CN102670831A - 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 of with the vegetable Chinese herbal medicine be raw material process be used for the Chinese medicine preparation that clearing away heat and cooling blood, dispelling toxins and dredging collaterals, benefiting QI and nourishing blood are set upright; The invention still further relates to the method for preparing of this pharmaceutical preparation.
Background technology
Dermatomyositis (DM) is a striped muscle apyetous disease, be a kind of be characteristic with carrying out property symmetry muscle weakness proximal and amyotrophy to a certain degree and typical skin injury, and can add up the chronic inflammation autoimmune disease of a plurality of systems and organ.The definite cause of disease of primary disease is still not fully aware of, thinks the autoimmune disease that genetic predisposition and environmental factors combined effect cause at present.Still lack of specific treatment belongs to difficult and complicated illness.Modern medicine treatment choice drug is a glucocorticoid, like prednisone.Secondly be immunosuppressant,, also have other drug such as tripterygium glycosides, antimalarial etc. like methotrexate, azathioprine, cyclophosphamide etc.But the toxicity of these medicines and untoward reaction are restricted its prolonged application.So the how development of disease controlling, the toxicity that how to reduce western medicine becomes the focus and the difficult point of current research.
Summary of the invention
The technical problem that the present invention will solve provides a kind of pharmaceutical composition of treating dermatomyositis and preparation method thereof; Can clearing away heat and cooling blood, dispelling toxins and dredging collaterals, QI invigorating set upright and nourish blood, and is used for the heating, erythema, pain of joint muscle, swelling, movable unfavorable etc. of systemic lupus erythematosus (sle), dermatomyositis and other rheumatism immune diseases.
For solving the problems of the technologies described above, the technical scheme that the present invention taked is following.
A kind of pharmaceutical composition of treating dermatomyositis, the main pharmacodynamics raw material of processing this pharmaceutical composition by ratio of weight and the number of copies 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 kind of optimal technical scheme of the present invention, the main pharmacodynamics raw material of processing this pharmaceutical composition by ratio of weight and the number of copies 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 kind of optimal technical scheme of the present invention, the main pharmacodynamics raw material of processing this pharmaceutical composition by ratio of weight and the number of copies 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 kind of optimal technical scheme of the present invention, the main pharmacodynamics raw material of processing this pharmaceutical composition by ratio of weight and the number of copies 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 of drug combination method of above-mentioned treatment dermatomyositis: take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, through pulverize, the water concentration contracts or the two bonded mode with each pharmacodynamic raw materials mixing, promptly get.
As a kind of optimal technical scheme of above-mentioned method for preparing, its step comprises:
A, take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, 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 filtrating 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, mixing, 70 ℃～90 ℃ dryings are ground into fine powder, cross 80 mesh sieves, promptly get.
As a kind of optimal technical scheme of above-mentioned method for preparing, every 100g step C products obtained therefrom adds drinking water with 75g～85g mulse and processes water-honeyed pill 1000g, and drying gets finished product.
As a kind of optimal technical scheme of above-mentioned method for preparing, among the 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 collecting decoction continued subsequent step altogether 2 hours～4 hours.
A kind of optimal technical scheme as above-mentioned method for preparing takes by weighing each pharmacodynamic raw materials according to above-mentioned prescription, is ground into fine powder, sieves, and every 100g gained powder adds water with refined honey 27g～33g and processes water-honeyed pill 1000g, and drying gets finished product.
As a kind of optimal technical scheme of above-mentioned method for preparing, the method for preparing of present embodiment product is: take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, 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; Filter, be condensed into thick paste, add the cane sugar powder mixed pelletization; Drying gets finished product.
Adopt the beneficial effect that technique scheme produced to be:
Function of the present invention cures mainly: can clearing away heat and cooling blood, dispelling toxins and dredging collaterals, benefiting QI and nourishing blood set upright, be used for the heating, erythema, pain of joint muscle, swelling, movable unfavorable etc. of systemic lupus erythematosus (sle), dermatomyositis and other rheumatism immune diseases.Pharmaceutical composition of the present invention is rheumatism immunity section of a Shijiazhuang safety hospital experience prescription; Clinical efficacy is remarkable; And toxicity obviously reduces than 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, and great toxicity did not take place determined curative effect.
