CN116850073A - 一种活性物低共熔溶剂脂质体面霜及其制备方法 - Google Patents
一种活性物低共熔溶剂脂质体面霜及其制备方法 Download PDFInfo
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- CN116850073A CN116850073A CN202310751246.1A CN202310751246A CN116850073A CN 116850073 A CN116850073 A CN 116850073A CN 202310751246 A CN202310751246 A CN 202310751246A CN 116850073 A CN116850073 A CN 116850073A
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- China
- Prior art keywords
- eutectic solvent
- active substance
- liposome
- active
- water
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
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Classifications
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
- A61K8/14—Liposomes; Vesicles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
本发明提供一种活性物低共熔溶剂脂质体面霜及其制备方法，其基于活性物低共熔溶剂技术与超分子脂质体技术进行研发，将磷脂、胆甾醇、乳化剂在50‑75℃水浴温度下溶解，磁力搅拌混匀后，加入得到的油溶性活性物低共熔溶剂，搅拌混合制得油相；将稳定剂、保湿剂和纯水在50‑75℃水浴温度下溶解，加入水溶性活性物低共熔溶剂，搅拌均匀得到水相；将水相在剪切条件下缓慢加入油相，经高压均质处理得到活性物低共熔溶剂脂质体面霜。本发明稳定性高，面霜粒径小，肤感细腻清爽，制备方法简便，利于放大生产。
Description
技术领域
本发明属于化妆品技术领域，具体涉及一种活性物低共熔溶剂脂质体面霜及其制备方法。
背景技术
面霜在化妆品行业中占有巨大的份额，其构成主要是水包油(W/O)体系和油包水(O/W)两种体系。面霜的粒径分布不均匀，粒径由几百纳米到几十微米之间呈不均匀分布，膏霜的整体肤感参差不齐，且皮肤吸收能力差。大部分活性物由于其理化特征，大多会被皮肤屏障挡在角质层外，很难渗透进入皮肤深层发挥作用；部分活性物非常容易受外界环境影响，比如过渡金属离子、光照、pH、温度、高浓度氧气等，使其失去原有的功效。
低共溶溶剂(DESs)是一种由氢键受体和氢键供体一定化学计量比在一定条件下形成的低共熔混合物。DESs具有环境友好、生物降解性高、不可燃性、价廉和易制备等优点。天然低共熔溶剂(natural deep eutectic solvents，NDESs)的组分为天然产物，NDESs的毒性明显低于DESs，且在经济和环境角度上，NDESs的生物降解性、可持续性及制备成本均优于DESs。
