CN110279754B

CN110279754B - Traditional Chinese medicine granule for treating suppurative dermatosis, preparation method and application thereof

Info

Publication number: CN110279754B
Application number: CN201910616615.XA
Authority: CN
Inventors: 陈中建; 朱全刚; 谢欣辛; 潘会君; 谢韶琼; 姜文成; 张红敏; 连天雁; 李莹; 朱聪聪
Original assignee: SHANGHAI DERMATOLOGY HOSPITAL
Current assignee: SHANGHAI DERMATOLOGY HOSPITAL
Priority date: 2019-07-09
Filing date: 2019-07-09
Publication date: 2021-08-17
Anticipated expiration: 2039-07-09
Also published as: CN110279754A

Abstract

The invention relates to a traditional Chinese medicine composition for treating suppurative skin diseases, which is prepared from the following raw material medicines in parts by weight: dandelion, common andrographis herb, wild chrysanthemum flower, weeping forsythia and purslane. The invention also provides application of the composition in preparing a medicament for treating purulent dermatosis and a preparation method of the medicament. Its advantages are: 1. on the basis of the combination of dialectical and disease differentiation, the raw material medicines are selected according to the principle of 'dialectical cause seeking and cause checking and treatment' in traditional Chinese medicine, the dialectical is accurate and complete, the symptoms and root causes are treated simultaneously, and the dandelion and the forsythia are added in the formula, so that the effects of detoxifying and treating sores are achieved, the traditional Chinese medicine is used for treating carbuncles caused by heat toxin accumulation and red swelling and hot pain, and the curative effect is excellent. 2. The components of the traditional Chinese medicines and the proportion thereof are screened by experiments, and the traditional Chinese medicine has the advantage of remarkable effect. 3. The extraction and purification process is optimized, a water extraction and alcohol precipitation process is adopted, and the process parameters such as the optimal extraction temperature, the solvent adding amount, the heating time and the like are selected, so that the obtained medicine extract has high rate.

Description

Traditional Chinese medicine granule for treating suppurative dermatosis, 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 granule for treating suppurative dermatosis, a preparation method and application thereof.

Background

(ii) social development need

Suppurative dermatosis is a common disease, the incidence rate of children is higher than that of adults, rural areas are higher than that of cities, and the suppurative dermatosis accounts for about 5 percent of the skin disease. The body has no innate and permanent immunity to suppurative bacteria, so it can be infected repeatedly, and also can be infected mutually in families, kindergartens and primary schools due to contact infection, and can also cause various complications. The environment or living conditions are poor, people cannot take a bath and change clothes in time, and the wounds, the insect bites and other places are easy to cause diseases. The common diseases include acne, impetigo, folliculitis, furuncle, carbuncle, erysipelas, etc.

Acne, called "lung wind acne", "wine acne", "wind acne" and "comedo" in traditional Chinese medicine, is mostly seen in young people, more men than women, and the damage is better in the greasy areas of cheek, forehead, chin, nasal and buccal sulcus, and then chest, back and shoulder. Initially small papules and pustules, with increased inflammation, large small pustules from rice to pea appearing on the tips of the papules, which break or absorb and leave temporary pigmentation or small crater-like scars. When the inflammation continues to expand and deepen, pale red or dark red nodules of different sizes or slightly higher than the surface of the skin are formed under the skin. Such lesions may be present for a longer period of time, or may be absorbed gradually, or may form scars after suppuration and rupture. Modern medicine considers that acne is a chronic inflammatory skin disease which invades hair follicles and sebaceous gland units, and the pathogenesis is not completely clarified. Genetic, androgen-induced sebum secretion in large quantities, pilosebaceous duct keratosis, proliferation of Propionibacterium acnes and aerobic staphylococci, inflammation and immune response may be associated with these factors. The disease is on the rise with the pace of life acceleration, pressure increase, and environmental pollution.

Impetigo is commonly called "impetigo", a bacterial infectious skin disease that is well developed in children, and patients easily spread the infection to themselves or others by scratching the infected site, clinically impetigo pustulosa, impetigo nonpepticus, and staphylococcal scalded skin syndrome. The main pathogenic bacteria is staphylococcus aureus, and the second is group A beta hemolytic streptococcus and the mixed infection of the two. The treatment of impetigo mainly comprises topical antibiotics and oral antibiotics and systemic medication.

Folliculitis, a suppurative inflammation caused by bacterial infection of hair follicles, is mainly caused by coagulase-positive staphylococcus aureus, and secondly staphylococcus albus. It is often found on the head, face, limbs, perineum, etc. Initially, the papules are large and follicular papules with papules, gradually form pustules, and appear in batches without fusion. A small amount of purulent blood can be discharged after the pustule is broken, and no pustule is produced. The pustule can be absorbed in 4-5 days, usually without scar, but easy to recur, and can last for several months. It is better for young and middle-aged people, and is common for men in China, the ratio of men to women is 2.2: 1, and the average age is about 30 years old. May be related to more sweating caused by vigorous metabolism and more exercise of young people; in addition, the incidence rate is high in summer, which suggests that high temperature, sweating, dampness and the like are important factors for inducing or aggravating folliculitis.

(II) Current situation, level and development trend at home and abroad

1. Western medicine treatment of suppurative skin diseases:

modern medicine considers that the pathogenesis of the traditional Chinese medicine is related to factors such as endocrine, follicular sebaceous gland duct keratosis, microbial infection, immunity, heredity and the like, and in addition, improper use of cosmetics, excessive mental stress, tobacco, wine, spicy, sweet and greasy food and the like can be aggravation or promotion factors.

(1) Local treatment: the principle is cleaning, anti-inflammatory, drying, astringing, and preventing diffusion.

Firstly, the non-ulcerated erythema, papule and pimple can be applied with antibacterial drugs such as 1% lincomycin gel, 10% sodium sulfacetamide solution, 0.5% neomycin ointment or 2% mupirocin ointment, 0.5% erythromycin ointment, 3% ciprofloxacin ointment, 1% povidone ointment, etc.;

secondly, puncturing larger pustules by using a sterile needle, completely sucking pus by using a sterile dry cotton ball to prevent the pus from overflowing to normal skin, and then using the external preparation;

thirdly, wet dressing is preferred for exudation, erosion and incrustation skin lesions, and wet dressing should be carried out for several times for patients with wide area to prevent drug absorption and poisoning.

(2) Systemic treatment: doxycycline and minocycline are commonly used for treating acne by oral administration. Impetigo herpetifomis commonly used is oral, intramuscular or intravenous drip of broad-spectrum semi-synthetic penicillins resistant to penicillinase, such as amoxicillin, methicillin; for people with penicillin allergy, quinolone (cautious for children), macrolide such as erythromycin, azithromycin or cephalosporin antibiotics can be selected. Appropriate antibiotics such as sulfonamides, penicillins, cephalosporins or gentamicin should be selected for folliculitis; hormones such as itraconazole, ketoconazole, and the like.

(3) Physical therapy: ultraviolet ray and ultrashort wave irradiation.

Although western medicine adopts various treatment methods for suppurative dermatosis, great effect is achieved, for example, in the conventional treatment of acne, anti-keratotic drugs are often adopted to promote the normal keratosis of hair follicle epithelium, antibiotics and hormone drugs are often used to kill bacteria in hair follicles, reduce the amount of free fatty acid and relieve inflammatory reaction, western medicine treatment also faces some problems, such as drug resistance of bacteria, easy recurrence, long treatment course, high cost and the like. Over the past 25 years, the resistance of acne bacilli to antibiotics has increased dramatically, reaching 62% in the uk, and has become an international problem.

2. The traditional Chinese medicine treatment of the suppurative dermatosis comprises the following steps:

(1) the theory of traditional Chinese medicine: the traditional Chinese medicine considers that the suppurative dermatosis is mainly caused by unsmooth qi movement, abnormal catharsis and fumigation of the skin due to summer-heat, damp and toxic heat. Summer-heat is a yang pathogen, and is characterized by itching due to slight heat, pain due to extreme heat, and rotten meat due to excessive heat, manifested as abscess, burning, rotting and fluid-nourishing of the affected part. Pathogenic fire-heat tends to enter the blood system and gather locally, corroding blood and growing into carbuncle, swelling and sores. Excessive summer-heat can cause fever, thirst, dry stool, dark urine, etc.; summer-heat usually involving dampness, dampness being heavy, turbid, sticky and greasy, is liable to cause blister erosion, invasion of pathogenic fluid into the body, and dribbling of pathogenic fluid. Therefore, the pathogenesis of the diseases should be grasped, and the treatment should be carried out according to the disease condition and the development characteristics of the skin lesions, and the treatment should be carried out based on syndrome differentiation, and the effects of clearing heat, purging fire, removing toxicity, and clearing damp-heat are achieved. The meaning of "poison" in TCM is very broad, and besides heat poison and fire poison caused by fire-heat asphyxia, it is also called poison for some external pathogenic factors such as bacteria, viruses, parasites, etc. As a specific treatment means in China, the traditional Chinese medicine accumulates abundant experience in the long-term clinical treatment practical process and shows unique advantages. Under the condition that the antibiotic resistance is getting more and more serious, the application of traditional Chinese medicine in treating the infectious skin diseases is considered to be necessary. Clinically, many infectious skin diseases such as acne, folliculitis, impetigo and other suppurative skin diseases are usually distinguished as heat-toxin syndrome. The heat-clearing and detoxifying method is a commonly used method for treating heat-toxicity diseases, and has long history, rich experience and obvious curative effect in treating infectious diseases such as furuncle, carbuncle, sore and pyogenic infections by matching the heat-clearing and detoxifying method with other therapies. Therefore, the medicines for clearing away heat and toxic materials and strengthening body resistance, such as honeysuckle, forsythia, dandelion, wild chrysanthemum flower, coptis, scutellaria, phellodendron, gardenia, bunge corydalis herb and the like, can be used for treating acne, folliculitis, pyogenic bacterial skin diseases and related skin diseases.

