CN111107861B - 昌化鹅耳枥叶的乙醇提取物在制备用于防止脱发的药学组合物中的用途 - Google Patents
昌化鹅耳枥叶的乙醇提取物在制备用于防止脱发的药学组合物中的用途 Download PDFInfo
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- CN111107861B CN111107861B CN201880061001.3A CN201880061001A CN111107861B CN 111107861 B CN111107861 B CN 111107861B CN 201880061001 A CN201880061001 A CN 201880061001A CN 111107861 B CN111107861 B CN 111107861B
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Abstract
本发明涉及包含昌化鹅耳枥叶提取物的防止脱发或毛发生长促进用药学组合物。包含昌化鹅耳枥叶提取物的组合物被认定为具有抑制及预防脱发且促进毛发生长的功效，因此可在药学、化妆品及美容等领域中以多种方式应用。
Description
技术领域
本发明涉及包含从昌化鹅耳枥叶提取的成分的防止脱发或毛发生长促进用组合物。
背景技术
人体的毛发在“毛囊”中形成，其数量约为10万～15万根。毛囊中具有毛乳头，在此部位中分布有小血管，用于供给毛发生长中所需的营养成分，在毛乳头上的旁边具有皮脂腺，用于供给使毛发润泽的油脂。毛囊(hair follicle)由多种不同的皮膜细胞(epithelial cells)及毛乳头细胞(dermal papilla cells，DPCs)形成。毛乳头细胞为位于毛囊的基底部的间充质由来成纤维细胞(mesenchymally-derived fibroblasts)，对毛发生长起到重要的作用。尤其，据报道，米诺地尔(minoxidil)对毛乳头细胞具有增殖及抗细胞凋亡的效果。类似地，其他报告书中提出可通过毛乳头细胞的增殖促进毛发生。毛发分别具有不同的周期，经过生长期(anagen)、退化期(catagen)、休止期(telogen)生长并脱落。这种周期经过3～6年反复进行，正常情况下每日平均脱落50～100根毛发。通常，所谓的脱发症是指在这种周期中，生长期毛发的比率减少，而退化期或休止期毛发增多，从而导致所脱落的毛发的数量非正常地增加。
抗癌化疗的副作用包括白细胞减少、呕吐、腹泻及脱发，其中众所周知，抗癌化疗所致的脱发(chemotherapy induced alopecia)约发生65％(Trueb RM，2010)，并且在因抗癌化疗所致脱发的药物中，5-氟尿嘧啶(5-fluorouracil)作为一种抗代谢物(antimetabolite)，其通过抑制胸苷酸合酶(thymidylate synthase)来诱导DNA合成抑制及细胞凋亡(Longley DB et al.,2003)。
像这样，尽管一直以来进行着有关脱发的诸多研究，但对于根本性的有关脱发的机制尚不清楚。并且，尽管一直以来还致力于脱发的治疗，但至今为止，美国食品药品管理局(FDA，Food and Drug Administration)(U.S.A)仅认可两种用于治疗脱发的药物(菲那雄胺(finasteride)及米诺地尔(minoxidil))。菲那雄胺作为5α-还原酶 (5α-reductase)，一直以来用于促进男性的雄激素性脱发症(androgenetic alopecia)中的毛发生长。米诺地尔作为抗高血压剂(anti-hypertensive agent)，可通过ATP-敏感性K+-通道开放来促进毛发生长。然而，因无法预测的效果及副作用，药物的效果是有限性和暂时性的。因此，需要可预防脱发并促进毛发生长的疗效更好的新治疗药物。对于至今为止被公知为具有防止脱发且促进毛发生长效果的米诺地尔 (minoxidil)或粘多糖生长素(trichosaccharide)等制剂而言，正在出现缺乏显著疗效及人体稳定性、引发皮肤刺激等副作用，因此当前实际情况为，急需开发一种确保稳定性及疗效的组合物。
