Traditional Chinese medicine composition for treating wind-cold-dampness retention type rheumatoid arthritis and application of traditional Chinese medicine composition

Abstract

The invention relates to a traditional Chinese medicine composition for treating wind-cold-dampness obstruction type rheumatoid arthritis and application thereof. The traditional Chinese medicine composition comprises the following components in parts by weight: 13-17 parts of astragalus membranaceus, 7-11 parts of codonopsis pilosula, 7-11 parts of cassia twig, 2-4 parts of radix aconiti preparata, 4-8 parts of ephedra, 7-11 parts of salvia miltiorrhiza, 7-11 parts of achyranthes bidentata and 7-11 parts of honey-fried licorice root. Compared with the prior art, the traditional Chinese medicine composition disclosed by the invention is convenient to take, exact in curative effect and simple in compatibility, has the effective rate of 84.8% in treatment of wind-cold-dampness obstruction type rheumatoid arthritis, does not have obvious toxic or side effects, and has the advantages of safe medication, moderate treatment course, low recurrence rate and the like.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for treating rheumatoid arthritis of the wind-cold-dampness type and its application. Background Technology

[0002] Rheumatoid arthritis of the wind-cold-dampness type, known as "Wangbi" in Traditional Chinese Medicine (TCM), falls under the categories of "Bi syndrome" and "Lijie." It is a common chronic autoimmune disease characterized by joint swelling, stiffness, deformity, limited flexion and extension, and bone damage. Western medicine believes that the disease is mainly related to immune tolerance imbalance, leading to synovitis and cartilage and bone destruction. Its pathogenesis is closely related to genetic, environmental, and immune factors. Clinically, it commonly presents as symmetrical small joint arthritis, frequently affecting the hands, wrists, and knees, accompanied by systemic symptoms such as morning stiffness, fatigue, low-grade fever, and anemia. If the disease progresses, it can lead to joint deformities and loss of function, severely impacting quality of life. Epidemiological surveys show a global incidence rate of approximately 0.5%–1%, with significantly more women than men, and a peak age of onset between 30 and 50 years.

[0003] Traditional Chinese medicine believes that the core pathogenesis of this disease is "deficiency of the root and excess of the branch." The "root" lies in the deficiency of the liver, spleen, and kidneys, leading to insufficient nutritive qi and blood; the "branch" lies in the invasion of wind, cold, and dampness, and the mutual binding of phlegm and blood stasis in the collaterals. The *Suwen* (Plain Questions) chapter on Bi syndrome states, "When wind, cold, and dampness combine, they cause Bi syndrome," clearly indicating the conditions for external pathogens to cause disease. However, the underlying cause of the invasion of external pathogens lies in the "disharmony of nutritive qi and blood." As stated in "Ling Shu: Zhou Bi", "wind, cold and dampness invade the muscles and skin... causing pain when they split", revealing the pathogenesis of pathogenic factors invading the skin and obstructing the flow of qi and blood. In "Lei Zheng Zhi Cai" in the Qing Dynasty, Lin Peiqin further clarified: "All kinds of bi syndromes... are caused by the deficiency of ying and wei qi, and the loosening of the pores, allowing wind, cold and dampness to invade from within... causing qi and blood to stagnate and become bi syndrome over time". This profoundly reveals that "deficiency of ying and wei qi" is the internal cause of the disease, while the invasion of wind, cold and dampness is the external cause. The two work together to cause qi and blood to stagnate and become bi syndrome.

[0004] The *Huangdi Neijing* (Yellow Emperor's Inner Classic) states that "the imbalance of *ying* and *wei* qi causes *bi* (a type of arthralgia)," laying the theoretical foundation for later generations' understanding of *bi* from the perspective of *ying* and *wei*. *Ying* qi circulates within the vessels, governing nourishment and metabolism; *wei* qi circulates outside the vessels, governing defense and regulation. Like day and night, they cycle in harmony, mutually supporting each other, maintaining smooth blood flow and homeostasis. If *ying* and *wei* are out of balance, *ying* circulation becomes disordered, *wei* weakens, fluid circulation is impaired, blood flow is sluggish, and immune regulation is disrupted. Modern research suggests that *ying* qi corresponds to the nutritional and metabolic layer of blood circulation, while *wei* qi corresponds to the immune defense and regulatory layer. Harmony between *ying* and *wei* leads to smooth blood flow and immune balance; disharmony results in microcirculatory disturbances, increased release of inflammatory factors, synovial congestion and edema, ultimately causing joint inflammation and bone destruction.

[0005] Based on the TCM theories of "wind, cold, and dampness causing arthritis" and "nutritive and defensive qi," the pathological evolution of wind-cold-dampness obstruction type rheumatoid arthritis can be summarized into three stages. Initial stage: Disharmony between nutritive and defensive qi, weakened skin barrier, invasion of the meridians by wind, cold, and dampness, obstruction of qi and blood circulation, symptoms include joint pain and difficulty in flexion and extension; Progression stage: Retention of pathogenic factors, phlegm condensation, blood stasis, and the mutual binding of phlegm and blood stasis, penetrating deep into the muscles and bones, leading to joint swelling, stiffness, and deformity; Late stage: Prolonged arthritis depletes yang qi, damages the liver and kidneys, and the muscles and bones lose their nourishment, resulting in joint deformity, destruction, and loss of function. In this process, phlegm and blood stasis are both pathological products and key factors aggravating the obstruction, forming a vicious cycle. Treatment in TCM emphasizes both strengthening the body's resistance and eliminating pathogenic factors, commonly using methods such as dispelling wind and cold, promoting qi and blood circulation, harmonizing nutritive and defensive qi, and tonifying the liver and kidneys to relieve pain and prevent deformity.

[0006] CN109758501A discloses a traditional Chinese medicine composition for treating rheumatoid arthritis, its preparation method, and its application. The composition is made from 22 medicinal materials, including processed Aconitum carmichaelii, processed Aconitum kusnezoffii, Cinnamomum cassia, Saposhnikovia divaricata, Asarum sieboldii, Atractylodes lancea, Angelica pubescens, Stephania tetrandra, Morus alba, Spatholobus suberectus, Sargentodoxa cuneata, Piper kadsura, Angelica sinensis, processed Boswellia carterii, processed Commiphora myrrha, Codonopsis pilosula, Astragalus membranaceus, Achyranthes bidentata, Dipsacus asper, Aucklandia lappa, Magnolia officinalis, and Glycyrrhiza uralensis, in a specific ratio. The effective components are extracted by decoction, and the extract is mixed with fine powder to form pills.

