A Chinese medicine composition, preparation and application for treating rheumatoid arthritis of cold-dampness and arthralgia type

Abstract

The present invention relates to the field of traditional Chinese medicine, and specifically provides a traditional Chinese medicine composition for treating rheumatoid arthritis of cold-dampness and arthralgia type, characterized in that the traditional Chinese medicine composition comprises the following components: the traditional Chinese medicine composition comprises the following components: radix kauri (made with wine), bark of pittosporum tobira, radix clematis, angelica, rhizoma chuanxiong, cibotium barometz, chuanduan, rhizoma cynomorii, eucommia barometz, papaya, atractylodes, radix pubescens, herba viticolae, cassia twig, asarum, scorpion, herba scrofa, frankincense, myrrh, chuanxiong, nectarine, radix scutellariae, and licorice. The traditional Chinese medicine composition of the present invention has the effects of dispelling wind and cold, nourishing liver and kidney, relaxing muscles and activating blood circulation, and dredge meridians to relieve pain, and can be used for diseases such as numbness, waist and leg pain, and rheumatic joint pain. Because of its outstanding efficacy, it is widely welcomed by clinical patients.

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, preparation and application for treating rheumatoid arthritis of cold-dampness and numbness type. Background Art

[0002] Rheumatoid arthritis (RA) is a chronic, systemic autoimmune disease characterized by synovial inflammation, which often leads to joint pain, swelling, stiffness and dysfunction. Among them, cold-dampness-blocking RA is a classification of the disease in traditional Chinese medicine, which is mainly manifested by joint pain, swelling, poor flexion and extension, aggravated by cold, relieved by heat, obvious morning stiffness, white and greasy tongue coating, and slow pulse. Western medicine mainly uses non-steroidal anti-inflammatory drugs, immunosuppressants and other drugs to treat this disease, but long-term use is prone to drug resistance, adverse reactions and other problems. Therefore, it is of great clinical significance to explore safe and effective traditional Chinese medicine treatment methods.

[0003] The unique advantages of traditional Chinese medicine in the treatment of rheumatic diseases are increasingly valued. However, there is still a lack of systematic research on its specific efficacy in the treatment of cold-dampness-blocking rheumatoid arthritis (RA) and its effects on joint pain and function in patients. In view of this, this study aims to explore the efficacy of traditional Chinese medicine prescriptions in the treatment of cold-dampness-blocking RA through clinical trials, and evaluate its effects on joint pain and function in patients, in order to provide new ideas and methods for the traditional Chinese medicine treatment of RA. Summary of the invention

[0004] The present invention aims to provide a Chinese medicine composition, preparation and application for treating rheumatoid arthritis of cold-dampness and arthralgia type. The Chinese medicine composition comprises the following components: Pittosporum glabra (made with wine), Pittosporum tobira bark, Clematis chinensis, Angelica sinensis, Rhizoma Chuanxiong, Cibotium barometz, Rhizoma Chuanduan, Rhizoma Cynoglossi, Eucommia barometz, Chaenomeles sinensis, Atractylodes lancea, Angelica dahurica, Viscum album, Saposhnikovia divaricata, Cinnamomum cassia, Asarum sieboldii, Scorpio, Herba Polygoni Multiflori, Olibanum officinale, Myrrh, Sichuan pepper, Nymphaeaceae, Rhizoma Atractylodis Macrocephalae, and Licorice.

[0005] As an embodiment of the present invention, the Chinese medicine composition includes the following components in parts by weight: 25-40 parts of Pittosporum tobira (made with wine), 10-15 parts of Pittosporum tobira bark, 20-40 parts of Clematis, 5-12 parts of Angelica sinensis, 8-15 parts of Ligusticum chuanxiong, 25-35 parts of Cibotium bark, 25-35 parts of Chuanduan, 25-35 parts of Cyathula officinalis, 10-20 parts of Eucommia ulmoides, 20-35 parts of Papaya, 10-20 parts of Atractylodes macrocephala, 25-40 parts of Angelica dahurica, 12-20 parts of Viscum album, 15-25 parts of Saposhnikovia divaricata, 8-15 parts of Cassia twig, 2-5 parts of Asarum, 2-5 parts of Scorpio, 5-8 parts of Radix Penicillae Sinensis, 5-8 parts of Frankincense, 5-8 parts of Myrrh, 8-10 parts of Sichuan pepper, 5-8 parts of Beehives, 2-5 parts of Achyranthes bidentata, and 2-5 parts of Licorice.

[0006] As an embodiment of the present invention, the Chinese medicine composition includes the following components in parts by weight: 30 parts of Pittosporum tobira (made with wine), 12 parts of Pittosporum tobira bark, 30 parts of Clematis, 10 parts of Angelica sinensis, 10 parts of Ligusticum chuanxiong, 30 parts of Cibotium bark, 30 parts of Chuanduan, 30 parts of Cyathula officinalis, 15 parts of Eucommia ulmoides, 30 parts of Papaya, 15 parts of Atractylodes macrocephala, 30 parts of Angelica dahurica, 15 parts of Viscum album, 20 parts of Saposhnikovia divaricata, 10 parts of Cassia twig, 3 parts of Asarum, 3 parts of Scorpio, 6 parts of Radix Polygoni Multiflori, 6 parts of Frankincense, 6 parts of Myrrh, 9 parts of Sichuan pepper, 6 parts of Beehives, 3 parts of Achyranthes bidentata, and 3 parts of Licorice.

[0007] The second aspect of the present invention provides a pharmaceutical preparation, which comprises the traditional Chinese medicine composition and / or pharmaceutically acceptable excipients.

[0008] As an embodiment of the present invention, the dosage form of the pharmaceutical preparation is selected from tablets, granules, capsules, powders or solutions.

