CN113521152B - Anti-dermatitis composition and preparation method and application thereof - Google Patents
Anti-dermatitis composition and preparation method and application thereof Download PDFInfo
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Abstract
The application provides an anti-dermatitis pharmaceutical composition, which comprises active ingredients prepared from radix rehmanniae recen, radix paeoniae rubra, radix scutellariae, cortex phellodendri, fructus forsythiae, semen plantaginis, phaseolus calcaratus, cortex dictamni and fructus kochiae. The application also provides a preparation method of the pharmaceutical composition and application of the pharmaceutical composition in preparing a medicament or functional food for treating or preventing the inflammatory skin diseases of the individual.
Description
Technical Field
The application belongs to the technical field of biomedicine, and particularly relates to an anti-dermatitis composition, a preparation method thereof and application of the composition in treating or preventing inflammatory skin diseases.
Background
Inflammatory skin diseases refer to skin diseases caused by local inflammation or systemic inflammation, and common examples include Atopic dermatitis (eczema), Psoriasis (Psoriasis), and the like. Atopic dermatitis is a common allergic inflammatory skin disease in clinic, and clinically, skin damage is mainly papules, blisters, exudation, erosion and pruritus, and has the characteristics of severe pruritus, polymorphic damage, repeated attack, lingering, difficult healing and the like. Atopic dermatitis usually originates in infants and has a high prevalence among adults, and about 15 to 30% of the population and 2 to 10% of the population worldwide currently suffer from atopic dermatitis. Psoriasis is an immune-mediated inflammatory skin disease characterized by a large number of silvery-white scales and positive Auspitz signs. Psoriasis is a chronic inflammatory disease common in dermatology, with an incidence rate of 2-3% of the world population. Although the cases of atopic dermatitis and psoriasis are ubiquitous, the etiology is unclear. Atopic dermatitis and psoriasis are currently treated clinically by oral administration of glucocorticoids (dexamethasone) or topical steroid hormones, but their side effects are not negligible, such as causing acneiform skin rash, skin atrophy, telangiectasia, pigmentation, hormone-dependent dermatitis, and the like.
Traditional Chinese herbal medicines are valued by the medical community because of their high safety. However, the effect of the Chinese herbal medicine composition on atopic dermatitis has been studied relatively rarely. It is important to find natural drugs that can regulate immune system functions without toxic and side effects, and it is developed into safe and effective drugs for treating inflammatory skin diseases such as atopic dermatitis and psoriasis or has very important clinical significance.
Disclosure of Invention
In a first aspect, the present application provides an anti-dermatitis pharmaceutical composition, which comprises the following effective ingredients prepared from the following raw materials by weight: 6-50 parts of radix rehmanniae recen, 3-30 parts of radix paeoniae rubra, 3-30 parts of scutellaria baicalensis, 3-30 parts of phellodendron amurense, 3-30 parts of fructus forsythiae, 3-30 parts of semen plantaginis, 3-30 parts of phaseolus calcaratus, 6-40 parts of cortex dictamni and 3-30 parts of fructus kochiae.
In some embodiments, the weight ratio of the raw materials is: 10-25 parts of radix rehmanniae recen, 5-15 parts of radix paeoniae rubra, 5-15 parts of scutellaria baicalensis, 5-15 parts of phellodendron amurense, 5-15 parts of fructus forsythiae, 5-15 parts of semen plantaginis, 5-15 parts of phaseolus calcaratus, 5-20 parts of cortex dictamni and 5-15 parts of fructus kochiae.
In a preferred embodiment, the weight ratio of the raw materials is as follows: 20 parts of radix rehmanniae recen, 10 parts of radix paeoniae rubra, 10 parts of radix scutellariae, 10 parts of cortex phellodendri, 10 parts of fructus forsythiae, 10 parts of semen plantaginis, 10 parts of phaseolus calcaratus, 12 parts of cortex dictamni and 10 parts of fructus kochiae.
In some embodiments, the pharmaceutical composition of the first aspect further comprises a pharmaceutically acceptable excipient. In some embodiments, the excipient is selected from one or a combination of binders, fillers, lubricants, solubilizers, flavoring agents, bacteriostats, antioxidants, and coloring agents.
In some embodiments, the above-mentioned active ingredient contained in the pharmaceutical composition of the first aspect is formulated into a pharmaceutically acceptable dosage form together with a pharmaceutically acceptable excipient. In a preferred embodiment, the dosage form is a tablet, capsule, granule, pill, or oral liquid.
In a second aspect, the present application provides a method of preparing an anti-dermatitis pharmaceutical composition comprising:
(1) weighing the following raw material medicines in parts by weight: 6-50 parts of radix rehmanniae recen, 3-30 parts of radix paeoniae rubra, 3-30 parts of radix scutellariae, 3-30 parts of cortex phellodendri, 3-30 parts of fructus forsythiae, 3-30 parts of semen plantaginis, 3-30 parts of phaseolus calcaratus, 6-40 parts of cortex dictamni and 3-30 parts of fructus kochiae, adding ethanol, soaking for a period of time, extracting and filtering;
(2) recovering the filtrate obtained in step (1), and drying to obtain an extract; and optionally also (c) a second set of one or more of,
(3) adding pharmaceutically acceptable excipient into the extract obtained in step (2), and making into pharmaceutically acceptable dosage forms, such as tablet, capsule, granule, pill or oral liquid.
In a third aspect, the present application provides the use of a pharmaceutical composition according to the first aspect for the manufacture of a medicament for the treatment or prevention of an inflammatory skin disease, or for the repair of the skin barrier.
In some embodiments, the inflammatory skin disease is an allergic inflammatory skin disease. In a preferred embodiment, the inflammatory skin disease is atopic dermatitis. In other embodiments, the inflammatory skin disease is psoriasis.
In some embodiments, the medicament is administered orally or by gavage.
In a fourth aspect, the present application provides a use of the pharmaceutical composition of the first aspect for the preparation of a tablet, capsule, granule, pill or oral liquid for treating or preventing inflammatory skin diseases, or for repairing skin barriers.
In other aspects, the present application provides a method of treating or preventing an inflammatory skin disease by administering to a subject a therapeutically effective amount or a prophylactically effective amount of the pharmaceutical composition of the first aspect.
Drawings
Figure 1. effect of pharmaceutical compositions of the present application on mouse body weight. Each set of data is expressed as mean ± standard error (mean ± SEM), n ═ 12, and compared to the model set, * p<0.05, ** p<0.01。
figure 2. effect of the pharmaceutical composition of the present application on the thickness of the skin on the back of mice. Each set of data is expressed as mean ± standard error (mean ± SEM), n ═ 12, and compared to the model set, * p<0.05, ** p<0.01。
figure 3. effect of the pharmaceutical compositions of the present application on eczematoid symptoms of the dorsal skin of DNCB-treated mice.
Figure 4. effect of the pharmaceutical compositions of the present application on DNCB-treated mice dorsal skin eczematoid symptom score. Each set of data is expressed as mean ± standard error (mean ± SEM), n ═ 12, and compared to the model set, ** p<0.01。
figure 5. effect of the pharmaceutical compositions of the present application on the scratching back behavior score of DNCB-treated mice. Each set of data is expressed as mean ± standard error (mean ± SEM), n ═ 12, and compared to the model set, * p<0.05。
FIG. 6. Effect of the pharmaceutical compositions of the present application on serum IgE (panel A), IL-4 (panel B), histamine (panel C) and TSLP (panel D) levels in DNCB-treated mice. Each set of data is expressed as mean ± standard error (mean ± SEM), n ═ 12, and compared to the model set, * p<0.05, ** p<0.01。
figure 7. effect of the pharmaceutical compositions of the present application on the physiological structure of DNCB-treated mouse skin. The dorsal skin sections of the mice were H & E stained and observed under an optical microscope at 100 x magnification (100 x) with arrows indicating the thickness of the epidermis.
Figure 8. effect of the pharmaceutical compositions of the present application on mast cell infiltration in DNCB treated mouse skin. The skin sections on the backs of the mice were stained with toluidine blue, and mast cells were stained purple red, magnified 200 times (200 x) under an optical microscope, and observed for infiltration of mast cells.
FIG. 9 thickness of DNCB treated mouse skin epidermal layer of pharmaceutical composition of the present application(panel a) and the effect of mast cell number (panel B). Each set of data is expressed as mean ± standard error (mean ± SEM), n ═ 12, and compared to the model set, * p<0.05, ** p<0.01。
FIG. 10. Effect of the pharmaceutical compositions of the present application on IFN-. gamma.levels (panel A), IL-4 (panel B) and IL-6 (panel C) in DNCB treated mouse skin. Each set of data is expressed as mean ± standard error (mean ± SEM), n ═ 12, and compared to the model set, * p<0.05, ** p<0.01。
FIG. 11. Effect of the pharmaceutical compositions of the present application on IL-4 (panel A), IL-13 (panel B), IL-31 (panel C) and IFN-. gamma.mRNA expression in DNCB treated mouse skin. FIG. 11 shows the ratio of IL-4 (panel A), IL-13 (panel B), IL-31 (panel C) and IFN-. gamma.mRNA expression to β -actin mRNA, respectively. Each set of data is expressed as mean ± standard error (mean ± SEM), n ═ 6, and compared to the model set, * p<0.05, ** p<0.01。
FIG. 12. Effect of pharmaceutical compositions of the present application on FLG (panel A) and TSLP (panel B) mRNA expression in DNCB treated mouse skin. Each set of data is expressed as mean ± standard error (mean ± SEM), n ═ 6, and compared to the model set, * p<0.05, ** p<0.01。
figure 13. effect of the pharmaceutical compositions of the present application on FLG, IVL and LOR protein expression in DNCB-treated mouse skin (n ═ 6). Panel A shows the results of a Westernblot assay. Panel B is data obtained by quantifying the expression of each target protein using β -actin as an internal reference, each group of data is expressed as mean ± standard error (mean ± SEM), n ═ 6, compared with the model group, * p<0.05, ** p<0.01。
Detailed Description
The application provides a pharmaceutical composition which comprises active ingredients prepared from raw materials of radix rehmanniae recen, radix paeoniae rubra, radix scutellariae, cortex phellodendri, fructus forsythiae, semen plantaginis, phaseolus calcaratus, cortex dictamni and fructus kochiae. The inventor finds that the pharmaceutical composition can remarkably improve inflammatory skin diseases such as atopic dermatitis-like skin injury after administration and has good treatment effect on the inflammatory skin diseases such as atopic dermatitis through in vivo experiments. In addition, the inventor also finds that the pharmaceutical composition has a good treatment effect on psoriasis.
