Traditional Chinese medicine composition for treating wind-cold-dampness retention type rheumatoid arthritis, plaster and preparation thereof

Abstract

The invention relates to a traditional Chinese medicine composition for treating wind-cold-dampness retention type rheumatoid arthritis, an application and a preparation method of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 85 to 95 parts of baked ginger, 12 to 18 parts of cortex cinnamomi, 25 to 35 parts of rhizoma arisaematis, 85 to 95 parts of radix paeoniae rubra, 25 to 35 parts of radix angelicae, 85 to 95 parts of radix aconiti agrestis, 7 to 11 parts of raw frankincense, 4 to 6 parts of raw myrrh, 7 to 11 parts of gallnut and 7 to 11 parts of semen brassicae. Compared with the prior art, the traditional Chinese medicine composition disclosed by the invention can be used for effectively treating wind-cold-dampness blocking type rheumatoid arthritis in an external application mode, and is high in safety, free of obvious toxic and side effects and remarkable in clinical application value.

Description

Technical Field

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

[0002] Rheumatoid arthritis of the wind-cold-dampness type is a chronic autoimmune disease characterized by joint swelling, stiffness, deformity, limited flexion and extension, and bone damage. Western medicine believes its occurrence is closely related to immune tolerance imbalance, with abnormal activation of inflammatory cells and various cytokines inducing synovitis and pannus formation, subsequently destroying cartilage and bone. Clinically, it often involves symmetrical small joints, commonly affecting the hands, wrists, and knees, and is frequently accompanied by morning stiffness, fatigue, low-grade fever, anemia, and other systemic symptoms. Prolonged disease progression can lead to deformities and functional loss, severely impacting quality of life. Epidemiological data shows a global incidence of approximately 0.5%–1%, with a male-to-female ratio of about 1:3, and a peak age of onset between 30 and 50 years. Wind-cold-dampness obstruction is a common clinical pattern, characterized by aggravated pain upon exposure to cold, localized pain, and pronounced morning stiffness.

[0003] Based on the external symptoms and syndrome characteristics of rheumatoid arthritis of the wind-cold-dampness type, it can be classified under the categories of "Bi syndrome" and "arthritis" in traditional Chinese medicine. Its core etiology lies in the invasion of wind, cold, and dampness. The *Suwen* (Plain Questions) states, "When wind, cold, and dampness combine, they cause Bi syndrome," clearly indicating that external pathogenic invasion is the direct cause of Bi syndrome. The *Lingshu* (Spiritual Pivot) states, "Wind, cold, and dampness invade the external muscles… causing pain when they split," profoundly explaining the specific mechanism by which pathogenic factors invade the body surface, obstructing the meridians and leading to pain and functional impairment. In this process, external pathogenic factors obstruct the meridians on the body surface, causing poor circulation of Qi and blood, abnormal distribution of body fluids, and the accumulation of phlegm and blood stasis, which block the joints and bones, thus manifesting as a series of symptoms such as joint swelling, stiffness, and deformity. The *Suwen* also states, "Wei Qi is the robust Qi of water and grain… following its Qi leads to healing; it does not combine with wind, cold, and dampness, therefore it does not cause Bi syndrome," emphasizing that deficiency of the body's vital energy is the foundation of this disease. Throughout history, physicians have generally believed that disharmony between the Ying and Wei (nutritive and defensive qi) and loose pores allow wind, cold, and dampness to invade, obstructing the meridians and causing sluggish circulation of qi and blood. Over time, this leads to "chronic disease entering the collaterals," causing stagnation in the collaterals, malnourishment of the muscles and bones, and gradual swelling, stiffness, and limited range of motion in the joints. The essential pathogenesis can be summarized as "deficiency of the root and excess of the branch": the root lies in deficiency of the liver and kidneys and insufficiency of spleen qi, while the branch lies in the obstruction of wind, cold, and dampness and blockage of the collaterals; prolonged stagnation of cold and dampness leads to the retention of body fluids and the formation of phlegm, hindering the flow of qi and blood, eventually resulting in blood stasis. The mutual binding of phlegm and blood stasis exacerbates the disease.

[0004] The theory of "wind, cold, and dampness causing arthralgia" is one of the core concepts in traditional Chinese medicine's understanding of this disease. "Wind" is mobile and constantly changing, causing symptoms to shift and become unpredictable; "cold" is characterized by contraction and stagnation, leading to severe joint pain and difficulty in flexion and extension when exposed to cold; "dampness" is heavy, turbid, and sticky, causing heaviness, swelling, and contracture of the limbs. These three factors can act alone or in combination, attacking the muscles and meridians externally and interacting with the body's inherent weaknesses internally, causing stagnation of Qi, disharmony of Ying and Wei (nutritive and defensive Qi), and obstruction of the joints and meridians, resulting in pain. Cold causes blood stasis, dampness obstructs Qi flow, and wind causes the symptoms to prolong. With prolonged obstruction, body fluids condense into phlegm, and blood stasis is formed due to obstructed blood circulation. The mutual binding of phlegm and blood stasis further exacerbates the obstruction and swelling, forming a pathological pattern of "cold causing contraction, dampness causing stickiness, and wind causing wandering," which is corroborated by modern findings such as synovial inflammatory hyperplasia, microcirculatory disturbances, and abnormal activation of inflammatory mediators. The three pathogenic factors of wind, cold, and dampness, along with a weak constitution, are mutually causal, causing the patient's illness to be protracted and recurring. Clinical treatment should focus on both strengthening the body's resistance and eliminating pathogenic factors, removing wind, cold, and dampness from the body surface and meridians, and resolving the phlegm and blood stasis caused by them, in order to relieve pain, improve joint mobility, and reduce recurrence.

[0005] CN1294984C discloses a traditional Chinese medicine composition for treating rheumatism and rheumatoid arthritis, including an external paste and an internal medicated wine. The external paste contains herbs such as Aconitum carmichaelii, Arisaema heterophyllum, Paeonia lactiflora, Angelica dahurica, Cinnamomum cassia, and Zingiber officinale. The internal medicated wine contains herbs such as Vinegarita dahurica, Hemp arvense, Platycodon grandiflorus, Sargentodoxa cuneata, Sargentodoxa cuneata, and Cinnamomum camphora root, which are soaked in grain liquor. The combination of internal and external application is used to achieve a therapeutic effect. However, this treatment method, which combines internal and external application, is not only cumbersome but also poses significant safety risks: excessive or prolonged skin contact with the externally applied Aconitum carmichaelii and Arisaema heterophyllum can easily lead to poisoning, while the internal medicated wine allows alcohol and drug components to directly enter the body, creating a double exposure risk of toxic components and alcohol, raising concerns about overall safety.

