CN100571767C - A kind of Chinese medicine composition that is used for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof - Google Patents
A kind of Chinese medicine composition that is used for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof Download PDFInfo
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Abstract
The invention provides a kind of cardiovascular and cerebrovascular vessel treatment and use Chinese medicine composition, it mainly is made up of Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Curcumae, Fructus Crataegi, Radix Polygoni Multiflori Preparata and Rhizoma Gastrodiae.Add suitable adjuvant simultaneously, be used for the treatment of dizziness and headache, palpitation and insomnia and sensation of oppression over the chest with shortness of breath due to the blood stasis liver-yang hyperactivity.The preparation method of said composition also is provided simultaneously: Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Curcumae, Fructus Crataegi, Radix Polygoni Multiflori Preparata are pulverized, are decocted with water, filtering and standing, supernatant concentration, again with Rhizoma Gastrodiae and other adjuvants with the concentrate mix homogeneously, granulate, drying, promptly.Said composition has steady quality, and advantage such as facilitate patients.
Description
Technical field
The present invention relates to a kind of prescription and preparation technology thereof of Chinese medicine preparation, particularly a kind of Chinese medicine composition that is used for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof.
Background technology
Dizziness and headache, palpitation and insomnia, sensation of oppression over the chest with shortness of breath are generally due to the cardiovascular and cerebrovascular disease for doctor trained in Western medicine due to the blood stasis liver-yang hyperactivity.And cardiovascular and cerebrovascular disease is a kind of incidence rate and all very high disease of mortality rate at present.The treatment cardiovascular and cerebrovascular vessel medication of selling on the market mostly is chemical pharmacy greatly, often brings more harm to patient body and take chemicals for a long time.Therefore, the medicine of inventing a kind of determined curative effect, safe ready, treatment cardiovascular and cerebrovascular disease that toxic and side effects is little seems extremely important.
China's tradition traditional Chinese medical science is used the pharmacy of natural animal-plant product and is particular about the monarch collocation of various main materials and auxiliary materials, and its toxic and side effects is low, is fit to take for a long time.At present disclose some and be used for the Chinese medicine composition of cardiovascular and cerebrovascular diseases, but most prescription complexity, usually relate to tens flavor Chinese crude drugs, as having adopted Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Radix Notoginseng, Rhizoma Corydalis, Fructus Crataegi, Radix Bupleuri, Radix Curcumae, Rhizoma Alismatis, Radix Puerariae, Folium Ginkgo, Radix Polygoni Multiflori, Rhizoma Polygonati, Ganoderma, Fructus Schisandrae Chinensis, Leptoradix Ginseng to be Main Ingredients and Appearance treatment coronary heart disease among the patent application CN02130822, so complicated prescription has increased the preparation difficulty, and be difficult to more ensure drug quality, reduced drug safety.
In addition, also have part Chinese medicine composition prescription too simple, in patent application CN200610083268, only adopted Radix Salviae Miltiorrhizae and Rhizoma Chuanxiong two flavor medical materials.Be difficult to bring into play the compatibility effect of different medical materials in the theory of Chinese medical science like this, thereby be difficult to realize better drug effect.
And in the existing Chinese medicine extraction method, used as organic solvents such as ethanol mostly.Like this active ingredient is caused certain destruction, and produced other materials that some are not expected, reduced the safety of medication.
The inventor gropes through long-term experiment, filters out 6 flavor Chinese medicines from 1,100 kinds of Chinese medicinal herbses, system be made into have promoting blood circulation to remove blood stasis, the compound Chinese medicinal preparation of suppressing the hyperactive liver to relieve the wind syndrome effect.This compound preparation reasonable recipe, a few flavor medical materials complement each other, and have strengthened the therapeutic effect for cardiovascular and cerebrovascular disease greatly.Except sophisticated process route, the present invention has also set up complete quality control system, and the composition quality of being produced is stable, safe, facilitate patients.
Summary of the invention
One of the object of the invention is to provide a kind of Chinese medicine composition of stay-in-grade treatment cardiovascular and cerebrovascular disease, and another purpose of the present invention provides a kind of preparation method of this Chinese medicine composition.
To achieve these goals, the present invention takes following technological means:
A kind of Chinese medicine composition for the treatment of cardiovascular and cerebrovascular disease, it is characterized in that, described compositions effective ingredient comprises following component: Rhizoma Chuanxiong 200-300 part, Radix Salviae Miltiorrhizae 100-200 part, Radix Curcumae 50-150 part, Fructus Crataegi 100-300 part, Radix Polygoni Multiflori Preparata 150-250 part, Rhizoma Gastrodiae 20-70 part, described part is weight portion.
In above-mentioned a few flavor Chinese medicines, Rhizoma Chuanxiong has promoting flow of QI and blood, the wind-expelling pain-stopping effect.Its main composition is tetramethylpyazine (TMP).TMP can pass through blood brain barrier, improves disturbance of cerebral circulation, and neuron and mitochondrion are had protective effect, and damage has protective effect to tissue ischemias such as the heart, kidney, livers.Vascular smooth muscle is also had spasmolysis, and the aortic article that has epinephrine or potassium chloride to cause is shunk obvious antagonism.Can be used for treatments such as coronary heart disease, thrombotic disease, ischemic encephalopathy clinically, have good effect.
Radix Salviae Miltiorrhizae has stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, the relieving restlessness effect clears away heart-fire.Its water-soluble components all has beneficial effect based on Radix Salviae Miltiorrhizae total phenolic acids to myocardial ischemia, heart and brain tissues energy metabolism.Can dwindle myocardial infarct size and alleviate the course of disease, also obvious coronary artery dilator influences platelet and discharges angiogenic substance and influence zymoplastin.
Radix Curcumae has the effect of blood-activating and qi-promoting pain relieving, heart fire-clearing upset-relieving, promoting the function of the gallbladder to alleviate jaundice, cooling blood for hemostasis.Aspect hepatic cholagogic, antitumor and the blood fat reducing outstanding role is being arranged, the utmost point is hopeful to develop and becomes the novel treatment that effectively prevents blood vessel scleratheroma and novel hepatic cholagogic medicine and cancer therapy drug.
Fructus Crataegi can prevent and treat cardiovascular disease, and Fructus Crataegi can increase myocardial contraction, increase cardiac output, decreasing heart rate, coronary artery dilator blood vessel, increase coronary flow, reduction myocardial oxygen consumption.Can also dwindle myocardial infarct size.Effective ingredient all has the speedup effect to platelet, erythrocyte electrophoresis, helps improving hemodynamics, improves erythrocyte and platelet surface electric charge, increases the repulsion between the cell, accelerates their flow velocitys in blood, promotes axial flow, reduces limit stream and gathering and sticks.Thrombosis due to the arteries endothelial injury had the obvious suppression effect.
