CN111529613A

CN111529613A - Diabetic foot medicament and preparation method and application thereof

Info

Publication number: CN111529613A
Application number: CN202010400434.6A
Authority: CN
Inventors: 郭方; 陈峻崧; 刘毅
Original assignee: Jiangsu Meideyu Medical Technology Co ltd
Current assignee: Jiangsu Meideyu Medical Technology Co ltd
Priority date: 2020-05-13
Filing date: 2020-05-13
Publication date: 2020-08-14

Abstract

The invention provides a diabetic foot medicament, which consists of main medicaments and auxiliary materials, wherein the main medicaments comprise the following raw materials: radix Sophorae Flavescentis, radix astragali, sanguis Draxonis, colla Corii Asini, and Borneolum Syntheticum; the mass ratio of the main medicine to the auxiliary materials is (2-5): 100. the traditional Chinese medicine has the effects of promoting blood circulation to remove blood stasis, removing necrotic tissue and promoting tissue regeneration, sterilizing and diminishing inflammation, improving microcirculation and achieving the purpose of healing ulcer. The medicine has good curative effect and no toxic and side effect when being used for local treatment. The preparation method is simple and easy to master, the raw materials are convenient to obtain, the price is low, and the curative effect is reliable.

Description

Diabetic foot medicament and preparation method and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, and particularly relates to a diabetic foot medicament and a preparation method and application thereof.

Background

The diabetic foot is a serious complication of diabetes, is one of the important reasons for disability and even death of the diabetic patient, causes pain to the patient and adds huge economic burden to the patient. According to incomplete statistics, diabetic foot ulcers account for about 20%.

The foot of the diabetic has the problem that the lower limb protection function is reduced due to neuropathy, and the diabetic foot is easy to occur due to microcirculation disturbance caused by insufficient arterial perfusion caused by macrovascular and microvascular lesions. Where sensory neuropathy combined with excessive mechanical stress is a major initiating factor in causing foot ulcers and infections. Inflammation and tissue damage are the result of a certain degree of repetitive stress on a particular area of loss of sensation. Pressure or shear forces from the ground, shoes, or other adjacent toes result in the formation of ulcers, which are often exacerbated by the presence of bony processes due to the lack of normal neuroprotective mechanisms. Lesions of the autonomic nervous system cause loss of the normal perspiration regulation function, skin temperature regulation function and blood transport regulation function of the skin, resulting in reduced flexibility of local tissues, formation of thick calluses and more susceptibility to breakage and cracking. In addition, the loss of normal perspiration blocks the rehydration of local tissues, causing further destruction of tissues, making deep tissues more susceptible to bacterial colonization. Motor neuropathy also plays a role in the development of diabetic feet, where contractures of intrinsic muscles of the foot cause typical claw-toe deformities. Hyperextension of the metatarsophalangeal joint has also been shown to directly increase the pressure under the metatarsal heads, making the area more prone to ulceration. Flexion of the proximal interphalangeal joint increases the risk of ulcers forming on the dorsal side of the prominent interphalangeal joint and on the plantar side of the toe, while vascular lesions make healing of the damaged tissue difficult.

Aerosol is a preparation which contains medicine, emulsion or suspension and proper propellant, and is packaged in a pressure-resistant container with a special valve system, and when in use, the content is sprayed out in the form of mist under the pressure of the propellant, and the aerosol is used for lung inhalation or directly sprayed to mucosa, skin and space of cavity and tract for disinfection. At present, no aerosol or atomized liquid medicine for treating diabetic foot is available on the market.

Disclosure of Invention

The invention aims to provide a diabetic foot medicament, a preparation method and application thereof, and the medicament has the effects of promoting blood circulation to remove blood stasis, removing putrefaction and promoting granulation, sterilizing and diminishing inflammation, and improving microcirculation, and achieves the purpose of healing ulcer.

