CN103405582B

CN103405582B - Traditional Chinese medicine composition for improving joint gall of rheumatoid arthritis

Info

Publication number: CN103405582B
Application number: CN201310340795.6A
Authority: CN
Inventors: 李拥军
Original assignee: LIUZHOU HOSPITAL OF TRADITIONAL CHINESE MEDICINE
Current assignee: LIUZHOU HOSPITAL OF TRADITIONAL CHINESE MEDICINE
Priority date: 2013-08-07
Filing date: 2013-08-07
Publication date: 2015-01-28
Anticipated expiration: 2033-08-07
Also published as: CN103405582A

Abstract

The invention relates to a traditional Chinese medicine composition for improving joint gall of rheumatoid arthritis and a preparation method thereof. The traditional Chinese medicine comprises the following raw materials: shinyleaf pricklyash root, kadsura longepedunculata, cortex acanthopanacis, tinospora sinensis merr, clematis chinensis, cissus pteroclada hayata, sargentodoxa cuneata and Chinese starjasmine stem, and is applied to joint gall caused by wind, cold, wet, phlegm and blood stasis obstruction of meridians and collaterals. The effective constituents of the traditional Chinese medicine composition provided by the invention are the following raw materials: shinyleaf pricklyash root, kadsura longepedunculata, cortex acanthopanacis, tinospora sinensis merr, clematis chinensis, cissus pteroclada hayata, sargentodoxa cuneata and Chinese starjasmine stem. The traditional Chinese medicine composition has a remarkable curative effect on the aspect of improving joint gall of the rheumatoid arthritis, and the effect is superior to that of the prior art.

Description

Improve the Chinese medicine composition of rheumatoid arthritis arthralgia

Technical field

The present invention relates to the field of Chinese medicines, be specifically related to a kind ofly improve Chinese medicine composition of rheumatoid arthritis arthralgia and preparation method thereof.

Background technology

The systemic autoimmune diseases of rheumatoid arthritis (rheumatoid arthritis, RA) to be a kind of with erosive arthritis be main manifestations.Primary disease is multiple with women.The ill ratio of men and women is about 1:3.RA can betide any age, with 30 ~ 50 years old for morbidity peak.The RA prevalence in China mainland area is about 0.2%-0.4%.Primary disease shows as symmetry, the persistence polyarthritis of getting involved based on the Minor articulus such as both hands and carpal joint.Pathological manifestations is chronic inflammatory disease, the pannus formation of synovium of joint, and occurs cartilage and the osteoclasia in joint, finally can cause joint deformity and afunction.If without regular treatment, there is maimed person in the patient of about 75% in 3 years.

The object for the treatment of rheumatoid arthritis is symptom management, improves function of joint and prognosis.

The treatment of current rheumatoid arthritis, still based on traditional NSAID (non-steroidal anti-inflammatory drug) with improve state of an illness antirheumatic, uses low dose of glucocorticoid to intractable rheumatoid arthritis.Entering 21 century is arisen at the historic moment by the magnetic target therapy of the biological preparation that biology, genetic engineering was produced, the biological preparation can treating RA mainly comprises tumor necrosis factor (TNF)-alpha-2 antagonists, interleukin (IL)-l and IL-6 antagonist, IDEC-C2B8 and T cell costimulatory signal inhibitor etc., but due to its somewhat expensive, clinical practice is restricted.In addition still there are immunologic purging, stem cell transplantation and T cell vaccine effectively, but small number of patients may be only applicable to the alleviation of RA, still need further clinical observation.

In clinical application, for the treatment of rheumatoid arthritis, although use NSAID (non-steroidal anti-inflammatory drug) and improve state of an illness antirheumatic, the state of an illness improves, but still the symptom swollen and ache repeatedly in legacy part joint, for a long time can not complete incidence graph, and there is the untoward reaction such as gastrointestinal reaction, hepatic and renal function injure in the process of Long-term taking medicine.How to alleviate rheumatoid arthritis patients arthralgia repeatedly, reduce the goal in research that drug side effect becomes us.

Because the untoward reaction of western medical treatment is more, more patient is partial to and uses Chinese traditional treatment rheumatoid arthritis.Chinese patent CN201210186089.6 " a kind of Chinese medicinal ointment for the treatment of rheumatic arthritis " discloses the formula of use 15 taste medical material composition, and CN200510045203.3 " a kind of capsule for unblocking collaterals to treat arthritis " employs the formula of 25 taste medicine composition treatment rheumatic arthritis.These prescriptions use flavour of a drug more, and have rare medicinal herbs, and patient's long-term taking medical expense is very large." the routine observation of curative effect of Aconitum carmichjaelii Debx. Tonga taste treatment rheumatoid arthritis 35 " (being published in " the Sichuan traditional Chinese medical science " the 24th volume the 1st phase in 2006), disclose by taking the case observation adding taste Aconiti Decoction treatment rheumatoid arthritis." the medication Frequence Analysis of compound of Chinese medicine zoopery rheumatoid arthritis " (being published in volume the 3rd phase in " Hunan University of Traditional Chinese Medicine's journal " March the 30th in 2010), gathered by the classification of the Chinese medicine compound to 74 treatment rheumatoid arthritis, find that the curative effect of Chinese medicine in treating rheumatoid arthritis is more and more affirmed than doctor trained in Western medicine, in all kinds of pattern of syndrome, the more medicine of medicine frequency used is very close.With in 74 groups of compound recipes, be in the great majority from plan side.Because though actual clinical case has intermingling cold and heat, still based on partially cold or partial heat, there is very large uncertainty from the method for the treatment of choosing side of plan side, may lack repeatability in great majority.In the rheumatoid arthritis Chinese prescription used at present, be mostly furnished with the flavour of a drug with mild toxicity or toxicity, long-term taking orally easily causes toxicity to accumulate, and injures interior internal organs, if use medicated wine to be coated with outward, then easily volatilize, curative effect is not lasting.

