CN102657736B - Medicament composition for treating rheumatoid arthritis and preparation method of medicament composition - Google Patents
Medicament composition for treating rheumatoid arthritis and preparation method of medicament composition Download PDFInfo
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Abstract
The invention discloses a medicament composition for treating rheumatoid arthritis. The active pharmaceutical ingredients for preparing the medicament composition for treating the rheumatoid arthritis include, by weight, 50-150 parts of ovientvine, 50-150 parts of common threewingnut root, 50-150 parts of epimedium, 50-150 parts of large-leaved gentian, 100-200 parts of caulis spatholobi, 100-200 parts of root of red-rooted salvia, 50-150 parts of corydalis tuber, 100-200 parts of astragalus mongholicus, 50-150 parts of rehmannia, 50-150 parts of white paeony root, 50-150 parts of Chinese rhubarb, 50-150 parts of baical skullcap root and 10-150 parts of licorice root. A preparation method of the medicament composition includes steps of weighting the active pharmaceutical ingredients according to the formulas, evenly mixing the active pharmaceutical ingredients by grinding, extracting water and concentrating or the combination of the both, and then obtaining the medicament composition. The medicament composition for treating the rheumatoid arthritis is capable of dispelling the wind, detoxicating, dredging collaterals, reinforcing qi, nourishing blood and strengthening body resistance, and is used for treating the rheumatoid arthritis, ankylosing spondylitis and muscle pains, swell, limited motion and the like caused by other rheumatism immunological diseases.
Description
Technical field
The present invention relates to technical field of pharmaceuticals, especially a kind ofly take the pharmaceutical preparation for the dispelling toxins and dredging collaterals that dispels the wind, benefiting QI and nourishing blood righting that vegetable Chinese herbal medicine makes as raw material, the pain of joint muscle causing for rheumatoid arthritis, ankylosing spondylitis and other rheumatism immune diseases, swelling, limitation of activity etc., be particularly useful for sports medical science; The invention still further relates to the preparation method of this pharmaceutical preparation.
Background technology
Diffuse Connective Tissue Disease in modern medicine all matches with the dirty arthromyodynia of body of the traditional Chinese medical science as rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus (sle), dermatomyositis, systemic sclerosis, systemic vasculitis, dry syndrome, behcets disease etc.The traditional Chinese medical science think the etiology and pathogenesis of arthromyodynia mainly obstructed with the evil malicious numbness choke blood such as the wind, cold, wet of diseases caused by exogenous pathogenic factor or interior life, heat, dry, silt, venation due to.Clinical have card partially cold, partial heat because feeling evil different in kind and body constitution from change, but be many in state of an illness active stage partial heat or intermingling cold and heat.Treatment is worked as with expelling wind and removing dampness, and dispelling toxins and dredging collaterals is main method.
Raising along with modern medical service technology, the immune disease sickness rate such as rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus (sle), dermatomyositis are in rising trend, and this type of disease needs Long-term taking medicine, take medicine even all the life, doctor trained in Western medicine is mainly with hormone immunity inhibitor for treating at present, side effect is large, and increases the weight of patient's financial burden.
Radix Tripterygii Wilfordii from 1969 domestic be applied to first to treat rheumatoid arthritis since, experience a large amount of clinical experimental research of 27 years, confirming to have significantly specific antiinflammatory and suppressing is main immunoregulation effect and the effect of parahormone sample.For rheumatismal main pharmacology links of autoimmunity such as rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus (sle), dermatomyositis/multiple myositis, scleroderma, it has the triple role of Western medicine nonsteroidal antiinflammatory drug, hormone and immune formulation concurrently, therefore clinical efficacy is remarkable, be regarded as " trump " medicine for Chinese medicine autoimmune disease, two during the last ten years, successively has the multiple dosage forms such as Tripterygium wilfordii Polyglycosidium Tablets, Radix Tripterygii Wilfordii tablet, effect of Triperygium Wilfordii Bilayer Tablets and drop pill, total terpene sheet to be widely used in clinical.But Radix Tripterygii Wilfordii also has obvious shortcoming: the toxicity within the scope of its therapeutic dose is very common, that gives patient has healthyly brought larger adverse effect.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of pharmaceutical composition for the treatment of rheumatoid arthritis, can dispel the wind dispelling toxins and dredging collaterals, benefiting QI and nourishing blood righting, be used for the treatment of pain of joint muscle that rheumatoid arthritis, ankylosing spondylitis and other rheumatism immune diseases cause, swelling, limitation of activity etc.; For this reason, the present invention provides the preparation method of this pharmaceutical composition simultaneously.