The technical scheme of the invention is realized as follows:

the invention provides a diabetic foot medicament, which consists of main medicaments and auxiliary materials, wherein the main medicaments comprise the following raw materials: radix Sophorae Flavescentis, radix astragali, sanguis Draxonis, colla Corii Asini, and Borneolum Syntheticum; the mass ratio of the main medicine to the auxiliary materials is (2-5): 100.

as a further improvement of the invention, the main drug is prepared from the following raw materials in parts by weight: 1-5 parts of radix sophorae flavescentis, 1-5 parts of astragalus membranaceus, 5-10 parts of dragon's blood, 2-7 parts of donkey-hide gelatin and 0.5-1.5 parts of borneol.

As a further improvement of the invention, the main drug is prepared from the following raw materials in parts by weight: 3 parts of sophora flavescens, 3 parts of astragalus, 7 parts of dragon's blood, 5 parts of donkey-hide gelatin and 1 part of borneol.

As a further improvement of the invention, the auxiliary materials comprise glycerin, polysorbate-80, sodium citrate, citric acid, benzalkonium chloride, microcrystalline cellulose-sodium carboxymethyl cellulose and purified water.

As a further improvement of the invention, the auxiliary material is prepared from the following raw materials in parts by weight: 1-5 parts of glycerin, 801-3 parts of polysorbate, 0.1-0.5 part of sodium citrate, 0.1-0.3 part of citric acid, 0.01-0.05 part of benzalkonium chloride, 1-3 parts of microcrystalline cellulose-sodium carboxymethylcellulose and 80-95 parts of purified water.

As a further improvement of the invention, the auxiliary material is prepared from the following raw materials in parts by weight: 2.6 parts of glycerin, 801.8 parts of polysorbate, 0.3 part of sodium citrate, 0.2 part of citric acid, 0.02 part of benzalkonium chloride, 2 parts of microcrystalline cellulose-sodium carboxymethylcellulose and 90 parts of purified water.

As a further improvement of the invention, the medicament is an aerosol or an atomized liquid medicament.

The invention further provides a preparation method of the diabetic foot medicament, which comprises the following steps:

s1, preparing a dragon blood dispersion: dissolving dragon's blood with a proper amount of 90-95 wt% ethanol until the dragon's blood is completely dissolved, adding polysorbate-80, stirring uniformly, and volatilizing 95% ethanol to obtain a dragon's blood dispersion;

s2, uniformly mixing the astragalus extract with a proper amount of pure water, and melting the donkey-hide gelatin at 55-60 ℃ by adding the pure water to form a donkey-hide gelatin aqueous solution; mixing the two water solutions uniformly, adding polysorbate-80, and continuously stirring uniformly; dissolving Borneolum in glycerol at a temperature not higher than 40 deg.C, adding into the above mixture, stirring, adding sodium citrate, citric acid and microcrystalline cellulose-carboxymethylcellulose sodium, mixing, adding sanguis Draxonis dispersion, stirring, and cooling to room temperature;

s3, adding the sophora flavescens extract into the mixed liquor obtained in the step S2, adding benzalkonium chloride, stirring to form a suspension, and filling to obtain the sophora flavescens extract;

the donkey-hide gelatin is crushed into powder of 100 meshes; the borneol is treated in a jet milling mode; the astragalus extract and the sophora flavescens extract are respectively extracted by alcohol and water to obtain extractum, and are prepared by the following steps: extracting radix astragali or radix Sophorae Flavescentis twice with 8 times of 75% ethanol, extracting the residue with 6 times of water for three times to obtain ethanol extract and water extract, and mixing.

The invention further protects the application of the medicament in medicaments for treating or assisting in treating the diabetic foot.

