WO2019080115A1 - 一种用于治疗皮肤溃疡的长效缓释中药冷敷贴 - Google Patents

一种用于治疗皮肤溃疡的长效缓释中药冷敷贴

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Publication number
WO2019080115A1
WO2019080115A1 PCT/CN2017/108110 CN2017108110W WO2019080115A1 WO 2019080115 A1 WO2019080115 A1 WO 2019080115A1 CN 2017108110 W CN2017108110 W CN 2017108110W WO 2019080115 A1 WO2019080115 A1 WO 2019080115A1
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WO
WIPO (PCT)
Prior art keywords
chinese medicine
traditional chinese
parts
long
cold compress
Prior art date
Application number
PCT/CN2017/108110
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English (en)
French (fr)
Inventor
吴克
Original Assignee
江苏奇力康皮肤药业有限公司
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Publication date
Application filed by 江苏奇力康皮肤药业有限公司 filed Critical 江苏奇力康皮肤药业有限公司
Priority to PCT/CN2017/108110 priority Critical patent/WO2019080115A1/zh
Priority to CN201780001787.5A priority patent/CN107995867A/zh
Publication of WO2019080115A1 publication Critical patent/WO2019080115A1/zh

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    • 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)
    • A61K36/752—Citrus, e.g. lime, orange or lemon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02—Compresses or poultices for effecting heating or cooling
    • 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
    • A61K35/56—Materials from animals other than mammals
    • A61K35/618—Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
    • 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
    • A61K36/11—Pteridophyta or Filicophyta (ferns)
    • A61K36/12—Filicopsida or Pteridopsida
    • 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)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • 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
    • A61K36/483—Gleditsia (locust)
    • 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)
    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/76—Salicaceae (Willow family), e.g. poplar
    • 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)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A61K36/8998—Hordeum (barley)
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02—Compresses or poultices for effecting heating or cooling
    • A61F2007/0225—Compresses or poultices for effecting heating or cooling connected to the body or a part thereof
    • A61F2007/0226—Compresses or poultices for effecting heating or cooling connected to the body or a part thereof adhesive, self-sticking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation 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
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH

Definitions

  • the invention belongs to the field of traditional Chinese medicine, and relates to a traditional Chinese medicine preparation and a preparation method thereof, in particular to a long-acting sustained-release traditional Chinese medicine cold application for treating skin ulcer.
  • Skin ulcers are chronic infectious diseases caused by various causes. They are skin or mucosal defects caused by tissue ischemia and necrosis. Due to poor local nutritional status, poor blood circulation and low resistance, it is easy to repeat on this basis. A vicious circle of infection. The treatment and healing process of skin ulcer wounds is complicated and takes a long time. After the wound is healed, there are sequelae such as scar contracture and dysfunction.
  • the object of the present invention is to provide a long-acting sustained-release traditional Chinese medicine cold compress for treating skin ulcers, which can be adhered to a skin ulcer wound, and the active ingredient of the traditional Chinese medicine embedded in the gel matrix can be It is continuously and stably released into the ulcer lesion area, and the effect is long-lasting, and it does not cause secondary damage to the wound due to wound adhesion during dressing change, and keeps the wound clean and hygienic.
  • the moist environment in which the matrix maintains the ulcer surface further promotes the healing of the ulcer.
  • the traditional Chinese medicine cold application further comprises 5-15 parts by weight of a gel matrix to form a hydrogel adjuvant for treating skin ulcers, which not only maintains the moist environment required for wound healing, but also prevents dressing changes due to The secondary damage caused by the patch sticking to the wound.
  • the traditional Chinese medicine cold compress further comprises 1-5 parts by weight of a transdermal enhancer, which promotes penetration of the active ingredient of the traditional Chinese medicine into the skin and fully exerts the drug effect.
  • a transdermal enhancer which promotes penetration of the active ingredient of the traditional Chinese medicine into the skin and fully exerts the drug effect.
  • the gel matrix comprises 30-60 wt% of tragacanth, 15-40 wt% of konjac gum, 12-25 wt% of locust bean gum and 3-8 wt% of ⁇ -cyclodextrin, four
  • the substances cross-link to each other to form a stable three-dimensional network, and the prepared gel excipient has excellent gas permeability and moisture permeability, and has excellent tensile strength and mechanical strength.
