Traditional Chinese medicine composition for treating rheumatoid arthritis as well as preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating rheumatoid arthritis as well as a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 70 to 130 parts of radix angelicae pubescentis, 70 to 130 parts of rhizoma seu radix notopterygii, 70 to 130 parts of radix stephaniae tetrandrae, 170 to 230 parts of herba siegesbeckiae, 130 to 170 parts of rhizoma atractylodis, 70 to 130 parts of cortex phellodendri, 170 to 230 parts of semen coicis, 70 to 130 parts of herba plantaginis, 70 to 130 parts of tetrapanax papyriferus, 70 to 130 parts of radix achyranthis bidentatae and 260 to 340 parts of ramulus mori. The traditional Chinese medicine composition can effectively solve the problems of large side effect, limited treatment effect and relapse after drug withdrawal of the existing medicine.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine preparation, and particularly relates to a traditional Chinese medicine composition for treating rheumatoid arthritis, its preparation method and application. Background Art

[0002] Rheumatoid arthritis (RA) is a chronic, inflammatory, systemic autoimmune disease with unknown etiology. Its main clinical manifestations are symmetric, progressive and erosive polysynovitis and extra-articular lesions of chronic, systemic autoimmune inflammatory diseases. The etiology of this disease has not been fully clarified, and it is generally believed that genetic and environmental factors are closely related to its onset.

[0003] At present, the drugs used to treat RA clinically mainly include disease-modifying antirheumatic drugs, non-steroidal anti-inflammatory drugs, steroid hormones, and biological agents. However, the side effects caused by long-term use of these drugs, such as gastrointestinal reactions, liver and kidney dysfunction, and other systemic toxicities caused by free drugs entering the systemic circulation, limit their clinical applications. There are also some proprietary Chinese medicines on the market, but most of them have limited therapeutic effects. Summary of the Invention

[0004] In view of the above deficiencies in the prior art, the present invention provides a traditional Chinese medicine composition for treating rheumatoid arthritis, its preparation method and application. This traditional Chinese medicine composition can effectively solve the problems of large side effects, limited therapeutic effects, and recurrence after drug withdrawal existing in existing drugs.

[0005] To achieve the above object, the technical solution adopted by the present invention to solve its technical problems is:

[0006] A traditional Chinese medicine composition for treating rheumatoid arthritis, comprising the following components in parts by weight: 70 - 130 parts of Heracleum hemsleyanum, 70 - 130 parts of Notopterygium incisum, 70 - 130 parts of Stephania tetrandra, 170 - 230 parts of Siegesbeckia orientalis, 130 - 170 parts of Atractylodes lancea, 70 - 130 parts of Phellodendron amurense, 170 - 230 parts of Coix lacryma-jobi, 70 - 130 parts of Plantago asiatica, 70 - 130 parts of Tetrapanax papyriferus, 70 - 130 parts of Achyranthes bidentata, and 260 - 340 parts of Ramulus mori.

[0007] Further, it comprises the following components in parts by weight: 90 - 110 parts of Heracleum hemsleyanum, 90 - 110 parts of Notopterygium incisum, 90 - 110 parts of Stephania tetrandra, 180 - 210 parts of Siegesbeckia orientalis, 140 - 160 parts of Atractylodes lancea, 90 - 110 parts of Phellodendron amurense, 180 - 210 parts of Coix lacryma-jobi, 90 - 110 parts of Plantago asiatica, 90 - 110 parts of Tetrapanax papyriferus, 90 - 110 parts of Achyranthes bidentata, and 280 - 310 parts of Ramulus mori.

[0008] Furthermore, it includes the following components in parts by weight: 90 parts of Angelica pubescens, 110 parts of Notopterygium incisum, 110 parts of Stephania tetrandra, 210 parts of Siegesbeckia orientalis, 160 parts of Atractylodes lancea, 110 parts of Phellodendron amurense, 180 parts of Coix lacryma-jobi, 90 parts of Plantago asiatica, 90 parts of Tetrapanax papyriferus, 110 parts of Achyranthes bidentata, and 310 parts of Ramulus mori.

[0009] Furthermore, it includes the following components in parts by weight: 110 parts of Angelica pubescens, 90 parts of Notopterygium incisum, 90 parts of Stephania tetrandra, 180 parts of Siegesbeckia orientalis, 140 parts of Atractylodes lancea, 90 parts of Phellodendron amurense, 210 parts of Coix lacryma-jobi, 110 parts of Plantago asiatica, 110 parts of Tetrapanax papyriferus, 90 parts of Achyranthes bidentata, and 280 parts of Ramulus mori.

