CN107233430B

CN107233430B - Traditional Chinese medicine composition for treating rheumatoid arthritis

Info

Publication number: CN107233430B
Application number: CN201610180273.8A
Authority: CN
Inventors: 侯丽萍; 石秀峰
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-03-28
Filing date: 2016-03-28
Publication date: 2021-03-16
Anticipated expiration: 2036-03-28
Also published as: CN107233430A

Abstract

The invention relates to a traditional Chinese medicine composition for treating rheumatoid arthritis, which comprises the following raw material medicines: 50-210 parts of tripterygium wilfordii, 5-50 parts of radix rehmanniae recen, 10-90 parts of rhizoma atractylodis, 10-90 parts of honeysuckle stem, 10-90 parts of caltrop, 25-120 parts of codonopsis pilosula and 10-30 parts of medlar; wherein the ratio of the tripterygium wilfordii to the medlar is 5-7: 1. Clinical research shows that the composition has a total clinical effective rate of 95.6 percent on rheumatoid arthritis, can effectively relieve related symptoms, and is safe and effective.

Description

Traditional Chinese medicine composition for treating rheumatoid arthritis

Technical Field

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

Background

Rheumatoid arthritis is a chronic systemic autoimmune disease mainly caused by arthropathy, and often has erosive changes of joints and progressive joint deformity, the disability rate is high, and the work, the living capacity and the life quality of patients are seriously influenced. Currently, antirheumatic western medicines for treating rheumatoid arthritis mainly include three major types, namely non-steroidal anti-inflammatory drugs, slow-acting antirheumatic drugs and adrenocortical hormones. The non-steroidal drugs are the most applied drugs at present, although the symptoms can be rapidly relieved, the non-steroidal drugs cannot prevent the progress of diseases, and the toxic and side effects such as gastrointestinal reaction, blood system damage and the like are large; although the slow-acting antirheumatic has a certain control effect on the progress of the disease, the curative effect is late, and the chronic antirheumatic has large toxic and side effects on the aspects of liver, kidney, blood system and the like after being taken for a long time; glucocorticoid drugs have strong anti-inflammatory effects and can rapidly relieve symptoms of patients with rheumatoid arthritis, but due to certain knowledge of application of hormones, misuse and abuse of the drugs in current clinical work are quite common, and serious adverse consequences are often caused to the patients. Therefore, it is necessary to further search for more effective and safer drugs and methods in the field of traditional Chinese medicine.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for treating rheumatoid arthritis;

the other purpose of the invention is to provide a preparation method of the traditional Chinese medicine composition;

the third purpose of the invention is to provide the application of the traditional Chinese medicine composition in preparing the medicine for treating rheumatoid arthritis.

The purpose of the invention is realized by the following technical scheme:

a traditional Chinese medicine composition for treating rheumatoid arthritis comprises the following raw medicines: 50-210 parts of tripterygium wilfordii, 5-50 parts of radix rehmanniae recen, 10-90 parts of rhizoma atractylodis, 10-90 parts of honeysuckle stem, 10-90 parts of caltrop, 25-120 parts of codonopsis pilosula and 10-30 parts of medlar;

wherein the ratio of the tripterygium wilfordii to the medlar is 5-7: 1.

Further, the composition comprises the following raw material medicaments: 70-160 parts of tripterygium wilfordii, 8-30 parts of radix rehmanniae recen, 15-60 parts of rhizoma atractylodis, 15-60 parts of honeysuckle stem, 15-60 parts of caltrop, 30-90 parts of codonopsis pilosula and 11-25 parts of wolfberry fruit.

Furthermore, the composition comprises the following raw material medicaments: 90-120 parts of tripterygium wilfordii, 10-25 parts of radix rehmanniae recen, 20-50 parts of rhizoma atractylodis, 20-50 parts of honeysuckle stem, 20-50 parts of caltrop, 40-70 parts of codonopsis pilosula and 12-23 parts of wolfberry fruit.

