A multi-target soothing cream for infants and children and a preparation method thereof

Abstract

The application belongs to the technical field of daily chemicals, and discloses a multi-target itch-relieving soothing cream for infants and children and a preparation method thereof. The cream contains the following active ingredients in percentage by weight: hydroxyphenylpropionamide benzoic acid 0.01%-0.05%, 4-tert-butylcyclohexanol 0.3%-0.6%, menthol lactate 0.01%-0.1%, perilla seed oil 1.0%-3.0%, artemisia leaf extract 1.0%-3.0%, ectoine 0.5%-2.0%, panthenol 1.0%-3.0%, and alpha-glucan oligosaccharide 0.3%-1.5%. The application realizes the unity of rapid itch relief and long-term soothing through the synergistic effect of the four-layer function framework of "fast-acting nerve block + fat-soluble anti-inflammatory + water-soluble anti-inflammatory repair + microecological regulation". The cream has a pH of 5.0-5.5, adopts a non-ionic emulsification system, is mild and non-irritating, and is particularly suitable for infants and children. Experiments show that the complete formula of the application has an itch-relieving onset time of less than or equal to 10 minutes, and the proportion of 80% of the infants and children reach the effect within 10 minutes. The proportion of infants and children who need to repeat the application within 24 hours is only 13%. The BSA heat denaturation inhibition rate is 64.7%-73.2%, and all indexes are significantly better than those of the defect control groups.

Description

Technical Field

[0001] This invention belongs to the field of daily chemical products technology, specifically relating to an anti-itch skin care product for infants and children, and more particularly to an anti-itch and soothing cream for infants and children that achieves rapid anti-itch and long-lasting soothing through multi-target synergistic action, and its preparation method. Background Technology

[0002] Skin itching is a common skin discomfort symptom among children, mainly caused by factors such as insect bites, atopic dermatitis, prickly heat, and dry skin. With increasing public awareness of children's skin health, the market demand for children's anti-itch care products continues to grow. Currently, the main problems with children's anti-itch products on the market are as follows:

[0003] (1) The safety of chemical antipruritic products is limited. These products usually contain ingredients such as diphenhydramine, camphor, and glucocorticoids, which may have an inhibitory effect on the central nervous system of children, or cause skin atrophy, telangiectasia, pigmentation, or even affect the normal growth and development of children.

[0004] (2) The existing technology lacks a technical solution that systematically integrates multi-dimensional antipruritic mechanisms. Existing patents, such as CN107714531A, disclose an anti-allergic and soothing composition containing 4-tert-butylcyclohexanol and hydroxyphenylpropionamide benzoic acid, focusing on soothing and relieving itching at the neurological level. Other patents disclose an anti-inflammatory, antibacterial, and antipruritic cream containing perilla seed oil (CN105106566B) and an infant antipruritic ointment containing perilla or its extracts (CN111110758A). However, the above technical solutions only focus on a single or dual antipruritic mechanism and do not involve a technical solution that systematically integrates TRPV1 antagonism, TRPM8 mild activation, lipid-soluble anti-inflammatory (ω-3 fatty acid metabolism to mediators such as resolvin), water-soluble anti-inflammatory (NF-κB / MAPK pathway inhibition), and microecological regulation.

[0005] (3) Existing products neglect the connection between skin microecological balance and itching. Infants' skin barriers are not fully developed, and excessive colonization of pathogenic bacteria such as Staphylococcus aureus can induce Th2 immune responses and the release of itch-controlling factors such as IL-31, forming a vicious cycle of "itching-scratching-barrier damage-microbial imbalance-inflammation". Existing products mostly focus on post-inflammatory itch relief and lack strategies to reduce the recurrence of itching from the source through microecological regulation.

[0006] (4) Existing products have a single anti-inflammatory dimension. The oil components (such as squalane and mineral oil) in existing antipruritic products mainly serve as inert carriers for occlusion and moisturization, without fully utilizing the active anti-inflammatory value of ω-3 fatty acids in functional plant oils; at the same time, existing technologies only focus on water-soluble anti-inflammatory pathways (such as NF-κB / MAPK inhibition), without systematically integrating lipid-soluble anti-inflammatory mediators (such as resolvin, protectin, etc.) with water-soluble anti-inflammatory agents.

