A Chinese medicine composition for treating Alzheimer's dementia and preparation method thereof

By using a traditional Chinese medicine composition made of a variety of traditional Chinese medicine ingredients, the active ingredients are extracted through water extraction and alcohol extraction and thick paste, the problems of poor efficacy and great side effects in the treatment of Alzheimer's disease dementia are solved, and the effect of effectively improving patients' cognitive function and memory is achieved.

CN118987137BActive Publication Date: 2025-04-18THE FIRST HOSPITAL OF HUNAN UNIV OF CHINESE MEDICINE (CLINICAL RES INST OF TRADITIONAL CHINESE MEDICINE)
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Patent Information

Application Number
CN202411033168.2
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-07-30
Publication Date
2025-04-18
Estimated Expiration
2044-07-30

AI Technical Summary

Technical Problem

The prior art is ineffective in treating Alzheimer's disease dementia, and has problems such as side effects, high cost and inconvenience in use.

Method used

It adopts a traditional Chinese medicine composition, which is made of ingredients such as Yuanzhi, Astragalus, Cuscuta, Schisandra granulum, Dragon Bone, Chuanxiong, Blood Fever, Mahogany, Arizona, Rhodiola, American ginseng, licorice, Poria, Angelica sinensis, Ganoderma lucidum, Yam, Cypress, Salvia miltiorrhiza, Polygonatum, Polygonatum, Oyster, Longan meat and Pureen kernel. The active ingredients are extracted through water extraction and alcohol extraction, and then mixed, boiled at 60°C and concentrated under reduced pressure to form a thick paste.

Benefits of technology

This traditional Chinese medicine composition can effectively improve the cognitive function and memory of patients with Alzheimer's disease dementia, reduce side effects, is cheap, is easy to use, and its efficacy has been confirmed through long-term clinical verification.

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Abstract

The invention discloses a Chinese medicine composition for treating Alzheimer's dementia and a preparation method thereof. The Chinese medicine composition is prepared from the following raw materials in parts by weight: 90-100 parts of Polygala tenuifolia, 50-55 parts of Astragalus membranaceus, 50-55 parts of Cuscuta chinensis, 75-80 parts of Schisandra chinensis, 75-80 parts of Acorus calamus, 50-55 parts of Dragon's bone, 75-80 parts of Chuanxiong, 10-20 parts of Sanguisorba officinalis, 40-50 parts of Terminalia chebula, and Rhizoma Anemarrhenae. 75-80 parts, 60-70 parts of rhodiola rosea, 75-80 parts of American ginseng, 25-30 parts of liquorice, 50-55 parts of poria, 60-70 parts of angelica, 40-45 parts of ganoderma lucidum, 75-80 parts of yam, 25-30 parts of cypress seed, 75-80 parts of salvia miltiorrhiza, 60-70 parts of American ginseng, 75-80 parts of polygonatum, 75-80 parts of oyster, 50-60 parts of longan pulp and 75-80 parts of oxyphylla. The raw materials are respectively subjected to water extraction, alcohol extraction and grinding treatment according to the effective components, and then boiled to exert the medicinal properties, invigorate qi and replenish blood, promote brain blood circulation, and have a significant effect in treating Alzheimer's dementia.
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Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine health products, and in particular to a traditional Chinese medicine composition for treating Alzheimer's dementia and a preparation method thereof. Background Art

[0002] Alzheimer's dementia is a chronic disease. Common types include Alzheimer's disease and vascular dementia. The course of the disease often lasts for many years. Most patients cannot take care of themselves, which places a huge burden on their families and society. At present, there are 130 million elderly people in my country, of which about 5 million to 6 million are over 65 years old and suffer from Alzheimer's dementia. By the middle of the 21st century, the number of elderly people in my country will increase to about 400 million, and by then there will be about 16 million to 20 million patients with Alzheimer's dementia. The problem of Alzheimer's dementia is also an inevitable trend with the development of an aging population.

[0003] The current Western medicine treatment for Alzheimer's dementia mainly focuses on preventing stroke, improving cognitive function, and controlling behavioral and psychiatric symptoms. Cholinesterase inhibitors, cerebral circulation improvers, peptide nootropics, free radical scavengers, and antioxidants are often used in clinical practice, and their effectiveness still needs further study. The treatment of patients with dementia and disability due to brain damage mainly focuses on lowering blood lipids and blood pressure, dilating blood vessels, improving circulation, promoting metabolism, and inducing neurogenic factors, but the overall efficacy is poor and there are obvious limitations in the treatment methods.

[0004] Traditional Chinese medicine believes that the cause of this disease is mainly internal, mostly due to old age, physical weakness, emotional injury, long-term illness and other reasons that lead to insufficient qi and blood, kidney essence loss, brain marrow malnutrition, or qi stagnation, phlegm obstruction, and blood stasis in the brain. The main location of dementia is in the brain, which is closely related to dysfunction of the heart, liver, spleen and kidney. In terms of treatment, it is necessary to activate qi and replenish blood, replenish qi and nourish blood, and awaken the brain and open the mind, and the disease will gradually improve.

[0005] Therefore, those skilled in the art are committed to developing a Chinese medicine composition and preparation method for treating Alzheimer's dementia with definite efficacy, safety, convenience, low side effects and low price. Summary of the invention

[0006] In view of the above-mentioned defects of the prior art, the technical problem to be solved by the present invention is to provide a Chinese medicine composition with definite efficacy, safety, convenience, low side effects and low price for treating Alzheimer's dementia.

