CN105920476B - Traditional Chinese medicine composition for preventing and treating Alzheimer's 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 invention contains 1-12 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 radix, Gao Liang 10-120 parts of ginger; or 10-180 parts of ginseng and the following Chinese herbal medicine extracts: 10-200 parts of gastrodia elata extract, 30-240 parts of ginkgo biloba extract, 10-200 parts of polygala extract and galangal extract 10 to 120 parts; or 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 and 10 to 120 parts of galangal extracts. The traditional Chinese medicine composition for preventing and treating Alzheimer's disease has the functions of invigorating the liver and nourishing marrow, dredging collaterals and resolving phlegm, invigorating intelligence and invigorating brain, etc., can clinically significantly improve memory and mild cognitive impairment, 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, in particular to a traditional Chinese medicine composition for preventing and treating Alzheimer's disease, a preparation method thereof, and a medicine or health care product containing the composition.

Background technique

China has entered an aging society. Statistics show that by the end of 2014, China's elderly population over the age of 60 had reached 212 million, accounting for 15.5% of the total population. my country has become the world's largest aging country. According to reports, 10% of the elderly over the age of 65 in the world suffer from Alzheimer's disease, and the prevalence over the age of 80 is as high as 20%. Alzheimer's disease (AD) has become the fourth leading cause of death 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 has shown that the pathogenesis of Alzheimer's disease is extremely complex, involving multiple gene defects, environmental influences, neurotoxins, apoptosis, oxidative stress, β-AP (β-amyloid) aggregation, inflammatory response, Ca ^{2 +} Multiple links and aspects such as overload, cholinergic and other multi-system degeneration. Aiming at the pathogenesis of Alzheimer's disease, there are mainly cholinesterase inhibitors, glutamate receptor antagonists, calcium ion antagonists, free radical scavengers and antioxidants, estrogens and so on on the market. The above-mentioned drugs are mainly chemical drugs, and the toxic and side effects are relatively large. The 2010 European "Guidelines for AD Treatment" pointed out that cholinesterase inhibitors are the first choice for AD drug treatment. However, because AD requires long-term medication, and cholinesterase inhibitors are resistant to long-term use. In view of the current limitations of western medicine on AD treatment effect, adverse reactions and the complexity of AD etiology, we should give full play to the characteristics and advantages of traditional Chinese medicine, comprehensively regulate the whole, and play a role in multiple links and multiple targets. It is imperative and imminent to develop new traditional Chinese medicines/health products for the treatment of Alzheimer's disease.

Existing patents have described the etiology and pathogenesis of AD, but have not yet formed a systematic understanding. For example, Chinese patent CN105056151 A discloses a pill for the treatment of Alzheimer's disease, which is made into pills according to the following mass ratios of each traditional Chinese medicine: 15 parts of buffalo horn, 15 parts of Shudi, 20 parts of Achyranthes, and calamus 15 parts, turtle shell 20 parts, calcined oysters 30 parts, gardenia 15 parts, turmeric 15 parts, tangerine peel 15 parts, Huoxiang 15 parts, bamboo leaves 10 parts, Banlangen 15 parts, honeysuckle 15 parts. Chinese patent CN104997943 A discloses a traditional Chinese medicine for the treatment of Alzheimer's disease, which is prepared from the following raw medicinal materials by weight: 10 parts of Bingyuncao, 10 parts of Chenhu Lupo, Cimicifuga 10 parts, 18 parts of shield-winged vine, 18 parts of madder, 20 parts of nocturnal vine, 10 parts of galangal incense. In Chinese patent CN 104069424 A, a traditional Chinese medicine for treating Alzheimer's disease is disclosed. 30 servings, 5-30 servings of Astragalus, 1-20 servings of Yuanzhi.

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

SUMMARY OF THE INVENTION

The purpose of the present invention is to overcome the above-mentioned deficiencies of the prior art, and to provide a traditional Chinese medicine composition for preventing and treating Alzheimer's disease and a preparation method thereof, so as to solve the technical problem of less than ideal therapeutic efficacy for preventing and treating Alzheimer's disease.

Another object of the present invention is to provide a medicine or health care 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 above purpose of the invention, one aspect of the embodiments 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 1-12 parts by weight of phosphatidylserine, and also contains the following traditional Chinese medicine components by weight:

10-180 servings of ginseng, 10-200 servings of Gastrodia elata, 30-240 servings of Ginkgo biloba, 10-200 servings of Polygalaceae, 10-120 servings of Galangal; or

10-180 parts of ginseng and the following Chinese herbal medicine extracts: 10-200 parts of Gastrodia elata extract, 30-240 parts of Ginkgo biloba extract, 10-200 parts of Polygala radix 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 japonica and 10-120 parts of galangal extracts.

