CN111450212A - A Chinese medicinal composition for treating tinea pedis and tinea, and preparation method thereof - Google Patents

A Chinese medicinal composition for treating tinea pedis and tinea, and preparation method thereof Download PDF

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CN111450212A
CN111450212A CN202010434920.XA CN202010434920A CN111450212A CN 111450212 A CN111450212 A CN 111450212A CN 202010434920 A CN202010434920 A CN 202010434920A CN 111450212 A CN111450212 A CN 111450212A
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parts
traditional chinese
chinese medicine
tinea
preparation
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贺莲
粟韬源
杨辉
朱上恒
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Honglin Biotechnology Guangzhou Co ltd
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Honglin Biotechnology Guangzhou Co ltd
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    • 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
    • A61K36/13Coniferophyta (gymnosperms)
    • A61K36/15Pinaceae (Pine family), e.g. pine or cedar
    • 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)
    • 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)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/234Cnidium (snowparsley)
    • 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)
    • A61K36/47Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
    • 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)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/534Mentha (mint)
    • 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)
    • 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
    • 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)
    • A61K36/83Thymelaeaceae (Mezereum family), e.g. leatherwood or false ohelo
    • 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)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • 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)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/90Smilacaceae (Catbrier family), e.g. greenbrier or sarsaparilla
    • 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)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/904Stemonaceae (Stemona family), e.g. croomia
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/12Aerosols; Foams
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH

Abstract

The invention provides a traditional Chinese medicine composition for treating beriberi and tinea and a preparation method thereof, belonging to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition for treating dermatophytosis and tinea provided by the invention comprises the following components in parts by weight: 10-30 parts of golden larch bark, 20-30 parts of golden cypress, 10-20 parts of common cnidium fruit, 15-30 parts of belvedere fruit, 10-20 parts of glabrous greenbrier rhizome, 5-10 parts of sessile stemona root, 10-20 parts of dittany bark, 10-20 parts of lightyellow sophora root, 10-20 parts of ilex rotundus, 10-20 parts of radix euphorbiae lantu and 5-10 parts of mint. The traditional Chinese medicine composition makes up the vacancy that the existing medicines on the market cannot treat beriberi and tinea at the same time, and has obvious curative effect on people suffering from various types of beriberi and tinea.

Description

A Chinese medicinal composition for treating tinea pedis and tinea, and preparation method thereof
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating beriberi and tinea and a preparation method thereof.
Background
Beriberi, an infectious skin disease caused by fungal infection, generally occurs first on one side (single foot) and reaches the contralateral side after several weeks of infection. At present, beriberi has the characteristic of high morbidity, and the clinical manifestations of the beriberi are desquamation, wet and soft skin and white hair, blisters among toes, even skin cracking, thickening, roughness and erosion, severe pruritus and spreadability. It may also be accompanied by other tinea such as local pain, red swelling, suppuration and serious inguinal lymph node, and serious patients may also cause secondary infection such as cellulitis and leg erysipelas. For the treatment of tinea pedis, the clinical application of wiping with ointment and the like generally has certain treatment effect, but the treatment effect is still not very obvious, and the recurrence rate is high, which is not enough to cure the root cause.
Disclosure of Invention
In view of the above, the present invention aims to provide a Chinese medicinal composition for treating tinea pedis and tinea and a preparation method thereof, wherein the Chinese medicinal composition has a significant curative effect on various tinea and tinea pedis groups.
The invention provides a traditional Chinese medicine composition for treating dermatophytosis and tinea, which comprises the following components in parts by weight: 10-30 parts of golden larch bark, 20-30 parts of golden cypress, 10-20 parts of common cnidium fruit, 15-30 parts of belvedere fruit, 10-20 parts of glabrous greenbrier rhizome, 5-10 parts of sessile stemona root, 10-20 parts of dittany bark, 10-20 parts of lightyellow sophora root, 10-20 parts of ilex rotundus, 10-20 parts of radix euphorbiae lantu and 5-10 parts of mint.
Preferably, the composition comprises the following components in parts by weight: 20 parts of golden larch bark, 25 parts of golden cypress, 16 parts of common cnidium fruit, 23 parts of belvedere fruit, 16 parts of glabrous greenbrier rhizome, 8 parts of sessile stemona root, 15 parts of dittany bark, 15 parts of lightyellow sophora root, 16 parts of ilex rotundus, 14 parts of radix euphorbiae lantu and 8 parts of mint.
