CN112004536B - 用于预防或治疗脱发的组合物 - Google Patents
用于预防或治疗脱发的组合物 Download PDFInfo
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- CN112004536B CN112004536B CN201980025762.8A CN201980025762A CN112004536B CN 112004536 B CN112004536 B CN 112004536B CN 201980025762 A CN201980025762 A CN 201980025762A CN 112004536 B CN112004536 B CN 112004536B
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Abstract
本发明涉及用于预防或治疗脱发的药物组合物或化妆品组合物，所述组合物均包含作为活性成分的特定化合物或其药学上可接受的盐。所述化合物在毛发生长被抑制的毛囊组织中表现出优异的毛发生长改善效果，且没有细胞毒性，因此可更有效地预防、改善或治疗脱发。
Description
技术领域
本发明涉及用于预防或治疗脱发的组合物，所述组合物包含作为活性成分的特定化合物。
背景技术
人的毛发是非常重要的，因为它在社会和性交流中起着独特的作用，而且它在保护皮肤和头皮中起着主要作用。因此，对毛发和脱发的研究正在不断进行，并且对用于预防和治疗脱发的组合物的研究和开发也在不断进行。近年来，对与毛发生长和脱发机制有关的许多调控因子(特别是与毛发周期中的毛发生长初期、毛发生长中期和休止期有关的调控因子)的研究都得到了积极引导，并不断有报道称这些调控因子受其受体的信号传导的调控。
目前市场上存在与毛发生长有关的许多种类的产品，但其预防脱发和毛发生长的效果大多不足或是暂时性的，因此不能满足使用者的需求，功效和安全性的证据数据也不足。US FDA批准且可商购的米诺地尔(Minoxidil)和非那雄胺(Propecia)也在一定程度上被认为具有效果，但有一个困难是，当停止使用时，据报道会出现严重的副作用，如脱发复发或性功能障碍。
因此，近年来，进行了许多尝试以从天然产物中开发出用于预防脱发和促进毛发生长的副作用小的新活性成分。通过能够主要激活发根和促进血液循环的物质和各种草药而进行的东方医学方法研究主要集中在，通过对诸如僵蚕(Batryticatus Bombyx)和土香薷(Elscholtzia patrini)的天然提取物进行的搜寻实验来筛选出有效物质，此类现有技术包括韩国专利号682573和1287052。然而，这种传统的提取工艺的优点是工艺是简单的且可容易地施用，但活性成分的提取效率必然较低。
因此，需要开发一种新的脱发治疗剂，其能够克服包含这种提取物的用于治疗脱发的组合物的缺点。
发明内容
技术问题
本发明的目的在于提供用于预防或治疗脱发的药物组合物，所述药物组合物包含作为活性成分的特定化合物。
本发明的另一目的在于提供用于预防或改善脱发的化妆品组合物，所述化妆品组合物包含作为活性成分的特定化合物。
技术方案
为了实现上述目的，本发明提供了用于预防或治疗脱发的药物组合物，所述药物组合物包含由如下化学式1或化学式2表示的化合物或其药学上可接受的盐作为活性成分。
为了实现上述另一目的，本发明提供了用于防止或改善脱发的化妆品组合物，所述化妆品组合物包含由如下化学式1或化学式2表示的化合物或其药学上可接受的盐作为活性成分。
