CN103893458B - Diabetic foot ulcer external medicine composition, preparation method and applications - Google Patents
Diabetic foot ulcer external medicine composition, preparation method and applications Download PDFInfo
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Abstract
The present invention discloses a kind of diabetic foot ulcer external medicine composition, traditional Chinese medicine composite includes the coptis by weight, pseudo-ginseng, Asian puccoon, the red sage root, golden cypress, frankincense, myrrh, dragon's blood, beeswax, calcined gypsum, acted synergistically between material, by clearing heat and detoxicating, it is promoting blood circulation and removing blood stasis, the blood vessel of whole body is set to recover elasticity, by original blood supply insufficiency to tending to normal slow process, Gene regulation element and effective active molecule in Chinese medicine material enter blood, through diseased region, during steady regulation, based on nourishing liver and kidney, repair the impaired histoorgan of human body, progressively control the pathogenesis of diabetes, adjust nerve system of human body, stimulate circulation, play coordination and complex treatment function, fundamentally thorough reverting diabetes pathogenesis, body is set to reach rehabilitation；Putrefaction-removing granulation-promoting, warming meridian, qi and activate blood circulation mitigate limb pain, and the infection of control sore face improves local microcirculation, strengthens the two-way transhipment function of endothelial cell, improves perineural conduction of velocity, promotion organization reparation and the healing of the surface of a wound.
Description
Technical field
The present invention relates to a kind of medicine for treating diabetes, more particularly to a kind of diabetic foot ulcer external application Chinese medicine combination
Thing, preparation method and applications.
Background technology
Diabetes are a kind of common diabetic complications, and it has a strong impact on patient's labour capacity and quality of life.Sugar
Urine foot disease ulcer is the main clinical manifestation of diabetes, and its amputation rate is 15-20 times of non-diabetic patients, research prompting sugar
The related All-cause death rate of urine patient amputation compares more than 5 times of rise compared with non-diabetic patients.The existing diabetic of China
About 9,000 2 million, the diabetes incidence of disease is about 0.9%-14.5%.Diabetes give social medical resource to bring heavy burden.
In western countries, the cost of diabetic foot ulcer is 16000-27000 dollars/example patient, and the health care costs of amputation are up to
43000-64000 dollars/example patient.In developing country, diabetes consume about 40% health resources, and China there is no official
Number formulary evidence, averagely calculates according to my section's diabetes inpatient, and every patient with diabetic feet mean treatment expense is about 6-8 ten thousand
RMB.But the clinical treatment of diabetes but lacks effective measures always.Comprehensive recent domestic document is to diabetes
Foot mainly has following treatment method：
(1) blood glucose is controlled：As treating other complication, treatment diabetic foot ulcer must control hyperglycaemia first.
The pathologic basis of diabetic foot ulcer is microangiopathies, and control hyperglycaemia can improve microcirculation, reduces body fluid and albumen oozes out,
A large amount of leucocytes is strengthened the anti-infection ability of local organization between entering tissue, mitigate peripheral neuropathy, increase neurotrophy
Supply, is conducive to the wound healing of infection and gangrene.Therefore control hyperglycaemia is to treat this sick premise.There is limb in diabetes
During the gangrene of end, it is necessary to use insulin control blood glucose instead.
(2) blood circulation is improved：Such as 654-2, ligustrazine, ginkgo biloba p.e, prostaglandin E1, urokinase medicine
Expansible whole body arteriolovenular, increases surrounding Microcirculation blood volume, reduces resistance of blood flow, improves microcirculation.
(3) it is anti-infective：It is anti-infective including general infection and local infection, effective antibiotic infection control, infection should be selected
The quality of control, directly affects blood glucose and ulcer of foot healing.
(4) surgical operation and PCI：Arterial bracket, balloon expandable, artery plaque ablation, artery plaque rotary-cut
Equipment needed for art, artificial blood vessel bridging etc. is accurate expensive, and wound is heavy, risk is big, costly, complication is more, the death rate is high, patient
Compliance is poor.
(5) stem-cell therapy：Required equipment is accurate expensive, is limited by ethics, most hospitals can not carry out, and long term is treated
Effect has to be seen.
(6) decompression limb tool：Mainly include Full connected gypsum, brace of detachably walking.The generation of diabetic foot ulcer with
Local pressure abnormal distribution is closely related, and the mechanism of action of decompression limb tool is that the pressure for bearing the surface of a wound is transferred to normal structure,
So as to play a part of protecting the surface of a wound.Full connected gypsum needs experienced doctor's operation, therefore influences it to a certain extent
Clinical expansion.It has the disadvantage to make troubles to patient, to patient's disabling with trauma surface infestation and the diabetes of osteomyelitis.Can
Dismounting walking brace overcomes the shortcoming of Full connected gypsum, makes more complicated, requires higher to operation doctor.
