CN1275609C - Chinese medicinal preparation for treating cardiovascular and cerebrovascular diseases and its preparing process - Google Patents

Abstract

The present invention relates to a traditional Chinese medicine preparation for treating cardiovascular and cerebrovascular diseases and a preparing method thereof. The preparation is mainly prepared from Herba Rhodiolae and breviscapine. Compared with the prior art, the preparation of the present invention is mainly prepared from Herba Rhodiolae and breviscapine, and has the functions of nourishing qi and warming yang, promoting blood circulation and eliminating blood stasis, and activating channel and killing pain; Herba Rhodiolae and breviscapine have good functions of cooperation and efficiency enhancement; the prepared injection has the characteristics of quick effect and high biologic utilization, and the prepared injection can alleviate symptoms as soon as possible, especially for serious patients. Verified by clinical experiments, the preparation of the present invention has obvious curative effect on ischemic cerebral apoplexy, sequela of apoplexy, obstruction of qi in the chest and cardiodynia.

Description

Be used for the treatment of Chinese medicine preparation of cardiovascular and cerebrovascular disease and preparation method thereof

Technical field: the present invention relates to a kind of Chinese medicine preparation that is used for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof, belong to the field of traditional Chinese medicine technology.

Background technology: coronary atherosclerotic heart disease (abbreviation coronary heart disease) is the most important chronic disease of present industrialized country.With the U.S. that 200,000,000 populations are arranged is example, and the number of dying from coronary heart disease every year reaches 600,000, is used for annual about 5,000,000,000 dollars of the expense of coronary heart disease diagnosis and treatment.Except economic loss, coronary heart disease is returned the loss that patient, family members and kith and kin bring spiritual aspect, so coronary heart disease is called as " first killer " of industrialized country.Many developing countries (comprising China) Incidence of CHD also constantly rises over nearly 20 years.Chief reason is that infectious disease is controlled, the change of life style and population life-span prolong.Cerebrovascular is called apoplexy again or apoplexy is one of most important cerebrovascular of most industrialized countries, and its mortality rate accounts for second or the 3rd of the full cause of the death of crowd.In China, Japan and some countries based on Asian Peoples, apoplexy is serious than coronary heart disease to crowd's the extent of injury.Particularly about 3/4 patient has labour force in various degree to lose among the cerebrovascular disease survivor, and severe disabled person accounts for 40%.Show according to statistics, the sickness rate of cardiovascular and cerebrovascular disease, prevalence and mortality rate increase with the growth at age, the M ﹠ M of the natural population of China more than 60 years old is higher, along with the quickening of aging process, China has stepped into aging society, and is more urgent for the needs of treatment cardiovascular and cerebrovascular diseases medicament, and the medicine that is used for cardiovascular and cerebrovascular disease that goes on the market at present, though Western medicine preparation is effective but toxic and side effects is bigger, untoward reaction is more, and the Chinese medicine preparation effect is also not ideal enough.The Chinese patent communique discloses name, and to be called " compound oral liquid preparation of alpine rhodiola root and preparation technology thereof ", application number be 93102898.1 patent application, it is made of in right amount Radix Rhodiolae, the Radix Astragali, Fructus Lycii and Mel, and description is introduced it effective activating brain cell, strengthen cardiovascular function, can make two-ways regulation, human body immunity improving ability, resisting fatigue, defying age to blood glucose, blood pressure.But we find that its effect is unsatisfactory in actual application; The Chinese patent communique discloses that name is called " healthful wine of rhodiola root ", application number is: 94107917.1 technology, this product are a kind of wine product, obviously are not suitable for the cerebrovascular patient and use; The Chinese patent communique discloses also that application number is 99102847.3, name is called " a kind of rhodiola rosea injection for the treatment of angina pectoris ", put down in writing in the application documents: its raw material is by separation and Extraction in the Chinese medicine Radix Rhodiolae, and main effective ingredient is rhodioloside and butyl alcohol.Pharmacological evaluation shows to have the obvious effect that improves dog acute myocardial ischemia and myocardial infarction, alleviates the myocardial damage degree, obviously reduces serum paraoxonase creatine phosphate kinase (CK) content, and obviously dilating coronary blood vessel reduces coronary resistance., effect rapid-action through the obstruction of qi in the chest and cardialgia (angina pectoris) that intravenously administrable or oral administration cause stagnation of heart-blood obviously, effect is lasting.But because single use Radix Rhodiolae experimental studies have found that what we carried out its effect is also undesirable as the preparation raw material; It is 03126742.4 that nearest Chinese patent communique discloses " a kind of rhodiola kirilowii Regel injectable powder and preparation method thereof " application number, this disclosure of the Invention a kind of rhodiola kirilowii Regel injectable powder, it is to be raw material after extraction, purification, an amount of pharmaceutic adjuvant allotment of adding with the Chinese herbal medicine rhodiola kirilowii Regel, be prepared from freeze-drying method, its main active is: rhodioloside, butyl alcohol and total flavones; This description is thought: the product stability that provides is good, effect duration is long, shows to have to resist myocardial ischemia significantly and treating cerebral ischemia that cardiovascular and cerebrovascular diseases such as coronary heart disease, cerebral infarction are had excellent curative through pharmacodynamics test.But because still single use Radix Rhodiolae finds that as the preparation raw material its effect is also unsatisfactory in the contrast experiment that we did.

Summary of the invention: the objective of the invention is to: provide a kind of and can treat Chinese medicine preparation of cardiovascular and cerebrovascular disease and preparation method thereof.The present invention constitutes like this: calculate according to components by weight percent: it mainly is prepared from by Radix Rhodiolae 600-1400 part and breviscapine (in the lamp-dish flower acetic that wherein contains) 20-60 part.Specifically: calculate according to components by weight percent: it is prepared from by 1000 parts of Radix Rhodiolaes and 40 parts of breviscapines (in lamp-dish flower acetic) and appropriate amount of auxiliary materials.Described adjuvant comprises according to the different dosage form of preparation: sucrose, dextrin, starch, polyacrylic resin, micropowder silica gel, carboxymethyl starch sodium, magnesium stearate, PEG-6000, mannitol.Preparation of the present invention comprises granule, hard capsule, soft capsule, tablet, drop pill, oral liquid, injection, comprising: injection, glucose infusion liquid, freeze-dried powder, slow releasing preparation, controlled release preparation etc.The preparation method of the Chinese medicine preparation of this treatment cardiovascular and cerebrovascular disease is: after Radix Rhodiolae being adopted the method effective component extracting of decocting in water or percolation, add breviscapine again and suitable adjuvant is prepared into different preparations.

Granule of the present invention can prepare like this: get Radix Rhodiolae and decoct with water 2 times, merge 2 times decocting liquid, filter, filtrate decompression is condensed into clear paste, adds breviscapine and sucrose, dextrin, and mixing is granulated, sieve, and drying, granulate, packing is promptly.The advantage of this dosage form is: comfortable taste, effect are rapidly; Volume is little, and take and transportation etc. makes things convenient for; Cost is low.

Capsule of the present invention can prepare like this: get Radix Rhodiolae and decoct with water 2 times, merge 2 times decocting liquid, filter, filtrate decompression is condensed into clear paste, and spray drying adds breviscapine and starch, mixing is granulated, and sieves, drying, granulate, coating, packing, that is, wherein coating material can prepare like this: get 1.8g polyacrylic resin and the abundant mixing of 95% ethanol 36ml, soak after 24 hours, filter, promptly.This dosage form advantage is: outward appearance is clean and tidy, and is beautiful, easily swallows; Dosage is accurate, the bioavailability height; Medicine stability is good; Production, transportation etc. are convenient.

Tablet of the present invention can prepare like this: get Radix Rhodiolae and decoct with water 2 times, merge 2 times decocting liquid, filter, filtrate decompression is condensed into clear paste, and spray drying adds breviscapine and micropowder silica gel, mixing is granulated, and sieves, drying, granulate adds carboxymethyl starch sodium and magnesium stearate, mixing, tabletting, the bag film-coat, promptly, wherein coating material can prepare like this: get the 9g polyacrylic resin, add 95% ethanol 170ml, soak 24 hours to all dissolvings, other gets 1.5gPEG-6000 and adds a small amount of hot water and make it dissolving, in the adding in the resin solution, stir evenly, filter, get final product.The advantage of this dosage form is: dosage is accurate, steady quality; Take, produce, transportation etc. is convenient; Medicine stability is good; Mechanization is produced, and output is big, and cost is little.

Drop pill of the present invention can prepare like this: get Radix Rhodiolae, be ground into coarse powder, add ethanol percolation, percolate reclaims ethanol, adds the water boil dissolving after concentrating, filter, filtrate concentrates the back with water saturated equal-volume sec-butyl alcohol extraction 3 times, the reclaim under reduced pressure sec-butyl alcohol, and filtrate is concentrated into dried, pulverize for fine powder, with the breviscapine mixing; Other gets PEG-6000 after being heated to fusion in the water-bath, adds said mixture, stirs evenly, and 80-90 ℃ of insulation dissolved in the cold liquid paraffin, and inhale and remove surface liquid paraffin, drying, promptly.The advantage of this dosage form is that onset is rapid, and curative effect is lasting, and dosage is accurate.

Injection of the present invention prepares like this: get Radix Rhodiolae, be ground into coarse powder, add ethanol percolation, percolate reclaims ethanol, add the water boil dissolving after concentrating, filter, filtrate concentrates the back with water saturated equal-volume sec-butyl alcohol extraction 3 times, the reclaim under reduced pressure sec-butyl alcohol, ethanol with ethanol elution, is reclaimed in the concentrated back of filtrate on polyamide chromatography post, eluent adds water boil after concentrating, filtrate is condensed into dense clear paste, adds breviscapine again and suitable adjuvant prepares injection, glucose infusion liquid, freeze-dried powder.