脂质体技术，是指将生物活性物包埋于两亲性类脂分子所形成的磷脂双分子层结构内的封闭囊泡，与细胞膜结构类似，主要是由磷脂和胆固醇构成，又被称为人工生物膜。脂质体可以有效解决生物活性物的溶解度、稳定性、刺激性、气味、配方困难及生物利用度等问题。目前化妆品行业几乎都是将该技术运用于化妆品功效原料的开发，而不是化妆品成品配方。虽然该技术使化妆品功效成分的稳定性以及透皮吸收性大幅度提升，但是这类化妆品在应用到化妆品生产中时，容易受到生产工艺和产品的理化性质的影响，如剪切，过度金属离子，生产温度，产品pH值，从而破坏其本身的结构，影响活性物的透皮吸收以及稳定性。
发明内容
为了解决现有技术中的问题，本发明提供一种活性物低共熔溶剂脂质体面霜及其制备方法，不添加防腐剂，将超分子脂质体技术应用于化妆品成品配方中，有效提高其中各种活性物的皮肤中的滞留量，促进功效成分的渗透，降低环境因素对活性物的影响，改善面霜体系的整体肤感。
本发明解决其技术问题是采用以下技术方案实现的：
本发明第一个目的在于提供一种活性物低共熔溶剂脂质体面霜的制备方法，其特征在于，包括以下步骤：
1)活性物低共熔溶剂的制备：
精密称量活性物及其配体在40-100℃条件下加热溶解，搅拌混合均匀，冷却至室温，形成活性物低共熔溶剂，所述活性物低共熔溶剂包括油溶性活性物低共熔溶剂和水溶性活性物低共熔溶剂，分别制成油溶性活性物低共熔溶剂和水溶性活性物低共熔溶剂；
2)油相的制备：
将磷脂、胆甾醇、乳化剂在50-75℃水浴温度下溶解，磁力搅拌混匀，加入步骤1)得到的油溶性活性物低共熔溶剂，搅拌混合制得油相；
3)水相的制备：
将稳定剂、保湿剂和纯水在50-75℃水浴温度下溶解，磁力搅拌混匀，加入步骤1)得到的水溶性活性物低共熔溶剂，搅拌均匀得到水相；
4)面霜的制备：
将得到的水相在剪切条件下缓慢加入油相，得到初乳；然后将初乳经高压均质处理，循环4～16次；冷却至35～60℃，加入pH调节剂搅拌均匀，继续冷却至室温得到活性物低共熔溶剂脂质体面霜。
进一步的，所述活性物与配体的摩尔比为1:3-3:1。
优选的，所述活性物与配体的摩尔比为1:2-3:2。
进一步的，剪切条件为剪切转速为5000-10000rpm；剪切温度为50-75℃；剪切时间为3-8min。
进一步的，高压均质的条件为均质压力为500-1000bar；均质温度为50-75℃。
本发明第二个目的在于提供一种上述制备方法得到的活性物低共熔溶剂脂质体面霜，其特征在于，包括以下质量百分比组分：
活性物低共熔溶剂：1.5-12.0％
磷脂：1.0-5.0％
乳化剂：1.0-3.0％
胆甾醇：0.1-0.5％
保湿剂：5.0-15.1％
稳定剂：0.2-0.8％
pH调节剂：0-0.5％
纯水：余量；
所述活性物低共熔溶剂包括油溶性活性物低共熔溶剂和水溶性活性物低共熔溶剂。
进一步的，所述活性物低共熔溶剂选自以下至少一种：艾地苯醌薄荷脑、辅酶Q10薄荷脑、烟酰胺木糖醇、烟酰胺丙二醇、烟酰胺果糖、烟酰胺柠檬酸。
进一步的，所述磷脂选自大豆卵磷脂、氢化卵磷脂、溶血卵磷脂、蛋黄卵磷脂中的至少一种。
进一步的，所述乳化剂选自PEG-100硬脂酸酯、聚山梨醇酯-20、聚山梨醇酯-60、聚山梨醇酯-80、聚甘油-10-月桂酸酯、聚甘油-10-油酸酯、聚甘油-10-肉豆蔻酸酯、甘油硬脂酸酯、硬脂醇聚醚-21、鲸蜡硬脂基葡糖苷中的至少一种。
进一步的，所述保湿剂选自甘油、1,3-丙二醇、甘油葡糖苷、透明质酸钠、1，3-丁二醇、1,2-戊二醇、1,2-己二醇、乙基己基甘油、双丙甘醇、甘油葡糖苷中的至少一种。
进一步的，所述稳定剂选自EDTA-2Na、焦亚硫酸钠、生育酚、生育酚乙酸乙酯、卡波姆、聚丙烯酸酯交联聚合物-6中的至少一种。
进一步的，所述稳定剂为生育酚、生育酚乙酸乙酯时与磷脂、胆甾醇、乳化剂共同混合制备油相。
进一步的，所述pH调节剂选自氢氧化钠，氢氧化钾，三乙醇胺，精氨酸，乳酸，柠檬酸中的至少一种。
