CN111315387A - 用于预防或治疗毛发脱落或者促进毛发生长的药物组合物或化妆品组合物 - Google Patents

用于预防或治疗毛发脱落或者促进毛发生长的药物组合物或化妆品组合物 Download PDF

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CN111315387A
CN111315387A CN201880072894.1A CN201880072894A CN111315387A CN 111315387 A CN111315387 A CN 111315387A CN 201880072894 A CN201880072894 A CN 201880072894A CN 111315387 A CN111315387 A CN 111315387A
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hair
growth factor
weight
pharmaceutical composition
composition
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梁美京
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Abstract

本发明涉及用于预防或治疗毛发脱落或者促进毛发生长的药物组合物或化妆品组合物。根据本发明的组合物显示出优异的预防或治疗毛发脱落和促进毛发生长的效果，并且不论性别和年龄均可安全使用。

Description

用于预防或治疗毛发脱落或者促进毛发生长的药物组合物或 化妆品组合物
技术领域
本发明涉及用于预防或治疗毛发脱落或者促进毛发生长的药物组合物或化妆品组合物。更特别地，本发明涉及用于预防或治疗毛发脱落或者促进毛发生长的包含烟酸腺嘌呤二核苷酸磷酸(nicotinic acid adenine dinucleotide phosphate，NAADP)和选自包含以下的组的至少一种的药物组合物或化妆品组合物：一种或更多种天然来源的氨基酸或其盐、一种或更多种生长因子、头蛋白(noggin)、一种或更多种饱和或不饱和的C8至C18长链脂肪酸或其盐、一种或更多种活性因子和一种或更多种水溶性维生素或其盐。
背景技术
已知毛发脱落是由局部感染、内分泌失调、遗传因素和自身免疫以及已知的遗传原因引起的。近来，毛发脱落不仅出现在中年和老年男性中而且也出现在女性或更年轻一代中。因此，随着对这样的毛发脱落的预防和治疗的需求提高，已对具有多种效力的物质进行了研究来克服毛发脱落。
目前用于预防或治疗毛发脱落和促进毛发生长的药物包括血管扩张剂，其用于使足够的血在头皮中循环；抑制将睾酮转化为5-DHT(5-二氢睾酮)的5α-还原酶活性的活性抑制剂等。血管扩张剂的一些实例包括米诺地尔(minoxidil)等，并且5-DHT活性抑制剂的一些实例包括非那雄胺(finasteride)、度他雄胺(dutasteride)等。在另一方面中，除如上所述的有机合成材料之外还使用天然衍生物(例如多种植物提取物)，但其机制和效果未被清楚地揭示。
然而，由于目前使用的用于预防和治疗毛发脱落和促进毛发生长的制剂在其效果方面不充分或具有多种问题(例如副作用)，因此需要开发更有效和安全的用于预防或治疗毛发脱落或者用于促进毛发生长的制剂。
发明内容
技术问题
本发明的目的是提供在预防或治疗毛发脱落或者促进毛发生长方面具有优异效果并且不论年龄和性别均可适用的安全的药物组合物和安全的化妆品组合物。
解决方案
为了实现上述目的，本发明提供了用于预防或治疗毛发脱落或者促进毛发生长的药物组合物和化妆品组合物，其包含具有由以下式(I)表示的结构的化合物或其盐，以及选自包含以下的组的至少一种：一种或更多种天然来源的氨基酸或其盐、一种或更多种生长因子、头蛋白、一种或更多种饱和或不饱和的C8至C18长链脂肪酸或其盐、一种或更多种活性因子和一种或更多种水溶性维生素或其盐：
Figure BDA0002485967820000021
其中：
R1和R2各自独立地是H、未经取代或被卤素取代的C1-4烷基，或-CH2-CO-CH3；
W选自NH2、OH和SH；
X选自H、OH、SH、NH2和卤素；以及
Y选自OH、H、NH2和卤素。
发明的有益效果
