Traditional Chinese medicine composition for treating diabetic foot and its uses

Abstract

The present invention relates to the field of traditional Chinese medicine, and specifically to a traditional Chinese medicine composition for treating diabetic foot, which is made of the following components in parts by weight: 1-5 parts of Rheum palmatum, 5-25 parts of Scutellaria baicalensis, 5-25 parts of Phellodendron amurense, 10-50 parts of Isatis indigotica, 5-25 parts of Forsythia suspensa, 5-30 parts of Paris vietnamensis, 10-50 parts of Commelina communis, 3-15 parts of Glycyrrhiza uralensis, 2-10 parts of Coptis chinensis, 5-25 parts of Crataegus pinnatifida, 3-15 parts of Polygonum cuspidatum. The traditional Chinese medicine composition of the present invention has the efficacy of resolving dampness and anti-inflammatory. It has been confirmed by years of clinical application and pharmacological research that it can be used for the treatment of diabetic foot, improve the inflammatory reaction, and has the advantages of definite curative effect, no toxic and side effects, low cost and convenient application.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine compound preparations, and specifically, to a traditional Chinese medicine composition and its use for alleviating the acute inflammation of diabetic foot and promoting the healing of ulcer wounds. Background Art

[0002] Diabetic foot is one of the main causes of disability and death in diabetic patients, and it is also a major public health problem that causes a heavy burden on society. The main pathological manifestations of diabetic foot are the destruction of the skin and its deep tissues distal to the ankle joint of patients, often complicated with infection and / or different degrees of arterial occlusion in the lower extremities. In severe cases, the muscle and bone tissues are involved, and inflammatory lesions such as abscess, tendinitis, and osteomyelitis occur. Diabetic foot ulcer is the most common clinical manifestation of diabetic foot and the main cause of amputation in diabetic patients. More than 85% of diabetic patients' amputations are due to diabetic foot ulcers, and 4 out of every 5 ulcers start from external trauma. Therefore, the timely control of diabetic foot inflammation and the early intervention in ulcer treatment are the keys to treating diabetic foot.

[0003] Grading diagnostic criteria for diabetic foot: Currently, the widely accepted grading methods in clinical practice mainly include Wagner grading and Texas grading. However, due to the complex condition of diabetic foot, with large differences in vascular lesions, neuropathy, the degree of infection, the destruction of soft tissues and bone tissues, etc., no grading method can be perfect. Wagner grading This grading method was first proposed by Meggitt in 1976 and later popularized by Wagner. It is the most widely used grading method in current clinical and scientific research. The grading method is as follows:

[0004]

[0005] Currently, the clinical treatment of diabetic foot mainly focuses on controlling blood sugar, anti-inflammation (glucocorticoids), anti-infection (antibiotics), and debridement. The use of hormones can easily bring serious adverse reactions to patients, and the repeated use of antibiotics can easily cause drug resistance of the infected bacteria, further aggravating the pathological process of diabetic foot. Therefore, further exploring the pathogenesis of diabetic foot and finding effective drugs for preventing and treating diabetic foot are still medical problems that need to be solved urgently at present, and it has great significance for the clinical treatment of diabetic foot. Summary of the Invention

[0006] The first object of the present invention is to provide a traditional Chinese medicine composition for treating diabetic foot, specifically, a traditional Chinese medicine complex mainly manifested by improving the immune inflammatory response of diabetic foot.

[0007] The second object of the present invention is to provide the application of the traditional Chinese medicine composition in the preparation of drugs for treating diabetic foot.

[0008] To achieve the above object, the present invention adopts the following technical solutions:

[0009] The present invention analyzes patients with diabetic foot accompanied by systemic inflammatory response admitted to the Vascular Medicine Ward of Shanghai Integrated Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine. Among them, patients with the main syndrome type of damp-heat toxin excess syndrome can effectively reduce the systemic inflammatory level of patients by using traditional Chinese medicine compound treatment, so as to achieve the effect of treating diabetic foot. Based on this, combined with clinical practice experience and large-sample data analysis and observation, following the principle of syndrome differentiation and treatment of traditional Chinese medicine, a traditional Chinese medicine compound capable of treating diabetic foot is optimized and screened.

[0010] In the diagnostic and treatment standards of traditional Chinese medicine, diabetic foot belongs to the syndrome of damp-heat toxin excess. The affected foot is locally swollen, hot, with flushing or purple-red skin color. When touching the affected foot, the skin temperature is high or there is subcutaneous fluid accumulation and a sense of fluctuation. A large amount of foul-smelling pus can overflow when incised, and the surrounding area shows solid swelling. The lesion develops rapidly and can involve the entire foot and calf in severe cases. The patient's tongue is red and crimson, the tongue coating is yellow and greasy, and the pulse is slippery and rapid. The dorsalis pedis pulse can be felt or weakened, and the local skin temperature is on the high side. Professor Xi Jiuyi, a famous traditional Chinese medicine doctor in Shanghai and the founder of the Vascular Medicine Department and the Institute of Integrated Traditional Chinese and Western Medicine Vascular Diseases of our hospital, defined that qi and yin deficiency and dampness stagnation and tendon damage are the main pathogenesis of diabetic foot. In view of this syndrome and its pathogenesis characteristics, a treatment principle mainly based on dampness elimination and inflammation reduction is proposed. Under the guidance of this theory, combined with its own clinical practice, it is expected to screen out a traditional Chinese medicine compound preparation capable of treating diabetic foot.

[0011] In the first aspect of the present invention, there is provided a traditional Chinese medicine composition for treating diabetic foot, which is made of the following components in parts by weight: 1-5 parts of Rheum palmatum, 5-25 parts of Scutellaria baicalensis, 5-25 parts of Phellodendron amurense, 10-50 parts of Isatis tinctoria, 5-25 parts of Forsythia suspensa, 5-30 parts of Paris vietnamensis, 10-50 parts of Commelina communis, 3-15 parts of Glycyrrhiza uralensis, 2-10 parts of Coptis chinensis, 5-25 parts of Crataegus pinnatifida, 3-15 parts of Polygonum cuspidatum.

[0012] Preferably, the traditional Chinese medicine complex for treating diabetic foot is made of the following components in parts by weight: 1 part of Rheum palmatum, 5 parts of Scutellaria baicalensis, 5 parts of Phellodendron amurense, 10 parts of Isatis tinctoria, 5 parts of Forsythia suspensa, 5 parts of Paris vietnamensis, 10 parts of Commelina communis, 3 parts of Glycyrrhiza uralensis, 2 parts of Coptis chinensis, 5 parts of Crataegus pinnatifida, 3 parts of Polygonum cuspidatum.

[0013] More preferably, the traditional Chinese medicine complex for treating diabetic foot is made of the following components in parts by weight: 2 parts of Rheum palmatum, 10 parts of Scutellaria baicalensis, 10 parts of Phellodendron amurense, 20 parts of Isatis tinctoria, 10 parts of Forsythia suspensa, 10 parts of Paris vietnamensis, 20 parts of Commelina communis, 6 parts of Glycyrrhiza uralensis, 4 parts of Coptis chinensis, 10 parts of Crataegus pinnatifida, 6 parts of Polygonum cuspidatum.

[0014] More preferably, the traditional Chinese medicine complex for treating diabetic foot is made from the following components in parts by weight: 3 parts of Rheum officinale, 15 parts of Scutellaria baicalensis, 15 parts of Phellodendron amurense, 30 parts of Isatis indigotica, 15 parts of Forsythia suspensa, 30 parts of Paris vietnamensis, 30 parts of Commelina communis, 9 parts of Glycyrrhiza uralensis, 6 parts of Coptis chinensis, 15 parts of Crataegus pinnatifida, 9 parts of Polygonum cuspidatum.

[0015] Most preferably, the traditional Chinese medicine complex for treating diabetic foot is made from the following components in parts by weight: 4 parts of Rheum officinale, 20 parts of Scutellaria baicalensis, 20 parts of Phellodendron amurense, 40 parts of Isatis indigotica, 20 parts of Forsythia suspensa, 20 parts of Paris vietnamensis, 40 parts of Commelina communis, 12 parts of Glycyrrhiza uralensis, 8 parts of Coptis chinensis, 20 parts of Crataegus pinnatifida, 12 parts of Polygonum cuspidatum.

