CN107496792B - Gel for treating onychomycosis by diminishing inflammation and resisting bacteria and preparation method thereof - Google Patents

Gel for treating onychomycosis by diminishing inflammation and resisting bacteria and preparation method thereof Download PDF

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CN107496792B
CN107496792B CN201710754237.2A CN201710754237A CN107496792B CN 107496792 B CN107496792 B CN 107496792B CN 201710754237 A CN201710754237 A CN 201710754237A CN 107496792 B CN107496792 B CN 107496792B
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CN107496792A (en
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孙淑萍
李苹苹
居世杰
殷传刘
谢东
余配全
孔孟美
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Wannan Medical College
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Abstract

The invention provides an anti-inflammatory and antibacterial gel for treating onychomycosis and a preparation method thereof, wherein the gel contains the following substances: hydroxypropyl methylcellulose, sodium carboxymethylcellulose, glycerol, azone, miconazole nitrate, aloe oil, seabuckthorn fruit oil, white vinegar, garlic extract, sophora flavescens extract, garden balsam stem extract, pepper extract, stemona extract, folium artemisiae argyi extract, fructus kochiae extract, garden balsam extract, distilled water, 75% ethanol, urea, methyl paraben and ethyl paraben. Compared with the prior art, the gel provided by the invention has the advantages of quick absorption, good compliance, exact curative effect on onychomycosis prevention and treatment, and effects of diminishing inflammation, resisting bacteria, improving the texture and color of nails, treating beriberi and the like, and can obviously improve the onychomycosis of patients and effectively improve the immunity.

Description

Gel for treating onychomycosis by diminishing inflammation and resisting bacteria and preparation method thereof
Technical Field
The invention relates to a gel, in particular to an anti-inflammatory antibacterial gel for treating onychomycosis and a preparation method thereof.
Background
Onychomycosis is an infection of the nail or toenail caused by pathogenic fungi such as dermatophytes, yeast and non-dermatophytes. Scratching causes infection with fungi, such as tinea pedis or tinea cruris, which is the most common cause of onychomycosis in patients, scratching with fingernails, which is hard to endure due to itching, so that the fingernails are stained with many pathogenic fungi, and the fungi invade the skin around the nails or toenails, gradually enter the nail plate through the growth and development of the nails or toenails, and further grow and multiply until the entire nail plate is destroyed to form the onychomycosis. The nails of onychomycosis patients are abnormal in color and form, the nail plates lose luster and are obviously thickened, and the nail plates become brittle and are broken and fall off after a long time, mostly are grey white, and the surfaces of the nails are uneven.
The existing methods for treating onychomycosis include oral medication, nail pulling therapy, external medication and the like. The oral medicines are usually used as antifungal medicines such as scurenol, hydrochloric acid terbinafine, fluconazole and the like, but the treatment course is long and has certain side effect on the body. At present, most of external medicines in the market are prepared from western medicines, and have high irritation. The recurrence rate after treatment is high, and the daily work and life of patients are seriously affected because the patients need to continuously scrape nails during treatment and apply the medicine and then wrap the nails.
Therefore, a novel safe and efficient product for treating the onychomycosis is developed, so that the product has a wide market prospect and can bring gospel to more patients suffering from the onychomycosis.
Disclosure of Invention
The invention aims to provide an anti-inflammatory and antibacterial gel for treating onychomycosis, which contains multiple antibacterial and anti-inflammatory natural components, has no side effect and has a good treatment effect.
The invention also provides a preparation method of the gel for treating onychomycosis by diminishing inflammation and resisting bacteria.
The invention provides an anti-inflammatory and antibacterial gel for treating onychomycosis, which comprises the following raw material components in parts by weight:
Figure BDA0001391793230000021
the garlic extract is prepared by the following method:
weighing appropriate amount of Bulbus Allii, mashing, soaking in water for 0.4-0.8 hr, heating and reflux extracting for 3 times: adding 18-20 times of water for the first time, and extracting for 1.0-2.0 hr; adding 12-18 times of water for the second time, and extracting for 1.0-2.0 hr; adding 8-12 times of water for 3 times, extracting for 0.5-1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 3-5 times g/mL of Bulbus Allii, and filtering.
The sophora flavescens extracting solution is prepared by the following method:
weighing proper amount of radix sophorae flavescentis coarse powder, adding 75% ethanol by volume fraction, soaking for 0.5-1.0h, heating and refluxing for 3 times: adding 16-18 times of 75% ethanol for 1 time, and extracting for 1.5-2.0 hr; adding 75% ethanol in an amount which is 12-14 times that of the extract for the 2 nd time, and extracting for 1.0-1.5 h; adding 12-14 times of 75% ethanol for 3 times, extracting for 0.5-1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating under reduced pressure to 4-6 times of g/mL of radix Sophorae Flavescentis, and filtering.
The garden balsam stem extracting solution is prepared by the following method:
weighing appropriate amount of caulis et folium Gaultheriae Yunnanensis, cutting into pieces, soaking in water for 0.3-0.6 hr, heating and reflux extracting for 3 times: adding 22-25 times of water for the first time, and extracting for 1.0-2.0 hr; adding 20-22 times of water for the second time, and extracting for 1.0-2.0 hr; adding 18-20 times of water for 3 times, extracting for 0.5-1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 3-5 times g/mL of herba Speranskiae Tuberculatae, and filtering to obtain the final product.
The pepper extract is prepared by the following method:
weighing appropriate amount of fructus Zanthoxyli coarse powder, soaking in 75% ethanol for 0.3-0.9 hr, heating and reflux extracting for 3 times: adding 75% ethanol in an amount which is 12-16 times that of the ethanol for the 1 st time, and extracting for 1.0-2.0 h; adding 10-12 times of 75% ethanol for 2 times, and extracting for 1.0-1.5 hr; adding 8-10 times of 75% ethanol for 3 times, extracting for 0.5-1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating under reduced pressure to 2-6 times of g/mL of fructus Zanthoxyli, and filtering to obtain the final product.
