CN114588242A

CN114588242A - Pharmaceutical composition for treating rheumatoid arthritis

Info

Publication number: CN114588242A
Application number: CN202210399662.5A
Authority: CN
Inventors: 李延萍; 张莹; 尚存芸
Original assignee: Chongqing Traditional Chinese Medicine Hospital
Current assignee: Chongqing Traditional Chinese Medicine Hospital
Priority date: 2022-04-15
Filing date: 2022-04-15
Publication date: 2022-06-07
Anticipated expiration: 2042-04-15
Also published as: CN114588242B

Abstract

The invention relates to the technical field of traditional Chinese medicines, and in particular relates to a pharmaceutical composition for treating rheumatoid arthritis, which comprises 10 parts of cassia twig, 10 parts of white paeony root, 30 parts of astragalus membranaceus, 10 parts of bighead atractylodes rhizome, 15 parts of angelica, 6 parts of turmeric, 10 parts of stiff silkworm, 20 parts of coix seed, 30 parts of suberect spatholobus stem and 15 parts of prepared rehmannia root. In the pharmaceutical composition, the cassia twig and the white paeony root are monarch drugs, the angelica, the astragalus and the bighead atractylodes rhizome are ministerial drugs, the caulis spatholobi is used for strengthening the functions of nourishing blood and promoting blood circulation, the coix seed, the turmeric and the stiff silkworm are used as assistant drugs, and the prepared rehmannia root can prevent the stiff silkworm and the turmeric from being pungent and warm and over-dry. The above herbs have synergistic effect, and are effective in regulating ying and wei, eliminating dampness, invigorating middle warmer, and activating collaterals. The technical problem that a traditional Chinese medicine formula specially used for rheumatoid arthritis and capable of being matched with western medicines is lacked in the market is solved. The pharmaceutical composition can effectively relieve the clinical symptoms of rheumatoid arthritis, improve the immunity, and relieve the toxic and side effects of western medicines, and has great application and popularization values.

Description

Pharmaceutical composition for treating rheumatoid arthritis

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a pharmaceutical composition for treating rheumatoid arthritis.

Background

Rheumatoid Arthritis (RA) is a common autoimmune disease, and belongs to the category of arthralgia syndrome in traditional Chinese medicine. Currently, RA still belongs to a disease with unknown etiology and difficult prevention at home and abroad, so that the exploration of an effective prevention and treatment method for RA is an important subject in the current RA research. Currently, non-steroidal anti-inflammatory drugs (NSAIDs) and slow-acting antirheumatic drugs (DMARDs) are mainly used for treating RA, although the drugs can relieve symptoms and improve the disease condition, the drugs are often required to be applied in a combined way, and the compliance of patients is seriously influenced by the existence of toxic and side effects.

The traditional Chinese medicine has many different schemes for treating RA, has the clinical application and experimental treatment research of single medicine, single traditional Chinese medicine components and formula traditional Chinese medicine, has unique advantages of definite curative effect and good tolerance in treating RA, can play a role in cutting the strong points and tonifying the weak points when being used together with western medicines, and simultaneously better conforms to the clinic psychology of patients. However, in the prior art, the research on the sufficient clinical effectiveness of the formula for treating RA is not available, so that the market is lack of the traditional Chinese medicine formula which is specially used for treating rheumatoid arthritis and can be matched with western medicines.

Disclosure of Invention

The invention aims to provide a pharmaceutical composition for treating rheumatoid arthritis, and aims to solve the technical problem that a traditional Chinese medicine formula which is specially used for treating rheumatoid arthritis and can be matched with western medicines is lacked in the market.

In order to achieve the purpose, the invention adopts the following technical scheme:

a pharmaceutical composition for treating rheumatoid arthritis comprises, by weight, 10 parts of cassia twig, 10 parts of white paeony root, 30 parts of astragalus membranaceus, 10 parts of bighead atractylodes rhizome, 15 parts of angelica sinensis, 6 parts of turmeric, 10 parts of stiff silkworm, 20 parts of coix seed, 30 parts of caulis spatholobi and 15 parts of prepared rehmannia root.

The principle and the advantages of the scheme are as follows:

(1) square solution

Ramulus Cinnamomi and radix Paeoniae alba are selected as the monarch, and ramulus Cinnamomi has effects of regulating yin and yang, and can be used for activating yang and dredging arthralgia, warming channels and dispelling cold and relieving pain; bai Shao is sour and cold in nature, has the actions of tonifying blood, calming liver and alleviating pain, and is commonly used with Gui Zhi, pungent and sweet in flavor and transforming yang to regulate qi of the whole body. The two herbs are combined to obtain the Gui Zhi Tang which is used to harmonize Ying and Wei and also to induce slight sweating and remove wind-damp.

The angelica, the astragalus and the bighead atractylodes rhizome are ministerial, the bighead atractylodes rhizome is bitter and sweet in taste, can eliminate dampness and invigorate spleen, is the warmest in nature, is the first essential drug for tonifying qi of spleen, can eliminate phlegm and remove water, and can relieve the turbidity of joints; the angelica is sweet and warm in nature, enters liver, heart and spleen channels, and has the functions of enriching blood and promoting blood circulation; astragalus root, radix astragali is sweet in flavor, and has the effects of invigorating spleen, replenishing qi, and consolidating superficial resistance. The combination of the astragalus and the white atractylodes rhizome ensures that nutrient-defensive qi and blood are full, the combination of the astragalus and the white angelica can help the potency of the monarch drug to be sufficient, the combination of the astragalus and the white angelica can benefit the defensive qi and nourish nutrient-blood, the combination of the white atractylodes rhizome and the white angelica can eliminate phlegm and turbidity and promote blood stasis, and the combination of the three drugs can ensure that qi and blood are nourished and phlegm and blood stasis are removed.

Caulis Spatholobi is added to strengthen the action of nourishing blood and promoting blood circulation. Coix seed, turmeric and batryticated silkworm are used as adjuvant drugs, and Coix seed records in Ben Cao Jing Jie that' the tendon is in spasm and can not be bent and stretched, wind-damp arthralgia occurs for a long time, qi is discharged, the body is lightened and qi is benefited after long-term administration, and dampness of muscle and dampness of interstitial space are infiltrated; turmeric root tuber, pungent and warm in flavor, has the actions of activating blood and dissipating blood stasis, is the same plant as turmeric root tuber, has the actions of promoting qi circulation and relieving pain, stiff silkworm, pungent and salty in flavor, enters liver meridian, and can activate collaterals and clear channels, dissipate stagnation and relieve swelling. The radix rehmanniae Preparata is added into the three medicines of the coix seed, the turmeric and the stiff silkworm, can prevent the stiff silkworm and the turmeric from being excessively dry due to pungent warm, and can nourish yin and blood. The whole formula firstly regulates ying and wei, is good at resolving dampness, and can be used for invigorating spleen and treating phlegm and blood stasis at the same time, and is matched with worm medicaments for dredging collaterals, so that all pathogens are removed, and healthy qi is not damaged.

