CN1970030A - Chinese medicine for treating rheumatoid arthritis, preparation method and application thereof - Google Patents
Chinese medicine for treating rheumatoid arthritis, preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a Chinese medicament for treating rheumatism which is prepared from Chinese medicinal herbs including dried rehmannia root, prepared rehmannia root, dipsacus root, prepared aconite root, pubescent angelica root, drynaria, cassia twig, epimeddium, and ledebouriella root, the dose forms include any pharmacologically acceptable oral medications. The invention also provides the process for preparing the Chinese medicament, especially the process for preparing capsules, mini-pills, soft capsules and dispersible tablets.
Description
Technical field
The present invention relates to technical field of Chinese medicines, in particular to a kind of Chinese medicine for the treatment of rheumatoid arthritis and its production and application.
Background technology
" rheumatoid arthritis " is the new name of disease of the traditional Chinese medical science that famous Traditional Chinese Medicine experts Jiao of China establishes one's virtue and proposed in 1981, be meant joint deformity, enlargement, stiff, Jinsuo roulade, be difficult to stretch arthromyodynia in the wrong, that sclerotin is impaired, rheumatoid arthritis is because human righteousness's deficiency, imbalance of YIN and YANG, internal organs are deficient, the invasion and attack of flesh table meridians wind-engaging, cold-damp pathogenic heat, or by wound, blood stasis, turbid mixed the stagnating of expectorant, making QI and blood meridian is that the pathogenic factor impatency is fallen ill, especially with deficiency of both the liver and kidney, pathogen invasion and attack, interior characteristics of giving up muscles and bones.Rheumatoid arthritis comprises a class disease that has arthralgia, distortion in the western medicine, as rheumatoid arthritis, ankylosing spondylitis, Kaschin-Beck disease, tuberculous arthritis etc., but sees so that rheumatoid arthritis more.Rheumatoid arthritis is except that having arthralgia, swelling, heavy and migration to scurry the total symptom of rheumatism numbness such as pain, and it is longer that it also has the course of disease, and it is heavy that pain shows as light night in daytime more, and pain is sent out in the bone.The lighter's joint deformity, sclerotin is impaired, and Jiang Zhi Curled contraction can not be bent and stretched, and weight person's limb function is limited, can't take care of oneself.
The rheumatoid arthritis chronic inflammatory disease is not limited only to joint and joint surrounding tissue, can be with organ and tissue system infringements such as the abarticular heart, lung, blood vessels.So this disease is a kind of disease that can make the serious harm health of people that the people disables, pain is continuous and is not healed unbearably during its morbidity, is called as " not dead cancer ".Western medicine does not have medicine preferably yet, and the first line medicine is nonsteroidal antiinflammatory and analgesic medicine (as diclofenac, indometacin, ibuprofen etc.) and second line medicine (chloroquine, sulfasalazine, penicillamine, auranofin) and 17-hydroxy-11-dehydrocorticosterone.These medicines can not reach radical cure to treatment of rheumatoid arthritis, and the course of disease that only can control rheumatoid arthritis is unlikely progress, have the function in protection joint, avoid the destruction or further destruction in joint.But these drug side effect incidence rate height lead to complications easily, use NSAID (non-steroidal anti-inflammatory drug) equally, and its rheumatoid arthritis complication is 2 times of other osteoarthritis.
At present, the medicine of various these type of diseases of treatment on the market, effect all is not very desirable.
Summary of the invention
The object of the present invention is to provide a kind of Chinese medicine for the treatment of rheumatoid arthritis, little, the taking convenience of determined curative effect, toxic and side effects of this Chinese medicine.
The present invention also provides this preparation method of Chinese medicine.
Chinese medicine of the present invention is prepared from by acceptable auxiliary on following weight parts proportion raw material and the pharmaceutics:
Radix Rehmanniae 160-280 Radix Rehmanniae Preparata 160-280 Radix Dipsaci 120-210
Radix Aconiti Lateralis Preparata 120-210 Radix Angelicae Pubescentis 80-140 Rhizoma Drynariae 120-210
Ramulus Cinnamomi 80-140 Herba Epimedii 120-210 Radix Saposhnikoviae 80-140
Radix Clematidis 120-210 Spina Gleditsiae 80-140 Os Caprae seu Ovis 160-280
Radix Paeoniae Alba 96-168 system Rhizoma Cibotii 120-210 Rhizoma Anemarrhenae 120-210
Herba Lycopodii 80-140 Flos Carthami 80-140.
The weight portion proportion optimization of above-mentioned raw materials:
Radix Rehmanniae 235.3 Radix Rehmanniaes Preparata 235.3 Radix Dipsacis 176.5
Radix Aconiti Lateralis Preparata 176.5 Radix Angelicae Pubescentiss 117.7 Rhizoma Drynariae 176.5
Ramulus Cinnamomi 117.7 Herba Epimedii 176.5 Radix Saposhnikoviaes 117.7
Radix Clematidis 176.5 Spina Gleditsiaes 117.7 Os Caprae seu Ovis 235.3
The Radix Paeoniae Alba 141.2 system Rhizoma Cibotii 176.5 Rhizoma Anemarrhenaes 176.5
Herba Lycopodii 117.7 Flos Carthamis 117.7.
The weight portion proportioning of above-mentioned raw materials is also preferred:
Radix Rehmanniae 170 Radix Rehmanniaes Preparata 180 Radix Dipsacis 130
Radix Aconiti Lateralis Preparata 130 Radix Angelicae Pubescentiss 140 Rhizoma Drynariae 140
Ramulus Cinnamomi 90 Herba Epimedii 130 Radix Saposhnikoviaes 100
Radix Clematidis 130 Spina Gleditsiaes 90 Os Caprae seu Ovis 170
The Radix Paeoniae Alba 105 system Rhizoma Cibotii 130 Rhizoma Anemarrhenaes 130
Herba Lycopodii 100 Flos Carthamis 100.
The weight portion proportioning of above-mentioned raw materials is also preferred:
Radix Rehmanniae 280 Radix Rehmanniaes Preparata 260 Radix Dipsacis 200
Radix Aconiti Lateralis Preparata 190 Radix Angelicae Pubescentiss 130 Rhizoma Drynariae 180
Ramulus Cinnamomi 140 Herba Epimedii 195 Radix Saposhnikoviaes 120
Radix Clematidis 190 Spina Gleditsiaes 125 Os Caprae seu Ovis 270
The Radix Paeoniae Alba 155 system Rhizoma Cibotii 195 Rhizoma Anemarrhenaes 200
Herba Lycopodii 120 Flos Carthamis 120.
The weight portion proportioning of above-mentioned raw materials is also preferred:
Radix Rehmanniae 180 Radix Rehmanniaes Preparata 160 Radix Dipsacis 150
Radix Aconiti Lateralis Preparata 130 Radix Angelicae Pubescentiss 140 Rhizoma Drynariae 200
Ramulus Cinnamomi 110 Herba Epimedii 190 Radix Saposhnikoviaes 130
Radix Clematidis 130 Spina Gleditsiaes 125 Os Caprae seu Ovis 260
The Radix Paeoniae Alba 150 system Rhizoma Cibotii 180 Rhizoma Anemarrhenaes 180
Herba Lycopodii 120 Flos Carthamis 120.
The weight portion proportioning of above-mentioned raw materials is also preferred:
Radix Rehmanniae 200 Radix Rehmanniaes Preparata 230 Radix Dipsacis 170
Radix Aconiti Lateralis Preparata 150 Radix Angelicae Pubescentiss 90 Rhizoma Drynariae 160
Ramulus Cinnamomi 120 Herba Epimedii 145 Radix Saposhnikoviaes 90
Radix Clematidis 170 Spina Gleditsiaes 85 Os Caprae seu Ovis 210
The Radix Paeoniae Alba 120 system Rhizoma Cibotii 210 Rhizoma Anemarrhenaes 120
Herba Lycopodii 140 Flos Carthamis 80.
Because rheumatoid arthritis is because of human righteousness's deficiency, imbalance of YIN and YANG, internal organs are deficient; the invasion and attack of flesh table meridians wind-engaging, cold-damp pathogenic heat; or by wound, blood stasis, turbid mixed the stagnating of expectorant, making QI and blood meridian is that the pathogenic factor impatency is fallen ill, especially with deficiency of both the liver and kidney, pathogen invasion and attack, interior characteristics of giving up muscles and bones.Face upward and bow with Radix Aconiti Lateralis Preparata, Rhizoma Drynariae, Herba Epimedii, Fructus Psoraleae, Os Caprae seu Ovis invigorating the liver and kidney, strong spinal column, bone and muscle strengthening, beneficial vigour, replenishing essence marrow, profit in the prescription of the present invention.Diffusing wind dehumidifying such as Radix Angelicae Pubescentis, Ramulus Cinnamomi, Radix Saposhnikoviae, Radix Clematidis, dredge the meridian passage are more used Spina Gleditsiae, Herba Lycopodii, promoting blood circulation to remove obstruction in the collateral such as Flos Carthami, and accessory drugs assistant in pain relieving eliminating impediment side is with flourish muscle and cloudy to make sun that nourishes blood such as the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, living Radix Rehmanniaes Preparata, and it is just dry worn-out to supervise other drug.Heresy is just taken into account in this way, coordination of potent and mild therapies, and to deficiency of the liver and kindey in the arthromyodynia, bridle muscles and bones is particularly appropriate in the pathogen.Its clinical practice is outer numbness body void, arthralgia, local enlargement, stiff deformity, joint stuffiness, rheumatoid arthritis, osteoarthritis, Kaschin-Beck disease, tuberculous arthritis etc.Curative effect is better.
Preparation of the present invention can be prepared into acceptable oral Pharmaceutical dosage forms on any pharmaceutics according to the common process of this area.Preferred tablet, granule, capsule, micropill, soft capsule or instant dispersible tablet.
Adjuvant among the present invention is an acceptable auxiliary on the pharmaceutics, for example starch, lactose, dextrin, betacyclodextrin, magnesium stearate, Pulvis Talci, aspartame, crosslinked polyethylene pyrrole Lip river alkane ketone, stevioside, micropowder silica gel, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, castor oil hydrogenated, sodium stearyl fumarate or PEG-6000 or carboxymethyl starch sodium etc.Preferred betacyclodextrin, dextrin, microcrystalline Cellulose.
Capsule of the present invention can be made by the method for being prepared as follows:
Get above ten seven flavor medicine materials, decoct with water twice, decocted 1-4 hour for the first time, decocted 1-4 hour for the second time.Collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.10-1.25 (50 ℃).Qinghuo reagent adds adjuvant granulates, the choosing grain, and filling is prepared into capsule, promptly.
Preparation of the present invention also can be made micropill by the method for being prepared as follows:
Get above ten seven flavor medicine materials, decoct with water twice, decocted 1-4 hour for the first time, decocted 1-4 hour for the second time.Collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.19-1.25 (50 ℃).Qinghuo reagent adds adjuvant, the preparation micropill, and drying, coating, capsule charge, promptly.
Soft capsule of the present invention can prepare as follows:
Get above ten seven flavor medicine materials, decoct with water 2-3 time, each 1-4 hour, collecting decoction, filter, filtrate is condensed into fluid extract, puts coldly, adds ethanol and makes the medicinal liquid concentration of alcohol reach 50%-80%, stand at low temperature 8-24 hour, get supernatant concentration to fluid extract, the spray drying powder that gets dry extract.This dried cream powder is added proper auxiliary materials or solvent gets content, with pellet press with content-filled, be pressed in the soft capsule shell, then by wash ball, drying, select ball, operation such as packing both the rheumatoid arthritis soft capsule.
Preparation of the present invention also can be made dispersible tablet by the method for being prepared as follows:
Get above ten seven flavor medicine materials, decoct with water 2-3 time, each 1-4 hour, collecting decoction filtered, concentrated filtrate is to fluid extract, put coldly, add ethanol and make the medicinal liquid concentration of alcohol reach 50%-75%, stand at low temperature 12-24 hour, get supernatant concentration to clear paste, gained clear paste and proper auxiliary materials are prepared into the rheumatoid arthritis dispersible tablet.
Preparation of the present invention indication clinically is invigorating the liver and kidney, bone and muscle strengthening, wind-damp dispelling, the meridian dredging.Be used for deficiency of the liver and kindey, rheumatism hinders the rheumatoid arthritis due to the network, and disease is seen muscle, arthralgia, local enlargement, and stiff deformity, joint stuffiness, soreness of the waist and knees, fear of cold is weak; Rheumatoid arthritis is seen above-mentioned card marquis person.Specifically can be used for treating rheumatoid arthritis, ankylosing spondylitis, knee osteoarthritis etc.
