TW201517929A - 使用黑莓萃取物用於增進髮質之方法及組成物 - Google Patents
使用黑莓萃取物用於增進髮質之方法及組成物 Download PDFInfo
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- TW201517929A TW201517929A TW103104196A TW103104196A TW201517929A TW 201517929 A TW201517929 A TW 201517929A TW 103104196 A TW103104196 A TW 103104196A TW 103104196 A TW103104196 A TW 103104196A TW 201517929 A TW201517929 A TW 201517929A
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- blackberry
- hair
- hair growth
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Abstract
以有效量的黑莓萃取物局部塗敷於皮膚上希望毛髮生長的區域來誘發毛髮生長及改善髮質的組成物及方法。
Description
本發明係關於利用來自黑莓植物(黑莓(Rubus fruticosus))的萃取物,來誘發毛髮生長以及改善髮質的局部組成物及方法。
男性與女性的遺傳特質和自然老化過程及/或疾病,促成脫髮且毛髮生長較緩慢。大約有50%的人口到了50歲時,某種程度上會顯示這樣的特徵,並且會在12歲與40歲之間開始出現毛髮稀疏的現象,這與性別無關。因此,能夠刺激毛髮生長並且防止與減緩或減少脫髮的藥劑,不僅能有助於治療禿髮,還能正面地影響與毛髮疾病有關的心理與社會事件。研究顯示,伴隨脫髮而來的心理社會衝擊,包括與負面刻板印象有關的身體意象不滿意,如感覺更老、更衰弱及缺乏魅力。
包括敏諾西迪(Minoxidil)(落健(Rogaine))、非那雄胺(Finasteride)(柔沛(Propecia))及度他雄胺(Dutasteride)(適尿通(Avodart))的藥物係經核可用於脫髮治療。然而,
這些藥物需要醫療處方,並且僅對一定百分比的人口有作用。再者,由於激素效應,這些藥物中有一些不允許女性使用。例如,絕經前期的婦女不應該服用非那雄胺(Finesteride),原因在於男性擬雌雄同體對胎兒有危險。已發現非那雄胺(Finesteride)會人為地降低前列腺特有抗原(PSA)試驗、標準篩選試驗對前列腺癌的成效,這會延誤疾病的檢測及治療。
敏諾西迪(Minoxidil)是一種局部塗敷用藥,其對於一部分患者在誘發毛髮生長方面有效,並且僅在頭皮上面重新生長毛髮。此外,其對老年人功效有限。敏諾西迪(Minoxidil)在十名男性患者中,可減緩其中五名的脫髮率。
其它可用於治療脫髮的治療包括激烈的外科技術,如頭皮縫縮、頭皮拍打或毛囊單元移植。這些外科手術帶來併發症的風險,如與供體區有關的髮際線升高、毛髮生長方向外貌不自然及壞死的可能性、失去知覺及術後照護,遑論高成本。
聲稱誘發毛髮生長的草本製劑(例如:草本洗髮露(Hair Prime))成本低,但效用很有限。
M.赫耳曼(Herrmann)等人已說明一種氫醇黑莓葉萃取物(SymMatrix),其表現出MMP-1、MMP-2、及MMP-9的抑制活性。(請參閱,例如第US2008/0095719號文獻)
令人驚訝的是,我們已發現一種濃縮型、含水的黑莓萃取物,其可藉由對一患者的頭皮、皮膚、睫毛、眉毛、髭部位或鬍鬚部位,塗敷一組成物而有效誘發毛髮生長,所述
組成物包含此萃取物、主要是由此萃取物所組成,一局部活性組成物包含一濃度至少90mg萃取物/ml溶液、但小於300mg/ml的一黑莓萃取物,其在每日施用至少五(5)到七(7)天後,可開始對關注區增加毛髮覆蓋。在以一濃縮型黑莓萃取物治療的所有動物中,我們觀察到體內毛髮生長有效提升。更加令人驚訝的是,本發明的組成物含有黑莓萃取物,其最初是在快速進入毛髮生長初期階段(亦即,毛囊的活性生長階段)前,誘發一可見的靜止期階段(亦即,棍狀毛脫落)。本發明的組成物在超過至少八天這段期間治療的動物中,100%誘發毛髮生長初期。