Furthermore, the composition comprises the following raw material medicaments: 104.7 parts of tripterygium wilfordii, 16.8 parts of radix rehmanniae recen, 33.6 parts of rhizoma atractylodis, 33.6 parts of honeysuckle stem, 33.6 parts of caltrop, 56 parts of codonopsis pilosula and 20 parts of medlar;

or, the composition comprises the following raw material medicaments: 98 parts of tripterygium wilfordii, 20 parts of radix rehmanniae recen, 45 parts of rhizoma atractylodis, 25 parts of honeysuckle stem, 45 parts of caltrop, 60 parts of radix codonopsitis and 14 parts of medlar;

or, the composition comprises the following raw material medicaments: 110 parts of tripterygium wilfordii, 12 parts of radix rehmanniae recen, 45 parts of rhizoma atractylodis, 25 parts of honeysuckle stem, 45 parts of caltrop, 50 parts of radix codonopsitis and 22 parts of medlar.

Further, the traditional Chinese medicine composition can be powder obtained by directly crushing the raw materials, or can be an extract obtained by extracting according to a conventional extraction method, or an effective part obtained by further refining and purifying the extract, or can be a conventional oral preparation obtained by further preparing according to a conventional preparation process;

wherein the conventional extraction method comprises soaking extraction, decoction extraction, reflux extraction, percolation extraction, ultrasonic extraction, etc.; the extraction solvent comprises water and 20-95% ethanol solution; the refining and purifying process comprises water extraction and alcohol precipitation, extraction, silica gel chromatographic column separation, macroporous resin column separation and the like; the conventional oral dosage forms comprise powder, tablets, capsules, granules, oral liquid, pills and the like.

In order to make the above dosage forms possible, pharmaceutically acceptable excipients, such as: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, bases, and the like. The filler comprises: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, etc.; the disintegrating agent comprises: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, crospolyvinylpyrrolidone, low-substituted hydroxypropylcellulose, croscarmellose sodium, etc.; the lubricant comprises: magnesium stearate, sodium lauryl sulfate, talc, silica, and the like; the suspending agent comprises: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, and the like; the adhesive comprises: starch slurry, polyvinylpyrrolidone, hydroxypropylmethylcellulose, and the like; the sweetener comprises: saccharin sodium, aspartame, sucrose, sodium cyclamate, glycyrrhetinic acid, and the like; the flavoring agent comprises: sweeteners and various essences; the preservative comprises: parabens, benzoic acid, sodium benzoate, sorbic acid and its salts, benzalkonium bromide, chloroacetidine acetate, eucalyptus oil, etc.; the matrix comprises: PEG6000, PEG4000, insect wax, etc. In order to realize the traditional Chinese medicine pharmacy, other pharmaceutically acceptable auxiliary materials (auxiliary materials recorded in each dosage form in the 12 th month and 1 st edition of Shanghai science Press 1997) are required to be added when preparing the dosage forms.

The traditional Chinese medicine composition can be fed in the form of an extract (effective part) besides the raw medicinal materials of tripterygium wilfordii, radix rehmanniae recen, rhizoma atractylodis, honeysuckle stem, caltrop, codonopsis pilosula and medlar, so that the invention further discloses a traditional Chinese medicine composition for treating rheumatoid arthritis:

a traditional Chinese medicine composition for treating rheumatoid arthritis comprises the following raw medicines: 50-210 parts of tripterygium wilfordii extract, 5-50 parts of radix rehmanniae extract, 10-90 parts of rhizoma atractylodis extract, 10-90 parts of honeysuckle stem extract, 10-90 parts of tribulus terrestris extract, 25-120 parts of radix codonopsis extract and 10-30 parts of medlar extract;

wherein the ratio of the tripterygium wilfordii extract to the medlar extract is 5-7: 1.

Further, the composition comprises the following raw material medicaments: 70-160 parts of tripterygium wilfordii extract, 8-30 parts of radix rehmanniae extract, 15-60 parts of rhizoma atractylodis extract, 15-60 parts of honeysuckle stem extract, 15-60 parts of tribulus terrestris extract, 30-90 parts of codonopsis pilosula extract and 11-25 parts of medlar extract.

Furthermore, the composition comprises the following raw material medicaments: 90-120 parts of tripterygium wilfordii extract, 10-25 parts of radix rehmanniae extract, 20-50 parts of rhizoma atractylodis extract, 20-50 parts of honeysuckle stem extract, 20-50 parts of tribulus terrestris extract, 40-70 parts of codonopsis pilosula extract and 12-23 parts of medlar extract.

Furthermore, the composition comprises the following raw material medicaments: 104.7 parts by weight of tripterygium wilfordii extract, 16.8 parts by weight of radix rehmanniae extract, 33.6 parts by weight of rhizoma atractylodis extract, 33.6 parts by weight of honeysuckle stem extract, 33.6 parts by weight of tribulus terrestris extract, 56 parts by weight of radix codonopsitis extract and 20 parts by weight of medlar extract;

or, the composition comprises the following raw material medicaments: 95 parts of tripterygium wilfordii extract, 20 parts of radix rehmanniae extract, 45 parts of rhizoma atractylodis extract, 25 parts of honeysuckle stem extract, 45 parts of tribulus terrestris extract, 60 parts of codonopsis pilosula extract and 14 parts of medlar extract;

or, the composition comprises the following raw material medicaments: 110 parts of tripterygium wilfordii extract, 12 parts of radix rehmanniae extract, 45 parts of rhizoma atractylodis extract, 25 parts of honeysuckle stem extract, 45 parts of tribulus terrestris extract, 50 parts of codonopsis pilosula extract and 22 parts of medlar extract.

The extracts are respectively water extracts or water-miscible organic solvent extracts of tripterygium wilfordii, radix rehmanniae recen, rhizoma atractylodis, honeysuckle stem, caltrop, codonopsis pilosula and medlar; further, the organic solvent which is mutually soluble with water is 20-95% ethanol solution. The conventional extraction method comprises immersion extraction, decoction extraction, reflux extraction, percolation extraction, ultrasonic extraction and the like.

Tripterygium wilfordii in the prescription is pungent and bitter in flavor and cold in nature, is a monarch drug in the prescription, and can clear away heat and toxic materials, dispel wind and remove dampness, and dredge collaterals and relieve pain; the dried rehmannia root is used for cooling blood, the rhizoma atractylodis is used for eliminating dampness, and the two medicines are combined to be used as ministerial medicines for assisting the tripterygium wilfordii in dispelling wind and removing dampness; honeysuckle stem is used for clearing heat, and caltrop is used for dispelling wind, so as to dredge collaterals and relieve pain; codonopsis pilosula promotes the production of body fluid and nourishes blood; uses medlar as a guide to tonify liver and kidney, regulate and slow body resistance, inhibit toxicity of tripterygium wilfordii, enhance efficacy and remove toxicity. The medicines are combined to tonify qi and nourish yin, detoxify and dredge collaterals, and are used for treating arthralgia syndrome of deficiency of both qi and yin and deficiency-excess mixed type.

Clinical research shows that the composition has a total clinical effective rate of 95.6 percent on rheumatoid arthritis, can effectively relieve related symptoms, and is safe and effective.

Experimental example 1 Observation of clinical efficacy

Among patients in the Jinsong hospital, the clinical investigation was randomly conducted on the curative effect and safety of 300 patients with rheumatoid arthritis, and the results are summarized as follows:

1 Observation case selection criteria

The method adopts western medicine diagnosis and traditional Chinese medicine syndrome differentiation to select and observe cases:

1.1 Western diagnostic criteria: the American college of rheumatology (ARA) revised in 1987 was used.

1.2 the traditional Chinese medicine syndrome differentiation standard: the Chinese medicine syndrome diagnosis standard adopts the clinical research guiding principle of new Chinese medicine for treating rheumatoid arthritis.

Syndrome of obstruction of blood stasis and blood

The main symptoms are: swelling and stabbing pain in joints, or pain at night, difficulty in flexion and extension of joints, morning stiffness, and joint deformity.

The secondary symptoms are as follows: subcutaneous scleromere, dull and gloomy local skin color of joints, dry and lusterless skin, or scaly skin, scanty menstruation or amenorrhea.

Tongue pulse: the tongue is purple and dark with ecchymosis or petechia, and the pulse is deep, thready and unsmooth.

1.3 inclusion case criteria:

1) meets the diagnostic standard of western medicine.

2) Accords with the traditional Chinese medicine syndrome diagnosis standard.

3) Age 16-65 years;

4) patients receiving nsaid and hormone therapy are stable for at least 30 days prior to testing and remain unchanged for subsequent treatments. Patients receiving other disease-improving drugs must discontinue administration for more than 30 days.

1.4 rule of exclusion:

1) those that do not meet the inclusion criteria.

2) Patients with advanced stage, severe deformity of joints, and grade IV joint function.

3) Overlapping other rheumatic diseases such as systemic lupus erythematosus, sjogren's syndrome, severe knee osteoarthritis, etc.

4) Complicated with severe diseases of heart, brain, liver, kidney and hematopoietic system.

5) Pregnant or lactating women, psychopath, etc.

2 clinical Observation index

2.1 safety observation indexes:

1) general physical examination item examination.

2) And (5) performing routine examination on blood, urine and feces.

3) And (5) checking the functions of the heart, the liver and the kidney.

4) Possible gastrointestinal reactions were observed.

2.2 observation indexes of curative effect:

1) major associated symptoms

Joint pain, joint swelling, joint flexion and extension difficulty, morning stiffness (min) and related manifestations.

2) Major related physical signs

The number of tenderness in joints, the number of swelling in joints (calculated for pain in joints and swelling in joints 28 joints in the proximal interphalangeal, metacarpal-phalangeal, wrist, elbow, shoulder and knee joints on both sides), the joint function, the average grip strength of both hands (mmHg), pain, X-ray cycle of joints, morning stiffness.

3) Physical and chemical inspection

Joint X-ray examination, RF, ESR, CRP.

3, clinical data:

3.1 general data:

300 patients in outpatient and inpatient cases of the group were randomly selected according to the inclusion case standard, wherein 246 women, 54 men and women: male, about 4.6: 195 cases with the age of 16-40 years, 78 cases with the age of 41-60 years, 27 cases with the age of more than 60 years, 9 cases with the age of 20-35 years as the peak age of onset, 9 cases with the course of disease less than 1 year, 192 cases with the age of 1-5 years, 87 cases with the age of 6-10 years, and 12 cases with the age of more than 10 years.

3.2 data of disease conditions:

1) general physical examination: before and after 300 cases of treatment, physical examination is carried out on the patients in the group, and no obvious abnormal change is found in the heart, the lung, the liver, the spleen and the nervous system of vital signs.

2) And (3) conventional assay results: no obvious abnormality is found in 300 cases of routine tests before and after treatment, blood, urine, stool routine, electrocardiogram and liver and kidney function examination.

4, treatment method:

the oral liquid prepared in example 1 was administered orally according to the disease condition. The traditional Chinese medicine is taken 20ml at a time, 3 times a day, and 8-12 weeks after meals are taken as a treatment course. In the observation process, the observation case should not take the Chinese and western medicines for the main indications of the above-mentioned diseases and adopt other treatment methods aiming at the above-mentioned diseases.

5 therapeutic efficacy criteria

5.1 criteria for the therapeutic efficacy of a disease

1) The overall improvement rate of the main symptoms and physical signs is more than or equal to 75 percent. The blood sedimentation and C-reactive protein are normal or obviously improved or close to normal.

2) The overall improvement rate of the main symptoms and physical signs is more than or equal to 50 percent. The blood sedimentation and C-reactive protein are improved.

3) The overall improvement rate of effective main symptoms and physical signs is more than or equal to 30 percent. There was improvement or no improvement in blood sedimentation and C-reactive protein.

4) The overall improvement rate of the main symptoms and signs is less than 30 percent. There was no improvement in blood sedimentation and C-reactive protein.

Attached: the main symptoms and signs refer to joint tenderness, joint swelling, morning stiffness (min), average holding power (mmHg) of hands and pain, and the overall improvement rate refers to the improvement percentage of the above 5 indexes, i.e., [ (pre-treatment value-post-treatment value)/pre-treatment value ] × 100%, and then the average value is obtained after adding.

5.2 criteria for determining the therapeutic effects of syndrome

1) The clinical cure is as follows: the clinical symptoms and physical signs of the traditional Chinese medicine disappear or basically disappear, and the syndrome integral is reduced by more than or equal to 95 percent.

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

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

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

Note: the calculation formula (nimodipine method) is: [ (pre-treatment integral-post-treatment integral) ÷ pre-treatment integral ] × 100%.

5.3 determination of curative Effect of the Main indices

According to the clinical research purpose, the main curative effect observation indexes including symptoms, physical signs and laboratory observation indexes are adopted for judging the curative effect.

6 observation of therapeutic effects

6.1 safety observations

1) The physical examination of 300 cases in this group was conducted before and after the treatment, and no obvious abnormality was observed.

2) In 300 cases of the group, no obvious abnormality is found in routine examination of blood, urine, stool, electrocardiogram and renal function before and after treatment.

3) During the verification period, in 2 of 300 cases in the group, stomach pain appears, and 1 case of mild diarrhea, the symptoms disappear after self-relief or corresponding symptomatic treatment. The treatment was not affected.

6.2 Observation of therapeutic Effect

1) Improvement of the outcome after treatment of the major associated symptoms, signs

The group observes and counts the improvement rate of main symptoms and physical signs of 300 cases in different degrees after treatment, the observation time is 8-12 weeks, the percentage of the improvement rate refers to the disease curative effect judgment standard, and the result is shown in table 1.

TABLE 1 number and percentage of cases with improved rates of the chief complaints, signs

2) Physical and chemical inspection

In this group, 300 patients were examined before and after treatment for blood sedimentation (ESR), Rheumatoid Factor (RF), C-reactive protein (CRP), and hand X-ray film. The test results are shown in table 2, the damage degree of the bone structure of the hand X-ray film is staged, and no obvious change is caused before and after treatment.

TABLE 2 ESR and CRP test results before and after treatment (mean and reduction rate)

3) Improved results before and after traditional Chinese medicine syndrome treatment

The group observed and counted 300 cases with different degree of reduction rate of integral value obtained from the syndrome of TCM after treatment. The observation time is 12 weeks, the division of the reduction rate of the integral value refers to the syndrome curative effect standard, and the results are shown in Table 3.

TABLE 3 number and percentage of cases with decreased integral value after treatment of TCM syndrome

4) The clinical changes of main relevant symptoms and signs of 300 cases in the group before treatment all obtain improvement rates of different degrees after treatment. The results of disease efficacy as judged by the improvement rate are shown in table 4:

TABLE 4 determination of the efficacy of the disease

5) The integral values of all the traditional Chinese medicine syndromes of 300 blood stasis obstruction syndromes in the group are reduced to different degrees after treatment, and the results of judging the syndrome curative effect according to the reduction rate of all the integral values are shown in Table 5.

TABLE 5 determination of the efficacy of the Chinese medicine syndrome

6) And (4) checking: the patients in 300 cases of the group are examined before and after treatment by blood sedimentation, rheumatoid factors, C-reactive protein and hand X-ray, the average reduction rate of the blood sedimentation, the rheumatoid factors and the C-reactive protein in 300 cases before and after treatment is 75.6%, 89.9% and 75% in sequence, and the average reduction rate of the blood sedimentation, the rheumatoid factors and the C-reactive protein in 300 cases before and after treatment is not obviously changed by the double-hand X-ray film.

7 results

Through observation, the total effective rate of the composition is 95.6%, and the composition is used for routine examination of blood, urine and feces, electrocardiogram and renal function before and after use, and no obvious abnormality is found, so that the composition is proved to be safe and effective.

Detailed Description

Example 1

The formula is as follows: 104.7g of tripterygium wilfordii, 16.8g of radix rehmanniae recen, 33.6g of rhizoma atractylodis, 33.6g of honeysuckle stem, 33.6g of caltrop, 56g of codonopsis pilosula and 20g of medlar;

the preparation method comprises the following steps: decocting the seven medicines with water twice, the first time lasts for 2 hours, the second time lasts for 1.5 hours, filtering, combining the filtrates, standing and filtering, concentrating the filtrate under reduced pressure until the relative density is 1.02-1.06 (60 ℃), adding 3g of sodium benzoate, stirring, standing for 24 hours, filtering, adding water to adjust the total amount to 1000ml, filtering, subpackaging and sterilizing to obtain the traditional Chinese medicine.

The functions and indications are as follows: to replenish qi, nourish yin, remove toxicity and dredge collaterals. Can be used for treating red swelling and pain of limbs due to deficiency of both qi and yin and obstruction of collaterals by toxic heat, with symptoms of fever, thirst, dysphoria with smothery sensation in chest, short breath, and perspiration, and can be used for treating rheumatoid arthritis with the above symptoms.

Specification: each 1ml contains 0.3g of crude drug.

The application and dosage are as follows: it is administered orally at a dose of 20ml, 3 times a day after meals.

Example 2

The formula is as follows: 98g of tripterygium wilfordii, 20g of radix rehmanniae recen, 45g of rhizoma atractylodis, 25g of honeysuckle stem, 45g of caltrop, 60g of codonopsis pilosula and 14g of wolfberry fruit;

the preparation method comprises the following steps: taking the bulk drugs according to the prescription amount, adding 70 percent ethanol with the amount being 12 times of the bulk drugs, and carrying out reflux extraction for 2 times, wherein each time lasts for 1.5 hours; mixing extractive solutions, filtering, recovering ethanol, and concentrating; drying the concentrated solution under reduced pressure, pulverizing into fine powder, adding conventional adjuvants, and mixing; dry pressing, granulating, and tabletting.

Example 3

The formula is as follows: 110g of tripterygium wilfordii, 12g of radix rehmanniae recen, 45g of rhizoma atractylodis, 25g of honeysuckle stem, 45g of caltrop, 50g of codonopsis pilosula and 22g of wolfberry fruit;

the preparation method comprises the following steps: decocting the bulk drugs according to the prescription amount in water for 2 times, the first time lasts for 2 hours, the second time lasts for 1.5 hours, combining the decoctions, filtering, concentrating the filtrate, adding ethanol into the concentrated solution until the ethanol content is 80%, standing, filtering, recovering ethanol from the filtrate until no ethanol smell exists, concentrating, drying, crushing into fine powder, adding auxiliary materials, and mixing uniformly; dry pressing and granulating to obtain the finished product.

Example 4

The formula is as follows: 90g of tripterygium wilfordii, 25g of radix rehmanniae recen, 20g of rhizoma atractylodis, 50g of honeysuckle stem, 20g of caltrop, 70g of codonopsis pilosula and 15g of wolfberry fruit;

the preparation method comprises the following steps: taking the bulk drugs according to the prescription amount, adding 60% ethanol for ultrasonic extraction, concentrating the extract, adding conventional auxiliary materials, and preparing the drop pills according to the conventional technology of the preparation in the field.

Example 5

The formula is as follows: 120g of tripterygium wilfordii, 10g of radix rehmanniae recen, 50g of rhizoma atractylodis, 20g of honeysuckle stem, 50g of caltrop, 40g of codonopsis pilosula and 24g of wolfberry fruit;

the preparation method comprises the following steps: taking the bulk drugs according to the prescription amount, respectively carrying out reflux extraction by using water in an amount which is 12 times that of the bulk drugs, concentrating the extracting solution, adding conventional auxiliary materials, carrying out dry pressing granulation, and tabletting to obtain the traditional Chinese medicine.

Example 6

The formula is as follows: 160g of tripterygium wilfordii, 8g of radix rehmanniae recen, 60g of rhizoma atractylodis, 15g of honeysuckle stem, 60g of caltrop, 30g of codonopsis pilosula and 23g of wolfberry fruit; the preparation method is the same as example 1.

Example 7

The formula is as follows: 80g of tripterygium wilfordii, 30g of radix rehmanniae recen, 15g of rhizoma atractylodis, 60g of honeysuckle stem, 15g of caltrop, 90g of codonopsis pilosula and 12g of wolfberry fruit; the preparation method is the same as example 2.

Example 8

The formula is as follows: 60g of tripterygium wilfordii, 50g of radix rehmanniae recen, 10g of rhizoma atractylodis, 90g of honeysuckle stem, 10g of caltrop, 120g of codonopsis pilosula and 12g of wolfberry fruit; the preparation method is the same as example 3.

Example 9

The formula is as follows: 200g of tripterygium wilfordii, 5g of radix rehmanniae recen, 90g of rhizoma atractylodis, 10g of honeysuckle stem, 90g of caltrop, 25g of codonopsis pilosula and 30g of wolfberry fruit; the preparation method is the same as example 1.

Example 10

The formula is as follows: 104.7g of tripterygium wilfordii extract, 16.8g of radix rehmanniae extract, 33.6g of rhizoma atractylodis extract, 33.6g of honeysuckle stem extract, 33.6g of tribulus terrestris extract, 56g of codonopsis pilosula extract and 20g of medlar extract;

the extracts are respectively prepared by decocting and extracting the raw material medicines with water. Drying the above extracts under reduced pressure, pulverizing into fine powder, mixing, and making into capsule.

