CN1111054C - Medicine for treating apoplexy and its preparing process - Google Patents
Medicine for treating apoplexy and its preparing process Download PDFInfo
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Abstract
The present invention provides a Chinese medicine preparation for treating apoplexy, which is scientifically prepared from 13 kinds of traditional Chinese medicines including red ginseng, notoginseng, Chinese angelica root, spatholobus stem, red sage root, safflower, ginkgo leaves, haw, chrysanthemum, abalone shell, fleece-flower root, grassleaved sweetflag rhizomea and pueraria root according to the theory of traditional Chinese medicine and pharmacy. The present invention has the production method that the 13 kinds of traditional Chinese medicines are extracted by alcohol, water, etc. to be made into capsules or granules, oral liquid and tablets according to the modern pharmaceutical production process. The present invention has the efficiency of supplementing qi and activating blood circulation, dispersing blood stasis and dredging meridians, calming wind and eliminating phlegm for resuscitation. The present invention can also have the efficiency of inhibiting and eliminating atherosclerosis, inhibiting high cholesterin and hyperlipemia, promoting blood circulation, dissolving thrombus, resisting brain blood vessel ageing, etc. The present invention is mainly used for treating ischemic apoplexy (cerebral infarction), qi deficiency and blood stasis symptoms of apoplexy involving both collateral and meridian in a restoration stage and meridian occlusion caused by wind phlegm and blood stasis, and can also be used for the early stage of the acute stage of ischemic apoplexy. The present invention has the advantages of conspicuous curative effect, broad disease spectrum and radical treatment.
Description
The present invention relates to a kind of medicine for the treatment of apoplexy, particularly relate to the medicine and the production method thereof for the treatment of the apoplex involving the channels and collaterals apoplexy.
Apoplexy is the general designation of acute cerebrovascular disease, can be divided into cerebral infarction and hemorrhagic apoplexy two big classes.Cerebral infarction claims cerebral infarction again, can be divided into two kinds of cerebral thrombosis and cerebral embolism, they are because the atherosis tube chamber that makes of arteries of domination brain narrows down, add that slow blood flow, blood stickingly increase, changes of blood compendency, thrombosis etc. cause brain local vascular obstruction, make local brain tissue blood supply minimizing and ischemia causes disordered brain function.The hemorrhagic apoplexy main diseases because of with pathologic basis be atherosclerosis and hypertension.Cerebral infarction in the clinical treatment (cerebral infarction) is more to be seen, accounts for 80% of apoplexy morbidity,, wherein see so that the cerebral thrombosis disease more again, account for the 50-60% of apoplexy morbidity; Hemorrhagic apoplexy accounts for 20% of apoplexy morbidity, with hypertensive cerebral hemorrhage for seeing more.In addition, people also divide transient ischemic attack (transient apoplexy) into the cerebral infarction scope, and transient apoplexy is the tendency disease of apoplexy or the early symptom of apoplexy, and clinical research shows has 30% transient apoplexy patient in 3 years completed stroke can take place approximately.Transient apoplexy mostly occurs the people more than 40 years old, and apoplexy mostly occurs the people more than 50 years old.
China tradition traditional Chinese medical science has a lot of treatises to the treatment of apoplexy, has also put down in writing the Chinese medicinal formulae of many treatment apoplexy, and these prescriptions are one of China's pools of traditional Chinese medicine important compositions according to the different syndromes of apoplexy and different.The ancient Chinese medicine theory is fully being summed up, excavating and utilized to the modern Chinese medicine theory also, many internal medicine treatises have also proposed the method and the medicine of a large amount of Chinese traditional treatment apoplexy, " diagnosis and treatment of tcm internal medicine emergency case " (yellow star wall chief editor) as People's Health Publisher's publication in 1985, just introduced from what paleocurrent handed down and gone into some prescriptions of network, wind-yang and up-boring, excess syndrome of stroke, depletion syndrome sequela, the Chinese traditional treatment apoplexy has been played directive function preferably at wind-phlegm.Serve the Chinese patent medicine that pharmaceutical factory and Chinese medicine research department have also released some treatment apoplexy this year, as RONGSHUAN JIAONANG, ANSHEN BUNAO YE, XINGNAOJING ZHUSHEYE etc., but the price that these Chinese medicines have is higher, patient is difficult to accept, the specific aim that has is not strong, curative effect only plays the auxiliary treatment effect not as people's will.
Chinese patent also discloses the medicine and the production method thereof of some treatment apoplexy, and as 88108069, disclosing with the Radix Astragali, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Pheretima, Semen Persicae, Flos Carthami is the prescription of raw material; 93100576 disclose with Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Flos Carthami, Caulis Spatholobi, Radix Clematidis, Serpentis muscle grass, Caulis Lonicerae, Radix Cyathulae, Fructus Chaenomelis, Pheretima, Bombyx Batryticatus, Eupolyphaga Seu Steleophaga, gold exhaust, to spend tongue etc. in vain be the medicine of raw material for treating apoplexy for Scolopendra, Semen Persicae, Fructus Leonuri, money; 93106630 also to disclose with Radix Puerariae, Rhizoma Acori Graminei, Arisaema Cum Bile, Concretio Silicea Bambusae, Radix Polygalae, Radix Curcumae, Herba Dendrobii, Bulbus Fritillariae Cirrhosae, Radix Saposhnikoviae, Hirudo, Fructus Crataegi, Rhizoma Typhonii, the Rhizoma Pinelliae, Rhizoma Gastrodiae, Bombyx Batryticatus, Rhizoma Et Radix Notopterygii, Concha Margaritifera, Exocarpium Citri Grandis, Rhizoma Coptidis, Sargassum, Borneolum Syntheticum, Radix Notoginseng, Radix Rehmanniae Preparata, Fructus Lycii, Rhizoma Dioscoreae be the medicine of raw material for treating apoplexy; 95112187 to disclose with winter folium mori, Flos Chrysanthemi, Radix Salviae Miltiorrhizae, Fructus Crataegi, Radix Puerariae, Radix Polygoni Multiflori, Fructus Lycii, Ganoderma Lucidum, RHIZONA GASTRODIAE, Semen Cassiae be the medicine of raw material for treating apoplexy.The composition that above-mentioned disclosed these medicines have is too complicated, needs tens kinds of Chinese medicines to make up, and the cost that has is too high, and the curative effect that has is remarkable inadequately, thereby it is promoted the use of and is subjected to certain limitation.