如在本文中所使用的,「黑莓萃取物」表示一懸鉤子屬植物的萃取物。較佳的是,本發明之組成物中,利用的物種為黑莓(Rubus fruticosus)。黑莓萃取物可為一種由多種化合物構成的摻合物,所述化合物係分離自懸鉤子屬植物。在一實施例中,此多種化合物係分離自植物的花卉。在另一實施例中,此多種化合物可分離自植物的乾燥花。它們也可分離自植物的一或多個部分,包括植物的整株植物、花卉、籽、根、根莖、莖幹、果實及/或葉子。較佳的是,可用於本發明多種組成物的黑莓萃取物,係分離自黑莓植物的葉子。
萃取過程可包括物理地採下一株黑莓植物並且予以磨碎。所屬技術領域中具有通常知識者已知的有機溶劑萃取過程,也可用於取得可用於本發明多種組成物中的黑莓萃取物。如較低C1-C8醇、C1-C8烷基多元醇、C1-C8烷基酮類、C1-C8烷基醚類、醋酸C1-C8烷基酯、及氯仿之類的溶劑、及/或水之類的無機溶劑、鹽酸之類的無機酸、以及氫氧化鈉之類的無機鹼,都可用於自黑莓植物萃取活性化合物。
一黑莓葉萃取物也可使用如乙醇或其組合的醇作為萃取劑,藉由一以水製作的萃取予以製備。然而,一萃取物係以一包括乙醇與水萃取劑兩者的萃取劑予以製作。
黑莓葉較佳的是在萃取前令其乾燥。也較佳的是僅使用黑莓植物的葉子以供萃取,而不使用其它植物部分,如黑莓的果實(漿果)、其分枝、花卉或根。
在一實施例中,生產一黑莓葉萃取物的萃取過程可具有下列步驟:a)對黑莓葉添加一含有一醇的萃取劑,所述醇係選自由甲醇、乙醇、n-丙醇、異丙醇所組成之群組、以及b)以萃取劑萃取黑莓葉達72小時。
萃取劑對葉子固體質量的比率,其建立方式較佳的是,取得相對於葉子固體至少10倍質量的萃取劑、以及較佳的是相對於葉子固體,不超過50倍質量的萃取劑,較佳的是10至20倍質量。對於萃取,尤其較佳的是使用相對於葉子固體14至18倍質量的萃取劑。良好成效係以一16倍質量的含乙醇溶劑達成(係再一次相對於葉子固體而言)。
進行步驟(b)所用的萃取時間最多72小時,但也可更短。若萃取時間特別短,則在步驟(b)得到的是一較為稀釋的
萃取物。因此,步驟(b)中,萃取黑莓葉的時間較佳是至少一(1)小時,而更佳則是至少兩(2)小時。較佳萃取時間的選擇,係基於待萃取黑莓葉的品質,尤其是其葉齡,及其它萃取條件,尤其是萃取溫度。
在萃取溫度升高的情況下,例如,範圍自約60至約100℃的萃取溫度,較佳的是在自約80至約100℃的範圍內,萃取時間較佳的是約一小時至約六小時,而更較佳的是約二至約四小時。
另外,最佳的是在步驟(b)中,藉由回流萃取劑進行萃取,尤其是在範圍自約60℃至約100℃的萃取溫度下進行,而更較佳的是在自約80至約100℃的範圍內進行。當使用回流程序時,萃取時間較佳的是不超過約24小時。
萃取溫度係基於使用的萃取劑而建立的。若使用的是一含乙醇溶劑,一萃取溫度較佳是在自約60℃至約100℃的範圍內,尤其一範圍自約80℃至約100℃的萃取溫度,在以一由乙醇與水構成之混合物當作萃取劑的情況下尤其如此。
較佳的是,萃取劑含有一低碳烷基醇溶劑,更較佳的是乙醇,一相對於總萃取劑的比例為重量至少約20%。較佳的是,萃取劑也應含有水,水相對於總萃取劑的一比例為重量至少15%。萃取劑較佳是同時兼含一相對於總萃取劑重量至少20%的酒精(較佳的是乙醇)、以及相對於總萃取劑比例為重量至少15%的水。
在本發明的組成物及方法中尤其有效的黑莓葉萃取物,其取得係用一含有乙醇與水的萃取物,比率為約2:8(2
成重量的乙醇混以8成重量的水)至約8:2,更較佳的是比率為約3:7至約7:3,而最佳的是比率為約3:7至約1:1。
因此,在一較佳實施例中,黑莓萃取物為一黑莓葉萃取物,亦即,萃取物係產自黑莓植物的的葉子。在一特別較佳實施例中,黑莓萃取物係產自黑莓的葉子。在另一特別較佳實施例中,黑莓萃取物係以一由水與一較低醇(如上述乙醇)構成的混合物,藉由萃取黑莓的葉子予以生產。
一特別適用的黑莓萃取物,其產製係藉由萃取黑莓的葉子,並經市售已複合成活性約5%至約10%的水與乙醇混合物,及附美國紐澤西泰特波羅公司(Symrise Inc.of Teterboro,NJ)出產品名為「SymMatrix」之麥芽糊精基質。
美國第2008/0095719號專利公開案中,說明用於製備一適當黑莓葉萃取物的詳細步驟,其內容係完整合併在本文中。
如本文中所使用,「局部塗敷」表示藉由手或一塗敷器,以一諸如拭布、噴塗器、滾珠、噴霧劑之類的方式,在外層皮膚上直接敷布或撒敷。
如本文中所使用,「裝飾可接受」表示此與所形容之產物或化合物,適合用於接觸組織(如皮膚)而無異常毒性、不相容性、不安定性、刺激性、過敏反應及類似物。這個術語的用意不在於限制其形容僅當作一化妝品的成分/產物(例如:成分/產物可當作一藥品)。
如本文中所使用,「局部載體」表示一或多種相容固體或液體填料稀釋劑,其適用於對一哺乳動物進行局部投藥。