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 includes the following steps:

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

After the weighed Chinese medicinal material is pulverized, it is mixed with the phosphatidylserine component; or

The weighed Chinese medicinal materials of Gastrodia elata, Ginkgo biloba, Polygala Radix, and Galangal are soaked in a pharmaceutically acceptable solvent and subjected to extraction treatment, and the extract is collected; The processed ginseng is blended; or

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

In yet another aspect of the embodiments of the present invention, there is provided a medicine or health care 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 present invention. The traditional Chinese medicine composition for preventing and treating Alzheimer's disease is prepared by the composition preparation method.

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 medicine, ginseng and ginkgo biloba as the minister medicine, and Polygala radix and galangal as the auxiliary medicine (each medicinal material is a 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 prevention and treatment effect on Alzheimer's disease according to the role of monarch, minister and assistant. 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 Hemer's disease increased the content of RNA and Nissl bodies in cerebral cortex and hippocampal pyramidal cells, and their effects showed a certain dose-effect relationship, improving brain nucleic acid metabolism and protein synthesis and metabolism, 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 regions 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 functions of nourishing the liver and nourishing the marrow, dredging collaterals and resolving phlegm, nourishing intelligence and invigorating the brain, etc., and can significantly improve memory and mild cognitive impairment in clinical practice.

The preparation method of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease of the present invention processes each component according to fixed steps, thereby ensuring the quality of the composition, so that the obtained traditional Chinese medicine composition for preventing and treating Alzheimer's disease has the functions of nourishing the liver and nourishing the marrow. It can significantly improve memory and mild cognitive impairment in clinical practice, and has stable efficacy, safety and non-toxicity, controllable quality, low cost and good industrialization feasibility.

Since the medicine or health food for preventing and treating Alzheimer's disease of the present invention contains an effective dose of the traditional Chinese medicine composition of the present invention, it has obvious effects such as nourishing the liver and nourishing marrow, clearing the collaterals and resolving phlegm, nourishing intelligence and strengthening the brain, etc., and can be clinically significant. It can improve memory and mild cognitive impairment, and prevent and treat Alzheimer's disease. It is safe and has no toxic side effects.

Detailed ways

In order to make the objectives, technical solutions and advantages of the present invention clearer, the present invention will be further described in detail below with reference to the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention, but 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 the components. Therefore, as long as it is combined according to the description of the embodiment of the present invention The content of each component of the compound is proportionally enlarged or reduced within the scope disclosed in the description of the embodiments of the present invention. Specifically, the weight part described in the description of the embodiment of the present invention may be a known weight unit in the medical field such as μg, mg, g, kg, etc., and of course can be regarded as a weight percentage.

From the perspective of traditional Chinese medicine, the basic pathogenesis of Alzheimer's disease is the deficiency of essence and marrow, deficiency of qi and blood, phlegm fatigue and obstruction of the brain and collaterals, resulting in damage to the primordial spirit and ineffectiveness of the spiritual machine. The reason is that on the one hand, the viscera is deficient, the liver and kidney are deficient, and the brain and marrow are out of nourishment, which leads to the loss of spiritual functions; The disease is nothing but deficiency and excess. The deficiency syndrome is related to the five internal organs, and the main responsibility lies in the spleen and kidney, including the deficiency of kidney essence and the insufficiency of the spleen. Qi, blood and body fluid run poorly, and for a long time, it will reduce fatigue, form phlegm, block the brain collaterals, and close the orifices. At the same time, the two can influence each other, because the deficiency leads to the reality, because the reality hurts the positive, and then they both become diseases, forming a syndrome of mixed reality. As far as this disease is concerned, the main clinical practice is to invigorate the kidney and resolve phlegm. On the basis of in-depth research on the pathogenesis, the present invention proposes to treat from the liver, invigorating the liver and nourishing the marrow, supplemented by promoting blood circulation and removing blood stasis, removing phlegm and opening orifices, and improving intelligence. Brain-enhancing and other prescriptions, many years of clinical observation effect is remarkable.

Based on the knowledge of the basic pathogenesis of Alzheimer's disease, on the one hand, the embodiments of the present invention provide 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 according to the embodiment of the present invention contains 1-12 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 , Ginkgo biloba 30-240 parts, Polygala 10-200 parts, Galangal 10-120 parts.

In another embodiment, the traditional Chinese medicine composition for preventing and treating Alzheimer's disease according to the embodiment of the present invention contains 1-12 parts by weight of phosphatidylserine, and also contains the following traditional Chinese medicine components by weight: 10-180 parts of ginseng and the following Chinese medicinal materials extracted Extracts: 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 another embodiment, the traditional Chinese medicine composition for preventing and treating Alzheimer's disease according to the embodiment of the present invention contains 1-12 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 radix and 10-120 parts of galangal extracts.

