Traditional Chinese medicine composition for treating rheumatic arthritis pain

Abstract

The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 20-30 parts of poria cocos, 18-22 parts of lysimachia christinae hance, 5-10 parts of radix aconiti carmichaeli, 10-20 parts of cassia twig, 20-30 parts of rhizoma atractylodis macrocephalae stir-fried with bran and the like, and has the effects of inducing diuresis, removing dampness, warming yang, dispelling cold, invigorating the spleen, removing dampness, reducing phlegm, expelling fluid retention, reinforcing qi, nourishing blood, invigorating the spleen, nourishing the stomach, promoting blood circulation, removing blood stasis, dispelling wind, clearing heat, soothing the liver, regulating qi and the like. The invention also discloses a preparation method of the traditional Chinese medicine composition for treating cold-dampness arthralgia syndrome type rheumatoid arthritis.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating rheumatoid arthritis pain and a preparation method thereof, which are used for treating rheumatoid arthritis pain. Background Art

[0002] Rheumatoid arthritis is a systemic autoimmune disease characterized by chronic joint inflammation. It is an inflammatory, progressive, symmetrical, and destructive joint disease characterized by morning stiffness, pain, swelling, and dysfunction. Mild cases can affect joint function, while severe cases can lead to disability. In rare cases, severe cases can lead to high-level paraplegia due to cervical spine damage or be life-threatening due to vascular damage to vital organs.

[0003] Rheumatoid arthritis is known in Traditional Chinese Medicine as "Bi disease." Bi disease refers to a series of illnesses caused by insufficient vital energy, wind, cold, dampness, and heat, and the invasion of external pathogens such as wind, cold, dampness, and heat, which block the meridians and impede the smooth flow of qi and blood. Bi disease is primarily caused by insufficient vital energy, followed by the invasion of external pathogens, which are divided into two categories: wind, cold, dampness, and wind, rheumatism, and heat. Therefore, based on a syndrome differentiation and treatment approach tailored to the underlying cause, treatment for this type of disease primarily involves warming the meridians, unblocking the collaterals, expelling pathogens, and alleviating pain. It is primarily categorized into the following types: 1. Wind-Cold Bi Disease. Clinical manifestations include: cold and painful joints that wander, aggravated by cold and relieved by heat; localized skin color that is not red or warm to the touch; difficulty flexing and extending joints; aversion to wind and cold; a pale red tongue or a thin white coating; and a stringy, slow, tight, or floating pulse. 2. Rheumatic Bi-blocking Syndrome. Clinical manifestations: pain, heaviness, wandering pain in the joints and muscles of the limbs, or swelling, aversion to wind, sweating, headache, fever, heaviness in the limbs, difficulty urinating, pale red tongue, thin white or greasy tongue coating, floating or slow pulse. 3. Cold-Damp Bi-blocking Syndrome. Clinical manifestations: swollen and painful joints with localized pain, morning stiffness and difficulty flexing and extending, severe pain when exposed to cold, and localized chills. Thin white tongue coating, floating or sinking pulse. 4. Rheumatic Heat Depression Syndrome. Clinical manifestations: red, swollen, and painful joints, morning stiffness, and limited movement. Also present with aversion to wind and fever, persistent sweating, irritability, thirst, dry stool, and dark urine. Red tongue, yellow or dry coating, slippery and rapid pulse. 5. Mixed Cold and Heat Syndrome. Clinical manifestations: redness, swelling, heat, and pain in the muscles and joints of the limbs, but with localized chills, or a sense of fever but not warmth to the touch; or difficulty flexing and extending the limb joints, relieved by warmth, or even stiffness and deformation of the joints, combined with fever, aversion to cold, pronounced sore throat, yellow urine, dry stool, red tongue with a white or pale tongue coating, and a stringy or taut pulse. 6. Heat Toxin Bi-blockage Syndrome. Clinical manifestations: pronounced redness, swelling, and pain in the joints, relieved by cold, high fever, thirst, red face and throat, dark urine, and constipation, red or crimson tongue with a yellow or greasy coating, and a slippery or stringy pulse. 7. Phlegm and Blood Stasis Syndrome. Clinical manifestations: prolonged joint swelling, stiffness and deformation, limited flexion and extension, fixed pain, pain that feels like a needle prick, less severe during the day and worse at night, and dry mouth with no desire to drink. The tongue is dark purple with a greasy white coating, and the pulse is thin, astringent, or slippery. 8. Kidney deficiency and cold stagnation syndrome. Clinical manifestations: joint pain and swelling, morning stiffness, difficulty moving, fear of cold, fatigue, back pain, difficulty bending forward or backward, worsened in cold weather, pale, plump tongue with a white, slippery coating, and a deep, thready pulse. 9. Liver and kidney yin deficiency syndrome. Clinical manifestations: long-standing joint swelling and deformity, localized burning pain in joints, difficulty flexing and extending, emaciated figure, and soreness and weakness in the waist and knees. Associated symptoms include dizziness, tinnitus, night sweats, insomnia, a red tongue with scanty coating, and a thready pulse. Cold-dampness arthralgia syndrome is the most common. Summary of the Invention

[0004] The purpose of this application is to provide a traditional Chinese medicine composition for treating rheumatoid arthritis pain, which can treat rheumatoid arthritis pain and has the functions of diuresis and dehumidification, warming yang and dispersing cold, strengthening the spleen and removing dampness, resolving phlegm and expelling fluid, invigorating qi and nourishing blood, strengthening the spleen and nourishing the stomach, promoting blood circulation and removing blood stasis, dispersing wind and clearing heat, and soothing the liver and regulating qi.

