CN112755143B

CN112755143B - Traditional Chinese medicine composition for treating eczema and application thereof

Info

Publication number: CN112755143B
Application number: CN202110225033.6A
Authority: CN
Inventors: 刘晓春; 高鹏飞; 漆舒娴
Original assignee: Jinshan Hospital of Fudan University
Current assignee: Jinshan Hospital of Fudan University
Priority date: 2021-03-01
Filing date: 2021-03-01
Publication date: 2022-06-24
Anticipated expiration: 2041-03-01
Also published as: CN112755143A

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating eczema and application thereof, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 20-30 parts of folium artemisiae argyi, 30-60 parts of radix sophorae flavescentis, 4-9 parts of mint, 10-15 parts of wild chrysanthemum flower, 9-15 parts of radix stemonae, 9-15 parts of szechwan chinaberry fruit, 12-18 parts of spreading hedyotis herb, 9-15 parts of cortex dictamni, 6-12 parts of duckweed, 6-12 parts of pepper, 12-15 parts of mulberry leaf, 12-15 parts of fructus kochiae, 12-15 parts of honeysuckle flower and 15-30 parts of honeysuckle stem. The invention also comprises the application of the traditional Chinese medicine composition in preparing a medicine for treating eczema. Its advantages are: the raw material medicines and the weight part ratio thereof are optimized, the curative effect on treating acute eczema and large skin itching area caused by acute attack of chronic eczema is excellent, especially on children skin eczema, and the traditional Chinese medicine composition can be well applied to clinic.

Description

Traditional Chinese medicine composition for treating eczema and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating eczema and application thereof.

Background

Eczema is a skin inflammatory reaction with severe pruritus caused by various internal and external factors and is divided into three stages of acute stage, subacute stage and chronic stage. The acute stage is prone to exudation, while the chronic stage is infiltrative and hypertrophic. Some patients directly manifest chronic eczema. The skin lesion has the characteristics of polymorphism, symmetry, pruritus, easy repeated attack and the like. Eczema is a complex etiology, often resulting from the interaction of internal and external factors. Internal factors such as chronic digestive system diseases, mental stress, insomnia, overfatigue, mood changes, endocrine dyscrasia, infection, metabolism disorder and the like, and external factors such as living environment, climate changes, food and the like can influence the occurrence of eczema. External stimuli such as sunlight, cold, dryness, heat, hot water scald and washing, as well as various animal skins, plants, cosmetics, soaps, artificial fibers and the like can induce, and are a delayed allergic reaction caused by complicated internal and external factors.

Common acute eczema is skin inflammation with polymorphous rash and exudation tendency, accompanied by severe pruritus and easy recurrence. Acute eczema can occur in any part of the body, but is often easily seen in the head, the bent sides of the limbs, the pudendum, the dorsum of the hands and feet, and the like. They are usually distributed symmetrically and usually localized in some parts, but generalized eczema is rare. Skin lesions are characterized by polymorphism, i.e., erythema, papules, blisters, erosion, exudation, crusting, desquamation, and other forms of skin rash are seen in each other. The inflammatory reaction of the affected part is usually obvious, particularly the central part is more obvious and is often accompanied with erosion and exudation, but the disease damage boundary is not clear, the swelling is light, the subjective itching is severe, and the degree of the itching is different from the tolerance of the affected part and the individual. Itching is especially acute at night, and severe symptoms can affect sleep. And suppurative skin diseases such as folliculitis, furuncle, impetigo, lymphangitis, lymphadenitis and the like are caused by easy bacterial infection due to pruritus. Currently, most western medicines are treated by oral antihistamine medicines. Such as diphenhydramine, finasteride, chlorpheniramine, cyproheptadine, etc., can be used alone or in combination, or can be used in combination with sedative and vitamin C to improve therapeutic effect. The dosage form for external use is determined according to clinical skin damage, if the red swelling is obvious, the exudation is large, the solution should be selected for cold and wet compress, and lotion, emulsion, paste, oil agent and the like can be used for erythema and pimple; oil solution is needed for blister and erosion. Acute eczema is treated properly, so that inflammation is relieved, skin damage can be relieved after 2-3 weeks, but the acute eczema frequently occurs repeatedly and can be converted into subacute or chronic eczema.

