CN105920476B - Traditional Chinese medicine composition for preventing and treating Alzheimer disease and preparation method thereof - Google Patents
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Abstract
The invention discloses a traditional Chinese medicine composition for preventing and treating Alzheimer disease and a preparation method thereof. The composition contains 1-12 parts by weight of phosphatidylserine and also contains the following traditional Chinese medicine components in parts by weight: 10-180 parts of ginseng, 10-200 parts of gastrodia elata, 30-240 parts of ginkgo leaves, 10-200 parts of polygala tenuifolia and 10-120 parts of galangal; or 10-180 parts of ginseng and the following Chinese medicinal material extracts: 10-200 parts of gastrodia elata extract, 30-240 parts of ginkgo biloba extract, 10-200 parts of polygala tenuifolia extract and 10-120 parts of galangal extract; or 10-180 parts of ginseng, 10-200 parts of gastrodia elata, 30-240 parts of ginkgo leaves, 10-200 parts of polygala tenuifolia and 10-120 parts of galangal. The traditional Chinese medicine composition for preventing and treating the Alzheimer disease has the effects of tonifying liver and nourishing marrow, dredging collaterals and reducing phlegm, promoting intelligence and strengthening brain and the like, can be used for clinically and obviously improving memory and mild cognitive dysfunction, and has no toxic or side effect after long-term administration.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine composition for preventing and treating Alzheimer disease, a preparation method thereof, and a medicine or health-care product containing the composition.
Background
China has entered into a population aging society, and statistical data shows that by the end of 2014, the population of the elderly aged over 60 years old in China reaches 2.12 hundred million, which accounts for 15.5% of the total population, and China becomes a global old nation. It has been reported that 10% of the elderly over 65 years have senile dementia and the prevalence over 80 years is as high as 20% worldwide. Senile dementia (Alzheimer's disease, AD) has become the fourth leading killer after heart disease, cancer and stroke in human beings. Epidemiological investigation shows that at least over 600 million senile dementia patients in China have medicine cost of over 300 million yuan per year.
Modern medical research shows that the pathogenesis of Alzheimer's disease is very complex, involving multiple gene defects, environmental influences, neurotoxins, apoptosis, oxidative stress, β -AP (β amyloid) aggregation, inflammatory reactions, Ca2+Multiple system degeneration such as overload and cholinergic, and the like. Aiming at the pathogenesis of the Alzheimer disease, the current therapeutic drugs on the market mainly comprise cholinesterase inhibitors, glutamate receptor antagonists, calcium ion antagonists, free radical scavengers, antioxidants, estrogens and the like. The medicines mainly take chemical medicines, and have large toxic and side effects. In 2010, European guidelines on AD treatment indicate that cholinesterase inhibitors are preferred for AD drug therapy. However, because AD needs to be taken for a long time, the cholinesterase inhibitor has drug resistance after being taken for a long time. In view of the limitations of the current western medicines on the treatment effect of AD, adverse reactions and the complexity of the causes of AD, the characteristics and advantages of the traditional Chinese medicines are fully exerted, the overall comprehensive regulation and treatment are realized, and multiple links and multiple targets play roles, so that the development of a novel traditional Chinese medicine/health-care product for safely and effectively preventing and treating the Alzheimer disease is imperative and urgent.
The prior patent explains the etiology and pathogenesis of the AD, but the systematic understanding is not formed. For example, in chinese patent CN 105056151A, a pill for treating alzheimer disease is disclosed, which is prepared by combining the following Chinese medicinal herbs in parts by mass: 15 parts of buffalo horn, 15 parts of prepared rehmannia root, 20 parts of achyranthes root, 15 parts of grassleaf sweelflag rhizome, 20 parts of turtle shell, 30 parts of calcined oyster shell, 15 parts of cape jasmine, 15 parts of turmeric root-tuber, 15 parts of dried orange peel, 15 parts of wrinkled gianthyssop herb, 10 parts of bamboo leaf, 15 parts of isatis root and 15 parts of honeysuckle flower. Chinese patent CN 104997943A discloses a traditional Chinese medicine for treating Alzheimer disease, which is prepared from the following raw medicinal materials in parts by weight: 10 parts of Chinese blumea herb, 10 parts of Chenhu luya, 10 parts of cimicifuga foetida, 18 parts of radix scutellariae, 18 parts of madder, 20 parts of tuber fleeceflower stem and 10 parts of Galanthus aromatica. Chinese patent CN 104069424A discloses a traditional Chinese medicine for treating Alzheimer disease, which is prepared from the following raw material medicines in parts by weight: 5-20 parts of morinda officinalis, 5-20 parts of rhizoma acori graminei, 5-30 parts of radix curcumae, 5-30 parts of astragalus membranaceus and 1-20 parts of polygala tenuifolia.
In view of the improvement of advanced research and understanding of AD in modern medicine, the invention is provided according to years of clinical accumulation and scientific research and verification.
Disclosure of Invention
The invention aims to overcome the defects in the prior art, and provides a traditional Chinese medicine composition for preventing and treating alzheimer disease and a preparation method thereof, so as to solve the technical problem that the existing treatment effect for preventing and treating alzheimer disease is not ideal.
The invention also aims to provide a medicament or health-care product for preventing and treating the Alzheimer disease, so as to provide a product with definite curative effect for preventing and treating the Alzheimer disease.
In order to achieve the above object, in one aspect, the embodiments of the present invention provide a traditional Chinese medicine composition for preventing and treating alzheimer disease. The traditional Chinese medicine composition for preventing and treating the Alzheimer disease contains 1-12 parts by weight of phosphatidylserine and also contains the following traditional Chinese medicine components in parts by weight:
10-180 parts of ginseng, 10-200 parts of gastrodia elata, 30-240 parts of ginkgo leaves, 10-200 parts of polygala tenuifolia and 10-120 parts of galangal; or
10-180 parts of ginseng and the following traditional Chinese medicine extracts: 10-200 parts of gastrodia elata extract, 30-240 parts of ginkgo biloba extract, 10-200 parts of polygala tenuifolia extract and 10-120 parts of galangal extract; or
10-180 parts of ginseng, 10-200 parts of gastrodia elata, 30-240 parts of ginkgo leaves, 10-200 parts of polygala tenuifolia and 10-120 parts of galangal.