[0006] CN101972464B discloses a traditional Chinese medicine composition for treating rheumatoid arthritis and its preparation method. The composition comprises 20 herbs, including Aconitum carmichaelii, Aconitum kusnezoffii, Pinellia ternata, and Arisaema heterophyllum. After soaking in 75% alcohol for 14 days, it is prepared as a topical tincture for external application. It combines insect-derived herbs with multiple drugs for synergistic effects and improved efficacy. However, this formula is a complex compound of 20 herbs with intricate ingredients and an unreasonable combination. The reliance on alcohol extraction makes it prone to skin irritation. Furthermore, the highly toxic herbs such as Aconitum carmichaelii, Strychnos nux-vomica, and Datura stramonium can easily trigger local or systemic poisoning reactions during the preparation of the tincture. Therefore, strict dosage control and comprehensive protective and monitoring measures must be implemented in clinical applications.

[0007] While various traditional Chinese medicine formulas for treating rheumatoid arthritis of the wind-cold-dampness type can alleviate symptoms to some extent, their use and efficacy are not satisfactory due to unreasonable composition and complex preparation and usage methods. There is still room for improvement in terms of multi-target synergy of formula composition, immune regulation and joint protection, and prevention of recurrence.

[0008] Therefore, novel topical Chinese medicine compositions for treating rheumatoid arthritis of the wind-cold-dampness type still need to be developed. Summary of the Invention

[0009] The purpose of this invention is to overcome at least one of the defects in the prior art, such as unreasonable composition, complex preparation and use methods, and difficulty in controlling efficacy, and to provide a traditional Chinese medicine composition, application, and preparation thereof for treating rheumatoid arthritis of the wind-cold-dampness type.

[0010] The objective of this invention can be achieved through the following technical solutions: This invention first provides a traditional Chinese medicine composition for treating rheumatoid arthritis of the wind-cold-dampness type. The traditional Chinese medicine composition consists of the following parts by weight: 85-95 parts of dried ginger, 12-18 parts of cinnamon, 25-35 parts of arisaema, 85-95 parts of red peony root, 25-35 parts of angelica root, 85-95 parts of aconite, 7-11 parts of raw frankincense, 4-6 parts of raw myrrh, 7-11 parts of gallnut, and 7-11 parts of white mustard seed.

[0011] Furthermore, the traditional Chinese medicine composition comprises the following parts by weight: 87-93 parts of dried ginger, 14-16 parts of cinnamon, 28-32 parts of arisaema, 87-93 parts of red peony root, 28-32 parts of angelica dahurica, 87-93 parts of aconite, 8-10 parts of raw frankincense, 4-6 parts of raw myrrh, 8-10 parts of gallnut, and 8-10 parts of white mustard seed.

[0012] Furthermore, the traditional Chinese medicine composition comprises the following parts by weight: 90 parts of dried ginger, 15 parts of cinnamon, 30 parts of arisaema, 90 parts of red peony root, 30 parts of angelica dahurica, 90 parts of aconite, 9 parts of raw frankincense, 5 parts of raw myrrh, 9 parts of gallnut, and 9 parts of white mustard seed.

[0013] The present invention also provides a poultice, wherein the poultice uses a traditional Chinese medicine composition for treating rheumatoid arthritis of the wind-cold-dampness type as the active ingredient.

[0014] Furthermore, the dressing consists of a dressing carrier and a medicated paste layer uniformly coated on the dressing carrier, wherein the medicated paste layer is prepared by mixing traditional Chinese medicine powder and rice wine.

[0015] Furthermore, the dressing carrier is gauze or non-woven fabric, and the dressing carrier covers the lesion.

[0016] Furthermore, the thickness of the medicated paste layer is 2-3 mm.

[0017] Furthermore, the amount of the traditional Chinese medicine composition powder used is 8-15 g per joint.

[0018] Furthermore, the dosage for small joints is 8-11 g, and the dosage for large joints is 12-15 g.

[0019] Furthermore, the dosage relationship between the herbal medicine composition powder and rice wine is 1 g powder to 1.0~1.2 mL rice wine.

[0020] The present invention also provides a method for preparing a dressing, the method comprising the following steps: S1. Preparation of medicinal materials: Wash and dry all kinds of medicinal materials for later use; S2. Grinding and sieving: Grind and mix all kinds of medicinal materials evenly, and then sieve them for later use; S3. Prepare the paste: Mix the fine powder obtained after sun-drying with rice wine in a certain proportion to form a thick paste. S4. Spreading: The obtained paste is evenly spread onto the dressing carrier to obtain the dressing.

[0021] Furthermore, in step S2, the grinding and sieving specifically involves passing the material through an 80-100 mesh sieve.

[0022] Furthermore, in step S3, the temperature of the rice wine is 35~45 ℃.

[0023] Among the above components, which are: (1) Prepared ginger: It is pungent and hot in nature, and enters the spleen, stomach and kidney meridians. It has the effects of warming the meridians to stop bleeding, warming the middle and relieving pain. It is often used to treat symptoms such as yang deficiency bleeding, hematemesis, metrorrhagia, spleen and stomach deficiency and cold, abdominal pain, vomiting and diarrhea.

[0024] Prepared ginger is obtained by drying fresh ginger and then processing it with sand. Modern pharmacological studies have shown that prepared ginger contains active substances such as gingerol, shogaol, gingerone, curcumin, gingerene, and curcumin, which play important roles in anti-inflammation, immune regulation, and inhibition of joint tissue damage. 1. Its extracts, shogaol and gingerol derivatives, can reduce the mRNA transcription and protein secretion of TNF-α, IL-1β, and IL-6 by inhibiting the NF-κB, MAPK, and PI3K / Akt signaling pathways; at the same time, they can reduce the activity of COX-2 and LOX, and reduce the production of inflammatory mediators such as PGE2 and LTB4, thereby alleviating synovial congestion, edema, and inflammatory cell infiltration. 2. Gingerol and curcumin derivatives can increase the activity of SOD and GSH-Px, reduce MDA levels, and reduce ROS oxidative damage to joint tissues, indirectly alleviating inflammation. 3. Shogaol can also inhibit the polarization of macrophages towards the "pro-inflammatory M1 phenotype" and promote their transformation towards the "anti-inflammatory M2 phenotype," reducing the release of pro-inflammatory factors. 4. Gingerol-like components can act on peripheral nerve endings to inhibit pain signal transmission (such as reducing the release of pain mediators such as SP and CGRP).

[0025] (2) Cinnamon: It is pungent and sweet in taste, and very hot in nature. It enters the kidney, spleen, heart, and liver meridians. It has the effects of tonifying fire and assisting yang, guiding fire back to its source, dispelling cold and relieving pain, and warming and unblocking the meridians. It is often used for impotence and cold uterus, cold pain in the waist and knees, asthma due to kidney deficiency, floating of deficient yang, dizziness and red eyes, cold pain in the heart and abdomen, vomiting and diarrhea due to deficiency and cold, abdominal pain due to cold hernia, dysmenorrhea and amenorrhea.