  • the transdermal enhancer comprises 40-60 wt% of wintergreen oil, 30-50 wt% of eucalyptus oil, 3-7 wt% of glycerol and 2-5 wt% of myristyl alcohol, four substances.
  • synergistic action can effectively penetrate the scar keratinous tissue and promote the active ingredients of traditional Chinese medicine patches.
  • the raw material component is ground into a powder, then impregnated, extracted and passed through ethanol. After filtration, a cold application of the traditional Chinese medicine is prepared.
  • the powder has a particle diameter of 100 to 500 ⁇ m, and the extraction is dynamic extraction.
  • the particle diameter of the raw material powder does not need to be too fine, and the particle diameter is 100 to 500 ⁇ m, which is effective.
  • the extraction of the components not only reduces the cost of pulverization, but also avoids excessive dynamic extraction pressure due to excessive powder.
  • the powder is dynamically extracted by using 90% by weight of ethanol, and the dissolution rate of the active ingredient is fast, and the dissolution efficiency is high.
  • the 90 wt% ethanol is 5-8 times the volume of the powder to ensure sufficient extraction of the active ingredient of the traditional Chinese medicine.
  • the invention has the beneficial effects that the long-acting sustained-release traditional Chinese medicine cold application for treating skin ulcer provided by the invention can significantly shorten the healing time of skin ulcer wounds, has high healing rate, and can effectively prevent scar formation of ulcer wounds.
  • a long-acting slow-release traditional Chinese medicine cold compress for treating skin ulcers comprising the following components of Chinese herbal medicine raw materials: 10 parts of orange peel; 10 parts of willow bark; more than 10 parts; 5 parts of barley bran; 5 parts; 3 parts of golden flowers and grass; 3 parts of stone cassia; 1 part of calcined oyster; 1 part of chuanxiong;
  • the long-acting sustained-release traditional Chinese medicine cold application further comprises 5 parts of a gel matrix comprising 30% by weight of tragacanth, 40% by weight of konjac gum, 25% by weight of locust bean gum and 5% by weight of ⁇ -cyclodextrin. .
  • the long-acting sustained-release traditional Chinese medicine cold application further comprises 1 part of a transdermal enhancer comprising 40% by weight of wintergreen oil, 50% by weight of eucalyptus oil, 7% by weight of glycerin and 3% by weight of myristyl alcohol .
  • the above-mentioned Chinese herbal medicine raw material component is ground into a powder having a particle diameter of 100 ⁇ m, and then impregnated with ethanol, dynamically extracted and filtered, and then filled to obtain a burn-in spray preparation, and a cold application of the traditional Chinese medicine is prepared.
  • the powder was dynamically extracted with 90% by weight of ethanol, and 90% by weight of ethanol was 5 times the volume of the powder.
  • a long-acting slow-release traditional Chinese medicine cold compress for treating skin ulcers comprising the following parts by weight of a Chinese herbal medicine raw material component: 25 orange peel; 20 portions of willow bark; more than 20 parts; 17 parts of barley bran; 15 parts; 15 parts of golden flowers and grass; 15 parts of stone cassia; 2.5 parts of calcined oyster; 2 parts of Chuanxiong;
  • the long-acting sustained-release traditional Chinese medicine cold application further comprises 15 parts of a gel matrix comprising 60% by weight of tragacanth, 20% by weight of konjac gum, 15% by weight of locust bean gum and 5% by weight of ⁇ -cyclodextrin. .
  • the long-acting sustained-release traditional Chinese medicine cold application further comprises 5 parts of a transdermal enhancer comprising 60% by weight of wintergreen oil, 30% by weight of eucalyptus oil, 5% by weight of glycerin and 5% by weight of myristyl alcohol .
  • the above-mentioned Chinese herbal medicine raw material component is ground into a powder having a particle diameter of 500 ⁇ m, and then impregnated with ethanol, dynamically extracted and filtered, and then filled to obtain a burn-in spray preparation, and a cold application of the traditional Chinese medicine is prepared.