Injection can prepare like this: Radix Rhodiolae extract adds the injection water and stirs evenly, and regulates about pH to 9.0 with sodium hydroxide solution, boils, and filters, and filtrate is regulated about pH to 6.5 with citric acid soln, filters clear and bright; Breviscapine adds the injection water and stirs evenly, and regulates pH to about 7.5 with sodium hydroxide solution, filters clear and brightly, and filtrate is mixed with above-mentioned Radix Rhodiolae extract solution, heat, and activated carbon adsorption, about adjusting pH to 6.5, filtration, embedding, promptly.

Glucose infusion liquid can prepare like this: Radix Rhodiolae extract adds the injection water and stirs evenly, and regulates about pH to 9.0 with sodium hydroxide solution, boils, and filters, and filtrate is regulated about pH to 6.5 with citric acid soln, filter, Radix Rhodiolae extract solution; Breviscapine adds the injection water and stirs evenly, and regulates about pH to 7.5 with sodium hydroxide solution, filters, and filtrate and Radix Rhodiolae extract solution merge, regulate about pH6.5, and heating, filtrate for later use is filtered in activated carbon adsorption; After getting glucose and adding injection water boils dissolving, activated carbon adsorption, filtering decarbonization pumps into rare joining in the cylinder after clear and bright, adds above-mentioned Radix Rhodiolae extract and breviscapine filtrate, adds water to full dose, regulates about pH to 5.3, filters clear and brightly, and embedding is sterilized, promptly.

Freeze-dried powder can prepare like this: Radix Rhodiolae extract adds the injection water and stirs evenly, and regulates about pH to 9.0 with sodium hydroxide solution, boils, and filters, and filtrate is regulated about pH to 6.5 with citric acid soln, filter, Radix Rhodiolae extract solution; Breviscapine adds the injection water and stirs evenly, and regulates about pH to 7.5 with sodium hydroxide solution, filters, and filtrate and Radix Rhodiolae extract solution merge, regulate about pH6.5, and heating, filtrate for later use is filtered in activated carbon adsorption; Get mannitol and add the injection water and boil dissolving, activated carbon adsorption, filtering decarbonization adds the above-mentioned mixed liquor of handling well, adds water to full dose, about adjusting pH to 6.5, filters clear and brightly, aseptic subpackaged, and lyophilization is sealed, promptly.

Intravenous injection provided by the invention has the characteristics that drug effect plays a role soon, bioavailability is high, is used for the severe case, relief of symptoms as early as possible, and the small-volume injection cost is low, is convenient to transportation and stores; The direct venoclysis of infusion solution has reduced the chance of secondary pollution, is convenient to clinical medical and nursing personnel's use; Freeze-dried powder stability is better, and transportation and preservation are convenient in anti-storage.

Compared with prior art, the present invention is that basic prescription is prepared from Radix Rhodiolae and breviscapine, has the QI invigorating warming YANG, blood circulation promoting and blood stasis dispelling, the effect of removing obstruction in the collateral to relieve pain; The compatibility of two kinds of medical materials has reasonable collaborative, synergic effect; The injection for preparing has the characteristics that the drug action performance is fast, bioavailability is high, especially for middle severe case, relief of symptoms as early as possible; It is remarkable especially that clinical trial certificate the present invention treats ischemia apoplexy and apoplexy sequela and chest arthralgia precordial pain syndrome curative effect.

According to theory of Chinese medical science, cardiovascular and cerebrovascular disease comprises cerebral infarction and apoplexy sequela and chest arthralgia precordial pain syndrome etc.; Chest arthralgia precordial pain syndrome, mainly by blood stasis due to qi deficiency, the visceral-qi deficiency, the gasification imbalance, blood operation in Tianjin is not smooth, is condensed into expectorant with the bringing about the spread of body fluid, the not smooth one-tenth stasis of blood of blood, expectorant stasis of blood impatency is due to heart arteries and veins is obstructed; Cerebral ischemia diseases is mainly disorderly contrary by QI and blood, and channels overflows broken, and blood oozing from the body openings or subcuta neous tissue is outside arteries and veins, and brains are injured, blood stasis, and expectorant is turbid, and diseases caused by retention of fluid gathers, and causes brain arteries and veins obturation, and unit is refreshing stranded, key machine obturation, the five internal organs lose system, and six internal organs are gas-tight, due to limbs are become estranged.Can select for use QI invigorating and body resistance strengthening medicine and drug for invigorating blood circulation and eliminating stasis prescription to control it.The traditional Chinese medical science is thought: " gas is that blood declines, Qi and blood deficiency, sering is not filled, qi depression to blood stasis ".The traditional Chinese medical science is also thought: kidney is the root of life, is the congenital foundation, and kidney is the root of the five internal organs, hides the essence of the five internal organs, kidney governing inspiration, and aerial root belongs to lung in kidney, so help air-breathing and respectful the falling of lung; Meet at kidney under the kidney-water ascending to coordinate with the heart, heart-fire, extreme misery mutual aid, then equilibrium between yin and yang; The kidney being the origin of congenital constitution, the spleen being the foundation of acquired constitution, and the strong fortune of spleen depends on the warm of kidney yang; The Liver and kidney part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels of living together, edema with the liver involved need rely moistening of kidney water foster, the kidney essense abundance, then liver also must nourish.The bladder master holds body fluid, and motive row water, but the gasification of bladder need the transpiration of kidney qi.Then cause a series of interactional strain processes of body if suffer from a deficiency of the kidney, so saying of " all kinds of diseases and ailments being born in kidney " arranged.The sick position of coronary heart disease is at the heart, and old complaint is at kidney, so suffering from a deficiency of the kidney is cause atherosclerosis, initiation coronary heart disease basic.Nourishing kidney-yin, kidney-replenishing, the kidney invigorating gas can stop atherosclerotic generation and development, thereby prevent and treat coronary heart disease.The above-mentioned cardiovascular and cerebrovascular disease of Chinese traditional treatment should use QI invigorating warming YANG or QI invigorating drugs for nourishing yin and activating blood circulation to dissipate blood stasis and dredge the collateral analgesic prescription to use it.

Radix Rhodiolae is a qi-restoratives medicine, has strengthening by means of tonics, kidney-replenishing, and the beneficial motive, blood circulation promoting and blood stasis dispelling, clearing away lung-heat to relieve cough, effects such as antipyretic analgesic are used to have a headache and fever, malaise, shortness of breath and palpitation, feeling of oppression and pain in the chest, diseases such as physical weakness; Breviscapine is the flavone component that extracts in the Herba Erigerontis, has blood circulation promoting and blood stasis dispelling, and the effect of removing obstruction in the collateral to relieve pain is used for apoplexy sequela, obstruction of qi in the chest and cardialgia (angina pectoris).But QI invigorating warming YANG behind the two medicine prescriptions, blood circulation promoting and blood stasis dispelling, removing obstruction in the collateral to relieve pain is used for ischemia apoplexy and apoplexy sequela and chest arthralgia precordial pain syndrome (angina pectoris), meets theory of Chinese medical science, is rationally feasible.

According to modern medicine and pharmacology research and documents and materials, Radix Rhodiolae contains effective ingredient such as Radix Rhodiolae glycoside, flavonoid and several amino acids, has body-building, and is strong, the function in the degeneration-resistant border of enhancing body; Studies show that, Radix Rhodiolae has the human body immunity improving function, defying age, anti-hypoxia, resisting fatigue, radioprotective, cold resistance, anti-peroxidation, antiinflammatory, enhancing cardiac function improve the heart and brain blood flow, improve multiple effects such as myocardial ischemia, calmness, hypnosis, excited respiratory center; Breviscapine is the flavone component that is extracted by Herba Erigerontis; modern pharmacological research shows; breviscapine has the brain microcirculation of improvement; the cerebral blood flow increasing amount, protection cerebral tissue activities of antioxidant enzymes suppresses lipid peroxidation; alleviate the infringement of radical pair cerebral tissue; the ischemia-reperfusion cerebral tissue there is protective effect, increases myocardial flow, can block the Ca of myocardial cell ²⁺Passage reduces Ca ²⁺Interior stream reduces myocardial oxygen consumption, and ischemic myocardial is had protective effect; Have antiplatelet aggregation, blood viscosity lowering improves effects such as hemorheology.In the pharmacological toxicology research that we did, proved this two medicines prescription coupling, can remedy pharmacological action mutually and strengthen its pharmacological action mutually, made the above-mentioned cardiovascular and cerebrovascular disease of treatment more effective.

The applicant is an example with injection provided by the invention, and by pharmacological toxicology research, the result shows:

1, the anti-focal cerebral ischemia and the full brain blood test of pesticide effectiveness behind the two medicine prescriptions, than the effect enhancing of single medicine, experimental result sees Table 1,2,3.

Table 1 explanation breviscapine group can reduce model dog cerebral tissue ischemic region weight and ischemic tissue of brain percentage rate, and the Radix Rhodiolae group does not have this effect, and both strengthen in the effect of share.

Table 2 explanation breviscapine group can raise dog middle cerebral artery mean blood flow velocity and peak velocity, and this effect of Radix Rhodiolae group is not obvious, has more the effect of obvious increasing blood flow after both share.

Table 3 explanation Radix Rhodiolae group has obvious effect, and the effect of breviscapine group is not obvious, and both strengthen in the effect of share.

2, to the myocardial ischemia test of pesticide effectiveness, two medicines prescription has the better protection effect to myocardial infarction, and experimental result sees Table 4-13:

Table 4 explanation Radix Rhodiolae and breviscapine all can dwindle infarction size, and the Radix Rhodiolae group can significantly reduce animal pattern CPK, and the breviscapine group can significantly reduce LDH and the CPK of animal pattern.

Table 5-12 explanation Radix Rhodiolae group can be alleviated due to the model dog myocardial ischemia ST section and raises, and the breviscapine group has obvious or significant improvement effect to the decline of cardiac contractility ability (LVP and LV+dp/dt).

Table 13 explanation Radix Rhodiolae group can reduce the ischemic myocardium oxygen consumption.After two component compatibilities use, the scheming infarction of LAD ligation there is the better protection effect.

