CN102512562B - Pharmaceutical composition for treating ischemic cerebrovascular diseases and preparation method and applications thereof - Google Patents
Pharmaceutical composition for treating ischemic cerebrovascular diseases and preparation method and applications thereof Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition for treating ischemic cerebrovascular diseases, which relates to a preparation prepared from the following crude drugs in proportioning by weight: 21-36 parts of Astragalus mongholicus, 8.4-15.6 parts of ginseng, 8.4-15.6 parts of Angelica sinensis, 8.4-15.6 parts of Ligusticum wallichii, 4.2-7.8 parts of leech, 10.5-19.5 parts of radix paeoniae alba, 8.4-15.6 parts of rhizoma cyperi and 14.26 parts of twotooth achyranthes. The invention also discloses a preparation method for the pharmaceutical composition and applications of the pharmaceutical composition. According to the pharmaceutical composition disclosed by the invention, thrombopoiesis can be reduced; the brain infarct volume can be reduced; and the ischemic cerebrovascular diseases can be effectively treated and prevented, such as cerebral thrombosis, cerebral embolism, cerebral apoplexy and the like; and a new selection is provided for clinical medication.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of ischemic cerebrovascular and its production and use.
Background technology
Ischemic cerebrovascular is because of the brain blood supply obstacle, to cause a kind of multiple disease of focal lesion, comprises transient ischemic attack (TIA), cerebral thrombosis, cerebral embolism, apoplexy etc.Doctor trained in Western medicine does not have specific medicament to ischemic cerebrovascular, and its treatment is that to keep on a diet and strengthen physical training be main, and Drug therapy is auxiliary.Its Drug therapy is mainly taked blood vessel dilating (with calcium ion antagonists such as cinnarizine, nimodipine, flunarizines) and is reduced the measures such as lipid concentration (with Inositol Hexanicotinate, Max EPA, zhibituo, FENOBRATE top grade) of blood, sometimes be aided with activation neurocyte (with γ-ammino acid, pyritionol hydrochloride neuroxin, gain shake, cerebrolysin etc. happily), but curative effect is all of inadequate achievement, there is no treatment good medicine.And this class medicine life-time service can bring serious side effect to human body, the symptoms such as dizzy pain, flushing, tinnitus, dizzy, blood pressure drops, tachycardia occur, and Patients with Ischemic Cerebrovascular Disease often needs again long-term prescription.Moreover, these Western medicine of life-time service also can produce drug resistance, and in addition, glaucoma, cerebral hemorrhage, intracranial hypertension patient also must avoid use.
Clinically, the Chinese patent medicine of more existing treatment cerebrovascular disease, but the kind that belongs to " emergency ", and the medicine of " emergency " has more serious toxic and side effects more, the most very, Chinese patent medicine is no exception for Western medicine, " emergency " during urgency only, and should not take for a long time.Not only price is very expensive as ZIXUEDAN, Zhibao Dan etc., and contains a lot of fragrance and disperse composition, and very consumption is hindered energy and blood of human body body fluid, and clothes are unfavorable on the contrary to the state of an illness for a long time.Cerebrovascular disease often needs to take medicine all the life, and in " emergency " afterwards, need badly and continue to take effective treatment, and this continual cure that follows up afterwards in " emergency ", be only treatment most important, that effect a permanent cure, but clinically, exactly Western medicine lacks the effective kind of this respect, and also relative deficiency of relevant Chinese patent medicine.The Chinese medicine of most treatment cerebrovascular disease, be and contain more flavour of a drug, for example: number of patent application: CN200810202757.3, it discloses a kind of Chinese powder medicine that is used for the treatment of apoplexy, comprising: the Radix Astragali, Scorpio, Rhizoma Gastrodiae, Radix Notoginseng, Hirudo, Flos Carthami, Rhizoma Chuanxiong, Bombyx Batryticatus, Carapax et Plastrum Testudinis, Cortex Moutan, Fructus Gardeniae, Borneolum Syntheticum, the big gun first, the 29 flavor medical materials such as Radix Glehniae, and wherein Scorpio toxicity is stronger.Number of patent application: CN200510041960.3 and for example, it discloses a kind of medicine of preventing and treating apoplexy, comprising the 60 kinds of traditional Chinese medicines materials such as the Radix Astragali, Radix Ginseng, Radix Pseudostellariae, forms.These Chinese medicine compound have increased the weight of patient's medical treatment burden greatly.
At present, be badly in need of precise and appropriate, the evident in efficacy medicine that is used for the treatment of cerebrovascular disease of a kind of compatibility.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition for the treatment of ischemic cerebrovascular; Another object of the present invention is to provide preparation method and the purposes of this pharmaceutical composition.
