CN113350262B

CN113350262B - Skin cream suitable for atopic dermatitis of children

Info

Publication number: CN113350262B
Application number: CN202110734891.3A
Authority: CN
Inventors: 刘影
Original assignee: Chayan Biotechnology Co ltd
Current assignee: Chunyan Biotechnology Co ltd
Priority date: 2021-06-30
Filing date: 2021-06-30
Publication date: 2022-09-16
Anticipated expiration: 2041-06-30
Also published as: CN113350262A

Abstract

The invention provides a body lotion suitable for atopic dermatitis of children, which is prepared by firstly applying a lactobacillus fermentation product to a body lotion cosmetic for the auxiliary treatment of the atopic dermatitis of children, and then assisting allantoin, an oat extract, ceramide, phytosterol, fatty acid, glycyrrhizic acid, glycyrrhetate, hesperidin, grease and a humectant, has obvious curative effect on the atopic dermatitis, can adjust the micro-ecological environment of skin, and improve the phenomena of severe skin pruritus, dry skin and the like. The moisturizer can be used for assisting in treating the atopic dermatitis of children, reducing the dosage of the treatment hormone and effectively relieving the stimulation brought by the treatment hormone.

Description

Skin cream suitable for atopic dermatitis of children

Technical Field

The invention relates to the field of skin care products for children, in particular to a body lotion suitable for atopic dermatitis of children.

Background

Atopic Dermatitis (AD) is a chronic, recurrent, inflammatory skin disease that is clinically common and is characterized primarily by severe itching, chronic eczematous Dermatitis, dry skin and recurrent episodes. Clinically, the skin disease can be divided into a infancy stage (birth to 2 years), a childhood stage (2 to 12 years), a juvenile stage and an adult stage (>12 years), is primarily developed in the infancy stage, is mostly seen in children and adolescence stages, and is affected by AD in 15 to 30 percent of children and 2 to 10 percent of adults in the world, so that the skin disease is the most common chronic skin disease of children. In recent years, there is a gradually increasing tendency of prevalence of atopic dermatitis worldwide, which may cause recurrent skin itching symptoms, seriously affect the quality of work and life of patients, and bring great mental and economic burdens to patients and their families.

Natural or synthetic immunosuppressants, antihistamines, steroids and other therapeutic agents have been developed for the causes, mechanisms and symptoms of atopic dermatitis, but long-term administration to children patients results in inhibition of growth and thus may cause local and systemic side effects, so that the current treatment method for AD in children at home and abroad is skin cleansing care and moisturizing, which is the basic treatment of AD, and topical glucocorticoid is the first-line medication, and the two are often combined in practice.

In 2019, in 7 th of the journal of Chinese dermatology, the research result of auxiliary effect of moisturizing emollient in treatment of moderate and severe atopic dermatitis in children, written by Lutan et al, shows that the dosage of glucocorticoid is reduced by 42-46% when the moderate and severe atopic dermatitis in children is treated by combining glucocorticoid with moisturizing emollient for 4 weeks.

The application guide of the effective skin care product in the atopic dermatitis of children, which is written by Wangshan and the like and recorded in the 9 th stage of Chinese journal of skin diseases in 2020, shows that the application of the effective skin care product in the atopic dermatitis of children can repair the barrier function of skin, reduce the use of external hormone medicines and reduce the relapse risk of AD, and discloses the effect of the effective components on AD, but the effective skin care product suitable for the atopic dermatitis of children is not researched.

Chinese patent CN103228287A composition for preventing or treating atopic dermatitis comprising herbal extract or lactobacillus fermented product thereof discloses that herbal extract or lactobacillus fermented product composition thereof which can be used in cosmetics can improve or treat atopic dermatitis, which indicates that the herbal ingredients improve or treat atopic dermatitis, but children have tender skin, strong absorption capacity, and immature immune system and skin barrier system, and the herbal ingredients are liable to cause allergy during use.

Therefore, it is a problem to be solved how to develop a skin care product which is effective for adjuvant therapy of atopic dermatitis in children and safe.

Disclosure of Invention

In view of the above problems, the present inventors have developed a moisturizer suitable for children's atopic dermatitis.

The invention relates to a body lotion suitable for children atopic dermatitis, which comprises the following raw materials in parts by weight: 17.1-37.4 parts of grease, 0.6-3 parts of ceramide, 0.2-1 part of phytosterol, 0.2-1 part of fatty acid, 0.8-2 parts of lactobacillus fermentation product, 0.1-0.5 part of allantoin, 0.6-1.4 parts of oat extract, 0.4-0.7 part of hesperidin, 0.2-0.4 part of glycyrrhizic acid, 0.3-0.7 part of glycyrrhetate, 1-5 parts of cetearyl alcohol, 1.5-5.5 parts of emulsifier, 5.8-10.3 parts of humectant, 0.2-2 parts of thickener and 0.1-0.5 part of preservative.