(2) The action mechanism of the traditional Chinese medicine is as follows: in recent years, with the development of traditional Chinese medicine pharmacological research, the research on the effect of traditional Chinese medicines on suppurative skin diseases such as acne, folliculitis, impetigo and the like is greatly advanced, the pharmacological action mechanism of the traditional Chinese medicines for clearing heat and removing toxicity is gradually disclosed, the research target of the traditional Chinese medicines for treating the traditional pyretic diseases is combined with the pathogenesis of western medicines from the single improvement of clinical symptoms in the past to the attention of recent years, and the effectiveness of the traditional Chinese medicines for treating the suppurative skin diseases is objectively proved by taking the effects of resisting the keratosis of follicular sebaceous gland ducts, resisting bacteria, resisting inflammation, regulating immunity, regulating sex hormone activity and the like as evaluation indexes. For example, the research on the mechanisms of resisting bacteria and inflammation, promoting immunity and the like of a single Chinese medicinal extract has been reported. The isatis root water extract has an inhibiting effect on 10 bacteria such as staphylococcus aureus, diplococcus pneumoniae, bacillus influenzae, diplococcus meningitidis and the like; its different extraction sites can inhibit acute inflammatory reaction caused by xylene. The andrographis paniculata extract has strong bacteriostatic power on coagulase-negative staphylococcus. The andrographolide, the main active ingredient of andrographis paniculata, has strong antibacterial activity on bacillus subtilis, escherichia coli, staphylococcus aureus and the like, and also has the effects of promoting the proliferation of immunocompetent cells, increasing the phagocytosis and the migration index of macrophages, improving the proportion of CD3 and CD4.CD8 cells and increasing the immune function. The extraction part of the forsythia suspense macroporous resin has certain antagonism on mouse ear swelling caused by xylene or croton oil and rabbit fever caused by endotoxin; the volatile oil, chromatography volatile oil and beta-pinene in forsythia fruit have the inhibition effect on 10 strains of colibacillus, staphylococcus aureus, pneumococcus, haemophilus influenzae, etc. in vitro. The purslane has a strong inhibiting effect on various common food contamination bacteria such as escherichia coli, salmonella, shigella, staphylococcus aureus and the like, wherein flavonoids are probably the most main bacteriostatic components in the purslane; the purslane alcohol extract has antagonistic action on mouse auricle swelling caused by dimethylbenzene or croton oil, can obviously reduce the contents of TNF-alpha and IL-4 (p is less than 0.05) in skin tissues of acute eczema rats, and has obvious curative effect on eczema skin. The dandelion ethanol extract can partially inhibit the spatholobus spathula swelling caused by carrageenan and has certain inhibition effect on the ear swelling caused by xylene; the dandelion has broad-spectrum antibacterial effect, and the extracts of different parts have different degrees of inhibition effects on gram-positive bacteria, gram-negative bacteria, fungi, spirochetes and viruses. The mechanism of inhibition of staphylococcus aureus may be related to affecting the biofilm and the amount of eDNA released from staphylococcus. The mother chrysanthemum extract stock solution has certain inhibiting effect on staphylococcus aureus, escherichia coli and the like, and the action mechanism is different from midecamycin; the wild chrysanthemum flower decoction and the active ingredients can inhibit the mouse auricle swelling caused by dimethylbenzene and the mouse abdominal cavity capillary permeability increase caused by acetic acid. Some traditional Chinese medicine formulas and Chinese patent medicines can obviously reduce the permeability of capillary vessels, and have inhibitory effect on common pathogenic bacteria of common acne, staphylococcus aureus, staphylococcus epidermidis and propionibacterium acnes, for example, the keratosis of the hair follicle of a patient is reduced after the traditional Chinese medicine formulas are used for treatment. In addition, some traditional Chinese medicines and formulas have certain effects on immunoregulation, and Wu Xiaohong and the like find that the snake Dan mixture (oldenlandia diffusa, salvia miltiorrhiza, scutellaria baicalensis, selfheal and the like) can obviously change lg-G and IL-2 (P is less than 0.01 and P is less than 0.05) in peripheral blood of acne patients, and the regulation effect of the mixture on cellular and humoral immunity is supposed to be one of the mechanisms of clinical treatment. Researches on campsis grandiflora and the like find that the heat-clearing acne soup (wild chrysanthemum, dandelion, Chinese violet, honeysuckle, giant knotweed and the like) can obviously inhibit delayed hypersensitivity and inflammatory reaction, can obviously reduce T lymphocyte subsets of peripheral spleen and organ indexes of immune organs, and has exact anti-inflammatory effect. In addition, researches show that various traditional Chinese medicine monomer components have antibacterial and anti-inflammatory effects, for example, the traditional Chinese medicine monomer components have a better in-vitro antibacterial effect on propionibacterium acnes, tanshinone can reduce sebum secretion of acne patients, and the traditional Chinese medicine monomer components have a definite curative effect on female delayed acne. The free anthraquinone of rhubarb has strong in-vitro inhibition effect on main pathogenic bacteria of acne.

(3) Clinical application

For thousands of years, Chinese nation can thrive and prosperous by virtue of the characteristic advantages of 'simple and cheap' traditional Chinese medicine. Therefore, the twelve-five-period countries inject a great amount of manpower and financial resources into the research and development of Chinese medicines. The Chinese preparation in the traditional Chinese medicine research and development process is always the key point of the national investment because of being widely used clinically. However, in clinical application, clinical research on a single traditional Chinese medicine is few, and a traditional Chinese medicine clinical multi-purpose compound is more consistent with the theory of traditional Chinese medicine, but a scheme with strong feasibility is few, and most of the schemes stay in the animal experiment stage. Although some studies have conducted clinical trials, most of the studies mainly use decoction, which is inconvenient for long-term administration, and thus the popularization of the decoction is affected. Moreover, a part of the prescription forms more expensive medicines, and the economic burden is large after long-term taking.

In addition, the preparation method of the medicine in the prior art has certain defects: low extract rate, uneven medicine, easy caking, high manufacturing cost, complex preparation method and the like.

Aiming at the defects of the prior art, the inventor researches the traditional Chinese medicine granule for treating the suppurative dermatosis, optimizes the preparation method, and proves that: the medicine extract obtained by the preparation method has high rate and good curative effect; the traditional Chinese medicine composition and the proportion thereof are optimal selection, and the treatment efficiency is high.

Disclosure of Invention

The first purpose of the invention is to provide a traditional Chinese medicine composition for treating suppurative skin diseases, which aims at overcoming the defects of the prior art.

The second purpose of the present invention is to provide the use of the above traditional Chinese medicine composition to overcome the defects of the prior art.

The third purpose of the invention is to provide a traditional Chinese medicine granule for treating suppurative skin diseases, which aims at overcoming the defects of the prior art.

The fourth purpose of the present invention is to provide a preparation method of the above traditional Chinese medicine granule for treating purulent skin diseases, which aims at overcoming the defects of the prior art.

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

a traditional Chinese medicine composition for treating suppurative dermatosis is prepared from the following raw material medicines in parts by weight: dandelion, common andrographis herb, wild chrysanthemum flower, weeping forsythia and purslane.

As a preferred embodiment of the invention, the Chinese medicinal preparation is prepared into a clinically acceptable medicinal preparation according to a conventional Chinese medicinal preparation method.

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

the application of the traditional Chinese medicine composition in preparing a medicine for treating purulent skin diseases.

As a preferred embodiment of the present invention, the suppurative skin disease is acne, impetigo, folliculitis, furuncle, carbuncle, erysipelas.

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

a traditional Chinese medicine granule for treating purulent skin diseases is prepared from the traditional Chinese medicine composition, and the preparation method of the granule comprises the following steps:

(1) water extraction is carried out twice: weighing the following raw material medicines in parts by weight: the water adding amount of dandelion, common andrographis herb, wild chrysanthemum, weeping forsythia and purslane is 8 times of the total weight of the raw material medicines each time, the raw material medicines are decocted for 2 times and each time lasts for 2 hours, decoction liquid is merged and filtered to obtain filtrate;

(2) alcohol precipitation: concentrating the filtrate obtained in step (1) under reduced pressure until the density of the extract is 1.2, slowly adding 95% ethanol until the alcohol concentration is 70%, standing overnight, concentrating the filtrate under reduced pressure until no alcohol smell exists, and continuously concentrating to obtain fluid extract with relative density of 1.10;

(3) adding auxiliary materials into the extract obtained in the step (2), wherein the auxiliary materials comprise dextrin in parts by weight: and (3) uniformly mixing lactose and lactose, adding 10% of vinylpyrrolidone K30-95% ethanol solution, granulating, and vacuum drying to obtain the lactose-milk powder.

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

a preparation method of traditional Chinese medicine granules for treating suppurative dermatosis comprises a water extraction and alcohol precipitation method; the method comprises the following steps:

As a preferred embodiment of the present invention, the step (3) method comprises:

a, putting the extract obtained in the step (2) into a granulating pot, adding dextrin, mixing for 10 minutes at the speed of 300rpm of main stirring and 500rpm of a cutting knife, and stopping stirring to obtain a first semi-finished product;

b, adding lactose into the first semi-finished product obtained in the step a, mixing for 10 minutes at the speed of 300rpm of main stirring and 500rpm of a cutting knife, and stopping stirring to obtain a second semi-finished product;

c, adding PVPK30-95% ethanol slurry into the second semi-finished product obtained in the step b under the conditions of main stirring speed of 300rpm and cutting speed of 1500rpm of a cutter, sieving with a 14-mesh sieve, carrying out wet granulation, and carrying out vacuum drying at 60 ℃ to obtain the finished product.

As a preferred embodiment of the present invention, the method further comprises thin layer chromatography identification.