Radix Polygoni Multiflori Preparata invigorating the liver and kidney, benefiting essence-blood, strengthening bone and muscle, but relieving leukorrhea by astringents also are used for diseases such as Liver and kidney two void, the empty few soreness of the waist and knees of essence and blood, dizziness and blurred vision, early whitening of beard and hair, seminal emission, metrorrhagia, leukorrhagia.It also has blood fat reducing and study of anti-atherogenic effect, and the water extract of Radix Polygoni Multiflori Preparata is the blood fat reducing level obviously, delays development of atherosclerosis.In addition, it has preventive effect to myocardial ischemia reperfusion injury.
Rhizoma Gastrodiae cures mainly diseases such as hypertension, dizzy, headache, facial hemiparalysis, numb limbs and tense tendons, infantile convulsion.At present Chinese and western medicine is clinically often treated convulsion with spasms, numb limbs and tense tendons with the other medicines compatibility, headache is dizzy, nerve is painful, angina pectoris, facial spasm etc.
To sum up, the effect of a few flavor Chinese medicine is complemented each other, all suitable treatment that is used as cardiovascular and cerebrovascular disease.
According to Chinese medicine composition noted earlier, described compositions effective ingredient comprises following component: 267 parts of Rhizoma Chuanxiongs, 167 parts of Radix Salviae Miltiorrhizaes, 100 parts of Radix Curcumaes, 200 parts of Fructus Crataegis, 213 parts of Radix Polygoni Multiflori Preparatas, 53 parts in Rhizoma Gastrodiae.
Chinese medicine composition of the present invention is not simply piling up of several same curative effect medicines, if above-mentioned a few flavor medical material is taken separately according to this composition dosage, often produces strong side effect.Can cause anaphylaxis edema, dizziness, weak, uncomfortable in chest, puffiness of face as Rhizoma Gastrodiae is for oral administration.And the Rhizoma Chuanxiong excess is taken and is caused poisoning, severe headache and vomiting.The inventor gropes through experiment repeatedly, when determining that several components reach as above ratio, side effect will be able to arrive bottom line even disappearance, and therapeutic effect enhancing significantly on the contrary.
According to foregoing Chinese medicine composition, described compositions is made oral formulations, preferred particulates agent, tablet, capsule, pill, powder, drop pill, syrup, mixture, distillate medicinal water, medicinal tea, sustained-release preparation and effervescent formulation.
According to foregoing Chinese medicine composition, described Chinese medicine composition can be made granule.
According to foregoing Chinese medicine composition, described compositions also contains dextrin and sucrose except active ingredient, and described dextrin content is 200-300 part, and described cane sugar content is 400-800 part.
According to foregoing Chinese medicine composition, described dextrin is 240 parts, and described sucrose is 600 parts.
According to foregoing Chinese medicine composition, described compositions also contains soluble starch or cyclamate, thus preparation no cane sugar type Chinese medicine composition, and described soluble starch content is 200-400 part; Cyclamate content is 5-15 part.
According to foregoing Chinese medicine composition, described soluble starch content is 300 parts; Described cyclamate content is 10 parts.
According to the preparation method of oral formulations noted earlier, its preparation process is:
A. extract: Rhizoma Chuanxiong, Radix Polygoni Multiflori Preparata, Fructus Crataegi, Radix Salviae Miltiorrhizae, Radix Curcumae are pulverized and sieve, mix homogeneously and decocting with water then, decoction liquor merges after-filtration, and filtrate is left standstill;
B. concentrate: get the supernatant of filtrate after leaving standstill, supernatant refilters, and the filtrate decompression after refiltering is condensed into thick paste;
C. mix: get Rhizoma Gastrodiae and become fine powder with other pharmaceutic adjuvant pulverize separately and sieve, with above-mentioned fine powder mix homogeneously, add above-mentioned thick paste, mix homogeneously, make granule, tablet, capsule, pill, powder, medicinal tea, sustained-release preparation or effervescent formulation according to conventional method, wherein preferably make granule;
Perhaps get Rhizoma Gastrodiae pulverize and sieve after fine powder, extract with 50% ethanol water, other pharmaceutic adjuvants of adding are made drop pill, syrup, mixture, distillate medicinal water according to conventional method then behind the extracting liquid filtering.
In this preparation method, wherein 5 flavor Chinese medicines are pulverized the remix extraction earlier, can increase extraction efficiency, reduce production costs.The inventor gropes through experiment repeatedly, has found a kind of method that water is decocted, and has avoided with an organic solvent the destruction to active ingredient, and has not reduced extraction effect.And Rhizoma Gastrodiae since its Main Ingredients and Appearance gastrodin meet thermoae volatile, so when preparing solid preparation, adopt direct mixed method and do not extract; And when the preparation liquid preparation, adopt 50% ethanol water, and extract down at 40 ℃, avoided the destruction of high temperature again to gastrodin, also increased extraction efficiency simultaneously.
According to the preparation method of oral formulations noted earlier, in the described preparation process:
A. sieve described in the extraction step to crossing 10 mesh sieves; Described amount of water is each 5-20 times of adding the Rhizoma Chuanxiong quality; Described decoction is for decocting 1-3 hour; Described filtrate is left standstill to leaving standstill 2-6 hour; Described being filtered into uses 120 mesh filter screens to filter;
B. be filtered into described in the concentration step and use 10 μ m filtering with microporous membranes; Described concentrating under reduced pressure concentrates at 80 ℃ for the control temperature; Described thick paste is 80 ℃ of thick pastes that following relative density is 1.1-1.5;
C. sieve described in the blend step to crossing 10 mesh sieves; Described 50% alcoholic solution is 10 times of Rhizoma Gastrodiae; Describedly be extracted as 40 ℃ and extract down; Described being extracted as extracted 1-2 hour; Described extracting liquid filtering was 10 μ m microporous filter membrane.。
In this preparation method, further limiting the decoction liquor filtration uses 10 μ m microporous filter membrane can remove all insoluble solid impurities, thereby the raising drug safety uses 120 mesh filter screens then can remove larger volume impurity earlier earlier, and avoids 10 μ m filter membranes to stop up.If concentration process concentrate moisture is too high among the step b, then thick paste can be crossed rare and be difficult to and the adjuvant mix homogeneously; If moisture is low excessively, equally also can increase mixing difficulty with adjuvant, can cause the concentrate local temperature to transfinite in addition and destroy active ingredient, through groping repeatedly, the inventor is limited to the thick paste relative density between the 1.1-1.5, can perfection address the above problem, and obtain the patent medicine of good appearance.
According to the preparation method of oral formulations noted earlier, in the described preparation process:
A. amount of water described in the extraction step be the Rhizoma Chuanxiong quality 10-15 doubly; Described leaving standstill to leaving standstill 4 hours;
B. thick paste described in the concentration step is 80 ℃ of thick pastes that following relative density is 1.25-1.30.
According to foregoing Chinese medicine composition, described Chinese medicine composition is used for the treatment of cardiovascular and cerebrovascular disease.
According to foregoing Chinese medicine composition, described cardiovascular and cerebrovascular disease symptom is dizzy, headache, cardiopalmus, insomnia, sensation of oppression over the chest with shortness of breath.