The stemona root extracting solution is prepared by the following method:
weighing appropriate amount of radix Stemonae coarse powder, soaking for 0.4-0.6h, heating and reflux extracting for 3 times: adding 15-17 times of water for the first time, and extracting for 1.5-2.0 h; adding 13-15 times of water for the 2 nd time, and extracting for 1.0-1.5 hr; adding 10-13 times of water for 3 times, extracting for 1.0-1.5 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 4-7 times of the mass of radix Stemonae g/mL, and filtering.
The folium artemisiae argyi extracting solution is prepared by the following method:
weighing appropriate amount of folium Artemisiae Argyi, cutting into pieces, soaking in water for 0.5-0.8 hr, heating and reflux extracting for 3 times: adding 18-20 times of water for the first time, and extracting for 1.0-2.0 hr; adding 15-18 times of water for the 2 nd time, and extracting for 1.0-1.5 hr; adding 8-15 times of water for 3 times, extracting for 0.5-1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 3-6 times g/mL of folium Artemisiae Argyi, and filtering.
The belvedere fruit extracting solution is prepared by the following method:
weighing appropriate amount of Kochia scoparia, soaking in water for 0.2-0.8h, heating and reflux extracting for 3 times: adding 16-20 times of water for the first time, and extracting for 1.5-2.5 hr; adding 12-16 times of water for the 2 nd time, and extracting for 1.0-1.5 hr; adding 8-12 times of water for 3 times, extracting for 1.0-1.5 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to volume of 2-4 times g/mL of Kochiae fructus, and filtering.
The impatiens balsamina extract is prepared by the following method:
weighing appropriate amount of flos Impatientis, cutting into pieces, soaking in 75% ethanol for 0.4-0.6 hr, heating and reflux extracting for 3 times: adding 18-20 times of 75% ethanol for 1 time, and extracting for 1.0-2.0 hr; adding 14-18 times of 75% ethanol for 2 times, and extracting for 1.0-1.5 hr; adding 8-12 times of 75% ethanol for 3 times, extracting for 0.5-1.0 hr, filtering each time to obtain filtrate, mixing filtrates, vacuum distilling and concentrating to 6-8 times g/mL of flos Impatientis, and filtering to obtain final product.
The invention provides a preparation method of an anti-inflammatory and antibacterial gel for treating onychomycosis, which comprises the following steps:
a) weighing 0.1-1.0g of hydroxypropyl methylcellulose, adding into 20.0-35.0mL of distilled water, standing overnight to fully swell and dissolve to obtain hydroxypropyl methylcellulose gel solution for later use;
b) weighing 0.1-1.0g of sodium carboxymethylcellulose, adding into 30.0-60.0mL of distilled water, standing overnight to fully swell and dissolve the sodium carboxymethylcellulose, and obtaining sodium carboxymethylcellulose gel liquid for later use;
c) weighing 0.05-0.5g of miconazole nitrate, adding the miconazole nitrate into 0.4-2.3mL of 75% ethanol, standing and fully dissolving the miconazole nitrate to obtain miconazole nitrate solution for later use;
d) weighing 0.05-0.5g of urea, adding into 2.0-5.0mL of distilled water, heating in water bath at 60-70 ℃, stirring while heating, and fully dissolving to obtain a urea solution for later use;
e) respectively measuring 0.2-1.0mL of garlic extract, 0.3-1.5mL of sophora flavescens extract, 0.3-1.6mL of garden balsam stem extract, 0.2-1.2mL of pepper extract, 0.3-1.7mL of radix stemonae extract, 0.3-2.0mL of folium artemisiae argyi extract, 0.2-1.8mL of fructus kochiae extract and 0.3-1.5mL of garden balsam extract, and stirring and mixing uniformly to obtain a mixed solution 1 for later use;
f) respectively weighing 0.1-1.0g of azone, 1.5-3.0g of glycerol, 0.2-1.0g of aloe oil and 0.05-0.5g of sea buckthorn fruit oil, and stirring to uniformly mix to obtain a mixed solution 2 for later use;
g) weighing methyl hydroxybenzoate 0.01-0.08g and ethylparaben 0.01-0.08g, respectively, adding 75% ethanol 0.5-1.0mL, stirring to dissolve to obtain antiseptic solution;
h) mixing hydroxypropyl methylcellulose gel solution, sodium carboxymethylcellulose gel solution, miconazole nitrate solution, urea solution, mixed solution 1, mixed solution 2 and antiseptic solution, stirring, adding 0.2-1.5mL of white vinegar, and stirring to obtain the gel for treating onychomycosis.
The invention comprises the following components:
miconazole nitrate belongs to antifungal drugs, can inhibit the growth of most fungi, and has good antibacterial effect on various deep fungi (such as candida albicans, cryptococcus neoformans, blastomyces and the like), certain epidermal fungi, saccharomycetes and the like. Gram-positive bacteria (e.g., staphylococci, streptococci) and bacilli (e.g., Bacillus anthracis) are also highly sensitive. Can be used for treating skin and nail infection caused by fungi, yeast and other fungi.
The aloe oil contains natural colloid substance water-retention lignin, has strong penetration, strong cleaning and antibacterial effects, also has the effects of diminishing inflammation, reducing swelling, inhibiting bacterial growth, relieving itching, relieving pain and the like, and simultaneously has the effects of inhibiting pathogenic microorganisms and bacteria on the surface of the skin, killing mites harmful to the skin of a human body, preventing the reproduction of body surface microorganisms and preventing skin diseases and onychomycosis.
The seabuckthorn fruit oil contains polyunsaturated fatty acid, sterol, natural vitamins and the like, is a natural antibacterial agent with strong antiviral, antibacterial and bactericidal effects, has very little survival probability of harmful microorganisms causing onychomycosis under the strong bactericidal effect of the seabuckthorn fruit oil, and is frequently used in the preparation formulas of cosmetics and external antibacterial drugs to enhance the antibacterial effect.