The invention provides a kind of pharmaceutical composition for the treatment of ischemic cerebrovascular, it is the preparation that the crude drug by following weight proportion is prepared from:
Radix Astragali 21-36 part, Radix Ginseng 8.4-15.6 part, Radix Angelicae Sinensis 8.4-15.6 part, Rhizoma Chuanxiong 8.4-15.6 part, 4.2 parts-7.8 parts of Hirudos, Radix Paeoniae Alba 10.5-19.5 part, Rhizoma Cyperi 8.4-15.6 part, Radix Achyranthis Bidentatae 14-26 part.
Further, it is the preparation that the crude drug by following weight proportion is prepared from:
30 parts of the Radixs Astragali, 12 parts of Radix Ginsengs, 12 parts of Radix Angelicae Sinensis, 12 parts of Rhizoma Chuanxiongs, 6 parts of Hirudos, 15 parts of the Radix Paeoniae Albas, 12 parts of Rhizoma Cyperis, 20 parts of Radix Achyranthis Bidentataes.
Further, described Hirudo is Hirudo.
Wherein, described preparation is take the water of the medicated powder of crude drug or crude drug or extractive with organic solvent as active component, adds what pharmaceutically available adjuvant or complementary composition were prepared from.
Wherein, described preparation is oral formulations or ejection preparation.
Further, described oral formulations is powder, granule, pill, hard capsule, soft capsule, tablet, oral liquid or drop pill.
The present invention also provides the preparation method of above-mentioned pharmaceutical composition, and it comprises following operating procedure:
(1) by prescription weight proportion weighting raw materials;
(2) crude drug is extracted with water or organic solvent, extract adds that pharmaceutically available adjuvant or complementary composition are prepared into conventional formulation; Or
(3) crude drug is pulverized, sieved, add that pharmaceutically available adjuvant or complementary composition are prepared into preparation.
The present invention also provides the purposes of aforementioned pharmaceutical compositions in the medicine of preparation treatment ischemic cerebrovascular.
Wherein, described medicine is the medicine for the treatment of cerebral ischemia, cerebral thrombosis, cerebral embolism, apoplexy.
The present invention also provides the purposes of aforementioned pharmaceutical compositions in the antithrombotic medicine of preparation.
" medication is as used military forces " is the original theory of Chinese medicine of very science, and each medicine tight compatibility all linked with one another as arraying troops for battle in prescription is its effective means that is better than the Western medicine formula.The Chinese medicinal formulae theory is thought, each prescription not only needs according to etiology and pathogenesis, selects the suitable appropriate compatibility of medicine, simultaneously also should meet the basic structure of prescription, i.e. the prescription theory of " monarch, minister, help, make ".Namely, Chinese medicinal formulae is the organic proportioning of Chinese medicine that is based upon on the comprehensive judgement basis of disease pathogenesis, in medical square tube cross too many levels, many target spots and integrate the biological mechanism of regulating, to chronic difficult diseases, particularly cause of disease disease complicated, the treatment difficulty regulates and controls as cerebrovascular disease, can obtain the treatment effect better, more lasting than Western medicine, and this curative effect is to be based upon on the accurate instruction of the original theory of traditional Chinese medical science tradition, prescription of the present invention is just being followed this principle.
In the present composition, the Radix Astragali, Radix Ginseng, Radix Angelicae Sinensis, QI invigorating, hemopoietic, make fullly and not empty, is monarch drug altogether; Rhizoma Chuanxiong, Hirudo, promoting the circulation of blood and the resistance of not becoming silted up, assistant is with the Rhizoma Cyperi circulation of qi promoting, to promote the merit of Rhizoma Chuanxiong, the logical stasis of blood of Hirudo promoting the circulation of blood; And assistant is adjusted blood (nourshing blood and promoting blood circulation) with the Radix Paeoniae Alba.Simultaneously, motherland's traditional medical theory thinks that again brain occupies people's height top part, solve brain hematogenous blockage or headache and dizzy, necessary " conducting blood to flow downwards " " subduing the hyperactivity of YANG wind sun ", and the Radix Achyranthis Bidentatae first-selected kind of conducting blood to flow downwards just, the Radix Paeoniae Alba also has the merit of subduing the hyperactivity of YANG wind sun, and two medicines share as making medicine.Prescription monarch drug of the present invention, ministerial drug, adjuvant drug, make medicine clear and definite, Each performs its own functions closely cooperates again, meets the compatibility of medicines in a prescription theory of " monarch ", and each medicine coordinates precise and appropriate, complements each other, and has greatly strengthened drug effect.
