CN120899879A - A polypeptide combination formulation for anti-allergy, antipruritic, and treatment of inflammatory skin diseases. - Google Patents

Abstract

The invention relates to the technical field of medicines, in particular to a polypeptide combination preparation with anti-allergic, antipruritic, anti-inflammatory and repairing functions for treating skin inflammatory related diseases. The polypeptide combination preparation comprises compound peptide composed of acyl dipeptide-1, palmitoyl tripeptide-8, hexapeptide-9, tetrapeptide-3, palmitoyl tripeptide-5, dipeptide-15 and acetyl heptapeptide-4 and auxiliary materials. The polypeptide of the invention improves the skin inflammation problem from multiple dimensions such as immunoregulation, nerve signal blocking, barrier strengthening and the like through an anti-sensitization-antipruritic-repair three-in-one action mechanism. Compared with single component, the multi-target characteristic of the composition is safer and more efficient, has strong transdermal absorbability, and is suitable for being developed into external preparations (such as emulsion and essence) for treating skin diseases and daily care.

Description

Polypeptide combination preparation for resisting sensitization and relieving itching and treating skin inflammatory related diseases

Technical Field

The invention belongs to the technical field of polypeptide application, and in particular relates to a polypeptide combination preparation with anti-allergic, antipruritic, anti-inflammatory and repairing functions for treating skin inflammatory related diseases.

Background

Skin inflammatory related diseases such as eczema, dermatitis and the like are often accompanied with symptoms such as pruritus, red swelling, pain and the like, people work and rest are often influenced by the pruritus, patients often have symptoms such as insomnia, dysphoria and the like, when the pruritus lasts for 6 weeks or more, the pruritus is chronic pruritus, the other clinical manifestation of the chronic pruritus is repeated scratching behavior scratching-itching-scratching vicious circle, skin barrier is further damaged, microorganisms are more easily reproduced on the basis of skin damage, and further deterioration of the diseases is caused, so that the disease course is slow and is easy to repeatedly attack, and great physical and psychological pain and psychological burden are often brought to the patients to seriously influence the life quality of the patients. Therefore, attention has been paid more and more in recent years.

Itching is broadly divided into four major causes, dermatological, systemic, neuropathic and cardiac. Clinically usual treatments include hormonal and antihistaminic agents, substances used for anti-inflammatory purposes include non-steroidal types such as ibuprofen (ibuprofen) and indomethacin (indomethacin), and steroidal types such as dexamethasone (dexamethasone). However, the medicines have certain side effects and dependence, after the treatment is interrupted, pruritus can quickly recur, meanwhile, some medicines also contain antibiotics, which can inhibit beneficial bacteria in the body to cause unbalanced flora, and the traditional Chinese medicine has small side effects but slow effect. In this regard, there is a high necessity to develop safe anti-inflammatory drugs having maximum effect and minimum side effects.

The polypeptide substance has good biological activity, high specificity and low toxicity, such as acetyl dipeptide-1, palmitoyl tripeptide-8, has the functions of resisting inflammation, resisting wrinkle and maintaining skin barrier, and can effectively relieve symptoms of skin inflammatory related diseases. Suitable for mild to moderate skin inflammatory related diseases. The Chinese patent application 201911422748.X reports the application of polypeptide as an active ingredient and auxiliary materials or auxiliary components, including carboxypropyl methylcellulose, asiaticoside, sodium hyaluronate and allantoin, as a composition in anti-inflammatory and antipruritic effects, wherein the composition has the effects of anti-inflammatory, and inhibiting and relieving pruritus symptoms. Because the purification steps of the peptide are complex, the process is multiple, the preparation cost of the peptide is higher, the single polypeptide has single function, is easily limited by factors such as enzymolysis, poor permeability and the like, and is difficult to meet the treatment requirement of the complex skin problem.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provide a polypeptide composition which has good effects of preparing and treating skin allergy, skin itch and common skin inflammation related diseases.

In one aspect, the invention provides a polypeptide composition with anti-allergic, antipruritic, anti-inflammatory and repairing functions, and in particular relates to a polypeptide composition which comprises a composite peptide consisting of acetyl dipeptide-1, palmitoyl tripeptide-8, hexapeptide-9, tetrapeptide-3, palmitoyl tripeptide-5, dipeptide-15 and acetyl heptapeptide-4 and auxiliary materials.

