WO2013107206A1 - Chinese herbal medicine composition for treating diabetic foot - Google Patents

Chinese herbal medicine composition for treating diabetic foot Download PDF

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Publication number
WO2013107206A1
WO2013107206A1 PCT/CN2012/084295 CN2012084295W WO2013107206A1 WO 2013107206 A1 WO2013107206 A1 WO 2013107206A1 CN 2012084295 W CN2012084295 W CN 2012084295W WO 2013107206 A1 WO2013107206 A1 WO 2013107206A1
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parts
medicine composition
chinese medicine
traditional chinese
diabetic foot
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PCT/CN2012/084295
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French (fr)
Chinese (zh)
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孙万奎
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Sun Wankui
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/63Arthropods
    • A61K35/646Arachnids, e.g. spiders, scorpions, ticks or mites
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/36Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/63Arthropods
    • A61K35/648Myriapods, e.g. centipedes or millipedes
    • 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)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • 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)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/286Carthamus (distaff thistle)
    • 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)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/739Sanguisorba (burnet)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/02Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/02Drugs for disorders of the nervous system for peripheral neuropathies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Definitions

  • Description of the invention relates to a traditional Chinese medicine composition for treating diabetic foot
  • the present invention relates to a traditional Chinese medicine composition for treating diabetic foot, and belongs to the field of traditional Chinese medicine.
  • Diabetic foot refers to the destruction of lower extremity infection, ulceration, and/or deep tissue caused by diabetic patients with neuropathy and various degrees of peripheral vascular disease.
  • DF Diabetic foot
  • the "foot” is the farthest and the most occluded, causing edema, blackening, rot, necrosis, and dislocation.
  • Diabetic foot is clinically divided into neuropathy type, arterial ischemia type, and mixed type (i.e., neuropathy and arterial ischemia simultaneously exist).
  • High risk factors for ulceration and gangrene in diabetic foot include peripheral vascular neuropathy, autonomic neuropathy, loss of protection, microvascular disease, metabolic factors, history of foot ulcers, foot deformity, convulsions, blindness, and severe vision loss.
  • senile ischemic diabetic foot is particularly common, mainly caused by peripheral vascular neuropathy; capillary basement membrane Thickening is due to stenosis of the lumen, rough intima, decreased blood vessel elasticity and contraction, poor blood flow, tissue ischemia and hypoxia, poor red blood cell deformability, abnormal blood rheology, vascular endothelial injury and other factors easily cause capillary
  • the vascular basement membrane is thickened, and there is deposition of a transparent substance, which causes microvascular lesion pressure.
  • Diabetic patients cause neurotrophic disorders and ischemic neuritis due to vascular lesions.
  • Diabetic foot is a Chinese medicine "dislocation" category, the motherland medicine believes that the core cause of diabetic foot is qi deficiency, yang deficiency, cold qi, qi deficiency, can not be handsome, yang can not be warm, cold stagnation, blood stagnant, long-term limb Necrosis is dislocated.
  • the main drugs for treating diabetic foot are: 1. Improve microcirculation treatment, mainly including anisodamine, prostaglandin El, traditional Chinese medicine preparation compound Danshen injection, etc.; 2. Reduce blood coagulation, mainly Pan Shengding, aspirin, warfarin, Pei Da, etc.; 3, anti-infective treatment, mainly applied broad-spectrum antibiotics and metronidazole; 4, improve neuropathic drugs, such as epasita.
  • the above drugs can only help treat diabetic foot, can not cure the symptoms, and have large side effects, which easily lead to other complications.
  • Chinese patent document CN101757152A discloses a traditional Chinese medicine composition for treating ischemic diabetic foot, ginseng, leeches, earthworms, frankincense, red peony, scent, sandalwood, scorpion, scorpion, scorpion, Borneol, jujube kernel composition, with the effect of replenishing qi and activating blood circulation, resolving phlegm and blood stasis, 3 ⁇ 4 composition of the product name is Tongxinluo Capsule, used for coronary heart disease, angina pectoris is a deficiency of heart and blood stasis, although it is ischemic Diabetic foot has a certain effect, but it has a slow onset and is ineffective for neuropathic and mixed diabetic foot.
  • the technical problem to be solved by the present invention is that the traditional Chinese medicine composition for treating diabetic foot in the prior art has a slow onset of action, and provides a kind of effect on the problem of ineffectiveness of neuropathic type, arterial ischemic type, and mixed type diabetic foot.
  • Fast a traditional Chinese medicine composition effective for neuropathic, arterial ischemic, mixed diabetic foot and a preparation method thereof.
  • the present invention provides a traditional Chinese medicine composition for treating diabetic foot, the weight of the raw material of the composition is: 1-30 parts of whole glutinous rice, 1-30 parts of medusa, 1-30 parts of medlar, 1-20 parts of borneol, 1-20 parts of eucalyptus, 1-20 parts of pangolin, 1-20 parts of castor, 1-20 parts of mantle, 1-20 parts of safflower.
  • the preferred parts of the drug substance of the traditional Chinese medicine composition of the present invention are: 2-20 parts of whole glutinous rice, 2-20 parts of medusa, ⁇ 2- 20 parts, 2-10 parts of borneol, 2-10 parts of sorghum 2-10 parts of pangolin, 2-10 parts of castor, 2-10 parts of mantle, 2-10 parts of safflower.
