Traditional Chinese medicine composition for treating drug-resistant bacteria diabetic foot ulcer and application thereof

Abstract

The invention provides a pharmaceutical composition for drug-resistant bacteria diabetic foot ulcer. The pharmaceutical composition comprises the following medicinal components: ampelopsis japonica, salvia miltiorrhiza, golden larch bark, arisaema cum bile, astragalus membranaceus, honeysuckle, erythrina bark, purslane, scutellaria baicalensis, bletilla striata, dragon's blood, dandelion and garden balsam stem. The invention further provides a pharmaceutical preparation containing the pharmaceutical composition and application of the pharmaceutical preparation in preparation of drugs for treating drug-resistant bacteria diabetic foot ulcer. The pharmaceutical composition and the preparation thereof can effectively improve drug-resistant bacteria diabetic foot ulcer, are good in safety, ensure that the liver function and the kidney function of a patient are in a normal range, and have no adverse reaction.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition for treating drug-resistant bacteria diabetic foot ulcers and an application thereof. Background Art

[0002] Since the wound of diabetic foot ulcer is directly exposed to the body surface and does not heal for a long time, it is very easy to get infected during the course of the disease. Infection will also cause the ulcer to be stimulated by local inflammatory exudates, and the formation of granulation tissue on the wound surface is often inhibited, which hinders the penetration of the effective ingredients of topical preparations into the lesion tissue, making it more difficult to heal. For foot ulcers, anti-infection is one of the important treatments, but with the long-term and partial irregular use of broad-spectrum antibacterial drugs, it is easy to induce bacterial resistance. Multidrug-resistant (MDR) infection usually increases the morbidity and mortality of the disease. If a large amount of topical antibiotics are used, it often leads to bacterial mutation and accelerates the process of bacterial resistance. Diabetic foot ulcer belongs to the category of sore disease in traditional Chinese medicine surgery. Traditional Chinese medicine treatment has also accumulated a certain amount of clinical application and basic research on intervention of multidrug-resistant wounds.

[0003] Traditional Chinese medicine has the advantages of diverse ingredients, rich resources, relatively low prices, excellent antibacterial efficacy, fewer toxic side effects, and high safety. During the treatment process of traditional Chinese medicine, it can control bacterial growth through multiple targets and pathways and restore the bactericidal efficacy of antibiotics, becoming one of the important ways to control infection and avoid irrational use of antibiotics during treatment. Summary of the invention

[0004] In order to solve the above problems, the present invention provides a Chinese medicine composition for treating drug-resistant diabetic foot ulcers and its application. The Chinese medicine composition for treating drug-resistant diabetic foot ulcers provided by the present invention can protect the wound and remove the pathogen under the guidance of traditional Chinese medicine theory, reduce the load of drug-resistant bacteria, and is used to treat diabetic foot wounds accompanied by drug-resistant bacteria infection.

[0005] In order to achieve the above object, the present invention provides the following technical solutions:

[0006] The present invention provides a traditional Chinese medicine composition for treating drug-resistant diabetic foot ulcers, which is prepared from the following raw materials in parts by weight:

[0007] 15-35 parts of white smilax china; 10-25 parts of salvia miltiorrhiza; 15-30 parts of scutellaria baicalensis; 4-26 parts of arisaema ciliata;

[0008] 10-25 parts of Astragalus; 10-25 parts of Honeysuckle; 4-27 parts of Pittosporum tobira bark; 15-35 parts of Portulaca oleracea;

[0009] 6-26 parts of Scutellaria baicalensis; 5-30 parts of Bletilla striata; 10-35 parts of Sanguisorba officinalis; 10-40 parts of Taraxacum officinale;

[0010] 5-25 parts of Herba Polygoni Multiflori.

[0011] Preferably, the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0012] 20-35 parts of white smilax china; 10-25 parts of salvia miltiorrhiza; 20-30 parts of scutellaria baicalensis; 6-20 parts of arisaema;

[0013] 10-25 parts of Astragalus; 15-20 parts of Honeysuckle; 6-20 parts of Pittosporum tobira bark; 15-25 parts of Portulaca oleracea;

[0014] 15-25 parts of Scutellaria baicalensis; 10-18 parts of Bletilla striata; 15-25 parts of Sanguisorba officinalis; 25-35 parts of Taraxacum officinale;

[0015] 6-20 parts of Herba Polygoni Multiflori.

