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:
A kind of pharmaceutical composition for the treatment of 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 the used medicine material of pharmaceutical composition of the present invention 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.
The more preferably proportioning of the used medicine material of pharmaceutical composition of the present invention 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 the used medicine material of pharmaceutical composition of the present invention 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 the medicine of any one suitable on pharmaceutics dosage form, preferred granulation agent, tablet, hard capsule, oral liquid, soft capsule, drop pill etc. with each crude drug after treatment according to the formulation method of routine.
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) gets Milkvetch Root by formula proportion, 60% alcohol reflux of 10 times of volumes of adding three times, extraction time is respectively 2.0,1.5,1.5h, collects merge extractive liquid, and concentrated, in the extracting solution after concentrated, thin up, staticly settle, filter, get supernatant concentration and become rare extractum, drying obtains Radix Astragali extract.
(2) get epimedium herb, 95% ethanol extraction of 6 times of volumes of adding 3 times, each 1h collects merge extractive liquid, and also suitably concentrates, and divides 3 extractions with ethyl acetate, merges the ethyl acetate layer of extraction, and is dry behind the recovery solvent, gets Herba Epimedii extract.
(3) get the 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, the vacuum drying supernatant obtains Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) extract.
(4) get the Rhizoma Dioscoreae defibrination, add the water of 10 times of volumes, regulate pH to 7-9 with 30%NaOH solution, 2h is extracted in constant temperature (60-80 ℃) water-bath, centrifugal (3000r/min, 15min) collects supernatant, and the water that again adds 8 times of volumes in the precipitation extracts, centrifugal collection supernatant, concentrating under reduced pressure (60 ℃) after mixing, 4 ℃ of 70% ethanol that add 1 times of volume leave standstill 12h, centrifugal (3000r/min, 30min) collecting precipitation, 40 ℃ of vacuum dryings get 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 such as filler, disintegrating agent, binding agent, lubricant, antiseptic etc. in preparation process.
The used various raw medicinal materials of the present invention 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, have 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; The Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) acrid in the mouth, warm in nature, poisonous, have drying dampness to eliminate phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, the function of dissolving lump and resolving mass; The Rhizoma Dioscoreae sweet in the mouth, the function that property is flat to have spleen reinforcing, support lung, reinforce the kidney, benefit is smart.More than 4 flavor Chinese medicine composition use, have the Synergistic function, be used for the treatment of gout, determined curative effect shows through clinical research, it is better that medicine of the present invention is used for the treatment of the gout curative effect, and do not find obvious side effect and untoward reaction.
The specific embodiment
The present invention is described in further detail below in conjunction with the specific embodiment.
Embodiment 1
The pharmaceutical composition of the treatment gout that present embodiment is enumerated is comprised 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.
As follows granulation agent: get the crude drug of described proportioning, add respectively suitable quantity of water, adopt decocting method to extract respectively 2 times, filter, merges 2 times filtrate, concentrated after with each concentrated solution mix homogeneously, drying is distributed into after the granulation bag and get final product.
Embodiment 2
The pharmaceutical composition of the treatment gout that present embodiment is enumerated is comprised 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.
As follows granulation agent: get the crude drug of described proportioning, add respectively an amount of 70% ethanol, adopt reflux extraction to extract respectively 3 times, filter, merge 3 times filtrate, Recycled ethanol and concentrate after with each concentrated solution mix homogeneously, drying, be distributed into after the granulation bag and get final product.
Embodiment 3
The pharmaceutical composition of the treatment gout that present embodiment is enumerated is comprised 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.
By the following method granulation agent:
(1) gets Milkvetch Root by formula proportion, 60% alcohol reflux of 10 times of volumes of adding three times, extraction time is respectively 2.0,1.5,1.5h, collects merge extractive liquid, and concentrated, in the extracting solution after concentrated, thin up, staticly settle, filter, get supernatant concentration and become rare extractum, drying obtains Radix Astragali extract.
(2) get epimedium herb, 95% ethanol extraction of 6 times of volumes of adding 3 times, each 1h collects merge extractive liquid, and also suitably concentrates, and divides 3 extractions with ethyl acetate, merges the ethyl acetate layer of extraction, and is dry behind the recovery solvent, gets Herba Epimedii extract.