(7) biological dressing：With the development of biotechnology, traditional dressing is updated, and has been occurred in that now
Many new dressing are such as：Semi-permeable poly film dressing has the effect that the surface of a wound is harmful to diffusate that absorbs；Promogran is one
The dressing containing collagen and oxidized regenerated cellulose is planted, can be by reducing the digestive enzyme (neutrophil leucocyte in wound exudate
Enzyme, fibrinolysin, matrix metalloproteinase) change the surface of a wound microenvironment；Alginate dressing is that a kind of absorbable gel is applied
Material, the effect with activation of chronic surface of a wound macrophage；Negative pressure therapeutic devices will form negative pressure between the surface of a wound and dressing, it is divided into
Continuous negative pressure is treated and intermittent negative pressure treatment, and negative pressure treatment can eliminate chronic edema, reduces the afterload of thin vessels, increase office
Portion's CBF, promotes the formation of granulation tissue.Every kind of dressing has a kind of theories integration in a word, but often most shortages are effective
Clinical evidence, but its shortcoming is that less stable and absorption sepage are indifferent.
(8) local cells are transplanted：Human dermis' cell culture transplanting is to plant fibroblasts of adult human dermis in biological support
Cultivated, the growth that corium sub supports epidermal cell can be formed after 2 weeks.Its advantage is can to discharge to be cured with the surface of a wound
Relevant growth factor, cell factor, protease, intra platelet free calcium element, CT-102 are closed, CT-102 can discharge a variety of growths
The factor includes：PDGF-BB, EGF, transforming growth factor-β, Desmocyte growth factor
Son, these growth factors can promote granulation tissue formation and epithelialization, accelerate ulcer healing.Current U.S.'s food and medicine pipe
Reason office, which has allowed for PDGF-BB, is used for the treatment of the diabetes surface of a wound.Platelet derived growth factor-
BB expensive prices.EGF is the fibroblast mitogen of dose dependent.
(9) granulocyte colony stimulating factor (Granulocyte-colony stimulating factor, GCSF) is main
The patient of diabetes trauma surface infestation is applied to, it can adjust the propagation of neutrophil leucocyte, differentiation, ripe and be released into outside
All blood circulations, it has the disadvantage to cause high blood coagulation state, induces myocardial infarction, thrombosis.
(10) local debridement：Diabetic foot ulcer is performance of the diabetes systemic disease in a local most serious,
Now partial cut drainage, debridement dressing are extremely important, and the debridement of diabetes and the debridement of surgery Other diseases are that have
Important difference, using " ingurgitation formula debridement " more than surgery, and the debridement contrast of diabetes, use more and " nibble formula
Debridement ".
(11) external application Chinese medicine paste：Although diabetic foot method is more, most of Medical Devices are expensive, treatment
Costly, uncertain therapeutic efficacy is cut, risk is big, complication is more, found in clinic safely and effectively, reasonable price, risk be low, complication
Few treatment method annoyings clinician always.Treatment by Chinese herbs is China's traditional medicine, and it is in diabetic foot ulcer treatment
Some superiority has been highlighted, but the domestic literature report Diabetes Mellitus Treated With Traditional Chinese Medicine ulcer of foot overwhelming majority is clinical observation, and it is acted on
Mechanism still quotes original theory of traditional Chinese medical science such as：Clearing heat and detoxicating, promoting blood circulation and removing blood stasis, putrefaction-removing granulation-promoting, swelling and pain relieving etc..
According to the evaluation of " international diabetes cooperation tissue ", there is clear and definite evidence-based to cure in the treatment method of diabetic foot ulcer
The only hyperbaric oxygen and closed negative pressure for learning evidence attract treatment, and other therapies there is no evidence-based to cure including various Local out dressing medicines
Evidence is learned to support.Chinese medicine is used for treatment skin trauma always includes diabetic foot ulcer, and its mechanism is clearing heat and detoxicating, promoting blood circulationization
The stasis of blood and promotion wound healing.However, on its evidence-based lack of evidence of the curative effect of these therapies, not yet obtaining international and national doctor trained in Western medicine
Boundary recognizes.Reason is：(1) clinical research of TCM Treatment of Diabetes ulcer of foot is of low quality, its curative effect it is repeatable
Property is poor, thus confidence level is under suspicion；(2) compared with doctor trained in Western medicine, the traditional Chinese medical science in terms of thoroughly evaluating curative effect especially objective indicator with
The advantage that doctor trained in Western medicine compares is indefinite；(3) effect of therapy of combing traditional Chinese and Western medicine there is no strict Clinical Evidence.
Although the existing Chinese medicine for the outer application of diabetes have certain curative effect, but it is slow to work, and the course for the treatment of is long, security and
Health giving quality is poorer.
The content of the invention
In view of this, it is an object of the invention to provide a kind of diabetic foot ulcer external medicine composition, preparation method
And its apply, the Chinese medicine composition has evident in efficacy, rapid-action, short treating period, safe, good effect.