Rheumatoid arthritis capsule of the present invention is 0.40 gram/grain, during use, one time 6,3 times on the one.
Rheumatoid arthritis pellt capsule of the present invention is 0.55 gram/grain, during use, one time 5,3 times on the one.
Rheumatoid arthritis soft capsule of the present invention is 0.5 gram/grain, during use, one time 6,3 times on the one.
Rheumatoid arthritis dispersible tablet of the present invention is 0.5 gram/grain, during use, one time 6,3 times on the one.
The specific embodiment
Embodiment 1
Radix Rehmanniae 235.3 Radix Rehmanniaes Preparata 235.3 Radix Dipsacis 176.5
Radix Aconiti Lateralis Preparata 176.5 Radix Angelicae Pubescentiss 117.7 Rhizoma Drynariae 176.5
Ramulus Cinnamomi 117.7 Herba Epimedii 176.5 Radix Saposhnikoviaes 117.7
Radix Clematidis 176.5 Spina Gleditsiaes 117.7 Os Caprae seu Ovis 235.3
The Radix Paeoniae Alba 141.2 system Rhizoma Cibotii 176.5 Rhizoma Anemarrhenaes 176.5
Herba Lycopodii 117.7 Flos Carthamis 117.7.
Make Chinese medicine preparation according to a conventional method.
Embodiment 2
Radix Rehmanniae 170 Radix Rehmanniaes Preparata 180 Radix Dipsacis 130
Radix Aconiti Lateralis Preparata 130 Radix Angelicae Pubescentiss 140 Rhizoma Drynariae 140
Ramulus Cinnamomi 90 Herba Epimedii 130 Radix Saposhnikoviaes 100
Radix Clematidis 130 Spina Gleditsiaes 90 Os Caprae seu Ovis 170
The Radix Paeoniae Alba 105 system Rhizoma Cibotii 130 Rhizoma Anemarrhenaes 130
Herba Lycopodii 100 Flos Carthamis 100.
Preparation method is as follows:
Get above ten seven flavor medicine materials, decoct with water twice, decocted 2 hours for the first time, decocted 4 hours for the second time.Collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.10-1.25 (50 ℃).Qinghuo reagent adds the dextrin spray granulation, the choosing grain, and filling is prepared into capsule, promptly.
Embodiment 3 (raw material is in g)
Radix Rehmanniae 280 Radix Rehmanniaes Preparata 260 Radix Dipsacis 200
Radix Aconiti Lateralis Preparata 190 Radix Angelicae Pubescentiss 130 Rhizoma Drynariae 180
Ramulus Cinnamomi 140 Herba Epimedii 195 Radix Saposhnikoviaes 120
Radix Clematidis 190 Spina Gleditsiaes 125 Os Caprae seu Ovis 270
The Radix Paeoniae Alba 155 system Rhizoma Cibotii 195 Rhizoma Anemarrhenaes 200
Herba Lycopodii 120 Flos Carthamis 120
Preparation method is as follows:
Get above ten seven flavor medicine materials, decoct with water twice, decocted 2 hours for the first time, decocted 1 hour for the second time.Collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.10-1.25 (50 ℃).Qinghuo reagent adds dextrin, the preparation micropill, and drying, coating, capsule charge, promptly.
Embodiment 4 (raw material is in g)
Radix Rehmanniae 180 Radix Rehmanniaes Preparata 160 Radix Dipsacis 130
Radix Aconiti Lateralis Preparata 130 Radix Angelicae Pubescentiss 140 Rhizoma Drynariae 200
Ramulus Cinnamomi 110 Herba Epimedii 190 Radix Saposhnikoviaes 130
Radix Clematidis 130 Spina Gleditsiaes 125 Os Caprae seu Ovis 260
The Radix Paeoniae Alba 150 system Rhizoma Cibotii 180 Rhizoma Anemarrhenaes 180
Herba Lycopodii 120 Flos Carthamis 120.
Preparation method is as follows:
Get above ten seven flavor medicine materials, decoct with water 3 times, each 2 hours, collecting decoction filtered, filtrate is concentrated into the fluid extract that relative density is 1.20-1.30 (80 ℃), put coldly, add ethanol and make the medicinal liquid concentration of alcohol reach 50%-80%, stand at low temperature 12 hours, get supernatant concentration to clear paste, the spray drying powder that gets dry extract.Make soft capsule through conventional operation.
Embodiment 5 (raw material is in g)
Radix Rehmanniae 280 Radix Rehmanniaes Preparata 260 Radix Dipsacis 200
Radix Aconiti Lateralis Preparata 190 Radix Angelicae Pubescentiss 130 Rhizoma Drynariae 180
Ramulus Cinnamomi 140 Herba Epimedii 195 Radix Saposhnikoviaes 120
Radix Clematidis 190 Spina Gleditsiaes 125 Os Caprae seu Ovis 270
The Radix Paeoniae Alba 155 system Rhizoma Cibotii 195 Rhizoma Anemarrhenaes 200
Herba Lycopodii 120 Flos Carthamis 120
Preparation method is as follows:
Get above ten seven flavor medicine materials, decoct with water 3 times, each 2 hours, collecting decoction filtered, filtrate is concentrated into the clear paste that relative density is 1.20-1.30 (80 ℃), put coldly, add ethanol and make the medicinal liquid concentration of alcohol reach 50%-75%, stand at low temperature 18 hours, get supernatant concentration to clear paste, the gained clear paste is mixed with into the rheumatoid arthritis dispersible tablet with lactose, crosslinked polyethylene pyrrole Lip river alkane ketone with carboxymethyl starch sodium.
Embodiment 6 (raw material is in g)
Radix Rehmanniae 200 Radix Rehmanniaes Preparata 230 Radix Dipsacis 170
Radix Aconiti Lateralis Preparata 150 Radix Angelicae Pubescentiss 90 Rhizoma Drynariae 160
Ramulus Cinnamomi 120 Herba Epimedii 145 Radix Saposhnikoviaes 90
Radix Clematidis 170 Spina Gleditsiaes 85 Os Caprae seu Ovis 210
The Radix Paeoniae Alba 120 system Rhizoma Cibotii 210 Rhizoma Anemarrhenaes 120
Herba Lycopodii 140 Flos Carthamis 80.
Preparation method is as follows:
Get above ten seven flavor medicine materials, decoct with water twice, decocted 2 hours for the first time, decocted 4 hours for the second time.Collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.10-1.25 (50 ℃).Qinghuo reagent adds the dextrin spray granulation, the choosing grain, and filling is prepared into capsule, promptly.
Confirm that through clinical experiment Chinese medicine preparation of the present invention has significant curative effect to rheumatoid arthritis of the present invention, and toxic and side effects is little, taking convenience.Concrete experimental data is as follows:
Test the main pharmacodynamics research of WANGBI CHONGJI treatment rheumatoid arthritis
Test two rheumatoid arthritis sheet Pharmacodynamic test of active extract
Test three wangbi granules III phase clinical experiment final reports
Test four rheumatoid arthritis sheet III phase clinical experiment final reports
The main pharmacodynamics research of WANGBI CHONGJI treatment rheumatoid arthritis
WANGBI CHONGJI is the Chinese patent medicine of the treatment rheumatoid arthritis of Benxi, Liaoning pharmacy three factories and association of traditional Chinese medicine's cooperation research and development, and 85 years production codes that got the Green Light are for the protection of application Chinese patent medicine kind reaches the action effect of propagating this medicine better to the patient.This paper has made following pharmacodynamic study with WANGBI CHONGJI.
One, experiment material:
(1) medicine and reagent: WANGBI CHONGJI is provided by Benxi, Liaoning pharmacy three factories, and cattle II Collagen Type VI is produced by Sigma company.Prednisone, cortisone are homemade.2, the 4-dinitrochlorobenzene is homemade.Ibuprofen, Sino-America Tianjin Shike Pharmaceutical Co., Ltd. produces.Hydrocortisone is homemade.
(2) animal: white mice, Switzerland's kind, body weight 18-22 gram, male and female half and half.Rat Wister system, body weight 160 ± 20 grams, male and female half and half are provided by Chinese Academy of Medical Sciences's animal center, and Cavia porcellus 350 ± 40 grams are provided by Capital University of Medical Sciences animal feeding field.
Two, method and result:
(1) to the treatment of experimental arthritis:
1, cattle II Collagen Type VI is brought out the effect of rat arthritis
Get 50 of rats, be divided into five groups by weight average: 1. matched group 2. the ibuprofen group 3. the WANGBI CHONGJI heavy dose organize 4. in the WANGBI CHONGJI 5. WANGBI CHONGJI small dose group of dosage group.Under the rat etherization, adding 0.1 milliliter of Freund ' s Freund's complete adjuvant (include fast knot nuclear bacillus 0.25 milligram) with cattle II Collagen Type VI 400ug is injected in the left hind foot pad injection collagen and adds adjuvant and began administration the same day, Chinese medicine WANGBI CHONGJI 28 days, Western medicine ibuprofen 21 days, water matched group feedwater 28 days.Before the injection and injection back was measured left and right sides toes volume respectively once in 5,10,15,18,21,24,28,34 days.
The toes swelling in 18 days of the sufficient water matched group in a left side is obviously increased, and the ibuprofen group obviously is suppressed, but gos up to some extent again in a week (28 days) after the drug withdrawal.Large, medium and small three dosage of WANGBI CHONGJI are suppressed than obvious swelling with the water matched group, too late ibuprofen group in 24 days, but do not see the phenomenon that swelling is gone up in 28 days, illustrate that WANGBI CHONGJI is more stable to allergy arthroncus curative effect.The Chinese medicine WANGBI CHONGJI has no side effect, but the long period medication, thus more demonstrate the advantage of long term effect.
The trend of right side foot is consistent with left side foot, but rising significantly appears in (the being drug withdrawal 3 days) swelling in 24 days of Western medicine ibuprofen group, and the large, medium and small dosage group of Chinese medicine WANGBI CHONGJI is more stable.(seeing shown in the chart)
2, the inhibitory action of PARA FORMALDEHYDE PRILLS(91,95) arthritis swelling:
50 of rats are divided into 5 groups at random: 1. matched group 2. the ibuprofen group 3. the WANGBI CHONGJI heavy dose organize 4. in the WANGBI CHONGJI 5. WANGBI CHONGJI small dose group of dosage group.Injected 0.1 milliliter in 2.5% formaldehyde down respectively at rat foot aponeurosis (aponeuroses) in 40 minutes behind the medicine.Cause scorching back and measured the foot swelling degree in 2,4,6,24,48,72,96 hours respectively.(the results are shown in Table)
2, hemolysin is measured:
Mouse peritoneal injects that 0.2 milliliter of 20% sheep hemocyte/only, the immunity back was gone eyeball to get blood on the 4th day and got serum, carried out hemolysin mensuration by the method in new drug (Western medicine) the immunoregulation medicament pharmacology test guide, the results are shown in Table.
The influence that WANGBI CHONGJI produces the mice hemolysin
(4) analgesic test:
1. analgesic experiment:
1. hot plate method: irritate stomach WANGBI CHONGJI extractum before the test, by 23.14 gram/kilograms, 11.57 gram/kilograms, 5.78 gram/kilograms, bucinnazine 0.06 gram/kilogram, matched group is irritated the water with volume, measures after the administration 0,20,40 with hot plate method respectively, the analgesic effect of 60,80,100 and 120 minutes different times.
(2) effect of promoting blood circulation to remove obstruction in the collateral
1, to the influence of capillary permeability
Experimentize by the Whittle method, mice prevents to large, medium and small three the dosage groups of Chinese medicine WANGBI CHONGJI and Western medicine prednisone group 5 days, after the administration in the 6th day 30 minutes, tail vein injection Yi Wensilan, the abdominal cavity injects 0.2 milliliter of 0.7% glacial acetic acid saline/only, pneumoretroperitoneum liquid was measured optical density value in 15 minutes, the results are shown in Table.
WANGBI CHONGJI is to the influence of vascular permeability
(3) to Immune Effects
1, to 2, the influence of 4-dinitrochlorobenzene (DNCB) induced mice skin of pinna delayed hypersensitivity.
