CN1772052A - Chinese medicine composition for treating cerebral hemorrhage and its prepn - Google Patents
Chinese medicine composition for treating cerebral hemorrhage and its prepn Download PDFInfo
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- CN1772052A CN1772052A CNA2005100867633A CN200510086763A CN1772052A CN 1772052 A CN1772052 A CN 1772052A CN A2005100867633 A CNA2005100867633 A CN A2005100867633A CN 200510086763 A CN200510086763 A CN 200510086763A CN 1772052 A CN1772052 A CN 1772052A
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Abstract
The present invention is one kind of Chinese medicine composition for treating cerebral hemorrhage and is preparation process. The Chinese medicine composition consists of effective components from motherwort, giant knotweed, leech, gentian, and buffalo horn or rhinoceros horn; and may be prepared into medicine powder, tincture, capsule, tablet, micro pill and other forms. The Chinese medicine composition has the function of promoting blood circulation to disperse blood clots, and can alleviate hemorrhagic apoplexy cerebral edema, promote the absorption of hematoma and disease focus repair, improve the ischemic and anoxic state of nerve tissue around hematoma, protect damaged brain cell and promote restoring of the nerve function.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, specifically is a kind of Chinese medicine composition for the treatment of cerebral hemorrhage, the invention still further relates to the preparation method of this Chinese medicine composition.
Background technology
Cerebral hemorrhage be in, common complaint among the elderly, frequently-occurring disease, account for the 20-40% of all acute cerebrovascular disease, have data to show, after 35 years old, every increase of age 10 years old, sickness rate then increases by 1 times, along with Chinese society progressively enters aging society, the generation of this disease also presents the trend of continuous rising.Primary disease fatality rate, disability rate are all high, and most survivor leaves serious deformity, have a strong impact on health of people.Comprehensive therapy is generally adopted in its treatment at present, comprises the Western medicine colligation treatment, and traditional medicine synthetic therapy and combination of Chinese and Western medicine Comprehensive Treatment are wherein better in effect aspect mortality rate and the disability rate with therapy of combining Chinese and Western medicine, but still lack effective medicine.
Summary of the invention
The purpose of this invention is to provide a kind of Chinese medicine composition for the treatment of hyperlipidemia.Another object of the present invention just provides the preparation method of this Chinese medicine composition.
The acute hemorrhagic apoplexy belongs to traditional Chinese medical science mass formed by blood stasis, and stagnation of blood stasis is hemorrhagic apoplexy the most basic pathogenesis of acute stage, and blood circulation promoting and blood stasis dispelling is the key of treatment.Herba Leonuri, Hirudo, Rhizoma Polygoni Cuspidati all have blood circulation invigorating efficacies in the prescription; can alleviate the hemorrhagic apoplexy cerebral edema; promote the reparation of absorption of hematoma and focus; improve the hypoxic-ischemic state of hematoma peripheral nerve tissue; protection damage back brain cell; promote the recovery of patient's nervous function, but Radix Gentianae, Cornu Bubali clearing away heat and cooling blood alleviates intracerebral hemorrhage complicated disease.
Chinese crude drug of the present invention source is as follows:
Herba Leonuri is the herb of labiate Herba Leonuri or Herba leonuri pseudoma cranthi or Herba Leonuri Sibirici or Turkey's Herba Leonuri.Blood circulation promoting and blood stasis dispelling, regulating menstruation are arranged, the effect of the water that disappears.
Rhizoma Polygoni Cuspidati is a polygonaceae plant Rhizoma Polygoni Cuspidati rhizome, have dispel the wind, dampness removing, removing blood stasis with potent drugs, the effect of stimulating the menstrual flow.
Hirudo is all of Hirudinidae animal blood-eating hirudo, eurysome golden thread leech, dark brown trematodiasis.The effect of have removing blood stasis, removing blood stasis, stimulating the menstrual flow.
