CN104161961B - The Chinese medicine for outer use for the treatment of diabetic foot ulcer, preparation method and applications - Google Patents

Abstract

The present invention is disclosed and a kind of treats Chinese medicine for outer use of diabetic foot ulcer and preparation method thereof, the raw material of Chinese medicine preparation includes the Radix Astragali, Scorpio, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Pollen Tyjphae, Cortex Phellodendri, Rhizoma Coptidis, Radix Et Rhizoma Rhei, Radix Angelicae Sinensis, Radix Rubiae, Radix Salviae Miltiorrhizae, Gypsum Fibrosum, the Rhizoma Anemarrhenae, Borneolum Syntheticum by weight, the effective ingredient synergism of each component, blood circulation promoting and blood stasis dispelling is played altogether, detumescence and promoting granulation, the work(of heat-clearing and toxic substances removing evacuation of pus, so that stagnation resolvation network is logical, acra normal circulation of qi and blood, muscle nutrition is sufficient, the skin ulcer meat that disappears is long, effectively cures the ulcer of foot that diabetes cause.

Description

The Chinese medicine for outer use for the treatment of diabetic foot ulcer, preparation method and applications

Technical field

The present invention relates to a kind of medicine for treating diabetes, more particularly to a kind of external application Chinese medicine for treating diabetic foot ulcer Preparation, preparation method and applications.

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.Sugar Urine foot disease ulcer is the main clinical manifestation of diabetic foot, and its amputation rate is 15-20 times of ND, research prompting sugar The related All-cause death rate of urine patient amputation compares more than 5 times of rising compared with ND.The existing diabeticss of China About 9,000 2 million, diabetic foot sickness rate is about 0.9%-14.5%.Diabetic foot brings heavy negative to social medical resource Load.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, diabetic foot consumes about 40% health resourceses, and China there is no official Number formulary evidence, averagely calculates according to my section's diabetic foot inpatient, and every 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 is to diabetes Foot mainly has following Therapeutic Method：

(1) control blood glucose：As other complication are treated, treatment diabetic foot ulcer must control hyperglycemia first. The pathologic basis of diabetic foot ulcer are microangiopathies, and control hyperglycemia can improve microcirculation, reduce body fluid and albumen oozes out, Make a large amount of leukocyte enter the anti-infection ability for strengthening local organization between tissue, mitigate peripheral neuropathy, increase neurotrophy Supply, is conducive to infecting and gangrenous wound healing.Therefore control hyperglycemia is the premise for treating primary disease.There is limb in diabetes During the gangrene of end, it is necessary to use insulin control blood glucose instead.

(2) improve blood circulation：The medicines such as such as 654-2, ligustrazine, Ginkgo Biloba Extract, PGE1, urokinase can Expansion whole body arteriolovenular, increases surrounding Microcirculation blood volume, reduces resistance of blood flow, improve microcirculation.

(3) infection：Infection includes systemic infection and local infection, should select effective antibiotics infection control, infection The quality of control, directly affects blood glucose and ulcer of foot healing.

(4) surgical operation and interventional therapy：Arterial bracket, balloon expandable, artery plaque ablation, artery plaque rotary-cut art, The equipment needed therebies such as artificial blood vessel bridging are accurate expensive, and wound is heavy, risk is big, costly, complication is more, mortality rate is high, Bing Renyi It is poor from property.

(5) stem-cell therapy：Equipment needed thereby is accurate expensive, is limited by ethics, and most hospitals can not carry out, late result Have to be seen.

(6) reduce pressure limb tool：Mainly include Full connected Gypsum Fibrosum, brace of detachably walking.The generation of diabetic foot ulcer and office Portion's pressure distribution is extremely closely related, and the mechanism of action of the limb tool that reduces pressure is that the pressure that wound surface bears is transferred to normal structure, from And play a part of to protect wound surface.Full connected Gypsum Fibrosum needs experienced doctor's operation, therefore affects which to face to a certain extent Bed is promoted.Which has the disadvantage to make troubles to patient, and the patient with traumatic infection and myelitic diabetic foot is disabled.It is removable The shortcoming that walking brace overcomes Full connected Gypsum Fibrosum is unloaded, makes more complicated, it is higher to operating doctor to require.

(7) biological dressing：With the development of biotechnology, traditional dressing is updated, has been occurred in that now very More new dressing is such as：Semi-permeable poly film dressing has the effect for absorbing the harmful transudate of wound surface；Promogran is that one kind contains There is the dressing of collagen and oxidized regenerated cellulose, can pass through to reduce digestive enzyme (neutrophilic granulocyte enzyme, the fibrinolytic in wound exudate Enzyme, matrix metalloproteinase) change wound surface microenvironment；Alginate dressing is a kind of absorbable gel dressing, with sharp The effect of chronic wound macrophage living；Negative pressure therapeutic devices will form negative pressure between wound surface and dressing, it is divided into continuous negative pressure Treatment and intermittent negative pressure treatment, negative pressure treatment can eliminate chronic edema, reduce the afterload of thin vessels, increase regional flow Amount, promotes the formation of granulation tissue.Every kind of dressing in a word has a kind of theories integration, but often most effectively clinics that lack are demonstrate,proved According to, but its shortcoming is that less stable and absorption sepage are indifferent.