On the other hand, the embodiment of the invention provides a preparation method of a traditional Chinese medicine composition for preventing and treating Alzheimer disease. The method comprises the following steps:
weighing the traditional Chinese medicinal materials of all components according to the phosphatidylserine and the traditional Chinese medicinal components contained in the traditional Chinese medicinal composition for preventing and treating the Alzheimer disease;
crushing the weighed traditional Chinese medicinal materials, and mixing the crushed traditional Chinese medicinal materials with the phosphatidylserine component; or
Soaking the weighed rhizoma gastrodiae, ginkgo leaf, polygala tenuifolia and galangal in a pharmaceutically acceptable solvent, extracting, and collecting an extracting solution; concentrating and drying the extracting solution, and mixing with phosphatidylserine and the crushed ginseng; or
Soaking the weighed traditional Chinese medicinal materials in a pharmaceutically acceptable solvent, extracting, and collecting an extracting solution; and (3) concentrating and drying the extracting solution, and mixing the extracting solution with phosphatidylserine.
In another aspect of the embodiment of the invention, a medicament or health product for preventing and treating alzheimer's disease is provided, which comprises pharmaceutically acceptable auxiliary materials, and also comprises an effective dose of the traditional Chinese medicine composition for preventing and treating alzheimer's disease or the traditional Chinese medicine composition for preventing and treating alzheimer's disease prepared by the preparation method of the composition.
Compared with the prior art, the traditional Chinese medicine composition for preventing and treating the Alzheimer disease takes the gastrodia elata as a monarch drug, the ginseng and the ginkgo leaf as ministerial drugs, the polygala tenuifolia and the galangal as assistant and guide drugs (all the drugs are medicinal and edible traditional Chinese medicinal materials, and are safe and non-toxic, and health-care food and food are commonly used), and the phosphatidyl serine is matched to ensure that all the components have good prevention and treatment effects on the Alzheimer disease according to the monarch, ministerial, assistant and guide effects, clinical tests prove that the composition can improve the space learning ability and space exploration ability of Kunming mice with the Alzheimer disease, increase the RNA and Nissl body contents of cerebral cortex and hippocampus pyramidal cells, has a certain dose-effect relationship in action, improves the metabolism of the brain nucleic acid and the anabolism of protein, promotes and regulates the metabolism of the brain cortex and the RNA metabolism of hippocampus, improves and regulates the metabolism of the whole neurons and the neuron, the traditional Chinese medicine composition has the effects of tonifying liver and nourishing marrow, dredging collaterals and reducing phlegm, benefiting intelligence and strengthening brain and the like, and can be used for clinically and obviously improving memory and mild cognitive dysfunction.
The preparation method of the traditional Chinese medicine composition for preventing and treating the Alzheimer disease treats all components according to fixed steps, so that the quality of the composition is ensured, the obtained traditional Chinese medicine composition for preventing and treating the Alzheimer disease has the effects of tonifying liver and nourishing marrow, dredging collaterals and reducing phlegm, benefiting intelligence and nourishing brain and the like, the memory and mild cognitive dysfunction can be remarkably improved clinically, and the traditional Chinese medicine composition is stable in efficacy, safe and non-toxic, controllable in quality, low in cost and good in industrial feasibility.
The medicine or health food for preventing and treating the Alzheimer disease contains the traditional Chinese medicine composition with effective dose, so that the medicine or health food has obvious effects of tonifying liver and nourishing marrow, dredging collaterals and reducing phlegm, benefiting intelligence and nourishing brain, can be used for clinically and obviously improving memory and mild cognitive dysfunction, has the medicine effect of preventing and treating the Alzheimer disease, and is safe without toxic and side effects.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
The weight of each component mentioned in the description of the embodiment of the present invention may not only refer to the specific content of each component, but also represent the proportional relationship of the weight of each component, and therefore, the content of each component of the composition according to the description of the embodiment of the present invention is scaled up or down within the scope disclosed in the description of the embodiment of the present invention. Specifically, the parts by weight described in the description of the embodiments of the present invention may be in the units of μ g, mg, g, kg, etc. known in the medical field, and may be regarded as weight percentages.
From the perspective of traditional Chinese medicines, the basic pathogenesis of the Alzheimer disease is essence deficiency and marrow reduction, qi and blood deficiency, phlegm and fatigue, obstruction of brain collaterals, and primordial spirit damage and psychogenic disuse. On one hand, the reason is that the mental activities are lost due to the deficiency of viscera, the deficiency of liver and kidney and the malnutrition of brain and marrow; on the other hand, dysfunction of the aged zang-fu organs, stagnation of turbid phlegm and blood stasis, and malnutrition of the clear orifices. The deficiency syndrome is related to the five zang organs, mainly because of deficiency of kidney essence and insufficiency of spleen, but mainly because of deficiency of kidney essence; excess syndrome is caused by unsmooth circulation of qi, blood and body fluids in the body, and can lead to fatigue, phlegm, obstruction of brain collaterals, and obstruction of orifices. Meanwhile, they can affect each other to cause excess due to deficiency and cause healthy qi to be damaged by excess, and then they are combined into diseases with intermingled deficiency and excess. For the disease, the kidney tonifying and phlegm reducing are mainly used clinically, on the basis of deep research on pathogenesis, the invention provides the prescription for treating liver diseases, tonifying liver and nourishing marrow, promoting blood circulation to remove blood stasis, eliminating phlegm for resuscitation, benefiting intelligence and strengthening brain, and the like, and the effect is obvious through years of clinical observation.
Based on the cognition on the basic pathogenesis of the Alzheimer disease, on one hand, the embodiment of the invention provides a traditional Chinese medicine composition for preventing and treating the Alzheimer disease. In one embodiment, the traditional Chinese medicine composition for preventing and treating alzheimer disease in the embodiment of the invention contains 1-12 parts by weight of phosphatidylserine, and also contains the following traditional Chinese medicine components in parts by weight: 10-180 parts of ginseng, 10-200 parts of gastrodia elata, 30-240 parts of ginkgo leaves, 10-200 parts of polygala tenuifolia and 10-120 parts of galangal.
In another embodiment, the traditional Chinese medicine composition for preventing and treating alzheimer disease provided by the embodiment of the invention contains 1-12 parts by weight of phosphatidylserine, and also contains the following traditional Chinese medicine components in parts by weight: 10-180 parts of ginseng and the following traditional Chinese medicine extracts: 10-200 parts of gastrodia elata extract, 30-240 parts of ginkgo biloba extract, 10-200 parts of polygala tenuifolia extract and 10-120 parts of galangal extract.
