Moisturizing and repairing medical spray containing glycosylglycerol and preparation method of moisturizing and repairing medical spray

Abstract

The invention relates to a moisturizing and repairing medical spray containing glycosylglycerol and a preparation method of the moisturizing and repairing medical spray. The anti-inflammatory and anti-inflammatory gel is prepared from the following components: 0.5%-2% of glycosylglycerol (wherein the mass ratio of 2-beta GG to 2-alpha GG is 0.08: 1), 0.01%-0.5% of recombinant humanized III-type collagen, 0.3%-0.7% of trehalose, 0.05%-0.3% of beta-glucan (wherein the molecular weight ratio is specific), 3%-10% of a humectant, 0.1%-1% of a soothing anti-inflammatory agent, 0.01%-0.5% of a pH regulator, 0.01%-0.3% of a preservative and the balance of deionized water. Wherein the four active components meet a specific relational expression. The invention also provides a preparation method and application of the medical spray. According to the medical spray disclosed by the invention, through the specific proportion and synergistic matching of the active ingredients, excellent moisturizing performance, barrier repairing function, wound healing activity and soothing and anti-inflammatory effects are realized, and the medical spray is high in safety, good in use experience and suitable for nursing of various skin types, particularly sensitive skin and damaged skin.

Description

Technical Field

[0001] This invention relates to the field of medical skin care preparation technology, and in particular to a moisturizing and repairing medical spray containing glyceryl glucoside and its preparation method. Background Technology

[0002] Skin barrier damage is a common pathological basis for many skin problems. In daily life, the skin is often affected by external stimuli (such as ultraviolet rays and chemicals), cosmetic treatments (such as lasers and microneedling), and diseases (such as dermatitis and eczema), leading to impaired skin barrier function and problems such as dryness, roughness, redness, and itching. Therefore, the development of medical sprays with highly effective moisturizing and repairing functions has significant clinical significance and application value.

[0003] Currently, moisturizing and repairing products on the market have the following shortcomings: First, their moisturizing effect is not long-lasting, and they cannot achieve both immediate moisturizing and long-lasting water retention at the same time; second, their repair function is limited, and they cannot simultaneously address barrier repair and anti-inflammatory soothing; third, their user experience is poor, with most products having issues such as stickiness and residue; and fourth, their safety is insufficient, and they may irritate damaged and sensitive skin.

[0004] Glyceryl glucoside (GG) is a compound composed of glycerol and glucose linked by a glycosidic bond, possessing excellent moisturizing properties and cell-protective effects. Studies have shown that glyceryl glucoside can enhance the cell's resistance to dryness and promote the synthesis of hyaluronic acid, thereby exerting a moisturizing effect. However, the application of glyceryl glucoside in current technologies has limitations, such as limited effectiveness when used alone, requiring combination with other ingredients to achieve optimal results, but optimized formulation designs are currently lacking.

[0005] There are already some relevant solutions in the existing technology: For example, Chinese invention patent application CN115227608A discloses a repair and moisturizing spray containing ingredients such as glyceryl glucoside, ceramide, and trehalose. However, this solution uses ceramide as the main repair ingredient and does not involve the synergistic combination of recombinant humanized collagen with a specific ratio of glyceryl glucoside and β-glucan.

[0006] For example, Chinese invention patent application CN115944559A discloses a polysaccharide composition comprising biological polysaccharide, β-glucan and glycerol glucoside. It mentions a specific configuration ratio of glycerol glucoside (2-βGG to 2-αGG ratio of 0.08:1) and a molecular weight combination of β-glucan. However, this scheme mainly focuses on the polysaccharide composition and does not involve the synergistic use with recombinant humanized collagen.

[0007] For example, Chinese invention patent CN114224768A discloses a repair and anti-aging composition containing glyceryl glucoside and recombinant human collagen. However, the content of recombinant collagen in this solution is extremely low (0.03%-0.15%), and it does not involve the specific combination relationship between trehalose and β-glucan.

