CN105963426A - 含有混合草药的提取物或其加工提取物的用于预防和治疗脱发的组合物及其用途 - Google Patents
含有混合草药的提取物或其加工提取物的用于预防和治疗脱发的组合物及其用途 Download PDFInfo
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Classifications
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- A—HUMAN NECESSITIES
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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Abstract
本发明涉及一种用于预防和治疗脱发并刺激毛发生长活性的组合物,该组合物含有由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物作为活性成分。该创造性的混合提取物与在先发明(例如,韩国专利公开号10‑2014‑0114492(A1)中公开的鱼腥草、紫苏叶和茶叶的发酵提取物)相比表现出更有效的毛发生长促进活性和协同效应,这通过各种动物模型实验(如使用C57BL/6小鼠进行的生长率测试;HFDPC生长的增殖效果等)得以证实,并额外发现该混合提取物比在先发明更有优势,例如,凭借该创造性的提取物的最终形式(即,浓缩固体形式相对于在先发明中公开的溶液类型的最终形式),易于控制规定剂量。
Description
技术领域
本发明涉及含有由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物作为活性成分、显示出刺激毛发生长活性和防止毛发脱落活性的组合物及其用途。
背景技术
毛囊是一个非常复杂的器官,由内毛根鞘(IRS)、外毛根鞘(ORS)、毛干、毛母细胞(Paus et al.,J.Invest.Dermatol.,113,pp523-532,1999)和毛乳头细胞组成,在形成毛囊的各种细胞中,毛乳头细胞在毛发生长中起到重要的作用(Ferraris et al.,Exp.Cell Res.,10,pp37-46,1997)。
毛囊在胚胎发生期间通过间充质细胞和上皮细胞间的相互作用而发育。正常的毛发生长由重复的三个阶段组成,即生长期(anagen)、退行期(catagen)和休止期(telogen)阶段(Paus et al.,N.Engl.J.Med.,341,pp491-497,1999)。特别是,人的头发比起其它动物的毛发或人体的其它部位的毛发而言具有更长的生长时期(生长期,2-5年;退行期,几天-几周;休止期,三个月)。在生长期阶段,组成毛囊的细胞(包括毛乳头周围的基质的角质细胞)增殖并使毛发生长。在退行期阶段,毛囊内细胞凋亡、毛乳头缩合(condensation)和细胞外基质的重建接连发生(Pauset al.,J.Invest.Dermatol.,113,pp523-532,1999),导致细胞分裂停止,延缓毛发的生长。除了包含处于生长静止状态的毛囊隆凸区的长期持久部分,毛囊在休止期阶段脱落,以重新启动新的生长期(Hardy MH.,TrendsGenet.,8,pp55-61,1992)。
已经开发出几种得到美国食品和药物管理局(FDA)批准的促进毛发生长的药物,例如,“米诺地尔”(Buhl et al.,J.Invest.Dermatol.,92(3),pp315-320,1989)和“非那雄胺”(Van Neste et al.,Br.J.Dermatol.,143(4),pp804-810,2000)。
然而,这些药物已经被报道展现若干缺点,例如,使用限制,如仅在特定区域的脱发中有效;不便使用,如长期给药(约6个月到1年),随后局部给药,例如,一天两次,等等;如果长期使用会有各种不良反应,如性欲下降、勃起功能障碍、增加生出先天异常婴儿的风险、瘙痒、过敏(irritation)等(J.Korean Med.Assoc.,Vol.,55(5),pp475-483,2012;J.Ginseng Research,33(3),pp223,2009)。
作为另一种方法,已尝试开发使用具有刺激毛发生长作用的草药提取物的新疗法,例如,在韩国专利公开号10-2014-0114492(A1)中公开的鱼腥草、紫苏叶及茶叶的发酵草药提取物等。
然而,迄今仍需要研发有着更好的活性而无副作用的新药物或物质。
存在许多隶属于五加科(Araliaceae)的人参属植物,例如,分布或栽培于远东亚洲地区的人参(Panax ginseng)、美国和加拿大的西洋参(Panax quinquefolius)、中国的三七(Panax Notoginseng)、北美洲东部地区的三叶人参(Panax trifolia)、越南的越南人参(Panax vietnamensis)、Panax elegatior、狭叶竹节参(Panax wangianus)和羽叶三七(Panaxbipinratifidus)等。
近来,已经进行了很多尝试以通过改变人参的加工方法来提高人参的药理作用,例如,Park等人研发了在特定高温和高压下制备加工人参的新方法,此方法公开于韩国专利登记号192678和美国专利号5776460中,这将主要人参皂苷(如人参皂苷Rb1、Rb2、Rc和Rd)转变成新皂苷(如人参皂苷Rg3、Rg5、Rk1、Rk2、Rk3、Rs1、Rs2、Rs3、F4、Rh2、Rh4和化合物K),显示出新的和更有效的药理作用,如抗氧化活性、抗癌活性和缓解血液循环活性等(Kim WY et al.,J.Nat.Prod.,63(12),pp1702-1704;Kwon SH et al.,J.Chromatogr.A.,921(2),pp335-339,2001)。尤其,已知人参皂苷Rg3、Rg5和Rk1在人参皂苷中显示出最有效的药理活性,例如,神经保护活性、抗痴呆活性、记忆增强活性等(Yang LL etal.,J.Pharm.Pharmacol.,61,pp375-380,2009;Bao H.Y.,et al.,Arch.Pharm.Res.,28(3),pp335-342,2005)。因此,这些新的人参皂苷可以通过Park等人的加工方法(韩国专利登记号192678和美国专利号5776460)在含有达玛烷糖苷的任何人参属植物的根、茎或叶中制造,如人参、西洋参、三七、竹节参(Panax japonica)、三叶人参、Panax pseudoginseng、越南人参、Panax elegatior、狭叶竹节参和羽叶三七。
鱼腥草(完整植株蕺菜(Houttuynia cordata THUNB)属于三白草科(Saururaceae))分布在韩国。据报道,它包含各种成分,例如,癸酰基乙醛、蒎烯、芳樟醇、莰烯、柠檬烯、蕺菜碱、槲皮苷、异槲皮苷等,并显示出各种药效,例如,抗菌活性、抗病毒活性和利尿活性等(B.S.CHUNG et al.Dohaehyangyakdaesajeon,Youngrim Press,pp.812~813,1998)。
