CN111643376B - 一种纳米乳液组合物及其应用 - Google Patents
一种纳米乳液组合物及其应用 Download PDFInfo
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- CN111643376B CN111643376B CN202010540527.9A CN202010540527A CN111643376B CN 111643376 B CN111643376 B CN 111643376B CN 202010540527 A CN202010540527 A CN 202010540527A CN 111643376 B CN111643376 B CN 111643376B
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Abstract
本发明公开了一种纳米乳液组合物及其应用，包含如下组分：（A）乳化剂0.005‑2.5%；（B）高级醇0.01‑5%；（C）油脂0.02‑60%；（D）油溶性活性物0.01‑15%；（E）多元醇或多糖3‑30%；其中，所述组分（C）的含量≥组分（A）+组分（B）的含量之和。本发明通过选用低含量以及特定种类的乳化剂，与特定含量的高级醇、油脂、油溶性活性物以及多元醇或多糖进行复配，控制油脂含量≥乳化剂和乳化剂的复配重量之和，制备得到平均粒径≤200nm的纳米乳液组合物，该纳米乳液组合物可以明显降低乳化剂导致的刺激性；通过提升油溶性活性物的稳定性和透皮吸收效果，降低其刺激性作用，从而提高功效成分的利用率、功效和肌肤耐受性。
Description
技术领域
本发明涉及化妆品、食品或药品技术领域，特别涉及一种具有提升油溶性活性成分稳定性、功效和降低刺激性的纳米乳液组合物及其应用。
背景技术
各种添加功效性活性物的乳化组合物已被广泛应用于化妆品、食品或药品领域，但其乳化组合物多为膏霜状或者白浊的乳液传统的O/W乳化体系，其对功效性活性物的稳定性无提升效果，易出现变色、变味，严重的情况下甚至出现稳定性分层，如油溶性活性物如抗坏血酸四异棕榈酸酯、视黄醇棕榈酸酯和白藜芦醇等易发生高温变色分解，会影响产品外观和导致活性物含量降低；由于粒径较大，其无促进透皮吸收的效果；且由于部分功效性活性物具有一定的刺激性，在传统的O/W乳化体系中主要依靠降低功效活性物的用量或添加舒缓成分来降低其刺激性，如油溶性活性物如光甘草定由于刺激性较大，易导致皮肤刺激。这些特点限制了其在皮肤、头皮和毛发等用的化妆品、食品或药品的应用。
相对于传统O/W乳化体系，纳米乳液更适合用于功效性活性物的传输，由于其液滴尺寸小，表面积大，更利于内相功效性活性物的传输和透皮吸收，同时可以减少促渗剂的使用，消除潜在刺激。由于其具有缓释效果，故其可以降低功效性活性物的刺激性。
但由于目前纳米乳液主要采用D相乳化、凝集法或者为PIT乳化，其对配方的乳化剂选择，乳化剂用量、油脂种类和含量，以及工艺有一定的要求；乳化剂含量增加，从而可能导致配方刺激性增加；且由于稳定性原因，其油脂含量无法太高，从而导致无法充分溶解油溶性活性成分，其稳定性易出现问题；油脂种类受限，无法满足对油溶性活性成分的溶解。这些特点限制了其在皮肤、头皮和毛发等用的化妆品、食品或药品的应用。
发明内容
鉴于此，本发明的目的在于克服现有技术的不足，提供一种具有提升油溶性活性成分稳定性、功效和降低刺激性的纳米乳液组合物(平均粒径≤200nm)，该纳米乳液组合物具有低的粘度，从而具有便捷的使用感；且可使乳化剂的用量低至油脂用量的1/214，可以明显降低乳化剂导致的刺激性，从而提升提高肌肤的耐受性；针对本发明不受传统乳化体系配方需考虑不同油脂需不同HLB值乳化体系的特点，可不用在配方中不改变乳化剂种类及其用量的情况下，直接使用不同种类油脂，这个特性可以针对不同油溶性活性物使用不同的油脂来溶解，可大大拓宽配方对油溶性活性物的适应性，提供优异的配方稳定性，从而使配方开发简单化；可提升油溶性活性物的稳定性、提升油溶性活性物的透皮吸收效果和通过缓释作用可以降低油溶性活性物的刺激性作用，从而提高功效成分的利用率及产品功效。
