CN115554354B - Chinese medicinal preparation for treating diabetic foot ulcer and preparation method thereof - Google Patents

Abstract

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine preparation for treating diabetic foot ulcers and a preparation method thereof, wherein the traditional Chinese medicine preparation comprises the following components: angelica sinensis, radix rehmanniae, crinis Carbonisatus, lithospermum, dragon's blood, tortoise plastron, cuttlebone, gypsum, calamine and auxiliary materials such as yellow wax, white wax and sesame oil; taking sesame oil, putting the sesame oil into a pot, taking residual blood charcoal, and putting the residual blood charcoal into the pot; taking out the crinis Carbonisatus, grinding into fine powder, and making into paste to obtain crinis Carbonisatus paste; taking tortoise plastron, putting the tortoise plastron into a fragrant oil pot, boiling the tortoise plastron into chestnut skin color, adding sesame oil, taking the raw rehmannia root, boiling the raw rehmannia root into scorched color, adding Chinese angelica and lithospermum till the raw materials are boiled, filtering and removing dregs, and boiling with slow fire; adding oleum Sesami, galamina, gypsum Fibrosum, and Os Sepiae, and decocting with slow fire; taking the pot, decocting the yellow wax and the white wax until no foam exists, filtering the materials in the sesame oil pot by using gauze, and extinguishing the fire after the materials are boiled; stirring to slightly lower temperature, adding sanguis Draxonis and residual paste, and stirring to obtain paste. The traditional Chinese medicine preparation is used for treating diabetic foot ulcers, has remarkable curative effect and low raw material cost, and has a simple preparation method and great popularization value.

Description

Chinese medicinal preparation for treating diabetic foot ulcer and preparation method thereof

Technical Field

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine preparation for treating diabetic foot ulcers and a preparation method thereof.

Background

Diabetic foot ulcers (diabetic foot ulcer, DFU) are a common complication of diabetes, DFU is a small and medium blood vessel and microcirculation disturbance of lower limbs of diabetics, foot ulcers, infections and even gangrene caused by peripheral neuropathy or concurrent infections, and is one of important causes of disability and even death of diabetics, which not only causes pain to patients, but also brings great economic burden to families of patients, and great medical expenditure caused by DFU is also a cause of great public health problem of social burden.

DFU pathogenesis is mainly that along with the continuous rise of blood sugar level, the long-time blood sugar control in human body is poor, resulting in impaired islet function, reduced synthesis of adenine nucleoside triphosphate (ATP), reduced insulin secretion, resulting in the rise of blood sugar and blood lipid in human body, high concentration of blood sugar and blood lipid level can inhibit mitochondrial electron transfer chain, resulting in mitochondrial oxidative stress injury, vascular endothelial injury and narrowing of vascular cavity, resulting in ischemia and influencing neovascularization, and reduced immunity to infection. The disease is easy to cure for a long time, infection occurs, and a plurality of influencing factors of osteomyelitis and bone destruction are caused, wherein diabetes nephropathy, peripheral neuropathy (DPN), autonomic neuropathy, lower limb atherosclerosis (LEAD) and the like are dangerous factors of occurrence of diabetic feet; the advanced age, long disease course, poor blood sugar control, infection degree, general nutrition condition, DPN, lower limb arterial ischemia and the like of patients are important reasons for causing the unhealed ulcer and amputation; DPN, LEAD, etc. associated with poor smoking, glycemic control, and loss of ankle reflex are important independent risk factors for recurrence of foot ulcers; dialysis treatment and poor glycemic control are independent predictors of the recurrence of critical limb ischemia following intravascular treatment. And the clinical recurrence of severe acute limb ischemia is closely related to recurrence of foot ulcer, large amputation and even increased death rate, mistreatment of diabetic foot loss, poor prognosis and the like.

DFU appears clinically as both neuropathy and lower limb ischemia. Neuropathy is manifested as: if the skin of the affected limb is dry and has no sweat, the limb end is stabbed, causalgia, numbness, hypoesthesia or loss, the sock is changed, and the foot is treaded to form a cotton feeling during walking; ischemia of the lower extremities is manifested as: skin malnutrition, muscular atrophy, dry skin, poor elasticity, skin temperature drop, pigmentation, attenuation or disappearance of arterial pulsation at extremities, and patients with intermittent claudication of lower extremities can be combined. With the progress of the lesions, resting pain may occur, gangrene may occur at the toe end, ulcers may occur at the pressed areas of the heel or metatarsophalangeal joints, and some patients may have limb infections.

The purpose of treating DFU is to promote ulcer healing, reduce amputation rate, protect limb function, more importantly reduce cardiovascular and cerebrovascular events, reduce death rate, prolong life time of patients and improve life quality of patients.

At present, aiming at the DFU treatment means, besides effective blood sugar monitoring control and debridement, drug treatment exists, and western medicine treatment currently takes alpha-zinc sulfate as a main treatment drug. The alpha-zinc sulfate makes insulin more sensitive to act on human body, thereby promoting the absorption of glucose by targeted tissues and controlling blood sugar to reach a stable state; meanwhile, the nerve cells are protected, the incidence rate of the nerve disorder is reduced, oxidative stress caused by hyperglycemia is avoided to damage nerve growth factors, and numbness or spontaneous pain is relieved. However, the medicine can only temporarily relieve symptoms, does not play a role in treatment aiming at etiology, and has the characteristics of more toxic and side effects, increased drug resistance, strong dependence and the like. In the DFU treatment technology, the medicine for supplementing qi, activating blood, removing stasis and eliminating dampness is far from being convenient and quick in curative effect compared with external application, and has strong targeting and obvious effect.

Amputation surgical treatments in existing diabetic foot ulcer surgical treatment techniques include small-range amputation and large-range amputation. The small-range amputation includes amputation, plantar column excision and partial foot amputation, and the large-range amputation includes shank amputation, knee joint amputation and thigh amputation. The amputation surgery treatment definitely causes great impact on the daily life of the patient, and the reduction of the life quality not only brings serious impact and economic burden to the family of the patient, but also brings serious social and economic burden. The average cost of DFU hospitalized patients in 14 hospitals such as the third class a in 2004 was about 15000 yuan, which is about 4 times the average cost of diabetes hospitalized patients. In addition, the diabetic foot ulcer operation treatment technology also has minimally invasive operations such as lower limb artery interventional treatment, vascular reconstruction and the like, the operation treatment difficulty coefficient is large, the risk is high, postoperative complications such as hematoma, pseudoaneurysm, infection, lower limb distal tissue edema, acute lower limb arterial thrombosis and the like are more numerous, and old and weak people often cannot be subjected to the operation. Therefore, the existing treatment technical means have the defects of difficult cure, high cost, high disability rate and high amputation rate, seriously influence the life quality and survival pressure of patients, bring great economic difficulty to the patients and bring great psychological huge simultaneously.

The prior art topical adjuvant treatments include: novel dressing, growth factor, negative pressure closed drainage technology, skin regeneration medical technology, hyperbaric oxygen treatment and the like, and have the defects of unstable treatment effect, long treatment period, high cost, high recurrence rate and the like. Some of the formulas for treating diabetic foot by adopting the traditional Chinese medicine composition in the prior art are as follows:

CN101716248A discloses a traditional Chinese medicine composition for treating diabetic foot, which consists of active ingredients and pharmaceutically acceptable carriers, wherein the active ingredients are prepared from the following raw materials in parts by weight: bamboo fungus 5, cinnamon 8, gardenia 20, black-tail snake 25, sea buckthorn 25, angelica dahurica 15 and citron 10.

