Traditional Chinese medicine composition for treating diabetic foot and application

Abstract

The invention discloses a traditional Chinese medicine composition for treating diabetic foot. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 9-30 parts of compound of glauber-salt and liquorice, 9-15 parts of talc, 9-15 parts of calamine, 9-15 parts of radix sophorae flavescentis, 9-20 parts of raw rhubarb, 3-12 parts of moutan bark, 3-12 parts of cortex dictamni, 9-15 parts of fructus cnidii, 9-15 parts of fructus kochiae, 9-20 parts of gypsum and 9-15 parts of mint. The traditional Chinese medicine composition for external use has the effects of clearing away heat and toxic materials, relieving swelling and pain, astringing dampness and astringing sores and the like, can obviously relieve symptoms such as red, swollen and hot pain of diabetic feet, is remarkable in effect, economical, convenient and small in side effect, and has the advantages of being definite in curative effect, free of toxic and side effects, low in cost and convenient to popularize and apply.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicines, and in particular, relates to a traditional Chinese medicine composition for treating diabetic foot and application thereof. Background Art

[0002] Diabetes is a common chronic disease. One of the common complications of diabetic patients is diabetic foot. About 15% of diabetic patients will develop foot ulcers in their lifetime. Diabetic foot not only seriously affects the patient's quality of life, but may also lead to amputation and even endanger life. The cumulative recurrence rate of diabetic foot in the first year after healing is 18.4% (35 / 190), the cumulative recurrence rate in the second year is 33.2% (63 / 190), and the cumulative recurrence rate in the third year is 45.3% (86 / 190). 70% of diabetic foot patients die within 5 years after amputation surgery. 5% of diabetic patients die within 12 months after visiting the doctor for the first ulcer, and 42.2% of patients die within 5 years.

[0003] The International Diabetic Foot Working Group defines diabetic foot as lower limb infection, ulceration and / or deep tissue damage caused by diabetic patients due to combined neuropathy and various degrees of lower limb vascular disease. Diabetic foot is roughly divided into three types: neuropathic, ischemic and mixed.

[0004] Diabetic foot belongs to the category of "gangrene" and "diabetes gangrene" in traditional Chinese medicine. If it occurs on top of diabetes, the person's foot ends are numb, painful, cold or dry and black, or the tendons and bones are ulcerated, which is called gangrene. It has the characteristics of "root deficiency and superficial excess, rapid infiltration of poison, difficulty in removing rotten flesh, and difficulty in growing new flesh".

[0005] At present, there is an urgent need for an external Chinese medicine composition for treating diabetic foot that has cheap raw materials, is easy to prepare and easy to use. Summary of the invention

[0006] The purpose of the invention is to provide a traditional Chinese medicine composition for treating diabetic foot.

[0007] Another object of the present invention is to provide an application of the traditional Chinese medicine composition in the preparation of a medicine for treating diabetic foot.

[0008] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0009] The first aspect of the present invention provides a traditional Chinese medicine composition for treating diabetic foot, which is prepared from the following components in parts by weight: 9-30 parts of Xuanming powder, 9-15 parts of talc, 9-15 parts of calamine, 9-15 parts of sophora flavescens, 9-20 parts of raw rhubarb, 3-12 parts of peony bark, 3-12 parts of white peony root, 9-15 parts of cnidium monnieri, 9-15 parts of kochia scoparia, 9-20 parts of gypsum, and 9-15 parts of mint.

[0010] Preferably, the traditional Chinese medicine composition for treating diabetic foot is made of the following components in parts by weight: 9 parts of Xuanming powder, 9 parts of talc, 9 parts of calamine, 9 parts of sophora flavescens, 9 parts of raw rhubarb, 3 parts of peony bark, 3 parts of Dictamni cortex, 9 parts of Cnidium monnieri, 9 parts of Kochia scoparia, 9 parts of gypsum, and 9 parts of mint.

[0011] Preferably, the Chinese medicine composition for treating diabetic foot is made of the following components in parts by weight: 30 parts of Xuanming powder, 15 parts of talc, 15 parts of calamine, 15 parts of sophora flavescens, 20 parts of raw rhubarb, 12 parts of peony bark, 12 parts of Dictamni cortex, 15 parts of Cnidium monnieri, 15 parts of Kochia scoparia, 20 parts of gypsum, and 15 parts of mint.

