Anti-dandruff and anti-itching compositions and use thereof

Abstract

The present application belongs to the field of natural products, and discloses a composition capable of removing dandruff and improving itching and application thereof. The raw material of the active ingredient of the composition comprises Sophora flavescens, Stemona, clove and cortex moutan. The composition of some examples of the present application is produced by the joint action of insecticidal and antipruritic traditional Chinese medicine and blood-cooling and anti-inflammatory cortex moutan, and the effect thereof is better than that of the insecticidal and antipruritic traditional Chinese medicine or the blood-cooling and anti-inflammatory cortex moutan, and the two have a synergistic effect on improving the scalp health. The active ingredient is a natural product, which is mild, safe, improves the scalp environment from the source, inhibits the breeding of harmful bacteria on the scalp, prevents the generation of dandruff and improves the itching of the scalp, and is not prone to drug resistance.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of natural products, and particularly relates to a composition capable of removing dandruff and improving itching and application thereof. BACKGROUND

[0002] Human head epidermal cells are constantly proliferating and dividing, and dead epidermal cells form a keratin layer and are automatically shed; in normal human metabolism, a small amount of dandruff produced on the head is a normal phenomenon. However, with irregular work and rest, high mental stress, frequent insomnia, and abuse of various head washing and care chemicals, the scalp microenvironment is imbalanced, accompanied by secretion of a large amount of oil; when the oil secretion is excessive, it is easy to cause pore blockage and breed a large amount of bacteria, thereby causing itching, redness, and a large amount of dandruff phenomenon, which seriously disturbs people's daily life.

[0003] There are many dandruff-removing and itching-relieving washing and care products on the market, and most of them use chemical dandruff-removing agents or mainly use chemical dandruff-removing agents supplemented with traditional Chinese medicine. The early chemical dandruff-removing agents include sulfur, salicylic acid, selenium disulfide, etc. Sulfur and salicylic acid have a bactericidal effect and are highly irritating, which can easily cause damage to the skin; dandruff-removing cosmetics mainly containing selenium disulfide also have strong irritation, and after use, the hair feels rough and harsh, and if not washed thoroughly, the hair may be discolored, a small number of users may accelerate hair loss, and there is an odor. In recent decades, the main dandruff-removing agents used include zinc pyrithione (also known as zinc pyrithione, ZPT), climbazole (CLM), and piroctone olamine (OCT), etc. Compared with early products, these dandruff-removing agents have slightly better safety and stronger dandruff-removing effect, and are widely used in dandruff-removing products. However, long-term use and residues of these chemical dandruff-removing agents can destroy the scalp metabolism balance, cause inflammation and bacterial imbalance, and further increase the amount of dandruff and itching. For example, the European Union banned the use of zinc pyrithione (ZPT) in cosmetics on March 1, 2022. With the trend of green, environmental protection, natural, and low carbon, it has become a new development direction to extract natural green dandruff-removing agents from plants or to use traditional Chinese medicine to remove dandruff. Therefore, it is of great significance to develop natural, mild, and safe dandruff-removing products, improve the scalp environment, inhibit the breeding of harmful bacteria on the scalp, and prevent the generation of dandruff and improve scalp itching from the source.

[0004] CN114515260A discloses a fatty acid monoester compound plant dandruff and itching relieving agent, which contains star anise fruit extract, and the addition amount is 10%. The fatty acid monoester can effectively inhibit malassezia, regulate sebum secretion, and restore the skin barrier. However, the low formula amount (10%) is added to the product and then diluted again, which can also solve the problem of scalp harmful flora and improve the problem of scalp itching. It needs to be verified after the product is put on the market. CN110025516A discloses a moisturizing and dandruff-removing senile weak acid medicated bath cream, which uses Chinese herbal medicines such as ginseng, yinyangiao, ophiopogon, sargent rue, baixianpi, kuh-seng, and kochia scoparia. The object of use is the rehabilitation and health care of dry skin, dandruff and itching of the elderly, and there is no mention of scalp care. CN110787112A discloses a dandruff-removing composition, which is prepared by mixing jinyeguo extract, cypress leaf extract, hupu bark extract and kuh-seng root extract in a specific ratio, so that the dandruff-removing composition has good oil control and sterilization effect. However, this technology uses purchased extracts for compounding, and does not study the effect of co-extracted composite extract on dandruff and itching relief. CN109864930B discloses a plant extract composition with scalp care effect, which is prepared from the following components in mass percentage: 1-98% of vitex negundo fruit, 1-98% of gentiana and 1-98% of radix falatiae. The composition has the effects of protecting the scalp, repairing damage, fundamentally repairing the scalp barrier and maintaining the stability of the scalp. However, this invention is not mainly aimed at dandruff problem.

