Scar removing cream for hyperplastic scars and preparation method thereof

Abstract

The scar removing cream is prepared from the following raw materials in percentage by weight: 30 to 80 percent of silica gel component, 5 to 30 percent of solvent, 0.1 to 10 percent of emulsifying agent, 1 to 5 percent of thickening agent, 0.01 to 10 percent of extract / synergistic component, 0.1 to 20 percent of medicament component, 1 to 50 percent of moisturizing component, 0.01 to 0.1 percent of growth factor, 0.1 to 2 percent of other component, 0.01 to 0.5 percent of preservative and 0.1 to 2 percent of pH (Potential of Hydrogen) regulator. The traditional Chinese medicine composition has the effects of improving skin repair, whitening and diminishing inflammation, accelerates skin elasticity recovery and reduces scars.

Description

Technical Field

[0001] The present invention belongs to the technical field of skin scar removal cream preparation, and relates to a scar removal cream for hypertrophic scars and a preparation method thereof. Background Art

[0002] When the body is injured and the skin is cut or damaged, it initiates a complex self-repair mechanism, and scars are often an inevitable product of this process. The formation of scars is actually the growth and remodeling of collagen under the skin during wound healing. Some wounds heal quietly with almost no trace; while others form obvious scars. In the initial stage of healing, scars are often red or dark in color and slightly raised, but over time, they may gradually become pale and flat. However, the visibility of scars is not entirely determined by the natural process of wound healing; it is also affected by various factors such as individual differences, type of injury, and time. For example, when scars persist for more than two months to two years, they tend to become more stubborn and difficult to treat. After two years of scar formation, surgical intervention may need to be considered, but this treatment method also comes with risks, such as the formation of new scars after surgery. Behind the formation of scars, there is a delicate balance between anabolism and catabolism. When this balance is disrupted, resulting in far more collagen production than its degradation, the phenomenon of excessive scar formation occurs. This abnormal healing process may lead to various types of scars, such as fibrosis, fibromatosis, keloids, etc., which not only affect the appearance of the skin but may also affect joint movement and the overall function of the body.

[0003] Currently, silicone gel products can be used as a treatment means in the field of scar repair. These products promote the healing process by providing a barrier function, which may involve various mechanisms such as increasing hydration, controlling pH, raising temperature, and controlling oxygen tension. Although silicone gel products have shown certain effects in scar repair, their use and effects also have certain limitations. For example, they cannot effectively improve the removal of hypertrophic scars, which are large lesions representing increased collagen fiber deposition. They have the same clinical appearance: they are red, raised, hard, and have a smooth, shiny surface. Hypertrophic scars can flatten spontaneously within one to several years, while keloids persist and extend beyond the original injury site. Keloids are masses of hyperplastic connective tissue that occur in the dermis and adjacent subcutaneous tissues, most commonly after trauma, in certain susceptible individuals. Keloid lesions are formed when local skin fibroblasts undergo intense hyperplasia and proliferation in response to local stimuli. The increase in scar size is due to an increase in the amount of collagen deposited in the tissue. In addition, there is also pigment deposition, resulting in a color difference in the scar area compared to other skin areas. Coupled with the fact that some symptoms such as redness, itching, and pain in scarred skin can be severe, the quality of life of patients can be significantly reduced for a long time, and few can effectively achieve the expected effect.

[0004] Therefore, we urgently need a more comfortable, less obvious silicone gel product that has a specific effect on various scars. This product should be able to more effectively reduce scar formation, while reducing the burden on patients and improving their quality of life. Summary of the Invention

[0005] In view of the deficiencies of the prior art, the present invention provides an anti-scar cream for hypertrophic scars and its preparation method, which can reduce hypertrophic scars and has good anti-inflammatory, whitening, skin care and other effects.

[0006] The technical solution provided by the present invention is as follows:

[0007] The present invention provides an anti-scar cream for hypertrophic scars, which is composed of the following raw materials, calculated by weight percentage: silicone gel component 30 - 80%, solvent 5 - 30%, emulsifier 0.1 - 10%, thickener 1 - 5%, extract / synergistic component 0.01 - 10%, pharmaceutical component 0.1 - 20%, moisturizing component 1 - 50%, growth factor 0.01 - 0.1%, other components 0.1 - 2%, preservative 0.01 - 0.5% and pH regulator 0.1 - 2%.

[0008] Further, the silicone gel component is selected from any one or a combination of polydimethylsiloxane, polysiloxane-11, polysiloxane-15, polysiloxane-8, polysiloxane-17, hydrogenated polydimethylsiloxane, dodecyl polydimethylsiloxane, cyclopentasiloxane, cyclohexasiloxane, trisiloxane, methyl trimethylsiloxane, phenylmethylsiloxane, polydimethylsiloxane copolyol, methyl polysiloxane, methyl polydimethylsiloxane, methyl polydioxane, methyl polysiloxane dimethyl polysiloxane, hexamethyldisiloxane, octylmethylpolysiloxane, dimethylsiloxane and dimethylsiloxane cross-linked polymer, polydimethylsiloxane cross-linked polymer, fumed silica.

