CN114159528A - Pharmaceutical composition for preparing insoles for preventing and treating tinea pedis - Google Patents

Abstract

The invention relates to a pharmaceutical composition for preparing insoles for preventing and treating tinea pedis. The medicine composition is prepared by mixing 5-15 parts of raw material traditional Chinese medicine extract, 0.5-1.5 parts of rice bran oil, 50-100 parts of mulberry twig particles and 5-10 parts of adhesive; the traditional Chinese medicine extract comprises, by mass, 10-20 parts of houttuynia cordata, 5-10 parts of Chinese violet, 5-15 parts of yellow flower violet, 5-10 parts of tea leaves and 10-20 parts of walnut leaves; the adhesive is prepared by mixing corn starch or glutinous rice flour, carboxymethyl cellulose and water according to the mass ratio of 30:5: 100. The insole prepared by the medicinal composition has the advantages of simple preparation, low cost, convenient application, greenness, no irritation, no residue, reliable effect and high cure rate, and has extremely high popularization value and application prospect.

Description

Pharmaceutical composition for preparing insoles for preventing and treating tinea pedis

Technical Field

The invention relates to the field of health care products, in particular to a pharmaceutical composition for preparing insoles for preventing and treating tinea pedis.

Background

Tinea pedis, commonly known as dermatophytosis, is a foot dermatosis caused by infectious pathogenic fungi. Tinea pedis is usually of blister type, erosive type, and scaly keratotic type. Whatever the type of tinea pedis, it is characterized by severe itching, causing great physical and mental suffering to the patient. Because the tinea pedis is infectious and chronic infectious disease, the common treatment time is relatively long, the frequent taking of antibiotics such as antifungal and the like brings a lot of side reactions to patients, and the shoes, socks and insoles prepared from Chinese and western medicines are used for preventing and treating the tinea pedis, which brings convenience to the patients.

Disclosure of Invention

In order to overcome the defects of the prior art, the invention focuses on the deep research on the preparation method of the medicament, so that the effective components of the medicament are extracted as comprehensively as possible, and the selected medicinal materials can fully exert the effects of the medicinal materials.

In order to realize the invention, the following technical scheme is adopted:

the medicinal composition for preparing the insoles for preventing and treating tinea pedis is characterized by being prepared by mixing 5-15 parts of raw material traditional Chinese medicine extracts, 0.5-1.5 parts of rice bran oil, 50-100 parts of mulberry twig particles and 5-10 parts of adhesive in parts by weight;

the traditional Chinese medicine in the traditional Chinese medicine extract comprises the following raw materials: herba Houttuyniae, herba Violae, herba crotalariae albidae, folium Camelliae sinensis, and folium Juglandis;

the traditional Chinese medicine extract comprises, by mass, 10-20 parts of houttuynia cordata, 5-10 parts of Chinese violet, 5-15 parts of yellow flower violet, 5-10 parts of tea leaves and 10-20 parts of walnut leaves.

Preferably, the traditional Chinese medicine extract comprises 15 parts of houttuynia cordata, 7.5 parts of Chinese violet, 10 parts of yellow flower violet, 6 parts of tea leaves and 15 parts of walnut leaves by mass.

The adhesive is prepared from corn starch or glutinous rice flour, carboxymethyl cellulose and water according to the mass ratio of corn starch or glutinous rice flour: carboxymethyl cellulose: water =30:5: 100;

the preparation method of the pharmaceutical composition for preparing the insoles for preventing and treating tinea pedis of the invention comprises the following steps:

a preparation method of Chinese medicinal extract

Fresh houttuynia cordata, Chinese violet, tea leaves and walnut leaves are used as raw materials, volatile oil and other volatile components are extracted by a distillation method, then 90% ethanol is used as an extracting agent to extract distilled herb residue slurry, the obtained herb residue slurry extracting solution and distillate are combined and evaporated at low temperature to be concentrated into thick paste, and the thick paste is dried and crushed to obtain the traditional Chinese medicine extract, wherein the process comprises the following steps:

