A scar paste and its preparation method and application

Abstract

This invention provides a scar cream, its preparation method, and its application, comprising the following components in weight percentage: silicone: 5-30%; carbomer: 0.01-0.10%; propylene glycol: 1-10%; emulsifier: 2.5-15%; oat core repair factor: 0.2-5%; ascorbic acid tetraisopalmitate: 0.2-2%; centella asiatica extract: 0.05-2%; preservative: 0.21-9%; tetrahydroxypropyl ethylenediamine: 0.05-0.5%; deionized water: 26.40-90.78%. The scar cream prepared by this invention is gentle, safe, and non-irritating, with a pleasant scent, minimal heaviness, a refreshing and non-greasy feel, and a good skin texture. Furthermore, due to the combination of functional ingredients such as oat core repair factor, ascorbate tetraisopalmitate, and Centella asiatica extract, it effectively solves the problems of itching and pain caused by scars, prevents scar hyperplasia, promotes the softening and fading of scars, and lightens scar color. It also has skin-care benefits, avoids allergic reactions, and has good scar-removing effects, fast results, and a low recurrence rate.

Description

Technical Field

[0001] This invention relates to the field of scar removal drug technology, and in particular to a scar cream, its preparation method and application. Background Technology

[0002] Scar cream is a topical ointment designed to help reduce or improve various types of scars. Scars can be categorized into different types, such as hypertrophic scars, atrophic scars, flat scars, and keloid scars. Problems with existing scar cream products include: 1. The main ingredient in existing scar creams is corticosteroids. These creams have a long treatment period, certain side effects, and are prone to causing local allergic reactions, leading to symptoms such as redness, swelling, and itching, resulting in pigmentation and less than ideal scar repair effects. 2. Most existing cream-based scar creams contain medicinal ingredients, which can easily cause drug allergies, leading to poor patient compliance. Some medications can also cause local skin dryness and peeling. 3. Existing scar creams have a thick texture, poor spreadability and breathability, and feel too sticky on the skin, resulting in an unpleasant skin feel and often causing patients to discontinue use, leading to unsatisfactory scar removal results.

[0003] Therefore, there is an urgent need to develop a new type of scar cream product with a pleasant skin feel, whitening, soothing, repairing, and scar-removing functions. Summary of the Invention

[0004] In order to overcome the shortcomings of the prior art, the present invention provides a scar cream, its preparation method and application. The composition can play a role in antibacterial and anti-inflammatory, repairing wound scars, moisturizing and hydrating, and improving sebum secretion. It is a novel scar cream with good skin feel, whitening, soothing, repairing and scar removal effects.

[0005] The technical solution adopted by this invention to solve its technical problem is:

[0006] A scar cream comprising the following components in percentage by weight:

[0007] Silicone: 5-30%;

[0008] Carbomer: 0.01-0.10%;

[0009] Propylene glycol: 1-10%;

[0010] Emulsifier: 2.5-15%;

[0011] Oat kernel repair factor: 0.2-2%;

[0012] Ascorbate tetraisopalmitate: 0.2-2%;

[0013] Centella asiatica extract: 0.05-2%;

[0014] Preservatives: 0.21-9%;

[0015] Tetrahydroxypropyl ethylenediamine: 0.05-0.5%;

[0016] Deionized water: 29.40-90.78%.

[0017] Furthermore, in the components of the scar cream, the emulsifier comprises the following components in weight percentage:

[0018] Cetearyl glucoside (and) cetearyl alcohol: 1-5%;

[0019] Glyceryl stearate citrate: 0.5-5%;

[0020] Cetearyl alcohol: 1-5%;

[0021] Furthermore, in the components of the scar cream, the preservative comprises the following components in weight percentage:

[0022] Dipropylene glycol: 0.1-3%;

[0023] p-Hydroxyacetophenone: 0.1-3%;

[0024] Octyl glycol: 0.005-2%;

[0025] Ethylhexylglycerin: 0.005-1%.

[0026] Furthermore, in the components of the scar cream, the oat core repair factor has a mass percentage content of 1-2%.

[0027] Furthermore, in the components of the scar cream, the ascorbate tetraisopalmitate has a mass percentage of 1-2%.

[0028] Furthermore, in the components of the scar cream, the Centella asiatica extract has a mass percentage of 0.1-1%.

[0029] Furthermore, the ratio of oat core repair factor: ascorbate tetraisopalmitate: centella asiatica extract is 5:5:1.

[0030] Another object of the present invention is to provide a method for preparing a scar cream, wherein the steps are as follows:

[0031] S1. Sprinkle carbomer powder onto an appropriate amount of deionized water to fully wet and disperse it, and set aside.

[0032] S2. Add the remaining deionized water to the aqueous phase pot and heat to 75-80℃;

[0033] S3. Add the carbomer aqueous solution that has been dispersed and prepared in step S1 into the aqueous phase pot, stir and homogenize until the product is homogeneous.

[0034] S4. Add silicone, cetearyl glucoside (and) cetearyl alcohol, glyceryl stearate citrate, cetearyl alcohol, oat core repair factor, and ascorbate tetraisopalmitate to the reaction vessel in sequence, heat to 75-80℃, so that all the solids are melted and the product is in a homogeneous state, and keep warm for 15-20 minutes.

[0035] S5. Transfer the liquid from the aqueous phase vessel to the reaction vessel, stir to homogenize and emulsify, then vacuum and cool.

[0036] S6. Add Centella asiatica extract powder to propylene glycol and disperse for later use;

[0037] S7. After the temperature of the reactor drops below 45°C, add step S6, p-hydroxyacetophenone, octyl glycol, and ethylhexylglycerin to the reactor in sequence and stir until homogeneous.