[0026] Modern pharmacological studies have shown that cinnamon contains active ingredients such as cinnamaldehyde, cinnamic acid, and cinnamyl alcohol, which play important anti-inflammatory and antioxidant roles. Specifically: 1. Cinnamaldehyde can significantly reduce the mRNA transcription and protein secretion of pro-inflammatory factors by inhibiting NF-κB phosphorylation activation; it also reduces COX-2-mediated PGE2 and iNOS-mediated NO production, thereby alleviating synovial congestion, edema, and the infiltration of inflammatory cells such as neutrophils and macrophages, thus relieving acute joint inflammation. Cinnamaldehyde can also increase plasma levels of glutathione peroxidase and total superoxide dismutase, and decrease malondialdehyde levels, exhibiting significant antioxidant effects. 2. Flavonoids such as cinnamyl glycoside, quercetin, and kaempferol, due to their unique phenolic hydroxyl structures, demonstrate significant antioxidant capabilities in scavenging free radicals and inhibiting lipid peroxidation, effectively alleviating the oxidative stress imbalance in the joints of patients with rheumatoid arthritis.

[0027] (3) Arisaema: It is pungent and bitter in taste, warm in nature, and poisonous. It enters the lung, spleen, and liver meridians. It has the effect of reducing swelling and dissipating nodules. It is often used externally to treat carbuncles, snake and insect bites, and other diseases.

[0028] Modern pharmacological studies have shown that the key active substances in Arisaema heterophyllum are mainly polysaccharide components, among which the neutral homogeneous polysaccharide ARPA has been confirmed as an important material basis for its anti-rheumatoid arthritis effects. 1. Arisaema heterophyllum extract can significantly improve paw swelling and arthritis index in rats with collagen-induced arthritis (CIA), and reduce spleen index; its mechanism is related to the downregulation of serum TNF-α, IL-1β, and IL-6 levels, while upregulating the anti-inflammatory factor IL-10. 2. ARPA can inhibit the degradation of IκB in the NF-κB signaling pathway, block the activation of p65 and the synthesis of inflammatory factors; it also inhibits the phosphorylation of p38 and ERK1 / 2 in the MAPK pathway, thereby exerting an anti-inflammatory effect. 3. ARPA can arrest the T cell line Jurkat in the G2 / M phase, inhibit its proliferation and induce apoptosis; this pathway is related to the activation of Caspase-3 and Caspase-9, and the regulation of Bcl-2 / Bax protein balance, suggesting that it achieves immunomodulation through the mitochondrial apoptosis pathway. 4. In a rat model of arthritis induced by Freund's complete adjuvant (AA), ARPA (20–60 mg / kg) significantly reduced joint swelling, improved histopathological changes, and decreased inflammatory cell infiltration in the synovium. 5. After oral administration, a small amount of ARPA is absorbed into the bloodstream, and it is mainly excreted unchanged in the feces. Studies have shown that it has a certain degree of stability in vivo, but the processing method causes a loss of approximately 28% of the ARPA content.

[0029] (4) Red peony root: It tastes bitter and is slightly cold in nature. It enters the liver meridian. It has the effects of clearing heat and cooling blood, dispersing blood stasis and relieving pain. It is often used for diseases such as heat entering the blood, febrile rashes, hematemesis and epistaxis, red and swollen eyes, liver stagnation and hypochondriac pain, amenorrhea and dysmenorrhea, abdominal masses and pain, traumatic injuries, carbuncles and sores.

[0030] Modern pharmacology shows that the key active substances in Paeonia lactiflora are primarily paeoniflorin glycosides, followed by flavonoids and tannins, which work synergistically to exert anti-inflammatory, immunomodulatory, joint tissue damage-inhibiting, and blood circulation-improving effects. 1. Total paeoniflorin glycosides improve blood circulation by inhibiting PLT aggregation, enhancing erythrocyte deformability, reducing blood viscosity, and prolonging thrombus formation time. 2. Paeoniflorin glycosides, paeoniflorin B, paeoniflorin C, and paeoniflorin dione significantly inhibit NO production, exhibiting good anti-inflammatory activity. 3. Studies have also shown that Paeonia lactiflora polysaccharides exhibit strong hydroxyl radical scavenging and superoxide anion radical scavenging abilities, as well as strong total reducing power, i.e., antioxidant capacity, which can reduce oxidative stress damage to joint tissues.

[0031] (5) Angelica dahurica: It is pungent and warm in nature, and enters the stomach, large intestine and lung meridians. It has the effects of relieving exterior syndromes and dispelling cold, dispelling wind and relieving pain, clearing nasal passages, drying dampness and stopping leukorrhea, and reducing swelling and draining pus. It is often used for colds with headache, supraorbital neuralgia, nasal congestion and runny nose, rhinitis, sinusitis, toothache, leukorrhea, sores and swelling.

[0032] Modern pharmacological studies have shown that the key active substances of Angelica dahurica are centered around coumarins, namely imperatorin, isoimperatorin, oxypeucedanin, etc. Other volatile oils and polysaccharides work together with coumarins to exert anti-inflammatory, immunomodulatory, and analgesic effects. 1. Studies have shown that tetradecanol and 2-methyl-2-hexanol in the volatile oil of Angelica dahurica are the key components for its anti-inflammatory and analgesic effects. The volatile oil contains 20 lipid compounds, which can weaken the secretion of related inflammatory factors such as IL-1, IL-6, TNF-α, and IL-8 by macrophages. In addition, the aldehyde and ketone compounds in the volatile oil mainly include lauric aldehyde, which is the core key component for the development of antipyretic, anti-inflammatory, and analgesic drugs. 2. Studies have shown that the coumarins of Angelica dahurica mainly exert their antioxidant effects by scavenging free radicals. The furanocoumarins in its coumarins regulate the metabolic pathway of arachidonic acid in the body by inhibiting cyclooxygenase-2 to achieve the purpose of anti-inflammation. The analgesic effects of coumarin components imperatorin and isoimperatorin have also been widely confirmed by many studies.

[0033] (6) Aconitum kusnezoffii Reichb.: Pungent and bitter in taste, hot in nature; highly toxic, entering the heart, liver, kidney, and spleen meridians. It has the effects of dispelling wind and dampness, warming the meridians and relieving pain. It is commonly used in the treatment of wind-cold-dampness arthralgia, joint pain, abdominal cold pain, cold hernia pain, and anesthesia for pain relief and other diseases.