Pharmaceutical composition of the present invention can reduce thrombosis, and the ischemic cerebrovascular such as cerebral thrombosis, cerebral embolism and apoplexy can effectively be treated and prevent to cerebral infarct volume, for clinical application provides a kind of new selection.
The specific embodiment
The preparation of embodiment 1 pharmaceutical composition of the present invention
Get Radix Astragali 30g, Radix Ginseng 12g, Radix Angelicae Sinensis 12g, Rhizoma Chuanxiong 12g, Hirudo 6g, Radix Paeoniae Alba 15g, Rhizoma Cyperi 12g, Radix Achyranthis Bidentatae 20g.Each flavour of a drug take according to quantity, and the intense fire decocting changes slow fire and decocted 30 minutes again after boiling, obtain.
The preparation of embodiment 2 pharmaceutical compositions of the present invention
Radix Astragali 21g, Radix Ginseng 15.6g, Radix Angelicae Sinensis 15.6g, Rhizoma Chuanxiong 15.6g, Hirudo 7.8g, Radix Paeoniae Alba 19.5g, Rhizoma Cyperi 15.6g, Radix Achyranthis Bidentatae 26g, decoct with water 3 times, uses 6-10 times of water of medical material weight at every turn, decocts 15-30 minute at every turn, merges decocting liquid; Get again Hirudo 3g, after pulverizing, add into the liquid stirring evenly, obtain.
The preparation of embodiment 3 pharmaceutical compositions of the present invention
Radix Astragali 36g, Radix Ginseng 8.4g, Radix Angelicae Sinensis 8.4g, Rhizoma Chuanxiong 8.4g, Hirudo 4.2g, the Radix Paeoniae Alba 10.5, Rhizoma Cyperi 8.4g, Radix Achyranthis Bidentatae 14g, decoct with water 2 times, each 8-12 times of water with medical material weight, each 20-40 minute that decocts, merge decocting liquid, and is concentrated, add dextrin, soluble starch, wet granulation, drying, obtain.
Below by test example, illustrate beneficial effect of the present invention.
Clinical (outpatient service) treatment situation of test example 1 pharmaceutical composition of the present invention
(1) patient's selection standard
1, cerebral ischemia: hemiplegia, hemianesthesia appear in the patient, feel to go down, visual disorder, bulbar paralysis, dizzy, headache, tinnitus, dark and dim eyesight, facial numbness, myasthenia of limbs, drinking-water choke cough, one or more symptoms wherein such as babble, after sustainable several minutes of these symptoms or a few hours, can recover normal fully, but all in 24 hours, recover normal, but above-mentioned symptom shows effect repeatedly.The brain CT examination, normal or visible lacunar infarction kitchen range.
2, cerebral thrombosis: patient age is higher, the risk of strokes such as arteriosclerosis and hypertension are arranged or transient ischemic attack was arranged, the signs such as premorbid often has that limbs are numb, ineffective, the slurred speech of motion, dizzy, blurred vision, often in sleep or morbidity morning, suffer from limb movable unable or stiff, speak ambiguous or aphasia, drinking-water is sent out and is choked, visible disturbance of consciousness, hemiplegia, aphasia sign obviously and be the progressive state that increases the weight of, but how without severe headache, vomiting.The density regions of the visible cerebral ischemia pathological changes of CT scan.Cerebral angiography shows stricture of artery, obturation and focus abnormal vascular on every side.
3, cerebral embolism: patient age is lighter, and is many without above-mentioned cerebral ischemia medical history, and the medical histories such as rheumatic heart disease, atrial fibrillation are often arranged, excited, exert all one's strength, move or activity in fall ill, most headache, vomiting and disturbance of consciousness, hemiplegia, the normal generation suddenly of aphasia.CT examination is positive or meet the list of vascularity or multiple location cerebral tissue low-density or the inspection of cranium brain magnetic resonance imaging and see ischemia or the edema sexually transmitted disease (STD) kitchen range that meets vascularity.
(2) treatment standard:
Evident in efficacy: patient's subjective symptoms obviously alleviates, and test rating has to a certain degree improvement simultaneously.
Curative effect is obvious: the above-mentioned one (subjective symptoms and test rating) of getting.
Certain effect is arranged: subjective symptoms alleviates to some extent, or index slightly is improved.
Invalid: symptom still, do not improve by index.
(3) Therapeutic Method:
1, embodiment 1, the made medicinal liquid of embodiment 2, take advantage of when warm at every turn and take 200 to 400ml, or daily 1 bowl, the rice bowl used of having a meal, 2 to 3 times on the one (according to conditions of patients weight, physical strength, age size etc., grasping flexibly), take according to quantity on time, the drug withdrawal that serve on 10 continued to take after having a rest 1 again, if also temporarily withdraw when the new trouble disease such as flu or diarrhoea is arranged.
