CN109689046A - 包含植物雌激素作为有效成分的用于防止脱发及促进毛发生长的组合物 - Google Patents
包含植物雌激素作为有效成分的用于防止脱发及促进毛发生长的组合物 Download PDFInfo
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- CN109689046A CN109689046A CN201780055855.6A CN201780055855A CN109689046A CN 109689046 A CN109689046 A CN 109689046A CN 201780055855 A CN201780055855 A CN 201780055855A CN 109689046 A CN109689046 A CN 109689046A
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Abstract
本发明涉及包含植物雌激素作为有效成分的用于防止脱发及促进毛发生长的组合物,更详细地涉及包含作为源自豆科植物的雌激素结构类似物的植物雌激素作为有效成分的用于防止脱发及促进毛发生长的药学组合物、化妆品组合物及健康功能性食品组合物。
Description
技术领域
本申请要求于2016年9月27日申请的韩国专利申请第10-2016-0123803号的优先权,上述说明书全文为本申请的参考文献。
本发明涉及包含植物雌激素作为有效成分的用于防止脱发及促进毛发生长的组合物。
背景技术
人的毛发主要起到用于保护头皮免受到如紫外线等的外界刺激因素的防御功能,还起到用于表现个人的外在形象的美学性功能。然而,在现代社会中,由于如环境污染及强紫外线等的自然因素、如应激及激素失衡等的生理性因素而常常发生脱发,并且与仅限于成年男性的过去不同,无论男女老少均出现脱发现象,因此迫切需要用于预防及治疗这些的材料。
作为用于生成毛发的身体内的生理学性器官的毛囊(hair follicle)参与毛发的生长到保持、脱落的过程中,具体地,在出生后的发生过程中,重复进行着分为毛发的生成及所生成的毛发活跃地成长的成长期(anagen phase)、毛发退化的退行期(catagenphase)、保持到毛发脱落时的休止期(telogen phase)、引起脱发的脱发期(exogen phase)的毛发生长周期(hair cycle),使得毛发生长及保持。近年来,随着脱发现象增加且对于促进生发及毛发生长的需求增加,对毛囊的活性的关注也增加了。毛囊的活性由真皮乳头细胞引起,尤其,真皮乳头细胞的增殖及分化主要参与毛发生长周期的进行及毛发形成。在毛发生长活跃的成长期中,发生真皮乳头细胞的活跃的增殖及分化,并且在毛发的生长停止且产生脱发现象的退行期、休止期、脱发期中该细胞死亡。
因此,生发及脱发与真皮乳头细胞的增殖及死亡密切相关,因此诱导其的增殖,从而使成长期变长或抑制细胞死亡,并使退行期、休止期、脱发期变短成为备受瞩目的改善及治疗脱发的方案。并且,真皮乳头附近的细胞分裂及移动与头发的成长密切相关,在成长期从真皮乳头新生出毛发,并且细胞因各种细胞因子、激素等而被激活,并向真皮乳头发生细胞的移动,从而对毛发的生长带来影响。
现在,作为可促进生发及毛发生长的药物,经美国食品与药品管理局(FDA)批准的具代表性的药物具有米诺地尔(minoxidil)和非那司提(finasteride)。然而,这些药物伴随有副作用,例如全身毛发生长及性功能低下等,并且米诺地尔的具体作用机理还尚未明确。因此,正在努力开发在毛囊中促进真皮乳头细胞的增殖且使生长因子的表达增加的同时对人体安全的药物。
发明内容
技术问题
本发明的目的在于,提供包含植物雌激素(Phytoestrogen)作为有效成分的用于防止脱发或促进生发的药学组合物等。
然而,本发明所要实现的技术问题不局限于以上所提及的问题,本发明所属技术领域的普通技术人员可从下文中的描述来清楚地理解未提及的其他多个技术问题。
解决问题的手段
本发明提供包含选自由以下化学式1至化学式4组成的组中的一种以上的植物雌激素(Phytoestrogen)作为有效成分的用于防止脱发或促进生发的药学组合物:
化学式1:
化学式2:
化学式3:
化学式4:
上述植物雌激素(Phytoestrogen)可以源自豆科植物。
上述植物雌激素(Phytoestrogen)可使人体毛囊真皮乳头细胞的存活率。