Further, the grease comprises 2-5 parts of coconut oil, 1-2 parts of shea butter, 0.5-2 parts of olive oil, 0.3-0.8 part of squalane, 0.3-1.6 parts of jojoba seed oil, 5-12 parts of vaseline and 8-14 parts of white oil.

Further, the fatty acid is at least one of lauric acid, arachidonic acid and myristic acid.

Further, the preparation method of the lactobacillus fermentation product comprises the steps of inoculating lactobacillus rhamnosus (L.rhamnosus), Streptococcus thermophilus (Streptococcus thermophilus) and lactobacillus casei (L.casei) into a fermentation medium, fermenting at 37 +/-2 ℃ for 24-26 hours, adding fucus powder accounting for 1-4% of the weight of the fermentation medium, continuing to ferment for 24-36 hours, filtering, adding sodium chloride into filtrate, standing for 5-6 hours, centrifuging at 2000-4000 rpm for 5-8 minutes, discarding supernatant, drying and precipitating to obtain the lactobacillus fermentation product.

Further, the fermentation medium may be any of various conventional media capable of fermentatively culturing lactobacillus rhamnosus, streptococcus thermophilus, and lactobacillus casei.

Further, the emulsifier comprises 1-2.5 parts of glucoside and 0.5-3 parts of polyglycerol.

Further, the humectant comprises 50.6-1.3 parts of provitamin B, 5-8 parts of glycerol, 0.1-0.5 part of hyaluronic acid and 0.1-0.5 part of sodium alginate.

Further, the thickening agent is at least one of xanthan gum, hydroxyethyl cellulose, carbomer, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, acrylic acid (ester)/C10-30 alkanol acrylate cross-linked polymer and ammonium acryloyldimethyl taurate/VP copolymer.

The preparation process of the moisturizer suitable for the atopic dermatitis of children comprises the following steps of:

s1, grinding oat into powder, adding water with the mass being 12-15 times that of the oat, standing for 10-15 min at the temperature of 40-60 ℃ and under the condition of oscillation frequency of 150-160 rpm, performing microwave extraction at the temperature of 80-95 ℃ for 5-10 min, filtering with a microporous filter membrane, and collecting filtrate to obtain an oat extract;

s2, mixing the grease, the emulsifier, the hesperidin and the cetostearyl alcohol, and heating to 70-80 ℃ to obtain a phase A;

s3, mixing the moisturizing agent and the thickening agent, heating to 70-80 ℃, and mixing and homogenizing with the phase A to obtain a phase B;

and S4, cooling the phase B to 40-45 ℃, adding ceramide, phytosterol, fatty acid, a lactic acid bacteria fermentation product, allantoin, an oat extract, glycyrrhizic acid, glycyrrhetate and a preservative, uniformly mixing, and cooling to room temperature to obtain the body lotion suitable for children atopic dermatitis.

Further, in step S3, the stirring speed for homogenization is 900-1500 r/min, and the time is 10-15 min.

Further, in step S4, the uniformly mixing is performed by stirring and mixing while adding, and stirring is performed for 10-15 min.

Compared with the prior art, the invention has the beneficial effects that:

according to the invention, the lactobacillus fermentation product is applied to the skin-moistening cosmetics for the adjuvant treatment of the atopic dermatitis of children for the first time, and the allantoin, the oat extract, the ceramide, the phytosterol, the fatty acid, the glycyrrhizic acid, the glycyrrhetate, the hesperidin, the grease and the humectant are added, so that the skin-moistening cream has a remarkable curative effect on the atopic dermatitis, can adjust the micro-ecological environment of the skin, and can improve the phenomena of severe pruritus, dry skin and the like. The moisturizer can be used for assisting in treating the atopic dermatitis of children, reducing the dosage of the treatment hormone and effectively relieving the stimulation brought by the treatment hormone.

The coconut oil, the shea butter, the olive fruit oil, the squalane, the jojoba seed oil, the vaseline and the white oil are blended into the grease composition, the ratio of the components is adjusted, the oleic acid is balanced, the water retention capacity of the skin is enhanced, and the moisture content of the stratum corneum of the skin can be increased and the dry and rough conditions of the skin can be improved by matching the components of the humectant.

The prepared lactobacillus fermentation product and the oat extract can penetrate into the basal layer of the skin to repair basal cells, glycyrrhizic acid, glycyrrhetate, allantoin and hesperidin are used in a matching manner to inhibit lipid peroxidation, promote the synthesis of natural moisturizing factors and improve the micro-ecological environment of the skin, so that the skin pruritus condition is improved, and then the water content of the skin is increased, the keratinocyte differentiation is promoted, and the stable function of a skin barrier and the micro-ecological environment of the skin are maintained through ceramide, phytosterol, fatty acid and a humectant.

