CN1803177A - Chinese medicinal composition for treating gout and its preparing process - Google Patents
Chinese medicinal composition for treating gout and its preparing process Download PDFInfo
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- CN1803177A CN1803177A CN 200510023218 CN200510023218A CN1803177A CN 1803177 A CN1803177 A CN 1803177A CN 200510023218 CN200510023218 CN 200510023218 CN 200510023218 A CN200510023218 A CN 200510023218A CN 1803177 A CN1803177 A CN 1803177A
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Abstract
The invention relates to a traditional Chinese pharmaceutical composition for treating gout and its preparing process, wherein the composition is prepared from sharpleaf galangal fruit, corktree bark, ash bark, polyporus umbellatus, oriental water plantain rhizome, plantain herb, coralbean bark, root of bidentate achyranthes, raw material and medicinal adjuvant. The composition can be prepared into various pharmaceutically acceptable oral preparations.
Description
Technical field
The present invention relates to technical field of Chinese medicines, be specifically related to a kind of Chinese medicine composition and preparation method for the treatment of gout.
Background technology
Gout is to continue the disease that raises and cause owing to heritability or the acquired cause of disease cause purine metabolism obstacle and blood uric acid.It is one group of disease of tissue injury due to long-term purine metabolic disturbance, blood uric acid increase.Clinical characters comprise hyperuricemia, gouty acute arthritis show effect repeatedly, treat untimely, course of disease delay, slow progress, gout complication such as the hypertension that occurs together, hyperlipidemia, coronary heart disease, diabetes, renal calculus.When pathological changes is gouty nephropathy, tangible azotemia can occur, develop into renal failure uremia; pathological changes is a urinary system calculus; heart disease is become different and activated arteries and veins sclerosis and coronary heart disease, and the life of patient with gout in serious threat, so gout is the systemic disease due to the purine metabolic disturbance.
The antigout drug clinical treatment is mainly based on colchicine, nonsteroidal antiinflammatory drug, hormone, promotion urate excretion medicine (as probenecid, sulphur than ketone and benzbromarone) with suppress uric acid synthetic drug (allopurinol).Acute period of disease is mainly used colchicine, nonsteroidal antiinflammatory drug, hormone, and the slow phase is mainly used and promotes urate excretion medicine, inhibition uric acid synthetic drug.These medicines are defectiveness all in treatment, and weak curative effect, toxic and side effects are comparatively obvious, as cause heating, allergic rash stomachache, and diarrhoea, leukocyte and thrombocytopenia even hepatic and renal function injure etc., these become the bottleneck of its clinical practice.The gout that seeks treatment from Chinese medicine safe and effective medicine and preparation are a kind of trend, also meet the needs of clinical diagnosis and treatment.
Summary of the invention
The technical problem that the present invention wants to determine is according to theory of Chinese medical science, and a kind of determined curative effect is provided, the Chinese medicine composition of the treatment gout that side reaction is little.
The Chinese medicine composition of treatment gout disclosed by the invention is to be the medically acceptable various oral formulations that the active component extract that makes of raw material and pharmaceutic adjuvant are formed with Rhizoma Dioscoreae Hypoglaucae , Cortex Phellodendri, Cortex Fraxini, Rhizoma Smilacis Glabrae, Rhizoma Alismatis, Herba Plantaginis, Cortex erythrinae, Radix Achyranthis Bidentatae and Radix et Rhizoma Rhei (processed).Wherein crude drug raw material weight percentage ratio consists of: Rhizoma Dioscoreae Hypoglaucae 10-15%, Cortex Phellodendri 5-10%, Cortex Fraxini 5-10%, Rhizoma Smilacis Glabrae 15-20%, Rhizoma Alismatis 10-15%, Herba Plantaginis 15-20%, Cortex erythrinae 10-15%, Radix Achyranthis Bidentatae 10-15% and Radix et Rhizoma Rhei (processed) 2-8%.
Pharmaceutic adjuvant of the present invention is pharmaceutic adjuvant commonly used; Described oral formulations comprises tablet, granule, capsule, pill and oral liquid etc.
Another technical problem to be solved by this invention is to provide the preparation method of above-mentioned treatment gout Chinese medicine composition.Described method comprises the following steps:
1, active component extract preparation
With 6-10 times of 80-95% soak with ethanol, reflux, extract, 2-3 time is filtered with Rhizoma Dioscoreae Hypoglaucae , Cortex Phellodendri, Cortex Fraxini, Rhizoma Alismatis, Cortex erythrinae five tastes medical material, ethanol extract; Residue mixes with Rhizoma Smilacis Glabrae, Herba Plantaginis, Radix Achyranthis Bidentatae and Radix et Rhizoma Rhei (processed) four Chinese medicine material, with 10-15 times of water logging bubble, decocts then and extracts 2-3 time, filter, it is 1.06 clear paste that filtrate is concentrated into relative density, and adding ethanol is about 65% to containing the alcohol amount, left standstill 24 hours, supernatant is water extract-alcohol precipitation liquid; Merge two kinds of extracting solution, being concentrated into relative concentration is the clear paste of 1.10～1.35 (60 ℃);
2, above-mentioned clear paste and pharmaceutic adjuvant are made various oral formulations according to a conventional method.