(2) Analysis of mechanism

The pathogenesis of RA is mainly wind, cold and damp, and the disease is mainly caused by qi and blood deficiency, nutritional and defensive disorder and internal injury of viscera due to unsmooth channels and collaterals, and the pathogenic factors are combined internally and externally, and long-term phlegm and blood stasis are generated, or the pathogenic factors are caused by cold or wind, and the rheumatoid arthritis is finally formed. In addition to cold and damp pathogens, the deficiency of innate essence and overstrain damage cause weakness of viscera in the Chongqing areas, and exogenous pathogens easily invade the body and stay in the joints and muscles to block meridians and collaterals and unsmooth qi and blood, so that arthralgia syndrome is frequently encountered.

According to the etiology and pathogenesis of the disease, the Lemna minor TCM proposes the following ideas: firstly, the diseases are cured from the qi of the ying-running pulse, the wei-running pulse and the qi of the wei-running pulse, and the diseases are cured from the qi of the wei-running pulse, and the wei-running pulse is not combined with wind, cold and moisture, so the li-Yan-Na is not arthralgia, so the Li-Yan-Na master and ren traditional Chinese medical doctors think that the Li-Yan-Na master and ren traditional Chinese medical doctors are

The inventor discovers through a great deal of research that: whether the qi of ying-wei is smooth or smooth is closely related to the occurrence of wangbi, so it is important to regulate ying-wei in treatment; for treating damp pathogen, yang-warming and spleen-invigorating methods are commonly used because it is usually cold or heat without dampness causing arthralgia; the RA patients use antirheumatic drugs and analgesics for a long time, the spleen and the stomach are vulnerable, and the spleen and the stomach are protected, so that the RA patients can be helped to replenish qi and blood to nourish the joints, the drug damage is reduced, and the compliance of the patients is improved; dampness can cause phlegm and stasis to be generated in a long time, and the three pathogens are stuck together and cannot attack rapidly, violently and singly, so that the dampness needs to be attacked slowly and is supplemented with qi-moving products; timely applying the worm drugs, the nature of blood and flesh can attack the thoroughfare property, yin can use yang, and the worm drugs can enter marrow collaterals, and remove the pathogenic factors of the collaterals to deeply penetrate the disease roots and attack pathogenic accumulation; in the later stage, attention is paid to tonifying liver and kidney, liver governing tendons and kidney governing bones, and liver and kidney deficiency can not only cause wangbi, but also cause lingering pathogen due to deficiency of healthy qi, repeated infection and frequent occurrence and no cure, thereby affecting prognosis. According to years of clinical experience and experimental research, the inventor researches a formula of the scheme, and the formula is based on harmonizing ying and wei and has the functions of resolving dampness, tonifying middle-jiao and activating collaterals.

Malnutrition of the ying-nutrient and blood systems, failure of the wei-defensive qi, failure of the triple energizer to defend them, and failure of qi and blood of the zang-fu organs to circulate can cause damage to the tendons, bones and meridians. The joint, muscle and joint are sore and powerless when qi is lost, and the treatment is to supplement qi and move; for malnutrition, there are numbness of limbs, muscular twitching and tenderness , and muscular atrophy, which is treated by nourishing nutrient and blood. The formula has the effects of benefiting qi, nourishing blood, coordinating ying and dredging collaterals, and realizing the co-regulation of qi and blood to remove arthralgia and relieve pain. The cassia twig and the white paeony root are selected as the monarch in the prescription, and the cassia twig has the effects of regulating yin and yang, promoting yang and freeing paralysis, warming channels and dispelling cold and relieving pain; white peony root, radix Paeoniae alba, sour and cold in nature, has the actions of tonifying blood, calming liver and relieving pain, is commonly used with Gui Zhi, is pungent and sweet in flavor and transforms yang, and can regulate qi of the whole body. The two herbs are combined to obtain the Gui Zhi Tang which is used to harmonize Ying and Wei and is also slightly like sweating and can remove wind-damp. The angelica, the astragalus and the white atractylodes rhizome are ministerial drugs, the white atractylodes rhizome is bitter and sweet in taste, can eliminate dampness and invigorate spleen, has the warmest property, is the first key drug for tonifying qi of spleen, can eliminate phlegm and remove water, and can smooth joint turbidity; the angelica is sweet and warm in nature, enters liver, heart and spleen channels, and has the functions of enriching blood and promoting blood circulation; radix astragali is sweet in flavor, and has effects of invigorating spleen, replenishing qi, and consolidating superficial resistance. The combination of the astragalus and the white atractylodes rhizome ensures that nutrient-defensive qi and blood are full, the combination of the astragalus and the white angelica can help the potency of the monarch drug to be sufficient, the combination of the astragalus and the white angelica can benefit the defensive qi and nourish nutrient-blood, the combination of the white atractylodes rhizome and the white angelica can eliminate phlegm and turbidity and promote blood stasis, and the combination of the three drugs can ensure that qi and blood are nourished and phlegm and blood stasis are removed. With the addition of spatholobus stem, it can strengthen the action of nourishing blood and promoting blood circulation without causing stagnation. Coix seed, turmeric and batryticated silkworm are used as adjuvant drugs, and Coix seed can dry muscle dampness and permeate into striae; turmeric root tuber, pungent and warm in flavor, has the actions of activating blood and dissipating blood stasis, is the same plant as turmeric root tuber, has the actions of promoting qi circulation and relieving pain, stiff silkworm, pungent and salty in flavor, enters liver meridian, and can activate collaterals and clear channels, dissipate stagnation and relieve swelling. Coix seed, turmeric and stiff silkworm are added into the prepared rehmannia root for nourishing yin and blood and preventing the stiff silkworm and the turmeric from being too warm and too dry. The whole formula firstly regulates ying and wei, is good at resolving dampness, and can be used for invigorating spleen and treating phlegm and blood stasis at the same time, and is matched with worm medicaments for dredging collaterals, so that all pathogens are removed, and healthy qi is not damaged.