[0007] CN104367911A discloses a traditional Chinese medicine composition for treating rheumatism and rheumatoid arthritis and its preparation method. The composition is made by combining 25 medicinal materials, including Codonopsis pilosula, processed Aconitum carmichaelii, processed Aconitum kusnezoffii, Polygonum multiflorum, Chaenomeles speciosa, Achyranthes bidentata, Clematis chinensis, Aconitum carmichaelii, Cinnamomum cassia, Ephedra sinica, Schizonepeta tenuifolia, Saposhnikovia divaricata, Notopterygium incisum, Gastrodia elata, Carthamus tinctorius, Eucommia ulmoides, Acanthopanax senticosus, Asarum heterotropoides, Atractylodes lancea, Angelica sinensis, Ligusticum chuanxiong, Aucklandia lappa, Alpinia galanga, Syzygium aromaticum, and Citrus reticulata, in a specific ratio to prepare a medicinal wine.

[0008] However, many existing traditional Chinese medicine formulas for treating rheumatoid arthritis are complex formulas with more than 20 ingredients, which have problems such as numerous raw materials, unreasonable compatibility (failing to accurately coordinate the relationship between the imbalance of Ying and Wei and the obstruction of pathogenic factors), and complex preparation processes (such as needing to be made into pills or medicinal wine). In addition, the efficacy is not long-lasting, which leads to limitations in immune regulation, prevention of bone erosion, joint protection and prevention of recurrence. The clinical efficacy needs to be further improved.

[0009] Therefore, improving and innovating traditional Chinese medicine treatment plans for rheumatoid arthritis of the wind-cold-dampness type, and developing new traditional Chinese medicine compound formulas, are of great practical significance and clinical value for the treatment of rheumatoid arthritis of the wind-cold-dampness type. Summary of the Invention

[0010] The purpose of this invention is to overcome at least one of the shortcomings of the existing technology, such as numerous raw materials, unreasonable compatibility, complex preparation process, and still need to be improved in clinical efficacy, and to provide a traditional Chinese medicine composition for treating rheumatoid arthritis of the wind-cold-dampness type and its application.

[0011] The object of the present application can be achieved by the following technical solutions. The present application first provides a traditional Chinese medicine composition for treating rheumatoid arthritis of wind-cold-dampness obstruction type, which specifically comprises the following components in parts by weight: 13-17 parts of Radix Astragali, 7-11 parts of Radix Codonopsis, 7-11 parts of Ramulus Cinnamomi, 2-4 parts of Radix et Rhizoma Aconiti Preparata, 4-8 parts of Ephedra, 7-11 parts of Radix Salviae Miltiorrhizae, 7-11 parts of Radix Hedysari, and 7-11 parts of Radix Glycyrrhizae.

[0012] Further, the traditional Chinese medicine composition specifically comprises the following components in parts by weight: 14-16 parts of Radix Astragali, 8-10 parts of Radix Codonopsis, 8-10 parts of Ramulus Cinnamomi, 2-4 parts of Radix et Rhizoma Aconiti Preparata, 5-7 parts of Ephedra, 8-10 parts of Radix Salviae Miltiorrhizae, 8-10 parts of Radix Hedysari, and 8-10 parts of Radix Glycyrrhizae.

[0013] Further, the traditional Chinese medicine composition specifically comprises the following components in parts by weight: 15 parts of Radix Astragali, 9 parts of Radix Codonopsis, 9 parts of Ramulus Cinnamomi, 3 parts of Radix et Rhizoma Aconiti Preparata, 6 parts of Ephedra, 9 parts of Radix Salviae Miltiorrhizae, 9 parts of Radix Hedysari, and 9 parts of Radix Glycyrrhizae.

[0014] The present application also provides an application of the traditional Chinese medicine composition in the preparation of a medicine for treating rheumatoid arthritis of wind-cold-dampness obstruction type, wherein the medicine is an oral preparation, which includes any one of water decoction, granules, lyophilized powder, tablets, capsules, pills, oral liquid, or syrup.

[0015] Further, the medicine further includes a pharmaceutically acceptable excipient.

[0016] Further, the preparation method of the water decoction is as follows: S1: Prepare the medicinal materials, wash and dry them for standby use; S2: Put Radix et Rhizoma Aconiti Preparata in a container and soak it in cold water, and put the remaining medicinal materials in another container and soak them in cold water; S3: Perform first decocting treatment on Radix et Rhizoma Aconiti Preparata; S4: After the first decocting treatment of Radix et Rhizoma Aconiti Preparata, add the remaining medicinal materials to perform the first decocting, and filter to obtain the first decocting liquid; S5: Add clean water to perform the second decocting, and filter to obtain the second decocting liquid; S6: Combine the two decocting liquids and stir them evenly for standby use.

[0017] Further, in step S2, Radix et Rhizoma Aconiti Preparata is soaked in 150-250 mL of cold water for 20-40 min; and the remaining medicinal materials are soaked in 500-700 mL of cold water for 20-40 min.

[0018] Further, in step S3, the first decocting treatment is performed for 20-40 min.

[0019] Further, in step S4, the first decoction is boiled with a strong fire and then with a weak fire for 20-40 minutes to obtain 200-300 mL of the first decoction.

[0020] Further, in step S5, 500-700 mL of water is added to the residue of the first decoction, which is boiled with a strong fire and then with a weak fire for 20-40 minutes to obtain 200-300 mL of the second decoction.

[0021] Further, one dose of the decoction is taken per day, twice a day.

[0022] In the traditional Chinese medicine composition of the present application, wherein: (1) Huangqi: sweet, slightly warm, and enters the spleen and lung meridians. It has the effects of tonifying qi and ascending yang, consolidating the exterior and stopping sweating, promoting water metabolism and reducing swelling, generating saliva and nourishing blood, removing stagnation and relieving arthralgia, promoting pus discharge and promoting wound healing and muscle regeneration. It is commonly used to treat qi deficiency, poor appetite and loose stools, middle qi collapse, chronic diarrhea, prolapse of the rectum, hematochezia, metrorrhagia, self-sweating due to deficiency of the exterior, qi deficiency edema, internal heat and polydipsia, blood deficiency and emaciation, hemiplegia, arthralgia and numbness, and chronic ulceration and non-healing of chronic ulcers.

[0023] Modern pharmacological studies have shown that Huangqi contains polysaccharides (such as Huangqi polysaccharide), flavonoids (such as calycosin, formononetin), saponins (such as Astragalus saponin), and amino acids, trace elements and other active ingredients. These components play an important role in anti-inflammatory, antioxidant, immune regulation and improvement of cardiovascular function. 1. Its anti-inflammatory effect is mainly through the inhibition of NF-κB, TLR4 / MyD88 signaling pathway, and the reduction of the expression of TNF-α, IL-1β, COX-2 and other inflammatory mediators, thereby reducing inflammation and joint synovial membrane damage. 2. Its antioxidant activity is reflected in the flavonoids' ability to scavenge free radicals, increase superoxide dismutase activity, and reduce malondialdehyde levels. Astragalus saponin can also reduce oxidative stress through MAPK, PI3K / Akt, Nrf2 / ARE signaling pathways, and delay joint destruction. 3. Its immune regulation includes promoting the maturation of dendritic cells and the phagocytic function of macrophages, enhancing the secretion of IL-6, IL-12 and other cytokines, and regulating Th1 / Th2 and Treg / Th17 immune balance, thereby improving immune abnormalities in the body. 4. Huangqi saponin and other components can also dilate blood vessels, improve heart function, and promote blood circulation, and have a protective effect on microcirculation disorders related to chronic inflammatory diseases such as rheumatoid arthritis.

