CN1216634C - Medicinal composition for treating pain - Google Patents
Medicinal composition for treating pain Download PDFInfo
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- CN1216634C CN1216634C CN 200410034162 CN200410034162A CN1216634C CN 1216634 C CN1216634 C CN 1216634C CN 200410034162 CN200410034162 CN 200410034162 CN 200410034162 A CN200410034162 A CN 200410034162A CN 1216634 C CN1216634 C CN 1216634C
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Landscapes
- Medicines Containing Plant Substances (AREA)
Abstract
The present invention relates to a medicine composition which uses a pure natural plant medical material as a main medicinal component and has the efficiency of wind expelling, dehumidification, cold dissipation, channel dredging, phlegmasia resistance, swelling elimination and analgesia. The medicine composition of the present invention is prepared into a medicine from the raw materials of the following proportion by weight: 100 to 2100 parts by weight of caulis mahoniae, 100 to 2100 parts by weight of asiatic toddalia root, 100 to 2100 parts by weight of adnate elder herb, 50 to 1500 parts by weight of erythrina bark, 80 to 1800 parts by weight of herba siegesbeckiae, 4 to 100 parts by weight of lunt flower root and 10 to 700 parts by weight of common achyranthes herb. The medicine of the present invention has the main treatment functions of wind expelling, dehumidification, cold dissipation and channel dredging. The medicine composition is used for cold, moisture paralysis, arthralgia, adverse bending and stretching, lumbar muscle strain and external wound waist and leg pain.
Description
Technical field
The present invention relates to a kind of is the pharmaceutical composition with expelling wind and removing dampness, cold expelling collateral dredging, antiinflammatory, detumescence and analgesia effect of main medicinal ingredient with the pure natural plant medical material.
Technical background is true
Motherland's medical science is thought, arthromyodynias such as rheumatic arthritis, rheumatoid arthritis, clinical condition see that joint, skin, bones and muscles pain, swelling are stiff, and numbness is weighing, and joint stuffiness arthroncus etc. are human feeling's wind, cold, wet, disease that hot several pathogens cause.
Chinese patent application 01128863.9 (publication number: 1404850) disclose a kind of " anti-inflammatory pain-releaving and swelling-diminishing external-use medicine ", it is with Radix Arnebiae (Radix Lithospermi), Bulbus Fritillariae Cirrhosae, Semen Strychni, Flos Carthami, Radix Cyathulae, Rhizoma Corydalis, Sanguis Draxonis, Caulis Clematidis Armandii, catechu, Radix Aconiti, Pseudobulbus Cremastrae Seu Pleiones, the Rhizoma Pinelliae, Radix Aconiti Kusnezoffii, Taraxacum, Radix Angelicae Sinensis, Lignum Sappan, Rhizoma Arisaematis, Caulis Mahoniae, Fructus Piperis Longi, Caulis Spatholobi is the external-use drug form that raw material is made, be mainly used in treatment because of tumor, whole body that cancer etc. cause or local edema, especially to the difficult patient with advanced cancer of taking medicine, the unique curative effect that more can show its inner disease outer treat, it can eliminate patient's edema in a short time, and its effective percentage reaches more than 96%.It also can be used for treating swelling and ache that tumor, rheumatism, traumatic injury, scapulohumeral periarthritis, arthritis, lumbago and backache, breast stomachache, bruise, chronic appendicitis, cyclomastopathy, gastrointestinal tract pain, weakness pain, gallbladder renal colic and a variety of causes cause in addition.Said medicine is a medicine for external use, and certain limitation is arranged, and seeks valuable clue from traditional medicine, and increasing treatment means is a kind of important channel.
Summary of the invention
The objective of the invention is to propose a kind of pharmaceutical composition that various pain is had better therapeutical effect.
The pharmaceutical composition of treatment pain of the present invention is the medicament of being made by the following weight proportion raw material: Caulis Mahoniae 100-2100, Radix Toddaliae Asiaticae 100-2100, Herba Sambuci Adnatae 100-2100, Cortex erythrinae 50-1500, Herba Siegesbeckiae 80-1800, colguhoumia root 4-100, Radix achyranthis asperae (Herba Achyranthis Asperae) 10-700.
The rule of treatment of the Dai nationality's medical science: not enough person supplies, and the person of exaggerating removes it; Cold type of pain person controls it with " refined emperor " (medicine of a warm nature), and the burning pain person controls it with " refined English " (cool, flat, cold) medicine, so stand out, mend " tower is muttered " and remove the logical blood of wind, and the method for treatment of blood road dispersing cold for relieving pain, this pharmaceutical composition can effectively be resisted virulence factor; Improve the joint set microcirculation, recover the normal function in joint; Reach aim of alleviating pain when recovering the cartilaginous tissue cell injury.And can recover the body tissue cells injury.The present invention be one group according to Dai Nationality's medical knowledge opinion prescription, and, extract its active ingredient, the preparation of the taking convenience that develops according to the nature and flavor characteristics of each herbal medicine.