[0007] To achieve the above object, the present invention provides a Chinese medicine composition for treating Alzheimer's dementia, which is prepared from the following raw materials in parts by weight: 90-100 parts of Polygala tenuifolia, 50-55 parts of Astragalus membranaceus, 50-55 parts of Cuscuta australis, 75-80 parts of Schisandra chinensis, 75-80 parts of Acorus calamus, 50-55 parts of Dragon Bone, 75-80 parts of Chuanxiong, 10-20 parts of Sanguisorba officinalis, 40-50 parts of Terminalia chebula, 75-80 parts of Anemarrhena asphodeloides. ~80 parts, Rhodiola rosea 60-70 parts, American ginseng 75-80 parts, Licorice root 25-30 parts, Poria cocos 50-55 parts, Angelica sinensis 60-70 parts, Ganoderma lucidum 40-45 parts, Dioscorea opposita 75-80 parts, Platycladus orientalis 25-30 parts, Salvia miltiorrhiza 75-80 parts, American ginseng 60-70 parts, Polygonatum sibiricum 75-80 parts, Oyster 75-80 parts, Longan pulp 50-60 parts and Alpinia oxyphylla 75-80 parts.

[0008] The invention is prepared from the following raw materials in parts by weight: 90 parts of Polygala tenuifolia, 50 parts of Astragalus membranaceus, 50 parts of Cuscuta chinensis, 75 parts of Schisandra chinensis, 75 parts of Acorus calamus, 50 parts of Dragon Bone, 75 parts of Ligusticum chuanxiong, 10 parts of Sanguisorba officinalis, 40 parts of Terminalia chebula, 75 parts of Anemarrhena asphodeloides, 60 parts of Rhodiola rosea, 75 parts of American ginseng, 25 parts of Licorice, 50 parts of Poria cocos, 60 parts of Angelica sinensis, 40 parts of Ganoderma lucidum, 75 parts of Dioscorea opposita, 25 parts of Platycladus orientalis seeds, 75 parts of Salvia miltiorrhiza, 60 parts of American ginseng, 75 parts of Polygonatum sibiricum, 75 parts of Oyster, 50 parts of Longan pulp and 75 parts of Alpinia oxyphylla seeds.

[0009] The invention is prepared from the following raw materials in parts by weight: 100 parts of Polygala tenuifolia, 55 parts of Astragalus membranaceus, 55 parts of Cuscuta chinensis, 80 parts of Schisandra chinensis, 80 parts of Acorus calamus, 55 parts of Dragon Bone, 80 parts of Ligusticum chuanxiong, 20 parts of Sanguisorba officinalis, 50 parts of Terminalia chebula, 80 parts of Anemarrhena asphodeloides, 70 parts of Rhodiola rosea, 80 parts of American ginseng, 30 parts of Licorice, 55 parts of Poria cocos, 70 parts of Angelica sinensis, 45 parts of Ganoderma lucidum, 80 parts of Dioscorea opposita, 30 parts of Platycladus orientalis, 80 parts of Salvia miltiorrhiza, 70 parts of American ginseng, 80 parts of Polygonatum sibiricum, 80 parts of Oyster, 60 parts of Longan pulp and 80 parts of Alpinia oxyphylla.

[0010] The invention is prepared from the following raw materials in parts by weight: 95 parts of Polygala tenuifolia, 55 parts of Astragalus membranaceus, 52 parts of Cuscuta chinensis, 78 parts of Schisandra chinensis, 76 parts of Acorus calamus, 50 parts of Dragon Bone, 80 parts of Ligusticum chuanxiong, 20 parts of Sanguisorba officinalis, 45 parts of Terminalia chebula, 80 parts of Anemarrhena asphodeloides, 60 parts of Rhodiola rosea, 75 parts of American ginseng, 30 parts of Licorice, 50 parts of Poria cocos, 60 parts of Angelica sinensis, 40 parts of Ganoderma lucidum, 80 parts of Dioscorea opposita, 30 parts of Platycladus orientalis seeds, 80 parts of Salvia miltiorrhiza, 70 parts of American ginseng, 80 parts of Polygonatum sibiricum, 75 parts of Oyster, 60 parts of Longan pulp and 80 parts of Alpinia oxyphylla seeds.

[0011] The invention is prepared from the following raw materials in parts by weight: 100 parts of Polygala tenuifolia, 50 parts of Astragalus membranaceus, 50 parts of Cuscuta chinensis, 80 parts of Schisandra chinensis, 75 parts of Acorus calamus, 50 parts of Dragon's bone, 76 parts of Ligusticum chuanxiong, 15 parts of Sanguisorba officinalis, 45 parts of Terminalia chebula, 80 parts of Anemarrhena asphodeloides, 60 parts of Rhodiola rosea, 80 parts of American ginseng, 25 parts of Licorice, 50 parts of Poria cocos, 65 parts of Angelica sinensis, 45 parts of Ganoderma lucidum, 80 parts of Dioscorea opposita, 25 parts of Platycladus orientalis seeds, 75 parts of Salvia miltiorrhiza, 65 parts of American ginseng, 80 parts of Polygonatum sibiricum, 80 parts of Oyster, 50 parts of Longan pulp and 80 parts of Alpinia oxyphylla seeds.

[0012] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition for treating Alzheimer's dementia, comprising the following steps:

[0013] S1. Wash and dry the above Chinese medicinal materials separately and weigh them according to the weight;

[0014] S2. extracting the effective components of the following Chinese medicinal materials by water extraction: Polygala, Astragalus, Anemarrhena, Rhodiola, American ginseng, Licorice, Poria, Angelica, Dioscorea and Polygonatum, mixing and extracting the filtrate to obtain a water extraction filtrate;

[0015] The effective components of the following Chinese medicinal materials are extracted by alcohol extraction: Cuscuta chinensis, Schisandra chinensis, Acorus calamus, Ligusticum chuanxiong, Sanguisorba officinalis, Terminalia chebula, Ganoderma lucidum, Platycladus orientalis, Salvia miltiorrhiza, American ginseng, Longan pulp and Alpinia oxyphylla, and the mixture is mixed to obtain the alcohol extraction filtrate;

[0016] Grind the dragon bones and oysters separately and sieve them into 100-mesh powder;

[0017] S3. The water extraction filtrate, the alcohol extraction filtrate and the powder are mixed and added into a pot and boiled at 60° C. for 30 minutes, and then concentrated under reduced pressure to a thick paste with a relative density of 1.1 to 1.2.