The purpose of this invention is to provide a kind of to the apoplexy cause of disease is with strong points, evident in efficacy, prescription is uncomplicated, moderate, be Chinese patent medicine and the production method thereof that cerebral embolism apoplexy and meridians syndrome of blood stasis due to qi deficiency among convalescent period, wind-phlegm blood stasis, impatency venation card have significant curative effect to cerebral ischemia.
The inventor is in secular medical practice, from motherland's traditional medical theory, through research for many years, tens kinds of Chinese medicinal formulaes have been screened, compare repeatedly, therefrom choose some medicines and prescription, carried out pharmacodynamics, the pharmacology, and research experiment such as clinical, finally invented a kind of good effect, the medicine source is extensive, moderate, the advanced feasible Chinese patent medicine of production technology, the main active ingredient and the weight content of its raw material are as follows: Radix Ginseng Rubra 6.05～15.8 Radix Notoginseng 8.95～10.08 Radix Angelicae Sinensis 5.12～8.34 Caulis Spatholobis 7.76～8.97 Radix Salviae Miltiorrhizaes 8.01～11.3 Flos Carthamis 5.18～8.84 Folium Ginkgos 8.87～10.11 Fructus Crataegis 7.76～8.55 Flos Chrysanthemis 5.78～6.89 Concha Haliotidis 5.80～6.53 Radix Polygoni Multiflori 7.77～8.84 Rhizoma Acori Graminei 5.03～5.74 Radix Puerariaes 7.56～8.65
Above-mentioned Chinese medicine can from " find its another name, latin name and the place of production, usage Chinese pharmacopoeia and other Chinese medicine handbook, in order to understand the mechanism that the present invention treats disease, existing respectively distinguish the flavor of in the prescription effect of Chinese medicine and the effect in prescription thereof be described below:
The Radix Ginseng Rubra strongly invigorating primordial QI, invigorating the spleen to benefit the lung, the beneficial blood that promotes the production of body fluid, tranquilizing the mind; The Radix Notoginseng benefiting vital QI and blood reduces phlegm and promotes blood circulation; Two medicines share qi-supplementing, blood-engendering, blood stasis dispelling is promoted blood circulation with Zhi Qiben, are monarch drug altogether.Chinese angelica blood supplementing is invigorated blood circulation, and for controlling the key medicine of blood deficiency stasis, the Radix Salviae Miltiorrhizae bitter in the mouth is slightly cold, nourishing blood and promoting blood circulation, and dissipating blood stasis stimulates the menstrual flow, clearing away heart-fire for tranquillization; The Caulis Spatholobi promoting the circulation of blood is enriched blood, soothing the channels and quicking the network vessels; Folium Ginkgo blood circulation promoting and blood stasis dispelling, Fructus Crataegi give birth to circulation of qi promoting knot, dissipating blood stasis blood, and medicine-feeding is share, and are total to the principal drug assistance blood circulation promoting and blood stasis dispelling, and dredge the meridian passage is ministerial drug altogether.Flos Chrysanthemi clearing away liver-fire, suppressing the hyperactive liver sun, put out liver-wind; The Concha Haliotidis salty in the mouth is cold in nature, liver heat removing tonifying YIN, suppressing the hyperactive liver and subsiding YANG; Radix Polygoni Multiflori system usefulness, invigorating the liver and kidney, benefiting essence-blood, YIN nourishing press down sun; Rhizoma Acori Graminei is eliminated phlegm for resuscitation, the refreshment brain-strengthening.Four medicines share, and nourishing YIN for suppressing the hyperactive YANG, suppressing the hyperactive liver to relieve the wind syndrome, eliminating phlegm for resuscitation is adjuvant drug.Radix Puerariae is supervised the warm-dryness syndrome of Radix Ginseng Rubra, again can sending up the lucid YANG, and the effect with Flos Chrysanthemi, Concha Haliotidis are played ascending the clear and descending the turbid altogether is adjuvant.All medicines share, and the deficiency of vital energy can be mended, and blood stasis can loose, and wind-phlegm can be dispelled, and become benefiting QI for activating blood circulation altogether, the eliminating phlegm that relieves dizziness, high fever, infantile convulsions, epilepsy, etc., disperse blood stasis and dredge collateral, the merit for the treatment of both the principal and secondary aspects of a disease.
Above-mentioned composition can be used as the prescription of institute of traditional Chinese medicine's treatment apoplexy, and patients is fried in shallow oil soup and taken; Be more suitable for modern pharmaceutical enterprise and extract its effective ingredient, make any dosage form on the pharmaceuticss such as capsule, granule, oral liquid, concrete production method is as follows:
1, the production method of capsule:
(1) 1/2～4/5 mixing of getting Radix Ginseng Rubra, Radix Notoginseng total amount is pulverized, and crosses 80 mesh sieves, with 110-120 ℃ of hot pressing steam sterilization 10-30 minute, gets intermediate products A;
(2) get remaining Radix Ginseng Rubra, Radix Notoginseng and whole Folium Ginkgo, Radix Salviae Miltiorrhizaes, with the alcohol reflux twice of volume by volume concentration 55-70%, each 2-3 hour, extracting solution reclaimed ethanol and gets alcohol extraction part B;
(3) medicinal residues after the above-mentioned alcohol extraction are added 5-8 times of water gaging with Radix Angelicae Sinensis, Caulis Spatholobi, Rhizoma Acori Graminei, Flos Carthami, Flos Chrysanthemi, Concha Haliotidis, Radix Polygoni Multiflori, Radix Puerariae, Fructus Crataegi and decoct twice, each 2-3 hour, get water and put forward portion C;
(4) B and C mixing are concentrated, get relative density 1.05-1.20/55-60 ℃ fluid extract, spray drying gets intermediate products dried cream powder D;
(5) get intermediate products A and D and appropriate amount of auxiliary materials mixing, granulate, encapsulated, In Aluminium Foil Packing, packing gets the finished capsule product agent.
