CN116249514A - 包含奶蓟花提取物作为有效成分的用于防止脱发或促进生发的组合物 - Google Patents
包含奶蓟花提取物作为有效成分的用于防止脱发或促进生发的组合物 Download PDFInfo
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- CN116249514A CN116249514A CN202280005317.7A CN202280005317A CN116249514A CN 116249514 A CN116249514 A CN 116249514A CN 202280005317 A CN202280005317 A CN 202280005317A CN 116249514 A CN116249514 A CN 116249514A
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Abstract
本发明提供一种包含奶蓟花提取物作为有效成分的用于防止脱发或促进生发的组合物。更具体地涉及包含奶蓟花提取物作为有效成分的化妆品组合物、药物组合物以及食品组合物,通过诱导因衰老而减少的真皮乳头细胞的增殖来促进毛发生长,抑制衰老相关β‑半乳糖苷酶(SA‑β‑Gal)的活性和衰老相关分泌表型的产生,从而阻碍真皮乳头细胞的衰老,激活真皮乳头细胞来防止脱发并促进生发。根据本发明的组合物由于没有皮肤刺激性和细胞毒性而具有优异的人体安全性,促进真皮乳头细胞的增殖,并且在抑制真皮乳头细胞的衰老方面非常有效,因此可以有效用作用于防止脱发和促进生发的化妆品组合物、药物组合物或食品组合物的有效成分。
Description
技术领域
本发明涉及一种包含奶蓟花提取物作为有效成分的用于防止脱发或促进生发的组合物。更具体地涉及包含奶蓟花提取物作为有效成分的化妆品组合物、药物组合物以及食品组合物,通过诱导因衰老而减少的真皮乳头细胞的增殖来促进毛发生长,抑制衰老相关β-半乳糖苷酶(SA-β-Gal)的活性和衰老相关分泌表型的产生,从而阻碍真皮乳头细胞的衰老,激活真皮乳头细胞来防止脱发并促进生发。
背景技术
随着科学发展,许多医学领域正在报道慢性病的病因和各种治疗方法。特别是现代社会正在积极寻求治疗心理问题的方法。虽然脱发不是病理性问题,但会造成审美和心理压力。因此严重时可能会导致继发性疾病,如自卑或社交恐惧症。
脱发,以前被认为是衰老的一部分,但现代社会的年轻人中也有很高的出现率,而已经成为对外观影响最大的原因之一。脱发的发病年龄在20~39岁中约占50%,男性为29.8岁,女性为33.6岁,仅2018年在韩国接受脱发治疗的人数就达224688人。因此,韩国脱发治疗市场接近4万亿韩元,包括治疗剂、医疗器械、洗发素和中药材等。据知,脱发的原因包括各种因素,如由于不平衡的饮食习惯和缺铁引起的贫血、药物的副作用、使用染色或烫发等强烈的化学产品、荷尔蒙变化、甲状腺功能减退、压力、头发处理习惯、抑郁、温度变化极端的季节变化等。
脱发的类型主要分为疤痕性脱发和非疤痕性脱发,疤痕性脱发是因大疤痕而毛囊被破坏,因此毛发无法再生;非疤痕性脱发是未形成疤痕而毛囊得以维持,在症状部位消失后毛发再生。脱发治疗剂或防止剂的应用集中于疤痕性脱发。将使毛发生长的同时防止脱发的产品称为防脱发剂,定义如下:给毛根部提供营养来使毛发长出的是生发剂,促进头皮血液循环而有助于预防脱发的是育毛剂,将稀疏的软发变为健康的硬发的是养发剂(JYLim et al.,Kor.J.Aesthet.Cosmetol.,12(6):767-772,2014)。
在疤痕性脱发中,雄性激素是重要病因的雄激素性脱发占所有脱发症状的80%左右。主要原因是遗传因素、血液中雄性激素(雄激素)的浓度以及与头皮毛囊中存在的雄激素受体结合的高浓度5α-二氢睾酮(DHT)。DHT通过与头皮真皮乳头中的雄激素受体结合来调节毛发生长,DHT的结合将细胞破坏信号传递给毛母细胞(keratinocyte cell)的基因,产生细胞凋亡因子DKK-1和TGF-β1,最终破坏毛母细胞而导致脱发(Inui S et al.,JDermatol Sci.,61(1):1-6,2011)。
公知的防脱发剂有FDA批准的皮肤外用的米诺地尔(Minoxidil)、口服用非那雄胺(Finasteride)、韩国MFDS批准的度他雄胺(Dutasteride)。虽然强烈推测米诺地尔会遵循通过细胞膜超极化扩张血管来向毛囊提供营养的机制,但也有研究结果报道,其可以直接作用于人体毛囊细胞,激活β-连环蛋白的信号,这是一种代表性的增殖机制(Kwack MH etal.,J Dermatol Sci.,62(3):154-159,2011)。众所周知,非那雄胺和度他雄胺通过抑制将睾酮转化为DHT的5α-还原酶(5α-Reductase),抑制导致脱发的DHT的产生(Yamana K etal.,Horm Mol Biol Clin Investig.,1;2(3):293-299,2010;Clark RV et al.,J ClinEndocrinol Metab.,89(5):2179-2184,2004)。然而,以前称为脱发治疗剂的化学防脱发剂一旦停用就会失去效果,因此需要持续服用,而且具有各种副作用,例如诱导皮炎、性欲减退和诱发男性乳房发育症等,因此正在持续研究寻找天然防脱发剂。