[0007] (5) The pH design does not match the physiological characteristics of infants' skin. Some existing products have a pH that is neutral or weakly alkaline (>6.0), which damages the natural acidic protective film of infants' skin, weakens the barrier function, and increases the risk of pathogenic bacteria colonization.

[0008] (6) The selection of the emulsification system did not fully consider the compatibility with infant skin and the emulsification requirements of functional oils. CN107951771A discloses an infant soothing and moisturizing skin cream containing cetearyl glucoside. There is no existing technical solution for systematically combining cetearyl glucoside with functional plant oils such as perilla seed oil under weakly acidic conditions. Summary of the Invention

[0009] To address the aforementioned technical deficiencies in the prior art, this invention provides an antipruritic and soothing cream for infants and children that achieves rapid itch relief and long-lasting soothing through multi-target synergistic action, as well as its preparation method.

[0010] The basic principle of the cream of this invention is to achieve synergistic antipruritic effect through a four-layer efficacy framework of "rapid nerve blockade + lipid-soluble anti-inflammatory + water-soluble anti-inflammatory repair + microecological regulation":

[0011] Rapidly acting nerve blocking layer: Hydroxyphenyl propionamide benzoic acid achieves rapid antipruritic effect by stabilizing mast cell membranes, antagonizing NK1 receptors, and inhibiting downstream TRPV1 signals; 4-tert-butylcyclohexanol directly blocks TRPV1 ion channels from the receptor end, and the two form a "receptor blocking + signal inhibition" dual-locking mechanism; Menthol lactate gently activates TRPM8 cold receptors, forming a "cold-heat counteracting" synergy with TRPV1 blocking.

[0012] Lipid-soluble anti-inflammatory layer: Perilla seed oil is rich in α-linolenic acid (≥50%), which is metabolized locally in the skin by lipoxygenase and cyclooxygenase into lipid-soluble anti-inflammatory mediators such as resolvin, protectin and maresin, thereby inhibiting the inflammatory cascade response from a lipid-soluble perspective.

[0013] Water-soluble anti-inflammatory repair layer: Artemisia argyi extract inhibits the release of inflammatory mediators through multiple pathways including NF-κB / MAPK / COX-2; Ectoin inhibits inflammatory signals by promoting the expression of heat shock proteins and stabilizing cell osmotic pressure; Panthenol promotes keratinocyte proliferation and accelerates skin repair.

[0014] Microecological regulation layer: α-glucan oligosaccharides act as prebiotics to promote the colonization of beneficial bacteria such as Staphylococcus epidermidis, reducing the recurrence of itching from the source.

[0015] To achieve the above objectives, the present invention adopts the following technical solution:

[0016] The first aspect of the present invention is to provide a multi-target antipruritic and soothing cream for infants and children, comprising the following components by weight percentage:

[0017] Hydroxyphenylpropionamide benzoic acid 0.01%~0.05%

[0018] 4-tert-butylcyclohexanol 0.3%~0.6%

[0019] Menthol lactate 0.01%~0.1%

[0020] Perilla seed oil 1.0%~3.0%

[0021] Artemisia argyi extract 1.0%~3.0%

[0022] Ectocin 0.5%~2.0%

[0023] Panthenol 1.0%~3.0%

[0024] α-Glucan oligosaccharides 0.3%~1.5%

[0025] Cetearyl glucoside 0.5%~2.0%

[0026] Cetearyl alcohol 1.0%~3.0%

[0027] Caprylic / capric triglycerides: 8.0%~15.0%

[0028] Squalane 5.0%~10.0%

[0029] Butylene glycol 4.0%~8.0%

[0030] Raspberry ketone 0.3%~0.4%

[0031] 1,2-Hexanediol 0.3%~1.0%

[0032] Carbomer 0.2%~0.6%

[0033] Add an appropriate amount of arginine and adjust the pH to 5.0-5.5.

