WO2022048028A1 - 一种促进植物雌激素吸收的驻极体面膜及其制备方法 - Google Patents

一种促进植物雌激素吸收的驻极体面膜及其制备方法 Download PDF

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Publication number
WO2022048028A1
WO2022048028A1 PCT/CN2020/129896 CN2020129896W WO2022048028A1 WO 2022048028 A1 WO2022048028 A1 WO 2022048028A1 CN 2020129896 W CN2020129896 W CN 2020129896W WO 2022048028 A1 WO2022048028 A1 WO 2022048028A1
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Prior art keywords
electret
layer
facial mask
mask
drug
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PCT/CN2020/129896
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English (en)
French (fr)
Inventor
任培根
赵沛一
方鹏
曹江浪
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中国科学院深圳先进技术研究院
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Publication of WO2022048028A1 publication Critical patent/WO2022048028A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/4973—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with oxygen as the only hetero atom
    • A61K8/498—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with oxygen as the only hetero atom having 6-membered rings or their condensed derivatives, e.g. coumarin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61K8/0212—Face masks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/08—Anti-ageing preparations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M2037/0007—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents

Definitions

  • the invention belongs to the technical field of cosmetics, and in particular relates to an electret facial mask for promoting the absorption of phytoestrogens and a preparation method thereof.
  • Mask is a category of skin care products and a carrier of beauty care products. It is applied on the face for cosmetic functions such as moisturizing, whitening, anti-aging, balancing oil and so on. With the improvement of people's living standards, more and more people begin to pursue a refined life and pay more attention to skin care. Face masks have always been popular due to their portability, convenience in use, and good skin care effects. At present, my country's face mask market has a huge consumer group and great potential for development.
  • Soy isoflavones are biologically active substances extracted from plants and similar in structure to estrogens. Soy isoflavones, which mainly exist in legumes, can bind to estrogen receptors to function, so they are also called “phytoestrogens". Studies have found that soy isoflavones have multiple physiological functions, which can be summarized as: bidirectional regulation of estrogen levels in women, and improvement of women's menopause, osteoporosis and cardiovascular diseases. In addition, soy isoflavones also have anti-oxidative and anti-aging properties, improve skin quality, make women's skin smooth and elastic, and also have a relatively significant effect in beauty.
  • the traditional mask is applied on the surface of the skin, and the active ingredients enter the skin through natural penetration.
  • the absorption efficiency of the active ingredients is greatly reduced, and most of the active ingredients still stay on the skin surface.
  • chemical penetration enhancers are mainly composed of chemical organic compounds such as hydrocarbons, ketones and amides, which have certain irritation or other side effects on the skin, which may cause skin irritation. Adverse reactions occurred. Therefore, it is very necessary to develop a mask that effectively promotes the percutaneous penetration of active ingredients and has good biosafety.
  • Electret is a functional material that can store electrostatic charge for a long time and generate a stable electrostatic field in the surrounding space.
  • the external electric field usually requires special equipment, and the site and use environment are limited. The portability of the electret solves this problem very well.
  • the stable electrostatic field of electrets can change the arrangement of lipids in the stratum corneum, thereby facilitating the percutaneous penetration of active ingredients.
  • the electret electric field can also be used as a driving force for the transport of active ingredients, which promotes the transdermal transport of active ingredients.
  • the effect of electrets on skin tissue is currently mostly used in applications such as transdermal drug delivery.
  • electrets can not only provide driving force for drug molecules to penetrate the skin, but also adjust the microstructure of the skin. Therefore, based on this basis, the present invention proposes an electret facial mask for promoting the absorption of phytoestrogens and a preparation method thereof.
  • the object of the present invention is to address the above problems, propose a kind of electret facial mask for promoting the absorption of phytoestrogens and a preparation method thereof, in the case of not stimulating or damaging the skin, fully exert the permeation-promoting effect of the electret, and the electret It is used in beauty and skin care to enhance the skin's absorption of the drug molecules of the mask.
  • the electret can be made of materials with excellent biocompatibility. After polarization, it can generate a stable electrostatic field, which plays a role in opening the skin channel, changing the skin arrangement structure, promoting the transdermal transport and absorption of active ingredients, and enhancing the skin's ability to absorb the mask. Absorption of drug molecules.
  • Electret is a functional material that can store charges for a long time.
  • the electrostatic field on its surface can act on biological cells and tissues, and can promote the absorption of drug molecules by organisms.
  • the invention mainly utilizes electret to accelerate the absorption of the mask drug molecules by skin tissue.
  • the structure of the electret mask includes an electret layer and a mask drug layer. The purpose is to separate the electret and the mask drug, and combine the two when using.
  • the specific structure diagram is shown in Figure 1 below. .
  • Electrets are usually obtained by polarizing (charging) polymer materials, so electrets have good flexibility in addition to the effect of electrostatic fields.
  • the polymer used for the electret of the mask should have good biocompatibility in addition to its good charge storage capacity.
  • Common electrets include polypropylene (PP, Polypropylene), fluorinated ethylene propylene copolymer (FEP, Fluorinated Ethylene Propylene), polytetrafluoroethylene (PTFE, Polytetrafluoroethylene) and other electrets.