2, granule production method:
(1) get whole Radix Ginseng Rubra, Radix Notoginseng, Folium Ginkgo, Radix Salviae Miltiorrhizae, with the alcohol reflux twice of volume by volume concentration 55-70%, each 2-3 hour, extracting solution reclaimed ethanol and gets alcohol extraction part B
1
(2) medicinal residues after the above-mentioned alcohol extraction are added 5-8 times of water gaging with Radix Angelicae Sinensis, Caulis Spatholobi, Rhizoma Acori Graminei, Flos Carthami, Flos Chrysanthemi, Concha Haliotidis, Radix Polygoni Multiflori, Radix Puerariae, Fructus Crataegi and decoct twice, each 2-3 hour, get water and put forward portion C
1
(3) with B
1And C
1Mix concentrating, get relative density 1.05-1.20/55-60 ℃ intermediate products fluid extract D
1
(4) get intermediate products D
1With the appropriate amount of auxiliary materials mixing, granulate, drying, packing gets the finished particle agent.
3, oral liquid production method:
(1) get whole Radix Ginseng Rubra, Radix Notoginseng, Folium Ginkgo, Radix Salviae Miltiorrhizae, with the alcohol reflux twice of volume by volume concentration 55-70%, each 2-3 hour, extracting solution reclaimed ethanol and gets alcohol extraction part B
2
(2) medicinal residues after the above-mentioned alcohol extraction are added 5-8 times of water gaging with Radix Angelicae Sinensis, Caulis Spatholobi, Rhizoma Acori Graminei, Flos Carthami, Flos Chrysanthemi, Concha Haliotidis, Radix Polygoni Multiflori, Radix Puerariae, Fructus Crataegi and decoct twice, each 2-3 hour, get water and put forward portion C
2
(3) with B
2And C
2Mix concentrating, get relative density 1.05-1.20/55-60 ℃ intermediate products fluid extract D
2
(4) get intermediate products D
2, add an amount of syrup or Mel mixing, sterilization, fill, sterilization again gets the finished product oral liquid.
4, tablet manufacturing method:
(1) get whole Radix Ginseng Rubra, Radix Notoginseng, Folium Ginkgo, Radix Salviae Miltiorrhizae, with the alcohol reflux twice of volume by volume concentration 48-70%, each 2-3 hour, extracting solution reclaimed ethanol and gets alcohol extraction part B
3
(2) medicinal residues after the above-mentioned alcohol extraction are added 5-8 times of water gaging with Radix Angelicae Sinensis, Caulis Spatholobi, Rhizoma Acori Graminei, Flos Carthami, Flos Chrysanthemi, Concha Haliotidis, Radix Polygoni Multiflori, Radix Puerariae, Fructus Crataegi and decoct twice, each 2-3 hour, get water and put forward portion C
3
(3) with B
3And C
3Mix concentrating, get relative density 1.05-1.20/55-60 ℃ intermediate products fluid extract D
3
(4) get intermediate products D
3With the appropriate amount of auxiliary materials mixing, granulate, tabletting, packing gets finished tablet.
Instructions of taking:
Capsule, every day three times, each 2, every 0.5 gram; Granule, every day three times, each 1 bag, every bag 7 gram; Oral liquid, every day three times, each 10ml; Tablet, every day three times, each 2～3, every 0.3 gram.
The present invention compared with the prior art, its outstanding substantive distinguishing features and obvious improvement is:
1, the present invention's preferred above-mentioned Chinese medicine under Chinese medical theory instructs, science compatibility, making in addition, make that each medicine cooperatively interacts, learns from other's strong points to offset one's weaknesses, synergism, all medicines share, the deficiency of vital energy can be mended, and blood stasis can loose, and wind-phlegm can be dispelled, suppressing the hyperactive liver and subsiding YANG is played benefiting QI for activating blood circulation, the effect of the eliminating phlegm that relieves dizziness, high fever, infantile convulsions, epilepsy, etc., disperse blood stasis and dredge collateral, treating both the principal and secondary aspects of a disease altogether.
2, through clinical verification, the present invention can suppress, eliminate atherosclerosis, suppresses hypercholesterolemia and hyperlipidemia, the promoting blood circulation thrombus dissolving, the infractionization that disappears high blood viscosity, anti-platelet aggregation is unusual, antihypertensive can improve the cerebrovascular metabolic function, the resisting cerebrovascular sclerosis, it is capable to improve blood, and activating brain cell and brain function can be used for premonitory apoplexy, apoplexy sequela, the thoracic obstruction, also can be used for coronary heart disease, angina pectoris, high blood viscosity, hyperlipemia etc., treat the disease spectrum width, with strong points, evident in efficacy.
3, from the angle analysis of modern medicine, the present invention has the pathological changes that alleviates ischemic rat brain, reduces the permeability of cerebral tissue blood capillary and the water content of cerebral tissue, anticoagulant and thrombosis, cerebral blood flow increasing amount and oxygen-supplying amount, functions such as blood lipid reducing, blood sugar concentration.
4, raw material is easy to get, the prescription science, and production technology advanced person, workable, moderate product price is fit to suitability for industrialized production.
5, produce in according to each flavor Effective Components of Chinese Herb character and preparation requirement, adopt or alcohol extraction, or water carries, or the production technology of pulverizing and corresponding sterilizing methods, thereby product active constituent content height, and not perishable long shelf-life.
