WO2022247922A1 - Application d'une composition médicinale tibétaine dans la préparation d'un médicament pour prévenir et/ou traiter la neuropathie périphérique diabétique - Google Patents

Application d'une composition médicinale tibétaine dans la préparation d'un médicament pour prévenir et/ou traiter la neuropathie périphérique diabétique Download PDF

Info

Publication number
WO2022247922A1
WO2022247922A1 PCT/CN2022/095456 CN2022095456W WO2022247922A1 WO 2022247922 A1 WO2022247922 A1 WO 2022247922A1 CN 2022095456 W CN2022095456 W CN 2022095456W WO 2022247922 A1 WO2022247922 A1 WO 2022247922A1
Authority
WO
WIPO (PCT)
Prior art keywords
tibetan
diabetic peripheral
medicine composition
parts
peripheral neuropathy
Prior art date
Application number
PCT/CN2022/095456
Other languages
English (en)
Chinese (zh)
Inventor
雷菊芳
刘凯列
陈维武
陈伦举
车向宜
李峰
刁习霞
Original Assignee
西藏奇正藏药股份有限公司
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 西藏奇正藏药股份有限公司 filed Critical 西藏奇正藏药股份有限公司
Publication of WO2022247922A1 publication Critical patent/WO2022247922A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/26—Iron; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/55—Glands not provided for in groups A61K35/22 - A61K35/545, e.g. thyroids, parathyroids or pineal glands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484—Glycyrrhiza (licorice)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/75—Rutaceae (Rue family)
    • A61K36/758—Zanthoxylum, e.g. pricklyash
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/84—Valerianaceae (Valerian family), e.g. valerian
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9068—Zingiber, e.g. garden ginger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Definitions

