Scar repair composition and preparation method thereof

Abstract

The present invention relates to the field of skin repair products, and discloses a scar repair composition and a preparation method thereof. The preparation method comprises: mixing and homogenizing additives including emulsifiers and emollients in water, and completely emulsifying the grease in the additives to obtain an emulsion, wherein the emulsifier comprises polyglycerol-10 dipalmitate, polyglycerol-6 distearate and potassium cetyl alcohol phosphate; uniformly mixing the skin repair agent with the emulsion; and the skin repair agent comprises rice protein peptide, water-soluble Centella asiatica total glycosides extract, PDRN, vitamin B12 and lithospermum root extract. The scar repair composition has better stability and activity, and has a good effect on skin scar repair.

Description

Technical Field

[0001] The invention relates to the technical field of skin repair products, in particular to a scar repair composition and a preparation method thereof. Background Art

[0002] Scars are caused by excessive proliferation of collagen fibers in the wound area during the normal healing process after the human skin tissue is injured by various external traumas, infection, wound tension, and other external factors. The mechanism of scar formation is not yet fully understood. It is generally believed that the biological basis of scar formation is the massive proliferation and apoptosis inhibition of fibroblasts during wound repair, the imbalance between the synthesis and degradation of collagen in the extracellular matrix, and the abnormal expression of related cytokines.

[0003] Scars not only affect the appearance, but also the functions of related tissues or organs. In more serious cases, they can also cause deformities. With the improvement of living standards and people's pursuit of beauty, people are paying more and more attention to the repair of scars that affect the appearance of the skin. Therefore, safe and effective scar removal treatment methods have become a hot topic in the medical and cosmetic fields. At present, the treatment methods for scars mainly include drug therapy, physical therapy and surgical treatment. Drug therapy mainly promotes scar blood vessel contraction and inhibits fibrous tissue proliferation through local injection, thereby achieving the effect of scar treatment. Physical therapy mainly includes silicone membrane therapy, cryotherapy, laser therapy, etc.; surgical treatment uses scar excision and suture, skin grinding, scar release and local reshaping, scar excision free skin grafting, skin soft tissue expansion, etc. Although methods and various products for scar treatment have emerged in an endless stream in recent years, there are relatively few products with significant efficacy, high safety, high cost performance, easy use and industrial production, which are difficult to meet the needs of the market.

[0004] In view of this, the present invention is proposed. Summary of the invention

[0005] The purpose of the present invention is to provide a scar repair composition and a preparation method thereof.

[0006] The present invention is achieved in that:

[0007] In a first aspect, the present invention provides a method for preparing a scar repair composition, comprising:

[0008] The additives including emulsifiers and emollients are mixed and homogenized in water to completely emulsify the oils in the additives and the emollients to obtain an emulsion, wherein the emulsifiers include polyglyceryl-10 dipalmitate, polyglyceryl-6 distearate and potassium cetyl phosphate; the emollients include moisturizing oils and refreshing oils;

[0009] Mix the skin repair agent and emulsion evenly;

[0010] Skin repair agents include rice protein peptides, water-soluble Centella asiatica total glycosides extract, PDRN, vitamin B12, and Lithospermum officinale root extract;

[0011] By weight, the scar repair composition includes 0.5-3 parts of rice protein peptide, 0.5-2.5 parts of water-soluble Centella asiatica total glycosides extract, 0.1-0.25 parts of PDRN, 0.001-0.1 parts of vitamin B12, 0.001-0.02 parts of lithospermum root extract calculated by active ingredients, 0.5-2 parts of polyglycerol-10 dipalmitate, 0.5-2 parts of polyglycerol-6 distearate, 0.2-2 parts of potassium cetyl phosphate, 2-5 parts of moisturizing oil and 4-10 parts of refreshing oil.

[0012] In an optional embodiment, the additives further include a thickening stabilizer, a preservative, a polyol, and a pH adjuster;

[0013] Methods for homogenizing additives including emulsifiers and emollients in water include:

[0014] Mix the emollient and the emulsifier and heat to 85-90°C to obtain a mixed melt, and keep it warm for later use;

[0015] Disperse the thickening stabilizer, preservative and polyol in water, raise the temperature to 85-90°C to completely dissolve the thickening stabilizer and polyol, obtain a mixed solution, and keep it warm for later use;

[0016] The mixed melt and the mixed solution are mixed and homogenized, and after being fully emulsified, a primary emulsion is obtained;

[0017] When the primary emulsion is cooled to 70-75°C, a pH adjuster is added and mixed homogeneously to adjust the pH value of the system to 5.5-6.5 to obtain an emulsion.

[0018] In an optional embodiment, the emulsion temperature is lowered to below 45° C. before being mixed with the skin repair agent.