[0012] Preferably, the Chinese medicine composition for treating diabetic foot is made of the following components in parts by weight: 21 parts of Xuanming powder, 12 parts of talc, 12 parts of calamine, 12 parts of sophora flavescens, 15 parts of raw rhubarb, 9 parts of peony bark, 9 parts of Dictamni cortex, 12 parts of Cnidium monnieri, 12 parts of Kochia scoparia, 15 parts of gypsum, and 12 parts of mint.

[0013] The second aspect of the present invention provides a use of the traditional Chinese medicine composition in the preparation of a medicine for treating diabetic foot.

[0014] The invention uses Xuanming powder as the main drug, raw rhubarb and talc as the assistant drugs, calamine, gypsum, cnidium monnieri and kochia scoparia as the adjuvant drugs, and sophora flavescens, peony bark, white peony root and mint as the guiding drugs.

[0015] The properties, flavors, meridians and functions of the Chinese medicine raw materials of the present invention are as follows:

[0016] Xuanming powder: [Nature and flavor] Salty, bitter, cold. Enters the stomach and large intestine meridians. [Effects] Laxative, softening hard masses, clearing away heat.

[0017] Talc: [Nature and flavor] Sweet, light, cold. Enters the stomach and bladder meridians. [Effects] Promotes diuresis and relieves stranguria, clears away summer heat.

[0018] Calamine: [Nature and flavor and meridians] Sweet, neutral. Enters the liver and stomach meridians. [Effects] Improves eyesight, removes cataracts, absorbs dampness and promotes skin regeneration.

[0019] Sophora flavescens: [Nature and flavor] Bitter, cold. Entries to the heart, liver, stomach, large intestine, bladder meridians. [Effects] Clears away heat and dampness, dispels wind and kills insects, and is a diuretic.

[0020] Raw rhubarb: [Nature and flavor] Bitter, cold. Enters the spleen, stomach, large intestine, liver, heart meridians. [Effects] Purgative, clearing away heat and purging fire, detoxifying, promoting blood circulation and removing blood stasis.

[0021] Peony bark: [Nature and flavor] Bitter, pungent, slightly cold. Entries to the heart, liver, and kidney meridians. [Effects] Clears heat and cools blood, promotes blood circulation and dissipates blood stasis.

[0022] Dictamni: [Nature and flavor] Bitter, cold. Enters the spleen and stomach meridians. [Effects] Clears away heat and detoxifies, removes dampness, and relieves itching.

[0023] Cnidium monnieri: [Nature and flavor] Pungent, bitter, warm. Enters the kidney meridian. [Effects] Warms the kidney and strengthens yang, dispels cold and wind, dries dampness and kills insects.

[0024] Kochia scoparia: [Nature and flavor and meridians] Bitter, cold. Enters the bladder meridian. [Effects] Clears heat and promotes diuresis, relieves itching.

[0025] Gypsum: [Nature and flavor] Spicy, sweet, very cold. Enters the lung and stomach meridians. [Effects] Clears away heat and purges fire, relieves restlessness and quenches thirst.

[0026] Peppermint: [Nature and flavor and meridians] Spicy, cool. Enters the liver and lung meridians. [Effects] Disperses wind-heat, clears the head and eyes, relieves sore throat, and clears rashes.

[0027] The third aspect of the present invention provides a pharmaceutical preparation made from the traditional Chinese medicine composition.

[0028] The dosage form of the pharmaceutical preparation is selected from pastes, ointments, creams, gels, paints, plasters, and plasters.

[0029] Due to the adoption of the above technical solution, the present invention has the following advantages and beneficial effects:

[0030] The traditional Chinese medicine composition of the present invention has the effects of clearing away heat and detoxifying, relieving swelling and relieving pain, absorbing moisture and healing ulcers when applied externally, can obviously relieve symptoms such as redness, swelling, heat and pain of diabetic foot, has remarkable effect, is economical and convenient, has little side effect, has definite efficacy, is non-toxic and side effect, is low in cost, and is easy to promote and apply. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 It is a schematic diagram of wound healing results.