对于防脱发剂的主要机制,主要研究激活人真皮乳头细胞的增殖及相关信号机制的方法,以及通过抑制如上所述的5α-还原酶来降低DHT产生率的方法。真皮乳头细胞不仅对毛囊的发育和生长重要,而且具有多向分化潜能。毛发的生长主要分为生长期、退化期、休止期和发育期。在生长期,真皮乳头细胞增殖,整个毛发生长(Driskell RR et al.,JCell Sci.,15;124(Pt8):1179-1182,2011)。真皮乳头细胞的增殖涉及多种因素,包括延长生长期的FGF-7、诱导细胞生长的ERK活性、对毛囊发育起到主导作用的β-连环蛋白机制以及抑制细胞凋亡的Akt活性等(Gentile P et al.,Cells.,16;8(5),doi:10.3390/cells8050466,2019)。
奶蓟(milk thistle)为菊科水飞蓟属多年生草本植物,为一年生或二年生草本植物,特征在于叶子上有明显的白色条纹。属名“水飞蓟(Silybum)”源自狄奥斯科里德斯(Dioscorides)给一种类似蓟的植物起的希腊名字,因叶片折断时会流出乳白色乳汁而被称为奶蓟。奶蓟(milk thistle)的肝细胞保护作用最为人所知,韩国专利公开第10-2016-0140417号公开了将奶蓟提取物、后发酵茶提取物和壳寡糖一起使用可起到肝功能改善效果等。众所周知,奶蓟提取物不仅可以改善肝功能,还可以降低总胆固醇和治疗糖尿病,还可以用于预防晕车和心脏病。奶蓟的主要功能是改善肝脏健康,因为从种子提取的成分产生该功效,所以种子以外的部位已作为农作物副产品被丢弃。如果可以研究种子以外的部位的生理活性并将其用作有效成分,则可以通过废弃资源的回收利用有望赋予高附加值。
随着脱发人口的增加和脱发患者年龄的减少,不仅在韩国而且在包括中国、美国和欧洲等的国家,脱发正在成为一个主要的社会问题,因此急需开发能够改善脱发症状的物质。
为从根本上解决因衰老而引起的真皮乳头细胞的失活问题,本发明人为了寻找在对人体的刺激性小的的同时可激活真皮乳头细胞的天然物质而进行了研究,并且为了寻找促进因衰老而减少的真皮乳头细胞的增殖,抑制衰老相关β-半乳糖苷酶(SA-β-Gal)的活性和衰老相关分泌表型的产生,激活真皮乳头细胞的天然物质而进行了研究,结果发现奶蓟各部位提取物中去除种子的奶蓟花提取物具有优异的防脱发剂的功效,从而完成了本发明。
发明内容
发明要解决的技术问题
本发明的目的在于,提供一种用于防止脱发或促进生发的化妆品组合物,其包含奶蓟花提取物作为有效成分。
本发明的再一目的在于,提供一种用于防止脱发或促进生发的药物组合物,其包含奶蓟花提取物作为有效成分。
本发明的另一目的在于,提供一种用于防止脱发或促进生发的食品组合物,其包含奶蓟花提取物作为有效成。
本发明的还有一目的在于,提供一种预防或治疗脱发相关疾病的方法,其包括:给药包含奶蓟花提取物作为有效成分的组合物。
用于解决问题的技术方案
为了实现所述目的,本发明提供一种用于防止脱发或促进生发的化妆品组合物,其包含奶蓟花提取物作为有效成分。
并且,本发明提供一种用于防止脱发或促进生发的药物组合物,其包含奶蓟花提取物作为有效成分。
并且,本发明提供一种用于防止脱发或促进生发的食品组合物,其包含奶蓟花提取物作为有效成分。
并且,本发明提供一种预防或治疗脱发相关疾病的方法,其包括:给药包含奶蓟花提取物作为有效成分的组合物。
发明的效果
本发明的包含奶蓟花提取物作为有效成分的用于防止脱发或促进生发的组合物由于没有皮肤刺激性和细胞毒性而具有优异的人体安全性,促进因衰老而减少的真皮乳头细胞的增殖,并且阻碍衰老相关β-半乳糖苷酶的活性,抑制衰老相关分泌表型来阻碍真皮乳头细胞的衰老,在激活真皮乳头细胞方面非常有效,因此可以有效用作用于防止脱发和促进生发的化妆品组合物、药物组合物或食品组合物的有效成分。
附图说明
图1为本发明的奶蓟各部位提取物对真皮乳头细胞的增殖效果分析图。
图2为本发明的去除种子的奶蓟花提取物对衰老相关β-半乳糖苷酶的活性的抑制效果图。
图3为本发明的去除种子的奶蓟花提取物对衰老相关分泌表型(IL-6和IL-8)产生的抑制效果图。
最佳实施方式
本发明涉及包含奶蓟花提取物作为有效成分的用于防止脱发或促进生发的组合物及其用途。具体地涉及包含奶蓟花提取物作为有效成分的化妆品组合物、药物组合物以及食品组合物,所述组合物由于没有皮肤刺激性和细胞毒性而具有优异的人体安全性,促进因衰老而减少的真皮乳头细胞的增殖,阻碍衰老相关β-半乳糖苷酶的活性,抑制衰老相关分泌表型(IL-6和IL-8)的产生,通过阻碍真皮乳头细胞的衰老来激活真皮乳头细胞,可以有效防止脱发并促进生发。
根据一方面,本发明提供一种用于防止脱发或促进生发的组合物,其包含奶蓟花提取物作为有效成分。
本发明的术语“奶蓟(milk thistle)”为菊科水飞蓟属多年生草本植物,包括水飞蓟(Silybum marianum)和象牙蓟(Silybum eburneum)。水飞蓟(Silybum marianum)意为神圣的奶蓟(blessed milk thistle),遍布欧洲、亚洲、北非、中国和澳大利亚等地区。象牙蓟(Silybum eburneum)也被称为银奶蓟(silver milk thistle)或象蓟(elephantthistle),阿尔及利亚、摩洛哥和西班牙等是主要原产地。奶蓟的各部分均可食用,主要利用叶、茎、根和种子。