In some embodiments, the pharmaceutical compositions of the present application further comprise a pharmaceutically acceptable excipient. The "pharmaceutically acceptable excipient" as referred to herein refers to an additive other than the main drug which does not interfere with the biological activity of the active ingredient, and may also be referred to as an auxiliary material, including those conventionally used in the pharmaceutical field, such as a binder, a filler, a disintegrant, a lubricant, a solubilizer, a corrigent, a bacteriostatic agent, an antioxidant, a colorant, a preservative, an emulsifier, an aromatic agent, an osmotic pressure regulator, and the like.
The pharmaceutical compositions of the present application may be presented in unit dosage form and may be prepared by any of the methods well known in the pharmaceutical arts. All methods include the step of bringing into association the active ingredient of the present application with one or more pharmaceutically acceptable excipients. Generally, compositions are prepared by combining the active ingredient with a liquid carrier, a solid carrier, or both, and then shaping the resulting product as desired.
The pharmaceutical composition is a traditional Chinese medicine compound, wherein the monarch drug is rehmannia and red peony.
Dried Rehmannia root is dried root tuber of Rehmannia glutinosa Libosch of Scrophulariaceae, which is the traditional Chinese medicine commonly used in folk China, beginning from Ben Cao Tu Jing. Researches find that the radix rehmanniae can regulate the immunologic function and has various pharmacological effects of resisting inflammation, resisting allergy, reducing temperature, inducing diuresis and the like. Radix Paeoniae Rubra is dried root of Paeonia lactiflora pall or Paeonia veitchii Lynch of Ranunculaceae, and has long application history in Shen nong Ben Cao Jing. Researches show that radix paeoniae rubra contains various chemical components such as terpenes and glycosides thereof, flavonoids and glycosides thereof, volatile oils and the like, and has the effects of resisting inflammation, oxidation and tumors, reducing blood fat, resisting arteriosclerosis, dilating coronary arteries and the like.
The ministerial drugs in the traditional Chinese medicine compound are scutellaria baicalensis, golden cypress and fructus forsythiae. The Scutellariae radix is dried root of Scutellaria baicalensis Georgi of Labiatae. Researches show that the scutellaria has stronger functions of resisting bacteria, diminishing inflammation, resisting virus and resisting allergy, and can improve the immune function of the organism. Cortex Phellodendri is dried bark of Phellodendron chinense Schneid of Rutaceae. The main chemical components of cortex Phellodendri are flavonoids and alkaloids, and have antiallergic, antioxidant and antibacterial effects. Fructus forsythiae is dried fruit of Vahl, Forsythia subspensa (Thunb.) of Oleaceae. Researches find that the forsythia has strong anti-inflammatory effect and also has the effects of resisting oxidation and regulating immune function.
The adjuvant drugs in the traditional Chinese medicine compound of the application are semen plantaginis and phaseolus calcaratus. Plantago asiatica L or Plantago depressa Willd dried mature seeds of Plantago asiatica L. The research shows that the plantain seeds have certain activity in various aspects of diuresis, inflammation diminishing, liver protection, blood sugar reduction, blood pressure reduction, blood fat regulation, oxidation resistance, immunity regulation and the like. The red bean is dried mature seed of Vigna umbellata Ohwi et Ohashi or Vigna angularis Ohwi et Ohashi of leguminosae, and is widely used as a food material for both medicine and food.
The messenger medicine in the traditional Chinese medicine compound is cortex dictamni and fructus kochiae. The cortex Dictamni Radicis is dried root bark of Dictamnus dasycarpus Turcz of Rutaceae. Researches find that the cortex dictamni has good antiallergic and antipruritic effects. The Kochia scoparia is dried mature fruit of Kochia scoparia (L.) Schrad. of Chenopodiaceae. Researches show that the fructus kochiae has different degrees of bacteriostasis on dermatophytes such as yellow ringworm fungus, Odongqixianwu fungus and the like.
The inventor of the application researches the treatment effect of the traditional Chinese medicine compound on atopic dermatitis-like skin injury induced by 2, 4-Dinitrochlorobenzene (DNCB) by establishing a mouse animal model of atopic dermatitis, and analyzes the possible action mechanism of the traditional Chinese medicine compound. Through detecting various indexes in serum and skin of a mouse, the traditional Chinese medicine compound is found to be capable of remarkably improving the specific dermatitis-like skin injury of the mouse, and the action mechanism of the traditional Chinese medicine compound is related to inhibiting inflammatory reaction, regulating immune cell function and further repairing the dermal barrier function.
In some embodiments, the method of preparing a pharmaceutical composition of the present application comprises the steps of:
(1) weighing the following raw material medicines in parts by weight: 10-25 parts of radix rehmanniae recen, 5-15 parts of radix paeoniae rubra, 5-15 parts of scutellaria baicalensis, 5-15 parts of phellodendron amurense, 5-15 parts of fructus forsythiae, 5-15 parts of semen plantaginis, 5-15 parts of phaseolus calcaratus, 5-20 parts of cortex dictamni and 5-15 parts of fructus kochiae, then adding ethanol for soaking for a period of time, carrying out ultrasonic extraction, filtering, and repeating the above extraction steps twice;
(2) mixing the three filtrates obtained in step (1), recovering, and drying to obtain extract; and optionally also (c) a second set of one or more of,
(3) adding pharmaceutically acceptable excipient into the extract obtained in step (2), and making into pharmaceutically acceptable dosage forms, such as tablet, capsule, granule, pill or oral liquid.
In a specific embodiment, the pharmaceutical compositions of the present application are prepared as follows:
(1) weighing the following raw material medicines in parts by weight: 20 parts of radix rehmanniae recen, 10 parts of radix paeoniae rubra, 10 parts of radix scutellariae, 10 parts of cortex phellodendri, 10 parts of fructus forsythiae, 10 parts of semen plantaginis, 10 parts of phaseolus calcaratus, 12 parts of cortex dictamni and 10 parts of fructus kochiae, then adding 60% ethanol, soaking for 24 hours at normal temperature, ultrasonically extracting for 1 hour, filtering, and repeating the extraction steps twice;
(2) mixing the three filtrates obtained in step (1), recovering under reduced pressure, and freeze drying to obtain extract fine powder;
(3) adding pharmaceutically acceptable excipient into the extract obtained in the step (2), and preparing tablets, capsules, granules, pills, oral liquid and the like according to a conventional method.
The pharmaceutical compositions of the present application may be formulated as a medicament for treating or preventing an inflammatory skin disease in an individual, or for repairing a skin barrier.
In some embodiments, examples of inflammatory skin diseases include, but are not limited to, allergic inflammatory skin diseases, such as atopic dermatitis and the like.
As used herein, "treating" includes inhibiting, curing, alleviating or relieving inflammatory skin disorders.
As used herein, a "therapeutically effective amount" or a "prophylactically effective amount" may be determined on a case-by-case basis and can be readily determined by one of ordinary skill in the art based on the amount of drug actually required, e.g., based on the weight, age, and condition of the patient. Since the extracts are non-toxic components, they may be administered directly as an extract, if desired, in which case the composition does not contain pharmaceutically acceptable excipients. When the compositions contain pharmaceutically acceptable excipients, they may be mixed according to methods conventional in the pharmaceutical art to prepare the desired drug.
In certain embodiments, the pharmaceutical compositions of the present application are administered orally, intragastrically, topically, subcutaneously, intramuscularly, or intraperitoneally. In preferred embodiments, the pharmaceutical compositions of the present application are administered orally or by gavage.
"individual," as used herein, refers to mammals, including, but not limited to, primates, cows, horses, pigs, sheep, goats, dogs, cats, and rodents such as rats and mice.
In some embodiments, the pharmaceutical compositions of the present application significantly improve dermatitis-like skin lesions in an individual upon oral administration. In a specific embodiment, the pharmaceutical composition described herein has a good therapeutic effect on DNCB-induced atopic dermatitis-like skin lesions. In other specific embodiments, the pharmaceutical compositions described herein can also significantly ameliorate dermatitis-like skin lesions in individuals with psoriasis.
In some embodiments, the pharmaceutical compositions of the present application are capable of inhibiting allergic reactions, such as reducing the serum levels of immunoglobulin e (ige), histamine, Thymic Stromal Lymphopoietin (TSLP), and Interleukin (IL) -4 in an individual.
In some embodiments, the pharmaceutical compositions of the present application are capable of inhibiting an inflammatory response, such as reducing the levels of inflammatory factors such as IL-4, IL-6, and IFN- γ in the skin.
In some embodiments, the pharmaceutical compositions of the present application inhibit thickening of the epidermal layer of the skin and/or infiltration of inflammatory, mast cells.
In some embodiments, the pharmaceutical composition of the present application is capable of modulating immune function in the body, modulating the level of gene expression of helper T cell-associated factors. For example, in a specific embodiment, the pharmaceutical composition of the present application has a modulating effect on DNCB-induced skin-produced Th1/Th2 imbalance of function, and is capable of up-regulating the level of Th1 cytokines while down-regulating inflammatory factors secreted by over-expressed Th2 cells.
In some embodiments, the pharmaceutical compositions of the present application are capable of repairing skin barriers. In a specific embodiment, the pharmaceutical composition herein can up-regulate the expression levels of Filaggrin (FIG), Involucrin (IVL) and Loricrin (LOR) which are three key protective proteins in the skin, thereby achieving the effect of repairing the skin barrier.
