CN113144062B

CN113144062B - Pharmaceutical composition for treating rheumatoid arthritis and preparation method and application thereof

Info

Publication number: CN113144062B
Application number: CN202010015123.8A
Authority: CN
Inventors: 党万太; 徐丹
Original assignee: Chengdu Medical College
Current assignee: Chengdu Medical College
Priority date: 2020-01-07
Filing date: 2020-01-07
Publication date: 2022-07-19
Anticipated expiration: 2040-01-07
Also published as: CN113144062A

Abstract

The invention provides a pharmaceutical composition, which is prepared from the following raw materials in parts by weight: 10-40 parts of radix angelicae pubescentis, 8-12 parts of asarum, 1-3 parts of radix aconiti preparata, 1-3 parts of radix aconiti kusnezoffii preparata, 6-20 parts of frankincense, 6-20 parts of myrrh, 3-19 parts of ligusticum wallichii, 1-12 parts of arisaema cum bile, 5-25 parts of radix angelicae, 12-30 parts of radix clematidis, 10-30 parts of tripterygium wilfordii, 12-35 parts of caulis spatholobi, 9-25 parts of radix paeoniae alba, 10-45 parts of caulis sinomenii, 0.1-0.3 part of prepared nux vomica, 10-35 parts of elecampane, 10-25 parts of sappan wood, 12-30 parts of radix achyranthis bidentatae, 5-15 parts of safflower carthamus and 10-35 parts of lycopodium clavatum. The invention provides a preparation method and application of the medicine. The composition has obvious curative effect on rheumatoid arthritis and excellent clinical application prospect.

Description

Pharmaceutical composition for treating rheumatoid arthritis and preparation method and application thereof

Technical Field

The invention relates to the field of medicines, in particular to a pharmaceutical composition for treating rheumatoid arthritis and a preparation method and application thereof.

Background

Rheumatoid Arthritis (RA) is an aggressive autoimmune disease, mainly manifested by symmetrical polyarthritis, with high morbidity and teratogenicity. The current etiology of rheumatoid arthritis is not clear, chronic pathological changes can occur in all joints and surrounding tissues of a human body, the pathological changes show symmetrical, multiple and continuous and repeated attacks, inflammation is often red, swollen, painful, joint function is reduced, even malformation is involved in joints, and the heart, the lung, the nervous system and the like can be involved in the later stage. Western medicines mainly comprise non-steroidal anti-inflammatory drugs, antirheumatic drugs, immunosuppressants, glucocorticoids, plant medicines and biological preparations at present, and have certain curative effects but certain adverse reactions after long-term administration.

RA belongs to the categories of arthralgia syndrome and arthralgia in traditional Chinese medicine, and ancient physicians mostly consider that deficiency of vital qi and invasion of exogenous pathogenic factors are the main factors of the pathogenesis of the disease. Just as the theory of Su Wen Bi Lun (plain questions and Bib diseases) says: wind, cold and dampness are mixed and combined to cause arthralgia. "Zhang Jingyueyun: otherwise, all kinds of arthralgia are caused by yin wind, which is always caused by deficiency of true yin and loss of essence and blood, so three qi can be multiplied by each other. When the healthy qi is deficient, wind, cold, dampness and heat will invade the body and cause arthralgia.

With the development of society and science and technology, modern Chinese medical doctors have new and deeper understanding on the etiology and pathogenesis of RA. Doctors propose to treat RA from the spleen, and the key to the attack of the RA is 'spleen deficiency with excessive dampness, turbid phlegm and blood stasis'; some think that cold and dampness are the basic pathological factors of RA, and the zang-fu organs think that the cold and dampness are the most closely related to the spleen, and the key pathogenesis is 'cold-dampness affecting the spleen'; it is proposed that from the viewpoint of kidney treatment of RA, kidney deficiency is the root cause, and arthralgia is the root cause of arthralgia syndrome. It is believed that the disorder of qi and blood in the liver plays an important role in the onset of RA, and loss of blood storage in the liver leads to loss of nourishment of the tendons and vessels, leading to muscle and tendon paralysis; liver qi fails to regulate and dredge, qi movement is blocked, spleen and stomach fail to transport and transform, wood fails to transport and earth fails to transport, water dampness is generated internally due to earth failure, and arthralgia is caused. The idea that RA is caused by autoimmune dysfunction and infection to trigger immune reaction is similar to the idea that RA is caused by autoimmune dysfunction and infection in modern medicine. In conclusion, the pathogenesis of RA is mainly of deficiency in origin and deficiency in excess, the deficiency in origin is deficiency of healthy qi, and is related to the dysfunction of internal organs such as liver, spleen, stomach and kidney, and the excess in origin is exogenous pathogenic factors such as wind, cold, dampness and heat, and internal latent toxin (good Liu, Wan Yuan, Chen Li Hui, Panhui and Liang hong, research progress of the traditional Chinese medicine for treating rheumatoid arthritis [ J ] academic press of shanxi institute of traditional Chinese medicine, 2018,19, (3), 65-68).