Detailed Description

In order to better understand the technical content of the invention, specific examples are provided below to further illustrate the invention.

The experimental methods used in the examples of the present invention are all conventional methods unless otherwise specified.

The materials, reagents and the like used in the examples of the present invention can be obtained commercially without specific description.

The units of parts by weight in the following embodiments are g or kg.

Example 1

The skin cream suitable for children atopic dermatitis comprises the following raw materials in parts by weight: 2 parts of coconut oil, 1 part of shea butter, 0.5 part of olive oil, 0.8 part of squalane, 1.6 parts of jojoba seed oil, 5 parts of vaseline, 8 parts of white oil, 0.6 part of ceramide, 0.2 part of phytosterol, 0.2 part of arachidonic acid, 2 parts of lactobacillus fermentation product, 0.5 part of allantoin, 0.6 part of oat extract, 0.4 part of hesperidin, 0.2 part of glycyrrhizic acid, 0.7 part of glycyrrhetate, 3 parts of cetostearyl alcohol, 1.0 part of glucoside, 0.5 part of polyglycerol, 50.6 parts of provitamin B, 5 parts of glycerol, 0.1 part of hyaluronic acid, 0.1 part of sodium alginate, 2 parts of xanthan gum and 0.5 part of preservative.

The preparation method of the lactobacillus fermentation product comprises the steps of inoculating lactobacillus rhamnosus, streptococcus thermophilus and lactobacillus casei into a fermentation medium, fermenting for 24 hours at 37 +/-2 ℃, adding fucus powder accounting for 2% of the weight of the fermentation medium, continuing to ferment for 24 hours, filtering, adding sodium chloride accounting for 1.5% of the weight of filtrate into the filtrate, standing for 6 hours, centrifuging at 2000rpm for 8 minutes, removing supernatant, and drying and precipitating to obtain the lactobacillus fermentation product.

The number ratio of the lactobacillus rhamnosus, the streptococcus thermophilus and the lactobacillus casei is 1:0.3:0.8, and the total inoculation amount of the lactobacillus rhamnosus, the streptococcus thermophilus and the lactobacillus casei is 2% (v/v) of a fermentation medium.

A method for preparing a moisturizer suitable for children atopic dermatitis comprises the following steps:

s1, grinding oat into powder, adding water with the mass 15 times that of the oat, standing for 15min at the temperature of 55 ℃ and the oscillation frequency of 150rpm, performing microwave extraction at the temperature of 80 ℃ for 10min, filtering by using a microporous filter membrane, and collecting filtrate to obtain an oat extract;

s2, mixing coconut oil, shea butter, olive fruit oil, squalane, jojoba seed oil, vaseline, white oil, glucoside, polyglycerol, hesperidin and cetostearyl alcohol, and heating to 75 ℃ to obtain a phase A;

s3, mixing provitamin B5, glycerol, hyaluronic acid, sodium alginate and xanthan gum, heating to 70 ℃, mixing with the phase A, and homogenizing at a stirring speed of 1000r/min for 12min to obtain a phase B;

s4, cooling the phase B to 40 ℃, adding ceramide, phytosterol, arachidonic acid, a lactic acid bacteria fermentation product, allantoin, an oat extract, glycyrrhizic acid, glycyrrhetate and a preservative, stirring and mixing while adding, stirring for 12min, and cooling to room temperature to obtain the skin cream suitable for children atopic dermatitis.

Example 2

The skin cream suitable for atopic dermatitis of children comprises the following raw materials in parts by weight: 3 parts of coconut oil, 2 parts of shea butter, 1.5 parts of olive oil, 0.5 part of squalane, 1.2 parts of jojoba seed oil, 8 parts of vaseline, 10 parts of white oil, 1.4 parts of ceramide, 0.6 part of phytosterol, 0.4 part of lauric acid, 1.8 parts of lactobacillus fermentation product, 0.2 part of allantoin, 0.9 part of oat extract, 0.5 part of hesperidin, 0.3 part of glycyrrhizic acid, 0.5 part of glycyrrhetate, 5 parts of cetostearyl alcohol, 2.5 parts of glucoside, 2.2 parts of polyglycerol, 50.8 parts of provitamin B, 6 parts of glycerol, 0.3 part of hyaluronic acid, 0.2 part of sodium alginate, 1.5 parts of carbomer and 0.2 part of preservative.

