JP7407269B2 - Skin topical compositions with enhanced anti-eczema efficacy - Google Patents

Description

The present invention provides skin topical compositions with enhanced anti-eczema efficacy comprising: (A) about 1.05 to 8 times, preferably about 1.1 to 4 times, more preferably about 1.2 times; Concentrated birch sap with ~2x concentration, and (B) oat (Avena sativa) grain extract, princepia (Prinsepia Utilis Royle) oil, calendula (Calendula officinalis) extract, allantoin, bisabolol, A skin topical composition comprising one or more active substances selected from the group consisting of ceramides, panthenol, glycerol and squalane.

Eczema is an inflammatory skin disease caused by various internal and external factors, with obvious itching, abnormal skin barrier function, easy recurrence, and an obvious exudative tendency. Of the cosmetics for eczema currently on the market, oat (oat) grain extract, calendula extract, allantoin, bisabolol, ceramides, panthenol, glycerol, squalane, princepia oil and other ingredients are the most common. However, these effects are often unsatisfactory.

Birch is a deciduous tree belonging to the Betulaceae family, and there are currently about 100 species around the world, which are mainly distributed in northern temperate regions and cool temperate regions. Of these, about 29 species exist in China, mainly distributed in the northeast, northwest and southwest. It plays an important role in preventing soil erosion, improving the environment and preventing wind and sand. Birch trees grow primarily in remote, mountainous areas with little human interference and no industrial pollution. Birch sap is fresh sap from cut birch bark or from a drilled trunk. Birch sap is colorless or pale yellow, has no sediment or impurities, and has a slight birch aroma. It is a good nutritional and It has health care effects and is often used to make drinks, alcohol and other beverages. Birch sap contains a large number of compounds, such as sugars, amino acids, vitamins, biotin, cytokinins, trace mineral elements, aromatic oils, betulin and saponins, and has good moisturizing, anti-eczematous and other effectiveness.

In one aspect, the present invention provides a skin topical composition with enhanced anti-eczema efficacy comprising: (A) concentrated birch sap and (B) oat (oat) grain extract, princepia oil, calendula extract; Use of a combination with one or more active substances selected from the group consisting of allantoin, bisabolol, ceramides, panthenol, glycerol and squalane, wherein the concentration of birch sap is about 1.05 to 8 times, preferably about For use with a concentration of 1.1 to 4 times, more preferably about 1.2 to 2 times.

In another aspect, the present invention provides a skin topical composition with enhanced anti-eczema efficacy, comprising: (A) about 1.05 to 8 times, preferably about 1.1 to 4 times, more preferably is concentrated birch sap with a concentration of about 1.2 to 2 times, and (B) oat (oat) grain extract, princepia oil, calendula extract, allantoin, bisabolol, ceramides, panthenol, glycerol and squalane. dermatological topical compositions comprising one or more active substances selected from the group consisting of:

The birch sap involved in the present invention is of the genus Betula, including four varieties of Betula alba, Betula pubescens, Betula Pendula and Betula platyphylla. Ki It is obtained from the family Betula Betulaceae. Birch sap is a colorless, transparent, nutrient-rich product with no precipitants or impurities, obtained by artificial drilling and collection from the base of the birch tree trunk, from the time the snow begins to melt until the time the tree leaves. It is a sap rich in liquid. Birch sap is commercially available and used as is (in this case referred to as original birch fluid), for example from Daxinganling Chaoyue Wild Berry Development Co. , Ltd. It can be purchased from.

Concentrated birch sap according to the present invention is obtained by concentrating the commercially available birch sap concentrate products described above. Concentration methods are known in the art, such as thermal concentration, low temperature and vacuum concentration, and membrane concentration. In the present invention, concentration is preferably performed by low-temperature freeze concentration or membrane concentration. For example, the commercially available birch sap stock solution is introduced into a low temperature drying device, cooled to about -40 to -70 °C, and cooled to about -40 to -70 °C for low temperature and vacuum concentration methods to obtain concentrated birch sap with different concentrations. .Vacuum is applied to 1 to 30 Pa.