根据本发明的组合物显示出优异的预防或治疗毛发脱落和促进毛发生长的效果，并且不论性别和年龄均可安全地使用。
附图说明
图1是示出根据实验例1的在人毛真皮乳头细胞中细胞毒性测试结果的图。
图2是示出根据实验例2的促进人毛真皮乳头细胞增殖的测试结果的图。
图3是示出根据实验例3的在毛真皮乳头细胞中毛根产生率的测试结果的图。
图4是示出根据实验例4的毛发密度的测试结果的图。
图5是示出根据实验例5的毛发伸长率的测量结果的图。
具体实施方式
下面详细描述本发明。
本发明涉及用于预防或治疗毛发脱落或者促进毛发生长的药物组合物和用于预防或改善毛发脱落或促进毛发生长的化妆品组合物，其包含：具有由以下式(I)表示的结构的化合物或其盐；以及选自包含以下的组的至少一种：一种或更多种天然来源的氨基酸或其盐、一种或更多种生长因子、头蛋白、一种或更多种饱和或不饱和的C8至C18长链脂肪酸或其盐、一种或更多种活性因子和一种或更多种水溶性维生素或其盐：
Figure BDA0002485967820000031
其中：
R1和R2各自独立地是H、未经取代或被卤素取代的C1-4烷基，或-CH2-CO-CH3；
W选自NH2、OH和SH；
X选自H、OH、SH、NH2和卤素；以及
Y选自OH、H、NH2和卤素。
在本发明的一个实施方案中，式(I)化合物可以是烟酸腺嘌呤二核苷酸磷酸(NAADP)或者其盐或衍生物。在本发明中使用的NAADP是通过CD38，即细胞中的ADP-核糖基环化酶合成的一种(Chini EN.et al.，Biochem J 362：125-130，2002；BERRIDGE G.etal.，Biochem.J.，365：295-301，2002；Aarhus R.et al.，J Biol Chem.，270(51)：30327-30333，1995)。
此外，本发明中使用的具有式(I)的结构的化合物可作为游离物质以及其可药用盐、溶剂合物、多晶型物或前药提供。另外，具有式(I)的结构的化合物的盐不特别地受限制，只要其是以可在药物或化妆品中复合的形式即可，并且其可包含无机盐或有机盐并且可以是酸性盐或碱性盐。特别地，当盐由阳离子形成时，其可以是碱金属盐，例如钠盐或钾盐；碱土金属盐，例如钙盐、镁盐或钡盐；碱性氨基酸盐，例如精氨酸和赖氨酸；铵盐，例如铵盐或三环己基铵盐；以及多种链烷醇胺盐，例如单乙醇胺盐、二乙醇胺盐、三乙醇胺盐、单异丙醇胺盐、二异丙醇胺盐和三异丙醇胺盐等。优选地，盐是碱金属盐，并且更优选地，可以是四钠盐。
在本发明的一个实施方案中，氨基酸可选自包含以下的组：丙氨酸、精氨酸、天冬酰胺、天冬氨酸、半胱氨酸、谷氨酸、谷氨酰胺、甘氨酸、组氨酸、异亮氨酸、亮氨酸、赖氨酸、甲硫氨酸、苯丙氨酸、脯氨酸、丝氨酸、苏氨酸、色氨酸、酪氨酸和缬氨酸，并且氨基酸的盐不受限制，只要其是可药用盐即可。
本文中使用的术语“生长因子”是指具有促进人体中多种细胞的分裂、生长和分化的功能的多肽，并且包含通过基因重组或提取获得的那些。
在本发明的一个实施方案中，生长因子可选自包含以下的组：上皮生长因子(epithelial growth factor，EGF)、酸性成纤维细胞生长因子(acidic fibroblastgrowth factor，FGF(a))、碱性成纤维细胞生长因子(basic fibroblast growth factor，FGF(b))、血管内皮生长因子(vascular endothelial growth factor，VEGF)、血小板源性生长因子(platelet-derived growth factor，PDGF)和角质细胞生长因子(keratinocytegrowth factor，KGF)。
本文中使用的术语“头蛋白”是指参与人组织中神经组织、肌肉和骨的发育的蛋白质。
在本发明的一个实施方案中，头蛋白可通过本领域中已知的方法获得。
在本发明的一个实施方案中，尽管长链脂肪酸不受特别地限制只要其是饱和或不饱和的C8至C18长链脂肪酸即可，但长链脂肪酸可选自包含以下的组：亚麻酸、豆蔻酸、油酸和棕榈酸，并且长链脂肪酸的盐不受特别地限制，只要其是可药用的即可。
在本发明的一个实施方案中，活性因子可选自包含以下的组：肌醇、腺嘌呤、谷胱甘肽和胆固醇。
在本发明的一个实施方案中，水溶性维生素可选自包含以下的组：硫胺素(B1)、核黄素(B2)、烟酰胺(B3)、泛酸(B5)、吡哆醇(B6)、生物素(B7)、叶酸(B9)、氰钴胺素(B12)和抗坏血酸(C)，并且水溶性维生素的盐不受特别地限制，只要其是可药用的即可。
