CN105920476A - Traditional Chinese medicine composition for prophylaxis and treatment of Alzheimer disease and preparation method thereof - Google Patents

Abstract

The invention discloses a traditional Chinese medicine composition for preventing and treating Alzheimer's disease and a preparation method thereof. The composition of the present invention contains 1 to 12 parts by weight of phosphatidylserine, and also contains the following traditional Chinese medicine components in parts by weight: 10 to 180 parts of ginseng, 10 to 200 parts of Gastrodia elata, 30 to 240 parts of ginkgo biloba, 10 to 200 parts of polygala, 10-120 parts of ginger; or 10-180 parts of ginseng and the following Chinese herbal medicine extracts: Gastrodia elata extract 10-200 parts, Ginkgo biloba extract 30-240 parts, polygala extract 10-200 parts and galangal extract 10-120 parts; or 10-180 parts of ginseng, 10-200 parts of Gastrodia elata, 30-240 parts of ginkgo biloba, 10-200 parts of polygala and 10-120 parts of galangal. The traditional Chinese medicine composition for preventing and treating Alzheimer's disease has the functions of nourishing the liver and nourishing the marrow, dredging collaterals and resolving phlegm, improving intelligence and invigorating the brain, etc. It can significantly improve memory and mild cognitive dysfunction in clinical practice, and has no toxic and side effects when taken for a long time.

Description

Traditional Chinese medicine composition for preventing and treating Alzheimer's disease and preparation method thereof

technical field

The invention belongs to the technical field of traditional Chinese medicine preparations, and in particular relates to a traditional Chinese medicine composition for preventing and treating Alzheimer's disease, a preparation method thereof, and medicines or health products containing the composition.

Background technique

China has entered an aging population society. Statistics show that by the end of 2014, China's elderly population over the age of 60 has reached 212 million, accounting for 15.5% of the total population. my country has become a large aging country in the world. According to reports, 10% of the elderly over the age of 65 in the world suffer from senile dementia, and the prevalence rate over the age of 80 is as high as 20%. Alzheimer's disease (Alzheimer's disease, referred to as AD) has become the fourth largest killer of human beings after heart disease, cancer and stroke. Epidemiological surveys show that there are at least 6 million senile dementia patients in my country, and the annual medical expenses are at least 30 billion yuan.

Modern medical research shows that the pathogenesis of Alzheimer's disease is extremely complex, involving multiple gene defects, environmental influences, neurotoxins, apoptosis, oxidative stress, β-AP (β-amyloid protein) aggregation, inflammatory response, Ca ^{2 +} Overload, cholinergic and other multi-system degeneration and other links and aspects. Aiming at the pathogenesis of Alzheimer's disease, currently on the market there are mainly cholinesterase inhibitors, glutamate receptor antagonists, calcium ion antagonists, free radical scavengers and antioxidants, estrogen and so on. Above-mentioned medicine is mainly based on chemical medicine, and toxic side effect is bigger. In 2010, the European "Guidelines on the Treatment of AD" pointed out that cholinesterase inhibitors are the first choice for AD drug treatment. But because AD requires long-term medication, and cholinesterase inhibitor drug resistance after long-term medication. In view of the limitations of the current Western medicine treatment effect on AD, adverse reactions and the complexity of the etiology of AD, the characteristics and advantages of traditional Chinese medicine are fully utilized, the overall comprehensive treatment, multi-link and multi-target play a role, so the development of safe and effective prevention and treatment New traditional Chinese medicine/health products for the treatment of Alzheimer's disease are imperative and imminent.

Existing patents have elaborated the etiology and pathogenesis of AD, but a systematic understanding has not yet been formed. For example, Chinese patent CN 105056151 A discloses a pill for treating Alzheimer's disease, which is made into a pill by combining the following Chinese medicine mass ratios: 15 parts of buffalo horn, 15 parts of rehmannia glutinosa, 20 parts of Achyranthes bidentata, 15 parts of calamus, 20 parts of turtle shell, 30 parts of calcined oyster, 15 parts of gardenia, 15 parts of turmeric, 15 parts of tangerine peel, 15 parts of ageratum, 10 parts of bamboo leaves, 15 parts of banlangen, and 15 parts of honeysuckle. Chinese patent CN 104997943A discloses a traditional Chinese medicine for the treatment of Alzheimer's disease, which is prepared from the following raw materials in the weight ratio: 10 parts of Chuiyuncao, 10 parts of Chen Hulu, Cimicifuga 10 parts, 18 parts of scutellaria, 18 parts of madder, 20 parts of vine, and 10 parts of caramel. Chinese patent CN 104069424 A discloses a traditional Chinese medicine for treating Alzheimer's disease, which is made of the following raw materials by weight: 5-20 parts of Morinda officinalis, 5-20 parts of Shichangpu, 5-20 parts of Curcuma 30 parts, Astragalus 5-30 parts, Polygala 1-20 parts.

In view of the in-depth research and improvement of understanding of AD in modern medicine, we provide the present invention based on years of clinical accumulation and scientific research verification.

Contents of the invention

The purpose of the present invention is to overcome the above-mentioned deficiencies in the prior art, provide a traditional Chinese medicine composition for preventing and treating Alzheimer's disease and its preparation method, so as to solve the technical problem that the curative effect of the existing treatment for preventing and treating Alzheimer's disease is not ideal.

Another object of the present invention is to provide a medicine or health product for preventing and treating Alzheimer's disease, so as to provide a product with definite curative effect for preventing and treating Alzheimer's disease.

In order to achieve the purpose of the above invention, on the one hand, the embodiment of the present invention provides a traditional Chinese medicine composition for preventing and treating Alzheimer's disease. The traditional Chinese medicine composition for preventing and treating Alzheimer's disease contains 1 to 12 parts by weight of phosphatidylserine, and also contains the following traditional Chinese medicine components by weight:

10-180 parts of ginseng, 10-200 parts of Gastrodia elata, 30-240 parts of ginkgo biloba, 10-200 parts of polygala, 10-120 parts of galangal; or

10-180 parts of ginseng and extracts of the following Chinese medicinal materials: 10-200 parts of gastrodia elata extract, 30-240 parts of ginkgo biloba extract, 10-200 parts of polygala 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 biloba, 10-200 parts of polygala and 10-120 parts of galangal.