本发明的术语“奶蓟花”是指含有或不含奶蓟种子(seed)的花,优选是指从奶蓟的花去除种子(seed)后的剩余部分。
本发明的术语“提取物(extract)”是指将目标物质浸渍在各种溶剂中,然后在常温或加热状态下提取、分馏一定时间后获得的液体成分,以及从所述液体成分去除溶剂而获得的固体成分等产物。另外,除所述产物之外,可综合理解为还包含所述产物的稀释液、其浓缩液、其粗提纯品、提纯品等。
所述奶蓟花提取物可以用水或各种有机溶剂等提取获得。此时,所使用的有机溶剂只要能够获得具有防止脱发或促进生发效果的提取物即可,没有特别限定,优选地可以为水、极性溶剂或非极性溶剂,更优选地可以为水、碳原子数为1~4的低级醇(乙醇、甲醇、丙醇或丁醇等)及其混合溶剂等,最优选地可以为乙醇。
并且,所述提取物的获得方法只要能够获得具有防止脱发或促进生发效果的提取物即可,没有特别限定。提取方法包括冷浸提取、超声波提取或回流冷却提取法等,优选实施超声波提取法。
所述超声波提取是在常温下利用物理力而不是化学力,利用频率为每秒20000次以上的振动元件从各种天然物质中提取有用成分的方法,与溶剂提取、植物油提取或水蒸气蒸馏提取不同,具有在常温下不破坏天然物质中所含有效成分的前提下以高浓度提取的优点。
作为一个具体实例,所述超声波提取可以对奶蓟花干粉使用60%至80%的乙醇溶液在常温下进行24小时至72小时。优选地,使用65%至75%的乙醇溶液在常温下进行36小时至60小时,更优选地,使用70%的乙醇溶液在常温下进行48小时。如果超出所述数值的下限,则奶蓟花中所含的本发明的有效成分无法充分提取,如果超过上限,则有效成分的提取量没有显著差异,并且有效成分以外的杂质会被提取而工艺效率下降。
可以使用真空减压浓缩器或真空旋转蒸发器对所获得的所述奶蓟花提取物进行减压浓缩,但不限于此。并且,在减压浓缩后,可以通过冷冻干燥、减压干燥、真空干燥、沸腾干燥或喷雾干燥来干燥,但不限于此。
本发明中“脱发”是指在正常有毛发的部位没有毛发的状态,具体是指头皮的末端毛发(浓密的黑色头发)脱落。脱发的原因不限,例如雄激素源性脱发(秃头)、斑秃、真菌感染引起的头部白癣、休止期脱发、拔毛癖、生发障碍等,引起疤痕的疤痕性脱发可以是指狼疮引起的脱发、秃发性毛囊炎、毛发扁平苔藓、烧伤、外伤导致的脱发。
本发明的术语“防止”是指阻止某一事件或现象的发生,在本发明中,防止脱发是指阻止脱发的发生。
本发明中“生发”是指毛囊中长出毛发。所述毛发包括头部的毛根和毛囊、头发、睫毛、眉毛、胡须、腋毛、阴毛,以及全身有毛根和毛囊的部位。
本发明中“促进”是指某一事件或现象的发生与发生前相比增加0.5%以上,优选1%以上,本发明中的促进生发是指生发与现象发生前相比增加0.5%以上。
在本发明中,所述防止脱发或促进生发效果可以通过促进因衰老而减少的真皮乳头细胞的增殖,抑制衰老相关β-半乳糖苷酶(SA-β-Gal)的活性和衰老相关分泌表型的产生,从而阻碍真皮乳头细胞的衰老,激活真皮乳头细胞来实现,所述效果可以通过奶蓟花提取物,尤其从奶蓟花去除种子后剩余的花部分来实现。
根据本发明的一实施例,为了确认奶蓟花提取物的防止脱发或促进生发效果,分析了真皮乳头细胞的增殖效果,对衰老相关β-半乳糖苷酶的活性的阻碍效果和抑制衰老相关分泌表型的产生程度,结果确认到,奶蓟花提取物,即从奶蓟花去除种子后剩余的花的提取物与其他奶蓟花提取物相比显著促进真皮乳头细胞的增殖,对衰老相关β-半乳糖苷酶的活性浓度依赖性地表现出优异的阻碍能力,有效抑制衰老相关分泌表型的产生(参照图1至图3)。
如上所述,本发明提供的奶蓟花提取物通过诱导因衰老而减少的真皮乳头细胞的增殖来产生促进生发效果,具有抑制作为脱发的原因之一的真皮乳头细胞的衰老的效果。并且,本发明提供的奶蓟花提取物可以通过抑制衰老相关β-半乳糖苷酶的活性并阻碍衰老相关分泌表型(IL-6和IL-8)的产生来防止脱发。因此,本发明的奶蓟花提取物可以有效用作用于防止脱发和促进生发的化妆品组合物、药物组合物或食品组合物的有效成分。
所述组合物中所含的奶蓟花提取物的含量没有特别限制,但相对于组合物的总重量,可以为0.00001至100重量百分比,优选为0.0001至30重量百分比,更优选为0.001至20重量百分比,进而优选为0.001至10重量百分比。若所述组合物中奶蓟花提取物的含量小于0.0001重量百分比,则存在功效较弱的缺点。并且,超过15重量百分比时,含量增加带来的效果增加不显著,而且可能发生不能确保化妆品、医药品、食品的剂型上的稳定性的问题。
在一个具体的实施方式中,本发明的包含奶蓟花提取物的用于防止脱发或促进生发的组合物作为用于防止脱发或促进生发的化妆品组合物提供。
在本发明中,所述“化妆品组合物”可以选自由生发液(hair tonic)、发乳(haircream)、头发洗剂(hair lotion)、洗发素(hair shampoo)、护发素(hair rinse)、润发液(hair conditioner)、发胶(hair spray)、毛发用气雾剂(hair aerosol)、润发油(Pomade)、粉末、凝胶(gel)、溶胶-凝胶(sol-gel)、乳剂(emulsion)、油剂(oil)、发蜡(wax)以及气雾剂(aerosol)组成的毛发用化妆品。
