CN114796338A - Gel for treating onychomycosis and preparation method thereof - Google Patents

Gel for treating onychomycosis and preparation method thereof Download PDF

Info

Publication number
CN114796338A
CN114796338A CN202210489313.2A CN202210489313A CN114796338A CN 114796338 A CN114796338 A CN 114796338A CN 202210489313 A CN202210489313 A CN 202210489313A CN 114796338 A CN114796338 A CN 114796338A
Authority
CN
China
Prior art keywords
gel
parts
solution
ethanol
extract
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN202210489313.2A
Other languages
Chinese (zh)
Other versions
CN114796338B (en
Inventor
徐佳南
周惠慧
刘丽丽
包一丰
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shaoxing Bailikang Medical Technology Co ltd
Original Assignee
Shaoxing Bailikang Medical Technology Co ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shaoxing Bailikang Medical Technology Co ltd filed Critical Shaoxing Bailikang Medical Technology Co ltd
Priority to CN202210489313.2A priority Critical patent/CN114796338B/en
Publication of CN114796338A publication Critical patent/CN114796338A/en
Application granted granted Critical
Publication of CN114796338B publication Critical patent/CN114796338B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/60Salicylic acid; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/17Amides, e.g. hydroxamic acids having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/22Boron compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/489Sophora, e.g. necklacepod or mamani
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/75Rutaceae (Rue family)
    • A61K36/756Phellodendron, e.g. corktree
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10Antimycotics
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biotechnology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Botany (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Organic Chemistry (AREA)
  • Medical Informatics (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

The invention belongs to the technical field of onychomycosis, and particularly relates to gel for treating onychomycosis and a preparation method thereof. The invention overcomes the defects of the existing gel, and utilizes the matching of the organic solvent and water, thereby not only achieving the purposes of carrying active substances to carry out permeation sterilization and bacteriostasis, but also promoting the internal and external absorption of the active substances, and achieving the purposes of promoting metabolism, relieving symptoms and treating onychomycosis.

