CN116803403A - A Chinese medicinal composition for adjuvant treatment of psoriasis, compound external preparation, and its preparation method - Google Patents
A Chinese medicinal composition for adjuvant treatment of psoriasis, compound external preparation, and its preparation method Download PDFInfo
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- CN116803403A CN116803403A CN202310676965.1A CN202310676965A CN116803403A CN 116803403 A CN116803403 A CN 116803403A CN 202310676965 A CN202310676965 A CN 202310676965A CN 116803403 A CN116803403 A CN 116803403A
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Abstract
The invention discloses a medicament for assisting in treating psoriasis, a compound external preparation and a preparation method thereof, wherein the active ingredients of the medicament comprise rhubarb extract powder, corktree bark and coptis root co-extract powder, compound extract liquid prepared from baical skullcap root extract powder and urea, wherein the weight ratio of the total amount of the rhubarb extract powder, corktree bark and coptis root co-extract powder and baical skullcap root extract powder to the urea is 1:15-36. The technical scheme provided by the medicine for assisting in treating psoriasis, the compound external preparation and the preparation method thereof have the effects of relieving itching, improving skin injury and skin inflammation, and can meet the daily skin care requirements of patients with psoriasis vulgaris and the effect of assisting in treating psoriasis during the onset of psoriasis.
Description
The invention claims priority of Chinese patent application filed by the China patent office at 12 months and 20 days of 2022 with application number 2022116436496 and application name of 'a compound external preparation for assisting in treating psoriasis and a preparation method thereof', and the whole content of the compound external preparation is incorporated by reference.
Technical Field
The invention belongs to the technical field of skin care preparations, and in particular relates to a medicament for assisting in treating psoriasis, a compound external preparation and a preparation method thereof.
Background
Psoriasis is a common chronic inflammatory skin disease, which is commonly seen as psoriasis vulgaris. The cause of psoriasis is not clear at present, and clinically, red pimples, plaques, scales and pruritus are mostly shown, and symptoms are more frequent on the scalp, limbs and trunk. The skin of psoriasis vulgaris suffers from barrier dysfunction, which results in low moisture content of skin horny layer, manifests as dry skin, desquamation, usually accompanied by dry feel, itching feel or burning pain, and is susceptible to redness, skin sensitivity or allergy symptoms. The external medicine for symptomatic treatment of psoriasis is mainly one or a plurality of emollients, vitamin D3 derivatives, tretinoin, glucocorticoids and the like. Wherein, the external medicines such as vitamin D3 derivatives, tretinoin, glucocorticoid and the like are limited by adverse reactions of medicines and are not suitable for long-term use by psoriasis patients. In addition, while emollients are suitable for long term use and benefit from psoriasis patients, emollients have limited ability to relieve skin discomfort. Therefore, the development of a non-pharmaceutical product which is suitable for long-term use by psoriasis patients and has the effects of moisturizing skin and relieving psoriasis symptoms is the problem to be solved at present.
Further investigation has found that in French patent FR2868952A1, a moisturizing lotion suitable for caring and recovering lipid from cutin of skin with flaking tendency realizes strong and long-acting moisturizing effect by using high concentration of natural moisturizing factor-urea. The formula patent can relieve skin discomfort caused by low moisture content of skin horny layer, but lacks the effects of improving sensitive symptoms, inflammation symptoms and skin barrier of psoriasis skin.
Further investigation shows that the traditional Chinese medicine preparation "Sihuang", namely the fine powder of the traditional Chinese medicines of baical skullcap root, amur corktree bark, golden thread and rhubarb, can be externally used for treating inflammatory skin diseases, and can be prepared into oral liquid by combining other traditional Chinese medicine raw materials to have high curative effect on psoriasis (CN 1060375C). "Sihuang" is mainly used for curing skin inflammation, and has no obvious moisturizing and moisturizing effect.
Disclosure of Invention
The invention aims to provide a compound external preparation for adjuvant therapy of psoriasis, which has the effects of strong moisturizing, anti-inflammatory and antipruritic, pi Fufan red relieving and desquamation, and is suitable for adjuvant therapy of psoriasis for a long time.
The technical scheme for achieving the aim comprises the following steps.
The invention provides a medicine for assisting in treating psoriasis, which comprises active ingredients of rheum officinale extract powder, phellodendron bark and coptis chinensis co-extract powder, a compound extract prepared from scutellaria baicalensis extract powder and urea, wherein the weight ratio of the total amount of the rheum officinale extract powder, the phellodendron bark and coptis chinensis co-extract powder and the scutellaria baicalensis extract powder to the urea is 1:15-36.
In some embodiments, the rhubarb extract powder, the phellodendron bark and the coptis root co-extract powder and the scutellaria root extract powder are used in the same amount.
In some embodiments, the weight ratio of the total amount of the rheum officinale extract powder, the phellodendron bark and coptis chinensis co-extract powder and the scutellaria baicalensis extract powder to the urea is 1:15-34, and more preferably 1:15-20.
In some embodiments, the rhubarb extract powder, the phellodendron bark and coptis root co-extract powder and the scutellaria root extract powder are prepared by water extraction or alcohol extraction.