Get 50 of mices, be divided into Western medicine prednisone group at random, water matched group, large, medium and small three the dosage groups of Chinese medicine WANGBI CHONGJI.Mouse part skin sensitization is coated with 5%DNCB ethanol liquid in the grouping back.Next day, 1%DNCB adds and is coated with sensitization and begins administration the previous day, and once a day, sensitization was coated with auris dextra with 1%DNCB (being dissolved in the olive oil) after 7 days in continuous 9 days, added once in 24 hours, and the both sides ear is weighed after 48 hours, asks two ear weight differences.The results are shown in Table
The anti-delayed allergy effect of WANGBI CHONGJI
| Group | The example number | Dosage | Two ear weight difference mg | Suppression ratio % | The P value | |
| The water matched group | 12 | Consubstantiality hydrops | 3.08±1.32 | |||
| Prednisone | 12 | 0.025g/KG | 1.16±0.8 | 62.3 | ＜0.01 | |
| WANGBI CHONGJI | Heavy dose of | 12 | 23.14g/KG | 1.076±0.95 | 65.0 | ＜0.01 |
| Middle dosage | 12 | 11.57g/KG | 1.66±1.88 | 46.0 | ＜0.05 | |
| Low dose of | 12 | 5.78g/KG | 2.8±2.7 | 9.0 | ＞0.05 | |
Description of drawings:
Fig. 1 brings out arthritic arthroncus size and the figure of time for the right foot of rat to cattle II Collagen Type VI
Fig. 2 brings out arthritic arthroncus size and the figure of time for rat left side foot to cattle II Collagen Type VI
Costumes bi Zheng medicine adds the inhibitory action that adjuvant brings out rat arthritis swelling to ox II Collagen Type VI
| Group | Number of animals | Dosage | Different time arthroncus size variation (MM3) | ||||||||||
| 0 | 5 | 10 | 15 | 18 | 21 | 24 | 28 | 34 (my god) | |||||
| Costumes numbness electuary | Greatly | 13 | Left | 1.028±0.046 | 1.064±0.049 | 2.000±0.151 | 1.678±0.192 | 1.742±0.139 | 1.721±0.215 | 1.621±0.176 | 1.521±0.083 | 1.435±0.223 | |
| Right | 1.028±0.046 | 1.071±0.046 | 1.057±0.051 | 1.035±0.063 | 1.15±0.145 | 1.092±0.073 | 1.078±0.057 | 1.007±0.026 | 1.014±0.036 | ||||
| In | 13 | Left | 1.014±0.037 | 1.028±0.046 | 1.985±0.174 | 1.892±0.289 | 1.850±0.140 | 1.871±0.278 | 1.707±0.223 | 1.542±0.150 | 1.458±0.115 | ||
| Right | 1.028±0.046 | 1.05±0.051 | 1.057±0.051 | 1.164±0.127 | 1.180±0.123 | 1.128±0.091 | 1.085±0.066 | 1.021±0.042 | 1.028±0.082 | ||||
| Little | 13 | Left | 1.038±0.065 | 1.038±0.065 | 2.107±0.221 | 1.691±0.232 | 1.866±0.238 | 1.691±0.344 | 1.650±0.116 | 1.541±0.156 | 1.491±0.192 | ||
| Right | 1.038±0.065 | 1.053±0.066 | 1.107±0.049 | 1.091±0.028 | 1.266±0.155 | 1.100±0.060 | 1.100±0.042 | 1.008±0.028 | 1.033±0.049 | ||||
| Fenbid | 12 | Left | 1.075±0.045 | 1.083±0.057 | 1.916±0.199 | 1.59±0.157 | 1.727±0.20 | 1.6±0.155 | 1.608±0.167 | 1.716±0.169 | 1.666±0.123 | ||
| Right | 1.11±0.093 | 1.091±0.028 | 1.05±0.052 | 1.036±0.050 | 1.245±0.112 | 11±0.063 | 1.075±0.062 | 1.633±0.246 | 1.516±0.038 | ||||
| The water contrast | 12 | Left | 1.076±0.073 | 1.076±0.073 | 2.184±0.331 | 1.915±0.353 | 2.35±0.294 | 1.876±0.276 | 1.707±0.284 | 1.661±0.256 | 1.661±0.232 | ||
| Right | 1.084±0.068 | 1.084±0.068 | 1.076±0.109 | 1.130±0.094 | 1.407±0.144 | 1.476±0.196 | 1.407±0.147 | 1.423±0.156 | 1.407±0.128 | ||||
Compare * P＜0.05 * * P＜0.01 with water control group left and right sides toes swelling size
Costumes bi Zheng medicine is to the inhibitory action of rat formaldehyde arthritis swelling
| Group | Number of animals | Dosage | Different time arthroncus size variation (hour) (MM3) | |||||||||
| 0 | 2 | 4 | 6 | 24 | 48 | 72 | 96 | |||||
| Costumes numbness electuary | Greatly | 10 | 23.4 g/kg | Left | 1.01±0.03 | 1.48±0.116 | 1.78±0.100 | 1.78±0.24 | 1.78±0.24 | 1.87±0.15 | 1.67±0.18 | 1.57±0.13 |
| Right | 1.0±0.0 | 1.06±0.09 | 1.15±0.09 | 1.17±0.15 | 1.17±0.11 | 1.47±0.13 | 1.12±0.09 | 1.16±0.08 | ||||
| In | 10 | 11.57 g/kg | Left | 1.0±0.0 | 1.6±0.16 | 1.87±0.14 | 2.0±0.25 | 1.93±0.29 | 2.05±0.17 | 1.68±0.16 | 1.60±0.25 | |
| Right | 1.0±0.0 | 1.07±0.09 | 1.32±0.12 | 1.19±0.16 | 1.28±0.16 | 1.55±0.11 | 1.18±0.06 | 1.15±0.09 | ||||
| Little | 10 | 5.78 g/kg | Left | 1.0±0.0 | 1.56±0.16 | 1.77±0.22 | 1.82±0.15 | 2.0±0.19 | 1.99±0.19 | 1.65±0.15 | 1.61±0.152 | |
| Right | 1.0±0.0 | 1.06±0.08 | 1.21±0.12 | 1.25±0.21 | 1.29±0.15 | 1.46±0.18 | 1.72±0.07 | 1.01±0.08 | ||||
| Fenbid | 10 | Left | 0.98±0.04 | 1.41±0.13 | 1.75±0.22 | 1.77±0.23 | 1.81±0.23 | 1.72±0.25 | 1.66±0.31 | 1.626±0.15 | ||
| Right | 0.99±0.03 | 1.00±0.13 | 1.11±0.08 | 1.17±0.09 | 1.15±0.09 | 1.23±0.19 | 1.14±0.08 | 1.15±0.14 | ||||
| The water contrast | 10 | Consubstantiality ponding | Left | 1.00±0.0 | 1.74±0.18 | 1.86±0.10 | 2.05±0.18 | 1.92±0.10 | 2.13±0.29 | 1.77±0.21 | 1.78±0.108 | |
| Right | 1.00±0.0 | 1.27±0.17 | 1.24±0.12 | 1.39±0.10 | 1.32±0.17 | 1.52±0.12 | 1.10±0.07 | 1.16±0.08 | ||||
Costumes numbness electuary is to the analgesic activity (hot plate method) of mouse
| Marshalling | Number of animals | Dosage g/kg | Lick X ± SD of sufficient time (second) | |||||||
| 0 | 20 | 40 | 60 | 80 | 100 | 120 | ||||
| Costumes numbness electuary | Heavy dose of | 10 | 23.4 | 24.3±4.47 | 28.2±9.66 | 31.4±12.18 | 40.3±18.18 | 41.04±19.23 | 56.3±28.96 | 46.9±23.4 |
| Middle dosage | 10 | 11.57 | 31.0±9.83 | 21.0±5.10 | 20.8±9.43 | 31.5±11.30 | 30.80±28.58 | 47.1±28.60 | 56.0±25.23 | |
| Low dose of | 10 | 5.78 | 25.9±10.82 | 20.9±7.34 | 23.8±9.22 | 36.7±21.17 | 41.20±27.37 | 50.43±34.20 | 52.4±21.9 | |
| AP-237 | 10 | 0.06 | 21.7±6.13 | 54.1±25.72 | 24.2±15.24 | 33.8±22.93 | 52.40±22.59 | 53.5±31.61 | 50.8±19.64 | |
| The water contrast | 10 | Consubstantiality ponding | 1.68±5.88 | 19.3±6.37 | 25.6±10.85 | 34.1±12.76 | 25.10±8.37 | 34.4±14.92 | 34.13±11.95 | |
Compare * P＜0.05 * * P＜0.01 with the water control group
2. writhing method: each group press respectively the hot plate method administration, and administration is after 40 minutes, and 0.2 milliliter in the glacial acetic acid of every animal lumbar injection 0.6 % is at once observed and begun writhing time and writhing number of times in 15 minutes.
Costumes numbness electuary is to the analgesic activity (writhing method) of mouse
| Marshalling | Number of animals | Dosage (g/kg) | The beginning writhing time | The writhing number of times |
| The low dose of AP-237 water contrast of dosage in the Costumes numbness heavy dose | 10 10 10 10 10 | 23.4 11.57 5.78 11.25 consubstantiality ponding | 473.3±236.74 499.2±193.31 * 320.5±179.52 649.91±217.88 ** 312.6±101.13 | 11.7±9.0 9.2±6.95 * 12.0±9.32 4.82±5.37 ** 22.2±9.48 |
Compare with the water control group*P＜0.05
**P＜0.01
The capillary permeability result of the test shows that the heavy dose of inhibiting rate of Costumes numbness is 38% (the dyestuff optical density is 0.2 17 ± 0.099), the dosage inhibiting rate is 49.1% (the dyestuff optical density is 0.178 ± 0.065) in the Costumes numbness, and the inhibiting rate of prednisone group is that 36.8% (the dyestuff optical density is 0.221 ± 0.092) compared P＜0.01 with water control group (the dyestuff optical density is 0.350 ± 0.082).
2,4-dinitrofluorobenzene (DNCB) brings out Result of the delayed-type hypersensitivity and shows the prednisone group, and the heavy dose of and middle dosage group of Costumes numbness and water control group be P＜0.01 relatively respectively, P＜0.01, and there is the effect of inhibition delayed allergy P＜0.0 5.
Hemolysin test is the result show, the heavy dose of group of Costumes numbness and hydrocortisone and water control group be P＜0.01 relatively respectively, and the effect that hemolysin produces that suppresses is arranged.
The analgesic test shows, hot plate method, and AP-237 onset in 20 minutes, and the ability onset in 100 to 120 minutes of the big or middle dosage of Costumes numbness electuary infer that Costumes numbness electuary may be by regulating body analgesia factors contribute. Writhing method is the result show, dosage has the chemical induced pain effect of inhibition in the Costumes numbness electuary, but effect is not as AP-237. With the water control group than P＜0.01.
Conclusion:
Costumes numbness electuary result of the test shows: this medicine has inhibition ox II Collagen Type VI and formaldehyde to bring out the effect of rat toes swelling, and effect is partially slow but curative effect is stable, and dosage in the change only of tentative mouse capillary permeability is had effect; Drug-induced skin Delayed onset abnormalism is reacted three dosage obvious inhibitory action is all arranged; To mouse produce antibody only heavy dose effect is arranged; Hot plate method and writhing method analgesic test show that Costumes numbness electuary has analgesic activity but the time is partially late.
Costumes numbness sheet Pharmacodynamic test of active extract
Summary Costumes numbness sheet has obvious inhibitory action to rat assist agent arthritis; Paraxylene causes mice ear obvious inhibitory action; On Carrageenan causes rat paw edema significant antagonism; Hot plate method and writhing method evidence Costumes numbness sheet have certain analgesic activity. The above results prompting, Costumes numbness sheet has stronger inhibitory action to various types of inflammation and pain reaction.
Test objective is verified the anti-inflammatory and antalgic activity of Costumes numbness sheet by multiple anti-inflammatory, analgesic test.
Test material
1, medicine Costumes numbness sheet, the heavy 0.5g of every plain sheet is equivalent to the 1.82g crude drug, and the 3rd pharmaceutical factory provides by Benxi, lot number: 990503. Getting plain sheet adds in right amount water and is made into desired concn. Wind-expelling pain-stopping capsule, every heavy 0.3g, Xianyang Buchang Pharmaceutical Co., Ltd produces, lot number: 991212.
2, reagent
BCG vaccine provides (for freeze drying powder injection), lot number: 991207 by Changchun Biological Products Institute.
The preparation of adjuvant: got atoleine and lanolin by 2: 1, heating mixes, stirs, and autoclaving 20 minutes, after the cooling, every 1ml adds BCG vaccine 6mg and makes. Histamine, Chinese Academy of Sciences Shanghai is biochemical to produce, and is made into 0.1% solution with physiological saline before the test.
Evans blue, FluKa import packing is made into 2% normal saline solution.