Furthermore, the inventors have also discovered that the anti-eczema efficacy of concentrated birch sap does not have a simple linear relationship with its concentration, but initially increases but then decreases with increasing concentration. Therefore, it is important to adjust the concentration of birch sap. In the present invention, the concentration of birch sap is adjusted to about 1.05 to 8 times, preferably about 1.1 to 4 times, more preferably about 1.2 to 2 times.

Surprisingly, we compared the use of concentrated birch sap and oat (oat) grain extract, princepia oil, calendula extract, allantoin, bisabolol, ceramides, panthenol, glycerol or squalane alone. However, the combination of concentrated birch sap, oat (oat) grain extract, princepia oil, calendula extract, allantoin, bisabolol, ceramides, panthenol, glycerol and/or squalane far exceeds these additive effects. They were found to have significantly better anti-eczema efficacy, indicating a synergistic effect between them.

The content of component (A) concentrated birch sap is about 18 to 98% by weight, preferably about 20 to 95% by weight, more preferably about 22 to 90% by weight, based on the total weight of the skin topical composition. , most preferably about 30-90% by weight.

Components (B) oat grain extract, princepia oil, calendula extract, allantoin, bisabolol, ceramides, panthenol, glycerol and squalane are all known in the art and are commercially available.

The content of component (B) is about 0.01 to 10%, preferably 0.1 to 6%, more preferably 0.5 to 5%, based on the total weight of the skin topical composition. .

Dermal topical compositions include pharmaceutical or cosmetic compositions.
The skin topical composition does not further contain any added water, but does not exclude the water inherently contained in each of the components.

In one preferred embodiment, the skin topical composition is free of chelating agents such as EDTA salts, sodium phosphate, sodium metaphosphate and gluconic acid.

In addition to components (A) and (B), the dermal topical composition optionally includes (C) a dermal topical composition, including, but not limited to, a vehicle, an active ingredient, an excipient, and the like. It may contain ingredients commonly used in products. Component (C) is known in the art. Those skilled in the art can select the type and amount as necessary. For example, the total content of component (C) is usually about 2-80% of the total weight of the skin topical composition.

Vehicles include, for example, diluents, dispersants, or carriers. Examples include, but are not limited to, ethanol, dipropylene glycol, butanediol, and the like. The content of vehicle in topical skin compositions is known in the art, for example it is typically about 0.5-20% of the total weight of component (C).

Active ingredients include emollients, humectants, anti-eczema actives, and the like.
Examples of emollients include, but are not limited to, olive oil, macadamia nut oil, sweet almond oil, grape seed oil, avocado oil, corn oil, sesame oil, soybean oil, peanut oil, meadowfoam seed oil, safflower seed oil. oil, rosa canina fruit oil, argania spinosa kernel oil, jojoba (simmondsia chinensis) seed oil, sunflower seed oil, mauritia flexuosa fruit oil, squalane, ethylhexyl palmitate, mil. Isopropyl stinate, hardened poly Isobutylene, isocetane, isododecane, diethylhexyl carbonate, dioctyl carbonate, isopropyl lauroyl sarcosinate, isononyl isononanoate, hardened polydecene, triethylhexanoin, cetyl ethylhexanoate, bis-diethoxydiglycol cyclohexane 1,4-dicarboxylate, One or more of caprylic acid/capric acid triglyceride, oleyl erucate, octyldodecanol myristate, octyldodecanol, polydimethylsiloxane, octylpolymethylsiloxane, cetyl dimethicone, cyclopentadimethylsiloxane, etc. may be mentioned. Examples of solid emollients include, but are not limited to, cetyl alcohol, stearyl alcohol, cetearyl alcohol, behenyl alcohol, squaryl alcohol, lauric acid, myristic acid, palmitic acid, stearic acid, beeswax, candelilla. Wax, carnauba wax, lanolin, ozokerite, jojoba seed wax, paraffin wax, microcrystalline wax, hardened rice bran wax, hardened cocoglyceride, glyceryl behenate/eicosadiate, myristyl myristate, bis-diglyceryl polyacyl adipate. 2, butyrospermum parkii (shea butter), and Astropotassium murumuru seed butter. The content of emollients in skin topical compositions is known in the art, for example it typically ranges from 1 to 50% relative to the total weight of component (C).