[0034] Deionized water balance up to 100%.

[0035] Preferably, the weight percentage of the hydroxyphenylpropionamide benzoic acid is 0.03%, the weight percentage of the 4-tert-butylcyclohexanol is 0.6%, and the weight percentage of the menthol lactate is 0.03%.

[0036] Preferably, the perilla seed oil has a weight percentage of 2.0%, and the perilla seed oil contains ≥50% α-linolenic acid. Preferably, the artemisia argyi extract has a weight percentage of 2.0%, the ectoine has a weight percentage of 1.0%, the panthenol has a weight percentage of 2.0%, and the artemisia argyi extract contains ≥10% total flavonoids.

[0037] Preferably, the weight percentage of the α-glucan oligosaccharide is 0.5% to 1.2%, more preferably 0.8%.

[0038] Preferably, the weight percentage of cetearyl glucoside is 1.0% to 1.5%, the weight percentage of cetearyl alcohol is 1.0% to 2.0%, the weight percentage of caprylic / capric triglyceride is 8.0% to 12%, and the weight percentage of squalane is 7.0% to 9.0%.

[0039] More preferably, the weight percentage of cetearyl glucoside is 1.0%, the weight percentage of cetearyl alcohol is 2.0%, the weight percentage of caprylic / capric triglyceride is 10%, and the weight percentage of squalane is 8.0%.

[0040] Preferably, the weight percentage of butylene glycol is 5.0%, the weight percentage of raspberry ketone is 0.4%, the weight percentage of 1,2-hexanediol is 0.5%, the weight percentage of carbomer is 0.4%, and the weight percentage of arginine is 0.8%-1.5%; the carbomer used is Ultraz 21.

[0041] Preferably, the pH value of the multi-target antipruritic and soothing cream is adjusted to 5.0-5.5 by the arginine, and the mass percentage concentration of the arginine is 20%.

[0042] A second aspect of the present invention is to provide a method for preparing a multi-target antipruritic and soothing cream for infants as described in any of the preceding claims, comprising the following steps:

[0043] S1 Oil phase preparation: Cetearyl glucoside, cetearyl alcohol, caprylic / capric triglyceride, squalane, and perilla seed oil are mixed and heated to 75~85℃ and stirred to dissolve; 4-tert-butylcyclohexanol and menthol lactate are added and stirred until completely dissolved to form the oil phase;

[0044] S2 Aqueous Phase Preparation: Deionized water and a portion of butanediol are mixed, heated to 75-85°C, and stirred to dissolve, forming the aqueous phase; a portion of the deionized water is reserved for carbomer swelling.

[0045] S3 Emulsification: Add the oil phase to the aqueous phase and homogenize and emulsify at 75~85℃ and 2000~3000rpm for 10~15 minutes to form an oil-in-water emulsion;

[0046] S4 Cooling: Cool the emulsion to 40~45℃ with stirring;

[0047] S5 Low-temperature feeding: Add the hydroxyphenylpropionamide benzoic acid solution pre-dissolved in the remaining butanediol, ectoine, Artemisia argyi extract aqueous solution, panthenol aqueous solution, α-glucan oligosaccharide aqueous solution, and the mixture of raspberry ketone and 1,2-hexanediol in sequence, with an interval of 3-5 minutes between each feeding, and stir at 300-500 rpm for 15-20 minutes.

[0048] S6 In-situ gelation: Carbomer powder was pre-dispersed in reserved deionized water and swollen at room temperature for 2 hours. It was then added to the above emulsion and stirred at 35-40°C and 300-500 rpm for 20 minutes. Arginine solution was slowly added dropwise to adjust the pH to 5.0-5.5.

[0049] S7 Aging: Let stand at room temperature for 12-24 hours to obtain.

[0050] Preferably, the homogenization emulsification speed in S3 is 2500 rpm and the time is 12 minutes.

[0051] Preferably, in S5, the hydroxyphenylpropionamide benzoic acid is pre-dissolved in butanediol at a temperature of 40-45°C, and then cooled to room temperature before being added.