The present invention adopts chromatography qualitative identification Rhizoma Dioscoreae Hypoglaucae , Cortex Phellodendri, Cortex Fraxini, Radix Achyranthis Bidentatae and Radix Et Rhizoma Rhei to the above-mentioned oral formulations that makes, and adopts the content of berberine hydrochloride in the high effective liquid chromatography for measuring preparation, with the quality of control preparation.
The traditional Chinese medical science think within the existing spleen of the pathogenesis of the gout fortune weakness because of, have again outside the eating and drinking without temperance because of, eventually because of accumulate in the turbid damp, damp-heat gluing each other, multiple abscess joint fall ill.Deep greasy the stagnating of the heresy of turbid damp, the internal organs of being detained, the retardance mechanism of qi causes the ascending or descending movement of vital Qi imbalance, and it is unfavorable that turbid urine is drained, the turbid stasis of blood be detained meridians, joint, strongly fragrant and heat-transformation and falling ill.From existing clinical data, gout is at most with the damp-heat accumulation type, accounts for 85%, and all the other pattern of syndrome also all are to accumulate in the turbid damp, and with the passing of time living transconversion into heat expectorant causes the stasis of blood or damages due to the cloudy liquid, so the key that turbid collateral dredging is treatment hyperuricemia and gouty arthritis is let out in removing dampness.
Prescription of the present invention is a monarch drug with Rhizoma Dioscoreae Hypoglaucae , and removing dampness is let out turbid, easing joint movement.Cortex Phellodendri is the heat of the clear part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels of ministerial drug, dampness poison, and assistant Rhizoma Smilacis Glabrae, the sharp joint of Cortex Fraxini poison dehumidifying, Rhizoma Alismatis, Herba Plantaginis, Radix et Rhizoma Rhei (processed) make damp remove from defecation, strengthen the effect of Rhizoma Dioscoreae Hypoglaucae .Use the Cortex erythrinae wind-damp dispelling, the meridian dredging, joint of the lower extremity swell and ache particularly suitable, and the analgesic therapy of Radix Achyranthis Bidentatae blood stasis dispersing and deswelling is again a guiding drug.All medicines share, rise altogether removing dampness let out turbid, heat-clearing and toxic substances removing, the merit of disperse blood stasis and dredge collateral stops hot and humid ecchymosis to change life mutually, and the pathology link is ended.Modern pharmacy studies show that, the damp and hot medicine in Qinghua contains steroidal saponin mostly, can suppress inflammatory mediator discharges, part can suppress leukocyte chemotaxis, thereby anti-inflammatory analgetic, and the removing dampness dampness removing mostly be alkalescence, but alkalized urine, improve the human internal environment, simultaneously by suppress renal tubules again absorption function stronger diuresis is arranged and accelerates the excretory effect of composition in the urine.It is reasonable that the present invention treats the Chinese medicine composition composition formula of gout, and goat colony is had the stronger specific aim and the individual suitability.
Treat the test of pesticide effectiveness that the Chinese medicine composition (pyretic arthralgia disappears) of gout is correlated with the present invention, prove that Chinese medicine composition of the present invention is from fermentation performance drug actions such as antiinflammatory, analgesia, uric acid resistings.
One, to the effect of experimental gout model
1. crystallite uric acid sodium (MSU) is caused the effect of rat paw edema
Pyretic arthralgia disappears by 1,2,4g/kg continuous irrigation stomach is after 5 days, can obviously suppress crystallite uric acid sodium (MSU) and cause rat paw edema, and the suppression ratio during its 2h is respectively 26.4,38.8 and 40%, then is 40.8% during colchicine 0.4mg/kg dosage.
2. crystallite uric acid sodium (MSU) is caused the inhibitory action of rabbit gonarthritis
Pyretic arthralgia disappears by 0.5,1,2g/kg continuous irrigation stomach is after 5 days, can suppress the development degree that crystallite uric acid sodium (MSU) causes the rabbit gonarthritis, suppression ratio to leukocyte count in its articular cavity is respectively 30.1,31.6,38.8%, then is 46.1% during colchicine 0.2mg/kg dosage.Simultaneously, the pathological section result shows, pyretic arthralgia disappears can reduce the hyperemia of knee joint synovial membrane, come off, necrosis and cell infiltration.