与现有技术相比，本发明的有益技术效果在于：
本发明将活性成分与与配体结合形成活性物低共熔溶剂，再与脂质体共载制备成活性物低共熔溶剂脂质体面霜，将活性物低共熔溶剂脂质体用于面霜成品中，得到的脂质体面霜稳定性高，粒径小，肤感细腻清爽。本发明全成分绿色安全，无防腐剂添加；能显著促进活性物透皮吸收，降低环境因素对活性物的影响。本发明面霜制备方法简单，利于工业化、规模化应用于化妆品中，具有广阔的应用价值。
上述说明仅是本发明技术方案的概述，为了能够更清楚了解本发明的技术手段，而可依照说明书的内容予以实施，并且为了让本发明的上述和其它目的、特征和优点能够更明显易懂，以下特举本发明的具体实施方式。
附图说明
图1为本发明一种超分子脂质体技术的面霜及其制备方法中实施例1与对比例1的外观对比图。
图2为本发明一种超分子脂质体技术的面霜及其制备方法中实施例1与对比例1的水分散对比图。
图3为本发明一种超分子脂质体技术的面霜及其制备方法中实施例1的透射电镜图。
图4-图11为本发明一种超分子脂质体技术的面霜及其制备方法中各实施例与对比例的样品粒径图。
图12为本发明一种超分子脂质体技术的面霜及其制备方法中各实施例的外观稳定性图。
图13为本发明一种超分子脂质体技术的面霜及其制备方法中实施例1的粒径稳定性图。
图14为本发明一种超分子脂质体技术的面霜及其制备方法中实施例1的包封率稳定性图。
图15-17为本发明一种超分子脂质体技术的面霜及其制备方法中实施例1与对比例1、实施例2与对比例2、实施例3与对比例3的活性物质含量稳定性对比图。
图18为本发明一种超分子脂质体技术的面霜及其制备方法中实施例1与对比例1、实施例2与对比例2、实施例3与对比例3的活性成分皮肤累计滞留量对比图。
图19为本发明一种超分子脂质体技术的面霜及其制备方法中实施例1与对比例1的肤感评价对比图。
图20为本发明一种超分子脂质体技术的面霜及其制备方法中实施例1与对比例1的皮肤弹性图。
图21为本发明一种超分子脂质体技术的面霜及其制备方法中实施例1与对比例1的皮肤紧致度图。
图22为本发明一种超分子脂质体技术的面霜及其制备方法中实施例1与对比例1的皮肤粗糙度测试图。
具体实施方式
以下结合附图和具体实施例对本发明技术方案作进一步详细说明。应当理解，下列实施例仅为示例性地说明和解释本发明，而不应被解释为对本发明保护范围的限制。凡基于本发明上述内容所实现的技术均涵盖在本发明旨在保护的范围内。
另外，除非另有特别说明，本发明中用到的各种原材料、试剂、仪器和设备均可通过市场购买获得或现有方法制备得到。
实施例1：0.5％艾地苯醌低共熔溶剂脂质体面霜
制备方法为：
(1)制备艾地苯醌活性物低共熔溶剂：精密称量摩尔比为1:2的艾地苯醌及薄荷脑，在55℃条件下加热溶解，搅拌混合均匀，冷却至室温，形成艾地苯醌薄荷脑低共熔溶剂；
(2)制备油相：将4.0g氢化卵磷脂、0.2g胆甾醇、2.0gPEG-100硬脂酸酯和甘油硬脂酸酯在75℃水浴温度下溶解，磁力搅拌混匀，加入上述得到的1.5g艾地苯薄荷脑低共熔溶剂并磁力搅拌混匀，制得油相，备用；
(3)制备水相：将0.2g卡波姆、0.1g EDTA-2Na、0.1g透明质酸钠、5g甘油、5g1，2-戊二醇、5g双丙甘醇和76.6g纯水在50℃水浴温度下溶解，磁力搅拌混匀，加热至75℃备用；
(4)高速剪切：将水相在剪切条件下缓慢加入油相，剪切转速为5000rpm，剪切温度为75℃，剪切时间为3min，即得初乳；
(5)高压均质：将初乳经高压均质处理，均质压力为500bar，均质温度为75℃，循环次数为5次，冷却至60℃，加入0.3g三乙醇胺，搅拌均匀，冷却至室温，即得0.5％艾地苯醌低共熔溶剂脂质体面霜。