Square solution:

dandelion and forsythia fruit: dandelion is cool in nature and can be applied for all kinds of diseases such as furuncle, carbuncle and ulcer, and red swelling and heat toxin, which is very effective in treating acute mastitis, furuncle, and red swelling and mass. The fresh one should be pounded into juice and taken warmly, while the dry one should be decocted, which is indispensable for the prescription of decoction. "Lian Qiao" is a key herb for sores because it can ascend, float, disperse and disperse, circulate qi and blood, and treat the accumulation of qi in blood of twelve meridians. It can penetrate the muscles and relieve exterior syndrome, clear heat and dispel wind, and is also the key herb for wind-heat. Besides, it can expel toxin and is an essential herb for treating eruption. The prescription uses dandelion and forsythia, and forsythia removes toxin, eliminates stagnation and eliminates carbuncle; dandelion is bitter and cold in flavor, and can clear away heat and toxic material. The compatibility of two herbs has the efficacy of removing toxicity and treating sores, and is used for treating acute mastitis with red swelling and hot pain due to accumulated heat-toxin, which is the monarch drug of the formula. Wild chrysanthemum flower: clearing away heat and toxic material, purging fire and calming the liver, and can be used for treating carbuncle, swelling, sore and ulcer, conjunctival congestion, swelling and pain, headache and vertigo. The dandelion is matched with the chrysanthemum and the dandelion to clear away heat and toxic materials; chrysanthemum flower has effects of calming liver and improving eyesight. The combination of the two has the effects of removing toxicity and improving eyesight, and can be used for treating conjunctival congestion and swelling pain caused by wind-heat attack. Therefore, the traditional Chinese medicine is a ministerial and auxiliary part of the recipe. Andrographis paniculata, purslane: andrographis paniculata Nees has the effects of clearing away heat and toxic materials, relieving inflammation and relieving swelling. It is indicated for laryngopharyngitis, dysentery and high fever. "Ma Chi Xian is pungent and cold in property and can cool blood and dispel heat, so it is indicated for mass, abscess, sore, furuncle, alopecia areata and thirty-six kinds of wind-induced sores, and when pounded, it will be swollen, furuncle and root-removed, and when squeezed, it will appear immediately and applied both internally and externally. Being pungent and cold with the effect of relieving the cold and heat, it is also convenient in size. Is an adjuvant drug of the recipe. In conclusion, the recipe has the functions of clearing away heat and toxic material, removing carbuncle and dissipating nodulation, and can be used for treating purulent skin diseases such as impetigo herpetifomis, folliculitis and the like. All the medicines are orderly in major and minor, have clear levels and accord with the formula principle of the traditional Chinese medicine formulation.

In the formula, the dandelion and the forsythia are added, so that the effects of detoxifying and sore healing are achieved, and the traditional Chinese medicine is used for treating carbuncle caused by heat toxin accumulation with red swelling and hot pain, and has a more comprehensive curative effect.

The invention has the advantages that:

1. strict prescription, treatment based on the principle of treatment

The suppurative dermatosis is considered by the traditional Chinese medicine dialectical theory and belongs to the category of heat toxicity, clinical differentiation is mainly attributed to retention of damp-heat in the interior, accumulation of skin, heat generated due to long-term stasis and pus formation due to excessive heat, and medicines for clearing heat and removing toxicity, dispelling wind and removing dampness are mostly adopted in treatment. The prescription is prepared according to the principle of 'dialectical cause seeking and cause treatment' of traditional Chinese medicine based on the combination of dialectical and disease differentiation, the whole formula is totally five traditional Chinese medicines, the compatibility principle of 'monarch, minister, assistant and guide' is met, a plurality of symptoms such as red, swelling, pain, heat, dysfunction and the like can be obviously improved, erosion sore pustules are scabbed on the surface, new skin cannot be damaged after scabs fall off, the prescription has certain effects of resisting bacteria, resisting inflammation, improving immunity and the like, the curative effect is exact, no adverse reaction exists in the clinical use process, and a good development foundation is provided.

2. Through a pharmacodynamic test, the extraction and purification process is optimized, and key parameters of the process procedures such as complete extraction, concentration, drying, preparation forming and the like are included, so that the effective components are extracted to the maximum extent.

3. The components of the traditional Chinese medicines and the proportions thereof are screened through experiments, so that the traditional Chinese medicine has the advantage of remarkable effect, relieves the pain of patients, and improves the life quality of the patients; in addition, the preparation method and each process parameter are optimized, and effective components are extracted to the maximum extent; in addition, in the preparation process, water and medical alcohol are mainly selected, wherein the alcohol can be recycled, the wastewater is treated by a sewage treatment system and then discharged after reaching the standard, no influence on the environment is caused, and the preparation method can be industrialized, can be produced in batch, has strong practicability and can be well applied to clinic.

Drawings

FIG. 1 is a diagram showing the thin-layer identification result of Andrographis paniculata Nees according to the present invention, wherein (1) is a negative control; (2) a test article; (3) a standard substance; (4) and (5) comparison medicinal materials.

FIG. 2 is a diagram showing the results of thin layer identification of dandelion in the present invention, wherein (1) negative control; (2) reference medicinal materials; (3) a test article 1; (4) sample 2.

FIG. 3 is a diagram showing the thin-layer identification result of Forsythia suspensa in the prescription, wherein (1) the standard substance; (2) reference medicinal materials; (3) a test article; (4) and (5) a negative control product.

FIG. 4 is a chromatogram result chart in which A. phillyrin control solution B. test sample solution C. negative control solution.

FIG. 5 is a linear calibration curve (AS-Vol).

FIG. 6 is a HE staining pattern, HE, X20, of the pathological morphology of tumor skin in the blank control group.

FIG. 7 is a HE staining pattern, HE, X100, of the pathological morphology of tumor skin in the placebo group.

FIG. 8 is a graph of HE staining, HE, X20, of the pathological morphology of tumor skin in the model group.

FIG. 9 is a HE staining pattern, HE, X100, of the pathological morphology of tumor skin in the model group.

FIG. 10 is a HE staining pattern, HE, X20, of the skin pathological morphology of a Schiff's acid-group tumor.

FIG. 11 is a HE staining pattern, HE, X100, of the skin pathological morphology of a Schiff's acid-group tumor.

FIG. 12 is HE staining pattern, HE, X20 of low-dose mass of herbal extracts.

FIG. 13 is HE staining pattern, HE, X100 of low-dose mass of herbal extract.

FIG. 14 shows HE staining pattern, HE, X20 of pathological morphology of tumor skin in the Chinese medicinal composition extract.

FIG. 15 shows HE staining pattern, HE, X100 of pathological morphology of tumor skin in Chinese medicinal composition extract.

FIG. 16 is HE staining pattern, HE, X20 of high-dose mass of herbal extract.

FIG. 17 is HE staining pattern, HE, X100 of high-dose mass of herbal extract.

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 1A Chinese medicinal composition for treating suppurative dermatoses

Taking the following raw material medicines in parts by weight: dandelion, common andrographis herb, wild chrysanthemum flower, weeping forsythia and purslane.

Example 2A Chinese medicinal composition for treating suppurative dermatoses

Taking the following raw material medicines in parts by weight: 1 part of dandelion, 2 parts of common andrographis herb, 3 parts of wild chrysanthemum flower, 4 parts of weeping forsythia and 5 parts of purslane.

Example 3A Chinese medicinal composition for treating suppurative dermatoses

Taking the following raw material medicines in parts by weight: 0.5 part of dandelion, 1 part of common andrographis herb, 1.5 parts of wild chrysanthemum flower, 2 parts of weeping forsythia and 2.5 parts of purslane.

Example 4A Chinese medicinal composition for treating purulent skin diseases

Taking the following raw material medicines in parts by weight: 1 part of dandelion, 2 parts of common andrographis herb, 1.5 parts of wild chrysanthemum flower, 2.5 parts of weeping forsythia capsule and 2 parts of purslane.

Example 5A Chinese medicinal granule for treating suppurative dermatoses

The preparation method comprises the following steps:

(1) water extraction is carried out twice: weighing the following raw material medicines: 5 parts of dandelion, 5 parts of common andrographis herb, 5 parts of wild chrysanthemum flower, 5 parts of weeping forsythia capsule and 5 parts of purslane, wherein the water adding amount is 8 times of the total weight of the raw material medicines each time, the decoction is carried out for 2 times and 2 hours each time, the decoction is combined, and the filtrate is obtained by filtration;

(3) putting the extract obtained in the step (2) into a granulating pot, adding 3 parts of dextrin, mixing for 10 minutes at the speed of 300rpm of main stirring and 500rpm of a cutting knife, and stopping stirring to obtain a first semi-finished product;

adding 2 parts of lactose into the first semi-finished product, mixing for 10 minutes at the speed of 300rpm of main stirring and 500rpm of a cutting knife, and stopping stirring to obtain a second semi-finished product;

adding PVPK30-95% ethanol slurry into the second semi-finished product under the conditions of main stirring speed of 300rpm and cutting speed of 1500rpm, sieving with 14 mesh sieve, wet grading, and vacuum drying at 60 deg.C to obtain the final product.

Example 6A Chinese medicinal granule for treating suppurative dermatoses

The preparation method comprises the following steps:

(1) water extraction is carried out twice: weighing the following raw material medicines: 5 parts of dandelion, 5 parts of common andrographis herb, 5 parts of wild chrysanthemum flower, 5 parts of weeping forsythia and 5 parts of purslane, wherein the water adding amount is 10 times of the total weight of the raw material medicines each time, the decoction is carried out for 1 time, the decoction time is 1 hour, the decoction liquids are combined, and the filtrate is obtained by filtration;

(2) alcohol precipitation: concentrating the filtrate obtained in step (1) under reduced pressure until the density of the extract is 1.8, slowly adding 85% ethanol until the alcohol concentration is 80%, standing overnight, concentrating the filtrate under reduced pressure until no alcohol smell exists, and continuously concentrating to obtain fluid extract with relative density of 1.50;

(3) putting the extract obtained in the step (2) into a granulating pot, adding 3 parts of dextrin, mixing for 8 minutes at the speed of 500rpm of main stirring and 800rpm of a cutting knife, and stopping stirring to obtain a first semi-finished product;

adding 2 parts of lactose into the first semi-finished product, mixing for 8 minutes at the speed of 500rpm of main stirring and 800rpm of a cutting knife, and stopping stirring to obtain a second semi-finished product;

adding PVPK 30-85% ethanol slurry into the second semi-finished product under the conditions of main stirring speed of 500rpm and cutting speed of 2000rpm, sieving with 14 mesh sieve, wet grading, and vacuum drying at 60 deg.C to obtain the final product.