6, the result of product studies on acute toxicity of the present invention and long term toxicity research shows, is safe by intending with using the daily dose and the course of treatment product of the present invention.
Below be embodiments of the invention:
Embodiment one
(unit: g): Radix Ginseng Rubra 6 Radix Notoginseng 9.0 Radix Angelicae Sinensis 5.5 Caulis Spatholobis 7.8 Radix Salviae Miltiorrhizaes 8.5 Flos Carthamis 5.5 Folium Ginkgos 9.0 Fructus Crataegis 7.8 Flos Chrysanthemis 6.0 Concha Haliotidis 5.9 Radix Polygoni Multiflori 7.5 Rhizoma Acori Graminei 5.1 Radix Puerariaes 7.6 its production stages are: 1, get Radix Ginseng Rubra 4g to take by weighing following Chinese medicine ingredients, Radix Notoginseng 6g, pulverize, cross 80 mesh sieves, sterilize intermediate products A; 2, remaining Radix Ginseng Rubra 2g, Radix Notoginseng 3g and Folium Ginkgo 9.0g, Radix Salviae Miltiorrhizae 8.5g were with 4 times of amount alcohol reflux of 70% 2 hours, and alcohol extract reclaims ethanol and gets intermediate products B; 3, the medicinal residues of alcohol extraction part add twice of 5 times of water gagings extraction with nine flavor medical materials such as Radix Angelicae Sinensis 5.5g, Caulis Spatholobi 7.8g, Flos Carthami 5.5g, Fructus Crataegi 7.8g, Flos Chrysanthemi 6.0g, Concha Haliotidis 5.9g, Radix Polygoni Multiflori 7.5g, Rhizoma Acori Graminei 5.1g, Radix Puerariae 7.6g, each 2 hours, get extracting solution, partially mixed with B, concentrate, get fluid extract, spray drying gets the dried cream C of intermediate products; 4, get intermediate products A, C, mixing granulation is used capsule subpackage, and the reuse In Aluminium Foil Packing gets finished product, and name of product is " the safe capsule of three gold medal brain arteries and veins ".
Embodiment two: take by weighing following Chinese medicine ingredients: (unit: g) Radix Ginseng Rubra 8 Radix Notoginseng 10 Radix Angelicae Sinensis 6 Caulis Spatholobis 8.2 Radix Salviae Miltiorrhizaes 9.2 Flos Carthamis 5.8 Folium Ginkgos 9.5 Fructus Crataegis 8.1 Flos Chrysanthemis 6.6 Concha Haliotidis 6.6 Radix Polygoni Multiflori 8.0 Rhizoma Acori Graminei 5.5 Radix Puerariaes 7.9 its technological process of productions are: 1, get whole Radix Ginseng Rubra 8g, Radix Notoginseng 10g and Folium Ginkgo 9.5g, Radix Salviae Miltiorrhizae 9.2g was with 4.5 times of amount alcohol reflux of 60% 2 hours, and alcohol extract reclaims ethanol and gets intermediate products B
12, the medicinal residues of alcohol extraction part add twice of 8 times of water gagings extraction with nine flavor medical materials such as Radix Angelicae Sinensis 6g, Caulis Spatholobi 8.2g, Flos Carthami 5.8g, Fructus Crataegi 8.1g, Flos Chrysanthemi 6.6g, Concha Haliotidis 6.6g, Radix Polygoni Multiflori 8.0g, Rhizoma Acori Graminei 5.5g, Radix Puerariae 7.9g, each 2 hours, get extracting solution, partially mixed with B, concentrate, relative density is 1.05～1.20/55-60 ℃ fluid extract C
13, get intermediate products fluid extract C
1, with appropriate amount of auxiliary materials mixing granulation, packing, pack finished product, name of product is " three gold medal brain arteries and veins safe granule ".
Embodiment three: take by weighing following Chinese medicine ingredients: (unit: g) Radix Ginseng Rubra 10 Radix Notoginseng 8 Radix Angelicae Sinensis 7 Caulis Spatholobis 8.5 Radix Salviae Miltiorrhizaes 10.2 Flos Carthamis 6.5 Folium Ginkgos 10 Fructus Crataegis 8.2 Flos Chrysanthemis 6.5 Concha Haliotidis 6.2 Radix Polygoni Multiflori 8.5 Rhizoma Acori Graminei 5.3 Radix Puerariaes 8.3 its technological process of productions are: 1, get whole Radix Ginseng Rubra 10g, Radix Notoginseng 8g and Folium Ginkgo 10g, Radix Salviae Miltiorrhizae 10.2g was with 7 times of amount alcohol reflux of 50% 2～3 hours, and alcohol extract reclaims ethanol and gets intermediate products B
22, the medicinal residues of alcohol extraction part add twice of 8 times of water gagings extraction with nine flavor medical materials such as Radix Angelicae Sinensis 7g, Caulis Spatholobi 8.5g, Flos Carthami 6.5g, Fructus Crataegi 8.2g, Flos Chrysanthemi 6.5g, Concha Haliotidis 6.2g, Radix Polygoni Multiflori 8.5g, Rhizoma Acori Graminei 5.3g, Radix Puerariae 8.3g, each 2 hours, get extracting solution, partially mixed with B, concentrate, relative density is 1.05～1.20/55-60 ℃ fluid extract C
23, get intermediate products fluid extract C
2, add an amount of syrup or Mel mixing, sterilization, packing, sterilization again, pack finished product, name of product be " three gold medal brain arteries and veins Thailand oral liquid ".