Preferably, the beriberi comprises an impregnated intertrigo type, a blister type and a scaly cornification type.
Preferably, the tinea includes tinea cruris, tinea capitis, and tinea manuum.
The invention provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
1) sequentially pulverizing cortex pseudolaricis, cortex Phellodendri, fructus Cnidii, Kochiae fructus, rhizoma Smilacis Glabrae, radix Stemonae, cortex Dictamni Radicis, radix Sophorae Flavescentis, radix Ilicis Pubescentis, radix Euphorbiae Fischerianae and herba Menthae, sieving with 20 mesh sieve, and collecting coarse powder of Chinese medicinal materials;
2) carrying out superfine grinding and sterilization on the traditional Chinese medicine coarse powder to obtain the traditional Chinese medicine composition.
Preferably, the sterilized traditional Chinese medicine superfine powder also comprises subpackaging, granulating or tabletting.
Preferably, the granulating method comprises the steps of mixing water serving as a binding agent and sterilized traditional Chinese medicine superfine powder to prepare a soft material, sequentially granulating, drying, grading and subpackaging.
Preferably, the tabletting method comprises the steps of mixing 8-10 parts by mass of sterilized traditional Chinese medicine superfine powder, 3-4 parts by mass of citric acid and 3-4 parts by mass of sodium bicarbonate, granulating, tabletting and subpackaging.
Preferably, the preparation method also comprises the preparation of a traditional Chinese medicine composition spray;
heating and extracting the traditional Chinese medicine coarse powder by using an ethanol water solution with the volume concentration of 50-70%, wherein the heating and extracting temperature is 95-100 ℃; the volume ratio of the mass of the traditional Chinese medicine coarse powder to the ethanol water solution is 1g: 8-12 ml.
Preferably, the volume concentration of the ethanol water solution is 60%, and the temperature of the heating extraction is 100 ℃; the ratio of the mass of the traditional Chinese medicine coarse powder to the volume of the ethanol water solution is 1g to 10 ml.
The invention provides a traditional Chinese medicine composition for treating beriberi and tinea, which takes golden larch bark and golden cypress as monarch drugs, common cnidium fruit, belvedere fruit, glabrous greenbrier rhizome, sessile stemona root, densefruit pittany root-bark and lightyellow sophora root as ministerial drugs, and ferrum wintergreen, Chinese wolfsbane root and mint as adjuvant drugs, and jointly play roles of clearing heat and drying dampness, dispelling wind and relieving itching, detoxifying and killing insects, and inhibiting bacteria and killing bacteria to treat beriberi and tinea. The traditional Chinese medicine composition provided by the invention can be used for treating various tinea and beriberi, can be quickly cured and is not easy to relapse, the tinea can be cured after being taken for 2-3 times, shoes and socks do not need to be replaced aiming at various beriberi, and the defect that the existing products on the market can not be used for universal treatment of tinea pedis is overcome. For the treatment of various types of beriberi, the curative ratio and the total effective rate of an observed group are respectively 88.3 percent and 96.7 percent which are respectively obviously higher than those of a control group 63.3 percent and 81.7 percent by comparing the effects of a medicament treatment group and the control group after 15 days of treatment, and the difference has statistical significance (P is less than 0.05). For the treatment of various tinea, compared with the effect of the drug treatment group and the control group after 7 days, the cure rate and the total effective rate of the observation group are respectively 88.3 percent and 98.3 percent which are respectively obviously higher than 65 percent and 83.3 percent of the control group, and the difference has statistical significance (P is less than 0.05).
Drawings
Fig. 1 is a bacteriostatic activity evaluation report of the traditional Chinese medicine composition provided by the invention.
Detailed Description
The invention provides a traditional Chinese medicine composition for treating dermatophytosis and tinea, which comprises the following components in parts by weight: 10-30 parts of golden larch bark, 20-30 parts of golden cypress, 10-20 parts of common cnidium fruit, 15-30 parts of belvedere fruit, 10-20 parts of glabrous greenbrier rhizome, 5-10 parts of sessile stemona root, 10-20 parts of dittany bark, 10-20 parts of lightyellow sophora root, 10-20 parts of ilex rotundus, 10-20 parts of radix euphorbiae lantu and 5-10 parts of mint.