[0052] The present invention adopts the above technical solution and has the following technical effects compared with the prior art:

[0053] (1) Synergistic antipruritic effect of four-layer efficacy structure: This invention breaks through the limitations of existing products that rely solely on nerve level blockade or single anti-inflammatory pathway. Human trial data of Experiment Example 3 showed that the proportion of people with ≤10min antipruritic effect of the complete four-layer formula reached 80% (12 / 15), the 30min significant relief rate of itching reached 87% (13 / 15), the proportion of people who needed to repeat the application within 24 hours was only 13% (2 / 15), the proportion of people who applied the product ≤1 time per day on the 7th day reached 80% (12 / 15), and the parent satisfaction rate reached 93% (14 / 15). All indicators were significantly better than the control groups with defects.

[0054] (2) Synergistic effect of lipid-soluble and water-soluble anti-inflammatory agents: This invention is the first to systematically integrate perilla seed oil rich in α-linolenic acid (≥50%) at a ratio of 1.0%~3.0% with the water-soluble NF-κB / MAPK inhibition of Artemisia argyi flavonoids and the intracellular homeostasis protection of ectoine, forming a three-dimensional synergy of "lipid-soluble anti-inflammatory + water-soluble anti-inflammatory + intracellular homeostasis". The BSA thermal denaturation inhibition experiment of Experiment Example 4 showed that the inhibition rate of Example 1 (perilla seed oil 1.0%) was 64.7%, the inhibition rate of Example 3 (perilla seed oil 3.0%) reached 73.2%, while the inhibition rate of Comparative Example 4, which lacked perilla seed oil, was only 41.5%, showing a clear dose-dependent relationship.

[0055] (3) Microecological regulation reduces itching recurrence from the source: α-glucan oligosaccharide, as a prebiotic, promotes the colonization of beneficial bacteria, which helps maintain the balance of the skin microenvironment and reduces the release of pruritus factors such as IL-31 from the source.

[0056] (4) The weakly acidic pH is in line with the physiological characteristics of infant skin: The pH of the system is controlled at 5.0~5.5, which is in line with the natural acidic protective film characteristics of infant skin and maintains the stability of the skin microenvironment; α-glucan oligosaccharide, as a prebiotic, promotes the colonization of beneficial bacteria and helps maintain the balance of the skin microenvironment.

[0057] (5) Infant-specific safety design: strictly excludes traditional high-risk ingredients such as diphenhydramine, glucocorticoids, camphor, and menthol; menthol lactate is controlled at an extremely low concentration (≤0.1%); and a mild preservative system of raspberry ketone and 1,2-hexanediol is used.

[0058] (6) Nonionic emulsification system is suitable for weakly acidic environment and functional oils: Cetearyl glucoside is a nonionic surfactant that remains stable under weakly acidic conditions, is gentle and low-irritant to infant skin, and has excellent emulsifying affinity for plant oils such as perilla seed oil. Detailed Implementation

[0059] The present invention will be further described in detail below with reference to embodiments. It should be understood that the specific embodiments described herein are for illustrative purposes only and do not constitute a limitation thereof.

[0060] Example 1: Basic Balance Type (Daily Care)

[0061] (1) This multi-target antipruritic and soothing cream for infants and children is composed of the following components by weight percentage:

[0062] (2) This multi-target antipruritic and soothing cream for infants and children is prepared using the following method:

[0063] S1 Oil phase preparation: 1.0% cetearyl glucoside, 2.0% cetearyl alcohol, 10.0% caprylic / capric triglyceride, 10.0% squalane, and 1.0% perilla seed oil were mixed, heated to 80℃, and stirred to dissolve; 0.5% 4-tert-butylcyclohexanol and 0.03% menthol lactate were added, and stirring was continued until completely dissolved to obtain the oil phase.

[0064] S2 Aqueous Phase Preparation: Deionized water (with a portion reserved for carbomer swelling) and 5.0% butanediol are mixed, heated to 80°C, and stirred to dissolve, thus forming the aqueous phase.

