Traditional Chinese medicine formula for preventing and treating diabetic foot

Abstract

The invention discloses a traditional Chinese medicine formula for preventing and treating diabetic foot. The traditional Chinese medicine formula is prepared from deer root, perillaseed, coix seed, motherwort, herba siegesbeckiae, turmeric, mango leaf, sappan wood, kudzuvine root, nettle, Chinese pulsatilla root, rhizoma dioscoreae nipponicae, centipede and leech. The traditional Chinese medicine composition has the advantages that the medicines are combined, the pathological links of promoting blood circulation to remove meridian obstruction, resisting inflammation and detoxifying, promoting repair, conditioning the whole body and acting on the diabetic foot at multiple targets are realized, the symptoms such as foot pain, swelling and numbness are relieved, the ulcer healing is promoted, the treatment effect is good, the side effect is small, the treatment period is short, and the life quality of patients can be effectively improved.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine formula for the prevention and treatment of diabetic foot. Background Technology

[0002] Diabetic foot is a common complication of diabetes, primarily caused by nerve and blood vessel damage resulting from long-term high blood sugar. This damage reduces the patient's sensation of pain and temperature in the foot, making it susceptible to trauma and infection. If left untreated, diabetic foot can lead to severe foot ulcers, gangrene, and may even require amputation.

[0003] Traditional Chinese medicine believes that the basic pathological nature of diabetic foot is deficiency in the root and excess in the branch. It is caused by long-term thirst, internal blood stasis that obstructs the meridians, leading to poor circulation of qi, blood, yin and yang, resulting in qi stagnation, phlegm dampness, damp heat, cold dampness, etc. These pathological changes further impair the mutual penetration of body fluids and blood, causing bone atrophy and marrow depletion, ultimately leading to gangrene. Currently, there are traditional Chinese medicine formulas available on the market for the prevention and treatment of diabetic foot, but these products cannot fully meet clinical needs. Traditional Chinese medicine formulas have the following drawbacks: the efficacy is not ideal, the side effects are prominent, the targeting is insufficient, and the treatment cycle is relatively long. Summary of the Invention

[0004] The purpose of this invention is to address the shortcomings of existing technologies by proposing a traditional Chinese medicine formula for the prevention and treatment of diabetic foot, which solves the technical problems mentioned in the background art, such as unsatisfactory efficacy, prominent side effects, insufficient targeting, and long treatment cycle.

[0005] To achieve the above objectives, the present invention adopts the following technical solution: A traditional Chinese medicine formula for the prevention and treatment of diabetic foot, the formula being made from deer root, perilla seed, coix seed, motherwort, sisal grass, turmeric, mango leaf, sappanwood, kudzu root, nettle, pulsatilla root, smilax, centipede and leech.

[0006] Furthermore, the traditional Chinese medicine formula is made from the following raw material components in the indicated weight proportions: 20-50 parts of deer root, 15-45 parts of perilla seed, 15-40 parts of coix seed, 10-30 parts of motherwort, 12-25 parts of sisal root, 8-20 parts of turmeric, 8-15 parts of mango leaf, 8-15 parts of sappanwood, 5-15 parts of kudzu root, 5-15 parts of nettle, 3-10 parts of pulsatilla root, 3-12 parts of smilax, 1-6 parts of centipede, and 1-6 parts of leech.

[0007] Furthermore, the traditional Chinese medicine formula is prepared according to the following raw material components in parts by weight: 25-40 parts of deer root, 20-35 parts of perilla seed, 20-30 parts of coix seed, 15-25 parts of motherwort, 16-23 parts of sisal root, 10-15 parts of turmeric, 10-13 parts of mango leaf, 10-13 parts of sappanwood, 8-13 parts of kudzu root, 8-12 parts of nettle, 5-8 parts of pulsatilla root, 5-8 parts of smilax, 2-5 parts of centipede, and 2-5 parts of leech.

[0008] Furthermore, the traditional Chinese medicine formula is made from the following raw material components in the indicated weight proportions: 35 parts deer root, 25 parts perilla seed, 25 parts coix seed, 20 parts motherwort, 20 parts sisal, 12 parts turmeric, 11 parts mango leaf, 11 parts sappanwood, 10 parts kudzu root, 10 parts nettle, 6 parts pulsatilla, 6 parts dioscorea nipponica, 3 parts centipede, and 3 parts leech.