Another aspect of the embodiments of the present invention provides a preparation method of a traditional Chinese medicine composition for preventing and treating Alzheimer's disease. The method comprises the steps of:

According to the phosphatidylserine contained in the traditional Chinese medicine composition for preventing and treating Alzheimer's disease of the present invention and the Chinese medicine components, each component of the Chinese medicinal materials is weighed;

pulverizing the weighed Chinese medicinal material and then mixing it with the phosphatidylserine component; or

The Chinese herbal medicines of gastrodia elata, ginkgo biloba, polygala, and galangal are soaked in a pharmaceutically acceptable solvent, then extracted, and the extract is collected; the extract is concentrated, dried, mixed with phosphatidylserine and crushed The processed ginseng is blended; or

The weighed Chinese medicinal material is soaked in a pharmaceutically acceptable solvent, then extracted, and the extract is collected; the extract is concentrated, dried, and then mixed with phosphatidylserine.

Another aspect of the embodiment of the present invention provides a drug or health product for preventing and treating Alzheimer's disease, including pharmaceutically acceptable excipients, and an effective dose of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease of the present invention or The traditional Chinese medicine composition for preventing and treating Alzheimer's disease prepared by the method for preparing the composition.

Compared with the prior art, the traditional Chinese medicine composition for preventing and treating Alzheimer's disease of the present invention uses Gastrodia elata as the monarch drug, ginseng and ginkgo leaf as the minister drug, polygala and galangal as the adjuvant drug (each medicinal material is a traditional Chinese medicinal material with the same origin of medicine and food) , safe and non-toxic, commonly used in health food and food), combined with phosphatidylserine, so that each component has a good preventive effect on Alzheimer's disease according to the role of monarchs and ministers. It has been proved by clinical trials that the composition of the present invention can improve Alzheimer's disease. The spatial learning ability and spatial exploration ability of Kunming mice with Haimer's disease can increase the RNA and Nissl body content of cerebral cortex and hippocampal pyramidal cells, and its effect shows a certain dose-effect relationship, improving brain nucleic acid metabolism and protein synthesis. Promote the regulation of RNA metabolism in the cerebral cortex and hippocampus, improve and regulate the metabolism of the entire neuron and the neuron structure in the key brain areas of learning and memory, and play a role in the prevention and treatment of Alzheimer's disease. Therefore, traditional Chinese medicine for the prevention and treatment of Alzheimer's disease The composition has the effects of invigorating the liver and nourishing the marrow, dredging collaterals and resolving phlegm, improving intelligence and strengthening the brain, etc., and can significantly improve memory and mild cognitive dysfunction in clinical practice.

In the preparation method of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease of the present invention, each component is processed according to fixed steps, thereby ensuring the quality of the composition, so that the obtained Chinese medicine composition for preventing and treating Alzheimer's disease has the functions of nourishing the liver and nourishing the marrow. , dredging collaterals and resolving phlegm, improving intelligence and strengthening the brain, etc., can significantly improve memory and mild cognitive impairment clinically, and has stable drug efficacy, safety and non-toxicity, controllable quality, low cost, and good industrialization feasibility.

Because the medicine or health food for preventing and treating Alzheimer's disease of the present invention contains the traditional Chinese medicine composition of the present invention in an effective dose, it has obvious effects such as nourishing the liver and nourishing the marrow, dredging collaterals and resolving phlegm, improving intelligence and strengthening the brain, etc., which can be clinically significant. Improve memory and mild cognitive impairment, prevent and treat Alzheimer's disease, and is safe and non-toxic.

detailed description

In order to make the object, technical solution and advantages of the present invention more clear, the present invention will be further described in detail below in conjunction with the examples. It should be understood that the specific embodiments described here are only used to explain the present invention, not to limit the present invention.

The weight of each component mentioned in the description of the embodiment of the present invention can not only refer to the specific content of each component, but also can represent the proportional relationship between the weights of each component. Therefore, as long as it is combined according to the description of the embodiment of the present invention The proportional expansion or reduction of the content of each component of the product is within the scope disclosed in the description of the embodiments of the present invention. Specifically, the parts by weight described in the description of the embodiments of the present invention can be μg, mg, g, kg and other well-known weight units in the medical field, and of course can be regarded as weight percentages.

From the perspective of traditional Chinese medicine, the basic pathogenesis of Alzheimer's disease is the loss of essence and marrow, the deficiency of qi and blood, the obstruction of brain collaterals by phlegm and fatigue, resulting in damage to the primordial spirit and the failure of mental mechanisms. The reason is that on the one hand, the viscera are weak and weak, the liver and kidney are deficient, and the brain is not nourished, which leads to the failure of mental mechanisms; The nature of the disease is nothing more than two kinds of deficiency and excess. Deficiency syndrome is related to the five internal organs, and the main responsibility is on the spleen and kidney, including the loss of kidney essence and spleen deficiency, but the deficiency of kidney essence is the main one; the excess syndrome is classified as internal organs. Qi, blood, and body fluids are not running smoothly, and for a long time, fatigue will be resolved, phlegm will form, numbness will block the brain, and the orifices will be blocked. At the same time, the two can influence each other, causing reality due to deficiency, and harming righteousness due to reality, followed by each other and becoming a disease, forming a syndrome of mixture of deficiency and excess. As far as this disease is concerned, the clinical treatment is often based on tonifying the kidney and resolving phlegm. On the basis of in-depth research on the pathogenesis, the present invention proposes to treat the liver from the perspective of tonifying the liver and nourishing the marrow, supplemented by promoting blood circulation and removing blood stasis, eliminating phlegm and resuscitation, and improving intelligence. Prescriptions and medicines such as Jiannao have achieved remarkable results in clinical observation for many years.

Based on the understanding of the basic pathogenesis of Alzheimer's disease, on the one hand, the embodiment of the present invention provides a traditional Chinese medicine composition for preventing and treating Alzheimer's disease. In one embodiment, the traditional Chinese medicine composition for preventing and treating Alzheimer's disease of the present invention contains 1-12 parts by weight of phosphatidylserine, and also contains the following Chinese medicine components by weight: 10-180 parts of ginseng, 10-200 parts of Gastrodia elata , 30-240 parts of Ginkgo biloba, 10-200 parts of polygala, 10-120 parts of galangal.