(3) Clinical observations of conditions

The inventor finds that a series of problems exist in the traditional DMARDs for treating RA in long-term clinical practice, for example, the traditional DMARDs for treating RA has slow effect, and the illness state of a patient cannot be controlled in time; secondly, when DMARDs and NSAIDs are used for a long time, the RA patients have weak spleen and stomach function, and even have gastric ulcer, erosion and other injuries; and thirdly, abnormal liver function and low immunity of patients are easy to occur when DMARDs are used. Therefore, the formula is repeatedly searched and practiced in long-term clinical practice, the formula is summarized and clinical verification is carried out, and the formula for treating RA patients can effectively relieve clinical symptoms, improve the immunity of the patients and reduce the toxic and side effects of western medicines.

Further, the traditional Chinese medicine raw materials of the pharmaceutical composition are prepared by the following method: decocting the Chinese medicinal materials in water to obtain decoction.

Through decoction, the effective components in the traditional Chinese medicinal materials are leached out, so that the bioavailability of the effective components is improved, and the traditional Chinese medicinal materials are convenient for patients to take.

Further, the ratio of the traditional Chinese medicine raw materials to the liquid medicine is 156 g: 450 mL.

The traditional Chinese medicine raw materials with the total mass of 156g are decocted into 450mL liquid medicine, and the liquid medicine is respectively taken by patients three times a day, the concentration of the active ingredients in the liquid medicine is moderate, and the liquid medicine is convenient to take and has high compliance.

Further, the pharmaceutical composition also comprises methotrexate and leflunomide.

Methotrexate and leflunomide are traditional western medicines for treating rheumatoid arthritis, the traditional Chinese medicine and the western medicines are combined for use, the curative effect is increased, and the traditional Chinese medicine components in the scheme have a certain relieving effect on the side effect of the western medicines. The traditional western medicine can cause gastric ulcer, erosion and other injuries, abnormal liver function and low immunity of patients, and the traditional Chinese medicine composition can greatly relieve the phenomena.

Further, the weekly dosage ratio of the traditional Chinese medicine raw materials, the methotrexate and the leflunomide is 1092 g: 7.5 mg: 70 mg. Under the condition of the dosage ratio, the western medicine components and the traditional Chinese medicine components can play the most ideal synergistic effect.

Further, loxoprofen sodium is also included. If the score of the joint tenderness or swelling is more than or equal to 6 points, loxoprofen sodium is added to relieve the symptoms.

Further, the daily dosage ratio of the traditional Chinese medicine raw materials to the loxoprofen sodium is 156 g: 180 mg. The dosage ratio can effectively relieve the joint tenderness or swelling and improve the treatment effect of the rheumatoid arthritis.

The scheme also provides application of the pharmaceutical composition in preparing a medicament for treating the rheumatoid arthritis with the syndrome of deficiency of both qi and blood.

The pharmaceutical composition of the scheme takes the principle of tonifying qi and moving, nourishing ying and blood, and the first method of heavily harmonizing ying and wei promotes the qi and blood in ying and activating vessels to be nourished, the wei and activating vessels to be closed and interstitial space to be internally and externally harmonized, and the meridians and collaterals are smooth, so that the arthralgia syndrome can be cured. The composition balances attack and tonification, flexibly uses various methods of strengthening spleen, regulating liver and tonifying kidney, and is suitable for being matched with worm medicaments to search and eliminate collaterals and evil to deeply penetrate disease roots. The pharmaceutical composition has a remarkable treatment effect on the rheumatoid arthritis with the syndrome of deficiency of both qi and blood, can effectively improve the traditional Chinese medicine symptoms and clinical symptoms of patients with the rheumatoid arthritis by combining the slow-acting antirheumatic drug treatment, reduces ESR (equivalent series resistance) and CRP (common reactive protein receptor) inflammatory indexes, lowers the levels of TNF-alpha and IL-6 proinflammatory factors, and has better treatment effect and good drug safety compared with the treatment by using the slow-acting antirheumatic drug alone.

Drawings

FIG. 1 is a technical route chart of clinical experiments in Experimental example 1.

Detailed Description

The present invention will be described in further detail with reference to examples, but the embodiments of the present invention are not limited thereto. Unless otherwise specified, the technical means used in the following examples and experimental examples are conventional means well known to those skilled in the art, and the materials, reagents and the like used therein are commercially available.

Examples

The pharmaceutical composition for treating rheumatoid arthritis has the following specific formula: 10g of cassia twig, 10g of stiff silkworm, 10g of white paeony root, 6g of turmeric, 30g of astragalus, 10g of bighead atractylodes rhizome, 20g of coix seed, 15g of Chinese angelica, 15g of prepared rehmannia root and 30g of suberect spatholobus stem. It is administered orally at a dose of 150ml each time, 3 times daily. The preparation method comprises the following steps: decocting in a Chinese medicinal preparation room of a hospital by XXXX, and decocting each dose into 3 bags of 150mL each.

Examples of the experiments

The clinical experimental technology roadmap of the experimental example is shown in fig. 1, and the research design adopts a simple random, contrast and non-blind research method. Random numbers were obtained using SPSS15.0 statistical software and selected subjects were assigned randomly to control and experimental groups using a simple randomization procedure. The experimental protocol is as follows:

first, case selection principle

(1) Diagnostic criteria:

(1.1) Western diagnostic standards

RA diagnosis standards issued by the ACR/EULAR combination in 2009 are adopted:

accumulating the number of joints (0-5 points):

1 middle and large joint (0 min); 2-10 middle and large joints (1 minute);

1-3 minor joints (2 min); 4-10 minor joints (3 cents); more than 10 facet joints (5 points).

② serological antibody detection (0-3 points): both RF and anti-CCP antibodies were negative (score 0); at least one low titer positive for RF or anti-CCP (score 2); at least one high titer positive score (score 3) for RF or anti-CCP.

Duration of synovitis (0-1 min): < 6 weeks (0 min); for > 6 weeks (1 min).

Fourthly, acute-phase reactant (0-1 min): CRP and ESR were both normal (score 0); CRP or ESR increased (1 point).