Pharmaceutical composition of the present invention is through repeated screening, adopts the medicine and the Radix Tripterygii Wilfordii of existing heat-clearing and toxic substances removing, removing heat from blood collateral dredging to share, and has synergistic therapeutic action, again can benefiting QI and nourishing blood, the 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 the side, Radix Tripterygii Wilfordii dispelling toxins and dredging collaterals, anti-inflammation detumescence are 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 collateral dredging are strengthened the principal agent curative effect and are 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.Have no adverse reaction through this preparation of clinical practice checking, toxicity is less, and is safe and reliable.
Following Test Example further illustrates beneficial effect of the present invention.Wherein employed outturn sample of the present invention is the pill product of following embodiment 1 preparation.Usage and dosage of the present invention is during human trial: 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 these article; The result shows: 20 of Kunming strain mices; When twice on the one gastric infusion of per os, dosage are 24g/kg/ day (be equivalent to clinical consumption 120 times), observe a week continuously; Mice does not have death, does not find any untoward reaction.According to " study of tcm new drug guide " (94～0198) chapter 2 The acute toxicity tests evaluation criterion, these article oral administration acute toxicity is nontoxic for basically.
Test Example (2), the mice test of pesticide effectiveness
Herbal pharmacology teaching and research room of the college of traditional Chinese medicine of Hebei Medical University is to the drug effect research experiment of these article; The result shows; Pharmaceutical composition of the present invention (0.7g/kg, 1.4g/kg, 2.8g/kg) can suppress rat group swelling due to the 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 the mice delayed hypersensitivity; The swelling of xylol induced mice auricular concha has obvious inhibitory action; Improve mice hot plate method pain threshold; 0.6% acetic acid induced mice pain there is obvious analgesic activity.
Test Example (3), rat long term toxicity test.
The college of traditional Chinese medicine of Hebei Medical University herbal pharmacology laboratory has carried out the rat long term toxicity test to these article.Result: per os gastric infusion; Dosage is 1.5g/kg, 3g/kg, 6g/kg (be equivalent to clinical application 7.5 times, 15 times, 30 times); The result shows, pharmaceutical composition of the present invention (1.5g/kg, 3g/kg, 6g/kg) does not all have obvious influence to the general situation of rat, body weight, hematological indices, ten biochemical indicators and main organs coefficient; Each internal organs naked eyes and mirror are observed down, also do not have obvious pathological change.These article of explanation basic security during medication under experiment condition.These article of prompting use under prescribed dose maybe be safe and reliable.
Test Example (4), clinical observation on the therapeutic effect.
For clinical efficacy property and the safety of verifying medicine composite for curing dermatomyositis of the present invention; Shijiazhuang City, Hebei Province safety hospital; Adopt the observational technique of contrast at random; Carry out the clinical contrast observation with positive control drug tripterygium glycosides sheet, tried case be meet the dermatomyositis diagnostic criteria, Chinese medical discrimination is the pyretic toxicity stasis of blood resistance person of BI-syndrome involved the muscle, and the signature Informed Consent Form case.Clinical observation 120 examples are accomplished in test altogether, test group 60 examples wherein, matched group 60 examples.This group result of study shows, treats 1 post-evaluation course of treatment curative effect (three months is a course of treatment), 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).Behind two groups of patient treatments before the treatment traditional Chinese medical science disease have clear improvement, and the treatment group is higher than matched group, relatively there were significant differences (P＜0.05).It is thus clear that pharmaceutical composition of the present invention can effectively improve dermatomyositis patient clinical symptoms and sign, improve 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 using medicine composite for curing dermatomyositis of the present invention is remarkable.
The specific embodiment
Following examples have specified the present invention.Various raw material used in the present invention and items of equipment are conventional commercially available prod, all can buy directly through market to obtain.
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.