(3) get the 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, the vacuum drying supernatant obtains Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) extract.
(4) get the Rhizoma Dioscoreae defibrination, the water that adds 10 times of volumes, regulate pH to 9 with 30%NaOH solution, 2h, centrifugal collection supernatant are extracted in 70 ℃ of water-baths of constant temperature, the water that again adds 8 times of volumes in the precipitation extracts, centrifugal collection supernatant mixes rear 60 ℃ of concentrating under reduced pressure, and 4 ℃ of 70% ethanol that add 1 times of volume leave standstill 12h, centrifugal collecting precipitation, 40 ℃ of vacuum dryings get Rhizoma Dioscoreae extract.
(5) get above-mentioned each extract and mix evenly, drying is distributed into bag after the granulation, the granulation agent.
Embodiment 4
The pharmaceutical composition of the treatment gout that present embodiment is enumerated is comprised 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) gets Milkvetch Root by formula proportion, 95% alcohol reflux of 8 times of volumes of adding three times, extraction time is respectively 2.0,1.5,1.5h, collects merge extractive liquid, and concentrated, in the extracting solution after concentrated, thin up, staticly settle, filter, get supernatant concentration and become rare extractum, drying obtains Radix Astragali extract.
(2) get epimedium herb, 95% ethanol extraction of 6 times of volumes of adding 3 times, each 1h collects merge extractive liquid, and also suitably concentrates, and divides 3 extractions with ethyl acetate, merges the ethyl acetate layer of extraction, and is dry behind the recovery solvent, gets Herba Epimedii extract.
(3) get the 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, the vacuum drying supernatant obtains Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) extract.
(4) get the Rhizoma Dioscoreae defibrination, the water that adds 10 times of volumes, regulate pH to 9 with 30%NaOH solution, 2h, centrifugal collection supernatant are extracted in constant temperature (60-80 ℃) water-bath, the water that again adds 8 times of volumes in the precipitation extracts, centrifugal collection supernatant, concentrating under reduced pressure (60 ℃) after mixing, 4 ℃ of 70% ethanol that add 0.3 times of volume leave standstill 12h, centrifugal collecting precipitation, 40 ℃ of vacuum dryings get Rhizoma Dioscoreae extract.
(5) above-mentioned each extract is mixed, add vegetable oil 25g, mixing is made capsule casing material with gelatin, is pressed into soft capsule.
Embodiment 5
The pharmaceutical composition of the treatment gout that present embodiment is enumerated is comprised 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) gets Milkvetch Root by formula proportion, the ethanol of 8 times of volumes of adding or water reflux, extract, three times, extraction time is respectively 2.0,1.5,1.5h, collects merge extractive liquid, and concentrated, in the extracting solution after concentrated, thin up, staticly settle, filter, get supernatant concentration and become rare extractum, drying obtains Radix Astragali extract.
(2) get epimedium herb, 60% ethanol extraction of 6 times of volumes of adding 3 times, each 2h collects merge extractive liquid, and also suitably concentrates, and divides 3 extractions with ethyl acetate, merges the ethyl acetate layer of extraction, and is dry behind the recovery solvent, gets Herba Epimedii extract.
(3) get the 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, the vacuum drying supernatant obtains Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) extract.
(4) get the Rhizoma Dioscoreae defibrination, the water that adds 8 times of volumes, regulate pH to 7 with 30%NaOH solution, 2h, centrifugal collection supernatant are extracted in 60 ℃ of water-baths of constant temperature, the water that again adds 4 times of volumes in the precipitation extracts, centrifugal collection supernatant, concentrating under reduced pressure after mixing, 4 ℃ of 70% ethanol that add 0.3 times of volume leave standstill 12h, centrifugal collecting precipitation, 40 ℃ of vacuum dryings get Rhizoma Dioscoreae extract.
(5) above-mentioned each extract is dissolved in the 1000mL water for injection, adopts existing preparation of injection, make injectable powder.
Embodiment 6
The pharmaceutical composition of the treatment gout that present embodiment is enumerated is comprised 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) gets Milkvetch Root by formula proportion, the water reflux, extract, of 10 times of volumes of adding three times, extraction time is respectively 2.0,1.5,1.5h, collects merge extractive liquid, and concentrated, in the extracting solution after concentrated, thin up, staticly settle, filter, get supernatant concentration and become rare extractum, drying obtains Radix Astragali extract.
