A traditional Chinese medicine composition for treating rheumatoid arthritis and a preparation method thereof

Abstract

The present application relates to the technical field of traditional Chinese medicine compound preparation, and discloses a traditional Chinese medicine composition for treating rheumatoid arthritis and a preparation method thereof, which comprises Ephedra, Radix Clematidis, Radix Hedysari, Radix Angelicae Pubescentis, Eucommia ulmoides, Gastrodia elata Blume, Fructus Corni, Radix Lycii, Gentiana, Crocus sativus, Fructus Evodiae, Chuanxiong, Scorpio, Plastrum Testudinis, Radix Notoginseng, Saposhnikovia divaricata, Rhizoma Corydalis, Angelica sinensis, Curcuma zedoary, Radix Ligustici Wallichii, Radix Glycyrrhizae.The present application is prepared according to the compatibility idea of expelling wind and removing dampness, dredging collaterals to stop pain, promoting blood circulation to remove blood stasis and tonifying liver and kidney, and is aimed at the pathogenesis of rheumatoid arthritis, wind-dampness arthralgia, liver and kidney deficiency and blood stasis blocking collaterals.The traditional Chinese medicine composition can quickly relieve joint swelling, pain and morning stiffness, and can also nourish liver and kidney, strengthen muscles and bones and delay joint bone destruction.The traditional Chinese medicine composition can be prepared into decoction, powder or pill, has safe compatibility, fast clinical effect, low recurrence rate, no obvious toxic and side effects, and is suitable for long-term use for intervention of rheumatoid arthritis.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine compound preparations, and more specifically, to a traditional Chinese medicine composition for treating rheumatoid arthritis and its preparation method. Background Technology

[0002] Rheumatoid arthritis (RA) is an autoimmune disease with synovitis as its pathological basis, which may eventually lead to joint deformities. Clinically, joint involvement is the primary manifestation, with initial symptoms including morning stiffness, swelling, and pain. As the disease progresses, joint deformities may develop, affecting normal joint function. Some patients may also experience systemic symptoms such as fever and fatigue. Traditional Chinese medicine classifies rheumatoid arthritis under the category of "Bi syndrome," specifically referring to it as "Li Jie Feng," "He Xi Feng," and "Wang Bi." The core pathogenesis is attributed to external wind-cold-dampness obstructing the meridians, leading to stagnation of Qi and blood, deficiency of the liver and kidneys, and malnourishment of the tendons and bones.

[0003] Currently, the treatment of rheumatoid arthritis depends primarily on the patient's specific condition, with conventional treatments including medication and surgery. Although there is currently no cure for the disease, early disease control and maintenance therapy can effectively slow its progression and improve patients' quality of life. Existing traditional Chinese medicine formulas for treating rheumatoid arthritis often focus on dispelling wind, cold, and relieving pain, neglecting the pathological characteristics of prolonged illness leading to liver and kidney deficiency and deep-seated blood stasis in the bones; some tonifying formulas lack sufficient blood-activating and meridian-clearing properties, failing to effectively clear deep-seated blood stasis in the joints, thus having limited effectiveness in improving late-stage joint stiffness and bone damage.

[0004] Therefore, developing a traditional Chinese medicine composition with compliant raw materials, stable efficacy, and highly targeted preparation process is of great practical significance. Summary of the Invention

[0005] In view of this, the present invention proposes a traditional Chinese medicine composition for treating rheumatoid arthritis and its preparation method, aiming to solve the problems in the current technology of non-compliant raw materials in the compound formulation of traditional Chinese medicine for rheumatoid arthritis, difficulty in treating the symptoms and not the root cause, limited effect on improving joint and bone quality, and prominent toxic side effects of long-term intervention of Western medicine.

[0006] To achieve the above objectives, the present invention provides the following technical solution: This invention proposes a traditional Chinese medicine composition for treating rheumatoid arthritis and its preparation method, comprising the following components in parts by weight: Ephedra 1.5-12 parts, Clematis chinensis 10-16 parts, Achyranthes bidentata 5-15 parts, Angelica pubescens 3-15 parts, Eucommia ulmoides 6-16 parts, Gastrodia elata 3-12 parts, Cornus officinalis (without pit) 6-12 parts, Morinda officinalis 6-18 parts, Gentiana macrophylla 3-10 parts, Saffron 1.5-4.5 parts, Alpinia oxyphylla 3-12 parts, Ligusticum chuanxiong 3-12 parts, Buthus martensii 3-5 parts, Testudinis plastrum 15-40 parts, Panax notoginseng 3-11 parts, Saposhnikovia divaricata 8-18 parts, Corydalis yanhusuo 3-10 parts, Angelica sinensis 8-16 parts, Curcuma longa 3-12 parts, Cibotium barometz 3-15 parts, Glycyrrhiza uralensis 2.5-15 parts.

