CN114796000A - 一种齐墩果酸的微乳化组合物及其制备方法和应用 - Google Patents
一种齐墩果酸的微乳化组合物及其制备方法和应用 Download PDFInfo
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- CN114796000A CN114796000A CN202210594122.2A CN202210594122A CN114796000A CN 114796000 A CN114796000 A CN 114796000A CN 202210594122 A CN202210594122 A CN 202210594122A CN 114796000 A CN114796000 A CN 114796000A
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Abstract
本发明属于化妆品技术和皮肤外用制剂技术领域,具体公开了一种齐墩果酸的微乳化组合物及其制备方法和应用。其中,所述微乳化组合物包含:齐墩果酸、表面活性剂、助表面活性剂、植物精油、水、环糊精、水溶性壳聚糖衍生物,并进一步包含固体脂质和/或优选的促生发物质(羽扇豆醇、异欧前胡素、淫羊藿素),以及其他辅料或添加剂。所述微乳化组合物可自乳化形成齐墩果酸处于溶解状态并且含量较高的微乳液或纳米乳液,还可进一步制备纳米结构脂质载体。本发明的微乳化组合物克服了齐墩果酸溶解性差和不易吸收的缺点,同时克服植物精油不稳定、不溶于水的缺陷,增强了有效性和稳定性,制备方法简单,适合工业化生产,有广阔的应用前景。
Description
技术领域
本发明属于化妆品技术领域和皮肤外用制剂技术领域,尤其是涉及一种齐墩果酸微乳化组合物及其制备化妆品和皮肤外用制剂的用途。
背景技术
齐墩果酸(Oleanolic acid)是一种天然的五环三萜类化合物,在植物中广泛存在。齐墩果酸提纯后的粉末为白色结晶,无臭,无味,对酸、碱不稳定,不溶于水。
齐墩果酸具有广泛的活性作用,除了抗菌、抗炎、抗氧化、保肝、抗肿瘤等作用,近年来一些体外研究显示了齐墩果酸对皮肤、毛囊还具有诸多功效:已证实齐墩果酸对皮肤有促进胶原蛋白生成、促进神经酰胺生成、促进伤口愈合、抗过敏等功效;并且已证实齐墩果酸体外促进毛囊生长、延长生长期和促进黑色素生成。预期使用齐墩果酸用于改善或预防皮肤或毛囊不良状况的产品,例如护肤、抗老化、生发、乌发产品的用途具有极高的开发前景。
目前缺乏齐墩果酸在化妆品领域或外用制剂领域的开发利用。齐墩果酸不溶于水,并且细胞渗透性差,属于低溶解性、低渗透性物质,限制了齐墩果酸的应用。
已公开的有关齐墩果酸的制剂专利仍存在一些问题阻碍规模化的工业化生产和应用,如齐墩果酸含量低、齐墩果酸添加量高但不处于溶解状态、涉及对人类皮肤或健康有害的有机溶剂或加工步骤复杂、制剂稳定性差、生产成本高等。
比如,专利CN112190610A公开了一种载齐墩果酸等植物活性成分的脂质体的制备方法,其中齐墩果酸溶解于pH为8.5到9.0的磷酸缓冲液中,然而根据公开文献,pH为9的磷酸盐缓冲液中齐墩果酸的溶解度仅有10μg/ml,当齐墩果酸添加较多时,大部分以非溶解的悬浮形式存在,只有极少量为溶解状态。并且齐墩果酸对酸碱不稳定,弱碱性的磷酸盐缓冲液不利于齐墩果酸的稳定。此外,脂质体有贮存稳定性差、载药量低、生产成本高、制备方法复杂的缺点。
选择合适的溶剂和制剂对提高齐墩果酸的溶解度和生物利用度至关重要,因为只有溶解并渗透吸收的成分才能发挥作用。然而齐墩果酸在大多数溶剂中溶解性不佳,根据已有文献报道和实验测试数据,以下是常用的齐墩果酸溶剂,及其溶解度以及是否为中国《化妆品安全技术规范》(2015年版)禁用原料。
在符合化妆品安全技术规范的前提下,通过使用以上溶剂很难获得齐墩果酸溶解量大于0.5%的产品,并且这些溶剂在高添加量下使用存在有安全性风险。而且所获得的溶液剂在皮肤上的使用感非常不好,无法被消费者接受。为了迎合市场和消费者需求,开发一种齐墩果酸处于溶解状态、含量较高、稳定性好并且适合工业化生产的化妆品或外用制剂显得尤为重要。
本发明开发出一种齐墩果酸外用的微乳化组合物,其包含植物精油,该组合物在克服齐墩果酸的溶解和渗透性差的困难的同时还解决了植物精油在应用上的难题。植物精油在局部应用可提供抗菌、抗炎、抗氧化、抗痤疮、抗衰老、亮肤特性,以保持皮肤年轻、健康和清新。此外,它们可以帮助促进毛囊中的血液循环和减少头屑、出油,从而对头发头皮产生益处,并促进头发密度的增加。然而,所有精油都是不稳定的挥发性化合物,易于降解(通过氧化、挥发、加热和光照),并且不溶于水。为了解决齐墩果酸和植物精油的这些问题,本发明利用微乳液或纳米结构脂质载体以增强其稳定性、溶解性和功效的发挥。
微乳液又称纳米乳液,定义为由油相与表面活性剂、助表面活性剂和水组成的乳液体系,特别地,诸如O/W纳米乳液或微乳液的细乳液由于其透明或略微半透明外观、并且制备工艺简单而在化妆品和皮肤外用制剂产品中是特别令人感兴趣的。
微乳液具有透明性,低粘度,热力学稳定性,使其成为有效的经皮和局部药物或化妆品递送系统;并且容易制备,只要处方选择适当,就能自发形成微乳。而且,与其他纳米载体如脂质体相比,它们具有一些实质性的优势,包括使用的表面活性剂较少、更高稳定性和更高载药量。微乳液还可进一步加入赋形剂,例如凝胶或软膏基质制备成微乳凝胶或软膏等,使之具有更加明显的缓释作用。
本发明进一步开发了以齐墩果酸微乳液为基质制备纳米结构脂质载体的微乳化组合物和制备方法。纳米结构脂质载体(NLC)是一种新型的纳米脂质载体,属于脂质纳米粒的一种,已应用于不同领域,特别是用于皮肤和透皮递送。纳米结构脂质载体与微乳同样由脂质、表面活性剂和助表面活性剂组成,区别在于微乳的油相为液体脂质,纳米结构脂质载体的油相为固体和液体脂质的混合物。NLC作为载体,结合了微乳和脂质体的特点,通过向固体脂质中加入化学性质差异较大的液态油,使乳滴以结晶缺陷型或无定型结构存在,增加了缓释性,增加了辅料对活性成分的包容性,避免了放置过程中的泄漏,有助于活性功效的充分发挥。
发明内容
本发明提供了一种微乳化组合物及制备方法及应用。
