CN1403106A - Chinese medicine granule for treating cardiac and cerebral diseases and its prepn - Google Patents
Chinese medicine granule for treating cardiac and cerebral diseases and its prepn Download PDFInfo
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Abstract
The present invention is Chinese medicine granule for treating cardiac and cerebral diseases and its preparation process. The medicine is prepared with wheat, kudzuvine root, date, licorice and ginkgo leaf extract, and the preparation process includes twice decoction of wheat, kudzuvine root, date and licorice, filtering, merging filtrate, concentration, spray drying, mixing with ginkgo leaf extract, cane sugar and dextrin, pelletizing and other steps. The Chinese medicine granule has the functions of tranquilizing, relieving the gastric disorder and relaxing joints and muscles, and is used in treating depression, neurasthenia and climacteric syndrome.
Description
Technical field:
The present invention relates to a kind of Chinese patent medicine, be specifically related to a kind of Chinese medicinal granule for the treatment of cardio-cerebral diseases.
Background technology
Along with the development of society, people's life-span prolongs gradually and enters aging society, strengthens the research and the treatment of senile disease are more seemed very important.People's age climacteric is generally at 45-55 between year, though improvement along with the living condition, age prolongs after to some extent, but the quickening of rhythm of life, physical work are to the transformation of mental work, and the nervous psychology and the influence of physiological function factor, the sickness rate of senile disease is increased, as the women because of the climacteric syndrome due to the ovarian function decline with menstruation change, spiritual nervous function disorder and metabolic function disorder, be main syndrome.Patient's subjective symptoms is changeable, lasting over the years.The and for example aging of population, the sickness rate of cardio cerebral function aspect also increase greatly, the stress syndrome that brings as arteriosclerosis, cardiovascular and cerebrovascular disease, disordered brain function, intellectual function decline, alzheimer disease, insomnia and rhythm of life quickening etc.After above-mentioned these diseases took place, though chemicals has certain curative effect, poisonous side effect of medicine was big, take for a long time to make brain response blunt, even the grievous injury hepatic and renal function.And Chinese medicine has original advantage in this respect.Therefore, how to research and develop the Chinese patent medicine for the treatment of these cardio-cerebral diseases and become current urgent task and important problem.
Summary of the invention:
The present invention's purpose aims to provide a kind of Chinese medicinal granule with tranquilizing by nourishing the heart and middle emergency, dredge the meridian passage effect, the neurasthenia who is used for the treatment of the liver depression of having a guilty conscience, climacteric syndrome and preparation method thereof.
Technical solution of the present invention is: the Chinese medicinal granule of this treatment cardio-cerebral diseases is prepared from by following component components by weight percentage: Semen Tritici aestivi 29-37%, Radix Puerariae 29-37%, Fructus Jujubae 14-18%, Radix Glycyrrhizae 14-18%, Folium Ginkgo extract powder 0.1-1%.
The Chinese medicinal granule its preparation method of above-mentioned treatment cardio-cerebral diseases is: will decoct with water twice by Semen Tritici aestivi, Radix Puerariae, Fructus Jujubae, the Radix Glycyrrhizae that above-mentioned percentage by weight is weighed, and add 4 times in water at every turn, each little boiling 2 hours, extract medicinal liquid out, merge the decoction medicinal liquid, filter, relative density was the thick paste of 1.05-1.10 when filtrate decompression was concentrated into 85 ℃ of heat surveys, spray drying gets dry powder, Folium Ginkgo extract powder that the adding precentagewise is weighed and an amount of sucrose, dextrin, mixing, granulate, drying, granulate, promptly.
The Chinese medicinal granule of treatment cardio-cerebral diseases of the present invention is made up of Semen Tritici aestivi, Fructus Jujubae, Radix Glycyrrhizae, Radix Puerariae, Folium Ginkgo.Modern pharmacological research shows, Chinese medicinal granule of the present invention shortens the pentobarbital sodium dropping asleep latency and prolongs the length of one's sleep the mice number of times that can significantly take in sail, and has tranquilizing effect, can reduce dysmnesia animal errors number and prolong error latence, have nootropic effect; Pathological changes such as the caused brain capillary permeability of experimental cerebral ischemia increases can obviously be alleviated, have brain strengthening function; Can significantly suppress to enrage state, Radix Puerariae, Folium Ginkgo have the obvious gain effect to cerebral blood circulation and brain cell energy metabolism, and as strengthening normal person's memory, it is disorderly as understanding, hypomnesis, affective disorder etc. to improve elderly cerebral.