(8) local cells transplanting：Human dermis' cell culture transplanting is fibroblasts of adult human dermis to be planted in biological support Cultivated, the growth that corium sub supports epidermis cell after 2 weeks, can be formed.Its advantage can be release and wound healing Relevant somatomedin, cytokine, protease, intra platelet free calcium element, CT-102, CT-102 can discharge various somatomedin Including：PDGF-BB, epidermal growth factor, transforming growth factor-β, fibroblast growth factor, this A little somatomedin can promote granulation tissue to be formed and epithelization, accelerate ulcer healing.Current FDA Food and Drug Administration Having allowed for PDGF-BB is used for the treatment of diabetic foot wound surface.PDGF-BB price It is expensive.Epidermal growth factor is the fibroblast mitogen of dose dependent.

(9) granulocyte colony-stimulating factor (Granulocyte-colony stimulating factor, GCSF) is main The patient of diabetic foot traumatic infection is applied to, it can adjust the propagation of neutrophilic granulocyte, differentiation, ripe and be released into periphery Blood circulation, which has the disadvantage to cause high blood coagulation state, induction myocardial infarction, thrombosiss.

(10) local debridement：Diabetic foot ulcer is performance of the diabetes systemic disease in one most serious in local, Now partial cut drain, debridement dressing are extremely important, and the debridement of the debridement and surgery Other diseases of diabetic foot is that have Important difference, using " ingurgitation formula debridement " more than surgery, and the debridement contrast of diabetic foot, more using " nibbling formula Debridement ".

(11) external application Chinese medicine unguentum：Although diabetic foot method is more, most of armarium are expensive, treatment cost With it is high, uncertain therapeutic efficacy is cut, risk is big, complication is more, find in clinic safely and effectively, reasonable price, risk be low, complication is few Therapeutic Method annoying clinician always.Treatment by Chinese herbs is China's traditional medicine, its diabetic foot ulcer treat on Some superiority is highlighted, but the domestic literature report Diabetes Mellitus Treated With Traditional Chinese Medicine ulcer of foot overwhelming majority is clinical observation, its effect machine System still quotes original theory of Chinese medical science such 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, there is clear and definite evidence-based doctor The only hyperbaric oxygen and closed negative pressure for learning evidence attracts treatment, and other therapies include that various Local out dressing medicines there is no evidence-based to cure Learn evidence to support.Chinese medicine is used for treatment skin trauma always includes diabetic foot ulcer, and its mechanism is heat-clearing and toxic substances removing, promoting blood circulationization The stasis of blood and promotion wound healing.However, with regard to curative effect its evidence-based lack of evidence 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 credibility 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 combining Chinese and Western medicine there is no strict Clinical Evidence.

Although the existing Chinese medicine for the outer application of diabetic foot have certain curative effect, but it is slow to work, and the course for the treatment of is long, safety and Health giving quality is poor.

The content of the invention

In view of this, it is an object of the invention to provide a kind of Chinese medicine for outer use for treating diabetic foot ulcer, preparation Method and its application, the Chinese medicine composition have evident in efficacy, rapid-action, short treating period, safe, good effect.

The Chinese medicine for outer use of the treatment diabetic foot ulcer of the present invention, the raw material of Chinese medicine preparation is by weight including following Component：6～20 parts of the Radix Astragali, 1～10 part of Scorpio, 1～10 part of Radix Paeoniae Rubra, 3～15 parts of Rhizoma Chuanxiong, 3～15 parts of Pollen Tyjphae, Cortex Phellodendri 3～15 Part, 3～15 parts of Rhizoma Coptidis, 1～6 part of Radix Et Rhizoma Rhei, 1～7 part of Radix Angelicae Sinensis, 1～7 part of Radix Rubiae, 3～15 parts of Radix Salviae Miltiorrhizae, 25～40 parts of Gypsum Fibrosum, the Rhizoma Anemarrhenae 3～15 parts, 0.1～1 part of Borneolum Syntheticum.

Further, the raw material of Chinese medicine preparation includes following components by weight：It is 10～15 parts of the Radix Astragali, 2～6 parts of Scorpio, red 2～6 parts of Chinese herbaceous peony, 3～10 parts of Rhizoma Chuanxiong, 3～10 parts of Pollen Tyjphae, 3～10 parts of Cortex Phellodendri, 3～10 parts of Rhizoma Coptidis, 1～4 part of Radix Et Rhizoma Rhei, Radix Angelicae Sinensis 2～ 6 parts, 2～6 parts of Radix Rubiae, 3～10 parts of Radix Salviae Miltiorrhizae, 25～36 parts of Gypsum Fibrosum, 3～10 parts of the Rhizoma Anemarrhenae, 0.3～1 part of Borneolum Syntheticum.

Further, the raw material of Chinese medicine preparation includes following components by weight：12 parts of the Radix Astragali, 4 parts of Scorpio, 4 parts of Radix Paeoniae Rubra, river 6 parts of rhizome of chuanxiong, 6 parts of Pollen Tyjphae, 6 parts of Cortex Phellodendri, 6 parts of Rhizoma Coptidis, 3 parts of Radix Et Rhizoma Rhei, 4 parts of Radix Angelicae Sinensis, 4 parts of Radix Rubiae, 6 parts of Radix Salviae Miltiorrhizae, 31 parts of Gypsum Fibrosum, the Rhizoma Anemarrhenae 6 parts, 0.6 part of Borneolum Syntheticum.

Further, one or more Chinese medicine for improving or treating accompanied symptoms can be added during the Chinese medicine composition use；

Further, the Chinese medicine can add preparation made by the acceptable pharmaceutical carrier of medical science；

Further, the Chinese medicine preparation is unguentum.