CN101926872a discloses a traditional Chinese medicine detoxification and granulation promoting ointment for treating diabetic foot ulcer and a preparation method thereof, wherein the ointment is prepared from the following raw materials in percentage by weight: 6 to 11 percent of rhubarb, 6 to 11 percent of coptis chinensis, 6 to 11 percent of phellodendron bark, 14 to 19 percent of gypsum, 12 to 17 percent of lithospermum, 14 to 20 percent of angelica, 7 to 11 percent of angelica dahurica, 2 to 5 percent of calomel, 7 to 11 percent of beautiful flowery knotweed, and 23 to 30 percent of yellow.

CN104288361a discloses a diabetic foot curing ointment for curing foot ulcer caused by diabetes, which is prepared from one part of papaya, rhizoma corydalis, giant knotweed, cattail pollen, garden burnet root (charcoal), amur corktree bark, coptis root, calcined gypsum, baical skullcap root, lightyellow sophora root and alum, and is prepared by compatibility of vaseline and sesame oil.

CN108159225a discloses a traditional Chinese medicine for treating diabetic foot, which is prepared from the following traditional Chinese medicines in parts by weight: 20g of raw astragalus, 15g of rhizoma atractylodis, 15g of amur corktree bark, 15g of medicinal cyathula root, 20g of raw rehmannia root, 20g of earthworm, 20g of red paeony root, 15g of tree peony bark, 10g of nutgrass galingale rhizome, 30g of red sage root, 15g of rhizoma corydalis, 20g of suberect spatholobus stem and 15g of dahurian angelica root.

CN111920937a discloses a traditional Chinese medicine composition for external use for diabetic foot ulcer, which is prepared from the following raw materials in parts by weight: 12-14 parts of catechu, 10-15 parts of honeysuckle, 8-10 parts of coptis chinensis, 5-9 parts of dandelion, 6-10 parts of purslane, 1-3 parts of red powder, 5-7 parts of radix scutellariae, 8-10 parts of hawthorn fruit, 5-7 parts of frankincense and 5-9 parts of ginger.

At present, the traditional Chinese medicine compound used in clinic in the prior art mainly has the defects of unobvious wound healing effect and poor curative effects on foot blood circulation, skin temperature drop, pigmentation, wound ulcer, pain and the like, so the prior art has certain treatment limitations, and a medicine or a treatment method for treating the diabetic foot ulcer, which has better clinical curative effect, low cost, short treatment period, simple and good operation, needs to be sought.

Disclosure of Invention

The invention provides a traditional Chinese medicine preparation for treating diabetic foot ulcers and a preparation method thereof, and solves the problems that the prior art has an unobvious wound healing effect in treating diabetic foot ulcers, has poor treatment effect in the aspects of foot wound ulcers, patient pains and the like, influences the life quality of patients and brings great economic burden to families and society of patients.

As an aspect of the present invention, an embodiment of the present invention provides a traditional Chinese medicine preparation, wherein raw materials of the traditional Chinese medicine preparation include: 80-120 parts of angelica, 100-160 parts of dried rehmannia root, 50-110 parts of carbonized hair, 80-120 parts of lithospermum, 20-80 parts of dragon's blood, 105-165 parts of tortoise plastron, 90-150 parts of cuttlebone, 525-725 parts of gypsum powder and 280-360 parts of calamine powder.

Preferably, the raw materials further comprise auxiliary materials with the following proportions: 900-1000 parts of yellow wax, 900-1000 parts of white wax and 1800-2400 parts of sesame oil.

Preferably, the raw materials of the traditional Chinese medicine preparation comprise: 100 parts of angelica, 125 parts of dried rehmannia root, 80 parts of crinis Carbonisatus, 100 parts of lithospermum, 50 parts of dragon's blood, 135 parts of tortoise plastron, 120 parts of cuttlebone, 635 parts of gypsum powder and 320 parts of calamine powder.

Preferably, the auxiliary materials of the traditional Chinese medicine compound preparation comprise: 950 parts of yellow wax, 950 parts of white wax and 2100 parts of sesame oil.

Preferably, the finished preparation is in the form of ointment.

As a second aspect of the present invention, an embodiment of the present invention provides a method for preparing a Chinese medicinal preparation, which mainly includes the following steps:

s1: taking sesame oil, placing the sesame oil into a pot, decocting, taking residual carbon from blood, and placing the residual carbon into the pot;

s2: taking out the carbonized hair after boiling, grinding, and obtaining the carbonized hair paste after the carbonized hair is in a paste form;

S3: taking tortoise plastron, placing the tortoise plastron into a sesame oil pot, decocting to obtain chestnut skin color, adding sesame oil, taking the dried rehmannia root, decocting to obtain scorched color, adding Chinese angelica and lithospermum until the mixture is decocted to be dry, filtering to remove dregs, and decocting with slow fire;

s4: adding sesame oil into the sesame oil pot, adding calamine powder, gypsum powder and cuttlebone powder, and decocting with slow fire;

s5: taking the pot, putting yellow wax and white wax into the pot, decocting until no foam is generated, filtering the materials in the sesame oil pot by using gauze, and extinguishing the fire after the decoction;

s6: and (5) continuously stirring to a preset temperature range, adding the residual blood paste and the dragon's blood, uniformly stirring to form paste, bottling and sealing for later use.

Preferably, the boiling time in the step S1 is 1-1.5 hours, the boiling time in the step S2 is 0.5-1.0 hours, the boiling time in the step S3 is 1.5-2.0 hours, and the boiling time in the step S4 is 1/6-1/3 hours.

Preferably, the boiling time in the step S1 is 1 hour, the boiling time in the step S2 is 0.5 hour, the boiling time in the step S4 is 1.5 hours with slow fire, and the boiling time in the step S5 is 1/6 hour.

And (3) adding gypsum powder in the step (S4), wherein the gypsum powder generates calcined gypsum during decoction.

Preferably, the preparation method comprises the following steps:

s1: taking 1100 parts of sesame oil, putting the sesame oil into a pot, decocting, taking 80 parts of carbonized hair, and putting the carbonized hair into the pot;

S2: taking out the carbonized hair after boiling, grinding, and obtaining the carbonized hair paste after the carbonized hair is in a paste form;

s3: taking 135 parts of tortoise plastron, putting the tortoise plastron into a fragrant oil pot, decocting until the color of chestnut skin is achieved, adding 600 parts of sesame oil, taking 125 parts of raw rehmannia root, decocting until the color of scorched color is achieved, adding 100 parts of Chinese angelica and 100 parts of lithospermum, decocting until the color is achieved, filtering, removing dregs, and decocting with slow fire;

s4: 400 parts of sesame oil is taken and put into the sesame oil pot, 320 parts of calamine powder, 635 parts of gypsum powder and 120 parts of cuttlebone powder are added, and then the mixture is boiled with slow fire;

s5: taking a pot, putting 950 parts of yellow wax and 950 parts of white wax into the pot, decocting until no foam exists, filtering the materials in a sesame oil pot by using gauze, and extinguishing the fire after decoction;

s6: continuously stirring until the temperature is reduced to a preset temperature range, adding the residual blood paste and 50 parts of dragon's blood, uniformly stirring to form paste, bottling and sealing for later use.

