WO2019080114A1 - 一种软化疤痕的中药贴剂 - Google Patents

一种软化疤痕的中药贴剂

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Publication number
WO2019080114A1
WO2019080114A1 PCT/CN2017/108109 CN2017108109W WO2019080114A1 WO 2019080114 A1 WO2019080114 A1 WO 2019080114A1 CN 2017108109 W CN2017108109 W CN 2017108109W WO 2019080114 A1 WO2019080114 A1 WO 2019080114A1
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WIPO (PCT)
Prior art keywords
parts
chinese medicine
weight
scar
patch
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PCT/CN2017/108109
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English (en)
French (fr)
Inventor
吴克
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江苏奇力康皮肤药业有限公司
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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/CN2017/108109 priority Critical patent/WO2019080114A1/zh
Priority to CN201780001811.5A priority patent/CN108235684B/zh
Publication of WO2019080114A1 publication Critical patent/WO2019080114A1/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)
    • A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • 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)
    • 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)
    • A61K36/48—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)
    • A61K36/49—Fagaceae (Beech family), e.g. oak or chestnut
    • 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)
    • A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
    • A61K36/605—Morus (mulberry)
    • 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
    • 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
    • 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
    • A61K47/44—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
    • 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
    • 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 patch and a preparation method thereof, in particular to a traditional Chinese medicine patch for softening scar.
  • the stress response and the inflammatory reaction of the wound cause the abnormal growth factor of the stromal layer, which induces the degeneration of deep stromal cells (fibroblasts, myofibroblasts) into scar cells and scars.
  • the scar cells themselves do not have the ability to divide and proliferate, and will die with their own metabolism, but because the cell growth factor continues to induce stromal cells to transform into scar cells, supplementing the scar cells that continue to metabolize, the scar tissue is maintained, and Abnormal proliferation will occur.
  • the repair process of scars is based on the normal functioning of various related cell biological functions and on the interaction between cells, extracellular matrices and soluble media such as growth factors and cytokines.
  • the existing scar repair treatment drugs although the therapeutic technology of Western medicine has been updated, due to its single mechanism of action, the treatment effect has been poor in the long-term treatment process. Due to the complex causes of scar disease and the variable nature of the mechanism, the advantages of traditional Chinese medicine are remarkable, especially in the transdermal drug delivery system.
  • the percutaneous drug delivery system has no "first pass effect" of the liver, is not destroyed by the digestive enzymes of the gastrointestinal tract, has a long duration of action, reduces the side effects and adverse reactions of the drug, and maintains a stable and long-lasting blood drug concentration to improve the therapeutic effect.
  • the object of the present invention is to provide a traditional Chinese medicine patch for softening scars, which can effectively penetrate the skin barrier layer and introduce into the deep layer of the skin to fully exert the softening scar and ventilate blood of the traditional Chinese medicine patch. , discharge turbidity, correct the role of damaged parts of the skin.
  • a traditional Chinese medicine patch for softening scars comprising the following raw material components by weight:
  • the Chinese medicine patch further comprises 2-6 parts by weight of a transdermal enhancer to promote the penetration of the active ingredient of the traditional Chinese medicine into the skin and repair the scar.
  • 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, and then impregnated with ethanol, extracted and filtered to prepare a softened scar patch.
  • 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 present invention provides a softening scar-based traditional Chinese medicine patch, which can soften and degrade scar tissue, and further repair and regenerate the skin damaged by scar, desalinate and repair scars, especially old scars close to normal skin color. The effect is remarkable.
  • a traditional Chinese medicine patch for softening scars comprising the following raw material components: 10 parts of orange peel; 10 parts of stretched grass; 10 parts of eggplant; 5 parts of mulberry; 5 parts of chestnut leaves; 3 parts; 3 parts of Cassia; 1.5 parts of pig tooth soap; 1.5 parts of calcined oyster; 1 part of Chuanxiong, 2 parts of transdermal enhancer.