在本发明的一个实施方案中，药物组合物或化妆品组合物促进了毛真皮乳头细胞的增殖、延长了毛真皮乳头细胞的寿命、产生了毛真皮乳头细胞的毛根并且提高了毛发的密度、粗度或长度，或其组合，从而产生预防或治疗毛发脱落、促进毛发生长和预防或改善毛发脱落的效果，其通过本文中所公开的实验例证明。
在本发明的一个实施方案中，药物组合物或化妆品组合物可包含具有以上式(I)的结构的化合物或其盐、一种或更多种天然来源的氨基酸或其盐、包含一种或更多种生长因子和头蛋白的混合物、一种或更多种饱和或不饱和的C8至C18长链脂肪酸或其盐、一种或更多种选自包含肌醇、腺嘌呤、谷胱甘肽和胆固醇的组的活性因子和一种或更多种水溶性维生素或其盐。
在本发明的一个实施方案中，药物组合物或化妆品组合物可包含基于组合物的总重量的0.001重量％至1重量％的量的具有以上式(I)的结构的化合物或其盐。
在本发明的一个实施方案中，药物组合物或化妆品组合物可包含基于组合物总重量的0.001重量％至20重量％的量的氨基酸或其盐，并且该量可根据制剂和生产条件适当地调整。
在本发明的一个实施方案中，药物组合物或化妆品组合物可包含混合物，所述混合物包含基于组合物的总重量的0.001重量％至5重量％，优选0.5重量％至4重量％的量的生长因子和头蛋白。
在本发明的一个实施方案中，药物组合物或化妆品组合物可包含基于组合物的总重量的0.001重量％至5重量％，优选0.2重量％至1重量％的量的长链脂肪酸或其盐。
在本发明的一个实施方案中，药物组合物或化妆品组合物可包含基于组合物总重量的0.001重量％至5重量％，优选0.1重量％至0.5重量％的量的活性因子。
在本发明的一个实施方案中，药物组合物或化妆品组合物可包含基于组合物的总重量的0.001重量％至5重量％，优选0.2重量％至1.2重量％的量的水溶性维生素或其盐。
在本发明的一个实施方案中，药物组合物或化妆品组合物可包含基于100重量份的生长因子和头蛋白的4000重量份至40000重量份，优选16000重量份至40000重量份的量的氨基酸，
基于100重量份的生长因子和头蛋白的240重量份至4000重量份，优选1000重量份至4000重量份的量的水溶性维生素或其盐，
基于100重量份的生长因子和头蛋白的80重量份至1600重量份，优选160重量份至800重量份的量的活性因子，
基于100重量份的生长因子和头蛋白的200重量份至3200重量份，优选400重量份至1600重量份的量的长链脂肪酸或其盐，以及
基于100重量份的活性因子的6.25重量份至125重量份，优选12.5重量份至50重量份的量的生长因子和头蛋白。
在本发明的一个实施方案中，生长因子包含上皮生长因子(EGF)、酸性成纤维细胞生长因子(FGF(a))、碱性成纤维细胞生长因子(FGF(b))、血管内皮生长因子(VEGF)、血小板源性生长因子(PDGF)和角质细胞生长因子(KGF)。此外，所述药物组合物或化妆品组合物中上皮生长因子(EGF)∶酸性成纤维细胞生长因子(FGF(a))∶碱性成纤维细胞生长因子(FGF(b))∶血管内皮生长因子(VEGF)∶血小板源性生长因子(PDGF)∶角质细胞生长因子(KGF)∶头蛋白的重量比可以是0.1至10∶0.1至10∶0.1至10∶0.1至10∶0.1至10∶0.1至10∶0.1至10，优选2至6∶4至8∶4至8∶1至2∶1至2∶1至2∶1至2，并且更优选2至4∶2至6∶2至6∶2至6∶2至6∶2至6∶2至6。
在本发明的一个实施方案中，药物组合物或化妆品组合物中氨基酸或其盐∶长链脂肪酸或其盐∶活性因子∶水溶性维生素或其盐的重量比可以是100至2000∶10至200∶5至200∶10至200。
在本发明的一个实施方案中，组合物还可包含在药物组合物或化妆品组合物的制造中常规使用的合适的载体、赋形剂和稀释剂。
特别地，使用通常使用的赋形剂或稀释剂例如可药用填充剂、增量剂、黏合剂、润湿剂、崩解剂、表面活性剂等来配制组合物。另外，可添加抗凝剂、润滑剂、芳香剂、乳化剂、防腐剂等，并且可使用本领域中公知的方法配制组合物，以在向哺乳动物施用之后提供活性成分的迅速、持续或延迟释放。
根据本发明的药物组合物可被配制成本领域中已知的常规药物制剂，并且优选地可将其配制成经皮制剂和用于表面应用的皮肤外用制剂。