In summary, the embodiment of the invention provides a traditional Chinese medicine preparation for treating diabetic foot ulcer and a preparation method thereof, wherein the traditional Chinese medicine preparation comprises the raw materials of 80-120 parts of angelica sinensis, 100-160 parts of dried rehmannia root, 50-110 parts of crinis Carbonisatus, 80-120 parts of lithospermum, 20-80 parts of dragon's blood, 105-165 parts of tortoise plastron, 90-150 parts of cuttlebone, 525-725 parts of gypsum powder, 280-360 parts of calamine powder and auxiliary materials: 900-1000 parts of yellow wax, 900-1000 parts of white wax and 1800-2400 parts of sesame oil; the traditional Chinese medicine preparation has the characteristics of obvious clinical curative effect and low price, has the effects of promoting blood circulation, removing toxicity, promoting granulation, growing flesh, astringing dampness, healing sores and promoting skin growth in the aspect of treating diabetic foot ulcers, improves the symptoms of poor blood circulation, skin temperature drop, pigmentation, wound surface ulcer infection and the like of the affected foot, is not easy to relapse after stopping the medicine, and has the clinical effective rate of more than 95 percent. The preparation method of the traditional Chinese medicine preparation comprises the following steps: taking sesame oil, placing the sesame oil into a pot, decocting, taking residual carbon from blood, and placing the residual carbon into the pot; taking out the carbonized hair after boiling, grinding, and obtaining the carbonized hair paste after the carbonized hair is in a paste form; taking tortoise plastron, putting the tortoise plastron into a fragrant oil pot, boiling the tortoise plastron into chestnut skin color, adding sesame oil, taking the raw rehmannia root, boiling the raw rehmannia root into scorched color, adding Chinese angelica and lithospermum till the raw materials are boiled, filtering to remove all residues, and boiling with slow fire; adding oleum Sesami into a pan, adding Galamina powder, gypsum Fibrosum powder, and Os Sepiae powder, and decocting with slow fire; taking a pot, putting yellow wax and white wax into the pot, decocting until no foam exists, filtering with gauze in a sesame oil pot, and extinguishing fire after boiling; continuously stirring until the temperature is slightly reduced, adding the residual blood paste and the resina Draconis, uniformly stirring to form paste, bottling, and sealing for later use; the preparation method has the advantages of simple operation, simple equipment, short operation time and low cost, can realize large-scale preparation, greatly improve the life quality of patients, simultaneously reduce the medical expenses of the patients, realize healthy happy life of the patients, realize mass production and have extremely high development prospect.

Drawings

In order to more clearly illustrate the technical solution of the embodiments of the present invention, the drawings that are needed to be used in the embodiments of the present invention will be briefly described, and other drawings can be obtained according to these drawings without inventive effort for a person skilled in the art.

Fig. 1 is a process flow diagram of the preparation of the Chinese herbal compound preparation.

Fig. 2 is a diagram of a control group for treatment of diabetic foot ulcers in clinical cases.

Fig. 3 is a graph showing the effect of the external application of the traditional Chinese medicine preparation for 2 weeks after debridement and dressing change of diabetic foot ulcers in clinical cases.

Fig. 4 is a graph showing the effect of the external application of the traditional Chinese medicine preparation for 4 weeks after curing diabetic foot ulcer in clinical cases.

Fig. 5 is a graph showing the effect of the external application of the traditional Chinese medicine preparation for 6 weeks after the diabetic foot ulcer in clinical cases.

Fig. 6 is a graph showing the effect of the external application of the Chinese medicinal preparation for treating diabetic foot ulcer in clinical cases after 8 weeks.

Detailed Description

Features and exemplary embodiments of various aspects of the present invention will be described in detail below, and in order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in further detail below with reference to the accompanying drawings and examples. It should be understood that the specific embodiments described herein are merely configured to illustrate the invention and are not configured to limit the invention. It will be apparent to one skilled in the art that the present invention may be practiced without some of these specific details. The following description of the embodiments is merely intended to provide a better understanding of the invention by showing examples of the invention.

It is noted that relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising … …" does not exclude the presence of other like elements in a process, method, article or apparatus that comprises the element.

The invention mainly relates to a traditional Chinese medicine compound preparation for treating diabetic foot ulcer and a preparation method thereof.

Example 1:

a traditional Chinese medicine preparation for treating diabetic foot ulcers, the traditional Chinese medicine preparation comprises the following raw materials: 80-120 parts of angelica, 100-160 parts of dried rehmannia root, 50-110 parts of carbonized hair, 80-120 parts of lithospermum, 20-80 parts of dragon's blood, 105-165 parts of tortoise plastron, 90-150 parts of cuttlebone, 525-725 parts of gypsum powder, 280-360 parts of calamine powder and auxiliary materials: 900-1000 parts of yellow wax, 900-1000 parts of white wax and 1800-2400 parts of sesame oil.

The finished product preparation is ointment.

The efficacy and effect of each medicine in the above formula:

dang Gui is sweet and pungent in flavor and warm in nature; replenishing blood, promoting blood circulation, regulating menstruation, relieving pain, and loosening bowel to relieve constipation;

the dried rehmannia root is sweet, bitter, salty and slightly cold in taste; clearing heat and cooling blood, nourishing yin and reducing fire, and detoxicating and resolving hard mass;

tortoise plastron is salty, sweet and slightly cold in nature; nourishing yin, suppressing yang, invigorating kidney, strengthening bone, nourishing blood, tonifying heart, and consolidating menstruation to stop metrorrhagia;

the residual blood is bitter in taste and flat in nature; astringing to stop bleeding, removing blood stasis, and promoting urination;

lithospermum is sweet, salty and cold in nature; clearing heat and cooling blood, activating blood and detoxicating, promoting eruption and eliminating spots;

the dragon's blood is sweet, salty and neutral in nature; promoting blood circulation, relieving pain, removing blood stasis, stopping bleeding, promoting tissue regeneration, and healing sore;

cuttlebone is salty, astringent and warm in nature; astringing to stop bleeding, astringing essence to stop leukorrhagia, relieving hyperacidity and pain;

the gypsum powder is prepared into calcined gypsum when being decocted, and the calcined gypsum is sweet and spicy and has great cold property; promoting granulation, healing sore and stopping bleeding;

calamina powder is sweet in taste and neutral in nature; detoxify, improve vision, remove nebula, astringe dampness, relieve itching and heal wound.

The traditional Chinese medicine preparation disclosed by the embodiment of the invention has the advantages of simple raw materials, wide sources and low cost, has the effects of activating blood and detoxicating, promoting granulation and growing meat, dehumidifying and healing sores and promoting skin growth, can well improve the symptoms of poor foot blood circulation, skin temperature reduction, pigmentation, wound surface ulcer infection and the like of a patient, greatly reduces the medical cost of the patient and improves the life quality of the patient.