The prescription of diabetic foot medicament is a Chinese medicinal compound formed from 5 Chinese medicinal materials of flavescent sophora root, astragalus root, dragon's blood, ass-hide glue and borneol, etc. The whole formula takes the sophora flavescens as the monarch, and the sophora flavescens has the effects of clearing heat, promoting diuresis, resisting bacteria, diminishing inflammation and treating skin itch; astragalus root, radix astragali, sweet in flavor and slightly warm in nature, is the essential herb for invigorating qi and promoting tissue regeneration, and is the top grade for expelling toxin and relieving swelling. The donkey-hide gelatin and the dragon blood are sweet and neutral products and have the functions of enriching blood and promoting tissue regeneration, wherein the donkey-hide gelatin is good for enriching blood and nourishing yin, the dragon blood is an essential medicine for treating unhealed ulcer, and the three medicines are ministerial medicines together; borneol, radix et rhizoma Rhei, radix Angelicae sinensis, radix Paeoniae alba. The six medicines of the whole formula have the effects of clearing heat and removing toxicity, removing putrefaction and promoting granulation, and tonifying qi and benefiting blood. The ointment is an oily matrix ointment or a water-soluble matrix ointment which is commonly used clinically and takes lanolin, vaseline and the like as main matrixes, no aerosol or atomized medicament is available on the market at present, the aerosol or atomized medicament has uniform application dosage, does not need hands to directly touch the skin, can directly reach an action part or an absorption part, has very obvious quick-acting action and positioning action, can keep clean and sterile state after being packaged in a closed container, reduces the chance of pollution of the medicament, has the advantages of difficult environmental pollution caused by residual medicament after stopping, and the like, and therefore, the ointment is necessary to be developed into the aerosol or atomized liquid medicine.

The invention has the following beneficial effects: the traditional Chinese medicine has the effects of promoting blood circulation to remove blood stasis, removing necrotic tissue and promoting tissue regeneration, sterilizing and diminishing inflammation, improving microcirculation and achieving the purpose of healing ulcer. The medicine has good curative effect and no toxic and side effect when being used for local treatment. The preparation method is simple and easy to master, the raw materials are convenient to obtain, the price is low, and the curative effect is reliable.

The invention is mainly used for treating diabetic foot, bedsore and chronic skin ulcer caused by various reasons, and is suitable for being popularized in hospitals, communities and families.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.

FIG. 1 is a flow chart of the preparation process of the diabetic foot medicament of the invention.

Detailed Description

For further explanation, the present invention is provided so that those skilled in the art can clearly understand the gist of the present invention. It should be noted that the following embodiments are not intended to limit the technical solutions of the present invention, and those skilled in the art can analyze and understand the embodiments and make a series of modifications and equivalent substitutions on the technical solutions provided by the present invention in combination with the prior knowledge, and the new technical solutions obtained by the modifications and equivalent substitutions are also included in the present invention.

Since the present invention cannot be exhaustive, some preferred features and preferred embodiments may be reasonably replaced or combined with each other, and thus the new embodiments are also encompassed by the present invention.

For the reader to better understand the subject matter of the present invention, a series of experimental data are specifically exemplified. The reader should have the general technical knowledge in the field when reading to facilitate an accurate understanding of the logical relationships included in the data.

Pulverizing colla Corii Asini into 100 mesh powder.

The borneol is treated by adopting an air flow crushing mode.

The astragalus extract and the sophora flavescens extract are extracted by alcohol and water step by step to obtain extractum, and the astragalus extract and the sophora flavescens extract are prepared by the following steps: extracting radix astragali or radix Sophorae Flavescentis twice with 8 times of 75% ethanol, extracting the residue with 6 times of water for three times to obtain ethanol extract and water extract, and mixing.

The raw material sources are as follows:

dragon's blood (Guangxi institute of traditional Chinese medicine, lot number 120525);

astragalus root, borneol, flavescent sophora root (Shanghai kang Qiao Chinese medicine decoction pieces limited company, batch numbers 110720, 101012, 120424);

colla Corii Asini (Shandong Huaxin pharmaceutical Co., Ltd., lot number 20110116);

glycerin (national drug group chemical agents limited, lot number 20120230);

polysorbate-80 (national pharmaceutical group chemical agents limited, lot number 20210650);

sodium citrate (Nanjing Willd chemical Co., Ltd., lot No. 20101101);

citric acid (Nanjing Willd chemical Co., Ltd., lot No. 20120209);

benzalkonium chloride (Nanjing Willd. chemical Co., Ltd., lot No. 20120203);

microcrystalline cellulose-sodium carboxymethylcellulose (national chemical group, ltd., lot No. 20120712).