2, adhere to patting as much as possible, harmonize the body that especially to suffer from limb etc. crucial local every day, movable relevant local (limbs, refer to, tongue, clicking the teeth, rotate eyeball etc.).
3, note and science conditioning daily life (as regular with feed in had a rest, avoid anxious state of mind and fatigue, do not eat or eat less the food of the unfavorable rehabilitation such as cholesterol level height, eat blood pressure lowering more, reduce the food that blood fat etc. is conducive to rehabilitation, etc.).
(4) therapeutic outcome:
With Patients with Ischemic Cerebrovascular Disease 87 examples such as embodiment 1, embodiment 2 medicine composite for curing cerebral thrombosiss, cerebral embolism, apoplexy (can normally take Chinese medicine person), obtained comparatively satisfied curative effect.Treatment time: difference according to the difference of the concrete conditions such as each conditions of patients weight, age size, physical strength and to some extent, generally about 3～12 months.By above-mentioned treatment standard, in 87 routine patients, there are 18 routine effects remarkable, 42 routine successfuls, 14 examples have certain effect, 13 routine DeGrains (invalid), total effective rate reaches 85%.
The impact of test example 2 prescription of the present invention on the experimental rat cerebral infarction
60 of male SD rats, body weight 200 ± 20g, be divided into 4 groups (concrete grouping refers to following table 1), 15 every group at random.With starvation method, tired method and raise with 10% cholesterol, the contour fat food of 10% Adeps Sus domestica and make empty blood stasis syndrome model, with the common carotid artery suture method, make local cerebral infarction model (the blank group is plug wire not, and all the other crawls, operation etc. are all with another three groups).Get embodiment 1 gained pharmaceutical composition, with distilled water, be made into required solution, wherein high dose concentration is 3.0g crude drug/ml, and low dosage concentration is 1.5g crude drug/ml.
The high and low dose group is respectively by 20 times, 10 times of people's dosage, and namely 10g crude drug/kg, 5g crude drug/kg be to rat oral gavage, and blank group, model group the capacity normal saline gavage such as press in contrast, every day 1 time, treat continuously (3 week) on the 21st.Each treated animal all has death (blank group is dead less) in various degree in experimentation.After treatment finishes, get at random 10 (only) specimen for every group, sacrificed by decapitation, get its brain, and it is inserted to cryosel 10min, get the brain sheet of the even 2mm of the being cut into thickness of its coronalplane, and being placed in fast the 2%TTC solution of 37 ℃, dyeing 30min, fix with 40g/L formaldehyde, with computer pathological image analyser and trapezoidal method, calculate its infarct volume, each brain sheet infarct volume sum is its Infarction volume.
The impact of table 1 pharmaceutical composition of the present invention on the experimental rat cerebral infarction
| Grouping | The Mus number | Drug dose (g/kg) | The cerebral infarction scope accounts for homonymy brain % |
| High dose group | 15→10 | 10.00 | 19 |
| Low dose group | 15→10 | 5.00 | 22.24±4.15 |
| Blank group matched group | 15→10 | Deng the capacity normal saline | 0.00±0.00 |
| Model group | 15→10 | Deng the capacity normal saline | 34 |
Result statistics SNK-q method, pharmaceutical composition high and low dose group of the present invention is compared with blank group, model group, and its difference significance (P<0.01) shows that pharmaceutical composition of the present invention can obviously reduce the cerebral infarction scope of laboratory animal.
Test example 3 pharmaceutical composition of the present invention is on the thrombotic impact of experimental rat
45 of SD rats, body weight 200 ± 20g, male and female half and half, be divided into 3 groups (concrete grouping refers to following table 2), 15 every group at random.Get the pharmaceutical composition of embodiment 1, with distilled water, be made into required solution, wherein high dose concentration is 3.0g crude drug/ml, and low dosage concentration is 1.5g crude drug/ml.