In another embodiment, the traditional Chinese medicine composition for preventing and treating alzheimer disease in the embodiment of the invention contains 1-12 parts by weight of phosphatidylserine, and also contains the following traditional Chinese medicine components in parts by weight: 10-180 parts of ginseng, 10-200 parts of gastrodia elata, 30-240 parts of ginkgo leaves, 10-200 parts of polygala tenuifolia and 10-120 parts of galangal.
Therefore, the traditional Chinese medicine composition for preventing and treating the Alzheimer disease has a good prevention and treatment effect on the Alzheimer disease by taking the gastrodia elata as a monarch drug, the ginseng and the ginkgo leaves as ministerial drugs, the polygala tenuifolia and the galangal as assistant and guide drugs and matching with the phosphatidylserine.
Wherein, the monarch drug Gastrodia elata has sweet and mild nature and enters liver meridian. Has effects in calming endogenous wind, arresting convulsion, resisting rheumatism, resisting epilepsia, relieving convulsion, tranquilizing mind, and relieving spasm, and can be used for treating headache, giddiness, limbs anesthesia, infantile convulsion, epilepsia tetany, etc. The main active ingredients of the medicine are gastrodin, vanillin, p-hydroxybenzaldehyde, p-hydroxybenzyl alcohol and the like. Research shows that the gastrodia elata has the effects of expanding blood vessels, enhancing the elasticity of the blood vessels and improving the blood supply of basilar arteries; can be used for preventing and treating senile dementia by repairing brain cell injury, protecting cerebral vessels, improving synaptic plasticity injury of hippocampal region, and inhibiting apoptosis of hippocampal nerve cells; increasing cerebral tissue blood perfusion, relieving cerebral ischemia reperfusion injury, regulating neurotransmitter level, regulating expression level of part of aging related genes and weakening apoptosis pathway to play a role in protecting brain; gastrodine and rhizoma Gastrodiae polysaccharide can promote cellular immunity and humoral immunity, fully exert antioxidant effect, effectively remove lipid peroxide of blood serum, brain and other tissues, and improve activity of multiple antioxidant enzymes. With the continuous and intensive research on the gastrodin, in recent years, gastrodin is found to enter the brain through the blood brain barrier, rapidly decompose into gastrodin in the brain, blood and liver, remain in tissues in the form of gastrodin, have the effects of scavenging free radicals, resisting oxidation, inhibiting central nerve cell apoptosis and the like, and have a certain curative effect on AD.
Ginseng, sweet in taste, slightly bitter in flavor, neutral in nature, enters lung, spleen and heart meridians. The Shen is listed as the superior in Shen nong Ben Cao Jing, which says that the Shen is mainly used for tonifying the five internal organs, calming the spirit, calming the soul, stopping palpitation, improving eyesight, opening heart and benefiting intelligence, and has the effects of reducing weight and prolonging life after being taken for a long time. Modern researches have further developed the efficacy of ginseng, and a large number of experiments and clinical researches show that the ginseng serving as a tonic representative has the efficacy of preventing and treating senile dementia. The doctors generally believe that the ginseng and the compound preparation thereof can prevent and treat senile dementia, and the memory, the orientation and the comprehension of senile dementia patients are obviously improved mainly by methods of tonifying qi and nourishing blood, tonifying kidney and replenishing essence. Research shows that the ginseng is mainly used for preventing and treating senile dementia through the following mechanisms: increasing acetylcholine content in brain, promoting synthesis of brain protein and nucleic acid, improving hippocampal neuron function, antagonizing calcium overload, and promoting brain nerve cell development.
The ginkgo biloba leaves, which have sweet, bitter, astringent and mild natures, enter heart and lung channels, have the functions of promoting blood circulation, removing blood stasis, dredging collaterals, relieving pain, astringing lung, relieving asthma, relieving diarrhea with astringents, eliminating turbid pathogen and reducing blood fat, and the main component of the ginkgo biloba flavone has the functions of expanding coronary arteries, improving coronary blood flow, relieving angina, reducing blood fat, resisting lipid oxidation, promoting cerebral blood flow, improving cerebral metabolism and the like.
Phosphatidylserine is known as a new "smart nutrient" following choline and "brain gold" DHA, and is an active substance of cell membranes, especially present in brain cells. Has the functions of improving nerve cell function, regulating the conduction of nerve pulse and enhancing the memory function of brain, and can quickly enter the brain through a blood brain barrier after being absorbed due to good lipophilicity, thereby playing the roles of relieving blood vessel smooth muscle cells and increasing the blood supply of the brain. With the age of people, the brain phosphatidylserine and other important chemical substances are gradually reduced, so that the memory and cognition are weakened. Proper amount of phosphatidylserine can increase the number of brain spurs, the fluidity of brain cell membranes and promote the metabolism of glucose in brain cells, thereby enabling the brain cells to be more active, promoting the concentration of attention and improving the alertness and the memory.
Rhizoma gastrodiae, ginseng, ginkgo leaf, polygala root and galangal are all raw materials approved by the national ministry of health to be used as health-care food. Phosphatidylserine is a new resource food approved by the national ministry of health in 2010. The composition has effects of regulating and treating Alzheimer disease in aspects of Chinese medicine regulation and western medicine nutrition, and has advantages of definite action, good effect, safety and no adverse side effect.
As a preferred embodiment, the traditional Chinese medicine composition for preventing and treating Alzheimer's disease comprises 30-90 parts of ginseng, 30-100 parts of rhizoma gastrodiae, 60-120 parts of ginkgo biloba, 30-100 parts of polygala tenuifolia, 30-60 parts of galangal and 2-8 parts of phosphatidylserine.
In a specific embodiment, the traditional Chinese medicine composition for preventing and treating alzheimer disease comprises 20 parts of ginseng, 60 parts of gastrodia elata, 60 parts of ginkgo leaves, 40 parts of polygala tenuifolia, 30 parts of galangal and 6 parts of phosphatidylserine.
The prescription enables the components to play a role of assistant and guide by optimizing the compatibility content of the components of the medicinal materials, and further the compatibility balance of the prescription enables the traditional Chinese medicine composition for preventing and treating the Alzheimer disease disclosed by the embodiment of the invention to have the effects of tonifying liver and nourishing marrow, dredging collaterals and reducing phlegm, benefiting intelligence and nourishing brain and the like, and can be used for clinically and obviously improving memory and mild cognitive dysfunction, so that the efficacy of the traditional Chinese medicine composition for preventing and treating the Alzheimer disease disclosed by the embodiment of the invention is improved. In addition, all the medicinal materials are medicinal and edible traditional Chinese medicinal materials, are safe and nontoxic, and are commonly used for health-care food and food, so the Chinese medicinal composition has no toxic or side effect.