所述化妆品组合物可以包含化妆品组合物领域常用的稳定剂、增溶剂、维生素、颜料和香料等常规辅料,或化妆品可接受的载体。
根据需要,所述化妆品组合物还可包含保湿剂、抗炎剂、抗菌剂、抗真菌剂、维生素、防紫外线剂、抗生素、香料和染料。
具体地,所述化妆品组合物可以配制成常规制备的任何剂型,例如溶液、乳剂、混悬剂、糊剂、霜剂、洗剂、凝胶剂、粉剂、喷雾剂、含表面活性剂的洁面剂、油剂、肥皂、液体清洁剂、入浴剂、粉底、隔离霜、精华、化妆水、泡沫、面膜、柔肤水、防晒霜或防晒油等,但不限于此。
在本发明的剂型为溶液或乳剂的情况下,作为载体成分可以使用溶剂、增溶剂或乳化剂,例如水、乙醇、异丙醇、碳酸乙酯、乙酸乙酯、苯甲醇、苯甲酸苄酯、丙二醇、1,3-丁二醇油、甘油脂肪酸酯、聚乙二醇或失水山梨醇脂肪酸酯。
在本发明的剂型为混悬剂的情况下,作为载体成分可以使用如水、乙醇或丙二醇的液体稀释剂;如乙氧基化异硬脂醇、聚氧乙烯山梨糖醇酯和聚氧乙烯失水山梨糖醇酯的助悬剂;微晶纤维素、偏氢氧化铝、膨润土或黄芪胶等。
在本发明的剂型为糊剂、霜剂或凝胶剂的情况下,作为载体成分可以使用动物油、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、滑石粉或氧化锌等。
在本发明的剂型为粉剂或喷雾剂的情况下,作为载体成分可以使用乳糖、滑石粉、二氧化硅、氢氧化铝、硅酸钙或聚酰胺粉末,尤其在喷雾剂的情况下,还可包含如氯氟烃、丙烷/丁烷或二甲醚的推进剂。
在本发明的剂型为含表面活性剂的洁面剂的情况下,作为载体成分可以使用脂肪醇硫酸盐、脂肪醇醚硫酸盐、磺基琥珀酸单酯、羟乙基磺酸盐、咪唑啉鎓衍生物、牛磺酸甲酯、肌氨酸盐、脂肪酸酰胺醚硫酸盐、烷基氨基甜菜碱、脂肪醇、脂肪酸甘油酯、脂肪酸二乙醇酰胺、植物油、羊毛脂衍生物或乙氧基化甘油脂肪酸酯等。
所述载体可以为非天然存在的载体(non-naturally occuring carrier)。
在另一具体的实施方式中,本发明的包含奶蓟花提取物的用于防止脱发或促进生发的组合物作为用于防止脱发或促进生发的药物组合物提供。
本发明的术语“药物组合物”是指以预防或治疗疾病为目的而制备的,并且可以根据常规方法以各种形式配制和使用。例如,可以配制成散剂、颗粒剂、片剂、胶囊剂、混悬剂、乳剂、糖浆剂、气雾剂等口服剂型,可以使用润滑剂、润湿剂、调味剂、乳化剂、助悬剂、防腐剂和表面活性剂等稀释剂或赋形剂以肠胃外剂型配制和使用。并且,还可以以外用剂、栓剂、皮肤外用剂、无菌注射液等形式配制和使用。具体地,本发明的组合物可以通过直接涂抹或散布在毛发或头皮等方法使用。应用本发明的组合物的毛发包括头部的毛根和毛囊、头发、睫毛、眉毛、胡须、腋毛、阴毛,以及全身有毛根和毛囊的部位。
并且,根据各个剂型,可以进一步包含药学上可接受的载体,例如缓冲剂、镇痛剂、增溶剂、等渗剂、稳定剂和基质等本领域公知的载体来制备。本发明中所使用的术语“药学上可接受的载体”可以是指不刺激生物体的同时不阻碍待注射的有效成分的生物活性和特性的载体或稀释剂。本发明中可以使用的所述载体的类型没有特别限制,可以使用本领域常用的和药学上可接受的任何载体。所述载体的非限制性实例包括盐水、无菌水、林格氏溶液、缓冲盐水、白蛋白注射液、葡萄糖溶液、麦芽糊精溶液、甘油、乙醇等。这些可以单独使用或两种以上组合使用。所述载体可以是非天然存在的载体(non-naturally occuringcarrier)。
本发明的组合物可以以药理有效量给药。所述药理有效量是指在能够适用于医学治疗的合理的获益/风险比下足以治疗疾病且不引起副作用的量。有效剂量水平可根据包括患者的健康状况、疾病的类型、严重程度、药物的活性、对药物的敏感性、给药方法、给药时间、给药途径和排泄率,治疗持续时间、联合或同时使用的药物等的因素以及其他医学领域公知的因素来确定。具体地,一般为每天每1kg给药对象体重0.01mg~5000mg,根据医生或药剂师的判断,可每天1次或分几次以规定时间间隔给药,但不限于此。
并且,本发明的药物组合物可以单独使用或与其他具有预防或改善脱发相关疾病效果的药物活性化合物结合来以合适的组合形式组合使用。
本发明的药物组合物可以作为单独的治疗剂给药或与其他治疗剂联合给药,并且可以与常规治疗剂顺序或同时给药。它可以单剂量或多剂量给药。考虑到所有所述因素,重要的是施用能够以最小量获得最大效果而不引起副作用的量,并且本领域技术人员可以容易地确定。
作为一例,除本发明的包含奶蓟花提取物作为有效成分的药物组合物之外,还可以进一步选择给药米诺地尔(minoxidil)、非那雄胺(finasteride)或螺内酯(spironolactone)等传统的脱发治疗剂,但不限于此。
本发明的术语“给药”是指通过任何合适的方法将本发明的药物组合物引入对象,并且本发明的组合物的给药途径只要能够达到目标组织,可以使用口服或肠胃外途径等各种途径。
根据本发明的药物组合物的给药方式没有特别限制,可以按照本领域常用的方式进行。作为给药方式的非限制性实例,组合物可以通过口服给药或肠胃外给药来给药。具体地,本发明的组合物可以通过直接涂抹或散布在毛发或头皮等方法使用。