[0005] Another object of the present application is to provide a method for preparing a traditional Chinese medicine composition for treating rheumatoid arthritis pain, which can effectively extract the effective components in the medicinal materials, thereby maximizing the medicinal effects of the medicinal materials.

[0006] The present application solves the technical problem by adopting the following technical solutions.

[0007] A traditional Chinese medicine composition for treating rheumatoid arthritis pain is prepared from the following traditional Chinese medicines in parts by weight: 20-30 parts of Poria cocos, 18-22 parts of Lysimachia scabra, 5-10 parts of Aconite root, 10-20 parts of cinnamon twig, 20-30 parts of stir-fried Atractylodes macrocephala with bran, 20-30 parts of Codonopsis pilosula, 5-10 parts of Fritillaria thunbergii, 18-22 parts of Prunella vulgaris, 18-22 parts of dried tangerine peel, 15-25 parts of Sinapis alba, 15-25 parts of Achyranthes bidentata, 18-22 parts of Carthamus tinctorius, 20-30 parts of Leonurus japonicus, 20-30 parts of Angelica sinensis, 18-22 parts of Stephania tetrandra, 20-30 parts of Forsythia suspensa, 25-35 parts of Gardenia jasminoides, 20-30 parts of Anemarrhena rhizome, 18-22 parts of Corydalis yanhusuo, 20-30 parts of Prunus mume, 18-22 parts of Citron, 15-25 parts of Cyperus rotundus, 10-20 parts of Achyranthes bidentata, and 15-25 parts of Dipsacus asper.

[0008] The traditional Chinese medicine composition for treating rheumatoid arthritis pain is prepared from the following traditional Chinese medicines in parts by weight: 25 parts of Poria cocos, 20 parts of Lysimachia scabra, 8 parts of Aconite root, 15 parts of Cinnamon twig, 25 parts of Rhizoma Atractylodis Macrocephalae with bran, 25 parts of Codonopsis pilosula, 8 parts of Fritillaria thunbergii, 20 parts of Prunella vulgaris, 20 parts of Citrus reticulatae, 20 parts of Sinapis alba seeds, 20 parts of Rhizoma Achyranthis Bidentatae, 20 parts of Carthamus tinctorius, 25 parts of Leonurus japonicus, 25 parts of Angelica sinensis, 20 parts of Stephania tetrandrae, 25 parts of Forsythia suspensa, 30 parts of Gardenia jasminoides, 25 parts of Rhizoma Anemarrhenae, 20 parts of Rhizoma Corydalis, 25 parts of Prunus mume, 20 parts of Citron, 20 parts of Cyperus rotundus, 15 parts of Achyranthes bidentatae, and 20 parts of Dipsacus asper.

[0009] The traditional Chinese medicine composition for treating rheumatoid arthritis pain is prepared from the following traditional Chinese medicines in parts by weight: 20 parts of Poria cocos, 22 parts of Lysimachia chinensis, 5 parts of Aconite root, 20 parts of Cinnamon twig, 20 parts of Rhizoma Atractylodis Macrocephalae with bran, 30 parts of Codonopsis pilosula, 5 parts of Fritillaria thunbergii, 22 parts of Prunella vulgaris, 18 parts of Citrus reticulatae, 25 parts of Sinapis alba seeds, 15 parts of Rhizoma Achyranthis Bidentatae, 22 parts of Carthamus tinctorius, 20 parts of Leonurus japonicus, 30 parts of Angelica sinensis, 18 parts of Stephania tetrandrae, 30 parts of Forsythia suspensa, 25 parts of Gardenia jasminoides, 30 parts of Rhizoma Anemarrhenae, 18 parts of Rhizoma Corydalis, 30 parts of Prunus mume, 18 parts of Citron, 25 parts of Cyperus rotundus, 10 parts of Achyranthes bidentata, and 25 parts of Dipsacus asper.

[0010] The traditional Chinese medicine composition for treating rheumatoid arthritis pain is prepared from the following traditional Chinese medicines in parts by weight: 30 parts of Poria cocos, 18 parts of Lysimachia scabra, 10 parts of Aconite root, 10 parts of Cinnamon twig, 30 parts of Rhizoma Atractylodis Macrocephalae with bran, 20 parts of Codonopsis pilosula, 10 parts of Fritillaria thunbergii, 18 parts of Prunella vulgaris, 22 parts of Citrus reticulatae, 15 parts of Sinapis alba, 25 parts of Rhizoma Atractylodis Macrocephalae, 18 parts of Carthamus tinctorius, 30 parts of Leonurus japonicus, 20 parts of Angelica sinensis, 22 parts of Stephania tetrandra, 20 parts of Forsythia suspensa, 35 parts of Gardenia jasminoides, 20 parts of Rhizoma Anemarrhenae, 22 parts of Rhizoma Corydalis, 20 parts of Prunus mume, 22 parts of Citron, 15 parts of Cyperus rotundus, 20 parts of Achyranthes bidentata, and 15 parts of Dipsacus asper.

