阅读说明：本技术 一种基于固体分散技术的头皮抑菌消炎组合物及其制备方法 (Scalp antibacterial and anti-inflammatory composition based on solid dispersion technology and preparation method thereof ) 是由 魏磊 王志尧 王伟 常霞 王韬 周雍 姜晓 陈欣 李晓 于 2021-10-14 设计创作，主要内容包括：本发明涉及一种基于固体分散技术的头皮抑菌消炎组合物,其由下述配比的原料组成：姜黄素25-50 mg、胡椒碱25-50 mg、PVP K30 300-600 mg、大豆卵磷脂50-100 mg,有机溶剂20-25 ml。该组合物对导致头屑、头痒的2种真菌(糠秕马拉色氏菌Malassezia furfur)、限制马拉色氏菌Malassezia restricta)、2种细菌(表皮葡萄球菌(Staphylococcus epidermidis、痤疮丙酸杆菌(Propionibacterium acues)及5种常见人体致病菌有较强的抑制作用,且对皮肤无明显的刺激作用,不仅可以防治头皮部位的瘙痒、头屑,还可以作为其他皮肤部位的抑菌剂,能应用于洗发膏(水)、抑菌液、抑菌凝胶等。(The invention relates to a scalp bacteriostatic and anti-inflammatory composition based on a solid dispersion technology, which consists of the following raw materials in parts by weight: 25-50 mg of curcumin, 25-50 mg of piperine, 30300-600 mg of PVP K, 50-100 mg of soybean lecithin and 20-25 ml of organic solvent. The composition can be used for treating dandruff and scalp itching caused by 2 fungi (Malassezia furfur) Malassezia furfur ) Marasmius restrictus Malassezia restricta ) 2 kinds of bacteria (Staphylococcus epidermidis: (A)) Staphylococcus epidermidis Propionibacterium acnes (A), (B), (C) Propionibacterium acues ) And 5 common human pathogenic bacteria have stronger inhibiting effect and no obvious stimulation to skin, can prevent and treat pruritus and dandruff of scalp parts, can also be used as bacteriostatic agents of other skin parts, and can be applied to shampoo (water), bacteriostatic solution, bacteriostatic gel and the like.)

1. A scalp bacteriostatic and anti-inflammatory composition based on a solid dispersion technology is characterized by comprising the following raw materials in parts by weight: 25-50 mg of curcumin, 25-50 mg of piperine, 30300-600 mg of PVP K, 50-100 mg of soybean lecithin and 20-25 ml of organic solvent.

2. The method for preparing scalp antibacterial and anti-inflammatory composition based on solid dispersion technology as claimed in claim 1, is characterized in that curcumin, piperine, PVP K30 and soybean lecithin are added into organic solvent according to a certain proportion, stirred until completely dissolved, and the solvent is recovered under reduced pressure at 45-60 ℃ until dried, thus obtaining the scalp antibacterial and anti-inflammatory composition.

3. A method for preparing a scalp bacteriostatic and anti-inflammatory composition based on a solid dispersion technology according to claim 2, wherein the organic solvent is methanol, acetone, absolute ethanol or 95% ethanol.

4. A shampoo paste containing the scalp antibacterial and anti-inflammatory composition of claim 1 is characterized by comprising the following raw materials in parts by weight: 8-15 parts of scalp antibacterial and anti-inflammatory composition, 60-80 parts of water, 10-14 parts of ammonium laureth sulfate, 4-6 parts of cocamidopropyl betaine, 2-4 parts of sodium lauroyl sarcosinate, 1-2 parts of PEG-7 glyceryl cocoate, 1-3 parts of cocamide MEA, 1-3 parts of ethylene glycol distearate, 1-2 parts of sodium hyaluronate, 70.1-0.3 part of polyquaternary ammonium salt, 730.1-0.3 part of polyquaternary ammonium salt, 0.1-0.3 part of allantoin, 0.1-0.3 part of ethylparaben and 0.1-0.3 part of methylisothiazolinone.