根据所需的给药方式,根据本发明的药物组合物可以制备成各种剂型。
本发明的组合物的给药频率没有特别限制,可以一天给药一次,也可以将剂量分次并给药数次。
在另一具体的实施方式中,本发明的包含奶蓟花提取物的用于防止脱发或促进生发的组合物作为用于防止脱发或促进生发的食品组合物提供。
将本发明的组合物用作食品添加剂时,所述奶蓟花提取物可以直接添加或与其他食品或食品成分一起使用,并且可以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(预防、保健或治疗处理)适当确定,还可以包含食品学上可接受的食品辅助添加剂。由于本发明的组合物使用源自天然物质的提取物作为有效成分,因此在稳定性方面没有问题,对混合量没有很大限制。
本发明的食品组合物可以包含所有常规意义上的食品,并且可以与如功能性食品和保健功能性食品等本领域已知的术语互换使用。
本发明的术语“功能性食品”指采用对人体具有有益功能的原料或成分制备或加工而成的食品,“功能性”是指对人体结构和功能调节营养素或获得生理作用等对健康有益的效果而摄入。
并且,本发明的术语“功能性保健食品”是指以保健为目的,以特定成分为原料,或者对食品成分中含有的特定成分进行提取、浓缩、提纯、混合等方法制备、加工而成的食品,也是指由所述成分设计加工而成且可充分发挥生物防御、调节生物节律、防止和恢复疾病等生物调节功能的食品,所述保健食品用组合物可以发挥与疾病的预防和恢复等相关的功能。
用于预防脱发或促进生发的本发明的组合物可适用的食品的类型没有限制。并且,本发明的包含奶蓟花提取物作为有效成分的组合物可以根据本领域技术人员的选择,通过混合适当的可能包含在食品中的其他辅助成分和公知的添加剂来制备。可以添加的食品的例子包括肉、香肠、面包、巧克力、糖果、零食、饼干、比萨、拉面、其他面条、口香糖、包括冰淇淋的乳制品、各种汤、饮料、茶、饮剂、酒精饮料、维生素复合剂等,可以添加到将本发明的提取物及其分馏物作为主要成分来制备的果汁、茶、果冻、果汁等。
并且,本发明中可以适用的食品包括例如特殊营养食品(例:配方奶、婴幼儿食品等)、加工肉制品、鱼肉制品、豆腐、凉粉、面条(例:拉面、面条等)、保健食品、调味料(例:酱油、大酱、辣椒酱、混合酱等)、酱料、饼干(例:零食)、乳制品(例:发酵乳、奶酪等)、其他加工食品、泡菜、腌制食品(各类泡菜、腌菜等)、饮料(例:水果、蔬菜饮料、豆浆、发酵饮料等)、天然调味料(例:拉面调料等)等所有食品。
当本发明的功能性保健食品组合物以饮料的形式使用时,可以包含各种甜味剂、调味剂或天然碳水化合物等作为附加成分,如同常规饮料。除了所述成分之外,本发明的功能性保健食品组合物还可含有各种营养素、维生素、电解质、风味剂、着色剂、果胶酸及其盐、海藻酸及其盐、有机酸、保护性胶体增稠剂、pH调节剂、稳定剂、防腐剂、甘油、酒精、碳酸饮料中使用的碳酸化剂等。此外,还可含有用于制备天然果汁、果汁饮料和蔬菜饮料的果肉。
本发明的奶蓟花提取物,更具体地奶蓟花乙醇提取物以天然药用植物为原料制成,因此即使用作化妆品组合物、药物组合物或食品组合物,出现的副作用低于一般合成化合物,可以安全地包含在内并且有效使用。
根据本发明的另一方面,本发明提供一种预防或治疗脱发相关疾病的方法,其包括:给药包含奶蓟花提取物的组合物。
本发明中所使用的术语“对象”可以是指患有或可能患有脱发相关疾病的所有动物,包括人类。所述动物不仅可以是人,还可以是因类似症状需要治疗的哺乳动物,如牛、马、绵羊、猪、山羊、骆驼、羚羊、狗和猫等,但不限于此。
具体地,本发明的所述预防或治疗方法包括:向患有或可能患有脱发相关疾病的对象施用药理有效量的所述组合物。给药方法如上所述。
所述预防可以是指通过向对象施用根据本发明的用于防止脱发或促进生发的组合物来抑制或延迟脱发相关疾病的发作的任何行为。
并且,所述治疗可以是指通过向疑似患有脱发相关疾病的对象施用本发明的所述组合物来改善或有益于脱发相关疾病的症状的任何作用。
包含奶蓟花提取物的所述组合物如上所述。
除了所述有效成分之外,本发明的组合物还可包含药学上可接受的载体、赋形剂或稀释剂,以便给药。所述载体、赋形剂和稀释剂可以包括乳糖、葡萄糖、蔗糖、山梨糖醇、甘露糖醇、淀粉、阿拉伯树胶、藻酸盐、明胶、硅酸钙、微晶纤维素、聚乙烯吡咯烷酮、纤维素、水、糖浆、甲基纤维素、羟基苯甲酸甲酯、羟基苯甲酸丙酯、滑石、硬脂酸镁和矿物油。
本发明的组合物的适当剂量根据患者的状况和体重、疾病的严重程度、药物的类型和时间而变化,可以由本领域技术人员适当地选择。具体地,所述奶蓟花提取物的剂量可以为50~500mg/Kg。
所述脱发相关疾病可以包括斑秃(Alopecia Areata)、雄激素源性脱发(Androgenetic Alopecia)、休止期脱发(Telogen Effluvium)、外伤性脱发、拔毛癖(Trichoti lomania)、压迫性脱发(Pressure Alopecia)等生长期脱发、头皮屑脱发、梅毒性脱发(Alopecia syphlltiac)、脂溢性脱发(Alopecia seborrhecia)、症状性脱发、疤痕性脱发、先天性脱发等,但不限于此,可以是指毛发从毛囊脱落导致的所有疾病。
具体实施方式