Two, to the effect of experimental inflammatory model
1. rat carrageenan is caused the inhibitory action of pedal swelling
Pyretic arthralgia disappears by 1,2,4g/kg continuous irrigation stomach is after 5 days, can obviously suppress carrageenin and cause rat paw edema, and the suppression ratio during its 2h is respectively 27.7,32.5 and 34%, then is 41.9% during indomethacin 0.01g/kg dosage.
2. to the inhibitory action of mice caused by dimethylbenzene xylene auricle edema
Pyretic arthralgia disappears by 1.5,3,6g/kg continuous irrigation stomach is after 5 days, can obviously suppress the mice caused by dimethylbenzene xylene auricle edema, and its suppression ratio is respectively 16.7,21.0 and 26.3%, then is 32.6% during indomethacin 0.02g/kg dosage.
Three, to causing the analgesic activity of pain model
1. Dichlorodiphenyl Acetate causes the inhibitory action of mouse writhing
Pyretic arthralgia disappears and can reduce the pain reaction of mice Dichlorodiphenyl Acetate preferably, pyretic arthralgia disappears by 1.5,3,6g/kg continuous irrigation stomach after 5 days Dichlorodiphenyl Acetate cause the suppression ratio of turning round the stoichiometric number in the body 20 minutes and be respectively 58.2,68,71%, then be 71.4% during indomethacin 0.02g/kg dosage.
2. the mice hot plate is caused the inhibitory action of pain
Pyretic arthralgia disappears, and that the mice hot plate is caused the inhibitory action of pain is relatively poor relatively, and 1.5,3, under the 6g/kg dosage, raising rate in the animal threshold of pain only is 29.6,37.9,40%, then is 106% during indomethacin 0.02g/kg dosage.
Four, to the inhibitory action of hyperuricemia
The inhibitory action of the mice hyperuricemia that hypoxanthine is caused
Pyretic arthralgia disappears by 1.5,3,6g/kg continuous irrigation stomach is after 5 days, can obviously suppress hypoxanthine and cause the mice hyperuricemia, and suppression ratio is respectively 25.4,31.5,34.9%, and positive drug probenecid 0.12g/kg then has 44.1% during dosage.
The specific embodiment
The preparation of embodiment 1 granule
Prescription:
Rhizoma Dioscoreae Hypoglaucae 300g Cortex Phellodendri 200g Cortex Fraxini 200g
Rhizoma Smilacis Glabrae 400g Rhizoma Alismatis 300g Herba Plantaginis 400g
Cortex erythrinae 300g Radix Achyranthis Bidentatae 300g Radix et Rhizoma Rhei (processed) 100g
Preparation method:
With five tastes medical materials such as Rhizoma Dioscoreae Hypoglaucae , Cortex Phellodendri, Cortex Fraxini, Rhizoma Alismatis, Cortex erythrinaes, with 8 times of amount 70% soak with ethanol reflux, extract, 2 hours after 1 hour, add 8 times of amount 70% alcohol reflux 2 hours for the second time again, merge backflow twice, filter, promptly get ethanol extract.Four Chinese medicine materials such as Rhizoma Smilacis Glabrae, Herba Plantaginis, Radix Achyranthis Bidentatae, Radix et Rhizoma Rhei (processed) were soaked in water earlier 1 hour, add ethanol again and propose the medicinal residues decoction, add 12 times of water gagings at every turn, decoct each 2 hours 3 times.Merge decocting liquid, filter, it is 1.06 clear paste that filtrate is concentrated into relative density, and adding ethanol is 65% to containing the alcohol amount, leaves standstill 24 hours, and supernatant is water extract-alcohol precipitation liquid.Merge ethanol extract and water extract-alcohol precipitation liquid, decompression recycling ethanol, and continue to be concentrated into the clear paste that relative concentration is 1.10～1.35 (60 ℃).Qinghuo reagent adds appropriate amount of auxiliary materials granulates, and drying is made 960g, packing, promptly.Weight per package 16g, hydrochloric berberine should be no less than 12mg.
Embodiment 2 preparation tablets
Prescription:
Rhizoma Dioscoreae Hypoglaucae 75g Cortex Phellodendri 52.5g Cortex Fraxini 60g
Rhizoma Smilacis Glabrae 150g Rhizoma Alismatis 112.5g Herba Plantaginis 112.5g
Cortex erythrinae 75g Radix Achyranthis Bidentatae 75g Radix et Rhizoma Rhei (processed) 37.5g
Preparation method:
Make clear paste with embodiment 1 method.Qinghuo reagent adds appropriate amount of auxiliary materials granulates, and drying is pressed into 1000, sugar coating or film-coat, promptly.Every weight 0.5g, hydrochloric berberine should be no less than 2mg.