Example 7A Chinese medicinal granule for treating suppurative dermatoses

The preparation method comprises the following steps:

(1) water extraction is carried out twice: weighing the following raw material medicines: 5 parts of dandelion, 10 parts of common andrographis herb, 15 parts of wild chrysanthemum flower, 12.5 parts of forsythia and 25 parts of purslane, wherein the water adding amount is 10 times of the total weight of the raw material medicines each time, the decoction is carried out for 1 time, the decoction time is 1 hour, the decoction liquids are combined and filtered to obtain filtrate;

adding 3 parts of lactose into the first semi-finished product, mixing for 15 minutes at the speed of 300rpm of main stirring and 500rpm of a cutting knife, and stopping stirring to obtain a second semi-finished product;

adding PVPK 30-80% ethanol slurry into the second semi-finished product under the conditions of main stirring speed of 500rpm and cutting speed of 2000rpm, sieving with 14 mesh sieve, wet grading, and vacuum drying at 60 deg.C to obtain the final product.

Example 8A decoction for the treatment of purulent skin diseases

The preparation method comprises the following steps:

taking the following raw material medicines in parts by weight: the water adding amount of the dandelion, the common andrographis herb, the wild chrysanthemum, the weeping forsythia and the purslane is 8 times of the total weight of the raw material medicines, the decoction is carried out for 2 times, the time of each decoction is 2 hours, the filtration is carried out, and the two decoctions are combined.

Example 9A Capsule/Capsule for treating suppurative dermatoses

The preparation method comprises the following steps:

taking the following raw material medicines in parts by weight: adding 8 times of water into dandelion, common andrographis herb, wild chrysanthemum flower, weeping forsythia and purslane, boiling with strong fire, and decocting with small fire for 2 hours; filtering, concentrating the filtrate, and cooling to room temperature; taking supernatant, and concentrating to obtain thick extract; adding pharmaceutical adjuvants, vacuum drying, pulverizing, granulating, and making into tablet or capsule. The whole preparation process is decocted only once.

EXAMPLE 10 screening of the preparation Process

1 dosage form selection

To further explore the optimum extraction process, this study is intended to pass the efficacy test, and to perform a preliminary screening of the extraction vehicle and process. And the screened extraction method is systematically optimized, so that the extract exerts more excellent curative effect.

2 Experimental materials and instruments

TABLE 1 Experimental materials

TABLE 2 Experimental instruments

3 study of extraction Process

3.1 selection of extraction method

The medicine is a compound preparation consisting of 5 traditional Chinese medicines, and has more complex components. The traditional Chinese medicinal materials in the prescription only contain more volatile components, and most of the traditional Chinese medicinal materials contain flavone, terpenoids, organic acid and other components, so that different extraction solvents are selected for extracting the effective components to the maximum extent, the obtained extract is subjected to drug effect screening, and a proper extraction method is selected according to the drug effect result. The method comprises the following steps:

(1) extracting with 80% ethanol: taking 100g of the medicinal materials, adding 80% ethanol, extracting for 1L, heating and refluxing for 2 hours, filtering, adding 800mL of 80% ethanol into filter residues, heating and refluxing for 2 hours, filtering, combining filtrates, recovering ethanol under reduced pressure, and evaporating to dryness to obtain an extract, wherein the batch number is 20170521.

(2) Extracting with 30% ethanol: taking 100g of the medicinal materials, adding 30% ethanol for extracting 1L, heating and refluxing for 2 hours, filtering, adding 800mL of 30% ethanol into filter residues, heating and refluxing for 2 hours, filtering, combining filtrates, recovering ethanol under reduced pressure, and evaporating to dryness to obtain an extract, wherein the batch number is 20170522.

(3) Water extraction: collecting 1000g total medicinal materials, adding water 1L, decocting for 2 hr, filtering, adding water 800mL into residue, decocting for 2 hr, filtering, mixing filtrates, concentrating under reduced pressure to obtain extract with density of 1.2, and evaporating to obtain extract, with batch number 20170523.

(4) Water extraction and alcohol precipitation: taking 100g of the medicinal materials in total, adding 1L of water, decocting for 2 hours, filtering, adding 800mL of water into filter residues, decocting for 2 hours, filtering, combining the filtrates, concentrating under reduced pressure until the density of the extract is 1.2, slowly adding 95% ethanol until the alcohol concentration is 70%, standing overnight, concentrating the filtrate under reduced pressure, recovering, and evaporating to dryness to obtain the extract, wherein the batch number is 20170524.

The results of the above 4 extraction methods are shown in Table 3.1 below.

TABLE 3.1 results of four different extraction methods

The 4 samples were subjected to drug effect screening, and the antibacterial effect of each sample was observed by administering 1g/g in the low dose group and 5g/g in the high dose group.

TABLE 3.2 antimicrobial Effect results a for four samples at different dosages

a antibacterial ring size (mm)

The results in table 3.2 show that the samples extracted by the four methods have no obvious bacteriostatic action on escherichia coli, pseudomonas aeruginosa and candida albicans, and have bacteriostatic action on staphylococcus aureus, wherein the dry extract prepared by the water extraction and alcohol precipitation process has the best bacteriostatic action and the best drug effect on staphylococcus aureus, so the water extraction and alcohol precipitation method is adopted in the extraction process.

To select the best extraction process, an orthogonal test was performed on the process. Because the water extraction and alcohol precipitation process is carried out in two stages, and the influence factors of the two stages are different, orthogonal tests are respectively carried out on the water extraction step and the alcohol precipitation step.

3.2 Water extraction Process Quadrature test

The 3 factors which have great influence on the yield of the water extract are selected as the investigation factors of the orthogonal experiment for orthogonal experiment design, and the extraction times, the extraction time and the water addition amount are shown in the table 3.3.

TABLE 3.3 Water extraction Process orthogonal optimization experiment factor horizon

By L₉(3³) Orthogonal tables are designed to optimize the water extraction process, and the specific experimental arrangement is shown in table 3.4.

TABLE 3.4 Water extraction orthogonal Experimental Table

TABLE 3.5 range analysis of Water extraction Process Quadrature experiments

The horizontal orthogonal test is carried out according to the table 3.5, the comprehensive score of the sum of the extract yield score and the phillyrin content score is respectively taken as a survey index to carry out range analysis on the orthogonal test, and the data are shown in the table 3.5. As can be seen from the above table, the optimal level experimental group A can be found by comparing the results of the above experiments within the same factor₂B₂C₁(ii) a According to the magnitude of the range R value, the primary and secondary sequence of the factors influencing the comprehensive score is as follows: b (extraction time)>A (number of extractions)>C (water addition). Thus selecting A₂B₂C₁The factor level is taken as the extraction process of the solution, namely the optimal water extraction process is determined as follows: extracting for 2 times, each for 2 hr, and adding 8 times of water.

3.3 verification of optimal conditions for Water extraction experiments

The total amount of the five prescription medicinal materials in three parts is 100g, and the test is carried out according to the optimal extraction process, and the verification result is shown in table 3.6.

TABLE 3.6 Water extraction Process validation test results

In the three experiments, the relative standard deviation RSD of the average content of the phillyrin in the extract is 1.19 percent <3 percent, and the optimal extraction process is stable and reliable within the required range, and is determined to be the optimal extraction process of the traditional Chinese medicine granule water extraction.

3.4 alcohol precipitation Process Quadrature test

And after the water extraction process is determined, carrying out orthogonal test on the alcohol precipitation process, and selecting the optimal alcohol precipitation process. The 3 factors with large influence on the phillyrin content, namely the ethanol concentration (V/V), the standing time during alcohol precipitation and the relative density of the concentrated extract, are selected as the investigation factors of the orthogonal experiment to carry out orthogonal experiment design, and the factors are shown in table 3.7.

TABLE 3.7 level chart of orthogonal optimization experiment factors of alcohol precipitation process

By L₉(3³) An alcohol precipitation process optimization experiment is designed on an orthogonal table, and the specific experimental arrangement is shown in table 3.8.

TABLE 3.8 alcohol precipitation orthogonal experiments Table

TABLE 3.9 worst analysis of orthogonal experiments for alcohol precipitation process

The test is carried out according to the table 3.8, samples No. 1-9 are obtained, the comprehensive score of the sum of the extract yield score and the phillyrin content score is taken as a survey index, and the data is shown in the table 3.9. According to the magnitude of the range R value, the primary and secondary sequence of the factors influencing the comprehensive score is as follows: b (extract density)>A (ethanol concentration)>C (standing time). Thus selecting A₂B₃C₃The factor level is used as the alcohol precipitation process of the solution, namely the optimal alcohol precipitation process is determined as follows: concentrating the extractive solution to density of 1.1, precipitating with ethanol to concentration of 70%, and standing for 24 hr.

3.5 verification of optimal conditions of alcohol precipitation experiment

The total 50g of the five prescription medicinal materials in three parts are weighed, the test is carried out according to the optimal alcohol precipitation process, and the verification result is shown in the table 3.10.

TABLE 3.10 verification of alcohol precipitation Process

In the three experiments, the relative standard deviation RSD of the phillyrin content in the dry extract is 0.94% < 3%, and in the required range, the optimal extraction process is stable and reliable, and the process is determined to be the optimal alcohol precipitation process of the traditional Chinese medicine particles. The screened alcohol precipitation process conditions are basically stable.

3.6 study of drying Process

Hot air circulation drying and vacuum drying are common drying methods for Chinese medicinal extract, and the drying methods are screened by comparing drying efficiency and yield.

Taking extracts of 2 batches (20170711, 20170712) in the alcohol precipitation verification test, and inspecting by different drying methods.

TABLE 3.11 drying Process Experimental results

The experimental results are shown in Table 3.11, the loss amount of vacuum drying water is small, the drying time is moderate, and the water content is easy to control, so the drying method of the product is vacuum drying.

