CN101391081A - Medicine composition for treating qi and blood derangement of essential hypertension and preparation method thereof - Google Patents

Abstract

The invention relates to a medicine composite for treating derangement of qi and blood caused by essential hypertension, which comprises the following raw medicines: caltrop, cortex moutan, rhizome ligustici chuanxiong, cirsium japonicum, rhizome wenyujia concise, loranthus parasiticus and herba siegesbeckiae. The medicine composite is suitable for treating derangement of qi and blood caused by essential hypertension with the syndromes such as headache, fullness of the head, dim and red complexion, frequent hot, compression feeling on chest or twinge in chest, occasional cardio palmus, csurrying pain or numbness in limbs, women menoxenia, dry mouth, thin tongue coating, deep red tongue or purple plague or petechia on tongue and wiry or uneven pulse. The invention has the efficacies in promoting blood circulation for removing blood stasis, peripheral vasodilatation and decreasing blood pressure, has few medicinal ingredients and special drug, potency, is safe and effective, and can be made into various oral preparations.

Description

A kind of pharmaceutical composition for the treatment of qi and blood derangement of essential hypertension and preparation method thereof

Technical field

The present invention relates to pharmaceutical composition of a kind of treatment qi and blood derangement of essential hypertension that comes from Chinese medicine and preparation method thereof.

Background technology

Hypertension is that to increase with arteriotony be the disease of main clinical manifestation, belongs to the category of diseases such as the traditional Chinese medical science is dizzy, headache, is modal clinically frequently-occurring disease, the important risk factor of cardiovascular and cerebrovascular disease.The morbidity and the hypertension of cardiovascular and cerebrovascular disease have confidential relation, so its harm is very big.

The cause of disease of primary disease is many by disorder of emotion, eating and drinking without temperance, and the deficient grade of internal injury causes the body imbalance between YIN and YANG, QI and blood abnormal ascending-descending of QI, blood-vessel obstructive and falling ill.As long-term psychentonia or angry troubled thoughts, strongly fragrant in the irritability, the liver failing to maintain the normal flow of QI, is given birth to expectorant at strongly fragrant fire-transformation of a specified duration, wind symptom, on disturb clearly key and be headache, dizzy; Or surfeit delicious food savoury, or insobriety so that expectorant is given birth in turbid, accumulates heat-transformation of a specified duration, expectorant is given birth in the Tianjin of burning, the turbid obstruction venation of expectorant, on disturb clearly key and cause headache, dizzy; Or impairment caused by overstrain is excessive, or the plain body deficiency of YIN, the vital essence internal injury, and liver is lost and to moisten fosterly, or deficiency of kidney-YIN is disturbed clearly key and is caused headache, dizzy on the wind-fire.Total genus yang hyperactivity and deficiency of YIN reciprocal causation.Obstinate disease can cause deficiency of YIN affecting YANG, deficiency of both YIN and YANG, and the internal organs imbalance between YIN and YANG will inevitably cause that QI-blood circulation is not normal, and the stagnation of QI network stasis of blood, gas lift blood is contrary.Point out when discussing apoplexy as " the complete works of good recipe of my humble opinion ": " all because of yang imbalance, abnormal functional activities of ZANG FUorgans, Rong Wei mistake degree, QI and blood entanglement ".The pathologic basis that prompting hypertension is developed to apoplexy is a disorder of QI and blood.Thereby be the disorder of QI and blood card of hypertension, use regulating QI and blood method, theoretical foundation is provided.QI and blood is smooth and easy, and passages through which vital energy circulates is sensible, YIN and YANG balancing then, blood pressure self-balancing.

