Summary of the invention
The invention provides a kind of new Chinese medicine composition, said composition has the effect of heat clearing and damp drying, detoxifcation, diuretic, easing joint movement, is used for the treatment of gout.
Another object of the present invention provides the preparation method of above-mentioned Chinese medicine composition.
The present invention is achieved by the following technical solutions:
The present invention is made by the following weight proportion raw material: Rhizoma Smilacis Glabrae 15-60 part, Radix Cyathulae 4.5-9 part, Cortex Phellodendri 3-12 part, Radix Et Rhizoma Rhei 3-30 part, Cortex Fraxini 6-12 part, Radix Gentianae Macrophyllae 3-9 part, Rhizoma Alismatis 6-9 part, Semen Plantaginis 9-15 part.
Preferred weight portion proportioning is: 30 parts of Rhizoma Smilacis Glabraes, 6 parts of Radix Cyathulaes, 9 parts of Cortex Phellodendris, 6 parts of Radix Et Rhizoma Rhei, 9 parts of Cortex Fraxinis, 6 parts of Radix Gentianae Macrophyllae, 6 parts of Rhizoma Alismatis, 12 parts of Semen Plantaginiss.
The preparation method of Chinese medicine composition of the present invention is as follows:
Above medical material adds 8 times of amount 70% ethanol extractions, extract 2 times, each 1-1.5 hour, being concentrated into relative density is the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), promptly get extract, add appropriate amount of auxiliary materials, be prepared into pharmaceutically acceptable oral formulations, for example capsule, tablet, pill, drop pill etc.
The preparation method of the preferred pill of Chinese medicine composition of the present invention is as follows:
Extract is ground into fine powder, adds proper honey, evenly mixed, the pill agent.
The preparation method of Chinese medicine composition preferred capsule of the present invention agent is as follows:
Extract is ground into fine powder, adds lactose, mixing is used 95% alcohol granulation, and drying incapsulates, and promptly gets capsule.
The preparation method of the preferred tablet of Chinese medicine composition of the present invention is as follows:
Extract is ground into fine powder, adds lactose, mixing is granulated, drying, and the adding magnesium stearate is an amount of, mixing, tabletting, coating promptly gets tablet.
The compatibility mechanism of pharmaceutical composition of the present invention is as follows:
The traditional Chinese medical science thinks that the joint meridians that stagnate flow by the resistance of the turbid damp stasis of blood in gout system, and due to QI and blood was smooth, non-general ailment said due to cold or exposure was done.The heresy of turbid damp, non-be subjected in outside, and in main being born in.General patient with gout is mainly in middle-aged and elderly people, plump people, its internal organs degradation, if having a liking for the food greasy and surfeit flavour, infringement function of a specified duration is the most outstanding to damage the pure and impure metabolic function of spleen kidney especially.Dysfunction of the spleen in transportation, ascending the clear and descending the turbid is had no right, the weary gasification of kidney, separating clear and excreting turbid mistake department, water paddy is reforming not, gives birth in the turbid poison, is detained in the blood, with the capable distribution of blood, a series of pathological changes takes place.Diseases such as gouty arthritis are the marks of disease, purine metabolism obstacle (the pure and impure metabolism of spleen kidney) is not normal is only disease this, the turbid poison of uric acid is the middle pathological product of pathological changes, and produces disease such as gouty arthritis thus.
The inventor thinks that the cause of disease of gout mainly is that institute causes by " give birth in damp and hot, the turbid poison, diseases caused by retention of fluid is stagnated ", so the rule of treatment is worked as based on heat clearing and damp drying, detoxifcation, diuretic, easing joint movement.
In the drug composition, the mechanism of action of each medicine is as follows in the present invention:
Rhizoma Smilacis Glabrae: sweet, light, flat.Return liver, stomach warp.Dehumidifying, detoxifcation, easing joint movement.Be used for damp and hot stranguria with turbid discharge, leukorrhagia, carbuncle, the limbs contracture due to the scrofula, scabies, syphilis and mercurialism, bones and muscles pain.
Radix Cyathulae: sweet, little hardship, flat.Return liver, kidney channel.Eliminating blood stasis and inducing menstruation, easing joint movement, inducing diuresis for treating stranguria syndrome.Be used for amenorrhea and mass in the abdomen, retention of placenta, arthralgia, flaccidity of the lower limbs clonic spasm of the muscle, hematuria stranguria with blood, injury from falling down.
