CN103893458A - Traditional Chinese medicine composition for external use for treating diabetic foot ulcer, preparation method and application of traditional Chinese medicine composition - Google Patents
Traditional Chinese medicine composition for external use for treating diabetic foot ulcer, preparation method and application of traditional Chinese medicine composition Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for external use for treating diabetic foot ulcer. The traditional Chinese medicine composition is prepared from the raw materials in parts by weight: coptis chinensis, pseudo-ginseng, lithospermum, salvia miltiorrhiza, golden cypress, frankincense, myrrh, dragon blood, beewax and calcined gypsum, wherein the raw materials have synergistic effects for recovering the elasticity for the blood vessels by clearing away heat and toxic materials and promoting blood circulation to remove blood stasis; the insufficient blood supply can trend to be normal in a slow process; gene regulation elements and effective active molecules in the traditional Chinese medicine raw materials can enter diseased parts of the blood; in a smooth and steady regulating process, the traditional Chinese medicine composition for external use can be used for repairing damaged tissues and organs of the body by improving liver and kidney mainly, controlling the diabetic pathogenesis step by step, regulating the human body nervous system and promoting blood circulation, playing a coordination and comprehensive treatment role, changing the diabetic pathogenesis radically and recovering the body; the traditional Chinese medicine composition for external use has the effects of removing slough and promoting growth of tissue regeneration, warming the meridians, tonifying qi and activating blood, alleviating phishom limb pain, controlling ulcer surface infection, improving local microcirculation, enhancing bidirectional transfer function of endothelial cells, improving conduction velocity of peripheral nerve and promoting the repair of the tissues and the healing of the wound surfaces.
Description
Technical field
The present invention relates to a kind of medicine for the treatment of diabetes, particularly a kind of diabetic foot ulcer external medicine composition, preparation method and application thereof.
Background technology
Diabetic foot is a kind of common diabetic complication, and it has a strong impact on patient's work capacity and quality of life.Diabetic foot ulcer is the main clinical manifestation of diabetic foot, and its amputation rate is 15-20 times of ND, and the relevant full cause death rate of research prompting diabetics amputation relatively raises more than 5 times compared with ND.The existing diabetics of China approximately 9,000 2 hundred ten thousand, diabetic foot sickness rate is about 0.9%-14.5%.Diabetic foot has brought heavy burden to social medical resource.In western countries, the cost of diabetic foot ulcer is 16000-27000 dollar/routine patient, and the medical treatment of amputation spends up to 43000-64000 dollar/routine patient.In developing country, diabetic foot has expended approximately 40% health resources, and China there is no official's data, on average calculates according to my section's diabetic foot inpatient, and every routine patient with diabetic feet mean treatment expense is about 6-8 ten thousand RMB.But the clinical treatment of diabetic foot but lacks effective measures always.Comprehensive recent domestic document mainly contains following Therapeutic Method to diabetic foot:
(1) control blood glucose: the same with other complication for the treatment of, first treatment diabetic foot ulcer must control hyperglycemia.The pathologic basis of diabetic foot ulcer is microangiopathies, control hyperglycemia and can improve microcirculation, reducing body fluid and albumen oozes out, make a large amount of leukocyte enter the anti-infection ability that strengthens local organization between tissue, alleviate peripheral neuropathy, increase neurotrophy and supply with, be conducive to infect and gangrenous wound healing.Therefore controlling hyperglycemia is the prerequisite for the treatment of primary disease.In the time that acromelic gangrene appears in diabetes, must use insulin control blood glucose instead.
(2) improve blood circulation: as little arteriovenous of the expansible whole body of medicine such as 654-2, ligustrazine, Folium Ginkgo extract, PGE1, urokinases, increase microcirculation blood volume around, reduce resistance of blood flow, improve microcirculation.
(3) infection: infection comprises systemic infection and local infection, should select effective antibiotics infection control, and the quality of infection control directly affects blood glucose and ulcer of foot healing.
(4) surgical operation and interventional therapy: the equipment needed thereby such as arterial bracket, balloon expandable, artery plaque melt, artery plaque rotary-cut art, artificial blood vessel bridging is accurate expensive, wound weighs, has a big risk, expense is high, complication is many, mortality rate is high, patient dependence is poor.
(5) stem-cell therapy: equipment needed thereby is accurate expensive, is subject to ethics restriction, and most hospitals can not carry out, and late result has to be seen.
(6) decompression limb tool: mainly comprise full contact Gypsum Fibrosum, the detachable brace of walking.The generation of diabetic foot ulcer and local pressure abnormal distribution are closely related, the mechanism of action of decompression limb tool be pressure transfer that wound surface is born to normal structure, thereby play the effect of protecting wound surface.Full contact Gypsum Fibrosum needs experienced doctor's operation, therefore affects to a certain extent its clinical expansion.Its shortcoming is to make troubles to patient, to the patient's forbidding with traumatic infection and myelitic diabetic foot.Detachable walking brace has overcome the shortcoming of full contact Gypsum Fibrosum, makes more complicated, higher to operation doctor requirement.