Examples of water retention agents include, but are not limited to, glycerin, diglycerin, butylene glycol, propylene glycol, 1,3-propanediol, dipropylene glycol, 1,2-pentanediol, polyethylene glycol-8, polyethylene Glycol-32, Methylgluceth-10, Methylgluceth-20, PEG/PPG-17/6 copolymer, Glycereth-7, Glycereth-26, Glyceryl glucoside, PPG-10 Methylglucose ether, PPG-20 Methylglucose ether, PEG/PPG/ Polybutylene glycol-8/5/3 glycerol, sucrose, trehalose, rhamnose, mannose, raffinose, betaine, erythritol, xylitol, urea, glycereth-5-lactate, sodium hyaluronate, hydrolyzed sodium hyaluronate, acetylated sodium hyaluronate, One or more of sodium polyglutamate, hydrolyzed sclerotium gum, pullulan, tremellam, tamarind seed polysaccharide, 1,2-hexanediol, natural humectant, ceramide 2, ceramide 3, cholesterol, phospholipid, etc. There are multiple examples. The content of water retention agents in skin topical compositions is known in the art, for example it is typically about 1-30% of the total weight of component (C).

Examples of anti-eczema active ingredients include, but are not limited to, dipotassium glycyrrhizinate, PORTULACA OLERACEA extract, biological sugar gum-1, β-glucans, fructans. , SCUTELLARIA BAICALENSIS root extract, AESCULUS HIPPOCASTANUM extract, 4-tert-butylcyclohexanol, ceramide 3, Spanish licorice (GLYCYRRHIZA GLABRA) extract, hydrolyzed royal jelly protein, oryzanol, phytosphingosine, Examples include one or more of quercetin, ginger root extract, rosemary leaf extract, and the like. The content of anti-eczema active ingredients in skin topical compositions is known in the art, for example it is usually about 0.01-10% of the total weight of component (C).

Examples of excipients include emulsifiers, thickeners, preservatives, fragrances, and the like.
Examples of emulsifiers include, but are not limited to, cetearyl olive oil fatty acid, sorbitan olive oil fatty acid, polysorbate-60, polysorbate-80, methylglucose sesquistearate, PEG-20 methylglucose sesquistearate, PEG-40. Hydrogenated castor oil, PPG-26-buteth-26, PEG-4 polyglyceryl-2 stearate, PEG-60 hydrogenated castor oil, steareth-2, steareth-21, PPG-13-decyltetradeceth-24, cetearyl glucoside , PEG-100 stearate, glyceryl stearate, glyceryl stearate SE, cocoglucoside, ceteareth-25, PEG-40 stearate, polyglyceryl distearate-3 methylglucose, glyceryl stearate citrate, polyglyceryl stearate-10, myristicin Polyglyceryl-10 acid, polyglyceryl-10 dioleate, polyglyceryl-10 laurate, polyglyceryl-10 isostearate, polyglyceryl-10 oleate, polyglyceryl-10 diisostearate, polyglyceryl-6 laurate, polyglyceryl-6 myristate, sucrose stearate. and one or more of sucrose polystearate. The content of emulsifiers in skin topical compositions is known in the art, for example it is typically 0.5-10% of the total weight of component (C).

Examples of thickeners include, but are not limited to, high molecular weight polymers such as carbomers, acrylates and their derivatives, xanthan gum, gum arabic, polyethylene glycol-14M, polyethylene glycol-90M, succinyl polysaccharide, hydroxyethyl cellulose, hydroxy One or more of propylcellulose and hydroxypropylmethylcellulose are included. The content of thickeners in skin topical compositions is known in the art, for example it is typically from 0.1 to 10% of the total weight of component (C).