Example 2:

the embodiment of the invention provides a preparation method of a traditional Chinese medicine preparation, which mainly comprises the following steps:

s1: taking sesame oil, placing the sesame oil into a pot, decocting, taking residual carbon from blood, and placing the residual carbon into the pot;

s2, taking out the crinis Carbonisatus after boiling, grinding the crinis Carbonisatus into fine powder, and obtaining crinis Carbonisatus paste after the crinis Carbonisatus is in a paste form;

s3: taking tortoise plastron, placing the tortoise plastron into a sesame oil pot, decocting to obtain chestnut skin color, adding sesame oil, taking the dried rehmannia root, decocting to obtain scorched color, adding Chinese angelica and lithospermum into the scorched color, removing residues, filtering, and decocting again with slow fire;

s4: adding sesame oil into the sesame oil pot, adding calamine powder, gypsum powder and cuttlebone powder, and decocting with slow fire;

s5: taking the pot, putting yellow wax and white wax into the pot, decocting until no foam is generated, filtering the materials in the sesame oil pot by using gauze, and extinguishing the fire after the decoction;

s6: continuously stirring until the temperature is reduced to a preset temperature range, adding the residual blood paste and the dragon's blood, uniformly stirring to form paste, bottling and sealing for later use.

Preferably, the sesame oil in the step S1 is boiled for 1-1.5 hours, the residual carbon in the step S2 is boiled for 0.5-1.0 hour, the slow fire in the step S4 is boiled for 1.5-2.0 hours, and the boiling time in the step S5 is 1/6-1/3 hours.

The medicine is added with the fragrant oil for three times, so that the medicine effect can be better ensured, and the medicine effect of the decocted medicinal materials can be fully exerted.

In one embodiment, the boiling time in the step S1 is 1 hour, the boiling time in the step S2 is 0.5 hour, the boiling time in the step S4 is 1.5 hours, and the boiling time in the step S5 is 1/6 hour.

The preparation method of the traditional Chinese medicine preparation provided by the embodiment is simple to operate, simple in equipment, low in manufacturing cost, short in preparation time and high in efficiency, can easily realize large-scale preparation, and has a good development prospect.

The traditional Chinese medicine preparation provided by the invention is particularly used for treating diabetic foot ulcers, can obviously shorten the wound healing time, greatly improve the wound healing rate and the life quality of diabetic foot ulcers, has definite curative effect, and is worthy of further popularization and application in clinic.

Example 3

The traditional Chinese medicine preparation for treating diabetic foot ulcer of the embodiment 3 comprises the following raw materials: 80 parts of Chinese angelica, 100 parts of dried rehmannia root, 50 parts of carbonized hair, 80 parts of lithospermum, 20 parts of dragon's blood, 105 parts of tortoise plastron, 90 parts of cuttlebone, 525 parts of gypsum powder and 280 parts of calamine powder, wherein the auxiliary materials of the Chinese medicinal preparation comprise: 950 parts of yellow wax, 950 parts of white wax and 1800 parts of sesame oil.

In one embodiment, a method for preparing a traditional Chinese medicine preparation for treating diabetic foot ulcers comprises the following steps:

The traditional Chinese medicine compound preparation comprises the following raw materials: 80 parts of Chinese angelica, 100 parts of Chinese medicinal dried rhizome of rehmannia, 50 parts of Chinese medicinal carbonized hair, 80 parts of Chinese medicinal lithospermum, 20 parts of Chinese medicinal dragon's blood, 105 parts of Chinese medicinal tortoise plastron, 90 parts of Chinese medicinal cuttlebone, 525 parts of gypsum powder and 280 parts of Chinese medicinal calamine powder, wherein the auxiliary materials of the Chinese medicinal compound preparation comprise: 950 parts of yellow wax, 950 parts of white wax and 1800 parts of sesame oil;

the preparation method of the traditional Chinese medicine compound preparation comprises the following steps:

taking 1000 parts of sesame oil, placing the sesame oil into a pot, decocting for 1-1.5 hours, taking 50 parts of carbonized hair, and placing the carbonized hair into the pot;

decocting for 0.5-1.0 hr, taking out the crinis Carbonisatus, grinding, and making into paste to obtain crinis Carbonisatus paste;

taking 105 parts of tortoise plastron, putting the tortoise plastron into a fragrant oil pot, decocting until the color of the chestnut skin is changed, adding 500 parts of sesame oil, taking 100 parts of raw rehmannia root, decocting until the color of the chestnut skin is changed, adding 80 parts of Chinese angelica and 80 parts of lithospermum, removing residues, filtering, and decocting with slow fire;

adding 300 parts of sesame oil into the sesame oil pot, adding 280 parts of calamine powder, 525 parts of gypsum powder and 90 parts of cuttlebone powder, and decocting with slow fire for 1.5-2.0 hours;

taking the mixture into a pot, putting 900 parts of yellow wax and 900 parts of white wax into the pot, decocting until no foam exists, filtering the mixture into a sesame oil pot by using gauze, and extinguishing the fire after 1/6 to 1/3 of the time after the decoction;

Continuously stirring until the temperature is slightly reduced, adding the obtained residual blood paste and 20 parts of resina Draconis, uniformly stirring, bottling and sealing for later use.

Preferably, in the above method steps, the boiling time in the step S1 is 1 hour, the boiling time in the step S2 is 0.5 hour, the boiling time in the step S4 is 1.5 hours, and the boiling time in the step S5 is 1/6 hour.

Example 4

The traditional Chinese medicine preparation for treating diabetic foot ulcer of the embodiment 4 comprises the following raw materials: 120 parts of angelica, 160 parts of dried rehmannia root, 110 parts of crinis Carbonisatus, 120 parts of lithospermum, 80 parts of dragon's blood, 165 parts of tortoise plastron, 150 parts of cuttlebone, 725 parts of gypsum powder, 360 parts of calamine powder, 1000 parts of yellow wax, 1000 parts of white wax and 2400 parts of sesame oil.

The preparation method is the same as the preparation method.

Example 5

The traditional Chinese medicine preparation for treating diabetic foot ulcer in the embodiment 5 comprises the following components: 90-110 parts of angelica, 110-150 parts of dried rehmannia root, 60-100 parts of carbonized hair, 90-110 parts of lithospermum, 30-70 parts of dragon's blood, 115-155 parts of tortoise plastron, 100-140 parts of cuttlebone, 575-700 parts of gypsum powder, 290-350 parts of calamine powder and auxiliary materials: 910 to 980 parts of yellow wax, 910 to 980 parts of white wax and 1900 to 2300 parts of sesame oil.

The preparation method is the same as the preparation method.

Example 6

The traditional Chinese medicine preparation for treating diabetic foot ulcer of the embodiment 6 comprises the following raw materials: 95-105 parts of angelica, 115-130 parts of dried rehmannia root, 70-90 parts of crinis Carbonisatus, 95-105 parts of lithospermum, 40-60 parts of dragon's blood, 120-150 parts of tortoise plastron, 110-130 parts of cuttlebone, 600-675 parts of gypsum powder, 300-340 parts of calamine powder, 920-970 parts of yellow wax, 920-970 parts of white wax and 2000-2200 parts of sesame oil.

The preparation method is the same as the preparation method.

Example 7

The traditional Chinese medicine preparation for treating diabetic foot ulcer of the embodiment 7 comprises the following raw materials: 100 parts of angelica, 125 parts of dried rehmannia root, 80 parts of crinis Carbonisatus, 100 parts of lithospermum, 50 parts of dragon's blood, 135 parts of tortoise plastron, 120 parts of cuttlebone, 635 parts of gypsum powder, 320 parts of calamine powder, 950 parts of yellow wax, 950 parts of white wax and 2100 parts of sesame oil.

