CN115068567B

CN115068567B - Traditional Chinese medicine heat-clearing and dampness-eliminating paste and preparation method and application thereof

Info

Publication number: CN115068567B
Application number: CN202210797985.XA
Authority: CN
Inventors: 黄梅花
Original assignee: Individual
Current assignee: Huang Meihua; Shi Bin
Priority date: 2022-07-06
Filing date: 2022-07-06
Publication date: 2023-09-29
Anticipated expiration: 2042-07-06
Also published as: CN115068567A

Abstract

The invention relates to a traditional Chinese medicine heat-clearing and dampness-eliminating paste, a preparation method and application thereof, wherein the raw materials comprise the following components in parts by weight: 2-12 parts of amur corktree bark, 2-12 parts of lightyellow sophora root, 2-12 parts of glabrous greenbrier rhizome, 2-10 parts of raw largehead atractylodes rhizome, 2-10 parts of Indian buead, 2-10 parts of dittany bark, 2-10 parts of belvedere fruit, 2-8 parts of divaricate saposhnikovia root, 2-8 parts of cicada slough, 2-10 parts of swordlike atractylodes rhizome, 2-12 parts of raw coix seed, 2-8 parts of talcum, 2-10 parts of bitter orange, 2-8 parts of dried orange peel, 2-6 parts of liquoric root, 4-6 parts of donkey-hide gelatin and 20-40 parts of honey. The invention prepares the natural, safe and healthy traditional Chinese medicine ointment for clearing heat, drying dampness, dispelling wind and relieving itching by reasonably proportioning the raw material medicines and decocting the effective components in the traditional Chinese medicine, has good curative effect, adopts all natural plants as raw materials, does not contain heavy metals or toxicity, can be continuously taken for a long time, and is convenient to carry.

Description

Traditional Chinese medicine heat-clearing and dampness-eliminating paste and preparation method and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine heat-clearing and dampness-drying paste and a preparation method and application thereof.

Background

Eczema is a common skin disease in clinic, is itchy and erupted, can cause skin blistering and liquid seepage, is easy to repeatedly attack, and is developed into chronic eczema after a part of patients are not healed. The patient is not only afflicted with the body, but also is deeply afflicted with psychological pain, which seriously interferes with normal work and life. The incidence of eczema has increased 2-3 times in developed countries in recent 3 years. The incidence in children is 10-20% and in adults is 1-3%. In China, the incidence of eczema is also gradually increasing.

The specific etiology of eczema is unknown, and clinical studies are considered to be possibly related to allergic reactions, environmental factors, psychological factors and the like. Its pathogenesis is complex, including different genetically sensitive genes, the effects of environmental factors, infections, loss of skin barrier and immune responses. The Western medicine for treating eczema at present mainly adopts symptomatic treatment, including hormone, antiallergic, immunity regulating or mental medicine auxiliary treatment, although remarkable progress is achieved, partial patients still have the conditions of poor curative effect, high recurrence rate, multiple adverse reactions and the like after western medicine treatment, and partial patients develop into chronic eczema. Research shows that the traditional Chinese medicine has unique advantages in the aspect of treating eczema, not only can the eczema be cured by a simple traditional Chinese medicine preparation, but also the recurrence rate is low, and the economy is good. The cypress and poria cocos mixture is a pure traditional Chinese medicine preparation, and has the advantages of obvious curative effect, short treatment course, quick response, difficult recurrence after healing and the like in clinical application for many years.

The research shows that the traditional Chinese medicine has remarkable effect on eczema, and the traditional Chinese medicine has the advantages of low cost, definite curative effect, small side effect, strong and durable integral festival effect and the like, but the treatment course of the disease is long, the treatment is 3-6 months less, the treatment is more than 2 years or longer, many patients cannot adhere to the diagnosis and treatment of the system for various reasons, and the clinical cure rate has no new breakthrough for many years. In recent years, the traditional Chinese medicine ointment is more and more widely applied, and the dosage form is convenient to take and carry. The ointment is prepared into green nourishment by extraction and concentration, and can be generally taken by patients for about 30 days. The prepared soft extract is refrigerated, taken out for 10-15ml, and taken with warm boiled water, and is simple and convenient, and is not affected by meeting, leisure and travel or going out. Therefore, the traditional Chinese medicine ointment is accepted and accepted by more and more patients for treating skin diseases.

Disclosure of Invention

In order to overcome the defects of the prior art, the invention provides the traditional Chinese medicine heat-clearing and dampness-eliminating ointment which can treat eczema, has good curative effect on allergic dermatitis, urticaria, acne, chronic dermatitis and the like with damp-heat type, and has no side effect.

