A moisturizing liquid dressing and method of making same

Abstract

The application discloses a moisturizing liquid dressing and a preparation method thereof. The dressing is composed of a macromolecular film-forming moisturizing agent, a protein active ingredient, an alcohol moisturizing agent, a sugar moisturizing agent, a pH regulator and the balance of water. The application can form a breathable protective film on the lip and facial wound surface, significantly promote the healing of a wet wound, and provide long-acting moisturization. The dressing is safe and non-irritating, has a refreshing skin feel, and meets the nursing needs of the skin with wounds such as cheilitis and post-medical beauty.

Description

Technical Field

[0001] This invention belongs to the fields of biomedicine, medical devices, and cosmetics, and particularly relates to a moisturizing liquid dressing and its preparation method. Background Technology

[0002] The skin is the most important immune defense line of the human body. As the thinnest and most sensitive area of ​​the face, the skin of the lips has no hair follicles or sebaceous glands, a thin stratum corneum, and few natural moisturizing factors. It loses moisture very quickly and is constantly exposed to the external environment and subjected to mechanical stimulation, making it extremely easy to be damaged and difficult to heal.

[0003] Skin wound care involves four stages: hemostasis, inflammation, proliferation, and remodeling. An ideal dressing should protect the wound, prevent infection, and provide a microenvironment conducive to healing. Traditional gauze dressings are prone to causing secondary damage; skin grafts are limited in availability, require high preservation conditions, are susceptible to pathogenic microorganisms, and are expensive, hindering their development; film dressings have poor absorbency and are only suitable for dry, superficial wounds, not for wounds with significant exudate. Hydrogel dressings have gained widespread attention due to their high water content, ability to maintain a moist environment, and promotion of granulation tissue growth. However, traditional hydrogel dressings often use small-molecule cross-linking agents such as aldehydes, whose residual cytotoxicity may affect healing outcomes. Most products currently on the market are designed for wounds on other parts of the body, posing risks of accidental ingestion, a sticky feel, and inconvenience, and lack specialized products for the unique physiological structure and care needs of the lips. While some cosmetics exist for daily care of healthy lips (such as CN116831947A), they are completely inadequate for the care needs of wounds such as those caused by cheilitis or post-cosmetic procedures.

[0004] Traditional ointment-type lip products, such as lip masks and lipsticks, involve manufacturing processes including heating, emulsification, and homogenization. The final step requires removing air bubbles introduced during emulsification. This process is energy-intensive, costly, and time-consuming, and cannot achieve truly sterile supply. Preservatives are often added, which can be bio-irritating. Therefore, traditional lipsticks cannot achieve the desired healing and moisturizing effects on lip wounds. Liquid dressings, compared to ointments, represent an upgrade from "high-energy-consumption, complex chemical processes" to "low-energy-consumption, simple physical processes." The process incorporates filtration and impurity removal before filling and reduces the dosage of final irradiation sterilization. Summary of the Invention

[0005] The purpose of this invention is to provide a moisturizing liquid dressing suitable for wounds on the lips, which can promote moist wound healing and provide long-lasting moisturizing effects, does not contain traditional cross-linking agents, is safe and non-irritating, enhances moisturizing without producing irritation or unpleasant sensations, and can effectively promote moist wound healing.

[0006] The technical solution adopted by this invention to solve the above-mentioned technical problems is a moisturizing liquid dressing, characterized by comprising the following components by weight: 0.1 to 1.5 parts of a macromolecular film-forming moisturizer; 0.05 to 0.4 parts of a protein-based active ingredient; 0.3 to 10.0 parts of an alcohol-based moisturizer; and 0.1 to 1.0 parts of a sugar-based moisturizer. The solution selects sodium polyglutamate as the macromolecular film-forming agent and defines a specific content range, combined with a specific compounding ratio of alcohol-based moisturizers, aiming to construct a specific matrix structure. This specific combination can achieve a balance between physical film formation and long-lasting moisturizing through the swelling of the film-forming agent and the compounding of the moisturizers, without the need for traditional cross-linking agents. Trehalose, as a sugar-based moisturizer, not only plays a moisturizing role in this system but may also protect the protein-based active ingredients, and this combination brings significant synergistic effects.

[0007] To optimize the above technical solution, the measures also include: a pH adjuster that adjusts the pH of the moisturizing liquid dressing to 5.5 to 6.5, and 80 to 110 parts of water.