Example 11

The formula is as follows: 98g of tripterygium wilfordii extract, 20g of radix rehmanniae extract, 45g of rhizoma atractylodis extract, 25g of honeysuckle stem extract, 45g of tribulus terrestris extract, 60g of codonopsis pilosula extract and 14g of medlar extract;

Example 12

The formula is as follows: 110g of tripterygium wilfordii extract, 12g of radix rehmanniae extract, 45g of rhizoma atractylodis extract, 25g of honeysuckle stem extract, 45g of tribulus terrestris extract, 50g of codonopsis pilosula extract and 22g of medlar extract;

the extracts are respectively prepared by reflux extraction of each raw material medicine by 60 percent ethanol. Drying the above extracts under reduced pressure, pulverizing into fine powder, mixing, and making into capsule.

Example 13

The formula is as follows: 90g of tripterygium wilfordii extract, 25g of radix rehmanniae extract, 20g of rhizoma atractylodis extract, 50g of honeysuckle stem extract, 20g of tribulus terrestris extract, 70g of codonopsis pilosula extract and 15g of medlar extract;

Example 14

The formula is as follows: 120g of tripterygium wilfordii extract, 10g of radix rehmanniae extract, 50g of rhizoma atractylodis extract, 20g of honeysuckle stem extract, 50g of tribulus terrestris extract, 40g of codonopsis pilosula extract and 24g of medlar extract;

the extracts are respectively prepared by ultrasonic extraction of each raw material medicine through a 70% ethanol solution. Drying the above extracts under reduced pressure, pulverizing into fine powder, tabletting, and making into tablet.

Example 15

The formula is as follows: 160g of tripterygium wilfordii extract, 8g of radix rehmanniae extract, 60g of rhizoma atractylodis extract, 15g of honeysuckle stem extract, 60g of tribulus terrestris extract, 30g of codonopsis pilosula extract and 23g of medlar extract;

Ratio screening experiment

Comparing the therapeutic effects of different proportions of Tripterygium wilfordii and Lycium barbarum (see Table 6) on pain and swelling of rheumatoid arthritis, the dosages of other herbs in the formula are the same as example 1, and oral liquid is prepared according to the method of example 1.

TABLE 6

150 patients clinically diagnosed with rheumatoid arthritis are selected, randomly divided into 5 groups, and 30 patients in each group are respectively taken with the prescription of No. I-V, 10 ml/time, and taken after meals for 3 times a day and two months continuously, and the curative effect is observed.

As a result, the clinical total effective rate of each group is respectively: 40%, 50%, 95%, 90%, 80%; the incidence rate of adverse reactions is respectively as follows: 50%, 40%, 10%, 15%, 60%.

Claims

1. A traditional Chinese medicine composition for treating rheumatoid arthritis is characterized by comprising the following raw material medicines: 104.7 parts of tripterygium wilfordii, 16.8 parts of radix rehmanniae recen, 33.6 parts of rhizoma atractylodis, 33.6 parts of honeysuckle stem, 33.6 parts of caltrop, 56 parts of codonopsis pilosula and 20 parts of medlar.

2. The traditional Chinese medicine composition of claim 1, which is prepared into powder, tablets, capsules, granules, oral liquid or pills according to a conventional preparation process.

3. A traditional Chinese medicine composition for treating rheumatoid arthritis is characterized by comprising the following raw material medicines: 104.7 parts of tripterygium wilfordii extract, 16.8 parts of radix rehmanniae extract, 33.6 parts of rhizoma atractylodis extract, 33.6 parts of honeysuckle stem extract, 33.6 parts of tribulus terrestris extract, 56 parts of codonopsis pilosula extract and 20 parts of medlar extract.

4. The swelling-diminishing and pain-relieving liquid is characterized in that the traditional Chinese medicine raw material medicine of the swelling-diminishing and pain-relieving liquid is the traditional Chinese medicine composition of claim 1 or 3.

5. Use of the Chinese medicinal composition of claim 1 or 3 in the preparation of a medicament for the treatment of rheumatoid arthritis.