  • the most preferred parts of the traditional Chinese medicine composition of the present invention are: 1 part, 1 part of medusa, 1 part of medlar, 1 part of borneol, 1 part of eucalyptus, 1 part of pangolin, 1 part of castor bean. , 1 part of the cellar, 1 part of safflower.
  • the traditional Chinese medicine composition of the present invention can be formulated into a pill, a tablet, a capsule, a syrup, a granule, and a paste.
  • the substrate selected for the preparation of the traditional Chinese medicine composition is one or more of eucalyptus oil, petrolatum, and eucalyptus oil.
  • the preparation method of the traditional Chinese medicine composition of the present invention comprises the following steps:
  • the present invention also relates to the use of the traditional Chinese medicine composition for the preparation of a medicament for treating diabetic foot.
  • the principles and methods for treating diabetic foot in Chinese medicine mainly include detoxification, phlegm and stasis, promoting blood circulation and removing blood stasis, and warming
  • Mito is flat, tastes salty, poisonous, into the foot Quyin liver meridian, with dampness, detoxification, astringent, antiseptic effect; phlegm temperature, taste spicy, toxic, liver, spleen and lung, spleen and phlegm, phlegm and blood stasis, Tongluo analgesic effect;
  • the combination of Mito enhances the efficacy of clearing away heat and detoxifying, relieving collaterals and relieving pain.
  • cool, sweet and bitter, heart, liver, with dilation, detoxification, eliminate phlegm; pangolin slightly cold, taste salty, with blood circulation, eliminate the effect of sputum; castor Ping, sweetine, to the large intestine, lung, with swelling and detoxification, diarrhea and stagnation; cellar cold, bitter acid, liver, lung, kidney, large intestine, with cooling blood to stop bleeding, detoxification
  • the effect of reducing swelling and soreness; safflower is warm, fragrant, heart-to-heart, liver, has the effect of activating blood circulation, dispersing phlegm and relieving pain, and is adjunctive with Datun, Pangolin, Castor, and Mantle. ⁇ , blood circulation, cooling blood, swelling and detoxification, analgesic effect; borneol is cool, tastes hard, heart, lung, with the effect of phlegm ⁇ , in-depth treatment, strong penetration, can promote the absorption of the active ingredients of the drug, and act on the affected area for
  • the above nine herbs are used together to play the role of clearing away heat and detoxifying, phlegm and stasis, promoting blood circulation and removing blood stasis, warming meridians and collaterals, reducing swelling and relieving pain.
  • neuropathy arterial ischemia, mixed type diabetic foot, syndrome Muscle atrophy, foot deformity, foot skin infections, purulent, cleft palate, ulcers, finger ulcers, gangrene, etc. are effective.
  • the present invention has the following advantages:
  • the invention selects whole glutinous rice, medusa, medlar, borneol, medlar, pangolin, castor bean, mantle, safflower as raw materials, the raw materials are easy to obtain and the cost is low, and the heat and detoxification are synergistically exerted through various medicinal materials.
  • phlegm and stasis promoting blood circulation and removing blood stasis, warming meridians and collaterals, reducing swelling and relieving pain, for treating neuropathic type, arterial ischemic type, mixed type diabetic foot, syndrome of foot muscle atrophy, foot deformity, foot skin infection and suppuration, Cleft palate, ulcer, finger ulcer, gangrene, both symptoms and symptoms, and no toxic side effects, patients are not easy to relapse after use, to avoid the side effects caused by Western medicine treatment of diabetic foot and the great pain caused by amputation.
  • the administration method is as follows: The ointment prepared in Example 3 is applied to the affected part of the patient.
  • Treatment 15 days for a course of treatment, once a day.

Abstract

A Chinese herbal medicine composition for treating diabetic foot, consisting of the following raw material medicines in parts by weight: 1-30 parts of scorpion, 1-30 parts of lithargite, 1-30 parts of centipede, 1-20 parts of borneol, 1-20 parts of cirsium japonicum, 1-20 parts of pangolin, 1-20 parts of castor beans, 1-20 parts of garden burnet, and 1-20 parts of safflower. The composition has the effects of clearing heat and detoxicating, eliminating necrotic tissue and promoting granulation, stimulating blood circulation and removing blood stasis, warming and activating arteries and veins, and reducing swelling and stopping pain, and is used to treat nerve patho-type, artery ischemia-type and mixed-type diabetic foot with the symptoms of foot muscular atrophy, deformity, skin infection, purulence, rhagades and ulcers, and toe tip ulcers and gangrene.

Description

说明书 一种用于治疗糖尿病足的中药组合物 技术领域  Description of the invention relates to a traditional Chinese medicine composition for treating diabetic foot
[0001] 本发明涉及一种用于治疗糖尿病足的中药组合物, 属于中药领域。  [0001] The present invention relates to a traditional Chinese medicine composition for treating diabetic foot, and belongs to the field of traditional Chinese medicine.