Invention additionally discloses a kind of preparation method of the Chinese medicine for outer use for treating diabetic foot ulcer, including following step Suddenly：

By setting weight part by the Radix Astragali, Scorpio, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Pollen Tyjphae, Cortex Phellodendri, Rhizoma Coptidis, Radix Et Rhizoma Rhei, Radix Angelicae Sinensis, Radix Rubiae, pellet Ginseng, the Rhizoma Anemarrhenae, Borneolum Syntheticum are decocted after soaking in adding Oleum Sesami to slightly bitter, then sequentially add absolute oil and white vinegar and Cera Flava stirring Cool down after dissolving to melting, be eventually adding finely ground Gypsum Fibrosum, stir, be cooled to cream；

Further, by setting weight part by the Radix Astragali, Scorpio, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Pollen Tyjphae, Cortex Phellodendri, Rhizoma Coptidis, Radix Et Rhizoma Rhei, Radix Angelicae Sinensis, Radix Rubiae, Radix Salviae Miltiorrhizae, the Rhizoma Anemarrhenae, Borneolum Syntheticum are soaked 3-8 days in adding Oleum Sesami；

Further, soak 6 days in Oleum Sesami.

Further, application of the Chinese medicine for outer use in the medicine for preparing diabetic foot ulcer.

Beneficial effects of the present invention：The treatment Chinese medicine for outer use of diabetic foot ulcer of the present invention, preparation method and its Using Sanguis Draxonis are sweet salty flat for property, the function with promoting blood circulation to remove blood stasis pain relieving, convergence granulation promoting, have antifungal to act on.Olibanum, Myrrha, Resinous, volatile oil, has preferable blood circulation promoting and blood stasis dispelling, Repercusion analgesia, promoting pus discharge and tissue regeneration strengthening effect.

Gypsum Fibrosum, property are sweet, pungent, puckery, cold, have the effect of removing dampness granulation promoting, sore and stop blooding, can suppress antibacterial, especially to golden yellow Staphylococcuses, bacillus pyocyaneus are sensitive, and Gypsum Fibrosum also has heat clearing away, analgesic activity, has dilating effect to tip blood capillary, can promote The blood circulation of local.Rhizoma Coptidis, heat-clearing and toxic substances removing, blood sugar lowering, antibacterial.Radix Salviae Miltiorrhizae, blood circulation promoting and blood stasis dispelling, cool blood to disappear carbuncle, tissue regeneration promoting blood go to dislike Blood.The Radix Astragali and Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae synergism, promote diabrosis and limitation effect, while accelerate skin ulcer face promoting tissue regeneration and wound healing, it is also sharp In regulation blood glucose.The effect of Scorpio, mild-natured, acrid in the mouth, poisonous, return liver warp, tool endogenous wind stopping spasmolytic, dispersing pathogen accumulation, removing obstruction in the collateral to relieve pain.Ice Piece, cool in nature, acrid in the mouth are bitter, GUIXIN, lung meridian, have the effect of leading to all keys, dissipate stagnated fire, removing nebula improving eyesight, reducing swelling and alleviating pain, and its perfume (or spice) is walked to alter, deep Enter space between skin and muscles, penetration is strong, and the absorption of effective ingredient, long duration of action can be promoted transdermal effect to be reached in affected part.Radix Paeoniae Rubra, taste Hardship, cold nature, purify the blood a point excess-heat, and scattered blood stasis are detained.Pollen Tyjphae, cooling blood for hemostasis, blood circulation promoting and blood stasis dispelling improve local circulation, promote weight Absorb and reduce the permeability of blood capillary.Cortex Phellodendri, Cortex Phellodendri have the power of heat clearing and damp drying, similar to Radix Scutellariae, Rhizoma Coptidis, but with except lower Jiao It is damp and hot be preferred, angiogenesiss can be effectively promoted, diminish inflammation edema, improves microcirculation, promotes wound healing and granulation group Knit generation.Radix Et Rhizoma Rhei, with purging heat and dredging bowels, removing pathogenic heat from blood and toxic substance from the body, effect of eliminating blood stasis and inducing menstruation.Radix Rubiae, removing heat from blood and promoting blood circulation, blood stasis dispelling.The Rhizoma Anemarrhenae, can promote Enter the intake of diaphragm, fatty tissue to glucose, glycogen content slightly increases in making diaphragm.Oil and white vinegar as organic solvent, Due to dissolving the effective ingredient in Chinese medicine.Cera Flava makes paste after can making preparation cooling as plastotype agent.

Synergism between said components material, with Radix Astragali Scorpio as monarch drug, with Radix Paeoniae Rubra Rhizoma Chuanxiong Pollen Tyjphae Radix Salviae Miltiorrhizae as ministerial drug, with Cortex Phellodendri Rhizoma Coptidis Radix Et Rhizoma Rhei is adjuvant drug, with Radix Rubiae Gypsum Fibrosum Rhizoma Anemarrhenae Borneolum Syntheticum to make medicine, each component reasonable preparation play blood circulation promoting and blood stasis dispelling altogether, is subsided a swelling Granulation promoting, the work(of heat-clearing and toxic substances removing evacuation of pus, so that stagnation resolvation network is logical, acra normal circulation of qi and blood, muscle nutrition are sufficient, and the skin ulcer meat that disappears is long, effectively Cure the ulcer of foot that diabetes cause, by heat-clearing and toxic substances removing, make the blood vessel of whole body recover elasticity, by original blood supply insufficiency to tending to Normal slow process, the Gene regulation element and effective active molecule in raw material of Chinese medicine enter blood, and go directly diseased region, flat During steady regulation, based on nourishing liver and kidney, the impaired histoorgan of human body is repaired, the pathogenesis of diabetes are progressively controlled, Nerve system of human body is adjusted, blood circulation promoting plays coordination and Comprehensive Treatment function, and fundamentally thoroughly reverting diabetes are sent out Pathogenesis system, makes body reach rehabilitation；Putrefaction-removing granulation-promoting, promoting the flow of QI-blood by warming the meridian, benefiting QI for activating blood circulation) mitigate limb pain, the infection of control skin ulcer face changes Kind local microcirculation, strengthens the two-way transhipment function of endotheliocyte, improves perineural conduction velocity, promotion organization reparation and The healing of wound surface.

