CN1935198A - Chinese medicine compound preparation and its preparing method - Google Patents

Abstract

The present invention relates to a Chinese medicine compound preparation for curing angiocardiopathy and cerebrovascular disease. The prescription of said Chinese medicine compound preparation is formed from ginseng (or ginseng steam and leaf portion or red ginseng or pilose asiabell root) or its extract and red peony (or white peony) or its extract. It can be made into injection preparation and various oral preparalans, and can be mainly used for curing the diseases of coronary heart disease, angina pectoris and myocardial ischemia, etc.

Description

A kind of compound Chinese medicinal preparation and preparation method thereof

Technical field

The present invention relates to a kind of compound Chinese medicinal preparation that is used for the treatment of cardiovascular and cerebrovascular disease, the preparation method of this compound preparation is provided simultaneously, belong to technical field of Chinese medicine.

Technical background

Cardiovascular and cerebrovascular disease is first of current serious threat human life and the healthy major disease, has become first and second cause of death of world's most countries, and it not only has very high fatality rate, and causes patient's disability rate also high after its morbidity.There is 2,600,000 people every year in China because of cardiovascular and cerebrovascular disease death at present, and therefore plant disease and death with regard to 1 people is arranged per 12 seconds, and wherein coronary heart disease ranks first.It is reported that coronary heart disease has become the important diseases that threatens public's life and health, China dies from the number of various coronary heart disease every year and estimates to surpass 1,000,000.One studies show that, in 10 years, China's males with coronary disease sickness rate will increase by 26.1%, and the women will increase by 19.0%.And the evidence of coronary heart diseases mortality rate is still in rapid rising.At present, the nitrate preparations of clinical Western medicine that is used for coronary heart disease treatment such as nitroglycerin, sorbitrate, 5-single nitric acid sorbitol etc.; Adrenergic such as Propranolol, oxprenolol, alprenolol, pindolol, metoprolol; Calcium channel blocker such as verapamil, nifedipine, diltiazem; Antiplatelet drug such as aspirin, dipyridamole, benzene sulphur azoles sulphur; Adjust hypolipidemic medicine such as nicotinic acid, pravastatin, lovastatin; Thrombolytic agent such as warfarin, heparin, urokinase, streptokinase; But find in the medication process that this type of medicine can be alleviated acute symptom, but the cause of disease is still lacked effective treatment means, and with certain toxic and side effects; And Chinese medicine such as FUFANG DANSHEN DIWAN, FUFANG DANSHEN PIAN, SUXIAO JIUXIN WAN, Heart pill of Musk etc. have demonstrated certain advantage, but it is low to exist bioavailability mostly, and onset is slow, prescription complexity, drawback such as dose is big.So develop prevention and treatment cardiovascular and cerebrovascular disease especially treating coronary heart disease and angina pectoris become the serious and difficult task of pendulum in face of ours.

Coronary heart disease is a kind of because coronary artery stationarity (atheroma sclerosis) or dynamic property (vasospasm) pathological changes, cause the narrow even obstruction of vessel lumen, cause that the myocardial oxygen need are unbalance and cause myocardial ischemia-anoxemia or downright bad a kind of heart disease, also claim ischemic heart desease.Coronary heart disease belongs to categories such as the traditional Chinese medical science " thoracic obstruction ", " pained ", " angina pectoris ", the traditional Chinese medical science thinks that the pathogenesis of coronary heart disease is a deficiency in origin and excess in superficiality, so-called deficiency in origin mainly refers to the void thanks to of the heart, spleen, kidney yin kidney yang QI and blood, the real mainly finger of the so-called mark stagnation of QI, blood stasis, turbid, the YIN-cold of expectorant.So according to the pathogenesis of coronary heart disease deficiency in origin and excess in superficiality. nourishing-to-relaxing is emphasized in treatment by Chinese herbs, and the invigorating middle warmer residence is logical, and through-supplementation is conceived to the adjusting of allomeric function, and reaching gas, to be full of blood capable, the blood vessels tonneau.Simultaneously compare Chinese medicine coronary heart disease with Western medicine, have following advantage: toxic and side effects is less relatively, is suitable for prolonged application; Can act on a plurality of pathology links; To improve that the patient follows as breathe hard, symptom such as weak, spirit depressing and sexual hypofunction is comparatively obvious; Clinical and experimentation shows that Chinese medicine coronary heart disease has coronary artery dilator, improves myocardial ischemia, suppresses platelet aggregation, improves effects such as patient moving ability and quality of life.So, defective that exists at prior art and Chinese medicine excavate motherland's medical treasure-house in the unique advantage of such disease of treatment, and it is capable and vigorous to seek a kind of prescription, determined curative effect, the pure Chinese medicinal preparation that is used for the treatment of as cardiovascular and cerebrovascular diseases such as angina pectoris that has no side effect just seems very urgent.

Summary of the invention

The objective of the invention is to disclose a kind of compound Chinese medicinal preparation for the treatment of cardiovascular and cerebrovascular disease, the employing people participates in Radix Paeoniae Rubra (or Radix Paeoniae Alba) or its extract formula is made the preparation that needs; The traditional Chinese medical science thinks that the generation of coronary heart disease is many, and function is deficient because worn with age, yin and yang qi and blood disorder, and the influence of seven emotions six climate exopathogens causes qi depression to blood stasis in addition, and hypofunction of YANG QI in chest is given birth in expectorant is turbid, makes blockage of the cardiac vessels, stagnation of QI and blood may bring about pain.In view of the above as can be known, blood stasis due to qi deficiency be coronary heart disease main diseases because of.According to the pathogenesis of coronary heart disease deficiency in origin and excess in superficiality, nourishing-to-relaxing is emphasized in treatment by Chinese herbs, and invigorating middle warmer residence is logical, and through-supplementation is conceived to the adjusting of allomeric function, and reaching gas, to be full of blood capable, the blood vessels tonneau.Prescription of the present invention, Radix Ginseng has strongly invigorating primordial QI, strengthening by means of tonics, the Fructus Alpiniae Oxyphyllae of calming the nerves is promoted the production of body fluid, and answers effects such as arteries and veins takes off admittedly.Modern pharmacological research also shows, Radix Ginseng has pharmacological action widely to cardiovascular system: reduce the arterial pressure resistance, decreased heart rate, strengthen myocardial hypoxia tolerance, supraventricular tachycardia threshold value due to the rising intracardiac electrode pace-making, significantly improve cardiac muscle to anoxybiotic tolerance, arrhythmia, reduce blood cholesterol, coronary artery dilating increases effects such as coronary blood flow, antiplatelet aggregation, and old friend's ginseng has certain preventive and therapeutic effect to common Senile disease such as hypertension, atherosclerosis, coronary heart disease, as monarch drug, originally with the treatment deficiency of vital energy; Radix Paeoniae Rubra has the animal of increasing coronary flow, anti-platelet aggregation, antithrombotic formation, atherosclerosis, anti-experimental character myocardial ischemia, microcirculation improvement and reduces the portal hypertension effect; to the damage of rat neurocyte cerebral ischemia sample, significant protective effect is arranged all.The clinical premonitory apoplexy, cerebral infarction, acute cerebral thrombosis of being used for the treatment of forms, and in order to ministerial drug, the principal drug assistance blood circulation promoting and blood stasis dispelling has the effect of eliminating stasis to stop pain simultaneously.The results of pharmacodynamic test of prescription proportioning shows that Radix Ginseng and Radix Paeoniae Rubra two medicines share, and have stronger physiologically active.Another object of the present invention is to disclose the preparation of drug combination method of this treatment cardiovascular and cerebrovascular disease, comprise multiple injection type and peroral dosage form, effectively avoid the single inconvenience that brings of dosage form of present doctors and patients' medication, satisfied the selection of clinician and extensive patients to a greater degree.