Description

Gel for treating onychomycosis and preparation method thereof
Technical Field
The invention belongs to the technical field of onychomycosis, and particularly relates to a gel for treating onychomycosis and a preparation method thereof.
Background
Onychomycosis is caused by dermatophyte invading the nail plate, the incidence rate of the onychomycosis accounts for more than 10% of superficial mycosis, the disease is common, the disease course is long, the pathological changes are stubborn and have infectivity. The nails become thick, brittle, loose and empty after infection; the surface is black, yellow, grey, white and the like, and particularly, the surface is suitable for the growth environment of fungi in areas with high air humidity and has higher morbidity
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. The penetration of the external medicine to the nail plate is poor, and the external medicine cannot penetrate through the protective layer on the surface of the nail and penetrate to the nail or the deep layer of the nail plate to kill the fungi, so that the medicine after being used has the advantages of unobvious curative effect, slow effect taking, short drug effect time, difficult cure and easy relapse. Therefore, there is a need in the market for a drug for external use which is excellent in therapeutic effect and high in safety.
Disclosure of Invention
Aiming at the problems in the prior art, the invention provides a gel for treating onychomycosis, which overcomes the defects of the existing gel, and not only can carry active substances to carry out osmotic sterilization and bacteriostasis, but also can promote the internal and external absorption of the active substances by utilizing the matching of an organic solvent and water, thereby achieving the purposes of promoting metabolism, relieving symptoms and treating onychomycosis.
In order to achieve the technical purpose, the technical scheme of the invention is as follows:
a gel for treating onychomycosis is prepared from salicylic acid, boric acid, Alumen, radix Sophorae Flavescentis extract, cortex Phellodendri, urea as functional materials, ZEN and SUNYUNSHIJIAO as thickening agent, and propylene glycol, purified water and ethanol water as solvent.
The gel comprises the following components in percentage by mass:
5-8 parts of salicylic acid, 2-6 parts of boric acid, 5-8 parts of alum, 3-7 parts of a sophora flavescens extract, 4-8 parts of golden cypress, 2-4 parts of urea, 5-10 parts of ZEN, 5-10 parts of corium versicolor, 10-20 parts of propylene glycol, 30-50 parts of purified water and 30-50 parts of an ethanol water solution.
The volume concentration of ethanol in the ethanol water solution is 70%.
The salicylic acid is a fat-soluble organic acid, exists in willow bark, beautyberry leaf and Betula platyphylla in nature, and has the effects of relieving itching, relieving swelling, alleviating pain and diminishing inflammation. Meanwhile, salicylic acid has good solubility in ethanol, and a good dispersion system is formed.
The boric acid can be used as an antiseptic and disinfectant, and has good bacteriostatic and antibacterial effects.
The alum is also called aluminum potassium sulfate dodecahydrate, is a double salt of potassium sulfate and aluminum sulfate containing crystal water, is soluble in water, has the giao functions of detoxifying, killing insects, eliminating dampness, relieving itching, stopping bleeding, relieving diarrhea, clearing heat and eliminating phlegm, and shows good antibacterial action and astringency when in use.
The sophora flavescens extract is obtained by extracting dry sophora flavescens, and the sophora flavescens extract not only has the functions of resisting virus, resisting allergy and the like, but also has good pathogen inhibition effect. The extraction method of the sophora flavescens extract comprises the following steps: a1, cleaning commercially available dried radix Sophorae Flavescentis with distilled water, air drying, and dicing to obtain radix Sophorae Flavescentis blocks; a2, adding the sophora flavescens blocks into an ethanol water solution, stirring and extruding to crush for 1-3h, then adding acetone and carrying out ultrasonic reaction for 2-4h to obtain a mixed suspension; the ethanol volume concentration of the ethanol aqueous solution is 60-70%, the mass ratio of the sophora flavescens blocks to the ethanol aqueous solution is 2-3:3, the extrusion crushing temperature is 30-50 ℃, the extrusion pressure is 0.3-0.5MPa, the addition amount of the acetone is 200-400% of the volume of the ethanol aqueous solution, and the ultrasonic reaction temperature is 30-40 ℃; in the step, the sophora flavescens block is soaked in an ethanol water solution to form swelling, and is crushed in the extrusion process, so that the exposed area is enhanced, the sophora flavescens block is ensured to be adsorbed and saturated to form swelling, only the dissolution characteristics of ethanol and water are realized, and the swelling and cracking of the dried sophora flavescens are matched, so that the dissolution effect is improved; with the addition of acetone, the matrine can directly act on sophora flavescens cells based on the fact that acetone has good intersolubility in water and ethanol, so that dissolution based on different organic solvents is formed; a3, carrying out gradient distillation on the mixed suspension, recovering ethanol and acetone to obtain a primary extract, carrying out acidification treatment on the primary extract for 2-3h, and filtering to obtain a filtrate, wherein hydrochloric acid is adopted as an acidifier in the acidification treatment, and the pH of the acidification treatment is 3-4; a4, adjusting the pH of the filtrate to 9-10 by using