Summary of the invention

The object of this invention is to provide a kind of Chinese medicine composition improving rheumatoid arthritis arthralgia;

Another object of the present invention is to provide a kind of Chinese medicine composition preparation method improving rheumatoid arthritis arthralgia.

The object of the invention is by following technical scheme realize:

The Chinese medicine composition of the improvement rheumatoid arthritis arthralgia described in patent of the present invention, it is prepared from by the raw material comprising following weight portion:

Radix Zanthoxyli 70-30 parts, Fructus Schisandrae Sphenantherae 70-30 parts, Cortex Acanthopancis 50-10 parts, Herba Lycopodii 50-10 parts, Radix Clematidis 50-10 parts, Cissus pteroclada Hayata 50-10 parts, Caulis Sargentodoxae 50-10 parts, Caulis Trachelospermi 50-10 parts;

Preferably, be prepared from by the raw material comprising following weight portion:

Radix Zanthoxyli 60-40 parts, Fructus Schisandrae Sphenantherae 60-40 parts, Cortex Acanthopancis 40-20 parts, Herba Lycopodii 40-20 parts, Radix Clematidis 40-20 parts, Cissus pteroclada Hayata 40-20 parts, Caulis Sargentodoxae 40-20 parts, Caulis Trachelospermi 40-20 parts;

More preferably, be prepared from by the raw material comprising following weight portion:

Radix Zanthoxyli 50 parts, Fructus Schisandrae Sphenantherae 50 parts, Cortex Acanthopancis 30 parts, Herba Lycopodii 30 parts, Radix Clematidis 30 parts, Cissus pteroclada Hayata 30 parts, Caulis Sargentodoxae 30 parts, Caulis Trachelospermi 30 parts.

Below the crude drug source of Chinese medicine preparation of the present invention:

Radix Zanthoxyli is rutaceae Radix Zanthoxyli Zanthoxylum nitidum(Roxb.) dry root of DC..Record in " Chinese Pharmacopoeia " version in 2010 the 157th page.

Fructus Schisandrae Sphenantherae is the dry mature fruit of Magnoliacea plant schisandra chinensis Schisandra sphenanthera Rehd. Et Wils..Record in " Chinese Pharmacopoeia " version in 2010 the 227th page.

Cortex Acanthopancis is the dry root bark of Araliaceae acanthopanax gracilistylus Acanthopanax gracilistylus W. W. Smith.Record in " Chinese Pharmacopoeia " version in 2010 the 61st page.

Herba Lycopodii is that Menispermaceae Tinospora plant Tinospora sinensis Tinospora sinensis (Lour.) Merr. has rattan.Record in " the Sanitation Ministry medicine standard Tibetan medicine " first the 87th page.

Radix Clematidis is the dry root and rhizome of ranunculaceae plant Radix Clematidis Clematis chinensis Osbeck, Clematis hexapetala Clematis hexapetala Pall. or northeast clematis Clematis manshurica Rupr..Record in " Chinese Pharmacopoeia " version in 2010 the 234th page.

Cissus pteroclada Hayata is the stem of dicotyledon medicine vitaceae Cissus pteroclada Hayata.Record in " Chinese Pharmacopoeia " version in 1977 the 158th page.

Caulis Sargentodoxae is the dry rattan of plants of Lardizabalaceae Caulis Sargentodoxae Sargentodoxa cuneata (Oliv.) Rehd. et wils..Record in " Chinese Pharmacopoeia " version in 2010 the 19th page.

Caulis Trachelospermi is the dry zone leaf rattan of apocynaceae plant trachelospermum jasminoide Trachelospermum jasminoides (Lindl.) Lem..Record in " Chinese Pharmacopoeia " version in 2010 the 252nd page.

Another aspect of the present invention there is provided the preparation method of the active component of Chinese medicine composition of the present invention, and its preparation method is as follows:

Scheme one: get whole 8 taste medical materials, Soakage extraction 3-4 time, adds medical material gross weight 2-4 50-90% alcohol dipping 12-60 hour doubly at every turn, incline and get supernatant, squeezing medicinal residues, merge three supernatant and pressed liquor, filter, be concentrated into and be equivalent to medical material gross weight 4 ~ 6 times, obtain active component.

Scheme two: get whole 8 taste medical materials, extracting in water 2-3 time, each amount of water is equivalent to the 6-12 of medical material gross weight doubly, each extraction time is 1-3 hour, merge three extracting solution, filter, it is the extractum of 1.10-1.30 that filtrate is concentrated into relative density at 80 DEG C, add ethanol, make alcohol content be 40-70%, leave standstill 12-24 hour, filter, when filtrate is concentrated into 80 DEG C, relative density is the extractum of 1.10-1.25, obtains active component.