Examples of preservatives include, but are not limited to, methyl hydroxybenzoate, propyl hydroxybenzoate, phenoxyethanol, benzyl alcohol, phenylethanol, bis(hydroxymethyl)imidazolidinyl urea, potassium sorbate, sodium benzoate, chloro Chlorophenesin, sodium dehydroacetate, caprylic hydroxamic acid, 1,2-hexanediol, 1,2-pentanediol, p-hydroxyacetophenone, caprylyl glycol, glyceryl caprylate, glyceryl undecylenate, sorbitan caprylate, ethylhexyl Examples include one or more of glycerol, peony root extract, and the like. The content of preservatives in skin topical compositions is known in the art, for example it typically ranges from 0.01 to 2% of the total weight of component (C).

Skin topical compositions with enhanced anti-eczema efficacy according to the present invention can be prepared by any suitable method known in the art. For example, it can be prepared using devices commonly used in the cosmetics field, such as dissolution tanks, emulsification pots, dispersers, transfer pumps, etc. During preparation, water-soluble substances are charged into a water-phase dissolution kettle, oil-soluble substances are charged into an oil-phase dissolution kettle, and the two kettles are heated to approximately 80°C, respectively.For raw materials that easily aggregate, dispersion It can be dispersed in advance using a machine. Once dissolution is complete, transfer the oil and water phases to an emulsification pot and homogenize and emulsify for approximately 5-15 minutes. Once emulsification is complete, the bulk is cooled to room temperature, optionally fragrances, preservatives, etc. are added, and the pH of the product is adjusted as necessary.

The above preparation methods can be modified or adjusted depending on the requirements of the dosage form. The skin topical compositions of the present invention can be formulated into various dosage forms, such as ointments, creams, emulsions, lotions, essences, sprays, and gels, as desired.

The invention will be explained in more detail below with reference to examples. However, it should be understood that these Examples and Comparative Examples are used only to specifically illustrate the present invention and do not in any way constitute the scope of the appended claims of the present invention. It should not be understood as limiting the scope.

Example 1: Expression of genes related to moisturization and barrier repair in different material systems In this example, oat ( The effect of combining oat) grain extract or calendula extract with birch sap was investigated.

The experimental method was as follows:
1. Experimental equipment: Fluorescence quantitative PCR instrument (Roche), clean bench (Su Jing), CO ₂ incubator (Binder), microplate reader (BIO-TEK), microoscillator.

2. Experimental reagents and materials: keratinocytes, 6-well culture plates, cell culture medium, RNA extraction kit, reverse transcription kit, Trizol lysis solution, etc.

3. The steps for keratinocyte-based gene expression analysis were as follows:
(1) Inoculation: Cells were seeded into 6-well plates at a density of 2E5 cells/well and incubated overnight at 37°C in an incubator containing 5% _CO2 ;
(2) Formulations: Specific test formulations are shown in the table below:

(3) Administration: When the cell seeding rate in the 6-well plate reached approximately 50%, the test substances of each group were added, and four replicate wells were prepared for each group of test substances;
(4) Sample collection: After inoculating for 24 hours at 37 °C in an incubator containing 5% _CO2 , discard the culture medium, add 1 mL of Trizol to each well, lyse the cells, and then collect the samples. did;
(5) PCR detection: RNA was extracted, reverse transcribed into cDNA, and detected by fluorescence quantitative PCR;
(6) Analysis: Results were calculated using the 2 ^-ΔΔCT method and the T-test method was used for statistical analysis. The results obtained are shown in the table below.

1.2 times, 4 times and 9 times concentrated birch sap were obtained by concentrating the birch sap stock solution. The concentration method was as follows: Daxinganling Chaoyue Wild Berry Development Co. , Ltd. Fresh birch (Betula alba) sap stock solution purchased from was fed into a low-temperature drying device, cooled to -65 °C, vacuumed to 0.1 Pa, and concentrated by 1.2 times, 4 times, and 9 times, respectively. .

