CN1965966A - Chinese medicinal composition for treating cardiovascular and cerebrovascular diseases, preparation method and application thereof - Google Patents
Chinese medicinal composition for treating cardiovascular and cerebrovascular diseases, preparation method and application thereof Download PDFInfo
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Abstract
The invention provides a Chinese medicinal composition for treating cardiovascular and cerebrovascular diseases which comprises the following raw material herbs (by weight portions): astragalus root 480-660, radix salvia miltiorrhiza 60-160, red peony root 60-160, rhizome of Sichuan lovage 60-160, Chinese angelica root 60-160, safflower 60-160, leech 40-90, ground beetle 40-90, peach kernel 60-160, artificial ox gallstone 10-40, antelope's horn 10-40, buthus martensi kirsch 50-140, polygala root 60-160, acorus gramineus soland 60-160 and medicinal adjuvant. The invention also provides the method for preparation and use of the composition.
Description
Technical field
The invention belongs to Chinese medicine preparation, particularly relate to and a kind ofly be used for the treatment of Qi deficiency blood stasis type or have the obstruction of collateral caused by windphlegm type concurrently or have ischemic Chinese medicine composition that is used for the treatment of cerebrovascular of stirring of wind due to deficiency of YIN type and preparation method thereof and application concurrently.
Background technology
Cerebrovascular is to cause one of three human dead big diseases, is common nervous system disease, and the traditional Chinese medical science says and be apoplexy, wherein sickness rate reach 80% be ischemic cerebrovascular, and can cause serious deformity.The data of announcing according to world's department of neurology conference in 1997 shows, whole world apoplexy sickness rate, case fatality rate and disability rate are still high, sickness rate shows as tangible regional difference, the age standardized rate is male 101～2,85/,100,000, women 47～1,98/,100,000, sickness rate increases with the age and significantly rises.Disability rate is in Britain, and 24% handicap is caused by apoplexy, and existing millions of apoplexy survivors, and 80% above apoplexy are to be caused by cerebral ischemia, and its survival rate is significantly higher than other type person.Among the survivor, have only 10% can recover normal function fully, 48% patient loses hemiplegia, and 22% patient can't walk, and 24%～53% patient can't take care of oneself wholly or in part.Updated statistics shows, in the world, cerebrovascular makes 4,600,000 people's death every year, wherein 2/3 occur in developing country, ill and dead mainly the crowd of over-65s, China is cerebrovascular disease mortality rate hotspot, the resident now suffers from cerebrovascular 6,000,000 according to estimates, annual kainogenesis cerebrovascular 1,300,000 people, dead nearly 1,000,000 people, about 3/4 people stays symptoms such as hemiplegia in survivor, part patient's disability and viability.
Cerebrovascular disease has become the commonly encountered diseases of serious threat people ' s health, frequently-occurring disease.China is as the country that enters aging society rapidly, coastal opening especially, and the developed area, many people are because of the overstrain internal injury, and it is angry to be worried, and has a liking for inducements such as food savoury, is that this sick sickness rate is higher, near the upper limit of above-mentioned age standardized rate.Realistic situation shows that present medicine can not meet clinical needs.Therefore, prevent and treat apoplexy, especially promote to recover, reduce disability rate and become the task of top priority.
The tradition traditional Chinese medical science thinks, apoplexy is because of many complicated, but in numerous factors, because of void causes the stasis of blood, and blood stagnant in cerebral venation syndrome, the main cause that develops for the generation of decision apoplexy, and through the whole morbidity stage.From ancient times to the present, each is cured house and thinks that all apoplexy is relevant with " void ", as " in the interior exogenous pathogen " before the Tang and Song Dynasty, and it " kidney water void declines " of golden Liu Wansu opinion; Bright Zhang Jiebin emphasizes " internal injury is long-pending decreases "; Clear leaf sky scholar thinks due to " the essence and blood consumption declines, and the kidney failing to nourish the liver, liver-yang are high partially, rise during endogenous wind ".Clear Wang Qingren is seted forth one's views with the deficiency of vital energy, " the vigour loss is its origin ".Now, then it being reduced void, fire, wind, expectorant, gas, blood six ends, is that it is basic with the hepatic and renal YIN deficiency." void be apoplexy root also, only apoplexy is because empty " (" miscellaneous diseases source and course rhinoceros candle apoplexy ").
Yet independent " void " still is not enough to cause apoplexy, has only the void because of Liver and kidney, the void of QI and blood, the biochemistry of influence essence, gas, blood and operation and the hyperamization stasis of blood, stagnation of blood stasis brain network, or liver-wind, the turbid numbness resistance of expectorant brain key, ability apoplexy.Cause the body imbalance of YIN and YANG, QI and blood is disorderly contrary." a Ling Shu Miraculous Pivot or Divine Axis Benshen piece of writing " said: " people's blood qi essence and spirit person, thus Feng Sheng and the week in life person also ".Shen Jin Ao more spells out in " the Chen Shi honor is given birth to book ": " fate blood, principal is circulated with gas, airsetting blood also coagulates also ".Wang Qingren is pointed out in errors in Medicine Corrected: " gist of curing the disease is to understand QI and blood ".The treatment cerebral infarction, this is basic must to catch QI and blood all the time.
The BUYANG HUANWU TANG of usefulness inrigorating qi and promoting blood circulation collateral dredging such as Zhu Ruifen is main, treatment cerebral infarction 156 examples.Matched group 30 examples are peaceful with eliminating thrombus and removing obstruction in channels.Level before and after this group treatment is stared function, facial paralysis, speech, muscular strength, walking ability as a result, dizzy and cardiopalmus integration more all has significant difference P＜0.01.