局部載體的實例包括但不限於水、蠟、油、軟化劑、乳化劑、增稠劑、膠化劑、及其混合物。
如本文中所使用,「毛髮」表示頭皮、頭部、臉部及/或身體的毛髮,包括但不限於頭皮、眼睫毛、眉毛、髭、鬍鬚、耳、鼻腔、胸部、陰部處、助劑及類似物。
如本文中所使用,「誘發毛髮生長」表示早期誘發新毛髮週期的生長、及/或延長毛髮週期活性生長階段(毛髮生長初期)、及/或提升毛髮的生長率、及/或加大毛幹的寬度,包括但不限於毛髮生長的誘發以及使其更可用眼睛看到。
如本文中所使用,「改善髮質」表示加大毛幹的直徑、及/或增進像髮卷、毛髮光澤與毛髮厚度之類毛髮的可見屬性、及/或影響毛幹及/或毛小皮的特性,包括但不限於創造更平滑的面容或感覺、及/或提升光澤。
如本文中所使用,「安全及有效用量」表示一生理活性化合物或組成物的用量,所述用量足以在待調整或治療狀況下誘發一正修飾、(例如毛髮生長)但低到足以避免嚴重副作用。化合物或組成物的安全及有效用量,將隨多種因素而變,包含所治療的特殊狀況、終端用戶的年齡與物理狀況、所治療/預防狀況的嚴重程度、治療期間、其它治療的本質、所用的特定化合物或產物/組成物、所利用的特殊裝飾可接受載體、以及諸如此類的因素。
可用於本發明之局部組成物,含有適於局部塗敷於毛髮和頭皮之配方。在一實施例中,組成物含有一黑莓萃取物以及一裝飾可接受局部載體。在一實施例中,該裝飾可接受的局部載體,組成自約75至約95重量百分比的組成物,或更較佳是自約75至約85重量百分比的組成物。
可將本發明的組成物製成琳琅滿目的產物類型,其包括但不限於固體及液體組成物,如洗劑、乳劑、凝膠、粉條、噴霧劑、軟膏、洗潔液與洗潔皂、洗髮精、糊劑、粉末、泡沫、慕絲、以及拭布。這些產物類型可含有許多種裝飾可接受的局部載體,包括但不限於溶液、乳液(例如:微乳液及奈米乳液)、凝膠、固體以及脂質體。此類載體的非限制實例係在本文中提出。熟習此項技藝之人士可配製出其他載體。
可用於本發明的局部組成物可予以配製成溶液。溶液較佳的是應該包括一含水溶劑(例如:一自約75%至約95%、或自約75%至約85%的裝飾可接受含水溶劑)。更較佳的是,此類組成物應該含有約30%的溶劑,但這可隨配方而變。此類溶劑可包括乙醇、丙二醇、聚乙二醇、其混合物及類似物,其對於成功遞送至毛囊是良好的載體。
可用於本發明的局部組成物可予以配製成一含有一軟化劑的溶液。此類組成物較佳的是含有自約2%至約50%的軟化劑。如本文中所使用,「軟化劑」是指用於預防或緩和乾燥、以及用於護膚的材料。琳琅滿目的適合軟化劑係已知並且可用在本文中。The International Cosmetic Ingredient
Dictionary and Handbook,第14版,2012,第3卷,Gottschlack與Breslawec編著,第3868至3880頁,由Personal Care Products Council出版(下文簡稱為「INCI字典」),在此以引用之方式併入本案以為參照。
一洗劑可由一溶液所製成。洗劑一般含有自約1%至約20%(更較佳的是自約5%至約10%)的軟化劑、以及自約50%至約90%(更較佳的是自約60%至約80%)的水。
另一種產物可以是一其為乳劑的溶液。一乳劑一般包含自約5%至約50%(更較佳的是自約10%至約20%)的軟化劑、以及自約45%至約85%(更較佳的是自約50%至約75%)的水。
可由溶液配製的又另一類的產品是軟膏。一軟膏可由一單純鹼性的動物或植物油、或半固體烴類所組成。軟膏可含有自約2%至約100%之軟化劑、以及自約0.1%至約2%的增稠劑。INCI手冊的第1693至1697頁含有一系列可接受的增稠劑或增黏劑,其可用於本發明的組成物及方法。
可用於本發明的局部組成物較佳的是也可配製成乳液。若載體為一乳膠,自約1%至約10%(較佳的是自約2%至約5%)的載體應該由一或多種乳化劑構成。乳化劑可以是非離子的、陰離子的、或陽離子的。可在例如INCI手冊的第3816-191及3954-67頁找到適合的乳化劑。
也可將洗劑及乳劑配製成乳液。一般而言,此類洗劑較佳的是含有自0.5%至約5%的乳化劑。此類乳劑一般將包含自約1%至約20%(較佳的是自約5%至約10%)的軟化劑;
自約20%至約80%(較佳的是自30%至約70%)的水;以及自約1%至約10%(較佳的是自約2%至約5%)的乳化劑。
水中油類型及油中水類型的單一乳液皮膚保養製劑(例如洗劑及乳劑),為化妝品領域所熟知,且可用於本發明。如水中油中水類型的多相乳液組成物也可用於本發明。一般來說,此種單一或多相的乳液含有水、軟化劑及乳化劑作為基本的成分。