The results in Table 1 show that the combination of oat grain extract or calendula extract with birch sap can improve the expression of genes related to moisturization and barrier repair, such as keratinocyte transglutaminase TGM1, epidermal tight junction protein (ZO- 1 and CLDN1), filaggrin FLG and aquaporin AQP3 were shown to significantly increase. Furthermore, compared to birch sap stock solution, the combination with 1.2 times concentrated birch sap showed better efficacy.

Example 2: Effect of birch sap on the expression of proteins associated with moisturization and barrier repair. investigated the effects of combining allantoin or bisabolol with birch sap.

The experimental method was as follows:
1. Experimental equipment: clean bench (Su Jing), microplate washer (BIO-RAD), microplate reader (BIO-TEK), CO ₂ incubator (Binder).

2. Experimental reagents and materials: human primary keratinocytes, 12-well culture plates, culture medium for keratinocytes, ELISA kits for various indicators, etc.

3. The test steps were as follows:
(1) Inoculation: Cells were seeded into 12-well culture plates at a density of 2E5 cells/well and incubated at 37°C in an incubator containing 5% _CO2 , and the culture medium was changed every 2 days;
(2) Administration: When cell fusion reached more than 60% again, different concentrations of test substances were added, six replicate wells were prepared for each group of test substances, and the formulation was as follows:

(3) Sample collection: After inoculation for 48 hours at 37 °C in an incubator containing 5% _CO2 , discard the culture medium, add 1 mL of Trizol to each well, lyse the cells, and then collect the samples. did;
(4) Detection: The index was determined according to the determination method of the ELISA kit.

(5) Analysis: T-test method was used for statistical analysis. The results of the test are shown in the table below.

The results in the table above demonstrate that the combination of allantoin or bisabolol with birch sap significantly increases the expression of proteins related to moisturization and barrier repair, such as keratinocyte transglutaminase TGM1, epidermal tight junction proteins (ZO-1 and CLDN1), filaggrin FLG and It was shown to significantly increase aquaporin AQP3. Furthermore, compared to birch sap stock solution, the combination with 1.2 times concentrated birch sap showed better efficacy.

Example 3: Effect of birch sap on keratinocyte proliferation and differentiation In this example, the effect of a combination of ceramide or glycerol and birch sap on keratinocyte proliferation and differentiation was tested and compared.

The experimental method was as follows.
1. Cells: HACAT (human immortalized epidermal keratinocytes).

2. Experimental equipment and materials: 96-well plate, 1 ml pipette, 5 ml pipette, 1 ml pipette tip, 5 ml pipette tip, 15 ml centrifuge tube, cell counter, 0.22 μm filter, fin pipette, fin pipette slot, DMEM cell culture medium, FBS, 100x tertiary antibody, 100x mycoplasma inhibitor, CCK-8 reagent.

3. The experimental steps were as follows:
(1) Cultured HACAT cells were seeded in 96-well plates at a cell density of 3000 cells/well, 100 ul per well;
(2) Cultured for 24 hours at 37°C in an incubator containing 5% _CO2 ;
(3) Administered in 100ul/well, the formulation was as follows:

(4) After 72 hours of incubation, the supernatant was discarded and 100 ul of medium containing 10% CCK-8 was added to each well;
(5) Incubated at 37°C for 2 hours, then the OD value was detected at 450 nm by a microplate reader;
The above experiment was conducted in three parallel groups. Cells were derived from three culture flasks, and cell counts and experimental manipulations were performed independently. The results obtained are shown in the table below.

The results in the table above showed that the combination of ceramide or glycerol with birch sap significantly increased the proliferation and differentiation of keratinocytes. Furthermore, compared to birch sap stock solution, the combination with 1.2 times concentrated birch sap showed better efficacy.

Example 4: Effect of birch sap on mast cell degranulation In this example, the effect of the combination of birch sap with panthenol or squalane on mast cell degranulation was investigated using a young zebrafish allergy model. tested and compared.

The experimental method was as follows.
1. Experimental animal: zebrafish.