Zhao Li etc. adopt activating blood and removing stasis Method, intend alkene certainly and sign TONGSHUAN WAN treatment cerebral thrombosis 70 examples, total effective rate 98.1%, observed result proves that this medical instrument has the circulation of improvement, anticoagulant and anti-blood viscosity, antiplatelet aggregative activity, disclose this product and use blood circulation promoting and blood stasis dispelling, can reduce disability rate.
Xiao Jianrong is from intending stroke rehabilitation soup, among the inrigorating qi and promoting blood circulation collateral dredging, add the product of having one's ideas straightened out with relieving dizziness, high fever, infantile convulsions, epilepsy, etc., select Radix Astragali 30g, Rhizoma Chuanxiong, Radix Angelicae Sinensis, each 10g of Pheretima, Flos Carthami 5g, Radix Paeoniae Rubra 15g, Hirudo 6g, Scorpio 10g, Rhizoma Acori Graminei 15g for use, 1 dose of day, be decocted in water for oral dose, course of treatment on the 15th, the contrast medicine is selected FUFANG DANSHEN ZHUSHEYE 20ml+10% glucose 500ml intravenous drip for use.As a result, two groups of 26,16 examples that are almost recovered respectively; Produce effects 6,3 examples; Effective 3,6 examples; Invalid 1,5 examples, total effective rate 97.2%, 83.3%, the whole blood height cut viscosity, plasma viscosity, Fibrinogen, packed cell volume, T-CHOL, triglyceride, and two groups of treatments of HDL-ch before and after between self and treatment back group relatively, significant difference P＜0.01,0.05 is all arranged.
The BUYANG HUANWU TANG of the well-known doctor of Qing Dynasty Wang Qingren mainly by the Qi-tonifying drug Radix Astragali, reaches compositions such as Radix Angelicae Sinensis, Radix Paeoniae Rubra, Pheretima for the classic prescriptions of treatment apoplexy sequela, method of treatment is based on QI invigorating, hold concurrently with promoting blood circulation to remove obstruction in the collateral, empty for being lost by healthy energy, the symptom of the various apoplexies due to the obstruction of collaterals by blood stasis can convalesce.
In recent years, the traditional Chinese medical science is obtaining considerable progress to the research of primary disease aspect etiology and pathogenesis, diagnosis and treatment rule, medicine and the zoopery.Aspect drug research, for ischemic cerebrovascular, according to present clinical patients characteristics of incidence, especially convalescent treatment, many according to the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs under motherland's medical science organic conception, adopt the inrigorating qi and promoting blood circulation collateral dredging, it is in the majority with the waking up the patient from unconsciousness by dissipating phlegm method that relieves dizziness, high fever, infantile convulsions, epilepsy, etc. to hold concurrently.Existing Chinese patent medicine is to the treatment of ischemic cerebrovascular, or blood circulation promoting and blood stasis dispelling, or relieving spasm by subduing liver-wind, or inrigorating qi and promoting blood circulation or the like, treatment is respectively laid particular stress on, but part not fully up to expectations is all arranged.On the clinical application method, mostly clinical is the usage that adopts decoction, causes the liposoluble constituent of flavour of a drug, volatile ingredient to lose seriously, has influenced the clinical efficacy of compound recipe.
Summary of the invention
The object of the invention is to provide a kind of Chinese medicine composition that is used for the treatment of cerebrovascular and preparation method thereof and application, said composition is clinical prevention and treats ischemic cerebrovascular and adapt to symptom Chinese medicine composition more widely, this preparation method has overcome the drawback of conventional dosage forms such as decoction, clinical symptoms in the hope of the patient that improves each phase of ischemic cerebrovascular is beneficial to improve people's health quality.
For achieving the above object, the technical solution used in the present invention provides a kind of Chinese medicine composition that is used for the treatment of cerebrovascular, wherein: constitute by following flavour of a drug by weight:
The Radix Astragali 480～660, Radix Salviae Miltiorrhizae 60～160, Radix Paeoniae Rubra 60～160, Rhizoma Chuanxiong 60～160, Radix Angelicae Sinensis 60～160, Flos Carthami 60～160, Hirudo 40～90, Eupolyphaga Seu Steleophaga 40～90, Semen Persicae 60～160, artificial Calculus Bovis 10～40, Cornu Saigae Tataricae 10～40, Scorpio 50～140, Radix Polygalae 60～160, Rhizoma Acori Graminei 60～160 also have pharmaceutic adjuvant.
A kind of preparation method that is used for the treatment of the Chinese medicine composition of cerebrovascular is provided, overcome the drawback of conventional dosage forms such as decoction, the method that adopts alcohol extraction and volatile oil to extract, the liposoluble constituent and the volatilization wet goods effective ingredient that have clinical efficacy in the compositions have been kept, adopt high-efficiency dynamic circulation extraction equipment, extract effective ingredient to greatest extent, guaranteed its clinical efficacy.
Clinical practice with above-mentioned traditional Chinese medicine composition for treating ischemic cerebrovascular (cerebral infarction) is provided simultaneously.
Effect of the present invention is: this Chinese medicine composition obviously is better than similar medicine to the prevention of ischemic cerebrovascular with therapeutical effect.