本發明的組成物也可以洗髮精、毛髮調理產物、免洗髮膜、慕絲、噴霧劑的形式,結合染料及其它毛髮保養產物,搭配本發明新穎組成物的局部塗敷,同時用於清潔、治療、調理並且著色毛髮。
可將本發明的局部組成物配製成一凝膠(例如:一使用適合膠化劑的含水凝膠)。適用於水性凝膠之膠凝劑包括但不限於:天然樹膠、丙烯酸及丙烯酸酯聚合物與共聚物,以及纖維素衍生物(如羥甲基纖維素及羥丙基纖維素)。適當的油(例如礦油)用膠化劑,包括但不限於氫化丁烯/乙烯/苯乙烯共聚合物、以及氫化乙烯/丙烯/苯乙烯共聚合物。典型上此種凝膠包含介於約0.1%與5%重量比之間的此種膠化劑。可將微凝膠用於增進配方的毛囊遞送。
也可將本發明的局部組成物配製成一固體配方(例如:一蠟質粉條、睫毛膏、皂條組成物、粉末、或一含粉末之拭布。
可用於本發明的局部組成物,除了前述組分外,還可含有琳琅滿目的額外油可溶性、有機溶劑可溶性、及/或水可溶性材料,其在習知上,係以其所屬領域公認的等級,用
於皮膚與毛髮上用的組成物。例如,一由70%乙醇與30%丙二醇、或這兩種藥劑可變用量組成的配方,可用於增進活性劑遞送。
在一實施例中,本發明的組成物含有一或多種界面活性劑。在一實施例中,組成物含有一起泡性界面活性劑。所謂的一「起泡性界面活性劑」,指的是一在與水結合,並且機械性攪拌時,起泡沫的界面活性劑。在一實施例中,於ASTM Annual Book of ASTM Standards 1001第15.04卷第15段所提出的界面活性劑起泡性質標準測試方法(Standard Test Method for Foaming Properties of Surface-Active Agents)D1173-53中(使用的是一每公升5公克的濃度、49℃的溫度、以及每加侖8個顆粒的水硬度),起泡性界面活性劑具有一例如至少50mm之類,至少20mm的初始泡沫高度讀數。起泡性界面活性劑的實例包括但不限於陰離子的、非離子的、陽離子的、以及兩性的起泡性界面活性劑。
陰離子的起泡性界面活性劑的非限制實例,包括選自由肌氨酸、硫酸鹽、羥乙基磺酸鹽、酒石酸鹽、磷酸鹽、乳醯乳酸(lactylates)、以及麩胺酸所組成之群組。特定實例包括但不限於選自由硫酸月桂酯鈉、硫酸月桂酯銨、月桂醇聚醚硫酸銨(ammonium laureth sulfate)、月桂醇聚醚硫酸鈉、十三烷醇聚醚硫酸鈉(sodium trideceth sulfate)、十六酯硫酸銨(ammonium cetyl sulfate)、十六酯硫酸鹽鈉、椰油醯基羥乙基磺酸銨、十二醯基羥乙基磺酸鈉、十二醯基乳醯乳酸鈉、
十二醯基乳醯乳酸三乙醇胺、己醯乳醯乳酸鈉、十二醯基肌氨酸鈉、十四醯肌氨酸鈉、椰油醯基肌氨酸鈉、十二醯基甲基酒石酸鈉、椰油醯基甲基酒石酸鈉、十二醯基麩胺酸鈉、十四醯麩胺酸鈉、以及椰油醯基麩胺酸鈉及其混合物所組成之群組。
非離子的起泡性界面活性劑的非限制實例,包括選自由烷基配醣體、烷基聚葡萄糖苷、多羥基脂肪酸醯胺、烷氧基化脂肪酸酯、起泡性蔗糖酯、胺氧化物、及其混合物所組成之群組。對於選自由C8-C14葡萄糖醯胺、C8-C14烷基聚葡萄糖苷、蔗糖椰油、蔗糖十二酸酯、月桂胺氧化物、椰油胺氧化物、及其混合物所組成之群組,特定實例包括但不限於非離子的界面活性劑。
兩性的起泡性界面活性劑的非限制實例(其亦包括兩性離子起泡性界面活性劑),係選自由甜菜鹼、二甲基磺基甜菜鹼、丙基羥基磺基甜菜鹼、亞胺基甲酸烷基酯、氨基二鏈烷酸鹽、氨基酸鏈烷酸酯、及其混合物所組成之群組。
本發明兩性的界面活性劑的非限制實例,包括月桂醯兩性基二乙酸二鈉、月桂醯兩性基乙酸鈉、二甲基甜菜鹼十六酯、椰油醯胺丙基甜菜鹼、椰油醯胺丙基羥基二甲基磺基甜菜鹼、以及其混合物。
在一實施例中,根據本發明之組成物,可進一步含有一或多種額外的裝飾活性劑、以及前述之組分。所謂的一「裝飾活性劑」是指一化合物,其可為一合成化合物,或一分離、
純化、或濃縮自一天然來源的化合物、或一含有一化合物混合物的天然萃取物,其對組織具有一裝飾或治療功效,包括但不限於:如抗醛母劑、抗真菌、及抗細菌劑之類的抗微生物劑、抗發炎劑、抗老化劑、抗寄生生物劑、外用鎮痛劑、防晒劑、光保護劑、抗氧化劑、角質層分離劑、清潔劑/界面活性劑、潤膚霜、營養素、維生素、礦物質、能量增進劑、抗出汗劑、收斂劑、毛髮生長增進劑、毛髮著色劑、顏料、固化劑、皮膚調理劑、以及如氣味遮蔽或pH變更劑之類的氣味控制劑。