The traditional Chinese medical science mostly is due to the hyperactivity of YANG due to deficiency of YIN the understanding of hypertension.The deficiency of YIN is based on Liver and kidney (heart) deficiency of YIN, and then main liver (heart) sun of yang hyperactivity is high partially, thus fire-transformation, living expectorant, with the passing of time deficiency of YIN affecting YANG, deficiency of both YIN and YANG.Curing house modern age also has the blood of thinking meridians pathological changes, the imbalance of QI and blood as one of hypertensive basic pathology, as open stannum blunt think change to exist connecting each other between these pathology due to the hypertension system " QI and blood upper punch ", and reciprocal causation." have all in the person, must shape all outer ", the physiological function imbalance of inside of human body must reflect various clinical manifestations.Because the internal organs imbalance of YIN and YANG can cause the QI-blood circulation imbalance, mainly show as contrary and two aspects of qi depression to blood stasis of gas lift blood.Because of excessive rising of liver-YANG, the fire-transformation wind symptom, the impulse QI and blood then shows the contrary symptom of gas lift blood, as headache, feeling of fullness in the head or head jumping pain, a muscle jump up, flushed face with fever sensation, conjunctival congestion etc.If delay endlessly, disease is gone into network for a long time; Or, lose in thin sharp, or hold the expectorant stasis of blood under the arm because of liver-wind and hinder meridians because of irritability stasis; Or because of QI and blood declines fewly, it is uncomfortable operate, all can cause qi depression to blood stasis, and sees headache as thorn, numb limbs and tense tendons, and color is dim red, even obstruction of qi in the chest and cardialgia, tongue is seen purple gas ecchymosis, thready and hesitant pulse knot generation etc. disease.Though disorder of QI and blood is by due to the internal organs imbalance of YIN and YANG, but can increase the weight of the unbalance of internal organs negative and positive, make negative and positive partially more very, the function of the five internal organs is taken advantage of separated, and is said as " element is asked the regulating menstruation opinion ": " road of the five internal organs is all for channel tunnel; with promoting the circulation of blood gas, and vim and vigour discord, all kinds of diseases and ailments are to become and give birth to ".This shows, the internal organs imbalance between YIN and YANG, but with the disorder of QI and blood reciprocal causation, promote the evolving development of hypertension thus.Adopt regulating QI and the treatment of blood method also to appear in the newspapers repeatly at the pathological change of hypertension disorder of QI and blood.

CN01107092.7 is the pharmaceutical composition that is used for the treatment of osteoporosis, extract with natural medicinal raw material Fructus Psoraleae, Radix Achyranthis Bidentatae and Herba Epimedii is effective medicinal ingredient, become to be grouped into the auxiliary interpolation that allows in the pharmacy to use, each active drug extracts the weight that used raw material crude drug weight represents and consists of to be equivalent to it with the component extract: Fructus Psoraleae 1, Radix Achyranthis Bidentatae 2-20, Herba Epimedii 2-20, auxiliary interpolation property composition 0-3.CN200810084247.0 is the hypertensive Chinese medicine of a kind of treatment, for the problem that solves prior art therapeutic effect difference is invented.It is made up of following raw material: Rhizoma Atractylodis Macrocephalae 15g, Radix Glycyrrhizae 25g, Rhizoma Et Radix Notopterygii 25g, Radix Saposhnikoviae 20g, Radix Angelicae Sinensis 20g, Cortex Magnoliae Officinalis 6g, Radix Bupleuri 25g, Rhizoma Chuanxiong 15g, Radix Astragali 20g, Rhizoma Atractylodis 6g, Gypsum Fibrosum 10g, Rhizoma Pinelliae 5g, Arisaema Cum Bile 6g, Pericarpium Citri Reticulatae Viride 10g, Fructus Forsythiae 20g, Semen Cassiae 10g, Herba Equiseti Hiemalis 20g, Fructus Tribuli 20g, Squama Manis 5g, Radix Achyranthis Bidentatae 10g, Spica Prunellae 15g, pollen 15g, Semen Raphani 10g, Massa Medicata Fermentata 10g, Rhizoma Cimicifugae 15g, Radix Et Rhizoma Rhei 10g, Herba Schizonepetae 15g.We have the expectorant collateral dredging, weed out the old and bring forth the new, and the effect of liver-smoothing, qi-regulating can be discharged enteral impurity or poisonous impurity, makes blood pressure normal, thereby moves towards healthy life.CN200810025784.8 is the hypertensive Chinese herbal medicine of a kind of treatment, and it is made by following bulk drugs: 6～10 parts of 8～12 parts of Radix Puerariaes, 10～14 parts of Radix Salviae Miltiorrhizaes, 4～8 parts of Rhizoma Chuanxiongs, 4～8 parts of Cortex Phellodendris, 10～14 parts of Herba Taxillis, 3～7 parts of Elephantopus scaber L., 13～17 parts of Ramulus Uncariae Cum Uncis, 8～12 parts of the Cortexs Eucommiae and Fructus Atriplicis Sibiricaees.The effect of each crude drug of the present invention plays synergism, and vasoactive is repaired the outmoded blood vessel wall of damaging rapidly, recovers blood vessel elasticity, improves arteriosclerosis, regulates function of human body comprehensively, thereby can prevent and treat hypertension.CN200410040124.9 is the hypertensive Chinese medicine of a kind of treatment; it is by Herba Artemisiae Scopariae; Fructus Trichosanthis; Fructus Crataegi; Flos Chrysanthemi Indici; Ramulus Uncariae Cum Uncis; Semen Cassiae; Fructus Atriplicis Sibiricae; Herba Leonuri; Rhizoma Curcumae Longae; Pollen Typhae; Flos Musae; the Radix Astragali; Rhizoma Chuanxiong; the Radix Polygoni Multiflori; Herba Taxilli; the Cortex Eucommiae; the Radix Paeoniae Alba; Radix Achyranthis Bidentatae Herba Siegesbeckiae; Caulis Piperis Kadsurae; Pheretima; Semen Raphani; Herba Plantaginis; Folium Ginkgo; ground beetle; Radix Notoginseng; Flos Chrysanthemi is formulated; the present invention is with blood pressure lowering; the factor of clearing; the protection internal organs are Trinitarian Comprehensive Treatment; main dampness removing reduces phlegm; promoting flow of QI and blood; nourishing YIN for suppressing the hyperactive YANG; mend the Liver and kidney that overflows; treatment of arthritis and promoting collateral and channels; to treatment hypertension; has lowering and stabilizing blood pressure; improve blood viscosity, the effect of microcirculation improvement flow.CN200310121005.1 is a kind of medicine and preparation method for the treatment of essential hypertension, based on motherland's medical science to treating hyperpietic understanding and Therapeutic Principle, the medicament of making by the following weight parts proportioning: RADIX PUERARIAE 10-20, Ramulus Uncariae macrophyllae 10-20, Spica Prunellae 10-20, Radix Gentianae Macrophyllae 10-20, Pheretima 8-16, capillary wormwood 10-20, and Fructus Tribuli 8-16, Radix Scutellariae 8-16, car Radix Saposhnikoviae 8-16, treat Herba Asari 2-10, Rhizoma Et Radix Notopterygii 6-12, Radix Rehmanniae 6-12, at least a among the Rhizoma Atractylodis 10-20, the present invention treats the medicine effective percentage 100% of essential hypertension, cure rate 93%.