  • the polarization (charging) treatment of the polymer material used to prepare the electret can be carried out by a corona charging method, an electric breakdown charging method, a liquid contact charging method, or the like.
  • the corona charging method is a corona discharge formed by the local breakdown of the air caused by the non-uniform electric field at the tip, so that the generated charged particles are deposited on the polymer.
  • the use of corona charging method can make the polymer form a high-density electret with uniform distribution in the transverse direction.
  • the polarization equipment using the corona charging method has a structure including a corona needle, a metal grid, a metal base, a DC high voltage power supply for the corona needle, and a DC high voltage power supply for the metal grid.
  • the metal base is grounded (GND); the corona needle is on the metal base and maintains a certain distance from the metal base (the specific distance data is determined according to the property parameters of the specific polymer), and at the same time is connected with the corona needle DC high voltage power supply, so that the It can generate corona discharge; the metal grid is located between the corona needle and the metal base, where a small distance (usually 1 to 2cm) is maintained between the metal grid and the metal base, and the metal grid generally uses 5 to 300. Purpose metal mesh, the size of the metal mesh is larger than that of the metal base, and the metal mesh is connected to the DC power supply of the metal mesh. The purpose of using a metal grid in this polarization device is to improve the uniformity of the distribution of charged particles injected into the polymer.
  • FIG. 4 is a schematic diagram of the structure of the polarization equipment based on the corona charging method.
  • the specific polarization steps of the corona polarization (charging) method are: place the polymer on the metal base, first turn on the DC voltage source of the metal grid, adjust the voltage to a suitable voltage, and then turn on the DC high voltage power supply of the corona needle, and adjust it to At the appropriate voltage, the polymer material is already in the process of polarization charging; after about 2 minutes, turn off the corona needle DC high voltage power supply and the metal grid DC high voltage power supply respectively, and the polarization charging of the sample is completed.
  • the voltage of the metal grid needs to be lower than the voltage of the corona needle.
  • the metal grid in the polarization equipment is not an essential part, and it is generally judged according to the polarization characteristics of the polymer whether to use the metal grid in the polarization process. .
  • polarizing polymer films of smaller size a single corona needle can be used for polarization; while when polarizing polymer films of larger size, multiple corona needle arrays in the same plane can be used.
  • the electrical breakdown charging method refers to the charging of the dielectric through the large-area electrode effect of the polymer film and the air gap between the electrodes.
  • an electrode needs to be plated on one side of the film.
  • polarizing first place the polymer film coated with electrodes on one side on the metal base, the side of the polymer film without electrodes is facing up, and contact with a piece of soda glass with a thickness of 1 to 3 mm, and then put it on the metal base. A piece of metal electrode is pressed; then a DC voltage of 1 to 30kV is applied between the metal base and the metal electrode, so that the air gap is electrically broken down at room temperature or high temperature for several minutes. After that, disconnect the power supply, keep the electrode plated with the polymer film and the metal electrode in a short-circuit state, and quickly remove the polarized polymer film (electret) from the metal base.
  • Liquid contact charging is a charging method that transfers space charges from a conductive liquid to the surface of a polymer film to be polarized.
  • polarization using this method, one side of the polymer film also needs to be coated with electrodes.
  • When polarizing place an electrode covered with a damp cotton fabric on the side of the polymer film that is not plated with electrodes, and apply a DC voltage of 100 to 1000 V between the upper and lower electrodes; then, under the condition of maintaining the electric field, lift the electrode , and the liquid is evaporated, and the polymer film is successfully polarized at this time.
  • Commonly used liquids for this method include ethanol, acetone, deionized water, 0.1 mol/L hydrochloric acid or sodium hydroxide solution. It should be noted that, to use this method for polarization (charging) treatment, the surface of the polymer film must be free of dust contamination to prevent droplets from depositing on the film surface.
  • the electret obtained by polarization (charging) treatment will have a period of rapid charge decay. During the period of rapid charge decay, the charge density stored on the electret surface will decrease sharply. After a period of rapid charge decay, the charge decay of the electret becomes smaller and smaller, and finally stabilizes within a certain value range.
  • the electret in the present invention adopts an electret after a period of rapid charge decay.
  • the electret mask will not affect the use and operation of the mask due to the small thickness of the electret during the application process; the other is to facilitate the storage and transportation of the electret.
  • the prepared electret after the rapid charge decay period needs to be placed in a dry environment.
  • a thinner layer with a relatively thin film can be added on the polarization surface of the electret (the side where the electric charge is stored in the electret).
  • An electret facial mask for promoting the absorption of phytoestrogens comprises an electret layer and a facial mask drug layer, the electret is obtained by polarizing a polymer material, and the facial mask drug layer is a facial mask
  • the sheet layer formed by the medicine or the base layer absorbing the mask medicine, the electret layer and the mask medicine layer are separately packaged, the electret layer is an electret after a period of rapid charge decay, and the thickness of the electret layer is below 200 ⁇ m , and the specific thickness is determined according to the electrical storage properties of the polymer material.
  • a support layer is bonded on the non-polarized surface of the electret, and the purpose of bonding the support layer is to ensure that the mask does not deform; preferably, the support layer is selected from polymer films, and the polymer
  • the material includes polypropylene, fluorinated ethylene propylene copolymer, and polytetrafluoroethylene; it should be noted that when the thickness of the electret is less than 50 ⁇ m, the support layer is only bonded to the non-polarized surface of the electret. If the thickness is greater than 50 ⁇ m, the adhesive support layer can be omitted, because the thicker film is not easily deformed.