实施例2：0.5％辅酶Q10低共熔溶剂脂质体面霜
制备方法为：
(1)制备辅酶Q10低共熔溶剂：精密称量摩尔比为1:2的辅酶Q10及薄荷脑，在50℃条件下加热溶解，搅拌混合均匀，冷却至室温，形成辅酶Q10薄荷脑低共熔溶剂；
(2)制备油相：将1.0g氢化卵磷脂、0.1g胆甾醇、1.0g聚甘油-10-月桂酸酯在75℃水浴温度下溶解，磁力搅拌混匀，加入上述1.5g辅酶Q10薄荷脑低共熔溶剂并磁力搅拌混匀，制得油相，备用；
(2)制备水相：将0.2g卡波姆、0.1g EDTA-2Na、0.1g透明质酸钠、5.0g甘油葡糖苷、5g1，2-戊二醇和85.9g纯水在50℃水浴温度下溶解，磁力搅拌混匀，加热至75℃备用；
(3)高速剪切：将水相在剪切条件下缓慢加入油相，剪切转速为5000rpm，剪切温度为75℃，剪切时间为3min，即得初乳；
(4)高压均质：将初乳经高压均质处理，均质压力为500bar，均质温度为75℃，循环次数为10次，冷却至60℃，加入0.1g氢氧化钠，搅拌均匀，冷却至室温，即得0.5％辅酶Q10低共熔溶剂脂质体面霜。
实施例3：5％烟酰胺活性物低共熔溶剂脂质体面霜
制备方法为：
(1)制备烟酰胺低共熔溶剂：精密称量摩尔比为1:1的烟酰胺及木糖醇，在100℃条件下加热溶解，搅拌混合均匀，冷却至室温，形成烟酰胺低共熔溶剂；
(2)制备油相：将4.0g氢化卵磷脂、0.2g胆甾醇、1g鲸蜡硬脂基葡糖苷在75℃水浴温度下溶解，磁力搅拌混匀，制得油相备用；
(3)制备水相：将0.15g卡波姆、0.05g EDTA-2Na、0.1g透明质酸钠、5g甘油、5g1，2-戊二醇、和74g纯水在50℃水浴温度下溶解，再加入10g烟酰胺低共熔溶剂，磁力搅拌混匀，制得水相；
(4)高速剪切：将水相在剪切条件下缓慢加入油相，剪切转速为10000rpm，剪切温度为75℃，剪切时间为3min，即得初乳；
(5)高压均质：将初乳经高压均质处理，均质压力为600bar，均质温度为75℃，循环次数为10次；冷却至60℃，加入0.5g三乙醇胺，搅拌均匀，继续降至室温即得5％烟酰胺低共熔溶剂脂质体面霜。
实施例4：4％烟酰胺低共熔溶剂脂质体面霜
制备方法为：
(1)制备烟酰胺果糖低共熔溶剂：精密称量摩尔比为1:2的烟酰胺及果糖，在100℃条件下加热溶解，搅拌混合均匀，冷却至室温，形成烟酰胺果糖低共熔溶剂；
(2)制备油相：将4.0g氢化卵磷脂、0.2g胆甾醇、0.5％生育酚乙酸乙酯、1g硬脂醇聚醚-21、2g鲸蜡硬脂基葡糖苷在75℃水浴温度下溶解，磁力搅拌混匀，加入上述得到的混合溶液并磁力搅拌混匀，制得油相，备用；
(3)制备水相：将0.2g聚丙烯酸酯交联聚合物-6、0.1g EDTA-2Na、5g1，2-戊二醇和75g纯水在50℃水浴温度下溶解，磁力搅拌混匀，再加入12g烟酰胺果糖低共熔溶剂，搅拌混合均匀，得到水相；
(4)高速剪切：将水相在剪切条件下缓慢加入油相，剪切转速为5000rpm，剪切温度为75℃，剪切时间为3min，即得初乳；
(5)高压均质：将初乳经高压均质处理，均质压力为800bar，均质温度为75℃，循环次数为8次，冷却至室温即得4％烟酰胺低共熔溶剂脂质体面霜。
实施例5：3％烟酰胺低共熔溶剂脂质体面霜
制备方法为：
(1)制备烟酰胺柠檬酸低共熔溶剂：精密称量摩尔比为1:1的烟酰胺及柠檬酸，在100℃条件下加热溶解，搅拌混合均匀，冷却至室温，形成烟酰胺柠檬酸低共熔溶剂；
(2)制备油相：将5.0g氢化卵磷脂、0.5g胆甾醇、2g聚山梨醇酯-80在75℃水浴温度下溶解，磁力搅拌混匀，制得油相，备用；