Shang Shu Herba Siegesbeckiae is composite family Zhi Wu Herba Siegesbeckiae Siegesbeckia orientalis L, or the dry aerial parts of siegesbeckia glabrescens Makino grass Siegesbeckia glabrescens Madino.Main Han darutin-bitter (Darutin-bitter) and alkaloid, Dehong the Dai nationality claims " the vexed public affairs of tooth ", free translation: KONGXINCAO, traditional drugs is controlled dysentery with experience, and anasarca is mingled with sandstone in the urine.The Simao Diqu national folk claims the pig ear leaf, function relaxing muscles and tendons and activating QI and blood in the collateral, the suppressing the hyperactive liver of calming the nerves.Lijiang Prefecture's national folk claims Herba Senecionis Oldhamiani, function wind-damp dispelling, relieving rigidity of muscles and joints.Mountain of papers area national folk claims sticky dish, the function expelling wind and removing dampness, and pain relieving is calmed the nerves." the southern regions of the Yunnan Province book on Chinese herbal medicine 》 Cheng Herba Siegesbeckiae, bitter in the mouth, cold nature, slightly poisonous, control all rheumatism, have another name called Folium Microcoris paniculatae, function relaxing muscles and tendons and activating QI and blood in the collateral, the wind pain relieving of loosing.Radix Toddaliae Asiaticae is the dry root of rutaceae Radix Toddaliae Asiaticae Toddalia asiatica Lam..Mainly contain chelerythrine (Chelerythrine, Toddaline), dihydrochelerythrine (Dihydrochelerythrine, Toddaline) .beta.-fagarine (Sknmmianine), berberine (Berberine), Xishuangbannadaizu claims " pressing rattan "; The Simao Diqu national folk claims to sting three and adds, function reunion of bone, dissipating blood stasis for subsidence of swelling.Qujing Prefecture's national folk claims Radix Zanthoxyli Spinifolii, function tendons relaxing and meridians dredging, promoting blood circulation to remove blood stasis.Mountain of papers area national folk claims the small stream green pepper, function heat-clearing and toxic substances removing, hemostatic analgesia.Area, Red River district national folk claims wild wooden green pepper, function stasis-dispelling and pain-killing, hemostasis.Yuxi Prefecture's national folk claims to see that blood is anxious, the function expelling wind and removing dampness, and dredge the meridian passage induces sweat.Area, Kunming national folk claims to sting Folium Eriobotryae, function blood stasis dispelling, regulating menstruation, hemostasis, analgesia.In addition, Lincang Prefecture's national folk claims little lattice rattan; Baoshan Prefecture's national folk claims the blood caput, walks muscle and buys etc.Colguhoumia root is the dry root of Celastraceae plant Tripterygium hypoglaucum Tripterygiumhypoglaucum (Levl.) Hutch..Dehong the Dai nationality claims colguhoumia root, function eliminating blood stasis and smoothing collaterals, synthetism.The Simao Diqu national folk claims ZIJINTENG, function relaxing muscles and tendons and activating QI and blood in the collateral, dissipating blood stasis hemostasis.Area, Red River national folk claims Cortex tripterygii hypoglauci radicis, acrid in the mouth, and hardship, warm in nature, poisonous; Control bones and muscles pain, rheumatism and arthritis, apathy.Have another name called to fall the hair grass, function connects muscle symplectic bone, eliminating blood stasis and smoothing collaterals.Herba Sambuci Adnatae is the dry aerial parts of caprifoliaceae plant Herba Sambuci Adnatae Sambucus adnata Wall.Dehong the Dai nationality claims " tooth is reined in Jie " (transliteration), function reunion of fractured tendons and bones, promoting blood circulation by removing wind.The red blood Folium illicii Lanceolati of family's title among the people sends out in the Qujing Prefecture, and function is dispeled the wind, diuretic, synthetism.Lijiang Prefecture's national folk claims the blood stem or leaf of cattail, and the function expelling wind and removing dampness is enriched blood, invigorated blood circulation, diuresis." Yulong's book on Chinese herbal medicine " claims Caulis seu Radix Schisandrae Henryi.Area, Red River national folk claims showy reiolaena root-bark; Baoshan Prefecture's national folk claims big blood grass; Area, Dali national folk claims the blood vessel grass; The Margarita of being called fiber crops are also arranged, all as expelling wind and removing dampness, the antipruritic usefulness of dissipating blood stasis.Cortex erythrinae is the dry peel of stem of leguminous plant arbor perverse paulownia Erythrinaarborescens Roxb. or erythrina indica E.variegata var.orientalis (L) Merr..Mainly contain erythraline (Erythraline), aminoacid and organic benzene, Dehong the Dai nationality claims " burying the winter " (transliteration), free translation: erythrina indica, effect is dispeled the wind, removing obstruction in the collateral to relieve pain.Area, Kunming national folk claims Erythrina arborescens Roxb., the function expelling wind and removing dampness." Yulong's book on Chinese herbal medicine " is called Firmiana platanifolia (Linn. f.) Marsili; The parrot of being called flower is arranged, and imperial tail is all made treatment of arthritis and promoting collateral and channels, and