Preparation of the present invention is to constitute like this: calculate according to composition by weight, it is made by 1～99 part of Radix Ginseng and 99～1 parts of Radix Paeoniae Rubra or by the Radix Ginseng extract and the Radix Paeoniae Rubra extract that obtains behind extraction separation of corresponding weight portion Radix Paeoniae Rubra of corresponding weight portion Radix Ginseng through obtaining behind the extraction separation.Specifically, calculate according to composition by weight, it is made by 10～80 parts of Radix Ginsengs and 90～20 parts of Radix Paeoniae Rubra or by the Radix Ginseng extract and the Radix Paeoniae Rubra extract that obtains behind extraction separation of corresponding weight portion Radix Paeoniae Rubra of corresponding weight portion Radix Ginseng through obtaining behind the extraction separation.Say more specifically, calculate that it is made by 30～60 parts of Radix Ginsengs and 70～40 parts of Radix Paeoniae Rubra or by the Radix Ginseng extract and the Radix Paeoniae Rubra extract that obtains of corresponding weight portion Radix Paeoniae Rubra of corresponding weight portion Radix Ginseng through obtaining behind the extraction separation behind extraction separation according to components by weight percent.

Preparation of the present invention is injection and oral formulations; Injection comprises: be directly used in drug administration by injection injection, need to be used for the concentrated solution for injection of intravenous drip after the dilution, directly for the venous transfusion of intravenous drip and injectable sterile powder and the aseptic block that makes with freeze-drying or spray drying method; Oral formulations comprises: all acceptable dosage forms on tablet, dispersible tablet, effervescent tablet, oral cavity disintegration tablet, capsule, soft capsule, microcapsule, granule, pill, powder, drop pill, slow releasing preparation, controlled release preparation, oral liquid, soft extract, extractum, gel, membrane and other pharmaceuticss.Particularly preferred dosage form is the injection that is directly used in drug administration by injection, need to be used for the concentrated solution for injection of intravenous drip after the dilution, directly for the venous transfusion of intravenous drip and injectable sterile powder and aseptic block, drop pill, capsule, soft capsule, oral cavity disintegration tablet, tablet, pellet, dispersible tablet or the granule that makes with freeze-drying or spray drying method.

Described preparation calculates according to percentage by weight, and the content of ginsenoside's constituents is not less than 1% of the total solid after the deduction adjuvant amount and water quantities in the preparation; Content of paeoniflorin is not less than in the preparation 0.1% of total solid after deduction adjuvant amount and the water quantities; Derive from the injection Radix Ginseng saponin component, all can be surveyed the component content sum and are not less than 25% of the total solid after the deduction adjuvant amount and water quantities in the preparation to derive from the glycoside composition of Radix Paeoniae Rubra and other.

The preparation method of preparation of the present invention is: get Radix Ginseng, Radix Paeoniae Rubra medical material, add water or ethanol extraction respectively, extracting solution through suitably concentrate the medical material crude extract, one or more that further adopt water precipitating, precipitate with ethanol, organic solvent extractionprocess, flocculent precipitation, column chromatography unite use carry out suitably refining, get the extract of Radix Ginseng and Radix Paeoniae Rubra medical material respectively, with ginseng crude drug's the crude extract or the crude extract or the extract mixing of extract and Radix Paeoniae Rubra medical material, add adjuvant and be prepared into different preparations with diverse ways.

The preparation method of described preparation, specifically be: get the ginseng crude drug, add 5～15 times of volume 50～80% alcohol reflux 1～4 time, each 0.5～2.5 hour, merge extractive liquid,, decompression recycling ethanol also can be further through n-butanol extraction or mistake macropore resin purification, the dry Radix Ginseng extract that gets; Get Radix Paeoniae Rubra, decoct with water merge extractive liquid, 1～5 time, concentrate, add ethanol and make and contain the alcohol amount and be 40%-90%, mixing, leave standstill, reclaim ethanol, concentrate, or adopt macroporous resin to carry out purification, concentrate, the dry Radix Paeoniae Rubra extract that gets with Radix Ginseng extract and Radix Paeoniae Rubra extract mix homogeneously, adds adjuvant and is prepared into different preparations with diverse ways.

Described injection prepares like this: get the ginseng crude drug, adding 5～15 times of volume 50～80% ethanol cocurrent flows extracts 1～4 time, each 0.5～2.5 hour, merge extractive liquid,, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the water dissolution that adds 1～5 times of medical material volume, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.3～0.8ml/g medical material .min, use 1～10 times of resinite hydrops and 1～6 times of resin volume 5～15% alcohol flushing impurity successively, use 30～70% alcohol desorptions of 1～7 times of resin volume then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Radix Ginseng extract; Getting Radix Paeoniae Rubra adds 6～15 times of decoctings and boils 1～5 time, each 0.5～2.5 hour, merge extractive liquid,, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.3～0.8ml/g medical material .min, use 1～10 times of resinite hydrops and 1～6 times of resin volume 5～15% alcohol flushing impurity successively, use 40～80% alcohol desorptions of 1～7 times of resin volume then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the dry Radix Paeoniae Rubra extract that gets with Radix Paeoniae Rubra extract and Radix Ginseng extract mix homogeneously, adds adjuvant and is prepared into various injections with diverse ways.