[0016] More preferably, the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0017] 20 parts of Radix Bletillae; 25 parts of Radix Salviae Miltiorrhizae; 20 parts of Cortex Psoraleae; 20 parts of Arisaema Cum Bile;

[0018] 25 parts of Astragalus; 20 parts of Honeysuckle; 6 parts of Pittosporum tobira bark; 20 parts of Portulaca oleracea;

[0019] 15 parts of Scutellaria baicalensis; 13 parts of Bletilla striata; 25 parts of Sanguisorba officinalis; 25 parts of Taraxacum mongolicum; 6 parts of Herba speranskiae radix;

[0020] More preferably, the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0021] 35 parts of Radix Bletillae; 10 parts of Radix Salviae Miltiorrhizae; 30 parts of Cortex Psoraleae; 6 parts of Rhizoma Arisaematis;

[0022] 15 parts of Astragalus; 15 parts of Honeysuckle; 10 parts of Pittosporum tobira bark; 15 parts of Portulaca oleracea;

[0023] 25 parts of Scutellaria baicalensis, 18 parts of Bletilla striata, 15 parts of Sanguisorba officinalis, 35 parts of Taraxacum mongolicum, and 11 parts of Herba speranskiae radix.

[0024] More preferably, the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0025] 20 parts of Radix Bletillae; 20 parts of Radix Salviae Miltiorrhizae; 20 parts of Cortex Psoraleae; 10 parts of Rhizoma Arisaematis;

[0026] 20 parts of Astragalus; 10 parts of Honeysuckle; 23 parts of Pittosporum tobira bark; 25 parts of Portulaca oleracea;

[0027] 15 parts of Scutellaria baicalensis; 7 parts of Bletilla striata; 20 parts of Sanguisorba officinalis; 25 parts of Taraxacum mongolicum; 25 parts of Herba speranskiae radix;

[0028] Preferably, the dosage form of the Chinese medicine composition is tincture.

[0029] The present invention also provides a tincture suitable for the above-mentioned traditional Chinese medicine composition, and the tincture comprises the above-mentioned traditional Chinese medicine composition and a solvent.

[0030] Preferably, the solvent is ethanol.

[0031] The present invention also provides a preparation method of the above tincture, comprising the following steps: taking the above Chinese medicine raw materials and drying them appropriately, preparing coarse powder by dry mixing and crushing method, soaking them in medicinal ethanol for 1-3 weeks, stirring them 3-6 times a day, each time for 5-10 minutes, filtering and taking the filtrate, fully dissolving it with water, and then quantifying it by 75% ethanol aqueous solution, and making the alcohol content 45-55%, thereby obtaining the tincture.

[0032] Preferably, the mass ratio of the raw materials of the traditional Chinese medicine composition to medicinal ethanol is (1.5-2):4.

[0033] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition or the above-mentioned tincture or the tincture prepared by the above-mentioned preparation method in the preparation of treatment.

[0034] The medicine provided by the present invention is a botanical medicine, does not contain animal (insect) medicinal materials, reduces the cost of medication for patients, and has health economic significance. The present invention has no special restrictions on the above-mentioned raw materials, and conventional commercially available Chinese medicine raw materials well known to those skilled in the art can be used.

[0035] The Chinese medicine composition provided by the present invention is prepared from the following raw materials in parts by weight: Radix Bletillae, Radix Salviae Miltiorrhizae, Cortex Psoraleae, Rhizoma Aristolochiae, Radix Astragali, Flos Lonicerae, Cortex Pittosporume, Herba Portulacae, Radix Scutellariae, Rhizoma Bletillae, Herba Sanguisorbae, Herba Taraxaci, Herba Polygoni Multiflori. All the medicines are used together, under the guidance of the holistic concept, based on the treatment principle of "positive energy is stored inside, and evil cannot interfere", expelling evil and strengthening positive energy are carried out simultaneously, with qi and blood as the material basis, and protecting one's own positive energy. Protecting the field in a narrow sense refers to the range of degeneration and inflammation of the tissue around the sore surface formed by the positive energy restraining the evil energy in the struggle between the positive energy and the evil energy of the sore, so that it does not sink or spread. This drug combination can promote the formation of a local protective field on the wound surface. The liquid can gather and contract the sore. It can surround the lesion, the area invaded by evil qi, and the field where righteousness and evil fight against each other. It can surround and contract. Through the use of this drug combination to surround, if the evil qi is strong, it will be surrounded and gathered, moving deep to shallow; if the evil qi is weak, it will disappear, preventing the infection from sinking into or spreading. The evil qi is removed and the righteous qi is restored, achieving the dual purpose of maintaining the stability of the body and preventing secondary infection.

