CN101850063A - Medicinal preparation for preventing and treating gout and preparation method - Google Patents

Abstract

The invention discloses a medicinal preparation for preventing and treating gout and a preparation method thereof. The medicinal preparation is mainly prepared by using plantain seed, glabrous greenbrier rhizome, earthworm, Japanese honeysuckle stem, clematis root, radix stephaniae tetrandrae and Indian iphigenia bulb as the raw medicinal materials. A formula provided by the invention can be prepared into an oral preparation according to a conventional preparation process. The medicinal preparation has effects of clearing away heat, removing dampness, dispersing pathogenic wind, dissipating stagnation, smoothing the veins and relieving pain, has good curative effect on symptoms of redness and swelling of joints, thermalgia, unfavorable extension and the like of the gout due to accumulated dampness and heat, is safe to use, has no toxic or side effects and is novel traditional Chinese medicine for preventing and treating the gout, which is safe and efficient and has controllable quality.

Description

A kind of pharmaceutical preparation that prevents and treats gout and preparation method thereof

Technical field

The present invention relates to a kind of pharmaceutical preparation that prevents and treats gout and preparation method thereof, belong to technical field of Chinese medicines.

Background technology

Gout is-kind of ancient disease, also is a kind of frequently-occurring disease in recent years, and is closely related with the raising of people's living standard.Sickness rate is the gesture of rising year by year, and goat is that two factors of the diet environment day after tomorrow that reach of congenital heredity gene (body constitution) cause jointly.Show according to World Health Organization's updated statistics, there is patient with gout nearly 500,000,000 every year in the whole world, only China just reaches 4,000 ten thousand, just there is one family to be subjected to the torment of goat in per 40 families of China, in today of international medical science fast development, the Chinese traditional Chinese medical science is based on Traditional Chinese medical theory, in conjunction with modern medicine, the utilization modern means of science and technology are being brought into play impayable huge effect controlling in the goat field.Along with our country is prosperous and powerful day by day, the raising of people's living standard and the quickening of rhythm of life, numerous and bad life style relevant disease, rapidly increase just with surprising rapidity as diabetes, obesity, gout etc., especially gout, be considered to for a long time in the past belong to low morbidity in China, 58 examples are just reported in the whole nation altogether before 1958.But the geographic epidemiological survey in Shanghai showed in 1998, and the prevalence of local gout is up to 3.4%, and near the sickness rate of the U.S., the prompting gout has become one of commonly encountered diseases of China at present.Gout also has a lot of new knowledges in recent years to the significant damage of health, find this disease except that can causing serious arthralgia, deformity, dysfunction and kidney damage also often with or illness such as concurrent diabetes, coronary heart disease, hypertension, obesity, blood fat disorder, can cause higher deadly disability rate, so gout prevention is very urgent.

Up to the present, gout does not still have the method for radical cure, many clinically with steroidal anti-inflammatory drugs, glucocorticoid, allopurinol, colchicine etc., this quasi drugs is alleviating pain rapidly, but also cure the symptoms, not the disease, this quasi drugs toxic and side effects is bigger simultaneously, takes for a long time, and human gastrointestinal tract, hepatic and renal function are had detrimental effect.In order to develop the Chinese medicine that can safely, effectively prevent the treatment goat, the applicant has carried out a large amount of explorations and research.

Summary of the invention

Technical problem to be solved by this invention is to provide safe and effective pharmaceutical preparation that prevents and treats gout of a kind of energy and preparation method thereof, thereby overcomes the deficiencies in the prior art.

In order to solve the problems of the technologies described above, the present invention adopts following technical scheme: prevent and treat the pharmaceutical preparation of gout.Said preparation mainly is to be prepared from by following raw materials by weight percent medical material: Semen Plantaginis 10%～33%, Rhizoma Smilacis Glabrae 12%～16%, Pheretima 12%～16%, Caulis Lonicerae 12%～16%, Radix Clematidis 12%～16%, Radix Stephaniae Tetrandrae 12%～16%, Pseudobulbus Cremastrae Seu Pleiones 7%～10%.

In the above-mentioned pharmaceutical preparation that prevents and treats gout, the preferred percentage by weight of each raw material is: Semen Plantaginis 21.1%, Rhizoma Smilacis Glabrae 14.1%, Pheretima 14.1%, Caulis Lonicerae 14.1%, Radix Clematidis 14.1%, Radix Stephaniae Tetrandrae 14.1%, Pseudobulbus Cremastrae Seu Pleiones 8.4%.

The aforesaid pharmaceutical preparation that prevents and treats gout is preparation like this: take by weighing Semen Plantaginis, Rhizoma Smilacis Glabrae, Pheretima, Caulis Lonicerae, Radix Clematidis, Radix Stephaniae Tetrandrae, Pseudobulbus Cremastrae Seu Pleiones seven flavor medicine material by recipe quantity, 6～12 times of decoctings that add the total amount of writing out a prescription boil 1～3 time, the each decoction 1～3 hour, filter, the survey relative density was 1.20～1.40 extractum when filtrate was concentrated into 20～60 ℃, and preparation process is made common clinically pharmaceutical preparation routinely then.

In the preparation method of the above-mentioned pharmaceutical preparation that prevents and treats gout, described pharmaceutical preparation can be prepared into oral formulations or external preparation.

In the preparation method of the aforesaid pharmaceutical preparation that prevents and treats gout, described oral formulations comprises decoction, granule, powder, oral liquid, syrup, soft extract, pill, tablet, hard capsule, soft capsule or drop pill etc.

Prescription medicine characteristic of the present invention: Semen Plantaginis, have another name called Herba Plantaginis reality, Rana limnocharis clothing, pig ear tassel, phoenix eyes Semen Plantaginis, be the dry mature seed of PlantagoasiaticaL. before the Plantaginaceae plant or Plantago depressa Willd PlantagodepressaWilld..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.Rhizoma Smilacis Glabrae: be the dry rhizome of liliaceous plant smilacis glabra SmilaxglabraRoxb..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, muscles and bones contracture pain, scrofula, skin infection.Pheretima: be the dry body of Annelida hard iron the earthworm animal Pheretima aspergillum Pheretimaaspergilum of section (EPerrier), popular Pheretimatschiliensis PvulgarisChen, William Pheretimatschiliensis Pguillelmi (Michaelsen) or comb the region between the heart and the diaphragm hair earthworm PpectiniferaMichaelsen.Salty-cold.Heat clearing away, spasmolytic, diuresis, detoxifcation.Calentura mania and irritation, infantile convulsion, cough with asthma, headache conjunctival congestion, laryngopharynx swelling and pain, urinary obstruction, Fengshi Guanjie pain, diseases such as hemiplegia.Caulis Lonicerae: the dry stem branch of caprifoliaceae plant Radix Ophiopogonis LonicerajaponicaThunb..Sweet, cold.Attach to the lung and stomach meridians.Heat-clearing and toxic substances removing, the dispelling wind collateral dredging.Be used for the epidemic febrile disease heating, toxic-heat and blood stasis, carbuncle skin infection, rheumatism pyretic arthralgia, redness and swelling of joints burning pain.Radix Clematidis: be the dry root and rhizome of dicotyledon Ranunculaceae Ranunculaceae Radix Clematidis ClematischinensisOsbeck, Clematis hexapetala (mountain knotweed) C.hexapetalaPall. or northeast clematis (black common vetch) C.manshuricaRupr..Hot salty, temperature.Go into urinary bladder channel.Expelling wind and removing dampness, removing obstruction in the collateral to relieve pain, expectorant water, the hypochondriac lump of loosing.Cure mainly gout insensitive impediment, rheumatic arthralgia, numb limbs and tense tendons, chills and pain of the waist and kness, the contracture of muscle arteries and veins, joint stuffiness, beriberi, malaria, lump in the abdomen.Radix Stephaniae Tetrandrae: the dry root of menispermaceous plants Radix stephaniae tetrandrae StephaniatetrandraS.Moore.Hardship, cold.Return bladder, lung meridian.Inducing diuresis to remove edema, wind-expelling pain-stopping.Be used for the edema beriberi, dysuria, eczema sore, rheumatic arthralgia; Hypertension.Pseudobulbus Cremastrae Seu Pleiones: English by name PSEUDOBULBUSCREMASTRAESEUPLEIONES phonetic name Qiannianjian is orchid Cremastra appendiculata Cremastraappendiculata(D.Don) Makino, pleione bulbocodioides Pleionebulbocodioides(Franch.) the dry pseudobulb of Rolfe or Yunnan pleione bulbocodioides PleioneyunnanensisRolfe.Sweet, little suffering, cold.Return liver, spleen channel.Heat-clearing and toxic substances removing, dissipating phlegm and resolving masses.Be used for the carbuncle furunculosis, scrofula sucutaneous nodule, tuberculous lymphadenitis, snake bite and insect sting.

Side of the present invention separates: the traditional Chinese medical science is thought the generation of gout can be divided into two aspects of exopathogenic factor and endogenous cause of ill.Exopathogenic factor has wind, cold, wet, hot heresy to attack human body, numbness resistance meridians.Interior because healthy energy deficiency or overstrain.The main pathogenesis of primary disease is exopathogen retardance meridians, QI-blood circulation is not smooth, so that joint, myalgia, numbness, weighing, joint stuffiness and form arthromyodynia, because the different in kind of being invaded by exogenous pathogen, or inclined to one side victory is arranged, and clinical manifestation is also different, and the inclined to one side victor of ailment said due to cold or exposure is a migratory arthralgia, ailment said due to cold or exposure benefaction and number becomes is so the arthralgia migration is indefinite; The inclined to one side victor of cold-evil is an arthralgia aggravated by cold, cold main spasm, and its property stagnates, so arthralgia has the location; The inclined to one side victor of damp is a damp arthralgia, and is moist heavy sticky, so the articular muscle numbness is weighing swelling; Heat victor partially is pyretic arthralgia, the meridians accumulation of heat, so see that redness and swelling of joints is scorching hot, pain can not be near.Arthromyodynia is from the beginning of true card, vital QI being weakened and pathogen being violent then for a long time, and deficiency and excess is held under the arm assorted.The principle of Chinese traditional treatment gout is to be method with clearing away heat-damp and promoting diuresis, promoting blood circulation to remove obstruction in the collateral, and contained some biotic components in the Chinese medicine promote the drainage of uric acid in addition.Acute stage is dialectical to be retention of damp-heat in the interior, and controlling clearing away heat-damp and promoting diuresis to be main; Catabasis is dialectical to be obstruction of collaterals by blood stasis, and controlling promoting blood circulation to remove obstruction in the collateral to be main.