5. The method for preparing the shampoo cream as claimed in claim 4, wherein the scalp antibacterial and anti-inflammatory composition is mixed with water in proportion, after the mixture is heated to 65-75 ℃, ammonium laureth sulfate, sodium lauroyl sarcosinate and cocamidopropyl betaine are added, then the temperature is raised to 80-85 ℃ and kept for 0.5-1h, the temperature is lowered to below 50 ℃, PEG-7 glyceryl cocoate, cocamide MEA, ethylene glycol distearate, sodium hyaluronate, polyquaternary ammonium salt-7, polyquaternary ammonium salt-73, allantoin, ethylparaben and methylisothiazolinone are added, and the mixture is stirred uniformly, thus obtaining the shampoo cream.

Technical Field

The invention belongs to the technical field of biochemistry, and particularly relates to a broad-spectrum scalp antibacterial and anti-inflammatory composition based on a co-amorphous solid dispersion technology and a preparation method thereof.

Background

Itching of the head and much dandruff always bother many people. Modern pharmacological studies show that: the imbalance of flora and abnormal reproduction of pathogenic bacteria are important reasons for causing pruritus and dandruff. Two common fungi in the scalp are malassezia furfurMalassezia furfur) Marasmius restrictusMalassezia restricta) Two common bacteria are Staphylococcus epidermidis ((S))Staphylococcus epidermidis) Propionibacterium acnes (A), (B), (C)Propionibacterium acues). Wherein Malassezia serrata is one of resident flora (also conditional pathogenic bacteria) on human skin surface, can be cultured from 97% of normal human skin, and causes diseases under various promotion factors, such as tinea versicolor, folliculitis, and dandruff. When the number of malassezia is within the normal range, keratinization of epidermal cells of the skin of the head is also in a normal metabolic process; when the sebum secretion of the head is vigorous, malassezia will breed abnormally, and when the sebum secretion accounts for about 75% of the total microbial community content, the lipophilicity greatly reduces the content of saturated fatty acid in the sebum layer of the scalp, accelerates the aging and falling of the cuticle, and ensures that the fallen cuticle cells are tightly adhered together through intercellular adhesion substances. Most of these stratum corneum cells are not shed individually, but are separated from the scalp in aggregates of varying sizes of tens or even hundreds of cells. When the diameter is more than 0.2mm, dandruff can be observed by naked eyes, and small-piece aggregates can be clinically observed and are called as dandruff. In human scalp with more dandruff, propionibacterium acnes accounts for 50% while staphylococcus aureus accounts for 44%.

Curcumin and piperine are both derived from plant natural products, wherein curcumin is a polyphenol compound extracted from a zingiberaceae plant, and the activity research mainly focuses on anticancer, antioxidant and liver protection at present. Piperine is the highest chemical component in pepper content and activity, and the activity research is mainly focused on the effects of antioxidation, blood fat reduction and tumor resistance at present. Meanwhile, the research shows that the piperine is also an ideal biological activity enhancer. Curcumin has low water solubility, is unstable under physiological conditions, and is metabolized rapidly in vivo, so that curcumin is easy to eliminate in vivo, and the application of curcumin is limited due to extremely low bioavailability. The piperine and curcumin are combined for application, so that the blood concentration of curcumin can be increased, the elimination half-life period can be prolonged, the metabolic clearance rate can be reduced, and the bioavailability can be improved. However, the study of the combination of curcumin and piperine for resisting head fungi and bacteria has not been reported yet.

Disclosure of Invention

The broad-spectrum scalp antibacterial and anti-inflammatory composition aims to overcome the defects of the prior art, and is based on a co-amorphous solid dispersion technology. The composition has the advantages of mild, long-acting, and no irritation, and can be widely used in skin and hair cleaning and caring topical preparation for human and animal such as shampoo, hand lotion (cream or gel), and animal skin and hair cleanser.

The invention also provides a preparation method of the broad-spectrum scalp antibacterial and anti-inflammatory composition based on the co-amorphous solid dispersion technology.

A scalp bacteriostatic and anti-inflammatory composition based on a solid dispersion technology comprises the following raw materials in parts by weight: 25-50 mg of curcumin, 25-50 mg of piperine, 30300-600 mg of PVP K, 50-100 mg of soybean lecithin and 20-25 ml of organic solvent.