The traditional Chinese medicine composition provided by the invention comprises golden larch bark. The golden larch bark is preferably 12-25 parts by weight, and more preferably 20 parts by weight. The cortex pseudolaricis has antibacterial effect on Trichophyton schoenleinii, Epidermophyton floccosum, Microsporum ferrugineum, Microsporum gypseum and Candida albicans. The source of the golden larch bark is not particularly limited in the present invention, and golden larch bark known in the art can be used.
The traditional Chinese medicine composition provided by the invention comprises golden cypress. The phellodendron amurense is preferably 22 to 27 parts by weight, and more preferably 25 parts by weight. The cortex phellodendri plays the medicinal effects of clearing heat, removing toxicity, clearing heat and drying dampness, and is mainly used for scabies and skin eczema. The source of the phellodendron bark is not particularly limited in the present invention, and phellodendron bark known in the art can be used. The golden larch bark and the golden cypress are jointly used as monarch drugs to play roles in clearing heat, drying dampness, inhibiting bacteria and killing bacteria.
The traditional Chinese medicine composition provided by the invention comprises fructus cnidii. The common cnidium fruit is preferably 12-18 parts by weight, and more preferably 15 parts by weight. The fructus Cnidii has effects of eliminating dampness, dispelling pathogenic wind, and killing parasite, and can be used for treating leukorrhagia due to cold-dampness, lumbago due to damp arthralgia, eczema, pudendal pruritus of women, and trichomonas vaginitis. The source of the fructus cnidii is not particularly limited in the invention, and the fructus cnidii known in the field can be used.
The traditional Chinese medicine composition provided by the invention comprises belvedere fruit. The amount of the broom cypress fruit is preferably 18-26 parts by weight, and more preferably 23 parts by weight. The Kochiae fructus has effects of clearing heat, promoting diuresis, dispelling pathogenic wind and relieving itching, and can be used for treating urination pain, pruritus vulvae, leukorrhagia, rubella, eczema and skin pruritus. The source of the Kochia scoparia is not particularly limited in the present invention, and the Kochia scoparia known in the art can be used.
The traditional Chinese medicine composition provided by the invention comprises rhizoma smilacis glabrae. The rhizoma smilacis glabrae is preferably 12-18 parts by weight, and more preferably 16 parts by weight. The rhizoma smilacis glabrae has the effects of detoxifying, dehumidifying and benefiting joints, and is mainly used for treating stranguria, sinew and bone pain, beriberi, furuncle, carbuncle swelling, scrofula and the like. The source of the glabrous greenbrier rhizome is not particularly limited in the invention, and the glabrous greenbrier rhizome which is well known in the field can be adopted.
The traditional Chinese medicine composition provided by the invention comprises radix stemonae. The preferable radix stemonae is 6-9 parts by weight, and the more preferable radix stemonae is 8 parts by weight. The radix Stemonae has insecticidal effect, and can be used for treating head louse, body louse, enterobiasis, and pudendum pruritus. The source of the stemona root is not particularly limited in the invention, and the stemona root known in the field can be adopted.
The traditional Chinese medicine composition provided by the invention comprises cortex dictamni. The dittany bark is preferably 12-18 parts by weight, and more preferably 15 parts by weight. The cortex Dictamni Radicis has effects of clearing heat, eliminating dampness, dispelling pathogenic wind, relieving itching, and removing toxic substance, and can be used for treating rubella, eczema, scabies, jaundice and damp-heat arthralgia caused by wind-heat damp-toxin. The source of the cortex dictamni is not particularly limited in the invention, and the cortex dictamni which is well known in the field can be adopted.
The traditional Chinese medicine composition provided by the invention comprises radix sophorae flavescentis. The sophora flavescens is preferably 12-18 parts by weight, and more preferably 15 parts by weight. The radix sophorae flavescentis has the effects of clearing heat, promoting diuresis, resisting bacteria, diminishing inflammation, invigorating stomach and expelling parasites, and is commonly used for treating skin itch. The source of the sophora flavescens is not particularly limited in the present invention, and sophora flavescens known in the art can be used. Fructus Cnidii, Kochiae fructus, rhizoma Smilacis Glabrae, radix Stemonae, cortex Dictamni Radicis and radix Sophorae Flavescentis are ministerial drugs for assisting in removing toxic substance and killing parasite.