In some embodiments, the alcohol extraction method of the rheum officinale extract powder, the phellodendron bark and coptis chinensis co-extract powder and the scutellaria baicalensis extract powder comprises the following steps: respectively soaking rhubarb and equal amount of phellodendron bark, coptis chinensis and baical skullcap root in 45-55% ethanol with the weight portions of 7-9 times, carrying out reflux extraction to obtain concentrated extract, standing to obtain precipitate, and drying the precipitate to obtain rhubarb extract powder, phellodendron bark and coptis chinensis co-extract powder and baical skullcap root extract powder.
In some embodiments, the extraction process of the corktree bark and coptis chinensis co-extracted powder and the baical skullcap root extracted powder comprises the steps of reflux extraction to obtain concentrated extract, adding an acid agent into the extract, settling to obtain a precipitate, washing the precipitate with water until the pH value of the water washing solution is 3.5-4.5, taking the washed precipitate, and drying the precipitate to obtain corktree bark and coptis chinensis co-extracted powder and baical skullcap root extracted powder.
The second aspect of the invention provides a compound external preparation for assisting in treating psoriasis, which comprises the following components in parts by weight as 100 parts:
8-25 parts of complexing agent
75-92 parts of formulation auxiliary agents;
wherein the complexing agent comprises a component A, a component B and a component C:
the component A comprises the following components: the medicament as claimed in any one of claims 1 to 5, wherein the medicament accounts for 3 to 99 percent of the total amount of the complexing agent, and the weight ratio of the total amount of the rheum officinale extract powder, the phellodendron bark and coptis chinensis co-extract powder and the scutellaria baicalensis extract powder to the dipotassium glycyrrhizinate is 1:10 to 15;
the component B comprises the following components: sweet almond oil and bergamot essential oil;
the component C comprises the following components: sodium hyaluronate, glycerol, butylene glycol;
the formulation auxiliary agent comprises an emulsifying agent, a thickening agent, an antioxidant and water.
In some embodiments, the drug comprises 3% to 20% of the total amount of the complexing agent, preferably 3% to 10% of the total amount of the complexing agent, and more preferably 3% to 10% of the total amount of the complexing agent.
In some of these embodiments, the B component comprises the following components in parts by weight:
sweet almond oil 2-20 parts
0.1-1 part of bergamot essential oil; and/or the number of the groups of groups,
the component C comprises the following components in parts by weight:
sodium hyaluronate 0.01-0.5 parts
2-12 parts of glycerol
1-8 parts of butanediol; and/or the number of the groups of groups,
the formulation auxiliary agent comprises the following components in parts by weight:
2-5 parts of emulsifying agent
0.01-0.8 part of thickener
0.1-0.5 part of antioxidant.
In some of these embodiments, the a-component further comprises allantoin; preferably, the allantoin is 0.1-1 parts by weight;
and/or, the component B also comprises shea butter; preferably, the shea butter is 2-5 parts by weight;
and/or, the C component further comprises polyglycerol; preferably, the polyglycerol is 1-2 parts by weight.
In some of these embodiments, the emulsifier is a combination of two or more of methyl glucoside half-stearate, PEG-20 methyl glucoside half-stearate, glycerol stearate/PEG-100 stearate;
and/or, the thickener is carbomer;
and/or the antioxidant is any one of butylated hydroxyanisole and butylated hydroxytoluene;
and/or, the dosage form auxiliary agent further comprises a chelating agent, a preservative, a buffering agent and a pH value regulator;
and/or the pH value of the compound external preparation is 5.5-7.
The third aspect of the invention provides a preparation method of a compound external preparation for adjuvant therapy of psoriasis based on the above, which comprises the following steps:
the preparation method of the matrix comprises the following steps: the preparation method comprises the steps of separating other components except rheum officinale extract powder, phellodendron bark and coptis chinensis co-extract powder, scutellaria baicalensis extract powder, dipotassium glycyrrhizinate, urea and bergamot essential oil into two groups according to water solubility and oil solubility, respectively dissolving/swelling, heating to 70-80 ℃ to respectively obtain oil-soluble components and water-soluble components, mixing, stirring and homogenizing to obtain a matrix;
discharging: cooling the substrate to 45-55 ℃, adding rhubarb extract powder, phellodendron bark and coptis root extract powder, baical skullcap root extract powder, dipotassium glycyrrhizinate, urea and bergamot essential oil, regulating the pH value of the product to 5.5-7, stirring, homogenizing, vacuumizing and discharging.
The fourth aspect of the invention also provides application of the compound external preparation in preparing a preparation for assisting in treating psoriasis.
According to the invention, the compound extract prepared from rhubarb extract powder, phellodendron bark and coptis root extract powder and baical skullcap root extract powder is used together with urea, wherein the total amount of the rhubarb extract powder, the phellodendron bark and the coptis root extract powder and the baical skullcap root extract powder and the urea are used in a specific proportion to form a synergistic effect, so that excellent anti-inflammatory and skin barrier dysfunction relieving effects can be provided, and the compound external preparation formed by matching with other compositions such as sweet almond oil, bergamot essential oil, sodium hyaluronate, glycerol, butanediol, formulation auxiliary agents and the like can provide excellent moisturizing, anti-inflammatory and itching relieving effects, can effectively relieve the symptoms such as dryness, desquamation, redness, itching and the like caused by skin barrier dysfunction, has the effects of relieving itching, improving skin injury and skin inflammation, and can meet the daily skin care requirements of patients suffering from psoriasis vulgaris and the auxiliary treatment effect during the psoriasis attack.