紫苏叶(属于唇形科(Labiatae)的Perilla frutescens BRITT.var acutaKUDO或Perilla frutescens BRITT.var crispa DECNE的叶子)分布于韩国。据报道,它包含各种成分,例如,紫苏醛、柠檬烯、精氨酸、枯酸、isogomaketone、紫苏醇等,并用于治疗普通感冒(B.S.CHUNG et al.Dohaehyangyakdaesajeon,Youngrim Press,pp.855~857,1998)。
茶叶(属于山茶科(Theaceae)的茶树(Camellia sinensis O.KTZE)的叶子)分布于包括韩国在内的亚洲国家。据报道,它包含各种成分,例如,咖啡因、可可碱、茶碱、黄嘌呤、鞣质等,并显示出CNS刺激活性、血管舒张活性、利尿活性等(B.S.CHUNG et al.Dohaehyangyakdaesajeon,Youngrim Press,pp.403~405,1998)。
然而,在任何上述引用文献(以引用的方式将它们的公开内容并入本文)中还没有报道或公开关于由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物的毛发生长活性。
因此,本发明的发明者已经寻找到一种比起迄今为止的在先发明(例如,韩国专利公开号10-2014-0114492(A1)中公开的鱼腥草、紫苏叶和茶叶的发酵提取物)而言更有效的治疗脱发的药剂。
通过调查,本发明者发现,本发明的新型创造性的组合比起先前的发明而言显示了预料不到的更有效的治疗脱发的效果,这由各种动物模型实验进行了评估,例如使用C57BL/6小鼠进行生长率测试、HFDPC生长的增殖效果等,并通过确认毛发生长的有效活性最终完成了本发明。
本发明的这些目的和其它目的将从以下提供的本发明的详细公开而变得显而易见。
发明内容
【技术问题】
本发明涉及含有由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物作为活性成分、用于预防或治疗脱发并刺激毛发生长活性的药物组合物及其用途。
本发明还涉及由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物在制造用于在人或哺乳动物中预防和治疗脱发并刺激毛发生长活性的药物中的用途。
本发明还涉及一种用于在遭受脱发的哺乳动物或动物中治疗脱发并刺激毛发生长活性的方法,所述方法包括向有需要的所述哺乳动物或动物给予有效量的由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物;以及药学上可接受的载体。
本发明还涉及含有由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物作为活性成分、用于缓解或预防脱发并刺激毛发生长活性的功能性健康食品及其用途。
本发明还涉及含有由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物作为活性成分、用于预防和改善脱发并刺激毛发生长活性的化妆品组合物及其用途。
【技术方案】
本发明的目的之一是提供一种含有由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物作为活性成分、用于预防和治疗脱发并刺激毛发生长活性的药物组合物。
本文所公开的术语“热加工人参(heat processed ginseng)”包括加工人参(例如红参)的根、叶、果实或根状茎,或是在80-200℃的温度范围、优选100-150℃的温度范围加热0.5-78小时的时间段、优选1-24小时的时间段,以使人参皂苷(Rg3+Rg5+Rk1)与(Rb1+Rb2+Rc+Rd)之比超过1.0的加工人参;或野生人参(例如白参),其中,人参选自于人参、西洋参、三七、竹节参、三叶人参、Panax pseudoginseng、越南人参、Panax elegatior、狭叶竹节参或羽叶三七,优选为人参。
本文所公开的术语“提取物”包括极性溶剂可溶性提取物,例如,在选自于以下溶剂中的至少一种溶剂中可溶的提取物:水、乙醇、丁醇、丙醇、丙酮、乙酸乙酯、己烷、丁二醇、丙二醇、氢化丁二醇、氢化丙二醇、氢化甘油或它们的混合物,优选为水、甲醇、乙醇或它们的混合物,更优选为水和乙醇的混合溶剂,进一步更优选为60%-90%的乙醇。
本文所公开的术语“混合草药的提取物(extract of combined herbs)”包括由混合比为1-10:1-10:1-10:1-10(w/w)、优选为1-5:1-5:1-5:1-5(w/w)、更优选为1-3:1-3:1-3:1-3(w/w)的热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物。
本文所公开的术语“加工提取物(processed extract)”包括以树脂加工的加工提取物,优选为使用反相分配色谱法或使用任何树脂作为固定相(能够将极性物质洗脱而将非极性物质保留在该固定相上)的任何色谱法加工的加工提取物,例如,Sephadex树脂,如Sephadex、SephadexLH20、Sephadex G-25、Sephadex G-10、Sepharose、Superdex、丙烯酸甲酯树脂、羧甲基纤维素、磺丙基纤维素、羧甲基Sephadex、磺丙基Sephadex、羧甲基Sepharose和磺丙基Sepharose等;使用苯乙烯-二乙烯基苯(Stylene-divinylbenzen)共聚物(如Polymer X、HP20、PRP-h1 Polymer等)的反相聚合物树脂或甲基丙烯酸酯(Methacrylate)支持树脂等;并且,所述色谱法使用选自于以下溶剂中的至少一种溶剂作为流动相来洗脱极性物质和保留非极性物质:水、乙腈、低级醇(如甲醇、乙醇、丁醇等)、四氢呋喃(THF)或它们的混合物,优选为水、低级醇(如甲醇、乙醇、丁醇等)或它们的混合物,更优选为水或水与乙醇的混合溶剂,进一步更优选为水或水与甲醇的混合溶剂(从90:10(v/v)起始,直至60:40(v/v))。
本文所公开的术语“脱发症(baldness disorder)”包括雄激素性脱发、老年性脱发、斑秃等。
具体实施方式
在下文中,将对本发明进行详细说明。
可在本发明中使用的草药包括将对本领域技术人员显而易见的、已用于相同或类似目的、并可以取代用于疾病预防和治疗的同一属的植物。
本发明的创造性的混合提取物可通过如下方式制备:
例如,本发明的创造性的提取物可以通过包含如下步骤的方法制备:在步骤1中,将人参在80-200℃的高温、优选100-150℃的高温下加热0.5-78小时的时间段、优选1-24小时的时间段,以使人参皂苷(Rg3+Rg5+Rk1)与(Rb1+Rb2+Rc+Rd)之比超过1.0,得到热加工人参:在步骤2中,将所述热加工人参与鱼腥草、紫苏叶和茶叶以1-10:1-10:1-10:1-10(w/w)、优选1-5:1-5:1-5:1-5(w/w)、更优选1-3:1-3:1-3:1-3(w/w)的混合比混合,得到混合草药;在步骤3中,将所述混合草药与选自于以下溶剂中的至少一种溶剂混合:水、乙醇、丁醇、丙醇、丙酮、乙酸乙酯、己烷、丁二醇、丙二醇、氢化丁二醇、氢化丙二醇、氢化甘油或它们的混合物,优选为水、甲醇、乙醇或它们的混合物,更优选为水和乙醇的混合溶剂,进一步更优选为60%-90%的乙醇,并对与溶剂混合的所述混合草药进行提取,所述提取选自于回流提取、冷水提取、超声提取或其它常规提取,优选以0-150℃的温度、更优选50-120℃的温度及0.1-48小时的时间段、优选0.5-12小时的时间段反复回流提取,优选反复1-10次、更优选反复2-7次,得到混合草药的提取物;在步骤4中,过滤并浓缩所述提取物;在步骤5中,将浓缩提取物悬浮于水中,得到悬浮液;在步骤6中,使用反相分配色谱法或使用任何树脂作为固定相(能够将极性物质洗脱而将非极性物质保留)的任何色谱法对所述悬浮液进行处理,例如,Sephadex树脂,如Sephadex、Sephadex LH20、Sephadex G-25、Sephadex G-10、Sepharose、Superdex、丙烯酸甲酯树脂、羧甲基纤维素、磺丙基纤维素、羧甲基Sephadex、磺丙基Sephadex、羧甲基Sepharose和磺丙基Sepharose等;使用苯乙烯-二乙烯基苯共聚物(如Polymer X、HP20、PRP-h1Polymer等)的反相聚合物树脂或甲基丙烯酸酯支持树脂等;并且,所述色谱法使用选自于以下溶剂中的至少一种溶剂作为流动相来从所述提取物中洗脱极性物质和收集非极性可溶性部分:水、乙腈、低级醇(如甲醇、乙醇、丁醇等)、四氢呋喃(THF)或它们的混合物,优选为水、低级醇(如甲醇、乙醇、丁醇等)或它们的混合物,更优选为水或水与乙醇的混合溶剂,进一步更优选为水或水与甲醇的混合溶剂(从90:10(v/v)起始,直至60:40(v/v));浓缩所述非极性可溶性部分,得到由热加工人参、鱼腥草、紫苏叶和茶叶组成的混合草药的加工提取物。
相应地,本发明还提供了一种制备由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物的方法,所述方法包括如下步骤:在步骤1中,将干燥人参在80-200℃的高温、优选100-150℃的高温下加热0.5-78小时的时间段、优选1-24小时的时间段,以使人参皂苷(Rg3+Rg5+Rk1)与(Rb1+Rb2+Rc+Rd)之比超过1.0,得到热加工人参:在步骤2中,将所述热加工人参与鱼腥草、紫苏叶和茶叶以1-10:1-10:1-10:1-10(w/w)、优选1-5:1-5:1-5:1-5(w/w)、更优选1-3:1-3:1-3:1-3(w/w)的混合比混合,得到混合草药;在步骤3中,将所述混合草药与选自于以下溶剂中的至少一种溶剂混合:水、乙醇、丁醇、丙醇、丙酮、乙酸乙酯、己烷、丁二醇、丙二醇、氢化丁二醇、氢化丙二醇、氢化甘油或它们的混合物,优选为水、甲醇、乙醇或它们的混合物,更优选为水和乙醇的混合溶剂,进一步更优选为60%-90%的乙醇,并对与溶剂混合的所述混合草药进行提取,所述提取选自于回流提取、冷水提取、超声提取或其它常规提取,优选以0-150℃的温度、更优选50-120℃的温度及0.1-48小时的时间段、优选0.5-12小时的时间段反复回流提取,优选反复1-10次、更优选反复2-7次,得到混合草药的提取物;在步骤4中,过滤并浓缩所述提取物;在步骤5中,将浓缩提取物悬浮于水中,得到悬浮液;在步骤6中,使用反相分配色谱法或使用任何树脂作为固定相(能够将极性物质洗脱而将非极性物质保留)的任何色谱法对所述悬浮液进行处理,例如,Sephadex树脂,如Sephadex、Sephadex LH20、Sephadex G-25、Sephadex G-10、Sepharose、Superdex、丙烯酸甲酯树脂、羧甲基纤维素、磺丙基纤维素、羧甲基Sephadex、磺丙基Sephadex、羧甲基Sepharose和磺丙基Sepharose等;使用苯乙烯-二乙烯基苯共聚物(如Polymer X、HP20、PRP-h1Polymer等)的反相聚合物树脂或甲基丙烯酸酯支持树脂等;并且,所述色谱法使用选自于以下溶剂中的至少一种溶剂作为流动相来从所述提取物中洗脱极性物质和收集非极性可溶性部分:水、乙腈、低级醇(如甲醇、乙醇、丁醇等)、四氢呋喃(THF)或它们的混合物,优选为水、低级醇(如甲醇、乙醇、丁醇等)或它们的混合物,更优选为水或水与乙醇的混合溶剂,进一步更优选为水或水与甲醇的混合溶剂(从90:10(v/v)起始,直至60:40(v/v));浓缩所述非极性可溶性部分,得到本发明的由热加工人参、鱼腥草、紫苏叶和茶叶组成的混合草药的加工提取物。
已经证实,该创造性的混合提取物与在先发明(例如,韩国专利公开号10-2014-0114492(A1)中公开的鱼腥草、紫苏叶和茶叶的发酵提取物)相比表现出更有效的毛发生长促进活性和协同效应,这通过各种动物模型实验(如使用C57BL/6小鼠进行的生长率测试;HFDPC生长的增殖效果等)得以证实,并额外发现该混合提取物比在先发明更有优势,例如,凭借该创造性的提取物的最终形式(即,浓缩固体形式相对于在先发明中公开的溶液类型的最终形式),易于控制规定剂量。
本发明的创造性的组合物不具有毒性和副作用,因此可以安全使用。
本发明还提供了由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物在制造用于在哺乳动物或人中治疗和预防脱发症的治疗药剂中的用途。
本发明还提供了含有由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物作为活性成分以及药学上可接受的载体、用于治疗和预防脱发症的药物组合物。
本发明的目的之一是提供一种用于在有需要的哺乳动物或人中治疗或预防脱发症的方法,所述方法包括向所述哺乳动物或人给予有效量的由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物;以及药学上可接受的载体。
基于组合物的总重量,该用于预防脱发症和刺激毛发生长的创造性的组合物可含有0.1-50wt%的上述提取物。
根据本领域公知的使用方法,该创造性的组合物可额外含有常规载体、佐剂或稀释剂。优选地,根据用途和应用方法使用适当的物质作为载体,但并不限于此。适当的稀释剂列于Remington’s PharmaceuticalScience(Mack Publishing co.,Easton PA)的书面文本中。
下文中所述的配制方法和赋形剂仅为示例,本发明并不受其限制。
因此,本发明可以通过如下方式完成:将该创造性的提取物与药学上可接受的载体、佐剂或稀释剂混合成用于预防和治疗目标疾病或病症的药物组合物。
根据本发明的组合物可被提供为包含药学上可接受的载体、佐剂或稀释剂(例如,乳糖、葡萄糖、蔗糖、山梨糖醇、甘露糖醇、木糖醇、赤藓糖醇、麦芽糖醇、淀粉、阿拉伯橡胶(acacia rubber)、藻酸盐(alginate)、明胶、磷酸钙、硅酸钙、纤维素、甲基纤维素、聚乙烯吡咯烷酮、水、羟基苯甲酸甲酯、羟基苯甲酸丙酯、滑石、硬脂酸镁和矿物油)的药物组合物。该制剂还可以额外包含填料、抗凝集剂(anti-agglutinatingagents)、润滑剂、润湿剂、调味剂、乳化剂、防腐剂等。
该创造性的提取物的理想剂量根据受试者的状况和体重、严重程度、药物形式、给药途径和时间会有所不同,并可由本领域技术人员作出选择。然而,为了达到理想的效果,通常推荐以每天0.0001mg/kg体重至100mg/kg体重、优选每天0.001mg/kg体重至100mg/kg体重的量给予本发明的创造性的组合物。该剂量可以每日一次给予或分为若干次给予。