The garlic contains garlicin, sulfide and other bactericidal substances, and has obvious inhibiting or strangling effect on various pathogenic bacteria such as staphylococcus, tubercle bacillus, vibrio cholerae and the like. The sulfur compounds contained in the garlic also have strong antibacterial and anti-inflammatory effects, and have an especially obvious inhibiting effect on pathogenic bacteria of onychomycosis.
The sophora flavescens contains alkaloid and other components, can effectively prevent bacterial infection, effectively inhibit the breeding and reproduction of bacteria, create a relatively sterile environment for a use part and a small range around the use part, play a role in surface disinfection, and are named as 'natural killer' for trichophyton rubrum causing onychomycosis. The sophora flavescens ether extract and the alcohol extract have strong bacteriostatic action on staphylococcus aureus; the soaking agent has inhibitory effect on Trichophyton mentagrophytes concentric or Trichophyton schoenleinii. The Yunnan herbal medicine: treat skin itch, tinea and sore due to pathogenic wind, and intractable white dandruff. "
The herba speranskiae tuberculatae contains lignans, and has antiinflammatory and antibacterial effects. The leaves of the garden balsam stem are smashed and directly applied to the surface of the skin, so that the breeding of surrounding bacteria can be effectively inhibited, and the bacterial infection can be effectively relieved. The medicine can achieve the effects of relieving pain and diminishing inflammation by external washing.
Zanthoxylum bungeanum can clear heat, dry dampness, relieve itching and resist bacteria, and is used for treating various tinea and rash with pruritus. The fructus Zanthoxyli has antibacterial, analgesic, anesthetic and anticancer effects. The pepper has obvious bacteriostatic and bactericidal effects on some dermatophytes, and particularly has sensitive effects on some deep fungi. Antifungal experiment of alkaloid in pricklyash peel shows that it has inhibiting effect on yeast-like pathogenic bacteria and subcutaneous and skin pathogenic bacteria.
The stemona root has a certain treatment effect on scabies and eczema of the skin, and has very obvious inhibition effect on various cocci, bacilli and dermatophytes. The stemona decoction is directly applied to the affected part, can improve the metabolism speed in the range, accelerates the regeneration of the tissue of the tuber, and has good promotion effect on the later recovery stage of treating onychomycosis.
The folium Artemisiae Argyi is a broad-spectrum antibacterial drug, and has antibacterial and immunity enhancing effects. Folium Artemisiae Argyi has inhibitory and killing effects on many viruses and bacteria. The folium artemisiae argyi decoction can be externally washed to treat eczema, scabies and tinea, and can eliminate dampness and relieve itching. The folium Artemisiae Argyi burnt product has effect in inhibiting partial fungi of skin. A disinfection test is carried out on the air of a mother room and an infant room by adopting a moxa leaf comburant fumigation method, and the moxa leaf fumigant has the bacteriostatic or bactericidal effect on about 10 common germs such as white larynx bacillus, tubercle bacillus, staphylococcus aureus and the like.
Kochiae fructus is used for treating malignant boil, external skin itching, etc., and has effects of clearing away damp-heat, promoting urination, and resisting dermatophytes. Original materia Medica: ' remove accumulated heat in skin, except skin dampness and itch. The invention utilizes the water-soaking agent to inhibit dermatophytes to different degrees.
The impatiens balsamina L can be used for treating onychomycosis, has strong fungus inhibiting effect, can effectively kill onychomycosis, and has been used for a long time for treating beriberi, onychomycosis and the like. The extract of the folium coptidis from impatiens balsamina L can obviously inhibit the activity of bacteria and fungi, and the water decoction has the functions of anti-inflammation, sterilization and wound surface astringing for external use. Modern pharmacological research finds that impatiens balsamina has an antifungal effect, and different extracts of impatiens balsamina have an inhibitory effect on various main pathogenic fungi causing tinea manuum and tinea pedis.
The white vinegar has certain sterilization and bacteriostasis capability and can dissolve epidermal exfoliative keratinocytes. Can completely inhibit the reproduction of edible vinegar such as Bacillus bacteria, Micrococcus bacteria and pathogenic Escherichia coli. The vinegar also has strong capability of killing various fungi such as tinea. The bibliography: to resolve carbuncle and swelling, disperse water and qi, and kill pathogenic toxin. "
Urea can be used for treating onychomycosis, has strong cutin stripping effect by long-term encapsulation at high concentration, and can inhibit growth and reproduction of tinea fungi.
Azone has strong transdermal effect on hydrophilic and lipophilic drugs, and can increase transdermal absorption effect by times by adding 0.2-2% of azone, so as to enhance drug curative effect and cosmetic use effect, reduce the use of main drugs and nutrients, and reduce cost. The azone is used as a penetrating agent and a penetration enhancer for smearing and massaging external medicines.
Hydroxypropyl methylcellulose is an excellent gel matrix, has thickening capacity and pH stability, and is a widely applied gel matrix.
Sodium carboxymethylcellulose has excellent water solubility, is often used as a thickener and a stabilizer, and is non-toxic and non-irritating.
Glycerol is an excellent dynamic humectant, can release water according to the condition of surrounding tissues, and is beneficial to absorption and utilization of the medicine. Glycerol can form a natural protective film on the affected part, and can protect the wound surface and reduce the loss of the medicine to make the medicine act continuously.
Compared with the prior art, the gel for treating onychomycosis provided by the invention has the advantages that the effective components are extracted from natural medicines such as garlic, sophora flavescens, garden balsam stem, pepper, radix stemonae, folium artemisiae argyi and fructus kochiae, the effect of treating onychomycosis is remarkable, the original appearance and function of the fingernails or toes of a patient can be restored, and the gel is small in side effect, not easy to relapse and the like compared with similar medicines in the market.
Compared with the prior art, the invention combines the drug extract with the water-soluble gel matrix with better absorptivity, has excellent bactericidal effect, can recover the original shape and function of the nail or toe of a patient while treating the onychomycosis, and greatly improves the life quality of the patient. In addition, the traditional Chinese medicine composition has the functions of diminishing inflammation and resisting oxidation while treating the onychomycosis, and can create good and healthy hand and foot environments.