(7) biological dressing: along with the development of biotechnology, traditional dressing is updated, occurred now a lot of novel dressing as: semi-permeable poly film dressing has the effect that absorbs the harmful transudate of wound surface; Promogran is a kind of dressing that contains collagen and oxidized regenerated cellulose, can be by reducing the microenvironment of digestive enzyme (neutrophilic granulocyte enzyme, fibrinolysin, matrix metalloproteinase) the change wound surface in wound exudate; Alginate dressing is a kind of absorbable gel dressing, has the effect of activation of chronic wound surface macrophage; Negative pressure therapeutic devices will form negative pressure between wound surface and dressing, and it is divided into continuous negative pressure treatment and negative pressure treatment at intermittence, and negative pressure treatment can be eliminated chronic edema, reduces the afterload of little blood vessel, increases regional blood flow, promotes the formation of granulation tissue.Every kind of dressing all has a kind of theoretical support in a word, but often mostly lacks effective clinical evidence, but that its shortcoming is less stable and absorbs sepage is indifferent.
(8) local cells is transplanted: it is that fibroblasts of adult human dermis is planted in biological support and cultivated that human dermis's cell culture is transplanted, and can form the growth of corium sub support matrix chrotoplast after 2 weeks.Its advantage is to discharge the somatomedin relevant with wound healing, cytokine, protease, platelet liberin, CT-102, CT-102 can discharge multiple somatomedin and comprise: PDGF-BB, epidermal growth factor, transforming growth factor-beta, fibroblast growth factor, these somatomedin can promote granulation tissue to form and epithelization, accelerate ulcer healing.FDA Food and Drug Administration has allowed PDGF-BB to be used for the treatment of diabetic foot wound surface at present.PDGF-BB expensive price.Epidermal growth factor is the fibroblast mitogen of dose dependent.
(9) granulocyte colony-stimulating factor (Granulocyte-colony stimulating factor, GCSF) be mainly used in the patient of diabetic foot traumatic infection, it can regulate propagation, differentiation, the maturation of neutrophilic granulocyte and be released into Peripheral Circulation, its shortcoming is to cause high blood coagulation state, brings out myocardial infarction, thrombosis.
(10) local debridement: diabetic foot ulcer is that diabetes systemic disease is in a local performance the most serious, now partial cut drain, debridement are changed dressings extremely important, the debridement of the debridement of diabetic foot and surgery Other diseases has important difference, surgery adopts " ingurgitation formula debridement " more, and the debridement of diabetic foot is just in time contrary, many employings " nibbling formula debridement ".
(11) external application Chinese medicine unguentum: although diabetic foot method is more, but most of armarium costlinesses, medical expense is high, uncertain therapeutic efficacy is cut, have a big risk, complication is many,, reasonable price safe and effective in clinical middle searching, the Therapeutic Method that risk is low, complication is few are perplexing clinician always.Treatment by Chinese herbs is China's traditional medicine, it has highlighted some superiority in diabetic foot ulcer treatment, but the domestic literature report Diabetes Mellitus Treated With Traditional Chinese Medicine ulcer of foot overwhelming majority is clinical observation, its mechanism of action is still quoted original theory of Chinese medical science as heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, putrefaction-removing granulation-promoting, reducing swelling and alleviating pain etc.
According to the evaluation of " international diabetic foot cooperation tissue ", in the Therapeutic Method of diabetic foot ulcer, have only have hyperbaric oxygen and the closed negative pressure of clear and definite evidence-based medical to attract treatment, and other therapies comprise that various local external application medicine things there is no evidence-based medical support.Chinese medicine is used to treat skin trauma always and comprises diabetic foot ulcer, and its mechanism is heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling and promotion wound healing.But it follows card lack of evidence about the curative effect of these therapies, not yet obtain admitting of international and domestic doctor trained in Western medicine circle.Reason is: (1) TCM Treatment of Diabetes ulcer of foot clinical research of low quality, and the repeatability of its curative effect is poor, thereby credibility is under suspicion; (2), compared with doctor trained in Western medicine, the traditional Chinese medical science is indefinite with the advantage of doctor trained in Western medicine comparison aspect thoroughly evaluating curative effect especially objective indicator; (3) effect of therapy of combining Chinese and Western medicine there is no strict Clinical Evidence.
Although the existing Chinese medicine for the outer application of diabetic foot has certain curative effect, onset is slow, and the course for the treatment of is long, and safety and health giving quality are poorer.
Summary of the invention
In view of this, the object of the present invention is to provide a kind of diabetic foot ulcer external medicine composition, preparation method and application thereof, this Chinese medicine composition has evident in efficacy, rapid-action, and short treating period is safe, good effect.
Diabetic foot ulcer external medicine composition of the present invention, Chinese medicine composition raw material comprises following component by weight: 15～28 parts of Rhizoma Coptidis parts, 5～18 parts of Radix Notoginseng, 15～28 parts of Radix Arnebiae (Radix Lithospermi)s, 3～16 parts of Radix Salviae Miltiorrhizaes, 7～22 parts of Cortex Phellodendris, 1～10 part of Olibanum, 1～10 part of Myrrha, 1～10 part of Sanguis Draxonis, 1～10 part, Cera Flava, 15～32 parts of Gypsum Fibrosum Preparatum;
Further, Chinese medicine composition raw material comprises following component by weight: 15～22 parts of Rhizoma Coptidis parts, 7～15 parts of Radix Notoginseng, 15～22 parts of Radix Arnebiae (Radix Lithospermi)s, 6～12 parts of Radix Salviae Miltiorrhizaes, 7～15 parts of Cortex Phellodendris, 3～10 parts of Olibanums, 3～10 parts of Myrrhas, 3～10 parts of Sanguis Draxonis, 3～10 parts, Cera Flava, 15～22 parts of Gypsum Fibrosum Preparatum;
Further, Chinese medicine composition raw material comprises following component by weight: 18 parts of Rhizoma Coptidis parts, 9 parts of Radix Notoginseng, 18 parts of Radix Arnebiae (Radix Lithospermi)s, 9 parts of Radix Salviae Miltiorrhizaes, 12 parts of Cortex Phellodendris, 6 parts of Olibanums, 6 parts of Myrrhas, 6 parts of Sanguis Draxonis, 6 parts, Cera Flava, 18 parts of Gypsum Fibrosum Preparatum;
Further, when this Chinese medicine composition uses, can add one or more for improving or treat the Chinese medicine of accompanied symptoms;
Further, the preparation that the pharmaceutical carrier that this Chinese medicine can add medical science to accept is made;
Further, described Chinese medicine composition is unguentum.
