CN100534450C - Chinese medicinal formulation for treating rheumatic and rheumatoid arthritis and preparation process thereof - Google Patents
Chinese medicinal formulation for treating rheumatic and rheumatoid arthritis and preparation process thereof Download PDFInfo
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- CN100534450C CN100534450C CNB2005100224944A CN200510022494A CN100534450C CN 100534450 C CN100534450 C CN 100534450C CN B2005100224944 A CNB2005100224944 A CN B2005100224944A CN 200510022494 A CN200510022494 A CN 200510022494A CN 100534450 C CN100534450 C CN 100534450C
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- rheumatoid arthritis
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Abstract
The invention discloses a Chinese medicinal preparation and process for preparing same, wherein the preparation can be used for treating rheumatoid arthritis and is prepared from (by weight ratio) Japanese yam 800-930 and astragalus root 70-120 through steps of drying at 80-90 deg C, through 100 mesh sieves, mixing homogeneously, loading into capsules, and carrying out radiation sterilization.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation, the particularly a kind of Rhizoma Dioscoreae Nipponicae and Radix Astragali of adopting is Chinese medicine preparation of raw material for treating rheumatic and rheumatoid arthritis and preparation method thereof.
Background technology:
(rheumatoid arthritis is modal inflammatory arthritis RA) to rheumatoid arthritis, accounts for 1% of world's total population.China's prevalence is about 0.3%.Think that now RA is a kind of autoimmune disease, it is articular synovitis that its basic pathology changes, and acute stage synovial membrane swelling, oozes out, neutrophil infiltration, synovial hyperplasia plumpness, forms pannus.Proliferation of fibrous tissue in the pannus is invaded in the osteochondral tissue, cause osseous tissue inflammation, necrosis and fibrous connective tissue hypertrophy, calcification then takes place fibroid and bone arthrosclerosis occur, significantly narrow or complete obiteration of articular cavity brings very big misery to patient.Rheumatoid arthritis belongs to Chinese medical ' arthralgia syndrome ' category.Primary disease is many because of battalion's deficiency of defensive qi, and not solid in the natural fibre line of meat, the damp of having a cold again causes due to the passages through which vital energy circulates QI and blood impatency.
At present, generally adopt glucocorticoid to treat rheumatoid arthritis, but drug effect is balanced inadequately lasting, using hormone therapy does not have obvious improvement to RA joint deformity, swelling, and the toxic and side effects of hormone, and digestive tract is stimulated obviously, bigger to the hepatic and renal function influence, knock-on and recurrence easily after the drug withdrawal.
At present, though the report of pair Rhizoma Dioscoreae Nipponicae treatment rheumatic arthritis and coronary heart disease is also arranged, do not see that adopting the Rhizoma Dioscoreae Nipponicae and the Radix Astragali is that raw material is treated rheumatoid arthritis.
Summary of the invention:
The purpose of this invention is to provide a kind of Rhizoma Dioscoreae Nipponicae and Radix Astragali of adopting is Chinese medicine preparation of raw material for treating rheumatic and rheumatoid arthritis and preparation method thereof.
Concrete technical scheme of the present invention is as follows:
A kind of Chinese medicine preparation for the treatment of rheumatic and rheumatoid arthritis is characterized in that: formulated according to weight proportion by following component: Rhizoma Dioscoreae Nipponicae 800～930 weight portions, the Radix Astragali 70～120 weight portions.
Preparation method of the present invention is as follows: Rhizoma Dioscoreae Nipponicae and the choosing of Radix Astragali crude drug are weighed according to above-mentioned weight proportion only, and after oven dry under 80～90 ℃, pulverize separately is crossed the above sieve of 100 orders, remix is even, be the pale brown toner end of bitter in the mouth, incapsulate, make finished product through radiation sterilization.