昌化鹅耳枥(Carpinus tschonoskii Maxim.var.tschonoskii)是桦木科鹅耳枥属乔木。据报道，昌化鹅耳枥的抗炎及神经保护效果优秀(Koo JE，et al.，2012；Kim MK，et al.，2010)，有关昌化鹅耳枥提取物的现有发明包括包含昌化鹅耳枥叶提取物的皮肤皱纹改善用化妆品组合物(授权号10-0866784)及包含昌化鹅耳枥叶提取物的皮肤美白改善用化妆品组合物(授权号10-0967073)等。但实际情况为，几乎没有有关昌化鹅耳枥的生发及毛发生长功效的研究报告。
为此，本发明人在寻找几乎无毒性且呈现出防止脱发及促进毛发生长效果的天然物质的过程中，确认到昌化鹅耳枥叶提取物的防止脱发及促进毛发生长的效果，从而完成了本发明。
发明内容
技术问题
本发明的目的在于，提供包含昌化鹅耳枥叶提取物作为有效成分的用于防止脱发的药学组合物。
并且，本发明的目的在于，提供包含昌化鹅耳枥叶提取物作为有效成分的用于促进毛发生长的化妆品组合物。
并且，本发明的目的在于，提供包含昌化鹅耳枥叶提取物作为有效成分的用于防止脱发或促进毛发生长的保健食品。
解决问题的方案
本发明提供包含昌化鹅耳枥叶提取物作为有效成分的用于防止脱发的药学组合物。
本发明中所定义的提取物包括可溶于包括纯化水在内的水、碳原子数为1至4 的低级醇或它们的混合溶剂，选自己烷、丁二醇、丙二醇、甘油、乙酸乙酯、醚、氯仿的溶剂，优选为水或甲醇的混合溶剂的提取物。
所谓的昌化鹅耳枥叶提取物，只要是从昌化鹅耳枥叶中通过提取有效成分而获得的，就不做特别限制将它们全部包括在内。例如，可以是将昌化鹅耳枥叶放入水或有机溶剂中并通过静置、搅拌、加压或加热等手段洗脱有效成分而获得的结果物。并且，包括通过对以如上所述的方式获得的液相提取物进行冷冻干燥而获得的冷冻干燥物。
并且，还包括通过粉碎上述冷冻干燥物而获得的粉末。除此之外，只要是通过本技术领域的普通技术人员可用于提取有效成分的手段来提取的，就包括通过任何手段提取的所有提取物，还将提取后经过冷冻干燥等加工的提取物也均包括在内。另外，包括通过加热或常温提取法等从以往传下来的方法或中医书籍或教科书中所记载的常规提取法提取的提取物。
并且，包括通过Stass Otto提取法或各种柱色谱法等获得的部分提取物，上述方法为用于分离特定活性化合物的特殊提取方法。
上述昌化鹅耳枥叶提取物可以不受限制地使用采集的或商购的，作为一例，可以包括将采集之后用水清洗来去除异物后干燥并粉末化来使用。
上述昌化鹅耳枥叶提取物可通过超声波提取法、过滤法及回流提取法等本技术领域的常规提取方法来获得。
优选地，可以是将昌化鹅耳枥叶试样溶解在乙醇中的提取物。
本说明书中“脱发”意味着毛发从头皮脱落的现象或毛发变稀少或变细的状态，所谓“防止脱发”意味着预防且防止如上所述的脱发现象，所谓“促进毛发生长”意味着不仅促进新的毛发的生成，还使以往毛发健康生长。
通常，“毛发生长”在生长期中形成，通过从休止期向生长期的诱导及从生长期向退行期的延迟来进行促进。毛发周期可分为周知的生长期、退行期及休止期的 3个主要步骤。在生长期中，与细胞的快速增殖一同，通过向皮肤内深处生长来完成毛囊毛发的形成。其次的现象为退行期，上述退行期为细胞分裂的中断脱颖而出的过渡期，在此过程中毛囊逐渐退化，并且毛发生长中断。在作为其次的现象的休止期中，退化毛囊包含具有稠密地充满的毛乳头(dermal papilla)细胞的胚芽(germ)。在休止期中新的生长期现象的开始通过从上述胚芽的快速细胞增殖、毛乳头的膨胀及基底膜要素的合成来进行诱导。