本发明的药物组合物可以通过各种途径给予诸如哺乳动物的受试者动物(大鼠、小鼠、家畜或人)。考虑了所有给药模式,例如,可通过口服给药、经直肠给药,或通过静脉内注射、肌内注射、皮下注射、鞘内注射、硬膜外注射或脑室内注射等进行给药。
本发明提供了一种含有由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物作为活性成分、用于预防或缓解脱发并刺激毛发生长活性的功能性健康食品。
在优选实施方式中,本发明的另一目的是提供一种用于预防或缓解脱发并刺激毛发生长活性的功能性健康食品或保健食品,所述功能性健康食品或保健食品含有由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物;以及营养学上可接受的添加剂。
本文所公开的术语“营养学上可接受的添加剂”包括本领域公知的常规可得的添加剂,如美国食品和药物管理局公开的食品添加剂列表(参见www.fda.gov/food)。
基于组合物的总重量,该用于预防和改善目标疾病的功能性健康食品组合物可含有约0.01-95w/w%、优选0.5-80w/w%的上述粗提取物。
如上所述的粗药物组合物可添加到食品、添加剂或饮料中,用于预防和改善目标疾病。为了预防和改善目标疾病的目的,其中,上述粗药物组合物在食品或饮料中的量对于健康食品组合物而言通常占食品总重量的约0.1-15w/w%、优选为1-10w/w%;或者对于健康饮料组合物而言通常是每100ml健康饮料组合物中1-30g、优选为3-10g。
只要本发明的健康饮料组合物以所指明的比例含有上述提取物作为必需组分,对其它液体组分没有特殊限制,其中,像常规饮料一样,其它组分可以为各种香精(deodorant)或天然碳水化合物。上述天然碳水化合物的实例为单糖(如葡萄糖、果糖等);二糖(如麦芽糖、蔗糖等);诸如糊精、环糊精等的传统糖类;以及糖醇(如木糖醇和赤藓糖醇等)。作为除上述香精外的其它香精,还可有利地使用天然香精(如甜蛋白(taumatin)、甜叶菊提取物如莱包迪苷A(levaudioside A)、甘草甜素等)和合成香精(如糖精、阿斯巴甜等)。每100ml本发明的饮料组合物中上述天然碳水化合物的量通常是约1-20g、优选为5-12g。
除上述组分以外的其它组分为各种营养素、维生素、矿物质和/或电解质、合成调味剂、着色剂和改良剂(improving agent)(奶酪、巧克力等的情况下)、果胶酸及其盐、海藻酸及其盐、有机酸、保护性胶体粘合剂(protective colloidal adhesive)、pH调节剂、稳定剂、防腐剂、甘油、醇、在碳酸饮料中使用的碳化剂等。除上述组分以外的其它组分可为用于制备天然果汁、果汁饮料和蔬菜饮料的果汁,其中,所述组分可以独立使用或联合使用。所述组分的比例并不是很重要,但通常为每100重量份的本发明组合物中占约0-20重量份。
本发明的目的之一是提供一种含有由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物作为活性成分、用于预防或改善脱发并刺激毛发生长活性的化妆品组合物。
其它组分可以是本领域公知的常规化妆品组合物的成分的混合物。
含有上述组合物的化妆品制剂可以制备为任何形式,例如生发水、护发素、护发精华、润发露(hair lotion)、营养润发露、洗发水、冲洗型护发素(hair rinse)、焗油膏(hair treatment)、发乳、营养发乳、发蜡、头发补水霜、头发按摩霜、气雾型喷发胶(hair aerosol)、发膜、营养发膜、洗发皂、头发清洁泡沫、润发油(pomade)、干发剂、头发护理剂、染发剂、烫发剂、头发漂染剂、发胶、发釉(hair glaze)、定型润发油(hairdressing pomade)、定型啫喱(hair lacquer)、头发保湿剂、头发摩丝、眉毛营养剂、睫毛营养剂、头发喷雾、收敛水、营养化妆水(nutrient lotion)、营养霜、按摩霜、精华、面膜、粉底、洁肤水、肥皂、理疗霜(treatment)、美容液等。
本发明的化妆品组合物中可包含选自于由水溶性维生素、脂溶性维生素、肽聚合物、多糖聚合物、鞘脂和海藻提取物组成的组中的额外添加剂。
优选的水溶性维生素为可以与化妆品混合的任何水溶性维生素,然而,优选为诸如维生素B1、维生素B2、维生素B6、吡哆醇、盐酸吡哆醇、维生素B12、泛酸、烟酸、烟酰胺、叶酸、维生素C、维生素H等、它们的盐(如硫胺素盐酸盐、抗坏血酸钠盐等)或它们的衍生物(如抗坏血酸-2-膦酸钠盐、抗坏血酸-2-膦酸镁盐等)的各种维生素,所述水溶性维生素可通过诸如微生物转化法、微生物培养物纯化法、酶法或化学合成法等常规方法来获得。
优选的脂溶性维生素为可以与化妆品混合的任何脂溶性维生素,然而,优选为包括在本发明的实施例中使用的脂溶性维生素在内的诸如维生素A、维生素D2、维生素D3、维生素E(dl-生育酚、d-生育酚、l-生育酚)以及它们的衍生物(如抗坏血酸棕榈酸酯、抗坏血酸硬脂酸酯、抗坏血酸二棕榈酸酯,dl-生育酚乙酸酯、dl-生育酚烟酸酯、维生素E、dl-泛醇、D-泛醇、泛酰基乙醚(pantothenyl ethylether)等)的各种维生素,所述脂溶性维生素可通过诸如微生物转化法、微生物培养物纯化法、酶法或化学合成法等常规方法来获得。
优选的肽聚合物为可以与化妆品混合的任何肽聚合物,然而,优选为胶原蛋白、水解胶原蛋白、明胶、弹性蛋白、水解明胶、角蛋白等,包括在本发明的实施例中使用的肽聚合物。
优选的多糖聚合物为可以与化妆品混合的任何多糖聚合物,然而,优选为羟乙基纤维素、黄原胶(xanthin gum)、透明质酸钠、硫酸软骨素或它们的盐(钠盐等)等。例如,硫酸软骨素或其盐等可通过从哺乳动物或鱼类中常规纯化而得到。
优选的鞘脂为可以与化妆品混合的任何鞘脂,然而,优选为神经酰胺、pit-鞘氨醇、鞘脂多糖等。鞘脂可在常规方法中由哺乳动物、鱼类、贝类、酵母或植物等纯化而得。
优选的海藻提取物为可以与化妆品混合的任何海藻提取物,然而,优选为褐藻提取物、红藻提取物、绿藻提取物等,或者由这些海藻提取物中分离而得的纯化角叉菜胶、藻酸、藻酸钠、藻酸钾。藻类提取物可以通过在常规方法中由海藻纯化而得。
在本发明的化妆品组合物中,除了上述必需成分外,还可根据需要联合使用常规化妆品组合物中所使用的其它成分。
优选的上述其它成分可包括油脂成分、保湿剂、润肤剂(emollients)、表面活性剂、有机染料或无机染料、有机粉末、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、色素、香料、清凉剂(refrigerants)、血液循环促进剂、止汗剂、蒸馏水等。
优选的油脂成分可以包括酯系油、烃系油、硅系油、氟系油、动物油、植物油等。