Preferably, the polypeptide composition comprises 0.2-0.8% of acetyl dipeptide-1, 0.02-0.07% of palmitoyl tripeptide-8, 0.02-0.1% of hexapeptide-9, 0.08-0.15% of tetrapeptide-3, 0.05-0.2% of palmitoyl tripeptide-5, 0.05-0.2% of dipeptide-15, 0.02-0.1% of acetyl heptapeptide-4 and the balance of auxiliary materials.

Preferably, the polypeptide composition further comprises herba Portulacae extract, dipotassium glycyrrhizinate, ceramide NP, liposome and purified water.

Preferably, the content percentage of purslane extract, dipotassium glycyrrhizinate, ceramide NP and liposome in the polypeptide composition is 0.5-2% of purslane extract, 0.1-0.3% of dipotassium glycyrrhizinate, 1-3% of ceramide NP and 0.5-2% of liposome, and the balance is purified water.

Preferably, the liposome in the combination is phosphatidylcholine and cholesterol, and the mass ratio is 3:1.

Preferably, the polypeptide composition employs liposomes to encapsulate the polypeptide.

In a preferred embodiment, the present invention provides a method for preparing the above composite carrier-encapsulated polypeptide, which comprises the steps of:

Step 1, dissolving rechecking peptide into phosphate buffer with pH of 6.8 according to prescription amount to prepare solution with polypeptide concentration of 10 mg/mL, adding herba Portulacae extract, dipotassium glycyrrhizinate and ceramide NP, and stirring uniformly;

step 2, preparing liposome by adopting a film dispersion method;

And 3, adding the polypeptide-containing solution in the step 1 into the liposome, stirring, coating, and freeze-drying to obtain the polypeptide-containing composition.

In a second aspect, the invention provides any pharmaceutically acceptable external preparation prepared by combining the composition with pharmaceutically acceptable auxiliary materials.

Preferably, the external preparation is one of gel, cream, emulsion, face cream, ointment, paste, lotion, patch, application, film coating agent, cataplasm, aerosol or spray.

In a third aspect, the invention also provides a polypeptide composition emulsion for treating skin inflammatory related diseases with anti-allergic, antipruritic, anti-inflammatory and repairing functions, wherein the emulsion comprises a polypeptide composition and pharmaceutically acceptable emulsion auxiliary materials.

Preferably, the emulsion auxiliary material comprises squalane, glycerol and a pH regulator.

In a preferred embodiment, the present invention provides an anti-allergic antipruritic, anti-inflammatory and repairing functional polypeptide composition emulsion, the composition content of which is shown in the following table 1:

table 1 emulsion formulations containing 10-20% polypeptide composition

The pH regulator is preferably citric acid or triethanolamine;

In a preferred embodiment, the present invention provides a method for preparing an emulsion of the above polypeptide composition, comprising:

Step 1, dissolving a composite polypeptide liposome in PBS (pH 6.8) to prepare a solution with the concentration of 5 mg/mL, adding purified water and glycerol, and uniformly stirring to prepare a solution A;

Step 2, slowly dripping squalane and capric triglyceride into the solution A in a high-speed shearing machine to form colostrum;

And 3, transferring the colostrum into a high-pressure homogenizer, homogenizing under high pressure, filtering and sterilizing by a microporous filter membrane, and filling into a sterile container to obtain emulsion of the polypeptide composition.

It is explained that most of skin itch is caused by skin inflammation, so that synergistic effect of relieving itching and eliminating inflammation is needed for skin itch, and polypeptide is used as natural product for diminishing inflammation and inhibiting bacteria, and has no side effect, and the polypeptide can improve skin inflammation through three-in-one action mechanism of immunity regulation, nerve signal blocking, barrier strengthening and other multidimensional problems. Compared with single component, the multi-target characteristic of the composition is safer and more efficient, has strong transdermal absorbability, and is suitable for being developed into external preparations (such as emulsion and essence) for treating skin diseases and daily care.

The invention has the beneficial effects that:

Compared with the prior art, the application overcomes the defects of single polypeptide of single function, is easily limited by factors such as enzymolysis, poor permeability and the like, has synergistic polypeptide, improves the itching relieving treatment effect through the combined actions of anti-inflammatory, repairing and antibacterial multiple targets, breaks through polypeptide permeation bottleneck by nano delivery technology, realizes high-efficiency delivery and slow release, combines natural components, reduces stimulation risk and enhances barrier repairing function.