Therefore, the traditional Chinese medicine composition for preventing and treating Alzheimer's disease uses gastrodia elata as the monarch medicine, ginseng and ginkgo biloba as ministerial medicines, Polygalaceae and galangal as adjuvant medicines, and cooperates with phosphatidylserine, which has a good preventive effect on Alzheimer's disease.

Among them, Gastrodia elata, the king drug, is sweet and flat, and enters the liver meridian. It has the functions of relieving wind and calming convulsions, anti-rheumatic, anti-epileptic, anti-convulsant, sedative and antispasmodic. Its main active ingredients are gastrodin, vanillyl alcohol, vanillin aldehyde, p-hydroxybenzaldehyde and p-hydroxybenzyl alcohol. Studies have shown that Gastrodia elata has the effect of dilating blood vessels, enhancing the elasticity of blood vessels, and improving the blood supply of the basilar artery; it can prevent and treat the elderly by repairing brain cell damage, protecting cerebral blood vessels, improving synaptic plastic damage in the hippocampus, and inhibiting the apoptosis of hippocampal neurons. Dementia; increase cerebral blood perfusion, reduce cerebral ischemia-reperfusion injury, regulate the level of neurotransmitters, regulate the expression levels of some aging-related genes and attenuate apoptosis pathways, and play a role in brain protection; gastrodin and gastrodia elata polysaccharide, promote Cellular immunity and humoral immunity, fully exert antioxidant effect, effectively remove lipid peroxides in serum, brain and other tissues, and improve the activity of various antioxidant enzymes. With the continuous deepening of its research, it has been found in recent years that gastrodin can enter the brain through the blood-brain barrier, and is rapidly decomposed into gastroglycone in the brain, blood and liver, and remains in the tissue in the form of gastroglycone. It has the functions of scavenging free radicals, anti-oxidation, and inhibiting apoptosis of central nervous cells, and has certain curative effects on AD.

Ginseng, sweet, slightly bitter, neutral in nature, returns to the lung, spleen, and heart meridians. "Shen Nong's Materia Medica" lists ginseng as the top grade, saying that it "mainly nourishes the five internal organs, soothes the spirit, calms the soul, stops frights, improves eyesight, improves wisdom, and has the effect of lightening the body and prolonging life when taken for a long time." Modern research has further expanded ginseng. The efficacy of ginseng, as a representative of tonic medicine, a large number of experimental and clinical studies have found that it has the effect of preventing and treating senile dementia. Many doctors believe that ginseng and its compound preparations can prevent and treat Alzheimer's disease, mainly through the methods of nourishing qi and nourishing blood, invigorating kidney and filling essence, etc., which can significantly improve the memory, orientation and understanding of Alzheimer's patients. 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 enhancing the development of brain nerve cells.

Ginkgo biloba is sweet, bitter, astringent, flat, and returns to the heart and lung meridians. Its main component, ginkgo flavonoids, has the functions of dilating coronary arteries, improving coronary blood flow, relieving angina pectoris, lowering blood lipids, resisting lipid oxidation, promoting cerebral blood flow and improving cerebral metabolism. In modern times, it is 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. In the late 1980s, Germany, France and other countries successively developed various preparations of ginkgo biloba extract, and used modern pharmacological methods to study their pharmacological effects, and found a variety of active substances, such as: ginkgo flavonoids, ginkgolides and ginkgo. esters, etc. Among them, ginkgo flavonoids can dilate cerebrovascular, reduce cerebrovascular resistance, reduce capillary permeability, increase cerebral vascular 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 significantly improves the symptoms of Alzheimer's disease, delays the aging process, scavenges free radicals, inhibits the cytotoxicity of β-amyloid, improves nerve cell degeneration, and treats Alzheimer's, cognitive impairment, memory impairment, and language impairment. , disorientation, affective disorders 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 conduction 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 the blood supply to the brain. As people age, phosphatidylserine and other important chemicals in the brain gradually decrease, resulting in reduced memory and cognition. An appropriate amount 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 the raw materials approved by the Ministry of Health to be used as health food. Phosphatidylserine is a new resource food approved by the Ministry of Health in 2010. From the perspective of traditional Chinese medicine conditioning and western medicine nutrition, the composition has multi-level, multi-link and multi-path conditioning for treating Alzheimer's disease, has clear effects, is effective, safe and has no toxic and side effects.