[0011] The traditional Chinese medicine composition for treating rheumatoid arthritis pain is prepared by:

[0012] (1) Grind safflower, motherwort, angelica, bergamot, and cyperus rotundus, add 6-10 times the weight of 60-90% ethanol, extract twice, each time for 1-3 hours, filter, combine the filtrates, and concentrate to obtain an alcohol-extracted clear paste;

[0013] (2) After crushing the other medicinal materials, add 10-12 times the weight of water and reflux extract twice, each time for 2-4 hours, filter, combine the filtrate, and concentrate to obtain a water-extracted clear paste;

[0014] (3) The alcohol-extracted paste obtained in step (1) and the water-extracted paste obtained in step (2) are combined, mixed evenly, concentrated, and dried to obtain a Chinese medicine composition.

[0015] The traditional Chinese medicine composition for treating rheumatoid arthritis pain is in the form of capsules, tablets, granules, oral liquids, pills and powders.

[0016] The traditional Chinese medicine composition for treating rheumatoid arthritis pain is prepared by:

[0017] (1) Grind safflower, motherwort, angelica, bergamot, and cyperus rotundus, add 8 times the weight of 75% ethanol, extract twice, each time for 2 hours, filter, combine the filtrates, and concentrate to obtain an alcohol-extracted clear paste;

[0018] (2) After crushing the other medicinal materials, add 11 times the weight of water and reflux extract twice, each time for 3 hours, filter, combine the filtrate, and concentrate to obtain a water-extracted clear paste;

[0019] (3) The alcohol-extracted paste obtained in step (1) and the water-extracted paste obtained in step (2) are combined, mixed evenly, concentrated, and dried to obtain a Chinese medicine composition.

[0020] The invention relates to an application of the traditional Chinese medicine composition for treating rheumatoid arthritis pain in preparing a medicine for treating rheumatoid arthritis pain.

[0021] The use of the traditional Chinese medicine composition for treating rheumatoid arthritis pain in preparing a drug for treating rheumatoid arthritis pain is characterized in that the rheumatoid arthritis pain belongs to cold-dampness arthritis syndrome.

[0022] Summer Wuwei uses the dried tuber of Coydalis decumbens (Thunb.) Pers., a plant of the genus Corydalis in the Papaveraceae family. It promotes blood circulation, relieves pain, and dispels wind and dampness. It is primarily used to treat hemiplegia caused by stroke, injuries from falls, liver-yang headaches, rheumatic pain, and joint cramps.

[0023] Green-calyx plum is the dried flower buds of Prunus mume Sieb. et Zucc., a plant in the Rosaceae family. It has the effects of soothing liver qi, relieving depression, harmonizing the middle stomach, and resolving phlegm. It is mainly used to treat liver and stomach qi pain and plum pit qi.

[0024] The remaining medicinal materials all comply with the Chinese Pharmacopoeia standards or local standards.

[0025] The Chinese medicine of the present invention can be replaced by Chinese medicines with the same or similar effects, and these medicinal materials can be prepared according to the "National Chinese Medicine Processing Standards" or the "Chinese Medicine Dictionary".

[0026] Cold-dampness arthritis syndrome presents with clinical symptoms of localized joint swelling and pain, morning stiffness that makes flexion and extension difficult, increased pain with exposure to cold, and localized chills. A thin white tongue coating and a floating or sinking pulse correspond to rheumatoid arthritis in modern medicine. The severe, fixed pain is due to cold, a yin pathogen with a stagnant nature. Qi and blood are blocked by cold, leading to pain and cramps in the meridians, like ice freezing in water. Furthermore, the severe pain makes flexion and extension even more difficult. Heat temporarily dissipates the cold, allowing qi and blood to circulate, temporarily alleviating the pain. However, exposure to cold further congests blood and qi, exacerbating the pain. Cold is most likely to damage yang qi, leading to stagnation of qi and blood, resulting in blood stasis and phlegm-dampness, exacerbating the condition. Clinically, pain and arthritis often present with blood stasis, manifesting as tingling, numbness, and stiffness in the joints. Cold-dampness also often combines, manifesting as pain accompanied by a feeling of coldness, heaviness, or joint swelling. The combined effects of cold and dampness often affect the waist and lower extremities. If cold phlegm enters the extremities, pain is localized and heavy. Dampness is a yin pathogen, heavy, turbid, and sticky in nature, hence the term "zhuibi." Pain is often localized. Dampness stagnates, disrupting the smooth flow of Qi and blood, resulting in pain and numbness. While not intense, the pain is characterized by lingering pain, heaviness, and numbness. Movement is limited by the heaviness and difficulty of moving the joints. Dampness results from external dampness in the pores of the skin, or from pathological retention of body fluids. Whether caused by external pathogens or internally generated dampness, it is associated with dysfunction of the spleen's transportation and transformation functions. Consequently, symptoms of spleen deficiency and dampness are often present, including chest tightness, poor appetite, abdominal distension, loose stools, a pale tongue with a greasy coating, and a weak pulse. The joints of the limbs are often swollen, which is also a sign that dampness has gathered in the joints. When dampness is excessive, the Yang is weak, so the person likes warmth and fears cold. After being comforted by heat and massage, the Yang Qi is temporarily unblocked, so the pain and numbness can be slightly reduced. However, after a while, the dampness will gather again and the pain will return to the same state.