背景技术 Background technique
[0002] 糖尿病足 (diabetic foot, DF ) 是指糖尿病患者 ώ于合并神经病变及各种不同程度末 梢血管病变而导致下肢感染、 溃疡形成和 (或) 深部组织的破坏。 在临床上, 由于糖尿病患 者长期受到高血糖的影响, 下肢血管硬化、 血管壁增厚、 弹性下降, 血管容易形成血栓, 并 集结成斑块, 而造成下肢血管闭塞、 支端神经损伤, 从而造成下肢组织病变。 而 "足"离心 脏最远, 闭塞现象最严重, 从而引发水肿、 发黑、 腐烂、 坏死, 形成脱疽, 是糖尿病慢性并 发症之一, 也是导致糖尿病病人致残死亡的主要原因之一。 主要临床表现为足部溃疡和坏 疽, 严重者需要截肢, 截肢率高达 40%。 中国国内糖尿病病人并发足坏疽的约占 0.9%〜 1.7% , 60 岁以上的老年病人并发糖尿病足坏疽的占 2.8%〜14.5% , 国内本病的截肢率 21%〜66%。  [0002] Diabetic foot (DF) refers to the destruction of lower extremity infection, ulceration, and/or deep tissue caused by diabetic patients with neuropathy and various degrees of peripheral vascular disease. Clinically, because diabetic patients have long been affected by hyperglycemia, lower extremity arteriosclerosis, thickening of blood vessel wall, and decreased elasticity, blood vessels are prone to thrombosis, and they form plaques, which cause vascular occlusion of the lower extremities and damage of the branch nerves. Causes lower extremity tissue lesions. The "foot" is the farthest and the most occluded, causing edema, blackening, rot, necrosis, and dislocation. It is one of the chronic complications of diabetes and one of the leading causes of disability in diabetic patients. The main clinical manifestations are foot ulcers and gangrene. In severe cases, amputation is required and the amputation rate is as high as 40%. In China, the proportion of diabetic patients with gangrene is about 0.9%~1.7%. The elderly patients over 60 years old with diabetes gangrene account for 2.8%~14.5%, and the amputation rate of this disease is 21%~66%.
[0003】 糖尿病足临床上分为神经病变型、 动脉缺血型、 混合型 (即神经病变和动脉缺血同 时存在) 。  [0003] Diabetic foot is clinically divided into neuropathy type, arterial ischemia type, and mixed type (i.e., neuropathy and arterial ischemia simultaneously exist).
[0004] 糖尿病足的溃疡及坏疽的高危险因素有周围血管神经病变、 植物神经病变、 保护觉 丧失、 微血管病变、 代谢因素、 以往有足溃疡史、 足畸形、 有胼胝、 失明及视力严重减退、 合并肾脏病变、 老年人、 糖尿病认知力差等, 对于这些高危险因素的防治相当重要; 老年缺 血性糖尿病足的发生尤为多见, 主要是周围血管神经病变所致; 毛细血管基底膜增厚是由于 血管管腔狭窄, 内膜粗糙, 血管弹力和收縮力降低, 血流不畅, 致组织缺血缺氧, 红细胞变 形性差、 血液流变学异常, 血管内皮损伤等因素易引起毛细血管基底膜增厚, 并有透明样物 质沉积, 从而引起微血管病变压, 糖尿病患者由于血管病变, 引起神经营养障碍和缺血性神 经炎。  [0004] High risk factors for ulceration and gangrene in diabetic foot include peripheral vascular neuropathy, autonomic neuropathy, loss of protection, microvascular disease, metabolic factors, history of foot ulcers, foot deformity, convulsions, blindness, and severe vision loss. , combined with renal disease, the elderly, poor cognitive ability of diabetes, etc., is very important for the prevention and treatment of these high risk factors; the occurrence of senile ischemic diabetic foot is particularly common, mainly caused by peripheral vascular neuropathy; capillary basement membrane Thickening is due to stenosis of the lumen, rough intima, decreased blood vessel elasticity and contraction, poor blood flow, tissue ischemia and hypoxia, poor red blood cell deformability, abnormal blood rheology, vascular endothelial injury and other factors easily cause capillary The vascular basement membrane is thickened, and there is deposition of a transparent substance, which causes microvascular lesion pressure. Diabetic patients cause neurotrophic disorders and ischemic neuritis due to vascular lesions.
【0005】 糖尿病足属中医 "脱疽" 范畴, 祖国医学认为糖尿病足的核心病因是气虚阳衰寒 凝、 气虚不能帅血、 阳衰不能温煦、 寒凝则血液瘀滞不行、 久之则肢端坏死而成脱疽。  [0005] Diabetic foot is a Chinese medicine "dislocation" category, the motherland medicine believes that the core cause of diabetic foot is qi deficiency, yang deficiency, cold qi, qi deficiency, can not be handsome, yang can not be warm, cold stagnation, blood stagnant, long-term limb Necrosis is dislocated.
[0006] 目前, 用于治疗糖尿病足的药物主要有: 1、 改善微循环治疗, 主要有山莨菪碱、 前 列素 El、 中药制剂复方丹参注射液等; 2、.降低血液凝固性, 主要有潘生丁、 阿司匹林、 华 法林、 培达等; 3、 抗感染治疗, 主要应用广谱抗生素和甲硝唑等; 4、 改善神经病变药物, 如依帕斯他等。 上述药物只能辅助治疗糖尿病足, 不能治标, 且副作用大, 易引发其他并发 [0006] At present, the main drugs for treating diabetic foot are: 1. Improve microcirculation treatment, mainly including anisodamine, prostaglandin El, traditional Chinese medicine preparation compound Danshen injection, etc.; 2. Reduce blood coagulation, mainly Pan Shengding, aspirin, warfarin, Pei Da, etc.; 3, anti-infective treatment, mainly applied broad-spectrum antibiotics and metronidazole; 4, improve neuropathic drugs, such as epasita. The above drugs can only help treat diabetic foot, can not cure the symptoms, and have large side effects, which easily lead to other complications.