[0009] The third aspect of the present invention provides a method for preparing the pharmaceutical preparation, the steps of the preparation method are as follows:

[0010] S01 classifies the components of the traditional Chinese medicine composition;

[0011] S02 extracts components from the Chinese medicine composition classified in step S01;

[0012] S03 prepares a pharmaceutical preparation from the components extracted in step S02.

[0013] As an implementation of the present invention, in step S01, the classification is as follows:

[0014] Group A: Pitfalls chinensis (made from wine), Pittosporum tobira bark, and Clematis chinensis;

[0015] These three herbs all have the effects of dispelling wind and dampness, unblocking meridians and relieving pain, and are used to treat rheumatic pain.

[0016] Group B: Chinese Angelica, Chuanxiong, Cibotium barometz, Rhizoma Cynomorii, Rhizoma Cynomorii, Eucommia barometz, and Papaya;

[0017] This group of herbs is mainly used to promote blood circulation and remove blood stasis, strengthen tendons and bones, and has a good effect on treating blood stasis, weak tendons and bones in arthritis.

[0018] Group C: Atractylodes lancea, Angelica dahurica, Morus alba, Saposhnikovia divaricata, Cinnamomum cassia twig, Asarum sieboldii;

[0019] This group of herbs mainly dispels wind and cold, removes dampness and relieves pain, and is suitable for pain caused by wind, cold and dampness.

[0020] Group D: Scorpio, Radix Poriae Cibotii, frankincense, myrrh, Sichuan pepper, beehive, dragonfly, and liquorice;

[0021] This group of medicinal materials has the effects of dredging meridians and relieving pain, promoting blood circulation and removing blood stasis, detoxifying and reducing swelling. It has a good therapeutic effect on the pain, swelling and other symptoms of arthritis.

[0022] As an embodiment of the present invention, the specific steps of step S02 are as follows: the effective components of groups A to D are extracted separately, and then mixed and concentrated.

[0023] The fourth aspect of the present invention provides the use of the traditional Chinese medicine composition in the preparation of a drug for treating rheumatoid arthritis of the cold-dampness and arthralgia type.

[0024] As an implementation mode of the present invention, the specific mode of the application is as follows:

[0025] The Chinese medicine composition is administered together with Tripterygium wilfordii polyglycoside tablets (commercially available) and methotrexate tablets (commercially available). The specific dosage, administration cycle and administration method are as follows:

[0026] Tripterygium wilfordii polyglycoside tablets (specification 10 mg): 3 times a day, 1 tablet each time, orally;

[0027] Methotrexate tablets (specification 2.5 mg): once a week, 4 tablets each time, orally;

[0028] Chinese medicine composition: Specification: Each gram of granules contains 0.86g of raw medicine, twice a day, 15g each time, orally;

[0029] The above medication is used for 1 course of treatment, with 4 weeks as one course of treatment, for a total of 3 courses.

[0030] By adopting the above technical solution, the present invention has the following beneficial effects:

[0031] The Chinese medicine composition of the present invention uses Herba Piperis davidianae as the main medicine for dispelling wind and cold, relaxing muscles and activating blood circulation, and is matched with Cibotium barometz, Rhizoma Chuanxiong, Rhizoma Cynoglossi, Eucommia barometz, Radix Angelicae Pubescentis, Herba Mori Parasiticae and the like to nourish the liver and kidney, dispel wind and dredge collaterals as the minister, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Fructus Chaenomelis, Radix Clematis, Ramulus Cinnamomi, Olibanum, Myrrha for nourishing blood and activating blood circulation, relaxing muscles and dredge collaterals, Cortex Pittosporum, Folium Saposhnikoviae, Herba Polygoni Multiflori, Asarum, Fructus Chuanxiong, Folium Apium, Scorpio, and Rhizoma Cibotii for dispelling wind, dispelling cold, dredge collaterals and relieving pain as the assistant, Rhizoma Atractylodis Macrocephalae for drying dampness and invigorating spleen, protecting spleen and stomach as the assistant, and Radix Glycyrrhizae for harmonizing various medicines as the guiding medicine. The whole prescription plays the effects of dispelling wind and cold, nourishing the liver and kidney, relaxing muscles and activating blood circulation, dredge collaterals and relieving pain, and can be used for diseases such as numbness, pain in waist and legs, and rheumatic joint pain. Because of its remarkable curative effect, it is widely welcomed by clinical patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings in the following description are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0033] Figure 1 Comparison of TCM symptom scores between the control group and the study group;

[0034] Figure 2 The disease activity scores of 28 joints were compared between the control group and the study group;

[0035] Figure 3 Oswestry Disability Index (ODI) for the control group and the study group. DETAILED DESCRIPTION

[0036] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0037] The object of the present invention is to provide a Chinese medicine composition, preparation, application and preparation method for treating rheumatoid arthritis of cold-dampness and arthralgia type. The Chinese medicine composition comprises the following components: ephedra, aconite, tuckahoe, atractylodes, cassia twig, liquorice, dodder seed, leech, earthworm, mole cricket, nine-scented insect, silkworm cocoon, Pseudostellaria heterophylla and astragalus.