[0036] The Chinese medicine composition provided by the present invention has a rigorous composition, and the components interact with each other, promote each other, and play a role together. In particular, the medicinal flavors of Radix Ampelopsis, Cortex Psoraleae, Radix Scutellariae, Herba Taraxaci, etc. complement each other, and the combined use synergistically improves the inhibitory effect on drug-resistant bacteria. Experiments show that the Chinese medicine composition of the present invention can effectively inhibit the growth of drug-resistant bacteria, control the inflammatory reaction of the wound surface, remove toxins, discharge pus and rot, control infection, optimize the wound environment, shorten the treatment cycle, and effectively promote the healing of wounds of drug-resistant diabetic foot ulcers. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 : Patients’ family members taking photos at home;

[0038] Figure 2 : Wound secretion culture results: Pseudomonas aeruginosa (multi-drug resistant), postoperative application of the drug composition on the wound surface and peri-wound stains;

[0039] Figure 3 : The pharmaceutical composition of the present invention was applied after surgery to bind the poison and reduce swelling; the culture results of wound secretions were reviewed: no bacterial growth;

[0040] Figure 4 "Chronic ulcer repair + amputation of the 1st to 5th toes" repairs and trims the wound surface, continues to use this drug after surgery, and rechecks the wound secretion culture results: no bacterial growth composition;

[0041] Figure 5 : Intermittent closed negative pressure suction was used, combined with the drug composition to flush and exchange the secretions on the ulcer surface, to provide a way out for the evil and promote epithelial growth. Multiple reexaminations confirmed that the drug-resistant bacteria had been eliminated;

[0042] Figure 6 : The wound healed and the affected foot did not ulcerate again. DETAILED DESCRIPTION

[0043] The invention provides a traditional Chinese medicine composition for treating drug-resistant diabetic foot ulcers. The traditional Chinese medicine composition is prepared by comprising the following raw materials in parts by weight: 15-35 parts of white ampelopsis; 10-25 parts of salvia miltiorrhiza; 15-30 parts of thorn bark; 4-26 parts of arisaema; 10-25 parts of astragalus; 10-25 parts of honeysuckle; 4-27 parts of pittosporum tobira; 15-35 parts of purslane; 6-26 parts of scutellaria baicalensis; 5-30 parts of bletilla striata; 10-35 parts of blood clovers; 10-40 parts of dandelions; and 5-25 parts of radix spatholobi.

[0044] In the present invention, the Chinese medicine composition provided is preferably presented in the form of a tincture, and the Chinese medicine composition tincture refers to a clear liquid preparation made by extracting and dissolving medicinal materials with ethanol. After ethanol extraction, the tincture formed is less irritating, and the pharmaceutical composition can penetrate the skin and subcutaneous tissue under the action of ethanol dissolution, and play a role in promoting the disappearance of local infection. Clinical practice and evidence-based evidence suggest that the Chinese medicine composition has the effects of reducing swelling and dispersing congestion, improving the local sore surface microenvironment, reducing the load of drug-resistant bacteria, and promoting wound healing. For the treatment of drug-resistant diabetic foot, the tincture has clinical advantages such as portability and low sensitization in clinical application. At the same time, it has a definite effect on the control of bacterial load on the wound surface, and is easy to operate, with few adverse reactions, and the tincture can be organically, appropriately, and flexibly applied with a variety of treatment methods (such as wound or peri-wound wetting, liquid hoop, combined closed negative pressure suction equipment flushing, Chinese medicine bath soaking exchange, reducing bacterial load, etc.) in the repair process, which is convenient for clinical application and promotion.

[0045] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps: taking the above-mentioned Chinese medicine raw materials and drying them appropriately, preparing coarse powder by dry mixing and crushing method, soaking them in medicinal ethanol for 1-3 weeks, stirring them 3-6 times a day, each time for 5-10 minutes, filtering and taking the filtrate, fully dissolving them with water, and then quantifying them by 75% ethanol aqueous solution, and making the alcohol content 45-55%, thereby obtaining the obtained product.

[0046] In the present invention, the mass ratio of the raw materials of the Chinese medicine composition to the medicinal ethanol is (1.5-2):4, and more preferably 1.5:4. When applied, it is suitable to cover the entire lesion area, preferably to apply around the wound edge to 5 cm outside the lesion edge, and after application, the wound surface and the wound area are covered with sterile gauze and fixed with adhesive tape or bandage.

[0047] During the operation, pay attention to the temperature to prevent the temperature from being too low to cause insufficient drug strength, or too high to cause burns. It is better to keep it close to the skin temperature. Note that it is forbidden for those who are allergic to this drug combination, or those who are physically weak and cannot tolerate the above drugs or tinctures.