[0018] Furthermore, in step S2, the step of obtaining the water extraction filtrate is: adding 10 times the amount of water, boiling and then simmering for 1 hour, filtering the filtrate, repeating the decocting of the residue twice, and combining the filtrate.

[0019] Furthermore, in step S2, the step of obtaining the alcohol extraction filtrate is: adding 95% ethanol, according to the volume ratio of medicinal materials to ethanol of 1:8, reflux extraction at 60°C for 2 hours, filtering the filtrate, repeating the extraction of the medicinal residue once, and combining the filtrate.

[0020] Furthermore, the thick paste can be further prepared into powder, decoction, granules, tablets or capsules.

[0021] Furthermore, the thick paste can be further prepared into powder, and the preparation method thereof is to place the thick paste under vacuum drying at 50° C. to obtain dry powder.

[0022] The above composition is based on weight ratio, which can be increased or decreased in proportion during production. For example, large-scale production can be measured in kilograms or tons, and small-scale production can be measured in grams. The weight can be increased or decreased, but the weight ratio of the raw medicinal materials in each composition remains unchanged.

[0023] The beneficial effects of the invention are as follows: the invention is a special formula carefully matched according to the prescription principle of "monarch, minister, assistant and envoy" in the theory of Chinese medicine paste prescriptions, with Polygala, Acorus calamus, Cuscuta australis, Astragalus, Schisandra chinensis, Angelica sinensis and Chuanxiong as the monarch prescription, mainly for invigorating qi and replenishing qi; Terminalia chebula, Rhodiola rosea, Sanguisorba officinalis and American ginseng as the assistant prescriptions, mainly for replenishing blood, improving blood supply and oxygen supply to the brain and promoting blood circulation in the brain; Dragon bone, Polygala, Acorus calamus and Ganoderma lucidum as the assistant prescriptions have the effects of replenishing heart and kidney, improving intelligence and tranquilizing the mind, and are used for insomnia, forgetfulness, mental fatigue and physical fatigue caused by disharmony between the heart and kidney, so as to enhance the effect of the monarch prescription on treating forgetfulness; Chuanxiong, Anemarrhena asphodeloides, Poria, Licorice, Longan pulp and Oyster are used as the assistant prescriptions, firstly, to enhance the effect of the monarch prescription on treating forgetfulness; secondly, the medicine has the effects of nourishing blood, calming the mind and tranquilizing the mind, clearing away heat and relieving restlessness, and is suitable for insomnia caused by liver blood deficiency and excessive pressure. It is supplemented with Alpinia oxyphyllae, which warms the kidneys, improves intelligence, and awakens the brain; it is supplemented with Platycodon grandiflorum and Ginseng to soothe the mind and help memory; it is supplemented with Chinese yam and Polygonatum sibiricum to nourish the kidneys, nourish yin and strengthen the brain; it is supplemented with Salvia miltiorrhiza to promote blood circulation and clear the meridians, relieve depression and soothe the mind; the guiding drug is licorice, which harmonizes the various drugs and corrects the taste; so that the whole formula is nourishing and clearing, nourishing without stagnation. After long-term clinical verification, its efficacy has been clinically verified. DETAILED DESCRIPTION

[0024] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0025] All features disclosed in this specification, or steps in all methods or processes disclosed, except mutually exclusive features and / or steps, may be combined in any manner and, unless otherwise stated, may be replaced by other equivalent or alternative features having similar purposes, that is, unless otherwise stated, each feature is merely one embodiment of a series of equivalent or similar features.

[0026] According to TCM theory, the brain is located in the skull and is formed by the collection of marrow. So how is the marrow produced? "Lingshu·Jingmai" points out: "When a person is born, the essence is formed first, and then the brain marrow is produced after the essence is formed." It is believed that the brain marrow comes from the innate essence of a person, that is, the reproductive essence of the parents, and the kidney is responsible for reproduction. The reproductive essence is actually controlled by the kidney, so the formation and development of the brain marrow are closely related to the function of the kidney. The innate reproductive essence is the basic substance for the formation of the brain marrow, and the acquired essence is the source of nutrition that continuously enriches the brain marrow. The acquired essence is the essence of the five internal organs and six bowels, which is stored by the kidney, just as "Sujian·Shanggu Tianzhen Lun" said: "The kidney governs water, receives the essence of the five internal organs and six bowels and stores it." If the kidney essence is sufficient, the bone marrow will be active, and if the bone marrow is abundant, the brain will be healthy, energetic, strong, and powerful, with sharp ears and eyes, and strong memory; if the kidney essence is deficient, the essence is insufficient, the brain is empty, the skills and practical ability are poor, and forgetfulness, insomnia, mental dullness and aging will follow. Therefore, "Lingshu·Hai Lun" says: "If the marrow sea is sufficient, then the body will be light and strong, and will exceed the limit. If the marrow sea is insufficient, then the brain will be spinning, the ears will be ringing, the legs will be swollen, the eyes will be blind, and the body will be lazy and sleepy." From the above, it is not difficult to understand why Chinese medicine emphasizes nourishing the kidney to improve intelligence. Starting from nourishing the kidney and filling the essence, regenerating marrow to improve the brain, and achieving the purpose of enhancing wisdom, is one of the important principles of Chinese medicine to improve intelligence. The ancients said that if you want to nourish the marrow of the brain, you must first nourish the essence in the kidney, which is what they meant.