[0032] Figure 2 It is a schematic diagram of the HE staining results of the skin wounds of mice in each group.

[0033] Figure 3 This is a schematic diagram of the results of qPCR detection of changes in the mRNA levels of IL-6, a signature inflammatory gene of the M1 macrophage type.

[0034] Figure 4 This is a schematic diagram of the results of qPCR detection of changes in the mRNA levels of TNF-α, a signature inflammatory gene of the M1 type of macrophages. DETAILED DESCRIPTION

[0035] In order to explain the present invention more clearly, the present invention is further described below in conjunction with preferred embodiments. It should be understood by those skilled in the art that the following specific description is illustrative rather than restrictive, and should not be used to limit the scope of protection of the present invention.

[0036] Example 1

[0037] A Chinese medicine composition for treating diabetic foot comprises:

[0038] Xuanming powder 9g, talc (powder) 9g, calamine (powder) 9g, sophora flavescens (powder) 9g, raw rhubarb (powder) 9g, peony bark (powder) 3g, white peony bark (powder) 3g, cnidium monnieri (powder) 9g, kochia scoparia (powder) 9g, gypsum (powder) 9g, mint (powder) 9g.

[0039] A method for preparing a Chinese medicine composition for treating diabetic foot comprises the following steps:

[0040] Add 9g of Xuanming powder to 180ml of water at 25℃, stir thoroughly and dissolve until there are no crystals. Add 9g of talc (powder), 9g of calamine (powder), 9g of sophora flavescens (powder), 9g of raw rhubarb (powder), 3g of peony bark (powder), 3g of Dictamni (powder), 9g of Cnidium monnieri (powder), 9g of Kochia scoparia (powder), 9g of gypsum (powder) and 9g of mint (powder) to the above solution, stir evenly until a viscous paste is obtained to obtain a Chinese medicine composition paste. Scrape 50g of the Chinese medicine composition paste, spread it evenly on gauze, cover it with another layer of gauze and set aside.

[0041] Example 2

[0042] A Chinese medicine composition for treating diabetic foot comprises:

[0043] Xuanming powder 30g, talc (powder) 15g, calamine (powder) 15g, sophora flavescens (powder) 15g, raw rhubarb (powder) 20g, peony bark (powder) 12g, white peony bark (powder) 12g, cnidium monnieri (powder) 15g, kochia scoparia (powder) 15g, gypsum (powder) 20g, mint (powder) 15g.

[0044] A method for preparing a Chinese medicine composition for treating diabetic foot comprises the following steps:

[0045] Add 30g of Xuanming powder to 300ml of water at 25℃, stir thoroughly and dissolve until there is no crystallization. Add 15g of talc (powder), 15g of calamine (powder), 15g of sophora flavescens (powder), 20g of raw rhubarb (powder), 12g of peony bark (powder), 12g of Dictamni cortex (powder), 15g of Cnidium monnieri (powder), 15g of Kochia scoparia (powder), 20g of gypsum (powder) and 15g of mint (powder) to the above solution, stir evenly until a viscous paste is obtained to obtain a Chinese medicine complex paste. Scrape 50g of the Chinese medicine complex paste, spread it evenly on gauze, cover it with another layer of gauze and set aside.

[0046] Example 3

[0047] A Chinese medicine composition for treating diabetic foot comprises:

[0048] Xuanming powder (powder) 21g, talc (powder) 12g, calamine (powder) 12g, sophora flavescens (powder) 12g, raw rhubarb (powder) 15g, peony bark (powder) 9g, white mulberry bark (powder) 9g, cnidium monnieri (powder) 12g, kochia scoparia (powder) 12g, gypsum (powder) 15g, mint (powder) 12g.

[0049] A method for preparing a Chinese medicine composition for treating diabetic foot comprises the following steps:

[0050] Add 21g of Xuanming powder to 240ml of water at 25°C, stir thoroughly and dissolve until there is no crystallization. Add 12g of talc (powder), 12g of calamine (powder), 12g of sophora flavescens (powder), 15g of raw rhubarb (powder), 9g of peony bark (powder), 9g of Dictamni (powder), 12g of Cnidium monnieri (powder), 12g of Kochia scoparia (powder), 15g of gypsum (powder), 12g of Polygonatum sibiricum (powder), and 12g of mint (powder) to the above solution, stir evenly until a viscous paste is obtained to obtain a Chinese medicine complex paste. Scrape 50g of the Chinese medicine complex paste, spread it evenly on gauze, cover it with another layer of gauze and set aside.