Example 1

The raw materials comprise the following components in parts by weight:

main drugs: 1 part of radix sophorae flavescentis, 1 part of astragalus membranaceus, 5 parts of dragon's blood, 2 parts of donkey-hide gelatin and 0.5 part of borneol;

auxiliary materials: 1 part of glycerin, 801 parts of polysorbate, 0.1 part of sodium citrate, 0.1 part of citric acid, 0.01 part of benzalkonium chloride, 1 part of microcrystalline cellulose-sodium carboxymethylcellulose and 80 parts of purified water;

the mass ratio of the main medicine to the auxiliary materials is 2: 100.

the preparation method comprises the following steps:

s1, preparing a dragon blood dispersion: dissolving sanguis Draxonis with 90 wt% ethanol, adding polysorbate-80, stirring, and volatilizing 95% ethanol to obtain sanguis Draxonis dispersion;

s2, uniformly mixing the astragalus extract with a proper amount of pure water, and melting the donkey-hide gelatin at 55 ℃ by adding the pure water to form a donkey-hide gelatin aqueous solution; mixing the two water solutions uniformly, adding polysorbate-80, and continuously stirring uniformly; dissolving Borneolum in glycerol at a temperature not higher than 40 deg.C, adding into the above mixture, stirring, adding sodium citrate, citric acid and microcrystalline cellulose-carboxymethylcellulose sodium, mixing, adding sanguis Draxonis dispersion, stirring, and cooling to room temperature;

s3, adding the sophora flavescens extract into the mixed liquor obtained in the step S2, adding benzalkonium chloride, stirring to form a suspension, and filling to obtain the sophora flavescens extract.

Example 2

The raw materials comprise the following components in parts by weight:

main drugs: 5 parts of radix sophorae flavescentis, 5 parts of astragalus membranaceus, 10 parts of dragon's blood, 7 parts of donkey-hide gelatin and 1.5 parts of borneol;

auxiliary materials: 5 parts of glycerin, 803 parts of polysorbate, 0.5 part of sodium citrate, 0.3 part of citric acid, 0.05 part of benzalkonium chloride, 3 parts of microcrystalline cellulose-sodium carboxymethylcellulose and 95 parts of purified water;

the mass ratio of the main medicine to the auxiliary materials is 5: 100.

the preparation method comprises the following steps:

s1, preparing a dragon blood dispersion: dissolving sanguis Draxonis with appropriate amount of 95 wt% ethanol, adding polysorbate-80, stirring, and volatilizing 95% ethanol to obtain sanguis Draxonis dispersion;

s2, uniformly mixing the astragalus extract with a proper amount of pure water, adding the pure water into the donkey-hide gelatin, and melting at 60 ℃ to form a donkey-hide gelatin aqueous solution; mixing the two water solutions uniformly, adding polysorbate-80, and continuously stirring uniformly; dissolving Borneolum in glycerol at a temperature not higher than 40 deg.C, adding into the above mixture, stirring, adding sodium citrate, citric acid and microcrystalline cellulose-carboxymethylcellulose sodium, mixing, adding sanguis Draxonis dispersion, stirring, and cooling to room temperature;

Example 3

The raw materials comprise the following components in parts by weight:

main drugs: 2 parts of radix sophorae flavescentis, 2 parts of astragalus membranaceus, 6 parts of dragon's blood, 3 parts of donkey-hide gelatin and 0.7 part of borneol;

auxiliary materials: 2 parts of glycerin, 801.5 parts of polysorbate, 0.2 part of sodium citrate, 0.15 part of citric acid, 0.02 part of benzalkonium chloride, 1.5 parts of microcrystalline cellulose-sodium carboxymethylcellulose and 82 parts of purified water;

the mass ratio of the main medicine to the auxiliary materials is 3: 100.

