Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition gout, determined curative effect for the treatment of.This medicine composite for curing gout is with strong points, and curative effect is better, and side effect is little, and safety is good.
To achieve these goals, technical scheme provided by the invention is:
Treat a pharmaceutical composition for gout, it is to be the medicament that medicinal raw material is made by the Radix Astragali, Herba Epimedii, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) and Rhizoma Dioscoreae.
The weight proportion of pharmaceutical composition of the present invention medicine material used can be: Radix Astragali 9-21 part, Herba Epimedii 8-18 part, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 3-15 part, Rhizoma Dioscoreae 3-15 part.
More preferably the proportioning of pharmaceutical composition of the present invention medicine material used is: Radix Astragali 12-18 part, Herba Epimedii 9-15 part, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 6-12 part, Rhizoma Dioscoreae 6-12 part.
The best proportioning of pharmaceutical composition of the present invention medicine material used is: 15 parts of the Radixs Astragali, 12 parts of Herba Epimedii, 10 parts of Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens)s, 8 parts of Rhizoma Dioscoreaes.
The pharmaceutical composition of above-mentioned treatment gout can be made each crude drug after treatment according to conventional formulation method the medicine of any one dosage form suitable on pharmaceutics, preferably granulation agent, tablet, hard capsule, oral liquid, soft capsule, drop pill etc.
According to the needs of the various drug forms of preparation, pharmaceutical composition of the present invention can adopt and can adopt but be not limited to following methods:
(1) get Milkvetch Root by formula proportion, add 60% alcohol reflux three times of 10 times of volumes, extraction time is respectively 2.0,1.5,1.5h, collects merge extractive liquid, concentrated, in the extracting solution after concentrated, thin up, staticly settle, filter, get supernatant concentration and become rare extractum, dry, obtain Radix Astragali extract.
(2) get epimedium herb, add 95% ethanol extraction 3 times of 6 times of volumes, each 1h, collects merge extractive liquid, suitably concentrated, divides 3 extractions by ethyl acetate, merges the ethyl acetate layer of extraction, is dried after reclaiming solvent, obtains Herba Epimedii extract.
(3) get Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) medical material by formula proportion, add 85% alcohol reflux 3h of 10 times of volumes, collect extracting solution, the centrifugal precipitation of removing, vacuum drying supernatant obtains Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) extract.
(4) get Rhizoma Dioscoreae defibrination, add the water of 10 times of volumes, with 30%NaOH solution adjusting pH to 7-9,2h is extracted in constant temperature (60-80 ℃) water-bath, centrifugal (3000r/min, 15min) collects supernatant, in precipitation, again adds the water of 8 times of volumes to extract, centrifugal collection supernatant, mix rear concentrating under reduced pressure (60 ℃), add 4 ℃ of standing 12h of 70% ethanol of 1 times of volume, centrifugal (3000r/min, 30min) collecting precipitation, 40 ℃ of vacuum dryings obtain Rhizoma Dioscoreae extract.
(5) above-mentioned each extract is mixed, make acceptable various pharmaceutical dosage form.
According to the needs of the various drug forms of preparation, medicine of the present invention also can add suitable pharmaceutic adjuvant as filler, disintegrating agent, binding agent, lubricant, antiseptic etc. in preparation process.
The present invention's various raw medicinal materials used are the Chinese crude drug that meets country or provincial standard regulation.
Compared with prior art, the invention has the beneficial effects as follows:
The present invention treats in the pharmaceutical composition of gout, and Radix Astragali nature and flavor are sweet, warm, returns lung meridian, spleen channel, has invigorating QI to consolidate the body surface resistance, inducing diuresis to remove edema, expelling pus and toxin by strengthening QI, the function of expelling pus and promoting granulation; Herba Epimedii acrid in the mouth, sweet, warm in nature, return liver, kidney channel, there is the function of kidney invigorating and YANG supporting, expelling wind and removing dampness, strong muscle key bone, modern pharmacological research shows that Herba Epimedii has resisting pathogenic microbes effect antiinflammatory action; Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) acrid in the mouth, warm in nature, poisonous, there is drying dampness to eliminate phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, the function of dissolving lump and resolving mass; Rhizoma Dioscoreae sweet in the mouth, property is flat has spleen reinforcing, support lung, reinforce the kidney, the function of benefit essence.Above 4 taste Chinese medicine composition application, have Synergistic function, are used for the treatment of gout, and determined curative effect, shows through clinical research, and it is better that medicine of the present invention is used for the treatment of gout curative effect, and do not find obvious side effect and untoward reaction.