In another embodiment, the traditional Chinese medicine composition for preventing and treating Alzheimer's disease of the present invention contains 1 to 12 parts by weight of phosphatidylserine, and also contains the following Chinese medicine components by weight: 10 to 180 parts of ginseng and the following Chinese herbal extracts: Ingredients: 10-200 parts of Gastrodia elata extract, 30-240 parts of Ginkgo biloba extract, 10-200 parts of polygala extract and 10-120 parts of galangal extract.

In yet another embodiment, the traditional Chinese medicine composition for preventing and treating Alzheimer's disease of the present invention contains 1 to 12 parts by weight of phosphatidylserine, and also contains the following Chinese medicine components by weight: 10 to 180 parts of ginseng, 10 to 200 parts of Gastrodia elata 30-240 parts of Ginkgo biloba, 10-200 parts of polygala and 10-120 parts of galangal.

Therefore, the traditional Chinese medicine composition for preventing and treating Alzheimer's disease uses Gastrodia elata as the main drug, ginseng and ginkgo leaves as the ministerial drugs, polygala and galangal as the auxiliary drugs, and is combined with phosphatidylserine, which has a good preventive effect on Alzheimer's disease.

Among them, the monarch drug Gastrodia elata is sweet and flat in nature and taste, and enters the liver meridian. It has the effects of calming wind and convulsions, anti-rheumatism, anti-epileptic, anti-convulsant, sedative and antispasmodic, and is mainly used clinically to treat headache, dizziness, limb numbness, convulsions in children, epileptic convulsions and tetanus. Its main active ingredients are gastrodin, vanilla alcohol, vanilla aldehyde, p-hydroxybenzaldehyde and p-hydroxybenzyl alcohol, etc. Studies have shown that Gastrodia elata has the functions of dilating blood vessels, enhancing blood vessel elasticity, and improving blood supply of basilar artery; it can prevent and treat aging by repairing brain cell damage, protecting cerebral blood vessels, improving synaptic plasticity damage in the hippocampus, and inhibiting apoptosis of hippocampal nerve cells. dementia; increase brain blood perfusion, reduce cerebral ischemia-reperfusion injury, regulate the level of neurotransmitters, regulate the expression level of some aging-related genes and weaken the apoptosis pathway, and play a protective role in the brain; gastrodin and Gastrodia elata polysaccharide, promote Cellular immunity and humoral immunity fully exert the antioxidant effect, effectively remove lipid peroxides in serum, brain and other tissues, and increase the activity of various antioxidant enzymes. With the continuous deepening of its research, in recent years, it has been found that gastrodin can enter the brain through the blood-brain barrier, and rapidly decompose into gastrodin in the brain, blood and liver, and remain in the tissue in the form of gastrodin. It has the functions of scavenging free radicals, anti-oxidation, and inhibiting the apoptosis of central nervous cells, and has a certain curative effect on AD.

Ginseng, sweet in taste, slightly bitter, neutral in nature, returns to the lung, spleen, and heart channels. "Shen Nong's Materia Medica" listed ginseng as the top grade, saying that it "mainly nourishes the five internal organs, calms the spirit, calms the soul, relieves panic, improves eyesight, improves intelligence, and has the effect of lightening body and prolonging life after long-term use." Modern research has further expanded ginseng As a representative of tonic medicine, ginseng has been found in a large number of experiments and clinical studies that it has the effect of preventing and treating senile dementia. Physicians generally believe that ginseng and its compound preparations can prevent and treat senile dementia, mainly through methods such as nourishing qi and nourishing blood, tonifying kidney and replenishing essence, so that the memory, orientation and comprehension of senile dementia patients can be significantly improved. Studies have shown that ginseng prevents and treats Alzheimer's disease mainly through the following mechanisms: increasing the content of acetylcholine in the brain, promoting the synthesis of brain proteins and nucleic acids, improving the function of neurons in the hippocampus, antagonizing calcium overload, and promoting the development of brain nerve cells.

Ginkgo biloba, sweet, bitter, astringent, flat, heart-guiding, lung meridian, has the effects of promoting blood circulation and removing blood stasis, dredging collaterals to relieve pain, astringing the lungs to relieve asthma, astringent intestines to relieve diarrhea, and reducing turbidity and lipids. Its main component, ginkgo flavonoids, has the functions of expanding coronary arteries, improving coronary blood flow, relieving angina pectoris, lowering blood fat, resisting lipid oxidation, promoting cerebral blood flow and improving brain metabolism. Modern widely used in the treatment of hyperlipidemia, hypertension, coronary heart disease, angina pectoris, cerebral vasospasm, senile brain dysfunction, sequelae of brain injury and sequelae of stroke, etc. In the late 1980s, Germany, France and other countries successively developed various preparations of ginkgo leaf extract, and used modern pharmacological methods to study its pharmacological effects, and found a variety of active substances, such as: ginkgo flavonoid glycosides, ginkgolides and ginkgo Esters etc. Among them, ginkgo flavonoid glycosides can expand cerebral blood vessels, reduce cerebral vascular resistance, reduce capillary permeability, increase cerebral blood flow, and scavenge free radicals. Ginkgolide is a platelet activating factor antagonist, which can reduce blood viscosity and improve blood flow characteristics. Ginkgo biloba extract can significantly improve the symptoms of senile dementia, delay the aging process, scavenge free radicals, inhibit the cytotoxicity of β-amyloid protein, improve nerve cell degeneration, and treat and delay senile dementia, cognitive impairment, memory impairment, and language impairment , disorientation, affective disorder and other symptoms have obvious effects.

Phosphatidylserine is known as a new "smart nutrient" after choline and "brain gold" DHA. It is an active substance in cell membranes, especially in brain cells. It can improve the function of nerve cells, regulate the transmission of nerve impulses, and enhance the memory function of the brain. Because of its good lipophilicity, it can quickly enter the brain through the blood-brain barrier after absorption, soothe vascular smooth muscle cells, and increase blood supply to the brain. As people age, phosphatidylserine and other important chemical substances in the brain will gradually decrease, resulting in weakened memory and cognition. Appropriate supplementation of phosphatidylserine can increase the number of brain spurs, the fluidity of brain cell membranes and promote glucose metabolism in brain cells, thereby making brain cells more active, promoting concentration, and improving alertness and memory.