[0016] Most preferably, the traditional Chinese medicine complex for treating diabetic foot is made from the following components in parts by weight: 5 parts of Rheum officinale, 25 parts of Scutellaria baicalensis, 25 parts of Phellodendron amurense, 50 parts of Isatis indigotica, 25 parts of Forsythia suspensa, 25 parts of Paris vietnamensis, 50 parts of Commelina communis, 15 parts of Glycyrrhiza uralensis, 10 parts of Coptis chinensis, 25 parts of Crataegus pinnatifida, 15 parts of Polygonum cuspidatum.

[0017] In the second aspect of the present invention, there is provided an application of the traditional Chinese medicine composition as described above in the preparation of a drug for treating diabetic foot.

[0018] Preferably, the drug is a drug for treating diabetic foot of the syndrome type of exuberant damp-heat toxin with the main treatment of resolving dampness and clearing inflammation.

[0019] The traditional Chinese medicine composition of the present invention is used for preparing an immune-inflammatory disorder mainly manifested as the syndrome type of exuberant damp-heat toxin with the treatment principle of resolving dampness and clearing inflammation in the treatment of diabetic foot.

[0020] In the third aspect of the present invention, there is provided a pharmaceutical preparation for treating diabetic foot, which is made from the traditional Chinese medicine composition as described above. The pharmaceutical preparation is prepared into a commonly used pharmaceutical dosage form by a conventional preparation method in the art.

[0021] Preferably, the pharmaceutical preparation is a decoction, a granule, etc.

[0022] More preferably, the pharmaceutical preparation further includes pharmaceutically acceptable excipients.

[0023] The traditional Chinese medicine composition provided by the present invention is made from Rheum officinale, Scutellaria baicalensis, Phellodendron amurense, Isatis indigotica, Forsythia suspensa, Paris vietnamensis, Commelina communis, Glycyrrhiza uralensis, Coptis chinensis, Crataegus pinnatifida and Polygonum cuspidatum. Based on years of clinical practice, according to clinical feedback, under the guidance of traditional Chinese medicine theory, through syndrome differentiation and analysis, the herbs are carefully selected and formulated. In this prescription, Scutellaria baicalensis, Phellodendron amurense, Coptis chinensis and Rheum officinale are the monarch herbs for clearing heat, cooling blood and purging fire. Isatis indigotica and Forsythia suspensa are the minister herbs for clearing heat, cooling blood and anti-inflammation. Commelina communis, Paris vietnamensis, Polygonum cuspidatum and Crataegus pinnatifida are the assistant herbs for clearing heat, promoting diuresis and removing stasis. Glycyrrhiza uralensis is the envoy herb for coordinating the actions of all the other herbs.

[0024] The monarch drug Scutellaria baicalensis, also known as Radix Scutellariae and Radix Scutellariae Baicalensis, is a perennial herbaceous plant of the genus Scutellaria in the Lamiaceae family. It is bitter in taste and cold in nature, and has the effects of clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and preventing miscarriage. Modern pharmacological studies have found that Scutellaria baicalensis has antibacterial, antiviral, anti-inflammatory and anti-allergic, antiplatelet aggregation and lipid-lowering, anti-cancer, and liver-protecting, cholagogic, antioxidant effects. Modern pharmacological studies have found that after intragastric administration of baicalein, baicalin, and wogonin in the 70% ethanol extract of Scutellaria baicalensis, it can inhibit the increased peritoneal exudation in mice caused by acetic acid and the foot swelling in rats caused by 48 / 80 (a compound name, produced by Sigma). At the same time, it also has a good inhibitory effect on adjuvant arthritis in rats. Intravenous injection of the ethanol extract of Scutellaria baicalensis can cause a decrease in blood pressure in anesthetized dogs, showing a blood pressure-lowering effect. The water decoction of Scutellaria baicalensis can inhibit the growth of fungi at low concentrations and exert antibacterial, antiviral, and anti-ulcer effects at high concentrations. The ether extract of Scutellaria baicalensis has cytotoxic effects on mouse leukemia L1210 cancer cells, with a median effective dose of 10.4 mg / ml. The median effective dose of baicalein II on mouse L1210 cells is 1.5 μg / ml. Baicalin, baicalein, and wogonin have no significant effect on L1210.

[0025] The monarch drug Phellodendron amurense Rupr., bitter in taste and cold in nature, is the dried bark of Phellodendron chinense Schneid., a plant of the Rutaceae family. It has the effects of clearing heat and drying dampness, purging fire and removing steaming, and detoxifying and treating sores. The bark of Phellodendron amurense Rupr. contains alkaloids such as berberine, jatrorrhizine, magnoflorine, phellodendrine, N-methylhordenine, palmatine, and menisperine, and also contains phellodendrone, phellodendrolide, dictamnolide, phellodendronic acid, chloroenchroic acid, 7-dehydrostigmasterol, β-sitosterol, and campesterol. Modern pharmacological studies have found that Phellodendron amurense Rupr. has antibacterial, anti-inflammatory, antiviral, and immunosuppressive effects. The decoction, water extract, or ethanol extract of Phellodendron amurense Rupr. has a strong antibacterial effect on pyogenic bacteria, especially on positive cocci such as Staphylococcus aureus, epidermidis, and Streptococcus pyogenes, and also has an inhibitory effect on Pseudomonas aeruginosa, but the effect is weaker. The water extract of Phellodendron amurense Rupr. has obvious anti-inflammatory effects on ear swelling in mice caused by croton oil and increased capillary permeability in the peritoneal cavity of mice caused by acetic acid. When administered to mice inoculated with herpes simplex virus and developing herpes, compared with the acyclovir control group and the blank control group, it was found that the group administered with the water extract of Phellodendron amurense Rupr. could delay the onset time and spread time of herpes symptoms, prolong the survival time of mice, and significantly reduce the mortality rate of mice. The water decoction of Phellodendron amurense Rupr. can also significantly inhibit the delayed-type hypersensitivity reaction in mice induced by dinitrofluorobenzene. The possible mechanism is to reduce the production and secretion of cytokines such as serum IFN-IL-1, TNF-α, and IL-2, thereby inhibiting the immune response and reducing inflammatory damage. In addition, the berberine component of Phellodendron amurense Rupr. has an inhibitory effect on restraint water immersion stress-induced gastric ulcers in mice.

[0026] Coptis chinensis Franch., a perennial herb belonging to the Ranunculaceae family and the Coptis genus, is a heat-clearing drug. It was first recorded in "Shennong Ben Cao Jing" and listed as a superior-grade medicine. It has the effects of clearing heat and drying dampness, purging fire and detoxifying. Its taste is extremely bitter when taken orally. There is a common saying that "even a mute who eats Coptis chinensis has bitterness that he cannot express", which vividly describes its taste. The main components of Coptis chinensis are berberine, coptisine, palmatine, magnoflorine and other chemical components. Its pharmacological effects include anti-inflammatory, antipyretic, anti-bacterial toxin, anti-diarrheal, anti-pathogen, sedative and hypnotic, hypoglycemic, anti-ulcer and anti-tumor effects. Berberine hydrochloride has inhibitory effects on both acute and chronic inflammation. For example, berberine has obvious inhibitory effects on xylene-induced pedal swelling, ear swelling, increased capillary permeability in the abdominal cavity of mice caused by acetic acid, and chronic cotton ball granuloma. Berberine can significantly reduce the activity of phospholipase A2 (PLA2) in neutrophils in inflammatory tissues and the content of prostaglandin E2 (PGE2), reducing the generation of inflammatory mediators. Berberine can counteract the toxins of a variety of pathogenic microorganisms, improve the body's tolerance to bacterial endotoxins, and can counteract diarrhea caused by Escherichia coli. Coptis chinensis and berberine hydrochloride have inhibitory effects on a total of 16 strains of 7 pathogenic bacteria, including Streptococcus hemolyticus, Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Shigella dysenteriae, Klebsiella oxytoca and Salmonella typhi. Coptisine and berberine are both quaternary ammonium alkaloids and are not easily permeable through the blood-brain barrier, so their central inhibitory effects are relatively weak; while tertiary amine alkaloids such as tetrahydrocoptisine and tetrahydroberberine have enhanced central inhibitory effects because they are easily permeable through the blood-brain barrier. Decoction of Coptis chinensis and intragastric administration of berberine can lower the blood sugar of normal or hyperglycemic animals, and there is a certain dose-effect relationship. Berberine can reduce the glycogen content in the liver and diaphragm, inhibit glycogenolysis with alanine as the substrate, increase the content of lactic acid in the blood, and does not affect the secretion and release of insulin, nor the number and affinity of insulin receptors on the liver cell membrane. Therefore, it is speculated that the hypoglycemic effect of berberine is produced by inhibiting glycogenolysis or promoting glycolysis. Coptis chinensis and berberine hydrochloride have the effect of anti-experimental gastric ulcer. The mechanism of action is related to their anti-Helicobacter pylori and inhibition of gastric acid secretion. The anti-nasopharyngeal cancer cell effect of Coptis chinensis is mainly related to its cytotoxic effect, while the anti-gastric cancer effect of berberine hydrochloride is related to promoting the differentiation of cancer cells.