[化学式1]
[化学式2]
有益效果
本发明涉及用于预防或治疗脱发的组合物，所述组合物包含由化学式1或化学式2表示的化合物或其药学上可接受的盐作为活性成分，其中，所述化合物为并且在由15-脱氧-Δ12,14-前列腺素J2诱导脱发的头皮组织中表现出改善毛发生长抑制作用的活性，并且也没有细胞毒性，因此其可通过优异的毛囊生长抑制改善效果而被有效地用作有效预防或治疗脱发的组合物。
附图说明
图1示出了评估雷马曲班(ramatroban)在人毛囊组织中改善15d-PGJ2的人毛囊生长抑制的结果(#：p<0.005)。
图2示出了评估2-[3-[(4-氟苯基)磺酰基-甲基氨基]-1,2,3,4-四氢咔唑-9-基]乙酸(化合物3)在人毛囊组织中改善15d-PGJ2的人毛囊生长抑制的结果(#：p<0.005)。
图3示出了评估[5-氟-2-甲基-3-(喹啉-2-基甲基)吲哚-1-基]乙酸(化合物4)在人毛囊组织中改善15d-PGJ2的人毛囊生长抑制的结果(#：p<0.005)。
图4示出了评估由本发明化学式1表示的化合物1在人毛囊组织中的毒性的结果。
图5示出了评估本发明化合物1在人毛囊组织中改善15d-PGJ2的人毛囊生长抑制的结果(#：p<0.005，*：p<0.05)。
图6示出了评估由本发明化学式2表示的化合物2在人毛囊组织中的毒性的结果。
图7示出了评估本发明化合物2在人毛囊组织中改善15d-PGJ2抑制的人毛囊生长抑制的结果(#：p<0.005，*：p<0.05)。
具体实施方式
下面，将对本发明进行更详细地描述。
本发明提供了用于预防或治疗脱发的药物组合物，所述药物组合物包含由如下化学式1或化学式2表示的化合物或其药学上可接受的盐作为活性成分。
[化学式1]
[化学式2]
在本发明的一个实施方式中，所述化合物在毛囊组织中显示出恢复毛发生长的效果而没有细胞毒性，其中毛发生长被15-脱氧-Δ12,14-前列腺素J2抑制。即，上述化合物可以恢复毛囊组织中被抑制的毛发生长过程，因此可以有效地预防或治疗脱发。
基于100重量份的所述组合物，能够以0.0001重量份至1重量份的量含有所述化合物，但不限于此。
本发明中使用的术语“预防”是指通过给予组合物来抑制或延缓疾病的任何作用，所述组合物包含由化学式1(以下称为化合物1)或化学式2(以下称为化合物2)表示的化合物或其药学上可接受的盐。此外，在本发明中使用的术语“治疗”是指通过给予组合物来改善或治愈疾病症状的任何作用，所述组合物包含由化学式1或化学式2表示的化合物或其药学上可接受的盐。
由本发明的化学式1或化学式2表示的化合物能够以药学上可接受的盐的形式使用，并且这种盐包括由药学上可接受的游离酸形成的酸加成盐和由碱形成的金属盐。无机酸和有机酸可用作游离酸，无机酸可以包括盐酸、硫酸、溴酸、亚硫酸或磷酸等。金属盐包括碱金属盐或碱土金属盐，并且钠盐、钾盐或钙盐是有用的。
对于给予，除了上述活性成分外，本发明的组合物可包含药学上可接受的载体、赋形剂或稀释剂。载体、赋形剂和稀释剂的实例包括乳糖、葡萄糖、蔗糖、山梨醇、甘露醇、木糖醇、赤藓糖醇、麦芽糖醇、淀粉、阿拉伯树胶、海藻酸盐、明胶、磷酸钙、硅酸钙、纤维素、甲基纤维素、微晶纤维素、聚乙烯吡咯烷酮、水、羟基苯甲酸甲酯、羟基苯甲酸丙酯、滑石粉、硬脂酸镁和矿物油。
本发明的药物组合物可根据常规方法以口服制剂的形式配制和使用，所述口服制剂例如散剂、颗粒剂、片剂、胶囊剂、混悬剂、乳剂、糖浆剂、气雾剂(aerosol)、外部制剂、栓剂或无菌注射溶液。具体而言，当配制时，其可使用常用的稀释剂或赋形剂制备，例如填充剂、加重剂、粘合剂、润湿剂、崩解剂和表面活性剂。