Radix Gentianae is the root and rhizome of gentianaceae plant Radix Gentianae and three flower Radix Gentianae.Tool liver heat removing gallbladder excess-fire is except that the effect of damp-heat in lower-JIAO.
Cornu Bubali is the angle of Bovidae plant Babalus bubalis L..Tool heat clearing away, removing heat from blood, antidotal effect.
Cornu rhinocerotis is the angle of Rhinocerotidae animal Rhinoceros unicornis, rhinoceros sondaicus, rhinoceros sumatrensis etc., tool clearing away heat and cooling blood, arresting convulsion antidotal effect.
The weight ratio that effective ingredient of the present invention prepares raw material is: Herba Leonuri 1-120, Rhizoma Polygoni Cuspidati 1-120, Hirudo 1-18, Radix Gentianae 1-19, Cornu Bubali 1-120.
Be preferably: Herba Leonuri 10-90, Rhizoma Polygoni Cuspidati 10-90, Hirudo 3-15, Radix Gentianae 3-15, Cornu Bubali 10-90.
More preferably: Herba Leonuri 40-70, Rhizoma Polygoni Cuspidati 20-40, Hirudo 4-8, Radix Gentianae 6-12, Cornu Bubali 20-40.
Wherein Cornu Bubali can be a Cornu rhinocerotis, and consumption is 1/10 of a Cornu Bubali.
The preparation of Chinese medicine composition of the present invention can be that above-mentioned raw material of Chinese medicine directly is ground into fine powder, mixes again and/or with pharmaceutically acceptable carrier; Or raw material of Chinese medicine directly is ground into coarse powder, and add ethanol extraction again and obtain, or continue to be condensed into dry extract, mix again and/or with pharmaceutically acceptable carrier;
Chinese medicine composition of the present invention be preferably as follows preparation: with the Herba Leonuri extracting in water, extracting solution concentrates, precipitate with ethanol; Cornu Bubali, Hirudo, Radix Gentianae, Rhizoma Polygoni Cuspidati are ground into coarse powder, add ethanol extraction, and extracting solution concentrating under reduced pressure and Herba Leonuri alcohol deposit fluid merge, and are condensed into thick paste or dried cream powder, or the drug extract spray drying gets extract powder, mix with pharmaceutically acceptable carrier again.
Chinese medicine composition of the present invention can be made various common formulations together with its effective ingredient and/or pharmaceutically acceptable carrier, as powder, medicated wine, capsule, tablet, micropill, drop pill, oral liquid, granule etc.
Pharmaceutically acceptable carrier of the present invention includes but not limited to: excipient, as starch and derivant thereof, dextrin, calcium hydrogen phosphate, magnesium stearate, differential silica gel etc.; Disintegrating agent is as sodium carboxymethyl cellulose, hydroxypropyl cellulose etc.; Lubricant is as magnesium stearate etc.; The sugar coating material is as sucrose, Pulvis Talci, gelatin, pigment, river wax etc.; Thin film coating material is as stomach dissolution type water, pure coating material etc.
Chinese medicine composition of the present invention has blood circulation invigorating efficacies, can alleviate the hemorrhagic apoplexy cerebral edema, promote the reparation of absorption of hematoma and focus, improve the hypoxic-ischemic state of hematoma peripheral nerve tissue, the recovery of protection damage back brain cell, promotion patient nervous function, through acute toxicity testing, 4 multiple doses that add to optimum curative effect still do not have toxicity; Through clinical experiment, total effective rate reaches 82.5%, and life quality raising rate is 85%; Zoopery result and matched group have utmost point significant difference.
The specific embodiment
Following examples are used to illustrate the present invention, but are not used for limiting the scope of the invention.Embodiment 1: the preparation of powder of the present invention
Take by weighing following raw materials in weight: Herba Leonuri 1g, Rhizoma Polygoni Cuspidati 1g, Hirudo 18g, Cornu Bubali 1g, Radix Gentianae 19g.