According to foregoing Chinese medicine composition, it can be specially described compositions and contain following component: 267 parts of Rhizoma Chuanxiongs, 167 parts of Radix Salviae Miltiorrhizaes, 100 parts of Radix Curcumaes, 200 parts of Fructus Crataegis, 213 parts of Radix Polygoni Multiflori Preparatas, 53 parts in Rhizoma Gastrodiae, 240 parts in dextrin, 600 parts of sucrose.
According to foregoing Chinese medicine composition, it can be specially described compositions and contain following component: 267 parts of Rhizoma Chuanxiongs, 167 parts of Radix Salviae Miltiorrhizaes, 100 parts of Radix Curcumaes, 200 parts of Fructus Crataegis, 213 parts of Radix Polygoni Multiflori Preparatas, 53 parts in Rhizoma Gastrodiae, 240 parts in dextrin.
According to foregoing Chinese medicine composition, it can be specially described compositions and contain following component: 267 parts of Rhizoma Chuanxiongs, 167 parts of Radix Salviae Miltiorrhizaes, 100 parts of Radix Curcumaes, 200 parts of Fructus Crataegis, 213 parts of Radix Polygoni Multiflori Preparatas, 53 parts in Rhizoma Gastrodiae, 600 parts of sucrose.
According to foregoing Chinese medicine composition, it can also be specially described compositions and contain following component: 267 parts of Rhizoma Chuanxiongs, 167 parts of Radix Salviae Miltiorrhizaes, 100 parts of Radix Curcumaes, 200 parts of Fructus Crataegis, 213 parts of Radix Polygoni Multiflori Preparatas, 53 parts in Rhizoma Gastrodiae, 300 parts of soluble starches, 10 parts of cyclamates.
According to foregoing Chinese medicine composition, it can also be specially described compositions and contain following component: 267 parts of Rhizoma Chuanxiongs, 167 parts of Radix Salviae Miltiorrhizaes, 100 parts of Radix Curcumaes, 200 parts of Fructus Crataegis, 213 parts of Radix Polygoni Multiflori Preparatas, 53 parts in Rhizoma Gastrodiae, 300 parts of soluble starches.
According to foregoing Chinese medicine composition, it can also be specially described compositions and contain following component: 267 parts of Rhizoma Chuanxiongs, 167 parts of Radix Salviae Miltiorrhizaes, 100 parts of Radix Curcumaes, 200 parts of Fructus Crataegis, 213 parts of Radix Polygoni Multiflori Preparatas, 53 parts in Rhizoma Gastrodiae, 10 parts of cyclamates.
According to the preparation method of Chinese medicine composition noted earlier, its preparation process can be specially:
A. extract: 267 parts of Rhizoma Chuanxiongs, 213 parts of Radix Polygoni Multiflori Preparatas, 200 parts of Fructus Crataegis, 167 parts of Radix Salviae Miltiorrhizaes, 100 parts of pulverize separately of Radix Curcumae are also crossed 10 mesh sieves, mix homogeneously and decocting with water then, amount of water is 10-15 a times of Rhizoma Chuanxiong quality, decocted 1-3 hour, decoction liquor merges the back filters with 120 mesh filter screens, and filtrate was left standstill 4 hours;
B. concentrate: get the supernatant of filtrate after leaving standstill, the institute's supernatant reuse of getting 10 μ m filtering with microporous membranes, 80 ℃ of concentrated concentrating under reduced pressure of filtrate become the thick paste of 80 ℃ of following relative densities at 1.1-1.5;
C. mix: get Rhizoma Gastrodiae and become fine powder with other adjuvant pulverize separately and cross 10 mesh sieves, with above-mentioned fine powder mix homogeneously, add above-mentioned thick paste, mix homogeneously, make granule, tablet, capsule, pill, powder, medicinal tea, sustained-release preparation or effervescent formulation according to conventional method, wherein preferably make granule; Perhaps get Rhizoma Gastrodiae pulverize and sieve after fine powder, extracted 1-2 hour down at 40 ℃ with 10 times of 50% ethanol water, extracting solution with 10 μ m filtering with microporous membranes after other pharmaceutic adjuvants of adding, make drop pill, syrup, mixture, distillate medicinal water according to conventional method then.
Chinese medicine composition of the present invention has following advantage:
(1) this compound preparation reasonable recipe, a few flavor medical materials complement each other, and have strengthened the therapeutic effect for cardiovascular and cerebrovascular disease greatly;
(2) except sophisticated process route, the present invention has also set up complete quality control system, and the composition quality of being produced is stable, safe, facilitate patients.
The specific embodiment
The following examples will be done to explain more specifically to the present invention, but the present invention is not limited only to these embodiment, and these embodiment do not limit the present invention in any way yet equally.
Embodiment 1
Prescription: Rhizoma Chuanxiong 267g, Radix Salviae Miltiorrhizae 167g, Radix Curcumae 100g, Fructus Crataegi 200g, Radix Polygoni Multiflori Preparata 213g, Rhizoma Gastrodiae 53g, dextrin 240g, sucrose 600g.
With the recipe quantity Rhizoma Chuanxiong, Radix Polygoni Multiflori Preparata, Fructus Crataegi, Radix Salviae Miltiorrhizae, the Radix Curcumae pulverize separately is also crossed 10 mesh sieves, mix homogeneously and decocting with water then, amount of water is 5 times of Rhizoma Chuanxiong quality, decocted 2 hours, decoction liquor is filtered with 120 mesh filter screens, filtrate was left standstill 4 hours, got the supernatant of filtrate after leaving standstill, the institute's supernatant reuse of getting 10 μ m filtering with microporous membranes, it is the thick paste of 1.25-1.30 that 80 ℃ of concentrated concentrating under reduced pressure of filtrate become 80 ℃ of following relative densities, get Rhizoma Gastrodiae and dextrin, the sucrose pulverize separately becomes fine powder and crosses 10 mesh sieves, with above-mentioned fine powder mix homogeneously, adds above-mentioned thick paste, mix homogeneously, make granule, be up to the standards after the drying, packing promptly gets the Chinese medicine composition finished product.
Embodiment 2
Prescription: Rhizoma Chuanxiong 267g, Radix Salviae Miltiorrhizae 167g, Radix Curcumae 100g, Fructus Crataegi 200g, Radix Polygoni Multiflori Preparata 213g, Rhizoma Gastrodiae 53g, soluble starch 300g, cyclamate 10g.
With the recipe quantity Rhizoma Chuanxiong, Radix Polygoni Multiflori Preparata, Fructus Crataegi, Radix Salviae Miltiorrhizae, the Radix Curcumae pulverize separately is also crossed 10 mesh sieves, mix homogeneously and decocting with water then, amount of water is 20 times of Rhizoma Chuanxiong quality, decocted 1 hour, decoction liquor is filtered with 120 mesh filter screens, filtrate was left standstill 4 hours, get the supernatant of filtrate after leaving standstill, the institute's supernatant reuse of getting 10 μ m filtering with microporous membranes, it is the thick paste of 1.25-1.30 that 80 ℃ of concentrated concentrating under reduced pressure of filtrate become 80 ℃ of following relative densities, get Rhizoma Gastrodiae and soluble starch, the cyclamate pulverize separately becomes fine powder and crosses 10 mesh sieves, with above-mentioned fine powder mix homogeneously, adds above-mentioned thick paste, mix homogeneously, make tablet by prior art, be up to the standards after the drying, packing promptly gets the Chinese medicine composition finished product.