Gastrodia elata, ginseng, ginkgo biloba, polygala, and galangal are all approved by the Ministry of Health as raw materials for health food. Phosphatidylserine is a new resource food approved by the Ministry of Health in 2010. From the perspectives of traditional Chinese medicine conditioning and western medicine nutrition, the composition regulates and treats Alzheimer's disease in multiple levels, links and ways, has clear effects, is effective, safe and has no toxic or side effects.

As a preferred embodiment, 30-90 parts of ginseng, 30-100 parts of Gastrodia elata, 60-120 parts of ginkgo biloba, 30-100 parts of polygala, 30-100 parts of galangal contained in the above-mentioned traditional Chinese medicine composition for preventing and treating Alzheimer's disease 60 parts, 2 to 8 parts of phosphatidylserine.

In a specific embodiment, the above-mentioned traditional Chinese medicine composition for preventing and treating Alzheimer's disease contains 20 parts of ginseng, 60 parts of Gastrodia elata, 60 parts of ginkgo biloba, 40 parts of polygala, 30 parts of galangal, and 6 parts of phosphatidylserine.

By optimizing the compatibility content of each medicinal material component in the above-mentioned prescription, each component can play the role of the ruler and minister, and the compatibility of the prescription is further balanced, so that the traditional Chinese medicine composition for preventing and treating Alzheimer’s disease in the embodiment of the present invention has the functions of nourishing the liver and nourishing the marrow, dredging collaterals It can significantly improve memory and mild cognitive dysfunction clinically, thereby improving the efficacy of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease in the embodiment of the present invention. In addition, each medicinal material is a traditional Chinese medicinal material with the same origin as medicine and food, which is safe and non-toxic. It is commonly used in health food and food, so it has no toxic and side effects.

In addition, the extracts in the above embodiments can be obtained by extracting the corresponding Chinese medicinal materials in the prescription with a pharmaceutically acceptable solvent. In a preferred embodiment, the extraction treatment is an extraction treatment under boiling or hot boiling conditions of the solvent, and of course other acceptable extraction methods can also be used. In a specific embodiment, the extraction treatment time is 0.5-2.0 hours under the condition of solvent boiling or heat boiling. In another specific embodiment, the weight ratio of the total weight of the Chinese herbal medicine to the solvent is 1:(6-15); further, the soaking treatment time is 0-1.0h. Through the control of the process conditions, the control of the active ingredients and content of the extracted medicine can be realized, so as to endow the traditional Chinese medicine composition for preventing and treating Alzheimer's disease provided by the embodiment of the present invention with good clinical efficacy.

In another aspect, on the basis of the above-mentioned embodiments of the present invention, the embodiments of the present invention provide the following preparation methods of the above-mentioned 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's disease according to the embodiment of the present invention includes the following steps:

Step S01: According to the above-mentioned embodiment of the present invention, the traditional Chinese medicine composition for preventing and treating Alzheimer's disease contains ginseng, phosphatidylserine and the Chinese medicine components and weighs the Chinese medicinal materials of each component;

Step S02: The Chinese medicinal material weighed in step S01 is pulverized and then mixed with the phosphatidylserine component.

Wherein, the components contained in the traditional Chinese medicine composition for preventing and treating Alzheimer's disease described in the above step S01 and the content of each component are as described above, in order to save space, details are not repeated here.

The pulverization in the above step S02 can be pulverized according to conventional methods in the field of traditional Chinese medicine, such as pulverization according to the requirements of powders. In a specific embodiment, the pulverized mixture is passed through a 60-100 mesh sieve.

In another embodiment, the preparation method of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease according to the embodiment of the present invention includes the following steps:

Step S03: According to the above-mentioned embodiment of the present invention, the traditional Chinese medicine composition for preventing and treating Alzheimer's disease contains ginseng, phosphatidylserine and the Chinese medicine components and weighs the Chinese medicinal materials of each component;

Step S04: Soak the weighed Gastrodia elata, ginkgo leaves, polygala, and galangal Chinese medicinal materials in a pharmaceutically acceptable solvent, then extract and collect the extract; concentrate and dry the extract and mix with phosphatidylserine It is mixed with pulverized ginseng.

Wherein, the above-mentioned step S03 is the same as that described in the above-mentioned step S01, in order to save space, it will not be repeated here.

In the above step S04, the traditional Chinese medicinal materials of Gastrodia elata, ginkgo biloba, polygala, and galangal are soaked in a pharmaceutically acceptable solvent to infiltrate the raw materials of the traditional Chinese medicine so as to evaporate the effective functional components therein, and shorten the time of distillation treatment, thereby improving the efficiency . Distillation treatment is carried out directly after soaking treatment.

In one embodiment, in the step of soaking the weighed Gastrodia elata, ginkgo leaves, polygala, and galangal Chinese medicinal materials in a pharmaceutically acceptable solvent in step S04, the gastrodia elata, ginkgo leaves, polygala, and galangal traditional Chinese medicines The weight ratio of the total weight of the material to the solvent is 1:(6-15); or in a further embodiment, the time of the soaking treatment is 0-1.0h. The extraction amount and extraction rate can be improved by controlling the dosage of prescription components and solvents and the soaking time. In a specific embodiment, the immersion treatment is immersion treatment in a closed environment.

In one embodiment, the extraction process in step S04 is to perform heat treatment on the solvent mixture, such as heating to make the solvent boil for extraction process. In a further embodiment, the time of the 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, in the step S04, the Chinese medicinal materials of Gastrodia elata, Ginkgo biloba, Polygala, and Galangal are soaked in a pharmaceutically acceptable solvent and then extracted. The ginger Chinese medicinal material is added to the solvent, soaked in a closed environment, heated and boiled for 0.5-2.0 hours, and then filtered; the filter residue is added to the solvent for a second extraction of 0.5-2.0 hours by heating and boiling. Wherein, the weight ratio of the total weight of the gastrodia elata, ginkgo leaves, polygala, galangal Chinese medicinal materials to the solvent is but not only 1:(6-15); the time of the soaking treatment is but not only 0- 1.0h; adding the filter residue to the solvent is but not only adding the filter residue to the ratio of 1:(5-10) with the total weight of the gastrodia elata, ginkgo biloba, polygala, galangal Chinese medicinal materials and the weight ratio of the solvent Add to the vehicle.

In each of the above embodiments, the solvent in step S04 is water or ethanol water. The selection of this type of solvent can not only effectively extract the effective ingredients of the medicine, but also make the extracted extract safe and low in cost.