(1) respectively cleaning fresh medicinal materials such as houttuynia cordata, Chinese violet, tea leaves and walnut leaves, mixing the medicinal materials with water according to the mass ratio of 1:0.5-1.5, and homogenizing by a tissue pounder or a homogenizer;

(2) distilling the homogenized material liquid, and collecting distillate, wherein the mass ratio of the distillate generated after the distillation is finished to the homogenized material liquid is 1/3-1/2;

(3) extracting the residue slurry with 90% ethanol at 65 deg.C for 4 hr for 2 times, mixing extractive solutions, filtering, and recovering ethanol from the filtrate to obtain concentrated solution;

(4) uniformly mixing the distillate obtained in the step (2) and the concentrated solution obtained in the step (3), and evaporating at low temperature to concentrate into thick paste;

(5) vacuum drying and crushing the thick paste obtained in the step (4) to obtain the traditional Chinese medicine extract;

the low-temperature evaporation and concentration condition is 50-55 ℃;

B. preparation of mulberry twig granules

(6) Chopping ramulus mori, drying by microwave, crushing and processing into granular powder of 55-65 meshes, diluting bran oil in parts by mass of raw materials with 5 times of absolute ethyl alcohol, uniformly adding the diluted bran oil into the granular powder of the ramulus mori in a spraying manner, and standing for later use in a closed manner for 6 hours;

C. preparation of pharmaceutical compositions

(7) Mixing the raw materials of corn starch or glutinous rice flour, carboxymethyl cellulose and water according to a mass ratio to prepare a uniform adhesive;

(8) and (3) adding the traditional Chinese medicine extract prepared in the step (A) (5) into the adhesive prepared in the step (C) (7), grinding to be uniform, then fully mixing with the mulberry twig particles prepared in the step (B) (6), sieving, placing in a cool and clean dark room, and circulating by breeze to fully dry the materials to obtain the pharmaceutical composition for preventing and treating the tinea pedis and the insoles.

By utilizing the known technology or the published patent technology of the preparation of the known insoles, 15 to 18 g of the medicinal composition is put into a bag body made of cotton cloth, non-woven fabric or bamboo charcoal fiber material with air permeability to prepare a medicinal layer bag, and the medicinal layer bag is uniformly paved and compacted and then is bonded or sewed between wrapping layers with an upper layer and a lower layer to prepare the insoles for preventing and treating the tinea pedis.

The raw medicinal materials have the pharmacological effects that:

yu xing Cao, pungent and slightly cold. It enters lung meridian. Has the functions of clearing away heat and toxic material, eliminating carbuncle, expelling pus, inducing diuresis and treating stranguria. Modern pharmacology indicates that the houttuynia cordata has a strong anti-pathogenic microorganism effect and has a strong antibacterial effect on hemolytic streptococcus, staphylococcus aureus, bacillus influenzae, catacoccus, pneumococcus, escherichia coli, dysentery bacillus, typhoid bacillus and the like; the houttuynia volatile oil has certain inhibiting effect on beta hemolytic streptococcus, staphylococcus aureus, pseudomonas aeruginosa and escherichia coli, wherein the inhibiting effect on the staphylococcus aureus is the greatest. The literature states that: herba Houttuyniae has effect in inhibiting influenza virus and echovirus, and yellow oily substance extracted from herba Houttuyniae has effect in inhibiting various microorganisms (especially yeast and mold).