Summary of the invention

The technical problem to be solved in the present invention is a kind of pharmaceutical composition to the qi and blood derangement of essential hypertension treating both the principal and secondary aspects of a disease of research, with regulating QI and blood, performance blood circulation promoting and blood stasis dispelling, the merit of expanding peripheral vessels, bringing high blood pressure down, and flavour of a drug are few and the efficacy of a drug is special, and toxic and side effects is littler, safe and effective than chemical medicine.But the present invention also comprises the preparation method of described pharmaceutical composition commercial Application.

The invention provides following technical proposals for addressing the above problem.

A kind of pharmaceutical composition for the treatment of qi and blood derangement of essential hypertension is characterized in that being made by the following raw materials in part by weight medicine basically: Fructus Tribuli 7-13 part, Cortex Moutan 6-12 part, Rhizoma Chuanxiong 7-13 part, Radix Cirsii Japonici 9-15 part, Rhizoma Wenyujin Concisum 6-12 part, Herba Taxilli 9-15 Fen, Herba Siegesbeckiae 7-13 part.

Described preparation of drug combination method comprises the following steps:

A) take by weighing each crude drug Fructus Tribuli, Cortex Moutan, Rhizoma Chuanxiong, Radix Cirsii Japonici, Rhizoma Wenyujin Concisum, Herba Taxilli, Herba Siegesbeckiae, standby;

B) the crude drug Cortex Moutan is ground into coarse powder, adds the water distillation, collect distillate, other device of water solution A is deposited standby, and the distillate deepfreeze filters, and gets the paeonol crystallization, with β-CD inclusion, filters, and gets inclusion complex, and drying is ground into fine powder B, and is standby;

C) crude drug Rhizoma Chuanxiong, Rhizoma Wenyujin Concisum two flavors are added the water distillation, extract volatile oil, other device of the aqueous solution C after the distillation is deposited standby, and medicinal residues are used alcohol reflux together with the crude drug Fructus Tribuli, and the extracting solution decompression recycling ethanol also is concentrated into into clear paste D, places standby; Volatile oil filters with β-CD inclusion, gets inclusion complex, and drying is ground into fine powder E, and is standby;

D) crude drug Radix Cirsii Japonici, Herba Taxilli, Herba Siegesbeckiae are decocted with water together with the medicinal residues of Cortex Moutan, decoction liquor leaves standstill, the leaching supernatant, the supernatant that adds the step b) water solution A, the supernatant of step c) aqueous solution C, it is an amount of to add ethanol behind the concentrating under reduced pressure, leave standstill, get supernatant, filter, decompression filtrate recycling ethanol also is condensed into clear paste F, add step c) clear paste D, abundant mixing, drying under reduced pressure, pulverize, get clear paste dry powder G;

E) clear paste dry powder G adds step b) fine powder B, step c) fine powder E and appropriate amount of auxiliary materials, abundant mixing, the active component of pharmaceutical composition of the present invention.