因此，需要生长期的促进或延长来防止毛发的损失，即，引起防止脱发或毛发的再生长，即，需要促进毛发生长，本发明的组合物包含使已存在的毛发不再脱落的效果、使已存在毛发改善成变粗等的效果及生长新的毛发的效果中的一种或以上。毛乳头细胞(dermal papilla cell)作为位于毛囊的基底的中胚层由来成纤维细胞，被认为通过与毛囊的毛基质细胞的相互作用，在毛发的生长中起到重要的作用 (Jahoda CA，et al.，1984；Oliver RF，et al.，1986)。并且，已证明作为2型5α-还原酶(Type 2 5α-reductase)抑制剂的菲那雄胺可通过减少脱发患者的DHT来改善脱发(Van Neste et al.，2000)，这种事实表明5α-还原酶是用于脱发治疗的重要靶点 (target)。因此可知，由于本发明的组合物抑制5α-还原酶并激活毛乳头细胞，因而可以防止脱发并诱导毛发生长。
优选地，上述昌化鹅耳枥叶提取物的浓度为0.001μg/ml至10μg/ml，但不限于此。由于本发明的昌化鹅耳枥叶提取物是从天然物质中提取的，因而几乎无毒性。
在药学组合物中，相对于全部组合物的总重量，可包含0.01重量百分比至70 重量百分比的上述昌化鹅耳枥叶提取物。
本发明的药学组合物可以为口服或非口服的各种剂型。在制剂化的情况下，利用通常使用的填充剂、增量剂、粘合剂、润湿剂、崩解剂、表面活性剂等的稀释剂或赋形剂来进行制备。用于口服给药的固体制剂中包含片剂、丸剂、散剂、颗粒剂、胶囊剂等，这种固体制剂在一种或以上的化合物中混合至少一种的赋形剂，例如，淀粉、碳酸钙、蔗糖(sucrose)或乳糖(lactose)、明胶等来进行制备。并且，除了单纯的赋形剂之外，还使用硬脂酸镁、滑石等的润滑剂。悬浮液、内用液剂、乳剂、糖浆等属于作为用于口服给药的液体制剂，除了作为通常使用的单纯稀释剂的水、液体石蜡之外，可包含多种赋形剂，例如，润湿剂、甜味剂、芳香剂、防腐剂等。用于非口服给药的制剂中包含已灭菌的水溶液、非水溶剂、悬浮液、乳剂、冷冻干燥制剂、栓剂。
作为非水溶剂、悬浮溶剂可使用丙二醇(propyleneglycol)、聚乙二醇、橄榄油等的植物油、油酸乙酯等的可进行注射的酯等。作为栓剂的基质可使用甘油明胶(witepsol)、聚乙二醇、吐温(tween)61、可可油脂、梓、甘油明胶等。
本发明的组合物的药学上的给药形态能够以上述组合物的药学上允许使用的盐的形态使用，并且不仅能够以单独或与其他药学上的活性化合物相结合的形态来使用，还能够以适当的集合来使用。作为上述盐只要是药学上允许使用的，就不做特别限定，可使用例如，盐酸、硫酸、硝酸、磷酸、氢氟酸、氢溴酸、蚁酸、酒石酸、乳酸、柠檬酸、富马酸、马来酸、琥珀酸、甲磺酸、苯磺酸、甲苯磺酸、萘磺酸等。
本发明的组合物可根据所要达到的目的而进行非口服给药或口服给药，可在一日分1至数次来进行给药，使每1kg的体重以0.1mg至500mg的量进行给药。对于特定患者的给药量可根据患者的体重、年龄、性别、健康状态、膳食、给药时间、给药方法、排泄率、疾病的严重程度等来变化。
本发明的药学组合物分别根据常规的方法，包含散剂、颗粒剂、片剂、胶囊剂、悬浮液、乳剂、糖浆、气雾剂等的口服型剂型、软膏、霜剂等的外用剂、栓剂及灭菌注射用液等的适合于药剂学上的制剂的任意形态，都可进行剂型化来使用。
本发明的组合物可通过非口服、口服等的多种方式对大鼠、小鼠、家畜、人类等的哺乳动物给药，可以预料给药的所有方法，例如，可通过口服、直肠或静脉、肌肉、皮下、子宫内硬膜或脑血管内(intracerebroventricular)注射来进行给药。
另一方面，本发明的组合物因不存在太严重的毒性及副作用，当以预防为目的长时间使用时，也可放心使用。
并且，本发明提供包含昌化鹅耳枥叶提取物作为有效成分的用于促进毛发生长的化妆品组合物。
优选地，上述昌化鹅耳枥叶提取物的浓度为0.001μg/ml至10μg/ml，但不限于此。