(2) get epimedium herb, 60% ethanol extraction of 10 times of volumes of adding 3 times, each 2h collects merge extractive liquid, and also suitably concentrates, and divides 3 extractions with ethyl acetate, merges the ethyl acetate layer of extraction, and is dry behind the recovery solvent, gets Herba Epimedii extract.
(3) get the 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, the vacuum drying supernatant obtains Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) extract.
(4) get the Rhizoma Dioscoreae defibrination, the water that adds 10 times of volumes, regulate pH to 9 with 30%NaOH solution, 2h, centrifugal collection supernatant are extracted in constant temperature (60 ℃) water-bath, the water that again adds 8 times of volumes in the precipitation extracts, centrifugal collection supernatant mixes rear 60 ℃ of concentrating under reduced pressure, and 4 ℃ of 70% ethanol that add 1 times of volume leave standstill 12h, centrifugal collecting precipitation, 40 ℃ of vacuum dryings get Rhizoma Dioscoreae extract.
(5) with above-mentioned each extract and starch 100g mix homogeneously, adopt capsules preparation technique, make capsule.
Embodiment 7
The pharmaceutical composition of the treatment gout that present embodiment is enumerated is comprised 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) gets Milkvetch Root by formula proportion, the ethanol of 10 times of volumes of adding or water reflux, extract, three times, extraction time is respectively 2.0,1.5,1.5h, collects merge extractive liquid, and concentrated, in the extracting solution after concentrated, thin up, staticly settle, filter, get supernatant concentration and become rare extractum, drying obtains Radix Astragali extract.
(2) get epimedium herb, 95% ethanol extraction of 10 times of volumes of adding 3 times, each 2h collects merge extractive liquid, and also suitably concentrates, and divides 3 extractions with ethyl acetate, merges the ethyl acetate layer of extraction, and is dry behind the recovery solvent, gets Herba Epimedii extract.
(3) get the 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, the vacuum drying supernatant obtains Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) extract.
(4) get the Rhizoma Dioscoreae defibrination, the water that adds 10 times of volumes, regulate pH to 7 with 30%NaOH solution, 2h, centrifugal collection supernatant are extracted in 60 ℃ of water-baths of constant temperature, the water that again adds 4 times of volumes in the precipitation extracts, centrifugal collection supernatant mixes rear 60 ℃ of concentrating under reduced pressure, and 4 ℃ of 70% ethanol that add 0.5 times of volume leave standstill 12h, centrifugal collecting precipitation, 40 ℃ of vacuum dryings get Rhizoma Dioscoreae extract.
(5) above-mentioned each extract is mixed evenly drying, tabletting and get final product after granulating.
Embodiment 8
The pharmaceutical composition of the treatment gout that present embodiment is enumerated is comprised 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, merges 2 times filtrate, concentrate, drying is in the hungry area softgel shell of packing into after the granulation and get final product.
The various embodiments described above medicine, also can be according to other conventional formulation method, with each crude drug of corresponding weight proportion through other extract and the method processing 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 such 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, the 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:
The extract of medicine of the present invention for making according to embodiment 4 described crude drug weight proportions and method.
Colchicine is Yunnan Plant Pharmaceutical Industry Co., Ltd.'s product.
(2), animal: Kunming mouse, SD rat are provided by institute of antibiotics, Sichuan Experimental Animal Center.
2, test method and result
(1) on the impact of 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 normal saline group, medicine low dose group of the present invention (dosage group in 4g raw medicinal herbs/kg), the medicine of the present invention (8g raw medicinal herbs/kg), medicine high dose group of the present invention (16g raw medicinal herbs/kg), positive controls, gavage respectively normal saline, medicine of the present invention and colchicine, every day 1 time, continuously 4d.Behind the last administration 1h, except the normal saline group, all the other each treated animal Intraperitoneal injection of hypoxanthine 1mg/kg cause the mice hyperuricemia, the capacity blank liquid such as normal saline group injection.0.5h after the 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.
Table 1 is on the impact of hyperuricemia Mouse Blood uric acid level
Annotate: compare with model group: * * 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 the Mouse Blood uric acid level, with model group significant difference is arranged relatively.