Embodiment 3
Prescription: Rhizoma Chuanxiong 200g, Radix Salviae Miltiorrhizae 100g, Radix Curcumae 50g, Fructus Crataegi 100g, Radix Polygoni Multiflori Preparata 150g, Rhizoma Gastrodiae 30g, dextrin 200g, sucrose 500g.
With the recipe quantity Rhizoma Chuanxiong, Radix Polygoni Multiflori Preparata, Fructus Crataegi, Radix Salviae Miltiorrhizae, the Radix Curcumae pulverize separately is also crossed 10 mesh sieves, mix homogeneously and decocting with water then, amount of water is 10 times of Rhizoma Chuanxiong quality, decocted 3 hours, decoction liquor merges the back and filters with 120 mesh filter screens, filtrate was left standstill 2 hours, get the supernatant of filtrate after leaving standstill, the institute's supernatant reuse of getting 10 μ m filtering with microporous membranes, it is the thick paste of 1.10-1.20 that 80 ℃ of concentrated concentrating under reduced pressure of filtrate become 80 ℃ of following relative densities, get Rhizoma Gastrodiae and dextrin, the sucrose pulverize separately becomes fine powder and crosses 10 mesh sieves, with above-mentioned fine powder mix homogeneously, adds above-mentioned thick paste, mix homogeneously, make capsule according to a conventional method, be up to the standards, packing promptly gets the Chinese medicine composition finished product.
Embodiment 4
Prescription: Rhizoma Chuanxiong 300g, Radix Salviae Miltiorrhizae 180g, Radix Curcumae 120g, Fructus Crataegi 250g, Radix Polygoni Multiflori Preparata 200g, Rhizoma Gastrodiae 60g, cyclamate 13g
With the recipe quantity Rhizoma Chuanxiong, Radix Polygoni Multiflori Preparata, Fructus Crataegi, Radix Salviae Miltiorrhizae, the Radix Curcumae pulverize separately is also crossed 10 mesh sieves, mix homogeneously and decocting with water then, amount of water is 15 times of Rhizoma Chuanxiong quality, decocted 2 hours, decoction liquor is filtered with 120 mesh filter screens, filtrate was left standstill 6 hours, got the supernatant of filtrate after leaving standstill, the institute's supernatant reuse of getting 10 μ m filtering with microporous membranes, it is the thick paste of 1.30-1.50 that 80 ℃ of concentrated concentrating under reduced pressure of filtrate become 80 ℃ of following relative densities, get Rhizoma Gastrodiae and become fine powder with the cyclamate pulverize separately and cross 10 mesh sieves,, add above-mentioned thick paste above-mentioned fine powder mix homogeneously, mix homogeneously, make pill according to a conventional method, be up to the standards after the drying, packing promptly gets the Chinese medicine composition finished product.
Embodiment 5
Prescription: Rhizoma Chuanxiong 280g, Radix Salviae Miltiorrhizae 120g, Radix Curcumae 70g, Fructus Crataegi 280g, Radix Polygoni Multiflori Preparata 173g, Rhizoma Gastrodiae 40g, dextrin 270g, sucrose 700g.
With the recipe quantity Rhizoma Chuanxiong, Radix Polygoni Multiflori Preparata, Fructus Crataegi, Radix Salviae Miltiorrhizae, the Radix Curcumae pulverize separately is also crossed 10 mesh sieves, mix homogeneously and decocting with water then, amount of water is 9 times of Rhizoma Chuanxiong quality, decocted 3 hours, decoction liquor is filtered with 120 mesh filter screens, filtrate was left standstill 3 hours, get the supernatant of filtrate after leaving standstill, the institute's supernatant reuse of getting 10 μ m filtering with microporous membranes, it is the thick paste of 1.20-1.40 that 80 ℃ of concentrated concentrating under reduced pressure of filtrate become 80 ℃ of following relative densities, gets Rhizoma Gastrodiae and dextrin, the sucrose pulverize separately becomes fine powder and crosses 10 mesh sieves, with above-mentioned fine powder mix homogeneously, add above-mentioned thick paste, mix homogeneously, crushing screening is made powder according to a conventional method, be up to the standards, packing promptly gets the Chinese medicine composition finished product.
Embodiment 6
Prescription: Rhizoma Chuanxiong 220g, Radix Salviae Miltiorrhizae 150g, Radix Curcumae 80g, Fructus Crataegi 150g, Radix Polygoni Multiflori Preparata 160g, Rhizoma Gastrodiae 20g, Liquid Macrogol g.
With the recipe quantity Rhizoma Chuanxiong, Radix Polygoni Multiflori Preparata, Fructus Crataegi, Radix Salviae Miltiorrhizae, the Radix Curcumae pulverize separately is also crossed 10 mesh sieves, mix homogeneously and decocting with water then, amount of water is 18 times of Rhizoma Chuanxiong quality, decocted 1 hour, decoction liquor is filtered with 120 mesh filter screens, filtrate was left standstill 5 hours, get the supernatant of filtrate after leaving standstill, the institute's supernatant reuse of getting 10 μ m filtering with microporous membranes, 80 ℃ of concentrated concentrating under reduced pressure of filtrate become the thick paste of 80 ℃ of following relative density 1.10-1.30, get Rhizoma Gastrodiae pulverize and sieve after fine powder, 40 ℃ of extractions 2 hours down, extracting solution adds Polyethylene Glycol after with 10 μ m filtering with microporous membranes with 10 times of 50% ethanol water, mix homogeneously, make drop pill according to a conventional method, be up to the standards, packing promptly gets the Chinese medicine composition finished product.
Embodiment 7
Prescription: Rhizoma Chuanxiong 290g, Radix Salviae Miltiorrhizae 200g, Radix Curcumae 150g, Fructus Crataegi 300g, Radix Polygoni Multiflori Preparata 250g, Rhizoma Gastrodiae 70g, sucrose 1000g.
With the recipe quantity Rhizoma Chuanxiong, Radix Polygoni Multiflori Preparata, Fructus Crataegi, Radix Salviae Miltiorrhizae, the Radix Curcumae pulverize separately is also crossed 10 mesh sieves, mix homogeneously and decocting with water then, amount of water is 18 times of Rhizoma Chuanxiong quality, decocted 3 hours, decoction liquor is filtered with 120 mesh filter screens, filtrate was left standstill 6 hours, get the supernatant of filtrate after leaving standstill, the institute's supernatant reuse of getting 10 μ m filtering with microporous membranes, 80 ℃ of concentrated concentrating under reduced pressure of filtrate become the thick paste of 80 ℃ of following relative density 1.30-1.40, get Rhizoma Gastrodiae and become fine powder with the sucrose pulverize separately and cross 10 mesh sieves, extract 1 hour down at 40 ℃ with 10 times of 50% ethanol water, extracting solution adds above-mentioned fine powder mix homogeneously after with 10 μ m filtering with microporous membranes, add above-mentioned thick paste, mix homogeneously is made syrup according to a conventional method, be up to the standards, packing promptly gets the Chinese medicine composition finished product.