For solving the problems of the technologies described above, the technical solution used in the present invention is as follows.
Treat a pharmaceutical composition for rheumatoid arthritis, the main pharmacodynamics raw material of making by ratio of weight and the number of copies this pharmaceutical composition is: Caulis Sinomenii 50～150, Radix Tripterygii Wilfordii 50～150, Herba Epimedii 50～150, Radix Gentianae Macrophyllae 50～150, Caulis Spatholobi 100～200, Radix Salviae Miltiorrhizae 100～200, Rhizoma Corydalis 50～150, the Radix Astragali 100～200, Radix Rehmanniae 100～200, the Radix Paeoniae Alba 50～150, Radix Et Rhizoma Rhei 50～150, Radix Scutellariae 50～150, Radix Glycyrrhizae 10～150.
As a preferred technical solution of the present invention, the main pharmacodynamics raw material of making by ratio of weight and the number of copies this pharmaceutical composition is: Caulis Sinomenii 82～86, Radix Tripterygii Wilfordii 82～86, Herba Epimedii 82～86, Radix Gentianae Macrophyllae 82～86, Caulis Spatholobi 160～175, Radix Salviae Miltiorrhizae 160～175, Rhizoma Corydalis 108～116, the Radix Astragali 160～175, Radix Rehmanniae 160～175, the Radix Paeoniae Alba 82～86, Radix Et Rhizoma Rhei 54～58, Radix Scutellariae 54～58, Radix Glycyrrhizae 54～58.
As a preferred technical solution of the present invention, the main pharmacodynamics raw material of making by ratio of weight and the number of copies this pharmaceutical composition is: Caulis Sinomenii 84, Radix Tripterygii Wilfordii 84, Herba Epimedii 84, Radix Gentianae Macrophyllae 84, Caulis Spatholobi 168, Radix Salviae Miltiorrhizae 168, Rhizoma Corydalis 112, the Radix Astragali 168, Radix Rehmanniae 168, the Radix Paeoniae Alba 84, Radix Et Rhizoma Rhei 56, Radix Scutellariae 56, Radix Glycyrrhizae 56.
As a preferred technical solution of the present invention, the main pharmacodynamics raw material of making by ratio of weight and the number of copies this pharmaceutical composition is: Caulis Sinomenii 85, Radix Tripterygii Wilfordii 85, Herba Epimedii 82, Radix Gentianae Macrophyllae 86, Caulis Spatholobi 170, Radix Salviae Miltiorrhizae 162, Rhizoma Corydalis 110, the Radix Astragali 173, Radix Rehmanniae 174, the Radix Paeoniae Alba 82, Radix Et Rhizoma Rhei 54, Radix Scutellariae 58, Radix Glycyrrhizae 54.
The preparation method of the pharmaceutical composition of above-mentioned treatment rheumatoid arthritis: take each pharmacodynamic raw materials according to above-mentioned formula, by pulverizing, water extraction is concentrated or mode the two combination mixes each pharmacodynamic raw materials, obtain.
As a kind of optimal technical scheme of above-mentioned preparation method, its step comprises:
A, according to above-mentioned formula, take each pharmacodynamic raw materials, wherein Radix Gentianae Macrophyllae, Radix Salviae Miltiorrhizae, Rhizoma Corydalis, the Radix Astragali, the Radix Paeoniae Alba, Radix Glycyrrhizae, Radix Et Rhizoma Rhei, Radix Scutellariae eight taste medicated powder are broken into fine powder;
B, Caulis Sinomenii, Radix Tripterygii Wilfordii, Radix Rehmanniae, Caulis Spatholobi, Herba Epimedii five kinds of Chinese medicine add 6～10 times of water gagings and decoct, and decocting liquid filters, and filtrate is concentrated into the clear paste that relative density is 1.10g/ml～1.20g/ml;
C, steps A gained fine powder is joined in the clear paste of step B, mix, dry, pulverize into fine powder, sieve, obtain.
