CN102670831B - Medicinal composition for treating dermatomyositis and preparation method thereof - Google Patents
Medicinal composition for treating dermatomyositis and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a medicinal composition for treating dermatomyositis. The medicinal composition is prepared from the following main raw materials in part by weight: 100 to 200 parts of buffalo horn, 10 to 100 parts of tripterygium wilfordii, 100 to 200 parts of rehmannia root, 10 to 100 parts of rhubarb, 100 to 200 parts of sweet wormwood herb, 100 to 200 parts of red-rooted salvia root, 100 to 200 parts of suberect spatholobus stem, 100 to 200 parts of astragalus, 10 to 100 parts of epimedium herb and 10 to 100 parts of liquoric root. A preparation method for the medicinal composition comprises the following steps of: weighing the raw materials according to a formula, and uniformly mixing the raw materials by crush and water extraction and concentration or in a mode of combining the crush and the water extraction and concentration to obtain the medicinal composition. The medicinal composition can clear heat and cool blood, remove toxicity and dredge collaterals, tonify qi, strengthen the body resistance and nourish blood, and is used for fever, erythema, pain of joints and muscle, swell, laborious activity and the like caused by systemic lupus erythematosus, dermatomyositis and other rheumatism immunological diseases.
Description
Technical field
The present invention relates to technical field of pharmaceuticals, especially a kind ofly take the Chinese medicine preparation for clearing away heat and cooling blood, dispelling toxins and dredging collaterals, benefiting QI and nourishing blood righting that vegetable Chinese herbal medicine makes as raw material; The invention still further relates to the preparation method of this pharmaceutical preparation.
Background technology
Dermatomyositis (DM) is striped muscle apyetous disease, is that a kind of to take carrying out property symmetry muscle weakness proximal and amyotrophy to a certain degree and typical skin injury be feature, and can adds up the chronic inflammation autoimmune disease of a plurality of organs and systems.The definite cause of disease of primary disease is still not fully aware of, thinks at present the autoimmune disease that genetic predisposition and environmental factors combined effect cause.Still lack specific treatment, belong to difficult and complicated illness.Modern medicine treatment choice drug is glucocorticoid, as prednisone.Secondly be immunosuppressant, as methotrexate, azathioprine, cyclophosphamide etc., also have other drug as tripterygium glycosides, antimalarial etc.But the toxicity of these medicines and untoward reaction are restricted its prolonged application.Therefore how to control the development of the state of an illness, the toxicity that how to reduce western medicine becomes focus and the difficult point of current research.
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 dermatomyositis and preparation method thereof, can clearing away heat and cooling blood, dispelling toxins and dredging collaterals, QI invigorating righting nourish blood, for the heating of systemic lupus erythematosus (sle), dermatomyositis and other rheumatism immune diseases, erythema, pain of joint muscle, swelling, movable unfavorable etc.
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 dermatomyositis, the main pharmacodynamics raw material of making by ratio of weight and the number of copies this pharmaceutical composition is: Cornu Bubali 100～200; Radix Tripterygii Wilfordii 10～100; Radix Rehmanniae 100～200; Radix Et Rhizoma Rhei 10～100; Herba Artemisiae Annuae 100～200; Radix Salviae Miltiorrhizae 100～200; Caulis Spatholobi 100～200; The Radix Astragali 100～200; Herba Epimedii 10～100; Radix Glycyrrhizae 10～100.
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: Cornu Bubali 115～125; Radix Tripterygii Wilfordii 55～65; Radix Rehmanniae 115～125; Radix Et Rhizoma Rhei 38～42; Herba Artemisiae Annuae 115～125; Radix Salviae Miltiorrhizae 115～125; Caulis Spatholobi 115～125; The Radix Astragali 115～125; Herba Epimedii 45～50; Radix Glycyrrhizae 38～42.
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: Cornu Bubali 120; Radix Tripterygii Wilfordii 60; Radix Rehmanniae 120; Radix Et Rhizoma Rhei 40; Herba Artemisiae Annuae 120; Radix Salviae Miltiorrhizae 120; Caulis Spatholobi 120; The Radix Astragali 120; Herba Epimedii 48; Radix Glycyrrhizae 40.