在本发明的一个实施方案中，根据本发明的药物组合物可以是皮肤外用制剂，并且可被配制成适用于皮肤(特别是是头皮)的任何可能的制剂，例如软膏剂、糊剂、凝胶剂、胶冻剂、浆液剂(serum)、气雾喷雾剂、非气雾喷雾剂、泡沫剂、乳膏剂、洗剂、溶液剂或混悬剂。
根据本发明的组合物可通过每天一次或两次表面应用到期望预防或治疗毛发脱落或者促进毛发生长的部位来施用。组合物的每日应用量为基于1重量％的活性成分的约0.5至3mg/cm2(皮肤表面积)，并且可根据应用部位的面积而提高或降低。施用的剂量和频率可根据患者的年龄、性别和毛发脱落进展的程度适当地提高或降低。
在另一方面中，根据本发明的化妆品组合物可以以任何可能的制剂应用于皮肤(特别是头皮)。更特别地，组合物可以以如下制剂制备：例如生发液、毛发调理剂、毛发精华、毛发洗剂、毛发营养洗剂、洗发香波、毛发护发素、毛发处理剂、发乳、毛发营养乳、毛发保湿乳、毛发按摩乳、发蜡、毛发气雾剂、发膜、营养发膜、洗发皂、毛发清洁泡沫、发油、毛发干燥剂、护发剂、染发剂、烫发剂、毛发漂白剂、发胶、发釉、美发剂、毛发定型剂、毛发保湿剂、毛发摩丝或毛发喷雾剂。另外，还可将其制备为与皮肤接触的皮肤接触型物质，例如化妆品、洗涤剂和纤维。
在本发明的一个实施方案中，本领域技术人员可在不损害本发明的目的和效果的范围内适当地选择和混合化妆品组合物的组分。可添加的复合成分的一些实例包括油和脂肪组分、保湿剂、润肤剂、表面活性剂、有机和无机色素、有机粉末剂、紫外线吸收剂、防腐剂、杀菌剂、抗氧化剂、植物提取物、pH调节剂、醇、染料、芳香剂、血液循环促进剂、皮肤凉爽剂、脱水剂、纯净水等。
发明实施方式
在下文中，将通过实施例的方式更详细地描述本发明。对于本领域技术人员而言将明显的是以下实施例仅是举例说明性的并且可在不脱离本发明的精神和范围的情况下进行多种改变和修改，并且这样的改变和修改也在所附权利要求的范围内。
实施例
制备例1.包含生长因子和头蛋白的混合物的制备
将上皮生长因子(EGF)、酸性成纤维细胞生长因子(FGF(a))、碱性成纤维细胞生长因子(FGF(b))、血管内皮生长因子(VEGF)、血小板源性生长因子(PDGF)、角质细胞生长因子(KGF)和头蛋白以下表1中所示的组成进行混合，并随后使用高速匀化器制备成脂质体(制备例(1-1)至(1-5))。通过用来源于人的基因转化大肠杆菌(E.coli)来合成生长因子和头蛋白，并通过SDS-PAGE和HPLC测量其含量。根据韩国食品和药物安全部(Korean Ministryof Food and Drug Safety)和美国PCPC(Personal care products council，个人护理产品协会)的INCI[International nomenclature cosmetic ingredient，国际化妆品成分命名]的针对化妆品和药物中使用的标准制备生长因子和蛋白质。
[表1]
(单位：mg) EGF FGF(a) FGF(b) VEGF PDGF KGF 头蛋白
制备例(1-1) 1 1.5 1.5 0.25 0.25 0.25 0.25
制备例(1-2) 0.5 1 1 0.5 0.5 0.5 0.5
制备例(1-3) 1 0.5 0.5 0.25 0.25 1 1
制备例(1-4) 0.5 1 1 0.5 0.5 0.25 0.25
制备例(1-5) 1 0.5 0.5 0.25 0.25 0.5 0.5
制备例2.营养物混合物的制备
以下表2中所示的组成将氨基酸、长链脂肪酸、活性因子和水溶性维生素进行混合，并随后使用高速匀化器制备成脂质体。(制备例(2-1)至(2-5))。根据韩国食品和药物安全部的针对化妆品或药物中使用的标准制备氨基酸、长链脂肪酸、活性因子和水溶性维生素。在氨基酸的情况下，基于重量将来源于天然的20种氨基酸均匀地混合，并且维生素、活性因子和脂肪酸也基于重量均匀地混合。每种组分的标准误差小于10％。
[表2]
Figure BDA0002485967820000091
Figure BDA0002485967820000101
比较制备例1.NAADP脂质体溶液
根据“Acidic residues at the active sites of CD38 and ADP-ribosylcyclase determine nicotinic acid adenine dinucleotide phosphate(NAADP)synthesis and hydrolysis activities”.The Journal of Biological Chemistry.281(39)：28951-7中所述的方法，使用购自Sigma-Aldrich(USA)的NADP(烟酰胺腺嘌呤二核苷酸磷酸(nicotinamide adenine dinucleotide phosphate))、烟酸(nicotinic acid，NA)和ADP-核糖基环化酶来制备NAADP。
