CN114452228B - Selenium disulfide foaming agent for hair washing and preparation method thereof - Google Patents

Abstract

The invention relates to a selenium disulfide foam agent for hair washing and a preparation method thereof, wherein the selenium disulfide foam agent comprises the following raw materials in percentage by mass: 0.05-0.5% of selenium disulfide micro powder, 5-60% of foaming agent, 0.5-7% of conditioning agent, 2-20% of foam propping agent, 1.5-10% of penetration enhancer, 0.3-4% of phosphatidylserine, 0.005-1% of antioxidant, 2-10% of propellant and the balance of water. According to the invention, through the selection and the proportion of the formula components, the obtained selenium sulfide foaming agent can effectively relieve and inhibit the symptoms of dandruff and scalp itch, has excellent sensory experience in use, and is a selenium sulfide shampoo product with market competitiveness.

Description

Selenium disulfide foaming agent for hair washing and preparation method thereof

Technical Field

The invention relates to the technical field of cosmetics, in particular to a selenium disulfide foaming agent for hair washing and a preparation method thereof.

Background

The selenium disulfide has antibacterial, antifungal, and spore-killing effects on Trichophyton mentagrophytes, and can inhibit growth of epidermal cells of head. Therefore, the shampoo is widely used for nursing scalp and hair, and has good curative effect on symptoms such as dandruff removal, seborrheic dermatitis, tinea versicolor and the like. Clinical application proves that the detergent of the selenium disulfide has better effect of removing dandruff than ketoconazole.

Aiming at selenium disulfide products, currently, selenium disulfide lotion is mostly on the market. There are some drawbacks and deficiencies. The method comprises the following specific steps: 1) based on the characteristic that selenium disulfide is almost insoluble in water or an organic solvent, the selenium disulfide lotion can be definitely a suspension, and is limited by a selenium disulfide production process in the market, the particle size of selenium disulfide powder is large, the particle size distribution is uneven, the instability of the selenium disulfide in the lotion suspension is influenced, and the lotion effect and the use experience are further influenced. The medicinal powder has poor dispersion uniformity and unstable suspension, and the medicinal powder at the local medicinal part is gathered, is not easy to clean and is easy to injure hair. 2) Because selenium disulfide is easily oxidized and blackened, there is the risk that oxidation blackens in the selenium disulfide lotion in the storage process. 3) Clinical feedback: most patients are not easy to clean after using the selenium disulfide lotion, hairs are easy to adhere and have poor combing property, and the hair quality can be damaged after long-term use. Selenium disulfide can resist fungi, has beneficial physiological effects, but still belongs to a toxic substance, has certain stimulation to eyes, skin and mucous membrane, and needs to reduce the dosage as much as possible, but the dosage of the selenium disulfide lotion which can achieve the effects in the market at present is more, which is also the main reason that the hair care agent based on selenium disulfide is difficult to receive the favor of consumers in the market.

In the prior art, there are many products such as lotions, shampoos and the like which use selenium disulfide as an active ingredient, such as CN104958211A and CN 10791212A. However, the lotion based on selenium disulfide does not overcome the defects caused by the physicochemical properties of selenium disulfide, and has the defects of different degrees of sensory use experience and safety.

CN105326672A overcomes the defects of uneven dispersion and poor suspension stability of selenium disulfide in a lotion matrix by using the selenium disulfide ultrafine powder with small particle size. But the sensory experience is still poor.

CN105473125A has solved the easy defect that discolours of selenium sulphide through the compound composition, but has not solved the dispersion of selenium sulphide inhomogeneous, unstable defect, and consumer uses the sense organ experience still not good. CN101951869A discloses a shampoo, which is prepared by adding mica into selenium disulfide suspension to form a co-suspended system, so as to improve the visual effect after shampooing.

In addition, in the cosmetic field, such as shampoo, the amount of selenium sulfide added cannot exceed 0.5%, and for the purpose of removing dandruff and relieving itching, the amount of selenium sulfide below 0.5% may be insufficient. But also limits the application of the selenium disulfide lotion.