[0007] Furthermore, the dosage form of the traditional Chinese medicine composition is a decoction, powder, or pill.

[0008] A method for preparing a traditional Chinese medicine composition for treating rheumatoid arthritis includes the following steps: (1) Crush the tortoise shell beforehand, soak it in water, bring it to a boil over high heat, then reduce to low heat and simmer it separately. (2) Then add the remaining medicinal materials and decoct them together over low heat. After simmering, filter the decoction to obtain the first decoction. (3) Add water to the dregs from the first decoction, decoct all the dregs together over low heat, and then filter to obtain the second decoction. (4) Combine the decoctions from the two decoctions to obtain the Chinese medicine composition.

[0009] Furthermore, in step (1), the amount of water used in the soaking process is 7 to 10 times the total weight of the medicinal materials.

[0010] Furthermore, the soaking time in step (1) is 30-50 minutes, and the decocting time is 30-50 minutes.

[0011] Furthermore, the simmering time in step (2) is 20 to 40 minutes.

[0012] Furthermore, the amount of water added in step (3) is 5 to 8 times the total weight of the medicinal materials.

[0013] Furthermore, the decoction time in step (3) is 15-25 minutes.

[0014] Compared with the prior art, the beneficial effects of the present invention are as follows: This invention differs from single analgesic or single liver and kidney tonifying formulas. It simultaneously dispels wind and cold, unblocks meridians and removes blood stasis, strengthens bones and replenishes deficiencies, and takes into account both reducing swelling and relieving pain in the acute phase and consolidating the body's foundation and preventing recurrence in the remission phase.

[0015] This invention combines scorpion, saffron, and other blood-activating and meridian-clearing herbs, which can penetrate muscles and bones to improve the problems of blood stasis and bone erosion in chronic rheumatoid arthritis. In addition, licorice harmonizes the various herbs and reduces the irritation of insects and blood-activating herbs, making it suitable for long-term and continuous intervention for chronic rheumatoid arthritis without the toxic side effects of Western medicine hormones.

[0016] This invention can be used as a decoction in hospitals, or it can be industrially produced into granules, capsules, and pills for patients to carry and take for a long time.

[0017] The traditional Chinese medicine composition of this invention works synergistically to dispel wind and dampness, promote qi and blood circulation, clear the meridians and relieve pain, tonify the liver and kidneys, and strengthen tendons and bones, precisely addressing the complex pathogenesis of rheumatoid arthritis involving wind-cold-dampness obstruction, blood stasis entering the bones, and liver and kidney deficiency.

[0018] In this invention, the principal herb strengthens the body's foundation, nourishes the liver and kidneys, and repairs bones, addressing the root cause of rheumatoid arthritis. The assistant herb disperses external pathogenic factors, expelling wind, cold, and dampness, quickly relieving joint heaviness, cold pain, and discomfort. The adjuvant herb clears deep-seated blood stasis, removing long-standing blockages in the bone vessels, improving morning stiffness, deformities, and persistent stabbing pain. Licorice root acts as the guiding herb, harmonizing the medicinal properties and protecting the stomach while strengthening the body's foundation. The entire formula nourishes without retaining pathogenic factors, disperses pathogenic factors without harming the body's vital energy, and invigorates blood without depleting it, addressing both the root cause and symptoms. Simultaneously, it improves joint inflammation and pain, reduces bone damage, and lowers the probability of recurrence. Detailed Implementation

[0019] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention. It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the present invention.

[0020] Furthermore, regarding the numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Every smaller range between any stated value or intermediate value within a stated range, and any other stated value or intermediate value within said range, is also included within this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0021] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to this specification are incorporated by way of citation to disclose and describe methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail.

[0022] Various modifications and variations can be made to the specific embodiments described in this specification without departing from the scope or spirit of the invention, as will be apparent to those skilled in the art. Other embodiments derived from this specification will also be apparent to those skilled in the art. This specification and embodiments are merely exemplary.

[0023] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0024] In the above composition, the weight of the medicine is calculated based on the raw medicinal materials, and the proportions are based on weight. During production, the proportions can be increased or decreased proportionally. For example, large-scale production can be measured in kilograms or tons, while small-scale production can be measured in grams or milligrams. The weight can be increased or decreased, but the weight ratio of the raw medicinal materials among the components remains unchanged. The above weight ratios are obtained through scientific screening. For special patients, such as those with severe or mild symptoms, or obese or underweight patients, the proportions of the components can be adjusted accordingly, with increases or decreases not exceeding 100%, without changing the efficacy.

[0025] Unless otherwise specified, "parts" in this invention refer to parts by mass. In the following examples, the raw materials are weighed according to 1 part = 1g.