Carrageenan, Liaoning are given birth to medical industry research institute and are provided, and are made into 1% solution with physiological saline in 1 day before use.
3, animal Wistar rat is male, body weight 130-160g. Kunming mouse, male and female dual-purpose, body weight 20 ± 2g. Provide by animal housing of Shenyang Pharmaceutical University. The quality certification number: the real moving word 033 of the Liao Dynasty.
Test method and result
One, to the inhibitory action of rat assist agent arthritis
Get 50 of above-mentioned male rats, be divided at random 5 groups by body weight, 10 every group. Be large, medium and small three the dosage groups of blank group (waiting capacity physiological saline), wind-expelling pain-stopping capsule group (0.64g/kg) and Costumes numbness sheet (1.08g/kg, 0.54g/kg and 0.27g/kg). Before medicine, at every the left back ankle of rat joint intracutaneous injection adjuvant 0.1ml, then begin administration, every day 1 time, continuous 21 days. Behind medicine, surveyed left back ankle joint girth 1 time in 1,3,7,11,13 and 19 day, behind medicine, surveyed right back ankle joint girth 1 time in 9,11,13,15,17,19 and 21 days, with the difference of normal foot ankle-joint girth before the administration as swelling, carry out the t check between each group, the results are shown in Table 1-1 and table 1-2.
Table 1-1 is on impact (left side) n=10 of adjuvant arthritis ankle swelling in rat degree, x ± SD
| Group | Dosage (g/kg) | Different time (my god) left side ankle swelling degree (mm) | |||||
| 1 | 3 | 7 | 11 | 13 | 19 | ||
| Blank wind-expelling pain-stopping Costumes numbness sheet | - 0.64 1.08 0.54 0.27 | 1.80±1.03 1.50±0.78- 1.40±0.84 1.60±0.77 1.70±0.63 | 3.50±1.25 2.25±1.01 * 2.40±0.74 2.60±0.84 3.05±0.79 | 3.70±1.55 2.70±0.95 * 2.80±1.18 * 2.95±0.68 3.40±0.61 | 5.05±1.48 3.05±1.42 * 3.25±1.21 * 3.55±0.75 * 3.70±0.88 | 5.25±1.36 3.65±1.47 * 3.80±1.18 * 3.30±0.79 * 4.30±0.75 | 3.50±1.18 2.50±1.13 2.65±1.35 3.25±0.68 3.05±0.83 |
Compare * P＜0.05 with control group, compare P＞0.05 between other groups
Table 1-2 is on impact (right side) n=10 of adjuvant arthritis ankle swelling in rat degree, x ± SD
| Group | Dosage (g/kg) | Different time (my god) right side ankle swelling degree (mm) | ||||||
| 9 | 11 | 13 | 15 | 17 | 19 | 21 | ||
| Blank wind-expelling pain-stopping Costumes numbness sheet | - 0.64 1.08 0.54 0.27 | 0.50±033 0.45±0.37 0.35±0.34 0.40±0.32 0.50±0.41 | 1.10±0.70 0.85±0.41 0.70±0.26 0.65±0.24 0.70±0.42 | 1.70±0.89 1.20±0.63 1.05±0.44 0.95±0.37 1.1±0.46 | 2.05±0.83 1.50±0.71 1.25±0.63 1.45±050 1.50±0.62 | 1.75±0.79 1.40±039 1.20±0.59 1.25±0.63 1.80±0.71 | 1.60±0.57 130±0.48 1.10±0.46 0.95±0.44 1.30±0.67 | 1.50±0.33 1.00±0.53 0.90±0.39 0.85±0.34 0.95±0.49 |
N=10, x ± SD compares P＞0.05 with control group, compares P＞0.05 between other groups.
The result shows, the left back ankle of control rats joint namely began swelling the same day behind injection adjuvant, the 3rd day obvious tumefaction, continued for 1 week after further swelling, and also mild swelling of offside (right side) ankle-joint. Costumes numbness sheet continuous use 21 days, heavy dose of group and middle dosage group are comparatively obvious to the rat effect, and left back ankle swollen joint expansibility is significantly less than control group (P＜0.05). Its effect is suitable with wind-expelling pain-stopping capsule. To the Secondary cases swelling in right back ankle joint, each administration group though certain inhibitory action is arranged, because the control group swelling is not obvious, does not show obvious significant difference.
Two, paraxylene causes the inhibitory action of mice ear
Get 50 of male mices, be divided at random 5 groups by body weight, 10 every group. Be blank group (waiting capacity water), large, medium and small three the dosage groups of wind-expelling pain-stopping capsule group (0.92g/kg) and Costumes numbness sheet (1.54g/kg, 0.77g/kg and 0.39g/kg). Administration every day 1 time, successive administration 7 days, after the last administration 1 hour, auris dextra is coated with the caused by dimethylbenzene xylene inflammation, causes scorching rear 20 minutes, and animal is put to death in dislocation, downcut auricle in left and right sides ear same area with diameter 7mm card punch, weigh with weighing scale to test twisting force, as swelling, organize a t check with left and right sides ear weight difference. The results are shown in Table 2.
Table 2 paraxylene causes the impact (x ± SD) of mice ear
| Group | Dosage (g/kg) | Number of animals (n) | Ear swelling degree (mg) | Inhibiting rate (%) |
| Control group wind-expelling pain-stopping Costumes numbness sheet | - 0.92 1.54 0.77 0.39 | 10 10 10 10 10 | 5.41±1.48 3.81±1.18 * 3.78±1.01 ** 3.80±1.24 * 4.43±1.46 | - 29.6 29.8 27.0 18.1 |
Compare * P＜0.05 * * P＞0.01 with control group.
The result shows that the big or middle dosage group of Costumes numbness sheet obviously suppresses the mice ear (P＜0.05, P＜0.01) that dimethylbenzene brings out, and illustrates that the acute inflammation that this product paraxylene causes is formed with certain inhibitory action, and is better than wind-expelling pain-stopping capsule.
Three, on Carrageenan causes the inhibitory action of rat paw edema
Get 40 rats, be divided at random 5 groups, 8 every group, grouping and dosage together test one. Administration every day 1 time, successive administration 3 days. Before the last medicine, survey every Rat Right metapedes ankle-joint position girth with tape. After the last administration 1 hour, at Rat Right metapedes ankle-joint hypodermic injection carrageenan 0.1ml, afterwards, measure respectively 1,2,3,4,5 hour right back ankle joint girth, with the difference of girth before the administration as swelling, carry out the t check. The results are shown in Table 3.
Table 3 on Carrageenan causes the n=8 that affects of rat paw edema
| Group | Dosage (g/kg) | Different time (hour) right ankle swelling degree (X ± SD.mm) | ||||
| 1 | 2 | 3 | 4 | 5 | ||
| Control group wind-expelling pain-stopping Costumes numbness sheet | - 0.92 1.08 0.54 0.27 | 3.06±1.05 2.69±0.84 2.50±0.53 2.62±0.83 3.25±1.10 | 5.44±1.18 3.75±0.95 * 3.56±0.56 ** 3.81±0.92 * 4.50±1.22 | 5.94±0.86 3.94±0.86 ** 4.19±0.59 ** 4.31±0.53 ** 5.13±1.13 | 5.00±0.53 3.50±0.65 ** 3.69±0.59 ** 4.25±0.80 ** 4.44±1.02 | 3.81±0.65 2.81±0.59 ** 3.50±0.38 3.25±0.65 3.38±0.87 |
Compare * P＜0.05 * * P＜0.01 with control group.
The result shows, its ankle-joint obvious tumefaction behind the rat ankle and foot hypodermic injection carrageenan, the modeling success is described, the big or middle dosage group of Costumes numbness sheet and control group were 2,3,4 hours remarkable (P＜0.05 of comparing difference, P＜0.01), illustrates that this product has the effect that stronger inhibition carrageenan causes rat paw edema.
Four, mouse hot plate Pain test
Get female mice, body weight 20 ± 2g is put in respectively on the metallic plate (it is on 55 ± 0.5 ℃ the water surface of water bath with thermostatic control that metallic plate places temperature). Put into hot plate to the pain thresholding of the time of licking metapedes (second) as mouse with stopwatch record mouse. Select the pain thresholding and use mouse in the conduct test of 5-30 second. Get 50 of above-mentioned qualified mouse next day, by its pain thresholding size, be divided at random 5 groups, group and dosage are with test two. Administration every day 1 time, successive administration 7 days behind the last medicine 1 hour, places mouse on the hot plate record pain thresholding (second). Generally be limited with 60 seconds, surpass 60 seconds in 60 seconds, calculate the pain territory and improve percentage. The results are shown in Table 4.
The test of table 4 numbness sheet hot plate method in mice (X ± SD)
| Group | Dosage (g/kg) | Number of animals (n) | Pain thresholding (second) | Rate elongation (%) |
| The control group pain relieving numbness sheet that dispels the wind | - 0.92 1.54 0.77 0.39 | 10 10 10 10 10 | 17.94±4.20 22.13±5.83 24.04±7.43 * 23.94±5.95 20.94±534 | - 23.36 34.00 23.44 16.72 |
Compare * P＜0.05 with control group
The result shows that the heavy dose of mouse hot plate pain thresholding that obviously prolongs of Costumes numbness sheet has certain analgesic activity, and the effect of the pain relieving capsule that dispels the wind is not obvious.
Five, mouse writhing method pain test
Get 50 mouse, male and female half and half are divided into 5 groups at random by body weight and sex, 10 every group. Group and dosage are with test two. After the administration 0.5 hour, 0.2 milliliter in every animal lumbar injection 0.6% glacial acetic acid is observed writhing number of times in 20 minutes at once. The results are shown in Table 5.
The test of table 5 Costumes numbness sheet mouse writhing method
| Group | Dosage (g/kg) | Number of animals (n) | The writhing number of times |
| The control group pain relieving Costumes numbness sheet that dispels the wind | - 0.92 1.54 0.77 0.39 | 10 10 10 10 10 | 31.6±3.47 10.5±4.26 ** 14.5±3.34 ** 22.1±3.78 * 27.5±5.10 |
Compare * P＜0.05 * * P＜0.01 with control group
Results suggest, Costumes numbness sheet obviously reduce writhing number of times in the mouse 20 minutes, have certain analgesic activity, and it acts on a little less than the pain relieving capsule that dispels the wind.
Conclusion (of pressure testing)
Foot swelling has obvious inhibitory action to Costumes numbness sheet to adjuvant arthritis rats; Paraxylene causes the mouse ear swelling obvious inhibitory action; On Carrageenan causes rat paw edema also obvious inhibitory action; Has certain analgesic activity by hot plate method and writhing method evidence Costumes numbness sheet.
List of references
1, bureau of drug administration of Ministry of Health of the People's Republic of China: study of tcm new drug guide, 1994; 181
2, Qi Chen chief editor: the herbal pharmacology research science of law, People's Health Publisher, version in 1996; 364-377
Wangbi granules III phase clinical experiment final report
Wangbi granules is one of sick serial medicine of national three kind new medicine numbness, and for Chinese Chinese medicine and pharmacy is understood rheumatism association cipher prescription, Liver and kidney two deficiency syndrome in the treatment traditional Chinese medical science rheumatism are waited.This medicine is chosen as national essential drugs, and Chinese medicine protection kind and " medical insurance " medication by national requirements, need that this medicine is carried out clinical efficacy and revalue, and carry out safety and investigate, and the spy carries out III phase clinical experiment.We are from April in August, 2000 to calendar year 2001, can the tissue whole nation 12 tame hospitals of rheumatism association carry out open clinical observation by Chinese Chinese medicine and pharmacy, observe patient's 432 examples altogether, test group 326 examples wherein, and matched group 106 examples now are reported as follows the result.
General material
One, case source: this group is totally 432 examples, inpatient's 112 examples wherein, outpatient's 320 examples.
Two, sex: two groups of patient's sex ratios see Table 1
Table 1 liang group patient sex ratio
| Group | The example number | Male N (%) | Women N (%) |
| The test group matched group | 326 106 | 187(57.36) 57(53.77) | 139(42.64) 49(46.23) |
Test group and matched group compare: X
2=0.28577 P＞0.05
Two groups of patients there was no significant difference on sex distributes is described, has comparability.
Three, two groups of patient ages distribute relatively, see Table 2
Table 2 liang group patient age distribution comparison (year)
| Group | The example number | ≤30 N(％) | 31～40 N(％) | 41～50 N(％) | 51～65 N(％) | Mean age X ± S |
| The test group matched group | 326 106 | 56(17.18) 21(19.81) | 70(20.47) 21(19.81) | 110(33.74) 35(33.02) | 90(27.61) 29(27.36) | 45.88±9.76 46.90±12.17 |
Test group and matched group compare: X
2=0.38467 P＞0.05
Two groups of patients there was no significant difference in age distribution is described, has comparability.