[0008] The macromolecular film-forming moisturizer is sodium polyglutamate; the protein-based active ingredient is recombinant collagen. Preferably, the sodium polyglutamate is present in a weight ratio of 0.1 to 0.2 parts, and the recombinant collagen in a weight ratio of 0.6 to 0.8 parts. The formulation is specifically designed for delicate facial and lip skin, contains no traditional aldehyde cross-linking agents, avoids cytotoxicity, and has high safety. The gentle compounding of ingredients greatly reduces the risk of irritation. Sodium polyglutamate, together with sugars and alcohols, forms a complex moisturizing network that can form a breathable protective film on the lips, locking in moisture, reducing loss, and maintaining a moist environment on the wound surface for a long time, which is conducive to moist wound healing.

[0009] The alcohol-based moisturizer glycerin is compounded with polyethylene glycol, and the mass ratio of glycerin to polyethylene glycol is 20:1 to 50:1.

[0010] The trehalose humectant is present in a mass percentage of 0.1 to 0.5 parts.

[0011] The liquid formulation is lightweight and breathable, with a refreshing and non-sticky feel on the skin, avoiding the heaviness and discomfort of traditional ointments. It is easy to carry and reapply frequently, providing a good user experience. Furthermore, the dressing is in the form of a transparent liquid, essence, or flowable viscous liquid.

[0012] The present invention also provides a method for preparing a moisturizing liquid dressing, which includes the following steps: S1. Dissolve the alcohol-based humectant and sugar-based humectant in a portion of water and stir until homogeneous; S2. Add the macromolecular film-forming moisturizer to the aqueous phase obtained in step S1 and stir until completely dissolved; S3. After pre-dissolving the protein-based active ingredients, add them to the matrix from step S2 and gently stir to mix evenly; S4. Adjust the pH to 5.5-6.5 using a pH adjuster; S5. Add water to the required amount and stir well; S6. Filtration and impurity removal: The semi-finished product obtained in step S5 is filtered using a microporous filter membrane with a pore size of 0.22μm - 0.45μm; S7. Terminal Sterilization: The product filtered in step S6 is subjected to irradiation sterilization at a dose of 4 kGy to 8 kGy. Filtration using a microporous membrane reduces the initial microbial load of the product to below 1 CFU / mL. This method limits the irradiation dose to a narrow range of 4 kGy to 8 kGy, and the specific moisturizing liquid dressing formulation effectively promotes moist wound healing while being safe and non-irritating. Collagen dressings can achieve sterility assurance levels with a relatively low irradiation dose under the protection of the moisturizing liquid dressing components, and this method achieves effective sterilization and activity preservation at this dose through formulation optimization. Compared with traditional ointments and terminal sterilization technologies, the production process achieves low energy consumption, low cost, and low time consumption. The pre-sterilization filtration and impurity removal process reduces the irradiation dose, and the retention rate of active ingredients is greater than 95%. The aforementioned "partial water" refers to a portion of the total 80 to 110 parts of water, which can be any number of parts from 0.1 to 110. When the final volume is determined, the water will be added to bring the total volume to the required 80 to 110 parts. This is a common operational practice.

[0013] This invention also discloses the use of a moisturizing liquid dressing for the preparation of non-chronic wounds on the lips. The aforementioned non-chronic wounds include superficial wounds resulting from drying and cracking, postoperative sutured wounds, first-degree / superficial second-degree burns, any wound or combination thereof from postoperative incisions or wounds following surgical / plastic surgery.

[0014] Moisturizing liquid dressings can also be used to prepare chapped lip care products for ICU patients with routine use and non-chronic wounds.

[0015] Because this invention utilizes sodium polyglutamate combined with sugars and alcohols to form a composite moisturizing network, it can create a breathable protective film on the lips, locking in moisture and reducing loss. This solution maintains the active ingredients well even under low irradiation doses. Compared with existing technologies, this invention has the following significant advantages: 1. Highly targeted and safe: The formula is specially designed for delicate facial and lip skin, contains no traditional aldehyde cross-linking agents, avoids cytotoxicity, and is highly safe. The gentle ingredient combination greatly reduces the risk of irritation.

[0016] 2. Long-lasting moisturizing and film-forming protection: Sodium polyglutamate forms a complex moisturizing network with sugars and alcohols, which can form a breathable protective film on the lips, lock in moisture, reduce loss, and maintain a moist environment on the wound for a long time, which is conducive to moist wound healing.

[0017] 3. Excellent user experience: The liquid formulation is lightweight and breathable, leaving a refreshing and non-sticky feel on the skin. It avoids the heaviness and discomfort of traditional ointments, making it easy to carry and reapply frequently, resulting in a better user experience.

[0018] 4. Compared to traditional ointments and terminal sterilization technologies, the production process achieves low energy consumption, low cost, and low time consumption. The filtration and impurity removal process before sterilization reduces the irradiation dose, and the retention rate of active ingredients is greater than 95%.