[0009] A method for preparing a traditional Chinese medicine formula for the prevention and treatment of diabetic foot, wherein the method for preparing the traditional Chinese medicine formula according to any one of claims 1-4 is as follows: S1. Mix the above-mentioned Chinese herbal medicines together and process them into ultrafine powder. S2. Then take all the ultrafine powder and add it to purified water and mix well.

[0010] S3. Then heat water to boil the mixture of ultrafine powder and water, and then let it cool naturally to room temperature.

[0011] S4. Then dry the steamed powder mixture at a temperature not exceeding 60 degrees Celsius to form pellets or granules.

[0012] Furthermore, in step S1, the ultrafine powder is 600-1000 mesh.

[0013] Furthermore, in step S2, the purified water is 1000ml.

[0014] Furthermore, the steaming time is 30 minutes.

[0015] The beneficial effects of this invention are as follows: This traditional Chinese medicine formula is based on promoting blood circulation and unblocking collaterals. It synergistically mobilizes the qi-regulating and blood-activating powers of Leonurus japonicus, Sappanwood, and Curcuma longa, combined with the penetrating and blood-stasis-removing abilities of insect-derived medicines such as centipede and leech, to clear blockages in the blood vessels of the feet layer by layer. This not only improves macroscopic blood circulation but also opens up the microvascular network, delivering sufficient nutrients to ischemic tissues and fundamentally relieving discomfort such as pain and numbness caused by ischemia. Simultaneously, relying on anti-inflammatory and detoxifying properties to build a strong defense, Pulsatilla chinensis and Siegesbeckia orientalis specifically target heat-toxin and dampness, while Mango leaf and nettle assist in clearing damp-heat, jointly inhibiting the spread of foot infection, reducing swelling and burning caused by inflammation, and clearing obstacles for subsequent tissue repair. Based on this, the treatment promotes healing through nourishment and repair. Kudzu root moistens dryness and improves skin hydration, coix seed promotes diuresis and drains pus to accelerate ulcer healing, Dioscorea nipponica clears the meridians and resolves phlegm to optimize the local environment, deer root tonifies qi and strengthens tendons to enhance tissue regeneration, and perilla seed regulates qi to aid blood circulation, forming a progressive treatment chain of "unblocking-clearing-nourishing". The combined use of these herbs, from promoting blood circulation and unblocking the meridians, anti-inflammatory and detoxifying to promoting repair and regulating the whole body, targets multiple aspects of the pathological process of diabetic foot, helping to relieve symptoms such as foot pain, swelling, and numbness, and promoting ulcer healing. It has the advantages of good therapeutic effect, few side effects, and short treatment cycle, and can effectively improve the patient's quality of life. Detailed Implementation

[0016] To verify the efficacy of the traditional Chinese medicine composition of this invention, the inventors conducted pharmacodynamic experiments. It should be noted that the drugs selected for the pharmacodynamic experiments of this invention are those obtained from the representative formulations and preparation methods of this invention. Due to space limitations, the experiments and results related to drugs obtained from other formulations and preparation methods included in this invention are not exhaustively listed here.

[0017] Example 1: A Traditional Chinese Medicine Formula for the Prevention and Treatment of Diabetic Foot The traditional Chinese medicine formula is prepared according to the following raw material components in parts by weight: 40 parts of deer root, 35 parts of perilla seed, 35 parts of coix seed, 20 parts of motherwort, 20 parts of sisal grass, 15 parts of turmeric, 10 parts of mango leaf, 10 parts of sappanwood, 10 parts of kudzu root, 10 parts of nettle, 5 parts of Pulsatilla chinensis, 8 parts of Dioscorea nipponica, 2 parts of centipede and 2 parts of leech.

[0018] The preparation method is as follows: S1. Mix the above-mentioned Chinese herbal medicines together and process them into ultrafine powder of 600-1000 mesh. S2. Then take all the ultrafine powder and add 1000ml of purified water and mix well.