[0009] Further, the emulsifier is selected from any one or a combination of Tween, Span, polyoxyethylene ether, betaine, polyethylene glycol fatty acid ester, glyceryl stearate, gum arabic, gelatin, lecithin, cholesterol, cetyl alcohol, cetearyl alcohol, sodium cetearyl sulfate, glycerol monostearate, methyl cellulose, sodium carboxymethyl cellulose, stearic acid, glycolipid, lipopeptide, phospholipid, lanolin, beeswax, sucrose ester, alkyl sulfate, alkyl phosphate, fatty alcohol polyoxyethylene ether carboxylate, alkenyl sulfonate, succinate sulfonate, alkyl glycerol ether sulfate, lauryl sulfonate, sodium lauryl sulfate, alkyl benzene sulfonate, fatty alcohol polyoxyethylene ether, fatty acid methyl ester ethoxylate, isomeric alcohol polyoxyethylene ether, lauryl dimethylamine oxide, myristyl dimethylamine oxide, dimethyl coconut amine oxide, coconut amide propyl dimethylamine oxide, C12-20 alkyl glucoside, beef tallow amide propyl dimethylamine oxide.

[0010] Further, the thickener is selected from any one or a combination of xanthan gum, carbomer, polyacrylic acid derivative, polyvinyl alcohol PVA, polyvinylpyrrolidone PVP, PVP / PVA copolymer, hydroxyethyl cellulose, acrylate polymer, alkyl acrylate cross-copolymer, hydrolyzed protein, cetearyl alcohol, plant polysaccharide, microbial polysaccharide, animal polysaccharide, carboxymethyl cellulose, methyl cellulose, alginate, sodium hyaluronate, chitin / chitosan, hyaluronic acid, collagen, pectin, gelatin, starch, starch copolymer.

[0011] Further, the extract / synergistic component is selected from snail mucin extract, mussel mucin, wild pansy extract, aloe leaf juice extract, sunflower seed oil extract, olive leaf extract, shea butter extract, rice germ extract, French rose rose extract, passion fruit extract, calendula extract, chamomile extract, lavender extract, arnica extract, Centella asiatica extract, horsetail extract, geranium extract, dandelion extract, rosemary flower extract, bamboo extract, green tea extract, forsythia extract, resorcinol derivatives, vitamin C, arbutin, kojic acid, ellagic acid, tranexamic acid, azelaic acid, glutathione, niacinamide, fruit acid, salicylic acid, vitamin A and its derivatives, ferulic acid, idebenone, resveratrol, astaxanthin, octocrylene, ethylhexyl methoxycinnamate, bis-ethylhexyloxyphenol methoxyphenyl triazine, titanium dioxide, zinc oxide, and laurocapron. Any one or a combination of these.

[0012] Furthermore, the solvent includes a volatile component, a hydrophilic solvent and a lipophilic solvent, the volatile component is selected from any one or a combination of isopropyl alcohol IPA, ethanol, methanol, acetone, low molecular weight silicone, cyclomethicone, volatile silicone or silicone solvent, ethoxydiglycol, and hexane, the hydrophilic solvent is selected from any one or a combination of purified water, saline, Ringer's solution, ethanol, propylene glycol, glycerol, polyethylene glycol, and polyethylene glycol, and the lipophilic solvent is selected from any one or a combination of olive oil, peanut oil, sesame oil, camellia oil, rapeseed oil, fatty acid monoglycerides, fatty acid diglycerides, higher fatty acid esters, and liquid paraffin.

[0013] Further, the pharmaceutical component is selected from tamoxifen citrate, alclomethasone dipropionate, amcinonide, betamethasone dipropionate, betamethasone sodium phosphate, betamethasone valerate, budesonide, clobetasol-17-propionate, clobetasone-17-butyrate, cortisone acetate, desonide, dexamethasone, dexamethasone sodium phosphate, fluocinolone acetonide, fluocinolone, flucortolone, flucortolone caproate, flucortolone pivalate, fluprednione acetate, halcinonide, hydrocortisone, hydrocortisone acetate, hydrocortisone-17-butyrate Ester, hydrocortisone-17-valerate, methylprednisolone, mometasone, prednicacid ester, prednisolone, prednisone, tisocotor pivalate, triamcinolone acetonide, triamcinolone acetonide alcohol or one or more combinations thereof; the drug delivery carrier is selected from any one or more combinations thereof selected from corticosteroids, antipsoriatic drugs, arnica, chloroacetic acid, methionine, aluminum chloride hexahydrate, collagenase, hyaluronidase, ketone solvents, minoxidil, psoralen, hydroquinone and monobenzophenone, 5-FU, retinoids, urea, dexpanthenol, and vitamin E.

[0014] Furthermore, the moisturizing component is selected from one or more combinations of glycerol, propylene glycol, sunflower oil, glyceryl stearate, glycerol stearate, stearyl glycyrrhetinate, esterified VC, ascorbic acid (fine powder), senna seeds, retinol, jojoba oil, macadamia seed oil, and panthenol (vitamin B5), allantoin, coconut oil, olive fruit oil, sunflower seed oil, cocoa butter, shea butter, dimethyl isosorbide, cetyl, almond oil, olive oil, peach kernel oil, peanut oil, castor oil.

[0015] Furthermore, the pH regulator is selected from any one or more combinations of sodium hydroxide, potassium hydroxide, carbonates, bicarbonates, boric acid, borax, potassium dihydrogen phosphate, disodium hydrogen phosphate, lactic acid, triethanolamine, aminomethyl propanol, AMP-95, diethanolamine (DEA), methyldiethanolamine (MDEA), phosphoric acid, citric acid, malic acid, tartaric acid, glycolic acid, mandelic acid, acetic acid.

[0016] Furthermore, the preservative component is selected from any one or more combinations of phenoxyethanol, benzyl alcohol, ethanol, chlorobutanol, imidazolidinyl urea, diazolidinyl urea, sodium hydroxymethylglycinate, methylparaben, phenol, sorbic acid, salicylic acid, dehydroacetic acid, sodium benzoate, DMDM hydantoin, methylisothiazolinone.

[0017] Furthermore, the growth factor component is selected from one or more combinations of transforming growth factor α (TGF-α), transforming growth factor β (TGF-β) and its regulators, platelet-derived growth factor (PDGF), basic fibroblast growth factor (bFGF), nerve growth factor (NGF), neurotrophin 3 (NT3), brain-derived neurotrophic factor (BDGF), keratinocyte growth factor, blood-derived growth factor, epidermal growth factor (EGF), heparin-binding epidermal growth factor (HB-EGF), fibroblast growth factor (FGF), estradiol, ethinylestradiol, diethylstilbestrol, tolclofos, estriol, conjugated estrogen, piperazine estrone sulfate, stilbestrol, phosphosphingolipid, polyestradiol phosphate, tibolone, phytoestrogen, thymosin, tumor necrosis factor (TNF), interleukin (IL) and its regulators, interferon (INF), stimulator of activin or inhibin, inhibitor of prostaglandin E2 (PGE2), mediator of adenosine 3′,5′-cyclic phosphate (cAMP) pathway, adenosine A agonist, hedgehog signaling regulator, cholesterol synthesis pathway regulator, vascular endothelial growth factor (VEGF), insulin-like growth factor (IGF) and its antagonist, pro-inflammatory cytokine, colony-stimulating factor (GM-CSF), leptin, keratinocyte growth factor (KGF) cDNA, autologous platelet gel, lipoic acid, nitric oxide synthase 3 (NOS3), matrix metalloproteinase 9 (MMP-9), chaperonin (CCT-ETA), αvbeta6 integrin, placental alkaline phosphatase (PLAP), placental growth factor (PLGF), activated protein C (APC), thromboxane A2, bone morphogenetic protein (BMP), connective tissue growth factor (CTGF).

[0018] Specifically, PDGF-AA, PDGF-AB, or PDGF-BB can be used for platelet-derived growth factor (PDGF); TGF-β1, TGF-β2, or TGF-β3 can be used for transforming growth factor β (TGF-β); mannose-6-phosphate, which is a factor that regulates the relative levels of TGF-β1, TGF-β2, and TGF-β3, can be used for the regulator of TGF-β; thymosin-β-4 can be used for thymosin; FGF1, FGF2, or FGF7 can be used for fibroblast growth factor (FGF); IL-1, IL-2, IL-6, IL-8, or IL-10 can be used for interleukin (IL); IFN-α, IFN-β, IFN-δ, or IFN-γ can be used for interferon (INF); adenosine A1 agonist, adenosine A2 agonist, or adenosine A5 agonist can be used for adenosine A agonist.

[0019] The present invention also provides a method for preparing a scar-removing cream for hypertrophic scars, comprising the following steps: Mix the siloxane components and stir to form a uniform silicone gel matrix; Dissolve the thickener in a solvent to form a colloid and add it to the silicone gel matrix. Then, sequentially add an emulsifier, a humectant, a pharmaceutical component, an extract, and a drug delivery carrier, and mix and stir until uniform to obtain a mixture; Add a pH regulator to adjust the pH of the mixture to 5 - 6, and add a preservative; Perform high-pressure homogenization treatment and vacuum degassing treatment on the mixture; Fill the homogenized product into a container and let it stand and solidify to form the scar-removing cream.