[0034] Modern pharmacological studies have shown that the main pharmacological activities of Aconitum kusnezoffii Reichb. mainly stem from its diterpenoid alkaloids (the main components include aconitine, hypaconitine, and mesaconitine), which participate in the anti-inflammatory and immune regulation processes. Other components such as polysaccharides and flavonoids have relatively low contents and can assist in enhancing the anti-inflammatory effect. 1. Studies have shown that aconitine and hypaconitine can reduce the phosphorylation and nuclear translocation of the NF-κBp65 subunit, decrease the mRNA transcription and protein secretion of pro-inflammatory factors; at the same time, reduce the COX-2 activity and decrease the production of PGE2, thereby reducing synovial congestion, edema, and inflammatory cell infiltration, and relieving joint swelling, redness, and burning sensation. 2. Aconitine can cross the blood-brain barrier, act on the opioid receptors in the central nervous system, enhance the effects of analgesic substances such as endorphins, and at the same time inhibit the excessive excitability of spinal dorsal horn neurons, significantly increasing the body's tolerance threshold to chronic pain, and having a strong relieving effect on rheumatoid intractable joint pain. 3. Hypaconitine in Aconitum kusnezoffii Reichb. can slightly inhibit the proliferation and differentiation of B cells, reduce the production of plasma cells, thereby decreasing the levels of rheumatoid arthritis characteristic autoantibodies such as ACPA and RF in the serum, and reducing the damage of synovium caused by the deposition of immune complexes.

[0035] (7) Raw Olibanum: Pungent and bitter in taste, warm in nature, entering the heart, liver, and spleen meridians. It has the effects of promoting blood circulation to stop pain, reducing swelling and promoting granulation. It is commonly used in the treatment of chest pain, epigastric pain, dysmenorrhea and amenorrhea, postpartum blood stasis, abdominal pain due to mass, rheumatic arthralgia, muscle contracture, traumatic injury, carbuncle and ulcer, etc.

[0036] Modern pharmacological studies have shown that the key active substances in raw frankincense are primarily resinous components (mainly frankincense acids), supplemented by volatile oils and gums for synergistic effects. 1. Literature indicates that frankincense acid-25 can inhibit LPS-induced production of NO, PGE2, and ROS in macrophages, while downregulating the expression of iNOS and COX-2, thereby alleviating inflammatory responses. Animal experiments have found that frankincense acid-25 can also inhibit lipopolysaccharide-induced activation of the NF-κB / i-κBα signaling pathway and inhibit carrageenan-induced paw edema in Balb / c mice. 2. AKA in raw frankincense is a specific inhibitor of 5-LOX, directly binding to the 5-LOX active site and blocking its catalytic conversion of arachidonic acid to leukotrienes, reducing the production of pro-inflammatory mediators such as LTB4. This mechanism differs from the COX inhibition pathway of NSAIDs, thus avoiding COX inhibition-related gastrointestinal side effects. 3. Literature shows that in vitro experiments have confirmed that AKBA can reduce the mRNA and protein levels of MMPs in synovial cells and chondrocytes by inhibiting the NF-κB and MAPK pathways, while upregulating the expression of cartilage matrix synthesis-related factors, reducing cartilage matrix degradation, and delaying the process of cartilage damage.

[0037] (8) Raw myrrh: It is pungent and bitter in taste, neutral in nature, and enters the heart, liver, and spleen meridians. It has the effects of dispersing blood stasis, relieving pain, reducing swelling, and promoting tissue regeneration. It is often used for chest pain, stomach pain, dysmenorrhea, amenorrhea, postpartum blood stasis, abdominal pain due to masses, rheumatic pain, traumatic injuries, carbuncles, sores, and other diseases.

[0038] Modern pharmacological studies have shown that the key active substances in raw myrrh are mainly resinous compounds (biazines, furanosesquiterpenes, and triterpenoids) and volatile oils. These components work synergistically to exert their medicinal effects. 1. α-Bisabolic acid in raw myrrh can simultaneously inhibit the activity of COX-2 and 5-LOX, significantly reducing the production of PGE2 and LTB4. This "dual-enzyme inhibition" mechanism makes its anti-inflammatory effect more comprehensive and its safety higher. 2. Network pharmacology shows that when myrrh is combined with frankincense, 16 active components are identified, resulting in 468 targets related to rheumatoid arthritis, 320 potential targets, and 62 overlapping targets. These targets act on multiple pathways, including IL6, IL1B, TNF, and MAPK1, primarily involving TNF and Toll-like receptors. Animal experiments showed that the combination of myrrh and frankincense reduced the expression of CD31 and collagen IV, increased the coverage of perivascular cells in inflammatory exudates, and strengthened intercellular connections. The two may exert anti-inflammatory and analgesic effects by regulating hypoxia response and neurovascular related pathological processes and pathways.

[0039] (9) Gallnut: It tastes sour and astringent, and is cold in nature. It enters the lung, large intestine, and kidney meridians. It has the effects of astringing the lungs and reducing fire, astringing the intestines and stopping diarrhea, astringing sweat, stopping bleeding, and astringing dampness and healing sores. It is often used for chronic cough due to lung deficiency, cough with phlegm due to lung heat, chronic diarrhea and dysentery, spontaneous sweating and night sweats, diabetes, hematochezia and hemorrhoidal bleeding, external bleeding, carbuncles and boils, and skin rot.

[0040] Modern pharmacological studies have shown that the key active substances in gallnut are mainly tannins, supplemented by flavonoids and polyphenols for synergistic effects. 1. Tannins can significantly reduce the levels of pro-inflammatory cytokines IL-1 and IL-6 in serum and tissues, while simultaneously increasing the protein levels of basic fibroblast growth factor, extracellular signal-regulated kinase 1 / 2, and p-ERK1 / 2 in the ERK1 / 2 pathway, thereby addressing damage. 2. Ellagic acid in gallnut can significantly enhance the activities of catalase, glutathione peroxidase, superoxide dismutase, and total antioxidant enzymes in D-galactose-induced aging rats, and can scavenge free radicals to restore the antioxidant defense system, improving the oxidative stress imbalance in rheumatoid arthritis.

[0041] (10) White mustard seed: It is pungent and warm in nature, and enters the lung meridian. It has the effects of warming the lungs, clearing phlegm and promoting qi circulation, dispersing nodules, unblocking the meridians and relieving pain. It is often used for cold phlegm cough, chest and rib pain, phlegm stagnation in the meridians, joint numbness and pain, phlegm and dampness flow, carbuncles and boils.

[0042] Modern pharmacological studies have shown that the core active substances in white mustard seed are mainly sinigrin, glucosinolates, and their hydrolysis product isothiocyanates. 1. White mustard seed alcohol extract significantly inhibited xylene-induced ear swelling and acetic acid-induced increase in capillary permeability in mice, and prolonged the pain response time and reduced the number of writhing episodes in mice, confirming that white mustard seed has strong anti-inflammatory and analgesic effects. 2. In rheumatoid arthritis, Bax and Bcl-2 expression are abnormal in fibroblast-like synovial cells. White mustard seed extract can inhibit the expression of PCNA and Bcl-2 proteins and promote Bax protein expression, thereby inhibiting the proliferation of rheumatoid arthritis-FLS cells and inducing apoptosis, thus improving the condition. 3. White mustard seed can exert its effects by inhibiting the TLR4 / NF-κB inflammatory axis.