The inventor of the application proves through experiments that the pharmaceutical composition can inhibit inflammatory reaction and anaphylactic reaction by up-regulating FIG, IVL and LOR, thereby obviously improving atopic dermatitis-like skin injury of mice and having a new application of resisting atopic dermatitis.
The present inventors have also found that the pharmaceutical compositions described herein have one or more of the following effects on psoriasis: improving dermatitis-like skin injury, repairing skin barrier, regulating immunity, inhibiting inflammatory reaction, inhibiting anaphylaxis, inhibiting thickening of skin epidermal layer, inhibiting inflammatory cell and mast cell infiltration, and relieving skin pruritus.
In the present description and claims, the words "comprise", "comprises" and "comprising" mean "including but not limited to", and are not intended to exclude other moieties, additives, components or steps.
It should be understood that features, characteristics, components or steps described in a particular aspect, embodiment or example of the present invention may be applied to any other aspect, embodiment or example described herein unless incompatible therewith.
The above disclosure generally describes the present application, which is further exemplified by the following examples. These examples are described merely to illustrate the present application and do not limit the scope of the present application. Although specific terms and values are employed herein, they are to be understood as exemplary and not limiting the scope of the application. Unless otherwise indicated, the experimental methods and techniques described herein are those well known to those skilled in the art.
Examples
The following examples are provided only to illustrate some embodiments of the present application and are not intended to be limiting in any way.
The methods used in the following examples are conventional methods unless otherwise specified. Materials, reagents and the like used in the following examples are commercially available unless otherwise specified.
Example 1: preparation of pharmaceutical compositions of the present application
Mixing radix rehmanniae, radix paeoniae rubra, radix scutellariae, cortex phellodendri, fructus forsythiae, semen plantaginis, phaseolus calcaratus, cortex dictamni and fructus kochiae according to a certain weight ratio (namely, 20 parts by weight of radix rehmanniae, 10 parts by weight of radix paeoniae rubra, 10 parts by weight of radix scutellariae, 10 parts by weight of cortex phellodendri, 10 parts by weight of fructus forsythiae, 10 parts by weight of semen plantaginis, 10 parts by weight of phaseolus calcaratus, 12 parts by weight of cortex dictamni and 10 parts by weight of fructus kochiae, which are equivalent to 20g of radix rehmanniae, 10g of radix paeoniae rubra, 10g of radix scutellariae, 10g of cortex phellodendri, 10g of fructus forsythiae, 10g of semen plantaginis, 10g of phaseolus calcaratus, 12g of cortex dictamni and 10g of fructus kochiae in one dose of medicine), adding 60 percent ethanol of 10 times of the amount to soak for 24 hours, carrying out ultrasonic extraction at 50 ℃ for 1 hour, filtering, and repeating the extraction steps for two times. Mixing the three filtrates, vacuum recovering in rotary evaporator, and freeze drying to obtain fine powder.
Example 2: therapeutic effect of the pharmaceutical composition of the present application on atopic dermatitis
(1) Experimental Material
1.1Laboratory animal and medicine
SPF grade Balb/c mice, female, 22-24g, purchased from the university of Chinese, hong Kong laboratory animal center. The experimental animals are raised in cages, the padding is replaced every 2 days, adaptive feeding is carried out for 7 days, and drinking water and eating are free during the experiment period. The temperature of the breeding environment is 22 +/-2 ℃, the relative humidity is 60%, and the breeding environment is irradiated for 12 hours every day and circulated for 12 hours in the dark.
1.2Preparation of test drug
The extract prepared as in example 1 was prepared with distilled water into test solution samples at concentrations of 0.315, 0.630 and 1.26g extract/ml, respectively.
Positive control test solution (dexamethasone (DXM)): 20mg of dexamethasone is weighed and suspended in 40ml of 0.5 percent sodium carboxymethyl cellulose solution to prepare a positive control solution sample with the concentration of 0.5 mg/ml.
The above medicines are prepared and stored in a refrigerator at 4 ℃ for later use.
1.3Experimental reagent
Molding and dosing reagent:
DNCB, acetone and DXM were purchased from Sigma, usa; distilled water and olive oil were purchased from hong kong drochen corporation; coomassie brilliant blue protein quantitation reagent was purchased from Bio-Rad; kits for assaying mice for IgE, histamine, TSLP, and IL-4, IL-6, and IFN- γ were purchased from Abcam, USA.
Paraffin section preparation and staining related reagents:
eosin, hematoxylin, toluidine blue, xylene, ethanol, hydrochloric acid and neutral gums were purchased from Sigma company, usa.
Westernblot assay related reagents:
RIPA lysate, protease inhibitor cocktail, PMSF (100mM), phosphorylated protease inhibitor, protein loading buffer, SDS-PAGE gel preparation reagent, TRIS buffer, glycine, SDS and Tween-20 from Sigma, USA; PVDF membranes (0.22 μm) were purchased from Bio-Rad; BSA was purchased from Thermo Scientific; beta-actin is available from Santa Cruz; protein Marker, HRP-labeled goat anti-rabbit, and HRP-labeled goat anti-mouse were purchased from Thermo Scientific.
Reagents relevant to PCR assay:
TRIzol reagent was purchased from Thermo Scientific; chloroform and isopropanol were purchased from sigma, usa; the cDNA reverse transcription kit was purchased from Takara; TaqMan rapid amplification PCR kit, TaqMan mouse IL-4, IL-6, IL-13, IL-31, IFN-. gamma., TSLP and Silk polymerization protein (FLG) primers, purchased from applied biosystems.
1.4Laboratory apparatus
752-P UV Spectroscopy Brightness Meter from Shanghai Shigaku Instrument Co., Ltd; the SHIMADZU analytical balance was purchased from guangzhou xiang instrument electromechanical devices, ltd; PL-203 electronic balance was purchased from mettler-tolliduo instruments (shanghai) limited; IKA10 tissue homogenizer was purchased from IKA, Germany; model BH22 light microscope was purchased from Olympus corporation, japan; the FLUO star Optima microplate reader is purchased from BMG Labtec company of Germany; ABI-7500 fluorescent quantitative PCR instrument was purchased from ABI, USA; FBZ2001-up-p Standard reagent type water purifiers were purchased from Fulemm technologies, Inc., Qingdao; a bench top high speed refrigerated centrifuge from Heal force; the DYY-6C electrophoresis apparatus was purchased from six instruments, Beijing.
(2) Animal grouping and administration
Mice were shaved with a razor blade except for the Normal group (Normal Control, NC) for 2cm x 3cm area on the back, and each mouse was applied with 200 μ l of 0.5% DNCB solution (dissolved in acetone: olive oil: 3:1) daily and 20 μ l of each ear for 3 consecutive days. One week later, 200. mu.l of 1% DNCB solution was applied to the back of each mouse, and 20. mu.l of each ear was applied once every 3 days for a total of 7 replicates. The DNCB first application was randomized 14 days into the following six groups: normal group (Normal Control, NC), Model Control group (Model Control, MC), positive Control group (DXM, 5mg/kg), low dose treatment group (SZF-L, 3.15g/kg), medium dose treatment group (SZF-M, 6.30g/kg), and high dose treatment group (SZF-H, 9.45g/kg) of herbal compound extract (i.e., the pharmaceutical composition prepared according to example 1). Each group had 12 mice. After grouping, labeling, the individual mice were weighed again, and the corresponding dosing volumes (10ml/kg) were recorded and calculated. The normal group and the model group were given the same volume of distilled water. The DXM and the compound extract of the traditional Chinese medicine with the concentration are administrated to other groups of mice by gastric lavage once a day for 15 days.
(3) Mouse back eczema symptom scoring and skin thickness testing
The weights of the mice were recorded on the same day (i.e., day 15 of DNCB sensitization), the appearance of the skin on the back was recorded by photographing, the skin was scored according to the EASI scoring rules, and the skin thickness was measured at the midline position on the back of the mice using a vernier caliper. Body weight, back skin appearance and back skin thickness were recorded once a week thereafter ( day 15,22 and 29 for DNCB sensitization). The EASI scoring rules are: according to the severity of four eczema symptoms (erythema, edema, desquamation and lichenification), the four eczema symptoms are respectively graded according to 0-3 points, wherein 0 point represents no symptom, 1 point represents slight, 2 points represents moderate, 3 points represents severe, and finally each mouse is graded as the average of the total scores of the four eczema symptoms.
(4) Mouse scratching behavior experiment
After 1 hour of the last administration, the mice were placed in a transparent observation box, and after the mice were familiar with the environment, the mice were recorded for 20 minutes by a digital camera, and after group information was hidden, the mice were observed by another experimenter, and the time and the number of times that the back of the mice was scratched by the hind legs within 20 minutes were recorded. No scratching was measured at 0 minutes, no scratching was continued for 1.5 seconds at 2 minutes each time, and no scratching was continued for 1.5 seconds at 4 minutes each time.
(5) Blood serum and skin sampling
After the experiment, the mice were bled by orbital bleeding, and the blood samples were allowed to stand at room temperature for 2 hours, followed by centrifugation at 3000rpm for 15min, and the supernatant was separated to obtain serum samples. Mice were sacrificed by cervical molars after blood removal and immediately cut to a size of about 1cm 2 1 part of the back skin tissue is put into 4 percent paraformaldehyde for fixation for 24 hours and is used for making pathological tissue sections; 1 part of the extract is put into cell lysate provided by an ELISA kit for subsequent detection of the ELISA kit; putting 1 part of the extract into a TRIzol reagent for extracting RNA from tissues for subsequent PCR (polymerase chain reaction) determination; 1 aliquot was put into RIPA (containing 1% protein inhibitor) for extraction of total cell protein for subsequent Western Blot assay. After collecting the required tissue, the remaining tissue was stored in a refrigerator at-80 ℃ for use in subsequent experiments.