Rhizoma Dioscoreae Nipponicae of the present invention has another name called Dioscorea nipponica Mak. Ningpo Yam Rhizome, dioscorea japonica etc., is Dioscoreaceae plant Dioscorea nipponica Mak. Ningpo Yam Rhizome (Dioscorea nipponica Makino) rhizome.Flavor: sweet, bitter, warm in nature.Energy wind-damp dispelling, relieving pain and activating blood circulation Shujin, relieving cough and asthma eliminate the phlegm.Be used for rheumatic arthritis, lumbago and skelalgia, numbness, Kaschin-Beck disease, traumatic injury, lumbar sprain and QI divergeny, chronic bronchitis, cough and asthma [1].Contain dioscin multiple steroidal saponins such as (dioscin).The total saponins hydrolysis produces diosgenin (diosgenin), and its content is about 1.5%～2.6%.Still contain a spot of 25-D-spiral shell steroid-3 in the rhizome, and the 5-diene (25-D-Spirosta-3,5-diene), with wind-damp dispelling, relieving pain and activating blood circulation Shujin merit work.Rhizoma Dioscoreae Nipponicae is put down in writing at " Shandong Chinese medicine " the treatment of rheumatoid arthritis: " control anemofrigid-damp arthralgia." " Shaanxi Chinese herbal medicine " meaning: " treating rheumatic arthritis." " the northeast medicine is planted will ": " relaxing muscles and tendons to promote blood circulation is controlled lumbago and skelalgia, the muscles and bones numbness.”
The Radix Astragali of the present invention has tonifying Qi and lifting yang, benefit is defended consolidating superficial resistance, the effect of diuretic detumescent.Be applicable to numb limbs and tense tendons, arthralgia, hemiplegia due to the blood stagnancy due to deficiency of QI; The disease such as disappear of deficiency of vital energy body fluid deficiency.
End product quality standard of the present invention meets the relevant every regulation under capsule item of Pharmacopoeia of the People's Republic of China version in 2005.
Finished product of the present invention stores points for attention: airtight, be placed on shady and cool shading place.
Function of the present invention cures mainly: wind-damp dispelling, pain relieving, relaxing muscles and tendons to promote blood circulation, adjusting body's immunity.Be used for redness and swelling of joints that a variety of causes such as rheumatoid, rheumatic arthritis, ankylosing spondylitis, rheumatic myalgia cause, pain, stiff, deformity etc.
The storage life of finished product of the present invention is 2 years.Finished product usage and dosage of the present invention: oral.Be grown up 1 2～3/0.40g/ grain, the airtight shady and cool drying place that is placed on 3 times on the 1st.Child, anemia of pregnant woman and women breast-feeding their children avoid usefulness.
It is Main Ingredients and Appearance that the present invention adopts with the Rhizoma Dioscoreae Nipponicae, and simple for production, patient's taking convenience has no side effect, and therapeutic effect is obvious and reliable, can for a long time or be interrupted and use, and good prospects for application is arranged.
The present invention and glucocorticoid relatively have the following advantages:
1, drug effect is balanced lasting, does not have the toxic and side effects of hormone, can in the middle of drug withdrawal, not knock-on after the drug withdrawal;
2, to digestive tract without any stimulation;
3, using hormone therapy does not have obvious improvement to RA joint deformity, swelling, finds that in clinical practice medicine of the present invention can make the odd-shaped joint of swelling obviously subside a swelling, and makes joint function recovery normal;
4, hepatic and renal function there is not influence.
The specific embodiment:
Embodiment 1
A kind of Chinese medicine preparation for the treatment of rheumatic and rheumatoid arthritis, by Rhizoma Dioscoreae Nipponicae 900g, Radix Astragali 100g is formulated, and the glue capsule is 2500 altogether.Every granule 0.40g.
Preparation method of the present invention is as follows: Rhizoma Dioscoreae Nipponicae and the choosing of Radix Astragali crude drug are weighed according to proportioning only, and after oven dry under 80 ℃, pulverize separately is crossed 100 purposes sieve, and remix is even, is the pale brown toner end of bitter in the mouth, incapsulates, and makes through radiation sterilization.
Embodiment 2
A kind of Chinese medicine preparation for the treatment of rheumatic and rheumatoid arthritis, by Rhizoma Dioscoreae Nipponicae 800g, Radix Astragali 120g is formulated, and the glue capsule is 2300 altogether.Every granule 0.40g.