[0051] Example 4

[0052] Pharmacodynamics experiment of the Chinese medicine composition for treating diabetic foot of the present invention

[0053] (I) Case source: The cases were collected from 60 patients with diabetic foot who visited the ward of Shanghai Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine for diabetic foot between January 2023 and December 2023, with informed consent.

[0054] (II) Inclusion criteria: All patients met both the Western medicine diagnostic criteria and the TCM symptom diagnostic criteria. Reference was made to the "Chinese Expert Consensus on the Prevention and Treatment of Diabetic Foot with Integrated Traditional Chinese and Western Medicine (1st Edition)" formulated by the Peripheral Vascular Disease Professional Committee of the Chinese Society of Integrated Traditional Chinese and Western Medicine in 2019 and the "Expert Consensus on Wound Repair and Treatment of Diabetic Foot" formulated by the Diabetic Foot Study Group of the Peripheral Vascular Disease Professional Committee of the Chinese Society of Microcirculation in 2018.

[0055] 1. Western medicine diagnostic criteria (disease): Diabetic foot refers to lower limb infection, ulcer formation and / or deep tissue damage caused by diabetic patients due to combined neuropathy and various degrees of lower limb vascular lesions. Diabetic foot is roughly divided into three types: neuropathic, ischemic, and mixed.

[0056] 2. TCM diagnostic criteria (differentiation): damp-heat congestion type. Main symptoms: flushed face, thirst, swelling or pain in the affected limb, cyanosis of toes, red and swollen ulcer surface, more and sticky local purulent secretions, wet gangrene-like changes, fat and red tongue, greasy yellow tongue coating, slippery and rapid pulse.

[0057] (III) Exclusion criteria:

[0058] (1) Incomplete information;

[0059] (2) Those who are allergic to the test drug or have adverse reactions;

[0060] (3) Unable to cooperate with dressing changes or unable to maintain external application;

[0061] (4) Severe trauma or severe lower extremity vascular disease requiring interventional treatment;

[0062] (5) Severe liver and kidney damage, hypoproteinemia or other underlying diseases that are not well controlled by treatment;

[0063] (6) Pregnancy or lactation;

[0064] (7) Currently participating in clinical research of other drugs.

[0065] (IV) Research methods:

[0066] 1. Quantitative scoring of TCM syndromes of diabetic foot (refer to "Chinese Expert Consensus on the Prevention and Treatment of Diabetic Foot with Integrated Traditional Chinese and Western Medicine (1st Edition)", and "Guidelines for Clinical Research of New Chinese Medicines (First Series)").

[0067] The scoring criteria are shown in Table 1:

[0068] Table 1

[0069]

[0070] 2. Treatment Methods

[0071] The preparation method of the Chinese medicine composition paste comprises the following steps:

[0072] Add 9g of Xuanming powder to 180ml of water at 25℃, stir thoroughly and dissolve until there are no crystals. Add 9g of talc (powder), 9g of calamine (powder), 9g of sophora flavescens (powder), 9g of raw rhubarb (powder), 3g of peony bark (powder), 3g of Dictamni (powder), 9g of Cnidium monnieri (powder), 9g of Kochia scoparia (powder), 9g of gypsum (powder) and 9g of mint (powder) to the above solution, stir evenly until a viscous paste is obtained to obtain a Chinese medicine composition paste. Scrape 50g of the Chinese medicine composition paste, spread it evenly on gauze, cover it with another layer of gauze and set aside.

[0073] When using, first clean the local skin with normal saline, take an appropriate amount of the Chinese medicine composition paste according to the size of the lesion, and apply it to the lesion. If there is ulceration on the skin, cover it with sterile gauze to isolate and cover it. The thickness of the application is about 2mm, and the range should be 2cm beyond the lesion. Cover it with 4 layers of gauze, fix it properly with a bandage, and clean and change the dressing once a day.