The preparation of embodiment 3 pills
Prescription:
Rhizoma Dioscoreae Hypoglaucae 137.5g Cortex Phellodendri 112.5g Cortex Fraxini 75g
Rhizoma Smilacis Glabrae 187.5g Rhizoma Alismatis 125g Herba Plantaginis 250g
Cortex erythrinae 137.5g Radix Achyranthis Bidentatae 137.5g Radix et Rhizoma Rhei (processed) 87.5g
Preparation method:
Make clear paste by embodiment 1 method.The qinghuo reagent drying is beaten powder, and every 100g powder adds refined honey 150～180g and makes big honeyed pills, promptly.
The preparation of embodiment 4 syrups
Prescription:
Rhizoma Dioscoreae Hypoglaucae 162.5g Cortex Phellodendri 62.5g Cortex Fraxini 112.5g
Rhizoma Smilacis Glabrae 212.5g Rhizoma Alismatis 137.5g Herba Plantaginis 225g
Cortex erythrinae 162.5g Radix Achyranthis Bidentatae 150g Radix et Rhizoma Rhei (processed) 25g
Preparation method:
With five tastes medical materials such as Rhizoma Dioscoreae Hypoglaucae , Cortex Phellodendri, Cortex Fraxini, Rhizoma Alismatis, Cortex erythrinaes, with 8 times of amount 70% soak with ethanol reflux, extract, 2 hours after 1 hour, add 8 times of amount 70% alcohol reflux 2 hours for the second time again, merge backflow twice, filter, promptly get ethanol extract.Four Chinese medicine materials such as Rhizoma Smilacis Glabrae, Herba Plantaginis, Radix Achyranthis Bidentatae, Radix et Rhizoma Rhei (processed) were soaked in water earlier 1 hour, add ethanol again and propose the medicinal residues decoction, add 12 times of water gagings at every turn, decoct each 2 hours 3 times.Merge decocting liquid, filter, it is 1.06 clear paste that filtrate is concentrated into relative density, and adding ethanol is 65% to containing the alcohol amount, leaves standstill 24 hours, and supernatant is water extract-alcohol precipitation liquid.Merge ethanol extract and water extract-alcohol precipitation liquid, decompression recycling ethanol, and continue to be concentrated into an amount of; Get an amount of sucrose, add water boil, filter, merge, add an amount of antiseptic, add water to 1000ml with above-mentioned concentrated solution, mixing, packing, promptly.Every bottle of 100ml, hydrochloric berberine should be no less than 36mg.
The preparation of embodiment 5 mixture
Prescription:
Rhizoma Dioscoreae Hypoglaucae 175g Cortex Phellodendri 75g Cortex Fraxini 62.5g
Rhizoma Smilacis Glabrae 187.5g Rhizoma Alismatis 162.5g Herba Plantaginis 212.5g
Cortex erythrinae 175g Radix Achyranthis Bidentatae 162.5g Radix et Rhizoma Rhei (processed) 37.5g
Preparation method:
Medical material is soaked in water to be decocted in 1 hour, added 12 times of water gagings at every turn, decocted each 2 hours 3 times.Merge decocting liquid, filter, it is 1.06 clear paste that filtrate is concentrated into relative density, and adding ethanol is 65% to containing the alcohol amount, leaves standstill 24 hours, and supernatant is water extract-alcohol precipitation liquid.Merge ethanol extract and water extract-alcohol precipitation liquid, decompression recycling ethanol, and continue to be concentrated into an amount of; Get an amount of sucrose, add water boil, filter, merge, add an amount of antiseptic, add water to 1000ml, stir evenly with above-mentioned concentrated solution, fill, promptly.Every bottle of 100ml, hydrochloric berberine should be no less than 36mg.
The preparation of embodiment 6 capsules
Proportioning:
Rhizoma Dioscoreae Hypoglaucae 112.5g Cortex Phellodendri 60g Cortex Fraxini 52.5g
Rhizoma Smilacis Glabrae 127.5g Rhizoma Alismatis 75g Herba Plantaginis 112.5g
Cortex erythrinae 75g Radix Achyranthis Bidentatae 75g Radix et Rhizoma Rhei (processed) 60g
Preparation method:
Make clear paste by embodiment 1 method, drying is ground into fine powder, incapsulates, and makes 1000, promptly.Every weight 0.5g, hydrochloric berberine should be no less than 2mg.
Embodiment 7 berberine hydrochloride contents
The test of chromatographic condition and system suitability: with octadecyl silane is filler, and with acetonitrile: the 0.1M dipotassium hydrogen phosphate solution: 0.025M sodium dodecyl sulfate solution (50: 25: 25) is a mobile phase, and the detection wavelength is 345nm, 40 ℃ of column temperatures.Number of theoretical plate is pressed berberine hydrochloride and is calculated, and should be not less than 4000.