[0026] In this invention, "raw material" is synonymous with "active pharmaceutical ingredient," referring to the traditional Chinese medicinal materials that enable the invention to exert its active function. These materials include various forms, specifically dried, fresh, raw, processed, or prepared medicinal materials, the whole plant of the medicinal material, the effective parts of the whole plant of the medicinal material, or combinations thereof, but are not limited thereto. In some embodiments, the raw material further comprises the main active ingredients extracted from the raw material, all of which are components proven in the prior art.

[0027] This invention provides a traditional Chinese medicine composition for treating rheumatoid arthritis and its preparation method, comprising the following components in parts by weight: Ephedra 1.5-12 parts, Clematis chinensis 10-16 parts, Achyranthes bidentata 5-15 parts, Angelica pubescens 3-15 parts, Eucommia ulmoides 6-16 parts, Gastrodia elata 3-12 parts, Cornus officinalis (without pit) 6-12 parts, Morinda officinalis 6-18 parts, Gentiana macrophylla 3-10 parts, Saffron 1.5-4.5 parts, Alpinia oxyphylla 3-12 parts, Ligusticum chuanxiong 3-12 parts, Buthus martensii 3-5 parts, Testudinis plastrum 15-40 parts, Panax notoginseng 3-11 parts, Saposhnikovia divaricata 8-18 parts, Corydalis yanhusuo 3-10 parts, Angelica sinensis 8-16 parts, Curcuma longa 3-12 parts, Cibotium barometz 3-15 parts, Glycyrrhiza uralensis 2.5-15 parts.

[0028] In this invention, the dosage form of the traditional Chinese medicine composition is a decoction, powder, or pill.

[0029] In this invention, the principal herbs are tortoise shell, eucommia bark, morinda root, kernelless cornus fruit, alpinia oxyphylla, cibotium barometz, and achyranthes bidentata. Prolonged rheumatism inevitably depletes the essence and blood of the liver and kidneys, leading to malnourishment of the tendons and bones, resulting in joint deformities, bone erosion, and weakness in the lower back and knees. Tortoise shell nourishes yin and replenishes marrow, supplementing the yin essence of the tendons and bones; eucommia bark and morinda root warm and tonify kidney yang, achieving dual yin and yang tonification of the liver and kidneys; cornus fruit consolidates the essence and qi of the liver and kidneys; alpinia oxyphylla warms and nourishes the spleen and kidneys, strengthening the lower back and knees; cibotium barometz has the dual effects of tonifying the liver and kidneys and dispelling wind and dampness; and achyranthes bidentata guides the medicinal power directly to the bones and joints of the limbs. The entire group of principal herbs directly targets the root cause of rheumatoid arthritis, strengthening the body and preventing recurrence.

[0030] In this invention, the assistant herbs are ephedra, clematis, angelica pubescens, gentiana macrophylla, and saposhnikovia divaricata. Ephedra opens the pores and disperses deep-seated cold and dampness; clematis circulates through the twelve meridians and specifically treats stubborn pain throughout the body; angelica pubescens specifically targets obstruction in the waist and lower limbs; gentiana macrophylla dispels wind-dampness and clears chronic heat from deficiency; saposhnikovia divaricata circulates throughout the body, dispelling wind and dampness. These assistant herbs target the invasion of wind, cold, and dampness, which obstruct the meridians and cause joint coldness, swelling, heaviness, and difficulty in flexion and extension. Furthermore, the combination of principal and assistant herbs addresses both the root cause and the symptoms, tonifying deficiency without retaining pathogens, and dispersing pathogens without harming the body's vital energy.

[0031] In this invention, the adjuvant medicine includes blood-activating and collateral-clearing adjuvant medicine and collateral-relieving adjuvant medicine. The blood-activating and collateral-clearing adjuvant medicine is saffron, Panax notoginseng, Ligusticum chuanxiong, Angelica sinensis, Corydalis yanhusuo, Curcuma longa, and scorpion. The insect medicine scorpion has extremely strong penetrating power, clearing away stagnant blood deep in the muscles and bones; saffron and Panax notoginseng break up blood stasis and relieve pain; Ligusticum chuanxiong and Angelica sinensis nourish and activate blood, avoiding damage to blood; Corydalis yanhusuo and Curcuma longa promote qi circulation and relieve depression, and when qi flows, blood stasis will naturally dissipate. The blood-activating and collateral-clearing adjuvant medicine is for chronic arthralgia, where blood stasis stagnates in the bones and meridians, resulting in joint pain and prolonged morning stiffness. The collateral-relieving adjuvant medicine is Gastrodia elata, used to dispel wind and relieve spasms, relax muscle contractures, improve joint stiffness, limb numbness and twitching, and help relieve rheumatoid arthritis spasms.

[0032] In this invention, the adjuvant is licorice. Licorice can harmonize the properties of all the principal, assistant, and adjuvant herbs, and moderate the harshness of the insect and blood-activating herbs in the formula. It can also nourish the spleen and stomach, reduce the stimulation of the gastrointestinal tract by the wind-dispelling and blood-stasis-breaking herbs, and is suitable for long-term use in rheumatoid arthritis. It can also relieve pain and help reduce joint spasms and pain.