优选的上述酯系油可包括三-2-乙基己酸甘油酯、2-乙基己酸鲸蜡酯、肉豆蔻酸异丙酯、肉豆蔻酸丁酯、棕榈酸异丙酯、硬脂酸乙酯、棕榈酸辛酯、异硬脂酸异鲸蜡酯、硬脂酸丁酯、亚油酸乙酯、亚油酸异丙酯、油酸乙酯、肉豆蔻酸异鲸蜡酯、肉豆蔻酸异硬脂酸酯、棕榈酸异硬脂酸酯、肉豆蔻酸辛基十二烷酯、异硬脂酸异鲸蜡酯、癸二酸二乙酯、己二酸异丙酯、新戊酸异烷基酯(isoalkyl neopetanoic acid)、三(辛酸,癸酸)甘油酯(glyceryl tri(capryl,capric acid))、三-2-乙基己酸三羟甲基丙酯、三异硬脂酸三羟甲基丙酯、四-2-乙基己酸季戊四醇酯、辛酸鲸蜡酯、月桂酸癸酯、月桂酸己酯、肉豆蔻酸癸酯、肉豆蔻酸肉豆蔻酯、肉豆蔻酸鲸蜡酯、硬脂酸硬脂酯、油酸癸酯、亚油酸鲸蜡酯、月桂酸异硬脂酯、肉豆蔻酸异十三烷酯、棕榈酸异鲸蜡酯、硬脂酸辛酯、硬脂酸异鲸蜡酯、油酸异癸酯、油酸辛基十二烷酯、亚油酸辛基十二烷酯、异硬脂酸异丙酯、2-乙基己酸鲸蜡硬脂酯、2-乙基己酸硬脂酯、异硬脂酸己酯、二辛酸乙二醇酯、二油酸乙二醇酯、二癸酸丙二醇酯、二(辛酸,癸酸)丙二醇酯、二辛酸丙二醇酯、二癸酸新戊二醇酯、二辛酸新戊二醇酯、三辛酸甘油酯、(三)十一烷酸甘油酯、三异棕榈酸甘油酯、三异硬脂酸甘油酯、新戊酸辛基十二烷酯、辛酸异硬脂酯、异壬酸辛酯、新癸酸己基癸酯、新癸酸辛基十二烷酯、异硬脂酸异鲸蜡酯、异硬脂酸异硬脂酯、异硬脂酸辛基癸酯、聚甘油齐墩果酸(oleanoic acid)酯、聚甘油异硬脂酸酯、柠檬酸三异鲸蜡酯、柠檬酸三异烷基酯、柠檬酸三异辛酯、乳酸月桂酯、乳酸肉豆蔻酯、乳酸鲸蜡酯、乳酸辛基癸酯、柠檬酸三乙酯、柠檬酸乙酰三乙酯、柠檬酸乙酰三丁酯、柠檬酸三辛酯、马来酸二异硬脂酯、二2-乙基己基羟基硬脂酸、琥珀酸2-乙基己酯、己二酸二异丁酯、癸二酸(sebasinic acid)二异丙酯、癸二酸二辛酯、硬脂酸胆固醇酯、异硬脂酸胆固醇酯、羟基硬脂酸胆固醇酯、羟基硬脂酸胆固醇酯、油酸胆固醇酯、油酸二氢胆固醇酯、pitsteryl isostearic acid、pitsteryl oleic acid、12-硬脂酰羟基硬脂酸异鲸蜡酯、12-硬脂酰羟基硬脂酸硬脂酯、12-硬脂酰羟基硬脂酸异硬脂酯。
优选的上述烃系油可包括角鲨烯、液体石蜡、α-烯烃低聚物、异链烷烃(isoparaffin)、地蜡(ceresin)、石蜡(paraffin)、液体异链烷烃、聚丁烯、微晶蜡、凡士林等。
优选的硅系油可包括聚甲基硅酮、甲基苯基硅酮、甲基环聚硅氧烷、八甲基聚硅氧烷、十甲基聚硅氧烷、十二甲基环硅氧烷、二甲基硅氧烷-甲基鲸蜡基氧基硅氧烷共聚物、二甲基硅氧烷-甲基硬脂酰基硅氧烷共聚物、烷基改性的硅油、氨基改性的硅油等。
优选的氟系油可包括全氟聚醚等。
优选的动物油或者植物油可以包括鳄梨油、杏仁油、橄榄油、芝麻油、米糠(rice husk)油、红花油、大豆油、玉米油、菜籽油(rape oil)、苦杏仁油(amygdalin oil)、棕榈仁油、棕榈油、蓖麻油(pimaja oil)、葵花籽油、葡萄籽油(fruit seed oil)、棉籽油、椰子油、夏威夷坚果油(cucuinut oil)、小麦胚芽油、大米(rice)胚芽油、酪脂树油(sia butter)、月见草油、marker daymia坚果油、medo home油、蛋黄油、羊毛脂、大麻籽油、貂油、orange ruppy油、荷荷巴油(hohoba oil)、巴西棕榈蜡(carnaubawax)、液体羊毛脂、固体蓖麻油等。
优选的保湿剂可包括水溶性低分子保湿剂、脂溶性低分子保湿剂、水溶性聚合物和脂溶性聚合物。
具体而言,优选的水溶性低分子保湿剂可包括cerin、谷氨酰胺、山梨糖醇、甘露糖醇、吡咯烷酮-羧酸钠、甘油、丙二醇、1,3-丁二醇、乙二醇、聚乙二醇(聚合度>2)、聚丙二醇(聚合度>2)、乳酸、乳酸盐等。
优选的脂溶性低分子保湿剂可包括胆固醇、胆固醇酯等。
优选的水溶性聚合物可包括羧基乙烯基聚合物、聚天冬氨酸盐、黄蓍胶(tragacanth)、黄原胶、HMC(羟甲基纤维素)、HEC(羟乙基纤维素)、HPC(羟丙基纤维素)、羧甲基纤维素、水溶性壳多糖(chitin)、脱乙酰壳多糖(chitosan)、糊精等。
优选的脂溶性聚合物可包括聚乙烯吡咯烷酮-二十碳烯(eicocene)共聚物、聚乙烯基吡咯烷酮-十六碳烯共聚物、硝化纤维素、糊精脂肪酸酯、硅酮聚合物等。
优选的润肤剂可包括长链酰基谷氨酸胆固醇酯、羟基硬脂酸胆固醇酯、12-羟基硬脂酸、rogic acid、羊毛脂脂肪酸胆固醇酯等。
优选的表面活性剂可包括非离子表面活性剂、阴离子表面活性剂、阳离子表面活性剂、两性(ambivalent)表面活性剂等。
具体而言,优选的非离子表面活性剂可包括自乳化型单硬脂酸甘油、丙二醇脂肪酸酯、甘油脂肪酸酯、聚甘油脂肪酸酯、脱水山梨醇脂肪酸酯、聚氧乙烯(POE)脱水山梨醇脂肪酸酯、POE脱水山梨醇脂肪酸酯、POE甘油脂肪酸酯、POE烷基醚、POE脂肪酸酯、POE固体蓖麻油、POE蓖麻油、POE-POP共聚物、POE-POP烷基醚、聚醚改性硅酮、月桂酸烷醇酰胺(alkanol amide)、烷基胺氧化物、氢化大豆磷脂等。
优选的阴离子表面活性剂可包括脂肪酸皂、酰基磺酸盐、烷基磺酸盐、alkyl ally sulfonic acid、烷基萘磺酸盐、烷基磺酸盐、POE烷基醚硫酸盐、烷基酰胺硫酸盐、烷基磷酸盐、POE烷基磷酸盐、烷基酰胺磷酸盐、烷酰基烷基(alkyloylalkyl)牛磺酸盐、N-酰基-氨基酸盐、POE烷基醚羧酸盐、烷基磺基琥珀酸盐、烷基磺基乙酸盐、酰化水解胶原蛋白肽盐(acylated hydrolysable collagen peptide salt)、全氟烷基磷酸酯等。
优选的阳离子表面活性剂可包括烷基三甲基氯化铵、硬脂基三甲基氯化铵、硬脂基三甲基溴化铵、鲸蜡硬脂基三甲基(setostearyltrimethyl)氯化铵、二硬脂基二甲基氯化铵、硬脂基二甲基苄基氯化铵、二十二烷基三甲基(vehenyltrimethyl)溴化铵、苯扎氯铵、二乙基氨基乙基硬脂酰胺、二甲基氨基丙基硬脂酰胺、羊毛脂衍生物季铵盐等。
优选的两性表面活性剂可包括羧基甜菜碱型、酰胺甜菜碱型、羟基磺基甜菜碱型、含磷甜菜碱(phosphobetaine)型、氨基羧酸、咪唑啉衍生物型、酰胺胺型等。
优选的有机染料和无机染料可包括硅酸、无水硅酸、硅酸镁、滑石、ceracyte、云母、高岭土(caolin)、三氧化二铁(bengala)、粘土、膨润土(bentonite)、钛膜云母(titan film mica)、氯氧化铋、氧化锆、氧化镁、氧化锌、氧化钛、氧化铝、硫酸钙、硫酸钡、硫酸镁、碳酸钙、碳酸镁、氧化亚铁(ferrous oxide)、氧化铬、氢氧化铬、炉甘石(calamine)、炭黑以及它们的复合物(complex)作为无机染料;聚酰胺、聚酯、聚丙烯、聚苯乙烯、聚氨酯、乙烯基树脂、尿素树脂、酚树脂、氟树脂、硅树脂、丙烯基树脂、三聚氰胺树脂、环氧树脂、聚碳酸酯树脂、二乙烯基苯-苯乙烯共聚物、丝粉(silk powder)、纤维素、CI颜料黄、CI颜料橙作为有机染料;以及它们的复合物等。
优选的有机粉末可包括金属皂,如硬脂酸钙;烷基膦酸金属盐,如棕榈酸钠锌、月桂酸锌、月桂酸钙;酰基氨基酸多价金属盐,如N-月桂酰基-丙氨酸钙、N-月桂酰基-丙氨酸锌、N-月桂酰基-甘氨酸钙等;酰胺磺酸多价金属盐,如N-月桂酰基-牛磺酸钙、N-棕榈酰基-牛磺酸钙;N-酰基碱性氨基酸,如N-ε-月桂酰基-L-赖氨酸、N-ε-棕榈酰基-赖氨酸、N-棕榈酰基-鸟氨酸、N-月桂酰基-精氨酸、硬化羊毛脂脂肪酸酰基精氨酸等;N-酰基多肽,如N-月桂酰基甘氨酰甘氨酸;氨基脂肪酸,如氨基辛酸、氨基月桂酸等;聚乙烯、聚丙烯、尼龙、聚甲基丙烯酸甲酯、聚苯乙烯、二乙烯基苯-苯乙烯共聚物、四氟乙烯等。