Detailed Description
The present invention will be further described with reference to the following examples.
Example 1
The gel for treating the onychomycosis by diminishing inflammation and resisting bacteria comprises the following raw material components in proportion:
Figure BDA0001391793230000081
Figure BDA0001391793230000091
1.1 preparation of Garlic extract
Weighing 50g of garlic, mashing, soaking for 0.4h, heating and refluxing for 3 times: adding 18 times of water for the first time, and extracting for 1.0 h; adding 12 times of water for the 2 nd time, and extracting for 1.0 h; adding 8 times of water for 3 times, extracting for 0.5 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 3 times g/mL of Bulbus Allii, and filtering.
1.2 preparation of Sophora flavescens extract
Weighing 45g of sophora flavescens coarse powder, soaking for 0.5h, heating and refluxing for 3 times: adding 16 times of 75% ethanol at the 1 st time, and extracting for 1.5 hr; adding 12 times of 75% ethanol for 2 times, and extracting for 1.0 hr; adding 12 times of 75% ethanol for 3 times, extracting for 0.5 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating under reduced pressure to 4 times g/mL of radix Sophorae Flavescentis, and filtering to obtain the final product.
1.3 preparation of extract of speranskia tuberculata
Weighing 80g of garden balsam stem, cutting into pieces, soaking for 0.3h, heating and refluxing for extraction for 3 times: adding 22 times of water for the first time, and extracting for 1.0 h; adding 20 times of water for the 2 nd time, and extracting for 1.0 h; adding 18 times of water for 3 times, extracting for 0.5 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 3 times g/mL of herba Speranskiae Tuberculatae, and filtering to obtain the final product.
1.4 preparation of Zanthoxylum bungeanum extract
Weighing 40g of pepper coarse powder, soaking in 75% ethanol for 0.3h, heating and refluxing for 3 times: adding 12 times of 75% ethanol for 1 time, and extracting for 1.0 hr; adding 10 times of 75% ethanol for 2 times, and extracting for 1.0 hr; adding 8 times of 75% ethanol for 3 times, extracting for 0.5 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating under reduced pressure to 2 times g/mL of fructus Zanthoxyli, and filtering to obtain the final product.
1.5 preparation of Stemona root extract
Weighing 50g of radix stemonae coarse powder, soaking for 0.4h, heating and refluxing for extraction for 3 times: adding 15 times of water for the first time, and extracting for 1.5 h; adding 13 times of water for 2 times, and extracting for 1.0 h; adding 10 times of water for 3 times, extracting for 1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 4 times g/mL of radix Stemonae, and filtering.
1.6 preparation of the extract of Artemisia princeps Pampanini
Weighing 70g of folium artemisiae argyi, shearing, soaking for 0.5h, heating and refluxing for extraction for 3 times: adding 18 times of water for the first time, and extracting for 1.0 h; adding 15 times of water for the 2 nd time, and extracting for 1.0 h; adding 8 times of water for 3 times, extracting for 0.5 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 3 times g/mL of folium Artemisiae Argyi, and filtering.
1.7 preparation of Kochiae fructus extract
Weighing 45g of broom cypress fruit, soaking for 0.3h, heating and refluxing for 3 times: adding 16 times of water for the first time, and extracting for 1.5 h; adding 12 times of water for the 2 nd time, and extracting for 1.0 h; adding 8 times of water for 3 times, extracting for 1.0h, filtering each time to obtain filtrate, mixing filtrates, concentrating the volume of the filtrate to 2 times g/mL of the mass of Kochiae fructus, and filtering to obtain the final product.
1.8 preparation of balsam extract
Weighing 55g of impatiens balsamina, cutting into pieces, soaking for 0.4h, heating and refluxing for extraction for 3 times: adding 18 times of 75% ethanol at the 1 st time, and extracting for 1.0 h; adding 14 times of 75% ethanol for 2 times, and extracting for 1.0 hr; adding 8 times of 75% ethanol into the filtrate 3 times, extracting for 0.5 hr, filtering each time to obtain filtrate, mixing filtrates, vacuum distilling and concentrating to 6 times g/mL of flos Impatientis, and filtering to obtain the final product.
1.9 preparation of gel for anti-inflammatory, antibacterial and treatment of onychomycosis
a) Weighing 0.2g of hydroxypropyl methylcellulose, adding into 20.0mL of distilled water, standing overnight to fully swell and dissolve the hydroxypropyl methylcellulose to obtain hydroxypropyl methylcellulose gel liquid for later use;
b) weighing 0.1g of sodium carboxymethylcellulose, adding into 30.0mL of distilled water, standing overnight to fully swell and dissolve the sodium carboxymethylcellulose, and obtaining sodium carboxymethylcellulose gel liquid for later use;
c) weighing 0.05g of miconazole nitrate, adding the miconazole nitrate into 0.4mL of 75% ethanol, standing and fully dissolving the miconazole nitrate to obtain a miconazole nitrate solution for later use;
d) weighing 0.05g of urea, adding the urea into 2.0mL of distilled water, heating in a water bath at 60 ℃, stirring while heating, and fully dissolving the urea to obtain a urea solution for later use;
e) respectively measuring 0.2mL of garlic extract, 0.3mL of sophora flavescens extract, 0.3mL of garden balsam stem extract, 0.2mL of pepper extract, 0.3mL of radix stemonae extract, 0.3mL of folium artemisiae argyi extract, 0.2mL of fructus kochiae extract and 0.3mL of garden balsam extract, and uniformly stirring and mixing to obtain a mixed solution 1 for later use;
f) respectively weighing 0.1g of azone, 1.5g of glycerol, 0.2g of aloe oil and 0.05g of sea buckthorn fruit oil, and stirring by using a stirrer to uniformly mix the materials to obtain a mixed solution 2 for later use;
g) weighing 0.01g of methyl paraben and 0.01g of ethyl paraben respectively, adding 0.5mL of 75% ethanol, and stirring to dissolve to obtain a preservative solution for later use;
h) mixing the prepared hydroxypropyl methylcellulose gel solution, sodium carboxymethylcellulose gel solution, miconazole nitrate solution, urea solution, mixed solution 1, mixed solution 2 and preservative solution, stirring, adding 0.2mL of white vinegar, and stirring with a stirrer to obtain the gel for treating onychomycosis.