Preparation method of the present invention is as follows: Rhizoma Dioscoreae Nipponicae and the choosing of Radix Astragali crude drug are weighed according to proportioning only, and after oven dry under 90 ℃, pulverize separately is crossed 150 purposes sieve, and remix is even, is the pale brown toner end of bitter in the mouth, incapsulates, and makes through radiation sterilization.
Embodiment 3
A kind of Chinese medicine preparation for the treatment of rheumatic and rheumatoid arthritis, by Rhizoma Dioscoreae Nipponicae 930g, Radix Astragali 70g is formulated, and the glue capsule is 2500 altogether.Every granule 0.40g.
Preparation method of the present invention is as follows: Rhizoma Dioscoreae Nipponicae and the choosing of Radix Astragali crude drug are weighed according to proportioning only, and after oven dry under 85 ℃, pulverize separately is crossed 200 purposes sieve, and remix is even, is the pale brown toner end of bitter in the mouth, incapsulates, and makes through radiation sterilization.
Embodiment 4
A kind of Chinese medicine preparation for the treatment of rheumatic and rheumatoid arthritis, by Rhizoma Dioscoreae Nipponicae 850g, Radix Astragali 100g forms, and the glue capsule is 2375 altogether.Every granule 0.40g.
Preparation method of the present invention is as follows: Rhizoma Dioscoreae Nipponicae and the choosing of Radix Astragali crude drug are weighed according to proportioning only, and after oven dry under 80 ℃, pulverize separately is crossed 120 sieve, and remix is even, is the pale brown toner end of bitter in the mouth, incapsulates, and makes through radiation sterilization.
Embodiment 5
The survey report of finished product of the present invention is as follows:
Inspection item standard code testing data project conclusion
[character] this product is a capsule.Content is up to specification
Pale brown toner end, bitter in the mouth.
[discriminating]
(1) should being positive reaction, to be positive reaction up to specification
(2) should being positive reaction, to be positive reaction up to specification
[inspection]
It is 9.0% 1.4% up to specification that moisture is no more than
Content uniformity should be up to specification up to specification
Disintegration should be up to specification up to specification
Microbial limit
Escherichia coli should be up to specification up to specification
Live demodicid mite and ovum do not have do not detect up to specification
Total number of bacteria＜10000/g＜10000/g is up to specification
Total number of molds＜100/g＜10/g is up to specification
Conclusion: meet relevant every regulation under an appendix capsule of Pharmacopoeia of the People's Republic of China version in 2005 item.
Embodiment 6
The present invention treats rheumatoid arthritis 60 routine observation of curative effect and is summarized as follows:
The clinical over thousands of example of treatment that is used for rheumatoid arthritis has obtained better curative effect, does not see obvious adverse reaction, now recent clinical observation 60 examples is analyzed as follows:
1 data and method
1.1 clinical data
All cases are outpatient service rheumatoid arthritis example during in November, the 2004～2005 year JIUYUE.Wherein male 19 examples, women 41 examples; 30～77 years old age, 54 years old mean age.Course of disease February～40 year.
1.2 case choice criteria
1.2.1 diagnostic criteria (according to " clinical disease diagnosis is cured the improvement standard ")
Have 4 in following 7,1～4 palpus continued more than 6 weeks.
(1) morning deadlock 〉=1h.
(2) arthritis 〉=3 hinge area.
(3) () joints of hand (carpal joint, metacarpophalangeal joints, proximal phalangeal joints) is got involved.
(4) symmetrical joint involvement.
(5) rheumatoid nodules.
(6) rheumatoid factor exists, and the inspection method of employing is at normal person's positive rate＜5%.
(7) X line hand photo bone erosion or sure sclerotin decalcification.
1.2.2 experiment case standard
1.2.2.1 include the case standard in
Allly meet the primary disease diagnostic criteria and remove every person in following " getting rid of the case standard " side by side, all can include the test case in.
1.2.2.2 get rid of case standard (comprising inadaptation or rejecting standard)
(1) is associated with serious primary disease person such as cardiovascular, liver, kidney and hemopoietic system, psychotic.
(2) take salicylic acid anti-inflammatory agent, antimalarial, golden preparation, cytotoxicity medicine, glucocorticoid and immune formulation person simultaneously.