1 替换页 (细则第 26条) 说明书 1 Replacement page (Article 26) Instruction manual
症。 disease.
[0007] 中国专利文献 CN101757152A 公开了一种用于治疗缺血性糖尿病足的中药组合物, ώ人参、 水蛭、 土鳖虫、 乳香、 赤芍、 降香、 檀香、 全蝎、 蝉蜕、 蜈蚣、 冰片、 酸枣仁组 成, 具有益气活血、 化瘀通络的功效, ¾组合物商品名称为通心络胶囊, 用于冠心病心绞痛 属心气虚乏、 血瘀络阻证, 虽对缺血性糖尿病足有一定疗效, 但起效慢, 且对神经病变型和 混合型糖尿病足无效。  [0007] Chinese patent document CN101757152A discloses a traditional Chinese medicine composition for treating ischemic diabetic foot, ginseng, leeches, earthworms, frankincense, red peony, scent, sandalwood, scorpion, scorpion, scorpion, Borneol, jujube kernel composition, with the effect of replenishing qi and activating blood circulation, resolving phlegm and blood stasis, 3⁄4 composition of the product name is Tongxinluo Capsule, used for coronary heart disease, angina pectoris is a deficiency of heart and blood stasis, although it is ischemic Diabetic foot has a certain effect, but it has a slow onset and is ineffective for neuropathic and mixed diabetic foot.
发明内容 Summary of the invention
[0008] 本发明所要解决的技术问题是现有技术中用于治疗糖尿病足的中药组合物起效慢, 对神经病变型、 动脉缺血型、 混合型糖尿病足无效的问题, 提供一种起效快, 对神经病变 型、 动脉缺血型、 混合型糖尿病足都有疗效的中药组合物及其制备方法。  [0008] The technical problem to be solved by the present invention is that the traditional Chinese medicine composition for treating diabetic foot in the prior art has a slow onset of action, and provides a kind of effect on the problem of ineffectiveness of neuropathic type, arterial ischemic type, and mixed type diabetic foot. Fast, a traditional Chinese medicine composition effective for neuropathic, arterial ischemic, mixed diabetic foot and a preparation method thereof.
[0009] 本发明提供了一种用于治疗糖尿病足的中药组合物, 该组合物原料药的重量份为: 全蝎 1-30份, 密陀僧 1-30份, 蜈蚣 1-30份, 冰片 1-20份, 大蓟 1-20份, 穿山甲 1-20份, 蓖麻子 1-20份, 地榆 1-20份, 红花 1-20份。 [0009] The present invention provides a traditional Chinese medicine composition for treating diabetic foot, the weight of the raw material of the composition is: 1-30 parts of whole glutinous rice, 1-30 parts of medusa, 1-30 parts of medlar, 1-20 parts of borneol, 1-20 parts of eucalyptus, 1-20 parts of pangolin, 1-20 parts of castor, 1-20 parts of mantle, 1-20 parts of safflower.
[0010]优选的本发明中药组合物原料药的重量份为: 全蝎 2-20份, 密陀僧 2-20份, 蜈蚣 2- 20份, 冰片 2-10份, 大蓟 2-10份, 穿山甲 2-10份, 蓖麻子 2-10份, 地榆 2-10份, 红花 2- 10份。  [0010] The preferred parts of the drug substance of the traditional Chinese medicine composition of the present invention are: 2-20 parts of whole glutinous rice, 2-20 parts of medusa, 蜈蚣2- 20 parts, 2-10 parts of borneol, 2-10 parts of sorghum 2-10 parts of pangolin, 2-10 parts of castor, 2-10 parts of mantle, 2-10 parts of safflower.
[0011】 最佳的本发明中药组合物原料药的重量份为: 全蝎 1份, 密陀僧 1份, 蜈蚣 1份, 冰片 1份, 大蓟 1份, 穿山甲 1份, 蓖麻子 1份, 地榆 1份, 红花 1份。  [0011] The most preferred parts of the traditional Chinese medicine composition of the present invention are: 1 part, 1 part of medusa, 1 part of medlar, 1 part of borneol, 1 part of eucalyptus, 1 part of pangolin, 1 part of castor bean. , 1 part of the cellar, 1 part of safflower.
[0012】 本发明的中药组合物可制成丸剂、 片剂、 胶囊剂、 糖浆剂、 颗粒剂、 膏剂。  [0012] The traditional Chinese medicine composition of the present invention can be formulated into a pill, a tablet, a capsule, a syrup, a granule, and a paste.
[0013] 所述中药组合物制成膏剂时所选用的基质是蛤蟆油、 凡士林、 獾油中的一种或多 种。  [0013] The substrate selected for the preparation of the traditional Chinese medicine composition is one or more of eucalyptus oil, petrolatum, and eucalyptus oil.
