CN104398757A - Traditional Chinese medicine for treating rheumatoid arthritis and preparation method thereof - Google Patents
Traditional Chinese medicine for treating rheumatoid arthritis and preparation method thereof Download PDFInfo
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- CN104398757A CN104398757A CN201410689475.6A CN201410689475A CN104398757A CN 104398757 A CN104398757 A CN 104398757A CN 201410689475 A CN201410689475 A CN 201410689475A CN 104398757 A CN104398757 A CN 104398757A
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- chinese medicine
- rhizoma
- rheumatoid arthritis
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Abstract
The invention belongs to the technical field of medicines, and in particular discloses a traditional Chinese medicine for treating rheumatoid arthritis. The traditional Chinese medicine consists of the following raw materials: long-noded pit viper, radix angelicae pubescentis, angelica sinensis, carthamus tinctorius, homalomena occulta, buthus martensii, Paris polyphylla, sea horses, coptis chinensis, rhizoma cibotii, cocklebur fruit, radix bupleuri, cassia twig, buffalo horns, indigo naturalis, rosa banksiae and folium artemisiae argyi. The traditional Chinese medicine has the effects of nourishing liver and kidney, removing toxicity to remove swelling, dispelling wind and eliminating dampness, promoting blood circulation to remove meridian obstruction, strengthening tendons and bones, expelling wind and removing cold as well as strengthening body resistance and eliminating evil, and the purpose of treating both symptoms and root causes is achieved.
Description
Technical field
The present invention relates to medical art, particularly relate to a kind of Chinese medicine being used for the treatment of rheumatoid arthritis and preparation method thereof.
Background technology
Rheumatoid arthritis (RA) is a kind of periarticular that involves is the struvite autoimmune disease of main multisystem.Clinical characters is affected joints pain and swelling, function reduction, and pathological changes is continue, recurrent exerbation process, disability rate higher (can reach more than 40%).Patient with severe symptoms joint is fibroid or bony ankylosis, and loses function of joint because of periarticular muscles atrophy, spasm, causes and can't take care of oneself.Except joint symptoms, also can occur outside joint or visceral lesion, as rheumatoid nodules, the pathological changes such as the heart, lung, kidney, peripheral nerve and eye.Pathological changes is in lasting, recurrent exerbation.Rheumatoid arthritis is as clinical common difficult diseases, and its disability rate is high, directly affects the quality of life of patient.
The pathogenesis of rheumatoid arthritis is not fully aware of at present, but most scholar thinks that the pathogenesis of primary disease is in infective agent, under inherited genetic factors combined effect, the autoimmune disease occurred in the presence of endocrine factors ~ hypothalamus ~ hypophysis ~ hypothalamic pituitary adrenal axis.Although the pathogenesis of rheumatoid arthritis is not yet very clear and definite, so far without satisfied medicine.At present, the drug main for the treatment of rheumatoid arthritis will divide two classes:
One class is non-steroidal anti-inflammatory drugs (non-steroidalanti-inflammatorydrugs, NSAIDs);
One class is disease antirheumatic; (Disease-modifying antirheumatic drugs, DMARDs).
NSAIDs is the choice drug for the treatment of RA, comprises salicylic acid, traditional non-steroidal anti-inflammatory drugs and selective epoxidation enzyme-2 (Cyclo-oxgenase-2, COX-2) inhibitor.Patient occurs that the first few week interior NSAIDs of symptom has extraordinary curative effect, but NSAIDs Main Function alleviates RA patient articular pain, swelling and improves function of joint, be difficult to stop advancing of disease, the destruction in joint can not be prevented, make it apply to gastrointestinal serious adverse reaction in addition and be restricted;
DMARDs as methotrexate (methotrexate, MTX) can be also lasting fast inflammation-inhibiting, but due to toxic action large, the in addition expensive price limit application of these medicines in RA.Recent study persons find treatment opportunity from all angles, and Chinese herbal medicine is treated with its hypotoxicity, Mutiple Targets and the feature of cheapness more and more comes into one's own, and becomes the new focus of research and development treatment RA medicine.
Rheumatoid arthritis belongs to the category such as the traditional Chinese medical science " rheumatism involving the bone ", " bone fistula ", in close relations with Liver and kidney, liver blood deficiency of kidney-essence, can cause insufficiency of vital energy and blood, muscles and bones mistake is supported, coagulation of QI-blood and primary disease occurs.Chinese medicine primary treatment principle is relaxing muscles and tendons and activating QI and blood in the collateral, expelling wind and removing dampness, strengthening the tendons and bones, liver and kidney tonifying, and curative effect is obvious, and side reaction is few and light; Primary disease belongs to the category such as the traditional Chinese medical science " numbness is sick ", " insensitive impediment ", " rheumatoid arthritis " or " severe and migratory arthralgia ".Treatment by Chinese herbs is wet to eliminate the phlegm, liver and kidney tonifying, and filling blood is its main Therapeutic Principle.Treatment by Chinese herbs rheumatoid arthritis has few and light, the eutherapeutic advantage of clinical side reaction.