[0048] To further illustrate the present invention, a Chinese medicine composition for treating drug-resistant diabetic foot ulcers and its application provided by the present invention are described in detail below with reference to examples.

[0049] Embodiment 1:

[0050] The following raw materials are taken to prepare a traditional Chinese medicine composition: 20 parts of white ampelopsis; 25 parts of salvia miltiorrhiza; 20 parts of thorn bark; 20 parts of arisaema; 25 parts of astragalus; 20 parts of honeysuckle; 6 parts of pittosporum tobira; 20 parts of purslane; 15 parts of scutellaria baicalensis; 13 parts of bletilla striata; 25 parts of blood clotting; 25 parts of dandelion; 6 parts of radix spatholobi.

[0051] Example 1 is prepared according to the following preparation method: after the above-mentioned Chinese medicine raw materials are properly dried, they are made into coarse powder by dry mixing and crushing method, and soaked in medicinal ethanol for 1 week. The mass ratio of the raw materials of the Chinese medicine composition to the medicinal ethanol is 1.5:4. Stir 3-6 times a day, each time for 5-10 minutes. After filtering, take the filtrate, fully dissolve it with water, and then quantify it through 75% ethanol aqueous solution, and make the alcohol content 45%.

[0052] Embodiment 2:

[0053] The following raw materials are taken to prepare a traditional Chinese medicine composition: 15 parts of white ampelopsis; 15 parts of salvia miltiorrhiza; 15 parts of thorn bark; 15 parts of arisaema cinerea; 10 parts of astragalus; 20 parts of honeysuckle; 15 parts of pittosporum tobira; 35 parts of purslane; 10 parts of scutellaria baicalensis; 25 parts of bletilla striata; 35 parts of blood clotting; 15 parts of dandelion; 15 parts of radix spatholobi.

[0054] Example 2 is prepared according to the following preparation method: after the above-mentioned Chinese medicine raw materials are properly dried, they are made into coarse powder by dry mixing and crushing method, and soaked in medicinal ethanol for 1 week. The mass ratio of the raw materials of the Chinese medicine composition to the medicinal ethanol is 1.5:4. Stir 3-6 times a day, each time for 5-10 minutes. After filtering, take the filtrate, fully dissolve it with water, and then quantify it through 75% ethanol aqueous solution, and make the alcohol content 45%.

[0055] Embodiment 3:

[0056] The following raw materials are taken to prepare a traditional Chinese medicine composition: 35 parts of white ampel; 10 parts of salvia miltiorrhiza; 30 parts of thorn bark; 6 parts of arisaema; 15 parts of astragalus; 15 parts of honeysuckle; 10 parts of pittosporum tobira; 15 parts of purslane; 25 parts of scutellaria baicalensis; 18 parts of bletilla striata; 15 parts of blood clotting; 35 parts of dandelion; 11 parts of radix spatholobi.

[0057] Example 3 is prepared according to the following preparation method: after the above-mentioned Chinese medicine raw materials are properly dried, they are made into coarse powder by dry mixing and crushing method, and soaked in medicinal ethanol for 1 week. The mass ratio of the raw materials of the Chinese medicine composition to the medicinal ethanol is 1.5:4. Stir 3-6 times a day, each time for 5-10 minutes. After filtering, take the filtrate, fully dissolve it with water, and then quantify it through 75% ethanol aqueous solution, and make the alcohol content 45%.

[0058] Embodiment 4:

[0059] The following raw materials are taken to prepare a traditional Chinese medicine composition: 20 parts of white ampelopsis; 20 parts of salvia miltiorrhiza; 20 parts of thorn bark; 10 parts of arisaema; 20 parts of astragalus; 10 parts of honeysuckle; 23 parts of pittosporum tobira; 25 parts of purslane; 15 parts of scutellaria baicalensis; 7 parts of bletilla striata; 20 parts of blood clotting; 25 parts of dandelion; 25 parts of radix spatholobi.

[0060] Example 4 is prepared according to the following preparation method: after the above-mentioned Chinese medicine raw materials are properly dried, they are made into coarse powder by dry mixing and grinding method, and soaked in medicinal ethanol for 3 weeks, the mass ratio of the raw materials of the Chinese medicine composition to the medicinal ethanol is 1:2, and the mixture is stirred 3-4 times a day, each time for 5-6 minutes. After filtering, the filtrate is taken, fully dissolved with water, and then quantified by 75% ethanol aqueous solution, and the alcohol content is 55%.