In addition, the extracts in the above embodiments can be obtained by extracting the corresponding traditional Chinese medicinal materials in the prescription with pharmaceutically acceptable solvents. In a preferred embodiment, the extraction is performed by boiling the solvent or by boiling the solvent under hot conditions, although other acceptable extraction methods may be used. In specific embodiment, the extraction treatment time under solvent boiling or hot boiling condition is 0.5-2.0 h. In another specific embodiment, the weight ratio of the total weight of the Chinese medicinal materials to the solvent is 1 (6-15); further, the soaking time is 0-1.0 h. The control of the active ingredients and content of the extracted medicine is realized by controlling the process conditions, so that the traditional Chinese medicine composition for preventing and treating the Alzheimer disease provided by the embodiment of the invention has good clinical efficacy.
On the other hand, on the basis of the above embodiments of the present invention, the embodiments of the present invention provide the following methods for preparing the above traditional Chinese medicine composition for preventing and treating alzheimer's disease.
In one embodiment, the preparation method of the traditional Chinese medicine composition for preventing and treating alzheimer disease comprises the following steps:
step S01: weighing the Chinese medicinal materials according to the ginseng, the phosphatidylserine and the Chinese medicinal components contained in the Chinese medicinal composition for preventing and treating the Alzheimer disease;
step S02: and (5) crushing the Chinese medicinal materials weighed in the step (S01) and mixing the crushed Chinese medicinal materials with the phosphatidylserine component.
The components and the contents of the components of the traditional Chinese medicine composition for preventing and treating alzheimer' S disease in the step S01 are as described above, and are not repeated herein for the sake of brevity.
The pulverizing process in step S02 may be performed according to a conventional method in the field of traditional Chinese medicine, for example, the pulverizing process is performed according to the requirement of powder, in a specific embodiment, the pulverized mixture is sieved by a sieve of 60-100 meshes.
In another embodiment, the preparation method of the traditional Chinese medicine composition for preventing and treating alzheimer disease provided by the embodiment of the invention comprises the following steps:
step S03: weighing the Chinese medicinal materials according to the ginseng, the phosphatidylserine and the Chinese medicinal components contained in the Chinese medicinal composition for preventing and treating the Alzheimer disease;
step S04: soaking the weighed rhizoma gastrodiae, ginkgo leaf, polygala tenuifolia and galangal in a pharmaceutically acceptable solvent, extracting, and collecting an extracting solution; concentrating the extractive solution, drying, mixing with phosphatidylserine and pulverized Ginseng radix.
The step S03 is the same as the step S01, and is not repeated herein for brevity.
In the step S04, the rhizoma gastrodiae, the folium ginkgo, the polygala tenuifolia and the galangal are soaked in a pharmaceutically acceptable solvent to soak the traditional Chinese medicine raw materials so as to evaporate the effective functional components in the traditional Chinese medicine raw materials, and the distillation time is shortened, so that the efficiency is improved. Directly carrying out distillation treatment after soaking treatment.
In one embodiment, in the step of soaking the weighed rhizoma gastrodiae, folium ginkgo, polygala tenuifolia and galangal in the pharmaceutically acceptable solvent in step S04, the weight ratio of the total weight of the rhizoma gastrodiae, the folium ginkgo, the polygala tenuifolia and the galangal to the solvent is 1 (6-15); or in a further embodiment, the soaking treatment time is 0-1.0 h. The extraction amount and the extraction rate are improved by controlling the dosage of the prescription components and the solvent and the soaking time. In a specific embodiment, the soaking treatment is a soaking treatment in a closed environment.
In one embodiment, the extraction process of step S04 is performed by heat treating the solvent mixture, such as heating to boil the solvent. In further embodiment, the time of solvent boiling extraction treatment is controlled to be 0.5-2.0 h. Wherein the extraction process may be performed at least once.
Therefore, in a specific embodiment, the step S04 of soaking the weighed rhizoma gastrodiae, folium ginkgo, polygala tenuifolia and galangal in a pharmaceutically acceptable solvent and then extracting comprises the steps of adding the rhizoma gastrodiae, folium ginkgo, polygala tenuifolia and galangal in the solvent, soaking in a closed environment, heating, boiling, extracting for 0.5-2.0h, and filtering; adding the filter residue into the solvent, heating, boiling and extracting for a second time for 0.5-2.0 h. Wherein the weight ratio of the total weight of the rhizoma gastrodiae, the ginkgo leaves, the polygala root and the galangal to the solvent is (6-15); the soaking time is 0-1.0h but not only; the filter residue is added into the solvent according to the weight ratio of the total weight of the traditional Chinese medicinal materials of the gastrodia elata, the ginkgo leaves, the polygala tenuifolia and the galangal to the solvent of 1 (5-10).
In the above embodiments, the solvent in step S04 is water or ethanol water. The solvent can be used for effectively extracting effective components with medicinal effects, and the extracted extract is safe and low in cost.
In step S04, the concentration process is performed to remove part or all of the extraction solvent. In one embodiment, the temperature of the concentration process is controlled to be 50-99 ℃. The concentration treatment at the temperature can not only avoid the drug effect reduction caused by the destruction or volatilization of the active ingredients of the drug, but also effectively remove part or all of the solvent. The concentration treatment is preferably carried out by vacuum concentration, so that on the one hand, the high temperature can be avoided, and partial functional components are decomposed and lose efficacy, on the other hand, the volatilization of water can be effectively accelerated, and the time of the concentration treatment can be shortened.
In step S04, the drying process may be a drying method that is conventional in the art without destroying or volatilizing the extracted active ingredients. In one aspect, the drying process is a spray drying process; wherein the spray drying treatment has a spray temperature of: 150 ℃ and 210 ℃, and the outlet temperature is 60-99 ℃.
In step S04, the pulverized ginseng is obtained by sieving the pulverized ginseng with a 60-200 mesh sieve.
The mixing process in step S04 is to mix the components uniformly, and therefore, the mixing process may be a conventional mixing process in the art that can achieve the purpose.
In another embodiment, the preparation method of the traditional Chinese medicine composition for preventing and treating alzheimer disease provided by the embodiment of the invention comprises the following steps:
step S05: weighing the Chinese medicinal materials according to the ginseng, the phosphatidylserine and the Chinese medicinal components contained in the Chinese medicinal composition for preventing and treating the Alzheimer disease;
step S06: soaking the weighed traditional Chinese medicinal materials in a pharmaceutically acceptable solvent, extracting, and collecting an extracting solution; and (3) concentrating and drying the extracting solution, and mixing the extracting solution with phosphatidylserine.