the preparation method comprises the following steps:

s1, preparing a dragon blood dispersion: dissolving sanguis Draxonis with 92 wt% ethanol, adding polysorbate-80, stirring, and volatilizing 95% ethanol to obtain sanguis Draxonis dispersion;

s2, uniformly mixing the astragalus extract with a proper amount of pure water, and melting the donkey-hide gelatin at 56 ℃ by adding the pure water to form a donkey-hide gelatin aqueous solution; mixing the two water solutions uniformly, adding polysorbate-80, and continuously stirring uniformly; dissolving Borneolum in glycerol at a temperature not higher than 40 deg.C, adding into the above mixture, stirring, adding sodium citrate, citric acid and microcrystalline cellulose-carboxymethylcellulose sodium, mixing, adding sanguis Draxonis dispersion, stirring, and cooling to room temperature;

Example 4

The raw materials comprise the following components in parts by weight:

main drugs: 4 parts of radix sophorae flavescentis, 4 parts of astragalus membranaceus, 9 parts of dragon's blood, 6 parts of donkey-hide gelatin and 1.2 parts of borneol;

auxiliary materials: 4 parts of glycerin, 802.5 parts of polysorbate, 0.4 part of sodium citrate, 0.25 part of citric acid, 0.04 part of benzalkonium chloride, 2.5 parts of microcrystalline cellulose-sodium carboxymethylcellulose and 90 parts of purified water;

the mass ratio of the main medicine to the auxiliary materials is 4: 100.

the preparation method comprises the following steps:

s1, preparing a dragon blood dispersion: dissolving sanguis Draxonis with 94 wt% ethanol, adding polysorbate-80, stirring, and volatilizing 95% ethanol to obtain sanguis Draxonis dispersion;

s2, uniformly mixing the astragalus extract with a proper amount of pure water, adding the pure water into the donkey-hide gelatin, and melting at 59 ℃ to form a donkey-hide gelatin aqueous solution; mixing the two water solutions uniformly, adding polysorbate-80, and continuously stirring uniformly; dissolving Borneolum in glycerol at a temperature not higher than 40 deg.C, adding into the above mixture, stirring, adding sodium citrate, citric acid and microcrystalline cellulose-carboxymethylcellulose sodium, mixing, adding sanguis Draxonis dispersion, stirring, and cooling to room temperature;

Example 5

The raw materials comprise the following components in parts by weight:

main drugs: 3 parts of radix sophorae flavescentis, 3 parts of astragalus membranaceus, 7 parts of dragon's blood, 5 parts of donkey-hide gelatin and 1 part of borneol;

auxiliary materials: 2.6 parts of glycerin, 801.8 parts of polysorbate, 0.3 part of sodium citrate, 0.2 part of citric acid, 0.02 part of benzalkonium chloride, 2 parts of microcrystalline cellulose-sodium carboxymethylcellulose and 90 parts of purified water;

the mass ratio of the main medicine to the auxiliary materials is 3.5: 100.

the preparation method comprises the following steps:

s1, preparing a dragon blood dispersion: dissolving sanguis Draxonis with 93 wt% ethanol, adding polysorbate-80, stirring, and volatilizing 95% ethanol to obtain sanguis Draxonis dispersion;

s2, uniformly mixing the astragalus extract with a proper amount of pure water, adding pure water into the donkey-hide gelatin, and melting at 57 ℃ to form a donkey-hide gelatin aqueous solution; mixing the two water solutions uniformly, adding polysorbate-80, and continuously stirring uniformly; dissolving Borneolum in glycerol at a temperature not higher than 40 deg.C, adding into the above mixture, stirring, adding sodium citrate, citric acid and microcrystalline cellulose-carboxymethylcellulose sodium, mixing, adding sanguis Draxonis dispersion, stirring, and cooling to room temperature;

Test example 1

1 materials and methods

1.1 experimental animals SPF grade SD rats 40 male, age 4 weeks, body weight 180 + -12 g, provided by Experimental animals center of pharmaceutical university in Shanghai, Experimental animals license number: SYXK (Shanghai) 2019-0010; feeding conditions are as follows: the temperature is 22 deg.C, the humidity is 65%, and the feed can be freely drunk, and can be used for common feed and high fat feed (purchased from Experimental animals center of Shanghai medical university).

