A skin care patch containing a bovine collagen and a method for preparing the same

Abstract

This invention discloses a skin repair dressing containing Pro-Xylane and its preparation method, relating to the field of skin care technology. By weight, it comprises the following components: Pro-Xylane: 0.8-1.2 parts, Sodium hyaluronate: 0.05-0.1 parts, Glycerin: 6.0-10.0 parts, Carbomer: 0.2-0.4 parts, Trehalose: 0.8-1.2 parts, p-hydroxyacetophenone: 0.3-0.5 parts, Caprylic / Capric triglyceride: 4.0-6.0 parts, Montanov L: 2.5-3.5 parts, Cetyl ethylhexanoate: 4.5 parts. The total weight of the components is 100 parts: 5.5 parts squalane, 2.5-3.5 parts 1,2-hexanediol, 0.8-1.2 parts triethanolamine, and the remainder is purified water. This invention creates a dressing system suitable for skin repair, combining active ingredients and functional excipients. Multiple components work synergistically to balance efficacy and skin feel, adapting to various skin repair conditions. At the same time, a standardized preparation process is designed to control parameters at each stage, ensuring uniformity and stability of each phase, protecting active ingredients, removing impurities and ensuring sterility, thereby improving product safety and stability.

Description

Technical Field

[0001] This invention relates to the field of skin care technology, specifically to a skin repair dressing containing styrofoam and its preparation method. Background Technology

[0002] As the largest organ in the human body, the skin plays a vital physiological role in barrier protection and sensing the external environment. Under the influence of various factors such as environmental stimuli, improper skincare, and skin aging, the skin barrier is easily damaged, manifesting as discomfort such as dryness, sensitivity, and redness. Therefore, the research and application of skin repair dressings has become a key focus in the skincare field. Pro-Xylane, as an active ingredient with excellent skin repair effects, can act on the skin matrix layer, helping to maintain the integrity of the skin structure and is widely used in various repair-type skincare products. Meanwhile, ingredients such as sodium hyaluronate and squalane, due to their moisturizing and soothing effects, have also become common raw materials for skin repair dressings. The industry often uses a combination of multiple active ingredients and functional excipients to create skincare products with multiple functions, including repair and moisturizing. Achieving a scientific ratio and synergistic effect among the various ingredients has become a key direction for improving the efficacy of skin repair dressings.

[0003] The existing technology, CN116370384A, entitled "A Pro-Xylane Repair Cream and Its Preparation Method," achieves skin repair by combining Pro-Xylane with active peptides, pomegranate peel extract, and other ingredients. However, the high proportion of Pro-Xylane in this formula can significantly increase raw material costs. Furthermore, the formula relies solely on hydroxypropyl-β-cyclodextrin for emulsification and stability, limiting its control over the compatibility between the oil and aqueous phases. This poses a risk of emulsification failure during long-term storage. Additionally, its preparation process simply separates the oil... The preparation of the aqueous phase and homogenization emulsification steps lacked precise control over temperature, stirring rate, and homogenization parameters at each stage. This not only made it difficult to guarantee the retention rate of active ingredients but also easily led to problems such as uneven particle size distribution and sticky skin feel. In addition, the formula design of this repair cream focuses on anti-aging and wrinkle reduction, and does not adequately consider the basic moisturizing and soothing repair needs after the skin barrier is damaged. It cannot achieve comprehensive care for dry, sensitive and other damaged skin, and has a narrow range of applicable skin types, making it difficult to meet the diverse usage needs of skin repair products. Summary of the Invention

[0004] The purpose of this invention is to overcome the shortcomings of existing technologies and provide a skin repair dressing containing Proxylane and its preparation method. The dressing uses hydroxypropyl tetrahydropyranotriol as the core component of Proxylane, combined with sodium hyaluronate of different molecular weights, various moisturizers, oil components, and functional excipients. The scientific ratio of each component forms a synergistic effect. The preparation process involves aqueous and oil phase preparation, followed by homogenization emulsification, neutralization and cooling, active ingredient addition, and filtration and filling steps. Each step is precisely controlled to ensure the activity of the components and the stability of the system. The source of raw materials, the ratio, and the details of the process operation are also optimized. This dressing has repair and moisturizing effects, can repair the skin barrier, has a stable texture, is safe to use, and the preparation process is standardized and easy to industrialize. It is suitable for the care of various damaged skin and has good application value in the skin care field.

[0005] To solve the above-mentioned technical problems, the present invention provides the following technical solution: In one aspect, a skin repair dressing containing Pro-Xylane, comprising, by weight, the following components: Pro-Xylane: 0.8-1.2 parts, sodium hyaluronate: 0.05-0.1 parts, glycerin: 6.0-10.0 parts, carbomer: 0.2-0.4 parts, trehalose: 0.8-1.2 parts, p-hydroxyacetophenone: 0.3-0.5 parts, caprylic / capric triglyceride: 4.0-6.0 parts, Montanov L: 2.5-3.5 parts, cetyl ethylhexanoate: 4.5-5.5 parts, squalane: 2.5-3.5 parts, 1,2-hexanediol: 0.8-1.2 parts, triethanolamine: 0.2-0.4 parts, with the balance being purified water, the total weight of all components being 100 parts; wherein Pro-Xylane is hydroxypropyl tetrahydropyranotriol.