[0038] S8. Finally, add tetrahydroxypropylethylenediamine to the reaction vessel and stir. Test the pH value and viscosity of the product until they reach the specified range.

[0039] Furthermore, in step S8, the pH is 5.0 to 6.5, and the viscosity is 80,000 mPa·s to 120,000 mPa·s.

[0040] The third objective of this invention is to provide an application of scar cream in skin scar removal.

[0041] The scar cream provided by this invention has at least the following beneficial effects:

[0042] 1. This invention does not add preservatives from the traditional preservative list, but instead selects a compound of polyols such as dipropylene glycol, caprylyl glycol, and ethylhexylglycerin with p-hydroxyacetophenone. The low amount added can achieve the effect of preservation, and it is mild, safe and non-irritating.

[0043] 2. This invention selects silicone elastomer silicone oil and a reasonable emulsifier to effectively solve the problem of thick ointment, with a pleasant odor, less heaviness, refreshing and non-greasy feel, and good skin feel.

[0044] 3. This invention selects a compound of functional raw materials, including oat core repair factor, ascorbate tetraisopalmitate, and centella asiatica extract, which can effectively solve the problems of itching and pain caused by scars, prevent scar hyperplasia, promote the softening and fading of scars, lighten the color of scars, and at the same time have skin care effects and avoid the occurrence of allergic reactions.

[0045] 4. It has a good scar removal effect, works quickly, and has a low recurrence rate. Attached Figure Description

[0046] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0047] Figure 1 This is a flowchart illustrating the preparation process of a scar cream according to the present invention;

[0048] Figure 2 This is a distribution diagram of animal test sites in the skin irritation test of this invention;

[0049] Figure 3 This is a photo of the original scar from clinical test case 1;

[0050] Figure 4 These are photos of scars treated with the scar cream of this invention for 3 months after clinical trial case 1;

[0051] Figure 5 This is a photo of the original scar from clinical test case 2;

[0052] Figure 6 This is a photo of the scar after 3 months of treatment with the scar cream of this invention in clinical trial case 2. Detailed Implementation

[0053] In this application, all commonly used chemical reagents used in the embodiments are commercially available products that can be purchased through conventional channels.

[0054] This invention provides a scar cream, its preparation method, and its application. The composition can play a role in antibacterial and anti-inflammatory, repairing wound scars, moisturizing, and improving sebum secretion. It is a novel scar cream with good skin feel, whitening, soothing, repairing, and scar-removing effects.

[0055] The preparation method and process flow of this scar cream are as follows: Figure 1 As shown, it includes the following steps:

[0056] S1. Sprinkle carbomer powder onto an appropriate amount of deionized water to fully wet and disperse it, and set aside.

[0057] S2. Add the remaining deionized water to the aqueous phase pot and heat to 75-80℃;

[0058] S3. Add the carbomer aqueous solution that has been dispersed and prepared in step S1 to the aqueous phase pot, stir and homogenize until the product is homogeneous.

[0059] S4. Add silicone, cetearyl glucoside (and) cetearyl alcohol, glyceryl stearate citrate, cetearyl alcohol, oat core repair factor, and ascorbate tetraisopalmitate to the reaction vessel in sequence, heat to 75-80℃ to melt all the solids until the product is homogeneous, and then keep warm for 15-20 minutes.

[0060] S5. Transfer the liquid from the aqueous phase vessel to the reaction vessel, stir to homogenize and emulsify, then vacuum and cool.

[0061] S6. Add Centella asiatica extract powder to propylene glycol and disperse for later use;

[0062] S7. After the temperature of the reactor drops below 45°C, add the material from step S6, p-hydroxyacetophenone, octyl glycol, and ethylhexylglycerin to the reactor in sequence and stir until homogeneous.

[0063] S8. Finally, add tetrahydroxypropylethylenediamine to the reaction vessel and stir. Test the pH value and viscosity of the product until they reach the specified range.

[0064] In the above steps, the p-hydroxyacetophenone used is a natural plant extract, naturally found in the stems and leaves of *Artemisia capillaris*, roots of *Artemisia capillaris*, *Asclepiadaceae* plants, and *Gynostemma pentaphyllum*. It possesses antioxidant and soothing properties and is a mild, additive-free, and non-irritating preservative accelerator. Its antioxidant and antibacterial properties derive from its hydroxyl groups, exhibiting excellent stability across high and low pH and temperature ranges. It can extend the shelf life of other active ingredients under high-temperature conditions and enhance the efficacy of various preservatives. When used alone, p-hydroxyacetophenone requires an addition of 1% to achieve a relatively good antibacterial effect, but its antifungal ability is weak. Higher addition levels result in poor water solubility, potential precipitation at low temperatures, and may affect skin feel. Therefore, it needs to be formulated with other preservatives and polyols.

[0065] Dipropylene glycol, a polyol, is a high-purity, colorless, odorless, water-soluble, and hygroscopic liquid. It is an ideal solvent, readily dissolving p-hydroxyacetophenone, exhibiting excellent co-solubility for water, oils, and hydrocarbons. Furthermore, it has a mild odor, minimal skin irritation, and very low toxicity.

[0066] Caprylyl glycol is a good humectant that provides moisturizing and softening effects to the skin. It also has antibacterial properties, reducing water activity and interfering with cell membrane activity. It can penetrate the cell membranes of microorganisms, disrupting their integrity and causing cell fluid to leak out, leading to cell dehydration and death. When used alone, a concentration of 5% is needed to achieve a certain inhibitory effect on yeast and Gram-negative bacteria, but it is less effective against molds and Gram-positive bacteria. Higher concentrations can easily cause skin irritation, burning sensations, and an unpleasant skin feel.