以下,将详细描述实施例等以帮助理解本发明。然而,可以以许多不同的形式修改根据本发明的实施例,并且本发明的范围不应被解释为限于以下实施例。提供本发明的实施例是为了向本领域的普通技术人员更完整地解释本发明。
实施例1:奶蓟各部位提取物的制备
从花、地上叶茎和根采集各部位的奶蓟(Silybum marianum)。在花的情况下,以去除种子的花和未去除种子的花的形式分离并制备。将采集的部位清洗干净,彻底去除异物和杂质后,在20℃至35℃的阴凉处干燥,然后粉碎至1mm以下的粒径。然后,将粉碎的奶蓟各部位的粉末100g浸入70%的乙醇溶剂中,超声波提取48小时,并将所获得的提取液使用滤纸(Advantec,No.2)过滤。将过滤产物减压浓缩,制备奶蓟各部位提取物。
实施例2:复制性衰老细胞的制备
为了诱导复制性衰老,人真皮乳头细胞HFDPC(Hair follicle dermal papillacell,PromoCell)购自PromoCell(德国海德堡)。在含有supplementMix的真皮乳头细胞生长培养基中培养人真皮乳头细胞后,以4×105细胞数量接种到100mm培养皿,在5%浓度的CO2培养箱中以37℃条件培养。当细胞在培养皿生长至80~90%左右时,用胰蛋白酶-EDTA处理以去除细胞,测定细胞数量,根据以下数学式1测定细胞群体倍增时间(DT),以确认细胞生长程度。通过如上所述的过程连续传代培养细胞,并诱导复制性衰老。年轻真皮乳头细胞的DT为1.5天,复制性衰老真皮乳头细胞的DT为10.9天。通过衰老相关β-半乳糖苷酶染色或通过ELISA检测IL-6和IL-8的衰老相关分泌表型(SASP)来确认细胞衰老程度。
[数学式1]
DT=(T-T0)/3.32×(logN-logN0)
(N=培养皿中生长的细胞数量,N0=首次接种的细胞数量,T-T0=细胞培养天数)
实施例3:体外(in vitro)测定根据提取部位的奶蓟花提取物对真皮乳头细胞的增殖效果
为了确认奶蓟花提取物根据提取部位对毛发生长的主要细胞——真皮乳头细胞的增殖有何影响,测定了真皮乳头细胞的增殖能力。具体地,在含有supplementMix的真皮乳头细胞生长培养基中培养人真皮乳头细胞HFDPC(Hair follicle dermal papillacell,PromoCell),然后接种到24孔板(1.5×104个细胞/孔)中,在5%浓度的CO2培养箱中以37℃条件培养24小时。将奶蓟各部位提取物溶解在培养基中后,在培养的各孔中进行处理,再次培养72小时。72小时后,去除细胞培养上清液,将MTT试剂以1mg/ml溶解,稀释10倍,然后与培养基混合,处理,培养2小时。2小时后,去除MTT试剂后,每孔加入二甲基亚砜(DMSO)200μl,溶解甲臜(formazan),在540nm处测定吸光度,数值见图1。
如图1所示,当处理去除种子的奶蓟花提取物时,与年轻细胞相比在复制性衰老细胞中减少的真皮乳头细胞的增殖能力与对照组相比呈浓度依赖性增加,而在其他部位提取物中未出现明显的细胞增殖的促进效果。并且,确认到与包含种子的花提取物相比,去除种子的花提取物更能促进细胞的增殖。
实施例4:体外(in vitro)测定去除种子的奶蓟花提取物对衰老相关β-半乳糖苷酶的活性的阻碍效果
将真皮乳头细胞接种到6孔板(2×105细胞/孔),在5%浓度的CO2培养箱中以37℃条件培养24小时。将去除种子的奶蓟花提取物溶解于培养基中后,该去除种子的奶蓟花提取物是在所述实施例3的结果中被确认为能够显著增加与年轻细胞相比在复制性衰老细胞中减少的真皮乳头细胞的增殖能力的,在培养的各孔中进行处理,再次培养72小时。72小时后,去除细胞培养上清液,用胰蛋白酶-EDTA处理以去除细胞,然后用SPiDER-βGal(日本同仁堂)荧光染色细胞15分钟,用流式细胞仪(flow cytometry,FACS Calibur,碧迪医疗(Becton Dickinson),加拿大圣何塞)对细胞进行计数。通过确认表现出衰老相关β-半乳糖苷酶的活性的细胞的比例,观察细胞衰老的变化。
所得数值以对照组为100%进行换算,结果如图2所示。
如图2所示,与复制性衰老细胞相比,去除种子的奶蓟花提取物以浓度依赖性地表现出优异的衰老相关β-半乳糖苷酶的活性的阻碍能力。
实施例5:体外(in vitro)测定去除种子的奶蓟花提取物对衰老相关分泌表型的产生抑制效果
将真皮乳头细胞接种到6孔板(2×105细胞/孔),在5%浓度的CO2培养箱中以37℃条件培养24小时。将去除种子的奶蓟花提取物溶解于培养基中后,在培养的各孔中进行处理,再次培养72小时。72小时后,收集细胞培养上清液,用Human IL-6Quantikine ELISAKit或IL-8/CXCL8 ELISAKit(R&D systems,美国)确认细胞培养液中衰老相关分泌表型IL-6和IL-8浓度。结果如图3所示。
如图3所示,与未处理组相比,去除种子的奶蓟花提取物在年轻细胞和复制性衰老细胞均表现出IL-6和IL-8减少的结果。由此确认到去除种子的奶蓟花提取物通过抑制衰老相关分泌表型的产生,激活真皮乳头细胞。
实施例6:去除种子的奶蓟花提取物对人体皮肤的安全性的确认试验
为了确认根据本发明的去除种子的奶蓟花提取物对人体皮肤是否安全,进行了皮肤安全性确认实验。为此,进行了皮肤累积刺激试验。