上述植物雌激素(Phytoestrogen)可具有使人体毛发长度延伸的活性。
上述植物雌激素(Phytoestrogen)能够以0.005μM至1mM的浓度包含于上述组合物中。
作为皮肤外用药,上述药学组合物可以为选自由乳膏剂、凝胶剂、贴剂、喷雾剂、软膏剂、硬膏剂、洗剂、擦剂、糊剂及泥敷剂组成的组中的剂型。
作为本发明一实例,提供包含选自由以下化学式1至化学式4组成的组中的一种以上的植物雌激素(Phytoestroge)作为有效成分的用于防止脱发或促进生发的化妆品组合物:
化学式1:
化学式2:
化学式3:
化学式4
上述植物雌激素(Phytoestrogen)可以源自豆科植物。
上述化妆品组合物可以为发根营养液、头发洗剂、发膏、喷发剂、发用摩丝、发胶、护发素、洗发水、润发液、发膜、焗油膏、眉毛生长剂、睫毛生长剂、睫毛营养剂、宠物用沐浴露或宠物用护毛素的剂型。
作为本发明的再一实例,提供包含选自由以下化学式1至化学式4组成的组中的一种以上的植物雌激素(Phytoestroge)作为有效成分的用于防止脱发或促进生发的健康功能性食品组合物:
化学式1:
化学式2:
化学式3:
化学式4:
上述植物雌激素(Phytoestrogen)可以源自豆科植物。
作为本发明的另一实例,提供包括将包含选自由以下化学式1至化学式4组成的组中的一种以上的植物雌激素(Phytoestroge)作为有效成分的组合物给药的步骤的用于预防或治疗脱发或促进生发的方法:
化学式1:
化学式2:
化学式3:
化学式4:
作为本发明的还一实例,提供包含选自由以下化学式1至化学式4组成的组中的一种以上的植物雌激素(Phytoestroge)作为有效成分的组合物在制备脱发预防药剂或治疗药剂或生发促进剂中的应用:
化学式1:
化学式2:
化学式3:
化学式4:
发明的效果
本发明涉及包含植物雌激素(Phytoestrogen)作为有效成分的用于防止脱发或促进生发的组合物,上述植物雌激素(Phytoestrogen)具有促进永生化(immortalized)的真皮乳头细胞的增殖且与毛发组织分化相关的生长因子的表达促进效果,并且可在去除了绒毛的小鼠背部中表现出显著的生发促进效果,从而可利用于防止脱发或促进生发。
附图说明
图1为在永生化的真皮乳头细胞(Immortalized dermal papilla cell,I-DPC)的增殖促进效果中按照时间来确认的根据植物雌激素及对照组(米诺地尔)的浓度的增殖促进效果的图形且图1a至1d分别表示化学式1至化学式4。
图2为通过皮下注射来给药植物雌激素时在小鼠背部中确认生发促进效果的时间。
图3为表示通过皮下注射来给药植物雌激素时的根据绒毛成长促进的绒毛重量的增加的图形。
具体实施方式
如上所述,除了激素分泌变化之外,随着因应激引起的脱发现象增加,对可防止脱发和/或促进生发的药学组合物等的需求增加,但对人体安全的已知的化合物中,关于可有效地防止脱发和/或促进生发的化合物的报道并不多。因此,本发明人确认植物雌激素具有促进永生化(immortalized)的真皮乳头细胞的增殖且与毛发组织分化相关的生长因子的表达促进效果,并且可在去除了绒毛的小鼠背部中表现出显著的生发促进效果,从而完成了本发明。
以下,进一步详细说明本发明。
本发明提供包含选自由以下化学式1至化学式4组成的组中的一种以上的植物雌激素(Phytoestrogen)作为有效成分的用于防止脱发或促进生发的药学组合物:
化学式1:
如上所述,除了激素分泌变化之外,随着因应激引起的脱发现象增加,对可防止脱发和/或促进生发的药学组合物等的需求增加,但对人体安全的已知的化合物中,关于可有效地防止脱发和/或促进生发的化合物的报道并不多。因此,本发明人确认植物雌激素具有促进永生化(immortalized)的真皮乳头细胞的增殖且与毛发组织分化相关的生长因子的表达促进效果,并且可在去除了绒毛的小鼠背部中表现出显著的生发促进效果,从而完成了本发明。
以下,进一步详细说明本发明。
本发明提供包含选自由以下化学式1至化学式4组成的组中的一种以上的植物雌激素(Phytoestrogen)作为有效成分的用于防止脱发或促进生发的药学组合物:
化学式2:
化学式3:
化学式4:
在本发明中,“植物雌激素(Phytoestrogen)”是指存在于植物中且在动物的体内发挥雌激素性效果的非甾体化合物,尤其,包含大豆的大豆加工食品(豆乳、豆腐、大豆酱等)和各种谷物或水果类、苜蓿、四叶草等中相对包含较多。与体内所生成的内源性雌激素相比,上述植物性雌激素的活性效果仅为1/100~1/1000,但其含量更多,因此最终可获得充分的雌激素效果。本发明的上述植物雌激素源自作为豆科植物的“奥氏黄檀(DalbergiaOliveri)”,但不限定于此。