[0027] The monarch drug, rhubarb, is a collective term for various perennial plants of the genus Rheum in the Polygonaceae family, which has the effects of purging accumulation, clearing damp-heat, purging fire, cooling blood, removing stasis, and detoxifying. Modern pharmacology has confirmed that rhubarb has the effects of laxation, protecting the liver and gallbladder, protecting the intestinal mucosal barrier, promoting immune system regulation, antibacterial, anti-tumor, and regulating the central nervous system and cardiovascular and cerebrovascular systems. The main component of rhubarb that plays a laxative role is anthraglycoside, among which sennoside has the most obvious laxative effect. After entering the body, the bound anthraglycoside generally enters the large intestine in an unabsorbed state and is decomposed into anthrone under the influence of intestinal bacterial enzymes, which stimulates the intestinal mucosa, reduces the absorption of sodium ions and water in the intestine, increases the intestinal volume, promotes intestinal peristalsis, and achieves the effect of causing diarrhea. In chronic ulcerative colitis, the rhubarb decoction can effectively improve cellular immune function, promote the proliferation ability of normal cells, activate NK cells, and enhance the killing ability of NK cells against lesions. Rhein, emodin, etc. in rhubarb have strong inhibitory effects on various bacterial genera, especially Staphylococcus aureus. The main reason may be that rhubarb inhibits bacterial respiration, the oxidation and dehydrogenation reactions of intermediate metabolites of sugar metabolism. In addition, the content and activity of kinases in some tumor cells will increase significantly, and emodin can have a strong inhibitory effect on some kinases, selectively inhibiting activated oncogenes. Rhein has a good inhibitory effect on platelet aggregation and intracellular calcium influx, which is beneficial to improving blood rheology, enhancing the deformability of red blood cells, and increasing the level of cyclic adenosine monophosphate in cells.

[0028] The ministerial drug, radix isatidis, is the dried root of Isatis indigotica Fort., a plant of the Cruciferae family. Radix isatidis has the effects of clearing heat, detoxifying, cooling blood, and relieving sore throat. Radix isatidis is commonly used for epidemic febrile disease with maculae, epidemic encephalitis B, purple and dark tongue, erysipelas, sore throat, sores, carbuncles, hepatitis, influenza, epidemic encephalitis B, coma with hematemesis and epistaxis, pharyngeal swelling, herpes, acute and chronic hepatitis, osteomyelitis, etc. Modern pharmacology shows that radix isatidis has the effects of antibacterial, antiviral, anti-endotoxin, anti-tumor, anti-inflammatory, and promoting immune function. Radix isatidis has inhibitory effects on Staphylococcus aureus, Streptococcus pneumoniae, Microsporum lanosum, Trichophyton mentagrophytes, Trichophyton rubrum, Staphylococcus epidermidis, Sarcina octa, Epidermophyton floccosum, Haemophilus influenzae, Trichophyton violaceum, Trichophyton mentagrophytes, Streptococcus pneumoniae, Escherichia coli, Salmonella typhi, Bacillus subtilis, Neisseria meningitidis, etc. Radix isatidis and its extracts have inhibitory effects on hepatitis B virus, influenza A virus, herpes simplex virus, mumps virus, cytomegalovirus, Coxsackie virus, influenza virus, influenza virus, inhibiting infection and proliferation. At the same time, animal studies have found that the 70% ethanol extract of radix isatidis also shows certain anti-inflammatory effects in chronic inflammation models such as cotton pellet granuloma in rats.

[0029] The herb Forsythia suspensa, originating from the Oleaceae family, has a faint aroma and a bitter taste. It possesses heat-clearing and detoxifying properties, dispersing stagnation, and reducing swelling. Recent modern pharmacological studies of Forsythia suspensa have revealed its antibacterial, antipyretic, anti-inflammatory, antiviral, anti-endotoxin, hepatoprotective, and anti-tumor effects. A decoction of this traditional Chinese medicine was prepared and its in vitro antibacterial activity was observed using the two-fold agar dilution method. The decoction alone demonstrated varying degrees of antibacterial activity against 20 clinical strains of ESBLs (extended-spectrum β-lactamases)-producing Escherichia coli. In vitro anti-human cytomegalovirus (HCMV) and cytotoxicity studies of Forsythia suspensa and its main active ingredient, quercetin, revealed that quercetin exhibited superior anti-human cytomegalovirus efficacy compared to guanidine-clovir and Forsythia suspensa. Its cytotoxicity was comparable to that of Forsythia suspensa and lower than that of guanidine-clovir. When xylene (0.03 mL / mouse) was applied to both sides of the right ear of mice to induce inflammation, Forsythia suspensa volatile oil significantly inhibited xylene-induced ear swelling in mice. In addition, different extracts were made from the fruit shell and seeds of Forsythia suspensa, and the ear swelling of mice induced by xylene or croton oil was studied. It was found that the water decoction of Forsythia suspensa fruit shell, macroporous resin adsorbent and Forsythia suspensa polyphenols were the main effective parts of Forsythia suspensa's anti-inflammatory effect.

[0030] The adjuvant herb Commelina communis, also known as Green Bamboo, Green Butterfly, and Light Bamboo Leaf, is an annual, loosely spreading herb belonging to the Commelinaceae family, Commelina order. It has a sweet, slightly bitter flavor and a cold nature. It clears heat, detoxifies, and acts as a diuretic. It is an excellent remedy for swelling, diuresis, clearing heat and detoxifying. It is also effective for treating styes, pharyngitis, tonsillitis, cervical erosion, and snake bites. Modern pharmacological studies have shown that Commelina communis can stimulate the uterus, constrict blood vessels, and shorten blood clotting time.

[0031] The adjuvant herb Herba Hecheii, also known as Seven-leaf Lotus, belongs to the Trillium family. It is bitter, cooling, and mildly toxic. It possesses anti-cancer, anti-inflammatory, analgesic, heat-clearing, anticonvulsant, and antitussive and antiasthmatic properties. Modern pharmacology demonstrates Herba Hecheii's antibacterial, spermicidal, sedative, analgesic, antiasthmatic, and antitussive properties. Both its aqueous extract and decoction exhibit in vitro inhibitory effects against Salmonella typhi, Salmonella paratyphi A, Shigella flexneri, and Shigella flexneri. The aqueous extract exhibits stronger antibacterial activity than the decoction. Its 70% ethanol extract exhibits spermicidal effects against rat, mouse, and human sperm. Vaginal administration of 100 mg of the extract to rabbits resulted in a 60% fertilization inhibition rate. Oral administration of the Herba Hecheii alcohol extract to mice reduced spontaneous activity and exhibited a significant sedative effect. It also exhibited significant analgesic activity using both electrical stimulation and hot plate tests. Furthermore, in vivo studies have shown that oral administration of a Herba Hecheii decoction to guinea pigs exhibited significant antiasthmatic effects.