alkali liquor, filtering, and then distilling under reduced pressure to obtain a paste, wherein the alkali liquor is ammonia water, the temperature of the distillation under reduced pressure is 90-100 ℃, and the pressure is 80-90% of the atmospheric pressure; removing substances by means of acidification and alkalization, finally forming a paste mainly in an alkali state, simultaneously directly taking out solutes of hydrochloric acid and ammonia water which are volatile substances in reduced pressure distilled water, so as to ensure that the solutes do not form residues, a5, dissolving the paste in acetone, performing heat filtration, drying, adding petroleum ether, filtering, standing to obtain crystals, wherein the temperature of the heat filtration is 30-40 ℃, and removing impurities by means of dissolution filtration to form a compound extract mainly containing oxymatrine and matrine; the radix Sophorae Flavescentis extract obtained by this method has matrine as main ingredient, and oxymatrine as auxiliary ingredient, and has antibacterial and bacteriostatic effects and properties of both. In order to improve the purity of matrine in the crystal, putting the crystal into diethyl ether, performing ultrasonic treatment for 20-30min, filtering, and spray drying the filtrate to obtain matrine granule; the ultrasonic frequency is 40-50kHz, the temperature is 5-10 ℃, and the spray drying temperature is 40 ℃.
The cortex Phellodendri is cortex Phellodendri extract, and is extracted from bark of cortex Phellodendri. Cortex Phellodendri extract has effects of removing toxic substance and treating sore, and can be applied into nail rapidly. The extraction method of the golden cypress comprises the following steps: b1, cleaning and fastening the surface of the bark of the phellodendron amurense, then putting the phellodendron amurense into an ethanol water solution for soaking until the phellodendron amurense is completely softened, and crushing the phellodendron amurense to obtain suspension; the volume concentration of ethanol in the ethanol water solution is 30-40%, the soaking temperature is 25-45 ℃, and the pulverization is mechanically pulverized into filaments; b2, placing the suspension into a reaction kettle, hermetically cooking for 1-2h, cooling, and performing filter pressing to obtain filtrate, wherein the temperature of the hermetic cooking is 100-110 ℃, the pressure of the filter pressing is 0.3-0.5MPa, and the cooking mode can convert ethanol and water into a steam state to form a permeation effect, so that bark cells are opened, the effect of curing and diffusion is achieved, the liquid permeability is improved, and the problem of obstruction of cell walls is reduced; after cooling, substances in the bark are fully dissolved out, and most of removal effect is realized in filter pressing; b3, distilling the filtrate under reduced pressure to remove ethanol, and cooling and drying to obtain cortex Phellodendri extract, wherein the temperature of the distillation under reduced pressure is 70-80 deg.C, and the pressure is 80-90% of atmospheric pressure. The process utilizes a soaking and softening mode to completely absorb water and saturate bark, ensures that bark cells form a swelling effect, converts water and ethanol in a swelling system into steam in a cooking process, breaks cell walls to achieve the purpose of opening, provides a dissolution path for dissolution after subsequent cooling, and improves the dissolution effect.
The urea has good moisture retention and can effectively improve local humidity.
ZEN is ZEN from gathering the polymer, belongs to polyacrylic acid thickener, has good thickening effect.
The Caesalpinia crista gum belongs to a thickening agent and can play a role in thickening and improving water solubility.
The preparation method of the gel for treating the onychomycosis comprises the following steps:
step 1, heating ZEN, subcloud shell gum, propylene glycol and purified water to 60-70 ℃, and stirring for dissolving for 5min to obtain a first dissolved solution;
step 2, heating boric acid, alum, a radix sophorae flavescentis extract, golden cypress, urea and purified water to 60-70 ℃, and stirring for dissolving for 5min to obtain a second dissolved solution;
dissolving salicylic acid in an ethanol water solution at normal temperature to obtain a third dissolved solution, wherein the volume concentration of ethanol in the ethanol water solution is 70%;
step 4, uniformly mixing the first solution, the second solution and the third solution, stirring for 4 hours to form gel, namely the product
The gel is applied to the surface of the onychomycosis by adopting a wet wrapping mode.
In the use, propylene glycol, ethanol and water all have good flat effect of pasting, not only form complete the application on the onychomycosis surface, and self permeability and solubility can inwards permeate active substance, realize the effect of inside and outside absorption to reach the effect of strengthening metabolism, alum, boric acid, salicylic acid are the material formation antibacterial system that disinfects fast simultaneously, realize detumescence and diminish inflammation on nontoxic nonirritant basis.
From the above description, it can be seen that the present invention has the following advantages:
1. the invention overcomes the defects of the existing gel, and utilizes the matching of the organic solvent and water, thereby not only achieving the purposes of carrying active substances to carry out permeation sterilization and bacteriostasis, but also promoting the internal and external absorption of the active substances, and achieving the purposes of promoting metabolism, relieving symptoms and treating onychomycosis.