Specific embodiment

The Chinese medicine for outer use of the treatment diabetic foot ulcer of the present embodiment, the raw material of Chinese medicine preparation include by weight with Lower component：6～20 parts of the Radix Astragali, 1～10 part of Scorpio, 1～10 part of Radix Paeoniae Rubra, 3～15 parts of Rhizoma Chuanxiong, 3～15 parts of Pollen Tyjphae, Cortex Phellodendri 3～ 15 parts, 3～15 parts of Rhizoma Coptidis, 1～6 part of Radix Et Rhizoma Rhei, 1～7 part of Radix Angelicae Sinensis, 1～7 part of Radix Rubiae, 3～15 parts of Radix Salviae Miltiorrhizae, 25～40 parts of Gypsum Fibrosum, know Female 3～15 parts, 0.1～1 part of Borneolum Syntheticum.

In the present embodiment, the raw material of Chinese medicine preparation includes following components by weight：10～15 parts of the Radix Astragali, Scorpio 2～6 Part, 2～6 parts of Radix Paeoniae Rubra, 3～10 parts of Rhizoma Chuanxiong, 3～10 parts of Pollen Tyjphae, 3～10 parts of Cortex Phellodendri, 3～10 parts of Rhizoma Coptidis, 1～4 part of Radix Et Rhizoma Rhei, when Return 2～6 parts, 2～6 parts of Radix Rubiae, 3～10 parts of Radix Salviae Miltiorrhizae, 25～36 parts of Gypsum Fibrosum, 3～10 parts of the Rhizoma Anemarrhenae, 0.3～1 part of Borneolum Syntheticum.

In the present embodiment, the raw material of Chinese medicine preparation includes following components by weight：12 parts of the Radix Astragali, 4 parts of Scorpio, Radix Paeoniae Rubra 4 Part, 6 parts of Rhizoma Chuanxiong, 6 parts of Pollen Tyjphae, 6 parts of Cortex Phellodendri, 6 parts of Rhizoma Coptidis, 3 parts of Radix Et Rhizoma Rhei, 4 parts of Radix Angelicae Sinensis, 4 parts of Radix Rubiae, 6 parts of Radix Salviae Miltiorrhizae, Gypsum Fibrosum 31 Part, 6 parts of the Rhizoma Anemarrhenae, 0.6 part of Borneolum Syntheticum.

In the present embodiment, one or more can be added during the Chinese medicine composition use for improving or treating in accompanied symptoms Medicine.

In the present embodiment, the Chinese medicine can add preparation made by the acceptable pharmaceutical carrier of medical science.

In the present embodiment, the Chinese medicine preparation is unguentum.

The preparation method of the Chinese medicine for outer use of the treatment diabetic foot ulcer of the present embodiment, comprises the following steps：

By setting weight part by the Radix Astragali, Scorpio, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Pollen Tyjphae, Cortex Phellodendri, Rhizoma Coptidis, Radix Et Rhizoma Rhei, Radix Angelicae Sinensis, Radix Rubiae, pellet Ginseng, the Rhizoma Anemarrhenae, Borneolum Syntheticum are decocted after soaking in adding Oleum Sesami to slightly bitter, then sequentially add absolute oil and white vinegar and Cera Flava stirring Cool down after dissolving to melting, be eventually adding finely ground Gypsum Fibrosum, stir, be cooled to cream.

In the present embodiment, by setting weight part by the Radix Astragali, Scorpio, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Pollen Tyjphae, Cortex Phellodendri, Rhizoma Coptidis, Radix Et Rhizoma Rhei, when Return, Radix Rubiae, Radix Salviae Miltiorrhizae, the Rhizoma Anemarrhenae, Borneolum Syntheticum add Oleum Sesami in soak 3-8 days.

In the present embodiment, soak 6 days in Oleum Sesami.

In the present embodiment, application of the Chinese medicine for outer use in the medicine for preparing diabetic foot ulcer.

The Chinese medicine composition of the present invention is further elaborated below by specific embodiment：

Embodiment one

The Chinese medicine for outer use of the treatment diabetic foot ulcer of the present embodiment, the raw material of Chinese medicine preparation include by weight with Lower component：12 parts of the Radix Astragali, 4 parts of Scorpio, 4 parts of Radix Paeoniae Rubra, 6 parts of Rhizoma Chuanxiong, 6 parts of Pollen Tyjphae, 6 parts of Cortex Phellodendri, 6 parts of Rhizoma Coptidis, 3 parts of Radix Et Rhizoma Rhei, when Return 4 parts, 4 parts of Radix Rubiae, 6 parts of Radix Salviae Miltiorrhizae, 31 parts of Gypsum Fibrosum, 6 parts of the Rhizoma Anemarrhenae, 0.6 part of Borneolum Syntheticum.