As a kind of optimal technical scheme of above-mentioned preparation method, every 100g step C gained powder adds water with refined honey 31g～39g and makes water-honeyed pill 1000g, dry, obtains finished product.
As a kind of optimal technical scheme of above-mentioned preparation method, in step B, Caulis Sinomenii, Radix Tripterygii Wilfordii, Radix Rehmanniae, Caulis Spatholobi, Herba Epimedii five kinds of Chinese medicine add 8 times of water gagings and decoct 2～4 times, decoct altogether 2 hours～4 hours, continue subsequent step after collecting decoction.
A kind of optimal technical scheme as above-mentioned preparation method, takes each pharmacodynamic raw materials according to above-mentioned formula, is ground into fine powder, sieves, and every 100g gained powder adds water with refined honey 31g～39g and makes water-honeyed pill 1000g, dry, obtains finished product.
A kind of optimal technical scheme as above-mentioned preparation method, takes each pharmacodynamic raw materials according to above-mentioned formula, and the decocting that adds 7～9 times of amounts boils 2 times, 2 hours for the first time, 1.5 hours for the second time, collecting decoction, filtered, and is condensed into thick paste, add cane sugar powder mixed pelletization, dry, obtain finished product.
The beneficial effect that adopts technique scheme to produce is:
Function of the present invention cures mainly: the dispelling toxins and dredging collaterals that dispels the wind, benefiting QI and nourishing blood righting, the pain of joint muscle causing for rheumatoid arthritis, ankylosing spondylitis and other rheumatism immune diseases, swelling, limitation of activity etc.
Pharmaceutical composition of the present invention is through repeated screening, adopts medicine and the Radix Tripterygii Wilfordii of existing heat-clearing and toxic substances removing, removing heat from blood dredging collateral to share, and has synergistic therapeutic action, again can benefiting QI and nourishing blood, hepatoprotective kidney tonifying, and to alleviate the toxic and side effects of Radix Tripterygii Wilfordii.In side, Caulis Sinomenii is searched wind prevailing over dampness, arthralgia relieving by relaxing muscles and tendons, and Radix Tripterygii Wilfordii dispelling toxins and dredging collaterals, anti-inflammation detumescence are monarch drug altogether; Herba Epimedii expelling wind and removing dampness, Radix Gentianae Macrophyllae wind expelling stagnation removing, Caulis Spatholobi, Radix Salviae Miltiorrhizae, Rhizoma Corydalis activating blood circulation and unblocking obstruction, strengthening principal agent curative effect is ministerial drug altogether; Assistant is with the Radix Astragali, Radix Rehmanniae, Herba Epimedii, Radix Paeoniae Alba qi and blood tonifying, and negative and positive are taken into account with righting, Radix Et Rhizoma Rhei clearing away heat and purging, and Radix Scutellariae heat clearing and damp drying is to get rid of evils, and the bias of principal agent processed of can holding concurrently, Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription.Through clinical this preparation of reference validation, have no adverse reaction, toxicity is less, safe and reliable.
Following test example further illustrates beneficial effect of the present invention.The outturn sample of the present invention that wherein used is the pill product of following embodiment 1 preparation.During human trial, usage and dosage of the present invention is: oral, and one time 0.5 bag (4g), 2 times on the one; It within one month, is a course for the treatment of.
Test example (1), acute toxicity test in mice
The college of traditional Chinese medicine of Hebei Medical University is studied the acute toxicity test in mice of this product, result shows: 20 of Kunming Strains of Mouses, twice on the one gastric infusion of per os, when dosage is 24g/kg/ day (be equivalent to quantity 120 times), Continuous Observation one week, mice, without death, is not found untoward reaction.According to < < study of tcm new drug guide > > (94～0198) chapter 2 the acute toxicity tests evaluation criterion, this product oral administration acute toxicity is for substantially nontoxic.