(3)制备水相：0.2g卡波姆、0.05g EDTA-2Na、0.1g透明质酸钠、5g甘油葡糖苷，6g丙二醇，4g1，2-戊二醇和67.97g纯水在50℃水浴温度下溶解，磁力搅拌混匀，加入9g烟酰胺柠檬酸低共熔溶剂，搅拌混合均匀，得到水相；
(4)高速剪切：将水相在剪切条件下缓慢加入油相，剪切转速为10000rpm，剪切温度为75℃，剪切时间为3min，即得初乳；
(5)高压均质：将初乳经高压均质处理，均质压力为700bar，均质温度为70℃，循环次数为8次；冷却至60℃，加入0.18g三乙醇胺，搅拌均匀，继续降至室温即得3％烟酰胺低共熔溶剂脂质体面霜。
对比例1：0.5％艾地苯醌面霜
制备方法为：
(1)制备油相：将0.5g艾地苯醌、2.0g PEG-100硬脂酸酯和甘油硬脂酸酯在75℃水浴温度下溶解，磁力搅拌混匀，备用；
(2)制备水相：将0.2g卡波姆、0.1gEDTA-2Na、0.5g对羟基苯乙酮、0.1g透明质酸钠、5.0g甘油和91.1g纯水在50℃水浴温度下溶解，磁力搅拌混匀，加热至75℃备用；
(3)高速剪切：将水相在剪切条件下缓慢加入油相，剪切转速为5000rpm，剪切温度为75℃，剪切时间为3min；
(4)冷却至60℃，加入0.3g三乙醇胺，搅拌均匀；降温至45℃，加入0.5％1,2-己二醇，搅拌均匀，冷却至室温，即得0.5％艾地苯醌面霜。
对比例2：0.5％辅酶Q10面霜
制备方法为：
(1)制备油相：将0.5g辅酶Q10、1.0g聚甘油-10-月桂酸酯、0.1g羟苯丙酯在75℃水浴温度下溶解，磁力搅拌混匀，备用；
(2)制备水相：将0.2g卡波姆、0.1g EDTA-2Na、0.2g羟苯甲酯、0.1g透明质酸钠、5.0g甘油和92.7g纯水在50℃水浴温度下溶解，磁力搅拌混匀，加热至75℃备用；
(3)高速剪切：将水相在剪切条件下缓慢加入油相，剪切转速为5000rpm，剪切温度为75℃，剪切时间为3min，即得初乳；冷却至60℃，加入0.1g氢氧化钠，搅拌均匀，冷却至室温，即得0.5％辅酶Q10面霜。
对比例3：5％烟酰胺面霜
制备方法为：
(1)制备油相：将1g硬脂醇聚醚-21、2g鲸蜡硬脂基葡糖苷在75℃水浴温度下溶解，磁力搅拌混匀，备用；
(2)制备水相：将5g烟酰胺、0.2g卡波姆、0.1g EDTA-2Na、0.1g透明质酸钠、5.0g1，3-丁二醇和85.6g纯水在50℃水浴温度下溶解，磁力搅拌混匀，加热至75℃备用；
(3)高速剪切：将水相在剪切条件下缓慢加入油相，剪切转速为5000rpm，剪切温度为75℃，剪切时间为3min，即得初乳；冷却至60℃，加入0.5g三乙醇胺，搅拌均匀；冷却至45℃，加入0.5g苯氧乙醇搅拌均匀，继续降至室温即得0.1％烟酰胺面霜。
实验例：
1、外观对比
本发明实施例1所得的活性物低共熔溶剂脂质体面霜和对比例2所得常规面霜的外观进行观察，如附图1所示，可以看出本发明实施例1制得的活性物低共熔溶剂脂质体面霜外观更加细腻柔亮。
2、水分散性对比
将本发明实施例1与对比例1得到的面霜用水稀释至相同的倍数，观察其分散情况，参见附图2，可以看出本发明实施例1的活性物低共熔溶剂脂质体面霜较常规面霜更易分散，且外观透明，有淡蓝色乳光。
3、透射电镜观察
将实施例1得到的活性物低共熔溶剂脂质体面霜用蒸馏水稀释后，用毛细管吸取样品吹于载网上，染色、清洗，待干燥后用透射电镜进行观察，并拍照记录，参见附图3，可以看出，活性物低共熔溶剂脂质体面霜粒径小且均匀。
4、粒径稳定性
将各实施例制得的活性物低共熔溶剂脂质体面霜及各对比例制得的普通面霜稀释后，用纳米粒度zeta电位分析仪(安东帕有限公司，Litesizer 500)进行粒径测定。