The invention provides the following technical scheme:

a traditional Chinese medicine ointment for clearing heat and drying dampness comprises the following raw materials in parts by weight: 2-12 parts of amur corktree bark, 2-12 parts of lightyellow sophora root, 2-12 parts of glabrous greenbrier rhizome, 2-10 parts of raw largehead atractylodes rhizome, 2-10 parts of Indian buead, 2-10 parts of dittany bark, 2-10 parts of belvedere fruit, 2-8 parts of divaricate saposhnikovia root, 2-8 parts of cicada slough, 2-10 parts of swordlike atractylodes rhizome, 2-12 parts of raw coix seed, 2-8 parts of talcum, 2-10 parts of bitter orange, 2-8 parts of dried orange peel, 2-6 parts of liquoric root, 4-6 parts of donkey-hide gelatin and 20-40 parts of honey.

Preferably, the raw materials comprise the following components in parts by weight: 4-10 parts of amur corktree bark, 4-10 parts of lightyellow sophora root, 4-10 parts of glabrous greenbrier rhizome, 4-8 parts of raw largehead atractylodes rhizome, 4-8 parts of Indian buead, 4-8 parts of dittany bark, 4-8 parts of belvedere fruit, 2-8 parts of divaricate saposhnikovia root, 2-8 parts of cicada slough, 4-8 parts of swordlike atractylodes rhizome, 4-10 parts of raw coix seed, 2-8 parts of talcum, 4-8 parts of bitter orange, 2-8 parts of dried orange peel, 2-6 parts of liquorice, 4-6 parts of donkey-hide gelatin and 30-40 parts of honey.

In any of the above schemes, the raw materials preferably comprise the following components in parts by weight: 6 parts of phellodendron, 6 parts of kuh-seng, 6 parts of glabrous greenbrier rhizome, 6 parts of raw bighead atractylodes rhizome, 4 parts of tuckahoe, 4 parts of cortex dictamni, 4 parts of belvedere fruit, 3 parts of divaricate saposhnikovia root, 3 parts of cicada slough, 4 parts of rhizoma atractylodis, 6 parts of raw coix seed, 4 parts of talcum, 5 parts of fructus aurantii, 4 parts of dried orange peel, 3 parts of liquorice, 4 parts of donkey-hide gelatin and 30 parts of honey.

In any of the above schemes, the raw materials preferably comprise the following components in parts by weight: 8 parts of amur corktree bark, 8 parts of lightyellow sophora root, 8 parts of glabrous greenbrier rhizome, 8 parts of raw largehead atractylodes rhizome, 8 parts of Indian buead, 6 parts of dittany bark, 6 parts of belvedere fruit, 6 parts of divaricate saposhnikovia root, 6 parts of cicada slough, 8 parts of swordlike atractylodes rhizome, 10 parts of raw coix seed, 6 parts of talcum, 6 parts of bitter orange, 6 parts of dried orange peel, 3 parts of liquoric root, 4 parts of donkey-hide gelatin and 40 parts of honey.

The invention also provides a preparation method of the traditional Chinese medicine heat-clearing and dampness-eliminating paste, which comprises the following steps:

(1) Soaking the medicine: soaking cortex Phellodendri, radix Sophorae Flavescentis, rhizoma Smilacis Glabrae, rhizoma Atractylodis Macrocephalae, poria, cortex Dictamni Radicis, kochiae fructus, radix Saposhnikoviae, periostracum Cicadae, rhizoma Atractylodis, radix Coicis semen, pulvis Talci, fructus Aurantii, pericarpium Citri Tangerinae and radix Glycyrrhrizae in water, adding 8-10 times of water, and soaking for 1-3 hr;

(2) Extracting: the method comprises the steps of (1) adopting a pressurized decoction method, decocting the medicinal materials soaked in the step for two times, wherein the decoction pressure is 1-1.5kg, the decoction temperature is 100-150 ℃, the decoction time is 50-80min each time, placing the liquid medicine obtained by the two times of decoction and squeezing, cooling and precipitating, and filtering the supernatant after precipitating by a 80-100-mesh screen to obtain filtrate for later use;

(3) Concentrating: heating the filtrate obtained in the step (2) at the working pressure of 0.2-0.3Mpa and the temperature of 115-124 ℃ with vapor pressure, boiling, removing surface froth, continuously stirring the filtrate, concentrating the filtrate to form thick paste-like clear paste, and taking concentrated liquid drops from the stick on dry kraft paper until the paste drops are not diffused and beads are formed;

(4) And (3) collecting paste: adding hot honey and donkey-hide gelatin into the concentrated fluid extract in the step (3), and continuously stirring at the working pressure of 0.2-0.35Mpa and the temperature of 118-125 ℃ to obtain the traditional Chinese medicine heat-clearing and dampness-eliminating paste with the relative density of 1.3-1.40.

When preparing the traditional Chinese medicine heat-clearing and dampness-eliminating paste, the step (1) is soaked, so that the effective components in the medicine are decocted; in the step (2), the water is ensured to completely submerge the medicinal materials during decoction; step 3) continuously stirring the liquid medicine during concentration to prevent coking and overflow; and (3) continuously stirring in the step (4) to avoid sticking the bottom and coking. And meanwhile, the exhaust fan is turned on to accelerate the evaporation of the exhaust fan, and the fire power is kept to be minimum along with the continuous evaporation of water.