The preparation method of the compound Chinese medicinal preparation of described treatment cardiovascular and cerebrovascular disease, it is characterized in that: the Injectable sterile block is preparation like this: get the ginseng crude drug, add 8 times of volume 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the water dissolution that adds 4 times of medical material volumes, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.5ml/g medical material .min, use 7 times of resinite hydrops and 5 times of resin volume 10% alcohol flushing impurity successively, use 60% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Radix Ginseng extract; Getting Radix Paeoniae Rubra adds 10 times of decoctings and boils 3 times, each 1.5 hours, merge extractive liquid,, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.3ml/g medical material .min, uses 5 times of resinite hydrops and 4 times of resin volume 10% alcohol flushing impurity successively, use 50% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Radix Paeoniae Rubra extract; With Radix Ginseng extract and Radix Paeoniae Rubra extract mix homogeneously, add the injection blunge make it the dissolving, boil the needle-use activated carbon that the back adds 0.2% (W/V), keep little and boiled 20 minutes, cold slightly filtration, filtrate adds the injection water to ormal weight, adjust pH 6.0～7.5, boil, coarse filtration, fine straining are spent the night in cold preservation (4 ℃); Injection mannitol is added the injection water be mixed with 120mg/ml solution, with above-mentioned filtrate mixing, coarse filtration, fine straining, packing, temperature-45 ℃, pre-freeze time 10h, the beginning evacuation, and in 12～72 hours differential gradient increased temperature to 10 ℃ progressively, keep 2h, be warming up to 20 ℃, keep 2h, promptly.

The adjuvant that is adopted in the described preparation comprises mannitol, galactose, glycine, glucose, sodium chloride, dextran, crospolyvinylpyrrolidone, glycerol, ethanol, propylene glycol, Polyethylene Glycol, sorbitol, tween, poloxamer, dextrin, starch, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, polyoxyethylene monostearate, polyethers, the Radix Glycyrrhizae charcoal, stevioside, vegetable oil, soybean oil, sorbitol, Pulvis Talci, Cera Flava, modified starch, magnesium stearate, dimethicone, in the liquid paraffin one or more.

Radix Ginseng extract that the present invention relates to and Radix Paeoniae Rubra extract can also be commercially available or adopt other preparation methoies to prepare.Radix Ginseng and extract thereof can also be Stem and leaf of Radix Ginseng part or Radix Ginseng Rubra or the Radix Codonopsis and the extracts thereof of same ratio, and Radix Paeoniae Rubra and extract thereof can also be the Radix Paeoniae Alba and the extracts thereof of same ratio.

Described preparation is mainly used in diseases such as treatment coronary heart disease, angina pectoris, myocardial ischemia.

Compared with prior art, the present invention is used as medicine with the crude drug Radix Ginseng, after suitably extracting, except the main effective ingredient of ginsenoside, chemical constituents such as somebody's gracilis polysaccharide, vitamin, trace element, the ginseng polysaccharide has antitumor, immunomodulating, effects such as blood sugar lowering; The multivitamin constituents that Radix Ginseng contains such as vitamin B1, B2, B12, C and nicotinic acid, pantothenic acid, folic acid, biotin etc. have certain effect to guaranteeing human body to the absorption of various vitamin, contain in the Radix Ginseng as zinc, ferrum, copper, potassium, calcium, strontium, germanium, arsenic etc. in 20 interior various trace elements, can balance body demand, the very high Ge element of content can promote cell new life in the Radix Ginseng simultaneously, increase frequency dividing cell, slow down aging; Thereby integrally-regulated function of human body, and then improve patients ' life quality, meet the theoretical and modern pharmacoeconomics theory of organic conception of traditional traditional Chinese medical science.And application for a patent for invention numbers 93103012.9 in the prior art, name is called " a kind of Chinese patent medicine for the treatment of angina pectoris " and number of patent application 01131789.2, name is called " a kind of Chinese medicine and law enforcement thereof that is used for the treatment of coronary heart disease " and all is used as medicine with the ginsenoside, though relief of symptoms is had certain curative effect, but benefiting action is not obvious, and is not proper to improving human body integral function function.The present invention simultaneously is equipped with has blood circulation promoting and blood stasis dispelling, the Radix Paeoniae Rubra of eliminating stasis to stop pain, and the physiologically active of gen-seng is stronger separately, bring into play the synergism of the two, to patient's symptom to improve effect more obvious, improved body function simultaneously, further strengthened the ability of resisting the exopathogen invasion.

The applicant has carried out following experiment, proves the effectiveness of medicine of the present invention.

Experimental example 1: medicament composing prescription experimental study

The research of table 1 prescription pharmacodynamics test

Pilot project	The Radix Ginseng group	The Radix Paeoniae Rubra group	Of the present invention group
				Myocardial ischemia test due to the dog coronary artery ligation method	Effect is general	Effect is obvious	Effect strengthens
To cardiac function and hemodynamic effects test	Partial action is obvious, and partial action is not obvious	Effect is general	Effect strengthens
				Anti-fatigue test	Effect is obvious	Effect is general	Effect strengthens
The blood circulation promoting and blood stasis dispelling test	Effect is general	Effect is obvious	Effect strengthens

Table 2 invention group and commercially available ginseng Chinese herbaceous peony group are relatively

Pilot project	Commercially available ginseng Chinese herbaceous peony group	Of the present invention group
			Myocardial ischemia test due to the dog coronary artery ligation method	Effect is obvious	Effect is obvious
To cardiac function and hemodynamic effects test	Effect is obvious	Effect is obvious
			The blood circulation promoting and blood stasis dispelling test	Effect is obvious	Effect is obvious
The mice hypoxia endurance test	Effect is general	Effect is obvious
			Mouse lymphocyte increment immunity test	Effect is general	Effect is obvious
The influence of atherosclerotic smooth muscle cell model cell endoperoxides lipid and cell regeneration amount	DeGrain	Effect is obvious

Experimental example 2: technical study

(1) Radix Paeoniae Rubra extracts solvent research

Get the Radix Paeoniae Rubra fine powder, use 90% ethanol, 70% ethanol, 50% alcohol reflux respectively, water boiling and extraction is an evaluation index with the paeoniflorin content.The results are shown in Table 3.

Table 3 different solvents extraction process relatively

Paeoniflorin content (%) meansigma methods

Extract solvent

1 2 3 4 (％)

90% ethanol 6.22 6.36 6.18 6.30 6.27

70% ethanol 7.25 7.32 7.36 7.48 7.35

50% ethanol 7.02 7.14 7.11 7.08 7.09

Water 7.37 7.28 7.31 7.33 7.32

As shown in Table 3, extract aqueous solvent and ethanol and all the most of glycoside composition in the Radix Paeoniae Rubra can be extracted, when still using 70% ethanol extraction by contrast, the glycoside component content is the highest, waterside it, but through the variance analysis there was no significant difference, consider to produce the actual water as solvent of selecting for use.

The different extraction times of table 4 are to the influence of peoniflorin extraction ratio

Sequence number	Decoct 1 extraction ratio (%)	Decoct 2 extraction ratios (%)	Decoct 3 extraction ratios (%)	Decoct 4 extraction ratios (%)
					1	50.25	72.30	81.68	85.22
2	52.35	71.85	82.32	85.69
					3	51.78	72.68	83.25	85.48
Meansigma methods (%)	52.04	72.54	83.32	85.99

As shown in Table 4, extraction time has certain influence to content of paeoniflorin in the Radix Paeoniae Rubra, and extract 1～4 time and all can extract effective ingredient to some extent, but peoniflorin extraction ratio substantially constant after extracting 3 times, consider production cost, so preferred extraction is best number of times 3 times.