the synthetism hemostasis is used.Caulis Mahoniae is the dry stem of Berberidaceae plant Mahonia bealei (Fort.) Carr. Mahonia bealei (Fort.) carr. or mahonia fortuneiFedde M.fortunei (Lindl.) Fedde.Mainly contain berberine.Berbamine (Shengbaian Pian), jateorhizine (Jatrorrhizine), palmatine (Palmatine) and oxyacanthine (Oxyacanthine), Dehong the Dai nationality claims: Xien do ham, transliteration: awake bucket is cried out, is buried to foolish; The function heat-clearing and toxic substances removing, anti-inflammtory anti-dysentery; Cure mainly diseases such as calentura, pneumonia, diarrhoea, dysentery; Lijiang Prefecture's national folk is called Mahonia fortunei (Lindl.)Fedde, nature and flavor hardship, cold, and the function heat clearing away, YIN nourishing makes eye bright.Mountain of papers area national folk is called Radix Berberidis, and nature and flavor are bitter cool, function clearing heat for detumescence, nourishing the lung to arrest cough.Blood pressure lowering.Qujing Prefecture's national folk claims Radix Berberidis anhweiensis, nature and flavor bitter cold, function heat-clearing and toxic substances removing, anti-inflammation and sterilization, cough-relieving.Yuxi Prefecture's national folk is called big Rhizoma Coptidis, nature and flavor bitter cold, function heat clearing and inflammation relieving, tonifying the lung gas, ebb heat.Area, Red River national folk claims anistree thorn, nature and flavor bitter cold, function heat clearing and inflammation relieving, dampness removing and diarrhea-relieving.Radix achyranthis asperae (Herba Achyranthis Asperae) has another name called Radix Achyranthis, is the dry herb of Herba Amaranthi tricoloris large bamboo hat with a conical crown and broad brim plant Radix achyranthis asperae (Herba Achyranthis Asperae) Achyranthesasperl..State, Xishuangbanna the Dai nationality: " the no child in tooth bosom " " cherishing deaf " (transliteration), free translation: Serpentis stem grass for ethnic drug commonly used in Dai Nationality's medicine, is used for menoxenia, difficult labour, weak night sweat.Dehong the Dai nationality claims " tooth sea ", the function heat clearing away, and relieving stranguria by diuresis, Lijiang Prefecture's national folk is as blood circulation promoting and blood stasis dispelling, dredge the meridian passage medicine.Yuxi Prefecture's national folk claims the agnail flower, Red Radix Achyranthis Bidentatae, and as clearing away heat and promoting diuresis, activating collateral flow, medicine for rheumatism.The Simao Diqu national folk claims limit, garden Radix Achyranthis Bidentatae; As blood circulation promoting and blood stasis dispelling, the removing damp-heat medicine." the southern regions of the Yunnan Province book on Chinese herbal medicine " claims Du Radix Achyranthis Bidentatae, the chicken artemisiifolia, and it is swollen bitterly to be used for the treatment of furuncle.
China's " four big nationality's medicine " (hides, cover, dimension, the Dai Nationality) one of the doctor Dai Nationality of Dai Nationality medicine, has the long history in more than 2,000 year, the Dai nationality's medical science is thought, the generation of above-mentioned disease then is because interior " four the towers " (wind of human body, fire, water, soil), " five accumulate " (color, know, be subjected to, think, functional disorder OK), " tower phenanthrene " (fire), " hold together " (pathogenic wind) insufficiency of function, experience extraneous " Pa Ya holds together " (pathogenic wind-dampness) in addition, interior foreign minister and intrusion human body, the retardance QI-blood circulation, " tower is muttered " (water) is obstructed, " tower bell " (soil) is not loose, the water food more can't move, and goes here and there in the whole body so ailment said due to cold or exposure is held the assorted wet evil stream of water under the arm, and it is obstructed that QI and blood is blocked more, stagnation of QI and blood may bring about pain, sending out is primary disease.In order to treat this class disease, Dai Nationality doctor is with " four towers " cube, select corresponding medicine and control it, Radix Toddaliae Asiaticae in the side, Herba Sambuci Adnatae red complexion warm in nature and go into " tower is muttered " (water one blood), the disease of primary disease is mainly at water blood, and the not all right then pain of water blood is so entry is wet mutually and directly for two medicines, make the current pain of water blood from ending, be principal agent; Colguhoumia root, Cortex erythrinae are warm in nature, the gas suffering is also gone into water tower, Shang Ta, has Wen Huashui blood, the merit that logical blood is invigorated blood circulation, the evil strongly fragrant heat-transformation of a specified duration of specially curing the disease, the disease of redness and swelling of joints, can suppress the side effect of principal agent wound hot in nature " tower is muttered " (water one blood) again, its using medicines of both cold and hot natures simultaneously has the merit of leveling " four towers ", but because we have very strong blood circulation and channel invigorating, the power of blood-activating analgetic, and disease such as can control.