We cure mainly due to the damp-heat accumulation gout and see redness and swelling of joints, burning pain, diseases such as joint stuffiness, in the side based on the Semen Plantaginis clearing away heat-damp and promoting diuresis; With Rhizoma Smilacis Glabrae dehumidifying, easing joint movement; With Pheretima heat clearing away, spasmolytic, diuresis; With the Caulis Lonicerae heat-clearing and toxic substances removing, the dispelling wind collateral dredging; With the Radix Clematidis expelling wind and removing dampness, removing obstruction in the collateral to relieve pain, expectorant water, the hypochondriac lump of loosing; With Radix Stephaniae Tetrandrae inducing diuresis to remove edema, wind-expelling pain-stopping; With Pseudobulbus Cremastrae Seu Pleiones heat-clearing and toxic substances removing, dissipating phlegm and resolving masses; All medicines share, and receive clearing away heat-damp and promoting diuresis altogether, dispelling wind-evil and transforming calculus, the merit of removing obstruction in the collateral to relieve pain.

Function of the present invention cures mainly: medicine of the present invention has clearing away heat-damp and promoting diuresis, dispelling wind-evil and transforming calculus, the effect of removing obstruction in the collateral to relieve pain.Be mainly used in due to the damp-heat accumulation gout and see redness and swelling of joints, burning pain, diseases such as joint stuffiness.

In order to verify that medicine of the present invention has excellent curative, the applicant has carried out series of experimental research, and is specific as follows:

One, preliminary pharmacodynamics test research

Rat acute gout model due to the employing uric acid sodium has been observed the arthritic pharmacological action of gout of the present invention No. 1 control acute gout, now its experimental result is reported as follows.

1, test material

1.1 animal: the SD rat, male, body weight (230 ± 10g), the quality certification number: the SCXK(Chongqing) 2002003.

1.2 medicine and reagent

Be subjected to reagent: No. 1, gout, pharmaceutical preparation of the present invention.Lot number: do not have; Specification: the 240g/ bag, character: black powder, face with preceding and be made into suspension with distilled water.Uric acid sodium: U.S. SIGMA-ALDRICH company, lot number: 214-838-1.Face the time spent and get uric acid sodium 1g, add normal saline 10ml dissolving, with standby after the degerming of 0.22um filtering with microporous membrane.Colchicine is Xishuangbanna pharmaceutcal corporation, Ltd product, specification: 0.5mg/ sheet, lot number: the accurate word H53021369 of traditional Chinese medicines.

1.3 key instrument:BS110S precise electronic balance (Beijing Sai Duolisi joint-stock company), timer (the Kweiyang perseverance is because of biotech firm), KDC-2044 low speed refrigerated centrifuge (going up Hai'an booth centrifuge factory), Au-2700 fully-automatic analyzer (Olympus company).

2, experimental technique

2. 1 gout animal model manufacture methodPress methods such as Coderre, promptly insert tibia tendon inboard from 45 ° of directions, 0.2mL uric acid sodium solution is injected into the ankle joint chamber, cause rat gout model with No. 6 entry needles ankle joint dorsal part in right side after being tried rat.

2.2 modeling and grouping administration90 of SD cleaning level rats, male, adaptability fed for 1 week, was divided into 9 groups at random: i.e. blank group, model control group, colchicine group, No. 1 low dose group of gout, middle dosage group, high dose group, irritate stomach dosage by the conversion of people Mus body surface area.1 group of gout gives 0.75g/kg, 1.5g/kg, 3.0g/kg respectively by basic, normal, high dosage, and the autumn, scorching celestial alkali group was 0.5g/kg, gastric infusion, every day 1 time, 7d continuously.Capacity normal saline such as matched group are irritated stomach, and each organizes 1h modeling after 3d irritates stomach the 1st time.The right ankle joint intracavitary administration of normal control group 0.2mL normal saline, all the other each group injection 0.2ml uric acid sodium solutions.

2.3 observation index

2.3.1 tried the footpath variation of joint weekEach organize rat respectively before modeling and after the modeling back 6h, 12h, 24h, 48h tried the ankle joint same area respectively, measure its footpath with nonelastic tape in week, each organizes the variation that is tried joint Zhou Jing before and after observing the treatment of modeling rat.

2.3.2 gait changesPress the method that Coderre introduces, observe the gait of respectively organizing rat respectively at 3h, 6h, 24h, 48h different time and change after modeling, classified estimation is subjected to the influence of reagent thing to the animal gait.Rank scores standard: 0 grade: normal walking, 0 minute; The I level: the slight limping, it is slightly crooked to be tried lower limb, 1 minute; The II level: moderate is walked lamely, and is tried lower limb and has just touched ground, 2 minutes; The III level: the severe limping is tried lower limb and has just been touched ground, the 3 sufficient walkings that land, 3 minutes.

2.3.3 arthral fluid numeration of leukocyteAfter the molding the 4th day, 1h after time administration, with 10% chloral hydrate with rat anesthesia after, extract and respectively organize the rat arthroedema, carry out numeration of leukocyte under the smear, light microscopic.

2.3.4 soft tissue of joint morphological examinationAfter molding and the administration the 3rd day, with 10% chloral hydrate with rat anesthesia after, cut joint tissue, with 4% formaldehyde fixed after 48 hours, paraffin embedding, conventional section 4um, HE dyeing, observe the synovial membrane blood vessel and enlarge a hyperemia, edema, pathological changes such as cell infiltration degree.

2.4 statistical proceduresEach organizes data with mean plus-minus mark; The difference expression (

S); Judge the significance of group difference with the t check.

3, result

3.1 relatively to the scoring of different time gaitThe result shows, the model group integration obviously raises, dosage group 12 hours integrations after molding reduce than model group in No. 1, the positive drug group, gout, No. 1 middle and high dosage group of gout obviously reduces (p＜0.05) in 12h, 24h, No. 1 low dose group of gout, No. 1 high and low amount group of gout does not have obvious reduction to rat gait integration, sees Table 1.

The table 1 pair not comparison of phase gait scoring simultaneously (

S divides)

Compare * p＜0.05 with model group

3.2 influence to joint Zhou Jing before and after the modelingThe result shows, compare with blank, obviously increase (p＜0.05) of joint week footpath before and after the model group modeling, in No. 1, the positive drug group, gout dosage after modeling when 3h, 6h, 24h, 48h mutually in all visible joint Zhou Jing (swelling degree) obviously alleviate than model group, but No. 1 low amount group of gout to joint week the footpath do not have obviously influence.Results suggest, No. 1 1.5g/kg of gout of the present invention can alleviate arthroncus, the results are shown in Table 2.

Table 2 pair associated section week footpath comparison simultaneously ( S, Cm)

Compare * p＜0.05 with the blank group; Compare #*p＜0.05 with model group

3.3 influence to the joint fluid numeration of leukocyteThe result shows that the WBC number obviously increases in the model group joint fluid.Compare with model group, colchicine 0.5g/kg, gout No. 1 1.5g/kg, 3.0g/kg all can reduce WBC seepage discharge in the joint fluid (p＜0.05), the results are shown in Table 3.

The comparison of table 3 joint fluid WBC counting (

S, * 10 ^9.L ^-1)

Compare * p＜0.05 with model group

3.4 influence to synovium of joint pathologyHE dyeing, light microscopic is observed down, and the sliding organizational structure in normal control group joint is normally clear, does not see obvious cell infiltration; The visible synovium of joint blood vessel of model group enlarges opens hyperemia, interstitial edema, and inflammatory cell infiltration companion cellulose oozes out; Compare with model group, No. 1 low, middle dosage group of gout sees that blood vessel expands blood, a little cell infiltration, and the surface sees that cellulose oozes out; The congestion of blood vessel that No. 1 high dose group of gout is slight expansion, cell infiltration is not obvious, and water breakthrough is not swollen; The colchicine group is seen the expansion of part blood vessel mild hyperaemia, and cell infiltration is not obvious.

4, conclusion

4.1 gout No. 1 1.5g/kg, 3.0g/kg can obviously improve the effect that causes scorching rat gait at 12h, 24h.

4.2 No. 1 1.5g/kg of gout all can alleviate the arthroncus degree at 3h, 6h, 24h, 48h.

4.3 gout No. 1 3.0g/kg, 1.5g/kg all can reduce WBC seepage discharge in the joint fluid.

4.4 the joint tissue morphological examination, No. 1 3.0g/kg group of gout compares with model group, can alleviate congestion of blood vessel expansion, reduces cell infiltration.Results suggest, gout can be improved the joint tissue pathology damage No. 1.

Two, Study on Preparation

1, preparation technology

1.1 prescription:Semen Plantaginis 450g, Rhizoma Smilacis Glabrae 300g, Pheretima 300g, Caulis Lonicerae 300g, Radix Clematidis 300g, Radix Stephaniae Tetrandrae 300g, Pseudobulbus Cremastrae Seu Pleiones 180g.

1.2 method for making:Get the seven flavor medicine material, 10 times of decoctings that add the total amount of writing out a prescription boil 2 times, decoct 3 hours at every turn, filter, and it is 1.25(60 ℃ that filtrate is concentrated into relative density) extractum, add right amount of auxiliary materials, granulate, drying, fill is made 1000, promptly.

2, Study on Preparation

2.1 process route is determinedThis product prescription is made up of Semen Plantaginis, Rhizoma Smilacis Glabrae, Pheretima, Caulis Lonicerae, Radix Clematidis, Radix Stephaniae Tetrandrae, Pseudobulbus Cremastrae Seu Pleiones 7 flavor medicines, takes to fry in shallow oil soup.The character of determining on the basis of respecting the clinical usage of former prescription, to take into full account each medical material in the prescription of process route.The character of each medical material is as follows in this project prescription:

(1) Semen Plantaginis This product is sweet, is slightly cold.Return liver, kidney, lung, small intestine meridian.The tool 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.This product contains galacturonic acid, volume phlegmatic temperament, aucubin, and contains plantenolic acid, choline, adenine, succinic acid, resin etc.

(2) Rhizoma Smilacis Glabrae This product is sweet, light, and is flat.Return liver, stomach warp.Has 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, muscles and bones contracture pain, scrofula, skin infection.This product mainly contains the smilax saponin class, still contains chemical constituents such as tigogenin, tannin.