[0010] Furthermore, it includes the following components in parts by weight: 100 parts of Angelica pubescens, 100 parts of Notopterygium incisum, 100 parts of Stephania tetrandra, 200 parts of Siegesbeckia orientalis, 150 parts of Atractylodes lancea, 100 parts of Phellodendron amurense, 200 parts of Coix lacryma-jobi, 100 parts of Plantago asiatica, 100 parts of Tetrapanax papyriferus, 100 parts of Achyranthes bidentata, and 300 parts of Ramulus mori.

[0011] Furthermore, the Siegesbeckia orientalis is the stir-fried Siegesbeckia orientalis with wine, the Atractylodes lancea is the stir-fried Atractylodes lancea with bran, the Phellodendron amurense is the salted Phellodendron amurense, the Achyranthes bidentata is the stir-fried Achyranthes bidentata with wine, and the Ramulus mori is the stir-fried Ramulus mori.

[0012] The preparation method of the above traditional Chinese medicine composition for treating rheumatoid arthritis includes mixing after pulverizing each raw material drug; or making it from the extracts obtained by mixing or separately extracting each raw material drug; or making it from the active ingredients obtained by further refining and purifying the extracts; or making it by adding pharmaceutically acceptable excipients to the extracts / active ingredients.

[0013] Furthermore, the dosage form prepared is one of pills, granules, capsules, powders, mixtures or oral liquids.

[0014] Furthermore, the specific preparation method is as follows: The above nine flavors are decocted with water, the decoction is filtered, the filtrates are combined, and concentrated under reduced pressure to a clear paste with a relative density of 1.15 - 1.25, and granulated with pharmaceutically acceptable excipients to obtain.

[0015] The application of the above traditional Chinese medicine composition in the preparation of drugs for treating rheumatoid arthritis.

[0016] The beneficial effects produced by the present invention are:

[0017] In the formula, Angelica pubescens is pungent, bitter, slightly warm, and is good at dispelling wind-cold-damp pathogens in the lower energizer and relieving pain due to arthralgia, and is the monarch drug.

[0018] Notopterygium incisum is pungent, bitter, warm, enters the Taiyang meridian, disperses exterior wind-cold-dampness, promotes joint movement and relieves pain due to arthralgia, and is the key drug for treating wind-cold-damp pathogens in the exterior; when damp pathogen is relatively excessive, Stephania tetrandra is added to promote diuresis and reduce swelling; stir-fried Siegesbeckia orientalis with wine is bitter, pungent, warm, and belongs to the liver and kidney meridians, dispels wind-dampness, dredges channels and collaterals, and strengthens tendons and bones; the above are all ministerial drugs, which can assist the monarch drug to fundamentally improve the patient's constitution and achieve the therapeutic effect.