本发明要解决的技术问题之一在于提供一种齐墩果酸为溶解状态的微乳化组合物,它使用化妆品和皮肤外用制剂中可用的齐墩果酸溶剂作为助表面活性剂,再配合其他化妆品和皮肤外用制剂中可用的植物精油,表面活性剂和水以及其他辅料,形成溶解性比单纯使用齐墩果酸溶剂更好的齐墩果酸处于溶解状态并且含量较高的组合物。
本发明要解决的技术问题之二在于基于上述微乳化组合物提供一种微乳液或纳米乳液组合物和纳米脂质载体组合物,所述组合物在提高齐墩果酸和植物精油在水中的溶解性与经皮吸收能力的同时,克服植物精油不稳定、易降解(通过氧化、挥发、加热和光照)、不溶于水的缺陷:齐墩果酸增强植物精油稳定性,此外包含环糊精及水溶性壳聚糖衍生物的水相以水包油形式的微乳或纳米脂质载体搭载植物精油和齐墩果酸,阻止植物精油与空气接触,缓释性和稳定性进一步提高。
本发明要解决的技术问题之三在于提供一种齐墩果酸为溶解状态的微乳液(或纳米乳液)组合物和以该微乳液为基质进一步得到纳米结构脂质载体的制备方法,能实现比常规手段更好的技术效果并且制备工艺简单。
为了解决上述技术问题,本发明采用如下技术方案:
一方面,本发明提供一种齐墩果酸的微乳化组合物,由以下组分组成:齐墩果酸或其衍生物、表面活性剂、助表面活性剂、植物精油、水、环糊精、水溶性壳聚糖衍生物。
进一步地,所述微乳化组合物为水包油微乳液或纳米乳液组合物。
进一步地,所述微乳化组合物还包含固体脂质,所述组合物为纳米脂质载体组合物。
进一步地,所述微乳化组合物中,齐墩果酸或其衍生物的质量百分比为0.01%~10%,进一步地,所述齐墩果酸的质量百分比为0.1%~5%。进一步地,所述表面活性剂的质量百分比为1%~40%,进一步地,所述表面活性剂的质量百分比为4%~25%。进一步地,所述助表面活性剂的质量百分比为1%~40%,进一步地,所述助表面活性剂的质量百分比为4%~25%。进一步地,所述植物精油的质量百分比为0.4%~20%,进一步地,所述植物精油的质量百分比为1%~8%。进一步地,所述水的质量百分比为10~90%,进一步地,所述水的质量百分比为40%~90%。进一步地,所述环糊精的质量百分比为0~4%,进一步地,所述环糊精的质量百分比为0.5%~1%。进一步地,所述水溶性壳聚糖衍生物的质量百分比为0~4%,进一步地,所述水溶性壳聚糖衍生物的质量百分比为0.5%~1%。
进一步地,本发明中所述的表面活性剂,包括至少一种非离子表面活性剂或非离子表面活性剂与阴离子表面活性剂,阳离子表面活性剂和两性离子表面活性剂中的一种或多种的组合。
进一步地,所述表面活性剂选自以下的一种或多种:聚氧乙烯失水山梨醇脂肪酸酯(吐温类)、聚氧乙烯蓖麻油、聚氧乙烯氢化蓖麻油、辛酸/癸酸聚乙二醇甘油酯、失水山梨醇脂肪酸酯、聚氧乙烯甘油酯、脂肪醇聚氧乙烯醚(AEO)、鲸蜡硬脂醇聚醚、烷基糖苷、蔗糖脂肪酸酯,硬脂醇聚醚、油醇聚醚、磷脂类、氢化卵磷脂、卵磷脂、聚乙二醇脂肪酸酯、油酰聚氧乙烯甘油酯、聚甘油脂肪酸酯、甘油硬脂酸酯柠檬酸酯、辛酸钠、胆汁酸及其盐、熊果脱氧胆酸、胆酸钠、脱氧胆酸钠、牛磺胆酸钠、维生素E聚乙二醇琥珀酸酯、二棕榈酰基磷脂酰乙醇胺、二硬脂酰基磷脂酰乙醇胺、泊洛沙姆类、油酸聚乙二醇甘油酯、司盘80、鲸蜡醇磷酸酯钾、椰油酰谷氨酸二钠、椰油酰胺丙基甜菜碱、十二烷基硫酸钠、月桂基钠、月桂酰谷氨酸钠、椰油酰谷氨酸钠、肉豆蔻酰谷氨酸钠、椰油酰甘氨酸钾、棕榈酰甘氨酸。
进一步地,所述表面活性剂为以下的一种或多种:聚氧乙烯氢化蓖麻油、聚氧乙烯蓖麻油、脂肪醇聚氧乙烯醚(AEO-9)、吐温80、吐温20、辛癸基葡糖苷、卵磷脂;
进一步地,所述表面活性剂包含至少一种带负电的表面活性剂,所述带负电的表面活性剂选自辛癸基葡糖苷或卵磷脂。
进一步地,所述助表面活性剂为以下的一种或多种:二乙二醇单乙醚、聚丙二醇、甘油聚醚-26、甘油聚醚-18、乙二醇单苄醚、乙二醇苯醚、异山梨醇二甲醚、1,3-丁二醇、异戊二醇、甘油、丙二醇、1,2-戊二醇、二丙二醇、1,2-己二醇、乙二醇、乙醇、1,3-丁二醇、聚丙二醇;
进一步地,所述助表面活性剂为二乙二醇单乙醚、甘油聚醚-26、甘油聚醚-18、氮酮、乙二醇单苄醚、异戊二醇、异山梨醇二甲醚中的一种或多种,或与1,3-丁二醇、甘油、丙二醇、二丙二醇、1,2-戊二醇、1,2-己二醇、聚乙二醇、乙醇中的一种或多种的组合;
进一步地,所述助表面活性剂为二乙二醇单乙醚、甘油聚醚-26、异山梨醇二甲醚中的一种或多种,或与二丙二醇、异戊二醇、聚乙二醇中的一种或多种的组合;
进一步地,所述植物精油选自尤加利精油、薄荷精油、茶树精油、薰衣草精油、快乐鼠尾草精油、丁香精油、柏木精油、侧柏精油、天竺葵精油、柠檬草精油、雪松精油、桉叶油、鼠尾草精油、冬青精油、迷迭香精油、茴香精油、洋甘菊精油、愈创木精油、小茴香精油、罗勒精油、樟脑精油、卡南加精油、香茅精油、肉桂精油、生姜精油、紫苏精油、玫瑰精油、广藿香精油、檀香木精油、月桂精油、香叶精油、胡萝卜籽精油、佛手柑精油、葡萄柚精油、柠檬精油、柑桔精油、橙花精油、牛至精油、甜橙精油、依兰精油、丝柏精油、乳香精油、没药精油、蜡菊精油、百里香精油、荆芥精油、艾叶精油、茉莉精油、连翘精油、白芷精油、蛇床子精油、莪术精油、当归精油、川芎精油、麝香精油、羌活精油、姜黄精油、肉豆蔻精油、香薷精油、黑胡椒精油、芫荽精油、白松香精油、山苍子精油中的一种或多种,但不限于此。
在本发明的实施例中,当植物精油既是液体脂质载体和溶剂又是活性成分时可提供新颖的效用和/或优点,在应用中发挥协同作用。植物精油具有许多有价值的特性,包括抗菌,防腐,抗炎,芳香、收敛和再生的特性,可用于芳香疗法,改善或预防头皮屑,湿疹,痤疮,脂溢性皮炎等皮肤不良状况;在预期的应用中植物精油可作为齐墩果酸的渗透促进剂并作为活性成分例如通过改善局部血液循环来促进头发的再生,发挥多方面的功效协同作用。
进一步地,所述植物精油选自迷迭香精油、雪松精油、薄荷精油、茶树精油、薰衣草精油、快乐鼠尾草精油、尤加利精油、侧柏精油中的一种或多种;
进一步地,所述微乳化组合物按重量百分比计包含如下组分中的至少2种:迷迭香精油0.5~2.4%、雪松精油0.2~2%、薄荷精油0.5~3%、、茶树精油0.6~2.8%、薰衣草精油0.2~2.4%、快乐鼠尾草精油0.5~1.6%、尤加利精油0.5~2.8%、侧柏精油0.2~2.4%。