  • the invention relates to the technical field of Vietnamese medicine, in particular to the application of a Vietnamese medicine composition in the preparation of medicines for preventing and/or treating diabetic peripheral neuropathy.
  • Diabetes mellitus is a group of metabolic diseases characterized by chronic hyperglycemia caused by multiple etiologies. Long-term carbohydrate, fat, and protein metabolic disorders caused by relatively insufficient insulin secretion or decreased sensitivity of target cells to insulin can cause multiple systemic disorders. Damage to the eyes, kidneys, nerves, heart, blood vessels and other tissues and organs will lead to chronic progressive lesions, functional decline and failure. Among them, diabetic neuropathy is a complication caused by long-term chronic high blood sugar damage to the nervous system, and its clinical incidence rate can reach 47%-91%. Diabetic neuropathy mainly includes diabetic central neuropathy and peripheral neuropathy, especially the latter.
  • ischemic cerebrovascular disease such as cerebral arteriosclerosis, cerebral infarction, occlusive vascular disease, cerebral ischemia, stroke, partial dryness, etc.
  • cognitive dysfunction epilepsy, chronic encephalopathy, etc.
  • Symptoms associated with diabetic peripheral neuropathy are mainly sensory disturbances, including symmetrical pain and paresthesia in the extremities, more common in the lower extremities than in the upper extremities, intermittent or continuous attacks, burning sensation or electric shock-like pain, aggravated at rest or at night.
  • the medicines used by western medicine to treat diabetic peripheral neuropathy mainly include the following categories: (1) opioid analgesics, such as morphine; (2) antidepressants, such as naproxen; (3) local anesthetics , such as lidocaine; (4) neurotrophic drugs, methylcobalamin, etc.
  • opioid analgesics such as morphine
  • antidepressants such as naproxen
  • local anesthetics such as lidocaine
  • neurotrophic drugs methylcobalamin
  • traditional drugs still have many defects, such as opioid analgesics, antidepressants and local anesthetics have high side effects and adverse reactions and are expensive, and methylcobalamin has limited or insufficient efficacy and slow onset of action. Therefore, there is an urgent need for a drug that can effectively prevent and/or treat diabetic peripheral neuropathy.
  • Baimai ointment is composed of turmeric, nutmeg, nard pine, actinolite, licorice, artificial musk, dried ginger, Vietnamese fennel, Vietnamese calamus, pepper, and alkali flower. It has the effect of relaxing tendons and activating collaterals. Clinically, it is widely used for white pulse disease, paralysis, hemiplegia, tendon stiffness, meridian and tendon rupture caused by trauma, hand and foot spasm, claudication, etc. At present, there is no research report on the prevention and treatment of diabetic peripheral neuropathy with Baimai ointment or its related Vietnamese medicine composition.
  • the object of the present invention is to provide a kind of application of Vietnamese medicine composition in the medicine of preparation prevention and/or treatment diabetic peripheral neuropathy.
  • the Vietnamese medicine composition includes the following raw materials: turmeric, nutmeg, nard pine, actinolite, licorice, artificial musk, dried ginger, Vietnamese fennel, Vietnamese calamus, peppercorns and alkali flowers.
  • the diabetic peripheral neuropathy is caused by diabetic peripheral nerve damage.
  • the Vietnamese medicine composition includes the following raw materials: 30-40 parts of turmeric, 10-15 parts of nutmeg, 15-25 parts of nard pine, 10-15 parts of actinolite, 15-20 parts of licorice, 0.1-0.2 parts of artificial musk, 20-30 parts of dried ginger, 25-35 parts of Vietnamese fennel, 15-20 parts of Vietnamese calamus, 10-15 parts of pepper and 15-20 parts of alkali flower.
  • the Vietnamese medicine composition is a composition obtained by pulverizing and mixing various raw materials, or a combination of extracts extracted by conventional extraction methods after mixing each raw drug, or a combination of extracts obtained by extracting separately things.
  • the medicament is a traditional oral dosage form or external dosage form in the field after processing a Vietnamese medicine composition through a conventional preparation process.
  • the oral dosage form is selected from granules, pills, capsules, tablets or oral liquids