The step S05 is the same as the step S01, and is not repeated herein for brevity.
The soaking process, the extracting solution concentrating process and the drying process in the step S06 are the same as those described in the step S06, and are not repeated herein for the sake of brevity.
Therefore, according to the preparation method of the traditional Chinese medicine composition for preventing and treating the alzheimer disease, disclosed by the embodiment of the invention, all the components are treated according to fixed steps, so that the quality of the composition is ensured, the content of the extracted effective components is stable, and the obtained traditional Chinese medicine composition for preventing and treating the alzheimer disease is stable in efficacy, safe, non-toxic and controllable in quality. Low cost and good industrial feasibility.
On the other hand, on the basis of the traditional Chinese medicine composition for preventing and treating the alzheimer disease and the preparation method thereof, the embodiment of the invention also provides a medicine or health-care food for preventing and treating the alzheimer disease. In an embodiment, the medicine or health food for preventing and treating alzheimer's disease in the embodiment of the present invention includes pharmaceutically acceptable excipients, and further includes an effective dose of the above-mentioned traditional Chinese medicine composition for preventing and treating alzheimer's disease in the embodiment of the present invention or the above-mentioned traditional Chinese medicine composition for preventing and treating alzheimer's disease prepared by the above-mentioned preparation method of the traditional Chinese medicine composition for preventing and treating alzheimer's disease in the embodiment of the present invention.
Wherein, the effective dose of the traditional Chinese medicine composition for preventing and treating the Alzheimer disease refers to a therapeutically effective dose, and refers to an amount of the compound which is enough to show benefit or clinical significance to an individual. One skilled in the art will appreciate that the actual amount or dose administered and the time course of administration will depend on the nature and severity of the disease being treated, the age and general condition of the subject being treated, and the mode of administration, among other factors.
In one embodiment, the pharmaceutically acceptable adjuvant contained in the medicament or health food for preventing and treating alzheimer disease in the embodiments of the present invention refers to any adjuvant known to those skilled in the art to be suitable for a specific administration mode. For example, in a specific embodiment, the pharmaceutically acceptable adjuvant may include one or more pharmaceutically acceptable carriers, solvents, excipients, buffers, stabilizers, adjuvants, prodrugs and other therapeutic agents that can be compatible with the traditional Chinese medicine composition for preventing and treating alzheimer's disease according to embodiments of the present invention and can benefit from the prevention and treatment of alzheimer's disease or enhance the activity of the traditional Chinese medicine composition for preventing and treating alzheimer's disease.
It should be understood that the above-mentioned adjuvants should be nontoxic, do not interfere with or impair the efficacy of the above-mentioned traditional Chinese medicine composition for preventing and treating Alzheimer's disease according to the embodiment of the present invention. In addition, the auxiliary materials are selected according to the existing preparation forms of the medicines or health-care foods for preventing and treating the Alzheimer disease in the embodiments and can be flexibly selected.
In addition, the above-mentioned drugs or health foods for preventing and treating alzheimer's disease may be administered alone or in combination with other compositions if necessary.
In an embodiment, according to the administration mode of the drug or health food for preventing and treating alzheimer's disease in the embodiments of the present invention, pharmaceutically acceptable excipients and an effective dose of the traditional Chinese medicine composition for preventing and treating alzheimer's disease can be flexibly selected to prepare different dosage forms, such as any one of a mixture, an oral liquid, a capsule, a tablet, a pill, a powder or a granule.
Therefore, the medicine or health product for preventing and treating alzheimer disease in the embodiment of the invention contains the effective dose of the traditional Chinese medicine composition for preventing and treating alzheimer disease, so that the medicine or health product for preventing and treating alzheimer disease in the embodiment of the invention has obvious effect on preventing and treating alzheimer disease, has no toxic or side effect after long-term administration, and has good clinical compliance.
The invention is further explained by the specific embodiments of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease and the preparation method thereof.
Example 1
The embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer disease and a preparation method thereof. The prescription of the traditional Chinese medicine composition for preventing and treating the Alzheimer disease comprises 50 parts of gastrodia elata, 170 parts of ginseng, 120 parts of ginkgo leaves, 60 parts of polygala tenuifolia, 30 parts of galangal and 6 parts of phosphatidylserine.
The preparation method of the traditional Chinese medicine composition for preventing and treating alzheimer disease comprises the following steps:
s11: taking gastrodia elata, ginseng, ginkgo leaves, polygala tenuifolia, galangal and phosphatidylserine according to a metering ratio;
s12: pulverizing Ginseng radix separately and sieving with 60 mesh sieve to obtain Ginseng radix powder; mixing the rest Chinese medicinal materials, extracting with water twice, adding 12 times of water for the first time, boiling for 1.5 hr, adding 8 times of water for the second time, boiling for 1 hr, and mixing the two extractive solutions;
s13: filtering the extractive solution, and concentrating under reduced pressure to relative density of about 1.10; spray drying, and adding phosphatidyl serine and Ginseng radix powder to obtain Chinese medicinal composition for preventing and treating Alzheimer disease.
Example 2
The embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer disease and a preparation method thereof. The prescription of the traditional Chinese medicine composition for preventing and treating the Alzheimer disease comprises 150 parts of rhizoma gastrodiae, 60 parts of ginseng, 40 parts of ginkgo leaf, 20 parts of polygala tenuifolia, 60 parts of galangal and 10 parts of phosphatidylserine.
The preparation method of the traditional Chinese medicine composition for preventing and treating alzheimer disease comprises the following steps:
s21: taking gastrodia elata, ginseng, ginkgo leaves, polygala tenuifolia, galangal and phosphatidylserine according to a metering ratio;
s22: mixing the Chinese medicinal materials, extracting with 70% ethanol under reflux for 1.5 hr by adding 12 times of 70% ethanol, extracting for 1 hr by adding 8 times of 70% ethanol, and mixing the extractive solutions;
s23: concentrating the extractive solution under reduced pressure, drying under reduced pressure, and pulverizing the dry extract; phosphatidylserine is added.
Example 3
The embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer disease and a preparation method thereof. The prescription of the traditional Chinese medicine composition for preventing and treating the Alzheimer disease comprises 10 parts of gastrodia elata, 180 parts of ginseng, 240 parts of ginkgo leaves, 100 parts of polygala tenuifolia, 20 parts of galangal and 1 part of phosphatidylserine.