Viola Yedoensis Makino, bitter, pungent and cold. It enters heart and liver meridians. Has the functions of clearing away heat and toxic material, cooling blood and eliminating swelling. Modern pharmacology indicates that the Chinese violet has strong antibacterial action, anti-inflammatory action and antiviral action, the antibacterial active ingredient contained in the Chinese violet is flavonoid, and the minimum inhibitory concentration of 6 test bacteria of streptococcus dysgalactiae, staphylococcus aureus, escherichia coli, streptococcus agalactiae, streptococcus uberis and salmonella is 0.039, 0.078, 0.156, 0.313, 0.625 and 1.25mg/ml in sequence; the minimum bactericidal concentration for staphylococcus aureus, streptococcus agalactiae and streptococcus uberis is less than or equal to 2.5mg/ml, and the minimum bactericidal concentration for salmonella of streptococcus dysgalactiae and escherichia coli is more than 2.5 mg/ml. The viola yedoensis makino contains flavonoid glycosides and organic acid which have strong bacteriostatic action on staphylococcus aureus, pasteurella suis, escherichia coli, streptococcus and salmonella. The herba Violae decoction and the ethyl acetate part of the herba Violae ethanol extract have strong antibacterial effects on Escherichia coli, salmonella, Staphylococcus aureus and Staphylococcus epidermidis. The result shows that the Chinese violet has strong in-vivo antibacterial effect. In addition, the alcohol extract with the concentration of 31mg/ml and the water extract with the concentration of 62mg/ml also have the inhibiting effect on the leptospira. The Chinese violet has stronger bacteriostatic action on staphylococcus aureus, staphylococcus epidermidis, saprophytic bacteria, enterococcus faecalis, escherichia coli, proteus and the like, and the Chinese violet and the dandelion are found to have stronger in-vitro antibacterial activity when being used together according to the mass ratio of 1:4, have better bacteriostatic action on 4 gram-positive cocci and 4 gram-negative bacilli and show certain bactericidal action on the escherichia coli and the klebsiella. The anti-inflammatory effect of the Chinese violet: in vitro experiments prove that the Chinese violet decoction can regulate the function of immune cells by regulating the secretion of Interleukin (IL) -2 and tumor necrosis factor-a (TNF-a) and reduce the release of macrophage inflammatory mediators under high concentration. The herba Violae decoction is injected into abdominal cavity of mouse at an amount of 0.5-1.5g/kg, and has strong inhibitory effect on mice cotton ball granulation hyperplasia and white rat formaldehyde foot edema due to hyperfiltration of mice skin capillary vessel caused by paraxylene. The antiviral effect is as follows: in vitro experiments prove that the extract of the Chinese violet herb has the activity of resisting Respiratory Syncytial Virus (RSV). The dimethyl sulfoxide extract of the Chinese violet has strong effect of resisting Human Immunodeficiency Virus (HIV) -1 virus in vitro, and the active compound is the sulfonate of polysaccharide with the relative molecular weight of 10000-15000, and the methanol extract of the active compound also shows the activity, but has no strong effect of the dimethyl sulfoxide extract. Through the activity test of the human immunodeficiency virus by adopting the H9 cell line, research results show that the Chinese violet extract can completely inhibit the growth of HIV under the condition of sub-toxic concentration, but does not inhibit the activity of HIV outside cells.

Huanghua Di Ding, bitter, sweet and cold. It enters liver and stomach meridians. Has the functions of clearing away heat and toxic material, eliminating swelling and dissipating stagnation, and inducing diuresis for treating stranguria. Modern pharmacology indicates that the herba crotalariae albidae has broad-spectrum antibacterial action: the herba Violae Hemerocallis decoction has inhibitory effect on Staphylococcus aureus, Diplococcus pneumoniae, meningococcus, Bacillus diphtheriae, Bacillus proteus, Bacillus dysenteriae, and Pseudomonas aeruginosa; the decoction has inhibitory effect on a series of ringworm (such as Trichophyton mentagrophytes and Trichophyton schoenleinii). The herba crotalariae albidae has certain inhibiting effect on Escherichia coli, paratyphoid Bacillus B and Candida albicans. The alcohol extract also has the function of killing tubercle bacillus and leptospira.

Tea leaves are bitter, sweet and slightly cold. It enters heart, lung, stomach and kidney meridians. Has effects in tonifying heart, promoting urination, resisting bacteria, relieving inflammation, astringing, and relieving diarrhea. Modern pharmacology indicates that the tea has the effects of resisting bacteria, detoxifying and diminishing inflammation, and also has the antibacterial effect on salmonella, staphylococcus aureus, type B hemolytic streptococcus, diphtheria bacillus and pseudomonas aeruginosa, and the antibacterial potency is similar to that of coptis chinensis. The tea polyphenol in the tea has strong astringency, and has obvious inhibition and killing effects on pathogenic bacteria and viruses.