  • the powder was dynamically extracted with 90 wt% of ethanol, which was 8 times the volume of the powder.
  • a long-acting slow-release traditional Chinese medicine cold compress for treating skin ulcers comprising the following parts by weight of a Chinese herbal medicine raw material component: 20 orange peel; 15 portions of willow bark; 15 parts more; 10 parts of barley bran; 10 parts; 10 parts of golden flowers and grass; 10 parts of stone cassia; 2 parts of calcined oyster; 1.5 parts of Chuanxiong;
  • the long-acting sustained-release traditional Chinese medicine cold application further comprises 10 parts of a gel matrix comprising 50% by weight of tragacanth, 30% by weight of konjac gum, 12% by weight of locust bean gum and 8wt% of ⁇ -cyclodextrin. .
  • the long-acting sustained-release traditional Chinese medicine cold application further comprises 3 parts of a transdermal enhancer comprising 50% by weight of wintergreen oil, 40% by weight of eucalyptus oil, 6% by weight of glycerin and 4% by weight of myristyl alcohol .
  • the above-mentioned Chinese herbal medicine raw material component is ground into a powder having a particle diameter of 300 ⁇ m, and then impregnated with ethanol, dynamically extracted and filtered, and then filled to obtain a burn-in spray preparation, and a cold application of the traditional Chinese medicine is prepared.
  • the powder was dynamically extracted with 90% by weight of ethanol, and 90% by weight of ethanol was 7 times the volume of the powder.
  • a long-acting slow-release traditional Chinese medicine cold compress for treating skin ulcers comprising the following parts by weight of a Chinese herbal medicine raw material component: 12 orange peels; 12 willow skins; 17 parts more; 15 parts of barley bran; 7 parts; 5 parts of golden flower grass; 12 parts of stone cassia; 1.5 parts of calcined oyster; 1.2 parts of Chuanxiong;
  • the long-acting sustained-release traditional Chinese medicine cold application further comprises 7 parts of a gel matrix, the gel matrix comprising 40% by weight of tragacanth, 32% by weight of konjac gum, 23% by weight of locust bean gum and 5% by weight of ⁇ -cyclodextrin.
  • the long-acting sustained-release Chinese medicine cold application further comprises 2 parts of a transdermal enhancer comprising 48% by weight of wintergreen oil, 40% by weight of eucalyptus oil, 7% by weight of glycerin and 5% by weight of myristyl alcohol .
  • the above-mentioned Chinese herbal medicine raw material component is ground into a powder having a particle diameter of 200 ⁇ m, and then impregnated with ethanol, dynamically extracted and filtered, and then filled to obtain a burn-in spray preparation, and a cold application of the traditional Chinese medicine is prepared.
  • the powder was dynamically extracted with 90% by weight of ethanol, and 90% by weight of ethanol was 6 times the volume of the powder.
  • a long-acting slow-release traditional Chinese medicine cold compress for treating skin ulcers comprising the following parts by weight of a Chinese herbal medicine raw material component: 20 orange peel; 17 willow bark; 13 parts more; 7 parts of barley bran; 12 parts; 11 parts of golden flowers and grass; 5 parts of stone cassia; 2.2 parts of calcined oyster; 1.8 parts of Chuanxiong;
  • the long-acting sustained-release traditional Chinese medicine cold application further comprises 12 parts of a gel matrix comprising 35 wt% of tragacanth, 40 wt% of konjac gum, 22 wt% of locust bean gum and 3 wt% of ⁇ -cyclodextrin. .
  • the long-acting sustained-release traditional Chinese medicine cold application further comprises 2 parts of a transdermal enhancer comprising 55 wt% of wintergreen oil, 36 wt% of eucalyptus oil, 5 wt% of glycerol and 4 wt% of myristyl alcohol. .
  • the above-mentioned Chinese herbal medicine raw material component is ground into a powder having a particle diameter of 400 ⁇ m, and then subjected to ethanol impregnation, dynamic extraction and filtration, and then filled to obtain a burn-in spray preparation, and a cold application of the traditional Chinese medicine is prepared.