In the period that acute eczema of infants is frequently found in infants at 0-2 years old, the infants commonly suffer from diseases in the first and second february after birth and also frequently suffer from diseases in the second and third months of life, the inflammation of the superficial dermis and epidermis caused by various internal and external factors is generally considered to be related to allergic reaction, the rash of the infants has polymorphism, is symmetrically distributed, is easy to exude, repeatedly attacks, and has spontaneous pruritus, is easy to develop into chronic, and has the characteristic of no scar left after healing. Therefore, the search for a medicament which can effectively treat the skin itch caused by acute eczema or acute attack of chronic eczema is urgent. The invention provides a medicine for effectively treating the disease aiming at the defect, and the traditional Chinese medicine composition for treating eczema and the application thereof are not reported at present.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for treating eczema and application thereof, aiming at the defects of the prior art.

In order to achieve the purpose, the invention adopts the technical scheme that:

in a first aspect, the invention provides a traditional Chinese medicine composition for treating eczema, which comprises the following raw material medicines in parts by weight: 20-30 parts of folium artemisiae argyi, 30-60 parts of radix sophorae flavescentis, 4-9 parts of mint, 10-15 parts of wild chrysanthemum flower, 9-15 parts of radix stemonae, 9-15 parts of szechwan chinaberry fruit, 12-18 parts of spreading hedyotis herb, 9-15 parts of cortex dictamni, 6-12 parts of duckweed, 6-12 parts of pepper, 12-15 parts of mulberry leaf, 12-15 parts of fructus kochiae, 12-15 parts of honeysuckle and 15-30 parts of honeysuckle stem.

Preferably, the traditional Chinese medicine composition consists of the following raw material medicines in parts by weight: 25-30 parts of folium artemisiae argyi, 40-60 parts of radix sophorae flavescentis, 6-9 parts of mint, 12-15 parts of wild chrysanthemum flower, 12-15 parts of radix stemonae, 9-12 parts of szechwan chinaberry fruit, 12-15 parts of spreading hedyotis herb, 12-15 parts of cortex dictamni, 6-10 parts of duckweed, 6-10 parts of pepper, 13-15 parts of mulberry leaf, 13-15 parts of fructus kochiae, 13-15 parts of honeysuckle flower and 25-30 parts of honeysuckle stem.

Preferably, the traditional Chinese medicine composition consists of the following raw material medicines in parts by weight: 30 parts of folium artemisiae argyi, 60 parts of radix sophorae flavescentis, 6 parts of mint, 15 parts of wild chrysanthemum flower, 15 parts of radix stemonae, 9 parts of szechwan chinaberry fruit, 12 parts of spreading hedyotis herb, 15 parts of cortex dictamni, 6 parts of duckweed, 6 parts of pepper, 15 parts of mulberry leaf, 15 parts of fructus kochiae, 15 parts of honeysuckle flower and 30 parts of honeysuckle stem.

Further, the traditional Chinese medicine composition also comprises a pharmaceutically acceptable carrier.

Furthermore, the traditional Chinese medicine composition is a clinically acceptable external preparation.

Preferably, the external dosage form comprises a spray, a liniment, an ointment, a lotion or a patch.

In a second aspect, the invention provides an application of the traditional Chinese medicine composition in preparing a medicine for treating eczema.

Furthermore, the invention provides application of the traditional Chinese medicine composition in preparing a medicine for treating skin itch caused by acute eczema and/or acute attack of chronic eczema.

Furthermore, the invention provides application of the traditional Chinese medicine composition in preparing a medicine for treating skin itch caused by acute eczema of children and/or acute attack of chronic eczema of children.

In a third aspect, the invention provides a lotion for treating eczema, which is prepared from the traditional Chinese medicine composition, and the preparation method of the lotion comprises the following steps:

(1) the raw materials are taken according to the weight part ratio, cleaned, put into an automatic purple sand traditional Chinese medicine decocting pot, added with water and soaked with strong fire for decocting for 0.5-1 hour;

(2) decocting with slow fire for 15-20 min;

(3) removing residue, filtering, and decocting in water for 1 time;

(4) mixing the filtrates, and cooling to 38-44 deg.C.

Square solution:

the etiology is as follows: eczema is caused by congenital and acquired factors, and internal factors such as improper diet damage to spleen and stomach, wind, dampness and heat cause heart, liver, spleen and lung to be affected by exposure to sensitizing substances. The treatment mainly aims at dispelling wind and eliminating dampness, clearing heat and detoxicating and relieving itching, and moistening dryness. In the formula, the folium artemisiae argyi and the radix sophorae flavescentis are used for removing dampness and relieving itching, and are used as monarch drugs in large amount; radix stemonae, pepper and raw toosendan fruit are used for killing parasites and relieving itching, cortex dictamni and broom cypress fruit are used for clearing heat, promoting diuresis, dispelling wind and relieving itching, and spreading hedyotis herb and honeysuckle flower are used as ministerial medicines for clearing heat and removing toxicity; the honeysuckle stem is used for dispelling wind and dredging collaterals, is matched with duckweed for dispersing and promoting eruption, inducing diuresis for removing edema, eliminating pathogenic factors from urine, and is used as an adjuvant drug together with mulberry leaves for dispelling wind, clearing heat and moistening dryness, mint for dispelling wind heat, and the cool property of the mint for dispelling wind and restricting the warm and dry property of the pepper and the folium artemisiae argyi.