Four, two groups of patient's courses of disease relatively see Table 3
The table 3 liang group patient course of disease relatively
| Group | The example number | ≤ 6 months N (%) | Half a year～N (%) | 2 years～N (%) | 5 years～N (%) | 10 years～N (%) | Average course of disease X ± S |
| The experimental group matched group | 326 106 | 26(7.98) 6(5.66) | 53(16.26) 24(22.64) | 157(48.16) 44(32.06) | 69(21.17) 24(22.64) | 21(6.44) 7(6.60) | 4.57±2.09 9.30±2.71 |
Test group and matched group compare: X
2=3.13117 P＞0.05
Illustrate that two groups of patients relatively go up there was no significant difference in the course of disease, have comparability.
Five, the sick kind distributes relatively, sees Table 4
The sick kind of table 4 distributes relatively
| Group | The example number | RA N(％) | AS N(％) | OA N(％) |
| The test group matched group | 326 106 | 148(45.4) 39(36.79) | 48(14.72) 22(20.76) | 130(39.88) 45(42.45) |
Test group and matched group compare: X
2=3.29516 P＞0.05
Two groups of patients there was no significant difference on the disease kind distributes is described, has comparability.
Six, syndrome degree: two groups of patient's syndrome degree relatively see Table 5
Table 5 liang group patient syndrome degree relatively
| Group | The example number | Slight N (%) | Moderate N (%) | Severe N (%) |
| The test group matched group | 326 106 | 34(10.43) 16(15.10) | 216(66.26) 65(61.32) | 76(23.31) 25(23.59) |
Test group and matched group compare: X
2=1.80622 P＞0.05
Two groups of patients there was no significant difference on the syndrome degree is described, has comparability.
Test method
One. diagnostic criteria
(1) Liver and kidney two deficiency syndrome
Arthralgia, local enlargement, stiff deformity, wasting and atrophy of muscle, joint stuffiness, aversion to cold and preference for warmth, hands and feet being not warm, soreness of the waist and knees, tongue warp or light.White and thin fur.Deep-thready pulse.
(2) Western medicine diagnose standard
According to the therapeutic efficiency of rheumatoid arthritis (granule, tablet), select sick kind of following doctor trained in Western medicine to carry out clinical observation.
1. rheumatoid arthritis (RA) diagnostic criteria (Americanism damp disease association revision diagnostic criteria in 1987)
(1) morning deadlock at least 1 hour, continued at least 6 weeks.
(2) 3 or the arthroncus more than 3 continued at least 6 weeks.
(3) carpal joint, metacarpophalangeal joints or 6 weeks of nearly articulations digitorum manus swelling or more than.
(4) symmetry arthroncus.
(5) the X line of hands changes.
(6) rheumatoid nodules.
(7) the rheumatoid factor positive.
In above-mentioned 7, have 4 or above person and can be diagnosed as RA.
2. ankylosing spondylitis diagnostic criteria (the New York standard of revision in 1984)
(1) clinical criteria
1. low back pain continues at least 3 months, can alleviate after the activity, has a rest not have and improves
2. lumbar vertebra is at the limitation of activity of vertical and horizontal plane
3. the thorax mobility be lower than corresponding age, property others
(2) radiology standard
3～4 grades of bilateral sacroiliitis 〉=2 grade or one-sided sacroiliitises
Make a definite diagnosis: meet radiology standard and 1 above clinical criteria.
3. knee osteoarthritis diagnostic criteria (adopting Americanism damp disease association standard)
Most of date gonalgias since (1) one month;
(2) the X line shows edge, joint hyperosteogeny;
(3) (transparent, viscosity reduces OA synovial membrane liquid more, WBC＞2100/ml);
(4) person that can not look into the synovial fluid, the age must 〉=40 years old;
(5) morning deadlock≤30min;
(6) snap sound is arranged during joint motion.
It is all diagnosable to satisfy (1) (2) or (1) (3) (5) (6) or (1) (4) (5) (6) person
Two. test case standard
(1) case is included standard in
1. meet above-mentioned tcm syndrome standard and certain Western medicine diagnose person, all can include the object of observation in.
2. the age is between 18～65 years old.
(2) case is got rid of and the rejecting standard
1. do not meet and include standard person in.
2. gestation or women breast-feeding their children, serious primary diseases such as allergic constitution or this medicine allergy sufferers merged is had the inclination, cerebrovascular, liver, kidney, hemopoietic system, psychotic.
3. not medication in accordance with regulations can't be judged the infull person of curative effect or data.
Three. observational technique
(1) medicine
1. test drug: wangbi granules, rheumatoid arthritis tablet, specification: granule is the 10g/ bag; Tablet is 0.25g, and being produced by Benxi, Liaoning Province the 3rd pharmaceutical factory provides.
2. contrast medicine: ZHENGQINGFENGTONGNING PIAN, specification are the 20mg/ sheet, produce (authentication code: ZZ-5365 defends in Hunan the accurate word 1992 of medicine No. 023069) by Zhengqing Pharmaceutical Group Corp., Ltd., Hunan Prov., and Benxi the 3rd pharmaceutical factory provides.
(2) test method
1. the object of observation is for being in hospital and the out-patient.
2. grouping: adopt contrast method at random, case is pressed groups of grains: the tablet group: matched group distributes, and ratio is 3: 3: 1.
3. medication: groups of grains, each 1 bag, 3 times on the one; The tablet group, each 6,3 times on the one; Matched group, 2 of first clothes, 3 times on the one, having no adverse reaction after the week adds to each 3, three times on the one.
4. course of treatment: rheumatoid arthritis and ankylosing spondylitis, be 2 months the course of treatment; Knee osteoarthritis, be 1 month the course of treatment.
Four. observation index
(1) safety observation
1. general health check-up project
2. blood, urine, just routine examination
3. electrocardiogram, liver, kidney function test
(2) health giving quality observation
1. symptom grade scale:
1. arthralgia:
0 minute: do not have
1 minute: mild pain, can stand, do not influence sleep.
2 minutes: moderate pain, inertia be pain also.
3 minutes: pain was difficult to stand, and influences function.
2. arthroncus:
0 minute: do not have
1 minute: mild swelling, near bone mark was clear.
2 minutes: swelling was equal with near bone mark.
3 minutes: obviously swelling, bone mark was unclear.
3. articular pain:
0 minute: do not have.
1 minute: weight at the edge, joint or when touching ligament, patient claimed that pain is arranged.
2 minutes: weight patient claimed that pain is arranged, and frowns discomfort, and activity is slightly limited.
3 minutes: the severe tenderness, pressing slightly promptly has pain and shrinks back, and passive activity is seriously limited.
4. morning deadlock:
0 minute: do not have.
1 minute: morning stiff time＜30 minute.
2 minutes: morning stiff time 〉=30 minute,＜60 minutes.
3 minutes: morning stiff time 〉=60 minute.
5. function of joint:
0 minute: function was normal.
1 minute: slightly limited, can be engaged in normal activity.
2 minutes: obviously limited, life can be taken care of oneself, but can not be engaged in general activity.
3 minutes: the movable function forfeiture, can't take care of oneself.
6. soreness of the waist and knees:
0 minute: do not have
1 minute: have
7. joint deformity:
0 minute: do not have
1 minute: have
8. wasting and atrophy of muscle:
0 minute: do not have
1 minute: have
The mild symptoms major punishment is fixed:
Slightly: integration＜5 minute
Moderate: integration 6～10 minutes
Severe: integration＞10 minute
(2) both hands grip: all write down the numerical value (mmHg) that is reached before and after the treatment.
(3) picture of the tongue pulse condition observation.
(4) laboratory indexes observation: ESR, CRP, RF, blood uric acid.
(5) untoward reaction observation:, itemized record with the relevant untoward reaction of curative possibility.
The symptom efficacy determination:
Control: reduce to 0 fen person through the treatment symptom integral.
Produce effects: reduce by 2 fens persons through the treatment symptom integral.
Effectively: reduce by 1 fen person through the treatment symptom integral.
Five. traditional Chinese medical science disease curative effect determinate standard (according to new Chinese medicine clinical guidance principle standard)
Clinic control: treat the back symptom and disappear substantially, symptom was promptly divided 0～1 fen.
Produce effects: treat the back symptom and be clearly better, symptom is promptly divided decline 〉=2/3
Effectively: treat the back doing well,improving, symptom is promptly divided decline 〉=1/3.
Invalid: as not reach effective standard.
Six. the efficacy assessment standard of treatment rheumatism sexually transmitted disease (STD) in the curative effect of disease standard (with reference to new drug (Western medicine) clinical guidance principle).
Clinical remission: symptom, sign disappear, and the laboratory leading indicator is recovered or be approaching normal.
Produce effects: symptom, sign disappear substantially, and the laboratory leading indicator is obviously improved, decline degree 〉=50%.
Effectively: symptom, sign alleviate, and the laboratory leading indicator also has improvement.
Invalid: symptom, sign and laboratory leading indicator do not have improvement.
Annotate: laboratory indexes computational methods erythrocyte sedimentation rate, c reactive protein, numeral-normal value before the numeral-treatment back numeral/treatment before the treatment; 〉=two dilution factors of rheumatoid factor decline
Result of the test
One, total effects analysis: two groups of clinical total effectses of patient relatively see Table 6
Table 6 liang group patient clinical efficacy relatively
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | The above rate N of produce effects (%) | Total effective rate N (%) |
| The test group matched group | 326 106 | 38(11.66) 6(5.66) | 97(29.75) 32(30.19) | 157(48.16) 49(46.23) | 34(10.43) 19(17.93) | 135(41.41) 38(35.85) | 292(89.57) 87(82.08) |
Annotate:
*Total effective rate=clinic control rate+obvious effective rate+effective percentage
Test group and matched group compare: Ridit analyzes: u=1.736 P＞0.05
Illustrate: the clinical total effects of test group and matched group is there was no significant difference relatively.
Two, symptom curative effect
1, two groups of patient's arthralgia treatment front and back curative effects relatively see Table 7
Curative effect relatively before and after the table 7 liang group patient arthralgia treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 326 106 | 70(21.47) 16(15.09) | 85(26.07) 27(25.47) | 149(45.71) 49(46.23) | 22(6.75) 14(13.21) |
Test group and matched group compare: U=1.97 P＞0.05
Illustrate: test group and matched group compare there was no significant difference to the arthralgia curative effect.
2, two groups of patient's arthroncus treatment front and back curative effects relatively see Table 8
Curative effect relatively before and after the table 8 liang group patient arthroncus treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 298 90 | 74(24.83) 21(23.33) | 70(23.49) 17(18.89) | 106(35.57) 26(28.89) | 48(16.11) 26(28.89) |
Test group and matched group compare: U=1.574 P＞0.05
Illustrate that test group improves arthroncus curative effect and matched group zero difference.
3, two groups of patient's articular pain treatment front and back curative effects relatively see Table 9
Curative effect relatively before and after the table 9 liang group patient articular pain treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 324 102 | 56(17.28) 16(15.69) | 53(16.36) 22(21.57) | 170(52.47) 46(45.10) | 45(13.89) 18(17.65) |
Test group and matched group relatively Ridit are analyzed: U=8.31 P＞0.05
Illustrate that test group improves articular pain curative effect and matched group zero difference.
4, two groups of patient's joint function disturbance treatment front and back curative effects relatively see Table 10
Curative effect relatively before and after the table 10 liang group patient joint function disturbance treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 298 98 | 40(13.42) 19(19.39) | 37(12.41) 11(11.23) | 122(40.94) 33(33.67) | 99(33.22) 35(35.71) |
Test group and matched group relatively Ridit are analyzed: U=1.96 P＞0.05
Illustrate that test group improves joint function disturbance curative effect and matched group zero difference.
5, stiff treatment in morning front and back, two groups of patient joints curative effect relatively sees Table 11
Curative effect relatively before and after the table 11 liang stiff treatment in group patient joint morning
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 174 43 | 38(21.84) 8(18.61) | 47(27.01) 13(30.23) | 71(40.80) 15(34.88) | 18(10.34) 7(16.28) |
Test group and matched group compare: Ridit analyzes U=0.47 P＞0.05
Illustrate that test group improves stiff curative effect and matched group zero difference in joint morning.