Detailed Description

The invention is further illustrated by the following examples. The test methods used in the examples described below are conventional methods unless otherwise specified, and the materials, reagents, etc., used are commercially available reagents and materials unless otherwise specified.

Example 1 a polypeptide composition was prepared according to the following recipe:

table 2 example 1 composition recipe (100 g)

The specific preparation process is as follows:

Step 1, dissolving rechecking peptide into phosphate buffer with pH of 6.8 according to prescription amount to prepare solution with polypeptide concentration of 10g/mL, adding pure purslane extract, dipotassium glycyrrhizinate and ceramide NP, and stirring uniformly;

Step 2, liposome is dissolved in 60mL of ethyl acetate/methanol mixed solvent (3:1, v/v) to prepare a lipid solution with the concentration of 20 mg/mL, and the lipid solution is placed in a rotary evaporator and evaporated under reduced pressure at 40 ℃ and minus 0.08 MPa to form a uniform lipid film.

And 3, adding the PBS solution containing the polypeptide prepared in the step 1, adding purified water, stirring for 30 min in a water bath at 40 ℃ to completely hydrate the lipid membrane, transferring to an ultrasonic crusher, and performing ultrasonic treatment under ice bath conditions (power 300W, work 5 s/interval 5s and total time 10 min) to form a liposome suspension.

Step 4, passing the liposome suspension through a polycarbonate membrane extruder (extrusion pressure is 0.8 MPa, and the circulation times are 5 times) with a pore diameter of 100 nm, and freeze-drying to obtain the liposome with uniform particle diameter.

Example 2 a polypeptide composition was prepared according to the following recipe:

Table 3 example 2 composition recipe (100 g)

The specific preparation process is as follows:

Step 1, dissolving rechecking peptide into phosphate buffer with pH of 6.8 according to prescription amount to prepare solution with polypeptide concentration of 10 mg/mL, adding herba Portulacae extract, dipotassium glycyrrhizinate and ceramide NP, and stirring uniformly;

Step 2, liposome is dissolved in 25mL of ethyl acetate/methanol mixed solvent (3:1, v/v) to prepare a lipid solution with the concentration of 20 mg/mL, and the lipid solution is placed in a rotary evaporator and evaporated under reduced pressure at 40 ℃ and minus 0.08 MPa to form a uniform lipid film.

And 3, adding the PBS solution containing the polypeptide prepared in the step 1, adding purified water, stirring for 30 min in a water bath at 40 ℃ to completely hydrate the lipid membrane, transferring to an ultrasonic crusher, and performing ultrasonic treatment under ice bath conditions (power 300W, work 5 s/interval 5s and total time 10 min) to form a liposome suspension.

Step 4, passing the liposome suspension through a polycarbonate membrane extruder (extrusion pressure is 0.8 MPa, and the circulation times are 5 times) with a pore diameter of 100 nm, and freeze-drying to obtain the liposome with uniform particle diameter.

Example 3 a polypeptide composition was prepared according to the following recipe:

Table 4 example 3 composition recipe (100 g)

The specific preparation process is as follows:

Step 1, dissolving rechecking peptide into phosphate buffer with pH of 6.8 according to prescription amount to prepare solution with polypeptide concentration of 10 mg/mL, adding herba Portulacae extract, dipotassium glycyrrhizinate and ceramide NP, and stirring uniformly;

step 2, liposome is dissolved in 100mL of ethyl acetate/methanol mixed solvent (3:1, v/v) to prepare a lipid solution with the concentration of 20 mg/mL, and the lipid solution is placed in a rotary evaporator and evaporated under reduced pressure at 40 ℃ and minus 0.08 MPa to form a uniform lipid film.

And 3, adding the PBS solution containing the polypeptide prepared in the step 1, adding purified water, stirring for 30 min in a water bath at 40 ℃ to completely hydrate the lipid membrane, transferring to an ultrasonic crusher, and performing ultrasonic treatment under ice bath conditions (power 300W, work 5 s/interval 5s and total time 10 min) to form a liposome suspension.

Step 4, passing the liposome suspension through a polycarbonate membrane extruder (extrusion pressure is 0.8 MPa, and the circulation times are 5 times) with a pore diameter of 100 nm, and freeze-drying to obtain the liposome with uniform particle diameter.

Example 4a polypeptide composition was prepared according to the following recipe:

Table 5 example 4 composition recipe (100 g)

The specific preparation process is as follows:

Step 1, dissolving rechecking peptide into phosphate buffer with pH of 6.8 according to prescription amount to prepare solution with polypeptide concentration of 10 mg/mL, adding herba Portulacae extract, dipotassium glycyrrhizinate and ceramide NP, and stirring uniformly;

Step 2, liposome is dissolved in 20mL of ethyl acetate/methanol mixed solvent (3:1, v/v) to prepare lipid solution with the concentration of 20 mg/mL, and the lipid solution is placed in a rotary evaporator and evaporated under reduced pressure at 40 ℃ and minus 0.08 MPa to form a uniform lipid film.

And 3, adding the PBS solution containing the polypeptide prepared in the step 1, adding purified water, stirring for 30 min in a water bath at 40 ℃ to completely hydrate the lipid membrane, transferring to an ultrasonic crusher, and performing ultrasonic treatment under ice bath conditions (power 300W, work 5 s/interval 5s and total time 10 min) to form a liposome suspension.

Step 4, passing the liposome suspension through a polycarbonate membrane extruder (extrusion pressure is 0.8 MPa, and the circulation times are 5 times) with a pore diameter of 100 nm, and freeze-drying to obtain the liposome with uniform particle diameter.

Example 5 a polypeptide composition was prepared according to the following recipe:

Table 6 example 5 composition recipe (100 g)

The specific preparation process is as follows:

Step 1, dissolving rechecking peptide into phosphate buffer with pH of 6.8 according to prescription amount to prepare solution with polypeptide concentration of 10 mg/mL, adding herba Portulacae extract, dipotassium glycyrrhizinate and ceramide NP, and stirring uniformly;

Step 2, liposome is dissolved in 200mL of ethyl acetate/methanol mixed solvent (3:1, v/v) to prepare a lipid solution with the concentration of 20 mg/mL, and the lipid solution is placed in a rotary evaporator and evaporated under reduced pressure at 40 ℃ and minus 0.08 MPa to form a uniform lipid film.

And 3, adding the PBS solution containing the polypeptide prepared in the step 1, adding purified water, stirring for 30 min in a water bath at 40 ℃ to completely hydrate the lipid membrane, transferring to an ultrasonic crusher, and performing ultrasonic treatment under ice bath conditions (power 300W, work 5 s/interval 5s and total time 10 min) to form a liposome suspension.

Step 4, passing the liposome suspension through a polycarbonate membrane extruder (extrusion pressure is 0.8 MPa, and the circulation times are 5 times) with a pore diameter of 100 nm, and freeze-drying to obtain the liposome with uniform particle diameter.

Comparative example 1 a polypeptide composition was prepared according to the following recipe:

Table 7 comparative example 1 recipe (100 g)

The specific preparation process is as follows:

Step 1, dissolving rechecking peptide into phosphate buffer with pH of 6.8 according to prescription amount to prepare solution with polypeptide concentration of 10 mg/mL, adding herba Portulacae extract, dipotassium glycyrrhizinate and ceramide NP, and stirring uniformly;

Step 2, liposome is dissolved in 60mL of ethyl acetate/methanol mixed solvent (3:1, v/v) to prepare a lipid solution with the concentration of 20 mg/mL, and the lipid solution is placed in a rotary evaporator and evaporated under reduced pressure at 40 ℃ and minus 0.08 MPa to form a uniform lipid film.

And 3, adding the PBS solution containing the polypeptide prepared in the step 1, adding purified water, stirring for 30 min in a water bath at 40 ℃ to completely hydrate the lipid membrane, transferring to an ultrasonic crusher, and performing ultrasonic treatment under ice bath conditions (power 300W, work 5 s/interval 5s and total time 10 min) to form a liposome suspension.

Step 4, passing the liposome suspension through a polycarbonate membrane extruder (extrusion pressure is 0.8 MPa, and the circulation times are 5 times) with a pore diameter of 100 nm, and freeze-drying to obtain the liposome with uniform particle diameter.