本发明所述的一种纳米乳液组合物，按重量百分比计，包含如下组分：
其中，所述组分(C)的含量≥组分(A)+组分(B)两者的含量之和。
优选地，所述的纳米乳液组合物，按重量百分比计，包含如下组分：
其中，所述组分(C)的含量≥组分(A)+组分(B)两者的含量之和。
更优选地，所述的纳米乳液组合物，按重量百分比计，包含如下组分：
其中，所述组分(C)的含量≥组分(A)+组分(B)两者的含量之和。
其中，所述组分(A)选自烷基糖苷乳化剂、聚甘油乳化剂、氨基酸基gemini表面活性剂、卵磷脂及其改性乳化剂中的一种或几种。
本发明组分(A)的烷基糖苷乳化剂，其烷基基团，可以使用8-22碳的饱和和不饱和烷基基团。它们可以单独使用或者两种及两种以上前述物质混合使用。考虑到原料来源，特别优选月桂基、椰油基、肉豆蔻基、鲸蜡基和硬脂基中的一种或几种。
组分(A)烷基糖苷的葡萄糖聚合度没有特别限定，考虑到原料来源，特别优选糖苷平均聚合度为1-5。
本发明组分(A)的聚甘油乳化剂，其烷基基团，可以使用8-22碳的饱和和不饱和烷基基团。它们可以单独使用或者两种及两种以上前述物质混合使用。考虑到原料来源，特别优选月桂基、椰油基、肉豆蔻基、鲸蜡基和硬脂基中的一种或几种。
组分(A)的聚甘油乳化剂甘油聚合度考虑到原料来源，选择聚合度为6-10。
本发明组分(A)的氨基酸基gemini表面活性剂至少有两个疏水碳氢链、两个极性头基和一个联接基团，具体选自精氨酸基gemini表面活性剂、赖氨酸基gemini表面活性剂、胱氨酸基gemini表面活性剂和丝氨酸基gemini表面活性剂中的一种或几种；更优选为二(月桂酰胺谷氨酰胺)赖氨酸钠。
本发明组分(A)的卵磷脂及其改性乳化剂选自大豆卵磷脂、卵磷脂、羟基化卵磷脂、氢化卵磷脂、氢化溶血卵磷脂、溶血卵磷脂中的一种或几种。
其中，所述组分(A)+组分(B)两者的含量之和≥0.015％，在涂抹时水分的部分挥发，所以在该用量下可以得到膏霜般的使用感；组分(A)+组分(B)两者的含量之和优选≥0.1％；而当组分(A)+组分(B)两者的含量之和＜0.015％，不会引起凝胶化，就没有膏霜状的使用感。
优选地，所述组分(A)：组分(B)的复配重量比为≥1：0.3，优选为1：0.6。组分(A)：组分(B)＜1：0.3时，配方稳定性过程中粘度升高，无法达到本发明需求的低粘度要求。
本发明所述组分(B)的高级醇，可以包括辛醇、癸醇、月桂醇、肉豆蔻醇、硬脂醇、异硬脂醇、鲸蜡醇、油醇、亚油醇、山嵛醇、辛醇、十一醇、十三醇、十五醇、十七醇、十九醇、二十一醇中的一种或几种。它们可以单独使用或者两种及两种以上前述物质混合使用，特别优选硬脂醇和鲸蜡醇。
本发明所述组分(C)选自硅油、硅胶及其改性物、脂肪、油、蜡、疏水植物提取物、烯烃、类脂、酯、液态醇、维生素、防晒剂、香精油、磷酯中的一种或几种。所述硅油、硅胶及其改性物，如线性或环状聚二甲基硅氧烷，氨基、烷基、苯基硅油等；所述脂肪和油，包括天然的脂肪和油，如牛油果树果酯、霍霍巴籽油、鳄梨油、稻糠油、橄榄油、葡萄籽油，向日葵籽油、大豆油、杏仁油、椰子油，牛油、猪酯等；上述油经氢化所得的饱和油脂；以及合成的单、二或三酸甘油酯；其中，蜡，如羊毛酯等及其相应的衍生物；所述疏水植物提取物，具体指油溶性植物提取物；所述烯烃，如液体石蜡、矿酯、角鲨烯、角鲨烷和矿物油等；所述类脂，如胆固醇、蔗糖酯等；所述酯，如肉豆蔻酸异丙脂、棕榈酸异丙酯等；所述液态醇，如辛基十二醇等；所述香精油，如薄荷油、茉莉油、柠檬油，桉树油、茶树油、薰衣草精油等；它们可以单独使用或者两种及两种以上前述物质混合使用。