本发明的术语“防止脱发”或“促进生发”意在包括本发明所属技术领域中所使用的其他术语即促进养发或育发。
在本发明一实施例中,本发明人筛选了用于促进真皮乳头细胞的增殖的植物雌激素来作为源自豆科植物的奥氏黄檀(Dalbergia Oliveri)的雌激素结构类似物,并且在上述植物雌激素的多种有效成分中筛选了上述化学式1至化学式4的化合物。
上述植物雌激素可使人体毛囊真皮乳头细胞的存活率增加,并且可具有使人体毛发长度延伸的活性。
并且,上述植物雌激素能够以0.005μM至1mM的浓度包含于上述组合物中,优选地,能够以1μM至10μM的浓度包含,但不限定于此。其中,当上述植物雌激素的浓度小于上述浓度时,存在不具备防止脱发及促进生发的效果的问题,当大于上述浓度时,存在细胞毒性的问题。
在本发明一实施例中,确认由上述化学式1至化学式4表示的植物雌激素化合物对真皮乳头细胞的影响的结果,确认了相对于1μM至10μM浓度下永生化的真皮乳头细胞(I-DPC),显著地促进了增殖(参照图1a至图1d)。
并且,确认由上述化学式1至化学式4表示的植物雌激素化合物是否可在生物体内具有毛发生长促进效果,其结果,涂敷于去除了绒毛的小鼠的背部之后,通过经皮吸收给药或皮下注射给药时,与非给药的对照组及米诺地尔相比,可确认到绒毛的生长显著增加(参照图2及图3)。因此,与现有的合成组合物相比,本发明的化合物对人体更加无害,具有作为负责毛发的生长的核心细胞的真皮乳头细胞的促进及与毛发组织分化相关的生长因子的表达促进效果,并且在去除了绒毛的小鼠背部表现出显著的生发促进效果,因此可有效利用于防止脱发及生发促进用组合物。
优选地,上述植物雌激素作为皮肤外用组合物,包含本发明的植物雌激素化合物作为有效成分的皮肤外用药学组合物用于防止脱发及改善和促进生发的皮肤外用药,可通过制备成乳膏剂、凝胶剂、贴剂、喷雾剂、软膏剂、硬膏剂、洗剂、擦剂、糊剂或泥敷剂的皮肤外用剂形态的药学组合物来使用,但不限定于此。
本发明的化合物可用作药学上可接受的盐的形态,作为盐,由药学上可接受的游离酸(free acid)形成的酸加盐为有用的。酸加盐由如盐酸、硝酸、磷酸、硫酸、氢溴酸、氢碘酸、亚硝酸或亚磷酸等的无机酸类以及如脂肪族单羧酸盐及脂肪族二羧酸盐、苯基取代的链烷酸酯、羟基链烷酸酯及羟基链烷二酸酯、芳香酸类、脂肪族及芳香族磺酸类等的无毒性有机酸取得。作为这种药学上无毒的盐类,包含硫酸盐、焦硫酸盐、硫酸氢盐、亚硫酸盐、亚硫酸氢盐、硝酸盐、磷酸盐、磷酸一氢盐、磷酸二氢盐、偏磷酸盐、焦磷酸盐氯化物、溴化物、碘化物、氟化物、醋酸盐、丙酸盐、癸酸盐、辛酸盐、丙烯酸盐、甲酸盐、异丁酸盐、癸酸盐、庚酸盐、丙酸盐、草酸盐、丙二酸盐、琥珀酸盐、辛二酸盐、癸二酸盐、富马酸盐、马来酸盐、丁炔-1,4-二酸盐、己烷-1,6-二酸盐、苯甲酸盐、氯苯甲酸盐、甲基苯甲酸盐、二硝基苯甲酸盐、羟基苯甲酸盐、甲氧基苯甲酸盐、邻苯二甲酸盐、对苯二酸盐、苯磺酸盐、甲苯磺酸盐、氯磺酸盐、二甲苯磺酸盐、苯乙酸盐、苯丙酸盐、苯基丁酸盐、柠檬酸盐、乳酸盐、β-羟基丁酸盐、乙醇酸盐、苹果酸盐、酒石酸盐、甲磺酸盐、丙磺酸盐、萘-1-磺酸盐、萘-2-磺酸盐或扁桃酸盐。
根据本发明的酸加盐可通过常规的方法制备,例如,将上述化学式1至化学式4的化合物溶解于过量的酸酸水溶液中,然后利用例如甲醇、乙醇、丙酮或乙腈等的水混溶的有机溶剂将其盐沉淀。还可通过加热相同量的化学式1至化学式4的化合物及水中的酸或醇,然后蒸发及干燥该混合物或抽滤析出的盐来制备。
并且,可利用碱来制备药学上可接受的金属盐。碱金属或碱土金属盐例如通过将化合物溶解在过量的碱金属氢氧化物或碱土金属氢氧化物溶液中,过滤不溶性化合物盐,并蒸发及干燥滤液而获得。其中,制药方面上,优选地,制备钠盐、钾盐或钙盐来作为金属盐。并且,与此对应的银盐通过将碱金属或碱土金属盐与适当的银盐(如硝酸银)反应而获得。
并且,本发明的上述化学式1至化学式4的化合物不仅包含药学上可接受的盐,还包含可由常规的方法制备的所有盐、水合物及溶剂化物。
根据本发明的加成盐可通过常规的方法制备,例如,将化学式1至化学式4的化合物溶于如丙酮、甲醇、乙醇或乙腈等水混溶的有机溶剂中,然后加入过量的有机酸或加入无机酸的酸水溶液之后,沉淀或结晶。接着,蒸发该混合物中的溶剂或过量的酸之后,干燥以获得加成盐或抽滤析出的盐。