The pharmacodynamics experimentation has disclosed the mechanism of this Chinese medicine composition prevention and treatment cerebral infarction disease before clinical:
Chinese medicine composition extractum prevention administration, treatment administration are plugged with the obvious treatment effect to cerebral infarction due to the blocking-up intraluminal middle cerebral artery occlusion in rats, and cerebral infarction organizes percentage ratio obviously to reduce, and obviously improves its behavior disorder; Gastric infusion can obviously improve the behavior score of pallasiomy experimental cerebral ischemia, the rising that improves pallasiomy ischemia side cerebral hemisphere sodium content and the reduction of potassium content; Intravenous administration in the time of 1～3 minute, obviously increases anesthetized dog ICAF amount, obviously reduces cerebral vascular resistance, and blood pressure and heart rate are not had obvious influence.Duodenum gives Chinese medicine composition extractum, and above-mentioned four indices is not all had obvious influence; To hemorheological influence, this Chinese medicine composition extractum is gastric infusion repeatedly, obviously reduces whole blood viscosity, plasma viscosity, erythrocyte sedimentation rate and the hematocrit of blood stasis model rat, and increases with dosage, and effect strengthens; This Chinese medicine composition extractum is gastric infusion repeatedly, the obvious prolong rats experimental thrombosis of high, middle dosage group formation time; Obviously suppress obviously to prolong the clotting time of experiment mice by ADP, AA, collagen-induced experimental rat platelet aggregation.
Clinical efficacy is the result show, take this Chinese medicine composition after, it is to tcm syndrome hemiplegia, stiff tongue and retardation in speech, hemianesthesia, the equal tool produce effects of all index of crooked mouth and tongue; Self more all have clear improvement in body of the tongue, tongue fur, all index group of pulse condition, this Chinese medicine composition compares with matched group all single index treatments of tcm syndrome back, and treatment group total effective rate and cure-remarkable-effectiveness rate all obviously are better than matched group.Treatment back apoplexy total effective rate and cure-remarkable-effectiveness rate treatment group all are higher than matched group, treat back tcm syndrome total effective rate and cure-remarkable-effectiveness rate treatment group apparently higher than matched group.Illustrate that its clinical therapeutic efficacy of this Chinese medicine composition obviously is better than existing similar medicine.
The safety of this Chinese medicine composition and untoward reaction aspect, zoopery and clinical observation on the therapeutic effect all show, this medicine is safe and reliable, have no adverse reaction.
This Chinese medicine composition is the treatment Qi deficiency blood stasis type or has the obstruction of collateral caused by windphlegm type concurrently or have the effective of stirring of wind due to deficiency of YIN type ischemic cerebrovascular (cerebral infarction) concurrently and the innerwear Chinese medicine preparation of safety, clinical findings hemiplegia to the patient, crooked mouth and tongue, stiff tongue speech is not smoothgoing or in silence, hemianesthesia, the complexion white light is white, shortness of breath and fatigue or vertigo and tinnitus, dimly pale tongue or dark red, white and thin fur or white greasy, the symptom of deep-thready pulse or stringy and thready pulse, stringy and rolling pulse improves significantly and therapeutical effect, has reduced disability rate, has improved patient's health quality.
The specific embodiment
In conjunction with the embodiments Chinese medicine composition that is used for the treatment of cerebrovascular of the present invention and preparation method thereof and application are described in detail.
The present invention is according to traditional Chinese medical science traditional theory, two big class symptoms of analysis apoplexy (ischemic cerebrovascular): mind obstacle and obstacle of limb movement, the pathogenesis of confirming apoplexy is a deficiency in origin and excess in superficiality, clinical findings ischemic cerebrovascular (cerebral thrombosis, cerebral infarction) with the deficiency of vital energy is this, phlegm stagnation in collateral, key close god hide into the mark person in the majority, in view of the above according to the morbific characteristics of primary disease " void " " stasis of blood " " wind " " expectorant ", establish inrigorating qi and promoting blood circulation, the principle of treatment that eliminating phlegm relieves dizziness, high fever, infantile convulsions, epilepsy, etc. serves as basis side with the well-known doctor of Qing Dynasty Wang Qingren classic prescriptions " BUYANG HUANWU TANG ", add to simplify to cut out in conjunction with clinical experience and form this Chinese medicine composition, in the hope for the treatment of both the principal and secondary aspects of a disease.Compare with BUYANG HUANWU TANG, BUYANG HUANWU TANG is by Qi-tonifying drug and blood circulation and stasis-eliminating medicine is compatible forms, and treatment focuses on the morbific characteristics of " void " " stasis of blood ", the heavy QI invigorating of institute's dosage, light blood stasis dispelling.This product on the basis of " void " " stasis of blood ", is taken into account " wind " " expectorant " paathogenic factor according to present clinical common apoplexy pathogenic characteristic; with Hirudo; Eupolyphaga Seu Steleophaga, Radix Salviae Miltiorrhizae replaces Pheretima, strengthens the disperse blood stasis and dredge collateral effect; and add with artificial Calculus Bovis, Cornu Saigae Tataricae, Scorpio calming wind and dredging collateral; and with Rhizoma Acori Graminei, Radix Polygalae dissolving turbidity for resucitation, our compatibility is appropriate, adapts to wide; adapt to present clinical practice disease situation more, curative effect is reliable.
Chinese medicine composition of the present invention is made up of the Radix Astragali, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Flos Carthami, Hirudo, Eupolyphaga Seu Steleophaga, Semen Persicae, artificial Calculus Bovis, Cornu Saigae Tataricae, Scorpio, Radix Polygalae, Rhizoma Acori Graminei.
We are at inrigorating qi and promoting blood circulation, and on the disperse blood stasis and dredge collateral basis, the product that compatibility relieves dizziness, high fever, infantile convulsions, epilepsy, etc. spasmolytic and eliminates phlegm for resuscitation are at the characteristics that primary disease " void " " stasis of blood " " wind " " expectorant " is cured the disease, laying equal stress on both the incidental and fundamental.