At present, no product which can play a certain nursing and maintaining role on the hair, does not damage the hair, is easy to clean and has excellent use sense experience based on the selenium sulfide hair lotion is available in the market.

Disclosure of Invention

The invention aims to solve the technical defects of easy color change, uneven dispersion, hair adhesion, incomplete absorption, hair damage and the like of the conventional selenium sulfide lotion, and provides a selenium sulfide foaming agent and a preparation method thereof. The selenium disulfide foam agent of the invention contains 0.05 to 0.5 weight percent of selenium disulfide, preferably 0.3 to 0.4 weight percent of selenium disulfide. Can achieve the purpose of removing dandruff and relieving itching under lower selenium disulfide content.

In order to solve the technical problem, the invention provides a selenium disulfide foam agent for hair washing, which comprises the following raw materials in percentage by mass: 0.05-0.5% of selenium disulfide micro powder, 5-60% of foaming agent, 0.5-7% of conditioning agent, 2-20% of foam propping agent, 1.5-10% of penetration enhancer, 0.3-4% of phosphatidylserine, 0.005-1% of antioxidant, 2-10% of propellant and the balance of water.

The foaming agent is widely applicable to the industries of medicines and cosmetics, and is characterized by convenient use, small density, easier distribution on the epidermis than a lotion, no adhesion, guarantee of the adsorption or action time of the medicine, easy cleaning and strong compliance, and solves the problems of no adhesion, easy cleaning and strong compliance of the hair of the conventional selenium disulfide lotion. The selenium disulfide foaming agent provided by the invention has fine foam and good sensory experience for users. By selecting the formula, the selenium disulfide can achieve the effects of removing dandruff and relieving itching with a small dosage.

The penetration enhancer comprises at least one of isopropyl myristate, medical-grade azone, menthol, bis-diethoxydiol cyclohexane 1, 4-dicarboxylate, propylene glycol methyl ether acetate, polycarboxylate and polyethylene glycol.

The invention adds phosphatidylserine as an auxiliary agent of the penetration enhancer, and the addition amount is 25-40wt% of the penetration enhancer. The inventors have unexpectedly found that the addition of phosphatidylserine, which works in conjunction with a penetration enhancer, may further enhance the penetration of selenium sulphide into the skin, whereas phosphatidylserine alone does not have a penetration enhancing effect. Based on incomplete absorption of the selenium disulfide lotion, the permeation enhancer reversibly alters the barrier properties of the outer layer of the stratum corneum, thereby driving the drug through the skin membrane via intracellular pathways. The penetration enhancer and the penetration enhancer are combined together to promote or enhance the intradermal penetration or delivery of the medicament, so that the dosage of the selenium disulfide can be reduced, and the effect of removing dandruff can be effectively achieved.

More preferably, the effect is most obvious when the phosphatidylserine and the isopropyl myristate are compounded and used together. Phosphatidylserine, which helps penetration enhancers to further enhance the permeability properties of selenium disulfide, has not been found to have similar efficacy in other phospholipid compounds, such as phosphatidylcholine, phosphatidylethanolamine, phosphatidylglycerol, phosphatidylinositol, etc.

Further, the selenium disulfide foaming agent comprises the following raw materials in percentage by mass: 0.3-0.4% of selenium disulfide micro powder, 20-30% of foaming agent, 0.5-2% of conditioning agent, 6-10% of foam propping agent, 3-5% of penetration enhancer, 0.75-2% of phosphatidylserine, 0.03-0.1% of antioxidant, 5-8% of propellant and the balance of water.

Further, the selenium disulfide micro powder D90 is 4-50 μm, preferably 20-30 μm. Because of the limitation of the preparation process of the selenium disulfide micro powder at present, the particle size of the selenium disulfide on the market is generally about 100 mu m, and the particle size distribution is not uniform. The larger particle size and wider particle size distribution are not beneficial to the dispersion and stability of the selenium disulfide in the foaming agent; on the other hand, the selenium disulfide with large particle size is easy to gather, so that the dispersion is uneven, and the risk of damage to hair and scalp due to local gathering is increased.