[0074] Western medicine control group: first use 1-2 pieces of gauze of appropriate size, dip a small amount of 50% magnesium sulfate solution (magnesium sulfate, produced by Hebei Wuluo Pharmaceutical Co., Ltd., approval number: H13022977), wring it dry, let the gauze soak, and apply it to the swollen area.

[0075] (V) Efficacy observation:

[0076] 1. Clinical observation indicators: observe the changes of diabetic foot in patients before and after treatment, including comparison of symptom quantitative scores before and after treatment and comparison of clinical effectiveness after treatment. Clinical effectiveness = (cured + markedly effective) / total number of cases in each group × 100%.

[0077] 2. Laboratory test indicators: IL-6, PCT, CRP and TNF-α tests were performed once before and after treatment as required, and detailed records were made. Anterior venous blood was drawn, serum was separated, and the enzyme-linked immunosorbent double antibody sandwich method (ELISA) was used to determine the levels of IL-6, PCT, CRP and TNF-α in serum.

[0078] 3. Efficacy judgment standard: refer to the "Chinese Expert Consensus on the Prevention and Treatment of Diabetic Foot with Integrated Traditional Chinese and Western Medicine (1st Edition)", and use the nimodipine method, that is, the ratio of the difference in symptom scores before and after treatment to the score before treatment is used as the efficacy judgment value.

[0079] Recovery: clinical symptoms and signs disappear or almost disappear, and the syndrome score reduction rate is ≥ 90%;

[0080] Markedly effective: clinical symptoms and signs are significantly improved, 70% ≤ syndrome score reduction rate < 90%;

[0081] Effective: clinical symptoms and signs are improved, 30% ≤ syndrome score reduction rate < 70%;

[0082] Ineffective: There is no significant improvement in clinical symptoms and signs, or they may even worsen, and the reduction rate of symptom scores is less than 30%.

[0083] (VI) Experimental results

[0084] 1. Clinical observation

[0085] (1) The comparison results of symptom quantitative scores before and after treatment are shown in Table 2:

[0086] Table 2

[0087]

[0088]

[0089] (Comparison between the two groups before treatment: p<0.05△Comparison between the two groups after treatment: p<0.05●Comparison before and after treatment within the group: p<0.05■)

[0090] There was no significant difference in clinical symptoms and signs between the two groups of patients before treatment, including skin temperature, skin color, humidity, edema, pus volume, pus color, pus quality, and pus odor (P>0.05), and the differences were comparable.

[0091] After treatment, the scores of all symptoms and signs in the Chinese medicine external application group were lower than those before treatment, and the difference was significant and statistically significant (P < 0.05). The scores of all symptoms and signs in the control group were lower than those before treatment, and the difference was significant and statistically significant (P < 0.05). After treatment, the skin temperature, skin color, humidity, edema, pus volume, pus color, pus quality, and pus taste scores in the Chinese medicine external application group were lower than those in the Western medicine control group, and the difference was significant and statistically significant (P < 0.05); indicating that Chinese medicine external application treatment is effective and the effect is better than that of the Western medicine control group.

[0092] (2) The comparison results of clinical efficacy after treatment are shown in Table 3:

[0093] Table 3

[0094]

[0095] The results of the efficacy of the two groups are as follows: 8 cases were cured, 15 cases were markedly effective, 7 cases were effective, and 0 cases were ineffective in the Chinese medicine external application group; 3 cases were cured, 13 cases were markedly effective, 14 cases were effective, and 0 cases were ineffective in the Western medicine control group. After treatment, the total effective rate of the Chinese medicine external application group was 76.7%, and that of the Western medicine control group was 53.3%. After non-parametric test, Z = -2.274, P = 0.023 < 0.05, there was a significant difference in efficacy between the two groups (P < 0.05), which was statistically significant. The efficacy of the Chinese medicine external application group was better.

[0096] (3) Comparison of inflammatory factors before and after treatment: IL-6, PCT, CRP and TNF-α are shown in Table 4:

[0097] Table 4

[0098]

[0099] Note: Inter-group comparison after treatment: △P<0.05; Intra-group comparison before and after treatment: *P<0.05.