The diabetic foot ulcer external medicine composition of the present invention, traditional Chinese medicine composite includes with the following group by weight
Point：15~28 parts of the coptis, 5~18 parts of pseudo-ginseng, 15~28 parts of Asian puccoon, 3~16 parts of the red sage root, 7~22 parts of golden cypress, frankincense 1~
10 parts, 1~10 part of myrrh, 1~10 part of dragon's blood, 1~10 part of beeswax, 15~32 parts of calcined gypsum；
Further, traditional Chinese medicine composite includes following components by weight：15~22 parts of the coptis, pseudo-ginseng 7~15
Part, 15~22 parts of Asian puccoon, 6~12 parts of the red sage root, 7~15 parts of golden cypress, 3~10 parts of frankincense, 3~10 parts of myrrh, 3~10 parts of dragon's blood,
3~10 parts of beeswax, 15~22 parts of calcined gypsum；
Further, traditional Chinese medicine composite includes following components by weight：18 parts of the coptis, 9 parts of pseudo-ginseng, 18 parts of Asian puccoon,
9 parts of the red sage root, 12 parts of golden cypress, 6 parts of frankincense, 6 parts of myrrh, 6 parts of dragon's blood, 6 parts of beeswax, 18 parts of calcined gypsum；
Further, it can be added when the Chinese medicine composition is used one or more for improving or treating the Chinese medicine of accompanying symptoms；
Further, the Chinese medicine composition is that can add the preparation that the acceptable pharmaceutical carrier of medical science is made；
Further, the Chinese medicine composition is paste.
Invention additionally discloses a kind of preparation method of diabetic foot ulcer external medicine composition, comprise the following steps：
The coptis, pseudo-ginseng, Asian puccoon, the red sage root, golden cypress, frankincense, myrrh are added by setting weight part and decocted after being soaked in sesame oil
To slightly bitter, continue to decoct after impurity screening to boil to sesame oil, the dragon's blood and beeswax for then sequentially adding setting weight part are stirred
Mix to it and be completely melt, stirred after the calcined gypsum for being eventually adding setting weight part, produce diabetic foot ulcer external application Chinese medicine
Composition；
Further, the coptis, pseudo-ginseng, Asian puccoon, the red sage root, golden cypress, frankincense, myrrh are added in sesame oil by setting weight part and soaked
3-8 days；
Further, soaked 6 days in sesame oil.
Invention additionally discloses a kind of application of diabetic foot ulcer external medicine composition, the Chinese medicine composition can be used for making
Application in the medicine of standby diabetic foot ulcer.
Beneficial effects of the present invention：The diabetic foot ulcer external medicine composition of the present invention, preparation method and applications,
Dragon's blood is sweet salty flat for property, and the function of myogenic is relieved pain, restrained with promoting blood circulation to remove blood stasis, there is antimycotic effect.Frankincense, myrrh, containing tree
Fat, volatile oil, there is preferable promoting blood circulation, Repercusion analgesia, promoting pus discharge and tissue regeneration effect.
Calcined gypsum, property is sweet, pungent, puckery, cold, has the effect of hygroscopic myogenic, sore and stops blooding, can suppress bacterium, especially to golden yellow
Color staphylococcus, Pseudomonas aeruginosa are sensitive, and gypsum also has heat-clearing, analgesic activity, has dilating effect to tip capillary, can promote
Enter local blood circulation.
Pseudo-ginseng is warm-natured, sweet, slight bitter.Major function：Hemostasis, dissipates the stasis of blood, subsides a swelling, analgesic.《Jade seizes medicine solution》：Stop blooding with battalion,
The row stasis of blood, row hemostasis of promoting blood circulation and hold back new blood.Modern study, can promote hematopoiesis, removing blood stasis for promoting tissue regeneration.
The coptis, clearing heat and detoxicating, hypoglycemic, antibacterial.
Red sage root promoting blood circulation, cool blood to disappear carbuncle, raw new blood, remove extravesated blood.
Golden cypress is bitter, trembles with fear.Major function：Heat-clearing and damp-drying drug, purging intense heat and detonicating, except hectic fever due to yin clearind deficient heat.
For damp-heat dysentery, jaundice, sore swollen toxin, eczema itch ....Modern study, golden cypress has anti-inflammatory, soothing the liver.
Beeswax, removing toxic substances；Myogenic；Hemostasis；Analgesic therapy.Main ulcer carbuncle on the back, ulcer is to hold back.