The invention controls the D90 of the selenium disulfide micro powder to be 4-50 mu m, can solve the problem of uneven dispersion of the bulk drugs, and further prepare the foaming agent in a good suspension state. In addition, the particle size of the selenium disulfide is small, so that the adhesion between the medicine and the skin can be increased, the treatment time is prolonged, and the bioavailability of the selenium disulfide is further improved. The purpose of treatment can be achieved by using a small dose of selenium disulfide.

The selenium disulfide micro powder is prepared by the preparation method comprising the following steps: the selenium sulfide dry powder, water and glycerol are mixed according to the proportion of 1-1.2: 3-5: 1-2, then placing the mixture into an ultra-micro pulverizer to pulverize for 30-45 min, and controlling the particle size D90 within a proper range, such as 4-50 μm, preferably 20-30 μm, to form the selenium disulfide micro powder.

The foaming agent is a compound of an anionic surfactant and an amphoteric surfactant according to the mass ratio of 3-7: 1. The anionic surfactant comprises at least one of lauryl alcohol ether sulfosuccinic acid monoester disodium salt, lauroyl sarcosine sodium, fatty alcohol sulfate, fatty acid monoglyceride sulfate, succinate sulfonate and sodium dodecyl sulfate; the amphoteric surfactant comprises at least one of cocamidopropyl betaine, decyl hydroxypropyl sulfobetaine, dodecyl ethoxy sulfobetaine, hexadecyl hydroxypropyl sulfobetaine, and octadecyl ethoxy sulfobetaine. Within the above mixture ratio range, the anionic surfactant does not interact with the amphoteric surfactant to influence the stability of the system.

Even if the selenium disulfide micropowder with small particle size is insoluble substances with high density, aggregation and sedimentation exist, so that the phenomenon of uneven dispersion is generated, and the use experience of consumers is reduced. It is often necessary to add a thickener to inhibit agglomeration and settling of the selenium sulphide micropowder. However, the thickening agent is easy to cause hair adhesion, is not easy to clean, has the defects of roughness, and is not fine and smooth enough, and reduces the use experience. In a preferred technical scheme of the invention, the surfactant is a compound of lauryl alcohol ether sulfosuccinic acid monoester disodium salt and cocamidopropyl betaine according to the mass ratio of 3-7: 1. The inventor finds that the compounded surfactant can stabilize the foaming agent, so that the selenium disulfide micro powder can be stably dispersed in the matrix without adding a thickening agent, and the defects of nonuniform and unstable dispersion are overcome; and the foam is fine and smooth, and the sensory experience of a user is improved.

The conditioning agent comprises at least one of polyquaternium cationic high molecular polymer, cationic cellulose polymer and cationic guar gum.

The foam propping agent component comprises at least one of long-chain alkyl alcohol (octadecanol, hexadecanol), alcohol amine (triethanolamine, diethanolamine), paraffin, beeswax, cacao butter, fructus Citri Grandis butter, and cortex Phellodendri butter. Preferably the long-chain alkyl alcohol and the alcohol amine are compounded according to the mass ratio of 1-2: 1-2. The inventors have found that in accordance with the above formulated foam proppant, the foam is a friable and thermally stable foam when in use, i.e., it should be stable when released from a pressurized container and not crumble when exposed to the skin surface, but it should readily diffuse, decompose and be absorbed by the skin upon application of mild shear forces enabling prolonged foam time. The foam is a friable and heat stable foam, i.e., it should be stable when released from a pressurized container and not crumble when exposed to the skin surface, but it should readily diffuse, disintegrate, and be absorbed by the skin upon application of mild shear forces.

The antioxidant comprises at least one of dibutyl hydroxy toluene, vitamin C and vitamin E. Lotions containing selenium sulphide tend to discolour, the important reason being that the selenium sulphide is oxidised to black during storage. And the proper amount of antioxidant is added to effectively prevent the selenium disulfide from discoloring.