发明人惊奇地发现,优选的植物精油作为齐墩果酸的溶剂并作为液体脂质载体替代传统油相使用的动植物来源的脂肪酸或其衍生物解决了齐墩果酸溶解性差和皮肤吸收差的问题。
在本发明的实施例中,所述组合物中植物精油与助表面活性剂和表面活性剂在合适的比例下组合对齐墩果酸溶解度的进一步改善是特别关键的,并且对所述组合物能否自乳化形成微乳以及具备长期稳定性也是特别关键的。
进一步地,所述微乳化合物中所述表面活性剂与所述助表面活性剂的质量之和与所述植物精油的质量比是1:1到40:1,进一步地,所述微乳化合物中所述表面活性剂与所述助表面活性剂的质量之和与所述植物精油的质量比是5:1到16:1。进一步地,所述微乳化合物中表面活性剂与所述助表面活性剂的质量比为1:4到4:1,进一步地,所述微乳化合物中表面活性剂与所述助表面活性剂的质量比为1:2到2:1,进一步地,所述微乳化合物中表面活性剂与所述助表面活性剂的质量比为1:1。
进一步地,所述水选自蒸馏水、纯净水和/或去离子水,优选蒸馏水。
进一步地,所述环糊精选自α-环糊精,β-环糊精,γ-环糊精,及包括羟丙基-β-环糊精,磺丁基醚-β-环糊精,羟乙基-β-环糊精,二甲基-β-环糊精,三甲基-β-环糊精,二乙基β-环糊精等在内的环糊精衍生物;较佳为羟丙基-β-环糊精。
进一步地,所述微乳化组合物还包括环糊精,环糊精可选自α-环糊精,β-环糊精,γ-环糊精,及包括羟丙基-β-环糊精,磺丁基醚-β-环糊精,羟乙基-β-环糊精,二甲基-β-环糊精,三甲基-β-环糊精,二乙基β-环糊精等在内的环糊精衍生物。
在本发明的实施例中,环糊精优选水溶性高的羟丙基-β-环糊精。
在本发明的实施例中,羟丙基-β-环糊精稳定的微乳化组合物显示出所需的特性,例如增加活性成分溶解度、稳定性、生物利用度、安全性、减少皮肤刺激和吸附气味分子的能力。
进一步地,所述微乳化组合物还包括水溶性壳聚糖衍生物,水溶性壳聚糖衍生物可选自羧甲基壳聚糖、羟丙基壳聚糖、酰化壳聚糖、壳聚糖盐酸盐、壳聚糖季铵盐,优选羧甲基壳聚糖、羟丙基壳聚糖。
在本发明的实施例中,水溶性壳聚糖衍生物能直接溶解于水相,相比原型壳聚糖难溶于水、需要稀酸才能溶解的缺点,水溶性壳聚糖衍生物避免了稀酸的使用,从而避免稀酸降低齐墩果酸稳定性和引起皮肤刺激性的缺点。
在本发明的实施例中,水溶性壳聚糖衍生物具有优良的抗菌性、增稠性、保湿性、分散性、乳化性、稳定性、成膜性、凝胶性等特性;水溶性壳聚糖应用于美容化妆品中具有皮肤调理性能好、保湿性好、易成膜、防止皮肤干裂、粗糙及老化、加速伤口愈合、增强有效成分的透皮吸收、加速表皮细胞的代谢和再生能力的功能;应用于美发化妆品中由于其本身的带电性,使其具有抑制静电荷的蓄积与中和负电荷的作用,这可以减少脱发;此外,水溶性壳聚糖对头发具有良好的亲和性,能在头发表面形成一层有润滑作用的覆盖膜,是理想的固发剂和头发调理剂。
进一步地,所述微乳化组合物为水包油型微乳液或纳米乳液的形式,其按重量百分比计包含如下组分:齐墩果酸0.1%~2%、表面活性剂4%~25%、助表面活性剂4%~25%、植物精油1%~8%、水40%~90%、环糊精0.5%~1%、壳聚糖水溶性衍生物0.2~1%、常规辅料适量。进一步地,所述表面活性剂为以下的至少两种:聚氧乙烯氢化蓖麻油、吐温60、吐温20、辛癸基葡糖苷。进一步地,所述助表面活性剂为以下的一种或多种:二乙二醇单乙醚、异山梨醇二甲醚、二丙二醇、1,2-己二醇;进一步地,所述植物精油为以下至少2种:迷迭香精油、雪松精油、薄荷精油、茶树精油、薰衣草精油、快乐鼠尾草精油、尤加利精油;进一步地,所述水为蒸馏水或去离子水;进一步地,所述环糊精为羟丙基-β-环糊精;进一步地,所述水溶性壳聚糖为羧甲基壳聚糖或羟丙基壳聚糖;
进一步地,所述微乳化组合物还包含固体脂质,所述固体脂质可选自鲸蜡硬脂醇、十六烷基棕榈酸酯、硬脂酸、单硬脂酸甘油酯、二硬脂酸甘油酯、石蜡、鲸蜡醇棕榈酸酯、三棕榈酸甘油酯、氢化椰油甘油酯、蜂蜡、胆固醇、山嵛酸甘油酯、羊毛脂、凡士林、棕榈酰硬脂酸甘油酯中的一种或多种,但不限于此。
进一步地,所述固体脂质在微乳化组合物中的质量百分比为0%~5%。
进一步地,所述包含固体脂质的微乳化组合物为纳米结构脂质载体组合物。
进一步地,所述微乳化组合物包含固体脂质为单硬脂酸甘油酯和蜂蜡(质量比为2:1),所述固体脂质在组合物中优选的质量百分比为0.4%~1%。
在本发明的实施例中,植物精油替代传统的油脂类成分作为微乳载体或纳米结构脂质载体的液体脂质,使载体对植物精油的负载能力更高,使亲脂相可以溶解更多齐墩果酸,并且避免腐败。
进一步地,在本发明的实施例中,还包含一种或多种促生发物质。
进一步地,所述促生发物质为5α-还原酶抑制剂、雄激素受体拮抗剂、植物雌激素、血管舒张剂、植物提取物中的一种或多种;
优选地,所述5α-还原酶抑制剂可选自羽扇豆醇、红景天苷、月见草苷、杨梅素、小檗碱、山奈酚、女贞苷、槲皮素、染料木素、核黄素、姜黄素、染料木黄酮、豆甾醇、菜油籽醇、β-谷甾醇、表儿茶素、茶多酚、表没食子儿茶素没食子酸酯(EGCG)、表儿茶素没食子酸酯(ECG)、红花黄色素、锯棕榈提取物、壬二酸、锌、大黄素、油酸、亚油酸、亚麻酸、月桂酸、肉豆蔻酸、鹰嘴豆芽素A、度他雄胺、非那雄胺的至少一种;
优选地,所述雄激素受体拮抗剂可选自异欧前胡素、前胡素、欧前胡素、黄芩苷、厚朴酚、丁香酚、丹参酮、隐丹参酮、苦参碱、丹皮酚、木犀草素、6,7-呋喃香豆素、萝卜硫素、萝卜硫苷中的至少一种;
优选地,所述植物雌激素选自补骨脂酚、补骨脂素、毛蕊异黄酮、金雀异黄酮、槲皮素、蛇床子素、芹菜素、大豆异黄酮、葛根素、黄芩素、芒柄花素、白藜芦醇、松果菊苷、芦丁、羽扇豆醇、蜕皮甾酮、染料木黄酮、羟基红花黄色素A、熊果酸、桦木酸、桦木醇、山楂酸中的至少一种;
优选地,所述血管舒张剂选自淫羊藿素、淫羊藿苷、异欧前胡素、欧前胡素、腺苷、咖啡因、薄荷醇、雪松醇、辣椒素、松果菊苷、川芎甙、橄榄苦苷、烟酸、米诺地尔、吡咯烷基二氨基嘧啶氧化物、西地那非中的至少一种;