The preparation of reference substance solution:, precision takes by weighing at 5 hours berberine hydrochloride reference substance of 105 ℃ of dryings, adds methanol and makes the solution that every ml contains 0.1mg, promptly.
The preparation of need testing solution: get the about 0.4g of finished product that embodiment 1 makes, accurate claim surely, put in the 25ml measuring bottle, add hydrochloric acid-methanol (1: 100) 20ml, supersound process 20 minutes is put coldly, adds methanol to scale, filters, and gets subsequent filtrate, promptly.
Assay method: accurate reference substance and each 5-10 μ l of need testing solution of drawing, inject chromatograph of liquid respectively, calculate, promptly.
Hydrochloric berberine must not be less than 12mg in the every bag of this product 16g granule.
Embodiment 8 pharmacodynamics tests
One, test material
1.1 be subjected to reagent: the pyretic arthralgia granule (embodiment 1 method makes) that disappears, sea, Shanghai day pharmaceutcal corporation, Ltd; Positive control drug: colchicine, Kunming; Indomethacin, Linfen, Shanxi Qi Lin pharmaceutcal corporation, Ltd, 25mg/ sheet probenecid.When animal was irritated the stomach operation, the CMC-Na solution with 0.5% ground and is made into certain density suspension.
1.2 crystallite uric acid sodium preparation (MSU): take by weighing the 8g uric acid and put in the 1600ml boiling water, accent pH to 7.4 is heated to 95 ℃, and the room temperature cooling is also stirred gently, filters, and gets crystallite uric acid sodium, high temperature (200 ℃) sterilization.Time spent is ground the suspension that is made into 100mg/ml with physiological saline solution.
1.3 animal: SD rat, Kunming mouse, rabbit, available from Nanjing An Limo Science and Technology Ltd..
Two, experimental technique
1. pyretic arthralgia disappears to the effect of experimental gout model
1.1 disappearing, pyretic arthralgia crystallite uric acid sodium (MSU) is induced the influence of rat paw edema
The SD rat, ♂, 180 ± 20g, 50, be divided into 5 groups at random, 10 every group, be respectively blank group, colchicine (0.4mg/kg), pyretic arthralgia disappear low dosage, middle dosage and high dose group (1g/kg, 2g/kg, 4g/kg), each CMC-Na solution of medicinal 0.5% is made into suspension, gastric infusion, the administration volume is 4ml/kg, and gastric infusion is 5 days continuously, wherein the blank group is irritated stomach and is given 0.5% CMC-Na solution, and volume is identical.1h after the last administration, each treated animal all cause inflammation in the MSU of right back sufficient plantar subcutaneous injection 0.1ml (100mg/ml).Adopt the rat paw volumetric method, mensuration causes the right back sufficient sole of the foot volume-variation of scorching each time of front and back, and the difference that causes scorching front and back volume with the right back sufficient sole of the foot is the swelling degree, respectively at causing inflammation back 1h, 2h, 4h, 6h, 8h mensuration swelling degree, each organizes data and the blank group compares, and carries out the analysis of t inspection statistics.
1.2 pyretic arthralgia disappears to the influence of the inductive rabbit acute arthritis of crystallite uric acid sodium (MSU) model
The white rabbit of New Zealand, 2.5kg about, 48, ♀ ♂ half and half, be divided into 6 groups at random, every group 8, be respectively normal control group, model group, colchicine (0.2mg/kg), pyretic arthralgia disappear low dosage, middle dosage and high dose group (0.5g/kg, 1g/kg, 2g/kg), each CMC-Na solution of medicinal 0.5% is made into suspension, gastric infusion, and the administration volume is 2ml/kg, gastric infusion is 5 days continuously, every day 1 time, wherein normal control group and model group are irritated stomach and are given 0.5% CMC-Na solution, and volume is identical.0.5h after the last administration, except that the normal control group, the MSU normal saline suspension (100mg/ml) of all the other each treated animal knee joint intracavitary administration 0.3ml causes scorching back 5h and puts to death rabbit, draws the joint fluid 20 μ l in the knee joint cavity, carries out numeration of leukocyte; And the knee joint synovial membrane fixed with 10% formalin solution, carry out histological examination.
2. pyretic arthralgia disappears to the effect of inflammatory model
On Carrageenan causes the influence of rat paw edema 2.1 pyretic arthralgia disappears
The SD rat, ♂, 160 ± 20g, 50, be divided into 5 groups at random, 10 every group, be respectively blank group, indomethacin (10mg/kg), pyretic arthralgia disappear low dosage, middle dosage and high dose group (1g/kg, 2g/kg, 4g/kg), each CMC-Na solution of medicinal 0.5% is made into suspension, gastric infusion, and the administration volume is 4ml/kg, gastric infusion is 5 days continuously, every day 1 time, wherein the blank group is irritated stomach and is given 0.5% CMC-Na solution, and volume is identical.0.5h after the last administration, each treated animal all cause inflammation in 1% the chondrus ocellatus Holmes glue of right back sufficient plantar subcutaneous injection 0.1ml.Adopt the rat paw volumetric method, mensuration causes the right back sufficient sole of the foot volume-variation of scorching each time of front and back, and the difference that causes scorching front and back volume with the right back sufficient sole of the foot is the swelling degree, respectively at causing inflammation back 1h, 2h, 4h, 6h, 8h mensuration swelling degree, each organizes data and the blank group compares, and carries out the analysis of t inspection statistics.