Acted synergistically between said components material, it is promoting blood circulation and removing blood stasis by clearing heat and detoxicating, the blood vessel of whole body is recovered elasticity, by
Originally blood supply insufficiency enters blood to the Gene regulation element and effective active molecule tended in normal slow process, Chinese medicine material
Liquid, go directly diseased region, during steady regulation, based on nourishing liver and kidney, repairs the impaired histoorgan of human body, progressively controls
The pathogenesis of diabetes processed, adjusts nerve system of human body, stimulates circulation, and coordination and complex treatment function is played, from root
Thorough reverting diabetes pathogenesis, makes body reach rehabilitation in sheet；Putrefaction-removing granulation-promoting, warming meridian, qi and activate blood circulation）Mitigate suffering limb
Pain, control sore face infection, improves local microcirculation, strengthens the two-way transhipment function of endothelial cell, improves perineural pass
Lead speed, promotion organization reparation and the healing of the surface of a wound.
Internal organs interior can also be adjusted simultaneously, it is quick to repair patients' neural's vascular lesion, promote local edema elimination, it is strong to improve
The blood fortune of lower limb is unimpeded, slows down that suffering limb of the patient with diabetic feet caused by blood-vessels what hinders is numb, have an intense pain, and can effectively promote
Enter diabetes lower limb to fester the quick healing of the surface of a wound；Treatment time：The basic pain of alleviation in 15 or so days, numbness；2 months or so
Wound healing, incrustation.
Brief description of the drawings
Fig. 1 is the diabetes symptom figure before treatment；
Fig. 2 is the design sketch after treating 8 weeks.
Embodiment
The diabetic foot ulcer external medicine composition of the present invention, traditional Chinese medicine composite includes with the following group by weight
Point：15~28 parts of the coptis, 5~18 parts of pseudo-ginseng, 15~28 parts of Asian puccoon, 3~16 parts of the red sage root, 7~22 parts of golden cypress, frankincense 1~
10 parts, 1~10 part of myrrh, 1~10 part of dragon's blood, 1~10 part of beeswax, 15~32 parts of calcined gypsum.
In the present embodiment, traditional Chinese medicine composite includes following components by weight：15~22 parts of the coptis, pseudo-ginseng 7~
15 parts, 15~22 parts of Asian puccoon, 6~12 parts of the red sage root, 7~15 parts of golden cypress, 3~10 parts of frankincense, 3~10 parts of myrrh, dragon's blood 3~10
Part, 3~10 parts of beeswax, 15~22 parts of calcined gypsum.
In the present embodiment, traditional Chinese medicine composite includes following components by weight：18 parts of the coptis, 9 parts of pseudo-ginseng, Asian puccoon 18
Part, 9 parts of the red sage root, 12 parts of golden cypress, 6 parts of frankincense, 6 parts of myrrh, 6 parts of dragon's blood, 6 parts of beeswax, 18 parts of calcined gypsum.
It can be added in the present embodiment, when the Chinese medicine composition is used one or more for improving or treating in accompanying symptoms
Medicine.
In the present embodiment, the Chinese medicine composition is that can add the preparation that the acceptable pharmaceutical carrier of medical science is made；Can be with
Powder, paste is made, aqua etc. is used to wash or external application
In the present embodiment, use preferably for paste and as external application.
Invention additionally discloses a kind of preparation method of diabetic foot ulcer external medicine composition, comprise the following steps：
The coptis, pseudo-ginseng, Asian puccoon, the red sage root, golden cypress, frankincense, myrrh are added by setting weight part and decocted after being soaked in sesame oil
To slightly bitter, continue to decoct after impurity screening to boil to sesame oil, the dragon's blood and beeswax for then sequentially adding setting weight part are stirred
Mix to it and be completely melt, stirred after the calcined gypsum for being eventually adding setting weight part, produce diabetic foot ulcer external application Chinese medicine
Composition.
In the present embodiment, the coptis, pseudo-ginseng, Asian puccoon, the red sage root, golden cypress, frankincense, myrrh are added in sesame oil by setting weight part
Immersion 3-8 days.
It is preferably to be soaked 6 days in sesame oil in the present embodiment.
The diabetic foot ulcer external medicine composition of the present invention, the Chinese medicine composition is preparing the medicine of diabetic foot ulcer
Application in thing.
The Chinese medicine composition of the present invention is further elaborated below by specific embodiment：
Embodiment one
The diabetic foot ulcer external medicine composition of the present embodiment, traditional Chinese medicine composite includes with the following group by weight
Point：18 parts of the coptis, 9 parts of pseudo-ginseng, 18 parts of Asian puccoon, 9 parts of the red sage root, 12 parts of golden cypress, 6 parts of frankincense, 6 parts of myrrh, 6 parts of dragon's blood, beeswax 6
Part, 18 parts of calcined gypsum.
The coptis, pseudo-ginseng, Asian puccoon, the red sage root, golden cypress, frankincense, myrrh are soaked 6 days in sesame oil in proportion；Then, slow fire is used
Endure to slightly it is bitter, will wherein undissolved contaminant filter fall after sesame oil is boiled, be successively put into dragon's blood and beeswax and do not stop to stir
Mix to it and be completely melt；Finally, add calcined gypsum, stand it is micro- it is cool after do not stop stirring into homogeneous paste, with sterile vessel point
Dress is placed in standby in cleaning ambient.