[0043] The compatibility analysis of the traditional Chinese medicine composition of the present invention is as follows: This formula adopts the principle of "principal, assistant, adjuvant, and guide" in its formulation, mainly treating "rheumatoid arthritis of the wind-cold-dampness obstruction type" by warming the meridians and dispelling cold, eliminating wind and dampness, promoting blood circulation and removing blood stasis, and reducing swelling and relieving pain. This syndrome is mostly caused by the invasion of wind, cold, and dampness, which obstructs the meridians and hinders the flow of qi and blood. Therefore, the formula focuses on dispelling wind and cold, drying dampness and resolving phlegm, promoting blood circulation and relieving pain, so as to relieve numbness, unblock the meridians, and restore joint function.

[0044] The specific compatibility analysis is as follows: Chief herb: Aconitum carmichaelii. Aconitum carmichaelii is pungent, hot, and toxic. It is good at dispelling wind and dampness, dispersing cold and relieving pain. It is specifically used to treat joint pain and stiffness caused by cold and dampness. Its penetrating nature allows it to directly reach the affected area. It is the main herb for treating joint pain caused by wind, cold, and dampness. It governs the entire formula and exerts a strong effect in dispelling cold and relieving pain.

[0045] Assistant herbs: Prepared ginger, cinnamon, arisaema, white mustard seed, and angelica dahurica. Prepared ginger, being pungent and hot, enters the meridians, warming the meridians, dispelling cold, and assisting yang to unblock the channels; cinnamon warms the meridians, relieves pain, and guides fire back to its source, assisting aconite in enhancing its effects of dispelling cold and relieving pain. Arisaema dries dampness, resolves phlegm, dispels wind, and relieves spasms, specifically treating obstruction caused by phlegm and dampness accumulation; white mustard seed warms the lungs, resolves phlegm, disperses nodules, and relieves pain, especially suitable for joint stiffness due to cold-dampness and phlegm obstruction. Angelica dahurica dispels wind and dampness, unblocks the channels, and relieves pain, reaching both the exterior and interior, enhancing its ability to expel pathogens. These assistant herbs work together to assist the principal herb in dispelling wind and cold, drying dampness, and resolving phlegm, thus eliminating pathogens and unblocking the joints.

[0046] Adjuvant herbs: Red peony root, raw frankincense, and raw myrrh. Red peony root, bitter and cold in nature, enters the blood, invigorates blood circulation, removes blood stasis, clears heat, and relieves pain. It can alleviate joint swelling and the subtle signs of heat, while also counteracting the excessive spiciness of other hot and pungent herbs. Frankincense and myrrh promote qi and blood circulation, reduce swelling, and relieve pain. They complement red peony root, working together to improve local blood stasis, swelling, and stiffness. The addition of these adjuvant herbs allows the entire formula to dispel cold and dampness while simultaneously invigorating blood circulation and removing blood stasis, achieving a comprehensive treatment effect.

[0047] The guiding herb is gallnut. Gallnut has astringent and consolidating properties, making it easier for the medicine to remain on the affected area when applied topically, thus prolonging its effect. It also has a certain effect of reducing swelling and healing sores, acting as a guide for the medicine to be applied and harmonizing the effects of other herbs.

[0048] The formula of this invention uses Aconitum carmichaelii as the chief ingredient to dispel wind and cold, directly targeting the root cause of obstruction. It is supplemented with prepared ginger, cinnamon, Arisaema heterophyllum, white mustard seed, and Angelica dahurica as assistant ingredients to synergistically dispel wind and dampness, dispel cold and eliminate phlegm, and enhance the analgesic effect. It is further supplemented with Paeonia lactiflora, frankincense, and myrrh to invigorate blood circulation, remove blood stasis, reduce swelling and relieve pain, moderate the pungent and hot properties of the herbs, and improve local blood flow. The guiding ingredient, Galla chinensis, consolidates the effects of the medicine, prolongs its efficacy, and guides the medicine directly to the affected area. The entire formula works synergistically to dispel wind and cold, dry dampness and resolve phlegm, invigorate blood circulation, and relieve pain. It is suitable for rheumatoid arthritis caused by wind-cold-dampness obstruction, cold pain in the joints, and difficulty in flexion and extension, effectively relieving pain and improving joint function.

[0049] Compared with the prior art, the present invention has the following technical advantages: (1) The traditional Chinese medicine composition of the present invention has a reasonable compatibility relationship, and its functions are interconnected and work together to exert their effects. It can warm the meridians and dispel cold, dispel wind and eliminate dampness, directly reach the disease site to relieve pain, and also promote blood circulation, remove blood stasis, unblock the meridians and reduce swelling, so that the joints can flow smoothly and the tendons and bones can be nourished. The combination of the medicines can treat both the symptoms and the root cause. Clinical practice shows that the external application of the medicine of the present invention has an effectiveness rate of nearly 90% in improving rheumatoid arthritis of the wind-cold-dampness type. It can significantly relieve joint pain and stiffness, improve joint function, has high safety, no obvious toxic side effects, low recurrence rate, short course of treatment, good patient compliance, significant clinical application value, and good social and economic benefits.

[0050] (2) This invention uses an external application method of drug delivery, avoiding the systemic toxicity of oral medications such as aconite and arisaema. Through transdermal absorption, the drug directly reaches the affected area, resulting in high local drug concentration, rapid onset of action, and definite analgesic effect. Furthermore, the external application formula of this invention emphasizes "warming and dispersing cold, promoting blood circulation and removing blood stasis, and anti-inflammatory and analgesic effects" as its main principles. The medicinal properties are mild, safe, and controllable, making it suitable for long-term external treatment of chronic rheumatoid arthritis of the wind-cold-dampness type, which is in line with the development trend of modern Chinese medicine external patches.

[0051] (3) This invention uses only external application as the method of drug delivery, which is simple to operate, has good patient compliance, and can be used in a standardized manner in a home or outpatient setting for a long time. It does not need to be combined with internal methods such as medicinal wine, and will not increase the burden on the liver and kidneys, thus having a high safety profile.

[0052] (4) The external application formula of the present invention is more scientific in its formulation design. It uses rice wine as a medium to gently enhance the penetration of the drug effect and can greatly reduce skin irritation compared with ethanol-extracted tinctures. Detailed Implementation

[0053] The present invention will now be described in detail with reference to specific embodiments. These embodiments are based on the technical solution of the present invention and provide detailed implementation methods and specific operating procedures. However, the scope of protection of the present invention is not limited to the following embodiments.

[0054] Unless otherwise specified, the reagents, methods, instruments, and equipment used in this invention are conventional in the art. Unless otherwise specified, the reagents and materials used in the following examples are all commercially available.

[0055] All the Chinese medicinal materials used in this invention were provided by the Chinese Pharmacy of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, affiliated with Shanghai University of Traditional Chinese Medicine.