2. The invention utilizes ZEN and Caesalpinia crista gum to form the composite thickening agent, and is matched with multiple-effect debridement of different solvent systems, so that the wound surface is quickly cleaned, and the healing of the wound surface is facilitated.
3. The invention adopts the soluble salicylic acid to form the salicylic acid solution, thereby not only effectively improving the action surface of the salicylic acid and solving the problem of poor salicylic acid utilization rate, but also greatly improving the salicylic acid utilization rate by the salicylic acid forming a penetration effect along with the solvent.
Detailed Description
The present invention is described in detail with reference to examples, but the present invention is not limited to the claims.
Example 1
A gel for treating onychomycosis is prepared from salicylic acid, boric acid, Alumen, radix Sophorae Flavescentis extract, cortex Phellodendri, urea as functional materials, ZEN and SUNYUNSHIJIAO as thickening agent, and propylene glycol, purified water and ethanol water as solvent.
The gel comprises the following components in percentage by mass:
5 parts of salicylic acid, 2 parts of boric acid, 5 parts of alum, 3 parts of radix sophorae flavescentis extract, 4 parts of cortex phellodendri, 2-4 parts of urea, 5 parts of ZEN, 5 parts of corium versicolor, 10 parts of propylene glycol, 30 parts of purified water and 30-50 parts of ethanol water solution.
The volume concentration of ethanol in the ethanol water solution is 70%.
The radix Sophorae Flavescentis extract is obtained by extracting dried radix Sophorae Flavescentis. The extraction method of the sophora flavescens extract comprises the following steps: a1, cleaning commercially available dried radix Sophorae Flavescentis with distilled water, air drying, and dicing to obtain radix Sophorae Flavescentis blocks; a2, adding the sophora flavescens blocks into an ethanol water solution, stirring and extruding to crush for 1h, then adding acetone and carrying out ultrasonic reaction for 2h to obtain a mixed suspension; the ethanol volume concentration of the ethanol aqueous solution is 60%, the mass ratio of the sophora flavescens blocks to the ethanol aqueous solution is 2:3, the extrusion crushing temperature is 30 ℃, the extrusion pressure is 0.3MPa, the addition amount of acetone is 200% of the volume of the ethanol aqueous solution, and the ultrasonic reaction temperature is 30 ℃; a3, carrying out gradient distillation on the mixed suspension, recovering ethanol and acetone to obtain a primary extract, carrying out acidification treatment on the primary extract for 2 hours, and filtering to obtain a filtrate, wherein hydrochloric acid is adopted as an acidifying agent in the acidification treatment, and the pH of the acidification treatment is 3; a4, adjusting the pH value of the filtrate to 9 by using alkali liquor, filtering, distilling under reduced pressure to obtain paste, wherein the alkali liquor adopts ammonia water, the temperature of the reduced pressure distillation is 90 ℃, and the pressure is 80% of the atmospheric pressure, a5, dissolving the paste in acetone, carrying out heat filtration, drying, adding petroleum ether, filtering, standing to obtain crystals, and the temperature of the heat filtration is 30 ℃. In order to improve the purity of matrine in the crystal, putting the crystal into ether, performing ultrasonic treatment for 20min, filtering, and spray drying the filtrate to obtain matrine granules; the ultrasonic frequency is 40kHz, the temperature is 5 ℃, and the spray drying temperature is 40 ℃.
The cortex Phellodendri is cortex Phellodendri extract, and is extracted from bark of cortex Phellodendri. The extraction method of the golden cypress comprises the following steps: b1, cleaning and fastening the surface of the bark of the phellodendron amurense, then putting the phellodendron amurense into an ethanol water solution for soaking until the phellodendron amurense is completely softened, and crushing the phellodendron amurense to obtain suspension; the volume concentration of ethanol in the ethanol water solution is 30%, the soaking temperature is 25 ℃, and the pulverization is mechanically pulverized into filaments; b2, placing the suspension into a reaction kettle, sealing, cooking and boiling for 1h, cooling, and performing filter pressing to obtain filtrate, wherein the sealing, cooking and boiling temperature is 100 ℃, and the filter pressing pressure is 0.3 MPa; b3, distilling the filtrate under reduced pressure to remove ethanol, and cooling and drying to obtain cortex Phellodendri extract, wherein the temperature of the distillation under reduced pressure is 70 deg.C, and the pressure is 80% of atmospheric pressure.
The preparation method of the gel for treating the onychomycosis comprises the following steps:
step 1, heating ZEN, subcloud shell gum, propylene glycol and purified water to 60 ℃, and stirring for dissolving for 5min to obtain a first dissolved solution;
step 2, heating boric acid, alum, a radix sophorae flavescentis extract, golden cypress, urea and purified water to 60 ℃, and stirring for dissolving for 5min to obtain a second dissolved solution;
dissolving salicylic acid in an ethanol water solution at normal temperature to obtain a third dissolved solution;
step 4, uniformly mixing the first solution, the second solution and the third solution, stirring for 4 hours to form gel, namely the product
The gel is applied to the surface of the onychomycosis by adopting a wet wrapping mode.
Example 2
A gel for treating onychomycosis is prepared from salicylic acid, boric acid, Alumen, radix Sophorae Flavescentis extract, cortex Phellodendri, urea as functional materials, ZEN and SUNYUNSHIJIAO as thickening agent, and propylene glycol, purified water and ethanol water as solvent.