The preparation method of the lactobacillus fermentation product comprises the steps of inoculating lactobacillus rhamnosus, streptococcus thermophilus and lactobacillus casei into a fermentation medium, fermenting for 25 hours at 37 +/-2 ℃, adding fucus powder accounting for 4% of the weight of the fermentation medium, continuing to ferment for 36 hours, filtering, adding sodium chloride accounting for 1.5% of the weight of filtrate into the filtrate, standing for 5 hours, centrifuging for 5 minutes at 4000rpm, removing supernatant, and drying and precipitating to obtain the lactobacillus fermentation product.

The quantity ratio of the lactobacillus rhamnosus, the streptococcus thermophilus and the lactobacillus casei is 1:0.5:0.5, and the total inoculation quantity of the lactobacillus rhamnosus, the streptococcus thermophilus and the lactobacillus casei is 2% (v/v) of a fermentation medium.

Example 3

The skin cream suitable for children atopic dermatitis comprises the following raw materials in parts by weight: 3 parts of coconut oil, 2 parts of shea butter, 1.5 parts of olive oil, 0.5 part of squalane, 1.2 parts of jojoba seed oil, 8 parts of vaseline, 10 parts of white oil, 1.4 parts of ceramide, 0.6 part of phytosterol, 0.4 part of lauric acid, 1.8 parts of lactobacillus fermentation product, 0.2 part of allantoin, 0.9 part of oat extract, 0.5 part of hesperidin, 0.3 part of glycyrrhizic acid, 0.5 part of glycyrrhetate, 5 parts of cetostearyl alcohol, 2.5 parts of glucoside, 2.2 parts of polyglycerol, 50.8 parts of provitamin B, 6 parts of glycerol, 0.3 part of hyaluronic acid, 0.2 part of sodium alginate, 1.5 parts of carbomer and 0.2 part of preservative.

The preparation method of the lactobacillus fermentation product comprises the steps of inoculating streptococcus thermophilus into a fermentation medium with an inoculation amount of 2% (v/v) of the fermentation medium, fermenting for 25 hours at 37 +/-2 ℃, continuing to ferment for 36 hours, filtering, centrifuging for 5 minutes at 4000rpm, discarding supernatant, drying and precipitating to obtain the lactobacillus fermentation product.

The preparation method of the skin cream suitable for children atopic dermatitis in the embodiment 2 to 3 comprises the following steps:

s1, grinding oat into powder, adding water with the mass 14 times that of the oat, standing for 10min at the temperature of 60 ℃ and the oscillation frequency of 160rpm, performing microwave extraction at the temperature of 85 ℃ for 8min, filtering by using a microporous filter membrane, and collecting filtrate to obtain an oat extract;

s2, mixing coconut oil, shea butter, olive fruit oil, squalane, jojoba seed oil, vaseline, white oil, glucoside, polyglycerol, hesperidin and cetostearyl alcohol, and heating to 70 ℃ to obtain a phase A;

s3, mixing provitamin B5, glycerol, hyaluronic acid, sodium alginate and carbomer, heating to 75 ℃, mixing with the phase A, and homogenizing at a stirring speed of 900r/min for 15min to obtain a phase B;

s4, cooling the phase B to 45 ℃, adding ceramide, phytosterol, lauric acid, a lactic acid bacteria fermentation product, allantoin, an oat extract, glycyrrhizic acid, glycyrrhetate and a preservative, stirring and mixing while adding, stirring for 14min, and cooling to room temperature to obtain the body lotion suitable for children atopic dermatitis.

Example 4

The skin cream suitable for children atopic dermatitis comprises the following raw materials in parts by weight: 3 parts of rapeseed oil, 2 parts of shea butter, 0.5 part of squalane, 1.2 parts of jojoba seed oil, 8 parts of vaseline, 10 parts of white oil, 1.4 parts of ceramide, 0.6 part of phytosterol, 0.4 part of lauric acid, 1.8 parts of lactobacillus fermentation product, 0.2 part of allantoin, 0.9 part of oat extract, 0.5 part of hesperidin, 0.3 part of glycyrrhizic acid, 0.5 part of glycyrrhetate, 5 parts of cetearyl alcohol, 2.5 parts of glucoside, 2.2 parts of polyglycerol, 50.8 parts of provitamin B, 6 parts of glycerol, 0.3 part of hyaluronic acid, 0.2 part of sodium alginate, 1.5 parts of carbomer and 0.2 part of preservative.

s2, mixing rapeseed oil, shea butter, squalane, jojoba seed oil, vaseline, white oil, glucoside, polyglycerol, hesperidin and cetostearyl alcohol, and heating to 70 ℃ to obtain a phase A;

Example 5

s1, grinding oat into powder, adding water with the mass 14 times of that of the oat, performing microwave extraction at 85 ℃ for 8min, filtering, and collecting filtrate to obtain an oat extract;