Embodiment 8
Prescription: Rhizoma Chuanxiong 210g, Radix Salviae Miltiorrhizae 150g, Radix Curcumae 60g, Fructus Crataegi 110g, Radix Polygoni Multiflori Preparata 160g, Rhizoma Gastrodiae 20g, cyclamate 5g.
With the recipe quantity Rhizoma Chuanxiong, Radix Polygoni Multiflori Preparata, Fructus Crataegi, Radix Salviae Miltiorrhizae, the Radix Curcumae pulverize separately is also crossed 10 mesh sieves, mix homogeneously and decocting with water then, amount of water is 7 times of Rhizoma Chuanxiong quality, decocted 2 hours, decoction liquor is filtered with 120 mesh filter screens, filtrate was left standstill 2 hours, got the supernatant of filtrate after leaving standstill, the institute's supernatant reuse of getting 10 μ m filtering with microporous membranes, 80 ℃ of concentrated concentrating under reduced pressure of filtrate become the thick paste of 80 ℃ of following relative density 1.20-1.30, get Rhizoma Gastrodiae and become fine powder with the cyclamate pulverize separately and cross 10 mesh sieves,, add above-mentioned thick paste above-mentioned fine powder mix homogeneously, mix homogeneously, make granule, be up to the standards after the drying, packing promptly gets the Chinese medicine composition finished product.
Embodiment 9
Prescription: Rhizoma Chuanxiong 260g, Radix Salviae Miltiorrhizae 120g, Radix Curcumae 80g, Fructus Crataegi 160g, Radix Polygoni Multiflori Preparata 190g, Rhizoma Gastrodiae 63g.
With the recipe quantity Rhizoma Chuanxiong, Radix Polygoni Multiflori Preparata, Fructus Crataegi, Radix Salviae Miltiorrhizae, the Radix Curcumae pulverize separately is also crossed 10 mesh sieves, mix homogeneously and decocting with water then, amount of water is 12 times of Rhizoma Chuanxiong quality, decocted 3 hours, decoction liquor is filtered with 120 mesh filter screens, filtrate was left standstill 5 hours, get the supernatant of filtrate after leaving standstill, the institute's supernatant reuse of getting 10 μ m filtering with microporous membranes, 80 ℃ of concentrated concentrating under reduced pressure of filtrate become the thick paste of 80 ℃ of following relative density 1.15-1.30, get Rhizoma Gastrodiae pulverize and sieve after fine powder, extracted 1 hour down at 40 ℃ with 10 times of 50% ethanol water, extracting solution with 10 μ m filtering with microporous membranes after the above-mentioned thick paste of adding, add other pharmaceutic adjuvant mix homogeneously, make distillate medicinal water according to a conventional method, after the assay was approved, packing promptly gets the Chinese medicine composition finished product.
Embodiment 10
Prescription: Rhizoma Chuanxiong 280g, Radix Salviae Miltiorrhizae 130g, Radix Curcumae 90g, Fructus Crataegi 130g, Radix Polygoni Multiflori Preparata 170g, Rhizoma Gastrodiae 30g.
According to adding suitable pharmaceutic adjuvant after the method extraction active ingredient noted earlier, way is made medicinal tea routinely, and after the assay was approved, packing promptly gets the Chinese medicine composition finished product.
Embodiment 11
Prescription: Rhizoma Chuanxiong 280g, Radix Salviae Miltiorrhizae 180g, Radix Curcumae 140g, Fructus Crataegi 270g, Radix Polygoni Multiflori Preparata 210g, Rhizoma Gastrodiae 50g.
According to adding suitable pharmaceutic adjuvant after the method extraction active ingredient noted earlier, way is made sustained-release preparation routinely, is up to the standards after the drying, and packing promptly gets the Chinese medicine composition finished product.
Embodiment 12
Prescription: Rhizoma Chuanxiong 230g, Radix Salviae Miltiorrhizae 130g, Radix Curcumae 80g, Fructus Crataegi 140g, Radix Polygoni Multiflori Preparata 173g, Rhizoma Gastrodiae 53g.
According to adding suitable pharmaceutic adjuvant after the method extraction active ingredient noted earlier, way is made effervescent formulation routinely, is up to the standards after the drying, and packing promptly gets the Chinese medicine composition finished product.
Embodiment 13
Usage and dosage: boiled water is taken after mixing it with water, a 15g, or a 7g (no sucrose), 3 times on the one; Or follow the doctor's advice.Be used for the treatment of the dizziness and headache that cardiovascular and cerebrovascular disease causes, palpitation and insomnia, sensation of oppression over the chest with shortness of breath.
Taboo: the anemia of pregnant woman prohibits clothes.
The obtained drug quality of the present invention is stable, and taking convenience has been formulated the strict quality standard.Now its discriminating, detection method are listed below in the lump as test example:
Test example 1
Character:
This product be pale brown color to brown granular, distinguish the flavor of sweet, little hardship or bitter in the mouth (no sucrose).
Test example 2
Assay:
Measure according to high performance liquid chromatography (first appendix VI of Chinese Pharmacopoeia version in 2000 D).
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Methanol-0.2mol/L Spirit of Mindererus. (regulating pH value to 2.2 with hydrochloric acid) (12: 88) is mobile phase; The detection wavelength is 316nm.Theoretical cam curve is calculated by the protocatechualdehyde peak should be not less than 3000.
The preparation of reference substance solution: it is an amount of that precision takes by weighing the protocatechualdehyde reference substance, adds formaldehyde and make the solution that every 1ml contains 40 μ g, promptly.
The preparation of need testing solution: get this product under the content uniformity item, porphyrize is got 5g or 3g (no sucrose), precision adds water 50ml, claim to decide weight, boiled 10 minutes, put cold, claim to decide weight again, add water and supply the weight that subtracts mistake, shake up, centrifugal, precision is measured supernatant 25ml, regulate pH value to 2 with dilute hydrochloric acid, extract 3 times, each 20ml with water saturated ethyl acetate jolting, merge ethyl acetate liquid, evaporate to dryness, residue add methanol make in right amount the dissolving and be transferred in the measuring bottle of 5ml, add methanol to scale, shake up, promptly.
Algoscopy: accurate respectively reference substance solution and each 10ml of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.
Test example 3
Differentiate:
(1) gets the need testing solution 4ml under " assay " item in " test example 2 ", be concentrated into 1ml, as need testing solution.Other gets the protocatechualdehyde reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw need testing solution 15ml, reference substance solution 5ml, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with chloroform-acetone-formic acid (8: 1: 1) is developing solvent, launch, take out, dry, spray is with the ferric chloride test solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(2) get this product 10g or 4.6g (no sucrose), porphyrize adds chloroform 20ml, and supersound process 30 minutes filters, and filtrate evaporate to dryness, residue add chloroform 1ml makes dissolving, as need testing solution.Other gets the emodin reference substance, and chlorination is copied into the solution that 1ml contains 0.5mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw need testing solution 10ml, reference substance solution 5ml, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, upper solution with petroleum ether (30～60 ℃)-methyl formate-formic acid (15: 5: 1) is developing solvent, launches, and takes out, dry, clear with ammonia steam smoke-dried beancurd to the speckle colour developing.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
Simultaneously, the inventor is listed below animal, the clinical trial of this medicine respectively, so that its safety and effectiveness are described.