[0019] Salt-processed Phellodendron amurense Rupr. is bitter and cold, and enters the kidney, bladder, and large intestine meridians. It clears heat and dries dampness, purges fire and detoxifies, and reduces fever and eliminates steaming. Taking advantage of its cold nature to overcome heat and bitter nature to dry dampness, when combined with Stephania tetrandra S. Moore, it enhances the effect of drying dampness. Moreover, salt processing is good at dispelling dampness and heat in the lower energizer. Since dampness originates from the spleen, stir-fried Atractylodes lancea (Thunb.) DC. with bran is used to dry dampness and strengthen the spleen, so that damp pathogens are removed and will not regenerate. Stir-fried Atractylodes lancea (Thunb.) DC. with bran is pungent, bitter, warm, and drying, and enters the spleen and stomach meridians. It dries dampness and strengthens the spleen, dispels wind-dampness, and can induce sweating to remove dampness, and also assist Notopterygium incisum Ting ex H. T. Chang in dispersing cold and removing dampness to relieve pain. The combination of these two herbs clears the source and takes into account both the root and the branch, so that dampness and heat are removed and all symptoms are resolved. Coix seed is added to promote diuresis and reduce turbidity, and promote diuresis and relax tendons. Plantago asiatica L. is sweet and cold, and enters the liver, kidney, lung, and small intestine meridians. It promotes diuresis, clears heat, clears the liver and improves eyesight, and reduces phlegm. Tetrapanax papyrifer (Hook.) K. Koch is sweet and light in taste and slightly cold in nature, and enters the lung and stomach meridians. It purges the lung, clears heat and promotes diuresis, and promotes qi circulation. All of the above are adjuvant herbs. Cyathula officinalis Kuan processed with wine is bitter, sweet, sour, and neutral, and enters the liver and kidney meridians. It promotes blood circulation and dredges the meridian, tonifies the liver and kidney, strengthens the bones and muscles, promotes diuresis and removes stranguria, and guides fire (blood) downward. It is biased towards promoting blood circulation to remove blood stasis, and can also tonify the liver and kidney, dispel wind-dampness, and guide the herbs downward. Stir-fried Ramulus Mori is bitter and neutral, and enters the liver meridian. It dispels wind and dredges collaterals, benefits joints, can dispel wind-dampness, benefit joints, promote the flow of qi and water, and guide the herbs upward. It is especially good at reaching the upper limbs. All of the above are envoy herbs. The compatibility feature of this formula is mainly using herbs that dispel wind-cold-dampness, supplemented by herbs that tonify the liver and kidney, clear heat and promote diuresis. It takes into account both the pathogen and the healthy qi, and balances cold and heat. It means that eliminating pathogens does not damage the healthy qi, and strengthening the healthy qi does not hinder the elimination of pathogens. The combination of all herbs makes the wind-cold-dampness and stagnant heat pathogens all removed, the qi and blood sufficient, the liver and kidney strong, and the arthralgia relieved. Detailed implementation manners

[0020] In order to make the objectives, technical solutions and advantages of the present invention clearer and more understandable, the following further details the present invention in combination with embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention, and are not used to limit the present invention. That is, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments.

[0021] Therefore, the following detailed description of the provided embodiments of the present invention is not intended to limit the scope of the claimed present invention, but only represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative efforts belong to the scope of protection of the present invention.

[0022] It should be noted that relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprising", "including" or any other variant thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device comprising a series of elements not only includes those elements, but also includes other elements not expressly listed, or also includes elements inherent in such process, method, article or device. Without further limitation, an element defined by the statement "comprising one..." does not exclude the existence of additional identical elements in the process, method, article or device comprising the element.

[0023] The features and properties of the present invention will be further described in detail below in conjunction with embodiments.

[0024] Example 1

[0025] A traditional Chinese medicine composition for treating rheumatoid arthritis is made from the following components in parts by weight: 70 g of Heracleum hemsleyanum, 130 g of Notopterygium incisum, 130 g of Stephania tetrandra, 230 g of Siegesbeckia orientalis L. var. pubescens, 170 g of Atractylodes lancea (Thunb.) DC. stir-fried with bran, 130 g of Phellodendron amurense Rupr. salted, 170 g of Coix lacryma-jobi L., 70 g of Plantago asiatica L., 70 g of Tetrapanax papyrifer (Hook.) K. Koch, 130 g of Cyathula officinalis Kuan stir-fried with wine and 340 g of Ramulus Mori stir-fried.

[0026] The preparation method of the above traditional Chinese medicine composition for treating rheumatoid arthritis comprises the following steps: The above eleven flavors are decocted with water three times. For the first time, 11 times the amount of water is added, and for the second and third times, 8 times the amount of water is added. Each decoction is for 1 hour. The decoction liquid is filtered, and the filtrates are combined. The filtrate is concentrated to a clear paste with a relative density of 1.15 (60 °C), an appropriate amount of dextrin is added, granulated, mixed, and 1000 g is made, thus obtaining.

[0027] Example 2

[0028] A traditional Chinese medicine composition for treating rheumatoid arthritis is made from the following components in parts by weight: 130 g of Heracleum hemsleyanum, 70 g of Notopterygium incisum, 70 g of Stephania tetrandra, 170 g of Siegesbeckia orientalis L. var. pubescens, 130 g of Atractylodes lancea (Thunb.) DC. stir-fried with bran, 70 g of Phellodendron amurense Rupr. salted, 230 g of Coix lacryma-jobi L., 130 g of Plantago asiatica L., 130 g of Tetrapanax papyrifer (Hook.) K. Koch, 70 g of Cyathula officinalis Kuan stir-fried with wine and 260 g of Ramulus Mori stir-fried.