优选地,所述促生发的植物提取物,选自羽扇豆提取物、何首乌提取物、二苯乙烯苷、荨麻提取物、女贞子提取物、红花提取物、侧柏提取物、迷迭香提取物、三七提取物、余甘子提取物、茶叶提取物、积雪草提取物、獐牙菜提取物、当归提取物、松树皮提取物、接骨木提取物、奥斯曼草提取物、甘草提取物、白芷提取物、地黄提取物、油橄榄叶提取物、灵芝提取物、葛根提取物、透骨草提取物、丹参提取物、姜黄提取物、枇杷叶提取物、南瓜籽油、白鲜皮提取物、西洋参提取物、人参提取物、人参皂苷、三七皂苷、桑葚提取物、灵芝提取物、苦参提取物、蒲公英提取物、槐米提取物,楤木提取物、红景天提取物、补骨脂提取物、黄芪提取物、黄芩根提取物、黄柏提取物、莲子提取物、肉苁蓉提取物、淫羊藿提取物、川芎提取物、南瓜籽油、生姜提取物、黑芝麻提取物、菟丝子提取物、墨旱莲提取物、大黄提取物、桑叶提取物、羌活提取物、独活提取物、前胡提取物、山茱萸提取物、牛膝提取物、知母提取物、西兰花提取物中的至少一种,但不限于此。
特别优选地,所述促生发物质为选自羽扇豆醇、异欧前胡素、淫羊藿素中的至少2种。
其中,羽扇豆醇可作为植物来源的5α-还原酶抑制剂、植物雌激素、雄激素受体抑制剂,从而可保护毛囊免受雄激素的攻击,从而促进头发再生;
本发明还克服了羽扇豆醇在大多数溶剂中溶解性差的缺点,羽扇豆醇和齐墩果酸同属于五环三萜类化合物,具有相似的分子结构和化学性质,在本发明中的微乳化组合物中同样得到溶解性的极大提高;
此外,异欧前胡素作为一种新型的植物来源的雄激素受体拮抗剂,可竞争性抑制雄激素与其受体的结合,保护毛囊免受雄激素的攻击;异欧前胡素可抑制电压依赖性钙离子通道抑制剂,可作为血管舒张剂,促进头发生长;
淫羊藿素不仅具有植物雌激素作用,还是一种磷酸二酯酶5(PDE5)抑制剂,可增加细胞内环鸟苷单磷酸(cGMP)的水平,从而引起血管舒张,增加毛囊血液养分的供给,促进毛发再生。
特别优选地,所述微乳化组合物进一步包括如下质量百分比的促生发物质:羽扇豆醇0.01%~1%、异欧前胡素0.1%~5%、淫羊藿素0.1%~1.5%。
进一步地,所述微乳化组合物还包含其它辅料或添加剂,选自润肤剂/液体脂质、增稠剂、保湿剂、抗过敏剂、抗氧化剂、营养剂、pH调节剂、螯合剂、稳定剂、防腐剂、调理剂、紫外线吸收剂、去屑剂、染色剂或其他合适的辅料。
进一步地,所述微乳化组合物可包含润肤剂,并作为植物精油之外的液体脂质;所述润肤剂/液体脂质包括但不限于油酸乙酯、辛酸葵酸甘油酯、肉豆蔻酸异丙酯、棕榈酸异丙酯、亚油酸甘油酯、聚氧乙烯油酸甘油酯、甘油辛酸酯、丙二醇脂肪酸酯、矿物油、油酸、蓖麻油、氢化蓖麻油、霍霍巴油、椰油、杏仁油、乳木果油、玫瑰果油、葡萄籽油、摩洛哥坚果油、大豆油、玉米油、葵花油、芝麻油、红花油、胡萝卜籽油、橄榄油、鸸鹋油、维生素E、聚二甲基硅氧烷醇,二甲基硅油、亚油酸乙酯、异辛酸十六醇酯、异硬脂酸异丙酯硬脂基醚、己酸、辛酸、辛酯异链烷烃、硬脂酸乙基己酯、角鲨烷、辛基十二烷醇中的一种或多种。
优选地,所述润肤剂/液体脂质选自辛酸葵酸甘油酯、甘油辛酸酯、蓖麻油、霍霍巴油、葡萄籽油、椰油、硅油、异辛酸十六醇酯中的一种或多种,但不限于此。
所述增稠剂选自卡波姆、纤维素类、改性淀粉类、黄原胶、阿拉伯胶、瓜尔胶、聚季铵盐Q-10、聚丙烯酸、聚丙烯酸酯中的一种或多种,但不限于此。
所述保湿剂选自透明质酸钠、神经酰胺、甘草酸二钾、黄芪多糖、聚丙二醇、山梨醇、麦芽糖醇、芦荟胶、乳酸钠等中的一种或多种,但不限于此。
所述螯合剂选自依地酸二钠(EDTA二钠)、EDTA四钠、EDTA中的一种或多种,但不限于此。
所述防腐剂可选自对羟基苯乙酮、苯氧乙醇、苯甲酸、辛甘醇、尼泊金甲酯、尼泊金乙酯、尼泊金丙酯、尼泊金丁酯、二甲基氨基乙醇、苯扎氯铵、苯扎溴铵中的一种或多种,但不限于此。
所述抗氧化剂选自抗坏血酸磷酸酯镁、抗坏血酸磷酸酯钠、抗坏血酸乙基醚、谷胱甘肽、维生素E醋酸酯、没食子酸月桂酯、没食子酸丙酯、咖啡酸苯乙酯、亚硫酸氢钠中的一种或多种,但不限于此。
所述抗过敏剂选自没药醇、尿囊素、洋甘菊提取物、甘草酸、粉防己提取物、甘草次酸、甘草酸二钾中的一种或多种,但不限于此。
所述稳定剂可选自海藻酸盐、壳聚糖、壳寡糖、甲壳素、羟丙基甲基纤维素、丙基甲基纤维素、乙基纤维素、石墨烯、富勒烯、羟甲基氨基多糖、硫酸甘露聚糖、硫酸葡聚糖、多聚甘氨酸中的一种或多种,但不限于此。
所述营养剂选自赖氨酸,胱氨酸,精氨酸,蛋氨酸,胶原蛋白,生物素,角质素,软骨素,多肽,碱性成纤维细胞生长因子(bFGF)、自体生长因子(PRP)、锌、辅酶Q10、维生素A、B1、B2、B6、E、C、D等中的一种或多种,但不限于此。
所述pH调节剂选自柠檬酸、苹果酸、乳酸、乙酸、磷酸、三乙醇胺、氢氧化钠;所述微乳化组合物的pH值为6-8,较佳为7。
作为一种优选地可实施方式,所述微乳化组合物包括如下质量百分比的添加剂或辅料:润肤剂/液体脂质0.1%~2%、增稠剂0.1%~2%、保湿剂0.5%~2%、螯合剂0.01%~0.5%、抗氧化剂0.1%~2%、pH调节剂0.01%~0.5%。
进一步地,本发明的另一目的在于提供所述微乳化组合物的应用。
本发明的组合物优选地被局部使用,尤其是皮肤或头发护理产品,例如用于面部、身体皮肤或头发的护理。
根据本发明的一方面,提供了一种上述微乳化组合物或上述化妆品或外用制剂应用于预防或改善脱发、毛发稀疏、头发干枯毛躁、白发,促进毛发生长、乌发,和/或改善皮肤老化、皱纹、皮肤脱色、脂溢性皮炎、痤疮,预防皮肤物理屏障损伤或其他不健康的皮肤状况的化妆品或皮肤外用制剂的用途。
根据本发明的另一方面,提供了一种化妆品或皮肤病学制剂,以微乳液或纳米乳液、纳米结构脂质载体或微乳/纳米脂质载体复合物的形式提供。
进一步地,所述微乳化组合物在水溶液中的平均粒径为10~1000nm。
进一步地,所述微乳化组合物还可包含化妆品上或皮肤病学上可接受的基质,可使用的形式包括凝胶剂、软膏、霜剂、乳剂、泡沫、喷雾、洗剂、擦剂、贴剂、涂剂、脂质纳米粒、脂质体、微球、控释剂、育发液、头发营养液、护发精华液、发蜡、护发素、发膜、睫毛膏、胡子生长液、发油、护发剂、乌发剂、染发剂、洗发剂、美发剂、发胶、摩丝、护肤精华液、护肤凝胶、抗老化制剂、眼霜、肌底液、护肤精油、精华乳、化妆水、爽肤水、痤疮水、乳液、香波、啫喱、香水中的一种,但不限于此。
当本发明的剂型为软膏、糊剂、霜或凝胶时,作为载体成分,可使用动物油、植物油、蜡、石蜡、淀粉、纤维素衍生物、聚乙二醇、硅酮、膨润土、二氧化硅、滑石粉、氧化锌或者它们的混合物。
当本发明的剂型为喷雾剂时,作为载体成分,可使用乳糖、滑石粉、二氧化硅、氢氧化铝、硅酸钙、聚酰胺粉末或它们的混合物。