The folium Juglandis is the leaf of Juglans regia L of Juglandaceae. Walnut leaves are bitter, astringent and neutral. Has antibacterial, antiinflammatory, parasite killing, repercussive, astringent, and leukorrhagia stopping effects. It is commonly used to treat skin diseases such as tinea, scabies, eczema, etc. Modern pharmacology indicates that the water extract of walnut leaves has good bactericidal effects on diphtheria bacillus and bacillus anthracis, has certain bactericidal effects on streptococcus pneumoniae, staphylococcus aureus, typhoid bacillus, vibrio cholerae, bacillus subtilis and other bacteria, can inhibit the growth and the propagation of bacteria in vivo, and has the antibacterial and anti-inflammatory effects.

The mulberry branch is the tender branch of mulberry, and is slightly bitter and flat. It enters liver meridian. Has the functions of expelling wind-damp and benefiting joints. It is suitable for rheumatalgia, soreness of shoulder, arm and joint, and numbness. The processing method comprises the following steps of collecting tender branches of mulberry branches in spring and autumn, cutting the tender branches into fresh slices and drying the slices in the sun for use: collecting ramulus Mori, removing impurities, slightly soaking, cleaning, moistening, slicing, and drying. The common prescription of mulberry twig comprises: moisture, beriberi: two mulberry branches. Frying to fragrant, one liter of water is added, and the two are decocted. It is taken in the air every day (Sheng Ji Zong Lu).

The rice bran oil has the functions of dispelling wind, relieving itching, diminishing inflammation and eliminating dampness. Can be used for treating various dermatoses. According to the literature reports, the bran coat oil has certain curative effect on various subacute and chronic hypertrophic skin lesions, has small irritation and safe application, and has the effects of relieving itching, forming cutin, slightly stripping, preventing corrosion, resisting bacteria and the like.

The conventional known method for preparing the rice bran oil is to prepare the rice bran oil by using rice bran according to the following method: (1) pricking a plurality of small holes with thick paper by a needle, pasting the bowl or basin mouth, piling bran on the thick paper to form a mountain shape, igniting the thick paper with fire from the top end, and adding bran on the thick paper at any time; (2) when the bran is burnt to a position close to the paper surface, the bran and ash are swept away (without burning the paper surface to prevent the bran from falling into the oil), the paper pasting the bowl mouth is torn off, and the bran oil is poured out. By using modern CO₂The bran oil prepared by the extraction method has better effect than the bran oil prepared by the traditional method.

The invention has the beneficial effects that:

according to the invention, after the homogenization treatment is carried out on fresh raw medicinal materials, the volatile oil, volatile organic substances and fragrant substances in the medicinal materials are firstly distilled out by using distillation equipment, and then the distilled decoction dreg slurry is extracted by using ethanol.

The invention mixes the traditional Chinese medicine extract with the antibacterial and anti-inflammatory effect with the mulberry twig granules with the beriberi preventing and treating effect, not only reduces and avoids other auxiliary materials, but also exerts the treating effect of the traditional Chinese medicine in cooperation with the medicine, and the addition of the rice bran oil can further enhance the itching relieving, antibacterial and anti-inflammatory effects, so that the insole prepared by the medicine composition has reliable effect and high cure rate, seeks a simple and easy administration method for preventing and treating the tinea pedis, and has good practical value and application prospect.

The technical scheme of the invention is clear, and the production process is simple. The manufacturing cost is low, and the application and the replacement of the insole are convenient. Particularly, the invention does not contain chemical synthesis components, has no irritation and residue in the application process, is convenient to apply and low in price, and the satisfaction degree reaches 100 percent through the post-investigation of the test medical record.

Through interviewing a patient trying on the insole, the insole prepared by the pharmaceutical composition has quick curative effect on treating beriberi, particularly obvious effect of relieving pain and itching after uniform reaction, and good effects of absorbing foot sweat and improving foot odor. The insole prepared by the pharmaceutical composition is a pure traditional Chinese medicine product, has the advantages of greenness, no pollution, no side effect and adverse reaction, and has extremely high popularization value and application prospect.