4 preparation Process study

The clinical dosage of the traditional Chinese medicine is 50g of crude drug per day, if the extract yield is 10%, the dosage of dry extract is about 5g per time, so that granules with large drug-loading rate are selected as the dosage form of the traditional Chinese medicine.

4.1 prescription screening study

4.1.1 adjuvant screening

Pulverizing the dry extract into powder, sieving with 80 mesh sieve, and dividing into 6 parts, each 10 g. Adding different adjuvants according to Table 4.1, mixing, using 75% ethanol as wetting agent, drying, grading, inspecting appearance, dissolubility and fluidity, and evaluating the granule.

Investigation of solubility: according to the specification of the first part of the 2010 edition of the Chinese pharmacopoeia (appendix IC), 2g of the product is taken temporarily because the packaging specification is uncertain, 2g of the particles are precisely weighed, the particles are placed in an 80mL beaker which is dried to constant weight, 80mL of hot water is added, the mixture is stirred for 5 minutes, and whether the mixture is uniformly suspended or not is immediately observed.

Investigation of flowability: the repose angle (repose angle), also called the heap angle, is the angle between the surface of a heap formed by the materials piled on a horizontal plane and the horizontal plane, and is used to measure the fluidity of the powder particles.

TABLE 4.1 adjuvant screening test (unit: g)

From the analysis of the evaluation results of the particles, it can be seen that: the addition of the soluble starch leads the forming rate to be lower and does not accord with the regulations of national formulary, while the dextrin and the lactose all meet the requirements of the national formulary in the aspects of forming rate, dissolubility and fluidity. And dextrin: when the ratio of lactose to lactose is 3:2, the granules have moderate viscosity, easy forming and good dissolubility and fluidity. Dextrin and lactose are used as excipients.

4.1.2 Binder screening

Pulverizing the dry extract into powder, sieving with 80 mesh sieve, and dividing into 4 parts and 10g parts. Simultaneously adding two auxiliary materials of 6g of dextrin and 4g of lactose, uniformly mixing, adding different adhesives, drying, finishing granules, inspecting three factors of granule properties, dissolubility and fluidity, and evaluating the granules.

TABLE 4.2 Binder screening test (unit: g)

As shown in table 4.2, the results show that 95% ethanol works better than 75% ethanol, suggesting that the formulation uses as little water as possible to avoid caking. According to the test results, 10% of vinyl pyrrolidone K30-95% ethanol solution is selected as the adhesive of the formula.

4.2 study of the preparation Process

4.2.1 test for uniformity of drug content at different mixing times

Mixing equipment: a high shear granulator model of van der drying equipment, inc, of Changzhou city, having a capacity of 5L.

Prescription: 500g of dry extract powder; 300g of dextrin; 200g of lactose;

the total amount is 1kg

The test method comprises the following steps: adding prescription amount of dry extract powder and dextrin into a granulating pan, mixing for 1 minute at the speed of main stirring 300rpm and cutting knife 500rpm, then adding prescription amount of lactose, mixing at the speed of main stirring 300rpm and cutting knife 500rpm, stopping stirring at 5, 7.5 and 10 minutes respectively, respectively taking 3g samples at 3 different parts of the surface layer of the material, respectively taking 3g samples at the middle part of the middle layer, respectively taking 3g samples at 3 different parts of the bottom, and measuring the content of phillyrin in the samples by HPLC chromatography, wherein the results are shown in Table 4.3.

TABLE 4.3 test results for drug uniformity at different mixing times

The results of the tests showed that the RSD of the phillyrin content at 5, 7.5 and 10 minutes under the conditions of 300rpm for main stirring and 500rpm for the cutter was 2.92%, 2.37% and 1.87%, indicating that the mixing was performed at 300rpm for main stirring and 500rpm for cutter, and that the phillyrin content uniformity in the granules was better when the stirring was stopped after 10 minutes, so the mixing time was selected to be 10 minutes.

4.2.2 testing of the impact of different cutting times on Soft Material Properties

One part of the uniformly mixed materials is three, under the conditions of main stirring speed of 300rpm and cutting speed of 1500rpm of a cutter, PVPK30-95% ethanol slurry is added, the influence of different cutting time on the shape of a soft material is inspected, the soft material is subjected to wet granulation through a 14-mesh sieve, is dried for 2 hours at 60 ℃, and the moisture and the fluidity of the particles are measured.

TABLE 4.4 test results of the effect of different cutting times on the soft material

The results in Table 4.4 show that the cutting time is 10min, since the hardness of the particles is moderate, the particles are easy to form, the color is consistent, and the particles are uniform after cutting for 10min under the conditions of the main stirring speed of 300rpm and the cutting speed of 1500 rpm.

5 conclusion

The part primarily screens the extraction solvent and the process of the solution through a pharmacodynamic test. Finally, the extraction method of the traditional Chinese medicine particles is determined to be a water extraction and alcohol precipitation method. The water extraction process and the alcohol precipitation process of the solution are optimized through three-factor three-level orthogonal experiments. Meanwhile, the drying and granulating processes are determined through horizontal tests and preliminary stability researches; a comparison test is carried out by adopting a normal pressure drying method and a reduced pressure drying method; and meanwhile, a wet granulation method is adopted for parallel screening, and the technical indexes are respectively fluidity, dissolubility, angle of repose and yield, so that the particle forming method is established.

Finally, the optimal water extraction process of the traditional Chinese medicine granules is determined as follows: extracting for 2 times, wherein each time of decoction is 2 hours, the water addition amount is 8 times, the average content of phillyrin in the dry extract obtained by three parallel verification tests under the process condition is 0.2339%, the average yield of the extract is 24.93%, and the RSD is 1.19%.

The optimal alcohol precipitation process of the traditional Chinese medicine granules comprises the following steps: 70% ethanol, standing for 24 hours, concentrating the extracting solution until the density is 1.1, and carrying out three parallel verification tests under the process condition to obtain an extracting solution, wherein the average content of phillyrin in the obtained dry extract is 16.57%, the average yield of the extract is 0.3889%, and the RSD is 0.94%.

The drying process for finally determining the prescription adopts a vacuum drying method. Dextrin and lactose are selected as auxiliary materials of the prescription (the addition ratio is dextrin: lactose ═ 3:2) and 10% polyvinylpyrrolidone K30-95% ethanol solution is used as the binding agent of the prescription. According to the research on the granulation process of the prescription granules, the prescription amount of dry extract powder and dextrin are primarily determined to be added into a granulation pot, the dry extract powder and the dextrin are mixed for 1 minute at the speed of 300rpm of main stirring and 500rpm of a cutting knife, then the prescription amount of lactose is added, the dry extract powder and the dextrin are mixed at the speed of 300rpm of the main stirring and 500rpm of the cutting knife, the stirring is stopped at 10 minutes respectively, PVPK30-95% ethanol slurry is added under the speed conditions of 300rpm of the main stirring and 1500rpm of the cutting knife, the soft material is subjected to 14-mesh sieve wet granulation, and is dried at 60 ℃.

The traditional Chinese medicine granules are prepared by the optimized process route and process conditions.

EXAMPLE 11 drug substance quality Standard identification

The control substances used for identification and assay in this example were as follows:

andrographolide

[ molecular formula]C₂₀H₃₀O₅

[ molecular weight ]350.44

The crystal (ethanol or methanol) is white prismatic or flaky, odorless and bitter. Dissolving in boiling ethanol, dissolving in methanol or ethanol slightly, dissolving in chloroform very slightly, and dissolving in water or diethyl ether almost, wherein the melting point is 230-231 deg.C.

The source is as follows: china institute for testing and testing food and medicine

Forsythiaside

[ molecular formula]C₂₇H₃₄O₁₁

[ molecular weight ]534.56

[ physicochemical properties ] white crystalline powder. Melting point 184-185 deg.C, dissolving in ethanol, and not dissolving in ether, hexane and chloroform.

Reference herbal medicine of Andrographis paniculata

The identification reference drug lot 121082 and 201505 purchased from China institute for food and drug testing

Herba Taraxaci reference drug

The reference drug lot number 120928-201208 for identification is purchased from China food and drug testing research institute

Fructus forsythiae reference drug

The reference drug lot number 120908 and 201216 for identification are purchased from China institute for food and drug testing

The prescription totally comprises 5 medicines, wherein dandelion, common andrographis herb and weeping forsythia capsule are identified and researched by adopting a thin-layer chromatography, and the method comprises the following steps:

1 authentication

1) Experimental materials and instruments

TABLE 5.1 Experimental materials

TABLE 5.2 Experimental instruments

2) Thin layer identification of Andrographis paniculata Nees

Preparation of test solution

Weighing about 5.0004g of the sample of the herba Typhae clearing dry extract (batch No. 20170714), grinding, adding 30ml of ethanol, carrying out ultrasonic treatment for 30 minutes, filtering, and concentrating the filtrate to 5ml to obtain a sample solution.

Preparation of negative control solution

4.9996g of extract prepared from herba Andrographitis is precisely weighed, and negative control solution is prepared by the same method.

Preparation of reference drug solution

Weighing herba Andrographitis control medicinal material 0.5g, and making into control medicinal material solution with the above method for preparing test solution.

Preparation of control solutions

Accurately weighing 0.0130g of andrographolide standard, adding anhydrous ethanol for dissolving, diluting to 10mL, and shaking to obtain 1.0mg/mL andrographolide solution.

Performing thin layer chromatography, respectively dropping 6 μ L of sample solution, negative control solution and 4 μ L of control solution on the same silica gel G thin layer plate, developing with chloroform-ethyl acetate-methanol (4:3:0.4) as developing agent, taking out, air drying, and inspecting under ultraviolet lamp (254 nm). The results are shown in FIG. 1. In the chromatogram of the test solution, a band with the same color appears at the position corresponding to the chromatogram of the control solution, and the negative part has no interference. The sample strips are better separated, the unfolding effect is better, and the income quality is standard.