The present invention also discloses a kind of preparation method of diabetic foot ulcer external medicine composition, comprises the following steps:
By setting weight part, Rhizoma Coptidis, Radix Notoginseng, Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae, Cortex Phellodendri, Olibanum, Myrrha are added in Oleum Sesami and soak rear decoction to slightly bitter, after impurity screening, continue to decoct to Oleum Sesami and boil, then adding successively the Sanguis Draxonis of setting weight part and Cera Flava to be stirred to it melts completely, after finally adding the Gypsum Fibrosum Preparatum of setting weight part, stir, obtain diabetic foot ulcer external medicine composition;
Further, by setting weight part, Rhizoma Coptidis, Radix Notoginseng, Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae, Cortex Phellodendri, Olibanum, Myrrha are added and in Oleum Sesami, soak 3-8 days;
Further, in Oleum Sesami, soak 6 days.
The present invention also discloses a kind of diabetic foot ulcer external medicine composition, the application of this Chinese medicine composition in the medicine of preparing diabetic foot ulcer.
Beneficial effect of the present invention: diabetic foot ulcer external medicine composition of the present invention, preparation method and application thereof, Sanguis Draxonis is that property is sweet salty flat, has the function of promoting blood circulation to remove blood stasis pain relieving, convergence granulation promoting, has antifungal effect.Olibanum, Myrrha, resinous, volatile oil, has good blood circulation promoting and blood stasis dispelling, Repercusion analgesia, promoting pus discharge and tissue regeneration strengthening effect.
Gypsum Fibrosum Preparatum, property is sweet, pungent, puckery, cold, has effect of removing dampness granulation promoting, sore hemostasis, energy anti-bacteria, especially, to staphylococcus aureus, bacillus pyocyaneus sensitivity, Gypsum Fibrosum also has heat clearing away, analgesic activity, tip blood capillary is had to dilating effect, can promote local blood circulation.
Radix Notoginseng is warm in nature, sweet in the mouth, micro-hardship.Function cures mainly: hemostasis, dissipating blood stasis, detumescence, pain relieving." jade is seized medicine solution ": and battalion hemostasis, the clots absorbing of promoting blood circulation, clots absorbing blood and hold back fresh blood.Modern study, can promote hemopoietic, promoting tissue regeneration by removing blood stasis.
Rhizoma Coptidis, heat-clearing and toxic substances removing, blood sugar lowering, antibacterial.
Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling, removing heat from blood eliminating carbuncle, tissue regeneration promoting blood, removes stagnant blood.
Cortex Phellodendri hardship, cold.Function cures mainly: heat clearing and damp drying, eliminating fire and detoxication, except hectic fever due to YIN-deficiency clearind deficient heat.For damp-heat dysentery, jaundice, sore swollen toxin, eczema pruritus ...Modern study, Cortex Phellodendri has antiinflammatory, suppressing the hyperactive liver.
Cera Flava, removing toxic substances; Granulation promoting; Hemostasis; Analgesic therapy.Main carbuncle carbuncle on the back, ulcer is for holding back.
Synergism between said components material, pass through heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, make the blood vessel of whole body recover elasticity, by original blood supply insufficiency to being tending towards normal slowly process, Gene regulation element and effective active molecule in raw material of Chinese medicine enter blood, through diseased region, in steady adjustment process, taking nourishing liver and kidney as main, repair the impaired histoorgan of human body, progressively control the pathogenesis of diabetes, mediator's somatic nervous system, blood circulation promoting, play and coordinate and Comprehensive Treatment function, fundamentally thorough reverting diabetes pathogenesis, make health reach rehabilitation, putrefaction-removing granulation-promoting, promoting the flow of QI-blood by warming the meridian, benefiting QI for activating blood circulation) alleviate limb pain, control skin ulcer face and infect, improve local microcirculation, strengthen the two-way transhipment function of endotheliocyte, improve perineural conduction velocity, promote the healing of tissue repair and wound surface.
Can also interiorly adjust internal organs simultaneously, repair fast patient's neural blood vessel pathological changes, promote local edema to eliminate, the blood fortune of improving effectively lower limb is unimpeded, slow down suffering limb numbness that patient with diabetic feet causes because blood-vessels what hinders, have an intense pain, can effectively promote the fester quickly-healing of wound surface of diabetic foot lower limb; Treatment time: the 15 basic alleviating pains in sky, left and right, numbness; Wound healing, incrustation about 2 months.
Brief description of the drawings
Fig. 1 is the diabetic foot symptom figure before treatment;
Fig. 2 is the design sketch for the treatment of after 8 weeks.