When the weight ratio of the use amount of the rhubarb extract powder, the phellodendron bark and coptis root co-extract powder and the baical skullcap root extract powder to the urea is 1:15-20, compared with the anti-inflammatory effect of the four-yellow fine powder compound urea prepared from rhubarb, phellodendron bark and coptis root, the synergistic effect of the compound extract and urea is obviously superior to the effect of the four-yellow fine powder and urea compound.
Drawings
Fig. 1 is a graph of skin lesions of each group of psoriasis model mice of experimental example 1 on different days.
Fig. 2 is a view of the pathological sections of mice in the blank group, model group, example 1 and comparative example 2 of experimental example 1.
FIG. 3 is a graph showing the effect of the fine four-yellow powder and the compound extract on the migration quantity of neutrophils in zebra fish embryos according to experimental example 2, wherein p is less than 0.001;
fig. 4 is a graph showing the effect of urea and tetrafine powder or complex extract on the migration amount of neutrophils in zebra fish embryos according to experimental example 3, wherein p < 0.01 and p < 0.001.
Detailed Description
The experimental procedures, which do not address the specific conditions in the examples below, are generally carried out under conventional conditions or under conditions recommended by the manufacturer. The various chemicals commonly used in the examples are commercially available.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.
The following describes the invention in more detail.
Example 1
The compound external preparation for assisting in treating psoriasis is prepared into emulsifiable paste, and comprises the following raw material components in parts by weight:
component 1. Radix Scutellariae extract powder 0.01 weight parts, cortex Phellodendri and rhizoma Coptidis extract powder 0.01 weight parts, and radix et rhizoma Rhei extract powder 0.01 weight parts; the disodium hydrogen phosphate buffer solution is prepared from 30 parts by weight of sodium dihydrogen phosphate and disodium hydrogen phosphate as well as purified water.
Wherein, the preparation method of the rheum officinale extract powder comprises the following steps:
soaking medicinal parts of radix et rhizoma Rhei in 8 times of 50% ethanol, reflux-extracting at 75deg.C for two times, extracting for 120 min each time, and mixing extractive solutions;
concentrating the extractive solution to 1/16 volume to obtain concentrated solution, settling in shade, standing for 20 hr to obtain precipitate, and drying the precipitate to obtain radix et rhizoma Rhei extract powder with water content not more than 7 weight parts.
The preparation method of the radix scutellariae extract powder comprises the following steps:
soaking medicinal part of Scutellariae radix in 8 times of 50% ethanol, reflux-extracting at 75deg.C for two times, extracting for 120 min each time, and mixing extractive solutions;
concentrating the extractive solution to 1/16 volume to obtain concentrated solution, adding hydrochloric acid solution into the concentrated solution, stirring and mixing, adjusting pH to 1.5, settling in shade, and standing for 20 hr;
and (3) settling to obtain a precipitate, washing the precipitate with purified water for multiple times until the pH value of the washing liquid is 4.0+/-0.5, taking the washed filter residue, and drying to obtain the radix scutellariae extract powder with the water content of not more than 7 parts by weight.
The preparation method of the phellodendron bark and coptis chinensis co-extract powder (1:1) comprises the following steps:
soaking medicinal parts of cortex Phellodendri and Coptidis rhizoma (1:1) in 8 times of 50% ethanol, reflux-extracting at 75deg.C for two times, extracting for 120 min each time, and mixing extractive solutions;
concentrating the extractive solution to 1/16 volume to obtain concentrated solution, adding hydrochloric acid solution into the concentrated solution, stirring and mixing, adjusting pH to 1.5, settling in shade, and standing for 20 hr;
and (3) settling to obtain a precipitate, washing the precipitate with purified water for multiple times until the pH value of the washing liquid is 4.0+/-0.5, taking the filter residue after washing, and drying to obtain extract powder with the water content of not more than 7 parts by weight.
Component 2 (water-soluble component) purified water 40 parts by weight, sodium hyaluronate 0.05 parts by weight, carbomer 0.6 parts by weight, butanediol 1 part by weight, glycerol 3 parts by weight, EDTA-2Na 0.05 parts by weight.
Component 3 (oil-soluble component). Methyl glucoside half-stearate 1.5 weight parts, PEG-20 methyl glucoside half-stearate 0.6 weight parts, glyceryl stearate/PEG-100 stearate 2 weight parts, shea butter 5 weight parts, sweet almond oil 9 weight parts, butylated hydroxyanisole 0.2 weight parts, phenoxyethanol 0.4 weight parts, and p-hydroxyacetophenone 0.3 weight parts.
Component 4. Urea 1 weight portions, dipotassium glycyrrhizinate 0.3 weight portions.