[0019] In an optional embodiment, in the scar repair composition, the thickening stabilizer is 0.1 to 3 parts, the preservative is 0.5 to 1 part, and the polyol is 3 to 11 parts.

[0020] In an optional embodiment, the moisturizing oil is selected from at least one of hydrogenated polyisobutene and shea butter;

[0021] The refreshing oil is selected from at least one of caprylic / capric triglyceride, ethylhexyl palmitate, jojoba seed oil, mahogany seed oil and polydimethylsiloxane.

[0022] In an optional embodiment, the thickening stabilizer is selected from at least one of carbomer, acrylic acid (esters) / C10-30 alkyl acrylate crosspolymer, ammonium acryloyldimethyl taurate / behenyl alcohol polyether-25 methacrylate crosspolymer, ammonium acryloyldimethyl taurate / stearyl alcohol polyether-25 methacrylate crosspolymer, ammonium polyacryloyldimethyl taurate, sodium polyacryloyldimethyl taurate, hydroxyethyl acrylate / sodium acryloyldimethyl taurate copolymer, sodium acrylate / sodium acryloyldimethyl taurate copolymer, xanthan gum and hydroxyethyl cellulose.

[0023] In an optional embodiment, the polyol is selected from at least one of glycerol, propylene glycol, butylene glycol, pentylene glycol, 1,2-pentanediol, 1,2-butylene glycol, 1,2-hexanediol, dipropylene glycol and methylpropylene glycol.

[0024] In an optional embodiment, the preservative is selected from at least two of 1,2-hexanediol, p-hydroxyacetophenone, caprylhydroxamic acid, chlorphenesin and sodium benzoate.

[0025] In an optional embodiment, the skin repair agent is mixed with the emulsion in a manner comprising:

[0026] Vitamin B12 and PDRN are added to the solvent, and ultrasonically treated at a frequency of 5-15 kHz and a power of 500-1000 W for 1-5 min to obtain a first process mixed solution;

[0027] The water-soluble Centella asiatica total glycosides extract is mixed with the first process mixed solution, and the microwave power is set to 90-110 W for microwave treatment for 1-3 minutes, and then the ultrasonic frequency is set to 3-6 kHz and the power is set to 200-350 W for ultrasonic treatment for 10-15 minutes to obtain the second process mixed solution;

[0028] The second process mixed solution, rice protein peptide and lithospermum root extract are sequentially added into the emulsion and mixed evenly.

[0029] In a second aspect, the present invention provides a scar repair composition, which is prepared by the preparation method of any one of the aforementioned embodiments.

[0030] The present invention has the following beneficial effects:

[0031] The preparation method of the scar repair composition provided by the embodiment of the present invention is to compound rice protein peptide, water-soluble Centella asiatica total glycoside extract, vitamin B12, PDRN and oil-soluble shikonin, which cooperate with each other and act synergistically. When applied to the scar repair composition, it can promote the degradation of accumulated type I collagen, significantly reduce the expression of fibronectin, reduce the density of fibroblasts, slow down the formation of scars, reduce the scar hyperplasia index, and have a significant scar repair effect; in addition, the scar repair composition containing the above components can provide sufficient nutrition for skin stromal cells, greatly accelerate the reconstruction speed of new skin tissue, repair the skin from the inside out, eliminate the possibility of infection and ulcers, make the new skin moisturized and smooth, remove scars and beautify the skin, and achieve skin repair and regeneration. The use of polyglyceryl-10 dipalmitate, polyglyceryl-6 distearate and potassium cetyl phosphate, these three substances form microemulsions with three coating layers to encapsulate the skin repair agent in the microemulsions, which can ensure that the skin repair agent maintains better activity and stability, thereby ensuring that the prepared scar repair composition has a good scar repair effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments are briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without creative work.

[0033] Figure 1 Flow chart for experimental rat handling. DETAILED DESCRIPTION

[0034] In order to make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the technical scheme in the embodiments of the present invention will be described clearly and completely below. If the specific conditions are not specified in the embodiments, they are carried out according to conventional conditions or conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments used is not specified, they are all conventional products that can be purchased commercially.