Embodiment two
The diabetic foot ulcer external medicine composition of the present embodiment, traditional Chinese medicine composite includes with the following group by weight
Point：15 parts of the coptis, 5 parts of pseudo-ginseng, 15 parts of Asian puccoon, 3 parts of the red sage root, 7 parts of golden cypress, 1 part of frankincense, 1 part of myrrh, 1 part of dragon's blood, beeswax 1
Part, 15 parts of calcined gypsum.
The coptis, pseudo-ginseng, Asian puccoon, the red sage root, golden cypress, frankincense, myrrh are soaked 3 days in sesame oil in proportion；Then, slow fire is used
Endure to slightly it is bitter, will wherein undissolved contaminant filter fall after sesame oil is boiled, be successively put into dragon's blood and beeswax and do not stop to stir
Mix to it and be completely melt；Finally, add calcined gypsum, stand it is micro- it is cool after do not stop stirring into homogeneous paste, with sterile vessel point
Dress is placed in standby in cleaning ambient.
Embodiment three
The diabetic foot ulcer external medicine composition of the present embodiment, traditional Chinese medicine composite includes with the following group by weight
Point：28 parts of the coptis, 18 parts of pseudo-ginseng, 28 parts of Asian puccoon, 16 parts of the red sage root, 22 parts of golden cypress, 10 parts of frankincense, 10 parts of myrrh, 10 parts of dragon's blood,
10 parts of beeswax, 32 parts of calcined gypsum.
The coptis, pseudo-ginseng, Asian puccoon, the red sage root, golden cypress, frankincense, myrrh are soaked 8 days in sesame oil in proportion；Then, slow fire is used
Endure to slightly it is bitter, will wherein undissolved contaminant filter fall after sesame oil is boiled, be successively put into dragon's blood and beeswax and do not stop to stir
Mix to it and be completely melt；Finally, add calcined gypsum, stand it is micro- it is cool after do not stop stirring into homogeneous paste, with sterile vessel point
Dress is placed in standby in cleaning ambient.
Example IV
The diabetic foot ulcer external medicine composition of the present embodiment, traditional Chinese medicine composite includes with the following group by weight
Point：15 parts of the coptis, 7 parts of pseudo-ginseng, 15 parts of Asian puccoon, 6 parts of the red sage root, 7 parts of golden cypress, 3 parts of frankincense, 3 parts of myrrh, 3 parts of dragon's blood, beeswax 3
Part, 15 parts of calcined gypsum.
The coptis, pseudo-ginseng, Asian puccoon, the red sage root, golden cypress, frankincense, myrrh are soaked 4 days in sesame oil in proportion；Then, slow fire is used
Endure to slightly it is bitter, will wherein undissolved contaminant filter fall after sesame oil is boiled, be successively put into dragon's blood and beeswax and do not stop to stir
Mix to it and be completely melt；Finally, add calcined gypsum, stand it is micro- it is cool after do not stop stirring into homogeneous paste, with sterile vessel point
Dress is placed in standby in cleaning ambient.
Embodiment five
The diabetic foot ulcer external medicine composition of the present embodiment, traditional Chinese medicine composite includes with the following group by weight
Point：22 parts, 15 parts of pseudo-ginseng, 22 parts of Asian puccoon, 12 parts of the red sage root, 15 parts of golden cypress, 10 parts of frankincense, 10 parts of myrrh, 10 parts of dragon's blood, beeswax 10
Part, 22 parts of calcined gypsum.
The coptis, pseudo-ginseng, Asian puccoon, the red sage root, golden cypress, frankincense, myrrh are soaked 7 days in sesame oil in proportion；Then, slow fire is used
Endure to slightly it is bitter, will wherein undissolved contaminant filter fall after sesame oil is boiled, be successively put into dragon's blood and beeswax and do not stop to stir
Mix to it and be completely melt；Finally, add calcined gypsum, stand it is micro- it is cool after do not stop stirring into homogeneous paste, with sterile vessel point
Dress is placed in standby in cleaning ambient.