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: Cornu Bubali 114; Radix Tripterygii Wilfordii 55; Radix Rehmanniae 125; Radix Et Rhizoma Rhei 42; Herba Artemisiae Annuae 124; Radix Salviae Miltiorrhizae 121; Caulis Spatholobi 116; The Radix Astragali 115; Herba Epimedii 45; Radix Glycyrrhizae 41.
The preparation method of the pharmaceutical composition of above-mentioned treatment dermatomyositis: 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 Cornu Bubali, Radix Et Rhizoma Rhei, Herba Artemisiae Annuae, Radix Salviae Miltiorrhizae, the Radix Astragali, glycyrrhizic liuwei drug are ground into fine powder;
B, Radix Tripterygii Wilfordii, Radix Rehmanniae, Caulis Spatholobi, Herba Epimedii four 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, 70 ℃～90 ℃ dry, pulverize into fine powder, cross 80 mesh sieves, obtain.
As a kind of optimal technical scheme of above-mentioned preparation method, every 100g step C for products obtained therefrom 75g～85g mulse add drinking water and make water-honeyed pill 1000g, dry, obtain finished product.
As a kind of optimal technical scheme of above-mentioned preparation method, in step B, Radix Tripterygii Wilfordii, Radix Rehmanniae, Caulis Spatholobi, Herba Epimedii four 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 27g～33g and makes water-honeyed pill 1000g, dry, obtains finished product.
A kind of optimal technical scheme as above-mentioned preparation method, the preparation method of the present embodiment product is: according to above-mentioned formula, take each pharmacodynamic raw materials, the decocting that adds 7～9 times of amounts boils 2 times, and 2 hours for the first time, 1.5 hours for the second time, collecting decoction, filter, be 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: can clearing away heat and cooling blood, dispelling toxins and dredging collaterals, benefiting QI and nourishing blood righting, and for the heating of systemic lupus erythematosus (sle), dermatomyositis and other rheumatism immune diseases, erythema, pain of joint muscle, swelling, movable unfavorable etc.Pharmaceutical composition of the present invention is rheumatism immunity section of Shijiazhuang safety hospital experience prescription, clinical efficacy is remarkable, and toxicity obviously reduces compared with single medicinal material, little compound recipe, clinic trial has been treated from various parts of the country being in hospital and the thousands of examples of out-patient,, there is not great toxicity in determined curative effect.
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, alleviate the toxic and side effects of Radix Tripterygii Wilfordii.Cornu Bubali heat-clearing and toxic substances removing, cooling blood and removing stasis in side, Radix Tripterygii Wilfordii dispelling toxins and dredging collaterals, anti-inflammation detumescence, be monarch drug altogether.Radix Rehmanniae, Radix Et Rhizoma Rhei, Herba Artemisiae Annuae clearing away heat,cooling blood and removing toxin, Radix Salviae Miltiorrhizae, Caulis Spatholobi nourishing blood and promoting blood circulation dredging collateral, strengthen principal agent curative effect and be ministerial drug altogether.Assistant is taken into account with the Radix Astragali, Herba Epimedii benefiting qi and supporting yang, spleen kidney, the bias of restriction principal agent ministerial drug, Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription.Through clinical practice, verify that this preparation has 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 8g/ time, 2 times/day.
Test example (1), acute toxicity test in mice
The college of traditional Chinese medicine of Hebei Medical University herbal pharmacology laboratory 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 any 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 drug effect research experiment of herbal pharmacology teaching and research room of the college of traditional Chinese medicine of Hebei Medical University to this product, result shows, pharmaceutical composition of the present invention (0.7g/kg, 1.4g/kg, 2.8g/kg) can suppress rat group swelling due to carrageenin, suppresses the swollen hypertrophy of rat granuloma; Pharmaceutical composition of the present invention (0.9g/kg, 1.8/kg, 3.6g/kg) can obviously suppress 2,4-dinitrofluorobenzene brings out mice delayed hypersensitivity; The swelling of xylol induced mice auricular concha has obvious inhibitory action; Improve hot plate method in mice pain threshold; 0.6% acetic acid induced mice pain is had to obvious analgesic activity.
Test example (3), rat chronic toxicity test.