[0027] Finally, on this basis, if we add the methods of invigorating qi and replenishing blood, invigorating qi and nourishing blood, and awakening the brain and opening the orifices, we can greatly improve the health of the brain, thereby treating Alzheimer's dementia and restoring brain vitality in the elderly.

[0028] Based on the above theory, the present invention adopts the following raw materials:

[0029] Polygala: bitter, pungent, warm. Enters the heart, kidney, and lung meridians. Polygala is pungent, dispersing, bitter, warm, and enters the heart, lung, and kidney meridians. It not only helps the heart yang and benefits the heart qi, but also makes the kidney qi go up to the heart to calm the mind and improve intelligence. It also removes phlegm and opens the mind, and is good at treating symptoms of restlessness or phlegm blocking the mind. This product contains saponins, polygala ketone, alkaloids, polygala alcohol, polygala linalool, fatty oil, resin and other ingredients. It has the effects of calming the mind and improving intelligence, connecting the heart and kidney, removing phlegm, and reducing swelling.

[0030] Astragalus: sweet in nature, slightly warm, enters the spleen and lung meridians. Astragalus is sweet and warm, nourishing and ascending, sweet and mild, penetrating and promoting; slightly warm when used raw, warm when roasted with honey, enters the spleen and lung meridians, mainly to support the positive energy, and can also remove water evil. It is good at replenishing the middle qi, raising the clear yang, replenishing the lung qi, benefiting the stomach and strengthening the exterior, treating spleen and lung qi deficiency, sinking of the middle qi, qi not being able to hold blood, spontaneous sweating and night sweats, etc. It can also support sores and poisons, promote diuresis and reduce swelling, and treat sores and carbuncles that do not ulcerate or ulcerate for a long time due to insufficient qi and blood, as well as qi deficiency edema and urinary difficulty.

[0031] Cuscuta: Spicy, sweet, neutral, enters the liver, kidney, and spleen meridians. Cuscuta is sweet, nourishing, spicy and moist, neutral and warm in nature, and can nourish yin and yang, and also has astringent properties. It enters the kidney meridian, is good at nourishing yang and yin, consolidating essence and reducing urine, and can treat impotence due to kidney deficiency, spermatorrhea, frequent urination, and leucorrhea; it enters the liver and spleen meridians, is good at nourishing the liver and improving eyesight, nourishing the spleen and stopping diarrhea, and can treat blurred vision and diarrhea due to spleen deficiency. In addition, it can also stabilize the fetus by nourishing the liver and kidneys, and can also produce fluid and quench thirst by regulating yin and yang, and can treat kidney deficiency, restless fetuses, and thirst. It mainly contains flavonoids, organic acids and other ingredients, as well as trace elements and amino acids such as calcium, potassium, and phosphorus.

[0032] Schisandra chinensis: The medicinal properties are sour, sweet, warm, and enter the lung, heart, and kidney meridians. Schisandra chinensis is sour, astringent, moist, warm and nourishing, and has both astringent and nourishing properties. It enters the lung, kidney, and heart meridians. It can astringe the lungs, relieve cough and asthma, nourish the kidneys, astringe the essence, and stop diarrhea. It can produce fluid, calm the mind, and strengthen the exterior to astringe and stop sweating. It has all five flavors, but only the sour one is better; although it is warm in nature, it is moist in nature; it is astringent and nourishing, and it can save energy and provide reinforcement. It has a strong medicinal effect and is an important medicine for tonic, strengthening, and astringing. It also has the effect of improving sleep and brain tissue function.

[0033] Acorus calamus: pungent, bitter, warm. Enters the heart and stomach meridians. Acorus calamus is pungent, fragrant, bitter, dry, warm, and enters the heart and stomach meridians. It is good at transforming phlegm and dampness, opening the orifices, and treating symptoms of phlegm and dampness blocking the heart orifices; it can also calm the mind and harmonize the stomach qi, and treat palpitations, insomnia, forgetfulness, and trance caused by deficiency of heart qi, as well as dampness and turbidity blocking the middle and mute dysentery. It also has the ability to improve spatial cognition and enhance learning and memory.

[0034] Dragon bone: astringent, sweet, neutral. It enters the heart, liver, and kidney meridians. It calms the mind and soothes the nerves, soothes the liver and suppresses yang, consolidates and astringes, and is used for palpitations, insomnia and forgetfulness, epilepsy and madness, dizziness, spontaneous sweating and night sweats, spermatorrhea and enuresis, metrorrhagia and leukorrhea, chronic diarrhea and dysentery, ulcers that do not heal for a long time, and eczema. Dragon bone has a wide range of indications, but it is not separated from its function of restraining floating qi and its astringent nature to remove and consolidate qi. Ghosts in the heart and stomach, old spirits, children's heat and epilepsy, and dreams of ghosts at night are caused by floating and restless minds. Dragon bone can calm the mind and calm the soul.

[0035] Chuanxiong: pungent and warm in nature. Enters the liver, gallbladder, and pericardium meridians. Chuanxiong is pungent and fragrant, dispersing and warming, and enters the liver, gallbladder, and pericardium meridians. It goes up to the head and down to the blood sea, promoting blood and qi inside, and dispersing wind and cold outside. It has a strong blood-activating effect, and treats various pains caused by blood stasis and qi stagnation. It is most suitable for those with cold and combined pain. It was praised by predecessors as "the qi medicine in the blood". It is the best medicine for treating various headaches, and is best for those with wind-cold and blood stasis. It can also be used for those with wind-heat, rheumatism, and blood deficiency. Therefore, predecessors said that "headaches cannot be separated from Chuanxiong". It also has the ability to enhance cell vitality, improve learning and memory ability, and increase the survival rate of dopamine neurons.