The diabetic foot ulcer external medicine composition of above-described embodiment, can not only be made paste, can also add doctor
Learn acceptable carrier and preparation is made, such as liquid lotion is made by pharmaceutical carrier, affected part is cleaned, or
It is that powder powder is spread at wound, preferably ointment dosage form certainly, these can use the equal energy of existing commercial process
Realize.Using when, in the case where not influenceing this Chinese medicine composition effect, can add one or more is used to improve or treat simultaneous
The Chinese medicine of card, for example：The wet Inner of the insufficiency of both the spleen and the kindey, water stops caused oedema, the bighead atractylodes rhizome, Poria cocos, rhizoma alismatis, plantain seed tonneau urine；Ginger
The cold gas of warm aproll；Root of bidentate achyranthes priming is descending, strong waist and knee；If palpitaition, lip dark purple, in deficient and rapid pulse or knot generation, be in the evil superinverse of water, extravasated blood
Stop, benefit reuses monkshood, and the failure of the kidney in receiving air reuses ginseng, gekko, the fruit of Chinese magnoliavine, dogwood fruit, oyster, keel, de- with anti-asthma；Dizziness：My god
Horse, yncaria stem with hooks, the shell of seaear are calming the liver, radix scutellariae, cape jasmine clearing away the liver-fire, the root of bidentate achyranthes, the bark of eucommia, Ramulus Taxilli filling liver kidney, Polygonum multiflower knotweed, the refreshing nourishing heart of volt
Calm the nerves.The deficiency of Yin more notably adds radix rehmanniae recen, radix scrophulariae, fushen, Polygonum multiflower knotweed, plus polygala, stir-baked SEMEN ZIZIPHI SPINOSAE, honey-fried BULBUS LILII are with mental-tranquilization；If seeing
Dizziness is intended to fall forward, evil of vomitting, the numb in every limb or sound that trembles, the gesture for having the dynamic wind transmission of sun, plus mother-of-pearl, Os Draconis, raw oyster, antelope's horn etc.
The product of town liver ceases wind.Stranguria：Plantain seed, pivots storage, fringed pink in side, talcum is treating stranguria dampness removing.Add plus Chinese herbaceous peony, radix glycyrrhizae can be stopped with emergency
Bitterly.
Clinical trial example
Contrast between the quasi- surgical intervention of Chinese medicinal ointment mark-on of the embodiment of the present invention 1 and the treatment of simple Standard surgical to chronic sugar
The validity and security for urinating foot disease ulcer are evaluated.
Inclusive criteria：（1）Diabetic's (1 type or 2 types)；（2）18 years old to 85 years old age；（3）Diabetic foot ulcer
It is classified as Wagner and is classified 1-3 grades；（4）Diabetic duration more than 5 years, ulcer of foot is more than 12 weeks；（5）It can and be ready to know
Agree to；（6）Patient 0.7≤ABI≤1.2, and/or it is two phase waves or triphasic wave to suffer from sufficient doppler waveform.
Exclusion standard：(1) simple ischemic ulcer；(2) ulcer is more than ankle-joint, or below ankle-joint, but merge
The infection of serious, life-threatening needs amputee；(3) gestation, preparation gestation or women breast-feeding their children；(4) serious cardiorenal function
Exhaustion, or can not participate in treatment and follow-up person with mental illness；(5) the severe primary disease for merging life-threatening is for example pernicious
Tumour, disease in the blood system, HIV positives；(6) it is associated with serious malnutrition or has hemorrhagic disease history person；(7) to sugar
Certain composition allergy sufferers in sufficient ulcer-treating capsule.
The observation index of Clinical Follow-up includes：Ulcer (ulcer situation, area and/or Wagner ' s classifications), laboratory inspection
Survey index (blood glucose, blood routine, routine urinalysis, liver function, renal function) and adverse events.Test in laboratory regulation the 0th day, the 4th
Week, the 12nd week, the 24th week, it is allowed to which using hypoglycemic medicine, antihypertensive drugs and lipid-regulation medicine, but other external used medicines are forbidden making
With, including topical antibiotic.As long as allowing to make when merging deep infection or general infection symptom are such as generated heat, blood leukocytes are raised
Use antibiotic.
Efficacy evaluation:Main effectively endpoints：The complete healing and the improvement of ulcer of ulcer.The complete healing of ulcer is determined
Justice is covered for ulcer surface 100% by epithelial cell, and nothing is oozed out, it is not required that dressing change.The improvement of ulcer is defined as ulcer
It is more than Wagner classification 1 rank of reduction that (including 1 rank) and/or ulcer area reduce more than 50% (including 50%).It is secondary
Effective endpoints：The constituent and healing time that ulcer improves are defined as secondary endpoints event.
Escape mechanism：（1）Patient's refusal is further treated using which；（2）Diabetes mellitus's ulcer of foot deteriorates,
Expectant treatment can not be continued, it is necessary to surgical amputation（Toe）Deng meddler；（3）Patient's ordinary circumstance deteriorates, and septicopyemia occurs, dead
The severe complication etc. such as die.
Treatment method：All patients included are without the elution phase, and the patient after including is immediately according to 1:1 pro rate is extremely
Different treatment groups receive Standard surgical treatment (control group) and Standard surgical treatment plus diabetic foot ulcer external application Chinese medicine group respectively
Compound treats (treatment group).Diabetic foot ulcer external medicine composition is applied to skin surface by treatment group, with ulcer depth
With high.According to actual needs or the suggestion of expert group determines dressing time, general interval 1 to 3 days, until ulcer heals completely
(ulcer of 24 week observation period healing) or full 24 week observation period (ulcer not healed in 24 week observation period).For ulcer healing
Patient, still will continue follow-up observation until full 24 week observation period.