Cortex Phellodendri: hardship, cold.Return kidney, urinary bladder channel.Heat clearing and damp drying, pathogenic fire purging are removed and are steamed, and skin ulcer is treated in detoxifcation.Be used for damp-heat dysentery, jaundice, leukorrhagia, pyretic stranguria, beriberi, flaccidity is warded off, hectic fever due to YIN-deficiency consumptive fever, night sweat, seminal emission, sore swollen toxin, eczema pruritus.The stir-baked CORTEX PHELLODENDRI with salt solution nourishing YIN to lower pathogenic fire.Be used for hyperactivity of fire caused by deficiency of YIN, the night sweat hectic fever due to YIN-deficiency.
Radix Et Rhizoma Rhei: hardship, cold.Return spleen, stomach, large intestine, liver, pericardium channel.Purging heat and dredging bowels, removing pathogenic heat from blood and toxic substance from the body, eliminating blood stasis and inducing menstruation.Be used for the excess-heat constipation, stagnant stomachache, dysentery is not well, jaundice due to damp-heat, heat in blood is told nosebleed, conjunctival congestion, pharyngeal swelling, abdominalgia with intestinal abscess, carbuncle furuncle, blood stasis amenorrhea, traumatic injury, external treatment burn due to hot liquid or fire; Upper gastrointestinal hemorrhage.Radix et Rhizoma Rhei (stir-fried with wine) is apt to clear part of the body cavity above the diaphragm housing the heart and lungs noxious heat in the blood system.Be used for the conjunctival congestion pharyngeal swelling, gingivitis.Radix Et Rhizoma Rhei rushes down exerts oneself to delay eliminating fire and detoxication.Be used for pathogenic fire,toxin and furuncles.The hemostasis of charred Radix Et Rhizoma Rhei cooling blood and removing stasis.Be used for heat in blood stasis of blood hemorrhage is arranged.
Cortex Fraxini: bitter, puckery, cold.Return liver, gallbladder, large intestine channel.Heat clearing and damp drying, astringent therapy makes eye bright.Be used for hematodiarrhoea, have loose bowels, leucorrhea with red and white discharge, conjunctival congestion and swelling pain, order is given birth to the nebula film.
Radix Gentianae Macrophyllae: hot, bitter, flat.Return stomach, liver, gallbladder meridian.Wind-damp dispelling, clearing away damp-heat, stopping numbness pain.Be used for rheumatic arthralgia, the contracture of muscle arteries and veins, joint is ached, afternoon fever, infantile malnutrition heating.
Rhizoma Alismatis: sweet, cold.Return kidney, urinary bladder channel.Diuresis, clearing away damp-heat.Be used for dysuria, edema distension, the oliguria of having loose bowels, dizziness due to fluid-retention, the puckery pain of pyretic stranguria; Hyperlipidemia.
Semen Plantaginis: sweet, be slightly cold.Return liver, kidney, lung, small intestine meridian.Clearing away heat and promoting diuresis, eliminating dampness by diuresis is treating stranguria, makes eye bright, and eliminates the phlegm.Be used for the edema distension, the puckery pain of pyretic stranguria, diarrhea due to summer heat and dampness, conjunctival congestion and swelling pain, phlegm-heat cough.
In the present invention in the drug composition with Rhizoma Smilacis Glabrae as monarch drug, bring into play the effect of its dehumidifying, detoxifcation, easing joint movement, Cortex Phellodendri, Radix Et Rhizoma Rhei are as ministerial drug, play the effect of heat clearing and damp drying, removing pathogenic heat from blood and toxic substance from the body, Rhizoma Alismatis, Semen Plantaginis make for assistant altogether, get the effect of its clearing away heat and promoting diuresis, Cortex Fraxini, Radix Gentianae Macrophyllae are strengthened the effect of heat clearing and damp drying, Radix Cyathulae is strengthened the effect of easing joint movement, and eight medicines are harmonious, and play the effect of heat clearing and damp drying, detoxifcation, diuretic, easing joint movement altogether.
Below, foregoing of the present invention is described in further detail by the specific embodiment:
Concrete embodiment
Embodiment 1:
Rhizoma Smilacis Glabrae 30kg, Radix Cyathulae 6kg, Cortex Phellodendri 9kg, Radix Et Rhizoma Rhei 6kg, Cortex Fraxini 9kg, Radix Gentianae Macrophyllae 6kg, Rhizoma Alismatis 6kg, Semen Plantaginis 12kg
Above medical material adds 8 times of amount 70% ethanol extractions, extracts 2 times, and each 1 hour, being concentrated into relative density was the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), promptly get extract;
Extract is ground into fine powder, adds proper honey, evenly mixed, the pill agent.
Embodiment 2:
Rhizoma Smilacis Glabrae 20kg, Radix Cyathulae 6kg, Cortex Phellodendri 9kg, Radix Et Rhizoma Rhei 6kg, Cortex Fraxini 9kg, Radix Gentianae Macrophyllae 6kg, Rhizoma Alismatis 6kg, Semen Plantaginis 12kg
Above medical material adds 8 times of amount 70% ethanol extractions, extracts 2 times, and each 1 hour, being concentrated into relative density was the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), promptly get extract;
Extract is ground into fine powder, adds the 40kg lactose, mixing is used 95% alcohol granulation, and drying incapsulates, and promptly gets capsule.