参见附图4-11及表1，可以看出，本发明活性物低共熔溶剂脂质体面霜粒径均一，PDI指数小于0.22，实施例5得到的活性物低共熔溶剂脂质体面霜的PDI指数达到0.025，粒径均一性好；而对比例得到的面霜PDI指数均大于0.3，从附图9-11也可以看出面霜粒径分布范围宽。本发明脂质体面霜粒径小，平均粒径在100～300nm之间，实施例1得到的脂质体面霜粒径达到了122.52nm；而各对比例制得的普通面霜平均粒径均大于1000nm。
表1.粒径测定结果
| 样品名称 | 粒径(nm) | PDI |
| 实施例1 | 122.52 | 0.189 |
| 实施例2 | 181.90 | 0.070 |
| 实施例3 | 151.31 | 0.133 |
| 实施例4 | 201.2 | 0.228 |
| 实施例5 | 249.1 | 0.025 |
| 对比例1 | 3980 | 0.324 |
| 对比例2 | 1217.2 | 0.318 |
| 对比例3 | 1052.4 | 0.325 |
将实施例1制得的艾地苯醌活性物低共熔溶剂脂质体面霜分别放置在4℃、45℃、常温光照(RT)、-8℃条件下，分别在制备当天(0表示)、7天、14天、30天、60天、90天测定其平均粒径大小，形成粒径稳定性曲线图，参见附图13。可以看出，随着时间延长，本发明活性物低共熔溶剂脂质体面霜稳定性好。
5、外观稳定性
将各实施例制得的活性物低共熔溶剂脂质体面霜分别放置在4℃、常温光照(RT)、45℃、-8℃条件下储存，分别在制备当天(0表示)、30天拍照记录外观变化情况。参见附图12，可以看出，各实施例得到的活性物低共熔溶剂脂质体面霜在30天与刚制备得到的面霜在外观上几乎没有变化，可见其外观稳定性良好。
6、包封率稳定性
对实施例1制得的艾地苯醌活性物低共熔溶剂脂质体面霜分别放置在4℃、45℃、常温光照(RT)、-8℃条件下，分别在制备当天(0表示)、7天、14天、30天、60天、90天测定其包封率的变化。
包封率的测试采用超速离心法：将样品稀释10倍，在转速20000r/min下超速离心30分钟，取上层样品，用HPLC方法测定其中艾地苯醌的含量W测，再测定样品中艾地苯醌总含量W总，按照W测*10/W总*100％来计算包封率。
参见附图14，可以看出，在45℃高温条件下，艾地苯醌活性物低共熔溶剂脂质体面霜的包封率有所下降，其他温度条件下脂质体面霜的包封率都较稳定；总体看来，本发明的活性物低共熔溶剂脂质体面霜三个月包封率稳定性良好。
7、皮肤滞留量
将实施例1、2、3与对比例1、2、3制得的面霜分别放置在4℃、45℃、常温光照(RT)、-8℃条件下，在第90天测定各实施例与对比例中活性物含量。
检测结果如附图15、16、17所示，由结果可知：90天后，活性物低共熔溶剂脂质体面霜中活性物含量明显高于游离活性物面霜，超分子脂质体技术能够很好的保护活性物，减小环境对活性物的影响。
对实施例1、2、3与对比例1、2、3制得的面霜分别进行经皮滞留量检测：
实验前用植皮刀制备厚度为300±50μm的耳背猪皮模型，然后将其剪成接收池大小的圆形小块，放入生理盐水中备用。使用磷酸盐缓冲液(pH＝7.4)作为接收介质。实验时将皮肤模型固定于释放池和接收池之间，使角质层的一侧朝向释放池，真皮层一侧朝向接收池，并且保证皮肤与接收液紧密贴合，两者之间不得有气泡出现。随后向皮肤表面分别加入一定量的实施例1、2、3所得活性物低共熔溶剂脂质体面霜，接收池的温度维持在32±0.5℃，接收池内放入磁子，实验过程中保持其在转速300rpm。本实验对照组为对比例1、2、3所得游离活性物面霜，对照组和实验组均设置三个重复组。