As a preferred embodiment, the above-mentioned traditional Chinese medicine composition for preventing and treating Alzheimer's disease contains 30-90 parts of ginseng, 30-100 parts of Gastrodia elata, 60-120 parts of Ginkgo biloba, 30-100 parts of Polygala Radix, and 30-100 parts of Galangal 60 parts, 2-8 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.

The above-mentioned prescription optimizes the compatibility content of each medicinal material component, so that each component plays the role of monarch, minister and assistant, further the compatibility of the prescription is balanced, so that the traditional Chinese medicine composition for preventing and treating Alzheimer's disease according to the embodiment of the present invention has the functions of nourishing the liver, nourishing the marrow, dredging the collaterals. The functions of phlegm, invigorating intelligence and invigorating brain can significantly improve memory and mild cognitive impairment in clinical practice, thereby improving the efficacy of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease according to the embodiment of the present invention. In addition, each medicinal material is a Chinese medicinal material with the same origin as medicine and food, which is safe and non-toxic, and 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 traditional Chinese medicinal materials in the prescription with a pharmaceutically acceptable solvent. In a preferred embodiment, the extraction treatment is an extraction treatment under the condition of boiling or hot boiling the solvent, of course, other acceptable extraction methods can also be used. In a specific embodiment, the extraction treatment time is 0.5-2.0 h under the condition of solvent boiling or hot boiling. In another specific embodiment, the weight ratio of the total weight of the Chinese medicinal material 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 medicinal components and contents 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 medicinal effect.

On the other hand, on the basis of the above embodiments of the present invention, the embodiments of the present invention provide the following preparation methods for 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 embodiments of the present invention, the ginseng, phosphatidylserine and the traditional Chinese medicine components contained in the traditional Chinese medicine composition for preventing and treating Alzheimer's disease are weighed and each component of the traditional Chinese medicinal materials is weighed;

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 contents of each component are as described above, and in order to save space, they will not be repeated here.

The pulverizing treatment in the above step S02 can be pulverized according to conventional methods in the field of traditional Chinese medicine, such as pulverizing treatment 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 embodiments of the present invention, the ginseng, phosphatidylserine and the traditional Chinese medicine components contained in the traditional Chinese medicine composition for preventing and treating Alzheimer's disease are weighed to weigh each component of the traditional Chinese medicinal materials;

Step S04: the weighed Chinese medicinal materials of Gastrodia elata, Ginkgo biloba, Polygala Radix, and Galangal are soaked in a pharmaceutically acceptable solvent, and then subjected to extraction treatment, and the extract is collected; the extract is concentrated and dried with phosphatidylserine. It is mixed with the crushed ginseng.

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

In the above-mentioned steps S04, the Chinese medicinal materials of Gastrodia elata, Ginkgo biloba, Polygala Radix, and Galangal are soaked in a pharmaceutically acceptable solvent to infiltrate the traditional Chinese medicine raw materials so as to steam out the active functional components therein, and shorten the time of the distillation treatment, thereby improving the efficiency. . Distillation treatment is carried out directly after soaking treatment.

In one embodiment, in this step S04, in the step of soaking the weighed Chinese medicinal materials of Gastrodia elata, Ginkgo biloba, Polygala Radix, and Galangal in a pharmaceutically acceptable solvent, the Chinese medicinal materials of Gastrodia elata, Ginkgo biloba, Polygala Radix, and Galangal The weight ratio of the total weight of the material to the solvent is 1:(6-15); or in a further embodiment, the soaking treatment time is 0-1.0h. By controlling the dosage of ingredients and solvent and soaking time, the extraction amount and extraction rate can be improved. In a specific embodiment, the soaking treatment is a soaking 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 to perform the extraction process. In a further embodiment, the time of solvent boiling extraction treatment is controlled to be 0.5-2.0h. Here, the extraction process may be performed at least once.

Therefore, in a specific embodiment, in this step S04, the Chinese medicinal materials of Gastrodia elata, Ginkgo biloba, Polygala Radix, and Galangal are soaked in a pharmaceutically acceptable solvent and subjected to extraction treatment. Ginger Chinese medicinal materials are added to the solvent, soaked in a closed environment, heated and boiled for extraction for 0.5-2.0 h, and filtered; the filter residue is added to the solvent for secondary extraction by heating and boiling for 0.5-2.0 h. Wherein, the weight ratio of the total weight of the Chinese medicinal materials of Gastrodia elata, Ginkgo biloba, Polygala, Galangal and the solvent is but not only 1:(6-15); the time of the soaking treatment is but not only 0- 1.0h; The filter residue is added in the solvent, but not only with the ratio of the total weight of the Chinese medicinal materials of Gastrodia elata, Ginkgo biloba, Polygala, Galangal and the solvent to be 1:(5-10) by the filter residue. added to the vehicle.