优选地，上述组合物为选自由生发水、润发乳、护发精华素、头发洗剂、头发营养水、洗发水、护发素、焗油膏、发乳、营养发乳、头发保湿霜、头发按摩霜、发蜡、头发喷雾剂、发膜、营养发膜、洗发皂、洗发奶、发油、毛发干燥剂、毛发防腐处理剂、染发剂、烫发剂、毛发脱色剂、发胶、毛发釉、美发剂、粘发剂、头发保湿剂、摩丝及定发剂组成的组中的剂型，但不限于此。
上述化妆品组合物可包含脂肪物质、有机溶剂、溶剂、增稠剂、胶凝剂、软化剂、抗氧化剂、悬浮剂、稳定化剂、发泡剂(foaming agent)、芳香剂、表面活性剂、水、离子型或非离子型乳化剂、填充剂、多价螯合剂、螯合剂、防腐剂、维生素、阻隔剂、润湿剂、必要的油、染料、颜料、亲水性或疏水性活化剂、脂质囊泡或化妆品中通常使用的任意其他成分等的化妆品学或皮肤科学领域中通常使用的助剂。上述助剂以化妆品学或皮肤科学领域中通常使用的量来导入。
根据上述的化妆品组合物可以为例如化妆品组合物，化妆品组合物的外形包含化妆品学或皮肤科学上允许使用的介质或基质。这作为适合局部应用的所用剂型，能够以例如，溶液、凝胶、固体、捏合无水生成物、在水相中分散油相所取得的乳胶、悬浮液、微乳剂、微囊剂、细颗粒剂或离子型(脂质体)及非离子型的囊泡分散剂的形态或霜剂、化妆水、乳液、散剂、软膏、喷雾剂或遮瑕棒的形态来提供。这些组合物可根据该领域的常规的方法来制备。本发明的组合物还能够以发泡(foam) 的形态或还包含压缩的推进剂的气溶胶组合物的形态来使用。
本发明的化妆品组合物在剂型方面不受特别限制，可剂型化为例如，柔软化妆水、收敛化妆水、营养化妆水、营养霜、按摩霜、精华素、眼霜、眼部精华、洁面乳、洁面泡沫、洁面水、面膜、粉、润肤露、润肤乳、润肤油、美肌精华液等的化妆品。
如上所述的化妆品组合物能够以涂抹于皮肤的形态来利用，还可利用微型针等以向皮肤内部吸收的形态来适用。
并且，本发明的组合物可通过包含适合于涂敷毛发中的载体或载体混合物来制备成毛发组合物。载体包含与溶剂不同的载体或通常用于毛发保护组合物的赋形剂(vehicle)成分，在全部组合物的总重量中以约0.5％至99.5％，优选地，以约5.0％至99.5％，更优选地，以约10.0％至90.0％存在。作为载体，溶剂由共聚物来选择，上述共聚物无关于剂型化的毛发组合物与发胶、摩丝及发根营养液一同使用后残留于毛发或与洗发液、护发素等一同清洗而使用。优选地，在本发明中使用的适当的溶剂包含水、低级醇(乙醇、异丙醇等)、水醇类混合物、烃(异丁烷、己烷、葵烯等)、丙酮、卤代烃(氟利昂等)、烃酯(乙酸乙酯、邻苯二甲酸二丁酯等)、挥发性硅氧烷衍生物、硅氧烷(苯基五甲基二硅氧烷、甲氧基丙基甲基庚环四硅氧烷、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、十甲基环戊硅氧烷等)及它们的混合物。
并且，本发明提供包含昌化鹅耳枥叶提取物作为有效成分的用于防止脱发或促进毛发生长的保健食品。
优选地，上述昌化鹅耳枥叶提取物的浓度为0.001μg/ml至10μg/ml，但不限于此。
优选地，上述保健食品为粉末、颗粒、片剂、胶囊或饮料，但不限于此。
本发明的食品可以按原样添加上述昌化鹅耳枥叶提取物或与其他食品或食品成分一同使用，并且可以根据常规方法适当地使用。
上述食品的种类不受特别限制。可添加上述昌化鹅耳枥叶提取物的食品有例如肉类、香肠、面包、巧克力、糖果类、零食类、饼干类、比萨、拉面、其他面类、口香糖类、包括冰淇淋在内的乳制品、各种汤、饮用水、茶、饮料、酒精饮料及微生物复合剂等，并包括常规意义上的所有食品。
如同普通饮料，本发明的饮料组合物可以包含多种香味剂或天然碳水化合物作为附加成分。上述天然碳水化合物为诸如葡萄糖和果糖之类的单糖、诸如麦芽糖和蔗糖之类的二糖、诸如糊精和环糊精之类的多糖、以及木糖醇、山梨醇和赤藓糖等糖醇。作为甜味剂，可以使用诸如索马甜、甜叶菊提取物之类的天然香味剂或诸如糖精和阿斯巴甜之类的合成香味剂等。上述天然碳水化合物的比例通常为在每 100ml的本发明的组合物中约0.01～0.04g，优选约0.02～0.03g。