[0006] Furthermore, the sodium hyaluronate is composed of low molecular weight sodium hyaluronate and medium molecular weight sodium hyaluronate in a weight ratio of 7:3, wherein the molecular weight of the low molecular weight sodium hyaluronate is 1000-5000 Da and the molecular weight of the medium molecular weight sodium hyaluronate is 10000-20000 Da.

[0007] Furthermore, the weight ratio of caprylic / capric triglyceride, cetyl ethylhexanoate, and squalane is 1:(0.9-1.1):(0.5-0.7); wherein the caprylic / capric triglyceride is derived from coconut oil extraction, the cetyl ethylhexanoate is a synthetic grade raw material, and the squalane is derived from olive oil refining.

[0008] Furthermore, the MontanovL is a complex of phytosterol and cetyl alcohol, wherein the content of phytosterol is 40%-60% and the content of cetyl alcohol is 40%-55% based on the total weight of the complex, and the HLB value of the complex is 8-10.

[0009] On the other hand, a method for preparing a skin repair dressing containing styrofoam, the specific steps of which are as follows: S1, Aqueous phase preparation: Weigh out the prescribed amounts of sodium hyaluronate, glycerol, trehalose, carbomer, p-hydroxyacetophenone, 1,2-hexanediol and purified water, stir evenly and heat to 75-80℃, keep warm for 15-20 min to obtain the aqueous phase matrix. S2, Oil phase preparation: Weigh the prescribed amounts of caprylic / capric triglyceride, Montanov L, cetyl ethylhexanoate, and squalane, heat to 70-75℃, stir until completely melted and mixed evenly to obtain the oil phase matrix; S3, Homogenization and Emulsification: Maintain the temperature at 70-75℃, slowly add the oil phase matrix to the aqueous phase matrix, and homogenize and emulsify at a speed of 1500-1800r / min for 10-15min to form an emulsion; S4, Neutralization and Cooling: Stop heating and allow the emulsion to cool naturally to 45-50℃. Add the prescribed amount of triethanolamine and stir to neutralize until the pH of the system is 5.5-6.5. Continue stirring for 10 minutes. S5, Active Addition: After the emulsion cools to 35-40℃, add the prescribed amount of BOXER and stir well; S6, Post-processing: The mixture is filtered and aseptically filled to obtain a skin repair dressing containing BOXEL.

[0010] Furthermore, the stirring is carried out using an anchor-type stirrer with an initial stirring speed of 300-400 r / min, continuous stirring for 5-8 min, a water bath heating rate of 5℃ / min, and stirring at 200 r / min for 1 min every 3 min during the heat preservation period.

[0011] Furthermore, the oil phase matrix is ​​injected into the aqueous phase matrix via a sterile infusion pump at a rate of 5-10 ml / min, and the shear head of the high-speed shear homogenizer is inserted into the system to a depth of 1 / 2 below the liquid surface.

[0012] Furthermore, the natural cooling rate of the emulsion is 2-3℃ / min, and triethanolamine is added through a constant pressure dropping funnel at a dropping rate of 1-2ml / min, with the funnel outlet close to the liquid surface during addition.

[0013] Furthermore, the Bosein is added slowly along the stirring direction, and the stirring speed is adjusted in stages: initially at 300 r / min for 5 min, in the middle stage at 350 r / min for 10 min, and in the later stage at 400 r / min for 5 min, with the system temperature maintained at 35-40℃ throughout.

[0014] Furthermore, the filtration uses a 0.22μm sterile filter membrane made of polyethersulfone, the filtration pressure is controlled at 0.2-0.3MPa, and aseptic filling is carried out in a Class 100 clean area. Beneficial effects

[0015] Compared with existing technologies, this skin repair dressing containing PHOXY and its preparation method have the following beneficial effects: I. This invention creates a dressing system tailored to skin repair needs by combining suitable skincare active ingredients and functional excipients. The core active ingredient, Pro-Xylane, can target the skin repair process. Combined with sodium hyaluronate of different molecular weights, it achieves moisturizing and repairing at different levels of the skin. Multiple moisturizing ingredients work synergistically to improve skin hydration and enhance the skin barrier's water-locking ability. The oil-based ingredients are selected from a reasonable combination of natural and synthetic raw materials, taking into account both skin feel and efficacy. The complex of phytosterols and cetyl alcohol serves as an emulsifying agent, making the system more stable. The proportions of various ingredients have been optimized to form a synergistic effect, ensuring the effective performance of active ingredients while giving the dressing a good texture and feel, reducing skin irritation, and making it suitable for various skin conditions requiring repair.