The compatibility is characterized in that: the formula combines cold and warm, moistens dryness and supplements each other, and combines the medicines to play the main roles of dispelling wind and removing dampness, clearing heat and detoxicating and relieving itching and moisten dryness.

Term(s) for

As used herein, an ingredient of the term "pharmaceutically acceptable" is one that is suitable for use in humans and/or animals without undue adverse side effects (such as toxicity, irritation, and allergic response), i.e., at a reasonable benefit/risk ratio.

As used herein, the term "pharmaceutically acceptable carrier" refers to a carrier for administration of a therapeutic agent, including various excipients and diluents and the like. The term refers to such pharmaceutical carriers: they are not necessary active ingredients per se and are not excessively toxic after administration. Suitable carriers are well known to those of ordinary skill in the art. A thorough discussion of pharmaceutically acceptable excipients can be found in Remington's Pharmaceutical Sciences (mackpub.co., n.j.1991). Pharmaceutically acceptable carriers in the compositions may comprise liquids such as water, saline, glycerol and ethanol. In addition, auxiliary substances such as emulsifiers, fillers, binders, wetting agents, disintegrants, absorption enhancers, flavoring agents, colorants, cosolvents and the like may also be present in these carriers. The emulsifier is selected from acetylated monoglyceride, acetylated diglyceride, sucrose ester, sorbitol ester, soybean phospholipid, lauric monoglyceride, propylene glycol fatty acid ester, calcium stearoyl lactylate, diacetyl tartaric acid, glyceryl monostearate, modified soybean phospholipid, etc. Such as magnesium stearate, microcrystalline cellulose, lactose, milk sugar, high molecular weight polyethylene glycols, and the like. Such as starch, mannitol, silicic acid, dextrin, calcium hydrogen phosphate, cellulose, etc. Such as carboxymethyl cellulose, alginates, gelatin, polyvinyl pyrrolidone, gum arabic, starch slurry, hydroxypropyl starch, modified starch, pregelatinized starch, dextrin, microcrystalline cellulose, polyvinyl pyrrolidone mucilage, gelatin mucilage. Such as glycerin and the like. The disintegrating agent is agar, calcium carbonate, potato starch, tapioca starch, alginic acid, hydroxypropyl starch, modified starch, sodium carboxymethyl starch, microcrystalline cellulose, guar gum, xanthan gum, etc. The absorption enhancer is such as quaternary ammonium compound, effervescent agent, cyclodextrin, vitamin D and its derivatives, piperine, etc. The flavoring agent can be sour agent, sweetener, such as phosphoric acid, lactic acid, tartaric acid, malic acid, fumaric acid, acetic acid, succinic acid, xylitol, steviosin, sodium cyclamate, aspartame, oleum Menthae Dementholatum, etc. The colorant may be a plant colorant, an animal colorant or a microbial colorant, such as beet red, turmeric, chlorophyll, shellac, cochineal, red yeast colorant, and the like. The cosolvent is beta-cyclodextrin, maltodextrin, tween, ethanol, span, sodium dodecyl sulfate, propylene glycol, polyethylene glycol, glycerol and the like. However, it will be appreciated by those skilled in the art that the pharmaceutically acceptable carriers useful in the present invention are not limited to the above-mentioned types.

As used herein, "parts by weight" can be any fixed weight expressed in milligrams, grams, or kilograms (e.g., 1mg, 1g, 2g, 5g, or 1kg, etc.). For example, a composition consisting of 1 part by weight of component a and 9 parts by weight of component b may be a composition consisting of 1g of component a +9 g of component b, or 10 g of component a +90 g of component b. In the composition, the percentage content of a certain component is (parts by weight of the component/sum of parts by weight of all components) × 100%. Thus, in a composition consisting of 1 part by weight of component a and 9 parts by weight of component b, the content of component a is 10% and component b is 90%.

Dosage forms

The dosage form of the traditional Chinese medicine composition is not particularly limited, and can be any dosage form suitable for being taken by mammals; preferably, the dosage form may be selected from: spray, liniment, paste, lotion or patch.