The gel comprises the following components in percentage by mass:
8 parts of salicylic acid, 6 parts of boric acid, 8 parts of alum, 7 parts of radix sophorae flavescentis extract, 8 parts of golden cypress, 4 parts of urea, 10 parts of ZEN, 10 parts of coriaria sinica gum, 20 parts of propylene glycol, 50 parts of purified water and 50 parts of ethanol water solution.
The volume concentration of ethanol in the ethanol water solution is 70%.
The radix Sophorae Flavescentis extract is obtained by extracting dried radix Sophorae Flavescentis. The extraction method of the sophora flavescens extract comprises the following steps: a1, cleaning commercially available dried radix sophorae flavescentis by using distilled water, drying in the air and dicing to obtain radix sophorae flavescentis blocks; a2, adding the sophora flavescens blocks into an ethanol water solution, stirring and extruding to crush for 3 hours, then adding acetone and carrying out ultrasonic reaction for 4 hours to obtain a mixed suspension; the ethanol volume concentration of the ethanol aqueous solution is 70%, the mass ratio of the sophora flavescens blocks to the ethanol aqueous solution is 3:3, the extrusion crushing temperature is 50 ℃, the extrusion pressure is 0.5MPa, the addition amount of acetone is 400% of the volume of the ethanol aqueous solution, and the ultrasonic reaction temperature is 40 ℃; a3, carrying out gradient distillation on the mixed suspension, recovering ethanol and acetone to obtain a primary extract, then carrying out acidification treatment on the primary extract for 3 hours, and filtering to obtain a filtrate, wherein hydrochloric acid is adopted as an acidifying agent in the acidification treatment, and the pH value of the acidification treatment is 4; a4, adjusting the pH value of the filtrate to 10 by using alkali liquor, filtering, distilling under reduced pressure to obtain paste, wherein the alkali liquor adopts ammonia water, the temperature of the reduced pressure distillation is 100 ℃, the pressure is 90% of the atmospheric pressure, a5, the paste is put into acetone to be dissolved and filtered, petroleum ether is added after drying, filtering is carried out, standing is carried out to obtain crystals, and the temperature of the heat filtering is 40 ℃. In order to improve the purity of matrine in the crystal, putting the crystal into ether, performing ultrasonic treatment for 30min, filtering, and spray drying the filtrate to obtain matrine granules; the ultrasonic frequency is 50kHz, the temperature is 10 ℃, and the spray drying temperature is 40 ℃.
The cortex Phellodendri is cortex Phellodendri extract, and is extracted from bark of cortex Phellodendri. The extraction method of the golden cypress comprises the following steps: b1, cleaning and fastening the surface of the bark of the phellodendron amurense, then putting the phellodendron amurense into an ethanol water solution for soaking until the phellodendron amurense is completely softened, and crushing the phellodendron amurense to obtain suspension; the volume concentration of ethanol in the ethanol water solution is 40%, the soaking temperature is 45 ℃, and the pulverization is mechanically pulverized into filaments; b2, placing the suspension into a reaction kettle, sealing, cooking for 2 hours, cooling, and performing filter pressing to obtain filtrate, wherein the sealing, cooking temperature is 110 ℃, and the pressure of the filter pressing is 0.5 MPa; b3, distilling the filtrate under reduced pressure to remove ethanol, and cooling and drying to obtain cortex Phellodendri extract, wherein the temperature of the distillation under reduced pressure is 80 deg.C, and the pressure is 90% of atmospheric pressure.
The preparation method of the gel for treating the onychomycosis comprises the following steps:
step 1, heating ZEN, subcloud shell gum, propylene glycol and purified water to 70 ℃, and stirring for dissolving for 5min to obtain a first dissolved solution;
step 2, heating boric acid, alum, a radix sophorae flavescentis extract, golden cypress, urea and purified water to 70 ℃, and stirring for dissolving for 5min to obtain a second dissolved solution;
step 3, dissolving salicylic acid in an ethanol water solution at normal temperature to obtain a third dissolved solution,
step 4, uniformly mixing the first solution, the second solution and the third solution, stirring for 4 hours to form gel, namely the product
The gel is applied to the surface of the onychomycosis by adopting a wet wrapping mode.
Example 3
A gel for treating onychomycosis is prepared from salicylic acid, boric acid, Alumen, radix Sophorae Flavescentis extract, cortex Phellodendri, urea as functional materials, ZEN and SUNYUNSHIJIAO as thickening agent, and propylene glycol, purified water and ethanol water as solvent.
The gel comprises the following components in percentage by mass:
7 parts of salicylic acid, 5 parts of boric acid, 5 parts of alum, 5 parts of a sophora flavescens extract, 7 parts of golden cypress, 3 parts of urea, 8 parts of ZEN, 8 parts of coriaria sinica gum, 15 parts of propylene glycol, 50 parts of purified water and 50 parts of ethanol water solution.
The volume concentration of ethanol in the ethanol water solution is 70%.