Test example (2), the mice test of pesticide effectiveness
The college of traditional Chinese medicine of Hebei Medical University herbal pharmacology research department has carried out experimental study to the drug effect of this product, result of study shows: pharmaceutical composition of the present invention (0.7g/kg, 1.4g/kg, 2.8g/kg) can suppress to intersect rat paw edema due to dish glue, suppresses the swollen hypertrophy of rat granuloma; Pharmaceutical composition of the present invention (0.9g/kg, 1.8g/kg, 3.6g/kg) can obviously suppress the swelling of xylol induced mice auricular concha, improves hot plate method in mice pain threshold, and 0.6% acetic acid induced mice pain is had to obvious analgesic activity.
Test example (3), rat chronic toxicity test
Herbal pharmacology teaching and research room of the college of traditional Chinese medicine of Hebei Medical University has carried out rat chronic toxicity test to this product.Result shows: oral suspension administration, dosage is 6g/kg, 3g/kg, 1.5g/kg(is equivalent to 30 times of quantity, 15 times, 7.5 times), tested medicine shows 90 days long term tests of SD rat oral gavage administration, animal general status no abnormality seen, the body weight of each administration group, erythrocyte number, hemoglobin, platelet count, numeration of leukocyte and classification, the hematological indices such as clotting time and aspartate aminotransferase, alanine aminotransferase, alkali phosphatase, blood urea nitrogen, total protein, albumin, blood glucose, total bilirubin, creatinine, the blood parameters such as T-CHOL, with the more equal no significant difference of blank group.The main organs weight coefficient of each administration treated animal and matched group comparison, also no significant difference.Pathological examination no abnormality seen.After drug withdrawal 14 days, the hematological indices of administration treated animal, blood parameters, main organs weight coefficient and the more equal zero difference of matched group, pathological examination is respectively organized also no abnormality seen of internal organs.Illustrate that this product medication under experimental condition is basic security.Prompting this product is used under prescribed dose may be safe and reliable.
Test example (4), clinical observation on the therapeutic effect
Pharmaceutical composition of the present invention is that Shijiazhuang safety hospital is through research for many years, heat-clearing and toxic substances removing, removing heat from blood dredging collateral medicine and Radix Tripterygii Wilfordii are share, the therapeutical effect of not only there is tonify deficiency, blood stasis dispelling, getting rid of evils, and have the synergistic therapeutic action of benefiting QI and nourishing blood, hepatoprotective kidney tonifying, can alleviate the toxic and side effects of Radix Tripterygii Wilfordii.In order to verify clinical efficacy and the safety of medicine composite for curing rheumatoid arthritis of the present invention, Shijiazhuang City, Hebei Province safety hospital, adopt the observational technique of random contrast, carry out clinical contrast observation with positive control drug Tripterygium wilfordii Polyglycosidium Tablets, it is retention of damp-heat in the interior, deficiency of qi and blood, congestion resistance network card person the case of signing Informed Consent Form that tested case is the diagnostic criteria, the Chinese medical discrimination that meet rheumatoid arthritis.Complete altogether clinical observation 120 examples, be my Out-patient Department and inpatient of in January, 2006 ~ 2007 year December, in accordance with district's group randomization, be divided into pharmaceutical composition group of the present invention (being treatment group) and Tripterygium wilfordii Polyglycosidium Tablets group (being matched group), each 60 examples.Result of the test shows, treats after 3 courses for the treatment of, and the slow aobvious rate for the treatment of group is 78.3%, and the slow aobvious rate of matched group is 43.33%, and treatment group is higher than matched group, and relatively there were significant differences (P < 0.05); Two groups of patient's traditional Chinese medical science disease Clinical efficacy comparisons, treatment group total effective rate is 98.33%, and matched group total effective rate is 95.00%, and treatment group is higher than matched group, and relatively there were significant differences (P < 0.05).Visible pharmaceutical composition of the present invention is rheumatoid arthritis patient's clinical symptoms preferably, obviously improves arthralgia, the swelling degree of patient with rheumatoid arthritis.Apply medicine composite for curing Rheumatoid Arthritis of the present invention remarkable.