Component 5. Sodium hydroxide.
Component 6. Bergamot essential oil 0.1 weight portions.
The preparation process of the compound external preparation into the emulsifiable paste comprises the following steps:
firstly, weighing the raw materials of the component 1 according to parts by weight, stably dissolving and dispersing the raw materials in disodium hydrogen phosphate and sodium dihydrogen phosphate buffer solution, heating to 60 ℃, soaking for 0.5 hour, filtering through a 300-mesh sieve, and obtaining a filtrate to obtain a compound extract (namely a compound extract);
respectively weighing the component 2 and the component 3 according to parts by weight, and heating to 80 ℃;
mixing and homogenizing the two component raw materials in the second step for 30s, stirring and dispersing uniformly, and then starting to cool;
and (IV) adding the components 1 and 4 when the temperature is reduced to 50 ℃. Preserving heat and stirring for 30 minutes;
and fifthly, regulating the pH value of the material to 6.3 through the component 5, adding the component 6 and purified water to complement the weight to 100 parts by weight, and stirring and dispersing uniformly to prepare the cream for assisting in treating psoriasis.
Example 2
The compound external preparation for the auxiliary treatment of psoriasis is prepared into emulsion, and comprises the following raw material components in parts by weight:
component 1. Radix Scutellariae extract powder 0.01 weight parts, cortex Phellodendri and rhizoma Coptidis extract powder 0.01 weight parts, and radix et rhizoma Rhei extract powder 0.01 weight parts; the disodium hydrogen phosphate buffer solution is prepared from 30 parts by weight of sodium dihydrogen phosphate and disodium hydrogen phosphate as well as purified water.
Wherein, the preparation modes of rhubarb extract powder, baical skullcap root extract powder, amur corktree bark and golden thread co-extract powder (1:1) are the same as those of the example 1.
Component 2 (water-soluble component) purified water 40 weight parts, sodium hyaluronate 0.05 weight parts, carbomer 0.02 weight parts, butanediol 2 weight parts, glycerol 2 weight parts, EDTA-2Na 0.1 weight parts.
Component 3 (oil-soluble component) 2.5 parts by weight of methyl glucoside hemistearate, 0.95 part by weight of PEG-20 methyl glucoside hemistearate, 4 parts by weight of sweet almond oil, 0.2 part by weight of butylated hydroxyanisole, 0.4 part by weight of phenoxyethanol and 0.3 part by weight of p-hydroxyacetophenone.
Component 4. Urea 0.5 weight portions, dipotassium glycyrrhizinate 0.3 weight portions.
Component 5. Sodium hydroxide.
Component 6. Bergamot essential oil 0.1 weight portions.
The preparation process of the emulsion prepared by the compound external preparation is as follows:
firstly, weighing the raw materials of the component 1 according to parts by weight, stably dissolving and dispersing the raw materials in disodium hydrogen phosphate and sodium dihydrogen phosphate buffer solution, heating to 60 ℃, soaking for 0.5 hour, filtering through a 300-mesh sieve, and obtaining a filtrate to obtain a compound extracting solution;
respectively weighing the component 2 and the component 3 according to parts by weight, and heating to 80 ℃;
mixing and homogenizing the two component raw materials in the second step for 30s, stirring and dispersing uniformly, and then starting to cool;
and (IV) adding the component 1 and the component 4 when the temperature is reduced to 48 ℃. Preserving heat and stirring for 30 minutes;
and fifthly, regulating the pH value of the material body to 6.5 through the component 5, adding the component 6 and purified water to complement the weight to 100 parts by weight, and stirring and dispersing uniformly to prepare the emulsion for assisting in treating psoriasis.
Comparative example 1
The compound external preparation for the auxiliary treatment of psoriasis is prepared into emulsifiable paste, and comprises the following raw material components in parts by weight:
0.15 part by weight of sodium hyaluronate, 47 parts by weight of purified water, 3 parts by weight of beta-cyclodextrin, 0.6 part by weight of PEG-240/HDI copolymer didecyl tetradecyl polyether-20 ether and tridecyl polyether-6 compound raw material, 6 parts by weight of butanediol, 2 parts by weight of hexanediol, 5 parts by weight of purslane extract, 5 parts by weight of radix sophorae flavescentis extract, 5 parts by weight of angelica extract, 0.1 part by weight of medicinal rheum officinale extract, 0.05 part by weight of EDTA-2Na, 0.25 part by weight of allantoin, 4.5 parts by weight of sodium chloride, 1.6 parts by weight of sodium lactate and 0.57 part by weight of lactic acid,
PEG-20 methyl glucose sesquistearate 0.77 weight portions, methyl glucoside sesquistearate 3.23 weight portions, jojoba oil 2 weight portions, shea butter 7 weight portions, sweet almond oil 2 weight portions,
10 parts by weight of urea,
2 parts of propylene glycol, 5 parts of glycerin, 1 part of D-panthenol, 0.6 part of phenoxyethanol and 0.5 part of p-hydroxyacetophenone,
0.19 part by weight of sodium hydroxide,
the purslane extract, the lightyellow sophora root extract and the angelica extract in the compound external preparation are commercially available extract, wherein the purslane extract contains 10 parts by weight of purslane extract, the lightyellow sophora root extract contains 10 parts by weight of lightyellow sophora root extract and the angelica extract contains 10 parts by weight of angelica extract.