Summary of the invention
Not very desirable problem to solve current rheumatoid arthritis treatment situation, the invention provides a kind of Chinese medicine being used for the treatment of rheumatoid arthritis and preparation method thereof.
The technical scheme that the present invention takes is:
The Chinese medicine being used for the treatment of rheumatoid arthritis of the present invention is made up of the raw material of following weight portion: Agkistrodon 30-120, Radix Angelicae Pubescentis 100-200, Radix Angelicae Sinensis 110-180, Flos Carthami 130-220, Rhizoma Homalomenae 90-210, Scorpio 80-150, Rhizoma Paridis 100-180, Hippocampus 50-100, Rhizoma Coptidis 80-170, Rhizoma Cibotii 70-150, Fructus Xanthii 70-160, Radix Bupleuri 40-120, Ramulus Cinnamomi 70-170, Cornu Bubali 20-60, Indigo Naturalis 30-80, Radix Aucklandiae 40-80, Folium Artemisiae Argyi 50-90.
Preferably, the above-mentioned Chinese medicine being used for the treatment of rheumatoid arthritis is made up of the raw material of following weight portion: Agkistrodon 30-100, Radix Angelicae Pubescentis 120-200, Radix Angelicae Sinensis 120-180, Flos Carthami 130-200, Rhizoma Homalomenae 90-190, Scorpio 90-150, Rhizoma Paridis 120-180, Hippocampus 60-100, Rhizoma Coptidis 100-170, Rhizoma Cibotii 80-150, Fructus Xanthii 70-130, Radix Bupleuri 60-120, Ramulus Cinnamomi 70-150, Cornu Bubali 30-60, Indigo Naturalis 30-70, Radix Aucklandiae 40-70, Folium Artemisiae Argyi 60-90.
One of preferred technical scheme further: the Chinese medicine being used for the treatment of rheumatoid arthritis of the present invention is made up of the raw material of following weight portion: Agkistrodon 30, Radix Angelicae Pubescentis 200, Radix Angelicae Sinensis 120, Flos Carthami 200, Rhizoma Homalomenae 90, Scorpio 150, Rhizoma Paridis 120, Hippocampus 100, Rhizoma Coptidis 100, Rhizoma Cibotii 150, Fructus Xanthii 70, Radix Bupleuri 120, Ramulus Cinnamomi 70, Cornu Bubali 60, Indigo Naturalis 30, the Radix Aucklandiae 70, Folium Artemisiae Argyi 60.
Preferred technical scheme two further: the Chinese medicine being used for the treatment of rheumatoid arthritis of the present invention is made up of the raw material of following weight portion: Agkistrodon 100, Radix Angelicae Pubescentis 120, Radix Angelicae Sinensis 180, Flos Carthami 130, Rhizoma Homalomenae 190, Scorpio 90, Rhizoma Paridis 180, Hippocampus 60, Rhizoma Coptidis 170, Rhizoma Cibotii 80, Fructus Xanthii 130, Radix Bupleuri 60, Ramulus Cinnamomi 150, Cornu Bubali 30, Indigo Naturalis 70, the Radix Aucklandiae 40, Folium Artemisiae Argyi 90.
Most preferred technical scheme: the Chinese medicine being used for the treatment of rheumatoid arthritis of the present invention is made up of the raw material of following weight portion: Agkistrodon 60, Radix Angelicae Pubescentis 150, Radix Angelicae Sinensis 160, Flos Carthami 180, Rhizoma Homalomenae 130, Scorpio 100, Rhizoma Paridis 140, Hippocampus 70, Rhizoma Coptidis 120, Rhizoma Cibotii 100, Fructus Xanthii 110, Radix Bupleuri 80, Ramulus Cinnamomi 110, Cornu Bubali 40, Indigo Naturalis 50, the Radix Aucklandiae 60, Folium Artemisiae Argyi 70.
The dosage form being used for the treatment of the Chinese medicine of rheumatoid arthritis of the present invention is decoction, tablet, capsule, injection or granule.