[0029] The preparation method of the above traditional Chinese medicine composition for treating rheumatoid arthritis comprises the following steps: The above eleven flavors are decocted with water three times. For the first time, 11 times the amount of water is added, and for the second and third times, 8 times the amount of water is added. Each decoction is for 1 hour. The decoction liquid is filtered, and the filtrates are combined. The filtrate is concentrated to a clear paste with a relative density of 1.25 (60 °C), an appropriate amount of dextrin is added, granulated, mixed, and 1000 g is made, thus obtaining.

[0030] Example 3

[0031] A traditional Chinese medicine composition for treating rheumatoid arthritis is prepared from the following components in parts by weight: 95 g of Heracleum hemsleyanum Diels, 115 g of Notopterygium incisum Ting ex H. T. Chang, 115 g of Stephania tetrandra S. Moore, 190 g of Siegesbeckia orientalis L. var. pubescens Makino, 160 g of Atractylodes lancea (Thunb.) DC. stir-fried with bran, 115 g of Phellodendron amurense Rupr. salted, 190 g of Coix lacryma-jobi L. var. ma-yuen (Roman.) Stapf, 120 g of Plantago asiatica L., 120 g of Tetrapanax papyrifer (Hook.) K. Koch, 80 g of Cyathula officinalis Kuan stir-fried with wine and 280 g of Ramulus Mori stir-fried.

[0032] The preparation method of the above traditional Chinese medicine composition for treating rheumatoid arthritis comprises the following steps: The above eleven flavors are decocted with water three times. For the first time, 11 times the amount of water is added, and for the second and third times, 8 times the amount of water is added. Each decoction is for 1 hour. The decoction liquid is filtered, and the filtrates are combined. The filtrate is concentrated to a clear paste with a relative density of 1.25 (60 °C), an appropriate amount of dextrin is added, granulated, and mixed to make 1000 g, thus obtaining.

[0033] Example 4

[0034] A traditional Chinese medicine composition for treating rheumatoid arthritis is prepared from the following components in parts by weight: 90 parts of Heracleum hemsleyanum Diels, 110 parts of Notopterygium incisum Ting ex H. T. Chang, 110 parts of Stephania tetrandra S. Moore, 210 parts of Siegesbeckia orientalis L. var. pubescens Makino, 160 parts of Atractylodes lancea (Thunb.) DC. stir-fried with bran, 110 parts of Phellodendron amurense Rupr. salted, 180 parts of Coix lacryma-jobi L. var. ma-yuen (Roman.) Stapf, 90 parts of Plantago asiatica L., 90 parts of Tetrapanax papyrifer (Hook.) K. Koch, 110 parts of Cyathula officinalis Kuan stir-fried with wine and 310 parts of Ramulus Mori stir-fried.

[0035] The preparation method of the above traditional Chinese medicine composition for treating rheumatoid arthritis comprises the following steps: The above eleven flavors are decocted with water three times. For the first time, 11 times the amount of water is added, and for the second and third times, 8 times the amount of water is added. Each decoction is for 1 hour. The decoction liquid is filtered, and the filtrates are combined. The filtrate is concentrated to a clear paste with a relative density of 1.15 (60 °C), an appropriate amount of dextrin is added, granulated, and mixed to make 1000 g, thus obtaining.

[0036] Example 5

[0037] A traditional Chinese medicine composition for treating rheumatoid arthritis is prepared from the following components in parts by weight: 110 parts of Heracleum hemsleyanum Diels, 90 parts of Notopterygium incisum Ting ex H. T. Chang, 90 parts of Stephania tetrandra S. Moore, 180 parts of Siegesbeckia orientalis L. var. pubescens Makino, 140 parts of Atractylodes lancea (Thunb.) DC. stir-fried with bran, 90 parts of Phellodendron amurense Rupr. salted, 210 parts of Coix lacryma-jobi L. var. ma-yuen (Roman.) Stapf, 110 parts of Plantago asiatica L., 110 parts of Tetrapanax papyrifer (Hook.) K. Koch, 90 parts of Cyathula officinalis Kuan stir-fried with wine and 280 parts of Ramulus Mori stir-fried.

[0038] The preparation method of the above traditional Chinese medicine composition for treating rheumatoid arthritis comprises the following steps: The above eleven flavors are decocted with water three times. For the first time, 11 times the amount of water is added, and for the second and third times, 8 times the amount of water is added. Each decoction is for 1 hour. The decoction liquid is filtered, and the filtrates are combined. The filtrate is concentrated to a clear paste with a relative density of 1.20 (60 °C), an appropriate amount of dextrin is added, granulated, and mixed to make 1000 g, thus obtaining.