Embodiment four takes by weighing following Chinese medicine ingredients, and (unit: g): Radix Ginseng Rubra 8.0 Radix Notoginseng 9.0 Radix Angelicae Sinensis 5.8 Caulis Spatholobis 8.0 Radix Salviae Miltiorrhizaes 8.8 Flos Carthamis 5.6 Folium Ginkgos 9.2 Fructus Crataegis 8.1 Flos Chrysanthemis 6.2 Concha Haliotidis 6.3 Radix Polygoni Multiflori 7.8 Rhizoma Acori Graminei 5.5 Radix Puerariaes 7.8 its technological process of productions are: 1, get Radix Ginseng Rubra 5g, Radix Notoginseng 5g, pulverize, cross 80 mesh sieves, sterilize intermediate products A
32, remaining Radix Ginseng Rubra 3g, Radix Notoginseng 4g and Folium Ginkgo 9.2g, Radix Salviae Miltiorrhizae 8.8g were with 5 times of amount alcohol reflux of 70% 2～3 hours, and alcohol extract reclaims ethanol and gets intermediate products B
33, the medicinal residues of alcohol extraction part add twice of 5 times of water gagings extraction with nine flavor medical materials such as Radix Angelicae Sinensis 5.8g, Caulis Spatholobi 8.0g, Flos Carthami 5.6g, Fructus Crataegi 8.1g, Flos Chrysanthemi 6.2g, Concha Haliotidis 6.3g, Radix Polygoni Multiflori 7.8g, Rhizoma Acori Graminei 5.5g, Radix Puerariae 7.8g, each 2 hours, get extracting solution, partially mixed with B, concentrate, get fluid extract, spray drying gets the dried cream C of intermediate products
34, get intermediate products A
3, C
3, mixing granulation, tabletting, packing gets finished product, and name of product is " the safe sheet of three gold medal brain arteries and veins ".
Below be clinical research report of the present invention:
Medicine of the present invention entrusts provincial, and municipal level three tame hospitals to carry out clinical verification, and job step and experimental result are as follows:
Clinical data:
One, physical data:
Apoplexy 160 examples all meet the apoplexy diagnostic criteria, and disease cycle is in 2 weeks, and Chinese medical discrimination belongs to the acute stage Ischemic Apoplexy Patients of apoplex involving the channels and collaterals syndrome of blood stasis due to qi deficiency or wind-phlegm syndrome of blood stasis.Wherein 100 examples are organized in treatment, male's 68 examples, and women's 32 examples, age 48-70 one full year of life,, 62.16 ± 7.33 years old mean age (X ± SD).Matched group 60 examples, male's 38 examples, women's 22 examples, age 45-70 year, average 59.31 ± 7.96 years old.Two groups of sexes, age distribution all do not have significant difference (P＞0.05).
(include the object of observation totally 61 examples in, wherein 1 example is dead midway because of cerebral hemorrhage, and rejecting the actual object of observation of including in back is 60 examples for the thoracic obstruction 60 examples, be and have thoracic obstruction main symptom, Chinese medical discrimination belongs to syndrome of blood stasis due to qi deficiency, and Western medicine diagnose meets the angina pectoris standard, and patient more than 2 times shows effect weekly.Wherein 30 examples are organized in treatment, male's 11 examples, and women's 19 examples, the age is in 40-70 year, average 63.39 ± 6.73 years old (X ± SD).Matched group 30 examples, male's 16 examples, women's 14 examples, age 40-70 year, average 58.73 ± 8.84 years old (X ± SD).Two groups of sexes, age distribution all do not have significant difference (P＞0.05).
Two, diagnostic criteria
1, apoplexy:
(1) primary symptom: hemiplegia, crooked mouth and tongue, mind unconsciousness, stiff tongue and retardation in speech or in silence, hemianesthesia.
(2) Acute onset.
(3) sick sending out has inducement more, and premonitory symptom is often arranged before not sending out.
(4) how send out the age well more than 40 years old.
Blood stasis due to qi deficiency pattern of syndrome or wind-phlegm blood stasis, numbness resistance venation pattern of syndrome patient are the object of observation in the selection apoplexy apoplex involving the channels and collaterals.
Blood stasis due to qi deficiency pattern of syndrome standard is: hemiplegia, and crooked mouth and tongue, speech is not smoothgoing in silence puckery, hemianesthesia, pale complexion, shortness of breath and fatigue, mouthful sialorrhea, from sweating, cardiopalmus loose stool, dimly pale tongue, thin white fur of tongue or white greasy, deep-thready pulse, slow or thin string carefully.
Wind-phlegm blood stasis, numbness resistance venation pattern of syndrome standard is: hemiplegia, facial hemiparalysis, stiff tongue and retardation in speech or in silence, hemianesthesia, have a dizzy spell dimly pale tongue, thin white fur of tongue or white greasy.
2. the thoracic obstruction:
(1) suffocating pain over the chest, very then chest pain radiating to the back;
(2) the lighter only becomes chest distress, hypopnea;
(3) Electrocardioscopy has the ischemic change or the exercise test positive.
The syndrome of blood stasis due to qi deficiency patient is the object of observation in the selection thoracic obstruction.Its pattern of syndrome standard is: feeling of oppression and pain in the chest, breathe hard, cardiopalmus, dizzy, dark tongue quality or ecchymosis is arranged, deep and stringy pulse or heavy thin.
Observational technique
Observe 220 examples altogether, be divided into 2 groups at random.Wherein 100 examples are organized in paralytic's treatment, matched group 60 examples.Thoracic obstruction patient treatment group 30 examples, matched group 30 examples.The treatment group each 2, every day 3 times, serve on for 4 weeks with medicine of the present invention " three gold medal brain arteries and veins Thailands " capsule.The matched group Ginkgo oral liquid (Hebei province * * production of city pharmaceutical factory), each 10ml, serve on for 4 weeks at every day 3 times.Conventional before the test patient is made detailed physical examination, with relevant physico-chemical examination, as electrocardiogram, blood fat, hemorheology, waist wear, CT scan etc.Change of illness state is kept a close eye in the test back, makes pathography weekly 1 time, as finding that the state of an illness obviously worsens, should stop test immediately and take other integrative therapy measures.Therapeutic effect is evaluated with scoring method.The curative effect judgement is directly made by the observer.Viewing duration is withdrawn the Chinese and western drugs that influences apoplexy and coronary heart disease curative effect in principle.Heavier to the state of an illness, withdraw the other drug person of having any problem, can be with the Western medicine application limitations at citicoline (paralytic) and nitroglycerin (thoracic obstruction patient), other Chinese medicines and Chinese patent medicine are withdrawn without exception.Finish the relevant physico-chemical examination of back check the course of treatment.