3) Thin layer identification of dandelion

Preparation of test solution

Weighing about 2.0020g of herba Typhae extract (batch No. 20170714) of herba Typhae extract, adding 5% formic acid methanol solution 20ml, ultrasonic treating for 20min, filtering, evaporating filtrate to dryness, dissolving residue in 10ml of water, filtering, extracting filtrate with ethyl acetate under shaking for 2 times, 10ml each time, mixing ethyl acetate solutions, evaporating to dryness, and dissolving residue in methanol lmL to obtain sample solution.

Preparation of negative control solution

2.0010g of extract prepared from herba Taraxaci absent is precisely weighed, and negative control solution is prepared by the same method.

Preparation of reference drug solution

Weighing herba Taraxaci as reference material 1.0g, and making into reference material solution by the same method as the above test solution.

Performing thin layer chromatography test, sucking 6 μ l of the above four solutions, respectively dropping on the same silica gel G thin layer plate, developing with butyl acetate-formic acid-water (7: 2.5: 2.5) upper layer solution as developing agent, taking out, air drying, and inspecting under ultraviolet lamp (365 nm).

The results are shown in FIG. 2. In the chromatogram of the test solution, a band with the same color appears at the position corresponding to the chromatogram of the control solution, and the negative part has no interference. The sample strips are better separated, the unfolding effect is better, and the income quality is standard.

4) Thin layer identification of forsythia suspense

Preparation of test solution

About 3.0045g of the sample of the herba Typhae clearing dry extract (batch No. 20170710) is precisely weighed, ground, placed in a 100ml round-bottom flask, added with 20ml of methanol, heated and refluxed for 1h, filtered, and the filtrate is concentrated to 1ml to be used as a test solution.

Preparation of negative control solution

3.0012g of extract prepared from fructus forsythiae lacking materials is precisely weighed, and negative control solution is prepared by the same method.

Preparation of reference drug solution

Weighing fructus forsythiae control medicinal material 1.0g, and making into control medicinal material solution by the same method as the above test solution.

Preparation of control solutions

Accurately weighing 0.0025g of phillyrin standard, adding absolute ethyl alcohol to dissolve, fixing the volume to 10mL, and shaking up to obtain 0.25mg/mL phillyrin solution.

Performing thin layer chromatography test, sucking 5 μ L of the above 4 solutions, respectively dropping on the same silica gel G thin layer plate, developing with chloroform-methanol-water (14:6:1) lower layer solution as developing agent, taking out, air drying, spraying vanillin test solution, and heating at 105 deg.C until the spots are clearly developed.

The results are shown in FIG. 3. In the chromatogram of the test solution, the same color band appears at the position corresponding to the chromatogram of the control solution, and the negative sample has no interference. The sample strips are better separated, the unfolding effect is better, and the income quality is standard.

2 determination of the content

The prescription of the product consists of 5 medicinal materials, the content determination research is carried out on the forsythia with good carbuncle eliminating and stagnation dissipating effects by adopting an HPLC chromatography, and finally, the content determination method is income to the text of the medicine standard.

1) HPLC (high Performance liquid chromatography) determination of content of phillyrin in formula

Chromatographic conditions

The chromatographic column adopts an Agilent C18 column (4.6mm multiplied by 250mm, 5 mu m), acetonitrile-water is taken as a mobile phase (25:75), and isocratic elution is carried out at the flow rate of 1.0 mL/min; the detection wavelength is 277nm, the column temperature is 35 ℃, and the sample injection amount is 10 mu L.

Preparation of the solution

Preparation of control solutions

Precisely weighing 2.0mg of phillyrin reference substance, placing into a 10mL volumetric flask, adding an appropriate amount of methanol, dissolving, fixing volume, and shaking up to obtain the final product.

Preparation of test solution

Precisely weighing 2.0008g of sample, placing in a flask with a plug, adding 20mL of 80% methanol solution, precisely weighing, ultrasonically extracting for 30min, and supplementing weight.

Negative control solution preparation

Preparing negative reference substance lacking fructus forsythiae according to the preparation process of the formula granule, and then operating according to the same method of the preparation method of the test solution to obtain the negative reference substance solution.

Using this chromatographic condition, the forsythin retention time was 12.206 min. And respectively injecting a prescription sample, a fructus forsythiae deficiency negative sample and a reference substance. As a result, the separation degree of phillyrin is good, and the negative is not interfered at the position of the chromatographic peak of phillyrin, and the result is shown in a chromatogram map 4. The phillyrin content was calculated to be 2.004 mg/g.

2) Methodology validation

Linear relationship investigation experiment

Respectively sampling 2, 5, 10, 15, 18 and 20 μ L of phillyrin control solution 0.20mg/mL, measuring according to the above chromatographic conditions, and drawing a standard curve with peak area as ordinate and sampling amount as abscissa, as shown in FIG. 5. The linear regression equation is that y is 117.14x-57.204, and R2 is 0.9999, and the result shows that the phillyrin sample amount has good linear relation with the peak area in the range of 0.4-4.0 mug.

Precision experiment

The forsythin control solution with the concentration of 0.200mg/mL is precisely sucked, the continuous measurement is carried out for 6 times, 10 mu L of forsythin is injected for each time, the measurement is carried out according to the method, the peak area RSD of the forsythin is calculated to be 0.53% (n is 6), and the instrument precision is good.

Repeatability test

6 portions of (batch: 20170601) test sample, 1.0g each, were precisely weighed, prepared by the method of preparing the solution in "(1)", filtered through a 0.22 μm microporous membrane, and then measured, the average forsythin content was 2.004mg g-1, and the RSD was 0.45% (n-6), indicating that the method was excellent in reproducibility.

Stability test

Precisely sucking 10 μ L of the same test sample solution prepared from the sample (batch number: 20170601), and respectively performing sample injection detection for 0, 2, 4, 8, 12 and 24h to obtain the peak area RSD of phillyrin of 0.23%, which indicates that the test sample solution has good stability within 24 h.

Sample application recovery test

6 parts of a sample (the content of phillyrin: 2.004mg g-1) of (batch number: 20170601) are precisely weighed, 0.5g of each part is precisely added with a proper amount of phillyrin reference substance respectively, a test solution is prepared according to the method of the item (1), and the average recovery rate and RSD of the phillyrin are calculated according to the chromatographic condition measurement. The results are shown in Table 6.

Table 6 sample application recovery test results (n ═ 6)

EXAMPLE 12 pharmacodynamic experiment (I)

The experiment carries out main pharmacodynamic research on the heat-clearing, detoxifying and anti-inflammatory effects of the extract of the traditional Chinese medicine composition.

1. Test materials

1.1 test drugs

The extract of the traditional Chinese medicine composition

The content is as follows: contains crude drug 3.125 g/g

Physical and chemical properties: dark brown clear paste

Stability: stabilization

The validity period is as follows: 2 years old

Storage conditions are as follows: and placing the refrigerator refrigerating chamber at 4 ℃.

Use notes: refrigeration after opening

Providing a unit: shanghai market dermatosis hospital

Preparation: preparing the test solution with the required concentration by using distilled water solution.

1.2 Positive control drugs

1) Aspirin enteric-coated tablets, produced by Bayer medicine health care Limited company, with the specification of 100 mg/tablet, batch number BJ 33895.

2) Schiff's acid, Ellanlio pharmaceuticals, Inc., lot No. A82103

3) Hydrocortisone, manufactured by Tianjin Jinyao pharmaceutical Co., Ltd, and having the specification: 5ml 25mg, product batch number 1801161

1.3 reagents and strains:

1) high-activity dry yeast from Meishan produced by Hebei horsepower food Co. Batch number: 89423

2) Staphylococcus aureus standard strain ATCC29213

3) Xylene, Shanghai Rujie chemical Co., Ltd., AR grade, lot number 20170301.

1.4 Main instruments and models

1.4.1 electronic balance QUINTIX3102, Saedolis product

1.4.2 model MC-347 electronic thermometer manufactured by Ohlong (Dalian) Co Ltd

1.4.3 McLeod turbidimeter TA-2XJB, Beijing Tianan Union technologies, Inc

1.5 Experimental animals

1.5.1 SD rats

Male, 220-250 g, SPF grade, provided by Shanghai Seipaibikei laboratory animals Co., Ltd., production license number of laboratory animals: SCXK (Shanghai) 2013-0016;

1.5.2 ICR mice

Male, 19-22 g, SPF grade, provided by shanghai sierpinbika experimental animals ltd, experimental animals production license number: SCXK (Shanghai) 2013-0016;

1.5.3 albino Guinea pig

The male and female dual-purpose, 250 ~ 280g, common grade, Shanghai Jiagan biotechnology limited provides, and the production license number of experimental animals: SCXK (Shanghai) 2015-0005-

1.6 feeding conditions and adaptive feeding time

A breeding place: animal house of medical research and innovation center of Pudong hospital in Shanghai

Feeding conditions and environments: the SPF level 4 th solid-face house is fed, the temperature is 20-24 ℃, the humidity is 40% -60%, the noise is less than or equal to 60 decibels, the ventilation frequency is more than or equal to 15 hours, and the working illumination is 12 hours bright and 12 hours dark. Mice had free diet and water, 1 time of water change for 1-2 days, and 1-2 times of padding change for 1 week.

Adaptive feeding time: animals were acclimatized for 2 days after entry into the room.

1.7 name or code of fodder and drinking water conditions

The name of the feed is as follows: SPF grade mice (Co60 irradiation).

Providing a unit: beijing Ke ao synergetic Fei Ltd.

The main detection items and results of the feed are as follows: the quality inspection report of the nutrition quality detection and the sterility test of the feed proves that the feed is qualified.

Drinking water conditions: providing in water works, and autoclaving.

Padding condition: and (5) wood shaving padding.

2. Test method

2.1 rat fever test:

60 SD rats were tested 3 days before the experiment, and the anal temperature was measured with an electronic thermometer every day to eliminate the stress reaction caused by the measurement of the anal temperature, and the normal body temperature of each rat was recorded. Rats with single body temperature of more than 38.0 ℃ or 3 times of anal temperature fluctuation of more than 0.3 ℃ are eliminated. A total of 54 qualified rats were selected and randomly divided into 6 groups: blank control group, model group, low, medium and high dosage groups of Chinese medicinal composition extract, and aspirin group, each group contains 9 of the above raw materials, and fasting is performed for 12h before experiment, and water can be freely drunk. Rats in each group except the blank control group were heated by injecting 10% yeast suspension 1mL/100g subcutaneously into the back.