  • an isolation layer is bonded on the polarization surface of the electret; preferably, the isolation layer is selected from polymer films.
  • the isolation layer is not necessary. If the isolation layer is used, a polymer film with better electric field penetration and biocompatibility is generally used, such as FEP or PCTFE with a thickness of 30 ⁇ m.
  • the base layer includes non-woven fabrics, biological fibers, all-cotton fabrics, and silk fabrics.
  • the polarization treatment of the polymer material includes corona charging method, electric breakdown charging method, and liquid contact charging method.
  • the mask medicine by weight percentage, includes soybean isoflavone 0.01-5 wt%, moisturizing agent 0.1-5 wt%, pH adjuster 0.001-5 wt% wt%, emulsifier 5-10 wt%, water 70-90 wt%.
  • Soy isoflavones include one or more of Daidzingroups, Genistingroups, and Glycitingroups, each of which includes free, glucoside, and acetyl glucoside. , 4 forms of malonyl glucoside type.
  • the source of soy isoflavones can be plant extracts, such as from soybean, or commercial products can be purchased.
  • the moisturizing agent includes at least one of glycerin, aloe vera gel, and sodium hyaluronate;
  • the pH adjuster includes at least one of lactic acid and triethanolamine;
  • the emulsifier includes at least PEG-40 hydrogenated castor One of sesame oil, PEG-60 hydrogenated castor oil, PPG-26-butanol polyether-26 bis-PEG-18 methyl ether dimethyl silane.
  • the preparation method of the above-mentioned electret facial mask is obtained by separately packaging the electret layer and the facial mask drug layer after preparation;
  • the preparation of the mask drug layer comprises the following steps:
  • step (3) Add the product of step (1) to step (2), keep the temperature at 70-80 °C, and stir evenly;
  • the sheet layer formed by absorbing the paste mask medicine of step (4) through the base layer is the mask medicine layer.
  • the prepared cream mask drug can be directly applied to the skin; or a sheet formed by impregnating the mask drug with a small thickness, meshed non-woven fabric, biofiber, cotton cloth, silk cloth, etc., is used as the mask drug layer, and then Then stick it on the skin.
  • the thickness of the mask drug layer should be as small as possible.
  • Non-woven fabrics, bio-fibers, cotton fabrics, silk fabrics, etc. should be as small as possible.
  • the preparation of the electret layer includes the following steps:
  • the electret adopts the electret after the period of rapid charge decay
  • the stirring is performed for 10-20 min, and the stirring rate is 30-60 rpm. It should be noted that if the electret has a good charge storage capacity or does not require a long mask to use At times, the electret may not be encapsulated, or if the thickness of the electret layer is greater than 50 ⁇ m, the adhesive support layer may not be required.
  • the electret layer and the mask drug layer are separately packaged.
  • the mask drug layer is first placed on the skin, and then the electret layer is placed on the mask. On the drug layer, the electret layer sticks to the mask drug layer for more than 30 minutes.
  • the present invention combines the electret and phytoestrogen, proposes and designs an electret facial mask including an electret layer, a facial mask drug layer and other structures and a preparation method thereof, so as to promote the skin's ability to respond to the phytoestrogen and other facial mask drug molecules Absorption.
  • the electret layer and the mask drug layer are separately packaged.
  • the electret mask first place the mask drug layer on the skin, and then place the electret layer on the mask drug layer. Attention should be paid to the use of: First, the mask drug layer should be as thin as possible, and second, the electret layer should be applied to the mask drug layer for more than 30 minutes as much as possible.
  • the mask drug layer is formed by applying an ointment-like mask drug on the skin, the thickness of the applied ointment should be as small as possible.
  • Figure 3 shows the use process of the electret mask.
  • the electret is a physical permeation-promoting source, the preparation method is simple, and it is not limited by large-scale equipment sites and environments, and is easy to use.
  • the electrostatic field and micro-current promote the effective skin absorption of skin care ingredients, and will not cause skin sensitivity problems. , good biocompatibility, friendly to the environment;
  • Soy isoflavones as the main component of skin care, are natural plant sources, showing supplementary effects of antioxidants and estrogens, which can effectively improve skin conditions and regulate metabolism in the body;
  • electrets can not only provide driving force for the penetration of mask drug molecules, but also adjust the skin microstructure and enhance the absorption of mask drug molecules by skin tissue. Compared with masks with chemical penetration enhancers, electret masks have advantages in terms of safety.
  • the facial mask prepared by the present invention has the advantages of simple preparation method, low cost, no need for large-scale equipment to be applied anytime and anywhere, and no irritation to the skin.
  • Figure 1 is a schematic structural diagram of an electret mask, wherein (a) is a schematic diagram of the electret mask before use, and (b) is a schematic diagram of the electret mask in use;
  • Fig. 2 is the preparation flow chart of electret facial mask
  • Fig. 3 is the use flow chart of electret facial mask
  • Figure 4 is a schematic diagram of the structure of the polarization equipment based on the corona charging method
  • FIG. 5 is a graph showing the change of surface potential of FEP electret through cell culture medium.