[0038] As an embodiment of the present invention, the Chinese medicine composition includes the following components in parts by weight: 25-40 parts of Pittosporum tobira (made with wine), 10-15 parts of Pittosporum tobira bark, 20-40 parts of Clematis, 5-12 parts of Angelica sinensis, 8-15 parts of Ligusticum chuanxiong, 25-35 parts of Cibotium bark, 25-35 parts of Chuanduan, 25-35 parts of Cyathula officinalis, 10-20 parts of Eucommia ulmoides, 20-35 parts of Papaya, 10-20 parts of Atractylodes macrocephala, 25-40 parts of Angelica dahurica, 12-20 parts of Viscum album, 15-25 parts of Saposhnikovia divaricata, 8-15 parts of Cassia twig, 2-5 parts of Asarum, 2-5 parts of Scorpio, 5-8 parts of Radix Penicillae Sinensis, 5-8 parts of Frankincense, 5-8 parts of Myrrh, 8-10 parts of Sichuan pepper, 5-8 parts of Beehives, 2-5 parts of Achyranthes bidentata, and 2-5 parts of Licorice.

[0039] As an embodiment of the present invention, the Chinese medicine composition includes the following components in parts by weight: 30 parts of Pittosporum tobira (made with wine), 12 parts of Pittosporum tobira bark, 30 parts of Clematis, 10 parts of Angelica sinensis, 10 parts of Ligusticum chuanxiong, 30 parts of Cibotium bark, 30 parts of Chuanduan, 30 parts of Cyathula officinalis, 15 parts of Eucommia ulmoides, 30 parts of Papaya, 15 parts of Atractylodes macrocephala, 30 parts of Angelica dahurica, 15 parts of Viscum album, 20 parts of Saposhnikovia divaricata, 10 parts of Cassia twig, 3 parts of Asarum, 3 parts of Scorpio, 6 parts of Radix Polygoni Multiflori, 6 parts of Frankincense, 6 parts of Myrrh, 9 parts of Sichuan pepper, 6 parts of Beehives, 3 parts of Achyranthes bidentata, and 3 parts of Licorice.

[0040] The invention uses Caulis Piperis davidiana as the main drug for dispelling wind and cold, relaxing muscles and activating blood circulation, and is combined with Cibotium barometz, Rhizoma Cynanchum, Eucommia barometz, Angelica pubescens, and Herba Mori as the ministers for tonifying liver and kidney, dispelling wind and unblocking collaterals, and Angelica sinensis, Rhizoma Chuanxiong, Chaenomeles papaya, Radix Clematis, Cinnamomum cassiae, Olibanum, and Myrrha for nourishing blood and activating blood circulation, relaxing muscles and activating collaterals, and Pittosporum tobira, Saposhnikovia divaricata, Herba Polygoni Multiflori, Asarum, Sichuan pepper, Beehive, Scorpio, and Rhizoma Cibotii as the assistants for dispelling wind and cold, unblocking collaterals, and relieving pain, and Atractylodes macrocephala is the assistant for drying dampness and invigorating spleen, protecting spleen and stomach, and Licorice is the guiding drug for harmonizing various drugs. The whole prescription plays the effects of dispelling wind and cold, tonifying liver and kidney, relaxing muscles and activating blood circulation, and unblocking collaterals and relieving pain, and can be used for diseases such as numbness, waist and leg pain, and rheumatic joint pain.

[0041] The second aspect of the present invention provides a pharmaceutical preparation, which comprises the traditional Chinese medicine composition and / or pharmaceutically acceptable excipients.

[0042] As an embodiment of the present invention, the dosage form of the pharmaceutical preparation is selected from tablets, granules, capsules, powders or solutions.

[0043] The composition of the present invention can be administered in a variety of ways, such as oral tablets, capsules, powders, oral liquids, injections and transdermal preparations. According to conventional pharmaceutical practice, pharmaceutically acceptable carriers include diluents, fillers, disintegrants, wetting agents, lubricants, colorants, flavoring agents or other conventional additives. Typical pharmaceutically acceptable carriers include, for example, microcrystalline cellulose, starch, crosslinked polyvinylpyrrolidone, povidone, polyvinylpyrrolidone, maltitol, citric acid, sodium lauryl sulfate or magnesium stearate.

[0044] The third aspect of the present invention provides a method for preparing the pharmaceutical preparation, the steps of the preparation method are as follows:

[0045] S01 classifies the components of the traditional Chinese medicine composition;

[0046] S02 decocts and extracts the components of the Chinese medicine composition classified in step S01;

[0047] S03 prepares a pharmaceutical preparation from the components extracted in step S02.

[0048] As an implementation of the present invention, in step S01, the classification is as follows:

[0049] Group A: Pitfalls chinensis (made from wine), Pittosporum tobira bark, and Clematis chinensis;

[0050] These three herbs all have the effects of dispelling wind and dampness, unblocking meridians and relieving pain, and are used to treat rheumatic pain.

[0051] Group B: Chinese Angelica, Chuanxiong, Cibotium barometz, Rhizoma Cynomorii, Rhizoma Cynomorii, Eucommia barometz, and Papaya;

[0052] This group of herbs is mainly used to promote blood circulation and remove blood stasis, strengthen tendons and bones, and has a good effect on treating blood stasis, weak tendons and bones in arthritis.

[0053] Group C: Atractylodes lancea, Angelica dahurica, Morus alba, Saposhnikovia divaricata, Cinnamomum cassia twig, Asarum sieboldii;

[0054] This group of herbs mainly dispels wind and cold, removes dampness and relieves pain, and is suitable for pain caused by wind, cold and dampness.

[0055] Group D: Scorpio, Radix Poriae Cibotii, frankincense, myrrh, Sichuan pepper, beehive, dragonfly, and liquorice;

[0056] This group of medicinal materials has the effects of dredging meridians and relieving pain, promoting blood circulation and removing blood stasis, detoxifying and reducing swelling. It has a good therapeutic effect on the pain, swelling and other symptoms of arthritis.

[0057] As an embodiment of the present invention, the specific steps of step S02 are as follows: the effective components of groups A to D are extracted separately, and then mixed and concentrated.