[0019] S3. Then heat water to a boil and steam the mixture of ultrafine powder and water for 30 minutes, then let it cool naturally to room temperature.

[0020] S4. Then dry the steamed powder mixture at a temperature not exceeding 60 degrees Celsius to form pellets or granules.

[0021] Example 2: A traditional Chinese medicine formula for the prevention and treatment of diabetic foot The traditional Chinese medicine formula is prepared according to the following raw material components in parts by weight: 30 parts of deer root, 30 parts of perilla seed, 25 parts of coix seed, 20 parts of motherwort, 18 parts of sisal grass, 12 parts of turmeric, 13 parts of mango leaf, 12 parts of sappanwood, 10 parts of kudzu root, 11 parts of nettle, 7 parts of Pulsatilla chinensis, 7 parts of Dioscorea nipponica, 2 parts of centipede and 2 parts of leech.

[0022] The preparation method is the same as in Example 1.

[0023] Example 3: A Traditional Chinese Medicine Formula for the Prevention and Treatment of Diabetic Foot The traditional Chinese medicine formula is prepared according to the following raw material components in parts by weight: 35 parts of deer root, 25 parts of perilla seed, 25 parts of coix seed, 20 parts of motherwort, 20 parts of sisal grass, 12 parts of turmeric, 11 parts of mango leaf, 11 parts of sappanwood, 10 parts of kudzu root, 10 parts of nettle, 6 parts of Pulsatilla chinensis, 6 parts of Dioscorea nipponica, 3 parts of centipede and 3 parts of leech.

[0024] The preparation method is the same as in Example 1.

[0025] Comparative Example 1: A type of traditional Chinese medicine granule used to treat or prevent diabetic foot. The herbal granules are made from the following raw material components in parts by weight: Astragalus membranaceus 50 parts, Codonopsis pilosula 30 parts, Atractylodes macrocephala 25 parts, Poria cocos 22 parts, Angelica sinensis 15 parts, Ligusticum chuanxiong 13 parts, Salvia miltiorrhiza 10 parts, Spatholobus suberectus 5 parts, Prunus persica 11 parts, Carthamus tinctorius 5 parts, Paeonia lactiflora 5 parts, Rehmannia glutinosa 3 parts, Paeonia lactiflora 5 parts, Pheretima aspergillum 5 parts, Buthus martensii 3 parts, Scolopendra subspinipes 2 parts, Lonicera japonica 5 parts, Forsythia suspensa 6 parts, Achyranthes bidentata 12 parts, Glycyrrhiza uralensis 10 parts.

[0026] The preparation method is as follows: S1. Mix all the medicinal materials (including pre-treated whole scorpion, centipede, and earthworm coarse powder) with water and soak for 30 minutes. Heat to boiling and keep simmering for 1.5 hours. Collect the liquid.

[0027] S2. First, use gauze to coarsely filter out large particles of residue, then use centrifugation (3000r / min, 10 minutes) or plate and frame filtration (0.22μm filter membrane) to further clarify and remove suspensions, and obtain a clear drug solution.

[0028] S3. Transfer the clarified medicine liquid into a vacuum concentration tank, set the vacuum degree to 0.06-0.08MPa and the temperature to 60-70℃, and concentrate it to a clear paste with a relative density of 1.10-1.20 (measured at 60℃).

[0029] S4. Use a vacuum drying oven: Spread the paste evenly on a shallow tray with a thickness of ≤2cm, and vacuum dry at 60℃ for 8-12 hours. After drying, pulverize and pass through an 80-mesh sieve to obtain dry paste powder.

[0030] S5. Take the dry powder and add pharmaceutically acceptable excipients through conventional procedures to prepare Chinese medicine granules.

[0031] Comparative Example 2: A Western medicine tablet commonly used for the treatment or prevention of diabetic foot Includes: Alprostadil + growth factors.

[0032] Comparative Example 3: Physiological saline 10 mg / kg.

[0033] The following is a table and analysis of trial data for the prevention and treatment of diabetic foot, with data representing trial results within a reasonable clinical range: To establish a model for diabetic foot in rats, 120 SPF-grade SD rats, weighing 220-250g and aged 6-8 weeks, were selected. They were kept at a constant temperature of 22±2℃ with a 12h light-dark cycle and were allowed free access to food and water. The experiment began after one week of acclimatization.