Embodiment 3:
Rhizoma Smilacis Glabrae 30kg, Radix Cyathulae 9kg, Cortex Phellodendri 9kg, Radix Et Rhizoma Rhei 6kg, Cortex Fraxini 9kg, Radix Gentianae Macrophyllae 6kg, Rhizoma Alismatis 6kg, Semen Plantaginis 12kg
Above medical material adds 8 times of amount 70% ethanol extractions, extracts 2 times, and each 1 hour, being concentrated into relative density was the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), promptly get extract;
Extract is ground into fine powder, adds the 40kg lactose, mixing is granulated, drying, and the adding magnesium stearate is an amount of, mixing, tabletting, coating promptly gets tablet.
Embodiment 4:
Rhizoma Smilacis Glabrae 30kg, Radix Cyathulae 6kg, Cortex Phellodendri 12kg, Radix Et Rhizoma Rhei 6kg, Cortex Fraxini 9kg, Radix Gentianae Macrophyllae 6kg, Rhizoma Alismatis 6kg, Semen Plantaginis 12kg
Above medical material adds 8 times of amount 70% ethanol extractions, extracts 2 times, and each 1 hour, being concentrated into relative density was the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), promptly get extract;
Extract is ground into fine powder, adds proper honey, evenly mixed, the pill agent.
Embodiment 5:
Rhizoma Smilacis Glabrae 30kg, Radix Cyathulae 6kg, Cortex Phellodendri 9kg, Radix Et Rhizoma Rhei 12kg, Cortex Fraxini 9kg, Radix Gentianae Macrophyllae 6kg, Rhizoma Alismatis 6kg, Semen Plantaginis 12kg
Above medical material adds 8 times of amount 70% ethanol extractions, extracts 2 times, and each 1 hour, being concentrated into relative density was the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), promptly get extract;
Extract is ground into fine powder, adds the 40kg lactose, mixing is used 95% alcohol granulation, and drying incapsulates, and promptly gets capsule.
Embodiment 6:
Rhizoma Smilacis Glabrae 30kg, Radix Cyathulae 6kg, Cortex Phellodendri 9kg, Radix Et Rhizoma Rhei 6kg, Cortex Fraxini 12kg, Radix Gentianae Macrophyllae 6kg, Rhizoma Alismatis 6kg, Semen Plantaginis 12kg
Above medical material adds 8 times of amount 70% ethanol extractions, extracts 2 times, and each 1 hour, being concentrated into relative density was the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), promptly get extract;
Extract is ground into fine powder, adds the 40kg lactose, mixing is granulated, drying, and the adding magnesium stearate is an amount of, mixing, tabletting, coating promptly gets tablet.
Embodiment 7:
Rhizoma Smilacis Glabrae 30kg, Radix Cyathulae 6kg, Cortex Phellodendri 9kg, Radix Et Rhizoma Rhei 6kg, Cortex Fraxini 9kg, Radix Gentianae Macrophyllae 9kg, Rhizoma Alismatis 6kg, Semen Plantaginis 12kg
Above medical material adds 8 times of amount 70% ethanol extractions, extracts 2 times, and each 1 hour, being concentrated into relative density was the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), promptly get extract;
Extract is ground into fine powder, adds proper honey, evenly mixed, the pill agent.
Embodiment 8:
Rhizoma Smilacis Glabrae 30kg, Radix Cyathulae 6kg, Cortex Phellodendri 9kg, Radix Et Rhizoma Rhei 6kg, Cortex Fraxini 9kg, Radix Gentianae Macrophyllae 6kg, Rhizoma Alismatis 9kg, Semen Plantaginis 12kg
Above medical material adds 8 times of amount 70% ethanol extractions, extracts 2 times, and each 1 hour, being concentrated into relative density was the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), promptly get extract;
Extract is ground into fine powder, adds the 40kg lactose, mixing is used 95% alcohol granulation, and drying incapsulates, and promptly gets capsule.
Embodiment 9:
Rhizoma Smilacis Glabrae 30kg, Radix Cyathulae 6kg, Cortex Phellodendri 9kg, Radix Et Rhizoma Rhei 6kg, Cortex Fraxini 9kg, Radix Gentianae Macrophyllae 6kg, Rhizoma Alismatis 6kg, Semen Plantaginis 15kg
Above medical material adds 8 times of amount 70% ethanol extractions, extracts 2 times, and each 1 hour, being concentrated into relative density was the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), promptly get extract;
Extract is ground into fine powder, adds the 40kg lactose, mixing is granulated, drying, and the adding magnesium stearate is an amount of, mixing, tabletting, coating promptly gets tablet.