[0061] Comparative Example 1:

[0062] The following raw materials were taken to prepare a Chinese medicine composition: 25 parts of Danshen; 30 parts of Echinochloa crus-galli; 20 parts of Arisaema cinerea; 25 parts of Astragalus; 20 parts of Honeysuckle; 6 parts of Pittosporum tobira; 20 parts of Portulaca oleracea; 20 parts of Scutellaria baicalensis; 13 parts of Bletilla striata; 25 parts of Sanguisorba officinalis; 30 parts of Taraxacum officinale; 6 parts of Herba speranskiae radix. Comparative Example 1 was prepared according to the preparation method of Example 1.

[0063] Comparative Example 2:

[0064] The following raw materials were taken to prepare a Chinese medicine composition: 30 parts of Radix Bletillae; 25 parts of Radix Salviae Miltiorrhizae; 20 parts of Rhizoma Arisaematis; 25 parts of Radix Astragali; 20 parts of Flos Lonicerae; 6 parts of Cortex Pittosporume; 20 parts of Portulaca Oleracea; 20 parts of Radix Scutellariae; 13 parts of Rhizoma Bletillae; 25 parts of Sanguisorba Officinalis; 30 parts of Taraxacum Herba; 6 parts of Herba Polygoni Multiflori. Comparative Example 2 was prepared according to the preparation method of Example 1.

[0065] Comparative Example 3:

[0066] The following raw materials were taken to prepare a Chinese medicine composition: 25 parts of Radix Bletillae; 25 parts of Radix Salviae Miltiorrhizae; 25 parts of Cortex Coptidis; 20 parts of Arisaema; 25 parts of Radix Astragali; 20 parts of Flos Lonicerae; 6 parts of Cortex Pittosporum; 20 parts of Portulaca Oleracea; 13 parts of Bletillae Striatae; 25 parts of Sanguisorba Officinalis; 30 parts of Taraxacum Herba; 6 parts of Herba Spermatophorae. Comparative Example 3 was prepared by referring to the preparation method of Example 1.

[0067] Comparative Example 4:

[0068] The following raw materials are prepared into a Chinese medicine composition: 25 parts of white peony root, 25 parts of salvia miltiorrhiza, 30 parts of thorn bark, 20 parts of arisaema, 25 parts of astragalus, 20 parts of honeysuckle, 6 parts of pittosporum tobira, 20 parts of purslane, 25 parts of scutellaria, 13 parts of bletilla striata, 25 parts of blood clotting, and 6 parts of radix schizonepetae. Comparative Example 4 is prepared according to the preparation method of Example 1.

[0069] Experiment 1: Antibacterial effect experiment

[0070] Test method: 1 mL, 1.5 mL and 2 mL of the preparations prepared in the above Examples 1-4 and Comparative Examples 1-4 were taken to form test groups, and sterile water was used as a blank control group. The antibacterial effect of each test group was tested by a conventional inhibition zone method. The average values ​​of each example, comparative example and blank control group were calculated, and the following experimental data were obtained:

[0071] Table 1 Antibacterial effect experiment

[0072]

[0073]

[0074] Note: “--” in the table means no inhibition zone.

[0075] As can be seen from Table 1, compared with the blank control group, Examples 1-4 and Comparative Examples 1-4 have certain antibacterial activity, among which the antibacterial effect of Examples 1-4 is better than that of Comparative Examples 1-4. Changing the composition of the formula will affect the antibacterial effect of the preparation. The components of the composition of the present application interact with each other, promote each other, and jointly exert antibacterial effects, especially the medicinal flavors such as Ampelopsis pilosula, Cortex chinensis, Radix Scutellariae, and Herba Taraxaci, which complement each other, and the combined use synergistically improves the inhibitory effect on drug-resistant bacteria.

[0076] Experiment 2: Clinical efficacy trial

[0077] The pharmaceutical composition prepared in Example 1 of the present invention was used to treat drug-resistant diabetic foot ulcers (experimental group), and calcium alginate silver fiber dressing was used as a positive control drug (control group).

[0078] 1 Treatment method:

[0079] (1) Control group: Take calcium alginate silver fiber dressing (size [10cm×10cm]) and cut it to a suitable size according to the size of the foot wound. Cover the wound locally with calcium alginate silver fiber dressing, then bandage it in the usual way and change it every 24 hours.

[0080] (2) Experimental group: The drug was applied to the wound surface and the peri-wound area (preferably around the wound edge to 5 cm outside the edge of the lesion) until 5 layers of sterile gauze were soaked, followed by routine bandage, which was changed every 24 hours.