3, blood circulation promoting and blood stasis dispelling test has stronger change blood flow, thrombolytic effect than single medicine behind the two medicine prescriptions, antiplatelet aggregative activity, and experimental result sees Table 14-20:

Table 14-18 explanation Radix Rhodiolae group and breviscapine group all have the effect of the microcirculation of mouse auricle of improvement, and both obviously strengthen in the effect of share.

Table 19-20 explanation Radix Rhodiolae group and breviscapine group all have fibrin in the accelerate dissolution blood plasma, shorten the effect of fibrinolysis time, and the breviscapine group is better than the Radix Rhodiolae group, but no significant difference, both share the back effect and strengthen.

4, anti-stress test, this injection behind the prescription strengthens than single medicine effect, and experimental result sees Table 21-22:

Table 21-22 explanation Radix Rhodiolae group has obvious resisting fatigue and anti-normobaric hypoxia effect (p＜0.05), and breviscapine group effect not obvious (p＞0.05), both strengthen in the effect of share.

5, the LD50 of mouse peritoneal and intravenously administrable is respectively clinical plan with more than 900 times and 750 times of dosage respectively greater than 1200mg/kg and 1000mg/kg, and is as safe as a house, compares with single medicine, and the acute toxicity basically identical increases.

6, rat and Beagle Canis familiaris L. 12 girths poison result shows that toxicity and single medicine behind the two medicine prescriptions more do not increase.

The clinical observation and the curative effect of treatment cardiovascular and cerebrovascular disease:

According to " medicine registration management way " and " specification requirement of new Chinese medicine clinical research ", adopt at random, positive drug parallel control, multicenter study scheme, for the safety and the clinical efficacy of this new drug treatment cardiovascular and cerebrovascular disease are estimated.

1. case choice criteria

1.1 diagnostic criteria

1.1.1 tcm diagnosis standard

1. formulate with reference to " the clinical research guideline of new Chinese medicine treatment apoplexy ".

2. formulate with reference to " the clinical research guideline of the new Chinese medicine treatment thoracic obstruction (angina pectoris) ".

1.1.2 differential diagnosis in tcm

1. 1. formulate with reference to 4.1.1-

2. 2. formulate with reference to 4.1.1-

1.1.3 Western medicine diagnose standard

1. " all kinds of cerebrovascular disease diagnosis main points " revised for the third time with reference to Chinese Medical Association in 1989 national cerebrovascular academic conference for the second time

A. transient ischemic attack

B. cerebral thrombosis

C. cerebral embolism

2. with reference to international heart association and association and World Health Organization's clinical name standardization associating special topic group report " name of ischemic heart desease and diagnostic criteria "

1.1.4 (classification) standard by stages

1. apoplexy standard by stages

A. acute stage: in 2 weeks of falling ill; B. convalescent period: fell ill for 2 thoughtful half a year; C. sequela stage: more than morbidity half a year.

2. thoracic obstruction weight grade scale (with reference to therapy of combining Chinese and Western medicine angina pectoris in 1979 and arrhythmia forum " angina pectoris and ECG curative effect evaluation criteria ")

1.2 include the case standard in

1. apoplexy is included the case standard in

The patients during acute stage that meets the apoplexy diagnostic criteria can be included the test case in.

2. the thoracic obstruction is included the case standard in

Have thoracic obstruction primary symptom, disease is disconnected clear and definite, meets differential diagnosis in tcm, and the twice above angina pectoris patient that show effect weekly can include the test case in.

2. observation index

2.1 safety observation

A. general health check-up project;

B. blood, urine, the just chemical examination of routine;

C. the heart, liver, kidney function test

2.2 health giving quality observation

1. apoplexy health giving quality observation

A. patient's mind, language and motor function;

B. nervous system signs;

C. examination of cerebrospinal fluid;

D. Cranial Computed Tomography scanning;

E. blood examination;

F. echoencephalography;

G. nuclear magnetic resonance check.

2. thoracic obstruction health giving quality observation

A. tcm symptom, the variation of tongue, arteries and veins is observed;

B. angina pectoris attacks time, number of times, degree, persistent period, induced factor, nitroglycerin dose;

C. Electrocardioscopy;

D. specific heart isozyme, lipids detection;

E. blood examination;

F. cardiac inspection;

G. exercise ECG inspection;

H. vectorcardiogram inspection;

I. dynamic ecg recordings examination;

J. standard cardioelectric figure checks.

3. curative effect determinate standard

3.1 apoplexy curative effect determinate standard

3.1.1 apoplexy point system

3.1.2 apoplexy efficacy assessment standard

Adopt the nimodipine method:

A. be almost recovered: 〉=85%. B. produce effects: 〉=5%. C. effective: 〉=20%. D. invalid:＜20%.

3.2 thoracic obstruction curative effect determinate standard

3.2.1 thoracic obstruction symptom criterion of therapeutical effect (with reference to therapy of combining Chinese and Western medicine angina pectoris in 1979 and arrhythmia forum " angina pectoris and ECG curative effect evaluation criteria ")

3.2.2 ECG curative effect evaluation criteria (with reference to therapy of combining Chinese and Western medicine angina pectoris in 1979 and arrhythmia forum " angina pectoris and ECG curative effect evaluation criteria ")

4. test method

240 patients that will meet selected condition are randomized into treatment group and matched group, and the treatment group is taken this medicine, must not use the medicine relevant with apoplexy, lasts for 2 weeks.

5. safety evaluatio

This test, the treatment group is observed 124 examples altogether, produce effects 56 examples wherein, effective 68 examples, invalid 19 examples, total effective rate 84.6%, viewing duration are not found toxicity, side effect and untoward reaction, result of the test confirms that this medicine treatment ischemia apoplexy and apoplexy sequela and chest arthralgia precordial pain syndrome are evident in efficacy, is safe and reliable new Chinese medicine.

Preparation for various dosage forms need be selected different adjuvants, technology for use, and we have also made experimental selection:

For granule:

Select sucrose+dextrin foundation (from mouldability, granule yield, cost):

The investigation project	Adjuvant
				Sucrose	Dextrin	Sucrose+dextrin (1.4: 1)
	Mouldability	Difference	Very				Very
Granule yield (%)				91	96	95
	Cost (unit/bag)	1.5	3.1				2.4

For capsule:

Select starch according to (from mouldability, granule repair to the angle, RH)

The investigation project	Adjuvant
			Starch	Dextrin
	Mouldability	Very			Very
Granule repair to the angle (°)			35.5	40
	RH(％)	54			62

For tablet:

Select the foundation (from mouldability, repair, RH, disintegration) of micropowder silica gel+carboxymethyl starch sodium to the angle:

The investigation project	Adjuvant
					Blank	Starch	Micropowder silica gel	Micropowder silica gel+carboxymethyl starch sodium
	Mouldability	Difference	Generally	Very					Very
Granule repair to the angle (°)					47	45	37	36.2
	RH(％)	76	54	31					31.5
Disintegration					123		27	11

For drop pill:

Water extraction, ethanol refluxing process, percolation are selected three kinds of extracting method gained fluid extract mass ratioes:

Extracting method	Gained fluid extract amount (ml)	Rhodioside content (mg/ml)
			(1) decocting method (2) ethanol reflux extraction (3) percolation	200 200 200	4.05 4.17 4.33

The main effective ingredient of Radix Rhodiolae is a rhodioside, thus with the content of rhodioside as the index of weighing the extracting method quality, the result shows that the rhodioside content that water extraction and ethanol refluxing process extract is lower, and percolation content is the highest.Therefore, adopt the extracting method of percolation as this preparation.

For injection:

Radix Rhodiolae extract process for refining The selection result

The investigation project	1. sec-butyl alcohol extraction	2. polyamide chromatography method	3. sec-butyl alcohol extracts polyamide chromatography composite algorithm
				Rhodioside extract amount (ml) Determination of Salidroside (mg/ml) extract solid content (mg/1ml) protein tannin resin oxalates potassium ion	100 34.52 341.2 do not detect	100 33.29 334.6 do not detect	100 35.55 274.4 do not detect

Sec-butyl alcohol extraction polyamide chromatography composite algorithm effect is better, not only extract obtained content (purity) height, and also the solid content amount is much lower, therefore adopts sec-butyl alcohol extraction polyamide chromatography composite algorithm technology to make with extra care.For glucose infusion liquid:

The isoosmotic adjusting agent prescription of design

The prescription composition	Isoosmotic adjusting agent prescription consumption
			1	2
	Radix Rhodiolae breviscapine (in lamp-dish flower acetic) 10% sodium hydroxide solution sodium chloride glucose injection water adds to	10g 0.4g is an amount of/50g 1000ml			An amount of 9g/the 1000ml of 10g 0.4g

The selection result:

The investigation project	The isoosmotic adjusting agent prescription is investigated the result
			1	2
	Appearance character pH value rhodioside (mg/100ml) lamp-dish flower acetic (mg/100ml) sodium chloride (%) glucose (%)	Pale brown color clear liquid 5.53 3.37 41.28/99.26			Dark brown yellow clear liquid 5.45 3.40 1.71 96.21/

The result shows that prescription 2 usefulness sodium chloride adjustings etc. are oozed, and breviscapine content descends more than 90%, the medicinal liquid color burn; Prescription 1 usefulness glucose adjusting etc. is oozed, and does not influence active constituent content, and medicinal liquid is clear and bright, and color is not deepened yet.Therefore, select for use 5% glucose as isoosmotic adjusting agent.

For freeze-dried powder:

Mannitol uses separately, can play loose and hydrotropy effect simultaneously.