[0019] 5. Filling a market gap: It pioneered the application of the concept of medical dressings to the lip field, accurately solving the care pain points of people with cheilitis, post-cosmetic surgery, etc., and filling a market gap. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the stimulation test location in an example of the effectiveness experiment of this invention; Figure 2 This is a schematic diagram of the skin sensitization test location in an experimental example of the efficacy of this invention; Figure 3 This is a VISA image showing the lip features after 2 hours, representing the effect of using the invention in Embodiment 1. Figure 4 The image shows the lip features after 4 hours, as an example of the effect of using this invention in Embodiment 1. Detailed Implementation

[0021] The present invention will be further described in detail below with reference to the accompanying embodiments.

[0022] The reference numerals are as follows: 1. Head end: 200 μL test substance injection point; 2. 200 μL 0.9% sodium chloride injection point; 3. Tail end; 4. 0.1 mL intradermal injection point; 5. Medial scapula area; 6.

[0023] Example 1: Moisturizing liquid dressing, comprising the following components by weight: 0.1 to 1.5 parts of macromolecular film-forming moisturizer; 0.05 to 0.4 parts of protein-based active ingredients; Alcohol-based moisturizers: 0.3 to 10.0 parts; 0.1 to 1.0 part of carbohydrate-based humectant; It also contains a pH adjuster to adjust the pH of the moisturizing liquid dressing to 5.5 to 6.5, and 80 to 110 parts of water; the macromolecular film-forming moisturizer is sodium polyglutamate; and the protein active ingredient is recombinant collagen.

[0024] The proposed solution uses sodium polyglutamate as a macromolecular film-forming agent with a defined content range, combined with a specific blending ratio of alcohol-based humectants, to construct a specific matrix structure. This particular combination may be intended to achieve a balance between physical film formation and long-lasting hydration through the swelling of the film-forming agent and the blending of humectants, without the use of traditional cross-linking agents. Trehalose, as a sugar-based humectant, not only plays a moisturizing role in this system but may also protect protein-based active ingredients, and this combination results in a significant synergistic effect.

[0025] As a preferred formulation, the sodium polyglutamate is present in a weight ratio of 0.1 to 0.2 parts, and the recombinant collagen is preferably present in a weight ratio of 0.6 to 0.8 parts. This formulation is specifically designed for delicate facial and lip skin, contains no traditional aldehyde cross-linking agents, avoids cytotoxicity, and has high safety. As a preferred method, vitamin B6 (0.01 to 0.5 parts) can also be added as an adjuvant to the macromolecular film-forming moisturizer, as discussed in subsequent examples. The complex formulation is gentle, greatly reducing the risk of irritation. Sodium polyglutamate, together with sugars and alcohols, forms a complex moisturizing network that can form a breathable protective film on the lips, locking in moisture, reducing loss, and maintaining a moist environment on the wound surface for a long time, which is conducive to moist wound healing.

[0026] The alcohol-based moisturizer glycerin is compounded with polyethylene glycol, and the mass ratio of glycerin to polyethylene glycol is (20:1) to (50:1).

[0027] The trehalose, a sugar-based moisturizer, comprises 0.1-0.5% by weight. The liquid formulation is lightweight and breathable, providing a refreshing and non-sticky feel, avoiding the heaviness and discomfort of traditional ointments. It is easy to carry and reapply frequently, offering a superior user experience. Furthermore, the dressing is in the form of a transparent liquid, serum, or a flowable viscous liquid.

[0028] A method for preparing the above-mentioned moisturizing liquid dressing includes the following steps: S1. Dissolve the alcohol-based humectant and sugar-based humectant in a portion of water and stir until homogeneous; S2. Add the macromolecular film-forming moisturizer to the aqueous phase obtained in step S1 and stir until completely dissolved; S3. After pre-dissolving the protein-based active ingredients, add them to the matrix from step S2 and gently stir to mix evenly; S4. Adjust the pH to 5.5-6.5 using a pH adjuster; S5. Add water to the required amount and stir well; S6. Filtration and impurity removal: The semi-finished product obtained in step S5 is filtered using a microporous filter membrane with a pore size of 0.22μm - 0.45μm; S7. Terminal Sterilization: The product filtered in step S6 is subjected to irradiation sterilization at a dose of 4 kGy to 8 kGy. Filtration using a microporous membrane reduces the initial microbial load of the product to below 1 CFU / mL. This method limits the irradiation dose to a narrow range of 4 kGy to 8 kGy, and the specific moisturizing liquid dressing formulation effectively promotes moist wound healing while being safe and non-irritating. Collagen dressings can achieve sterility assurance levels with a relatively low irradiation dose under the protection of the moisturizing liquid dressing components, and this method achieves effective sterilization and activity preservation at this dose through formulation optimization. Compared with traditional ointments and terminal sterilization technologies, the production process achieves low energy consumption, low cost, and low time consumption. The pre-sterilization filtration and impurity removal process reduces the irradiation dose, and the retention rate of active ingredients is greater than 95%. The aforementioned "partial water" refers to a portion of the total 80 to 110 parts of water, which can be any number of parts from 0.1 to 110. When the final volume is determined, the water will be added to bring the total volume to the required 80 to 110 parts. This is common knowledge for those skilled in the art and will not be elaborated further below.