The propellant is non-freon propellant, such as at least one of tetrafluoroethane and heptafluoropropane. The advantages of the invention are also reflected in the selection of the propellant: the propellant used by some domestic and foreign manufacturers is a mixture of propane and butane, which is an extremely flammable and explosive substance, is unfavorable for production safety control, has high cost, and brings great hidden danger to daily use of people. The propellant of the invention selects the fluoro alkane or the chlorofluoro alkane, and can prepare good foaming agent. Considering that the chlorofluorocarbon propellant such as trichlorofluoromethane may cause serious damage to the earth's atmospheric ozone layer, it is not recommended to use it. Difluoroethane has properties similar to those of propane, butane and other alkanes or alkane mixture propellants, and is highly flammable and explosive. The best propellant choice is therefore to use tetrafluoroethane, heptafluoropropane or a mixture of the two.

The foaming agent also comprises a proper amount of pH regulator and alcohol solvent, wherein the pH regulator is used for regulating the pH of the final foaming agent to 4-5.5 and is selected from lactic acid; the alcohol solvent is used to dissolve the antioxidant.

Optionally, other auxiliary materials, such as 0.05-0.3% chelating agent selected from disodium diamine tetraacetate, are also added into the selenium disulfide foam agent; 0.05-1% of essence selected from at least one of lavender essence, peppermint essence, oriental cherry essence and osmanthus flower essence.

In one embodiment of the present invention, the preparation method of the selenium disulfide foaming agent comprises the following steps:

s1, placing 40-60% of water into a high-shear mixing emulsifying machine, heating to 60-70 ℃, adding a foam supporting component, a foaming agent and a chelating agent under a stirring state, and stirring to dissolve all the components to form a first mixture;

s2, dissolving the antioxidant in alcohol, slowly adding the alcohol solution of the antioxidant, the penetration enhancer, the phosphatidylserine and the conditioner into the first mixture, and stirring to dissolve all the components to obtain a second mixture;

s3, adding the selenium disulfide micro powder into the second mixture, and fully and uniformly stirring;

s4, adding a proper amount of essence and a pH regulator, supplementing water, continuing stirring and emulsifying for 1h, and cooling the tank body to room temperature to form a uniform suspension; sealing, pressing cover, and filling proper amount of propellant.

Further, in the preparation process, the water is at least one of distilled water, deionized water and sterilized water, the amount of the water used in the step S1 is 40-60% of the total amount of the water, the reaction tank is a high-shear mixing dispersing emulsifying machine reaction tank, the alcohol in the step S2 is ethanol, and the mass concentration of the alcohol solution of the antioxidant is 5-10%.

The semi-finished product prepared by the invention is in a suspension state. The propellant is pressed by an aluminum can (epoxy phenolic resin coating) after subpackaging, the ejected material is orange foam, the foam is soft and fine, has certain strength, can be quickly and uniformly coated, has no foreign body sensation, and has good sensory experience for users. In the process of developing the selenium disulfide foaming agent, a high-low temperature test is adopted to investigate the stability of the preparation. And (3) placing the finished product at 30 ℃ for 24 hours, shaking, observing the foam state, then placing at 2-8 ℃ for 24 hours at low temperature, shaking, observing the foam state, and performing a cycle. Fifteen cycles were observed continuously. The results showed that the ejection foam state was still good after fifteen cycle examinations were completed.

The samples prepared according to the method were subjected to stability in use. The foam state is observed every day according to the single usage amount, the total amount of the foam is finally sprayed to be more than 90 percent until the foam is completely sprayed, and the foam state is good when the foam is sprayed every time.

Samples prepared according to this method were subjected to accelerated 6 month and long term 12 month stability studies. The results show that the formulation samples have very good stability and the product maintains a good foam state.

Drawings

FIG. 1 is a comparison of the amount of skin membrane penetration within 24 hours of the lathering agent of formula 5-1 of the present invention and a conventional lotion;

FIG. 2 is a graph showing the stability test of the foaming agent of the formulation 5-1 of the present invention, wherein FIG. 2(A) is a state in which the foaming agent is discharged when stored for 0 day, and FIG. 2(B) is a state in which the foaming agent is discharged after stored for 6 months under accelerated conditions.