[0032] The adjuvant drug Polygonum cuspidatum, a perennial herbaceous plant of the family Polygonaceae and the genus Reynoutria, has the effects of promoting blood circulation, dissipating stasis, dredging channels, and relieving cough. Modern pharmacological research shows that Polygonum cuspidatum has the effects of dilating blood vessels, anti-thrombosis, reducing blood lipid, anti-lipid peroxidation, antibacterial, antiviral, improving microcirculation, anti-inflammatory, anti-shock, and strengthening the heart. The active ingredient piceid in Polygonum cuspidatum has a significant effect of dilating blood vessels and reducing blood pressure. When normal rats were intragastrically administered with 200 mg / kg of piceid for 7 consecutive days, the results showed that piceid could significantly reduce the contents of serum cholesterol and triglyceride, having the effect of reducing blood lipid. Using the in-vitro drug-base method to observe the antibacterial effects of Compound Polygonum cuspidatum Liquid (Polygonum cuspidatum, alum, borneol, etc.) against four clinically pathogenic fungi such as Trichophyton rubrum, Microsporum gypseum, Candida albicans, and Cladosporium pedrosoi. The results showed that the drug-base of Polygonum cuspidatum with a concentration of more than 40% had antibacterial effects. Applying or orally administering Polygonum cuspidatum tannin on the ears of mice could significantly inhibit the auricle swelling induced by croton oil. Applying hot compress and external washing with fresh Polygonum cuspidatum had significant curative effects on joint pain and also had a certain protective effect on the gastric ulcers induced by indomethacin in rats. In addition, the combination of Polygonum cuspidatum and other drugs is also widely used in burns, scalds, infections, radioactive dermatitis, etc.

[0033] The adjuvant drug Hawthorn, belonging to the genus Crataegus of the family Rosaceae, ranks first among fruits in terms of anti-aging effect. Its nucleus is hard, the pulp is thin, and the taste is slightly sour and astringent. The fruit can be eaten raw or made into preserved fruits and fruit cakes. After drying, it can be used as medicine. It is a unique tree species in China that combines medicine and fruit, having the effects of reducing blood lipid, blood pressure, strengthening the heart, and anti-arrhythmia. At the same time, it is also a good medicine for strengthening the spleen and promoting digestion, promoting digestion and resolving stagnation, promoting blood circulation and resolving phlegm, and has good curative effects on symptoms such as chest and diaphragm fullness, hernia, blood stasis, and amenorrhea. Modern pharmacology shows that Hawthorn has the effects of promoting digestion, reducing blood lipid, anti-atherosclerosis, anti-myocardial ischemia, strengthening the heart, reducing blood pressure, antioxidant, and antibacterial. Hawthorn contains ingredients such as vitamin C, and oral administration can increase appetite; Hawthorn has a regulatory effect on gastrointestinal motility function, has an inhibitory effect on the gastrointestinal smooth muscle in a spastic state, and has an excitatory effect on the smooth muscle in a relaxed state. Hawthorn flavonoids can significantly reduce the concentrations of serum total cholesterol, low-density lipoprotein cholesterol, and apolipoprotein in experimental hyperlipidemic animals, significantly increase the concentrations of high-density lipoprotein, cholesterol, and apolipoprotein A, but have little effect on triglyceride. The extracts of Hawthorn can enhance the myocardial contractility of in-vivo and in-vitro toad hearts, and the action lasts for a long time. Hawthorn and Hawthorn flavonoids have antioxidant effects, can significantly reduce the content of malondialdehyde in serum and liver, enhance the activities of superoxide dismutase in red blood cells and liver, and at the same time enhance the activity of plasma glutathione peroxidase. Hawthorn has a strong antibacterial effect on Shigella, Proteus, Escherichia coli, Staphylococcus aureus, etc.

[0034] Licorice, a plant of the legume family, has a sweet taste and a neutral nature. "Shennong Ben Cao Jing" records: "Licorice mainly treats cold and heat pathogens in the five zang-organs and six fu-organs, strengthens tendons and bones, grows muscles, increases strength, treats traumatic injuries, and detoxifies. Taking it for a long time can lighten the body and prolong life." Its effects include invigorating the spleen and replenishing qi, clearing heat and detoxifying, relieving spasm and pain, and coordinating various herbs. Licorice mainly contains triterpenoid saponins and flavonoid compounds. It has the effects of regulating heart rate, regulating the body's immune function, antibacterial and anti-allergic, and anti-ulcer. Some studies have shown that glycyrrhetinic acid can delay the onset time of arrhythmia and reduce the frequency of ventricular fibrillation, etc. The mechanism of action is to block calcium channels and limit the influx of calcium ions. Glycyrrhizin reduces prostaglandin synthesis by inhibiting the activity of the pre-synthesized enzyme PLA2, induces the production of interleukin 1 and 2, and promotes the secretion of interferon γ, thereby enhancing the activity of natural killer cells NK. Related studies have also found that licorice and its related products can reduce the serum testosterone content. Glycyrrhetinic acid can improve the morphological structure of β-cells in alloxan-induced diabetic rats and enhance the expression of insulin. In addition, the antioxidant effect of licorice and its active ingredients can effectively reduce the level of serum lipid peroxide and restore the level of related enzymes, thereby protecting β-cells.

[0035] It should be noted that in the prior art, in the compound prescription for treating diabetic foot, there is a literature prescription of Scutellaria baicalensis Georgi 15g, Coptis chinensis Franch. 10g, Phellodendron amurense Rupr. 15g, Polygonum cuspidatum Sieb. et Zucc. 15g, Rheum palmatum L. 10g, Gardenia jasminoides Ellis 15g (Zhao Lijuan et al., Analysis of the effect of Huangma tincture combined with Sanhuang anti-inflammatory prescription on the repair of diabetic foot ulcer wounds, Chinese Archives of Traditional Chinese Medicine [J], 39(10), 159-162). Decoct with water to obtain 300 mL of juice, 1 dose per day, warm it and take it twice a day in the morning and evening, and the course of treatment is 4 weeks. At the same time, Huangma tincture treatment is given. After rinsing the diabetic foot wound with normal saline, use the gauze soaked in Huangma tincture to wet compress and bandage the wound. Determine the dressing change frequency according to the exudation of the wound and the growth of granulation in the wound. After treating diabetic foot ulcers with the literature prescription combined with Huangma tincture, the levels of inflammatory factors TNF-α, IL-1, and ICAM-1 in the serum of patients decreased compared with the pre-treatment levels, the levels of VEGF and TIMP-1 in the serum increased compared with the pre-treatment levels, and the level of serum MMP-2 decreased compared with the pre-treatment level.

[0036] Compared with the literature prescription, the Chinese medicine composition of the present invention uses 1-5 parts of raw rhubarb, 5-25 parts of scutellaria, 5-25 parts of phellodendron, 10-50 parts of isatis root, 5-25 parts of forsythia, 5-30 parts of schisandra chinensis, 10-50 parts of communis, 3-15 parts of liquorice, 2-10 parts of coptis chinensis, 5-25 parts of hawthorn, and 3-15 parts of polygonum cuspidatum. The addition of raw rhubarb as the main ingredient can improve constipation in patients with diabetic foot. Isatis root and forsythia clear heat, cool blood and reduce inflammation as the auxiliary ingredients, and schisandra chinensis, communis and polygonum cuspidatum as adjuvants further give the prescription the effects of clearing heat and detoxifying, antiviral, antibacterial and lipid-lowering. Licorice and hawthorn, while having lipid-lowering effects, neutralize the bitter taste of the compound. Practical cases also preliminarily show that the Chinese medicine composition not only accelerates the healing of diabetic foot wounds and improves the overall inflammatory environment, but also has the ability to lower blood sugar in subjects. The above characteristics are not possessed by the literature prescription.