[0029] This embodiment provides the following specific preferred implementation method: A sterile liquid lip care dressing, comprising the following components: Sodium polyglutamate 1.00% Recombinant collagen 0.1% Glycerin 7.0% Trehalose 0.4% 0.2% polyethylene glycol Apply an appropriate amount of pH adjuster (to adjust the pH to 6.0). Add water to 100% Preparation method: Weigh out glycerin, polyethylene glycol, and trehalose, add them to approximately 80% deionized water, and stir until completely dissolved.

[0030] Polyglutamic acid was slowly added to the above solution while stirring continuously for 2 hours to ensure complete dissolution, resulting in a transparent gel matrix.

[0031] After pre-dissolving the recombinant collagen in the remaining 10% of the water, slowly add it to the above matrix and gently stir at low speed for 30 minutes to avoid generating too many bubbles and ensure that it is mixed evenly.

[0032] Adjust the pH of the system to 6.0 using a small amount of pH adjuster.

[0033] Add deionized water to 100% and stir well. Here, adding water to 100% means the total mass is 100 parts. All solutes are converted using equivalent methods: 1.00% sodium polyglutamate is considered 1 part, 0.1% recombinant collagen is considered 0.1 part, 7.0% glycerol is considered 7 parts, 0.4% trehalose is considered 0.4 parts, and 0.2% polyethylene glycol is considered 0.2 parts. pH adjuster is added according to its actual weight. Finally, add deionized water to bring the total to 100 parts. This is a standard chemical procedure description and will not be elaborated further below.

[0034] Filtration and impurity removal: The above-mentioned liquid was filtered under pressure using a polyethersulfone (PES) microporous filter membrane with a pore size of 0.22 μm to remove impurities and significantly reduce the microbial load.

[0035] Terminal sterilization: The filtered clarified solution was aseptically dispensed into vials and sterilized by gamma irradiation using a cobalt-60 source at a dose of 6 kGy. Testing showed that the product's sterility assurance level (SAL) reached 10⁻. 6 Furthermore, the retention rate of heat-sensitive active ingredients such as recombinant collagen is greater than 95%.

[0036] Example 2: A sterile liquid lip care dressing, comprising the following components: Sodium polyglutamate 1.00% Glycerin 7.0% Trehalose 0.4% 0.2% polyethylene glycol Apply an appropriate amount of pH adjuster (to adjust the pH to 6.0). Add water to 100% Preparation method: Weigh out glycerin, polyethylene glycol, and trehalose, add them to approximately 80% deionized water, and stir until completely dissolved.

[0037] Polyglutamic acid was slowly added to the above solution while stirring continuously for 2 hours to ensure complete dissolution, resulting in a transparent gel matrix.

[0038] Adjust the pH of the system to 6.0 using a small amount of pH adjuster.

[0039] Add deionized water to 100% and stir well.

[0040] Filtration and impurity removal: The above-mentioned liquid was filtered under pressure using a polyethersulfone (PES) microporous filter membrane with a pore size of 0.22 μm to remove impurities and significantly reduce the microbial load.

[0041] Terminal sterilization: The filtered clarified solution was aseptically dispensed into vials and sterilized by gamma irradiation using a cobalt-60 source at a dose of 6 kGy. Testing showed that the product's sterility assurance level (SAL) reached 10⁻. 6 Furthermore, the retention rate of heat-sensitive active ingredients such as recombinant collagen is greater than 95%.

[0042] Example 3: A sterile liquid lip care dressing, comprising the following components: Sodium polyglutamate 0.6% Glycerin 7.0% Trehalose 0.4% Polyethylene glycol 0.4% Apply an appropriate amount of pH adjuster (to adjust the pH to 6.0). Add water to 100% Preparation method: Weigh out glycerin, polyethylene glycol, and trehalose, add them to approximately 80% deionized water, and stir until completely dissolved.

[0043] Polyglutamic acid was slowly added to the above solution while stirring continuously for 2 hours to ensure complete dissolution, resulting in a transparent gel matrix.

[0044] Adjust the pH of the system to 6.0 using a small amount of pH adjuster.

[0045] Add deionized water to 100% and stir well.

[0046] Filtration and impurity removal: The above-mentioned liquid was filtered under pressure using a polyethersulfone (PES) microporous filter membrane with a pore size of 0.22 μm to remove impurities and significantly reduce the microbial load.