[0024] (2) Dangshen: sweet, flat, and enters the spleen and lung meridians. It has the effects of tonifying the spleen and lung, nourishing blood and generating saliva. It is commonly used to treat spleen and lung deficiency, poor appetite and fatigue, cough and shortness of breath, blood deficiency, pale complexion, palpitation and shortness of breath, and dry mouth and thirst due to internal heat and polydipsia.

[0025] Modern pharmacological studies show that Radix Codonopsis contains a variety of active ingredients, and 34 main compounds are identified by UPLC-Q-TOF-MS, including flavonoids (such as apigenin, tricin, luteolin glycoside, astragalus glycoside), phenylpropanoids (such as chlorogenic acid, aesculin, ferulic acid, caffeic acid), triterpenes (such as oleanolic acid), organic acids (such as citric acid) and some esters and polyacetylenes. Among them, apigenin, chlorogenic acid, ferulic acid, caffeic acid, oleanolic acid and others are considered to be the main active ingredients. 1. Animal experiments have confirmed that Radix Codonopsis extract can significantly increase the body weight of collagen-induced arthritis rats, reduce the toe swelling degree and arthritis index, reduce synovial tissue inflammatory cell infiltration and pathological hyperplasia, and reduce the levels of TNF-α, IL-1β and IL-6 in serum, suggesting that it has good anti-inflammatory effect. 2. Further mechanism studies show that Radix Codonopsis can down-regulate the protein expression of TLR2, TLR4, NF-κBp65 and p-p38MAPK / p38MAPK, inhibit the excessive activation of TLRs / MAPKs / NF-κB signaling pathway, and thus reduce the inflammation and tissue destruction of arthritis. 3. Radix Codonopsis can also reduce the thymus and spleen index, suggesting that it has certain immunoregulatory effect. Compared with methotrexate, a commonly used anti-rheumatic drug, Radix Codonopsis has slightly weaker efficacy, but has less side effects and is suitable for long-term use, showing potential development value as a natural anti-rheumatic drug.

[0026] (3) Cassia twig: pungent, sweet, warm. Belongs to heart, lung and bladder meridians. It has the effects of sweating and relieving the skin, warming the meridians, assisting Yang and transforming Qi, and reducing Qi, etc. It is often used to treat colds, cold abdominal pain, blood cold amenorrhea, joint pain, phlegm, edema, palpitation, and other diseases.

[0027] Modern pharmacological studies show that cassia twig contains amino acids, flavonoids, saponins and alkaloids, etc. Among them, cinnamyl aldehyde is one of the main effective components. 1. Cinnamyl aldehyde can block the PI3K / AKT pathway, reduce the expression of TNF-α, IL-1β and IL-6 in rheumatoid arthritis synovial fibroblasts (RA-FLS), inhibit the level of anti-apoptotic protein Bcl-2, and promote the expression of Bax, caspase-3 and caspase-9, thereby inducing RA-FLS apoptosis and reducing inflammation. 3. The trans-isomer of cinnamyl aldehyde, trans-cinnamyl aldehyde, can also reduce the expression of TNF-α, IL-1β, IL-6, IL-23 and IL-17 and other inflammatory factors by inhibiting the NF-κB signaling pathway, thereby playing a regulatory role in immune inflammation and improving arthritis symptoms.

[0028] (4) Prepared aconite: pungent, bitter, hot, toxic. Belongs to heart, liver, kidney and spleen meridians. It has the functions of dispelling wind and dampness, warming the channels and relieving pain. It is often used to treat rheumatism, joint pain, cold abdominal pain, cold pain, and other diseases.

[0029] Modern pharmacological studies show that the main chemical components of Chuanwu are diterpene alkaloids (such as aconitine, mesaconitine, hypaconitine, benzoylaconine, and aconine), as well as a small amount of flavonoids, saponins, and polysaccharides. Double-ester diterpene alkaloids are not only the main effective components of Chuanwu, but also the main toxic components. After processing, they are mostly converted into monoglyceride and alcohol amine type alkaloids with weaker toxicity, thereby achieving the purpose of reducing toxicity while retaining efficacy. 1. Chuanwu has significant anti-inflammatory and analgesic effects. It can inhibit the secretion of inflammatory factors such as PGE2, TNF-α, IL-1β, and IL-6, inhibit the activation of signaling pathways such as NF-κB, MAPK, and Akt, and exert anti-rheumatic and anti-inflammatory effects. It also shows good inhibitory effect on animal models of carrageenan-induced inflammation and adjuvant arthritis. 2. The analgesic effect of Chuanwu involves the central nervous system. It can reduce chronic inflammatory pain, neuropathic pain, and cancer pain by promoting the release of dynorphin A in the spinal cord, activating κ-opioid receptors, and inhibiting TRPV1 ion channels, and it is not prone to develop tolerance. 3. Chuanwu also shows cardiovascular protection. For example, hypaconitine can inhibit the apoptosis of endothelial cells induced by oxidized low-density lipoprotein, and aconitine can reduce myocardial hypertrophy by inhibiting the expression of myocardial hypertrophy factors induced by Ang II, thus having a certain protective effect on the cardiovascular system. 4. Chuanwu also shows certain pharmacological potential in systemic lupus erythematosus, cerebral infarction, and mitochondrial-related diseases, such as improving immune function, regulating fibrinolytic system, and activating AMPK pathway.

[0030] (5) Ephedra: pungent, slightly bitter, warm. It belongs to the lung and bladder meridians. It has the functions of sweating and dispelling cold, promoting the lung and relieving asthma, and promoting water and reducing swelling. It is commonly used to treat wind-cold syndrome, chest tightness, cough, and edema.