[0016] II. This invention employs a standardized and refined preparation process, setting appropriate temperatures and treatment methods for both the aqueous and oil phases to ensure the uniformity and stability of each phase matrix. Controlling the process parameters during homogenization and emulsification allows the oil and aqueous phases to fully integrate, forming a stable emulsion system and preventing issues such as layering and oil separation. Temperature and operational control during neutralization cooling and active ingredient addition effectively protect the activity of active ingredients such as styrene from degradation, ensuring the dressing's repair efficacy. Subsequent filtration and aseptic filling processes remove impurities from the system while maintaining the dressing's sterility, reducing the possibility of microbial contamination of the skin during use. The overall process ensures controllable dressing quality, effectively preserving the efficacy of each component and enhancing the product's safety and stability.

[0017] Other advantages, objectives and features of the invention will be set forth in part in the description which follows, and in part will be apparent to those skilled in the art from the following examination or study, or may be learned from the practice of the invention. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the accompanying drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are merely some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without any creative effort.

[0019] Figure 1 A process flow diagram for preparing skin repair dressings containing BP-Xylane; Figure 2 A simplified schematic diagram of the preparation process for a skin repair dressing containing BP-Xylane; Figure 3 A diagram illustrating the core processes and parameters for preparing skin repair dressings containing BPOXY. Detailed Implementation

[0020] To further illustrate the technical means and effects of the present invention in achieving its intended purpose, the following detailed description of the specific implementation methods, structures, features, and effects of the present invention, in conjunction with the accompanying drawings and preferred embodiments, is provided below. Example

[0021] Preparation of a skin repair dressing containing styroxin.

[0022] Raw material preparation: Prepare in advance the following raw materials: hydroxypropyl tetrahydropyranotriol-type Bosein; sodium hyaluronate (low molecular weight 1000-5000 Da, medium molecular weight 10000-20000 Da, mixed in a 7:3 weight ratio); glycerin; carbomer; trehalose; p-hydroxyacetophenone; caprylic / capric triglyceride derived from coconut oil; Montanov L (composed of phytosterols and cetyl alcohol); synthetic-grade cetyl ethylhexanoate; squalane refined from olive oil; 1,2-hexanediol; triethanolamine; and purified water. All raw materials undergo purity testing beforehand to ensure they are free of impurities and deterioration. After passing the tests, they are placed in a constant temperature environment at 25°C for 2 hours to equilibrate, ensuring consistent raw material temperature and preventing temperature differences from affecting system stability during subsequent preparation.

[0023] Dressing preparation, specific steps are as follows: Figure 1 As shown: Accurately weigh the following components by weight: 1.0 part of Bosein, 0.08 parts of sodium hyaluronate, 8.0 parts of glycerin, 0.3 parts of carbomer, 1.0 part of trehalose, 0.4 parts of p-hydroxyacetophenone, 5.0 parts of caprylic / capric triglyceride, 3.0 parts of Montanov L, 5.0 parts of cetyl ethylhexanoate, 3.0 parts of squalane, 1.0 part of 1,2-hexanediol, 0.3 parts of triethanolamine, and 72.92 parts of purified water, for a total weight of 100 parts. The weight ratio of caprylic / capric triglyceride, cetyl ethylhexanoate, and squalane is 1:1:0.6. Montanov L contains 50% phytosterols, 48% cetyl alcohol, and has an HLB value of 9.

[0024] S1, Aqueous Phase Preparation: Weigh out sodium hyaluronate, glycerol, trehalose, carbomer, p-hydroxyacetophenone, 1,2-hexanediol, and purified water, and add them all to a stainless steel reaction vessel. Use an anchor stirrer to stir the mixture, initially setting the stirring speed to 350 rpm, and continue stirring for 7 minutes. Continuously observe the system's state during stirring until the system is free of particulate matter and exhibits a uniform, transparent state. Then, use a water bath to slowly heat the system to 78°C, strictly controlling the heating rate at 5°C / min. After reaching the set temperature, maintain this temperature for 18 minutes, stirring at 200 rpm for 1 minute every 3 minutes during this period to prevent localized overheating or component precipitation. The final result is a uniform, transparent, and impurity-free aqueous matrix. Figure 2 As shown.

[0025] S2, Oil phase preparation: Weigh out the octanoic acid / capric acid triglyceride, Montanov L, cetyl ethylhexanoate, and squalane and put them into another independent stainless steel reaction vessel. Heat the system to 73°C using a water bath heating method. Stir continuously during the heating process until all oil phase components are completely melted and the system is uniformly mixed and presents a clear, transparent state without impurities. Stop heating and maintain the temperature to obtain the oil phase matrix.

[0026] S3, Homogenization and Emulsification: The temperatures of both the aqueous and oil phase matrices are maintained stably at 73℃. The oil phase matrices are slowly injected into the aqueous phase matrices using a sterile infusion pump, with the injection rate strictly controlled at 8 ml / min. The aqueous phase matrices are continuously stirred during the injection process. The shear head of a high-speed shear homogenizer is vertically inserted to the lower half of the aqueous phase matrix surface. The homogenization and emulsification operation is started, and the homogenization speed is set to 1600 r / min. Homogenization and emulsification are continued for 13 minutes, with the system status observed in real time during the emulsification process, until a uniform, fine emulsion without oil droplets or particles is formed, at which point homogenization is stopped.