The composition of the invention can be added with various conventional carriers or auxiliary materials required by preparing different dosage forms, such as filler (such as starch), flavoring agent (such as steviosin), antioxidant or coating material, and the like. Can be prepared into any common dosage form by conventional Chinese medicinal preparation method, such as spray, liniment, unguent, lotion or patch.

Preparation method

After knowing the raw materials and their formulation used in the Chinese medicinal composition of the present invention, those skilled in the art can use various conventional methods to process the raw materials into drugs. Such processing includes, but is not limited to: pulverizing, extracting with water, extracting with organic solvent, etc. More specifically, the process comprises, for example, the steps of: weighing, pulverizing, decocting, etc.

The raw materials can be mixed and then the effective components are extracted by a proper method to prepare the traditional Chinese medicine composition; in addition, the effective components can also be extracted respectively (for example, the same or different extraction or processing methods are adopted respectively) and then combined to prepare the traditional Chinese medicine composition.

In addition, the technicians in the field can also directly adopt the effective parts of the raw material medicines for processing so as to prepare the traditional Chinese medicine composition. Furthermore, those skilled in the art can extract active ingredients from the raw materials, mix and process the active ingredients to prepare the traditional Chinese medicine composition.

Optionally, other pharmaceutically (or dietetically or nutraceutically) acceptable carriers can be added during the preparation process.

Use and method of use

The traditional Chinese medicine composition can be directly used for treating acute eczema and skin pruritus caused by acute attack of chronic eczema. The traditional Chinese medicine composition can also contain other optional medicinal materials or medicinal material extracts.

The amount of the Chinese medicinal composition of the present invention to be used may vary depending on the mode of administration, the dosage form and the severity of the disease to be treated. For example, a single dose may be administered several times separately per day, or the dose may be reduced proportionally as required by the condition being treated. Of course, the particular dosage will also take into account such factors as the mode of administration, the physical condition of the subject being administered, and the like, which are within the skill of the art.

The invention has the advantages that:

1. the traditional Chinese medicine composition is prepared by optimally selecting raw materials and the weight part ratio thereof according to the etiology and pathogenesis of acute eczema, combining cold and warm in the whole formula, taking the functions of dispelling wind and removing dampness, clearing heat and removing toxicity and relieving itching as the treatment principle, and taking folium artemisiae argyi and radix sophorae flavescentis as the prescription for removing dampness and relieving itching, wherein the traditional Chinese medicine composition is a monarch drug with large dosage; radix stemonae, pepper and raw toosendan fruit are used for killing parasites and relieving itching, cortex dictamni and broom cypress fruit are used for clearing heat, promoting diuresis, dispelling wind and relieving itching, and spreading hedyotis herb and honeysuckle flower are used as ministerial medicines for clearing heat and removing toxicity; the honeysuckle stem has the effects of dispelling wind and dredging collaterals, is matched with duckweed for dispersing and promoting eruption, inducing diuresis for removing edema, discharging evil from urine, folium mori for dispelling wind, clearing heat and moistening dryness, mint for dispelling wind and heat, and the cooling property of the mint for dispelling wind and removing dampness, and the property of the folium mori for restricting the warm and dry properties of the pepper and the folium artemisiae argyi, and is used as an adjuvant with the wild chrysanthemum flower, so that the cold and warm components of the whole formula are combined, the dryness is relieved, the medicines are combined to play a role of dispelling wind and removing dampness, the heat and detoxifying for relieving itching, and the dryness is relieved.

2. The traditional Chinese medicine composition has no obvious adverse reaction or complication, and is safe and reliable.

3. The traditional Chinese medicine composition can be prepared into different formulations according to the convenience of patients or the requirements, is suitable for being prepared into a commercial compound preparation, is convenient to accept, and has wide application prospect.

Detailed Description

The invention will be further illustrated with reference to specific embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Furthermore, it should be understood that various changes and modifications can be made by those skilled in the art after reading the disclosure of the present invention, and equivalents fall within the scope of the appended claims.

EXAMPLE 1 Chinese medicinal composition 1

20 parts of folium artemisiae argyi, 30 parts of radix sophorae flavescentis, 4 parts of mint, 10 parts of wild chrysanthemum flower, 9 parts of radix stemonae, 9 parts of szechwan chinaberry fruit, 12 parts of spreading hedyotis herb, 9 parts of cortex dictamni, 6 parts of duckweed, 6 parts of pepper, 12 parts of mulberry leaf, 12 parts of fructus kochiae, 12 parts of honeysuckle flower and 15 parts of honeysuckle stem.