The radix Sophorae Flavescentis extract is obtained by extracting dried radix Sophorae Flavescentis. The extraction method of the sophora flavescens extract comprises the following steps: a1, cleaning commercially available dried radix Sophorae Flavescentis with distilled water, air drying, and dicing to obtain radix Sophorae Flavescentis blocks; a2, adding the sophora flavescens blocks into an ethanol water solution, stirring and extruding to crush for 2 hours, then adding acetone and carrying out ultrasonic reaction for 3 hours to obtain a mixed suspension; the ethanol volume concentration of the ethanol aqueous solution is 65%, the mass ratio of the sophora flavescens blocks to the ethanol aqueous solution is 2:3, the extrusion crushing temperature is 40 ℃, the extrusion pressure is 0.4MPa, the addition amount of acetone is 300% of the volume of the ethanol aqueous solution, and the ultrasonic reaction temperature is 35 ℃; a3, carrying out gradient distillation on the mixed suspension, recovering ethanol and acetone to obtain a primary extract, carrying out acidification treatment on the primary extract for 2 hours, and filtering to obtain a filtrate, wherein hydrochloric acid is adopted as an acidifying agent in the acidification treatment, and the pH of the acidification treatment is 3; a4, adjusting the pH value of the filtrate to 10 by using alkali liquor, filtering, distilling under reduced pressure to obtain paste, wherein the alkali liquor adopts ammonia water, the temperature of the reduced pressure distillation is 90 ℃, and the pressure is 80% of the atmospheric pressure, a5, dissolving the paste in acetone, carrying out heat filtration, drying, adding petroleum ether, filtering, standing to obtain crystals, and the temperature of the heat filtration is 35 ℃. In order to improve the purity of matrine in the crystal, putting the crystal into diethyl ether, performing ultrasonic treatment for 25min, filtering, and spray drying the filtrate to obtain matrine granule; the ultrasonic frequency is 45kHz, the temperature is 5 ℃, and the spray drying temperature is 40 ℃.
The cortex Phellodendri is cortex Phellodendri extract, and is extracted from bark of cortex Phellodendri. The extraction method of the golden cypress comprises the following steps: b1, cleaning and fastening the surface of the bark of the phellodendron amurense, then putting the phellodendron amurense into an ethanol water solution for soaking until the phellodendron amurense is completely softened, and crushing the phellodendron amurense to obtain suspension; the volume concentration of ethanol in the ethanol water solution is 30-40%, the soaking temperature is 40 ℃, and the pulverization is mechanically pulverized into filaments; b2, placing the suspension into a reaction kettle, sealing, cooking for 2 hours, cooling, and performing filter pressing to obtain filtrate, wherein the sealing, cooking temperature is 105 ℃, and the pressure of the filter pressing is 0.4 MPa; b3, distilling the filtrate under reduced pressure to remove ethanol, and cooling and drying to obtain cortex Phellodendri extract, wherein the temperature of the distillation under reduced pressure is 75 deg.C, and the pressure is 85% of atmospheric pressure.
The preparation method of the gel for treating the onychomycosis comprises the following steps:
step 1, heating ZEN, subcloud shell gum, propylene glycol and purified water to 65 ℃, and stirring for dissolving for 5min to obtain a first dissolved solution;
step 2, heating boric acid, alum, a sophora flavescens extract, phellodendron, urea and purified water to 65 ℃, and stirring for dissolving for 5min to obtain a second dissolved solution;
dissolving salicylic acid in an ethanol water solution at normal temperature to obtain a third dissolved solution, wherein the volume concentration of ethanol in the ethanol water solution is 70%;
step 4, uniformly mixing the first solution, the second solution and the third solution, stirring for 4 hours to form gel, namely the product
The gel is applied to the surface of the onychomycosis by adopting a wet wrapping mode.
The following tests were carried out using the products of examples 1 to 3 described above as test examples:
1. the product is fine and uniform, and has good absorbability and spreadability.
2. The pH value of the product is about 7.
3. The gel was packed in a sealed bottle and no foreign body was found neither by freezing (-5 ℃) nor by temperature (50 ℃).
4. 100 onychomycosis patients aged 15 to 65 years were selected, with the following main symptoms: diseased nails are brown, grayish brown or dark brown, and thickened and embrittled nail plates, or hollow middle layers of nail plates, uneven nail margins, incomplete nail plates and the like can be seen. Randomized into 3 groups of 20 people each. Each group is coated with the gel prepared in examples 1-3 for 30min, and is administered once in the morning and at night, with 30 days as a treatment course, and 4 treatment courses are total. The ashed nails were shaved with a knife before application and every other week during treatment.
Statistics shows that the total effective rate of the product in the example 1 is 100%, and the significant effect proportion is 70%. The total effective rate of the product of example 2 is 100%, and the significant effective rate is 85%. The total effective rate of the product of example 3 is 100%, and the proportion of significant effects is 75%.
The nail polish has the obvious effects that the surface fungus detection is negative, the nail color is normal and glossy, the surface fullness fungus detection is positive, and the color of the newly born nail is slightly different, glossy and poor in glossiness. Ineffectiveness is no apparent change before and after use.
It should be understood that the detailed description of the invention is merely illustrative of the invention and is not intended to limit the invention to the specific embodiments described. It will be appreciated by those skilled in the art that the present invention may be modified or substituted equally as well to achieve the same technical result; as long as the use requirements are met, the method is within the protection scope of the invention.