Medicine major function of the present invention cures mainly and is expelling wind and removing dampness, cold expelling collateral dredging.Be used for anemofrigid-damp arthralgia, card is seen: arthralgia, joint stuffiness, lumbar muscle strain, traumatic lumbago and skelalgia.The doctor of the Dai Nationality is: mend native beneficial water, dispelling wind and removing obstruction in the collateral.Be used for rheumatic arthritis and lumbar muscle strain, diseases such as traumatic lumbago and skelalgia.
Pharmaceutical dosage form of the present invention is the above a oral formulations of pharmaceutics.The oral liquid of making through conventional technology by raw material of the present invention and corresponding medicinal adjuvant, capsule, tablet, granule, powder, soft capsule, liniment, tincture, pill etc.Its consumption is per day for adults 2.4-6.8 gram.
The pharmacodynamics test of pharmaceutical composition of the present invention:
Experiment material:
1. animal: the ICR mice, male and female are usefulness all, provides (No. the 2000023rd, the real moving card word in Yunnan) by Natural Medicine Inst., Yunan Baiyao Group.The SD rat, male and female are usefulness all, provides (No. the 003rd, the moving pipe of middle section) by Chinese Academy of Sciences's Shanghai Experimental Animal Center.
2. animal and reagent: this pharmaceutical composition spice extractum, every gram equal 5 gram crude drugs, are provided by Benshan Pharmaceutical Co., Ltd., Yunan Prov.YUNNAN BAIYAO, specification: the 4g/ bottle, lot number: 20001106, produce by joint stock company limited of YUNNAN BAIYAO group.Dimethylbenzene is available from Wuhan organic synthesis factory, specification 500mL, analytical pure.Carrageenin is provided by institute of materia medica, Liaoning Province.
3. instrument: SEN-7203 type electric stimulating instrument, Japanese Nibon Kohden company product.
Method and result:
One, the antiinflammatory action of this pharmaceutical composition
1. on Carrageenan causes the influence of rat paw edema
The SD rat, body weight 216 ± 20g, male and female are usefulness all, divides 5 groups at random, and promptly equal-volume normal saline group, this pharmaceutical composition 0.5,1,2g/kg organize, YUNNAN BAIYAO 0.8g/kg group.The equal gastric infusion of each treated animal, 10ml/kg 1 time/d, is total to 7d.Behind last administration 60min, rat one parapodum plantar subcutaneous injection 1% carrageenin suspension 0.1ml, the side subcutaneous injection compares with the volume normal saline in addition.Measure sufficient sole of the foot change in volume (capillary tube amplifying method, silver is filled with water in the propaganda material), per hour measure once to 6h.
The result shows, the obviously swelling of the right foot of control rats, and thickness increases, and two foots differ greatly; Sufficient volume difference about the YUNNAN BAIYAO of this pharmaceutical composition of 2g/kg and 0.8g/kg all reduces very significantly acts on sustainable 6h above (the normal saline group of P＜0.01 and equi-time point relatively); Sufficient volume difference about this pharmaceutical composition of 1g/kg also reduces very significantly, the sustainable 4h of drug effect (the normal saline group of P＜0.01 and equi-time point is relatively); 0.5g/kg this pharmaceutical composition then do not have obvious minimizing foot swelling effect (the normal saline group of P＞0.05 and equi-time point relatively); The result shows that this pharmaceutical composition (be equivalent to clinical consumption 10 and 5 times) of height, middle dosage has very significantly antiinflammatory edema effect.
2. xylol causes the influence of mice auricle swelling
Male ICR mouse, body weight 25-28g is divided into 5 groups at random, and 10 every group, promptly equal-volume normal saline group, this pharmaceutical composition 0.5,1,2g/kg group and YUNNAN BAIYAO 0.8g/kg organize.Each group of test is pressed the 0.2mL/10g gastric infusion, and 1 time/d, continuous 5d.45min draws dimethylbenzene (0.03ml/ only) with micro sample adding appliance and drips in mouse right ear after the last administration, puts to death animal behind the 15min.Card punch with diameter 8mm is drawn materials along the punching of left and right sides auricle same area.Weigh respectively, with two auricle method of double differences values as swelling degree index.Compare the difference of administration group and matched group, and obtain the swelling degree.