[0033] Tortoise shell, in terms of its properties and channels: salty, sweet, and slightly cold; it enters the liver, kidney, and heart channels; it benefits the kidneys and strengthens bones, nourishes yin and replenishes marrow. Prolonged rheumatoid arthritis depletes the yin essence of the liver and kidneys, resulting in malnourishment of the bones; tortoise shell replenishes the yin fluid in the bones, balancing the warming and drying properties of Morinda officinalis, thus achieving a dual tonification of yin and yang in the liver and kidneys.

[0034] Eucommia ulmoides, in terms of its properties and channels: sweet and warm; enters the liver and kidney channels; specifically tonifies the liver and kidneys, strengthens tendons and bones. It improves symptoms such as lower back and knee pain, weakness in the lower limbs, and difficulty walking in rheumatoid arthritis patients; promotes bone tissue repair, and when combined with tortoise shell, enhances its bone-strengthening effects, stabilizing the body's innate constitution.

[0035] Morinda officinalis, in terms of its properties and channels: sweet, pungent, and slightly warm; enters the kidney and liver channels; tonifies kidney yang, dispels cold and dampness, and strengthens tendons and bones. It is indicated for joint pain and swelling that worsens with cold exposure, warming and dispersing cold pathogens deep within the tendons and bones; when combined with Eucommia ulmoides, it warms and tonifies kidney yang, resolving the pathogenesis of arthralgia due to yang deficiency and cold stagnation.

[0036] Cornus officinalis (with pits removed) has the following properties and meridian tropisms: sour, sweet, and slightly warm; it enters the liver and kidney meridians; it tonifies the liver and kidneys, and astringes and consolidates essence. It consolidates the essence and blood of the liver and kidneys, prevents the depletion of yin fluids by warming and tonifying herbs, improves the weakness and fatigue caused by long-term rheumatoid arthritis, and replenishes the qi, blood, and essence consumed by long-term inflammation.

[0037] Alpinia oxyphylla, its properties and channels are: pungent and warm; it enters the spleen and kidney channels; it warms the kidneys and spleen, and strengthens the waist and knees. It nourishes both the spleen and kidneys, and when the spleen and stomach function well, qi and blood are sufficient to nourish the tendons and bones; it improves arthralgia accompanied by aversion to cold and cold limbs, and helps the generation of acquired qi and blood.

[0038] Cibotium barometz, in terms of its properties and meridian tropism: bitter, sweet, and warm; it enters the liver and kidney meridians; it has the dual effects of tonifying the liver and kidneys and dispelling wind and dampness, strengthening the body's foundation without retaining pathogens. It relieves stiffness and heaviness in the spine, limbs, and joints, removes cold and dampness attached to the superficial layers of muscles and bones, and is suitable for joint obstruction in many parts of the body.

[0039] Achyranthes bidentata, in terms of its properties and channels: bitter, sweet, sour, and neutral; enters the liver and kidney channels; tonifies the liver and kidneys, removes blood stasis and unblocks the channels, and guides the medicine downwards. It guides the entire formula's medicinal power directly to the diseased joints of the limbs and lower extremities; it also has the effect of promoting blood circulation, taking into account both tonifying deficiency and unblocking the channels, and is specifically used to improve symmetrical joint swelling and pain in the lower extremities.

[0040] Ephedra, in terms of its properties and channels: pungent, slightly bitter, and warm; it enters the lung and bladder channels; it disperses cold and dampness and promotes joint mobility. It opens the pores and releases wind-cold-dampness pathogens deep within the meridians and joints, relieving joint pain, heaviness, and stiffness. The herbal composition described in this invention uses a mild formula and is combined with tonifying herbs to disperse pathogens without depleting the body's vital energy.

[0041] Clematis chinensis, its properties and channels: pungent, salty, warm; enters the bladder channel; it circulates through the twelve meridians, dispels wind and dampness, and relieves stiffness. It unblocks obstructed meridians throughout the body, improves migratory joint pain and prolonged morning stiffness, loosens adhesions in the tendons and ligaments, and is specifically used to treat stubborn pain and numbness throughout the body.

[0042] Angelica pubescens, in terms of its properties and meridian tropism: pungent, bitter, and slightly warm; it enters the kidney and bladder meridians; it specifically targets the lower abdomen, waist, knees, and lower limbs, dispelling wind, eliminating dampness, and relieving pain. It specifically improves typical symmetrical joint swelling and limited flexion and extension in the lower limbs characteristic of rheumatoid arthritis, and when combined with Clematis chinensis, it achieves simultaneous unblocking of the upper and lower meridians.