[0035] The embodiment of the present invention provides a method for preparing a scar repair composition, comprising:

[0036] The additives including emulsifiers and emollients are mixed and homogenized in water to completely emulsify the oils in the additives and the emollients to obtain an emulsion, wherein the emulsifiers include polyglyceryl-10 dipalmitate, polyglyceryl-6 distearate and potassium cetyl phosphate; the emollients include moisturizing oils and refreshing oils;

[0037] Mix the skin repair agent and emulsion evenly;

[0038] Skin repair agents include rice protein peptides, water-soluble Centella asiatica total glycosides extract, PDRN, vitamin B12, and Lithospermum officinale root extract;

[0039] By weight, the scar repair composition includes 0.5-3 parts of rice protein peptide, 0.5-2.5 parts of water-soluble Centella asiatica total glycosides extract, 0.1-0.25 parts of PDRN, 0.001-0.1 parts of vitamin B12, 0.001-0.02 parts of lithospermum root extract calculated by active ingredients, 0.5-2 parts of polyglycerol-10 dipalmitate, 0.5-2 parts of polyglycerol-6 distearate, 0.2-2 parts of potassium cetyl phosphate, 2-5 parts of moisturizing oil and 4-10 parts of refreshing oil.

[0040] Rice protein peptide comes from essence-rice endosperm in rice, adopts enzymatic process, is purified and refined, and its major part is oligopeptides with molecular weight less than 1000 dalton. Can significantly suppress tyrosinase activity, remove intracellular ROS, and reduce intracellular melanin content to a certain extent, effectively suppress the deposition of scar pigment. In the present application, preferably rice protein peptide oligopeptide content reaches more than 70% composite peptide, it has both extremely high safety, and nutritional characteristics also meet human body needs, thus no matter in human body absorption or transdermal absorption, can play better effect.

[0041] Centella asiatica can effectively assist fibroblast proliferation, strengthen the role of fibroblasts in the process of skin damage repair, accelerate the process of damage repair and improve the quality of damage repair; it can activate epithelial cells, promote the formation of normal granulation tissue, quickly renew connective tissue, promote the production of collagen, repair and link broken elastic fibers. The water-soluble Centella asiatica total glycoside extract involved in the present invention is an alcohol extract, and its main components are asiatica glycoside (about 20% by weight), hydroxy-madecassoside (about 60% by weight) and about 20% of other Centella asiatica extracts.

[0042] Oil-soluble shikonin has multiple biological activities, such as shikonin can inhibit the formation of scar tissue microvessels by inhibiting the expression of VEGF, thereby inhibiting collagen fiber synthesis and hypertrophic scar growth; it can promote the formation of granulation tissue, including cell migration and the formation of new blood vessels, and promote skin wound healing by promoting cell proliferation. The lithospermum root extract involved in each embodiment of the present invention contains about 1% shikonin as an active ingredient, and the remaining ingredients are acetic glycerol, that is, when the active ingredient content of the lithospermum root extract in the scar repair composition is 0.001-0.02 parts, the amount of the lithospermum root extract is 0.1-2 parts.

[0043] PDRN (Poly Deoxy Ribo Nucleotide) is a deoxyribonucleic acid (DNA) polymer extracted from salmon semen through a rigorous purification process, with high safety and stability. PDRN can bind to adenosine A2A receptors to activate multiple signaling pathways, increase anti-inflammatory factors, reduce inflammatory factors, and inhibit inflammatory responses; promote fibroblast proliferation, synthesis and secretion of collagen, promote EGF, FGF, IGF secretion, and reshape the internal environment of damaged skin; promote the expression of vascular endothelial growth factor (VEGF) to improve the skin repair process, generate capillaries, supply nutrients to repair the skin and excrete aging products; through the salvage pathway, provide purine or pyrimidine, accelerate DNA synthesis, and rapidly regenerate the skin.

[0044] Vitamin B12 is one of the B vitamins naturally found in food. It can accelerate cell renewal and regeneration; it also has a bactericidal effect, can participate in the nucleic acid metabolism of cells, increase the RNA synthesis of cells, and promote the renewal of vascular endothelial cells, interstitial cells and muscle cells in damaged skin, thereby improving the local microcirculation and tissue repair ability of skin tissue.

[0045] The preparation method of the scar repair composition provided by the embodiment of the present invention is to compound rice protein peptide, water-soluble Centella asiatica total glycoside extract, vitamin B12, PDRN and oil-soluble shikonin, which cooperate with each other and act synergistically. When applied to the scar repair composition, it can promote the degradation of accumulated type I collagen, significantly reduce the expression of fibronectin, reduce the density of fibroblasts, slow down the formation of scars, reduce the scar hyperplasia index, and have a significant scar repair effect; in addition, the scar repair composition containing the above components can provide sufficient nutrition for skin stromal cells, greatly accelerate the reconstruction speed of new skin tissue, repair the skin from the inside out, eliminate the possibility of infection and ulcers, make the new skin moisturized and smooth, remove scars and beautify the skin, and achieve skin repair and regeneration.