Detailed Description

The preparation and properties of the selenium sulphide foam formulation according to the invention are further illustrated by the following specific examples.

The selenium sulfide dry powder is purchased from Hubei Huishaopu pharmaceutical technology Co., Ltd, D90 about 150 μm.

The foaming quality of the foam was evaluated on 4 scales as follows: 1) and (3) excellent: the appearance is rich, the foam support is good, the foam structure is not contained, and the foam keeps very obvious creaminess when being diffused on the skin; 2) good: the appearance is rich, a small amount of micro-bubble structures are provided, and the film has certain creaminess when being spread on the skin; 3) in general: the visible foam cream is less, has a visible bubble structure, and becomes thin and wet when spread on the skin; 4) difference: no cream was seen, the foam was dry, large and weak bubbles, difficult to spread on the skin.

Preparation example 1

Mixing dry powder of selenium disulfide with D90 of about 130 μm, water and glycerol according to a mass ratio of 1: 3: 1, uniformly mixing, and crushing in an ultrafine crusher for 30min to finally obtain the selenium disulfide micro powder with the D90 of about 22 mu m.

Preparation example 2

Weighing the components according to the proportion, and preparing the selenium disulfide foaming agent according to the following steps:

s1, placing deionized water accounting for 50% of the total amount in a high-shear mixing emulsifying machine reaction tank, heating to 60 ℃, adding a foam supporting component, a foaming agent and a chelating agent under a stirring state, and stirring to dissolve all the components to form a first mixture;

s2, dissolving an antioxidant in alcohol, slowly adding 10wt% of an alcohol solution of the antioxidant, a penetration enhancer, phosphatidylserine and a conditioner into the first mixture, and stirring to dissolve all the components to obtain a second mixture;

s3, adding the selenium disulfide micro powder into the second mixture, and fully and uniformly stirring;

s4, adding a proper amount of essence and lactic acid serving as a pH regulator, supplementing deionized water, continuing stirring and emulsifying for 1h, and cooling the tank body to room temperature to form uniform suspension; sealing, capping and filling proper amount of propellant.

Examples in the following examples, the amounts of the respective raw materials were in mass%.

Example 1 study of antioxidants:

the selenium disulfide foaming agent is prepared according to the method of preparation example 2, and the formula of the foaming agent in percentage by mass is shown in the following table 1:

TABLE 1 foaming agent composition

Different antioxidants are compared, and the antioxidant effect of the dibutyl hydroxy toluene (BHT) is found to be superior to that of the vitamin E, and the foam color can be prevented from changing color at a lower dosage. Through tests, different using amounts of the antioxidant are compared, so that the sample can not change color when the content of the Butylated Hydroxytoluene (BHT) is within the range of 0.005-10%, and the antioxidant effect cannot be achieved when the content of the butylated hydroxytoluene is less than 0.01%; more than 10% (0.1% w/w) may cause chronic poisoning, teratogenicity, metabolic disturbance and other risks to human body, so the optimal dosage is 0.03-0.1%.

EXAMPLE 2 investigation of Conditioning Agents

The selenium disulfide foaming agent is prepared according to the method of preparation example 2, and the formula of the foaming agent in percentage by mass is shown in the following table 2:

TABLE 2 foaming agent composition

As can be seen from the comparison of different types and dosages of the conditioning agent in the table 2, when the dosage of the conditioning agent is less than or equal to 0.2%, the phenomena of adhesion and poor combing property of hair occur; when the range of the conditioner is 0.3-7%, the condition of hair adhesion can be solved, and the combing performance is good. The dosage of the conditioner is not excessive, and the conditioner is safer within the preferable range of 0.5-2%. Furthermore, it should be noted that when polyquaternium is used as the conditioning agent, the amount of the polyquaternium is not more than 3% because the cationic density of the polyquaternium is high, and the effect of the anionic surfactant in the foaming agent can be affected when the amount of the polyquaternium is large. Furthermore, as can be seen from table 2, the foaming condition is optimal when the foamed proppant is a combination of cetyl alcohol and triethanolamine.