Test example 1
The influence that medicine distributes to the rat brain blood flow:
With Chinese medicine composition composition granule of the present invention make 27g, 13.5% concentration liquid is stand-by.
Get 50 of rats, divide 5 groups at random, 10 every group, male and female half and half.That is: blank group (normal saline 2ml/100g.d), the high, medium and low dosage group of Chinese medicine composition of the present invention (10.8g, 5.4g, 2.7g/kg.d), positive drug group (DIAOXINXUE KANG 27mg/kg.d).5 groups of rats before ig gives test sample with 25% urethane ip anesthesia (1g/kg), by group, trace a rat left side (L), the right side (R) cerebral blood flow and blood flow distribution situation by a detection only with the RG-2B rheograph.Detect to finish, treat rat revive return to normal after, by test sample dosage ig administration 7d shown in above-mentioned.Behind last administration 30min, the same again method anesthesia, the RG-2B rheograph detects L, R cerebral blood flow and distribution situation.Check through t.The results are shown in Table 1.
Test example 2
Medicine is to the anoxybiotic influence of animal acute brain (head-breaking):
With Chinese medicine composition of the present invention make 39g, 19.5% concentration liquid is standby.
Get 50 of mices, divide 5 groups at random, 10 every group, male and female half and half.That is: blank group (normal saline 0.2ml/kg.d), the high, medium and low dosage group of Chinese medicine composition of the present invention (15.6g, 7.8g, 3.9g/kg.d), positive drug group (DIAOXINXUE KANG 39mg/kg.d).Below respectively organize the continuous 7d of mice ig administration, 1h after the last administration is by group by only breaking end observation, record mice broken end back mouth breathing number of times and breathing persistent period (s) rapidly.Check through t.The results are shown in Table 2.
Table 2, Chinese medicine composition of the present invention are to the protective effect of chmice acute cerebral ischemia (x ± s)
Compare with the blank group
*P＜0.05
The result shows; Chinese medicine composition object height of the present invention, middle dosage group and blank group relatively this test sample have significant difference (P＜0.05) to mice mouth breathing number of times, breathing persistent period, and cerebral ischemia has protective effect to Chinese medicine composition of the present invention to chmice acute.
Test example 3
Medicine is to the thrombotic influence of rat experiment (external neck A-V blood flow the method for bypass):
With Chinese medicine composition of the present invention make 27g, 13.5% concentration liquid is standby.
Get 40 of rats, divide 5 groups at random, 8 every group, male and female half and half.That is: blank group (normal saline 2ml/100g.d), the high, medium and low dosage group of Chinese medicine composition of the present invention (10.8g, 5.4g, 2.7g/kg.d), positive drug matched group (DIAOXINXUE KANG 27mg/kg.d).Below respectively organize rat by dosage ig administration shown in above-mentioned, 7d continuously is behind 60min after the last administration, with 25% urethane ip anesthetized rat (1g/kg).The careful skin of neck that cuts, pure property separation exposes neck A, neck V.Get long 50mm internal diameter 1mm polyethylene catheter two-section, one section of long 60mm internal diameter 2mm polyethylene catheter.The 1mm polyethylene catheter is inserted at internal diameter 2mm polyethylene catheter two ends, long and one on No. 4 silk threads of weighing of built-in 50mm, and conduit one end that links into an integrated entity inserts right neck A, an end inserts left V.Slowly open right neck A allows blood to circulate 15min through conduit, and folder closes right neck A, carefully extracts silk thread out and puts analytical balance and weigh.Wet weight of thrombus (mg)=gross weight-silk thread weight.And amount is decided thrombosis length (mm) one by one.Check through t.The results are shown in Table 3.
Table 3, Chinese medicine composition of the present invention are to the thrombotic influence of rat experiment (x ± s)
| Group | Number of animals (n) | Wet weight of thrombus (mg) | Thrombosis length (mm) |
| The low amount group positive drug group of amount group test product in the blank group test product a large amount group test product | 8 8 8 8 8 | 22.2±2.87 16.2±2.81 * 16.7±3.79 * 17.1±3.62 * 14.5±3.23 * | 64.9±2.90 58.6±2.32 59.3±2.05 61.2±3.24 56.9±1.81 * |
Compare with the blank group
*P＜0.05
The result shows, the wet weight of thrombus that Chinese medicine composition object height of the present invention, middle dosage group and blank group relatively form the bypass of rats in vitro neck A-V blood flow, thrombosis length form and suppress to have significant difference (P＜0.05), and Chinese medicine composition of the present invention is inhibited to rat experiment thrombosis.
Test example 4
Medicine is to the influence (pituitrin modelling) of Acute Myocardial Ischemia in Rats:
With Chinese medicine composition of the present invention make 27g, 13.5% concentration liquid is standby.
Select in advance 50 of the responsive rats that easily forms myocardial ischemia of pituitrin, divide 5 groups at random, 10 every group, male and female half and half.That is: blank group (normal saline 2ml/100g.d), the high, medium and low dosage group of Chinese medicine composition of the present invention (10.8g, 5.4g, 2.7g/kg.d), positive drug matched group (DIAOXINXUE KANG 27mg/kg.d).Below respectively organize rat by above-mentioned dosage ig administration, continuously 7d.Behind 60min after the last administration, fix by a waking state by group, connect precordial leads II, and tail vein injection pituitrin 0.5u/kg, 15sec has annotated.Record is given before the pituitrin and back 5～20s (first phase), and the ECG of 30s (second phase) J point and ST section occurs that following to accuse of a person be positive myocardial ischemia: 1. more than the J point rising 1.5mV; 2. the ST section is raised or level moves down 0.5mV, arrhythmia; 3. the T ripple hangs down flat (reducing former T wave height more than 50%), two-way, inversion.Through t check, x
2Check.The results are shown in Table 4, table 5.
Table 4, to the influence of Acute Myocardial Ischemia in Rats due to the pituitrin (x ± s)
Compare with the blank group
*P＜0.05
*P＜0.01
Test example 5
Medicine is to the hemorheological influence of microcirculation (Mice Auricle microcirculation method):
With Chinese medicine composition of the present invention make 39g, 19.5% concentration liquid is standby.
Get 50 of mices, divide 5 groups at random, 10 every group, male and female half and half.That is: blank group (normal saline 0.2ml/10g.d), the high, medium and low dosage group of Chinese medicine composition of the present invention (15.6g, 7.8g, 3.9g/kg.d), positive drug matched group (DIAOXINXUE KANG 39mg/kg.d).Below respectively organize mice by above-mentioned dosage ig administration 7d.Behind 1h after the last administration, ip25% urethane 1g/kg anesthesia, back of the body position is fixing, fill up auricle and flattened and be coated with cedar oil, place under the cold light source, measure Mice Auricle arteriole (A), venule (V) caliber (μ m) and little A, V blood flow rate (μ m/sec) by WX-6B type computer microcirculation analyzer.Through the t check, the results are shown in Table 6.