In 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 components of the drug efficacy, but also make the extracted extract safe and low in cost.

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

In this step S04, the above-mentioned drying treatment may be a conventional drying method in the art on the premise that the extracted active ingredients are not destroyed or volatilized. 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 this step S04, the ginseng to be pulverized is passed through a 60-200 mesh sieve.

The mixing treatment in this step S04 is to make each component mix uniformly, therefore, the mixing treatment can be a conventional mixing treatment method in the field that can achieve this purpose.

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 S05: according to the above-mentioned embodiments of the present invention, the ginseng, phosphatidylserine and the traditional Chinese medicine components contained in the traditional Chinese medicine composition for preventing and treating Alzheimer's disease are weighed to weigh each component of the traditional Chinese medicinal materials;

Step S06: the weighed Chinese medicinal materials are soaked in a pharmaceutically acceptable solvent and then extracted, and the extract is collected; the extract is concentrated and dried, and then mixed with phosphatidylserine.

The above-mentioned step S05 is the same as that described in the above-mentioned step S01, and is not repeated here in order to save space.

The soaking treatment, extraction treatment, extraction liquid concentration treatment and drying treatment in the above step S06 are all the same as the soaking treatment, extraction treatment and extraction liquid 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 according to 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 Alzheimer's disease prevention and treatment. The traditional Chinese medicine composition for Haimer's disease has stable efficacy, safety, non-toxicity and controllable quality. Low cost and good feasibility of industrialization.

In another aspect, the embodiments of the present invention further provide a medicine or health food for preventing and treating Alzheimer's disease on the basis of the above-mentioned traditional Chinese medicine composition for preventing and treating Alzheimer's disease and a preparation method thereof. In one embodiment, the medicine 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.

Wherein, the effective dose of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease refers to a therapeutically effective dose, which refers to an amount of the compound of the present invention sufficient to show benefit or clinical significance to an individual. It will be understood by those skilled in the art that the actual amount or dose administered and the schedule of administration will depend upon 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 adjuvant contained in the medicine for preventing and treating Alzheimer's disease or the health food according to the embodiment of the present invention refers to any adjuvant known to those skilled in the art that is suitable for a specific mode of administration. For example, in a specific embodiment, the pharmaceutically acceptable excipients 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 Chinese medicinal compositions for prevention and treatment of Alzheimer's disease.

It should be understood that each of the above-mentioned excipients should be non-toxic, not interfere with or not damage 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 selection of the excipient can be flexibly selected according to the existing dosage forms of the medicine or health food for preventing and treating Alzheimer's disease in the above embodiment.

In addition, the above-mentioned drugs or health food 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 medicine or health food for preventing and treating Alzheimer's disease in the above-mentioned embodiment of the present invention, pharmaceutically acceptable adjuvants and an effective dose of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease can be flexibly selected. Different dosage forms, such as mixtures, oral liquids, capsules, tablets, pills, powders, powders or granules.

Therefore, the medicine or health care product for preventing and treating Alzheimer's disease in the embodiment of the present invention contains an effective dose of the above-mentioned traditional Chinese medicine composition for preventing and treating Alzheimer's disease. The drug or health care product has obvious efficacy in preventing and treating Alzheimer's disease, has no toxic and side effects when taken for a long time, 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 the preparation method thereof.

Example 1

This embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer's disease and a preparation method thereof. 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 the present embodiment:

S11: take gastrodia elata, ginseng, ginkgo biloba, polygala, galangal, and phosphatidylserine according to the measurement ratio;

S12: Ginseng is separately crushed and passed through a 60-mesh sieve, and the ginseng powder is ready for use; the other traditional Chinese medicines are mixed, and water is added for extraction twice, the first time is 12 times the amount of water, boiled and extracted for 1.5 hours, the second time is added with 8 times the amount of water, boiled and extracted for 1 hour , combine the 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 to 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 a preparation method thereof. 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 japonica, 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 the present embodiment:

S21: take gastrodia elata, ginseng, ginkgo biloba, polygala, galangal and phosphatidylserine according to the measurement ratio;

S22: The Chinese medicinal materials are mixed and extracted with 70% ethanol under reflux, the first time adding 12 times the amount of 70% ethanol for 1.5 hours, the second time adding 8 times the amount of 70% ethanol for 1 hour, and combining the two extracts;

S23: Concentrate the extract under reduced pressure, dry under reduced pressure, and pulverize the dry extract; add phosphatidylserine.