Scheme three: get whole 8 taste medical materials, with 40-80% alcohol reflux 2-3 time, each ethanol consumption be the 4-10 of medical material total amount doubly, extraction time is 1-4 hour, merge extractive liquid, filters, when filtrate is concentrated into 60-80 DEG C, relative density is the extractum of 1.10-1.25, obtains active component.

Scheme four: get whole 8 taste medical materials, add be equivalent to this 8 taste medical material gross weight 1 ~ 2 times 40% ~ 60% alcohol dipping 12 ~ 48 hours, then percolation is carried out with the ethanol of 40% ~ 60% with the speed accounting for raw material gross weight 0.2% ~ 0.6% per minute, collect the percolate being equivalent to this 8 taste medical material gross weight 5-10 times amount, reclaim ethanol, be evaporated to 1 ~ 2 times that is equivalent to 8 taste medical material gross weights, filter, obtain medicinal liquid A; Medicinal liquid A is active component.

Scheme five: get whole 8 taste medical materials, add the alcohol dipping 24 ~ 36 hours that the volume by volume concentration being equivalent to this 8 taste medical material gross weight 1 ~ 2 times is 50% ~ 56%, then with volume by volume concentration be 50% ~ 56% ethanol carry out percolation with the speed accounting for raw material gross weight 0.3% ~ 0.5% per minute, collect the percolate being equivalent to this 8 taste medical material gross weight 5-10 times amount, reclaim ethanol, be evaporated to 1 ~ 2 times that is equivalent to 8 taste medical material gross weights, filter, obtain medicinal liquid A; Medicinal liquid A is active component.

The Chinese medicine composition improving rheumatoid arthritis arthralgia of the present invention, with pharmaceutically acceptable carrier combination, can make various common dosage forms.

Such as, it can be prepared as various common exterior-applied formulation by one of following method:

Method 1: tincture

Get the 8 taste medical materials such as Radix Zanthoxyli, Fructus Schisandrae Sphenantherae, Cortex Acanthopancis, Herba Lycopodii, Radix Clematidis, Cissus pteroclada Hayata, Caulis Sargentodoxae, Caulis Trachelospermi, Soakage extraction 3-4 time, add medical material gross weight 2-4 50-90% alcohol dipping 12-60 hour doubly at every turn, incline and get supernatant, squeezing medicinal residues, merge three supernatant and pressed liquor, filter, be concentrated into and be equivalent to medical material gross weight 4 ~ 6 times, filter, subpackage, sealing, obtain the tincture of Chinese medicine composition of the present invention.

Method 2: ointment

Get Radix Zanthoxyli, Fructus Schisandrae Sphenantherae, Cortex Acanthopancis, Herba Lycopodii, Radix Clematidis, Cissus pteroclada Hayata, Caulis Sargentodoxae, Caulis Trachelospermi etc. 8 taste medical material, extracting in water 2-3 time, each amount of water is equivalent to the 6-12 of medical material gross weight doubly, each extraction time is 1-3 hour, merge three extracting solution, filter, it is the extractum of 1.10-1.30 that filtrate is concentrated into relative density at 80 DEG C, add ethanol, alcohol content is made to be 40-70%, leave standstill 12-24 hour, filter, when filtrate is concentrated into 80 DEG C, relative density is the extractum of 1.10-1.25, dry, pulverize, coordinate with appropriate water-soluble base, stir, obtain the ointment of Chinese medicine composition of the present invention.

Method 3: gel rubber plaster unguentum

Get the 8 taste medical materials such as Radix Zanthoxyli, Fructus Schisandrae Sphenantherae, Cortex Acanthopancis, Herba Lycopodii, Radix Clematidis, Cissus pteroclada Hayata, Caulis Sargentodoxae, Caulis Trachelospermi, with 40-80% alcohol reflux 2-3 time, each ethanol consumption is 4-10 times of medical material total amount, extraction time is 1-4 hour, merge extractive liquid, filter, when filtrate is concentrated into 60-80 DEG C, relative density is the extractum of 1.10-1.25; After extractum and appropriate hydrophilic matrix being mixed, be coated with cream lid lining, section, obtains the gel rubber plaster unguentum of Chinese medicine composition of the present invention.

Method 4: lotion

Get the 8 taste medical materials such as Radix Zanthoxyli, Fructus Schisandrae Sphenantherae, Cortex Acanthopancis, Herba Lycopodii, Radix Clematidis, Cissus pteroclada Hayata, Caulis Sargentodoxae, Caulis Trachelospermi, add be equivalent to this 8 taste medical material gross weight 1 ~ 2 times 40% ~ 60% alcohol dipping 12 ~ 48 hours, then percolation is carried out with the ethanol of 40% ~ 60% with the speed accounting for raw material gross weight 0.2% ~ 0.6% per minute, collect the percolate being equivalent to this 8 taste medical material gross weight 5-10 times amount, reclaim ethanol, be evaporated to 1 ~ 2 times that is equivalent to 8 taste medical material gross weights, filter, obtain medicinal liquid A, medicinal liquid A is active component; In active component, add glycerol, make the lotion of Chinese medicine composition of the present invention.