  • the electret mask for promoting the absorption of phytoestrogens includes an electret layer and a mask drug layer, wherein the electret layer is prepared from a polymer material through polarization (charging) treatment, and the mask drug layer contains a skin care layer.
  • Phytoestrogen soy isoflavones Phytoestrogen soy isoflavones.
  • an electret layer is added on the drug layer of the mask, and the electrostatic field and microcurrent generated by the electret can promote the penetration of the drug into the skin.
  • the polarization (charging) treatment of the FEP is carried out by the corona charging method.
  • the schematic diagram of the polarization equipment is shown in Figure 4.
  • the size of the polarized FEP film is greater than about 10 cm * 10 cm, it is recommended to use a corona pin array with multiple corona pin arrays in the same plane for polarization, or use a knife-edge, string-type linear corona
  • the electrodes are polarized.
  • the specific preparation steps and condition parameters are as follows:
  • the metal grid can be removed;
  • the non-polarized surface of the FEP electret needs to be bonded to a film such as polychlorotrifluoroethylene (PCTFE) or polyethylene naphthalate (PEN) with a thickness greater than about 100 ⁇ m before being used in the mask drug layer .
  • PCTFE polychlorotrifluoroethylene
  • PEN polyethylene naphthalate
  • the graph of the surface potential value measured through the cell culture medium on the polarized surface of the FEP electret shows that the surface potential value on the cell culture medium does not drop to 0 until about 10 h. Therefore, the FEP electret applied in the present invention can act on the mask drug layer for a long time as a physical permeation-promoting source to enhance the absorption of the mask drug molecules by the skin tissue.
  • composition of the mask drug layer 1 wt% genistein, 1 wt% glycerin, 0.5 wt% pH adjuster, 10 wt% emulsifier, and the rest is deionized water; there is no special pH adjuster.
  • the emulsifier is the combination of PEG-40 hydrogenated castor oil, PEG-60 hydrogenated castor oil, PPG-26-butanol-26 bis-PEG-18 methyl ether dimethyl silane thing.