用于口服给予的固体制剂包括片剂、丸剂、散剂、颗粒剂、胶囊剂等，但不限于这些。此种固体制剂可通过将至少一种赋形剂(例如淀粉、碳酸钙、蔗糖、乳糖、明胶等)与由化学式1或化学式2表示的化合物或其药学上可接受的盐混合来制备。此外，除了简单的赋形剂外，还可以使用例如硬脂酸镁和滑石粉的润滑剂。除了口服使用的液体和液体石蜡外，固体制剂还可以通过添加各种赋形剂(例如润湿剂、甜味剂、芳香剂、防腐剂等)来制备。
用于肠胃外给予的制剂包括无菌水性溶液、非水性溶剂、混悬剂(suspension)、乳剂、冻干制剂和栓剂。作为非水性溶剂和助悬剂(suspending agent)，可使用丙二醇、聚乙二醇、植物油(例如橄榄油)、可注射酯(例如油酸乙酯)等。作为栓剂的基质，可使用witepsol、聚乙二醇(macrosol)、吐温61、可可脂、月桂精(laurin)、甘油明胶等。
本发明组合物的适宜剂量根据患者的条件和体重、疾病的严重程度、药物的形式和时间而变化，但可由本领域技术人员适当地进行选择。因此，药学上可接受的盐的日剂量优选为1mg/kg至500mg/kg，且可根据需要每日给予一次至数次，但可适当增加或减少。
所述化合物能够恢复毛囊组织中被抑制的毛发生长过程，并且能够更有效地预防或改善脱发。
基于100重量份的所述组合物，能够以0.0001重量份至1重量份的量含有所述化合物，但不限于此。
此外，本发明提供了用于预防或改善脱发的化妆品组合物，所述化妆品组合物包含由如下化学式1或化学式2表示的化合物或其药学上可接受的盐作为活性成分。
[化学式1]
[化学式2]
所述化合物能够恢复毛囊组织中被抑制的毛发生长过程，并能够更有效地预防或改善脱发。
基于100重量份的所述组合物，能够以0.0001重量份至1重量份的量含有所述化合物，但不限于此。
在本发明的一个实施方式中，所述化妆品组合物可为选自于由如下组成的组中的任一种制剂：生发液(hair tonic)、护发素(hair conditioner)、亮发素(hair essence)、头发洗剂(hair lotion)、头发营养洗剂(hair nutrition lotion)、洗发香波、护发素、焗油膏(hair treatment)、发乳(hair cream)、头发营养霜、头发保湿霜、头发按摩霜、发蜡、头发气雾剂(hair aerosol)、发膜、头发营养膜、发皂(hair soap)、洗发乳(haircleansing foam)、头发干洗剂(hair drying preparation)、护发护理剂(hairpreservation treatment)、染发剂、卷发剂、头发去色剂、发胶(hair gel)、发釉、美发剂(hair dressinger)、粘发剂、润发膏(hair moisturizer)、发用摩丝(hair mousse)和头发喷雾剂(hair spray)，但不限于此。
除了活性成分外，本发明的化妆品组合物还可包含通常可接受的成分，并且可包含诸如抗氧化剂、稳定剂、增溶剂、维生素、染料和芳香剂的常规佐剂以及载体。
当本发明的制剂是糊剂、霜剂或凝胶时，可将动物油、植物油、蜡、石蜡、淀粉、黄芪胶、纤维素衍生物、聚乙二醇、硅酮、膨润土、二氧化硅、滑石粉或氧化锌用作载体组分。
当本发明的制剂是散剂或喷雾剂时，可将乳糖、滑石粉、二氧化硅、氢氧化铝、硅酸钙或聚酰胺粉末用作载体组分，并且特别地，在喷雾剂的情况下，可额外包含推进剂，例如氯氟烃、丙烷/丁烷或二甲醚。