Detailed description of the invention
Diabetic foot ulcer external medicine composition of the present invention, Chinese medicine composition raw material comprises following component by weight: 15～28 parts of Rhizoma Coptidis parts, 5～18 parts of Radix Notoginseng, 15～28 parts of Radix Arnebiae (Radix Lithospermi)s, 3～16 parts of Radix Salviae Miltiorrhizaes, 7～22 parts of Cortex Phellodendris, 1～10 part of Olibanum, 1～10 part of Myrrha, 1～10 part of Sanguis Draxonis, 1～10 part, Cera Flava, 15～32 parts of Gypsum Fibrosum Preparatum.
In the present embodiment, Chinese medicine composition raw material comprises following component by weight: 15～22 parts of Rhizoma Coptidis parts, 7～15 parts of Radix Notoginseng, 15～22 parts of Radix Arnebiae (Radix Lithospermi)s, 6～12 parts of Radix Salviae Miltiorrhizaes, 7～15 parts of Cortex Phellodendris, 3～10 parts of Olibanums, 3～10 parts of Myrrhas, 3～10 parts of Sanguis Draxonis, 3～10 parts, Cera Flava, 15～22 parts of Gypsum Fibrosum Preparatum.
In the present embodiment, Chinese medicine composition raw material comprises following component by weight: 18 parts of Rhizoma Coptidis parts, 9 parts of Radix Notoginseng, 18 parts of Radix Arnebiae (Radix Lithospermi)s, 9 parts of Radix Salviae Miltiorrhizaes, 12 parts of Cortex Phellodendris, 6 parts of Olibanums, 6 parts of Myrrhas, 6 parts of Sanguis Draxonis, 6 parts, Cera Flava, 18 parts of Gypsum Fibrosum Preparatum.
In the present embodiment, this Chinese medicine composition can add one or more for improving or treat the Chinese medicine of accompanied symptoms while use.
In the present embodiment, the preparation that the pharmaceutical carrier that this Chinese medicine can add medical science to accept is made; Can make powder, unguentum, water preparation etc. are for washing or external application
In the present embodiment, be preferably into unguentum and as external application and use.
The present invention also discloses a kind of preparation method of diabetic foot ulcer external medicine composition, comprises the following steps:
By setting weight part, Rhizoma Coptidis, Radix Notoginseng, Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae, Cortex Phellodendri, Olibanum, Myrrha are added in Oleum Sesami and soak rear decoction to slightly bitter, after impurity screening, continue to decoct to Oleum Sesami and boil, then adding successively the Sanguis Draxonis of setting weight part and Cera Flava to be stirred to it melts completely, after finally adding the Gypsum Fibrosum Preparatum of setting weight part, stir, obtain diabetic foot ulcer external medicine composition.
In the present embodiment, by setting weight part, Rhizoma Coptidis, Radix Notoginseng, Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae, Cortex Phellodendri, Olibanum, Myrrha are added and in Oleum Sesami, soak 3-8 days.
In the present embodiment, be preferably and in Oleum Sesami, soak 6 days.
Diabetic foot ulcer external medicine composition of the present invention, the application of this Chinese medicine composition in the medicine of preparing diabetic foot ulcer.
Below by specific embodiment, Chinese medicine composition of the present invention is further elaborated:
Embodiment mono-
The diabetic foot ulcer external medicine composition of the present embodiment, Chinese medicine composition raw material comprises following component by weight: 18 parts of Rhizoma Coptidis parts, 9 parts of Radix Notoginseng, 18 parts of Radix Arnebiae (Radix Lithospermi)s, 9 parts of Radix Salviae Miltiorrhizaes, 12 parts of Cortex Phellodendris, 6 parts of Olibanums, 6 parts of Myrrhas, 6 parts of Sanguis Draxonis, 6 parts, Cera Flava, 18 parts of Gypsum Fibrosum Preparatum.
Rhizoma Coptidis, Radix Notoginseng, Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae, Cortex Phellodendri, Olibanum, Myrrha are soaked 6 days in proportion in Oleum Sesami; Then, endure to slightly bitter with slow fire, wherein undissolved contaminant filter after falling boils Oleum Sesami, successively puts into Sanguis Draxonis and Cera Flava and does not stop to be stirred to it and melt completely; Finally, add Gypsum Fibrosum Preparatum, leave standstill and micro-ly do not stop to be stirred to into even paste after cool, with sterile vessel subpackage and to be placed in cleaning ambient for subsequent use.
Embodiment bis-
The diabetic foot ulcer external medicine composition of the present embodiment, Chinese medicine composition raw material comprises following component by weight: 15 parts of Rhizoma Coptidis parts, 5 parts of Radix Notoginseng, 15 parts of Radix Arnebiae (Radix Lithospermi)s, 3 parts of Radix Salviae Miltiorrhizaes, 7 parts of Cortex Phellodendris, 1 part of Olibanum, 1 part of Myrrha, 1 part of Sanguis Draxonis, 1 part, Cera Flava, 15 parts of Gypsum Fibrosum Preparatum.
Rhizoma Coptidis, Radix Notoginseng, Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae, Cortex Phellodendri, Olibanum, Myrrha are soaked 3 days in proportion in Oleum Sesami; Then, endure to slightly bitter with slow fire, wherein undissolved contaminant filter after falling boils Oleum Sesami, successively puts into Sanguis Draxonis and Cera Flava and does not stop to be stirred to it and melt completely; Finally, add Gypsum Fibrosum Preparatum, leave standstill and micro-ly do not stop to be stirred to into even paste after cool, with sterile vessel subpackage and to be placed in cleaning ambient for subsequent use.