[0047] Terminal sterilization: The filtered clarified solution was aseptically dispensed into vials and sterilized by gamma irradiation using a cobalt-60 source at a dose of 6 kGy. Testing showed that the product's sterility assurance level (SAL) reached 10⁻. 6 Furthermore, the retention rate of heat-sensitive active ingredients such as recombinant collagen is greater than 95%.

[0048] Example 4: Sodium polyglutamate 1.00% Vitamin B6 0.02% Recombinant collagen 0.1% Glycerin 7.0% 0.2% polyethylene glycol Trehalose 0.4% Apply an appropriate amount of pH adjuster (to adjust the pH to 6.0). Add water to 100% Preparation method: Weigh out glycerin, polyethylene glycol, and trehalose, add them to approximately 80% deionized water, and stir until completely dissolved.

[0049] Polyglutamic acid and vitamin B6 were slowly added to the above solution while stirring continuously for 2 hours to ensure complete dissolution, resulting in a transparent gel matrix.

[0050] After pre-dissolving the recombinant collagen in the remaining 10% of the water, slowly add it to the above matrix and gently stir at low speed for 30 minutes to avoid generating too many bubbles and ensure that it is mixed evenly.

[0051] Adjust the pH of the system to 6.0 using a small amount of pH adjuster.

[0052] Add deionized water to 100% and stir well.

[0053] Filtration and impurity removal: The above-mentioned liquid was filtered under pressure using a polyethersulfone (PES) microporous filter membrane with a pore size of 0.22 μm to remove impurities and significantly reduce the microbial load.

[0054] Terminal sterilization: The filtered clarified solution was aseptically dispensed into vials and sterilized by gamma irradiation using a cobalt-60 source at a dose of 6 kGy. Testing showed that the product's sterility assurance level (SAL) reached 10⁻. 6 Furthermore, the retention rate of heat-sensitive active ingredients such as recombinant collagen is greater than 95%.

[0055] Comparative Example 1: A sterile liquid lip care dressing, comprising the following components: Recombinant collagen 0.4% Phenoxyethanol 0.4% Sodium methylparaben 0.1% 8% glycerin Sodium propylparaben 0.1% Add PBS buffer to 100%. Preparation method: ① Weigh out glycerol and add it to approximately 80% PBS buffer, then stir until completely dissolved.

[0056] ② After pre-dissolving the recombinant collagen in the remaining 10% PBS buffer, slowly add it to the above matrix and gently stir at low speed for 30 minutes to avoid generating too many bubbles and ensure that it is mixed evenly.

[0057] ③ Slowly add phenoxyethanol, sodium methylparaben, and sodium propylparaben to the above solution while stirring continuously for 2 hours until fully dissolved.

[0058] ④ Add PBS buffer to 100% and stir well.

[0059] ⑤ Filtration and impurity removal: The above-mentioned liquid was filtered under pressure using a polyethersulfone (PES) microporous filter membrane with a pore size of 0.22 μm to remove impurities and significantly reduce the microbial load.

[0060] Terminal sterilization: The filtered clarified solution was aseptically dispensed into vials and sterilized by gamma irradiation using a cobalt-60 source at a dose of 6 kGy. Testing showed that the product's sterility assurance level (SAL) reached 10⁻. 6 Furthermore, the retention rate of heat-sensitive active ingredients such as recombinant collagen is greater than 95%.

[0061] Comparative Example 2: A sterile liquid lip care dressing, comprising the following components: Sodium hyaluronate 0.20% Recombinant collagen 0.20% Sodium polyglutamate 0.20% Glycerin 3.00% Trehalose 0.40% Polyethylene glycol-8 0.40% Ectocin 0.20% Methyl glucose polyether-20 0.20% Phenoxyethanol 0.8% Add water to 100% Preparation method: ① Weigh out glycerin, polyethylene glycol, trehalose, ecoxib, methyl glucose polyether-20, and phenoxyethanol, add them to about 80% deionized water, and stir until completely dissolved.

[0062] ② Slowly add sodium hyaluronate and sodium polyglutamate to the above solution while stirring. Continue stirring for 2 hours to ensure complete dissolution and obtain a transparent gel matrix.

[0063] ③ After pre-dissolving the recombinant collagen in the remaining 10% of the water, slowly add it to the above matrix and gently stir at low speed for 30 minutes to avoid generating too many bubbles and ensure that it is mixed evenly.

[0064] ④ Add deionized water to 100% and stir well.

[0065] ⑤ Filtration and impurity removal: The above-mentioned liquid was filtered under pressure using a polyethersulfone (PES) microporous filter membrane with a pore size of 0.22 μm to remove impurities and significantly reduce the microbial load.