Detailed Description

The invention is further described with reference to the following examples.

Example 1

The preparation of the medicinal composition for preparing the insoles for preventing and treating tinea pedis comprises the following steps:

firstly, taking fresh houttuynia cordata, Chinese violet, tea leaves and walnut leaves as raw materials, extracting volatile oil and volatile organic components by a distillation method, then taking 90% ethanol as an extracting agent, extracting the residue slurry after distillation, combining the obtained extracting solution and distillate, concentrating the extracting solution in vacuum into thick paste, drying and crushing the thick paste to obtain the traditional Chinese medicine extract, wherein the preparation method comprises the following steps:

(1) taking 1500 g of fresh medicinal materials such as houttuynia cordata, 750 g of Chinese violet, 1000 g of Chinese daylily, 600 g of tea and 1500 g of walnut leaves, respectively cleaning, mixing with 5350 g of water, and homogenizing by a tissue pounder or a homogenizer;

(2) distilling the homogenized material liquid, and collecting distillate, wherein the distillate generated after the distillation is 1/3 in the mass ratio of the homogenized material liquid;

(3) extracting the residue slurry after distillation with 90% ethanol as extraction solvent at 65 deg.C under reflux for 2 times (4 hr each time) at a mass ratio of 1:2.5, mixing extractive solutions, filtering, and recovering ethanol from filtrate to obtain concentrated solution;

(4) uniformly mixing the distillate obtained in the step (2) and the concentrated solution obtained in the step (3), and evaporating and concentrating at the low temperature of 50 ℃ to obtain thick paste;

(5) vacuum drying and crushing the thick paste obtained in the step (4) to obtain a traditional Chinese medicine extract for later use;

(6) chopping ramulus mori, drying by microwave, crushing and processing into 60-mesh granular powder, then diluting 10 g of rice bran oil with 5 times of absolute ethyl alcohol, uniformly adding the diluted rice bran oil into 750 g of ramulus mori granular powder in a spraying manner, and sealing and standing for 6 hours for later use;

(7) uniformly mixing 300 g of corn starch, 50 g of carboxymethyl cellulose and 1000 g of water to prepare an adhesive;

(8) weighing 75 g of the traditional Chinese medicine extract prepared in the step (5), adding the traditional Chinese medicine extract into 75 g of adhesive, grinding the mixture evenly, then fully mixing the mixture with the mulberry twig granular powder prepared in the step (6), sieving the mixture, placing the sieved mixture in a cool and clean dark room, and circulating breeze to fully dry the materials to obtain the medicinal composition for preventing and treating the tinea pedis and the insoles.

The preparation method of the insole for preventing and treating tinea pedis comprises the following steps:

a cloth bag is sewn by adopting cotton cloth according to the size of a prefabricated insole, 18 g of the medicinal composition prepared in the embodiment 1 is filled in the cloth bag, the medicinal composition is uniformly dispersed to prepare a medicinal layer cloth bag, then the medicinal layer cloth bag is paved and compacted and is bonded or sewn between wrapping layers with an upper layer and a lower layer by glue, and the insole for preventing and treating tinea pedis is prepared.

Example 2

The preparation of the medicinal composition for preparing the insoles for preventing and treating tinea pedis comprises the following steps:

firstly, taking fresh houttuynia cordata, Chinese violet, tea leaves and walnut leaves as raw materials, extracting volatile oil and volatile organic components by a distillation method, then taking 90% ethanol as an extracting agent, extracting the residue slurry after distillation, combining the obtained extracting solution and distillate, concentrating the extracting solution in vacuum into thick paste, drying and crushing the thick paste to obtain the traditional Chinese medicine extract, wherein the preparation method comprises the following steps:

(1) taking 1000 g of fresh medicinal materials such as houttuynia cordata, 500 g of Chinese violet, 500 g of Chinese daylily, 500 g of tea and 1000 g of walnut leaves, respectively cleaning, mixing with 2425 g of water, and homogenizing by a tissue pounder or a homogenizer;