在体外经皮行为8h以后，将皮肤取下，将表面残留溶液用纯水清洗干净，取透皮处的皮肤，剪碎，加入1.5ml提取液(实施例1-2和对比例1-2使用乙醇作为提取液，实施例3和对比例3使用纯水作为提取液)匀浆，超声处理1h以浸取皮肤中的活性物，匀浆液转移至离心管中，涡旋混匀，12000rpm/min离心10min，残渣用1ml对应的提取液重提一次，合并两次上清液，混匀取上清液，使用0.22μm滤膜过滤，按上述高效液相色谱检测方法进样分析，即为活性物低共熔溶剂脂质体面霜和游离活性物面霜的经皮滞留量。
测试结果如图18所示，由结果可知，各实施例制得的活性物低共熔溶剂脂质体面霜远大于各对比例制得的普通面霜的皮肤滞留量，实施例1中的艾地苯醌皮肤滞留量是对比例1的3.02倍；实施例2中的辅酶Q10皮肤滞留量是对比例2的2.91倍；实施例3中的烟酰胺皮肤滞留量是对比例3的2.44倍。说明本发明中的活性物低共熔溶剂脂质体面霜能有效促进功效成分的皮肤渗透。
8、人体皮肤斑贴试验
对实施例1和对比例1的样品分别进行斑贴试验，选取18—40岁志愿者共计33人，其中男性12名，女性21名。根据《化妆品安全技术规范》(2015版)进行实验并根据表2皮肤反应分级标准记录其结果。
表2.皮肤封闭型斑贴试验皮肤反应分级标准
分别对志愿者皮肤同时分别使用实施例1和对比例1的样品进行试验，经过观察，使用本发明实施例1样品的志愿者均为0级阴性反应，而使用对比例1样品的志愿者有2例1级反应，可以看出，本发明得到的活性物低共熔溶剂脂质体面霜对皮肤更友好，无明显过敏刺激现象。
9、肤感评价
随机选取18-40岁志愿者共计33人，其中男性14人、女性19人。通过对比试用实施例1(A)和对比例1(B)，对化妆品铺展性、吸收性、厚重感、滞粘感、油滑感五个维度进行评价。0-3分为较差，3-5为一般，5-7为良好，7-9为优秀，9-10非常优秀，综合得分结果如图19所示。
结果表明，实施例1得到的样品在铺展性、吸收性、厚重感、滞粘感、油滑感五个维度上均优于对比例1。说明本发明中的活性物低共熔溶剂脂质体面霜肤感显著优于传统面霜体系的肤感。
10、人体紧致功效评价
选择脸部皮肤松弛，有细纹或皱纹，眼角皱纹等级2-5级的中国健康男性/女性受试者33名，年龄范围为18～60岁。对受试者分组使用实施例1和对比例1的样品，连续使用样品28天后，用皮肤弹性测试仪Custometer dual MPA580测量，采用前后对照的方法，测量受试者皮肤弹性、皮肤紧致度，进行主观评估并拍摄全脸照片。实验结果通过统计学检验方法进行比较，判断其是否有统计学差异，分别得到皮肤弹性R2数据和皮肤紧致度F4数据。
参见附图20，由结果可知，受试者分别连续使用实施例1和对比例1样品28天，皮肤弹性R2与基础值相比均有有显著性提升，且实施例1的提升值高于对比例1。说明实施例1有显著提高皮肤弹性功效。
参见附图21，由此可知，受试者分别连续使用实施例1和对比例1样品28天，皮肤紧致度F4与基础值相比均有有显著性下降，且实施例1的下降率高于对比例1。说明实施例1有显著提高皮肤紧致度功效。
11、人体抗衰功效评价
选择脸部皮肤松弛，有细纹或皱纹，眼角皱纹等级2-5级的中国健康男性/女性受试者33名，年龄范围为18～60岁。对受试者分组使用实施例1和对比例1的样品，用皮肤快速光学成像系统PRIMOS测量皮肤粗糙度Sa，分别于第0天和第28天进行测试。采用前后对照的方法，测量受试者皮肤粗糙度，进行主观评估并拍摄全脸照片。实验结果通过统计学检验方法进行比较，判断其是否有统计学差异，得到皮肤粗糙度Sa数据。
参见附图22，由结果可知，受试者分别连续使用实施例1和对比例1样品28天，皮肤粗糙度Sa与基础值相比均有显著性下降，且实施例1的下降率高于对比例1。说明实施例1有显著改善皮肤粗糙度的功效。