[0039] Example 6

[0040] A traditional Chinese medicine composition for treating rheumatoid arthritis is prepared from the following components in parts by weight: 100 parts of Heracleum hemsleyanum, 100 parts of Notopterygium incisum, 100 parts of Stephania tetrandra, 200 parts of Siegesbeckia orientalis L. var. pubescens Makino, 150 parts of Atractylodes lancea (Thunb.) DC. stir-fried with bran, 100 parts of Phellodendron amurense Rupr. salted, 200 parts of Coix lacryma-jobi L., 100 parts of Plantago asiatica L., 100 parts of Tetrapanax papyrifer (Hook.) K. Koch, 100 parts of Cyathula officinalis Kuan prepared with wine, and 300 parts of Ramulus Mori stir-fried.

[0041] The preparation method of the above traditional Chinese medicine composition for treating rheumatoid arthritis comprises the following steps: The above eleven herbs are decocted with water three times. For the first time, 11 times the amount of water is added, and for the second and third times, 8 times the amount of water is added. Each decoction is for 1 hour. The decoction liquid is filtered, and the filtrates are combined. The combined filtrate is concentrated to a clear paste with a relative density of 1.20 (60 °C), an appropriate amount of dextrin is added, granulated, and mixed to make 1000 g, thus obtaining the product.

[0042] Comparative Example 1

[0043] A traditional Chinese medicine composition for treating rheumatoid arthritis is prepared from the following components in parts by weight: 100 parts of Heracleum hemsleyanum, 100 parts of Notopterygium incisum, 100 parts of Gentiana macrophylla Pall., 200 parts of Piper kadsura (Choisy) Ohwi, 150 parts of Magnolia officinalis Rehd. et Wils., 100 parts of Phellodendron amurense Rupr. salted, 200 parts of Coix lacryma-jobi L., 100 parts of Plantago asiatica L., 100 parts of Tetrapanax papyrifer (Hook.) K. Koch, 100 parts of Cyathula officinalis Kuan prepared with wine, and 300 parts of Ramulus Mori stir-fried.

[0044] The preparation method of the above traditional Chinese medicine composition for treating rheumatoid arthritis comprises the following steps: The above eleven herbs are decocted with water three times. For the first time, 11 times the amount of water is added, and for the second and third times, 8 times the amount of water is added. Each decoction is for 1 hour. The decoction liquid is filtered, and the filtrates are combined. The combined filtrate is concentrated to a clear paste with a relative density of 1.20 (60 °C), an appropriate amount of dextrin is added, granulated, and mixed to make 1000 g, thus obtaining the product.

[0045] Comparative Example 2

[0046] A traditional Chinese medicine composition for treating rheumatoid arthritis is prepared from the following components in parts by weight: 100 parts of Heracleum hemsleyanum, 150 parts of Notopterygium incisum, 60 parts of Stephania tetrandra, 200 parts of Siegesbeckia orientalis L. var. pubescens Makino, 150 parts of Atractylodes lancea (Thunb.) DC. stir-fried with bran, 100 parts of Phellodendron amurense Rupr. salted, 100 parts of Coix lacryma-jobi L., 60 parts of Plantago asiatica L., 100 parts of Lysimachia christinae Hance, 100 parts of Cyathula officinalis Kuan prepared with wine, and 300 parts of Ramulus Mori stir-fried.

[0047] The preparation method of the above traditional Chinese medicine composition for treating rheumatoid arthritis comprises the following steps: The above eleven herbs are decocted with water three times. For the first time, 11 times the amount of water is added, and for the second and third times, 8 times the amount of water is added. Each decoction is for 1 hour. The decoction liquid is filtered, and the filtrates are combined. The combined filtrate is concentrated to a clear paste with a relative density of 1.20 (60 °C), an appropriate amount of dextrin is added, granulated, and mixed to make 1000 g, thus obtaining the product.

[0048] Test Example

[0049] 1. General information

[0050] Thirty male and thirty female patients with rheumatoid arthritis who came to the hospital for treatment were recruited, aged between 16 and 65 years old.