2. The experimental steps were as follows: AB wild-type zebrafish embryos were collected and cultured with E3 buffer in an incubator at 28.5 °C until 5 dpf (days post fertilization), changing the buffer daily; Zebrafish of 5 dpf were randomly transferred into 48-well cell culture plates in groups of 10 fish per well, 4 replicate wells per group, in groups as follows:
Model group: RO water + 15μg/ml SP
Positive group: Ketotifen + 15μg/ml SP
Sample groups tested: The formulation was as follows:

Corresponding to the above degranulation group with SP, a negative control group without SP was established with four replicate wells per group, and a degranulation group with SP introduced and a negative control group without SP. Correspondingly, a background control group (no zebrafish larvae) was established with two replicate wells per group. The remaining E3 buffer in the wells of each group was absorbed, 250 μl of the solution corresponding to each group was added, and the reaction was carried out in the dark in an incubator at 28.5° C. for 60 minutes. After 60 minutes, 200 μl of supernatant of each group was placed in a 96-well cell culture plate, and the enzyme reaction substrate BAPNA was added respectively to achieve a concentration of 400 μg/ml. The 96-well plate was covered in the dark, placed in a 28.5°C incubator, and allowed to react for 2 hours. All plates were measured after 2 hours for light absorption values at 405 nm, which reflect tryptase release in zebrafish mast cells.

The experimental results of the zebrafish young mast cell protection model are recorded in the table below.

The results in the table above showed that the combination of panthenol or squalane with birch sap significantly inhibited mast cell degranulation. Furthermore, compared to birch sap stock solution, the combination with 1.2 times concentrated birch sap showed better efficacy.

Example 5: Effect of birch sap on the production of inflammatory factors in the development of eczema In this example, 2,4-dinitrofluorobenzene (DNFB) was used to sensitize and promote the establishment of a murine eczema model, Hydrocortisone ointment was given as a positive control to investigate the effect of oat (oat) grain extract or the combination of princepia oil and birch sap on the production of inflammatory factors Th2 (IL-4, 13, 17) and TSLP.

The experimental method was as follows:
1. Experimental animal: ICR mouse, male.

2. Experimental materials: 0.5% DNFB acetone solution, hair removal cream, dust mite extract, birch tree sap, oat (oat) grain extract, princepia oil.

3. The experimental steps were as follows: ICR mice were randomly divided into groups according to body weight with 12 mice in each group, and divided into normal group, model group and sample group. For experimental mice in each group, one day before modeling, hair in an area of approximately 2 ^* 2 cm on the back of the mice was removed using depilatory cream. The area of the experiment was determined on the back of the mouse, and the stratum corneum was removed by applying Scotch tape 8 times. Then, in the first week, all experimental animals were sensitized by injection of dust mite extract on days 1, 3, 5 and 7. In the second week of the experiment, on days 10 and 13, we injected dust mite extract for sensitization, and in the third to sixth weeks of the experiment, we injected dust mite extract once a week for sensitization. injection and an acetone patch was used for induction. Acetone (DNCB) was diluted to a 0.5% acetone solution using double distilled water. Mice were exposed to 0.5% DNCB once every other day in the second week with 100 μl each time and from the second week onwards with 70 μl every other day. Sensitization was continued for 6 weeks.

After 12 hours of successful modeling, birch sap with different concentrations was sprayed uniformly on the backs of the experimental mice using an aerosol bottle three times a day for 7 consecutive days. The model group was sprayed with distilled water three times a day for 7 consecutive days.

The formulation of the test sample was as follows:

4. Test indicators: After 7 days of treatment, mouse serum was collected and the content of mouse serum inflammatory factors TSLP and Th2 (IL-4, 13, 17) was detected using ELISA kit. The results obtained are shown in the table below.

The results in the table above showed that the combination of oat (oat) grain extract or princepia oil and birch sap exhibited significant anti-eczema efficacy. Furthermore, compared to birch sap stock solution, the combination with 1.2 times concentrated birch sap showed better efficacy.