当本发明的制剂是溶液或乳剂时，使用溶剂、增溶剂或乳化剂作为载体组分，例如水、乙醇、异丙醇、碳酸乙酯、乙酸乙酯、苄醇、苯甲酸苄酯、丙二醇、1,3-丁二醇油(1,3-butylglycol oil)、甘油脂肪酸酯(glycerol aliphatic ester)、聚乙二醇或失水山梨醇的脂肪酸酯。
当本发明的制剂是混悬剂时，可将如下用作载体组分：液体稀释剂，例如水、乙醇或丙二醇；助悬剂，例如乙氧基化的异硬脂醇、聚氧乙烯山梨醇酯和聚氧乙烯失水山梨醇酯、微晶纤维素、偏氢氧化铝(aluminum metahydroxide)、膨润土、琼脂或黄芪胶等。
此外，可将本发明的化妆品组合物制备为护发组合物，所述护发组合物包含适合施用于头发的载体或载体混合物。载体包括除溶剂以外的载体组分或常用于护发组合物的载体组分，并且占总组合物组成的约0.5％至99.5％、优选约5.0％至99.5％、最优选约10.0％至90.0％。不管配制的头发组合物在使用后是保留在头发上(如头发喷雾剂、发用摩丝、生发液等)还是被洗掉(如香波、护发素等)，均通过所使用的共聚物来对作为载体的溶剂进行选择。在本发明中使用的合适的溶剂优选包括水、低级醇(乙醇、异丙醇等)、水醇基(hydroalcohol-based)混合物、烃(异丁烷、己烷、癸烯等)、丙酮、卤代烃(氟利昂等)、烃酯(乙酸乙酯、邻苯二甲酸二丁酯等)、挥发性硅酮衍生物、硅氧烷(苯基五甲基二硅氧烷、甲氧丙基五甲基环四硅氧烷、氯丙基五甲基二硅氧烷、羟丙基五甲基二硅氧烷、八甲基环四硅氧烷、十甲基环五硅氧烷等)以及它们的混合物。
实施例
以下，将通过实施例对本发明进行更详细地描述。这些实施例仅旨在对本发明进行更详细地说明，并且对本领域技术人员而言显而易见的是，本发明的范围不受根据本发明要旨的这些实施例的限制。
<实施例1>本发明所述的化合物的抗脱发效果的确认
首先，15-脱氧-Δ12,14-前列腺素J2(15d-PGJ2，一种已被批准作为过敏性鼻炎治疗剂并被广泛使用的化合物)、雷马曲班(BAY-u3405)、本发明的化合物1和化合物2、2-[3-[(4-氟苯基)磺酰基-甲基氨基]-1,2,3,4-四氢咔唑-9-基]乙酸(以下称为化合物3)和[5-氟-2-甲基-3-(喹啉-2-基甲基)吲哚-1-基]乙酸(以下称为化合物4)购自Cayman化学(密歇根州，USA)，并在实验中使用。
人发组织由庆北国立大学毛发移植中心提供，经毛发移植患者同意(IRB项目编号：KNUH2014-02-023)，通过将毛囊从头皮组织中分离出来用于实验。在每种化合物处理后，通过使用含有2mM L-谷氨酰胺、100U/mL链霉素和10ng/ml氢化可的松的Williams E培养基(Sigma，USA)在37℃的CO2培养箱中孵育6天来制备人发组织，并使用显微镜测量生长长度。
将来自上述实验的数据表示为平均值±SEM。对于统计处理，采用学生t检验测量每组的平均偏差，在p<0.005和p<0.05时被认为是显著的。
因此，首先，如图1所示，作为用浓度为10μM的15d-PGJ2处理人毛囊的结果，发现毛囊生长减少了1/3，这与Garza等(2012)的15d-PGJ2抑制毛囊生长的研究结果一致。当同时处理15d-PGJ2和雷马曲班(10nM～1000nM)时，与仅用15d-PGJ2(10μM)处理相比，由15d-PGJ2抑制的毛囊生长没有恢复。