[0081] There were 30 cases in the experimental group and 30 cases in the control group. The treatment period was 2 weeks. The cases were selected according to the following criteria:

[0082] Disease diagnostic criteria: Refer to the diagnostic criteria for DF in the "Guidelines for the Diagnosis and Treatment of Diabetic Foot in China" (2020 edition).

[0083] Diagnostic criteria for drug-resistant bacterial infection: refer to the diagnostic criteria of "Chinese Expert Consensus on Prevention and Control of Hospital Infection with Multidrug-Resistant Bacteria" (2015 edition) and "Interim Standard Definitions of MDR, XDR, and PDR Multidrug-Resistant Bacteria - International Expert Recommendations" (2014 edition).

[0084] Grading standards for diabetic foot infection: refer to the IDSA infection grading standard for diabetic foot infection developed by the Infectious Diseases Society of America.

[0085] In the basic treatment of the two groups, routine internal medicine basic treatment was implemented according to the "Guidelines for the Diagnosis and Treatment of Diabetic Foot in China" (2020 edition) (blood sugar control, blood pressure reduction, lipid regulation, antiplatelet and anticoagulant therapy, etc.) + routine surgical basic treatment (debridement and dressing change, etc.). Oral or intravenous use of antibiotics was prohibited during the study.

[0086] In order to ensure the consistency and standardization of operations, the key links of clinical external treatment standard operating procedures (SOP) have been formulated, as follows:

[0087] (1) After removing the outer dressing from the wound, use tweezers to remove the inner dressing;

[0088] (2) First, use sterile cotton wool to absorb the wound exudate, and then use iodine to disinfect the wound area or wound surface;

[0089] (3) Sharply and tensionlessly remove the liquefied and floating tendon and fascia tissues in the wound surface, and retain the tendons and fascia that have not yet necrotized;

[0090] (4) In the experimental group, the drug was applied to the wound surface and the peri-wound area (preferably around the wound edge to 5 cm outside the edge of the lesion) until 5 layers of sterile gauze were soaked, followed by routine bandage, which was changed every 24 hours.

[0091] In the control group, the wound was covered with calcium alginate silver fiber dressing, followed by routine bandage, which was changed every 24 hours.

[0092] Decompression and immobilization: During the entire trial, patient education was strengthened and patients were urged to use appropriate decompression methods, such as crutches, wheelchairs, orthotics, decompression insoles, etc., during necessary activities. During non-essential activities, patients were asked to apply relative immobilization to avoid worsening or spreading of infection.

[0093] This experiment uses the eKare inSight three-dimensional scanning program (eKare Inc., USA, specification: V1.12.2, batch number: 000354) for optical imaging. The 3D structured photosensitive technology of the low-energy infrared signal acquisition device is used to identify and track the specific position of the target in three-dimensional space. It works with the Apple iPad device and the Structure Sensor sensor, and calculates the required data based on different photoelectric codes to measure the depth and volume of the object, achieving non-destructive, real-time, dynamic and objective recording of changes in the wound surface. It has the advantages of high accuracy, convenient operation and high stability, forming a multi-dimensional efficacy evaluation indicator with a time perspective. In addition, the instrument has added interfaces such as information recording, image archiving, comparative evaluation, and patient management, realizing the integration of measurement and management, and realizing the integration of wound management.

[0094] 2 Effect evaluation

[0095] Wound related information

[0096] There was no significant difference in the wound-related assessment information ABI index, site of disease, and distribution of drug-resistant bacteria between the two groups (P>0.05). The baseline conditions of the wounds between the two groups were balanced and comparable, as shown in Table 1.

[0097] Table 2 Local wound assessment information

[0098]

[0099] 2.2 Statistical analysis of infection-related indicators before and after treatment is shown in Table 2.

[0100] Table 3 Analysis of infection-related indicators

[0101]

[0102] It can be seen from the table that there was no statistically significant difference between the two groups in each index before and after treatment (P>0.05).

[0103] There were significant differences in WBC, CRP, PCT, and IL-6 in the experimental group before and after treatment (P < 0.05), and the indicators of the control group also decreased to a certain extent before and after treatment. Except for the difference in CRP before and after treatment, the other indicators were not statistically significant (P > 0.05). This shows that the experimental drug can effectively control the inflammatory response and reduce the level of inflammatory factors.

[0104] 2.3 Analysis of wound healing related indicators before and after treatment

[0105] Intergroup analysis of wound granulation coverage showed no significant difference in wound granulation coverage at baseline (P>0.05), but there was significant difference at the end of the second week (P<0.05). Compared with the baseline, the wound granulation coverage increased in both groups after treatment.