EXAMPLE 3 investigation of blowing agent

The selenium disulfide foaming agent is prepared according to the method of preparation example 2, and the formula of the foaming agent in percentage by mass is shown in the following table 3:

TABLE 3 foaming agent composition

As can be seen from Table 3, in order to ensure the foaming and cleaning effects, the amount of the foaming agent is preferably in the range of 20 to 30% to achieve good foaming effects. Preferably, the anionic surfactant and the amphoteric surfactant are compounded according to a certain mass, particularly the compounding of the lauryl alcohol ether sulfosuccinic acid monoester disodium salt and the cocamidopropyl betaine in a ratio of 3-7:1, so that the optimal foaming effect can be achieved.

EXAMPLE 4 propellant Studies

The selenium disulfide foaming agent is prepared according to the method of preparation example 2, and the formula of the foaming agent in percentage by mass is shown in the following table 4:

TABLE 4 foaming agent composition

The use amount of the propellant determines the formability of the foam, the addition amount of the propellant is too small or too large, the forming of the foam is not facilitated, 2-8% of the propellant can form good foam, preferably 5-8%, and the tetrafluoroethane and the heptafluoropropane are both suitable for use.

Example 5 investigation of the composition of foamed proppant

The selenium disulfide foaming agent is prepared according to the method of preparation example 2, and the formula of the foaming agent in percentage by mass is shown in the following table 5:

TABLE 5 foaming agent composition

The foam supporting components and the using amount are researched, and the foaming quality is optimal when the long-chain alkyl alcohol (cetyl alcohol and/or stearyl alcohol) and the alcohol amine (triethanolamine and/or diethanolamine) are compounded to be used as the foam supporting agent. The foam support component has low dosage, poor foam support property, general quality and short foam collapse time, is not beneficial to fully infiltrating and contacting the scalp, and reduces the treatment effect; excessive use amount can cause excessive foam support and partial hardness, and the foam collapse time is too long. After verification, the existence time of the foam is preferably 3-5 min.

Example 6 Effect of selenium disulfide particle size

The foam formulation was the same as formulation 5-1 of example 5 except that the selenium sulphide particle size was different. The results are shown in table 6 below:

TABLE 6 comparison of Properties of selenium disulfide foams of different particle sizes

The particle size of the selenium disulfide dry powder is reduced after crystal form treatment, so that the uniform dispersion of the bulk drugs is facilitated, and the particle size D90 of the bulk drug selenium disulfide is controlled to be 10-50 μm.

Example 7 enhancement of intradermal penetration or delivery of drugs

The selenium disulfide foam agent is prepared according to the method of preparation example 2, and the formula of the foam agent components in percentage by mass is shown in the following table 7. This example studies the effect of carrier on transdermal absorption by selenium disulfide foam via a 1.05mm thick synthetic silicone rubber membrane to simulate the mechanism of skin permeation by the foam of the present invention.

The specific operation is to establish a Franz diffusion cell, fix a 1.05mm thick silicon rubber membrane, apply 0.1g of 1.3% selenium disulfide foam agent prepared by the prescriptions 7-1 to 7-7 of the example 7 on the 1.05mm thick silicon rubber membrane with the coating area of 1cm after the receiving cell is a physiological saline receiving liquid with the same pH and the same osmotic pressure as human plasma and the temperature of the water bath of the receiving cell is controlled to be 32 ℃ and the temperature of the receiving liquid of the receiving cell is controlled to reach 32 DEG C²And after 24 hours of administration, the receiving solution is filtered by a microporous filter membrane, and the content of the selenium disulfide is detected by HPLC, and the transdermal rate is calculated.

TABLE 7 foaming agent composition

As can be seen from the data in Table 7, the penetration enhancer and the phosphatidylserine are used as the penetration enhancer aid, so that the transdermal rate of the selenium disulfide can be obviously improved, and the curative effect can be ensured while the content of the selenium disulfide is reduced. The inventor surprisingly found that the combination of phosphatidylserine and isopropyl myristate was most significant in enhancing penetration. Other conventional penetration enhancers are matched with phosphatidylserine, so that the penetration enhancing effect is not obviously improved. Phosphatidylserine alone does not promote penetration.