除上述之外，本发明的食品可以包含多种营养素、维生素、电解质、风味剂、着色剂、果胶及其盐、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、醇、碳酸饮料中所使用的碳酸化剂等。另外，可以包含用于制备天然果汁、果汁饮料、及蔬菜饮料的果肉。这种成分可以单独或混合使用。这种添加剂的比例不太重要，但通常在每100重量份的本发明的组合物中包含 0.001～0.1重量份的范围内选择。
发明的效果
昌化鹅耳枥叶提取物被认定为通过促进毛发生长中重要的毛乳头细胞的增殖来具有抑制及预防脱发且促进毛发生长的功效，因此可在药学、化妆品及美容等领域中以多种方式应用。
附图说明
图1为确认在不同浓度下昌化鹅耳枥叶提取物的毛乳头细胞(DPCs)增殖促进效果的图。米诺地尔被用作阳性对照组，并且比较了利用昌化鹅耳枥叶提取物(0.01μg/ml、0.1μg/ml及1μg/ml)处理毛乳头细胞的状态。
图2为分离大鼠的生长期触须毛囊(vibrissa follicle)来确认不同浓度下的昌化鹅耳枥叶提取物对毛囊的长度生长产生的影响的图。米诺地尔被用作阳性对照组，并且利用昌化鹅耳枥叶提取物(0.001μg/ml、0.01μg/ml及0.1μg/ml)处理触须毛囊来确认了毛囊的长度生长。
具体实施方式
以下，为了助于理解本发明，例举实施例来进行详细的说明。然而，下述实施例仅为用于例示本发明的内容，本发明的范畴并不由下述实施例而限定。本发明的实施例是为了给本发明所属技术领域中普通技术人员更加完整地说明本发明而提供。
以下所有测量结果以平均±标准偏差或平均±标准误差表示，通过学生t检验(student's t-test)进行统计学显著性检验，当p值(p-value)小于0.05时，认定了显著性。统计处理使用了Sigma Stat统计软件(Sigma Stat software)(Jandel ScientificSoftware，美国)。
实施例1：制备昌化鹅耳枥叶提取物
在从生长在韩国济州岛的昌化鹅耳枥(Carpinus tschonoskii Maxim.var.tschonoskii)采集的叶子的干燥粉末100g中加入1升(liter)的80％EtOH，并在室温下提取24小时。回收上清液，并使用旋转蒸发器(rotary evaporator)进行减压浓缩之后得到20.8g的80％EtOH提取物。该试样由韩国济州生物种类多样性研究所提供(销售号JBRI-10435)。利用50％EtOH(1：1混合PBS：EtOH)溶解所购买的试样并用于实验中。
实施例2：确认昌化鹅耳枥叶提取物的毛乳头细胞(Dermal papilla cell，DPCs)增殖促进效果
将从白鼠胡须中分离的永生化的毛乳头细胞(Rat vibrissa immortalizeddermal papilla cell：Filsell W，et al.，1994)利用包含100units/ml的青霉素(penicillin)-100μg/ml的链霉素(streptomycin)(Gibco Inc，纽约，美国)和10％的热灭活胎牛血清(heat-inactivated fetal bovine serum)(FBS；Gibco Inc，纽约，美国)的DMEM(Hyclone Inc，美国)培养基，在37℃的温度、5％的CO2恒温仪中进行了培养，并且每3天一次进行了继代培养。利用四唑盐比色法(MTT assay)测量了毛乳头细胞(dermalpapilla cell)的增殖。将1.0×104cells/ml的毛乳头细胞(dermal papilla cell)混合于包含1％的FBS的DMEM培养基中，并放入96孔板中，进行24小时培养之后，将3-溴-4，5-二羟基苯甲醛以0.001μM、0.01μM、0.1μM及1μM的浓度进行了处理。作为阳性对照组的米诺地尔(minoxidil)(西格玛公司，密苏里州，美国)以10μM的浓度进行了处理。培养4天之后，放入50μl的MTT(西格玛公司，密苏里州，美国)，进行了4小时的反应。去除上清液，放入200μl的DMSO使沉淀物溶解时候，利用VERSAmax microplate reader(Molecular Devices公司，加利福尼亚州，美国)，在540nm测量了吸光度。求出各个试样组的平均吸光度的值，与对照组的吸光度值相比较来调查了增殖程度。