在一實施例中,裝飾活性劑可為選自於由下列所述組成的群組,但不限於下列所述,包括羥基酸、苯甲醯基過氧化物、D-泛醇、甲氧基肉桂酸辛酯、二氧化鈦、辛基水楊酸鹽、胡莫柳酯、亞佛苯酮、類胡蘿蔔素、自由基清除劑、自旋捕捉劑、如維生素A酸(維甲酸)之類的類視色素和如維生素A與軟脂酸視網酯的類視色素前驅物、如維生素E(α、β或δ生育酚及/或其混合物)腦醯胺之類的維生素、多不飽和脂肪酸、基本脂肪酸、酶、酶抑制劑、礦物質、如黃體酮之類的激素、如氫化可體松之類的甾類、2-二甲氨基乙醇、如銅氯化物之類的金屬(包括但不限於鐵或鋅)鹽、如Cu:Gly-His-Lys之類的含銅胜肽、輔酶Q10、氨基酸、維生素、乙醯基輔酶A、菸醯酸、核糖黃素、硫胺素、核糖、如NADH與FADH2之類的電子傳遞劑、如蘆薈、小白菊、及大豆之類的植物性萃取物、以及衍生物及其混合物。裝飾活性劑於本發明之組成物中的用量,較佳為以重量計自約
0.001%至約20%的組成物,更較佳的是自約0.005%至約10%,以及更較佳的是自約0.01%至約5%。
在本發明的組成物及方法中同樣預期特別有效的是,合成或天然5-α還原酶抑制劑、或其它抗皮脂成分的存在,包括但不限於抗敏舒缓因子(Sepicontrol)(辛醯基甘氨基酸、肌胺酸及樟屬饅頭果皮萃取物)、甘草粉或萃取物、及類似物。MC5受體拮抗劑亦可利用於本發明之組成物中。MC5-R拮抗劑的實例可在美國第7,049,331號專利案中發現。
本發明的組成物,也可結合已知當作藥物,用於促進毛髮生長的化合物而予以利用,如非那雄胺(Propecia)、一第2類,5-α-還原酶抑制劑、及度他雄胺、一類型1-與2-5-α-還原酶抑制劑、及氟塔醯胺、白卡羅他邁、孕甾烷衍生物、黃體酮衍生物、如FCE 28260之類的實驗藥劑及類似物。在一些案例中,螺固內酯(spironolactone)與其他利尿劑亦可利用供婦女治療用(又名為安達通(Aldactone):一種醛固酮受體拮抗劑)。已知用於促進毛髮生長,如敏諾西迪(Minoxidil)(落健(Rogaine))之類的鉀離子通道開啟劑,亦咸信為格外看好的組合。
可具有5-α還原酶抑制作用的草藥可包括:沙巴棕(Saw Palmetto)及非洲腎果木(Pygeum africanum)。其它可具有此種活性的藥劑有β-谷固醇、抗敏舒缓因子與甘草、γ-亞麻脂酸以及其它不飽和脂肪酸(Tehming LIANG及Shutsung LIAO)Biochem.J.(1992)285,557-562、甾類5-α-還原酶藉由特定脂肪族不飽和脂肪酸的抑制作用)、鋅與鋅鹽、綠茶兒茶素(-)-表沒食子兒茶素沒食子酸酯(EGCG)和其
它多酚、及類似物。葡萄籽、蘋果籽、蘋果汁以及大麥萃取物也可為潛在藥劑,其可誘發毛髮生長,雖然一般認為其在達成令人滿意的成效方面並不是很常見或令人滿意(高橋等人(Takahashi et al.),原花青素低聚物選擇性且集中性地促進老鼠體外毛髮上皮細胞的增生和活化體內毛囊生長的作用,原刊於J投資皮膚科(J Invest Dermatol)112:310-316)。
額外的組合可包括其它已知的毛髮生長激活劑,如鋅、如FK506(他克莫司、藤霉素)之類的磷酸酵素抑制劑、一由筑波链霉菌產出的大環內酯類抗生素、及其衍生物、或環孢靈素A、一環十一氨基酸多肽及一T細胞特有免疫抑制劑、及類似物。
一種建議用於阻塞DHT的產品Provillus中的活性成分(維生素B6、生物素、鎂、鋅、沙巴棕、蕁麻、雷公根(Gotu Kola)、南瓜、刺五加根(Eleuthero Root)、熊果(Uva-Ursi)、巴西榥榥木)也可含括在本發明的組成物中。
可為本發明組成物成分之維生素的實例包括,但不限於維生素A、如維生素B3、維生素B5、及維生素B12等維生素B群、維生素C、維生素K、如α、γ或δ-生育酚等維生素E、以及衍生物(如鹽和酯)及其混合物。
羥基酸之實例包括但不限於乙醇酸、乳酸、蘋果酸、水楊酸、檸檬酸及酒石酸。咸信此類羥基酸起支援頭皮角質層再生的作用。我們亦相信此類羥基酸有助於正常化本發明組成物的pH,並且正如乳酸,可將一調理功效添加至毛髮。
可利用於本發明組成物及方法之抗氧化劑的實例,包括但不限於水可溶抗氧化劑,如氫硫基化合物及其衍生物(如偏二亞硫酸鈉及N-乙醯基半胱胺酸)、硫辛酸及二氫硫辛酸、白藜蘆醇、乳鐵蛋白,以及抗壞血酸和抗壞血酸衍生物(如棕櫚酸抗壞血酸酯和抗壞血酸多肽)。適用於本發明組成物的油可溶性抗氧化劑包括,但不限於二丁(基)羥基甲苯、類視色素(例如:視網醇及視網酯軟脂酸)、不同類型的生育酚(例如:α-、γ-、與δ-生育酚及其酯類,如醋酸酯)及其混合物、生育三烯醇、以及泛醌。適用於本發明組成物的含抗氧化劑天然萃取物包括,但不限於含有下列所述的萃取物,包括類黃酮、類異黃酮、及其如金雀異黃酮和大豆黃酮之類的衍生物(例如:含有白藜蘆醇之萃取物及類似物之大豆與三葉草萃取物)。此類天然萃取物之實例包括葡萄籽、綠茶、松樹皮及蜂蠟。