The traditional Chinese medicine has long history of treating RA, good curative effect, high safety and has advantages. At present, the traditional Chinese medicine is mainly used for treating rheumatoid arthritis by adopting a traditional Chinese medicine internal treatment method, such as treatment methods of typing, typing and staging, menstruation formula, empirical formula and the like, and the methods mainly use decoction for treating rheumatoid arthritis by oral administration. The oral administration method generally has slow effect, long treatment course and poor patient compliance.

At present, the traditional Chinese medicine external application method is adopted to treat RA, for example, Wanghanton and the like use Daphne plaster to treat 40 cases of cold-dampness arthralgia-block type RA wrist joint diseases, and compared with indomethacin cataplasm group, the detection rate of the wrist joint diseases after treatment of the treatment group is reduced more obviously (Wanghanton, red-fragrant, Jinfangmei, Daphne plaster to treat 40 cases of cold-dampness arthralgia-block type rheumatoid arthritis wrist joint diseases [ J ]. Western traditional Chinese medicine 2016, 29 (10): 107) 109.). The Daphne Giraldii Nitsche plaster mainly comprises dried root bark of Daphne giraldii Nitsche or Daphne tangutica of Thymelaeaceae, and has effects of eliminating pathogenic cold and dampness, promoting blood circulation and relieving pain. According to the research, the Qinshi Xiaobi paste is mainly composed of siegesbeckia orientalis, purslane and tetrandra root, can clear heat, promote diuresis, activate blood, reduce edema, resist inflammation, ease pain and inhibit immunity, can improve the joint symptoms and morning stiffness time of a patient, and has the total effective rate of 86.76%, which is obviously superior to that of a control group (P is less than 0.05). Lishan san and so on adopt traditional Chinese medicine external application to treat phlegm-stasis arthralgia type RA (Lishan san, Zhang Yan, traditional Chinese medicine external application to treat phlegm-stasis arthralgia type rheumatoid arthritis curative effect observation [ J ]. Shanghai acupuncture magazine, 2013, 32 (8): 675) 676.), crude pinellia ternate, crude arisaema root, ephedra herb, rhizoma ligustici wallichii, rhizoma typhonii, white mustard seed, caulis sinomenii, myrrh and frankincense are ground into powder according to a certain proportion, then honey and warm edible plant wood chips are added, stirred uniformly and cooled, and the mixture is locally applied on corresponding acupuncture points, compared with the mixture before treatment, the morning stiffness time and VAS score can be obviously reduced, and the holding power level of hands (P is less than 0.05) can be improved. The external treatment method of the traditional Chinese medicine directly reaches the disease site, has quick response and good curative effect, and embodies the advantages of simplicity, convenience, experience and cheapness of the traditional Chinese medicine.

At present, the Shennong analgesic plaster for external use is available on the market, and can promote blood circulation, remove blood stasis, reduce swelling and relieve pain. Can be used for treating traumatic injury, rheumatic arthralgia, and soreness of waist and back.

More and more effective traditional Chinese medicine compositions are developed and prepared into external preparations for treating rheumatoid arthritis, which is a problem to be solved urgently and has excellent application prospect clinically.

Disclosure of Invention

The invention aims to provide a pharmaceutical composition for treating rheumatoid arthritis, and also provides a preparation method and application of the composition.