[0067] Ethylhexylglycerol is a glycerol ether with a surfactant-like structure. It can alter the interfacial tension of microbial cell membranes, disrupting their integrity and allowing preservatives to penetrate more effectively into microbial cells. This interferes with microbial growth and metabolism, thereby inhibiting microbial growth. However, high concentrations can easily cause skin irritation and burning, resulting in a poor skin feel.

[0068] The preservatives of this invention are a combination of dipropylene glycol, p-hydroxyacetophenone, octyl glycol, and ethylhexylglycerin. The preservative effect can be achieved with a relatively low dosage, and the system is milder, safer, and non-irritating.

[0069] This invention selects silicone elastomer silicone oil and combines it with emulsifiers, which can effectively solve the problem of thick ointments, and has a pleasant odor, less heaviness, refreshing and non-greasy feel, and good skin feel.

[0070] The Centella asiatica extract of this invention is derived from Centella asiatica, specifically the dried whole herb of the perennial creeping herbaceous plant Centella asiatica (Apiaceae family). The main active components of the Centella asiatica extract are asiatic acid and hydroxyasiatic acid, asiaticoside, and hydroxyasiaticoside. The extract contains asiatic acid and hydroxyasiatic acid; these active saponins acidify the cytoplasm in plant cells. The extract possesses antibacterial and anti-inflammatory activities, reducing the production of pro-inflammatory mediators (MMP-1), enhancing and repairing the skin's barrier function, thereby preventing and correcting skin immune dysfunction. Furthermore, the extract has strong antioxidant properties, inhibiting free radical activity, improving blood circulation, regenerating skin cells, and helping melanin to be metabolized and excreted, thus lightening melanin deposition. After use, the skin is smooth, delicate, and radiant. The Centella asiatica extract can promote the synthesis of proteins (such as collagen and fibronectin) in the skin, increase the skin protein content, promote the healing of minor skin wounds, and help repair sunburned skin. Centella asiatica extract can affect the ultrastructure of fibroblasts, making their proliferation less active and inhibiting scar hyperplasia. This invention uses wild Centella asiatica from the Madagascar highlands, and through refining asiaticoside and aglycones, extracts a asiaticoside-hydroxyasiatic acid-asiatic acid composition with a purity greater than 95%.

[0071] The oat core repair factor of this invention is a non-greasy, "dry" oil with a clear golden color and a mild natural aroma. It contains unique antioxidants, including ferulic acid and caffeic acid, which prevent lipid peroxidation in the skin. It is easily absorbed by the skin, moisturizing and nourishing it, improving the skin barrier, and supporting the skin's physiological functions: protection, softening, soothing, and repair. The oat core repair factor used in this invention is sourced from Sweden, with a total polar lipid content greater than 10% and a ceramide content greater than 1.5%, and is an ECOCERT-certified natural ingredient.

[0072] The ascorbate tetraisopalmitate of this invention, abbreviated as VC-IP (Vitamin Ctetraisopalmitate), is a hydroxylated form of vitamin C. Its molecule contains four palmitic acid groups and is a fat-soluble derivative. Compared to water-soluble vitamin C, it can penetrate the dermis and is more easily absorbed by the body. VC-IP can be effectively converted into vitamin C and exert its effects after entering cells. It can reduce the production of cell proliferation factors IL-1X and PGE2 by keratinocytes, thereby inhibiting tyrosinase activity, lightening existing melanin, inhibiting UVB, reducing skin pigmentation caused by ROS (reactive oxygen species) damage, promoting collagen synthesis in fibroblasts, promoting wound healing, and repairing damaged skin. The ascorbate tetraisopalmitate used in this invention has a content greater than 95% and is derived from the modification of the vitamin C molecular structure using bio-enzyme technology.

[0073] The combination of Centella asiatica extract, oat core repair factor, and tetraisopalmitate ascorbate effectively addresses itching and pain caused by scars, prevents scar hyperplasia, softens and flattens scars, and lightens scar color. It also whitens, soothes, and repairs the skin, providing skincare benefits and preventing allergic reactions. Preferably, the scar cream prepared by combining Centella asiatica extract, oat core repair factor, and tetraisopalmitate in a 5:5:1 ratio exhibits superior scar-fading and skin-whitening effects.

[0074] In addition, to facilitate understanding by those skilled in the art, the present invention will be further described below with reference to embodiments. The content mentioned in the embodiments is not intended to limit the invention.

[0075] Examples 1-13 were prepared according to the following component percentages by mass:

[0076] Example 1:

[0077] The scar cream contains the following ingredients by weight percentage:

[0078] Carbomer 0.05%;

[0079] Propylene glycol 8.00%;

[0080] Silicone 25.00%;

[0081] Cetearyl glucoside (and) cetearyl alcohol 3.00%;

[0082] Glyceryl stearate citrate 2.00%;

[0083] Cetearyl alcohol 2.50%;

[0084] Oat core repair factor 1.00%;

[0085] Ascorbate tetraisopalmitate 1.00%;

[0086] Centella asiatica extract 0.20%;

[0087] Dipropylene glycol 1.00%;

[0088] p-Hydroxyacetophenone 1.00%;

[0089] Octyl glycol 0;

[0090] Ethylhexylglycerin 0;

[0091] 0.14% tetrahydroxypropyl ethylenediamine;

[0092] The remainder is deionized water.

[0093] The preparation steps of the scar cream in this embodiment are as follows:

[0094] S1. Sprinkle carbomer powder onto 10 parts of deionized water, allowing it to fully wet and disperse, and set aside;

[0095] S2. Add the remaining deionized water to the aqueous phase pot and heat to 75°C;

[0096] S3. Add the carbomer aqueous solution that has been dispersed and prepared in step S1 to the aqueous phase pot, stir and homogenize until the product is homogeneous.