本发明所述组分(D)选自植物甾醇、白藜芦醇、神经酰胺、类神经酰胺类、辅酶Q10、曲酸二棕榈酸酯、富勒烯、光甘草定和油溶性维生素及其衍生物。所述油溶性维生素及其衍生物，如维生素A、D和E，以及维生素烷基酯，包括维生素C烷基酯。
本发明所述组分(E)选自甘油、山梨糖醇、丙二醇、丁二醇、戊二醇、异戊二醇、己二醇、葡萄糖、麦芽糖、麦芽糖醇、蔗糖、果糖、木糖醇、季戊四醇、淀粉降解糖中的一种或几种。
其中，所述纳米乳液组合物的平均粒径≤200nm，其使用工艺可以为高能乳化中的高压均质,微射流或超声波中的一种或几种。如果平均粒径超过200nm，则在低粘度下可能发生破乳或出现粘度增加现象。此处使用的平均粒径通过动态散射法测定，具体而言，使用马尔文mastersizer3000进行粒径测量。
本发明的纳米乳液组合物，具有提升油溶性活性成分稳定性、功效和降低刺激性，除上述主要成分以外，在不降低本发明效果的前提下，可以适当地含有普通化妆品、特殊化妆品、食品或药品等使用的多种合适的组分。更具体的讲，可以包括水、香精、紫外线吸收剂、润湿剂、生理活性成分、抗氧化剂、抗炎剂、抗菌剂、止汗药、螯合剂(如EDTA二钠)、增稠剂、中和剂、pH调节剂(如柠檬酸)等，并且可以根据特定的用途及形态来含有上述组分，其添加量为化妆品、食品或药品中的常规添加量。
本发明添加增稠剂如卡波姆后，在具有膏霜乳液的保湿效果的同时，可达到一抹化水的效果，在使用感上具有目前膏霜乳液配方无法达到的良好使用感。
本发明所述的纳米乳液组合物，具有提升油溶性活性成分稳定性、功效和降低刺激性，适合在作皮肤、头皮和毛发用的化妆品、食品或药品中的应用。
与现有技术相比，本发明的有益效果如下：
本发明通过选用低含量以及特定种类的乳化剂，与特定含量的乳化剂、油脂、油溶性活性物以及多元醇或多糖进行复配，控制油脂含量大于等于乳化剂和乳化剂的复配重量之和，制备得到平均粒径≤200nm的纳米乳液组合物，该纳米乳液组合物具有低的粘度，从而具有便捷的使用感；且可使乳化剂的用量低至油脂用量的1/214，可以明显降低乳化剂导致的刺激性，从而提升提高肌肤的耐受性；针对本发明不受传统乳化体系配方需考虑不同油脂需不同HLB值乳化体系的特点，可不用在配方中不改变乳化剂种类及其用量的情况下，直接使用不同种类油脂，这个特性可以针对不同油溶性活性物使用不同的油脂来溶解，可大大拓宽配方对油溶性活性物的适应性，提供优异的配方稳定性，从而使配方开发简单化；可提升油溶性活性物的稳定性、提升油溶性活性物的透皮吸收效果和通过缓释作用可以降低油溶性活性物的刺激性作用，从而提高功效成分的利用率及产品功效。
具体实施方式
下面通过具体实施方式来进一步说明本发明，以下实施例为本发明较佳的实施方式，但本发明的实施方式并不受下述实施例的限制。
本发明实施例所采用的原料均可通过市售得到。
各性能指标的测试方法如下：
纳米乳液组合物的稳定性测试方法：将样品分别放置在室温和50℃烘箱中，放置4周，测试样品外观、粒径、粘度和油溶性活性物稳定性。
纳米乳液组合物的外观的测试方法：室温和非阳光直射下目测观察。
纳米乳液组合物的平均粒径的测试方法：使用马尔文mastersizer3000进行粒径测量，使用D50作为粒径测量结果。
纳米乳液组合物的粘度的测试方法：
粘度范围0-50mPa·s：Brookfiled DV-C数显粘度计，61号转子，转速60rpm，料体温度：25℃，读数时间：启动后1分钟时读数。
粘度范围51-300mPa·s：Brookfiled DV-C数显粘度计，62号转子，转速60rpm，料体温度：25℃，读数时间：启动后1分钟时读数。
粘度范围301-1200mPa·s：Brookfiled DV-C数显粘度计，63号转子，转速60rpm，料体温度：25℃，读数时间：启动后1分钟时读数。
粘度范围1200-6000mPa·s：Brookfiled DV-C数显粘度计，64号转子，转速60rpm，料体温度：25℃，读数时间：启动后1分钟时读数。