Xylol causes the influence of mice auricle swelling 2.2 pyretic arthralgia disappears
Kunming mouse, ♂, 28 ± 2g, 50, be divided into 5 groups at random, 10 every group, be respectively blank group, indomethacin (20mg/kg), pyretic arthralgia disappear low dosage, middle dosage and high dose group (1.5g/kg, 3.0g/kg, 6.0g/kg), each CMC-Na solution of medicinal 0.5% is made into suspension, gastric infusion, and the administration volume is 10ml/kg, gastric infusion is 5 days continuously, every day 1 time, wherein the blank group is irritated stomach and is given 0.5% CMC-Na solution, and volume is identical.1h after the last administration, each auris dextra tow sides dropping xylene solution 30 μ l that organize mice causes inflammation.Take off cervical vertebra behind the 2h and put to death each mice, lay the garden auricle with the card punch of diameter 7mm respectively at its same position of left and right sides ear, weigh, calculate the weight difference of two ears, be the swelling degree, each administration group and blank group compare.
3. disappear analgesic activity research of pyretic arthralgia
The influence of writhing response that mice acetic acid is caused 3.1 pyretic arthralgia disappears
Kunming mouse, ♀ ♂ half and half, 18-21g, 50, be divided into 5 groups at random, 10 every group, be respectively blank group, indomethacin (20mg/kg), pyretic arthralgia disappear low dosage, middle dosage and high dose group (1.5g/kg, 3.0g/kg, 6g/kg), each CMC-Na solution of medicinal 0.5% is made into suspension, gastric infusion, and the administration volume is 10ml/kg, gastric infusion is 5 days continuously, every day 1 time, wherein the blank group is irritated stomach and is given 0.5% CMC-Na solution, and volume is identical.1h after the last administration, the acetic acid 0.1ml/10g of the equal ip of each treated animal injection 0.6% observes mouse writhing number of times in back 20 minutes of injection, carries out the analysis of t inspection statistics by administration group and blank group.
3.2 the influence that pyretic arthralgia disappears the mice hot plate method is stimulated bitterly
Kunming mouse, ♀, 18-21g, at first on 55 ± 0.5 ℃ hot plate, screen the mice that is reflected at bitterly between the 5-30s, get 50 of qualified mices, be divided into 5 groups at random, 10 every group, be respectively the blank group, indomethacin (20mg/kg), the pyretic arthralgia low dosage that disappears, middle dosage and high dose group (1.5g/kg, 3.0g/kg, 6.0g/kg), after the incubation period that pain is reacted before recording administration, each medicine animal carries out gastric infusion, wherein administration group is made into the suspension of respective concentration with 0.5% CMC-Na solution, carries out gastric infusion, and the administration volume is 10ml/kg, the blank group is irritated stomach and is given 0.5% CMC-Na solution, and volume is identical.Survey respectively its pain response latency when 0.5h, 1h, 2h, 4h and 6h after administration, result and blank group compare.
4. pyretic arthralgia disappears and hypoxanthine is caused the influence of mice hyperuricemia
Kunming mouse, ♀ ♂ half and half, 18-21g, 60, be divided into 6 groups at random, every group 10, be respectively normal control group, model group, probenecid (120mg/kg), pyretic arthralgia disappear low dosage, middle dosage and high dose group (1.5g/kg, 3.0g/kg, 6.0g/kg), each CMC-Na solution of medicinal 0.5% is made into suspension, gastric infusion, and the administration volume is 10ml/kg, gastric infusion is 5 days continuously, every day 1 time, wherein normal control group and model group are irritated stomach and are given 0.5% CMC-Na solution, and volume is identical.1h after the last administration, except that the normal control group, the equal ip injection of all the other each treated animals hypoxanthine 600mg/kg, in each rathole socket of the eye blood sampling of injection back 3h, with uric acid content in the testing uric acid kit measurement serum, administration group result and blank group compare.
Three, experimental result
1. pyretic arthralgia disappears to the effect of experimental gout model
From experimental result as seen: the pyretic arthralgia rat paw edema that crystallite uric acid sodium (MSU) is caused that disappears has certain inhibitory action; The rabbit acute arthritis that crystallite uric acid sodium is caused also has certain inhibitory action, and the leukocyte count of joint intraluminal fluid is obviously reduced; The tissue slice analysis finds, pyretic arthralgia disappears that granule can reduce knee joint synovial membrane hyperemia that rabbit causes because of injection MSU, comes off, necrosis and cell infiltration.