使用通过将磷脂、卵磷脂、油酸和辛乙二醇以1∶1∶0.05∶0.05的比混合而制备的介质以及高速匀化器将所制备的NAADP制备成脂质体。
实施例1至9.混合物的制备
通过已知方法以下表3所示的组成制备混合物(包括制备例1的混合物和制备例2的混合物)。特别地，将制备例1的混合物以表1中所示的重量添加至1L纯净水，并且将制备例2的混合物以上表2中所示重量的两倍添加至其中。
[表3]
Figure BDA0002485967820000111
实施例10.混合物的制备
除将制备例(1-1)的量改变为0.25倍之外，以与实施例1中相同的方式制备混合物。
实施例11.混合物的制备
除将制备例(1-1)的量改变为0.5倍之外，以与实施例1中相同的方式制备混合物。
实施例12.混合物的制备
除将制备例(1-1)的量改变为2倍之外，以与实施例1中相同的方式制备混合物。
实施例13.混合物的制备
除将制备例(1-1)的量改变为5倍之外，以与实施例1中相同的方式制备混合物。
实施例14.混合物的制备
除将氨基酸的添加量改变为200mg之外，以与实施例1中相同的方式制备混合物。
实施例15.混合物的制备
除将氨基酸的添加量改变为400mg之外，以与实施例1中相同的方式制备混合物。
实施例16.混合物的制备
除将氨基酸的添加量改变为1600mg之外，以与实施例1中相同的方式制备混合物。
实施例17.混合物的制备
除将氨基酸的添加量改变为2000mg之外，以与实施例1中相同的方式制备混合物。
实施例18.混合物的制备
除将包含生物素的水溶性维生素的添加量改变为12mg之外，以与实施例1中相同的方式制备混合物。
实施例19.混合物的制备
除将包含生物素的水溶性维生素的添加量改变为24mg之外，以与实施例1中相同的方式制备混合物。
实施例20.混合物的制备
除将包含生物素的水溶性维生素的添加量改变为100mg之外，以与实施例1中相同的方式制备混合物。
实施例21.混合物的制备
除将包含生物素的水溶性维生素的添加量改变为200mg之外，以与实施例1中相同的方式制备混合物。
实施例22.混合物的制备
除将活性因子的添加量改变为4mg之外，以与实施例1中相同的方式制备混合物。
实施例23.混合物的制备
除将活性因子的添加量改变为8mg之外，以与实施例1中相同的方式制备混合物。
实施例24.混合物的制备
除将活性因子的添加量改变为40mg之外，以与实施例1中相同的方式制备混合物。
实施例25.混合物的制备
除将活性因子的添加量改变为80mg之外，以与实施例1中相同的方式制备混合物。
实施例26.混合物的制备
除将长链脂肪酸的添加量改变为10mg之外，以与实施例1中相同的方式制备混合物。
实施例27.混合物的制备
除将长链脂肪酸的添加量改变为20mg之外，以与实施例1中相同的方式制备混合物。
实施例28.混合物的制备
除将长链脂肪酸的添加量改变为80mg之外，以与实施例1中相同的方式制备混合物。
实施例29.混合物的制备
除将长链脂肪酸的添加量改变为160mg之外，以与实施例1中相同的方式制备混合物。
配方实施例
根据比较配方实施例1和2以及配方实施例1和2的组合物用根据以下表4的组合物来制备。然而，以下配方实施例旨在举例说明而不是限制本发明。
[表4]
Figure BDA0002485967820000151
实验例
实验例1.人毛真皮乳头细胞中的细胞毒性测试
为了证实人毛真皮乳头细胞(human hair dermal papilla cell，HHDPC)中的细胞毒性，进行了MTT测定，该测定通过测量通过脱氢酶作用的线粒体还原能力来确定细胞毒性。
将人毛真皮乳头细胞在HDP试剂盒培养基(人毛真皮乳头细胞培养基试剂盒)中在37℃下在5％CO2的培养箱(由Thermo Fisher Scientific，USA制造)中培养。