The preparation method of the traditional Chinese medicine composition for preventing and treating alzheimer disease comprises the following steps:
s31: taking gastrodia elata, ginseng, ginkgo leaves, polygala tenuifolia, galangal and phosphatidylserine according to a metering ratio;
s31: pulverizing Ginseng radix separately and sieving with 200 mesh sieve to obtain Ginseng radix powder; mixing the rest Chinese medicinal materials, extracting with water twice, adding 15 times of water for the first time, boiling for 2.0 hr, adding 10 times of water for the second time, boiling for 1.5 hr, and mixing the two extractive solutions;
s33: concentrating the extractive solution, drying under reduced pressure, pulverizing dry extract, and mixing with Ginseng radix fine powder and phosphatidylserine.
Example 4
The embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer disease and a preparation method thereof. The prescription of the traditional Chinese medicine composition for preventing and treating the Alzheimer disease comprises 60 parts of gastrodia elata, 20 parts of ginseng, 60 parts of ginkgo leaves, 40 parts of polygala tenuifolia, 30 parts of galangal and 6 parts of phosphatidylserine.
The preparation method of the traditional Chinese medicine composition for preventing and treating alzheimer disease comprises the following steps:
s41: taking gastrodia elata, ginseng, ginkgo leaves, polygala tenuifolia, galangal and phosphatidylserine according to a metering ratio;
s42: pulverizing Ginseng radix separately and sieving with 80 mesh sieve to obtain Ginseng radix powder; mixing the rest Chinese medicinal materials, extracting with water twice, adding 10 times of water for the first time, boiling for 1.5 hr, adding 8 times of water for the second time, boiling for 1.0 hr, and mixing the two extractive solutions;
s43: concentrating the extract, and spray drying; and adding phosphatidyl serine and ginseng powder into the spray-dried powder for mixing.
Example 5
The embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer disease and a preparation method thereof. The prescription of the traditional Chinese medicine composition for preventing and treating the Alzheimer disease comprises 140 parts of gastrodia elata, 10 parts of ginseng, 30 parts of ginkgo leaves, 80 parts of polygala tenuifolia, 60 parts of galangal and 7 parts of phosphatidylserine.
The preparation method of the traditional Chinese medicine composition for preventing and treating alzheimer disease comprises the following steps:
s51: taking gastrodia elata, ginseng, ginkgo leaves, polygala tenuifolia, galangal and phosphatidylserine according to a metering ratio;
s51: mixing the Chinese medicinal materials, extracting with water twice, adding 12 times of water for the first time, boiling for 2.0 hr, adding 8 times of water for the second time, boiling for 1.0 hr, and mixing the two extractive solutions;
s53: concentrating the extract, and spray drying; adding phosphatidylserine and mixing.
Example 6
The embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer disease and a preparation method thereof. The prescription of the traditional Chinese medicine composition for preventing and treating the Alzheimer disease comprises 30 parts of gastrodia elata, 10 parts of ginseng, 40 parts of ginkgo biloba, 40 parts of polygala tenuifolia, 40 parts of galangal and 12 parts of phosphatidylserine.
The preparation method of the traditional Chinese medicine composition for preventing and treating alzheimer disease comprises the following steps:
s61: taking gastrodia elata, ginseng, ginkgo leaves, polygala tenuifolia, galangal and phosphatidylserine according to a metering ratio;
s62: pulverizing the Chinese medicinal materials, and sieving with 80 mesh sieve; adding phosphatidylserine, and mixing to obtain powder product.
Example 7
The embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer disease and a preparation method thereof. The prescription of the traditional Chinese medicine composition for preventing and treating the Alzheimer disease comprises 180 parts of gastrodia elata, 70 parts of ginseng, 70 parts of ginkgo leaves, 200 parts of polygala tenuifolia, 60 parts of galangal and 3 parts of phosphatidylserine.
Clinical trial
1. Test unit
Shenzhen, the institute of old medicine.
2. Purpose of experiment
The composition provided by the invention is used for preventing and treating Alzheimer disease and improving memory.
3. Experimental Material
Sample 1 was provided by the institute of geriatric medicine of shenzhen city (the traditional Chinese medicine composition prepared in example 4 and the auxiliary materials were added to prepare tablets), the appearance was brown tablets, the recommended amount for oral administration to human body was 0.8 g/tablet, 3 tablets each time, 3 times a day, calculated as 60kg body weight of each person, and the reduced dose was 0.12 g/kg.bw.
The traditional Chinese medicine composition is provided by Shenzhen aged medical research institute (the formula in example 4 is used, phosphatidyl serine is deducted, and the rest is prepared according to example 4), the appearance is brown tablets, the recommended oral dose for human bodies is 0.75 g/tablet, 3 tablets are taken each time, 3 times are taken each day, the calculated weight of 60kg of each person is taken, and the reduced dose is 0.11 g/kg.bw.
Phosphatidylserine is provided by Shanxi Guanjie Biotechnology GmbH, the recommended dose for oral administration of human body is 600 mg/day, calculated by the weight of 60kg of human body, and the dosage is 10mg/kg.
Huperzine A tablet is provided by Shicheng pharmaceutical Co., Ltd, and is 0.05 mg/tablet, 4 tablets at a time, 2 times a day, calculated as 60kg body weight per person, and has a reduced dose of 0.007 mg/kg.bw.
4. Experimental methods
4.1 dose setting
The dose settings for each sample are shown in table 1. The samples of each dosage group are dissolved, diluted and subjected to constant volume to be in a proper intragastric administration volume.
TABLE 1 dosage in terms of body weight
4.2 test methods
4.2.1 learning and memory behavioural animal test
Animals were acclimatized for 3d before starting experimental group observations. The experiment is divided into two batches of a memory acquisition obstacle model and a memory reproduction obstacle model, 80 animals are used in each batch of experiment, the mice are randomly divided into a normal control group, a model control group, a sample 1 high, medium and low dose group, a traditional Chinese medicine composition group, a phosphatidylserine group and a huperzine A group, 10 mice are used in each group, corresponding preparations are given according to grouping conditions for intragastric administration, 1 time a day and 7 days continuously.
4.2.1.1 preparation of memory impairment model and testing of scopolamine (3mg/kg, ip) preparation of memory impairment model. The experimental animals are continuously administered with corresponding test substances for 30 days according to grouping conditions, 30min after the test substances are administered at the 30 th day, the model control group, the sample 1 high, medium and low dose groups, the traditional Chinese medicine composition group, the phosphatidylserine group and the huperzine A group are subjected to intraperitoneal injection by using scopolamine (3mg/kg), and the jump method training is started after 10 min. 30min after the test object is given at 31d, the test of memory performance is carried out by a jump table method.