The invention provides a pharmaceutical composition for treating rheumatoid arthritis, which is prepared from the following raw materials in parts by weight:

10-40 parts of radix angelicae pubescentis, 8-12 parts of asarum, 1-3 parts of radix aconiti preparata, 1-3 parts of radix aconiti kusnezoffii preparata, 6-20 parts of frankincense, 6-20 parts of myrrh, 3-19 parts of ligusticum wallichii, 1-12 parts of arisaema cum bile, 5-25 parts of radix angelicae, 12-30 parts of radix clematidis, 10-30 parts of tripterygium wilfordii, 12-35 parts of caulis spatholobi, 9-25 parts of radix paeoniae alba, 10-45 parts of caulis sinomenii, 0.1-0.3 part of prepared nux vomica, 10-35 parts of elecampane, 10-25 parts of sappan wood, 12-30 parts of radix achyranthis bidentatae, 5-15 parts of safflower carthamus and 10-35 parts of lycopodium clavatum.

Preferably, the composition is prepared from the following raw materials in parts by weight:

25 parts of pubescent angelica root, 9 parts of asarum, 1 part of prepared monkshood, 1 part of prepared kusnezoff monkshood root, 12 parts of frankincense, 12 parts of myrrh, 9 parts of szechuan lovage rhizome, 6 parts of arisaema cum bile, 15 parts of angelica dahurica, 20 parts of clematis root, 15 parts of common threewingnut root, 20 parts of suberect spatholobus stem, 18 parts of white paeony root, 30 parts of orientvine, 0.1 part of prepared nux vomica, 25 parts of costustoot, 18 parts of sappan wood, 18 parts of twotooth achyranthes root, 10 parts of safflower and 30 parts of common clubmoss herb.

Furthermore, the composition is prepared into a common preparation by adding acceptable auxiliary materials or auxiliary components into the raw powder of the raw materials.

Further, the auxiliary material is vaseline.

Further, the formulation is an external formulation.

Further, the external preparation is emplastrum, tincture, plaster, gel, ointment, lotion, liniment, lotion, plastics, aerosol and spray.

The invention provides a process for preparing said composition comprising the steps of:

a) weighing raw materials in each weight ratio;

b) oven drying, pulverizing, sieving, and stirring;

c) decocting the above materials in water.

Preferably, the first and second electrodes are formed of a metal,

in the step b, the type of the sieve is 80 meshes;

in the step c, adding vaseline while adding water: vaseline: the weight ratio of the medicines is 1.5:0.5:8, decocting for 2-5 minutes.

The invention also provides application of the composition in preparing a medicament for treating rheumatoid arthritis.

The invention provides application of the composition in preparing a medicine for dispelling wind and eliminating dampness, promoting qi circulation and relieving pain, removing blood stasis and reducing swelling, and dredging collaterals and dissipating stagnation.

Rheumatoid arthritis can be clinically manifested as: chronic arthralgia syndrome, pain in joints, pain in the loins and knees, flaccidity, difficulty in flexion and extension of limbs, numbness, spasm of hands and feet, and stagnation of qi and blood.

The inventor considers the etiology to be: it is manifested as swelling and pain of joints, difficulty in flexion and extension of limbs, numbness, spasm of limbs, and stagnation of qi and blood due to pathogenic wind, cold and dampness. Wind-cold-dampness pathogen affecting the joints of the limbs and causing unsmooth circulation of qi and blood, manifested as pain in the waist and knees, difficulty in flexion and extension of the limbs, numbness, spasm of the extremities, and stagnation of qi and blood.

Thus, when administering: dispelling pathogenic wind and eliminating dampness, promoting qi circulation and relieving pain, removing blood stasis and detumescence, dredging collaterals and resolving hard mass.

The medicine composition of the invention mainly uses pubescent angelica root, clematis root, prepared common monkshood mother root, prepared kusnezoff monkshood root and sappan wood as monarch drugs, treats wind with pungent, bitter and warm properties, removes arthralgia and activates and relieves pain. The ministerial drugs comprise asarum, angelica dahurica, safflower, frankincense, myrrh, costustoot and processed nux vomica which are used for removing wind-cold-damp evil from yin channels, removing dampness from channels and collaterals, and activating and relieving pain, dispelling wind and eliminating dampness, and promoting qi circulation and relieving pain. Rhizoma ligustici wallichii, arisaema cum bile, thunder god vine, orienavine and achyranthes root are used as adjuvants for promoting qi circulation, dredging collaterals, eliminating stagnation and relieving pain, and meanwhile, achyranthes root is used for drawing blood and descending to remove blood stasis and relieve spasm pain. The prescription takes the caulis spatholobi, the white paeony root and the lycopodium clavatum as guiding drugs to assist in harmonizing drug properties, and simultaneously remove stasis, dispel wind, relieve pain and relieve numbness of limbs and joints.