将培养的细胞以3×104个细胞/孔的浓度分配到24孔板中。18小时之后，向每个孔分别添加浓度为50μg/ml、100μg/ml和200μg/ml的根据制备例(1-1)至(1-5)的混合物和根据制备例(2-1)至(2-5)的混合物。然后，在37℃下将细胞在5％CO2培养箱中培养48小时。孵育48小时之后，每个孔用PBS(磷酸盐缓冲盐水)溶液洗涤一次，并添加有50μl 5mg/mL MTT试剂(Sigma，USA)和450μl新鲜培养基。将孔孵育2.5小时并随后除去上清液。当在每个孔中观察到甲臜晶体时，添加DMSO(二甲基亚砜)并在黑暗中摇动30分钟以溶解甲臜晶体，并随后使用分光光度计在750nm处测量吸光度。
测量结果示于表5和图1中，并且证实了不论处理浓度如何均没有观察到毒性。
[表5]
50μg/ml 100μg/ml 200μg/ml
制备例1-1 98 97 95
制备例1-2 99 96 95
制备例1-3 100 97 97
制备例1-4 100 98 96
制备例1-5 100 99 95
制备例2-1 100 99 98
制备例2-2 100 100 98
制备例2-3 100 100 95
制备例2-4 100 100 99
制备例2-5 100 100 95
实验例2.人毛真皮乳头细胞中细胞增殖效力的比较
为了比较细胞增殖效力，以与实验例1中相同的方式测试100μg/ml的根据实施例1至9的每种混合物和根据比较制备例1的1μM NAADP溶液。结果示于下表6和图2中。
在根据实施例1至9的混合物的处理下的细胞生长速率比在根据比较制备例1的NAADP溶液的处理下更好，并且证实了差异性提高的细胞增殖。特别地，包括根据制备例(1-1)的混合物的实施例1、4和5显示出更优异的细胞增殖效力。
[表6]
生长速率(％)
比较制备例1 20
实施例1 55
实施例2 47
实施例3 41
实施例4 51
实施例5 54
实施例6 45
实施例7 46
实施例8 41
实施例9 39
实验例3.人毛真皮乳头细胞中毛根产生率的测试
在人毛真皮乳头细胞中测量了毛发产生所需毛根的产生率。通过实验例1中所述的方法培养毛真皮乳头细胞并随后进行测试。用根据实施例1、4和5的混合物和根据比较制备例1的NAADP溶液以50μg/ml、100μg/ml和200μg/ml的浓度分别处理培养的毛真皮乳头细胞，并用显微镜测量毛根的数量。结果示于下表7和图3中。在用根据实施例1、4和5的混合物处理的组中，毛根的产量高于用比较实施例1的NAADP溶液处理的组。
[表7]
Figure BDA0002485967820000171
实验例4.人体内毛发密度的测试
根据由韩国食品和药物安全部提供的指南进行了将本发明的组合物应用于人体的测试。该测试进行了24周，并选择年龄为18至54岁的被诊断为患有雄激素性脱发的男性和女性作为测试对象。将二十名对象分别指定为测试组和对照组。测试组应用配方实施例1和2以及比较配方实施例2的组合物持续24周。对照组应用比较配方实施例1的组合物持续24周。并随后测量毛发密度。以1至10的得分评价毛发密度，并将结果示于下表8和图4中。甚至在第24周时针对比较配方实施例1的组合物的密度得分为2或更小。针对比较配方实施例2的组合物的密度得分比针对比较配方实施例1的组合物的得分更高，但比针对配方实施例1和2的组合物的得分更低。配方实施例1和2的组合物比比较配方实施例1和2的组合物显示出更好的评价得分，具有8或更高的平均得分。从这些结果中发现，配方实施例1和2比比较配方实施例1和2更加改善了毛发密度。
[表8]
Figure BDA0002485967820000181
实验例5.人体中毛发伸长率的测试
以与上述实验例4中相同的方式进行测试。以在第6、12和24周时每周的相对伸长率测量毛发的伸长率。结果示于下表9和图5中。发现与比较配方实施例1的组合物相比，配方实施例1和2的组合物提高了约20％至30％的伸长率。另外，尽管比较配方实施例1和比较配方实施例2的组合物的最大伸长率分别被限制为约50％和约70％，但配方实施例1和2的组合物显示出约130％的伸长率。
[表9]
第6周 第12周 第24周
比较配方实施例1 25 39 47
比较配方实施例2 40 50 67
配方实施例1 81 120 130
配方实施例2 79 111 126
实验例6.人毛真皮乳头细胞中细胞增殖效力的比较
为了比较细胞增殖的效力，以与实验例1中相同的方式对100μg/ml根据实施例1和实施例10至25的每种混合物进行测试，并将结果示于下表10中。将当用实施例1的混合物处理毛真皮乳头细胞时的细胞增殖的程度设为参照(设定为100)，并且将当用实施例10至25的混合物处理毛真皮乳头细胞时的细胞增殖的程度表示为与参照相比的相对值。
