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 Folium Perillae, Radix Ranunculi Ternati, Rhizoma Chuanxiong and Radix Glycyrrhizae.
The weight proportion of the used medicine material of pharmaceutical composition of the present invention can be Folium Perillae 20-30 part, Radix Ranunculi Ternati 4-12 part, Rhizoma Chuanxiong 2-8 part, Radix Glycyrrhizae 1-6 part.
The more preferably proportioning of the used medicine material of pharmaceutical composition of the present invention is: Folium Perillae 22-28 part, Radix Ranunculi Ternati 6-10 part, Rhizoma Chuanxiong 3-6 part, Radix Glycyrrhizae 2-4 part.
The best proportioning of the used medicine material of pharmaceutical composition of the present invention is: 25 parts of Folium Perillaes, 8 parts of Radix Ranunculi Ternatis, 5 parts of Rhizoma Chuanxiongs, 3 parts in Radix Glycyrrhizae.
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 the Folium Perillae medical material 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 Folium perillae extract.
(2) get dry Radix Ranunculi Ternati, pulverize, cross 60 mesh sieves, add 70% ethanol extraction of 8-10 times of volume, extract 3 times, each 1.5-2h collects merge extractive liquid, and concentrated, and drying gets Radix Ranunculi Ternati extract.
(3) get Ligusticum chuanxiong Hort, with the 60-95% alcohol reflux of 8-10 times of volume 3 times, each 1.5h, extracting liquid filtering, merging filtrate, concentrating under reduced pressure, get extractum, be dissolved in water sucking filtration, filtrate is crossed macroporous resin column (volume ratio of extractum and resin is 1:15-1:20), washes with water first, and this water elution liquid is discarded need not, then use 30% ethanol elution, merge 30% ethanol elution, decompression recycling ethanol, vacuum drying gets Rhizoma Chuanxiong extract.
(4) extracting liquorice medical material adds the water boiling and extraction 2 times of 8-10 times of volume, each 1.5-2h, and merge extractive liquid,, concentrated, dry, get Radix Glycyrrhizae 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 Folium Perillae has invigorating QI to consolidate the body surface resistance, the function of inducing diuresis to remove edema; Radix Ranunculi Ternati sweet in the mouth, suffering, warm in nature.Mass dissipating and swelling eliminating.The Rhizoma Chuanxiong acrid in the mouth is warm in nature, blood circulation promoting and blood stasis dispelling, activating QI to alleviate the depression, wind-expelling pain-stopping.The invigorating middle warmer of Radix Glycyrrhizae QI invigorating, the function of heat-clearing and toxic substances removing, the mediation property of medicine.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:
Folium Perillae 15g, Radix Ranunculi Ternati 12g, Rhizoma Chuanxiong 10g, Radix Glycyrrhizae 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:
Folium Perillae 15g, Radix Ranunculi Ternati 12g, Rhizoma Chuanxiong 10g, Radix Glycyrrhizae 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:
Folium Perillae 15g, Radix Ranunculi Ternati 12g, Rhizoma Chuanxiong 10g, Radix Glycyrrhizae 8g.
By the following method granulation agent:
(1) gets the Folium Perillae medical material 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 Folium perillae extract.
(2) get dry Radix Ranunculi Ternati, pulverize, cross 60 mesh sieves, add 70% ethanol extraction of 9 times of volumes, extract 3 times, each 2h collects merge extractive liquid, and concentrated, and drying gets Radix Ranunculi Ternati extract.
(3) get Ligusticum chuanxiong Hort, with 85% alcohol reflux of 9 times of volumes 3 times, each 1.5h, extracting liquid filtering, merging filtrate, concentrating under reduced pressure, get extractum, be dissolved in water sucking filtration, filtrate is crossed macroporous resin column (volume ratio of extractum and resin is 1:15), washes with water first, and this water elution liquid is discarded need not, then use 30% ethanol elution, merge 30% ethanol elution, decompression recycling ethanol, vacuum drying gets Rhizoma Chuanxiong extract.
(4) extracting liquorice medical material adds the water boiling and extraction 2 times of 9 times of volumes, each 1.5h, and merge extractive liquid,, concentrated, dry, get Radix Glycyrrhizae 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:
Folium Perillae 9g, Radix Ranunculi Ternati 8g, Rhizoma Chuanxiong 3g, Radix Glycyrrhizae 3g.
Be prepared into by the following method soft capsule:
(1) gets the Folium Perillae medical material 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 Folium perillae extract.
(2) get dry Radix Ranunculi Ternati, pulverize, cross 60 mesh sieves, add 70% ethanol extraction of 10 times of volumes, extract 3 times, each 2h collects merge extractive liquid, and concentrated, and drying gets Radix Ranunculi Ternati extract.