[0066] Terminal sterilization: The filtered clarified solution was aseptically dispensed into vials and sterilized by gamma irradiation using a cobalt-60 source at a dose of 6 kGy. Testing showed that the product's sterility assurance level (SAL) reached 10⁻.6 Furthermore, the retention rate of heat-sensitive active ingredients such as recombinant collagen is greater than 95%.

[0067] Effect Experiment Example: The cytotoxicity test was conducted in accordance with GB / T 16886.5-2017 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Test Methods. 1) Experimental materials L929 cells, MEM medium, PBS, D-Hanks buffer, isopropanol, 0.25% trypsin solution and fetal bovine serum (FBS), 0.25% trypsin (containing EDTA), DMSO, and MTT assay kit. The experimental groups were selected from Examples 1-3 and Comparative Examples 1-2, respectively, with drugs added at 2 mg / mL, and blank control. 2) Experimental Procedure ① Digest the cultured L929 cells with 0.25% trypsin solution to prepare a cell suspension, and adjust the cell concentration to 1×10⁻⁶. 5 per mL.

[0068] ② The prepared cell suspension was seeded into a 96-well plate. According to different groups, there were 6 replicates per group, and 100 μL of cell suspension was seeded into each well.

[0069] ③ Place the 96-well plate in a CO2 incubator at 37°C and 5% CO2 for 24 hours. After 24 hours, discard the culture medium, add different sample groups, and place them in a CO2 incubator at 37°C and 5% CO2 for 24 hours.

[0070] ④ Discard the sample and control solutions, add 50 μL of MTT (1 mg / mL) solution to each well, and continue to incubate in a carbon dioxide incubator at 37°C with 5% CO2 for 2 h. Discard the MTT solution, add 100 μL of isopropanol to each well, and incubate in a shaker at 37°C with 60 rpm for 30 min.

[0071] ⑤ Measure the absorbance at a wavelength of 570 nm using an ELISA reader (reference wavelength 650 nm).

[0072] ⑥ Data analysis: Cell viability (%) = 100 * (OD570e / OD570b) In the formula: OD570e: Average optical density of 100% extract of the test sample; OD570b: Average optical density of blank sample; If cell viability drops to less than 70% of the control, it has potential cytotoxicity. 4) The test results are shown in Table 1. Table 1: Cytotoxicity data of the examples and comparative samples at 2 mg / mL

[0073] The intradermal reaction test was conducted according to the methods outlined in GB / T 16886.23-2023 "Biological Evaluation of Medical Devices - Part 23: Stimulation Testing". The sample from Example 1 was administered to New Zealand rabbits via intradermal injection to assess the potential for a stimulating response under the test conditions. Experimental steps: ① Animal preparation: Three New Zealand rabbits were tagged, weighed and quarantined, and pre-fed in the laboratory's general environmental animal room for three days to acclimatize to the laboratory environment.

[0074] ② Animal preparation: 18 hours before the experiment, remove enough fur (about 10cm × 20cm) from both sides of the spine on the back of the New Zealand rabbit as the test and observation site.

[0075] ③ Contact Procedure: Five injection points were made on the upper left side of the spine of New Zealand rabbits, with 200 μL of the test sample stock solution injected at each point. Five injection points were made on the upper right side of the spine of New Zealand rabbits, with 200 μL of 0.9% sodium chloride injection solution injected at each point as a control. The procedure was followed as per the attached instructions. Figure 1 As shown.

[0076] ④ Symptom observation: Immediately after injection, and at (24±2)h, (48±2)h and (72±2)h, the condition of each injection site was observed and recorded. The tissue reaction of erythema and edema at each injection site was scored according to the scoring system given in Table 2 for each observation period, and the test results were recorded.

[0077] Table 2 Intradermal Response Scoring System

[0078] ⑤ Test Results Under the experimental conditions, the final score for the intradermal reaction of the sample in Example 1 was 0.00. The scoring results are shown in Table 3.

[0079] Table 3 Recording Table of Intradermal Reaction Test Results

[0080] The final score of the intradermal reaction of the test sample was no greater than 1.0, which meets the test requirements.

[0081] The acute systemic toxicity test was conducted according to the systemic toxicity test requirements recommended in GB / T 16886.11-2021 "Biological Evaluation of Medical Devices Part 11: Systemic Toxicity Testing". KM mice were used to evaluate the likelihood of the test sample from Example 1 causing potential acute systemic toxicity under the test conditions. Test procedure: ① Animal preparation: Mice were pre-housed in the laboratory barrier environment animal room for 6 days to acclimatize to the laboratory environment. Before the experiment, 10 quarantine-qualified mice were stained and labeled and divided into two groups: the experimental group and the control group, with 5 mice in each group.