The concrete steps being used for the treatment of the preparation method of the Chinese medicine of rheumatoid arthritis of the present invention are as follows:
(1) first take traditional Chinese medicinal material raw materials by proportioning, then put into Chinese medicine grinder respectively and pulverize, grinding and sieving;
(2) fine drug powder of the Agkistrodon of step (1) being prepared, Radix Angelicae Pubescentis, Flos Carthami, Rhizoma Homalomenae, Scorpio, Rhizoma Paridis, Hippocampus, Fructus Xanthii, Ramulus Cinnamomi, Cornu Bubali, Indigo Naturalis, the Radix Aucklandiae and Folium Artemisiae Argyi adds in reactor, add the dehydrated alcohol of 5-15 times amount, heating and refluxing extraction 3-7 hour, extracting solution is collected after cooling, and then in reactor, add the water of 2-7 times amount, heating and refluxing extraction 1-4 hour, collect extracting solution after cooling, then merge the extracting solution of twice, leave standstill and obtain supernatant;
(3) at supernatant heating being concentrated into 50 DEG C, relative density is 1.10-1.20, obtains thick paste;
(4) in thick paste, add the fine drug powder of Radix Angelicae Sinensis, Rhizoma Cibotii, Radix Bupleuri and Rhizoma Coptidis, then drying obtains dry extract;
(5) carried out by dry extract pulverizing, sieving, then add adjuvant, mixing, makes required dosage form according to a conventional method.
In step (1), medicine crosses 200 mesh sieves after pulverizing.
In step (2), preferably add the dehydrated alcohol of 10 times amount, heating and refluxing extraction 5 hours.
In step (2), preferably add the water of 5 times amount, heating and refluxing extraction 3 hours.
In step (3), at preferably heating is concentrated into 50 DEG C, relative density is 1.15.
Theory of Chinese medical science thinks that arthromyodynia is that wet three gas of wind and cold are mixed extremely, and combined into numbness, its migratory BI-syndrome caused mainly by pathogenic wind, BI-syndrome caused mainly by pathogenic cold being called painful BI, dampness victor is disease, and the many persons of yang-energy are pyretic arthralgia.The institute of numbness is raw, is to wet more, wet genus YIN pathogen, and itself and wind and cold heresy are harmonious, and cold-damp numbness occurs, and its pyretic arthralgia also makes sun suffer cloudy wound due to YIN pathogen.Its pathogenesis of rheumatoid arthritis for suffering from a deficiency of the kidney, irritability is uncomfortable reaches, attacked by the cold and evil enters stomach, and meridian qi and blood is not all right, and joint is puckery to be closed, and muscles and bones mistake is supported, and gradually to clonic spasm of the muscle bone pine, joint deformity, must not bend and stretch.
The Chinese medicine being used for the treatment of rheumatoid arthritis of the present invention chooses Agkistrodon, Radix Angelicae Pubescentis, Radix Angelicae Sinensis, Flos Carthami, Rhizoma Homalomenae and Scorpio as monarch drug;
Agkistrodon sweet-salty, warm in nature, there is the drug effects such as wind-damp dispelling, dispersing wind and cold, relaxing muscles and tendons and activating QI and blood in the collateral;
Radix Angelicae Pubescentis acrid in the mouth, hardship, tepor.Return liver, kidney, urinary bladder channel.There is expelling wind and dampness; Effect of dispersing cold for relieving pain.For anemofrigid-damp arthralgia; The treatment of lumbocrural pain;
Radix Angelicae Sinensis sweet in the mouth, pungent, warm, return liver, the heart, spleen channel.Have and enrich blood; Invigorate blood circulation; Menstruction regulating and pain relieving; Moisturize effect of laxation;
Flos Carthami acrid in the mouth, temperature, is included into the heart, Liver Channel.There is promoting blood circulation to restore menstrual flow, effect of blood stasis removing pain relieving;
Rhizoma Homalomenae gas is fragrant, acrid in the mouth, micro-hardship.Property pungent, temperature.Mild toxicity.Be included into liver; Kidney; Stomach warp.There is the effects such as wind-damp dispelling, relaxing muscles and tendons and activating QI and blood in the collateral, pain relieving, detumescence.
Function that Scorpio has " spasmolytic that relieves dizziness, high fever, infantile convulsions, epilepsy, etc., antiinflammatory counteracting toxic substances, removing obstruction in the collateral to relieve pain ".