(2) distilling the homogenized material liquid, and collecting distillate, wherein the distillate generated after the distillation is 1/2 in the mass ratio of the homogenized material liquid;

(3) extracting the residue slurry after distillation with 90% ethanol as extraction solvent at 65 deg.C under reflux for 2 times (4 hr each time) at a mass ratio of 1:2.0, mixing extractive solutions, filtering, and recovering ethanol from filtrate to obtain concentrated solution;

(4) uniformly mixing the distillate obtained in the step (2) and the concentrated solution obtained in the step (3), and evaporating and concentrating at low temperature of 52 ℃ to obtain thick paste;

(5) vacuum drying and crushing the thick paste obtained in the step (4) to obtain a traditional Chinese medicine extract for later use;

(6) chopping ramulus mori, drying by microwave, crushing and processing into 65-mesh granular powder, diluting 5g of rice bran oil with 5 times of absolute ethyl alcohol, uniformly adding the diluted rice bran oil into 500 g of ramulus mori granular powder in a spraying manner, and sealing and standing for 6 hours for later use;

(7) uniformly mixing 300 g of corn starch, 50 g of carboxymethyl cellulose and 1000 g of water to prepare an adhesive;

(8) weighing 50 g of the traditional Chinese medicine extract prepared in the step (5), adding the traditional Chinese medicine extract into 50 g of adhesive, grinding the mixture evenly, then fully mixing the mixture with the mulberry twig granular powder prepared in the step (6), sieving the mixture, placing the sieved mixture in a cool and clean dark room, and circulating breeze to fully dry the materials to obtain the medicinal composition for preventing and treating the tinea pedis and the insoles.

The preparation method of the insole for preventing and treating tinea pedis comprises the following steps:

according to the size of the prefabricated insole, a cloth bag is sewn by adopting cotton cloth, 15 g of the medicinal composition prepared in the embodiment 2 is filled into the cloth bag, the medicinal composition is uniformly dispersed to prepare a medicinal layer cloth bag, then the medicinal layer cloth bag is tiled and compacted and then is bonded or sewn between wrapping layers with an upper layer and a lower layer by using glue, and the insole for preventing and treating tinea pedis is prepared.

Example 3

The preparation of the medicinal composition for preparing the insoles for preventing and treating tinea pedis comprises the following steps:

firstly, taking fresh houttuynia cordata, Chinese violet, tea leaves and walnut leaves as raw materials, extracting volatile oil and volatile organic components by a distillation method, then taking 90% ethanol as an extracting agent, extracting the residue slurry after distillation, combining the obtained extracting solution and distillate, concentrating the extracting solution in vacuum into thick paste, drying and crushing the thick paste to obtain the traditional Chinese medicine extract, wherein the preparation method comprises the following steps:

(1) taking 2000 g of fresh medicinal materials such as houttuynia cordata, 1000 g of Chinese violet, 1500 g of Chinese daylily, 1000 g of tea and 2000 g of walnut leaves, respectively cleaning, mixing with 11250 g of water, and homogenizing by a tissue pounder or a homogenizer;

(2) distilling the homogenized material liquid, and collecting distillate, wherein the distillate generated after the distillation is 1/3 in the mass ratio of the homogenized material liquid;

(3) extracting the residue slurry after distillation with 90% ethanol as extraction solvent at 65 deg.C under reflux for 2 times (4 hr each time) at a material-liquid mass ratio of 1:3.0, mixing extractive solutions, filtering, and recovering ethanol from filtrate to obtain concentrated solution;

(4) uniformly mixing the distillate obtained in the step (2) and the concentrated solution obtained in the step (3), evaporating and concentrating at the low temperature of 55 ℃ to obtain thick paste;

(5) vacuum drying and crushing the thick paste obtained in the step (4) to obtain a traditional Chinese medicine extract for later use;

(6) chopping ramulus mori, drying by microwave, crushing and processing into 55-mesh granular powder, diluting 15 g of rice bran oil with 5 times of absolute ethyl alcohol, uniformly adding the diluted rice bran oil into 1000 g of ramulus mori granular powder in a spraying manner, and sealing and standing for 6 hours for later use;

(7) uniformly mixing 300 g of glutinous rice flour, 50 g of carboxymethyl cellulose and 1000 g of water to prepare an adhesive;

(8) weighing 150 g of the traditional Chinese medicine extract prepared in the step (5), adding the traditional Chinese medicine extract into 100 g of adhesive, grinding the mixture evenly, then fully mixing the mixture with the mulberry twig granular powder prepared in the step (6), sieving the mixture, placing the sieved mixture in a cool and clean dark room, and circulating breeze to fully dry the materials to obtain the medicinal composition for preventing and treating the tinea pedis and the insoles.