  • step 3 Add the product of step 1 into step 2, keep at 75°C, and stir at a rate of 50 rpm for 20 min;
  • Step 3 Cool the product to 40°C, stir evenly, add a pH regulator, adjust the pH to 7.4, and stir evenly;
  • step 4 Immerse the non-woven fabric of the base layer of the mask in step 4 Product 30-60 min, take out the mask drug layer.

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Abstract

一种促进植物雌激素吸收的驻极体面膜及其制备方法，属于化妆品技术领域。驻极体面膜包括驻极体层和面膜药物层，驻极体为聚合物材料极化处理得到，面膜药物层为面膜药物或者基层吸透面膜药物形成的片状层，驻极体层和面膜药物层分别独立包装，驻极体采用电荷急剧衰减期后的驻极体。驻极体面膜使用前，驻极体层和面膜药物层分别独立包装，驻极体面膜使用时，先将面膜药物层置于皮肤上，然后再将驻极体层置于面膜药物层上，驻极体层贴敷在面膜药物层上的时间大于30分钟。驻极体作为物理促渗源，不仅可以为面膜药物分子渗透供驱动力，还可调节皮肤微观结构，增强皮肤组织对面膜药物分子的吸收。

Description

一种促进植物雌激素吸收的驻极体面膜及其制备方法 技术领域
本发明属于化妆品技术领域，具体涉及一种促进植物雌激素吸收的驻极体面膜及其制备方法。
 背景技术
面膜，是护肤品中的一个类别，是美容保养品的一种载体，敷在脸上用于美容功能例如补水保湿、美白、抗衰老、平衡油脂等等。随着人们生活水平日益提高，有更多的人开始追求精致生活，对皮肤保养也更加重视。面膜因便携、使用方便、护肤效果较好等特点而一直备受欢迎，目前我国面膜市场的消费群体庞大，发展潜力巨大。
植物雌激素是一种从植物中提取、与雌激素结构相似的类生物活性物质。主要存在于豆科植物中的大豆异黄酮，能与雌激素受体结合发挥功能，因此也称其为“植物雌激素”。研究发现，大豆异黄酮具有多重生理功能，具体归纳为：双向调节女性体内雌激素水平，改善女性更年期、骨质疏松和心血管疾病等问题。此外，大豆异黄酮还具有抗氧化抗衰老，改善肤质，使女性皮肤光润富有弹性，在美容方面也具有比较显著的效果。
传统的面膜是通过敷在皮肤表面，通过自然渗透使有效成分进入皮肤内部，但由于角质层的天然屏障作用，使有效成分的吸收效率大幅降低，大部分的有效成分仍然停留在皮肤表面，难以渗透至皮下，被人体吸收利用。虽然面膜中应用化学促渗剂能提升有效成分的渗透量，但化学促渗剂主要由烃、酮和酰胺等化学有机物组成，对皮肤都有一定的刺激性或其他的副作用，可能会导致皮肤出现不良反应。所以目前开发一种有效促进有效成分经皮渗透并且生物安全性好的面膜是十分必要的。
驻极体是一种功能材料，能长期储存静电荷，并在周围空间产生稳定的静电场。外加电场通常需要专用的设备，场地和使用环境受限，驻极体的便携性很好的解决了这个问题。研究表明，驻极体的稳定静电场能改变角质层类脂的排列结构，从而有利于有效成分经皮渗透。此外，驻极体电场还可以作为有效成分的转运推动力，促进有效成分经皮转运。驻极体对皮肤组织的作用，目前多用在透皮给药等应用中。驻极体作为一种能储存电荷的功能材料，其静电场效应不仅可以为药物分子渗透皮肤提供驱动力，还可调节皮肤微观结构。因此，基于此基础，本发明提出一种促进植物雌激素吸收的驻极体面膜及其制备方法。
 技术问题
本发明的目的在于针对上述问题，提出一种促进植物雌激素吸收的驻极体面膜及其制备方法，在不刺激或损伤皮肤的情况下，充分发挥驻极体的促渗作用，将驻极体对药物分子的促渗作用以及对皮肤的调节作用应用于美容护肤之中，增强皮肤对面膜药物分子的吸收。驻极体可以选用生物相容性优良的材料，极化后能产生稳定的静电场，在打开皮肤通道，改变皮肤排列结构，推动有效成分经皮转运和吸收等方面发挥作用，增强皮肤对面膜药物分子的吸收。
驻极体是一种能长期储存电荷的功能材料，其表面所具有的静电场可作用于生物细胞、组织，以及可促进生物体对药物分子的吸收。本发明主要利用驻极体来加快皮肤组织对面膜药物分子的吸收。实验发现，驻极体的极化面（储存有电荷的一面）若长时间与溶液或导电物质接触，其所储存的电荷会大量流失掉，从而使驻极体的静电场作用快速失效。基于此，驻极体面膜的结构包括驻极体层和面膜药物层，其目的是将驻极体和面膜药物分开放置，使用的时候才将两者相结合，具体结构示意图如下图1所示。
驻极体的制备、封装方式：
驻极体通常将聚合物材料经极化（充电）处理后得到，因此驻极体除了具有静电场作用外，还具有良好柔性的特性。用于面膜的驻极体所用的聚合物，除其应具有较好的电荷储存能力外，还应具有较好的生物相容性。常见的驻极体有聚丙烯（PP，Polypropylene）、氟化乙烯丙烯共聚物（FEP，Fluorinated Ethylene Propylene）、聚四氟乙烯（PTFE，Polytetrafluoroethylene）等驻极体。用于制备驻极体的聚合物材料的极化（充电）处理可采用电晕充电法、电击穿充电法、液体接触充电法等方法。