[0046] Since PDRN, vitamin B12 and water-soluble Centella asiatica total glycoside extract (madecassoside) in the skin repair agent have extremely strong ionicity, they are directly applied to scar repair products, which may cause problems such as heat instability, stratification, and deterioration. Therefore, if the skin repair agent is directly applied to scar repair products, the product shape will be unstable, the active ingredients in the skin repair agent will be easily deteriorated, and the effect of the skin repair agent will be difficult to fully exert. In response to this problem, an emulsifier is added during the preparation of the scar repair composition, which includes polyglycerol-10 dipalmitate, polyglycerol-6 distearate and potassium cetyl phosphate. These three substances form microemulsion droplets with three layers of coating to encapsulate the skin repair agent in the microemulsion droplets. The polyglycerol ester structure mainly consists of two parts: a hydrophilic head at one end and a hydrophobic tail at the other end. Taking polyglyceryl-6 distearate as an example, the hydrophilic head is composed of 6 units of glycerol, and the hydrophobic tail is composed of stearic acid; polyglyceryl-6 distearate is a diester structure, so it contains two hydrophobic tails, which makes the molecule more hydrophobic than hydrophilic; polyglyceryl-10 dipalmitate is also a diester structure, and like polyglyceryl-6 distearate, it is more hydrophobic than hydrophilic. In addition, these two polyglycerol esters have high salt tolerance. These two substances can coat the skin repair agent to improve the stability of the skin repair agent in scar repair products, making the scar repair composition more ion-resistant and the system more stable. Potassium cetyl phosphate can form vesicular liquid crystal structures and multilayer liquid crystal structures, which can coat the skin repair agent to improve the thermal stability of the skin repair agent.

[0047] Among the emollients, moisturizing oils can form a protective film on the wound surface, reduce the chance of external bacteria contacting the wound, reduce the risk of wound infection, prevent excessive loss of moisture from the skin around the wound, and prevent the wound from drying out and affecting healing. However, moisturizing oils are relatively thick, and if added too much, it will make it difficult for the skin repair agent to absorb. Adding an appropriate amount of moisturizing oil in the present invention helps promote wound healing and scar repair.

[0048] Therefore, the scar repair composition prepared by the preparation method provided by the present invention has good stability, can effectively inhibit scar hyperplasia, and promote the reconstruction of new skin tissue, thereby achieving a good scar removal and skin beautification effect.

[0049] Specifically, the preparation method is:

[0050] S1. Preparation of mixed melt

[0051] Mix the emollient and emulsifier and heat to 85-90°C, stir and melt into liquid to obtain a mixed melt, and keep warm for later use.

[0052] Emulsifiers include polyglyceryl-10 dipalmitate, polyglyceryl-6 distearate, and potassium cetyl phosphate.

[0053] Optionally, the moisturizing oil is selected from at least one of hydrogenated polyisobutene and shea butter; the refreshing oil is selected from at least one of caprylic / capric triglyceride, ethylhexyl palmitate, jojoba seed oil, mahogany seed oil and polydimethylsiloxane.

[0054] S2. Preparation of mixed solution

[0055] Disperse the thickening stabilizer, preservative and polyol in water and stir evenly, raise the temperature to 85-90°C to completely dissolve the thickening stabilizer, preservative and polyol to obtain a mixed solution, and keep it warm for later use.

[0056] Optionally, the mixing process can also be homogenized, and the homogenization time is 3 to 5 minutes.

[0057] Optionally, the heat preservation time is at least 20 minutes to achieve the effect of sterilization and defoaming.

[0058] Optionally, the thickening stabilizer is selected from at least one of carbomer, acrylic acid (esters) / C10-30 alkyl acrylate crosspolymer, ammonium acryloyldimethyl taurate / behenyl alcohol polyether-25 methacrylate crosspolymer, ammonium acryloyldimethyl taurate / stearyl alcohol polyether-25 methacrylate crosspolymer, ammonium acryloyldimethyl taurate, sodium polyacryloyldimethyl taurate, hydroxyethyl acrylate / sodium acryloyldimethyl taurate copolymer, sodium acrylate / sodium acryloyldimethyl taurate copolymer, xanthan gum, and hydroxyethyl cellulose.

[0059] Optionally, the polyol is selected from at least one of glycerol, propylene glycol, butylene glycol, pentylene glycol, 1,2-pentanediol, 1,2-butylene glycol, 1,2-hexanediol, dipropylene glycol, and methylpropylene glycol.

[0060] Optionally, the amount of preservative added is 0.5~1 part.

[0061] Optionally, the preservative is selected from at least two of 1,2-hexanediol, p-hydroxyacetophenone, caprylhydroxamic acid, chlorphenesin and sodium benzoate, and preferably the addition amount of each of the at least two is the same.

[0062] S3, homogeneous mixing

[0063] The mixed solution is slowly added to the mixed melt. Homogenization is started during the addition process. After the addition is completed, homogenization is performed for 3 to 5 minutes until it is fully emulsified, and then defoaming is performed to obtain a primary emulsion.