Claims (7)

1. A gel for treating onychomycosis, comprising: salicylic acid, boric acid, alum, a radix sophorae flavescentis extract, golden cypress and urea are used as functional materials, ZEN and corium versicolor are used as thickening agents, and propylene glycol, purified water and an ethanol water solvent are used as solvents.
2. The gel for treating onychomycosis according to claim 1, wherein: the gel comprises the following components in percentage by mass:
5-8 parts of salicylic acid, 2-6 parts of boric acid, 5-8 parts of alum, 3-7 parts of a sophora flavescens extract, 4-8 parts of golden cypress, 2-4 parts of urea, 5-10 parts of ZEN, 5-10 parts of corium versicolor, 10-20 parts of propylene glycol, 30-50 parts of purified water and 30-50 parts of an ethanol water solution.
3. The gel for treating onychomycosis according to claim 1, wherein: the volume concentration of ethanol in the ethanol water solution is 70%.
4. The gel for treating onychomycosis according to claim 1, wherein: the radix Sophorae Flavescentis extract is obtained by extracting dried radix Sophorae Flavescentis.
5. The gel for treating onychomycosis according to claim 1, wherein: the cortex Phellodendri is cortex Phellodendri extract, and is extracted from bark of cortex Phellodendri.
6. The gel for treating onychomycosis according to claim 1, wherein: the preparation method of the gel for treating the onychomycosis comprises the following steps:
step 1, heating ZEN, Caesalpinia crista gum, propylene glycol and purified water to 60-70 ℃, and stirring and dissolving for 5min to obtain a first dissolved solution;
step 2, heating boric acid, alum, a radix sophorae flavescentis extract, golden cypress, urea and purified water to 60-70 ℃, and stirring for dissolving for 5min to obtain a second dissolved solution;
dissolving salicylic acid in an ethanol water solution at normal temperature to obtain a third dissolved solution, wherein the volume concentration of ethanol in the ethanol water solution is 70%;
and 4, uniformly mixing the first solution, the second solution and the third solution, and stirring for 4 hours to form a gel, namely the product.
7. The gel for treating onychomycosis according to claim 1, wherein: the gel is applied to the surface of the onychomycosis by adopting a wet wrapping mode.
CN202210489313.2A 2022-05-07 2022-05-07 Gel for treating onychomycosis and preparation method thereof Active CN114796338B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202210489313.2A CN114796338B (en) 2022-05-07 2022-05-07 Gel for treating onychomycosis and preparation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202210489313.2A CN114796338B (en) 2022-05-07 2022-05-07 Gel for treating onychomycosis and preparation method thereof