[0020] Beneficial effects

[0021] The composition of a scar-removing cream for hypertrophic scars provided by the present invention is based on a silicone gel and is compounded with an extract, and is also assisted by drugs and growth factors. It has the following effects: 1) Improve the repair effect: Compounding the extract on the basis of the silicone gel can enhance the repair function of the scar-removing cream. The active ingredients in the extract can penetrate deep into the skin, stimulate cell regeneration, and promote the repair of damaged tissues; 2) Adding components such as extracts in the formula enhances the whitening effect: Some extracts in the scar-removing cream contain whitening ingredients, which can inhibit the formation of melanin, reduce pigmentation in the scar area, and thus make the scar less obvious; 3) Adding special anti-inflammatory components strengthens the anti-inflammatory effect: Inflammation is one of the important factors in scar formation. The anti-inflammatory components in the scar-removing cream can reduce the inflammatory response, reduce the possibility of scar formation, and contribute to the fading of the scar; 4) Accelerate the skin's recovery of elasticity by adding auxiliary drugs and growth factors: The scar-removing cream can promote the synthesis of collagen, accelerate the recovery of the skin's elasticity, and make the scar area smoother. Description of the drawings

[0022] Figure 1 It is a comparison diagram before and after scar repair in Example 3 of the present invention. Detailed implementation manners

[0023] The present invention will be further described below. The following examples are only used to more clearly illustrate the technical solutions of the present invention and cannot be used to limit the protection scope of the present invention.

[0024] In the ranges disclosed herein, the endpoints and any values are not limited to the exact ranges or values. These ranges or values should be understood to include values close to these ranges or values. For numerical ranges, between the endpoint values of each range, between the endpoint values of each range and individual point values, and between individual point values, they can be combined with each other to obtain one or more new numerical ranges, and these numerical ranges should be regarded as specifically disclosed herein.

[0025] For the purposes of this specification and the appended claims, unless otherwise stated, all numbers expressing quantities, percentages or proportions, and other numerical values used in this specification and the appended claims are understood to be modified in all instances by the term "about". In addition, all ranges disclosed herein include the endpoints and are combinable independently.

[0026] Example 1

[0027] For general hypertrophic scars, a scar-removing cream provided in Example 1 of the present invention is composed of the following raw materials by weight percentage: silicone gel component: silicone elastomer Dow Corning 9041 (57%) and low-viscosity silicone oil DC 200 0.65 cSt (11.14%); solvent: propylene glycol (6%); emulsifier: C12-20 alkyl glucoside (4.8%); thickener: xanthan gum (2%); extract / synergistic component: sunflower seed oil extract (5%) and aloe vera leaf juice extract (0.1%); pharmaceutical component: desonide (0.19%); drug delivery carrier: urea (0.01%); moisturizing component: ascorbic acid fine powder (5%), esterified VC (6%) and stearyl glycyrrhetinate (0.5%); growth factor: basic fibroblast growth factor bFGF (0.01%); preservative: benzyl alcohol (0.05%); pH regulator: lactic acid (1%); other components: laurocapram (0.3%), caprylic / capric triglyceride (0.5%) and squalane (0.4%).

[0028] The preparation method of the scar-removing cream includes the following steps:

[0029] 1. Preparation stage

[0030] Weigh materials: Use an electronic balance to accurately weigh all raw materials, ensuring accuracy to at least two decimal places.

[0031] Equipment cleaning and disinfection: Ensure that all equipment in contact with the product (such as stirrers, containers, heaters, etc.) is clean and free of contamination, and perform high-level steam treatment or sterilization if necessary.

[0032] 2. Preparation of silicone gel base

[0033] Mix the silicone gel components: Add the silicone elastomer Dow Corning 9041 and low-viscosity silicone oil (10%) to a clean container, and use a planetary mixer or high-speed disperser to stir at low speed for 10 - 15 minutes at room temperature (20 - 25°C) until a uniform mixture is formed, avoiding the generation of bubbles.

[0034] 3. Add relevant active ingredients

[0035] Thickener treatment: Dissolve xanthan gum in part of propylene glycol in advance. After forming a uniform colloid, slowly add it to the silica gel mixture and continue stirring for 5 minutes to ensure complete dispersion.

[0036] Solvent and emulsifier: Add part of propylene glycol and C12-20 alkyl glucoside and stir until evenly mixed (about 5 minutes).

[0037] Humectant: Add ascorbic acid fine powder, esterified VC, and stearyl glycyrrhetate in sequence and stir at low speed for 5 minutes to ensure no lumps.

[0038] Pharmaceutical components: Dissolve desonide and urea in a small amount of propylene glycol, slowly add it to the mixture, and stir for 10 minutes.

[0039] Extracts / synergistic components: Dissolve sunflower seed oil extract and aloe vera leaf juice extract in a small amount of propylene glycol, slowly add it to the mixture, and stir for 5 minutes.

[0040] Other components: Add azone, caprylic / capric triglyceride, and squalane in sequence and continue stirring for 5 minutes.

[0041] Drug delivery carrier and growth factor: Dissolve growth factor bFGF in sterile water, slowly add it to the mixture, and homogenize for 5 minutes.

[0042] 4. Adjust pH and preserve

[0043] pH adjustment: Slowly add lactic acid and monitor with a pH meter while adding until the pH is adjusted to 5.5.