Preferred pharmaceutical composition, the consumption of its crude drug is counted by weight: Fructus Tribuli 9-11 part, Cortex Moutan 8-10 part, Rhizoma Chuanxiong 9-11 part, Radix Cirsii Japonici 11-13 part, Rhizoma Wenyujin Concisum 8-10 part, Herba Taxilli 11-13 part, Herba Siegesbeckiae 9-11 part.

Most preferred pharmaceutical composition, wherein the consumption of crude drug is counted by weight: 10 parts of Fructus Tribulis, 9 parts of Cortex Moutans, 10 parts of Rhizoma Chuanxiongs, 12 parts of Radix Cirsii Japonicis, 9 parts of Rhizoma Wenyujin Concisum, 12 parts of Herba Taxillis, 10 parts of Herba Siegesbeckiaes.

Pharmaceutical composition of the present invention contains pharmaceutically acceptable oral formulations adjuvant.

In the preferred manufacturing procedure step b) is ground into coarse powder with the crude drug Cortex Moutan, adds the water distillation, collect 8-10 and doubly measure distillate, other device of water solution A is deposited standby, and distillate low temperature (5～8 ℃) cold preservation is spent the night, and filters, the paeonol crystallization, dry (40～45 ℃), add the small amount of ethanol dissolving after, with β-CD that 7-9 doubly measures, inclusion, low temperature (5～8 ℃) cold preservation is spent the night, filter, get inclusion complex, drying is ground into fine powder B; Step c) Rhizoma Chuanxiong, Rhizoma Wenyujin Concisum two flavors add the water distillation, extracted volatile oil 3-5 hour, aqueous solution C after distillation device in addition deposits standby, medicinal residues are used 65%-75% alcohol reflux 2 times together with the crude drug Fructus Tribuli, add 8-12 at every turn and doubly measure ethanol, extracting solution decompression recycling ethanol and to be condensed into relative density be 1.10～1.25 (95～100 ℃ of surveys) clear paste D, place standby, β-CD that volatile oil is doubly measured with 7-9, inclusion, low temperature (5～8 ℃) cold preservation is spent the night, filter, get inclusion complex, drying is ground into fine powder E; The step d) Radix Cirsii Japonici, Herba Taxilli Herba Siegesbeckiae decocts with water secondary together with the medicinal residues of Cortex Moutan, decoction liquor left standstill 24 hours, the leaching supernatant, the supernatant that adds the step b) water solution A, the supernatant of step c) aqueous solution C, being evaporated to relative density is 1.10～1.25 (95～100 ℃ of surveys), adding ethanol transfers and to contain alcohol and measure to 65%-75%, left standstill 24 hours, and got supernatant, filter, decompression filtrate recycling ethanol also is concentrated into the clear paste F that relative density is 1.10～1.25 (95～100 ℃ of surveys), add step c) clear paste D, abundant mixing, drying under reduced pressure, pulverize, get clear paste dry powder G; Step e) gets fine powder F with fluid extract E spray drying; E) clear paste dry powder G is added step b) fine powder B, step c) fine powder E and an amount of dextrin, fully mixing.