  • the external dosage form is selected from ointments, plasters, aerosols, sprays, wet compresses, washes, etc. medicament or gel
  • the conventional preparation process includes medicinal material crushing, decoction, percolation, leaching, ultrasonic or steam distillation.
  • the medicine also includes a pharmaceutically acceptable carrier;
  • the pharmaceutically acceptable carrier is selected from pharmaceutically acceptable solvents, solubilizers, cosolvents, emulsifiers, coloring agents, binders , disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, glidants, flavoring agents, preservatives, suspending agents, coating materials, fragrances, anti-adhesives, Integrator, penetration enhancer, pH regulator, buffer, plasticizer, surfactant, thickener, inclusion agent, humectant, absorbent, diluent, flocculant, deflocculant, filter aid, At least one of a release retardant, a polymer framework material and a film-forming material.
  • the pharmaceutical preparation is an ointment, and the ointment also includes an ointment base.
  • the mass ratio of the Vietnamese medicine composition to the ointment base is 0.5:9.5-5:5.
  • the ointment base comprises polysorbate 80, liquid paraffin, glycerin, methylparaben and water, preferably, the mass ratio of polysorbate 80, liquid paraffin, glycerin, methylparaben and water For 1-10: 20-60: 20-60: 0.5-2: 200-400.
  • the preparation method of the ointment comprises the following steps:
  • turmeric Take turmeric, nutmeg, nard pine, actinolite, licorice, dried ginger, Vietnamese fennel, Vietnamese calamus, prickly ash and alkali flower, grind them, mix with ointment base, add artificial musk, and mix to prepare.
  • the present invention also provides an application of any Vietnamese medicine composition or pharmaceutical preparation described in the present invention in the preparation of medicines, and the medicines have the following purposes:
  • a method for preventing and/or treating diabetic peripheral neuropathy comprising administering the Vietnamese medicine composition as described above to a subject in need.
  • the administration of the Vietnamese medicine composition lasts for 2-8 weeks, preferably 4-8 weeks.
  • the dosage of the Vietnamese medicine composition is 0.1-0.9 g crude drug/kg body weight, preferably 0.1, 0.3 or 0.9 g crude drug/kg body weight.
  • the Vietnamese medicine composition of the present invention can improve the sensitivity of nerve endings in diabetic peripheral nerve injury model mice, and relieve the symptoms of hypoalgesia and limb numbness caused by diabetic peripheral nerve injury.
  • the Vietnamese medicine composition of the present invention prevents and/or treats diabetic peripheral nerve injury, improves the motor nerve conduction velocity of diabetic peripheral nerve injury model mice, illustrates that the Vietnamese medicine composition of the present invention can prevent and/or treat Diabetic peripheral neuropathy, a potential drug for diabetic peripheral neuropathy.
  • Embodiment 1 ointment
  • This embodiment provides a Vietnamese medicine composition
  • the raw material formula is as follows: turmeric 36.3g, nutmeg 12.1g, nard pine 19.4g, actinolite 12.1g, licorice 17.0g, artificial musk 0.17g, dried ginger 24.2g, Vietnamese fennel 31.5g, Vietnamese calamus 17.0g, pepper 12.1g, alkali flower 18.2g.
  • the ointment of the above-mentioned Vietnamese medicine composition includes: turmeric 36.3g, nutmeg 12.1g, nard pine 19.4g, actinolite 12.1g, licorice 17.0g, artificial musk 0.17g, dried ginger 24.2g g, 31.5g of Vietnamese fennel, 17.0g of Vietnamese calamus, 12.1g of Zanthoxylum bungeanum, 18.2g of alkali flower, 80g of liquid paraffin, 80g of glycerin, 10g of polysorbate 80, 10g of methylparaben, and the balance is water.
  • Preparation method Weigh turmeric, nutmeg, nard pine, actinolite, licorice, dried ginger, Vietnamese fennel, Vietnamese calamus, Zanthoxylum bungeanum and alkali flower according to the above formula, grind them into coarse powder, mix, add liquid paraffin, glycerin, poly Sorbitan 80, Methylparaben and Water. Stir at 80°C to make an ointment, cool down to 38°C, add artificial musk, and stir well to obtain 1000 g of ointment, leave it at room temperature for 4.5 hours, pack it separately, and obtain.
  • Embodiment 2 Wet compress
  • This embodiment provides a Vietnamese medicine composition
  • the raw material formula is as follows: turmeric 30g, nutmeg 15g, nard pine 15g, actinolite 15g, licorice 15g, artificial musk 0.2g, dried ginger 20g, Vietnamese fennel 35g, Vietnamese calamus 15g, Zanthoxylum bungeanum 15g, Suihua 20g.