In the above step S04, the concentration treatment is to remove part or all of the extraction solvent. In one embodiment, the temperature of the concentration treatment is controlled at 50-99°C. The concentration treatment at this temperature can not only prevent the active ingredients of the drug from being destroyed or volatilized, resulting in a decrease in drug efficacy, but also effectively remove part or all of the solvent. Concentration treatment is preferably to use reduced pressure concentration, on the one hand, it can avoid high temperature and cause some functional components to be decomposed and become invalid; on the other hand, it can effectively accelerate the volatilization of water and shorten the time of concentration treatment.

In the step S04, the above-mentioned drying treatment may be a conventional drying method in the field without destroying or volatilizing the extracted active ingredients. In one description, the drying treatment is spray drying treatment; wherein, the spray temperature of the spray drying treatment is: 150-210°C, and the outlet temperature is 60-99°C.

In the step S04, the crushed ginseng is passed through a 60-200 mesh sieve.

The mixing process in the step S04 is to make the components mix uniformly, therefore, the mixing process can be a conventional mixing process in the field that can achieve this purpose.

In yet another embodiment, the preparation method of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease according to the embodiment of the present invention includes the following steps:

Step S05: According to the above-mentioned embodiment of the present invention, the traditional Chinese medicine composition for preventing and treating Alzheimer's disease contains ginseng, phosphatidylserine and the Chinese medicine components and weighs the Chinese medicinal materials of each component;

Step S06: Soak the weighed Chinese herbal medicine in a pharmaceutically acceptable solvent, then extract it, and collect the extract; concentrate and dry the extract, then mix it with phosphatidylserine.

Wherein, the above-mentioned step S05 is the same as that described in the above-mentioned step S01, in order to save space, it will not be repeated here.

The soaking treatment, extraction treatment, extraction solution concentration treatment and drying treatment in the above step S06 are all the same as the soaking treatment, extraction treatment, extraction solution concentration treatment and drying treatment described in the above step S06. repeat.

Therefore, in the preparation method of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease in the embodiment of the present invention, each component is processed according to fixed steps, thereby ensuring the quality of the composition, making the content of the extracted active ingredients stable, and making the obtained anti-Alzheimer's disease The traditional Chinese medicine composition for Haimer's disease has stable efficacy, is safe and non-toxic, and has controllable quality. The cost is low and the industrialization feasibility is good.

In another aspect, the embodiment of the present invention provides a medicine or health food for preventing and treating Alzheimer's disease on the basis of the above traditional Chinese medicine composition for preventing and treating Alzheimer's disease and its preparation method. In one embodiment, the drug or health food for preventing and treating Alzheimer's disease according to the embodiment of the present invention includes pharmaceutically acceptable excipients, and also includes an effective dose of the above-mentioned traditional Chinese medicine combination for preventing and treating Alzheimer's disease according to the embodiment of the present invention or the 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 according to the embodiment of the present invention.

Wherein, the effective dose of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease refers to the therapeutically effective dose, which refers to the amount of the compound of the present invention that is sufficient to show benefit or clinical significance to the individual. It will be appreciated by those skilled in the art that the actual amount or dose administered and the schedule of administration will depend on the nature and severity of the disease being treated, the age and general condition of the subject being treated, the mode of administration, and the like.

In one embodiment, the pharmaceutically acceptable excipients contained in the drug or health food for preventing and treating Alzheimer's disease of the present invention refer to any excipients known by those skilled in the art to be suitable for a specific mode of administration. As 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 benefit from the prevention and treatment of Alzheimer's disease or enhance the activity of the above-mentioned traditional Chinese medicine composition for preventing and treating Alzheimer's disease.

It should be understood that the above-mentioned adjuvants should be non-toxic, not interfere with or impair the efficacy of the above-mentioned traditional Chinese medicine composition for preventing and treating Alzheimer's disease in the embodiment of the present invention. In addition, the selection of the excipient can be flexibly selected according to the dosage form of the drug or health food for preventing and treating Alzheimer's disease in the above-mentioned embodiments.

In addition, the above-mentioned drugs or health foods for preventing and treating Alzheimer's disease can be administered alone, or in combination with other compositions if necessary.

In one embodiment, according to the administration mode of the drug or health food for preventing and treating Alzheimer's disease in the above-mentioned embodiments of the present invention, pharmaceutically acceptable excipients and an effective dose of traditional Chinese medicine composition for preventing and treating Alzheimer's disease can be flexibly selected to prepare Different dosage forms, such as any dosage form in mixture, oral liquid, capsule, tablet, pill, powder, powder or granule.

Therefore, the medicine or health product for preventing and treating Alzheimer's disease in the embodiments of the present invention contains the effective dose of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease described above. Therefore, the embodiment of the present invention prevents and treats Alzheimer's disease. The medicine or health care product has obvious efficacy in preventing and treating Alzheimer's disease, has no toxic and side effects after long-term administration, and has good clinical compliance.

The present invention will be further described below through specific examples of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease and its preparation method.

Example 1

This embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer's disease and its preparation method. The prescription of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease contains 50 parts of gastrodia elata, 170 parts of ginseng, 120 parts of ginkgo biloba, 60 parts of polygala, 30 parts of galangal and 6 parts of phosphatidylserine.

The preparation method of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease in this example:

S11: Gastrodia elata, ginseng, ginkgo biloba, polygala, galangal, and phosphatidylserine are taken according to the ratio;

S12: Ginseng is crushed separately through a 60-mesh sieve, and the ginseng powder is used for later use; the rest of the traditional Chinese medicine is mixed, and extracted twice with water. For the first time, add 12 times the amount of water, boil for 1.5 hours, and add 8 times the amount of water for the second time, and boil for 1 hour. , combined two extracts;

S13: filter the extract, concentrate under reduced pressure to a relative density of about 1.10; spray dry, add phosphatidylserine and ginseng powder to the spray dried powder, and obtain a traditional Chinese medicine composition for preventing and treating Alzheimer's disease.

Example 2

This embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer's disease and its preparation method. The prescription of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease contains 150 parts of gastrodia elata, 60 parts of ginseng, 40 parts of ginkgo biloba, 20 parts of polygala, 60 parts of galangal and 10 parts of phosphatidylserine.