  • the powder was dynamically extracted with 90% by weight of ethanol, and 90% by weight of ethanol was 7 times the volume of the powder.
  • a rabbit skin ulcer model for full-thickness skin defects was treated using the above examples and comparative examples:
  • a model of rabbit skin ulcer with 24 full-thickness skin defects was randomly divided into 8 groups. After the scald spray prepared by the above examples and comparative examples, the wounds were observed and the wound healing rate was calculated.
  • wound healing rate (original wound area - unhealed area) * 100% / original wound area. See Table 1 and Table 2 for specific results.
  • the gel matrix of the long-acting and slow-release traditional Chinese medicine cold application is only prepared by using the tragacanth.
  • the mechanical strength is poor, and the external force is easily damaged. , seriously affecting the therapeutic effect of the active ingredients of traditional Chinese medicines carried by them.
  • the long-acting sustained-release traditional Chinese medicine cold application for treating skin ulcers can significantly shorten the healing time of skin ulcer wounds, has a high healing rate, and can effectively prevent scar formation on ulcer wounds.

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Abstract

一种治疗皮肤溃疡的长效缓释中药冷敷贴，按重量份计包括橘皮10-25份、柳枝皮10-20份、多依10-20份、大麦麸5-17份、苍耳子5-15份、金花草3-15份、石决明3-15份、煅牡蛎1-2.5份、川槿皮1-2份。该中药冷敷贴可持续稳定释放中药有效成分到溃疡病变区，且不会造成由于创面粘连对伤口造成的二次伤害，中药冷敷贴基质对溃疡面保持湿润环境，可促进溃疡的愈合。

Description

一种用于治疗皮肤溃疡的长效缓释中药冷敷贴 技术领域
本发明属于中药领域，涉及一种中药制剂及其制备方法，特别是涉及一种用于治疗皮肤溃疡的长效缓释中药冷敷贴。
背景技术
皮肤溃疡是由于各种原因引起的皮肤慢性感染性病变，是由于组织缺血、坏死引起的皮肤或黏膜缺损，由于局部营养状态差，血液循环障碍以及抵抗力低下，在此基础上易出现反复感染而形成的恶性循环。皮肤溃疡创面的治疗及愈合过程复杂，时间较长，创面愈合后可留有疤痕挛缩和功能障碍等后遗症。