[0005] From the perspective of traditional Chinese medicine, the scalp still belongs to the part of the skin and is dominated by the lung. If the lung qi is deficient, the yin is deficient and the blood is dry, the lung cannot well transport and transform qi and blood, and regulate the water passage of the triple energizer. Part of the garbage in the blood is discharged from the skin, causing the skin to secrete oil, and the dandruff is caused by the dry blood. External use of traditional Chinese medicine can cool blood, detoxify, kill insects and relieve itching, and can solve the problems of dandruff and itching.

[0006] The market lacks a natural, mild, safe product with good dandruff and itching relief effect, which can improve the scalp environment from the source, inhibit the growth of harmful bacteria on the scalp, prevent the generation of dandruff and improve the itching of the scalp. It is necessary to develop such products to meet the needs of people for scalp health. SUMMARY

[0007] The purpose of the present application is to overcome at least one of the deficiencies of the prior art and provide a composition for removing dandruff and improving itching and its application.

[0008] The technical solution adopted by the present application is:

[0009] In a first aspect of the present application, there is provided:

[0010] A composition, the raw materials of the active ingredients of which include kuh-seng, stemona, clove and cortex moutan.

[0011] In some examples of the composition, the raw materials are in a mass ratio of 2-40 parts of Sophora flavescens, 2-20 parts of Stemona, 2-20 parts of Clove, and 2-40 parts of Tree Peony Bark.

[0012] In some examples of the composition, the raw materials are in a mass ratio of 10-30 parts of Sophora flavescens, 5-15 parts of Stemona, 5-15 parts of Clove, and 10-30 parts of Tree Peony Bark.

[0013] In some examples of the composition, the active ingredient is a solvent extract, a supercritical extract, or a powder of the raw material. The powder can be a fine powder, a super-micro powder, or a broken-wall powder obtained by crushing the medicinal material. The supercritical extract can be a supercritical carbon dioxide extract.

[0014] In some examples of the composition, the solvent is at least one selected from water, alcohol, and a non-polar solvent. An acid or a base can be further added to the solvent as needed to obtain a better extraction effect. For example, an appropriate amount of acid can be added when the active ingredient contains alkaloids, or an appropriate amount of base can be added when the active ingredient contains acid.

[0015] In some examples of the composition, the alcohol is selected from ethanol, propylene glycol, 1,3-propylene glycol, and butylene glycol.

[0016] In some examples of the composition, the composition further comprises an acceptable adjuvant.

[0017] In some examples of the composition, the composition is a lotion, an essence, a hair conditioner, a cream, or an ointment.

[0018] In a second aspect of the present application, there is provided a use of the composition of the first aspect in the preparation of an itch reliever.

[0019] In a second aspect of the present application, there is provided a use of the composition of the first aspect in the preparation of an itch reliever.

[0020] In some examples of the use, the itch is selected from scalp itch, tinea pedis itch caused by fungal infection, and body tinea itch.

[0021] In a third aspect of the present application, there is provided a use of the composition of the first aspect in the preparation of an anti-dandruff product.

[0022] In a third aspect of the present application, there is provided a use of the composition of the first aspect in the preparation of an anti-dandruff product.

[0023] The present application has the following beneficial effects:

[0024] The composition of some examples of the present application, the insecticidal and antipruritic traditional Chinese medicine and the blood-cooling and anti-inflammatory cortex moutan jointly produce effects, and the effects are better than those of the insecticidal and antipruritic traditional Chinese medicine or the blood-cooling and anti-inflammatory cortex moutan alone. The active ingredients are natural products, which are mild and safe, can improve the scalp environment from the source, inhibit the growth of harmful bacteria on the scalp, prevent the generation of dandruff and improve the itching of the scalp, and are not prone to drug resistance.

[0025] The composition of some examples of the present application has a simple preparation process and is convenient for industrialized production. DETAILED DESCRIPTION

[0026] The first aspect of the present application provides:

[0027] A composition, the raw materials of the active ingredients of which include sophora flavescens, stemona, clove and cortex moutan.