Three, therapeutic outcome:
1. to the influence of various symptoms, sign: see Table 1.From table, can find out behind two kinds of treatment for diseases groups and the matched group patient treatment the various witness integrations equal highly significant that descends, illustrate that two kinds of medicines all have therapeutical effect to the apoplexy and the thoracic obstruction, treatment back paralytic's mind, language, motor function and the thoracic obstruction are patient's feeling of oppression and pain in the chest, and symptoms such as shortness of breath and palpitation, sign all have clear improvement.
2. two kinds of medicines compare onset time apoplexy, thoracic obstruction patient: see Table 1.Can see that from table treatment group paralytic is that 2.58 ± 0.99 (X ± SD), obviously faster than matched group (30.5 ± 1.29 week), two groups of differences have significance (P＜0.05) onset time.Treatment group thoracic obstruction person is that 2.61 ± 1.13 weeks, (X ± SD) was slower than matched group (2.48 ± 1.21, two groups of difference and significance (P＞0.05) slightly onset time.
Before and after the paralytic's physico-chemical examination treatment relatively: see Table 2, table 3.From table, can find out, two groups of patient treatment after-contraction pressures, diastolic pressure, ch and TG all have obvious decline (P＜0.05), and HDL increases nonsignificance (P＞0.05).Treatment group hemorheology improves obviously (P＜0.01).
4. treatment group and matched group curative effect compare: 100 examples are organized in paralytic's treatment, and total effective rate is 89%, matched group 60 examples, and total effective rate is 76.7%, treatment group curative effect obviously is better than matched group (P＜0.01), sees Table 4.Thoracic obstruction patient treatment group 30 examples, its curative effect to treat angina pectoris, ECG curative effect, clinical card marquis curative effect total effective rate are respectively 90.0%, 60.0%, 83.4%.Matched group 30 examples, very main angor curative effect, ECG curative effect, clinical card marquis curative effect total effective rate is respectively 93.3%, 63.3%, 93.3%.Two groups of relatively more equal nonsignificances (P＞0.05) of curative effect see Table 5.
Side effect
Two groups of patients all do not find obvious adverse reaction and toxic and side effects at viewing duration.
Model case
Example 1, congratulate * *, man, 56 years old, (medical record number: 64463).
The patient is admitted to hospital in emergency treatment on May 8 in 1994 because of " the companion's speech of falling forward dusk suddenly is unfavorable, left limb moving obstacle half a day ".Conscious having a dizzy spell, palpitation and night sweat, hemianesthesia.Inspection is seen: refreshing clear, crooked mouth and tongue sialorrhea, and language performance is owed entirely, lifts on the left shoulder joint and can not put down shoulder, and articulations digitorum manus only can be clenched fist, and left side leftover bits and pieces hip joint still can stretch in the wrong but a little less than the power, toe joint is stretched Qu Buquan, dark tongue quality, white and greasy fur, deep-thready pulse.Diagnose through CT examination: right side temporal lobe cerebral infarction, tcm diagnosis: apoplexy (apoplex involving the channels and collaterals one wind-phlegm blood stasis type).With medicine of the present invention " the safe capsule of three gold medal brain arteries and veins " treatment, every day three times, each 2.Take medicine only two weeks, hemiplegia, having a dizzy spell begins to alleviate, and shoulder joint has gone up lifts flat shoulder, and life can partial self-help.After all around, former symptom disappears substantially, and patient's life can be taken care of oneself, and June 9, recovery from illness was left hospital.
Example 2, open * *, woman, 50 years old, (medical record number: 64173).
The patient is admitted to hospital on May 17th, 1994 because of " pain uncomfortable in chest, hypopnea 1 hour ", conscious pain uncomfortable in chest, shortness of breath and fatigue, cardiopalmus, has a dizzy spell.Inspection sees that lustreless complexion, tiredness with no desire to speak, dark tongue quality have speckle, white and thin fur, deep-thready pulse.Electrocardioscopy is shown: T1,11, a VL, V3-6 hang down flat.Tcm diagnosis: thoracic obstruction Qi deficiency blood stasis type), Western medicine diagnose: angina pectoris.Treat, day obey each 23 times with medicine of the present invention " the safe capsule of three gold medal brain arteries and veins ".After, sensation of oppression over the chest with shortness of breath, the weak beginning of cardiopalmus alleviate, and are kept to 1 time for 2 times the every day of feeling of oppression and pain in the chest when being admitted to hospital, time, pain degree obviously alleviated by being kept to 10 minutes half an hour, around the after, pain uncomfortable in chest is not reaccessed, only surplus slightly breathing hard and dizzy symptom, and surplus disease disappears.Check electrocardiogram: normal ECG roughly.Curative effect to treat angina pectoris, ECG curative effect and clinical card marquis efficacy evaluation are produce effects.