[0027] S4, Neutralization and Cooling: Turn off all heating devices and allow the emulsion to cool naturally at a rate of 2.5℃ / min. When the emulsion temperature drops to 48℃, slowly add the weighed triethanolamine into the system through a constant pressure dropping funnel at a rate of 1.5ml / min. When adding the triethanolamine, keep the funnel outlet close to the surface of the emulsion to prevent air bubbles from forming during the addition process. Stir continuously while adding the triethanolamine. Continue stirring after the addition is complete until the pH of the system reaches 6.0. Then continue stirring for 10 minutes to ensure complete neutralization and pH stability.

[0028] S5, Activity Addition: Continue to allow the emulsion to cool naturally, monitoring the system temperature throughout. When the temperature drops to 38℃, slowly sprinkle the weighed Bosein along the stirring direction, maintaining the system temperature stable between 35 and 40℃ during the sprinkling process to avoid temperature fluctuations affecting the activity of Bosein. The stirring speed of Bosein is adjusted in stages: initially at 300 rpm for 5 minutes, then at 350 rpm for 10 minutes, and finally at 400 rpm for 5 minutes, until the Bosein is completely dissolved and the system is uniformly mixed without any lumps.

[0029] S6, Post-processing: The homogeneously mixed system is transferred to a filtration device and filtered using a 0.22μm sterile polyethersulfone membrane. The filtration pressure is strictly controlled at 0.25MPa. During filtration, any minute impurities and air bubbles that may be present in the system are removed to ensure a homogeneous and fine filtrate. After filtration, the filtrate is aseptically filled in a Class 100 clean area and immediately sealed to obtain a skin repair dressing containing PHOXY, such as... Figure 3 As shown. Example

[0030] Verification of the proportions of the core functional components in skin repair dressings.

[0031] Experimental Design: This embodiment verifies the effectiveness of the ratio range of BOXER and sodium hyaluronate. Four experimental groups were set up. Each group prepared skin repair dressings according to the complete preparation method of Example 1, only adjusting the weight parts of BOXER and sodium hyaluronate. The ratio of other raw materials and all process parameters in the preparation process were kept consistent with Example 1. The total weight parts of each component in all groups were 100 parts. The raw material preparation was exactly the same as the requirements of Example 1.

[0032] Experimental group 1: 0.8 parts of BOXER, 0.05 parts of sodium hyaluronate, and purified water was adjusted according to the ratio; Experimental Group 2: 1.2 parts of Bosein, 0.1 parts of sodium hyaluronate, and purified water adjusted according to the ratio; Experimental Group 3: 0.9 parts of Bosein, 0.06 parts of sodium hyaluronate, and purified water was adjusted according to the ratio. Experimental group 4: 1.1 parts of BOXER, 0.09 parts of sodium hyaluronate, and purified water was adjusted according to the ratio.

[0033] All skin repair dressings prepared in all groups were tested for three indicators: appearance, uniformity, and room temperature stability. Appearance was tested by visually observing the shape and state of the dressing. Uniformity was tested by using a laser particle size analyzer to determine the particle size distribution of the dressing and to determine whether there was any aggregation of large particles. Room temperature stability was tested by sealing the dressing in an environment of 25°C and 60% relative humidity for 30 days, and observing the appearance changes of the dressing on the 10th, 20th, and 30th days to determine whether phenomena such as layering, oil separation, and precipitation occurred.

[0034] Test results: Group Appearance Uniformity room temperature stability Experimental group 1 Milky white, fine emulsion, without layering or sedimentation. Uniform particle size distribution, with no large-diameter particles No significant changes were observed after 30 days of storage, and no oil separation or stratification was observed. Experimental group 2 Milky white, fine emulsion, without layering or sedimentation. Uniform particle size distribution, with no large-diameter particles No significant changes were observed after 30 days of storage, and no oil separation or stratification was observed. Experimental group 3 Milky white, fine emulsion, without layering or sedimentation. Uniform particle size distribution, with no large-diameter particles No significant changes were observed after 30 days of storage, and no oil separation or stratification was observed. Experimental group 4 Milky white, fine emulsion, without layering or sedimentation. Uniform particle size distribution, with no large-diameter particles No significant changes were observed after 30 days of storage, and no oil separation or stratification was observed. Results analysis: The above test results clearly show that when the amount of BOXER added is within the range of 0.8 to 1.2 parts and the amount of sodium hyaluronate added is within the range of 0.05 to 0.1 parts, the prepared skin repair dressing has a good appearance, is a uniform and delicate emulsion, and has excellent system homogeneity and uniform particle size distribution. It maintains good stability even after being placed at room temperature for 30 days, without any layering, oil separation, or precipitation. This ratio range represents the optimal ratio of BOXER and sodium hyaluronate, effectively ensuring the basic physicochemical properties of the skin repair dressing. Example

[0035] Verification of the oil phase composition and raw material sources of skin repair dressing.