Presentation of results, the obvious swelling thickness of normal saline group mouse right ear increases, and the two auricle method of double differences are bigger; This pharmaceutical composition of high dose is the same with YUNNAN BAIYAO, and resist inflammation on repercussive function is (P＜0.01vs normal saline group) very obviously, and middle dosage also has remarkable antiinflammatory action (P＜0.05vs normal saline group).
Two, the analgesic activity of this pharmaceutical composition
1. mice electrostimulation
Screen qualified mice: healthy ICR mice, body weight 18-25g, male and female half and half.Mice is put into holder,, be coated with, put stimulating electrode (being coated with 5% saline) in mouse tail with conducting resinl with 75% alcohol rub mouse tail.Stimulate with 10V, 1Hz, the capable square wave of the wide 10ms of ripple with electric stimulating instrument (model: SEN-7203, Japanese Nihon Kohden company product).Continued stimulus 3 times (each 5min at interval), 3 times the responder of all shouting is qualified animal.
Above-mentioned qualified mice is divided into 5 groups at random, and 20 every group, promptly normal saline group, 0.8g/kg YUNNAN BAIYAO group, this pharmaceutical composition 0.5,1 and 2g/kg organize.Animal 1 time/d, is total to 5d all with 0.2mL/10g body weight gastric infusion.In last administration 20,40,60 and 90min, repetitive stimulation Mus tail connects 2 times the person that do not shout respectively, and the expression medicine has analgesic activity, is calculated as follows analgesia percentage rate percentage rate:
Analgesia rate (5)=analgesia Mus number/total Mus number * 100
The result shows, electricity irritation is caused mouse tail pain, high, in this pharmaceutical compositions of low three kinds of dosage obvious analgesic activity is all arranged, and have tangible dose-effect relationship; During high dose, the sustainable 90min of its analgesic activity.YUNNAN BAIYAO also has remarkable analgesic activity.
2. mice hot plate method
It is the red copper cylinder that device is gushed in survey, places in 56 ℃ of waters bath with thermostatic control, and each test is no more than 60s.Licking metapedes with mice is the pain indicator reaction, selects the responsive mice of reaction.
Above-mentioned qualified mice, male and female are usefulness all, is divided into 5 groups at random, and 10 groups every group, promptly normal saline group, 0.8g/kg YUNNAN BAIYAO group, this pharmaceutical composition 0.5,1 and 2g/kg organize.45min behind the disposable gastric infusion puts into above-mentioned survey pain device, writes down the time (s) that administration front and back 45,60,90 and 120min mice lick metapedes respectively, calculates the also significance of comparable group differences.
The result shows, the pain reaction of thermic mice all had obvious prolongation with this pharmaceutical composition of g/kg and 2g/kg and YUNNAN BAIYAO lick the metapedes time, the sustainable 120min of drug effect; 0.5g/kg the time, then there is not obviously effect.
3. mice acetic acid twisting method
The ICR mice, body weight 20-24g, the male and female dual-purpose is divided into 5 groups at random, 10 every group.Normal saline group, 0.8g/kg YUNNAN BAIYAO group, this pharmaceutical composition 0.5,1 and 2g/kg group.Animal 1 time/d, is total to 5d all with 0.2mL/10g body weight gastric infusion.Behind last administration 1h, the equal lumbar injection 0.6% acetic acid 0.1mL/10g of each Mus.Observe the number of times that writhing response appears in interior each animal of 15min.
The result shows that this pharmaceutical composition of YUNNAN BAIYAO, 2g/kg and 1g/kg all reduces the mouse writhing number of times very significantly; 0.5g/kg this pharmaceutical composition then do not have remarkable effect.
Discuss and conclusion
This utility model is the result show, this pharmaceutical composition of high, middle dosage (be equivalent to clinical consumption 10 and 5 times) has the effect that unusual obvious suppression carrageenin causes rat paw edema, also significantly reduce the mice caused by dimethylbenzene xylene auricle edema simultaneously, and certain dose-effect relationship is arranged, disclose this product and have very significantly antiinflammatory edema effect.
In multiple pain reaction models such as electricity irritation Mus tail, mice hot plate method and acetic acid twisting method, this pharmaceutical composition high, middle dosage all shows very significant analgesia role, and has certain dose-effect relationship.
The result shows that this pharmaceutical composition has very significantly antiinflammatory, edema and analgesic activity.This result of the test provides the pharmacodynamics foundation for the clinical practice of this pharmaceutical composition.
The sick clinical verification of medicine composite for curing numbness of the present invention is summed up:
One, test objective
Observe the curative effect of this pharmaceutical composition of checking, and investigate its safety the syndrome of cold-dampness blocking collaterals in the numbness disease.
Two, physical data
According to the requirement of this pharmaceutical composition clinical trial plan, select to be in hospital respectively and the out-patient, test group 100 examples wherein, matched group 40 examples are mainly selected the arthritic patient of the turbid property of rheumatic arthritis and class wind.