Three, the curative effect of the two groups of different sick kind treatment of patient front and back relatively
1. curative effect relatively sees Table 12 before and after the two category rheumatic arthritis patient treatments
Curative effect relatively before and after the table 12 liang category rheumatic arthritis patient treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effective rate (%) |
| The test group matched group | 148 39 | 20(13.51) 2(5.13) | 50(33.78) 10(25.64) | 64(43.24) 18(46.15) | 14(9.46) 9(23.08) | 90.54 76.92 |
Test group and matched group compare: Ridit analyzes: u=2.297 P＜0.05
Illustrate: test group and treatment of control group rheumatoid arthritis curative effect relatively have significant difference.
2. two groups of patients with ankylosing spondylitis treatment front and back curative effects relatively see Table 13
Curative effect relatively before and after the table 13 liang group patients with ankylosing spondylitis treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effective rate (%) |
| The test group matched group | 48 22 | 4(8.33) 1(4.55) | 16(33.33) 4(18.18) | 23(47.92) 11(50.00) | 5(10.42) 6(27.27) | (89.58) (72.72) |
Test group and matched group compare: Ridit analyzes: u=1.80 P＞0.05
Illustrate: test group and treatment of control group ankylosing spondylitis curative effect be there was no significant difference relatively.
3. two groups of osteoarthritis patient treatment front and back curative effects relatively see Table 14
Curative effect relatively before and after the table 14 liang group osteoarthritis patient treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effective rate (%) |
| The test group matched group | 130 45 | 23(17.69) 6(12.5) | 22(16.92) 9(18.75) | 77(59.23) 26(54.17) | 8(6.15) 7(14.58) | 122(93.58) 41(85.42) |
Test group and matched group compare: Ridit analyzes: u=1.012 P＞0.05
Illustrate: test group and treatment of control group osteoarthritis curative effect be there was no significant difference relatively.
Four, the two groups of main laboratory indexes treatment of patient front and back curative effects relatively.
1. curative effect relatively sees Table 15 before and after the erythrocyte sedimentation rate treatment
Curative effect compares X ± S before and after the treatment of table 15 erythrocyte sedimentation rate
| Group | The example number | Before the treatment | After the treatment | P |
| The test group matched group | 187 60 | 67.33±14.96 35.98±7.10 | 20.76±9.51 18.82±6.71 | ＜0.05 ＜0.05 |
Illustrate before and after the test group self and relatively aspect the reduction erythrocyte sedimentation rate curative effect significant difference is being arranged; Significant difference is relatively arranged before and after the matched group self.
2.C curative effect relatively sees Table 16 before and after the reactive protein treatment.
Curative effect relatively before and after the treatment of table 16C reactive protein
| Group | The example number | Before the treatment | After the treatment | Negative conversion rate | P | ||
| Negative | Positive | Negative | Positive | ||||
| The test group matched group | 187 31 | 119 9 | 68 22 | 143 14 | 44 17 | 35.3 22.7 | ＜0.01 ＞0.05 |
Illustrate before and after the test group self significant differences is relatively arranged; Compare there was no significant difference before and after the matched group self.
3. curative effect relatively sees Table 17 before and after the treatment of rheumatoid arthritis patients rheumatoid factor
Curative effect relatively before and after the treatment of table 17 rheumatoid factor
| Group | The example number | Before the treatment | After the treatment | Negative conversion rate | P | ||
| Negative | Positive | Negative | Positive | ||||
| The test group matched group | 141 33 | 26 6 | 115 27 | 65 11 | 76 22 | 33.9 18.5 | ＞0.05 ＞0.05 |
Before and after being described, test group self compares there was no significant difference; Compare there was no significant difference before and after the matched group self.
Safety detects
In clinical trial, whole experimenters have been carried out the safety detection, the results are shown in Table 18.
Table 18 experimental group patient safety detects
| Project | The example number | Before the treatment | After the treatment | ||
| Normally | Unusually | Normally | Unusually | ||
| Routine blood test routine urinalysis stool routine examination GPT BUN Cr electrocardiogram | 326 326 326 326 326 326 257 | 322 317 318 317 318 318 257 | 4 9 8 1 0 0 4 | 325 324 322 318 318 318 257 | 1 2 4 0 0 0 4 |
Untoward reaction
Do not have
Discuss
Wangbi granules is made up of medicines such as giving birth to Radix Rehmanniae Preparata, Rhizoma Drynariae, Herba Epimedii, Radix Angelicae Pubescentis, Ramulus Cinnamomi, Flos Carthami, and full side has invigorating the liver and kidney, bone and muscle strengthening, wind-damp dispelling, the effect of the meridian dredging, the adaptation syndrome of this medicine is Liver and kidney two deficiency syndrome, cure mainly arthroncus, distortion, joint stuffiness, ankylosis, wasting and atrophy of muscle, row step difficulty, with soreness of the waist and knees, aversion to cold and preference for warmth, hands and feet being not warm, pale tongue with white fur or whiten, deep-thready pulse or fine and smooth.We in strict accordance with above-mentioned standard, have carried out the III clinical trial phase in clinical, the III clinical trial phase is the result show:
1, two groups of total effectses are compared: test group 326 examples, and above 135 examples of produce effects, obvious effective rate is 41.41%; Effective 157 examples, effective percentage are 48.16%; Total effective rate is 89.57%.Matched group 106 examples, above 135 examples of produce effects, obvious effective rate is 35.85%; Effective 49 routine effective percentage are 46.23%; Total effective rate is 82.08%.Two groups of medicine total effectses are compared, and its curative effect and matched group there was no significant difference are described according to tcm syndrome differentiation and treatment.
2, arthralgia, swelling, morning deadlock, handicapped improvement compared:
3, improvement is compared to lab index such as erythrocyte sedimentation rate, reactive protein, rheumatoid factor: its curative effect and matched group there was no significant difference.
4, compare treating each single sick rheumatoid arthritis, ankylosing spondylitis, osteoarthritis treatment result: treatment its curative effect of rheumatoid arthritis and matched group have significant difference; And treatment ankylosing spondylitis, its curative effect of osteoarthritis and matched group there was no significant difference.
Above result shows that wangbi granules has the effect of invigorating the liver and kidney, bone and muscle strengthening, removing obstruction in the collateral to relieve pain really.
Wangbi granules does not have obvious adverse reaction, and the heart, liver, kidney, hemogram etc. are all had no adverse effects, and in present oral dose, course of treatment scope, drug safety has no side effect, and is a kind of safe and effective medicine that rheumatism belongs to Liver and kidney two deficiency syndrome for the treatment of.
Test unit:
Guang-amen Hospital, China Traditional Chinese Medicine Instl
Shanghai brilliance hospital
Shanghai City institute of traditional Chinese medicine
Henan rheumatism hospital
Luoyang bonesetting hospital
The Beijing Jishuitan Hospital
Hospital Attached to Liaoning Inst. of Traditional Chinese Medicine
Gansu Provincial Hospital of Traditional Chinese Medicine
Tangshan City institute of traditional Chinese medicine
The Provincial Medicine Research Institute, Gansu
Benxi Hospital of Traditional Chinese Medicine
Rheumatoid arthritis sheet III phase clinical experiment final report
The rheumatoid arthritis sheet is one of sick serial medicine of national three kind new medicine numbness, and for Chinese Chinese medicine and pharmacy is understood rheumatism association cipher prescription, Liver and kidney two deficiency syndrome in the treatment traditional Chinese medical science rheumatism are waited.This medicine is chosen as national essential drugs, and Chinese medicine protection kind and " medical insurance " medication by national requirements, need that this medicine is carried out clinical efficacy and revalue, and carry out safety and investigate, and the spy carries out III phase clinical experiment.We are from April in August, 2000 to calendar year 2001, can the tissue whole nation 12 tame hospitals of rheumatism association carry out Ji by Chinese Chinese medicine and pharmacy and put the formula clinical observation, observe patient's 409 examples altogether, test group 303 examples wherein, and matched group 106 examples now are reported as follows the result.
General material
One, case source: this group is totally 303 examples, inpatient's 124 examples wherein, outpatient's 179 examples.
Two, sex: two groups of patient's sex ratios see Table 1
Table 1 liang group patient sex ratio
| Group | The example number | Male N (%) | Women N (%) |
| The test group matched group | 303 106 | 155(51.15) 57(53.77) | 148(48.84) 49(46.23) |
Test group and matched group compare: X
2=0.21566 P＞0.05
Two groups of patients there was no significant difference on sex distributes is described, has comparability.
Three, two groups of patient ages distribute relatively, see Table 2
Table 2 liang group patient age distribution comparison (year)
| Group | The example number | ≤30 N(％) | 31～40 N(％) | 41～50 N(％) | 51～65 N(％) | Mean age X ± S |
| The test group matched group | 303 106 | 60(19.80) 21(19.81) | 48(15.84) 21(19.81) | 89(29.37) 35(33.02) | 106(34.98) 29(27.36) | 49.21±11.61 46.90±12.17 |
Test group and matched group compare: X
2=2.46108 P＞0.05
Two groups of patients there was no significant difference in age distribution is described, has comparability.
Four, two groups of patient's courses of disease relatively see Table 3
The table 3 liang group patient course of disease relatively
| Group | The example number | ≤ 6 months N (%) | Half a year～N (%) | 2 years～N (%) | 5 years～N (%) | 10 years～N (%) | Average course of disease X ± S |
| The experimental group matched group | 303 106 | 33(10.89) 6(5.66) | 73(24.09) 24(22.64) | 126(41.58) 44(32.06) | 63(20.79) 24(22.64) | 8(2.64) 7(6.60) | 16.73±3.78 9.30±2.7 |
Test group and matched group compare: X
2=5.82708 P＞0.05
Illustrate that two groups of patients relatively go up there was no significant difference in the course of disease, have comparability.
Five, the sick kind distributes relatively, sees Table 4
The sick kind of table 4 distributes relatively
| Group | The example number | RA N(％) | AS N(％) | OA N(％) |
| The test group matched group | 303 106 | 119(39.27) 39(36.79) | 55(18.15) 22(20.76) | 129(42.57) 45(42.45) |
Test group and matched group compare: X
2=0.40805 P＞0.05
Two groups of patients there was no significant difference on the disease kind distributes is described, has comparability.
Six, syndrome degree: two groups of patient's syndrome degree relatively see Table 5
Table 5 liang group patient syndrome degree relatively
| Group | The example number | Slight N (%) | Moderate N (%) | Severe N (%) |
| The test group matched group | 303 106 | 36(11.88) 16(15.10) | 201(66.34) 65(61.32) | 66(21.78) 25(23.59) |
Test group and matched group compare: X
2=1.05617 P＞0.05
Two groups of patients there was no significant difference on the syndrome degree is described, has comparability.
Test method
One. diagnostic criteria
(1) Liver and kidney two deficiency syndrome
Arthralgia, local enlargement, stiff deformity, wasting and atrophy of muscle, joint stuffiness, aversion to cold and preference for warmth, hands and feet being not warm, soreness of the waist and knees, tongue warp or light.White and thin fur.Deep-thready pulse.
(2) Western medicine diagnose standard
According to the therapeutic efficiency of rheumatoid arthritis (granule, tablet), select sick kind of following doctor trained in Western medicine to carry out clinical observation.
1. rheumatoid arthritis (RA) diagnostic criteria (Americanism damp disease association revision diagnostic criteria in 1987)
(1) morning deadlock at least 1 hour, continued at least 6 weeks.
(2) 3 or the arthroncus more than 3 continued at least 6 weeks.
(3) carpal joint, metacarpophalangeal joints or 6 weeks of nearly articulations digitorum manus swelling or more than.
(4) symmetry arthroncus.
(5) the X line of hands changes.
(6) rheumatoid nodules.
(7) the rheumatoid factor positive.
In above-mentioned 7, have 4 or above person and can be diagnosed as RA.
2. ankylosing spondylitis diagnostic criteria (the New York standard of revision in 1984)
(1) clinical criteria
1. low back pain continues at least 3 months, can alleviate after the activity, has a rest not have and improves
2. lumbar vertebra is at the limitation of activity of vertical and horizontal plane
3. the thorax mobility be lower than corresponding age, property others
(2) radiology standard
3～4 grades of bilateral sacroiliitis 〉=2 grade or one-sided sacroiliitises
Make a definite diagnosis: meet radiology standard and 1 above clinical criteria.
3. knee osteoarthritis diagnostic criteria (adopting Americanism damp disease association standard)
Most of date gonalgias since (1) one month;
(2) the X line shows edge, joint hyperosteogeny;
(3) (transparent, viscosity reduces OA synovial membrane liquid more, WBC＞2100/ml);
(4) person that can not look into the synovial fluid, the age must 〉=40 years old;
(5) morning deadlock≤30min;
(6) snap sound is arranged during joint motion.