In the above scheme, it is preferable that 9 times of water is added in the step (1) and soaked for 2 hours.

In any of the above schemes, preferably, the decoction pressure in the step (2) is 1.2kg, the decoction temperature is 120 ℃, and the decoction time is 60min each time.

In any of the above schemes, preferably, in the step (2), the liquid medicine obtained by decocting and squeezing twice is placed for cooling and precipitation, and the supernatant is taken after precipitation and filtered by a 100-mesh screen to obtain filtrate for standby.

In any of the above schemes, preferably, the decoction pressure in the step (3) is 1.2kg, the decoction temperature is 120 ℃, and the decoction time is 60min each time.

In any of the above schemes, preferably, in the step (3), the liquid medicine obtained by decocting and squeezing twice is placed for cooling and precipitation, and the supernatant is taken after precipitation and filtered by a 80-mesh screen to obtain filtrate for standby.

In any of the above schemes, it is preferable that the working pressure of the step (4) is 0.3Mpa and the temperature is 120 ℃.

In any of the above schemes, it is preferable that the working pressure of the step (5) is 0.3Mpa and the temperature is 125 ℃.

In any of the above schemes, preferably, the relative density of the traditional Chinese medicine heat-clearing and dampness-drying paste in the step (5) is controlled to be 1.40.

In any of the above schemes, preferably, the method further comprises the step of (6) sub-packaging and cooling paste: selecting a clean room with the clean grade of 10 ten thousand and the temperature of less than 20 ℃, subpackaging the soft extract obtained in the step (5) by heat, standing for 24 hours at normal temperature after subpackaging, and storing in a freezer after sealing a cover, wherein the standing time is less than 3 months.

In any of the above embodiments, it is preferable that the donkey-hide gelatin of step (5) is previously refined or melted by heating.

The invention also provides application of the traditional Chinese medicine heat-clearing and dampness-eliminating paste in preparing an external medicine for treating eczema.

The invention also provides application of the traditional Chinese medicine heat-clearing and dampness-eliminating paste in preparing medicines for treating allergic dermatitis, urticaria, acne and chronic dermatitis.

The raw material medicaments and the pharmaceutical excipients used in the invention have all indexes which accord with the records of 2015 edition of pharmacopoeia of the people's republic of China. The medicine is prepared from cortex phellodendri, radix sophorae flavescentis, rhizoma smilacis glabrae, raw bighead atractylodes rhizome, poria cocos, cortex dictamni, fructus kochiae, radix saposhnikoviae, periostracum cicadae, rhizoma atractylodis, raw coix seed, talcum, fructus aurantii, dried orange peel and liquorice. In the recipe, huang Bai clears heat and eliminates dampness, and is good at clearing damp-heat in lower energizer. The kuh-seng has the effects of clearing heat and drying dampness, is used for treating pruritus vulvae, eczema and scabies, and dysuria, and has the effects of clearing heat and drying dampness together. In the recipe, the wind-proof and cicada slough is used for developing striae and striae, and wind evil on the exterior is thoroughly relieved as the main medicine; because of the overflow of water flow caused by the damp-heat phase pulsation, the Chinese atractylodes is bitten and warm, and the wind and damp are dispersed; the prescription selects the medicines with the effects of drying dampness and promoting diuresis, such as the cortex dictamni, the fructus kochiae, the glabrous greenbrier rhizome, the fried pearl barley and the like, and simultaneously selects the medicines with the effects of strengthening spleen and regulating qi, such as the bighead atractylodes rhizome, the dried orange peel and the like, so as to achieve the purposes of strengthening spleen, promoting diuresis and relieving itching. Poria and rhizoma Atractylodis Macrocephalae have effects of promoting diuresis, removing dampness, strengthening spleen, regulating stomach, tranquilizing mind, invigorating spleen, nourishing heart, promoting diuresis, removing dampness, strengthening body resistance, and eliminating pathogenic factors. Talc Xin Han is used for treating heat, bitter and cold with the effect of purging its fire, and is combined with Fang Feng to promote and dispel spleen to promote fire, so as to clear up and down, clear down and promote and dispel fire, so that it can clear down without damaging spleen and stomach yang, promote and dispel fire due to depression. Licorice root, radix Glycyrrhizae has the effect of removing toxic substances and regulating the functions of the above-mentioned herbs. The main drugs are combined to have the effects of dispelling wind, clearing heat, removing dampness and relieving itching.