[0065] S3 Emulsification: Add the oil phase to the aqueous phase and homogenize and emulsify at 80°C and 2500 rpm for 12 minutes to form an oil-in-water emulsion.

[0066] S4 Cooling: Cool the emulsion to 40~45℃ with stirring.

[0067] S5 Low-Temperature Feeding: Add sequentially the following solutions: 0.03% hydroxyphenylpropionamide benzoic acid pre-dissolved in 1.0% butanediol (stirring at 40-45℃ for 15 minutes to aid dissolution, then cooling to room temperature); 1.0% ectoine; 2.0% aqueous solution of Artemisia argyi extract; 2.0% aqueous solution of panthenol; 0.8% aqueous solution of α-glucan oligosaccharide; and a mixture of 0.4% raspberry ketone and 0.5% 1,2-hexanediol. Add each solution 4 minutes apart, stirring at 400 rpm for 15 minutes.

[0068] S6 In-situ gelation: Carbomer 0.4% was pre-dispersed in reserved deionized water and swollen at room temperature for 2 hours. It was then added to the above emulsion and stirred at 35°C and 400 rpm for 20 minutes. Arginine solution (20%) was slowly added dropwise to adjust the pH to 5.2.

[0069] S7 Aging: Let stand at room temperature for 18 hours before bottling.

[0070] Product Features: Fine, creamy texture, pH 5.2, providing fast relief from itching, a gentle cooling sensation, and long-lasting soothing, suitable for daily skin care for infants and children with itchy skin.

[0071] Example 2: Outdoor Enhanced Type (Highly Active Formula)

[0072] (1) This multi-target antipruritic and soothing cream for infants and children is composed of the following components by weight percentage:

[0073] (2) The preparation method of this multi-target antipruritic and soothing cream for infants is the same as in Example 1. The temperature of the oil phase and the water phase is controlled at 85°C. After homogenization and emulsification, the temperature is lowered to below 40°C before adding the ingredients. Arginine is used to adjust the pH to 5.1.

[0074] Product Features: Targets acute redness, swelling, and itching after mosquito bites; pH 5.1 for faster itch relief; ectoine content increased to 1.5%, enhancing cell protection and anti-inflammatory repair, suitable for use after outdoor activities in summer.

[0075] Example 3: Gentle Repair Formula for Sensitive Skin (High-Lipid Anti-inflammatory)

[0076] (1) This multi-target antipruritic and soothing cream for infants and children is composed of the following components by weight percentage:

[0077] (2) The preparation method of this multi-target antipruritic and soothing cream for infants is the same as in Example 1, except that the emulsification temperature is controlled at 75°C, the homogenization speed is reduced, and the stirring time is extended. Arginine is used to adjust the pH to 5.3.

[0078] Product Features: Targeted for atopic dermatitis and highly sensitive skin, pH 5.3, reduces nerve blockade concentration to minimize irritation, and increases perilla seed oil and panthenol content to enhance lipid-soluble anti-inflammatory and skin-repairing effects.

[0079] Comparative Example 1: Lack of Microecological Regulation Layer

[0080] Same as Example 1, but with 0.8% α-glucan oligosaccharide removed, the amount of which was made up with deionized water. This was used to compare with Example 1 and verify the effect of the microecological regulation layer on reducing the recurrence rate of itching.

[0081] Comparative Example 2: Lack of neural blocking layer

[0082] Same as in Example 1, but with the removal of 0.03% hydroxyphenylpropionamide benzoic acid, 0.5% 4-tert-butylcyclohexanol, and 0.03% menthol lactate, the amounts of which were made up with deionized water. This was used to compare with Example 1 and verify the contribution of the rapid-acting nerve blocking layer to the onset of antipruritic effects.

[0083] Comparative Example 3: Lack of Anti-inflammatory Repair Layer

[0084] Same as Example 1, but with the removal of 2.0% Artemisia argyi extract, 1.0% ectoine, and 2.0% panthenol, the amounts of which were made up with deionized water. This was used to compare with Example 1 and verify the contribution of the water-soluble anti-inflammatory repair layer to long-lasting relief and anti-inflammatory activity.