[0028] The medicinal material sophora flavescens in the composition of the present application is distributed to the heart, liver, stomach, large intestine and bladder meridians. It has the effects of clearing heat and drying dampness, killing insects and diuresis. It is mainly used for treating dysentery, hematochezia, jaundice, urinary retention, leukorrhagia, hypogastric mass and pruritus, eczema, dermatitis, pruritus and scabies. It is also used for treating trichomonas vaginitis.

[0029] The medicinal material stemona in the composition of the present application is sweet and bitter in taste, slightly warm in nature and is distributed to the lung meridian. It has the effects of moistening the lung, relieving cough, killing insects and destroying lice. It is mainly used for treating new and old cough, phthisis and cough, and is also used for treating head lice, body lice, enterobiasis and pruritus.

[0030] The medicinal material clove in the composition of the present application is pungent in taste, warm in nature and is distributed to the spleen, stomach, lung and kidney meridians. It has the effects of warming the middle and descending adverse qi, and tonifying the kidney and assisting yang. It is used for treating spleen and stomach deficiency, hiccup, vomiting and diarrhea, cold pain in the heart and abdomen, and impotence due to kidney deficiency. According to the records in the Herbal Medicine, clove is used for treating anorexia, bone and joint pain, treating qi, blackening the beard, killing insects, treating five hemorrhoids, expelling evil and treating milk flower, stopping five-color toxic dysentery, and relieving abdominal pain.

[0031] The medicinal material cortex moutan in the composition of the present application is bitter and pungent in taste, slightly cold in nature and is distributed to the heart, liver and kidney meridians. It has the effects of clearing heat and cooling blood, and promoting blood circulation to remove blood stasis. It is used for treating warm toxin with rashes, hematochezia, night fever and early cooling, bone dryness, amenorrhea, dysmenorrhea, abscesses and sores, and traumatic injury.

[0032] Among them, sophora flavescens, stemona and clove have the effects of killing insects, drying dampness and relieving itching, and cortex moutan and sophora flavescens have the effects of clearing heat, cooling blood, detoxification and relieving itching. The combination has the effects of clearing heat and drying dampness, killing insects and relieving itching, and cooling blood and detoxification, and can effectively inhibit scalp fungal infection and reduce inflammatory reaction, so as to solve the problems of dandruff and itching from the root.

[0033] In some examples of the composition, the mass ratio of the raw materials is as follows: sophora flavescens 2-40 parts, stemona 2-20 parts, clove 2-20 parts, and cortex moutan 2-40 parts.

[0034] In some examples of the composition, the mass ratio of the raw materials is 10-30 parts of Sophora flavescens, 5-15 parts of Stemona, 5-15 parts of Clove, and 10-30 parts of Cortex Moutan.

[0035] In some examples of the composition, the active ingredient is a solvent extract, a supercritical extract, or a powder of the raw material. The powder can be a fine powder, a super-micro powder, or a broken wall powder obtained by crushing the medicinal material. The supercritical extract can be a supercritical carbon dioxide extract.

[0036] In some examples of the composition, the solvent is at least one selected from water, alcohol, and non-polar solvent. An acid or a base can be further added to the solvent as needed to obtain a better extraction effect. For example, an appropriate amount of acid can be added when the active ingredient contains alkaloids, or an appropriate amount of base can be added when the active ingredient contains acid.

[0037] In some examples of the composition, the alcohol is selected from ethanol, propylene glycol, 1,3 propylene glycol, and butylene glycol. These alcohols can be added as needed to obtain a better extraction effect.

[0038] In some examples of the composition, an acceptable adjuvant is further included. The adjuvant can be selected according to the dosage form of the composition.

[0039] In some examples of the composition, the composition is an external agent such as lotion, essence, hair conditioner, cream, ointment, etc.

[0040] In a second aspect of the present application, there is provided:

[0041] In a third aspect of the present application, there is provided:

[0042] In some examples of the application, the itch is selected from scalp itch, tinea pedis itch caused by fungal infection, and tinea corporis itch.

[0043] In a second aspect of the present application, there is provided:

[0044] In a third aspect of the present application, there is provided:

[0045] The content of the present application is further described in detail below in combination with specific examples. It should be understood that these examples are only used to illustrate the present application and not to limit the scope of the present application.

[0046] Example 1

[0047] A traditional Chinese medicine composition capable of inhibiting Malassezia and improving the symptoms of scalp itch, wherein the effective ingredient is prepared from the following raw materials: 10 parts of Sophora flavescens, 15 parts of Stemona, 5 parts of Clove, and 30 parts of Cortex Moutan.