其中，电晕充电法是尖端处的非均匀电场引起的空气局部击穿形成的电晕放电，使之产生的带电粒子沉积在聚合物上。利用电晕充电法可使得聚合物形成横向均匀分布的高密度驻极体。采用电晕充电法的极化设备，其结构包括电晕针、金属栅网、金属底座、电晕针直流高压电源、金属栅网直流高压电源。其中，金属底座接地（GND）；电晕针在金属底座之上并与金属底座保持一定间距（具体间距数据根据具体聚合物的性质参数确定），同时与电晕针直流高压电源相连接，使之能够产生电晕放电；金属栅网位于电晕针和金属底座之间，其中金属栅网与金属底座之间保持较小的间距（一般是1到2cm），金属栅网一般采用5到300目的金属网，金属栅网的尺寸大于金属底座即可，并且金属栅网与金属栅网直流电源相连接。该极化设备中使用金属栅网的目的是提高带电粒子注入聚合物的分布均匀性。附图4为基于电晕充电法的极化设备结构示意图。
电晕极化（充电）法具体的极化步骤是：将聚合物放置在金属底座上，先打开金属栅网直流电压源，调到合适电压，随后打开打开电晕针直流高压电源，调到合适电压，此时聚合物材料已在极化充电中；大约过了2min后，分别关掉电晕针直流高压电源、金属栅网直流高压电源，样品的极化充电完成。另外，极化过程中，金属栅网的电压需小于电晕针的电压。在通过电晕极化（充电）法进行极化处理的实际运用中，极化设备中金属栅网不是必须部件，一般是根据聚合物的极化特性判断是否在极化过程中使用金属栅网。极化处理较小尺寸的聚合物薄膜时，可使用单个电晕针进行极化；而极化处理较大尺寸的聚合物薄膜时，可使用同一平面内多个电晕针阵列排布的电晕针阵列进行极化，或使用刀口型、弦丝型线状的电晕电极进行极化。
电击穿充电法是指通过聚合物薄膜和电极间气隙的大面积电极效应实现对电介质的充电。聚合物薄膜在使用电击穿充电法进行极化（充电）处理时，需要在薄膜的一面镀上电极。极化时，首先将单面镀电极的聚合物薄膜放置在金属底座上，聚合物薄膜没镀电极的那一面朝上，并和一块厚度为1到3mm的钠玻璃相接触，其上再压一块金属电极；然后将1到30kV的直流电压施加于金属底座和金属电极之间，使气隙在室温或高温条件下电击穿几分钟。之后，断开电源，保持聚合物薄膜所镀的电极和金属电极处于短路状态，快速在金属底座上取走极化处理后的聚合物薄膜（驻极体）。
液体接触充电法是一种把空间电荷从导电液体转移到待极化的聚合物薄膜表面的充电方法。使用该方法进行极化（充电）前，同样需要把聚合物薄膜的一面镀上电极。极化时，将聚合物薄膜没镀电极的那面放置一个覆盖潮湿棉织物的电极，并在上下电极间施加量值为100到1000V的直流电压；然后在维持电场的条件下，将电极抬起，并使液体蒸发，此时聚合物薄膜则极化成功。该方法常用的液体包括乙醇、丙酮、去离子水、0.1mol/L的盐酸或氢氧化钠溶液。需要注意的是，使用该方法进行极化（充电）处理，聚合物薄膜表面必须无灰尘污染，以免液滴沉积在薄膜表面。
极化（充电）处理得到的驻极体，会有一个电荷急剧衰减期。电荷急剧衰减期内，驻极体表面所储存的电荷密度会急剧减小。电荷急剧衰减期后，驻极体的电荷衰减变得越来越小，最后稳定在某值的范围内。本发明中的驻极体采用电荷急剧衰减期后的驻极体。
不过，有些电荷储存稳定性较好的驻极体（如厚度为50μm的FEP驻极体），由于其厚度较小，使得驻极体在实际应用中会出现折叠、变形等状况，从而会影响到驻极体对外作用的稳定性。因此，对于厚度厚度小于50μm聚合物薄膜的驻极体，其非极化面（驻极体中不储存电荷的那一面）可粘一层厚度为30μm聚合物薄膜，比如的FEP、PCTFE、PEN等作为支撑结构。这样做，一是驻极体面膜在应用过程中不因驻极体厚度较小而影响面膜的使用与操作；二是方便驻极体的储存与运输。另外，需要注意的是，制备好的、且在电荷急速衰减期后的驻极体需要放置在干燥的环境中。另外，为了使得驻极体的静电场对面膜药物层或皮肤作用时间更长，可在驻极体的极化面（驻极体中储存电荷的那一面）上加一层较薄的具有较好生物相容性，以及较好的电场穿透性的聚合物薄膜的聚合物薄膜，比如厚度为30μm的FEP作为隔离层，其中该聚合物需具有较好的电场穿透性和生物相容性。
 技术解决方案
一种促进植物雌激素吸收的驻极体面膜，所述驻极体面膜包括驻极体层和面膜药物层，所述驻极体为聚合物材料极化处理得到，所述面膜药物层为面膜药物或者基层吸透面膜药物形成的片状层，所述驻极体层和面膜药物层分别独立包装，驻极体层采用电荷急剧衰减期后的驻极体，驻极体层厚度为200μm以下，具体厚度根据聚合物材料的储电性能决定。
进一步的，所述驻极体的非极化面上粘接有支撑层，粘结支撑层的目的就是为了保证面膜不发生形变；优选的，所述支撑层选自聚合物薄膜，所述聚合物材料包括聚丙烯、氟化乙烯丙烯共聚物、聚四氟乙烯；需要说明的是，当驻极体厚度小于50μm，才在驻极体的非极化面粘接支撑层，若驻极体厚度大于50μm，可不用粘接支撑层，因为较厚的薄膜不容易发生形变。
进一步的，所述驻极体的极化面上粘结有隔离层；优选的，所述隔离层选自聚合物薄膜。隔离层不是必须的，隔离层使用的话，一般是采用较好电场穿透性和生物相容性的聚合物薄膜，比如厚度为30μm的FEP或PCTFE。
进一步的，所述基层包括无纺布、生物纤维、全棉布、蚕丝布。
进一步的，所述聚合物材料的极化处理包括电晕充电法、电击穿充电法、液体接触充电法。