The high and low dose group is respectively by 20 times, 10 times of people's dosage, and namely 10g crude drug/kg, 5g crude drug/kg are to rat oral gavage, and blank group, by waiting capacity normal saline gavage in contrast, every day 1 time, is treated (3 week) on the 21st continuously.Death in various degree occurs in the high and low dose treated animal in experimentation, after treatment finishes, get at random 10 (only) specimen for every group, 0.5h after the last administration, its common carotid artery of peeling operation and external jugular vein, make artery and vein and wear road, art finishes opens blood flow, circulate and stopped blood flow in 30 minutes, taking-up is worn silk thread in road and is weighed, and removing the dry silk line is heavily wet weight of thrombus.Experimental result sees the following form 2:
Table 2 pharmaceutical composition of the present invention is on the thrombotic impact of experimental rat
| Grouping | The Mus number | Drug dose (g/kg) | Wet weight of thrombus (mg) |
| High dose group | 15→10 | 10.00 | 20.71±7.31 |
| Low dose group | 15→10 | 5.00 | 23.43±5.68 |
| The blank group | 15→10 | Deng the capacity normal saline | 34.86±10.64 |
Result is learned t check by statistics, and pharmaceutical composition high and low dose group of the present invention is compared with the blank group, and its difference significance (P<0.05) shows the thrombosis of pharmaceutical composition energy intervention experiment animal of the present invention.
In sum, pharmaceutical composition of the present invention can reduce thrombosis, and the ischemic cerebrovascular such as cerebral thrombosis, cerebral embolism and apoplexy can effectively be treated and prevent to cerebral infarct volume, for clinical application provides a kind of new selection.
Claims (11)
1. pharmaceutical composition for the treatment of ischemic cerebrovascular is characterized in that: it is the preparation that the crude drug by following weight proportion is prepared from:
Radix Astragali 21-36 part, Radix Ginseng 8.4-15.6 part, Radix Angelicae Sinensis 8.4-15.6 part, Rhizoma Chuanxiong 8.4-15.6 part, 4.2 parts-7.8 parts of Hirudos, Radix Paeoniae Alba 10.5-19.5 part, Rhizoma Cyperi 8.4-15.6 part, Radix Achyranthis Bidentatae 14-26 part.
2. pharmaceutical composition according to claim 1 is characterized in that: it is the preparation that the crude drug by following weight proportion is prepared from:
30 parts of the Radixs Astragali, 12 parts of Radix Ginsengs, 12 parts of Radix Angelicae Sinensis, 12 parts of Rhizoma Chuanxiongs, 6 parts of Hirudos, 15 parts of the Radix Paeoniae Albas, 12 parts of Rhizoma Cyperis, 20 parts of Radix Achyranthis Bidentataes.
3. pharmaceutical composition according to claim 1 and 2, it is characterized in that: described Hirudo is Hirudo.
4. pharmaceutical composition according to claim 1 and 2 is characterized in that: described preparation is take the water of the medicated powder of crude drug or crude drug or extractive with organic solvent as active component, adds what pharmaceutically available adjuvant or complementary composition were prepared from.
5. pharmaceutical composition according to claim 1 and 2, it is characterized in that: described preparation is oral formulations or ejection preparation.
6. pharmaceutical composition according to claim 5, it is characterized in that: described oral formulations is powder, granule, pill, hard capsule, soft capsule, tablet or oral liquid.
7. pharmaceutical composition according to claim 5, it is characterized in that: described oral formulations is drop pill.
8. the preparation method of the described pharmaceutical composition of claim 1-7 any one, it is characterized in that: it comprises following operating procedure:
(1) by prescription weight proportion weighting raw materials;
(2) crude drug is extracted with water or organic solvent, extract adds that pharmaceutically available adjuvant or complementary composition are prepared into conventional formulation; Or
(3) crude drug is pulverized, sieved, add that pharmaceutically available adjuvant or complementary composition are prepared into preparation.
9. the purposes of the described pharmaceutical composition of claim 1-7 any one in the medicine of preparation treatment ischemic cerebrovascular.
10. purposes according to claim 9 is characterized in that: described medicine is the medicine for the treatment of cerebral ischemia, cerebral thrombosis, cerebral embolism, apoplexy.
11. the purposes of the described pharmaceutical composition of claim 1-7 any one in the antithrombotic medicine of preparation.
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1951481A (en) * | 2006-10-12 | 2007-04-25 | 张元道 | Medicament for treating cerebral thrombosis |
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| CN1951481A (en) * | 2006-10-12 | 2007-04-25 | 张元道 | Medicament for treating cerebral thrombosis |
Non-Patent Citations (4)
| Title |
|---|
| 戚刚.补脑通脑汤治疗缺血性中风恢复期.《中国民族民间医药》.2010,(第24期), |
| 治疗冠心病中药使用频率的研究分析;黄素芳等;《中药新药与临床药理》;20090725;第20卷(第04期);395-396 * |
| 补脑通脑汤治疗缺血性中风恢复期;戚刚;《中国民族民间医药》;2010(第24期);77 * |
| 黄素芳等.治疗冠心病中药使用频率的研究分析.《中药新药与临床药理》.2009,第20卷(第04期), |
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