  • the transdermal enhancer includes 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 raw material component was ground into a powder having a particle diameter of 100 ⁇ m, and then impregnated with ethanol, extracted and filtered to prepare a softened scar patch.
  • the powder is dynamically extracted by using 90% by weight of ethanol, and 90% by weight of ethanol is 5 times the volume of the powder.
  • a traditional Chinese medicine patch for softening scars comprising the following raw material components: 20 parts of orange peel; 15 parts of stretched grass; 15 parts of eggplant; 12 parts of mulberry; 12 parts of chestnut leaves; 8 parts of stone cassia; 5 parts of pig tooth soap; 5 parts of calcined oyster; 3 parts of Chuanxiong, 6 parts of transdermal enhancer.
  • the transdermal enhancer includes 60% by weight of wintergreen oil, 35% by weight of eucalyptus oil, 3% by weight of glycerin, and 2% by weight of myristyl alcohol.
  • the above raw material component was ground into a powder having a particle diameter of 500 ⁇ m, and then impregnated with ethanol, extracted and filtered to prepare a softened scar patch.
  • the powder is dynamically extracted by using 90% by weight of ethanol, and 90% by weight of ethanol is 8 times the volume of the powder.
  • a traditional Chinese medicine patch for softening scars comprising the following raw material components: 15 parts of orange peel; 12 parts of stretched grass; 12 parts of eggplant; 9 parts of mulberry; 9 parts of chestnut leaves; 7 parts; 5 parts of stone cassia; 3 parts of pig tooth soap; 3 parts of calcined oyster; 2 parts of Chuanxiong, 4 parts of transdermal enhancer.
  • the transdermal enhancer includes 50% by weight of wintergreen oil, 42% by weight of eucalyptus oil, 5% by weight of glycerin, and 3% by weight of myristyl alcohol.
  • the above raw material component was ground into a powder having a particle diameter of 300 ⁇ m, and then impregnated with ethanol, extracted and filtered to prepare a softened scar patch.
  • the powder is dynamically extracted by using 90% by weight of ethanol, and 90% by weight of ethanol is 6 times the volume of the powder.
  • a traditional Chinese medicine patch for softening scars comprising the following raw material components: 12 parts of orange peel; 11 parts of stretched grass; 11 parts of eggplant; 10 parts of mulberry; 10 parts of chestnut leaves; 8 parts; 7 parts of stone cassia; 4 parts of pig tooth soap; 4 parts of calcined oyster; 2.5 parts of Chuanxiong, 3 parts of transdermal enhancer.
  • the transdermal enhancer includes 45 wt% of wintergreen oil, 45 wt% of eucalyptus oil, 6 wt% of glycerin, and 4 wt% of myristyl alcohol.
  • the above raw material component was ground into a powder having a particle diameter of 200 ⁇ m, and then impregnated with ethanol, extracted and filtered to prepare a softened scar patch.
  • the powder is dynamically extracted by using 90% by weight of ethanol, and 90% by weight of ethanol is 7 times the volume of the powder.
  • a traditional Chinese medicine patch for softening scars comprising the following raw material components: 18 parts of orange peel; 14 parts of stretched grass; 14 parts of eggplant; 6 parts of mulberry; 6 parts of chestnut leaves; 5 parts; 5 parts of stone cassia; 2 parts of pig tooth soap; 2 parts of calcined oyster; 1.5 parts of Chuanxiong, 5 parts of transdermal enhancer.
  • the transdermal enhancer includes 55 wt% of wintergreen oil, 35 wt% of eucalyptus oil, 6 wt% of glycerin, and 4 wt% of myristyl alcohol.
  • the above raw material component was ground into a powder having a particle diameter of 400 ⁇ m, and then impregnated with ethanol, extracted and filtered to prepare a softened scar patch.
  • the powder is dynamically extracted by using 90% by weight of ethanol, 90% by weight
  • the ethanol is 7 times the volume of the powder.
  • the nude mice scar model was treated with the above examples and comparative examples:
  • a total of 35 nude mouse scar models were randomly divided into 7 groups, and the wound area was observed after administration of the softened scar Chinese medicine patch prepared in the above examples and comparative examples. See Table 1 for the specific results.
  • Comparative Example 1 Compared with the example, the transdermal enhancer is not added to the traditional Chinese medicine patch formulation, and the effective component of the traditional Chinese medicine which reaches the body through the skin is difficult to achieve an effective therapeutic concentration and therapeutic effect due to the resistance of the stratum corneum of the skin skin.
  • Comparative Example 2 Compared with the example, the tetradecyl alcohol was not added to the traditional Chinese medicine patch preparation, and the prepared traditional Chinese medicine patch softened and repaired the scar significantly, which indicates that the myristyl alcohol can effectively promote the softening scar active ingredient of Chinese medicine. absorb.
  • the invention provides a traditional Chinese medicine patch for softening scar, which can soften and degrade scar tissue, further repair and regenerate the skin damaged by scar, and dilute and repair scars, especially old ones.
  • the mark is close to the normal skin tone and the effect is remarkable.