The preparation process of the compound external preparation into the emulsifiable paste is referred to in example 1.
Comparative example 2
The compound external preparation for the auxiliary treatment of psoriasis is prepared into emulsion, and comprises the following raw material components in parts by weight:
2.5 parts of methyl glucoside semi-hard butter, 0.95 part of PEG-20 methyl glucoside sesquihard butter, 2 parts of jojoba oil, 2 parts of sweet almond oil, 4 parts of butanediol and 0.7 part of p-hydroxyacetophenone,
68 parts by weight of purified water, 1 part by weight of beta-cyclodextrin, 5 parts by weight of glycerin, 210.01 parts by weight of carbomer U, 0.8 part by weight of phenoxyethanol, 3 parts by weight of purslane extract, 3 parts by weight of radix sophorae flavescentis extract, 3 parts by weight of angelica extract, 0.1 part by weight of EDTA-2Na, 0.01 part by weight of sodium hydroxide, 5 parts by weight of urea, 2.5 parts by weight of sodium chloride, 0.5 part by weight of D-panthenol, 0.002 part by weight of sodium hyaluronate,
0.28 weight part of lactic acid, 0.80 weight part of sodium lactate,
the purslane extract, the lightyellow sophora root extract and the angelica extract in the compound external preparation are commercially available extract, wherein the purslane extract contains 10 parts by weight of purslane extract, the lightyellow sophora root extract contains 10 parts by weight of lightyellow sophora root extract and the angelica extract contains 10 parts by weight of angelica extract.
The preparation process of the compound external preparation into the emulsifiable paste refers to example 2.
Comparative example 3
A moisturizing skin lotion suitable for cutin care and lipid recovery of skin with scale-like tendency of the comparative example comprises the following raw material components: water, urea (10 parts by weight), sodium chloride, glycerin, C12-13 alkyl lactic acid, sodium lactate, stearic acid-2, liquefied paraffin, shea butter, almond oil, stearic acid-21, jojoba seed oil, beeswax, squalane, soyasterol, allantoin, panthenol, amyl acetate, lactic acid, cetyl alcohol, polydimethylsiloxane, phenoxyethanol, xanthan gum, methylparaben, ammonium acryloyldimethyl taurate/VP copolymer, propyl p-benzoate, microcrystalline grain, paraffin, hydroxypropyl starch phosphate, sodium hydroxide, essence.
Comparative example 4
A moisturizing emulsion suitable for skin with a flaking tendency of the comparative example comprises the following raw material components: water, urea (5 parts by weight), glycerin, sorbitol, sodium chloride, sodium citrate, glucolactone, xanthan gum, calcium gluconate, sodium benzoate, and citric acid.
Experimental example 1
1. Animal experiment
1. Experimental animals: BALB/c mice
2. Experimental model: psoriasis model
3. Experiment design: the experimental mice were fed and raised normally for a total of 14 days. A total of 8 mice per group were assigned to 1 control group and 7 model groups. The blank control group was smeared with 12.5mg/cm 2 Vaseline, the model group is smeared with the imiquimod ointment with the same dosage, and the model is molded once a day. Modeling was completed on day 8, and the success of modeling was judged by using PASI (skin lesion area and severity index) scores as criteria, and subsequent experiments were performed on mice that were successfully modeled. And carrying out subsequent experiments by adopting a mode of molding and drug administration simultaneously, wherein the interval between molding and drug administration is at least 8 hours, and the continuous period is 6 days. Animals in the model group were randomly divided into a model control group, an example 1 group, an example 2 group, a comparative example 1 group, a comparative example 2 group, a comparative example 3 group, and a comparative example 4 group at 12.5mg/cm 2 The corresponding formulation was administered, and the blank was given the same dose of petrolatum.
4. Detecting content: the number of times of twisting and back licking of animals was counted within 30 minutes after the administration of the drug on days 3 and 6, and the skin condition of the animals was recorded by photographing, and the PASI (skin area and severity index) score was developed for the skin condition of the skin in the animal test area.
2. Experimental results
1. Antipruritic property test
The number of licking and twisting times of the mice was recorded within 30 minutes after dosing on days 3 and 6, and the data are shown in table 1:
TABLE 1 statistics of the number of licks and wriggles in model mice for psoriasis
Compared with the blank control group, the model group has obviously increased back licking times and waist twisting times (P is less than or equal to 0.05). Compared with the model group: six days after administration, the back licking times and the waist twisting times of the comparative example 3 group, the comparative example 4 group, the example 1 group and the comparative example 2 group are obviously reduced (P is less than or equal to 0.05), the back licking times of the comparative example 1 group and the comparative example 2 group are obviously reduced (P is less than or equal to 0.05), the waist twisting times are not obviously reduced, and the back licking times and the waist twisting times of the example 2 group are not obviously reduced.