[0100] Before treatment, there was no significant difference in the baseline levels of interleukin IL-6, PCT, CRP, and TNF-α between the two groups of patients (P>0.05). After treatment, the levels of IL-6, PCT, CRP, and TNF-α in the two groups were lower than before treatment, and the difference was significant and statistically significant (P<0.05). This shows that both treatments have produced certain clinical effects. After treatment, the levels of IL-6, PCT, CRP, and TNF-α in the Chinese medicine external application group were lower than those in the control group, and the difference was significant and statistically significant (P<0.05). This shows that the Chinese medicine external application group has a better clinical effect in reducing inflammatory factors.

[0101] (4) Safety indicators before and after treatment: blood routine, liver and kidney function comparison results are shown in Table 5:

[0102] Table 5

[0103]

[0104] Comparison between the two groups before treatment: p<0.05△Comparison between the two groups after treatment: p<0.05●Comparison before and after treatment within the group: p<0.05■

[0105] Before treatment, there was no significant difference in WBC, RBC, ALT, AST, Cre, and Urea data between the two groups (P>0.05), which showed that the drugs were comparable. After treatment, there was no significant difference in WBC, RBC, ALT, AST, Cre, and Urea between the two groups compared with those before treatment (P>0.05). After treatment, there was no significant difference in WBC, RBC, ALT, AST, Cre, and Urea between the two groups compared with those before treatment (P>0.05). In summary, the drug is safe.

[0106] 2. Experiment on the healing effect of skin wound in diabetic mice

[0107] 2.1 Experimental drugs: Traditional Chinese medicine composition paste was used.

[0108] 2.2 Experimental process: Male 6-week-old C57BL / 6 mice were selected and adaptively raised for one week. After 4 weeks of feeding with diabetic feed, they were injected with 100 mg / kg streptozotocin (STZ) twice. Fasting blood glucose was measured three days later. If the blood glucose was greater than 16.7 mmol / L, the diabetic model was successfully established and included in the subsequent experiments. On the second day, the hair on the back of the mice was removed and the skin was prepared. On the third day, the back of the mice was disinfected and a circular open wound with a diameter of 6 mm × 6 mm was cut with ophthalmic scissors to construct a diabetic mouse skin wound model. They were randomly divided into a diabetic wound model group (Model) and a Chinese medicine intervention group (JJS), with 8 mice in each group; 8 male C57BL / 6 mice (normal mice of the same genetic strain) were selected as the blank control group (Con). The blank control group (Con) and the diabetic wound model group (Model) were given normal saline, and the Chinese medicine intervention group (JJS) was given a Chinese medicine composition paste for external treatment for one week. The changes in the physiological condition of the mice and the wounds were observed every day, and the wound area on days 0 and 7 was measured by ImageJ software. The wound healing rate was calculated using the formula: Wound healing rate (%) = (A 0 -A t ) / A 0 × 100%, where A 0 is the initial wound area, A t The wound area was measured; the wound sections of the mouse skin were stained with hematoxylin and eosin (HE) to observe the effect of the Chinese medicine paste on the wound healing and pathological lesions after intervention; the test results are as follows Figure 1 to Figure 2 shown.

[0109] Figure 1 The figure is a schematic diagram of the wound healing results. Compared with the blank control group mice, the wound healing of the diabetic wound model group mice was significantly delayed (P < 0.01); after external application of the Chinese medicine composition paste, the wound healing speed of the mice was significantly improved (P < 0.05).

[0110] HE staining was used to observe the overall healing of the skin wounds and the degree of inflammatory cell infiltration in each group of mice after 7 days of treatment. Figure 2 As shown, Figure 2 The following is a schematic diagram of the HE staining results of the skin wounds of mice in each group. The skin tissue structure of the mice in the blank control group (Con) was relatively intact, with less inflammatory cell infiltration; the viscous secretions at the wound site of the mice in the diabetic wound model group (Model) increased, with a large number of inflammatory cells infiltrating, and the epidermis was significantly thickened. After the treatment with the Chinese medicine paste, the boundary between the epidermis and the dermis became clear, the epidermis became thinner, and the degree of inflammation and edema at the wound site was significantly reduced.