[0097] S4. Add silicone, cetearyl glucoside (and) cetearyl alcohol, glyceryl stearate citrate, cetearyl alcohol, oat core repair factor, and ascorbate tetraisopalmitate to the reaction vessel in sequence, heat to 75°C to melt all the solids until the product is homogeneous, and then keep warm for 15 minutes.

[0098] S5. Transfer the liquid from the aqueous phase vessel to the reaction vessel, stir to homogenize and emulsify, then vacuum and cool.

[0099] S6. Add Centella asiatica extract powder to propylene glycol and disperse for later use;

[0100] S7. After the temperature of the reactor drops below 45°C, add the material from step S6, p-hydroxyacetophenone, octyl glycol, and ethylhexylglycerin to the reactor in sequence and stir until homogeneous.

[0101] S8. Finally, add tetrahydroxypropylethylenediamine to the reaction vessel and stir. Test the pH value of the product to be 5.0 and the viscosity to be 80000 mPa·s to obtain scar cream-1.

[0102] Example 2:

[0103] Compared with Example 1, the scar cream of this embodiment has p-hydroxyacetophenone removed and caprylyl glycol added. The weight percentage of caprylyl glycol is 2.00%, and the weight percentage of deionized water is adjusted accordingly. The rest are the same.

[0104] The preparation steps of the scar cream in this embodiment are as follows:

[0105] S1. Sprinkle carbomer powder onto 10 parts of deionized water, allowing it to fully wet and disperse, and set aside;

[0106] S2. Add the remaining deionized water to the aqueous phase pot and heat to 80°C;

[0107] S3. Add the carbomer aqueous solution that has been dispersed and prepared in step S1 to the aqueous phase pot, stir and homogenize until the product is homogeneous.

[0108] S4. Add silicone, cetearyl glucoside (and) cetearyl alcohol, glyceryl stearate citrate, cetearyl alcohol, oat core repair factor, and ascorbate tetraisopalmitate to the reaction vessel in sequence, heat to 80°C to melt all the solids until the product is homogeneous, and then keep warm for 20 minutes.

[0109] S5. Transfer the liquid from the aqueous phase vessel to the reaction vessel, stir to homogenize and emulsify, then vacuum and cool.

[0110] S6. Add Centella asiatica extract powder to propylene glycol and disperse for later use;

[0111] S7. After the temperature of the reactor drops below 45°C, add the material from step S6, p-hydroxyacetophenone, octyl glycol, and ethylhexylglycerin to the reactor in sequence and stir until homogeneous.

[0112] S8. Finally, add tetrahydroxypropyl ethylenediamine to the reaction vessel and stir. Test the pH value of the product to be 6.5 and the viscosity to be 120000 mPa·s to obtain scar cream-2.

[0113] Example 3:

[0114] Compared with Example 1, the scar cream of this embodiment has the following changes: p-hydroxyacetophenone has been removed and ethylhexylglycerin has been added. The weight percentage of ethylhexylglycerin is 0.15%, and the weight percentage of deionized water has been adjusted accordingly. The rest are the same.

[0115] The preparation steps of the scar cream in this embodiment are the same as those in Example 1, and scar cream-3 is obtained.

[0116] Example 4:

[0117] Compared with Example 1, the raw materials of the scar cream in this embodiment have the following differences: the weight percentage of p-hydroxyacetophenone is reduced to 0.15%, caprylyl glycol is added at a weight percentage of 0.07%, ethylhexylglycerin is added at a weight percentage of 0.05%, and the weight percentage of deionized water is adjusted accordingly; the rest are the same.

[0118] The preparation steps of the scar cream in this embodiment are the same as those in Example 1, and scar cream-4 is obtained.

[0119] Example 5:

[0120] Compared with Example 4, the raw materials of the scar cream in this embodiment have the following changes: the weight percentage of p-hydroxyacetophenone is increased to 0.30%, the weight percentage of caprylyl glycol is increased to 0.14%, the weight percentage of ethylhexylglycerin is increased to 0.10%, and the weight percentage of deionized water is adjusted accordingly; the rest are the same.

[0121] The preparation steps of the scar cream in this embodiment are the same as in Example 2, and scar cream-5 is obtained.

[0122] Example 6:

[0123] The scar cream contains the following ingredients by weight percentage:

[0124] Carbomer 0.01%;

[0125] Propylene glycol 1.00%;

[0126] Silicone 5.00%;

[0127] Cetearyl glucoside (and) cetearyl alcohol 1.00%;

[0128] Glyceryl stearate citrate 0.50%;

[0129] Cetearyl alcohol 1.00%;

[0130] Oat core repair factor 0.20%;

[0131] Ascorbate tetraisopalmitate 0.2%;

[0132] Centella asiatica extract 0.05%;

[0133] Dipropylene glycol 0.10%;

[0134] p-Hydroxyacetophenone 0.10%;

[0135] Octyl glycol 0.005%;

[0136] Ethylhexylglycerin 0.005%;

[0137] 0.05% tetrahydroxypropyl ethylenediamine;

[0138] The remainder is deionized water.

[0139] The preparation steps of the scar cream in this embodiment are the same as those in Example 1, and scar cream-6 is obtained.

[0140] Example 7:

[0141] The scar cream contains the following ingredients by weight percentage:

[0142] Carbomer 0.10%;

[0143] Propylene glycol 10.00%;

[0144] Silicone 30.00%;

[0145] Cetearyl glucoside (and) cetearyl alcohol 5.00%;

[0146] Glyceryl stearate citrate 5.00%;

[0147] Cetearyl alcohol 5.00%;

[0148] Oat core repair factor 2.00%;

[0149] Ascorbate tetraisopalmitate 2.00%;

[0150] Centella asiatica extract 2.00%;

[0151] Dipropylene glycol 3.00%;

[0152] p-Hydroxyacetophenone 3.00%;

[0153] Octyl glycol 2.00%;

[0154] Ethylhexylglycerin 1.00%;

[0155] 0.50% tetrahydroxypropyl ethylenediamine;

[0156] The remainder is deionized water.

