CN1663600B - Compound preparation composed of ginkgo leaf extracts and medicines promoting cerebral metabolism and its application - Google Patents
Compound preparation composed of ginkgo leaf extracts and medicines promoting cerebral metabolism and its application Download PDFInfo
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- CN1663600B CN1663600B CN200510005381A CN200510005381A CN1663600B CN 1663600 B CN1663600 B CN 1663600B CN 200510005381 A CN200510005381 A CN 200510005381A CN 200510005381 A CN200510005381 A CN 200510005381A CN 1663600 B CN1663600 B CN 1663600B
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- folium ginkgo
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Abstract
The invention relates to a compound preparation composed of ginkgo leaf extracts and medicines promoting cerebral metabolism and its application, wherein the medicinal preparation comprises one or more of ginkgo leaf extract, Piracetam, brain protein extract, Brevisca Pine and acceptable adjuvant. The preparation has the action of treating cerebrovascular deseases.
Description
Technical field:
The present invention relates to a kind of potentiation and treat cerebrovascular pharmaceutical preparation, this pharmaceutical preparation comprises one or more and the acceptable auxiliary in Folium Ginkgo extract and piracetam, brain protein extract, the breviscapine.
Background technology:
The Folium Ginkgo leaf extract has coronary artery dilator and cerebrovascular effect, can microcirculation improvement, promote the heart and brain tissues metabolism, and neurocyte is played a protective role.But this product is antagonism platelet activating factor (PAF) also, reduces platelet aggregation, improves hemorheology.Can also remove free radical and suppress the peroxidating of cell membrane lipid.Can make mitochondria respiratoring control rate obviously recover normal, cerebral edema alleviates, and the ion transport disorder obtains correcting, and shows normal function of nervous system index, and local ischemic rat brain is had significant protective effect.Be mainly used in the patient of brain, peripheral blood vessel and the cerebral ischemia of crown arteries obstacle, cerebral edema, comprise apoplexy, dementia, acute and chronic brain insufficiency and sequela, acute and chronic cerebral infarction etc.
Wherein promote the brain metabolic drug: comprise Cerebrolysin Vial, piracetam, breviscapine.
Wherein Cerebrolysin Vial pig brain tissue is through the compound protein enzyme hydrolysis, separate and refining and sterile preparation, contain about 16 kinds of free amino acid, and contain small amount of peptides.Can promote the formation of synapse to regulate and to improve neuronic metabolism, induce neuronic differentiation, the neuroprotective cell is avoided the infringement of various ischemias and neurotoxin, helps the reparation of nervous system cell.Can pass through blood brain barrier, promote the synthetic of brain internal protein, influence respiratory chain, have the protective capability of anti-hypoxia, improve the metabolism of brain self-energy, have the effect of similar nerve growth factor.
Piracetam is the derivant of γ-An Jidingsuan; be a kind of novel short thinking memory medicine, easily can directly act on cerebral cortex, promote brain phospholipid and amino acid whose utilization by blood brain barrier; increase brain to proteinic synthetic, the effect that have protection, activates and repair neurocyte.Can make the ADP in the brain be converted into ATP, improve brain intracellular metabolite energy supply situation.Influence the excited transmission of cholinergic neuron, promote acetylcholine synthetic.Can resist the injury of brain function due to physical factor and the chemical factor, quicken between cerebral hemisphere to improve one's memory, strengthen of the control of brain cortex neuromechanism under the cortex through callosal information transmission.Reduce cerebral vascular resistance, blood flow increasing and improve cerebral circulation improves study, memory and memory ability.
Breviscapine is the flavones ingredient that extracts from Herba Erigerontis Herb plant, is the protein kinase depressant.Can improve brain microcirculation, the cerebral blood flow increasing amount.Increase periphery, arteria coronaria and myocardial flow, anticoagulant significantly reduces the activity of neutrophilic granulocyte myeloperoxidase (MPO), and the adhesion that reduces neutrophilic granulocyte in the ischemic tissue of brain is soaked into, the protection ischemic tissue of brain.Strengthen fibrinolytic, the lipoprotein metabolism that can suppress the ischemic cerebrovascular patient effectively reaches high viscous blood pressure unusually.