  • the wet compress of the above-mentioned Vietnamese medicine composition, raw materials include: 36.3g of turmeric, 12.1g of nutmeg, 19.4g of nard pine, 12.1g of actinolite, 17.0g of licorice, 0.17g of artificial musk, 24.2g of dried ginger, 31.5g of Vietnamese fennel g, Vietnamese calamus 17.0g, Zanthoxylum bungeanum 12.1g, alkali flower 18.2g.
  • Preparation method Take turmeric, nutmeg, nard pine, actinolite, licorice, artificial musk, dried ginger, Vietnamese fennel, Vietnamese calamus, Zanthoxylum bungeanum, and alkali flower according to the above formula, crush them into coarse powder, and mix; add an appropriate amount of 60vt % ethanol impregnated, then percolated with 60vt% ethanol as a solvent, collected percolated liquid to obtain percolated liquid of Vietnamese medicine composition, made carrier of non-woven fabric and immersed in fine filtrate, sealed and packaged in pieces to obtain wet compress .
  • This embodiment provides a Vietnamese medicine composition
  • the raw material formula is as follows: turmeric 40g, nutmeg 10g, nard pine 25g, actinolite 10g, licorice 20g, artificial musk 0.1g, dried ginger 30g, Vietnamese fennel 25g, Vietnamese calamus 20g, pepper 10g, alkali flower 15g.
  • the tablet of above-mentioned Vietnamese medicine composition, raw material formula comprises: turmeric 40g, nutmeg 10g, nard pine 25g, actinolite 10g, licorice 20g, artificial musk 0.1g, dried ginger 30g, Vietnamese fennel 25g, Vietnamese calamus 20g, Chinese prickly ash 10g, 15g of alkali flower, 90g of starch, 5g of magnesium stearate.
  • Preparation method Take turmeric, nutmeg, nard pine, actinolite, licorice, dried ginger, Vietnamese fennel, Vietnamese calamus, Chinese prickly ash, artificial musk and alkali flower according to the above formula, grind them into coarse powder, mix, add starch and mix, Make granules, add magnesium stearate and compress into tablets.
  • Embodiment 4 ointment
  • This embodiment provides a Vietnamese medicine composition
  • the raw material formula is as follows: turmeric 40g, nutmeg 10.5g, nard pine 25g, actinolite 10.2g, licorice 20g, artificial musk 0.1g, dried ginger 30g, Vietnamese fennel 25.5g , Vietnamese calamus 20g, pepper 10.3g, alkali flower 15.5g.
  • the ointment of the above-mentioned Vietnamese medicine composition includes: turmeric 40g, nutmeg 10g, nard pine 25g, actinolite 10g, licorice 20g, artificial musk 0.1g, dried ginger 30g, Vietnamese fennel 25g, Vietnamese calamus 20g, pepper 10g, alkali flower 15g, liquid paraffin 320g, glycerin 320g, 80g polysorbate 80, methylparaben 8g, and the balance is water.
  • Preparation method Weigh turmeric, nutmeg, nard pine, actinolite, licorice, dried ginger, Vietnamese fennel, Vietnamese calamus, Zanthoxylum bungeanum and alkali flower according to the above formula, grind them into coarse powder, mix, add liquid paraffin, glycerin, poly Sorbitan 80, Methylparaben and Water. Stir at 80°C to make an ointment, cool down to 38°C, add artificial musk, and stir well to obtain 1000 g of ointment, leave it at room temperature for 4 hours, pack it separately, and obtain.
  • Embodiment 5 ointment
  • This embodiment provides a Vietnamese medicine composition
  • the raw material formula is as follows: turmeric 36.3g, nutmeg 12.1g, nard pine 19.4g, actinolite 12.1g, licorice 17.0g, artificial musk 0.17g, dried ginger 24.2g, Vietnamese fennel 31.5g, Vietnamese calamus 17.0g, pepper 12.1g, alkali flower 18.2g.
  • the ointment of the above-mentioned Vietnamese medicine composition includes: turmeric 36.3g, nutmeg 12.1g, nard pine 19.4g, actinolite 12.1g, licorice 17.0g, artificial musk 0.17g, dried ginger 24.2g g, 31.5g of Vietnamese fennel, 17.0g of Vietnamese calamus, 12.1g of Zanthoxylum bungeanum, 18.2g of alkali flower, 20g of liquid paraffin, 20g of glycerin, 10g of polysorbate 10, 2g of methylparaben, and the balance is water.
  • Preparation method Weigh turmeric, nutmeg, nard pine, actinolite, licorice, dried ginger, Vietnamese fennel, Vietnamese calamus, Zanthoxylum bungeanum and alkali flower according to the above formula, grind them into coarse powder, mix, add liquid paraffin, glycerin, poly Sorbitan 80, Methylparaben and Water. Stir at 80°C to make an ointment, cool down to 38°C, add artificial musk, and stir well to obtain 1000 g of ointment, leave it at room temperature for 5 hours, pack it separately, and obtain.