The administration method comprises the following steps: perfusing distilled water into the blank control group and the model group; the other animals are administrated with corresponding drugs for intragastric administration, and the low and medium dosages of the experiment are 1.5g/kg, 3g/kg and 4.5g/kg, and the aspirin group is 0.3 g/kg. The parental suspension was injected subcutaneously on the back 0.5 hours after gavage and re-administered 5 hours after molding (in the same manner and dose as the first). And measuring the

body temperature change

1, 2, 3, 4, 6, 8, 10, 12 and 15 hours after the administration, and taking the body temperature change as an effect index.

2.2 Guinea pig yang-syndrome pyocutaneous disease test:

42 common-grade guinea pigs are randomly divided into 6 groups according to body weight, and each group comprises 7 guinea pigs, which are respectively used as blank control group, model group, fusidic acid group, and high, medium and low dosage groups of Chinese medicinal composition extract. The specific method for preparing the yang syndrome pyocutaneous disease animal model comprises the following steps: 24 guinea pigs of cleaning grade were taken and weighed approximately 250-300g and randomly divided into 4 groups of 6 animals each. The experimental infectious bacteria is staphylococcus aureus. One day before experiment, the preserved strain is inoculated with inoculating loop to obtain small amount of lawn, and cultured in culture medium at 37 deg.c for 18 hr to obtain infectious bacteria. One day before the experiment, the long hairs on the chest, abdomen and back of the guinea pig are cut off, then the depilatory is coated on the short hair area, and a proper amount of liquid paraffin is coated on the depilatory area to prevent the skin from drying and cracking. In the experiment of the next day, a piece of skin with a pattern is cut off in an unhairing area by using an aseptic operation program, each guinea pig makes a wound surface with the area of about 1 square centimeter, the bottom of the wound surface can be determined according to the condition of seeing a muscle membrane, and if the wound has blood seepage, the hemostasis is performed by using an aseptic cotton ball under pressure. Injecting 0.5ml of staphylococcus aureus with the concentration of 9 hundred million/ml into each wound surface, making a positive sore and ulcer model after infection, covering the wound surface with gauze and bandaging with medical adhesive plaster. The hair on the back is removed by electric hair clippers and depilatory cream, the area is about 4cm multiplied by 4cm, and each group of animals except the blank control group are injected with staphylococcus aureus suspension with the volume of 300ul in the skin, and the staphylococcus aureus suspension content is about 15 hundred million. The experimental infectious bacteria is staphylococcus aureus, a little lawn of the preserved strain is taken by an inoculating loop one day before the experiment, and the strain is inoculated on an LB culture medium and cultured for 18 hours at 37 ℃ to be used as the infectious bacteria. On day 2, the guinea pig was observed to have a distinct red mass on the back compared to the blank control group, indicating successful model construction.

The administration group guinea pig is administered with the Chinese medicinal composition extract at different doses by intragastric administration (converted from human dose), i.e. low, medium and high dose groups with a intragastric administration volume of 1.5g/kg, 3g/kg and 4.5g/kg, and a intragastric administration volume of 10ml/kg for 2 times within 24 hours, and lasting for 7 days. The blank control group and the model group were administered with an equal volume of physiological saline by weight. Guinea pigs were fed with water from the beginning of dosing using a graduated water bottle with a volume of 200ml per day, and the water intake of the guinea pigs was observed and recorded. The sore surface was observed and photographed with a digital camera. The behavior observation mainly comprises: daily activity, faecal matter, average food intake, conditions of local infections. Observing treatment condition, aversion to cold, fever condition, wound healing condition, mortality and pathological section observation of model pyocutaneous disease tissue.

2.3 mouse auricular swelling test:

60 ICR mice with the weight of 19-22 g are randomly divided into 5 groups, and each group comprises 12 mice, namely a low, medium and high dosage group with 3g/kg, 4.5g/kg and 6g/kg of extracts of the traditional Chinese medicine composition, a hydrocortisone group with the weight of 15mg/kg and a blank control group (the same volume of physiological saline is given according to the weight); the administration is carried out by intragastric administration of each group, the intragastric volume is 20ml/kg, 2 times/day, and 7 days continuously. 30min after the last administration, a micro-sampling gun is used for uniformly smearing 25uL of dimethylbenzene solution on the front side and the back side of the right ear of the mouse respectively, the neck is removed after 30min for killing, the two ears are cut off, a stainless steel punch with the diameter of 8mm is used for punching the left ear and the right ear, and the left ear and the right ear are weighed on an electronic balance. The difference in the weight of the left and right ear pieces was used as an index of the degree of swelling, and the anti-inflammatory action intensity was expressed by the degree of swelling (rag) and the swelling inhibition ratio (%).

3. Statistical methods used for analyzing the data:

the two groups are compared by a t-value method when the variance is uniform and a corrected t-value method when the variance is not uniform.

4. Test results

4.1 rat fever test:

the yeast suspension is injected subcutaneously on the back 0.5 hours after the gavage of the low, medium and high dosage groups and the aspirin group of the traditional Chinese medicine composition extract, and the administration is carried out again 5 hours after the molding (the mode and the dosage are the same as the first time); the animal body temperature rise changes of the low, medium and high dose (1.5g/kg, 3g/kg and 4.5g/kg) groups of the traditional Chinese medicine composition extract are smaller than those of the model group. Wherein the body temperature change value of 1.5g/kg and 3g/kg dose groups after 4 hours, 4.5g/kg after 6 hours and 8 hours after administration is compared with the model group, and the statistical significance is achieved (p is less than 0.05-0.01). The test shows that: the traditional Chinese medicine composition extract can reduce the rise of body temperature caused by yeast. The results are shown in Table 7.

TABLE 7 Effect of the groups on the body temperature of the Dry Yeast pyrogenic rats

(X Shi SD, n is 9)

P <0.05, p <0.01 compared to model groups

4.2 Guinea pig yang-syndrome pyocutaneous disease test:

4.2.1 animal morphology Observation

On the 2 nd day of molding, the skin of each guinea pig group can be observed to see the red, glowing and high-outburst lumps in the hair-removed area of each animal except the blank control group, and the pain is felt by touch, which is in accordance with the clinical yang syndrome with the expression of red, swelling, heat and pain.

4.2.2 Observation of water intake and survival rate of animals

The water intake of animals is increased after the animal model is built, and the animals survive 2 times a day for 7 consecutive days, and the number of the animals survives 2, 3, 7, 1 and 3 in the low, medium and high control group, the model group and the positive medicine group. The survival number of the drug group was significantly higher than that of the model group. The results are shown in Table 8.

TABLE 8 Effect of the groups on the survival of Staphylococcus aureus-induced pyocutaneous disease models

(x Shi SD, n 7)

P <0.05, compared to model controls

4.2.3 comparison of pathological forms of tumor skin

Blank control group: the epidermis and the dermis of the skin have complete structures, the stratum corneum, the stratum lucidum, the stratum granulosum, the acanthocyte layer and the basal layer are clearly demarcated, the structure is complete, no ulcer is formed, and no edema, necrosis and desquamation of the epidermal cells are seen. The structure of the dermal papilla layer and the reticular layer is clear, and the blood vessels do not have congestion and expansion.

Model group: the integrity of the epidermis of the skin is interrupted, ulcers form, there is a lot of bleeding on the surface of the ulcers, more necrotic tissue below, and a lot of neutrophil infiltration at the bottom.

Schiff acid group: the epidermis and the dermis are structurally complete, and sebaceous glands, hair follicles and sweat glands are visible in the dermis layer. A small amount of inflammatory cell infiltration is seen in the deep layer of the dermis, and the inflammatory cell infiltration is scattered in a small amount of bleeding, the fibroblast and histiocyte hyperplasia and granulation tissue formation.

Low dose group of traditional Chinese medicine composition extracts: the integrity of the skin epidermis is interrupted, bleeding occurs on the surface, a necrotic focus is arranged below the skin epidermis, a large amount of neutrophils infiltrate to form a small abscess, histiocytes proliferate and a small amount of granulation tissues are formed.

Traditional Chinese medicine composition extract medium dose groups: the epidermis is complete and slightly thickened, small necrotic foci are formed beside small bleeding foci in the deep layer of the dermis, a large amount of small abscesses formed by the aggregation of neutrophils are seen, and more granulation tissues are formed around the small abscess.

High dose group of Chinese medicinal composition extract: the epidermis is complete and slightly thickened, a small amount of neutrophil infiltration can be seen in the deep layer of the dermis to form micro-abscess, and a large amount of granulation tissue can be seen around the dermis.

The results are shown in FIGS. 6-17.

4.3 mouse auricle swelling test:

the traditional Chinese medicine composition extract is administrated 2 times a day and continuously for 7 days, the mouse auricle swelling caused by xylene can be obviously inhibited, and the reduction of the mouse auricle swelling rate of a dose group and a positive control group in the traditional Chinese medicine composition extract is obviously different from that of a model group (P is less than 0.05), and the results are shown in a table 9.

TABLE 9 Effect of para-xylene on otoxin swelling in mice (x Shi SD, n ═ 12)

P <0.05, compared to placebo

5. Discussion of the related Art

The rat fever model can be successfully replicated by injecting the dry yeast suspension subcutaneously at the back; the traditional Chinese medicine composition extract high, medium and low dose groups have an antipyretic effect on a dry yeast pyrogenic rat model, wherein the traditional Chinese medicine composition extract high dose group has the best effect, and the antipyretic effect is mainly realized by reducing the maximum temperature rise value and advancing the peak platform phase from the analysis of body temperature change.

The acute inflammation animal model of yang syndrome pyocutaneous disease caused by staphylococcus aureus is selected to simulate the symptoms of clinical application, and the histopathology suggests that the extract of the traditional Chinese medicine composition has the effect of promoting the healing of inflammatory pyocutaneous disease. The mouse pinna swelling test caused by xylene also proves that the traditional Chinese medicine composition extract has a certain anti-inflammatory effect.