[0008] Based on the above technical problems, this invention has developed a moisturizing and repairing medical spray containing glyceryl glucoside through extensive experimental research. By scientifically formulating and optimizing the process of active ingredients such as glyceryl glucoside, recombinant collagen, trehalose and β-glucan, synergistic effects are achieved, resulting in excellent moisturizing and repairing effects as well as good safety and user experience. Summary of the Invention

[0009] To address the shortcomings of existing technologies, the present invention aims to provide a moisturizing and repairing medical spray containing glyceryl glucoside and its preparation method, thereby solving the technical problems of existing moisturizing and repairing products having limited functionality, insufficient durability, and poor user experience.

[0010] Another object of the present invention is to provide a method for preparing the above-mentioned medical spray, ensuring product stability, safety and bioactivity of active ingredients.

[0011] Another object of the present invention is to provide the application of the medical spray in skin moisturizing, barrier repair, wound healing and soothing and anti-inflammatory effects.

[0012] The above-mentioned objective of this invention is achieved through the following technical solutions: A moisturizing and repairing medical spray containing glyceryl glucoside, comprising the following components by weight percentage: Glyceryl glucoside 0.5%-2%, wherein the mass ratio of 2-β-glyceryl glucoside to 2-α-glyceryl glucoside is 0.08:1; Recombinant humanized type III collagen 0.01%-0.5%; Trehalose 0.3%-0.7%; β-glucan 0.05%-0.3%, wherein the mass ratio of β-glucan with a molecular weight of less than 1000 Daltons to β-glucan with a molecular weight of 1000-8000 Daltons is 4:3; Moisturizer 3%-10%; Soothing and anti-inflammatory agents 0.1%-1%; pH adjuster 0.01%-0.5%; Preservatives: 0.01%-0.3%; Deionized water balance; The mass percentages of the four components—glyceroglucoside, recombinant humanized type III collagen, trehalose, and β-glucan—satisfy the following relationship: (glyceroglucoside + trehalose) / (recombinant humanized type III collagen + β-glucan) = 5-15.

[0013] As a further technical solution of the present invention: the molecular weight of the recombinant humanized type III collagen is 15kDa-50kDa.

[0014] As a further technical solution of the present invention: the moisturizer is a mixture of glycerin and betaine in a mass ratio of (2-3):1.

[0015] As a further technical solution of the present invention: the soothing and anti-inflammatory agent is a mixture of dipotassium glycyrrhizate and Centella asiatica extract in a mass ratio of 1:(1-3).

[0016] As a further technical solution of the present invention, its pH value is 5.5-6.0.

[0017] This invention also provides a method for preparing a moisturizing and repairing medical spray containing glyceryl glucoside as described above, comprising the following steps: Step 1, Aqueous phase preparation: Heat a portion of deionized water to 40-45℃, add glyceryl glucoside, trehalose, β-glucan and humectant, and stir at 200-300 rpm until completely dissolved; Step 2, Addition of active ingredients: Cool the solution obtained in step (1) to 32-37℃, add recombinant humanized type III collagen and soothing anti-inflammatory agent, and stir slowly at 100-150 rpm for 20-40 minutes; Step 3, pH adjustment and volume adjustment: Add pH adjuster to adjust the pH of the solution to 5.5-6.0, and add the remaining deionized water to the full volume; Step 4, Filtration and Sterilization: Filtration is performed sequentially using 0.45μm and 0.22μm microporous membranes. After filling, sterilization is carried out by cobalt-60 irradiation with an irradiation dose of 10-15 kGy.

[0018] As a further technical solution of the present invention: the cooling in step 2 adopts a programmed temperature control method, and the cooling rate is 1-2℃ / minute.

[0019] As a further technical solution of the present invention: the filtration in step 4 is carried out under nitrogen protection.

[0020] The present invention also provides the application of the above-described moisturizing and repairing medical spray containing glyceryl glucoside in the preparation of medical devices for improving skin barrier function, promoting wound healing or soothing skin inflammation.

[0021] This invention also provides the application of the above-described moisturizing and repairing medical spray containing glyceryl glucoside in the preparation of nursing products for post-medical aesthetic repair.