Note: in each section, the highest score is chosen. If a patient has 5 small joints and 4 large joints involved, a score of 3 is obtained. When the sum of the scores obtained from the four parts is greater than or equal to 6, RA is confirmed. Number of affected joints: does not include the distal interphalangeal joint, the first carpometacarpal joint, and the first toe joint; middle and large joints: double shoulder joints, double elbow joints, double hip joints, double knee joints and double manic joints; facet joints: except for the medial and major joints, the remaining joints of the distal interphalangeal joint, the first carpometacarpal joint, and the first -address joint were excluded. Low titers were defined as exceeding the upper normal limit, but not more than 3 times the upper normal limit. High titer is defined as exceeding 3 times the upper normal limit.

(1.2) Chinese medicine diagnostic Standard

The RA Chinese medicine diagnosis standard is formulated according to rheumatoid arthritis diagnosis standard in the Chinese medicine industry standard of the people's republic of China-Chinese medicine syndrome diagnosis curative effect standard, and specifically comprises the following steps:

pain and swelling due to symmetry of the facet joints at the beginning, which are often seen in the finger joints or the back, and are difficult to move and morning stiffness;

slow onset, repeated persistence, and gradual reduction of the weight-reducing effect due to affection of pathogenic wind-cold-dampness;

the joints affected by long-term disease show spindle-shaped swelling, pain during movement, tenderness and tenderness. The later stage of joint deformation, stiffness, smooth surface, atrophy of peripheral muscles, and subcutaneous nodules in a few cases;

rheumatoid factor is positive, and blood sedimentation in attack period can be increased rapidly. The X-ray film can be seen in osteoporosis change, or joint facet dislocation or subluxation after invading candle, bony rigidity, and joint facet fusion.

(1.3) Chinese medicine syndrome diagnostic criteria

Referring to the "common symptoms of rheumatism" and the "syndrome differentiation and treatment part of rheumatoid arthritis" in the 2 nd edition of "practical traditional Chinese medical rheumatology", the types of the disease are as follows:

pattern of wind-damp obstruction: the symptoms include pain, heaviness or swelling of the joints of the limbs, erratic wandering of the pain part, difficulty in bending and stretching of the joints, pale red tongue with white and greasy coating, and soft or slippery pulse.

② cold-dampness obstruction syndrome: the symptoms include cold pain of limbs and joints, emphasis, local swelling, joint spasm, difficulty in flexion and extension, local aversion to cold, severe cold pain, heat pain reduction, no red skin color, swollen tongue, pale dark tongue, white greasy or white slippery coating, and wiry, slow or deep and tense pulse.

③ syndrome of obstruction of damp-heat: the symptoms include local swelling and pain, heaviness, burning or hot sensation of the joints, thirst without desire for drink, vexation, restlessness, fever, red tongue with yellow and greasy coating, and soft-superficial, rapid or smooth and rapid pulse.

Pattern of phlegm-blood stasis obstruction: painful and swollen joints, morning stiffness, difficulty in flexion and extension, nodules around or under the skin, dark purple tongue, white, thick or greasy coating, deep, thready, unsmooth or deep and slippery pulse.

Deficiency of both qi and yin: swollen joints, dry mouth and eyes, dry lips, lassitude, weakness, or emaciation, red tongue with cracks, or swollen tongue with teeth marks, thin and white coating, deep, thready, weak or deep and thready pulse.

Sixthly, deficiency of liver and kidney: arthralgia and myalgia, difficulty in flexion and extension, swelling or rigidity of joints, soreness and weakness of waist and knees, cold joints or local fever, red tongue with thin and white coating, and deep and weak pulse.

Pattern of fatigue, blood obstruction and collateral obstruction: arthralgia, pain at night, stabbing pain, dry and lusterless skin, malaise, dark tongue, petechia on tongue edge and tip, thin and white coating, and thready and unsmooth pulse.

The qi-blood deficiency syndrome: joint muscle soreness and weakness, aggravation after activity, shortness of breath and hypodynamia, palpitation, dizziness, lusterless complexion, muscular atrophy, or joint deformity, pale tongue with thin and white coating, and thready and weak pulse.

(1.4) criteria for determination of active rheumatoid arthritis

By adopting the evaluation standard established by ACR, DAS28 is more than 5.1 and represents the activity of severe diseases, DAS28 is more than 3.2 and less than 5.1 and represents the activity of moderate diseases, DAS28 is more than 2.6 and less than 3.2 and represents the basic remission of diseases, and DAS28 is less than 2.6 and represents the remission of diseases.

(2) Case inclusion criteria, exclusion criteria, discontinuation or withdrawal criteria, culling and shedding criteria

(2.1) case inclusion criteria:

the diagnostic standard of RA diseases is met; the age is 18 years old or older, and the nature is not limited; patients with complete clinical data, including general conditions, syndrome differentiation and typing, treatment and prescription medication; is administered by taking Chinese medicinal decoction.

(2.2) exclusion criteria:

female patients under the age of 18, gestation and lactation; patients with serious primary diseases and mental diseases such as cardiovascular diseases, cerebrovascular diseases, liver diseases, kidney diseases, hemopoietic systems and the like are combined; those with severe gastric or duodenal ulceration or erosion; patients with severe joint deformity, loss of function; patients with other rheumatic diseases; history of joint trauma; those who are intolerant to this drug.

(2.3) abort or exit criteria: "withdrawal case" refers to a case where the entire treatment or follow-up procedure has not been completed. For all included cases of clinical observation, there should be a clear record. The reason for the abort should be faithfully recorded. Reasons for this may include any one or more of the following: severe adverse events (including exacerbations, deaths, teratogenicity, disability, etc.); the investigator required discontinuation of the trial based on the protection of the patient's greatest interest; violation of a treatment regimen; patient non-compliance with study procedures; the patient is pregnant; patient loss of visit; the administrative department requires suspension; the investigator asked for termination.

(2.4) rejection and shedding standards:

removing: cases that should not be counted and that cannot be counted should be eliminated. Such as misdiagnosis, mistaking (patients who entered the study without meeting the inclusion criteria or with meeting the exclusion criteria), use of other medications without physician's consent during the trial, no stem cell therapy, missing or no records, and no statistics. The removed cases should explain the reason, and the record should be kept for future reference and not included in the statistical analysis of the curative effect.

And (3) shedding: cases with incomplete clinical trial protocols should be considered shed. Including patients quitting themselves (if they do not want to continue to receive stem cell therapy, etc.) and doctors quitting them (patients with serious illness who need to add other medicines to affect the judgment of curative effect or patients who need to stop treatment for serious adverse events). The reason of the case should be explained, and the last main curative effect detection result is taken as a final result for statistical analysis. The stem cell treatment records received once should be taken into safety analysis, and all the data of the abscission cases should be kept for future reference.