[0027] The prescription of the present invention is based on the following: first, cold-dampness arthralgia is caused by the prevalence of dampness and the obstruction of the water channel. The "Golden Chamber Synopsis: Jingshihuangbing Pulse Symptoms and Treatments" clearly states: "Dampness arthralgia is characterized by difficulty in urination and rapid bowel movements, but urination should be facilitated," emphasizing that diuresis is one of the core means of removing dampness. At the same time, the "Yellow Emperor's Internal Classic" proposes "opening the ghost gate and cleansing the internal organs," wherein "cleansing the internal organs" refers to promoting urination to eliminate dampness. Therefore, in cold-dampness arthralgia, dampness often binds to cold. Diuresis removes dampness, causing the cold to lose its attachment, and is combined with warming yang and dispersing cold drugs. Second, cold-dampness arthralgia is prone to cause spleen dysfunction over time, resulting in the inability to transform water and dampness, which accumulates and forms phlegm. Internal obstruction of phlegm and dampness can exacerbate meridian obstruction, forming a syndrome of "phlegm and blood stasis," characterized by joint swelling, deformity, and numbness. Physical weakness, insufficient vital energy, or a deficiency of defensive energy are all inherent factors in the development of cold-dampness obstruction. The Treatise on the Spleen and Stomach states, "The spleen and stomach are the first to be affected, causing heaviness or numbness..." "Deficiency of central qi... causes numbness to flow through the meridians throughout the body." Spleen and stomach weakness is closely linked to the development and progression of numbness. "The spleen is strong throughout the four seasons and is immune to pathogens," so the treatment approach is to invigorate qi and nourish blood, strengthen the spleen and eliminate dampness, and resolve phlegm and expel fluid. Thirdly, this stems from the detailed discussion of "blood stasis as arthritis" in "Medical Errors Correction: Theory of Blood Stasis in Arthritis." Cold-damp arthritis is often associated with blood stasis, so the treatment approach is to activate blood circulation and dissolve blood stasis. Fourthly, Ye Tianshi stated in "Clinical Guide Medical Cases" that "damp-heat flows, causing pain in the limbs," and "at the beginning of the disease, damp-heat is in the meridians, but over time, stagnant heat enters the collaterals." Cold-damp arthritis often manifests as cold turning into heat, so the treatment approach is to dispel wind and clear heat. Fifthly, in the pathogenesis of rheumatoid arthritis associated with cold-damp arthritis, the liver is responsible for dispersing qi and regulating the flow of qi. Normal liver function ensures a smooth flow of qi. Qi is the commander of blood, and blood is the mother of qi. Flowing qi circulates blood, while stagnant qi causes blood to clot. If the liver qi is not released, qi stagnation will occur over time, and blood will become stagnant and not flow smoothly. The unreleased qi will inevitably lead to stagnant blood. If the stasis lasts for a long time, the body fluid in the blood will seep out and produce phlegm and dampness. Therefore, the method of soothing the liver and regulating qi is adopted to regulate the qi, unblock qi and blood, and alleviate symptoms.

[0028] Therefore, the present invention adopts Poria, Herba Lysimachiae, Radix Aconiti Lateralis Preparata and Cinnamomum cassiae as monarch drugs, which can promote urination to eliminate dampness, warm yang and dispel cold; selects Rhizoma Atractylodis Macrocephalae, Radix Codonopsis, Fritillaria Thunbergii, Herba Prunellae, Pericarpium Citri Reticulatae and Semen Sinapis Albae as ministerial drugs, which can invigorate the spleen and eliminate dampness, resolve phlegm and expel fluid, invigorate qi and nourish blood, invigorate the spleen and nourish the stomach; Rhizoma Cyperi, Carthamus Tinctorius, Herba Leonuri and Radix Angelicae Sinensis can invigorate blood circulation and dissipate blood stasis; Radix Stephaniae Tetrandrae, Fructus Forsythiae, Fructus Gardeniae and Rhizoma Anemarrhenae can dispel wind and clear heat, and are all adjuvant drugs; Rhizoma Corydalis, Prunus Amygdalus, Citron and Rhizoma Cyperi can soothe the liver and regulate qi, and rheumatoid arthritis often causes pain in the lower limbs, and Achyranthes bidentata and Dipsacus as guiding drugs are used as guiding drugs, especially Rhizoma Corydalis, which is bitter, pungent, warm and non-toxic, is good at promoting qi stagnation in blood, blood stagnation in qi, specializes in promoting blood circulation and dispersing blood stasis, promoting qi and relieving pain, and can regulate various pains throughout the body, and is a "magic drug for invigorating blood circulation and transforming qi". The whole formula contains Poria cocos, Centella asiatica, Aconitum, cinnamon twig, stir-fried Atractylodes macrocephala, Codonopsis pilosula, Fritillaria thunbergii, Prunella vulgaris, dried tangerine peel, white mustard seed, Achyranthes bidentata, safflower, Leonurus japonicus, Angelica sinensis, Stephania tetrandra, Forsythia suspensa, Gardenia jasminoides, Anemarrhena asphodeloides, Corydalis yanhusuo, Prunus mume, Citrus hand, Cyperus rotundus, Achyranthes bidentata, and Dipsacus asper. It can treat rheumatoid arthritis of the cold-dampness syndrome type through diuresis and dehumidification, warming yang and dispersing cold, strengthening the spleen and eliminating dampness, resolving phlegm and expelling fluid, invigorating Qi and nourishing blood, strengthening the spleen and nourishing the stomach, promoting blood circulation and removing blood stasis, dispersing wind and clearing heat, and soothing the liver and regulating Qi.