当本发明的剂型为乳剂时,作为载体成分,可使用水、乙醇或丙二醇等液体稀释剂。
根据本发明的微乳化组合物的制备工艺,组合物形成齐墩果酸微乳液(或纳米乳液)的过程中,可通过自发乳化实现,无需均质、高压或超声波处理。
进一步地,本发明的产品遇水形成齐墩果酸微乳化体系过程中,在自发乳化后,还使用均质处理、超声波处理或高压处理,设备的运行参数可根据实际需要任意调整。
进一步地,本发明提供了上述一种所述微乳化组合物即一种齐墩果酸微乳液或纳米乳液组合物的制备方法:
S1-1.称取助表面活性剂、植物精油和表面活性剂(磷脂除外),在容器A中混合搅拌均匀,随后加入配方量的齐墩果酸搅拌至完全溶解得到亲脂相;
S1-2.称取羟丙基-β-环糊精,加入在容器B中的水中溶解,随后加入水溶性壳聚糖衍生物搅拌至充分溶胀后得到水相;
S1-3.辅料、添加剂、促生发物质可依据溶解性任选地在水相或亲脂相中加入、混匀;
S1-4.将亲脂相边搅拌边缓慢加入容器B的水相中自乳化得到澄清透明的微乳初乳;
S1-5.磷脂(若有)加入容器B中,随后用高速均质机以转速18000rpm搅拌10-15分钟得微乳液或纳米乳液。
本发明不同于通常研究报道的微乳液或纳米乳液和制备工艺。本发明以植物精油替代传统的脂肪酸类液体脂质,使载体对植物精油的负载能力更高,使亲脂相可以溶解更多齐墩果酸,从而提高搭载齐墩果酸的能力;水相中包含具有表面活性作用的环糊精和水溶性壳聚糖衍生物,可以减少表面活性剂的使用;亲水性的带正电的水溶性壳聚糖衍生物能够自发地与带负电的烷基糖苷、卵磷脂等表面活性剂通过静电相互作用聚合在一起,增强乳化体系的稳定性。
进一步地,本发明还提供了上述一种所述微乳化组合物制备的微乳液(或纳米乳液)为基质,制备纳米结构脂质载体的方法:
S2-1.取适量容器B中制得的微乳液加入容器D中,加热至65-70℃并保持此温度;
S2-2.称取固体脂质和乳化剂泊洛沙姆(质量比1:1-1:4,优选为1:3)加入容器C中,加热至高于其熔点(65-70℃)直到获得透明熔体;
S2-3.将容器C中透明熔体以质量比1:100-1:20加入容器D中的微乳液搅拌混匀至得到澄清的热微乳液;
S2-4.热微乳液用高速均质机以转速18000rpm搅拌5分钟,以及超声波破碎仪以200-500W功率(较佳400W)处理10-20分钟后,热微乳液经冰水浴锅冷却得到纳米结构脂质载体。
本发明不同于通常研究报道的纳米结构脂质载体和制备工艺。纳米结构脂质载体为通过向固态脂质中加入与之化学性质差异很大的液态脂质,使乳滴以结晶缺陷型或无定型结构存在,常采用混合类脂为载体材料,将液态脂质混合到固体脂质中制备而得。纳米结构脂质载体的制备方法主要有融熔-乳化法、高压乳匀法、溶剂扩散法、薄膜分散-超声法等。本发明通过微乳作为载体,可以最大程度地将齐墩果酸包裹于液态脂质中,再通过热微乳的方法,加入合适比例的熔融的固体脂质和泊洛沙姆,使固体脂质和泊洛沙姆熔融后可自乳化混合于含齐墩果酸及植物精油的热微乳中,不改变表面活性剂与总脂质的比例从而具有良好稳定性,冷却后即得纳米结构脂质载体,制备工艺简单。
与现有技术相比,本发明的突出优点和技术效果在于:
1、本发明微乳液滴粒径小,透光性好,呈透明或半透明,解决传统乳剂粒径较大,热力学稳定性差的缺陷:显著提高了在水中的分散性;相比已公开的文献或专利技术,齐墩果酸在乳化体系中的溶解量也显著提高,在使用安全无害的溶剂的前提下实质性解决了齐墩果酸溶解量不足的问题,有利于齐墩果酸在化妆品和医药制剂的应用。
2、本发明的微乳化组合物为齐墩果酸在精油、表面活性剂和助表面活性剂等的共同作用下形成流动性好、透明或半透明、略带乳光的水包油型微乳或纳米结构脂质载体或其复合物的分散体系,植物精油为所述水包油型微乳和纳米结构脂质载体的液体脂质,并且优选的不包含传统的油脂类成分作为液体脂质,粘度低、带天然芳香,具有良好的感官性。
3、齐墩果酸的积极特性(即生理活性)与优选的具有良好的透皮吸收能力以及营养或活性效果的植物精油相结合,达到功效协同、优缺点互补的效果;优选的植物精油极大增强了齐墩果酸的溶解和经皮吸收,齐墩果酸稳定了植物精油并减缓其挥发;齐墩果酸有抗过敏功效,加上微乳化载体的缓释性,避免了部分精油的致敏性。
4、克服了植物精油不稳定、易降解(通过氧化、挥发、加热和光照)、不溶于水的缺陷:微乳化载体以水包油的形式包裹精油,阻止植物精油与空气接触,避免降解;微乳化载体的包封与环糊精及水溶性壳聚糖衍生物可以提供植物精油和齐墩果酸等活性成分的缓释性、提供植物精油更好的稳定性。
5、提高产品经皮吸收的能力:本发明的微乳化载体有利于功效成分的透皮吸收和发挥功效;优选的天然植物精油具有促渗作用,不需要添加化学促渗剂;载体具有缓释作用,使齐墩果酸和植物精油能够透过皮肤角质层屏障达到相应的作用部位、并在这些部位维持一定的效应时间。
6、提高产品防腐的能力,同时减少甚至不加防腐添加剂。齐墩果酸与植物精油、水溶性壳聚糖衍生物、环糊精和优选的助表面活性剂均有较强抑菌能力,抑菌谱互补,不添加化学防腐剂也能预防产品变质,使皮肤剌激性减少,安全性提高。
7、大多数助表面活性剂/溶剂与表面活性剂、促生发的植物提取物具有令人不愉快的气味,环糊精有吸附气味分子、除臭的作用,并且植物精油的芳香特性可以起到遮掩或消除不需要以及难闻性气味的功能,不需要再使用化学香料或除臭剂。
8、为了形成均一、稳定的体系,往往需要加较多表面活性剂进行乳化。而表面活性剂多为有机溶剂,可产生刺激性和油腻感。优选进一步加入的环糊精和水溶性壳聚糖衍生物在水相中相容性好,两者均有表面活性作用,增加了微乳液的液膜强度,加强了稳定性,减少表面活性剂的使用量,加强对精油的缓释作用,提高产品的安全性和使用体验。
9、开发了天然植物中存在的羽扇豆醇、异欧前胡素、淫羊藿素等物质作为新颖的生发活性成分并与齐墩果酸和植物精油联合应用,协同发挥并增强了减少脱发、促进生发等功效。
10、本产品制备工艺简单,利于环保。传统的乳液化妆品或外用医药制剂由于需要使用多种原料,其油相和水相成分复杂、添加剂多、工艺流程繁琐、生产周期较长,或为了提高齐墩果酸溶解量使用有毒有害的溶剂;本发明制备工艺简单,成分精简、成本低廉、易于工业化生产、溶剂安全、减少对环境的污染。
附图说明
图1表示实施例6中得到的纳米结构脂质载体的粒径分布。