Second, patient selection

(1) Doctor-patient communication: the designated physician communicates with the patient in detail and signs the doctor-patient communication record and informed consent. Clinical researchers must demonstrate to the patient that participation in the clinical trial is voluntary, and at any stage of the trial have the right to withdraw from the trial at any time without suffering prosecution, that medical treatment and benefits are not affected at all, and that other effective treatments can continue. The patient must be made aware that the personal data involved and under the trial is kept confidential. The patient is also informed of the nature of the clinical trial, the purpose of the trial, the expected possible benefits and the risks and inconveniences that may occur.

(2) Acquiring a medical history: the patient's demographic data, basic condition, past history, complications/diseases and allergies are collected and recorded.

(3) Baseline screening: the baseline screening period is screening before enrollment and requires the following to be completed: signing an informed consent; collecting demographic data and medical history (including usage amount of immunosuppressant and treatment time); vital signs (body temperature, respiration, pulse and blood pressure); clinical symptoms and signs; blood, urine routine, stool occult blood; blood biochemistry (including liver function, kidney function); chest X-ray; disease activity score (DAS28 score); detection of autoantibodies: rheumatoid factor, etc.

(4) Patients were enrolled: patients were selected for inclusion into the group based on whether they signed an informed consent, and inclusion and exclusion criteria, and patients were divided into two groups, control and treatment groups. Each treatment course is 1 month, and the treatment effect and safety are evaluated after the treatment course is finished.

(5) Grouping and treatment protocols

(5.1) control group

(ii) 3 tablets (2.5 mg/tablet) of methotrexate to be administered orally 1 time per week;

② 1 leflunomide tablet (10 mg/tablet), which is taken orally 1 time a day;

and thirdly, taking loxoprofen sodium 1 tablet (60 mg/tablet) 3 times per day (if the joint tenderness or swelling score is more than or equal to 6 minutes, loxoprofen sodium is added).

(5.2) Experimental group

The arthralgia-syndrome-regulating decoction is added on the basis of a control group, and the specific prescription is as follows: 10g of cassia twig, 10g of stiff silkworm, 10g of white paeony root, 6g of turmeric, 30g of astragalus, 10g of bighead atractylodes rhizome, 20g of coix seed, 15g of Chinese angelica, 15g of prepared rehmannia root and 30g of suberect spatholobus stem. It is administered orally at a dose of 150ml each time, 3 times daily. The preparation method comprises the following steps: decocting in Chinese medicinal preparation room of XXXX X hospital, and decocting each dose into 3 bags of 150ml each.

The two treatment courses are 1 month, and the treatment effect and safety evaluation are carried out after 1 month.

Third, observe the index

(1) General items: name, sex, age, past medical history and medication.

(2) Clinical observation index

(2.1) the main symptoms: the number of tenderness and swelling of joints.

(2.2) application of Visual analogue Scale (Visual analogue Scale VAS) score (0-100mm)

The patient was assessed for pain: the VAS is widely used in clinical application in China, the basic method is to use a moving scale with the length of about 10cm, one scale is marked with 10 scales, the two ends of the scale are respectively divided into a 0 point and a 10 point, the 0 point shows no pain, the 10 point shows the most severe pain which is difficult to bear, the scaled one point faces back to a patient in clinical application, the patient marks a corresponding position which can represent the pain degree of the patient on a ruler, a doctor marks the score according to the marked position of the patient, the clinical evaluation is divided into a 0-2 point, a 3-5 point, a 6-8 point and a 8 point according to the scale, the 3-5 point is divided into a good point, the 6-8 point is divided into a ok point and the 8 point is divided into a poor point. The same method can be used for objectively making points before and after clinical treatment, and objectively evaluating the effect of pain treatment. The method is simple and feasible, relatively objective and sensitive. At present, a moving mark is arranged between the '0' end and the '10' end of a common clinical ruler, and scales are arranged on the back surface, so that the ruler is practical and convenient.

(2.2) use of Health Assessment Questionnaire (HAQ)

The HAQ disability index calculation method is an evaluation of the following activities performed in the past 2 months: whether the user can (1) wear clothes (comprising a shoelace and a button) or not, (2) automatically go up and down a bed (3) and automatically carry water to a mouth edge (4) to walk on the flat ground, (5) automatically wash and operate, a body (6) is wiped dry, a faucet or a bottle plug (7) is switched on and off, a comb head (8) cuts vegetables (9), clothes (10) on the ground are picked up, vehicles (11) such as cars and the like go up and down from a chair without supporting the user with hands, and the user stands up (12) to visit a shop and the like. Each score is as follows: 0-point is without any difficulty; 1-point is somewhat difficult and can be accomplished; 2 points are difficult to maintain; 3 points to incomplete. And adding the various phases to obtain a total score.

The HAQ discomfort index calculation method was whether the following sensations were present in the past 2 months: (1) you are not liking work you are doing (2) tension or anxiety (3) dysphoria, difficulty sedating 94 hurting heart or mood lowering, difficulty exciting. Each score is as follows: 0-never; sometimes 1 ═ is; 2-often; 3-always.

The study takes the disability index and the discomfort index and adds the total score into a total score.

(2.3) index of inflammatory Activity

Blood sedimentation: widmans method, normal values: less than or equal to 20 mm/h;

c-reactive protein: rate scattering turbidimetry, normal value: less than or equal to 8 mg/L;

rheumatoid factor: rang coupled adsorption method, normal values: less than or equal to 20 IU/ml;

three values were recorded for each group of patients for comparison before treatment and month 1.

Fourth, evaluation of clinical curative effect

(1) DAS28 efficacy assessment

(1.1) DAS28 score

28 joints of bilateral proximal interphalangeal joints, metacarpophalangeal joints, wrist joints, elbow joints, shoulder joints and knee joints of the patient are examined to obtain the number of Swollen Joints (SJC) and the number of Tender Joints (TJC), and the DAS28 is calculated.

DAS 28: including total joint tenderness, total joint swelling, blood sedimentation, and overall health status evaluation

DAS28＝0.56×√TJC+0.28×√SJC+0.7×lnESR+0.14×GH

Wherein, TJC: number of tender joints; and SJC: swollen joint number; ESR: erythrocyte sedimentation rate (in mm/h); GH: general Health Status (General Health Status) in visual simulation Scale (VAS method, 0-100 mm).