By the Radix Astragali, Scorpio, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Pollen Tyjphae, Cortex Phellodendri, Rhizoma Coptidis, Radix Et Rhizoma Rhei, Radix Angelicae Sinensis, Radix Rubiae, Radix Salviae Miltiorrhizae, the Rhizoma Anemarrhenae, Borneolum Syntheticum Decoct to slightly bitter after soaking 6 days in adding Oleum Sesami, then sequentially add absolute oil and white vinegar and Cera Flava stirs molten to melting Cool down after solution, be eventually adding finely ground Gypsum Fibrosum, stir, be cooled to cream.

Embodiment two

The Chinese medicine for outer use of the treatment diabetic foot ulcer of the present embodiment, the raw material of Chinese medicine preparation include by weight with Lower component：6 parts of the Radix Astragali, 1 part of Scorpio, 1 part of Radix Paeoniae Rubra, 3 parts of Rhizoma Chuanxiong, 3 parts of Pollen Tyjphae, 3 parts of Cortex Phellodendri, 3 parts of Rhizoma Coptidis, 1 part of Radix Et Rhizoma Rhei, Radix Angelicae Sinensis 1 part, 1 part of Radix Rubiae, 3 parts of Radix Salviae Miltiorrhizae, 25 parts of Gypsum Fibrosum, 3 parts of the Rhizoma Anemarrhenae, 0.1 part of Borneolum Syntheticum.

By the Radix Astragali, Scorpio, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Pollen Tyjphae, Cortex Phellodendri, Rhizoma Coptidis, Radix Et Rhizoma Rhei, Radix Angelicae Sinensis, Radix Rubiae, Radix Salviae Miltiorrhizae, the Rhizoma Anemarrhenae, Borneolum Syntheticum Decoct to slightly bitter after soaking 3 days in adding Oleum Sesami, then sequentially add absolute oil and white vinegar and Cera Flava stirs molten to melting Cool down after solution, be eventually adding finely ground Gypsum Fibrosum, stir, be cooled to cream.

Embodiment three

The Chinese medicine for outer use of the treatment diabetic foot ulcer of the present embodiment, the raw material of Chinese medicine preparation include by weight with Lower component：20 parts of the Radix Astragali, 10 parts of Scorpio, 10 parts of Radix Paeoniae Rubra, 15 parts of Rhizoma Chuanxiong, 15 parts of Pollen Tyjphae, 15 parts of Cortex Phellodendri, 15 parts of Rhizoma Coptidis, Radix Et Rhizoma Rhei 6 Part, 7 parts of Radix Angelicae Sinensis, 7 parts of Radix Rubiae, 15 parts of Radix Salviae Miltiorrhizae, 40 parts of Gypsum Fibrosum, 15 parts of the Rhizoma Anemarrhenae, 1 part of Borneolum Syntheticum.

By the Radix Astragali, Scorpio, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Pollen Tyjphae, Cortex Phellodendri, Rhizoma Coptidis, Radix Et Rhizoma Rhei, Radix Angelicae Sinensis, Radix Rubiae, Radix Salviae Miltiorrhizae, the Rhizoma Anemarrhenae, Borneolum Syntheticum Decoct to slightly bitter after soaking 8 days in adding Oleum Sesami, then sequentially add absolute oil and white vinegar and Cera Flava stirs molten to melting Cool down after solution, be eventually adding finely ground Gypsum Fibrosum, stir, be cooled to cream.

Example IV

The Chinese medicine for outer use of the treatment diabetic foot ulcer of the present embodiment, the raw material of Chinese medicine preparation include by weight with Lower component：10 parts of the Radix Astragali, 2 parts of Scorpio, 2 parts of Radix Paeoniae Rubra, 3 parts of Rhizoma Chuanxiong, 3 parts of Pollen Tyjphae, 3 parts of Cortex Phellodendri, 3 parts of Rhizoma Coptidis, 1 part of Radix Et Rhizoma Rhei, when Return 2 parts, 2 parts of Radix Rubiae, 3 parts of Radix Salviae Miltiorrhizae, 25 parts of Gypsum Fibrosum, 3 parts of the Rhizoma Anemarrhenae, 0.3 part of Borneolum Syntheticum.

By the Radix Astragali, Scorpio, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Pollen Tyjphae, Cortex Phellodendri, Rhizoma Coptidis, Radix Et Rhizoma Rhei, Radix Angelicae Sinensis, Radix Rubiae, Radix Salviae Miltiorrhizae, the Rhizoma Anemarrhenae, Borneolum Syntheticum Decoct to slightly bitter after soaking 4 days in adding Oleum Sesami, then sequentially add absolute oil and white vinegar and Cera Flava stirs molten to melting Cool down after solution, be eventually adding finely ground Gypsum Fibrosum, stir, be cooled to cream.

Embodiment five

The Chinese medicine for outer use of the treatment diabetic foot ulcer of the present embodiment, the raw material of Chinese medicine preparation include by weight with Lower component：15 parts of the Radix Astragali, 6 parts of Scorpio, 6 parts of Radix Paeoniae Rubra, 10 parts of Rhizoma Chuanxiong, 10 parts of Pollen Tyjphae, 10 parts of Cortex Phellodendri, 10 parts of Rhizoma Coptidis, Radix Et Rhizoma Rhei 4 Part, 6 parts of Radix Angelicae Sinensis, 6 parts of Radix Rubiae, 10 parts of Radix Salviae Miltiorrhizae, 36 parts of Gypsum Fibrosum, 10 parts of the Rhizoma Anemarrhenae, 1 part of Borneolum Syntheticum.