Method 5: powder

Get the 8 taste medical materials such as Radix Zanthoxyli, Fructus Schisandrae Sphenantherae, Cortex Acanthopancis, Herba Lycopodii, Radix Clematidis, Cissus pteroclada Hayata, Caulis Sargentodoxae, Caulis Trachelospermi, extracting in water 2-3 time, each amount of water is equivalent to the 8-12 of medical material gross weight doubly, each extraction time is 1-3 hour, merge extractive liquid, filters, concentrated, adding ethanol makes alcohol content be 50-70%, leave standstill 12-48 hour, elimination precipitate, dry, pulverize, obtain the powder of Chinese medicine composition of the present invention.

Rheumatoid arthritis belongs to motherland's medical science " Bi condition " category, and ancient medicine thinks that the damp and hot heresy of wind and cold is the exopathogenic factor that rheumatoid arthritis occurs more, and insufficiency of vital energy and blood, battalion defend the important endogenous cause of ill that imbalance is primary disease.The Guangxi Yao nationality people due to residence place be remote, thickly forested mountains, height above sea level, very cold is moist, and rheumatic arthralgia is frequently-occurring disease, endemic diseases, and precious jade doctor is referred to as " wind enemy is sick " (precious jade name: buermgh kiex mun), to the treatment of this kind of disease, the various informative external therapy of precious jade medical conclusion, abundant in content, determined curative effect, use directly, often can play the effect of getting instant result.

Multiple formulations, on the basis of research tradition Chinese herbal medicine, through test for many years, from the precious jade medicine proved recipe spread, is screened, be have found the good several drugs of primary disease therapeutic effect and complete the present invention by the applicant.

Chinese medicine composition effective ingredient disclosed in this invention is prepared from by raw materials such as Radix Zanthoxyli, Fructus Schisandrae Sphenantherae, Cortex Acanthopancis, Herba Lycopodii, Radix Clematidis, Cissus pteroclada Hayata, Caulis Sargentodoxae, Caulis Trachelospermis.What in side, Radix Zanthoxyli belonged to precious jade medicine " five tiger " enters mountain tiger, removing toxic substances dehumidifying of dispeling the wind, promoting blood circulation and detumescence pain relieving; Herba Lycopodii, Radix Clematidis belong to the inner operculina turpethum of precious jade medicine " nine Ns ", black nine Ns open close saturating key, expelling wind and removing dampness, soothing the channels and quicking the network vessels function; Caulis Sargentodoxae, Cissus pteroclada Hayata, Fructus Schisandrae Sphenantherae belong to that the inner Semen Arecae of precious jade medicine " 18 bore " bores, four drills with ferrule and bradawl have and pass away arteries and veins, the merit of expelling wind and activating blood circulation, promoting the circulation of QI to relieve pain; Caulis Trachelospermi then belongs to " 72 wind ", and inner wall wind of climbing has expelling wind and removing dampness, dredge the meridian passage, the effect of eliminating stasis to stop pain; Cortex Acanthopancis, precious jade name bar clamping, has liver and kidney tonifying, reducing swelling and alleviating pain.Expelling wind and removing dampness is played, promoting blood circulation to remove obstruction in the collateral, the merit of reducing swelling and alleviating pain altogether in top.Chinese medicine composition of the present invention is to because wind, cold, wet, expectorant are turbid, Yu Xue Bi resistance meridians, the joint caused significant curative effect that swollen and ache, rheumatoid arthritis patients arthralgia can be alleviated rapidly, reduce endo-medicine consumption, avoid the untoward reaction such as gastrointestinal reaction, hepatic and renal function injure.

Chinese medicine composition of the present invention can also use conventional method, makes Emulsion, patch, varnish, spray, liniment etc.

A kind of Chinese medicine composition improving rheumatoid arthritis arthralgia provided by the invention has the following advantages:

1, the present invention is to because wind, cold, wet, expectorant are turbid, Yu Xue Bi resistance meridians, and joint caused inflammation and arthralgia have significant curative effect, also has same significant curative effect to old trouble for many years.

2, use chemical drugs to fail to respond to any medical treatment or curative effect remarkable, symptom does not disappear or disappears after incomplete rheumatoid arthritis arthralgia patient uses the present invention to treat, can arthralgia rapidly, alleviates the misery of patient.

3, external preparation of the present invention can alleviate rapidly rheumatoid arthritis patients arthralgia, reduces endo-medicine consumption, avoids gastrointestinal reaction to reduce drug effect, and causes the untoward reaction such as hepatic and renal function injure.