(1.2) DAS28 therapeutic efficacy determination

The effect is shown: after treatment, the DAS28 of the patient is reduced by more than or equal to 1.2;

the method has the following advantages: DAS28 is reduced to 0.6-1.2;

and (4) invalidation: DAS28 reduction < 0.6 or DAS28 greater than 5.1.

(2) ACR efficacy assessment

ACR20 standard: the reduction of the number of joints with swelling and tenderness is more than or equal to 20 percent; and 3 of the following 5 indexes improve the pain scores of the subjects by more than or equal to 20 percent; scoring the overall disease status of the subject; third, the overall disease state VAS of the researcher is scored; health status questionnaire (HAQ), ESR or CRP.

ACR50 standard: the number of swollen and tender joints was reduced by 50% or more and 3 of the following 5 indices were improved by 50% or more (5 indices are as above).

ACR70 standard: the reduction of the number of swollen and tender joints was not less than 70% and the improvement of 3 of the following 5 indices was not less than 70% (5 indices are as above).

Fifth, evaluation of curative effect of traditional Chinese medicine

The integration of the syndrome of traditional Chinese medicine is calculated by adopting a nimodipine method, the curative effect of the syndrome of traditional Chinese medicine is evaluated, and the standard is as follows according to the guiding principle of the clinical research make internal disorder or usurp of new traditional Chinese medicine (2002 edition):

and (3) clinical recovery: clinical symptoms and physical signs disappear or basically disappear, and the syndrome score is reduced by more than or equal to 95 percent.

The effect is shown: the clinical symptoms and physical signs are obviously improved, and the syndrome integral is reduced by more than or equal to 70 percent.

The method has the following advantages: the clinical symptoms and physical signs are improved, and the syndrome integral is reduced by more than or equal to 30 percent.

And (4) invalidation: clinical symptoms and physical signs are not obviously improved or even aggravated, and the syndrome integral is reduced by less than 30%.

Sixthly, inflammatory cytokine detection

The contents of TNF-alpha, IL-6 and IL-10 in peripheral serum are detected by an enzyme-linked adsorption method according to the instruction of a kit. The content values at baseline and 1 month time point were recorded for each group of patients for comparison.

Seven, visit flow

Visit flow: patients in the control group and the treatment group respectively carry out corresponding visit examination 1 month after the first treatment, and the examination content comprises a hematuria routine; liver and kidney function; rheumatoid factor; peripheral serum cytokines, and the like.

Eight, prescription for treatment of complications

Not allowing: treatments considered by the investigator to interfere with the determination of efficacy of the trial are not allowed; no other drug treatment outside the protocol is allowed; other clinical trial drugs are not allowed.

Allowing: the support and symptomatic treatment are allowed to be combined. In the test process, the immunosuppressant for treating diseases should be accurately recorded in a case report table, and the record content comprises start and end dates, treatment modes, dosage and the like.

Nine adverse events, safety measures and emergency plans

Adverse events: all patients were carefully observed for any adverse events that occurred during the clinical study, and their clinical manifestations, severity, time of occurrence, duration, treatment and prognosis were recorded in time. All adverse events were followed until satisfactory results were obtained.

Safety measures and emergency plans:

firstly, taking body-mounting measures: the patient is comprehensively evaluated before treatment, strictly observed in the treatment process, and appropriate symptomatic and auxiliary measures are taken after treatment.

Emergency plan: once an adverse event occurs, such as any adverse medical manifestations of the patient during treatment, all abnormal findings, subjective and objective disease symptoms, complications and accidents, whether or not such events are associated with the present treatment, positive and appropriate treatment should be given.

Ten, inspection

The principal is responsible for the inspection of clinical studies to ensure that clinical study protocols are strictly followed and executed, and the data record sheet and the original data are checked to ensure that the data on the sheet is consistent with the original data, and no errors or falsifications exist.

Eleven, Independent Ethics Committee (IEC)

Prior to the start of the study, the study protocol, informed consent, and relevant patient information and/or advertising must be approved by the Institutional Review Board (IRB). The clinical trial protocol can be modified appropriately in the case of the following cases: to reduce the risk of immediate damage to the study patient, deviation from or modification of the study protocol; any action that increases patient risk and/or significantly affects the performance of the study; all serious and unexpected adverse reactions; new conditions that may adversely affect patient safety or the progress of the study.

Twelve, statistical analysis

And SPSS17.0 software is adopted for data analysis, and the measurement data are expressed by means of average +/-standard deviation. Counting data by X²And (4) testing, wherein t test is adopted for measuring data, and the difference is statistically significant when P is less than 0.05.

Thirteen, experimental results

(1) Clinical efficacy index comparison

Pre-treatment comparisons of TJC, SJC, morning stiffness time, VAS, HAQ scores were statistically not different between the two groups (P >0.05, see tables 1 and 2), with comparable baseline. After 1 month of treatment, TJC, SJC, morning stiffness time, VAS and HAQ scores of the two groups of patients were all significantly improved compared with those before treatment, and the statistical differences were observed (P < 0.05, see tables 1 and 2). After 1 month of treatment, the efficacy of TJC, SJC, morning stiffness, VAS, HAQ scores were superior to the control group with statistical differences (P < 0.05, see tables 1 and 2).

Table 1: comparison of TJC, SJC, morning stiffness time

Note: the group comparison adopts independent sample rank sum test; the group comparison adopts the rank sum test of matched samples, and the group comparison of a control group^*P is less than 0.05, and the comparison in the experimental group is carried out^△P＜0.05。

Table 2: two sets of VAS, HAQ comparisons

Note: the group comparison adopts independent sample rank sum test; the intra-group comparisons used independent sample rank sum tests,

comparison in control group^*P is less than 0.05, and the comparison in the experimental group is carried out^△P＜0.05。

(2) Syndrome integration, main differentiation factors and curative effect comparison in traditional Chinese medicine

Before treatment, the traditional Chinese medicine syndrome integrals and the main syndrome differentiation factors are compared, no statistical difference exists between the two groups (P is more than 0.05, see tables 3 and 4), and the base lines are comparable. After the two groups of patients are treated for 1 month, the medical syndrome integration and the main differentiation factors (arthralgia, arthrocele, morning stiffness, spontaneous perspiration, hypoqi and hypodynamia and numbness) are obviously improved compared with those before treatment, the curative effect of the experimental group is better than that of the control group, and the experimental group has statistical difference (P is less than 0.05, see tables 3 and 4), wherein the hypoqi and hypodynamia has obvious difference (P is less than 0.01, see table 4). After 1 month of treatment, the traditional Chinese medicine syndrome integral effective rate of the experimental group is 86.67 percent, which is 57.14 percent higher than that of the control group, and the statistical difference exists (P is less than 0.05, see table 5).