现代医学研究认为，皮肤创面愈合是机体修复各种损伤造成的组织缺失，通过再生及修复等手段，以恢复机体组织结构及功能完整性的过程。顺利完成愈合过程的基础是多种愈合相关细胞生物学功能的正常发挥，并依赖细胞、细胞外基质及生长因子和细胞因子在内的可溶性介质之间的相互作用。在现有皮肤溃疡的治疗药物中，虽然西医的治疗技术一直在更新，但由于其作用机制单一，在长期治疗过程中，治疗效果一直不佳。由于皮肤溃疡伤病症成因复杂，机制特性多变，中药优势显著，并已取得了显著的突破，但还是存在各组分配伍不甚合理，治疗时间长，疗效慢等问题。
发明内容
针对上述不足之处，本发明的目的在于提供一种用于治疗皮肤溃疡的长效缓释中药冷敷贴，通过将其贴附于皮肤溃疡创面，包埋于凝胶基质中的中药有效成分可持续稳定释放到溃疡病变区，作用持久，并且在换药时既不会造成由于创面粘连对伤口造成的二次伤害，又保持了伤口的清洁卫生。此外，基质对溃疡面保持的湿润环境也进一步促进了溃疡的愈合。
本发明的技术方案概述如下：
一种用于治疗皮肤溃疡的长效缓释中药冷敷贴，其包括以下重量份的原 料组份：
Figure PCTCN2017108110-appb-000001
在上述中药冷敷贴中药配方中，橘皮、柳枝皮和多依共为君药，具有消毒、控制感染和疏通创面局部脉络血管的作用；大麦麸、苍耳子、金花草和石决明共为臣药，具有疏达脉络，祛腐生肌的作用；猪牙皂和煅牡蛎为佐药，具有收敛消肿，排出协浊的作用；川槿皮具有凉血止痒的功能,可有效缓解在修复损伤皮肤过程中出现的瘙痒症状。
优选的是，其中，所述中药冷敷贴还包括5-15重量份的凝胶基质，形成皮肤溃疡治疗的水凝胶辅料，既维持伤口愈合所需的湿润环境，又防止换药时，由于贴剂与创面粘连而对伤口造成的二次损伤。
优选的是，其中，所述中药冷敷贴还包括1-5重量份的透皮促进剂，促进中药有效成分穿透皮肤，充分发挥药效。
优选的是，其中，所述凝胶基质包括30-60wt％的黄芪胶、15～40wt％的魔芋胶、12-25wt％的槐豆胶和3-8wt％的α-环糊精，四种物质相互交联形成稳固的三维网络，制备得到的凝胶辅料既具有优良的透气透湿性，并且具有优异的拉伸缩强度和机械强度。
优选的是，其中，所述透皮促进剂包括40-60wt％的冬青油、30-50wt％的桉叶油、3-7wt％的甘油和2-5wt％的十四烷醇，四种物质相配合使用，发挥协同作用可有效渗入疤痕角质组织，促进中药贴剂有效成分的发挥。
优选的是，其中，所述原料组份碾成粉末后，再经乙醇浸渍、提取和过 滤后，制备得到中药冷敷贴。
优选的是，其中，所述粉末的粒径为100～500μm，所述提取为动态提取，在本申请文件中，原料粉末的粒径不需要太细，粒径为100～500μm即可实现有效成分的提取，不但降低了粉碎成本，还避免了因粉末过细带来的动态提取压力过高。
优选的是，其中，采用90wt％的乙醇对所述粉末进行动态提取，有效成分溶出速度快，溶出效率高。
优选的是，其中，在所述动态提取过程中，所述90wt％的乙醇是粉末体积的5～8倍，以保证中药有效成分的充分提取。
本发明的有益效果是：本发明提供的治疗皮肤溃疡的长效缓释中药冷敷贴，能显著缩短皮肤溃疡创面愈合的时间，愈合率高，且可有效防止溃疡创面形成疤痕。
具体实施方式
下面结合实施例对本发明做进一步的详细说明，以令本领域技术人员参照说明书文字能够据以实施。
实施例1
一种用于治疗皮肤溃疡的长效缓释中药冷敷贴，其包括以下重量份的中草药原料组份：橘皮10份；柳枝皮10份；多依10份；大麦麸5份；苍耳子5份；金花草3份；石决明3份；煅牡蛎1份；川槿皮1份；
其中，长效缓释中药冷敷贴还包括凝胶基质5份，所述凝胶基质包括30wt％的黄芪胶、40wt％的魔芋胶、25wt％的槐豆胶和5wt％的α-环糊精。
其中，长效缓释中药冷敷贴还包括透皮促进剂1份，所述透皮促进剂包括40wt％的冬青油、50wt％的桉叶油、7wt％的甘油和3wt％的十四烷醇。