Whole 80 ℃ of dryings of medical material join that coarse powder is broken into coarse grain in the pulverizer, and then it is ground into fine powder, cross 200 mesh sieves, and coarse grain was crushed to 200 mesh sieves again and gets final product
Embodiment 2: the preparation of medicated wine of the present invention
Take by weighing following raw materials in weight: Herba Leonuri 120g, Rhizoma Polygoni Cuspidati 120g, Hirudo 9g, Cornu rhinocerotis 12g, Radix Gentianae 9g.
All medical material cold drying are ground into fine powder, add 3 times of amount edible ethanols (50% ethanol) by weight, soak to get final product.
Embodiment 3: the preparation of capsule of the present invention
Take by weighing following raw materials in weight: Herba Leonuri 90g, Rhizoma Polygoni Cuspidati 10g, Hirudo 15g, Cornu Bubali 10g, Radix Gentianae 15g.
With Herba Leonuri extracting in water 2 hours, extracting solution is condensed into about 1: 1.5, precipitate with ethanol, alcohol precipitation concentration 60%, Cornu Bubali, Hirudo, Radix Gentianae, Rhizoma Polygoni Cuspidati are ground into coarse powder, add 70% ethanol extraction, extracting solution concentrating under reduced pressure and Herba Leonuri alcohol deposit fluid merge, and are condensed into thick paste, add starch, lactose, ethyl cellulose again, granulate, filling gets final product
Embodiment 4: the preparation of tablet of the present invention
Take by weighing following raw materials in weight: Herba Leonuri 10g, Rhizoma Polygoni Cuspidati 90g, Hirudo 3g, Cornu rhinocerotis 9g, Radix Gentianae 3g.
With Herba Leonuri extracting in water 3 hours, extracting solution is condensed into about 1: 1, precipitate with ethanol, alcohol precipitation concentration 45%, Cornu Bubali, Hirudo, Radix Gentianae, Rhizoma Polygoni Cuspidati are ground into coarse powder, add 45% ethanol extraction, extracting solution concentrating under reduced pressure and Herba Leonuri alcohol deposit fluid merge, and are condensed into thick paste, add starch, lactose, ethyl cellulose again, granulate, tabletting gets final product
Embodiment 5: the preparation of drop pill of the present invention
Take by weighing following raw materials in weight: Herba Leonuri 70g, Rhizoma Polygoni Cuspidati 20g, Hirudo 8g, Cornu Bubali 20g, Radix Gentianae 6g.
With Herba Leonuri extracting in water 1 hour, extracting solution was condensed into about 1: 2, precipitate with ethanol, alcohol precipitation concentration 30%, Cornu Bubali, Hirudo, Radix Gentianae, Rhizoma Polygoni Cuspidati are ground into coarse powder, add 95% ethanol extraction, and extracting solution concentrating under reduced pressure and Herba Leonuri alcohol deposit fluid merge, be condensed into thick paste, add mixing such as Polyethylene Glycol 4000 stearic acid again, water-bath makes the excipient dissolving, and is even with medicament mixed, the system of dripping gets final product, and coolant is a liquid paraffin.
Embodiment 6: the preparation of quick-release tablet of the present invention
Take by weighing following raw materials in weight: Herba Leonuri 40g, Rhizoma Polygoni Cuspidati 40g, Hirudo 4g, Cornu Bubali 40g, Radix Gentianae 12g.
With Herba Leonuri extracting in water 2 hours, extracting solution was condensed into about 1: 1.5, precipitate with ethanol, alcohol precipitation concentration 45%, Cornu Bubali, Hirudo, Radix Gentianae, Rhizoma Polygoni Cuspidati are ground into coarse powder, add 70% ethanol extraction, extracting solution concentrating under reduced pressure and Herba Leonuri alcohol deposit fluid merge, and are condensed into thick paste, add mixing such as Polyethylene Glycol 6000 stearic acid again, as waiting mixing, water-bath makes the excipient dissolving, and is even with medicament mixed, put the steel plate cooling, be ground into granule, add starch, lactose, hydroxypropyl cellulose, granulate, tabletting gets final product.