Example 2
The gel for treating the onychomycosis by diminishing inflammation and resisting bacteria comprises the following raw material components in proportion:
Figure BDA0001391793230000121
Figure BDA0001391793230000131
2.1 preparation of Garlic extract
Weighing garlic 40g, mashing, soaking for 0.6h, heating and reflux extracting for 3 times: adding 18 times of water for the first time, and extracting for 1.5 h; adding 16 times of water for 2 times, and extracting for 1.5 h; adding 10 times of water for 3 times, extracting for 1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 4 times g/mL of Bulbus Allii, and filtering.
2.2 preparation of Sophora flavescens extractive solution
Weighing 35g of sophora flavescens coarse powder, soaking for 0.8h, heating and refluxing for 3 times: adding 16 times of 75% ethanol at the 1 st time, and extracting for 1.5 hr; adding 12 times of 75% ethanol for 2 times, and extracting for 1.5 hr; adding 12 times of 75% ethanol for 3 times, extracting for 1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating under reduced pressure to 5 times g/mL of radix Sophorae Flavescentis, and filtering to obtain the final product.
2.3 preparation of extract of speranskia tuberculata
Weighing 30g of garden balsam stem, cutting into pieces, soaking for 0.5h, heating and refluxing for extraction for 3 times: adding 24 times of water for the first time, and extracting for 1.5 h; adding 20 times of water for 2 times, and extracting for 1.5 h; adding 18 times of water for 3 times, extracting for 1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 4 times g/mL of herba Speranskiae Tuberculatae, and filtering to obtain the final product.
2.4 preparation of Zanthoxylum bungeanum extract
Weighing 25g of pepper coarse powder, soaking for 0.5h, heating and refluxing for 3 times: adding 14 times of 75% ethanol at the 1 st time, and extracting for 1.5 hr; adding 12 times of 75% ethanol for 2 times, and extracting for 1.5 hr; adding 10 times of 75% ethanol for 3 times, extracting for 1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating under reduced pressure to 4 times g/mL of fructus Zanthoxyli, and filtering to obtain the final product.
2.5 preparation of Stemona root extract
Weighing 40g of radix stemonae coarse powder, soaking for 0.5h, heating and refluxing for extraction for 3 times: adding 16 times of water for the first time, and extracting for 1.5 h; adding 14 times of water for the 2 nd time, and extracting for 1.0 h; adding 12 times of water for 3 times, extracting for 1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 5 times g/mL of radix Stemonae, and filtering.
2.6 preparation of Artemisia princeps Pampanini extract
Weighing 65g of folium artemisiae argyi, shearing, soaking for 0.6h, heating and refluxing for extraction for 3 times: adding 20 times of water for the first time, and extracting for 1.5 h; adding 16 times of water for 2 times, and extracting for 1.5 h; adding 12 times of water for 3 times, extracting for 1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 4 times g/mL of folium Artemisiae Argyi, and filtering.
2.7 preparation of Kochiae fructus extract
Weighing 60g of broom cypress fruit, soaking for 0.5h, heating and refluxing for 3 times: adding 18 times of water for the first time, and extracting for 2.0 h; adding 14 times of water for 2 times, and extracting for 1.5 h; adding 10 times of water for 3 times, extracting for 1.0h, filtering each time to obtain filtrate, mixing filtrates, concentrating the volume of the filtrate to 3 times g/mL of Kochiae fructus, and filtering to obtain the final product.
2.8 preparation of balsam extract
Weighing 55g of impatiens balsamina, cutting into pieces, soaking for 0.5h, heating and refluxing for extraction for 3 times: adding 20 times of 75% ethanol for 1 time, and extracting for 1.5 hr; adding 16 times of 75% ethanol for 2 times, and extracting for 1.0 hr; adding 10 times of 75% ethanol for 3 times, extracting for 1.0 hr, filtering each time to obtain filtrate, mixing filtrates, vacuum distilling and concentrating to 7 times g/mL of flos Impatientis, and filtering to obtain the final product.
2.9 preparation of gel for anti-inflammatory, antibacterial and treating onychomycosis
a) Weighing 0.6g of hydroxypropyl methylcellulose, adding into 30.0mL of distilled water, standing overnight to fully swell and dissolve the hydroxypropyl methylcellulose to obtain hydroxypropyl methylcellulose gel liquid for later use;
b) weighing 0.5g of sodium carboxymethylcellulose, adding into 50.0mL of distilled water, standing overnight to fully swell and dissolve the sodium carboxymethylcellulose, and obtaining sodium carboxymethylcellulose gel liquid for later use;
c) weighing 0.3g of miconazole nitrate, adding the miconazole nitrate into 2.0mL of 75% ethanol, standing and fully dissolving the miconazole nitrate to obtain a miconazole nitrate solution for later use;
d) weighing 0.2g of urea, adding the urea into 3.0mL of distilled water, heating in a water bath at 65 ℃, stirring while heating, and fully dissolving the urea to obtain a urea solution for later use;
e) respectively measuring 0.8mL of garlic extract, 0.6mL of sophora flavescens extract, 0.9mL of garden balsam stem extract, 0.8mL of pepper extract, 1.2mL of radix stemonae extract, 1.5mL of folium artemisiae argyi extract, 0.8mL of fructus kochiae extract and 1.0mL of garden balsam extract, and uniformly stirring and mixing to obtain a mixed solution 1 for later use;
f) respectively weighing 0.5g of azone, 2.0g of glycerol, 0.5g of aloe oil and 0.3g of sea buckthorn fruit oil, and stirring by using a stirrer to uniformly mix to obtain a mixed solution 2 for later use;
g) weighing 0.04g of methyl paraben and 0.02g of ethyl paraben respectively, adding 0.6mL of 75% ethanol, and stirring to dissolve the methyl paraben and the ethyl paraben to obtain a preservative solution for later use;
h) mixing the hydroxypropyl methylcellulose gel solution, the sodium carboxymethylcellulose gel solution, the miconazole nitrate solution, the urea solution, the mixed solution 1, the mixed solution 2 and the preservative solution, uniformly stirring, adding 1.0mL of white vinegar, and uniformly stirring by using a stirrer to obtain the gel for diminishing inflammation, resisting bacteria and treating onychomycosis.