EXAMPLE 2 Chinese medicinal composition (II)

30 parts of folium artemisiae argyi, 60 parts of radix sophorae flavescentis, 9 parts of mint, 15 parts of wild chrysanthemum flower, 15 parts of radix stemonae, 15 parts of szechwan chinaberry fruit, 18 parts of spreading hedyotis herb, 15 parts of cortex dictamni, 12 parts of duckweed, 12 parts of pepper, 15 parts of mulberry leaf, 15 parts of fructus kochiae, 15 parts of honeysuckle flower and 30 parts of honeysuckle stem.

EXAMPLE 3 Chinese medicinal composition (III)

20 parts of folium artemisiae argyi, 60 parts of radix sophorae flavescentis, 4 parts of mint, 15 parts of wild chrysanthemum flower, 9 parts of radix stemonae, 15 parts of szechwan chinaberry fruit, 12 parts of spreading hedyotis herb, 15 parts of cortex dictamni, 6 parts of duckweed, 12 parts of pepper, 12 parts of mulberry leaf, 15 parts of fructus kochiae, 12 parts of honeysuckle flower and 30 parts of honeysuckle stem.

EXAMPLE 4 Chinese medicinal composition (IV)

30 parts of folium artemisiae argyi, 30 parts of radix sophorae flavescentis, 9 parts of mint, 10 parts of wild chrysanthemum flower, 15 parts of radix stemonae, 9 parts of szechwan chinaberry fruit, 18 parts of spreading hedyotis herb, 9 parts of cortex dictamni, 12 parts of duckweed, 6 parts of pepper, 15 parts of mulberry leaf, 12 parts of fructus kochiae, 15 parts of honeysuckle flower and 15 parts of honeysuckle stem.

EXAMPLE 5 Chinese medicinal composition (V)

25 parts of folium artemisiae argyi, 40 parts of radix sophorae flavescentis, 6 parts of mint, 12 parts of wild chrysanthemum flower, 12 parts of radix stemonae, 9 parts of szechwan chinaberry fruit, 12 parts of spreading hedyotis herb, 12 parts of cortex dictamni, 6 parts of duckweed, 6 parts of pepper, 13 parts of mulberry leaf, 13 parts of fructus kochiae, 13 parts of honeysuckle flower and 25 parts of honeysuckle stem.

EXAMPLE 6 Chinese medicinal composition (VI)

30 parts of folium artemisiae argyi, 60 parts of radix sophorae flavescentis, 9 parts of mint, 15 parts of wild chrysanthemum flower, 15 parts of radix stemonae, 12 parts of szechwan chinaberry fruit, 15 parts of spreading hedyotis herb, 15 parts of cortex dictamni, 10 parts of duckweed, 10 parts of pepper, 15 parts of mulberry leaf, 15 parts of fructus kochiae, 15 parts of honeysuckle flower and 30 parts of honeysuckle stem.

EXAMPLE 7 Chinese medicinal composition (seven)

25 parts of folium artemisiae argyi, 60 parts of radix sophorae flavescentis, 6 parts of mint, 15 parts of wild chrysanthemum flower, 12 parts of radix stemonae, 12 parts of szechwan chinaberry fruit, 12 parts of spreading hedyotis herb, 15 parts of cortex dictamni, 6 parts of duckweed, 10 parts of pepper, 13 parts of mulberry leaf, 15 parts of fructus kochiae, 13 parts of honeysuckle flower and 30 parts of honeysuckle stem.

EXAMPLE 8 Chinese medicinal composition (eight)

30 parts of folium artemisiae argyi, 40 parts of radix sophorae flavescentis, 9 parts of mint, 12 parts of wild chrysanthemum flower, 15 parts of radix stemonae, 9 parts of szechwan chinaberry fruit, 15 parts of spreading hedyotis herb, 12 parts of cortex dictamni, 10 parts of duckweed, 6 parts of pepper, 15 parts of mulberry leaf, 13 parts of fructus kochiae, 15 parts of honeysuckle flower and 25 parts of honeysuckle stem.

EXAMPLE 9 Chinese medicinal composition (nine)

30 parts of folium artemisiae argyi, 60 parts of radix sophorae flavescentis, 6 parts of mint, 15 parts of wild chrysanthemum flower, 15 parts of radix stemonae, 9 parts of szechwan chinaberry fruit, 12 parts of spreading hedyotis herb, 15 parts of cortex dictamni, 6 parts of duckweed, 6 parts of pepper, 15 parts of mulberry leaf, 15 parts of fructus kochiae, 15 parts of honeysuckle flower and 30 parts of honeysuckle stem.