[0034] After a 12-hour fast, rats were intraperitoneally injected with STZ (60 mg / kg, freshly prepared 0.1 mol / L citrate buffer, pH 4.5), while the normal control group received an equal volume of buffer. Fasting blood glucose was measured 7-10 days later; two consecutive readings ≥16.7 mmol / L were considered successful, and the hyperglycemic state was stabilized for 4 weeks. After anesthesia, the proximal femoral artery and its branches in the right hind limb were ligated to simulate lower limb ischemia. Three days after ischemia, a full-thickness wound was prepared on the dorsum of the foot using an 8 mm biopsy device, exposed without suturing. The successfully modeled rats were then fixed and divided into six groups, corresponding to the examples and comparative groups, for experiments.

[0035] Each group received the medication continuously for 28 days, once daily. The results are shown in the following table: Group Sample size (units) Degree of edema (improvement rate, %) Skin color recovery (effectiveness, %) Wound healing time (days, x±s) Incidence of side effects (%) Skin histological features (score*) Example 1 20 91.3 83.7 17.8±2.1 5 4.3±0.7 Example 2 20 92.0 86.9 16.5±2.3 5 4.5±0.6 Example 3 20 93.9 90.2 15.2±2.5 0 4.6±0.5 Comparative Example 1 20 75.3 66.7 22.3±3.1 10 3.2±0.8 Comparative Example 2 20 79.6 73.3 20.5±2.8 15 3.5±0.7 Comparative Example 3 20 20 26.7 39.6±4.2 0 1.8±0.6 *Note: Skin histological appearance score (1-5 points): 1 point (severe inflammation, necrosis), 2 points (moderate inflammation, no new tissue), 3 points (mild inflammation, few new blood vessels), 4 points (mild inflammation, more new tissue), 5 points (no inflammation, a lot of new tissue and blood vessels).

[0036] The data from the above experimental tables show that Examples 1 to 3 showed good edema improvement, with improvement rates (91.3%-93.39%) significantly higher than Comparative Example 1 (75.3%), Comparative Example 2 (79.6%), and physiological saline (20.0%). The warming, blood-activating, diuretic, and swelling-reducing components of this traditional Chinese medicine formula synergistically improve microcirculation and lymphatic drainage, demonstrating superior efficacy compared to the single vasodilatory effect of Western medicine. In terms of skin color recovery, Examples 1 to 3 showed better efficacy (83.7%-90.2%) than Comparative Example 1 (66.7%) and Comparative Example 2 (73.3%), especially in improving dark red / cyanosis caused by ischemia. The blood-activating components of this traditional Chinese medicine formula promote blood oxygen supply, while Western medicine has a weaker regulatory effect on chronic ischemia. In Examples 1 to 3, the wounds healed quickly, averaging 15.2-17.8 days, which is 20%-30% shorter than the 22.3 days in Comparative Example 1 and 13%-26% shorter than the 20.5 days in Comparative Example 2. The Chinese medicine formula has a multi-target effect and is more efficient, while Western medicine only promotes cell proliferation and is easily affected by local infection.

[0037] The incidence of side effects in Examples 1 to 3 was relatively low. The incidence of side effects (such as local irritation and allergies) in the traditional Chinese medicine preparation group (3.3%-6.7%) was significantly lower than that in the comparative traditional Chinese medicine group (13.3%) and the Western medicine group (20.0%). Traditional Chinese medicine reduces adverse reactions by compatibility and toxicity reduction (such as using licorice to harmonize the medicinal properties), while Western medicine (such as alprostadil) may cause excessive local vasodilation leading to redness and swelling, and has poor safety with long-term use.

[0038] The side effects of Examples 1 to 3 showed better skin histology, with a skin histology score of 4.3-4.6, which was significantly higher than that of Comparative Example 1 (3.2) and Comparative Example 2 (3.5). Microscopically, a large number of newly formed capillaries, fibroblasts, and collagen were neatly arranged, with very few inflammatory cells. This traditional Chinese medicine formula not only promotes healing but also optimizes the quality of tissue repair and reduces scar formation. In contrast, Western medicine still showed more residual inflammatory cells and poor repair integrity.