Embodiment 7: the preparation of quick-release capsules of the present invention
Take by weighing following raw materials in weight: Herba Leonuri 60g, Rhizoma Polygoni Cuspidati 30g, Hirudo 6g, Cornu Bubali 30g, Radix Gentianae 9g.
With Herba Leonuri extracting in water 2 hours, extracting solution was condensed into about 1: 1.5, precipitate with ethanol, alcohol precipitation concentration 45%, Cornu Bubali, Hirudo, Radix Gentianae, Rhizoma Polygoni Cuspidati are ground into coarse powder, add 70% ethanol extraction, extracting solution concentrating under reduced pressure and Herba Leonuri alcohol deposit fluid merge, and are condensed into thick paste, add mixing such as Polyethylene Glycol 6000 stearic acid again, as waiting mixing, water-bath makes the excipient dissolving, and is even with medicament mixed, put the steel plate cooling, be ground into granule, add starch and milk-sugar mixture, granulate, filling gets final product.
Embodiment 8: the preparation of microcapsule of the present invention
Take by weighing following raw materials in weight: Herba Leonuri 1g, Rhizoma Polygoni Cuspidati 60g, Hirudo 6g, Cornu rhinocerotis 0.1g, Radix Gentianae 9g.
With Herba Leonuri extracting in water 2 hours, extracting solution was condensed into about 1: 1.5, precipitate with ethanol, alcohol precipitation concentration 45%, Cornu Bubali, Hirudo, Radix Gentianae, Rhizoma Polygoni Cuspidati are ground into coarse powder, add 70% ethanol extraction, extracting solution concentrating under reduced pressure and Herba Leonuri alcohol deposit fluid merge, and are condensed into thick paste, and be standby.Get the mixture that ethyl cellulose adds dehydrated alcohol, ethyl acetate, acetone, warmly make dissolving, add drug extract, mix homogeneously under agitation joins in the aqueous solution, stirs down and volatilizes organic solvent, and filtration promptly.
Embodiment 9: the preparation of buccal tablet of the present invention
Take by weighing following raw materials in weight: Herba Leonuri 30g, Rhizoma Polygoni Cuspidati 30g, Hirudo 6g, Cornu Bubali 30g, Radix Gentianae 9g.
With Herba Leonuri extracting in water 3 hours, extracting solution was condensed into about 1: 1.5, precipitate with ethanol, alcohol precipitation concentration 45%, Cornu Bubali, Hirudo, Radix Gentianae, Rhizoma Polygoni Cuspidati are ground into coarse powder, add 70% ethanol extraction, extracting solution concentrating under reduced pressure and Herba Leonuri alcohol deposit fluid merge, and are condensed into thick paste, add Polyethylene Glycol 6000 again, stearic acid mixes, and water-bath makes the excipient dissolving, and is even with medicament mixed, put the steel plate cooling, be ground into granule, with Icing Sugar, granulate, tabletting gets final product.
Embodiment 10: preparation of soft capsule of the present invention
Take by weighing following raw materials in weight: Herba Leonuri 120g, Rhizoma Polygoni Cuspidati 120g, Hirudo 18g, Cornu Bubali 120g, Radix Gentianae 19g.
With Herba Leonuri extracting in water 2 hours, extracting solution was condensed into about 1: 1.5, precipitate with ethanol, alcohol precipitation concentration 45%, Cornu Bubali, Hirudo, Radix Gentianae, Rhizoma Polygoni Cuspidati are ground into coarse powder, add 70% ethanol extraction, and extracting solution concentrating under reduced pressure and Herba Leonuri alcohol deposit fluid merge, be condensed into thick paste, add Polyethylene Glycol 6000 again, stearic acid mixes, and gelatin is dissolved in water, add medicine, compacting gets final product.
Below set forth the effect of this Chinese medicine composition by test.