[0064] S4. Adjust pH

[0065] The primary emulsion is cooled to 70-75°C (e.g., 70°C, 73°C, or 75°C), a pH adjuster is added thereto, and mixed and homogenized for 2-3 minutes (e.g., 2 minutes, 2.5 minutes, or 3 minutes), and the pH value of the system is adjusted to 5.5-6.5 to obtain an emulsion.

[0066] Optionally, the pH adjuster is selected from at least one of arginine, sodium hydroxide and triethanolamine.

[0067] The amount of pH adjuster added is usually 0.2 to 0.8 parts.

[0068] S5. Add skin repair agent

[0069] Vitamin B12 and PDRN are added to the solvent, and ultrasonic treatment is performed at a frequency of 5-15 kHz (e.g., 5 kHz, 10 kHz, or 15 kHz) and a power of 500-1000 W (e.g., 500 W, 800 W, or 1000 W) for 1-5 min (e.g., 1 min, 3 min, or 5 min) to obtain a first process mixed solution.

[0070] Preferably, in the process of obtaining the first process mixed liquid, the ultrasonic frequency is 8-12 kHz (e.g., 8 kHz, 10 kHz or 12 kHz), the power is 500-800 W (e.g., 500 W, 600 W or 800 W), and the time is 3-5 min (e.g., 3 min, 4 min or 5 min).

[0071] The water-soluble Centella asiatica total glycosides extract is mixed with the first process mixed solution, and the microwave power is set to 90-110 W (for example, 90 W, 100 W or 110 W) for microwave treatment for 1-3 min (for example, 1 min, 2 min or 3 min), and then the ultrasonic frequency is set to 3-6 kHz (for example, 3 kHz, 5 kHz or 6 kHz) and the power is set to 200-350 W (for example, 200 W, 300 W or 350 W) for ultrasonic treatment for 10-15 min (for example, 10 min, 12 min or 15 min) to obtain a second process mixed solution;

[0072] The second process mixed solution, rice protein peptide and Lithospermum officinale root extract are sequentially added into the emulsion and mixed evenly to obtain a scar repairing composition.

[0073] By mixing vitamin B12, PDRN and water-soluble Centella asiatica total glycoside extract through ultrasound and microwave, they can be presented in a uniform small molecule state. In the subsequent preparation of creams and essences, ultrasound and microwave can be used to dissolve the active ingredients more completely and easily penetrate into the cortex, so that they can exert their effects more fully.

[0074] Optionally, in the scar repair composition, the thickening stabilizer is 0.5 to 3 parts, the emollient is 6 to 15 parts, and the polyol is 3 to 11 parts.

[0075] Preferably, on the basis of ensuring better use effect, from the perspectives of manufacturing cost, product stability, etc., the scar repair composition is calculated by weight, and its total amount is 100 parts, including 0.5-3 parts of rice protein peptide, 0.5-2.5 parts of water-soluble Centella asiatica total glycosides extract, 0.1-0.25 parts of PDRN, 0.001-0.1 parts of vitamin B12, and 0.001-0.02 parts of lithospermum root extract, calculated by active ingredients, 0.5-2 parts of polyglycerol-10 dipalmitate, 0.5-2 parts of polyglycerol-6 distearate, 0.2-2 parts of potassium cetyl phosphate, 0.5-3 parts of thickening stabilizer, 6-15 parts of emollient, 3-10 parts of polyol, 0.5-1 parts of preservative, 0.2-0.8 parts of pH adjuster, and the balance of water.

[0076] During the whole preparation process, controlling the temperature at different stages can provide a better mixing effect for the composition. Under this condition, it is also beneficial for the composition to maintain a relatively stable special structure and maintain activity for a long time.

[0077] A scar repair composition provided by an embodiment of the present invention is prepared by using a preparation method provided by an embodiment of the present invention.

[0078] The features and performance of the present invention are further described in detail below in conjunction with the embodiments.

[0079] Examples 1-3 and Comparative Examples 1-11

[0080] The emollient and emulsifier are mixed and heated to 90°C, stirred and melted into a liquid to obtain a mixed melt, which is kept warm for later use.

[0081] Disperse the thickening stabilizer, preservative and polyol in water, stir evenly, and homogenize for 4 minutes. Raise the temperature to 90°C to completely dissolve the thickening stabilizer, preservative and polyol to obtain a mixed solution. Keep the solution warm for 20 minutes and continue to keep the solution warm for later use.

[0082] The mixed solution was slowly added to the mixed melt, and homogenization was started during the addition process. After the addition was completed, homogenization was performed for 4 minutes until fully emulsified, and then defoaming was performed to obtain a primary emulsion.