进一步的，所述面膜药物，按重量份百分比计，包括大豆异黄酮0.01-5 wt%、保湿剂0.1-5 wt%、pH调节剂0.001-5 wt%、乳化剂5-10 wt%、水70-90 wt%。
大豆异黄酮包括黄豆苷类(Daidzingroups)、染料木苷类(Genistingroups)、黄豆黄素苷类(Glycitingroups)中的一种或多种，每类包括游离型、葡萄糖苷型、乙酰基葡萄糖苷型、丙二酰基葡萄糖苷型4种存在形式。大豆异黄酮来源可以为植物提取物，比如从大豆中提取，也可购买商品化的产品。
进一步的，所述保湿剂至少包括甘油、芦荟胶、透明质酸钠中的一种；所述pH调节剂至少包括乳酸和三乙醇胺中的一种；所述乳化剂至少包括PEG-40氢化蓖麻油、PEG-60氢化蓖麻油、PPG-26-丁醇聚醚-26双-PEG-18甲基醚二甲基硅烷中的一种。
上述驻极体面膜的制备方法，将驻极体层和面膜药物层制备后分别独立包装即得；
所述面膜药物层的制备，包括以下步骤：
（1）将大豆异黄酮和乳化剂加热至70-80 ℃，保温；
（2）将保湿剂加入水中，加热至70-80 ℃，保温；
（3）将步骤（1）产物加入步骤（2）中，保持温度在70-80 ℃，搅拌均匀；
（4）当温度冷却至40-50 ℃时，加入pH调节剂，调节pH值在4.0-8.0之间，搅拌均匀，获得膏状面膜药物即为面膜药物层；
或将基层吸透步骤（4）的膏状面膜药物形成的片状层即为面膜药物层。
制备好的膏状面膜药物可直接涂抹于皮肤上；或者将厚度较小、带有网孔的无纺布、生物纤维、全棉布、蚕丝布等浸透面膜药物所形成薄片作为面膜药物层，然后再贴敷在皮肤上。
需要注意的是，当采用带有网孔的无纺布、生物纤维、全棉布、蚕丝布等吸透面膜药物后形成的薄片状面膜药物层，为使得面膜药物层厚度尽量小，需使用厚度尽量小的无纺布、生物纤维、全棉布、蚕丝布等。
所述驻极体层的制备，包括以下步骤：
①聚合物材料极化处理；
②电荷急速衰减期，所述驻极体采用电荷急剧衰减期后的驻极体；
进一步的，步骤（3）和步骤（4）中，搅拌10-20 min，搅拌速率为30-60 rpm，需要说明的是，如果驻极体的电荷储存能力不错或者不需要太长的面膜使用时间，驻极体可以不用进行封装，或者如果驻极体层的厚度大于50μm，可以不用粘合支撑层。
更进一步的，驻极体面膜使用前，驻极体层和面膜药物层分别独立包装，驻极体面膜使用时，先将面膜药物层置于皮肤上，然后再将驻极体层置于面膜药物层上，驻极体层贴敷在面膜药物层上的时间大于30分钟。
本发明将驻极体与植物雌激素相结合，提出并设计一种包括驻极体层、面膜药物层等结构的驻极体面膜及其制备方法，以促进皮肤对植物雌激素等面膜药物分子的吸收。
驻极体面膜使用前，其驻极体层和面膜药物层是分别独立包装。驻极体面膜使用时，先将面膜药物层置于皮肤上，然后再将驻极体层置于面膜药物层上。使用是需注意：一是面膜药物层尽量要薄，二是驻极体层贴敷在面膜药物层上的时间尽量在30分钟以上。当通过在皮肤上涂抹药膏状的面膜药物形成面膜药物层时，涂抹药膏的厚度要尽量小。图3为驻极体面膜的使用流程。
 有益效果
（1）驻极体为物理促渗源，制备方法简单，不受大型设备场地和环境的限制，使用方便，静电场和微电流促进护肤有效成分经皮吸收效果明显，不会引起皮肤敏感问题，生物相容性好，对环境友好；
（2）大豆异黄酮作为护肤的主要成分，为天然植物来源，表现出了抗氧化和类雌激素的补充作用，可有效改善皮肤状况，调节体内代谢；
（3）驻极体作为物理促渗源，不仅可以为面膜药物分子渗透供驱动力，还可调节皮肤微观结构，增强皮肤组织对面膜药物分子的吸收。与添加化学促渗剂的面膜相比，驻极体面膜在安全性上存在优势。此外，本发明制备的面膜具有制备方法简单，成本低，无需大型设备随时随地施用，对皮肤无刺激等优点。
 附图说明
图1为驻极体面膜的结构示意图，其中，（a）图为驻极体面膜使用前的示意图，（b）图为驻极体面膜使用时的示意图；
图2为驻极体面膜的制备流程图；
图3为驻极体面膜的使用流程图；
图4 为基于电晕充电法的极化设备结构示意图；
图5为FEP驻极体透过细胞培养基的表面电位变化曲线图。
 本发明的实施方式
下面结合实施例，对本发明作进一步地详细说明，但本发明的实施方式不限于此。
实施例1
参照图2，促进植物雌激素吸收的驻极体面膜，包括驻极体层和面膜药物层，其中驻极体层由聚合物材料经极化（充电）处理制备成的，面膜药物层含有护肤植物雌激素大豆异黄酮。本发明在面膜药物层上，增加了驻极体层，可通过驻极体产生的静电场和微电流，促进药物向皮肤内渗透。
1.驻极体层
（1）驻极体的制备：
使用30μm厚度的氟化乙烯丙烯共聚物（FEP）薄膜作为驻极体的材料，采用电晕充电法进行FEP的极化（充电）处理，极化设备示意图如图4所示。当所极化的FEP薄膜尺寸约大于10 cm * 10 cm，建议采用同一平面内多个电晕针阵列排布的电晕针阵列进行极化，或使用刀口型、弦丝型线状的电晕电极进行极化。具体的制备步骤及条件参数如下：
①将一定尺寸的FEP薄膜放置在电晕极化设备的金属底座上，需要注意的是，电晕针在金属底座上的垂直映射区域应在FEP薄膜上；
②打开金属栅网直流电源，输出电压调到0到-5kV，另外当电晕针与金属栅网金属底座的间距约大于5cm，可撤去金属栅网；