The invention provides a preparation method of the scalp antibacterial and anti-inflammatory composition based on the solid dispersion technology, which comprises the following steps: adding curcumin, piperine, PVP K30 and soybean lecithin into an organic solvent according to a certain proportion, stirring until the curcumin, the piperine, the PVP K30 and the soybean lecithin are completely dissolved, and recovering the solvent to be dry at a temperature of between 45 and 60 ℃ under reduced pressure (-0.08 to-0.1 mPa), thus obtaining the amorphous solid dispersion.

Further, the organic solvent may be methanol, acetone, absolute ethanol or 95% ethanol, etc.

The invention also provides a shampoo paste containing the scalp antibacterial and anti-inflammatory composition, which is prepared from the following raw materials in parts by weight: 8-15 parts of scalp antibacterial and anti-inflammatory composition, 60-80 parts of water, 10-14 parts of ammonium laureth sulfate, 4-6 parts of cocamidopropyl betaine, 2-4 parts of sodium lauroyl sarcosinate, 1-2 parts of PEG-7 glyceryl cocoate, 1-3 parts of cocamide MEA, 1-3 parts of ethylene glycol distearate, 1-2 parts of sodium hyaluronate, 70.1-0.3 part of polyquaternary ammonium salt, 730.1-0.3 part of polyquaternary ammonium salt, 0.1-0.3 part of allantoin, 0.1-0.3 part of ethylparaben and 0.1-0.3 part of methylisothiazolinone.

The invention provides a preparation method of the shampoo, which comprises the following steps: mixing the scalp antibacterial and anti-inflammatory composition with water according to a proportion, heating to 65-75 ℃, adding ammonium laureth sulfate, sodium lauroyl sarcosinate and cocamidopropyl betaine, then heating to 80-85 ℃, keeping the temperature for 0.5-1h, cooling to below 50 ℃, adding PEG-7 glyceryl cocoate, cocamide MEA, ethylene glycol distearate, sodium hyaluronate, polyquaternary ammonium salt-7, polyquaternary ammonium salt-73, allantoin, ethylparaben and methylisothiazolinone, and uniformly stirring to obtain the scalp antibacterial and anti-inflammatory composition.

Experiments prove that the antibacterial effect is greatly improved after the curcumin and the piperine are combined, but the curcumin and the piperine have poor water solubility and are difficult to play roles when used as external products, so that the curcumin and the piperine are prepared into an amorphous solid dispersant to improve the water solubility.

The invention aims at human scalp microbial flora (two representative groups of fungi are Malassezia furfur and Malassezia limited resticta) and two groups of bacteria (Staphylococcus epidermidis and Propionibacterium acnes) to observe and compare the antibacterial effect of the paste shampoo prepared by the traditional Chinese medicine composition and two famous common paste shampoos. The experimental results show that: the cream shampoo prepared from the traditional Chinese medicine composition provided by the invention has stronger in-vitro inhibition effect on four common scalp strains, better antibacterial effect, obvious bacteriostatic action on five other common pathogenic bacteria of human bodies and good broad-spectrum antibacterial property. Meanwhile, the skin allergy experiment of the guinea pig is carried out (according to the national standard GB/T21608-: skin adverse reactions such as erythema, edema and the like do not occur after allergic contact and excitation experiments of the guinea pigs in an experimental group using the traditional Chinese medicine composition, the guinea pigs have no any adverse reactions such as tachypnea, unstable limbs, abnormal aggressivity and the like, the incidence rate of allergic reactions is 0, and the shampoo has no sensitization to the skin of the guinea pigs. The skin on the left back of the guinea pig of the positive control group can be obviously seen with red spots and unhairing after sensitization, after the test object is removed after excitation, the skin on the right back of the guinea pig can be seen with diffuse red spots, and the anaphylactic reaction incidence rate is 100%, which indicates that the 2, 4-para-dinitrochlorobenzene is the V-grade strong sensitizer.