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Abstract

一种软化疤痕的中药贴剂，包括以下重量份的原料组分：陈皮10-20份、伸筋草10-15份、茄皮10-15份、桑枝5-12份、栗树叶5-12份、多依3-10份、石决明3-8份、猪牙皂1.5-5份、煅牡蛎1.5-5份、木槿皮1-3份。所述中药贴剂具有软化疤痕、疏通气血、排出邪浊、修正皮肤受损部分的作用。

Description

一种软化疤痕的中药贴剂 技术领域
本发明属于中药领域，涉及一种中药贴剂及其制备方法，特别是涉及一种软化疤痕的中药贴剂。
背景技术
当人体皮肤深层受到创伤后，应激反应及创面炎症反应导致基质层异常增多的生长因子，诱使皮肤深层基质细胞(成纤维细胞、肌成纤维细胞)变性转化疤痕细胞，产生疤痕。并且，虽然疤痕细胞自身不具备分裂增生能力，并会随着自身代谢消亡，但由于细胞生长因子不断诱使基质细胞转化为疤痕细胞，补充不断代谢消亡的疤痕细胞，所以疤痕组织得以维持，并会出现异常增生。
疤痕的修复过程的基础是多种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。在现有疤痕修复治疗药物中，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。由于疤痕病症成因复杂，机制特性多变，中药优势显著，尤其在经皮给药系统方面已取得了显著的突破。经皮给药系统无肝脏的“首过效应”，不受胃肠道消化酶的破坏，有维持较长作用时间、降低药物毒副作用和不良反应、维持稳定而持久的血药浓度从而提高疗效的优点。但是由于大多数药物透过皮肤的速度和效率都较低，从而使透皮吸收药物在皮肤科临床中的治疗效果不太理想。目前，中药合理配伍和如何加强药物的透皮吸收是现在的研究热点。
发明内容
针对上述不足之处，本发明的目的在于提供一种软化疤痕的中药贴剂，其能使中药有效成分顺利穿透皮肤屏障层,导入皮肤深层，以充分发挥中药贴剂软化疤痕、疏通气血、排出协浊、修正皮肤受损部分的作用。
本发明的技术方案概述如下：
一种软化疤痕的中药贴剂，其包括以下重量份的原料组份：
Figure PCTCN2017108109-appb-000001
在上述软化疤痕的中药贴剂配方中，橘皮、伸筋草和茄皮共为君药，具有穿凿肿物，软化疤痕和疏通创面局部脉络血管的作用；桑枝、栗树叶、薰衣草和石决明共为臣药，具有化瘀生肌，促进皮肤修复的功能；猪牙皂和煅牡蛎为佐药，具有消肌导滞，排出协浊的作用；川槿皮具有凉血止痒的功能,可有效缓解在软化疤痕，损伤皮肤修复过程中出现的瘙痒症状。
优选的是，其中，所述中药贴剂中还包括2-6重量份的透皮促进剂，促进中药有效成分穿透皮肤，修复疤痕。
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，制备得到软化疤痕贴剂。
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：本发明提供的一种软化疤痕的中药贴剂，其可以软化和降解疤痕组织，并进一步对疤痕位置损伤皮肤进行修复再生，淡化和修复疤痕尤其是陈旧疤痕接近正常肤色，效果显著。
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
一种软化疤痕的中药贴剂，其包括以下重量份的原料组份：橘皮10份；伸筋草10份；茄皮10份；桑枝5份；栗树叶5份；多依3份；石决明3份；猪牙皂1.5份；煅牡蛎1.5份；川槿皮1份,透皮促进剂2份。
其中，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。
取上述原料组份碾成粒径为100μm的粉末后，再经乙醇浸渍、提取和过滤后，制备得到软化疤痕贴剂。
其中，上述方案中，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
一种软化疤痕的中药贴剂，其包括以下重量份的原料组份：橘皮20份；伸筋草15份；茄皮15份；桑枝12份；栗树叶12份；多依10份；石决明8份；猪牙皂5份；煅牡蛎5份；川槿皮3份,透皮促进剂6份。
其中，透皮促进剂包括60wt％的冬青油、35wt％的桉叶油、3wt％的甘油和2wt％的十四烷醇。
取上述原料组份碾成粒径为500μm的粉末后，再经乙醇浸渍、提取和过滤后，制备得到软化疤痕贴剂。