The present invention also compares the permeation and distribution of the selenium sulfide foam of the present invention (formula 5-1, selenium sulfide content 0.42wt%) with commercially available selenium sulfide lotions (diluted to 0.5wt% selenium sulfide content). The permeation simulation test is the result of measurements through porcine skin (thickness-0.25 mm) using a flow-through diffusion cell. Receptor fluid was collected every 4 hours for 24 hours and the amount of selenium sulphide was determined. After 24 hours of administration, after the last receptor solution sample was collected, the skin surface was continuously washed, wiped and taped 2 times. The epidermis is then carefully peeled away from the dermis. Acetonitrile was used to extract the drug from the surface washing material, epidermis and dermis. And quantifying the content of the selenium disulfide by adopting a High Performance Liquid Chromatography (HPLC) mass spectrum method. The results are shown in fig. 1, which shows that the amount of selenium disulfide accumulated in the receptor fluid after penetrating the skin membrane is greater within 24 hours after using selenium disulfide in the foam carrier of the present invention as compared to conventional selenium disulfide lotion. The selenium disulfide foam has more active drug delivered to the skin than the selenium disulfide lotion. Indicating that the selenium disulfide foam of the present invention has the ability to deliver more active drug at a faster rate than a lotion. This is true whether it is into a synthetic lipophilic barrier (silicone rubber membrane) or into a thin skin sample (living human donor) living human donor. These findings also indicate that the foams of the present invention utilize a non-traditional "rapid penetration" route for drug delivery. The components within the foam act as permeation enhancers, reversibly altering the barrier properties of the outer layers of the stratum corneum, thereby pushing the drug through the skin membrane via intracellular pathways.

EXAMPLE 8 study of stability

The selenium sulfide foaming agent of formula 5-1 was tested and the results are shown in Table 8 below:

TABLE 8 selenium disulfide foam index

Accelerated tests (40 ℃, 75% RH) and long-term tests (25 ℃, 60% RH) were carried out to test the stability, with the results shown in table 9 below:

table 9 stability test data

The stability test results in table 9 show that the selenium disulfide foam prepared by the invention has good stability after being accelerated for 6 months and prolonged for 12 months, and does not influence the foaming condition of the foam. The selenium disulfide does not have agglomeration or sedimentation phenomenon.

FIG. 2 is a graph showing the stability test of the foaming agent of the invention of formula 5-1, FIG. 2(A) is a state where the foaming agent is discharged when stored for 0 day, and FIG. 2(B) is a state where the foaming agent is discharged after stored for 6 months under accelerated conditions. It can be seen that the foaming agent of the invention has good stability, and the sprayed foam state meets the requirements after being stored for 6 months under accelerated conditions.

Application example

Please refer to 120 patients with intractable dandruff and scalp pruritus, which are randomly divided into two groups, wherein each group comprises 60 subjects, the gender and the hair quality condition of the two groups of subjects have no statistical significant difference, the subjects in the experimental group 1 are cleaned by using the selenium disulfide foam agent (the content of the selenium disulfide is 0.42wt%) with the prescription 5-1 of the invention every 3 days, the retention time of the foam on the scalp is controlled to be 30s, and the retention time lasts for 1 month; test subjects in experimental group 2 used commercially available selenium disulfide lotion (selenium disulfide content 1.5wt%) every 3 days for one month. Poor response to the interview questionnaire of the subjects, and sensory experience (scoring from three angles of smoothness, adhesiveness and easiness in cleaning, each angle is fully divided into 10 points, 10 points indicate the most satisfactory, 0 point indicates the most unsatisfactory, and the average point is calculated after the total point is obtained), whether symptoms of dandruff and scalp itching can be relieved or not. The results are shown in Table 10 below.