The preparation method of the insole for preventing and treating tinea pedis comprises the following steps:

a cloth bag is sewn by adopting cotton cloth according to the size of a prefabricated insole, 16.5 g of the medicinal composition prepared in the embodiment 3 is filled in the cloth bag, the medicinal composition is uniformly dispersed to prepare a medicinal layer cloth bag, then the medicinal layer cloth bag is spread and compacted, and then the medicinal layer cloth bag is bonded or sewed between wrapping layers with an upper layer and a lower layer by using glue to prepare the insole for preventing and treating tinea pedis.

Clinical tests are carried out after the medicinal composition prepared by the invention is prepared into the shoe pad, and the test effects are as follows:

through cooperation with traditional Chinese medical hospitals in Jiangsu Houzhou city, the medical diagnosis shows that 80 cases of tinea pedis are diagnosed in the experiment of applying the insoles prepared by the pharmaceutical composition for preventing and treating the tinea pedis to patients with the tinea pedis, and the patients are all people in the Houzhou city, wherein 62 men and 18 women are aged between 20 and 50 years old. The specific test results are as follows:

the first test group, 22 persons in total, in which 18 men and 4 women were confirmed to have tinea pedis by the diagnosis of a doctor, was put in the shoes of the patients using the insole prepared in example 1 of the present invention, and the results were: 2 cases of patients cured in 2 weeks, 12 cases of patients cured in 1 month, 7 cases of patients cured in 2 months, 1 case of patients cured in 2 semimonths, and the total cure rate is 100%.

The second test group, 30 persons in total, in which 25 men and 5 women were confirmed to have tinea pedis by the diagnosis of a doctor, was put in the shoes of the patients using the insole prepared in example 2 of the present invention, and the results were: 3 patients are cured after wearing the test for 1 month, 18 patients are cured after wearing the test for 2 months, and 7 patients are cured after 3 months, wherein 2 patients are not cured after wearing the test for 3 months, the feeling is improved, and other methods are changed for curing; the total effective rate is 100%, the improvement rate is 6.67%, and the cure rate is 93.33%.

The third test group, 28 persons in total, in which 19 men and 9 women were confirmed to have tinea pedis by the diagnosis of a doctor, was put in the shoes of the patients using the insole prepared in example 3 of the present invention, and the results were: 1 patient cured after wearing the test for 20 days, 6 patients cured after 1 month, and 20 patients cured after 2 months, wherein 1 patient feels better after 1 month without treatment; the total effective rate is 100%, the improvement rate is 3.57%, and the cure rate is 96.43%.

The patients cured in the three test groups are followed by telephone, 1 relapse does not occur in half a year, and no adverse reaction occurs.

And (2) typical safety:

qianzhi, male, 28 years old, suffered from tinea pedis for nearly 1 year, and after the insole prepared in the embodiment 1 of the invention is used for dressing, the male is cured within 2 weeks of the dressing, and no recurrence occurs within half a year of follow-up visit.

Dong' ao, male, 46 years old, suffered from tinea pedis for more than 3 years, and after being treated for many times, the tinea pedis is cured after being worn for 2 months by using the insole prepared in the embodiment 3 of the invention. No recurrence occurs within half a year of the follow-up visit.

The embodiments of the present invention are described in further detail, but the invention is not limited to the embodiments of the present invention, and it is to be understood that modifications and improvements by those skilled in the art may be made without departing from the spirit of the present invention.