[0044] Add preservative: Add benzyl alcohol and stir for 2 minutes to ensure uniform dispersion.

[0045] 5. Homogenize and degas

[0046] High-pressure homogenization: Use a high-pressure homogenizer to homogenize the mixture (pressure 10-20 MPa, time 10-20 minutes) to reduce particle size and improve stability.

[0047] Vacuum degassing: Remove air bubbles through a vacuum degasser, control the temperature below 40°C, and the treatment time is 10-15 minutes.

[0048] 6. Fill and solidify

[0049] Filling: Quickly fill the treated scar removal cream into a pre-sterilized container to avoid re-introducing air bubbles.

[0050] Solidification: Seal and leave it in a cool environment (below 25°C) for 24 hours to ensure the stability of the system.

[0051] Example 2

[0052] For hypertrophic and hyperplastic scars, an anti-scar cream provided by Example 2 of the present invention, calculated by weight percentage, is composed of the following raw materials: Silicone gel component: polydimethylsiloxane (45%), fumed silica (5%), polydimethylsiloxane cross-linked polymer (5%) and cyclopentasiloxane (21.84%); Solvent: propylene glycol (5%); Emulsifier: cetearyl alcohol (2%); Thickener: sodium hyaluronate (0.2%), xanthan gum (5%); Extract / synergistic component: olive leaf extract (0.1%); Medicament component: hydrocortisone acetate (2%), tamoxifen citrate (0.1%); Drug delivery carrier: vitamin E (0.5%); Moisturizing ingredient: dimethyl isosorbide (6%); Growth factor: nerve growth factor NGF (0.01%); Preservative: benzyl alcohol (0.05%); pH regulator: lactic acid (1%); Other components: laurocapram (0.3%), caprylic / capric triglyceride (0.5%), squalane (0.4%).

[0053] The preparation method of the anti-scar cream includes the following steps:

[0054] 1. Preparation stage

[0055] Weighing materials: Use an electronic balance to accurately weigh all raw materials, accurate to two decimal places.

[0056] Equipment disinfection: Perform high-temperature sterilization treatment on equipment such as stirrers, containers, and homogenizers.

[0057] 2. Preparation of silicone gel base

[0058] Add polydimethylsiloxane, fumed silica, polydimethylsiloxane cross-linked polymer (5%) and cyclopentasiloxane into a clean container.

[0059] Use a planetary stirrer to stir at low speed for 15 minutes at 20 - 25 °C to form a uniform mixture.

[0060] 3. Adding active ingredients

[0061] Thickener treatment: Pre-dissolve xanthan gum and sodium hyaluronate in part of propylene glycol, form a colloid and then add it to the mixture, and continue stirring for 5 minutes.

[0062] Solvent and emulsifier: Add propylene glycol and cetearyl alcohol, and stir for 5 minutes until evenly mixed.

[0063] Humectant: Add dimethyl isosorbide and stir at low speed for 5 minutes to ensure no lumps.

[0064] Drug delivery: Add hydrocortisone acetate, tamoxifen citrate and vitamin E in sequence, and stir at low speed for 10 minutes.

[0065] Extract / Enhancing Component: Dissolve olive leaf extract in a small amount of propylene glycol, slowly add it to the mixture, and stir for 5 minutes.

[0066] Other Components: Add laurocapram, caprylic / capric triglyceride, and squalane, and stir until completely dispersed.

[0067] Growth Factor: Dissolve growth factor NGF in sterile water and then add it, and homogenize for 5 minutes.

[0068] 4. Adjust pH and Antiseptic

[0069] Slowly add lactic acid, and monitor and adjust the pH to 5.5 in real time.

[0070] Add benzyl alcohol and stir for 2 minutes to ensure uniformity.

[0071] 5. Homogenization and Degassing

[0072] Use a high-pressure homogenizer (pressure 10 - 20 MPa) to process for 20 minutes to improve stability.

[0073] Vacuum degassing (below 40°C) to remove air bubbles, and process for 15 minutes.

[0074] 6. Filling and Solidifying

[0075] Fill the scar-removing cream into a sterilized container, seal it, and let it stand in a cool environment at 25°C for 24 hours.

[0076] Example 3

[0077] For hypertrophic scars with pigment deposition, a scar-removing cream for hypertrophic scars provided by Example 3 of the present invention is composed of the following raw materials by weight percentage: Silicone Gel Component: Silicone elastomer Dow Corning 9041 (57%) and polydimethylsiloxane (10%); Solvent: Propylene glycol (5%); Emulsifier: Betaine (3%); Thickening Agent: Xanthan gum (5%), Sodium hyaluronate (0.5%); Moisturizing Component: Glycerol (5%); Extract / Enhancing Component: Snail mucin extract (5%), Rice germ extract, Octocrylene (3%); Medicament Component: Arbutin (2%), Niacinamide (0.1%); Drug Delivery Carrier: Vitamin E (2%); Other Components: Laurocapram (0.3%), Caprylic / capric triglyceride (0.5%) and Squalane (0.4%); Growth Factor: Basic fibroblast growth factor bFGF (0.05%); Preservative: Benzyl alcohol (0.05%); pH Regulator: Lactic acid (1%, adjust the pH to 5.5).