TABLE 10 use Effect of selenium disulfide foams and lotions

Medicine and food additive	Sensory experience	Dandruff suppression	Suppression of scalp itching
				The formula 5-1 foaming agent of the invention	23.7	53/60	53/60
Commercial selenium disulfide lotion	19.6	55/60	56/60

Therefore, the selenium disulfide foam agent and the traditional commercially available selenium disulfide lotion have basically the same curative effect in removing dandruff and inhibiting scalp itch, but the consumption experience of users is obviously improved. On the other hand, the invention effectively removes dandruff and inhibits pruritus, which is achieved under the condition of much lower selenium disulfide concentration of the commercially available selenium disulfide lotion, thereby improving the safety and reducing the side effect of selenium disulfide on users.

Claims (7)

1. The selenium disulfide foaming agent for washing hair is characterized by comprising the following raw materials in percentage by mass: 0.05-0.5% of selenium disulfide micro powder, 5-60% of foaming agent, 0.5-7% of conditioning agent, 2-20% of foam propping agent, 1.5-10% of penetration enhancer, 0.3-4% of phosphatidylserine, 0.005-1% of antioxidant, 2-10% of propellant and the balance of water;

wherein, the selenium disulfide micro powder D90 is 4-50 μm;

the penetration enhancer is selected from at least one of isopropyl myristate, medical grade azone or menthol;

the foam propping agent is a compound of long-chain alkyl alcohol and alcohol amine according to the mass ratio of 1-2:1-2, wherein the long-chain alkyl alcohol is at least one of stearyl alcohol and cetyl alcohol, and the alcohol amine is at least one of triethanolamine and diethanolamine.

2. The selenium sulfide foaming agent of claim 1, comprising the following raw materials in percentage by mass: 0.1-0.4% of selenium disulfide micro powder, 20-30% of foaming agent, 0.5-2% of conditioning agent, 6-10% of foam propping agent, 3-5% of penetration enhancer, 0.75-2% of phosphatidylserine, 0.03-0.1% of antioxidant, 5-8% of propellant and the balance of water.

3. The selenium disulfide foam agent as claimed in claim 1, wherein the foaming agent is a compound of an anionic surfactant and an amphoteric surfactant in a mass ratio of 3-7: 1; the anionic surfactant comprises at least one of lauryl alcohol ether sulfosuccinic acid monoester disodium salt, sodium lauroyl sarcosinate, fatty alcohol sulfate, fatty acid monoglyceride sulfate and succinate sulfonate; the amphoteric surfactant comprises at least one of cocamidopropyl betaine, decyl hydroxypropyl sulfobetaine, dodecyl ethoxy sulfobetaine, hexadecyl hydroxypropyl sulfobetaine, and octadecyl ethoxy sulfobetaine.

4. The selenium sulfide foaming agent according to claim 1, wherein the foaming agent is a compound of laureth sulfosuccinate disodium salt and cocamidopropyl betaine according to a mass ratio of 3-7: 1.

5. The selenium sulfide foam of claim 1, wherein the conditioning agent is selected from at least one of a polyquaternium cationic high molecular polymer, a cationic cellulose polymer, and a cationic guar gum.

6. A selenium sulphide foam according to claim 1 wherein the antioxidant is selected from at least one of dibutylhydroxytoluene, vitamin C and vitamin E; the propellant is a non-freon propellant.

7. A process for the preparation of a selenium sulphide foam formulation as claimed in any one of claims 1 to 6, comprising the steps of:

s1, placing water in a reaction tank, heating to 60-80 ℃, adding a foam propping agent under a stirring state, optionally adding auxiliary materials, and stirring to dissolve all the components to form a first mixture;

s2, dissolving the antioxidant in alcohol, slowly adding the alcohol solution of the antioxidant, the penetration enhancer, the phosphatidylserine and the conditioner into the first mixture, and stirring to dissolve all the components to obtain a second mixture;

s3, adding the selenium disulfide micro powder into the second mixture, and fully and uniformly stirring;

s4, adding a proper amount of essence and a pH regulator, supplementing water, continuously stirring and emulsifying for 1h, and simultaneously cooling the tank body to room temperature to form a uniform suspension; sealing, capping and filling proper amount of propellant.

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