The pharmaceutical composition can reduce the levels of DAS28-ESR, DAS28-CRP and DAS28 of rheumatoid arthritis patients, reduce the Richie index and reduce the HAQ score.

The pharmaceutical composition has better treatment effect on patients with rheumatoid arthritis, can improve the disease activity process of the patients with rheumatoid arthritis, has no toxic or side effect of the traditional hormone and non-steroidal anti-inflammatory drug, and has higher effective rate compared with the similar drug Shennong analgesic plaster.

Unless otherwise specified, the definitions of the herbs used in the Chinese medicinal composition of the present invention, such as pubescent angelica root, asarum herb, prepared monkshood, prepared kusnezoff monkshood root, frankincense, myrrh, chuanxiong rhizome, arisaema cum bile, dahurian angelica root, clematis root, common threewingnut root, spatholobus stem, white peony root, orientvine stem, prepared nux vomica, aucklandia root, sappan wood, achyranthes root, safflower and common clubmoss herb, are as described in the Chinese pharmacopoeia.

Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.

Drawings

FIG. 1 is a chart of the analysis of rheumatoid arthritis before and after the treatment of the pharmaceutical composition for rheumatoid arthritis; a is DAS 28-ESR; b: DAS 28-CRP; DAS28 score, and Richie index; HAQ score analysis Table (note: DAS28 represents disease evaluation of rheumatoid arthritis patients; ESR represents erythrocyte sedimentation rate; CRP represents C-reactive protein; HAQ represents health rating Table).

Detailed Description

The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.

EXAMPLE 1 preparation of a composition according to the invention

1. Raw materials: 25g of radix angelicae pubescentis, 9g of asarum, 1g of prepared radix aconiti agrestis, 12g of frankincense, 12g of myrrh, 9g of ligusticum wallichii, 6g of arisaema cum bile, 15g of radix angelicae, 20g of radix clematidis, 15g of tripterygium wilfordii, 20g of caulis spatholobi, 18g of radix paeoniae alba, 30g of caulis sinomenii, 0.1g of prepared nux vomica, 25g of radix aucklandiae, 18g of sappan wood, 18g of radix achyranthis bidentatae, 10g of safflower and 30g of lycopodium clavatum.

2. The preparation method comprises the following steps:

a) weighing the raw materials in the weight ratio;

b) oven drying, pulverizing, sieving with 80 mesh sieve, and stirring;

c) taking a proper amount of the medicine, adding water and vaseline, wherein the weight ratio of water: vaseline: the weight ratio of the medicines is 1.5:0.5:8, decocting for about 4 minutes to make the liquid medicine thick like a paste, and cooling for later use.

Example 2 preparation of a composition according to the invention

1. Raw materials: 10g of pubescent angelica root, 8g of asarum, 1g of prepared monkshood, 1g of prepared kusnezoff monkshood root, 6g of frankincense, 6g of myrrh, 3g of szechuan lovage rhizome, 1g of arisaema cum bile, 5g of angelica dahurica, 12g of clematis root, 10g of common threewingnut root, 12g of suberect spatholobus stem, 9g of white paeony root, 10g of orientvine, 0.1g of prepared nux vomica, 10g of costustoot, 10g of sappan wood, 12g of twotooth achyranthes root, 5g of safflower and 10g of common clubmoss herb

2. The preparation method comprises the following steps:

a) weighing raw materials in each weight ratio;

b) oven drying, pulverizing, sieving with 80 mesh sieve, and stirring;

c) taking the medicine, adding water and vaseline, wherein the weight ratio of water: vaseline: the weight ratio of the medicines is 1.5:0.5:8, decocting for 2 minutes to ensure that the liquid medicine is thick and pasty, and cooling for later use.

Example 3 preparation of a composition according to the invention

1. Raw materials: 20g of radix angelicae pubescentis, 10g of asarum, 2g of prepared radix aconiti agrestis, 10g of frankincense, 10g of myrrh, 8g of ligusticum wallichii, 5g of arisaema cum bile, 10g of radix angelicae, 15g of radix clematidis, 15g of tripterygium wilfordii, 20g of caulis spatholobi, 15g of radix paeoniae alba, 20g of caulis sinomenii, 0.1g of prepared nux vomica, 15g of radix aucklandiae, 15g of sappan wood, 20g of radix achyranthis bidentatae, 10g of safflower and 20g of lycopodium clavatum.