Example 10 lotion

The preparation method comprises the following steps:

taking the raw materials in any one of the embodiments 1-9 according to the weight part ratio, cleaning, putting into an automatic purple sand traditional Chinese medicine decocting pot, adding cold water, decocting with strong fire, and soaking for 0.5-1 hour; decocting with slow fire for 15-20 min; removing residue, filtering, and decocting in water for 1 time; mixing the filtrates, and cooling to 38-44 deg.C.

EXAMPLE 11 liniment

The preparation method comprises the following steps:

the raw materials in the weight parts of any one of the embodiments 1-9 are respectively crushed into fine powder and then mixed or crushed into fine powder after being mixed, and the fine powder is sieved by a 400-mesh sieve for later use; and adding conventional adjuvants into the fine powder, and making into clinically acceptable liniment by conventional method.

Example 12 paste

The preparation method comprises the following steps:

taking the raw materials in any one of the embodiments 1-9 according to the weight part ratio, cleaning, putting into an automatic purple sand traditional Chinese medicine decocting pot, adding cold water, decocting with strong fire, and soaking for 0.5-1 hour; decocting with slow fire for 15-20 min; removing residue, filtering, and decocting in water for 1 time; mixing the filtrates, standing overnight, collecting supernatant, and concentrating to obtain extract with relative density of 1.1-1.2 at 60 deg.C; and (3) adding conventional auxiliary materials into the extract to prepare clinically acceptable paste according to a conventional process.

EXAMPLE 13 Patch preparation

The preparation method comprises the following steps:

taking the raw materials in any one of the embodiments 1-9 according to the weight part ratio, cleaning, putting into an automatic purple sand traditional Chinese medicine decocting pot, adding cold water, decocting with strong fire, and soaking for 0.5-1 hour; decocting with slow fire for 15-20 min; removing residue, filtering, and decocting in water for 1 time; mixing the filtrates, standing overnight, collecting supernatant, and concentrating to obtain extract with relative density of 1.1-1.2 at 60 deg.C; and (3) adding conventional auxiliary materials into the extract to prepare a clinically acceptable patch according to a conventional process.

Example 14 acute toxicity test

Taking 50 Kunming mice with half male and female bodies and 18-22 g of body weight, immediately dividing the mice into 5 groups, 10 mice in each group, wherein 4 groups are respectively drenched with the medicament prepared in the embodiment 1-4 of the invention, the drenching amount is 22 ml/(kg. d), the drenching amount is 40ml/kg, 1 time respectively in the morning, noon and evening, and the reaction conditions of the animals are immediately observed after administration, including the appearance, behavior activity, mental state, appetite, defecation and color, fur, nose, eyes and mouth of the animals, whether abnormal secretion exists or not and death conditions. And observing every 30min to 1h for 1 time on the 1 st day of administration, observing and weighing the body weight for 1 time every day, continuously observing for 14d, and recording animal toxicity reaction and death distribution condition as body weight change and reaction condition. The results show that the mice in 14d after the drug administration have normal activity, food intake and excretion, good growth, bright hair color, weight gain and no death, so no LD50 is detected. The average body weight thereof increased with the lapse of the test time, and was the same as that of the control group at the corresponding time. At the end of the observation period, the dead animal bodies are sacrificed and observed by naked eyes, and the mice of the administration group and the control group have no abnormal change of organs.

Example 15 Long term toxicity test

50 guinea pigs are selected, male and female halves are selected, the weight is 250 g-300 g, the guinea pigs are divided into 5 groups, each group comprises 10 guinea pigs, wherein 1 group of guinea pigs is a blank control group, and 4 groups of guinea pigs are respectively drenched with the medicament prepared in the invention in the embodiments 1-4, the stomach irrigation amount is 52 ml/(kg. d), 90 days are continuously carried out, the blank control group is given with equal amount of distilled water, the appearance and the behavior of animals are observed in the experiment, the weight is recorded, and after the administration of the medicament and fasting for 12 hours on the 90 th day, the routine examination of blood and urine and feces and the serum SGPT and BUN determination are carried out. Finally, the animals are killed by the 3% sodium pentobarbital in an excessive anesthesia mode, and the heart, the liver and the kidney are picked up for pathological examination, and the result shows that the observation indexes are not abnormally changed or the animals die. And (4) visual observation: the pleuroperitoneal cavity has no blood leakage, and the color, the size, the shape and the like of the organ administration group of heart, liver, kidney and the like have no obvious difference compared with the control group. And (3) histological observation: the tissue structures of the heart, the liver and the kidney of each group are normal, and no obvious pathological change is found compared with a control group.