[0051] 2. Disease diagnosis criteria

[0052] (1) Traditional Chinese medicine (TCM) dialectical criteria: The TCM syndrome diagnosis criteria in the guiding principles for clinical research on new TCM drugs for the treatment of rheumatoid arthritis were adopted;

[0053] Blood stasis blocking collaterals syndrome:

[0054] Main symptoms: Joint swelling and stabbing pain, or pain being worse at night, limited joint flexion and extension, morning stiffness, joint deformity;

[0055] Secondary symptoms: Subcutaneous nodules, dull skin color at the local joint, dry and dull skin, or rough and scaly skin, scanty or absent menstruation in women;

[0056] Tongue and pulse: Purple and dark tongue with ecchymosis or petechiae, deep, thready and unsmooth pulse.

[0057] (2) Western medicine diagnosis criteria: The American College of Rheumatology (ACR) criteria;

[0058] 3. Inclusion criteria

[0059] (1) Meeting the western medicine diagnosis criteria and TCM dialectical criteria;

[0060] (2) Aged 16 - 65 years old;

[0061] (3) Voluntarily serving as a subject and accepting drug treatment.

[0062] 4. Exclusion criteria

[0063] (1) Pregnant or lactating women;

[0064] (2) Patients with active peptic ulcer, hematopoietic system diseases, and severe organic diseases of important organs such as the heart, liver, and kidneys, and psychiatric patients;

[0065] (3) Patients who have been using steroid drugs or other Chinese and western drugs for a long time and are not easy to stop taking the drugs;

[0066] (4) Patients who did not take the drugs as prescribed, making it impossible to judge the curative effect or having incomplete data, etc., affecting the judgment of the curative effect.

[0067] 5. Administration method

[0068] The confirmed patients were randomly divided into 3 groups, with 20 patients in each group. Each group of patients was given the drugs in Example 6 and Comparative Examples 1-2, three times a day, 10 g each time (equivalent to 1.55 g of decoction pieces), and taken continuously for 4 weeks to observe the treatment conditions of the patients.

[0069] 6. Observation indicators

[0070] (1) Main related symptoms

[0071] Joint pain, joint swelling, limited joint flexion and extension, morning stiffness and related manifestations;

[0072] (2) Main related signs

[0073] Number of joint tenderness, number of joint swelling (the number of joint pain and joint swelling are calculated for bilateral proximal interphalangeal, metacarpophalangeal, wrist, elbow, shoulder, and knee joints, a total of 28 joints), joint function, average grip strength of both hands (mmHg), pain, joint X-ray stage, morning stiffness.

[0074] (3) Physical and chemical examinations

[0075] Joint X-ray examination, rheumatoid factor (RF), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP).

[0076] 7. Efficacy evaluation criteria

[0077] Disease efficacy determination criteria:

[0078] (1) Marked effect: The overall improvement rate of main symptoms and signs is ≥75%, and the erythrocyte sedimentation rate and C-reactive protein are normal or significantly improved or nearly normal;

[0079] (2) Improvement: The overall improvement rate of main symptoms and signs is ≥50%, and the erythrocyte sedimentation rate and C-reactive protein are improved;

[0080] (3) Effectiveness: The overall improvement rate of main symptoms and signs is ≥30%, and the erythrocyte sedimentation rate and C-reactive protein are improved or not improved;

[0081] (4) Ineffectiveness: The overall improvement rate of main symptoms and signs is <30%, and the erythrocyte sedimentation rate and C-reactive protein are not improved;

[0082] The main symptoms and signs refer to the number of joint tenderness, the number of joint swelling, the morning stiffness time (minutes), the average grip strength of both hands (mmHg), and pain. The overall improvement rate refers to the improvement percentage of the above 5 indicators, that is, [(value before treatment - value after treatment) / value before treatment]*100

[0083] Syndrome efficacy determination criteria

[0084] (1) Clinical cure: The traditional Chinese medicine clinical symptoms and signs disappear or basically disappear, and the syndrome integral is reduced by ≥95%;

[0085] (2) Marked effect: The clinical symptoms and signs in traditional Chinese medicine are significantly improved, and the syndrome integral is reduced by ≥ 70%;

[0086] (3) Effective: The clinical symptoms and signs in traditional Chinese medicine are improved, and the syndrome integral is reduced by ≥ 30%;

[0087] (4) Ineffective: The clinical symptoms and signs in traditional Chinese medicine are not significantly improved, or even worsened, and the syndrome integral is reduced by less than 30%.