58 patients of this research are respectively allocated to treatment group (29) or control group (29), treatment according to randomizing scheme
After 24 weeks, ulcer improvement rate (treatment group's vs. control groups) is in the 4th Zhou Shiwei (37.5% vs. 29.2%；P=0.760), the 12nd week
For (79.2% vs. 41.7%;P =0.017) and the 24th week (91.7% vs. 50%;P= 0.003).Treatment group is effective
In control group, the diabetic foot ulcer external medicine composition treatment group of the present invention is pointed out to be significantly better than mark in terms of ulcer improvement
Quasi- surgical intervention group.The clinical test of this project confirms the diabetic foot ulcer external medicine composition of the present invention to chronic diabetes
The potential efficacy and saferry of ulcer of foot, points out diabetic foot ulcer external medicine composition to can speed up chronic diabetes and bursts enough
The Healing Rate of ulcer.
Security:Compared with Western medicine, the toxic side effect of Chinese medicine and adverse reaction are relatively fewer, external application Chinese medicine it is relatively oral or
Vein ill-effect is less.The identification of Chinese medicine, the preparation of medicine and the quality standard detection of the present invention is by Chinese section of Guizhou Province
The expert of natural product chemistry key lab of institute instructs to complete.And it is wherein big using high performance liquid chromatography (HPLC) detection
The concentration of flavine and Chrysophanol.Every batch of sample must carry out Hygienic determination, can permit as long as reaching the sample of sterility requirements
Perhaps Clinical practice is entered.In the follow-up period of this research 6 months, patient does not occur disease in the blood system, hepatic disorder, kidney work(
Can infringement and the side reaction such as allergic.Although there is the generation of surface of a wound pain events（Each 2）, but its incidence is controlled two
There was no significant difference between treatment group.The Chinese medicine composition of this explanation present invention has reliable peace in terms of diabetic foot ulcer is treated
Quan Xing.
The quality standard research of the Chinese medicine composition of the present invention：In order to control the inherent quality of this product, it is ensured that drug effect, expensive
State natural product chemistry key lab of the Chinese Academy of Sciences of province employ thin-layer chromatography (TLC) method to contained by the coptis, rheum officinale etc. into
Divide and carry out identification experiment, and use high performance liquid chromatography (HPLC) method to determine active ingredient emodin, Chrysophanol in paste
Content.
The Chinese medicine composition Hygienic determination method of the present invention:Bacterium life is whether there is in 12 planted culture dishes of observation
It is long.Do not found after the Hygienic determination according to above method from on-test to the medicine for terminating all entrance Clinical practices
There is bacterial growth.
This research uses evidence-based medicine EBM the system evaluation security of TCM Treatment of Diabetes ulcer of foot, health giving quality first
With medicament categories etc..A kind of diabetic foot ulcer external application Chinese medicine compound preparation have developed based on system evaluation result.Pass through clinic
Experiment confirms that sugared foot is cured ulcer Chinese medicine composition to the potential efficacy and saferry of chronic diabetes ulcer of foot, points out sugar foot to be cured ulcer
Chinese medicine composition can speed up the Healing Rate of chronic diabetes ulcer of foot.Treatment to diabetic foot ulcer provides new side
Method and selection, to mitigate the slight illness of patient with diabetic feet and mitigating the work that medical burden has made initiative.
Model case
King xx, female, 70 years old, main suit suffered from diabetes 18 years, and its foot disease symptom is as shown in figure 1, it uses Chinese medicine of the invention
After composition paste 8 weeks, 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, blue about as long as half a year, pin
Toe nigrescence ulceration 4 days, eats antalgica and antiphlogistic effect is not good.Have a medical check-up：The equal ulceration of bipod skin of toe after left foot.Examine in laboratory
Look into：Fasting blood-glucose 9.2mmol/L.Patient requests' external application Chinese medicine of the present invention, the basic pain of alleviation in 15 or so days, numbness；After 8 weeks
Wound healing, incrustation, and guide patient to be careful in one's diet, glucose-lowering treatment on time, and clinical symptoms are wholly absent, and follow-up is not again after half a year
Recurrence.
3. Lee XX, man, 68 years old.Main suit suffers from diabetes 25 years, informal dress Or Metformin In Treating sugar
, still there is toe pain 2 months in urine disease, blue more than 10 day of skin, exacerbation 3 days, antibiotic therapy 10 days, effect
It is not good.Have a medical check-up：Biped toe skin is blue, the toe skin darkening of left side 2.Laboratory examination：Fasting blood-glucose 8.7mmol/L.
Patient requests' external application Chinese medicine of the present invention 10 days, toe erythrosis profit, and guides diet, continues glucose-lowering treatment, and clinical symptoms are complete
Mistake is totally disappeared, is not recurred again.