Table 3: integral comparison of two groups of syndromes

Note: the comparison among groups adopts independent sample t test; in-group comparisons were performed using paired sample t-test.

Table 4: comparison of two groups of major differentiation factors

Table 5: comparison of the two groups of syndrome-integral therapeutic effects

Note: adopting rank sum inspection for grade data; the counting data is tested by X2.

(3) Laboratory index comparison

Comparison of CRP (C-reactive protein), NLR (neutrophil lymphocyte ratio), RF (rheumatoid factor), ESR (erythrocyte sedimentation rate) before treatment did not show any statistical difference between the two groups (P >0.05, see tables 6 and 7), and the baseline was comparable. After 1 month of treatment, the ESR and CRP of the two groups of patients are improved compared with those before treatment, the curative effect of the experimental group is better than that of the control group, and the experimental group has statistical difference (P is less than 0.05, see table 6), while the RF and NLR have no obvious change or statistical difference (P is more than 0.05, see table 7).

Table 6: comparison of laboratory indices between two groups

Note: the group comparison adopts independent sample rank sum test; the group comparison adopts paired sample t test and paired sample rank sum test, and the group comparison in the control group^*P is less than 0.05, and the comparison in the experimental group is carried out^△P＜0.05。

Table 7: comparison of laboratory indices between two groups

Note: the group comparison adopts independent sample rank sum test; the group comparison adopts paired sample t test and paired sample rank sum test, and the group comparison in the control group^*P is less than 0.05, and the comparison in the experimental group is carried out^△P is less than 0.05, and the comparison in the experimental group is carried out^▲P＞0.05。

(4) Disease activity comparison and efficacy comparison

Comparison of DAS28 before treatment showed no statistical difference between the two groups (P >0.05, see table 8), and the baseline was comparable. The DAS28 in both groups were improved after 1 month of treatment, and the experimental group had better curative effect than the control group, with statistical difference (P < 0.05, see Table 8). The effective rate of DAS28 in the experimental group is 83.33% after 1 month of treatment, which is 67.86% higher than that in the control group, and no statistical difference exists (P is more than 0.05, see Table 9).

Table 8: comparison of two sets of DAS28 scores

Note: the group comparison is performed by using an independent sample t test, and the group comparison is performed by using a matched sample t test.

Table 9: comparison of efficacy of two DAS28 scores

Note: adopting rank sum inspection for grade data; the counting data is checked by continuous calibration X2.

(5) Inflammatory cytokine comparison

Comparison before treatment TNF-alpha, IL-6, IL-10 were not statistically different in the two groups (P >0.05, see tables 10 and 11), and the baseline was comparable. After 1 month of treatment, both groups of TNF-alpha and IL-6 were improved, and the efficacy of the experimental group was superior to that of the control group, with statistical differences (P < 0.05, see Table 10), while IL-10 was not significantly changed, and with no statistical differences (P >0.05, see Table 11).

Table 10: comparison of two sets of proinflammatory cytokines

Note: the group comparison adopts independent sample rank sum test, the group comparison adopts paired sample rank sum test, and the control group comparison adopts group comparison^*P is less than 0.05, and the comparison in the experimental group is carried out^△P＜0.05。

Table 11: comparison of two groups of anti-inflammatory cytokines

Note: the group comparison adopts independent sample rank sum test, the group comparison adopts paired sample rank sum test, and the control group comparison adopts group comparison^#P is more than 0.05, and the comparison in the experimental group is carried out^▲P＞0.05。

(5) Evaluation of safety

After the treatment, no obvious abnormality and no change with obvious clinical significance (see tables 12-14) are seen in the routine treatment and liver and kidney function index treatment of hematuria in the two groups, no adverse reaction is caused, and the safety is ensured.

Table 12: two sets of safety comparisons

Table 13: routine comparison of urine before and after treatment

Note: normal/abnormal: normal before treatment, abnormal after treatment; abnormal/normal, abnormal before treatment, normal after treatment; abnormal/abnormal, abnormality before treatment, abnormality after treatment. The normal and abnormal judgment of the index is subject to clinical significance.

Table 14: two sets of normal/abnormal ratio descriptions

Fourteen results analysis

All the cases of rheumatoid arthritis (qi-blood deficiency) in the group were from the rheumatism outpatient service and ward of traditional Chinese medicine institute in Chongqing city of 2021-2022-02 month for 60 cases, and were randomly divided into experimental group and control group, and after 1 month treatment, two groups of patients dropped off 2 cases, which were the control group, 1 case of them required withdrawal by oneself and 1 case of them lost visit. 28 cases of the control group, 1 case of the male and 27 cases of the female, the mean age (55.36 +/-10.76) years and the course (1.88 +/-2.63) years; the experimental group consisted of 30 cases, 1 male and 27 female, the mean age (54.50 + -12.92) years and the course (1.99 + -4.58) years. The RA disease of two groups of patients is in a moderate active stage (DAS28 is more than 3.2 and less than or equal to 5.1), the comparison difference of two groups of general data has no statistical significance, and the baseline is comparable (P is more than 0.05). The study design met the requirements of Helsinki declaration, and the patients and family signed informed consent. All cases met the inclusion exclusion criteria.

The control group adopts simple western medicine treatment, and makes a treatment scheme according to the requirements of domestic diagnosis and treatment guidelines; the experimental group is treated by the composition on the basis of western medicine treatment; the two treatment courses are one month. After the two groups of patients are treated for 1 month, the VAS score, HAQ score, DAS28 score, ESR, CRP, PLT and NLR of the two groups of patients are obviously improved compared with those before treatment, and the differences have statistical significance (P is less than 0.05); compared with the control group after the experimental group is treated for 1 month, the experimental group has better improvements on VAS score, HAQ score and DAS28 score than the control group, and the differences have statistical significance (P is less than 0.05). The pharmaceutical composition can improve the treatment effect of western medicines on rheumatoid arthritis and can also reduce the side effects caused by western medicine treatment.