In one embodiment, the method of preparation comprises:

s1: taking 1100 parts of sesame oil, putting the sesame oil into a pot, decocting, taking 80 parts of carbonized hair, and putting the carbonized hair into the pot;

s2: taking out the carbonized hair after boiling, grinding, and obtaining the carbonized hair paste after the carbonized hair is in a paste form;

s3: taking 135 parts of tortoise plastron, putting the tortoise plastron into a fragrant oil pot, decocting until the color of chestnut skin is achieved, adding 600 parts of sesame oil, taking 125 parts of raw rehmannia root, decocting until the color of scorched color is achieved, adding 100 parts of Chinese angelica and 100 parts of lithospermum, decocting until the color is achieved, filtering, removing dregs, and decocting with slow fire;

S4: 400 parts of sesame oil is taken and put into the sesame oil pot, 320 parts of calamine powder, 635 parts of gypsum powder and 120 parts of cuttlebone powder are added, and then the mixture is boiled with slow fire;

s5: taking a pot, putting 950 parts of yellow wax and 950 parts of white wax into the pot, decocting until no foam exists, filtering the materials in a sesame oil pot by using gauze, and extinguishing the fire after decoction;

s6: continuously stirring until the temperature is reduced to a preset temperature range, adding the residual blood paste and 50 parts of dragon's blood, uniformly stirring to form paste, bottling and sealing for later use.

Example 8

In this example 8, the preparation method further comprises pretreatment of the medicinal materials in the Chinese medicinal preparation, selecting, cleaning, drying, cutting, pulverizing, screening, etc. of the Chinese medicinal materials, removing impurities and dust in the materials, and changing the purity and purity of the prepared Chinese medicinal preparation to some extent.

Example 9

In the above preparation method of the traditional Chinese medicine preparation, the method further comprises the step of adjusting the proportion of the traditional Chinese medicine preparation according to the injury degree of a patient, and comprises the following steps:

obtaining the injury degree of a patient;

the proportion of the traditional Chinese medicine preparation is adjusted according to the injury degree.

Specifically, the obtaining the patient's injury and suffering degree includes:

making a rating of the extent of injury, the rating of the extent of injury comprising: obtaining a composite score for the affected area of the wound, the composite score comprising: wound surface score, pain score, quality of life score, safety score. The injury degree rating is made according to different comprehensive scores.

And (3) adjusting the proportion of the traditional Chinese medicine preparation according to different injury degree grades to obtain the traditional Chinese medicine preparation with different drug effect degrees.

According to the method, the traditional Chinese medicine preparation with different degrees of efficacy is obtained by grading different degrees of injury, so that the injury with different degrees can be better treated, the patients can be subjected to symptomatic medication, and the economic burden can be relieved while the patients are treated.

Example 10

In this example 10, in the above-described formulation of the example, the preferable drug effect is: example 1 (example 3 or 4) < example 5< example 6< example 7, in the course of treatment, when the therapeutic effect of the Chinese medicinal preparation of the current proportion adopted does not reach the desired therapeutic effect according to the judgment standard, more effective proportion of the Chinese medicinal preparation can be adopted for treatment; likewise, when the therapeutic effect of the traditional Chinese medicine preparation according to the current proportion is adopted and reaches or exceeds the expected therapeutic effect according to the judgment standard, other proportions of therapeutic effects can be adopted according to the healing degree of the affected part of the patient, and the healing of the affected part of the patient is ensured while the economic pressure of the patient is relieved.

For example, as shown in fig. 2, 3, 4, 5 and 6, fig. 2 is a control chart of affected parts of a patient before treatment, fig. 3 is a graph of effects of the traditional Chinese medicine preparation after 2 weeks of treatment, and the patient is seriously injured before treatment and after 2 weeks of treatment, which is treated by adopting traditional Chinese medicine preparations with better proportion, and when the patient is in fig. 4, 5 and 6, the traditional Chinese medicine preparations with different proportions can be selected according to the healing degree of the affected parts.

The judging criteria of the treatment effect include: the wound surface scoring after 7d by adopting the VSD negative pressure sealing technology, the efficacy onset time of the traditional Chinese medicine preparation, the dressing change pain scoring after 7d by adopting the VSD negative pressure sealing technology, the clinical curative effect, the life quality evaluation and the safety evaluation.

The dosage of the traditional Chinese medicine preparation is as follows: firstly, about 1g of the traditional Chinese medicine preparation is uniformly smeared on a sterile gauze dressing, and the traditional Chinese medicine preparation is covered on a wound surface on the basis of debridement. Cutting sterile gauze into long strips for fistula, uniformly smearing the traditional Chinese medicine preparation, threading the strips with a sterile Kirschner wire to fill the fistula, covering the wound surface with the sterile gauze dressing, and finally wrapping with the sterile dressing. And (5) carrying out periodic dressing change according to the exudation condition for 3-5 days by the same method until the wound surface heals. The patients with short disease course can be cured, the symptoms of the patients with long disease course can be obviously relieved, and the curative effect is obvious.

The traditional Chinese medicine preparation has the advantages of simple operation process, simplicity and easy understanding of operators, low operation cost and capability of being operated by common people.

The preparation method of the traditional Chinese medicine preparation provided by the embodiment is simple to operate, simple in equipment, low in manufacturing cost, short in preparation time and high in efficiency, can easily realize large-scale preparation, and has a good development prospect.

The traditional Chinese medicine preparation provided by the invention is particularly used for treating diabetic foot ulcers, has remarkable treatment effect, can obviously shorten the wound healing time, greatly improve the wound healing rate of diabetic foot ulcers, effectively reduce the pain degree, shorten the pain time of patients and improve the postoperative life quality of the patients, has wide sources of raw materials and low cost of raw materials, is simple in preparation method and preparation equipment, has low preparation cost, can easily realize large-scale preparation, can greatly reduce the economic burden of families and society of patients, is beneficial to improving the life quality of the families of the patients and the establishment of good society, and is worthy of further popularization and application clinically. The advantages of using the above-described Chinese medicinal preparation in treating diabetic foot in a patient are further illustrated by the experimental data collected in clinic by the applicant.

Efficacy experiment:

1. test procedure

1.1 test and control groups

50 diabetic foot ulcer patients who are collected and treated in the department of science within one year of the hospital are selected. The random number table method is adopted according to the following formula 1:1 were randomly divided into two groups, 25 for each of the test and control groups. Wherein 27 men and 23 women are aged 49-76 years, and average age is 55.66+ -3.21 years; the disease course is 8-25 years, and the average time is 16.54+/-1.00 years. All patients were followed for 3 months after treatment, and no adverse drug reaction was observed during the follow-up. The age, sex and disease course of the two groups of patients are different from each other in a statistically significant way (P > 0.05), and the patients are comparable.

1.2 case selection

(1) Inclusion criteria

A. Meets the diagnosis standard in the Chinese diabetes foot control guide 2019 edition.

B. The diabetic foot Wagner was rated 1-4.

C. The patient has clear consciousness, good compliance, good diet control, and stable blood sugar control, and the whole course of treatment needs to be participated in blood sugar reducing treatment.