(3) Pheretima This product nature and flavor are salty, cold, go into liver, spleen, lung, urinary bladder channel, the merit that clearing heat for calming endogenous wind, clearing lung, relieving asthma, dredge the meridian passage, clearing away heat and promoting diuresis are arranged is applicable to high fever convulsions, tic, lung-heat cough with asthma, rheumatism pyretic arthralgia, joint congestion and swelling pain, that song is stretched is unfavorable, accumulation of heat in the urinary bladder, dysuria etc.This product main component be ground LONGSU, lumbrofebrin, chemical constituents such as abortin, xanthine, choline, cholesterol, fatty acid, lipids, nucleic acid derivative, several amino acids, vitamins and inorganic salt.

(4) Caulis Lonicerae this product is sweet, and is cold.Attach to the lung and stomach meridians.Has heat-clearing and toxic substances removing, the dispelling wind collateral dredging.Be used for the epidemic febrile disease heating, toxic-heat and blood stasis, carbuncle skin infection, rheumatism pyretic arthralgia, redness and swelling of joints burning pain.Main leaf contains flavonoids such as lonicerin, luteolin.Stem contains tannin, alkaloid etc.

(5) Radix Clematidis This product suffering is salty, and temperature is poisonous.Has expelling wind and removing dampness, removing obstruction in the collateral to relieve pain, expectorant water, the hypochondriac lump of loosing.Be used for gout insensitive impediment, rheumatic arthralgia, numb limbs and tense tendons, chills and pain of the waist and kness, the contracture of muscle arteries and veins, joint stuffiness, beriberi, malaria, lump in the abdomen, tetanus, tonsillitis, all a fishbone or other bone caught in the throat pharynxs.。This product root contains protoanemonin and is the Saponin etc. of glycoside unit with hederagenin, table hederagenin and oleanolic acid.

(6) Radix Stephaniae Tetrandrae This product hardship, cold.Return bladder, lung meridian.。Has inducing diuresis to remove edema, wind-expelling pain-stopping.Be used for the edema beriberi, dysuria, eczema sore, rheumatic arthralgia; Hypertension.This product contains multiple alkaloid, wherein is mainly tetrandrine, demethyltetrandrine, Cyclea racemosa Oliv. quaternary ammonium base etc.

(7) sweet, the little suffering of Pseudobulbus Cremastrae Seu Pleiones this product, cold.Return liver, spleen channel.Has heat-clearing and toxic substances removing, dissipating phlegm and resolving masses.Be used for the carbuncle furunculosis, scrofula sucutaneous nodule, tuberculous lymphadenitis, snake bite and insect sting.Chemical constituents such as the mucous matter of this product rhizome, glucomannan and mannose.

In sum, in conjunction with the character characteristics of each medical material in the prescription, water extraction is adopted in the decision of this preparation, now its experimental result is reported as follows.

2.2 decocting process research

(1) factor level is establishedThe factor that influence decocts mainly contains the following aspects: amount of water, decocting time, decoction number of times etc.Therefore we have carried out the quadrature investigation of 3 factors, 3 levels to these three principal elements, with preferred optimal processing parameter.The factor level table of orthogonal test sees Table 4.

Table 4 decocts orthogonal test factor level table

(2) index is selectedSemen Plantaginis has clearing away heat and promoting diuresis among the we, eliminating dampness by diuresis is treating stranguria, the expectorant function makes eye bright.Modern study proves that it has multinomial pharmacological actions such as diarrhea inducing, hepatoprotective, reduction serum cholesterol.The Semen Plantaginis main component is a galacturonic acid, therefore, its extracted amount as the orthogonal test evaluation index; The prescription Chinese crude drug also contains fat-soluble active ingredients such as alkaloid, and in order fully to reflect extraction effect, we measure the content of 60% ethanol soluble extraction in the extract, and also make the orthogonal test evaluation index with it; In addition, dried cream yield also is a conventional index of estimating extraction effect, and it directly influence the regulation of obeying dosage and single oral dose day, thus also with it as one of orthogonal test evaluation index.It is preferred that this test intended employing comprehensive grading method is carried out process conditions, because dried cream yield and effect amount are not proportional, stipulates that its balance is divided into 30 fens; The balance of 60% ethanol soluble extraction is divided into 30 fens; Effective ingredient in the Semen Plantaginis alduronic acid side of being can directly reflect extraction effect, is 40 fens so stipulate the balance branch of this index.

(3) sample preparationGet 1 recipe quantity medical material, amount to 71g, carry out water by each orthogonal test condition of table 4 and carry, medicinal liquid concentrates and is settled to 100ml after filtering with 300 order filter clothes.Standby.

(4) dried cream yield is measuredPrecision is got the medicinal liquid 25ml after each orthogonal test concentrates, puts respectively in the evaporating dish that has been dried to constant weight, and water bath method, residue takes out in 105 ℃ of dryings 3 hours, puts in the exsiccator and places 30 minutes, weighs, and calculates dried cream yield.

(5) 60% ethanol soluble extractions are measuredPrecision is got the medicinal liquid 50ml after each orthogonal test concentrates, and adds ethanol respectively and makes and contain the alcohol amount and reach 60%, leaves standstill cold preservation 24 hours, filters, filtrate water bath method, residue take out in 105 ℃ of dryings 3 hours, place exsiccator to place 30 minutes, weigh, calculate the extractum yield.

(6) galacturonic acid acidity test

Galacturonic acidThe preparation of reference substance solution: precision takes by weighing 105 ℃ of galacturonic acid reference substance 20mg that are dried to constant weight and puts in the 100ml volumetric flask, is diluted with water to scale, shakes up, and promptly gets reference substance solution.

The standard curve preparation: the 1. preparation of 0.1% carbazole standard solution: precision takes by weighing the 0.1g carbazole, puts in the 100ml volumetric flask, is diluted to scale with dehydrated alcohol, shakes up.2. the accurate galacturonic acid standard solution 0.15,0.30,0.45,0.60 of drawing, 0.75ml puts in the 10ml scale test tube, adds water to 1.0ml respectively, and other gets 1.0ml water as blank.Every pipe adds concentrated sulphuric acid 5.50ml, shakes up the back and heat 25min in boiling water bath.Be chilled to room temperature after the taking-up, add 0.1% carbazole 0.20ml, shake up.Heating 10min in boiling water bath, be chilled to the acid of room temperature after vulcanization to scale, shake up, according to ultraviolet visible spectrophotometry, measure absorbance at 524nm wavelength place, is vertical coordinate with the absorbance, and concentration is abscissa, the drawing standard curve;

The preparation of need testing solution: precision takes by weighing Semen Plantaginis coarse powder 1g and adds 20ml water and extract in boiling water bath 2 times, and each 4 hours, and stir moisturizing at any time.Filtered while hot, medicinal residues hot wash, merging filtrate, add 95% ethanol,, precipitate 2 times to containing alcohol amount 80%, centrifugal, will precipitate and use water dissolution, put in the 100ml volumetric flask, water is settled to scale, shake up, measure absorbance in accordance with the law, read the weight that contains galacturonic acid the need testing solution from standard curve, calculate, promptly.Orthogonal experiments and interpretation of result see Table 5, table 6.

Table 5 decocts the orthogonal experiments table

Annotate: dried cream yield scoring=(dried cream yield/maximum dry cream yield) * 30

60% ethanol soluble extraction scoring=(extractum yield/maximum extractum yield) * 30

Galacturonic acid extracted amount scoring=(galactose acetal extracted amount/maximum half lactobionic acid extracted amount) * 40

Comprehensive grading=dried cream yield scoring+60% ethanol soluble extraction scoring+galacturonic acid extracted amount scoring

Table 6 decocts analysis of variance table

Annotate: F _0.05(2,2)=19.00; F _0.01(2,2)=99.00

From table 5,6 analysis results as can be known, each factor effect primary and secondary is A＞B＞C; A, B, C factor all have significant difference, A in the A factor ₂＞A ₃＞A ₁So, select A ₂B in the B factor ₃＞B ₁＞B ₂So, select B ₃C in the C factor ₂＞C ₃＞C ₁So, select C ₂Therefore optimised process is A ₂B ₃C ₂Promptly add 10 times of water gagings, decocted 3 hours at every turn, decoct twice.

2.3 best decocting process checkingBecause preferred optimised process is not included in 9 tests of orthogonal array, so it is verified.Get orthogonal test with a collection of medical material, press A ₂B ₃C ₂Experimentize, verify 3 batches altogether, checking the results are shown in Table 7.

Table 7 decocts optimised process checking result

The checking result shows that this technology extractum yield, 60% ethanol soluble extraction content and galacturonic acid extracted amount are all more stable, can be used as the optimised process of extraction.

2.4 concentration technology is investigatedThe method for concentration that workshop is commonly used has normal pressure to concentrate and concentrating under reduced pressure.Concentrating under reduced pressure have consuming time less, characteristics that thickening temperature is low, therefore heat-sensitive ingredients is destroyed lessly, along with improving constantly of pharmaceutical equipment manufacturing technology, present Chinese medicine workshop has been more, and to adopt concentrating under reduced pressure be main.For with produce actual combining closely, the concentrated mode of this product adopts the concentrating under reduced pressure method.

Get 2 times of recipe quantity medical materials, extract by best decocting process, the decoction liquor concentrating under reduced pressure (0.06～-0.08Mpa, 80 ℃) to thick extractum, recording at this moment, the extractum relative density is about 1.25(60 ℃), it is an amount of to get extractum, the same method is measured wherein galacturonic acid content, and result of the test sees Table 8.

Galacturonic acid content measurement result in table 8 concentrated extract

Result of the test shows: adopt pressure reducing mode that this product extracting solution is concentrated, total galactose acetal content is stable in the prescription, and illustration method is feasible.

2.5 drying processWe adopt normal pressure and drying under reduced pressure dual mode that drying process is investigated respectively: the thick extractum mixing during concentration technology is investigated, be divided into 3 parts, carry out drying by condition in the table 9 respectively, content, color and luster, drying time with galacturonic acid in the gained extract powder serve as to investigate object, with this drying mode is carried out preferably the results are shown in Table 9.

The different drying mode investigation tables of table 9

Last watch test result shows that drying mode and drying condition do not have obvious influence to the galactose acetal content, but constant pressure and dry extractum color and luster is dark, required time is long, and by contrast, adopting decompression is that the drying process parameter is more suitable for 70 ℃.

2.6. preparation prescription research

(1) character of extract powderThe pitchy powder of this product extract powder for being prepared into behind drying under reduced pressure in order to grasp the character of extract powder, is convenient to preparation research, and we have measured the moisture absorption percentage rate and the flowability of extract powder.