(3) get Ligusticum chuanxiong Hort, with 95% alcohol reflux of 10 times of volumes 3 times, each 1.5h, extracting liquid filtering, merging filtrate, concentrating under reduced pressure, get extractum, be dissolved in water sucking filtration, filtrate is crossed macroporous resin column (volume ratio of extractum and resin is 1:20), washes with water first, and this water elution liquid is discarded need not, then use 30% ethanol elution, merge 30% ethanol elution, decompression recycling ethanol, vacuum drying gets Rhizoma Chuanxiong extract.
(4) extracting liquorice medical material adds the water boiling and extraction 2 times of 10 times of volumes, each 2h, and merge extractive liquid,, concentrated, dry, get Radix Glycyrrhizae 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:
Folium Perillae 21g, Radix Ranunculi Ternati 18g, Rhizoma Chuanxiong 15g, Radix Glycyrrhizae 15g.
(1) gets the Folium Perillae medical material 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 Folium perillae extract.
(2) get dry Radix Ranunculi Ternati, pulverize, cross 60 mesh sieves, add 70% ethanol extraction of 8 times of volumes, extract 3 times, each 1.5h collects merge extractive liquid, and concentrated, and drying gets Radix Ranunculi Ternati extract.
(3) get Ligusticum chuanxiong Hort, with 60% alcohol reflux of 8 times of volumes 3 times, each 1.5h, extracting liquid filtering, merging filtrate, concentrating under reduced pressure, get extractum, be dissolved in water sucking filtration, filtrate is crossed macroporous resin column (volume ratio of extractum and resin is 1:15), washes with water first, and this water elution liquid is discarded need not, then use 30% ethanol elution, merge 30% ethanol elution, decompression recycling ethanol, vacuum drying gets Rhizoma Chuanxiong extract.
(4) extracting liquorice medical material adds the water boiling and extraction 2 times of 8 times of volumes, each 1.5h, and merge extractive liquid,, concentrated, dry, get Radix Glycyrrhizae 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:
Folium Perillae 12g, Radix Ranunculi Ternati 15g, Rhizoma Chuanxiong 6g, Radix Glycyrrhizae 12g.
Aforementioned pharmaceutical compositions is prepared into capsule:
(1) gets the Folium Perillae medical material 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 Folium perillae extract.
(2) get dry Radix Ranunculi Ternati, pulverize, cross 60 mesh sieves, add 70% ethanol extraction of 8 times of volumes, extract 3 times, each 2h collects merge extractive liquid, and concentrated, and drying gets Radix Ranunculi Ternati extract.
(3) get Ligusticum chuanxiong Hort, with 75% alcohol reflux of 10 times of volumes 3 times, each 1.5h, extracting liquid filtering, merging filtrate, concentrating under reduced pressure, get extractum, be dissolved in water sucking filtration, filtrate is crossed macroporous resin column (volume ratio of extractum and resin is 1:20), washes with water first, and this water elution liquid is discarded need not, then use 30% ethanol elution, merge 30% ethanol elution, decompression recycling ethanol, vacuum drying gets Rhizoma Chuanxiong extract.
(4) extracting liquorice medical material adds the water boiling and extraction 2 times of 10 times of volumes, each 2h, and merge extractive liquid,, concentrated, dry, get Radix Glycyrrhizae 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:
Folium Perillae 12g, Radix Ranunculi Ternati 9g, Rhizoma Chuanxiong 6g, Radix Glycyrrhizae 6g.
Above-mentioned medicinal raw material is prepared into tablet:
(1) gets the Folium Perillae medical material 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 Folium perillae extract.
(2) get dry Radix Ranunculi Ternati, pulverize, cross 60 mesh sieves, add 70% ethanol extraction of 8 times of volumes, extract 3 times, each 1.5h collects merge extractive liquid, and concentrated, and drying gets Radix Ranunculi Ternati extract.
(3) get Ligusticum chuanxiong Hort, with 75% alcohol reflux of 9 times of volumes 3 times, each 1.5h, extracting liquid filtering, merging filtrate, concentrating under reduced pressure, get extractum, be dissolved in water sucking filtration, filtrate is crossed macroporous resin column (volume ratio of extractum and resin is 1:170), washes with water first, and this water elution liquid is discarded need not, then use 30% ethanol elution, merge 30% ethanol elution, decompression recycling ethanol, vacuum drying gets Rhizoma Chuanxiong extract.
(4) extracting liquorice medical material adds the water boiling and extraction 2 times of 9 times of volumes, each 1.5h, and merge extractive liquid,, concentrated, dry, get Radix Glycyrrhizae 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:
Folium Perillae 18g, Radix Ranunculi Ternati 15g, Rhizoma Chuanxiong 12g, Radix Glycyrrhizae 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
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 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.