(6) Western Blot detection of related protein expression
6.1 Total protein extraction
The tissue blocks were washed 2-3 times with cold PBS, decontaminated, cut into small pieces and placed in a homogenizer. 10 tissue volumes of lysis buffer (protease inhibitor added within minutes prior to use) were added and homogenized thoroughly on ice. The homogenate was transferred to a 1.5mL centrifuge tube and shaken. After ice-bath for 30min, repeatedly blowing with a pipette to ensure complete cell lysis, centrifuging at 12,000g for 10min, and collecting supernatant as total protein solution.
6.2 protein concentration determination:
protein concentration was determined using the coomassie brilliant blue method.
6.3SDS-PAGE electrophoresis
SDS-PAGE gels were formulated with reference to the SDS-PAGE gel preparation kit instructions. Adding sufficient electrophoresis liquid, loading for electrophoresis, adding the sample into electrophoresis hole for electrophoresis (concentrated gel voltage 70V, 1 h; separation gel voltage 120V,30min), stopping electrophoresis until bromophenol blue just comes out, and transferring membrane.
6.4 transfer film
6 pieces of 7X 9cm filter paper and a piece of moderately sized PVDF membrane were prepared, which was activated with methanol for 15 seconds before use. The transfer solution-containing pot was filled with a transfer membrane clamp, two sponge pads, filter paper, and activated PVDF membrane. Opening the clamp to keep the black side horizontal, filling sponge and three layers of filter paper on the pad, carefully peeling off the separation gel to cover the filter paper, covering the membrane on the gel, removing air bubbles, covering three pieces of filter paper on the membrane, removing the air bubbles, and finally covering another sponge pad. The film transfer conditions (wet transfer) were: and (5) fast rotating, and rotating the membrane for 45min at a constant current of 250 mA.
6.5 immune response
The transferred membranes were blocked with 5% skim milk (formulated in 0.5% TBST) for 2 hours on a decolorizing shaker at room temperature. Primary antibody (TBST solubilized 5% skim milk, phosphorylated using TBST solubilized 5% BSA) was diluted and incubated overnight at 4 ℃. Then washed three times with TBST on a shaker at room temperature for 5 minutes each, and the secondary antibody was diluted 2000-fold with TBST and incubated for 2 hours at room temperature, and then washed three times with TBST on a shaker at room temperature for 5 minutes each.
6.6 chemiluminescence
Mixing ECLA and ECLB reagents in equal volume in a centrifuge tube, fully contacting the PVDF membrane with the mixed solution with the protein surface facing upwards, removing residual liquid after 1-2 minutes, wrapping, and exposing in a dark box. Finally, developing and fixing are carried out by using a developing and fixing agent, and exposure conditions are adjusted according to different light intensities.
(7) PCR detection of related Gene expression
7.1 extraction of RNA
100mg of skin tissue was added to 1ml of TRIzol reagent, homogenized thoroughly in a homogenizer and incubated on ice for 5min, then 0.2ml of chloroform was added to lyse it, and incubated for 2-3 min. Shaking and mixing, centrifuging for 15min at 12,000 xg with a refrigerated centrifuge, transferring the upper layer water solution to another centrifuge tube, adding 0.5ml isopropanol, mixing, incubating for 10min, centrifuging for 10min at 12,000 xg with a refrigerated centrifuge, and collecting the white precipitate as RNA. Discarding the supernatant, adding 1ml of 75% ethanol, resuspending and mixing uniformly, centrifuging for 5min under the condition of 7,000 xg by using a refrigerated centrifuge, discarding the supernatant, adding 20-50 μ l of DEPC water, heating in a heating plate at 55 ℃ for 10min for inactivation, and finally measuring the RNA content and the purity by using an enzyme-linked immunosorbent assay.
7.2 cDNA reverse transcription
The procedure was performed according to the instructions of the Takara cDNA reverse transcription kit. The RNA loading was 2. mu.g per reaction. The transcribed cDNA is stored in a refrigerator at 80 ℃ below zero for subsequent detection of related genes.
2.7.3 semi-quantitative PCR assay
The operation is carried out according to the instruction of TaqMan rapid amplification PCR kit of applied biosystems company, the transcribed cDNA is combined with primers IL-4, IL-6, IL-13, IL-31, IFN-gamma, TSLP and FLG of TaqMan mice, and beta-actin is an internal reference. The reaction conditions were 50 ℃ for 2min, 95 ℃ for 10min, followed by 40 cycles of amplification (95 ℃ for 15s and 60 ℃ for 1 min). Calculating the amplification multiple of the target gene by adopting a delta CT method, wherein the amplification multiple of the target gene is 2^ 2 -ΔΔCT Wherein Δ Δ CT ═ (CT value- β -actin CT value of gene of interest in experimental group) - (CT value- β -actin CT value of gene of interest in control group).
(8) Histopathological observation
8.1 Paraffin section preparation
Skin tissues are fixed in 4% paraformaldehyde for 24 hours, then are automatically dehydrated in a tissue dehydrator, and then are embedded in paraffin to prepare a wax block, and after being sliced, the paraffin block is dehydrated, transparent and sealed to prepare a paraffin section.
8.2 histopathological observations and determination of the thickness of the dermal layer of the skin
The prepared paraffin sections are dewaxed by dimethylbenzene, then are processed by high-concentration to low-concentration ethanol, and finally are added into distilled water, so that hematoxylin and eosin can be used for dyeing. Dehydrating the dyed slices by ethanol with low concentration to high concentration, and then making the slices transparent by dimethylbenzene. The transparent sections were dropped with gum and mounted with a coverslip. The inflammatory cell infiltration phenomenon in the dermal layer of the skin can be observed and the thickness of the dermal layer of the skin can be measured under an optical microscope.
8.3 measurement of mast cell infiltration by blue staining with toluidine
The prepared paraffin section is dewaxed by dimethylbenzene, then is processed by high-concentration to low-concentration ethanol, and finally is added into distilled water, and then toluidine blue can be used for dyeing. Dehydrating the dyed slices by ethanol with low concentration to high concentration, and then making the slices transparent by dimethylbenzene. The transparent sections were dropped with gum and mounted with a coverslip. Mast cells were observed to stain purple-red in the dermal layer of the skin under a light microscope and the number of mast cells was automatically counted using Image J software.
(9) Determination of inflammatory factor content in skin
The skin tissue was accurately weighed according to the ELISA kit instructions, homogenized using a high speed homogenizer after adding cell lysate, centrifuged at 12,000 xg at 4 ℃ for 15min, and the supernatant was separated to determine the IL-4, IL-6 and IFN-. gamma.content in the skin tissue.
(10) Statistical analysis
Data are expressed as mean ± standard error (mean ± SEM), graphedprism 5 software is used for charting and statistical analysis, differences between groups are compared, One-way analysis of variance (One-WayANOVA) is used, multiple comparisons between groups are performed by Dunnett's method, p <0.05 is used as a standard, and significant differences are expressed. Furthermore, p <0.05, p <0.01 compared to the model group.
(11) Results of the experiment
11.1Effect of the pharmaceutical compositions of the present application on mouse body weight
The study finds that the traditional Chinese medicine compound with low, medium and high doses has no adverse effect on the body weight of a mouse, but the positive control dexamethasone has an obvious inhibition effect on the body weight of the mouse, and the body weight change of each group is shown in figure 1.
11.2Effect of the pharmaceutical compositions of the present application on Back skin thickness of mice
The study finds that the traditional Chinese medicine compound disclosed by the application can obviously inhibit the thickening of the skin on the back of a mouse caused by DNCB (compared with a model group, p is less than 0.01 in a high-dose treatment group), and the inhibition effect is dose-dependent, as shown in figure 2. This result indicates that the pharmaceutical composition of the present application has a significant inhibitory effect on DNCB-induced epidermal thickening.
11.3Effects of the pharmaceutical compositions of the present application on DNCB-induced eczematoid symptoms of the skin on the back of mice
The present study found that the DNCB-induced eczematous symptoms of the skin in the back of mice, such as erythema, edema, desquamation and lichenification of the skin, were significantly improved in the treatment group (as shown in fig. 3). Two weeks after dosing, the EASI scores for the high, medium and low dose treatment groups were <0.01 compared to the model group, with the high dose treatment group having the best treatment effect, comparable to the positive control dexamethasone effect (see figure 4). This result indicates that the pharmaceutical composition of the present application can significantly improve DNCB-induced eczematoid symptoms of the skin.
11.4Effect of the pharmaceutical compositions of the present application on DNCB-induced cutaneous pruritus symptoms on the back of mice
The research finds that the symptoms of skin itch on the back of a mouse induced by DNCB are obviously improved in a high-dose treatment group, the scratching behavior of the mouse is obviously reduced (compared with a model group, p is less than 0.01), and the positive control dexamethasone has a certain inhibiting effect but has a lower effect than a high-dose traditional Chinese medicine compound (as shown in figure 5). The results show that the pharmaceutical composition has obvious antipruritic effect on skin pruritus induced by DNCB.
11.5The pharmaceutical composition of the application has effects on the content of IgE, histamine, TSLP and IL-4 in serum of a mouse subjected to DNCB modeling Sound box
The levels of IgE, histamine, TSLP and IL-4 in serum were measured after DNCB model-making mice were treated with positive control dexamethasone and low, medium and high doses of the herbal combination, respectively. We found that the high dose of the pharmaceutical composition significantly reduced the levels of IgE, TSLP and IL-4 in the serum of DNCB-modelled mice, and there was a tendency for the histamine level to decrease, see fig. 6. This result indicates that the pharmaceutical composition of the present application has significant inhibitory effects on DNCB-induced IgE, TSLP and IL-4, as well as a certain inhibitory effect on histamine release.