The Chinese medicine being used for the treatment of rheumatoid arthritis of the present invention chooses Rhizoma Paridis, Hippocampus, Daphne giraldii Nitsche, Rhizoma Coptidis and Rhizoma Cibotii as ministerial drug;
Rhizoma Paridis bitter in the mouth, is slightly cold; Slightly poisonous.Return Liver Channel.There is heat-clearing and toxic substances removing, reducing swelling and alleviating pain, effect of cool liver arresting convulsion;
Hippocampus has effect of building body, kidney invigorating and YANG supporting, relaxing muscles and tendons and activating QI and blood in the collateral, anti-inflammatory analgetic, tranquillizing and allaying excitement;
Daphne giraldii Nitsche has expelling wind and removing dampness, effect of pain relieving dissipating blood stasis;
Rhizoma Coptidis has heat clearing and damp drying, effect of eliminating fire and detoxication;
Rhizoma Cibotii bitter but sweet flavor, temperature.Enter liver, kidney channel.There is invigorating the liver and kidney, wind-damp dispelling, strong waist foot, the effect in sharp joint.
The Chinese medicine being used for the treatment of rheumatoid arthritis of the present invention chooses Fructus Xanthii, Radix Bupleuri, Ramulus Cinnamomi and Cornu Bubali as adjuvant drug;
Fructus Xanthii bitter in the mouth, sweet, pungent, warm in nature.Return lung, Liver Channel.There is dispersing wind-cold, clearing the nasal passage, wind-damp dispelling, effect of pain relieving;
Radix Bupleuri bitter in the mouth, is slightly cold.Return liver, gallbladder meridian.There is reconciling superficies and interior, soothing the liver, effect of yang invigorating;
Ramulus Cinnamomi taste acrid, sweet, warm.GUIXIN, lung, urinary bladder channel.There is diaphoresis expelling pathogenic factors from muscles, promoting the flow of QI-blood by warming the meridian, supporing yang activating QI, effect of the flat gas that spins;
Cornu Bubali has heat clearing away, removing heat from blood, arresting convulsion, effect of removing toxic substances.
The Chinese medicine being used for the treatment of rheumatoid arthritis of the present invention chooses Indigo Naturalis, the Radix Aucklandiae and Folium Artemisiae Argyi as making medicine;
Indigo Naturalis has heat-clearing and toxic substances removing, blood cooling and ecchymoses removing, effect of pathogenic fire purging arresting convulsion;
Radix Aucklandiae acrid in the mouth; Bitter; Warm in nature.Gui Jing: return spleen; Large intestine, tri-jiao channel.There is circulation of qi promoting, pain relieving, spleen invigorating, the effect helped digestion;
Folium Artemisiae Argyi has blood of regulating the flow of vital energy, by cold-damp; Warming the meridian, effect of hemostasis.
The Chinese medicine being used for the treatment of rheumatoid arthritis of the present invention has effect of nourishing the liver and kidney, removing toxic substances and promoting subsidence of swelling, expelling wind and removing dampness, promoting blood circulation to remove obstruction in the collateral, strengthening the tendons and bones, expelling wind and cold and strengthening vital QI to eliminate pathogenic factors, reaches the object for the treatment of both the principal and secondary aspects of a disease.Prove through pharmacodynamics and clinical trial, medicine of the present invention has good therapeutic effect to rheumatoid arthritis, and does not occur large untoward reaction.
Detailed description of the invention
The following examples describe in further detail of the present invention.
Embodiment 1
1.1 raw materials composition (g):
Agkistrodon 30, Radix Angelicae Pubescentis 200, Radix Angelicae Sinensis 120, Flos Carthami 200, Rhizoma Homalomenae 90, Scorpio 150, Rhizoma Paridis 120, Hippocampus 100, Rhizoma Coptidis 100, Rhizoma Cibotii 150, Fructus Xanthii 70, Radix Bupleuri 120, Ramulus Cinnamomi 70, Cornu Bubali 60, Indigo Naturalis 30, the Radix Aucklandiae 70, Folium Artemisiae Argyi 60.
1.2 preparation methoies:
(1) first take traditional Chinese medicinal material raw materials by proportioning, then put into Chinese medicine grinder respectively and pulverize, grinding and sieving;
(2) fine drug powder of the Agkistrodon of step (1) being prepared, Radix Angelicae Pubescentis, Flos Carthami, Rhizoma Homalomenae, Scorpio, Rhizoma Paridis, Hippocampus, Fructus Xanthii, Ramulus Cinnamomi, Cornu Bubali, Indigo Naturalis, the Radix Aucklandiae and Folium Artemisiae Argyi adds in reactor, add the dehydrated alcohol of 5 times amount, heating and refluxing extraction 3 hours, extracting solution is collected after cooling, and then in reactor, adding the water of 2 times amount, heating and refluxing extraction 1 hour, collects extracting solution after cooling, then merge the extracting solution of twice, leave standstill and obtain supernatant;
(3) at supernatant heating being concentrated into 50 DEG C, relative density is 1.10, obtains thick paste;
(4) in thick paste, add the fine drug powder of Radix Angelicae Sinensis, Rhizoma Cibotii, Radix Bupleuri and Rhizoma Coptidis, then drying obtains dry extract;
(5) carried out by dry extract pulverizing, sieving, then add adjuvant, mixing, makes tablet according to a conventional method.