通过使用毛乳头细胞(dermal papilla cell)来调查昌化鹅耳枥叶提取物是否具有毛发生长功效的结果，当分别以0.01μg/ml、0.1μg/ml及1μg/ml的浓度处理昌化鹅耳枥叶提取物时，相对于对照组，毛乳头细胞(dermal papilla cell)的增殖分别增加了114.6±10.2％(p＜0.05)、119.9±4.7％(p＜0.001)及105.0±9.4％左右(图1)。尤其，在0.1μg/ml的浓度下，相对于作为阳性对照物质使用的10μM米诺地尔的增殖效果 117.4±6.1％(p＜0.01)，昌化鹅耳枥叶提取物呈现出更高的毛乳头细胞增殖功效。该结果表明昌化鹅耳枥叶提取物具有毛发生长功效。
实施例3：确认昌化鹅耳枥叶提取物诱导毛囊生长
从(株)中央实验动物购买出生3个星期的雄性的维斯塔尔大鼠(Wistar rat)(Japan SLC，滨松，日本)，并利用CO2气体进行了安乐死。将大鼠(rat)的左侧和右侧触须垫(mystacial pads)进行分离，放入包含有100units/ml的青霉素 (penicillin)-100μg/ml的链霉素(streptomycin)(Gibco Inc，纽约，美国)的E/P缓冲液 (E/P buffer)[Earle'sbalanced salts solution(EBSS，西格玛公司，密苏里州，美国)+ phosphate-bufferedsaline(PBS，西格玛公司，密苏里州，美国)]。利用解剖显微镜进行观察，小心地对触须毛囊(vibrissa follicles)进行了分离。直到毛囊全部分离，将分离的毛囊放入具有E/P缓冲液的培养皿(Petri dish)中，在37℃的温度、5％的 CO2恒温仪中培养了1小时左右。24孔板(well plate)的各个孔中放入包含2mM的 L-谷氨酰胺(L-glutamine)(Gibco Inc，纽约，美国)、10μg/ml的胰岛素(insulin)(西格玛公司，密苏里州，美国)、50nM的氢化可的松(hydrocortisone)(西格玛公司，密苏里州，美国)及100units/ml的青霉素(penicillin)-100μg/ml的链霉素(streptomycin)的 500μl的William E medium(Gibco Inc，NY，美国)，一个孔(well)中各放入一个毛囊，并在37℃的温度、5％的CO2的恒温仪中进行了培养。培养过程中每3天更换培养基，并且以0.001μg/ml、0.01μg/ml及0.1μg/ml的浓度对昌化鹅耳枥叶提取物进行了处理。将作为阳性对照物质的米诺地尔(minoxidil)以10μM的浓度进行了处理。
培养中的触须毛囊形态利用显微镜(Olympus，日本)进行了拍摄。毛囊长度利用图像分析仪(image analyzer)(DP控制器；Olympus，日本)进行了测量。求出毛囊长度变化的平均值，与对照组的平均长度相比较来测量了生长程度。
对出生3个星期的大鼠的生长期的触须毛囊进行分离，培养3个星期，并测量毛囊长度，从而调查昌化鹅耳枥叶提取物是否具有毛发生长功效。其结果，当在第 21天对昌化鹅耳枥叶提取物处理组和对照组之间的毛囊的长度之差(％)进行比较时，在分别以0.01μM、0.1μM及1μM进行处理的情况下，与对照组相比，毛发纤维(hair fiber)的生长分别增加至149.1±14.2％(P＜0.01)、147.9±17.5％(P＜0.05)及 142.7±19.9％(图2)。尤其，在0.001及0.01μg/ml的浓度下，昌化鹅耳枥叶提取物的毛发纤维(hair fiber)的生长增加效果高于用作阳性对照物质的米诺地(10μM)的 121.9±19.6％生长增加效果。