Embodiment tri-
The diabetic foot ulcer external medicine composition of the present embodiment, Chinese medicine composition raw material comprises following component by weight: 28 parts of Rhizoma Coptidis parts, 18 parts of Radix Notoginseng, 28 parts of Radix Arnebiae (Radix Lithospermi)s, 16 parts of Radix Salviae Miltiorrhizaes, 22 parts of Cortex Phellodendris, 10 parts of Olibanums, 10 parts of Myrrhas, 10 parts of Sanguis Draxonis, 10 parts, Cera Flava, 32 parts of Gypsum Fibrosum Preparatum.
Rhizoma Coptidis, Radix Notoginseng, Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae, Cortex Phellodendri, Olibanum, Myrrha are soaked 8 days in proportion in Oleum Sesami; Then, endure to slightly bitter with slow fire, wherein undissolved contaminant filter after falling boils Oleum Sesami, successively puts into Sanguis Draxonis and Cera Flava and does not stop to be stirred to it and melt completely; Finally, add Gypsum Fibrosum Preparatum, leave standstill and micro-ly do not stop to be stirred to into even paste after cool, with sterile vessel subpackage and to be placed in cleaning ambient for subsequent use.
Embodiment tetra-
The diabetic foot ulcer external medicine composition of the present embodiment, Chinese medicine composition raw material comprises following component by weight: 15 parts of Rhizoma Coptidis parts, 7 parts of Radix Notoginseng, 15 parts of Radix Arnebiae (Radix Lithospermi)s, 6 parts of Radix Salviae Miltiorrhizaes, 7 parts of Cortex Phellodendris, 3 parts of Olibanums, 3 parts of Myrrhas, 3 parts of Sanguis Draxonis, 3 parts, Cera Flava, 15 parts of Gypsum Fibrosum Preparatum.
Rhizoma Coptidis, Radix Notoginseng, Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae, Cortex Phellodendri, Olibanum, Myrrha are soaked 4 days in proportion in Oleum Sesami; Then, endure to slightly bitter with slow fire, wherein undissolved contaminant filter after falling boils Oleum Sesami, successively puts into Sanguis Draxonis and Cera Flava and does not stop to be stirred to it and melt completely; Finally, add Gypsum Fibrosum Preparatum, leave standstill and micro-ly do not stop to be stirred to into even paste after cool, with sterile vessel subpackage and to be placed in cleaning ambient for subsequent use.
Embodiment five
The diabetic foot ulcer external medicine composition of the present embodiment, Chinese medicine composition raw material comprises following component by weight: 22 parts, 15 parts of Radix Notoginseng, 22 parts of Radix Arnebiae (Radix Lithospermi)s, 12 parts of Radix Salviae Miltiorrhizaes, 15 parts of Cortex Phellodendris, 10 parts of Olibanums, 10 parts of Myrrhas, 10 parts of Sanguis Draxonis, 10 parts, Cera Flava, 22 parts of Gypsum Fibrosum Preparatum.
Rhizoma Coptidis, Radix Notoginseng, Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae, Cortex Phellodendri, Olibanum, Myrrha are soaked 7 days in proportion in Oleum Sesami; Then, endure to slightly bitter with slow fire, wherein undissolved contaminant filter after falling boils Oleum Sesami, successively puts into Sanguis Draxonis and Cera Flava and does not stop to be stirred to it and melt completely; Finally, add Gypsum Fibrosum Preparatum, leave standstill and micro-ly do not stop to be stirred to into even paste after cool, with sterile vessel subpackage and to be placed in cleaning ambient for subsequent use.
The diabetic foot ulcer external medicine composition of above-described embodiment, not only can make paste, the carrier that also can add medical science to accept is made preparation, such as making liquid lotion by pharmaceutical carrier, affected part is cleaned, or powder powder spreads on wound place, be certainly preferably ointment dosage form, these can adopt existing commercial process all can realize.When application, in the situation that not affecting this Chinese medicine composition effect, can add one or more for example, for improving or treat the Chinese medicine of accompanied symptoms: the edema that deficiency of spleen-YANG and kidneyYANG, the wet Inner of water stop causing, the Rhizoma Atractylodis Macrocephalae, Poria, Rhizoma Alismatis, Semen Plantaginis tonneau urine; The gas that Rhizoma Zingiberis Recens temperature aproll is cold; Radix Achyranthis Bidentatae priming is descending, strong waist knee joint; If cardiopalmus, lip dark purple, deficient and rapid pulse or knot generation, for pathogenic water superinverse, in congestion, to stop, benefit is reused Radix Aconiti Lateralis Preparata, and failure of the kidney in receiving QI is reused Radix Ginseng, Gecko, Fructus Schisandrae Chinensis, Fructus Corni, Concha Ostreae, Os Draconis, in case collapse syndrome caused by dyspnea; Dizzy: Mantidis, Ramulus Uncariae Cum Uncis, Concha Haliotidis suppressing the hyperactive liver and subsiding YANG, Radix Scutellariae, Fructus Gardeniae clearing away liver-fire, Radix Achyranthis Bidentatae, the Cortex Eucommiae, Herba Taxilli invigorating the liver and kidney, Caulis Polygoni Multiflori, lies prostrate refreshing tranquilizing by nourishing the heart.The deficiency of YIN more very person adds Radix Rehmanniae, Radix Scrophulariae, Poria cum Radix Pini, Caulis Polygoni Multiflori, adds Radix Polygalae, Semen Ziziphi Spinosae (parched), honey-fried BULBUS LILII with tranquilizing by nourishing the heart; If see dizzy wish servant, vomiting and nausea, numb hand and foot or the sound that trembles, have the positive gesture of moving wind-transformation, adds the product of the town liver endogenous wind stopping such as Concha Margaritifera, Os Draconis, Concha Ostreae, Cornu Saigae Tataricae.Stranguria: Semen Plantaginis, Herba Polygoni Avicularis, Herba Dianthi, Talcum is treating stranguria dampness removing in side.Add Radix Paeoniae, Radix Glycyrrhizae can relieving spasm to stop pain.