[0056] Example 1: This embodiment provides a traditional Chinese medicine composition and application for treating rheumatoid arthritis of the wind-cold-dampness type. The specific technical solution is as follows: (1) Preparation of medicinal materials: Weigh out the following ingredients in the specified proportions: 90 g of prepared ginger, 15 g of cinnamon, 30 g of arisaema, 90 g of red peony root, 30 g of angelica root, 90 g of aconite root, 9 g of raw frankincense, 5 g of raw myrrh, 9 g of gallnut, and 9 g of white mustard seed. Remove impurities, rinse briefly with purified water, and dry at low temperature for later use.

[0057] (2) Grinding and sieving: First, coarsely grind the hard medicinal materials such as Aconitum carmichaelii, Arisaema heterophyllum, and Galla chinensis, then finely grind them. Then grind the medium-hardness medicinal materials such as Paeonia lactiflora, Angelica dahurica, and Zingiber officinale. Add the volatile oils or resins containing medicinal materials such as Cinnamomum cassia, Sinapis alba, Boswellia carterii, and Commiphora myrrha later, and grind them briefly at a low temperature to reduce aroma loss and adhesion.

[0058] Combine all the above raw material powders, mix well, and pass through a 100-mesh sieve to obtain a uniform fine powder.

[0059] (3) Prepare the paste: Take the prepared fine powder and add about 1.1 mL of rice wine to 1 g of powder. Gradually add warm rice wine at about 35 °C while stirring, until a thick paste is formed with a uniform texture that does not flow.

[0060] (4) Spreading: The obtained paste is evenly spread on a non-woven fabric carrier to a thickness of 2-3 mm, and then cut into patches that cover the lesion and extend 1-2 cm beyond the edge.

[0061] (5) External application procedure: Apply the medicine to the skin, avoiding adhesion to body hair, and cover with a layer of dry gauze to secure it.

[0062] For the first time, it is recommended to observe tolerance for 1-2 hours; if only a warm and slightly red feeling is observed, the interval can be gradually extended to 4-8 hours per treatment. If unbearable burning pain, severe itching, or blisters occur, the affected area should be removed immediately and the area washed with warm water.

[0063] (6) Dosage and frequency: For each joint, use 8-15 g of powder (upper limit for large joints, lower limit for small joints).

[0064] Apply once daily. For severe symptoms and good tolerance, it can be applied twice a day for short periods (e.g., 2-4 hours each time), but the total daily application time should not exceed 8 hours.

[0065] (7) Storage: The finished powder should be stored in a sealed, light-proof, and dry container for one month. Once prepared into a paste, it should be used immediately and should not be refrigerated for more than 24 hours.

[0066] Example 2: This embodiment provides a traditional Chinese medicine composition and application for treating rheumatoid arthritis of the wind-cold-dampness type. The difference from Embodiment 1 is that the dosage of each component of the traditional Chinese medicine composition in this embodiment is as follows: 88 parts of dried ginger, 14 parts of cinnamon, 31 parts of arisaema, 87 parts of red peony root, 28 parts of angelica dahurica, 92 parts of aconite, 10 parts of raw frankincense, 5 parts of raw myrrh, 8 parts of gallnut, and 10 parts of white mustard seed.

[0067] Example 3: This embodiment provides a traditional Chinese medicine composition and application for treating rheumatoid arthritis of the wind-cold-dampness type. The difference from Embodiment 1 is that the dosage of each component of the traditional Chinese medicine composition in this embodiment is as follows: 93 parts of dried ginger, 17 parts of cinnamon, 29 parts of arisaema, 92 parts of red peony root, 32 parts of angelica dahurica, 89 parts of aconite, 8 parts of raw frankincense, 6 parts of raw myrrh, 10 parts of gallnut, and 7 parts of white mustard seed.

[0068] Clinical efficacy verification: Taking the traditional Chinese medicine composition of Example 1 as an example, the present invention recruited volunteers to conduct experiments and achieved good clinical treatment results.

[0069] I. Diagnostic criteria for rheumatoid arthritis of the wind-cold-dampness obstruction type (1) Clinical manifestations Rheumatoid arthritis of the wind-cold-dampness type refers to joint swelling and pain caused by external wind-cold-dampness pathogens obstructing the meridians and joints, leading to poor blood and qi circulation. It is commonly seen in individuals who have been exposed to cold and damp environments for a long time, those with weak constitutions, or those with insufficient yang qi. Its main clinical manifestations include: joint swelling and pain, fixed location of pain, significant morning stiffness, difficulty in flexion and extension, severe pain upon exposure to cold, local aversion to cold, and limited joint movement. It may be accompanied by general chills, cold extremities, and fatigue. The tongue coating is thin and white, and the pulse is often floating and tight or deep and tight. The course of the disease is often chronic, protracted, and recurrent, with symptoms significantly aggravated by cold-dampness invasion. It can be diagnosed after ruling out other rheumatic and autoimmune diseases.

[0070] (2) Auxiliary examinations Laboratory tests: Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and rheumatoid factor (RF) may be mildly to moderately elevated; anti-CCP antibody is positive.

[0071] Imaging examinations: X-ray and MRI may show soft tissue swelling of the joint, with no obvious bone destruction in the early stage; some cases may show joint space narrowing or mild osteoporosis.

[0072] Ultrasound examination: Small amount of fluid in the joint cavity or mild thickening of the synovium.

[0073] Traditional Chinese medicine diagnostic examination: Combine tongue and pulse characteristics (thin white tongue coating, floating and tight or deep and tight pulse) for diagnostic reference.

[0074] (3) Classification criteria Based on joint symptoms, impact on daily function, and objective examination findings, rheumatoid arthritis of the wind-cold-dampness type is classified into three categories: mild, moderate, and severe. Mild (Grade I): Mild joint pain, mainly occurring after exposure to cold or exertion; short duration of morning stiffness; minimal impact on daily activities. Physical examination reveals mild local tenderness, and the range of motion of the joint is basically normal.

[0075] Moderate (Grade II): Joint pain is more pronounced, morning stiffness is prolonged (>30 minutes), relief after activity is not significant, and symptoms are significantly aggravated by cold and damp weather. Daily life and work are limited, and physical examination of the joints reveals significant tenderness and mild to moderate range of motion impairment.

[0076] Severe (Grade III): Persistent joint pain, often intense, may be accompanied by pulling or stabbing pain; prolonged morning stiffness (>60 minutes), significantly limited joint movement, and severely reduced quality of life. Physical examination reveals joint swelling, stiffness, and significant limitation of movement; patients often require medication for relief.

[0077] (4) Inclusion criteria Those who meet all of the following criteria can be included in the study: The patient meets the diagnostic criteria for rheumatoid arthritis, and according to traditional Chinese medicine, the condition is classified as wind-cold-dampness obstruction type.

[0078] The main symptoms are joint swelling and pain, which worsens with cold, and morning stiffness and difficulty in bending and stretching.

[0079] Age 18-65, gender not limited.

[0080] The patient is conscious, cooperative with treatment and follow-up, and has independent judgment.

[0081] Participants voluntarily participate in this study and sign an informed consent form.