Relatively (two groups of X ± SD) and onset times are relatively for the witness integration before and after table 1 treatment
| Treatment group matched group | |
| After treating before the preceding treatment of the n treatment back n treatment | |
| Apoplexy A organizes total mark | 100 13.63±4.68 6.77±4.23 60 11.05±4.24 6.75±4.05** |
| B organizes total mark | 100 13.69±4.37 6.09±3.99** 60 11.17±3.63 6.31±3.46** |
| Onset time (week) * | 100 2.58＝0.99 60 3.05±1.29 |
| Thoracic obstruction total mark | 30 11.58＝2.81 4.17±3.09** 30 3.96±3.46 4.63±3.00** |
| Onset time (week) | 30 2.61＝1.13 30 2.48±1.21 |
Annotate: before and after the treatment relatively or two groups relatively, * P＜0.05, * * P＜0.01 (as follows)
Compare before and after the table 2 paralytic physico-chemical examination treatment (X ± SD)
| After treating before treatment group (n=100) treatment | After treating before matched group (n=100) treatment | |
| Systolic pressure (KPa) | 19.81±3.21 17.86±2.43** | 19.30±3.20 17.93±1.99*** |
| Diastolic pressure (KPa) | 12.29±2.00 10.91±1.19** | 11.23±1.74 10.53±1.23** |
| ch(mmol/l) | 5.60±1.27 5.19±1.10** | 5.80±1.04 5.55±0.79** |
| HDL(mmol/l) | 14.66±21.37 15.60±22.91 | 22.56±22.98 22.90±23.11 |
| TG(mmol/l) | 1.91±1.10 1.61±0.78** | 2.09±1.10 1.90±0.97* |
Compare (Ridit analysis) before and after the treatment of table 3 paralytic blood examination
| Normally+++ +++++ ++++++R u p ++ ++ +++ | |
| The treatment group | Treat preceding 4 14 18 17 16 22 9 0.444 2.766＜0.01 treatment back 12 17 13 30 14 14 0 0.557 |
| Matched group | Treat preceding 3636750 0.431 0.841＞0.05 treatment back 5776410 0.569 |
Annotate: one be unusually+, 2 are unusually ++ the rest may be inferred by analogy.
Table 4 treatment group and matched group curative effect be (Rikit analysis) relatively
| n | Recovery from illness | Produce effects | Effectively | Invalid | Total effective rate % | R | U | P | ||
| Apoplexy | Treatment group matched group | 100 60 | 5 0 | 53 22 | 31 26 | 11 12 | 89.0％ 76.7％ | 0.546 0.424 | 2.586 | ＜0.01 |
Table 5 thoracic obstruction treatment group and matched group curative effect be (Rikit analysis) relatively
| Classification | Grouping | The example number | Produce effects (%) | Effectively (%) | Invalid (%) | Increase the weight of (%) | Total effective rate (%) | R | U | P |
| Curative effect to treat angina pectoris | The treatment contrast | 30 30 | 15(50.0) 6(20.0) | 12(40.0) 22(73.3) | 3(10.0) 2(6.7) | 0 0 | 90.0 93.3 | 0.627 0.500 | 1.700 | ＞0.05 |
| ECG curative effect | The treatment contrast | 30 30 | 4(13.3) 5(16.7) | 14(46.7) 14(46.7) | 12(40.0) 11(36.7) | 0 0 | 60.0 63.3 | 0.475 0.500 | 0.329 | ＞0.05 |
| The symptom curative effect | The treatment contrast | 30 30 | 14(16.7) 12(40.0) | 14(36.7) 16(53.3) | 5(16.6) 2(6.7) | 0 0 | 83.4 93.3 | 0.501 0.500 | 0.015 | ＞0.05 |
Brief summary
Above clinical data discloses:
1. the safe capsule of medicine three gold medal brain arteries and veins of the present invention has the promote blood circulation effect of brain-strengthening suppressing the hyperactive liver of inrigorating qi and promoting blood circulation, dispelling pathogenic wind and eliminating phlegm, blood stasis dispelling, and cerebral infarction card, angina pectoris due to blood stasis due to qi deficiency, wind-phlegm blood stasis, the passages through which vital energy circulates impatency are had therapeutical effect.
2. the safe capsule of medicine three gold medal brain arteries and veins of the present invention has blood pressure lowering, effect for reducing blood fat, and hemorheology is also improved significantly.Prompting offsets except that symptom before the apoplexy, and reducing cerebrovascular disease has certain preventive and therapeutic effect.
3. the safe capsule for treating paralytic of medicine three gold medal brain arteries and veins of the present invention 100 examples, total effective rate is 89%, curative effect be better than Hebei province * * Ginkgo oral liquid that city pharmaceutical factory produces.The treatment thoracic obstruction 30 examples, the total effective rate of angina pectoris, electrocardiogram, symptom curative effect is for being respectively 90.0%, 60.0%, 83.4%, curative effect and ginkgo oral liquid no significant difference.
4. this product is safe and reliable, and 130 examples are not all found obvious adverse reaction and toxic and side effects at viewing duration.
Claims (6)
1, a kind of medicine for the treatment of apoplexy is characterized in that the component of its main activated feedstock and weight percentage are as follows: Radix Ginseng Rubra 6.05～15.8; Radix Notoginseng 8.95～10.08; Radix Angelicae Sinensis 5.12～8.34; Caulis Spatholobi 7.76～8.97; Radix Salviae Miltiorrhizae 8.01～11.13; Flos Carthami 5.18～8.84; Folium Ginkgo 8.87～10.11; Fructus Crataegi 7.76～8.55; Flos Chrysanthemi 5.78～6.89; Concha Haliotidis 5.80～6.53; Radix Polygoni Multiflori 7.77～8.84; Rhizoma Acori Graminei 5.03～5.74; Radix Puerariae 7.56～8.65.
2, the medicine of treatment apoplexy according to claim 1 is characterized in that said dosage form is a said dosage form on any pharmaceutics.
3, the medicine production method of the described treatment apoplexy of a kind of claim 2 is characterized in that producing by the following method capsule:
(1) 1/2～4/5 mixing of getting Radix Ginseng Rubra, Radix Notoginseng total amount is pulverized, and crosses 80 mesh sieves, with 100-120 ℃ of hot pressing steam sterilization 10-30 minute, gets intermediate products A;
(2) getting remaining Radix Ginseng Rubra, Radix Notoginseng and whole Folium Ginkgo, Radix Salviae Miltiorrhizaes, is the alcohol reflux twice of 55-70% with 3～8 times of amount volume by volume concentrations, and each 2-3 hour, extracting solution reclaimed ethanol and gets alcohol extraction part B;
(3) medicinal residues after the above-mentioned alcohol extraction are added 5-8 times of water gaging with Radix Angelicae Sinensis, Caulis Spatholobi, Rhizoma Acori Graminei, Flos Carthami, Flos Chrysanthemi, Concha Haliotidis, Radix Polygoni Multiflori, Radix Puerariae, Fructus Crataegi and decoct twice, each 2-3 hour, get water and put forward portion C;
(4) B and C mixing are concentrated, get fluid extract, spray drying gets intermediate products dried cream powder D;
(5) get intermediate products A and D and appropriate amount of auxiliary materials mixing, granulate, encapsulated, In Aluminium Foil Packing, packing gets the finished capsule product agent.