The traditional Chinese medicine composition provided by the invention comprises ilex purpurea Hassk. The preferred weight portion of the ilex purpurea is 12-18 parts, and the more preferred weight portion is 16 parts. Said ilex purpurea Hassk has effects of inhibiting Staphylococcus aureus, hemolytic streptococcus, dysentery (Freund's), typhoid fever, and Pseudomonas aeruginosa. The source of the ilex rotundifolia is not particularly limited in the invention, and ilex rotundifolia which is well known in the field can be adopted.
The traditional Chinese medicine composition provided by the invention comprises radix euphorbiae ebracteolatae. The part by weight of the radix euphorbiae lantu is preferably 12-16 parts, and more preferably 14 parts. Radix Euphorbiae Fischerianae has effects of eliminating phlegm, resolving food stagnation, and relieving pain, and can be used for treating scabies by external application. The source of the radix euphorbiae lantu is not particularly limited, and the radix euphorbiae lantu which is well known in the field can be adopted.
The traditional Chinese medicine composition provided by the invention comprises mint. The mint is preferably 6-9 parts by weight, and more preferably 8 parts by weight. Herba Menthae can be used for treating skin rubella, pruritus, measles without adequate eruption, carbuncle, cellulitis, scabies, tinea, and dermatitis. The source of the mint is not particularly limited in the present invention, and mint known in the art may be used. The ilex rotundifolia, the radix euphorbiae lantu and the mint are adjuvant drugs and play a role in dispelling wind and relieving itching.
In the present invention, the type of beriberi to be treated by the Chinese medicinal composition is not particularly limited, and may be applied to any type of beriberi known in the art, such as maceration type, blister type, and squamous keratosis type.
In the present invention, the type of the Chinese medicinal composition for treating tinea is not particularly limited, and may be applied to tinea corporis known in the art, such as tinea cruris, tinea capitis, tinea manuum, etc.
The invention provides a preparation method of the traditional Chinese medicine composition, which is different according to different prepared dosage forms, for example, the preparation method of the traditional Chinese medicine composition of a solid preparation comprises the following steps:
1) sequentially pulverizing cortex pseudolaricis, cortex Phellodendri, fructus Cnidii, Kochiae fructus, rhizoma Smilacis Glabrae, radix Stemonae, cortex Dictamni Radicis, radix Sophorae Flavescentis, radix Ilicis Pubescentis, radix Euphorbiae Fischerianae and herba Menthae, sieving with 20 mesh sieve, and collecting coarse powder of Chinese medicinal materials;
2) carrying out superfine grinding and sterilization on the traditional Chinese medicine coarse powder to obtain the traditional Chinese medicine composition.
In the present invention, the pulverizing process may be to pulverize each Chinese medicine separately and collect coarse powder to mix to obtain Chinese medicine coarse powder, or to pulverize the Chinese medicines together after mixing, and the pulverizing method of the present invention is not particularly limited, and may be a pulverizing method known in the art.
The method of the ultrafine pulverization is not particularly limited in the present invention, and a method of the ultrafine pulverization known in the art may be used. After the superfine grinding, sieving the mixture by a sieve with more than 300 meshes and collecting the undersize powder.
In the invention, the sterilization method can be a traditional Chinese medicine sterilization method well known in the art, for example, irradiation sterilization is carried out, the irradiation intensity is 13KGY, the irradiation time is 15-17 h, and more preferably 16 h; or selecting high-pressure steam for sterilization, wherein the specific parameters are 121 ℃, and the sterilization lasts 20-30 min.
In the invention, the sterilized traditional Chinese medicine superfine powder preferably also comprises subpackaging, granulating or tabletting. And (4) directly subpackaging the sterilized traditional Chinese medicine superfine powder, preferably 8 g/bag. The granulating method preferably comprises mixing water as binder with sterilized Chinese medicinal superfine powder to obtain soft material, sequentially granulating, drying, grading, and packaging to obtain granule.