Claims (4)

1. The medicinal composition for preparing the insoles for preventing and treating tinea pedis is characterized by being prepared by mixing 5-15 parts of raw material traditional Chinese medicine extracts, 0.5-1.5 parts of rice bran oil, 50-100 parts of mulberry twig particles and 5-10 parts of adhesive in parts by weight; the traditional Chinese medicine in the traditional Chinese medicine extract comprises the following raw materials: herba Houttuyniae, herba Violae, herba crotalariae albidae, folium Camelliae sinensis, and folium Juglandis; wherein the raw medicinal materials comprise, by mass, 10-20 parts of houttuynia cordata, 5-10 parts of Chinese violet, 5-15 parts of Chinese daylily, 5-10 parts of tea leaves and 10-20 parts of walnut leaves; the adhesive is prepared from corn starch or glutinous rice flour, carboxymethyl cellulose and water according to the mass ratio of corn starch or glutinous rice flour: carboxymethyl cellulose: water =30:5: 100.

2. The pharmaceutical composition of claim 1, wherein the traditional Chinese medicines in the traditional Chinese medicine extract comprise the following raw materials: herba Houttuyniae, herba Violae, herba crotalariae albidae, folium Camelliae sinensis, and folium Juglandis; the traditional Chinese medicine composition comprises, by mass, 15 parts of houttuynia cordata, 7.5 parts of Chinese violet, 10 parts of Chinese violet, 6 parts of tea leaves and 15 parts of walnut leaves.

3. A process for the preparation of a pharmaceutical composition according to claims 1-2, comprising the following steps:

a preparation method of Chinese medicinal extract

Fresh houttuynia cordata, Chinese violet, tea leaves and walnut leaves are used as raw materials, volatile oil and other volatile components are extracted by a distillation method, then 90% ethanol is used as an extracting agent to extract distilled herb residue slurry, the obtained herb residue slurry extracting solution and distillate are combined and evaporated at low temperature to be concentrated into thick paste, and the thick paste is dried and crushed to obtain the traditional Chinese medicine extract, wherein the process comprises the following steps:

(1) respectively cleaning fresh medicinal materials such as houttuynia cordata, Chinese violet, tea leaves and walnut leaves, mixing the medicinal materials with water according to the mass ratio of 1:0.5-1.5, and homogenizing by a tissue pounder or a homogenizer;

(2) distilling the homogenized material liquid, and collecting distillate, wherein the mass ratio of the distillate generated after the distillation is finished to the homogenized material liquid is 1/3-1/2;

(3) extracting the residue slurry with 90% ethanol at 65 deg.C for 4 hr for 2 times, mixing extractive solutions, filtering, and recovering ethanol from the filtrate to obtain concentrated solution;

(4) uniformly mixing the distillate obtained in the step (2) and the concentrated solution obtained in the step (3), and evaporating at low temperature to concentrate into thick paste;

(5) vacuum drying and crushing the thick paste obtained in the step (4) to obtain the traditional Chinese medicine extract;

the low-temperature evaporation and concentration condition is 50-55 ℃;

B. preparation of mulberry twig granules

(6) Chopping ramulus mori, drying by microwave, crushing and processing into granular powder of 55-65 meshes, diluting bran oil in parts by mass of raw materials with 5 times of absolute ethyl alcohol, uniformly adding the diluted bran oil into the granular powder of the ramulus mori in a spraying manner, and standing for later use in a closed manner for 6 hours;

C. preparation of pharmaceutical compositions

(7) Mixing the raw materials of corn starch or glutinous rice flour, carboxymethyl cellulose and water according to a mass ratio to prepare a uniform adhesive;

(8) and (3) adding the traditional Chinese medicine extract prepared in the step (A) (5) into the adhesive prepared in the step (C) (7), grinding to be uniform, then fully mixing with the mulberry twig particles prepared in the step (B) (6), sieving, placing in a cool and clean dark room, and circulating by breeze to fully dry the materials to obtain the pharmaceutical composition for preventing and treating the tinea pedis and the insoles.

4. The method of claim 3, wherein said low temperature evaporative concentration in step (4) is at a temperature of 50-55 ℃.