By Folium Ginkgo leaf extract and the compound preparation that promotes that the brain metabolic drug is formed; the two has synergism; not only can microcirculation improvement, blood flow increasing is removed free radical and is suppressed the peroxidating of cell membrane lipid; cerebral edema alleviates; local ischemic rat brain is had significant protective effect, can also see through blood brain barrier, promote the neurocyte reparation; improve the nerve injury function, the generation of the somatomedin that excites nerve.Has multiple efficacies, be used for the treatment of the disease that brain, peripheral blood vessel and crown arteries obstacle cause, comprising apoplexy, dementia, acute and chronic brain insufficiency and sequela thereof, neurosis, incomplete brain blood supply, acute and chronic cerebral infarction, aging, cerebrovascular accident, cerebral trauma, vertigo, cerebral edema, the CO memory that causes and light, coronary heart disease, angina pectoris, moderate disordered brain function etc. such as poison, is an excellent drug prescription.
Summary of the invention:
The invention provides a kind of compound preparation of brain metabolic drug, said preparation contains the Folium Ginkgo extract and the metabolic medicine of at least a promotion brain of effective dose.Wherein short brain metabolic drug is selected from: piracetam, Cerebrolysin Vial or breviscapine.
Pharmaceutical preparation of the present invention, in the preparation of per unit dosage, contain Folium Ginkgo extract 10～200mg, the metabolic medicine of promotion brain that contains is different and different according to medicine, for piracetam is 100～20000mg, for Cerebrolysin Vial is 1～900mg, is 1～200mg for breviscapine.
Pharmaceutical preparation of the present invention, in the preparation of per unit dosage, contain Folium Ginkgo extract 10～100mg, the metabolic medicine of promotion brain that contains is different and different according to medicine, for piracetam is 100～15000mg, for Cerebrolysin Vial is 45～450mg, is 1～100mg for breviscapine.
Pharmaceutical preparation of the present invention, in the preparation of per unit dosage, contain Folium Ginkgo extract 10～80mg, the metabolic medicine of promotion brain that contains is different and different according to medicine, for piracetam is 200～10000mg, for Cerebrolysin Vial is 90～360mg, is 10～60mg for breviscapine.
Particularly preferably be in the preparation of per unit dosage, contain the pharmaceutical preparation of Folium Ginkgo extract 5～40mg and piracetam 2000～3000mg.Contain the pharmaceutical preparation of Folium Ginkgo extract 5～40mg and Cerebrolysin Vial 5～50mg.Contain the pharmaceutical preparation that Folium Ginkgo extract 5～40mg and breviscapine are 2～20mg.
The preparation of per unit dosage of the present invention refers to, the final drug preparation of per unit is as every of injection, every, capsular every of tablet etc.
Pharmaceutical preparation of the present invention, can be any pharmaceutical dosage forms, preferably: tablet, capsule, enteric coatel tablets, enteric coated capsule, soft capsule, slow releasing tablet, slow releasing capsule, controlled release tablet, controlled release capsule, powder, oral cavity disintegration tablet, drop pill, injection, lyophilized powder, aseptic powder, glucose sugar injection or sodium chloride injection.
The present invention also provides the disease of pharmaceutical preparation of the present invention in that preparation treatment brain, peripheral blood vessel and crown arteries obstacle cause, comprises apoplexy, dementia, acute and chronic brain insufficiency and sequela thereof, neurosis, incomplete brain blood supply, acute and chronic cerebral infarction, aging, cerebrovascular accident, cerebral trauma, vertigo, cerebral edema, CO application in the medicine of the memory that causes and light, coronary heart disease, angina pectoris, moderate disordered brain function disease such as poison.
Brain metabolic drug preparation provided by the invention also can contain the medicine acceptable auxiliary.These adjuvants comprise: filler, binding agent, disintegrating agent, lubricant.
Filler can be selected in the pharmaceutical preparation: starch, calcium phosphate, calcium phosphate, calcium sulfate two water things, dextrin, microcrystalline Cellulose, lactose, mannitol etc.Preferably: starch, microcrystalline Cellulose, lactose.