The invention has the beneficial effects that: the invention prepares the natural, safe and healthy traditional Chinese medicine ointment for clearing heat and drying dampness by reasonably proportioning the raw materials and auxiliary materials and decocting and concentrating and fusing the effective components in the traditional Chinese medicine for a long time, has good curative effect in clinic for many years, has no toxic traditional Chinese medicine because the traditional Chinese medicine is all natural plant sources, does not contain heavy metals (such as lead, mercury and arsenic) or toxic components (such as potassium fluotitanate), can be continuously taken for a long time, has no occurrence of adverse events in clinic for many years, is convenient to take and carry, and is accepted and accepted by more patients. The ointment combines traditional medicine, evidence-based medicine and clinical practice, not only maintains the traditional characteristics of traditional Chinese medicine, but also avoids lack of evidence-based basis, and can more objectively count curative effects.

Detailed Description

The present invention will be described in detail with reference to specific examples for further understanding of technical features of the present invention. The examples are given solely for the purpose of illustration and are not intended to be limiting, as any insubstantial modifications made by a person skilled in the art based on the description herein shall fall within the scope of the invention.

Example 1: traditional Chinese medicine heat-clearing and dampness-eliminating paste

Prescription: 4 parts of phellodendron, 4 parts of kuh-seng, 4 parts of glabrous greenbrier rhizome, 4 parts of raw bighead atractylodes rhizome, 4 parts of Indian buead, 4 parts of dittany bark, 4 parts of belvedere fruit, 3 parts of divaricate saposhnikovia root, 3 parts of cicada slough, 4 parts of swordlike atractylodes rhizome, 4 parts of raw coix seed, 3 parts of talcum, 3 parts of bitter orange, 4 parts of dried orange peel, 3 parts of liquorice, 4 parts of donkey-hide gelatin and 30 parts of honey.

The preparation method of the traditional Chinese medicine heat-clearing and dampness-eliminating paste comprises the following steps:

(1) Soaking the medicine: soaking cortex Phellodendri, radix Sophorae Flavescentis, rhizoma Smilacis Glabrae, rhizoma Atractylodis Macrocephalae, poria, cortex Dictamni, fructus Kochiae, radix Saposhnikoviae, periostracum Cicadae, rhizoma Atractylodis, radix Coicis semen, talcum, fructus Aurantii, pericarpium Citri Reticulatae, and radix Glycyrrhizae in water, adding 9 times of water, and soaking for 2 hours;

the drinking water can be used for soaking medicines, and the quality of the drinking water accords with international sanitary standard of drinking water;

(2) Extracting: the method comprises the steps of adopting a pressurized decoction method, decocting the medicinal materials soaked in the step 1) twice, wherein the decoction pressure is 1.2kg, the decoction temperature is 120 ℃, the decoction time is 60 minutes each time, placing the liquid medicine obtained by the two times of decoction and squeezing, cooling and precipitating, and filtering the supernatant after precipitating by a 80-mesh screen to obtain filtrate for later use;

the single electric decocting machine (micro-pressure circulation) of the decocting equipment can be adopted, the specification is 4 ten thousand ml, and YJ20B-G airtight decocting machine is produced by Beijing Donghua original medical equipment Co., ltd.

(3) Concentrating: heating the filtrate obtained in the step 2) at the working pressure of 0.3Mpa and the temperature of 120 ℃ by vapor pressure, boiling, removing surface foam, continuously stirring the liquid medicine, concentrating the liquid medicine to form thick paste-like clear paste, taking concentrated liquid drops from a stick to dry kraft paper at the moment, and taking the thick paste drops to be in the form of beads when the paste drops are not diffused;

the concentrating device may be a steam jacketed kettle (model: GT6J 1C), capacity 100L,

(4) And (3) collecting paste: adding hot honey and donkey-hide gelatin into the concentrated clear paste in the step 3), and continuously stirring at the working pressure of 0.3Mpa and the temperature of 125 ℃ to obtain the traditional Chinese medicine heat-clearing and dampness-eliminating paste with the relative density of 1.40;

the paste collecting equipment is a steam jacketed kettle (model: GT6J0.5C) produced by strong mechanical limited company in Shandong, and the capacity is 50L;

(5) Subpackaging and cooling paste: the cool paste and the packaging room are clean rooms, the cleaning grade is 10 ten thousand grades, the temperature is below 20 ℃, the soft extract is poured into an automatic packaging machine, and the soft extract is rapidly packaged into porcelain cans (the volume is 500 ml) which are cleaned and sterilized in advance. And (3) placing for 24 hours at normal temperature after sub-packaging, sealing a cover, and placing in a freezer for storage for 3 months at maximum.

Example 2: traditional Chinese medicine heat-clearing and dampness-eliminating paste

Prescription: 6 parts of phellodendron, 6 parts of kuh-seng, 6 parts of glabrous greenbrier rhizome, 6 parts of raw bighead atractylodes rhizome, 4 parts of tuckahoe, 4 parts of cortex dictamni, 4 parts of belvedere fruit, 3 parts of divaricate saposhnikovia root, 3 parts of cicada slough, 4 parts of rhizoma atractylodis, 6 parts of raw coix seed, 4 parts of talcum, 5 parts of fructus aurantii, 4 parts of dried orange peel, 3 parts of liquorice, 4 parts of donkey-hide gelatin and 30 parts of honey.