取上述中草药原料组份碾成粒径为100μm的粉末，再经乙醇浸渍、动态提取和过滤后，灌装得到烧烫伤喷雾制剂，制备得到中药冷敷贴。在此制备方案中，采用90wt％的乙醇对所述粉末进行动态提取，90wt％的乙醇是粉末体积的5倍。
实施例2
一种用于治疗皮肤溃疡的长效缓释中药冷敷贴，其包括以下重量份的中草药原料组份：橘皮25份；柳枝皮20份；多依20份；大麦麸17份；苍耳子15份；金花草15份；石决明15份；煅牡蛎2.5份；川槿皮2份；
其中，长效缓释中药冷敷贴还包括凝胶基质15份，所述凝胶基质包括60wt％的黄芪胶、20wt％的魔芋胶、15wt％的槐豆胶和5wt％的α-环糊精。
其中，长效缓释中药冷敷贴还包括透皮促进剂5份，所述透皮促进剂包括60wt％的冬青油、30wt％的桉叶油、5wt％的甘油和5wt％的十四烷醇。
取上述中草药原料组份碾成粒径为500μm的粉末，再经乙醇浸渍、动态提取和过滤后，灌装得到烧烫伤喷雾制剂，制备得到中药冷敷贴。在此制备方案中，采用90wt％的乙醇对所述粉末进行动态提取，90wt％的乙醇是粉末体积的8倍。
实施例3
一种用于治疗皮肤溃疡的长效缓释中药冷敷贴，其包括以下重量份的中草药原料组份：橘皮20份；柳枝皮15份；多依15份；大麦麸10份；苍耳子10份；金花草10份；石决明10份；煅牡蛎2份；川槿皮1.5份；
其中，长效缓释中药冷敷贴还包括凝胶基质10份，所述凝胶基质包括50wt％的黄芪胶、30wt％的魔芋胶、12wt％的槐豆胶和8wt％的α-环糊精。
其中，长效缓释中药冷敷贴还包括透皮促进剂3份，所述透皮促进剂包括50wt％的冬青油、40wt％的桉叶油、6wt％的甘油和4wt％的十四烷醇。
取上述中草药原料组份碾成粒径为300μm的粉末，再经乙醇浸渍、动态提取和过滤后，灌装得到烧烫伤喷雾制剂，制备得到中药冷敷贴。在此制备方案中，采用90wt％的乙醇对所述粉末进行动态提取，90wt％的乙醇是粉末体积的7倍。
实施例4
一种用于治疗皮肤溃疡的长效缓释中药冷敷贴，其包括以下重量份的中草药原料组份：橘皮12份；柳枝皮12份；多依17份；大麦麸15份；苍耳子7份；金花草5份；石决明12份；煅牡蛎1.5份；川槿皮1.2份；
其中，长效缓释中药冷敷贴还包括凝胶基质7份，所述凝胶基质包括 40wt％的黄芪胶、32wt％的魔芋胶、23wt％的槐豆胶和5wt％的α-环糊精。
其中，长效缓释中药冷敷贴还包括透皮促进剂2份，所述透皮促进剂包括48wt％的冬青油、40wt％的桉叶油、7wt％的甘油和5wt％的十四烷醇。
取上述中草药原料组份碾成粒径为200μm的粉末，再经乙醇浸渍、动态提取和过滤后，灌装得到烧烫伤喷雾制剂，制备得到中药冷敷贴。在此制备方案中，采用90wt％的乙醇对所述粉末进行动态提取，90wt％的乙醇是粉末体积的6倍。
实施例5
一种用于治疗皮肤溃疡的长效缓释中药冷敷贴，其包括以下重量份的中草药原料组份：橘皮20份；柳枝皮17份；多依13份；大麦麸7份；苍耳子12份；金花草11份；石决明5份；煅牡蛎2.2份；川槿皮1.8份；
其中，长效缓释中药冷敷贴还包括凝胶基质12份，所述凝胶基质包括35wt％的黄芪胶、40wt％的魔芋胶、22wt％的槐豆胶和3wt％的α-环糊精。
其中，长效缓释中药冷敷贴还包括透皮促进剂2份，所述透皮促进剂包括55wt％的冬青油、36wt％的桉叶油、5wt％的甘油和4wt％的十四烷醇。
取上述中草药原料组份碾成粒径为400μm的粉末，再经乙醇浸渍、动态提取和过滤后，灌装得到烧烫伤喷雾制剂，制备得到中药冷敷贴。在此制备方案中，采用90wt％的乙醇对所述粉末进行动态提取，90wt％的乙醇是粉末体积的7倍。
为了说明本发明的效果，发明人提供比较实验如下：
<比较例1>
在制备长效缓释中药冷敷贴时，凝胶基质中仅添加黄芪胶，其余参数与实例1中的完全相同，工艺过程也完全相同。
<比较例2>
在制备长效缓释中药冷敷贴时，凝胶基质中不添加α-环糊精，其余参数与实例1中的完全相同，工艺过程也完全相同。