Present primary disease clinical findings, middle-older patient is more common in its morbidity, the positive QI-insufficiency of clinical manifestation, hepatic and renal YIN deficiency.The one side insufficiency of vital energy and blood, deficiency of vital energy blood fortune is not smooth, stagnation of QI-blood, the resistance of venation numbness; Hepatic and renal YIN deficiency on the other hand, liver-yang is high partially, and sees vertigo and tinnitus; The sun wind-transformation is moving, holds expectorant under the arm and walks to scurry meridians, and venation is not smooth, causes blood stasis then, the inaccessible brain key of wind-phlegm, and cause hemiplegia, hemianesthesia; Blood stasis due to qi deficiency, phlegm stagnation in collateral, this mistake of tongue are supported, so speech is not smoothgoing puckery or in silence; It is then unfavorable through then that wind-phlegm hinders in the women's head-ornaments meridians, and muscles loses supports, so see crooked mouth and tongue, very then facial muscle are twitched.Mian Se Koushi is white; Shortness of breath and fatigue, dimly pale tongue or dark red, white and thin fur or white greasy, deep-thready pulse or stringy and thready pulse are blood stasis due to qi deficiency, liver-wind stirring up internally, phlegm-damp hinders resembling of network.In sum, we card system is owing to due to the blood stasis due to qi deficiency, the inaccessible brain key of wind-phlegm, control and work as inrigorating qi and promoting blood circulation, and eliminating phlegm relieves dizziness, high fever, infantile convulsions, epilepsy, etc.
The Radix Astragali in the Chinese medicine composition, abnormal smells from the patient is sweet, and tepor is gone into the lung spleen channel, reuses the Radix Astragali, invigorating qi and dredging collateral, blood stasis dispelling and just not hindering is as " not Lu " so-called " by stagnant blood between the five internal organs ".Give birth to but not process with it and be intended to, get its power obligate and walk, week the row whole body, the power with the moving all medicines of boosting is monarch drug.
Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra blood circulation promoting and blood stasis dispelling; Rhizoma Chuanxiong, nature and flavor are hot to loose, and blood circulation promoting competent silt is good at and is dispeled the wind, but the gas in the promoting the circulation of blood, the wind in the blood of dispelling, and draw the up head of all medicines.Zhang Yuansu claims Rhizoma Chuanxiong " the up head, the descending sea of blood, the wind of the soothing the liver warp of energy ".Chinese angelica blood supplementing is invigorated blood circulation, Flos Carthami removing blood stasis with potent drugs promoting blood circulation to restore menstrual flow, Hirudo, Eupolyphaga Seu Steleophaga removing blood stasis, Semen Persicae, bitter flat, the property of medicine is purer, join the removing blood stasis with potent drugs medicine and then focus on clots absorbing, the product that close promoting the circulation of blood then merit in promoting the circulation of blood, more than eight flavors, focus on promoting blood circulation by removing blood stasis, match with the monarch drug Radix Astragali, play inrigorating qi and promoting blood circulation, the effect of removing blood stasis collateral dredging is ministerial drug.
Artificial Calculus Bovis, Cornu Saigae Tataricae, Scorpio go into Liver Channel, belong to liver wind calming drug together, are longer than relieving spasm by subduing liver-wind, and three medicines share, suppressing the hyperactive liver to relieve the wind syndrome, and removing obstruction in the collateral to relieve pain is used to improve levying of crooked mouth and tongue.
Radix Polygalae, Rhizoma Acori Graminei are changed turbid damp eliminating, focus on and have one's ideas straightened out, and share with the artificial Calculus Bovis, have more the merit of clear heat and eliminate phlegm, the above five tastes, and relieve dizziness, high fever, infantile convulsions, epilepsy, etc. eliminating phlegm and usefulness are adjuvant drug.
Full side 14 flavors, compatibility is rigorous, cautiously grasping pathogenesis, reinforcement and elimination in combination is played inrigorating qi and promoting blood circulation altogether, the merit of the eliminating phlegm that relieves dizziness, high fever, infantile convulsions, epilepsy, etc.
This Chinese medicine composition function: inrigorating qi and promoting blood circulation, eliminating phlegm relieves dizziness, high fever, infantile convulsions, epilepsy, etc.
Cure mainly: Qi deficiency blood stasis type or have the obstruction of collateral caused by windphlegm type concurrently or have stirring of wind due to deficiency of YIN type ischemic cerebrovascular (cerebral infarction) concurrently.Disease is seen hemiplegia, crooked mouth and tongue, and stiff tongue speech is not smoothgoing or in silence, hemianesthesia, the complexion white light is white, shortness of breath and fatigue or vertigo and tinnitus or accumulation and obstruction of sputum, dimly pale tongue or dark red, white and thin fur or white greasy, deep-thready pulse or stringy and thready pulse, stringy and rolling pulse.
Chinese medicine composition of the present invention is grouped into by following one-tenth:
Constitute by following flavour of a drug by weight:
The Radix Astragali 480～660, Radix Salviae Miltiorrhizae 60～160, Radix Paeoniae Rubra 60～160, Rhizoma Chuanxiong 60～160, Radix Angelicae Sinensis 60～160, Flos Carthami 60～160, Hirudo 40～90, Eupolyphaga Seu Steleophaga 40～90, Semen Persicae 60～160, artificial Calculus Bovis 10～40, Cornu Saigae Tataricae 10～40, Scorpio 50～140, Radix Polygalae 60～160, Rhizoma Acori Graminei 60～160 also have pharmaceutic adjuvant.
The enough Radix Codonopsis of described Radix Astragali energy, Radix Ginseng, Radix Ginseng, Radix Ginseng Rubra, wild ginseng, a kind of of Radix Panacis Quinquefolii substitute.
The enough Ramulus Uncariae Cum Uncis of described Cornu Saigae Tataricae flavour of a drug energy, Bombyx Batryticatus, Pheretima, Scolopendra, artificial Calculus Bovis, Scorpio, Cornu procaprae gutturosae, a kind of of Cornu Naemorhedi substitute; The enough Ramulus Uncariae Cum Uncis of Scorpio flavour of a drug energy, Bombyx Batryticatus, Pheretima, a kind of of Scolopendra substitute.