[0043] Gentian root, in terms of its properties and channels: pungent, bitter, and neutral; it enters the liver and gallbladder channels; it can dispel wind-dampness and clear away chronic heat due to deficiency. Its mild and non-drying nature neutralizes the warming and drying effects of ephedra and morinda root; it is suitable for chronic arthralgia with stagnant heat, dull joint pain, and mild redness and swelling, preventing the aggravation of joint inflammation induced by warming and drying drugs.

[0044] Fangfeng (Saposhnikovia divaricata), its properties and channels are: pungent, sweet, and slightly warm; it enters the bladder and spleen channels; it can dispel wind and dampness, relax muscles and relieve spasms. It can dispel wind and dampness pathogens throughout the body, moderate the strong dispersing power of ephedra, and reduce joint contractures and numbness.

[0045] Scorpion, in terms of its properties and meridian tropism: pungent, neutral; enters the liver meridian; clears the meridians, breaks up blood stasis, and eliminates latent pathogens. Herbal medicines are difficult to penetrate deep into the bones, but scorpion has extremely strong penetrating power, dissolving years of stagnant blood, improving the stubborn stinging pain of severe rheumatoid arthritis, joint deformities and stiffness, and clearing deep blood stasis in the meridians.

[0046] Saffron, in terms of its properties and meridian tropism: sweet and neutral; enters the heart and liver meridians; it can powerfully promote blood circulation, remove blood stasis, reduce swelling, and relieve pain. It dilates local microvessels in joints, accelerates the excretion of inflammatory metabolic waste, reduces synovial congestion and swelling, and alleviates fixed and stabbing pain in joints.

[0047] Panax notoginseng, in terms of its properties and channels: sweet, slightly bitter, and warm; it enters the liver and stomach channels; it disperses blood stasis and reduces swelling, and promotes blood circulation without harming new blood. It improves micro-bleeding of the synovium, joint swelling and tenderness, and also addresses the chronic bleeding problem of rheumatoid synovium, resolving blood stasis without depleting blood.

[0048] Chuanxiong (Ligusticum striatum), in terms of its properties and channels: pungent and warm; enters the liver and pericardium channels; a qi-regulating herb in the blood, it invigorates blood and promotes qi circulation. When qi flows, blood flows, clearing blockages in qi and blood throughout the body, relieving migratory joint pain, and helping other blood-activating herbs to circulate throughout the body's meridians.

[0049] Angelica sinensis, in terms of its properties and channels: sweet, pungent, and warm; enters the liver and spleen channels; nourishes and invigorates blood, and moistens tendons and vessels. The formula contains a large number of blood-activating and stasis-removing herbs that can easily deplete yin and blood. Angelica sinensis nourishes and strengthens the blood, activating blood without harming it, thus improving numbness in the limbs and loss of nourishment in tendons and vessels caused by prolonged illness.

[0050] Corydalis rhizome, in terms of its properties and channels: pungent, bitter, and warm; it enters the liver and spleen channels; it promotes qi and blood circulation and has a strong analgesic effect. It directly relieves various types of joint pain in both the acute and stable phases of rheumatoid arthritis, specifically targeting persistent joint pain caused by qi and blood stagnation.

[0051] Turmeric, in terms of its properties and channels: pungent, bitter, and cold; enters the liver and heart channels; it promotes qi circulation, relieves stagnation, invigorates blood, and alleviates pain. In cases of chronic arthralgia where qi is stagnant and blood stasis is difficult to resolve, turmeric can soothe liver qi, relieve joint swelling and pain accompanied by chest tightness and depression, and aid in the flow of qi and blood.

[0052] Gastrodia elata, in terms of its properties and channels: sweet and neutral; enters the liver channel; it calms wind, unblocks the channels, and relieves muscle spasms. It can alleviate morning stiffness, joint spasms, limb twitching and numbness caused by rheumatoid arthritis, and reduce symptoms of muscle tightness and difficulty in bending and stretching.

[0053] Licorice, in terms of its properties and channels: sweet, neutral; enters the heart, spleen, and stomach channels; licorice can moderate the warming and drying properties of ephedra, angelica pubescens, and morinda officinalis, the cold properties of turmeric and tortoise shell, and the strong stimulation of scorpion and insect medicines, thus balancing the cold and hot properties of various medicines; it can also reduce the damage to the gastrointestinal tract caused by blood-activating, wind-dispelling, and insect-based medicines, making it suitable for long-term oral administration in patients with chronic rheumatoid arthritis; it can also help relieve joint contractures and pain; it tonifies the spleen and stomach, enhances the production of qi and blood, and indirectly nourishes the liver, kidneys, tendons, and bones.