  • This embodiment provides a Vietnamese medicine composition
  • the raw material formula is as follows: turmeric 36.3g, nutmeg 12.1g, nard pine 19.4g, actinolite 12.1g, licorice 17.0g, artificial musk 0.17g, dried ginger 24.2g, Vietnamese fennel 31.5g, Vietnamese calamus 17.0g, pepper 12.1g, alkali flower 18.2g.
  • the gel of the above-mentioned Vietnamese medicine composition includes: turmeric 36.3g, nutmeg 12.1g, nard pine 19.4g, actinolite 12.1g, licorice 17.0g, artificial musk 0.17g, dried ginger 24.2g, Vietnamese fennel 31.5g, Vietnamese calamus 17.0g, Zanthoxylum bungeanum 12.1g, Suihua 18.2g, Carbomer 940 10.0g, Glycerin 30g, Methylparaben 2.0g, Polysorbate 80 3.0g, the balance is water .
  • Preparation method Take turmeric, nutmeg, nard pine, actinolite, licorice, dried ginger, Vietnamese fennel, Vietnamese calamus, Zanthoxylum bungeanum and alkali flower according to the above formula, grind them into coarse powder, and mix them to obtain medicinal material powder. Add 200g of water to Carbomer 940 and swell overnight at 70°C, add glycerin, methylparaben, polysorbate 80 and medicinal powder and stir to make a gel, add artificial musk and the rest of water, and stir well to make a gel 1000g, divided into packages, ready to use.
  • This embodiment provides a Vietnamese medicine composition
  • the raw material formula is as follows: turmeric 36.3g, nutmeg 12.1g, nard pine 19.4g, actinolite 12.1g, licorice 17.0g, artificial musk 0.17g, dried ginger 24.2g, Vietnamese fennel 31.5g, Vietnamese calamus 17.0g, pepper 12.1g, alkali flower 18.2g.
  • the plaster of the above-mentioned Vietnamese medicine composition includes: 36.3g of turmeric, 12.1g of nutmeg, 19.4g of Gansong, 12.1g of actinolite, 17.0g of licorice, 0.17g of artificial musk, 24.2g of dried ginger, 31.5g of Vietnamese fennel, Vietnamese calamus 17.0g, pepper 12.1g, alkali flower 18.2g, rubber 30g, rosin 50g, zinc oxide 40g.
  • Preparation method Weigh turmeric, nutmeg, nard pine, actinolite, licorice, dried ginger, Vietnamese fennel, Vietnamese calamus, pepper and alkali flower according to the above formula, add water to decoct twice, add 8 times the amount of water for the first time Decoct for 2 hours, add 6 times the amount of water for the second time and decoct for 1 hour, combine the filtrates, and concentrate to a clear paste (45 ⁇ 2°C) with a density of 1.15-1.25g/cm 3 . Rubber, rosin, zinc oxide and ethanol are impregnated, stirred, and the ethanol is recovered to make a glue. The clear paste is added to the glue, coated on a non-woven fabric backing, and packaged separately to obtain a plaster, a total of 1000 stickers.
  • This embodiment provides a Vietnamese medicine composition
  • the raw material formula is as follows: turmeric 36.3g, nutmeg 12.1g, nard pine 19.4g, actinolite 12.1g, licorice 17.0g, artificial musk 0.17g, dried ginger 24.2g, Vietnamese fennel 31.5g, Vietnamese calamus 17.0g, pepper 12.1g, alkali flower 18.2g.
  • the aerosol of the above-mentioned Vietnamese medicine composition includes: turmeric 36.3g, nutmeg 12.1g, nard pine 19.4g, actinolite 12.1g, licorice 17.0g, artificial musk 0.17g, dried ginger 24.2g, Vietnamese fennel 31.5g , Vietnamese calamus 17.0g, pepper 12.1g, alkali flower 18.2g, methylparaben 2.0g, polysorbate 80 20.0g, ethanol 100g.
  • Preparation method weigh turmeric, nutmeg, nard pine, actinolite, licorice, dried ginger, Vietnamese fennel, Vietnamese calamus, Zanthoxylum bungeanum and alkali flower according to the above formula, add 10 times the amount of ethanol for percolation, and recover ethanol from the percolation liquid. Concentrate to a clear paste (30 ⁇ 2°C) with a density of 1.05-1.10g/cm 3 . Clear cream, methylparaben, polysorbate 80, and ethanol were mixed, filtered, added water to 1000ml, and filtered again. Dispensed into bottles with spray valves, ready to serve.
  • mice Male (Lepr) ko/ko genotype mice are model mice, SPF grade, 8 weeks old, weighing 35-55 g, 80. Male (Lepr) wt/wt genotype mice were used as control mice, SPF grade, 8 weeks old, 10 mice weighing 20-30 g. All experimental animals were provided by Jiangsu Jicui Yaokang Biotechnology Co., Ltd.
  • Example 1 of the present invention Using the ointment prepared in Example 1 of the present invention, another ointment base was taken as a placebo and given to the experimental animals according to the dosage shown in Table 1.
  • the preparation of the ointment base used in the placebo group is to take liquid paraffin 80g, glycerol 80g, 10g polysorbate 80, methyl paraben 10g and water 628g, stir at 80 °C to make ointment, place at room temperature for 4.5 hours, namely have to.