The preparation method of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease in this example:

S21: Gastrodia elata, ginseng, ginkgo biloba, polygala, galangal, and phosphatidylserine are taken according to the metering ratio;

S22: Chinese herbal medicines were mixed and refluxed with 70% ethanol for extraction. For the first time, 12 times the amount of 70% ethanol was added for 1.5 hours, and for the second time, 8 times the amount of 70% ethanol was added for 1 hour, and the two extracts were combined;

S23: concentrating the extract under reduced pressure, drying under reduced pressure, and pulverizing the dry extract; adding phosphatidylserine.

Example 3

This embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer's disease and its preparation method. The prescription of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease contains 10 parts of Gastrodia elata, 180 parts of ginseng, 240 parts of ginkgo biloba, 100 parts of polygala, 20 parts of galangal and 1 part of phosphatidylserine.

The preparation method of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease in this example:

S31: Gastrodia elata, ginseng, ginkgo biloba, polygala, galangal, and phosphatidylserine are taken according to the metering ratio;

S31: Ginseng is crushed separately and passed through a 200-mesh sieve, and the ginseng powder is used for later use; mix the remaining Chinese medicinal materials, add water to extract twice, add 15 times the amount of water for the first time, boil for 2.0 hours, add 10 times the amount of water for the second time, and boil for extraction 1.5 hours, combine two extracts;

S33: Concentrate the extract, dry it under reduced pressure, pulverize the dry extract, add ginseng fine powder and phosphatidylserine for mixing treatment.

Example 4

This embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer's disease and its preparation method. The prescription of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease contains 60 parts of Gastrodia elata, 20 parts of ginseng, 60 parts of ginkgo biloba, 40 parts of polygala, 30 parts of galangal and 6 parts of phosphatidylserine.

The preparation method of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease in this example:

S41: Gastrodia elata, ginseng, ginkgo biloba, polygala, galangal, and phosphatidylserine are taken according to the ratio;

S42: Ginseng is crushed separately and passed through an 80-mesh sieve, and the ginseng powder is used for later use; the rest of the Chinese herbal medicines are mixed, and extracted twice by adding water. For the first time, add 10 times the amount of water, boil for 1.5 hours, and add 8 times the amount of water for the second time, boil for 1.0 hour, combined two extracts;

S43: the extract is concentrated and spray-dried; the spray-dried powder is mixed with phosphatidylserine and ginseng powder.

Example 5

This embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer's disease and its preparation method. The prescription of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease contains 140 parts of Gastrodia elata, 10 parts of ginseng, 30 parts of ginkgo biloba, 80 parts of polygala, 60 parts of galangal and 7 parts of phosphatidylserine.

The preparation method of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease in this example:

S51: Gastrodia elata, ginseng, ginkgo biloba, polygala, galangal, and phosphatidylserine are taken according to the ratio;

S51: Mix Chinese herbal medicines and add water to extract twice, add 12 times the amount of water for the first time, boil for 2.0 hours for extraction, add 8 times the amount of water for the second time, boil for 1.0 hours for extraction, and combine the two extracts;

S53: Concentrate the extract, spray dry; add phosphatidylserine and mix well.

Example 6

This embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer's disease and its preparation method. The prescription of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease contains 30 parts of gastrodia elata, 10 parts of ginseng, 40 parts of ginkgo biloba, 40 parts of polygala, 40 parts of galangal and 12 parts of phosphatidylserine.

The preparation method of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease in this example:

S61: Gastrodia elata, ginseng, ginkgo biloba, polygala, galangal, and phosphatidylserine are taken according to the ratio;

S62: Chinese herbal medicines are pulverized and passed through an 80-mesh sieve; phosphatidylserine is added and mixed evenly to obtain a finished powder.

Example 7

This embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer's disease and its preparation method. The prescription of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease contains 180 parts of gastrodia elata, 70 parts of ginseng, 70 parts of ginkgo biloba, 200 parts of polygala, 60 parts of galangal and 3 parts of phosphatidylserine.

Clinical Trials

1. Test unit

Shenzhen Institute of Gerontology.

2. Purpose of the experiment

To study the function of preventing and treating Alzheimer's disease and improving memory of the composition of the present invention.

3. Experimental materials

Sample 1 is provided by Shenzhen Institute of Gerontology (prepared the gained Chinese medicine composition according to embodiment 4, adds auxiliary material and is prepared into tablet), outward appearance is brown sheet, and human oral recommended dosage is 0.8g/ sheet, each 3, each 3 times a day, based on the weight of 60kg per person, the equivalent dose is 0.12g/kg.bw.

The Chinese medicine composition is provided by Shenzhen Institute of Gerontology (according to the formula in Example 4, deducting phosphatidylserine, and the rest are prepared according to Example 4), the appearance is a brown tablet, and the recommended oral dose for human body is 0.75g/ tablet, each time 3 tablets, 3 times a day, based on the weight of 60kg per person, the equivalent dose is 0.11g/kg.bw.

Phosphatidylserine is provided by Shaanxi TPV Biotechnology Co., Ltd. The recommended dosage for human oral administration is 600mg/day, calculated on the basis of a 60kg human body weight, and the equivalent dose is 10mg/kg.bw.

Huperzine A tablets are provided by Simcere Pharmaceutical Co., Ltd., 0.05mg/tablet, 4 tablets at a time, twice a day, calculated on the basis of 60kg body weight per person, the equivalent dose is 0.007mg/kg.bw.

4. Experimental method

4.1 Dose setting

The dosage settings of each sample are shown in Table 1. The samples of each dosage group were dissolved and diluted to a suitable volume for gavage.

Table 1 Dosage converted by body weight

4.2 Test method

4.2.1 Animal experiments on learning and memory behavior

After 3 days of adaptive feeding, the animals began to be observed in groups. The experiment was divided into two batches of memory acquisition disorder model and memory reproduction disorder model. Each batch of experimental animals used 80 animals. The mice were randomly divided into normal control group, model control group, sample 1 high, medium and low dose groups, and Chinese medicine composition group. , phosphatidylserine group, huperzine A group, 10 rats in each group, given the corresponding preparations by gavage according to the grouping situation, once a day, for 7 consecutive days.

4.2.1.1 Preparation and test of memory acquisition impairment model Scopolamine (3 mg/kg, ip) was used to prepare memory acquisition impairment model. The experimental animals were continuously given the corresponding test substance for 30 days according to the grouping situation. After giving the test substance for 30 minutes on the 30th day, the model control group, sample 1 high, medium and low dose groups, Chinese medicine composition group, phosphatidylserine group, huperzine A Both groups were intraperitoneally injected with scopolamine (3mg/kg), and started platform training 10 minutes later. After giving the test substance for 30 minutes on the 31st day, the memory performance was tested by the platform method.