[0058] As an embodiment of the present invention, the preparation method of the pharmaceutical preparation specifically comprises the following steps:

[0059] (1) Soak the components of group A in water for 2 hours, then decoct them three times, adding 8 times the amount of water for the first time, and 6 times the amount of water for the second and third times, each time for 1 hour, filter, and combine the filtrate to obtain liquid A;

[0060] Soak the components of group B in water for 2 hours, then decoct for 3 times, add 10 times the amount of water for the first time, and add 8 times the amount of water for the second and third times, each time for 1 hour, filter, and combine the filtrate to obtain liquid B;

[0061] Soak the components of group C in water for 2 hours, then decoct for 3 times, add 12 times the amount of water for the first time, and add 10 times the amount of water for the second and third times, each time for 1 hour, filter, and combine the filtrate to obtain liquid C;

[0062] Soak the components of group D in water for 2 hours, then decoct them for 3 times, add 15 times the amount of water for the first time, and add 12 times the amount of water for the second and third times, each time for 1 hour, filter, and combine the filtrate to obtain liquid D;

[0063] (2) Mix the above-prepared drug solutions AD, and then concentrate to a clear paste with a relative density of 1.32-1.38, then add the extract of component B, stir and mix, and then concentrate to a clear paste with a relative density of 1.32-1.38; dry under reduced pressure, crush, and sieve;

[0064] (3) Add appropriate amount of auxiliary materials (such as dextrin, starch, etc.) and flavoring agents (such as stevioside, sucrose, etc.), mix well, granulate, and dry. The prepared granules contain 0.86 g of crude drug per gram of granules.

[0065] The fourth aspect of the present invention provides the use of the traditional Chinese medicine composition in the preparation of a drug for treating rheumatoid arthritis of the cold-dampness and arthralgia type.

[0066] As an implementation mode of the present invention, the specific mode of the application is as follows:

[0067] The Chinese medicine composition is administered together with Tripterygium wilfordii polyglycoside tablets (commercially available) and methotrexate tablets (commercially available). The specific dosage, administration cycle and administration method are as follows:

[0068] Tripterygium wilfordii polyglycoside tablets (specification 10 mg): 3 times a day, 1 tablet each time, orally;

[0069] Methotrexate tablets (specification 2.5 mg): once a week, 4 tablets each time, orally;

[0070] Chinese medicine composition: Specification: Each gram of granules contains 0.86g of raw medicine, twice a day, 15g each time, orally;

[0071] The above medication is used for 1 course of treatment, with 4 weeks as one course of treatment, for a total of 3 courses.

[0072] The Chinese medicine composition involved in the present invention fully reflects the in-depth understanding and unique treatment methods of traditional Chinese medicine for rheumatoid arthritis. This Chinese medicine formula follows the principle of syndrome differentiation and treatment of traditional Chinese medicine, and adopts multiple treatment methods such as dispelling wind and cold, removing dampness and unblocking meridians, promoting blood circulation and relieving pain for rheumatoid arthritis of cold-dampness and arthralgia type. The drugs such as Caulis Pittosporum, Pittosporum affine, and Radix Clematis in the prescription can dispel wind and dampness, dispel cold and unblock meridians, and have significant therapeutic effects on the cold-dampness and arthralgia symptoms of rheumatoid arthritis. Blood circulation and stasis-removing drugs such as Angelica sinensis and Rhizoma Chuanxiong can improve blood circulation and relieve pain; drugs such as Cibotium barometz, Rhizoma Chuanxiong, Rhizoma Cynoglossi, and Eucommia barometz have the effect of strengthening tendons and bones, can enhance the stability of joints, and reduce joint damage; in addition, drugs such as papaya, Atractylodes lancea, and Radix Angelicae Pubescentis can dispel wind and dampness, and improve the symptoms of heavy dampness in joints. Drugs such as Viscum album, Saposhnikovia divaricata, and Cinnamomum cassia can enhance the body's resistance and prevent the recurrence of the disease. Drugs such as Asarum, Scorpion, and Herba Scutellariae have the effects of warming the meridians and dispelling cold, dredge the collaterals and relieve pain, and can significantly improve the pain and stiffness symptoms of joints; finally, drugs such as frankincense, myrrh, and Sichuan pepper can promote blood circulation and remove blood stasis, reduce swelling and relieve pain, and have obvious relief effects on the swelling and pain of rheumatoid arthritis. Drugs such as Nasturtium and Rhizoma Dioscoreae have the effects of dispelling wind and dampness, dredge the meridians and activate the collaterals, and can further improve the symptoms of joints. Licorice can reconcile various drugs and enhance the overall efficacy of the prescription. In general, the prescription for the treatment of rheumatoid arthritis (cold-dampness arthralgia type) of the present invention embodies the unique concept and rich experience of traditional Chinese medicine for the treatment of rheumatoid arthritis, and has a positive effect on improving patient symptoms and improving the quality of life. The present invention, according to the characteristics of the components, gives play to the advantages of each component and avoids the disadvantages, and plays the maximum drug effect.

[0073] The present invention is further explained below in conjunction with specific implementation modes.

[0074] Example 1

[0075] The present embodiment provides a traditional Chinese medicine preparation, which consists of the following components: 30g of Pittosporum tobira (made with wine), 12g of Pittosporum tobira bark, 30g of Clematis, 10g of Angelica sinensis, 10g of Ligusticum chuanxiong, 30g of Cibotium bark, 30g of Chuanduan, 30g of Cyathula officinalis, 15g of Eucommia ulmoides, 30g of Papaya, 15g of Atractylodes macrocephala, 30g of Angelica dahurica, 15g of Viscum album, 20g of Saposhnikovia divaricata, 10g of Cassia twig, 3g of Asarum, 3g of Scorpio, 6g of Radix Pennisetum, 6g of Frankincense, 6g of Myrrh, 9g of Sichuan pepper, 6g of Niva vomica, 3g of Achyranthes bidentata, and 3g of Licorice.