The specific embodiment
Below in conjunction with the specific embodiment, the present invention is described in further detail.
Embodiment 1
The pharmaceutical composition of the treatment gout that the present embodiment is enumerated, is made up of the medicinal raw material of following weight:
Radix Astragali 15g, Herba Epimedii 12g, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 10g, Rhizoma Dioscoreae 8g.
Granulation agent as follows: get the crude drug of described proportioning, add respectively suitable quantity of water, adopt decocting method to extract respectively 2 times, filter, merge 2 times filtrate, by each concentrated solution mix homogeneously, dry after concentrating, after granulation, be distributed into bag and get final product.
Embodiment 2
The pharmaceutical composition of the treatment gout that the present embodiment is enumerated, is made up of the medicinal raw material of following weight:
Radix Astragali 15g, Herba Epimedii 12g, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 10g, Rhizoma Dioscoreae 8g.
Granulation agent as follows: get the crude drug of described proportioning, add respectively appropriate 70% ethanol, adopt reflux extraction to extract respectively 3 times, filter, merges 3 times filtrate, reclaim ethanol and concentrate after by each concentrated solution mix homogeneously, dry, after granulation, be distributed into bag and get final product.
Embodiment 3
The pharmaceutical composition of the treatment gout that the present embodiment is enumerated, is made up of the medicinal raw material of following weight:
Radix Astragali 15g, Herba Epimedii 12g, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 10g, Rhizoma Dioscoreae 8g.
Granulation agent by the following method:
(1) get Milkvetch Root by formula proportion, add 60% alcohol reflux three times of 10 times of volumes, extraction time is respectively 2.0,1.5,1.5h, collects merge extractive liquid, concentrated, in the extracting solution after concentrated, thin up, staticly settle, filter, get supernatant concentration and become rare extractum, dry, obtain Radix Astragali extract.
(2) get epimedium herb, add 95% ethanol extraction 3 times of 6 times of volumes, each 1h, collects merge extractive liquid, suitably concentrated, divides 3 extractions by ethyl acetate, merges the ethyl acetate layer of extraction, is dried after reclaiming solvent, obtains Herba Epimedii extract.
(3) get Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) medical material by formula proportion, add 85% alcohol reflux 3h of 10 times of volumes, collect extracting solution, the centrifugal precipitation of removing, vacuum drying supernatant obtains Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) extract.
(4) get Rhizoma Dioscoreae defibrination, add the water of 10 times of volumes, with 30%NaOH solution adjusting pH to 9,2h, centrifugal collection supernatant are extracted in 70 ℃ of water-baths of constant temperature, in precipitation, again add the water of 8 times of volumes to extract, centrifugal collection supernatant, mixes rear 60 ℃ of concentrating under reduced pressure, adds 4 ℃ of standing 12h of 70% ethanol of 1 times of volume, centrifugal collecting precipitation, 40 ℃ of vacuum dryings obtain Rhizoma Dioscoreae extract.
(5) get above-mentioned each extract mix homogeneously, dry, after granulation, be distributed into bag, granulation agent.
Embodiment 4
The pharmaceutical composition of the treatment gout that the present embodiment is enumerated, is made up of the medicinal raw material of following weight:
Radix Astragali 9g, Herba Epimedii 8g, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 3g, Rhizoma Dioscoreae 3g.
Be prepared into by the following method soft capsule:
(1) get Milkvetch Root by formula proportion, add 95% alcohol reflux three times of 8 times of volumes, extraction time is respectively 2.0,1.5,1.5h, collects merge extractive liquid, concentrated, in the extracting solution after concentrated, thin up, staticly settle, filter, get supernatant concentration and become rare extractum, dry, obtain Radix Astragali extract.
(2) get epimedium herb, add 95% ethanol extraction 3 times of 6 times of volumes, each 1h, collects merge extractive liquid, suitably concentrated, divides 3 extractions by ethyl acetate, merges the ethyl acetate layer of extraction, is dried after reclaiming solvent, obtains Herba Epimedii extract.
(3) get Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) medical material by formula proportion, add 85% alcohol reflux 3h of 8 times of volumes, collect extracting solution, the centrifugal precipitation of removing, vacuum drying supernatant obtains Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) extract.