[0037] The advantages of the present invention are:

[0038] 1. The Chinese medicine composition of the present invention can be prepared into a preparation using conventional preparation methods. Pharmacological studies and clinical applications have shown that it has significant effects on improving the inflammatory response of diabetic foot and treating diabetic foot.

[0039] 2. The Chinese medicine composition of the present invention uses inexpensive raw materials, is simple to prepare, and is easy to use. After years of clinical application, it has shown good efficacy in treating diabetic foot. Given the huge number of people suffering from diabetic foot disease, and the fact that the compound preparation prepared from the Chinese medicine composition of the present invention is non-toxic and can be taken for a long time, the Chinese medicine composition provided by the present invention has good application prospects.

[0040] 3. The Chinese medicine composition of the present invention has the effect of removing dampness and relieving inflammation. After years of clinical application and pharmacological research, it has been confirmed that it can be used to treat diabetic foot and improve inflammatory response. It has the advantages of definite efficacy, no toxic side effects, low cost and easy application. DETAILED DESCRIPTION

[0041] 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.

[0042] Example 1:

[0043] Weigh 1 gram of raw rhubarb, 5 grams of scutellaria, 5 grams of phellodendron, 10 grams of isatis root, 5 grams of forsythia, 5 grams of schisandra chinensis, 10 grams of communis, 3 grams of licorice, 2 grams of coptis chinensis, 5 grams of hawthorn, and 3 grams of polygonum cuspidatum. Add 8 times and 6 times the amount of water to these 11 herbs, respectively, and boil twice, the first time for 2 hours and the second time for 1.5 hours. Filter the decoction, combine the filtrates, and concentrate by rotary evaporation to 500 ml. This extract can be directly packaged and taken orally.

[0044] Example 2:

[0045] Weigh 2 grams of raw rhubarb, 10 grams of Scutellaria baicalensis, 10 grams of Phellodendron amurense, 20 grams of Isatis tinctoria, 10 grams of Forsythia suspensa, 10 grams of Paris vietnamensis, 20 grams of Commelina communis, 6 grams of Glycyrrhiza uralensis, 4 grams of Coptis chinensis, 10 grams of Crataegus pinnatifida, and 6 grams of Polygonum cuspidatum. For these 11 herbs, add water at 8 times and 6 times the amount respectively and decoct twice. The first time is for 2 hours and the second time is for 1.5 hours. Filter the decoction, combine the filtrates, and concentrate by rotary evaporation to 500 ml to obtain. This extract can be directly packaged and taken after dissolving in water.

[0046] Example 3:

[0047] Weigh 3 grams of raw rhubarb, 15 grams of Scutellaria baicalensis, 15 grams of Phellodendron amurense, 30 grams of Isatis tinctoria, 15 grams of Forsythia suspensa, 30 grams of Paris vietnamensis, 30 grams of Commelina communis, 9 grams of Glycyrrhiza uralensis, 6 grams of Coptis chinensis, 15 grams of Crataegus pinnatifida, and 9 grams of Polygonum cuspidatum. For these 11 herbs, add water at 8 times and 6 times the amount respectively and decoct twice. The first time is for 2 hours and the second time is for 1.5 hours. Filter the decoction, combine the filtrates, and concentrate by rotary evaporation to 500 ml to obtain. This extract can be directly packaged and taken after dissolving in water.

[0048] Example 4:

[0049] Weigh 4 grams of raw rhubarb, 20 grams of Scutellaria baicalensis, 20 grams of Phellodendron amurense, 40 grams of Isatis tinctoria, 20 grams of Forsythia suspensa, 20 grams of Paris vietnamensis, 40 grams of Commelina communis, 12 grams of Glycyrrhiza uralensis, 8 grams of Coptis chinensis, 20 grams of Crataegus pinnatifida, and 12 grams of Polygonum cuspidatum. For these 11 herbs, add water at 8 times and 6 times the amount respectively and decoct twice. The first time is for 2 hours and the second time is for 1.5 hours. Filter the decoction, combine the filtrates, and concentrate by rotary evaporation to 500 ml to obtain. This extract can be directly packaged and taken after dissolving in water.

[0050] Example 5:

[0051] Weigh 5 grams of raw rhubarb, 25 grams of Scutellaria baicalensis, 25 grams of Phellodendron amurense, 50 grams of Isatis tinctoria, 25 grams of Forsythia suspensa, 25 grams of Paris vietnamensis, 50 grams of Commelina communis, 15 grams of Glycyrrhiza uralensis, 10 grams of Coptis chinensis, 25 grams of Crataegus pinnatifida, and 15 grams of Polygonum cuspidatum. For these 11 herbs, add water at 8 times and 6 times the amount respectively and decoct twice. The first time is for 2 hours and the second time is for 1.5 hours. Filter the decoction, combine the filtrates, and concentrate by rotary evaporation to 500 ml to obtain. This extract can be directly packaged and taken after dissolving in water.

[0052] Example 6: Preparation of Granules

[0053] The above eleven herbs, Rheum palmatum is pulverized into fine powder for standby use; Coptis chinensis is macerated twice with 3 times its amount of 50% ethanol for 24 hours each time, filtered, and the filtrates are combined for standby use. The remaining nine herbs including Scutellaria baicalensis are each added with 8 times and 6 times their amounts of water, decocted twice (the residue after macerating Coptis chinensis is added during the second decoction), 1 hour each time, filtered, and the filtrates are combined. The filtrate is concentrated to a relative density of 1.20 (80 °C). After cooling, 2 times its amount of 80% ethanol is added, allowed to stand for 24 hours, the supernatant is taken, the standby Coptis chinensis macerated liquid is added, the ethanol is recovered and concentrated to a relative density of 1.35 (60 °C), an appropriate amount of Rheum palmatum fine powder and dextrin are added, mixed evenly, dried, pulverized, an appropriate amount of ethanol is added for granulation, dried, and 1000 g is prepared, thus obtaining the granule preparation.

[0054] Example 7:

[0055] Experiment 1: Effects of the traditional Chinese medicine compound preparation on blood glucose, body weight, ulcer wound surface and inflammatory state of experimental rats with diabetic foot

[0056] The following traditional Chinese medicine compound preparations used are all the traditional Chinese medicine compound preparations prepared in Example 1.

[0057] Experiment 1: Effects of the traditional Chinese medicine compound preparation on blood glucose, body weight, ulcer wound surface and inflammatory state of experimental rats with diabetic foot.

[0058] 1. Experimental animals: Ordinary grade SD rats, with a body weight of about 200 g, 6 weeks old, male, housed separately in cages under clean conditions in the laboratory animal house, with free access to food and water. Supplied by Shanghai SIPPR-BK Laboratory Animal Co., Ltd., animal certificate number: SCXK (Hu) 2013-0016.

[0059] 2. Experimental method

[0060] Rat diabetic foot model 1: (1) Induction stage of diabetic model: After feeding with a high-fat and high-sugar diet (formula: 68% basal diet + 15% lard + 2% cholesterol + 15% sucrose (provider: Shanghai Slack Experimental Animal Co., Ltd.)) for 4 weeks, streptozotocin (STZ) (brand: sigma, provider: Shanghai Noble Biotechnology Co., Ltd.) at a dose of 40 mg / kg was injected intraperitoneally. Three days later, the blood glucose was measured with a tail vein blood glucose meter (brand: Johnson & Johnson) and was > 16.7 mmol / L or 16.8 mmol / L. (After the rats were injected with STZ, obvious polyphagia, polydipsia, polyuria and increased feces occurred on the second day, especially polyphagia and polyuria were the most significant. With the extension of time, the above symptoms gradually aggravated. By the third week, the diabetic model group showed listlessness, slow movement, dull and lusterless fur, emaciation, and the water intake and urine output were 5 - 6 times that of normal rats, and the food intake was 2 - 3 times that of normal rats. While the normal control group of rats had good spirits, were agile in movement, had normal defecation and urination, and their body weights continued to increase. The general conditions of the rats in each treatment group were better than those in the model group, and the symptoms of "polyphagia, polydipsia, polyuria and weight loss" varied in degree. (2) Construction of foot inflammation model: After culturing standard Staphylococcus aureus (brand: ATCC), a colony suspension with a concentration of 1×10 5 colony suspension was prepared. The rats were anesthetized, and 50 μl of the suspension was injected subcutaneously into the right hind footpad of diabetic rats. 24 hours after the model was established, the animals were given intragastric administration continuously for a one-month cycle.