[0029] The traditional Chinese medicine composition of the present invention mainly consists of tuckahoe, herbaceous limon, aconite root, cinnamon twig, stir-fried atractylodes macrocephala, codonopsis pilosula, fritillaria thunbergii, selfheal, tangerine peel, white mustard seed, summer sedge, safflower, motherwort, angelica, stephania tetrandra, forsythia suspensa, gardenia jasminoides, rhizoma anemarrhenae, corydalis yanhusuo, euphorbia pulcherrima, citron, rhizoma cyperi, achyranthes bidentata, and dipsaccharum officinale. The composition gives full play to the overall regulation advantage of the compound traditional Chinese medicine, has the characteristics of multi-directionality, multi-level and multi-target, and has been clinically proven to be effective in treating rheumatoid arthritis of cold-dampness arthritis syndrome, with obvious improvement in symptoms, erythrocyte sedimentation rate and C-reactive protein. DETAILED DESCRIPTION

[0030] Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiments are only used to illustrate the present invention and are not used in limiting the scope of the present invention.In addition, should be understood that after reading the content of the present invention record, those skilled in the art can make various changes or modifications to the present invention, but these equivalent forms fall within the scope limited by the application's appended claims equally.

[0031] Example 1: Take 25g of Poria, 20g of Lysimachia chinensis, 8g of Aconite, 15g of Cinnamon Twig, 25g of Rhizoma Atractylodis Macrocephalae, 25g of Codonopsis pilosula, 8g of Fritillaria thunbergii, 20g of Prunella Vulgaris, 20g of Tangerine Peel, 20g of White Sinapis, 20g of Summer Herb, 20g of Carthamus tinctorius, 25g of Leonurus japonicus, 25g of Angelica sinensis, 20g of Stephania tetrandra, 25g of Forsythia suspensa, 30g of Gardenia jasminoides, 25g of Anemarrhena, 20g of Corydalis yanhusuo, 25g of Prunus mume, 20g of Citron, 20g of Cyperus rotundus, 15g of Achyranthes bidentata, and 20g of Dipsacus asper. The preparation method is as follows;

[0032] (1) Grind safflower, motherwort, angelica, bergamot, and cyperus rotundus, add 8 times the weight of 75% ethanol, extract twice, each time for 2 hours, filter, combine the filtrates, and concentrate to obtain an alcohol-extracted clear paste;

[0033] (2) After crushing the other medicinal materials, add 11 times the weight of water and reflux extract twice, each time for 3 hours, filter, combine the filtrate, and concentrate to obtain a water-extracted clear paste;

[0034] (3) The alcohol-extracted paste obtained in step (1) and the water-extracted paste obtained in step (2) are combined, mixed, concentrated, dried, and supplemented with auxiliary materials to prepare granules.

[0035] Example 2: Poria 20g, Lysimachia 22g, Aconite 5g, Cinnamon twig 20g, Rhizoma Atractylodis Macrocephalae 20g, Codonopsis pilosula 30g, Fritillaria thunbergii 5g, Prunella vulgaris 22g, Tangerine peel 18g, Sinapis alba 25g, Rhizoma Amygdaloides 15g, Carthamus tinctorius 22g, Leonurus japonicus 20g, Angelica sinensis 30g, Stephania tetrandra 18g, Forsythia suspensa 30g, Gardenia jasminoides 25g, Rhizoma Anemarrhenae 30g, Rhizoma Corydalis 18g, Prunus mume 30g, Citrus palm 18g, Cyperus rotundus 25g, Achyranthes bidentata 10g, Dipsacus asper 25g, preparation method:

[0036] (1) Grind safflower, motherwort, angelica, bergamot, and cyperus rotundus, add 8 times the weight of 75% ethanol, extract twice, each time for 2 hours, filter, combine the filtrates, and concentrate to obtain an alcohol-extracted clear paste;

[0037] (2) After crushing the other medicinal materials, add 11 times the weight of water and reflux extract twice, each time for 3 hours, filter, combine the filtrate, and concentrate to obtain a water-extracted clear paste;

[0038] (3) The alcohol-extracted paste obtained in step (1) and the water-extracted paste obtained in step (2) are combined, mixed, concentrated, dried, and supplemented with auxiliary materials to prepare tablets.

[0039] Example 3: Take 30g of Poria, 18g of Lysimachia chinensis, 10g of Aconite, 10g of Cinnamon Twig, 30g of Rhizoma Atractylodis Macrocephalae with bran, 20g of Codonopsis pilosula, 10g of Fritillaria thunbergii, 18g of Prunella Vulgaris, 22g of Tangerine Peel, 15g of Sinapis alba, 25g of Rhizoma Citri Reticulatae, 18g of Carthamus tinctorius, 30g of Leonurus japonicus, 20g of Angelica sinensis, 22g of Stephania tetrandra, 20g of Forsythia suspensa, 35g of Gardenia jasminoides, 20g of Rhizoma Anemarrhenae, 22g of Rhizoma Corydalis, 20g of Prunus mume, 22g of Citron, 15g of Cyperus rotundus, 20g of Achyranthes bidentata, and 15g of Dipsacus asper. The preparation method is as follows;

[0040] (1) Grind safflower, motherwort, angelica, bergamot, and cyperus rotundus, add 8 times the weight of 75% ethanol, extract twice, each time for 2 hours, filter, combine the filtrates, and concentrate to obtain an alcohol-extracted clear paste;

[0041] (2) After crushing the other medicinal materials, add 11 times the weight of water and reflux extract twice, each time for 3 hours, filter, combine the filtrate, and concentrate to obtain a water-extracted clear paste;

[0042] (3) The alcohol-extracted paste obtained in step (1) and the water-extracted paste obtained in step (2) are combined, mixed, concentrated, dried, and supplemented with auxiliary materials to prepare capsules.