The excipient prescription of design:

The supplementary material title	Prescription numbering and consumption (in the 0.2g/ bottle) thereof
				1	2	3
	Radix Rhodiolae breviscapine (in lamp-dish flower acetic) mannitol 10% sodium hydroxide solution water for injection adds to the preparation specification	An amount of 2.0ml 0.20g of 1g 40mg 120mg	An amount of 2.0ml 0.15g of 1g 40mg 60mg				An amount of 2.5ml 0.25g of 1g 40mg 170mg

The selection result:

The investigation project	Projects are investigated the result
				Prescription 1	Prescription 2	Prescription 3
	Appearance character dissolving situation pH value clarity	Yellow loose block, full, do not see atrophy, the color and luster homogeneous easily dissolves, and brownish red clear liquid 6.46 clarity are qualified	Yellow block, not full, obviously atrophy, color and luster heterogeneity solubilized, brownish red clear liquid 6.44 clarity are qualified				Yellow loose block, fuller, slightly atrophy, but the color and luster heterogeneity is easily dissolved, and brownish red clear liquid 6.52 clarity are qualified

The freeze-drying prods of prescription 1 and 3 is preferable, and the content after the lyophilizing is full, does not have atrophy, is loose block, color and luster homogeneous, and all easily dissolvings in 4ml water.Therefore, under the situation that obtains effect same,, select the excipient prescription of prescription 1, promptly use the raising agent and the cosolvent of mannitol (every bottle of 120mg) as this preparation as this preparation in order to save mannitol.

From this, the present invention is the most scientific and rational for the selection of adjuvant, technology.

The specific embodiment

Embodiments of the invention 1: get Radix Rhodiolae 600g and decoct with water 2 times,, adding 8 times of amounts of water for the first time, the time is 2 hours; Add 6 times of amounts of water for the 2nd time, the time is 1.5 hours, merges 2 times decocting liquid, filters, filtrate decompression is condensed into clear paste 1.30 (50 ℃), adds breviscapine (in lamp-dish flower acetic) 60g and sucrose 350g, dextrin 250g, and mixing is granulated, cross 12 mesh sieves, 60 ℃ of dryings, granulate, packing is promptly.Boiled water is taken after mixing it with water, 3 times on the one, one time 1 bag.

Embodiments of the invention 2: get Radix Rhodiolae 1400g and decoct with water 2 times, merge 2 times decocting liquid, filter, filtrate decompression is condensed into clear paste 1.20 (50 ℃), and spray drying adds breviscapine (in lamp-dish flower acetic) 20g and starch 55g, mixing, granulate, sieve drying, granulate, coating, packing, promptly.Boiled water is taken after mixing it with water, 3 times on the one, one time 2.Coating material preparation: get 1.8g polyacrylic resin and the abundant mixing of 95% ethanol 36ml, soak after 24 hours, filter, promptly.

Embodiments of the invention 3: get Radix Rhodiolae 600g and decoct with water 2 times, merge 2 times decocting liquid, filter, filtrate decompression is condensed into clear paste 1.15 (50 ℃),, spray drying, add breviscapine (in lamp-dish flower acetic) 20g and micropowder silica gel 24g, mixing is granulated, sieve drying, granulate, add carboxymethyl starch sodium 1.1g and magnesium stearate 0.5g, mixing, tabletting, the bag film-coat, promptly.Use mixing in water for oral taking, 3 times on the one, one time 1.

Coating material preparation: get the 9g polyacrylic resin, add 95% ethanol 170ml, soaks 24 hours to all dissolvings, other gets 1.5gPEG-6000 and adds a small amount of hot water and make it dissolving, in the resin solution, stirs evenly in the adding, and filtration gets final product.

Embodiments of the invention 4: get Radix Rhodiolae 1400g, be ground into coarse powder, add 12 times of amount 60% ethanol percolations, percolate reclaims ethanol, is concentrated into to add 6 times of water gagings behind 1.2 (60 ℃) and boil dissolving, filter, filtrate is concentrated into 1.1 (60 ℃) back with water saturated equal-volume sec-butyl alcohol extraction 3 times, the reclaim under reduced pressure sec-butyl alcohol, and filtrate is concentrated into dried, pulverize for fine powder, with breviscapine (in lamp-dish flower acetic) 60g mixing; Other gets PEG-6000 after being heated to fusion in the water-bath, adds said mixture, stirs evenly, and 80-90 ℃ of insulation dissolved in the cold liquid paraffin, and inhale and remove surface liquid paraffin, drying, promptly.Oral, 3 times on the one, one time 12 ball.

Embodiments of the invention 5: get Radix Rhodiolae 1000g, be ground into coarse powder, add 12 times of amount 65% ethanol percolations, percolate reclaims ethanol, add the water boil dissolving after concentrating, filter, filtrate concentrates the back with water saturated equal-volume sec-butyl alcohol extraction 3 times, the reclaim under reduced pressure sec-butyl alcohol, ethanol with the speed eluting of 65% ethanol with per minute 3ml, is reclaimed in the concentrated back of filtrate on polyamide chromatography post, add 5 times of water gagings after eluent concentrates and boil, filtrate is condensed into the dense clear paste that every 1ml is equivalent to medical material 10g, in order to preparation injection, glucose infusion liquid, freeze-dried powder.

The injection preparation: the rhodioside extract adds 1000ml water for injection and stirs evenly, and regulates about pH to 9.0 with sodium hydroxide solution, boils, and filters, and filtrate is regulated about pH to 6.5 with citric acid soln, filters clear and bright; Breviscapine (in lamp-dish flower acetic) 40g adds 1000ml water for injection and stirs evenly, regulate about pH to 7.5 with sodium hydroxide solution, filter clear and brightly, filtrate is mixed with above-mentioned Radix Rhodiolae extract solution, 80 ℃ of heating, activated carbon adsorption 10 minutes, add water to 5000ml, regulate about pH to 6.5, filter, embedding is in the bent neck ampoule of 5ml, promptly.1 5-10ml 1 time on the 1st, faces with preceding adding 100-200ml 5% or 10% glucose injection iv drip.

Glucose infusion liquid prepares: Radix Rhodiolae extract adds 2000ml water for injection and stirs evenly, and regulates about pH to 9.0 with sodium hydroxide solution, boils, and filters, and filtrate is regulated about pH to 6.5 with citric acid soln, filters, and gets Radix Rhodiolae extract solution; Breviscapine (in lamp-dish flower acetic) 40g adds 5000ml water for injection and stirs evenly, and regulates about pH to 7.5 with sodium hydroxide solution, filters, filtrate and above-mentioned Radix Rhodiolae extract solution merge, and regulate about pH6.5 80 ℃ of heating, filtrate for later use is filtered in activated carbon adsorption 10 minutes; After getting the 5000g glucose and adding 30000 waters for injection and boil dissolving, activated carbon adsorption 15 minutes, filtering decarbonization pumps into rare joining in the cylinder after clear and bright, adds above-mentioned Radix Rhodiolae extract and breviscapine filtrate, add water to 100000ml, regulate about pH to 5.3, filter clear and brightly, embedding is in the 100ml infusion bottle, sterilization, promptly.1 100-200ml, intravenous drip, 1 is once.

The freeze-dried powder preparation:

Radix Rhodiolae extract adds 300ml water for injection and stirs evenly, and regulates about pH to 9.0 with sodium hydroxide solution, boils, and filters, and filtrate is regulated about pH to 6.5 with citric acid soln, filters, and gets Radix Rhodiolae extract solution; Breviscapine (in lamp-dish flower acetic) 40g adds 300ml water for injection and stirs evenly, and regulates about pH to 7.5 with sodium hydroxide solution, filters, filtrate and above-mentioned Radix Rhodiolae extract solution merge, and regulate about pH6.5 70-80 ℃ of heating, filtrate for later use is filtered in activated carbon adsorption; Get mannitol 120g and add 600ml water for injection and boil dissolving, activated carbon adsorption 15 minutes, filtering decarbonization adds the above-mentioned mixed liquor of handling well, add the injection water to 2000ml, regulate about pH to 6.5, filters clear and brightly, under aseptic condition, press every bottle of 2ml packing, lyophilization is sealed, promptly.1 1-2 bottle, faces with dissolving in 5% or 10% glucose injection of preceding adding 100ml and dilution back and uses at every day 1 time.

Table 1: this injection is to the influence of experimental dog cerebral ischemia (x ± SD)

Group	Dosage * number of times (mg/kg * c)	Dog number (only)	Full brain heavy (g)	Cerebral ischemia district heavy (g)	Ischemic region weighs/full brain heavy (%)
						This parenteral solution of this parenteral solution of this parenteral solution of control group Shu Xuening injection group group group group rhodiola root group Breviscapinun group	5% glucose injection * 1 0.75 * 1 346.7 * 1 173.4 * 1 86.7 * 1 333.3 * 1 13.3 * 1	6 6 6 6 6 6 6	63.65±5.40 57.82±4.27 60.13±4.20 60.35±5.03 60.47±4.44 61.12±3.65 60.28±6.57	18.90±4.82 9.70±3.07** 12.03±4.74* 14.00±2.53* 15.87±3.55 16.28±2.85 12.80±2.51*	29.50±6.32 16.98±6.07** 19.80±7.54* 23.17±3.54* 26.51±7.06 26.63±4.29 21.61±5.54*

Annotate: each administration group and matched group be * P＜0.05 * * P＜0.01 relatively

Table 2: this injection is to the influence of dog blood flow of middle cerebral artery speed

Group	Dosage * number of times (mg/kg * c)	Dog number (only)	Blood flow rate (cm/s, x ± SD)
							Before the administration		15min after the administration
			Peak velocity	Mean flow rate	Peak velocity	Mean flow rate
							Control group this parenteral solution of this parenteral solution of this parenteral solution of the peaceful injection group of blood group group group rhodiola root group Breviscapinun group of relaxing	5% glucose injection * 1 0.75mg * 1 346.7 * 1 173.4 * 1 86.7 * 1 333.3 * 1 13.3 * 1	6 6 6 6 6 6 6	20.58 ±4.81 21.45 ±6.94 24.47 ±5.47 21.57 ±10.05 17.95 ±9.42 19.98 ±7.33 20.48 ±7.52	9.70 ±1.02 12.43 ±5.05 13.43 ±5.10 11.72 ±6.44 9.83 ±4.67 10.30 ±3.84 11.83 ±4.60	21.38 ±5.01 27.02 ±8.51 31.05* ±7.35 26.82 ±16.46 20.87 ±12.47 24.85 ±9.12 30.75* ±7.48	9.70 ±3.01 17.38** ±5.13 20.27** ±6.20 14.98 ±9.37 11.75 ±6.43 12.05 ±4.28 15.80* ±6.09