[0106] Table 4 Analysis of the therapeutic effect of the difference in wound granulation coverage

[0107]

[0108] At the end of the second week of intervention, the wound healing rate was significantly different among the two groups (P<0.05), and the wound healing rate of the experimental group was better than that of the control group.

[0109] Table 5 Analysis of wound healing rate

[0110]

[0111] 2.4 Safety Index Analysis

[0112] After the safety indicators such as liver and kidney function were judged, it was found that there were no treatment-related abnormalities, and both groups were safe.

[0113] Table 6 Liver and kidney function values

[0114]

[0115]

[0116] The above test results show that the pharmaceutical composition can effectively improve diabetic foot ulcers caused by drug-resistant bacteria and has good safety.

[0117] 1 Clinical Case Examples

[0118] Liang, male, 70 years old, married, was admitted to the hospital with "right foot ulcer, pain and blackening for more than 4 months, aggravated for 1 week".

[0119] Four months ago, the patient accidentally caused local skin ulceration at the fourth toe of the right foot. Later, the fourth toe of the right foot gradually became black and gangrenous, and the wound secretion increased. He went to another hospital for treatment, but there was no obvious improvement. Later, the patient was hospitalized in our hospital for further diagnosis and treatment. Past history: history of type 2 diabetes for more than 25 years, usually oral "metformin hydrochloride tablets 0.5gTID, acarbose tablets, 50mg TID" subcutaneous injection "aspart insulin 30 injection, each time 22iu, before breakfast and dinner", recent monitoring of fasting blood sugar 18.3mmol / L, postprandial blood sugar about 23.7mmo1 / L. History of hypertension for more than 4 years, the highest up to 180 / 80mmHg, usually oral "metoprolol sustained-release tablets 47.5mgQD", usually poor blood pressure control. Coronary heart disease, angina pectoris for several years, no systematic diagnosis and treatment. Died in another hospital 4 years ago due to cerebral infarction treatment, leaving a message of adverse sequelae. Denied chronic disease history such as kidney disease, drug and food allergy history, family history of diabetes and hypertension.

[0120] Complete relevant examinations upon admission: routine blood tests, C-reactive protein, three infection items, electrolytes, renal function, liver function, plasma D-dimer, etc.

[0121] Table 7 Changes of clinical indicators before and after treatment

[0122]

[0123]

[0124] Diagnosis of TCM: Gangrene residual evil lingering syndrome

[0125] Western medicine diagnosis: 1. Type 2 diabetic foot gangrene 2. Lower extremity arteriosclerosis obliterans 3. Metatarsal osteomyelitis 4. Foot abscess 5. Type 2 diabetic peripheral vascular disease 6. Type 2 diabetic peripheral neuropathy 7. Coronary artery atherosclerotic heart disease 8. Angina pectoris 9. Old cerebral infarction 10. Hypertension grade 3 (extremely high risk)

[0126] The following are the specific treatment process drawings and instructions:

[0127] Figure 1 : The patient's family took photos at home and found that the entire foot was red and swollen, and the affected foot was extremely painful.

[0128] Figure 2 : Emergency surgery was performed after admission, and "skin and subcutaneous necrotic tissue excision" was performed under nerve block anesthesia. The culture results of wound secretions showed: Pseudomonas aeruginosa (multi-drug resistant). After the operation, the drug composition was used to clean the wound surface and peri-wound stains.

[0129] Figure 3 : After the operation, the pharmaceutical composition of the present invention was applied, the liquid hoop encircled the poison and reduced the swelling, gave the evil a way out, and the scope of wound infection was gradually controlled. The external application of the drug continued. The results of the wound secretion culture were reviewed: no bacterial growth.

[0130] Figure 4 : "Chronic ulcer repair + amputation of the 1st to 5th toes" was performed under nerve block anesthesia to repair the wound surface. After the operation, the drug composition was continued to be used to review the wound secretion culture results: no bacterial growth.

[0131] Figure 5 : Intermittent closed negative pressure suction is used, combined with a drug composition to flush and exchange secretions from the ulcer surface, provide a way out for the evil, and promote epithelial growth.

[0132] The results of wound secretion culture were reviewed: no bacterial growth. Multiple re-examinations confirmed that the drug-resistant bacteria had been eliminated.

[0133] Figure 6 : The wound healed and the patient was followed up, and the affected foot did not ulcerate again.