图2表示实施例9中得到的微乳液的粒径分布。
具体实施方式
本发明公开了一种微乳化组合物,以及制备微乳液或纳米乳液与纳米结构脂质载体的制备方法。示例性的组合物仅是说明性的,并不限制本发明的范围。本领域技术人员可以借鉴本文内容,适当改进工艺参数实现。特别需要指出的是,所有类似的替换和改动对本领域技术人员来说是显而易见的,它们都被视为包括在本发明。本发明的产品及应用已经通过较佳实施例进行了描述,相关人员明显能在不脱离本发明内容、精神和范围内对本文所述的方法和应用进行改动或适当变更与组合,来实现和应用本发明技术。例如,以下给出的具体实施例中含有约50%左右的水,相关人员可以通过减少水或不使用水以及调整其余组分使齐墩果酸的含量提高一倍以上。
除非另有说明,否则实施例和说明书中其他部分的比例均以重量计。以下制剂是针对微乳液(或纳米乳液)、纳米脂质载体、凝胶的实施方式;但是,类似的技术也可以在其他类型的化妆品或洗护产品中使用该配方,包括但不限于洗发剂、凝胶剂、乳膏剂、霜剂、喷雾剂、护发素和定型产品。
实施例1:
一种齐墩果酸微乳液,包括以下重量百分比的各原料组分,如表1所示:
表1
制备方法:
S1-1.称取二丙二醇、乙醇、甘油聚醚-26、迷迭香精油、雪松精油和辛基葡糖苷、聚氧乙烯35蓖麻油,在容器A中混合搅拌均匀,随后加入配方量的齐墩果酸搅拌至完全溶解得到亲脂相;
S1-2.称取羟丙基-β-环糊精,加入在容器B中的水中溶解,随后加入羧甲基壳聚糖搅拌至充分溶胀后得到水相;
S1-3.将亲脂相边搅拌边缓慢加入水相中自乳化得到澄清透明的微乳初乳;
S1-4.卵磷脂加入容器B,随后用高速均质机以转速18000rpm搅拌10分钟得微乳液。
实施例2:一种齐墩果酸纳米结构脂质载体,包括实施例1各原料组分制备的微乳液成品和以下重量百分比的各原料组分:单硬脂酸甘油酯1.2%、蜂蜡0.8%、泊洛沙姆1885%。
制备方法:
S2-1.将实施例1制得的微乳液加入容器D中,加热至65-70℃并保持此温度;
S2-2.称取单硬脂酸甘油酯、蜂蜡和泊洛沙姆188加入容器C中,加热至65-70℃直到获得透明熔体;
S2-3.将容器C中透明熔体加入容器D中的微乳液搅拌混匀至得到澄清透明的热微乳液;
S2-4.热微乳液用高速均质机以转速18000rpm搅拌5分钟,以及超声波破碎仪以400W功率处理10-20分钟后,使用冰水浴锅冷却得到纳米结构脂质载体。
实施例3:
一种齐墩果酸微乳液,包括以下重量百分比的各原料组分,如表2所示:
表2
制备方法:
S1-1.称取异山梨醇二甲醚、异戊二醇、茶树精油、薄荷精油、侧柏精油和吐温20、脂肪醇聚氧乙烯醚(AEO-9)、癸基葡糖苷在容器A中混合搅拌均匀,随后加入配方量的齐墩果酸搅拌至完全溶解得到亲脂相;
S1-2.加入在容器B中加入适量水,随后加入羟丙基壳聚糖搅拌至充分溶胀后得到水相;
S1-3.将亲脂相边搅拌边缓慢加入水相中自乳化得到澄清透明的微乳初乳;
S1-4.随后用高速均质机以转速16000rpm搅拌12分钟得微乳液。
实施例4:一种齐墩果酸纳米结构脂质载体,包括实施例3各原料组分制备的微乳液成品和以下重量百分比的各原料组分:单硬脂酸甘油酯0.6%、硬脂酸0.2%、泊洛沙姆188 2%。制备方法参照实施例2。
实施例5:一种齐墩果酸微乳液,包括以下重量百分比的各原料组分,如表3所示:
表3
制备方法:
S1-1.称取二乙二醇单乙醚、1,3-丁二醇、1,2-己二醇、快乐鼠尾草精油、薰衣草精油、尤加利精油和聚氧乙烯40氢化蓖麻油、聚氧乙烯35蓖麻油、聚甘油单油酸酯、辛酸葵酸甘油酯、荷荷巴油,在容器A中混合搅拌均匀,随后加入配方量的齐墩果酸搅拌至完全溶解得到亲脂相;
S1-2.称取羟丙基-β-环糊精,加入在容器B中的水中溶解,随后加入羧甲基壳聚糖和透明质酸钠搅拌至充分溶胀后得到水相;
S1-3.将亲脂相边搅拌边缓慢加入水相中自乳化得到澄清透明的微乳初乳;
S1-4.随后用高速均质机以转速12000rpm搅拌10分钟得微乳液。
实施例6:一种齐墩果酸纳米结构脂质载体,包括实施例5各原料组分制备的微乳液成品和以下重量百分比的各原料组分:单硬脂酸甘油酯1.2%、蜂蜡0.2%、泊洛沙姆1885%。制备方法参照实施例4。
如图1所示,在实施例6中,选取对应的配方,制备出齐墩果酸纳米结构脂质体样品,并通过第三方测试机构测定了其平均粒径,结果表明该纳米结构脂质体平均粒径值为601nm。
实施例7:一种齐墩果酸微乳液,包括以下重量百分比的各原料组分,如表4所示:
表5
制备方法:
S1-1.称取配方量的茶树精油、迷迭香精油、尤加利精油、薄荷精油、快乐鼠尾草精油、异山梨醇二甲醚、二乙二醇单乙醚(Transcutol)、PEG400、苯氧乙醇、辛基葵基葡糖苷、吐温80在容器A中混合均匀,随后加入配方量的齐墩果酸、异欧前胡素、淫羊藿素搅拌至完全溶解得到亲脂相;
S1-2.称取羟丙基-β-环糊精加入在容器B中的水中溶解,随后加入羧甲基壳聚糖搅拌至充分溶胀后得到水相;
S1-3.将亲脂相边搅拌边缓慢加入容器B水相中自乳化得到澄清的微乳初乳;
S1-4.卵磷脂加入容器B,随后用高速均质机以转速18000rpm搅拌12分钟得微乳液。
实施例8:一种齐墩果酸微乳凝胶,包括以下重量百分比的各原料组分:实施例7制备好的微乳液适量,卡波姆940 0.5%和甘油5.5%,三乙醇胺溶液适量。
制备方法:在搅拌条件下,将卡波姆940和甘油缓慢加入上述制备好的齐墩果酸微乳,放置过夜使其自然溶胀后,滴加三乙醇胺溶液调节pH值约为6.8,随后用高速均质机以转速2000rpm搅拌10分钟。
实施例9:一种齐墩果酸微乳液,包括以下重量百分比的各原料组分,如表5所示:
表5
制备方法:
S1-1.称取配方量的茶树精油、迷迭香精油、尤加利精油、薄荷精油、快乐鼠尾草精油、雪松精油、异山梨醇二甲醚、甘油聚醚-26、二乙二醇单乙醚(Transcutol)、丙二醇、聚氧乙烯60氢化蓖麻油、辛基葵基葡糖苷、脂肪醇聚氧乙烯醚(AEO-9)在容器A中混合均匀,随后加入配方量的齐墩果酸、羽扇豆醇、异欧前胡素、淫羊藿素搅拌至完全溶解得到亲脂相;
S1-2.称取羟丙基-β-环糊精加入在容器B中的水中溶解,随后加入羧甲基壳聚糖和透明质酸钠搅拌至充分溶胀后得到水相;
S1-3.将亲脂相边搅拌边缓慢加入水相中自乳化得到澄清的微乳初乳.