[0085] Comparative Example 4: Lipid-deficient anti-inflammatory layer

[0086] Same as Example 3, but with the perilla seed oil content reduced by 3.0% and the squalane content increased to 11.0% to make up the difference. This was used to compare the in vitro anti-inflammatory effects with those of Example 3, verifying the independent contribution of the lipid-soluble anti-inflammatory layer.

[0087] Comparative Example 5: Core combination containing only fast-acting nerve blocking layer

[0088] This comparative example contains only the core combination of hydroxyphenylpropionamide benzoic acid and 4-tert-butylcyclohexanol, and does not include the lipid-soluble anti-inflammatory layer (perilla seed oil), the water-soluble anti-inflammatory repair layer (Artemisia argyi extract, ectoine, panthenol), the microecological regulation layer (α-glucan oligosaccharide), and the TRPM8 activator (menthol lactate), with a pH of 5.3. It was used to compare the in vitro anti-inflammatory effects with Examples 1 and 3, verifying the significant superiority of the four-layer architecture compared to that containing only nerve-blocking components. The specific formulation composition is as follows:

[0089] Comparative Example 6: Lipid-deficient anti-inflammatory layer (human trial control)

[0090] The comparative ratio was the same as in Example 1, but 1.0% of perilla seed oil was removed, and squalane was increased to 11.0% to compensate. While retaining the occlusive moisturizing function of squalane, the lipid-soluble anti-inflammatory dimension derived from ω-3 fatty acids was completely removed. This was used for human trials to compare with Example 1, verifying the irreplaceable role of the lipid-soluble anti-inflammatory layer in actual human use.

[0091] Experimental verification and data analysis:

[0092] Experimental Example 1: Physicochemical Properties

[0093] Routine physical and chemical tests were performed on Examples 1-3 before they left the factory.

[0094]

[0095] Conclusion: The physicochemical indicators of all three batches of products meet the quality standards for creams.

[0096] Experimental Example 2: Microbial Limit Detection

[0097] Routine microbial limit tests were performed on Examples 1-3 (in accordance with the Cosmetic Safety Technical Specifications).

[0098]

[0099] Conclusion: The microbiological indicators of all three batches of products met the hygiene standards for infant and child cosmetics.

[0100] Experiment Example 3: Human Trial Observation (Four-layer Efficacy Verification)

[0101] Verification method: Fifty children aged 3-12 years with mosquito bites or mild itchy skin were recruited and randomly divided into 4 groups:

[0102] Group A: Apply Example 1 (complete four-layer formula), n=15

[0103] Group B: Application of Comparative Example 2 (without nerve block layer), n=10

[0104] Group C: Apply the treatment from Comparative Example 3 (lacking anti-inflammatory repair layer), n=10

[0105] Group D: Apply Comparative Example 6 (lipid-deficient anti-inflammatory layer), n=15

[0106] Apply once in the morning and once in the evening for 7 consecutive days. Parents should record the following indicators daily:

[0107] in conclusion:

[0108] (1) The complete four-layer formula (Group A) was significantly better than the control groups with defects in terms of antipruritic onset speed (80%≤10min), relief depth (87% significant relief) and long-term maintenance (13% required repeated application), proving that the four-layer structure has a synergistic effect.

[0109] (2) The group lacking the nerve blocking layer (Group B) had the worst rapid antipruritic index (30% ≤ 10 min, 40% significant relief), proving that the nerve blocking layer is irreplaceable for immediate antipruritic effect.

[0110] (3) The group lacking the anti-inflammatory repair layer (Group C) had the worst long-term performance (40% of the patients needed to be reapplied within 24 hours, and only 30% of the patients could be reapplied ≤ once a day on the 7th day), which proves that the water-soluble anti-inflammatory repair layer plays a key role in maintaining long-term anti-inflammatory effects and reducing recurrence.