[0078] The preparation method of the scar-removing cream includes the following steps:

[0079] 1. Preparation Stage

[0080] Weighing materials: All raw materials were accurately weighed using an electronic balance (accuracy ± 0.01 g).

[0081] Equipment sterilization: Use high-temperature steam to sterilize agitators, containers, etc.

[0082] 2. Silicone Gel Base Preparation

[0083] Mix the silicone elastomer with polydimethylsiloxane and stir at low speed for 15 minutes at 25°C.

[0084] 3. Add active ingredients

[0085] Thickener treatment: Dissolve xanthan gum and sodium hyaluronate in part of propylene glycol in advance, add to the mixture after forming a colloid, and continue stirring for 5 minutes.

[0086] Solvents and emulsifiers: Add propylene glycol and betaine and stir for 5 minutes.

[0087] Humectant: Add glycerin and mix on low speed for 5 minutes, making sure there are no lumps.

[0088] Drug delivery: Add arbutin, niacinamide and vitamin E in sequence and stir at low speed for 10 minutes.

[0089] Extracts / Enhancing Ingredients: Dissolve snail mucin, rice germ extract, and octocrylene in a small amount of propylene glycol, slowly add to the mixture, and stir for 5 minutes.

[0090] Other ingredients: Add laurocaprylate, caprylic / caprylic triglyceride, and squalane and stir until fully dispersed.

[0091] Growth factors: Dissolve bFGF in sterile water and add slowly to the mixture, homogenize for 5 minutes.

[0092] 4. pH adjustment and preservation

[0093] Lactic acid was added to adjust the pH to 5.5, and then benzyl alcohol was added.

[0094] 5. Homogenization and degassing

[0095] High pressure homogenization (15 MPa, 20 min) and vacuum degassing (40 °C, 15 min).

[0096] 6. Filling and curing

[0097] Fill into sterile containers and let stand at 25°C for 24 hours.

[0098] Scar treatment effect evaluation:

[0099] To evaluate the scar treatment effect, identical scars were created on five mice, and the size of the scars was measured. The compositions of Examples 1, 2, and 3 and commercial products A / B were applied to the scar sites once every three days for two months. The results of evaluating the scar treatment effect are shown in Table 1 below, where the size of the scar was measured after 2 months, and the size of the scar after application was calculated as a percentage of the size of the scar before application.

[0100] Table 1

[0101]

[0102] It can be seen that Examples 1 / 2 / 3 of the present invention have significantly improved the effect on scars compared to some existing products A / B.

[0103] Test on the effect of improving skin viscoelasticity

[0104] To confirm whether the formulation of the present invention has the effect of improving skin viscoelasticity, the skin viscoelasticity of the back of the hand was measured using a skin viscoelasticity measuring device Cutometer MPA580 (Courage+Khazaka, Germany). The measurement was carried out by the following method, and the test results are shown in Table 2.

[0105] Test preparation:

[0106] (1) Ensure that the test instrument is calibrated and in working condition.

[0107] (2) Check the cleanliness and integrity of the test probe.

[0108] (3) Place the test subject in suitable environmental conditions, such as controlling the temperature at 20°C or 25°C and the relative humidity at 40% - 60%, to avoid the influence of the environment on the test results.

[0109] (4) The test subject needs to enter the test environment 30 minutes in advance, keep the whole body relaxed, and preferably adopt a lying position.

[0110] (5) The test subjects (6 age groups, 30 subjects in their 20s, 30s, and 40s).

[0111] Test procedure:

[0112] (1) Place the test probe on the selected skin site, such as the back of the hand, the inner side of the forearm, etc.

[0113] (2) Start the test instrument to generate a negative pressure on the surface of the skin to be tested, and suck the skin into the test probe. This negative pressure is usually in the range of 2 - 50 kPa.

[0114] (3) Negative pressure causes the skin to stretch, and the depth to which the skin is sucked into the probe is measured by a non-contact optical test system. The test probe includes a light emitter and a receiver, and the ratio of light (the ratio of emitted light to received light) is proportional to the depth of skin suction.

[0115] (4) The instrument records the relationship curve between the length of skin stretch and time, and this curve reflects the elastic properties of the skin.

[0116] Data analysis:

[0117] (1) The test data is processed and analyzed using the software attached to the instrument (such as MPA software).

[0118] (2) The main measurement indicators include the maximum skin stretch (Uf), the elastic part stretch (Ue), and the plastic part stretch (Uv).

[0119] A. Uf represents the maximum skin stretch.

[0120] B. Ue represents the skin stretch at 0.1 seconds after a constant negative pressure is applied to the skin, reflecting the elastic part stretch of the skin.

[0121] C. Uv represents the difference between Uf and Ue, reflecting the viscoelastic or plastic part stretch of the skin.