Comparative example 1

The skin cream suitable for children atopic dermatitis comprises the following raw materials in parts by weight: 3 parts of coconut oil, 2 parts of shea butter, 1.5 parts of olive oil, 0.5 part of squalane, 1.2 parts of jojoba seed oil, 8 parts of vaseline, 10 parts of white oil, 1.4 parts of ceramide, 0.6 part of phytosterol, 0.4 part of lauric acid, 0.2 part of allantoin, 0.9 part of oat extract, 0.5 part of hesperidin, 0.3 part of glycyrrhizic acid, 0.5 part of glycyrrhetate, 5 parts of cetostearyl alcohol, 2.5 parts of glucoside, 2.2 parts of polyglycerol, 50.8 parts of provitamin B, 6 parts of glycerol, 0.3 part of hyaluronic acid, 0.2 part of sodium alginate, 1.5 parts of carbomer and 0.2 part of preservative.

s4, cooling the phase B to 45 ℃, adding ceramide, phytosterol, lauric acid, allantoin, oat extract, glycyrrhizic acid, glycyrrhetate and preservative, stirring and mixing while adding, stirring for 14min, and cooling to room temperature to obtain the body lotion suitable for children atopic dermatitis.

Comparative example 2

The skin cream suitable for atopic dermatitis of children comprises the following raw materials in parts by weight: 3 parts of coconut oil, 2 parts of shea butter, 1.5 parts of olive oil, 0.5 part of squalane, 1.2 parts of jojoba seed oil, 8 parts of vaseline, 10 parts of white oil, 1.4 parts of ceramide, 0.6 part of phytosterol, 0.4 part of lauric acid, 1.8 parts of lactobacillus fermentation product, 0.2 part of allantoin, 0.5 part of hesperidin, 0.3 part of glycyrrhizic acid, 0.5 part of glycyrrhetate, 5 parts of cetearyl alcohol, 2.5 parts of glucoside, 2.2 parts of polyglycerol, 50.8 parts of provitamin B, 6 parts of glycerol, 0.3 part of hyaluronic acid, 0.2 part of sodium alginate, 1.5 parts of carbomer and 0.2 part of preservative.

s1, mixing coconut oil, shea butter, olive fruit oil, squalane, jojoba seed oil, vaseline, white oil, glucoside, polyglycerol, hesperidin and cetostearyl alcohol, and heating to 70 ℃ to obtain a phase A;

s2, mixing provitamin B5, glycerol, hyaluronic acid, sodium alginate and carbomer, heating to 75 ℃, mixing with the phase A, and homogenizing at a stirring speed of 900r/min for 15min to obtain a phase B;

s3, cooling the phase B to 45 ℃, adding ceramide, phytosterol, lauric acid, a lactic acid bacteria fermentation product, allantoin, glycyrrhizic acid, glycyrrhetate and a preservative, stirring and mixing while adding, stirring for 14min, and cooling to room temperature to obtain the body lotion suitable for children atopic dermatitis.

Comparative example 3

The skin cream suitable for children atopic dermatitis comprises the following raw materials in parts by weight: 3 parts of coconut oil, 2 parts of shea butter, 1.5 parts of olive oil, 0.5 part of squalane, 1.2 parts of jojoba seed oil, 8 parts of vaseline, 10 parts of white oil, 1.4 parts of ceramide, 0.6 part of phytosterol, 0.4 part of lauric acid, 1.8 parts of lactobacillus fermentation product, 0.2 part of allantoin, 0.9 part of oat extract, 0.8 part of glycyrrhetate, 5 parts of cetearyl alcohol, 2.5 parts of glucoside, 2.2 parts of polyglycerol, 50.8 parts of provitamin B, 6 parts of glycerol, 0.3 part of hyaluronic acid, 0.2 part of sodium alginate, 1.5 parts of carbomer and 0.2 part of preservative.

A method for preparing a skin cream suitable for atopic dermatitis in children comprises the following steps:

s2, mixing coconut oil, shea butter, olive fruit oil, squalane, jojoba seed oil, vaseline, white oil, glucoside, polyglycerol and cetostearyl alcohol, and heating to 70 ℃ to obtain a phase A;