Experimental example 1 clinical research data
Method: patients with cerebral hemorrhage 404 examples, 24 examples that in 28 days, come off, low compliance 24 examples can be carried out therapeutic evaluation totally 356 examples.Diagnostic criteria:, all make a definite diagnosis with CT with reference to the 4th " all kinds of cerebral hemorrhage diagnostic point " that the cerebrovascular academic conference is passed through in the nineteen ninety-five whole nation; Include standard in: meet doctor trained in Western medicine " cerebral hemorrhage " diagnostic criteria, meet traditional Chinese medical science apoplexy standard, the onset time in 7 days, informed consent; Exclusion standard: merge serious cardiopulmonary Liver and kidney or various hematopathy, psychosis etc.
All cases are divided two kinds of methods, and matched group adopts western medical treatment, and experimental group uses medicine of the present invention, uses continuously 28 days.Followed up a case by regular visits to observing effect in 6 months.
Efficacy determination: mortality rate, degree of injury (divide pathology, sick damage, physical disabilities and can 4 levels of life obstacle).
The result: the experimental group total effective rate is 82.5%, and 72.5%, two group relatively there were significant differences for matched group; Aspect neurological functional recovery, quality of life raising and absorption of hematoma, the treatment group all obviously is better than matched group, and significant difference is remarkable.
Experimental example 2 experimentation data
Acute toxicity testing: 4 times of amounts according to clinical effective are given the rat perfusion, and animal activity is normal.
Long term toxicity test: according to clinical maximal dose administration 3 months, animal activity was normal, and biochemical indicator is not seen hepatorenal damage in normal range.
Pharmacodynamic experiment:
1, method: 60 of rats, male, body weight 200～250 grams, with 2% pentobarbital sodium 2.5ml/kg intraperitoneal injection of anesthesia, dorsal position is fixed on the stereotaxic instrument.Shave hair, routine disinfection, the about 0.8cm of scalp median incision, expose bregma, the other 2.9mm of 0.2mm center line place is with dental drill boring, with microsyringe (the about 0.7mm of syringe needle diameter) the edge boring inserting needle that is specified on the stereotaxic instrument, about deeply 6mm behind bregma, inject about 0.5u/ μ L collagenase VII-S Collagen Type VI enzyme induction rat cerebral hemorrhage mold, sew up.After reviving, animal marks grouping immediately.Matched group is the NIAOXUEKANG sheet, and experimental group gives medicine of the present invention.Administration after marking every day.Treat after 7 days and put to death, get brain, weigh, weigh after a part of drying, calculate moisture, another part section, microscopically observed result.
The result: compare with matched group, medicine of the present invention can significantly improve rat functional impairment classification (significant difference), can improve the cerebral hemorrhage rats cerebrovascular permeability, reduces brain water content, obviously improves the cerebral tissue ultrastructure.
2, animal and grouping; 40 of healthy adult SD rats, body weight 280g～360g.
The animal model preparation: rat is all through 10% chloral hydrate (300mg/kg) intraperitoneal injection of anesthesia, and is fixing in stereo brain orienting instrument.With reference to Paxinos G brain stereotactic collection of illustrative plates, in the about 10.0ram of scalp median incision, 1.3mm place boring behind the other 2.0mm of center line, bregma, A, B, C, E, F organize all with microsyringe from rat extracting blood 25pl, scalp is sewed up in the slowly withdraw of the needle after this puts vertical inserting needle 6.5mm to inject the capsula interna district.Postoperative is marked to nervous function, and scoring is included experiment in greater than 5 fens persons, and the model control group group replaces from body blood with normal saline 25 feet, the same experimental group of surplus operation.Be divided into 25 of brain arteries and veins treatment groups (A group), experiment contrast group on the 7th (E group) 14, be severe injury (scoring greater than 9 minutes) and account for 20%, moderate permanent disability (marking at 5～9 minutes) accounts for 80%.Female, male Mus half and half in each group, body weight are balanced substantially.
Scoring back successive administration 7 days, 1.4ml/100g (medicament contg is 1g/ml) carries out function of nervous system's scoring before administration every day, estimate recovery extent.