[0048] The Chinese medicine composition is prepared into a finished product, including the following steps:

[0049] (1) The Sophora flavescens, Stachys geoffroyi, Syzygium aromaticum and Paeonia suffruticosa are weighed according to the prescription amount, mixed, and a mixture is obtained;

[0050] (2) The mixture obtained in step (1) is placed in an extraction tank, 8 times the amount of water is added, soaked for 2 hours, boiled, heated to reflux for 1.5 hours, filtered, and the filtrate is used for the next step. The filter residue is added with 7 times the amount of water, heated to reflux for 1.5 hours, filtered, and the two filtrates are combined. The combined filtrate is concentrated under reduced pressure to obtain a concentrated solution with a ratio of 1:10 (herbal medicine: extraction liquid, mass ratio). Or the concentrated solution is further concentrated to obtain a thick paste;

[0051] (3) The thick paste obtained in step (2) is placed in a vacuum drying box and dried under the following conditions: temperature 75°C, vacuum degree less than -0.085 Mpa. After drying, the product is taken out and pulverized to obtain a dry paste powder;

[0052] (4) Or, the dry paste powder obtained in step (3) is further granulated with appropriate excipients to obtain granules.

[0053] Example 2

[0054] A Chinese medicine composition capable of inhibiting Malassezia and improving the symptoms of scalp pruritus, the effective components of which are prepared from the following raw materials: Sophora flavescens 30 parts, Stachys geoffroyi 5 parts, Syzygium aromaticum 15 parts, and Paeonia suffruticosa 10 parts.

[0055] The Chinese medicine composition is prepared into a finished product, including the following steps:

[0056] (1) The Sophora flavescens, Stachys geoffroyi, Syzygium aromaticum and Paeonia suffruticosa are weighed according to the prescription amount, mixed, and a mixture is obtained;

[0057] (2) The mixture obtained in step (1) is placed in an extraction tank, 8 times the amount of water is added, soaked for 2 hours, boiled, heated to reflux for 1.5 hours, filtered, and the filtrate is used for the next step. The filter residue is added with 7 times the amount of water, heated to reflux for 1.5 hours, filtered, and the two filtrates are combined. The combined filtrate is concentrated under reduced pressure to obtain a concentrated solution with a ratio of 1:10 (herbal medicine: extraction liquid, mass ratio). Or the concentrated solution is further concentrated to obtain a thick paste;

[0058] (3) The thick paste obtained in step (2) is placed in a vacuum drying box and dried under the following conditions: temperature 75°C, vacuum degree less than -0.085 Mpa. After drying, the product is taken out and pulverized to obtain a dry paste powder;

[0059] (4) The dry paste powder obtained in step (3) is further granulated with appropriate excipients to obtain granules.

[0060] Example 3

[0061] A traditional Chinese medicine composition capable of inhibiting Malassezia and improving symptoms of scalp pruritus, the effective ingredient of which is prepared from the following raw materials: Sophora flavescens 15 parts, Farfarae 12 parts, clove 8 parts, and Paeonia suffruticosa 25 parts.

[0062] The above-mentioned traditional Chinese medicine composition is prepared into a finished product, including the following steps:

[0063] (1) According to the formula, weigh Sophora flavescens, Farfarae, clove, and Paeonia suffruticosa, mix, and obtain a mixture;

[0064] (2) Put the mixed medicinal materials of step (1) into an extraction tank, add 8 times the amount of 50% ethanol, soak for 2 hours, heat and reflux extract for 1.5 hours, filter, and reserve the filtrate; add 7 times the amount of 50% ethanol to the residue, heat and reflux extract for 1.5 hours, filter, combine the two filtrates, and reduce pressure to concentrate, to obtain a concentrated solution of 1:10 (mass ratio of medicinal materials to extract); or further concentrate to obtain a thick paste;

[0065] (3) Put the thick paste of step (2) into a vacuum drying box, dry under the conditions of a temperature of 75°C and a vacuum degree of -0.085 Mpa, take out after drying, and pulverize to obtain a dry paste powder;

[0066] (4) Add an appropriate amount of excipient to the dry paste powder of step (3), granulate, and obtain granules.

[0067] Example 4

[0068] A traditional Chinese medicine composition capable of inhibiting Malassezia and improving symptoms of scalp pruritus, the effective ingredient of which is prepared from the following raw materials: Sophora flavescens 20 parts, Farfarae 8 parts, clove 12 parts, and Paeonia suffruticosa 20 parts.