[0022] In summary, compared with the prior art, the present invention has at least one of the following beneficial technical effects: The synergistic effect is remarkable: Through a scientific formulation of glyceroglucosides (2-βGG to 2-αGG ratio of 0.08:1), β-glucan with a specific molecular weight distribution (<1000Da and 1000-8000Da mixed in a 4:3 ratio), recombinant humanized type III collagen, and trehalose, and satisfying a specific relationship, an unexpected synergistic effect is produced. Experiments show that compared with single ingredients or simple combinations, this formula improves moisturizing effect by more than 45% and accelerates repair speed by more than 60%.

[0023] Multi-functional in one: It combines immediate moisturizing and long-lasting hydration, while also providing multiple benefits such as barrier repair, anti-inflammatory soothing, and wound healing promotion, meeting the comprehensive care needs of various skin problems.

[0024] Extremely safe: Made with humanized recombinant collagen, it has low immunogenicity and good biocompatibility, avoiding the potential risks of animal-derived collagen, and is suitable for sensitive and damaged skin.

[0025] Excellent user experience: The spray is fine, absorbs quickly, and leaves no stickiness or residue, improving user comfort and compliance.

[0026] Excellent stability: By optimizing the preparation process and formulation, the product stability is significantly improved, and it can maintain its activity for more than 24 months at room temperature. Detailed Implementation

[0027] The technical solutions in the embodiments of this application will be clearly and completely described below with reference to the embodiments of this application. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of this application without creative effort are within the scope of protection of this application.

[0028] Example 1: Basic Formulation for Medical Spray This embodiment provides a moisturizing and repairing medical spray containing glyceryl glucoside, the formulation of which is as follows by weight percentage: Glyceryl glucoside (2-βGG:2-αGG=0.08:1) 0.8%; Type III recombinant humanized collagen (molecular weight 20kDa) 0.05%; Trehalose dihydrate 0.5%; β-glucan (<1000Da:1000-8000Da=4:3) 0.1%; 4% glycerol; betaine 2%; Dipotassium glycyrrhizate 0.1%; Centella asiatica extract 0.2%; Sodium hydroxide (10% aqueous solution), appropriate amount (to adjust pH to 5.8); 1,2-Hexanediol 0.2%; p-Hydroxyacetophenone 0.1%; Deionized water balance.

[0029] The mass percentages of glycerol glucoside, recombinant humanized type III collagen, trehalose, and β-glucan satisfy the following relationship: (glycerol glucoside + trehalose) / (recombinant humanized type III collagen + β-glucan) = 5-15. Verification of the relationship: (0.8 + 0.5) / (0.05 + 0.1) = 1.3 / 0.15 = 8.67, which meets the requirement of 5-15.

[0030] Preparation method: Aqueous phase preparation: Take 70% of the formula amount of deionized water, heat to 45℃, add glycerol glucoside, trehalose dihydrate, β-glucan, glycerol and betaine while stirring, stir at 250 rpm until completely dissolved to obtain an aqueous phase solution; Addition of active ingredients: The aqueous phase temperature was reduced to 35°C at a rate of 1.5°C / minute using a programmed temperature control method. Type III recombinant humanized collagen, dipotassium glycyrrhizate and Centella asiatica extract were added, and the mixture was slowly stirred at 120 rpm for 30 minutes until completely homogeneous. pH adjustment: Adjust the pH to 5.8 ± 0.1 using a 10% sodium hydroxide aqueous solution; Add water: Add the remaining deionized water to bring the level up to 100%; Filtration and filling: Under nitrogen protection, the filter is sequentially filtered through 0.45μm and 0.22μm microporous membranes and then filled into sterile spray bottles; Sterilization: Sterilization is performed by cobalt-60 irradiation at a dose of 12 kGy to obtain the final product.

[0031] Example 2: High-concentration active ingredient formulation This embodiment provides a medical spray with a high concentration of active ingredients, suitable for cases of severely damaged skin barrier. Its formulation, by weight percentage, is as follows: Glyceryl glucoside (2-βGG:2-αGG=0.08:1) 1.5%; Type III recombinant humanized collagen (molecular weight 30kDa) 0.22%; Trehalose dihydrate 0.6%; β-glucan (<1000Da:1000-8000Da=4:3) 0.2%; Butanediol 6%; Polyglycerol - 10 2%; 0.3% plant licorice extract; Ceramide 0.2%; Citric acid (10% aqueous solution), appropriate amount (to adjust pH to 5.8); 1,2-Hexanediol 0.3%; Deionized water balance.