[0082] ② Experimental procedure: Before contact with the test sample stock solution, KM mice were weighed. The experimental group animals were given the test sample by subcutaneous injection, while the control group was given sodium chloride injection in the same way. The contact volume was 50 mL / kg according to the requirements of Table B.1 of Appendix B of GB / T 16886.11-2021 for the maximum single dose volume of test sample contact. After the contact was completed, the KM mice were returned to their respective mouse boxes for rearing.

[0083] ③ Symptom observation: After exposure to the test sample solution, each KM mouse was carefully and comprehensively observed. Observation, weighing, and recording were performed daily for three consecutive days. The body weight of the mice after exposure to the test sample solution was recorded to observe the effect of the test sample on body weight. If clinical signs appeared during the experiment, a gross pathological evaluation was required.

[0084] ④ Evaluation Regulations (1) During the observation period of acute systemic toxicity test, if the biological response of the animals exposed to the test sample is not greater than that of the animals in the control group, the test sample meets the test requirements.

[0085] (2) Five animals are used. If two or more animals die, or two or more animals convulse or lie prone, or three or more animals lose more than 10% of their weight, the test sample does not meet the test requirements.

[0086] (3) If the experimental group animals only show mild biological reactions and no more than one animal shows general biological reaction symptoms or dies, the experiment should be repeated with 10 animals as the experimental group.

[0087] (4) If, during repeated experiments, all 10 animals that came into contact with the test sample showed no biological response of greater scientific significance than that of the control group animals during the observation phase, then the test sample meets the experimental requirements.

[0088] ⑤ No symptoms of death or systemic toxicity in the animals were observed due to the test sample, and there were no significant abnormalities in the body weight of the animals in the experimental and control groups. See Tables 4 and 5 for details.

[0089] Table 4 Animal mortality and weight data

[0090] Table 5. Results of animal mortality, clinical observation, and weight loss.

[0091] Under the conditions of this test, the test sample did not cause any acute systemic toxicity, and the sample has no potential acute systemic toxicity.

[0092] The skin sensitization test was conducted according to the maximum dose method recommended in section 6.5 of GB / T 16886.10-2024 "Biological Evaluation of Medical Devices - Part 10: Skin Sensitization Tests" for guinea pig skin sensitization testing. The potential of the test sample from Example 1 to induce a skin sensitization reaction in guinea pigs under the test conditions was assessed. The test locations are as follows... Figure 2 As shown.

[0093] ① Animal preparation: Guinea pigs were pre-housed in the laboratory animal room for 5 days to acclimatize to the laboratory environment. Fifteen quarantine-qualified guinea pigs were stained and marked, and randomly divided into experimental and control groups according to their weight, with 10 guinea pigs in each experimental group and 5 guinea pigs in each control group. Before the experiment, the fur near the scapula on the back of the guinea pigs was removed, covering an area of ​​3cm × 3cm.

[0094] ② Intradermal induction phase: As shown in the figure below, inject 0.1 mL intradermally in pairs into the medial part of the scapula of each guinea pig after hair removal.

[0095] Site A: Both the experimental and control groups were injected with a stable emulsifier consisting of Freund's complete adjuvant and the corresponding solvent at a volume ratio of 50:50.

[0096] Site B: The test group was injected with the test substance; the control group was injected with the corresponding solvent.

[0097] Site C: The test group was injected with a stable emulsifier prepared by mixing the test substance with Freund's complete adjuvant and solvent (the solution used in Site A) in a 50:50 volume ratio; the control group was injected with an emulsifier of adjuvant and blank solution.

[0098] ③ Surface induction stage A stimulating response was generated during the intradermal induction phase. Seven days later, at the concentration selected at site B during the intradermal induction phase, an area of ​​approximately 8 cm² was treated. 2 Absorbent gauze was applied topically to the medial aspect of the scapula of each guinea pig, covering the intradermal injection site. The absorbent gauze was secured with a closed bandage and removed after (48±2) h. The control group guinea pigs underwent the same procedure with the corresponding blank solution.

[0099] ④ Stimulation Phase Thirteen days after the surface induction phase, absorbent gauze was soaked in the test substance or corresponding solvent at the concentration selected in site B of the intradermal induction phase and applied topically to the upper abdomen of the animal that was not tested during the induction phase. It was secured with a closed bandage and the bandage and absorbent gauze were removed after (24±2) h.

[0100] ⑤ Symptom observation Skin conditions at the stimulation sites in guinea pigs of the experimental and control groups were observed at (24±2) h and (48±2) h after the patch was removed, according to the Magnusson and Kligman grading criteria given in Table 6. The grading criteria described and graded the skin erythema and edema reactions at each stimulation site and at each observation time.