The college of traditional Chinese medicine of Hebei Medical University herbal pharmacology laboratory has carried out rat chronic toxicity test to this product.Result: per os gastric infusion, dosage is 7.5 times, 15 times, 30 times that 1.5g/kg, 3g/kg, 6g/kg(are equivalent to clinical application), result shows, pharmaceutical composition of the present invention (1.5g/kg, 3g/kg, 6g/kg) all has no significant effect the general status of rat, body weight, hematological indices, ten biochemical indicators and Main Organ Coefficients; Each internal organs naked eyes and Microscopic observation, also without obviously pathological change.This product basic security during medication under experiment condition is described.Prompting this product is used under prescribed dose may be safe and reliable.
Test example (4), clinical observation on the therapeutic effect.
In order to verify clinical efficacy and the safety of medicine composite for curing dermatomyositis 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, tested case is and meets the pyretic toxicity stasis blocking person that dermatomyositis diagnostic criteria, Chinese medical discrimination are BI-syndrome involved the muscle, and the case of signing Informed Consent Form.Test completes clinical observation 120 examples altogether, test group 60 examples wherein, matched group 60 examples.This group result of study shows, treats 1 post-evaluation course for the treatment of curative effect (three months being a course for the treatment of), treatment group total effective rate 100%, matched group total effective rate 98.3%.Cure-remarkable-effectiveness rate treatment group is apparently higher than matched group, and relatively there were significant differences (P < 0.05).After two groups of patient treatments, traditional Chinese medical science disease has clear improvement before treatment, and treatment group is higher than matched group, and relatively there were significant differences (P < 0.05).Visible, pharmaceutical composition of the present invention can effectively improve patient with dermatomyositis clinical symptoms and sign, improves patient's quality of life, the effect of effectively playing efficacy enhancing and toxicity reducing, stablizing the state of an illness.The short term effect of applying medicine composite for curing dermatomyositis of the present invention is 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, follow the doctor's advice and make 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:
2. medicine screening etc.:
Embodiment 1
Treat a pharmaceutical composition for dermatomyositis, the main pharmacodynamics raw material of making by ratio of weight and the number of copies this pharmaceutical composition is: Cornu Bubali 120; Radix Tripterygii Wilfordii 60; Radix Rehmanniae 120; Radix Et Rhizoma Rhei 40; Herba Artemisiae Annuae 120; Radix Salviae Miltiorrhizae 120; Caulis Spatholobi 120; The Radix Astragali 120; Herba Epimedii 48; Radix Glycyrrhizae 40.Its preparation process comprises:
A, according to above-mentioned formula, take each pharmacodynamic raw materials, wherein Cornu Bubali, Radix Et Rhizoma Rhei, Herba Artemisiae Annuae, Radix Salviae Miltiorrhizae, the Radix Astragali, glycyrrhizic liuwei drug are ground into fine powder;
B, Radix Tripterygii Wilfordii, Radix Rehmanniae, Caulis Spatholobi, Herba Epimedii four Chinese medicine add 8 times of water gagings and decoct three times, and each 1 hour, collecting decoction, filtered, and it is 1.10g/ml～1.20g/ml(50～60 ℃ that filtrate is concentrated into relative density) clear paste;
C, steps A gained fine powder is joined in the clear paste of step B, mix, 80 ℃ dry, pulverize into fine powder, cross 80 mesh sieves;
D, every 100g step C for products obtained therefrom 75g～85g mulse add drinking water and make water-honeyed pill 1000g, dry, obtain finished product; Wherein mulse is made into for adding boiling water by refining evil spirit, containing honey amount, is 75%.
Embodiment 2
Treat a pharmaceutical composition for dermatomyositis, the main pharmacodynamics raw material of making by ratio of weight and the number of copies this pharmaceutical composition is: Cornu Bubali 114; Radix Tripterygii Wilfordii 55; Radix Rehmanniae 125; Radix Et Rhizoma Rhei 42; Herba Artemisiae Annuae 124; Radix Salviae Miltiorrhizae 121; Caulis Spatholobi 116; The Radix Astragali 115; Herba Epimedii 45; Radix Glycyrrhizae 41.
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 27g～33g 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 (5)
1. a pharmaceutical composition for the treatment of dermatomyositis, is characterized in that: the pharmacodynamic raw materials of making by ratio of weight and the number of copies this pharmaceutical composition is: Cornu Bubali 115～125; Radix Tripterygii Wilfordii 55～65; Radix Rehmanniae 115～125; Radix Et Rhizoma Rhei 38～42; Herba Artemisiae Annuae 115～125; Radix Salviae Miltiorrhizae 115～125; Caulis Spatholobi 115～125; The Radix Astragali 115～125; Herba Epimedii 45～50; Radix Glycyrrhizae 38～42.