上述本发明实施例序号仅仅为了描述，不代表实施例的优劣。
上面结合附图对本发明的实施例进行了描述，但是本发明并不局限于上述的具体实施方式，上述的具体实施方式仅仅是示意性的，而不是限制性的，本领域的普通技术人员在本发明的启示下，在不脱离本发明宗旨和权利要求所保护的范围情况下，还可做出很多形式，这些均属于本发明的保护之内。
Claims (10)
1.一种活性物低共熔溶剂脂质体面霜的制备方法，其特征在于，包括以下步骤：
1)活性物低共熔溶剂的制备：
精密称量活性物及其配体在40-100℃条件下加热溶解，搅拌混合均匀，冷却至室温，形成活性物低共熔溶剂，所述活性物低共熔溶剂包括油溶性活性物低共熔溶剂和水溶性活性物低共熔溶剂，分别制成油溶性活性物低共熔溶剂和水溶性活性物低共熔溶剂；
2)油相的制备：
将磷脂、胆甾醇、乳化剂在50-75℃水浴温度下溶解，磁力搅拌混匀后，加入步骤1)得到的油溶性活性物低共熔溶剂，搅拌混合制得油相；
3)水相的制备：
将稳定剂、保湿剂和纯水在50-75℃水浴温度下溶解，磁力搅拌混匀，加入步骤1)得到的水溶性活性物低共熔溶剂，搅拌均匀得到水相；
3)面霜的制备：
将得到的水相在剪切条件下缓慢加入油相，得到初乳；然后将初乳经高压均质处理，循环4～16次；冷却至35～60℃，加入pH调节剂搅拌均匀，继续冷却至室温得到活性物低共熔溶剂脂质体面霜。
2.如权利要求1所述一种活性物低共熔溶剂脂质体面霜的制备方法，其特征在于：所述活性物与配体的摩尔比为1:3-3:1。
3.如权利要求1所述一种活性物低共熔溶剂脂质体面霜的制备方法，其特征在于：剪切条件为剪切转速为5000-10000rpm；剪切温度为50-75℃；剪切时间为3-8min。
4.一种根据1-3中任一项所述权利要求制备方法得到的活性物低共熔溶剂脂质体面霜，其特征在于，包括以下质量百分比组分：
活性物低共熔溶剂：1.5-12.0％
磷脂：1.0-5.0％
乳化剂：1.0-3.0％
胆甾醇：0.1-0.5％
保湿剂：5.0-15.1％
稳定剂：0.2-0.8％
pH调节剂：0-0.5％
纯水：余量；
所述活性成分包括油溶性活性成分和/或水溶性活性成分。
5.如权利要求4所述一种活性物低共熔溶剂脂质体面霜，其特征在于：所述活性物低共熔溶剂选自以下至少一种：艾地苯醌薄荷脑、辅酶Q10薄荷脑、烟酰胺木糖醇、烟酰胺丙二醇、烟酰胺果糖、烟酰胺柠檬酸。
6.如权利要求4所述一种活性物低共熔溶剂脂质体面霜，其特征在于：所述磷脂选自大豆卵磷脂、氢化卵磷脂、溶血卵磷脂、蛋黄卵磷脂中的至少一种。
7.如权利要求4所述一种活性物低共熔溶剂脂质体面霜，其特征在于：所述乳化剂选自PEG-100硬脂酸酯、聚山梨醇酯-20、聚山梨醇酯-60、聚山梨醇酯-80、聚甘油-10-月桂酸酯、聚甘油-10-油酸酯、聚甘油-10-肉豆蔻酸酯、甘油硬脂酸酯、硬脂醇聚醚-21、鲸蜡硬脂基葡糖苷中的至少一种。
8.如权利要求4所述一种活性物低共熔溶剂脂质体面霜，其特征在于：所述保湿剂选自甘油、1,3-丙二醇、甘油葡糖苷、透明质酸钠、1，3-丁二醇、1,2-戊二醇、1,2-己二醇、乙基己基甘油、双丙甘醇、甘油葡糖苷中的至少一种。
9.如权利要求4所述一种活性物低共熔溶剂脂质体面霜，其特征在于：所述稳定剂选自EDTA-2Na、焦亚硫酸钠、生育酚、生育酚乙酸乙酯、卡波姆、聚丙烯酸酯交联聚合物-6中的至少一种。
10.如权利要求4所述一种活性物低共熔溶剂脂质体面霜，其特征在于：所述pH调节剂选自氢氧化钠，氢氧化钾，三乙醇胺，精氨酸，乳酸，柠檬酸中的至少一种。
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