[0036] Terminalia chebula: neutral in nature, sweet and astringent in taste. No meridians. Clears away heat and detoxifies, astringes and nourishes blood, and harmonizes various medicines. It is a heat-clearing and detoxifying medicine under the category of heat-clearing medicines. It has antidepressant effects, heart protection and vasodilation effects, and protects the rat brain from oxidative stress.

[0037] Rhizoma Anemarrhenae: bitter, sweet, cold in nature. It enters the lung, stomach, and kidney meridians. Rhizoma Anemarrhenae is bitter, cold, sweet, moist, and smooth. It enters the lung, stomach, kidney, and large intestine meridians. It is not only clearing heat, but also not dispersing. It nourishes yin. It clears lung heat and purges fire, clears stomach heat and eliminates thirst, nourishes kidney yin and moistens the intestines, and relieves deficiency heat. Although it is not as good as gypsum in clearing heat and purging fire, it is good at nourishing yin and moistening dryness, and removing evil and strengthening the body. It is suitable for both real fire and deficiency heat, and is especially suitable for those with high fever or dry heat and body fluid damage and yin deficiency fever. This product contains saponins, Rhizoma Anemarrhenae polysaccharides, mangiferin, isomangiferin, alkaloids, and organic acids. It has the effects of clearing heat and purging fire, nourishing yin and moistening dryness. Rhizoma Anemarrhenae active ingredient Rhizoma Anemarrhenae saponin is a new anti-Alzheimer's dementia drug, which can significantly improve the learning and memory ability of naturally aged rats and the memory ability of the elderly.

[0038] Rhodiola rosea: sweet, bitter, neutral. Enters the lung and heart meridians. Rhodiola rosea is sweet, tonifying, bitter, purging, neutral and slightly cool, tonifying and dispersing, and enters the lung and heart meridians. It can replenish qi, relieve asthma, activate blood circulation and unclog the meridians. It is good at treating qi deficiency, fatigue, chronic cough, asthma, and various symptoms caused by qi deficiency, blood stasis, and blood stasis, especially those with heat. It has the effects of replenishing qi, activating blood circulation, relieving asthma, and a certain intelligence-enhancing effect, improving learning and memory ability.

[0039] American ginseng: sweet and spicy, cool in nature, non-toxic. Enters the heart, lung, and kidney meridians. Benefits lung yin, clears deficient fire, promotes fluid production and quenches thirst. Treats chronic cough due to lung deficiency, blood loss, dry throat and thirst, and fatigue due to deficiency heat. It has the ability to resist fatigue and enhance the ability to tolerate hypoxia, and can also improve memory acquisition.

[0040] Licorice: The medicinal properties are sweet and flat, and it enters the heart, lung, spleen, and stomach meridians. Licorice is sweet, nourishing, moistening, and slow. It is cool when raw, and warm when roasted. It mainly enters the spleen and lung meridians, and also enters the stomach and heart meridians. It can not only replenish qi and replenish the middle, but also relieve pain, moderate the medicinal properties, and also eliminate phlegm and relieve cough, and detoxify. Honey roasting has strong qi-replenishing and relieving effects; raw use can purge fire and detoxify. This product contains triterpenoid saponins and flavonoids. Licorice has the effects of tonifying the spleen and replenishing qi, clearing away heat and detoxifying, eliminating phlegm and relieving cough, relieving pain, and harmonizing various medicines. It is mainly used to treat spleen and stomach weakness, cough with sputum, and poisoning. Modern pharmacological studies have confirmed that licorice also has anti-tumor, anti-inflammatory, enzyme reaction participation, antibacterial, liver protection, hypoglycemic, estrogen-like effects, as well as anti-rheumatic, anti-mental depression, and inhibition of human immunodeficiency virus proliferation.

[0041] Poria: Sweet, light, and neutral in nature. It enters the heart, lung, spleen, and kidney meridians. Poria is sweet and light, and has the effect of penetrating, benefiting, and nourishing. It is neutral in nature and enters the spleen and kidney meridians. It is good at penetrating dampness and promoting water and eliminating water, strengthening the spleen and promoting the transportation of water and dampness. It also enters the heart meridian, is good at calming the heart and soothing the mind, and is suitable for treating those with water and dampness. It is suitable for all cases of water and dampness, stagnant fluid, and spleen deficiency, regardless of cold or heat or both. It is especially good for those with spleen deficiency edema or excessive dampness. This product mainly contains polysaccharides, triterpenoids, sterols, proteins, fats, lecithin, adenine and other ingredients.

[0042] Platycodon chinensis seed: The medicinal property is sweet and neutral. It enters the heart, kidney and large intestine meridians. Platycodon chinensis seed is sweet and nourishing, neutral and slightly cool, and moisturizing. It is a neutral nourishing and moistening product. It enters the heart and kidney meridians, can nourish yin blood and nourish the heart and calm the mind, and is good at treating insomnia caused by deficiency of yin blood; it enters the large intestine meridian, can moisten the intestines and relieve constipation, and can treat constipation caused by deficiency of yin blood. In addition, it can also nourish yin blood and stop sweating, and treat night sweats caused by yin deficiency. This product mainly contains cedarwood alcohol, sitosterol and diterpenoids; it also contains fatty oil, and a small amount of volatile oil, saponin, vitamin A and protein. It has the effects of nourishing the heart and calming the mind, moistening the intestines and relieving constipation, and stopping sweating. It also has the effect of improving the behavior of Alzheimer's disease (AD) model rats and prolonging the sleep time of mice.