制剂例1：制备片剂
根据片剂的常规制备方法，将上述多种成分以所提出的含量添加并均匀混合后搅拌，之后颗粒化。干燥后使用压片机制备出了每片含有1mg的昌化鹅耳枥叶提取物作为有效成分的所需的片剂。
制剂例2：制备胶囊剂
根据胶囊剂的常规制备方法，将上述多种成分以所提出的含量添加并均匀混合后，以每个胶囊含有1mg昌化鹅耳枥叶提取物的方式填充于适当大小的明胶胶囊中，从而制备出了所需的胶囊剂。
制剂例3：皮肤外用剂中的软膏
根据软膏的常规制备方法，通过以所提出的含量添加上述多种成分并均匀混合来制备出了软膏。
制剂例4：制备散剂
根据散剂的常规制备方法，通过混合上述多种成分并填充于气密布来制备出了散剂。
制剂例5：制备液剂
根据液剂的常规制备方法，通过混合上述多种成分来制备出了液剂。
制剂例6：制备生发水
根据生发水的常规制备方法，通过混合上述多种成分来制备生发水。
制剂例7：制备润发乳
根据润发乳的常规制备方法，通过混合上述多种成分来制备润发乳。
制剂例8：柔软化妆水(润肤液)
表1
| 配合成分 | 含量(重量百分比) |
| 昌化鹅耳枥叶提取物 | 0.1 |
| 甘油 | 3.0 |
| 丁二醇 | 3.0 |
| 丙二醇 | 3.0 |
| 羧基乙烯聚合物 | 0.1 |
| 蜂蜡 | 4.0 |
| 聚山梨酯60 | 1.5 |
| 辛酸/癸酸甘油三酯 | 5.0 |
| 角鲨烷 | 5.0 |
| 花生四烯酸 | 1.5 |
| 液体石蜡 | 0.5 |
| 鲸蜡硬脂醇 | 1.0 |
| 三乙醇胺 | 0.2 |
| 防腐剂、色素及香料 | 适量 |
| 纯化水 | 剩余量(至100) |
根据上表1中所记载的组成来以常规方法制备出了柔软化妆水。
制剂例9：营养霜
表2
根据上表2中所记载的组成来以常规方法制备出了营养霜。
制剂例10：面膜
表3
根据上表3中所记载的组成来以常规方法制备出了面膜。
Claims (9)
1.昌化鹅耳枥叶的乙醇提取物在制备用于防止脱发的药学组合物中的用途。
2.根据权利要求1所述的用途，其特征在于，上述昌化鹅耳枥叶的乙醇提取物的浓度为0.001μg/ml至10μg/ml。
3.根据权利要求1所述的用途，其特征在于，上述用于防止脱发的药学组合物为选自由片剂、胶囊剂、注射剂、霜剂、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。
4.昌化鹅耳枥叶的乙醇提取物在制备用于防止脱发或促进毛发生长的化妆品组合物中的用途。
5.根据权利要求4所述的用途，其特征在于，上述昌化鹅耳枥叶的乙醇提取物的浓度为0.001μg/ml至10μg/ml。
6.根据权利要求4所述的用途，其特征在于，上述用于防止脱发或促进毛发生长的化妆品组合物为选自由生发水、润发乳、护发精华素、头发洗剂、头发营养水、洗发水、护发素、焗油膏、发乳、头发保湿霜、头发按摩霜、发蜡、头发喷雾剂、发膜、洗发皂、洗发奶、发油、毛发干燥剂、毛发防腐处理剂、染发剂、烫发剂、毛发脱色剂、发胶、毛发釉、美发剂、粘发剂、头发保湿剂、摩丝及定发剂组成的组中的剂型。
7.昌化鹅耳枥叶的乙醇提取物在制备用于防止脱发或促进毛发生长的食品中的用途。
8.根据权利要求7所述的用途，其特征在于，上述昌化鹅耳枥叶的乙醇提取物的浓度为0.001μg/ml至10μg/ml。
9.根据权利要求7所述的用途，其特征在于，上述用于防止脱发或促进毛发生长的食品为粉末、颗粒、片剂、胶囊或饮料。
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