2. The preparation method comprises the following steps:

a) weighing raw materials in each weight ratio;

b) oven drying, pulverizing, sieving with 80 mesh sieve, and stirring;

c) taking medicine, adding water and vaseline, wherein the water: vaseline: the weight ratio of the medicines is 1.5:0.5:8, decocting for 3 minutes to make the liquid medicine thick like a paste, and cooling for later use.

Example 4 preparation of a composition according to the invention

1. Raw materials: 30g of radix angelicae pubescentis, 10g of asarum, 3g of prepared radix aconiti agrestis, 15g of frankincense, 15g of myrrh, 15g of ligusticum wallichii, 10g of arisaema cum bile, 20g of radix angelicae, 20g of radix clematidis, 20g of tripterygium wilfordii, 25g of caulis spatholobi, 20g of radix paeoniae alba, 30g of caulis sinomenii, 0.2g of prepared nux vomica, 20g of radix aucklandiae, 20g of sappan wood, 25g of radix achyranthis bidentatae, 12g of safflower and 25g of lycopodium clavatum.

2. The preparation method comprises the following steps:

a) weighing raw materials in each weight ratio;

b) oven drying, pulverizing, sieving with 80 mesh sieve, and stirring;

c) taking the medicine, adding water and vaseline, wherein the weight ratio of water: vaseline: the weight ratio of the medicines is 1.5:0.5:8, decocting for 3 minutes to make the liquid medicine thick like a paste, and cooling for later use.

EXAMPLE 5 preparation of the composition of the invention

1. Raw materials: 40g of radix angelicae pubescentis, 12g of asarum, 3g of prepared radix aconiti agrestis, 20g of frankincense, 20g of myrrh, 19g of ligusticum wallichii, 12g of arisaema cum bile, 25g of radix angelicae, 30g of radix clematidis, 30g of tripterygium wilfordii, 35g of caulis spatholobi, 25g of radix paeoniae alba, 45g of caulis sinomenii, 0.3g of prepared nux vomica, 35g of elecampane, 25g of sappan wood, 30g of radix achyranthis bidentatae, 15g of safflower and 35g of lycopodium clavatum.

2. The preparation method comprises the following steps:

a) weighing raw materials in each weight ratio;

b) oven drying, pulverizing, sieving with 80 mesh sieve, and stirring;

c) taking the medicine, adding water and vaseline, wherein the weight ratio of water: vaseline: the weight ratio of the medicines is 1.5:0.5:8, decocting for 5 minutes to make the liquid medicine thick like a paste, and cooling for later use.

Test example 1 therapeutic effects of the composition of the present invention

1 clinical data

1.1 general data 98 hospitalized RA patients who took a visit from the rheumatological department of the first affiliated hospital of the Chengdu medical college from 2019, 1 month to 2019, were selected and divided into a treatment group and a control group according to a random digital table method, and 49 patients were selected in each group. 12 men and 37 women in the treatment group; age 23-61 years, mean (43.26 Shi 4.62) years; the disease course is 0.5-13 years, and the average (4.54 days 0.27) year. 9 men and 40 women in the control group; age 24-65 years, mean (50.21+7.44) years; the disease course is 0.5-14 years, and the average (5.49 days and 0.27) year. Compared with the patients in 2 groups in terms of sex, age, disease course and the like, the difference has no statistical significance (P is more than 0.05) and is comparable.

1.2 diagnostic criteria RA classification criteria as established by the American College of Rheumatology (ACR) in 2009 were followed.

1.3 inclusion standards ((1) meeting the diagnosis standards, (2) being 18-75 years old with unlimited sex, (3) not using hormone or non-steroidal anti-inflammatory drug, (4) agreeing to accept blood drawing and other related examination and treatment persons, and (5) agreeing to sign an informed consent and completing the follow-up.

1.4 exclusion criteria (1) pregnant or lactating women; (2) patients with other immune system diseases are combined; (3) those with severe diseases of liver, kidney, cardiovascular system, hematopoietic system, etc.; (4) skin ulcer of joints or severe extraarticular manifestations, such as hyperpyrexia, central nervous system lesions, etc.; (5) those allergic to the drug components in this study.

2 method

2.1 treatment methods the control group was administered with Shennong analgesic plaster (Zhanjiang Jimin, pharmaceutical Co., Ltd., Guangdong) by external application (one plaster in the morning and at night, one plaster for 4-6 h). The observation group was administered the pharmaceutical composition prepared in example 1 of the present invention, applied to a gauze, and applied to the pain area (one patch in the morning and evening, one patch for 4-6 hours).