[0054] In this invention, the principal herb strengthens the body's foundation, nourishes the liver and kidneys, and repairs bones, addressing the root cause of rheumatoid arthritis. The assistant herb disperses the symptoms, expelling external wind-cold-dampness pathogens and quickly relieving joint heaviness, cold pain, and discomfort. The adjuvant herb clears deep-seated blood stasis, removes long-standing blood stasis in the bone vessels, and improves morning stiffness, deformities, and persistent stabbing pain. Licorice is used as the guiding herb to harmonize the medicinal properties, protect the stomach, and strengthen the body's foundation. The entire formula nourishes without retaining pathogens, disperses pathogens without harming the body's vital energy, and invigorates blood without depleting it, addressing both the root cause and symptoms. It simultaneously improves joint inflammation and pain, as well as bone damage, reducing the probability of recurrence.

[0055] A method for preparing a traditional Chinese medicine composition for treating rheumatoid arthritis includes the following steps: (1) Crush the tortoise shell beforehand, soak it in water, bring it to a boil over high heat, then reduce to low heat and simmer it separately. (2) Then add the remaining medicinal materials and decoct them together over low heat. After simmering, filter the decoction to obtain the first decoction. (3) Add water to the dregs from the first decoction, decoct all the dregs together over low heat, and then filter to obtain the second decoction. (4) Combine the decoctions from the two decoctions to obtain the Chinese medicine composition.

[0056] In this invention, the amount of water used in the soaking step (1) is preferably 7 to 10 times the total weight of the medicinal materials, and more preferably 8 to 10 times the total weight of the medicinal materials.

[0057] In this invention, the soaking time in step (1) is preferably 30-50 min, more preferably 35-50 min; the decocting time is preferably 30-50 min, more preferably 30-45 min.

[0058] In this invention, the simmering time in step (2) is preferably 20 to 40 minutes, and more preferably 25 to 40 minutes.

[0059] In this invention, the amount of water added in step (3) is preferably 5 to 8 times the total weight of the medicinal materials, and more preferably 5 to 7 times the total weight of the medicinal materials.

[0060] In this invention, the decoction time in step (3) is preferably 15-25 min, and more preferably 18-25 min.

[0061] In this invention, unless otherwise specified, all raw materials required for preparation are commercially available products well known to those skilled in the art.

[0062] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0063] Example 1 Ingredients: Ephedra 1.5g, Clematis chinensis 10g, Achyranthes bidentata 5g, Angelica pubescens 3g, Eucommia ulmoides 6g, Gastrodia elata 3g, Cornus officinalis (without pit) 6g, Morinda officinalis 6g, Gentiana macrophylla 3g, Saffron 1.5g, Alpinia oxyphylla 3g, Ligusticum chuanxiong 3g, Buthus martensii 3g, Testudinis plastrum 15g, Panax notoginseng 3g, Saposhnikovia divaricata 8g, Corydalis yanhusuo 3g, Angelica sinensis 8g, Curcuma longa 3g, Cibotium barometz 3g, Glycyrrhiza uralensis 2.5g.

[0064] Preparation method: (1) Crush the tortoise shell beforehand, add water equal to 8 times the total weight of the medicinal materials and soak for 35 minutes. Bring to a boil over high heat, then reduce to low heat and decoct separately for 30 minutes. (2) Then add the remaining medicinal materials and decoct for 25 minutes. After simmering over low heat, filter to obtain the first decoction. (3) Add water five times the total weight of the medicinal materials to the dregs from the first decoction, simmer all the dregs over low heat for 18 minutes, and then filter to obtain the second decoction. (4) Combine the decoctions from the two decoctions to obtain the Chinese medicine composition.

[0065] Example 2 Ingredients: Ephedra 6g, Clematis chinensis 13g, Achyranthes bidentata 10g, Angelica pubescens 9g, Eucommia ulmoides 11g, Gastrodia elata 7g, Cornus officinalis (without pit) 9g, Morinda officinalis 12g, Gentiana macrophylla 6g, Saffron 3g, Alpinia oxyphylla 7g, Ligusticum chuanxiong 8g, Buthus martensii 4g, Testudinis plastrum 28g, Panax notoginseng 7g, Saposhnikovia divaricata 13g, Corydalis yanhusuo 6g, Angelica sinensis 12g, Curcuma longa 8g, Cibotium barometz 9g, Glycyrrhiza uralensis 9g.

[0066] (1) Crush the tortoise shell beforehand, add water equal to 9 times the total weight of the medicinal materials and soak for 40 minutes. Bring to a boil over high heat, then reduce to low heat and decoct separately for 40 minutes. (2) Then add the remaining medicinal materials and decoct for 30 minutes. After simmering over low heat, filter to obtain the first decoction. (3) Add water equal to 6 times the total weight of the medicinal materials to the dregs from the first decoction, simmer all the dregs over low heat for 20 minutes, and then filter to obtain the second decoction. (4) Combine the decoctions from the two decoctions to obtain the Chinese medicine composition.