In the tabletting method, 8-10 parts by mass of sterilized traditional Chinese medicine superfine powder, 3-4 parts by mass of citric acid and 3-4 parts by mass of sodium bicarbonate are preferably mixed, granulated, tabletted and subpackaged.
In the invention, 8g of Chinese herbal compound superfine powder is taken, added with 2000m L of hot water at 40-50 ℃ and used for foot bath for 30 minutes, 8g of Chinese herbal compound granules are taken, added with 2000m L of hot water at 40-50 ℃ and used for foot bath for 30 minutes, 1 granule of Chinese herbal compound effervescent tablet is taken, added with 2000m L of hot water at 40-50 ℃ and used for foot bath for 30 minutes, and the Chinese herbal compound effervescent tablet is used for foot bath once a day for 7-15 days continuously.
In the invention, the preparation method also comprises a preparation method of the traditional Chinese medicine composition spray;
heating and extracting the traditional Chinese medicine coarse powder by using an ethanol water solution with the volume concentration of 50-70%, wherein the heating and extracting temperature is 95-100 ℃; the volume ratio of the mass of the traditional Chinese medicine coarse powder to the ethanol water solution is 1g: 8-12 ml.
In the present invention, the volume concentration of the ethanol aqueous solution is preferably 60%, and the temperature of the heating extraction is preferably 100 ℃; the ratio of the mass of the traditional Chinese medicine coarse powder to the volume of the ethanol water solution is preferably 1g to 10 ml.
In the invention, the spray is sprayed on the affected part 1-2 times per day.
The following examples are provided to describe the Chinese medicinal composition for treating beriberi and tinea and the preparation method thereof in detail, but they should not be construed as limiting the scope of the present invention.
Example 1
Accurately weighing the following traditional Chinese medicine components: 10g of golden larch bark, 30g of golden cypress, 10g of common cnidium fruit, 30g of belvedere fruit, 10g of glabrous greenbrier rhizome, 10g of sessile stemona root, 10g of dittany bark, 20g of lightyellow sophora root, 10g of ilex rotunda, 20g of radix euphorbiae lantu and 5g of mint.
Mixing and crushing the weighed traditional Chinese medicines, sieving the mixture by a 20-mesh sieve, collecting oversize products, crushing the oversize products again until all the oversize products pass through the 20-mesh sieve, carrying out superfine crushing on the undersize products to 300 meshes, collecting traditional Chinese medicine superfine powder, carrying out irradiation sterilization, wherein the irradiation dose is 13KGY, and the irradiation time is 16 hours. The sterilized traditional Chinese medicine superfine powder is directly subpackaged into 8 g/bag of traditional Chinese medicine powder.
Example 2
Accurately weighing the following traditional Chinese medicine components by weight: 30g of golden larch bark, 20g of golden cypress, 20g of common cnidium fruit, 15g of belvedere fruit, 20g of glabrous greenbrier rhizome, 5g of sessile stemona root, 20g of dittany bark, 10g of lightyellow sophora root, 20g of ilex rotunda, 10g of radix euphorbiae lantu and 10g of mint.
Mixing the weighed traditional Chinese medicines, pulverizing, sieving with a 20-mesh sieve, collecting oversize products, pulverizing again until oversize products pass through the 20-mesh sieve, micronizing undersize products to 300-mesh, collecting traditional Chinese medicine superfine powder, and sterilizing with high pressure steam for 20min at 121 deg.C. Mixing 8g of sterilized traditional Chinese medicine superfine powder, 3.5 g of citric acid and 3.5 g of sodium bicarbonate, granulating, and tabletting to obtain the traditional Chinese medicine effervescent tablet.
Example 3
Accurately weighing the following traditional Chinese medicine components by weight: 20g of golden larch bark, 25g of golden cypress, 16g of common cnidium fruit, 23g of belvedere fruit, 16g of glabrous greenbrier rhizome, 8g of sessile stemona root, 15g of dittany bark, 15g of lightyellow sophora root, 16 parts of ilex rotunda, 14g of radix euphorbiae lantu and 8g of mint.