Comparative example 2, table 8 comparative example 2 composition recipe

The specific preparation process is as follows:

Step 1, dissolving rechecking peptide into phosphate buffer with pH of 6.8 according to prescription amount to prepare solution with polypeptide concentration of 10 mg/mL, adding herba Portulacae extract, dipotassium glycyrrhizinate and ceramide NP, and stirring uniformly;

Step 2, liposome is dissolved in 60mL of ethyl acetate/methanol mixed solvent (3:1, v/v) to prepare a lipid solution with the concentration of 20 mg/mL, and the lipid solution is placed in a rotary evaporator and evaporated under reduced pressure at 40 ℃ and minus 0.08 MPa to form a uniform lipid film.

And 3, adding the PBS solution containing the polypeptide prepared in the step 1, adding purified water, stirring for 30 min in a water bath at 40 ℃ to completely hydrate the lipid membrane, transferring to an ultrasonic crusher, and performing ultrasonic treatment under ice bath conditions (power 300W, work 5 s/interval 5s and total time 10 min) to form a liposome suspension.

Step 4, passing the liposome suspension through a polycarbonate membrane extruder (extrusion pressure is 0.8 MPa, and the circulation times are 5 times) with a pore diameter of 100 nm, and freeze-drying to obtain the liposome with uniform particle diameter.

Comparative example 3, table 9 comparative example 3 composition recipe

The specific preparation process is as follows:

Step 1, dissolving rechecking peptide into phosphate buffer with pH of 6.8 according to prescription amount to prepare solution with polypeptide concentration of 10 mg/mL, adding herba Portulacae extract, dipotassium glycyrrhizinate and ceramide NP, and stirring uniformly;

Step 2, liposome is dissolved in 60mL of ethyl acetate/methanol mixed solvent (3:1, v/v) to prepare a lipid solution with the concentration of 20 mg/mL, and the lipid solution is placed in a rotary evaporator and evaporated under reduced pressure at 40 ℃ and minus 0.08 MPa to form a uniform lipid film.

And 3, adding the PBS solution containing the polypeptide prepared in the step 1, adding purified water, stirring for 30 min in a water bath at 40 ℃ to completely hydrate the lipid membrane, transferring to an ultrasonic crusher, and performing ultrasonic treatment under ice bath conditions (power 300W, work 5 s/interval 5s and total time 10 min) to form a liposome suspension.

Step 4, passing the liposome suspension through a polycarbonate membrane extruder (extrusion pressure is 0.8 MPa, and the circulation times are 5 times) with a pore diameter of 100 nm, and freeze-drying to obtain the liposome with uniform particle diameter.

Comparative example 4, table 11 composition recipe for comparative example 4

The specific preparation process is as follows:

Step 1, dissolving rechecking peptide into phosphate buffer with pH of 6.8 according to prescription amount to prepare solution with polypeptide concentration of 10 mg/mL, adding herba Portulacae extract, dipotassium glycyrrhizinate and ceramide NP, and stirring uniformly;

Step 2, liposome is dissolved in 60mL of ethyl acetate/methanol mixed solvent (3:1, v/v) to prepare a lipid solution with the concentration of 20 mg/mL, and the lipid solution is placed in a rotary evaporator and evaporated under reduced pressure at 40 ℃ and minus 0.08 MPa to form a uniform lipid film.

And 3, adding the PBS solution containing the polypeptide prepared in the step 1, adding purified water, stirring for 30 min in a water bath at 40 ℃ to completely hydrate the lipid membrane, transferring to an ultrasonic crusher, and performing ultrasonic treatment under ice bath conditions (power 300W, work 5 s/interval 5s and total time 10 min) to form a liposome suspension.

Step 4, passing the liposome suspension through a polycarbonate membrane extruder (extrusion pressure is 0.8 MPa, and the circulation times are 5 times) with a pore diameter of 100 nm, and freeze-drying to obtain the liposome with uniform particle diameter.

Comparative example 5, table 12 comparative example 5 composition recipe

The specific preparation process is as follows:

Step 1, dissolving rechecking peptide into phosphate buffer with pH of 6.8 according to prescription amount to prepare solution with polypeptide concentration of 10 mg/mL, adding herba Portulacae extract, dipotassium glycyrrhizinate and ceramide NP, and stirring uniformly;

step 2, adding hyaluronic acid into 60mL of ethyl acetate/methanol mixed solvent (3:1, v/v) to prepare a solution with the concentration of 20mg/mL, placing the solution into a rotary evaporator, and evaporating under reduced pressure at 40 ℃ and minus 0.08 MPa to form a transparent film;

Step 3, adding the PBS solution containing the polypeptide prepared in the step 1, adding purified water, stirring for 30min in a water bath at 40 ℃ to completely hydrate the transparent film, transferring the transparent film into an ultrasonic crusher, and performing ultrasonic treatment under ice bath conditions (power 300W, work 5 s/interval 5 s, total time 10 min) to form a suspension;

Step 4, passing the suspension through a polycarbonate membrane extruder (extrusion pressure is 0.8 MPa, and the circulation times are 5 times) with a pore diameter of 100 nm, and freeze-drying to obtain the wrapping material with uniform particle diameter.