By the Radix Astragali, Scorpio, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Pollen Tyjphae, Cortex Phellodendri, Rhizoma Coptidis, Radix Et Rhizoma Rhei, Radix Angelicae Sinensis, Radix Rubiae, Radix Salviae Miltiorrhizae, the Rhizoma Anemarrhenae, Borneolum Syntheticum Decoct to slightly bitter after soaking 7 days in adding Oleum Sesami, then sequentially add absolute oil and white vinegar and Cera Flava stirs molten to melting Cool down after solution, be eventually adding finely ground Gypsum Fibrosum, stir, be cooled to cream.

Embodiment six

The raw material of Chinese medicine preparation includes following components by weight：18 parts of the Radix Astragali, 10 parts of Scorpio, 5 parts of Radix Paeoniae Rubra, 3 parts of Rhizoma Chuanxiong, 15 parts of Pollen Tyjphae, 8 parts of Cortex Phellodendri, 8 parts of Rhizoma Coptidis, 6 parts of Radix Et Rhizoma Rhei, 1 part of Radix Angelicae Sinensis, 3 parts of Radix Rubiae, 12 parts of Radix Salviae Miltiorrhizae, 25 parts of Gypsum Fibrosum, the Rhizoma Anemarrhenae 15 Part, 0.8 part of Borneolum Syntheticum.

The preparation method of the embodiment is with embodiment one.

Embodiment seven

The raw material of Chinese medicine preparation includes following components by weight：10 parts of the Radix Astragali, 5 parts of Scorpio, 3 parts of Radix Paeoniae Rubra, 5 parts of Rhizoma Chuanxiong, 3 parts of Pollen Tyjphae, 10 parts of Cortex Phellodendri, 5 parts of Rhizoma Coptidis, 1 part of Radix Et Rhizoma Rhei, 6 parts of Radix Angelicae Sinensis, 6 parts of Radix Rubiae, 8 parts of Radix Salviae Miltiorrhizae, 28 parts of Gypsum Fibrosum, 10 parts of the Rhizoma Anemarrhenae, 0.3 part of Borneolum Syntheticum.

The preparation method of the embodiment is with embodiment two.

The Chinese medicine for outer use of the treatment diabetic foot ulcer of above-described embodiment, can not only make paste, can also add Enter the acceptable carrier of medical science and make preparation, liquid lotion is made by pharmaceutical carrier such as, affected part is cleaned, Or powder powder is spread at wound, preferably ointment dosage form certainly, these can adopt existing commercial process Can realize.Using when, in the case where this Chinese medicine composition effect is not affected, one or more can be added for improving or control The Chinese medicine of accompanied symptoms is treated, for example：The wet Inner of deficiency of spleen-YANG and kidneyYANG, water stops caused edema, the Rhizoma Atractylodis Macrocephalae, Poria, Rhizoma Alismatis, Semen Plantaginiss tonneau urine； The cold gas of Rhizoma Zingiberis Recenss temperature aproll；Radix Achyranthis Bidentatae priming is descending, strong waist and knee；If cardiopalmus, lip dark purple, deficient and rapid pulse or knot generation, be pathogenic water superinverse, become silted up Stop in blood, benefit reuses Radix Aconiti Lateralis Preparata, failure of the kidney in receiving QI reuses Radix Ginseng, Gecko, Fructus Schisandrae Chinensis, Fructus Corni, Concha Ostreae, Os Draconis, in case collapse syndrome caused by dyspnea；It is dizzy It is dizzy：Mantidiss, 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, volt Refreshing tranquilizing by nourishing the heart.The deficiency of YIN more notably adds Radix Rehmanniae, Radix Scrophulariae, Poria cum Radix Pini, Caulis Polygoni Multiflori, plus Radix Polygalae, Semen Ziziphi Spinosae (parched), honey-fried BULBUS LILII to pacify with nourishing heart God；If seeing, dizziness is intended to fall forward, vomiting and nausea, numb hand and foot or the sound that trembles, the gesture for having the dynamic wind-transformation of sun, plus Concha Margaritifera, Os Draconis, Concha Ostreae, The product of the town such as Cornu Saigae Tataricae liver endogenous wind stopping.Stranguria：Semen Plantaginiss, Herba Polygoni Avicularis, Herba Dianthi in side, Talcum is treating stranguria dampness removing.Addition Radix Glycyrrhizae can be with emergency Pain relieving.

Clinical experiment example

To chronic sugar between the contrast quasi- surgical intervention of 1 Chinese medicinal ointment mark-on of the embodiment of the present invention and the treatment of simple Standard surgical The effectiveness of urine foot disease ulcer and safety are evaluated.

Inclusive criteria：(1) diabeticss (1 type or 2 types)；(2) age 18 years old to 85 years old；(3) diabetic foot ulcer It is classified as Wagner classification 1-3 levels；(4) diabetic duration more than 5 years, ulcer of foot is more than 12 weeks；(5) can and be ready to know the inside story Agree to；(6) patient 0.7≤ABI≤1.2, and/or suffer from sufficient doppler waveform for two phase waves or triphasic wave.