Comparative example 4

The skin cream suitable for children atopic dermatitis comprises the following raw materials in parts by weight: 3 parts of coconut oil, 2 parts of shea butter, 1.5 parts of olive oil, 0.5 part of squalane, 1.2 parts of jojoba seed oil, 8 parts of vaseline, 10 parts of white oil, 1.4 parts of ceramide, 0.6 part of cholesterol, 1.8 parts of lactobacillus fermentation product, 0.2 part of allantoin, 0.9 part of oat extract, 0.5 part of hesperidin, 0.3 part of glycyrrhizic acid, 0.5 part of glycyrrhetate, 5 parts of cetearyl alcohol, 2.5 parts of glucoside, 2.2 parts of polyglycerol, 50.8 parts of provitamin B, 6 parts of glycerol, 0.3 part of hyaluronic acid, 0.2 part of sodium alginate, 1.5 parts of carbomer and 0.2 part of preservative.

s4, cooling the phase B to 45 ℃, adding ceramide, cholesterol, a lactic acid bacteria fermentation product, allantoin, an oat extract, glycyrrhizic acid, glycyrrhetate and a preservative, stirring and mixing while adding, stirring for 14min, and cooling to room temperature to obtain the body lotion suitable for children atopic dermatitis.

1. Safety test

1.1 multiple skin irritation tests.

Reference is made to the skin irritation/corrosion test in technical Specification for cosmetic safety (2015 edition);

experimental animals: 36 adult, healthy and skin-intact rabbits with the weight of 2.5 +/-0.2 kg are selected, the male and female rabbits are half in each half, and the female rabbits are infertile and have not been born. Feeding in a single cage, adapting to the environment of an experimental animal room for 3d before an experiment, wherein the environment of the experimental animal room is 20-26 ℃, the relative humidity is 40-70%, and feeding by using a standard compound feed.

The test substance: skin creams prepared in examples 1 to 5 and comparative examples 1 to 4.

The test method comprises the following steps:

firstly, the rabbits are randomly grouped 24 hours before the test, the hairs of the skin on two sides of the spine of the back of the rabbits are cut short, the left and the right parts of the hairs are respectively in the range of about 3 multiplied by 3cm, and the skin test area is A, B, C, D. And setting a left area A and a right area B as skin cream smearing areas, and setting a left area C and a right area D as blank controls.

Secondly, 0.5g of the test object is smeared on the left area A and the right area B, the smearing range is 2.5cm multiplied by 2.5cm, the number of times of smearing is 2, shearing is needed before each smearing to ensure that the test object is fully contacted with the skin, the smearing is continuously carried out for 7 days, and the stimulation reaction condition of the smeared part is observed and recorded.

After the test is finished, the smearing parts of all the groups of rabbits are found to have no symptoms such as edema, erythema, pigmentation, hemorrhage and the like, and the experimental rabbits are observed to have normal life activity and no abnormal mental state.

Test results show that the skin cream prepared by the invention has no irritation to normal skin of rabbits.

1.2 skin allergy test

The test was carried out according to the skin allergy test of technical Specification for safety of cosmetics (2015 edition);

experimental animals: 90 healthy adult guinea pigs with 250 +/-25 g weight and no skin injury are selected, and the guinea pigs are half female and half male, and female guinea pigs are infertile and have no farrowing. The method is characterized in that the method is adapted to the environment of an experimental animal room for 3d before the experiment, the environment of the experimental animal room is 20-26 ℃, the relative humidity is 40-70%, standard compound feed is selected for feeding, and a proper amount of Vc is supplemented.

The test method comprises the following steps:

dividing guinea pigs into 9 groups and 1 group of blank control group at random 24h before test, removing hair on left skin of spine of guinea pig without damaging epidermis, wherein the hair removing range is 5cm ² Guinea pig body weights were recorded before and after the experiment.

Secondly, 0.2g of the tested object is smeared on the unhairing area, two layers of gauze and one layer of cellophane are used for covering, then the unhairing area is fixed for 6 hours by using a non-irritant adhesive tape, the operation is repeated for the 7 th, the 14 th and the 28 th days, and the reaction of the smearing part is observed and recorded after 24 hours and 48 hours after the 28 th day of fixing for 6 hours. The blank control group was smeared with distilled water in the same amount, and the rest was the same as the test group.

After the test is finished, the application parts of all groups of guinea pigs are found to have no edema and no erythema symptom, and the experimental guinea pigs have normal life activity rule and no abnormal mental state. Compared with a blank control group, the weight of the guinea pigs in the test group has no obvious change before and after the test.

Test results show that the skin cream prepared by the invention has no skin allergic reaction on guinea pig skin.

2. Effect test

2.1 test of therapeutic Effect

Subject selection: selecting 50 patients, wherein the patients meet Williams diagnosis standards, score of SCORAD is more than 25, and the patients with moderate and severe atopic dermatitis in 3-18 years old who do not participate in other clinical studies are not limited, and the criteria are excluded: systemic diseases affecting the skin barrier function and other skin diseases, and children patients who are treated with glucocorticoid medicaments by using a humectant product 5 days before testing; before the research is carried out, the study is fully negotiated with the patients and the family members, and the patients and the family members voluntarily participate in the research after knowing the research content.