Example 3
The gel for treating the onychomycosis by diminishing inflammation and resisting bacteria comprises the following raw material components in proportion:
Figure BDA0001391793230000151
Figure BDA0001391793230000161
3.1 preparation of Garlic extract
Weighing garlic 40g, mashing, soaking for 0.8h, heating and reflux extracting for 3 times: adding 20 times of water for the first time, and extracting for 2.0 h; adding 18 times of water for 2 times, and extracting for 2.0 h; adding 12 times of water in the 3 rd time, extracting for 1.0h, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 5 times g/mL of Bulbus Allii, and filtering.
3.2 preparation of Sophora flavescens extractive solution
Weighing 30g of sophora flavescens coarse powder, soaking for 1.0h, heating and refluxing for extraction for 3 times: adding 18 times of 75% ethanol for 1 time, and extracting for 2.0 hr; adding 14 times of 75% ethanol for 2 times, and extracting for 1.5 hr; adding 12 times of 75% ethanol for 3 times, extracting for 1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating under reduced pressure to 6 times g/mL of radix Sophorae Flavescentis, and filtering to obtain the final product.
3.3 preparation of extract of speranskia tuberculata
Weighing 75g of garden balsam stem, cutting into pieces, soaking for 0.6h, heating and refluxing for extraction for 3 times: adding 25 times of water for the first time, and extracting for 2.0 h; adding 22 times of water for the 2 nd time, and extracting for 2.0 h; adding 20 times of water for 3 times, extracting for 1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 5 times g/mL of herba Speranskiae Tuberculatae, and filtering to obtain the final product.
3.4 preparation of Zanthoxylum bungeanum extract
Weighing 20g of pepper coarse powder, soaking for 0.9h, heating and refluxing for 3 times: adding 16 times of 75% ethanol at 1 time, and extracting for 2.0 hr; adding 12 times of 75% ethanol for 2 times, and extracting for 1.5 hr; adding 10 times of 75% ethanol for 3 times, extracting for 1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating under reduced pressure to 6 times g/mL of fructus Zanthoxyli, and filtering to obtain the final product.
3.5 preparation of Stemona root extract
Weighing 50g of radix stemonae coarse powder, soaking for 0.6h, heating and refluxing for extraction for 3 times: adding 17 times of water for the first time, and extracting for 2.0 h; adding 15 times of water for 2 times, and extracting for 1.5 h; adding 13 times of water for 3 times, extracting for 1.5h, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 7 times g/mL of radix Stemonae, and filtering.
3.6 preparation of Artemisia princeps Pampanini extract
Weighing 85g of folium artemisiae argyi, shearing, soaking for 0.8h, heating, refluxing and extracting for 3 times: adding 20 times of water for the first time, and extracting for 2.0 h; adding 18 times of water for 2 times, and extracting for 1.5 h; adding 15 times of water for 3 times, extracting for 1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 6 times g/mL of folium Artemisiae Argyi, and filtering.
3.7 preparation of Kochiae fructus extract
Weighing 50g of broom cypress fruit, soaking for 0.8h, heating and refluxing for 3 times: adding 20 times of water for the first time, and extracting for 2.5 h; adding 16 times of water for 2 times, and extracting for 1.5 h; adding 12 times of water in the 3 rd time, extracting for 1.5h, filtering each time to obtain filtrate, mixing filtrates, concentrating the volume of the filtrate to 4 times g/mL of the mass of Kochiae fructus, and filtering to obtain the final product.
3.8 preparation of balsam extract
Weighing 80g of impatiens balsamina, cutting into pieces, soaking for 0.6h, heating and reflux-extracting for 3 times: adding 20 times of 75% ethanol for 1 time, and extracting for 2.0 hr; adding 18 times of 75% ethanol for 2 times, and extracting for 1.5 hr; adding 12 times of 75% ethanol for 3 times, extracting for 1.0 hr, filtering each time to obtain filtrate, mixing filtrates, vacuum distilling and concentrating to 8 times g/mL of flos Impatientis, and filtering to obtain the final product.
3.9 preparation of gel for anti-inflammatory, antibacterial and treatment of onychomycosis
a) Weighing 1.0g of hydroxypropyl methylcellulose, adding into 35.0mL of distilled water, standing overnight to fully swell and dissolve the hydroxypropyl methylcellulose to obtain hydroxypropyl methylcellulose gel liquid for later use;
b) weighing 1.0g of sodium carboxymethylcellulose, adding into 60.0mL of distilled water, standing overnight to fully swell and dissolve the sodium carboxymethylcellulose, and obtaining sodium carboxymethylcellulose gel liquid for later use;
c) weighing 0.5g of miconazole nitrate, adding the miconazole nitrate into 2.3mL of 75% ethanol, standing and fully dissolving the miconazole nitrate to obtain a miconazole nitrate solution for later use;
d) weighing 0.5g of urea, adding the urea into 5.0mL of distilled water, heating in a water bath at 70 ℃, stirring while heating, and fully dissolving the urea to obtain a urea solution for later use;
e) respectively measuring 1.0mL of garlic extract, 1.5mL of sophora flavescens extract, 1.6mL of garden balsam stem extract, 1.2mL of pepper extract, 1.7mL of radix stemonae extract, 2.0mL of folium artemisiae argyi extract, 1.8mL of fructus kochiae extract and 1.5mL of garden balsam extract, and uniformly stirring and mixing to obtain a mixed solution 1 for later use;
f) respectively weighing 1.0g of azone, 3.0g of glycerol, 1.0g of aloe oil and 0.5g of sea buckthorn fruit oil, and stirring by using a stirrer to uniformly mix the materials to obtain a mixed solution 2 for later use;
g) weighing 0.08g of methyl paraben and 0.08g of ethyl paraben respectively, adding 1.0mL of 75% ethanol, and stirring to dissolve the methyl paraben and the ethyl paraben to obtain a preservative solution for later use;
h) mixing the hydroxypropyl methylcellulose gel solution, the sodium carboxymethylcellulose gel solution, the miconazole nitrate solution, the urea solution, the mixed solution 1, the mixed solution 2 and the preservative solution, uniformly stirring, adding 1.5mL of white vinegar, and uniformly stirring by using a stirrer to obtain the gel for diminishing inflammation, resisting bacteria and treating onychomycosis.