Maximum 65 years old age of test group, minimal ages 23 years old, 46.78 years old mean age, at maximum 65 years old age of matched group, minimal ages 24 years old, is learned by statistics and is handled P＞0.05, there was no significant difference, tool comparability 41 years old mean age.
Three, case choice criteria
(1) diagnostic criteria
1. tcm diagnosis standard:
1. main clinical manifestation: position pain such as joint, muscle, muscles and bones, swelling, numbness is weighing, or bends
It is unfavorable etc. to stretch.
2. characteristics of incidence: how relevant with climate change.
3. sex age characteristics: good sending out in person between twenty and fifty, the women is more than the male.
4. physico-chemical examination: anti-" O " raises or erythrocyte sedimentation rate speeds.
2. differential diagnosis in tcm standard:
Syndrome of cold-dampness blocking collaterals: the limbs joint pain and swelling, local fear of cold, color of the leather are not red, and that touches is not hot, pain increase in intensity under coldness, pain alleviated while getting warmth, enlarged tongue, matter is light dark, the greasy in vain or whiten of tongue, stringy and tense pulse or string are slow.
3. Western medicine diagnose standard:
(1) rheumatic arthritis
1. clinical manifestation: the streptococcal infection history is arranged, and acute stage, can have multiple and the migration joint aches more.
2. laboratory examination: anti-" O " more than 500 units or erythrocyte sedimentation rate speed.
3. X skiagram: no bone damage.
(2) rheumatoid arthritis
1. morning deadlock at least 1 hour, continue more than 6 weeks.
2. the arthroncus more than 3 or 3 continues more than 6 weeks at least.
3. carpal joint, metacarpal joint or more than 6 weeks of proximal interphalangeal joint swelling.
4. symmetry arthroncus.
5. subcutaneous rheumatoid nodules.
6. the rheumatoid factor positive.
7. finger-joint X line changes confirmation.
4. include the case standard in
Allly meet the diagnosis of above-mentioned Chinese and western medicine, differential diagnosis in tcm belongs to cold-damp resistance network person, all can include the test case in.
5. get rid of the case standard
Though 1. be primary disease but take Western medicine or other drug for a long time, must stop using, otherwise should get rid of.
2. late deformity, the maimed person, disability person should get rid of.
3. gestation or women breast-feeding their children are to this medicine allergy sufferers under-18s or over-65s person the age.
4. merge serious primary disease such as cardiovascular, liver, kidney and hemopoietic system, psychotic.
5. do not meet the standard of including in, not medication in accordance with regulations can't be judged curative effect or data not umbra sound curative effect or safety judgement person.
Four, observation index:
(1) safety indexes
1. general health check-up project
2. routine blood test
3. the heart, liver, kidney function test, (doing part)
(2) curative effect index
1. clinical manifestation: pain such as joint, muscle, muscles and bones, swelling degree
2. function of joint active situation
3. General Symptoms: the cold and heat happiness is disliked, and the whole body is sleepy, diet etc.
4. the tongue arteries and veins changes
5. erythrocyte sedimentation rate
6. anti-" O "
7. rheumatoid factor
8. electrocardiogram
Five, clinical implementation scheme
(1) test method: adopt randomized blocks
(2) observe and contrast: test group 100 examples, matched group 40 examples
(3) control drug: FENGSHI YE
(4) usage and dosage:
This pharmaceutical composition: oral every day 3 times, 20ml early, noon 10ml, late 20ml.
FENGSHI YE: oral every day 3 times, each 15ml.
(5) course of treatment: 15 days.
Six, toxic and side effects is observed: note the toxic and side effects observation, and as toxic side effect, drug withdrawal immediately.
Seven, curative effect judging standard:
(1) clinical cure: symptom all disappears, and it is normal that functional activity recovers; Main doctor trained in Western medicine index is normal.
(2) produce effects: cardinal symptom disappears substantially or cardinal symptom disappears, and function of joint is recovered substantially, can participate in operate as normal and work, and the physico-chemical examination index is normal substantially.
(3) effective: cardinal symptom all disappears, and main function of joint is recovered substantially or had made marked progress, and can't take care of oneself transfers to and taking care of oneself, and perhaps loses work or work capacity and transfers to ability to work and recovering to some extent, and mainly the physico-chemical examination index makes moderate progress.
(4) invalid: and compare before the treatment, each side does not all have improvement.
Eight, result of the test
(1) the curative effect situation relatively
Two kinds of curative effect of disease are relatively learned by statistics and are handled, and there is significant difference rheumatic arthritis P＜0.05; Rheumatoid arthritis P＞0.05, there was no significant difference, but total obvious effective rate illustrates test group treatment rheumatic arthritis apparently higher than matched group, rheumatoid arthritis all has good curative effect very, and is especially more remarkable to the rheumatic arthritis effect.