The contained adjuvant of Chinese medicine composition of the present invention can use dextrin, starch, lactose etc., and the best is a dextrin.
The multi-functional extraction concentrator of dynamic circulation that the preparation method of Chinese medicine composition of the present invention adopts, the concrete operations step is as follows:
A) pulverize: Cornu Saigae Tataricae powder is broken into fine powder (80～120 order); After Hirudo, Scorpio, the Eupolyphaga Seu Steleophaga drying (80～120 ℃), be ground into fine powder (80～120 order) with atomizer;
B) extract volatile oil: Rhizoma Chuanxiong, Radix Angelicae Sinensis, Rhizoma Acori Graminei are put in the extraction pot and are extracted volatile oil with the way of distillation, boiling back steam pressure≤0.04Mpa, 3～8 hours extraction times (the best is 5 hours).
Also can adopt supercritical CO
2Extraction extracts volatile oil
Gained volatile oil is put in the freezer standby, and water liquid device is in addition collected, and medicinal residues are standby.
C) ethanol extraction: Radix Salviae Miltiorrhizae is put in the alcohol extraction jar, uses the ethanol extraction secondary, boiling back steam pressure≤0.03Mpa, add for the first time 6 times of amount ethanol (50～100 ℃, the best is 80 ℃) backflow (70～120 minutes, best 90 minutes), add for the second time 4 times of amounts (50%～95%, the best is 75%) ethanol (50～100 ℃, the best is 80 ℃) backflow (50～90 minutes, the best is 70 minutes), filter, decompression filtrate recycling ethanol gets alcohol extract to the thick paste shape, and medicinal residues are standby.
D) water extraction: the above-mentioned medicinal residues and the Radix Astragali, Radix Paeoniae Rubra, Flos Carthami, Semen Persicae, Radix Polygalae are put in the water extraction jar, add (6～10 times, the best is 8 times) water gaging and decoct three times, each (1～4 hour, the best is 2 hours), boiling back steam pressure 0.03～0.04Mpa.Collecting decoction filters.
E) concentrate: water extraction filtrate and volatile oil extract back water liquid and merge the back to concentration tank, being concentrated into relative density is that 1.05～1.15 (50 ℃) the best is 1.11 (50 ℃), vacuum-0.07～-0.09Mpa, thickening temperature (40～100 ℃, the best is 50～65 ℃).
F) precipitate with ethanol: concentrated solution is put in the Alcohol-settling tank, adds slowly to add 95% ethanol and make the alcohol amount of containing reach (50%～75%, the best is 65%), after fully stirring, leaves standstill (8～20 hours, the best is 12 hours), filters.
G) reclaim ethanol: filtrate is put in the reclaim under reduced pressure jar, decompression recycling ethanol, and being concentrated into relative density is 1.10～1.20, the best is the thick paste of 1.15 (85 ℃), vacuum-0.07～-0.09Mpa, (40～100 ℃ of thickening temperatures, the best is 50～65 ℃), get water extract.
H) capsular preparation:
A ') water extract mixes with alcohol extract, is tiled in the vacuum drying oven vacuum drying.Vacuum-0.07～-0.098Mpa, 40～100 ℃ of temperature, the best is 60～70 ℃, gets dry extract;
B ') dried cream powder is broken into fine powder (80 order), and dry run also can use spray drying method to carry out, and directly obtains dried cream powder;
C ') dried cream powder adds Scorpio, Hirudo, Eupolyphaga Seu Steleophaga fine powder, is blended into an amount of (the best is 5%) dextrin and Cornu Saigae Tataricae powder, artificial Calculus Bovis, sieves mix homogeneously, 21 rev/mins of mixer rotating speeds, incorporation time (10～50, the best is 30 minutes);
D ') uses 95% alcohol granulation, the granulation time (3～10 minutes, the best is 5 minutes);
E ') wet granular is tiled in the drying baker, drying.The about 2cm of shop layer thickness, baking temperature (50～100 ℃, the best is 60～80 ℃);
F ') granulate is 14 purpose screen cloth granulate with the order number;
G ') spray into volatile oil such as above-mentioned Rhizoma Chuanxiong, sealing was placed 20～50 minutes, and the best is 30 minutes;
H ') encapsulated.Every dress 0.4g;
I ') aluminum-plastic composite membrane～aluminium foil blister package, every plate is adorned 4, and finished product packing dispatches from the factory.
Embodiment 1
The Radix Astragali 480, Radix Salviae Miltiorrhizae 60, Radix Paeoniae Rubra 60, Rhizoma Chuanxiong 160, Radix Angelicae Sinensis 160, Flos Carthami 60, Hirudo 40, Eupolyphaga Seu Steleophaga 90, Semen Persicae 60, artificial Calculus Bovis 15, Cornu Saigae Tataricae 40, Scorpio 60, Radix Polygalae 160, Rhizoma Acori Graminei 60.
By above prescription ratio, make capsule according to the preparation method of above-mentioned Chinese medicine composition.
Embodiment 2
The Radix Astragali 660, Radix Salviae Miltiorrhizae 160, Radix Paeoniae Rubra 160, Rhizoma Chuanxiong 60, Radix Angelicae Sinensis 60, Flos Carthami 160, Hirudo 90, Eupolyphaga Seu Steleophaga 40, Semen Persicae 160, artificial Calculus Bovis 40, Cornu Saigae Tataricae 15, Scorpio 140, Radix Polygalae 60, Rhizoma Acori Graminei 160.
By above prescription ratio, make capsule according to the preparation method of above-mentioned Chinese medicine composition.