此外，参考图2，当同时处理15d-PGJ2和化合物3(1nM～10000nM)时，由15d-PGJ2抑制的毛囊生长没有恢复。参考图3，即使当同时处理15d-PGJ2和化合物4(1nM～100nM)时，由15d-PGJ2抑制的毛囊生长也没有恢复。
另一方面，参考图4，当将化合物1以0.1nM～10nM的浓度在单独培养的人毛囊上进行处理时，与未经化合物1处理的组相比无显著差异。因此，证实了化合物1在上述浓度下对培养的人毛囊是安全的。
此外，参考图5，当同时处理15D-PGJ2和化合物1时，化合物1浓度越高，为0.1nM、1nM和10nM，发现与仅处理15d-PGJ2(10μM)时相比，由15D-PGJ2抑制的毛囊生长分别显著增加至108％、194％和234％(基于当15d-PGJ2单独处理时为100％的毛囊长度)。
同时，参考图6，当将化合物2以0.1μM～10μM的浓度在单独培养的人毛囊上进行处理时，与未经化合物2处理的组相比无显著差异。因此，证实了化合物2在上述浓度下对培养的人毛囊是安全的。
此外，参考图7，当同时处理15D-PGJ2和化合物2(0.5μM、1μM)时，与仅处理15D-PGJ2(10μM)相比，由15D-PGJ2抑制的毛囊生长显著增加。
因此，本发明所述的化合物1和化合物2在PGD2及其代谢物(15d-PGJ2)表达高的脱发区域对毛囊生长有效，因此，使用化合物1和化合物2作为活性成分，可以有效地将其用作预防或治疗脱发的组合物。
虽然已经参照本发明的具体实施方式对本发明进行了具体描述，但是显然，该具体说明仅仅是优选实施方式，并且对于本领域技术人员来说，本发明范围并不会因此而受到限制。即，本发明的实际范围由所附权利要求书及其等同物限定。
Claims (10)
1.由化学式1表示的化合物或其药学上可接受的盐作为活性成分在制备用于预防或治疗由毛囊组织中的毛发生长的抑制而引起的脱发的药物组合物中的用途，
[化学式1]
2.由化学式2表示的化合物或其药学上可接受的盐作为活性成分在制备用于预防或治疗脱发的药物组合物中的用途，
[化学式2]
3.如权利要求2所述用途，其中，所述脱发是由毛囊组织中的毛发生长的抑制而引起的脱发。
4.如权利要求1-3中任一项所述的用途，其中，基于100重量份的所述组合物，以0.0001重量份至1重量份的量含有所述化合物。
5.由化学式1表示的化合物或其药学上可接受的盐作为活性成分在制备用于预防或改善由毛囊组织中的毛发生长的抑制而引起的脱发的化妆品组合物中的用途，
[化学式1]
6.由化学式2表示的化合物或其药学上可接受的盐作为活性成分在制备用于预防或改善脱发的化妆品组合物中的用途，
[化学式2]
7.如权利要求6所述的用途，其中，所述脱发是由毛囊组织中的毛发生长的抑制而引起的脱发。
8.如权利要求5-7中任一项所述的用途，其中，所述化妆品组合物为选自于由如下组成的组中的任一种制剂：生发液、护发素、亮发素、洗发香波、焗油膏、发乳、发蜡、头发气雾剂、发膜、发皂、染发剂、卷发剂、头发去色剂、发胶、发釉、粘发剂、润发膏、发用摩丝和头发喷雾剂。
9.如权利要求5-7中任一项所述的用途，其中，所述化妆品组合物为选自于由如下组成的组中的任一种制剂：头发营养洗剂、头发营养霜、头发保湿霜、头发按摩霜、头发营养膜、洗发乳、头发干洗剂和美发剂。
10.如权利要求5-7中任一项所述的用途，其中，所述化妆品组合物为选自于由如下组成的组中的任一种制剂：头发洗剂和护发护理剂。
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