[0014] 本发明中药组合物的制备方法, 包括如下步骤:  [0014] The preparation method of the traditional Chinese medicine composition of the present invention comprises the following steps:
包括如下步骤: Including the following steps:
a)称取特定重量份的各原料药待用; a) weighing a specific weight of each drug substance for use;
b)将全蝎、 密陀僧、 蜈蚣、 冰片、 大蓟、 穿山甲、 蓖麻子、 地榆、 红花分别粉碎, 研成粉 末; b) crushing the whole scorpion, medusa, scorpion, borneol, scorpion, pangolin, castor bean, mantle, safflower, and grinding into powder;
c ) 将上述粉末混合, 加入蛤蟆油、 凡士林、 獾油中的一种或多种, 搅拌均匀即得外用膏 剂。 c) Mix the above powders, add one or more of eucalyptus oil, petrolatum, and eucalyptus oil, and mix well to obtain a topical cream.
[0015] 本发明还涉及该中药组合物在制备治疗糖尿病足药物中的用途。  [0015] The present invention also relates to the use of the traditional Chinese medicine composition for the preparation of a medicament for treating diabetic foot.
[0016] 中医治疗糖尿病足的原则及方法主要有清热解毒、 祛腐生肌、 活血化瘀、 温经通  [0016] The principles and methods for treating diabetic foot in Chinese medicine mainly include detoxification, phlegm and stasis, promoting blood circulation and removing blood stasis, and warming
2 替换页 (细则第 26条) 说明书 2 Replacement page (Article 26) Instruction manual
络、 消肿止痛。  Collapse, swelling and pain relief.
全蝎性平, 味辛, 有毒, 归肝经, 具息风镇痉, 攻毒散结, 通络止痛之功效, 列为君药; 密 陀僧性平, 味辛咸, 有毒, 入足厥阴肝经, 具燥湿、 解毒、 收敛、 防腐功效; 蜈蚣性温, 味 辛咸, 有毒, 归肝脾肺经, 具息风镇痉、 攻毒散结、 通络止痛之功效; 与密陀僧相伍, 增强 清热解毒、 通络止痛之功效, 共为臣药。  It is full of sputum, taste, poisonous, liver, qi and stagnation, attacking and dispersing, the effect of Tongluo and pain relief, listed as Jun medicine; Mito is flat, tastes salty, poisonous, into the foot Quyin liver meridian, with dampness, detoxification, astringent, antiseptic effect; phlegm temperature, taste spicy, toxic, liver, spleen and lung, spleen and phlegm, phlegm and blood stasis, Tongluo analgesic effect; The combination of Mito, enhances the efficacy of clearing away heat and detoxifying, relieving collaterals and relieving pain.
[0017] 大蓟性凉, 味甘苦, 归心、 肝经, 具散瘀、 解毒、 消痈之功效; 穿山甲性微寒, 味 咸, 具活血散结, 消痈溃坚之功效; 蓖麻子性平, 味甘辛, 归大肠、 肺经, 具消肿拔毒、 泻 下通滞之功效; 地榆性寒, 味苦酸, 归肝、 肺、 肾、 大肠经, 具凉血止血、 清热解毒、 消肿 敛疮之功效; 红花性温, 味辛, 归心、 肝经, 具活血通径、 散瘀止痛之功效, 与大蓟、 穿山 甲、 蓖麻子、 地榆共为佐药, 发挥散瘀、 活血、 凉血、 消肿拔毒、 止痛作用; 冰片性凉、 味 辛苦, 归心、 肺经, 具通诸窍、 散郁火、 去翳明目、 消肿止痛之功效, 其香走窜, 深入腠 理, 渗透力强, 能促进药物有效成分的吸收, 长时间作用于患处达到透皮作用为使药。  [0017] 蓟 蓟 cool, sweet and bitter, heart, liver, with dilation, detoxification, eliminate phlegm; pangolin slightly cold, taste salty, with blood circulation, eliminate the effect of sputum; castor Ping, sweetine, to the large intestine, lung, with swelling and detoxification, diarrhea and stagnation; cellar cold, bitter acid, liver, lung, kidney, large intestine, with cooling blood to stop bleeding, detoxification The effect of reducing swelling and soreness; safflower is warm, fragrant, heart-to-heart, liver, has the effect of activating blood circulation, dispersing phlegm and relieving pain, and is adjunctive with Datun, Pangolin, Castor, and Mantle.瘀, blood circulation, cooling blood, swelling and detoxification, analgesic effect; borneol is cool, tastes hard, heart, lung, with the effect of phlegm窜, in-depth treatment, strong penetration, can promote the absorption of the active ingredients of the drug, and act on the affected area for a long time to achieve transdermal action.
[0018】 以上九味药配合应用, 共奏清热解毒、 祛腐生肌、 活血化瘀、 温经通络、 消肿止痛 之功效, 对神经病变型、 动脉缺血型、 混合型糖尿病足, 症见足部肌肉萎缩, 足畸形, 足部 皮肤感染化脓、 皲裂、 溃疡, 指端溃疡、 坏疽等均有效。 [0018] The above nine herbs are used together to play the role of clearing away heat and detoxifying, phlegm and stasis, promoting blood circulation and removing blood stasis, warming meridians and collaterals, reducing swelling and relieving pain. For neuropathy, arterial ischemia, mixed type diabetic foot, syndrome Muscle atrophy, foot deformity, foot skin infections, purulent, cleft palate, ulcers, finger ulcers, gangrene, etc. are effective.