The agitation insomnia that the Chinese medicinal granule of treatment cardio-cerebral diseases of the present invention causes a variety of causes, hypomnesis, neurasthenia, climacteric syndrome etc. have curative effect preferably.The present invention has designed the feasible and stable technological process of production.By quality standard research has been done in the qualitative evaluation of Radix Puerariae, Radix Glycyrrhizae, and main effective ingredient puerarin in the Radix Puerariae has been carried out quantitative study.Methodological study shows that its content control method is simple, reliable, and the response rate and repeatability are good.Stability observing shows that after this product was stored 18 months under field conditions (factors), its character, moisture, granularity, discriminating, content and health examination did not all have significant change, and " the Chinese pharmacopoeia standard exports the quality standard of this product to meet 2000.Pharmacodynamic study shows, this product compares with " Naolejing ", can significantly reduce the animal activity number of times, can shorten simultaneously the pentobarbital sodium dropping asleep latency and prolong the length of one's sleep, prompting has tranquilizing effect, results of comparison is represented (P＜0.05): compare with " GUHAN YANGSHENG JING ", error latence, can be prolonged, prompting has the mouse memory power function of enhancing and effect, results of comparison is represented (P＜0.05): compare with " powerful brain heart health ", this product is there was no significant difference aspect anoxia enduring, but can alleviate due to the cerebral ischemia pathological change such as capillary permeability enhancing, and prompting has brain-invigorating.Above-mentioned pharmacodynamic experiment research provides abundant foundation for promoting blood circulation to remove obstruction in the collateral, tranquilizing by nourishing the heart, the brain healthy effect of this product.Acute toxicity testing shows that maximum this product toxicity LD50 that limits the quantity of can not survey; Long term toxicity test adopts 27.75 times of administrations of the suitable clinical dosage of rat three months, every index there is no obvious adverse reaction, show under clinical recommended dose it is safe, by the check to continuous three batch samples, every index all meets the requirement of drug standard.Clinical research shows that this medicine is treated the neurasthenia of melancholia that has a guilty conscience, the total effective rate of climacteric syndrome is 86.7%, total obvious effective rate is 55%, " " (76.67%, 25%), clinical taking do not seen untoward reaction in 30 days to Naolejing simultaneously apparently higher than positive controls.
Component pharmacology analysis of the present invention:
Semen Tritici aestivi: the sweet in the mouth cold nature, go into heart spleen kidney channel.Tranquilizing by nourishing the heart, beneficial heart cough-relieving are arranged, end sweating due to debility and the effect of heat clearing away and restlessness relieving." book on Chinese herbal medicine is new again " " nourish heart, kidney tonifying and blood, spleen invigorating ".Be that ancient Chinese medicine doctor is used for tranquilizing by nourishing the heart, tonify deficiency antisudorific key medicine.
Radix Puerariae: Gan Xinping goes into the taste warp.Yang invigorating expelling pathogenic factors from muscles, relieving restlessness effect such as quench the thirst is arranged." Japan hanako materia medica " " control septum pectorale heat, vexed sultry mad ..., ", according to modern study: Radix Puerariae has special efficacy to cardio-cerebral diseases, angina pectoris etc.The flavone that extracts in the Radix Puerariae and other compositions can increase brain and arteria coronaria blood flow, can improve cerebral circulation to hypertension, arteriosclerosis person.
More than two flavor medicines, simply tranquilizing by nourishing the heart, kidney tonifying, end sweating due to debility; Relieving restlessness is quenched the thirst simply, improves brain and arteria coronaria blood flow, and common synergism is a good medicine.
Fructus Jujubae: sweet in the mouth is flat, goes into the taste warp, has spleen reinforcing stomach function regulating, beneficial intestinal to promote the production of body fluid, transfer effects such as battalion defends." system record " " invigorating the spleen and replenishing QI, brute force are removed unhappiness, and it is outstanding down to treat the heart ....”