[0122] (3) For young and elastic skin, the value of Ue is usually higher; for old and inelastic skin, the value of Ue is lower, while the value of Uv is higher. R2 = Ue / Uf, and the larger R2 is, the better the skin elasticity.

[0123] Table 2

[0124]

[0125] Therefore, it has been confirmed that through the preparation of the present invention, a physiologically preferred therapeutic effect, namely the rejuvenation effect of the skin, can be obtained. The effects before and after scarring in Example 3 are as Figure 1 shown.

[0126] The above is only the preferred embodiment of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the technical principle of the present invention, several improvements and modifications can be made, and these improvements and modifications should also be regarded as the protection scope of the present invention.

Claims

1. A scar removal cream for hypertrophic scars, characterized in that: It is composed of the following raw materials, calculated by weight percentage: 30-80% silicone gel component, 5-30% solvent, 0.1-10% emulsifier, 1-5% thickener, 0.01-10% extract / synergist component, 0.1-20% pharmaceutical component, 1-50% moisturizing ingredient, 0.01-0.1% growth factor, 0.1-2% other components, 0.01-0.5% preservative and 0.1-2% pH adjuster.

2. The scar removing cream for hypertrophic scars according to claim 1, characterized in that: The silicone gel component is selected from any one or a combination of dimethicone, polysilicone-11, polysilicone-15, polysilicone-8, polysilicone-17, hydrogen dimethicone, dodecyl dimethicone, cyclopentasiloxane, cyclohexasiloxane, trisiloxane, methyl trimethicone, phenyl methylsiloxane, dimethicone copolyol, methyl polysiloxane, methyl dimethicone, methyl polydioxane, methyl polysilicone dimethicone, hexamethyldisiloxane, octyl methyl polysiloxane, dimethicone and dimethicone crosspolymer, dimethicone crosspolymer, and fumed silica.

3. The scar removing cream for hypertrophic scars according to claim 1, characterized in that: The emulsifier is selected from any one or a combination of Tween, Span, polyoxyethylene ether, betaine, polyethylene glycol fatty acid ester, glyceryl stearate, gum arabic, gelatin, lecithin, cholesterol, cetyl alcohol, cetearyl alcohol, sodium cetearyl sulfate, glyceryl monostearate, methylcellulose, sodium carboxymethyl cellulose, stearic acid, glycolipids, lipopeptides, phospholipids, lanolin, beeswax, sucrose esters, alkyl sulfates, alkyl phosphates, fatty alcohol polyoxyethylene ether carboxylates, olefin sulfonates, succinate sulfonates, alkyl glyceryl ether sulfates, lauryl alcohol sulfonates, sodium dodecyl sulfate, alkylbenzene sulfonates, fatty alcohol polyoxyethylene ethers, fatty acid methyl ester ethoxylates, isomeric alcohol polyoxyethylene ethers, lauryl dimethyl amine oxide, myristyl dimethyl amine oxide, dimethyl coconut amine oxide, cocamidopropyl dimethyl amine oxide, C12-20 alkyl glucoside, and tallow amide propyl dimethyl amine oxide.

4. The scar removing cream for hypertrophic scars according to claim 1, characterized in that: The thickener is selected from any one or a combination of xanthan gum, carbomer, polyacrylic acid derivatives, polyvinyl alcohol PVA, polyvinyl pyrrolidine PVP, PVP / PVA copolymer, hydroxyethyl cellulose, acrylate polymer, alkyl acrylate cross copolymer, hydrolyzed protein, cetearyl alcohol, plant polysaccharides, microbial polysaccharides, animal polysaccharides, carboxymethyl cellulose, methyl cellulose, alginate, sodium hyaluronate, chitin / chitosan, hyaluronic acid, collagen, pectin, gelatin, starch, and starch copolymers.

5. The scar removing cream for hypertrophic scars according to claim 1, characterized in that: The extract / synergistic component is selected from snail mucin extract, mussel mucin, wild pansy extract, aloe leaf juice extract, sunflower seed oil extract, olive leaf extract, shea butter extract, rice germ extract, French rose rose extract, passion fruit extract, calendula extract, chamomile extract, lavender extract, arnica extract, Centella asiatica extract, horsetail extract, geranium extract, dandelion extract, rosemary flower extract, bamboo extract, green tea extract, forsythia extract, resorcinol derivatives, vitamin C, arbutin, kojic acid, ellagic acid, tranexamic acid, azelaic acid, glutathione, niacinamide, fruit acid, salicylic acid, vitamin A and its derivatives, ferulic acid, idebenone, resveratrol, astaxanthin, octocrylene, ethylhexyl methoxycinnamate, bis-ethylhexyloxyphenol methoxyphenyl triazine, titanium dioxide, zinc oxide, and laurocapron. Any one or a combination of the above.