[0082] (5) Exclusion criteria Individuals meeting any of the following criteria shall not be included in the study: It may be accompanied by other rheumatic diseases (such as systemic lupus erythematosus, ankylosing spondylitis, gout, etc.).

[0083] Individuals with serious diseases or dysfunction of vital organs such as the heart, brain, liver, and kidneys.

[0084] Pregnant or breastfeeding women, or those planning to become pregnant in the near future.

[0085] People with mental disorders or cognitive impairment.

[0086] Those who are allergic to the medication or related ingredients used.

[0087] (6) Standards for shedding and rejection During treatment and research, cases should be excluded or treated as dropouts if any of the following conditions are met: Patients who experience severe adverse reactions during treatment and are unable to continue treatment.

[0088] Those who fail to take medication according to the prescribed regimen, have poor adherence, and whose treatment efficacy is affected.

[0089] Researchers who withdraw midway or request to withdraw.

[0090] For those whose original data is incomplete and whose treatment efficacy cannot be assessed.

[0091] II. Treatment Plan Apply this compound powder externally (composed of prepared ginger, cinnamon, jackinthepulpit tuber, red peony root, dahurian angelica root, kusnezoff monkshood, raw frankincense, raw myrrh, Chinese gall, and white mustard seed in compatibility), once a day. Mix it with warm rice wine in proportion to make a medicinal paste, evenly spread it on a gauze or non-woven fabric with a thickness of 2 - 3 mm, apply it to the affected joint and fix it. Observe the tolerance for 1 - 2 hours during the first external application. If there is only mild warmth and slight redness, the application time can be gradually extended to 4 - 8 hours each time. For those with severe symptoms and good tolerance, it can be applied briefly twice a day (such as 2 - 4 hours each) during the day and at night, but the total daily application time does not exceed 8 hours. For each single joint, use 8 - 15 g of the medicinal powder each time (take the upper limit for large joints and the lower limit for small joints). 7 days is one treatment course. Observe the skin reaction after a 2 - 3 - day interval between courses and then continue the treatment. After 4 consecutive treatment courses, the curative effect is statistically analyzed (in actual clinical treatment, some patients with milder conditions can show obvious effects or even be cured after 1 - 2 treatment courses, but the final curative effect statistics are still calculated based on 4 treatment courses).

[0092] III. Curative Effect Evaluation Criteria (1) Cured: The symptoms of joint swelling, pain, and tenderness disappear, morning stiffness is relieved, and the joint movement function returns to normal; Laboratory indicators (RF, ESR, CRP) return to normal; Imaging examinations (X-ray / ultrasound / MRI) show no new bone destruction in the joint and the synovitis subsides; Functional score: DAS28 ≤ 2.6 (clinical remission); Functional disability index: HAQ-DI ≤ 0.5 (close to no disability); No recurrence after 4 - month follow-up.

[0093] (2) Markedly effective: The symptoms of joint swelling, pain, and tenderness are significantly relieved (≥50%), and the morning stiffness time is shortened by ≥50%; Laboratory indicators are significantly improved (RF, ESR, CRP decrease by ≥50%); Imaging examinations (X-ray / ultrasound / MRI) show no new bone destruction in the joint and the synovitis is significantly improved; Functional score: 2.6 < DAS28 ≤ 3.2 (mild activity); Functional disability index: 0.5 < HAQ-DI ≤ 1.0 (mild functional impairment).

[0094] (3) Effective: The symptoms of joint swelling, pain, and tenderness are somewhat alleviated (<50%), and the improvement of morning stiffness is not obvious; Laboratory indicators are partially improved (RF, ESR, CRP decrease by <50%); In imaging examinations (X-ray / ultrasound / MRI), the progression of joint bone destruction is limited or basically stable, and the improvement of synovitis is not obvious; Functional score: 3.2 < DAS28 ≤ 5.1 (moderate activity); Functional disability index: 1.0 < HAQ-DI ≤ 2.0 (moderate functional impairment).

[0095] (4) Ineffective: There is no obvious improvement in joint symptoms and laboratory indicators, or the condition worsens, and new joint deformities appear; Imaging examinations (X-ray / ultrasound / MRI) show aggravated bone destruction or joint space stenosis; Functional score: DAS28 > 5.1 (high activity); Functional disability index: HAQ-DI > 2.0 (severe functional impairment), and other medications need to be replaced for treatment.

[0096] IV. Statistical analysis In this study, a total of 220 rheumatoid arthritis patients were included and treated with the external application of the traditional Chinese medicine composition of the present invention.

[0097] After statistical analysis of the treatment results, it was shown that: (1) As shown in Table 1, there were 24 cured patients, 92 markedly effective patients, 81 effective patients, and 23 ineffective patients, and the total effective rate was 89.5%. No obvious adverse reactions were observed during the treatment process, and most patients had stable symptoms and stable emotions within 4 months of follow-up, without serious recurrence.

[0098] Table 1 Comparison of curative effects Cases (%) (2) As shown in Table 2, in the laboratory index examinations of 220 patients, the average value of rheumatoid factor (RF) before treatment was 99.3 ± 7.5 U / mL, which was significantly reduced to 26.9 ± 4.3 U / mL after treatment; the average value of erythrocyte sedimentation rate (ESR) before treatment was 45.9 ± 6.1 U / mL, which was significantly reduced to 16.5 ± 2.9 after treatment; the average value of C-reactive protein before treatment was 37.1 ± 12.3 U / mL, which was significantly reduced to 6.7 ± 2.2 U / mL after treatment.

[0099] Table 2 Comparison of laboratory indicators ( ±s) Compared with before treatment in this group, *P < 0.05.

[0100] (3) As shown in Table 3, the DAS28 score decreased significantly from 4.5±0.5 to 1.1±0.1 after treatment, which is much less than 2.6, indicating that most patients achieved clinical remission.

[0101] Table 3 Comparison of DAS28 scores before and after treatment ( ±s) Compared with the pre-treatment values ​​in this group, *P<0.05.

[0102] (4) As shown in Table 4, the HAQ-DI functional disability index decreased significantly from 1.8±0.6 to 0.6±0.5 after treatment, indicating that most patients achieved clinical remission.

[0103] Table 4 Comparison of HAQ-DI Functional Disability Index scores before and after treatment ( ±s) Compared with the pre-treatment values ​​in this group, *P<0.05.

[0104] V. Classic Cases 1. Mr. Wang, male, 55 years old, from Nanjing City, Jiangsu Province, was diagnosed with rheumatoid arthritis with a disease course of 12 years. Twelve years ago, the patient experienced pain in both knees and ankles, which worsened with cold exposure, and morning stiffness lasting about 40 minutes, relieved only after activity. For the past six months, his knee flexion and extension had become significantly limited. His tongue was pale red with a thick white coating, and his pulse was deep and tight. After two courses of treatment with the combination of drugs from this invention, his knee pain decreased and his range of motion increased. After four courses of treatment, he was able to walk and climb stairs normally. During a four-month follow-up, the joint swelling and pain did not recur.