[0076] And the groups are as follows:

[0077] Group A: Pitfalls chinensis (made from wine), Pittosporum tobira bark, and Clematis chinensis;

[0078] Group B: Chinese Angelica, Chuanxiong, Cibotium barometz, Rhizoma Cynomorii, Rhizoma Cynomorii, Eucommia barometz, and Papaya;

[0079] Group C: Atractylodes lancea, Angelica dahurica, Morus alba, Saposhnikovia divaricata, Cinnamomum cassia twig, Asarum sieboldii;

[0080] Group D: Scorpio, Radix Poriae Cibotii, frankincense, myrrh, Sichuan pepper, beehive, dragonfly, and liquorice;

[0081] The preparation method is as follows:

[0082] (1) Soak the components of group A in water for 2 hours, then decoct them three times, adding 8 times the amount of water for the first time, and 6 times the amount of water for the second and third times, each time for 1 hour, filter, and combine the filtrate to obtain liquid A;

[0083] Soak the components of group B in water for 2 hours, then decoct for 3 times, add 10 times the amount of water for the first time, and add 8 times the amount of water for the second and third times, each time for 1 hour, filter, and combine the filtrate to obtain liquid B;

[0084] Soak the components of group C in water for 2 hours, then decoct for 3 times, add 12 times the amount of water for the first time, and add 10 times the amount of water for the second and third times, each time for 1 hour, filter, and combine the filtrate to obtain liquid C;

[0085] Soak the components of group D in water for 2 hours, then decoct them for 3 times, add 15 times the amount of water for the first time, and add 12 times the amount of water for the second and third times, each time for 1 hour, filter, and combine the filtrate to obtain liquid D;

[0086] (2) Mix the above-prepared drug solutions AD, and then concentrate to a clear paste with a relative density of 1.32-1.38, then add the extract of component B, stir and mix, and then concentrate to a clear paste with a relative density of 1.32-1.38; dry under reduced pressure, crush, and sieve;

[0087] (3) Add auxiliary materials (such as dextrin, starch, etc.) and flavoring agents (such as stevioside, sucrose, etc.), mix well, granulate, and dry. The prepared granules contain 0.86 g of crude drug per gram of granules.

[0088] Example 2

[0089] The present embodiment provides a traditional Chinese medicine preparation, which consists of the following components: 25g of Pittosporum tobira (made with wine), 15g of Pittosporum tobira bark, 15g of Clematis, 15g of Angelica sinensis, 15g of Ligusticum chuanxiong, 25g of Cibotium bark, 25g of Chuanduan, 25g of Cyathula officinalis, 12g of Eucommia ulmoides, 25g of Papaya, 12g of Atractylodes macrocephala, 25g of Angelica dahurica, 12g of Viscum album, 18g of Saposhnikovia divaricata, 15g of Cassia twig, 2g of Asarum, 6g of Scorpio, 9g of Radix Pennisetum, 9g of Frankincense, 9g of Myrrh, 6g of Sichuan pepper, 9g of Nivium canna, 6g of Achyranthes bidentata, and 6g of Licorice.

[0090] The grouping of drug components and the preparation method of the Chinese medicine preparation are the same as those in Example 1.

[0091] Example 3

[0092] The present embodiment provides a traditional Chinese medicine preparation, which consists of the following components: 20g of Pittosporum tobira (made with wine), 18g of Pittosporum tobira bark, 35g of Clematis, 12g of Angelica sinensis, 12g of Ligusticum chuanxiong, 20g of Cibotium barometz, 20g of Chuanduan, 20g of Cyathula officinalis, 18g of Eucommia ulmoides, 35g of Papaya, 18g of Atractylodes macrocephala, 35g of Angelica dahurica, 18g of Viscum album, 22g of Saposhnikovia divaricata, 12g of Cassia twig, 6g of Asarum, 9g of Scorpio, 12g of Radix Pennisetum, 12g of Frankincense, 12g of Myrrh, 12g of Sichuan pepper, 12g of Niva pumila, 9g of Achyranthes bidentata, and 9g of Licorice.

[0093] The grouping of drug components and the preparation method of the Chinese medicine preparation are the same as those in Example 1.

[0094] Application Examples

[0095] The clinical efficacy of the Chinese medicine composition disclosed in the present invention was tracked, and the treatment process and results are as follows:

[0096] 1. Clinical treatment methods

[0097] 1.1 Patient Information

[0098] From December 2022 to March 2024, 90 patients with cold-dampness obstruction type RA were selected. Inclusion criteria: ① Meet the diagnostic criteria for RA, and TCM syndrome differentiation is cold-dampness obstruction syndrome; ② Aged between 18 and 75 years old (male and female); ③ All signed informed consent in the hospital. Exclusion criteria: ① pregnant women, women preparing for pregnancy or breastfeeding; ② severe system involvement, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, atrophic gastritis, autoimmune liver disease, etc.; ③ active liver disease or abnormal liver function, ALT, AST is more than 1.2 times the upper limit of normal value; ④ renal function damage, serum creatinine is more than 1.6 times the upper limit of normal value; ⑤ peripheral blood leukocytes <3.5×109 / L, hemoglobin <90g / L, platelets <100×109 / L, or other blood system diseases; ⑥ previous adverse reactions to methotrexate; ⑦ patients who used hormones 2 weeks before enrollment and are participating in other clinical trials. The grouping method was random number table method, divided into control group (45 cases, conventional western medicine treatment) and study group (45 cases, conventional western medicine + treatment of the present invention), the baseline patient information of the two groups was compared, and there was no statistical significance (P>0.05), see Table 1.