Embodiment 3
The Radix Astragali 570, Radix Salviae Miltiorrhizae 114, Radix Paeoniae Rubra 114, Rhizoma Chuanxiong 114, Radix Angelicae Sinensis 114, Flos Carthami 114, Hirudo 66.5, Eupolyphaga Seu Steleophaga 66.5, Semen Persicae 114, artificial Calculus Bovis 28.5, Cornu Saigae Tataricae 28.5, Scorpio 95, Radix Polygalae 114, Rhizoma Acori Graminei 114.
By above prescription ratio, make capsule according to the preparation method of above-mentioned Chinese medicine composition.
Embodiment 4
Radix Codonopsis 500, Radix Salviae Miltiorrhizae 100, Radix Paeoniae Rubra 100, Rhizoma Chuanxiong 100, Radix Angelicae Sinensis 100, Flos Carthami 100, Hirudo 100, Eupolyphaga Seu Steleophaga 80, Semen Persicae 100, artificial Calculus Bovis 30, Cornu Saigae Tataricae 30, Scorpio 100, Radix Polygalae 100, Rhizoma Acori Graminei 100.
By above prescription ratio, make capsule according to the preparation method of above-mentioned Chinese medicine composition.
Embodiment 5
The Radix Astragali 560, Radix Salviae Miltiorrhizae 100, Radix Paeoniae Rubra 90, Rhizoma Chuanxiong 100, Radix Angelicae Sinensis 100, Flos Carthami 80, Hirudo 70, Eupolyphaga Seu Steleophaga 70, Semen Persicae 100, artificial Calculus Bovis 40, Bombyx Batryticatus 120, Radix Polygalae 200, Rhizoma Acori Graminei 100.
By above prescription ratio, make capsule according to the preparation method of above-mentioned Chinese medicine composition.
Embodiment 6
The Radix Astragali 560, Radix Salviae Miltiorrhizae 100, Radix Paeoniae Rubra 90, Rhizoma Chuanxiong 100, Radix Angelicae Sinensis 100, Flos Carthami 80, Hirudo 70, Eupolyphaga Seu Steleophaga 70, Semen Persicae 100, Cornu Saigae Tataricae 25, Bombyx Batryticatus 100, Radix Polygalae 200, Rhizoma Acori Graminei 100.
By above prescription ratio, make capsule according to the preparation method of above-mentioned Chinese medicine composition.
Embodiment 7
The Radix Astragali 560, Radix Salviae Miltiorrhizae 100, Radix Paeoniae Rubra 90, Rhizoma Chuanxiong 100, Radix Angelicae Sinensis 100, Flos Carthami 80, Hirudo 70, Eupolyphaga Seu Steleophaga 70, Semen Persicae 100, Cornu Naemorhedi 30, Scorpio 95, Radix Polygalae 100, Rhizoma Acori Graminei 100.
By above prescription ratio, make capsule according to the preparation method of above-mentioned Chinese medicine composition.
By the above proportion of respectively writing out a prescription, according to the b in the above-mentioned Chinese medicine composition preparation method), c), d), e), f), g) method extract, a), b ' a ')) method pulverizing, vacuum drying, dried cream powder are broken, c ') method is mixed, add an amount of suitable excipient, granulate or tabletting, can be made into granule or tablet; Or directly packing is made powder; Add water dosing, fill, sterilization and can be made into mixture; Add that syrup is mixed, sterilization, the canned syrup that can be made into; Adding refined honey closes to stick together and can be made into honeyed pill; Extract and fine drug powder add water or sweet water pill can be made into the watered pill, water-honeyed pill; Or general reference is made concentrated pill, paste pill etc.B according to above-mentioned Chinese medicine composition), c), d), e), f), g) method extract, method a) is pulverized, c ') method mix, add an amount of Mel and be mixed and made into soft extract.
More than be optimum implementation with embodiment 3.
Its method of quality control of Chinese medicine composition with most preferred embodiment 3 preparations:
A) its encapsulated content granule content uniformity is ± 10%, makes regular check on capsular loading amount in the capsule filling process, and the failure is in time rejected, and guarantees that loading amount is between 0.36～0.44g scope.
B) content is that yellowish-brown is to sepia; The feeble QI raw meat, bitter in the mouth, little sweet.
C) contain astragaloside, tanshinone, cholic acid, Hyodeoxycholic Acid, effective ingredient such as peoniflorin.
A ') differentiates that with thin layer chromatography scanning measuring its every (0.4g) contains the Radix Astragali with astragaloside (C
41H
68O
14) meter, must not be less than 0.2mg.
B ') with organic solvent extraction, macroporous adsorbent resin separation and purification method Chinese medicine composition is separated; Differentiate its contained Tanshinone I I with thin layer chromatography
A, cholic acid, Hyodeoxycholic Acid, peoniflorin:
C ') with The suitable solvent Chinese medicine composition is disperseed, the microscopic features of differentiating its ingredient with microscopic examination are to differentiate its contained Scorpio and Eupolyphaga Seu Steleophaga fragment.
D) with the calcination destroy method impurity component in the Chinese medicine composition is separated; With colorimetry beavy metal impurity in the Chinese medicine composition and standard lead solution are compared, measure its content limit, its contained heavy metal must not cross 20/1000000ths.
E) limit test of microbe meets the regulation of Chinese Pharmacopoeia.
F) under room temperature was preserved, the effect duration of this Chinese medicine composition was 36 months.
The toxicity test of this Chinese medicine composition
1, acute toxicity test:
Chinese medicine composition extractum is pressed 80g/kg and is given the mouse stomach administration, does not have dead the generation, does not see movable unusual.Be equivalent to (3 times/day, 4/time, everyone presses 50kg calculating the 0.4g/ grain) more than 800 times of clinical consumption.Chinese medicine composition extractum is pressed 30g/kg and is given the rat oral gavage administration, does not have dead the generation, does not also see movable unusual.Be equivalent to more than 300 times of clinical consumption.