The preparation method of the traditional Chinese medicine heat-clearing and dampness-eliminating paste is the same as that of the embodiment 1.

Example 3: traditional Chinese medicine heat-clearing and dampness-eliminating paste

Prescription: 8 parts of amur corktree bark, 8 parts of lightyellow sophora root, 8 parts of glabrous greenbrier rhizome, 8 parts of raw largehead atractylodes rhizome, 8 parts of Indian buead, 6 parts of dittany bark, 6 parts of belvedere fruit, 6 parts of divaricate saposhnikovia root, 6 parts of cicada slough, 8 parts of swordlike atractylodes rhizome, 10 parts of raw coix seed, 6 parts of talcum, 6 parts of bitter orange, 6 parts of dried orange peel, 3 parts of liquoric root, 4 parts of donkey-hide gelatin and 30 parts of honey.

Example 4: traditional Chinese medicine heat-clearing and dampness-eliminating paste

Prescription: 10 parts of amur corktree bark, 10 parts of lightyellow sophora root, 10 parts of glabrous greenbrier rhizome, 10 parts of raw largehead atractylodes rhizome, 10 parts of Indian buead, 8 parts of dittany bark, 8 parts of belvedere fruit, 8 parts of divaricate saposhnikovia root, 8 parts of cicada slough, 10 parts of swordlike atractylodes rhizome, 10 parts of raw coix seed, 8 parts of talcum, 8 parts of bitter orange, 6 parts of dried orange peel, 4 parts of liquoric root, 4 parts of donkey-hide gelatin and 40 parts of honey.

Example 5: traditional Chinese medicine heat-clearing and dampness-eliminating paste

Prescription: 12 parts of amur corktree bark, 12 parts of lightyellow sophora root, 12 parts of glabrous greenbrier rhizome, 10 parts of raw largehead atractylodes rhizome, 10 parts of Indian buead, 8 parts of dittany bark, 10 parts of belvedere fruit, 6 parts of divaricate saposhnikovia root, 6 parts of cicada slough, 10 parts of swordlike atractylodes rhizome, 10 parts of raw coix seed, 8 parts of talcum, 10 parts of bitter orange, 6 parts of dried orange peel, 6 parts of liquoric root, 6 parts of donkey-hide gelatin and 40 parts of honey.

Example 6: traditional Chinese medicine heat-clearing and dampness-eliminating paste

Prescription: 12 parts of amur corktree bark, 12 parts of lightyellow sophora root, 12 parts of glabrous greenbrier rhizome, 10 parts of raw largehead atractylodes rhizome, 10 parts of Indian buead, 10 parts of dittany bark, 10 parts of belvedere fruit, 8 parts of divaricate saposhnikovia root, 8 parts of cicada slough, 10 parts of swordlike atractylodes rhizome, 12 parts of raw coix seed, 8 parts of talcum, 10 parts of bitter orange, 8 parts of tangerine peel, 6 parts of liquoric root, 6 parts of donkey-hide gelatin and 40 parts of honey.

Example 7: traditional Chinese medicine heat-clearing and dampness-eliminating paste

The formulation of this example was the same as that of example 5, except for the preparation method.

(1) Soaking the medicine: soaking cortex Phellodendri, radix Sophorae Flavescentis, rhizoma Smilacis Glabrae, rhizoma Atractylodis Macrocephalae, poria, cortex Dictamni Radicis, kochiae fructus, radix Saposhnikoviae, periostracum Cicadae, rhizoma Atractylodis, radix Coicis semen, pulvis Talci, fructus Aurantii, pericarpium Citri Tangerinae and radix Glycyrrhrizae in water, adding 8 times of water, and soaking for 1 hr;

(2) Extracting: the method comprises the steps of adopting a pressurized decoction method, decocting the medicinal materials soaked in the step 1) twice, wherein the decoction pressure is 1kg, the decoction temperature is 100 ℃, the decoction time is 50min each time, placing the liquid medicine obtained by the two times of decoction and squeezing, cooling and precipitating, and filtering the supernatant after precipitating by a 80-mesh screen to obtain filtrate for later use;

(3) Concentrating: heating the filtrate obtained in the step (2) at the working pressure of 0.2Mpa and the temperature of 115 ℃ by vapor pressure, boiling, removing surface foam, continuously stirring the liquid medicine, concentrating the liquid medicine to form thick paste-like clear paste, taking concentrated liquid drops from a stick to dry kraft paper at the moment, and taking the thick paste drops to be in the form of beads when the paste drops are not diffused;

(4) And (3) collecting paste: adding hot honey and donkey-hide gelatin into the concentrated clear paste in the step (3), and continuously stirring at the working pressure of 0.2Mpa and the temperature of 118 ℃ to obtain the traditional Chinese medicine heat-clearing and dampness-eliminating paste with the relative density of 1.30;

(5) Subpackaging and cooling paste: selecting a clean room with the clean grade of 10 ten thousand and the temperature of less than 20 ℃, subpackaging the soft extract obtained in the step 5) by heat, standing for 24 hours at normal temperature after subpackaging, and storing in a freezer after sealing by a cover, wherein the standing time is at most 3 months.