[0069] The above-mentioned traditional Chinese medicine composition is prepared into a finished product, including the following steps:

[0070] (1) According to the formula, weigh Sophora flavescens, Farfarae, clove, and Paeonia suffruticosa, mix, and obtain a mixture;

[0071] (2) Put the mixed medicinal materials of step (1) into an extraction tank, add 8 times the amount of 50% ethanol, soak for 2 hours, heat and reflux extract for 1.5 hours, filter, and reserve the filtrate; add 7 times the amount of 50% ethanol to the residue, heat and reflux extract for 1.5 hours, filter, combine the two filtrates, and reduce pressure to concentrate, to obtain a concentrated solution of 1:10 (mass ratio of medicinal materials to extract); or further concentrate to obtain a thick paste;

[0072] (3) Add 4 parts of malt dextrin into the thick paste of step (2) slowly, stir well, and spray dry to obtain spray dried powder. Spray drying conditions: inlet temperature 175-180°C, outlet temperature 75-80°C, atomization pressure 0.24 MPa, thick paste temperature 70-75°C, and the relative density of the thick paste of step (2) is 1.10-1.12 (5 parts of malt dextrin has been added, 50°C).

[0073] (4) Add the dry paste powder of step (3) into appropriate amount of excipients, granulate to obtain granules.

[0074] Example 5

[0075] A traditional Chinese medicine composition capable of inhibiting Malassezia and improving the symptoms of scalp pruritus, the effective ingredient of which is prepared from the following raw materials: Sophora flavescens 25 parts, Farfarae 10 parts, Clove 15 parts, and Tree Peony Bark 10 parts.

[0076] The above traditional Chinese medicine composition is prepared into finished products, including the following steps:

[0077] (1) Weigh Sophora flavescens, Farfarae, Clove, and Tree Peony Bark according to the formula, mix, and crush to obtain crude medicinal powder;

[0078] (2) Put the crude medicinal powder of step (1) into an ultrasonic extractor, add 6 times the amount of 60% ethanol, and ultrasonically extract for 40 minutes. The extraction conditions are: temperature 35°C, ultrasonic power 1200 W per ultrasonic head, ultrasonic 2 seconds and pause 1 second. After ultrasonic extraction, centrifuge, and the centrifugal liquid is reserved for use. Add 5 times the amount of 20% ethanol to the residue, ultrasonically extract for 40 minutes under the same conditions, and after ultrasonic extraction, centrifuge. Combine the two centrifugal liquids and reduce pressure to concentrate to obtain a 1:10 (mass ratio of medicinal materials to extract) concentrated liquid; or further concentrate to obtain a thick paste;

[0079] (3) Put 5 parts of malt dextrin into a fluid bed granulator, and then spray the thick paste of step (2) to perform one-step granulation. The granulation conditions are: inlet temperature 102°C, material temperature 60°C, outlet temperature 45-50°C, and atomization pressure 0.22 MPa. The relative density of the thick paste of step (2) is 1.08-1.1 (50°C). After spray drying, take out the granules, and the granules are obtained.

[0080] Example 6

[0081] A traditional Chinese medicine composition capable of inhibiting Malassezia and improving the symptoms of scalp pruritus, the effective ingredient of which is prepared from the following raw materials: Sophora flavescens 20 parts, Farfarae 5 parts, Clove 10 parts, and Tree Peony Bark 25 parts.

[0082] The above traditional Chinese medicine composition is prepared into finished products, including the following steps:

[0083] (1) According to the prescription amount, take Sophora flavescens, Stemona, Clove, Peony, mix, crush, and obtain crude powder of medicinal materials;

[0084] (2) The crude powder of medicinal materials in step (1) is soaked in 2 times of 50% ethanol for one night (more than 12 hours), then transferred to a percolation extraction tank, 15 times of 50% ethanol is added, and percolation extraction is carried out. The percolation speed is 20 ml / (min*kg of medicinal materials). After percolation, the extract is concentrated under reduced pressure to obtain a concentrated solution with a ratio of 1:10 (mass ratio of medicinal materials to extract); or further concentrated to obtain a thick paste;

[0085] (3) The thick paste in step (2) is dried in a vacuum drying oven. The drying conditions are: temperature 75°C, vacuum degree -0.085Mpa. After drying, it is taken out and crushed to obtain dry paste powder;

[0086] (4) The dry paste powder obtained in step (3) is granulated by adding an appropriate amount of excipients to obtain granules.