[0036] Experimental Design: This embodiment double-verifies the weight ratio and raw material source of the core oil phase components, caprylic / capric triglyceride, cetyl ethylhexanoate, and squalane. The raw material preparation requirements are exactly the same as in Example 1. Four formulation experimental groups and three raw material source experimental groups were set up. All groups were prepared into skin repair dressings according to the preparation method of Example 1. In the formulation experimental groups, only the weight ratio of the three oil phase components was adjusted, while the ratios and process parameters of the other raw materials remained unchanged. In the raw material source experimental groups, only the source of a single oil phase raw material was changed, while the source, ratio, and process parameters of the other oil phase raw materials were consistent with those in Example 1.

[0037] Experimental group 1: Caprylic / capric triglyceride, cetyl ethylhexanoate, and squalane in a weight ratio of 1:0.9:0.5; Experimental group 2: Caprylic / capric triglyceride, cetyl ethylhexanoate, and squalane in a weight ratio of 1:1.1:0.7; Experimental group 3: Caprylic / capric triglyceride, cetyl ethylhexanoate, and squalane in a weight ratio of 1:1:0.5; Experimental group 4: Caprylic / capric triglyceride, cetyl ethylhexanoate, and squalane in a weight ratio of 1:1:0.7; Experimental Group 1: Caprylic / capric triglycerides were derived from chemical synthesis, and the remaining oil phase raw materials were the same as in Example 1; Experimental Group 2: Squalane was not derived from refined olive oil; the other oil phase raw materials were the same as in Example 1. Experimental group 3 for raw material sources: Cetyl ethylhexanoate is a non-synthetic grade raw material, and the remaining oil phase raw materials are the same as those in Example 1.

[0038] All skin repair dressings prepared in all groups were tested for three indicators: emulsification effect, skin feel, and high-temperature stability. The emulsification effect was tested by visual observation to see if the system achieved complete water-oil fusion and whether there was oil droplet precipitation. The skin feel was tested by measuring the viscosity of the dressing with a viscometer and combining it with manual coating test to judge the smoothness of the coating and whether there was a sticky or heavy feeling. The high-temperature stability test was conducted by sealing the dressing in a constant temperature environment of 45℃ for 15 days, and observing the changes in the appearance and emulsification state of the dressing on the 5th, 10th and 15th days.

[0039] Test results: Group Emulsification effect Skin feel High temperature stability Formula Experiment Group 1 Water and oil are completely mixed, with no oil droplets separating. The viscosity is moderate, and the coating is smooth and non-sticky. The emulsion stabilized after 15 days of storage, with no stratification. Formula Experiment Group 2 Water and oil are completely mixed, with no oil droplets separating. The viscosity is moderate, and the coating is smooth and non-sticky. The emulsion stabilized after 15 days of storage, with no stratification. Formula Experiment Group 3 Water and oil are completely mixed, with no oil droplets separating. The viscosity is moderate, and the coating is smooth and non-sticky. The emulsion stabilized after 15 days of storage, with no stratification. Formula Experiment Group 4 Water and oil are completely mixed, with no oil droplets separating. The viscosity is moderate, and the coating is smooth and non-sticky. The emulsion stabilized after 15 days of storage, with no stratification. Raw material source experimental group 1 Complete emulsification, with no oil droplets separating. The viscosity is relatively high, resulting in a thick coating. The emulsion stabilized after 15 days of storage, with no stratification. Raw material source experimental group 2 Complete emulsification, with no oil droplets separating. The viscosity is too high, and the coating feels sticky. The emulsion stabilized after 15 days of storage, with no stratification. Raw material source experimental group 3 Emulsification was mostly complete, with a small amount of oil droplets separating out. Uneven viscosity, grainy coating Crystallization occurred after 10 days, and stratification occurred after 15 days. Results analysis: The test results of the formulation experiment group showed that when the weight ratio of caprylic / capric triglyceride, cetyl ethylhexanoate, and squalane was in the range of 1:(0.9-1.1):(0.5-0.7), the oil phase component could achieve sufficient and good emulsification with the aqueous phase. The prepared dressing had excellent emulsification effect and could give the dressing moderate viscosity and good skin feel. It could also maintain a stable emulsification state under high temperature environment.

[0040] The results of raw material source verification showed that when caprylic / capric triglycerides were derived from coconut oil, cetyl ethylhexanoate was a synthetic-grade raw material, and squalane was derived from olive oil refining, the prepared skin repair dressing achieved optimal emulsification, skin feel, and high-temperature stability. Changing the source of any of the oil phase raw materials would lead to a deterioration in the skin feel of the dressing, and even problems such as poor emulsification and decreased high-temperature stability. Among them, the performance of the dressing decreased most significantly when cetyl ethylhexanoate was replaced with a non-synthetic-grade raw material. Example

[0041] Validation of Montanov L components and performance parameters.