Example 6: Anti-eczematous facial cream composition The formulation of the anti-eczematous facial cream composition was as follows:

An anti-eczema facial cream composition was prepared as follows:
1. Raw material 4 was uniformly dispersed together with raw material 11;
2. Raw material 7 was heated and dissolved by raw material 10;
3. Raw materials 1 and 25 are charged into an aqueous phase pot and dispersed together with raw material 12 while stirring, and after raw material 12 is completely dissolved, raw materials 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 are added. and 25 were added and heated to a maximum of 80°C;
4. Raw materials 13, 14, 15, 16, 17, 18, 19, 20, 21, and 22 were charged into an oil phase pot and heated to 80°C;
5. The raw materials in the aqueous phase pot were pumped into the emulsification pot and homogenized at high speed for 5 minutes;
6. Pump the raw material in the oil phase pot into the emulsification pot, homogenize at high speed for 5 minutes, and hold for 10 minutes;
7. Cooled to 50° C. with stirring, charged raw materials 23 and 24, and slowly homogenized for 3 minutes;
8. Cooled to 40°C with stirring;
9. The product was tested before discharge.

In this example, 12 children with mild eczema and 12 children with moderate eczema, aged 3-15 years, were selected for 3 weeks of treatment. Among them, 6 children with mild eczema and 6 with moderate eczema were treated with anti-eczematous facial cream applied 2-3 times a day at 100-200 g each time, and the remaining patients , treated with a skin care cream without birch sap (control product, formulation exactly as described in the table above, but with all birch sap replaced by water) for 3 consecutive weeks to determine the severity of the disease. Degrees were scored on day 14.

The results showed that the anti-eczema facial cream significantly improved skin condition (p<0.05) and even more significantly (p<0.01) at 21 days compared to the control product. Indicated. This indicates that the anti-eczema facial cream can treat mild to moderate eczema.

Example 7: Anti-eczema extract composition The formulation of the anti-eczema extract composition was as follows:

An anti-eczema extract composition was prepared as follows:
1. Raw material 3 was uniformly dispersed together with raw material 11;
2. Raw material 1 is charged into an emulsification pot, raw materials 14 and 15 are dispersed while stirring, and after raw materials 14 and 15 are completely expanded, raw materials 2, 3, 4, 5, 6, 7, 8, 9, 10, Add 11, 12 and 13, heat up to 80°C with stirring, homogenize at high speed for 5 minutes and hold for 10 minutes;
3. Cooled to 50° C. with stirring, added raw materials 16, 17 and 18, and homogenized at high speed for 5 minutes;
4. Cooled to 50°C with stirring and added raw materials 19 and 20;
5. Cooled to 40°C with stirring;
6. The product was tested before discharge.

In this example, 12 children with mild eczema and 12 children with moderate eczema, aged 3-15 years, were selected for 3 weeks of treatment. Among them, 6 children with mild eczema and 6 with moderate eczema were treated with anti-eczema extract applied 2-3 times a day at 100-200 g each time, and the remaining patients were treated with birch extract. Treatment with extract without sap (control product, formulation was exactly as described in the table above, but all birch sap was replaced with water) for 3 consecutive weeks reduced the severity of the disease by 14 Scored on the day.

The results showed that the anti-eczema extract significantly improved the skin condition (p<0.05) and even more significantly (p<0.01) at 21 days compared to the control product. . This indicates that the anti-eczema extract can treat mild to moderate eczema.

Example 8: Anti-eczema lotion composition The formulation of the anti-eczema lotion composition was as follows:

An anti-eczema lotion composition was prepared as follows:
1. Raw material 4 was uniformly dispersed together with raw material 9;
2. Raw material 1 was charged into an emulsification pot, and raw material 11 was dispersed while stirring. After raw material 11 was completely expanded, raw materials 2, 3, 4, 5, 6, 7, 8, 9, and 10 were added.

3. Heat to 80° C. with stirring, homogenize at high speed for 5 minutes, and hold for 10 minutes.
4. Added raw material 12, homogenized at high speed for 5 minutes and held for 10 minutes.

5. The mixture was cooled to 60° C. with stirring, and raw material 13 was added.
6. Cooled to 50°C, added raw materials 14 and 15, and slowly homogenized for 3 minutes.