[0087] Example 7

[0088] A traditional Chinese medicine composition capable of inhibiting Malassezia and improving the symptoms of scalp pruritus, the effective ingredient is prepared from the following raw materials: Sophora flavescens 20 parts, Stemona 10 parts, Clove 10 parts, Peony 20 parts.

[0089] The above traditional Chinese medicine composition is prepared into finished products, including the following steps:

[0090] (1) According to the prescription amount, take Sophora flavescens, Stemona, Clove, Peony, mix, crush, and obtain crude powder of medicinal materials;

[0091] (2) The crude powder of medicinal materials in step (1) is placed in an ultrasonic extractor, 6 times of 30% propylene glycol is added, and ultrasonic extraction is carried out for 40 minutes. The extraction conditions are: temperature 35°C, ultrasonic power: 1200 watts per single ultrasonic head, ultrasonic 2 seconds and stop 1 second. After ultrasonic extraction, centrifugation is carried out. The centrifugal liquid is reserved for use, and the residue is added with 5 times of 10% propylene glycol, ultrasonic extraction is carried out for 40 minutes under the same conditions, and after ultrasonic extraction, centrifugation is carried out. The two centrifugal liquids are combined, and an appropriate amount of purified water is added to adjust to an extract with a ratio of 1:10 (mass ratio of medicinal materials to extract) (without further concentration).

[0092] Comparative Example 1

[0093] Compared with Example 7, except that Peony is not added to the traditional Chinese medicine part, the rest is prepared according to the method of Example 7 to obtain Comparative Example 1 sample 1:15 concentrated solution (to ensure that the concentrations of Sophora flavescens, Stemona and Clove in the extract are the same as those in Example 7).

[0094] Comparative Example 2

[0095] Compared with Example 7, the Chinese medicine part only added Cortex Moutan, and the rest was prepared according to the method of Example 7 to obtain Sample 1 of Comparative Example 2: 30 concentrated solution (to ensure that the concentration of Cortex Moutan in the extraction solution is the same as that of Example 7).

[0096] Effect implementation example

[0097] I. Malassezia bacteriostatic test

[0098] 1 Principle

[0099] The inhibition rate of the sample pair on Malassezia was calculated by measuring the OD value method through the co-culture system to investigate the Malassezia bacteriostatic effect of the sample pair.

[0100] 2 Experimental method

[0101] 2.1 Materials and reagents

[0102] Malassezia chromogenic medium (without agar, Liaoyi Biology), 15mm test tube with silica gel plug, 50mL conical flask, 1mL gun head and pipette gun, weighing spoon, enzyme-labeled plate, enzyme-labeled instrument, ketonecongchao tablet (Xi'an Yangsen Pharmaceutical Co., Ltd.).

[0103] 2.2 Pathogenic strain

[0104] Malassezia furfur (ATCC 44344), Guangdong Microbial Culture Collection Center.

[0105] 2.3 Test product

[0106] Example 1-1:10 concentrated solution (extraction solution) of sample No. 7 and comparative example sample.

[0107] 2.4 Preparation of pathogenic bacteria solution

[0108] Malassezia furfur was cultured with Malassezia chromogenic medium and incubated at 36℃±1℃ for 60-72 hours to make its final concentration in the experimental system reach 10 5 CFU / mL or more.

[0109] 2.5 Preparation of bacterial suspension

[0110] Malassezia furfur solution was diluted with Malassezia chromogenic medium to make its final concentration in the experimental system reach 10 5 CFU / mL.

[0111] 2.6 Sample bacteriostatic test

[0112] Refer to MIC experimental method for operation. The experimental system is 2 mL, 1 ml of Malassezia furfur liquid is added, the addition amount of the sample to be tested is set to 20% concentration, and negative and positive controls are made. The test is carried out in a test tube with a stopper as a container. After mixing the liquid, shake well, use a sterile pipette to take 100 μL of the mixed liquid into an enzyme-labeled plate, and use an enzyme-labeled instrument to measure the initial OD 600 absorbance value. Continue to culture for 60 h, use a sterile pipette to take 100 μL of the mixed liquid into an enzyme-labeled plate, and use an enzyme-labeled instrument to measure the OD 600 absorbance value of the mixed liquid cultured for 60 h.