Table 5 different extraction times are to the influence of peoniflorin extraction ratio

Extraction time (h)	0.5	1	1.5	2	2.5
						Peoniflorin extraction ratio (%)	70.25	79.85	85.36	86.25	87.14

As shown in Table 5, there is certain influence extraction time to content of paeoniflorin in the Radix Paeoniae Rubra, but all is in satisfied ratio at 0.5～2.5h peoniflorin extraction ratio, experiment is found, extract 1.5h～2.5h paeoniflorin content substantially constant, consider man-hour and extraction ratio, preferred 1.5h is optimum extraction time.

Table 6 amount of water is investigated table as a result

Tested number	Amount of water (doubly)			The peoniflorin extraction ratio
					For the first time	For the second time	For the third time	(％)
	1	8	8	8					83.08
2					10	10	10	86.59
	3	13	13	13					87.92
4					13	10	10	86.76
	5	13	10	8					85.57
6					10	10	8	84.51
	7	10	8	8					83.01

By table 6 as seen: the peoniflorin extraction ratio was the highest when amount of water was 13,13,13 times, and the peoniflorin extraction ratio is approaching when being 10,10,10 times with amount of water; The peoniflorin extraction ratio was minimum when amount of water was 8,8,8 times of amounts; Take all factors into consideration solvent load, extraction ratio and energy resource consumption, guaranteeing under the sufficient prerequisite of extracts active ingredients,, determine that extracting optimum amount of water is each 10 times of amounts in order to save cost.

(2) process for refining research

The comparison of process for purification:

The butanol extraction liquid method: precision is measured Radix Paeoniae Rubra extract, extracts 3 times with water saturated n-butyl alcohol jolting, merges n-butyl alcohol liquid, and evaporate to dryness, residue add methanol makes dissolving; Amberlyst process: precision is measured the Radix Paeoniae Rubra extracting solution, is added on the ZTC-1 type resin column of having handled well, after the water flushing, reuse 60% ethanol elution, collect eluent to effluent colourless till, measure content of paeoniflorin in two kinds of extract obtained cream powder of process for purification, the results are shown in Table 7.

The screening of table 7 process for purification

Process for purification paeoniflorin content %

N-butanol extraction 48.68

Macroporous adsorbent resin method 62.25

As can be seen from Table 7, select macroporous resin extraction rate height.

The research that the different model macroporous adsorbent resin influences than adsorbance total flavones:

Weight than adsorbance (absorption total flavones amount and dried resin weight ratio)=(in the amount of total flavones in the upper prop liquid-mistake post effluent in the amount-water elution liquid of total flavones the amount of total flavones)/dried resin.

The screening of table 8 resin model

The resin model is than adsorbance (%)

D-101 52.1

ZTC-1 68.5

AB-8 40.8

Table 8 shows: different resins can be made with extra care the purification Radix Paeoniae Rubra extract, and comparatively speaking, ZTC-1 type resin is bigger to the adsorbance of peoniflorin, so we determine with ZTC-1 type resin to be optimal case.

Experimental example 3: injection technical study

(1) pH value of solution is investigated

For adapting to the Human Physiology needs, consider the character of each constituents in the medicinal liquid simultaneously, the applicant has investigated the pH value of medicinal liquid.Select solution appearance, paeoniflorin content and clarity as evaluation index.

Test method and result: after feeding intake and handle by recipe quantity,, filter with the concentrated solution mix homogeneously by above-mentioned condition, add water to 1000ml, adjust pH is when the different pH value that reaches shown in the following table, boil the back standing over night, observe the variation of appearance character under different pH condition.Experimental result sees Table 9.

The investigation of table 9 dosing pH value (is evaluation index with the solution appearance)

Sequence number	1 2	3 4 5	6 7
				Dosing pH	5.5 6.0	6.5 7.0 7.5	8.0 8.5
Boil pH	5.0 5.6	6.2 6.8 7.3	7.8 8.2
				Outward appearance	Precipitation appears	No significant change	Color burn

Table 9 is the result show, medicinal liquid boils the back pH value and occur to precipitate at the sample 6.0 below, and pH value is obviously deepened in the color sample more than 7.5, and pH value is that 6.0～7.5 medicinal liquid is relatively stable, and outward appearance does not have significant change.Estimate from content below.The results are shown in Table 10.

The investigation of table 10 dosing pH value (is evaluation index with content)

Sequence number	Dosing pH	Paeoniflorin content (%)	Boil back pH	Paeoniflorin content (%)
					1	6.0	6.65	5.6	6.51
2	6.5	6.71	6.2	6.62
					3	7.0	6.88	6.8	6.80
4	7.5	7.02	7.3	6.95

As shown in Table 10, medicinal liquid is being adjusted the pH value front and back, the not too big variation of index components content of ginsenoside and paeoniflorin content.Verify from the clarity aspect that below the applicant has investigated 30 ℃ of stability of placing 3 months of injection of different pH value, the results are shown in Table 11.

The investigation of table 11 dosing pH value (is to investigate index with the clarity)

0 month March

pH

Clarity lamp inspection qualification rate % clarity lamp inspection qualification rate %

6.0 clear and bright 72.58 clear and bright 66.32

6.5 clear and bright 83.21 clear and bright 77.85

7.0 clear and bright 90.21 clear and bright 88.76

7.5 clear and bright 97.35 clear and bright 94.58

As shown in Table 11, medicinal liquid is between pH6.0～7.5, and clarity is better, and the appearance character of comprehensive above-mentioned medicinal liquid and ginsenoside and content of paeoniflorin change, and the pH value of medicinal liquid is transferred between 6.0～7.5 when determining dosing.

(2) screening of freeze-dried powder caffolding agent kind

The caffolding agent kind influences the molding of freeze-dried powder, so at first this is screened.The results are shown in Table 12.

The screening of table 12 caffolding agent kind

The caffolding agent kind	Caffolding agent: medicinal liquid (V: V)	Solubility	The finished product outward appearance
				Glucose	2∶1	Generally	Molding, the part atrophy
Galactose	2∶1	Good	Molding, part is frangible
				Mannitol	2∶1	Good	Molding
Glycine	2∶1	Generally	Molding, part is subsided
				Dextran	2∶1	Generally	Molding
Poloxamer, mannitol	2∶1	Good	Molding
				Mannitol, propylene glycol	2∶l	Good	Molding
Glycine, Polyethylene Glycol	2∶1	Good	Molding, a small amount of broken
				Blank medicinal liquid	3ml		Atrophy

As shown in Table 12, in the adjuvant that is screened, investigate from the solubility angle of yield rate, molding situation and sample, use the effect of mannitol to be better than other several adjuvants, but other adjuvant also can molding, just yield rate is poor slightly than mannitol, consider simultaneously to reduce to add too much adjuvant, so optimal case is selected to use mannitol as caffolding agent separately as far as possible.