It is all diagnosable to satisfy (1) (2) or (1) (3) (5) (6) or (1) (4) (5) (6) person.
Two. test case standard
(1) case is included standard in
1. meet above-mentioned tcm syndrome standard and certain Western medicine diagnose person, all can include the object of observation in.
2. the age is between 18～65 years old.
(2) case is got rid of and the rejecting standard
1. do not meet and include standard person in.
2. gestation or women breast-feeding their children, serious primary diseases such as allergic constitution or this medicine allergy sufferers merged is had the inclination, cerebrovascular, liver, kidney, hemopoietic system, psychotic.
3. not medication in accordance with regulations can't be judged the infull person of curative effect or data.
Three. observational technique
(1) medicine
1. test drug: wangbi granules, rheumatoid arthritis tablet, specification: granule is the 10g/ bag; Tablet is 0.25g, and being produced by Benxi, Liaoning Province the 3rd pharmaceutical factory provides.
2. contrast medicine: ZHENGQINGFENGTONGNING PIAN, specification are the 20mg/ sheet, produce (authentication code: ZZ-5365 defends in Hunan the accurate word 1992 of medicine No. 023069) by Zhengqing Pharmaceutical Group Corp., Ltd., Hunan Prov., and Benxi the 3rd pharmaceutical factory provides.
(2) test method
1. the object of observation is for being in hospital and the out-patient.
2. grouping: adopt contrast method at random, case is pressed groups of grains: the tablet group: matched group distributes, and ratio is 3: 3: 1.
3. medication: groups of grains, each 1 bag, 3 times on the one; The tablet group, each 6,3 times on the one; Matched group, 2 of first clothes, 3 times on the one, having no adverse reaction after the week adds to each 3, three times on the one.
4. course of treatment: rheumatoid arthritis and ankylosing spondylitis, be 2 months the course of treatment; Knee osteoarthritis, be 1 month the course of treatment.
Four. observation index
(1) safety observation
1. general health check-up project
2. blood, urine, just routine examination
3. electrocardiogram, liver, kidney function test
(2) health giving quality observation
1. symptom grade scale:
1. arthralgia:
0 minute: do not have
1 minute: mild pain, can stand, do not influence sleep.
2 minutes: moderate pain, inertia be pain also.
3 minutes: pain was difficult to stand, and influences function.
2. arthroncus:
0 minute: do not have
1 minute: mild swelling, near bone mark was clear.
2 minutes: swelling was equal with near bone mark.
3 minutes: obviously swelling, bone mark was unclear.
3. articular pain:
0 minute: do not have.
1 minute: weight at the edge, joint or when touching ligament, patient claimed that pain is arranged.
2 minutes: weight patient claimed that pain is arranged, and frowns discomfort, and activity is slightly limited.
3 minutes: the severe tenderness, pressing slightly promptly has pain and shrinks back, and passive activity is seriously limited.
4. morning deadlock:
0 minute: do not have.
1 minute: morning stiff time＜30 minute.
2 minutes: morning stiff time 〉=30 minute,＜60 minutes.
3 minutes: morning stiff time 〉=60 minute.
5. function of joint:
0 minute: function was normal.
1 minute: slightly limited, can be engaged in normal activity.
2 minutes: obviously limited, life can be taken care of oneself, but can not be engaged in general activity.
3 minutes: the movable function forfeiture, can't take care of oneself.
6. soreness of the waist and knees:
0 minute: do not have
1 minute: have
7. joint deformity:
0 minute: do not have
1 minute: have
8. wasting and atrophy of muscle:
0 minute: do not have
1 minute: have
The mild symptoms major punishment is fixed:
Slightly: integration＜5 minute
Moderate: integration 6～10 minutes
Severe: integration＞10 minute
(2) both hands grip: all write down the numerical value (mmHg) that is reached before and after the treatment.
(3) picture of the tongue pulse condition observation.
(4) laboratory indexes observation: ESR, CRP, RF, blood uric acid.
(5) untoward reaction observation:, itemized record with the relevant untoward reaction of curative possibility.
The symptom efficacy determination:
Control: reduce to 0 fen person through the treatment symptom integral.
Produce effects: reduce by 2 fens persons through the treatment symptom integral.
Effectively: reduce by 1 fen person through the treatment symptom integral.
Five. traditional Chinese medical science disease curative effect determinate standard (according to new Chinese medicine clinical guidance principle standard)
Clinic control: treat the back symptom and disappear substantially, symptom was promptly divided 0～1 fen.
Produce effects: treat the back symptom and be clearly better, symptom is promptly divided decline 〉=2/3
Effectively: treat the back doing well,improving, symptom is promptly divided decline 〉=1/3.
Invalid: as not reach effective standard.
Six. the efficacy assessment standard of treatment rheumatism sexually transmitted disease (STD) in the curative effect of disease standard (with reference to new drug (Western medicine) clinical guidance principle).
Clinical remission: symptom, sign disappear, and the laboratory leading indicator is recovered or be approaching normal.
Produce effects: symptom, sign disappear substantially, and the laboratory leading indicator is obviously improved, decline degree 〉=50%.
Effectively: symptom, sign alleviate, and the laboratory leading indicator also has improvement.
Invalid: symptom, sign and laboratory leading indicator do not have improvement.
Annotate: laboratory indexes computational methods erythrocyte sedimentation rate, c reactive protein, numeral-normal value before the numeral-treatment back numeral/treatment before the treatment; 〉=two dilution factors of rheumatoid factor decline
Result of the test
One, total effects analysis: two groups of clinical total effectses of patient relatively see Table 6
Table 6 liang group patient clinical efficacy relatively
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | The above rate N of produce effects (%) | Total effective rate N (%) |
| The test group matched group | 303 106 | 58(19.14) 6(5.66) | 109(35.67) 32(30.19) | 83(27.39) 49(46.23) | 48(15.84) 19(17.93) | 167(55.12) 38(35.85) | 250(82.51) 87(82.08) |
Test group and matched group compare: Ridit analyzes: u=3.299 P＜0.001
Illustrate: the clinical total effects of test group and matched group relatively has significant differences.
Two, symptom curative effect
1, two groups of patient's arthralgia treatment front and back curative effects relatively see Table 7.
Curative effect relatively before and after the table 7 liang group patient arthralgia treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 303 106 | 94(31.02) 16(15.09) | 82(27.06) 27(25.47) | 102(33.66) 49(46.23) | 24(7.92) 14(13.21) |
Test group and matched group compare: Ridit analyzes: u=3.426 P＜0.001
Illustrate: test group and matched group improve the arthralgia total effects relatively significant differences.
2, two groups of patient's arthroncus treatment front and back curative effects relatively see Table 8.
Curative effect relatively before and after the table 8 liang group patient arthroncus treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 255 90 | 61(23.92) 21(23.33) | 53(20.78) 17(18.89) | 92(36.08) 26(28.89) | 48(18.82) 26(28.89) |
Test group and matched group compare:
Test group U=1.96 P＞0.05
Illustrate: test group and matched group improve relatively there was no significant difference of arthroncus curative effect.
3, two groups of patient's articular pain treatment front and back curative effects relatively see Table 9.
Curative effect relatively before and after the table 9 liang group patient articular pain treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 293 102 | 99(33.79) 16(15.09) | 61(20.82) 22(21.57) | 98(33.45) 46(45.10) | 35(11.95) 18(17.65) |
Test group and matched group compare, and Ridit analyzes: U=3.29 P＜0.01
Illustrate: test group and matched group improve the articular pain curative effect relatively to be had than significant difference.
4, two groups of patient's joint function disturbance treatment front and back curative effects relatively see Table 10.
Curative effect relatively before and after the table 10 liang group patient joint function disturbance treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 286 98 | 68(23.78) 19(19.39) | 60(20.98) 11(11.23) | 93(32.52) 33(33.67) | 65(22.73) 35(35.71) |
Test group and matched group compare, and Ridit analyzes: U=2.472 P＜0.05
Illustrate: test group and matched group improve the joint function disturbance curative effect relatively significant difference.
5, stiff treatment in morning front and back, two groups of patient joints curative effect relatively sees Table 11.
Curative effect relatively before and after the table 11 liang stiff treatment in group patient joint morning
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 132 43 | 30(22.73) 8(18.61) | 41(31.06) 13(30.23) | 53(40.15) 15(34.88) | 8(6.06) 7(16.280 |
Test group and matched group compare, and Ridit analyzes: U=2.472 P＜.05
Illustrate: test group and matched group improve joint stiff curative effect in morning relatively significant difference.
Three, the curative effect of the two groups of different sick kind treatment of patient front and back relatively.
1. curative effect relatively sees Table 13 before and after the two category rheumatic arthritis patient treatments.
Curative effect relatively before and after the table 13 liang category rheumatic arthritis patient treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effective rate (%) |
| The test group matched group | 119 39 | 26(21.85) 2(5.13) | 40(33.61) 10(25.64) | 38(31.93) 18(46.15) | 15(12.61) 9(23.08) | 87.40 76.92 |
Test group and matched group compare, and Ridit analyzes: U=2.82 P＜0.01
Illustrate: test group and treatment of control group rheumatoid arthritis curative effect relatively have than significant difference.
2. two groups of patients with ankylosing spondylitis treatment front and back curative effects relatively see Table 14.
Curative effect relatively before and after the table 14 liang group patients with ankylosing spondylitis treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effective rate (%) |
| The test group matched group | 53 22 | 9(16.98) 1(4.55) | 20(37.74) 4(18.18) | 12(22.64) 11(50.00) | 12(22.64) 6(27.27) | 77.34 (72.72) |
Test group and matched group compare, and Ridit analyzes: U=1.927 P＞.05
Illustrate: the scorching curative effect of test group and treatment of control group rigid spine is there was no significant difference relatively.
3. two groups of osteoarthritis patient treatment front and back curative effects relatively see Table 15
Curative effect relatively before and after the table 15 liang group osteoarthritis patient treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effective rate (%) |
| The test group matched group | 97 45 | 17(17.53) 6(13.33) | 35(36.08) 9(20.00) | 27(27.83) 25(55.56) | 8(8.25) 6(11.11) | 79(81.44) 41(88.89) |
Test group and matched group compare, and Ridit analyzes: U=2.1997 P＜.05
Illustrate: test group and treatment of control group osteoarthritis curative effect relatively have than significant difference.
Four, the two groups of main laboratory indexes treatment of patient front and back curative effects relatively.
1. curative effect relatively sees Table 16 before and after the erythrocyte sedimentation rate treatment
Curative effect compares X ± S before and after the treatment of table 16 erythrocyte sedimentation rate
| Group | The example number | Before the treatment | After the treatment | P |
| The test group matched group | 194 60 | 44.14±7.09 35.98±7.10 | 20.20±9.13 18.82±6.71 | ＜0.01 ＜0.05 |
Illustrate that test group relatively has than significant difference before and after reducing erythrocyte sedimentation rate self; Significant difference is relatively arranged before and after the matched group self; Test group is comparing there was no significant difference with matched group aspect the reduction erythrocyte sedimentation rate curative effect.
2.C curative effect relatively sees Table 17 before and after the reactive protein treatment.
Curative effect relatively before and after the treatment of table 17C reactive protein
| Group | The example number | Before the treatment | After the treatment | Negative conversion rate | P | ||
| Negative | Positive | Negative | Positive | ||||
| The test group matched group | 104 31 | 35 9 | 69 22 | 55 14 | 49 17 | 17.31％ 16.13％ | ＜0.001 ＜0.001 |
Illustrate: significant differences is relatively arranged before and after the test group self; Significant differences is relatively arranged before and after the matched group self; Test group is comparing there was no significant difference with matched group aspect the reduction c reactive protein curative effect.
3. curative effect relatively sees Table 18 before and after the treatment of rheumatoid arthritis patients rheumatoid factor
Curative effect relatively before and after the treatment of table 18 rheumatoid factor
| Group | The example number | Before the treatment | After the treatment | Negative conversion rate | P | ||
| Negative | Positive | Negative | Positive | ||||
| The test group matched group | 111 33 | 17 6 | 94 27 | 53 11 | 58 22 | 32.43％ 15.15％ | ＜0.001 ＜0.001 |
Illustrate: significant differences is relatively arranged before and after the test group self; Significant differences is relatively arranged before and after the matched group self; Test group is comparing there was no significant difference with matched group aspect the reduction rheumatoid factor curative effect.
Safety detects
In clinical trial, whole experimenters have been carried out the safety detection, the results are shown in Table 20.