(4) get Rhizoma Dioscoreae defibrination, add the water of 10 times of volumes, with 30%NaOH solution adjusting pH to 9,2h, centrifugal collection supernatant are extracted in constant temperature (60-80 ℃) water-bath, in precipitation, again add the water of 8 times of volumes to extract, centrifugal collection supernatant, mixes rear concentrating under reduced pressure (60 ℃), adds 4 ℃ of standing 12h of 70% ethanol of 0.3 times of volume, centrifugal collecting precipitation, 40 ℃ of vacuum dryings obtain Rhizoma Dioscoreae extract.
(5) above-mentioned each extract is mixed, add vegetable oil 25g, mix, make capsule casing material with gelatin, be pressed into soft capsule.
Embodiment 5
The pharmaceutical composition of the treatment gout that the present embodiment is enumerated, is made up of the medicinal raw material of following weight:
Radix Astragali 21g, Herba Epimedii 18g, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 15g, Rhizoma Dioscoreae 15g.
(1) get Milkvetch Root by formula proportion, add the ethanol of 8 times of volumes or water reflux, extract, three times, extraction time is respectively 2.0,1.5,1.5h, collects merge extractive liquid, concentrated, in the extracting solution after concentrated, thin up, staticly settle, filter, get supernatant concentration and become rare extractum, dry, obtain Radix Astragali extract.
(2) get epimedium herb, add 60% ethanol extraction 3 times of 6 times of volumes, each 2h, collects merge extractive liquid, suitably concentrated, divides 3 extractions by ethyl acetate, merges the ethyl acetate layer of extraction, is dried after reclaiming solvent, obtains Herba Epimedii extract.
(3) get Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) medical material by formula proportion, add 85% alcohol reflux 3h of 10 times of volumes, collect extracting solution, the centrifugal precipitation of removing, vacuum drying supernatant obtains Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) extract.
(4) get Rhizoma Dioscoreae defibrination, add the water of 8 times of volumes, with 30%NaOH solution adjusting pH to 7,2h, centrifugal collection supernatant are extracted in 60 ℃ of water-baths of constant temperature, in precipitation, again add the water of 4 times of volumes to extract, centrifugal collection supernatant, mixes rear concentrating under reduced pressure, adds 4 ℃ of standing 12h of 70% ethanol of 0.3 times of volume, centrifugal collecting precipitation, 40 ℃ of vacuum dryings obtain Rhizoma Dioscoreae extract.
(5) above-mentioned each extract is dissolved in 1000mL water for injection, adopts existing preparation of injection, make injectable powder.
Embodiment 6
The pharmaceutical composition of the treatment gout that the present embodiment is enumerated, is made up of the medicinal raw material of following weight:
Radix Astragali 12g, Herba Epimedii 15g, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 6g, Rhizoma Dioscoreae 12g.
Aforementioned pharmaceutical compositions is prepared into capsule:
(1) get Milkvetch Root by formula proportion, add the water reflux, extract, three times of 10 times of volumes, extraction time is respectively 2.0,1.5,1.5h, collects merge extractive liquid, concentrated, in the extracting solution after concentrated, thin up, staticly settle, filter, get supernatant concentration and become rare extractum, dry, obtain Radix Astragali extract.
(2) get epimedium herb, add 60% ethanol extraction 3 times of 10 times of volumes, each 2h, collects merge extractive liquid, suitably concentrated, divides 3 extractions by ethyl acetate, merges the ethyl acetate layer of extraction, is dried after reclaiming solvent, obtains Herba Epimedii extract.
(3) get Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) medical material by formula proportion, add 85% alcohol reflux 3h of 10 times of volumes, collect extracting solution, the centrifugal precipitation of removing, vacuum drying supernatant obtains Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) extract.
(4) get Rhizoma Dioscoreae defibrination, add the water of 10 times of volumes, with 30%NaOH solution adjusting pH to 9,2h, centrifugal collection supernatant are extracted in constant temperature (60 ℃) water-bath, in precipitation, again add the water of 8 times of volumes to extract, centrifugal collection supernatant, mixes rear 60 ℃ of concentrating under reduced pressure, adds 4 ℃ of standing 12h of 70% ethanol of 1 times of volume, centrifugal collecting precipitation, 40 ℃ of vacuum dryings obtain Rhizoma Dioscoreae extract.
(5) above-mentioned each extract is mixed homogeneously with starch 100g, adopt capsules preparation technique, make capsule.
Embodiment 7
The pharmaceutical composition of the treatment gout that the present embodiment is enumerated, is made up of the medicinal raw material of following weight:
Radix Astragali 12g, Herba Epimedii 9g, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 6g, Rhizoma Dioscoreae 6g.