[0031] Modern pharmacological studies have shown that the main active ingredient of Ephedra, ephedrine (EPH), plays an important role in the prevention and treatment of rheumatoid arthritis, and its molecular mechanism is closely related to the polarization of macrophages and the regulation of inflammatory signaling pathways. 1. In vitro experiments show that EPH can inhibit the abnormal proliferation and invasion of human rheumatoid arthritis synovial fibroblasts (MH7A) induced by TNF-α, and promote cell apoptosis, while significantly reducing TLR8 protein expression. 2. The results of macrophage conditioned medium experiments show that M1 type macrophages can enhance the proliferation and invasion of MH7A cells and reduce their apoptosis rate, while EPH intervention can inhibit M1 type polarization by reducing iNOS and increasing Arg-1 levels, and reverse its adverse effects on MH7A cells. 3. Further mechanism studies have found that EPH can inhibit the TLR8-MyD88-TRAF6 signaling axis, block the polarization-related pathway of M1 type macrophages, and thus reduce the secretion of inflammatory factors and alleviate joint synovial damage. 4. Animal experiments have also shown that EPH has a significant therapeutic effect on FCA-induced rheumatoid arthritis in rats, can improve the ankle joint circumference and paw volume, increase body weight, reduce joint inflammatory cell infiltration and cartilage damage, and reduce the levels of anti-dsDNA, anti-CarP, and anti-MCV in serum, and inhibit the expression of TLR8, MyD88, and TRAF6 proteins in joint tissue.

[0032] (6) Salvia miltiorrhiza: bitter, slightly cold. Belongs to heart and liver meridians. It has the functions of activating blood and removing blood stasis, unblocking channels and relieving pain, clearing heart and relieving restlessness, and cooling blood and resolving abscesses. It is commonly used to treat chest pain, abdominal and hypochondriac pain, fatigue accumulation, hot and painful, restlessness, insomnia, irregular menstruation, dysmenorrhea, and abscesses.

[0033] Modern pharmacological studies have shown that Salvia miltiorrhiza contains liposoluble diterpene quinones (such as tanshinone II A, cryptotanshinone), water-soluble phenolic acids (such as salvianolic acid B, danshensu), flavonoids, polysaccharides, and other components, which have anti-inflammatory, antioxidant, cardiovascular and cerebrovascular circulation improvement, anti-fibrosis, and immune regulation effects. 1. Tanshinone II A can reduce the expression of TNF-α, IL-6, IL-1β, and other pro-inflammatory factors by inhibiting the NF-κB signaling pathway, thereby reducing inflammation and improving inflammatory damage to joints and the cardiovascular system. 2. Phenolic acid components such as salvianolic acid B have significant antioxidant effects, can scavenge excess free radicals, and up-regulate the activity of antioxidant enzymes such as superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px), thereby protecting the heart, liver, and nerve cells from oxidative stress damage. 3. Liposoluble components (such as tanshinone II A) can inhibit the excessive proliferation of fibroblast-like synoviocytes, induce apoptosis, and regulate PI3K / Akt and Caspase signaling pathways, thereby delaying the progression of rheumatoid arthritis and other diseases. 4. Polysaccharide components in Salvia miltiorrhiza have immune regulation effects, can enhance the phagocytic function of macrophages, and promote the proliferation and differentiation of T lymphocytes, thereby improving the body's immunity.

[0034] (7) Achyranthes bidentata: bitter, sweet, sour, neutral. It enters the liver and kidney meridians. It has the functions of removing blood stasis and promoting menstruation, tonifying the liver and kidneys, strengthening tendons and bones, promoting urination and relieving strangury, and guiding blood downward. It is often used to treat amenorrhea, dysmenorrhea, soreness of the waist and knees, weakness of tendons and bones, strangury, edema, headache, dizziness, toothache, canker sores, hematemesis, epistaxis and other diseases.

[0035] Modern pharmacological studies have shown that Achyranthes bidentata contains active ingredients such as polysaccharides, saponins, flavonoids, and organic acids, which have multiple effects including immunomodulation, anti-inflammation, antioxidation, protection of articular cartilage, and improvement of bone metabolism. 1. Achyranthes bidentata polysaccharides can reduce the expression of inflammatory factors such as TNF-α, IL-6, and IL-1β by downregulating the MTA1 / NF-κB signaling pathway, inhibiting synovial inflammation, and alleviating joint swelling, cartilage damage, and bone erosion in rats with rheumatoid arthritis. 2. The polysaccharides and flavonoids in Achyranthes bidentata can scavenge free radicals, upregulate the activity of antioxidant enzymes such as SOD and GSH-Px, and reduce oxidative stress damage to chondrocytes and bone tissue. 3. Achyranthes bidentata polysaccharides can inhibit the abnormal proliferation of fibroblast-like synovial cells, improve synovial inflammation, regulate the function of T cells and macrophages, and delay the activation of inflammatory osteoclasts, thus playing a protective role in the joint. 4. Studies have found that Achyranthes bidentata polysaccharide can block pathways such as PPARγ / TRPV4, inhibit adipogenic differentiation of bone marrow mesenchymal stem cells, promote chondrocyte metabolism and bone formation, and has a positive intervention effect on osteoporosis and osteoarthritis.

[0036] (8) Prepared licorice root: sweet and neutral. It enters the heart, lung, spleen, and stomach meridians. It has the functions of tonifying the spleen and stomach, replenishing qi and restoring pulse. It is often used to treat symptoms such as spleen and stomach weakness, fatigue, palpitations, and irregular pulse.

[0037] Modern pharmacological studies show that the Radix Glycyrrhizae contains flavonoids (such as glycyrrhizin, glycyrrhizin charcotone A), triterpenoid saponins (such as 18β-glycyrrhizinic acid), coumarins, polysaccharides and other components. These components have anti-inflammatory, antioxidant, immunomodulatory and anti-angiogenic effects in inflammatory diseases and rheumatoid arthritis. 1. 18β-glycyrrhizin can inhibit the MAPK / NF-κB signaling pathway, reduce the levels of IL-6, IL-1β, COX-2 and other pro-inflammatory factors, induce synovial cell apoptosis and block the G1 phase of the cell cycle, thereby reducing inflammation and inhibiting excessive proliferation of joint synovial membrane. 2. Glycyrrhizin can promote synovial cell apoptosis by down-regulating the Bcl-2 / Bax ratio and changing the mitochondrial membrane potential; at the same time, it can inhibit VEGF expression and MAPK pathway phosphorylation, inhibit abnormal angiogenesis, and play an anti-inflammatory and joint protective role. 3. Glycyrrhizin charcotone A can activate the Keap1-Nrf2 signaling pathway, increase the level of cellular antioxidant enzymes, and reduce free radical damage; at the same time, it can inhibit the secretion of inflammatory factors, block the cell cycle and induce apoptosis, and exhibit dual effects of anti-inflammatory and antioxidant. 4. Glycyrrhizol can inhibit the activation of iNOS, COX-2 and NF-κB, reduce the levels of serum TNF-α, IL-1β, IL-6, IL-17 and MMPs, regulate immune inflammatory response, and improve the inflammatory state of rheumatoid arthritis. 5. Polysaccharide components in Glycyrrhiza have immunomodulatory effects, can regulate the Th17 / Treg cell ratio, repair intestinal barrier function, maintain the "gut-joint axis" homeostasis, thereby improving the immune imbalance state of rheumatoid arthritis patients and enhancing the immune function of the body.