Radix Glycyrrhizae; Sweet flat, go into taste lung footpath.Have and effects such as middle emergency, lung moistening detoxifcation." system record " " therapeutic method to keep the adverse QI flowing downwards in the reason, stuffy sensation with restlessness is losed heart ...." " book on Chinese herbal medicine of solar corona "." the peace soul decide soul, and the benefit five kinds of strain and seven kinds of impairment, all are deficient, unhappy, forgetful ... "
The sweet property of above-mentioned two flavor flavour of a drug is flat, has tonifying the spleen and stomach and middle emergency, and effects such as relieving restlessness are ministerial drug.
Folium Ginkgo: first year " Bencao Pinhui Jingyao " sweet in the mouth of this product bitterness, property are put down, has the effect that the beneficial heart is astringed the lung, be suitable for pained, severe palpitation ... (seeing " Chinese medicinal herbal "), modern study this product extract can dilating coronary blood vessel, reduce serum cholesterol, improve effects such as serum cholesterol and phospholipid ratio, the collaborative above four Chinese medicine thing benefit heart is arranged, effect such as calm the nerves is adjuvant drug.
This product is by clinical practice, proof has therapeutical effect preferably for neurasthenia, the nervus cardiacus functional disease of hysteria one climacteric syndrome and the stagnation of liver-QI of having a guilty conscience, observe simultaneously and find, certain auxiliary treatment effect is arranged also belonging to the cardiovascular disease of the stagnation of liver-QI of having a guilty conscience.
" curing mainly relevant Pharmacodynamic test of active extract data and documents and materials with function " literary composition describes the test objective of the Chinese medicinal granule of this treatment cardio-cerebral diseases in detail, test material comprises medicine, animal, this Chinese medicinal granule is to the influence of mice autonomic activities, this Chinese medicinal granule is to the influence of pentobarbital sodium in mice sleep effect, this Chinese medicinal granule is to the influence of learning and memory of little mouse function, this Chinese medicinal granule is to the influence of mice hypoxia endurance time, this Chinese medicinal granule is to the influence of white mice cerebral index and brain capillary permeability, this Chinese medicinal granule enrages the influence of behavior to mice.Result of the test shows that granule of the present invention has following pharmacological action:
1, behind oral Chinese medicine of mice, the number of times that can significantly take in sail shortens the pentobarbital sodium dropping asleep latency and prolongs the length of one's sleep, has tranquilizing effect.
2, behind the mice oral Chinese medicine,, and the caused brain capillary permeability of experimental cerebral ischemia the increases pathological change of etc.ing can obviously be alleviated, point out this product to have brain strengthening function normal pressure hypoxia endurance time and experimental ischemia index is not had obvious variation.
3, behind oral Chinese medicine of mice, can reduce dysmnesia animal errors number and prolong error latence, have nootropic effect.
4, behind oral Chinese medicine of mice, can significantly suppress to enrage state.
" long-term toxicity test for animals data and documents and materials " literary composition describes test objective of the present invention in detail, experiment material, experimental technique and result comprise animal grouping and dosage, route of administration and method, detect index, detection time and convalescent period observe, experimental result, conclusion is: a large amount of these granules (20 of ig, 60g/kg) 25 of the suitable clinical dosage of difference, 75 times, continuous three months, outward appearance sign and behavioral activity to rat, food-intake, defecation, body weight, routine blood test, blood parameters, the organ coefficient of main organs and histopathologic examination there is no tangible untoward reaction.Therefore granule toxicity of the present invention is less, and it is safe using under the dosage of clinical recommendation.
" acute toxicity test data and documents and materials " literary composition describes test objective, experiment material, experimental technique and result and acute toxicity test report in detail.Conclusion is: this Chinese medicinal granule toxicity is less, and it is safe using when the dosage of clinical recommendation.
" physicochemical property research data and the documents and materials relevant with quality " literary composition describes the research data of the documents and materials of prescription main chemical compositions of taste of Chinese medicine and physicochemical property and discriminating, main reference bibliography, the physicochemical property relevant with quality in detail.