[0043] Danshen: bitter can dissipate, slightly cold can clear, enter the heart and liver meridians. It can not only activate blood circulation, remove blood stasis, relieve pain, but also refresh and cool blood, relieve restlessness and eliminate carbuncle. It is mainly used to treat blood stasis, blood heat, heat disturbing the mind, and heat toxic sores, carbuncle, swelling and pain. This product contains quinone components, protocatechuic aldehyde, protocatechuic acid, lactic acid, vitamin E and other ingredients, which have the functions of activating blood circulation, removing blood stasis, relieving pain, clearing the heart and eliminating restlessness, cooling blood and eliminating carbuncle. It also has the effects of improving hemodynamics, anti-thrombosis and anti-lipid peroxidation.

[0044] Ginseng (Adenophora adenophora): sweet, slightly bitter, slightly cold in nature. Enters the lung and stomach meridians. Nourishes yin and clears heat, moistens the lungs and resolves phlegm, benefits the stomach and produces body fluid. Used for chronic cough due to yin deficiency, tuberculosis with sputum and blood, dry cough with little sputum, deficiency-heat throat numbness, and thirst due to loss of body fluid. It also has the effect of improving memory.

[0045] Polygonatum: The medicinal properties are sweet and neutral, and it enters the spleen, lung, and kidney meridians. Polygonatum is moist and sweet, neutral and not biased, and has a mild effect. It enters the spleen, lung, and kidney meridians and is a product for neutralizing qi and yin. It nourishes yin and moistens the lungs, nourishes the kidneys and replenishes essence, and also nourishes the spleen and replenishes qi. It is a good tonic medicine and is good for treating lung and kidney deficiency and qi and yin deficiency. This product contains polysaccharides, saponins, flavonoids and other ingredients, which have the effects of nourishing qi and yin, strengthening the spleen, moistening the lungs, and benefiting the kidneys. It also has pharmacological effects such as anti-tumor, anti-oxidation, anti-aging, anti-fatigue, hypoglycemic and blood lipid, anti-atherosclerosis, bactericidal and anti-inflammatory activity.

[0046] Oyster: salty and moist, cool. Enters the liver and kidney meridians. Astringes yin, suppresses yang, stops sweating, astringes semen, resolves phlegm, and softens hard masses. Treats epilepsy, dizziness, spontaneous sweating, night sweats, spermatorrhea, stranguria, metrorrhagia, leucorrhea, scrofula, and goiter. Used for palpitations, insomnia, dizziness, tinnitus, scrofula, phlegm nuclei, lumps, spontaneous sweating, night sweats, spermatorrhea, metrorrhagia, and stomachache. Calcined oysters are astringent and firm. It also has the effects of improving the body's immunity, enhancing memory, and replenishing energy.

[0047] Longan flesh: sweet, neutral. Enters the heart and spleen meridians. Nourishes the heart and spleen; replenishes qi and blood; calms the mind. Treats deficiency of both the heart and spleen; palpitations caused by insufficient qi and blood; insomnia; forgetfulness; chlorosis due to blood deficiency; irregular menstruation; metrorrhagia. Longan flesh is rich in nutrients, and its main chemical components are sugars, lipids, saponins, polypeptides, polyphenols, volatile components, amino acids and trace elements. It also has anti-stress, anti-anxiety and antioxidant effects.

[0048] Alpinia oxyphylla: pungent, warm; enters the spleen and kidney meridians. This product is pungent, warm, fragrant and dry, warming, tonic and astringent, and enters the spleen and kidney meridians. It warms the kidney, consolidates the essence and reduces urine, and treats spermatorrhea and loose stools caused by kidney deficiency; it also warms the spleen and stops diarrhea, stimulates the appetite and controls saliva, and treats diarrhea, abdominal pain or excessive salivation caused by spleen cold. This product mainly contains volatile oils: eucalyptol, zingiberene, gingerol, etc.; it also contains heptane derivatives, trace elements, vitamins, amino acids, fatty acids and other ingredients. The active ingredients of Alpinia oxyphylla have a clear neuroprotective effect.

[0049] Chinese Yam: Chinese Yam is mild in nature and sweet in taste. It is warm and nourishing without being harsh, slightly fragrant without being dry. It enters the spleen, lung, and kidney meridians. It is a good medicine for nourishing the spleen and stomach, promoting body fluid and benefiting the lungs. It is also a traditional health food. Chinese Yam is rich in trace elements. It has certain antioxidant and Alzheimer's dementia effects.

[0050] Lingzhi: It is mild in nature and sweet in taste. It enters the heart, liver, lung and kidney meridians. Lingzhi can replenish qi and calm the mind, relieve cough and asthma. It is used for symptoms such as restlessness, insomnia and palpitations, lung deficiency cough and asthma, asthenia and shortness of breath, and loss of appetite. Lingzhi contains a variety of chemical components, among which the active ingredients are mainly polysaccharides, triterpenes, nucleosides and sterols. Lingzhi has a wide range of regulatory effects on the cardiovascular system. The adenosine contained in Lingzhi can effectively reduce blood viscosity, inhibit platelet aggregation in the body, increase hemoglobin content, improve blood oxygen supply capacity, and accelerate blood circulation. Lingzhi has a two-way regulatory effect on blood pressure; it can effectively dilate coronary arteries, increase blood flow, improve body microcirculation, increase myocardial oxygen supply, and reduce cholesterol and neutral fat content in the blood.