[0038] The compatibility of the above-mentioned traditional Chinese medicine composition of the application is analyzed as follows: the present prescription follows the compatibility principle of "monarch, minister and assistant", and mainly treats joint cold pain and stubborn arthralgia caused by wind-cold-dampness by warming the meridians, dispelling wind and dredging collaterals, tonifying qi and supporting the healthy, and promoting blood circulation to remove blood stasis. The cause of the disease is mostly wind-cold-dampness evil blocking the meridians, and the smooth running of qi and blood is not smooth. If it is long, the blood stasis is blocked and the healthy is deficient, and the joint pain is stubborn and not cured. Therefore, the present prescription mainly warms the meridians and tonifies qi, and is supplemented by promoting blood circulation to remove blood stasis and relaxing the tendons and dredging the collaterals. The specific compatibility is as follows: Monarch: prepared ephedra. Prepared ephedra can warm the meridians, dispel wind and relieve pain, and is good at treating cold arthralgia and cold pain. It is the main drug of the whole prescription and dominates the functions of expelling evil and relieving pain.

[0039] Minister: Astragalus, Codonopsis, Cinnamon Twig, Ephedra. Astragalus can tonify qi and support the exterior, tonify qi and support evil, and can not only tonify the healthy and supplement the deficiency, but also enhance the resistance to evil. Codonopsis can invigorate the spleen and tonify qi, and can tonify the middle qi. Together, they can enhance the body's healthy qi. Cinnamon Twig can warm the meridians, relax the tendons and activate the collaterals, and Ephedra can dispel wind and cold and relieve pain. Together with the monarch, they can further consolidate the effects of warming the meridians, dispelling wind and dredging collaterals. Tonifying and expelling evil are used together, and the deficiency and excess are considered together, which is the minister.

[0040] Adjuvant herbs: Salvia miltiorrhiza and Achyranthes bidentata. Salvia miltiorrhiza invigorates blood circulation, removes blood stasis, unblocks meridians, and relieves pain, making it suitable for chronic arthralgia due to blood stasis. Achyranthes bidentata invigorates blood circulation, unblocks meridians, strengthens tendons and bones, and can guide blood downwards, assisting Salvia miltiorrhiza in removing blood stasis, unblocking meridians, relaxing muscles, and relieving pain. The combination of the two can improve stubborn arthralgia due to blood stasis and also nourish tendons and bones, thus serving as adjuvant herbs.

[0041] The main ingredient is roasted licorice root. Roasted licorice root invigorates qi, harmonizes the middle jiao, relieves spasms and pain, and can also harmonize the properties of other herbs, making the entire formula balanced, potent but not harmful to the body's vital energy.

[0042] The formula uses processed Aconitum carmichaelii as the chief ingredient to warm the meridians, dispel cold, and relieve wind and pain; Astragalus membranaceus, Codonopsis pilosula, Cinnamomum cassia, and Ephedra sinica as assistant ingredients to invigorate qi and support the body's resistance, as well as to dispel wind and cold, taking into account both deficiency and excess; Salvia miltiorrhiza and Achyranthes bidentata as adjuvant ingredients to invigorate blood, remove blood stasis, and relax muscles and bones; and Glycyrrhiza uralensis as the guiding ingredient to harmonize the various herbs, invigorate qi, and relieve spasms.

[0043] This formula works synergistically to warm the meridians and dispel cold, expel wind and unblock the collaterals, invigorate qi and strengthen the body's resistance, and promote blood circulation and remove blood stasis. It also possesses anti-inflammatory, immunomodulatory, and analgesic effects, making it suitable for wind-cold-dampness arthralgia and stubborn joint pain. It treats both the symptoms and the root cause, with definite curative effects. Clinical application shows that this formula has the advantages of definite efficacy, high safety, no toxic side effects, short treatment period, no recurrence, and improvement of joint pain and function.

[0044] Compared with the prior art, the present invention has the following technical advantages: (1) The traditional Chinese medicine composition of the present invention is convenient to take, has a definite curative effect, and is simple to combine. It has an effective rate of up to 84.8% in treating rheumatoid arthritis of the wind-cold-dampness type, and no obvious toxic side effects have been observed. It has the advantages of safe medication, moderate treatment course and low recurrence rate. It has good clinical application value and can generate significant economic and social benefits.

[0045] (2) The invented Chinese herbal medicine combination formula follows the principle of "principal, assistant, adjuvant, and guide" in its formulation. It mainly treats joint pain and stubborn arthralgia caused by wind-cold-dampness by warming the meridians and dispelling cold, dispelling wind and unblocking the collaterals, tonifying qi and strengthening the body, and promoting blood circulation and removing blood stasis. The whole formula takes processed aconite root as the principal ingredient to warm the meridians and dispel cold, dispel wind and relieve pain; astragalus root, codonopsis root, cinnamon twig, and ephedra as the assistant ingredients to tonify qi and strengthen the body, and also to help dispel wind and dispel cold, taking into account both deficiency and excess; salvia root and achyranthes root as the adjuvant ingredients to promote blood circulation, remove blood stasis, relax muscles and strengthen bones; and prepared licorice root as the guide ingredient to harmonize the other herbs, tonify qi and relieve spasms. The whole formula works together to warm the meridians and dispel cold, dispel wind and unblock the collaterals, tonify qi and strengthen the body, and promote blood circulation and remove blood stasis. It also has anti-inflammatory, immunomodulatory and analgesic effects. It is suitable for wind-cold-dampness arthralgia and stubborn arthralgia caused by cold, cold and dampness, treating both the root cause and the symptoms, with definite curative effect. Clinical application shows that this formula has the advantages of definite curative effect, high safety, no toxic side effects, short treatment cycle, no recurrence, and can improve joint pain and function.

[0046] (3) The traditional Chinese medicine composition of the present application only contains eight raw materials, and the compatibility is simple, coordinated, simple, efficient, and in line with the concept of traditional Chinese medicine syndrome differentiation and treatment. It can retain many active substances and avoid the destruction of heat-sensitive or polar compounds by alcohol extraction. It is more in line with the theoretical basis of the overall synergy and compatibility of monarch, minister, assistant and guide of traditional Chinese medicine. DETAILED DESCRIPTION

[0047] The present application will be described in detail below in conjunction with the drawings and specific embodiments. The present embodiment is implemented on the premise of the technical solution of the present application, and gives a detailed implementation and specific operation process, but the protection scope of the present application is not limited to the following examples.

[0048] Unless otherwise specified, the reagents, methods, instruments and equipment used in the present application are conventional reagents, methods, instruments and equipment in the art. Unless otherwise specified, the reagents and materials used in the following examples are commercially available.