当将本发明的组合物用作药物时,包含化学式1至化学式4的化合物或其的药学上可接受的盐作为有效成分的药学组合物在临床给药时能够以多种如下的口服或胃肠外给药形式来制剂化并给药,但不限定于此。
作为口服给药用剂型,具有例如,片剂、丸剂、轻/软胶囊剂、液剂、悬浮剂、乳化剂、糖浆剂、颗粒剂、酏剂等,这些剂型除了有效成分之外,包含稀释剂(例如,乳糖,葡萄糖,蔗糖,甘露醇,山梨糖醇,纤维素和/或甘氨酸)、润滑剂(例如,二氧化硅,滑石,硬脂酸及其的镁盐或钙盐和/或聚乙二醇)。片剂还可包含如硅酸铝镁、淀粉糊、明胶、甲基纤维素、羧甲基纤维素钠和/或聚乙烯吡咯烷酮等的粘合剂,根据情况,可包含如淀粉、琼脂,海藻酸或其的钠盐等的崩解剂或沸腾混合物和/或吸收剂、着色剂、增香剂及甜味剂。
以本发明的化学式1至化学式4的化合物或其的药学上可接受的盐作为有效成分的药学组合物可胃肠外给药,胃肠外给药通过注入皮下注射、静脉注射、肌内注射或胸内注射的方法来进行。其中,为了制剂化为胃肠外给药用剂型,将上述化学式1至化学式4的化合物或其的药学上可接受的盐与稳定剂或缓冲剂一同混合于水中以制备溶液或悬浮液,并且可将其制备安瓿或小瓶单位剂型。上述组合物可包含灭菌和/或防腐剂、稳定剂、可湿性粉剂或乳化促进剂、用于调节渗透压的盐和/或缓冲剂等的佐剂及其他治疗上有用的物质,并且可根据作为常规的方法的混合、颗粒化或涂敷方法来制剂化。
并且,本发明的化合物对人体的剂量可根据患者的年龄、体重、性别、给药形式、健康状态及疾病严重程度而不同,当以体重为60kg的成年患者为基准时,通常为0.001~1000mg/日,优选地,为0.01~500mg/日,还可根据医生或药师的判断以规定时间间隔每日一次至数次分时段给药。
并且,本发明提供包含选自由以下化学式1至化学式4组成的组中的一种以上的植物雌激素(Phytoestroge)作为有效成分的用于防止脱发或促进生发的化妆品组合物。上述植物雌激素的具体内容如上所述:
化学式1:
化学式2:
化学式3:
化学式4:
当将本发明的化学式1至化学式4的化合物用作准药品组合物的有效成分时,可直接添加具有防止脱发及毛发生长促进效果的上述化学式1至化学式4的化合物或与其他准药品或准药品成分一同使用,可根据常规方法适当使用。有效成分的混合量可根据使用目的来适当确定。
本发明的用于防止脱发及促进毛发生长的准药品组合物在其剂型方面上不做特别限定,并且能够以本发明所属技术领域中公知的准药品的形态进行多种剂型化,以具有防止脱发及毛发生长促进效果。所剂型化的上述准药品具有发根营养液、头发洗剂、发膏、喷发剂、发用摩丝、发胶、护发素、洗发水、润发液、发膜,焗油膏,眉毛生长剂、睫毛生长剂、睫毛营养剂、宠物用沐浴露、宠物用护毛素、手清洁剂、洗涤肥皂、肥皂、消毒清洁剂、湿巾、护肤膜、软膏剂、贴片或过滤填料等,包含通常意义上的准药品。
并且,在各个剂型中,用于防止脱发及促进毛发生长的准药品组合物可根据其他准药品的剂型或使用目的等来任意筛选并调配其他多种成分。有效成分的混合量可根据使用目的来适当确定,例如,可包含常规性佐剂及载体等,例如增稠剂、稳定剂、溶解剂、维生素、颜料及香料。
优选地,以总重量为基准,上述组合物的含量分别为0.0001重量百分比至10重量百分比,当大于10重量百分比时,制备组合物时颜色及稳定性降低,当小于0.0001重量百分比时,具有其效果微乎其微的缺点。如在治疗指数中所确认,包含本发明的化学式1至化学式4的化合物作为有效成分的准药品组合物几乎不具有对细胞的毒性及副作用,因而可有效地用作准药品材料。
并且,本发明提供包含选自由以下化学式1至化学式4组成的组中的一种以上的植物雌激素(Phytoestroge)作为有效成分的用于防止脱发或促进生发的健康功能性食品组合物。上述植物雌激素的具体内容如上所述:
化学式1:
化学式2:
化学式3
化学式4:
根据本发明的食品组合物可根据本发明所属技术领域中公知的常规方法制备多种形态。作为普通食品,可向饮料(包含酒精饮料)、水果及其的加工食品(例如,水果罐头、瓶装罐头、酱、果子酱等)、鱼类、肉类及其加工食品(例如,火腿、香肠、咸牛肉等)、面包类及面类(例如,乌冬面、荞麦面、拉面、意大利面、通心粉等)、果汁、各种饮料、饼干、糖稀、乳制品(例如,黄油、奶酪等)、食用植物油、人造黄油、植物性蛋白质、蒸煮食品、冷冻食品、各种调味料(例如,大酱、酱油、酱汁等)中添加本发明的化学式1至化学式4的化合物来制备,但不限定于此。并且,作为营养佐剂,可向胶囊、片剂、丸剂等中添加本发明的化学式1至化学式4的化合物来制备,但不限定于此。并且,作为健康功能食品,例如,可通过使本发明的化学式1至化学式4的化合物本身液态化、颗粒化、胶囊化及粉末化来摄取,使得能够以茶、果汁及饮料的形态来饮用(健康饮料),但不限定于此。并且,为了以食品添加剂的形态来使用本发明的化学式1至化学式4的化合物,可制备成粉末或浓缩液的形态来使用。并且,可将本发明的化学式1至化学式4的化合物与已知的具有防止脱发及生发促进效果的公知的活性成分一同混合以组合物的形态制备。
当将本发明的化学式1至化学式4的化合物利用为健康饮料时,上述健康饮料组合物可包含各种增香剂或天然碳水化合物等来作为附加成分,例如普通饮料。如上所述的天然碳水化合物可以为如葡萄糖、果糖等的单糖、如麦芽糖、蔗糖等的二糖、如糊精、环糊精等的多糖以及如木糖醇、山梨糖醇、赤藓糖醇等的糖醇。甜味剂可利用如索马甜、甜叶菊提取物等的天然甜味剂、如糖精、阿斯巴甜等的合成甜味剂等。每100mL本发明的组合物的上述天然碳水化合物的比率通常为约0.01~0.04g,优选地,为约0.02~0.03g。
并且,本发明的化学式1至化学式4的化合物能够以防止脱发及生发促进用健康功能食品的有效成分来包含,其量为用于实现防止脱发及促进毛发生长效果的有效量,并且不做特别限定,但优选地,相对于组合物总重量时为0.01重量百分比至100重量百分比。本发明的食品组合物可与化学式1至化学式4的化合物一同通过同时混合已知的具有防止脱发及促进毛发生长效果的其他活性成分来制备。
除了上述以外,本发明的健康食品可包含各种营养剂、维生素、电解质、调味剂、着色剂、果胶酸、果胶酸的盐、海藻酸、海藻酸的盐、有机酸、保护胶体增稠剂、pH调节剂、稳定剂、防腐剂、甘油,醇或碳化剂等。此外,本发明的健康食品可包含用于制备天然果汁、果汁饮料或蔬菜饮料的果肉。这种成分可独立地或混合使用。这种添加剂的比率虽然不太重要,但通常在每100重量份的本发明的组合物的0.01~0.1重量份的范围内选择。
以下,通过实施例来详细说明本发明。然而,这些实施例用于进一步具体说明本发明,本发明的范围并不限定于这些实施例中。
实施例
实施例1.具有真皮乳头细胞(dermal papilla cells,DPC)增殖促进效果的植物
雌激素化合物的分离
将包括所干燥的奥氏黄檀(Dalbergia Oliveri)的叶子和枝杈的地上部分用100%的甲醇以每4小时超声波提取,重复3次之后,过滤提取液之后,用真空浓缩仪减压浓缩并取得了甲醇粗提取物。将其悬浮于蒸馏水中,然后用正己烷(n-hexane)和乙酸乙酯(ethylacetate,EtOAc)依次分馏,取得了各自的分馏产物。对乙酸乙酯(EtOAc)分馏产物进行硅胶柱色谱(作为流动相,己烷-丙酮40:1→1:1),并分成了小分馏。通过薄层色谱分析(TLC)来确认这些小分馏,对确认出异黄酮(isoflavonoid)的小分馏重新进行硅胶柱色谱(作为流动相,氯仿-甲醇50:1→5:1),重新分成了小分馏。对这些小分馏重新进行YMC色谱柱(水和甲醇的混合溶剂作为流动相,日本维美希(YMC)公司出品)并取得了DO-10B、DO-14、DO-17、DO-20。
对多个上述化合物进行1D NMR、2D NMR及MS光谱分析的结果,确认出DO-10B为紫罗兰酮(violanone),DO-14为(3R)-5'-methoxyvestiol,DO-17为(6aR,11aR)-3,8-二羟基-9-甲氧基紫檀烷((6aR,11aR)-3,8-dihydroxy-9-methoxypterocarpan),DO-20为3-羟基-9甲氧基紫檀烷(3-hydroxy-9 methoxyterocarpan)。将这些分离的植物雌激素化合物DO-10B、DO-14、DO-17、DO-20分别表示为化学式1至化学式4。
实施例2.植物雌激素化合物的生物功能评价
2-1.细胞培养
将源自人类的真皮乳头细胞株(Immortailzed dermal papilla cell,I-DPC;由韩国庆北大学医学院的Sung Young-Kwan教授捐赠;Shin,Seung-Hyun,et al。"Establishment and characterization of an immortalized human dermal papillacell line."BMB reports 44.8(2011):512-516.)