[0111] 3. Anti-inflammatory effect test on RAW264.7 macrophages

[0112] 3.1 Experimental drugs: Aqueous extracts of traditional Chinese medicine compositions were used.

[0113] A Chinese medicine composition (9g of Xuanming powder, 9g of talc (powder), 9g of calamine (powder), 9g of sophora flavescens (powder), 9g of raw rhubarb (powder), 3g of peony bark (powder), 3g of white peony bark (powder), 9g of cnidium monnieri (powder), 9g of kochia scoparia (powder), 9g of gypsum (powder), and 9g of mint (powder)) was decocted with water, the decoction was passed through gauze, and ethanol was added for precipitation (1L of decoction + 3 / 4 liter of 95% concentration alcohol), stirred for 10min, and allowed to stand at room temperature overnight. On the next day, the supernatant was concentrated into an extract after centrifugation at 6000 rpm, quantified, vacuum dried, and dissolved in distilled water to obtain an aqueous extract of the Chinese medicine composition, which was directly used for cell experiments.

[0114] 3.2 Experimental procedure: RAW264.7 mouse macrophages were cultured at 37°C and 5% CO 2 Take the logarithmic growth phase RAW264.7 cells and adjust the density to 10 6 / mL were inoculated in 6-well plates and cultured for 24 hours, then divided into control group, LPS group (100ng / mL), LPS (100ng / mL) + JJS (10μg / mL) group, and LPS (100ng / mL) + JJS (20μg / mL) group. The changes in the mRNA levels of IL-6 and TNF-α, the hallmark inflammatory genes of macrophage M1, were detected by qPCR.

[0115] 3.3 Experimental results: The results are as follows Figure 3 and Figure 4 As shown, Figure 3 This is a schematic diagram of the results of qPCR detection of changes in the mRNA levels of IL-6, a signature inflammatory gene of the M1 macrophage type. Figure 4 This is a schematic diagram of the results of detecting the changes in the mRNA level of TNF-α, a signature inflammatory gene of macrophage M1, by qPCR. The Chinese medicine composition can significantly inhibit the gene expression of IL-6 and TNF-α in primary macrophages and has an anti-inflammatory effect. con represents blank control, LPS represents lipopolysaccharide, JJS-L represents a low dose of the Chinese medicine composition, and JJS-H represents a high dose of the Chinese medicine composition.

[0116] Typical Case 1

[0117] Patient: Xu, age: 85 years old, gender: female, marital status: married. He was admitted to the hospital for "redness and swelling on the dorsum of the right foot for more than 1 week". Physical examination: clear mind, calm breath, slightly coarse breath sounds in both lungs, no obvious murmurs or wheezing, heart rate 78 beats / min, irregular rhythm, no obvious murmurs in the auscultation area of ​​each valve, soft abdomen, no tenderness and rebound pain, no guard muscle tension, no gastrointestinal peristaltic waves. The dorsum of the right foot is red and swollen, tender (++), high skin temperature, no obvious fluctuation, no obvious ulcer, double dorsalis pedis artery (-) double posterior tibial artery (-) double popliteal artery (-) double femoral artery (+). Tongue: red, fur: yellow and greasy, pulse: stringy and slippery. Past history of type 2 diabetes, lower extremity arteriosclerosis obliterans, hypertension stage 3 (high risk), coronary artery atherosclerosis, arrhythmia, lacunar cerebral infarction, etc. Western medicine diagnosis: diabetic foot. TCM diagnosis: gangrene, damp-heat congestion syndrome. On the basis of basic treatment, the Chinese medicine composition paste prepared in Example 1 of the present invention was applied externally once a day for 24 hours each time. After a follow-up visit 2 weeks later, the patient's redness and swelling disappeared, the pain disappeared, and the skin temperature was normal.