③打开电晕针直流电源，将输出电压调到-25 kV；
④计时1到2min，到时间后分别关掉电晕针直流电源、金属栅网直流电源。
（2）驻极体的封装：
由于所使用的氟化乙烯丙烯共聚物（FEP）薄膜厚度较小，为30 μm，使得该驻极体在实际应用中会出现折叠、变形等状况，从而影响到驻极体对外作用的稳定性。因此，在用于面膜药物层之前，FEP驻极体的非极化面需要粘合厚度约大于100 μm的聚三氟氯乙烯（PCTFE）或聚萘二甲酸乙二醇酯（PEN）等薄膜。
如图5所示，通过透过FEP驻极体极化面上的细胞培养基测得的表面电位值的曲线图表明，细胞培养基上的表面电位值约10 h后才降为0。因此，应用于本发明中的FEP驻极体可长效作用于面膜药物层作为物理促渗源，增强皮肤组织对面膜药物分子的吸收。
2. 面膜药物层
（1）面膜药物层的成分组成：染料木素(genistein) 1 wt%、甘油1 wt%、pH调节剂0.5 wt%、乳化剂10 wt%，剩余为去离子水；pH调节剂没有特别的限制，为本领域技术人员熟知；乳化剂为PEG-40氢化蓖麻油、PEG-60氢化蓖麻油、PPG-26-丁醇聚醚-26双-PEG-18甲基醚二甲基硅烷的组合物。
（2）面膜药物层的制备步骤：
①将染料木素和乳化剂加热至75 ℃，保温；
②将保湿剂加入水中，加热至75 ℃，保温；
③将步骤①产物加入步骤②中，保持75℃，以50 rpm的速率搅拌20 min；
④步骤③产物冷却至40 ℃，搅拌均匀，加入pH调节剂，调节pH至7.4，搅拌均匀；
⑤将面膜基层无纺布浸入步骤④产物30-60 min，取出即得面膜药物层。
3. 面膜的使用方法
参照图3，先将面部清洁干净，然后将面膜药物层敷于面部，然后再将驻极体层敷于面膜药物层上表面，维持30 min以上。
上述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所述实施例的限制，其他的任何未背离本发明的精神实质与原理下所作的改变、修饰、替代、组合、简化，均应为等效的置换方式，都包含在本发明的保护范围之内。
显然，本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。

Claims (10)

1、一种促进植物雌激素吸收的驻极体面膜，其特征在于，所述驻极体面膜包括驻极体层和面膜药物层，所述驻极体为聚合物材料极化处理得到，所述面膜药物层为面膜药物或者基层吸透面膜药物形成的片状层，所述驻极体层和面膜药物层分别独立包装，所述驻极体层采用电荷急剧衰减期后的驻极体。
根据权利要求1所述的驻极体面膜，其特征在于，所述驻极体的非极化面上粘接有支撑层；优选的，所述支撑层选自聚合物薄膜，优选的，所述聚合物薄膜包括PP、FEP、PCTFE、PEN。
根据权利要求1所述的驻极体面膜，其特征在于，所述驻极体的极化面上覆盖有隔离层；优选的，所述隔离层选自聚合物薄膜，优选的，所述聚合物薄膜包括FEP、PCTFE。
根据权利要求1所述的驻极体面膜，其特征在于，所述聚合物材料包括聚丙烯、氟化乙烯丙烯共聚物、聚四氟乙烯；所述基层包括无纺布、生物纤维、全棉布、蚕丝布。
根据权利要求1所述的驻极体面膜，其特征在于，所述聚合物材料的极化处理包括电晕充电法、电击穿充电法、液体接触充电法。
根据权利要求1所述的驻极体面膜，其特征在于，所述面膜药物，按重量份百分比计，包括大豆异黄酮0.01-5 wt%、保湿剂0.1-5 wt%、pH调节剂0.001-5 wt%、乳化剂5-10 wt%、水70-90 wt%。
根据权利要求6所述的驻极体面膜，其特征在于，所述保湿剂至少包括甘油、芦荟胶、透明质酸钠中的一种；所述pH调节剂至少包括乳酸和三乙醇胺中的一种；所述乳化剂至少包括PEG-40氢化蓖麻油、PEG-60氢化蓖麻油、PPG-26-丁醇聚醚-26双-PEG-18甲基醚二甲基硅烷中的一种。
根据权利要求1-7任意一项所述的驻极体面膜，其特征在于，驻极体面膜使用前，驻极体层和面膜药物层分别独立包装，驻极体面膜使用时，先将面膜药物层置于皮肤上，然后再将驻极体层置于面膜药物层上，驻极体层贴敷在面膜药物层上的时间大于30分钟。
根据权利要求8所述的驻极体面膜的制备方法，其特征在于，将驻极体层和面膜药物层制备后分别独立包装即得；
所述面膜药物层的制备，包括以下步骤：
（1）将大豆异黄酮和乳化剂加热至70-80 ℃，保温；
（2）将保湿剂加入水中，加热至70-80 ℃，保温；
（3）将步骤（1）产物加入步骤（2）中，保持温度在70-80 ℃，搅拌均匀；
（4）当温度冷却至40-50 ℃时，加入pH调节剂，调节pH值在4.0-8.0之间，搅拌均匀，获得膏状面膜药物即为面膜药物层；
或将基层吸透步骤（4）的膏状面膜药物形成的片状层即为面膜药物层。
所述驻极体层的制备，包括以下步骤：
①聚合物材料极化处理；
②电荷急速衰减期，所述驻极体层采用电荷急剧衰减期后的驻极体。
根据权利要求9所述的驻极体面膜的制备方法，其特征在于，步骤（3）和步骤（4）中，搅拌10-20 min，搅拌速率为30-60 rpm，步骤（4）①中，聚合物材料的极化处理包括电晕充电法、电击穿充电法、液体接触充电法。
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