Binding agent can be selected in the preparation: PVP-K30, hydroxypropyl cellulose, starch slurry, ethyl cellulose, hypromellose, gelling starch etc.Preferably: PVP-K30, starch slurry.
Disintegrating agent can be selected in the preparation: polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose etc.Preferably: polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose.
Lubricant can be selected in the preparation: magnesium stearate, Pulvis Talci, sodium lauryl sulphate, micropowder silica gel etc.
The invention is characterized in that pharmaceutical preparation can be made into injection.This injection comprises one or more and the acceptable auxiliary in active constituents of medicine Folium Ginkgo extract and piracetam, brain protein extract, the breviscapine.These adjuvants comprise: solubilizing agent, pH value regulator, filler.Wherein solubilizing agent comprises: propylene glycol, glycerol, ethanol, Polyethylene Glycol etc.
Filler can be selected: mannitol, aqueous gelatin, sodium chloride, glucose, glycine etc.
Preparation method of the present invention is simple, does not need special installation, can be fit to large-scale production according to the operation of galenic pharmacy routine techniques method.
Following data declaration beneficial effect of the present invention by experiment:
Drug synergism
In order to prove that the two has synergism, the clinical research that we have organized one 124 people to participate in, all selected patients are cerebral infarction, wherein acute stages 48 example, convalescent periods 56 example, sequela stage 20 examples.The elder of the course of disease is 8 years, and the patient is made the head door and MM checks, cerebral malacia or brain atrophy is in various degree all arranged, and make mensuration such as hematuria stool routine, liver function, blood fat, whole blood contrast viscosity, Fibrinogen, erythrocyte sedimentation rate.Being divided into three groups at random is compound folium ginkgo leaf Cerebrolysin Vial preparation for treating group 42 examples, and 41 examples are organized in the treatment of the simple Folium Ginkgo leaf of control group A, simple brain protein groups 41 examples of matched group B.Wherein treatment group gives 5%CS 250ml+ Cerebrolysin Vial 10ml+ Folium Ginkgo leaf extract 10ml, ivgtt, and qd, 14 days is a course of treatment; Control group A: 5% CS 250ml Folium Ginkgo leaf extract 10ml, ivgtt, qd, 14 days is a course of treatment; Matched group B 5%CS 250ml brain protein 10 ml, ivgtt, qd, 14 days is a course of treatment; Carry out the simple intelligent test before and after the medication, dysnoesia, aphasis degree and hemiplegia degree detect and assessment with the simple and easy intelligence scale in international standard Chang Gu river.
After treating back 14 days, treatment group and matched group clinical symptoms are improved effective percentage relatively, see Table 1.Treatment group produce effects 23 examples, effective 11 examples, 8 examples are invalid, total effective rate reach 81% wherein after the 23 routine mental retardation person medications muscular strength improve above person's 10 examples of II level, feel limb adynamia after the 3 routine medications, the no significant change of 1 example is more than 22 illustrative phrases speech obstacle person, the 18 routine raising I levels.
Table 1 compound preparation group is to the influence of neurological deficits score
Degree of improvement=(before the treatment-the treatment back)/before treating
Table 2 compound preparation group is to hemorheological influence (X ± S)
By table 1, as can be seen, compound preparation group neurologic impairment improves than control group A, B than obviously in 2, and rank test has significant difference; And treatment back compound preparation group cuts with respect to two matched group whole blood height that viscosity, whole blood are low cuts viscosity and the hematocrit significance reduces, and has statistical significance.The two can increase mutual curative effect to disclose Cerebrolysin Vial and Folium Ginkgo extract, not only can improve function of nervous system, but also have antiplatelet effects, and the two has synergism.