[0019] 本发明具有下述优点: [0019] The present invention has the following advantages:
本发明根据传统中医理论选用选用全蝎、 密陀僧、 蜈蚣、 冰片、 大蓟、 穿山甲、 蓖麻子、 地 榆、 红花为原料, 原料易得且成本低, 通过各味药材协同发挥清热解毒、 祛腐生肌、 活血化 瘀、 温经通络、 消肿止痛的作用, 用于治疗神经病变型、 动脉缺血型、 混合型糖尿病足, 症 见足部肌肉萎缩, 足畸形, 足部皮肤感染化脓、 皲裂、 溃疡, 指端溃疡、 坏疽, 标本兼治, 且无毒副作用, 患者使用后不易复发, 避免了西药治疗糖尿病足产生的副作用和截肢带来的 巨大痛苦。 According to the traditional Chinese medicine theory, the invention selects whole glutinous rice, medusa, medlar, borneol, medlar, pangolin, castor bean, mantle, safflower as raw materials, the raw materials are easy to obtain and the cost is low, and the heat and detoxification are synergistically exerted through various medicinal materials. , phlegm and stasis, promoting blood circulation and removing blood stasis, warming meridians and collaterals, reducing swelling and relieving pain, for treating neuropathic type, arterial ischemic type, mixed type diabetic foot, syndrome of foot muscle atrophy, foot deformity, foot skin infection and suppuration, Cleft palate, ulcer, finger ulcer, gangrene, both symptoms and symptoms, and no toxic side effects, patients are not easy to relapse after use, to avoid the side effects caused by Western medicine treatment of diabetic foot and the great pain caused by amputation.
具体实施方式 detailed description
[0020] 实施例 1 Embodiment 1
称取密陀僧 30g, 蜈蚣 30g, 冰片 20g, 大蓟 20g, 穿山甲 20g, 蓖麻子 20g, 地榆 20g, 红 花 20g, 分别粉碎, 研成粉末; 将上述粉末混合, 加入蛤蟆油 60g, 搅拌均匀即得外用膏 剂。 Weighed 30g, 蜈蚣30g, borneol 20g, glutinous rice 20g, pangolin 20g, castor bean 20g, mantle 20g, safflower 20g, crushed separately, ground into powder; mix the above powder, add 60g of oyster sauce, stir Evenly, it can be used as a topical cream.
[0021] 实施例 2  Embodiment 2
称取密陀僧 20g, 蜈蚣 20g, 冰片 15g, 大蓟 15g, 穿山甲 15g, 蓖麻子 15g, 地榆 15g, 红 花 15g, 分别粉碎, 研成粉末; 将上述粉末混合, 加入凡士林油 45g, 搅拌均勾即得外用膏 Weigh 20g of medusa, 蜈蚣20g, borneol 15g, eucalyptus 15g, pangolin 15g, castor bean 15g, mantle 15g, safflower 15g, crushed separately, ground into powder; mix the above powder, add Vaseline oil 45g, stir External cream
3 替换页 (细则第 26条) 说明书 3 Replacement page (Article 26) Instruction manual
剂。 Agent.
[0022] 实施例 3  Embodiment 3
称取密陀僧 10g, 蜈蚣 10g, 冰片 10g, 大蓟 10g, 穿山甲 10g, 蓖麻子 10g, 地榆 10g, 红 花 10g, 分别粉碎, 研成粉末; 将上述粉末混合, 加入獾油 30g, 搅拌均匀即得外用膏剂。 Weigh 10g, 10g, borneol 10g, eucalyptus 10g, pangolin 10g, castor bean 10g, mantle 10g, safflower 10g, crushed separately, ground into powder; mix the above powder, add 30g of oyster sauce, stir Evenly, it can be used as a topical cream.
[0023] 实施例 4 Embodiment 4
称取密陀僧 10g, 蜈蚣 10g, 冰片 8g, 大蓟 8g, 穿山甲 8g, 蓖麻子 8g, 地榆 8g, 红花 8g, 分别粉碎, 研成粉末; 将上述粉末混合, 装入胶囊, 即制得胶囊剂。 Weigh 10g, 10g, borneol 8g, eucalyptus 8g, pangolin 8g, castor bean 8g, mantle 8g, safflower 8g, crushed separately, ground into powder; mix the above powder, capsule, ready Get capsules.
[0024] 实施例 5 [0024] Example 5
称取密陀僧 25g, 蜈蚣 25g, 冰片 20g, 大蓟 20g, 穿山甲 20g, 蓖麻子 20g, 地榆 20g, 红 花 20g, 分别粉碎, 研成粉末; 将上述粉末混合, 加入獾油 30g和蛤蟆油 30g, 搅拌均匀即 得外用膏剂。 Weighed 25g, 25g, borneol 20g, glutinous rice 20g, pangolin 20g, castor bean 20g, mantle 20g, safflower 20g, crushed separately, ground into powder; mix the above powder, add oyster sauce 30g and 蛤蟆30 g of oil, stir well to obtain a topical paste.