(3) not medication in accordance with regulations can't be judged that curative effect or data are not congruent to affect the treatment or safety judgement person.
1.3 observation index
1.3.1 safety observation
(1) general symptom and sign.
(2) blood, urine, just routine examination.
(3) heart, liver, kidney merit.
1.3.2 health giving quality observation
(1) symptom: arthralgia, morning deadlock.
(2) sign: arthroncus, joint deformity, range of motion, rheumatoid nodules.
(3) lab testing: erythrocyte sedimentation rate, rheumatoid factor, X-ray film.
1.4 curative effect determinate standard (with reference to " clinical disease diagnosis is cured the improvement standard ")
Produce effects: the arthralgia complete obiteration, joint deformity and functional rehabilitation, erythrocyte sedimentation rate reduces, and rheumatoid factor is turned out cloudy.
Take a turn for the better: arthralgia alleviates, and function is recovered substantially, and erythrocyte sedimentation rate is normal or slightly higher, and rheumatoid factor is turned out cloudy.
Invalid: symptom, sign do not have improvement or increase the weight of, the constant or rising of erythrocyte sedimentation rate, and rheumatoid factor is not turned out cloudy.
1.5 Therapeutic Method
Every day, oral capsule 3.6～4.8g of the present invention divided three administrations.1～3 month course of treatment, the longest is 2 years.
2, result
23 routine produce effects, obvious effective rate 38.3%, 25 example takes a turn for the better improvement rate 41.7%, total effective rate 80%.Do not see that untoward reaction takes place.
Embodiment 7
With reference to " new drug clinical before safety evaluatio with put into practice " carry out acute toxicity test, as follows:
Finished product product content of the present invention is the crude drug in whole powder.In Cmax, maximum permissible dose (MPD), fail to obtain its LD
50So, can only measure its maximum tolerated dose.
1. animal is got some of Kunming kind healthy mices, body weight 18-22g (in average 20g), and fasting 12 hours, standby.
2. route of administration and method
2.1 route of administration
Make suspension (every ml is equivalent to protogenic medicinal powder 0.50g), mouse stomach administration with capsule 's content granule of the present invention.
2.2 method and result
This product is with Cmax (every ml is equivalent to protogenic medicinal powder 0.50g), maximum permission capacity 2ml.Give 20 the disposable gastric infusion of mice capsule content of the present invention powder suspension 1ml, observed continuously 7--14 days, do not have 1 death.Recording its maximum tolerated dose is 25.00g/kg.
Model case
Case 1 Zhao * *, the woman, 54 years old, the hospital laboratory retired cadre joint deadlock in morning occurred in 1997, and pain when walk in right toes joint is checked the rheumatoid factor positive.Once took 2 bottles of Tripterygium hypoglaucumes, because of causing stomach discomfort, withdrawal.The check rheumatoid factor positive, anti-" O " feminine gender, the c reactive protein positive.August in this year, conscious joint deadlock in morning obviously increased the weight of 〉=1h, and the biped toe joint has migration pain, checked the rheumatoid factor positive, and anti-" O " is weak positive, the c reactive protein positive, erythrocyte sedimentation rate 85mm/h.Give capsule 1.2g of the present invention, 2/ oral, 1 month course of treatment, 1 all posterior joints stiff disappearance the in morning that begin to take medicine, symptom complete obiteration such as posterior joint pain in January.The check rheumatoid factor negative, anti-" O " feminine gender, c reactive protein feminine gender, erythrocyte sedimentation rate 42mm/h.Do not occur repeatedly after the drug withdrawal.