Table 1. pyretic arthralgia disappears and MSU is induced influence (n=10, the x ± s) of rat paw edema
| Group | Dosage (g/kg) | The swelling degree of the paw of different time points (%) after the administration | ||||
| 1h | 2h | 4h | 6h | 8h | ||
| Blank group colchicine group pyretic arthralgia disappears | - 0.0004 1 2 4 | 14.2±3.2 8.2±2.0 ** 11.9±2.0 * 10.0±2.3 ** 9.9±2.5 ** | 20.1±3.0 11.9±2.1 ** 14.8±2.1 ** 12.3±2.3 ** 12.1±2.7 ** | 25.2±3.5 14.6±2.2 ** 17.2±3.1 ** 15.3±2.8 ** 15.6±2.8 ** | 26.9±3.7 16.1±2.5 ** 20.0±3.2 ** 17.0±2.9 ** 17.1±3.1 ** | 27.7±4.7 19.4±2.0 ** 23.0±4.0 * 22.0±3.5 ** 20.9±3.1 ** |
Annotate:
*P＜0.05,
*Compare with the blank group p＜0.01
Table 2. pyretic arthralgia disappears to the influence of leukocyte count in the inductive rabbit arthritis of the MSU synovial membrane liquid (n=8, x ± s)
| Group | Dosage (g/kg) | Leukocyte count (* 10 in the synovial membrane liquid 9/L) |
| Normal control group model group colchicine group pyretic arthralgia disappears | - - 0.0002 0.5 1 2 | - 20.6±2.0 11.1±1.5 ** 14.7±1.5 ** 14.1±1.4 ** 12.6±1.4 ** |
Annotate:
*Compare with the blank group p＜0.01
2. pyretic arthralgia disappears to the effect of inflammatory model
From the result as seen, pyretic arthralgia disappears and can obviously suppress the rat paw edema process that carrageenin causes; The mice auricle swelling that xylol causes also has the obvious suppression effect.
The table 3. pyretic arthralgia on Carrageenan that disappears causes influence (n=10, the x ± s) of rat paw edema
| Group | Dosage (g/kg) | The swelling degree of the paw of different time points (%) after the administration | ||||
| 1h | 2h | 4h | 6h | 8h | ||
| Blank group indomethacin group pyretic arthralgia disappears | - 0.01 1 2 4 | 13.8±1.9 8.7±2.2 ** 10.8±2.0 ** 10.1±1.9 ** 9.7±1.6 ** | 19.1±2.1 11.1±1.9 ** 13.8±2.0 ** 12.9±2.0 ** 12.6±1.1 ** | 24.4±2.3 14.7±2.2 ** 17.3±2.2 ** 16.5±2.2 ** 16.0±1.6 ** | 29.1±3.0 19.2±3.2 ** 21.3±3.1 ** 20.8±2.7 ** 20.6±2.6 ** | 24.6±3.3 15.0±3.8 ** 17.3±2.9 ** 16.8±3.1 ** 16.0±2.7 ** |
Annotate:
*P＜0.05,
*Compare with the blank group p＜0.01
The table 4. pyretic arthralgia xylol that disappears causes influence (n=10, the x ± s) of mice auricle swelling
| Group | Dosage (g/kg) | Auricle edema rate (%) | Inhibitory rate of intumesce (%) |
| Blank group indomethacin group pyretic arthralgia disappears | - 0.02 1.5 3.0 6.0 | 35.3±5.3 23.8±4.1 ** 29.4±4.7 * 27.9±3.6 ** 26.0±4.3 ** | 32.6 16.7 21.0 26.3 |
Annotate:
*P＜0.05,
*Compare with the blank group p＜0.01
3. disappear analgesic activity research of pyretic arthralgia
Pyretic arthralgia disappears and can obviously reduce the mouse writhing reaction times that ip acetic acid causes, but it is not remarkable that hot plate method is caused analgesic effect bitterly.