其中，上述方案中，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
一种软化疤痕的中药贴剂，其包括以下重量份的原料组份：橘皮15份；伸筋草12份；茄皮12份；桑枝9份；栗树叶9份；多依7份；石决明5份；猪牙皂3份；煅牡蛎3份；川槿皮2份,透皮促进剂4份。
其中，透皮促进剂包括50wt％的冬青油、42wt％的桉叶油、5wt％的甘油和3wt％的十四烷醇。
取上述原料组份碾成粒径为300μm的粉末后，再经乙醇浸渍、提取和过滤后，制备得到软化疤痕贴剂。
其中，上述方案中，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4
一种软化疤痕的中药贴剂，其包括以下重量份的原料组份：橘皮12份；伸筋草11份；茄皮11份；桑枝10份；栗树叶10份；多依8份；石决明7份；猪牙皂4份；煅牡蛎4份；川槿皮2.5份,透皮促进剂3份。
其中，透皮促进剂包括45wt％的冬青油、45wt％的桉叶油、6wt％的甘油和4wt％的十四烷醇。
取上述原料组份碾成粒径为200μm的粉末后，再经乙醇浸渍、提取和过滤后，制备得到软化疤痕贴剂。
其中，上述方案中，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5
一种软化疤痕的中药贴剂，其包括以下重量份的原料组份：橘皮18份；伸筋草14份；茄皮14份；桑枝6份；栗树叶6份；多依5份；石决明5份；猪牙皂2份；煅牡蛎2份；川槿皮1.5份,透皮促进剂5份。
其中，透皮促进剂包括55wt％的冬青油、35wt％的桉叶油、6wt％的甘油和4wt％的十四烷醇。
取上述原料组份碾成粒径为400μm的粉末后，再经乙醇浸渍、提取和过滤后，制备得到软化疤痕贴剂。
其中，上述方案中，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>
在制备软化疤痕的中药贴剂时，不添加透皮促进剂，其余参数与实例2中的完全相同，工艺过程也完全相同。
<比较例2>
在制备软化疤痕的中药贴剂时，不添加十四烷醇，其余参数与实例3中的完全相同，工艺过程也完全相同。
对裸鼠疤痕模型使用上述实例及比较例进行治疗试验：
选取35只裸鼠疤痕模型，随机分成7组，分别采用上述实例及比较例制备的软化疤痕中药贴剂给药后，观察创面面积的变化。具体结果参见表1。
表1 各实例及比较例裸鼠疤痕模型的治疗结果
Figure PCTCN2017108109-appb-000002
比较例1与实例相比，中药贴剂配方中不添加透皮促进剂，由于皮肤皮肤角质层的阻力，经皮到达体内的中药有效成分很难达到有效的治疗浓度和治疗效果。
比较例2与实例相比，中药贴剂配方中不添加十四烷醇，制备得到的中药贴剂软化修复疤痕的效果显著变差，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。
本发明提供的一种软化疤痕的中药贴剂，其可以软化和降解疤痕组织，并进一步对疤痕位置损伤皮肤进行修复再生，淡化和修复疤痕尤其是陈旧疤 痕接近正常肤色，效果显著。
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 (7)

  1. 一种软化疤痕的中药贴剂，其特征在于，包括以下重量份的原料组份：
    Figure PCTCN2017108109-appb-100001
  2. 如权利要求1所述的软化疤痕的中药贴剂，其特征在于，所述中药贴剂中还包括2-6重量份的透皮促进剂。
  3. 如权利要求2所述的软化疤痕的中药贴剂，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。
  4. 如权利要求1所述的软化疤痕的中药贴剂，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，制备得到软化疤痕贴剂。
  5. 如权利要求4所述的软化疤痕的中药贴剂，其特征在于，所述粉末的粒径为100～500μm，所述提取为动态提取。
  6. 如权利要求5所述的软化疤痕的中药贴剂，其特征在于，采用90wt％的乙醇对所述粉末进行动态提取。
  7. 如权利要求6所述的软化疤痕的中药贴剂，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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