优选的紫外线吸收剂可包括对氨基苯甲酸、对氨基乙基苯甲酸酯、对氨基戊基苯甲酸酯、对氨基辛基苯甲酸酯、乙二醇水杨酸酯、苯基水杨酸酯、辛基水杨酸酯、苄基水杨酸酯、丁基苯基水杨酸酯、homomentyl水杨酸酯、苄基肉桂酸、对甲氧基2-乙氧基乙基肉桂酸、对甲氧基辛基肉桂酸、二对甲氧基单-2-乙基己烷甘油肉桂酸、对甲氧基异丙基肉桂酸、二异丙基-二异丙基肉桂酸酯混合物、urokanic acid、乙基urokanic acid、羟基甲氧基二苯甲酮、羟基甲氧基二苯甲酮磺酸及它们的盐、二羟基甲氧基二苯甲酮、二羟基甲氧基二苯甲酮二磺酸钠、二羟基二苯甲酮、四羟基二苯甲酮、4-叔丁基-4'-甲氧基二苯甲酰甲烷、2,4,6-三苯胺-p-(碳-2'-乙基己基-1'-氧基)-1,3,5-三嗪、2-(2-羟基-5-甲基苯基)苯并三唑等。
优选的防腐剂可包括扁柏酚、三氯酸(trichloric acid)、三氯羟基二苯基醚、氯己啶葡萄酸醛盐、苯氧基乙醇、间苯二酚、异丙基甲基苯酚、甘菊环(azulene)、水杨酸、zinc pilithione、bezalconium HCl、光敏剂301、单硝基愈创木酚钠、十一碳烯酸等。
优选的抗氧化剂可包括丁基羟基茴香醚、没食子酸丙酯、ellisorbate等。
优选的pH调节剂可包括柠檬酸、柠檬酸钠、苹果酸、苹果酸钠、富马酸、富马酸钠、琥珀酸、琥珀酸钠、氢氧化钠、磷酸氢钠等。
优选的醇可包括鲸蜡醇等。
此外,可添加至上述组分中的其它成分及其量在本发明的目的和效果范围内是不受限制的,然而,优选其它成分的量占组合物总量的0.01%-10%、更优选占0.01%-5%。
本发明的化妆品组合物可以被改造为溶液、乳液、粘性混合物等。
上述成分(如水溶性维生素、脂溶性维生素、肽聚合物、多糖聚合物、鞘脂、海藻提取物和在必要时可添加的除上述成分外的可添加成分)可通过在文献中公开的常规方法获得(Matsumoto Mithio;Manual for thedevelopment of transdermal applied preparation.Seisi Press,1st Ed.,1985)。
具体而言,本发明的化妆品制剂可以被制备成本领域公知的任何形式,例如,护肤水、柔肤水、爽肤水、收敛水、化妆水、乳液、保湿化妆水、营养化妆水、按摩化妆水(massage lotion)、营养霜、保湿霜、护手霜、粉底、精华、营养精华、面膜、肥皂、清洁泡沫、洁面乳、洁面霜、身体乳、沐浴液等。
更具体而言,本发明的软膏(paste)、霜或者凝胶制剂可以使用乳糖、滑石、氧化硅(silica)、氢氧化铝、硅酸钙或聚酰胺粉末等作为化妆品载体;并进一步添加氯氟烃、丙烷/丁烷或二甲醚作为推进剂(expellant)。
更具体而言,本发明的溶液或者乳液制剂可以使用溶剂、増溶剂或乳化剂,例如,水、乙醇、异丙醇、碳酸乙酯、乙酸乙酯、苄醇、苄基苯甲酸酯、丙二醇、1,3-丁二醇、甘油脂肪酸酯、PEG或脱水山梨醇脂肪酸酯等。
更具体而言,本发明的悬浊液剂型可使用合适的载体,例如,液体稀释剂,如水、乙醇;或PEG乳化剂,如乙氧基化异硬脂醇、聚氧乙烯山梨醇酯或聚氧乙烯脱水山梨醇酯;以及微晶纤维素、aluminum metahydroxide、膨润土、琼脂或黄蓍胶等。
更具体而言,本发明的含有表面活性剂的清洁制剂可使用脂肪醇硫酸酯、脂肪醇醚硫酸酯、磺基琥珀酸单酯、icetionate、imidazolinum衍生物、甲基牛磺酸盐/酯、sarocynate、脂肪酸酰胺乙基硫酸盐/酯、烷基酰胺甜菜碱、脂肪醇、脂肪酸甘油酯、脂肪酸二乙醇酰胺、植物油、亚油酸(linolic acid)或乙氧基化甘油脂肪酸酯等。
本发明的创造性的组合物不具有毒性和副作用,因此可以安全使用。
【有益效果】
本发明涉及含有由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物、显示出预防脱发症活性和刺激毛发生长活性的组合物。
该创造性的混合提取物与在先发明(例如,韩国专利公开号10-2014-0114492(A1)中公开的鱼腥草、紫苏叶和茶叶的发酵提取物)相比表现出更有效的毛发生长促进活性和协同效应,这通过各种动物模型实验(如使用C57BL/6小鼠进行的生长率测试;HFDPC生长的增殖效果等)得以证实,并额外发现该混合提取物比在先发明更有优势,例如,凭借该创造性的提取物的最终形式(即,浓缩固体形式相对于在先发明中公开的溶液类型的最终形式),易于控制规定剂量。
附图说明
参考附图,由以下详细描述将更清楚地理解本发明的上述目的和其它目的、上述特征和其它特征以及其它优点,其中:
图1显示了本发明的混合提取物的HPLC分析的分析结果;
图2显示了本发明的混合加工提取物的HPLC分析的分析结果。
实施例
对本领域技术人员将显而易见的是,可在不背离本发明的精神或范围的情况下对本发明的组合物、用途和制备作出各种修改和变化。
本发明将更具体地通过以下实施例进行说明。然而,应该了解的是,本发明并不以任何方式受限于这些实施例。
以下参考实施例、实施例和实验实施例旨在进一步说明本发明而不限制本发明的范围。
对比实施例1.在先发明(KR 10-2014-0114492 A1)中公开的提取物的制备
根据KR 10-2014-0114492(A1)中所公开的方法,将100g干燥鱼腥草、60g干燥紫苏叶和40g茶叶粉碎,向其中加入4.0g酵母,混合在一起,并将其密封。密封两天后,向混合物中倒入3.2升30%的乙醇(spirit),温和搅拌,并将含有该溶液的瓶子密封。将瓶子放置在暗室中6个月以对该溶液进行发酵,维持温度为20度左右、相对湿度为55%左右。在发酵期间,每星期一次地摇晃溶液十分钟,使之混合均匀。6个月后打开瓶子,对发酵液进行过滤以去除杂质并收集3.0L发酵提取物。浓缩发酵提取物以获得40g由鱼腥草、紫苏叶以及茶叶组成的混合草药的最终发酵提取物(下文中指定为“RCF”),将其用作以下实验实施例中的对比样品。
实施例1.本发明提取物的制备
1-1.热加工人参(SG)提取物的制备
热加工人参是参照韩国专利登记号192678和美国专利号5776460中所公开的方法制备的,如下所示:
将100g干燥人参(ginseng radix)在120℃加热3小时,并在60℃干燥一夜,以得到33g热加工人参(下文中指定为“SG”)。将10g热加工人参与8倍重量的70%(v/v)乙醇混合,并在超过90℃通过回流提取对溶液提取2小时。所得残留物经滤纸(Whatman公司)过滤,并用旋转蒸发仪(Heidolph,Laboota 4001)浓缩滤液。将浓缩提取物用冷冻干燥机(FDU-210,EYELA)干燥,得到4.0g热加工人参粉状提取物(下文中指定为“SGE”)。
1-2.本发明混合草药提取物(CHE)的制备
将步骤1-1中制备的20g SG热加工人参以及100g鱼腥草、60g紫苏叶和40g茶叶粉碎并混合在一起。向其中加入4升70%(v/v)乙醇,在超过90℃通过回流提取对溶液提取1小时。所得残余物经滤纸(Whatman公司)过滤,并用旋转蒸发仪(Heidolph,Laboota 4001)浓缩滤液。将浓缩提取物用冷冻干燥机(FDU-210,EYELA)干燥,得到84.5g本发明的四种草药的提取物(下文中指定为“CEH”),将其用作以下实验实施例中的测试样品。
实施例2.本发明的混合加工提取物的制备