[表10]
Figure BDA0002485967820000191
Figure BDA0002485967820000201
如以上结果所示，本发明的组合物在细胞实验水平上提高了毛真皮乳头细胞的增殖、活性和寿命，并且还显示出了高的毛根产生率。另外，临床试验显示出了毛发密度和粗度以及毛发伸长效力的优异提高。特别地，证实了上述效果在量上显著高于仅包含NAADP的组合物的效果。
还证实了当每种组分的含量比在特定值范围内时，本发明的组合物对毛真皮乳头细胞表现出更优异的增殖活性。
例如，证实了当氨基酸的含量为基于100重量份的生长因子和头蛋白的4,000至40,000重量份，特别是16,000至40,000重量份时，效果是优异的。
另外，证实了当包含生物素的水溶性维生素的含量为基于100重量份的生长因子和头蛋白的240至4,000重量份，特别是1,000至4,000重量份时，效果是优异的。
另外，证实了当活性因子的含量为基于100重量份的生长因子和头蛋白的80至1600重量份，特别是160至800重量份时，效果是优异的。
另外，证实了当长链脂肪酸的含量为基于100重量份的生长因子和头蛋白的200至3,200重量份，特别是400至1,600重量份时，效果是优异的。
另外，证实了当生长因子和头蛋白的含量为基于100重量份的活化因子的6.25至125重量份，特别是12.5至50重量份时，效果是优异的。

Claims (21)

1.用于预防或治疗毛发脱落或者促进毛发生长的药物组合物，其包含：
具有由以下式(I)表示的结构的化合物或其盐；以及
选自包含以下的组的至少一种：一种或更多种天然来源的氨基酸或其盐、一种或更多种生长因子、头蛋白、一种或更多种饱和或不饱和的C8至C18长链脂肪酸或其盐、一种或更多种活性因子和一种或更多种水溶性维生素或其盐：
Figure FDA0002485967810000011
其中：
R1和R2各自独立地是H、未经取代或被卤素取代的C1-4烷基，或-CH2-CO-CH3；
W选自NH2、OH和SH；
X选自H、OH、SH、NH2和卤素；以及
Y选自OH、H、NH2和卤素。
2.根据权利要求1所述的药物组合物，其中所述式(I)化合物是烟酸腺嘌呤二核苷酸磷酸(NAADP)。
3.根据权利要求1所述的药物组合物，其中所述氨基酸选自包含以下的组：丙氨酸、精氨酸、天冬酰胺、天冬氨酸、半胱氨酸、谷氨酸、谷氨酰胺、甘氨酸、组氨酸、异亮氨酸、亮氨酸、赖氨酸、甲硫氨酸、苯丙氨酸、脯氨酸、丝氨酸、苏氨酸、色氨酸、酪氨酸和缬氨酸。
4.根据权利要求1所述的药物组合物，其中所述一种或更多种生长因子选自包含以下的组：上皮生长因子(EGF)、酸性成纤维细胞生长因子(FGF(a))、碱性成纤维细胞生长因子(FGF(b))、血管内皮生长因子(VEGF)、血小板源性生长因子(PDGF)和角质细胞生长因子(KGF)。
5.根据权利要求1所述的药物组合物，其中所述长链脂肪酸选自包含以下的组：亚麻酸、豆蔻酸、油酸和棕榈酸。
6.根据权利要求1所述的药物组合物，其中所述活性因子选自包含以下的组：肌醇、腺嘌呤、谷胱甘肽和胆固醇。
7.根据权利要求1所述的药物组合物，其中所述水溶性维生素选自包含以下的组：硫胺素(B1)、核黄素(B2)、烟酰胺(B3)、泛酸或其盐(B5)、吡哆醇(B6)、生物素(B7)、叶酸(B9)、氰钴胺素(B12)和抗坏血酸(C)。
8.根据权利要求1所述的药物组合物，其中所述组合物促进毛真皮乳头细胞的增殖。
9.根据权利要求1所述的药物组合物，其中所述组合物延长毛真皮乳头细胞的寿命。
10.根据权利要求1所述的药物组合物，其中所述组合物产生毛真皮乳头细胞的毛根。
11.根据权利要求1所述的药物组合物，其中所述组合物提高毛发的密度、粗度或长度，或其组合。
12.根据权利要求1所述的药物组合物，其中所述组合物包含：
具有式(I)的结构的所述化合物或其盐；
一种或更多种天然来源的氨基酸或其盐；
包含一种或更多种生长因子和头蛋白的混合物；
一种或更多种饱和或不饱和的C8至C18长链脂肪酸或其盐；
一种或更多种选自包含肌醇、腺嘌呤、谷胱甘肽和胆固醇的组的活性因子；以及
一种或更多种水溶性维生素或其盐。