Table 6, to the hemorheological influence of Mice Auricle microcirculation (x ± s)
Compare with the blank group
*P＜0.05
The result shows that Chinese medicine composition of the present invention relatively has remarkable dilating effect (P＜0.05) to Mice Auricle arteriole (A), venule (V) caliber (μ m) with the blank group; Mice Auricle arteriole (A), venule (V) blood flow rate (μ m/sec) had remarkable improvement and facilitation (P＜0.05).
Test example 6
Medicine is to the influence (mice normal pressure resistant anoxia laboratory method) of the acute myocardial ischemia of animal:
With Chinese medicine composition of the present invention make 39g, 19.5% concentration liquid is standby.
Get 140 of male mices, divide 7 groups at random, 20 every group.That is: blank group (normal saline 0.2ml/10g.d.ig), isoproterenol group (ISO) (5mg/kg.d.Sc), Propranolol group (20mg/kg.d.ig), positive drug matched group (DIAOXINXUE KANG group 39mg/kg.d.ig), Chinese medicine composition object height of the present invention, middle dosage group (15.6g, 7.8g/kg.d.ig), Chinese medicine composition low dosage of the present invention+isoproterenol group (3.9g/kg.d.ig.Sc).Blank group, positive drug matched group, the high, medium and low dosage group of Chinese medicine composition of the present invention be respectively by dosage and administration shown in above-mentioned, continuously 7d.Each is organized behind last administration 30min, mice is pursued only put into the 250ml port grinding bottle of putting the 5g sodica calx respectively, the then 15min administration respectively before test of Chinese medicine composition of the present invention+isoproterenol group.Also respectively each group mice is pursued after the administration and only put into the 250ml port grinding bottle of putting the 5g sodica calx, bottle cap is airtight along evenly being coated with vaseline.Observe and write down each group by a mouse breathing dwell time with stopwatch,, the results are shown in Table 7 through the t check.
Table 7, medicine are to the influence of chmice acute myocardial ischemia death time (x ± s)
| Group | Number of animals (n) | The acute myocardial ischemia death time of normal pressure (min) |
| Low amount+ISO the group of amount group test product positive drug group in the blank group isoproterenol group Propranolol group test product a large amount group test product | 20 20 20 20 20 20 20 | 13.62±2.39 8.74±2.22 16.42±3.27 * 19.30±4.19 *△ 18.15±3.17 12.43±2.18 * 20.09±3.73 *△ |
Compare with the isoproterenol group
*P＜0.05
Compare △ P＜0.05 with the blank group
The result shows that high, medium and low dosage group of Chinese medicine composition of the present invention and isoproterenol group relatively show significant prolongation effect (P＜0.05) to the mice normal pressure acute myocardial ischemia death time.Chinese medicine composition of the present invention has the acute myocardial ischemia effect of anti-mice normal pressure.
Test example 7
The clinical drug experiment:
(1) clinical data:
The treatment group is included case 300 examples altogether in, includes case 100 examples in the matched group in, clinic case totally 278 examples in two groups, inpatient's 122 examples.Male patient's 157 examples, female patient 243 examples.
(2) case choice criteria:
The diagnostic criteria of traditional Chinese medical science disease is with reference to " disease of tcm is at the criterion of therapeutical effect " of State Administration of Traditional Chinese Medicine's issue in 1994.Disease: blood stasis liver-yang hyperactivity disease.
Primary symptom: dizzy, headache, cardiopalmus, insomnia, sensation of oppression over the chest with shortness of breath;
Inferior disease: flushing conjunctival congestion, numb limbs and tense tendons, bitter taste, constipation, purplish tongue have ecchymosis petechia, stringy and hesitant pulse.
(3) include standard in:
Meet the diagnostic criteria of traditional Chinese medical science disease; Age is in 18-65 year; After the morbidity not medication or take that treatment is dizzy, cardiopalmus class medicine but two week of drug withdrawal the back and symptom still do not have the person; Signature notice in the know.
Following situation is got rid of: merge have the inclination, brain, Liver and kidney and serious primary disease of hemopoietic system and psychotic; Allergic constitution or to drug allergy person; Gestation or women breast-feeding their children.
(4) curative effect determinate standard:
Clinic control: the clinical symptoms sign disappears or basic the disappearance, and the disease integration reduces 〉=95%;
Produce effects: clinical symptoms, sign are obviously improved, and the disease integration reduces 〉=70%;
Effectively: clinical symptoms, sign all take a favorable turn, and the disease integration reduces 〉=30%;
Invalid: clinical symptoms, sign do not have obvious improvement, even increase the weight of, the disease integration reduces less than 30%.
(5) method of administration:
The treatment group: take Chinese medicinal composition granules of the present invention, packed, a 15g/ bag, 3 times on the one, 30 days is a course of treatment.
Matched group: take XINNAOKANG JIAONANG, limited company produces by the luxuriant auspicious Pharmaceutical in Tonghua, and is oral, one time 4,3 times on the one, the 0.25g/ grain, 30 days is a course of treatment.
(6) efficacy result analysis:
Table 8, general curative effect comparative analysis
As can be seen from the above table, no significance meaning between liang group of P＞0.05.
Table 9, the state of an illness and efficacy analysis
As can be seen from the above table, the state of an illness and curative effect have evident difference, and statistical procedures result proves P＞0.05; The significance meaning is arranged.
(7) untoward reaction:
We take Chinese medicine composition of the present invention one course of treatment (30 days) by 300 routine patients and all find no any untoward reaction generation in clinical.Illustrate that it is reliable that this medicine uses clinically; Matched group also finds no any untoward reaction.
(8) brief summary:
We take Chinese medicine composition of the present invention one course of treatment (30 days) by 300 routine patients, Clinical results shows, Chinese medicine composition of the present invention is to diseases such as caused dizzy, the headache of blood stasis liver-yang hyperactivity, cardiopalmus, insomnia, sensation of oppression over the chest with shortness of breath, have significant curative effect, its total effective rate reaches 90.3%; The XINNAOKANG JIAONANG that matched group adopts Tonghua luxuriant auspicious Pharmaceutical limited company to produce, its total effective rate reaches 85%.The treatment group is excellent slightly than matched group.Learn by statistics and handle proof, no significance meaning P＞0.05.Two groups all find no untoward reaction and take place.Thereby illustrating that Chinese medicine composition of the present invention is safe in clinical practice, is the good medicine of treatment blood stasis liver-yang hyperactivity disease.