D. The situation of the undermining is clear, and the treatment informed consent is signed voluntarily.

E. Has no severe gravity center, brain, liver and kidney insufficiency, and no serious complications.

F. Approved by the ethical committee of hainan province.

(2) Exclusion criteria

A. Allergic constitution or intolerance during study, drug allergy.

B. Coagulation dysfunction and anemia.

C. Mental retardation and cognitive impairment.

D. The diabetic gestation period, serious diabetic complications include ketoacidosis.

E. Diseases affecting wound healing, such as malnutrition, tumor, and during radiotherapy and chemotherapy.

(3) Standard for termination of test or case drop

A. Serious other diseases or serious adverse reactions occur during the course of the test, and it is difficult to continue with the test.

B. Poor compliance and failure to follow the protocol during treatment.

C. The non-therapeutic reasons have proactively led to patients who have withdrawn from the trial or who are required to take other treatments.

1.3 methods of treatment

(1) Basic treatment, that is, all patients are subjected to reasonable diet, proper exercise, active hypoglycemic, infection control and other western medicine conventional treatments, and the blood sugar reaches an ideal state under the conventional hypoglycemic scheme. Seven sections of blood sugar monitoring and double lower limb blood vessel color ultrasonic examination are carried out every day to track the existence of blood vessels without blocking so as to prevent the occurrence of ischemic necrosis of the double lower limbs. If necessary, the medicine, intervention or vascular surgery is used for dredging the blood vessel and promoting the recovery of limb blood circulation. The patients with obvious infection can select proper antibiotics according to the drug sensitivity test, so as to achieve the aim of controlling the infection.

(2) Physical debridement: physical debridement is the basis of diabetic foot treatment, and is a method for thoroughly removing necrotic superficial, deep and bone tissues as much as possible by using instruments such as a sharp instrument, a tissue forceps and the like, wherein the removal range comprises all necrotic tissues, crusts and the like around a wound surface. For patients with bone destruction caused by serious infection and osteomyelitis which can be treated by drug standardization and thereby protect limbs, the necrotic broken bone pieces can be gradually removed. When deep tissue infections such as osteomyelitis, deep abscess, necrotizing fasciitis, etc. are combined, drainage should be immediately cut. Effective and thorough physical debridement can also control the further development of infection while removing necrotic tissue. In the processing of the measures, the following processing principles are followed: (1) The lowest point is expanded, the highest point of the tension and the obvious fluctuation are cut; (2) The longitudinal incision is selected as far as possible, and the arch of the instep and the sole is fully cared when the incision is designed; (3) the plantar incision avoids bearing and friction parts; (4) Reserving the 1 st and 5 th metatarsal bones as much as possible to reserve the foot weight bearing function; (5) The active tissue is kept as much as possible according to the function and the appearance; (6) the wound surface is kept in a moist environment.

(3) VSD negative pressure (negative pressure closed drainage technique) closed treatment: after thorough debridement in operation, 75% ethanol at the periphery of the wound surface is wiped, the VSD negative pressure device is covered, the sponge completely covers the wound surface, and the test negative pressure is closed and the drainage is smooth.

1.4 treatment modality:

clinical trials were performed on the trial and control groups using a randomized controlled double-blind trial, with 3 months follow-up recording of the cases.

Test group: removing the wound after 1-2 weeks by using the VSD negative pressure device, observing the granulation degree of the wound, and covering the wound with the traditional Chinese medicine preparation disclosed by the invention, wherein no obvious necrotic tissues and the like exist. Cutting sterile gauze into long strips for fistula, uniformly smearing the traditional Chinese medicine preparation, threading the strips with a sterile Kirschner wire to fill the fistula, covering the wound surface with the sterile gauze dressing, and finally wrapping with the sterile dressing. And periodic dressing changes were performed according to the same method as the exudation conditions 3-5 d.

After a treatment course is closed by adopting wound repair VSD negative pressure, in the wound repair process, when Wagner classification is 1-2, a test group can uniformly apply the traditional Chinese medicine compound preparation provided by the invention on a sterile gauze piece, apply the traditional Chinese medicine compound preparation on a wound, wrap the dressing, and replace the dressing every other day. If the wound surface still has sinus tracts or exposed bones, the test group uniformly smears the traditional Chinese medicine compound preparation provided by the invention on a gauze block to fill the sinus tracts and cover the wound surface, and finally dressing is wrapped, dressing is changed every other day, and continuous treatment is carried out for 2 days.

Control group: the conventional VSD negative pressure sealing technology after debridement is adopted, and the technology such as VSD negative pressure sealing technology or skin grafting (skin flap transfer technology) or antibiotic bone cement sinus filling can be continuously used for two times according to the granulation condition and the sinus condition after 1-2 weeks. And (5) after the wound surface is contracted or the sinus tract is closed, performing surgery to change the medicine periodically. After a treatment course of wound repair VSD negative pressure sealing, if Wagner classification belongs to 1-2 grades in the wound repair process, the control group can apply vaseline gauze pieces of the wound, and change the dressing conventionally (once every other day). If the wound granulation tissue is fresh, the particles are compact and have fresh blood exudation, skin grafting treatment (namely, the inner side of thigh is planted in the wound surface by 0.15-0.25 mm) can be carried out, and the skin grafting position is pressurized and packed or is closed and sucked by VSD (vacuum storage device) again. If the wound surface still has sinus tracts or exposed bones, the control group fills the defect after being blended by antibiotic bone cement (vancomycin, tobramycin and the like) and completely covers the wound surface.

1.4 Standard of efficacy

Treatment effect grade, the treatment effect of two groups of patients is observed, and the treatment effect grade is judged, wherein the treatment effect grade comprises three grades of obvious effect, effective and ineffective.

Judgment standard:

(1) Comparing the two groups of wound surface scores after 7d of treatment by adopting the VSD negative pressure sealing technology, and evaluating the wound surface recovery condition after 7d of treatment according to the wound surface color change condition, wherein the method comprises the following specific steps: (1) 2, the method comprises the following steps: the wound surface is red, exudation is less, and the granulation is bright red; (2) 1, the method comprises the following steps: the wound surface is pink, serum-like exudation is less, and granuloma is pink; (3) 0 point: the wound surface is tarnish, purulent secretion/serum-like exudation is more, and granulation does not grow. The higher the score, the better the patient wound recovery.

(2) Two sets of onset times were compared: the time required from the start of treatment to the start of reduction of the wound surface (time required for complete epithelialization of the wound surface, macroscopic epithelialization).

(3) Comparing two groups of VSD negative pressure closure techniques, the post-operative pain degree of the dressing change for the patient in group 2 was assessed using the international pain visual simulation (Visual Analogue Score, VAS) score scale for the 7d post-operative pain degree of the patient in group 2, ranging from 0 to 10 points, i.e. 0 points (no pain), 1 to 3 points (mild pain, tolerable), 4 to 6 points (moderate pain, tolerable, but sleep-affecting), 7 to 10 points (severe pain, intolerable, severe sleep-affecting, appetite). The higher the score, the more severe the pain level of the patient.