In the preferred preparation method step b) is ground into coarse powder with the crude drug Cortex Moutan, adds the water distillation, collect 9 times of amount distillates, other device of water solution A is deposited standby, and distillate low temperature (5～8 ℃) cold preservation is spent the night, and filters, the paeonol crystallization, dry (40～45 ℃), add the small amount of ethanol dissolving after, with the β-CD of 8 times of amounts, 80 times of water gagings stirred inclusion 1 hour under 50 ℃ of conditions, low temperature (5～8 ℃) cold preservation is spent the night, and filters, and gets inclusion complex, 45 ℃ of dryings of inclusion complex are ground into fine powder B; Step c) Rhizoma Chuanxiong, Rhizoma Wenyujin Concisum two flavors add the water distillation, extracted volatile oil 4 hours, aqueous solution C after distillation device in addition deposits standby, medicinal residues together with the crude drug Fructus Tribuli with 70% alcohol reflux 2 times, add 10 times of amount ethanol at every turn, extracting solution decompression recycling ethanol and to be condensed into relative density be 1.15～1.20 (95～100 ℃ of surveys) clear paste D, place standbyly, volatile oil is with the β-CD of 8 times of amounts, 80 times of water gagings, under 30 ℃ of conditions, stirred inclusion 1 hour, low temperature (5～8 ℃) cold preservation is spent the night, and filters, and gets inclusion complex, 50 ℃ of dryings of inclusion complex are ground into fine powder E; The step d) Radix Cirsii Japonici, Herba Taxilli Herba Siegesbeckiae decocts with water secondary together with the medicinal residues of Cortex Moutan, each 2 hours, merge decoction liquor, decoction liquor left standstill 24 hours, the leaching supernatant, the supernatant of adding step b) water solution A, the supernatant of step c) aqueous solution C, being evaporated to relative density is 1.15～1.20 (95～100 ℃ of surveys), add the ethanol accent and contain the alcohol amount to 70%, left standstill 24 hours, and got supernatant, filter, decompression filtrate recycling ethanol also is concentrated into the clear paste F that relative density is 1.15～1.20 (95～100 ℃ of surveys), add step c) clear paste D, abundant mixing, drying under reduced pressure, pulverize, get clear paste dry powder G; Step e) gets fine powder F with fluid extract E spray drying; E) clear paste dry powder G is added step b) fine powder B, step c) fine powder E and 0.5 times of amount dextrin, fully mixing.

Medicine of the present invention is according to the syndrome survey result of theory of Chinese medical science, established the Therapeutic Principle of regulating QI and blood, we are the clinical experience sides by the famous old docter of TCM in the whole nation, doctoral advisor, the president Zhou Zhongying professor of former Nanjing Traditional Chinese Medical College (existing Nanjing University of Traditional Chinese Medicine), function regulating QI and blood cure mainly qi and blood derangement of essential hypertension.Disease is seen: the headache feeling of fullness in the head, and complexion is dim red, and in time, warm, and chest has sense of compression or chest pain as thorn, a had palpitation, limbs are scurried pain or stupid fiber crops, menoxenia, xerostomia, thin fur, body of the tongue is dim partially or purpura, ecchymosis, thready and stringy pulse or puckery arranged.Fructus Tribuli suffering in the side, hardship, flat, hardship is let out hot loosing, and lightly floats to dredge to reach, can dispel the wind by suppressing the hyperactive liver, controlling the dizzy pain of the head, but dispersing the stagnated live-QI to relieve the stagnation of QI again, promoting flow of QI and blood and slow distention and pain in chest and hypochondrium." book on Chinese herbal medicine converge with speech " institute says " Fructus Tribuli is dispeled the wind, the medicine of the therapeutic method to keep the adverse QI flowing downwards, Hang Shui, change Disorder also ", discuss can be rated as and want Yan Bufan.Cortex Moutan hardship, suffering are slightly cold, and go into the heart, liver, all warps of kidney, its gas delicate fragrance, bitter cold energy clearing away heat from blood, the hot feasible blood stasis that looses, delicate fragrance can reach again thoroughly, can go into the serum transconversion into heat stasis of blood, kindly clear saturating cloudy again divide stagnated fire, removing heat from blood and do not stay the stasis of blood is invigorated blood circulation and motionless blood, the merit of tool liver heat removing pathogenic fire reducing can be controlled headache, conjunctival congestion, flushing disease.More than two medicines, the Fructus Tribuli circulation of qi promoting to be invigorating blood circulation, the Cortex Moutan removing heat from blood and promoting blood circulation closes and uses it, the regulating QI removing heat from blood is taken into account and is controlled, the aim of the we's argument of hitting is so be listed as monarch.The hot temperature of loosing of Rhizoma Chuanxiong is logical, goes into liver, pericardium channel, can invigorate blood circulation, again can circulation of qi promoting, so the time treasure be called " gas medicine in the blood ", the sea of blood is assigned on the wardrobe mountain peak on the energy, and the bypass extremity are apt to control all diseases of stagnation of QI and blood, diffusing wind analgesic effect is arranged, particularly control the good medicine of headache, assist monarch drug regulating QI and blood, strengthen effect.Radix Cirsii Japonici is sweet, bitter, cool, and GUIXIN, Liver Channel are gone into blood system and cooling blood and removing stasis, cool liver and flat high positive superinverse are so " medical center is usurped and wanted the property of medicine " claims that it can " heat of dehematizing be let out against gas ", share with the monarch drug Cortex Moutan, can the principal drug assistance removing heat from blood and promoting blood circulation with liver heat removing, and can entangle Cortex Moutan hot loose partially.Rhizoma Wenyujin Concisum is hot to loose, hardship is let out, temperature lead to, and going into blood system can blood circulation promoting competent silt, goes into edema caused by disorder of QI and can manage it diffusing stagnant gas, its hot property of loosing and walking crosswise is longer than capable limb arm and promoting blood circulation, so the energy blood-activating and qi-promoting, the breast side of body due to the removing obstruction in the collateral to relieve pain, treatment stagnation of QI and blood and shoulder arm pain numbness, principal drug assistance strengthens the power of promoting flow of QI and blood.So and Rhizoma Chuanxiong, Radix Cirsii Japonici are ministerial drug altogether.Herba Taxilli bitter in the mouth, sweet, property is flat, returns liver, kidney channel, can invigorating the liver and kidney, promote blood circulation and nourish blood, can dispel the wind again and network, go into kidney and enrich blood." book on Chinese herbal medicine is new again " claims it " in the fill temperature, to control the deficiency of YIN, tonifying YANG road ... benefiting blood and regulating blood circulation "." Hunan medicine will " records the Light-headedness that this product is controlled hyperactivity of YANG due to deficiency of YIN, and numb limbs and tense tendons is ached etc., share with Rhizoma Curcumae Longae and benefit is clear.Herba Siegesbeckiae hardship, suffering, cold are gone into the Liver and kidney warp, and the hot hardship of loosing is dry, kind wind-damp dispelling, but heat clearing away again cold in nature can be controlled diseases such as quadriplegia, weakness of the waist and knees, bones and muscles pain, apoplexy and hemiplegia.Clinically show that but this product tack is confused, limb is numb, and blood pressure lowering.But two medicines are also used blood circulation promoting and enriching, and dispelling wind and removing obstruction in the collateral makes so be combined into assistant.