[0067] Example 3 Ingredients: Ephedra 12g, Clematis chinensis 16g, Achyranthes bidentata 15g, Angelica pubescens 15g, Eucommia ulmoides 16g, Gastrodia elata 12g, Cornus officinalis (without pit) 12g, Morinda officinalis 18g, Gentiana macrophylla 10g, Saffron 4.5g, Alpinia oxyphylla 12g, Ligusticum chuanxiong 12g, Buthus martensii 5g, Testudinis plastrum 40g, Panax notoginseng 11g, Saposhnikovia divaricata 18g, Corydalis yanhusuo 10g, Angelica sinensis 16g, Curcuma longa 12g, Cibotium barometz 15g, Glycyrrhiza uralensis 15g.

[0068] (1) Crush the tortoise shell beforehand, add water equal to 10 times the total weight of the medicinal materials and soak for 50 minutes. Bring to a boil over high heat, then reduce to low heat and decoct separately for 45 minutes. (2) Then add the remaining medicinal materials and decoct for 40 minutes. After simmering over low heat, filter to obtain the first decoction. (3) Add water equal to 7 times the total weight of the medicinal materials to the dregs from the first decoction, simmer all the dregs over low heat for 25 minutes, and then filter to obtain the second decoction. (4) Combine the decoctions from the two decoctions to obtain the Chinese medicine composition.

[0069] Performance testing: (a) In vitro cell anti-inflammatory test An inflammation model was established using lipopolysaccharide (LPS) to induce RAW264.7 rat macrophages. The rats were treated with the solutions described in Examples 1, 2, and 3, respectively. The secretion levels of inflammatory factors TNF-α, IL-1β, and IL-6 were measured. The anti-inflammatory performance results of Examples 1-3 are shown in Table 1 below. Table 1. Anti-inflammatory results of rat cells in in vitro after administration of Examples 1-3 According to the in vitro cell anti-inflammatory results in rats in Table 1, after administration of the traditional Chinese medicine composition of Example 1, the secretion of inflammatory factors in rat in vitro cells decreased by 38.2%~45.7%, exhibiting a mild anti-inflammatory effect; after administration of the traditional Chinese medicine composition of Example 2, the secretion of inflammatory factors decreased by 72.5%~79.1%, showing a significant inhibitory effect on pro-inflammatory factors; after administration of the traditional Chinese medicine composition of Example 3, the secretion of inflammatory factors in rat in vitro cells decreased by 81.3%~86.6%, exhibiting the best anti-inflammatory strength; therefore, the three groups of drug solutions in Examples 1-3 prepared using the raw materials and methods described in this invention can all inhibit the release of key pro-inflammatory factors in rheumatoid arthritis from macrophages, and the efficacy increases with increasing dosage.

[0070] (II) Animal model experiment of rat arthritis Rheumatoid arthritis animal models were induced in male SD rats using Freund's complete adjuvant and divided into a model control group, drug administration groups of Examples 1, 2, and 3, and a positive drug (methotrexate) control group. The rats were administered the drugs by gavage for 28 consecutive days. The following indicators were measured: paw swelling, joint pathology score, serum inflammatory markers, and bone repair effect.

[0071] The performance test results of the traditional Chinese medicine compositions in the administration examples 1-3 are shown in Table 2 below. Table 2 Performance test results of the traditional Chinese medicine compositions in Examples 1-3. According to the results of the rat arthritis animal model test of the traditional Chinese medicine compositions of Examples 1-3 in Table 2, it can be seen that the traditional Chinese medicine composition prepared in Example 2 of this invention has a balanced efficacy and safety, the high-dose traditional Chinese medicine composition in Example 3 has the strongest anti-inflammatory and bone repair effects, and the low-dose traditional Chinese medicine composition in Example 1 is suitable for early intervention in mild cases.

[0072] (III) Clinical observation of human efficacy 120 patients who met the diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Rheumatoid Arthritis" and were diagnosed with liver and kidney deficiency and cold-dampness stagnation were selected. In terms of age, the oldest patient was 75 years old, the youngest patient was 34 years old, and the median age was 62 years old. In terms of gender, there were 78 female patients and 42 male patients. They were randomly divided into 3 groups and took the decoctions of Example 1, 2, and 3 respectively, one dose per day, for 30 consecutive days. The efficacy criteria are as follows: Cure: Joint swelling and pain and morning stiffness completely disappear, erythrocyte sedimentation rate and CRP return to normal, and joint movement is not restricted; Significant effect: Joint swelling and pain subside ≥70%, morning stiffness time <15min, and inflammatory indicators decrease significantly; Effective: Joint swelling and pain subside 30%~70%, and morning stiffness is significantly shortened; Ineffective: Symptoms and laboratory indicators do not improve or even worsen.