The specific embodiment:
Embodiment 1:
Prescription:
Semen Tritici aestivi 889g Radix Puerariae 889g
Fructus Jujubae 444g Radix Glycyrrhizae 444g
Folium Ginkgo extractum 13.9g (being equivalent to the about 2222mg of total flavones)
In [method for making] above five tastes, Semen Tritici aestivi, Radix Puerariae, Fructus Jujubae, Radix Glycyrrhizae four flavors decoct with water twice, add 4 times in water for the first time, add 4 times in water, each 2 hours for the second time.Extract medicinal liquid out, merge the decoction medicinal liquid, filter, filtrate decompression is concentrated into the thick paste that relative density is about 1.05-1.10 (85 ℃ of heat are surveyed), spray drying, get dry powder, add Folium Ginkgo extract powder, sucrose 390g, dextrin 130g, mixing is granulated, drying, granulate is made 1000g, promptly approximately.
[character] this product is a brown yellow granule, sweet, little bitterness of distinguishing the flavor of.
This product 1g is got in [discriminating] (1), adds methanol 20ml, and reflux 1 hour is put coldly, filters, filtrate evaporate to dryness, residue add water 20ml makes dissolving, uses n-butanol extraction 2 times, each 20ml, merge n-butanol extracting liquid, put evaporate to dryness in the water-bath, residue adds dehydrated alcohol 1ml makes dissolving, as need testing solution.Other gets Radix Puerariae control medicinal material 1g, shines medical material solution in pairs with legal system.It is an amount of to get the puerarin reference substance again, adds ethanol and makes the solution that contains 0.4mg among every 1ml, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw above-mentioned three kinds of each 2ul of solution, put respectively on same silica gel g thin-layer plate, lower floor's solution with chloroform-methanol-water (78: 35: 10) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (254nm) and inspect.In the test sample chromatograph, with reference substance and the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(2) get this product 5g, the 40ml that adds diethyl ether, supersound process 10 minutes filters, and discards ether solution, and medicinal residues add the n-butyl alcohol supersound process 2 times after volatilizing ether, add n-butyl alcohol 20ml supersound process 10 minutes at every turn.Merge n-butyl alcohol liquid, put evaporate to dryness in the water-bath, residue adds ethanol 1ml makes dissolving, as need testing solution.Extracting liquorice control medicinal material 1g shines medical material solution in pairs with legal system in addition.According to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B) test, draw above-mentioned two kinds of each 5ul of solution, put respectively on same silica gel g thin-layer plate, (15: 1: 1: lower floor's solution 2) was developing solvent with ethyl acetate-formic acid-ice vinegar-acid-water, launch, take out, dry.Spray is with 10% ethanol solution of sulfuric acid, put 105 ℃ dry by the fire to the speckle colour developing clear.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
[inspection] should meet the relevant every regulation under the granule item.(an appendix I of the yellow version in 2000 of middle traditional Chinese medicines C)
[assay] gets content under the content uniformity item, mixing, porphyrize.Get about 1.5g, the accurate title, decide, and puts in the apparatus,Soxhlet's, add methanol 60ml heating extraction 3 hours, extracting solution evaporate to dryness, residue add water 40ml makes dissolving, in order to water saturated n-butanol extraction 4 times, each 20ml merges n-butanol extracting liquid, puts evaporate to dryness in the water-bath, residue also all is transferred in the 10ml measuring bottle with dehydrated alcohol gradation dissolving, add dehydrated alcohol and be diluted to scale, shake up, as need testing solution.Other gets the puerarin reference substance, adds ethanol and makes the solution that contains 1mg among every 1ml, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw need testing solution 2ul, reference substance solution 2ul, 4ul difference cross point is on same silica gel g thin-layer plate, lower floor's solution with chloroform-methanol-water (78: 35: 10) is developing solvent, launch, take out, dry, put location under the ultra-violet lamp (254nm).Scan wavelength according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B thin layer chromatography scanning): λ=255nm, measure test sample trap integrated value and reference substance trap integrated value, calculate promptly.
The every 1g of this product contains Radix Puerariae and calculates with puerarin (C21H20O9), must not be less than 6.5mg.
[effect and purposes] tranquilizing by nourishing the heart and middle emergency, dredge the meridian passage.Be used to the to have a guilty conscience neurasthenia of liver depression, climacteric syndrome.