[0051] Angelica: Angelica is warm, pungent and sweet in nature. It has many functions such as moistening the intestines, treating constipation and irregular menstruation, etc. Therefore, it is often called the "king of medicine" by Chinese medicine practitioners. It also has the functions of increasing blood flow, replenishing blood, protecting the nervous system, and has good anticonvulsant, analgesic and nerve repair effects.

[0052] Dracaena: Sweet, salty, flat, enters the heart and liver meridians. This product is salty and can soften hard masses, sweet and flat, slow in nature, and can stop while moving, and enters the heart and liver meridians. It can not only promote blood circulation, dissipate blood stasis and relieve pain, and treat various symptoms of blood stasis; it can also remove blood stasis, astringe and stop bleeding, and treat traumatic bleeding; it can also promote tissue regeneration, reduce swelling and heal sores, and treat sores that do not heal. Dracaena mainly contains chemical substances such as dracoside, dracorubin, demethyldracoside, flavanols, chalcones, resin acid, rosin acid, isosinic acid, rosin acid, deoxyrosin acid, and rosin acid. It has the effects of promoting blood circulation and relieving pain, removing blood stasis and stopping bleeding, promoting tissue regeneration and heal sores; it is often used for traumatic injuries, heart and abdominal pain, traumatic bleeding, and sores that do not heal. Modern research shows that it also has the effects of anti-thrombosis, improving blood rheology, anti-cardiocerebral ischemia, hemostasis, analgesia, promoting tissue healing, lowering blood lipids, lowering blood sugar, and anti-inflammatory, antioxidant, anti-tumor, and anti-pathogenic microorganisms.

[0053] This Chinese medicine formula with intelligence-enhancing effect is based on the formula concept of Chinese medicine paste formula: according to the formula principle of "monarch, minister, assistant and envoy", a special formula is carefully matched, with Polygala, Acorus gramineus, Cuscuta australis, Astragalus, Schisandra chinensis, Angelica sinensis and Ligusticum chuanxiong as the monarch, mainly for invigorating and replenishing qi; the assistants are Terminalia chebula, Rhodiola rosea, Sanguisorba officinalis and American ginseng, mainly for replenishing blood, improving blood supply and oxygen supply to the brain, and promoting blood circulation in the brain; the assistants are Dragon Bone, Polygala, Acorus gramineus and Ganoderma lucidum, which have the effects of nourishing the heart and kidney, improving intelligence and tranquilizing the mind, and are used for insomnia, forgetfulness, mental fatigue and physical exhaustion caused by disharmony between the heart and kidney, so as to enhance the effect of the monarch formula in treating forgetfulness; the assistants are Ligusticum chuanxiong, Anemarrhena asphodeloides, Poria cocos, Licorice, Longan pulp and Oyster, on the one hand, to enhance the effect of the monarch formula in treating forgetfulness; on the other hand, it has the effects of nourishing blood, calming the mind, clearing away heat and relieving restlessness, and is suitable for insomnia caused by liver blood deficiency and excessive stress. It is supplemented with Alpinia oxyphyllae, which warms the kidneys, improves intelligence, and awakens the brain; it is supplemented with Platycodon grandiflorum and Ginseng to soothe the mind and help memory; it is supplemented with Chinese yam and Polygonatum sibiricum to nourish the kidneys, nourish yin and strengthen the brain; it is supplemented with Salvia miltiorrhiza to promote blood circulation and clear the meridians, relieve depression and soothe the mind; the guiding drug is licorice, which harmonizes the various drugs and corrects the taste; so that the whole formula is nourishing and clearing, nourishing without stagnation. After long-term clinical verification, its efficacy has been clinically verified.

[0054] Example 1

[0055] A traditional Chinese medicine composition for treating Alzheimer's dementia is prepared from the following raw materials by weight: 90 grams of Polygala tenuifolia, 50 grams of Astragalus membranaceus, 50 grams of Cuscuta chinensis, 75 grams of Schisandra chinensis, 75 grams of Acorus calamus, 50 grams of Dragon Bone, 75 grams of Chuanxiong, 10 grams of Sanguisorba officinalis, 40 grams of Terminalia chebula, 75 grams of Anemarrhena asphodeloides, 60 grams of Rhodiola rosea, 75 grams of American ginseng, 25 grams of Licorice, 50 grams of Poria cocos, 60 grams of Angelica sinensis, 40 grams of Ganoderma lucidum, 75 grams of Dioscorea opposita, 25 grams of Platycladus orientalis, 75 grams of Salvia miltiorrhiza, 60 grams of American ginseng, 75 grams of Polygonatum sibiricum, 75 grams of Oyster, 50 grams of Longan pulp and 75 grams of Alpinia oxyphylla.

[0056] The preparation method steps are as follows:

[0057] S1. Wash and dry the above Chinese medicinal materials separately and weigh them according to the weight;

[0058] S2. Use water extraction method to extract the effective ingredients of the following Chinese medicinal materials: Polygala tenuifolia, Astragalus membranaceus, Anemarrhena asphodeloides, Rhodiola rosea, American ginseng, Licorice, Poria cocos, Angelica sinensis, Dioscorea opposita and Polygonatum sibiricum, mix and extract the filtrate to obtain water extraction filtrate, wherein the steps of obtaining the water extraction filtrate are: add 10 times the amount of water, boil and then simmer for 1 hour, filter and obtain the filtrate, repeat the decocting of the residue twice, and combine the filtrate.