[0042] Experimental Design: This embodiment verifies the validity of parameters such as the phytosterol content, cetyl alcohol content, and HLB value of Montanov L. The raw material preparation is exactly the same as that in Example 1. Four experimental groups were set up, and each group prepared skin repair dressings according to the complete preparation method in Example 1. Only the phytosterol content, cetyl alcohol content, and HLB value of Montanov L were adjusted. The other raw material ratios and all process parameters in the preparation process were kept consistent with those in Example 1.

[0043] Experimental group 1: Montanov L contained 40% phytosterols, 55% cetyl alcohol, and an HLB value of 8;

[0044] Experimental group 2: Montanov L contained 60% phytosterols, 40% cetyl alcohol, and an HLB value of 10;

[0045] Experimental group 3: Montanov L contained 45% phytosterols, 50% cetyl alcohol, and an HLB value of 8.5;

[0046] Experimental group 4: Montanov L contained 55% phytosterols, 45% cetyl alcohol, and an HLB value of 9.5.

[0047] All skin repair dressings prepared in all groups were tested for three indicators: centrifugal stability, pH stability, and low-temperature stability. For centrifugal stability testing, the dressings were placed in centrifuge tubes and centrifuged at 3000 r / min for 10 minutes. After centrifugation, the dressings were observed for phenomena such as layering and oil phase precipitation. For pH stability testing, the pH value of the system was measured on days 1, 7, 15, and 30 after the dressings were prepared, and the pH fluctuations were observed. For low-temperature stability testing, the dressings were sealed and placed in a -5℃ environment for 7 days. After 7 days, they were taken out and brought to room temperature. The appearance and changes in emulsification state of the dressings were observed to determine whether flocculent precipitation, layering, or other phenomena occurred.

[0048] Test results: Group Centrifugal stability pH stability Low temperature stability Experimental group 1 No stratification, stable emulsion state pH fluctuation ≤ 0.2 over 30 days No change was observed after returning to room temperature, and no flocculent precipitate was observed. Experimental group 2 No stratification, stable emulsion state pH fluctuation ≤ 0.2 over 30 days No change was observed after returning to room temperature, and no flocculent precipitate was observed. Experimental group 3 No stratification, stable emulsion state pH fluctuation ≤ 0.2 over 30 days No change was observed after returning to room temperature, and no flocculent precipitate was observed. Experimental group 4 No stratification, stable emulsion state pH fluctuation ≤ 0.2 over 30 days No change was observed after returning to room temperature, and no flocculent precipitate was observed. Results analysis: Experimental results show that when the phytosterol content in MontanovL is within the range of 40%-60%, the cetyl alcohol content is within the range of 40%-55%, and the HLB value is within the range of 8-10, the prepared skin repair dressing exhibits excellent centrifugal stability, pH stability, and low-temperature stability. MontanovL effectively stabilizes the overall emulsion system of the dressing, preventing stratification during centrifugation, while maintaining long-term pH stability. It also ensures the integrity of the emulsion system at low temperatures, without flocculent precipitation or stratification. This parameter range represents the optimal usage range for MontanovL, allowing it to fully exert its emulsion-stabilizing effect. Example

[0049] Optimization and validation of process parameters for preparing skin repair dressings.

[0050] Experimental Design: This embodiment focuses on single-factor optimization verification of the core process parameters in the dressing preparation process. The raw material preparation requirements are exactly the same as those in Example 1. Three core process parameters are selected: aqueous phase heat preservation temperature, homogenization emulsification speed, and Boswellia serrata addition temperature. Multiple level groups are set for each parameter. Each group prepares skin repair dressings according to the preparation method in Example 1. Only a single process parameter is adjusted, while the other process parameters and raw material ratios remain unchanged to ensure the single variable of the experiment.

[0051] Aqueous phase insulation temperature: Four levels of 75℃, 77℃, 78℃ and 80℃ were set to test the dissolution uniformity of the aqueous phase matrix at different temperatures, observe whether there are undissolved particles, and at the same time test the uniformity of the system after subsequent emulsification with the oil phase. Homogenization emulsification speed: Three levels of 1500 r / min, 1650 r / min and 1800 r / min were set to detect the uniformity of particle size distribution and the fineness of emulsion at different speeds; Pro-Xylane addition temperature: Four levels were set: 35℃, 37℃, 38℃ and 40℃. The dissolution effect of Pro-Xylane at different temperatures was tested, and it was observed whether there was clumping. At the same time, the retention rate of the active ingredients of Pro-Xylane after the dressing was placed for 30 days was tested.

[0052] Meanwhile, the rationality of process parameters such as anchor stirrer speed and water bath heating rate in aqueous phase preparation, oil phase injection rate and shear head insertion depth in homogenization emulsification, triethanolamine dripping rate in neutralization and cooling, and filtration pressure and cleanroom level in post-treatment were verified. By adjusting the parameters to deviate from the set range of Example 1, the effect of parameter changes on dressing preparation effect was observed.