(4) Comparing the two groups of clinical curative effects, wherein the judging standard wound healing rate is = (original wound area-existing wound area)/original wound area is multiplied by 100%, limb diffuse infiltration red swelling completely disappears, the tissue gap is closed, and the wound healing rate is more than or equal to 80%; the diffuse and invasive red swelling of the limbs is obviously relieved, partial granulation is regenerated, and the wound healing rate is effective between 40% and 79%; the limb swelling and wound surface are not changed, and the aggravation trend is ineffective.

(5) Quality of life assessment patients' quality of life was assessed using the health survey profile (SF-36). There are 36 entries, which can be summarized as two major categories of physical and mental health, and are divided into 8 dimensions, namely Physiological Function (PF), physiological function (RP), somatic pain (BP), energy (VT), social Function (SF), emotional function (RE), mental Health (MH), and general health status (GH). The maximum possible score of each dimension is 100, the minimum score is 0, the sum of the scores of 8 dimensions is the comprehensive score, and the higher the score, the better the quality of life. All patients were scored for SF-36 before treatment, 7 days after treatment, 14 days after treatment, 30 days after treatment, and 60 days after treatment.

(6) Safety evaluation

And (3) observing the indexes: liver and kidney functions (ALT/AST/BUN/Cr), three general examinations (blood, urine, stool), and electrocardiogram, one examination before and after treatment; adverse reactions (adverse reactions such as drug allergy, skin itching, wound infection, ulcer and the like) possibly occurring during the administration should be recorded as actual records, including appearance time, symptom signs, whether drug withdrawal is needed, treatment measures and the like.

Evaluation criteria: the level 1 is safe, no adverse reaction exists, and no abnormality exists in the safety index inspection; the grade 2 is safer, has slight adverse reaction, can be continuously administered without any treatment, and has no abnormality in safety index inspection; the level 3 is a safety problem, has moderate adverse reaction, has slight abnormality in safety index inspection, and can be continuously administered after treatment; the level 4 is a discontinuation test due to adverse reactions, or a significant abnormality in the safety index check.

2. Results

2.1 comparison of 7d wound scores after two groups of VSD negative pressure blocking treatments: the difference was statistically significant (P > 0.05) compared to the 7d wound score before treatment for the two groups of patients. The scores of the 7d post-treatment test group were higher than the control group, and the differences were statistically significant (P < 0.05), as shown in Table 1. The comparison of the two groups of data can easily show that after the same early treatment, the average wound surface score of a tester after 7d is about 72.3 percent higher than that of a control group after the medicament is externally applied, so that the medicament can be used for efficiently treating the affected part of a patient in a short time, and the wound surface recovery condition of the test group is excellent.

Table 1 comparison of wound scores of two groups of patients before and after debridement for 7d

Group of	Number of examples	Before treatment	After treatment
				Control group	25	0.47±0.03	1.05±0.30
Test group	25	0.48±0.04	1.81±0.31

2.2 Comparison of appearance of new epithelium and complete healing time of wound surface in VSD negative pressure closed treatment: the appearance of new epithelium after treatment of both groups of patients was significantly lower than that of the control group compared with the time to complete wound healing, and the differences were statistically significant (P < 0.05), as shown in Table 2. From the two groups of data, after the medicament provided by the invention is externally applied, the appearance time of the new epithelium of the test group and the complete healing time of the wound surface are far higher than those of the control group, which indicates that the medicament provided by the invention can effectively shorten the treatment time of patients.

Table 2 comparison of time to complete wound healing with appearance of new epithelium in two groups of patients

Group of	Number of examples	Time of appearance of new epithelium	Time for complete healing of wound surface
				Control group	25	11.25±2.57	86.43±4.56
Test group	25	7.22±3.62	60.22±4.37

2.3 comparison of pain scores after VSD negative pressure blocking treatment for two groups of patients: the difference was statistically significant (P > 0.05) compared to the VAS scores before and after treatment for the two groups of patients. The post-treatment test group had significantly lower VAS scores than the control group, and the differences were statistically significant (P < 0.01), as shown in Table 3. From the two groups of data, after the medicament is externally applied, the VAS score after 7d of the test group is reduced by about 71.6% compared with that before 7d, and after 7d, the VAS score test group is reduced by about 53.8% compared with that of the control group, so that the medicament can effectively reduce pain of patients in a short time and improve life quality of the patients.

Table 3 comparison of the VAS score before and after treatment for two groups of patients

2.4 comparison of clinical efficacy in two groups of patients: the test group healed 7 cases after 60d of treatment, had 13 cases with effect, 5 cases with effect, better than the control group healed 1 case, 8 cases with effect, and the comparison difference has statistical significance (P < 0.01), see Table 4. From the two groups of data, the treatment effect of the test group is obviously better than that of the control group after the medicament is externally applied, which indicates that the medicament can effectively treat diabetic foot ulcer and has obvious treatment effect.

Table 4 comparison of clinical efficacy (n/%)

2.5 quality of life score comparison: the difference was statistically significant (P > 0.05) compared to the pre-treatment SF-36 score for the two groups of patients. After treatment was recorded separately, the ODI scores were significantly higher in the test group than in the control group, and the differences were statistically significant (P < 0.01), as shown in tables 5 and 6. As can be seen from SF-36 scoring data of two groups of patients, after the medicament provided by the invention is externally applied, the quality of life improving speed test group of the patients is superior to the control group, and the quality of life scoring test group is superior to the control group, so that the medicament provided by the invention can obviously improve the quality of life of the patients.

Table 5 comparison of SF-36 scores for two groups of patients

Group of	Number of examples	Before treatment	After 7d of treatment	After treatment for 14d
					Control group	25	369.82±152.78	389.24±118.20	430.47±153.64
Test group	25	370.91±151.66	400.47±117.64	505.45±156.64

Table 6 comparison of SF-36 scores for two groups of patients

Group of	Number of examples	After 30d of treatment	After 60d of treatment
				Control group	25	500.95±117.81	579.15±99.01
Test group	25	624.56±119.47	704.16±94.21

2.6 adverse reaction observations comparison: in the treatment observation cases, no adverse reaction patient is found, which indicates that the traditional Chinese medicine preparation is safe and reliable.

From the data in the tables 1 to 6, after the same basic treatment, debridement treatment and VSD negative pressure sealing treatment are used for patients, the traditional Chinese medicine preparation is used for covering affected parts for patients in a test group, and conventional treatment is used for a control group, so that the wound healing time is obviously shortened and the wound healing rate and survival quality of diabetic foot ulcer patients are greatly improved from the data surface of 7d wound scoring, onset time, clinical curative effect, post-operation 7d dressing change VAS scoring and life quality after treatment, and the scores of the test group are obviously better than those of the control group after the traditional Chinese medicine preparation is used, so that the traditional Chinese medicine preparation has obvious clinical curative effect, has the effects of activating blood and detoxicating, promoting granulation and growing meat, astringing dampness and astringing sores, promoting skin growth in the aspect of treating diabetic foot ulcers, and improves the symptoms of poor blood circulation, skin temperature drop, pigmentation, wound ulcer infection and the like.

Clinical cases:

a patient using the Chinese medicinal preparation was selected, and changes of affected parts of his foot before and after treatment were recorded, as shown in FIG. 2, for diabetic foot ulcers, toe, instep and plantar ulcers, and gangrene and blackening of 3 rd and 4 th toes.