1.2 pharmaceutical agents the diabetic foot preparation of this invention, example 5, was prepared.

1.3 animal models and group interventions

After 40 SD rats are adaptively raised for 1 week, 10 non-diabetic ulcer groups (NU) are randomly selected and fed by common feed; after feeding the rest 24 SD rats with high-fat feed for 8 weeks, injecting streptozotocin solution into abdominal cavity according to the dose of 35mg/kg of experimental rat weight, wherein the blood sugar is more than 16.7mmol/L after 24 hours of injection, and the blood sugar is still more than 16.7mmol/L after 3 days of measurement, and preparing the model of diabetes. Using SQL-5Q scald apparatus, temperature is 90 deg.C, contact time is 10s, pressure is 9.8N, area is 4cm²And after anesthesia, the skin of the back is scalded to complete the establishment of the non-diabetic ulcer model and the diabetic non-ischemic ulcer model. The non-diabetic ulcer and the diabetic non-ischemic ulcer model are burned and molded simultaneously. The SD rats with diabetic ulcer successfully molded are randomly divided into diabetic ulcer blank control groups (D)U1), diabetic ulcer beifuji group (DU2), diabetic ulcer example 5 diabetic foot pharmaceutical group (DU 3). Diabetic ulcer example 5 diabetic foot medicament was used in the diabetic foot medicament group, Befuji was used in the diabetic ulcer Befuji group, and the diabetic ulcer blank control group and the non-diabetic ulcer group were not treated with the drugs and were directly covered with gauze. The dressing change was performed once a day with an observation period of 15 days. After the model is successfully made (before medication), blood is taken from the orbit of the rat and serum is separated; after 15 days of administration (after administration), the rats were sacrificed after fasting for 12 hours the day before, blood was taken, and the ulcer area was measured.

1.4 ulcer healing Rate

The ulcer healing rate (NU) of the 15-day diabetic ulcer blank control group (DU1), diabetic ulcer Beiji group (DU2), diabetic ulcer example 5 diabetic foot medicament group (DU3) and non-diabetic ulcer group were compared. Selecting the clearest picture, drawing the outline of the clearest picture along the ulcer edge by using a tracing pen by using Image J medical Image analysis software (Image J-ij 133-jdk 15, national institutes of health, USA), and calculating the pixel area; drawing a 1cm line segment on the scale with a tracing pen, measuring the pixel value of the 1cm line segment, and calculating the 1cm line segment²The pixel area of (a); pixel area of ulcer surface contour divided by 1cm²Area of pixels (g) is ulcer surface area the percentage of healed area to initial ulcer area is ulcer healing rate [ (% ulcer healing rate) [ (% initial ulcer area-area of post-dose ulcer)/initial ulcer area × 100 ]

1.5 statistical treatment

Statistics were performed using SPSS19.0ForWindows software. The measurement data are expressed by (x +/-s), the counting data are expressed by a composition ratio, the measurement data are subjected to normal distribution and uniform variance, the comparison among groups adopts one-factor variance analysis, and the comparison in the groups adopts t test; if the variance is not uniform, correcting the variance, and then carrying out variance analysis; if the distribution is not in accordance with normal distribution, non-parametric test is adopted.

2 results

2.1 ulcer healing Rate results are shown in Table 1.