Example 3

This embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer's disease and a preparation method thereof. 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 Polygalaceae, 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 the present embodiment:

S31: take gastrodia elata, ginseng, ginkgo biloba, polygala, galangal, and phosphatidylserine according to the measurement ratio;

S31: Ginseng is separately crushed through a 200-mesh sieve, and the ginseng powder is ready for use; mix the remaining Chinese herbal medicines, add water to extract twice, add 15 times the amount of water for the first time, boil and extract for 2.0 hours, add 10 times the amount of water for the second time, and boil and extract For 1.5 hours, the two extracts were combined;

S33: Concentrating the extract, drying under reduced pressure, pulverizing the dry extract, adding 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 a preparation method thereof. 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 the present embodiment:

S41: take gastrodia elata, ginseng, ginkgo biloba, polygala, galangal, and phosphatidylserine according to the measurement ratio;

S42: Ginseng is separately crushed and passed through an 80-mesh sieve, and the ginseng powder is ready for use; the other Chinese medicinal materials are mixed, and water is added to extract twice, the first time is to add 10 times the amount of water, boil for 1.5 hours, and for the second time, add 8 times the amount of water, and boil to extract 1.0 hours, combine the two extracts;

S43: the extract is concentrated and spray-dried; the spray-dried powder is added with phosphatidylserine and ginseng powder for mixing treatment.

Example 5

This embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer's disease and a preparation method thereof. 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 the present embodiment:

S51: take gastrodia elata, ginseng, ginkgo biloba, polygala, galangal, and phosphatidylserine according to the measurement ratio;

S51: Chinese herbal medicines are mixed and extracted twice with water, the first time adding 12 times the amount of water, boiling and extracting for 2.0 hours, the second time adding 8 times the amount of water, boiling and extracting for 1.0 hours, and combining the two extracts;

S53: the extract is concentrated and spray-dried; phosphatidylserine is added and mixed.

Example 6

This embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer's disease and a preparation method thereof. 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 the present embodiment:

S61: take gastrodia elata, ginseng, ginkgo biloba, polygala, galangal, and phosphatidylserine according to the measurement ratio;

S62: The traditional Chinese medicinal materials are crushed and passed through an 80-mesh sieve; phosphatidylserine is added and mixed to obtain a finished powder.

Example 7

This embodiment provides a traditional Chinese medicine composition for preventing and treating Alzheimer's disease and a preparation method thereof. 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 Geriatrics.

2. The purpose of the experiment

Research the function of the composition of the present invention to prevent and treat Alzheimer's disease and improve memory.

3. Experimental materials

Sample 1 was provided by Shenzhen Institute of Geriatrics (prepared the Chinese medicine composition obtained in Example 4, and prepared into tablets by adding auxiliary materials), the appearance is brown tablets, and the recommended oral dose for human body is 0.8g/tablet, 3 tablets each time, each time 3 times a day, based on the body weight of 60kg per person, the equivalent dose is 0.12g/kg.bw.

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

Phosphatidylserine is provided by Shaanxi AOC Biotechnology Co., Ltd. The recommended oral dose for human body is 600mg/day, calculated based on the body weight of 60kg, the equivalent dose is 10mg/kg.bw.

Huperzine A tablets were provided by Xiansheng Pharmaceutical Co., Ltd., 0.05mg/tablet, 4 tablets at a time, 2 times a day, calculated based on the body weight of 60kg per person, the equivalent dose was 0.007mg/kg.bw.

4. Experimental method

4.1 Dose Settings

The dose settings of each sample are shown in Table 1. The samples of each dose group were dissolved, diluted and adjusted 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

Animals were reared adaptively for 3 days, and then the experimental group observation was started. 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 traditional Chinese medicine composition group. , phosphatidylserine group and huperzine A group, 10 animals in each group, were given corresponding preparations by gavage according to the grouping situation, once a day, for 7 days.

4.2.1.1 Preparation and test of memory acquisition disorder model Scopolamine (3mg/kg, ip) was used to prepare memory acquisition disorder model. The experimental animals were continuously given the corresponding test substances for 30 days according to the grouping situation. After 30 minutes of the test substances on the 30th day, the model control group, the sample 1 high, medium and low dose groups, the traditional Chinese medicine composition group, the phosphatidylserine group, the huperzine A group. All groups were intraperitoneally injected with scopolamine (3 mg/kg), and the platform training was started 10 minutes later. On the 31st day, after giving the test substance for 30 minutes, the memory performance was tested by the platform jumping 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 substances for 30 days according to the grouping situation, and after 30 minutes of the test drugs on the 30th day, they were trained in the dark avoidance method. On the 31st day, after the test substance was administered for 30 minutes, 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 were all treated with 40% ethanol 0.1mL/10g body weight. After gavage, the memory score was tested 30 minutes later.