[usage and consumption] is oral, a 9g, 2 times on the one.
[specification] every packed 9g.
Dry place is put in [storage] sealing.
Embodiment 2:
(1) gets Semen Tritici aestivi 288kg, Radix Puerariae 288kg, Fructus Jujubae 144kg, Radix Glycyrrhizae 144kg puts and extracts in the extraction pot twice, add water 3500kg (about 4 times), extracting temperature is 95 ℃-100 ℃ at every turn, boiling back timing, little the boiling two hours of each maintenance, extract medicinal liquid out, the united extraction medicinal liquid filters, filtrate decompression is concentrated into the thick paste that relative density is about 1.05-1.10 (85 ℃ of heat are surveyed), and spray drying gets 147.4kg dried cream powder (receiving cream rate about 17%).
(2) the 147.4kg dried cream powder is sieved, add Folium Ginkgo extract powder 4.5kg, cane sugar powder 126.4kg, dextrin 42.1kg fully stirs, granulates, drying, granulate, sampling observation, pouch-packaged makes the granule of every bag of medicine 9g.
The invention is not restricted to above-mentioned two embodiment.
Claims (2)
1, a kind of Chinese medicinal granule for the treatment of cardio-cerebral diseases is characterized in that being prepared from by following component components by weight percentage: Semen Tritici aestivi 29-37%, Radix Puerariae 29-37%, Fructus Jujubae 14-18%, Radix Glycyrrhizae 14-18%, Folium Ginkgo extract powder 0.1-1%.
2, according to the preparation method of the Chinese medicinal granule of the treatment cardio-cerebral diseases of claim 1, it is characterized in that Semen Tritici aestivi, Radix Puerariae, Fructus Jujubae, Radix Glycyrrhizae that components by weight percentage is weighed decoct with water twice, add 4 times in water at every turn, each little boiling 2 hours, extract medicinal liquid out, merge the decoction medicinal liquid, filter, relative density was the thick paste of 1.05-1.10 when filtrate decompression was concentrated into 85 ℃ of heat surveys, spray drying, get dry powder, Folium Ginkgo extract powder that adding precentagewise proportioning is weighed and an amount of sucrose, dextrin, mixing, granulate, drying, granulate, promptly.
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| CNB011286032A CN1168465C (en) | 2001-09-18 | 2001-09-18 | Chinese medicine granule for treating cardiac and cerebral diseases and its prepn |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102423037A (en) * | 2011-10-14 | 2012-04-25 | 安徽省农业科学院农产品加工研究所 | Health-preserving porridge for improving climacteric syndrome and preparation process thereof |
| CN108310261A (en) * | 2018-05-10 | 2018-07-24 | 湖南康尔佳制药股份有限公司 | A kind of five-medicine tranquilization particle and preparation method thereof |
| CN108452203A (en) * | 2018-05-10 | 2018-08-28 | 湖南康尔佳制药股份有限公司 | A kind of preparation method and its preparation system of five-medicine tranquilization particle |
| CN111905061A (en) * | 2020-07-02 | 2020-11-10 | 江苏康缘美域生物医药有限公司 | Composition for nourishing female ovary and resisting aging and preparation method thereof |
-
2001
- 2001-09-18 CN CNB011286032A patent/CN1168465C/en not_active Expired - Fee Related
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102423037A (en) * | 2011-10-14 | 2012-04-25 | 安徽省农业科学院农产品加工研究所 | Health-preserving porridge for improving climacteric syndrome and preparation process thereof |
| CN108310261A (en) * | 2018-05-10 | 2018-07-24 | 湖南康尔佳制药股份有限公司 | A kind of five-medicine tranquilization particle and preparation method thereof |
| CN108452203A (en) * | 2018-05-10 | 2018-08-28 | 湖南康尔佳制药股份有限公司 | A kind of preparation method and its preparation system of five-medicine tranquilization particle |
| CN111905061A (en) * | 2020-07-02 | 2020-11-10 | 江苏康缘美域生物医药有限公司 | Composition for nourishing female ovary and resisting aging and preparation method thereof |
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| Publication number | Publication date |
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| CN1168465C (en) | 2004-09-29 |
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