[0061] The experiment of rat diabetic foot model 1 was divided into four groups: a normal group, a model group, a model + traditional Chinese medicine compound preparation group, and a model + positive drug (levofloxacin) administration group. The administration group was the traditional Chinese medicine compound preparation prepared in Example 1 of the present invention, and the drug dosage was calculated at 1.5 g / kg / day for intragastric administration. The positive control group was levofloxacin at 1.9 g / kg / day. The above drugs were administered continuously for one month, and the blood glucose and body weight were recorded weekly. One month later, the rats were sacrificed by anesthesia, blood samples were taken from the abdominal aorta, and foot samples were fixed with paraformaldehyde and stored in liquid nitrogen.

[0062] Rat diabetic foot model 2: (1) Induction stage of diabetic model: After feeding with high-fat and high-sugar diet (formula: 68% basal diet + 15% lard + 2% cholesterol + 15% sucrose (provider: Shanghai Slack Experimental Animal Co., Ltd.)) for 4 weeks, 40 mg / kg streptozotocin (STZ) (brand: sigma, provider: Shanghai Nuobao Biotechnology Co., Ltd.) was intraperitoneally injected. Three days later, the blood glucose was measured with a tail vein blood glucose meter (brand: Johnson & Johnson) > 16.7 mmol / L or 16.8 mmol / L. (After the rats were injected with STZ, obvious polyphagia, polydipsia, polyuria and increased feces appeared on the second day, especially polyphagia and polyuria were the most significant. With the extension of time, the above symptoms gradually worsened. By the third week, the diabetic model group showed listlessness, slow movement, dull and lusterless fur, emaciation, and the water intake and urine output were 5 - 6 times that of normal rats, and the food intake was 2 - 3 times that of normal rats. While the normal control group of rats had good spirits, quick movement, normal defecation and urination, and continuous weight gain. The general condition of rats in each treatment group was better than that of the model group, and the symptoms of "three more and one less" were different in degree. (2) Construction of foot ulcer model: After anesthesia, a 2 cm * 5 cm wound was constructed on the dorsal foot of diabetic rats.)

[0063] The experiment of rat diabetic foot model 2 was divided into 5 groups: normal group, model group, model plus traditional Chinese medicine compound preparation and model plus positive drug metformin administration group. The administration group was the traditional Chinese medicine compound preparation prepared in Example 1 of the present invention, and the drug dosage was calculated according to 1.5 g / kg / day for gavage, and the positive control group metformin was 500 mg / kg / day. The above drugs were continuously administered for one month, and the blood glucose and body weight were recorded every week.)

[0064] 3. Experimental results

[0065] (1) Rat diabetic foot model 1:

[0066] There was a statistically significant difference between the blood glucose of the traditional Chinese medicine compound preparation group and the model group, *P < 0.05, see Table 1 for details. It can be seen from Table 1 that the traditional Chinese medicine compound preparation has a certain blood glucose-lowering effect. The traditional Chinese medicine compound preparation has no significant effect on body weight (Table 2). Compared with the diabetic foot model group, the inflammation level in the traditional Chinese medicine compound preparation group was reduced, and the difference between the two groups was statistically significant, △P < 0.05 (Table 3). Pathological examination also showed that the traditional Chinese medicine compound preparation group could improve the pathological state of foot inflammation in diabetic foot rats (Table 4).

[0067] Table 1. Effect of traditional Chinese medicine compound preparation on rat blood glucose (mmol / l, )

[0068] Group / Days 7 14 21 28 Normal Group 8.8±0.7 8.8±0.6 8.8±0.7 8.9±0.9 Model Control Group <![CDATA[30.1±4.7 ** > <![CDATA[33.0±0.0 ** > <![CDATA[33.0±0.0 ** > <![CDATA[29.7±7.9 ** > Traditional Chinese Medicine Compound Group <![CDATA[23.7±7.1 △△ > 30.0±0.0 <![CDATA[15.6±8.2 △△ > <![CDATA[16.4±5.5 △△ > Positive Control Group 28.7±3.9 <![CDATA[28.8±6.9 △ > <![CDATA[25.3±7.4 △ > <![CDATA[27.5±7.9 △△ >

[0069] VS normal group: *P < 0.05, **P < 0.01; VS model group: △P < 0.05, △△P < 0.01. The number of animals in each group was n = 8.

[0070] Table 2. Effects of traditional Chinese medicine compound preparation on the body weight of rats (g, )

[0071] Group / Days 7 14 21 28 Normal Group 349.3±38.9 437.1±16.2 466.4±15.8 477.8±16.1 Model Control Group 315.0±11.7 334.8±31.0 <![CDATA[347.2±30.4 ** > <![CDATA[339.5±24.7 ** > Traditional Chinese Medicine Compound Group 323.0±16.0 342.2±29.7 351.2±28.1 325.2±21.5 Positive Control Group 344.0±16.9 353.1±18.6 355.1±20.1 362.5±18.4

[0072] VS normal group: *P < 0.05, **P < 0.01; VS model group: △P < 0.05, △△P < 0.01. The number of animals in each group was n = 8.

[0073] Table 3. Effects of traditional Chinese medicine compound preparation on serum inflammatory factors in rats (ug / ml, )

[0074] Group / Inflammatory Factor IL-6 TNF-a CRP Normal Group 44.6±17.1 9.0±1.8 36.2±25.2 Model Control Group <![CDATA[89.0±16.1 * > 10.3±1.0 <![CDATA[97.1±1.5 * > Traditional Chinese Medicine Compound Group <![CDATA[26.3±2.9 △△ > <![CDATA[5.1±0.5 △△ > <![CDATA[52.4±3.0 △ > Positive Control Group <![CDATA[23.8±14.9 △△ > <![CDATA[5.5±1.2 △△ > <![CDATA[163.6±15.5 △△ >

[0075] VS normal group: *P < 0.05, **P < 0.01; VS model group: △P < 0.05, △△P < 0.01. The number of animals in each group was n = 8.

[0076] Table 4. Effects of traditional Chinese medicine compound on foot inflammation in rats

[0077] Group Normal Group Model Group Traditional Chinese Medicine Compound Group Positive Control Group Degree of Inflammatory Cell Infiltration 1.2±0.32 2.52±0.16 2.14±0.71 1.69±0.19 Integrity of Tissue Structure <![CDATA[1.80±0.10 △ > <![CDATA[2.33±0.15 △ > 1.97±0.42 1.86±0.21

[0078] VS normal group: *P < 0.05, **P < 0.01; VS model group: △P < 0.05, △△P < 0.01. The number of animals in each group was n = 5.

[0079] Rat diabetic foot model 2: (1) Induction stage of diabetic model: After feeding with a high-fat and high-sugar diet (formula: 68% basal diet + 15% lard + 2% cholesterol + 15% sucrose (provider: Shanghai Slack Experimental Animal Co., Ltd.)) for 4 weeks, 40 mg / kg streptozotocin (STZ) (brand: sigma, provider: Shanghai Nuobao Biotechnology Co., Ltd.) was injected intraperitoneally. Three days later, a blood glucose meter (brand: Johnson & Johnson) was used to measure the blood glucose in the tail vein, and the blood glucose was > 16.7 mmol / L or 16.8 mmol / L. (After the rats were injected with STZ, obvious polyphagia, polydipsia, polyuria and increased feces occurred on the second day, especially polyphagia and polyuria were the most significant. With the extension of time, the above symptoms gradually worsened. By the third week, the diabetic model group showed listlessness, slow movement, dull and lusterless fur, emaciation, and the water intake and urine output were 5 - 6 times that of normal rats, and the food intake was 2 - 3 times that of normal rats. While the normal control group of rats had good spirits, quick movements, normal defecation and urination, and their body weights continued to increase. The general conditions of the rats in each treatment group were better than those in the model group, and the symptoms of "polyphagia, polydipsia, polyuria and weight loss" varied in degree. (2) Construction of foot ulcer model: After anesthesia, a 2 cm * 5 cm wound was constructed on the dorsal foot of the diabetic rats.)