另一方面,黃體酮、以及具有擬黃體酮活性的天然衍生成分也可有用,收斂劑也是一樣,如金縷梅酊劑、三氯沙、淺藍菌素、α-亞甲基-γ-丁內酯,如辛醯甘氨酸和甲(基)甘胺酸之類的甘氨基酸衍生物、水楊酸、或苯甲醯基過氧化物。
具有下列活性成分的髮寶101(Fabao 101)也可包括於本發明的組成物中:楤木屬五葉地錦(Aralia Quinquetolia)、黃耆甘草葉 (Astragalus Glycyphyllos)、圓葉當歸(Angelica Arhangelica)根((Angelica Arhangelica)、鼠尾草(Salvia Officinalis)、辣椒(Capsicum)、核仁(Carya Alba)、紅花(Corthamis Tinctorius)、白鲜皮(Cortex dictamni radicis)、芙
蘿絲(Flos)菊花、何首烏(Heshouwu)、鐵拳參(Iron-Fist Ginseng)、丹參(Miltiorrhizae)、三七(Notoginseng)、補骨脂(Paorulca Glandulosa)、桃仁油(Peach Kernel Oil)、四川川芎根莖(Rhizome of Szechuan Lovage)、黃耆(Radix astragali)、人參(Radix Ginseng)、何首烏(Radix Polygoni Multiflori)、紅根鼠尾草屬(Red-rooted Salvia)、天麻參(Rhizhoma gastrodia ginseng)、羌活(Seu radix notopterygii)、苦參(Sophera flavescens).
各種其他材料亦可存於可用於本發明之組成物中。這些包括保濕劑、蛋白質與多肽、防腐劑以及一鹼性劑。此類藥劑的實例係揭露於INCI手冊的第1650至1667頁。本發明之組成物亦可包含螯合劑(例如:EDTA)及防腐劑(例如:對羥苯甲酸)。適合防腐劑以及螯合劑的實例,係列示於INCI手冊的第1626以及1654至55頁。另外,在本文中可用的局部組成物,可含有習知的裝飾佐藥,如染料、不透明劑(例如:二氧化鈦)、顏料、以及香水。
在一實施例中,本發明的組成物進一步含有如黑色素或合成黑色素衍生物、或擬黑色素分子之類的暗化劑、香草醛聚合物、天然萃取物,如但不限於錦紫蘇(Coleus Forskoli)萃取物、Bugrane-P萃取物、來自含顏料天然來源(例如:棕色顏料,其來自植物薑花屬或熊葡萄(熊果)屬或黃色、
橙色及紅色顏料,其來自含有類胡蘿蔔素或斑螯黃質的植物)的萃取物;或合成化學品,如含銅化合物(例如:銅鹽,如CuCl2)或合成類胡蘿蔔素或角黃素(canthaxantins)。合成黑色素衍生物的實例係在美國第5,618,519、5,384,116、以及5,227,459號專利案中提出。可溶黑色素衍生物的實例係在第5,744,125、5,225,435、5,218,079、以及5,216,116號中提出。市售可溶黑色素衍生物的實例,包括美國紐約San-mar laboratories公司(San-mar laboratories,Inc.(Elmsford,N.Y.))產製的Melasyn-100TM以及英國肯特Zylepsis公司(Ashford,Kent,United Kingdom)產製的MelanZeTM。
這些藥劑存於組成物的用量較佳的是自約0.001至約10重量%,尤其是一自約0.01至約5重量%的用量。
在另一實施例中,組成物可包括一胜肽。暗化胜肽的實例係在美國第7,025,951號專利案中提出。本發明所提的胜肽可以裝飾性可接受鹽的形式來提供。較佳鹽的實例係具有下列酸類的鹽:治療可接受的有機酸(例如:醋、棕櫚、油、硬脂、乳、順丁烯二、檸檬、蘋果、抗壞血、琥珀、苯甲、水楊、甲基磺、或棕櫚酸(Palmoic acid))、及如單寧酸或羧甲纖維素之類的聚合酸,以及具有如氫鹵酸(例如:氫氯酸)、硫酸或磷酸之類無機酸的鹽。
存於組成物中胜肽的用量取決於使用的胜肽。胜肽存於組成物的用量應該是自約0.001至約10重量%,尤其是一自約0.005至約5重量%的用量。
本發明的組成物可使用一礦水予以製備,例如已自然礦化的礦水,如法國Evian®依雲天然礦泉水(Evian® Mineral Water(Evian,France))。在一實施例中,礦水具有一至少約200mg/L(例如:自約300mg/L至約1000mg/L)的礦化作用。在一實施例中,礦水包含至少約10mg/L的鈣及/或至少約5mg/L的鎂。