[0083] The primary emulsion was cooled to 70-75°C, a pH adjuster was added thereto, and the mixture was homogenized for 3 minutes to adjust the pH value of the system to 5.5-6.5 to obtain an emulsion.

[0084] Vitamin B12 and PDRN were added to the solvent, and ultrasonic treatment was performed at a frequency of 10 kHz and a power of 800 W for 4 min to obtain a first process mixed solution.

[0085] The water-soluble Centella asiatica total glycosides extract was mixed with the first process mixed solution, and the microwave power was set to 100 W for microwave treatment for 2 minutes, and then the ultrasonic frequency was set to 5 kHz and the power was set to 300 W for ultrasonic treatment for 12 minutes to obtain the second process mixed solution;

[0086] The second process mixed solution, rice protein peptide and Lithospermum officinale root extract are sequentially added into the emulsion and mixed evenly to obtain a scar repairing composition.

[0087] The group distribution ratios of Examples 1 to 3 are shown in Table 1, the group distribution ratios of Comparative Examples 1-6 are shown in Table 2, and the group distribution ratios of Comparative Examples 7-11 are shown in Table 3.

[0088] Table 1 The composition ratio of each embodiment and

[0089]

[0090] Table 2 Group distribution ratio of each comparative example

[0091]

[0092] Table 3 Group distribution ratio of each comparative example

[0093]

[0094] Example 4

[0095] This embodiment is basically the same as the embodiment 1, except that the components of the skin repair agent are directly added to the emulsion and stirred and mixed without being homogenized in advance to prepare the first process mixed liquid.

[0096] The obtained paste has poor uniformity, which is predictable due to its poor storage stability.

[0097] Comparative Example 11

[0098] Competitive product A is a high-selling product on the market.

[0099] Comparative Example 12

[0100] Competitor B is a high-selling product on the market.

[0101] Experimental Example 1

[0102] 1. Materials and methods

[0103] 1.1. Scar repair cream control group, various embodiments and comparative examples, a total of 18 groups of samples.

[0104] 1.2 Experimental animals and modeling methods: 90 female SD rats weighing (250±25) g were selected and divided into 18 groups. One group was used as the control group. After local hair removal, no other treatment was performed. After anesthesia, the rats in the other groups were prepared and disinfected on the back. An open circular wound with a diameter of 2 cm was created on the back of the rats, with a full-thickness skin defect to the deep layer of the myofascia. Hemostasis was performed and the wound was set aside for later use. (If Figure 1 ).

[0105] Experimental grouping and administration method: Each group was administered according to the conventional dosage and usage of the product (apply the scar repair cream to the wound surface with a cotton swab, twice a day). The wound area was recorded and measured, and the scar removal rate was calculated. The results are shown in Table 4.

[0106] Table 4 Examples and Comparative Examples

[0107]

[0108] Scar removal rate = (original wound area - current abnormal skin area) / original scar area * 100%. Here, "abnormal skin area" includes wounds without scabs, scabs, and scars after scabs fall off.

[0109] During the above experiments, the wounds of the examples were almost completely healed and the scabs fell off in about 14 days, and the wounds of the comparative examples were completely healed and the scabs fell off in about 21 days.

[0110] Since scar formation takes a short time and the skin itself has a certain self-healing ability, the area of ​​abnormal skin in Comparative Example 1 decreases with time, but it cannot be completely restored to normal skin state. Since the measurement relies on the area method, there are errors. The healing area of ​​Comparative Example 1 in the first week is small and difficult to measure, and the removal rate is expressed as 0%. At the same time, it can be seen that the scar repair cream provided by the present invention can effectively remove scars formed after trauma in rats and improve the rate of scar removal. Although the example still has mouse scars that have not been completely removed after 60 days of use, the scar removal rate has reached more than 96%, indicating that the scar repair cream provided by the present invention has a better scar repair effect.

[0111] At present, the scar repair cream with better effect on the market is tested by the above experimental method, and the effect after 30 days of use is generally not more than 70%. It is generally believed that the scar repair rate exceeds 60% after 30 days of use, which is considered to have better scar repair effect.

[0112] It can be seen from Table 4 that the scar repairing creams provided by various embodiments of the present invention have obvious scar repairing effects.

[0113] Comparing Comparative Example 1 with Example 1, since no skin repair agent is added in Comparative Example 1, it has almost no scar repair effect.

[0114] Comparing Comparative Examples 2 to 6 with Example 1, although Comparative Examples 2 to 6 also have better effects on scar repair, their effects are still generally worse than those of Example 1, indicating that the five components in the skin repair composition have a synergistic effect in skin repair, and the lack of any one of them will reduce the effect of skin repair.