[0025] 实施例 6 [0025] Example 6
称取密陀僧 20g, 蜈蚣 20g, 冰片 15g, 大蓟 15g, 穿山甲 15g, 蓖麻子 15g, 地榆 15g, 红 花 15g, 分别粉碎, 研成粉末; 将上述粉末混合, 加入蛤蟆油 20g和凡士林 20g, 搅拌均匀 即得外用膏剂。 Weigh 20g of medusa, 蜈蚣20g, borneol 15g, eucalyptus 15g, pangolin 15g, castor bean 15g, mantle 15g, safflower 15g, crushed separately, ground into powder; mix the above powder, add oyster sauce 20g and vaseline 20g, stir evenly to get a topical cream.
[0026] 实施例 7 Example 7
称取密陀僧 15g, 蜈蚣 15g, 冰片 15g, 大蓟 15g, 穿山甲 15g, 蓖麻子 15g, 地榆 15g, 红 花 15g, 分别粉碎, 研成粉末; 将上述粉末混合, 加入凡士林 20g、 蛤蟆油 10g 和獾油 10g, 搅拌均匀即得外用膏剂。 Weigh 15g, 15g, borneol 15g, eucalyptus 15g, pangolin 15g, castor bean 15g, mantle 15g, safflower 15g, crushed separately, ground into powder; mix the above powder, add Vaseline 20g, oyster sauce 10g and oyster sauce 10g, stir well to obtain a topical paste.
[0027] 实验例 [0027] Experimental example
为了表明该中药组合物对神经病变型、 动脉缺血型、 混合型糖尿病足的治疗效果, 本发明经 100例系统临床观察, 并记录其病史、 病情、 年龄及原始治疗方法进行对比疗效实验。 In order to show the therapeutic effect of the traditional Chinese medicine composition on the neuropathic type, arterial ischemic type, mixed type diabetic foot, the present invention was systematically observed in 100 cases, and the medical history, the condition, the age and the original treatment method were recorded for comparative efficacy experiments.
[0028] 该 100例患者中患有神经病变型糖尿病足 30人、 动脉缺血型糖尿病足 40人、 混合 型糖尿病足 30人。 在上述患者中, 大多数表现为足部肌肉萎缩, 足畸形, 足部皮肤感染化 脓、 皲裂、 溃疡, 指端溃疡、 坏疽。 [0028] Among the 100 patients, there were 30 patients with neuropathic diabetic foot, 40 patients with arterial ischemic diabetes, and 30 patients with mixed diabetes. In the above-mentioned patients, most of the manifestations are foot muscle atrophy, foot deformity, foot skin infection, purulent, cleft palate, ulcer, fingertip ulcer, gangrene.
[0029] 临床治疗效果的判断标准为: [0029] The criteria for judging clinical treatment effects are:
临床治愈: 原有症状消失。 Clinical cure: The original symptoms disappear.
[0030] 显效: 原有症状部分消失。 [0030] Significant effect: The original symptoms partially disappeared.
[0031] 好转: 原有病情有所减轻。 [0031] Improvement: The original condition has been alleviated.
[0032] 无效: 症状体征无变化。 [0032] Invalid: There is no change in symptoms and signs.
4 替换页 (细则第 26条) 说明书 4 Replacement page (Article 26) Instruction manual
【0033】 给药方法为: 给患者患部贴敷实施例 3制备的膏剂。  [0033] The administration method is as follows: The ointment prepared in Example 3 is applied to the affected part of the patient.
[0034] 疗程: 十五天为一疗程, 每天使用一次。  [0034] Treatment: 15 days for a course of treatment, once a day.
[0035] 临床实验结果表明, 仅使用一疗程该中药组合物, 原有症状明 减轻。 据统计, 5% 症状较轻患者, 可一次治愈, 使用一疗程后, 达到 95%的治愈率, 5%V.效或好转, 无无效 情况 (见表 1 ) 。  [0035] The results of clinical trials show that the original symptoms are alleviated by using only one course of the traditional Chinese medicine composition. According to statistics, 5% of patients with mild symptoms can be cured at one time. After one course of treatment, the cure rate is 95%, 5% V. Efficacy or improvement, no invalidity (see Table 1).
Figure imgf000006_0001
Figure imgf000006_0001
[0036] 在上述临床实验中, 对患者用药前后的血尿常规、 肝肾功能、 心电图等做了检査并 记录, 对比未发现异常, 可见该中药组合物无毒副作用, 两年后对上述病例进行回访, 无复 发患者。 [0036] In the above clinical experiment, the hematuria routine, liver and kidney function, electrocardiogram, etc. before and after the patient's medication were examined and recorded, and no abnormalities were found in the comparison, and the Chinese medicine composition was found to have no toxic and side effects, and the case was obtained two years later. A return visit was made to patients without recurrence.
[0037] 对比实验例  Comparative Experimental Example
称取 39.6g人参、 72.6g水蛭、 46.2g土鳖虫、 13.2g乳香 (制) 、 33g赤芍、 13.2g 降香、 13.2g檀香、 19.8g全蝎、 46.2g蝉蜕、 6.6g蜈蚣、 33g冰片、 33g酸枣仁 (炒) , 按照前述中 国专利文献 CN101757152A公开的方法制成胶囊。 使用该胶囊对相同体质、 病情状态的 100 例患者进行临床试用, 给药方法为一次 4粒, 一日 3次。 Weigh 39.6g ginseng, 72.6g leeches, 46.2g soil mites, 13.2g frankincense, 33g red peony, 13.2g scent, 13.2g sandalwood, 19.8g radix, 46.2g 蝉蜕, 6.6g 蜈蚣, 33g Borneol, 33 g of jujube kernel (fried), was made into a capsule according to the method disclosed in the aforementioned Chinese patent document CN101757152A. The capsule was used for clinical trials in 100 patients of the same constitution and condition, and the administration method was 4 capsules at a time, 3 times a day.