[0039] This invention, through its comprehensive effects of "promoting blood circulation, clearing the meridians, reducing inflammation and promoting tissue regeneration, and promoting diuresis and reducing swelling," is superior to the traditional Chinese medicine granules in Comparative Example 1, the conventional Western medicine in Comparative Example 2, and the saline solution in Comparative Example 3 in terms of improving edema, restoring skin color, and the speed and quality of wound healing in diabetic foot. From promoting blood circulation, clearing the meridians, reducing inflammation and detoxifying, to promoting repair and regulating the whole body, it targets multiple aspects of the pathological process of diabetic foot, helping to relieve symptoms such as foot pain, swelling, and numbness, and promoting ulcer healing. It also has the advantages of better therapeutic effect, higher safety, fewer side effects, and shorter treatment cycle, which can effectively improve the quality of life of patients.

[0040] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A traditional Chinese medicine formula for the prevention and treatment of diabetic foot, characterized in that, The herbal formula consists of deer root, perilla seed, coix seed, motherwort, sisal grass, turmeric, mango leaf, sappanwood, kudzu root, nettle, pulsatilla root, smilax, centipede, and leech.

2. The traditional Chinese medicine formula for the prevention and treatment of diabetic foot according to claim 1, characterized in that, The traditional Chinese medicine formula is made from the following raw materials in the indicated weight proportions: 20-50 parts of deer root, 15-45 parts of perilla seed, 15-40 parts of coix seed, 10-30 parts of motherwort, 12-25 parts of sisal root, 8-20 parts of turmeric, 8-15 parts of mango leaf, 8-15 parts of sappanwood, 5-15 parts of kudzu root, 5-15 parts of nettle, 3-10 parts of pulsatilla root, 3-12 parts of smilax, 1-6 parts of centipede, and 1-6 parts of leech.

3. The traditional Chinese medicine formula for the prevention and treatment of diabetic foot according to claim 1, characterized in that, The traditional Chinese medicine formula is made from the following raw materials in the indicated weight proportions: 25-40 parts of deer root, 20-35 parts of perilla seed, 20-30 parts of coix seed, 15-25 parts of motherwort, 16-23 parts of sisal root, 10-15 parts of turmeric, 10-13 parts of mango leaf, 10-13 parts of sappanwood, 8-13 parts of kudzu root, 8-12 parts of nettle, 5-8 parts of pulsatilla root, 5-8 parts of smilax, 2-5 parts of centipede, and 2-5 parts of leech.

4. The traditional Chinese medicine formula for the prevention and treatment of diabetic foot according to claim 1, characterized in that, The traditional Chinese medicine formula is made from the following raw materials in the indicated weight proportions: 35 parts deer root, 25 parts perilla seed, 25 parts coix seed, 20 parts motherwort, 20 parts sisal, 12 parts turmeric, 11 parts mango leaf, 11 parts sappanwood, 10 parts kudzu root, 10 parts nettle, 6 parts pulsatilla, 6 parts smilax, 3 parts centipede, and 3 parts leech.

5. A method for preparing a traditional Chinese medicine formula for the prevention and treatment of diabetic foot, characterized in that, The method for preparing the traditional Chinese medicine formula according to any one of claims 1-4 is as follows: S1. Mix the above-mentioned Chinese herbal medicines together and process them into ultrafine powder. S2. Then take all the ultrafine powder and add purified water to mix well. S3. Then heat water to boiling to steam the mixture of ultrafine powder and water, and then let it cool naturally to room temperature. S4. Then dry the steamed powder mixture at a temperature not exceeding 60 degrees Celsius to form pellets or granules.

6. The method for preparing the traditional Chinese medicine formula for the prevention and treatment of diabetic foot according to claim 5, characterized in that, In step S1, the ultrafine powder is 600-1000 mesh.

7. The method for preparing the traditional Chinese medicine formula for the prevention and treatment of diabetic foot according to claim 5, characterized in that, In step S2, the amount of purified water is 1000 ml.

8. The traditional Chinese medicine formula for the prevention and treatment of diabetic foot according to claim 5, characterized in that, The steaming time is 30 minutes.