The test method comprises the following steps: dividing a subject into 10 groups, 9 groups as a test group, 1 group as a blank control group for measuring the moisturizing effect, after thoroughly cleaning the skin lesion, allowing the subject to sit still in a test environment for 30min, then uniformly smearing skin cream on the skin lesion, using the skin cream in the morning and the evening respectively, using triamcinolone acetonide ointment with the concentration of 0.1% every 3 days, wherein the single use amount of the triamcinolone acetonide ointment is 1 fingertip unit (FTU), one treatment course is every 28 days, 2 treatment courses are used, and other similar products are not used in the test period; the blank control group was distinguished from the test group by not using any emollient cream product.

2.1.1 measurement of moisturizing Effect

Recording the initial stratum corneum water content and the skin percutaneous water loss (TEWL) rate of the forearm skin lesion of the subject, measuring the stratum corneum water content and the skin percutaneous water loss (TEWL) rate of the forearm skin lesion at 3h, 6h and 24h after the first use of the moisturizer by the subject, respectively, continuously measuring for 3 times by using an instrument, and taking an average value, wherein the result is shown in table 1.

Table 1 moisturizing test results

According to the moisturizing test effect, after the skin cream disclosed by the invention is used, the water content of the stratum corneum of the skin can be increased, and the TEWL is low, so that the skin cream disclosed by the invention has a good moisturizing effect.

Example 3 the lactic acid bacteria fermentation product prepared by the conventional lactic acid bacteria fermentation method has high TEWL and low long-term skin water content, and example 4 does not adopt the oil component composition of the present invention, has low skin water content and high TEWL; example 5 oat extract prepared using conventional oat extract preparation method has poor long-term moisturizing effect and high TEWL.

Example 2 compared with comparative examples 1-2, it is shown that the cream does not use lactobacillus fermentation product or oat extract, fails to repair skin basal cells, has low skin water content, high TEWL, and poor moisturizing effect; the comparison of the example 2 and the comparative example 3 shows that the hesperidin, the allantoin, the glycyrrhizic acid and the glycyrrhetate can improve the moisture content of the skin; example 2 in comparison to comparative example 4 shows that the combination of phytosterols with fatty acids and ceramides reduces TEWL and stabilizes skin hydration.

2.1.2 Effect of drug

The determination method comprises the following steps: revisiting the patients after each treatment course is finished, revisiting the patients once a month within 3 months after the treatment course is finished, and recording the recurrence rate, wherein the results are shown in a table 2;

criteria for drug efficacy determination

And (3) curing: the area of the skin damage is reduced by more than 80 percent, and the skin has no pruritus and dryness;

the method has the following advantages: the area of skin damage is reduced by 40-79%, skin is slightly itchy, and the skin is not dry;

the effect is shown: the area of skin damage is reduced by 5-39%, skin is slightly itchy, and the dryness of the skin is improved;

and (4) invalidation: no obvious change of each symptom;

the total effective rate (%) (cure case + effective case + significant case)/total case x 100%;

recurrence rate (%) ═ number of symptom-aggravated cases/total cases × 100%;

TABLE 2 results of the drug efficacy test

According to experimental data, the skin cream prepared by the invention has obvious curative effect on the atopic dermatitis of children under the condition that the triamcinolone acetonide ointment is used once every 3 days, the total effective rate can reach 100% after 2 treatment courses, and the recurrence rate is low within 3 months, which shows that the skin cream can effectively assist in treating the atopic dermatitis of children, can also reduce the dosage of glucocorticoid and avoid the side effect caused by using a large amount of hormone.

Example 3 the lactic acid bacteria fermentation product prepared by using the conventional lactic acid bacteria fermentation method has no cure rate and low total effective rate after the treatment of the 1 st treatment course is finished, and the cure rate is low after the treatment of the 2 nd treatment course is finished, and example 4 does not adopt the oil component composition of the invention, so that the cure rate and the effective rate are low and the total effective rate is low; example 5 oat extract using conventional oat extract preparation method, cure rate was low; comparative examples 1-2 did not use lactobacillus fermentation product and oat extract, the cure rate was low, the total effective rate was low, and the recurrence rate after the treatment course was over was high; comparative example 3 no hesperidin is used, and the cure rate and the effective rate are both low; comparative example 4 no phytosterol was used and the cure rate was low.

2.2 bacteriostatic test

Reference is made to the Sterilization Specification (2002) for the antimicrobial (bacteriostatic) test;

test strains: staphylococcus aureus, candida albicans;

the test substance: the skin cream prepared in examples 1 to 5.

