CN1236766C - Natural composite preparation for protecting and improving cerebral and heart function and its preparation method - Google Patents

Natural composite preparation for protecting and improving cerebral and heart function and its preparation method Download PDF

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CN1236766C
CN1236766C CN 200410001133 CN200410001133A CN1236766C CN 1236766 C CN1236766 C CN 1236766C CN 200410001133 CN200410001133 CN 200410001133 CN 200410001133 A CN200410001133 A CN 200410001133A CN 1236766 C CN1236766 C CN 1236766C
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extract
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tanshinone
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CN1557307A (en
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任连坤
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Abstract

The present invention discloses a purely natural compound preparation for protecting and improving a cardio-cerebral function. The effective components of the present invention are composed of a gingko leaf extract, a red sage root extract and huperzia serrata extract, wherein the effective components of the gingko leaf extract are ginkgetin and ginkalide, and 6 mg of ginkgetin and 1.5 mg of ginkalide are contained in per unit of the preparation; the effective components of the red sage root extract are tanshinone I, tanshinone II A, cryptotanshinone and tanshinol, and by taking the content of the tanshinone II A as an assessment index, 0.2 mg is contained in per unit of the preparation; the effective component of the huperzia serrata extract is huperzine A, and 50 mu g of the huperzine A is contained in per unit of the preparation. The present invention belongs to the field of health food and relevant fields. The present invention has the advantages that optimum compatibility is carried out aiming at a plurality of mechanisms, which is harmonious and consistent, the limitation of components of a single group is broken, the ability of improving cardio-cerebral blood supply and an antioxidant ability are wholly provided, the structures of blood vessel endothelium, nerve cells, etc. are protected, and the information transmission of synapsing relation between neurons is enhanced.