[0105] 2. Ms. Zhao, female, 58 years old, from Wuhan City, Hubei Province, was diagnosed with rheumatoid arthritis with a disease course of 8 years. The patient experienced recurrent swelling and pain in her finger joints, accompanied by cold limbs, morning stiffness lasting about 30 minutes, and symptoms worsening in cold weather. Her tongue was pale with a thin white coating, and her pulse was floating and tight. After treatment with the combination of drugs of this invention, the swelling of her finger joints was significantly reduced after one course of treatment, and the morning stiffness basically disappeared after two courses. During a 4-month follow-up, her symptoms remained stable, and her quality of life improved.

[0106] 3. Ms. Liu, female, 62 years old, from Hongkou District, Shanghai, was diagnosed with rheumatoid arthritis with a 20-year disease course. Twenty years ago, she experienced pain in both hand joints, which gradually spread to the wrist joints. In the past three years, morning stiffness had become prolonged, and joint mobility had significantly decreased. Her tongue was pale red with a thin white coating, and her pulse was wiry and thready. After treatment with the combination of drugs of this invention, her joint pain was significantly relieved after one course of treatment, her mobility returned to normal after three courses, and she achieved clinical cure after four courses. During a four-month follow-up, her symptoms disappeared, and no recurrence was observed.

[0107] Rheumatoid arthritis is a common chronic and progressive disease in clinical practice. Western medicine considers it primarily caused by autoimmune abnormalities, manifesting as inflammatory reactions of the synovial membrane, pannus formation, and cartilage and bone destruction, ultimately leading to joint deformities and functional impairment, often accompanied by morning stiffness, joint pain, swelling, and limited mobility. Traditional Chinese medicine classifies it under the categories of "Bi syndrome" and "Li Jie," believing it is mostly caused by the invasion of wind, cold, and dampness, leading to obstruction of the meridians and poor circulation of Qi and blood. Patients often have insufficient constitution, deficient vital energy, and weak pores, making them susceptible to external wind, cold, and dampness. These pathogens remain in the joints, causing obstruction, stagnation of Qi and blood, and malnourishment of the tendons and vessels. Prolonged illness penetrates the meridians, causing phlegm and blood stasis, further obstructing the meridians, exacerbating pain, joint stiffness, and even deformities. If wind, cold, and dampness persist, they damage Yang Qi over time. Yang deficiency prevents the transformation of Qi and blood, resulting in prolonged joint pain that is difficult to cure. Clinically, the general principle is to eliminate pathogens and strengthen the body's resistance. It is necessary to differentiate between deficiency and excess syndromes and to use drugs in a reasonable combination.

[0108] Based on this, the present invention employs a topical application method of drug delivery, avoiding the systemic toxicity and side effects of oral administration of drugs such as aconite and arisaema. Through transdermal absorption, the drug directly reaches the affected area, resulting in high local drug concentration, rapid onset of action, and definite analgesic effect. Furthermore, the topical application is simple to use, has good patient compliance, and can be used regularly and consistently at home or in outpatient settings without increasing the burden on the liver and kidneys, demonstrating high safety.

[0109] This invention employs a rational combination of principal, assistant, and adjuvant herbs, whose functions are interconnected and work synergistically. It warms the meridians, dispels cold and dampness, directly relieving pain at the site of the disease; it also invigorates blood circulation, removes blood stasis, clears the channels, and reduces swelling, ensuring smooth flow of qi and blood in the joints and nourishing the muscles and bones. The combined herbs treat both the symptoms and the root cause. Clinical practice shows that the efficacy rate of this invention is as high as 89.5%, significantly relieving joint pain and stiffness, improving joint function, with high safety, no obvious toxic side effects, low recurrence rate, short treatment course, and good patient compliance. This invention has significant innovative advantages in the treatment of rheumatoid arthritis of the wind-cold-dampness obstruction type, with definite curative effect, significant clinical application value, and good social and economic benefits.

[0110] The above description of the embodiments is provided to enable those skilled in the art to understand and use the invention. It will be apparent to those skilled in the art that various modifications can be made to these embodiments, and the general principles described herein can be applied to other embodiments without inventive effort. Therefore, the present invention is not limited to the above embodiments, and any improvements and modifications made by those skilled in the art based on the disclosure of the present invention without departing from the scope of the invention should be within the protection scope of the present invention.

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 parts by weight: Prepared ginger 85-95 parts, cinnamon 12-18 parts, arisaema 25-35 parts, red peony root 85-95 parts, angelica root 25-35 parts, aconite root 85-95 parts, raw frankincense 7-11 parts, raw myrrh 4-6 parts, gallnut 7-11 parts, white mustard seed 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 parts by weight: Prepared ginger 87-93 parts, cinnamon 14-16 parts, arisaema 28-32 parts, red peony root 87-93 parts, angelica root 28-32 parts, aconite root 87-93 parts, raw frankincense 8-10 parts, raw myrrh 4-6 parts, gallnut 8-10 parts, white mustard seed 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 parts by weight: Prepared ginger 90 parts, cinnamon 15 parts, arisaema 30 parts, red peony root 90 parts, angelica root 30 parts, aconite root 90 parts, raw frankincense 9 parts, raw myrrh 5 parts, gallnut 9 parts, white mustard seed 9 parts.

4. A dressing, characterized in that, The active ingredient is the traditional Chinese medicine composition for treating rheumatoid arthritis of the wind-cold-dampness type as described in any one of claims 1-3; The patch consists of a patch carrier and a medicated paste layer uniformly coated on the patch carrier, wherein the medicated paste layer is prepared by mixing traditional Chinese medicine powder and rice wine.

5. A dressing according to claim 4, characterized in that, The dressing carrier is gauze or non-woven fabric, and the dressing carrier covers the lesion. The thickness of the paste layer is 2-3 mm.

6. The dressing according to claim 4, characterized in that, The dosage of the herbal composition powder is 8-15 g per joint.

7. The dressing according to claim 4, characterized in that, The dosage relationship between the herbal medicine powder and rice wine is 1 g powder to 1.0-1.2 mL rice wine.

8. A method for preparing the dressing according to claim 4, characterized in that, The preparation method includes the following steps: S1. Preparation of medicinal materials: Wash and dry all kinds of medicinal materials for later use; S2. Grinding and sieving: Grind and mix all kinds of medicinal materials evenly, and then sieve them for later use; S3. Prepare the paste: Mix the fine powder obtained after sun exposure with rice wine in a certain proportion to form a thick paste. S4. Spreading: The obtained paste is evenly spread onto the dressing carrier to obtain the dressing.

9. The method for preparing the dressing according to claim 8, characterized in that, In step S2, the grinding and sieving specifically refers to passing the material through an 80-100 mesh sieve.

10. The method for preparing the dressing according to claim 8, characterized in that, In step S3, the temperature of the rice wine is 35~45 ℃.

Images