Annotate: each administration group and matched group be * P＜0.05 * * P＜0.01 relatively

The influence that this injection of table 3 is tested mice head-breaking global brain ischemia (X ± SD)

Group	Dosage * number of times (mg/kg * c)	Mus number (only)	The number of times (inferior) of dehiscing to breathe
				This parenteral solution of this parenteral solution of this parenteral solution of model group Shu Xuening injection group group group group rhodiola root group Breviscapinun group	5% glucose injection * 5 1.5 * 5 693.4 * 5 346.7 * 5 173.4 * 5 666.7 * 5 26.6 * 5	10 10 10 10 10 10 10	8.70±2.63 11.60±2.17** 12.40±2.63** 11.40±2.32* 10.00±1.83 10.90±0.97* 11.10±3.11

Annotate: administration group and model group be * p＜0.05 * * p＜0.01 relatively

The influence of table 4 pair anesthetized dog ligation LAD myocardial ischemia zymetology index and left ventricle infarction size (X ± SD, N=6)

Group	Dosage (mg/kg)	LDH(U/L)		CPK(U/L)		Left side chamber infarction size (%)
							Before the ligation	After the ligation	Before the ligation	After the ligation
		5% glucose group Shu Xuening injection group red light parenteral solution group rhodiola root group Breviscapinun group	5% glucose injection 0.75 346.7 173.4 86.70 333.3 13.3	43.00± 16.80 48.83±13.48 46.83±16.34 46.83±1.60 44.83±13.57 49.50±24.53 43.33±20.23	335.50±106.27 114.00±19.65** 121.33±18.21** 257.00±55.54 329.33±105.32 256.67±68.58 139.33±18.51**						64.17±13.57 82.00±17.65 97.67±49.73 71.00±21.68 69.83±15.59 75.50±18.51 66.83±11.84	307.17±63.01 139.67±19.53** 204.33±40.71** 218.67±54.80* 264.33±153.32 202.00±50.88** 175.50±63.59**	15.70±2.15 11.04±2.01** 11.76±1.83** 12.85±2.12* 13.56±3.81 13.20±1.81* 11.61±3.15*

Annotate: each administration group and 5% glucose group be * P＜0.05 * * P＜0.01 relatively

The influence of the heart rate of table 5 pair anesthetized dog ligation LAD myocardial infarction and ischemia model (X ± SD, n=6)

Index	Group	Dosage (mg/kg)	Contrast		Ligation LAD increases and decreases ratio
											Before the medicine	15min behind the medicine	5min	10min	15min	30min	60min	120min
			HR (beat/min)	5% glucose group Shu Xuening injection group red light parenteral solution rhodiola root group Breviscapinun group	-- 0.75 346.7 173.4 86.7 333.3 13.3	158.00 ±18.71 183.83 ±17.13 186.00 ±38.75 197.67 ±14.45 175.50 ±31.03 168.00 ±29.11 211.50 ±17.80	171.67 ±26.82 70.90 16.14± 171.33 ±38.89 191.50 ±15.88 168.67 ±29.23 166.83 ±29.07 206.17 ±10.85	0.03 ±0.13 -0.08 ±0.14 -0.07 ±0.07 -0.07 ±0.04 -0.05 ±0.14 -0.10 ±0.09 -0.07 ±0.07	0.01 ±0.11 -0.09 ±0.11 -0.16 ±0.09 -0.10 ±0.07 -0.07 ±0.12 -0.12 ±0.10 -0.12 ±0.07	-0.05 ±0.14 -0.09 ±0.17 -0.12 ±0.09 -0.09 ±0.07 -0.11 ±0.14 -0.14 ±0.09 -0.12 ±0.07									-0.04 ±0.16 -0.10 ±0.19 -0.13 ±0.10 -0.13 ±0.07 -0.14 ±0.13 -0.14 ±0.06 -0.13 ±0.09	-0.05 ±0.12 -0.15 ±0.17 -0.19 ±0.10 -0.20 0.09± -0.17 ±0.14 -0.16 ±0.06 -0.15 ±0.09	-0.11 ±0.16 -0.19 ±0.17 -0.21 ±0.14 -0.18 ±0.08 -0.16 ±0.13 -0.17 ±0.06 -0.15 ±0.11

Annotate: each administration group and 5% glucose group be P＞0.05 relatively

The influence of the average femoral artery pressure of table 6 pair anesthetized dog ligation LAD myocardial infarction and ischemia model (X ± SD, n=6)

Index	Group	Dosage (mg/kg)	Contrast		Increase and decrease ratio behind the ligation LAD
											Before the medicine	15min behind the medicine	5min	10min	15min	30min	60min	120min
			MAP (mmHG)	5% glucose group Shu Xuening injection group red light parenteral solution rhodiola root group Breviscapinun group	-- 0.75 346.7 173.4 86.7 333.3 13.3	79.28 ±38.58 104.56 ±19.48 105.22 ±22.78 106.39 ±16.07 92.72 ±26.18 110.17 ±21.08 105.28 ±17.65	78.89 ±40.26 98.06 ±17.27 103.56 ±22.08 106.06 ±16.21 92.06 ±19.17 94.83 ±13.84 106.89 ±10.50	-0.08 ±0.26 -0.17 ±0.11 -0.05 ±0.06 -0.11 ±0.11 -0.03 ±0.18 -0.10 ±0.09 -0.08 ±0.07	-0.06 ±0.32 -0.18 ±0.11 -0.04 ±0.06 -0.14 ±0.11 -0.04 ±0.16 -0.11 ±0.08 -0.10 ±0.09	-0.16 ±0.23 -0.21 ±0.13 -0.06 ±0.06 -0.10 ±0.08 -0.10 ±0.14 -0.13 ±0.08 -0.12 ±0.09									-0.23 ±0.22 -0.21 ±0.14 -0.09 ±0.07 -0.14 ±0.13 -0.10 ±0.12 -0.17 ±0.06 -0.12 ±0.09	-0.26 ±0.30 -0.28 ±0.25 -0.10 ±0.12 -0.14 ±0.17 -0.13 ±0.12 -0.23 ±0.09 -0.15 ±0.13	-0.29 ±0.30 -0.32 ±0.22 -0.21 ±0.12 -0.20 ±0.16 -0.15 ±0.12 -0.25 ±0.10 -0.15 ±0.23

Annotate: each administration group and 5% glucose group be P＞0.05 relatively

The influence of the epicardial electrogram of table 7 pair anesthetized dog ligation LAD myocardial infarction and ischemia model (X ± SD, n=6)

Index	Group	Dosage (mg/kg)	Contrast		Increase and decrease ratio behind the ligation LAD
											Before the medicine	15min behind the medicine	5min	10min	15min	30min	60min	120min
			EpiECC ST displacement (mv)	5% glucose group Shu Xuening injection group red light parenteral solution rhodiola root group Breviscapinun group	-- 0.75 346.7 173.4 86.7 333.3 13.3	0.09 ±0.05 0.11 ±0.04 0.13 ±0.04 0.16 ±0.09 0.11 ±0.03 0.15 ±0.08 0.10 ±0.03	0.10 ±0.05 0.11 ±0.55 0.12 ±0.04 0.15 ±0.08 0.11 ±0.04 0.14 ±0.07 0.11 ±0.04	0.71 ±2.01 -0.08* ±0.34 0.02* ±0.20 0.32 ±0.55 0.30 ±0.15 0.13* ±0.20 0.23 ±0.27	0.88 ±1.81 0.12** ±0.22 0.20* ±0.10 0.41 ±0.70 0.38 ±0.17 0.14* ±0.44 0.33* 0.28±	0.17 ±0.24 -0.04 ±0.20 0.26 ±0.26 0.17 ±0.31 0.52 ±0.29 0.51 ±1.00 0.16 ±0.46									0.88 ±1.00 0.01 ±0.30 0.07 ±0.15 0.16 ±0.24 0.54 ±0.28 0.42 ±0.79 0.42 ±0.43	0.30 ±1.04 0.08* ±0.30 0.46 ±0.24 0.13 ±0.41 0.72 ±0.25 0.44 ±0.54 0.35 ±0.41	0.79 ±2.18 0.10 ±0.84 0.29 ±0.14 0.28 ±0.37 0.77 ±0.62 0.73 ±1.44 0.49 ±0.69

Annotate: each administration group and 5% glucose group be * P＜0.05 * * P＜0.01 relatively

The table 8 pair kinemic influence of anesthetized dog ligation LAD myocardial infarction and ischemia model (X ± SD, n=6)

Index	Group	Dosage (mg/kg)	Contrast		Increase and decrease ratio behind the ligation LAD
											Before the medicine	15min behind the medicine	5min	10min	15min	30min	60min	120min
			CO (L/min)	5% glucose group Shu Xuening injection group red light parenteral solution rhodiola root group Breviscapinun group	-- 0.75 346.7 173.4 86.7 333.3 13.3	2.17 ±0.31 2.28 ±0.14 2.12 ±0.23 2.24 ±0.25 2.08 ±0.30 2.01 ±0.31 2.05 ±0.30	2.21 ±0.25 2.21 ±0.14 1.93 ±0.24 1.93 ±0.23 1.88 ±0.33 1.83 ±0.32 1.92 ±0.37	-0.10 ±0.13 -0.12 ±0.09 -0.08 ±0.08 -0.07 ±0.03 -0.15 ±0.17 -0.11 ±0.10 -0.13 ±0.05	-0.15 ±0.13 -0.14 ±0.08 -0.18 ±0.05 -0.21 ±0.04 -0.24 ±0.16 -0.19 ±0.05 -0.19 ±0.07	-0.08 ±0.22 -0.09 ±0.16 -0.15 ±0.06 -0.26 ±0.06 -0.32 ±0.15 -0.22 ±0.08 -0.28 ±0.06									-0.02 ±0.27 -0.17 ±0.13 -0.27 ±0.07 -0.31 ±0.09 -0.26 ±0.15 -0.23 ±0.08 -0.18 ±0.09	-0.16 ±0.19 -0.13 ±0.13 -0.29 ±0.03 -0.43 ±0.06 -0.26 ±0.12 -0.13 ±0.07 -0.21 ±0.14	-0.15 ±0.16 -0.15 ±0.13 -0.27 ±0.11 -0.40 ±0.06 -0.24 ±0.14 -0.27 ±0.10 -0.20 ±0.16

