A calming and anti-inflammatory polymer film and its preparation method

Abstract

The present invention relates to a calming and anti-inflammatory polymer film and a preparation method thereof, belonging to the field of biomaterial technology. The preparation method comprises: uniformly mixing a first polydimethylsiloxane, a second polydimethylsiloxane, and a third polydimethylsiloxane, a calming and anti-inflammatory active ingredient, water, an emulsifier, a preservative, and a thickener to obtain an emulsion; adding fumed silica to the emulsion to form a blend; then adding a pH regulator dropwise; adding hydroxyethyl cellulose to the resulting blend, and then adding a catalyst to obtain a base liquid; placing the obtained base liquid in a film mold, and evacuating the mold to obtain a calming and anti-inflammatory polymer film. The polymer film prepared by the present invention has good mechanical properties and can maintain appropriate tension in a natural state to adapt to the tension and pressure of the skin. At the same time, the film has sufficient elasticity during skin movement, which helps to restore the elastic recoil of the skin.

Description

Technical Field

[0001] The invention relates to the technical field of biomaterials, in particular to a calming and anti-inflammatory polymer film and a preparation method thereof. Background Art

[0002] The skin is the largest organ in the human body, accounting for approximately 16% of body weight. Its primary functions include protecting the body, dissipating perspiration, and sensing heat, cold, and pressure. Composed of three layers: the epidermis, dermis, and subcutaneous tissue, the skin covers the entire body. It protects various tissues and organs from physical, mechanical, chemical, and pathogenic microbial invasion. It prevents the loss of water, electrolytes, and other substances; it also blocks the intrusion of harmful external substances. However, the skin's protective layer is susceptible to damage, such as from exposure to ultraviolet rays, improper medication use, heat or cold, certain skin diseases, and external stimuli. These factors can disrupt the skin's barrier function.

[0003] Currently, solutions for skin loss are limited. For patients with impaired skin barrier function, treatment primarily relies on topical ointments and patches, but these approaches have limited effectiveness and are susceptible to patient compliance. In recent years, researchers have developed novel materials that restore the skin's elasticity lost due to recoil. However, because these materials cannot be worn invisibly to restore normal skin contraction and aesthetics, they are not suitable for designing a "second skin." Therefore, restoring skin elasticity loss remains a key concern.

[0004] Patent application publication number CN 114010539 A discloses a cosmetic biomimetic polymer film and its preparation method. This technical solution involves a hydrosilylation reaction between polydimethylsiloxane containing Si-H bonds and polydimethylsiloxane containing C=C under the action of a catalyst, resulting in a biomimetic matrix material with high mechanical properties. However, the elastic deformation and film-forming speed of this polymer film material still need to be improved. Patent application publication number CN 116549740 A discloses a bio-ink for DLP printing of biomimetic skin, its preparation, and application. This bio-ink is composed of two chemically modified skin ECM components. The resulting photocurable collagen (CoLMA) and photocurable chondroitin sulfate (CSMA) exhibit rapid photocuring gel formation and good biocompatibility, meeting the requirements of skin cell growth. The resulting gel has storage modulus and elastic modulus values ​​close to those of natural skin. However, this material is expensive and cannot meet the needs of most consumers. Therefore, preparing a bionic skin matrix material with high mechanical properties and low cost is an urgent problem we need to solve. Summary of the Invention

[0005] In response to the above-mentioned deficiencies in the prior art, the present invention provides a calming and anti-inflammatory polymer film, a preparation method thereof, and an application thereof; the film contains calming and anti-inflammatory active ingredients, which can form a film in situ to help damaged skin recover and reduce external stimulation to damaged skin, and can also simulate the appearance of normal young skin, thereby solving the problems of poor mechanical properties, long film-forming time, and high cost of existing bionic skin.

[0006] According to a first aspect of the present invention, there is provided a method for preparing a calming and anti-inflammatory polymer film, comprising the following steps:

[0007] (1) uniformly mixing the first polydimethylsiloxane, the second polydimethylsiloxane, the third polydimethylsiloxane, a sedative and anti-inflammatory active ingredient, water, an emulsifier, a preservative, and a thickener to obtain an emulsion;

[0008] (2) adding fumed silica to the emulsion obtained in step (1) to form a blend; and then adding a pH adjuster dropwise to adjust the pH value of the blend to 5.5 to 6.5;

[0009] (3) adding hydroxyethyl cellulose to the blend obtained in step (2), and then adding a catalyst to obtain a base liquid;

[0010] (4) placing the base liquid obtained in step (3) in a membrane mold and evacuating the mold to obtain a calming and anti-inflammatory polymer film;