[0080] The experiment of rat diabetic foot model 2 was divided into 5 groups: normal group, model group, model plus traditional Chinese medicine compound preparation, and model plus positive drug metformin administration group. The administration group was the traditional Chinese medicine compound preparation prepared in Example 1 of the present invention, and the drug dosage was calculated at 1.5 g / kg / day for gavage. The positive control group of metformin was 500 mg / kg / day. The above drugs were administered continuously for one month, and the body weight (Table 5) and blood glucose (Table 6) were recorded weekly. It was observed from the body weight detection in Table 5 that compared with the model group, after continuously administering the traditional Chinese medicine compound preparation prepared in Example 1 of the present invention for 28 days, the body weight of the rats could be increased. It was observed from the blood glucose detection in Table 6 that compared with the model group, the blood glucose of the traditional Chinese medicine compound preparation was significantly reduced on the 14th day, 21st day and 28th day compared with the model group.)

[0081] Table 5. Effect of traditional Chinese medicine compound preparation on rat body weight (g, )

[0082] Group / Days 7 14 21 28 Normal Group 323.17±19.35 343.36±33.45 341.4±29.83 347.9±36.78 Model Control Group 328.94±13.22 303.87±32.17 310.0±8.99 323.0±15.94 Traditional Chinese Medicine Compound Group 330.89±10.51 321.34±32.65 347.2±47.36 <![CDATA[373.5±41.77 △ > Positive Control Group 323.13±15.34 330.75±33.57 348.6±40.63 350.4±48.78

[0083] VS normal group: *P < 0.05, **P < 0.01; VS model group: △P < 0.05, △△P < 0.01. The number of animals in each group n = 8.)

[0084] Table 6. Effect of traditional Chinese medicine compound preparation on rat blood glucose (mmol / l, )

[0085] Group / Days 7 14 21 28 Normal Group 9.82±0.29 8.67±1.01 9.71±0.31 9.7±0.31 Model Control Group <![CDATA[31.11±0.82 ** > <![CDATA[27.13±2.65 ** > <![CDATA[28.73±3.08 ** > <![CDATA[21.60±3.61 ** > Traditional Chinese Medicine Compound Group 28.55±1.447 <![CDATA[12.74±2.06 △△ > <![CDATA[13.72±3.12 △△ > 14.3±2.31 Positive Control Group 27.96±1.480 26.33±2.36 <![CDATA[12.08±6.61 △△ > 14.12±8.23

[0086] VS normal group: *P < 0.05, **P < 0.01; VS model group: △P < 0.05, △△P < 0.01. The number of animals in each group was n = 8.

[0087] Experiment 2. Effects of the traditional Chinese medicine compound preparation on blood glucose, body weight, ulcer wound surface and inflammatory state of diabetic foot experimental mice.

[0088] The traditional Chinese medicine compound preparation used below is the traditional Chinese medicine compound preparation prepared in Example 1.

[0089] 1. Experimental animals: Ordinary-grade C57 mice, 4 - 6 weeks old, weighing 18 - 20 g, male, caged and raised under clean conditions in the laboratory animal house, with free access to food and water. Provided by Hangzhou Medical College, animal certificate number: SCXK(Shanghai)2019 - 0002.

[0090] 2. Experimental methods

[0091] Mouse diabetic foot model: 1) Diabetes model induction stage: After feeding with high-fat and high-sugar diet for 5 weeks, fast the mice for 12 h before modeling, with free access to water. Dissolve STZ at a dose of 50 mg / kg per day in 0.1 mmol / L citric acid buffer solution (pH = 4.2), and inject the mice intraperitoneally once a day for 5 consecutive days on an empty stomach for 6 h. Mice with a measured blood glucose value greater than 11.1 mmol / L are considered successfully modeled mice. (After the mice were injected with STZ, obvious polyphagia, polydipsia, polyuria and increased feces occurred, especially polyphagia and polyuria were the most significant. As time went by, the above symptoms gradually worsened. By the third week, the diabetic model group showed listlessness, slow movement, dull and lackluster fur, emaciation, and the drinking and urine output were 5 - 6 times that of normal mice, and the food intake was 2 - 3 times that of normal rats. While the normal control group of mice were in good spirits, quick in movement, with normal defecation and urination, and their body weight continued to increase. The general condition of mice in each treatment group was better than that of the model group, and the symptoms of "polyphagia, polydipsia, polyuria and weight loss" varied in degree. (2) Construction of ulcer wound surface model: After anesthetizing the diabetic mice, construct a 3 cm * 3 cm wound on their backs.

[0092] The mouse diabetic foot model experiment was divided into 5 groups: normal group, model group, model plus traditional Chinese medicine compound preparation and model plus positive drugs (metformin and epidermal growth factor) administration groups. The administration group was the traditional Chinese medicine compound preparation prepared in Example 1 of the present invention, and the drug dosage was calculated at 2.7 g / kg / day for gavage. The positive control group was given metformin by gavage at 0.2 g / kg / day and epidermal growth factor was topically administered at 100 U / cm2. The above drugs were continuously administered for 2 weeks, and blood glucose, body weight and wound surface photos were recorded every week. After 2 weeks, the mice were sacrificed by anesthesia, blood was taken from the eyeballs, the ulcer samples of the wound surface were fixed with paraformaldehyde and stored in liquid nitrogen.

[0093] 3. Experimental results

[0094] There was no statistically significant difference in blood glucose between the traditional Chinese medicine compound preparation group and the model group, *P < 0.05. See Table 7 for details. Compared with the diabetic foot model group, the wound healing in the traditional Chinese medicine compound preparation group was better, and the difference between the two groups was statistically significant, *P < 0.05 (Tables 8 and 9). Pathological examinations also showed that the traditional Chinese medicine compound preparation group could improve the inflammatory pathological state of the ulcer wound surface in diabetic foot mice and promote collagen deposition (Tables 10, 11, and 12). The traditional Chinese medicine compound preparation group could improve the levels of the inflammatory secretion factor IL-17A and the inflammatory transcription factor RORγt in diabetic foot mice (Tables 13 and 14).

[0095] Table 7. Effects of traditional Chinese medicine compound preparation on blood glucose in diabetic ulcer mice (mmol / l, )

[0096] Days / Group Normal Group Acute Injury Group Model Group Traditional Chinese Medicine Compound Group Positive Drug 1 Positive Drug 2 0 9.81±0.68 9.57±2.23 32.7±2.29 33.3±0 33.3±0 33.3±0 7 9.76±0.80 10.28±1.26 <![CDATA[32.6±1.83 * > 32.8±1.20 32.5±1.69 33.3±0 14 9.87±0.54 10.72±1.04 <![CDATA[29.8±2.64 * > 29.7±3.06 <![CDATA[23.3±1.56 △ > 30.8±3.13

[0097] VS normal group: *P < 0.05, **P < 0.01; VS model group: △P < 0.05, △△P < 0.01. The number of animals in each group was n = 5.

[0098] Table 8. Effects of traditional Chinese medicine compound on wound area of diabetic ulcer mice compared with day 0

[0099] Days / Group Acute Injury Group Model Group Traditional Chinese Medicine Compound Group Positive Drug 1 Positive Drug 2 7 0.25±0.03 0.69±0.07** <![CDATA[0.48±0.05 △ > 0.71±0.04 <![CDATA[0.47±0.06 △ > 14 0.02±0.01 0.13±0.02** 0.10±0.02 <![CDATA[0.37±0.07 △ > 0.12±0.03

[0100] VS normal group: *P < 0.05, **P < 0.01; VS model group: △P < 0.05, △△P < 0.01. The number of animals in each group was n = 5.