Clinical experiment example
The contrast embodiment of the present invention 1 Chinese medicinal ointment adds effectiveness and the safety to chronic diabetes ulcer of foot between standard surgical intervention and simple Standard surgical treatment and evaluates.
Inclusive criteria: (1) diabetics (1 type or 2 types); (2) 18 years old to the 85 years old age; (3) diabetic foot ulcer be classified as Wagner classification 1-3 level; (4) diabetic duration is more than 5 years, and ulcer of foot is more than 12 weeks; (5) can and be ready informed consent; (6) patient 0.7≤ABI≤1.2, and/or to suffer from sufficient doppler waveform be two phase waves or triphasic wave.
Exclusion standard: (1) simple ischemic ulcer; (2) ulcer is more than ankle joint, or below ankle joint, needs amputee but merge serious, life-threatening infection; (3) gestation, preparation gestation or women breast-feeding their children; (4) severe cardiac renal failure, or suffer from mental sickness and can not participate in treatment and the person of following up a case by regular visits to; (5) merge life-threatening serious primary disease as malignant tumor, disease in the blood system, HIV positive; (6) be associated with serious malnutrition or have hemorrhage history person; (7) to certain composition allergy sufferers in sugar foot ulcer-treating capsule.
The observation index of Clinical Follow-up comprises: ulcer (ulcer situation, area and/or Wagner ' s classification), laboratory parameters (blood glucose, routine blood test, routine urinalysis, liver function, renal function) and adverse events.Laboratory detect be defined in the 0th day, the 4th week, the 12nd week, the 24th week, allow use hypoglycemic medicine, antihypertensive drugs and lipid-regulation medicine, but other external used medicine bans use of, and comprises topical antibiotic.As long as allow use antibiotic while merging deep infection or systemic infection symptom as heating, blood leukocytes rising etc.
Efficacy evaluation: main effectively terminal event: the healing completely of ulcer and the improvement of ulcer.The healing completely of ulcer is defined as ulcer surface 100% and is covered by epithelial cell, without oozing out, does not also need dressing change.The improvement of ulcer is defined as ulcer Wagner classification and reduces by 1 rank above (comprising 1 rank) and/or ulcer area and dwindle more than 50% and (comprise 50%).Less important effective terminal event: constituent and healing time that ulcer is improved are defined as secondary endpoints event.
Escape mechanism: (1) patient refuses further to adopt which to treat; (2) patient's diabetic foot ulcer worsens, and cannot continue expectant treatment, needs the meddlers such as surgery amputation (toe); (3) patient's ordinary circumstance worsens, and occurs the severe complication such as pyemia, death etc.
Therapeutic Method: all patients that include in are all without the eluting phase, and the patient after including in adds diabetic foot ulcer external medicine composition treatment (treatment group) according to the pro rate of 1:1 to different treatment groups difference Acceptable criterion surgical interventions (matched group) and Standard surgical treatment immediately.Diabetic foot ulcer external medicine composition is applied in ulcer surface by treatment group, same high with the ulcer degree of depth.According to actual needs or the suggestion of expert group determine to change dressings the time, 1 to 3 day, general interval, (ulcer of 24 weeks observation period healing) or full 24 week observation period (ulcer not healing in 24 week observation period) until ulcer heals completely.For the patient of ulcer healing, still follow-up observation will be continued until full 24 week observation period.
58 patients of this research are assigned to respectively treatment group (29 example) or matched group (29 example) according to randomizing scheme, treat after 24 weeks, ulcer improvement rate (treatment group vs. matched group) is at the 4th Zhou Shiwei (37.5%vs.29.2%; P=0.760), the 12nd week is (79.2%vs.41.7%; P=0.017) the and 24th week (91.7%vs.50%; P=0.003).Treatment group is all effective in matched group, points out diabetic foot ulcer external medicine composition treatment group of the present invention to be significantly better than Standard surgical treatment group in ulcer aspect improving.The clinical trial of this project confirms that diabetic foot ulcer external medicine composition of the present invention is to the potential efficacy and saferry of chronic diabetes ulcer of foot, and prompting diabetic foot ulcer external medicine composition can accelerate the Healing Rate of chronic diabetes ulcer of foot.
Safety: compared with Western medicine, the toxic and side effects of Chinese medicine is relative with untoward reaction less, the more oral or vein ill effect of external application Chinese medicine still less.The qualification of Chinese medicine of the present invention, the preparation of medicine and quality standard detect and have instructed by the expert of Natural Product Chemical Key Laboratory, Chinese Academy of Sciences, Guizhou Pr.And adopt high performance liquid chromatography (HPLC) to detect the wherein concentration of emodin and chrysophanol.Every batch sample all must be carried out Hygienic determination, can allow to enter clinical use as long as reach the sample of aseptic requirement.In this research follow-up period of 6 months, there is not the side reactions such as disease in the blood system, liver function injury, renal function injury and skin allergy in patient.Although have the generation (each 2 examples) of wound pain event, its incidence rate is there was no significant difference between two treatment groups.This illustrates that Chinese medicine composition of the present invention has reliable safety aspect treatment diabetic foot ulcer.