[0011] Among them, the first polydimethylsiloxane and the second polydimethylsiloxane are PDMS1 and PDMS1' containing C=C bonds respectively, and the third polydimethylsiloxane is PDMS2 containing Si-H; the polydimethylsiloxanes containing C=C bonds and containing Si-H bonds undergo a hydrosilylation addition reaction under the action of a catalyst; the viscosity of the PDMS1 is 9~15 Pa·s, and the C=C bond content is 0.45~0.55 mmoles / g; the viscosity of the PDMS1' is 160~180 Pa·s, and the C=C bond content is 0.01~0.02 mmoles / g; the viscosity of the PDMS2 is 0.04~0.08 Pa·s, and the Si-H bond content is 4.15~4.55 mmoles / g.

[0012] Preferably, the mass ratio of the calming and anti-inflammatory active ingredient, the sum of the masses of the three polydimethylsiloxanes, fumed silica, water, emulsifier, thickener, preservative, hydroxyethyl cellulose, catalyst and pH regulator is (90-110):(65-95):(35-45):(160-200):(15-25):(5-20):(5-25):(10-12.5):(5-10):(1.5-2.5).

[0013] Preferably, the mass ratio of the first polydimethylsiloxane, the second polydimethylsiloxane, the third polydimethylsiloxane and the fumed silica is (13-18):(3-6):(2-8):(7-9).

[0014] Preferably, the catalyst is a transition metal catalyst.

[0015] Preferably, the catalyst is at least one of a platinum catalyst, a platinum-gold catalyst and a nickel catalyst.

[0016] Preferably, the calming and anti-inflammatory active ingredient is at least one of an anti-inflammatory and repairing ingredient, a soothing ingredient, an anti-allergic ingredient, and an anti-acne ingredient;

[0017] Preferably, the anti-inflammatory and repairing ingredient is at least one of bisabolol, vitamin B5, ectoine, calendula and peony;

[0018] Preferably, the soothing ingredient is at least one of guaiac wood, gentian, chamomile and witch hazel;

[0019] Preferably, the anti-allergic ingredient is at least one of aloe vera, purslane, glycyrrhizic acid and ceramide;

[0020] Preferably, the anti-acne ingredient is at least one of salicylic acid, fruit acid, mandelic acid, papain, fatty acyl salicylic acid, vitamin A and its derivatives, and fullerol.

[0021] Preferably, the emulsifier is one or more of KSG-240, FZ-2233 and Pemulen TR-2;

[0022] The preservative is one or more of phenoxyethanol, sodium chloride and caprylyl glycol;

[0023] The thickener is one or more of Ultrez 20, DC 9045, propylene glycol and butylene glycol.

[0024] Preferably, the pH adjuster is one or more of sodium bicarbonate solution, boric acid solution, sodium carbonate solution and sodium hydroxide solution.

[0025] Preferably, the hydroxyethyl cellulose is one or more of high-viscosity hydroxyethyl cellulose, medium-viscosity hydroxyethyl cellulose, and low-viscosity hydroxyethyl cellulose;

[0026] The viscosity of the high viscosity hydroxyethyl cellulose is 28000-38000mp . s, the viscosity of the medium viscosity hydroxyethyl cellulose is 4500-5500mp . s, the viscosity of the low viscosity hydroxyethyl cellulose is 250-450mp . s.

[0027] According to another aspect of the present invention, a calming and anti-inflammatory polymer film prepared by any one of the methods is provided.

[0028] In general, the above technical solutions conceived by the present invention have the following technical advantages compared with the existing technology:

[0029] (1) The present invention uses two types of polydimethylsiloxanes, one of which is PDMS1 and PDMS1' containing C=C bonds, and the other is PDMS2 containing Si-H. The PDMS containing C=C bonds and the PDMS containing Si-H undergo a hydrosilylation addition reaction under the action of a catalyst, wherein the molar ratio of C=C bonds to Si-H bonds is preferably 1:(1-1.1). The viscosity of the PDMS1 is 9-15 Pa·s, and the C=C bond content is 0.45-0.55 mmoles / g; the viscosity of the PDMS1' is 160-180 Pa·s, and the C=C bond content is 0.01-0.02 mmoles / g; the viscosity of the PDMS2 is 0.04-0.08 Pa·s, and the Si-H bond content is 4.15-4.55 mmoles / g. The coating performance and mechanical properties of the polymer film prepared by the present invention are improved by optimizing the viscosity, C=C bond and Si-H bond dosage of three main reactants, polydimethylsiloxane.