Example 8: traditional Chinese medicine heat-clearing and dampness-eliminating paste

The formulation of this example was the same as that of example 6, except for the preparation method.

(1) Soaking the medicine: soaking cortex Phellodendri, radix Sophorae Flavescentis, rhizoma Smilacis Glabrae, rhizoma Atractylodis Macrocephalae, poria, cortex Dictamni Radicis, kochiae fructus, radix Saposhnikoviae, periostracum Cicadae, rhizoma Atractylodis, radix Coicis semen, pulvis Talci, fructus Aurantii, pericarpium Citri Tangerinae and radix Glycyrrhrizae in water, adding 10 times of water, and soaking for 3 hr;

(2) Extracting: the method comprises the steps of (1) adopting a pressurized decoction method, decocting the medicinal materials soaked in the step for two times, wherein the decoction pressure is 1.5kg, the decoction temperature is 150 ℃, the decoction time is 80 minutes each time, placing the liquid medicine obtained by the two times of decoction and squeezing, cooling and precipitating, and filtering the supernatant after precipitating by a 100-mesh screen to obtain filtrate for later use;

(3) Concentrating: heating the filtrate obtained in the step (2) at the working pressure of 0.3Mpa and the temperature of 124 ℃ by vapor pressure, boiling, removing surface foam, continuously stirring the liquid medicine, concentrating the liquid medicine to form thick paste-like clear paste, taking concentrated liquid drops from a stick to dry kraft paper at the moment, and taking the thick paste drops to be in the form of beads when the paste drops are not diffused;

(4) And (3) collecting paste: adding hot honey and donkey-hide gelatin into the concentrated clear paste in the step (3), and continuously stirring at the working pressure of 0.35Mpa and the temperature of 125 ℃ to obtain the traditional Chinese medicine heat-clearing and dampness-eliminating paste with the relative density of 1.30;

Example 9: the clinical experimental example of the traditional Chinese medicine heat-clearing and dampness-drying plaster

1. Data and method

1. Case sources all cases come from the medical centers of Chinese medicine in the people hospitals in the Shiwei city of Hubei province in 1 month in 2020 to 3 months in 2022, and 140 cases are taken out of the clinic in the department of dermatology. The random double blind group was divided into 7 groups, example 1 group 20, example 2 group 20, example 3 group 20, example 4 group 20, example 5 group 20, example 6 group 20, cetirizine group 20.

2. Inclusion of case criteria

2.1, patients meeting the above diagnosis standards of traditional Chinese medicine and western medicine;

2.2, informed consent, voluntary patients;

2.3 patients between 18 and 65 years of age;

2.4, patients without traditional Chinese medicine allergy history and allergy to certain components of the test medicine or the control medicine;

2.5, patients with severe primary diseases of the heart, cerebral vessels, hematopoietic system, liver and kidney, and psychosis;

patients who had not taken steroid hormones within about 2 weeks, had not used antihistamines or topical corticosteroid preparations within about 1 week.

3. Rule of case elimination

3.1, patients who do not meet the diagnosis standards of traditional Chinese and Western medicine;

3.2, women under 18 years of age, over 65 years of age, pregnant or lactating;

3.3, in the last 2 weeks, steroid hormone and/or in the last 1 week, antihistamine, topical corticosteroid preparation;

3.4, a person who has a history of allergy to the traditional Chinese medicine and is allergic to a certain component of the test medicine or the control medicine;

3.5, patients with severe primary diseases such as heart, cerebral vessels, liver, kidney, hematopoietic system and the like, psychosis;

and 3.6, other cases which do not meet inclusion criteria.

4. Reject criteria

4.1, cases which are not in compliance with the inclusion standard and are included by mistake, or cases which are not treated according to the requirement after the inclusion standard is met;

4.2, the incomplete data affects the efficacy or safety judgment;

4.3, adverse reactions occur in the treatment process;

4.4, cases without bacterial smear and culture.

5. Drop criteria

5.1, accident happens in the treatment process and the person who can not adhere to the treatment can not stay;

5.2, poor compliance in the treatment process, and no patients who are not matched with the treatment;

5.3, in the course of treatment, treatment is not carried out according to a prescribed regimen, or other therapies or medicines are combined to make judgment impossible.

6. Treatment method and treatment course

6.1, examples 1-6 the pastes prepared in the pharmaceutical department of the people's medical department of Shiwei city, 2 times a day, 10ml each time, were taken with warm water. Taken warm 30 minutes after meals, 1 week is a course of treatment. Cetirizine group: the cetirizine tablet is orally taken 1 time a day, 10mg each time, and 1 week of oral administration is a treatment course.