In step (1), medicine crosses 200 mesh sieves after pulverizing.
Embodiment 2
2.1 raw materials composition (g):
Agkistrodon 100, Radix Angelicae Pubescentis 120, Radix Angelicae Sinensis 180, Flos Carthami 130, Rhizoma Homalomenae 190, Scorpio 90, Rhizoma Paridis 180, Hippocampus 60, Rhizoma Coptidis 170, Rhizoma Cibotii 80, Fructus Xanthii 130, Radix Bupleuri 60, Ramulus Cinnamomi 150, Cornu Bubali 30, Indigo Naturalis 70, the Radix Aucklandiae 40, Folium Artemisiae Argyi 90.
2.2 preparation methoies:
(1) first take traditional Chinese medicinal material raw materials by proportioning, then put into Chinese medicine grinder respectively and pulverize, grinding and sieving;
(2) fine drug powder of the Agkistrodon of step (1) being prepared, Radix Angelicae Pubescentis, Flos Carthami, Rhizoma Homalomenae, Scorpio, Rhizoma Paridis, Hippocampus, Fructus Xanthii, Ramulus Cinnamomi, Cornu Bubali, Indigo Naturalis, the Radix Aucklandiae and Folium Artemisiae Argyi adds in reactor, add the dehydrated alcohol of 15 times amount, heating and refluxing extraction 7 hours, extracting solution is collected after cooling, and then in reactor, adding the water of 7 times amount, heating and refluxing extraction 4 hours, collects extracting solution after cooling, then merge the extracting solution of twice, leave standstill and obtain supernatant;
(3) at supernatant heating being concentrated into 50 DEG C, relative density is 1.20, obtains thick paste;
(4) in thick paste, add the fine drug powder of Radix Angelicae Sinensis, Rhizoma Cibotii, Radix Bupleuri and Rhizoma Coptidis, then drying obtains dry extract;
(5) carried out by dry extract pulverizing, sieving, then add adjuvant, mixing, makes capsule according to a conventional method.
In step (1), medicine crosses 200 mesh sieves after pulverizing.
Embodiment 3
3.1 raw materials composition (g)
Agkistrodon 60, Radix Angelicae Pubescentis 150, Radix Angelicae Sinensis 160, Flos Carthami 180, Rhizoma Homalomenae 130, Scorpio 100, Rhizoma Paridis 140, Hippocampus 70, Rhizoma Coptidis 120, Rhizoma Cibotii 100, Fructus Xanthii 110, Radix Bupleuri 80, Ramulus Cinnamomi 110, Cornu Bubali 40, Indigo Naturalis 50, the Radix Aucklandiae 60, Folium Artemisiae Argyi 70.
3.2 preparation methoies:
(1) first take traditional Chinese medicinal material raw materials by proportioning, then put into Chinese medicine grinder respectively and pulverize, grinding and sieving;
(2) fine drug powder of the Agkistrodon of step (1) being prepared, Radix Angelicae Pubescentis, Flos Carthami, Rhizoma Homalomenae, Scorpio, Rhizoma Paridis, Hippocampus, Fructus Xanthii, Ramulus Cinnamomi, Cornu Bubali, Indigo Naturalis, the Radix Aucklandiae and Folium Artemisiae Argyi adds in reactor, add the dehydrated alcohol of 10 times amount, heating and refluxing extraction 5 hours, extracting solution is collected after cooling, and then in reactor, adding the water of 5 times amount, heating and refluxing extraction 3 hours, collects extracting solution after cooling, then merge the extracting solution of twice, leave standstill and obtain supernatant;
(3) at supernatant heating being concentrated into 50 DEG C, relative density is 1.15, obtains thick paste;
(4) in thick paste, add the fine drug powder of Radix Angelicae Sinensis, Rhizoma Cibotii, Radix Bupleuri and Rhizoma Coptidis, then drying obtains dry extract;
(5) carried out by dry extract pulverizing, sieving, then add adjuvant, mixing, makes granule according to a conventional method.
pharmacology pharmacodynamic is studied
1 impact on mice capillary permeability
1.1 laboratory animal
KM mice, male and female dual-purpose, body weight 20-28g, is provided by China Medical Science academy animal center breeding field.