[0030] (2) The present invention uses hydroxyethyl cellulose as one of the components of the calming and anti-inflammatory polymer film. Its molecular structure has extremely strong adsorption properties, which can absorb the calming and anti-inflammatory active ingredients in the film and effectively transport them to the deep layers of the skin, thereby promoting wound healing. Secondly, it has a certain soothing and water-retaining effect, which can relieve inflammation and irritation of the skin and reduce skin discomfort.

[0031] (3) The present invention uses fumed silica as one of the components of the calming and anti-inflammatory polymer film. The presence of silanol groups on its surface significantly improves the mechanical properties of the product, and also improves the stability of the product and the skin feel during use.

[0032] (4) The polymer film prepared by the present invention has good mechanical properties and can maintain appropriate tension in its natural state to adapt to the tension and pressure of the skin. At the same time, the film has sufficient elasticity during skin movement, which helps to restore the elastic recoil of the skin.

[0033] (5) After being applied to the skin, the polymer film prepared by the present invention can form a thin film in situ - a safe "second skin", and the material has calming and anti-inflammatory ingredients that can calm the skin and tighten wounds in situ.

[0034] (6) The polymer film produced by the present invention is a thin and transparent covering layer that effectively protects damaged skin and is not easily detached or displaced from the skin. The polymer film produced by the present invention is compatible with human skin and does not cause any irritation or allergic reaction. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 Schematic diagram of the calming and anti-inflammatory polymer film of the present invention and its stretching diagram.

[0036] Figure 2 The storage modulus, loss modulus and viscosity of the calming and anti-inflammatory polymer film prepared in Example 1 of the present invention vary with angular frequency.

[0037] Figure 3-4 This is a test of the calming and anti-inflammatory performance of the calming and anti-inflammatory polymer film prepared in Example 1 of the present invention. DETAILED DESCRIPTION

[0038] In order to make the objectives, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely for the purpose of explaining the present invention and are not intended to limit the present invention. In addition, the technical features involved in the various embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.

[0039] The present invention features the use of hydroxyethyl cellulose as a component of the calming and anti-inflammatory polymer film. Its molecular structure possesses strong adsorption properties, effectively absorbing the calming and anti-inflammatory active ingredients in the film and effectively delivering them deep into the skin, thereby promoting wound healing. Furthermore, it possesses certain soothing and moisturizing properties, alleviating skin inflammation and irritation, and alleviating skin discomfort.

[0040] Therefore, the present invention discloses a calming and anti-inflammatory polymer film, the preparation steps of which are as follows:

[0041] (1) Mixing the first polydimethylsiloxane, the second polydimethylsiloxane, the third polydimethylsiloxane, the calming and anti-inflammatory active ingredient, water, an emulsifier, a preservative, and a thickener at room temperature;

[0042] (2) Adding fumed silica in small amounts and multiple times to the emulsion obtained in (1) under rapid stirring conditions, stirring evenly at room temperature; and then adding a pH regulator dropwise to adjust the pH value.

[0043] (3) adding hydroxyethyl cellulose to the blend obtained in (2), mixing and stirring at room temperature until uniform, and then adding a catalyst while stirring to obtain a base liquid;

[0044] (4) The base liquid obtained in step (3) is placed in a membrane mold, vacuumed and placed at room temperature for 12-16 hours to obtain a calming and anti-inflammatory polymer film.

[0045] The first and second polydimethylsiloxanes are PDMS1 and PDMS1', respectively, containing C=C bonds, and the third polydimethylsiloxane is PDMS2 containing Si-H bonds. The two PDMSs undergo a hydrosilylation addition reaction under the action of a catalyst. PDMS1 has a viscosity of 9-15 Pa·s and a C=C bond content of 0.45-0.55 mmoles / g; PDMS1' has a viscosity of 160-180 Pa·s and a C=C bond content of 0.01-0.02 mmoles / g; and PDMS2 has a viscosity of 0.04-0.08 Pa·s and a Si-H bond content of 4.15-4.55 mmoles / g.

[0046] In some embodiments, the molar ratio of the C═C bond to the Si—H bond is 1:(1 to 1.1).