7. Cooled to 40°C with stirring;
8. The product was tested before discharge.

In this example, 12 children with mild eczema and 12 children with moderate eczema, aged 3-15 years, were selected for 3 weeks of treatment. Of them, 6 children with mild eczema and 6 with moderate eczema were treated with anti-eczema lotion applied 2-3 times a day at 100-200 g each time, and the remaining patients were treated with birch Treatment with an emulsion without sap (control product, formulation exactly as described in the table above, but all concentrated birch sap was replaced with birch sap concentrate) for 3 consecutive weeks, and the severity of the disease Degrees were scored on day 14.

The results showed that the anti-eczema lotion significantly improved the skin condition (p<0.05) and even more significantly (p<0.01) at day 21 compared to the control product. . This indicates that the anti-eczema lotion can treat mild to moderate eczema.

Example 9: Anti-eczema ointment The formulation of the anti-eczema ointment was as follows:

An anti-eczema ointment was prepared as follows:
1. Raw material 3 and raw material 8 were uniformly dispersed.

2. Raw material 5 was dissolved with raw material 6.
3. Raw material 1 was placed in a water phase pot, and raw materials 2, 3, 4, 6, 7 and 8 were added with stirring and heated to 80°C.

4. Raw materials 9, 10, 11, 12, 13, 14, 15, 16, and 17 were charged into an oil phase pot and heated to 80°C.

5. The raw materials in the aqueous phase pot were pumped into the emulsification pot and homogenized at high speed for 5 minutes.
6. The raw material in the oil phase pot was pumped into the emulsification pot, homogenized at high speed for 5 minutes, and held for 10 minutes.

7. The mixture was cooled to 50° C. with stirring, and raw materials 5, 19 and 18 were charged and slowly homogenized for 3 minutes.

8. The mixture was cooled to 40° C. while stirring.
9. The product was tested before discharge.

In this example, 12 children with mild eczema and 12 children with moderate eczema, aged 3-15 years, were selected for 3 weeks of treatment. Of them, 6 children with mild eczema and 6 with moderate eczema were treated with an anti-eczema ointment applied twice daily, and the remaining patients were treated with an ointment without birch sap (control product , the formulation was exactly as described in the table above, but all the birch sap was replaced with water) for 3 consecutive weeks and the severity of the disease was scored on the 7th day.

The results showed that the anti-eczema ointment significantly improved the skin condition (p<0.05) and even more significantly (p<0.01) at day 14 compared to the control product. . This indicates that the anti-eczema ointment can treat mild to moderate eczema.

The technical solutions of the above examples were preferred embodiments of the present invention. Several improvements and changes can be made without departing from the principles of the invention, and these improvements and changes should also be considered to fall within the protection scope of the invention.

Claims (8)

A skin topical composition having anti-eczema efficacy, the composition comprising:
(A) concentrated birch sap with a concentration of 1.2 to 8 times and (B) oat grain extract, princepia oil, calendula extract, allantoin, bisabolol, ceramides, panthenol, glycerol and squalane. one or more active substances selected from the group consisting of ;
A skin topical composition that does not further contain any added water. The skin topical composition of claim 1 , wherein the concentrated birch sap has a concentration of 1.2 to 4 times . The skin topical composition of claim 2 , wherein the concentrated birch sap has a concentration of 1.2 to 2 times . The skin topical composition according to claim 1, wherein the content of the component (A) concentrated birch sap is 18 to 98% by weight based on the total weight of the skin topical composition . The skin topical composition according to claim 1 , wherein the content of the component (B) is 0.01 to 10% based on the total weight of the skin topical composition. The content of the component (B) is 0.5% based on the total weight of the skin topical composition. A skin topical composition according to claim 5 , wherein the skin topical composition is from 1 to 6% . The skin topical composition according to claim 6 , wherein the content of the component (B) is 0.5 to 5% based on the total weight of the skin topical composition. 8. A topical skin composition according to any one of claims 1 to 7, wherein said topical skin composition is a pharmaceutical composition or a cosmetic composition.