2, long term toxicity test:
Chinese medicine composition extractum with 18,8,4g/Kg/ day give the continuous gastric infusion of rat 3 months, outside a good appetite suddenly appearing in a serious disease dosage group clotting time obviously prolongs, other hematological indices is not had obvious influence; Blood parameters also there is not obvious influence; Organ coefficient, histopathologic examination also do not find tangible pathological change.
Below the clinical practice with above-mentioned traditional Chinese medicine composition for treating ischemic cerebrovascular (cerebral infarction) is illustrated.
By implementing the clinical trial protocol of State Food and Drug Administration's reply, the apoplexy patient has been carried out aphasis, facial paralysis, eye is levied, paralysis of upper extremities, refer to paralysis, the lower limb paralysis, the toe paralysis, comprehensive function, the tcm syndrome integration, the tcm syndrome single index, total effects, the tcm syndrome curative effect, onset time, hemorheology is learned, TCD, blood fat, the clinical observation of item such as CT infarct size, compare with this Chinese medicine composition and contrast medicine in the research, therapeutic evaluation standard according to the current international practice is estimated it, this Chinese medicine composition of results suggest is the treatment Qi deficiency blood stasis type, or has the obstruction of collateral caused by windphlegm type concurrently, or have the effective of the ischemic cerebrovascular of stirring of wind due to deficiency of YIN type (cerebral infarction) concurrently and the innerwear Chinese medicine preparation of safety.
Adopt randomized, double-blind layering counter point, clinical observation apoplexy patient 200 examples, wherein 100 examples are organized in treatment, each 4, every day 3 times, around taking, observe patient's language function, paralysis of upper extremities, refer to situation of change before and after the treatment of paralysis, lower limb paralysis, toe paralysis, comprehensive function and body of the tongue, tongue fur, all index of pulse condition, the result shows:
1, returned to behind patient's aphasis horizontal stretcher 0 fen and 1 fen person is 79 examples, accounts for 79%; Returned to 0 fen after the apoplexy facial paralysis treatment and 1 fen person is 93 examples, accounts for 93%; Paralysis of upper extremities recovers to return to the 0-2 person of branch 78% behind the horizontal stretcher; Referring to recover to return to behind the horizontal stretcher 0-2 by paralysis, to divide horizontal person be 79%; Lower limb paralysiss recovers to return to behind the horizontal stretcher 0-2, and to divide horizontal person be 89%; Toe paralysis recovers to return to behind the horizontal stretcher 0-2, and to divide horizontal person be 86%,
2, before and after the treatment patient comprehensive function level relatively, returning to 0-2 behind patient's comprehensive function horizontal stretcher, to divide horizontal person be 49%;
3, patient's picture of the tongue, pulse condition integration relatively have significance to recover after body of the tongue, tongue fur and the pulse condition three card treatments before and after the treatment;
4, treatment back patient's total effects compares, and the total effective rate after the treatment is 91.00%, and cure-remarkable-effectiveness rate is 53%,
5, the total effective rate after treatment back patient's tcm syndrome curative effect is relatively treated is 90.00%, and cure-remarkable-effectiveness rate treatment group is 23%,
6, treatment back patient's individual event tcm syndrome curative effect sees Table 1
Table 1 treatment back patient's individual event tcm syndrome curative effect
| Group | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Total effective rate | Cure-remarkable-effectiveness rate | |
| Hemiplegia stiff tongue and retardation in speech hemianesthesia | Treatment group treatment group treatment group | 98 87 59 | 28 33 41 | 0 0 0 | 59 34 15 | 11 20 3 | 88.78 77.01 94.92 | 28.57 37.93 69.49 |
| The crooked mouth and tongue pale complexion | Treatment group treatment group | 80 83 | 26 45 | 0 0 | 24 14 | 30 24 | 62.50 71.08 | 32.50 54.22 |
7, before and after the treatment patient blood rheology index height cut, plasma viscosity, packed cell volume, lowly cut, the Fibrinogen index all has significant difference, sees Table 2
Patient blood rheology index before and after table 2 treatment
| Group | The example number | Height is cut | Plasma viscosity | Packed cell volume | Low cutting | Fibrinogen | |
| The treatment group | After treating before treating | 100 100 | 5.30±1.80 4.99±1.51** | 1.67±0.24 1.61±0.27** | 30.51±20.28 27.73±20.55** | 8.74±2.68 8.37±2.34 | 3.30±0.97 2.99±0.81** |
In the group: * P＜0.05
**P＜0.01
8, the patient unusual person of transcranial doppler (TCD) index relatively treatment group TCD improvement rate after treating is 51.19% before and after the treatment; The every index of blood fat (CH, TG, HDL) all has significant difference P＜0.01 before and after the treatment; After blood pressure is relatively treated before and after the treatment significant difference P＜0.01 is arranged; Heart rate is relatively treated back heart rate there was no significant difference P＞0.05 before and after the treatment; The every index of patient's neurosigns all has improvement before and after the treatment
Untoward reaction does not all take place in the therapeutic process and after the treatment in 9, patient safety index there was no significant difference (P＞0.05) before and after the treatment.
More than every index and matched group relatively, the every index and the clinical efficacy of this Chinese medicine composition all are better than contrasting medicine, diseases such as treatment back sufferer hemiplegia, stiff tongue and retardation in speech, hemianesthesia are improved situations and obviously are better than similar medicine.
Claims (8)
1, a kind of Chinese medicine composition that is used for the treatment of cerebrovascular is characterized in that: be made of following flavour of a drug by weight:
The Radix Astragali 480～660, Radix Salviae Miltiorrhizae 60～160, Radix Paeoniae Rubra 60～160, Rhizoma Chuanxiong 60～160, Radix Angelicae Sinensis 60～160, Flos Carthami 60～160, Hirudo 40～90, Eupolyphaga Seu Steleophaga 40～90, Semen Persicae 60～160, artificial Calculus Bovis 10～40, Cornu Saigae Tataricae 10～40, Scorpio 50～140, Radix Polygalae 60～160, Rhizoma Acori Graminei 60～160 also have pharmaceutic adjuvant.