本發明的組成物可用於在身體上希望毛髮生長的區域,局部塗敷所述組成物而誘發毛髮生長。較佳的是,本發明的組成物係局部塗敷於身體希望的區域,至少五(5)天,每天至少一次,並且更較佳的是每天施用,至少六週,以及最佳的是無限期施用。針對髮質的改善,所述組成物應至少十二週每天至少塗敷一次。在約兩週後,使用者可開始觀察毛髮生長增加,並且可能夠觀察毛幹直徑增加、及/或如髮卷、毛髮光澤及毛髮厚度之類的毛髮可見屬性增進。
一凝膠基質式A1係根據底下表1予以製備:下列成分係組合於一混合容器內:DI水、EDTA二鈉、甘油、二甲聚矽氧烷(單矽康)以及二丁(基)羥基甲苯(BHT),並且加熱至40至45℃,同時以中至高速(平鏟)使用螺旋式混合並且予以混合直到均勻。一旦達到一低於40℃的溫
度,將以螺旋式混合一次一種地添加下列成分(平鏟、中速):聚丙烯醯胺聚合物(Sepigel 305)、抑菌劑(Phenonip XB)。以氫氧化鈉將pH調整至5.0。
一含有黑莓萃取物的組成物(A2)、以及一僅含有丁二醇與水的組成物(A3),係根據實例1中所提的步驟,以下列表2中所提的配方予以製備。
組成物E1及C係根據下列表3中的配方予以製備。創新性實例E1的製備,係藉由組合實例1的凝膠基質A1與實例2的黑莓萃取物組成物A2,以經由混合直到達成均勻,而產生一濃度25%的黑莓萃取物(一1:1比例的A1與A2)。因此,比較實例C1係藉由組合實例2的凝膠基質A1與A3予以製備。
以小鼠進入毛髮生長初期階段的百分率,作為一時間的函數(研究日子),來衡量C3H小鼠的毛髮生長誘發
年齡6至7週的C3H雌鼠係購自美國紐約Taconic Farms公司(Taconic Farms(Germantown,NY))。小鼠飼於適當大小之飼養籠,飼於12小時光照-12小時黑暗之光照週期環境控制室中,食物與水任飼供給。動物照護係以NIH出版編號85-23「實驗動物照護和使用指南(Guide for the Care and Use of Laboratory Animals)」為基準。研究開始前讓動物
們先適應環境一週。一旦所有小鼠毛髮週期已進入其延長靜止期/休止期(約50至60天長),則將其背部區域毛髮剔除約1.5×5cm(Wahl Clippers 8900 Series,Blade # 1086)。每組四隻雌鼠在剔毛時以2%誘發及維持用異氟醯及0.5L氧麻醉。除了E1(250mg/ml黑莓配方)外,治療組還包括一安慰劑(C1)、以及一未治療組(n=4)對天然毛髮生長引發起控制的作用、並且觀察安慰劑功效、以及200μl的試驗材料係每日對區域局部塗敷,一週五天(週一至週五)。以目視觀察在毛髮生長初期/活性生長階段第一批徵兆出現時及必要時拍攝影像。記錄一每天描述對小鼠進入毛髮生長初期(灰色皮膚)所作觀察的研究日誌。治療持續進行達約8週。
令人驚訝的是,黑莓局部治療(E1)在第8天以前,誘發所有C3H小鼠的毛髮生長。在使用相同的試驗模型,與一市售毛髮生長產品(購自Eckerd Pharmacy的男用5%通用敏諾西迪(Minoxidil)溶液)比較評估時,利用E1局部塗敷的誘發較快並且以一較高的發生率/反應率出現。以5%市售敏諾西迪(Minoxidil)治療的小鼠中,平均約63%在第6週以前進入毛髮生長初期(N=4個研究),有100%是在第4週以前(第29天),當中敏諾西迪(Minoxidil)表現最佳為一正控制。
因此,我們的結論是,與平均約63%小鼠(N=4個研究)在第6週以前進入毛髮生長初期、並且有100%是在第4週以前(第29天)、當中敏諾西迪(Minoxidil)表現最佳為一正控制的5%市售敏諾西迪(Minoxidil)相比較,以E1治療時,毛髮生長誘發較快並且以一較高發生率出現,以八(8)天導致一100%的反應率。
製備由Williams E介質(負型麩胺酸)、L-麩胺酸、二性霉素B、盤尼西林以及鍊黴素(由Gibco供應)組成的介質。製備一由黑莓萃取物及介質構成的儲備溶液。製備1:10連續稀釋的儲備溶液直到達成適當濃度。
人類末端毛囊係分離自新生臉部整容手術樣本。個別小囊係置入一以0.5ml介質填充之0.4um插件中的12個良集插件(well Falcon insert)細胞培養皿內。使用一w/v計算將治療加諸介質。每隔一天變更介質。在第0、1、3、5、7&9天拍攝影像。影像分析係藉由測量毛幹長度而完成。計算各組平均及增長百分比。
相較於未用黑莓萃取物的小囊生長介質,0.001%(w/v)黑莓萃取物能夠提升63.65%毛幹加長。