When the skin damage of the psoriasis model is within a certain range, the reduction degree of the skin irritation of the test object to the skin damage can be estimated through the observation result of the pruritus test. From the results, the effects of the groups of example 1, comparative example 3 and comparative example 4 on the reduction of skin irritation were relatively remarkable, and the groups of comparative example 1 and comparative example 2 tended to reduce skin irritation.
2. Skin damage repair Performance test
The skin repair performance of the examples and comparative examples was examined by comparison using the PASI (skin area and severity index) scale. The PASI scoring was scored for severity of erythema, infiltration, desquamation of the skin in the test area, respectively, at 0 to 4 scores for asymptomatic, mild, moderate, severe and extremely severe skin lesions. The skin lesions of each group of mice are shown in figure 1 and pasi scores are shown in table 2.
TABLE 2 PASI score statistics of skin lesions in psoriasis model mice
Compared with a blank control group, the PASI score P of the model group is less than or equal to 0.05, and the animal skin of the model group is in the phenomena of erythema, scaling and infiltration, so that the success of the model can be judged.
The scores of the example 1 group and the example 2 group were decreased (P.ltoreq.0.05), the score of the comparative example 3 group was increased, the score of the comparative example 4 group was low, the score of the comparative example 1 group was increased, and the score of the comparative example 2 group had a decreasing tendency, as compared with the model group.
From the scoring results, it is clear that the examples 1 and 2 have a remarkable effect of improving skin damage, and the comparative example 2 group has a tendency of improving skin damage.
3. Pathology of the disease
After the completion of the administration on day 6, the mice were sacrificed, and a blank group, a model group, a group of example 1 having a remarkable improvement effect, and a group of comparative example 2 having a tendency to improve were selected, and the back skin of the mice in the group was fixed in 10 parts by weight of a neutral formalin buffer solution, and pathological section analysis was performed.
5 field images of tissue sections were randomly acquired using an optical microscope, each field image was scored by the Baker method, and the average of the 5 fields was taken as the Baker score for the sample. Fig. 2 is an image of two of the fields of view of a tissue slice in four groups. The Baker score statistics for each group are shown in Table 3.
Table 3 Baker score statistics for pathological sections of psoriasis model mice
The visual field image of fig. 2 shows that the model group has obvious pathological changes such as epidermis acantha thickening, keratinization, munro micro abscess and dermis layer inflammatory cell infiltration compared with the blank group. Similar pathological changes to the model group can be observed for example 1 and comparative example 2. In Baker scores, the average scores of the groups of example 1 and comparative example 2 were lower than the average score of the model group, wherein the group of example 1 had a tendency to improve (p > 0.05), and the group of comparative example 2 had an improving effect (p.ltoreq.0.05).
From the above, the experiments prove that the preparation prepared by the synergistic combination of the composite extract prepared from the rhubarb extract powder, the phellodendron bark and coptis chinensis co-extract powder and the baical skullcap root extract powder and urea has the effects of relieving itching, improving skin injury and skin inflammation, and can meet the daily skin care requirements of patients with psoriasis vulgaris and the effect of auxiliary treatment during the onset of psoriasis.
Experimental example 2
The test components of the experimental example are tetrayellow fine powder and a compound extracting solution, wherein the preparation method of the tetrayellow fine powder comprises the following steps: pulverizing equal amount of radix et rhizoma Rhei, cortex Phellodendri and Coptidis rhizoma (1:1), and sieving with 80 mesh sieve to obtain four-yellow fine powder.
The preparation method of the four-yellow composite extracting solution comprises the following steps: an equal amount of the rhubarb extract powder, the phellodendron bark and coptis root co-extract powder, and the scutellaria root extract powder prepared according to the method of example 1 are dissolved in water to obtain a compound extract.
The testing method specifically comprises the following steps:
(1) Setting a model control group: putting zebra fish embryos fertilized for 72 hours into a 6-hole plate, setting 24 embryos in each hole, setting 1 hole in each group, adding 6mL of copper sulfate solution (the copper sulfate concentration is 1.6 mg/L) into each hole, culturing for 45 minutes, fixing, staining, photographing, observing and counting the migration quantity of neutrophils of the zebra fish embryos;
(2) Positive control group was set: putting zebra fish embryos fertilized for 72 hours into a 6-hole plate, setting 24 embryos in each hole, setting 1 hole in each group, adding 6mL of mixed solution of copper sulfate and dexamethasone (the concentration of the copper sulfate is 1.6mg/L and the concentration of the dexamethasone is 3.96 mg/L) into each hole, culturing for 45 minutes, fixing and dyeing, photographing, observing and counting the migration quantity of neutrophils in the zebra fish embryos;
(3) Setting a sample group to be tested: putting zebra fish embryos fertilized for 72 hours into a 6-hole plate, setting 24 embryos in each hole, setting 1 hole in each group, adding 6mL of copper sulfate and four Huang Xifen (the concentration of the four yellow fine powder in each group is 0.2%, 1% and 5%) or compound extract (the concentration of the four yellow compound extract in each group is 0.2%, 1% and 5%) into each hole, culturing for 45 minutes, fixing, staining, photographing, observing and counting the migration quantity of neutrophils of the zebra fish embryos;
(4) Statistical analysis: taking the zebra fish embryos of the blank control group, the model control group and the sample group to be tested, placing the zebra fish embryos under a forward fluorescence microscope, taking a picture and storing the picture. And counting the number of neutrophils in the muscle tissue part of the tail of the zebra fish embryo.