[0043] Example 4: Pharmacodynamics Study

[0044] Forty-eight male SD rats weighing 200±20g were injected intradermally with Freund's complete adjuvant (containing 7.5mg / ml BCG) at the right hind paw. One week after inflammation, the rats were randomly divided into four groups, each with eight rats: (1) normal group with 10ml / kg normal saline; (2) model group with 10ml / kg normal saline; (3) control group with 10g / kg Hanshibi granules (National Medicine Standard Z20044061, Liaoning Shangyao Haohushi Pharmaceutical (Group) Co., Ltd., batch number 20230509); and (4) group with 10g / kg granules of Example 1 of the present invention. Each group was given the drug by gavage once a day for 21 consecutive days. On day 22 of the experiment, rats were bled from their carotid arteries and various parameters were measured, including superoxide dismutase (SOD) levels using the pyrogallol autooxidation inhibition assay and interleukin-1 (IL-1) levels using the mouse thymocyte proliferation assay. Plasma was then separated using 2% EDTA-Na₂ anticoagulation and prostaglandin E₂ (PGE₂) and thromboxane B₂ (TXB₂) levels were measured using an FMJ-182 radioimmunoγ counter. The results are shown in Table 1.

[0045] Table 1 Effects of the present invention on SOD, IL-1, PGE2 and TXB2 in model rats

[0046]

[0047] Compared with the normal group # p<0.05, ## p<0.01; compared with the model group * p<0.05, ** p<0.01

[0048] As shown in Table 1, the effects of the present invention on superoxide dismutase (SOD) were significant between the model group and the normal group, indicating successful model establishment. The present invention significantly increased serum SOD levels in rats with Freund's complete adjuvant arthritis, with a significant difference compared to the model group and a better effect than the positive drug group. The effects of the present invention on interleukin-1 (IL-1) were significant between the model group and the normal group, indicating successful model establishment. The present invention significantly reduced serum IL-1 levels in rats with Freund's complete adjuvant arthritis, with a significant difference compared to the model group and a better effect than the positive drug group. The effects on prostaglandin E2 (PGE2) were significant between the present invention and the normal group, indicating successful model establishment. The present invention significantly reduced plasma PGE2 and TXB2 levels in rats with Freund's complete adjuvant arthritis, with a significant difference compared to the model group and a better effect than the positive drug group.

[0049] During the pathological process of rheumatoid arthritis, a large number of oxygen-derived free radicals are generated, forming lipid peroxides (LPO), which severely damage cartilage and interstitial connective tissue. This invention significantly increases the activity of the endogenous antioxidant enzyme SOD, enhancing the body's antioxidant system to clear excess LPO and mitigate free radical damage to joints. IL-1 is the cytokine most closely associated with rheumatoid arthritis. It is both an immunomodulatory factor and an inflammatory mediator. It activates lymphocytes, stimulates B cells to increase antibody production, and induces the production of progesterone (PGE2) and collagenase, causing arthritis and cartilage destruction. It also enhances osteoclast activity, leading to osteoporosis and bone loss. TXA2 can cause severe vasoconstriction, platelet aggregation, and increased blood viscosity, leading to thrombosis. It can also promote the proliferation of granulation tissue in joints. This invention can reduce IL-1 levels, inhibit the onset and progression of bone destruction, and reduce TXA2 levels, promoting blood circulation and restoring joint function.

[0050] Example 5: Clinical trial

[0051] 1. Diagnostic Criteria: Western medicine diagnostic criteria follow the American Rheumatology Association's 1987 RA classification criteria. Traditional Chinese Medicine diagnostic criteria follow the Ministry of Health's "Guiding Principles for Clinical Research of New Traditional Chinese Medicines for the Treatment of Bi Diseases," combined with TCM syndrome differentiation and diagnostic criteria for Bi disease. The syndrome is classified as cold-dampness-restrained. Joint function scoring follows the functional classification criteria for rheumatoid arthritis. Clinical Manifestations: Joint swelling and pain with localized pain, morning stiffness with difficulty flexing and extending, increased pain with cold, and localized chills. The tongue coating is thin and white, and the pulse is either floating or sinking.

[0052] 2. Efficacy criteria: The criteria were formulated with reference to the “Efficacy Criteria for Diagnosis of TCM Diseases and Syndromes” issued by the State Administration of Traditional Chinese Medicine. (1) Clinical control: The overall improvement rate of major symptoms and signs was ≥75%, and the erythrocyte sedimentation rate and C-reactive protein were normal or significantly improved or close to normal; (2) Markedly effective: The overall improvement rate of major symptoms and signs was ≥50%, and the erythrocyte sedimentation rate and C-reactive protein were improved; (3) Effective: The overall improvement rate of major symptoms and signs was ≥30%, and the erythrocyte sedimentation rate and C-reactive protein were improved or not improved; (4) Ineffective: The overall improvement rate of major symptoms and signs was <30%, and the erythrocyte sedimentation rate and C-reactive protein were not improved.