The all medicine compatibilities in full side, regulating QI, circulation of qi promoting and do not consume gas and blood, removing heat from blood and motionless blood are applicable to " the disorder of QI and blood card " of hypertension.The clinical headache feeling of fullness in the head that is applicable to, complexion is dim red, and in time, warm, and chest has sense of compression or chest pain as thorn, a had palpitation, limbs are scurried pain or stupid fiber crops, menoxenia, xerostomia, thin fur, body of the tongue is dim partially or purpura, ecchymosis arranged, thready and stringy pulse or disease such as puckery.

The flavour of a drug of pharmaceutical composition of the present invention are few, thereby not only the efficacy of a drug is special, and are beneficial to and are prepared into modernized preparation, also are beneficial to the quality control of suitability for industrialized production.The toxic and side effects of pharmaceutical composition of the present invention is littler, safe and effective than chemical medicine.

Preparation of drug combination method of the present invention is suitable for commercial Application.Described pharmaceutical composition comprises the various oral formulations that pharmaceutically are suitable for, for example granule, capsule, tablet.The method that the present invention prepares various oral formulations is common method pharmaceutically, as conventional tabletting, granulation, encapsulated etc.The adjuvant of the various oral formulations of preparation that the present invention was suitable for has beta-schardinger dextrin-, magnesium stearate, but those of ordinary skills are the general knowledge conventional adjuvant hyprolose of also drug of choice allusion quotation as required routinely, carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose; Lactose, microcrystalline Cellulose, dextrin, starch, calcium phosphate; Pregelatinized Starch, polyvidone, sodium carboxymethyl cellulose, hypromellose; Pulvis Talci, magnesium stearate, micropowder silica gel, hydrogenated vegetable oil; Sodium lauryl sulphate, Tween 80; Hypromellose, ethyl cellulose etc.

The specific embodiment

Below further set forth the beneficial effect of pharmaceutical composition of the present invention by testing example, these are tested examples and have comprised that pharmacodynamics test and clinical observation on the therapeutic effect test.

The raw materials used medicine Fructus Tribuli of pharmaceutical composition of the present invention, Cortex Moutan, Rhizoma Chuanxiong, Radix Cirsii Japonici, Rhizoma Wenyujin Concisum, Herba Taxilli, Herba Siegesbeckiae are commercially available, and meet standard under 2005 editions pharmacopeia continuous items.

The used oral formulations adjuvant of pharmaceutical composition of the present invention is commercially available, and meets standard under the pharmacopeia continuous item.