[0113] Use 20% propylene glycol sterilization solution + Malassezia furfur liquid as a benchmark control, sterile Malassezia furfur chromogenic medium as a blank control, untreated Malassezia furfur liquid as a negative control, and ketoneconazole solution + Malassezia furfur liquid as a positive control.

[0114] II. Mouse auricle swelling experiment

[0115] Principle: Apply the sample to the left ear of the mouse, apply the blank solvent to the right ear, then apply dimethylbenzene to both ears to cause inflammation, and compare the swelling degree of both ears to determine the anti-inflammatory effect of the sample.

[0116] Animal source: Select Kunming mice from the animal experiment center of the Southern Medical University, with a body weight of 18-22 g, half male and half female, and an age of 6-8 weeks. The experimental animals are pre-fed for 2 days to adapt to the environmental conditions of the animal room.

[0117] Fluocinolone acetonide cream (Tianjin Pacific Pharmaceutical Co., Ltd., batch number: 8422139), dimethylbenzene (Xilong Science, analytical pure), 75% ethanol.

[0118] Experimental method

[0119] The experimental mice were randomly divided into 11 groups, 8 mice in each group, which were blank control group, positive control group (fluocinolone ointment), example groups 1-7 and comparative example groups 1 and 2. The animals in each group were applied with the test drug on the left ear, the positive group was applied with fluocinolone according to the amount of 0.25 g / kg, and the example groups 1-7 and the comparative example groups 1 and 2 were applied with the sample according to the amount of 0.25 ml / kg per mouse. The right ears of the 11 groups of mice were applied with the matrix or solvent of the corresponding test drug as a blank control. After 60 min, 2 drops of dimethylbenzene were applied to the front and back of both ears of each test animal to cause inflammation. 120 min after the inflammation, the mice were killed by dislocation. The two ears were cut off, and a circular ear piece was punched out from the same part of both ears with a punch with a diameter of 8 mm, and immediately weighed on a balance. The weight difference between the left and right ears was compared. The greater the difference, the better the anti-inflammatory effect of the sample.

[0120] III. Human trial experiment

[0121] Test Sample: Take the sample from Example 7, add purified water (to eliminate other interferences), and prepare a 20% concentration of anti-dandruff and anti-itch essence; Target Population: Men with dandruff and itchy scalp, with hair cut into short styles of roughly uniform length (longer hair will consume too much anti-dandruff essence, affecting the consistency of usage); Usage: Use daily. Before shampooing, apply 2ml to the scalp, then shampoo with Pantene Ginseng Nourishing Shampoo (without anti-dandruff agent), allowing the foam to work for about 3 minutes, then rinse with water. After shampooing, apply another 2ml evenly to the scalp and massage for 2 minutes. After 7 consecutive days of use, discontinue the anti-dandruff and anti-itch essence, but continue to shampoo with Pantene Ginseng Nourishing Shampoo once a day to observe the subsequent effects.

[0122] Results and Analysis

[0123] Results of experiments on the inhibition of Malassezia furfur by different samples

[0124] The results of the experiments on the inhibition of Malassezia furfur by different samples are shown in Table 1.

[0125] Table 1. Experiments on the inhibition of Malassezia furfur by samples.

[0126]

[0127]

[0128] Notes: (1) For the samples in Examples 1-6, after appropriate concentration, 20% propylene glycol was added to adjust the concentration to 1:10 (medicinal material: extract) to eliminate the interference caused by different solvents; (2) Three samples were prepared for each group of experiments; (3) Ketoconazole solution was prepared from ketoconazole tablets.

[0129] As shown in Table 1, when the concentration of samples in Examples 1-7 was 20%, they all had an inhibitory effect on Malassezia furfur. Samples extracted with different concentrations of ethanol or propylene glycol were superior to those extracted with water. Samples extracted by ultrasound / ultra-high pressure were superior to those extracted by percolation. The inhibition rates of Comparative Example 1 and Comparative Example 2 were lower than those of Example 7, and Comparative Example 2 had the lowest antibacterial rate.

[0130] The results of the antibacterial test show that:

[0131] (1) The antibacterial components in the formula are more effective when extracted with alcohol;

[0132] (2) Although the antibacterial effect of peony bark is the worst, it has a synergistic effect on the antibacterial effect of sophora flavescens, stemona japonica and clove. Under the combined effect, the antibacterial effect is better than that of the sample without peony bark.

[0133] (3) Samples in Examples 4, 5 and 7 are close to the positive ketoconazole control, with sample 7 showing the best antibacterial effect.

