CN103721019B - A kind of Chinese medicine composition improving rheumatoid arthritis - Google Patents

Abstract

A kind of Chinese medicine composition improving rheumatoid arthritis, it relates to a kind of Chinese medicine composition.The invention solves the problems that the weak points such as existing drug side effect is big, price is high, the pharmaceutical formulation in existing Chinese medicine is complicated, containing hormone and toxic component, the problem easily causing complication.The Chinese medicine composition of the present invention, is made up of the Radix Glycyrrhizae of the Radix Paeoniae Alba of 35～45 parts, the Ramulus Cinnamomi of 10～20 parts, the Rhizoma Anemarrhenae of 10～20 parts, the Rhizoma Cyperi of 15～25 parts, the Rhizoma Chuanxiong of 10～20 parts, the Eumeces Chinensis of 35～45 parts, the Rhizoma Corydalis of 25～35 parts, the Herba Lycopodii of 15～25 parts, the Herba speranskiae tuberculatae of 15～25 parts, the Herba Pyrolae of 15～25 parts, the Radix Clematidis of 10～20 parts, the Herba Epimedii of 10～20 parts, the Radix Gentianae Macrophyllae of 10～20 parts and 5～15 parts by weight.This Chinese medicine composition flavour of a drug number is few, it is simple to preparation, and abundant raw materials is easy to get, low cost, is suitable to promote, has no side effect, it is easy to accepts.

Description

A kind of Chinese medicine composition improving rheumatoid arthritis

Technical field

The present invention relates to a kind of Chinese medicine composition.

Background technology

Rheumatoid arthritis (rheumatoidarthritis, RA) is cause arthritis and destruction a kind of common Autoimmune disease.This disease sickness rate higher (0.32-0.36%), disability rate is high, has a strong impact on the life quality of patient.Ancestral State's medical science understanding to rheumatoid arthritis, away from the present existing more than 2,000 year history, " Plain Questions. numbness opinion " point out: " wind, cold, wet three gas Miscellaneous extremely, combined into numbness.And arthromyodynia is the general designation of all rheumatismal names of disease of tcm, " Plain Questions. air pocket opinion " meaning " accumulated cold staying in the body, battalion Wei Buju, rolls up meat contracting muscle, and rib elbow must not be stretched, interior for rheumatism involving the bone ".Can regard that, to rheumatoid arthritis ankylosis, sclerotin breaks as Bad description.Doctor carried out useful performance on this basis and supplemented with Zhang Zhongjing for representative later age.< Medical Treasures of the Golden Chamber. in Wind severe and migratory arthralgia abnormal pulse is demonstrate,proved and controls the 5th > middle meaning " suffering from arthritis can not be stretched by song, pain "；" pain in the joints of the extremities, the win of the health rising sun, swelling of the feet is such as De-, vertigo and shortness of breath, temperature temperature tending to vomit, Guizhi-Shoyao-Zhimu Decoction master it.Hereafter order with severe and migratory arthralgia rheumatoid arthritis names of disease of tcm is many Name.

The treatment problem of RA has caused the common concern of clinic.There is the high amount of drug treatment for RA at present, such as non-steroid Body AID, glucocorticoid, antirheumatic and biological preparation etc..But it is permissible still without effective therapeutic scheme Cure RA.Although the associating of many antirheumatics alleviates the state of an illness of RA patient the most to a great extent, but conventional medicament Often with bigger side effect.Currently receive significant attention is the exploitation of biological preparation, wherein applies more generally TNF-α monoclonal antibody.But Ureteral Calculus has been found that TNF-α monoclonal antibody is all responded by not all RA patient Property, even and its ratio reaching clinical remission of patient of responding property only account for 25%-50%；Another drawback of biological preparation It is that medical expense is expensive.So these medicines are to be selected as two, three line medications for a long time.

Along with the RA patient that increases the weight of of the state of an illness often loses ability to act, have a strong impact on quality of life, therefore in RA treatment urgently Treat the reaction that can effectively control inflammation, delay the progress of patient disease, and farthest reduce what drug side effect brought Puzzlement, improves quality of life and the medicine of reasonable price of RA patient.Traditional Chinese medical herbal treatment rheumatoid arthritis is with a long history, by Long in the rheumatoid arthritis course of disease, to fall ill relevant to autoimmune and machine-processed complicated, existing Chinese prescription is the most complicated, very Drug Prepared from Insects containing toxic side effect or hormone composition in many prescriptions.Due to formula is complicated and a lot of formula to contain flesh and blood in love Product, price is relatively costly.

Summary of the invention

It is desirable to provide a kind of Chinese medicine composition improving rheumatoid arthritis, described Chinese medicine composition be for Overcome the weak points such as prior art Chinese medicine side effect is big, price is high, in order to solve the pharmaceutical formulation in existing Chinese medicine Complexity, containing hormone and toxic component, the problem easily causing complication.

A kind of Chinese medicine composition improving rheumatoid arthritis of the present invention, is white by 35～45 parts by weight Chinese herbaceous peony, the Ramulus Cinnamomi of 10～20 parts, the Rhizoma Anemarrhenae of 10～20 parts, the Rhizoma Cyperi of 15～25 parts, the Rhizoma Chuanxiong of 10～20 parts, the mountain of 35～45 parts Dragon, the Rhizoma Corydalis of 25～35 parts, the Herba Lycopodii of 15～25 parts, the Herba speranskiae tuberculatae of 15～25 parts, the Herba Pyrolae of 15～25 parts, 10～20 parts Radix Clematidis, the Herba Epimedii of 10～20 parts, the Radix Gentianae Macrophyllae of 10～20 parts and 5～15 parts Radix Glycyrrhizae composition.

The present invention comprises following beneficial effect:

The Chinese medicine composition zoopery of the present invention shows to reduce the arthritis score of CIA mice, stops pathology Progress；Delay CIA Mouse Weight to decline degree, reduce foot pawl swelling degree；Clinical experiment can reduce pain index, tenderness refers to Number, swelling index and function of joint classification；Shorten deadlock time in morning and 15 meters of walk test times, improve the average grip of both hands and change Kind erythrocyte sedimentation rate and c reactive protein, show that it improves Rheumatoid Arthritis definitely notable, this Chinese medicine composition flavour of a drug number simultaneously Few, it is simple to preparation, abundant raw materials is easy to get, low cost, is suitable to promote, has no side effect, it is easy to be accepted by patients.To suffering from class The patient of rheumatic arthritis treats, and its treatment total effective rate is 90%.

The Chinese medicine composition side of the present invention solves as follows:

The Radix Paeoniae Alba: bitter, acid, be slightly cold, returns liver, spleen channel.Effect: nourish blood yin fluid astringing, easing the affected liver to relieve pain, suppressing liver-YANG, modern pharmacology grinds Studying carefully display, the Main Ingredients and Appearance white peony root's total glycoside that the Radix Paeoniae Alba contains has antiinflammatory and analgesic activity, can treat rat assist agent arthritis, The generation of white peony root's total glycoside regulation IL-1 is probably it and plays immunomodulating and prevent and treat one of arthritic mechanism；White peony root's total glycoside is Clinical practice improves rheumatoid arthritis.

Ramulus Cinnamomi: pungent, sweet, warm, GUIXIN, lung, bladder warp.Effect: relieving the exterior syndrome by diaphoresis, warming the meridian for promoting the flow of YANG QI.Modern pharmacological research shows Ramulus Cinnamomi contains volatile oil 0.2%～0.9%, and in oil, main component is cinnamic aldehyde, and Ramulus Cinnamomi has antiviral, antibacterial, antipyretic-antalgic, profit Urine, antiinflammatory and anti-allergic effects.

The Rhizoma Anemarrhenae: bitter, sweet, cold, returns lung, stomach, kidney channel.Effect: clearing away heat-fire, nourshing Yin and drynsessmoistening prescription.Modern pharmacological research confirms to know Female active ingredient is Sapogenin from Zhimu, zhimusaponin A Yu B, Rhizoma Anemarrhenae flavone and Rhizoma Anemarrhenae sterol, can be with resisting pathogenic microbes, solution Heat, blood sugar lowering, antitumor, suppression platelet aggregation.

Rhizoma Cyperi: pungent, bitter, sweet, flat, returns liver, tri-jiao channel.Effect: resolving depression of regulating the flow of vital energy, menstruction regulating and pain relieving, antiabortive.Modern pharmacological research Show that Rhizoma Cyperi contains glucose, fructose, starch, volatile oil, there is antipyretic-antalgic, cooling, antiinflammatory, antibacterial, suppression prostaglandin Biosynthesiss etc. act on.

Rhizoma Chuanxiong: pungent, warm, returns liver, gallbladder, heart channel.Effect: blood-activating and qi-promoting, wind-expelling pain-stopping.Modern pharmacological research shows Rhizoma Chuanxiong institute It is ligustrazine and ferulic acid etc. containing effective ingredient, there is the effects such as calmness, analgesia, radiation antibacterial, anti-, diuresis.

Eumeces Chinensis: sweet, bitter, warm, returns liver, kidney, lung meridian.Effect: relaxing muscles and tendons to promote blood circulation, relieving cough and resolving phlegm, wind-expelling pain-stopping.Modern pharmacology grinds Study carefully confirmation Eumeces Chinensis and contain dioscin, Barrelierin, fringe Rhizoma Smilacis Chinensis steroid glycoside, 25-D-spiral shell steroid-3,5-diene and to hydroxybenzyl Tartaric acid, has antitussive, eliminates the phlegm, relievings asthma, lowering blood pressure and blood fat, improves the effects such as coronary circulation.

Rhizoma Corydalis: acrid, bitter, warm, GUIXIN, spleen, liver, lung meridian.Effect: blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain.Modern pharmacological research shows Show, Rhizoma Corydalis may separate out 15 kinds of alkaloids, there is analgesic activity, cerebral cortex and infracortical electrical activity, energy can be suppressed Protection rat, because of hungry or produced Experimental Gastric Ucler such as injection cortisone and reserpine etc., reduces gastric secretion, reduces stomach Sour and pepsic amount.

Herba Lycopodii: bitter, pungent, warm, returns Liver Channel.Effect: expelling wind and cold, dehumidifying detumescence, relaxing muscles and tendons and activating QI and blood in the collateral.Modern pharmacological research table Bright Herba Lycopodii active ingredient is complicated, containing multiple alkaloid, have cooling, blood pressure lowering, antibacterial, increase myocardial contraction, excited put down Sliding flesh effect.

Herba speranskiae tuberculatae: pungent, warm, returns Liver Channel.Effect: expelling wind and removing dampness, promoting blood circulation and detumescence pain relieving.Modern pharmacological research confirms Herba speranskiae tuberculatae Chemical composition mainly has alkaloid, organic acid etc., and the analgesia anti rheumatism action of Herba speranskiae tuberculatae water decoction is similar to Salicylates, Within after taking medicine 2～3 hours, playing a role, water decoction external has antiinflammatory, sterilizes, restrains wound surface effect.

Herba Pyrolae: sweet, bitter, warm, returns lung, stomach, liver, kidney channel.Effect: qi-restoratives, kidney tonifying, expelling wind and removing dampness, promoting blood flow to regulate menstruation.Modern Pharmacological research shows that Herba Pyrolae contains N-phenyl-2-naphthylamine, and Chimaphila umbellata is plain, homoarbutin, gallic acid, protocatechuic acid, Pyrolin, Quercetin, gallotannin, renifolin, hyperin, Galla Turcica (Galla Helepensis) acyl hyperin etc..Have antibacterial, The effects such as anti-pregnant, promotion is immune, increase myocardial contraction arrhythmia.

Herba Epimedii: pungent, sweet, warm, returns liver, kidney, warp.Effect: kidney invigorating and YANG supporting, expelling wind and removing dampness.Modern pharmacological research confirms celestial being Spirit spleen mainly containing flavone compound, lignanoid, alkaloid, volatile oil etc., have antitussive, eliminate the phlegm with relieving asthma, antimicrobial, fall Pressure, diuresis, raising sexual excitation etc. act on.

Radix Clematidis: pungent, salty, warm, returns bladder warp.Effect: expelling wind and removing dampness, removing obstruction in the collateral to relieve pain.Modern pharmacological research shows Wheeling Celestial containing Anemonin, anemonol, sterol, saccharide, Saponin, lactone, phenols, aminoacid etc., there is blood pressure lowering, blood sugar lowering, resist The effects such as diuresis, excited smooth muscle, antibacterial and induced labor.

Radix Gentianae Macrophyllae: pungent, bitter, be slightly cold, returns stomach, liver, gallbladder meridian.Effect: rheumatism, relaxing muscles and tendons network, clearind deficient heat.Modern pharmacological research is demonstrate,proved Real Radix Gentianae Macrophyllae is containing erythricine, gentianidine, gentianol and gentiopicrin.There is antiinflammatory, antibacterial, calm, analgesia, blood pressure lowering, liter The pharmacological action such as blood glucose, antagonizing histamine.

Ramulus Cinnamomi, the Radix Paeoniae Alba, the Rhizoma Anemarrhenae have share expelling wind and removing dampness, the effect of the cold expelling that activates yang；Rhizoma Cyperi is gas medicine in blood, and Rhizoma Chuanxiong is in gas Blood medicine, two medicines share promoting the circulation of blood of regulating the flow of vital energy, dispelling wind and removing obstruction in the collateral；Rhizoma Corydalis, Radix Clematidis promoting blood circulation, dredging meridian and relieving pain；The dehumidifying detumescence of Herba Lycopodii, Herba speranskiae tuberculatae； Helping with Medicine for the treatment of rheumatism and arthritis Eumeces Chinensis, Herba Pyrolae, Herba Epimedii, Radix Gentianae Macrophyllae again, play warming YANG of regulating the flow of vital energy, promoting blood circulation to remove obstruction in the collateral, expelling wind and removing dampness altogether, detumescence is only Effect of pain.

Accompanying drawing explanation

Fig. 1 is the arthritis score curve chart in zoopery, and wherein, A is model group arthritis score curve, and B is low Dosage group arthritis score curve, C is middle dosage group arthritis score curve, and D is meloxicam group arthritis score curve, E For high dose group arthritis score curve.

Detailed description of the invention

Detailed description of the invention one: a kind of Chinese medicine composition improving rheumatoid arthritis of present embodiment, by weight Number be the Radix Paeoniae Alba by 35～45 parts, the Ramulus Cinnamomi of 10～20 parts, the Rhizoma Anemarrhenae of 10～20 parts, the Rhizoma Cyperi of 15～25 parts, 10～20 parts Rhizoma Chuanxiong, the Eumeces Chinensis of 35～45 parts, the Rhizoma Corydalis of 25～35 parts, the Herba Lycopodii of 15～25 parts, the Herba speranskiae tuberculatae of 15～25 parts, 15～25 The Radix Glycyrrhizae group of Herba Pyrolae, the Radix Clematidis of 10～20 parts, the Herba Epimedii of 10～20 parts, the Radix Gentianae Macrophyllae of 10～20 parts and 5～15 parts of part Become.

The Chinese medicine composition zoopery of present embodiment can reduce the arthritis score of CIA mice, stops pathology Progress；Delay CIA Mouse Weight to decline degree, reduce foot pawl swelling degree；Clinical experiment can reduce pain index, tenderness refers to Number, swelling index and function of joint classification；Shorten deadlock time in morning and 15 meters of walk test times, improve the average grip of both hands and change Kind erythrocyte sedimentation rate and c reactive protein, show that it improves Rheumatoid Arthritis definitely notable, this Chinese medicine composition flavour of a drug number simultaneously Few, it is simple to preparation, abundant raw materials is easy to get, low cost, is suitable to promote, has no side effect, it is easy to be accepted by patients.

Detailed description of the invention two: present embodiment is unlike detailed description of the invention one: described improvement rheumatoid is closed The Chinese medicine composition that joint is scorching, be by weight the Radix Paeoniae Alba by 40 parts, the Ramulus Cinnamomi of 15 parts, the Rhizoma Anemarrhenae of 15 parts, the Rhizoma Cyperi of 20 parts, The Rhizoma Chuanxiong of 15 parts, the Eumeces Chinensis of 40 parts, the Rhizoma Corydalis of 20 parts, the Herba Lycopodii of 20 parts, the Herba speranskiae tuberculatae of 20 parts, the Herba Pyrolae of 20 parts, 15 parts Radix Clematidis, the Herba Epimedii of 15 parts, the Radix Gentianae Macrophyllae of 15 parts and 10 parts Radix Glycyrrhizae composition.Other is identical with detailed description of the invention one.

Present invention is not limited only to the content of the respective embodiments described above, one of them or the group of several detailed description of the invention Contract sample can also realize the purpose of invention.

By following example checking beneficial effects of the present invention:

1, zoopery

1.1 laboratory animals and reagent

1.1.1 Animals Male DBA/1 mice 8-12 week old 70 (this Leco Corp. of Shanghai)

1.1.2. medicine and reagent: cattle II Collagen Type VI (SIGMA company of the U.S.), (U.S. SIGMA is public for Freund's complete adjuvant Department), lipopolysaccharide (SIGMA company of the U.S.), Chinese medicine suspension (is prepared the Chinese medicine suspension obtained) by embodiment two method, beautiful Luo Xikang (SIGMA company of the U.S.)

1.2 experimental technique

1.2.1 configuration Chinese medicine composition suspension: according to " the new Chinese medicine pharmacological method " of Li Yikui chief editor, conversion Go out the consumption of 20g mice, the maximum tolerated dose drawn according to the result of Drug toxicity trails, determine high, medium and low Three doses, Cross 100 mesh dusting covers after decoction, make suspension.

1.2.2 CIA(Collagen-Induced Arthritis is set up) model: cattle II Collagen Type VI (2mg/ml) is dissolved in 0.05M acetic acid In, vortex, 4 DEG C are the most standby.Immune first day by cattle II Collagen Type VI and Freund's complete adjuvant equal proportion emulsifying.Little to DBA/1 The II Collagen Type VI of rat-tail portion injection cattle and the mixture 0.1ml(of Freund's complete adjuvant are containing 100 μ g cattle II Collagen Type VIs).21st day, DBA/1 mouse peritoneal injection 0.1mlPBS after initial immunity contains 100 μ g cattle II Collagen Type VIs.Immunity the 28th day, does not has joint The CIA mouse peritoneal of inflammation shape injects 40 μ g lipopolysaccharide.

1.2.3 Chinese medicine suspension immunologic intervention CIA mice: immunity the 21st day, the CIA mice without arthritic symptom is divided at random Become five groups, respectively model group, low dose group (10g/kg/d), middle dosage group (15g/kg/d), high dose group (20g/kg/d), Meloxicam group (50mg/kg/d), Chinese medicine suspension and control drug gastric infusion, be used in conjunction 30 days.

1.2.4 general state is observed: observe the mental status of mice, feed, body weight, hair, liveness.

1.2.5 arthritic symptom scoring: from immunity the 21st day, carrying out an arthritis score in every two days, standards of grading are such as Under: 0: be not changed in, 0.25: one to two toe is red or swollen；0.5: three to five toe is red or swollen；Ankle swelling；Sole swelling； Serious swelling and joint deformity, scoring uses double-blind method.

1.2.6 toes swelling level determinations: from immunity the 38th, every 6 days, with slide gauge, rear solid end swelling degree is entered Row measures, and surveys 3 times continuously.

1.2.7 histopathology progress: treat latter 30 days and put to death some animals, separate knee joint, fixing, paraffin embedding, Section, histological stain, synovial membrane inflammation degree (0-3 level) and cartilage destruction degree (0-4 level) and bone are infiltrated and is estimated, Evaluate the histopathology progress of each group of mice.

1.2.8 statistical analysis experimental data uses SPSS17.0 software to carry out statistical procedures.Analysis result withCome Representing, the comparison of many group sample averages uses one factor analysis of variance, and group difference uses SNK inspection.It is poor that P < 0.05 is defined as Different statistically significant.

1.3 experimental result

1.3.1 the Chinese medicine suspension impact on CIA Mouse Weight

At latter 30 days of immunity, model group, low dose group, middle dosage group, high dose group, meloxicam group, CIA Mouse Weight It is showed no growth, presents downward trend on the contrary, but high dose group weight loss amplitude is little, model group 15.93 ± 4.57(g) with high Dosage group 19.01 ± 5.22(g) compare significant difference (P < 0.05).

1.3.2 arthritis score

Immunity rises for 21 days, within every two days, carries out an arthritis score, until the 51st day, compared with model group, high dose shows Writing and reduce the scoring of CIA mouse arthritis, each group arthritis score is shown in Fig. 1.

1.3.3 toes swelling is measured

Immunity the 50th day model group left back pawl 3.024 ± 0.67(mm) with high dose group 2.227 ± 0.803(mm) compared with have Significant difference (P < 0.05).

1.3.4 joint tissue pathology

After treatment the 30th day, high dose group can stop cartilage destruction and bone infiltration compared with model group.It is shown in Table 1.

Table 1CIA mice knee joint cytological stains is marked

Packet

Cell infiltration

Cartilage destruction

Bone infiltrates

Model group	1.19±0.4	1.12±0.3	1.97±0.7
				Meloxicam group	0.9±0.5	0.8±0.3	1.7±0.6
High dose group	0.89±0.4	0.21±0.3*	0.67±0.4*
				Middle dosage group	0.98±0.5	0.89±0.3	1.7±0.6
Low dose group	1.15±0.5	0.98±0.4	1.7±0.5

Note: compared with model group^*P<0.05。

1.4 pharmacological toxicology detection tests

1.4.1 pharmacology test

1.4.1.1 experimental condition: select ICR mice, fill with tri-dosages of 15g/kg, 30g/kg and 60g/kg respectively Stomach gives Chinese medicine suspension (preparing the Chinese medicine suspension obtained by embodiment two method).

1.4.2.2 result of the test: observe the Chinese medicine suspension shadow at different dosages to animal subject central nervous system Ring: 1) the mice activity of each administration group more freely, gait, posture are normal；Without sialorrhea, amyostasia, benumb, twitch, movement disorder, no Peace, run shout, irritation or perpendicular hair of crispaturaing, Novel presentation in terms of the nervous system such as insensitive；2) have no mice Central nervous system significantly affects, and nor affects on the body coordination exercise function of animal subject；3) to mice pentobarbital sodium The experiment of threshold dose and sub-threshold dose impact does not finds there is synergism between medicine and central inhibitor pentobarbital sodium.

1.4.2 safety analysis and evaluation

1.4.2.1 experimental condition: select ICR mice, respectively with 15g/kg, 30g/kg, 60g/kg and 70g/kg to medicament Amount, uses gavage to give Chinese medicine suspension (preparing the Chinese medicine suspension obtained by embodiment two method), wherein, maximum administration Amount Chinese medicine suspension is 70g/kg body weight (for 3.5 times of clinical plan dosage), one day gastric infusion 1 time.

1.4.2.2 result of the test: under this dosage except be administered the same day, have no that overt toxicity reacts, in 14 days animal none Death, gross anatomy also has no that the toxicity to internal organs changes.

1.4.3 long term toxicity test

1.4.3.1 experimental condition: by body weight dose,equivalent conversion three dosage groups of design: select SD rat, by institute Respectively with 60,40,30g/kg/d(be equivalent to clinical the 5 of plan daily dose, 3.3,2.5 times), every day gastric infusion 1 time, weekly It is administered 7 days, successive administration 4 weeks.

1.4.3.2 result of the test: each treated animal is movable normal, hair color is smooth, and all signs compare with matched group and have no poor Not and abnormal change, food ration, body weight, hematology and blood biochemical analysis index, organ-tissue, organ weights and organ coefficient are equal Without substantially changing, convalescent period also without retardance toxic reaction, without retardance pathological change.

Illustrate that this medicine is equivalent to clinical plan daily dose 5 times at 60g/kg/d() under dosage, for nontoxic crude protein, show This medicine has bigger safe space, is safely and effectively under the using dosage recommended.

2, clinical experiment

2.1 case sources

All cases was gone to a doctor in Second Affiliated Hospital of Harbin Medical Univ.'s rheumatism in December, 2008 selected from January, 2008 The patient of section's outpatient service, wherein male 27 example, women 73 example, in age 22-65 year, 43.5 ± 21.5 years old mean age, the course of disease is the shortest Person six months, elder 20 years；123 ± 117 months.

2.2 diagnostic criteria

Continuing to use the criteria for classification of Americanism damp disease association revision in 1987, specific standards is as follows:

2.2.1 intraarticular or surrounding are refused to budge continuous at least 1 hour morning；

The most at least while there are 3 hinge area soft tissues swollen or hydrops；

2.2.3 wrist, the palm refer to, in proximal interphalangeal joint district, at least 1 hinge area swelling；

2.2.4 symmetry arthritis；

2.2.5 there is rheumatoid nodules；

2.2.6 serum RF positive (positive less than 5% in method therefor normal population)；

2.2.7X line sheet changes (at least osteoporosis and joint space are narrow).

Meet in above 7 that 4 persons are diagnosable at least continues 6 weeks for first to fourth course of disease of RA()

2.3 case inclusive criterias

All meet Western medicine diagnose standard person, include experiment case in.

2.4 case exclusion standards

Though being 2.4.1 primary disease but long-term taking Western medicine or other drug person, it is necessary to disable and the most preferably get rid of.

2.4.2 severe primary disease, the psychotics such as cardiovascular, liver, kidney and hemopoietic system are merged.

2.4.318 below year, over-65s patient, gravid woman, those who are allergic to this drug.

2.4.4 late deformity, maimed, disability person, the most preferably gets rid of

2.4.5 inclusive criteria is not met, not by regulation medication, it is impossible to judge curative effect or the congruent safety that affects the treatment of data Property judgement person.

2.5 Therapeutic Method

The Chinese medicine composition obtained by the proportioning of detailed description of the invention two is decocted in water for oral dose, day potion, every day is sooner or later point Clothes.It it was a course for the treatment of with 30 days.Observe first 2 weeks rise and take other Chinese and western drugses or use other treatment method.Before and after treatment Checking, primary part observation project has deadlock in morning, arthralgia index, tenderness index, swelling index, joint function disturbance to refer to comprehensively Number, the average grip of both hands, 15 meters of walking times.Lab testing erythrocyte sedimentation rate (ESR), rheumatoid factor (RF), c reactive protein, choosing Select bat arthroncus X-ray film.

2.6 efficacy assessment standard

Therapeutic evaluation is carried out after terminating the course for the treatment of.Articular pain index, arthralgia index, joint swelling index are divided into 3 grades； Function of joint is classified as I, II, III, IV grade.The deadlock time in morning calculates with minute (min), and the average grip of both hands calculates with mmHG, and 15 The rice walking time calculated with the second (s).

Criterion of therapeutical effect is formulated with reference to " new Chinese medicine guideline of clinical investigations ".Effective: cardinal symptom, sign entirety are improved Rate >=75%.Erythrocyte sedimentation rate and C reactive protein normally or are obviously improved or close to normal.Progressive: cardinal symptom, sign entirety improvement rate ≥50%.Erythrocyte sedimentation rate and C reactive protein have improvement.Effective: cardinal symptom, sign entirety improvement rate >=30%.Erythrocyte sedimentation rate and C-react egg There is improvement in vain or without improving.Invalid: cardinal symptom, sign entirety improvement rate < 30%.Erythrocyte sedimentation rate and C reactive protein are without improving.

2.7 experimental result

It is 2.7.1 the most statistically significant compared with after treatment before arthralgia index, tenderness index, the treatment of swelling index, Testing result is shown in Table 2.

Compare before and after the treatment of table 2 pain index, tenderness index, swelling index

Observe index	n	Integration before treatment	Integration after treatment
				Pain index	100	12.35±2.94	5.37±2.16*
Tenderness index	100	6.35±0.87	1.46±0.23*
				Swollen index is swollen	100	3.97±0.27	1.29±0.30*

Note: * P < 0.05 compared with before treatment.

2.7.2 before deadlock in morning time, function of joint classification, the average grip of both hands, the treatment of 15 meters of walking times with treat after phase Ratio is the most statistically significant, and testing result is shown in Table 3.

Compare before and after table 3 deadlock in morning time, function of joint classification, the average grip of both hands, 15 meters of walking time treatments

Observation index	n	Before treatment	After treatment
				The deadlock time in morning (min)	100	121.7±20.35	55.66±19.93*
Functional classification	100	1.91±0.345	1.37±0.28*
				Grip (mmHg)	100	101.44±16.22	114.25±13.36*
15 meters of travel times (s)	100	27.05±3.67	15.21±2.34*

Note: compared with before treatment^*P<0.05。

2.7.3 before and after treatment, erythrocyte sedimentation rate (ESR), C reactive protein (CRP) are compared statistically significant, rheumatoid factor (RF) The front not statistically significant compared with after treatment for the treatment of, the change of major laboratories index is shown in Table 4.

The comparison of ESR, RF and CRP before and after table 4 treatment

Lab index	n	Before treatment	After treatment
				ESR	100	56.53±7.77	35.19±8.85*
CRP	100	17.56±4.38	7.04±2.23*

RF

100

35.11±9.37

31.25±5.19

Note: compared with before treatment^*P<0.05。

2.7.4 comprehensive therapeutic effect analysis, this organizes 100 examples, effective 65 examples after treatment, progressive 15 examples, effective 10 examples, and invalid 10 Example, total effective rate 90%.

Claims (1)

1. the Chinese medicine composition improving rheumatoid arthritis, it is characterised in that it is white by 40 parts by weight Chinese herbaceous peony, the Ramulus Cinnamomi of 15 parts, the Rhizoma Anemarrhenae of 15 parts, the Rhizoma Cyperi of 20 parts, the Rhizoma Chuanxiong of 15 parts, the Eumeces Chinensis of 40 parts, the Rhizoma Corydalis of 20 parts, 20 parts stretch Muscle grass, the Herba speranskiae tuberculatae of 20 parts, the Herba Pyrolae of 20 parts, the Radix Clematidis of 15 parts, the Herba Epimedii of 15 parts, the Radix Gentianae Macrophyllae of 15 parts and 10 parts sweet Grass is made.