[0053] Test results: process parameters test group detection indicators Test results Aqueous phase insulation temperature 75℃, 77℃, 78℃, 80℃ horizontal groups Aqueous phase dissolution uniformity The aqueous matrix was completely dissolved, with no undissolved particles. Homogenization Emulsification Speed 1500 r / min, 1650 r / min, 1800 r / min level groups Emulsion particle size and fineness Uniform particle size distribution, fine emulsification without oil droplets, and even finer particle size. Bosein temperature 35℃, 37℃, 38℃, 40℃ horizontal groups Bosein dissolution and activity retention Completely dissolves without clumping; activity retention rate ≥95% after 30 days. Results analysis: The horizontal group test results for each core process parameter were excellent. When the aqueous phase holding temperature was within the range of 75℃-80℃, the poorly soluble components such as carbomer and sodium hyaluronate in the aqueous phase could be completely dissolved to form a uniform aqueous matrix, providing a good foundation for subsequent full emulsification with the oil phase. When the homogenization emulsification speed was within the range of 1500r / min-1800r / min, efficient shearing and full mixing of the oil and aqueous phases could be achieved, resulting in finer emulsion particles, uniform distribution, and delicate emulsification without oil droplet precipitation or local oil phase aggregation. At the same time, this speed range would not cause a large number of bubbles to be generated in the system due to excessive speed, nor would it cause a sudden increase in local temperature that would damage the stability of the raw materials. When the addition temperature of Bosein was within the range of 35℃-40℃, it could ensure that Bosein could be quickly and completely dissolved without local agglomeration, and its active ingredients could be effectively preserved. After 30 days, the activity retention rate was still above 95%.

[0054] The verification results of the other process parameters show that the parameters set in Example 1, such as the anchor stirrer speed, water bath heating rate, and oil phase injection rate, can ensure the effect of each preparation step. If the parameters are adjusted beyond the set range, the physicochemical properties or component stability of the dressing will decrease to varying degrees, proving that the set of process parameters is the optimal preparation parameter for skin repair dressing. Example

[0055] Comprehensive testing of the physicochemical properties and long-term stability of skin repair dressings.

[0056] Experimental Design: This embodiment comprehensively tests the physicochemical properties and long-term stability of the skin repair dressing containing BPOXY prepared in Example 1. Simultaneously, dressings prepared from the four experimental groups in Example 2 are selected as parallel test groups. The raw material preparation is consistent with the requirements of Example 1. All tests are conducted with three parallel samples to eliminate experimental errors and ensure the accuracy and reliability of the test results. The test items include basic physicochemical properties, high-temperature stability, low-temperature stability, long-term stability at room temperature, and component compatibility. All tests are performed in a sterile environment, and environmental conditions such as temperature and humidity are strictly controlled during the testing process.

[0057] Test results: Testing items detection indicators Test results Basic physical and chemical properties Appearance All test samples were milky white, fine emulsions, without stratification, sedimentation, oil separation, or foreign matter. Basic physical and chemical properties pH value The pH values ​​of all test groups were within the range of 5.5 to 6.5, and the values ​​were stable. Basic physical and chemical properties viscosity The viscosity at 25℃ is between 10,000 and 20,000 mPa·s, indicating moderate viscosity. Basic physical and chemical properties Particle size distribution The particle size distribution is between 100 and 500 nm, and the distribution is uniform with no large particle aggregation. High temperature stability Store at a constant temperature of 45℃ for 90 days Observation was performed every 15 days. There were no changes in appearance, pH value, or viscosity, and the emulsion state remained stable. Low temperature stability Store at -10℃ for 90 days Observe every 15 days. After returning to room temperature, there is no freezing precipitation or flocculent material, and the physicochemical properties remain unchanged. Long-term stability at room temperature Store at 25℃ and 60% relative humidity for 12 months Tested every 3 months, with no changes in appearance, pH value, or viscosity, and a Bosein activity retention rate of ≥95%. Ingredient compatibility Content of each component and their interactions No chemical reaction occurred, the content of each component did not change significantly, and the compatibility was good. Results analysis: The comprehensive test results indicate that the skin repair dressing containing BOXER, prepared according to the raw material ratio and preparation method of this invention, exhibits excellent basic physicochemical properties. It is a homogeneous and fine emulsion with a suitable pH range, moderate viscosity, uniform particle size distribution, and no impurities or large particle aggregation. Under various environmental conditions, including high temperature, low temperature, and long-term storage at room temperature, the dressing maintains excellent stability. Even after 90 days or 12 months of storage, there are no significant changes in appearance, pH value, viscosity, or other physicochemical indicators. The emulsion system remains stable throughout, without stratification, oil separation, precipitation, or flocculent substances.

[0058] Meanwhile, the raw material components exhibit good compatibility, with no chemical reactions occurring during storage, and the content of each component remaining largely unchanged. The core active ingredient, BOXERIN, is stably retained for a long period, with an activity retention rate exceeding 95% after 12 months. These results fully demonstrate that the formulation design of this skin repair dressing is scientifically sound, and the preparation process parameters are precise and effective, ensuring the product possesses excellent physicochemical properties and long-term stability.