1.2 experimental drug
Granule prepared by the embodiment of the present invention 3; Hydrocortisone injection, Tianjin Pharmaceutical Jiaozuo Co., Ltd. produces, and concentration is 5mg/ml, indometacin, and Tianjin Lik-Sang pharmaceutical factory produces.
1.3 experimental technique
50 mices are divided into 5 groups at random, medicine high dose group of the present invention, dosage group in medicine of the present invention, medicine low dose group of the present invention, hydrocortisone group, normal saline group.Often organize 10, male and female half and half, gavage (ig) administration respectively, once a day, successive administration 4 days, normal saline group gives isometric normal saline, after last administration 30 minutes, give every mouse mainline (iv) Evans Blue solution (1.0% concentration) 0.08ml respectively, lumbar injection (ip) glacial acetic acid solution (0.5% concentration) 0.4ml simultaneously, animal is put to death after 20 minutes, cut open the belly and rinse with 5ml normal saline (NS) dyestuff that abdominal cavity blood capillary oozes out, collect eluent, blank is done with normal saline, survey traps to average to compare with matched group at 722 spectrophotometer 580nm wavelength places, carry out statistical test, the results are shown in Table 1.Result shows that oral administration of the present invention to the inhibitory action of mouse peritoneal capillary permeability clearly, illustrates that the effect of medicine anti-experimental character peritonitis of the present invention is very strong.
Table 1
*P＜0.05，**P＜0.01，***P＜0.001
2 impacts on Mus dropsy of ear
2.1 laboratory animal
KM mice, male and female dual-purpose, body weight 20-28g, is provided by China Medical Science academy animal center breeding field.
2.2 experimental drug
Granule prepared by the embodiment of the present invention 3; Hydrocortisone injection, Tianjin Pharmaceutical Jiaozuo Co., Ltd. produces, and concentration is 5mg/ml, indometacin, and Tianjin Lik-Sang pharmaceutical factory produces.
2.3 experimental technique
50 mices are divided into 5 groups at random, medicine high dose group of the present invention, dosage group in medicine of the present invention, medicine low dose group of the present invention, hydrocortisone group, normal saline group.Often organize 10, male and female half and half, gavage (ig) administration respectively, once a day, successive administration 4 days, normal saline group gives isometric normal saline, after last administration 30 minutes, be coated with proinflammatory agent (2% Oleum Tiglii to respectively every left ear of mice, 73% ether, 20% dehydrated alcohol, 5% distilled water), dosage is 4/ear, to cause Mus dropsy of ear, auris dextra compares, mice is put to death after 2 hours, with the card punch of 9nm diameter, circular auricle is laid respectively at same position, torsion balance is weighed, heavily deducting auris dextra sheet recast with left auricle is Mus dropsy of ear degree, average and to compare with normal saline group, carry out statistical test, the results are shown in Table 2, result shows that medicine of the present invention has obviously inhibitory action to Mus dropsy of ear, illustrate that medicine of the present invention has very strong anti-experimental character edema effect.
Table 2
*P＜0.05，**P＜0.01，***P＜0.001
3 impacts that Mus foot is swollen
3.1 laboratory animal
KM mice, male and female dual-purpose, body weight 20-28g, is provided by China Medical Science academy animal center breeding field.
3.2 experimental drug
Granule prepared by the embodiment of the present invention 3; Hydrocortisone injection, Tianjin Pharmaceutical Jiaozuo Co., Ltd. produces, and concentration is 5mg/ml, indometacin, and Tianjin Lik-Sang pharmaceutical factory produces.
3.3 experimental technique
50 mices are divided into 5 groups at random, medicine high dose group of the present invention, dosage group in medicine of the present invention, medicine low dose group of the present invention, hydrocortisone group, normal saline group.Often organize 10, male and female half and half, gavage (ig) administration respectively, once a day, successive administration 4 days, normal saline group gives isometric normal saline, after last administration 30 minutes, give every mice left hind foot pad portion direction, naked joint subcutaneous injection carrageenin (concentration is 1.0% suspension) 0.005ml respectively, cause edema.Before administration with administration after different time, measure left and right, 0.5cm place limb diameter (amplifying about 6 times) under the naked joint of left hind with photoelectricity projector, before after administration, diameter deducts administration, diameter is as swelling.Average and to compare with matched group, carry out statistical test, the results are shown in Table 3, result shows that sufficient the swelling of mice that medicine on Carrageenan of the present invention causes has obviously inhibitory action, on this model, the antiinflammatory action of medicine of the present invention shows as the edema degree alleviating the aseptic inflammation caused by carrageenin, postpone the generation of inflammation and promote the disappearing of inflammation, its antiinflammatory action and hydrogenation can the loose weak effect of color few.