Description

A kind of pure natural oral formulations of protecting and improving cardio cerebral function and preparation method thereof
Technical field
The present invention relates to a kind of pure natural oral formulations of protecting and improving cardio cerebral function and preparation method thereof, refer to a kind of heart and brain of improvement blood supply that has especially; Remove oxidant, protection brain cell and blood vessel; Strengthen between the neuron and get in touch, improve the preparation method of pure natural compound formulation, its dosage form and this pure natural compound formulation of cognitive function, belong to health food and association area.
Background technology
In current society, the aged's quick increase has data to show, China more than 60 years old population reached 1.2 hundred million as far back as 1998, and, be much higher than the rate of population increase with average annual 3.2% speed increase, middle period next century can reach about 400,000,000, will become the maximum country of the aged in the world.Heart and brain are the most important organs of human body, and going down of heart and brain function appears in middle-aged and elderly people, exist to be easy to problems such as fatigue, energy decline, hypomnesis, and are faced with coronary heart disease occurred frequently, myocardial infarction, apoplexy and dull-witted threat.Therefore, there is an urgent demand of protecting brain, slow down aging to nourishing heart in entire society.
The key of keeping cardio cerebral function is to ensure the energy supply of heart and brain, the interaction that alleviates deleterious damage and increase neurotransmitter between the neuron.
1) sclerosis of blood vessel, narrow be the main cause that causes serious diseases such as cardiovascular and cerebrovascular vessel.The activity of heart and brain nervous cell, extremely active, need lot of energy to supply with.Middle-aged and elderly people is because the heart, cerebrovascular atherosclerosis, the angiostenosis that some has weight not wait, thus cause heart and blood supply in brain, oxygen supply deficiency.Microcirculation improvement and protection vascular endothelial cell are the important means that ensures blood supply.
2) toxic action of peroxide.In histiocytic metabolic activity process, produce peroxide, because going down of middle-aged and elderly people organ dysfunction, the ability of removing peroxide goes down, the accumulation of peroxide can cause histiocytic damage, as damage, the necrosis of vascular endothelial cell, neuronal cell and myocardial cell membrane.The complete of cell membrane is the effectively active basis of performance of cell.Human myocardium's cell and neuron are subjected to the infringement of free radical for a long time, are to cause old and feeble main cause.
3) neurotransmitter levels descends.Get in touch by synapse between the neuron, thus input, integration and the output of performance information, and this also is that cognitive informatics is explained.And neurotransmitter, be active between synapse " courier ", acetylcholine (ACh) is as a kind of neurotransmitter, have different types, extensively be present in the central nervous system peripheral nervous system of unifying, have presynaptic membrane to discharge, act on postsynaptic membrane, transmission information plays a part key, the loss of activity by acetylcholinesterase (AChE) metabolism of synaptic space.A large amount of basic test and clinical observations show, neuronal nicotinic type acetylcholine and attention, memory, learning capacity, and other cognitive process relevant.It is the key of hypophrenia that the nervous system type acetylcholine that middle-aged and elderly people occurs reduces, and the decline of going down with acetylcholine function of nervous system of learning and memory ability has direct relation.
Had on the domestic and international market at present a lot of nourish heart, the product of brain boosting and supplementing, but the overwhelming majority exists curative effect unreliable, perhaps acts on single defective.Product main component in the market can be divided into several big classes: 1) pure Chinese patent medicine class (gingko leaf preparation, Radix Et Caulis Acanthopanacis Senticosi preparation, gastrodia tuber preparation etc.), and as ANSHEN BUNAO YE, brain-invigorating capsule, nourishing brain pill etc., composition is single, and effect is limited; 2) simple oxygenating class, upright as oxygen.Nutrition class (lecithin, cephalin, bathypelagic fish wet goods) as various fish oil goods etc., acts on singlely, and effect is little; 3) melatonin class (its chemical name is Mei Letongning), as melatonin etc., present medical research has very big dispute for its effect.
Summary of the invention
The objective of the invention is to utilize the modern medicine new development, suitable compatible combination, collaborative playing a role, provide one can be comprehensive at the protection of a plurality of links with improve cardio cerebral function, improve cognitive function, thereby play the pure natural compound formulation of slow down aging.
Another object of the present invention is to provide the preparation method of this pure natural preparation.
For achieving the above object, the present invention is by the following technical solutions:
A kind of pure natural compound formulation of protecting and improving cardio cerebral function, its effective ingredient is made up of Folium Ginkgo extract, Huperziaserrata extract and Radix Salviae Miltiorrhizae extract, wherein:
The per unit dosage form contains Folium Ginkgo extract 25mg, and effective ingredient is ginkgetin, bilobalide (terpene lactones), and content is ginkgetin 6mg, bilobalide 1.5mg;
The per unit dosage form contains Huperziaserrata extract 0.5mg, and effective ingredient is a huperzine A, and content is 50 μ g;
The per unit dosage form contains Radix Salviae Miltiorrhizae extract 2mg, and effective ingredient is Tanshinone I, tanshinone, cryptotanshinone and danshensu, is the content evaluation index with the tanshinone, and content is 0.2mg;
Reasonable recipe of the present invention, definite effect, remarkable can be protected and improve cardio cerebral function, improve cognitive competence.Existing being explained as follows to each effective ingredient:
1) Radix Salviae Miltiorrhizae extract: at the energy supply of heart and brain, improve the heart and brain circulation, activating blood circulation to dissipate blood stasis is the strong point of traditional medicine.In China, for the applicating history of Radix Salviae Miltiorrhizae for a long time, be widely used in the field of cardiovascular and cerebrovascular disease, effect is sure.The application modern technology is found, mainly contain liposoluble constituent diterpene quinones meeting thing (Tanshinone I, tanshinone, cryptotanshinone etc.) and water soluble ingredient danshensu etc. in the Radix Salviae Miltiorrhizae extract, the following effect of the performance that can coordinate: (1) improves hemodynamics: this product can be expanded the feeding artery of brain, coronary artery dilating, thereby increase the blood confession of heart and brain, further improve its function.(2) microcirculation improvement: the microcirculation to cerebral tissue improves significantly, and also can improve the periphery microcirculation disturbance.(3) improve hemorheology: can improve the activity of cellulase, promote fibrinolysis, can improve whole blood viscosity and plasma viscosity and reduce.
2) Huperziaserrata extract: traditional Chinese herbal medicine Herba Lycopodii serrati, be commonly called as Herba Lycopodii serrati, since the eighties, chemistry and pharmacological action to Herba Lycopodii serrati both at home and abroad studies in great detail, the effective ingredient huperzine A that confirmation is extracted from Herba Lycopodii serrati, it is a kind of selectivity AChE inhibitor, can suppress to reversibility the nervous system type acetylcholinesterase between the synapse, thereby indirect raising nervous system type levels of acetylcholine, accelerate the contact between the neuron, and long action time, avirulence.If animal experiment shows that huperzine A can significantly improve the study of animal, memory is consolidated and the memory represents effect, reverses anoxia, galvanic shock, eastern Liang the dysmnesia that alkali treatment causes.The pharmacology of huperzine A and clinical research confirmation, the like product of preventing and treating the slow-witted disease of presenile disease that it is better than developing in recent years in the world.Clinical trial observe to show (at random, double blinding, placebo), and the curative effect height does not have tangible ill effect.For the adolescence crowd, can improve school grade.
3) Folium Ginkgo extract: Semen Ginkgo belongs to Ginkgoaceae Ginkgo Semen Ginkgo kind deciduous tree, rare tree species.The therapeutical effect beginning of Folium Ginkgo sees " legendary god of farming's book on Chinese herbal medicine " and " the product remittance is smart to be wanted ".Modern pharmacology and clinical and experimental study prove, the main effective ingredient of Folium Ginkgo extract is ginkgetin and bilobalide (terpene lactones), its major physiological effect is: 1) anti-oxidation function: the generation that Folium Ginkgo is removed free radical through clinical confirmation, suppress the snperoxiaized function of cell membrane lipid.Human brain and neurocyte are subjected to the infringement of free radical for a long time, are to cause old and feeble main cause.Folium Ginkgo can be protected the fatty ingredient of human body cell film, and then the destruction of reducing external oxygen-derived free radicals, slow down aging.The elaborative faculty and the memory of taking the adult men and women of Folium Ginkgo have obvious improvement.2) vascular protection function: according to the study, Folium Ginkgo can be regulated the tension force and the elasticity of blood vessel, and the protection vascular endothelial cell is avoided infringement.So Folium Ginkgo can be used for administering coronary atherosclerotic heart disease, hypertension and angina pectoris.In addition, Folium Ginkgo can promote the blood circulation of periphery, and the blood circulation that the old people is often suffered from brothers reduces, and causes that through regular meeting ice-cold, the numb situation of trick is helpful.3) in addition, current research is found: Folium Ginkgo extract has the valuable pharmacological effect that activates cerebral neuron, so the effect of directly improving memory and cognitive competence is arranged.According to animal experiment and clinical observation, an amount of use Folium Ginkgo does not have serious adverse effects.
The pure natural compound formulation of enhancing cardio cerebral function provided by the invention, improvement cognition, slow down aging, on the basis of above-mentioned effective ingredient, add galenic pharmacy acceptable auxiliary (being selected from starch, dextrin, cane sugar powder, essence, magnesium carbonate and magnesium stearate), make various peroral dosage forms, for example capsule, oral liquid, electuary and tablet etc.
A kind of preparation method of protecting and improving the pure natural compound formulation of cardio cerebral function may further comprise the steps: 1) get the raw materials ready: according to above-mentioned ratio each effective ingredient of ormal weight is added appropriate amount of auxiliary materials, abundant mixing; 2) granulate; 3) oven dry; 4) sterilization; 5) packing gets final product.
Chinese herbal medicine is the rarity of China's traditional medicine, uses the modern medicine means its research has been caused the attention of countries in the world, and obtained very big progress, and the present invention makes full use of the reliable achievement of modern medicine forward position research, protects and improves cardio cerebral function.Creativeness of the present invention is the innovation of compatibility, at a plurality of mechanism, optimum compatibility, harmonious, can be comprehensively from the many aspects supplementing the brain that nourishes heart.The omnibearing information transmission that the structure of improving cardiac and cerebral blood-supply, stabilizing tissue cell is provided, strengthens the synaptic contact between the neuron.Raw material of the present invention all comes from natural extract, and basic research and clinical practice confirm there is not obvious toxic and side effects, do not have the taboo of compatibility between each composition, do not have mutual ill effect.More than each extract all have edible and medicinal attribute, and China's Ministry of Public Health and drugs approved by FDA can be used as food additive and use.
The invention has the beneficial effects as follows: 1) improve hemodynamics: can expand the feeding artery of heart and brain, coronary artery dilating, thus the blood confession of increase heart and brain further improves its function.2) microcirculation improvement: can improve the microcirculation of heart and brain tissues, and the periphery microcirculation disturbance is also improved significantly.3) remove peroxide, stablize the structure of neurocyte and blood vessel endothelium.6) increase getting in touch between neuron and the synapse, thereby can protect and improve cardio cerebral function all sidedly.
The invention will be further described below in conjunction with the specific embodiment, and the replacement that is equal to of all this areas of doing according to content disclosed by the invention all belongs to protection scope of the present invention.
The specific embodiment
Embodiment 1, a kind of capsule of protecting and improving cardio cerebral function