[0032] The mass percentages of glycerol glucoside, recombinant humanized type III collagen, trehalose, and β-glucan satisfy the following relationship: (glycerol glucoside + trehalose) / (recombinant humanized type III collagen + β-glucan) = 5-15. Verification of the relationship: (1.5 + 0.6) / (0.22 + 0.2) = 2.1 / 0.42 = 5, which meets the requirement of 5-15.

[0033] The preparation method is basically the same as that in Example 1, except that the heating temperature in step 1 is 48°C, the stirring speed in step 2 is 400 rpm, and the stirring time is 40 minutes.

[0034] Example 3: Low-irritant formula suitable for sensitive skin This embodiment provides a low-irritation medical spray suitable for sensitive skin, with the following formula by weight percentage: Glyceryl glucoside (2-βGG:2-αGG=0.08:1) 0.6%; Type III recombinant humanized collagen (molecular weight 15kDa) 0.02%; Trehalose dihydrate 0.4%; β-glucan (<1000Da:1000-8000Da=4:3) 0.08%; Propylene glycol 4%; betaine 3%; Dipotassium glycyrrhizate 0.05%; Centella asiatica extract 0.1%; Sodium hydroxide (10% aqueous solution), appropriate amount (to adjust pH to 6.0); p-Hydroxyacetophenone 0.15%; Deionized water balance.

[0035] The mass percentages of glycerol glucoside, recombinant humanized type III collagen, trehalose, and β-glucan satisfy the following relationship: (glycerol glucoside + trehalose) / (recombinant humanized type III collagen + β-glucan) = 5-15. Verification of the relationship: (0.6 + 0.4) / (0.02 + 0.08) = 1.0 / 0.1 = 10, which meets the requirement of 5-15.

[0036] The preparation method is basically the same as that in Example 1, except that moist heat sterilization (121°C, 15 minutes) is used in step 5.

[0037] Comparative Example 1: Recipes that do not satisfy the relation To verify the importance of the relation in this invention, comparative examples that do not satisfy the relation are provided: Glyceryl glucoside (2-βGG:2-αGG=0.08:1) 0.3%; Type III recombinant humanized collagen (molecular weight 20kDa) 0.3%; Trehalose dihydrate 0.3%; β-glucan (<1000Da:1000-8000Da=4:3) 0.3%; The remaining components are the same as in Example 1; Relationship verification: (0.3+0.3) / (0.3+0.3)=0.6 / 0.6=1, which does not meet the requirements of 5-15.

[0038] Example 4: Performance Testing The performance of the medical sprays prepared in Examples 1-3 and Comparative Example 1 of this invention was tested, and the results are shown in Table 1 below: Table 1: Key Data Results of Performance Testing

[0039] Moisturizing performance test: The stratum corneum moisture content was measured using the Corneometer® CM825 capacitance method. Changes in hydration level were measured before product application and at 5 min, 1 h, 2 h, 4 h, and 8 h after application. The results are shown in Table 1. The moisturizing effect of the product in Example 1 was significantly better than that of the comparative product at different time points (P < 0.01). After 8 hours of use, the skin hydration level of the product in Example 1 remained above 85% of the value at 5 min after application, while that of the comparative product in Example 1 remained at only 65%.

[0040] Skin barrier repair test: The skin barrier was disrupted using an adhesive tape peeling method, and changes in transepidermal water loss (TEWL) were measured to evaluate the product's barrier repair function. The results are shown in Table 1. On days 3 and 7 after use, the TEWL value recovery of the product in Example 1 was significantly better than that of the comparative product (P < 0.01). On day 7, the TEWL value of Example 1 recovered to 95% of the normal level, while that of Comparative Example 1 only recovered to 78%.

[0041] Wound healing test: The product's effect on promoting wound healing was evaluated through an in vitro cell scratch assay. The results are shown in Table 1. The cell migration rate of the product in Example 1 of this invention was significantly higher than that of the comparative product at both 24 and 48 hours (P < 0.01). Example 1 achieved a scratch healing rate of 92% at 48 hours, while the comparative product was only 68%.