[0099] Table 1 Comparison of baseline patient information between the two groups ( n, %)

[0100]

[0101] 1.2 Methods

[0102] The control group was treated with Tripterygium wilfordii polyglycoside tablets (National Medicine Standard Z42021534, specification 10 mg), 3 times a day, 1 tablet each time, orally; methotrexate tablets (National Medicine Standard H31020644, specification 2.5 mg), 4 tablets each time, once a week, orally. The treatment course was 4 weeks, and there were 3 courses in total.

[0103] The research group combined the Chinese medicine composition of the present invention for treatment on the basis of the control group, with 30g of Pittosporum tobira bark, 12g of Clematis chinensis, 10g of Angelica sinensis, 10g of Chuanxiong, 30g of Cibotium barometz, 30g of Chuanduan, 30g of Cyathula officinalis, 15g of Eucommia bark, 30g of Chaenomeles sinensis, 15g of Atractylodes macrocephala, 30g of Angelica dahurica, 15g of Eucommia bark, 15g of Atractylodes macrocephala, 30g of Angelica dahurica, 15g of Viscum album, 20g of Saposhnikovia divaricata, 10g of Cinnamomum cassia, 3g of Asarum, 3g of Scorpio, 6g of Radix Angelicae Sinensis, 6g of Olibanum, 6g of Myrrh, 9g of Sichuan pepper, 6g of Niva, 3g of Achyranthes bidentata, and 3g of Licorice. Granules were prepared by the preparation method of Example 1, stored in a sealed light-shielding manner, and taken with warm water, once a day after breakfast and dinner, 15g each time, 4 weeks as a course of treatment, and 3 courses of treatment were continuously treated. The method, dosage, and course of treatment of Tripterygium wilfordii polyglycoside tablets and methotrexate tablets taken by the research group were referred to the control group scheme.

[0104] 1.3 Observation indicators

[0105] ① ACR20 effectiveness: The efficacy is determined according to the ACR20 standard: the number of joint swelling and tenderness is reduced by ≥20%, and at least 3 of the five indicators, including pain VAS score, overall disease condition VAS score (assessed by subjects and researchers), Health Status Questionnaire (HAQ), CRP or ESR, are improved by ≥20%.

[0106] ② TCM symptom score: The main symptoms of joint swelling, pain, tenderness, morning stiffness, and difficulty in flexion and extension are scored as 0, 2, 4, and 6 points according to none, mild, moderate, and severe; secondary symptoms such as thirst, joint soreness, fatigue, and fear of wind and cold are scored as 0, 1, 2, and 3 points. The total score of TCM symptom score is calculated to evaluate the condition.

[0107] ③Inflammatory factors: 5 mL of fasting venous blood was collected from the patient, and the serum was separated after centrifugation. The serum CRP, TNF-α, and IL-6 levels were detected by ELISA.

[0108] ④Joint function: The RA pain, joint dysfunction and daily self-care ability of the two groups of patients were evaluated according to the Disease Activity Score 28 (DAS28) of 28 joints, the Oswestry Disability Index (ODI) and the Health Assessment Questionnaire (HAQ). The higher the score, the worse the improvement effect. DAS-28 classification: high activity AS28>5.1, medium activity 3.2<DAS28≤5.1, low activity 3.2≥DAS28>2.6, disease improvement: DAS28≤2.6. HAQ score: contains 20 questions, involving 8 functions, with a four-level score of 0-3, 0 for no problem and 3 for incompetence. VAS score: The subjects and researchers scored the overall condition of the disease from 0 to 10 cm to evaluate the disease control status and activity status, and the score was accurate to 1 decimal place.

[0109] 1.4 Statistical methods

[0110] SPSS22.0 was used to analyze the ACR20 efficacy and DAS28, ODI, HAQ scores and other data. The enumeration data such as ACR20 efficacy, etc., were expressed as n (%), and the chi-square test was performed between the two groups. The rank sum test was performed for the treatment efficacy of the graded data. If the measurement data such as DAS28, ODI, HAQ scores, etc. were in accordance with the normal distribution, they were expressed as An independent sample t test was performed between the two groups. Repeated measurement analysis was performed at multiple time points, and then a LSD-t test was performed between the groups. P<0.05 indicated statistical significance.

[0111] 2 Experimental results

[0112] 2.1 Comparison of ACR20 efficacy between the two groups

[0113] Compared with the control group, the ACR20 efficacy of the study group was higher at 6 and 12 weeks after treatment (P<0.05), as shown in Table 2.

[0114] Table 2 Comparison of ACR20 efficacy between the two groups (n, %)

[0115]

[0116] 2.2 Comparison of TCM symptom scores between the two groups

[0117] Overall, the time point, group, and interaction (time point and interaction) comparisons of TCM symptom scores were statistically significant (P<0.05); LSD-t showed that compared with before treatment, the TCM symptom scores of the two groups decreased 6 weeks and 12 weeks after treatment (P<0.05), and compared with the control group, the TCM symptom scores of the study group were lower 6 weeks and 12 weeks after treatment (P<0.05), see Table 3 and Figure 1 .

[0118] Table 3 Comparison of TCM symptom scores between the two groups

[0119]

[0120] Note: a P<0.05 compared with before treatment. b P<0.05 compared with the control group.

[0121] 2.3 Comparison of inflammatory factors between the two groups

[0122] Overall, the time point, group and interaction (time point and interaction) comparisons of CRP, TNF-α and IL-6 were statistically significant (P<0.05). LSD-t showed that compared with those before treatment, CRP, TNF-α and IL-6 in both groups decreased at 6 and 12 weeks after treatment (P<0.05), and compared with those in the control group, CRP, TNF-α and IL-6 in the study group were lower at 6 and 12 weeks after treatment (P<0.05), as shown in Table 4.