[0047] The following are specific embodiments

[0048] Example 1

[0049] The method for preparing a calming and anti-inflammatory polymer film of the present invention is as follows:

[0050] (1) Add 1.3g PDMS1, 0.3g PDMS1', 0.2g PDMS2, 2g calming and anti-inflammatory active ingredients, 3.5g water, 0.5g thickener, 0.05g preservative and 0.3g emulsifier, and mix well at room temperature. Under rapid stirring, add 0.9g fumed silica in small amounts and stir well at room temperature. Then add 0.45g pH regulator dropwise to adjust the pH of the emulsion to 5.5-6.5, and then add 0.45g hydroxyethyl cellulose while stirring, mix well at room temperature to obtain a base liquid;

[0051] (2) Add 0.05 g of catalyst dropwise to the mixture obtained in step (1), mix well at room temperature, place in a film mold, evacuate, and leave at room temperature for 12-16 hours to obtain a calming and anti-inflammatory polymer film.

[0052] Except for the differences in the mass of PDMS1, PDMS1′, PDMS2, and fumed silica and the viscosity of hydroxyethyl cellulose, the specific parameters of other components remain the same between Examples 1-6 and Comparative Examples 1-5.

[0053] Table 1 Parameters of Examples and Comparative Examples

[0054]

[0055] Test Examples

[0056] Figure 1 Schematic diagram of the calming and anti-inflammatory polymer film prepared in Example 1 of the present invention and its stretching diagram.

[0057] Table 2 shows the film forming properties, water vapor transmission rates and mechanical properties of the examples and comparative examples prepared in the present invention.

[0058]

[0059]

[0060] As can be seen from Table 2, the film-forming speed of the materials obtained in Examples 1-3 and Example 6 is faster, and the film-forming time is 30-40s; the film-forming time of the materials obtained in Comparative Examples 3-5 is longer, and the film-forming time is 5-9min; and by comparing Comparative Example 1 with Example 1, it can be seen that too much fumed silica will cause the obtained material to be unable to form a film. As can be seen from Comparative Example 2 and Comparative Example 2, too much PDMS1' will also cause the obtained material to be unable to form a film. In addition, compared with Examples 1-3 and Comparative Examples 4-5, the addition of fumed silica and hydroxyethyl cellulose greatly improves the film-forming speed and the mechanical properties of the film. Therefore, it can be seen from the experiment that when the mass ratio of PDMS1, PDMS1', PDMS2, and fumed silica is (13-18): (3-6): (2-8): (7-9), a film can be formed.

[0061] The material obtained in Example 1 had the best water vapor transmission rate, at 3130 g / m².24h; the material obtained in Comparative Example 3 had the worst water vapor transmission rate, at 2040 g / m².24h. The storage modulus of Examples 1-6 and Comparative Examples 3-5 was greater than the loss modulus, indicating that the resulting materials all tended to be elastic solids. The storage modulus, also known as the elastic modulus, reflects the elasticity of a material. A higher storage modulus indicates better elastic properties and greater energy storage capacity. The loss modulus reflects the viscosity of a material. A higher loss modulus indicates greater viscosity.

[0062] In summary, it can be seen that the material obtained in Example 1 has the best mechanical properties.

[0063] Figure 2 The storage modulus, loss modulus and viscosity of the material obtained in Example 1 of the present invention vary with angular frequency.

[0064] The test results show that as the angular frequency increases, the storage modulus and loss modulus of the material obtained in Example 1 gradually increase, while the viscosity gradually decreases, indicating that it has good mechanical properties. The storage modulus is greater than the loss modulus, indicating that it is more similar to an elastic solid. Furthermore, compared with Figure 5 in Patent Publication No. CN 114010539A, the calming and anti-inflammatory polymer film prepared by the present invention exhibits superior mechanical properties.

[0065] Figure 3 This is the change in the transepidermal water loss (TEWL) value of the material obtained in Example 1 of the present invention.

[0066] TEWL indicates the water loss of the stratum corneum and can be used to detect whether the barrier function is intact; the lower the TEWL value, the less water is lost through the skin and the better the barrier function of the stratum corneum. Figure 3 It can be seen that during the observation period of 0-14 days, the TEWL value of the experimental group using the calming and anti-inflammatory polymer film was significantly lower than that of the control group.

[0067] Figure 4 This is the change in the skin erythema index (EI) of the material obtained in Example 1 of the present invention.

[0068] The EI value reflects the condition of facial capillaries and can directly reflect the degree of inflammation; the lower the EI value, the better the product is at repairing the skin and improving skin erythema reactions. Figure 4 It can be seen that during the observation period of 0-14 days, the EI value of the experimental group using the calming and anti-inflammatory polymer film was significantly lower than that of the control group.