11.6Influence of the pharmaceutical composition of the present application on the physiological structure of skin of DNCB-modeled mice
The research shows that the physiological structure of the skin of the DNCB model mouse is obviously changed, such as the thickness of an epidermal layer is obviously thickened, the wave between the epidermal layer and a dermal layer is obviously flattened, inflammatory cells and mast cells in the dermal layer are obviously infiltrated, and the like. However, after the treatment with the pharmaceutical composition of the present application, the above pathological structural changes were significantly improved, the epidermal layer thickness was significantly reduced in the high dose treatment group (p <0.01 compared to the model group), and the inhibitory effect was superior to that of the positive control dexamethasone (as shown in fig. 7 and fig. 9). Furthermore, as shown in fig. 8 and 9, inflammatory cell infiltration was less in the dermal layer of the treated group and mast cell number was significantly reduced compared to the model group (p <0.01 compared to the model group). The above results indicate that the pharmaceutical composition of the present application is effective in ameliorating the change in the physiological structure of mouse skin caused by DNCB, slowing down thickening of the epidermal layer and inhibiting inflammatory reactions in the skin.
11.7The pharmaceutical composition contains inflammatory factors IL-4, IL-6 and IFN-gamma in the skin of a DNCB model mouse Influence of the quantity
The research shows that the content of inflammatory factors IL-4 and IL-6 produced by Th-2 cells in the skin of a mouse is obviously increased after DNCB modeling, and the content of inflammatory factors IFN-gamma produced by Th-1 cells is obviously reduced. After the traditional Chinese medicine compound is used for treating, the content of IL-4 and IL-6 in the skin is obviously reduced, the content of IFN-gamma is correspondingly increased, and the regulation effect of the high-dose treatment group is equivalent to that of the positive control dexamethasone (see figure 10). The results show that the pharmaceutical composition has a regulating effect on the function imbalance of Th1/Th2 induced by DNCB, can down-regulate inflammatory factors secreted by over-expressed Th2 cells, and can up-regulate the level of Th1 cytokines.
11.8Effect of the pharmaceutical composition of the present application on the expression of inflammatory factor mRNA in the skin of DNCB-modeled mice
The research shows that the expression level of mRNA of inflammatory factors IL-4, IL-13 and IL-31 secreted by Th2 cells in the skin of a DNCB model mouse is obviously increased, and the expression level of mRNA of a cytokine IFN-gamma regulated by Th1 cells is correspondingly reduced. After the traditional Chinese medicine compound is used for treating, the mRNA expression levels of IL-4, IL-13 and IL-31 in the skin of a DNCB model mouse are reduced, the mRNA expression level of IFN-gamma is correspondingly increased, wherein the regulation effect of a high-dose treatment group is most obvious and is equivalent to the effect of positive control dexamethasone (see figure 11). The above results indicate that the pharmaceutical composition of the present application can regulate the gene expression level of cytokines secreted by Th1 cells and Th2 cells, thereby correcting the functional imbalance of Th1/Th2 cells induced by DNCB.
11.9Effect of pharmaceutical compositions of the present application on FLG and TSLP mRNA expression in skin of DNCB-modeled mice
The research shows that the expression level of mRNA of a key protein FLG in the skin is obviously reduced in the skin of a DNCB model mouse, and the expression level of mRNA of a downstream protein TSLP is obviously increased. After the treatment of the traditional Chinese medicine compound extract, the mRNA of FLG in the skin of a DNCB model-making mouse is remarkably increased, the mRNA expression level of downstream protein TSLP is remarkably reduced, and the effect of a high-dose treatment group is superior to that of positive control dexamethasone (see fig. 12). The results show that the pharmaceutical composition can improve the mRNA expression level of FLG in the skin of a DNCB model mouse and inhibit the mRNA expression level of TSLP (protein TSLP downstream of the FLG).
11.10Effect of the pharmaceutical compositions of the present application on FLG, IVL, and LOR protein expression in the skin of DNCB-modeled mice
The research finds that the protein expression levels of three key protective proteins FLG, IVL and LOR in the skin are obviously reduced in the skin of a mouse modeled by DNCB, which indicates that the DNCB causes damage to the function of a dermal barrier of the mouse skin. After treatment with the herbal compound of the present application, protein expression levels of FLG, IVL and LOR in the skin of DNCB-modeled mice significantly increased back, and the effect of the high dose treatment group was equivalent to that of the positive control dexamethasone (see fig. 13). The results show that the pharmaceutical composition can improve the protein expression levels of FLG, IVL and LOR in the skin of a DNCB model mouse so as to achieve the effect of repairing the skin barrier.
(12) Discussion of the related Art
Atopic dermatitis not only causes significant damage to skin itching, edema, erythema, desquamation and lichenification, but also has a non-negligible effect on the immune function of the human body, and if it cannot be treated in time, it also develops into a systemic immune disease, posing a threat to the health of the human body, and seriously affecting the quality of life thereof. Because of the serious side effects of the hormone and steroid drugs, the traditional Chinese medicine and natural products are more and more favored by clinical researchers in dermatology. According to the traditional Chinese medicine theory, the atopic dermatitis is caused by the mutual attack of the innate endowment of the body, the internal accumulation of damp-heat, the external infection of wind pathogen and the pathogenic wind-damp-heat and the invasion of the skin. The current pharmacological research on the traditional Chinese medicine for treating atopic dermatitis is mainly focused on the activities of anti-inflammation, anti-allergy and regulating immunity, and the research on the function of repairing skin barrier is little.
We screen the anti-atopic dermatitis effect of various traditional Chinese medicines in preliminary experiments, and the results show that the traditional Chinese medicine compound extract has obvious treatment effect on DNCB-induced atopic dermatitis-like skin injury. The research aims to find the anti-atopic dermatitis medicine with better treatment effect and less side effect, so the traditional Chinese medicine compound of the application is applied to animal experiments to explore the treatment effect of the traditional Chinese medicine compound of the application on atopic dermatitis.
We used DNCB to induce mice to produce an in vivo model of atopic dermatitis-like skin lesions as a validated model to mimic human atopic dermatitis. In our study, it was observed that the skin of mice with DNCB smeared on their backs exhibited typical atopic dermatitis-like lesions including erythema, edema, desquamation, lichenification and the like. Compared with mice in a model group, the skin erythema, edema, desquamation and lichenification symptoms of the mice treated by the traditional Chinese medicine compound extract are obviously improved.
Inflammatory responses and immune disorders are two key factors in the pathogenesis of atopic dermatitis. The helper T cells mainly have the function of secreting cytokines with immune regulation and effector functions, play an important role in immune response, and are mainly divided into two functional subgroups of Th1 and Th 2. The main function of the Th1/Th2 cell is to regulate immune response, the Th1 cell mainly secretes cytokines such as IFN-gamma and IL-2, and the Th2 cell mainly secretes IL-6 and IL-4, and mainly mediates humoral immunity. The Th1/Th2 cellular immune process is mainly through secreting different cytokines, mutual inhibition reaches dynamic balance. In the normal state of the body, Th1/Th2 cells are in dynamic equilibrium, if dynamic equilibrium is broken and the dynamic equilibrium is biased to one, the body will cause disease because Th1 cells are dominant or Th2 cells are dominant to form Th1/Th2 'drift' state. Studies have shown that an imbalance of Th1/Th2 results in atopic dermatitis. Under the stimulation of exogenous factors, the antigen-specific CD4+ T cells are mainly differentiated into Th2 cells, and release a large amount of cytokines such as IL-4 and IL-13 to stimulate B cells to secrete IgE. The combination of IgE and mast cells releases a large amount of histamine to further aggravate anaphylactic reaction, promote lymphokines and macrophage factors to enter skin damage parts, and simultaneously release eosinophilic granulocyte to enter peripheral blood, so that the organism generates systemic anaphylactic reaction. Therefore, measurement of IgE, histamine, and various interleukin factors in serum can be interpreted and used to assess the severity of atopic dermatitis. Our studies show that the anti-atopic dermatitis effect of the traditional Chinese medicine compound of the application is closely related to anti-inflammation, anti-allergy, reduction of IgE, histamine and IL-4 level in serum and inhibition of Th2 cell factor and gene expression level thereof in skin tissues. The results of the studies of the inventors clearly indicate that the pharmaceutical composition of the present application can exert its anti-atopic dermatitis effect by inhibiting inflammatory reactions and regulating immune functions.
Impaired dermal barrier of the skin is also an important factor in the pathogenesis of atopic dermatitis. The loss of filaggrin, involucrin and loricrin can cause damage to the dermal barrier, accelerate the loss of moisture from the skin and produce dry skin and desquamation. The pharmaceutical composition can improve the gene expression level of the filaggrin, and inhibit the gene expression level of downstream TSLP to increase the protein expression level of the filaggrin, involucrin and loricrin in the skin, thereby achieving the effect of restoring the dermal barrier function. The above results suggest that restoration of the dermal barrier function of the skin is an important biological action mechanism of the pharmaceutical composition of the present application against atopic dermatitis.
In summary, the pharmaceutical composition of the present application has an excellent effect of treating atopic dermatitis, which is associated with the inhibition of inflammation, the regulation of immunity and/or the protection of skin barrier function.
Example 3: preparation of pharmaceutical composition tablets of the present application
1000g of the compound traditional Chinese medicine extract prepared in the example 1 is taken, 480g of lactose and 500g of starch are added and mixed uniformly, 300g of 7% starch slurry is used as a bonding agent for wet granulation, drying is carried out, 20g of magnesium stearate is added and mixed uniformly, and 10000 tablets containing 100mg of the extract in each tablet are pressed, and the net weight of each tablet is 0.2 g. It is administered orally 2 times daily, 3 tablets each time, for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of skin.