Experimental example 4: dispersible tablet disintegrating agent screening

The kind of disintegrating agent, quantity directly have influence on the dispersing uniformity of preparation in the dispersible tablet, are the leading indicators of weighing the dispersible tablet quality, thus we to select disintegration time for use be that performance assessment criteria is investigated different disintegrating agents, the results are shown in Table 13.

Table 13 disintegrating agent table of merit rating

Disintegrating agent	With the ointment ratio	Disintegration time (minute)
			Crospolyvinylpyrrolidone	1∶1	2.6
Low-substituted hydroxypropyl cellulose	1∶1	2.8
			Carboxymethyl starch sodium	1∶1	2.7
Crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose	1∶1	2.3
			Low-substituted hydroxypropyl cellulose, microcrystalline Cellulose	1∶1	2.5

From the result of above-mentioned test as can be seen, most of disintegrating agent can improve the disintegration time of dispersible tablet, all can reach the requirement of dispersible tablet.But by contrast, after employing crospolyvinylpyrrolidone and the low-substituted hydroxypropyl cellulose combination, the disintegrate best results.

Experimental example 5: drop pill substrate screening

The inventor is by a large amount of tests, extract is prepared into the required substrate of drop pill to be investigated, different etc. with fusion situation, the ball method of double differences of drop pill outward appearance, principal agent and substrate serves as to investigate index, optimizes and has screened the substrate that influences the drop pill quality, result of the test such as table 14.

Method: substrate is put in the small beaker, be heated to 80-90 ℃, after treating whole fusions, the mixed material that adds Radix Ginseng extract and Radix Paeoniae Rubra extract, investigate the fusion situation of substrate and material, (drip the system condition: expect 75 ℃ of temperature, coolant is a dimethicone to the system of dripping to select the fusion situation to write out a prescription preferably, drip apart from 3～7cm, drip 30～40 droplets/minute of speed).

Table 14 substrate screening test

Sequence number	1	2	3	4	5
						Material heavy (g)	10	10	10	10	10
PEG4000	15	15	-	-	-
						PEG6000	-	-	-	15	15
Polyoxyethylene monostearate	-	5	5	-	-
						Polyethers	-	-	-	5	-
Poloxamer	-	-	15	-	5
						Substrate and material merge situation	Poor slightly	Better	Relatively poor	Better	Better
The drop pill outward appearance	Smooth, roundness is poor slightly	Smooth, roundness is good	Roundness is poor	Smooth, roundness is good	Smooth, roundness is good
						The ball method of double differences is different	7.1％	6.5％	10％	8.3％	7.5％

From above table as can be seen, most of substrate can satisfy the needs of preparations shaping, but takes all factors into consideration the combination condition optimum with PEG4000 and polyoxyethylene monostearate.

Concrete embodiment

(part is a unit of weight, as ton, kilogram, gram)

Embodiment 1: 99 parts of 1 part of Radix Paeoniae Rubra of Radix Ginseng

Get the ginseng crude drug, add 8 times of volume 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the water dissolution that adds 4 times of medical material volumes, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.5ml/g medical material .min, use 7 times of resinite hydrops and 5 times of resin volume 10% alcohol flushing impurity successively, use 60% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Radix Ginseng extract; Getting Radix Paeoniae Rubra adds 10 times of decoctings and boils 3 times, each 1.5 hours, merge extractive liquid,, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.3ml/g medical material .min, uses 5 times of resinite hydrops and 4 times of resin volume 10% alcohol flushing impurity successively, use 50% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Radix Paeoniae Rubra extract; With Radix Ginseng extract and Radix Paeoniae Rubra extract mix homogeneously, add the injection blunge make it the dissolving, boil the needle-use activated carbon that the back adds 0.2% (W/V), keep little and boiled 20 minutes, cold slightly filtration, filtrate adds the injection water to ormal weight, adjust pH 6.0～7.5, boil, coarse filtration, fine straining are spent the night in cold preservation (4 ℃); Injection mannitol is added the injection water be mixed with 120mg/ml solution, with above-mentioned filtrate mixing, coarse filtration, fine straining, packing, temperature-45 ℃, pre-freeze time 10h, the beginning evacuation, and in 12～72 hours differential gradient increased temperature to 10 ℃ progressively, keep 2h, be warming up to 20 ℃, keep 2h, promptly get the aseptic block of lyophilizing.After testing, ginsenoside's constituents content is 1.1%; Derive from Radix Ginseng saponin component, all can be surveyed the component content sum and account for 27% of the total solid after the deduction adjuvant amount and water quantities in the preparation to derive from the glycoside composition of Radix Paeoniae Rubra and other.

Embodiment 2: 1 part of 99 parts of Radix Paeoniae Rubra of Radix Ginseng Rubra

Get the Radix Ginseng Rubra medical material, add 10 times of volume 70% alcohol reflux 2 times, each 1 hour, merge extractive liquid,, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the water dissolution that adds 3 times of medical material volumes, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.4ml/g medical material .min, use 6 times of resinite hydrops and 3 times of resin volume 5% alcohol flushing impurity successively, use 60% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Radix Ginseng Rubra extract; Getting Radix Paeoniae Rubra adds 8 times of decoctings and boils 3 times, each 2 hours, merge extractive liquid,, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.5ml/g medical material .min, uses 5 times of resinite hydrops and 4 times of resin volume 10% alcohol flushing impurity successively, use 50% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Radix Paeoniae Rubra extract; With Radix Paeoniae Rubra extract and Radix Ginseng extract mix homogeneously, add the injection blunge make it the dissolving, medicinal liquid is standby; With above-mentioned two medicinal liquid mix homogeneously, regulating pH value is 6.0～7.5, adds 0.2% activated needle-use activated carbon, boil absorption, carbon removal, fine straining, filtrate adds the injection water to ormal weight, spend the night 4 ℃ of cold preservations, coarse filtration, fine straining divide to install in the ampoule bottle sterilization, packing promptly gets the injection with small volume or the concentrated solution for injection that are directly used in drug administration by injection.After testing, content of paeoniflorin accounts in the preparation 0.13% of total solid after deduction adjuvant amount and the water quantities

Embodiment 3: 99 parts of 99 portions of Radix Paeoniae Albas of Radix Ginseng

Get the ginseng crude drug, add 5 times of volume 50% alcohol reflux 2 times, each 1.5 hours, merge extractive liquid,, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the water dissolution that adds 2 times of medical material bulking values, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.3ml/g medical material .min, use 8 times of resinite hydrops and 5 times of resin volume 5% alcohol flushing impurity successively, use 40% alcohol desorption of 6 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Radix Ginseng extract; Get the Radix Paeoniae Alba and add 13 times of decoctings and boil 3 times, each 1.0 hours, merge extractive liquid,, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.4ml/g medical material .min, uses 5 times of resinite hydrops and 6 times of resin volume 5% alcohol flushing impurity successively, use 60% alcohol desorption of 6 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Radix Paeoniae Alba extract, two extracts are merged, add the dissolving of injection water, adjust pH filters between 5.0～7.0, filtrate adds the glucose of ormal weight, boil, regulating pH value is 6.0～7.5, adds 0.3% activated needle-use activated carbon, boil absorption, carbon removal, fine straining is spent the night in 4 ℃ of placements, filtrate adds the injection water to ormal weight, packing, sterilization promptly gets the glucose intravenous infusion agent.