To produce 1000 capsule is example, and raw material is commercially available, and its active constituent content meets abides by Chinese Pharmacopoeia requirement in 2000, and carries out according to Chinese Pharmacopoeia standard in 2000:
One, preparation method:
Radix Salviae Miltiorrhizae extract 2g (containing Tanshinone I, tanshinone, cryptotanshinone, danshensu, is the content evaluation index with the tanshinone, and content is 10%, the HPLC method); Huperziaserrata extract 0.5g (huperzine A content 10%, HPLC method); Folium Ginkgo extract 25g (flavonoid of ginkgo biloba is 24%, and terpene lactones is 6%, the HPLC method); Add an amount of distilled water, starch mixing (can drop into abundant mixing in the blender); Granulate; Oven dry; Encapsulated behind the high temperature sterilize.
Two, specification: the per unit dosage form contains effective composition: it is 0.2mg that the per unit dosage form contains tanshinone; Huperzine A 50 μ g; Ginkgetin 6mg, terpene lactones 1.5mg.
Three, be suitable for the crowd:
This prescription is applicable to mid-aged population.
The careful usefulness of bleeding tendency person is arranged.
Instructions of taking: every day, the 1-2 unit formulation was taken.
Embodiment 2, clinical observation
One, research purpose: observe the effect that the present invention protected and improved cardio cerebral function.
Two, materials and methods
1, subjects: the object of observation has 38 people, minimum 46 years old of age, maximum 75 years old, male 21 people, women 17 people.Purpose to this observation is carried out man-to-man detailed explanation to the experimenter, adopts the principle of voluntariness.
2, include standard in: (1) has the performance or the main suit of forgetful, dizzy, dizzy, uncomfortable in chest, fatigue and weakness, absent minded, readme energy decline.(2) no various organic, metabolic, poisoning disease and depression.(3) tried the previous moon and do not taken the other types nutrient drug.
3, test method: be own control research before and after the test.
4, medication: take sample (this observation adopt capsule formulation), usage is every day 1 time, and each 1,30 days courses of treatment.
4, content measurement:
4,1 cardiac function evaluation: all go Electrocardioscopy before and after being tried, tried the obvious performance that preceding 22 examples have dizziness, uncomfortable in chest and lassitude, and electrocardiogram presents ischemic ST and changes.Criterion of therapeutical effect: cure (symptom all disappears, and Electrocardioscopy is roughly normal); Produce effects (symptom is more preceding obviously to be alleviated, and Electrocardioscopy is roughly normal or more preceding obviously to alleviate); Progressive (symptom before alleviates, more preceding improvement of Electrocardioscopy or no change); Invalid (the more preceding nothing of symptom is improved the more preceding no change of Electrocardioscopy).
4, the evaluation of 2 brain functions: (Wechsler memory scale WMS), is divided into first, second two formulas to the Wechsler Memory Scale of revisions such as the employing Gong Yao of Hunan Medical University elder generation, and WMS first formula and second formula are adopted in detection respectively before and after the treatment.Mainly comprise the test of (1) long term memory: personal story, about time, spatial orientation, the numerical order relation; (2) short term memory test: vision is re-recognized, picture is recalled, vision regeneration, learning by association, touch test, understand and remember; (3) immediate memory test: along the back of the body and the back of the body numeral of falling.Observing time and inspection intervals 1 month check that the overall performane result is MQ, and MQ is high more, and the expression memory function is good more.Test has trained neurosurgeon to finish.
Simultaneously, if uncomfortable reaction has been set up the mode of contact at any time, and has been given itemized record.
5, statistical method: adopt own control to analyze, all data are all with self paired t-test analysis.
Three, result
Finish experimenter 38 people.Have no adverse reaction.
1, cardiac function evaluation (observation that 22 examples are had the performance of obvious myocardial ischemia and exist ischemic ST to change): cure: 3 examples (14%); Produce effects 6 examples (27%); Progressive 8 examples (36%); Invalid 5 examples (23%).Total effective rate: 77%.
2, the WMS scoring shows that subtest scale score and memory quotient (MQ) are significantly increased by (table 2), have statistical significance before and after the test.n=38
Project Before the test After the test Difference The P value
1 → 100 recalls vision along several 100 → 1 numeral accumulation pictures reciprocal re-recognizes vision regeneration associative learning 7.42±2.67 12.14±2.69 11.46±3.42 10.41±2.02 10.11±2.60 9.77±2.41 10.99±2.41 11.02±2.43 13.74±2.55 11.82±2.46 14.43±1.54 11.43±2.16 12.68±2.13 14.98±2.97 3.60±2.32 1.60±2.50 0.46±1.42 4.02±1.18 3.32±2.21 2.91±2.32 3.99±1.62 <0.01 <0.01 >0.05 <0.01 <0.01 <0.01 <0.01
Tactile memory is understood memory and is recited digital MQ 10.88±3.14 12.54±2.64 9.71±2.69 96.78±7.11 13.90±2.43 15.66±1.96 13.16±1.66 111.46±8.35 3.02±2.47 3.14±1.98 3.45±1.50 14.68±4.66 <0.01 <0.01 <0.01 <0.01
Four, discuss
Evaluation for cardiac function, the subjectivity performance before and after contrast is tried and the change of electrocardiogram objective evidence are the means of the embodiment of the invention, and the evaluation brain function, the memory force measurement is a reliable aspect, the Webster memory capacitance is classical instrument in the world, Gong Yao waits (1980) to revise this test earlier, and it shows reliability, validity is satisfied, has obtained using widely in clinical position.General international standard, good reliability are adopted in this test.
The present invention is a compound preparation that comprises Radix Salviae Miltiorrhizae extract, Huperziaserrata extract and Folium Ginkgo extract pure natural components, because each composition has reliably and the mechanism through confirming, wherein, the anti-oxidation function of Folium Ginkgo extract and protection blood vessel endothelium are avoided damage; Radix Salviae Miltiorrhizae extract can improve heart and brain blood is provided with and microcirculation, improves the blood oxygen supply of heart and brain; And the extract of Herba Lycopodii serrati, huperzine A can improve the synaptic contact between the neuron.This result of the test shows that in the human trial level, test group can be improved cardiac function, improving memory.And safe, there is not untoward reaction.
Therefore, the present invention confirms rational compatibility in clinical level, at a plurality of links, breaks through the effect limitation of each single composition, can play a role comprehensively and effectively, plays and improves and the protection cardio cerebral function, thereby play function in delaying senility.

