治疗包括局部应用所述组合物,所述组合物包含占所述组合物的总重量的1重量%至10重量%的有效量的辛酸和癸酸甘油三酯,以及一种或多种适当的局部用可接受的赋形剂或载体。
15.根据权利要求14所述使用的局部用组合物,其中所述组合物包含:
1重量%至10重量%的辛酸和癸酸甘油三酯;
0.004重量%至1重量%的如权利要求3中所定义的褪黑素或其衍生物;
0.05重量%至1重量%的肌肽;
0.5重量%至6重量%的烟酰胺;
0.5重量%至5重量%的甜菜碱;并且
成分的总和是100重量%。
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MX2021009602A (es) | 2021-09-08 |
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