(5) Results: the number of neutrophil migration in each group of zebra fish was counted 45 minutes after administration, and the data are shown in fig. 3, wherein the four-yellow extract in fig. 3 is the above compound extract. As can be seen from fig. 3, compared with the model control group: after 45 minutes of administration, the migration quantity of neutrophils in the positive control group, the tetrayellow fine powder group and the compound extract group is obviously reduced (P is less than 0.001), and the migration quantity of the tetrayellow fine powder and the compound extract are not obviously different from each other in comparison with the neutrophil.
Experimental example 3
The test components of the experimental example are urea and tetrayellow fine powder or compound extracting solution, wherein the preparation method of the tetrayellow fine powder and the compound extracting solution is consistent with that of experimental example 2.
The weight parts are that the compounding proportion of the urea and the four-yellow fine powder is 5:1, 10:1, 15:1 and 20:1 respectively, and the compounding proportion of the total amount of the urea and the rheum officinale extract powder, the phellodendron bark and coptis chinensis co-extract powder and the scutellaria baicalensis extract powder is 5:1, 10:1, 15:1 and 20:1 respectively.
The method specifically comprises the following steps:
(1) Setting a model control group: putting zebra fish embryos fertilized for 72 hours into a 6-hole plate, setting 24 embryos in each hole, setting 1 hole in each group, adding 6mL of copper sulfate solution into each hole, culturing for 45 minutes, fixing, staining, photographing, observing and counting the migration quantity of neutrophils of the zebra fish embryos;
(2) Positive control group was set: putting zebra fish embryos fertilized for 72 hours into a 6-hole plate, setting 24 embryos in each hole, setting 1 hole in each group, adding 6mL of mixed solution of copper sulfate and dexamethasone (the concentration of the copper sulfate is 1.6mg/L and the concentration of the dexamethasone is 3.96 mg/L) into each hole, culturing for 45 minutes, fixing and dyeing, photographing, observing and counting the migration quantity of neutrophils in the zebra fish embryos;
(3) Setting a sample group to be tested: putting zebra fish embryos fertilized for 72 hours into a 6-hole plate, setting 24 embryos in each hole, setting 1 hole in each group, adding 6mL copper sulfate, urea and four Huang Xifen (the compound proportion is 5:1, 10:1, 15:1 and 20:1 respectively), or compounding mixed solution of urea and compound extract (the compound proportion is 5:1, 10:1, 15:1 and 20:1 respectively, and the compound extract concentration is 0.2%) into each hole, culturing for 45 minutes, fixing, staining, photographing, observing and counting the migration quantity of neutral granulocytes of the zebra fish embryos;
(4) Statistical analysis: taking the zebra fish embryos of the blank control group, the model control group and the sample group to be tested, placing the zebra fish embryos under a forward fluorescence microscope, taking a picture and storing the picture. And counting the number of neutrophils in the muscle tissue part of the tail of the zebra fish embryo.
(5) Results: the number of neutrophil migration in each group of zebra fish was counted 45 minutes after administration, and the data are shown in fig. 4, wherein the four-yellow extract in fig. 4 is the above compound extract. As can be seen from fig. 4, after 45 minutes of administration, the number of neutrophil migration of the positive control group, the urea compound four-yellow fine powder group and the urea compound extracting solution group is obviously reduced (P < 0.001), and when the urea compound ratio is 5:1 and 10:1, the number of neutrophil migration of the compound four-yellow fine powder and the urea compound extracting solution group has no significant difference. In the urea compounding ratio examples 15:1 and 20:1, the migration quantity of neutrophils in the compound four-yellow fine powder and the compound extract is obviously different.
In conclusion, the experiments prove that the four-yellow fine powder and the compound extract have obvious anti-inflammatory effect when being used independently, and no obvious difference exists between the same concentration, so that the biological activity of the compound extract is similar to that of the traditional four-yellow fine powder when being used independently. When the urea and the four-yellow fine powder or the compound extract are compounded and used according to the ratio of 15:1 and 20:1, the urea compound extract has better anti-inflammatory effect than the compound four-yellow fine powder, which shows that the synergistic effect of the compound extract and the urea is obviously better than that of the four-yellow fine powder.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.
Claims (10)
1. The medicine for assisting in treating psoriasis is characterized in that the active ingredients of the medicine comprise rheum officinale extract powder, phellodendron bark and coptis chinensis co-extract powder, a compound extract prepared from scutellaria baicalensis extract powder and urea, wherein the weight ratio of the total amount of the rheum officinale extract powder, the phellodendron bark and coptis chinensis co-extract powder and the scutellaria baicalensis extract powder to the urea is 1:15-36.
2. The medicine according to claim 1, wherein the rhubarb extract powder, the phellodendron bark and coptis root co-extract powder and the scutellaria root extract powder are used in the same amount.