[0157] The preparation steps of the scar cream in this embodiment are the same as those in Example 1, and scar cream-7 is obtained.

[0158] Example 8:

[0159] Compared with Example 5, the raw materials of the scar cream in this embodiment have been modified by removing ascorbic acid tetraisopalmitic acid and Centella asiatica extract, and the weight percentage of deionized water has been adjusted accordingly, while the rest are the same.

[0160] The preparation steps of the scar cream in this embodiment are the same as those in Example 1, and scar cream-8 is obtained.

[0161] Example 9:

[0162] Compared with Example 5, the raw materials of the scar cream in this embodiment have been modified by removing oat core repair factor and centella asiatica extract, and the weight percentage of deionized water has been adjusted accordingly, while the rest are the same.

[0163] The preparation steps of the scar cream in this embodiment are the same as those in Example 1, and scar cream-9 is obtained.

[0164] Example 10:

[0165] Compared with Example 5, the raw materials of the scar cream in this embodiment have been modified by removing oat core repair factor and ascorbic acid tetraisopalmitic acid, and the weight percentage of deionized water has been adjusted accordingly, while the rest are the same.

[0166] The preparation steps of the scar cream in this embodiment are the same as those in Example 1, and scar cream-10 is obtained.

[0167] Example 11:

[0168] Compared with Example 5, the raw materials of the scar cream in this embodiment have been modified by removing oat core repair factor, ascorbic acid tetraisopalmitic acid and centella asiatica extract, and the weight percentage of deionized water has been adjusted accordingly, while the rest are the same.

[0169] The preparation steps of the scar cream in this embodiment are the same as those in Example 1, and scar cream-11 is obtained.

[0170] Example 12:

[0171] Compared with Example 5, the raw materials of the scar cream in this embodiment have the following differences: the weight percentage of oat core repair factor is reduced to 0.50%, the weight percentage of ascorbic acid tetraisopalmitic acid is reduced to 0.50%, and the weight percentage of Centella asiatica extract is reduced to 0.10%. The weight percentage of deionized water is adaptively adjusted, while the rest remain the same.

[0172] The preparation steps of the scar cream in this embodiment are the same as those in Example 1, and scar cream-12 is obtained.

[0173] Example 13:

[0174] Compared with Example 12, the raw materials of the scar cream in this embodiment have the following changes: the weight percentage of oat core repair factor is increased to 1.00%, the weight percentage of ascorbic acid tetraisopalmitic acid is increased to 1.00%, and the weight percentage of Centella asiatica extract is increased to 0.20%. The weight percentage of deionized water is adaptively adjusted, and the rest are the same.

[0175] The preparation steps of the scar cream in this embodiment are the same as those in Example 1, and scar cream-13 is obtained.

[0176] The preservative properties of the scar cream products prepared in Examples 1-7 were tested:

[0177] Test method: Refer to United States Pharmacopeia (USP) 42(51).

[0178] The selected test strains include bacteria and fungi, specifically:

[0179] Bacteria: Pseudomonas aeruginosa (ATCC No. 9027), Escherichia coli (ATCC No. 8739), Staphylococcus aureus (ATCC No. 6538);

[0180] Fungi: Candida albicans (ATCC No. 10231, Aspergillus niger (ATCC No. 16404)).

[0181] Evaluation criteria:

[0182] Bacteria: The decrease in the logarithm of the bacterial count at 14 days compared to the initial bacterial count must not be less than 2.0, and the bacterial count at 28 days must not be greater than that at 14 days;

[0183] Fungi: The number of fungi cannot increase from the initial stage to 14 days and 28 days.

[0184] The test data is as follows:

[0185] Table 1 - Bacteria:

[0186]

[0187] Table 2 - Fungi:

[0188]

[0189] Experimental results:

[0190] Analysis of experimental data shows that p-hydroxyacetophenone, octyl glycol, and ethylhexylglycerin, used alone, have certain preservative effects. However, their combined use achieves a synergistic effect. In the experiment, a smaller dosage was sufficient to achieve better preservative efficacy. This addition ratio makes the system mild, safe, and non-irritating, and prevents contamination during repeated use after opening, ensuring product safety and effectively extending the product's shelf life.

[0191] Skin irritation tests were conducted on the scar cream product prepared in Example 5:

[0192] Test method: Refer to GB / T 16886.7-2017 Biological evaluation of medical devices - Part 10: Irritation and skin sensitization test.

[0193] Preparation of extract: Take 5g of sample + 25ml of polar extract physiological saline or non-polar extract soybean oil and extract at (50±2)℃ for (72±2)h. Shake continuously during the extraction process.

[0194] In this experiment, healthy New Zealand rabbits were selected. The samples from Case 5, along with commercially available scar creams A and B, were prepared using polar extracts, saline, non-polar extracts, soybean oil, and a control agent. These were applied topically to the test animals for 4 hours. The local skin irritation response of the animals was then observed and evaluated at 1 hour, 24 hours, 48 ​​hours, and 72 hours.

[0195] Test steps:

[0196] 24 hours before the experiment, the hair on both sides of the spine on the back of the animal was removed (approximately 10cm x 15cm) to serve as the experimental and observation site.

[0197] On the day of the experiment, four sites were identified on each animal: the sides of the head and tail on both sides of the back, as referenced. Figure 1 As shown, 1. Head; 2. Test site; 3. Control site; 4. Shoulder and back; 5. Tail.