(2) the moisture absorption percentage rate is measuredGet proper amount of dry extractum, pulverize, cross 80 mesh sieves, put P2O5 exsiccator inner drying 48 hours, the glass exsiccator that simultaneously bottom is filled the NaCl supersaturated solution is put into 25 ℃ calorstat 24 hours, and its internal relative humidity (RH) is 75%.In the weighing botle of dry constant weight, add an amount of extract powder, the about 2mm of thickness, precision is weighed and is placed in the above-mentioned glass exsiccator, opens the weighing bottle cap; Regularly weighing is calculated as follows the moisture absorption percentage rate:

Extract powder weight before extract powder weight-moisture absorption after the moisture absorption

Hydroscopicity=---------------------------------------* 100%

Extract powder weight before the moisture absorption

Table 10 extract powder moisture absorption percentage rate measurement result table

(3) measure angle of reposeAdopt the fixed funnel method to measure extract powder (80 order) angle of repose: with 3 funnels series connection and be fixed in suitable height (3cm) on the graph paper of horizontal positioned, carefully extract powder is poured in the uppermost funnel along hopper walls, till the extract powder apex partis petrosae termination that forms on the graph paper contacts bottom bell mouth, measure the conical base diameter, be calculated as follows out a angle of repose:

Cone height (3cm) (h)

tga=-----------------------

Cone radius (r)

Table 11 extract powder measurement result angle of repose

Extract powder moisture absorption percentage rate and angle of repose measurement result show that the extract powder moisture resistance is poor, mobile bad, be unsuitable for direct granulation, should add appropriate amount of auxiliary materials adjustment.

2.7 adjuvant screening

2.7.1 supplementary product kind screeningThe kind of adjuvant directly determines particulate hygroscopicity and flowability.Be commonly used to improve the granule hygroscopicity and lactose, starch and dextrin etc. arranged with mobile adjuvant.Get above-mentioned 3 kinds of adjuvants respectively by table 12 and add in the extract powder, mixing, with 75% ethanol system soft material, 10 orders are made granule excessively, and 65 ℃ of dry 15min are excessively behind the 10 mesh sieve granulate, again in 65 ℃ of dryings.The results are shown in Table 13,14.

Table 12 different auxiliary material and extract powder compatibility table

Table 13 different auxiliary material makes particulate index inspection

Table 14 different auxiliary material proportioning makes particulate moisture absorption percentage rate

As seen from table, different auxiliary material is with after dried cream powder mixes in varing proportions, and 3 groups of sample hydroscopicities are 1＞3＞2 in proper order.The hydroscopicity minimum (60h) of No. 2 prescriptions (single use starch) wherein, good fluidity; No. 3 prescriptions (single dextrin of using) the little tide of granule.Take all factors into consideration and select prescription down No. 2.

2.7.3 supplementary product consumption screeningThe consumption of adjuvant should satisfy under the prerequisite that preparation requires, and reduce consumption is principle as far as possible.Get starch respectively by table 15 and add in the extract powder, press preceding method and granulate back particulate moisture absorption percentage rate of mensuration and angle of repose.The results are shown in Table 16,17.

Table 15 supplementary product consumption compatibility table

The particulate moisture absorption percentage rate of table 16 different auxiliary material consumption

The different starch consumptions of table 17 particulate angle of reposes

Above-mentioned result of the test shows, it is many more to add the adjuvant amount, and particulate anti-wettability power and flowability are good more, and wherein every 20g extractum adding adjuvant 10g is suitable with adding 12g effect, in order to save production cost, we select every 20g extract powder to add adjuvant 10g is the supplementary product consumption parameter.

2.8 preparations shaping technical studyThe granulation concentration of alcohol is selected: get extract powder 20g, add starch 10g, mixing is used 60%, 75%, 95% alcohol granulation respectively, and investigating granulates is difficult to degree and makes particulate quality, the results are shown in Table 18.

Table 18 different concentration ethanol granulation information slip

Experimental result shows, makes granular mass the best with 75% ethanol, and therefore, selecting 75% ethanol is this product granulation solvent.

2.9 the preparation prescription and the amount of making are determinedBy the laws and regulations requirement that new drug is declared, the new drug prescription must be about 11% according to 3 batches of dried cream yields of pilot scale and calculate by 1000 preparation unit's statements, and this product preparation prescription calculates that process is as follows:

(1) dose of respectively distinguishing the flavor of in the preparation prescriptionFormer prescription ratio is Semen Plantaginis 1.5, Rhizoma Smilacis Glabrae 1, Pheretima 1, Caulis Lonicerae 1, Radix Clematidis 1, Radix Stephaniae Tetrandrae 1, Pseudobulbus Cremastrae Seu Pleiones 0.6, in each medical material amount in this ratio calculating this product preparation prescription is: Semen Plantaginis 450g, Rhizoma Smilacis Glabrae 300g, Pheretima 300g, Caulis Lonicerae 300g, Radix Clematidis 300g, Radix Stephaniae Tetrandrae 300g, Pseudobulbus Cremastrae Seu Pleiones 180g.Be that to contain the crude drug total amount be 2130g to preparation prescription.

(2) every bag granule contains the crude drug total amountEvery bag granule contains crude drug total amount=crude drug total amount ÷ preparation unit; That is: every bag granule contains crude drug total amount=2130g ÷ 1000=2.13g

(3) add the adjuvant amount in the preparation process

1. every prescription dry extract receipts amountIt is 2130g that preparation prescription contains the crude drug total amount, calculates if be about 12% according to dried cream yield, and then every prescription dry extract receipts amount is: every prescription dry extract receipts amount=prescription contains crude drug total amount * dried cream yield; That is: every prescription dry extract receipts amount=2556g * 12%=255.6g

2. supplementary product consumption is determinedBy preceding test as can be known, the ratio of dry extract and adding starch is 20: 10 in this product preparation process, calculates the starch consumption thus and is: the every prescription starch consumption=dried cream receipts of every prescription amount * 10 ÷ 20; That is: starch consumption=255.6g * 10 ÷ 20=127.8g

It is dry extract receipts amount and starch consumption sum that every prescription makes the content amount, by 1., 2.As can be known, this product makes content 383.4g.Consider that the medical material collecting season is different with the place of production, and the influence of production technology, dry extract receipts amount can slightly fluctuate, and we are described as supplementary product consumption: add right amount of auxiliary materials, making the content amount of making is 400g.

2.10 the finished product loading amount is determinedThe finished product loading amount =The content amount of the making ÷ amount of making

That is: finished product loading amount =1000=0.4g/ of 400g ÷ grain

3.11 pilot scale researchGet 20 times of recipe quantity medical materials, by work out to such an extent that process route carries out middle trial production, the production technology index is carried out comprehensive assessment, medical material and finished product are carried out performance rating, the results are shown in Table 19.

Table 19 pilot plant test result

The pilot plant test result of study shows that the every technical parameter of product of the present invention is stable, and feasible process is described, is fit to produce in batches.

Three, Pharmacodynamic test of active extract research

(1) experiment material

1, experimental animal mice, rat: institute provides by the Chongqing Chinese medicine research.

2, test drug and reagent medicine of the present invention, hereinafter to be referred as No. 1 semi-finished product of gout: Guiyang Chunke Pharmacy Group Technical Research Co., Ltd. provides, specification: the 5kg/ bag, every gram contains crude drug 5.325g.Lot number: 2009001.Colchicine: O.5mg every contain colchicine.Uric acid sodium: specification: 5g/ bottle.Hypoxanthine: specification: 25g/ bottle.Put and exempt from medicine box: the blood uric acid test kits.Nicotinic acid: specification: 50mg.FAA solution (formaldehyde, glacial acetic acid, 70% ethanol).Acetum: O.6%, O.7%.Dimethylbenzene (chemical pure).The blue normal saline solution of ivens: O.5%.Aspirin: specification: 0.5g/ bottle.

3, experimental apparatus rat paw volumetric measurement instrument; Electronics tenderness instrument; Ultra-violet and visible spectrophotometer; The medical image analysis system; Trace electronics Libra; Inverted microscope; Electro-heating standing-temperature cultivator; The radioimmunity enumerator; The constant temperature water bath agitator; Centrifuge.

(2) No. 1, gout is to the influence of rat acute gouty arthritis due to the uric acid sodium

1, experimental technique

1.1 laboratory animal: select the Wister rat for use, 60, male.Body weight 200+20 gram.

1.2 test drug: No. 1, (1) gout; (2) uric acid sodium solution: normal saline is mixed with 2.5%.(3) positive control drug (colchicine): be mixed with O.6%.(4) put and exempt from medicine box: PLA General Hospital Science and Technology Development Center puts and exempts from institute.

1.3 test grouping and dosage: 60 rats are divided at random: blank group, model group, positive drug control group, No. 1 high dose group of gout, middle dosage group, low dose group.Every group each 10.Every day, gastric infusion was 1 time, successive administration 5 days.Dosage is respectively: No. 1 high dose group: 3.0g/kg of gout; Dosage group: 1.5g/kg in No. 1, the gout; No. 1 low dose group: 0.75g/kg of gout; Positive drug control group (colchicine): 0.5g/kg; Blank group, model group: irritate stomach with the volume pure water.

1.4 the clone method of gouty arthritis modeling: before stomach is irritated in the 3rd day of experiment, begin modeling, with iodine tincture, ethanol disinfection part, with No. 4.5 entry needles of sterilizing on the rat right side apart from shank (ankle) joint dorsal part, from 45 ^°Direction is inserted into tibia tendon inboard, and 0.2ml is injected into articular cavity with the uric acid sodium solution.Blank group injection 0.2ml normal saline.All rats of 72h sacrificed by decapitation after the modeling.

1.5 observation index:

(1) General observation: the diet of gross examination of skeletal muscle rat, urine just, hair color, the mental status and active situation.

(2) gait changes: 24h observes the gait variation of respectively organizing rat after the modeling, and the classified estimation medicine is to the influence of animal gait.

(3) tried the footpath variation of joint week: measure the sufficient volume (m1) of every right back sufficient talocrural joint of rat before the modeling with volumetric method, as the basic volume of the foot before the model.Before putting to death animal (72h after being modeling), measure every rat same area once more with volumetric method.Calculate swelling percentage rate and inhibitory rate of intumesce by following formula.

Swelling rate (%)=(cause scorching metapedes sole of the foot volume consistent scorching front foot sole of the foot volume)/cause scorching front foot sole of the foot volume * 100%

Suppression ratio (%)=(the average swelling rate of the average swelling rate one administration group of the model control group)/average swelling rate of model control group * 100%

(4) IL-1 β, IL-6 Determination on content in the serum: extracting vein blood 2ml, 3000rpm, centrifugal 15min, separation of serum is measured by putting the method for exempting from, and asks the content of IL.1D, IL.6 in every milliliter of serum.