Example 4: preparation of pharmaceutical composition tablets of the present application
Taking 800g of the extract prepared in the example 1, adding 480g of lactose and 700g of starch, uniformly mixing, using 300g of 7% starch slurry as a binding agent, carrying out wet granulation, drying, adding 20g of magnesium stearate, uniformly mixing, and pressing into 10000 tablets containing 80mg of the extract per tablet, wherein the net weight of each tablet is 0.2 g. It is administered orally 2 times daily, 3 tablets each time, for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 5: preparation of pharmaceutical composition tablets of the present application
Taking 500g of the extract prepared in the example 1, adding 480g of lactose and 1000g of starch, uniformly mixing, using 300g of 7% starch slurry as a binding agent, carrying out wet granulation, drying, adding 20g of magnesium stearate, uniformly mixing, and pressing into 10000 tablets containing 50mg of the extract per tablet, wherein the net weight of each tablet is 0.2 g. It is administered orally 2 times daily, 3 tablets each time, for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 6: preparation of pharmaceutical composition tablets of the present application
1000g of the extract prepared in example 1 is taken, 2984g of starch is added and mixed uniformly, 350g of 7% starch slurry is used as a binding agent, wet granulation is carried out, drying is carried out, 16g of magnesium stearate is added and mixed uniformly, 10000 tablets containing 100mg of the extract in each tablet are pressed, and the net weight of each tablet is 0.4 g. It is administered orally 2 times daily, 3 tablets each time, for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 7: preparation of pharmaceutical composition tablets of the present application
800g of the extract prepared in the example 1 is taken, 3184g of starch is added and mixed evenly, 350g of 7% starch slurry is used as a binding agent, wet granulation is carried out, drying is carried out, 16g of magnesium stearate is added and mixed evenly, 10000 tablets containing 80mg of the extract in each tablet are pressed, and the net weight of each tablet is 0.4 g. It is administered orally 2 times daily, 3 tablets each time, for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 8: preparation of pharmaceutical composition tablets of the present application
500g of the extract prepared in the example 1 is taken, 3484g of starch is added and mixed evenly, 350g of 7% starch slurry is used as a binding agent, wet granulation is carried out, drying is carried out, 16g of magnesium stearate is added and mixed evenly, and 10000 tablets containing 50mg of the extract are pressed into each tablet, and the net weight of each tablet is 0.4 g. It is administered orally 2 times per day, 3 tablets each time, for resisting atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 9: preparation of pharmaceutical composition tablets of the present application
1000g of the extract prepared in the example 1 is taken, 594g of lactose and 390g of starch are added and mixed uniformly, 350g of 7% starch slurry is used as a binding agent, wet granulation is carried out, drying is carried out, 16g of magnesium stearate is added and mixed uniformly, 10000 tablets containing 100mg of the extract in each tablet are pressed, and the net weight of each tablet is 0.2 g. It is administered orally 2 times per day, 3 tablets each time, for resisting atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 10: preparation of pharmaceutical composition tablets of the present application
800g of the extract prepared in the example 1 is taken, 614g of lactose is added and mixed evenly, 570g of starch is mixed evenly, 350g of 7% starch slurry is used as a binding agent, wet granulation is carried out, drying is carried out, 16g of magnesium stearate is added and mixed evenly, and 10000 tablets containing 80mg of the extract in each tablet are pressed into tablets, and the net weight of each tablet is 0.2 g. It is administered orally 2 times daily, 3 tablets each time, for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 11: preparation of pharmaceutical composition tablets of the present application
500g of the extract prepared in the example 1 is taken, 574g of lactose is added and mixed evenly, 350g of 7% starch slurry is used as a binding agent, wet granulation is carried out, drying is carried out, 16g of magnesium stearate is added and mixed evenly, and 10000 tablets containing 50mg of the extract in each tablet are pressed, and the net weight of each tablet is 0.2 g. It is administered orally 2 times daily, 3 tablets each time, for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 12: preparation of pharmaceutical composition tablets of the present application
1000g of the extract prepared in example 1 is taken, 480g of dextrin and 1114g of starch are added and mixed uniformly, 350g of 7% starch slurry is used as a binding agent, wet granulation is carried out, drying is carried out, 16g of magnesium stearate is added and mixed uniformly, 10000 tablets containing 100mg of the extract in each tablet are pressed, and the net weight of each tablet is 0.1 g. It is administered orally 2 times daily, 3 tablets each time, for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 13: preparation of pharmaceutical composition tablets of the present application
Taking 800g of the extract prepared in the example 1, adding 480g of dextrin and 1134g of starch, uniformly mixing, using 350g of 7% starch slurry as a binding agent, carrying out wet granulation, drying, adding 16g of magnesium stearate, uniformly mixing, and pressing into 10000 tablets containing 80mg of the extract per tablet, wherein the net weight of each tablet is 0.2 g. It is administered orally 2 times daily, 3 tablets each time, for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 14: preparation of pharmaceutical composition tablets of the present application
500g of the extract prepared in the example 1 is taken, 480g of dextrin and 1094g of starch are added and mixed uniformly, 350g of 7% starch slurry is used as a binding agent, wet granulation is carried out, drying is carried out, 16g of magnesium stearate is added and mixed uniformly, and 10000 tablets containing 50mg of the extract in each tablet are pressed, and the net weight of each tablet is 0.2 g. It is administered orally 2 times daily, 3 tablets each time, for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 15: preparation of pharmaceutical composition tablets of the present application
1000g of the extract prepared in example 1 is taken, 480g of lactose and 1114g of starch are added and mixed uniformly, 350g of 7% starch slurry is used as a bonding agent for wet granulation and drying, 16g of talcum powder is added and mixed uniformly, and 10000 tablets containing 100mg of the extract per tablet are pressed, and the net weight of each tablet is 0.2 g. It is administered orally 2 times daily, 3 tablets each time, for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 16: preparation of pharmaceutical composition tablets of the present application
Taking 800g of the extract prepared in the example 1, adding 480g of lactose and 1134g of starch, uniformly mixing, using 350g of 7% starch slurry as a binding agent, carrying out wet granulation, drying, adding 16g of talcum powder, uniformly mixing, and pressing into 10000 tablets containing 80mg of the extract per tablet, wherein the net weight of each tablet is 0.2 g. It is administered orally 2 times daily, 3 tablets each time, for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 17: preparation of pharmaceutical composition tablets of the present application
500g of the extract prepared in the example 1 is taken, 480g of lactose and 1094g of starch are added and mixed evenly, 350g of 7% starch slurry is used as a binding agent, wet granulation is carried out, drying is carried out, 16g of talcum powder is added and mixed evenly, and 10000 tablets containing 50mg of the extract in each tablet are pressed into tablets, and the net weight of each tablet is 0.2 g. It is administered orally 2 times daily, 3 tablets each time, for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 18: preparation of pharmaceutical composition tablets of the present application
1000g of the extract prepared in the example 1 is taken, 480g of dextrin and 504g of starch are added and mixed uniformly, 350g of 7% starch slurry is used as an adhesive, wet granulation is carried out, drying is carried out, 16g of talcum powder is added and mixed uniformly, and 10000 tablets containing 100mg of the extract are pressed into each tablet, and the net weight of each tablet is 0.2 g. It is administered orally 2 times per day, 3 tablets each time, for resisting atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 19: preparation of pharmaceutical composition tablets of the present application
Taking 800g of the extract prepared in the example 1, adding 480g of dextrin and 704g of starch, uniformly mixing, using 350g of 7% starch slurry as a binding agent, performing wet granulation, drying, adding 16g of talcum powder, uniformly mixing, and pressing into 10000 tablets containing 80mg of the extract per tablet, wherein the net weight of each tablet is 0.2 g. It is administered orally 2 times daily, 3 tablets each time, for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 20: preparation of pharmaceutical composition tablets of the present application
500g of the extract prepared in the example 1 is taken, 480g of dextrin and 1004g of starch are added and mixed uniformly, 350g of 7% starch slurry is used as a bonding agent, wet granulation is carried out, drying is carried out, 16g of talcum powder is added and mixed uniformly, and 10000 tablets containing 50mg of the extract in each tablet are pressed, and the net weight of each tablet is 0.2 g. It is administered orally 2 times daily, 3 tablets each time, for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 21: preparation of pharmaceutical composition capsules of the present application
1000g of the extract prepared in example 1 was taken, 980g of lactose and 1004g of starch were added, mixed uniformly, 350g of 7% starch slurry was used as a binder, wet granulation was performed, drying was performed, 16g of magnesium stearate was added, mixed uniformly, and filled into capsules No. 1 (capsules No. 1: 16.60 in body length (tolerance. + -. 0.50), 9.80 in cap length (tolerance. + -. 0.50), 0.110 in body thickness (tolerance. + -. 0.50), 0.110 in cap thickness (tolerance. + -. 0.50), 6.63 in body outer diameter (tolerance. + -. 0.50), 6.91 in cap outer diameter (tolerance. + -. 0.50), and 0.50ml in capsule volume were made into 10000 capsules, each capsule contained 100mg of the extract, and each capsule weighed 0.3 g. It is administered orally 2 times daily, 3 granules each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 22: preparation of pharmaceutical composition capsules of the present application
800g of the extract prepared in the example 1 is taken, 980g of lactose and 1204g of starch are added and mixed uniformly, 350g of 7% starch slurry is used as a binding agent, wet granulation and drying are carried out, 16g of magnesium stearate is added and mixed uniformly, and the mixture is filled into No. 1 capsules to be 10000 capsules, wherein each capsule contains 80mg of the extract, and the net weight of each tablet is 0.3 g. It is administered orally, 2 times daily, 3 granules each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 23: preparation of pharmaceutical composition capsules of the present application
500g of the extract prepared in the example 1 is taken, 980g of lactose and 1504g of starch are added and mixed uniformly, 350g of 7% starch slurry is used as a binding agent, wet granulation and drying are carried out, 16g of magnesium stearate is added and mixed uniformly, and the mixture is filled into No. 1 capsules to be prepared into 10000 capsules, wherein each capsule contains 50mg of the extract, and the net weight of each tablet is 0.3 g. It is administered orally 2 times daily, 3 granules each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 24: preparation of pharmaceutical composition capsules of the present application
1000g of the extract prepared in the example 1 is taken, 2984g of starch is added and mixed uniformly, 350g of 7% starch slurry is used as a binding agent, wet granulation is carried out, drying is carried out, 16g of magnesium stearate is added and mixed uniformly, and the mixture is filled into No. 1 capsules to be 10000 capsules, wherein the net weight of each capsule is 0.4g, and each capsule contains 100mg of the extract. It is administered orally 2 times daily, 3 granules each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 25: preparation of pharmaceutical composition capsules of the present application
Taking 800g of the extract prepared in the example 1, adding 3184g of starch, uniformly mixing, using 350g of 7% starch slurry as a binding agent, carrying out wet granulation, drying, adding 16g of magnesium stearate, uniformly mixing, filling into No. 1 capsules, preparing into 10000 capsules, wherein each capsule is 0.4g in net weight and contains 80mg of the extract. It is administered orally 2 times daily, 3 granules each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 26: preparation of pharmaceutical composition capsules of the present application
500g of the extract prepared in the example 1 is taken, 3484g of starch is added and mixed uniformly, 350g of 7% starch slurry is used as a binding agent, wet granulation is carried out, drying is carried out, 16g of magnesium stearate is added and mixed uniformly, and the mixture is filled into No. 1 capsules to be prepared into 100000 capsules, wherein each capsule contains 50mg of the extract, and the net weight of each capsule is 0.4 g. It is administered orally 2 times daily, 3 granules each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 27: preparation of pharmaceutical composition capsules of the present application
1000g of the extract prepared in example 1 was taken, 1480g of lactose and 2504g of starch were added and mixed uniformly, 350g of 7% starch slurry was used as a binder, wet granulation was performed, drying was performed, 16g of magnesium stearate was added and mixed uniformly, and No. 0 capsule (No. 0 capsule: 18.60 in body length (tolerance ± 0.50), 11.00 in cap length (tolerance ± 0.50), 0.115 in body thickness (tolerance ± 0.50), 0.115 in cap thickness (tolerance ± 0.50), 7.33 in body outside diameter (tolerance ± 0.50), 7.64 in cap outside diameter (tolerance ± 0.50), and 0.68ml in capsule volume was prepared into 10000 capsules, each capsule contained 100mg of the extract and 0.5g of net weight per capsule. It is administered orally 2 times daily, 3 granules each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 28: preparation of pharmaceutical composition capsules of the present application
Taking 800g of the extract prepared in the example 1, adding 1480g of lactose and 2704g of starch, mixing uniformly, using 350g of 7% starch slurry as a binding agent, granulating by a wet method, drying, adding 16g of magnesium stearate, mixing uniformly, filling into No. 0 capsules, and preparing into 10000 capsules, wherein each capsule contains 80mg of the extract, and the net weight of each capsule is 0.5 g. It is administered orally 2 times daily, 3 granules each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of skin.