[0198] These areas were free of defects that could affect the interpretation of the results. 0.5 mL of each of the sample and control extracts were dropped onto a 2.5 cm x 25 cm absorbent patch, which was then applied to the skin on both sides of the rabbit's spine and secured with medical tape for 4 hours. After the contact period, the patch was removed, the contact site was marked with durable ink, and any remaining experimental material was washed away with warm water.

[0199] Experimental observation:

[0200] 1. Observe the animals' health status daily;

[0201] 2. Record the weight of each animal before processing;

[0202] 3. According to the standards in the table below, record the skin erythema and edema at 1 hour, 24 hours, 48 ​​hours and 72 hours after removing the patch.

[0203] Table 3 - Scoring criteria for skin irritation response and types of rabbit irritation response include:

[0204]

[0205] Table 4 - Rabbit Stimulation Response Types

[0206]

[0207]

[0208] Results evaluation criteria:

[0209] Calculations were performed using observation data from 24 hours, 48 ​​hours, and 72 hours.

[0210] The sum of the erythema and edema stimulation scores for each animal at the specified time is divided by the total number of observations (6, 2 test sites x 3 observation times) to obtain the primary stimulation score for each animal (Note: the positive control is tested once every 3 months, each rabbit uses only one test site, and the total number of observations is 3).

[0211] The average score of the primary stimulus in the three experimental animals is the primary stimulus index.

[0212] Calculate the primary stimulus score for the control group, and subtract this score from the primary stimulus score for the test sample to obtain the primary stimulus score. This value is the primary stimulus index of the test sample. Determine the stimulus response type of the test sample according to the table below.

[0213] Table 5 shows the skin response scores of rabbits as follows:

[0214]

[0215] Experimental results:

[0216] Analysis showed that the primary irritation index was 0 in both the polar and non-polar control groups. No redness or swelling was observed in rabbit skin from the extract in Case 5; the rabbit irritation response types for both the polar and non-polar extracts in Case 5 were very mild. The extract of commercially available scar cream A caused the rabbit skin to turn bright red, with a 1.2 mm elevation and moderate edema. The rabbit irritation response types for both the polar and non-polar extracts were moderate. The extract of commercially available scar cream B caused the rabbit skin to turn bright red with significant edema; the rabbit irritation response types for both the polar and non-polar extracts were mild.

[0217] The whitening efficacy of the scar cream products prepared in Examples 5-13 was evaluated.

[0218] Test Method: Tyrosinase was selected as the detection indicator. Melanin in the skin uses tyrosinase as a substrate. Tyrosinase is a key enzyme that acts on dopa to form dopaquinone, which then spontaneously undergoes a series of reactions to finally form melanin. In a phosphate solution at pH 6.8, tyrosinase can catalyze the conversion of dopa to dopaquinone, and the absorbance can be measured at 475 nm using a spectrophotometer. Materials with tyrosinase activity inhibitory effects can reduce the conversion of dopa to dopaquinone, thus achieving a lightening effect on scar pigmentation. This experiment used tyrosinase activity as the detection tool, and designed negative controls, positive controls, and sample groups, with three biological replicates for each group. The sample was reacted with tyrosinase and the substrate, and the absorbance was measured at 475 nm. The inhibitory effect of the sample on tyrosinase activity was evaluated based on the changes in absorbance. Negative control: No sample or kojic acid added. Positive control: Kojic acid (purity greater than 98.5%). Kojic acid is a commonly used positive control in tyrosinase activity inhibition assays. It is one of the tyrosinase inhibitors and can effectively prevent the activation of tyrosinase and interfere with melanin synthesis.

[0219] Evaluation criteria: The whitening effect of the sample is evaluated by calculating the inhibition rate of tyrosinase activity. The higher the inhibition rate, the better the effect on lightening the color of the scar and the better the whitening effect.

[0220] Table 6 - Inhibition rate of tyrosinase activity in Examples 5-13 and the control group

[0221]

[0222]

[0223] Experimental results: The inhibition rate of tyrosinase in cases 5-7 and 12-13 was better than that in case 8-11, indicating that the combination of the three functional additives played a synergistic role and had a better effect on scar color fading and whitening compared with the single functional additive.

[0224] The scar cream products prepared in Examples 5-13 were tested for their repair efficacy.

[0225] Experimental principle:

[0226] Zebrafish caudal fin regeneration involves three processes: wound healing, bud formation, and regeneration outcome, with bud formation being the most crucial. Cells involved in fin regeneration originate from multiple sources, including epidermal cells, fibroblasts, and osteoblasts, all of which promote caudal fin regeneration and exhibit high lineage restriction. The regeneration mechanism of zebrafish caudal fins is similar to that of human skin, bone, and blood vessels. Due to its simple structure, ease of surgical manipulation, lack of postoperative impact on survival, and ease of observation, the zebrafish caudal fin has become an important model for studying tissue regeneration. The regenerative efficacy of the samples was evaluated by quantifying the area of ​​the regenerated caudal fin after surgically cutting it perpendicular to the trunk. Statistical analysis showed p < 0.05 as a significant difference.

[0227] Test method:

[0228] Wild-type AB strain zebrafish were selected, with the zebrafish aged 3 days after fertilization.

[0229] A zebrafish tail fin injury model was established by surgically removing the zebrafish tail fin.

[0230] Transfer the model zebrafish to a 6-well plate, 15 fish per well.

[0231] The sample was administered in water, and a normal control group and a model control group were set up, with a volume of 3 ml per well.

[0232] Incubate at 28℃ in the dark for 48 hours.