Embodiment 4: 1 part of 1 part of Radix Paeoniae Rubra of Stem and leaf of Radix Ginseng

Take by weighing the Radix Ginseng cured leaf, add 10 times of volume 60% alcohol reflux 3 times, each 1.5 hours, merge extractive liquid,, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the water dissolution that adds 4 times of medical material bulking values, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.5ml/g medical material .min, use 7 times of resinite hydrops and 5 times of resin volume 10% alcohol flushing impurity successively, use 60% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Radix Ginseng extract; Getting Radix Paeoniae Rubra adds 12 times of decoctings and boils 2 times, each 0.5 hour, merge extractive liquid,, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.8ml/g medical material .min, use 7 times of resinite hydrops and 3 times of resin volume 15% alcohol flushing impurity successively, use 60% alcohol desorption of 2 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the dry Radix Paeoniae Rubra extract that gets, with extract of Radix Ginseng stem and leaf and Radix Paeoniae Rubra extract mix homogeneously, add and inject the dissolving of blunging, filter, filtrate is boiled the needle-use activated carbon of back by quality percent by volume adding 0.2%, keep little and boiled 30 minutes, cold slightly filtration, filtrate adjust pH 6.0～7.5, boil, coarse filtration is spent the night in 4 ℃ of cold preservations, fine straining adds an amount of 0.9% sodium chloride solution through boiling, be diluted to ormal weight with water for injection, promptly get the sodium chloride infusion solution

Embodiment 5: 1 part of 20 parts of Radix Paeoniae Alba extract of Radix Ginseng Rubra

Get the Radix Ginseng Rubra medical material, add 8 times of volume 70% alcohol reflux 3 times, each 1 hour, measuring relative density when merge extractive liquid,, decompression recycling ethanol to 60 ℃ was 1.05～1.15, the water dissolution that adds 4 times of medical material volumes, filter, filtrate is crossed D101 type macroporous adsorbent resin with the speed of 0.5ml/g medical material .min, uses 7 times of resinite hydrops and 5 times of resin volume 10% alcohol flushing impurity successively, use 60% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Radix Ginseng Rubra extract, mix with Radix Paeoniae Alba extract, add an amount of water for injection dissolving, by volume add 1.2% needle-use activated carbon, boil, keep little 20min that boils, cold slightly filtration, filtrate add the injection water to ormal weight, adjust pH 6.0～7.5, boil, spend the night coarse filtration 4 ℃ of cold preservations, fine straining divides to install in the enamel tray, temperature-40 ℃, pre-freeze time 10h;-35 ℃ of evacuation keep 8h; Be warming up to-30 ℃ again, keep 8h; Be warming up to-20 ℃, keep 8h; Be warming up to-10 ℃, keep 4h; Be warming up to 0 ℃, keep 4h; Be warming up to 10 ℃, keep 2h; Be warming up to 20 ℃, keep 2h, under aseptic condition, divide to install in the cillin bottle, promptly get the freeze dry sterile powder end.After testing, the content of ginsenoside's constituents accounts for 3.1% of total solid after deduction adjuvant amount and the water quantities in the preparation; In the preparation glycoside composition of the saponin component of Radix Ginseng, Radix Paeoniae Rubra and other all can survey the component content sum and account for 38% of the total solid after the deduction adjuvant amount and water quantities in the preparation.

Embodiment 6: 90 parts of 10 parts of Radix Paeoniae Rubra of Radix Codonopsis

Get codonopsis pilosula, add 10 times of volume 60% alcohol reflux 3 times, each 1.5 hours, merge extractive liquid,, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the water dissolution that adds 3 times of medical material volumes, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.5ml/g medical material .min, use 4 times of resinite hydrops and 2 times of resin volume 7% alcohol flushing impurity successively, use 60% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Radix Codonopsis extract; Getting Radix Paeoniae Rubra adds 10 times of decoctings and boils 2 times, each 2.5 hours, merge extractive liquid, filtered, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.6ml/g medical material .min, use 2 times of resinite hydrops and 4 times of resin volume 15% alcohol flushing impurity successively, use 70% alcohol desorption of 4 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the dry Radix Paeoniae Rubra extract that gets with Radix Paeoniae Rubra extract and Radix Codonopsis extract's mix homogeneously, adds an amount of water for injection stirring and dissolving, the needle-use activated carbon that adds 0.2% (W/V), boil, keep little 40min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, adjust pH 6.0～7.5 boils, and spends the night 5 ℃ of cold preservations, coarse filtration, fine straining, in inlet temperature is 150 ℃, and leaving air temp is 70 ℃, and air velocity is 18ms ^-1Condition under spray drying get powder, packing promptly gets the spray drying sterilized powder.

Embodiment 7: 50 parts of 50 parts of Radix Paeoniae Rubra extracts of Radix Codonopsis

Get codonopsis pilosula, add 6 times of volume 75% alcohol reflux 3 times, each 1.5 hours, measuring relative density when merge extractive liquid,, decompression recycling ethanol to 60 ℃ is 1.05～1.15, merges with Radix Paeoniae Rubra extract, it is an amount of to add PEG4000 and polyoxyethylene monostearate (3: 1),, mix homogeneously, heating and melting stirs, and is transferred to the drop pill machine, with dimethicone or liquid paraffin is coolant, drips system, collects drop pill, remove the dimethicone or the liquid paraffin on surface, promptly get drop pill.

Embodiment 8: 20 parts of 80 portions of Radix Paeoniae Albas of Radix Ginseng

Get the ginseng crude drug, add 8 times of amount 80% alcohol reflux 3 times after the pulverizing, each 1 hour, merge extractive liquid, filters, and filtrate recycling ethanol is 1.05～1.10 during to 60 ℃ of relative densities, drying under reduced pressure is made Radix Ginseng extract, get Radix Paeoniae Rubra, add 13,10,10 times of decoctings boil 3 times, each 1.5 hours, merge extractive liquid,, measuring relative density when being concentrated into 50 ℃ is 1.35～1.40, with Radix Ginseng extract and Radix Paeoniae Alba extract mixing, makes soft material, dry, be ground into fine powder, add stevioside and starch is an amount of, mixing, use 65% alcohol granulation, drying, encapsulated, promptly get capsule.Content of paeoniflorin accounts in the preparation 0.21% of total solid after deduction adjuvant amount and the water quantities

Embodiment 9: 10 parts of 5 parts of Radix Paeoniae Alba extracts of extract of Radix Ginseng stem and leaf

With extract of Radix Ginseng stem and leaf and Radix Paeoniae Alba extract mixing, add the vegetable oil of 1 times of medicated powder weight and 3% Cera Flava, the dropping preparation method pill, compacting promptly gets soft capsule.