The specific embodiment
Following examples describe the present invention in detail.Various raw material used in the present invention and items of equipment are conventional commercially available prod, all can be bought directly and be obtained by market.
The instructions of taking of pharmaceutical composition of the present invention is: oral, and once half bag to one bag, every packed 8g, 2 times on the one, sooner or later respectively once; Anemia of pregnant woman, liver function injury, renal insufficiency person forbidding, give up alcohol, strong tea, makes regular check on routine blood test, hepatic and renal function.
In following embodiment, relate to the concepts such as " coarse powder ", " fine powder ", " fine powder ", its concrete meaning is as follows:
1. powder grades:
Coarse powder refers to all by a sieve, but be mixed with, can be no more than 20% powder by No. three sieves;
Coarse powder refers to all by No. two sieves, but be mixed with, can be no more than 40% powder by No. four sieves;
Middle powder refers to all by No. four sieves, but be mixed with, can be no more than 60% powder by No. five sieves;
Fine powder refers to all by No. five, to sieve, and containing being no less than 95% powder by No. six sieves;
Fine powder refers to can be all by No. six sieves, and containing being no less than 95% powder by No. seven sieves;
Impalpable powder refers to all by No. eight, to sieve, and containing being no less than 95% powder by No. nine sieves;
2. medicine screening etc.:
Embodiment 1
Treat a pharmaceutical composition for rheumatoid arthritis, the main pharmacodynamics raw material of making by ratio of weight and the number of copies this pharmaceutical composition is: Caulis Sinomenii 84, Radix Tripterygii Wilfordii 84, Herba Epimedii 84, Radix Gentianae Macrophyllae 84, Caulis Spatholobi 168, Radix Salviae Miltiorrhizae 168, Rhizoma Corydalis 112, the Radix Astragali 168, Radix Rehmanniae 168, the Radix Paeoniae Alba 84, Radix Et Rhizoma Rhei 56, Radix Scutellariae 56, Radix Glycyrrhizae 56.Its preparation process comprises:
A, according to above-mentioned formula, take each pharmacodynamic raw materials, wherein Radix Gentianae Macrophyllae, Radix Salviae Miltiorrhizae, Rhizoma Corydalis, the Radix Astragali, the Radix Paeoniae Alba, Radix Glycyrrhizae, Radix Et Rhizoma Rhei, Radix Scutellariae eight taste medicated powder are broken into fine powder;
B, Caulis Sinomenii, Radix Tripterygii Wilfordii, Radix Rehmanniae, Caulis Spatholobi, Herba Epimedii five kinds of Chinese medicine add 8 times of water gagings and decoct three times, and each 1 hour, collecting decoction, filtered, and filtrate is concentrated into the clear paste that relative density is 1.10g/ml～1.20g/ml (50 ℃～60 ℃);
C, steps A gained fine powder is joined in the clear paste of step B, mix, dry, pulverize into fine powder, sieve;
D, every 100g step C gained powder add water with refined honey 31g～39g and make water-honeyed pill 1000g, dry, obtain finished product.
Embodiment 2
Treat a pharmaceutical composition for rheumatoid arthritis, the main pharmacodynamics raw material of making by ratio of weight and the number of copies this pharmaceutical composition is: Caulis Sinomenii 85, Radix Tripterygii Wilfordii 85, Herba Epimedii 82, Radix Gentianae Macrophyllae 86, Caulis Spatholobi 170, Radix Salviae Miltiorrhizae 162, Rhizoma Corydalis 110, the Radix Astragali 173, Radix Rehmanniae 174, the Radix Paeoniae Alba 82, Radix Et Rhizoma Rhei 54, Radix Scutellariae 58, Radix Glycyrrhizae 54.