TABLE 1

Group of	n	Ulcer healing Rate (%)
			DU1	10	82.01±2.33
DU2	10	85.82±3.10^**
			DU3	10	95.24±3.81^**##
NU	10	96.12±1.83^**##

Note that: p <0.01 compared to the blank control group (DU 1); # is P <0.01 compared to Behcet (DU 2).

After 15 days of administration, the healing rate of the diabetic ulcer blank control group (DU1) is 82.01 +/-2.33 (%), the healing rate of the diabetic ulcer Beifuji group (DU2) is 85.82 +/-3.10 (%), the healing rate of the diabetic ulcer example 5 diabetic foot medicament group (DU3) is 95.24 +/-3.81 (%), and the healing rate of the non-diabetic ulcer group (NU) is 96.12 +/-1.83 (%). The non-diabetic ulcer group (NU) healed the highest rate, which was significantly higher than the placebo group (DU1) (P < 0.01) and the Behcet group (DU2) (P < 0.01). Diabetic ulcer example 5 the healing rate of the diabetic foot dose group (DU3) was significantly higher than that of the placebo group (DU1) (P < 0.01) and the Beifuji group (DU2) (P < 0.01), with the Beifuji group (DU2) being significantly higher (P < 0.01) than the placebo group (DU 1).

Compared with the prior art, the traditional Chinese medicine has the effects of promoting blood circulation to remove blood stasis, removing putrefaction and promoting tissue regeneration, sterilizing and diminishing inflammation, improving microcirculation and achieving the purpose of healing ulcer. The medicine has good curative effect and no toxic and side effect when being used for local treatment. The preparation method is simple and easy to master, the raw materials are convenient to obtain, the price is low, and the curative effect is reliable.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims

1. The diabetic foot medicament is characterized by consisting of a main medicament and auxiliary materials, wherein the main medicament comprises the following raw materials: radix Sophorae Flavescentis, radix astragali, sanguis Draxonis, colla Corii Asini, and Borneolum Syntheticum; the mass ratio of the main medicine to the auxiliary materials is (2-5): 100.

2. the diabetic foot medicament as claimed in claim 1, wherein the main medicament is prepared from the following raw materials in parts by weight: 1-5 parts of radix sophorae flavescentis, 1-5 parts of astragalus membranaceus, 5-10 parts of dragon's blood, 2-7 parts of donkey-hide gelatin and 0.5-1.5 parts of borneol.

3. The diabetic foot medicament as claimed in claim 2, wherein the main medicament is prepared from the following raw materials in parts by weight: 3 parts of sophora flavescens, 3 parts of astragalus, 7 parts of dragon's blood, 5 parts of donkey-hide gelatin and 1 part of borneol.

4. The diabetic foot medicament of claim 1, wherein the excipients comprise glycerin, polysorbate-80, sodium citrate, citric acid, benzalkonium chloride, microcrystalline cellulose-sodium carboxymethylcellulose, purified water.

5. The diabetic foot medicament according to claim 4, wherein the auxiliary material is prepared from the following raw materials in parts by weight: 1-5 parts of glycerin, 801-3 parts of polysorbate, 0.1-0.5 part of sodium citrate, 0.1-0.3 part of citric acid, 0.01-0.05 part of benzalkonium chloride, 1-3 parts of microcrystalline cellulose-sodium carboxymethylcellulose and 80-95 parts of purified water.

6. The diabetic foot medicament according to claim 5, wherein the auxiliary material is prepared from the following raw materials in parts by weight: 2.6 parts of glycerin, 801.8 parts of polysorbate, 0.3 part of sodium citrate, 0.2 part of citric acid, 0.02 part of benzalkonium chloride, 2 parts of microcrystalline cellulose-sodium carboxymethylcellulose and 90 parts of purified water.

7. The diabetic foot medicament of claim 1, wherein the medicament is an aerosol or a nebulized liquid medicament.

8. A process for the preparation of a diabetic foot medicament according to any of claims 1 to 7 comprising the steps of:

9. Use of the agent of claims 1-7 in a medicament for the treatment or co-treatment of diabetic foot.