The quality standard research of Chinese medicine composition of the present invention: in order to control the inherent quality of this product, guarantee drug effect, adopt thin layer chromatography (TLC) method to carry out identification experiment to the ingredient such as Rhizoma Coptidis, Radix Et Rhizoma Rhei in Natural Product Chemical Key Laboratory, Chinese Academy of Sciences, Guizhou Pr, and adopted high performance liquid chromatography (HPLC) method to measure the content of the active ingredient emodin in unguentum, chrysophanol.
Chinese medicine composition Hygienic determination method of the present invention: observe in 12 culture dishs of planting and have or not bacterial growth.From on-test to finish all medicines that enter clinical use after according to the Hygienic determination of above method, all find no bacterial growth.
Safety, health giving quality and the medicament categories etc. of TCM Treatment of Diabetes ulcer of foot that this research has adopted evidence-based medicine EBM system evaluation first.Develop a kind of diabetic foot ulcer external application Chinese medicine compound preparation based on system evaluation result.Confirmed that by clinical trial sugared foot heals infections Chinese medicine composition to the potential efficacy and saferry of chronic diabetes ulcer of foot, prompting sugar foot more infections Chinese medicine composition can accelerate the Healing Rate of chronic diabetes ulcer of foot.Provide new method and selection to the treatment of diabetic foot ulcer, made initiative work for alleviating the ailing of patient with diabetic feet and alleviating medical burden.
Model case
1. king xx, female, 70 years old, main suit suffered from diabetes 18 years, and as shown in Figure 1, it uses Chinese medicine composition unguentum of the present invention after 8 weeks to its foot disease symptom, and its therapeutic effect is as shown in Figure 2.
2. an XX, female, 68 years old.Main suit suffers from diabetes 20 years, and left foot toe is first numb, rear pain, and blue about half a year, toe blackout ulceration 4 days, eats antalgica and antibiotic medicine poor effect.Have a medical check-up: the equal ulceration of bipod skin of toe after left foot.Lab testing: fasting glucose 9.2mmol/L.Patient requires external Chinese medicine of the present invention, the 15 basic alleviating pains in sky, left and right, numbness; Wound healing, incrustation after 8 weeks, and guide that patient is careful in one's diet, glucose-lowering treatment on time, and clinical symptoms disappears completely, after half a year, does not follow up a case by regular visits to and does not recur.
3. Lee XX, man, 68 years old.Main suit suffers from diabetes 25 years, and informal dress Or Metformin In Treating diabetes still occur toe pain 2 months, and blue more than 10 days of skin increases the weight of 3 days, antibiotic therapy 10 days, poor effect.Have a medical check-up: biped toe skin is blue, left side 2 toe skin darkenings.Lab testing: fasting glucose 8.7mmol/L.Patient requires external Chinese medicine of the present invention 10 days, and toe erythrosis profit, and guides diet, continues glucose-lowering treatment, and clinical symptoms disappears completely, does not recur again.
Finally explanation is, above embodiment is only unrestricted in order to technical scheme of the present invention to be described, although the present invention is had been described in detail with reference to preferred embodiment, those of ordinary skill in the art is to be understood that, can modify or be equal to replacement technical scheme of the present invention, and not departing from aim and the scope of technical solution of the present invention, it all should be encompassed in the middle of claim scope of the present invention.
Claims (10)
1. a diabetic foot ulcer external medicine composition, is characterized in that: Chinese medicine composition raw material comprises following component by weight: 15～28 parts of Rhizoma Coptidis parts, 5～18 parts of Radix Notoginseng, 15～28 parts of Radix Arnebiae (Radix Lithospermi)s, 3～16 parts of Radix Salviae Miltiorrhizaes, 7～22 parts of Cortex Phellodendris, 1～10 part of Olibanum, 1～10 part of Myrrha, 1～10 part of Sanguis Draxonis, 1～10 part, Cera Flava, 15～32 parts of Gypsum Fibrosum Preparatum.
2. diabetic foot ulcer external medicine composition according to claim 1, is characterized in that: Chinese medicine composition raw material comprises following component by weight: 15～22 parts of Rhizoma Coptidis parts, 7～15 parts of Radix Notoginseng, 15～22 parts of Radix Arnebiae (Radix Lithospermi)s, 6～12 parts of Radix Salviae Miltiorrhizaes, 7～15 parts of Cortex Phellodendris, 3～10 parts of Olibanums, 3～10 parts of Myrrhas, 3～10 parts of Sanguis Draxonis, 3～10 parts, Cera Flava, 15～22 parts of Gypsum Fibrosum Preparatum.
3. diabetic foot ulcer external medicine composition according to claim 2, is characterized in that: Chinese medicine composition raw material comprises following component by weight: 18 parts of Rhizoma Coptidis parts, 9 parts of Radix Notoginseng, 18 parts of Radix Arnebiae (Radix Lithospermi)s, 9 parts of Radix Salviae Miltiorrhizaes, 12 parts of Cortex Phellodendris, 6 parts of Olibanums, 6 parts of Myrrhas, 6 parts of Sanguis Draxonis, 6 parts, Cera Flava, 18 parts of Gypsum Fibrosum Preparatum.