4.2.1.2 Preparation of memory reproduction disorder model and group test 40% ethanol (0.1mL/10g, ig) was used to prepare memory reproduction disorder model. The experimental animals were continuously given the corresponding test substance for 30 days according to the grouping situation, and after the test drug was given for 30 minutes on the 30th day, the training of avoiding the dark method was carried out. After 30 minutes of giving the test substance on the 31st day, the model control group, the sample 1 high, middle and low dose groups, the Chinese medicine composition group, the phosphatidylserine group, and the huperzine A group all used the amount of 40% ethanol 0.1mL/10g body weight After gavage, test the memory score after 30 minutes.

4.2.1.3 Platform jumping test Put the mouse in the platform diving apparatus, and after adapting to the environment for 5 minutes, put it on the platform lightly. When the animal jumps off the platform and touches the copper grid with its limbs, it will be stimulated with 40V AC voltage. The normal response of mice is to jump back to the platform to avoid the noxious stimulus. Animals may jump off the platform again or multiple times, only to jump back to the platform after being shocked. The number of times the mouse jumped off the platform and touched the copper grid was recorded as the number of errors, and it was trained like this for 5 minutes. After 24 hours, the test of memory scores was carried out. Put the mice on the platform, and record the latency (SL) of staying on the safe platform and the number of electric shocks (number of errors) within 3 minutes. If the mice stay on the platform for more than 3 minutes, the latency is calculated as 180s.

4.2.1.4 Dark avoidance test Train the mice 30 minutes after the last administration, put the mice face away from the hole into the light room, and start the timer. Animals enter the darkroom through the hole and receive electric shocks, and the timing stops automatically. Take out the mouse, record the time required for the mouse to encounter the electric shock from being placed in the light room into the dark room, which is the incubation period. The test was repeated after 24 hours, and the incubation period of each animal entering the darkroom and the number of electric shocks for 5 minutes were recorded (for those who did not enter the darkroom within 5 minutes, the incubation period was calculated as 300s).

4.2.2 Quantitative detection of RNA and Nissl bodies in relevant brain regions

4.2.2.1 After taking slices, administering observations and learning and memory testing, in the dark avoidance experiment, 8 mice were randomly selected from each group, anesthetized with 1% pentobarbital sodium (40mg/Kg body weight, intraperitoneal injection) for thoracotomy, left ventricle The aortic cannula was ligated, rinsed with 50 mL of normal saline, and then fixed with cold paraformaldehyde glutaraldehyde perfusion fixative solution. The brain was fixed in the perfusion solution for 2 hours (4°C), and then injected with 20% sucrose buffer (0.1M, pH 7.4) for 24h (4°C), the crowns were sliced serially with an AO cryostat, with a slice thickness of 30 μm, and the slices were collected in 0.1 MPBS for use.

4.2.2.2 Incubation and production

4.2.2.2.1 Use the Elias method for RNA histochemical staining: slide the slices down into water; enter the staining solution (10 mL of 0.5% methyl green plus 20 mg of guanoin Y) in a constant temperature incubator at 37°C for 1 hour; wash with distilled water at 0°C-2°C for 2 minutes; Wash with tert-butanol; dehydrate with tert-butanol twice, 3 min each time; mount with xylene transparent neutral gum (for the comparison photo, use RNase solution (8mg RNase dissolved in 10mL distilled water) to digest at 37°C for 1 hour and then enter the dye solution).

4.2.2.2.2 Nissl body staining Degreasing the sections into xylene twice, 3 minutes each time, descending to water; 1% tar violet staining solution at 37°C for 10 minutes; 70% ethanol 3 times, 1 min each time; 95% ethanol 3 times, 1 min /time; 3 times with absolute ethanol, 1min/time; 2 times with xylene transparent, 5min/time; seal with neutral gum.

4.2.2.2.3 Quantitative detection Quantitative analysis uses LM ZEISS Axiotron research microscope, JVCKY-F30B3-CCD Variocam cryo-camcorder and Kontron IBAS 2.0 automatic image analyzer. For the measurement area of the cerebral cortex, the layer III of the temporal lobe cortex, that is, the outer pyramidal cell layer, is selected. The pyramidal cells in the CA1 area of the hippocampus are measured. The corrected OD value (COD) was obtained by subtracting the background OD value from the background OD value, that is, the actual optical density of the reaction product. Three slices were randomly selected for each index in each case, and three fields of view were randomly measured on each slice in the measurement area, and all measurements were performed under the same optical conditions. Next complete.

4.3 Test data statistics

The data are represented by mean ± standard deviation (mean ± SD), and SPSS17.0 software is used for statistics, and group t test is used for comparison between groups. When P<0.05, it means that there is a significant difference between groups.

5. Experimental results

5.1 Effect of the composition on the learning and memory behavior of model mice

5.1.1 Effect of the composition on the incubation period and the number of errors in the mouse platform test

As can be seen from Table 2, compared with the model group, the platform jumping latency of mice in each administration group was extended to a certain extent, and the number of mistakes was reduced. Among them, the sample 1 high, medium dose group, Chinese medicine composition group and huperzine A group Compared with the model group, the latency and the number of errors were significantly different (P<0.05). The results show that the composition, the traditional Chinese medicine composition and huperzine A can significantly promote the acquisition of memory.

Analysis of the nature of the interaction, the analysis of the medium dose group, the Chinese medicine composition group and the phosphatidylserine group of sample 1, the combination of the Chinese medicine composition and phosphatidylserine, the effect is better than the two alone, and there is a synergistic effect between the two The effect of (E _{sample 1 dosage group} >E _{traditional Chinese medicine composition} +E _{phosphatidylserine} ).