Two groups of symptom curative effects are relatively learned by statistics and are handled, and there is significant difference arthralgia, cold and heat binomial symptom P＜0.05, arthroncus, functional activity binomial symptom P＞0.05, there was no significant difference.Illustrate that test group is alleviated arthralgia, symptoms of chill and fever effect is remarkable; Treatment arthroncus, functional activity symptom effect is close with matched group.
The tongue arteries and veins is relatively learned by statistics and is handled before and after the treatment of tongue arteries and veins situation, and all there is significant difference body of the tongue, tongue fur, pulse condition P＜0.05.Illustrate that test group has the effect that improves body of the tongue, tongue fur, pulse condition.
Routine blood test is relatively learned by statistics and is handled before and after the treatment of routine blood test comparative test group, WBC, and p＜0.05, there were significant differences, RBC, HB, P＞0.05, there was no significant difference.Illustrate that test group has certain effect to reducing leukocyte; Influence not obvious to erythrocyte, hemoglobin.
Anti-" O ", erythrocyte sedimentation rate, rheumatoid factor curative effect are relatively learned by statistics and are handled before and after the test group treatment, and there is significant difference anti-" O ", erythrocyte sedimentation rate P＜0.05; Rheumatoid factor P＞0.05, there was no significant difference illustrates that test group anti-to reducing " O ", erythrocyte sedimentation rate have certain effect, do not have influence to rheumatoid factor.
Electrocardiogram is relatively learned by statistics and is handled before and after the test group treatment, P＞0.05, and there was no significant difference illustrates that test group is not obvious to the electrocardiogram influence.
Hepatic and renal function is relatively learned by statistics and is handled before and after the test group treatment, P＞0.05, and there was no significant difference illustrates that test group do not have obvious influence to hepatic and renal function.
Result of the test shows: test group and matched group, total effects are relatively learned by statistics and are handled, and there is significant difference P＜0.05; The symptom curative effect is relatively learned by statistics and is handled, arthroncus cold and heat binomial symptom, and there is significant difference P＜0.05, arthralgia, functional activity binomial symptom P＞0.05, there was no significant difference; Tongue is relatively learned by statistics and is handled body of the tongue P＞0.05 before and after the test group treatment, there was no significant difference, there is significant difference tongue fur, pulse condition P＜0.05, and anti-" O ", erythrocyte sedimentation rate are relatively before and after the test group treatment, learn by statistics and handle, there is significant difference P＜0.05, and rheumatoid factor relatively, P＞0.05, there was no significant difference; Electrocardiogram is relatively learned by statistics and is handled P＞0.05, there was no significant difference before and after the test group treatment; Routine blood test is relatively learned by statistics and is handled before and after the test group treatment, WBC, and there is significant difference P＜0.05, RBC, HbP＞0.05, there was no significant difference; Hepatic and renal function is relatively learned by statistics and is handled P＞0.05, there was no significant difference before and after the test group treatment.
Nine, side effect is observed
Test group three examples, slight stomach discomfort appears in matched group two examples, disappears after the drug withdrawal.
Ten, discuss
(1) two group of patient distributes relatively from sex, age, the course of disease, and learn by statistics and handle, P＞0.05, there was no significant difference illustrates to have comparability.
(2) therapeutic outcome: total effects is relatively learned by statistics and is handled, and significant difference is arranged, and illustrates that the test group therapeutic effect obviously is better than matched group.
(3) the sick observation of curative effect of planting: two kinds of curative effect of disease are relatively learned by statistics and are handled rheumatic arthritis P＜0.05, and significant difference is arranged; Rheumatoid arthritis P＞0.05, there was no significant difference, but total obvious effective rate is apparently higher than matched group.Illustrate that two kinds of diseases of test group treatment all have better curative effect, especially more remarkable to the rheumatic arthritis effect.
(4) symptom observation of curative effect: two groups of symptom curative effects are relatively learned by statistics and are handled, arthralgia, and there is significant difference symptoms of chill and fever P＜0.05; Arthroncus, functional activity binomial symptom P＞0.05, there was no significant difference.Illustrate that test group is alleviated arthralgia, symptoms of chill and fever effect is remarkable; Alleviate arthralgia, the functional activity effect is close with matched group.
(5) the tongue pulse condition is observed: tongue pulse condition situation is relatively learned by statistics and is handled before and after the test group treatment, and all there is significant difference body of the tongue, tongue fur, pulse condition P＜0.05, illustrates that test group has positive effect to improving body of the tongue, tongue fur, pulse condition.
(6) anti-" O ", erythrocyte sedimentation rate rheumatoid factor are observed: anti-" O ", erythrocyte sedimentation rate, rheumatoid factor before and after the test group treatment, and to learn by statistics and handle, there is significant difference anti-" O ", erythrocyte sedimentation rate P＜0.05; Rheumatoid factor P＞0.05, there was no significant difference.Illustrate that test group anti-to improving " O ", erythrocyte sedimentation rate have positive effect, improve not obvious rheumatoid factor.