4.2.1.3 Platform jumping test Put the mice in the platform jumping apparatus, and after 5 minutes of adaptation to the environment, put them on the platform lightly. When the animal jumps off the platform and touches the copper grid, it is given 40V AC voltage stimulation. The normal response of mice is to jump back to the platform to avoid the noxious stimulus. The animal may jump off the platform one or more times, and then jump back to the platform after receiving the shock. The number of times the mice jumped off the platform and touched the copper grid with their feet was recorded as the number of errors, and the training was performed for 5 minutes. After 24 hours, a memory score test was performed. Place the mouse on the platform, record its latency (SL) on the safety platform and the number of electric shocks (error times) within 3 min. If the mouse stays on the platform for more than 3 min, its latency is counted as 180s.

4.2.1.4 The mice were trained 30 minutes after the last administration in the dark avoidance test, and the mice were placed in the bright room with their faces facing away from the hole, and the timer was started. Animals entered the dark room through the hole and received electric shocks, and the timing stopped automatically. Take out the mice and record the time it takes for the mice to encounter electric shocks from being placed in the bright room into the dark room, which is the latency period. The test was repeated 24 hours later, and the incubation period of each animal entering the dark room and the number of electric shocks within 5 minutes were recorded (for those who did not enter the dark room within 5 minutes, the incubation period was calculated as 300 s).

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

4.2.2.1 After the observation of drug administration and learning and memory testing, 8 mice were randomly selected from each group in the dark avoidance experiment, and 1% pentobarbitone (40 mg/Kg body weight, intraperitoneal injection) was anesthetized and the left ventricle was opened. The aortic cannula was ligated, rinsed with 50 mL of normal saline, and then perfused with cold paraformaldehyde glutaraldehyde infusion fixative. The brain was taken out and fixed in the perfusion solution for 2 h (4°C), and then added into 20% sucrose buffer (0.1 M, pH7.4) for 24h (4°C), the crown of AO cryostat was serially sliced, the slice thickness was 30 μm, and the slices were collected in 0.1M PBS for use.

4.2.2.2 Incubation slices

4.2.2.2.1 Elias method for RNA histochemical staining: slide the sections down to water; put the dye solution (10 mL of 0.5% methyl green plus 20 mg of Quanronin Y) in a constant temperature incubator at 37 °C for 1 h; wash with distilled water at 0 °C-2 °C for 2 min; Washed with tert-butanol; dehydrated twice with tert-butanol, 3 min/time; sealed with xylene transparent neutral gum (for photos, digested with RNase solution (8 mg RNase dissolved in 10 mL of distilled water) at 37°C for 1 h and then added to the dye solution).

4.2.2.2.2 Nissl body stained sections were degreased in xylene for 2 times, 3 min each time, and descended to water; 1% tar violet staining solution at 37°C for 10 min; 70% ethanol 3 times, 1 min/time; 95% ethanol 3 times, 1 min /time; absolute ethanol 3 times, 1min/time; xylene transparent 2 times, 5min/time; neutral gum sealing.

4.2.2.2.3 Quantitative detection Quantitative analysis used LM ZEISS Axiotron research microscope, JVC KY-F30B3-CCD Variocam cryo-camcorder and Kontron IBAS 2.0 automatic image analyzer. The measurement area of the cerebral cortex selects the third layer of the temporal cortex, that is, the outer pyramidal cell layer, and the hippocampus measures the pyramidal cells in the CA1 area. The corrected OD value (COD) is obtained by subtracting the background OD value from the OD value, that is, the actual optical density of the reaction product. 3 slices are randomly selected for each index of each case, and each slice is randomly measured in 3 fields of view in the measurement area, and all measurements are performed under the same optical conditions. complete below.

4.3 Statistics of test data

The data were expressed as mean ± standard deviation (mean ± SD), and SPSS17.0 software was used for statistics. The comparison between groups was performed by group t test. When P<0.05, it indicated that there was a significant difference between groups.

5. Experimental results

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

5.1.1 The effect of the composition on the latency and the number of errors in the platform jumping test in mice

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

Analysis of interaction properties. The middle-dose group, the traditional Chinese medicine composition group and the phosphatidylserine group of sample 1 were analyzed. The traditional Chinese medicine composition and phosphatidylserine were used in combination, and the effect was better than the two used alone, and there was a synergistic effect between the two. (E _{sample 1 medium dose group} >E _{traditional Chinese medicine composition} +E _{phosphatidylserine} ).

n＝10)The effect of the composition of table 2 on the latency and the number of errors in the platform jumping test in mice (

n=10)

(Memory Acquisition Disorder Model)

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

5.1.2 The effect of the composition on the latency and the number of errors in the dark avoidance test in mice

As can be seen from Table 3, compared with the model group, the dark avoidance latency of the mice in each administration group was prolonged to a certain extent, and the number of errors was reduced. Among them, the latency period of sample 1 high, medium and low dose groups, traditional Chinese medicine composition group, phosphatidylserine group and huperzine A group was significantly different from the model group (P<0.05); Compared with the model group, the number of errors in the dose group, the traditional Chinese medicine composition group and the huperzine A group was significantly different (P<0.05). The results showed that the composition, traditional Chinese medicine composition, phosphatidylserine and huperzine A significantly promoted the memory reproduction process.