[0115] The amount of emollient added in Comparative Examples 7 and 8 is different from that in Examples 2 and 3, respectively. Comparative Examples 7 and 8 are compared with the scar repair of Examples 2 and 3, respectively. Although they have certain effects on scar repair, the effects of both are significantly worse than those of Examples 2 and 3, indicating that it is difficult to achieve better results when the amount of emollient is more or less than the amount required by the present invention.

[0116] The amount of moisturizing oil added in the emollients of Comparative Examples 9 and 10 is different from that in Examples 2 and 3, respectively. The repair effects of Comparative Examples 9 and 10 are compared with Examples 2 and 3, respectively. The effects of Comparative Examples 9 and 10 are significantly worse. Compared with Example 2, shea butter (moisturizing oil) is not added in Comparative Example 9; compared with Example 3, shea butter (moisturizing oil) accounts for 8%, indicating that in the formula, the change of oil usually directly affects the final effect of the product. In the scar repair cream, oil is one of the main ingredients. If the proportion of moisturizing oil changes, the repair effect of the scar repair cream on the scar will be worse, especially if the amount of moisturizing oil is too much, the texture of the product will change from light to greasy, the skin feel will be heavier, and it will be difficult for the skin to absorb, which will directly affect the scar repair effect of the product.

[0117] Experimental Example 2

[0118] Human skin patch test

[0119] 1. Test product: the scar repair composition provided in Examples 1-3;

[0120] 2. Test method: Select a qualified patch tester with an area of ​​no more than 50mm² and a depth of about 1mm. Use a closed patch test method to add about 0.020-0.025g of the scar repair composition to the patch tester, apply it to the curved side of the subject's forearm with a low-allergenic tape, and gently press it with the palm of your hand to evenly apply it to the skin. Remove the test article after 24 hours, and observe the skin reaction 0.5h (after the indentation disappears), 24h, and 48h after removal, and record the results according to the skin reaction grading standard in the "Safety Technical Specifications for Cosmetics" (2015 edition);

[0121] 3. Test site: curved side of forearm;

[0122] 4. The grading standards for adverse skin reactions are shown in Table 5.

[0123] Table 5 Skin grading standards

[0124]

[0125] 5. Test results

[0126] Table 6 Scoring results of various embodiments and comparative examples

[0127]

[0128] A total of 30 subjects were recruited and all 30 subjects completed the test. The results showed that the scores of the 30 subjects at the three observation time points of 0.5h, 24h, and 48h after the patch was removed were all 0 points.

[0129] 6. Results description:

[0130] With reference to the grading standard for adverse skin reactions in human safety tests specified in the 2015 edition of the "Technical Specifications for Safety of Cosmetics", no adverse skin reactions were observed in 30 subjects, thus it can be concluded that the scar repair composition of the present invention has no adverse skin reactions on the human body.

[0131] 7. Subject selection

[0132] After screening by dermatologists, 30 subjects were enrolled. Finally, 30 subjects were counted, ranging in age from 18 to 49 years old, with an average age of (25.10±7.88) years old. All completed subjects met the following inclusion and exclusion criteria.

[0133] 1 Inclusion criteria

[0134] 1.1 Healthy men and women aged 18-55 years old;

[0135] 1.2 Able to cooperate with the test, read and understand the contents of the informed consent form, and voluntarily sign the informed consent form;

[0136] 2 Exclusion criteria

[0137] 2.1 Those who have used antihistamines in the past week or immunosuppressants in the past month;

[0138] 2.2 Those who have used any anti-inflammatory drugs on the test site in the past two months;

[0139] 2.3 Subjects suffering from inflammatory skin diseases that have not been clinically cured;

[0140] 2.4 Patients with insulin-dependent diabetes mellitus;

[0141] 2.5 Patients who are receiving treatment for asthma or other chronic respiratory diseases;

[0142] 2.6 Those who have received anti-cancer chemotherapy in the past 6 months;

[0143] 2.7 Patients with immunodeficiency or autoimmune diseases;

[0144] 2.8 Women who are breastfeeding or pregnant;

[0145] 2.9 Patients who have undergone bilateral mastectomy and bilateral axillary lymph node removal;

[0146] 2.10 The judges whose test results may be affected by scars, pigmentation, atrophy, port wine stains or other blemishes on the skin to be tested;

[0147] 2.11 Participating in other clinical trial researchers;

[0148] 2.12 People with highly sensitive constitutions;

[0149] 2.13 Non-voluntary participants or those who are unable to complete the required content according to the trial requirements.

[0150] Table 7 Skin reactions of 30 subjects at different observation times

[0151]

[0152] In summary, the scar repair composition prepared by the preparation method provided in the embodiment of the present invention has good stability, can effectively inhibit scar hyperplasia, and promote the reconstruction of new skin tissue, thereby achieving a good scar removal and skin beautification effect.