[0134] The above-mentioned embodiments and application examples are only descriptions of the preferred implementations of the present invention, and are not intended to limit the scope of the present invention. Without departing from the design spirit of the present invention, various improvements made to the technical solutions of the present invention by ordinary technicians in this field should fall within the protection scope determined by the claims of the present invention.

Claims

1. A Chinese medicine composition for treating drug-resistant diabetic foot ulcers, characterized in that: By weight, it includes the following functional components: 15-35 parts of white smilax china; 10-25 parts of salvia miltiorrhiza; 15-30 parts of scutellaria baicalensis; 4-26 parts of arisaema ciliata; 10-25 parts of Astragalus; 10-25 parts of Honeysuckle; 4-27 parts of Pittosporum tobira bark; 15-35 parts of Portulaca oleracea; 6-26 parts of Scutellaria baicalensis; 5-30 parts of Bletilla striata; 10-35 parts of Sanguisorba officinalis; 10-40 parts of Taraxacum officinale; 5-25 parts of Herba Polygoni Multiflori.

2. The Chinese medicine composition according to claim 1, comprising the following effective components by weight: 20-35 parts of white smilax china; 10-25 parts of salvia miltiorrhiza; 20-30 parts of scutellaria baicalensis; 6-20 parts of arisaema; 10-25 parts of Astragalus; 15-20 parts of Honeysuckle; 6-20 parts of Pittosporum tobira bark; 15-25 parts of Portulaca oleracea; 15-25 parts of Scutellaria baicalensis; 10-18 parts of Bletilla striata; 15-25 parts of Sanguisorba officinalis; 25-35 parts of Taraxacum officinale; 6-20 parts of Herba Polygoni Multiflori.

3. The Chinese medicine composition according to any one of the preceding claims, prepared from the following raw materials in parts by weight: 20 parts of Radix Bletillae; 25 parts of Radix Salviae Miltiorrhizae; 20 parts of Cortex Psoraleae; 20 parts of Arisaema Cum Bile; 25 parts of Astragalus; 20 parts of Honeysuckle; 6 parts of Pittosporum tobira bark; 20 parts of Portulaca oleracea; 15 parts of Scutellariae Radix; 13 parts of Bletilla striata; 25 parts of Sanguisorba officinalis; 25 parts of Taraxacum officinale; 6 parts of Herba Polygoni Multiflori.

4. The Chinese medicine composition according to any one of the preceding claims, prepared from the following raw materials in parts by weight: 35 parts of Radix Bletillae; 10 parts of Radix Salviae Miltiorrhizae; 30 parts of Radix Aconiti Lateralis Preparata; 6 parts of Rhizoma Arisaematis; 15 parts of Astragalus; 15 parts of Honeysuckle; 10 parts of Pittosporum tobira bark; Purslane 15 parts; 25 parts of Scutellariae Radix; 18 parts of Bletilla striata; 15 parts of Sanguisorba officinalis; 35 parts of Taraxacum officinale; 11 parts of Herba Polygoni Multiflori.

5. The Chinese medicine composition according to any one of the preceding claims, prepared from the following raw materials in parts by weight: 20 parts of Radix Bletillae; 20 parts of Radix Salviae Miltiorrhizae; 20 parts of Radix Aconiti Lateralis Preparata; 10 parts of Rhizoma Arisaematis; 20 parts of Astragalus; 10 parts of Honeysuckle; 23 parts of Pittosporum tobira; Purslane 25 parts; 15 parts of Scutellariae Radix; 7 parts of Bletilla striata; 20 parts of Sanguisorba officinalis; 25 parts of Taraxacum officinale; 25 parts of Herba Polygoni Multiflori.

6. The Chinese medicine composition according to any one of the preceding claims, characterized in that: The dosage form of the Chinese medicine composition is tincture.

7. A method for preparing a Chinese medicine composition according to any one of claims 1 to 6, comprising the following steps: After the above-mentioned Chinese medicinal raw materials are properly dried, they are made into coarse powder by dry mixing and crushing method, and soaked in medicinal ethanol for 1-3 weeks, stirred 3-6 times a day, each time for 5-10 minutes, filtered and the filtrate is taken, fully dissolved with water, and then quantified by 75% ethanol aqueous solution, and the alcohol content is 45-55%.

8. The preparation method according to claim 7, characterized in that: The mass ratio of the Chinese medicinal raw material to the medicinal ethanol is (1.5-2):

4.

9. Use of the Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a medicament for treating diabetic foot ulcers.

10. The use according to claim 9, characterized in that The purpose is to prepare medicine for treating diabetic foot ulcers caused by drug-resistant bacteria.

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