  • Placebo group (model control group) 0g crude drug amount/kg animal body weight 1.5 ⁇ 1.5
  • mice Male (Lepr) ko/ko genotype db/db mice were used to naturally form a diabetic peripheral neuropathy model, and the effects of different doses of the test drug on peripheral neuropathy were observed.
  • Male (Lepr) wt/wt genotype mice were used as normal control group. Animals were free to ingest food and water. After hyperglycemia occurred in (Lepr)ko/ko genotype mice, MCV, SCV and blood glucose were measured once a week. The blood glucose was randomly and balancedly divided into 5 groups, which were model control group, test drug group (low dose group, middle dose group and high dose group) and positive drug group, with 10 rats in each group. The mouse thighs were shaved.
  • the model control group and the test drug group applied the placebo and the test drug to the sciatic nerve of the mouse leg, once a day. week.
  • the administration amount of low dose group is 0.1g crude drug amount/kg animal body weight
  • the administration amount of middle dose group is 0.3g crude drug amount/kg animal body weight
  • the administration amount of high dose group is 0.9g Crude drug amount/kg animal body weight
  • the model control group was given the same volume of ointment base as the high-dose group.
  • the positive drug group was gavaged once a day with methylcobalamin solution (the solvent was distilled water, the mass concentration was 0.015 mg/ml), the gavage volume: 20 mL/kg animal weight, and the administration period was 8 weeks.
  • mice in each group were placed on the suspended wire grid inside the transparent glass observation box to move freely. After the combing and exploring activities basically disappeared, the standardized fiber silk was used to stimulate the soles of the feet vertically for 5 seconds. After the stimulation, the experimental mice were recorded. Stimulation intensity at which rapid paw withdrawal or paw licking response occurs. Measure 3 times, each interval (3 ⁇ 5) min, get 3 average values as the pain threshold of the mice, and measure once every two weeks when grouping and after administration.
  • the mouse was anesthetized, it was fixed on the mouse board, the left hind leg was straightened and fixed, the stimulating electrode was inserted at the left sciatic notch, the recording electrode was placed at the ankle joint, and the reference electrode was placed between the stimulating electrode and the recording electrode. All electrodes in the test are needle electrodes.
  • the pain threshold of the model control group was always significantly higher than that of the normal control group (P ⁇ 0.01-0.001).
  • the experimental drug 0.1, 0.3, 0.9g crude drug/kg can reduce the pain threshold of model mice to varying degrees (P ⁇ 0.05-0.001); administration (2-8 ) weeks, the positive drug methylcobalamin 0.3mg/kg can reduce the pain threshold of model mice to varying degrees (P ⁇ 0.05 ⁇ 0.001), the results are shown in Table 2.
  • the test drug 0.9 g crude drug/kg can reduce the pain threshold of the model mice to varying degrees (P ⁇ 0.05).
  • the positive drug methylcobalamin 0.3mg/kg can reduce the pain threshold of the model mice to varying degrees (P ⁇ 0.05). The results are shown in Table 3.
  • n number of samples.
  • the experimental drug can reduce the pain threshold of the model mice, and the drug effect has no significant difference from methylcobalamin, indicating that the experimental drug can improve the sensitivity of the nerve endings of the diabetic model mice with neuropathy. It can be known that it can relieve the symptoms of limb numbness in patients with diabetic peripheral neuropathy.
  • the test drug 0.9g crude drug/kg can improve the motor nerve conduction velocity of the model mice to varying degrees (P ⁇ 0.05).
  • the positive drug methylcobalamin 0.3mg/kg can improve the motor nerve conduction velocity of the model mice to varying degrees (P ⁇ 0.05). The results are shown in Table 5.
  • n Number of samples.
  • the test drug 0.1, 0.3, 0.9g crude drug/kg continuous administration (2-8) weeks can improve the pain threshold and sciatic nerve motor nerve conduction velocity of the model mice to varying degrees , indicating that the test drug can alleviate the sensory impairment of diabetic model mice by increasing the sciatic motor nerve conduction velocity of diabetic mice.