The test method comprises the following steps:

smearing a tested substance on sterile and dry filter paper, wherein the smearing area is a circle with the diameter of 5mm, the smearing thickness is 4mm, and a blank control is set;

② dipping with sterile cotton swab to obtain 5 × 10 concentration ⁵ cfu/ml test bacterial suspension was evenly spread on the surface of nutrient agar medium plate for 3 times. For each application 1 time, the plate should be rotated 60 °, and finally the cotton swab is applied around the edge of the plate for one revolution. The plate was covered and dried at room temperature for 5 min.

And thirdly, placing 3 filter paper sheets of the tested object and 1 blank control filter paper sheet on each flat plate, and taking the filter paper sheets by using sterile forceps and pasting the filter paper sheets on the surfaces of the flat plates. The distance between the centers of the filter paper sheets is more than 25mm, and the distance between the centers of the filter paper sheets and the periphery of the flat plate is more than 15 mm. After the placement, the filter paper piece was lightly pressed with sterile forceps to be tightly attached to the surface of the plate. The plate is covered, the plate is placed in an incubator at 37 ℃, and the result is observed after the plate is cultured for 16 to 18 hours. The diameter of the antibacterial ring (including the patch) was measured with a vernier caliper and recorded, with 3 replicates per group.

TABLE 3 results of the bacteriostatic test

According to bacteriostatic tests, the moisturizer disclosed by the invention has a good inhibiting effect on staphylococcus aureus and candida albicans, and has an important significance on maintaining the skin microbial environment of children suffering from AD.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims

1. The skin cream suitable for atopic dermatitis of children is characterized by comprising the following raw materials in parts by weight: 17.1-37.4 parts of grease, 0.6-3 parts of ceramide, 0.2-1 part of phytosterol, 0.2-1 part of fatty acid, 0.8-2 parts of lactobacillus fermentation product, 0.1-0.5 part of allantoin, 0.6-1.4 parts of oat extract, 0.4-0.7 part of hesperidin, 0.2-0.4 part of glycyrrhizic acid, 0.3-0.7 part of glycyrrhetate, 1-5 parts of cetearyl alcohol, 1.5-5.5 parts of emulsifier, 5.8-10.3 parts of humectant, 0.2-2 parts of thickener and 0.1-0.5 part of preservative;

the grease comprises 2-5 parts of coconut oil, 1-2 parts of shea butter, 0.5-2 parts of olive fruit oil, 0.3-0.8 part of squalane, 0.3-1.6 parts of jojoba seed oil, 5-12 parts of vaseline and 8-14 parts of white oil;

the preparation process of the skin cream comprises the following steps:

s1, grinding oats into powder, adding water with the mass being 12-15 times that of the oats, standing for 10-15 min at the temperature of 40-60 ℃ and under the condition that the oscillation frequency is 150-160 rpm, performing microwave extraction at the temperature of 80-95 ℃ for 5-10 min, filtering by using a microporous filter membrane, and collecting filtrate to obtain an oat extract;

2. The cream for children's atopic dermatitis as claimed in claim 1, wherein said fatty acid is at least one of lauric acid, arachidonic acid, myristic acid.

3. The cream of claim 1, wherein the lactobacillus fermentation product is prepared by inoculating lactobacillus rhamnosus, streptococcus thermophilus, and lactobacillus casei into a fermentation medium, fermenting at 37 ± 2 ℃ for 24-26 h, adding fucus powder 1-4 wt% of the fermentation medium, continuing to ferment for 24-36 h, filtering, adding sodium chloride into the filtrate, standing for 5-6 h, centrifuging at 2000-4000 rpm for 5-8 min, discarding the supernatant, and drying the precipitate to obtain the lactobacillus fermentation product.

4. The cream for children atopic dermatitis according to claim 1, wherein the emulsifier comprises 1 to 2.5 parts of glucoside and 0.5 to 3 parts of polyglycerol.

5. The skin cream suitable for atopic dermatitis in children as claimed in claim 1, wherein the moisturizer comprises 50.6-1.3 parts of provitamin B, 5-8 parts of glycerin, 0.1-0.5 part of hyaluronic acid, and 0.1-0.5 part of sodium alginate.

6. The cream of claim 1, wherein the thickener is at least one of xanthan gum, hydroxyethyl cellulose, carbomer, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, acrylic acid/C10-30 alkanol acrylate crosspolymer, ammonium acryloyldimethyl taurate/VP copolymer.

7. The skin cream for atopic dermatitis of children according to claim 1, wherein the homogenizing stirring speed is 900 to 1500r/min and the time is 10 to 15min in step S3.

8. The cream of claim 1, wherein the mixing in step S4 is performed by stirring and mixing the components at the same time for 10-15 min.