Verification example:

1. The stability test method comprises the steps of placing the cream for three months at 45+/-2 ℃ to observe the appearance, color and smell, the cold resistance test comprises the steps of placing the cream for three months at-18+/-2 ℃ to observe the appearance, color and smell, and the cold and heat resistance test comprises the steps of storing the cream for 24 hours at 45 ℃, normal temperature and-18 ℃ respectively, and circulating the cream for 3 times to observe the appearance, color and smell of the cream. The test results are shown in Table 15.

TABLE 13 stability test results

As can be seen from Table 13, the polypeptide compositions of examples 1 to 5 of the present invention have excellent stability, and the properties are maintained at high temperature, low temperature and high and low temperature cycles, wherein the purslane extract, dipotassium glycyrrhizinate, ceramide NP and liposome are mutually promoted in stability, and have unexpected synergistic effects.

2. Antipruritic effect test, the polypeptide-containing composition prepared in the example was further prepared into an emulsion according to the following formulation

Table 14 emulsion formulations containing polypeptide compositions

Preparation method

Step 1, dissolving a composite polypeptide liposome in PBS (pH 6.8) to prepare a solution with the concentration of 5 mg/mL, adding glycerol, and uniformly stirring to prepare a solution A;

Step 2, slowly dripping squalane and capric triglyceride into the solution A in a high-speed shearing machine to form colostrum;

And 3, transferring the colostrum into a high-pressure homogenizer, homogenizing under high pressure, filtering and sterilizing by a microporous filter membrane, and filling into a sterile container to obtain emulsion of the polypeptide composition.

The specific experiment:

220C 57BL/6 mice, weight 20+ -2 g, male and female half, were divided into 11 groups randomly and were respectively a model control group, a positive control group (dermatitis ointment), an example 1-5 emulsion group, and a comparative example 1-5 emulsion group.

The skin of the right back instep of the mouse is ground by fine sand paper, 0.1mL of 0.02% histamine phosphate is extracted and dropped on the ground skin in the degree that the skin is red and oozes without bleeding, and the number and duration of the spasticity and itch of the mouse within 15min are immediately observed and recorded. The spasticity and itching are indicated by that the mice lick back and gnaw the skin of the back of the right foot, and the itching duration time interval is more than 3 seconds and is recorded as two itching, and the itching is recorded as one itching less than 3 seconds. Immediately after molding, the medicated soap was dipped in water and then uniformly applied to the skin of the right back instep of the mouse and gently applied for a moment, and the number of times (total times) and duration (total duration) of itching of the mouse within 15min were recorded and the results are shown in table 15.

Table 15 antipruritic effect on itching due to histamine phosphate

The results show that the emulsion has obvious antipruritic effect when being smeared on the skin of a mice with an itch model, the effect is better than that of a positive medicine (dermatitis ointment) control group, the antipruritic effect is definite, the acetyl dipeptide-1 can be seen to have good antipruritic effect through comparative examples 1-5, and the purslane extract, dipotassium glycyrrhizinate, ceramide NP and liposome have synergistic effects.

3. For skin inflammation treatment test, the material preparation comprises dehairing 40 SD rats 1 day before animal molding, using dehairing paste to dehairing the back, wherein the area is 3cm×3cm, coating 50L5%2, 4-Dinitrochlorobenzene (DNCB) on the dehairing area 1 st sensitization experiment 1 day after dehairing, and coating 100L1% DNCB on the outside of the dehairing area 2 nd sensitization experiment 8 days after dehairing. 3 weeks after, 100L1% DNCB was sensitized 1 time per week for 4 weeks. 3 days after the last sensitization, the molding is finished, and the skin surface of the rat shows symptoms such as keratinization, flaky erythema, crusting, prolongation of epidermis process, thickening of the acantha layer, slight spongy edema and the like, which indicates that the molding is successful.