Relate to notions such as " coarse powder ", " fine powder ", " fine powder " among the following embodiment, its concrete implication is following:
1. powder grades:
2. medicine screening etc.:
Embodiment 1
A kind of pharmaceutical composition of treating dermatomyositis, the main pharmacodynamics raw material of processing this pharmaceutical composition by ratio of weight and the number of copies 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, take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, 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 filtrating 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, mixing, 80 ℃ of dryings are ground into fine powder, cross 80 mesh sieves;
D, every 100g step C products obtained therefrom add drinking water with 75g～85g mulse and process water-honeyed pill 1000g, and drying gets finished product; Wherein mulse is made into for adding boiling water with the refining evil spirit, and containing the honey amount is 75%.
Embodiment 2
A kind of pharmaceutical composition of treating dermatomyositis, the main pharmacodynamics raw material of processing this pharmaceutical composition by ratio of weight and the number of copies 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: take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, be ground into fine powder, sieve, every 100g gained powder adds water with refined honey 27g～33g and processes water-honeyed pill 1000g, and drying gets finished product.
Embodiment 3
The drug regimen composition formula of present embodiment is identical with embodiment 1.
Its preparation method is: take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, 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 the 10g product particle) mixed pelletization, drying gets finished product.
In addition; Dried cream, thick paste or the mixture of powders of the above embodiment of the present invention preparation can add Mel or other pharmaceutically acceptable excipient, process pill or other acceptable clinically granules, drop pill, tablet, capsule, suspensoid, oral liquid etc.
Foregoing description only proposes as the enforceable technical scheme of the present invention, not as the single restrictive condition to its technical scheme itself.
Claims (10)
1. a pharmaceutical composition of treating dermatomyositis is characterized in that the main pharmacodynamics raw material of processing this pharmaceutical composition by ratio of weight and the number of copies 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.
2. the pharmaceutical composition of treatment dermatomyositis according to claim 1 is characterized in that: the main pharmacodynamics raw material of processing this pharmaceutical composition by ratio of weight and the number of copies 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.
3. the pharmaceutical composition of treatment dermatomyositis according to claim 2 is characterized in that: the main pharmacodynamics raw material of processing this pharmaceutical composition by ratio of weight and the number of copies 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.
4. the pharmaceutical composition of treatment dermatomyositis according to claim 2 is characterized in that: the main pharmacodynamics raw material of processing this pharmaceutical composition by ratio of weight and the number of copies 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.
5. the preparation of drug combination method of above-mentioned treatment dermatomyositis is characterized in that: take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, through pulverize, the water concentration contracts or the two bonded mode with each pharmacodynamic raw materials mixing, promptly get.
6. method for preparing according to claim 5, its characterization step comprises:
A, take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, 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 filtrating 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, mixing, 70 ℃～90 ℃ dryings are ground into fine powder, cross 80 mesh sieves, promptly get.
7. method for preparing according to claim 6 is characterized in that: every 100g step C products obtained therefrom adds drinking water with 75g～85g mulse and processes water-honeyed pill 1000g, and drying gets finished product.
8. method for preparing according to claim 6 is characterized in that: among the 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 collecting decoction continued subsequent step altogether 2 hours～4 hours.
9. method for preparing according to claim 5 is characterized in that: take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, be ground into fine powder, sieve, every 100g gained powder adds water with refined honey 27g～33g and processes water-honeyed pill 1000g, and drying gets finished product.
10. method for preparing according to claim 5 is characterized in that: the method for preparing of present embodiment product is: take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, 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; Filter, be condensed into thick paste, add the cane sugar powder mixed pelletization; Drying gets finished product.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105434894A (en) * | 2014-01-02 | 2016-03-30 | 青岛华之草医药科技有限公司 | Method for preparing traditional Chinese medicine composition for treating systemic lupus erythematosus |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105434894A (en) * | 2014-01-02 | 2016-03-30 | 青岛华之草医药科技有限公司 | Method for preparing traditional Chinese medicine composition for treating systemic lupus erythematosus |
| CN105521302A (en) * | 2014-01-02 | 2016-04-27 | 青岛华之草医药科技有限公司 | Applications of traditional Chinese medicinal composition in preparing medicines for treating systemic lupus erythematosus |
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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. |