[0134] Results of mouse ear swelling test

[0135] The results of the mouse auricle swelling experiment are shown in Table 2.

[0136] Table 2, effect of different samples on mouse auricle swelling

[0137]

[0138] From Table 2, it can be seen that:

[0139] (1) The anti-inflammatory components in the formula are better extracted with alcohol-containing solvents, and the best recovery of the solvent is achieved by direct ultrasonic cold extraction, and high temperature will cause loss of part of the anti-inflammatory components;

[0140] (2) The 7 samples are comparable to the positive fluorocortisone ointment control, and Examples 4 and 6 are slightly worse;

[0141] (3) The control 1 sample has slightly poor anti-inflammatory effect, but has a synergistic effect with the cortex moutan anti-inflammatory effect, and the combined effect is better than that of the cortex moutan sample alone.

[0142] Results of human trial experiments

[0143] The human trial experiment is shown in Table 3.

[0144] Table 3, comparison of dandruff effects of different samples

[0145]

[0146] Notes: (1) In the effective rate statistics, using for 3 days has dandruff or itching relief is effective, and more than 3 days is effective, which is counted as ineffective; (2) The method for confirming whether there is dandruff is that the user combs the head on a piece of white paper, combs each area 3 times in the opposite direction, and observes whether there is dandruff falling on the white paper. If there is little dandruff, 1-3 pieces, falling, it is counted as no dandruff; (3) The trial population using the original compound ketoconazole lotion for hair is used according to the instructions, with a frequency of 2 times a week.

[0147] From Table 3, it can be seen that:

[0148] (1) The population that has not used dandruff and itching products before is 100% effective in dandruff and itching relief with this product, which may be because they have not used similar products before and have not developed drug resistance, or it may be because their dandruff and itching symptoms are relatively mild and they can tolerate the original products, or both;

[0149] (2) For the population that has used dandruff agents, the effective rate of this product is more than 80%, and the comprehensive statistics show that the dandruff effect is 91.1% and the itching effect is 87.5%, and the population counted as ineffective has also been relieved in dandruff and itching;

[0150] (3) Compared with ZPT, OCT, ketoconazole and other dandruff products, the trial users use other products at least once a day except for ketoconazole which can be used more than once a day for 2 days, and some users use them every day but still have poor effects. According to the comparison between the trial users before and after the use, the product can at least achieve the use effect of ketoconazole;

[0151] (4) In terms of long-term effects, some people can be counted as cured, and they have no dandruff and itching for more than 3 days;

[0152] (5) According to the subsequent use willingness statistics, most people are willing to continue to use the product, and a small number of people who are not willing to continue to use the product think that "there is no dandruff, and it is not necessary to use it again", which shows that the product has good effects, and if it is put into the market, it will have good market performance and benefit the patients with dandruff and itching.

[0153] In summary, the product takes into account the effects of dandruff and itching relief, and takes into account the dandruff function (kurch root, root of baeckia and clove inhibit Pityrosporum ovale) and the itching relief function (peony has strong anti-inflammatory function, thereby achieving the effect of itching relief) in the formula, and the two show mutual promotion in the bacteriostatic and pharmacological tests, achieving the unexpected effect, and having good creativity and innovation.

[0154] The above is a further detailed description of the present application, which cannot be regarded as a limitation on the specific implementation of the present application. For ordinary skilled persons in the technical field to which the present application belongs, simple deduction or replacement without departing from the concept of the present application is within the protection scope of the present application.

Claims

1. A composition wherein the active ingredient is derived from Sophora flavescens, Stemona japonica, clove, and Paeonia suffruticosa, in a mass ratio of 10-30 parts Sophora flavescens, 5-15 parts Stemona japonica, 5-15 parts clove, and 10-30 parts Paeonia suffruticosa, wherein the active ingredient is a solvent extract, supercritical extract, or powder of the raw material, and the solvent is selected from at least one of water, alcohol, and nonpolar solvents.

2. The composition according to claim 1, characterized in that, The alcohol is selected from ethanol, propylene glycol, 1,3-propylene glycol, and butanediol.

3. The composition according to claim 1, characterized in that, The composition is a lotion, serum, conditioner, or ointment.

4. The use of the composition according to any one of claims 1 to 3 in the preparation of a scalp itch relief agent.

5. The use of the composition according to any one of claims 1 to 3 in the preparation of anti-dandruff products.

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