Detailed description of the invention

The present invention is further illustrated below by embodiment.It should be understood that embodiments of the invention are for illustration of the present invention instead of limitation of the present invention.Essence according to the present invention all belongs to the scope of protection of present invention to the simple modifications that the present invention carries out.Except as otherwise noted, the percent of the amount of alcohol in the present invention is percentage by volume, and v/v represents the volume ratio of solution.

embodiment 1: the preparation of tincture

Get Radix Zanthoxyli 50g, Fructus Schisandrae Sphenantherae 50g, Cortex Acanthopancis 30g, Herba Lycopodii 30g, Radix Clematidis 30g, Cissus pteroclada Hayata 30g, Caulis Sargentodoxae 30g, Caulis Trachelospermi 30g, clean, break into coarse powder, add 80% alcohol dipping 48 hours of medical material gross weight 2 times, incline and get supernatant, add 75% alcohol dipping 48 hours of medical material gross weight 2 times again, incline and get supernatant, add 70% alcohol dipping 24 hours of medical material gross weight 2 times again, incline and get supernatant, squeezing medicinal residues, merge three supernatant and pressed liquor, filter, be concentrated into and be equivalent to medical material gross weight 6 times, filter, subpackage, sealing, obtain.

embodiment 2: the preparation of tincture

Get Radix Zanthoxyli 40g, Fructus Schisandrae Sphenantherae 60g, Cortex Acanthopancis 20g, Herba Lycopodii 40g, Radix Clematidis 40g, Cissus pteroclada Hayata 40g, Caulis Sargentodoxae 10g, Caulis Trachelospermi 30g, clean, break into coarse powder, add 90% alcohol dipping 60 hours of medical material gross weight 4 times, incline and get supernatant, add 70% alcohol dipping 48 hours of medical material gross weight 3 times again, incline and get supernatant, add 50% alcohol dipping 12 hours of medical material gross weight 2 times again, incline and get supernatant, squeezing medicinal residues, merge three supernatant and pressed liquor, filter, be concentrated into and be equivalent to medical material gross weight 4 times, filter, subpackage, sealing, obtain.

embodiment 3: the preparation of tincture

Get Radix Zanthoxyli 30g, Fructus Schisandrae Sphenantherae 60g, Cortex Acanthopancis 40g, Herba Lycopodii 40g, Radix Clematidis 20g, Cissus pteroclada Hayata 30g, Caulis Sargentodoxae 30g, Caulis Trachelospermi 20g, clean, break into coarse powder, add 90% alcohol dipping 54 hours of medical material gross weight 4 times, incline and get supernatant, add 75% alcohol dipping 36 hours of medical material gross weight 3 times again, incline and get supernatant, add 60% alcohol dipping 12 hours of medical material gross weight 2 times again, incline and get supernatant, squeezing medicinal residues, merge three supernatant and pressed liquor, filter, be concentrated into and be equivalent to medical material gross weight 5 times, filter, subpackage, sealing, obtain.

embodiment 4: the preparation of ointment

Get Radix Zanthoxyli 60g, Fructus Schisandrae Sphenantherae 40g, Cortex Acanthopancis 40g, Herba Lycopodii 20g, Radix Clematidis 40g, Cissus pteroclada Hayata 20g, Caulis Sargentodoxae 40g, Caulis Trachelospermi 20g, extracting in water three times, each amount of water is equivalent to 10 times of medical material gross weight, 2 hours extraction times of first time, 1 hour extraction time of second time, 1 hour extraction time of third time, merge three extracting solution, filter, it is 1.10(80 DEG C that filtrate is concentrated into relative density), add ethanol, alcohol content is made to be 70%, leave standstill 12 hours, filter, when filtrate is concentrated into 80 DEG C, relative density is the extractum of 1.25, dry, pulverize, for subsequent use.Get suitable quantity of water soluble base, after water-bath is dissolved, then add appropriate penetrating agent, stir.Above-mentioned substrate progressively joined in fine powder for subsequent use, stir, after the ointment shape that congeals into, embedding is in ointment tube, to obtain final product.

embodiment 5: the preparation of ointment

Get Radix Zanthoxyli 55g, Fructus Schisandrae Sphenantherae 60g, Cortex Acanthopancis 40g, Herba Lycopodii 25g, Radix Clematidis 40g, Cissus pteroclada Hayata 35g, Caulis Sargentodoxae 35g, Caulis Trachelospermi 35g, extracting in water three times, each amount of water is equivalent to 6 times of medical material gross weight, 3 hours extraction times of first time, 2 hours extraction times of second time, 1 hour extraction time of third time, merge three extracting solution, filter, it is 1.30(80 DEG C that filtrate is concentrated into relative density), add ethanol, alcohol content is made to be 40%, leave standstill 24 hours, filter, when filtrate is concentrated into 80 DEG C, relative density is the extractum of 1.10, dry, pulverize, for subsequent use.Get suitable quantity of water soluble base, after water-bath is dissolved, then add appropriate penetrating agent, stir.Above-mentioned substrate progressively joined in fine powder for subsequent use, stir, after the ointment shape that congeals into, embedding is in ointment tube, to obtain final product.

embodiment 6: the preparation of gel rubber plaster unguentum

Get Radix Zanthoxyli 30g, Fructus Schisandrae Sphenantherae 70g, Cortex Acanthopancis 10g, Herba Lycopodii 10g, Radix Clematidis 50g, Cissus pteroclada Hayata 50g, Caulis Sargentodoxae 20g, Caulis Trachelospermi 40g, add 80% alcohol reflux three times, each amount of alcohol added is 4 times of medical material total amount, extraction time is respectively 3 hours, 2 hours, 1 hour, merge extractive liquid, filter, when filtrate is concentrated into 60 DEG C, relative density is the extractum of 1.25, obtains active component.