在添加有10%的胎牛血清(FBS)及青霉素-链霉素抗生素的毛囊真皮乳头细胞生长培养基(Follicle Dermal Papilla Cell growth Medium)中培养3日以准备了真皮乳头细胞株。在培养第3日时,将在培养皿中培养的细胞移入96-孔板,细胞附着于孔底部之后,在各个孔中将DO-10B、DO-14、DO-17、DO-20以10μM的浓度处理并培养了48小时。
2-2.植物雌激素化合物的真皮乳头细胞增殖效果的确认
米诺地尔(minoxidil)为在美国开发的口服血管扩张药物且主要用于严重的高血压,但最近确认出脱发治疗剂的功效而被用作外用药物。在本实施例中,比较了米诺地尔与上述DO-10B、DO-14、DO-17、DO-20的真皮乳头细胞增殖效果。
具体地,在与上述实施例<2-1>相同的条件下培养并准备了永生化的真皮乳头细胞(I-DPC)细胞株,以0.1μM、1μM或10μM浓度在细胞培养培养基中处理DO-10B、DO-14、DO-17、DO-20之后,总共培养了72小时。利用长时间动态活细胞成像及数据分析系统(IncucytesystemTM)来确认了在培养初始0、12、24、36、48、60及72小时中附着于孔底部的细胞的饱和度(phase object confluence,%)。
其结果,如图1a至1d所示,可确认在DO-10B、DO-14、DO-17、DO-20促进永生化的真皮乳头细胞(I-DPC)的增殖的方面上,DO-10B、DO-14、DO-17、DO-20的浓度依赖性地影响增殖。尤其,当以1μM至10μM浓度处理时,可确认到显著地促进永生化的真皮乳头细胞(I-DPC)的增殖(图1a至1d)。
2-3.通过植物雌激素的生发促进效果的确认
由于确认了DO-10B、DO-14、DO-17、DO-20促进真皮乳头细胞的增殖,当给药到生物体内时,毛发周期从休止期向成长期(anagen)诱导,并确认了是否具有实际生发促进效果。
具体地,为了确认DO-10B、DO-14、DO-17、DO-20的涂敷皮下给药时的生发促进效果,购入出生6周龄的雄性C3H/HeNCrljOri小鼠,分为阴性对照组、阳性对照组(米诺地尔处理组)及DO-10B、DO-14、DO-17、DO-20处理组,并用于实验。当小鼠为6周龄时,为了确认小鼠中的生发效果,首先利用小鼠用剃刀(clipper)去除了小鼠背部的毛。
为了确认DO-10B、DO-14、DO-17、DO-20的皮下注射时的生发促进效果,在去除了绒毛的小鼠背部以每日2~3次的周期皮下注射包含1μM的DO-10B、DO-14、DO-17、DO-20的磷酸缓冲盐溶液(PBS)并饲养了共2周。结束饲养期间后,重新用小鼠用剃刀去除背部,并测定积攒的所有毛的重量,并且比较了非给药对照组及米诺地尔给药对照组的毛重量。
其结果,如图2所示,当皮下注射DO-10B、DO-14、DO-17、DO-20时,因所有DO-10B、DO-14、DO-17、DO-20而毛发周期诱导为成长期,当用肉眼确认时,与非给药对照组相比,毛显著生长(图2),当测量毛的重量时,与非给药对照组相比,毛的重量为约2倍以上的水平。不仅如此,可确认与米诺地尔给药对照组相比,为同等以上的水平(图3)。
因此,通过DO-10B、DO-14、DO-17、DO-20,毛发的生长被促进,现在,与作为可促进生发及毛发生长的代表性药物的米诺地尔相比,可确认出表现同等水平以上的生发效果。
在下文中说明包含本发明的化合物的组合物的制剂例,但本发明不是为了限定这些,而是仅仅为了具体说明。
制剂例1:散剂的制备
植物雌激素:20mg
乳糖水合物:100mg
滑石:10mg
混合上述的多个成分并填充于密封袋中来制备了散剂。
制剂例2:片剂的制备
植物雌激素:10mg
玉米淀粉:100mg
乳糖水合物:100mg
硬脂酸镁:2mg
混合上述的成分之后,根据常规的片剂的制备方法来压片以制备了片剂。
制剂例3:胶囊剂的制备
植物雌激素:10mg
微晶纤维素:3mg
乳糖水合物:14.8mg
硬脂酸镁:0.2mg
混合上述的成分之后,根据常规的胶囊剂的制备方法,通过向明胶胶囊中填充来制备了胶囊剂。
制剂例4:注射剂的制备
植物雌激素:10mg
甘露醇:180mg
注射用灭菌蒸馏水:2974mg
磷酸一氢钠:26mg
混合上述的成分之后,根据常规的注射剂的制备方法,以每1安瓿(2mL)的上述成分含量制备。
制剂例5:液剂的制备
植物雌激素:10mg
异构糖:10mg
甘露醇:5mg
纯净水:适量
柠檬香:适量
根据常规的制备方法,将上述的成分加入纯净水中溶解之后,加入适量柠檬,然后加入纯净水调节为总体积100mL,然后灭菌并填充于棕色瓶中以制备了液剂。
制剂例6:健康功能食品的制备
植物雌激素:10mg
维生素混合物:适量
维生素A醋酸盐:70μg
维生素E:1.0mg
维生素B1:0.13mg
维生素B2:0.15mg
维生素B6:0.5mg
维生素B12:0.2μg
维生素C:10mg
生物素:10μg