Pharmacodynamics result of study before pharmaceutical composition of the present invention is clinical: the blood pressure that can obviously reduce anesthetized rat, clear-headed SHR rat and renal artery stenosis type Hypertensive Rats.Anesthetized rat is onset in 30 minutes after administration, and electrocardiogram is not then had obvious influence; The SHR rat is in administration after 7 days, and blood pressure begins to descend, successive administration drug withdrawal 7 days after 21 days, and heavy dose of (14g/kg) group can obviously delay the rise of blood pressure; Renal artery stenosis type Hypertensive Rats presses off the beginning in 3 days bleeding from anus of administration and descends, successive administration drug withdrawal 7 days after 21 days, and middle dosage (7g/kg), heavy dose of (14g/kg) group can obviously delay the rise of blood pressure.

Acute toxicity testing is the result show: the administration of its mouse oral clothes, LD50 and 95% credible 409.98 (366.59～458.50) g/kg that is limited to.Most mices are dead in 1 day after the administration, all have spontaneous activity in various degree to reduce before the death, dyspnea, and poisoning symptoms such as tic do not find that to dead Mus postmortem internal organs have any tangible abnormal phenomena.

Long term toxicity test: entrust Nanjing Medical University's clinical pharmacology institute to study, through test in 180 days, the result found no tangible toxic reaction.

Claims (7)

1, a kind of pharmaceutical composition for the treatment of qi and blood derangement of essential hypertension is characterized in that being made by the following raw materials in part by weight medicine basically: Fructus Tribuli 7-13 part, Cortex Moutan 6-12 part, Rhizoma Chuanxiong 7-13 part, Radix Cirsii Japonici 9-15 part, Rhizoma Wenyujin Concisum 6-12 part, Herba Taxilli 9-15 Fen, Herba Siegesbeckiae 7-13 part.

2, the medicine of claim 1, wherein the consumption of crude drug is: Fructus Tribuli 9-11 part, Cortex Moutan 8-10 part, Rhizoma Chuanxiong 9-11 part, Radix Cirsii Japonici 11-13 part, Rhizoma Wenyujin Concisum 8-10 part, Herba Taxilli 11-13 Fen, Herba Siegesbeckiae 9-11 part.

3, the medicine of claim 2, wherein the consumption of crude drug is: 10 parts of Fructus Tribulis, 9 parts of Cortex Moutans, 10 parts of Rhizoma Chuanxiongs, 12 parts of Radix Cirsii Japonicis, 9 parts of Rhizoma Wenyujin Concisum, 10 parts of Herba Taxilli 12 Fen, Herba Siegesbeckiaes.

4, the pharmaceutical composition of one of claim 1-3 is characterized in that described pharmaceutical composition contains pharmaceutically acceptable oral formulations adjuvant.

5, the preparation of drug combination method of one of claim 1-3 comprises the following steps:

A) take by weighing each crude drug Fructus Tribuli, Cortex Moutan, Rhizoma Chuanxiong, Radix Cirsii Japonici, Rhizoma Wenyujin Concisum, Herba Taxilli, Herba Siegesbeckiae, standby;

B) the crude drug Cortex Moutan is ground into coarse powder, adds the water distillation, collect distillate, other device of water solution A is deposited standby, and the distillate deepfreeze filters, and gets the paeonol crystallization, with β-CD inclusion, filters, and gets inclusion complex, and drying is ground into fine powder B, and is standby;

C) crude drug Rhizoma Chuanxiong, Rhizoma Wenyujin Concisum two flavors are added the water distillation, extract volatile oil, other device of the aqueous solution C after the distillation is deposited standby, and medicinal residues are used alcohol reflux together with the crude drug Fructus Tribuli, and the extracting solution decompression recycling ethanol also is concentrated into into clear paste D, places standby; Volatile oil filters with β-CD inclusion, gets inclusion complex, and drying is ground into fine powder E, and is standby;

D) crude drug Radix Cirsii Japonici, Herba Taxilli, Herba Siegesbeckiae are decocted with water together with the medicinal residues of Cortex Moutan, decoction liquor leaves standstill, the leaching supernatant, the supernatant that adds the step b) water solution A, the supernatant of step c) aqueous solution C, it is an amount of to add ethanol behind the concentrating under reduced pressure, leave standstill, get supernatant, filter, decompression filtrate recycling ethanol also is condensed into clear paste F, add step c) clear paste D, abundant mixing, drying under reduced pressure, pulverize, get clear paste dry powder G;

E) clear paste dry powder G adds step b) fine powder B, step c) fine powder E and appropriate amount of auxiliary materials, abundant mixing, the active component of pharmaceutical composition of the present invention.