对5g实施例1中制备的CHE提取物进行离子交换柱色谱,使用DIAION HP-20柱子(Samyang.Co.Ltd.,Korea)作为固定相,洗脱时,通过采用水来使非极性物质被吸附在树脂上,通过采用乙醇来收集被吸附的非极性物质。将收集的洗脱液用旋转蒸发仪(Heidolph,Laboota4001)浓缩,再用冷冻干燥机(FDU-210,EYELA)干燥,得到2.2g本发明的四种草药的经树脂处理的提取物(下文中指定为“CEHR”),将其用作以下实验实施例中的测试样品。
实验实施例1.HPLC组分分析
为分析在实施例中制备的CEH提取物和CEHR提取物中的组分变化,根据下表1中公开的条件进行了以下HPLC(高效液相色谱)分析。
【表1】HPLC分析条件
由图1和图2可以看出,已确认,相比含有无效成分(如多糖)的CEH提取物,HP树脂处理后的CEHR提取物含有更大量的活性成分(已被吸附在HP-20树脂上),即,非极性物质。
实验实施例2.促进毛发生长的效果
为了确认本发明的提取物在预防脱发症活性和刺激毛发生长活性方面的效果,根据文献(Rho SS et al.,J.Dermatol.Sci.,38(2),pp89-97,2005)中公开的方法实施了下面的实验。
2-1.准备
使6周龄小鼠(C57BL/6,18-20g,处于退行期初期,Orient Bio Inc.,Seoul,Korea)适应饲养环境一周,并用麻醉剂进行肌内麻醉(2.5mg/小鼠,氯胺酮,隆朋(rompun),Bayer Korea Inc.)。用刮毛刀除去麻醉小鼠的背部毛发,并将小鼠分成四组,每组各由10只小鼠组成,即,(1)阴性对照组:仅用溶剂处理的处理组;(2)阳性对照组:用米诺地尔(0.5%,w/w)处理的处理组;(3)对比测试组:用对比实施例1中制备的提取物(以剂量依赖性的方式溶解在佐剂中)处理的处理组;(4)测试样品组:用实施例中制备的提取物(以剂量依赖性的方式溶解在佐剂中)处理的处理组。将2.5mg测试样品涂抹在小鼠背部,每天一次,进行20天。
2-2.促进毛发生长的效果
在用数码相机(Canon,Japan)对毛发生长区进行拍摄后,使用图像分析仪(Image-Pro,USA)对毛发再生区/剃毛区面积比进行定量分析,并对测试结果进行5分制评分,即,分数0:无效;分数1:略微有效;分数2:一般有效;分数3:很有效;分数4:极其有效(如表2所示)。
【表2】用于确定的评分标准
毛发生长率 | 分数 | 标准(Abbr.) |
0~20% | 0 | 无效(IE) |
20~40% | 1 | 略微有效(ME) |
40~60% | 2 | 一般有效(FE) |
60~70% | 3 | 很有效(PE) |
>70% | 4 | 极其有效(MPE) |
作为结果,如从下表3中可以看出的,已经证实,从实验开始后15天,相比用在KR 10-2014-0114492(A1)中公开的RCF提取物处理的对比测试组以及仅用溶剂处理的阴性对照组和用米诺地尔(0.5%,w/w)处理的阳性对照组,本发明的提取物(即,CEH和CEHR提取物)具有更好的治疗脱发的效果。
【表3】毛发生长活性
实验实施例3.HFDPC的增殖效果
为确认本发明的提取物对HFDPC(毛囊毛乳头细胞)的增殖效果的影响,根据文献(韩国专利登记号10-1443142 B1)中公开的已知方法实施以下实验。
3-1.步骤1:HFDPC细胞培养
将HFDPC(毛囊毛乳头细胞)(ATCC)以2×105个细胞/板的密度接种至T75培养板(FA3024,Falcon)上,并在含有IX抗生素-抗霉菌的S(+)补充混合培养基(LS203-01,Welgene Inc.)中培养4-5天。
培养后,将细胞以6000个细胞/孔的密度转移至48孔板(30048,SPL Life Sciences),并在S(-)无补充培养基(Welgene Inc.)中培养1天。
3-2.步骤2:样品处理
在细胞贴壁后,移除S(+)生长培养基,用S(-)无补充培养基稀释不同浓度的测试样品(CEH和CEHR),并分成五组,即,(1)仅由S(-)培养基处理的阴性对照组;(2)由40μg/mL测试样品处理的测试样品组;(3)由80μg/mL测试样品处理的测试样品组;(4)由160μg/mL测试样品处理的测试样品组;以及(5)仅由S(+)补充混合培养基处理的阳性对照组。
在处理后24小时、48小时、72小时的间隔处将各孔中的培养基更换为新鲜培养基,测定各组的细胞增殖。
以与上述类似的程序测定RCF提取物处理的对比测试组的细胞增殖。
3-3.步骤3:HFDPC增殖的测定
HFDPC细胞增殖利用EZ-Cytox试剂盒(EZ-3000,DAEILLABService co.,Ltd.,Korea)来测定,这是一种使用WST(高灵敏水溶性四唑盐)的细胞存活力应答试剂盒,其已经被广泛用于通过与细胞内所有脱氢酶反应来特异性测定细胞状况(EZ-Cytox Manual,DAEILLABService co.,Ltd.,Korea)。
将每孔中的培养基以48孔板的每孔含有200μl的体积替换成新鲜S(-)培养基。每孔用20μl EZ-Cytox试剂盒(EZ-3000,DAEILLAB Service Co.,Ltd.,Korea)中提供的反应液处理各细胞,并使细胞在37℃于5%CO2培养箱(311,Forma Co.)中培养2小时。用酶标仪(SpectraMax 340 PC,Molecular Device)在450nm波长下测量各组的吸光度,以O.D.比值为基础计算和分析细胞数量。
每组中对HFDPC细胞增殖活性影响的结果如表4所示。
【表4】HFDPC细胞增殖活性
结果证实,与阴性对照组相比,用40μg/mL、80μg/mL和160μg/mL的CEH提取物或CHER提取物处理的测试组显示出更高的HFDPC细胞增殖,增加了19.2%、28.6%和32.9%(CEH提取物)或增加了32.1%、48.9%和60.4%(CHER提取物);与用RCF提取物处理的对比组相比较,用本发明提取物处理的测试组表现出预料不到的更有效的对HFDPC细胞增殖的影响,这表明本发明的提取物更有效地活化了HFDPC细胞增殖并具有有效的脱发治疗作用,这可在表4中得以看出。
因此,已证实本发明的提取物对促进毛发增长有效,并具有多重优点,例如,与伴有多种缺点的传统可得的化学药物相比较更安全并几乎无副作用。
在下文中,将描述本发明的创造性的提取物的配制方法及其中所含的各种赋形剂,但本发明并不仅限于此。代表性的制备例描述如下。
散剂的制备
提取物(CEH) 500mg
乳糖 100mg
滑石 10mg
散剂的制备是将上述组分混合并填充密封包装。
片剂的制备
片剂的制备是将上述组分混合并压片。
胶囊的制备
胶囊的制备是通过常规明胶制备方法将上述组分混合并填充明胶胶囊。
注射剂的制备
注射剂的制备是通过常规注射剂制备方法将活性组分溶解,然后将所有组分填充到2ml样品中并灭菌。
液体药剂的制备
液体药剂的制备是通过常规液体药剂制备方法在棕瓶中将组分溶于蒸馏水中(含适当剂量的柠檬香),混合,用蒸馏水调整至100ml并灭菌。
功能性健康食品的制备
上述维生素和矿物质混合物可以以多种方式发生改变。这样的变化不应该被视为是偏离本发明的精神和范围。
健康饮料的制备
健康饮料的制备是通过常规健康饮料制备方法将活性组分溶解,混合,在85℃搅拌1小时,过滤后将所有组分填充在2升容器中并灭菌。