烟酸酰胺:1.7mg
叶酸:50μg
泛酸钙:0.5mg
矿物混合物:适量
硫酸亚铁:1.75mg
氧化锌:0.82mg
碳酸镁镁:25.3mg
磷酸一钾:15mg
磷酸二钙:55mg
柠檬酸钾钾:30mg
碳酸钙:100mg
氯化镁镁:24.8mg
上述的维生素及矿物质混合物的组成比以比较适合于健康食品的成分作为优选实施例来进行了混合组成,但其调配比可任意改变,根据常规的健康食品制备方法混合上述的成分之后制备颗粒,并可根据常规的方法来用于健康食品组合物的制备中。
制剂例7:健康饮料的制备
植物雌激素:10mg
维生素C:15g
维生素E(粉末):100g
乳酸铁:19.75g
氧化锌:3.5g
烟酸酰胺:3.5g
维生素A:0.2g
维生素B1:0.25g
维生素B2:0.3g
纯净水:定量
根据常规的健康饮料制备方法混合上述的成分之后,在85℃温度下搅拌加热约1小时,然后过滤所制备的溶液并放入已灭菌的2L容器中,密封灭菌之后冷藏储存,然后用于本发明的健康饮料组合物的制备中。
上述组成比以比较适合于偏好的饮料的成分作为优选实施例来进行了混合组成,但可根据需求阶层或需求国家、使用用途等地域性、民族性偏好度来任意变形其调配比。
以下,说明包含本发明的化合物的化妆品组合物的制备例,但仅用于具体说明本发明而不是用作限定。
制备例1:营养化妆水(乳液)
植物雌激素:2.0重量百分比
角鲨烷:5.0重量百分比
蜂蜡:4.0重量百分比
聚山梨酯60:1.5重量百分比
脱水山梨糖醇倍半萜:1.5重量百分比
液体石蜡:0.5重量百分比
辛酸/癸酸甘油三酯:5.0重量百分比
甘油:3.0重量百分比
丁二醇:3.0重量百分比
丙二醇:3.0重量百分比
羧基乙烯基聚合物:0.1重量百分比
三乙醇胺:0.2重量百分比
防腐剂、色素、香料:适量
加纯净水至100重量百分比
上述的调配比以比较适合于营养化妆水的成分作为优选实施例来进行了混合组成,但其调配比可任意改变,并可根据普通的化妆品领域中的制备方法来制备。
制备例2:柔肤水(润肤露)
植物雌激素:2.0重量百分比
甘油:3.0重量百分比
丁二醇:2.0重量百分比
丙二醇:2.0重量百分比
羧基乙烯基聚合物:0.1重量百分比
PEG12壬基苯基醚:0.2重量百分比
聚山梨酯80:0.4重量百分比
乙醇:10.0重量百分比
三乙醇胺:0.1重量百分比
防腐剂、色素、香料:适量
加纯净水至100重量百分比
上述的调配比以比较适合于柔肤水的成分作为优选实施例来进行了混合组成,但其调配比可任意改变,并可根据普通的化妆品领域中的制备方法来制备。
制备例3:营养霜
植物雌激素:2.0重量百分比
聚山梨酯60:1.5重量百分比
脱水山梨糖醇倍半萜:0.5重量百分比
PEG60硬化蓖麻油:2.0重量百分比
液体石蜡:10重量百分比
角鲨烷:5.0重量百分比
辛酸/癸酸甘油三酯:5.0重量百分比
甘油:5.0重量百分比
丁二醇:3.0重量百分比
丙二醇3.0重量百分比
三乙醇胺0.2重量百分比
防腐剂:适量
色素:适量
香料:适量
加纯净水至100重量百分比
上述的调配比以比较适合于营养霜的成分作为优选实施例来进行了混合组成,但其调配比可任意改变,并可根据普通的化妆品领域中的制备方法来制备。
制备例4:按摩霜
植物雌激素:1.0重量百分比
蜂蜡:10.0重量百分比
聚山梨酯60:1.5重量百分比
PEG60硬化蓖麻油:2.0重量百分比
脱水山梨糖醇倍半萜:0.8重量百分比
液体石蜡:40.0重量百分比
角鲨烷:5.0重量百分比
辛酸/癸酸甘油三酯:4.0重量百分比
甘油:5.0重量百分比
丁二醇:3.0重量百分比
丙二醇:3.0重量百分比
三乙醇胺:0.2重量百分比
防腐剂、色素、香料:适量
加纯净水至100重量百分比
上述的调配比以比较适合于按摩霜的成分作为优选实施例来进行了混合组成,但其调配比可任意改变,并可根据普通的化妆品领域中的制备方法来制备。
制备例4:护肤膜
植物雌激素:1.0重量百分比
聚乙烯醇:13.0重量百分比
羧甲基纤维素钠:0.2重量百分比
甘油:5.0重量百分比
尿囊素:0.1重量百分比
乙醇:6.0重量百分比
PEG12壬基苯基醚:0.3重量百分比
聚山梨酯60:0.3重量百分比
防腐剂、色素、香料:适量
加纯净水至100重量百分比
上述的调配比以比较适合于护肤膜的成分作为优选实施例来进行了混合组成,但其调配比可任意改变,并可根据普通的化妆品领域中的制备方法来制备。
制备例6:凝胶剂
植物雌激素:0.5重量百分比
乙二胺乙酸钠:0.05重量百分比
甘油:5.0重量百分比
羧基乙烯基聚合物:0.3重量百分比
乙醇:5.0重量百分比
PEG60硬化蓖麻油:0.5重量百分比
三乙醇胺:0.3重量百分比
防腐剂、色素、香料:适量
加纯净水至100重量百分比
上述的调配比以比较适合于凝胶剂的成分作为优选实施例来进行了混合组成,但其调配比可任意改变,并可根据普通的化妆品领域中的制备方法来制备。