Landscapes

  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Developmental Biology & Embryology (AREA)
  • Obesity (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Hematology (AREA)
  • Immunology (AREA)
  • Virology (AREA)
  • Zoology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)

Abstract

Application d'une composition médicinale tibétaine dans la préparation d'un médicament pour prévenir et/ou traiter la neuropathie périphérique diabétique. La composition médicinale tibétaine comprend les matières brutes suivantes : le curcuma, la noix de muscade, le nard, l'actinolite, la réglisse, le musc synthétique, le gingembre séché, le fenouil tibétain, le calamus tibétain, le clavalier frêne chinois et le trona. La composition médicinale tibétaine peut améliorer la sensibilité des terminaisons nerveuses chez des souris modèles présentant une lésion du nerf périphérique diabétique, atténuer les symptômes de l'hypoalgésie et de l'engourdissement des membres dus à une lésion du nerf périphérique diabétique, et accroître la vitesse de conduction nerveuse motrice de souris modèles présentant une lésion du nerf périphérique diabétique, et constitue un médicament potentiel pour la neuropathie périphérique diabétique.
PCT/CN2022/095456 2021-05-27 2022-05-27 Application d'une composition médicinale tibétaine dans la préparation d'un médicament pour prévenir et/ou traiter la neuropathie périphérique diabétique WO2022247922A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202110587145.6A CN113181331A (zh) 2021-05-27 2021-05-27 一种藏药组合物在制备预防和/或治疗糖尿病性周围神经病变的药物中的应用
CN202110587145.6 2021-05-27

Publications (1)

Publication Number Publication Date
WO2022247922A1 true WO2022247922A1 (fr) 2022-12-01

Family

ID=76985508

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2022/095456 WO2022247922A1 (fr) 2021-05-27 2022-05-27 Application d'une composition médicinale tibétaine dans la préparation d'un médicament pour prévenir et/ou traiter la neuropathie périphérique diabétique

Country Status (2)

Country Link
CN (1) CN113181331A (fr)
WO (1) WO2022247922A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113876907A (zh) * 2021-10-28 2022-01-04 西藏神猴药业有限责任公司 四味姜黄汤散在防治糖尿病周围神经病变中的应用

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101698094A (zh) * 2009-11-05 2010-04-28 甘肃奇正藏药有限公司 一种治疗白脉病的露剂及其制备方法
CN101700385A (zh) * 2009-11-05 2010-05-05 甘肃奇正藏药有限公司 一种治疗白脉病的药物组合物酒剂或酊剂及其制备方法
CN101703753A (zh) * 2009-11-05 2010-05-12 甘肃奇正藏药有限公司 一种治疗白脉病的药物组合物散剂或颗粒剂及其制备方法
CN106310131A (zh) * 2016-09-30 2017-01-11 四川易创生物科技有限公司 一种用于治疗白脉病的丸剂药物及其制备方法