[0049] All traditional Chinese medicine decoction pieces of the present application are provided by the Chinese medicine pharmacy of the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine.

[0050] Example 1 The present embodiment provides a traditional Chinese medicine composition for treating rheumatoid arthritis of wind-cold-dampness obstruction type, which specifically comprises the following weight of traditional Chinese medicine raw materials: Radix Astragali 15g, Radix Codonopsis 9g, Ramulus Cinnamomi 9g, Radix et Rhizoma Aconiti Preparata 3g, Ephedra 6g, Radix Salviae Miltiorrhizae 9g, Radix Hedysari 9g, Radix Glycyrrhizae Preparata 9g.

[0051] The water decoction of the present embodiment is prepared as follows: (1) Preparation of medicinal materials: Mix all medicinal materials, pick out impurities, rinse with pure water, and filter dry for standby.

[0052] (2) Soaking: Put Radix et Rhizoma Aconiti Preparata alone in a sand pot or ceramic decoction device, add about 200 mL of cold water; put the remaining medicinal materials in another container, add about 600 mL of cold water, and soak all medicinal materials for 30 minutes to allow them to fully absorb water, which is beneficial to the decoction of effective components.

[0053] (3) First decoction: After the decoction device with soaked Radix et Rhizoma Aconiti Preparata is boiled, cover it and change to a medium fire, and decoct it alone for 30 minutes.

[0054] (4) First decoction: After the decoction device with soaked Radix et Rhizoma Aconiti Preparata is boiled, cover it and change to a medium fire, and decoct it alone for 30 minutes.

[0055] (5) Second decoction: Add 600 mL of water and decoct for 25 minutes in the same way, filter the juice; combine the two decoctions and stir well for standby.

[0056] (6) Taking method: one dose per day, take twice, recommended to take at 9-10 am and 3-4 pm, so as to facilitate absorption.

[0057] Example 2 The embodiment provides a traditional Chinese medicine composition for treating rheumatoid arthritis of wind-cold-dampness obstruction type, and the difference from the embodiment 1 is that the traditional Chinese medicine composition specifically comprises the following weight of traditional Chinese medicine raw materials: 14g of Astragalus, 8g of Codonopsis, 9g of Ramulus Cinnamomi, 2g of Radix et Rhizoma Aconiti Preparata, 7g of Ephedra, 8g of Salvia, 8g of Prepared Radix Achyranthis Bidentatae, and 10g of Radix Glycyrrhizae. The preparation method of the water decoction is referred to the embodiment 1.

[0058] Example 3 The embodiment provides a traditional Chinese medicine composition for treating rheumatoid arthritis of wind-cold-dampness obstruction type, and the difference from the embodiment 1 is that the traditional Chinese medicine composition specifically comprises the following weight of traditional Chinese medicine raw materials: 16g of Astragalus, 10g of Codonopsis, 10g of Ramulus Cinnamomi, 4g of Radix et Rhizoma Aconiti Preparata, 5g of Ephedra, 10g of Salvia, 9g of Prepared Radix Achyranthis Bidentatae, and 8g of Radix Glycyrrhizae. The preparation method of the water decoction is referred to the embodiment 1.

[0059] Example 4 The embodiment provides a traditional Chinese medicine composition for treating rheumatoid arthritis of wind-cold-dampness obstruction type, and the difference from the embodiment 1 is that the traditional Chinese medicine composition specifically comprises the following weight of traditional Chinese medicine raw materials: 10g of Astragalus, 6g of Codonopsis, 6g of Ramulus Cinnamomi, 2g of Radix et Rhizoma Aconiti Preparata, 4g of Ephedra, 6g of Salvia, 6g of Prepared Radix Achyranthis Bidentatae, and 6g of Radix Glycyrrhizae. The preparation method of the water decoction is referred to the embodiment 1.

[0060] Clinical effect verification Taking the traditional Chinese medicine composition of the embodiment 1 as an example, volunteers are recruited to carry out tests, and good clinical treatment effects are obtained.

[0061] I. Diagnosis standard of rheumatoid arthritis of wind-cold-dampness obstruction type 1. Clinical manifestations Rheumatoid arthritis of wind-cold-dampness obstruction type refers to joint swelling, pain and other symptoms caused by external wind-cold-dampness evil, which blocks collaterals and joints, and blood circulation is not smooth. It is often seen in people who are long-term in a cold and humid environment, have weak constitution or lack of yangqi. The main clinical manifestations include: joint swelling and pain, fixed pain, obvious morning stiffness, flexion and extension are difficult, pain is severe when cold, local cold and cold, joint movement is limited. It can be accompanied by general cold, cold limbs, and fatigue. Thin white tongue fur, pulse is mostly floating tight or sinking tight. The course of the disease is mostly chronic and recurrent, and the symptoms are obviously aggravated when cold and dampness invades. After excluding other rheumatic diseases, it can be diagnosed.

[0062] 2. Auxiliary examination Laboratory examination: erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and rheumatoid factor (RF) can be slightly elevated; anti-CCP antibody is positive.

[0063] Radiological examination: X-ray and MRI can show joint soft tissue swelling, early stage without obvious bone destruction; some cases can show joint space narrowing or mild osteoporosis.

[0064] Ultrasonic examination: a small amount of effusion in the joint cavity or slight thickening of the synovial membrane.

[0065] TCM syndrome differentiation: combined with tongue and pulse characteristics (thin white fur, floating and tight pulse or sinking tight pulse) for reference in syndrome differentiation. According to the joint symptoms, daily function and objective examination, the rheumatoid arthritis of wind-cold-dampness obstruction type is divided into three categories: mild, moderate and severe. Mild (I degree): mild joint pain, mainly after cold or fatigue; short morning stiffness; slight impact on daily activities. Physical examination shows mild tenderness and normal joint mobility.

[0066] Moderate (II degree): joint pain is more obvious, morning stiffness is prolonged (> 30 minutes), and symptoms are significantly aggravated after activity. Daily life and work are limited, and there is obvious tenderness and mild to moderate mobility disorder in joint examination.

[0067] Severe (III degree): persistent joint pain, often severe, with pulling pain or stinging pain; long morning stiffness (> 60 minutes), joint mobility is significantly limited, and the quality of life is severely decreased. Physical examination shows joint swelling, stiffness, and significant mobility disorder, and patients often need drug relief.

[0068] 4. Inclusion criteria The following conditions are included in the study: Meet the diagnostic criteria for rheumatoid arthritis, and the TCM syndrome is of wind-cold-dampness obstruction type.

[0069] The main symptoms are joint swelling and pain, aggravation with cold, and difficulty in morning stiffness and stretching.

[0070] Age 18-65 years old, male and female.

[0071] Clear consciousness, can cooperate with treatment and follow-up, and have independent judgment ability.

[0072] Volunteer to participate in this study and sign the informed consent form.