上述调配比以比较适合于化妆品组合物的成分作为优选实施例来进行了混合组成,但可适用于包含其他的炫彩化妆品的多种用途的化妆品,根据其功效可薄涂于人体中来进行涂抹的药剂,即,可利用于软膏制备,并且根据需求阶层或需求国家、使用用途等地域性、民族性偏好度来任意变形其调配比。
Claims (13)
1.一种用于防止脱发或促进生发的药学组合物,其特征在于,包含选自由以下化学式1至化学式4组成的组中的一种以上的植物雌激素作为有效成分:
化学式1:
化学式2:
化学式3:
化学式4:
2.根据权利要求1所述的用于防止脱发或促进生发的药学组合物,其特征在于,上述植物雌激素源自豆科植物。
3.根据权利要求1所述的用于防止脱发或促进生发的药学组合物,其特征在于,上述植物雌激素使人体毛囊真皮乳头细胞的存活率增加。
4.根据权利要求1所述的用于防止脱发或促进生发的药学组合物,其特征在于,上述植物雌激素具有使人体毛发长度延伸的活性。
5.根据权利要求1所述的用于防止脱发或促进生发的药学组合物,其特征在于,上述植物雌激素以0.005μM至1mM的浓度包含于上述组合物中。
6.根据权利要求1所述的用于防止脱发或促进生发的药学组合物,其特征在于,作为皮肤外用药,上述药学组合物为选自由乳膏剂、凝胶剂、贴剂、喷雾剂、软膏剂、硬膏剂、洗剂、擦剂、糊剂及泥敷剂组成的组中的剂型。
7.一种用于防止脱发或促进生发的化妆品组合物,其特征在于,包含选自由以下化学式1至化学式4组成的组中的一种以上的植物雌激素作为有效成分:
化学式1:
化学式2:
化学式3:
化学式4:
8.根据权利要求7所述的用于防止脱发或促进生发的化妆品组合物,其特征在于,上述植物雌激素源自豆科植物。
9.根据权利要求7所述的用于防止脱发或促进生发的化妆品组合物,其特征在于,上述化妆品组合物为发根营养液、头发洗剂、发膏、喷发剂、发用摩丝、发胶、护发素、洗发水、润发液、发膜、焗油膏、眉毛生长剂、睫毛生长剂、睫毛营养剂、宠物用沐浴露或宠物用护毛素的剂型。
10.一种用于预防或治疗脱发或促进生发的方法,其特征在于,包括将包含选自由以下化学式1至化学式4组成的组中的一种以上的植物雌激素作为有效成分的组合物给药的步骤:
化学式1:
化学式2:
化学式3:
化学式4:
11.根据权利要求10所述的用于防止脱发或促进生发的健康功能性食品组合物,其特征在于,上述植物雌激素源自豆科植物。
12.一种用于预防或治疗脱发或促进生发的方法,其特征在于,包括将包含选自由以下化学式1至化学式4组成的组中的一种以上的植物雌激素作为有效成分的组合物给药的步骤:
化学式1:
化学式2:
化学式3:
化学式4:
13.一种组合物在制备脱发预防药剂或治疗药剂或生发促进剂中的应用,其特征在于,上述组合物包含选自由以下化学式1至化学式4组成的组中的一种以上的植物雌激素作为有效成分:
化学式1:
化学式2:
化学式3:
化学式4:
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KR1020160123803A KR101824497B1 (ko) | 2016-09-27 | 2016-09-27 | 피토에스트로겐을 유효성분으로 포함하는 탈모방지 및 모발 성장 촉진용 조성물 |
PCT/KR2017/010659 WO2018062820A1 (ko) | 2016-09-27 | 2017-09-27 | 피토에스트로겐을 유효성분으로 포함하는 탈모방지 및 모발 성장 촉진용 조성물 |
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JP2002205922A (ja) * | 2001-01-09 | 2002-07-23 | Shiseido Co Ltd | 毛髪成長期延長剤 |
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WO1996039832A1 (en) * | 1995-06-07 | 1996-12-19 | Kung Patrick C | Compounds and methods for promoting hair growth |
JP2002205922A (ja) * | 2001-01-09 | 2002-07-23 | Shiseido Co Ltd | 毛髪成長期延長剤 |
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CN114585383A (zh) * | 2019-10-17 | 2022-06-03 | 艾弼生物科技有限公司 | 包含rip激酶抑制剂的用于防脱发或促生发的组合物 |
CN114585383B (zh) * | 2019-10-17 | 2024-04-19 | 艾弼生物科技有限公司 | 包含rip激酶抑制剂的用于防脱发或促生发的组合物 |
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