<比较例3>
在制备长效缓释中药冷敷贴时，透皮促进剂中不添加十四烷醇，其余参数与实例2中的完全相同，工艺过程也完全相同。
对全层皮肤缺损的家兔皮肤溃疡模型使用上述实例及比较例进行治疗试验：
选取24只全层皮肤缺损的家兔皮肤溃疡模型，随机分成8组，分别采用上述实例及比较例制备的烫伤喷雾剂给药后，观察创面的大体改变，并计算创面愈合率，
其中，创面愈合情况率的计算方法：采用透明膜描记判断创面愈合的情况。具体公示为：创面愈合率＝(原始创面面积-未愈合面积)*100％/原始创面面积。具体结果参见表1和表2。
表1 各实例及比较例对家兔皮肤溃疡模型的治疗结果
Figure PCTCN2017108110-appb-000002
比较例1与实例相比，长效缓释中药冷敷贴的凝胶基质仅选用黄芪胶制备，在贴附于溃疡创面用于修复受损皮肤时，存在机械强度差，易因受到外力受到破坏，严重影响了其承载的中药有效成分的治疗效果。
比较例2与实例相比，长效缓释中药冷敷贴的凝胶基质没有选用α-环糊精，中药冷敷贴的修复治疗效果变差，并且冷敷贴在贴附于溃疡创面的过程中，也存在轻微破损现象，这说明α-环糊精的添加可显著提高凝胶基质的稳定性。
比较例3与实例相比，长效缓释中药冷敷贴的透皮促进剂中不添加十四烷醇，制备得到的中药冷敷贴复破损皮肤的效果显著变差，这说明十四烷醇可有效促进软化疤痕中药有效成分的吸收。
可见，本发明提供的治疗皮肤溃疡的长效缓释中药冷敷贴，能显著缩短皮肤溃疡创面愈合的时间，愈合率高，且可有效防止溃疡创面形成疤痕。
尽管本发明的实施方案已公开如上，但其并不仅仅限于说明书和实施方式中所列运用，它完全可以被适用于各种适合本发明的领域，对于熟悉本领域的人员而言，可容易地实现另外的修改，因此在不背离权利要求及等同范围所限定的一般概念下，本发明并不限于特定的细节。

Claims (9)

  1. 一种用于治疗皮肤溃疡的长效缓释中药冷敷贴，其特征在于，包括以下重量份的原料组份：
    Figure PCTCN2017108110-appb-100001
  2. 如权利要求1所述的用于治疗皮肤溃疡的长效缓释中药冷敷贴，其特征在于，所述中药冷敷贴还包括5-15重量份的凝胶基质。
  3. 如权利要求2所述的用于治疗皮肤溃疡的长效缓释中药冷敷贴，其特征在于，所述中药冷敷贴还包括1-5重量份的透皮促进剂。
  4. 如权利要求2所述的用于治疗皮肤溃疡的长效缓释中药冷敷贴，其特征在于，所述凝胶基质包括30-60wt％的黄芪胶、15～40wt％的魔芋胶、12-25wt％的槐豆胶和3-8wt％的α-环糊精。
  5. 如权利要求3所述的用于治疗皮肤溃疡的长效缓释中药冷敷贴，其特征在于，所述透皮促进剂包括40-60wt％的冬青油、30-50wt％的桉叶油、3-7wt％的甘油和2-5wt％的十四烷醇。
  6. 如权利要求1所述的用于治疗皮肤溃疡的长效缓释中药冷敷贴，其特征在于，所述原料组份碾成粉末后，再经乙醇浸渍、提取和过滤后，制备得到中药冷敷贴。
  7. 如权利要求6所述的用于治疗皮肤溃疡的长效缓释中药冷敷贴，其特征在于，所述粉末的粒径为100～500μm，所述提取为动态提取。
  8. 如权利要求7所述的用于治疗皮肤溃疡的长效缓释中药冷敷贴，其特 征在于，采用90wt％的乙醇对所述粉末进行动态提取。
  9. 如权利要求8所述的用于治疗皮肤溃疡的长效缓释中药冷敷贴，其特征在于，在所述动态提取过程中，所述90wt％的乙醇是粉末体积的5～8倍。
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CN105078645A (zh) * 2014-05-12 2015-11-25 天津卓普医疗器械有限公司 一种以水凝胶为基质的冷敷贴剂及制备方法

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