We have collected cerebral infarction patient 42 examples of in January, 2003～2004 between year May again, turn out to be acute non-hemorrhagic Cerebral Infarction through CT or MRI, no liver, kidney, the heart, lung severe complication, do not have stupor, all patients are divided into compound breviscapine gingko leaf preparation group and simple Folium Ginkgo extract matched group according to the order of being admitted to hospital at random.The compound preparation group gives breviscapine Folium Ginkgo 6/30ml/d, qd, ivgtt.Simple Folium Ginkgo matched group gives Folium Ginkgo extract 30ml/d, qd, and ivgtt, 25 days was 1 course of treatment.Observation index is mainly neurological deficits score, blood pressure, hemorheology, blood fat, blood glucose etc.These indexs are individual mensuration once before treatment and after finishing, and estimates curative effect and toxic and side effects according to twice measurement result.Result such as following table 3,4:
Table 3 compound preparation group is to the influence of neurological deficits score
Degree of improvement=(before the treatment-the treatment back)/before treating
Table 4 compound preparation group and matched group are to hemorheological influence
*P＜0.05
As can be seen from Table 3, compound breviscapine gingko leaf preparation group function of nervous system improves obvious than matched group, and the two is compared has significant difference.And show in the table 4: compound preparation group treatment back whole blood height is cut viscosity, whole blood hangs down and cuts viscosity and the reduction of hematocrit significance, discloses the compound preparation group and has the effect of the blood viscosity of reduction.Compound preparation group treatment back platelet adherence rate significantly descends, and prompting has antiplatelet effects.The compound preparation of expression breviscapine and the two composition of Folium Ginkgo leaf extract, better efficacy can increase clinical efficacy each other, and the two has synergism.
Be administered once every day and be used for the treatment of the disease that brain, peripheral blood vessel and crown arteries obstacle cause, comprising apoplexy, dementia, acute and chronic brain insufficiency and sequela thereof, neurosis, incomplete brain blood supply, acute and chronic cerebral infarction, aging, cerebrovascular accident, cerebral trauma, vertigo, cerebral edema, the CO memory that causes and light, coronary heart disease, angina pectoris, moderate disordered brain function etc. such as poison, is an excellent drug prescription.
Dosage and administration: as for oral, adult's usual amounts: starting dose is I, II side, reaches therapeutic effect as 2 Zhou Houwei, rises to III and IV.Once a day, tuxedo is used.Dosage can be adjusted as required.
Compound preparation provided by the invention in the ejection preparation unit dose, comprises 5～40mg Folium Ginkgo extract and the piracetam of 800～3000mg or the breviscapine of 5～90mg Cerebrolysin Vial or 1～5mg of effective dose.
(oral)
(injection)
The specific embodiment:
Further specify the present invention by the following examples.
Embodiment 1: preparation Folium Ginkgo extract+piracetam thin membrane coated tablet
Prescription: 1000
Folium Ginkgo extract 20g
Piracetam 400g
Starch 25g
PVP-K30 (10% aqueous solution) 12g
Microcrystalline Cellulose 66g
Low-substituted hydroxypropyl cellulose 24g
Magnesium stearate 3g
Preparation method: take by weighing recipe quantity Folium Ginkgo extract, piracetam, starch, low-substituted hydroxypropyl cellulose (2/3) with 10% PVP-K30 aqueous solution system soft material, cross 20 mesh sieves, 60 ℃ of dryings, 18 mesh sieve granulate add microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate direct compression.The ordinary tablet that makes is done the sheet heart, and film coating promptly.
Embodiment 2: preparation Folium Ginkgo extract+brain protein extract Film coated tablets
Prescription: 1,000 1000
Folium Ginkgo extract 40g brain protein extract 180g
Starch 50g lactose 60g
Dextrin 25g 3% hydroxypropyl cellulose aqueous solution is an amount of
8% starch slurry 5g microcrystalline Cellulose 50g
Polyvinylpolypyrrolidone 18g
Magnesium stearate 2g
Preparation method: Folium Ginkgo extract and brain protein extract are granulated respectively.Folium Ginkgo extract, starch, dextrin with 8% starch slurry system soft material, are crossed 20 mesh sieves and granulated, 60 ℃ of dryings, 18 order granulate.Take by weighing brain protein extract, lactose with 3% hydroxypropyl cellulose aqueous solution system soft material, cross 20 mesh sieves and granulate, 40 ℃ of dryings, 18 mesh sieve granulate.After Folium Ginkgo extract granule and brain protein extract granule mix homogeneously added microcrystalline Cellulose, polyvinylpolypyrrolidone, magnesium stearate mix homogeneously, direct powder compression.
The ordinary tablet that makes is done the sheet heart, and the bag film-coat promptly.