[0088] The calculation formula (Nimodipine method) is: [(Integral before treatment - Integral after treatment) / Integral before treatment] * 100%

[0089] 7. Therapeutic effect results

[0090] (1) Statistically calculate the improvement rates of the main signs after treatment to varying degrees. The percentages of the improvement rates refer to the criteria for judging the therapeutic effect of the disease, as shown in Table 1 specifically:

[0091] Table 1:

[0092]

[0093] (2) Record the erythrocyte sedimentation rate (ESR), rheumatoid factor (RF), and C-reactive protein (CRP) before and after treatment. The specific results are shown in Table 2.

[0094] Table 2:

[0095]

[0096] (3) Statistically calculate the number of cases with different degrees of reduction rates of the integral values of the traditional Chinese medicine syndromes after treatment. The specific results are shown in Table 3.

[0097] Table 3:

[0098]

[0099]

[0100] From the results in Tables 1 - 3, it can be known that the drug in Example 6 has a better therapeutic effect on rheumatoid arthritis. After 4 weeks of treatment, the symptoms and signs of the patients are significantly improved. After adjusting the prescription components in Comparative Example 1 and Comparative Example 2, compared with the group in Example 6, the therapeutic effect becomes worse, which proves that the various components in the traditional Chinese medicine composition of this application coordinate with each other and complement each other to achieve a better therapeutic effect.

[0101] Typical cases

[0102] Case 1: Zhao XX, female, 30 years old, came to the hospital for treatment in February 2020. She reported having joint pain and swelling in the limbs for more than two years. After seeking medical advice, she was diagnosed with rheumatoid arthritis and treated with methotrexate. However, the symptoms recurred after stopping the medication. The drug in Example 6 was prescribed for her. After taking it continuously for 4 weeks, the patient reported significant improvement in symptoms during the review. The symptoms of joint pain and swelling basically disappeared. She was continued to take the drug for another 2 weeks. During the review half a year later, there was no recurrence.

[0103] Case 2: Chen XX, female, 62 years old, came to the hospital for treatment in September 2021. She reported having joint pain and swelling in the limbs for more than five years. After seeking medical advice, she was confirmed to have rheumatoid arthritis and had taken multiple drugs such as leflunomide, methotrexate, and meloxicam for treatment. Although the symptoms were somewhat relieved after taking the drugs, the pain and swelling symptoms still persisted. The drug in Example 6 was prescribed for her. After taking it continuously for 6 weeks, during the review, the patient reported that the symptoms of joint pain and swelling had been significantly relieved and the range of flexion and extension had increased. She was continued to take the drug for another 4 weeks. During the review one year later, there was no recurrence.

[0104] Case 3: Liang XX, female, 56 years old, came to the hospital for treatment in September 2022. She reported having joint pain and swelling in multiple parts of the limbs for more than four years. After seeking medical advice, she was diagnosed with rheumatoid arthritis and had taken multiple drugs such as methotrexate and meloxicam for treatment. Although the symptoms were somewhat relieved after taking the drugs, they recurred after stopping the medication. The traditional Chinese medicine composition in Example 6 was prescribed for her. After taking it continuously for 5 weeks, during the review, the patient reported that the pain and swelling had been relieved and the range of joint flexion and extension had increased. She was continued to take the drug for another 4 weeks. During the review half a year later, there was no recurrence.

[0105] Case 4: Liu XX, male, 53 years old, came to the hospital for treatment in February 2023. He reported having joint pain and swelling in the limbs for more than three years. After seeking medical advice, he was confirmed to have rheumatoid arthritis and had taken drugs such as sulfasalazine, hydroxychloroquine, and methotrexate many times, but the symptoms recurred after stopping the medication and were not completely relieved. The drug in Example 6 was prescribed for him. When he came for a follow-up visit after taking it continuously for 5 weeks, he reported that the pain and swelling symptoms had been significantly relieved. He was continued to take the drug for another 4 weeks. During the follow-up visit half a year later, there was no recurrence.

Claims

1. A traditional Chinese medicine composition for treating rheumatoid arthritis, characterized in that, It comprises the following components in parts by weight: 70 - 130 parts of Heracleum hemsleyanum, 70 - 130 parts of Notopterygium incisum, 70 - 130 parts of Stephania tetrandra, 170 - 230 parts of Siegesbeckia orientalis, 130 - 170 parts of Atractylodes lancea, 70 - 130 parts of Phellodendron amurense, 170 - 230 parts of Coix lacryma-jobi, 70 - 130 parts of Plantago asiatica, 70 - 130 parts of Tetrapanax papyriferus, 70 - 130 parts of Achyranthes bidentata, and 260 - 340 parts of Ramulus Mori.