制备分别含有0.1%、0.5%和1%的实施例1的去除种子的奶蓟花提取物的营养霜。具体地,将作为水相的纯化水、三乙醇胺和丙二醇加热至70℃溶解,然后加入将蜂蜡、液体石蜡、油相成分、乳化剂和防腐剂加热至70℃溶解而成的溶液进行乳化。乳化结束后,将所述溶液冷却至45℃,分别加入0.1%、0.5%、1%的去除种子的奶蓟花提取物,分散,然后冷却至30℃。随着所述去除种子的奶蓟花提取物的含量增加至0.1%、0.5%和1%,液体石蜡的含量分别降低至9.91%、9.51%和9.01%,由此制备营养膏。
使用以如上所述方式制备的营养霜,将30名健康成年人作为对象,每隔一天在上臂部位进行24小时的累积斑贴,共进行9次,以测定去除种子的奶蓟花提取物是否刺激皮肤。
斑贴试验方法使用斑试器(Finn chamber,Epitest Ltd,芬兰)。将15μl的各所述皮肤外用剂滴入斑试器中,然后进行斑贴试验。使用以下[数学式2]对每次在皮肤中显示的反应程度进行评分,结果示于下表1中。
[数学式2]
平均反应度=[[(反应指数×反应度)/(受试者总数×最高分数(4分))]×100]÷试验次数(9次)
在反应度中,±记1分,+记2分,++记4分,当平均反应度小于3时,判断为安全的组合物。
表1
如所述表1所示,试验组1、2、3中±、+、++对应的人数均为0,平均反应度也为0.00。所述试验结果显示平均反应度为3以下,因此根据本发明的去除种子的奶蓟花提取物没有显示出明显的累积刺激样态,判断为对人体皮肤是安全的物质。
本发明的组合物可以制备为如下制剂例,但不限于此。
制剂例1:化妆品制剂
制剂例1-1:柔肤水
如下表2所示,根据常规方法制备包含奶蓟花提取物作为有效成分的柔肤水。
表2
成分 | 重量百分比 |
奶蓟花提取物 | 0.01 |
甘油 | 3.0 |
丁二醇 | 2.0 |
丙二醇 | 2.0 |
羧乙烯聚合物 | 0.1 |
乙醇 | 10.0 |
三乙醇胺 | 0.1 |
防腐剂、微量色素、微量香料和微量纯化水 | 82.79 |
总计 | 100.0 |
制剂例1-2:营养化妆水
如下表3所示,根据常规方法制备包含奶蓟花提取物作为有效成分的营养化妆水。
表3
制剂例1-3:营养霜
如下表4所示,根据常规方法制备包含奶蓟花提取物作为有效成分的营养霜。
表4
成分 | 重量百分比 |
奶蓟花提取物 | 0.01 |
蜂蜡 | 10.0 |
聚山梨酯60 | 1.5 |
失水山梨糖醇倍半油酸酯 | 0.5 |
液体石蜡 | 10.0 |
角鲨烷 | 5.0 |
辛酸/癸酸甘油三酯 | 5.0 |
甘油 | 5.0 |
丁二醇 | 3.0 |
丙二醇 | 3.0 |
三乙醇胺 | 0.2 |
防腐剂、微量色素、微量香料和微量纯化水 | 56.79 |
总计 | 100.0 |
制剂例1-4:按摩霜
如下表5所示,根据常规方法制备包含奶蓟花提取物作为有效成分的按摩霜。
表5
成分 | 重量百分比 |
奶蓟花提取物 | 0.01 |
蜂蜡 | 10.0 |
聚山梨酯60 | 1.5 |
失水山梨糖醇倍半油酸酯 | 0.8 |
液体石蜡 | 40.0 |
角鲨烷 | 5.0 |
辛酸/癸酸甘油三酯 | 4.0 |
甘油 | 5.0 |
丁二醇 | 3.0 |
丙二醇 | 3.0 |
三乙醇胺 | 0.2 |
防腐剂、微量色素、微量香料和微量纯化水 | 27.49 |
总计 | 100.0 |
制剂例1-5:面膜
如下表6所示,根据常规方法制备包含奶蓟花提取物作为有效成分的面膜。
表6
制剂例2:药物制剂
制剂例2-1:散剂的制备
表7
成分 | 含量(g) |
奶蓟花提取物 | 2 |
乳糖 | 1 |
将所述成分混合并装入密封袋中,以制备散剂。
制剂例2-2:片剂的制备
表8
成分 | 含量(mg) |
奶蓟花提取物 | 100 |
玉米淀粉 | 100 |
乳糖 | 100 |
硬脂酸镁 | 2 |
将所述成分混合并根据常规的片剂制备方法压片,以制备片剂。
制剂例2-3:胶囊剂的制备
表9
将所述成分混合并根据常规的胶囊剂制备方法填充至明胶胶囊,以制备胶囊剂。
制剂例2-4:凝胶的制备
表10
成分 | 重量百分比 |
奶蓟花提取物 | 1.00 |
丁二醇 | 2.00 |
甘油 | 1.00 |
EDTA二钠盐 | 0.02 |
PEG-60氢化蓖麻油 | 1.00 |
椰油酰胺丙基甜菜碱 | 4.00 |
月桂基葡糖苷 | 6.00 |
聚山梨酯20 | 1.00 |
苯甲酸钠 | 0.40 |
辛二醇 | 0.20 |
乳酸钠 | 0.50 |
羟乙基纤维素 | 0.7 |
纯化水 | 82.18 |
总计 | 100.0 |
将所述成分混合并根据常规方法制备包含奶蓟花提取物作为有效成分的凝胶。
制剂例2-5:软膏剂的制备
表11
成分 | 重量百分比 |
奶蓟花提取物 | 1.0 |
二乙醇胺 | 1.5 |
聚乙烯吡咯烷酮 | 5.0 |
丙二醇 | 30.0 |
纯化水 | 62.5 |
总计 | 100.0 |
Claims (8)
1.一种用于防止脱发或促进生发的化妆品组合物,其中,包含奶蓟花提取物作为有效成分。
2.根据权利要求1所述的用于防止脱发或促进生发的化妆品组合物,其中,所述奶蓟花提取物的提取溶剂为水、C1~C4的低级醇或其混合物。