[0123] Table 4 Comparison of CRP, TNF-α, IL-6 between the two groups

[0124]

[0125] Note: a P<0.05 compared with before treatment. b P<0.05 compared with the control group.

[0126] 2.4 Comparison of joint pain, function and quality of life between the two groups

[0127] Overall, the time point, group and interaction (time point and interaction) comparisons of DAS28, ODI and HAQ scores were statistically significant (P<0.05). LSD-t showed that compared with before treatment, the DAS28, ODI and HAQ scores of the two groups decreased at 6 and 12 weeks after treatment (P<0.05), and compared with the control group, the DAS28, ODI and HAQ scores of the research group were lower at 6 and 12 weeks after treatment (P<0.05), as shown in Table 5. Figure 2 and Figure 3 .

[0128] Table 5 Comparison of DAS28, ODI and HAQ scores between the two groups

[0129]

[0130]

[0131] Note: aP<0.05 compared with before treatment. b P<0.05 compared with the control group.

[0132] 3 Conclusion

[0133] RA is a chronic, systemic autoimmune disease with an increasing incidence rate year by year. It has become one of the important diseases that affect people's health and quality of life. Among them, cold-dampness and arthralgia type RA is a classification of the disease in traditional Chinese medicine, which is mainly manifested by joint pain, swelling, and difficulty in flexion and extension. It is aggravated by cold and relieved by heat, which seriously affects the daily life of patients. At present, Western medicine mainly uses non-steroidal anti-inflammatory drugs, immunosuppressants and other drugs to treat cold-dampness and arthralgia type RA, such as Tripterygium wilfordii polyglycosides. Although it can relieve symptoms to a certain extent, long-term use is prone to drug resistance, adverse reactions and other problems, and it is difficult to cure.

[0134] The research results of the present invention show that the ACR20 effective rate of the research group is higher at 6 weeks and 12 weeks after treatment, and the TCM symptom score, CRP, TNF-α, IL-6, DAS28, ODI, and HAQ scores of the research group are lower at 6 weeks and 12 weeks after treatment. It is suggested that the Chinese medicine formula and treatment scheme of the present invention can improve the ACR20 effective rate, improve clinical symptoms, reduce inflammatory factors, relieve joint pain, and improve joint function and quality of life in the treatment of cold-dampness arthralgia type RA.

[0135] The Chinese medicine composition of the present invention is a granule prepared by mixing a variety of Chinese medicinal materials. The medicinal materials such as Herba Piperidissima and Radix Clematis in the prescription have the effect of dispelling wind and dampness, and can relieve joint pain and swelling; Angelica sinensis, Rhizoma Chuanxiong, etc. can relax muscles and activate collaterals, and improve the activity function of joints; and the medicinal materials such as Rhizoma Cynoglossi and Rhizoma Cibotii have the effect of promoting blood circulation and removing blood stasis, which helps to relieve joint pain and bruises. In addition, other ingredients in the formula such as Radix Saposhnikoviae and Rhizoma Cinnamomi can also reconcile qi and blood, enhance the body's resistance, and thus comprehensively improve the symptoms of cold-dampness and arthralgia type RA. Although Tripterygium wilfordii polyglycosides tablets can relieve the symptoms of RA, their mechanism of action is relatively single, mainly for inflammation control, and the pathological mechanism of cold-dampness and arthralgia type RA is complex, involving wind-cold-dampness evil invasion, qi and blood stasis, and other aspects.

[0136] The Chinese medicine composition formula of the present invention has multiple effects such as dispelling wind and cold, removing dampness and unblocking meridians, promoting blood circulation and relieving pain, etc., which can comprehensively regulate the body and improve the condition from multiple levels. Therefore, combining conventional Western medicine treatment with the Chinese medicine formula of the present invention can give play to the complementary advantages of Chinese and Western medicines and improve the therapeutic effect. The Chinese medicinal materials in the formula of the present invention can be holistically conditioned for Chinese medicine syndromes such as wind, cold and dampness, qi and blood stasis, and improve the patient's joint pain, swelling, limited activity and other symptoms. At the same time, Tripterygium wilfordii polyglycosides tablets can assist in controlling inflammation and further alleviate the condition. Therefore, the combined treatment of conventional Western medicine and the formula of the present invention can more comprehensively improve the patient's Chinese medicine syndrome and reduce the Chinese medicine symptom score. The Chinese medicine ingredients in the formula of the present invention can regulate the body's immune function, inhibit the generation and release of inflammatory factors, and reduce inflammatory reactions. At the same time, Tripterygium wilfordii polyglycosides tablets also have a certain anti-inflammatory effect. Therefore, the combined use of conventional Western medicine and the Chinese medicine formula of the present invention can more effectively reduce the level of inflammatory factors, thereby improving the condition. Joint pain and dysfunction are the main symptoms of RA patients.

[0137] The Chinese medicine composition formula of the present invention has multiple effects such as dispelling wind and cold, removing dampness and unblocking meridians, promoting blood circulation and relieving pain. These effects reflect the overall concept of traditional Chinese medicine for disease treatment, that is, the purpose of treating diseases is achieved by regulating the mechanism of yin and yang balance, qi and blood circulation of the body. The formula is holisticly regulated for traditional Chinese medicine syndromes such as wind, cold and dampness, qi and blood stasis, which reflects the in-depth understanding of traditional Chinese medicine for etiology and pathogenesis. By improving the symptoms such as joint pain, swelling, and limited activity of patients, the Chinese medicine formula has played an important role in improving the quality of life of patients. Conventional Western medicine treatment usually focuses on the rapid relief of symptoms and the control of diseases, while traditional Chinese medicine pays more attention to the maintenance of overall conditioning and long-term effects. Combining the two, the respective advantages can be fully utilized to achieve the maximization of the therapeutic effect. As a Western medicine, Tripterygium wilfordii polyglycosides tablets can assist in controlling inflammation, and combined with the comprehensive conditioning effect of the Chinese medicine formula, the condition can be more effectively alleviated.