Annotate: each administration group and 5% glucose group be P＞0.05 relatively

Table 9 red light injection to the influence of anesthetized dog ligation LAD myocardial ischemia LV+dp/dt (X ± SD, n=6)

Index	Group	Dosage (mg/kg)	Contrast		Ligation LAD increases and decreases ratio
											Before the medicine	15min behind the medicine	5min	10min	15min	30min	60min	120min
			LV+dp/dt (mmHg/sec)	5% glucose group Shu Xuening injection group red light parenteral solution rhodiola root group Breviscapinun group	-- 0.75 346.7 173.4 86.7 333.3 13.3	2112.83 ± 751.45 1581.33 ± 419.65 1615.33 ± 415.79 1433.67 ± 534.45 1327.33 ± 541.79 1865.33 ± 947.44 2120.83 ± 560.66	1621.00 ±375.91 1471.33 ±181.33 1488.50 ±325.83 1370.50 ±602.59 1099.83 ±456.62 1620.17 ±594.92 1930.83 ±279.18	-0.36 ±0.13 -0.17* ±0.18 0.02*** ±0.14 0.11 ±0.65 0.12* ±0.48 -0.24 ±0.29 -0.20 ±0.19	-0.29 ±0.45 -0.14 ±0.09 -0.01* ±0.13 -0.07 ±0.51 0.07 ±0.37 -0.17 ±0.38 -0.22 ±0.22	-0.45 ±0.15 -0.35 ±0.20 -0.08** ±0.14 0.02 ±0.55 0.02* ±0.41 -0.18 ±0.34 -0.20 ±0.25									-0.33 ±0.42 -0.25 ±0.27 -0.04 ±0.15 -0.09 ±0.41 0.07 ±0.35 -0.29 ±0.25 -0.27 ±0.26	-0.37 ±0.23 -0.30 ±0.24 -0.11 ±0.19 0.02 ±0.51 -0.05 ±0.42 -0.29 ±0.34 -0.29 ±0.24	-0.50 ±0.21 -0.34 ±0.12 -0.21 ±0.31 -0.14 ±0.49 -0.09* ±0.29 -0.29 ±0.28 -0.33 ±0.15

Annotate: each administration group and 5% glucose group be * P＜0.05 relatively, * * P＜0.01

Table 10 red light injection to the influence of anesthetized dog ligation LAD myocardial ischemia LV-dp/dt (X ± SD, n=6)

Index	Group	Dosage (mg/kg)	Contrast		Ligation LAD increases and decreases ratio
											Before the medicine	15min behind the medicine	5min	10min	15min	30min	60min	120min
			LV-dp/dt (mmHg/sec)	5% glucose group Shu Xuening injection group red light parenteral solution rhodiola root group Breviscapinun group	-- 0.75 346.7 173.4 86.7 333.3 13.3	1783.17 ± 796.19 1581.33 ± 419.65 1424.50 ± 480.05 1249.17 ± 221.26 1272.00 ± 504.15 1503.17 ± 301.90 1751.83 ± 222.10	1230.50 ±446.25 1471.33 ±181.33 1331.17 ±313.04 1206.50 ±174.55 1135.00 ±319.23 1314.00 ±303.62 1545.83 ±326.84	-0.36 ±0.21 -0.30 ±0.17 -0.05* ±0.22 -0.01* ±0.30 -0.14 ±0.39 -0.25 ±0.28 -0.19 ±0.08	-0.33 ±0.37 -0.17 ±0.17 0.00 ±0.20 0.16 ±0.30 -0.15 ±0.32 -0.29 ±0.21 -0.27 ±0.08	-0.44 ±0.27 -0.38 ±0.19 -0.14* ±0.13 -0.15 ±0.26 -0.14 ±0.33 -0.26 ±0.22 -0.26 ±0.14									-0.27 ±0.56 -0.28 ±0.27 0.01 ±0.16 -0.26 ±0.23 -0.13 ±0.32 -0.32 ±0.25 -0.32 ±0.18	-0.36 ±0.27 -0.30 ±0.30 -0.07 ±0.37 -0.22 ±0.28 -0.17 ±0.37 -0.38 ±0.30 -0.36 ±0.13	-0.50 ±0.30 -0.58 ±0.46 -0.19 ±0.50 -0.26 ±0.19 -0.23 ±0.30 -0.42 ±0.21 -0.45 ±0.07

Annotate: each administration group and 5% glucose group be * P＜0.05 relatively,

Table 11 red light injection to the influence of anesthetized dog ligation LAD myocardial infarction and ischemia model LVP (X ± SD, n=6)

Index	Group	Dosage (mg/kg)	Contrast		Increase and decrease ratio behind the ligation LAD
											Before the medicine	15min behind the medicine	5min	10min	15min	30min	60min	120min
			LVP (mmHg)	5% glucose group Shu Xuening injection group red light parenteral solution rhodiola root group Breviscapinun group	-- 0.75 346.7 173.4 86.7 333.3 13.3	60.30 ±15.50 70.90 ±16.14 67.30 ±12.52 63.60 ±13.41 55.40 ±17.65 76.63 ±9.95 78.90 ±10.79	57.18 ±13.35 68.00 ±14.55 60.83 ±7.17 61.93 ±15.72 49.90 ±13.77 70.43 ±15.26 67.87 ±11.47	-0.06 ±0.16 -0.19 ±0.22 -0.05 ±0.18 -0.02 ±0.28 -0.05 ±0.36 -0.19 ±0.23 -0.26* ±0.13	-0.18 ±0.13 -0.20 ±0.19 -0.03 ±0.11 -0.12 ±0.29 -0.05 ±0.30 -0.16 ±0.23 -0.27 ±0.18	-0.20 ±0.13 -0.30 ±0.17 -0.04* ±0.09 -0.11 ±0.27 -0.06 ±0.30 -0.19 ±0.20 -0.30 ±0.21									-0.23 ±0.14 -0.30 ±0.21 -0.03** ±0.07 -0.16 ±0.24 -0.07 ±0.26 -0.23 ±0.18 -0.33 ±0.20	-0.24 ±0.20 -0.34 ±0.16 -0.05 ±0.14 -0.14 ±0.25 -0.09 ±0.31 -0.30 ±0.25 -0.43 ±0.25	-0.27 ±0.13 -0.35 ±0.13 -0.15 ±0.24 -0.12 ±0.15 -0.10 ±0.22 -0.35 ±0.15 -0.37 ±0.37

Annotate: each administration group and 5% glucose group be * P＜0.05 relatively, * * P＜0.01

Table 12 red light injection to the influence of anesthetized dog ligation LAD myocardial infarction and ischemia model LVEDP (X ± SD, n=6)

Index	Group	Dosage (mg/kg)	Contrast		Increase and decrease ratio behind the ligation LAD
											Before the medicine	15min behind the medicine	5min	10min	15min	30min	60min	120min
			LVEDP (mmHg)	5% glucose group Shu Xuening injection group red light parenteral solution rhodiola root group Breviscapinun group	-- 0.75 346.7 173.4 86.7 333.3 13.3	3.62 ±1.67 4.25 ±1.48 3.12 ±1.55 3.20 ±1.04 3.48 ±1.96 4.78 ±1.27 4.53 ±1.85	3.05 ±2.05 4.13 ±1.11 3.43 ±2.17 3.40 ±0.86 3.37 ±1.62 4.42 ±1.32 4.02 ±1.41	0.75 ±1.66 0.29 ±0.57 -0.17 ±0.46 0.14 ±0.20 0.09 ±0.41 -0.08 ±0.25 -0.14 ±0.42	-0.02 ±0.78 0.26 ±0.51 -0.13 ±0.32 0.13 ±0.15 0.06 ±0.32 -0.14 ±0.23 -0.21 ±0.42	0.02 ±0.78 0.55 ±1.03 -0.04 ±0.28 0.26 ±0.32 0.09 ±0.29 -0.01 ±0.24 -0.15 ±0.37									0.10 ±0.85 0.13 ±0.28 -0.22 ±0.22 0.14 ±0.29 -0.02 ±0.27 -0.05 ±0.18 -0.19 ±0.48	1.07 ±1.88 0.09 ±0.35 -0.20 ±0.21 0.22 ±0.47 0.12 ±0.43 -0.01 ±0.17 -0.03 ±0.70	0.56 ±0.86 0.42 ±0.98 0.25 ±0.37 -0.14 ±0.49 0.58 ±0.82 0.39 ±0.19 0.19 ±0.69

Annotate: each administration group and 5% glucose group be * P＜0.05 relatively

Table 13 red light injection to the influence of anesthetized dog ligation LAD myocardial ischemia oxygen consumption index (X ± SD, n=6)