2.2 Observation index (1) comparing the effective treatment rate of two groups of patients; (2) the observation groups were compared for DAS28-ESR, DAS28-CRP, DAS28, Richie index, HAQ score, before treatment and after 72h, 1, 2 weeks post-treatment.

3 results of

The experimental results are shown in figure 1, DAS28-ESR is obviously reduced (P is less than 0.05) (A) after 1 and 2 weeks of treatment by the pharmaceutical composition of the invention compared with that before the treatment;

DAS28-CRP is remarkably reduced (P is less than 0.05) (B) after 72h, 1 and 2 weeks after treatment by the pharmaceutical composition of the invention compared with that before treatment;

after 1 and 2 weeks of treatment by the pharmaceutical composition, DAS28 score is remarkably reduced (P is less than 0.05) (C) compared with that before treatment;

after 1 and 2 weeks of treatment by the pharmaceutical composition, the Riche index is obviously reduced (P is less than 0.01) compared with that before treatment, and after 72 hours of treatment by the pharmaceutical composition, the Riche index is obviously reduced (P is less than 0.05) (D) compared with that before treatment;

richie index after 1 and 2 weeks of treatment with the pharmaceutical composition of the inventionCompared with the prior treatment, the HAQ score is remarkably reduced (P is less than 0.05) after 72 hours of treatment by the pharmaceutical composition of the invention (E);^*P＜0.01，^**P＜0.01。

the effective rate of an observation group after the treatment of the pharmaceutical composition is obviously higher than that of a control group (5 patients in the control group are lost, and 44 patients in the final group are patients in the control group), (P is less than 0.05) (Table 1).

Table 1 clinical therapeutic efficacy of the pharmaceutical compositions of the present invention

4 conclusion

The pharmaceutical composition can reduce the levels of DAS28-ESR, DAS28-CRP and DAS28 of rheumatoid arthritis patients, reduce the Richie index and reduce the HAQ score. And as the time of administration increased, there was a significant decrease in the corresponding index. In addition, the clinical effective rate of the pharmaceutical composition is as high as 95 percent, which is far higher than that of a control group.

In conclusion, the pharmaceutical composition has better treatment effect on patients with rheumatoid arthritis, can improve the disease activity process of the patients with rheumatoid arthritis, has no toxic or side effect of the traditional hormone and the non-steroidal anti-inflammatory drug, and has higher effective rate compared with the similar drug Shennong Zhentong Gao. Has good clinical application prospect.

Claims

1. A pharmaceutical composition for treating rheumatoid arthritis is characterized in that: the traditional Chinese medicine is prepared from the following raw materials in parts by weight:

25 parts of pubescent angelica root, 9 parts of asarum, 1 part of prepared monkshood, 1 part of prepared kusnezoff monkshood root, 12 parts of frankincense, 12 parts of myrrh, 9 parts of szechuan lovage rhizome, 6 parts of arisaema cum bile, 15 parts of angelica dahurica, 20 parts of clematis root, 15 parts of common threewingnut root, 20 parts of suberect spatholobus stem, 18 parts of white paeony root, 30 parts of orientvine stem, 0.1 part of prepared nux vomica, 25 parts of costustoot, 18 parts of sappan wood, 18 parts of twotooth achyranthes root, 10 parts of safflower and 30 parts of common clubmoss herb.

2. The composition of claim 1, wherein: the preparation is prepared from the raw powder of the raw materials and acceptable auxiliary materials or auxiliary components into a common preparation.

3. The composition of claim 2, wherein: the auxiliary material is vaseline.

4. The composition of claim 2, wherein: the formulation is an external formulation.

5. A method of preparing the composition of any one of claims 1-4, wherein: it comprises the following steps:

a) weighing raw materials in each weight ratio;

b) oven drying, pulverizing, sieving, and stirring;

c) decocting the above materials in water.

6. The method according to claim 5, wherein:

in the step b, the type of the sieve is 80 meshes;

in the step c, vaseline is added while water is added, wherein the weight ratio of the water to the vaseline to the medicines is 1.5:0.5:8, and the decocting time is 2-5 minutes.

7. Use of a composition according to any one of claims 1 to 4 in the manufacture of a medicament for the treatment of rheumatoid arthritis.