Embodiment 3: preparation Folium Ginkgo extract+breviscapine ordinary tablet
Prescription: 1000
Folium Ginkgo extract 40g
Breviscapine 20g
Starch 51.7g
Dextrin 25g
8%PVP-K30 alcoholic solution 5g
Cross-linking sodium carboxymethyl cellulose 6g
Magnesium stearate 0.8g
Micropowder silica gel 1.5g
Preparation method: take by weighing the 50% alcoholic solution system soft material of recipe quantity Folium Ginkgo extract, breviscapine, starch, dextrin, cross-linking sodium carboxymethyl cellulose (2/3) usefulness 8%PVP-K30, cross 20 mesh sieves and granulate 60 ℃ of dryings, 18 mesh sieve granulate.Add magnesium stearate, micropowder silica gel direct compression promptly.
Embodiment 4: preparation Folium Ginkgo extract+piracetam oral solutin
Prescription: 1000ml
Folium Ginkgo extract 4g
Piracetam 40g
Citric acid 0.2g
Malic acid 0.6g
Sodium benzoate 1.5g
60% simple syrup 300ml
Distilled water adds to 1000ml
Preparation method: take by weighing about 500ml distilled water and under constantly stirring, add Folium Ginkgo extract, piracetam, stir and add citric acid, malic acid, sodium benzoate, after the stirring and dissolving, add 60% simple syrup 300ml, measure pH value (pH value is controlled between 5.5～6.5), filter, distilled water diluting is to capacity, every bottle of 10ml of fill sterilized 30 minutes, and got product for 100 ℃.
Embodiment 5: Folium Ginkgo extract+brain protein extract oral liquid
Prescription: 1000ml
Folium Ginkgo extract 2g
Brain protein extract 90g
Tween 80 0.5g
2% ethyl hydroxybenzoate alcoholic solution 10ml
Sodium benzoate 1.5g
Sucrose 100g
0.1mol/L sodium hydroxide solution is an amount of
Distilled water adds to 1000ml
Preparation method: tween 80 is dissolved in an amount of distilled water, stir and add Folium Ginkgo extract, brain protein extract, sodium benzoate, sucrose, 2% ethyl hydroxybenzoate alcohol stirring and dissolving, add an amount of sodium hydroxide and regulate pH value (the control pH value is between 7.0～7.5), adding distil water is to capacity, fill (every bottle of 10ml), 100 ℃, sterilization in 30 minutes, promptly.
Embodiment 6: preparation Folium Ginkgo extract+brain protein extract freeze-dried product
Prescription: 5000ml
Folium Ginkgo extract 20g
Brain protein extract 70g
Gelatin hydrolysate 50g
Mannitol 100g
20% sodium hydroxide solution is an amount of
Water for injection adds to 5000ml
Preparation method: take by weighing recipe quantity Folium Ginkgo extract, brain protein extract and stir to add in the 4000ml water for injection and add gelatin hydrolysate, mannitol after the stirring and dissolving, regulate pH value between 5.0～7.0 with 20% sodium hydroxide solution, add distilled water to capacity, stir evenly, packing (every bottle of 5ml), lyophilization promptly.
Claims (3)
1. a pharmaceutical preparation for the treatment of cerebrovascular is characterized in that, in the preparation of per unit dosage, contains Folium Ginkgo extract 10～80mg, contains Cerebrolysin Vial 90～360mg.
2. the pharmaceutical preparation of claim 1 is selected from: tablet, capsule, powder, drop pill, injection, lyophilized powder or aseptic powder.
3. the pharmaceutical preparation of claim 1 is in the disease that preparation treatment brain, peripheral blood vessel and crown arteries obstacle cause, comprises the application in the medicine of apoplexy, dementia, acute and chronic brain insufficiency and sequela thereof, neurosis, incomplete brain blood supply, acute and chronic cerebral infarction, aging, cerebral trauma, vertigo, cerebral edema, coronary heart disease, angina pectoris, moderate disordered brain function disease.
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| CN1546063A (en) * | 2003-12-05 | 2004-11-17 | 吉林省辽源亚东药业股份有限公司 | Encephalic proteolytic products of compound Piracetam and its preparation |
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