Analysis of the interaction properties, the middle dose group, the traditional Chinese medicine composition group and the phosphatidylserine group of sample 1 were analyzed. The traditional Chinese medicine composition and phosphatidylserine were used in combination to prolong the dark avoidance incubation period. There is a synergistic effect (E _{sample 1 medium dose group} >E _{traditional Chinese medicine composition} +E _{phosphatidylserine} ).

n＝10)The effect of the composition of table 3 on the latency and the number of mistakes in the dark avoidance test in mice (

n=10)

(Memory Reproduction Disorder Model)

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

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

From the results in Table 4, it can be seen that the content of RNA and Nissl bodies in normal rat neurons, especially in cortical and hippocampal pyramidal neurons, is very rich, indicating that the related neurons have vigorous metabolism, and the content of RNA and Nissl bodies in the model group is significantly reduced, indicating that their cells There is a metabolic disorder, and each dose group of sample 1 can increase the content of RNA and Nissl body in the temporal lobe cortex and hippocampal pyramidal cells of the model mice to varying degrees, indicating that the composition can significantly improve the nucleic acid metabolism and protein synthesis and metabolism of senile dementia mice. In this way, it can improve and regulate the metabolism of the entire neuron, and play a role in the prevention and treatment of Alzheimer's disease.

Table 4. Effects of composition on the content of RNA and Nissl body in vertebral cells in the extracortex of temporal lobe and hippocampal CA1 area of model mice ( n=8)

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

It can be seen from the above experimental results that the study found that the traditional Chinese medicine composition for preventing and treating Alzheimer's disease provided in 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 cerebral cortex and hippocampal pyramidal cells. It can improve brain nucleic acid metabolism and protein synthesis and metabolism, promote and regulate RNA metabolism in cerebral cortex and hippocampus, improve and regulate the metabolism of entire neurons and the key brain of learning and memory. The neuronal structure of the area 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 shall be included in the protection of the present invention. within the range.

Claims (7)

1. a Chinese medicine composition for the prevention and treatment of Alzheimer's disease is characterized in that being made up of the following components: the Chinese medicine components of 6 parts by weight of phosphatidylserine and the following parts by weight: or 20 parts of ginseng and the following herbal extracts: 60 parts of Gastrodia elata extract, 60 parts of Ginkgo biloba extract, 40 parts of Polygalaceae 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 Polygalaceae and 30 parts of galangal extracts; Wherein, the gastrodia elata is a monarch medicine, the ginseng and the ginkgo biloba are ministerial medicines, the polygala and the galangal are adjuvant medicines, and the phosphatidylserine is a combination medicine; The preparation method of the traditional Chinese medicine composition for preventing and treating Alzheimer's disease comprises the following steps: According to the phosphatidylserine contained in the traditional Chinese medicine composition for preventing and treating Alzheimer's disease and the traditional Chinese medicine components, each component Chinese medicinal material is weighed; The weighed Chinese medicinal materials of Gastrodia elata, Ginkgo biloba, Polygala Radix, and Galangal are soaked in a pharmaceutically acceptable solvent, and then subjected to extraction treatment, and the extract is collected; The ginseng is mixed; The solvent is water or an aqueous ethanol solution. 2 . The traditional Chinese medicine composition according to claim 1 , wherein the extraction treatment is to boil the mixture after the solvent extraction treatment for 0.5-2.0 h. 3 . 3. Chinese medicine composition according to claim 1, is characterized in that: in described soaking process, the total weight of described Chinese medicinal material and the weight ratio of described solvent are 1:(6-15); And/ or The soaking treatment time is greater than 0h and less than or equal to 1h. 4. The traditional Chinese medicine composition according to claim 1, wherein the step of extracting is repeated at least once. 5. Chinese medicine composition according to claim 1, is characterized in that: 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; After being crushed, pass through a 60-200 mesh sieve. 6. A medicine or health product for preventing and treating Alzheimer's disease, characterized in that: the traditional Chinese medicine composition described in any one of claims 1-5 comprising a pharmaceutically acceptable adjuvant and an effective dose. 7. The medicine or health product according to claim 6, wherein the dosage form is any dosage form in a mixture, a capsule, a tablet, a pill, a powder or a granule.