Example 29: preparation of pharmaceutical composition capsules of the present application
Taking 600g of the extract prepared in the example 1, adding 1480g of lactose and 2904g of starch, uniformly mixing, using 350g of 7% starch slurry as a binding agent, carrying out wet granulation, drying, adding 16g of magnesium stearate, uniformly mixing, filling into No. 0 capsules, and preparing into 10000 capsules, wherein each capsule contains 50mg of the extract, and the net weight of each capsule is 0.5 g. It is administered orally 2 times daily, 3 granules each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 30: preparation of pharmaceutical composition capsules of the present application
500g of the extract prepared in example 1 was taken, 1480g of lactose and 3004g of starch were added and mixed uniformly, 350g of 7% starch slurry was used as a binder, wet granulation was performed, drying was performed, 16g of magnesium stearate was added and mixed uniformly, and No. 2 capsules (No. 2 capsule: 15.40 in body length (tolerance ± 0.50), 9.00 in cap length (tolerance ± 0.50), 0.105 in body thickness (tolerance ± 0.50), 0.105 in cap thickness (tolerance ± 0.50), 6.07 in body outside diameter (tolerance ± 0.50), 6.35 in cap outside diameter (tolerance ± 0.50), and 0.37ml in capsule volume were prepared into 10000 capsules, each capsule contained 50mg of the extract and 0.2g of net weight per capsule. It is administered orally 2 times daily, 3 granules each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 31: preparation of pharmaceutical composition capsules of the present application
400g of the extract prepared in the example 1 is taken, 480g of lactose and 1104g of starch are added and mixed uniformly, 350g of 7% starch slurry is used as a binding agent, wet granulation and drying are carried out, 16g of magnesium stearate is added and mixed uniformly, and the mixture is filled into No. 2 capsules to be 10000 capsules, wherein each capsule contains 40mg of the extract, and the net weight of each capsule is 0.2 g. It is administered orally 2 times daily, 3 granules each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 32: preparation of pharmaceutical composition capsules of the present application
250g of the extract prepared in the example 1 is taken, and 580g of lactose and 1154g of starch are added and mixed uniformly, 350g of 7% starch slurry is used as a binding agent, wet granulation is carried out, drying is carried out, 16g of magnesium stearate is added and mixed uniformly, and the mixture is filled into No. 2 capsules to be 10000 capsules, wherein each capsule contains 25mg of the extract, and the net weight of each capsule is 0.2 g. It is administered orally 2 times daily, 3 granules each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 33: preparation of pharmaceutical composition granules of the present application
1000g of the extract prepared in example 1 was taken, 980g of lactose and 1004g of starch were added and mixed uniformly, 350g of 7% starch slurry was used as a binder, wet granulation was carried out, drying was carried out, 16g of magnesium stearate was added and mixed uniformly, the contents were filled in packaging bags and sealed to prepare 3333 bags, each bag of the granule contained 300mg of the extract, and the net weight of each bag was 0.6 g. It is administered orally 2 times daily, 1 bag each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 34: preparation of pharmaceutical composition granules of the present application
800g of the extract prepared in example 1 is taken, 980g of lactose and 1204g of starch are added and mixed uniformly, 350g of 7% starch slurry is used as a binding agent, wet granulation is carried out, drying is carried out, 16g of magnesium stearate is added and mixed uniformly, the content is filled into a packaging bag and sealed to prepare 3333 bags, each bag of the granule contains 240mg of the extract, and the net weight of each bag is 0.6 g. It is administered orally 2 times daily, 1 bag each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 35: preparation of pharmaceutical composition granules of the present application
500g of the extract prepared in example 1 is taken, 980g of lactose and 1504g of starch are added and mixed uniformly, 350g of 7% starch slurry is used as a binding agent, wet granulation is carried out, drying is carried out, 16g of magnesium stearate is added and mixed uniformly, the content is filled into a packaging bag and sealed, 3333 bags are prepared, 150mg of the extract is contained in each bag of granules, and the net weight of each bag is 0.6 g. It is administered orally 2 times daily, 1 bag each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 36: preparation of pharmaceutical composition granules of the present application
1000g of the extract prepared in example 1 was taken, 2984g of starch was added and mixed uniformly, 350g of 7% starch slurry was used as a binder, wet granulation was performed, drying was performed, 16g of magnesium stearate was added and mixed uniformly, the contents were filled in packaging bags and sealed to prepare 3333 bags, each bag of the granules contained 300mg of the extract, and each bag had a net weight of 0.6 g. It is administered orally 2 times daily, 1 bag each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 37: preparation of pharmaceutical composition granules of the present application
Taking 800g of the extract prepared in example 1, adding 3184g of starch, mixing uniformly, using 350g of 7% starch slurry as a binding agent, granulating by a wet method, drying, adding 16g of magnesium stearate, mixing uniformly, filling the contents into a packaging bag, sealing, and preparing 3333 bags, wherein each bag of the granule contains 240mg of the extract, and the net weight of each bag is 0.6 g. It is administered orally 2 times daily, 1 bag each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 38: preparation of pharmaceutical composition granules of the present application
500g of the extract prepared in example 1 is taken, 3484g of starch is added and mixed uniformly, 350g of 7% starch slurry is used as a binding agent, wet granulation is carried out, drying is carried out, 16g of magnesium stearate is added and mixed uniformly, the content is filled into a packaging bag and sealed, 3333 bags are prepared, 150mg of the extract is contained in each bag of the granules, and the net weight of each bag is 0.6 g. It is administered orally 2 times daily, 1 bag each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 39: preparation of pharmaceutical composition granules of the present application
1000g of the extract prepared in example 1 was taken, 1480g of lactose and 2504g of starch were added and mixed uniformly, 350g of 7% starch slurry was used as a binder, wet granulation was performed, drying was performed, 16g of magnesium stearate was added and mixed uniformly, the contents were packed in a package bag and sealed to prepare 3333 bags, each bag of the granule contained 300mg of the extract, and each bag had a net weight of 0.6 g. It is administered orally 2 times per day in 1 bag for resisting atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 40: preparation of pharmaceutical composition granules of the present application
800g of the extract prepared in example 1 is taken, lactose 1480g and starch 2704g are added and mixed uniformly, 350g of 7% starch slurry is used as a binding agent, wet granulation is carried out, drying is carried out, 16g of magnesium stearate is added and mixed uniformly, the content is filled into a packaging bag and sealed to prepare 3333 bags, each bag of the granule contains 240mg of the extract, and the net weight of each bag is 0.6 g. It is administered orally 2 times per day in 1 bag for resisting atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of skin.