Compared with the prior art, the technical scheme of the invention has the following beneficial effects:

1) the traditional Chinese medicine composition has obvious antibacterial and anti-inflammatory effects, has the characteristics of safe medication, obvious curative effect, less side effect of clinical application, wide application population, convenient use and the like, and can be used for treating symptoms such as skin itching, dandruff increase and the like;

2) the invention performs antibacterial experiments of four main microbial floras of human scalp and five common pathogenic bacteria of human. The test results show that: the traditional Chinese medicine composition provided by the invention has a good inhibition effect on the experimental fungi and bacteria;

3) the present invention has conducted a guinea pig skin allergy test. Test results show that the traditional Chinese medicine composition provided by the invention has no irritation and anaphylactic reaction to skin.

Drawings

FIG. 1 is a graph showing the results of DPPH radical scavenging ability test on samples prepared in various examples;

FIG. 2 is a graph of the results of ABTS free radical scavenging ability test on samples prepared in various examples;

figure 3 groups of guinea pigs were sensitized to test for changes in back skin.

Detailed Description

The technical solution of the present invention is further described in detail with reference to the following examples, but the scope of the present invention is not limited thereto.

In the invention, the selected raw materials are all common commercial products which can be bought in the market.

Example 1

A scalp bacteriostatic and anti-inflammatory composition based on a solid dispersion technology comprises the following raw materials in parts by weight: curcumin 25mg, piperine 25mg, PVP K30300 mg, soybean lecithin 50mg, and organic solvent 95% ethanol-water solution 20 ml.

The preparation method of the scalp antibacterial and anti-inflammatory composition based on the solid dispersion technology comprises the following steps: adding curcumin 25mg, piperine 25mg, PVP K30300 mg and soybean lecithin 50mg into 20ml 95% ethanol-water solution, stirring at room temperature for 30min until completely dissolved, and recovering solvent at 55 deg.C under reduced pressure (-0.09 mPa) to dry to obtain scalp antibacterial and antiinflammatory composition, which is curcumin and piperine co-amorphous solid dispersion.

The invention also provides a shampoo paste containing the scalp antibacterial and anti-inflammatory composition, which is prepared from the following raw materials in parts by weight: 10 parts of scalp antibacterial and anti-inflammatory composition, 70 parts of water, 12 parts of ammonium laureth sulfate, 5 parts of cocamidopropyl betaine, 3 parts of sodium lauroyl sarcosine, 2 parts of PEG-7 glyceryl cocoate, 3 parts of cocamide MEA, 2 parts of ethylene glycol distearate, 1 part of sodium hyaluronate, 70.1 parts of polyquaternary ammonium salt, 730.1 parts of polyquaternary ammonium salt, 0.1 part of allantoin, 0.1 part of ethylparaben and 0.1 part of methylisothiazolinone.

The invention provides a preparation method of the shampoo, which comprises the following steps: mixing the scalp antibacterial and anti-inflammatory composition with water according to a proportion, heating to 70 ℃, adding ammonium laureth sulfate, sodium lauroyl sarcosinate and cocamidopropyl betaine, then heating to 82 ℃, keeping the temperature for 1h, cooling to below 50 ℃, adding PEG-7 glyceryl cocoate, cocamide MEA, ethylene glycol distearate, sodium hyaluronate, polyquaternary ammonium salt-7, polyquaternary ammonium salt-73, allantoin, ethylparaben and methylisothiazolinone, and uniformly stirring to obtain the scalp antibacterial and anti-inflammatory composition.

Example 2:

a scalp bacteriostatic and anti-inflammatory composition based on a solid dispersion technology comprises the following raw materials in parts by weight: 40mg of curcumin, 40mg of piperine, 80mg of PVP K30500, and 25ml of absolute ethyl alcohol serving as an organic solvent.

The preparation method of the scalp antibacterial and anti-inflammatory composition based on the solid dispersion technology comprises the following steps: adding curcumin 40mg, piperine 40mg, PVP K30500 mg and soybean lecithin 80mg into 25ml absolute ethyl alcohol, stirring at room temperature for 40min until completely dissolving, and recovering solvent at 55 deg.C under reduced pressure (-0.09 mPa) until dry to obtain scalp antibacterial and antiinflammatory composition, which is curcumin and piperine co-amorphous solid dispersion.