[0038] 连续服用 15天后, 结果如表 2所示, 其平均治愈率只能达到 30%, 且仅对动脉缺血 型糖尿病足疗效较好。  [0038] After 15 days of continuous administration, the results are shown in Table 2. The average cure rate was only 30%, and only the arterial ischemic diabetic foot was better.
Figure imgf000006_0002
Figure imgf000006_0002
5 替换页 (细则第 26条) 说明书 5 Replacement page (Article 26) Instruction manual
[0039] 虽然本发明已经通过上述具体实施例对其进行了详细阐述, 但是, 本专业普通技术 人员应该明白, 在此基础上所做出的未超出权利要求保护范围的任何形式和细节的变化, 均 属于本发明所要保护的范围。  [0039] While the invention has been described in detail hereinabove by the foregoing specific embodiments, those of ordinary skill in the art All belong to the scope of the invention to be protected.
6 6
替换页 (细则第 26条)  Replacement page (Article 26)

Claims

权 利 要 求 书 Claim
1. 一种中药组合物, 其特征在于: 该组合物原料药的重量份为: 全蝎 1-30份, 密陀僧 1-30 份, 蜈蚣 1-30份, 冰片 1-20份, 大蓟 1-20份, 穿山甲 1-20份, 蓖麻子 1-20份, 地榆 1-20 份, 红花 1-20份。  A traditional Chinese medicine composition, characterized in that the weight of the raw material of the composition is: 1-30 parts of whole glutinous rice, 1-30 parts of medusa, 1-30 parts of medlar, 1-20 parts of borneol, large蓟 1-20 parts, 1-20 parts of pangolin, 1-20 parts of castor, 1-20 parts of mantle, 1-20 parts of safflower.
2. 根据权利要求 1 所述的中药组合物, 其特征在于: 所述原料药的重量份为: 全蝎 2-20 份, 密陀僧 2-20份, 蜈蚣 2-20份, 冰片 2-10份, 大蓟 2-10份, 穿山甲 2-10份, 蓖麻子 2- 10份, 地榆 2-10份, 红花 2-10份。  2. The traditional Chinese medicine composition according to claim 1, wherein the weight of the raw material drug is: 2-20 parts of whole mash, 2-20 parts of medhong, 2-20 parts of 蜈蚣, borneol 2 10 parts, 2-10 parts of sorghum, 2-10 parts of pangolin, 2-10 parts of castor, 2-10 parts of mantle, 2-10 parts of safflower.
3. 根据权利要求 2所述的中药组合物, 其特征在于: 所述原料药的重量份为: 全蝎 1 份, 密陀僧 1份, 蜈蚣 1份, 冰片 1份, 大蓟 1份, 穿山甲 1份, 蓖麻子 1份, 地榆 1份, 红花 1份。  The traditional Chinese medicine composition according to claim 2, wherein the weight of the raw material drug is: 1 part, 1 part of medusa, 1 part of mash, 1 part of borneol, 1 part of sorghum, 1 part of pangolin, 1 part of castor, 1 part of mantle, 1 part of safflower.
4. 根据权利要求 1 至 3 任一所述的中药组合物, 其特征在于: 所述中药组合物可制成丸 剂、 片剂、 胶囊剂、 糖浆剂、 颗粒剂、 膏剂。  The traditional Chinese medicine composition according to any one of claims 1 to 3, wherein the traditional Chinese medicine composition is formulated into a pellet, a tablet, a capsule, a syrup, a granule, and a paste.
5. 根据权利要求 4 所述的中药组合物, 其特征在于: 所述中药组合物制成膏剂时所选用的 基质是蛤蟆油、 凡士林、 獾油中的一种或多种。  The traditional Chinese medicine composition according to claim 4, wherein the substrate selected for the preparation of the traditional Chinese medicine composition is one or more of eucalyptus oil, petrolatum, and eucalyptus oil.
6. 权利要求 5所述的中药组合物的制备方法, 包括如下步骤:  6. The method for preparing a traditional Chinese medicine composition according to claim 5, comprising the steps of:
a) 称取特定重量份的各原料药待用; a) weighing a specific weight of each drug substance for use;
b ) 将全蝎、 密陀僧、 蜈蚣、 冰片、 大蓟、 穿山甲、 蓖麻子、 地榆、 红花分别粉碎, 研成粉 末; b) crushing the whole scorpion, medusa, scorpion, borneol, scorpion, pangolin, castor bean, mantle, and safflower, and grinding into powder;
c ) 将上述粉末混合, 加入蛤蟆油、 凡士林、 獾油中的一种或多种, 搅拌均匀即得外用膏 剂。 c) Mix the above powders, add one or more of eucalyptus oil, petrolatum, and eucalyptus oil, and mix well to obtain a topical cream.
7. 权利要求 1至 3任一所述中药组合物在制备治疗糖尿病足药物中的用途。  7. Use of a traditional Chinese medicine composition according to any one of claims 1 to 3 for the preparation of a medicament for treating diabetic foot.
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