S1-4.随后用高速均质机以转速16000rpm搅拌12分钟得微乳液。
如图2所示,在实施例9中,选取对应的配方,制备出齐墩果酸微乳液样品,并通过第三方测试机构测定了其平均粒径,结果表明该微乳液平均粒径值为593nm。
对比例1:一种齐墩果酸微乳液,包括实施例9除齐墩果酸、羽扇豆醇、异欧前胡素、淫羊藿素之外的各原料组分和重量百分比,制备方法参照实施例9。
对比例2:一种齐墩果酸微乳液,包括实施例9除羽扇豆醇、异欧前胡素、淫羊藿素之外的各原料组分和重量百分比,制备方法参照实施例9。
试验例1:齐墩果酸防脱生发效果实验
招募80名年龄在18~55岁之间的雄激素脱发男性志愿者测试使用本发明产品,分为四组各20人,第一组使用普通市售育发产品,第二组使用本发明对比例1,第三组使用本发明对比例2,第四组使用本发明实施例9。使用方法为早晚各一次,每次用棉签蘸取1ml,涂于脱发处并按摩2分钟。
选取一块固定的头皮区域进行测试,为期6个月。分别在试验初始期、试验3个月时和试验6个月时对该头皮区域进行头发密度统计测试,头发密度=头发占比面积/选取头皮面积,得到的测试结果如下表7
表7:
结果:依照测试结果表7显示,在分别使用本发明产品和某市售产品3个月和6个月之后,使用本发明产品的志愿者在测试部位头发密度的改善情况均明显优于市售产品,发量明显增加,齐墩果酸联合植物精油的头发密度的改善情况优于单独的植物精油更优于普通市售产品,实施例9的齐墩果酸与植物精油在联合促生发物质羽扇豆醇、异欧前胡素、淫羊藿素后头发密度进一步改善。试验结束后各组耐受性良好,均未出现皮肤发红或出现红斑等过敏现象。
试验例2稳定性考察
1)离心加速试验对微乳稳定性影响
取本发明实施例1、例9制备的微乳液,以20000r/min离心,15min后观察微乳液外观均保持澄清透明,未出现油水分层现象。
2)光稳定性试验
将本发明实施例1、例9的微乳液适量装入玻璃瓶内,密封后(5000±500)lx光照条件下室温放置,分别于1d、3d、7d取样观察。结果表明,微乳液均保持澄清透明外观,未见分层和破乳等现象。
3)留样观察试验
将本发明实施例1、例9的微乳液分装于玻璃瓶内,密封后分别置于4℃、25℃、40℃条件下留样考察6个月,每隔14d取样观察。结果表明,微乳液在此四种温度条件下均保持澄清透明外观,未见分层和破乳等现象。
上述实施例仅为本发明的较佳实施例,不能被认为用于限定本发明的实施范围。凡依本发明申请范围所作的均等变化与改进等,均应仍归属于本发明的专利涵盖范围之内。
Claims (10)
1.一种齐墩果酸的微乳化组合物,所述微乳化组合物为水包油形式的微乳液或纳米乳液组合物,其特征在于:按重量百分比计包含如下组分:齐墩果酸或其衍生物0.01%~10%、表面活性剂1%~40%、助表面活性剂1%~40%、植物精油0.4%~20%、水10~90%、环糊精0~4%、水溶性壳聚糖衍生物0~4%,以及活性化合物、其他辅料或添加剂适量;
其中,所述的表面活性剂为非离子表面活性剂,阴离子表面活性剂,阳离子表面活性剂和两性离子表面活性剂中的一种或多种的组合;所述的非离子表面活性剂为以下一种或多种:烷基糖苷、聚氧乙烯蓖麻油、聚氧乙烯氢化蓖麻油、聚氧乙烯失水山梨醇脂肪酸酯、卵磷脂、氢化卵磷脂、辛酸/癸酸聚乙二醇甘油酯、脂肪醇聚氧乙烯醚、聚甘油脂肪酸酯、泊洛沙姆类;
所述助表面活性剂为二乙二醇单乙醚、甘油聚醚-26、甘油聚醚-18、氮酮、乙二醇单苄醚、异戊二醇、异山梨醇二甲醚、1,3-丁二醇、甘油、丙二醇、二丙二醇、1,2-戊二醇、1,2-己二醇、聚乙二醇、乙醇中的一种或多种的组合;
所述植物精油为以下的一种或多种:薄荷精油、茶树精油、薰衣草精油、尤加利精油、快乐鼠尾草精油、丁香精油、柏木精油、侧柏精油、天竺葵精油、柠檬草精油、雪松精油、桉叶油、鼠尾草精油、冬青精油、迷迭香精油、茴香精油、洋甘菊精油、小茴香精油、罗勒精油、樟脑精油、卡南加精油、香茅精油、肉桂精油、生姜精油、紫苏精油、玫瑰精油、广藿香精油、檀香木精油、月桂精油、香叶精油、佛手柑精油、葡萄柚精油、柠檬精油、柑桔精油、牛至精油、依兰精油、丝柏精油、蜡菊精油、百里香精油、当归精油、艾叶精油、白芷精油、蛇床子精油、川芎精油、姜黄精油;
所述水选自蒸馏水、纯净水和/或去离子水;
所述环糊精选自α-环糊精,β-环糊精,γ-环糊精,及包括羟丙基-β-环糊精,磺丁基醚-β-环糊精,羟乙基-β-环糊精,二甲基-β-环糊精,三甲基-β-环糊精,二乙基β-环糊精在内的环糊精衍生物;
所述水溶性壳聚糖衍生物选自羧甲基壳聚糖、羟丙基壳聚糖、酰化壳聚糖、磷酸酯化壳聚糖、硫酸酯化壳聚糖、壳聚糖盐酸盐、壳聚糖季铵盐;
所述表面活性剂与所述助表面活性剂的质量之和与所述植物精油的质量比是1:1到20:1;
所述表面活性剂与所述助表面活性剂的质量比为1:4到4:1。
2.如权利要求1所述的微乳化组合物,其特征在于:所述微乳化组合物为水包油形式的微乳液或纳米乳液组合物,按重量百分比计包含如下组分:齐墩果酸0.1%~5%、表面活性剂4%~25%、助表面活性剂4%~25%、植物精油1%~8%、水40%~90%、环糊精0.5%~1%、水溶性壳聚糖衍生物0.2~1%;
所述表面活性剂为聚氧乙烯氢化蓖麻油、聚氧乙烯蓖麻油、脂肪醇聚氧乙烯醚、吐温80、吐温20中的至少一种与辛癸基葡糖苷、卵磷脂中的至少一种的组合;
所述助表面活性剂为二乙二醇单乙醚、甘油聚醚-26、异山梨醇二甲醚中的一种或多种,或与二丙二醇、异戊二醇、聚乙二醇中的一种或多种的组合;
所述植物精油为以下的一种或多种:迷迭香精油、雪松精油、薄荷精油、茶树精油、薰衣草精油、快乐鼠尾草精油、尤加利精油、侧柏精油;
所述水为蒸馏水或去离子水;
所述环糊精为羟丙基-β-环糊精;
所述水溶性壳聚糖为羧甲基壳聚糖或羟丙基壳聚糖;
所述表面活性剂与所述助表面活性剂的质量之和与所述精油的质量比是5:1到16:1;
所述表面活性剂与所述助表面活性剂的质量比是1:2到2:1。
3.一种微乳化组合物,其特征在于:所述微乳化组合物为纳米结构脂质载体组合物,在权利要求1或2的微乳化组合物的基础上进一步包含固体脂质;所述固体脂质选自鲸蜡硬脂醇,十六烷基棕榈酸酯,硬脂酸,单硬脂酸甘油酯,二硬脂酸甘油酯,鲸蜡醇棕榈酸酯,三棕榈酸甘油酯,氢化椰油甘油酯,蜂蜡,胆固醇,山嵛酸甘油酯,棕榈酰硬脂酸甘油酯中的一种或多种;所述固体脂质在微乳化组合物中质量百分比为0.1~5%。
4.如权利要求3所述的微乳化组合物,其特征在于:所述微乳化组合物包含的固体脂质为单硬脂酸甘油酯和蜂蜡,所述固体脂质在微乳化组合物中的质量百分比为0.4%~1%。