Finally illustrate, the above embodiments are merely illustrative of the technical solutions of the present invention and it is unrestricted, although with reference to compared with
The present invention is described in detail good embodiment, it will be understood by those within the art that, can be to skill of the invention
Art scheme is modified or equivalent substitution, and without departing from the objective and scope of technical solution of the present invention, it all should cover at this
Among the right of invention.
Claims (9)
1. a kind of diabetic foot ulcer external medicine composition, it is characterised in that：Traditional Chinese medicine composite is by weight by following
Component is constituted：15~22 parts of the coptis, 7~15 parts of pseudo-ginseng, 15~22 parts of Asian puccoon, 6~12 parts of the red sage root, 7~15 parts of golden cypress, breast
Fragrant 3~10 parts, 3~10 parts of myrrh, 3~10 parts of dragon's blood, 3~10 parts of beeswax, 15~22 parts of calcined gypsum.
2. diabetic foot ulcer external medicine composition according to claim 1, it is characterised in that：Traditional Chinese medicine composite
It is made up of by weight following component：18 parts of the coptis, 9 parts of pseudo-ginseng, 18 parts of Asian puccoon, 9 parts of the red sage root, 12 parts of golden cypress, 6 parts of frankincense, do not have
6 parts of medicine, 6 parts of dragon's blood, 6 parts of beeswax, 18 parts of calcined gypsum.
3. the diabetic foot ulcer external medicine composition according to claim 1-2 any claims, it is characterised in that：
The Chinese medicine composition can add one or more for improving or treating the Chinese medicine of accompanying symptoms when using.
4. the diabetic foot ulcer external medicine composition according to claim 1-2 any claims, it is characterised in that：
The Chinese medicine composition is that can add the preparation that the acceptable pharmaceutical carrier of medical science is made.
5. diabetic foot ulcer external medicine composition according to claim 4, it is characterised in that：The Chinese medicine composition
For paste.
6. a kind of preparation method of the diabetic foot ulcer external medicine composition described in claim 1, it is characterised in that：Including
Following steps：
The coptis, pseudo-ginseng, Asian puccoon, the red sage root, golden cypress, frankincense, myrrh are added by setting weight part and decocted after being soaked in sesame oil to micro-
It is micro- bitter, continue to decoct after impurity screening to boil to sesame oil, then sequentially add setting weight part dragon's blood and beeswax stir to
It is completely melt, is stirred after the calcined gypsum for being eventually adding setting weight part, produces the combination of diabetic foot ulcer external application Chinese medicine
Thing.
7. the preparation method of diabetic foot ulcer external medicine composition according to claim 6, it is characterised in that：By setting
Determine parts by weight and the coptis, pseudo-ginseng, Asian puccoon, the red sage root, golden cypress, frankincense, myrrh are added into immersion 3-8 days in sesame oil.
8. the preparation method of diabetic foot ulcer external medicine composition according to claim 7, it is characterised in that：In fiber crops
Soaked 6 days in oil.
9. a kind of application of the diabetic foot ulcer external medicine composition described in claim 1, it is characterised in that：The Chinese medicine group
Compound can be used for the medicine for preparing diabetic 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 |
| 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 |
| CN109350697A (en) * | 2018-08-24 | 2019-02-19 | 王庆友 | Treat diabetic foot gangrene/callosity ulcer Chinese prescription |
| 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 |
| 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 |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101926872A (en) * | 2009-05-08 | 2010-12-29 | 韩会民 | Chinese medicinal detoxifying myo-regeneration paste for treating diabetic foot ulcer and preparation method thereof |
| CN101987152A (en) * | 2010-08-24 | 2011-03-23 | 赵建勇 | Ointment for treating diabetes foot ulcer |
| US20120171298A1 (en) * | 2009-08-20 | 2012-07-05 | Rongxiang Xu | Use of pharmaceutical compositions in preparing pharmaceuticals for treating diabetic ulcer |
-
2014
- 2014-04-18 CN CN201410157890.7A patent/CN103893458B/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101926872A (en) * | 2009-05-08 | 2010-12-29 | 韩会民 | Chinese medicinal detoxifying myo-regeneration paste for treating diabetic foot ulcer and preparation method thereof |
| US20120171298A1 (en) * | 2009-08-20 | 2012-07-05 | Rongxiang Xu | Use of pharmaceutical compositions in preparing pharmaceuticals for treating diabetic ulcer |
| CN101987152A (en) * | 2010-08-24 | 2011-03-23 | 赵建勇 | Ointment for treating diabetes foot ulcer |
Non-Patent Citations (2)
| Title |
|---|
| 循证医学对中医药治疗糖尿病足的临床疗效系统评价研究;李树法;《中国博士学位论文全文数据库》;20111215(第12期);第31、45-49、67、69-70、81-82页 * |
| 糖足愈疡膏对慢性糖尿病足溃疡患者终点事件的影响;李树法等;《中国中西医结合杂志》;20110620;第31卷(第06期);第775-779页 * |
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