3.根据权利要求1所述的用于防止脱发或促进生发的化妆品组合物,其中,所述组合物促进因衰老而减少的真皮乳头细胞的增殖,阻碍衰老相关β-半乳糖苷酶的活性,抑制衰老相关分泌表型的产生,从而阻碍真皮乳头细胞的衰老,最终激活真皮乳头细胞。
4.根据权利要求1所述的用于防止脱发或促进生发的化妆品组合物,其中,所述化妆品组合物选自由生发液、发乳、头发洗剂、洗发素、护发素、润发液、发胶、毛发用气雾剂、润发油、粉末、凝胶、溶胶-凝胶、乳剂、油剂、发蜡和气雾剂组成的毛发用化妆品。
5.一种用于防止脱发或促进生发的药物组合物,其中,包含奶蓟花提取物作为有效成分。
6.一种用于防止脱发或促进生发的食品组合物,其中,包含奶蓟花提取物作为有效成分。
7.一种预防或治疗脱发相关疾病的方法,其中,包括:给药包含奶蓟花提取物作为有效成分的组合物。
8.根据权利要求7所述的预防或治疗脱发相关疾病的方法,其中,所述脱发相关疾病是斑秃、雄激素源性脱发、休止期脱发、生长期脱发、头皮屑脱发、梅毒性脱发、脂溢性脱发、症状性脱发、疤痕性脱发或先天性脱发。
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CN202280005317.7A Pending CN116249514A (zh) | 2021-08-18 | 2022-08-18 | 包含奶蓟花提取物作为有效成分的用于防止脱发或促进生发的组合物 |
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US (1) | US20240115642A1 (zh) |
KR (1) | KR102386120B1 (zh) |
CN (1) | CN116249514A (zh) |
WO (1) | WO2023022540A1 (zh) |
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KR102386120B1 (ko) * | 2021-08-18 | 2022-04-14 | 바이오스펙트럼 주식회사 | 밀크씨슬 꽃 추출물을 유효성분으로 포함하는 탈모 방지 또는 발모 촉진용 조성물 |
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KR20110004994A (ko) * | 2009-07-09 | 2011-01-17 | 전라남도 | 토종 엉겅퀴로부터 약리활성물질을 추출하는 방법 및 이를 이용한 기능성 제품 |
KR101821942B1 (ko) * | 2010-12-30 | 2018-01-24 | 마리 케이 인코포레이티드 | 다목적 화장품 조성물 |
KR20150141079A (ko) * | 2014-06-09 | 2015-12-17 | (주)엘큐어 | 두피 보호용 화장료 조성물 |
KR101697146B1 (ko) * | 2015-03-27 | 2017-01-17 | 전라남도 | 큰엉겅퀴로부터 실리마린의 고효율 추출하는 방법 |
KR102634131B1 (ko) | 2015-05-29 | 2024-02-07 | (주)아모레퍼시픽 | 천연 추출물을 함유하는 간기능 개선용 조성물 |
KR102142930B1 (ko) | 2018-11-28 | 2020-08-11 | 바이오스펙트럼 주식회사 | 밀크씨슬 꽃 추출물을 유효성분으로 포함하는 멜라닌 생성 촉진용 조성물 |
KR102386120B1 (ko) * | 2021-08-18 | 2022-04-14 | 바이오스펙트럼 주식회사 | 밀크씨슬 꽃 추출물을 유효성분으로 포함하는 탈모 방지 또는 발모 촉진용 조성물 |
-
2021
- 2021-08-18 KR KR1020210108678A patent/KR102386120B1/ko active IP Right Grant
-
2022
- 2022-08-18 US US18/013,343 patent/US20240115642A1/en active Pending
- 2022-08-18 WO PCT/KR2022/012362 patent/WO2023022540A1/ko unknown
- 2022-08-18 CN CN202280005317.7A patent/CN116249514A/zh active Pending
Also Published As
Publication number | Publication date |
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WO2023022540A1 (ko) | 2023-02-23 |
US20240115642A1 (en) | 2024-04-11 |
KR102386120B1 (ko) | 2022-04-14 |
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