Mixing the weighed traditional Chinese medicines, crushing, sieving with a 20-mesh sieve, collecting oversize products, crushing again until the oversize products all pass through the 20-mesh sieve, collecting undersize products, extracting with 10 times volume of 60% ethanol aqueous solution at 100 ℃ for 2h, separating the extracting solution, and filling into a traditional Chinese medicine spray.
The prepared traditional Chinese medicine spray is sent to Guangzhou branch company of Tongdao standard technical service company Limited for detection, and the detection result is shown in figure 1. As can be seen from the results in FIG. 1, the Chinese medicinal spray has better antibacterial activity.
Example 4
120 patients with athlete's foot were selected as the study subjects. The treatment method is divided into a control group (miconazole nitrate cream) and an observation group (the invention group) according to the treatment method, and each group comprises 60 cases; in the control group, 37 males and 23 females are aged 19-68 years, the mean age (36.7 +/-3.2) years, the disease course is 20 d-10 years, the mean disease course (5.3 +/-1.6) years, the disease part is between 40 toes, and 25 instep or foot side edges, wherein the disease types are as follows: 30 cases were of the maceration type, 17 cases were of the blister type, and 13 cases were of the scale keratotic type. In the observation group, 35 males and 25 females are aged 20-70 years, the mean age (37.3 +/-3.4) years, the course of disease is 20 d-11 years, the mean course of disease (5.6 +/-1.5) years, the disease part is between the toes, 21 instep or foot side edges, wherein the disease types include 29 immersion intertrigo types, 16 blister types and 15 squamous keratosis types.
Inclusion criteria were: all subjects were diagnosed with tinea pedis and were informed consent and signed. Exclusion criteria: conscious disturbance, mental history and drug allergy. The clinical data of sex, age, disease course, disease location and disease type are basically consistent, and the difference has no statistical significance (P is more than 0.05).
Method of producing a composite material
The control group is treated by miconazole nitrate cream, and the specific method comprises the following steps: firstly, the affected part of a patient is cleared to be in a clean state, then miconazole nitrate cream is uniformly smeared on the affected part from inside to outside, the smearing range of the miconazole nitrate cream exceeds 1cm of the periphery of the affected part, the miconazole nitrate cream is smeared for 3 times/d, and the miconazole nitrate cream is smeared for 15d continuously.
The observation group adopts the traditional Chinese medicine compound superfine powder and a bag of hot water to soak for 30 minutes, wherein the shoes of the patients are sprayed with the traditional Chinese medicine compound extract for treatment, and the treatment method and the treatment time are consistent with those of the control group.
Observation items
The overall satisfaction rates (very satisfactory, satisfactory and unsatisfactory) were compared between the two groups of patients.
(2) The effect of the two groups after 7d and 15d treatment is compared (the treatment effect evaluation standard is that the clinical symptoms basically disappear and the microscopic examination of the fungus is negative, the effect is that the clinical symptoms are improved and the microscopic examination of the fungus is positive, and the effect is that the clinical symptoms are unchanged or worsened and the microscopic examination of the fungus is positive).
The patient satisfaction results 7 days after treatment are shown in table 1. The total satisfaction rate of the observation group is 95 percent and is obviously higher than 80 percent of that of the control group, and the difference has statistical significance (P is less than 0.05).
TABLE 1 statistical results of satisfaction after 7d administration of observation group and control group
Figure BDA0002501871050000071
The patient satisfaction results after 14 days of treatment are shown in table 2. Compared with the effect of the two groups after 15 days of treatment, the cure rate and the total effective rate of the observed group are respectively 88.3 percent and 96.7 percent which are respectively obviously higher than those of the control group, namely 63.3 percent and 81.7 percent, and the difference has statistical significance (P is less than 0.05).
TABLE 2 statistical results of satisfaction after 14d administration of observation group and control group
Figure BDA0002501871050000072
Figure BDA0002501871050000081
Example 5
120 patients with tinea corporis were selected as the study subjects. According to the treatment method, the treatment method is not divided into a control group (miconazole nitrate cream) and an observation group (the invention group), and each group comprises 60 cases; in the control group, the patients have tinea cruris 23, tinea capitis 16 and tinea manuum 21; in the observation group, 24 cases of tinea cruris, 17 cases of tinea capitis and 19 cases of tinea manuum are observed.