Claims (15)
1, a kind of Chinese medicine composition for the treatment of cardiovascular and cerebrovascular disease, it is characterized in that, described compositions is extracted preparation by following medicinal materials: Rhizoma Chuanxiong 200-300 part, Radix Salviae Miltiorrhizae 100-200 part, Radix Curcumae 50-150 part, Fructus Crataegi 100-300 part, Radix Polygoni Multiflori Preparata 150-250 part, Rhizoma Gastrodiae 20-70 part, and described part is weight portion;
Described compositions is made oral formulations, and described preparation of compositions step is:
A. extract: Rhizoma Chuanxiong, Radix Polygoni Multiflori Preparata, Fructus Crataegi, Radix Salviae Miltiorrhizae, Radix Curcumae are pulverized and sieve, mix homogeneously and decocting with water then, decoction liquor merges after-filtration, and filtrate is left standstill; Described sieving to crossing 10 mesh sieves; Described amount of water is each 5-20 times of adding the Rhizoma Chuanxiong quality; Described decoction is for decocting 1-3 hour; Described filtrate is left standstill to leaving standstill 2-6 hour; Described being filtered into uses 120 mesh filter screens to filter;
B. concentrate: get the supernatant of filtrate after leaving standstill, the supernatant of getting refilters, and the filtrate decompression after refiltering is condensed into thick paste; Described being filtered into used 10 μ m filtering with microporous membranes; Described concentrating under reduced pressure concentrates at 80 ℃ for the control temperature; Described thick paste is 80 ℃ of thick pastes that following relative density is 1.1-1.5;
C. mix: get Rhizoma Gastrodiae pulverize and sieve after fine powder, extract with 50% ethanol water, add above-mentioned thick paste and other pharmaceutic adjuvants behind the extracting liquid filtering, make drop pill, syrup, mixture, distillate medicinal water according to conventional method then; Described sieving to crossing 10 mesh sieves; Described 50% alcoholic solution is 10 times of Rhizoma Gastrodiae; Describedly be extracted as 40 ℃ and extract down; Described being extracted as extracted 1-2 hour; Described extracting liquid filtering was 10 μ m microporous filter membrane.
2, Chinese medicine composition according to claim 1 is characterized in that, in the described preparation process:
A. amount of water described in the extraction step be the Rhizoma Chuanxiong quality 10-15 doubly; Described leaving standstill to leaving standstill 4 hours;
B. thick paste described in the concentration step is 80 ℃ of thick pastes that following relative density is 1.25-1.30.
3, Chinese medicine composition according to claim 1 is characterized in that, described compositions is extracted preparation by following medicinal materials: 267 parts of Rhizoma Chuanxiongs, 167 parts of Radix Salviae Miltiorrhizaes, 100 parts of Radix Curcumaes, 200 parts of Fructus Crataegis, 213 parts of Radix Polygoni Multiflori Preparatas, 53 parts in Rhizoma Gastrodiae, described part is weight portion.
4, Chinese medicine composition according to claim 1 is characterized in that, described compositions is made granule, tablet, capsule, pill, powder, drop pill, syrup, mixture, distillate medicinal water, medicinal tea.
5, Chinese medicine composition according to claim 4 is characterized in that, described Chinese medicine composition is a granule.
6, Chinese medicine composition according to claim 1 is characterized in that, described compositions is made sustained-release preparation or effervescent formulation.
7, Chinese medicine composition according to claim 5 is characterized in that, described granule also contains dextrin and sucrose, and described dextrin content is 200-300 part; Described cane sugar content is 400-800 part.
8, Chinese medicine composition according to claim 7 is characterized in that, described dextrin content is 240 parts; Described cane sugar content is 600 parts.
9, Chinese medicine composition according to claim 5 is characterized in that, described granule also contains soluble starch or cyclamate, thus preparation no cane sugar type Chinese medicine composition, and described soluble starch content is 200-400 part; Cyclamate content is 5-15 part.
10, Chinese medicine composition according to claim 9 is characterized in that, described soluble starch content is 300 parts; Cyclamate content is 10 parts.
11, a kind of preparation method according to the described oral formulations of claim 1 is characterized in that, preparation process is:
A. extract: Rhizoma Chuanxiong, Radix Polygoni Multiflori Preparata, Fructus Crataegi, Radix Salviae Miltiorrhizae, Radix Curcumae are pulverized and sieve, mix homogeneously and decocting with water then, decoction liquor merges after-filtration, and filtrate is left standstill; Described sieving to crossing 10 mesh sieves; Described amount of water is each 5-20 times of adding the Rhizoma Chuanxiong quality; Described decoction is for decocting 1-3 hour; Described filtrate is left standstill to leaving standstill 2-6 hour; Described being filtered into uses 120 mesh filter screens to filter;
B. concentrate: get the supernatant of filtrate after leaving standstill, the supernatant of getting refilters, and the filtrate decompression after refiltering is condensed into thick paste; Described being filtered into used 10 μ m filtering with microporous membranes; Described concentrating under reduced pressure concentrates at 80 ℃ for the control temperature; Described thick paste is 80 ℃ of thick pastes that following relative density is 1.1-1.5;
C. mix: get Rhizoma Gastrodiae pulverize and sieve after fine powder, extract with 50% ethanol water, add above-mentioned thick paste and other pharmaceutic adjuvants behind the extracting liquid filtering, make drop pill, syrup, mixture, distillate medicinal water according to conventional method then; Described sieving to crossing 10 mesh sieves; Described 50% alcoholic solution is 10 times of Rhizoma Gastrodiae; Describedly be extracted as 40 ℃ and extract down; Described being extracted as extracted 1-2 hour; Described extracting liquid filtering was 10 μ m microporous filter membrane.
According to the preparation method of the described oral formulations of claim 11, it is characterized in that 12, step c is mixed into and makes granule.
13, according to the preparation method of the described oral formulations of claim 12, it is characterized in that, in the described preparation process:
A. amount of water described in the extraction step be the Rhizoma Chuanxiong quality 10-15 doubly; Described leaving standstill to leaving standstill 4 hours;
B. thick paste described in the concentration step is 80 ℃ of thick pastes that following relative density is 1.25-1.30.
14, Chinese medicine composition according to claim 1 is characterized in that, described Chinese medicine composition is used for the treatment of cardiovascular and cerebrovascular disease.
15, Chinese medicine composition according to claim 1 is characterized in that, described cardiovascular and cerebrovascular disease symptom is dizzy, headache, cardiopalmus, insomnia, sensation of oppression over the chest with shortness of breath.
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Non-Patent Citations (4)
| Title |
|---|
| 《国家中成药标准汇编》（中成药地方标准上升国家标准部分）脑系分册. 167－169，国家药监局. 2002 |
| 《国家中成药标准汇编》（中成药地方标准上升国家标准部分）脑系分册. 167－169，国家药监局. 2002 * |
| 天麻中有效成分的提取工艺. 王兴.华西药学杂志，第18卷第4期. 2003 |
| 天麻中有效成分的提取工艺. 王兴.华西药学杂志，第18卷第4期. 2003 * |
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Address after: 723000 Yingbin West Road, Hantai District (North Economic Development Zone), Hanzhong City, Shaanxi Province Patentee after: Shaanxi Hanwang Pharmaceutical Co., Ltd Address before: 723000 Yingbin Road, North Zone, Hanzhoung Economic Development Zone, Shaanxi Patentee before: Hanwang Pharmaceutical Industry Co., Ltd., Shanxi |
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