4.2.1.2 preparation of memory dysgenesis model and group trial 40% ethanol (0.1mL/10g, ig) was used to prepare the memory dysgenesis model. The experimental animals are continuously given corresponding test substances for 30d according to grouping conditions, and after 30d is given test drugs for 30min, the dark method training is carried out. 30min after the test object is given at 31d, the model control group, the sample 1 high, medium and low dose groups, the traditional Chinese medicine composition group, the phosphatidylserine group and the huperzine A group are gavaged by using 40% ethanol with the amount of 0.1mL/10g of body weight, and the memory performance is tested after 30 min.
4.2.1.3 diving platform test the mouse is placed in a diving platform instrument, after adapting to the environment for 5min, the mouse is lightly placed on a platform, and when the animal jumps down from the diving platform and the four limbs contact the copper grid, the mouse is stimulated by 40V alternating voltage. The normal response in mice was a jump back to the platform to avoid nociceptive stimulation. The animal may jump off the platform again or multiple times and jump back to the platform after receiving an electric shock. And (5) recording the number of errors when the mouse jumps down the platform and contacts the copper grid by both feet, and training for 5 min. And testing the memory performance after 24 h. The mice are placed on the platform, the latency (SL) of the mice staying on the safe platform and the number of times of shocking within 3min (error number) of the mice are recorded, and if the mice stay on the platform for more than 3min, the latency is counted by 180 s.
4.2.1.4 darkness avoidance test 30min after the last administration, the mouse was trained, the mouse was placed in the light room with the face back to the opening, and a timer was started. The animal enters the darkroom through the hole to be shocked, and the animal stops automatically when the animal is timed. And taking out the mouse, and recording the time required for the mouse to encounter the electric shock when the mouse is put into a bright room and enters a dark room, wherein the latency period is the time. The test was repeated 24h later, and the latency of each animal entering the dark room and the number of shocks 5min (those not entering the dark room within 5min, with latency counted in 300 s) were recorded.
4.2.2 quantitative detection of RNA and Nissl bodies in relevant brain regions
4.2.2.1 after the observation of the administration of the section obtained from the material and the examination of learning and memory, 8 mice were randomly selected from each group in the dark avoidance experiment, 1% pentobarbital sodium (40mg/Kg body weight, intraperitoneal injection) was anesthetized and the chest was opened, the left ventricle aorta was cannulated and ligated, 50mL of saline was washed, then the fixed perfusion with the cold paraformaldehyde glutaraldehyde perfusion fixative was performed, the brain was fixed in the perfusion for 2h (4 ℃), then placed in 20% sucrose buffer (0.1M, pH7.4) for 24h (4 ℃), and the serial sections of the crowns of AO cryomicrotome were sliced with a thickness of 30 μ M, and the sections were collected in 0.1MPBS for later use.
4.2.2.2 incubation slide
4.2.2.2.1RNA histochemical staining Elias: the slices descend to the water; adding into dye solution (0.5% methyl green 10mL plus guaranin Y20 mg) at 37 deg.C, and incubating for 1 h; washing with distilled water at 0-2 deg.C for 2 min; washing with tert-butyl alcohol; dehydrating the tertiary butanol for 2 times and 3 min/time; xylene transparent neutral gum coverslip (on photo RNase solution (8mg RNase in 10mL distilled water) digested at 37 deg.C for 1h and then into dye solution).
4.2.2.2.2 degreasing Nissl body-dyed section with xylene for 2 times, each time for 3min, and descending to water; 1% tar violet dye liquor for 10min at 37 ℃; 70% ethanol for 3 times, 1 min/time; 95% ethanol for 3 times, 1 min/time; anhydrous ethanol for 3 times, 1 min/time; the xylene is transparent for 2 times and 5 min/time; and (5) sealing the neutral gum.
4.2.2.2.3 quantitative detection and analysis adopt LM ZEISS Axiotron research type microscope, JVC KY-F30B3-CCD variacam freezing video recorder and Kontron IBAS 2.0 fully automatic image analyzer. Selecting the third layer of temporal cortex, namely the outer pyramidal cell layer, in the cerebral cortex measuring region, measuring pyramidal cells in a CA1 region by the hippocampus, respectively detecting the optical density of RNA and Nissl somatic cell chemical reactants in a unit area, subtracting a background OD value from the OD value of a positive reactant to obtain a corrected OD value (COD), namely randomly extracting 3 slices from each index of the actual optical density of a reaction product, and randomly measuring 3 visual fields in the measuring region by each slice, wherein all the measurements are completed under the same optical condition.
4.3 statistics of test data
Data are expressed as mean ± standard deviation (mean ± SD), statistical analysis is performed by using SPSS17.0 software, and alignment between groups is performed by using a t-test in groups, and when P is less than 0.05, significant differences between groups are indicated.
5. Results of the experiment
5.1 Effect of the composition on learning and memory behaviours in model mice
5.1.1 Effect of the composition on mouse diving platform test latency and error frequency
As can be seen from Table 2, the mouse diving tower latency of each administration group is prolonged to some extent and the number of errors is reduced compared with the model group, wherein the differences between the latency and the number of errors of the sample 1 high/medium dose group, the traditional Chinese medicine composition group and the huperzine A group are statistically significant (P <0.05) compared with the model group. The results show that the composition, the traditional Chinese medicine composition and the huperzine A have remarkable promotion effect on the acquisition of memory.
And (3) analyzing interaction properties, namely analyzing a dose group, a traditional Chinese medicine composition group and a phosphatidylserine group in the sample 1, wherein the traditional Chinese medicine composition and the phosphatidylserine are used in a compatible manner, the effect is superior to that of the traditional Chinese medicine composition and the phosphatidylserine which are used independently, and the traditional Chinese medicine composition and the phosphatidylserine have a synergistic effect (E)Dose group in sample 1>EChinese medicinal composition+EPhosphatidylserine)。
TABLE 2 Effect of compositions on mouse Pop-Up test latency and error frequency: (
n＝10)
(model of disorder of memory acquisition)
Note: p <0.05 compared to normal group; compared with the model group, # P <0.05
5.1.2 Effect of the composition on mouse dark avoidance test latency and error times
As can be seen from Table 3, the dark-avoidance latency of mice in each administration group was prolonged to some extent and the number of errors was reduced as compared with the model group. Wherein, the latency of the high, medium and low dose groups, the traditional Chinese medicine composition group, the phosphatidylserine group and the huperzine A group of the sample 1 is compared with that of the model group, and the difference has statistical significance (P is less than 0.05); the error frequency of the sample high and medium dose groups, the traditional Chinese medicine composition group and the huperzine A group is compared with that of the model group, and the difference has statistical significance (P is less than 0.05). The results show that the composition, the traditional Chinese medicine composition, the phosphatidylserine and the huperzine A have obvious promotion effect on the memory reproduction process.