Inclusion criteria were: all subjects were diagnosed with tinea corporis and were informed consent and signed. Exclusion criteria: conscious disturbance, mental history and drug allergy. The clinical data of sex, age, disease course, disease location and disease type are basically consistent, and the difference has no statistical significance (P is more than 0.05).
Method of producing a composite material
The control group is treated by miconazole nitrate cream, and the specific method comprises the following steps: firstly, the affected part of a patient is cleared to be in a clean state, then miconazole nitrate cream is uniformly smeared on the affected part from inside to outside, the smearing range of the miconazole nitrate cream exceeds the periphery of the affected part by 1cm, the miconazole nitrate cream is smeared for 3 times/d, and the miconazole nitrate cream is smeared for 7d continuously.
The observation group is applied to the affected part with the extractive solution of Chinese medicinal composition, and the treatment method and treatment time are the same as those of the control group.
Observation items
The effect of the two groups after 7 days of treatment is compared (the treatment effect evaluation criteria are that the clinical symptoms basically disappear and the microscopic examination of the fungus is negative, the effect is that the clinical symptoms are improved and the microscopic examination of the fungus is positive, and the effect is that the clinical symptoms are unchanged or worsened and the microscopic examination of the fungus is positive).
The effective rate results after 7 days of treatment in the two groups are shown in table 3. The cure rate and the total effective rate of an observed group are respectively 88.3 percent and 98.3 percent, which are respectively obviously higher than 65 percent and 83.3 percent of a control group, and the difference has statistical significance (P is less than 0.05).
TABLE 3 statistical results of effective rate after 7 days of treatment
Figure BDA0002501871050000082
The evaluation standard of curative effect is as follows: mycology group of dermatological division of China Association of Chinese and Western medicine, mycosis subcontract of dermatological division of China Association of physicians, mycology group of dermatological division of China medical division of China (2017 revision) [ J ] diagnosis and treatment guidelines for tinea manus and tinea pedis (2017 revision) [ J ] J of China mycology, 2017,12(6): 321-324.
Comparative example 1
Accurately weighing the following traditional Chinese medicines by weight: 25g of phellodendron, 15g of common cnidium fruit, 25g of broom cypress fruit, 15g of glabrous greenbrier rhizome, 8g of sessile stemona root, 15g of densefruit pittany root-bark, 15g of lightyellow sophora root, 15g of ilex rotunda, 15g of radix euphorbiae lantu and 8g of mint. The medicinal powder is prepared according to the preparation method of the example 1, and the medicinal treatment is carried out on the population suffering from the dermatophytosis and the tinea corporis according to the methods of the example 4 and the example 5, and the treatment effect shows that the total effective rate of the formula on patients suffering from the dermatophytosis and the tinea corporis is respectively 70.6 percent and 74.3 percent, which is obviously lower than the total effective rate of the traditional Chinese medicine composition.
Comparative example 2
On the basis of the traditional Chinese medicine formula disclosed in the embodiment 3, golden cypress is replaced by coptis chinensis, iron holly is replaced by rheum officinale, radix sophorae flavescentis is replaced by euphorbia hirta, other combinations and the dosage are not changed, the treatment is carried out on the people suffering from the relevant beriberi and tinea corporis according to the methods of the embodiment 4 and the embodiment 5, the treatment results show that the total effective rates of the formula on patients suffering from the beriberi and the tinea corporis are 83.6% and 85.3% respectively, and the total effective rate is obviously lower than that of the combination.
Example 6
Case 1
Jiangzhi, male, 45 years old, Guangzhou city people, beriberi with full water bubbles on both feet, the course of disease is 4 years, and 6 months in 2018, the traditional Chinese medicine combination example 1 is used, 8g of traditional Chinese medicine compound ultrafine powder is taken, hot water of 2000m L at the temperature of 40-50 ℃ is added for soaking feet for 30 minutes, wherein shoes of patients are sprayed with the extracting solution of the traditional Chinese medicine compound combination example 3 for treatment, and the beriberi of the patients is cured in 15 days.