[0111] (4) The group lacking the lipid-soluble anti-inflammatory layer (Group D) had significantly lower scores than the complete formula in all indicators (60% vs 80% efficacy, 67% vs 87% relief, and 53% vs 93% satisfaction), but slightly better than the group lacking nerve blockade. This indicates that the lipid-soluble anti-inflammatory layer does not simply provide moisturizing function (Comparative Example 6 already supplemented the total amount of oil with squalane), but rather supplements the inflammatory cascade that water-soluble anti-inflammatory agents cannot cover by metabolizing ω-3 fatty acids into lipid-soluble anti-inflammatory mediators such as resolvin.

[0112] (5) No adverse reactions were observed in any of the four groups, indicating that the product is safe.

[0113] Experiment Example 4: In vitro anti-inflammatory activity and synergistic verification of the four-layer structure (BSA thermal denaturation inhibition method)

[0114] The anti-inflammatory activity of the cream extract was detected using the BSA thermal denaturation inhibition method. Extracts were prepared for Examples 1, 3, Comparative Example 3 (lacking the anti-inflammatory repair layer), Comparative Example 4 (lacking perilla seed oil), and Comparative Example 5 (containing only the nerve-blocking core combination). A suitable amount of sample was mixed with 1% bovine serum albumin (BSA) solution, heated to 70°C and incubated for 10 minutes. After cooling, the absorbance was measured at 660 nm. Sodium salicylate was used as a positive control, and PBS as a blank control.

[0115]

[0116] in conclusion:

[0117] (1) The BSA inhibition rate of Example 1 (1.0% perilla seed oil) with complete four-layer formulation was 64.7%, while that of Example 3 (3.0% perilla seed oil) was 73.2%, and that of Comparative Example 4 (complete removal of perilla seed oil) was only 41.5%, showing a clear dose-dependent relationship, which proves that the fat-soluble anti-inflammatory layer makes a significant contribution to the gain.

[0118] (2) The inhibition rate of Comparative Example 5 (containing only hydroxyphenylpropionamide benzoic acid + 4-tert-butylcyclohexanol) was only 32.1%, which was much lower than that of the complete four-layer formulation, proving that the anti-inflammatory activity of the four-layer structure far exceeded that of the scheme containing only the nerve blocking component.

[0119] (3) The inhibition rate of Comparative Example 3 (lacking anti-inflammatory repair layer) was only 15.3%, proving that the water-soluble anti-inflammatory repair layer is irreplaceable.

[0120] (4) In vitro anti-inflammatory data and human trial results corroborate each other: Each layer in the four-layer architecture has an independent and irreplaceable contribution, and the four layers work together to produce unexpected technical effects that are superior to any single layer or partial combination.

[0121] Experiment Example 5: Accelerated Stability Test

[0122] The cream prepared in Example 3 was stored at 40±2℃ and RH75±5% for 3 months. Samples were taken at 0, 1, 2 and 3 months to test its appearance, pH, centrifugal stability and microbial indicators.

[0123]

[0124] Conclusion: The appearance, pH, centrifugal stability and microbial indicators of Example 3 remained stable for 3 months under accelerated conditions at 40℃, indicating that the cream of the present invention has excellent stability and the formula containing perilla seed oil can be stored stably for a long time in a non-ionic emulsion system.

[0125] The specific embodiments of the present invention have been described in detail above, but they are merely examples, and the present invention is not limited to the specific embodiments described above. For those skilled in the art, any equivalent modifications and substitutions to the present invention are also within the scope of the present invention. Therefore, all equivalent transformations and modifications made without departing from the spirit and scope of the present invention should be covered within the scope of the present invention.