油溶性活性物稳定性的测试方法：采用液相色谱法等方法对油溶性活性物含量进行标定，50℃1个月稳定性样品与初始样品测试结果对比，得出保留率。实施例1-33和对比例1-12：
按照配比将组分(A)乳化剂、组分(B)高级醇、组分(C)油脂和组分(D)油溶性活性物加热至规定温度并搅拌溶解均匀，即为油相预混；水和组分(E)多元醇或多糖加热至规定温度并搅拌溶解均匀，即为水相预混；将油相预混加入水相预混，保温搅拌均匀，进行高压均质至料体平均粒径≤200nm(粒径对比例均质至250nm和350nm左右)；冷却降温，加入剩余组分，调节pH至规定范围，即得纳米乳液组合物。制备得到纳米乳液组合物的外观、平均粒径、粘度、使用感和油溶性活性物稳定性等性能指标的具体数据如表1-6所示。
表1对比组分(A)乳化剂的含量及种类的实施例及对比例(重量百分比)
其中实施例2和3中50℃稳定性样品粘度增加至25.5-47.3，会影响喷雾泵头泵出效率，对泵头有更高的选择性，对比例1中50℃稳定性样品分层，对比例2中50℃稳定性样品颜色加深、粒径和粘度增加明显。说明乳化剂用量不同会导致样品稳定性过程中活性物氧化、粒径和粘度增加。
表2对比组分(B)高级醇的含量及种类的实施例及对比例(重量百分比)
其中实施例10、11和13中50℃稳定性样品粘度增加至37.9-89.4，会影响喷雾泵头泵出效率，对泵头有更高的选择性，对比例3、4和5中50℃稳定性样品颜色加深、粒径和粘度增加明显。说明高级醇用量不同会导致样品稳定性过程中活性物氧化、粒径和粘度增加。
表3对比组分(C)油脂的含量及种类的实施例及对比例(重量百分比)
其中实施例16和17中50℃稳定性样品粘度增加至29.7-41.6，会影响喷雾泵头泵出效率，对泵头有更高的选择性，对比例6中50℃稳定性样品颜色加深、粒径和粘度增加明显，对比例7中50℃稳定性破乳分层。说明油脂用量不同会导致样品稳定性过程中活性物氧化、粒径和粘度增加。
表4对比组分(D)油溶性活性物的含量及种类的实施例及对比例(重量百分比)
其中实施例25和26中50℃稳定性样品粘度增加至27.9-34.2，会影响喷雾泵头泵出效率，对泵头有更高的选择性，且颜色较深，影响其应用范围。对比例8中不添加活性物，无具体功效，无法满足消费者对功效的需求，只能作为基础化妆品使用；对比例9中50℃稳定性破乳分层，且搅拌均匀后检测油溶性活性物保留率低于实施例23-30。说明油溶性活性物用量不同会导致样品稳定性过程中活性物氧化和含量降低、粒径和粘度增加，甚至导致破乳分层。
表5对比组分(E)多元醇或多糖的含量及种类的实施例及对比例(重量百分比)
其中实施例32和33中50℃稳定性样品粘度增加至29.8-47.3，会影响喷雾泵头泵出效率，对泵头有更高的选择性；对比例10中50℃稳定性样品颜色加深、粒径和粘度增加明显；虽然对比例11样品中50℃样品稳定性良好，但由于多元醇过多，其初始粘度较高，影响喷雾泵出，且会导致肤感黏腻。说明多元醇或多糖用量不同会导致样品稳定性过程中活性物氧化、粒径和粘度增加，且多元醇或多糖用量增加会导致配方初始粘度较高黏腻肤感，故不推荐用量过多。
表6对比不同乳化粒径
对比例14中常温和50℃稳定性样品均分层，无法形成稳定配方，故需配方需使用高压均质,微射流或超声波，确保样品粒径≤200nm。对比例12(粒径超过200nm，为264nm)和对比例11(粒径超过200nm，为347nm)中常温粘度高于实施例38，50℃稳定性样品颜色加深、粒径和粘度增加明显，均导致不易通过喷雾泵出。说明粒径不同和不进行高能乳化使其粒径≤200nm会导致样品常温粘度较高，不易通过喷雾泵泵出；高温稳定性过程中活性物氧化、粒径和粘度增加，更加难以通过喷雾泵出。
应用配方例1：将实施例1所述纳米乳液组合物与其他化妆品、食品或药品原料混合，制备成啫喱，具体配方如表7所示：