4, the medicine production method of the described treatment apoplexy of a kind of claim 2 is characterized in that producing by the following method granule:
(1) get whole Radix Ginseng Rubra, Radix Notoginseng, Folium Ginkgo, Radix Salviae Miltiorrhizae, with the alcohol reflux twice of 3～8 times of amount volume by volume concentration 55-70%, each 2-3 hour, extracting solution reclaimed ethanol and gets alcohol extraction part B
1
(2) medicinal residues after the above-mentioned alcohol extraction are added 5-8 times of water gaging with Radix Angelicae Sinensis, Caulis Spatholobi, Rhizoma Acori Graminei, Flos Carthami, Flos Chrysanthemi, Concha Haliotidis, Radix Polygoni Multiflori, Radix Puerariae, Fructus Crataegi and decoct twice, each 2-3 hour, get water and put forward portion C
1
(3) with B
1And C
1Mix concentrating, get intermediate products fluid extract D
1
(4) get intermediate products D
1With the appropriate amount of auxiliary materials mixing, granulate, drying, packing gets the finished particle agent.
5, the medicine production method of the described treatment apoplexy of a kind of claim 2 is characterized in that producing by the following method oral liquid:
(1) get whole Radix Ginseng Rubra, Radix Notoginseng, Folium Ginkgo, Radix Salviae Miltiorrhizae, with the alcohol reflux twice of volume by volume concentration 55-70%, each 2-3 hour, extracting solution reclaimed ethanol and gets alcohol extraction part B
2
(2) medicinal residues after the above-mentioned alcohol extraction are added 5-8 times of water gaging with Radix Angelicae Sinensis, Caulis Spatholobi, Rhizoma Acori Graminei, Flos Carthami, Flos Chrysanthemi, Concha Haliotidis, Radix Polygoni Multiflori, Radix Puerariae, Fructus Crataegi and decoct twice, each 2-3 hour, get water and put forward portion C
2
(3) with B
2And C
2Mix concentrating, get relative density 1.05-1.20/55-60 ℃ intermediate products fluid extract D
2
(4) get intermediate products D
2, add an amount of syrup or Mel mixing, sterilization, fill gets the finished product oral liquid.
6, the medicine production method of the described treatment apoplexy of a kind of claim 2 is characterized in that producing by the following method tablet:
(1) 1/2～4/5 mixing of getting Radix Ginseng Rubra, Radix Notoginseng total amount is pulverized, and crosses 80. mesh sieves, with 100-120 ℃ of hot pressing steam sterilization 10-30 minute, gets intermediate products A
3
(2) getting remaining Radix Ginseng Rubra, Radix Notoginseng and whole Folium Ginkgo, Radix Salviae Miltiorrhizaes, is the alcohol reflux twice of 55-70% with 3～8 times of amount volume by volume concentrations, and each 2-3 hour, extracting solution reclaimed ethanol and gets alcohol extraction part B
3
(3) medicinal residues after the above-mentioned alcohol extraction are added 5-8 times of water gaging with Radix Angelicae Sinensis, Caulis Spatholobi, Rhizoma Acori Graminei, Flos Carthami, Flos Chrysanthemi, Concha Haliotidis, Radix Polygoni Multiflori, Radix Puerariae, Fructus Crataegi and decoct twice, each 2-3 hour, get water and put forward portion C
3
(4) with B
3And C
3Mix concentrating, get fluid extract, spray drying gets intermediate products dried cream powder D
3
(5) get intermediate products A
3And D
3With the appropriate amount of auxiliary materials mixing, granulate, tabletting, packing gets finished tablet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 00131558 CN1111054C (en) | 2000-10-26 | 2000-10-26 | Medicine for treating apoplexy and its preparing process |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 00131558 CN1111054C (en) | 2000-10-26 | 2000-10-26 | Medicine for treating apoplexy and its preparing process |
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| CN1111054C true CN1111054C (en) | 2003-06-11 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 00131558 Expired - Lifetime CN1111054C (en) | 2000-10-26 | 2000-10-26 | Medicine for treating apoplexy and its preparing process |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100348223C (en) * | 2005-11-01 | 2007-11-14 | 山东省中医药研究院 | Medicine for treating ischemic cerebral disease and its prepn |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1785284B (en) * | 2004-12-10 | 2012-04-18 | 天津天士力制药股份有限公司 | Medicinal composition containing flowery knotwood root |
| CN102805824B (en) * | 2012-08-25 | 2013-10-30 | 兰恒志 | Drug for curing apoplexy and preparation method thereof |
| CN102961669A (en) * | 2012-11-28 | 2013-03-13 | 西安泰科迈医药科技有限公司 | Pure traditional Chinese medicine compound preparation for treating cerebral infarction and preparation method thereof |
| CN109865080A (en) * | 2019-04-19 | 2019-06-11 | 刘永钦 | It is a kind of for treating the Chinese medicine preparation of multiple cerebral |
-
2000
- 2000-10-26 CN CN 00131558 patent/CN1111054C/en not_active Expired - Lifetime
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100348223C (en) * | 2005-11-01 | 2007-11-14 | 山东省中医药研究院 | Medicine for treating ischemic cerebral disease and its prepn |
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| Publication number | Publication date |
|---|---|
| CN1293971A (en) | 2001-05-09 |
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