Embodiment 10: 20 parts of 10 parts of Radix Paeoniae Rubra extracts of Radix Ginseng Rubra

Get the Radix Ginseng Rubra medical material, be ground into coarse powder,, make solvent with 70% ethanol according to the percolation under fluid extract and the extractum item, flood after 24 hours, percolation is not till have a saponin reaction, and percolate reclaims ethanol, and is condensed into fluid extract, the water that adds 4 times of amounts, with adding with stirring, left standstill 48 hours, it is standby to get supernatant; Precipitate merges through post precipitation and supernatant with 75% washing with alcohol three times, washing liquid, reclaims ethanol, and is condensed into fluid extract, with the Radix Paeoniae Alba extract mix homogeneously, is ground into fine powder, and it is an amount of to add MCC and hydroxypropyl starch, and tabletting promptly gets oral cavity disintegration tablet.

Embodiment 11: 99 parts of 1 portion of Radix Paeoniae Albas of Radix Codonopsis

Get the ginseng crude drug, add 6 times of volume 75% alcohol reflux 2 times, each 1.5 hours, merge extractive liquid,, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, adds the water dissolution of 4 times of medical material volumes, places, filter, the filtrate concentrate drying gets Radix Ginseng extract; Getting the Radix Paeoniae Alba adds 10 times of decoctings and boils 3 times, each 1.5 hours, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.35～1.40, add the ethanol precipitate with ethanol twice, make for the first time that to contain the alcohol amount be 60%, make that to contain the alcohol amount be 80% for the second time, reclaiming and measuring relative density when ethanol is concentrated into 60 ℃ is 1.35～1.40, make soft material, drying is ground into fine powder, sieves, add above-mentioned Radix Ginseng extract mix homogeneously, it is an amount of to add stevioside and starch, and mixing is granulated, dry, tabletting, coating promptly gets tablet.

Embodiment 12: 50 parts of 0.1 part of Radix Paeoniae Rubra of Radix Ginseng Rubra extract

Getting Radix Paeoniae Rubra adds 10 times of decoctings and boils 3 times, each 1.5 hours, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, add ethanol precipitate with ethanol twice, make that to contain the alcohol amount be 60% for the first time, make that to contain the alcohol amount be 80% for the second time, reclaiming and measuring relative density when ethanol is concentrated into 60 ℃ is 1.05～1.15, exsiccant Radix Paeoniae Rubra extract; With Radix Paeoniae Rubra extract and Radix Ginseng Rubra extract mix homogeneously, add 1: 1 disintegrating agent of an amount of crospolyvinylpyrrolidone and low-substituted hydroxypropyl cellulose, it is moistening to add 75% ethanol, system material, granulate, tabletting promptly gets dispersible tablet.

Embodiment 13: 70 parts of 30 parts of Radix Paeoniae Rubra of Folium Ginseng

Get the Folium Ginseng medical material, add 10 times of volume 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, adds 2 times of amount n-butyl alcohol, shaking out 5 times, merge n-butyl alcohol liquid, measuring relative density during decompression and solvent recovery to 60 ℃ is 1.05～1.15, dry extract of Radix Ginseng leaf; Getting Radix Paeoniae Rubra adds 10 times of decoctings and boils 3 times, each 1.5 hours, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, add ethanol precipitate with ethanol twice, make that to contain the alcohol amount be 60% for the first time, make that to contain the alcohol amount be 80% for the second time, reclaiming and measuring relative density when ethanol is concentrated into 60 ℃ is 1.05～1.15, exsiccant Radix Paeoniae Rubra extract; With above-mentioned two extract mixings, add 720% ethanol, the spheronization pill promptly gets pellet.

Embodiment 14: 15 parts of 99 parts of Radix Paeoniae Alba extracts of Radix Ginseng

Get the ginseng crude drug, add 8 times of amount 70% alcohol reflux 3 times after the pulverizing, each 1 hour, merge extractive liquid, filters, and filtrate recycling ethanol is 1.05～1.10 during to 60 ℃ of relative densities, drying under reduced pressure is made Radix Ginseng extract, with Radix Ginseng extract and Radix Paeoniae Alba extract mixing, and the system soft material, drying is ground into fine powder, adds stevioside and starch is an amount of, mixing, granulate, drying promptly gets granule.

Claims (14)

1, a kind of compound Chinese medicinal preparation for the treatment of cardiovascular and cerebrovascular disease, it is characterized in that: calculate according to composition by weight, it is made by 1～99 part of Radix Ginseng and 99～1 parts of Radix Paeoniae Rubra or by the Radix Ginseng extract and the Radix Paeoniae Rubra extract that obtains behind extraction separation of corresponding weight portion Radix Paeoniae Rubra of corresponding weight portion Radix Ginseng through obtaining behind the extraction separation

2, according to the compound Chinese medicinal preparation of the described treatment cardiovascular and cerebrovascular disease of claim 1, it is characterized in that calculating according to components by weight percent, it is made by 10～80 parts of Radix Ginsengs and 90～20 parts of Radix Paeoniae Rubra or by the Radix Ginseng extract and the Radix Paeoniae Rubra extract that obtains behind extraction separation of corresponding weight portion Radix Paeoniae Rubra of corresponding weight portion Radix Ginseng through obtaining behind the extraction separation.

3, according to the compound Chinese medicinal preparation of claim 1 or 2 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: calculate according to components by weight percent, it is made by 30～60 parts of Radix Ginsengs and 70～40 parts of Radix Paeoniae Rubra or by the Radix Ginseng extract and the Radix Paeoniae Rubra extract that obtains behind extraction separation of corresponding weight portion Radix Paeoniae Rubra of corresponding weight portion Radix Ginseng through obtaining behind the extraction separation.

4, according to the compound Chinese medicinal preparation of any described treatment cardiovascular and cerebrovascular disease of claim 1～3, it is characterized in that: preparation of the present invention is injection and oral formulations; Injection comprises: be directly used in drug administration by injection injection, need to be used for the concentrated solution for injection of intravenous drip after the dilution, directly for the venous transfusion of intravenous drip and injectable sterile powder and the aseptic block that makes with freeze-drying or spray drying method; Oral formulations comprises: all acceptable dosage forms on tablet, dispersible tablet, effervescent tablet, oral cavity disintegration tablet, capsule, soft capsule, microcapsule, granule, pill, powder, drop pill, slow releasing preparation, controlled release preparation, oral liquid, soft extract, extractum, gel, membrane and other pharmaceuticss.