人類毛囊係分離自新生臉部整容手術樣本。個別小囊係置入以2.0mL介質填充之0.4μm插件上的6個良隼插件細胞培養皿內。製備如實例5的介質以及一儲備溶液。使用一w/v計算將治療加諸介質。每隔一天變更介質。在第0、1、3、5、7、及9天拍攝影像。影像分析係藉由測量毛幹長度而完成。計算各組平均及增長百分比。
相較於無黑莓萃取物的小囊生長介質,濃度範圍介於0.0001%至0.001%(w/v)的黑莓萃取物,能夠提升毛幹加長超過15%。應注意的是,出乎意料地,0.05%較高濃度範圍的黑莓萃取物,未提升毛幹加長。
底下的實施例係使用表7所提的配方製作:
在主容器內並且攪動出現漩渦測量水。藉由篩選篩分緩慢添加卡波姆(carbomer)-丙烯酸、環乙烷。混合物加熱直到溫度達55至60℃。製作一20%的氫氧化鈉溶液。用一20%氫氧化鈉溶液將pH調整至5.5到6,以中和卡波姆。停止加熱並且將混合物冷卻至45℃。在甘油基聚甲基丙烯酸鹽中,預混合麥芽糊精(40%)黑莓葉萃取物(60%)。利用攪拌,將麥芽糊精(40%)黑莓葉萃取物(60%)、甘油基聚甲基丙烯酸鹽糊劑添加至容器。黏度隨其添加而持續降低。用一20%的氫氧化鈉溶液將pH調整至5.5到6.0。利用攪拌,將苯氧乙醇(及)辛醯基乙二醇(及)山梨酸添加至燒杯(配方C12具有苯氧乙醇及苯甲酸鈉)。用一20%的氫氧化鈉溶液將pH調整至5.5到6。搭配水進行QS。形成一凝膠。
E-2-一穩定凝膠形成、並且式通過13週穩度。穩度係以20 RPM使用一T形軸測試兩週及四週。樣本係保持在4℃、40℃及50℃的常溫。保持在50℃的樣本於六週自試驗取出,以及其它樣本(4℃及40℃的常溫)係於八週及13週讀取。一凍結/解凍試驗係進行三輪。
隨著添加更多(40%)黑莓葉萃取物(60%),必須添加更多卡波姆(carbomer)。
C2-對於C2,進行相同步驟,例外的地方在於,脫氫黃原膠係以甘油預濕,並且利用攪拌緩慢添加至容器。麥芽糊精(40%)黑莓葉萃取物(60%),未以甘油基聚甲基丙烯酸鹽預濕。所添加的防腐劑為苯氧乙醇以及苯甲酸鈉。
C3-對於C3,進行相同步驟,例外的地方在於,將水添加至容器後,進行加熱直到溫度達55至60℃。利用攪拌30分鐘,緩慢添加甲基纖維素及羥基丙基甲基纖維素。未以甘油基聚甲基丙烯酸鹽預濕麥芽糊精(40%)黑莓葉萃取物(60%)。將其直接噴灑至容器。
C4及C5-對於C4及C5,進行相同步驟,例外的地方在於,聚丙醯胺(及)C13-14異烷烴(及)月桂醇聚醚-7係後加至組成物。
C6-對於C6,進行相同步驟,例外的地方在於,聚丙烯酸鈉(及)氫化聚癸烯係在水中噴灑。聚丙醯胺(及)C13-14異烷烴(及)月桂醇聚醚-7係後加至式。
C7、C8及C9-對於C7、C8及C9,進行相同步驟,另外在丁二醇中預濕脫氫黃原膠。持續混合並且緩慢添加鋰鎂鈉矽酸鹽。注意到的是,隨著更多合成鋰皂石添加至組成物,稠度變得更接近一糊劑,與變為一凝膠截然不同)。
Claims (8)
- 一種增進毛髮生長的方法,其係藉由將一局部活性組成物塗敷於一患者的頭皮、皮膚、睫毛、眉毛、髭部位或鬍鬚部位,該組成物包含一濃度至少90mg萃取物/ml溶液、但小於300mg/ml的一黑莓(Rubus fruticosus)萃取物,其在每日塗敷至少七天後,增加頭皮的毛髮覆蓋。
- 如申請專利範圍第1項之方法,其中該組成物包含一濃度至少120mg/ml、但小於300mg/ml的黑莓萃取物。
- 如申請專利範圍第1項之方法,其中該組成物包含一濃度至少250mg/ml、但小於300mg/ml的黑莓萃取物。
- 一種用於增進毛髮生長的局部組成物,其包含一至少90mg/ml、小於300mg/ml的黑莓萃取物。
- 一種用於增進毛髮生長的局部組成物,其包含一至少120mg/ml、小於300mg/ml的黑莓萃取物。
- 一種用於增進毛髮生長的局部組成物,其包含一至少250mg/ml、小於300mg/ml的黑莓萃取物。
- 如申請專利範圍第4項之局部組成物,其中該組成物進一步包含護膚劑,該護膚劑由維生素、礦物質、蛋白質、胜肽、脂肪酸、抗氧化劑、抗發炎劑、暗化劑、植物性萃取物及其混合物所組成。
- 一種用於在患者的頭皮、皮膚、睫毛、眉毛、髭部位或鬍鬚部位上增進毛髮生長的組成物,該組成物包含一濃度至少90mg萃取物/ml的溶液、但小於300mg/ml的黑莓(學名Rubus fruticosus)萃取物,以及該組成物重量至少1%的卡波姆(carbomer)。
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