[0073] The clinical efficacy results of the patients taking the traditional Chinese medicine compositions described in Examples 1-3 are shown in Table 3 below. Table 3. Clinical efficacy results of patients taking the traditional Chinese medicine compositions described in Examples 1-3 According to the clinical efficacy observation results in Table 3, the traditional Chinese medicine compositions described in Examples 1-3 of this invention can improve symptoms of liver and kidney deficiency such as soreness and weakness of the waist and knees, aversion to cold and cold limbs, and fatigue. The higher the dosage, the more prominent the effect of tonifying deficiency and strengthening muscles.

[0074] (iv) Acute toxicity safety testing Acute toxicity tests at maximum dose were conducted on mice. The herbal compositions prepared in Examples 1-3 were concentrated and administered by gavage once at a dose 25 times the clinical adult dose, and the mice were observed for 7 consecutive days.

[0075] The acute toxicity safety test results of Examples 1-3 are shown in Table 4 below. Table 4. Acute toxicity safety test results of Examples 1-3 According to the acute toxicity and safety test results in Table 4, the traditional Chinese medicine composition of the present invention is safe and non-toxic, has good long-term oral tolerance, and is suitable for long-term continuous treatment of chronic rheumatoid arthritis.

[0076] In summary, the low-dose example 1 of this invention is suitable for early-stage mild cases; the medium-dose example 2 balances efficacy and mildness, making it the first choice in clinical practice; the high-dose example 3 is for patients with severe joint deformities and bone destruction; the traditional Chinese medicine composition prepared using the raw materials described in this invention has multiple effects, including inhibiting inflammatory factors in vitro, reducing swelling and relieving pain in vivo, repairing damaged bones and joints, regulating the body's immunity, and tonifying the liver and kidneys. It is highly safe and has no side effects such as hormones, immunosuppressants, or liver, kidney, or bone marrow suppression.

[0077] The above embodiments are merely preferred embodiments of the present invention and are not intended to limit the present invention. The scope of protection of the present invention is determined by the appended claims.

[0078] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that modifications or equivalent substitutions can still be made to the specific implementation of the present invention. Any modifications or equivalent substitutions that do not depart from the spirit and scope of the present invention should be covered within the scope of protection of the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for treating rheumatoid arthritis, characterized in that, The components comprise the following parts by weight: Ephedra 1.5-12 parts, Clematis chinensis 10-16 parts, Achyranthes bidentata 5-15 parts, Angelica pubescens 3-15 parts, Eucommia ulmoides 6-16 parts, Gastrodia elata 3-12 parts, Cornus officinalis (without pit) 6-12 parts, Morinda officinalis 6-18 parts, Gentiana macrophylla 3-10 parts, Saffron 1.5-4.5 parts, Alpinia oxyphylla 3-12 parts, Ligusticum chuanxiong 3-12 parts, Buthus martensii 3-5 parts, Testudinis plastrum 15-40 parts, Panax notoginseng 3-11 parts, Saposhnikovia divaricata 8-18 parts, Corydalis yanhusuo 3-10 parts, Angelica sinensis 8-16 parts, Curcuma longa 3-12 parts, Cibotium barometz 3-15 parts, Glycyrrhiza uralensis 2.5-15 parts.

2. The traditional Chinese medicine composition for treating rheumatoid arthritis according to claim 1, characterized in that, The dosage form of the traditional Chinese medicine composition is decoction, powder, or pill.

3. A method for preparing a traditional Chinese medicine composition for treating rheumatoid arthritis as described in any one of claims 1-2, characterized in that, Includes the following steps: (1) Crush the tortoise shell beforehand, soak it in water, bring it to a boil over high heat, then reduce to low heat and simmer it separately. (2) Then add the remaining medicinal materials and decoct them together over low heat. After simmering, filter the decoction to obtain the first decoction. (3) Add water to the dregs from the first decoction, decoct all the dregs together over low heat, and then filter to obtain the second decoction. (4) Combine the decoctions from the two decoctions to obtain the Chinese medicine composition.

4. The method for preparing a traditional Chinese medicine composition for treating rheumatoid arthritis according to claim 3, characterized in that, In step (1), the amount of water used in soaking the medicinal materials is 7 to 10 times the total weight of the medicinal materials.

5. A method for preparing a traditional Chinese medicine composition for treating rheumatoid arthritis according to claim 3, characterized in that, The soaking time in step (1) is 30-50 minutes, and the decocting time is 30-50 minutes.

6. A method for preparing a traditional Chinese medicine composition for treating rheumatoid arthritis according to claim 3, characterized in that, The simmering time in step (2) is 20-40 minutes.

7. A method for preparing a traditional Chinese medicine composition for treating rheumatoid arthritis according to claim 3, characterized in that, The amount of water added in step (3) is 5 to 8 times the total weight of the medicinal materials.

8. A method for preparing a traditional Chinese medicine composition for treating rheumatoid arthritis according to claim 3, characterized in that, The decoction time mentioned in step (3) is 15~25 minutes.

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