EXAMPLE 16 clinical trial (one)

1 data of

1.1 general data

103 patients suffering from skin eczema who are diagnosed in the Jinshan Hospital affiliated to the university of Fudan in 2018, 6-2020 and 5 are selected and divided into three groups according to a random digital table method, wherein the three groups are respectively an experimental group, a control group and a control group, and the patients in each group have no significant difference in aspects of sex, age, course of disease and the like before treatment, and have good balance among the groups and comparability.

1.2 inclusion criteria

The age of the tea is 18-50 years old.

Secondly, the medicine accords with the acute eczema diagnosis standard in skin pathology (published by the national health publisher, 2002) and traditional Chinese medicine syndrome diagnosis curative effect standard issued by the national traditional Chinese medicine administration (published by 1994);

and thirdly, other medicines for treating acute eczema are not used before.

1.3 criteria for shedding

(1) Incomplete data will affect the final statistical data result.

(2) After inclusion, the false-selected person is found to be not in accordance with the inclusion standard, or the person in accordance with the exclusion standard.

2 method

2.1 methods of treatment

Experimental groups: the traditional Chinese medicine composition in the embodiment 9 is prepared into paste twice a day, 2-3 weeks are a treatment course, and the dosage of the medicine is reduced as appropriate for patients with small eczema.

Control group: applying the pimpines ointment externally for 3 times/d, 7 days for 1 treatment course, and 2 treatment courses in total.

Control two groups: the traditional Chinese medicine composition is used: 25 parts of folium artemisiae argyi, 65 parts of radix sophorae flavescentis, 10 parts of cortex phellodendri, 10 parts of rhizoma atractylodis, 10 parts of oldenlandia diffusa, 15 parts of dendrobe, 5 parts of codonopsis pilosula, 10 parts of divaricate saposhnikovia root and 10 parts of gallnut. The ointment is prepared twice a day, 2-3 weeks are a treatment course, and the dosage of the medicine is reduced as appropriate for patients with small eczema area.

2.2 therapeutic efficacy assessment criteria

According to the curative effect standard of acute eczema in the 'traditional Chinese medicine disease diagnosis curative effect standard' issued by the State administration of traditional Chinese medicine:

(1) and (3) healing: the rash is completely removed without itching feeling;

(2) the effect is shown: the rash subsides by more than 60 percent and has slight itching feeling;

(3) the method has the following advantages: the rash is reduced by 20-60%, and the itching feeling is slightly relieved;

(4) and (4) invalidation: the symptoms are unchanged compared with the symptoms before treatment, and the skin damage is expanded.

3 results

The results of the treatment effect and the recurrence rate of each group are shown in Table 1.

TABLE 1 curative effect and recurrence rate of each group

Toxic and side effects: after the treatment of the experimental group, the hematuria routine, the stool, the heart, the liver and the kidney function are rechecked, and no abnormality is found. The above cases were revisited after 3 months without recurrence. The experimental group has significant difference in total effective rate and recurrence rate compared with the control group and the control group.

EXAMPLE 17 clinical trial (two)

1 data of

1.1 general data

96 cases of children patients suffering from skin eczema and diagnosed in Jinshan Hospital affiliated to the university of Fudan in 2018, 6-2020 and 5 are selected, and are divided into three groups according to a random digital table method, wherein the three groups are respectively an experimental group, a control group and a control group, before treatment, the children patients in each group have no significant difference in the aspects of sex, age, course of disease and the like, and have good balance among the groups and comparability.

1.2 inclusion criteria

The age is 7d-22 months.

Secondly, the traditional Chinese medicine composition meets the acute eczema diagnosis standard in dermatology (published by people's health publishing house in 2002) and traditional Chinese medicine syndrome diagnosis curative effect standard issued by the national traditional Chinese medicine administration (published in 1994);

the skin itch area is large and the symptom caused by acute attack of chronic eczema is met;

fourthly, other medicines for treating eczema are not used before.

1.3 criteria for shedding

(1) Incomplete data will affect the final statistical data result.

2 method

2.1 methods of treatment

Experimental groups: the traditional Chinese medicine composition in the embodiment 9 is prepared into lotion, the children patients are externally washed for 15-20 minutes twice a day, 2-3 weeks are a treatment course, and the dosage of the medicine is reduced as appropriate for the patients with small eczema.

Control group: applying the pimpines ointment externally for 3 times/d, 7 days for 1 treatment course, and 1 treatment course.

Control two groups: the traditional Chinese medicine composition is used: 25 parts of folium artemisiae argyi, 65 parts of radix sophorae flavescentis, 10 parts of cortex phellodendri, 10 parts of rhizoma atractylodis, 10 parts of oldenlandia diffusa, 15 parts of dendrobe, 5 parts of codonopsis pilosula, 10 parts of radix sileris and 10 parts of gallnut. The lotion is prepared, the children patients are externally washed for 15-20 minutes each time, twice a day, 2-3 weeks are a treatment course, and the dosage of the medicine is reduced as appropriate for the patients with small eczema area.