Table 3
*P＜0.05，**P＜0.01，***P＜0.001。
clinical data:
1.1 MethodsThe cases enrolled diagnostic criterias
Adopt ARA diagnostic criteria in 1987.
Rheumatoid arthritis feelings activity standard:
(1) moderate during rest pain;
(2) morning, the stiff time was more than or equal to 1 hour;
More than (3) three arthroncuss;
(4) articular pain is more than or equal to 5 joints;
(5) ESR is greater than 28mm/hr.
Meet above 4 namely diagnosable.
1.2 physical data
All selected patients are divided into two groups at random, treatment group 135 example, wherein male patient 55 example, female patient 80 example; Matched group 80 example, wherein male patient 22 example, female patient 58 example.
1.3 Therapeutic Method
So the monthly inactive slow-acting drug of patient the first two or glucocorticoid, constant before and after non-steroid antiinflammatory drug treatment.Treatment group takes granule prepared by the embodiment of the present invention 3, each 10g, one day three times; Matched group takes leflunomide, methotrexate and folic acid, leflunomide once-a-day, a two panels, methotrexate once-a-day, an a slice, weekly, a two panels, starts to take the 3rd day of taking methotrexate folic acid; The course for the treatment of of two groups is 3 months.
1.4 evaluation of clinical curative effect standards
At the end of the course for the treatment of, to joint swelling index, articular pain index, morning is stiff, grip, and ESR, RF examine, and the improvement degree of every index is calculated as follows:
Value × 100% before (before treatment the rear value of value-treatment)/treatment;
ESR calculates:
(before treatment the rear value of value-treatment)/(before treatment value-normal value) × 100%;
(male normal value is less than or equal to 15mm/hr, and female is less than or equal to 20mm/hr)
Curative effect classification:
Calculate the improvement percent of indices, addition calculates it and on average improves percent to judge curative effect.
Effective: than before treatment after treatment, improvement rate >=70%.
Effective: than before treatment after treatment, 50%≤improvement rate < 70%.
Improve: than before treatment after treatment, 30%≤improvement rate < 50%.
Invalid: than before treatment after treatment, improvement rate < 30%.
Total effective rate=obvious effective rate+effective percentage+improvement rate.
1.5 therapeutic outcome
Two groups of therapeutic outcomes are as shown in table 4.
Table 4 liang group therapeutic effect contrast
From the above results, medicine of the present invention is obviously better than the combined therapy of leflunomide, methotrexate and folic acid in the curative effect for the treatment of rheumatoid arthritis.
Although above-described embodiment illustrate and describes the present invention, for the ordinary skill in the art, be appreciated that and can carry out multiple change, amendment, replacement and modification to these embodiments without departing from the principles and spirit of the present invention, scope of the present invention is by claims and equivalents thereof.
Claims (10)
1. be used for the treatment of a Chinese medicine for rheumatoid arthritis, it is characterized in that: described Chinese medicine is made up of the raw material of following weight portion: Agkistrodon 30-120, Radix Angelicae Pubescentis 100-200, Radix Angelicae Sinensis 110-180, Flos Carthami 130-220, Rhizoma Homalomenae 90-210, Scorpio 80-150, Rhizoma Paridis 100-180, Hippocampus 50-100, Rhizoma Coptidis 80-170, Rhizoma Cibotii 70-150, Fructus Xanthii 70-160, Radix Bupleuri 40-120, Ramulus Cinnamomi 70-170, Cornu Bubali 20-60, Indigo Naturalis 30-80, Radix Aucklandiae 40-80, Folium Artemisiae Argyi 50-90.
2. be used for the treatment of the Chinese medicine of rheumatoid arthritis as claimed in claim 1, it is characterized in that: described Chinese medicine is made up of the raw material of following weight portion: Agkistrodon 30-100, Radix Angelicae Pubescentis 120-200, Radix Angelicae Sinensis 120-180, Flos Carthami 130-200, Rhizoma Homalomenae 90-190, Scorpio 90-150, Rhizoma Paridis 120-180, Hippocampus 60-100, Rhizoma Coptidis 100-170, Rhizoma Cibotii 80-150, Fructus Xanthii 70-130, Radix Bupleuri 60-120, Ramulus Cinnamomi 70-150, Cornu Bubali 30-60, Indigo Naturalis 30-70, Radix Aucklandiae 40-70, Folium Artemisiae Argyi 60-90.