Claims (4)

1, a kind of pure natural oral formulations of protecting and improving cardio cerebral function, it is characterized in that: its effective ingredient is made up of Folium Ginkgo extract, Radix Salviae Miltiorrhizae extract and Huperziaserrata extract, wherein:
The per unit dosage form contains Folium Ginkgo extract 25mg, and effective ingredient is ginkgetin, bilobalide, and content is ginkgetin 6mg, bilobalide 1.5mg;
The per unit dosage form contains Huperziaserrata extract 0.5mg, and effective ingredient is a huperzine A, and content is 50 μ g;
The per unit dosage form contains Radix Salviae Miltiorrhizae extract 2mg, and effective ingredient is Tanshinone I, tanshinone, cryptotanshinone and danshensu, is the content evaluation index with the tanshinone, and content is 0.2mg.
2, a kind of pure natural oral formulations of protecting and improving cardio cerebral function according to claim 1, it is characterized in that: described oral formulations is capsule, oral liquid, electuary or tablet.
3, a kind of preparation method of protecting and improving the pure natural oral formulations of cardio cerebral function is characterized in that this method comprises the steps:
1) gets the raw materials ready: according to the described oral formulations of claim 1 each composition of ormal weight is added the adjuvant that an amount of galenic pharmacy is accepted, fully mixing;
2) granulate; 3) oven dry; 4) sterilization; 5) packing gets final product.
4, a kind of preparation method of protecting and improving the pure natural oral formulations of cardio cerebral function according to claim 3 is characterized in that: the adjuvant that described galenic pharmacy is accepted is selected from starch, dextrin, cane sugar powder, essence, magnesium carbonate and magnesium stearate.
CN 200410001133 2004-01-29 2004-01-29 Natural composite preparation for protecting and improving cerebral and heart function and its preparation method Expired - Fee Related CN1236766C (en)

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CN105943603A (en) * 2016-06-27 2016-09-21 湖南科技学院 Traditional Chinese medicine for preventing and treating senile dementias
CN106420771A (en) * 2016-12-09 2017-02-22 中国药科大学 Joint application of dihydrotanshinone I and protocatechualdehyde to preparation of medicines for treating acute myocardial infarction

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