(5) soft tissue of joint pathology: after taking off soft tissue of joint, FAA is liquid-solid to decide 48h, decalcifying agent decalcification 72h, ethanol dehydration step by step, transparent, the waxdip of dimethylbenzene, paraffin embedding, conventional section 4 capes, hematoxylin. Yihong dyeing.Quantitative observation under the medical image analysis system, counting is respectively organized unit are inflammatory cell number and is respectively organized interstice's area summation.

Table 20 classified estimation reference standard

1.5 statistical procedures as a result: each is organized data and represents that with mean plus-minus standard deviation the significance test of group difference is checked with t.

2, experimental result

2.1 General observation: in experimentation, blank group rat fur is moistened in vain, and activity is quick on the draw freely, and diet and urine are just normal; Positive drug control group engenders that then chaeta owes gloss, and spirit is not good enough, and lazy moving, appetite reduces, loose stool; No. 1 each administration group of gout and model group spirit, diet still can, chaeta is owed gloss slightly, stool is normal.

2.2 the influence that gout changes the animal gait for No. 1: animal gait observed result shows, model group and blank group are relatively, integration obviously raises, positive drug control group, No. 1 high, middle dosage group of gout and the apparent in view reduction of model group [P (0.01,0.05)].The result sees table 21 for details.

The influence that table 21 gout changes the rat gait for No. 1 (x ± S)

Compare with model group: * * * P＜0.00l, * * P＜0.0l, * P＜0.05.

2.3 No. 1 influence to rat model arthroncus rate of gout: this test adopts volumetric method to measure each group model animal modeling front and back volumetrical variation in joint, by data in the table as seen, directly all there is increase in various degree in joint week before and after each treated animal modeling, and wherein, model group increases the most obvious.Positive drug control group, the right foot swelling degree of No. 1 high, middle dosage group rat of gout and apparent in view the alleviating of the model group same period show that gout can alleviate arthroncus No. 1, the results are shown in Table 22.

No. 1, table 22 gout is tried the influence (x ± S) of joint Zhou Jing to rat

Compare with the blank group: * * * P＜0.001, * * P＜0.0l.Compare with model group: ###P＜0.001, ##P＜0.01, #P＜0.05.

2.4 No. 1 influence to worker L-1B, IL-6 content in the rat blood serum of gout: the result shows, its serum OPIL-1B, IL-6 content all obviously raise after each treated animal modeling, model group, No. 1 low dose group of gout and blank group relatively have significant difference (P＜0.001, P＜0.01).Gout No. 1 high, middle dosage treated animal serum il-1 β, IL-6 content obviously reduce, and with model group significant difference (P＜O.05, P＜0.001) are arranged more all.The results are shown in Table 23.

No. 1 influence to IL-1 β, IL-6 content in the rat blood serum of table 23 gout (X ± S)

Compare with the blank group: * * * P＜0.001.**P＜0.01.Compare with model group: ###P＜0.001.#P<0.05。

2.5 gout is tried the soft tissue of joint pathological change for No. 1 to rat influence is by data in the table as seen, model group and blank group relatively, unit are inflammatory cell number and interstice's area summation obviously raise, and show that model group makes the inflammation edema model successfully.Each administration group and model group compare, and interstice's area and unit are inflammatory cell number average significantly reduce (P＜0.05,0.01), show that gout can alleviate tissue edema No. 1, and No. 1 high dose group effect of gout is near the effect of Western medicine colchicine.See table 24, table 25 for details.

The comparison of each treated animal unit are inflammatory cell counting of table 24 (X ± S)

Compare with the blank group: * * * P＜0.001.Compare with model group: ###P＜0.001, ##P＜0.01, #P＜0.05.

The comparison of each treated animal interstice area summation of table 25 (X ± S)

Compare with the blank group: * * * P＜0.001.Compare with model group: ###P＜0.001, ##P＜0.01, #P＜0.05.

(3) No. 1 influence of gout to hyperuricemia rat serum uric acid level

1, experimental technique

1.1 laboratory animal: select rat for use, 60, male, body weight 200 ± 20 grams.

1.2 test drug: No. 1, (1) gout; (2) hypoxanthine; (3) nicotinic acid; (4) positive control drug: colchicine.

1.3 test grouping and dosage: 60 rats are divided at random: blank group, model group, positive drug control group, No. 1 high dose group of gout, middle dosage group, low dose group.Every group of each l0 only.Every day gastric infusion once, successive administration 4 days.Dosage is respectively: No. 1 high dose group: 3.0g/kg of gout; Dosage group: 1.5g/kg in No. 1, the gout; No. 1 low dose group: 0.75g/kg of gout; Positive drug control group (colchicine): 0.5g/kg; Blank group, model group: irritate stomach with the volume pure water.

1.4 experimental technique: behind each treated animal last administration lh, all the other 5 treated animal Intraperitoneal injection of hypoxanthine 100mg/kg body weight are irritated stomach simultaneously and are given nicotinic acid 80mg/kg body weight except that the blank group.The isometric normal saline of blank treated animal lumbar injection is irritated stomach and is given with the volume pure water.Injection back 30min, each treated animal is through abdominal aortic blood, and the centrifugal 15min of 3000rpmin gets serum, presses the operation of blood uric acid testing cassete description, surveys the hematuria acid number.

1.5 statistical procedures as a result: each is organized data and represents that with mean plus-minus standard deviation the significance test of group difference is checked with t.

2, experimental result: the result shows, compares with the blank group, and model group animal hematuria acid number obviously raises, prompting modeling success.Positive drug control group, No. 1 high dose group of gout and model group compare, and the hematuria acid number obviously reduces, and shows that gout can reduce the serum uric acid level of hyperuricemia rat No. 1, and its effect is close with colchicine.The results are shown in Table 26.

No. 1 influence to hyperuricemia rat serum uric acid level of table 26 gout (X ± S)

Compare with the blank group: * * * P＜0.001.Compare with model group: ###P＜0.001, #P＜0.05.

(4) No. 1 effect of gout to other inflammation:

1, the influence of No. 1 xylol induced mice of gout auricle inflammatory swelling

1.1 experimental technique

1.1.1 laboratory animal: 50 of kunming mices, body weight 20 ± 2 grams, male and female half and half.

1.1.2 experimental drug: No. 1, gout: the same experiment.Aspirin: specification: 0.5g/ sheet.Dimethylbenzene: commercially available chemical pure.

1.1.3 the preparation of test drug: compound concentration is: No. 1, gout: 30%, 15%, 7.5%.Positive controls: aspirin 3%; The distilled water preparation is irritated stomach and is used under the suspension.

1.1.4 animal grouping and dosage: get 50 of mices, be divided into 5 groups at random, be i.e. blank group, model group, positive drug control group, No. 1 high, medium and low dosage group of gout, 10 every group.Every day gastric infusion once, successive administration 3 days.Dosage is respectively: high dose group: 3.0g/kg; Middle dosage group: 1.5g/kg; Low dose group: 0.75g/kg; Positive controls (aspirin): 0.6g/kg; Model group gives pure water 20ml/kg.

1.1.5 behind the laboratory animal last administration 30min, be positioned over mouse right ear shell l0 second up and down with the cotton balls that dips in dimethylbenzene, left ear does not deal with in contrast.Put to death animal behind the 15min, cut ears, get round auricle at same position respectively with diameter 7mm card punch along the auricle baseline.Take by weighing the weight (mg) of left and right sides auricle respectively with micro-electronics Libra, the weight that deducts left auricle with auris dextra sheet weight is the swelling degree.Calculate and respectively organize the average swelling degree of Mice Auricle, and by formula calculate the auricle edema suppression ratio of administration group and control animals.

Suppression ratio (%)=(the average swelling rate of the matched group-average swelling rate of administration the group)/average swelling rate of matched group * 100%

1.2 experimental result: the result shows that No. 1 each administration group mice ear degree of aspirin group and gout all is starkly lower than matched group (P＜0.05,0.01).Show that No. 1, gout organizes exudative inflammation that certain inhibitory action is arranged due to chemical factor is stimulated.See table 27 for details.

No. 1 influence to the Mice Auricle inflammatory swelling of table 27 gout (x ± S, n=l0)

2, the influence of No. 1 Dichlorodiphenyl Acetate induced mice of gout abdominal cavity capillary permeability

2.1 experimental technique

2.1.1 experimental animal is selected: select kunming mice for use, male and female half and half, body weight 20 ± 2 grams.

2.1.2 test drug: be subjected to the reagent product: No. 1, gout; Positive control drug: aspirin.

2.1.3 the preparation of test drug: compound concentration is: No. 1, gout: 30%, 15%, 7.5%.Aspirin: 3%; The distilled water preparation is irritated stomach and is used under the suspension.

2.1.4 animal grouping and dosage: get 50 of mices, be divided into 5 groups at random, be i.e. matched group, positive drug control group, No. 1 high, medium and low dosage group of gout, 10 every group.Dosage design: high dose group: 3.0g/kg; Middle dosage group: 1.5gk/g; Low dose group: 0.75g/kg; Positive controls (aspirin): 0.6g/kg; Blank group: pure water 20ml/kg.

2.1.5 experimental technique and operating procedure: animal is weighed, labelling, record body weight; Gastric infusion: every day gastric infusion once, successive administration 7 days.Behind the laboratory animal last administration 30min, mice is all through the blue normal saline solution of the ivens of tail vein injection 0.5% body weight O.1ml/10g, lumbar injection acetum O.6% O.2ml/ only immediately: vertebral pulling is put to death behind the 20min, cut off the abdominal cavity, divide several to wash abdominal cavity, sucking-off cleaning mixture with the 6ml normal saline; Merge cleaning mixture and add normal saline to 10ml, the centrifugal 15min of 3000rpmin; Get supernatant; Carry out colorimetric in wavelength 590nm place, measure each treated animal abdominal cavity cleaning mixture dyestuff absorbance (Av).

2.1.6 statistical procedures: the absorbance of each treated animal abdominal cavity cleaning mixture represents that with mean plus-minus standard deviation the significance of difference is checked with t between group.

2.2 experimental result: the result shows that the absorbance of No. 1 3.0g/kg dosage of gout treated animal abdominal cavity cleaning mixture is starkly lower than matched group (P＜0.05).Illustrate that the mouse peritoneal capillary permeability increase due to No. 1 Dichlorodiphenyl Acetate of gout has certain inhibitory action.Experimental result sees table 28 for details.

Table 28 is respectively organized mouse peritoneal cleaning mixture absorbance (X ± S)

(5) No. 1 analgesic activity of gout

1, No. 1 experiment of analgesic of gout is observed (writhing method)

1.1 experimental technique

1.1.1 experimental animal and grouping: 50 of kunming mices, body weight 20 ± 2 grams, male and female half and half.Be divided into 5 groups at random, i.e. matched group, positive drug control group, No. 1 high, medium and low dosage group of gout, 10 every group.

1.1.2 test drug and reagent: be subjected to the reagent product: No. 1, gout, compound concentration during test: 30%, 15%, 7.5% suspension uses for irritating stomach; Positive control drug: aspirin: concentration 3%.Acetum: 0.7%.

1.1.3 experimental technique and operating procedure: animal is weighed, labelling, record body weight; Medication and dosage: each treated animal is through gastric infusion, and dosage is respectively: No. 1 high dose group: 3.0g/kg of gout; Middle dosage group: 1.5g/kg; Low dose group: 0.75g/kg; Positive controls (aspirin): 0.6g/kg; Blank group: pure water 20ml/kg.Every day gastric infusion once, successive administration 5 days.Behind the last administration 30min, mice is all through the acetum 0.1ml/10g of lumbar injection 0.7%.The number of times of turning round the body appearance that each mice 10min of observed and recorded is interior respectively.Calculate the analgesia percentage rate.

1.2 experimental result: the result shows that No. 1 each dosed administration of gout has the obvious suppression effect to the pain (writhing response) due to the lumbar injection acetum.See table 29 for details.

Each treated animal of table 29 is turned round body number of times (X ± S)

Compare with matched group: * P＜0.05; : * * P＜0.01; * * P＜0.001.

2, No. 1 experiment of analgesic of gout is observed (tenderness method)

2.1 experimental technique

2.1.1 experimental animal and grouping: the screening of experimental animal:, when rat produces the qualified rat that is that shouts for three times in the 200.1200g pressure limit, and write down its pain threshold with YLS-3E tenderness instrument screening rat.Select 50 of qualified rats, body weight 150～200 grams, male and female half and half.50 rats are divided into 5 groups at random, i.e. matched group, aspirin matched group, No. 1 high, medium and low dosed administration group of gout, 10 every group.

2.1.2 medication and dosage: all animals are with gastric infusion, and dosage is respectively: No. 1 high dose group: 2.4g/kg of gout; Middle dosage group: 1.2g/kg; Low dose group: 0.6g/kg; Positive controls (aspirin): 0.5g/kg; Blank group: pure water 10ml/kg.Every morning gastric infusion once, successive administration 5 days.After the administration phase finishes, adopt the tenderness method to measure each rat pain threshold when 30min, 60min and 120min after administration.

2.1.3 test method: respectively rat is placed under the YLS-3E tenderness instrument apparatus depression bar, presses the operation key, after display lamp is bright, press again that initiating key is descending exerts pressure, when animal shouts because of pain produces, press initiating key pressure return again.The shown data of exerting pressure (gram) of record screen.

2.2 experimental result: No. 1 (2.4g/kg) administration of gout treated animal records pain threshold apparently higher than concurrent control group (P＜0.0l:P＜0.001) on 30min, 60min, 120min time point after the administration, No. 1 (1.4g/kg) administration of gout group records pain threshold on 30min, 60min time point after the administration and matched group relatively has significant difference (P＜0.05), and No. 1 (0.75g/kg) administration of gout group records pain threshold on 60min time point after the administration and matched group relatively has significant difference (P＜0.05).Show that No. 1, gout has certain inhibitory action to physical factor is pain caused, but effect is weaker than the aspirin matched group.

Each treated animal pain threshold of table 30 (X ± S, N=10)

Compare with matched group: * P＜0.05:**P＜0.01; * * P＜0.001.By above-mentioned writhing method, two kinds of analgesic activity experimental techniques of tenderness method No. 1 experiment of analgesic of gout is observed, show that gout has significant analgesia role No. 1, as seen increase analgesic activity in the experiment and strengthen to some extent with dosage.

Four, toxicity test research

No. 1 animal acute toxicity test of gout:Said preparation is a capsule, and according to the trial test situation, the high dose group animal does not see death after the grouping administration, can't find out maximum lethal dose, measures so can't carry out the animal median lethal dose(LD 50).The maximum dosage-feeding that changes the animal oral administration into is measured.

No. 1 clinical administration amount of gout is finished medicines 3.6g/ day (being equivalent to crude drug 19.17g), is equivalent to (60 kilograms) per kilogram of body weight 0.06g/kg (amounting to crude drug amount 0.3195g/kg).

This test is chosen and is used the finished product administration.Mice is irritated gastric capacity (40m1/kg body weight) No. 1 (Cmax 40%) administration that gives the Cmax gout by maximum in the test, can't increase again because of being subjected to drug level and irritating the long-pending dosage of limitting of body of stomach, so dosage reached maximum dosage, dosage is accumulated as 12g/kg (amounting to the crude drug amount is 63.9g/kg) in the animal subject 24 hours as a result.

No. 1 oral maximum dosage-feeding of mice of gout has been reached 200 times of people's consumption every day (amounting to crude drug amount 0.3195g/kg) as calculated.Observed 14 days continuously after the administration, all are tried mice and there is no unusual performance, none death.

According to statistics Wlrightization rule, can infer that a day maximum dosage-feeding that No. 1 oral administration of gout must be greater than 12g/kg (amount to crude drug: amounting to the crude drug amount be 63.9g/kg).

The comparison of table 31 medicine maximum dosage-feeding of the present invention experiment mice body weight

Five, clinical practice

(1) physical data: sick 110 examples of this group treatment, wherein male 86 examples, women 24 examples, age 18--65 year.Meet the goat occurrence regularity.

(2) diagnostic criteria

L, Western medicine diagnose standard: the acute arthritis outbreak that (1) is once above; (2) inflammation shows in the 24h and peaks; (3) monarthritis outbreak; (4) diseased joints is kermesinus: (5) the 1st metatarsophalangeal joints pain or swelling; (6) midtarsal joints is involved in one-sided outbreak; (7) both sides the 1st metatarsophalangeal joints swelling or pain; (8) suspicious tophus is arranged; (9) hyperuricemia; (10) x line sheet: show joint asymmetry swelling; (11) x line sheet: show that cyst is not accompanied bone erosion under the cortical bone; (12) arthritis stage of attack joint fluid microorganism culturing feminine gender.

2, tcm diagnosis standard: (1) main clinical manifestation: joint, muscles and bones position swelling pain, local dark red, numbness is weighing, joint stuffiness, even joint swelling deformation, heating.(2) characteristics of incidence: how relevant with eating and drinking without temperance.(3) sex age characteristics: good sending out in person between twenty and fifty, see with the male especially more.(4) physico-chemical examination: erythrocyte sedimentation rate speeds, or leukocyte increases, and blood uric acid increases, and CRP (c reactive protein) increases.

3, Chinese medical discrimination: damp-heat accumulation disease: the redness and swelling of joints burning pain, sense of heaviness is arranged, walk with difficulty heating, the yellow erosion of urine, red tongue, yellow and greasy fur, soft and rapid pulse or sliding number.

(3) Therapeutic Method: treatment group 60 example is with No. 1 sides of gout (Semen Plantaginis 15g, Rhizoma Smilacis Glabrae 10g, Pheretima 10g, Caulis Lonicerae 10g, Radix Clematidis 10g, Radix Stephaniae Tetrandrae 10g, Pseudobulbus Cremastrae Seu Pleiones 6g), and it is for oral administration to fry in shallow oil soup, one day 1 dose, 15 days be-course of treatment 2 courses of treatment of logotype.Matched group 30 routine oral colchicine sheets, every 0.5mg, oral.Acute stage: adult's usual amounts is per 1～2 hour clothes 0.5～1mg, until the joint remission, or diarrhoea or vomiting occur, reach therapeutic dose and be generally 3～5mg, should not surpass 6mg in 24 hours, withdraw that daily dose is 0.5～1.5mg after 72 hours, part vic, totally 7 days.

(4) efficacy assessment standard: produce effects: joint congestion and swelling pain disappears, and it is normal that movable function recovers, and main physico-chemical examination index is normal.Effectively: joint congestion and swelling pain is eliminated to some extent or is alleviated, and movable function recovers substantially, and main physico-chemical examination index makes moderate progress.Invalid: with the treatment before compare, each side does not all have progress.

Five, therapeutic outcome

Table 32 treatment back blood uric acid mean concentration result of variations (umol/L)

Table 33 treatment back efficacy result

Test statistics shows: with Drug therapy 75 examples of the present invention, and produce effects 44 examples as a result, effective 27 examples, invalid 6 examples, obvious effective rate is 58.7%, and effective percentage is 36.0%, and total effective rate is 94.7%.Contrast medicine Colchicum autumnale group 35 examples, produce effects 15 examples, effective 17 examples, invalid 3 examples, obvious effective rate is 42.9%, and effective percentage is 48.6%, and total effective rate is 91.5%.Clinical comparison is used and is shown, medicine of the present invention is in treatment gout and similar to Colchicum autumnale to the effect of hyperuricemia, but the toxic and side effects of medicine of the present invention is low than Colchicum autumnale, does not in use find toxic and side effects.The result shows that medicine of the present invention can effectively be treated gout and hyperuricemia, and safety, is worthy of popularization.

Compared with prior art, medicine effect of the present invention is fast, and is safe in utilization, have no side effect, and is a kind of new Chinese medicine of safe, effective, quality controllable gout prevention.

The specific embodiment

Embodiment 1: prescription: Semen Plantaginis 15g, Rhizoma Smilacis Glabrae 10g, Pheretima 10g, Caulis Lonicerae 10g, Radix Clematidis 10g, Radix Stephaniae Tetrandrae 10g, Pseudobulbus Cremastrae Seu Pleiones 6g.

Usage: it is for oral administration to fry in shallow oil water, one day 1 dose.

Embodiment 2: prescription: Semen Plantaginis 450g, Rhizoma Smilacis Glabrae 300g, Pheretima 300g, Caulis Lonicerae 300g, Radix Clematidis 300g, Radix Stephaniae Tetrandrae 300g, Pseudobulbus Cremastrae Seu Pleiones 180g.

Method for making: get above seven flavor medicine material, 10 times of decoctings that add the total amount of writing out a prescription boil 2 times, decoct 3 hours at every turn, filter, it is 1.25(60 ℃ that filtrate is concentrated into relative density) extractum, add right amount of auxiliary materials, granulate drying, fill is made 1000, promptly gets capsule of the present invention.Specification: every dress 0.4g.

Usage: oral, one time 3,3 times on the one.

Embodiment 3: prescription: Semen Plantaginis 450g, Rhizoma Smilacis Glabrae 300g, Pheretima 300g, Caulis Lonicerae 300g, Radix Clematidis 300g, Radix Stephaniae Tetrandrae 300g, Pseudobulbus Cremastrae Seu Pleiones 180g.

Method for making: get above seven flavor medicine material, 10 times of decoctings that add the total amount of writing out a prescription boil 2 times, decoct 3 hours at every turn, filter, it is 1.25(60 ℃ that filtrate is concentrated into relative density) extractum, drying under reduced pressure is pulverized, cross 80 mesh sieves, add right amount of auxiliary materials, granulate drying, add 0.5% magnesium stearate mixing, compress tablet coating is made 1000, promptly gets tablet of the present invention.Specification: every heavy 0.4g.

Usage: oral, one time 3,3 times on the one.

Embodiment 4: prescription: Semen Plantaginis 270g, Rhizoma Smilacis Glabrae 180g, Pheretima 180g, Caulis Lonicerae 180g, Radix Clematidis 180g, Radix Stephaniae Tetrandrae 180g, Pseudobulbus Cremastrae Seu Pleiones 108g.

Method for making: get above seven flavor medicine material, 10 times of decoctings that add the total amount of writing out a prescription boil 2 times, decoct 3 hours at every turn, filter, it is 1.25(60 ℃ that filtrate is concentrated into relative density) extractum, add right amount of auxiliary materials, add suitable quantity of water mix thoroughly agglomerating to what hold, pressure can loose for the degree, the cutting pill.Molding, capping, coating is made 1000 balls, promptly gets pill of the present invention.Specification: the heavy 2.0g of per 10 balls.

Usage: oral, one time 5 ball, 3 times on the one.

Embodiment 5: prescription: Semen Plantaginis 675g, Rhizoma Smilacis Glabrae 450g, Pheretima 450g, Caulis Lonicerae 450g, Radix Clematidis 450g, Radix Stephaniae Tetrandrae 450g, Pseudobulbus Cremastrae Seu Pleiones 270g.

Method for making: get above seven flavor medicine material, 10 times of decoctings that add the total amount of writing out a prescription boil 2 times, decoct 3 hours at every turn, filter, it is 1.25(60 ℃ that filtrate is concentrated into relative density) extractum, add the Sugarless type right amount of auxiliary materials, mixing is granulated, drying, packing is made 1000g, promptly gets granule of the present invention.

Specification: every packed 2.0g.

Usage: oral, one time 1 bag, 3 times on the one.

Embodiment 6: prescription: Semen Plantaginis 135g, Rhizoma Smilacis Glabrae 90g, Pheretima 90g, Caulis Lonicerae 90g, Radix Clematidis 90g, Radix Stephaniae Tetrandrae 90g, Pseudobulbus Cremastrae Seu Pleiones 54g.

Method for making: get above seven flavor medicine material, 10 times of decoctings that add the total amount of writing out a prescription boil 2 times, decoct 3 hours at every turn, standing over night is got supernatant and is filtered merging filtrate, be evaporated to about 800ml, add the Sugarless type right amount of auxiliary materials, sodium benzoate is an amount of, mixing is heated to and boils, and puts to room temperature, it is an amount of to add essence again, adds water to 1000ml, mixing, filter, fill promptly gets oral liquid of the present invention.

Specification: every bottled 10ml.

Usage: oral, one time 1 bottle, 3 times on the one.

Embodiment 7: prescription: Semen Plantaginis 67.5g, Rhizoma Smilacis Glabrae 45g, Pheretima 45g, Caulis Lonicerae 45g, Radix Clematidis 45g, Radix Stephaniae Tetrandrae 45g, Pseudobulbus Cremastrae Seu Pleiones 27g.

Method for making: get above seven flavor medicine material, 10 times of decoctings that add the total amount of writing out a prescription boil 2 times, decoct 3 hours at every turn, and standing over night is got supernatant and filtered, and merging filtrate, being evaporated to relative density is 1.25(20 ℃) clear paste, spray drying, fine powder is standby; Add in the fused polyethylene glycol 6000, stir evenly, splash in the methyl-silicone oil, take out, drop pill is absorbed condensed fluid, and drying is made 1000, promptly gets drop pill of the present invention.

Specification: every heavy 40mg.

Usage: oral, one time 10,3 times on the one.

Embodiment 8: prescription: Semen Plantaginis 2130g, Rhizoma Smilacis Glabrae 3408g, Pheretima 3408g, Caulis Lonicerae 3408g, Radix Clematidis 3408g, Radix Stephaniae Tetrandrae 3408g, Pseudobulbus Cremastrae Seu Pleiones 2310g.

Method for making: get above seven flavor medicine material, 8 times of decoctings that add the total amount of writing out a prescription boil 3 times, decoct 1 hour at every turn, filter, it is 1.35(60 ℃ that filtrate is concentrated into relative density) extractum, add right amount of auxiliary materials, granulate drying, fill is made 10000, promptly gets capsule of the present invention.

Specification: every dress 0.4g.

Usage: oral, one time 3,3 times on the one.

Embodiment 9: prescription: Semen Plantaginis 7029g, Rhizoma Smilacis Glabrae 2556g, Pheretima 2556g, Caulis Lonicerae 2556g, Radix Clematidis 2556g, Radix Stephaniae Tetrandrae 2556g, Pseudobulbus Cremastrae Seu Pleiones 1491g.

Method for making: get above seven flavor medicine material, 12 times of decoctings that add the total amount of writing out a prescription boil 1 time, decoct 3 hours at every turn, filter, it is 1.30(60 ℃ that filtrate is concentrated into relative density) extractum, add right amount of auxiliary materials, mixing is granulated, drying, fill is made 10000, promptly gets capsule of the present invention.

Specification: every dress 0.4g.

Usage: oral, one time 3,3 times on the one.

Embodiment 10: prescription: Semen Plantaginis 9kg, Rhizoma Smilacis Glabrae 6kg, Pheretima 6kg, Caulis Lonicerae 6kg, Radix Clematidis 6kg, Radix Stephaniae Tetrandrae 6kg, Pseudobulbus Cremastrae Seu Pleiones 3.6kg.

Method for making: get above seven flavor medicine material, 10 times of decoctings that add the total amount of writing out a prescription boil 2 times, decoct 3 hours at every turn, filter, it is 1.25(60 ℃ that filtrate is concentrated into relative density) extractum, add right amount of auxiliary materials, mixing is granulated, drying, fill is made 20000, promptly gets capsule of the present invention.

Specification: every dress 0.4g.

Usage: oral, one time 3,3 times on the one.

Embodiment 11: prescription: Semen Plantaginis 5325g, Rhizoma Smilacis Glabrae 2769g, Pheretima 2769g, Caulis Lonicerae 2769g, Radix Clematidis 2769g, Radix Stephaniae Tetrandrae 2769g, Pseudobulbus Cremastrae Seu Pleiones 2130g.

Method for making: get above seven flavor medicine material, 6 times of decoctings that add the total amount of writing out a prescription boil 3 times, decoct 2 hours at every turn, filter, it is 1.35(60 ℃ that filtrate is concentrated into relative density) extractum, drying under reduced pressure is pulverized, cross 80 mesh sieves, add right amount of auxiliary materials, granulate drying, add 0.5% magnesium stearate mixing, compress tablet coating is made 10000, promptly gets tablet of the present invention.

Specification: every heavy 0.4g.

Usage: oral, one time 3,3 times on the one.

Embodiment 12: prescription: Semen Plantaginis 8520g, Rhizoma Smilacis Glabrae 5964g, Pheretima 5964g, Caulis Lonicerae 5964g, Radix Clematidis 5964g, Radix Stephaniae Tetrandrae 5964g, Pseudobulbus Cremastrae Seu Pleiones 4260g.

Method for making: get above seven flavor medicine material, 12 times of decoctings that add the total amount of writing out a prescription boil 2 times, decoct 1 hour at every turn, filter, it is 1.30(60 ℃ that filtrate is concentrated into relative density) extractum, drying under reduced pressure is pulverized, cross 80 mesh sieves, add right amount of auxiliary materials, granulate drying, add 0.5% magnesium stearate mixing, compress tablet coating is made 20000, promptly gets tablet of the present invention.

Specification: every heavy 0.4g.

Usage: oral, one time 3,3 times on the one.

Embodiment 13: prescription: Semen Plantaginis 4.5kg, Rhizoma Smilacis Glabrae 3kg, Pheretima 3kg, Caulis Lonicerae 3kg, Radix Clematidis 3kg, Radix Stephaniae Tetrandrae 3kg, Pseudobulbus Cremastrae Seu Pleiones 1.8kg.

Method for making: get above seven flavor medicine material, 10 times of decoctings that add the total amount of writing out a prescription boil 2 times, decoct 3 hours at every turn, filter, it is 1.25(60 ℃ that filtrate is concentrated into relative density) extractum, drying under reduced pressure is pulverized, cross 80 mesh sieves, add right amount of auxiliary materials, granulate drying, add 0.5% magnesium stearate mixing, compress tablet coating is made 10000, promptly gets tablet of the present invention.

Specification: every heavy 0.4g.

Usage: oral, one time 3,3 times on the one.

Embodiment 14: prescription: Semen Plantaginis 5.4kg, Rhizoma Smilacis Glabrae 3.6kg, Pheretima 3.6kg, Caulis Lonicerae 3.6kg, Radix Clematidis 3.6kg, Radix Stephaniae Tetrandrae 3.6kg, Pseudobulbus Cremastrae Seu Pleiones 2.16kg.

Method for making: get above seven flavor medicine material, 10 times of decoctings that add the total amount of writing out a prescription boil 2 times, decoct 3 hours at every turn, filter, it is 1.25(60 ℃ that filtrate is concentrated into relative density) extractum, add right amount of auxiliary materials, add suitable quantity of water mix thoroughly agglomerating to what hold, pressure can loose for the degree, the cutting pill.Molding, capping, coating is made 10000 balls, promptly gets pill of the present invention.

Specification: the heavy 2.0g of per 10 balls.

Usage: oral, one time 5 ball, 3 times on the one.