The invention also provides a shampoo paste containing the scalp antibacterial and anti-inflammatory composition, which is prepared from the following raw materials in parts by weight: 10 parts of scalp antibacterial and anti-inflammatory composition, 70 parts of water, 12 parts of ammonium laureth sulfate, 5 parts of cocamidopropyl betaine, 3 parts of sodium lauroyl sarcosine, 1 part of PEG-7 glyceryl cocoate, 2 parts of cocamide MEA, 3 parts of ethylene glycol distearate, 1 part of sodium hyaluronate, 70.2 parts of polyquaternary ammonium salt, 730.3 parts of polyquaternary ammonium salt, 0.3 part of allantoin, 0.2 part of ethylparaben and 0.2 part of methylisothiazolinone.

The shampoo was prepared according to example 1.

Example 3:

a scalp bacteriostatic and anti-inflammatory composition based on a solid dispersion technology comprises the following raw materials in parts by weight: 30mg of curcumin, 50mg of piperine, PVP K30400 mg, 70mg of soybean lecithin and 20ml of organic solvent acetone.

The preparation method of the scalp antibacterial and anti-inflammatory composition based on the solid dispersion technology comprises the following steps: adding curcumin 30mg, piperine 50mg, PVP K30400 mg and soybean lecithin 70mg into 20ml acetone, stirring at room temperature for 40min until completely dissolving, and recovering solvent at 55 deg.C under reduced pressure (-0.09 mPa) to dry to obtain scalp antibacterial and antiinflammatory composition which is curcumin and piperine co-amorphous solid dispersion.

The invention also provides a shampoo paste containing the scalp antibacterial and anti-inflammatory composition, which is prepared from the following raw materials in parts by weight: 15 parts of scalp antibacterial and anti-inflammatory composition, 80 parts of water, 12 parts of ammonium laureth sulfate, 5 parts of cocamidopropyl betaine, 3 parts of sodium lauroyl sarcosine, 1 part of PEG-7 glyceryl cocoate, 1 part of cocamide MEA, 1 part of ethylene glycol distearate, 2 parts of sodium hyaluronate, 70.3 parts of polyquaternary ammonium salt, 730.2 parts of polyquaternary ammonium salt, 0.2 part of allantoin, 0.3 part of ethylparaben and 0.3 part of methylisothiazolinone.

The shampoo was prepared according to example 1.

Application test 1: bacteriostatic activity test (zone of inhibition)

The experiment refers to the indication experiment of the inhibition zone of Oxford cup method recommended by the American clinical standards Committee (NCCLS). Selecting 2 fungi (malassezia furfur) which cause itching and scurf due to unbalanced reproduction in human scalpMalassezia furfurAnd restriction of MalasseziaMalassezia restricta) 2 bacteria (Staphylococcus epidermidis)Staphylococcus epidermidisPropionibacterium acnesPropionibacterium acues) And other common 2 kinds of pathogenic bacteria (E.coli)Escherichia coli.Staphylococcus aureusStaphylococcus aureus) In total, 6 kinds of microorganisms were used as test strains, mother liquor (400 mg/mL) with a certain concentration was prepared from the shampoo containing the scalp antibacterial and anti-inflammatory composition prepared in the above examples 1-3 as a test sample, and a commercially available moisturizing and dandruff removing shampoo-Piorubie as a control, and sterilized solid medium plates with a diameter of 9 cm were taken and 0.3 mL of 10 concentration was aspirated⁶-10⁸ CFU/mL of the bacterial suspension was uniformly spread on a plate, and then a shampoo mother liquor (200 μ L) containing the scalp antibacterial and anti-inflammatory composition prepared in examples 1 to 3 was sucked and placed in an oxford cup in a medium, followed by culturing in an incubator at a constant temperature (30 ℃ for fungi or 37 ℃ for bacteria) for 24 hours, and the diameter (mm) of the zone of inhibition was measured, and the average value was taken 3 times in parallel. The results are given in table 1 below.