3. be used for the treatment of the Chinese medicine of rheumatoid arthritis as claimed in claim 2, it is characterized in that: described Chinese medicine is made up of the raw material of following weight portion: Agkistrodon 30, Radix Angelicae Pubescentis 200, Radix Angelicae Sinensis 120, Flos Carthami 200, Rhizoma Homalomenae 90, Scorpio 150, Rhizoma Paridis 120, Hippocampus 100, Rhizoma Coptidis 100, Rhizoma Cibotii 150, Fructus Xanthii 70, Radix Bupleuri 120, Ramulus Cinnamomi 70, Cornu Bubali 60, Indigo Naturalis 30, the Radix Aucklandiae 70, Folium Artemisiae Argyi 60.
4. be used for the treatment of the Chinese medicine of rheumatoid arthritis as claimed in claim 2, it is characterized in that: described Chinese medicine is made up of the raw material of following weight portion: Agkistrodon 100, Radix Angelicae Pubescentis 120, Radix Angelicae Sinensis 180, Flos Carthami 130, Rhizoma Homalomenae 190, Scorpio 90, Rhizoma Paridis 180, Hippocampus 60, Rhizoma Coptidis 170, Rhizoma Cibotii 80, Fructus Xanthii 130, Radix Bupleuri 60, Ramulus Cinnamomi 150, Cornu Bubali 30, Indigo Naturalis 70, the Radix Aucklandiae 40, Folium Artemisiae Argyi 90.
5. be used for the treatment of the Chinese medicine of rheumatoid arthritis as claimed in claim 2, it is characterized in that: described Chinese medicine is made up of the raw material of following weight portion: Agkistrodon 60, Radix Angelicae Pubescentis 150, Radix Angelicae Sinensis 160, Flos Carthami 180, Rhizoma Homalomenae 130, Scorpio 100, Rhizoma Paridis 140, Hippocampus 70, Rhizoma Coptidis 120, Rhizoma Cibotii 100, Fructus Xanthii 110, Radix Bupleuri 80, Ramulus Cinnamomi 110, Cornu Bubali 40, Indigo Naturalis 50, the Radix Aucklandiae 60, Folium Artemisiae Argyi 70.
6. the Chinese medicine being used for the treatment of rheumatoid arthritis as described in any one of claim 1-5, is characterized in that: the dosage form of described Chinese medicine is decoction, tablet, capsule, injection or granule.
7. prepare the method being used for the treatment of the Chinese medicine of rheumatoid arthritis as described in any one of claim 1-5, it is characterized in that: the concrete steps of described method are as follows:
(1) first take traditional Chinese medicinal material raw materials by proportioning, then put into Chinese medicine grinder respectively and pulverize, grinding and sieving;
(2) fine drug powder of the Agkistrodon of step (1) being prepared, Radix Angelicae Pubescentis, Flos Carthami, Rhizoma Homalomenae, Scorpio, Rhizoma Paridis, Hippocampus, Fructus Xanthii, Ramulus Cinnamomi, Cornu Bubali, Indigo Naturalis, the Radix Aucklandiae and Folium Artemisiae Argyi adds in reactor, add the dehydrated alcohol of 5-15 times amount, heating and refluxing extraction 3-7 hour, extracting solution is collected after cooling, and then in reactor, add the water of 2-7 times amount, heating and refluxing extraction 1-4 hour, collect extracting solution after cooling, then merge the extracting solution of twice, leave standstill and obtain supernatant;
(3) at supernatant heating being concentrated into 50 DEG C, relative density is 1.10-1.20, obtains thick paste;
(4) in thick paste, add the fine drug powder of Radix Angelicae Sinensis, Rhizoma Cibotii, Radix Bupleuri and Rhizoma Coptidis, then drying obtains dry extract;
(5) carried out by dry extract pulverizing, sieving, then add adjuvant, mixing, makes required dosage form according to a conventional method.
8. be used for the treatment of the preparation method of the Chinese medicine of rheumatoid arthritis as claimed in claim 7, it is characterized in that: in step (1), medicine crosses 200 mesh sieves after pulverizing.
9. be used for the treatment of the preparation method of the Chinese medicine of rheumatoid arthritis as claimed in claim 7, it is characterized in that: in step (2), add the dehydrated alcohol of 10 times amount, heating and refluxing extraction 5 hours.
10. be used for the treatment of the preparation method of the Chinese medicine of rheumatoid arthritis as claimed in claim 7, it is characterized in that: in step (2), add the water of 5 times amount, heating and refluxing extraction 3 hours; In step (3), at heating is concentrated into 50 DEG C, relative density is 1.15.
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