[0153] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A method for preparing a scar repair composition, characterized in that: include: Mixing additives including emulsifiers and emollients in water and homogenizing them, so that the oils in the additives and the emollients are completely emulsified to obtain an emulsion, wherein the emulsifiers include polyglyceryl-10 dipalmitate, polyglyceryl-6 distearate and potassium cetyl phosphate; and the emollients include moisturizing oils and refreshing oils; Mixing the skin repair agent and the emulsion evenly; The skin repair agent comprises rice protein peptide, water-soluble Centella asiatica total glycosides extract, PDRN, vitamin B12 and Lithospermum officinale root extract; In parts by weight, the scar repair composition includes 0.5-3 parts of rice protein peptide, 0.5-2.5 parts of water-soluble Centella asiatica total glycosides extract, 0.1-0.25 parts of PDRN, 0.001-0.1 parts of vitamin B12, 0.001-0.02 parts of lithospermum root extract calculated by active ingredients, 0.5-2 parts of polyglycerol-10 dipalmitate, 0.5-2 parts of polyglycerol-6 distearate, 0.2-2 parts of potassium cetyl phosphate, 2-5 parts of the moisturizing oil and 4-10 parts of the refreshing oil; The moisturizing oil is selected from at least one of hydrogenated polyisobutylene and shea butter; The refreshing oil is selected from at least one of caprylic / capric triglyceride, ethylhexyl palmitate, jojoba seed oil, mahogany seed oil and polydimethylsiloxane.

2. The preparation method according to claim 1, characterized in that: The additives also include thickening stabilizers, preservatives, polyols and pH adjusters; Methods for homogenizing additives including emulsifiers and emollients in water include: The emollient and the emulsifier are mixed and heated to 85-90° C. to obtain a mixed melt, and the mixture is kept warm for later use; Dispersing the thickening stabilizer, the preservative and the polyol in water, raising the temperature to 85-90° C. to completely dissolve the thickening stabilizer and the polyol to obtain a mixed solution, and keeping the solution warm for later use; The mixed melt and the mixed solution are mixed and homogenized, and after being fully emulsified, a primary emulsion is obtained; When the primary emulsion is cooled to 70-75° C., the pH adjuster is added and mixed homogeneously to adjust the pH value of the system to 5.5-6.5 to obtain the emulsion.

3. The preparation method according to claim 2, characterized in that: When the temperature of the emulsion drops below 45° C., it is mixed with the skin repairing agent.

4. The preparation method according to claim 2, characterized in that: In the scar repair composition, the thickening stabilizer is 0.1 to 3 parts, the preservative is 0.5 to 1 part, and the polyol is 3 to 11 parts.

5. The preparation method according to claim 4, characterized in that: The thickening stabilizer is selected from at least one of carbomer, acrylic acid (esters) / C10-30 alkyl acrylate crosspolymer, ammonium acryloyldimethyl taurate / behenyl alcohol polyether-25 methacrylate crosspolymer, ammonium acryloyldimethyl taurate / stearyl alcohol polyether-25 methacrylate crosspolymer, ammonium polyacryloyldimethyl taurate, sodium polyacryloyldimethyl taurate, hydroxyethyl acrylate / sodium acryloyldimethyl taurate copolymer, sodium acrylate / sodium acryloyldimethyl taurate copolymer, xanthan gum and hydroxyethyl cellulose.

6. The preparation method according to claim 4, characterized in that: The polyol is selected from at least one of glycerol, propylene glycol, butylene glycol, pentylene glycol, 1,2-pentanediol, 1,2-butylene glycol, 1,2-hexanediol, dipropylene glycol and methylpropylene glycol.

7. The preparation method according to claim 4, characterized in that: The preservative is selected from at least two of 1,2-hexanediol, p-hydroxyacetophenone, caprylhydroxamic acid, chlorphenesin and sodium benzoate.

8. The preparation method according to claim 2, characterized in that: The method of mixing the skin repair agent with the emulsion includes: The vitamin B12 and the PDRN are added to a solvent, and ultrasonically treated for 1 to 5 minutes at a frequency of 5 to 15 kHz and a power of 500 to 1000 W to obtain a first process mixed solution; The water-soluble Centella asiatica total glycosides extract is mixed with the first process mixed solution, and microwave treatment is performed at a microwave power of 90-110 W for 1-3 min, and then ultrasonic treatment is performed at an ultrasonic frequency of 3-6 kHz and a power of 200-350 W for 10-15 min to obtain a second process mixed solution; The second process mixed liquid, the rice protein peptide and the lithospermum root extract are sequentially added into the emulsion and mixed evenly.

9. A scar repair composition, characterized in that: The method is prepared according to any one of claims 1 to 8.

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