[0138] The ingredients in this Chinese medicine formula are said to be able to regulate the body's immune function and inhibit the production and release of inflammatory factors, which helps to reduce the inflammatory response and thus improve the condition. At the same time, the anti-inflammatory effect of Tripterygium wilfordii polyglycosides further enhances this effect, making the combined treatment more advantageous in reducing the level of inflammatory factors and improving the condition.

[0139] For patients with RA (rheumatoid arthritis), joint pain and dysfunction are the main symptoms. The combination of Chinese herbal formulas and Western medical treatments is expected to more effectively alleviate these symptoms and improve patients' quality of life through multi-level mechanisms of action.

[0140] The Chinese medicine composition of the present invention has multiple functions such as dispelling wind and dampness, relaxing muscles and tendons, promoting blood circulation and removing blood stasis, clearing away heat and detoxifying, etc., can comprehensively regulate the body, directly act on the joints, improve the blood circulation and nutrition supply of the joints, thereby relieving joint pain and enhancing joint function. Tripterygium wilfordii polyglycoside tablets can assist in relieving joint inflammation and further improve the joint condition of patients. Therefore, the combined use of these two treatment methods can more effectively relieve the joint pain and dysfunction of patients.

[0141] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. Use of a Chinese medicine composition in the preparation of a drug for treating rheumatoid arthritis of the cold-dampness and arthralgia type, characterized in that: The specific application method is as follows: The Chinese medicine composition is administered together with Tripterygium wilfordii polyglycoside tablets and methotrexate tablets. The specific dosage, administration cycle and administration method are as follows: Tripterygium wilfordii polyglycoside tablets: Specification: 10 mg, 3 times a day, 1 tablet each time, orally; Methotrexate tablets: Specification: 2.5 mg, once a week, 4 tablets each time, orally; Chinese medicine composition: Specification: Each gram of granules contains 0.86g of raw medicine, twice a day, 15g each time, orally; The above medications are used for 4 weeks as one course of treatment, for a total of 3 courses; The Chinese medicine composition is composed of the following components by weight: 25-40 parts of Pittosporum tobira wine, 10-15 parts of Pittosporum tobira bark, 20-40 parts of Clematis chinensis, 5-12 parts of Angelica sinensis, 8-15 parts of Ligusticum chuanxiong, 25-35 parts of Cibotium bark, 25-35 parts of Radix Chuanxiong, 25-35 parts of Cyathula capitata, 25-35 parts of Cyathula capitata, 10-20 parts of Eucommia ulmoides, 20-35 parts of Papaya, 10-20 parts of Atractylodes macrocephala, 25-40 parts of Angelica dahurica, 12-20 parts of Viscum album, 15-25 parts of Saposhnikovia divaricata, 8-15 parts of Cassia twig, 2-5 parts of Asarum, 2-5 parts of Scorpio, 5-8 parts of Radix Penicillae Sinensis, 5-8 parts of Frankincense, 5-8 parts of Myrrh, 8-10 parts of Sichuan pepper, 5-8 parts of Beehive, 2-5 parts of Achyranthes bidentata, and 2-5 parts of Licorice.

2. The use according to claim 1, characterized in that: The Chinese medicine composition is composed of the following components by weight: 30 parts of Pittosporum tobira wine, 12 parts of Pittosporum tobira bark, 30 parts of Clematis, 10 parts of Angelica sinensis, 10 parts of Ligusticum chuanxiong, 30 parts of Cibotium bark, 30 parts of Radix Chuanduan, 30 parts of Cyathula officinalis, 15 parts of Eucommia ulmoides, 30 parts of Papaya, 15 parts of Atractylodes macrocephala, 30 parts of Angelica dahurica, 15 parts of Viscum album, 20 parts of Saposhnikovia divaricata, 10 parts of Cassia twig, 3 parts of Asarum, 3 parts of Scorpio, 6 parts of Radix Penicillae Sinensis, 6 parts of Frankincense, 6 parts of Myrrh, 9 parts of Sichuan pepper, 6 parts of Beehive, 3 parts of Achyranthes bidentata, and 3 parts of Licorice.

3. The use according to claim 1, characterized in that: The preparation method of the Chinese medicine composition is as follows: S01 classifying the components of the traditional Chinese medicine composition; S02 extracting components from the Chinese medicine composition classified in step S01; S03: preparing a pharmaceutical preparation from the components extracted in step S02.

4. The use according to claim 3, characterized in that: In step S01, the classification is as follows: Group A: Pitfalls vine (made from wine), Pittosporum tobira bark, and Clematis chinensis; Group B: Chinese Angelica, Chuanxiong, Cibotium barometz, Rhizoma Cynomorii, Rhizoma Cynomorii, Eucommia barometz, and Papaya; Group C: Atractylodes lancea, Angelica dahurica, Morus alba, Saposhnikovia divaricata, Cinnamomum cassia twig, Asarum sieboldii; Group D: Scorpion, Radix Poriae Cibotii, frankincense, myrrh, Sichuan pepper, beehive, dragon fruit, and licorice.

5. The use according to claim 4, characterized in that: The specific steps of step S02 are as follows: Groups A to D are respectively subjected to effective component extraction, and then mixed and concentrated.

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