Its preparation method is: according to above-mentioned formula, take each pharmacodynamic raw materials, be ground into fine powder, sieve, every 100g gained powder adds water with refined honey 31g～39g and makes water-honeyed pill 1000g, dry, obtains finished product.
Embodiment 3
The drug regimen composition formula of the present embodiment is identical with embodiment 1.
Its preparation method is: according to above-mentioned formula, take each pharmacodynamic raw materials, the decocting that adds 8 times of amounts boils 2 times, 2 hours for the first time, 1.5 hours for the second time, collecting decoction, filtered, be condensed into thick paste, add cane sugar powder (consumption of cane sugar powder is: make every 15g raw medicinal herbs make 10g product particle) mixed pelletization, dry, obtain finished product.
In addition, dry cream, thick paste or mixture of powders prepared by the above embodiment of the present invention can add Mel or other pharmaceutically acceptable excipient, makes pill or other acceptable granule, drop pill, tablet, capsule, suspensoid, oral liquid etc. clinically.
Foregoing description only proposes as the enforceable technical scheme of the present invention, not as the Single restriction condition to its technical scheme itself.
Claims (2)
1. treat a preparation method for the pharmaceutical composition of rheumatoid arthritis, its characterization step comprises:
A, the pharmacodynamic raw materials of making by ratio of weight and the number of copies this pharmaceutical composition are: Caulis Sinomenii 82～86, Radix Tripterygii Wilfordii 82～86, Herba Epimedii 82～86, Radix Gentianae Macrophyllae 82～86, Caulis Spatholobi 160～175, Radix Salviae Miltiorrhizae 160～175, Rhizoma Corydalis 108～116, the Radix Astragali 160～175, Radix Rehmanniae 160～175, the Radix Paeoniae Alba 82～86, Radix Et Rhizoma Rhei 54～58, Radix Scutellariae 54～58, Radix Glycyrrhizae 54～58; According to above-mentioned formula, take each pharmacodynamic raw materials, wherein Radix Gentianae Macrophyllae, Radix Salviae Miltiorrhizae, Rhizoma Corydalis, the Radix Astragali, the Radix Paeoniae Alba, Radix Glycyrrhizae, Radix Et Rhizoma Rhei, Radix Scutellariae eight taste medicated powder are broken into fine powder;
B, Caulis Sinomenii, Radix Tripterygii Wilfordii, Radix Rehmanniae, Caulis Spatholobi, Herba Epimedii five kinds of Chinese medicine add 6～10 times of water gagings and decoct, and decocting liquid filters, and filtrate is concentrated into the clear paste that relative density is 1.10g/ml～1.20g/ml;
C, steps A gained fine powder is joined in the clear paste of step B, mix, dry, pulverize into fine powder, sieve; Every 100g gained powder adds water with refined honey 31g～39g and makes water-honeyed pill 1000g, dry, obtains finished product.
2. the preparation method of the pharmaceutical composition for the treatment of rheumatoid arthritis according to claim 1, it is characterized in that: in step B, Caulis Sinomenii, Radix Tripterygii Wilfordii, Radix Rehmanniae, Caulis Spatholobi, Herba Epimedii five kinds of Chinese medicine add 8 times of water gagings and decoct 2～4 times, decoct altogether 2 hours～4 hours, after collecting decoction, continue subsequent step.
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| CN103028084A (en) * | 2012-12-17 | 2013-04-10 | 中山大学 | Traditional Chinese medicine composition for treating rheumatoid arthritis and preparation method |
| CN105194207B (en) * | 2015-10-22 | 2020-09-25 | 黄清春 | Traditional Chinese medicine composition and application thereof |
| CN105327017A (en) * | 2015-11-27 | 2016-02-17 | 孙滨 | Traditional Chinese medicine for treating rheumatoid arthritis |
| CN108653504A (en) * | 2018-06-27 | 2018-10-16 | 玉林市中西医结合骨科医院 | A kind of drug and preparation method thereof for treating ankylosing spondylitis |
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| CN1293976A (en) * | 2000-11-21 | 2001-05-09 | 王靖平 | Composite Chinese medicine for treating diseases caused by wind and cold |
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