Case 2
Zhang Ying, women, 40 years old, Guangzhou city people, feet are full of cutin type beriberi, the course of disease is 5 years, and the invention is used in 2018, 9 months, the traditional Chinese medicine combination embodiment 2 is used, 1 granule of the traditional Chinese medicine compound effervescent tablet is taken, hot water of 2000m L with the temperature of 40-50 ℃ is added for soaking feet for 30 minutes, wherein the shoes of patients are sprayed with the extracting solution of the traditional Chinese medicine compound combination embodiment 3 for treatment, and the beriberi of the patients is cured in 15 days.
Case 3
Xie somebody, a man, 30 years old, Guangzhou city people have tinea corporis in groin, the course of disease is 1 year, and 6 months in 2019, the traditional Chinese medicine combination example 3 is used, the extracting solution of the traditional Chinese medicine combination example 3 is taken and smeared on the affected part for 3 times in 1 day, and the tinea corporis of a patient in 7 days is cured.
The results of the above examples show that the traditional Chinese medicine composition provided by the invention has a remarkable curative effect on various tinea and beriberi people.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.

Claims (10)

1. A traditional Chinese medicine composition for treating dermatophytosis and tinea is characterized by comprising the following components in parts by weight: 10-30 parts of golden larch bark, 20-30 parts of golden cypress, 10-20 parts of common cnidium fruit, 15-30 parts of belvedere fruit, 10-20 parts of glabrous greenbrier rhizome, 5-10 parts of sessile stemona root, 10-20 parts of dittany bark, 10-20 parts of lightyellow sophora root, 10-20 parts of ilex rotundus, 10-20 parts of radix euphorbiae lantu and 5-10 parts of mint.
2. The traditional Chinese medicine composition according to claim 1, which is characterized by comprising the following components in parts by weight: 20 parts of golden larch bark, 25 parts of golden cypress, 16 parts of common cnidium fruit, 23 parts of belvedere fruit, 16 parts of glabrous greenbrier rhizome, 8 parts of sessile stemona root, 15 parts of dittany bark, 15 parts of lightyellow sophora root, 16 parts of ilex rotundus, 14 parts of radix euphorbiae lantu and 8 parts of mint.
3. The composition of claim 1 or 2, wherein the beriberi comprises an erosion type, a blister type and a scaly keratotic type.
4. The composition of claim 1 or 2, wherein the tinea includes tinea cruris, tinea capitis, and tinea manuum.
5. The preparation method of the traditional Chinese medicine composition of any one of claims 1 to 4, which is characterized by comprising the following steps:
1) sequentially pulverizing cortex pseudolaricis, cortex Phellodendri, fructus Cnidii, Kochiae fructus, rhizoma Smilacis Glabrae, radix Stemonae, cortex Dictamni Radicis, radix Sophorae Flavescentis, radix Ilicis Pubescentis, radix Euphorbiae Fischerianae and herba Menthae, sieving with 20 mesh sieve, and collecting coarse powder of Chinese medicinal materials;
2) carrying out superfine grinding and sterilization on the traditional Chinese medicine coarse powder to obtain the traditional Chinese medicine composition.
6. The preparation method of claim 5, wherein the sterilized superfine powder of Chinese medicinal materials is further processed by packaging, granulating or tabletting.
7. The preparation method according to claim 6, wherein the granulation method comprises mixing the Chinese medicinal material micropowder after sterilization with water as a binder to prepare a soft mass, sequentially granulating, drying, grading and packaging.
8. The preparation method according to claim 6, wherein the tabletting method comprises the steps of mixing 8-10 parts by mass of sterilized traditional Chinese medicine superfine powder, 3-4 parts by mass of citric acid and 3-4 parts by mass of sodium bicarbonate, sequentially granulating, tabletting and subpackaging.
9. The preparation method of claim 5, further comprising preparing a spray of the Chinese medicinal composition;
heating and extracting the traditional Chinese medicine coarse powder by using an ethanol water solution with the volume concentration of 50-70%, wherein the heating and extracting temperature is 95-100 ℃; the volume ratio of the mass of the traditional Chinese medicine coarse powder to the ethanol water solution is 1g: 8-12 ml.
10. The preparation method according to claim 9, wherein the ethanol aqueous solution has a volume concentration of 60%, and the temperature of the heating extraction is 100 ℃; the ratio of the mass of the traditional Chinese medicine coarse powder to the volume of the ethanol water solution is 1g to 10 ml.
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