Active component adds the adjuvants such as appropriate adhesive, wetting agent, filler, stirs, coats on back lining materials, obtain inventive gel emplastrum.

embodiment 7: the preparation of gel rubber plaster unguentum

Get Radix Zanthoxyli 65, Fructus Schisandrae Sphenantherae 65g, Cortex Acanthopancis 25g, Herba Lycopodii 25g, Radix Clematidis 30g, Cissus pteroclada Hayata 30g, Caulis Sargentodoxae 15g, Caulis Trachelospermi 15g, add 40% alcohol reflux twice, each amount of alcohol added is 10 times of medical material total amount, extraction time is respectively 4 hours, 3 hours, merge extractive liquid, filter, when filtrate is concentrated into 80 DEG C, relative density is the extractum of 1.10, obtains active component.

embodiment 8: the preparation of gel rubber plaster unguentum

Get Radix Zanthoxyli 55, Fructus Schisandrae Sphenantherae 55g, Cortex Acanthopancis 45g, Herba Lycopodii 45g, Radix Clematidis 15g, Cissus pteroclada Hayata 15g, Caulis Sargentodoxae 50g, Caulis Trachelospermi 50g, add 40% alcohol reflux three times, each amount of alcohol added is 8 times of medical material total amount, extraction time is respectively 3 hours, 3 hours, 2 hours, merge extractive liquid, filter, when filtrate is concentrated into 70 DEG C, relative density is the extractum of 1.15, obtains active component.

embodiment 9: the preparation of lotion

Get Radix Zanthoxyli 70g, Fructus Schisandrae Sphenantherae 30g, Cortex Acanthopancis 50g, Herba Lycopodii 20g, Radix Clematidis 10g, Cissus pteroclada Hayata 30g, Caulis Sargentodoxae 50g, Caulis Trachelospermi 10g, add the alcohol dipping 48 hours that the volume by volume concentration being equivalent to this 8 taste medical material gross weight 2 times is 60%, then with volume by volume concentration be 60% ethanol carry out percolation with the speed accounting for raw material gross weight 0.2% per minute, collect the percolate being equivalent to this 8 taste medical material gross weight 10 times amount, reclaim ethanol, be evaporated to 2 times that are equivalent to 8 taste medical material gross weights, filter, filtrate, add 2g glycerol, mixing, obtain lotion.

embodiment 10: the preparation of lotion

Get Radix Zanthoxyli 55g, Fructus Schisandrae Sphenantherae 55g, Cortex Acanthopancis 45g, Herba Lycopodii 40g, Radix Clematidis 50g, Cissus pteroclada Hayata 10g, Caulis Sargentodoxae 50g, Caulis Trachelospermi 10g, add the alcohol dipping 12 hours that the volume by volume concentration being equivalent to this 8 taste medical material gross weight 1 times is 40%, then with volume by volume concentration be 40% ethanol carry out percolation with the speed accounting for raw material gross weight 0.6% per minute, collect the percolate being equivalent to this 8 taste medical material gross weight 5 times amount, reclaim ethanol, be evaporated to 1 times that is equivalent to 8 taste medical material gross weights, filter, filtrate, add 1.5g glycerol, mixing, obtain lotion.

embodiment 11: the preparation of powder

Get Radix Zanthoxyli 50g, Fructus Schisandrae Sphenantherae 40g, Cortex Acanthopancis 30g, Herba Lycopodii 50g, Radix Clematidis 20g, Cissus pteroclada Hayata 10g, Caulis Sargentodoxae 40g, Caulis Trachelospermi 50g, extracting in water three times, each amount of water is equivalent to 8 times of medical material gross weight, each extraction time is respectively 2 hours, 1 hour, 1 hour, merge extractive liquid, filters, concentrated, adding ethanol makes alcohol content be 70%, leave standstill 12 hours, elimination precipitate, dry, pulverize, obtain the powder of Chinese medicine composition of the present invention.

embodiment 12: the preparation of powder

Get Radix Zanthoxyli 30g, Fructus Schisandrae Sphenantherae 30g, Cortex Acanthopancis 10g, Herba Lycopodii 50g, Radix Clematidis 30g, Cissus pteroclada Hayata 50g, Caulis Sargentodoxae 50g, Caulis Trachelospermi 30g, extracting in water twice, each amount of water is equivalent to 12 times of medical material gross weight, each extraction time is 3 hours, merge extractive liquid, filters, concentrated, adding ethanol makes alcohol content be 50%, leave standstill 48 hours, elimination precipitate, dry, pulverize, obtain the powder of Chinese medicine composition of the present invention.

clinical treatment is summed up

The selection of 1 case

1.1 criteria for classifications: the rheumatoid arthritis criteria for classification adopting American Rheumatism Association's revision in 1987

1.1.1 deadlock at least 1 hour in morning (>=6 weeks)

1.1.2 more than 3 or 3 hinge area swollen joints (>=6 weeks)

1.1.3 wrist, metacarpophalangeal joints or near-end close between referring to. joint swollen (>=6 weeks)

1.1.4 symmetry swollen joint (>=6 weeks)

1.1.5 subcutaneous nodule

1.1.6 both hands X-ray changes

1.1.7 rheumatoid factor positive (titre > 1:32)

All patients all meet more than 4 or 4 in above-mentioned 7

1.2 inclusive criterias: 1. allly simultaneously meet above-mentioned doctor trained in Western medicine criteria for classification, TCM syndrome diagnostic criteria patient; 2. 18-65 age, person year; 3. function of joint I-III grade of person; 4. acceptance 2 weeks therapists are ready; 5. signature enters clinical research Informed Consent Form person.