2, Chinese medicine composition according to claim 1 is characterized in that: the enough Radix Codonopsis of described Radix Astragali energy, Radix Ginseng, Radix Ginseng, Radix Ginseng Rubra, wild ginseng, a kind of of Radix Panacis Quinquefolii substitute.
3, Chinese medicine composition according to claim 1 is characterized in that: the enough Ramulus Uncariae Cum Uncis of described Cornu Saigae Tataricae flavour of a drug energy, Bombyx Batryticatus, Pheretima, Scolopendra, artificial Calculus Bovis, Scorpio, Cornu procaprae gutturosae, a kind of of Cornu Naemorhedi substitute; The enough Ramulus Uncariae Cum Uncis of Scorpio flavour of a drug energy, Bombyx Batryticatus, Pheretima, a kind of of Scolopendra substitute.
4, Chinese medicine composition according to claim 1 is characterized in that: described pharmaceutic adjuvant is one of dextrin, starch, lactose.
5, a kind of preparation method that is used for the treatment of the Chinese medicine composition of cerebrovascular, its method may further comprise the steps:
A) pulverize: Cornu Saigae Tataricae powder is broken into fine powder (80～120 order); After Hirudo, Scorpio, the Eupolyphaga Seu Steleophaga drying (80～120 ℃), be ground into fine powder (80～120 order) with atomizer;
B) extract volatile oil: Rhizoma Chuanxiong, Radix Angelicae Sinensis, Rhizoma Acori Graminei are put in the extraction pot and are extracted volatile oil with the way of distillation, boiling back steam pressure≤0.04Mpa, and 3～8 hours extraction times, gained volatile oil is put in the freezer standby, and water liquid device is in addition collected, and medicinal residues are standby;
C) ethanol extraction: Radix Salviae Miltiorrhizae is put in the alcohol extraction jar, use the ethanol extraction secondary, boiling back steam pressure≤0.03Mpa, adding for the first time 6 times of amount ethanol (50～100 ℃) refluxed 1.5 hours, add for the second time 4 times of amounts (50%～95%) ethanol (50～100 ℃) and refluxed 70 minutes, filter, decompression filtrate recycling ethanol is to the thick paste shape, get alcohol extract, medicinal residues are standby;
D) water extraction: above-mentioned b), c) medicinal residues and the Radix Astragali, Radix Paeoniae Rubra, Flos Carthami, Semen Persicae, Radix Polygalae in the step put in the water extraction jar, add (6～10) times water gaging and decoct three times, each (1～4) hour, boiling back steam pressure 0.03～0.04Mpa, collecting decoction filters;
E) concentrate: water extraction filtrate and volatile oil extract back water liquid and merge the back to concentration tank, and being concentrated into relative density is 1.05～1.15 (50 ℃), vacuum-0.07～-0.09Mpa, thickening temperature (40～100 ℃);
F) precipitate with ethanol: concentrated solution is put in the Alcohol-settling tank, adds slowly to add 95% ethanol and make the alcohol amount of containing reach (50%～75%), after fully stirring, leaves standstill 8～20 hours, filters;
G) reclaim ethanol: filtrate is put in the reclaim under reduced pressure jar, decompression recycling ethanol, and being concentrated into relative density is the thick paste of 1.10～1.20 (85 ℃), vacuum-0.07～-0.09Mpa, thickening temperature (40～100 ℃) gets water extract.
H) capsular preparation:
A ') water extract mixes with alcohol extract, is tiled in the vacuum drying oven vacuum drying.Vacuum-0.07～-0.098Mpa, 40～100 ℃ of temperature get dry extract;
B ') dried cream powder is broken into fine powder (80 order);
C ') dried cream powder adds Scorpio, Hirudo, Eupolyphaga Seu Steleophaga fine powder, is blended into an amount of dextrin and Cornu Saigae Tataricae powder, artificial Calculus Bovis, sieves mix homogeneously, 21 rev/mins of mixer rotating speeds, incorporation time (10～50 minutes);
D ') uses 95% alcohol granulation, 3～10 minutes granulation time;
E ') wet granular is tiled in the drying baker, drying, the about 2cm of shop layer thickness, baking temperature (50～100 ℃);
F ') granulate is 14 purpose screen cloth granulate with the order number;
G ') spray into above-mentioned b) volatile oil such as Rhizoma Chuanxiong in the step, sealing was placed 20～50 minutes;
H ') encapsulated, every capsules dress 0.4g;
I ') aluminum-plastic composite membrane～aluminium foil blister package, every plate is adorned 4, and finished product packing dispatches from the factory.
6, the Chinese medicine composition of making according to claim 1,5 is characterized in that:
A) in the h step of described method, its encapsulated granule content uniformity is ± 10%, and scope is between 0.36～0.44g.
B) content is that yellowish-brown is to sepia; The feeble QI raw meat, bitter in the mouth, little sweet.
C) contain astragaloside, Tanshinone I I A, cholic acid, effective ingredient such as peoniflorin.
D) the beavy metal impurity content limit must not be 20/1000000ths.
E) limit test of microbe meets the regulation of Chinese Pharmacopoeia.
F) under room temperature was preserved, the effect duration of this Chinese medicine composition was 36 months.
7, method according to claim 5 is characterized in that: in the h step of described method, extract can be made pill, powder, granule, tablet, soft extract, mixture or syrup.
8,, be used for the treatment of ischemic cerebrovascular (cerebral infarction) according to the Chinese medicine composition in the described preparation method of claim 5.
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