3. The medicament according to claim 1, wherein the weight ratio of the total amount of the rhubarb extract powder, the phellodendron bark and coptis root co-extract powder, the scutellaria root extract powder to the urea is 1:15-34, more preferably 1:15-20.
4. The medicine according to claim 1, wherein the rhubarb extract powder, the phellodendron bark and coptis root extract powder and the scutellaria root extract powder are prepared by water extraction or alcohol extraction.
5. The medicine according to claim 4, wherein the alcohol extraction method of the rhubarb extract powder, the phellodendron bark and coptis chinensis co-extract powder, and the scutellaria extract powder comprises the following steps: respectively soaking rhubarb and equal amount of phellodendron bark, coptis chinensis and baical skullcap root in 45-55% ethanol with the weight portions of 7-9 times, carrying out reflux extraction to obtain concentrated extract, standing to obtain precipitate, and drying the precipitate to obtain rhubarb extract powder, phellodendron bark and coptis chinensis co-extract powder and baical skullcap root extract powder;
preferably, in the extraction process of the corktree bark and coptis chinensis co-extraction powder and the baical skullcap root extraction powder, the method further comprises the steps of adding an acid agent into the extraction solution after reflux extraction to obtain concentrated extraction solution, settling to obtain a precipitate, washing the precipitate with water until the pH value of the water washing solution is 3.5-4.5, obtaining the corktree bark and coptis chinensis co-extraction powder and the baical skullcap root extraction powder after the water washing of the precipitate, and drying the precipitate.
6. The compound external preparation for the auxiliary treatment of psoriasis is characterized by comprising the following components in parts by weight of 100:
8-25 parts of complexing agent
75-92 parts of formulation auxiliary agents;
wherein the complexing agent comprises a component A, a component B and a component C:
the component A comprises the following components: the medicament as claimed in any one of claims 1 to 5, wherein the medicament accounts for 3 to 99 percent of the total amount of the complexing agent, and the weight ratio of the total amount of the rheum officinale extract powder, the phellodendron bark and coptis chinensis co-extract powder and the scutellaria baicalensis extract powder to the dipotassium glycyrrhizinate is 1:10 to 15;
the component B comprises the following components: sweet almond oil and bergamot essential oil;
the component C comprises the following components: sodium hyaluronate, glycerol, butylene glycol;
the formulation auxiliary agent comprises an emulsifying agent, a thickening agent, an antioxidant and water.
7. The compound external preparation according to claim 6, wherein the component B comprises the following components in parts by weight:
the formulation auxiliary agent comprises the following components in parts by weight:
2-5 parts of emulsifying agent
0.01-0.8 part of thickener
0.1-0.5 part of antioxidant.
8. The compound external preparation of claim 6, wherein the a component further comprises allantoin; preferably, the allantoin is 0.1-1 parts by weight;
and/or, the component B also comprises shea butter; preferably, the shea butter is 2-5 parts by weight;
and/or, the C component further comprises polyglycerol; preferably, the polyglycerol is 1-2 parts by weight.
9. The compound external preparation of claim 8, wherein the emulsifier is a combination of two or more of methyl glucoside half-stearate, PEG-20 methyl glucose half-stearate, glycerol stearate/PEG-100 stearate;
and/or, the thickener is carbomer;
and/or the antioxidant is any one of butylated hydroxyanisole and butylated hydroxytoluene;
and/or, the dosage form auxiliary agent further comprises a chelating agent, a preservative, a buffering agent and a pH value regulator;
and/or the pH value of the compound external preparation is 5.5-7.
10. A method for preparing a compound external preparation for the adjuvant therapy of psoriasis based on any one of claims 6 to 9, which is characterized by comprising the following steps:
the preparation method of the matrix comprises the following steps: the preparation method comprises the steps of separating other components except rheum officinale extract powder, phellodendron bark and coptis chinensis co-extract powder, scutellaria baicalensis extract powder, dipotassium glycyrrhizinate, urea and bergamot essential oil into two groups according to water solubility and oil solubility, respectively dissolving/swelling, heating to 70-80 ℃ to respectively obtain oil-soluble components and water-soluble components, mixing, stirring and homogenizing to obtain a matrix;
discharging: cooling the substrate to 45-55 ℃, adding rhubarb extract powder, phellodendron bark and coptis root extract powder, baical skullcap root extract powder, dipotassium glycyrrhizinate, urea and bergamot essential oil, regulating the pH value of the product to 5.5-7, stirring, homogenizing, vacuumizing and discharging.
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1082904A (en) * | 1991-02-28 | 1994-03-02 | 植物药学有限公司 | Treat dermopathic pharmaceutical composition |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1082904A (en) * | 1991-02-28 | 1994-03-02 | 植物药学有限公司 | Treat dermopathic pharmaceutical composition |
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| 乔武；等: "汤原温泉水联合甘草酸二钾抗炎舒敏功效的研究", 《日用化学工业》, vol. 51, no. 5, 22 May 2021 (2021-05-22), pages 2 - 3 * |
| 刘研: "五黄解毒膏临床应用验案", 《湖北中医杂志》, vol. 36, no. 11, 10 November 2014 (2014-11-10), pages 54 * |
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