Example 41: preparation of pharmaceutical composition granules of the present application
Taking 600g of the extract prepared in example 1, adding 1480g of lactose and 2904g of starch, mixing uniformly, using 350g of 7% starch slurry as a binding agent, granulating by a wet method, drying, adding 16g of magnesium stearate, mixing uniformly, packaging the content in a packaging bag, sealing, and preparing 3333 bags, wherein each bag of the granule contains 180mg of the extract, and the net weight of each bag is 0.6 g. It is administered orally 2 times daily, 1 bag each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 42: preparation of pharmaceutical composition granules of the present application
500g of the extract prepared in example 1 was taken, 1480g of lactose and 3004g of starch were added and mixed uniformly, 350g of 7% starch slurry was used as a binder, wet granulation was performed, drying was performed, 16g of magnesium stearate was added and mixed uniformly, the contents were packed in a package bag and sealed to prepare 3333 bags, each bag of the granule contained 150mg of the extract, and each bag had a net weight of 0.6 g. It is administered orally 2 times per day in 1 bag for resisting atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 43: preparation of pharmaceutical composition granules of the present application
400g of the extract prepared in example 1 was taken, 480g of lactose and 1104g of starch were added and mixed uniformly, 350g of 7% starch slurry was used as a binder, wet granulation was performed, drying was performed, 16g of magnesium stearate was added and mixed uniformly, the contents were filled in a packaging bag and sealed to prepare 3333 bags, each bag of the granule contained 120mg of the extract, and the net weight of each bag was 0.6 g. It is administered orally 2 times daily, 1 bag each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 44: preparation of pharmaceutical composition granules of the present application
250g of the extract prepared in example 1 is taken, added with 580g of lactose and 1154g of starch and evenly mixed, 350g of 7% starch slurry is used as a binding agent for wet granulation and drying, 16g of magnesium stearate is added and evenly mixed, the content is filled into a packaging bag and sealed to prepare 3333 bags, each bag of the granule contains 75mg of the extract, and the net weight of each bag is 0.6 g. It is administered orally 2 times daily, 1 bag each time, and can be used for treating atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 45: preparation of the pharmaceutical composition oral liquid of the present application
Taking 50g of the extract prepared in the example 1, adding a solubilizer, namely poloxamer and a certain proportion of ethanol, and fully stirring; adding appropriate additives (such as correctant, antibacterial agent, antioxidant, and colorant), dissolving, filtering, clarifying, packaging into ampoule or pop-top bottle, and sterilizing. The specification is that each bottle of oral liquid contains 166mg of extract, and the net content of each bottle is 10 mL. It is administered orally 1 bottle 1 time per day for resisting atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 46: preparation of the pharmaceutical composition oral liquid of the present application
Taking 100g of the extract prepared in the example 1, adding ethanol with a certain proportion, and fully stirring; adding appropriate additives (such as correctant, antibacterial agent, antioxidant, and colorant), dissolving, filtering, clarifying, packaging into ampoule or pop-top bottle, and sterilizing. The specification is that each bottle contains 300mg of the extract oral liquid, and the net content of each bottle is 10 mL. It is administered orally 1 bottle 1 time per day for resisting atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 47: preparation of the pharmaceutical composition oral liquid of the present application
Taking 200g of the extract prepared in the example 1, adding ethanol with a certain proportion, and fully stirring; adding appropriate additives (such as correctant, antibacterial agent, antioxidant, and colorant), dissolving, filtering, clarifying, packaging into ampoule or pop-top bottle, and sterilizing. The specification is that each bottle contains 600mg of the extract oral liquid, and the net content of each bottle is 10 mL. It is administered orally 1 bottle 1 time per day for resisting atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin
Example 48: preparation of the pharmaceutical composition oral liquid of the present application
Taking 300g of the extract prepared in the example 1, adding ethanol with a certain proportion, and fully stirring; adding appropriate additives (such as correctant, antibacterial agent, antioxidant, and colorant), dissolving, filtering, clarifying, packaging into ampoule or pop-top bottle, and sterilizing. The specification is that each bottle contains 900mg of the extract oral liquid, and the net content of each bottle is 10 mL. It is administered orally 1 bottle 1 time per day for resisting atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 49: preparation of the pharmaceutical composition oral liquid of the present application
Taking 400g of the extract prepared in the example 1, adding ethanol with a certain proportion, and fully stirring; adding appropriate additives (such as correctant, antibacterial agent, antioxidant, and colorant), dissolving, filtering, clarifying, packaging into ampoule or pop-top bottle, and sterilizing. The specification is that each bottle contains 1333mg of extract oral liquid, and the net content of each bottle is 10 mL. It is administered orally 1 bottle 1 time per day for resisting atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
Example 50: preparation of the pharmaceutical composition oral liquid of the present application
Taking 500g of the extract prepared in the example 1, adding ethanol with a certain proportion, and fully stirring; adding appropriate additives (such as correctant, antibacterial agent, antioxidant, and colorant), dissolving, filtering, clarifying, packaging into ampoule or pop-top bottle, and sterilizing. The specification is that each bottle of oral liquid contains 1666mg of extract, and the net content of each bottle is 10 mL. It is administered orally 1 bottle 1 time per day for resisting atopic dermatitis. The symptoms are as follows: erythema, edema, desquamation or lichenification of the skin.
It is to be understood that while the application is illustrated in certain forms, it is not limited to what has been shown and described herein. It will be apparent to those skilled in the art that various changes can be made without departing from the scope of the application. Such variations are within the scope of the claims of this application.
Reference to the literature
[1]Weidinger S,Novak N.Atopic dermatitis.The Lancet,2016,387(10023):1109-1122.
[2]Leung D Y M,Boguniewicz M,Howell M D,et al.New insights into atopic dermatitis[J].Journal of Clinical Investigation,2004,113(5):651-657.
[3]Brown S J.Molecular mechanisms in atopic eczema:insights gained from genetic studies[J].The Journal ofpathology,2017,241(2):140-145.
[4]Hanifin J M,Thurston M,Omoto M,et al.The eczema area and severity index(EASI):assessment of reliability in atopic dermatitis.EASI Evaluator Group.Experimental dermatology,2001,10(1):11-18.
[5]Takano N,Arai I,Kurachi M.Analysis of the spontaneous scratching behavior by NC/Nga mice:a possible approach to evaluate antipruritics for subjects with atopic dermatitis.Europeanjournal ofpharmacology,2003,471(3):223-228.
[6]Lazarski C A,Ford J,Katzman S D,et al.IL-4 attenuates Th1-associated chemokine expression and Th1 trafficking to inflamed tissues and limits pathogen clearance.PloS one,2013,8(8):e71949.
[7]Newell L,Polak M E,Perera J,et al.Sensitization via healthy skin programs Th2 responses in individuals with atopic dermatitis.The Journal of investigative dermatology,2013,133(10):2372-2380.
[8]Kabashima K.New concept ofthe pathogenesis of atopic dermatitis:interplay among the barrier,allergy,and pruritus as a trinity.Journal ofdermatological science,2013,70(1):3-11.
Claims (13)
1. The anti-dermatitis pharmaceutical composition comprises the following active ingredients in parts by weight:
6-50 parts of radix rehmanniae recen, 3-30 parts of radix paeoniae rubra, 3-30 parts of scutellaria baicalensis, 3-30 parts of phellodendron amurense, 3-30 parts of fructus forsythiae, 3-30 parts of semen plantaginis, 3-30 parts of phaseolus calcaratus, 6-40 parts of cortex dictamni and 3-30 parts of fructus kochiae.
2. The pharmaceutical composition of claim 1, wherein the weight ratio of the raw materials is as follows:
10-25 parts of radix rehmanniae recen, 5-15 parts of radix paeoniae rubra, 5-15 parts of scutellaria baicalensis, 5-15 parts of phellodendron amurense, 5-15 parts of fructus forsythiae, 5-15 parts of semen plantaginis, 5-15 parts of phaseolus calcaratus, 5-20 parts of cortex dictamni and 5-15 parts of fructus kochiae.
3. The pharmaceutical composition of claim 1 or 2, wherein the weight ratio of the raw materials is as follows:
20 parts of radix rehmanniae recen, 10 parts of radix paeoniae rubra, 10 parts of radix scutellariae, 10 parts of cortex phellodendri, 10 parts of fructus forsythiae, 10 parts of semen plantaginis, 10 parts of phaseolus calcaratus, 12 parts of cortex dictamni and 10 parts of fructus kochiae.
4. The pharmaceutical composition of claim 1 or 2, further comprising a pharmaceutically acceptable excipient selected from one or more of the following: binders, fillers, lubricants, solubilizers, flavoring agents, bacteriostats, antioxidants and colorants.
5. The pharmaceutical composition of claim 1 or 2, wherein the active ingredient is formulated into a pharmaceutically acceptable dosage form with a pharmaceutically acceptable excipient.
6. The pharmaceutical composition of claim 5, wherein the dosage form is a tablet, capsule, granule, pill, or oral liquid.
7. A method of preparing an anti-dermatitis pharmaceutical composition comprising:
(1) weighing the following raw materials in parts by weight: 6-50 parts of radix rehmanniae recen, 3-30 parts of radix paeoniae rubra, 3-30 parts of radix scutellariae, 3-30 parts of cortex phellodendri, 3-30 parts of fructus forsythiae, 3-30 parts of semen plantaginis, 3-30 parts of phaseolus calcaratus, 6-40 parts of cortex dictamni and 3-30 parts of fructus kochiae, adding ethanol, soaking for a period of time, extracting and filtering;
(2) recovering the filtrate obtained in step (1), and drying to obtain an extract; and optionally also (c) a second set of one or more of,
(3) adding pharmaceutically acceptable excipient into the extract obtained in the step (2) to prepare a pharmaceutically acceptable dosage form.
8. The method of claim 7, wherein the dosage form is a tablet, capsule, granule, pill, or oral liquid.
9. Use of a pharmaceutical composition according to any one of claims 1-6 in the manufacture of a medicament for treating or preventing an inflammatory skin disease in a subject, or for repairing a skin barrier in a subject.
10. The use of claim 9, wherein the inflammatory skin disease is an allergic inflammatory skin disease.
11. The use according to claim 10 wherein the disease is atopic dermatitis.
12. The use according to claim 9 or 10, wherein the medicament is administered orally or by gavage.
13. Use of a pharmaceutical composition according to any one of claims 1-6 for the preparation of a tablet, capsule, granule, pill or oral liquid for treating or preventing an inflammatory skin disease in a subject, or for repairing the skin barrier of a subject.
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