6.2 treatment sessions the patients entered the group were treated for 3 weeks as a treatment session.

7. Observation index

Clinical observations mainly include the following symptoms and signs: itching, exudation, skin lesion area, skin lesion severity, etc. All clinical observation indexes and scoring judgment standards are set by referring to the relevant regulations of Liu Qiao main code of traditional Chinese medicine dermatology diagnosis and treatment science [3], zhengyu main code of traditional Chinese medicine new medicine clinical study guiding principle [4] and Zhao Bian "eczema area and severity index scoring method [5 ].

8. Statistical analysis method

The data collected in the clinical trial study were all statistically analyzed using SPSS 21.0 software, and different statistical methods were used depending on the statistical characteristics of the data collected in the clinical study. The metrology data are expressed as mean ± standard deviation (x ± s). The count data is analyzed by a chi-square (X2) test process. For each group of data, firstly, searching whether the data accords with normal distribution and variance alignment by using statistical software, and adopting t-test analysis processing for a tester which simultaneously meets the normal distribution and variance alignment; and if not, adopting non-parameter inspection statistical analysis. And obtaining a statistical result and a corresponding P value according to the correlation test, wherein if P is smaller than 0.05, the result has statistical significance, and if P is larger than 0.05, the result has no statistical significance.

2. Results

1. General data analysis table 1 shows a comparative analysis of general data for seven cases prior to treatment, with the age of 64 years at maximum, 22 years at minimum, and the average age of 47.63 and 12.12 years. The shortest disease course is 3.9 months, the longest disease course is 36 months, and the average disease course is 16.3 and 12.3 months. The comparison difference of seven groups of cases in terms of age and course of disease has no statistical significance (P > 0.05), and has comparability.

Table 1 age and course of seven groups of cases

Group of	n (human)	Average age (age)	Course of disease (moon)
				Example 1 group	20	49.40 shi 13.03	14.6 th Strand 14.3
Example 2 group	20	47.54 Shi 12.12	15.3 shi 16.7
				Example 3 group	20	48.32 Shi 12.93	17.4 th Stroke 15.7
Example 4 group	20	47.67 Shi 13.12	18.7 shi 18.9
				Example 5 group	20	48.83 Shi 13.10	15.6 th Strand 12.7 th Strand
Example 6 group	20	49.72 th shi 13.22	16.6 th Strand 14.6
				Cetirizine group	20	48.51 th 12.82 th	18.3 shi 12.8

2. Comparison of the itching degree before and after seven groups of treatments

The scores of the pruritus degree of the seven groups of patients before treatment are not significantly different (P > 0.05), and the patients are comparable; seven groups had an average degree of pruritus of 2.70 s of 0.405 score before treatment, seven groups had an average degree of pruritus of 1.15 s of 0.521 score after treatment, and the degree scores of the examples were statistically different (P < 0.05) from those before treatment; the cetirizine group pruritus degree score was statistically different (P < 0.05) from the pre-treatment comparison. The scores of the pruritus degree of the seven groups of patients after treatment were statistically different (P < 0.05). The comparison of the scores before and after treatment for the pruritus degree of the groups of examples 3-6 was significantly better than that of the cetirizine group, and the group of example 6 was more pronounced.

Table 2 comparison of scores of pruritus degree before and after treatment for seven groups

3. Comparison of exudation before and after seven groups of treatments

Seven groups of pre-treatment patients had no significant difference in exudation degree scores (P > 0.05), with comparability; seven groups had an average exudation of 2.72 s of 0.479 score before treatment and seven groups had an average exudation of 0.87 s of 0.556 score after treatment, with statistical differences (P < 0.05) between the exudation degree scores of the example groups compared to those before treatment; the cetirizine group exudation degree scores were statistically different (P < 0.05) from the pre-treatment comparisons. The exudation scores of the seven groups of treated patients were statistically different (P < 0.05). The comparison of the exudation degree scores before and after treatment was significantly better for the examples 3-6 groups than for the cetirizine group, and more significantly for the example 6 group.

Table 3 comparison of the scores of the exudation degree before and after treatment in seven groups

4. Seven groups of comparison of skin damage morphology before and after treatment

The skin damage morphology scores of seven groups of patients before treatment have no significant difference (P > 0.05), and are comparable; seven groups of average skin lesions before treatment are 2.50 s and 0.702 min, seven groups of average exudation after treatment are 0.87 s and 0.759 min, and the skin lesions of each example group have statistically different scores (P < 0.05) compared with the skin lesions before treatment; the cetirizine group skin lesion morphology scores were statistically different (P < 0.05) compared to pre-treatment. The skin lesion morphology scores of the seven groups of treated patients were statistically different (P < 0.05). The comparison of the skin lesion morphology scores before and after treatment was significantly better for the examples 2-6 than for the cetirizine group and more pronounced for the example 6 group.