The impact of table 2 composition on mouse platform test latency and the number of times of error ( n=10)

(Model of Memory Acquisition Disorders)

Note: Compared with the normal group, *P<0.05; compared with the model group, #P<0.05

5.1.2 Effect of the composition on the incubation period and the number of errors in the dark avoidance test of mice

It can be seen from Table 3 that compared with the model group, the dark avoidance latency of the mice in each administration group was extended to a certain extent, and the number of mistakes was reduced. Among them, compared with the model group, the incubation period of sample 1 high, medium and low dose groups, traditional Chinese medicine composition group, phosphatidylserine group and huperzine A group had statistical significance (P<0.05); Compared with the model group, the error times of the dosage group, the traditional Chinese medicine composition group and the huperzine A group had statistical significance (P<0.05). The results show that the composition, the traditional Chinese medicine composition, phosphatidylserine and huperzine A can significantly promote the memory reproduction process.

The nature of the interaction was analyzed by analyzing the medium dose group, the traditional Chinese medicine composition group and the phosphatidylserine group of sample 1. The combination of the Chinese medicine composition and phosphatidylserine can prolong the dark avoidance latency better than the two alone, and both There is a synergistic effect ( _{dose group in E sample 1} >E _{traditional Chinese medicine composition} +E _{phosphatidylserine} ).

The impact of table 3 composition on mouse dark avoidance test latency and the number of times of error ( n=10)

(Memory Reproduction Impairment Model)

Note: Compared with the normal group, *P<0.05; compared with the model group, #P<0.05

5.2 Qualitative and quantitative analysis of RNA and Nissl bodies in the relevant brain regions of model mice by the composition

It can be seen from the results in Table 4 that the content of RNA and Nissl bodies in normal mouse neurons, especially cortical and hippocampal pyramidal neurons, is very rich, indicating that the metabolism of related neurons is vigorous, and the content of RNA and Nissl bodies in the model group is significantly reduced, indicating that their cells There is an obstacle in metabolism, and each dose group of sample 1 can increase the content of RNA and Nissl bodies in the temporal lobe cortex and hippocampal pyramidal cells of model mice to varying degrees, indicating that the composition can significantly improve nucleic acid metabolism and protein synthesis in senile dementia mice, and In this way, the metabolism of the whole neuron can be improved and regulated, so as to prevent and treat Alzheimer's disease.

The influence of table 4 composition on model mouse temporal lobe cortex outside and hippocampus CA1 region vertebral body cell RNA, Nissl body content ( n=8)

Note: Compared with the normal group, *P<0.05; compared with the model group, ##P<0.01, #P<0.05

From the above experimental results, it can be seen that the traditional Chinese medicine composition for preventing and treating Alzheimer's disease provided by the embodiment of the present invention can improve the spatial learning ability and spatial exploration ability of Kunming mice with Alzheimer's disease, and increase the number of cerebral cortex and hippocampal pyramidal cells. The content of RNA and Nissl body, and its role shows a certain dose-effect relationship, improve brain nucleic acid metabolism and protein synthesis metabolism, promote the regulation of RNA metabolism in the cerebral cortex and hippocampus, improve and regulate the metabolism of the entire neuron and the key brain of learning and memory The neuron structure of the region plays a role in the prevention and treatment of Alzheimer's disease.

The above descriptions are only preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present invention should be included in the protection of the present invention. within range.

Claims (10)

1. A traditional Chinese medicine composition for preventing and treating Alzheimer's disease, characterized in that it contains 1 to 12 parts by weight of phosphatidylserine, and also contains the following Chinese medicine components by weight: 10-180 parts of ginseng, 10-200 parts of Gastrodia elata, 30-240 parts of ginkgo biloba, 10-200 parts of polygala, 10-120 parts of galangal; or 10-180 parts of ginseng and extracts of the following Chinese medicinal materials: 10-200 parts of gastrodia elata extract, 30-240 parts of ginkgo biloba extract, 10-200 parts of polygala 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 biloba, 10-200 parts of polygala and 10-120 parts of galangal. 2. The traditional Chinese medicine composition according to claim 1, characterized in that 30-100 parts of gastrodia elata, 30-90 parts of ginseng, 60-120 parts of ginkgo biloba, 30-100 parts of polygala, 30-60 parts of galangal , 2 to 8 parts of phosphatidylserine. 3. The traditional Chinese medicine composition according to claim 1, characterized in that 60 parts of Gastrodia elata, 20 parts of ginseng, 60 parts of ginkgo biloba, 40 parts of polygala, 30 parts of galangal, and 6 parts of phosphatidylserine. 4. A preparation method of a traditional Chinese medicine composition for preventing and treating Alzheimer's disease, characterized in that, comprising the steps of: According to any one of claims 1-3, the phosphatidylserine contained in the traditional Chinese medicine composition for preventing and treating Alzheimer's disease and the Chinese medicine components are weighed for each component of Chinese medicinal materials; pulverizing the weighed Chinese medicinal material and then mixing it with the phosphatidylserine component; or The Chinese herbal medicines of gastrodia elata, ginkgo biloba, polygala, and galangal are soaked in a pharmaceutically acceptable solvent, then extracted, and the extract is collected; the extract is concentrated, dried, mixed with phosphatidylserine and crushed. of ginseng for blending treatment; or The weighed Chinese medicinal material is soaked in a pharmaceutically acceptable solvent, then extracted, and the extract is collected; the extract is concentrated, dried, and then mixed with phosphatidylserine. 5 . The preparation method according to claim 4 , characterized in that: the extraction treatment is to boil the mixture after the solvent leaching treatment for 0.5-2.0 hours. 6. The preparation method according to claim 4 or 5, characterized in that: in the soaking process, the weight ratio of the total weight of the Chinese herbal medicine to the solvent is 1:(6-15); and /or The soaking treatment time is 0-1.0h. 7. The preparation method according to claim 4 or 5, characterized in that: the step of the extraction treatment is repeated at least once. 8. according to the preparation method described in any one of claim 4,5, it is characterized in that: described solvent is water or ethanol aqueous solution; And/or The temperature of the concentration treatment is 50-90°C; and/or The drying treatment is spray drying treatment; wherein, the spray temperature of the spray drying treatment is: 150-210°C, and the outlet temperature is 60-99°C. Said crushed powder passes through a 60-200 mesh sieve. 9. A medicine or health care product for preventing and treating Alzheimer's disease, comprising pharmaceutically acceptable adjuvants, characterized in that: it also includes an effective dose of the Chinese medicine composition described in claims 1-3 or by claim 4-8 The traditional Chinese medicine composition prepared by any one of the described preparation methods. 10. The medicine or health product according to claim 9, characterized in that: the dosage form is any dosage form in mixture, capsule, tablet, pill, powder, powder or granule.