软膏(ointment)的制备
软膏的制备是通过常规软膏制备方法混合上述组分,填充在软膏管中。
生发水的制备
生发水的制备是根据常规生发水制备方法溶解活性组分。
皮肤调理液(skin conditioner)的制备
皮肤调理液的制备是根据常规皮肤调理液制备方法溶解活性组分。
润发露的制备
润发露的制备是根据常规润发露制备方法溶解活性组分。
洗发皂的制备
洗发皂的制备是根据常规洗发皂制备方法溶解活性组分。
霜剂的制备
霜剂的制备是根据常规霜剂制备方法溶解活性组分。
美容液的制备
美容液的制备是根据常规美容液制备方法溶解活性组分。
如此描述的本发明显然可以变化成多种方式。这些变化并不被视为背离本发明的精神和范围,并且,对于本领域技术人员而言将显而易见的所有这些修改旨在涵盖于所附权利要求的范围内。
【工业实用性】
如本发明所描述的,本发明涉及一种用于预防和治疗脱发并刺激毛发生长活性的组合物,该组合物含有由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物作为活性成分。
该创造性的混合提取物与在先发明(例如,韩国专利公开号10-2014-0114492(A1)中公开的鱼腥草、紫苏叶和茶叶的发酵提取物)相比表现出更有效的毛发生长促进活性和协同效应,这通过各种动物模型实验(如使用C57BL/6小鼠进行的生长率测试;HFDPC生长的增殖效果等)得以证实,并额外发现该混合提取物比在先发明更有优势,例如,凭借该创造性的提取物的最终形式(即,浓缩固体形式相对于在先发明中公开的溶液类型的最终形式),易于控制规定剂量。
Claims (11)
1.一种用于预防和治疗脱发并刺激毛发生长活性的药物组合物,所述药物组合物含有由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物作为活性成分。
2.根据权利要求1所述的药物组合物,所述热加工人参是红参的根、叶、果实或根状茎,或是通过在80-200℃的温度范围加热0.5-78小时的时间段,以使人参皂苷(Rg3+Rg5+Rk1)与(Rb1+Rb2+Rc+Rd)之比超过1.0而制造的加工人参;其中,人参选自于人参(Panax ginseng)、西洋参(Panax quinquefolius)、三七(Panax notoginseng)、竹节参(Panaxjaponica)、三叶人参(Panax trifolia)、Panax pseudoginseng、越南人参(Panax vietnamensis)、Panax elegatior、狭叶竹节参(Panax wangianus)或羽叶三七(Panax bipinratifidus)。
3.根据权利要求1所述的药物组合物,所述提取物是在选自于以下溶剂中的至少一种溶剂中可溶的提取物:
水、乙醇、丁醇、丙醇、丙酮、乙酸乙酯、己烷、丁二醇、丙二醇、氢化丁二醇、氢化丙二醇、氢化甘油,或它们的混合物。
4.根据权利要求1所述的药物组合物,所述混合草药的提取物是由混合比为1-10:1-10:1-10:1-10(w/w)的热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物。
5.根据权利要求1所述的药物组合物,所述加工提取物是使用反相分配色谱法或使用能够将极性物质洗脱而将非极性物质保留的任何树脂作为固定相的任何色谱法加工的加工提取物,其中,所述色谱法使用选自于以下树脂中的至少一种树脂作为固定相:Sephadex、Sephadex LH20、Sephadex G-25、Sephadex G-10、Sepharose、Superdex、丙烯酸甲酯树脂、羧甲基纤维素、磺丙基纤维素、羧甲基Sephadex、磺丙基Sephadex、羧甲基Sepharose和磺丙基Sepharose;使用选自于Polymer X、HP20和PRP-h1 Polymer的苯乙烯-二乙烯基苯共聚物的反相聚合物树脂或甲基丙烯酸酯支持树脂;并且,所述色谱法使用选自于以下溶剂中的至少一种溶剂作为流动相来洗脱极性物质和保留非极性物质:水、乙腈、甲醇、乙醇、丁醇、四氢呋喃(THF)或它们的混合物。
6.根据权利要求1所述的药物组合物,所述脱发选自于雄激素性脱发、老年性脱发或斑秃。
7.一种用于制备根据权利要求1所述的提取物或其加工提取物的方法,所述方法包括以下步骤;
在步骤1中,将干燥人参在80-200℃的高温下加热0.5-78小时的时间段,以使人参皂苷(Rg3+Rg5+Rk1)与(Rb1+Rb2+Rc+Rd)之比超过1.0,得到热加工人参:
在步骤2中,将所述热加工人参与鱼腥草、紫苏叶和茶叶以1-10:1-10:1-10:1-10(w/w)的混合比混合,得到混合草药;
在步骤3中,将所述混合草药与选自于以下溶剂中的至少一种溶剂混合:水、乙醇、丁醇、丙醇、丙酮、乙酸乙酯、己烷、丁二醇、丙二醇、氢化丁二醇、氢化丙二醇、氢化甘油或它们的混合物,并对与溶剂混合的所述混合草药进行提取,所述提取选自于回流提取、冷水提取、超声提取或其它常规提取,以0-150℃的温度及0.1-48小时的时间段提取1-10次,得到混合草药的提取物;
在步骤4中,过滤并浓缩所述提取物;
在步骤5中,将浓缩提取物悬浮于水中,得到悬浮液;
在步骤6中,使用选自于以下树脂中的至少一种树脂作为固定相来对所述悬浮液进行反相分配色谱法:Sephadex、Sephadex LH20、SephadexG-25、Sephadex G-10、Sepharose、Superdex、丙烯酸甲酯树脂、羧甲基纤维素、磺丙基纤维素、羧甲基Sephadex、磺丙基Sephadex、羧甲基Sepharose和磺丙基Sepharose;并且,所述反相分配色谱法使用选自于以下溶剂中的至少一种溶剂作为流动相来从所述提取物中洗脱极性物质和收集非极性可溶性部分:水、乙腈、甲醇、乙醇、丁醇、四氢呋喃(THF)或它们的混合物;以及
浓缩所述非极性可溶性部分,得到根据权利要求1所述的混合草药的加工提取物。
8.一种用于预防或缓解脱发并刺激毛发生长活性的功能性健康食品,所述功能性健康食品含有由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物作为活性成分。
9.一种用于预防或改善脱发并刺激毛发生长活性的化妆品组合物,所述化妆品组合物含有由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物作为活性成分。
10.根据权利要求9所述的化妆品组合物,其中,所述组合物为如下形式的组合物:
生发水、护发素、护发精华、润发露、营养润发露、洗发水、冲洗型护发素、焗油膏、发乳、营养发乳、发蜡、头发补水霜、头发按摩霜、气雾型喷发胶、发膜、营养发膜、洗发皂、头发清洁泡沫、润发油、干发剂、头发护理剂、染发剂、烫发剂、头发漂染剂、发胶、发釉、定型润发油、定型啫喱、头发保湿剂、头发摩丝、眉毛营养剂、睫毛营养剂、头发喷雾、收敛水、营养化妆水、营养霜、按摩霜、精华、面膜、粉底、洁肤水、肥皂、理疗霜和美容液。
11.由热加工人参、鱼腥草、紫苏叶以及茶叶组成的混合草药的提取物或其加工提取物在制造用于在哺乳动物或人中治疗和预防脱发症的治疗药剂中的用途。
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