[0118] Typical Case 2

[0119] Patient: Pan, age: 57 years old, gender: male, marital status: married, was diagnosed with "right foot ulcer with pain for more than 2 months". Physical examination: clear mind, calm breath, slightly coarse breath sounds in both lungs, no obvious murmurs or wheezing, heart rate 70 beats / min, rhythm is still regular, no obvious murmurs in the auscultation area of ​​each valve, soft abdomen, no tenderness and rebound pain, no guard muscle tension, no gastrointestinal peristaltic wave. The right foot was ulcerated, the wound surface was yellow and rotten, with obvious exudation and foul odor, tenderness (++), redness and swelling around the wound, high skin temperature, bilateral dorsal A (-), bilateral posterior tibial A (-), bilateral popliteal artery (+), bilateral femoral artery (+). Tongue: red, fur: yellow and greasy, pulse: rapid and strong. Past history of type 2 diabetes, lower extremity arteriosclerosis obliterans with gangrene, hypertension grade 3 (high risk), gout (personal history), etc. Western medicine diagnosis: diabetic foot. TCM diagnosis: gangrene, damp-heat congestion syndrome. On the basis of basic treatment, the Chinese medicine composition paste prepared in Example 1 of the present invention was applied externally once a day for 24 hours each time. After 2 weeks of follow-up, the patient's redness and swelling were alleviated, the pain was reduced, the purulent exudation was reduced, the wound surface was reduced, and the skin temperature was reduced.

[0120] The Chinese medicine composition used in the present invention can be used in actual clinical practice, and can achieve good effects in relieving symptoms such as redness, swelling, heat and pain of diabetic foot. The present invention is economical and convenient, has little side effects, has definite efficacy, no toxic side effects, low cost, and is easy to promote and apply.

[0121] The above is only a preferred embodiment of the present invention, and does not limit the present invention in any form. Although the present invention has been disclosed as a preferred embodiment, it is not used to limit the present invention. Any technician familiar with this patent can make some changes or modify the technical contents suggested above into equivalent embodiments without departing from the scope of the technical solution of the present invention. However, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention without departing from the content of the technical solution of the present invention still fall within the scope of the solution of the present invention.

Claims

1. A Chinese medicine composition for treating diabetic foot, characterized in that: The invention is prepared from the following components in parts by weight: 9-30 parts of xuanming powder, 9-15 parts of talc, 9-15 parts of calamine, 9-15 parts of sophora flavescens, 9-20 parts of raw rhubarb, 3-12 parts of peony bark, 3-12 parts of white peony root, 9-15 parts of cnidium monnieri, 9-15 parts of kochia scoparia, 9-20 parts of gypsum and 9-15 parts of mint.

2. The Chinese medicine composition for treating diabetic foot according to claim 1, characterized in that: The Chinese medicine composition for treating diabetic foot is prepared from the following components in parts by weight: 9 parts of Xuanming powder, 9 parts of talc, 9 parts of calamine, 9 parts of sophora flavescens, 9 parts of raw rhubarb, 3 parts of peony bark, 3 parts of white peony root, 9 parts of cnidium monnieri, 9 parts of kochia scoparia, 9 parts of gypsum, and 9 parts of mint.

3. The Chinese medicine composition for treating diabetic foot according to claim 1, characterized in that: The Chinese medicine composition for treating diabetic foot is prepared from the following components in parts by weight: 30 parts of Xuanming powder, 15 parts of talc, 15 parts of calamine, 15 parts of sophora flavescens, 20 parts of raw rhubarb, 12 parts of peony bark, 12 parts of white peony root, 15 parts of cnidium monnieri, 15 parts of kochia scoparia, 20 parts of gypsum, and 15 parts of mint.

4. The Chinese medicine composition for treating diabetic foot according to claim 1, characterized in that: The Chinese medicine composition for treating diabetic foot is prepared from the following components in parts by weight: 21 parts of Xuanming powder, 12 parts of talc, 12 parts of calamine, 12 parts of sophora flavescens, 15 parts of raw rhubarb, 9 parts of peony bark, 9 parts of white peony root, 12 parts of cnidium monnieri, 12 parts of kochia scoparia, 15 parts of gypsum, and 12 parts of mint.

5. Use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for treating diabetic foot.

6. A pharmaceutical preparation, characterized in that The invention is prepared from the Chinese medicine composition according to any one of claims 1 to 4.

7. The pharmaceutical preparation according to claim 6, characterized in that The dosage form of the pharmaceutical preparation is selected from pastes, ointments, creams, gels, paints, plasters, and plasters.

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