2. the pharmaceutical composition for the treatment of dermatomyositis according to claim 1, is characterized in that: the pharmacodynamic raw materials of making by ratio of weight and the number of copies this pharmaceutical composition is: Cornu Bubali 120; Radix Tripterygii Wilfordii 60; Radix Rehmanniae 120; Radix Et Rhizoma Rhei 40; Herba Artemisiae Annuae 120; Radix Salviae Miltiorrhizae 120; Caulis Spatholobi 120; The Radix Astragali 120; Herba Epimedii 48; Radix Glycyrrhizae 40.
3. the preparation method of the pharmaceutical composition of the treatment dermatomyositis described in claim 1-2 any one, its characterization step comprises:
A, according to above-mentioned formula, take each pharmacodynamic raw materials, wherein Cornu Bubali, Radix Et Rhizoma Rhei, Herba Artemisiae Annuae, Radix Salviae Miltiorrhizae, the Radix Astragali, glycyrrhizic liuwei drug are ground into fine powder;
B, Radix Tripterygii Wilfordii, Radix Rehmanniae, Caulis Spatholobi, Herba Epimedii four 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, 70 ℃～90 ℃ dry, pulverize into fine powder, cross 80 mesh sieves, obtain.
4. preparation method according to claim 3, is characterized in that: every 100g step C for products obtained therefrom 75g～85g mulse add drinking water and make water-honeyed pill 1000g, dry, obtain water-honeyed pill dosage form product.
5. preparation method according to claim 3, is characterized in that: in step B, Radix Tripterygii Wilfordii, Radix Rehmanniae, Caulis Spatholobi, Herba Epimedii four 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.
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| CN1709400A (en) * | 2005-06-07 | 2005-12-21 | 董根荣 | Medicine for treating ulcer haemorrhage |
| CN101850080A (en) * | 2010-06-03 | 2010-10-06 | 浙江中医药大学 | Chinese medicinal composition for relieving hormone side effect |
| CN102335274A (en) * | 2010-07-28 | 2012-02-01 | 复旦大学附属华山医院 | Chinese medicinal composition for preventing and treating inflammation-related diseases |
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| JPH06321795A (en) * | 1993-05-07 | 1994-11-22 | Kuga Takaaki | Medicine for treating dermatosis such as atopic dermatosis |
| KR100981038B1 (en) * | 2008-06-09 | 2010-09-10 | 최양원 | Composition for treating atopy and acne |
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| CN1709400A (en) * | 2005-06-07 | 2005-12-21 | 董根荣 | Medicine for treating ulcer haemorrhage |
| CN101850080A (en) * | 2010-06-03 | 2010-10-06 | 浙江中医药大学 | Chinese medicinal composition for relieving hormone side effect |
| CN102335274A (en) * | 2010-07-28 | 2012-02-01 | 复旦大学附属华山医院 | Chinese medicinal composition for preventing and treating inflammation-related diseases |
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Inventor after: Li Xuezeng Inventor after: Wang Xiaojun Inventor after: Han Jufang Inventor after: Li Xiaoyun Inventor after: Ge Haiqing Inventor after: Zhang Hongpan Inventor after: Niu Hanchun Inventor after: Tian Hengchuang Inventor after: Ren Wenxiao Inventor before: Huang Huaipeng Inventor before: Wang Xiaojun Inventor before: Han Jufang Inventor before: Tao Jun Inventor before: Li Jinghan |
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Free format text: CORRECT: INVENTOR; FROM: HUANG HUAIPENG WANG XIAOJUN HAN JUFANG TAO JUN LI JINGHAN TO: LI XUEZENG WANG XIAOJUN HAN JUFANG LI XIAOYUN GE HAIQING ZHANG HONGSHAN NIU HANCHUN TIAN HENGCHUANG REN WENXIAO |
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Effective date of registration: 20170116 Address after: 054001 Xingtai City, Hebei province Xiangdou Qiaodong District Road No. 776 Patentee after: Hebei Gogin Pharmaceutical Co., Ltd. Address before: 050000 Shijiazhuang Feng Road, Hebei, No. 34 Patentee before: Shijiazhuang Pingan Hospital Co.,Ltd. |