[0053] 3. Research Methods: This study employed a randomized controlled clinical trial approach, randomly assigning 100 patients to a treatment group (decorated with Example 1 of the present invention) and a control group for observation of clinical efficacy. The treatment group consisted of 50 patients, while the control group consisted of 50 patients. The control group was given Hanshibi Granules (National Medicine Standard No. Z20044061, Liaoning Shangyao Haohushi Pharmaceutical (Group) Co., Ltd., Approval No. 20230509) orally, 10g three times daily. The treatment group was treated with the granules prepared in Example 1 of the present invention (daily dosage of medicinal materials: 40 g of Xuan papaya, 25 g of kapok, 20 g of Fructus Lour., 30 g of Caulis Piperis, 20 g of Herba Lycopodii, 25 g of Ginseng, 30 g of Rhizoma Atractylodis Macrocephalae, 25 g of Poria, 20 g of Codonopsis pilosula, 20 g of Rhizoma Cibotii, 20 g of Carthamus tinctorius, 25 g of Leonurus japonicus, 25 g of Angelica sinensis, 20 g of Stephania tetrandra, 25 g of Forsythia suspensa, 30 g of Gardenia jasminoides, 25 g of Rhizoma Anemarrhenae, 20 g of Rhizoma Corydalis, 25 g of Prunus mume, 20 g of Citronella, 20 g of Cyperus rotundus, 15 g of Achyranthes bidentata, and 20 g of Dipsacus asper), taken three times a day. The efficacy of both groups was statistically analyzed after 2 months of treatment.

[0054] 4. Observation indicators: Morning stiffness duration (min), number of tender joints, number of swollen joints, and 20-meter walking time. Rheumatoid factor (RF), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) were also measured.

[0055] 5. Results

[0056] 5.1 Comparison of clinical efficacy between the two groups: In the treatment group, there were 50 cases, 11 cases were clinically controlled, 17 cases were significantly effective, 19 cases were effective, 3 cases were ineffective, and the total effective rate was 94.00%; in the control group, there were 50 cases, 7 cases were clinically controlled, 15 cases were significantly effective, 16 cases were effective, 12 cases were ineffective, and the total effective rate was 76.00%; the comparison of clinical efficacy between the two groups showed statistically significant difference (P<0.05).

[0057] 5.2 The observed indicators in both groups improved before and after treatment, but the improvement in the treatment group was more obvious, see Table 2.

[0058] Table 2 Observation of indicators before and after treatment of the present invention and the control group

[0059]

[0060] Compared with before treatment * p<0.05 ** p<0.01

[0061] 5.3 Comparison of RF, CRP and ESP between the two groups before and after treatment showed that the observation group was lower than the control group (P < 0.05), see Table 3.

[0062] Table 3 Comparison of RF, CRP, and ESP before and after treatment in the present invention and the control group

[0063]

[0064] Compared with before treatment * p<0.05 ** p<0.01

[0065] 6. Conclusion: This invention has a definite clinical efficacy in treating rheumatoid arthritis of the cold-dampness type by promoting diuresis and removing dampness, warming yang and dispersing cold, strengthening the spleen and removing dampness, resolving phlegm and expelling fluid, replenishing qi and nourishing blood, strengthening the spleen and nourishing the stomach, promoting blood circulation and removing stasis, dispersing wind and clearing heat, and soothing the liver and regulating qi.

[0066] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine composition for treating rheumatoid arthritis pain, characterized in that: The invention is prepared from the following traditional Chinese medicines in parts by weight: 20-30 parts of Poria cocos, 18-22 parts of Lysimachia scabra, 5-10 parts of Aconite root, 10-20 parts of cinnamon twig, 20-30 parts of stir-fried Atractylodes macrocephala, 20-30 parts of Codonopsis pilosula, 5-10 parts of Fritillaria thunbergii, 18-22 parts of Prunella vulgaris, 18-22 parts of dried tangerine peel, 15-25 parts of white mustard seeds, 15-25 parts of Summerleaf schizonepeta, 18-22 parts of Carthamus tinctorius, 20-30 parts of Leonurus japonicus, 20-30 parts of Angelica sinensis, 18-22 parts of Stephania tetrandra, 20-30 parts of Forsythia suspensa, 25-35 parts of Gardenia jasminoides, 20-30 parts of Anemarrhena rhizome, 18-22 parts of Corydalis yanhusuo, 20-30 parts of Prunus mume, 18-22 parts of Citrus citron, 15-25 parts of Cyperus rotundus, 10-20 parts of Achyranthes bidentata, and 15-25 parts of Dipsacus asper.