The inventor believes that whether the qi of ying and wei is smooth or not has causal connection with the onset of rheumatoid arthritis, and the main pathogenesis of the disease is that the yin and blood are obstructed, the wei and qi are obstructed, the triple energizer fails to defend, and qi and blood of viscera are lost in circulation, so that muscles, bones and meridians are injured. Joint and muscle ache and weakness due to qi loss; malnutrition, failure of the body to nourish the vessels, numbness of the limbs and muscular atrophy. On the basis, patients with rheumatoid arthritis are susceptible to exogenous pathogenic factors, breeding endogenous pathogenic factors, and being mixed with various pathogenic factors such as wind, dampness, cold, heat, stasis, phlegm and the like to cause diseases. According to the etiology and pathogenesis of the rheumatoid arthritis, the inventor proposes that the principle of tonifying qi and moving, nourishing ying and blood is adopted for treating the rheumatoid arthritis, and the method of regulating ying and wei is firstly performed, so that qi and blood in ying and activating channels are nourished, the wei and activating channels are dense, the inside and outside are regulated, and the channels and collaterals are smooth, so that the arthralgia can be cured. Meanwhile, cold and heat are separately cleared, deficiency and excess are distinguished, the treatment needs to be balanced and supplemented when the medicine is taken, and various methods of tonifying spleen, regulating liver and tonifying kidney are flexibly used, and the medicine is matched with insect medicines to search and eliminate collaterals and evil so as to deeply penetrate the disease root.

In the prior art, cassia twig, angelica, white paeony root, astragalus, bighead atractylodes rhizome and other medicinal materials are used frequently in the practical operation of treating rheumatoid arthritis. However, the effect of improving the treatment effect of western medicines cannot be met only by using the medicines, the inventor screens more than one kinds of medicines, finds that the medicines (cassia twig, angelica, white paeony root, astragalus and bighead atractylodes rhizome) which are used at high frequency are matched with a core medicine composition (turmeric, stiff silkworm and coix seed), and is assisted with caulis spatholobi to strengthen the effects of nourishing blood and promoting blood circulation and insect medicines to search and remove meridian pathogens, the combined use of the medicines can obtain the synergistic effect, has the effects of tonifying qi and blood, dispelling wind and removing dampness and promoting blood circulation to remove meridian obstruction, and is used in combination with the western medicines, so that the clinical treatment of the rheumatoid arthritis is realized. The decoction prepared by the medicine composition can effectively improve the traditional Chinese medicine symptoms and clinical symptoms of rheumatoid arthritis patients by combining the treatment of the slow-acting antirheumatic, reduce ESR and CRP inflammatory indexes, and lower the levels of TNF-alpha and IL-6 proinflammatory factors, and has better curative effect and good medicine safety compared with the treatment by only using the slow-acting antirheumatic.

In addition to the core drug combination consisting of turmeric, Bombyx Batryticatus and Coicis semen, the inventors have also studied core drug combinations of other compositions, such as: a combination of cortex mori radicis, scutellaria baicalensis and cortex lycii radicis, a combination of scutellaria baicalensis, cassia twig and radix bupleuri, a combination of gentiana macrophylla, radix angelicae pubescentis and frankincense, a combination of almond, forsythia suspensa and erythrina indica lam, a combination of rhizoma anemarrhenae, honeysuckle stem and earthworm, a combination of phaseolus calcaratus, silkworm excrement and cortex acanthopanacis, and a combination of phaseolus calcaratus, silkworm excrement and erythrina indica lam. The candidate core medicine combination is used together with cassia twig, angelica, white paeony root, astragalus, bighead atractylodes rhizome and other medicinal materials with higher medicine frequency and caulis spatholobi, and the treatment effect of the candidate core medicine combination is not better than that of the core medicine combination consisting of turmeric, stiff silkworm and coix seed. The main expression is that the candidate core compositions replace the core drug composition consisting of the turmeric, the stiff silkworm and the coix seed, when the slow-acting antirheumatic drug is combined with the scheme to treat the rheumatoid arthritis, the candidate core compositions show obvious differences compared with the core drug composition consisting of the turmeric, the stiff silkworm and the coix seed in the aspects of reducing ESR (equivalent series resistance), CRP (common reactive protein) inflammatory indexes, reducing TNF-alpha and IL-6 proinflammatory factor levels, improving the traditional Chinese medicine symptoms and clinical symptoms of patients with the rheumatoid arthritis and the like, and the core drug composition consisting of the turmeric, the stiff silkworm and the coix seed has better effect.

The foregoing is merely an example of the present invention and common general knowledge in the art of designing and/or characterizing particular aspects and/or features is not described in any greater detail herein. It should be noted that, for those skilled in the art, without departing from the technical solution of the present invention, several variations and modifications can be made, which should also be regarded as the protection scope of the present invention, and these will not affect the effect of the implementation of the present invention and the practicability of the patent. The scope of the claims of the present application shall be determined by the contents of the claims, and the description of the embodiments and the like in the specification shall be used to explain the contents of the claims.

Claims

1. A pharmaceutical composition for treating rheumatoid arthritis, characterized in that: the traditional Chinese medicine raw materials comprise, by weight, 10 parts of cassia twig, 10 parts of white paeony root, 30 parts of astragalus mongholicus, 10 parts of bighead atractylodes rhizome, 15 parts of Chinese angelica, 6 parts of turmeric, 10 parts of stiff silkworm, 20 parts of coix seed, 30 parts of suberect spatholobus stem and 15 parts of prepared rehmannia root.

2. A pharmaceutical composition for the treatment of rheumatoid arthritis according to claim 1 wherein: the traditional Chinese medicine raw materials are prepared by the following method: decocting the Chinese medicinal materials in water to obtain decoction.

3. The pharmaceutical composition for treating rheumatoid arthritis according to claim 2, wherein the ratio of the traditional Chinese medicine raw materials to the liquid medicine is 156 g: 450 mL.

4. The pharmaceutical composition for the treatment of rheumatoid arthritis according to claim 3, further comprising methotrexate and leflunomide.

5. The pharmaceutical composition for treating rheumatoid arthritis according to claim 3, wherein the dosage ratio of said Chinese herbal medicine raw material, methotrexate and leflunomide per week is 1092 g: 7.5 mg: 70 mg.

6. The pharmaceutical composition for treating rheumatoid arthritis according to claim 5, which further comprises loxoprofen sodium.

7. The pharmaceutical composition for treating rheumatoid arthritis according to claim 6, wherein the daily dosage ratio of the traditional Chinese medicine raw materials to the loxoprofen sodium is 156 g: 180 mg.

8. Use of the pharmaceutical composition according to any one of claims 1 to 7 for the preparation of a medicament for treating rheumatoid arthritis with syndrome of deficiency of both qi and blood.