Function of joint grade scale:

I grade of functional status is intact, and daily routines are unrestricted.

II grade of energy normal activity, but have one or more joint motion limited or uncomfortable.

III grade of joint motion is limited, can only be competent at a part or the general occupational task that grosses incompetence, or can not take care of number one well.

IV grade of major part or completely lose mobility, life cannot be taken care of oneself.

1.3 exclusion standards: 1. do not meet above-mentioned criteria for classification and inclusive criteria; 2. accepted other associated therapy, this research effect index observer may have been affected; 3. the serious life-threatening primary diseases such as cardiovascular and cerebrovascular vessel, liver, kidney and hemopoietic system are merged, diabetes and psychotic; 4. the age is under-18s or over-65s patient; 5. gestation or age of sucking patient; 6. patients with terminal, joint severe deformities, function of joint IV grade of person; 7. other autoimmune disease is merged, other rheumatism such as serious knee osteoarthritis patient; 8. to drug allergy person used; 9. local skin ulceration, sepage, there is pus infections and have skin infection patient; 10. 2 weeks therapists can not be accepted.

2 medicines

Embodiment 1-3: prepare by embodiment method

Meloxicam tablet: purchased from Shanghai Boehringer Ingelheim pharmaceutcal corporation, Ltd

Methotrexate sheet: purchased from Shanghai Sine Pharmaceutical Co., Ltd.

3 treatment groupings

Treatment group: the medicine using the embodiment of the present invention 1.

Matched group: take meloxicam tablet, methotrexate sheet.

4 Therapeutic Method

Embodiment group: the medicine of the embodiment of the present invention 1, the mode of hot compress after adopting towel to absorb the drug.Every day 1 time, each 20 minutes, 7 was 1 course for the treatment of, was used in conjunction for 2 courses for the treatment of.

Matched group: meloxicam tablet 15mg, every day 1 time; Methotrexate sheet 10mg, 1 time weekly.

5 observation index

Tenderness is closed joint number, is swollen and ache and close joint number, erythrocyte sedimentation rate

Observe totally 28, joint: comprise both shoulders, duplex, two wrist, both hands metacarpophalangeal joints, both hands proximal interphalangeal joint, double knee joint

6 evaluation methodologys:

The improvement Disease Activity standard (3 variable) of European rheumatism Leagues enact [modified disease activity score (3 variables) is called for short DAS28-3] is adopted to judge conditions of patients activeness.

DAS28-3 scores with 28 joints: comprise both shoulders, duplex, two wrist, both hands metacarpophalangeal joints, both hands proximal interphalangeal joint, double knee joint.

DAS28-3=(0.56 × tenderness number+0.28 × swelling number+0.70 × erythrocyte sedimentation rate) × 1.08+0.16

Catabasis DAS28-3≤2.6 point

Low activeness 2.6 points of < DAS28-3≤3.2 point

Medium activity 3.2 points of < DAS28-3≤5.1 point

High activeness DAS28-3>5.1 divides.

7 results

Group	Number of cases	Before treatment	After treatment
				Embodiment 1	30	5.12±0.78	2.71±0.69*△
Matched group 1	30	5.16±0.81	3.53±0.76*

Note: * compares before representing the treatment of this group, P<0.05; △ represents that treatment group compares with matched group group, P<0.05.

Upper table result display: after embodiment 1, treatment of control group, the state of an illness is all improved, and embodiment 1, compared with the effect after treatment of control group, has significant difference (P<0.05).

Result shows: Chinese medicine composition provided by the invention has the effect improving rheumatoid arthritis knuckle and swell and ache, and effect is better than matched group, compared with matched group, has significant difference.

model case

1, Wang, female, 56 years old, Liuzhou City Liujiang man, in May, 2012 goes to a doctor, and extremities joint swells and ache more than 3 years repeatedly, once the treatment such as methotrexate, meloxicam was taken, but still have both hands proximal interphalangeal joint to swell and ache, through the drug coat of the embodiment of the present invention 4 in affected part, treat both hands proximal interphalangeal joint after 2 weeks and to swell and ache basic disappearance.

2, Zhang, female, 52 years old, people from Liuzhou, in March, 2012 goes to a doctor, extremities joint swells and ache more than 5 years repeatedly, previously once tosses about in bed Guangxi Duo Jia hospital and clinic treatment, after treatment, Morbidity control still can, but still leave over right carpal joint swelling and pain, use the medicine hot compress of the embodiment of the present invention 6 to apt affected part, after treating 3 times, namely symptom is improved.

3, Wei, female, 48 years old, people from Liuzhou, in JIUYUE, 2012 is gone to a doctor, and extremities joint swells and ache more than 6 years repeatedly, once the treatments such as leflunomide, sulfasalazine, oxychloroquine were used, now still have two knee joint, right ankle swells and ache, limitation of activity, after the embodiment of the present invention 9 medicine heating foam washing treats 10 days, symptom is alleviated substantially.