6. Small knot

The traditional Chinese medicine composition extract is administrated to rats for 1 day and 2 times, the body temperature rise caused by rat yeast can be reduced within the dosage range of 1.5-4.5 g/kg, and the drenching effect is most obvious at the dosage of 4.5 g/kg.

The guinea pig drenches the traditional Chinese medicine composition extract for 1 day and 2 times for 7 consecutive days, and can promote the healing of yang syndrome pyocutaneous disease caused by staphylococcus aureus within the dosage range of 1.5-4.5 g/kg, wherein the drenching effect is better with the dosage of 4.5 g/kg.

The mouse can relieve the auricle swelling caused by xylene by drenching the traditional Chinese medicine composition extract for 1 day and 2 times for 7 days, wherein the effect is particularly obvious when the dosage is 4.5 g/kg.

7. Conclusion

On two models of clearing away heat and toxic materials and a mouse pinna swelling model caused by dimethylbenzene, the traditional Chinese medicine composition disclosed by the invention shows a definite effect of resisting the temperature rise caused by yeast and has a certain anti-inflammatory effect after being administrated. On a rat model for resisting the body temperature rise caused by yeast, the effective dose is 2-4.5 g/kg of extract respectively. Within this dose range, the extract of the Chinese medicinal composition of the present invention shows an effect of increasing the temperature of the antibody. The high-dose sores and ulcers of the traditional Chinese medicine composition extract are obviously better than those of a blank control group in yang syndrome sore and ulcer model tests, and the test results show that the traditional Chinese medicine composition extract has obvious heat-clearing, detoxifying and anti-inflammatory activities.

EXAMPLE 13 pharmacodynamic experiment (II)

The experiment carries out main pharmacodynamic research on the heat-clearing, detoxifying and anti-inflammatory effects of the extracts of the traditional Chinese medicine composition with different mixture ratios.

1. Test materials

1.1 test drugs

The traditional Chinese medicine raw materials of the embodiments 1 to 4 are prepared according to the preparation method of the invention to respectively obtain the first medicine, the second medicine, the third medicine and the fourth medicine.

The content is as follows: each medicine contains 3.125g crude drug/g

Physical and chemical properties: dark brown clear paste

Stability: stabilization

The validity period is as follows: 2 years old

Use notes: refrigeration after opening

Providing a unit: shanghai market dermatosis hospital

1.2 Experimental animals

1.2.1ICR mice

1.2.2 albino guinea pigs,

1.3 feeding conditions and adaptive feeding time

1.4 name or code of feed and drinking water conditions

The name of the feed is as follows: SPF grade mice (Co60 irradiation).

Providing a unit: beijing Ke ao synergetic Fei Ltd.

Drinking water conditions: providing in water works, and autoclaving.

Padding condition: and (5) wood shaving padding.

2. Test method

2.1 Guinea pig yang-syndrome pyocutaneous disease test:

45 common-grade guinea pigs are randomly divided into 5 groups according to body weight, and each group contains 9 guinea pigs, which are respectively used as blank control, one experimental group, two experimental groups, three experimental groups and four experimental groups. The specific method for preparing the yang syndrome pyocutaneous disease animal model comprises the following steps: clean-grade guinea pigs were weighed approximately 250-300 g. The experimental infectious bacteria is staphylococcus aureus. One day before experiment, the preserved strain is inoculated with inoculating loop to obtain small amount of lawn, and cultured in culture medium at 37 deg.c for 18 hr to obtain infectious bacteria. One day before the experiment, the long hairs on the chest, abdomen and back of the guinea pig are cut off, then the depilatory is coated on the short hair area, and a proper amount of liquid paraffin is coated on the depilatory area to prevent the skin from drying and cracking. In the experiment of the next day, a piece of skin with a pattern is cut off in an unhairing area by using an aseptic operation program, each guinea pig makes a wound surface with the area of about 1 square centimeter, the bottom of the wound surface can be determined according to the condition of seeing a muscle membrane, and if the wound has blood seepage, the hemostasis is performed by using an aseptic cotton ball under pressure. Injecting 0.5ml of staphylococcus aureus with the concentration of 9 hundred million/ml into each wound surface, making a positive sore and ulcer model after infection, covering the wound surface with gauze and bandaging with medical adhesive plaster. The hair on the back is removed by electric hair clippers and depilatory cream, the area is about 4cm multiplied by 4cm, and each group of animals except the blank control group are injected with staphylococcus aureus suspension with the volume of 300ul in the skin, and the staphylococcus aureus suspension content is about 15 hundred million. The experimental infectious bacteria is staphylococcus aureus, a little lawn of the preserved strain is taken by an inoculating loop one day before the experiment, and the strain is inoculated on an LB culture medium and cultured for 18 hours at 37 ℃ to be used as the infectious bacteria. On day 2, the guinea pig was observed to have a distinct red mass on the back compared to the blank control group, indicating successful model construction.

The guinea pigs in the experimental group, the experimental group and the experimental group are respectively administrated by intragastric administration (converted according to the human dose) with the same dose of the first, second, third and fourth medicines, wherein the dose is 3g/kg, and the intragastric administration is carried out for 2 times within 24 hours and lasts for 7 days. The blank control group was given an equal volume of saline by body weight. Guinea pigs were fed with water from the beginning of dosing using a graduated water bottle with a volume of 200ml per day, and the water intake of the guinea pigs was observed and recorded. The sore surface was observed and photographed with a digital camera. The behavior observation mainly comprises: daily activity, faecal matter, average food intake, conditions of local infections. Observing treatment condition, aversion to cold, fever condition, wound healing condition, mortality and pathological section observation of model pyocutaneous disease tissue.

2.2 mouse auricular swelling test:

60 ICR mice with the weight of 19-22 g are randomly divided into 5 groups, and each group comprises 12 ICR mice, namely an experimental group, an experimental group and a blank control group (equal volume of physiological saline is given according to the weight); the dose of the gavage administration of each group is 4.5g/kg, 2 times/day and 7 days continuously. 30min after the last administration, a micro-sampling gun is used for uniformly smearing 25uL of dimethylbenzene solution on the front side and the back side of the right ear of the mouse respectively, the neck is removed after 30min for killing, the two ears are cut off, a stainless steel punch with the diameter of 8mm is used for punching the left ear and the right ear, and the left ear and the right ear are weighed on an electronic balance. The difference in the weight of the left and right ear pieces was used as an index of the degree of swelling, and the anti-inflammatory action intensity was expressed by the degree of swelling (rag) and the swelling inhibition ratio (%).

3. Statistical methods used for analyzing the data:

4. Test results

4.1 Guinea pig yang-syndrome pyocutaneous disease test results are shown in Table 10.

TABLE 10 Effect of the groups on the survival of Staphylococcus aureus-induced pyocutaneous disease models

(x Shi SD, n is 9)

4.2, mouse auricle swelling test result:

the traditional Chinese medicine composition extract is administrated 2 times a day and continuously for 7 days, the mouse auricle swelling caused by xylene can be obviously inhibited, and the reduction of the mouse auricle swelling rate of a dose group and a positive control group in the traditional Chinese medicine composition extract is obviously different from that of a model group (P is less than 0.05), and the results are shown in a table 11.

TABLE 11 Effect of para-xylene on pinna swelling in mice

(x Shi SD, n is 12)

5 conclusion

The test results show that the traditional Chinese medicine composition extract prepared according to the proportion has obvious heat-clearing and detoxifying and anti-inflammatory activities.

The foregoing 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 should also be considered as the protection scope of the present invention.

Claims

1. The traditional Chinese medicine composition for treating the suppurative dermatosis is characterized by being prepared from the following raw material medicines in parts by weight: the preparation method of the traditional Chinese medicine composition comprises the following steps:

(2) alcohol precipitation: concentrating the filtrate obtained in step (1) under reduced pressure until the density of the extract is 1.2, slowly adding 95% ethanol until the alcohol concentration is 70%, standing for 24 hours, concentrating the filtrate under reduced pressure until no alcohol smell exists, and continuously concentrating to obtain fluid extract with the relative density of 1.10;

(3) putting the clear paste obtained in the step (2) into a granulating pot, adding dextrin, mixing for 10 minutes at the speed of 300rpm of main stirring and 500rpm of a cutting knife, and stopping stirring to obtain a first semi-finished product; then adding lactose, mixing for 10 minutes at the speed of 300rpm of main stirring and 500rpm of a cutting knife, and stopping stirring to obtain a second semi-finished product; wherein the dextrin and the lactose are prepared from the following components in parts by weight: dextrin: lactose =3:2 addition; and finally, adding 10% of PVPK30-95% ethanol slurry into the second semi-finished product under the conditions of main stirring speed of 300rpm and cutting speed of 1500rpm of a cutting knife, cutting for 10min, sieving with a 14-mesh sieve, carrying out wet granulation, and carrying out vacuum drying at 60 ℃ to obtain the finished product.

2. The Chinese medicinal composition according to claim 1, which is prepared into a clinically acceptable medicinal preparation according to a conventional Chinese medicinal preparation method.

3. Use of the Chinese medicinal composition of claim 1 in the preparation of a medicament for the treatment of purulent skin diseases.

4. The use according to claim 3, wherein the suppurative skin diseases are acne, impetigo, folliculitis, boils, carbuncles, erysipelas.

5. A preparation method of traditional Chinese medicine granules for treating suppurative dermatosis is characterized in that the method is a water extraction and alcohol precipitation method; the method comprises the following steps:

(1) water extraction is carried out twice: weighing the following raw material medicines in parts by weight: the water adding amount of dandelion, common andrographis herb, wild chrysanthemum, weeping forsythia and purslane is 8 times of the total weight of the raw material medicines each time, the raw material medicines are decocted for 2 times and each time lasts for 2 hours, the decoction liquid is merged and filtered to obtain the filtrate;

6. The method of claim 5, wherein the method further comprises thin layer chromatography identification.