6, claim 5 preparation of drug combination method, wherein

Step b) is ground into coarse powder with the crude drug Cortex Moutan, adds the water distillation, collect 8-10 and doubly measure distillate, other device of water solution A is deposited standby, and distillate low temperature (5～8 ℃) cold preservation is spent the night, and filters, the paeonol crystallization, dry (40～45 ℃), add the small amount of ethanol dissolving after, with β-CD that 7-9 doubly measures, inclusion, low temperature (5～8 ℃) cold preservation is spent the night, filter, get inclusion complex, drying is ground into fine powder B; Step c) Rhizoma Chuanxiong, Rhizoma Wenyujin Concisum two flavors add the water distillation, extracted volatile oil 3-5 hour, aqueous solution C after distillation device in addition deposits standby, medicinal residues are used 65%-75% alcohol reflux 2 times together with the crude drug Fructus Tribuli, add 8-12 at every turn and doubly measure ethanol, extracting solution decompression recycling ethanol and to be condensed into relative density be 1.10～1.25 (95～100 ℃ of surveys) clear paste D, place standby, β-CD that volatile oil is doubly measured with 7-9, inclusion, low temperature (5～8 ℃) cold preservation is spent the night, filter, get inclusion complex, drying is ground into fine powder E; The step d) Radix Cirsii Japonici, Herba Taxilli Herba Siegesbeckiae decocts with water secondary together with the medicinal residues of Cortex Moutan, decoction liquor left standstill 24 hours, the leaching supernatant, the supernatant that adds the step b) water solution A, the supernatant of step c) aqueous solution C, being evaporated to relative density is 1.10～1.25 (95～100 ℃ of surveys), adding ethanol transfers and to contain alcohol and measure to 65%-75%, left standstill 24 hours, and got supernatant, filter, decompression filtrate recycling ethanol also is concentrated into the clear paste F that relative density is 1.10～1.25 (95～100 ℃ of surveys), add step c) clear paste D, abundant mixing, drying under reduced pressure, pulverize, get clear paste dry powder G; Step e) gets fine powder F with fluid extract E spray drying; E) clear paste dry powder G is added step b) fine powder B, step c) fine powder E and an amount of dextrin, fully mixing.

7, claim 6 preparation of drug combination method, wherein

Step b) is ground into coarse powder with the crude drug Cortex Moutan, adds the water distillation, collect 9 times of amount distillates, other device of water solution A is deposited standby, and distillate low temperature (5～8 ℃) cold preservation is spent the night, and filters, the paeonol crystallization, dry (40～45 ℃), add the small amount of ethanol dissolving after, with the β-CD of 8 times of amounts, 80 times of water gagings stirred inclusion 1 hour under 50 ℃ of conditions, low temperature (5～8 ℃) cold preservation is spent the night, and filters, and gets inclusion complex, 45 ℃ of dryings of inclusion complex are ground into fine powder B; Step c) Rhizoma Chuanxiong, Rhizoma Wenyujin Concisum two flavors add the water distillation, extracted volatile oil 4 hours, aqueous solution C after distillation device in addition deposits standby, medicinal residues together with the crude drug Fructus Tribuli with 70% alcohol reflux 2 times, add 10 times of amount ethanol at every turn, extracting solution decompression recycling ethanol and to be condensed into relative density be 1.15～1.20 (95～100 ℃ of surveys) clear paste D, place standbyly, volatile oil is with the β-CD of 8 times of amounts, 80 times of water gagings, under 30 ℃ of conditions, stirred inclusion 1 hour, low temperature (5～8 ℃) cold preservation is spent the night, and filters, and gets inclusion complex, 50 ℃ of dryings of inclusion complex are ground into fine powder E; The step d) Radix Cirsii Japonici, Herba Taxilli Herba Siegesbeckiae decocts with water secondary together with the medicinal residues of Cortex Moutan, each 2 hours, merge decoction liquor, decoction liquor left standstill 24 hours, the leaching supernatant, the supernatant of adding step b) water solution A, the supernatant of step c) aqueous solution C, being evaporated to relative density is 1.15～1.20 (95～100 ℃ of surveys), add the ethanol accent and contain the alcohol amount to 70%, left standstill 24 hours, and got supernatant, filter, decompression filtrate recycling ethanol also is concentrated into the clear paste F that relative density is 1.15～1.20 (95～100 ℃ of surveys), add step c) clear paste D, abundant mixing, drying under reduced pressure, pulverize, get clear paste dry powder G; Step e) gets fine powder F with fluid extract E spray drying; E) clear paste dry powder G is added step b) fine powder B, step c) fine powder E and 0.5 times of amount dextrin, fully mixing.