Above-mentioned medicinal raw material is prepared into tablet:
(1) get Milkvetch Root by formula proportion, add the ethanol of 10 times of volumes or water reflux, extract, three times, extraction time is respectively 2.0,1.5,1.5h, collects merge extractive liquid, concentrated, in the extracting solution after concentrated, thin up, staticly settle, filter, get supernatant concentration and become rare extractum, dry, obtain Radix Astragali extract.
(2) get epimedium herb, add 95% ethanol extraction 3 times of 10 times of volumes, each 2h, collects merge extractive liquid, suitably concentrated, divides 3 extractions by ethyl acetate, merges the ethyl acetate layer of extraction, is dried after reclaiming solvent, obtains Herba Epimedii extract.
(3) get Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) medical material by formula proportion, add 85% alcohol reflux 3h of 10 times of volumes, collect extracting solution, the centrifugal precipitation of removing, vacuum drying supernatant obtains Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) extract.
(4) get Rhizoma Dioscoreae defibrination, add the water of 10 times of volumes, with 30%NaOH solution adjusting pH to 7,2h, centrifugal collection supernatant are extracted in 60 ℃ of water-baths of constant temperature, in precipitation, again add the water of 4 times of volumes to extract, centrifugal collection supernatant, mixes rear 60 ℃ of concentrating under reduced pressure, adds 4 ℃ of standing 12h of 70% ethanol of 0.5 times of volume, centrifugal collecting precipitation, 40 ℃ of vacuum dryings obtain Rhizoma Dioscoreae extract.
(5) by above-mentioned each extract mix homogeneously, dry, tabletting and get final product after granulating.
Embodiment 8
The pharmaceutical composition of the treatment gout that the present embodiment is enumerated, is made up of the medicinal raw material of following weight:
Radix Astragali 18g, Herba Epimedii 15g, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 12g, Rhizoma Dioscoreae 12g.
Make as follows capsule: get the crude drug of described proportioning, mix, add suitable quantity of water, adopt decocting method to extract 2 times, filter, merge 2 times filtrate, concentrated, dry, after granulation, pack in hungry area softgel shell and get final product.
The various embodiments described above medicine, also can be according to other conventional formulation method, by each crude drug of corresponding weight proportion through other extract and the processing of the method such as purification after, make again the medicine of other dosage form, as: granule, tablet, hard capsule, oral liquid, soft capsule, drop pill, water pill, honeyed pill etc.
In addition, according to the needs of the various drug forms of preparation, the various embodiments described above medicine also can add suitable pharmaceutic adjuvant as magnesium stearate, starch, dextrin, sucrose, microcrystalline Cellulose, hydroxypropyl emthylcellulose, vegetable oil, lecithin, Polyethylene Glycol, propylene glycol, ethyl hydroxybenzoate etc. in preparation process.
Test example
For the efficacy and saferry of proved invention medicine, inventor has carried out pharmacodynamics and toxicity test is investigated.The research method and the result of the test that adopt are as follows:
(1) pharmacodynamics test research
1, test material
(1), medicine and reagent:
Medicine of the present invention is the extract of making according to crude drug weight proportion described in embodiment 4 and method.
Colchicine is Yunnan Plant Pharmaceutical Industry Co., Ltd.'s product.
(2), animal: Kunming mouse, SD rat, provided by Sichuan institute of antibiotics Experimental Animal Center.
2, test method and result
(1) impact on hyperuricemia Mouse Blood uric acid level
Get 60 of Kunming mouses, male and female are all used, body weight 18~22g, be divided at random dosage group (8g raw medicinal herbs/kg), medicine high dose group of the present invention (16g raw medicinal herbs/kg), positive controls in normal saline group, medicine low dose group of the present invention (4g raw medicinal herbs/kg), medicine of the present invention, gavage respectively normal saline, medicine of the present invention and colchicine, every day 1 time, continuously 4d.After last administration 1h, except normal saline group, all the other each treated animal Intraperitoneal injection of hypoxanthine 1mg/kg cause mice hyperuricemia, the capacity blank liquid such as normal saline group injection.0.5h after injection, each treated animal is plucked eyeball and is got blood, and the centrifugal 15min of 3000r/min gets serum and surveys Level of Serum Uric Acid.
The impact of table 1 on hyperuricemia Mouse Blood uric acid level
Note: with model group comparison: * * P<0.01
As can be seen from the table, each group of the high, medium and low dosage of medicine of the present invention all can reduce Mouse Blood uric acid level, relatively has significant difference with model group.