The experimental procedure was that 30 SD rats successfully modeled were randomly divided into a model group (physiological saline), a positive control group (0.1% hydrocortisone butyrate cream, dose: 1.0 g/kg) and an experimental group (prepared according to the prescriptions of example 1 and Table 14, dose: 80 g/ear) according to a digital random table method, and 10 rats each were transdermally administered for 5 weeks.

Efficacy assessment symptom scoring the degree of skin lichenification, erythema and papules in rats was analyzed and the severity of the symptomatic grading was scored.

Mossiness, no mossiness at 0, small amount of fine scales at 1, obvious fine scales at 2, and large amount of scales at 3.

The red spots are 0 minutes without red spots, 1 minute with invisible reddish spots, 2 minutes with obvious pale red spots, and 3 minutes with a large number of dark red spots.

Pimple 0 is no pimple, 1 pimple is scattered, 2 pimples are fused and dense, and 3 pimples are fused obviously and dense.

Table 16 treatment effect score

Note that the lower the score, the better the effect

The results show that the novel polypeptide composition designed by the invention can directly kill pathogenic bacteria, reduce and alleviate inflammatory reaction, and can be used for treating skin inflammation.

The examples of the present invention are presented herein for purposes of illustration only and not for purposes of limitation, and therefore, simple modifications of the invention that fall within the scope of the invention as hereinafter claimed are intended to be included in the subject invention.

Claims (10)

1. A polypeptide composition for anti-allergy, antipruritic, and treatment of inflammatory skin diseases, characterized in that the polypeptide composition comprises the following components: a complex peptide consisting of acetyl dipeptide-1, palmitoyl tripeptide-8, hexapeptide-9, tetrapeptide-3, palmitoyl tripeptide-5, dipeptide-15, and acetyl heptapeptide-4, and excipients. 2. The polypeptide composition according to claim 1, characterized in that the polypeptide composition comprises the following components in weight percentage: 0.2-0.8% acetyl dipeptide-1, 0.02%~0.07% palmitoyl tripeptide-8, 0.02%~0.1% hexapeptide-9, 0.08%~0.15% tetrapeptide-3, 0.05%~0.2% palmitoyl tripeptide-5, 0.05%~0.2% dipeptide-15, 0.02%~0.1% acetyl heptapeptide-4, with the remainder being excipients. 3. The polypeptide composition according to claim 1, characterized in that the polypeptide composition further comprises purslane extract, dipotassium glycyrrhizate, ceramide NP, liposomes, and purified water. 4. The polypeptide composition according to claim 3, characterized in that the percentage content of purslane extract, dipotassium glycyrrhizate, ceramide NP, and liposomes is 0.5-2% purslane extract, 0.1-0.3% dipotassium glycyrrhizate, 1-3% ceramide NP, 0.5-2% liposomes, and the remainder is purified water. 5. The polypeptide composition according to claim 3, characterized in that the liposomes in the composition are phosphatidylcholine and cholesterol, with a mass ratio of phosphatidylcholine to cholesterol of 3:1. 6. The polypeptide composition according to claim 3, characterized in that the polypeptide composition employs liposomes to encapsulate the polypeptide. 7. A method for preparing a polypeptide composition according to claims 1-6 for relieving allergies and itching, and for treating inflammatory skin diseases, characterized in that the preparation method comprises the following steps: Step 1: Dissolve the complex peptide in phosphate buffer at pH 6.8 according to the prescription amount to prepare a solution with a peptide concentration of 10 mg/mL. Add purslane extract, dipotassium glycyrrhizate, and ceramide NP and stir well. Step 2: Prepare liposomes using the thin-film dispersion method; Step 3: Add the polypeptide-containing solution from Step 1 to the liposomes, stir to coat, freeze dry, and obtain the polypeptide-containing composition. 8. Use of a polypeptide composition comprising the anti-allergic, antipruritic, and skin inflammation-related diseases as described in claims 1-6 in the preparation of a medicament or cosmetic having anti-allergic, antipruritic, and other skin-related functions. 9. The use according to claim 8, wherein the polypeptide combination can be formulated into an emulsion for treating skin problems, the emulsion comprising the polypeptide composition and pharmaceutically acceptable emulsion excipients. 10. The use according to claim 8, wherein the emulsion excipients comprise squalane, glycerin, and a pH adjuster.