Index	Group	Dosage (mg/kg)	Contrast		Increase and decrease ratio behind the ligation LAD
											Before the medicine	15min behind the medicine	5min	10min	15min	30min	60min	120min
			MVO 2 (mlO 2/ min/100g)	5% glucose group Shu Xuening injection group red light parenteral solution rhodiola root group Breviscapinun group	-- 0.75 346.7 173.4 86.7 333.3 13.3	12.64 ±4.65 17.43 ±2.85 17.29 ±3.22 18.85 ±2.29 15.31 ±4.51 16.04 ±3.34 18.76 ±2.99	13.29 ±4.62 15.09 ±2.14 15.81 ±3.04 17.59 ±2.17 13.96 ±2.85 14.07 ±2.62 18.16 ±1.75	-0.03 ±0.07 -0.22* ±0.16 -0.09 ±0.07 -0.14 ±0.12 -0.11 ±0.16 -0.16* ±0.11 -0.13 ±0.12	-0.01 ±0.13 -0.21* ±0.16 -0.17** ±0.03 -0.20** 0.09± -0.14 ±0.13 -0.19* ±0.11 -0.18* ±0.14	-0.10 ±0.10 -0.22 ±0.24 -0.16* ±0.04 -0.20 ±0.09 -0.21 ±0.16 -0.23* ±0.08 -0.22 ±0.13									-0.14 ±0.14 -0.26 ±0.23 -0.26* ±0.05 -0.25 ±0.10 -0.25 ±0.12 -0.29* ±0.06 -0.25 ±0.14	-0.18 ±0.25 -0.32 ±0.28 -0.28 ±0.08 -0.33 ±0.14 -0.31 ±0.12 -0.38 ±0.05 -0.28 ±0.16	-0.26 ±0.22 -0.37 ±0.21 -0.34 ±0.12 -0.36 ±0.13 -0.35 ±0.10 -0.40 ±0.08 -0.28 ±0.25

Annotate: compare * P＜0.05 * * P＜0.01 with 5% glucose group

Table 14 red light injection is to the influence of the open number of Mice Auricle point of intersect of the capillary network (x ± SD)

Group	Dosage (mg/kg)	Mus number (only)	The open number (individual/visual field) in auricular microcirculation blood capillary site
								Before the injection Adr	1min behind the injection Adr	5min behind the injection Adr	10min behind the injection Adr	15min behind the injection Adr
			The high rhodiola root group of control group model group Shu Xuening injection group red light parenteral solution Breviscapinun group	-- -- 1.5 693.3 346.7 173.4 666.6 26.6	10 10 10 10 10 10 10 10	18.2±2.66 19.7±3.13 20.2±1.81 22.1±2.60 21.8±2.97 21.3±3.40 20.8±2.97 19.4±2.63	17.8±2.74 9.9±2.51 △△ 14.1±2.64** 12.4±1.90* 12.3±1.49* 10.5±1.35 12.9±1.20** 14±1.49**						18.4±2.63 12.9±2.02 △△ 17.5±1.90** 14.8±1.32* 15±1.56* 13.4±2.12 16.1±1.29** 16.6±0.97**	18±2.40 15.7±2.50 △ 19.5±1.65** 20.4±1.71** 18.5±2.12* 18.5±2.2* 18.8±1.93** 17.9±1.91*	17.9±2.33 18.4±1.43 19.5±1.65 20.4±1.71* 18.5±2.12 19.3±1.94 19±2.45 17.9±1.91

Annotate: 1. model group and matched group compare △ P＜0.05 △ △ P＜0.01

2. each administration group and model group compare * P＜0.05 * * P＜0.01

Table 15 red light injection is to the influence of Mice Auricle microcirculation velocity of blood flow

Group	Dosage (mg/kg)	Mus number (only)	The auricular microcirculation velocity of blood flow (μ m/s, x ± SD)
								Before the injection Adr	1min behind the injection Adr	5min behind the injection Adr	10min behind the injection Adr	15min behind the injection Adr
			The high rhodiola root group of control group model group Shu Xuening injection group red light parenteral solution Breviscapinun group	-- -- 1.5 693.3 346.7 173.4 666.6 26.6	10 10 10 10 10 10 10 10	705.7±46.76 701.7±36.19 694.6±54.05 729.0±53.35 699.4±54.15 681.1±43.94 675.7±53.91 673.4±59.64	706.5±40.95 336.2±64.96 △△ 393.4±83.78 407.6±114.65 390.1±55.58 381.0±56.04 383.1±69.47 377.2±49.2						704.5±46.46 389.4±65.58 △△ 467.3±81.62** 485.4±66.68** 503.2±412.2* 455.9±49.99* 446.5±55.4* 448.2±43.58*	707.2±42.87 468.5±60.75 △△ 541.5±67.19* 560.2±45.03** 563.6±44.76** 555.1±37.31** 540.5±51.96* 536.1±41.09**	709.6±44.51 596.0±41.31 △△ 636.0±51.07 644.8±48.9* 650.6±48.50* 627.9±32.88 635.1±58.1 633.6±40.07

Annotate: 1. model group and matched group compare △ P＜0.05 △ △ P＜0.01

2. each administration group and model group compare * P＜0.05 * * P＜0.01

Table 16 red light injection is to the influence of Mice Auricle microcirculation blood fluidised form

Group	Dosage (mg/kg)	Mus number (only)	Auricular microcirculation blood fluidised form (divide, x ± SD)
								Before the injection Adr	1min behind the injection Adr	5min behind the injection Adr	10min behind the injection Adr	15min behind the injection Adr
			The high rhodiola root group of control group model group Shu Xuening injection group red light parenteral solution Breviscapinun group	-- -- 1.5 693.3 346.7 173.4 666.6 26.6	10 10 10 10 10 10 10 10	0.00±0.00 0.00±0.00 0.00±0.00 0.00±0.00 0.00±0.00 0.00±0.00 0.00±0.00 0.00±0.00	0.00±0.00 2.80±0.42 △△ 2.00±0.00** 1.90±0.32** 2.30±0.48* 2.70±0.48 1.70±0.48** 1.60±0.52**						0.00±0.00 2.40±0.52 △△ 1.70±0.48** 1.80±0.42* 2.00±0.00* 1.80±0.42* 1.40±0.52** 1.20±0.42**	0.00±0.00 1.50±0.71 △△ 1.00±0.00* 1.00±0.00* 1.00±0.00* 1.00±0.00* 1.00±0.00* 1.00±0.00*	0.00±0.00 0.40±0.52 △ 0.00±0.00* 0.00±0.00* 0.20±0.42 0.30±0.48 0.1±0.32 0.00±0.00*

Annotate: 1. model group and matched group compare △ P＜0.05 △ △ P＜0.01

2. each administration group and model group compare * P＜0.05 * * P＜0.01

Table 17 red light injection is to the influence of Mice Auricle microcirculation microcirculation third level arteries caliber

Group	Dosage (mg/kg)	Mus number (only)	Auricular microcirculation third level arteries caliber (μ m, x ± SD)
								Before the injection Adr	1min behind the injection Adr	5min behind the injection Adr	10min behind the injection Adr	15min behind the injection Adr
			The high rhodiola root group of control group model group Shu Xuening injection group red light parenteral solution Breviscapinun group	-- -- 1.5 693.3 346.7 173.4 666.6 26.6	10 10 10 10 10 10 10 10	15.32±2.38 16.78±1.47 16.40±1.48 16.33±1.18 16.22±1.87 17.10±1.33 16.69±1.30 16.27±0.88	15.55±2.27 10.40±2.07△△ 12.01±0.94* 13.02±0.73** 11.80±2.06 12.44±2.19* 12.98±1.61** 11.91±1.35						15.48±2.00 11.13±1.51△△ 13.89±1.14** 14.45±0.97** 13.15±1.58* 13.80±1.55** 14.83±0.81** 13.04±1.16**	15.28±2.39 12.98±0.71△ 14.71±0.77* 15.18±0.81** 15.2±0.91** 15.78±0.91** 14.83±0.82** 15.07±1.2**	15.41±2.38 15.20±1.62 15.51±1.52 15.65±0.88* 15.46±0.76 16.14±0.85 14.75±1.34 15.38±0.72

Annotate: 1. model group and matched group compare △ P＜0.05 △ △ P＜0.01 2. each administration group and model group comparison * P＜0.05 * * P＜0.01

Table 18 red light injection is to the influence of Mice Auricle microcirculation third level vein blood vessel caliber

Group	Dosage (mg/kg)	Mus number (only)	Auricular microcirculation third level vein blood vessel caliber (μ m, x ± SD)
								Before the injection Adr	1min behind the injection Adr	5min behind the injection Adr	10min behind the injection Adr	15min behind the injection Adr
			The high rhodiola root group of control group model group Shu Xuening injection group red light parenteral solution Breviscapinun group	-- -- 1.5 693.3 346.7 173.4 666.6 26.6	10 10 10 10 10 10 10 10	22.24±1.51 22.49±1.93 23.86±1.56 22.28±1.37 22.25±1.74 22.58±2.01 22.37±1.50 22.02±1.52	21.96±1.54 12.16±1.82 △△ 15.09±1.41** 15.01±1.04** 14.76±1.32** 14.67±0.77** 14.47±1.13** 14.42±0.98**						21.99±1.57 14.20±1.89 △△ 16.74±1.36** 16.50±1.05** 16.79±1.27** 16.71±0.98** 15.57±0.74* 16.93±0.91**	22.08±1.39 18.90±1.79 △△ 20.91±2.00* 20.40±0.83* 20.49±1.52* 20.21±0.78* 20.64±1.00* 20.33±0.99*	22.11±1.40 19.58±1.60 △△ 21.89±1.66** 22.10±0.93** 22.10±1.43** 20.95±0.84* 21.39±0.69** 20.98±0.77*

Annotate: 1. 2. each administration group and model group comparison of model group and matched group comparison △ P＜0.05 △ △ P＜0.01 ^*P＜0.05 ^*P＜0.01

This injection of table 19 is to the dissolved influence of rabbit pulmonary thrombosis (X ± SD)

Group	Drug dose (mg/kg)	Rabbit number (only)	Wet weight of thrombus (mg)		Thrombosis dry weight (mg) after the administration
						Before the administration	After the administration
			This injection of matched group urokinase group Radix Rhodiolae group breviscapine group	-- 1000u 693.3 346.7 173.4 666.6 26.6				8 8 8 8 8 8 8	300.49±1.37 299.89±1.25 299.94±1.46 299.86±1.16 299.48±1.45 300.15±1.27 300.33±0.98	147.91±8.10 56.66±4.05** 72.51±6.95** 105.96±8.02** 114.84±5.25** 125.23±6.78** 63.36±6.49**	47.58±4.36 18.51±2.09** 20.21±4.60** 30.45±4.47** 33.60±5.07** 35.49±4.98** 21.71±4.27**