Claims

1. A multi-target antipruritic and soothing cream for infants and children, characterized in that, It consists of the following components by weight percentage: Hydroxyphenylpropionamide benzoic acid 0.01%~0.05% 4-tert-butylcyclohexanol 0.3%~0.6% Menthol lactate 0.01%~0.1% Perilla seed oil 1.0%~3.0% Artemisia argyi extract 1.0%~3.0% Ectocin 0.5%~2.0% Panthenol 1.0%~3.0% α-Glucan oligosaccharides 0.3%~1.5% Cetearyl glucoside 0.5%~2.0% Cetearyl alcohol 1.0%~3.0% Caprylic / capric triglycerides: 8.0%~15.0% Squalane 5.0%~10.0% Butylene glycol 4.0%~8.0% Raspberry ketone 0.3%~0.4% 1,2-Hexanediol 0.3%~1.0% Carbomer 0.2%~0.6% Add an appropriate amount of arginine and adjust the pH to 5.0-5.

5. Deionized water balance up to 100%.

2. The cream according to claim 1, characterized in that, The weight percentage of the hydroxyphenylpropionamide benzoic acid is 0.03%, the weight percentage of the 4-tert-butylcyclohexanol is 0.6%, and the weight percentage of the menthol lactate is 0.03%.

3. The cream according to claim 1, characterized in that, The perilla seed oil has a weight percentage of 2.0%, and the perilla seed oil contains ≥50% α-linolenic acid.

4. The cream according to claim 1, characterized in that, The Artemisia argyi extract contains 2.0% by weight, ectoine contains 1.0% by weight, and panthenol contains 2.0% by weight; and the total flavonoid content in the Artemisia argyi extract is ≥10%.

5. The cream according to claim 1, characterized in that, The weight percentage of the α-glucan oligosaccharide is 0.5% to 1.2%, preferably 0.8%.

6. The cream according to claim 1, characterized in that, The weight percentage of cetearyl glucoside is 1.0% to 1.5%, the weight percentage of cetearyl alcohol is 1.0% to 2.0%, the weight percentage of caprylic / capric triglyceride is 8.0% to 12%, and the weight percentage of squalane is 7.0% to 9.0%.

7. The cream according to claim 1, characterized in that, The pH value of the multi-target antipruritic and soothing cream is adjusted to 5.0-5.5 by the arginine, and the mass percentage concentration of the arginine is 20%.

8. A method for preparing a multi-target antipruritic and soothing cream for infants as described in any one of claims 1-7, characterized in that, Includes the following steps: S1 Oil phase preparation: Cetearyl glucoside, cetearyl alcohol, caprylic / capric triglyceride, squalane, and perilla seed oil are mixed and heated to 75~85℃ and stirred to dissolve; 4-tert-butylcyclohexanol and menthol lactate are added and stirred until completely dissolved to form the oil phase; S2 Aqueous Phase Preparation: Deionized water and a portion of butanediol are mixed, heated to 75-85°C, and stirred to dissolve, forming the aqueous phase; a portion of the deionized water is reserved for carbomer swelling. S3 Emulsification: Add the oil phase to the aqueous phase and homogenize and emulsify at 75~85℃ and 2000~3000rpm for 10~15 minutes to form an oil-in-water emulsion; S4 Cooling: Cool the emulsion to 40~45℃ with stirring; S5 Low-temperature feeding: Add the hydroxyphenylpropionamide benzoic acid solution pre-dissolved in the remaining butanediol, ectoine, Artemisia argyi extract aqueous solution, panthenol aqueous solution, α-glucan oligosaccharide aqueous solution, and the mixture of raspberry ketone and 1,2-hexanediol in sequence, with an interval of 3-5 minutes between each feeding, and stir at 300-500 rpm for 15-20 minutes. S6 In-situ gelation: Carbomer powder was pre-dispersed in reserved deionized water and swollen at room temperature for 2 hours. It was then added to the above emulsion and stirred at 35-40°C and 300-500 rpm for 20 minutes. Arginine solution was slowly added dropwise to adjust the pH to 5.0-5.

5. S7 Aging: Let stand at room temperature for 12-24 hours to obtain.

9. The preparation method according to claim 8, characterized in that, In S5, hydroxyphenylpropionamide benzoic acid is pre-dissolved in butanediol at a temperature of 40-45°C, and then added after cooling to room temperature.

10. The preparation method according to claim 8, characterized in that, The homogenization emulsification in S3 is performed at a speed of 2500 rpm for 12 minutes.

Images