Publications (2)

Publication Number Publication Date
CN114796338A true CN114796338A (en) 2022-07-29
CN114796338B CN114796338B (en) 2023-11-03

Family

ID=82512320

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202210489313.2A Active CN114796338B (en) 2022-05-07 2022-05-07 Gel for treating onychomycosis and preparation method thereof

Country Status (1)

Country Link
CN (1) CN114796338B (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115778877A (en) * 2022-12-19 2023-03-14 北京同仁堂麦尔海生物技术有限公司 Acne removing composition

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101664379A (en) * 2009-09-22 2010-03-10 南京白敬宇制药有限责任公司 Salicylic acid gelling agent and preparation method thereof
CN105267866B (en) * 2015-11-04 2019-03-12 皖南医学院 A kind of emulsion and preparation method thereof for treating onychomycosis
CN107496792B (en) * 2017-08-29 2020-05-26 皖南医学院 Gel for treating onychomycosis by diminishing inflammation and resisting bacteria and preparation method thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101664379A (en) * 2009-09-22 2010-03-10 南京白敬宇制药有限责任公司 Salicylic acid gelling agent and preparation method thereof
CN105267866B (en) * 2015-11-04 2019-03-12 皖南医学院 A kind of emulsion and preparation method thereof for treating onychomycosis
CN107496792B (en) * 2017-08-29 2020-05-26 皖南医学院 Gel for treating onychomycosis by diminishing inflammation and resisting bacteria and preparation method thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115778877A (en) * 2022-12-19 2023-03-14 北京同仁堂麦尔海生物技术有限公司 Acne removing composition

Also Published As

Publication number Publication date
CN114796338B (en) 2023-11-03

Similar Documents

Publication Publication Date Title
CN105688166A (en) Medical cold compress paster and preparation method thereof
CN101062289A (en) External application medicine combination for treating gout
CN106975095B (en) Antibacterial medical auxiliary material and preparation method thereof
CN114796338B (en) Gel for treating onychomycosis and preparation method thereof
CN111467433B (en) A topical Chinese medicinal composition and paste for promoting wound healing, and its preparation method
CN109833412A (en) A kind of hemorrhoid wet tissue and preparation method thereof
CN105125408A (en) Preparation method and application of rhizome traditional Chinese medicinal material decocting-free preparation
CN111249362A (en) Traditional Chinese medicine composition and traditional Chinese medicine preparation for treating bedsore, diabetic foot, skin or mucosa wound and hemorrhoid and preparation method thereof
CN111248530A (en) Agalloch eaglewood gauze mask
CN112675354B (en) Multifunctional rhizoma bletillae medical material and preparation method and application thereof
CN101491609A (en) Burn and scald treatment preparation and preparation method thereof
CN102940777A (en) Cough relieving and sore-throat relieving cataplasm and preparation method thereof
CN106798817A (en) A kind of analgesia ointment production technology
CN103265493A (en) Desmodium sequax extractive, as well as extraction method and new application thereof
CN105998172A (en) Topical dressing for treating herpes zoster and preparation method thereof
CN108235684B (en) Traditional Chinese medicine patch for softening scars
CN108113916B (en) Natural repair peptide mask liquid and preparation method thereof
CN110585278A (en) Health-care vinasse applying mud and preparation method thereof
CN111419920B (en) Medicine composition with hypoglycemic effect and preparation method and application thereof
AU2021105105A4 (en) Drug for treating esophageal squamous cell carcinoma, and preparation method and use thereof
CN109966310B (en) Sepiolite effervescent tablet and preparation method and application thereof
CN1927352A (en) Externally used traditional Chinese medicine preparation for treating nasal mucosa erosion and nosebleed and its preparation method
CN108403870A (en) A kind of the membrane of a chicken&#39;s gizzard spray-filming agent for treating canker sore
KR20080074067A (en) Manufacturing method and that extract of the extract which does the pylora japonica with the principal ingredient
CN1189188C (en) Leukoderma curing plaster

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant