CN102512521A - Traditional Chinese medicine composition for treating apoplexy sequela - Google Patents
Traditional Chinese medicine composition for treating apoplexy sequela Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating apoplexy sequela, wherein the traditional Chinese medicine composition comprises the following raw materials: 60-80 parts of astragalus mongholicus, 10-30 parts of salvia miltiorrhiza, 10-30 parts of radix paeoniae rubra, 10-30 parts of peach kernels, 10-30 parts of safflower carthamus, 10-30 parts of ligusticum wallichii, 10-30 parts of lumbricus and 1-10 parts of leech. The traditional Chinese medicine composition for treating apoplexy sequela disclosed by the invention is compatibly characterized in that qi-tonifying medicine and blood-activating medicine are mixed with equal amount, so that qi is vigorous and blood is circulated, blood circulation is activated without impairing vitality, and the effects of tonifying qi, activating blood circulation, removing stasis and dredging meridians are co-acted; therefore, the traditional Chinese medicine composition is a real good medicine for treating apoplexy sequela.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition of treating apoplexy sequela and preparation method thereof, belong to the modern Chinese medicine preparing technical field.
Background technology
Apoplexy is claimed apoplexy again, is on the basis of QI and blood interior-deficiency, meet the overstrain internal injury, be worried angry, have a liking for inducements such as food savoury, tobacco and wine, and then cause the internal organs imbalance of YIN and YANG, QI and blood is disorderly contrary, the criminal's of flinging brain is due to resistance of brain BI-syndrome involved the blood vessels or blood oozing from the body openings or subcuta neous tissue feeling pulse are outer.Clinical with unexpected confused servant, hemiplegia, crooked mouth and tongue, speech stuttering puckery or in silence, hemianesthesia is primary symptom, and have onset anxious, change fast, like the characteristics that ailment said due to cold or exposure benefaction number becomes, good sending out in a kind of commonly encountered diseases of middle-aged and elderly people.Apoplexy is a kind of independently disease, and the alleged cerebrovascular of its clinical manifestation and doctor trained in Western medicine is similar.Cerebrovascular mainly comprises ischemic cerebrovascular and hemorrhagic apoplexy two major types.Can be divided into acute and chronic two kinds clinically, acutely see that at most can be described as cerebrovascular accident again, apoplexy or apoplexy comprise hemorrhagic cerebral hemorrhage and subarachnoid hemorrhage, ischemic cerebral thrombosis, cerebral embolism and transient ischemic attack etc.The morbidity of chronic cerebral angiopathy is latent to be attacked, develops gradually, like cerebral arteriosclerosis, vascular dementia etc.
The generation of apoplexy, principal element are deficiency of qi and blood usually, and with the heart, liver, kidney three dirty imbalance of YIN and YANG, to be worried angry in addition, or the diet of drinking, or chamber is tired, or inducement such as exopathogen invasion and attack, so that QI-blood circulation is obstructed, and skin muscle arteries and veins loses in moistening foster; Or YIN-deficiency in the lower part, liver-yang is opened cruelly, and positive wind-transformation is moving, and bleeding resulting from adverse flow of QI is held expectorant under the arm and is held fire under the arm, and the horizontal channel tunnel of scurrying is hoodwinked key clearly, and forms excess in the upper and deficiency in the lower, the critical disease that negative and positive are not maintained mutually.Its main etiology and pathogenesis can be summed up as 1, just the deficiency of vital energy declines: worn with age, or the prolonged illness deficiency of both QI and blood, first QI consumed is hindered, and then the brain arteries and veins loses and supports.It is unable that the deficiency of vital energy is then transported blood, and thrombosis stagnates obstructed and cause the brain arteries and veins stasis of blood; Cloudy anemia is decreased, and then the moon is not made sun, YIN-deficiency in the lower part, and YANG overacting in the uppper part, positive wind-transformation is moving, and folder expectorant is turbid, disturb key clearly on the blood stasis, and pathogen is stranded in deficient brain arteries and veins and forms deficiency in the lower and excess in the upper, the burst primary disease.2, overstrain internal injury: bother excessively, be prone to make yang-energy to rise and open, priming wind sun, the endogenous wind turn, then the gas fire is all floating, or doublely holds that expectorant is turbid under the arm, stops up clear key venation on the blood stasis.Because of liver-yang is opened cruelly, to gush on the vim and vigour suddenly and apoplexy person, the state of an illness is multiple.3, eating and drinking without temperance, have a liking for food delicious food savoury, the thing that Xin Xiang scorches, or insobriety, so that taste are injured, spleen loses fortuneization, give birth in expectorant is turbid, strongly fragrant heat-transformation of a specified duration, expectorant heat is to knot, the stagnant passages through which vital energy circulates of heap soil or fertilizer over and around the roots, on cover clear key.4, five will are hindered, emotional stress: incoordination of seven emotions, the liver losing its smoothly moving state, depression of liver-QI, depression and stagnation of QI, hematogenous blockage, stasis of blood knot brain arteries and veins, the rage impairing the liver, heart-fire is contained cruelly, fire and wind stirring up each other, bleeding resulting from adverse flow of QI, on offend brain.All this kind is prone to all cause that QI and blood is contrary disorderly, on disturb the brain key and apoplexy.Expectorant is turbid: how because of dysfunction of the spleen in transportation, or liver-yang hyperactivity gram spleen, or pathogenic fire derived from stagnation of liver-QI, refining liquid becomes expectorant, and expectorant loses with the passing of time heat-transformation, and combination of phlegm and heat is stopped up the blood vessels that stagnate, on cover clear key and form apoplexy.5, blood stasis: how because of the positive deficiency of vital energy declines, deficiency of vital energy fortune blood is unable, and the blood vessels stasis of blood stagnates; Or the rage impairing the liver, extreme hyperactivity of the liver-yang, bleeding resulting from adverse flow of QI, the stasis of blood is tied in the brain arteries and veins; Or depression of liver-QI, qi depression to blood stasis, sending out is primary disease.In addition, weather cataclysm, bother excessively, feelings will swashs mutually, undue force etc. all can bring out or increase the weight of primary disease.Apoplexy has the characteristics of high incidence, high disability rate, and the main clinical manifestation of apoplexy sequela is that hemiplegia, speech are unfavorable, and about 3/4 patient can't take care of oneself, and has a strong impact on patient's quality of life.Along with the progress of China's aged tendency of population, in recent ten years, the apoplexy sickness rate has the trend that increases year by year, this means the more people with disability of appearance, brings very big burden to family and society.Therefore the treatment to apoplexy and sequela has great social significance, improves apoplexy and sequela therapeutic effect, and key is to develop that indication is wide, good effect, safe in utilization, Chinese patent medicine easily.Therefore, the development of apoplexy new drug has become one of focus of apoplexy research in recent years.
The injection of treatment apoplexy mainly is 70, a collection of preparation of the development eighties.Like Radix Salviae Miltiorrhizae Injection, ligustrazine injection and by the FUFANG DANSHEN ZHUSHEYE of wide clinical application, QINKAILING ZHUSHEYE etc.The development after the eighties of oral formulations aspect is more, like XIAOSHUAN ZAIZAO WAN, Annaowan bolus, NIAOXUEKANG KOUFUYE etc.But be used for suffering from acute stroke mostly, rare for the treatment effect and reliable curative oral drugs of apoplexy sequela.The present invention is that with inrigorating qi and promoting blood circulation, blood stasis dispelling is promoted blood circulation and is rule of treatment, is that the basisization sanction forms with the BUYANG HUANWU TANG under Chinese medical theory instructs, and the treatment of apoplexy sequela is had better curative effect with regard to present clinical effectiveness.
Summary of the invention
The purpose of this invention is to provide a kind of Chinese medicine composition of treating apoplexy sequela.
Implementation procedure of the present invention is following:
A kind of Chinese medicine composition of treating apoplexy sequela is characterized in that the raw material of this Chinese medicine composition consists of: Radix Astragali 10-100 part, Radix Salviae Miltiorrhizae 10-50 part; Radix Paeoniae Rubra 10-50 part, Semen Persicae 10-50 part, Flos Carthami 10-50 part; Rhizoma Chuanxiong 10-50 part, Pheretima 10-50 part, Hirudo 1-10 part.
Preferred proportioning is: Radix Astragali 60-80 part, Radix Salviae Miltiorrhizae 10-30 part, Radix Paeoniae Rubra 10-30 part, Semen Persicae 10-30 part, Flos Carthami 10-30 part, Rhizoma Chuanxiong 10-30 part, Pheretima 10-30 part, Hirudo 1-10 part.
The method for preparing of the Chinese medicine composition of above-mentioned treatment apoplexy sequela; May further comprise the steps: the Radix Salviae Miltiorrhizae ethanol extract reclaim ethanol concentrate the clear paste I; The residue medicinal residues and the Radix Astragali, Radix Paeoniae Rubra, Semen Persicae, Flos Carthami, Rhizoma Chuanxiong, the common decocting of Pheretima behind the Radix Salviae Miltiorrhizae ethanol extraction; Its decocting liquid precipitate with ethanol concentrate the clear paste II, clear paste I and clear paste II mixing, the Hirudo mixing after adding adjuvant and beating powder, granulate, sieve, encapsulated.
The method for preparing that the present invention treats hemiplegia sequela's Chinese medicine composition is that the physicochemical property according to the contained composition of each flavour of a drug in the prescription combines the modern pharmacological research achievement and clinical application requires, administering mode designs.The method for preparing of above-mentioned Chinese medicine composition may further comprise the steps:
(1) alcohol extraction process
Radix Salviae Miltiorrhizae adopts 6～10 times of weight 70～90% ethanol heating and refluxing extraction in 60～80 ℃ of water-baths in the compositions, reclaims ethanol, and concentrated extracting solution gets the clear paste I;
(2) extraction process by water
The Radix Astragali, Radix Paeoniae Rubra, Semen Persicae, Flos Carthami, Rhizoma Chuanxiong, Pheretima add and remain medicinal residues after 8～12 times of weight water loggings bubble added the Radix Salviae Miltiorrhizae alcohol extraction after 2 hours in the compositions, decoct 0.5～2 hour, must the water extract;
(3) process for refining
Condensed water extract to relative density 1.15～1.20 adds ethanol and makes its medicinal liquid contain the alcohol amount to reach 50～70%, and room temperature leaves standstill, filters, and reclaims ethanol, and filtrating is concentrated into relative density 1.25～1.35 under 50 ℃, the clear paste II;
(4) moulding process
Hirudo beats fine powder in the compositions, join in clear paste I and the clear paste II, three's mixing, the soluble starch that adds 2-4 times of weight stirs, granulate, dry, sieving gets final product.
Concretely, its preparation method may further comprise the steps:
(1) alcohol extraction process
Radix Salviae Miltiorrhizae adopts 8 times of amount 80% ethanol heating and refluxing extraction 2 times in 70 ℃ of water-baths in the compositions, and the 1st time 1 hour, the 2nd time 0.5 hour, reclaim ethanol, concentrated extracting solution gets the clear paste I;
(2) extraction process by water
The Radix Astragali, Radix Paeoniae Rubra, Semen Persicae, Flos Carthami, Rhizoma Chuanxiong, Pheretima add the medicinal residues 10 times of weight water logging bubbles add the Radix Salviae Miltiorrhizae alcohol extraction after 2 hours after for the first time in the compositions, decoct 1 hour, and second and third time respectively adds 8 times of water gagings, and each decocted 1 hour, got the water extract;
(3) process for refining
The water extract is concentrated into relative density 1.15～1.20 under 30 ℃, add ethanol and make its medicinal liquid contain the alcohol amount to reach 60%, and room temperature left standstill 24 hours, filtered, and reclaimed ethanol, and filtrating is concentrated into relative density 1.30 under 50 ℃, the clear paste II;
(4) moulding process
Hirudo beats fine powder in the compositions, joins in clear paste I and the clear paste II, and three's mixing afterwards with the soluble starch uniform mixing of 3 times of weight, is crossed 16 mesh sieves, granulates, and 70 ℃ of dryings are sieved, granulate, and in No. 0 capsule of packing into, every dress 0.46g.
[0011]The Radix Astragali is a pulse family herbaceos perennial Radix Astagali
Astragalus membranaceus(Fish.) Bge.
Var.monghlicus(Bge.) or Radix Astragali
Astragalus membranaceus(Fish.) dry root of Bge., property is sweet, and tepor is returned spleen, lung meridian.The Radix Astragali has invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, the effect of expelling pus and promoting granulation.Radix Astagali contains Saponin class, polysaccharide, flavonoid, aminoacid and mineral-type composition; Astramembrannin I, astramembrannin II, daucosterol, B one sitosterol, Palmic acid etc.Pharmacological research shows that astragalus decoction has blood pressure lowering, blood vessel dilating, coronary artery dilator, the thrombotic effect of minimizing.Heavy dose of Radix Astragali decocting fluid power improves cerebral edema, strengthens the nutrition of whole body state, and can bring high blood pressure down microcirculation improvement through the blood vessel dilating effect.So this experiment is adopted water liquid to decoct to the Radix Astragali and is extracted.
Radix Salviae Miltiorrhizae is the labiate Radix Salviae Miltiorrhizae
Salvia miltiorrhizaBge
.Dry root and rhizome.The property bitter, be slightly cold.GUIXIN, Liver Channel.Radix Salviae Miltiorrhizae has stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, the effect of the relieving restlessness that clears away heart-fire.The active component of Radix Salviae Miltiorrhizae is divided into fat-soluble and water solublity.Danshensu, saivianic acid A, danshensuan B, sahianic acid C, protocatechuic acid are its water soluble ingredient; Tanshinone IIA is one of fat-soluble representative composition, and relative amount is higher.Pharmacological research shows that the fat-soluble chemical constituent of Radix Salviae Miltiorrhizae has mitigation to coronary insufficiency, coronary heart disease, angina pectoris, and can improve the human body hypoxia-bearing capability; Content of Danshensu is higher in water-soluble chemical component, and pharmacological research shows the ability coronary artery dilator, and the coronary blood supply amount is increased, and myocardial ischemia and myocardial infarction are had protective effect.So this experiment to Radix Salviae Miltiorrhizae adopt behind the alcohol reflux medicinal residues again water liquid decoct extraction.
Radix Paeoniae Rubra is the ranunculaceae plant Radix Paeoniae
Paeonia lactifloraPall. or river Radix Paeoniae Rubra
Paeonia veitchiiThe dry root of Lynch.Radix Paeoniae Rubra property is bitter, is slightly cold.Return Liver Channel.Has clearing away heat and cooling blood, the effect of eliminating stasis to stop pain.Pharmacological research shows that Radix Paeoniae Rubra decocting liquid has antiplatelet aggregation and anti-thrombosis function, and can pass through blood brain barrier, the nutritional labeling of cerebral tissue is improved having a positive effect.This experiment is adopted water liquid to decoct to it and is extracted.
Semen Persicae is the rosaceous plant peach
Prunus persica(L.) Batsch or mountain peach
Prunus davidiana(Carr.) Franch
.Dry mature seed.Property is bitter, sweet, flat.GUIXIN, liver, large intestine channel.Has blood circulation promoting and blood stasis dispelling, the effect of loosening bowel to relieve constipation.The circulation of Semen Persicae decocting fluid power accelerate blood, the effect of antiplatelet aggregation.This experiment is adopted water liquid to decoct to it and is extracted.
Flos Carthami is a feverfew
Carthamus tinctoriusL. the dry tubular flower of Flos Carthami.The property hot, warm.GUIXIN, Liver Channel.Mainly contain Flos Carthami quinone glycoside, carthamin, Carthamus yellow, contain glyceric acid esters such as Palmic acid, lauric acid in Flos Carthami and the oil thereof, have the effect of promoting blood circulation to restore menstrual flow, eliminating stasis to stop pain.Pharmacological research shows that Flos Carthami decocting liquid has slight excited heart, reduces coronary resistance, coronary blood flow increasing and the effect of myocardial nutrition property blood flow; Effects such as anticoagulant, increase fibrinolysis, blood fat reducing, raising hypoxia-bearing capability, raising immunity and antiinflammatory.This experiment is adopted water liquid to decoct to it and is extracted.
Rhizoma Chuanxiong is the samphire Rhizoma Chuanxiong
Ligustium chuanxiongHort
.Dry rhizome.The property hot, warm.Return liver, gallbladder, pericardium channel.Has blood-activating and qi-promoting, the effect of wind-expelling pain-stopping.Mainly contain ligustrazine, ferulic acid, methyl phenylacetate, volatilization wet goods.Pharmacological evaluation shows that Rhizoma Chuanxiong decocting fluid power shortens thrombosis length, alleviates the dry weight and the weight in wet base of thrombosis, and coronary artery dilating increases coronary flow, reduces myocardium keto consumption; Improve pia mater encephali microcirculation and fluidised form, increase cerebrovascular pulsation blood volume.This experiment is adopted water liquid to decoct and is extracted.
Pheretima is a huge earthworm section animal Pheretima aspergillum
Pheretima aspergillum(Perrier) etc. Scorpio body.The property salty, cold.Return liver, spleen, urinary bladder channel.Have clearing heat for calming endogenous wind, collateral dredging is relievingd asthma, the effect of diuresis.Mainly contain several amino acids: ornithine, lysine, arginine etc.; Various lipids such as neutral fat, triglyceride; Other still contains deoxidation isozyme and esterification isozyme etc.Pharmacological research shows that Pheretima extract can improve blood circulation through reducing blood viscosity, anticoagulant, raising erythrocyte membrane stability and erythrocytic distortion.Water boiling and extraction is adopted in this experiment.
Hirudo is an annelid Hirudinidae Hirudo
Whitmannia pigraThe Whitman Hirudo
Hirudo nipponicaWhitman or Folium Salicis Babylonicae Hirudo
W.acranulataWhitman's is all.The property salty, bitter, flat.Slightly poisonous.Has removing blood stasis, the effect of mass dissipating and swelling eliminating.Contain a kind of H-subst in its secretions, heparin, antithrombotic element etc.The dry powder Hirudo has many pharmacological actions, like anticoagulation, antithrombotic, prevent and treat atherosclerosis, antibiotic, antitumor etc., clinically is commonly used to treat cerebrovascular, coronary heart disease, angina pectoris etc.Modern age clinical with the experiment prove that all the dry powder Hirudo is encapsulated or process finishing agent, can preserve drug effect, easy to use again.
It is empty that Chinese medicine composition of the present invention is controlled plain bromhidrosis, can not promoting the circulation of blood so that venation block, muscle arteries and veins muscle lose moisten foster, so hemiplegia, facial hemiparalysis; Blood stagnancy due to deficiency of QI, tongue body lose supports slobbering.Reuse the Radix Astragali in the side, the vigour of big tonifying the spleen and stomach makes the prosperous blood of gas capable, and the stasis of blood is removed ruton, is monarch drug.The Radix Salviae Miltiorrhizae blood vessels that can pass through, stasis-dispelling and pain-killing is specially gone into blood system, its merit is the promoting the circulation of blood of invigorating blood circulation, in reach internal organs and blood stasis dispelling stagnates, outer sharp joint and the network of promoting blood circulation is ministerial drug.Radix Paeoniae Rubra, Semen Persicae can promoting blood circulation to restore menstrual flow, stasis-dispelling and pain-killing, Rhizoma Chuanxiong can blood circulation promoting and blood stasis dispelling to promote blood circulation, again can promoting qi circulation, resolving food retention with pain relieving, the hot perfume (or spice) of Flos Carthami walks to scurry to reach extremity, blood stasis dispelling blood, but the meridian dredging is unfavorable, Pheretima is good at walking to scurry collaterals and relieving pain, is adjuvant drug.A small amount of Hirudo dispersing accumulated pathogens to resolve the mass is to be messenger drug.
We's compatibility characteristics are that Qi-tonifying drug and blood circulation promoting medicine are all measured and matched, and make the prosperous blood of gas capable, invigorate blood circulation and just do not hinder, and play the merit that tonifying QI and activating blood circulation to eliminate blood stasis is promoted blood circulation altogether, and are real in treating the good medicine of apoplexy sequela.
Description of drawings
Fig. 1 is preparation technology's flow chart of Chinese medicine composition of the present invention.
The specific embodiment
Below in conjunction with accompanying drawing the present invention is done and to describe in further detail.
(1) screening of alcohol extraction process condition
Consult the relevant bibliographical information that extracts Radix Salviae Miltiorrhizae, in order more blood circulation promoting and blood stasis dispelling antiinflammatory composition tanshinone IIA to be extracted, the inventor selects for use ethanol refluxing process that temperature, alcohol adding amount, concentration of alcohol, extraction time are investigated.Factor level is seen table 1, and alcohol extraction orthogonal test assay result sees L
9(3
4) table 2, table 3 is seen in variance analysis.
From the result of table 1-3, be the concentration of alcohol significant difference to the influence degree of tanshinone IIA.But consider big production practical situation and working condition, taking all factors into consideration optimum extraction condition is A
1B
2C
3D
3That is: Radix Salviae Miltiorrhizae adopts 8 times of amount 80% ethanol heating and refluxing extraction 2 times in 70 ℃ of water-baths in the compositions, and the 1st time 1 hour, the 2nd time 0.5 hour, reclaim ethanol, concentrated extracting solution gets the clear paste I.
(2) screening of extraction process by water condition
To influence principal element amount of water (A) that water carries, extraction time (B), extraction time (C), etc. adopt L
9(3
4) orthogonal test investigates, the astragaloside and the total extract that contain with the monarch drug Radix Astragali in the side serve as to investigate index to carry out optimal process.The investigation of soak time and water absorption be respectively 2 hours saturable, water absorption rate 160%.Experimental result is seen table 4-7.
Visible from table 4-7 data, be to investigate index with the paste-forming rate, show that by extreme difference R value size each factor effect primary and secondary is C>B>A; The results of analysis of variance shows: the C factor has significance meaning (P<0.05) with C
3B
2A
3For good; With the Astragaloside content is to investigate index, shows that by extreme difference R value size each factor effect primary and secondary is C>B>A; The results of analysis of variance shows: the C factor has significance meaning (P<0.05), with C
3B
2A
1, for good.That is: the Radix Astragali, Radix Paeoniae Rubra, Semen Persicae, Flos Carthami, Rhizoma Chuanxiong, Pheretima add 10 times of water gagings for the first time in the compositions, soak the medicinal residues after the alcohol extraction of adding Radix Salviae Miltiorrhizae after 2 hours, decoct 1 hour, and second and third time respectively adds 8 times of water gagings, and each decocted 1 hour, got the water extract.
(3) screening of process for refining condition
Extract through decocting; In the medicinal liquid except containing active ingredient; Still contain impurity such as lot of starch, protein, tannin, mix suspension grain; Preservation effective ingredient as much as possible again when removing impurity so adopt ethanol precipitation to remove impurity, is decided to be 60%, 70%, 80% through consulting at the beginning of pertinent literature contains medicinal liquid the alcohol amount.Principal element to effective component yield influence in the precipitate with ethanol process has: the temperature when relative density, the medicinal liquid of concentrated solution contain alcohol amount, precipitate with ethanol before the precipitate with ethanol etc. are index with the content of astragaloside in precipitate amount and the medicinal liquid, preferably alcohol precipitation process.The precipitate with ethanol time adopts and left standstill 24 hours through preliminary experiment.Table 8-11 is seen in concrete experiment.
8-11 can find out by table, with the precipitate is to investigate index, and the extreme difference of factor A is maximum; Can think that it is A＞B＞D＞C that each factor influences size order to precipitate with ethanol, from each factor level (K value), A and B factor are K3＞K2＞K1 again; Factor C is K1＞K3＞K2, sees that so that Astragaloside content is influenced factor B extreme difference is maximum; From each factor level (K value), B, C factor are K again
1>K
2>K
3, the A factor is K
3>K
1>K
2, according to above intuitive analysis result, its precipitate with ethanol condition should be A
3B
3C
1D
2Or A
3B
1C
1D
2
Consider actual production efficient and cost, be necessary the lower horizontal significance of factor is carried out variance analysis the square difference analysis of result table 11.The result shows that factor A has appreciable impact to disgorging, and factor B has appreciable impact to Astragaloside content, in conjunction with the orthogonal table intuitive analysis, considers precipitate with ethanol efficient and cost simultaneously, and its selection process is with A
3B
1C
1D
2Be advisable, that is: the water extract is concentrated into relative density 1.15～1.20 under 30 ℃, adds ethanol and makes its medicinal liquid contain the alcohol amount to reach 60%, and room temperature left standstill 24 hours, filtered, and reclaimed ethanol, and filtrating is concentrated into relative density 1.30 under 50 ℃, the clear paste II.
(4) screening of molding technological condition
According to the clear paste that above-mentioned preferred alcohol extraction, water are carried, process for refining makes three parts of these Chinese medicine compositions; Add the Hirudo fine powder, (soluble starch: microcrystalline Cellulose CMC: steviosin=96:3.5:0.5) be the adjuvant granulation, and supplementary product consumption is clear paste: adjuvant=1:3 with dextrin, soluble starch, mixed accessories respectively; Pour into thick paste in the adjuvant while hot; Mix thoroughly, cross 16 mesh sieves, granulate.According to the practical situation of soft material, add an amount of ethanol and mix and stir, or carry out 2 times and granulate, drying, granulate sieves.
Investigation to mobility of particle: adopt the fixed funnel method; With the series connection of 3 funnels and be fixed in 1cm place on the graph paper of horizontal positioned, next funnel goes out flatly, will be that I, II, the III medicated powder that adjuvant makes is poured in the bell mouth of going up most along hopper walls with dextrin, starch, lactose respectively carefully; Till the medicated powder cone tip that forms on the graph paper touches funnel; By the diameter (measuring repeatedly 5 times) of graph paper survey cone base, calculate angle of repose: tg α=H/R, the result sees table 12.
Visible by last table, extract powder angle of repose of three kinds of adjuvant preparations, flowability was not good all greater than 40 °, but with the dried cream powder II of mixed accessories preparation, was significantly less than two kinds of methods in addition its angle of repose, and near 40 °.Mensuration to the granule hydroscopicity: the glass exsiccator that the bottom is filled the sodium chloride supersaturated solution is put into 25 ℃ constant incubator constant temperature 24h; This moment, the relative humidity in the exsiccator was 75.28%, put 4g medicated powder in the weighing botle bottom of constant weight, accurate claim fixed; Place the glass exsiccator interior (the weighing bottle cap is opened) of sodium chloride supersaturated solution; Preserve in 25 ℃ of constant incubators, the moisture absorption percentage rate is calculated in regularly weighing.Medicated powder weight after hydroscopicity (%)=moisture absorption-moisture absorption prodrug grain weight amount/moisture absorption prodrug grain weight amount * 100% (every kind method parallel 3 parts), the result sees table 13.
Visible by table 12, table 13, hydroscopicity is minimum with the dried cream powder II, and hydroscopicity is merely 4.23% in 8 hours, and is brown with the granule of this test technology preparation, and little sweet, outward appearance is even.So confirm that (soluble starch: microcrystalline Cellulose CMC: steviosin=96:3.5:0.5) is its best adjuvant to this mixed accessories.Hirudo beats fine powder in the compositions, joins in clear paste I and the clear paste II three's mixing; Afterwards with the mixed accessories of 3 times of amounts (soluble starch: microcrystalline Cellulose CMC: steviosin=96:3.5:0.5) uniform mixing, sieve, granulate; Drying, granulate incapsulates.
Compare with existing Chinese medicine composition of treating apoplexy sequela and preparation method thereof, the present invention has following innovative point:
1, our compatibility characteristics are: reuse the Radix Astragali in the side, the vigour of big tonifying the spleen and stomach makes the prosperous blood of gas capable, and the stasis of blood is removed ruton, is monarch drug.The Radix Salviae Miltiorrhizae blood vessels that can pass through, stasis-dispelling and pain-killing is specially gone into blood system, its merit is the promoting the circulation of blood of invigorating blood circulation, in reach internal organs and blood stasis dispelling stagnates, outer sharp joint and the network of promoting blood circulation is ministerial drug.Radix Paeoniae Rubra, Semen Persicae can promoting blood circulation to restore menstrual flow, stasis-dispelling and pain-killing, Rhizoma Chuanxiong can blood circulation promoting and blood stasis dispelling to promote blood circulation, again can promoting qi circulation, resolving food retention with pain relieving, the hot perfume (or spice) of Flos Carthami walks to scurry to reach extremity, blood stasis dispelling blood, but the meridian dredging is unfavorable, Pheretima is good at walking to scurry collaterals and relieving pain, is adjuvant drug.A small amount of Hirudo dispersing accumulated pathogens to resolve the mass is to be messenger drug.Qi-tonifying drug and blood circulation promoting medicine are all measured and are matched in 8 kinds of Chinese medicine compositions, make the prosperous blood of gas capable, invigorate blood circulation and just do not hinder, and play the merit that tonifying QI and activating blood circulation to eliminate blood stasis is promoted blood circulation altogether, real good medicine for treatment apoplexy and sequela thereof.
2, the method for preparing of the Chinese medicine composition of this treatment apoplexy is that physicochemical property according to the contained composition of each flavour of a drug in the prescription combines the modern pharmacological research achievement and clinical application requires, administering mode designs, and confirm through rigorous and complete experiment condition screening.Concrete preparation technology is following:
Radix Salviae Miltiorrhizae adopts 8 times of amount 80% ethanol heating and refluxing extraction 2 times in 70 ℃ of water-baths in the compositions, the 1st time 1 hour, the 2nd time 0.5 hour, reclaim ethanol, concentrate the clear paste I; The Radix Astragali, Radix Paeoniae Rubra, Semen Persicae, Flos Carthami, Rhizoma Chuanxiong, Pheretima add 10 times of water gagings for the first time in the compositions, soak the medicinal residues after the alcohol extraction of adding Radix Salviae Miltiorrhizae after 2 hours, decoct 1 hour, and second and third time respectively adds 8 times of water gagings, and each decocted 1 hour, got the water extract; The water extract is concentrated into relative density 1.15～1.20 under 30 ℃, add ethanol and make its medicinal liquid contain the alcohol amount to reach 60%, and room temperature left standstill 24 hours, filtered, and reclaimed ethanol, and filtrating is concentrated into relative density 1.30 under 50 ℃, the clear paste II.Hirudo beats fine powder in the compositions, joins in clear paste I and the clear paste II, and three's mixing with the soluble starch uniform mixing of 3 times of amounts, sieves afterwards, granulate, and drying, granulate incapsulates.
Clinical data
All case is all from the hospital of traditional Chinese hospital, Shangluo City in May, 2006～2010 year outpatient service in May and inpatient, totally 90 examples.Be divided into treatment group and matched group at random, all continuous use is 2 months.44 examples are organized in treatment, male 24 examples, women 20 examples, 38～79 years old age, average 60.2 years old; Matched group 46 examples, male 20 examples, women 26 examples, 40～82 years old age, average 62.1 years old.2 groups of data are through statistical procedures, and difference does not have significance (P>0.05), has comparability.All case all meets the diagnostic criteria of the 4th the cerebrovascular academic conference in the whole nation.And confirm through head CT.
Diagnostic criteria
" diagnostic points of all kinds of cerebrovascular disease " of the 4th national cerebrovascular academic conference revision of diagnosis basis nineteen ninety-five Chinese Medical Association; " the apoplexy diagnosis efficacy assessment standard " that Chinese medical discrimination is worked out according to State Administration of Traditional Chinese Medicine's encephalopathy emergency case cooperative groups, all case is syndrome of blood stasis due to qi deficiency.
1, Therapeutic Method
Adopt the random packet method to divide into groups: 2 groups of patients all accept to fall conventional therapies such as cranium pressure, blood pressure lowering, blood sugar lowering, infection, nourishing brain cell, microcirculation improvement.The treatment group adopts Chinese medicine composition of the present invention on the basis of conventional therapy: Radix Astragali 70g, Radix Salviae Miltiorrhizae 20g Radix Paeoniae Rubra 10g; Semen Persicae 10g, Flos Carthami 10g, Rhizoma Chuanxiong 10g; Pheretima 10g, Hirudo 1g processes capsule according to extraction process by water, alcohol extraction process, process for refining, moulding process among the present invention.Oral, one time 4～5, three times on the one.4 weeks were 1 course of treatment.
2, therapeutic outcome
2.1 criterion of therapeutical effect: the primary symptoms such as mind, speech, limb motion to patient before and after the treatment are carried out Comprehensive Assessment, with reference to nineteen ninety-five Chinese Medical Association's efficacy assessment standard that the 4th time the cerebrovascular academic conference is passed through.Be almost recovered: the functional impairment scoring reduces 91%～100%; Marked improvement: the functional impairment scoring reduces 46%～90%; Progressive: the functional impairment scoring reduces 18%～45%; No change: the functional impairment scoring reduces about 17%; Worsen: the functional impairment scoring reduces or increases more than 18%, or dead.
2.2 therapeutic outcome: see table 14, table 15.
Conclusion
The brain jam position is at brain, and pathogenesis belongs to deficiency in origin and excess in superficiality, and promptly blood stasis due to qi deficiency runs through the course of disease all the time.Chinese medicine composition among the present invention is the rule of treatment with the benefiting QI for activating blood circulation disperse blood stasis and dredge collateral; The Radix Astragali is a monarch drug in the side; Effect with tonifying Qi and lifting yang consolidating superficial resistance, contained polysaccharide has enhancing human body immunity power, promotes organism metabolism; Improve cAMP, IgM, IgE level in the human blood, obviously reduce thrombosis and reduce platelet adhesion rate.Platelet aggregation there is obvious inhibitory action, also has effects such as arteriosclerosis, blood fat reducing, defying age, calmness; The Radix Salviae Miltiorrhizae and the Radix Astragali share, and make the handsome blood of gas capable, help that blood stasis is dispelled, the brain ruton.Contained TANSHINONES ability microcirculation improvement promotes the opening of collateral circulation, and antiplatelet aggregation improves anoxia endurance; Radix Paeoniae Rubra, Semen Persicae ability promoting blood circulation to restore menstrual flow, stasis-dispelling and pain-killing, both all have antiplatelet aggregation and anti-thrombosis function by decocting liquid, and can pass through blood brain barrier, the nutritional labeling of cerebral tissue are improved having a positive effect; Flos Carthami, Rhizoma Chuanxiong all have blood-activating and qi-promoting, the merit of dispelling wind and removing obstruction in the collateral, and its active chemical carthamone of modern pharmacological research proof, saffloside, ligustrazine be the ability expansion of cerebral vascular all; Reduce vascular resistance; Anticoagulant reduces WBV, the formation of prevention thrombosis; Hirudo, Pheretima are insect medicine, and property is apt to away scurry, and have the merit of removing blood stasis collateral dredging, promptly " dispel the wind and search network ".Slightly poisonous because of Hirudo, so consumption 1g only, Hirudo extract hirudin, antithrombotic have stronger anticoagulant, the atheromatous plaque that disappears, expansion capillary action.Lumbricin has anticoagulant and fibrinolytic effect.The compatibility characteristics of the Chinese medicine composition among the present invention are that Qi-tonifying drug and blood circulation promoting medicine are all measured and matched, and make the prosperous blood of gas capable, invigorate blood circulation and just do not hinder.Through anticoagulant, thrombolytic, anti peroxidation of lipid, improve effects such as hemorheology, cerebral blood flow increasing amount blood stasis absorb to be dissipated, promote that brain function further recovers, compare (P < 0.01) evident in efficacy with matched group.Therefore, on the basis of conventional therapy, cooperate the Chinese medicine composition among the present invention can reach the purpose that improves treatment apoplexy curative effect.
Claims (6)
1. a Chinese medicine composition of treating apoplexy sequela is characterized in that the raw material of this Chinese medicine composition consists of: Radix Astragali 10-100 part, Radix Salviae Miltiorrhizae 10-50 part; Radix Paeoniae Rubra 10-50 part, Semen Persicae 10-50 part, Flos Carthami 10-50 part; Rhizoma Chuanxiong 10-50 part, Pheretima 10-50 part, Hirudo 1-10 part.
2. the Chinese medicine composition of treatment apoplexy sequela according to claim 1 is characterized in that the raw material of this Chinese medicine composition consists of: Radix Astragali 60-80 part, Radix Salviae Miltiorrhizae 10-30 part; Radix Paeoniae Rubra 10-30 part; Semen Persicae 10-30 part, Flos Carthami 10-30 part, Rhizoma Chuanxiong 10-30 part; Pheretima 10-30 part, Hirudo 1-10 part.
3. the method for preparing of the Chinese medicine composition of the said treatment apoplexy sequela of claim 1; It is characterized in that: the Radix Salviae Miltiorrhizae ethanol extract reclaim ethanol concentrate the clear paste I; The residue medicinal residues and the Radix Astragali, Radix Paeoniae Rubra, Semen Persicae, Flos Carthami, Rhizoma Chuanxiong, the common decocting of Pheretima behind the Radix Salviae Miltiorrhizae ethanol extraction; Its decocting liquid precipitate with ethanol concentrate the clear paste II, clear paste I and clear paste II mixing, the Hirudo mixing after adding adjuvant and beating powder, granulate, sieve, encapsulated.
4. the method for preparing of the Chinese medicine composition of treatment apoplexy sequela according to claim 3 is characterized in that may further comprise the steps:
(1) alcohol extraction process
Radix Salviae Miltiorrhizae adopts 6～10 times of weight 70～90% ethanol heating and refluxing extraction in 60～80 ℃ of water-baths in the compositions, reclaims ethanol, and concentrated extracting solution gets the clear paste I;
(2) extraction process by water
The Radix Astragali, Radix Paeoniae Rubra, Semen Persicae, Flos Carthami, Rhizoma Chuanxiong, Pheretima add and remain medicinal residues after 8～12 times of weight water loggings bubble added the Radix Salviae Miltiorrhizae alcohol extraction after 2 hours in the compositions, decoct 0.5～2 hour, must the water extract;
(3) process for refining
Condensed water extract to relative density 1.15～1.20 adds ethanol and makes its medicinal liquid contain the alcohol amount to reach 50～70%, and room temperature leaves standstill, filters, and reclaims ethanol, and filtrating is concentrated into relative density 1.25～1.35 under 50 ℃, the clear paste II;
(4) moulding process
Hirudo beats fine powder, join in clear paste I and the clear paste II, three's mixing, the soluble starch that adds 2-4 times of weight stirs, granulate, dry, sieving gets final product.
5. the method for preparing of the Chinese medicine composition of treatment apoplexy sequela according to claim 4 is characterized in that may further comprise the steps:
(1) alcohol extraction process
Radix Salviae Miltiorrhizae adopts 8 times of weight 80% ethanol heating and refluxing extraction 2 times in 70 ℃ of water-baths in the compositions, and the 1st time 1 hour, the 2nd time 0.5 hour, reclaim ethanol, concentrated extracting solution gets the clear paste I;
(2) extraction process by water
The Radix Astragali, Radix Paeoniae Rubra, Semen Persicae, Flos Carthami, Rhizoma Chuanxiong, Pheretima add the medicinal residues 10 times of weight water logging bubbles add the Radix Salviae Miltiorrhizae alcohol extraction after 2 hours after for the first time in the compositions, decoct 1 hour, and second and third time respectively adds 8 times of weight water, and each decocted 1 hour, got the water extract;
(3) process for refining
The water extract is concentrated into relative density 1.15～1.20 under 30 ℃, add ethanol and make its medicinal liquid contain the alcohol amount to reach 60%, and room temperature left standstill 24 hours, filtered, and reclaimed ethanol, and filtrating is concentrated into relative density 1.30 under 50 ℃, the clear paste II;
(4) moulding process
Hirudo beats fine powder, joins in clear paste I and the clear paste II, and three's mixing afterwards with the soluble starch uniform mixing of 3 times of weight, is crossed 16 mesh sieves, granulates, and 70 ℃ of dryings are sieved, granulate, and in No. 0 capsule of packing into, every dress 0.46g.
6. the application of the described Chinese medicine composition of claim 1 in preparation treatment apoplexy sequela medicine.
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