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100389814C (zh) * 2006-01-25 2008-05-28 甘肃奇正藏药有限公司 一种治疗白脉病的软膏剂及制备方法
CN111298075B (zh) * 2018-12-12 2021-12-31 甘肃奇正藏药有限公司 一种中药组合物及其制备方法与应用

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101698094A (zh) * 2009-11-05 2010-04-28 甘肃奇正藏药有限公司 一种治疗白脉病的露剂及其制备方法
CN101700385A (zh) * 2009-11-05 2010-05-05 甘肃奇正藏药有限公司 一种治疗白脉病的药物组合物酒剂或酊剂及其制备方法
CN101703753A (zh) * 2009-11-05 2010-05-12 甘肃奇正藏药有限公司 一种治疗白脉病的药物组合物散剂或颗粒剂及其制备方法
CN106310131A (zh) * 2016-09-30 2017-01-11 四川易创生物科技有限公司 一种用于治疗白脉病的丸剂药物及其制备方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
CHINA MEDICAL ASSOCIATION OF MINORITIES: "Baimai Ointment", GUIDELINES FOR CLINICAL MEDICATION OF ETHNIC MINORITY MEDICINES, 31 January 2019 (2019-01-31), CN, pages 97 - 101, XP009542645, ISBN: 978-7-5132-5357-4 *

Also Published As

Publication number Publication date
CN113181331A (zh) 2021-07-30

Similar Documents

Publication Publication Date Title
US20170290778A1 (en) Compositions for topical application of compounds
KR20070054222A (ko) 진통 작용이 있는 약제 조성물
KR20100020461A (ko) 중약 조성물의 새로운 용도
CN102068474A (zh) 刺山柑果凝胶膏剂及其生产方法和抗风湿药物的应用
JP5928732B2 (ja) 褐色脂肪細胞活発化剤
WO2022247922A1 (fr) Application d'une composition médicinale tibétaine dans la préparation d'un médicament pour prévenir et/ou traiter la neuropathie périphérique diabétique
CN101732668B (zh) 一种治疗泌尿系统感染的中药组合物的制备方法
CN101284050B (zh) 延胡索水溶性部位药物及制备方法和用途
WO2017146230A1 (fr) Procédé de test
CN102488725A (zh) 治疗心脑血管疾病的舒脑欣乳剂及制备方法
CN103550671B (zh) 珍龙醒脑药物组合物在制备治疗糖尿病周围神经病变药物中的应用
KR101598600B1 (ko) 천수근 및 가시오가피 복합추출물을 유효성분으로 포함하는 통증의 완화, 예방 또는 치료용 조성물
RU2546522C2 (ru) Фармацевтическая композиция для лечения зависимости от наркотиков
CN111298075B (zh) 一种中药组合物及其制备方法与应用
CN102048715B (zh) 反式茴香脑用于制备药物或保健品的应用
CN102526387B (zh) 一种治疗早期糖尿病足的药物组合物及制备方法
JP5265347B2 (ja) 急性および慢性気管支炎を治療するための医薬を調合する際の魔芋（こんにゃく芋）およびその抽出物の利用
CN104258034A (zh) 一种增强免疫力的中药组合物
CN101711857B (zh) 一种治疗白脉病的涂膜剂及其制备方法
CN108403980A (zh) 一种降血糖植物提取物有效部位及其制备方法和应用
JPS61194031A (ja) 制癌作用増強剤
CN113967220B (zh) 具有急性心梗疗效的药物活性组合物
CN103768307A (zh) 一种治疗中风后肢体麻木的中药及其制备方法
CN105311065A (zh) 一种通经草提取物在制备治疗心脑血管疾病药物中的应用
CN109172600B (zh) 一种药物组合物及其用途

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22810646

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 22810646

Country of ref document: EP

Kind code of ref document: A1