Annotate: each administration group and 5% glucose injection group be * P＜0.05 relatively, * * P＜0.01

This injection of table 20 is to the influence of fibrinolysis time (X ± SD)

Group	Dosage * sky (mg/kg * d)	Rabbit number (only)	Fibrinolysis time (min)
				Blank this injection of group urokinase group Radix Rhodiolae group breviscapine group	-- 1000u×7 693.3×7 346.7×7 173.4×7 666.6×7 26.6×7	8 8 8 8 8 8 8	246.25±38.89 65.00±25.63*** 131.25±62.21*** 112.50±58.49*** 107.50±55.493*** 90.00±25.63*** 112.50±41.32***

Annotate: each administration group and matched group be * * * P＜0.001 relatively

This injection of table 21 is to the influence of deficiency of vital energy mice swimming time (resisting fatigue) (X ± SD)

Group	Dosage * sky (mg/kg * d)	Mus number (only)	Swimming time (s)
				Blank this parenteral solution of group model group ginseng aconite injection agent group group rhodiola root group Breviscapinun group	5% glucose * 7 5% glucose * 7 6.67ml * 7 693.3 * 7 346.7 * 7 173.4 * 7 666.6 * 7 26.6 * 7	10 10 10 10 10 10 10 10	350.90±22.88 92.10±28.58△△△ 127.00±21.06** 123.80±24.22** 117.20±25.52* 89.90±17.91 119.60±22.25* 96.20±26.89

Annotate: 1. model group and normal control group comparison △ △ △ p＜0.001 2. administration group and matched group compare * p＜0.05 * * p＜0.01

This injection of table 22 is to the influence of deficiency of vital energy mice normal pressure resistant anoxia (x ± SD)

Group	Dosage * sky (mg/kg * d)	Mus number (only)	Death time (min)	Rate elongation (%)
					5% this parenteral solution of glucose group model group ginseng aconite injection agent group group rhodiola root group Breviscapinun group	5% glucose * 7 5% glucose * 7 6.67m1 * 7 693.3 * 7 346.7 * 7 173.4 * 7 666.6 * 7 26.6 * 7	10 10 10 10 10 10 10 10	40.80±5.88 30.50±9.02△△△ 41.50±9.02** 38.10±6.97** 34.20±6.25 31.40±5.15 36.50±4.20** 33.00±4.24	- - 36.07 24.92 12.13 2.95 19.67 8.20

Annotate: 1. model group and 5% glucose group comparison △ △ △ p＜0.001 2. administration group and model group compare * * p＜0.01

Claims (14)

1, the Chinese medicine preparation that is used for the treatment of cardiovascular and cerebrovascular disease is characterized in that calculating according to components by weight percent: the raw material of making this Chinese medicine preparation active ingredient is: Radix Rhodiolae 600-1400 part and breviscapine 20-60 part, wherein breviscapine is in lamp-dish flower acetic.

2, according to the described Chinese medicine preparation that is used for the treatment of cardiovascular and cerebrovascular disease of claim 1, it is characterized in that calculating according to components by weight percent: it is prepared from by 1000 parts of Radix Rhodiolaes and 40 parts of breviscapines and adjuvant, and wherein breviscapine is in lamp-dish flower acetic.

3, according to the described Chinese medicine preparation that is used for the treatment of cardiovascular and cerebrovascular disease of claim 2, it is characterized in that described adjuvant not being all: sucrose, dextrin, starch, polyacrylic resin, micropowder silica gel, carboxymethyl starch sodium, magnesium stearate, PEG-6000, mannitol according to dosage form.

4, according to claim 1 or the 2 described Chinese medicine preparation that are used for the treatment of cardiovascular and cerebrovascular disease, it is characterized in that: the dosage form of described preparation is granule, hard capsule, soft capsule, tablet, drop pill, oral liquid, injection, slow releasing preparation, controlled release preparation.

5,, it is characterized in that described injection is: injection, glucose infusion liquid, freeze-dried powder according to the described Chinese medicine preparation that is used for the treatment of cardiovascular and cerebrovascular disease of claim 4.

6, as the described preparation method that is used for the treatment of the Chinese medicine preparation of cardiovascular and cerebrovascular disease of arbitrary claim among the claim 1-5, it is characterized in that: after Radix Rhodiolae being adopted the method effective component extracting of decocting in water or percolation, add breviscapine and adjuvant again, be prepared into different preparations.

7, according to the described preparation method that is used for the treatment of the Chinese medicine preparation of cardiovascular and cerebrovascular disease of claim 6, it is characterized in that: get Radix Rhodiolae and decoct with water 2 times, merge 2 times decocting liquid, filter, filtrate decompression is condensed into clear paste, adds breviscapine and sucrose, dextrin, mixing, granulate, sieve drying, granulate, packing promptly gets granule.

8, according to the described preparation method that is used for the treatment of the Chinese medicine preparation of cardiovascular and cerebrovascular disease of claim 6, it is characterized in that: get Radix Rhodiolae and decoct with water 2 times, merge 2 times decocting liquid, filter, filtrate decompression is condensed into clear paste, spray drying, add breviscapine and starch, mixing is granulated, sieve, drying, granulate, coating, packing promptly gets capsule.

9, according to the described preparation method that is used for the treatment of the Chinese medicine preparation of cardiovascular and cerebrovascular disease of claim 6, it is characterized in that: get Radix Rhodiolae and decoct with water 2 times, merge 2 times decocting liquid, filter, filtrate decompression is condensed into clear paste, spray drying, add breviscapine and micropowder silica gel, mixing is granulated, sieve drying, granulate, add carboxymethyl starch sodium and magnesium stearate, mixing, tabletting, the bag film-coat promptly gets tablet.

10, according to the described preparation method that is used for the treatment of the Chinese medicine preparation of cardiovascular and cerebrovascular disease of claim 6, it is characterized in that: get Radix Rhodiolae, be ground into coarse powder, add ethanol percolation, percolate reclaims ethanol, add the water boil dissolving after concentrating, filter, filtrate concentrates the back with water saturated equal-volume sec-butyl alcohol extraction 3 times, the reclaim under reduced pressure sec-butyl alcohol, filtrate is concentrated into dried, pulverizes to be fine powder, with the breviscapine mixing; Other gets PEG-6000 after being heated to fusion in the water-bath, adds said mixture, stirs evenly, and 80-90 ℃ of insulation dissolved in the cold liquid paraffin, inhales and removes surface liquid paraffin, and drying promptly gets drop pill.

11, according to the described preparation method that is used for the treatment of the Chinese medicine preparation of cardiovascular and cerebrovascular disease of claim 6, it is characterized in that: get Radix Rhodiolae, be ground into coarse powder, add ethanol percolation, percolate reclaims ethanol, add the water boil dissolving after concentrating, filter, filtrate concentrates the back with water saturated equal-volume sec-butyl alcohol extraction 3 times, the reclaim under reduced pressure sec-butyl alcohol, ethanol with ethanol elution, is reclaimed in the concentrated back of filtrate on polyamide chromatography post, eluent adds water boil after concentrating, filtrate is condensed into dense clear paste, get Radix Rhodiolae extract, add breviscapine and adjuvant again, can make injection.

12, according to claim 6 or the 11 described preparation methoies that are used for the treatment of the Chinese medicine preparation of cardiovascular and cerebrovascular disease, it is characterized in that: Radix Rhodiolae extract adds the injection water and stirs evenly, regulate pH to 9.0 with sodium hydroxide solution, boil, filter, filtrate is regulated pH to 6.5 with citric acid soln, filters clear and bright, must Radix Rhodiolae extract solution; Breviscapine adds the injection water and stirs evenly, and regulates pH to about 7.5 with sodium hydroxide solution, filters clear and brightly, and filtrate is mixed with above-mentioned Radix Rhodiolae extract solution, heat, and activated carbon adsorption, adjusting pH to 6.5, filtration, embedding promptly gets injection.

13, according to claim 6 or the 11 described preparation methoies that are used for the treatment of the Chinese medicine preparation of cardiovascular and cerebrovascular disease, it is characterized in that: Radix Rhodiolae extract adds the injection water and stirs evenly, regulate pH to 9.0 with sodium hydroxide solution, boil, filter, filtrate is regulated pH to 6.5 with citric acid soln, filters, and gets Radix Rhodiolae extract solution; Breviscapine adds the injection water and stirs evenly, and regulates pH to 7.5 with sodium hydroxide solution, filters, and filtrate and Radix Rhodiolae extract solution merge, and regulate pH6.5, heating, and filtrate for later use is filtered in activated carbon adsorption; After getting glucose and adding injection water boils dissolving, activated carbon adsorption, filtering decarbonization pumps into rare joining in the cylinder after clear and bright, add above-mentioned Radix Rhodiolae extract and breviscapine filtrate, add the injection water, regulate pH to 5.3, filter clear and bright, embedding, sterilization promptly gets glucose infusion liquid.

14, according to claim 6 or the 11 described preparation methoies that are used for the treatment of the Chinese medicine preparation of cardiovascular and cerebrovascular disease, it is characterized in that: Radix Rhodiolae extract adds the injection water and stirs evenly, regulate pH to 9.0 with sodium hydroxide solution, boil, filter, filtrate is regulated pH to 6.5 with citric acid soln, filters, and gets Radix Rhodiolae extract solution; Breviscapine adds the injection water and stirs evenly, and regulates pH to 7.5 with sodium hydroxide solution, filters, and filtrate and Radix Rhodiolae extract solution merge, and regulate pH6.5, heating, and filtrate for later use is filtered in activated carbon adsorption; Get mannitol and add the injection water and boil dissolving, activated carbon adsorption, filtering decarbonization adds the above-mentioned mixed liquor of handling well, adds the injection water, and adjusting pH to 6.5 filters clear and brightly, aseptic subpackaged, and lyophilization is sealed, and promptly gets freeze-dried powder.