Embodiment 15: prescription: Semen Plantaginis 13.5kg, Rhizoma Smilacis Glabrae 9kg, Pheretima 9kg, Caulis Lonicerae 9kg, Radix Clematidis 9kg, Radix Stephaniae Tetrandrae 9kg, Pseudobulbus Cremastrae Seu Pleiones 5.4kg.

Method for making: get above seven flavor medicine material, 8 times of decoctings that add the total amount of writing out a prescription boil 3 times, decoct 1 hour at every turn, filter, it is 1.35(60 ℃ that filtrate is concentrated into relative density) extractum, add the Sugarless type right amount of auxiliary materials, mixing is granulated, drying, packing is made 20000g, promptly gets granule of the present invention.

Specification: every packed 2.0g.

Usage: oral, one time 1 bag, 3 times on the one.

Embodiment 16: prescription: Semen Plantaginis 2700g, Rhizoma Smilacis Glabrae 1800g, Pheretima 1800g, Caulis Lonicerae 1800g, Radix Clematidis 1800g, Radix Stephaniae Tetrandrae 1800g, Pseudobulbus Cremastrae Seu Pleiones 1080g.

Method for making: get above seven flavor medicine material, 12 times of decoctings that add the total amount of writing out a prescription boil 1 time, decoct 3 hours at every turn, standing over night is got supernatant and is filtered merging filtrate, be evaporated to about 800ml, add the Sugarless type right amount of auxiliary materials, sodium benzoate is an amount of, mixing is heated to and boils, and puts to room temperature, it is an amount of to add essence again, adds water to 20000ml, mixing, filter, fill promptly gets oral liquid of the present invention.

Specification: every bottled 10ml.

Usage: oral, one time 1 bottle, 3 times on the one.

Embodiment 17: prescription: Semen Plantaginis 1350g, Rhizoma Smilacis Glabrae 900g, Pheretima 900g, Caulis Lonicerae 900g, Radix Clematidis 900g, Radix Stephaniae Tetrandrae 900g, Pseudobulbus Cremastrae Seu Pleiones 540g.

Method for making: get above seven flavor medicine material, 8 times of decoctings that add the total amount of writing out a prescription boil 2 times, decoct 1 hour at every turn, and standing over night is got supernatant and filtered, and merging filtrate, being evaporated to relative density is 1.20(20 ℃) clear paste, spray drying, fine powder is standby; Add in the fused polyethylene glycol 6000, stir evenly, splash in the methyl-silicone oil, take out, drop pill is absorbed condensed fluid, and drying is made 20000, promptly gets drop pill of the present invention.

Specification: every heavy 40mg.

Usage: oral, one time 10,3 times on the one.

Embodiment 18: prescription: Semen Plantaginis 10544g, Rhizoma Smilacis Glabrae 3834g, Pheretima 3834g, Caulis Lonicerae 3834g, Radix Clematidis 3834g, Radix Stephaniae Tetrandrae 3834g, Pseudobulbus Cremastrae Seu Pleiones 2237g.

Method for making: get above seven flavor medicine material, 12 times of decoctings that add the total amount of writing out a prescription boil 1 time, decoct 3 hours at every turn, and standing over night is got supernatant and filtered, and merging filtrate, being evaporated to relative density is 1.25(20 ℃) clear paste, spray drying, fine powder is standby; Add in the fused polyethylene glycol 6000, stir evenly, splash in the methyl-silicone oil, take out, drop pill is absorbed condensed fluid, and drying is made 100000, promptly gets drop pill of the present invention.

Specification: every heavy 40mg.

Usage: oral, one time 10,3 times on the one.

Embodiment 19: prescription: Semen Plantaginis 450g, Rhizoma Smilacis Glabrae 300g, Pheretima 300g, Caulis Lonicerae 300g, Radix Clematidis 300g, Radix Stephaniae Tetrandrae 300g, Pseudobulbus Cremastrae Seu Pleiones 180g.

Method for making: get above seven flavor medicine material, 10 times of decoctings that add the total amount of writing out a prescription boil 2 times, decoct 3 hours at every turn, standing over night, get supernatant and filter, merging filtrate, being evaporated to relative density is 1.25(60 ℃) extractum, dry, be ground into fine powder, add right amount of auxiliary materials, grind well, be pressed into 1000, promptly get soft capsule of the present invention.

Specification: every dress 0.6g.

Usage: oral, one time 3,3 times on the one.

Embodiment 20: prescription: Semen Plantaginis 9000g, Rhizoma Smilacis Glabrae 6000g, Pheretima 6000g, Caulis Lonicerae 6000g, Radix Clematidis 6000g, Radix Stephaniae Tetrandrae 6000g, Pseudobulbus Cremastrae Seu Pleiones 3600g.

Method for making: get above seven flavor medicine material, 10 times of decoctings that add the total amount of writing out a prescription boil 2 times, decoct 3 hours at every turn, standing over night, get supernatant and filter, merging filtrate, being evaporated to relative density is 1.25(60 ℃) extractum, dry, be ground into fine powder, add right amount of auxiliary materials, grind well, be pressed into 20000, promptly get soft capsule of the present invention.

Specification: every dress 0.6g.

Usage: oral, one time 3,3 times on the one.

Embodiment 21: prescription: Semen Plantaginis 2130g, Rhizoma Smilacis Glabrae 3408g, Pheretima 3408g, Caulis Lonicerae 3408g, Radix Clematidis 3408g, Radix Stephaniae Tetrandrae 3408g, Pseudobulbus Cremastrae Seu Pleiones 2130g.

Method for making: get above seven flavor medicine material, 10 times of decoctings that add the total amount of writing out a prescription boil 3 times, decoct standing over night 1 hour at every turn, getting supernatant filters, merging filtrate, being evaporated to relative density is 1.20(20 ℃) clear paste, spray drying gets fine powder, add right amount of auxiliary materials, grind well, be pressed into 10000, promptly get soft capsule of the present invention.

Specification: every dress 0.6g.

Usage: oral, one time 3,3 times on the one.

Embodiment 22: prescription: Semen Plantaginis 7668g, Rhizoma Smilacis Glabrae 6390g, Pheretima 6390g, Caulis Lonicerae 6390g, Radix Clematidis 6390g, Radix Stephaniae Tetrandrae 6390g, Pseudobulbus Cremastrae Seu Pleiones 2982g.

Method for making: get above seven flavor medicine material, 12 times of decoctings that add the total amount of writing out a prescription boil 1 time, decoct standing over night 3 hours at every turn, getting supernatant filters, merging filtrate, being evaporated to relative density is 1.25(20 ℃) clear paste, spray drying gets fine powder, add right amount of auxiliary materials, grind well, be pressed into 20000, promptly get soft capsule of the present invention.

Specification: every dress 0.6g.

Usage: oral, one time 3,3 times on the one.

Embodiment 23: prescription: Semen Plantaginis 4500g, Rhizoma Smilacis Glabrae 3000g, Pheretima 3000g, Caulis Lonicerae 3000g, Radix Clematidis 3000g, Radix Stephaniae Tetrandrae 3000g, Pseudobulbus Cremastrae Seu Pleiones 1800g.

Method for making: get above seven flavor medicine material, 10 times of decoctings that add the total amount of writing out a prescription boil 2 times, decoct standing over night 1 hour at every turn, getting supernatant filters, merging filtrate, being evaporated to relative density is 1.25(20 ℃) extractum, spray drying gets fine powder, add right amount of auxiliary materials, grind well, be pressed into 10000, promptly get soft capsule of the present invention.

Specification: every dress 0.6g.

Usage: oral, one time 3,3 times on the one.

Embodiment 24: prescription: Semen Plantaginis 2250g, Rhizoma Smilacis Glabrae 1500g, Pheretima 1500g, Caulis Lonicerae 1500g, Radix Clematidis 1500g, Radix Stephaniae Tetrandrae 1500g, Pseudobulbus Cremastrae Seu Pleiones 900g.

Method for making: get above seven flavor medicine material, 10 times of decoctings that add the total amount of writing out a prescription boil 2 times, decoct 1 hour at every turn, standing over night is got supernatant and is filtered merging filtrate, being evaporated to relative density is 1.25(60 ℃) extractum, add ethanol and make and contain the alcohol amount and reach 60%, standing over night, get supernatant concentration to being 1.30(60 ℃ to density) extractum, drying is pulverized, sieve, add right amount of auxiliary materials, grind well, be pressed into 5000, promptly get soft capsule of the present invention.

Specification: every dress 0.45g.

Usage: oral, one time 3,3 times on the one.

Embodiments of the present invention are not limited to the foregoing description, and the various variations of making under the prerequisite that does not break away from aim of the present invention all belong within protection scope of the present invention.

Claims (5)

1. pharmaceutical preparation that prevents and treats gout, it is characterized in that it mainly is that raw medicinal material by following part by weight is prepared from: Semen Plantaginis 10%～33%, Rhizoma Smilacis Glabrae 12%～16%, Pheretima 12%～16%, Caulis Lonicerae 12%～16%, Radix Clematidis 12%～16%, Radix Stephaniae Tetrandrae 12%～16%, Pseudobulbus Cremastrae Seu Pleiones 7%～10%.

2. according to the described pharmaceutical preparation that prevents and treats gout of claim 1, it is characterized in that the part by weight of each raw material is: Semen Plantaginis 21.1%, Rhizoma Smilacis Glabrae 14.1%, Pheretima 14.1%, Caulis Lonicerae 14.1%, Radix Clematidis 14.1%, Radix Stephaniae Tetrandrae 14.1%, Pseudobulbus Cremastrae Seu Pleiones 8.4%.

3. preparation method of preventing and treating the pharmaceutical preparation of gout as claimed in claim 1 or 2, it is characterized in that, take by weighing Semen Plantaginis, Rhizoma Smilacis Glabrae, Pheretima, Caulis Lonicerae, Radix Clematidis, Radix Stephaniae Tetrandrae, Pseudobulbus Cremastrae Seu Pleiones seven flavor medicine material by recipe quantity, 6～12 times of decoctings that add the total amount of writing out a prescription boil 1～3 time, the each decoction 1～3 hour, filter, the survey relative density was 1.20～1.40 extractum when filtrate was concentrated into 20～60 ℃, and preparation process is made common clinically pharmaceutical preparation routinely then.

4. according to the described preparation method of preventing and treating the pharmaceutical preparation of gout of claim 3, it is characterized in that described pharmaceutical preparation is oral formulations or external preparation.

5. according to the described preparation method of preventing and treating the pharmaceutical preparation of gout of claim 4, it is characterized in that described oral formulations comprises decoction, granule, powder, oral liquid, syrup, soft extract, pill, tablet, hard capsule, soft capsule or drop pill.