TABLE 1 examples prepared samples with zone of inhibition size

As can be seen from the data in Table 1, the diameters of the zones of inhibition in examples 1 to 3 were larger than those of the moisturizing and anti-dandruff shampoo-Piaorou commercially available. It is demonstrated that although some commercially available shampoos have certain bacteriostatic effects, examples 1-3 have stronger antibacterial effects, more obvious effects, and better and higher broad-spectrum antibacterial properties. The inhibiting effect on the malassezia is the most obvious, and the inhibiting effect on the staphylococcus aureus is the second time. This indicates that the shampoos prepared in examples 1-3 containing the scalp antibacterial and anti-inflammatory composition have good antibacterial effects, and can improve the problem of itching and scurf of the scalp caused by excessive proliferation of scalp microorganisms.

Application test 2: free radical scavenging Activity test (DPPH and ABTS)

DPPH is a stable free radical, which is dark purple when added to an ethanol solution, and which reacts with an antioxidant to discolor, the degree of discoloration reflecting the antioxidant-removing ability, so that the antioxidant-resisting ability can be measured spectrophotometrically at a wavelength of 519 nm by measuring the change in absorbance value after the color has become light as a result of the antioxidant-removing DPPH. The experiment adopts spectrophotometry to carry out quantitative analysis, the free radical scavenging capacity of the shampoo containing the scalp antibacterial and anti-inflammatory composition prepared in the examples 1-3 is detected, and the higher the scavenging rate is, the stronger the free radical scavenging and oxidation resisting capacity is. The test results are shown in fig. 1.

ABTS free radical is stable, and the addition of ethanol solution shows dark purple red, and has maximum absorption peak at 734 nm. When an antioxidant is added, the monomer is paired, the solution fades, and the absorbance at 734 nm decreases. The antioxidant capacity of the antioxidant to scavenge ABTS free radicals was therefore measured spectrophotometrically. The experiment adopts spectrophotometry to carry out quantitative analysis, the free radical scavenging capacity of the shampoo containing the scalp antibacterial and anti-inflammatory composition prepared in the examples 1-3 is detected, and the higher the scavenging rate is, the stronger the free radical scavenging and oxidation resisting capacity is. The test results are shown in fig. 2.

From the results of FIGS. 1 and 2, it is understood that examples 1 to 3 exhibited strong antioxidant activity and dose dependence, although the radical scavenging action was inferior to that of gallic acid, which is a strong antioxidant. And all of examples 1 to 3 exert a better free radical scavenging action than the shampoo paste comprising the scalp bacteriostatic anti-inflammatory composition. This indicates that the shampoo containing the scalp bacteriostatic and anti-inflammatory composition prepared in examples 1 to 3 has a good antioxidant effect.

Application test 3: test for anti-inflammatory Activity

The experiment uses xylene-induced auricular swelling method to study the shampoo containing the scalp antibacterial and anti-inflammatory composition prepared in examples 1-3: 40 mice were randomly and evenly divided into 4 groups, which were: control group (applying distilled water), cream shampoo (0.5g/mL) containing scalp bacteriostatic and anti-inflammatory composition prepared in examples 1-3. The front and back sides of the left and right ears of each group of mice were coated with the drug 1 time, and the control group was coated with the same amount of distilled water for 7 days. 1h after the last dose, 0.1 mL of xylene was applied to the upper and lower right ear of the mouse, and the left ear was used as a reference. And (3) after 1h, dislocating and killing the cervical vertebra of the mouse, punching a circular lug plate at the same position of two lugs by using a puncher with the diameter of 8mm, precisely weighing the mass, and respectively calculating the auricle swelling rate and the swelling inhibition rate of the mouse by using the following formulas. The results are shown in Table 2.

Swelling rate (%) = (right ear mass-left ear mass)/left ear mass × 100%

Swelling inhibition (%) = (control ear swelling rate-administration group ear swelling rate)/control ear swelling rate × 100%

TABLE 2 inhibition of swelling in mice of different groups

The animals in each experimental group were studied and it was found that the ears of mice with xylene-coated sides quickly developed different degrees of redness and swelling and blood vessels in the ear portions of the mice were clearly visible. Compared with a distilled water application group, the shampoo paste containing the scalp antibacterial and anti-inflammatory composition prepared in the examples 1 to 3 is applied for 7 days continuously, the red swelling and swelling degree is obviously reduced, the swelling inhibition rate is 48.9 to 51.6 percent, and good anti-inflammatory activity is shown.