[0042] Synergistic effect verification: As shown in Table 1, Examples 1-3, which satisfy the specific relationship formula of this invention (ratio between 5 and 15), are significantly better than Comparative Example 1, which does not satisfy the relationship formula, in terms of moisturizing, barrier repair, and wound healing (P<0.01). This proves that the active ingredients produce an unexpected synergistic effect under specific ratios.

[0043] Skin irritation test: The irritation of the product was evaluated using the chicken embryo chorioallantoic membrane test (HET-CAM). The results are shown in Table 1. The irritation score of the product in Example 1 of this invention was 0.2, which indicates that it is a non-irritating product.

[0044] Example 5: Stability Test Accelerated stability tests were conducted on the product of Example 1 (40℃±2℃, relative humidity 75%±5%, for 6 months), and the changes in key indicators are shown in the table below.

[0045] Table 2: Key Data Table for Product Stability Test in Example 1

[0046] The stability test of the product in Example 1 of this invention showed that after being placed at 40℃±2℃ and relative humidity of 75%±5% for 6 months, all indicators met the requirements. Under accelerated test conditions, the key indicators of the product did not change significantly, and the content of active ingredients remained above 97%, indicating that the product has excellent stability.

[0047] The moisturizing and repairing medical spray containing glyceryl glucoside involved in this invention demonstrates remarkable synergistic effects in experimental data through its unique combination and ratio of ingredients, which is key to proving its inventiveness. Specifically, the four active ingredients in its formula—glyceryl glucoside (specific isomer ratio), recombinant humanized type III collagen, trehalose, and β-glucan (specific molecular weight combination)—are not simply added together, but precisely proportioned according to the specific relationship "(glyceryl glucoside + trehalose) / (recombinant humanized type III collagen + β-glucan) = 5-15". Experiments have shown that the formula satisfying this relationship is significantly more effective than the control formula that does not satisfy this relationship in skin barrier repair (such as the restoration of transepidermal water loss value TEWL) and wound healing (such as cell migration rate). The improvement (such as a repair speed increase of more than 60%) exceeds the effect that a person skilled in the art could expect based on conventional knowledge, demonstrating an unexpected synergistic effect between the ingredients.

[0048] Secondly, this spray integrates multiple functions, including immediate hydration and long-lasting repair, barrier repair and anti-inflammatory soothing, solving the technical problem of existing products having only one function. Compared with products on the market that mainly focus on single hydration or basic repair, the recombinant humanized type III collagen in this invention's formula can directly participate in the construction and repair of the skin barrier structure, while the specific combination of glyceryl glucoside, trehalose, and β-glucan enhances the moisturizing function of the stratum corneum and promotes wound healing. Performance test data shows that the product can still maintain more than 85% skin hydration after 8 hours of use, and can effectively accelerate the healing process of skin damage such as after laser treatment and minor wounds, and soothe sensitive symptoms such as redness and stinging. This integrated effect cannot be achieved by a simple combination of existing technologies.

[0049] Finally, the technical solution boasts significant advantages in safety and stability, further demonstrating its inventiveness. The product utilizes humanized recombinant collagen, exhibiting high biocompatibility and low immunogenicity, thus reducing the risk of allergies from the source. It is suitable for sensitive skin and fragile skin with damaged barriers, such as after cosmetic procedures. Accelerated stability testing proves that after six months of storage under harsh conditions, the content of its main active ingredients remains above 97%, far exceeding industry standards. This is attributed to its optimized preparation process (such as programmed temperature control and nitrogen-protected filtration) and stable formulation system. This integration of high efficiency, safety, and stability is a strong support for the invention's inventiveness.

[0050] The implementation principle of this invention is as follows: This invention discloses a moisturizing and repairing medical spray containing glyceryl glucoside and its preparation method. By weight percentage, it comprises the following components: 0.5%-2% glyceryl glucoside (where the mass ratio of 2-βGG to 2-αGG is 0.08:1), 0.01%-0.5% recombinant humanized type III collagen, 0.3%-0.7% trehalose, 0.05%-0.3% β-glucan (with a specific molecular weight ratio), 3%-10% moisturizer, 0.1%-1% soothing and anti-inflammatory agent, 0.01%-0.5% pH adjuster, 0.01%-0.3% preservative, and the balance being deionized water; wherein the four active components satisfy a specific relationship. This invention also provides a preparation method and application of the aforementioned medical spray. The medical spray of this invention achieves excellent moisturizing performance, barrier repair function, wound healing activity and soothing and anti-inflammatory effects through the specific ratio and synergistic formulation of each active ingredient. It is also highly safe, provides a good user experience, and is suitable for various skin types, especially sensitive and damaged skin.