表7
应用配方例2：将实施例17所述纳米乳液组合物与其他化妆品、食品或药品原料混合，制备成乳液，具体配方如表8所示：
表8
Claims (10)
1.一种纳米乳液组合物，其特征在于，按重量百分比计，包含如下组分：
（A）乳化剂 0.14-2.5%；
（B）高级醇 0.26-5%；
（C）油脂 15-60%；
（D）油溶性活性物 0.01-15%；
（E）多元醇或多糖 3-30%；
其中，所述组分（C）的含量≥组分（A）+组分（B）两者的含量之和；
所述纳米乳液组合物的平均粒径≤200nm；
所述组分（A）选自烷基糖苷乳化剂、聚甘油乳化剂、氨基酸基gemini表面活性剂、卵磷脂及其改性乳化剂中的一种或几种；
所述组分（A）：组分（B）的复配重量比为≥1：0.3。
2.根据权利要求1所述的纳米乳液组合物，其特征在于，按重量百分比计，包含如下组分：
（A）乳化剂 0.14-1.5%；
（B）高级醇 0.26-3%；
（C）油脂 15-40%；
（D）油溶性活性物 0.01-10%；
（E）多元醇或多糖 6-25%；
其中，所述组分（C）的含量≥组分（A）+组分（B）两者的含量之和。
3.根据权利要求2所述的纳米乳液组合物，其特征在于，按重量百分比计，包含如下组分：
（A）乳化剂 0.14-1.2%；
（B）高级醇 0.26-2%；
（C）油脂 15-20%；
（D）油溶性活性物 0.01-5%；
（E）多元醇或多糖 10-20%；
其中，所述组分（C）的含量≥组分（A）+组分（B）两者的含量之和。
4.根据权利要求1所述的纳米乳液组合物，其特征在于，所述烷基糖苷乳化剂的烷基选自月桂基、椰油基、肉豆蔻基、鲸蜡基、硬脂基中的一种或几种；所述聚甘油乳化剂选自甘油聚合度为6-10，烷基选自月桂基、椰油基、肉豆蔻基、鲸蜡基、硬脂基中的一种或几种；所述氨基酸基gemini表面活性剂至少有两个疏水碳氢链、两个极性头基和一个联接基团，选自：精氨酸基gemini表面活性剂、赖氨酸基gemini表面活性剂、胱氨酸基gemini表面活性剂和丝氨酸基gemini表面活性剂中的一种或几种；所述卵磷脂及其改性乳化剂选自大豆卵磷脂、卵磷脂、羟基化卵磷脂、氢化卵磷脂、氢化溶血卵磷脂、溶血卵磷脂中的一种或几种。
5.根据权利要求1-3任一项所述的纳米乳液组合物，其特征在于，所述组分（A）+组分（B）两者的含量之和≥0.015%。
6.根据权利要求5所述的纳米乳液组合物，其特征在于，所述组分（A）+组分（B）两者的含量之和≥0.1%。
7.根据权利要求1所述的纳米乳液组合物，其特征在于，所述组分（A）：组分（B）的复配重量比为≥1：0.6。
8.根据权利要求1-3任一项所述的纳米乳液组合物，其特征在于，所述组分高级醇（B）选自辛醇、癸醇、月桂醇、肉豆蔻醇、硬脂醇、异硬脂醇、鲸蜡醇、油醇、亚油醇、山嵛醇、十一醇、十三醇、十五醇、十七醇、十九醇、二十一醇中的一种或几种；所述组分（C）选自硅油、硅胶及其改性物、脂肪、蜡、疏水植物提取物、烯烃、类脂、液态醇、香精油中的一种或几种；所述组分（D）选自植物甾醇、白藜芦醇、神经酰胺、类神经酰胺类、辅酶Q10、曲酸二棕榈酸酯、富勒烯、光甘草定和油溶性维生素及其衍生物中的一种或几种；所述组分（E）选自甘油、山梨糖醇、丙二醇、丁二醇、戊二醇、异戊二醇、己二醇、葡萄糖、麦芽糖、麦芽糖醇、蔗糖、果糖、木糖醇、季戊四醇、淀粉降解糖中的一种或几种。
9.根据权利要求1-8任一项所述的纳米乳液组合物，其特征在于，所述纳米乳液组合物使用工艺可以为高能乳化中的高压均质,微射流或超声波中的一种或几种。
10.如权利要求1-9任一项所述的纳米乳液组合物在制备皮肤、头皮和毛发用的化妆品的应用，其特征在于：作为产品单独使用制备成喷雾、啫喱、乳液、膏、霜剂型。
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