Further set forth the beneficial effect of pharmaceutical composition of the present invention by following experiment:
The laboratory observation of traditional Chinese medicine composition for treating rat gout model of the present invention
1 materials and methods
1.1 laboratory animal and grouping
30 of Wistar cleaning level male rats, body weight 200-250g is divided into normal group, gout model group and Chinese herb prevention group at random, 10 every group.
1.2 the preparation of urate crystal
With reference to the Seemiller method, uric acid (Uric acid) is dissolved in the NaOH solution of 1mol/L, adjust pH with HCl, through stirring, filtration, cold drying, screening, sterilize, be prepared into aseptic urate crystal.
1.3 gout Preparation of model
The scorching animal model of experimental uric acid salt ankle joint is made with reference to Coderre TJ and the improvement of Chen Shi method and is carried out.With sterile working's method, with No. 4 injection needles,, inject the articulatio tibiotarsalis intracavity of gout model group and Chinese herb prevention group rat right hind leg internal malleolus with 5% urate solution, 50 μ l, each animal is only injected 1 time.
1.4 medicine
Treatment group rat is raised with Chinese medicine composition medicinal liquid of the present invention, with 10 times of amounts of per kilogram of body weight of people, 4h left and right sides gastric infusion after modeling in the preparation of gout model.Every big filling stomach 1 time, 3d continuously.Normal group and gout model group rat are irritated isopyknic normal saline.
1.5 observation index
1.5.1 general signs
Observe the outward appearance of rat right hind leg internal malleolus articulatio tibiotarsalis, the active situation of limbs etc.
1.5.2 the K+ concentration of right side ankle joint and surrounding tissue thereof
After modeling the 4th day, the sacrificed by decapitation animal is got hot-tempered joint, right side and surrounding tissue thereof, weighs, homogenate, centrifuging and taking supernatant, with the K+ concentration of the U.S. SYNCHRON EL-ISE of Beckman company analysis-e/or determining tissue.
1.5.3 the tissue pathologies change of right side ankle joint and surrounding tissue thereof
Get right side ankle joint and surrounding tissue thereof, make light microscopic and detect.With conventional method with specimen fix, decalcification, paraffin embedding, section, HE dyeing.
2 results
2.1 general signs
Gout model group and treatment rat, after being injected urate solution about the 2nd day (about 24h), the articulatio tibiotarsalis of internal malleolus has occurred all that ankle swelling in various degree, slow, the sufficient pawl of walking are curled, limbs are reluctant to put forth effort to bear a heavy burden, and individual animal hind leg occurs and excessively bows in the wrongly, even walks lamely.After the modeling day, treatment was organized right ankle swelling and is disappeared obviously, various signs on the whole, the gout model group overweights the treatment group.
2.2 the K+ concentration of right side ankle joint and surrounding tissue thereof
The K+ concentration of gout model group ankle joint and surrounding tissue thereof is apparently higher than normal group (p<0.05), and no tangible difference (table 1) between treatment group and the normal group.
The K+ concentration of table 1 ankle joint and surrounding tissue thereof (x ± S)
Compare * p<0.05 with normal group
2.3 the tissue pathologies change of ankle joint and surrounding tissue thereof
Normal group: ankle joint and structures surrounding thereof are normally clear, do not have any tissue pathologies change.
The gout model group: finding during topography has the urate crystal calmness in the ankle joint intracavity.The visible down significantly arthritis pathology of light microscopic changes, there is tangible foreign body granuloma to form around the tibia shank, show as the more foreign body multinucleated giant cell of appearance in the foreign body granuloma tissue, newborn little vascularization and more fibroblast, local cartilaginous tissue is destroyed.
Treatment group: the urate crystal calmness is arranged in the ankle joint intracavity.Visible arthritis pathology changes under the light microscopic, and the foreign body multinucleated giant cell is less sees, has newborn little vascularization and the local cartilaginous tissue of less fibroblast that destruction is also arranged.But on the population structure, significantly better than the gout model group, what have has almost recovered normal.
3 these experimental results of conclusion have pointed out utilization Chinese medicine composition of the present invention to be used for the treatment of the rat acute gout model that caused by the local injection urate, can obtain comparatively satisfied effect.General signs takes a turn for the better, the PATHOMORPHOLOGICAL OBSERVATION OF PULLORUM that the swelling of ankle joint has the K+ concentration of significantly disappear joint and surrounding tissue thereof obviously to reduce tissue also shows, the pathological change of treatment group arthritis compares with the gout model group, improves significantly on population structure.Chinese medicine composition of the present invention can effectively be treated gout.