Example 4
4.1 Properties
The product is a gel with proper viscosity, fineness and uniformity, good spreadability and good skin absorbability.
4.2 pH check
Dipping a small amount of gel agent by a moistened pH test paper, wherein the pH value is 6-7.
4.3 Cold-Heat test
The gel is packaged in a transparent cosmetic bottle and refrigerated in a refrigerator at 4 ℃ for about one week to observe no layering phenomenon. The phenomenon of layering and odor change and the like is avoided in a constant temperature box with the temperature of 55 ℃ for 24 hours.
4.4 centrifugal test
The gel is packaged in a centrifuge tube and centrifuged for 20min at 3000r/min, and no layering phenomenon occurs.
4.5 irritation test and allergy test
The white mice were shaved on their backs, and the gels prepared in examples 1, 2, and 3 were applied to the shaved parts, respectively, and compared with the non-applied parts, resulting in no irritation or allergic reaction.
4.6 Room temperature standing test
The gels prepared in the examples 1, 2 and 3 are placed in a cosmetic bottle and are stood at room temperature for 6 months, and no layering phenomenon, no change in feeling after use and no change in odor are caused.
Example 5
The gel agent is used for investigating comprehensive effect
The efficacy of the gels prepared in examples 1, 2 and 3 was evaluated by the use of a feeling of trial. The gel prepared in the examples 1, 2 and 3 is used for treating onychomycosis 2 times a day for 3 weeks. The using effects of the ingredients are divided into 5 points: the score of 5 is the highest score, which represents good and very satisfactory; 4, the division is better; 3 is acceptable; when the amount is less than 3 points, the results are not acceptable. The average score of each item is as follows. The results are shown in Table 1:
table 1 comprehensive effect investigation
Figure BDA0001391793230000201
In conclusion, the gel prepared by the invention has the advantages of quick absorption, good compliance, definite curative effect on onychomycosis, and effects of diminishing inflammation, resisting bacteria, improving the texture and color of nails, treating beriberi and the like, and can obviously improve the onychomycosis of patients and effectively improve the immunity.

Claims (2)

1. The gel for treating the onychomycosis by diminishing inflammation and resisting bacteria is characterized by comprising the following raw material components in parts by weight:
hydroxypropyl methylcellulose 0.1-1.0g
Sodium carboxymethylcellulose 0.1-1.0g
1.5-3.0g of glycerin
Azone 0.1-1.0g
Miconazole nitrate 0.05-0.5g
Aloe oil 0.2-1.0g
Sea buckthorn fruit oil 0.05-0.5g
0.2-1.5mL of white vinegar
Bulbus Allii extractive solution 0.2-1.0mL
0.3-1.5mL of sophora flavescens extracting solution
Herba speranskiae tuberculatae extract 0.3-1.6mL
0.2-1.2mL of pepper extract
0.3-1.7mL of stemona root extract
Folium Artemisiae Argyi extract 0.3-2.0mL
0.2-1.8mL of broom cypress fruit extract
0.3-1.5mL of impatiens balsamina extract
Distilled water 52.0-100.0mL
75% ethanol 0.9-3.3mL
0.05-0.5g of urea
Nipagin methyl ester 0.01-0.08g
0.01-0.08g of ethylparaben;
the garlic extract is prepared by the following method:
weighing appropriate amount of Bulbus Allii, mashing, soaking in water for 0.4-0.8 hr, heating and reflux extracting for 3 times: adding 18-20 times of water for the first time, and extracting for 1.0-2.0 hr; adding 12-18 times of water for the second time, and extracting for 1.0-2.0 hr; adding 8-12 times of water for 3 times, extracting for 0.5-1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 3-5 times g/mL of Bulbus Allii, and filtering;
the sophora flavescens extracting solution is prepared by the following method:
weighing proper amount of radix sophorae flavescentis coarse powder, adding 75% ethanol by volume fraction, soaking for 0.5-1.0h, heating and refluxing for 3 times: adding 16-18 times of 75% ethanol for 1 time, and extracting for 1.5-2.0 hr; adding 75% ethanol in an amount which is 12-14 times that of the extract for the 2 nd time, and extracting for 1.0-1.5 h; adding 12-14 times of 75% ethanol for 3 times, extracting for 0.5-1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating under reduced pressure to 4-6 times of g/mL of radix Sophorae Flavescentis, and filtering;
the garden balsam stem extracting solution is prepared by the following method:
weighing appropriate amount of caulis et folium Gaultheriae Yunnanensis, cutting into pieces, soaking in water for 0.3-0.6 hr, heating and reflux extracting for 3 times: adding 22-25 times of water for the first time, and extracting for 1.0-2.0 hr; adding 20-22 times of water for the second time, and extracting for 1.0-2.0 hr; adding 18-20 times of water for 3 times, extracting for 0.5-1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 3-5 times g/mL of herba Speranskiae Tuberculatae, and filtering to obtain the final product;
the pepper extract is prepared by the following method:
weighing appropriate amount of fructus Zanthoxyli coarse powder, soaking in 75% ethanol for 0.3-0.9 hr, heating and reflux extracting for 3 times: adding 75% ethanol in an amount which is 12-16 times that of the ethanol for the 1 st time, and extracting for 1.0-2.0 h; adding 10-12 times of 75% ethanol for 2 times, and extracting for 1.0-1.5 hr; adding 8-10 times of 75% ethanol for 3 times, extracting for 0.5-1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating under reduced pressure to 2-6 times g/mL of fructus Zanthoxyli, and filtering to obtain final product;
the stemona root extracting solution is prepared by the following method:
weighing appropriate amount of radix Stemonae coarse powder, soaking for 0.4-0.6h, heating and reflux extracting for 3 times: adding 15-17 times of water for the first time, and extracting for 1.5-2.0 h; adding 13-15 times of water for the 2 nd time, and extracting for 1.0-1.5 hr; adding 10-13 times of water for 3 times, extracting for 1.0-1.5 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 4-7 times g/mL of radix Stemonae, and filtering;
the folium artemisiae argyi extracting solution is prepared by the following method:
weighing appropriate amount of folium Artemisiae Argyi, cutting into pieces, soaking in water for 0.5-0.8 hr, heating and reflux extracting for 3 times: adding 18-20 times of water for the first time, and extracting for 1.0-2.0 hr; adding 15-18 times of water for the 2 nd time, and extracting for 1.0-1.5 hr; adding 8-15 times of water for 3 times, extracting for 0.5-1.0 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to 3-6 times g/mL of folium Artemisiae Argyi, and filtering;
the belvedere fruit extracting solution is prepared by the following method:
weighing appropriate amount of Kochia scoparia, soaking in water for 0.2-0.8h, heating and reflux extracting for 3 times: adding 16-20 times of water for the first time, and extracting for 1.5-2.5 hr; adding 12-16 times of water for the 2 nd time, and extracting for 1.0-1.5 hr; adding 8-12 times of water for 3 times, extracting for 1.0-1.5 hr, filtering each time to obtain filtrate, mixing filtrates, concentrating the filtrate to volume of 2-4 times g/mL of Kochiae fructus, and filtering to obtain the final product;
the impatiens balsamina extract is prepared by the following method:
weighing appropriate amount of flos Impatientis, cutting into pieces, soaking in 75% ethanol for 0.4-0.6 hr, heating and reflux extracting for 3 times: adding 18-20 times of 75% ethanol for 1 time, and extracting for 1.0-2.0 hr; adding 14-18 times of 75% ethanol for 2 times, and extracting for 1.0-1.5 hr; adding 8-12 times of 75% ethanol for 3 times, extracting for 0.5-1.0 hr, filtering each time to obtain filtrate, mixing filtrates, vacuum distilling and concentrating to 6-8 times g/mL of flos Impatientis, and filtering to obtain final product.
2. A method for preparing the anti-inflammatory and antibacterial gel for treating onychomycosis according to claim 1, comprising the steps of:
a) weighing 0.1-1.0g of hydroxypropyl methylcellulose, adding into 20.0-35.0mL of distilled water, standing overnight to fully swell and dissolve to obtain hydroxypropyl methylcellulose gel solution for later use;
b) weighing 0.1-1.0g of sodium carboxymethylcellulose, adding into 30.0-60.0mL of distilled water, standing overnight to fully swell and dissolve the sodium carboxymethylcellulose, and obtaining sodium carboxymethylcellulose gel liquid for later use;
c) weighing 0.05-0.5g of miconazole nitrate, adding the miconazole nitrate into 0.4-2.3mL of 75% ethanol, standing and fully dissolving the miconazole nitrate to obtain miconazole nitrate solution for later use;
d) weighing 0.05-0.5g of urea, adding into 2.0-5.0mL of distilled water, heating in water bath at 60-70 ℃, stirring while heating, and fully dissolving to obtain a urea solution for later use;
e) respectively measuring 0.2-1.0mL of garlic extract, 0.3-1.5mL of sophora flavescens extract, 0.3-1.6mL of garden balsam stem extract, 0.2-1.2mL of pepper extract, 0.3-1.7mL of radix stemonae extract, 0.3-2.0mL of folium artemisiae argyi extract, 0.2-1.8mL of fructus kochiae extract and 0.3-1.5mL of garden balsam extract, and stirring and mixing uniformly to obtain a mixed solution 1 for later use;
f) respectively weighing 0.1-1.0g of azone, 1.5-3.0g of glycerol, 0.2-1.0g of aloe oil and 0.05-0.5g of sea buckthorn fruit oil, and stirring to uniformly mix to obtain a mixed solution 2 for later use;
g) weighing methyl hydroxybenzoate 0.01-0.08g and ethylparaben 0.01-0.08g, respectively, adding 75% ethanol 0.5-1.0mL, stirring to dissolve to obtain antiseptic solution;
h) mixing hydroxypropyl methylcellulose gel solution, sodium carboxymethylcellulose gel solution, miconazole nitrate solution, urea solution, mixed solution 1, mixed solution 2 and antiseptic solution, stirring, adding 0.2-1.5mL of white vinegar, and stirring to obtain the gel for treating onychomycosis.
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CN110833574A (en) * 2018-08-16 2020-02-25 安徽世龙生物医药科技有限公司 External preparation and preparation method thereof
CN111658722B (en) * 2020-06-22 2022-01-18 广东省微生物研究所(广东省微生物分析检测中心) External traditional Chinese medicine lotion for preventing and treating onychomycosis and preparation method thereof

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CN104922267A (en) * 2015-05-26 2015-09-23 赵武斌 Traditional Chinese medicine preparation for treating tinea of feet and hands and tinea unguium

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CN104434740A (en) * 2014-12-16 2015-03-25 皖南医学院 Traditional Chinese medicine gel for removing acnes and preparation method of traditional Chinese medicine gel
CN104922267A (en) * 2015-05-26 2015-09-23 赵武斌 Traditional Chinese medicine preparation for treating tinea of feet and hands and tinea unguium

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CN114796338A (en) * 2022-05-07 2022-07-29 绍兴百立康医疗科技有限公司 Gel for treating onychomycosis and preparation method thereof
CN114796338B (en) * 2022-05-07 2023-11-03 绍兴百立康医疗科技有限公司 Gel for treating onychomycosis and preparation method thereof

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