[0233] Ten zebrafish were randomly selected from each experimental group and photographed under a dissecting microscope. Advanced image processing software was used to analyze and collect data, and the caudal fin area (A) of the zebrafish was analyzed. The repair efficacy of the samples was calculated according to the formula.

[0234] The normal control group received no treatment. Both the model control group and the sample group underwent surgical removal of the tail fin to create the model. The sample group was treated with scar cream prepared according to the corresponding embodiment at the same concentration.

[0235] Evaluation criteria: The wound healing rate is judged by the increase in the area of ​​the zebrafish's tail fin through statistical analysis. The greater the increase in area, the better the skin repair effect.

[0236]

[0237] Table 7 - Results of the scar cream products prepared in Examples 6-13: Repairing efficacy test results

[0238] normal control group 100.0 —— —— Model control group 0.0 —— —— Implementation Case 6 60.61 <0.01 Significant Implementation Case 7 96.97 <0.001 Extremely significant Implementation Case 8 47.47 <0.01 Significant Implementation Case 9 58.59 <0.01 Significant Implementation Case 10 56.57 <0.01 Significant Implementation Case 11 19.19 <0.05 There is a statistical difference Implementation Case 12 74.75 <0.001 Extremely significant Implementation Case 13 92.93 <0.001 Extremely significant

[0239] Experimental Results: The test results show that after the caudal fins of zebrafish were removed, the healing rate of the caudal fin wounds in cases 6-7 and 12-13 was better than that in case 8-11 after 48 hours of contact. This indicates that the compound of this functional additive played a synergistic role, promoting the repair of damaged cells, and its effect was better than that of a single functional additive.

[0240] Sensory experience tests were conducted on the scar cream products prepared in Examples 6-13:

[0241] Test method: Purchase three commercially available scar creams A, B, and C, along with Case 6-13, for sensory experience; randomly select 50 volunteers, take 2g of the cream on the volunteer's wrist, gently spread it with the index finger, apply it evenly, and evaluate it comprehensively based on its spreadability, thickness, and smell.

[0242] Evaluation criteria:

[0243] Extensibility assessment: A. Easy to apply and evenly; B. Difficult to apply and subject to resistance; C. Difficult to apply and unevenly applied.

[0244] Weight assessment: A. Lightweight and breathable, refreshing; B. Relatively heavy, poor breathability, sticky feeling; C. Heavy and stuffy, strong stickiness.

[0245] Odor assessment: A. Pleasant odor, very likable; B. Unpleasant odor, but acceptable; C. Pungent odor, unpleasant smell, unacceptable.

[0246] Table 8 - Sensory experience test results of the scar cream products prepared in Examples 6-13

[0247]

[0248] Clinical evaluation tests were conducted on the scar cream product prepared in Example 13:

[0249] Treatment Method: Fifty subjects (22 males, 28 females, aged 20-45 years, evaluation age 33.6 years) with hypertrophic scars after burns, trauma, or ulcers, treated at a hospital in Wuhan from June 2021 to August 2022, were selected for a hypertrophic scar repair experiment. The hypertrophic scars had a duration of 1-10 months, and all had formed hypertrophic scars with a reddish color, pigmentation, and a hard texture. The subjects were randomly divided into two groups of 25 each, with no statistically significant difference between the two groups. The scar cream of this invention (Example 11) and a commercially available scar cream were used for treatment and repair, respectively, twice daily, once in the morning and once in the evening, for 6 consecutive months.

[0250] All participants in the clinical validation were admitted on a voluntary basis. They were fully informed of the purpose, process, and duration of the clinical validation, the role and benefits of using the validation device in clinical practice, the potential risks of device use, and the measures to be taken. All participants signed informed consent forms.

[0251] Evaluation criteria:

[0252] Scar color: The color is assessed by comparing the degree of pigmentation of the scar with that of the surrounding normal skin. A significant difference is scored as 3 points, a slight difference as 2 points, and no difference as 1 point.

[0253] Blood vessel distribution: Purple or dark red, rich blood supply, 4 points; red, significantly increased local blood supply, 3 points; pink, slightly increased local blood supply, 2 points; color similar to normal body parts, 1 point.

[0254] Scar thickness: The thickness of the scar is measured using ultrasound. A thickness greater than 4 mm is scored as 5 points; a thickness between 3 and 4 mm is scored as 4 points; a thickness between 1 and 3 mm is scored as 3 points; a thickness less than 1 mm is scored as 2 points; and a flat or depressed scar is scored as 1 point.

[0255] Scar hardness: Contracture, permanent shortening of the scar, causing disability and distortion, is scored as 5 points; Curved, with tissue resembling a snake, the scar stretches and retracts, is scored as 4 points; Hard scar, cannot be deformed when pressed, moves in a blocky shape, and encounters resistance, is scored as 3 points; Soft scar, can be deformed by hand, is scored as 2 points; Soft scar, can be deformed by light pressure, is scored as 1 point; Normal, is scored as 0 points.

[0256] Pain: Severe pain that is unbearable is scored as 5 points; moderate pain that is still bearable is scored as 4 points; mild pain is scored as 3 points; occasional pain is scored as 2 points; no pain is scored as 1 point.

[0257] Itching: Severe itching that is unbearable is scored as 5 points; moderate itching that is still bearable is scored as 4 points; mild itching is scored as 3 points; occasional itching is scored as 2 points; no itching is scored as 1 point.

[0258] The clinical efficacy of the treatment was evaluated in two groups of participants after 3 months and 6 months, based on factors such as scar color, blood vessel distribution, scar thickness, scar hardness, pain and itching experienced by the participants. The sum of the scores for each of the above indicators was the total score for scar severity, with a higher score indicating a more severe scar.