(7) routine blood test is observed: routine blood test is relatively learned by statistics and is handled before and after the test group treatment, WBC, and there is significant difference P＜0.05; RBC, Hb, P＞0.05, there was no significant difference.Illustrate that test group has certain effect to improving WBC, to RBC, Hb does not have obvious influence.
(8) electrocardiogram is observed: electrocardiogram is relatively learned by statistics and is handled P＞0.05, there was no significant difference before and after the test group treatment.Illustrate that test group do not have influence to electrocardiogram.
(9) hepatic and renal function is observed: hepatic and renal function is relatively learned by statistics and is handled P＞0.05, there was no significant difference before and after the test group treatment.Illustrate that test group do not have influence to hepatic and renal function, have safety.
Slight gastralgia appears in (ten) test group three examples during the matched group two routine patient treatments, disappear after the drug withdrawal, illustrates that test group and matched group all have untoward reaction by chance.
Conclusion: the syndrome of cold-dampness blocking collaterals of this medicine composite for curing numbness, easy to use through clinical trial, evident in efficacy, safe and reliable, be worth develop and spread to be used.
The specific embodiment
Embodiment 1:
Get Caulis Mahoniae 210g, Radix Toddaliae Asiaticae 210g, Herba Sambuci Adnatae 200g, Cortex erythrinae 150g, Herba Siegesbeckiae 180g, colguhoumia root 10g, Radix achyranthis asperae (Herba Achyranthis Asperae) 70g, above medical material decocts with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction left standstill, filter, filtrate is concentrated into the clear paste that relative density is 1.03 (50 ~ 60 ℃), standing sedimentation, the filtering precipitation adds Mel, 100g potassium sorbate 0.8g, adds water to ormal weight, mixing filters fill, sterilization promptly gets oral liquid.
Embodiment 2:
Get Caulis Mahoniae 1050g, Radix Toddaliae Asiaticae 1050g, Herba Sambuci Adnatae 1000g, Cortex erythrinae, 750g, Herba Siegesbeckiae 900g, colguhoumia root 50g, Radix achyranthis asperae (Herba Achyranthis Asperae) 350g, more than 7 flavor medical materials decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction filtered, filtrate is concentrated into the clear paste that relative density is 1.20 ~ 1.22 (55 ~ 65 ℃), drying is pulverized, and adds starch 4.5g, Pulvis Talci 150g, add magnesium stearate 0.5g, mixing incapsulates, promptly.
Embodiment 3:
Get Caulis Mahoniae 700g, Radix Toddaliae Asiaticae 1200g, Herba Sambuci Adnatae 900g, Cortex erythrinae 200g, Herba Siegesbeckiae 1300g, colguhoumia root 20g, Radix achyranthis asperae (Herba Achyranthis Asperae) 500g, more than 7 flavor medical materials decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.20 ~ 1.22 (55 ~ 65 ℃), dry, pulverize, add right amount of auxiliary materials, make granule, tabletting, promptly.
Embodiment 4:
Get Caulis Mahoniae 1200g, Radix Toddaliae Asiaticae 800g, Herba Sambuci Adnatae 500g, Cortex erythrinae 600g, Herba Siegesbeckiae 700g, colguhoumia root 40g, Radix achyranthis asperae (Herba Achyranthis Asperae) 200g, decoct with water collecting decoction, filter, filtrate concentrates, and after the concentrated solution cooling, adds right amount of auxiliary materials, make soft material, mix homogeneously, drying, packing, sterilization promptly gets the granule finished product.
Embodiment 5:
Repeat the proportioning raw materials example of embodiment 1, difference is that above seven flavor medicine material is ground into fine powder, sieves mixing.Every 100g powder adds refined honey 120 ~ 140g, makes big honeyed pills, promptly.
Claims (1)
1, a kind of pharmaceutical composition for the treatment of pain is characterized in that it being the oral formulations of being made by the following weight proportion raw material: Caulis Mahoniae 100-2100, Radix Toddaliae Asiaticae 100-2100, Herba Sambuci Adnatae 100-2100, Cortex erythrinae 50-1500, Herba Siegesbeckiae 80-1800, colguhoumia root 4-100, Radix achyranthis asperae (Herba Achyranthis Asperae) 10-700.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410034162 CN1216634C (en) | 2004-04-26 | 2004-04-26 | Medicinal composition for treating pain |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200410034162 CN1216634C (en) | 2004-04-26 | 2004-04-26 | Medicinal composition for treating pain |
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| CN1216634C true CN1216634C (en) | 2005-08-31 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RO120818B1 (en) | 2005-04-20 | 2006-08-30 | A. Voicu Victor | Medicament composition with analgesic, anti-inflammatory and decongesting action |
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