Table 5. pyretic arthralgia disappear influence (n=10, the x ± s) of writhing response that mice acetic acid is caused
| Group | Dosage (g/kg) | Turn round the body number in 20 minutes |
| Blank group indomethacin group pyretic arthralgia disappears | - 0.02 1.5 3.0 6.0 | 29.4±10.4 8.4±4.0 ** 12.3±5.7 ** 9.4±3.9 ** 8.5±3.7 ** |
Annotate:
*Compare with the blank group p＜0.01
Table 6. pyretic arthralgia disappear influence that the mice hot plate method is stimulated bitterly (n=10, x ± s)
| Group | Dosage (mg/k g) | The pain response latency (s) before the administration | The pain response latency (s) of different time points after the administration | ||||
| 0.5h | 1h | 2h | 4h | 6h | |||
| Blank group indomethacin group pyretic arthralgia disappears | - 0.02 1.5 3.0 6.0 | 18.5±4.1 17.8±5.0 18.8±3.7 17.9±4.4 18.3±4.6 | 17.3±3.6 28.0±8.8 ** 19.8±4.0 20.2±4.2 20.0±3.3 | 15.9±3.5 35.9±7.9 ** 18.9±1.8 * 19.2±2.6 * 20.2±3.2 ** | 16.9±3.8 34.8±5.8 ** 21.9±2.1 ** 23.3±4.2 ** 23.6±5.5 ** | 18.5±4.1 35.3±6.0 ** 22.5±5.1 24.3±6.0 * 24.5±5.5 * | 21.4±4.7 27.9±5.2 ** 22.2±4.7 23.7±4.2 23.5±3.7 |
Annotate:
*P＜0.05,
*Compare with the blank group p＜0.01
4. pyretic arthralgia disappears and hypoxanthine is caused the influence of mice hyperuricemia
Find out from the result: the pyretic arthralgia mice hyperuricemia that hypoxanthine is caused that disappears has certain reduction effect, illustrates that the gout effect that pyretic arthralgia disappears may or promote that its Excretion is relevant with its inhibition uric acid.
Table 7. pyretic arthralgia disappears and hypoxanthine is caused influence (n=10, the x ± s) of mice hyperuricemia
| Group | Dosage (g/kg) | Uric acid (μ mol/L) |
| Normal control group model group probenecid group pyretic arthralgia disappears | - - 0.12 1.5 3.0 6.0 | 171.9±19.7 989.3±90.9 553.5±117.8 ** 738.5±124.5 ** 677.9±74.6 ** 644.1±77.7 ** |
Annotate:
*Compare with the blank group p＜0.01
Four, discuss
This test is adopted two kinds of experimental gouty arthritis models, multiple inflammation and is caused the pain reaction model, and the pyretic arthralgia particulate gout drug effect that disappears has been carried out comparatively systematic research.The result of the test proof pyretic arthralgia granule that disappears all has better action to above-mentioned model, wherein to the swollen and rabbit acute arthritis model of the inductive rat foot of injection uric acid sodium, show as and obviously alleviate the swelling degree, reduce numeration of leukocyte in the joint fluid, improve pathological changes, the protection synovial membrane of synovial tissue; Various inflammation and cause the pain animal obviously in, the pyretic arthralgia particle performance that disappears goes out pharmacological action preferably, and finds that it can reduce the uric acid level of the mice of hyperuricemia, these are it and treat gout clinically favourable experimental basis is provided.
Claims (3)
1, a kind of Chinese medicine composition for the treatment of gout is characterized in that active component extract and pharmaceutic adjuvant that said composition is made by the following weight ratio raw material form: Rhizoma Dioscoreae Hypoglaucae 10-15%, Cortex Phellodendri 5-10%, Cortex Fraxini 5-10%, Rhizoma Smilacis Glabrae 15-20%, Rhizoma Alismatis 10-15%, Herba Plantaginis 15-20%, Cortex erythrinae 10-15%, Radix Achyranthis Bidentatae 10-15% and Radix et Rhizoma Rhei (processed) 2-8%.
2, a kind of method for preparing the Chinese medicine composition of the described treatment gout of claim 1 is characterized in that this method comprises the following steps:
With 6-10 times of 80-95% soak with ethanol, reflux, extract, 2-3 time is filtered with Rhizoma Dioscoreae Hypoglaucae , Cortex Phellodendri, Cortex Fraxini, Rhizoma Alismatis, Cortex erythrinae five tastes medical material, ethanol extract; Residue mixes with Rhizoma Smilacis Glabrae, Herba Plantaginis, Radix Achyranthis Bidentatae and Radix et Rhizoma Rhei (processed) four Chinese medicine material, with 10-15 times of water logging bubble, decocts then and extracts 2-3 time, filter, it is 1.06 clear paste that filtrate is concentrated into relative density, and adding ethanol is about 65% to containing the alcohol amount, left standstill 24 hours, supernatant is water extract-alcohol precipitation liquid; Merge two kinds of extracting solution, being concentrated into relative concentration is the clear paste of 1.10～1.35 (60 ℃);
Above-mentioned clear paste and pharmaceutic adjuvant are made various oral formulations according to a conventional method.
3, the application of the described Chinese medicine composition of claim 1 in preparation treatment gout medicine.
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| CN101380414B (en) * | 2007-09-06 | 2012-01-25 | 中山大学附属第一医院 | Traditional Chinese medicine composition for treating gout and hyperuricemia and preparation method thereof |
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