2. A Chinese medicine composition for treating rheumatoid arthritis pain according to claim 1, characterized in that: The invention is prepared from the following traditional Chinese medicines in parts by weight: 25 parts of Poria cocos, 20 parts of Herba Lysimachiae, 8 parts of Radix Aconiti Lateralis Preparata, 15 parts of Cinnamon Twig, 25 parts of Rhizoma Atractylodis Macrocephalae with bran, 25 parts of Codonopsis pilosula, 8 parts of Fritillaria thunbergii, 20 parts of Spica Prunellae, 20 parts of Pericarpium Citri Reticulatae, 20 parts of Sinapis Albae Seeds, 20 parts of Rhizoma Cyperi, 20 parts of Leonurus japonicus, 25 parts of Angelica sinensis, 20 parts of Stephania tetrandrae, 25 parts of Forsythia suspensa, 30 parts of Gardenia jasminoides, 25 parts of Rhizoma Anemarrhenae, 20 parts of Rhizoma Corydalis, 25 parts of Prunus mume, 20 parts of Citron, 20 parts of Rhizoma Cyperi, 15 parts of Achyranthes bidentata, and 20 parts of Dipsacus asper.

3. A Chinese medicine composition for treating rheumatoid arthritis pain according to claim 1, characterized in that: The invention is prepared from the following traditional Chinese medicines in parts by weight: 20 parts of Poria cocos, 22 parts of Herba Lysimachiae, 5 parts of Radix Aconiti Lateralis Preparata, 20 parts of Cinnamon Twig, 20 parts of Rhizoma Atractylodis Macrocephalae with bran, 30 parts of Codonopsis pilosula, 5 parts of Fritillaria thunbergii, 22 parts of Spica Prunellae, 18 parts of Pericarpium Citri Reticulatae, 25 parts of Sinapis Albae Seeds, 15 parts of Rhizoma Citri Reticulatae, 22 parts of Carthamus tinctorius, 20 parts of Leonurus japonicus, 30 parts of Angelica sinensis, 18 parts of Stephania tetrandrae, 30 parts of Forsythia suspensa, 25 parts of Gardenia jasminoides, 30 parts of Rhizoma Anemarrhenae, 18 parts of Rhizoma Corydalis, 30 parts of Prunus mume, 18 parts of Citron, 25 parts of Rhizoma Cyperi, 10 parts of Achyranthes bidentata, and 25 parts of Dipsacus asper.

4. A Chinese medicine composition for treating rheumatoid arthritis pain according to claim 1, characterized in that: The invention is prepared from the following traditional Chinese medicines in parts by weight: 30 parts of Poria cocos, 18 parts of Herba Lysimachiae, 10 parts of Radix Aconiti Lateralis Preparata, 10 parts of Rhizoma Cinnamomi, 30 parts of Rhizoma Atractylodis Macrocephalae stir-fried with bran, 20 parts of Codonopsis pilosula, 10 parts of Fritillaria thunbergii, 18 parts of Spica Prunellae, 22 parts of Pericarpium Citri Reticulatae, 15 parts of Sinapis Albae, 25 parts of Rhizoma Atractylodis Macrocephalae, 18 parts of Carthamus tinctorius, 30 parts of Leonurus japonicus, 20 parts of Angelica sinensis, 22 parts of Stephania tetrandrae, 20 parts of Forsythia suspensa, 35 parts of Gardenia jasminoides, 20 parts of Rhizoma Anemarrhenae, 22 parts of Rhizoma Corydalis, 20 parts of Prunus mume, 22 parts of Citron, 15 parts of Rhizoma Cyperi, 20 parts of Achyranthes bidentata, and 15 parts of Dipsacus asper.

5. A Chinese medicine composition for treating rheumatoid arthritis pain according to claim 1, characterized in that: The preparation method is: (1) Grind safflower, motherwort, angelica, bergamot, and cyperus rotundus, add 6-10 times the weight of 60-90% ethanol, extract twice, each time for 1-3 hours, filter, combine the filtrates, and concentrate to obtain an alcohol-extracted clear paste; (2) After crushing the other medicinal materials, add 10-12 times the weight of water and reflux extract twice, each time for 2-4 hours, filter, combine the filtrate, and concentrate to obtain a water-extracted clear paste; (3) The alcohol-extracted paste obtained in step (1) and the water-extracted paste obtained in step (2) are combined, mixed evenly, concentrated, and dried to obtain a Chinese medicine composition.

6. A Chinese medicine composition for treating rheumatoid arthritis pain according to claim 5, characterized in that: The Chinese medicine composition is one of capsules, tablets, granules, oral liquids, pills and powders.

7. A Chinese medicine composition for treating rheumatoid arthritis pain according to claim 5, characterized in that: The preparation method is: (1) Grind safflower, motherwort, angelica, bergamot, and cyperus rotundus, add 8 times the weight of 75% ethanol, extract twice, each time for 2 hours, filter, combine the filtrates, and concentrate to obtain an alcohol-extracted clear paste; (2) After crushing the other medicinal materials, add 11 times the weight of water and reflux extract twice, each time for 3 hours, filter, combine the filtrate, and concentrate to obtain a water-extracted clear paste; (3) The alcohol-extracted paste obtained in step (1) and the water-extracted paste obtained in step (2) are combined, mixed evenly, concentrated, and dried to obtain a Chinese medicine composition.

8. Use of the traditional Chinese medicine composition for treating rheumatoid arthritis pain as claimed in claim 1 in preparing a medicine for treating rheumatoid arthritis pain.

9. Use of a traditional Chinese medicine composition for treating rheumatoid arthritis pain according to claim 8 in preparing a drug for treating rheumatoid arthritis pain, characterized in that: Rheumatoid arthritis pain belongs to the syndrome of cold and dampness obstruction.

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