5.如权利要求1所述的微乳化组合物,其特征在于:所述活性化合物为促生发物质;
所述促生发物质选自5α-还原酶抑制剂、雄激素受体拮抗剂、植物雌激素、血管舒张剂、植物提取物中的至少一种;
所述5α-还原酶抑制剂选自羽扇豆醇、红景天苷、月见草苷、杨梅素、小檗碱、山奈酚、女贞苷、槲皮素、染料木素、核黄素、姜黄素、染料木黄酮、豆甾醇、菜油籽醇、β-谷甾醇、表儿茶素、茶多酚、表没食子儿茶素没食子酸酯、表儿茶素没食子酸酯、红花黄色素、锯棕榈提取物、壬二酸、锌、大黄素、油酸、亚油酸、月桂酸、亚麻酸、肉豆蔻酸、鹰嘴豆芽素A、非那雄胺、度他雄胺中的至少一种;
所述雄激素受体拮抗剂选自异欧前胡素、前胡素、欧前胡素、黄芩苷、厚朴酚、丁香酚、丹参酮、隐丹参酮、苦参碱、丹皮酚、木犀草素、萝卜硫素、萝卜硫苷中的至少一种;
所述植物雌激素选自补骨脂酚、补骨脂素、毛蕊异黄酮、金雀异黄酮、槲皮素、蛇床子素、芹菜素、大豆异黄酮、葛根素、黄芩素、芒柄花素、白藜芦醇、松果菊苷、芦丁、羽扇豆醇、蜕皮甾酮、染料木黄酮、羟基红花黄色素A中的至少一种;
所述血管舒张剂选自淫羊藿素、淫羊藿苷、异欧前胡素、欧前胡素、腺苷、咖啡因、薄荷醇、雪松醇、辣椒素、松果菊苷、川芎甙、橄榄苦苷、烟酸、米诺地尔中的至少一种;
所述促生发的植物提取物,选自选自羽扇豆提取物、何首乌提取物、二苯乙烯苷、荨麻提取物、女贞子提取物、红花提取物、侧柏提取物、迷迭香提取物、三七提取物、余甘子提取物、茶叶提取物、积雪草提取物、獐牙菜提取物、当归提取物、松树皮提取物、接骨木提取物、奥斯曼草提取物、甘草提取物、白芷提取物、地黄提取物、油橄榄叶提取物、灵芝提取物、葛根提取物、透骨草提取物、丹参提取物、姜黄提取物、枇杷叶提取物、南瓜籽油、白鲜皮提取物、西洋参提取物、人参提取物、人参皂苷、三七皂苷、桑葚提取物、灵芝提取物、苦参提取物、蒲公英提取物、槐米提取物,楤木提取物、红景天提取物、补骨脂提取物、黄芪提取物、黄芩根提取物、黄柏提取物、莲子提取物、肉苁蓉提取物、淫羊藿提取物、川芎提取物、南瓜籽油、生姜提取物、黑芝麻提取物、菟丝子提取物、墨旱莲提取物、大黄提取物、桑叶提取物、羌活提取物、独活提取物、前胡提取物、山茱萸提取物、牛膝提取物、知母提取物、西兰花提取物中的至少一种。
6.如权利要求5所述的微乳化组合物,其特征在于:所述的微乳化组合物包含的促生发物质为羽扇豆醇、异欧前胡素、淫羊藿素中的至少一种,所述促生发物质在微乳化组合物中优选的质量百分比为羽扇豆醇0.01%~2%、异欧前胡素0.1%~5%、淫羊藿素0.1%~1.5%。
7.如权利要求1所述的微乳化组合物,其特征在于:所述的其它辅料或添加剂选自润肤剂/液体脂质、增稠剂、保湿剂、抗氧化剂、营养剂、pH调节剂、螯合剂、稳定剂、防腐剂、调理剂、紫外线吸收剂、抗过敏剂、去屑剂中的一种或多种;
所述润肤剂/液体脂质选自辛酸葵酸甘油酯、甘油辛酸酯、蓖麻油、胡萝卜籽油、霍霍巴油、葡萄籽油、椰油、硅油、异辛酸十六醇酯中的一种或多种;
所述增稠剂选自卡波姆、纤维素类、改性淀粉类、黄原胶、阿拉伯胶 、瓜尔胶、聚季铵盐Q-10、聚丙烯酸、聚丙烯酸酯中的一种或多种;
所述保湿剂选自透明质酸钠、神经酰胺、甘草酸二钾、黄芪多糖、聚丙二醇、山梨醇、麦芽糖醇、芦荟胶、乳酸钠中的至少一种;
所述抗氧化剂选自抗坏血酸磷酸酯镁、抗坏血酸磷酸酯钠、抗坏血酸乙基醚、谷胱甘肽、维生素E醋酸酯、没食子酸月桂酯、没食子酸丙酯、咖啡酸苯乙酯、亚硫酸氢钠中的至少一种;
所述营养剂选自赖氨酸,胱氨酸,精氨酸,蛋氨酸,胶原蛋白,生物素,多肽,角质素,软骨素,锌,维生素A、B1、B2、B6、E、C、D中的至少一种;
所述稳定剂选自海藻酸盐、壳聚糖、壳寡糖、甲壳素、羟丙基甲基纤维素、丙基甲基纤维素、乙基纤维素、石墨烯、富勒烯中的至少一种;
所述防腐剂选自对羟基苯乙酮、苯氧乙醇、苯甲酸、辛甘醇、尼泊金甲酯、尼泊金乙酯、尼泊金丙酯、尼泊金丁酯、二甲基氨基乙醇、苯扎氯铵、苯扎溴铵中的一种或多种;
所述pH调节剂选自柠檬酸、苹果酸、乳酸、乙酸、磷酸、三乙醇胺中的至少一种;所述微乳化组合物的pH值为6-8。
8.如权利要求1-7任一项所述的微乳化组合物,其特征在于:所述微乳化组合物在制备用于预防或改善脱发、毛发稀疏、头发干枯毛躁、白发,促进毛发生长、乌发,和/或改善皮肤老化、皱纹、皮肤脱色、脂溢性皮炎、痤疮,预防皮肤物理屏障损伤的化妆品或皮肤外用制剂的用途。
9.如权利要求1-7任一项所述的微乳化组合物,其特征在于:该组合物的形式选自微乳液或纳米乳液、纳米结构脂质载体、微乳/纳米结构脂质载体复合物,所述组合物可进一步加入化妆品或皮肤病学上常用的外用制剂基质和/或水制备成凝胶剂、软膏、霜剂、乳剂、泡沫、喷雾、洗剂、擦剂、贴剂、涂剂、脂质纳米粒、脂质体、微球、微针、控释剂、育发液、头发营养液、护发精华液、发蜡、护发素、发膜、睫毛膏、胡子生长液、发油、护发剂、乌发剂、染发剂、洗发剂、美发剂、发胶、摩丝、护肤精华液、护肤凝胶、抗老化制剂、眼霜、肌底液、护肤精油、精华乳、化妆水、爽肤水、痤疮水、乳液、香波、啫喱、香水产品。
10.如权利要求1-7任一项所述微乳化组合物的制备方法,其特征在于:包括下述步骤:
(1)齐墩果酸微乳液或纳米乳液的制备:
S1-1.称取助表面活性剂、植物精油和磷脂除外的表面活性剂,在容器A中混合搅拌均匀,随后加入配方量的齐墩果酸搅拌至完全溶解得到亲脂相;
S1-2.称取羟丙基-β-环糊精,加入在容器B中的水中溶解,随后加入水溶性壳聚糖衍生物搅拌至充分溶胀后得到水相;
S1-3.辅料、添加剂、促生发物质依据溶解性任选地在水相或亲脂相中加入、混匀;
S1-4.将亲脂相边搅拌边缓慢加入容器B的水相中自乳化得到澄清透明的微乳初乳;
S1-5. 若有磷脂,则加入容器B中,随后用高速均质机以转速18000 rpm搅拌10-15分钟得微乳液;
(2)齐墩果酸纳米结构脂质载体的制备:
S2-1.取适量容器B中制得的微乳液加入容器D中,加热至65-70℃并保持此温度;
S2-2.按质量比1:1-1:4称取固体脂质和乳化剂泊洛沙姆加入容器C中,加热至高于其熔点直到获得透明熔体;
S2-3.将容器C中透明熔体以质量比1:100-1:20加入容器D中的微乳液搅拌混匀至得到澄清的热微乳液;
S2-4.热微乳液用高速均质机以转速18000 rpm搅拌5分钟,以及超声波破碎仪以200-500 W功率处理10-20 分钟后,热微乳液经冰水浴锅冷却得到纳米结构脂质载体。
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