2. The traditional Chinese medicine composition for treating rheumatoid arthritis according to claim 1, wherein, It comprises the following components in parts by weight: 90 - 110 parts of Heracleum hemsleyanum, 90 - 110 parts of Notopterygium incisum, 90 - 110 parts of Stephania tetrandra, 180 - 210 parts of Siegesbeckia orientalis, 140 - 160 parts of Atractylodes lancea, 90 - 110 parts of Phellodendron amurense, 180 - 210 parts of Coix lacryma-jobi, 90 - 110 parts of Plantago asiatica, 90 - 110 parts of Tetrapanax papyriferus, 90 - 110 parts of Achyranthes bidentata, and 280 - 310 parts of Ramulus Mori.

3. The traditional Chinese medicine composition for treating rheumatoid arthritis according to claim 1 or 2, wherein, It comprises the following components in parts by weight: 90 parts of Heracleum hemsleyanum, 110 parts of Notopterygium incisum, 110 parts of Stephania tetrandra, 210 parts of Siegesbeckia orientalis, 160 parts of Atractylodes lancea, 110 parts of Phellodendron amurense, 180 parts of Coix lacryma-jobi, 90 parts of Plantago asiatica, 90 parts of Tetrapanax papyriferus, 110 parts of Achyranthes bidentata, and 310 parts of Ramulus Mori.

4. The traditional Chinese medicine composition for treating rheumatoid arthritis according to claim 1 or 2, characterized in that, It comprises the following components in parts by weight: 110 parts of Heracleum hemsleyanum, 90 parts of Notopterygium incisum, 90 parts of Stephania tetrandra, 180 parts of Siegesbeckia orientalis, 140 parts of Atractylodes lancea, 90 parts of Phellodendron amurense, 210 parts of Coix lacryma-jobi, 110 parts of Plantago asiatica, 110 parts of Tetrapanax papyriferus, 90 parts of Achyranthes bidentata, and 280 parts of Ramulus Mori.

5. The traditional Chinese medicine composition for treating rheumatoid arthritis according to claim 1 or 2, characterized in that It comprises the following components in parts by weight: 100 parts of Heracleum hemsleyanum, 100 parts of Notopterygium incisum, 100 parts of Stephania tetrandra, 200 parts of Siegesbeckia orientalis, 150 parts of Atractylodes lancea, 100 parts of Phellodendron amurense, 200 parts of Coix lacryma-jobi, 100 parts of Plantago asiatica, 100 parts of Tetrapanax papyriferus, 100 parts of Achyranthes bidentata, and 300 parts of Ramulus Mori.

6. The traditional Chinese medicine composition for treating rheumatoid arthritis according to claim 1, wherein, The Siegesbeckia orientalis is Siegesbeckia orientalis processed with wine, the Atractylodes lancea is Atractylodes lancea stir-fried with bran, the Phellodendron amurense is Phellodendron amurense processed with salt, the Achyranthes bidentata is Cyathula officinalis processed with wine, and the Ramulus Mori is Ramulus Mori stir-fried.

7. A method for preparing the traditional Chinese medicine composition for treating rheumatoid arthritis according to any one of claims 1-6, characterized in that, It is prepared by pulverizing and mixing each raw material drug; or by preparing the extracts obtained by mixing or separately extracting each raw material drug; or by preparing the active ingredients obtained by further refining and purifying the extracts; or by adding pharmaceutically acceptable excipients to the extracts / active ingredients.

8. The preparation method of the traditional Chinese medicine composition for treating rheumatoid arthritis according to claim 7, characterized in that, The dosage form prepared is one of pills, granules, capsules, powders, mixtures or oral liquids.

9. The preparation method of the traditional Chinese medicine composition for treating rheumatoid arthritis according to claim 1, characterized in that, The specific preparation method is as follows: For the above nine herbs, add water for decoction, filter the decoction liquid, combine the filtrates, concentrate under reduced pressure to a clear paste with a relative density of 1.15 - 1.25, and granulate with pharmaceutically acceptable excipients to obtain the product.

10. Use of the traditional Chinese medicine composition according to any one of claims 1 - 6 in the preparation of a drug for treating rheumatoid arthritis.

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