[0051] The embodiments described herein are preferred embodiments of the present invention and are not intended to limit the scope of protection of the present invention. Therefore, all equivalent changes made in accordance with the structure, shape, and principle of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A moisturizing and repairing medical spray containing glyceryl glucoside, characterized in that, By weight percentage, it consists of the following components: Glyceryl glucoside 0.5%-2%, wherein the mass ratio of 2-β-glyceryl glucoside to 2-α-glyceryl glucoside is 0.08:1; Recombinant humanized type III collagen 0.01%-0.5%; Trehalose 0.3%-0.7%; β-glucan 0.05%-0.3%, wherein the mass ratio of β-glucan with a molecular weight of less than 1000 Daltons to β-glucan with a molecular weight of 1000-8000 Daltons is 4:3; Moisturizer 3%-10%; Soothing and anti-inflammatory agents 0.1%-1%; pH adjuster 0.01%-0.5%; Preservatives: 0.01%-0.3%; Deionized water balance; The mass percentages of the four components—glyceroglucoside, recombinant humanized type III collagen, trehalose, and β-glucan—satisfy the following relationship: (glyceroglucoside + trehalose) / (recombinant humanized type III collagen + β-glucan) = 5-15.

2. The moisturizing and repairing medical spray containing glyceryl glucoside according to claim 1, characterized in that, The recombinant humanized type III collagen has a molecular weight of 15kDa-50kDa.

3. A moisturizing and repairing medical spray containing glyceryl glucoside according to claim 1 or 2, characterized in that, The humectant is a mixture of glycerin and betaine in a mass ratio of (2-3):

1.

4. A moisturizing and repairing medical spray containing glyceryl glucoside according to any one of claims 1-3, characterized in that, The soothing and anti-inflammatory agent is a mixture of dipotassium glycyrrhizate and Centella asiatica extract in a mass ratio of 1:(1-3).

5. A moisturizing and repairing medical spray containing glyceryl glucoside according to any one of claims 1-4, characterized in that, Its pH value is 5.5-6.

0.

6. A method for preparing a moisturizing and repairing medical spray containing glyceryl glucoside as described in any one of claims 1-5, characterized in that, Includes the following steps: Step 1, Aqueous phase preparation: Heat a portion of deionized water to 40-45℃, add glyceryl glucoside, trehalose, β-glucan and humectant, and stir at 200-300 rpm until completely dissolved; Step 2, Addition of active ingredients: Cool the solution obtained in step (1) to 32-37℃, add recombinant humanized type III collagen and soothing anti-inflammatory agent, and stir slowly at 100-150 rpm for 20-40 minutes; Step 3, pH adjustment and volume adjustment: Add pH adjuster to adjust the pH of the solution to 5.5-6.0, and add the remaining deionized water to the full volume; Step 4, Filtration and Sterilization: Filtration is performed sequentially using 0.45μm and 0.22μm microporous membranes. After filling, sterilization is carried out by cobalt-60 irradiation with an irradiation dose of 10-15 kGy.

7. The preparation method of the moisturizing and repairing medical spray containing glyceryl glucoside according to claim 6, characterized in that, The cooling process described in step 2 uses a programmed temperature control method, with a cooling rate of 1-2℃ / minute.

8. The method for preparing a moisturizing and repairing medical spray containing glyceryl glucoside according to claim 6 or 7, characterized in that, The filtration described in step 4 is carried out under nitrogen protection.

9. The use of a moisturizing and repairing medical spray containing glyceryl glucoside as described in any one of claims 1-5 in the preparation of a medical device for improving skin barrier function, promoting wound healing, or soothing skin inflammation.

10. The use of a moisturizing and repairing medical spray containing glyceryl glucoside as described in any one of claims 1-5 in the preparation of a nursing product for post-medical aesthetic repair.

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