Table 20 experimental group patient safety detects
| Project | The example number | Before the treatment | After the treatment | ||
| Normally | Unusually | Normally | Unusually | ||
| Routine blood test routine urinalysis stool routine examination GPT BUN Cr electrocardiogram | 234 234 234 229 229 229 222 | 231 233 230 229 229 229 215 | 3 1 4 0 0 0 7 | 233 234 233 229 229 229 215 | 1 0 1 0 0 0 7 |
Untoward reaction
Do not have
Discuss
The rheumatoid arthritis sheet is made up of medicines such as giving birth to Radix Rehmanniae Preparata, Rhizoma Drynariae, Herba Epimedii, Radix Angelicae Pubescentis, Ramulus Cinnamomi, Flos Carthami, and full side has invigorating the liver and kidney, bone and muscle strengthening, wind-damp dispelling, the effect of the meridian dredging, the adaptation syndrome of this medicine is Liver and kidney two deficiency syndrome, cure mainly arthroncus, distortion, joint stuffiness, ankylosis, wasting and atrophy of muscle, row step difficulty, with soreness of the waist and knees, aversion to cold and preference for warmth, hands and feet being not warm, pale tongue with white fur or whiten, deep-thready pulse or fine and smooth.We in strict accordance with above-mentioned standard, have carried out the III clinical trial phase in clinical, the III clinical trial phase is the result show:
1, two groups of total effectses are compared: test group 326 examples, and above 135 examples of produce effects, obvious effective rate is 41.41%; Effective 157 examples, effective percentage are 48.16%; Total effective rate is 89.57%.Matched group 106 examples, above 135 examples of produce effects, obvious effective rate is 35.85%; Effective 49 routine effective percentage are 46.23%; Total effective rate is 82.08%.Two groups of medicine total effectses are compared, u=3.299 P＜0.001.Illustrate that its curative effect is better than matched group with rheumatoid arthritis sheet treatment rheumatism.
2, arthralgia, swelling, handicapped improvement are compared: test group and matched group improve the arthralgia total effects relatively, and there is significant differences P＜0.001; Test group and matched group improve arthroncus, P＞0.05, there was no significant difference; Test group and matched group improve the joint function disturbance curative effect relatively, and there is significant difference P＜0.05.To improving stiff curative effect comparison P＜0.05 in morning, significant difference is arranged.
3, improvement is compared to lab index such as erythrocyte sedimentation rate, reactive protein, rheumatoid factor: test group is comparing there was no significant difference with matched group aspect the reduction erythrocyte sedimentation rate curative effect.
4, single sick to treating each: test group and treatment of control group rheumatoid arthritis curative effect be P＜0.01 relatively, has than significant difference.Test group and treatment of control group ankylosing spondylitis inflammation curative effect compare, P＞0.05 there was no significant difference.Test group and treatment of control group osteoarthrosis curative effect relatively have significant difference in P＜0.05.
Above result shows that the rheumatoid arthritis sheet has the effect of invigorating the liver and kidney, bone and muscle strengthening, removing obstruction in the collateral to relieve pain really, and best to the rheumatoid therapeutic effect, osteoarthritis is taken second place.
The rheumatoid arthritis sheet does not have obvious adverse reaction, and the heart, liver, kidney, hemogram etc. are all had no adverse effects, and in present oral dose, course of treatment scope, drug safety has no side effect, and is a kind of safe and effective medicine that rheumatism belongs to Liver and kidney two deficiency syndrome for the treatment of.
Test unit:
Guang-amen Hospital, China Traditional Chinese Medicine Instl
Shanghai brilliance hospital
Shanghai City institute of traditional Chinese medicine
Henan rheumatism hospital
Luoyang bonesetting hospital
The Beijing Jishuitan Hospital
Hospital Attached to Liaoning Inst. of Traditional Chinese Medicine
Gansu Provincial Hospital of Traditional Chinese Medicine
Tangshan City institute of traditional Chinese medicine
The Provincial Medicine Research Institute, Gansu
Benxi Hospital of Traditional Chinese Medicine
Claims (22)
1. Chinese medicine for the treatment of rheumatoid arthritis is characterized in that it is prepared from by acceptable auxiliary on following weight parts proportion raw material and the pharmaceutics:
Radix Rehmanniae 160-280 Radix Rehmanniae Preparata 160-280 Radix Dipsaci 120-210
Radix Aconiti Lateralis Preparata 120-210 Radix Angelicae Pubescentis 80-140 Rhizoma Drynariae 120-210
Ramulus Cinnamomi 80-140 Herba Epimedii 120-210 Radix Saposhnikoviae 80-140
Radix Clematidis 120-210 Spina Gleditsiae 80-140 Os Caprae seu Ovis 160-280
Radix Paeoniae Alba 96-168 system Rhizoma Cibotii 120-210 Rhizoma Anemarrhenae 120-210
Herba Lycopodii 80-140 Flos Carthami 80-140.
2. Chinese medicine according to claim 1 is characterized in that the weight portion of raw material is:
Radix Rehmanniae 235.3 Radix Rehmanniaes Preparata 235.3 Radix Dipsacis 176.5
Radix Aconiti Lateralis Preparata 176.5 Radix Angelicae Pubescentiss 117.7 Rhizoma Drynariae 176.5
Ramulus Cinnamomi 117.7 Herba Epimedii 176.5 Radix Saposhnikoviaes 117.7
Radix Clematidis 176.5 Spina Gleditsiaes 117.7 Os Caprae seu Ovis 235.3
The Radix Paeoniae Alba 141.2 system Rhizoma Cibotii 176.5 Rhizoma Anemarrhenaes 176.5
Herba Lycopodii 117.7 Flos Carthamis 117.7.
3. Chinese medicine according to claim 1 is characterized in that the weight portion of raw material is:
Radix Rehmanniae 170 Radix Rehmanniaes Preparata 180 Radix Dipsacis 130
Radix Aconiti Lateralis Preparata 130 Radix Angelicae Pubescentiss 140 Rhizoma Drynariae 140
Ramulus Cinnamomi 90 Herba Epimedii 130 Radix Saposhnikoviaes 100
Radix Clematidis 130 Spina Gleditsiaes 90 Os Caprae seu Ovis 170
The Radix Paeoniae Alba 105 system Rhizoma Cibotii 130 Rhizoma Anemarrhenaes 130
Herba Lycopodii 100 Flos Carthamis 100.
4. Chinese medicine according to claim 1 is characterized in that the weight portion of raw material is:
Radix Rehmanniae 280 Radix Rehmanniaes Preparata 260 Radix Dipsacis 200
Radix Aconiti Lateralis Preparata 190 Radix Angelicae Pubescentiss 130 Rhizoma Drynariae 180
Ramulus Cinnamomi 140 Herba Epimedii 195 Radix Saposhnikoviaes 120
Radix Clematidis 190 Spina Gleditsiaes 125 Os Caprae seu Ovis 270
The Radix Paeoniae Alba 155 system Rhizoma Cibotii 195 Rhizoma Anemarrhenaes 200
Herba Lycopodii 120 Flos Carthamis 120.
5. Chinese medicine according to claim 1 is characterized in that the weight portion of raw material is:
Radix Rehmanniae 180 Radix Rehmanniaes Preparata 160 Radix Dipsacis 130
Radix Aconiti Lateralis Preparata 130 Radix Angelicae Pubescentiss 140 Rhizoma Drynariae 200
Ramulus Cinnamomi 110 Herba Epimedii 190 Radix Saposhnikoviaes 130
Radix Clematidis 130 Spina Gleditsiaes 125 Os Caprae seu Ovis 260
The Radix Paeoniae Alba 150 system Rhizoma Cibotii 180 Rhizoma Anemarrhenaes 180
Herba Lycopodii 120 Flos Carthamis 120.
6. according to the arbitrary described Chinese medicine of claim 1-5, it is characterized in that: adjuvant wherein is starch, lactose, dextrin, betacyclodextrin, magnesium stearate, Pulvis Talci, aspartame, crosslinked polyethylene pyrrole Lip river alkane ketone, crosslinked poly-carmethose, stevioside, micropowder silica gel, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, castor oil hydrogenated, sodium stearyl fumarate, PEG-6000 or carboxymethyl starch sodium.
7. according to the arbitrary described Chinese medicine of claim 1-5, it is characterized in that: this Chinese medicine is capsule, pellet capsule, soft capsule or dispersible tablet.
8. preparation method of Chinese medicine according to claim 7 is characterized in that comprising the following steps:
Get above ten seven flavor medicine materials, decoct with water twice, decocted 1-4 hour for the first time, decocted 1-4 hour for the second time.Collecting decoction filters, and the relative density of surveying when filtrate is concentrated into 25-50 ℃ is the clear paste of 1.10-1.25.Qinghuo reagent adds the adjuvant spray granulation, the choosing grain, and filling is prepared into capsule, promptly.
9. preparation method of Chinese medicine according to claim 7 is characterized in that comprising the following steps:
Get above ten seven flavor medicine materials, decoct with water twice, decocted 1-4 hour for the first time, decocted 1-4 hour for the second time.Collecting decoction filters, and the relative density of surveying when filtrate is concentrated into 25-50 ℃ is the clear paste of 1.10-1.25.Qinghuo reagent adds adjuvant, the preparation micropill, and drying, coating, capsule charge, promptly.
10. Chinese medicine according to claim 7 is characterized in that it is prepared from as follows:
Get above ten seven flavor medicine materials, decoct with water 2-3 time, each 1-4 hour, collecting decoction, filter, filtrate is concentrated into fluid extract, puts coldly, adds ethanol and makes the medicinal liquid concentration of alcohol reach 50%-80%, stand at low temperature 12-24 hour, get supernatant concentration to fluid extract, the spray drying powder that gets dry extract.This dried cream powder is added proper auxiliary materials or solvent gets content, with pellet press with content-filled, be pressed in the soft capsule shell, promptly get soft capsule by washing operations such as ball, drying, packing then.
11. soft capsule according to claim 10 is characterized in that: the softgel shell of this soft capsule preparation consists of one or more in gelatin, glycerol, sorbitol, PEG-400, water, methyl parahydroxybenzoate, propyl p-hydroxybenzoate, sodium pyrosulfite or the food coloring.
12. soft capsule according to claim 10 is characterized in that: content substrate is one or more among crude vegetal, PEG-400, PEG-6000, tween 80, glycerol, propylene glycol, Cera Flava, PVP, HPMC, CMC, PVA or the EC.
13. soft capsule according to claim 10 is characterized in that: the ratio of principal agent and substrate is 1: 0.5-10.
14. Chinese medicine according to claim 7 is characterized in that it makes by following preparation method:
Get above ten seven flavor medicine materials, decoct with water 2-3 time, each 1-4 hour, collecting decoction filtered, filtrate simmer down to fluid extract, put coldly, add ethanol and make the medicinal liquid concentration of alcohol reach 50%-80%, stand at low temperature 8-24 hour, get supernatant concentration to clear paste, gained clear paste and proper auxiliary materials are prepared into the rheumatoid arthritis dispersible tablet.
15. Chinese medicine according to claim 7 is characterized in that it makes by following preparation method: with the clear paste spray drying of the claim 14 preparation powder that gets dry extract, this dried cream powder is sieved, add proper auxiliary materials, mixing, direct compression.
16. Chinese medicine according to claim 7 is characterized in that it makes by following preparation method: the clear paste of claim 14 preparation is added after adjuvant granulates, and granulate, tabletting are promptly.
17. Chinese medicine according to claim 14 is characterized in that: used adjuvant comprises filler, disintegrating agent, fluidizer and lubricant.
18. Chinese medicine according to claim 14 is characterized in that: the ratio of principal agent, filler, disintegrating agent, fluidizer, lubricant is 5-80: 5-40: 10-20: 0-10: 0-1.
19. Chinese medicine according to claim 17, it is characterized in that: filler is lactose or microcrystalline Cellulose, disintegrating agent is carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crosslinked polyethylene pyrrole Lip river alkane ketone or crosslinked poly-carmethose, fluidizer is a silica sol, and lubricant is Pulvis Talci, magnesium stearate, castor oil hydrogenated, sodium stearyl fumarate or PEG-6000.
20. according to claim 14,15 or 16 described Chinese medicines, it is characterized in that made tablet for coating not or coating.
21. Chinese medicine according to claim 20 is characterized in that coating is a film-coat, the thin film dress material is complete water-soluble matchmaker or pure water-soluble matchmaker.
22. the application of the arbitrary described Chinese medicine of claim 1-5 in the medicine of preparation treatment rheumatoid arthritis.
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