[0069] It will be easily understood by those skilled in the art that the above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A method for preparing a calming and anti-inflammatory polymer film, characterized in that: The following steps are involved: (1) uniformly mixing the first polydimethylsiloxane, the second polydimethylsiloxane, the third polydimethylsiloxane, a sedative and anti-inflammatory active ingredient, water, an emulsifier, a preservative, and a thickener to obtain an emulsion; (2) adding fumed silica to the emulsion obtained in step (1) to form a blend; and then adding a pH adjuster dropwise to adjust the pH value of the blend to 5.5 to 6.5; (3) adding hydroxyethyl cellulose to the blend obtained in step (2), and then adding a catalyst to obtain a base liquid; (4) placing the base liquid obtained in step (3) in a membrane mold and evacuating the mold to obtain a calming and anti-inflammatory polymer film; The first and second polydimethylsiloxanes are PDMS1 and PDMS1' containing C=C bonds, respectively, and the third polydimethylsiloxane is PDMS2 containing Si-H bonds. The polydimethylsiloxanes containing C=C bonds and Si-H bonds undergo hydrosilylation under the action of a catalyst. The viscosity of the PDMS1 is 9-15 Pa. . s, C=C bond content is 0.45-0.55 mmoles / g; the viscosity of the PDMS1' is 160-180 Pa . s, C=C bond content is 0.01-0.02 mmoles / g; the viscosity of the PDMS2 is 0.04-0.08 Pa . s, Si-H bond content is 4.15 to 4.55 mmoles / g; The mass ratio of the first polydimethylsiloxane, the second polydimethylsiloxane, the third polydimethylsiloxane and the fumed silica is (13-18):(3-6):(2-8):(7-9).

2. The method for preparing the calming and anti-inflammatory polymer film according to claim 1, wherein: The mass ratios of the calming and anti-inflammatory active ingredients, the sum of the masses of the three polydimethylsiloxanes, fumed silica, water, emulsifier, thickener, preservative, hydroxyethyl cellulose, catalyst and pH regulator are (90-110):(65-95):(35-45):(160-200):(15-25):(5-20):(5-25):(10-12.5):(5-10):(1.5-2.5).

3. The method for preparing the calming and anti-inflammatory polymer film according to claim 1, wherein: The catalyst is a transition metal catalyst.

4. The method for preparing the calming and anti-inflammatory polymer film according to claim 3, wherein: The catalyst is at least one of a platinum catalyst, a platinum gold catalyst and a nickel catalyst.

5. The method for preparing the calming and anti-inflammatory polymer film according to claim 1, wherein: The calming and anti-inflammatory active ingredient is at least one of an anti-inflammatory and repairing ingredient, a soothing ingredient, an anti-allergic ingredient, and an anti-acne ingredient.

6. The method for preparing the calming and anti-inflammatory polymer film according to claim 5, wherein: The anti-inflammatory and repairing ingredient is at least one of bisabolol, vitamin B5, ectoine, marigold and peony.

7. The method for preparing the calming and anti-inflammatory polymer film according to claim 5, wherein: The soothing ingredient is at least one of guaiac wood, gentian, chamomile and witch hazel.

8. The method for preparing the calming and anti-inflammatory polymer film according to claim 5, wherein: The anti-allergic ingredient is at least one of aloe vera, purslane, glycyrrhizic acid and ceramide.

9. The method for preparing the calming and anti-inflammatory polymer film according to claim 5, wherein: The acne-removing ingredient is at least one of salicylic acid, fruit acid, mandelic acid, papain, fatty acyl salicylic acid, vitamin A and fullerol.

10. The method for preparing the calming and anti-inflammatory polymer film according to claim 1, wherein: The emulsifier is one or more of KSG-240, FZ-2233 and Pemulen TR-2; The preservative is one or more of phenoxyethanol, sodium chloride and caprylyl glycol; The thickener is one or more of Ultrez 20, DC 9045, propylene glycol and butylene glycol.

11. The method for preparing a calming and anti-inflammatory polymer film according to claim 1, wherein: The pH regulator is one or more of sodium bicarbonate solution, boric acid solution, sodium carbonate solution and sodium hydroxide solution.

12. The method for preparing the calming and anti-inflammatory polymer film according to claim 1, wherein: The hydroxyethyl cellulose is one or more of high-viscosity hydroxyethyl cellulose, medium-viscosity hydroxyethyl cellulose, and low-viscosity hydroxyethyl cellulose; The viscosity of the high viscosity hydroxyethyl cellulose is 28000-38000mp . s, the viscosity of the medium viscosity hydroxyethyl cellulose is 4500-5500mp . s, the viscosity of the low viscosity hydroxyethyl cellulose is 250-450mp . s.

13. A calming and anti-inflammatory polymer film prepared by the method according to any one of claims 1 to 12.

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