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 treatment and follow-up person can not be participated in mental sickness；(5) the severe primary disease for merging life-threatening is for example pernicious Tumor, disease in the blood system, HIV positives；(6) it is associated with serious malnutrition or has hemorrhage 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 classification), laboratory inspection Survey index (blood glucose, routine blood test, 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 merging deep infection or systemic infection symptom such as heating, blood leukocytes allows to make when rising high Use antibiotic.

Efficacy evaluation:Main effectively endpoints：The healing completely of ulcer and the improvement of ulcer.The healing completely of ulcer is fixed Justice is covered by epithelial cell for ulcer surface 100%, and nothing is oozed out, it is not required that dressing change.The improvement of ulcer is defined as ulcer Wagner classifications reduce more than 1 rank (including 1 rank) and/or ulcer area reduced for more than 50% (including 50%).It is secondary Want effective endpoints：The constituent and healing time that ulcer improves is defined as secondary endpoints event.

Escape mechanism：(1) patient's refusal is further treated using which；(2) diabetes mellitus' ulcer of foot deteriorates, Expectant treatment cannot be continued, the meddlers such as surgical amputation (toe) are needed；(3) patient's ordinary circumstance deteriorates, and pyemia, dead occurs The severe complication etc. such as die.

Therapeutic Method：, without the eluting phase, the patient after including is immediately according to 1 for all patients for including:1 pro rate is extremely Different treatment groups receive Standard surgical treatment (matched group) and Standard surgical treatment plus the external for the treatment of diabetic foot ulcer respectively Chinese medicine preparation treatment (treatment group).The Chinese medicine for outer use for treating diabetic foot ulcer is applied in skin surface by treatment group, with Ulcer depth is with high.According to actual needs or the suggestion of expert group determines dressing time, general interval 1 to 3 days, until ulcer is complete Full healing (ulcer of 24 week observation period healing) or full 24 week observation period (ulcer not healed in 24 week observation period).For ulcer The patient of healing, 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 matched group (29), treatment according to randomizing scheme After 24 weeks, ulcer improvement rate (treatment group's vs. matched groups) is in 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 it is effective in Matched group, points out the Chinese medicine for outer use treatment group of the treatment diabetic foot ulcer of the present invention to be significantly better than in terms of ulcer improvement Standard surgical treatment group.The clinical trial of this project confirms the Chinese medicine for outer use of the treatment diabetic foot ulcer of the present invention to chronic The potential efficacy and saferry of diabetic foot ulcer, points out the Chinese medicine for outer use for the treatment of diabetic foot ulcer can speed up chronic The Healing Rate of diabetic foot ulcer.

Safety:Compared with Western medicine, the toxic and side effects of Chinese medicine and untoward 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 section of China of Guizhou Province The expert of natural product chemistry key lab of institute instructs and completes.And detect wherein big using high performance liquid chromatography (HPLC) The concentration of flavin and chrysophanol.Every batch of sample must carry out Hygienic determination, as long as the sample for reaching sterility requirements can be permitted Perhaps enter Clinical practice.In this research follow-up period of 6 months, there is not disease in the blood system, liver function injury, kidney work(in patient Can the side reaction such as infringement and skin allergy.Although there is the generation (each 2) of wound surface pain events, its incidence rate is controlled two Between treatment group, there was no significant difference.The Chinese medicine composition of this explanation present invention has reliable peace in terms for the treatment of diabetic foot ulcer 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 it is contained to Rhizoma Coptidis, Radix Et Rhizoma Rhei etc. into Dividing carries out identification experiment, and the active ingredient emodin in unguentum, chrysophanol are determined using high performance liquid chromatography (HPLC) method Content.

The Chinese medicine composition Hygienic determination method of the present invention:Antibacterial life is whether there is in 12 planted culture dishs of observation It is long.Do not send out Jing after the Hygienic determination according to above method from on-test to the medicine for terminating all entrance Clinical practices Existing bacterial growth.

This research adopts evidence-based medicine EBM the system evaluation safety 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.By clinic Test confirms that sugared sufficient infectionss Chinese medicine composition of healing, to the potential efficacy and saferry of chronic diabetes ulcer of foot, points out sugar foot more infectionss 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, are to mitigate the ailing of patient with diabetic feet and mitigate the work that medical burden has made initiative.

Model case

1. an XX, female, 68 years old.Main suit suffers from diabetes 20 years, and left foot toe is first numb, afterwards pain, blue about as long as half a year, toe Nigrescence ulceration 4 days, eats antalgica and antibiotic medicine effect on driving birds is not good.Have a medical check-up：The equal ulceration of bipod skin of toe after left foot.Lab testing： Fasting glucose 9.2mmol/L.Patient requests' external Chinese medicine of the present invention, the basic alleviating pain in 5 or so days, numbness；Wound after 14 days Healing, incrustation, and guide patient to be careful in one's diet, glucose-lowering treatment on time, and clinical symptoms are wholly absent, and after half a year, follow-up is multiple again Send out.

2. Lee XX, male, 68 years old.Main suit suffers from diabetes 25 years, informal dress Or Metformin In Treating diabetes, toe pain 2 still occurs Individual month, blue more than 10 day of skin increased 3 days, antibiotic therapy 10 days, effect on driving birds is not good.Have a medical check-up：Biped toe skin is blue, left 2 toe skin darkening of side.Lab testing：Fasting glucose 8.7mmol/L.Patient requests' external Chinese medicine of the present invention 10 days, toe Erythrosises moisten, and and guide diet, continue glucose-lowering treatment, and clinical symptoms are wholly absent, do not recur again.