5, according to the compound Chinese medicinal preparation of the described treatment cardiovascular and cerebrovascular disease of claim 4, it is characterized in that: preparation of the present invention is the injection that is directly used in drug administration by injection, need to be used for the concentrated solution for injection of intravenous drip after the dilution, directly for the venous transfusion of intravenous drip and injectable sterile powder and aseptic block, drop pill, capsule, soft capsule, oral cavity disintegration tablet, tablet, pellet, dispersible tablet or the granule that makes with freeze-drying or spray drying method.

6, according to the compound Chinese medicinal preparation of claim 4 or 5 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: calculate according to percentage by weight, wherein the content of ginsenoside's constituents is not less than 1% of the total solid after the deduction adjuvant amount and water quantities in the preparation; Content of paeoniflorin is not less than in the preparation 0.1% of total solid after deduction adjuvant amount and the water quantities; Derive from the injection Radix Ginseng saponin component, all can be surveyed the component content sum and are not less than 25% of the total solid after the deduction adjuvant amount and water quantities in the preparation to derive from the glycoside composition of Radix Paeoniae Rubra and other.

7, preparation method according to the compound Chinese medicinal preparation of claim 4 or 5 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: get Radix Ginseng, the Radix Paeoniae Rubra medical material, add water or ethanol extraction respectively, extracting solution through suitably concentrate the medical material crude extract, further adopt water precipitating, precipitate with ethanol, organic solvent extractionprocess, flocculent precipitation, one or more of column chromatography are united use and are carried out suitably refining, get the extract of Radix Ginseng and Radix Paeoniae Rubra medical material respectively, with ginseng crude drug's the crude extract or the crude extract or the extract mixing of extract and Radix Paeoniae Rubra medical material, add adjuvant and be prepared into different preparations with diverse ways.

8, according to the preparation method of the compound Chinese medicinal preparation of the described treatment cardiovascular and cerebrovascular disease of claim 7, it is characterized in that: get the ginseng crude drug, add 5～15 times of volume 50～80% alcohol reflux 1～4 time, each 0.5～2.5 hour, merge extractive liquid,, decompression recycling ethanol, or through n-butanol extraction or mistake macropore resin purification, the dry Radix Ginseng extract that gets; Get Radix Paeoniae Rubra, decoct with water merge extractive liquid, 1～5 time, concentrate, add ethanol and make and contain the alcohol amount and be 40%-90%, mixing, leave standstill, reclaim ethanol, concentrate, or adopt macroporous resin to carry out purification, concentrate, the dry Radix Paeoniae Rubra extract that gets with Radix Ginseng extract and Radix Paeoniae Rubra extract mix homogeneously, adds adjuvant and is prepared into different preparations with diverse ways.

9, preparation method according to the compound Chinese medicinal preparation of claim 7 or 8 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: injection is preparation like this: get the ginseng crude drug, add 5～15 times of volume 50～80% alcohol reflux 1～4 time, each 0.5～2.5 hour, merge extractive liquid,, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the water dissolution that adds 1～5 times of medical material volume, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.3～0.8ml/g medical material .min, use 1～10 times of resinite hydrops and 1～6 times of resin volume 5～15% alcohol flushing impurity successively, use 30～70% alcohol desorptions of 1～7 times of resin volume then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Radix Ginseng extract; Getting Radix Paeoniae Rubra adds 6～13 times of decoctings and boils 1～5 time, each 0.5～2.5 hour, merge extractive liquid,, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.3～0.8ml/g medical material .min, use 1～10 times of resinite hydrops and 1～6 times of resin volume 5～15% alcohol flushing impurity successively, use 40～80% alcohol desorptions of 1～7 times of resin volume then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the dry Radix Paeoniae Rubra extract that gets with Radix Paeoniae Rubra extract and Radix Ginseng extract mix homogeneously, adds adjuvant and is prepared into various injections with diverse ways.

10, preparation method according to the compound Chinese medicinal preparation of any described treatment cardiovascular and cerebrovascular disease of claim 7～9, it is characterized in that: the Injectable sterile block is preparation like this: get the ginseng crude drug, add 8 times of volume 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the water dissolution that adds 4 times of medical material volumes, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.5ml/g medical material .min, use 7 times of resinite hydrops and 5 times of resin volume 10% alcohol flushing impurity successively, use 60% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Radix Ginseng extract; Getting Radix Paeoniae Rubra adds 10 times of decoctings and boils 3 times, each 1.5 hours, merge extractive liquid,, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.3ml/g medical material .min, uses 5 times of resinite hydrops and 4 times of resin volume 10% alcohol flushing impurity successively, use 50% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Radix Paeoniae Rubra extract; With Radix Ginseng extract and Radix Paeoniae Rubra extract mix homogeneously, add the injection blunge make it the dissolving, boil the needle-use activated carbon that the back adds 0.2% (W/V), keep little and boiled 20 minutes, cold slightly filtration, filtrate adds the injection water to ormal weight, adjust pH 6.0～7.5, boil, coarse filtration, fine straining are spent the night in cold preservation (4 ℃); Injection mannitol is added the injection water be mixed with 120mg/ml solution, with above-mentioned filtrate mixing, coarse filtration, fine straining, packing, temperature-45 ℃, pre-freeze time 10h, the beginning evacuation, and in 12～72 hours differential gradient increased temperature to 10 ℃ progressively, keep 2h, be warming up to 20 ℃, keep 2h, promptly.

11, according to the preparation method of the compound Chinese medicinal preparation of any described treatment cardiovascular and cerebrovascular disease in the claim 7～9, it is characterized in that: the adjuvant that is adopted in the preparation comprises mannitol, galactose, glycine, glucose, sodium chloride, dextran, crospolyvinylpyrrolidone, glycerol, ethanol, propylene glycol, Polyethylene Glycol, sorbitol, tween, poloxamer, dextrin, starch, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, polyoxyethylene monostearate, polyethers, the Radix Glycyrrhizae charcoal, stevioside, vegetable oil, soybean oil, sorbitol, Pulvis Talci, Cera Flava, modified starch, magnesium stearate, dimethicone, in the liquid paraffin one or more.

12, according to the compound Chinese medicinal preparation of any described treatment cardiovascular and cerebrovascular disease in the claim 1～3,7～10, it is characterized in that: Radix Ginseng extract and Radix Paeoniae Rubra extract can also be commercially available or adopt other preparation methoies to prepare.

13, according to the compound Chinese medicinal preparation of any described treatment cardiovascular and cerebrovascular disease in the claim 1～3,7～10, it is characterized in that: Radix Ginseng and extract thereof can also be Stem and leaf of Radix Ginseng part or Radix Ginseng Rubra or the Radix Codonopsis and the extracts thereof of same ratio, and Radix Paeoniae Rubra and extract thereof can also be the Radix Paeoniae Alba and the extracts thereof of same ratio.

14, according to the application of the described compound Chinese medicinal preparation of claim 1～3 in disease medicaments such as preparation treatment coronary heart disease, angina pectoris, myocardial ischemia.