[0073] 5. Exclusion criteria The following conditions are not included in the study: Combined with other rheumatic diseases (such as systemic lupus erythematosus, ankylosing spondylitis, gout, etc.).

[0074] Combined with severe heart, brain, liver, kidney and other important organ diseases or dysfunction.

[0075] Pregnant or lactating women, or women planning to get pregnant in the near future.

[0076] People with mental disorders or cognitive dysfunction.

[0077] People allergic to the drugs or related ingredients.

[0078] 6. Drop-out and exclusion criteria During the treatment and research, the following cases should be excluded or treated as drop-out cases: Severe adverse reactions occur during treatment, and the patient cannot continue to receive treatment.

[0079] Poor compliance with regular medication according to the protocol, affecting the judgment of efficacy.

[0080] Midway withdrawal or request to withdraw from the study.

[0081] Incomplete original data, unable to assess efficacy.

[0082] II. Treatment regimen Take the compound decoction (for example, composed of Huangqi, Dangshen, Guizhi, Shuizhengwuyu, Mahuang, Danshen, Huai Niuxi, Zhigancao) orally, 1 dose per day, decocted with water to obtain juice, taken twice a day, preferably at 9-10 am and 3-4 pm, to facilitate absorption.

[0083] Each month is a course of treatment, and the efficacy is calculated after 4 consecutive courses of treatment. In actual clinical treatment, some patients with mild symptoms may show effectiveness or even be cured after 1 course of treatment, but the final efficacy is still calculated based on 4 courses of treatment.

[0084] III. Efficacy evaluation criteria 1. Cure: Joint swelling, pain, tenderness, morning stiffness, and joint function recovery; Laboratory indicators (RF, ESR, CRP) returned to normal; Imaging examination (X-ray / ultrasound / MRI) showed no new bone destruction in the joint and synovitis subsided; Functional score: DAS28 ≤ 2.6 (clinical remission); Functional disability index: HAQ-DI ≤ 0.5 (close to no obstacles); No recurrence after 4 months of follow-up.

[0085] 2. Marked effect: Joint swelling, pain, tenderness symptoms were significantly relieved (≥ 50%), and morning stiffness time was shortened by ≥ 50%; Laboratory indicators improved significantly (RF, ESR, CRP decreased by ≥ 50%); Imaging examinations (X-ray / ultrasound / MRI) showed no new bone destruction in the joints, and synovitis was significantly improved; Functional score: 2.6 < DAS28 ≤ 3.2 (mild activity); Functional disability index: 0.5 < HAQ-DI ≤ 1.0 (mild functional impairment).

[0086] 3. Effective: Symptoms of joint swelling, pain, and tenderness were somewhat alleviated (<50%), and morning stiffness was not significantly improved; Laboratory indicators were partially improved (RF, ESR, CRP decreased by <50%); Imaging examinations (X-ray / ultrasound / MRI) showed limited progression or basic stability of joint bone destruction, and synovitis was not significantly improved; Functional score: 3.2 < DAS28 ≤ 5.1 (moderate activity); Functional disability index: 1.0 < HAQ-DI ≤ 2.0 (moderate functional impairment).

[0087] 4. Ineffective: There was no significant improvement in joint symptoms and laboratory indicators, or the condition worsened with the appearance of new joint deformities; Imaging examinations (X-ray / ultrasound / MRI) showed aggravated bone destruction or joint cavity stenosis; Functional score: DAS28 > 5.1 (high activity); Functional disability index: HAQ-DI > 2.0 (severe functional impairment), and other medications need to be changed for treatment.

[0088] IV. Statistical analysis In this study, a total of 92 rheumatoid arthritis patients were included and treated with the traditional Chinese medicine composition of the present invention.

[0089] After statistical analysis of the treatment results, it was shown that: 1. As shown in Table 1, there were 20 cured patients, 42 markedly effective patients, 16 effective patients, and 14 ineffective patients, with a total effective rate of 84.8%. No obvious adverse reactions were observed during the treatment process. Most patients had stable symptoms and a stable mood within 4 months of follow-up, and there was no serious recurrence.

[0090] Table 1 Comparison of curative effects (cases (%)) 2、As shown in Table 2, in the laboratory index examination of 92 patients, the average value of rheumatoid factor (RF) before treatment was 98.6±10.3 U / mL, which was significantly reduced to 33.8±5.1 U / mL after treatment; the average value of ESR before treatment was 44.6±4.7 U / mL, which was significantly reduced to 20.1±3.5 after treatment; the average value of C-reactive protein before treatment was 38.2±16.7 U / mL, which was significantly reduced to 8.1±4.9 U / mL after treatment.

[0091] Table 2 Comparison of laboratory indexes ±s) Compared with the treatment group, *P<0.05.

[0092] 3、As shown in Table 3, the DAS28 score after treatment was significantly reduced from 4.8±0.3 to 1.2±0.2, which was much smaller than 2.6, indicating that most patients had clinical remission.

[0093] Table 3 Comparison of DAS28 scores before and after treatment ±s) Compared with the treatment group, *P<0.05.

[0094] 4、As shown in Table 4, the HAQ-DI functional disability index after treatment was significantly reduced from 1.9±0.5 to 0.7±0.4, indicating that most patients had clinical remission.

[0095] Table 4 Comparison of HAQ-DI functional disability index scores before and after treatment ±s) Compared with the treatment group, *P<0.05.

[0096] Five, classic cases 1、Zhang, female, 60 years old, from Baoshan District of Shanghai, diagnosed with rheumatoid arthritis, with a course of 23 years. The patient had joint swelling and pain in both hands 23 years ago, with morning stiffness of about 60 minutes, which could be relieved after exercise. The symptoms have worsened in the past 2 years, and the joints of both hands are deformed. The tongue is pale red, the fur is thin and white, and the pulse is thin. After treatment with the drug combination of the application, the joint pain is significantly relieved, and the activity is improved. Follow-up for 4 months, the symptoms are stable and there is no recurrence.

[0097] 2. Chen, female, 41 years old, from Jiaxing City, Zhejiang Province, diagnosed with rheumatoid arthritis, with a course of 15 years. The patient had multiple joint cold pain and flexion-extension difficulty at the onset, and later gradually developed joint deformity. She had been treated with long-term alternating Chinese and Western medicine, and had repeated joint cold pain. The tongue was pale red, with a white and greasy fur, and the pulse was tight. After 1 course of treatment with the drug combination of the application, the symptoms were significantly reduced, and after 2 courses, the joint pain was relieved and sleep was improved. Follow-up for 4 months showed that the joint swelling and pain were significantly reduced.