Application test 4: safety test

The test is carried out according to the national standard GB/T21608-2008 chemical skin sensitization test method. 40 healthy adult white guinea pigs were divided into 4 groups at random, and the shampoo containing the scalp antibacterial and anti-inflammatory composition prepared in examples 1 to 3 and the positive control group (2, 4-p-dinitrochlorobenzene group) were used. Depilating the left back of guinea pig with electric hair clipper 24h before administration, depilating with depilating area of 7cm × 7cm, respectively smearing each sample 0.4g on central 2cm × 2cm of depilating area of each group of guinea pig, respectively covering with sterile patch after application, taking off the patch after 6h, cleaning with warm water, observing skin erythema and edema conditions 1h and 24h after removing the test substance, and determining whether there is systemic anaphylaxis such as unstable standing and shock, and scoring erythema and edema according to skin anaphylaxis scoring standard (see Table 3). The above administration was repeated for 3 times for each of 7d and 14 d. And calculating the average reaction score and the incidence rate of anaphylactic reaction. The extent of the allergic reaction was evaluated according to the skin allergy evaluation criteria (see Table 4).

Calculating the mean score of the response (mean score of response =)Sum of erythema score + sum of edema score)

Total number of animals

The incidence of allergic reactions (incidence of allergic reactions = calculation of allergic reaction rate)Number of animals with allergic reaction×100%）

Total number of animals

TABLE 3 skin sensitization test Scoring criteria

TABLE 4 grading evaluation criteria for skin sensitization test

The results are shown in FIG. 3 and tables 5 and 6. The skin on the left back of the guinea pig of the positive control group can be obviously seen with red spots and unhairing after sensitization, after the test object is removed after excitation, the skin on the right back of the guinea pig can be seen with diffuse red spots, and the anaphylactic reaction incidence rate is 100%, which indicates that the 2, 4-para-dinitrochlorobenzene is the V-grade strong sensitizer. The cream shampoo containing the scalp antibacterial and anti-inflammatory composition prepared in the examples 1 to 3 has no skin adverse reaction such as erythema and edema after being sensitized and excited by contacting with guinea pigs, the guinea pigs have no any adverse reaction such as tachypnea, unstable limbs and abnormal aggressivity, and the incidence rate of the allergic reaction is 0, which indicates that the cream shampoo containing the scalp antibacterial and anti-inflammatory composition prepared in the examples 1 to 3 has no sensitization to the skin of the guinea pigs.

TABLE 5 mean skin allergy scores

TABLE 6 evaluation of skin allergy

Application test 5: trial experiment of population

In this test, 30 subjects suffering from excessive dandruff were selected according to a ten-point rating method for adhesive dandruff, which is frequently used in foreign studies, and the changes in dandruff of the subjects before and after 4 weeks of use of the shampoo obtained in example 1 were compared with each other according to Table 7, and the subjects were self-evaluated. The results are shown in Table 7.

TABLE 7 adhesive dandruff Ten-grade scoring method and results

The results show that: selected 30 people suffering from dandruff include 20 people with dandruff levels of 3-4, 6 people with dandruff levels of 5-6, and 4 people with dandruff levels of 7-8. Through the use of four weeks, 7 of 20 cases of the patients suffering from grade 3-4 are changed into grade 0, 12 cases are changed into grade 1-2, and 1 case is not obviously improved; among 6 cases of 5-6 level puzzles, 1 case is changed into 1-2 level, 4 cases are changed into 3-4 level, and 1 case has no obvious improvement; 4 cases of those who are troubled by 7-8 stages, 3 cases are changed to 3-4 stages, and 1 case is changed to 5-6 stages. The obvious improvement rate is more than 93.3 percent. At the same time, the subjects evaluated themselves and improved the degree of scalp itching and dandruff production to different extents.