Case 2 Lee * *, the woman is 63 years old, married.Began to occur not holding little joint migration pain in 93 years, companion's arthroncus deformity, morning symptom such as deadlock, overcast and rainy increasing the weight of, the difficulty of taking care of oneself, outbreak repeatedly in several years.In February, 2005, above-mentioned symptom increased the weight of, whole body arthralgia, influence sleep; Bed, standing up wears the clothes all can not finish voluntarily, and continuous the reaching more than the 6h of refusing to budge morning come my institute.Have a medical check-up: extremities joint is symmetrical swelling, and the little joint of near-end, the right second metacarpophalangeal joints swelling are obvious, can touch subcutaneous nodule, bed, and it is limited to walk.Auxiliary examination: the rheumatoid factor positive, the c reactive protein positive, anti-" O " positive, erythrocyte sedimentation rate 60mm/h, the report of X ray examination: two carpal joint carpal bones and metacarpophalangeal joints bone destruction, deformity, two carpal joint gap and metacarpophalangeal joints gap turn narrow merge, hypertrophy.Give capsule 1.2g of the present invention, 3/ oral, and pain symptom begins to alleviate after beginning to take medicine 3 days, and morning, deadlock alleviated, check erythrocyte sedimentation rate 25mm/h.One all posterior joint pain and morning, stiff symptom was obviously alleviated, and did not have significant discomfort at level walking.Do not have stiff phenomenon in obvious morning 10 day day after tomorrow, at level walking freely, life can take care of oneself substantially, and the swelling of bilateral palm alleviates, and the metacarpophalangeal joints limited degree obviously alleviates, and joint deformity improves.
Claims (5)
1, a kind of Chinese medicine preparation for the treatment of rheumatoid arthritis is characterized in that: formulated according to weight proportion by following component: Rhizoma Dioscoreae Nipponicae 800～930 weight portions, the Radix Astragali 70～120 weight portions.
2, a kind of Chinese medicine preparation for the treatment of rheumatoid arthritis according to claim 1, it is characterized in that: by Rhizoma Dioscoreae Nipponicae 900g, Radix Astragali 100g is formulated, and the glue capsule is 2500 altogether, every granule 0.40g.
3, a kind of preparation method for the treatment of the Chinese medicine preparation of rheumatoid arthritis according to claim 1 and 2, it is characterized in that: Rhizoma Dioscoreae Nipponicae and the choosing of Radix Astragali crude drug are weighed according to proportioning only, after oven dry under 80～90 ℃, pulverize separately is crossed the above sieve of 100 orders, remix is even, be the pale brown toner end of bitter in the mouth, incapsulate, make finished product through radiation sterilization.
4, a kind of preparation method for the treatment of the Chinese medicine preparation of rheumatoid arthritis according to claim 3, it is characterized in that: Rhizoma Dioscoreae Nipponicae and the choosing of Radix Astragali crude drug are weighed according to proportioning only, after oven dry under 80 ℃, pulverize separately is crossed 100 purposes sieve, remix is even, be the pale brown toner end of bitter in the mouth, incapsulate, make finished product through radiation sterilization.
5, a kind of Chinese medicine preparation for the treatment of rheumatoid arthritis according to claim 1 and 2, it is characterized in that: the usage and dosage of this Chinese medicine preparation is: oral, the 0.8～1.2g that is grown up a time, three times on the one.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100224944A CN100534450C (en) | 2005-12-31 | 2005-12-31 | Chinese medicinal formulation for treating rheumatic and rheumatoid arthritis and preparation process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100224944A CN100534450C (en) | 2005-12-31 | 2005-12-31 | Chinese medicinal formulation for treating rheumatic and rheumatoid arthritis and preparation process thereof |
Publications (2)
| Publication Number | Publication Date |
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| CN1994358A CN1994358A (en) | 2007-07-11 |
| CN100534450C true CN100534450C (en) | 2009-09-02 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB2005100224944A Expired - Fee Related CN100534450C (en) | 2005-12-31 | 2005-12-31 | Chinese medicinal formulation for treating rheumatic and rheumatoid arthritis and preparation process thereof |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103169834A (en) * | 2011-12-21 | 2013-06-26 | 北京中医药大学东直门医院 | Traditional Chinese medicine composition for treating refractory thrombocytopenia |
| CN105535752A (en) * | 2016-01-15 | 2016-05-04 | 吕富冉 | Chinese herb preparation for treating rheumatoid arthritis and nursing method |
| CN108514598B (en) * | 2018-04-02 | 2021-08-17 | 黄清春 | Composition for preventing and/or treating rheumatoid arthritis and preparation and application thereof |
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Granted publication date: 20090902 Termination date: 20100201 |