[0098] 3. Li, female, 53 years old, from Luoyang City, Henan Province, diagnosed with rheumatoid arthritis, with a course of 5 years. The patient had swelling and pain in both feet 5 years ago, accompanied by morning stiffness, and later gradually involved multiple joints, with right knee joint swelling and pain being more severe in the past month. The tongue was pale red, with a thin white fur, and the pulse was tight. After 1 course of treatment with the drug combination of the application, the symptoms were significantly improved, and after 4 courses, the patient was cured. There was no recurrence during the follow-up period.

[0099] Rheumatoid arthritis of wind-dampness obstruction type is one of the common chronic autoimmune diseases in clinical practice. Western medicine believes that its pathogenesis is mainly related to immune dysfunction, abnormal activation of inflammatory cells and cytokines, and often involves synovium, cartilage and joint bone, presenting as symmetrical arthritis, with synovitis and pannus formation as the main characteristics, gradually leading to joint destruction and deformity. The understanding of traditional Chinese medicine for this disease is more macroscopic and dynamic. The fundamental pathogenesis is "asthenia in origin and excess in superficiality": liver and kidney deficiency, deficiency of qi and blood are the internal cause and the root of the disease, while wind-cold-dampness invasion and phlegm and blood stasis are the superficial cause and the superficial manifestation. The key is that the internal "yin and wei disharmony" is the prerequisite for external wind-cold-dampness invasion and obstruction of meridians, which is the reverse of "Zhenqi stored inside, evil cannot attack" in Huangdi Neijing. In the early stage of pathological evolution, the main symptom is joint swelling and pain; as the disease progresses, phlegm and blood stasis grow, damaging the healthy qi, leading to liver and kidney deficiency, and finally causing joint deformity.

[0100] Based on this pathogenesis, the treatment should adhere to the general principle of "strengthening the body resistance and eliminating evil", combining regulating yin and wei, tonifying liver and kidney to consolidate the root, and eliminating wind, dispelling cold and dampness, promoting blood circulation and removing blood stasis to treat the superficial symptoms. Clinical practice shows that traditional Chinese medicine treatment guided by this theory can effectively relieve joint swelling and pain, improve flexion-extension function and delay disease progression. Related clinical observations show that the effective rate of this treatment regimen is 84.8%, and the safety is good, without obvious side effects, which reflects the comprehensive advantages of safe medication, stable efficacy and low recurrence rate.

[0101] Therefore, in-depth exploration and systematic application of the traditional Chinese medicine diagnosis and treatment strategy focusing on "regulating yin and wei" and coordinating external wind-cold-dampness and internal liver-spleen-kidney deficiency has important clinical value and wide social significance for innovating the treatment of rheumatoid arthritis of wind-dampness obstruction type, improving clinical efficacy, and reducing the economic burden on patients and society.

[0102] The foregoing description of the embodiments has been presented for the purpose of illustration and description. It is not intended to be exhaustive or to limit the application to the precise form disclosed. Modifications and variations are possible in light of the above teachings or can be acquired from practice of the application. As well, the description is presented in the context of the preferred embodiments as a number of alternatives. It is not intended to limit the application to the precise form described.

Claims

1. A traditional Chinese medicine composition for treating rheumatoid arthritis of the wind-cold-dampness type, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 13-17 parts, Codonopsis pilosula 7-11 parts, Cinnamomum cassia 7-11 parts, Aconitum carmichaelii (processed) 2-4 parts, Ephedra sinica 4-8 parts, Salvia miltiorrhiza 7-11 parts, Achyranthes bidentata 7-11 parts, Glycyrrhiza uralensis (processed) 7-11 parts.

2. The traditional Chinese medicine composition for treating rheumatoid arthritis of the wind-cold-dampness type according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 14-16 parts, Codonopsis pilosula 8-10 parts, Cinnamomum cassia 8-10 parts, Aconitum carmichaelii (processed) 2-4 parts, Ephedra sinica 5-7 parts, Salvia miltiorrhiza 8-10 parts, Achyranthes bidentata 8-10 parts, Glycyrrhiza uralensis (processed) 8-10 parts.

3. The traditional Chinese medicine composition for treating rheumatoid arthritis of the wind-cold-dampness type according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 15 parts, Codonopsis pilosula 9 parts, Cinnamomum cassia 9 parts, Aconitum carmichaelii (processed) 3 parts, Ephedra sinica 6 parts, Salvia miltiorrhiza 9 parts, Achyranthes bidentata 9 parts, Glycyrrhiza uralensis (processed) 9 parts.

4. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for treating rheumatoid arthritis of the wind-cold-dampness type, characterized in that, The drug is an oral preparation, including any one of the following: decoction, granules, lyophilized powder, tablets, capsules, pills, oral liquid or syrup.

5. The application of the traditional Chinese medicine composition according to claim 4 in the preparation of a drug for treating rheumatoid arthritis of the wind-cold-dampness type, characterized in that, The drug also includes pharmaceutically acceptable excipients.

6. The application of the traditional Chinese medicine composition according to claim 4 in the preparation of a drug for treating rheumatoid arthritis of the wind-cold-dampness type, characterized in that, The preparation method of the decoction is as follows: S1: Prepare the medicinal materials, wash them, drain them, and set them aside; S2: Place the prepared Aconitum carmichaelii in a separate container and add cold water to soak; place the other medicinal materials in a separate container and add cold water to soak. S3: First decoct the prepared aconite root; S4: After the processed Aconitum carmichaelii is decocted first, the remaining medicinal materials are added for the first decoction, and the first decoction is obtained by filtration. S5: Add water and boil a second time, then filter to obtain the second decoction; S6: Combine the two decoctions, stir well and set aside.

7. The application of the traditional Chinese medicine composition according to claim 6 in the preparation of a drug for treating rheumatoid arthritis of the wind-cold-dampness type, characterized in that, In step S2, the prepared Aconitum carmichaelii is soaked in 150-250 mL of cold water for 20-40 min; the other medicinal materials are soaked in 500-700 mL of cold water for 20-40 min.

8. The use of the traditional Chinese medicine composition according to claim 6 in the preparation of a drug for treating rheumatoid arthritis of the wind-cold-dampness type, characterized in that, In step S3, the decoction time is 20-40 minutes.

9. The use of the traditional Chinese medicine composition according to claim 6 in the preparation of a drug for treating rheumatoid arthritis of the wind-cold-dampness type, characterized in that, In step S4, the specific operation of the first decoction is to bring it to a boil over high heat, then turn to low heat and continue to decoct for 20 to 40 minutes to obtain 200 to 300 mL of the first decoction.

10. The use of the traditional Chinese medicine composition according to claim 6 in the preparation of a drug for treating rheumatoid arthritis of the wind-cold-dampness type, characterized in that, In step S5, the specific operation of the second decoction is to add 500-700 mL of water to the dregs from the first decoction, bring it to a boil over high heat, then simmer over low heat for 20-40 minutes to obtain 200-300 mL of the second decoction.

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