3. grandson's ××, male, 70 years old, diabetic history 20 years, and sky takes blood glucose 14mnol/l, urine examination ++, left lower extremity ulcer gangrene 3 Year, it is numb around ulcer, to feel to go down, have hospital's suggestion amputation, by oral administration hypoglycemic medicine, glycemic control is left in 6.5mnol/l The right side, afterwards using Chinese medicine of the present invention, by paste application of the present invention is in wound surface and pours into sinus tract after the debridement of local, dressing on the one once, Wound surface purulent secretion is significantly reduced, and after 14 days, wound surface starts incrustation, sinus tract closure, wound healing after 30 days.

Finally illustrate, above example is only unrestricted to illustrate technical scheme, although with reference to compared with Good embodiment has been described in detail to the present invention, it will be understood by those within the art that, can be to the skill of the present invention Art scheme is modified or equivalent, and without deviating from the objective and scope of technical solution of the present invention, which all should be covered at this In the middle of the right of invention.

Claims (9)

1. a kind of Chinese medicine for outer use for treating diabetic foot ulcer, it is characterised in that：The raw material of Chinese medicine preparation by weight by Following components is constituted：6～20 parts of the Radix Astragali, 1～10 part of Scorpio, 1～10 part of Radix Paeoniae Rubra, 3～15 parts of Rhizoma Chuanxiong, 3～15 parts of Pollen Tyjphae, Huang 3～15 parts of cypress, 3～15 parts of Rhizoma Coptidis, 1～6 part of Radix Et Rhizoma Rhei, 1～7 part of Radix Angelicae Sinensis, 1～7 part of Radix Rubiae, 3～15 parts of Radix Salviae Miltiorrhizae, Gypsum Fibrosum 25～40 Part, 3～15 parts of the Rhizoma Anemarrhenae, 0.1～1 part of Borneolum Syntheticum.

2. it is according to claim 1 treatment diabetic foot ulcer Chinese medicine for outer use, it is characterised in that：Chinese medicine preparation Raw material is composed of the following components by weight：10～15 parts of the Radix Astragali, 2～6 parts of Scorpio, 2～6 parts of Radix Paeoniae Rubra, 3～10 parts of Rhizoma Chuanxiong, life 3～10 parts of Pollen Typhae, 3～10 parts of Cortex Phellodendri, 3～10 parts of Rhizoma Coptidis, 1～4 part of Radix Et Rhizoma Rhei, 2～6 parts of Radix Angelicae Sinensis, 2～6 parts of Radix Rubiae, Radix Salviae Miltiorrhizae 3～ 10 parts, 25～36 parts of Gypsum Fibrosum, 3～10 parts of the Rhizoma Anemarrhenae, 0.3～1 part of Borneolum Syntheticum.

3. it is according to claim 2 treatment diabetic foot ulcer Chinese medicine for outer use, it is characterised in that：Chinese medicine preparation Raw material is composed of the following components by weight：12 parts of the Radix Astragali, 4 parts of Scorpio, 4 parts of Radix Paeoniae Rubra, 6 parts of Rhizoma Chuanxiong, 6 parts of Pollen Tyjphae, Cortex Phellodendri 6 Part, 6 parts of Rhizoma Coptidis, 3 parts of Radix Et Rhizoma Rhei, 4 parts of Radix Angelicae Sinensis, 4 parts of Radix Rubiae, 6 parts of Radix Salviae Miltiorrhizae, 31 parts of Gypsum Fibrosum, 6 parts of the Rhizoma Anemarrhenae, 0.6 part of Borneolum Syntheticum.

4. according to claim 1-3 any claim treatment diabetic foot ulcer Chinese medicine for outer use, its feature It is：The Chinese medicine can add the acceptable pharmaceutical carrier of medical science to make preparation.

5. it is according to claim 4 treatment diabetic foot ulcer Chinese medicine for outer use, it is characterised in that：The Chinese medicine system Agent is unguentum.

6. described in a kind of claim 1 treatment diabetic foot ulcer Chinese medicine for outer use preparation method, it is characterised in that： Comprise the following steps：

By setting weight part by the Radix Astragali, Scorpio, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Pollen Tyjphae, Cortex Phellodendri, Rhizoma Coptidis, Radix Et Rhizoma Rhei, Radix Angelicae Sinensis, Radix Rubiae, Radix Salviae Miltiorrhizae, know Female, Borneolum Syntheticum is decocted after soaking in adding Oleum Sesami to slightly bitter, then sequentially adds absolute oil and white vinegar and Cera Flava is stirred to melting Cool down after changing dissolving, be eventually adding finely ground Gypsum Fibrosum, stir, be cooled to cream.

7. it is according to claim 6 treatment diabetic foot ulcer Chinese medicine for outer use preparation method, it is characterised in that： By setting weight part by the Radix Astragali, Scorpio, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Pollen Tyjphae, Cortex Phellodendri, Rhizoma Coptidis, Radix Et Rhizoma Rhei, Radix Angelicae Sinensis, Radix Rubiae, Radix Salviae Miltiorrhizae, the Rhizoma Anemarrhenae, Borneolum Syntheticum is soaked 3-8 days in adding Oleum Sesami.

8. it is according to claim 7 treatment diabetic foot ulcer Chinese medicine for outer use preparation method, it is characterised in that： Soak 6 days in Oleum Sesami.

9. a kind of Chinese medicine for outer use of the treatment diabetic foot ulcer described in claim 1-3 any claim is preparing sugar Application in the medicine of urine foot disease ulcer.