6. The scar removing cream for hypertrophic scars according to claim 1, characterized in that: The solvent includes a volatile component, a hydrophilic solvent and a lipophilic solvent, wherein the volatile component is selected from any one or a combination of isopropyl alcohol (IPA), ethanol, methanol, acetone, low molecular weight silicone, cyclomethicone, volatile silicone or silicone solvent, ethoxydiglycol, and hexane; the hydrophilic solvent is selected from any one or a combination of purified water, saline, Ringer's solution, ethanol, propylene glycol, glycerol, polyethylene glycol, and polyethylene glycol; and the lipophilic solvent is selected from any one or a combination of olive oil, peanut oil, sesame oil, camellia oil, rapeseed oil, fatty acid monoglyceride, fatty acid diglyceride, higher fatty acid ester, and liquid paraffin.

7. The scar removing cream for hypertrophic scars according to claim 1, characterized in that: The pharmaceutical component is selected from tamoxifen citrate, alclomethasone dipropionate, amcinonide, betamethasone dipropionate, betamethasone sodium phosphate, betamethasone valerate, budesonide, clobetasol-17-propionate, clobetasone-17-butyrate, cortisone acetate, desonide, dexamethasone, dexamethasone sodium phosphate, fluocinolone acetonide, fluocinolone, flucortolone, flucortolone caproate, flucortolone pivalate, fluprednione acetate, halcinonide, hydrocortisone, hydrocortisone acetate, One or more combinations of hydrocortisone-17-butyrate, hydrocortisone-17-valerate, methylprednisolone, mometasone, prednicacid ester, prednisolone, prednisone, tisocotor pivalate, triamcinolone acetonide, and triamcinolone acetonide alcohol; the drug delivery carrier is selected from any one or more combinations of corticosteroids, anti-psoriatic drugs, arnica, chloroacetic acid, methionine, aluminum chloride hexahydrate, collagenase, hyaluronidase, ketone solvents, minoxidil, psoralen, hydroquinone and monobenzophenone, 5-FU, retinoids, urea, dexpanthenol, and vitamin E.

8. The scar removing cream for hypertrophic scars according to claim 1, characterized in that: The moisturizing component is selected from one or more combinations of glycerin, propylene glycol, sunflower oil, glyceryl stearate, glyceryl stearate, stearyl glycyrrhetinate, esterified VC, ascorbic acid (fine powder), senna seeds, retinol, jojoba oil, macadamia seed oil and panthenol (vitamin B5), allantoin, coconut oil, olive oil, sunflower seed oil, cocoa butter, shea butter, dimethyl isosorbide, spermaceti, almond oil, olive oil, peach kernel oil, peanut oil and castor oil.

9. The scar removing cream for hypertrophic scars according to claim 1, characterized in that: The growth factor component is selected from transforming growth factor α (TGF-α), transforming growth factor β (TGF-β) and its regulators, platelet-derived growth factor (PDGF), basic fibroblast growth factor (bFGF), nerve growth factor (NGF), neurotrophic factor 3 (NT3), brain-derived neurotrophic factor (BDGF), keratinocyte growth factor, blood-derived growth factor, epidermal growth factor (EGF), heparin-binding epidermal growth factor (HB-EGF), fibroblast growth factor (FGF), estradiol, ethinyl estradiol, diestradiol, toluene, estriol, conjugated estrogens, piperazine estrone sulfate, stilbene, phospholipidol phosphate, polyestradiol phosphate, tibolone, phytoestrogens, thymic hormones, tumor One or more combinations of necrosis factor (TNF), interleukin (IL) and its regulators, interferon (INF), stimulators of activin or inhibin, inhibitors of prostaglandin E2 (PGE2), mediators of adenosine 3′, 5′-cyclic monophosphate (cAMP) pathway, adenosine A agonists, hedgehog signal transduction regulators, cholesterol synthesis pathway regulators, vascular endothelial growth factor (VEGF), insulin-like growth factor (IGF) and its antagonists, proinflammatory cytokines, colony stimulating factor (GM-CSF), leptin, keratinocyte growth factor (KGF) cDNA, autologous platelet gel, lipoic acid, nitric oxide synthase 3 (NOS3), matrix metalloproteinase 9 (MMP-9), chaperone (CCT-ETA), αvbeta6 integrin, placental alkaline phosphatase (PLAP), placental growth factor (PLGF), activated protein C (APC), thromboxane A2, bone morphogenetic protein (BMP), connective tissue growth factor (CTGF).

10. A method for preparing a scar removing cream for hypertrophic scars, characterized in that: The following steps are involved: The silicone components are mixed and stirred to form a uniform silicone gel matrix; The thickener is dissolved in a solvent to form a colloid, and then the silicone gel matrix is ​​added, and then an emulsifier, a moisturizer, a pharmaceutical component, an extract and a drug delivery carrier are added in sequence, and mixed and stirred until a uniform mixture is obtained; A pH regulator is added to adjust the pH of the mixture to 5-6, and a preservative is added; The mixture is subjected to high pressure homogenization and vacuum degassing; The homogenized product is filled into a container and allowed to stand and solidify to form the scar removing cream.

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