4. according to the diabetic foot ulcer external medicine composition described in the arbitrary claim of claim 1-3, it is characterized in that: this Chinese medicine composition can add one or more for improving or treat the Chinese medicine of accompanied symptoms while use.
5. according to the diabetic foot ulcer external medicine composition described in the arbitrary claim of claim 1-3, it is characterized in that: the preparation that the pharmaceutical carrier that this Chinese medicine can add medical science to accept is made.
6. diabetic foot ulcer external medicine composition according to claim 5, is characterized in that: described Chinese medicine composition is unguentum.
7. a preparation method for diabetic foot ulcer external medicine composition claimed in claim 1, is characterized in that: comprise the following steps:
By setting weight part, Rhizoma Coptidis, Radix Notoginseng, Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae, Cortex Phellodendri, Olibanum, Myrrha are added in Oleum Sesami and soak rear decoction to slightly bitter, after impurity screening, continue to decoct to Oleum Sesami and boil, then adding successively the Sanguis Draxonis of setting weight part and Cera Flava to be stirred to it melts completely, after finally adding the Gypsum Fibrosum Preparatum of setting weight part, stir, obtain diabetic foot ulcer external medicine composition.
8. the preparation method of diabetic foot ulcer external medicine composition according to claim 7, is characterized in that: by setting weight part, Rhizoma Coptidis, Radix Notoginseng, Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae, Cortex Phellodendri, Olibanum, Myrrha are added and in Oleum Sesami, soak 3-8 days.
9. the preparation method of diabetic foot ulcer external medicine composition according to claim 8, is characterized in that: in Oleum Sesami, soak 6 days.
10. a diabetic foot ulcer external medicine composition claimed in claim 1, is characterized in that: the application of this Chinese medicine composition in the medicine of preparing diabetic foot ulcer.
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104257785A (en) * | 2014-10-14 | 2015-01-07 | 中国人民解放军第三军医大学第一附属医院 | Externally applied traditional Chinese medicine composition for treating diabetic foot |
| CN104857186A (en) * | 2015-06-19 | 2015-08-26 | 济南邦文医药科技有限公司 | Traditional Chinese medicine for treating dampness and heat accumulation type diabetic foot ulcer |
| CN105796897A (en) * | 2016-04-11 | 2016-07-27 | 孔庆来 | Pharmaceutical composition for treating diabetic feet |
| CN106860767A (en) * | 2017-04-12 | 2017-06-20 | 沈清文 | A kind of Chinese medicine preparation closed for promoting sore to recover from injury and preparation method thereof |
| CN109464573A (en) * | 2018-12-25 | 2019-03-15 | 威海惠高生物科技有限公司 | For treating diabetes chronic ulcer, the Chinese medicine oil yarn of gangrene and method |
| CN111920937A (en) * | 2020-09-23 | 2020-11-13 | 扬州大学附属医院 | External traditional Chinese medicine composition for treating diabetic foot ulcer and preparation method thereof |
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| CN101926872B (en) * | 2009-05-08 | 2013-11-06 | 韩会民 | Chinese medicinal detoxifying myo-regeneration paste for treating diabetic foot ulcer and preparation method thereof |
| CN101991688A (en) * | 2009-08-20 | 2011-03-30 | 徐荣祥 | Application of medicinal composition to the preparation of medicament for treating diabetic ulcers |
| CN101987152A (en) * | 2010-08-24 | 2011-03-23 | 赵建勇 | Ointment for treating diabetes foot ulcer |
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| CN104257785A (en) * | 2014-10-14 | 2015-01-07 | 中国人民解放军第三军医大学第一附属医院 | Externally applied traditional Chinese medicine composition for treating diabetic foot |
| CN104857186A (en) * | 2015-06-19 | 2015-08-26 | 济南邦文医药科技有限公司 | Traditional Chinese medicine for treating dampness and heat accumulation type diabetic foot ulcer |
| CN105796897A (en) * | 2016-04-11 | 2016-07-27 | 孔庆来 | Pharmaceutical composition for treating diabetic feet |
| CN105796897B (en) * | 2016-04-11 | 2020-03-17 | 孔庆来 | Pharmaceutical composition for treating diabetic foot |
| CN106860767A (en) * | 2017-04-12 | 2017-06-20 | 沈清文 | A kind of Chinese medicine preparation closed for promoting sore to recover from injury and preparation method thereof |
| CN116920054A (en) * | 2018-08-24 | 2023-10-24 | 王庆友 | Traditional Chinese medicine formula for treating diabetic foot gangrene/callus ulcer |
| CN109464573A (en) * | 2018-12-25 | 2019-03-15 | 威海惠高生物科技有限公司 | For treating diabetes chronic ulcer, the Chinese medicine oil yarn of gangrene and method |
| CN111920937A (en) * | 2020-09-23 | 2020-11-13 | 扬州大学附属医院 | External traditional Chinese medicine composition for treating diabetic foot ulcer and preparation method thereof |
| CN116920065A (en) * | 2023-09-04 | 2023-10-24 | 侯涛 | Ointment for treating burns and scalds and preparation method thereof |
| CN117582401A (en) * | 2023-12-07 | 2024-02-23 | 唐宁医药科技(济南)有限公司 | Diabetic foot gel and preparation method thereof |
| CN117582401B (en) * | 2023-12-07 | 2024-04-26 | 唐宁医药科技(济南)有限公司 | Diabetic foot gel and preparation method thereof |
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