[0101] Table 6 Magnusson and Kligman Grading Criteria

[0102] ① Experimental Results Under the conditions of this experiment, the test samples did not induce skin sensitization. The skin reaction results and clinical observations in guinea pigs are shown in Table 7. Under the conditions of this experiment, the test samples did not induce skin sensitization, and the incidence of positive challenge results was 0%. Figure 3 , Figure 4 Comparative images of the lip skin condition (dryness, peeling, cracking) of volunteers before and after using the dressing of this invention at different times. The images clearly demonstrate the superior healing effect.

[0103]

[0104] A sensory evaluation questionnaire was used to select 30 people with dry lips, and sensory evaluation scores were given for the example and comparative examples.

[0105] Table 8 Sensory Evaluation Indicators

[0106]

[0107]

[0108] The average scores of the four samples are as follows. According to the statistical results, Example 1 has the best overall evaluation, which is better than Comparative Example 1.

[0109] Table 9. Statistical Table of Overall Average Sensory Evaluation Score

[0110] The embodiments of the present invention are all superior to the comparative examples.

[0111] Twenty volunteers with dry, flaky lips were recruited for a stratum corneum moisture content test and randomly divided into four groups: a blank control group, and Examples 1, 2, 3, and 4. The stratum corneum moisture content of the lips was measured using a skin moisture meter before product application and at 2, 4, and 8 hours after application. The average results showed that the product group exhibited significantly better moisture content increase and persistence at all time points than the blank control group. Examples 1 and 4 showed significantly better results; the synergist vitamin B6 worked synergistically with the basic formulation to protect the active ingredients, resulting in a better enhanced moisturizing effect. Given that the skin on the lips lacks sebaceous glands, traditional moisturizers only provide temporary hydration. This invention, by introducing vitamin B6, provides immediate hydration while inducing local lipid synthesis on the lips, rebuilding the physiological moisture-locking film, and addressing the clinical pain point of easily dry and cracked lips.

[0112] Table 10 Statistical Table of Stratum Corneum Moisture Content Test

[0113] Although the invention has been described in conjunction with preferred embodiments, it is not intended to limit the invention. Any person skilled in the art can make various changes, substitutions and modifications to the subject matter listed herein without departing from the spirit and scope of the invention. Therefore, the scope of protection of the invention shall be determined by the scope defined in the claims.

Claims

1. A moisturizing liquid dressing, characterized in that, The following components are included in parts by weight: 0.1 to 1.5 parts of macromolecular film-forming moisturizer; 0.05 to 0.4 parts of protein-based active ingredients; Alcohol-based moisturizers: 0.3 to 10.0 parts; 0.1 to 1.0 parts of sugar-based humectant.

2. The moisturizing liquid dressing according to claim 1, characterized in that: It also contains a pH adjuster to adjust the pH of the moisturizing liquid dressing to 5.5 to 6.5, and 80 to 110 parts of water.

3. The moisturizing liquid dressing according to claim 1, characterized in that: The macromolecular film-forming moisturizer is sodium polyglutamate; the protein-based active ingredient is recombinant collagen.

4. The moisturizing liquid dressing according to claim 1, characterized in that: The alcohol-based moisturizer glycerin is compounded with polyethylene glycol, and the mass ratio of glycerin to polyethylene glycol is 20:1 to 50:

1.

5. The moisturizing liquid dressing according to claim 1, characterized in that: The trehalose humectant is present in a mass percentage of 0.1 to 0.5 parts.

6. A method for preparing the moisturizing liquid dressing of claim 1, characterized in that: Includes the following steps: S1. Dissolve the alcohol-based humectant and sugar-based humectant in a portion of water and stir until homogeneous; S2. Add the macromolecular film-forming moisturizer to the aqueous phase obtained in step S1 and stir until completely dissolved; S3. After pre-dissolving the protein-based active ingredients, add them to the matrix from step S2 and gently stir to mix evenly; S4. Adjust the pH to 5.5-6.5 using a pH adjuster; S5. Add water to the required amount and stir well; S6. Filtration and impurity removal: The semi-finished product obtained in step S5 is filtered using a microporous filter membrane with a pore size of 0.22μm - 0.45μm; S7. Terminal sterilization: The product filtered in step S6 is subjected to irradiation sterilization, wherein the irradiation sterilization dose is 4 kGy to 8 kGy.

7. The use of the moisturizing liquid dressing according to claim 1 for the preparation of non-chronic wound treatments for the lips.

8. The use according to claim 7, characterized in that: The non-chronic wounds mentioned include any or a combination of the following: superficial wounds resulting from drying and cracking, postoperative sutured wounds, first-degree / superficial second-degree burns, and postoperative incisions or wounds from surgical / plastic surgery.

9. The use of the moisturizing liquid dressing according to claim 1 in the preparation of a chapped lip care product for ICU patients with routine use and non-chronic wounds.

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