And (3) analyzing interaction properties, namely analyzing a dose group, a traditional Chinese medicine composition group and a phosphatidylserine group in the sample 1, wherein the traditional Chinese medicine composition and the phosphatidylserine are used in a compatible manner, the effect of prolonging the dark-avoiding latency period is better than that of the traditional Chinese medicine composition and the phosphatidylserine which are used independently, and the two have a synergistic effect (E)Dose group in sample 1>EChinese medicinal composition+EPhosphatidylserine)。
TABLE 3 Effect of compositions on mouse dark avoidance test latency and number of errors: (
n＝10)
(model of memory reproduction disorder)
Note: p <0.05 compared to normal group; compared with the model group, # P <0.05
5.2 qualitative and quantitative analysis of RNA and Nissl body in relevant brain region of model mouse by composition
As can be seen from the results in Table 4, the contents of RNA and Nissl bodies in normal mouse neurons, particularly cortex and hippocampal pyramidal neurons, are very rich, which indicates that the metabolism of related neuron cells is vigorous, the contents of RNA and Nissl bodies in a model group are obviously reduced, which indicates that the cell metabolism is disordered, and each dosage group of the sample 1 can improve the contents of RNA and Nissl bodies in temporal cortex and hippocampal pyramidal cells of the model mouse to different degrees, which indicates that the composition can obviously improve the nucleic acid metabolism and the protein anabolism of senile dementia mice, improve and regulate the metabolism of the whole neurons, and play a role in preventing and treating the Alzheimer disease.
TABLE 4 Effect of composition on RNA and Nissl body content in vertebral body cells in extratemporal cortex and hippocampal CA1 region of model mice (II)n＝8)
Note: p <0.05 compared to normal group; compared with the model group, # P <0.01, # P <0.05
According to the experimental results, researches show that the traditional Chinese medicine composition for preventing and treating the alzheimer disease provided by the embodiment of the invention can improve the space learning ability and the space exploration ability of alzheimer disease Kunming mice, increase the content of RNA and Nissl in cerebral cortex and hippocampal pyramidal cells, has a certain dose-effect relationship in the action, improves the metabolism of brain nucleic acid and the anabolism of protein, promotes and regulates the RNA metabolism of the cerebral cortex and the hippocampus, improves and regulates the metabolism of whole neurons and learns and memorizes the neuron structures of key brain regions, and plays a role in preventing and treating the alzheimer disease.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included within the scope of the present invention.
Claims (7)
1. A traditional Chinese medicine composition for preventing and treating Alzheimer disease is characterized by comprising the following components: 6 parts of phosphatidylserine and the following traditional Chinese medicine components in parts by weight:
20 parts of ginseng, 60 parts of gastrodia elata, 60 parts of ginkgo leaves, 40 parts of polygala tenuifolia and 30 parts of galangal; or
20 parts of ginseng and the following Chinese medicinal material extracts: 60 parts of gastrodia elata extract, 60 parts of ginkgo biloba extract, 40 parts of polygala tenuifolia extract and 30 parts of galangal extract; or
20 parts of ginseng, 60 parts of gastrodia elata, 60 parts of ginkgo biloba, 40 parts of polygala tenuifolia and 30 parts of galangal;
wherein the gastrodia elata is a monarch drug, the ginseng and the ginkgo leaves are ministerial drugs, the polygala tenuifolia and the galangal are assistant drugs, and the phosphatidylserine is a matched drug;
the preparation method of the traditional Chinese medicine composition for preventing and treating the Alzheimer disease comprises the following steps:
weighing the traditional Chinese medicinal materials according to the phosphatidylserine contained in the traditional Chinese medicinal composition for preventing and treating the Alzheimer disease and the traditional Chinese medicinal components;
soaking the weighed rhizoma gastrodiae, ginkgo leaf, polygala tenuifolia and galangal in a pharmaceutically acceptable solvent, extracting, and collecting an extracting solution; concentrating and drying the extracting solution, and mixing with phosphatidylserine and the crushed ginseng;
the solvent is water or ethanol water solution.
2. The traditional Chinese medicine composition according to claim 1, characterized in that: the extraction treatment is to boil the mixture after solvent extraction treatment for 0.5-2.0 h.
3. The traditional Chinese medicine composition according to claim 1, characterized in that: in the soaking treatment process, the weight ratio of the total weight of the Chinese medicinal materials to the solvent is 1 (6-15); and/or
The soaking time is more than 0h and less than or equal to 1 h.
4. The traditional Chinese medicine composition according to claim 1, characterized in that: the steps of the extraction process are repeated at least once.
5. The traditional Chinese medicine composition according to claim 1, characterized in that:
the temperature of the concentration treatment is 50-90 ℃; and/or
The drying treatment is spray drying treatment; wherein the spray drying treatment has a spray temperature of: 150 ℃ plus 210 ℃, and the outlet temperature is 60-99 ℃;
and sieving the crushed materials by a sieve of 60-200 meshes.
6. A medicine or health product for preventing and treating Alzheimer disease is characterized in that: comprising pharmaceutically acceptable excipients and an effective dose of the Chinese medicinal composition according to any one of claims 1 to 5.
7. The pharmaceutical or nutraceutical product of claim 6, wherein: the preparation form is any one of mixture, capsule, tablet, pill, powder or granule.
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| CN107281361A (en) * | 2017-06-14 | 2017-10-24 | 芜湖福民生物药业股份有限公司 | Chinese herbal granules and preparation method thereof |
| CN107158298A (en) * | 2017-06-14 | 2017-09-15 | 芜湖福民生物药业股份有限公司 | Chinese herbal granules and preparation method thereof |
| CN108902937B (en) * | 2018-06-11 | 2021-08-27 | 湖州维义生物科技股份有限公司 | Functional food for preventing senile dementia and preparation method thereof |
| CN111248439A (en) * | 2020-03-31 | 2020-06-09 | 唯思敦食品(上海)有限公司 | Health food for preventing and adjunctively treating Alzheimer's disease and preparation method thereof |
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