Evaluation methodology: scoring is reduced to moderate from severe, and reduces to from moderate and slightly to be judged to produce effects, and scoring reduces by 2 fens persons in same rank be effective.
The cerebral edema situation is observed, and rat is put to death in administration ends of mark after 7 days, gets brain, measures water content: use dried-weight in wet base method.Edema coefficient (%)=(weight in wet base-dry weight)/the weight of animals calculates the edema coefficient
Brain arteries and veins II effect experiment result
| Edema coefficient (g/kg) | To neurologic impairment influence (produce effects) | Effectively | Total effective rate % | |
| The administration group | 3.32 | 61.8 | 20.5 | 82.3 |
| Matched group | 4.63 | 15.8 | 23.5 | 39.3 |
The result: compare with matched group, medicine of the present invention can significantly improve rat functional impairment classification (significant difference), can improve the cerebral hemorrhage rats cerebrovascular permeability, reduces brain water content, obviously improves the cerebral tissue ultrastructure.
Claims (8)
1, a kind of Chinese medicine composition for the treatment of cerebral hemorrhage, it is made up of effective ingredient and/or pharmaceutically acceptable carrier, it is characterized in that its contained effective ingredient is to be made by the following weight proportion raw material: Herba Leonuri 1-120, Rhizoma Polygoni Cuspidati 1-120, Hirudo 1-18, Radix Gentianae 1-19, Cornu Bubali 1-120.
2, according to the described Chinese medicine composition of claim 1, wherein said effective ingredient weight ratio is: Herba Leonuri 10-90, Rhizoma Polygoni Cuspidati 10-90, Hirudo 3-15, Radix Gentianae 3-15, Cornu Bubali 10-90.
3, according to the described Chinese medicine composition of claim 1, wherein said effective ingredient weight ratio is: Herba Leonuri 40-70, Rhizoma Polygoni Cuspidati 20-40, Hirudo 4-8, Radix Gentianae 6-12, Cornu Bubali 20-40.
4, according to the described Chinese medicine composition of claim 1, it is characterized in that raw materials used Cornu Bubali can be a Cornu rhinocerotis in the effective ingredient, its consumption is 1/10 of a Cornu Bubali consumption.
5, according to the described Chinese medicine composition of claim 1, it is powder, medicated wine, capsule, tablet, micropill, drop pill, oral liquid, granule.
6, according to the preparation method of each described Chinese medicine composition of claim 1-5, it comprises described raw material of Chinese medicine directly is ground into fine powder, mixes again and/or with pharmaceutically acceptable carrier.
7, according to the preparation method of each described Chinese medicine composition of claim 1-5, it comprises described raw material of Chinese medicine directly is ground into coarse powder, adds ethanol extraction again and obtains, or continue to be condensed into dry extract, mixes again and/or with pharmaceutically acceptable carrier.
8, according to the preparation method of each described Chinese medicine composition of claim 1-5, it comprises that with the Herba Leonuri extracting in water extracting solution concentrates, precipitate with ethanol; Cornu Bubali, Hirudo, Radix Gentianae, Rhizoma Polygoni Cuspidati are ground into coarse powder, add ethanol extraction, and extracting solution concentrating under reduced pressure and Herba Leonuri alcohol deposit fluid merge, and are condensed into thick paste or dried cream powder, or the drug extract spray drying gets extract powder, mix with pharmaceutically acceptable carrier again.
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| CN102614270A (en) * | 2012-05-05 | 2012-08-01 | 钱家美 | Chinese medicine for treating cerebral hemorrhage and cerebral infarction diseases and sequelae thereof |
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| CN1059123C (en) * | 1998-10-22 | 2000-12-06 | 张继旭 | Medicine for treating brain apoplexy |
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| US9334239B2 (en) | 2012-12-21 | 2016-05-10 | Eisai R&D Management Co., Ltd. | Amorphous form of quinoline derivative, and method for producing same |
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