13.根据权利要求12所述的药物组合物，其中所述组合物包含基于所述组合物的总重量的0.001重量％至1重量％的量的具有式(I)结构的所述化合物或其盐、0.001重量％至20重量％的量的所述氨基酸或其盐、0.001重量％至5重量％的量的包含生长因子和头蛋白的所述混合物、0.001重量％至5重量％的量的所述长链脂肪酸或其盐、0.001重量％至5重量％的量的所述活性因子和0.001重量％至5重量％的量的所述水溶性维生素或其盐。
14.根据权利要求12所述的药物组合物，其中所述生长因子包含：上皮生长因子(EGF)、酸性成纤维细胞生长因子(FGF(a))、碱性成纤维细胞生长因子(FGF(b))、血管内皮生长因子(VEGF)、血小板源性生长因子(PDGF)和角质细胞生长因子(KGF)，并且所述组合物中上皮生长因子(EGF)：酸性成纤维细胞生长因子(FGF(a))：碱性成纤维细胞生长因子(FGF(b))：血管内皮生长因子(VEGF)：血小板源性生长因子(PDGF)：角质细胞生长因子(KGF)：头蛋白的重量比是0.1至10∶0.1至10∶0.1至10∶0.1至10∶0.1至10∶0.1至10∶0.1至10。
15.根据权利要求14所述的药物组合物，其中所述生长因子和头蛋白包含在所述组合物中以使得上皮生长因子(EGF)：酸性成纤维细胞生长因子(FGF(a))：碱性成纤维细胞生长因子(FGF(b))：血管内皮生长因子(VEGF)：血小板源性生长因子(PDGF)：角质细胞生长因子(KGF)：头蛋白的重量比是2至6∶4至8∶4至8∶1至2∶1至2∶1至2∶1至2。
16.根据权利要求15所述的药物组合物，其中所述生长因子和头蛋白包含在所述组合物中以使得上皮生长因子(EGF)：酸性成纤维细胞生长因子(FGF(a))：碱性成纤维细胞生长因子(FGF(b))：血管内皮生长因子(VEGF)：血小板源性生长因子(PDGF)：角质细胞生长因子(KGF)：头蛋白的重量比是2至4∶2至6∶2至6∶2至6∶2至6∶2至6∶2至6。
17.根据权利要求12所述的药物组合物，其中所述组合物中氨基酸或其盐：长链脂肪酸或其盐：活性因子：水溶性维生素或其盐的重量比是100至2000∶10至200∶5至200∶10至200。
18.根据权利要求12所述的药物组合物，其中所述组合物包含：
基于100重量份的所述生长因子和头蛋白的4000重量份至40000重量份的量的所述氨基酸，
基于100重量份的所述生长因子和头蛋白的240重量份至4000重量份的量的所述水溶性维生素或其盐，
基于100重量份的所述生长因子和头蛋白的80重量份至1600重量份的量的所述活性因子，
基于100重量份的所述生长因子和头蛋白的200重量份至3200重量份的量的所述长链脂肪酸或其盐，以及
基于100重量份的所述活性因子的6.25重量份至125重量份的量的所述生长因子和头蛋白。
19.根据权利要求1至18中任一项所述的药物组合物，其中所述组合物为选自包含以下的制剂的形式：软膏剂、糊剂、凝胶剂、胶冻剂、浆液剂、气雾喷雾剂、非气雾喷雾剂、泡沫剂、乳膏剂、洗剂、溶液剂和混悬剂。
20.用于预防或改善毛发脱落或促进毛发生长的化妆品组合物，其包含：
具有由以下式(I)表示的结构的化合物或其盐；以及
选自包含以下的组的至少一种：一种或更多种天然来源的氨基酸或其盐、一种或更多种生长因子、头蛋白、一种或更多种饱和或不饱和的C8至C18长链脂肪酸或其盐、一种或更多种活性因子和一种或更多种水溶性维生素或其盐：
Figure FDA0002485967810000041
其中：
R1和R2各自独立地是H、未经取代或被卤素取代的C1-4烷基，或-CH2-CO-CH3；
W选自NH2、OH和SH；
X选自H、OH、SH、NH2和卤素；以及
Y选自OH、H、NH2和卤素。
21.根据权利要求20所述的化妆品组合物，其中所述组合物为选自包含以下的制剂的形式：生发液、毛发调理剂、毛发精华、毛发洗剂、毛发营养洗剂、洗发香波、毛发护发素、毛发处理剂、发乳、毛发营养乳、毛发保湿乳、毛发按摩乳、发蜡、毛发气雾剂、发膜、营养发膜、洗发皂、毛发清洁泡沫、发油、毛发干燥剂、护发剂、染发剂、烫发剂、毛发漂白剂、发胶、发釉、美发剂、毛发定型剂、毛发保湿剂、毛发摩丝或毛发喷雾剂。
CN201880072894.1A 2017-11-13 2018-05-30 用于预防或治疗毛发脱落或者促进毛发生长的药物组合物或化妆品组合物 Pending CN111315387A (zh)

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