2.2 therapeutic efficacy assessment criteria

And (3) healing: after a course of treatment; the infiltration liquid is completely absorbed, the erythema and the pimple are completely removed, and the subjective symptoms disappear.

The effect is shown: the exudate is completely absorbed, the erythema and pimple are obviously subsided by more than or equal to 70 percent, and the subjective symptoms are obviously improved.

The method has the following advantages: the exudate is basically absorbed, the erythema is more than or equal to 30 percent, the pimple is less than 80 percent, and the subjective symptoms are relieved.

And (4) invalidation: there was still little exudate, and the erythema and pimple resolved < 30%, even worsened.

3 results

The results of the treatment effect and the recurrence rate of each group are shown in Table 2.

TABLE 2 curative effect and recurrence rate of each group

The children patients are revisited after 3 months without recurrence. The experimental group has significant difference in total effective rate and recurrence rate compared with the control group and the control group.

The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and additions can be made without departing from the principle of the present invention, and these modifications and additions should also be regarded as the protection scope of the present invention.

Claims

1. The external traditional Chinese medicine composition for treating acute eczema is characterized by being prepared from the following raw material medicines in parts by weight: 20-30 parts of folium artemisiae argyi, 30-60 parts of radix sophorae flavescentis, 4-9 parts of mint, 10-15 parts of wild chrysanthemum flower, 9-15 parts of radix stemonae, 9-15 parts of szechwan chinaberry fruit, 12-18 parts of spreading hedyotis herb, 9-15 parts of cortex dictamni, 6-12 parts of duckweed, 6-12 parts of pepper, 12-15 parts of mulberry leaf, 12-15 parts of fructus kochiae, 12-15 parts of honeysuckle flower and 15-30 parts of honeysuckle stem.

2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 25-30 parts of folium artemisiae argyi, 40-60 parts of radix sophorae flavescentis, 6-9 parts of mint, 12-15 parts of wild chrysanthemum flower, 12-15 parts of radix stemonae, 9-12 parts of szechwan chinaberry fruit, 12-15 parts of spreading hedyotis herb, 12-15 parts of cortex dictamni, 6-10 parts of duckweed, 6-10 parts of pepper, 13-15 parts of mulberry leaf, 13-15 parts of fructus kochiae, 13-15 parts of honeysuckle flower and 25-30 parts of honeysuckle stem.

3. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 30 parts of folium artemisiae argyi, 60 parts of radix sophorae flavescentis, 6 parts of mint, 15 parts of wild chrysanthemum flower, 15 parts of radix stemonae, 9 parts of szechwan chinaberry fruit, 12 parts of spreading hedyotis herb, 15 parts of cortex dictamni, 6 parts of duckweed, 6 parts of pepper, 15 parts of mulberry leaf, 15 parts of fructus kochiae, 15 parts of honeysuckle flower and 30 parts of honeysuckle stem.

4. The Chinese medicinal composition of any one of claims 1-3, wherein the Chinese medicinal composition further comprises a pharmaceutically acceptable carrier.

5. The Chinese medicinal composition according to any one of claims 1 to 3, wherein the Chinese medicinal composition is in a clinically acceptable external preparation.

6. The composition of claim 5, wherein the topical dosage form comprises a spray, a liniment, a paste, a lotion, or a patch.

7. Use of the Chinese medicinal composition of any one of claims 1-3 for the preparation of a topical medicament for the treatment of acute eczema.

8. Use of a Chinese medicinal composition according to any one of claims 1 to 3 for the preparation of a medicament for the treatment of skin pruritus caused by acute eczema and/or acute episode of chronic eczema.

9. Use of the Chinese medicinal composition of any one of claims 1 to 3 for the preparation of a medicament for treating skin itch caused by acute eczema in children and/or acute attack of chronic eczema in children.

10. A lotion for treating acute eczema, which is prepared from the Chinese medicinal composition of any one of claims 1 to 3, and the preparation method of the lotion comprises the following steps:

(1) taking the raw materials according to the weight part ratio, cleaning, putting into an automatic purple sand traditional Chinese medicine decocting pot, adding water, soaking over strong fire, and decocting for 0.5-1 hour;

(2) decocting with slow fire for 15-20 min;

(3) removing residue, filtering, and decocting in water for 1 time;

(4) mixing the filtrates, and cooling to 38-44 deg.C.