Table 4 comparison of morphology scores of skin lesions before and after seven groups of treatments

5. Comparison of total efficacy after seven groups of treatments

After treatment, the total effective rates of the groups of examples 1-6 were 80%, 85%, 90%, 100%, respectively, and the total effective rate of the cetirizine group was 80%. Prompting: the treatment effect of the embodiment group is obvious, wherein the total effective rate of the embodiment 3-6 groups is high in the Yu Xiti ligustrazine group, and the treatment effect of the embodiment 6 groups is optimal.

Table 4 comparison of total effective rates after seven groups of treatments

3. Conclusion(s)

In the clinical study, the difference of the seven groups of general data is not statistically significant (P is more than 0.05), and the seven groups of general data are comparable. After treatment, the total effective rate of the example groups is 80%, 85%, 90% and 100%, respectively. The total effective rate of cetirizine group is 80%. Prompting: the treatment effect of the example group is obvious, the total effective rate of the example 3-6 groups is high in Yu Xiti ligustrazine group, and the treatment effect of the example 6 group is optimal.

In conclusion, the traditional Chinese medicine heat requesting and dampness eliminating ointment can improve itching, exudation and skin damage of patients, the total effective rate of the groups of the examples 3-6 is obviously higher than that of the cetirizine group, and the group of the example 6 is more obvious, so that the ointment is an effective medicament for treating eczema.

While embodiments of the present invention have been shown and described above, it will be understood that the above embodiments are illustrative and not to be construed as limiting the invention, and that variations, modifications, alternatives and variations may be made to the above embodiments by one of ordinary skill in the art within the scope of the invention.

Claims

1. A traditional Chinese medicine ointment for clearing heat and drying dampness is characterized in that: the raw materials comprise the following components in parts by weight: 12 parts of amur corktree bark, 12 parts of lightyellow sophora root, 12 parts of glabrous greenbrier rhizome, 10 parts of raw largehead atractylodes rhizome, 10 parts of Indian buead, 10 parts of dittany bark, 10 parts of belvedere fruit, 8 parts of divaricate saposhnikovia root, 8 parts of cicada slough, 10 parts of swordlike atractylodes rhizome, 12 parts of raw coix seed, 8 parts of talcum, 10 parts of bitter orange, 8 parts of tangerine peel, 6 parts of liquoric root, 6 parts of donkey-hide gelatin and 40 parts of honey.

2. The preparation method of the traditional Chinese medicine heat-clearing and dampness-eliminating paste according to claim 1, comprising the following steps:

1) Soaking the medicine: soaking cortex Phellodendri, radix Sophorae Flavescentis, rhizoma Smilacis Glabrae, rhizoma Atractylodis Macrocephalae, poria, cortex Dictamni Radicis, kochiae fructus, radix Saposhnikoviae, periostracum Cicadae, rhizoma Atractylodis, radix Coicis semen, pulvis Talci, fructus Aurantii, pericarpium Citri Tangerinae and radix Glycyrrhrizae in water, adding 8-10 times of water, and soaking for 1-3 hr;

2) Extracting: the method comprises the steps of adopting a pressurized decoction method, decocting the medicinal materials soaked in the step 1) twice, wherein the decoction pressure is 1-1.5kg, the decoction temperature is 100-150 ℃, the decoction time is 50-80min each time, placing the liquid medicine obtained by the two times of decoction and squeezing, cooling and precipitating, and filtering the supernatant after precipitating by a 80-100-mesh screen to obtain filtrate for later use;

3) Concentrating: heating the filtrate obtained in the step 2) at the working pressure of 0.2-0.3Mpa and the temperature of 115-124 ℃ by vapor pressure, boiling, removing surface froth, continuously stirring the liquid medicine, concentrating the liquid medicine to form thick paste-like clear paste, and taking the concentrated liquid drop from the stick to dry kraft paper until the paste drop does not spread and beads are formed;

4) And (3) collecting paste: adding honey and donkey-hide gelatin into the concentrated fluid extract in the step 3) while the fluid extract is hot, and continuously stirring at the working pressure of 0.2-0.35Mpa and the temperature of 118-125 ℃ to obtain the traditional Chinese medicine heat-clearing and dampness-eliminating paste with the relative density of 1.3-1.40.

3. The method for preparing the traditional Chinese medicine ointment for clearing heat and drying dampness, which is characterized in that: adding 9 times of water into the step 1), and soaking for 2 hours.

4. The method for preparing the traditional Chinese medicine ointment for clearing heat and drying dampness, which is characterized in that: the decoction pressure in the step 2) or 3) is 1.2kg, the decoction temperature is 120 ℃, and the decoction time is 60min each time.

5. The method for preparing the traditional Chinese medicine ointment for clearing heat and drying dampness, which is characterized in that: the working pressure of the step 4) or the step 5) is 0.3Mpa and the temperature is 120 ℃.

6. The use of the heat-clearing and dampness-eliminating Chinese medicinal paste according to claim 1 in the preparation of a medicament for treating eczema.