[0259] Efficacy evaluation criteria: Scar efficacy index = (total scar score before treatment - total scar score after treatment) / total scar score before treatment × 100%. The evaluation is based on four criteria: basic cure, significant effect, effective, and ineffective.

[0260] Basic cure: efficacy ≥ 80%; Significant effect: efficacy index 60-80%; Effective: efficacy index 30-60%; Ineffective: efficacy index ≤ 30%.

[0261] Overall effective rate = (Number of cases basically cured + Number of cases showing significant improvement + Number of cases showing improvement) / Total number of cases × 100%

[0262] Clinical results:

[0263] Comparison of clinical efficacy between the two groups of patients:

[0264] After 3 months of treatment, in the experimental group, 3 patients were basically cured, 7 showed significant improvement, and 8 showed improvement, with a total effective rate of 72.0%, significantly better than the control group (1 basically cured, 5 showing significant improvement, 7 showing improvement, total effective rate 52.0%). The difference between the two groups was statistically significant (P < 0.01). After 6 months of treatment, in the experimental group, 5 patients were basically cured, 10 showed significant improvement, and 9 showed improvement, with a total effective rate of 96.0%, significantly better than the control group (3 basically cured, 9 showing significant improvement, 8 showing improvement, total effective rate 52.0%). The difference between the two groups was statistically significant (P < 0.01). In conclusion, after both 3 and 6 months of treatment, the clinical efficacy of the patients in the study group was significantly better than that in the control group.

[0265] The experimental group consisted of 25 patients with hypertrophic scars. No adverse events occurred during the treatment, indicating that the product has a high level of safety.

[0266] Table 9 - Comparison of clinical efficacy between the two groups of patients

[0267]

[0268] Typical Case 1:

[0269] Ms. Chen, female, 40 years old, accidentally burned her arm while cooking, resulting in pigmentation, noticeable redness, and frequent, severe itching. After using this product for 3 months, as... Figure 3 , 4 As shown, the scars have significantly improved, the pigmentation has faded, the redness has subsided, and there is no itching.

[0270] Typical Case 2:

[0271] Ms. Liu, female, 30 years old, accidentally scratched her elbow with a sharp object, leaving a hard scar that does not deform when pressed. After using this product for 3 months, if... Figure 5 , 6 As shown, the scars have disappeared, and there is no difference in pigmentation between the scar area and the surrounding normal skin. The scar removal effect is good, fast, and there is no recurrence.

[0272] The above embodiments are preferred implementations of the present invention. In addition, the present invention can be implemented in other ways. Any obvious substitutions without departing from the concept of the present invention are within the protection scope of the present invention.

Claims

1. A scar cream, characterized in that, Composed of the following components by mass percentage composition: Silicone: 5-30%; Carbomer: 0.01-0.10%; Propylene glycol: 1-10%; Emulsifier: 2.5-15%; Oat core repair factor: 0.2-2%; Ascorbate tetraisopalmitate: 0.2-2%; Centella asiatica extract: 0.05-2%; Preservatives: 0.21-9%; Tetrahydroxypropyl ethylenediamine: 0.05-0.5%; Deionized water: 29.40-90.78%; In the components of the scar cream, the emulsifier comprises the following components in weight percentage: Cetearyl glucoside and cetearyl alcohol: 1-5%; Glyceryl stearate citrate: 0.5-5%; Cetearyl alcohol: 1-5%; The preservative is composed of the following components in weight percentage: Dipropylene glycol: 0.1-3%; p-Hydroxyacetophenone: 0.1-3%; Octyl glycol: 0.005-2%; Ethylhexylglycerin: 0.005-1%; The ratio of oat core repair factor, ascorbate tetraisopalmitate, and centella asiatica extract is 5:5:

1.

2. The scar cream of claim 1, wherein, In the components of the scar cream, the oat core repair factor has a mass percentage of 1-2%.

3. The scar cream according to claim 1, characterized in that, In the components of the scar cream, the ascorbic acid tetraisopalmitate has a mass percentage of 1-2%.

4. The scar cream according to claim 1, characterized in that, In the components of the scar cream, the Centella asiatica extract has a mass percentage of 0.1-1%.

5. A method for preparing a scar cream, used to prepare the scar cream according to any one of claims 1-4, characterized in that, S1. Sprinkle carbomer powder onto an appropriate amount of deionized water to fully wet and disperse it, and set aside. S2. Add the remaining deionized water to the aqueous phase pot and heat to 75-80℃; S3. Add the carbomer aqueous solution that has been dispersed and prepared in step S1 into the aqueous phase pot, stir and homogenize until the product is homogeneous. S4. Add silicone, cetearyl glucoside and cetearyl alcohol, glyceryl stearate citrate, cetearyl alcohol, oat core repair factor and ascorbate tetraisopalmitate to the reaction vessel in sequence, heat to 75-80℃, so that all solids are melted and the product is in a homogeneous state, and keep warm for 15-20 min. S5. Transfer the liquid from the aqueous phase vessel to the reaction vessel, stir to homogenize and emulsify, then vacuum and cool. S6. Add Centella asiatica extract powder to propylene glycol and disperse for later use; S7. After the temperature of the reactor drops below 45°C, add step S6, p-hydroxyacetophenone, octyl glycol, and ethylhexylglycerin to the reactor in sequence and stir until homogeneous. S8. Finally, add tetrahydroxypropylethylenediamine to the reaction vessel and stir. Test the pH value and viscosity of the product. If they reach the specified range, the scar cream is obtained. The pH value is 5.0-6.5 and the viscosity is 80000mPa.s-120000mPa.s.

6. An application of a scar cream, characterized in that, The scar cream prepared by the method of any one of claims 1-4 or the method of preparing the scar cream of claim 5 is used in the preparation of skin scar removal products.

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