[0059] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A skin repair dressing containing styrofoam, characterized in that, The product comprises the following components by weight: 0.8-1.2 parts of Bosein, 0.05-0.1 parts of sodium hyaluronate, 6.0-10.0 parts of glycerol, 0.2-0.4 parts of carbomer, 0.8-1.2 parts of trehalose, 0.3-0.5 parts of p-hydroxyacetophenone, 4.0-6.0 parts of caprylic / capric triglyceride, 2.5-3.5 parts of Montanov L, 4.5-5.5 parts of cetyl ethylhexanoate, 2.5-3.5 parts of squalane, 0.8-1.2 parts of 1,2-hexanediol, and 0.2-0.4 parts of triethanolamine, with the balance being purified water. The total weight of all components is 100 parts.

2. The skin repair dressing containing phenolic resin according to claim 1, characterized in that, The sodium hyaluronate is composed of low molecular weight sodium hyaluronate and medium molecular weight sodium hyaluronate in a weight ratio of 7:

3. The molecular weight of the low molecular weight sodium hyaluronate is 1000-5000 Da, and the molecular weight of the medium molecular weight sodium hyaluronate is 10000-20000 Da.

3. The skin repair dressing containing phenolic resin according to claim 1, characterized in that, The weight ratio of caprylic / capric triglyceride, cetyl ethylhexanoate, and squalane is 1:(0.9-1.1):(0.5-0.7); wherein the caprylic / capric triglyceride is derived from coconut oil extraction, and the cetyl ethylhexanoate is a synthetic grade raw material.

4. A skin repair dressing containing phenolic resin according to claim 1, characterized in that, The MontanovL is a complex of phytosterol and cetyl alcohol. Based on the total weight of the complex, the content of phytosterol is 40%-60%, the content of cetyl alcohol is 40%-55%, and the HLB value of the complex is 8-10.

5. A method for preparing a skin repair dressing containing Proxylane, the method being applicable to the skin repair dressing containing Proxylane as described in any one of claims 1-4, characterized in that, The specific steps of this preparation method are as follows: S1, Aqueous phase preparation: Weigh out the prescribed amounts of sodium hyaluronate, glycerol, trehalose, carbomer, p-hydroxyacetophenone, 1,2-hexanediol and purified water, stir evenly and heat to 75-80℃, keep warm for 15-20 min to obtain the aqueous phase matrix. S2, Oil phase preparation: Weigh the prescribed amounts of caprylic / capric triglyceride, Montanov L, cetyl ethylhexanoate, and squalane, heat to 70-75℃, stir until completely melted and mixed evenly to obtain the oil phase matrix; S3, Homogenization and Emulsification: Maintain the temperature at 70-75℃, slowly add the oil phase matrix to the aqueous phase matrix, and homogenize and emulsify at a speed of 1500-1800r / min for 10-15min to form an emulsion; S4, Neutralization and Cooling: Stop heating and allow the emulsion to cool naturally to 45-50℃. Add the prescribed amount of triethanolamine and stir to neutralize until the pH of the system is 5.5-6.

5. Continue stirring for 10 minutes. S5, Active Addition: After the emulsion cools to 35-40℃, add the prescribed amount of BOXER and stir well; S6, Post-processing: The mixture is filtered and aseptically filled to obtain a skin repair dressing containing BOXEL.

6. The method for preparing a skin repair dressing containing phenolic resin according to claim 5, characterized in that, In step S1, the stirring is carried out using an anchor stirrer with an initial stirring speed of 300-400 r / min and continuous stirring for 5-8 min. The heating rate of the water bath is 5℃ / min, and the stirring is carried out at 200 r / min for 1 min every 3 min during the heat preservation period.

7. The method for preparing a skin repair dressing containing phenolic resin according to claim 5, characterized in that, In step S3, the oil phase matrix is ​​injected into the aqueous phase matrix through a sterile infusion pump at a rate of 5-10 ml / min, and the shear head of the high-speed shear homogenizer is inserted into the system to a depth of 1 / 2 below the liquid surface.

8. The method for preparing a skin repair dressing containing phenolic resin according to claim 5, characterized in that, In step S4, the natural cooling rate of the emulsion is 2-3℃ / min, and triethanolamine is added through a constant pressure dropping funnel at a dropping rate of 1-2ml / min, with the funnel outlet close to the liquid surface during the dropping process.

9. The method for preparing a skin repair dressing containing phenolic resin according to claim 5, characterized in that, In step S5, the bosine is slowly sprinkled in along the stirring direction, and the stirring speed is adjusted in stages: initially at 300 r / min for 5 min, in the middle stage at 350 r / min for 10 min, and in the later stage at 400 r / min for 5 min. The system temperature is maintained at 35-40℃ throughout the process.

10. A method for preparing a skin repair dressing containing phenolic resin according to claim 5, characterized in that, In step S6, the filtration uses a 0.22μm sterile filter membrane made of polyethersulfone, the filtration pressure is controlled at 0.2-0.3MPa, and the aseptic filling is carried out in a Class 100 clean area.

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