After 2 weeks of treatment by debridement and dressing change of the traditional Chinese medicine preparation disclosed by the invention, as shown in fig. 3, the feet of a patient can see the pink color of toes, instep and plantar wound surfaces and are gradually covered by new epithelium tissues after treatment.

After 4 weeks of treatment, as shown in fig. 4, the affected parts had less exudation of serum, and the ulcers on the toes, dorsum and plantar had healed gradually.

After 6 weeks of treatment, the ulcer area was greatly reduced and there was no serum-like exudation, as shown in fig. 5.

After 8 weeks of treatment, as shown in fig. 6, the diabetic foot ulcer healed completely, the patient's lower limb was successfully preserved, and the risk of amputation was largely avoided.

According to clinical cases, the traditional Chinese medicine preparation provided by the invention has the advantages that after the traditional Chinese medicine preparation is used, the affected part of a patient is well treated in a short time, new muscles grow on the affected part of the foot of the patient, the symptoms of wound ulcer infection are improved, ulcers are repaired, new skin grows on the affected part of the foot, qi and blood of the foot become good, the healing effect of the affected part is good, the foot of the patient is well reserved, the healing rate and the life quality of the wound surface of the patient with diabetic foot ulcers are greatly improved, the curative effect is definite, and the traditional Chinese medicine preparation is worthy of further popularization and application in clinic.

In conclusion, the traditional Chinese medicine preparation provided by the invention has the effects of promoting blood circulation and detoxification, promoting granulation and meat growth, eliminating dampness and promoting wound healing, promoting skin growth and the like in the aspect of treating diabetic foot ulcers, improves symptoms such as poor foot blood circulation, skin temperature reduction, pigmentation, wound ulcer infection and the like, obviously shortens the wound healing time, greatly improves the wound healing rate and the life quality of diabetic foot ulcer patients, has definite curative effect, is not easy to relapse after stopping the medicine, and is worthy of further popularization and application in clinic; solves the problems that the existing clinical treatment of diabetic foot ulcer can only rely on minimally invasive operations such as lower limb arterial intervention treatment, vascular reconstruction and the like, local auxiliary treatment, even amputation operation and the like, and fills up the defect that the existing clinical western medicines have no definite effects of improving diabetic foot ulcer repair, suffering from foot blood supply, suffering from foot paresthesia and avoiding amputation and disability.

The preparation method of the traditional Chinese medicine preparation provided by the invention has the advantages of simple operation, simple equipment, wide and easily available raw material sources, low raw material cost, low preparation cost, short preparation time, high preparation efficiency, reduction of the treatment cost of patients, great reduction of the economic burden of families and society of the patients, contribution to improving the life quality of the families of the patients and the establishment of a good society, and good development prospect.

Claims (10)

1. The traditional Chinese medicine preparation for treating diabetic foot ulcer is characterized by comprising the following traditional Chinese medicine raw materials: 80-120 parts of angelica sinensis, 100-160 parts of dried rehmannia root, 50-110 parts of carbonized hair, 80-120 parts of lithospermum, 20-80 parts of dragon's blood, 105-165 parts of tortoise plastron, 90-150 parts of cuttlebone, 525-725 parts of gypsum powder and 280-360 parts of calamine powder.

2. The traditional Chinese medicine preparation according to claim 1, further comprising the following auxiliary materials: 900-1000 parts of yellow wax, 900-1000 parts of white wax and 1800-2400 parts of sesame oil.

3. The traditional Chinese medicine preparation according to claim 1, wherein the traditional Chinese medicine raw materials of the traditional Chinese medicine preparation are: 100 parts of angelica, 125 parts of dried rehmannia root, 80 parts of crinis Carbonisatus, 100 parts of lithospermum, 50 parts of dragon's blood, 135 parts of tortoise plastron, 120 parts of cuttlebone, 635 parts of gypsum powder and 320 parts of calamine powder.

4. The traditional Chinese medicine preparation according to claim 3, wherein the auxiliary materials of the traditional Chinese medicine preparation comprise: 950 parts of yellow wax, 950 parts of white wax and 2100 parts of sesame oil.

5. The Chinese medicinal preparation according to any one of claims 1 to 4, wherein the finished Chinese medicinal preparation is in the form of an ointment.

6. A method of preparing a Chinese medicinal formulation according to any one of claims 1 to 5, comprising the steps of:

S1: taking sesame oil, placing the sesame oil into a pot, decocting, taking residual carbon from blood, and placing the residual carbon into the pot;

s2: taking out the carbonized hair after boiling, grinding, and obtaining the carbonized hair paste after the carbonized hair is in a paste form;

s3: taking tortoise plastron, placing the tortoise plastron into a sesame oil pot, decocting to obtain chestnut skin color, adding sesame oil, taking the dried rehmannia root, decocting to obtain scorched color, adding Chinese angelica and lithospermum, decocting until the mixture is completely cooked, filtering, removing dregs, and decocting again with slow fire;

s4: adding sesame oil into the sesame oil pot, adding calamine powder, gypsum powder and cuttlebone powder, and decocting with slow fire;

s5: taking a pot, putting yellow wax and white wax into the pot, decocting until no foam exists, filtering the mixture in the perfume oil pot by using gauze, and extinguishing the fire after the decoction;

s6: continuously stirring until the temperature is reduced to a preset temperature range, adding the residual blood paste and the dragon's blood, uniformly stirring to form paste, bottling and sealing for later use.

7. The method according to claim 6, wherein the gypsum powder added in step S4 is added to form gypsum powder during the decoction.

8. The method according to claim 6, wherein the boiling time in step S1 is 1-1.5 hours, the boiling time in S2 is 0.5-1.0 hours, the boiling time in S4 is 1.5-2.0 hours, and the boiling time in S5 is 1/6-1/3 hours.

9. The method according to claim 8, wherein the boiling time in step S1 is 1 hour, the boiling time in step S2 is 0.5 hour, the boiling time in step S4 is 1.5 hours, and the boiling time in step S5 is 1/6 hours.

10. The preparation method of the traditional Chinese medicine preparation according to claim 6, wherein the preparation method comprises the following steps:

s1: taking 1100 parts of sesame oil, putting the sesame oil into a pot, decocting, taking 80 parts of carbonized hair, and putting the carbonized hair into the pot;

s2: taking out the carbonized hair after boiling, grinding, and obtaining the carbonized hair paste after the carbonized hair is in a paste form;

s3: taking 135 parts of tortoise plastron, putting the tortoise plastron into a fragrant oil pot, decocting until the color of chestnut skin is achieved, adding 600 parts of sesame oil, taking 125 parts of raw rehmannia root, decocting until the color of scorched color is achieved, adding 100 parts of Chinese angelica and 100 parts of lithospermum, decocting until the color is achieved, filtering, removing dregs, and decocting with slow fire;

s4: 400 parts of sesame oil is taken and put into the sesame oil pot, 320 parts of calamine powder, 635 parts of gypsum powder and 120 parts of cuttlebone powder are added, and then the mixture is boiled with slow fire;

s5: taking a pot, putting 950 parts of yellow wax and 950 parts of white wax into the pot, decocting until no foam exists, filtering the materials in a sesame oil pot by using gauze, and extinguishing the fire after decoction;

s6: continuously stirring until the temperature is reduced to a preset temperature range, adding the residual blood paste and 50 parts of dragon's blood, uniformly stirring to form paste, bottling and sealing for later use.