4, the Qin, man, 60 years old, people from Rong'an, Guangxi, in JIUYUE, 2012 is gone to a doctor, and extremities joint swells and ache more than 10 years repeatedly, once uses prednisone, methotrexate etc. to treat for many years, and still has left shoulder pain, limitation of activity, the medicine hot compress through the embodiment of the present invention 11 is pressed treatment 7 days rear left shoulder pains and is disappeared, and activity freely.

Although above with general explanation, detailed description of the invention and test, the present invention is described in detail, and on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, all belong to the scope of protection of present invention.

Claims

1. improve a Chinese medicine composition for rheumatoid arthritis arthralgia, it is characterized in that it is prepared from by the raw material of following weight portion:

Radix Zanthoxyli 70-30 parts, Fructus Schisandrae Sphenantherae 70-30 parts, Cortex Acanthopancis 50-10 parts, Herba Lycopodii 50-10 parts, Radix Clematidis 50-10 parts, Cissus pteroclada Hayata 50-10 parts, Caulis Sargentodoxae 50-10 parts, Caulis Trachelospermi 50-10 parts.

2. Chinese medicine composition according to claim 1, is characterized in that it is prepared from by the raw material of following weight portion:

Radix Zanthoxyli 60-40 parts, Fructus Schisandrae Sphenantherae 60-40 parts, Cortex Acanthopancis 40-20 parts, Herba Lycopodii 40-20 parts, Radix Clematidis 40-20 parts, Cissus pteroclada Hayata 40-20 parts, Caulis Sargentodoxae 40-20 parts, Caulis Trachelospermi 40-20 parts.

3. Chinese medicine composition according to claim 1, is characterized in that it is prepared from by the raw material of following weight portion:

4., according to the Chinese medicine composition of claim 1-3 described in any one, it is characterized in that its active component is prepared from by the following method:

Get whole 8 taste medical materials, Soakage extraction 3-4 time, add medical material gross weight 2-4 50-90% alcohol dipping 12-60 hour doubly at every turn, incline and get supernatant, squeezing medicinal residues, merge supernatant and pressed liquor, filter, are concentrated into and are equivalent to medical material gross weight 4 ~ 6 times, to obtain final product.

5., according to the Chinese medicine composition of claim 1-3 described in any one, it is characterized in that its active component is prepared from by the following method:

Get whole 8 taste medical materials, extracting in water 2-3 time, each amount of water is equivalent to the 6-12 of medical material gross weight doubly, each extraction time is 1-3 hour, merge extractive liquid, filter, it is the extractum of 1.10-1.30 that filtrate is concentrated into relative density at 80 DEG C, add ethanol, make alcohol content be 40-70%, leave standstill 12-24 hour, filter, when filtrate is concentrated into 80 DEG C, relative density is the extractum of 1.10-1.25, to obtain final product.

6., according to the Chinese medicine composition of claim 1-3 described in any one, it is characterized in that its active component is prepared from by the following method:

Get whole 8 taste medical materials, with 40-80% alcohol reflux 2-3 time, each ethanol consumption be the 4-10 of medical material total amount doubly, extraction time is 1-4 hour, merge extractive liquid, filters, and when filtrate is concentrated into 60-80 DEG C, relative density is the extractum of 1.10-1.25, to obtain final product.

7., according to the Chinese medicine composition of claim 1-3 described in any one, it is characterized in that its active component is prepared from by the following method:

Get whole 8 taste medical materials, add be equivalent to this 8 taste medical material gross weight 1 ~ 2 times 40% ~ 60% alcohol dipping 12 ~ 48 hours, then percolation is carried out with the ethanol of 40% ~ 60% with the speed accounting for raw material gross weight 0.2% ~ 0.6% per minute, collect the percolate being equivalent to this 8 taste medical material gross weight 5-10 times amount, reclaim ethanol, be evaporated to 1 ~ 2 times that is equivalent to 8 taste medical material gross weights, filter, obtain medicinal liquid A; Medicinal liquid A is active component.

8. Chinese medicine composition according to claim 7, is characterized in that its active component is prepared from by the following method:

Get whole 8 taste medical materials, add the alcohol dipping 24 ~ 36 hours that the volume by volume concentration being equivalent to this 8 taste medical material gross weight 1 ~ 2 times is 50% ~ 56%, then with volume by volume concentration be 50% ~ 56% ethanol carry out percolation with the speed accounting for raw material gross weight 0.3% ~ 0.5% per minute, collect the percolate being equivalent to this 8 taste medical material gross weight 5-10 times amount, reclaim ethanol, be evaporated to 1 ~ 2 times that is equivalent to 8 taste medical material gross weights, filter, obtain medicinal liquid A; Medicinal liquid A is active component.

9., according to the Chinese medicine composition of claim 1-3 described in any one, it is characterized in that its powder is prepared from by the following method:

Get whole 8 taste medical materials, extracting in water 2-3 time, each amount of water is equivalent to the 8-12 of medical material gross weight doubly, and each extraction time is 1-3 hour, merge extractive liquid, filter, concentrated, add ethanol and make alcohol content be 50-70%, leave standstill 12-48 hour, elimination precipitate, dry, pulverize, and to obtain final product.

10. improve a Chinese medicine preparation for rheumatoid arthritis arthralgia, Chinese medicine composition and the pharmaceutically acceptable carrier of the improvement rheumatoid arthritis arthralgia any one of claims 1 to 3 are made.