[0101] Table 9. Effects of traditional Chinese medicine compound on wound healing degree of diabetic ulcer mice (% )

[0102] Days / Group Acute Injury Group Model Group Traditional Chinese Medicine Compound Group Positive Drug 1 Positive Drug 2 7 0.79±0.05 0.49±0.12 0.58±0.1 0.35±0.01 0.58±0.13 14 0.93±0.02 0.83±0.01 0.88±0.05 0.73±0.07 0.85±0.05

[0103] VS normal group: *P < 0.05, **P < 0.01; VS model group: △P < 0.05, △△P < 0.01. The number of animals in each group was n = 5.

[0104] Table 10. Pathological scoring criteria

[0105]

[0106] VS normal group: *P < 0.05, **P < 0.01; VS model group: △P < 0.05, △△P < 0.01.

[0107] Table 11. Effects of traditional Chinese medicine compound on wound pathology of diabetic ulcer mice

[0108] Days / Group Acute Injury Group Model Group Traditional Chinese Medicine Compound Group Positive Drug 1 Positive Drug 2 7 2.23±0.15 2.27±0.15 <![CDATA[1.80±0.10 △ > 1.83±0.25 <![CDATA[1.83±0.15 △ > 14 1.50±0.10 1.90±0.10 <![CDATA[1.53±0.15 △ > 1.60±0.20 <![CDATA[1.57±0.15 △ >

[0109] VS normal group: *P < 0.05, **P < 0.01; VS model group: △P < 0.05, △△P < 0.01. The number of animals in each group was n = 5.

[0110] Table 12. Effect of traditional Chinese medicine compound on collagen in diabetic ulcer mice

[0111] Days / Group Acute Injury Group Model Group Traditional Chinese Medicine Compound Group Positive Drug 1 Positive Drug 2 7 7.25±0.826 8.2±0.7 8.2±1.72 7.78±1.03 6.2±1.62 14 4.31±0.808 2.98±1.52 <![CDATA[4.68±0.97 △ > 4.23±0.16 <![CDATA[4.65±1.06 △ >

[0112] VS normal group: *P < 0.05, **P < 0.01; VS model group: △P < 0.05, △△P < 0.01. The number of animals in each group was n = 5.

[0113] Table 13. Effect of traditional Chinese medicine compound on inflammatory factor IL17A in diabetic ulcer mice

[0114] Days / Group Normal Group Acute Injury Group Model Group Traditional Chinese Medicine Compound Group Positive Drug 1 Positive Drug 2 7 0.41±0.29 <![CDATA[2.93±0.61 ** > <![CDATA[0.96±0.02 * > <![CDATA[0.49±0.25 △ > 1.63±0.77 0.57±0.27 14 0.69±0.34 <![CDATA[1.79±0.62 * > <![CDATA[1.79±0.48 ** > <![CDATA[0.83±0.32 △ > <![CDATA[1.37±0.42 △ > <![CDATA[0.69±0.39 △ >

[0115] VS normal group: *P < 0.05, **P < 0.01; VS model group: △P < 0.05, △△P < 0.01. The number of animals in each group was n = 5

[0116] Table 14. Effect of traditional Chinese medicine compound on inflammatory transcription factor RORgamaT in diabetic ulcer mice

[0117] Days / Group Normal Group Acute Injury Group Model Group Traditional Chinese Medicine Group Positive Drug 1 Positive Drug 2 7 2.55±0.61 2.44±0.81 <![CDATA[4.52±0.79 * > <![CDATA[2.01±0.83 △ > 3.25±0.98 2.07±0.37 14 0.55±0.16 <![CDATA[1.41±0.11 ** > <![CDATA[1.29±0.37 * > <![CDATA[0.56±0.17 △ > <![CDATA[0.79±0.36 △ > 0.74±0.25

[0118] VS normal group: *P < 0.05, **P < 0.01; VS model group: △P < 0.05, △△P < 0.01. The number of animals in each group was n = 5

[0119] The above are only the preferred embodiments of the present invention, and do not impose any form of limitation on the present invention. Although the present invention has been disclosed as above with the preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art of this patent, without departing from the scope of the technical solution of the present invention, may make some changes or modifications using the technical content prompted above as equivalent embodiments of equivalent changes. However, any simple modification, equivalent change and modification made to the above embodiments based on the technical essence of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition for treating diabetic foot, characterized in that, It is made from the following components in parts by weight: 1 - 5 parts of Rheum officinale, 5 - 25 parts of Scutellaria baicalensis, 5 - 25 parts of Phellodendron amurense, 10 - 50 parts of Isatis tinctoria, 5 - 25 parts of Forsythia suspensa, 5 - 30 parts of Paris vietnamensis, 10 - 50 parts of Commelina communis, 3 - 15 parts of Glycyrrhiza uralensis, 2 - 10 parts of Coptis chinensis, 5 - 25 parts of Crataegus pinnatifida, 3 - 15 parts of Polygonum cuspidatum.

2. The traditional Chinese medicine composition for treating diabetic foot according to claim 1, wherein, It is made from the following components in parts by weight: 1 part of Rheum officinale, 5 parts of Scutellaria baicalensis, 5 parts of Phellodendron amurense, 10 parts of Isatis tinctoria, 5 parts of Forsythia suspensa, 5 parts of Paris vietnamensis, 10 parts of Commelina communis, 3 parts of Glycyrrhiza uralensis, 2 parts of Coptis chinensis, 5 parts of Crataegus pinnatifida, 3 parts of Polygonum cuspidatum.

3. The traditional Chinese medicine composition for treating diabetic foot according to claim 1, wherein, It is made from the following components in parts by weight: 2 parts of Rheum officinale, 10 parts of Scutellaria baicalensis, 10 parts of Phellodendron amurense, 20 parts of Isatis tinctoria, 10 parts of Forsythia suspensa, 10 parts of Paris vietnamensis, 20 parts of Commelina communis, 6 parts of Glycyrrhiza uralensis, 4 parts of Coptis chinensis, 10 parts of Crataegus pinnatifida, 6 parts of Polygonum cuspidatum.

4. The traditional Chinese medicine composition for treating diabetic foot according to claim 1, wherein, It is made from the following components in parts by weight: 3 parts of Rheum officinale, 15 parts of Scutellaria baicalensis, 15 parts of Phellodendron amurense, 30 parts of Isatis tinctoria, 15 parts of Forsythia suspensa, 30 parts of Paris vietnamensis, 30 parts of Commelina communis, 9 parts of Glycyrrhiza uralensis, 6 parts of Coptis chinensis, 15 parts of Crataegus pinnatifida, 9 parts of Polygonum cuspidatum.

5. The traditional Chinese medicine composition for treating diabetic foot according to claim 1, characterized in that, It is made from the following components in parts by weight: 4 parts of Rheum officinale, 20 parts of Scutellaria baicalensis, 20 parts of Phellodendron amurense, 40 parts of Isatis tinctoria, 20 parts of Forsythia suspensa, 20 parts of Paris vietnamensis, 40 parts of Commelina communis, 12 parts of Glycyrrhiza uralensis, 8 parts of Coptis chinensis, 20 parts of Crataegus pinnatifida, 12 parts of Polygonum cuspidatum.

6. The traditional Chinese medicine composition for treating diabetic foot according to claim 1, wherein It is made from the following components in parts by weight: 5 parts of Rheum officinale, 25 parts of Scutellaria baicalensis, 25 parts of Phellodendron amurense, 50 parts of Isatis tinctoria, 25 parts of Forsythia suspensa, 25 parts of Paris vietnamensis, 50 parts of Commelina communis, 15 parts of Glycyrrhiza uralensis, 10 parts of Coptis chinensis, 25 parts of Crataegus pinnatifida, 15 parts of Polygonum cuspidatum.

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

8. The application according to claim 7, wherein The medicament is for treating diabetic foot of the syndrome type of damp - heat toxin excess mainly characterized by dampness - resolving and inflammation - relieving.

9. A pharmaceutical preparation for treating diabetic foot, characterized in that, It is made from the traditional Chinese medicine composition according to any one of claims 1 - 6.

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