[0059] The alcohol extraction method is used to extract the effective ingredients of the following Chinese medicinal materials: Cuscuta chinensis, Schisandra chinensis, Acorus calamus, Ligusticum chuanxiong, Sanguisorba officinalis, Terminalia chebula, Ganoderma lucidum, Platycladus orientalis, Salvia miltiorrhiza, American ginseng, Longan pulp and Alpinia oxyphylla, and the filtrate is extracted after mixing to obtain the alcohol extraction filtrate, wherein the steps of obtaining the alcohol extraction filtrate are: adding 95% ethanol, according to the volume ratio of medicinal materials to ethanol of 1:8, refluxing extraction at 60°C for 2 hours, filtering the filtrate, repeating the extraction once with the residues, and combining the filtrate.

[0060] The dragon bones and oysters were ground separately and sieved into 100 mesh powder.

[0061] S3. The water extraction filtrate, the alcohol extraction filtrate and the powder are mixed and added into a pot and boiled at 60° C. for 30 minutes, and then concentrated under reduced pressure to a thick paste with a relative density of 1.1 to 1.2.

[0062] Example 2

[0063] The invention is prepared from the following raw materials by weight: 100g of Polygala, 55g of Astragalus, 55g of Cuscuta, 80g of Schisandra, 80g of Acorus calamus, 55g of Dragon Bone, 80g of Chuanxiong, 20g of Sanguisorba officinalis, 50g of Terminalia chebula, 80g of Anemarrhena, 70g of Rhodiola rosea, 80g of American ginseng, 30g of Licorice, 55g of Poria, 70g of Angelica sinensis, 45g of Ganoderma lucidum, 80g of Dioscorea opposita, 30g of Platycladus orientalis, 80g of Salvia miltiorrhiza, 70g of Radix Ganodermae, 80g of Polygonatum, 80g of Oyster, 60g of Longan pulp and 80g of Alpinia oxyphylla. The preparation method thereof has the following steps:

[0064] S1. Wash and dry the above Chinese medicinal materials separately and weigh them according to the weight;

[0065] S2. Use water extraction method to extract the effective ingredients of the following Chinese medicinal materials: Polygala tenuifolia, Astragalus membranaceus, Anemarrhena asphodeloides, Rhodiola rosea, American ginseng, Licorice, Poria cocos, Angelica sinensis, Dioscorea opposita and Polygonatum sibiricum, mix and extract the filtrate to obtain water extraction filtrate, wherein the steps of obtaining the water extraction filtrate are: add 10 times the amount of water, boil and then simmer for 1 hour, filter and obtain the filtrate, repeat the decocting of the residue twice, and combine the filtrate.

[0066] The alcohol extraction method is used to extract the effective ingredients of the following Chinese medicinal materials: Cuscuta chinensis, Schisandra chinensis, Acorus calamus, Ligusticum chuanxiong, Sanguisorba officinalis, Terminalia chebula, Ganoderma lucidum, Platycladus orientalis, Salvia miltiorrhiza, American ginseng, Longan pulp and Alpinia oxyphylla, and the filtrate is extracted after mixing to obtain the alcohol extraction filtrate, wherein the steps of obtaining the alcohol extraction filtrate are: adding 95% ethanol, according to the volume ratio of medicinal materials to ethanol of 1:8, refluxing extraction at 60°C for 2 hours, filtering the filtrate, repeating the extraction once with the residues, and combining the filtrate.

[0067] The dragon bones and oysters were ground and sieved into 100-mesh powders.

[0068] S3. The water extraction filtrate, the alcohol extraction filtrate and the powder are mixed and added into a pot and boiled at 60° C. for 30 minutes, and then concentrated under reduced pressure to a thick paste with a relative density of 1.1 to 1.2.

[0069] S4. Evenly mix the thick paste, dextrin and sucrose powder in a mass ratio of 1:1:2, pass through a 14-mesh sieve, make granules, dry at 60°C, and package into 10g granule bags.

[0070] Directions: Take before meals, twice a day, 1 bag each time.

[0071] Example 3

[0072] The invention is prepared from the following raw materials by weight: 95g of Polygala, 55g of Astragalus, 52g of Cuscuta, 78g of Schisandra, 76g of Acorus calamus, 50g of Dragon Bone, 80g of Chuanxiong, 20g of Sanguisorba officinalis, 45g of Terminalia chebula, 80g of Anemarrhena, 60g of Rhodiola rosea, 75g of American ginseng, 30g of Licorice, 50g of Poria, 60g of Angelica sinensis, 40g of Ganoderma lucidum, 80g of Dioscorea opposita, 30g of Platycladus orientalis, 80g of Salvia miltiorrhiza, 70g of Radix Glehniae, 80g of Polygonatum sibiricum, 75g of Oyster, 60g of Longan pulp and 80g of Alpinia oxyphylla. The preparation method thereof has the following steps:

[0073] S1. Wash and dry the above Chinese medicinal materials separately and weigh them according to the weight;

[0074] S2. Use water extraction method to extract the effective ingredients of the following Chinese medicinal materials: Polygala tenuifolia, Astragalus membranaceus, Anemarrhena asphodeloides, Rhodiola rosea, American ginseng, Licorice, Poria cocos, Angelica sinensis, Dioscorea opposita and Polygonatum sibiricum, mix and extract the filtrate to obtain water extraction filtrate, wherein the steps of obtaining the water extraction filtrate are: add 10 times the amount of water, boil and then simmer for 1 hour, filter and obtain the filtrate, repeat the decocting of the residue twice, and combine the filtrate.

[0075] The alcohol extraction method is used to extract the effective ingredients of the following Chinese medicinal materials: Cuscuta chinensis, Schisandra chinensis, Acorus calamus, Ligusticum chuanxiong, Sanguisorba officinalis, Terminalia chebula, Ganoderma lucidum, Platycladus orientalis, Salvia miltiorrhiza, American ginseng, Longan pulp and Alpinia oxyphylla, and the filtrate is extracted after mixing to obtain the alcohol extraction filtrate, wherein the steps of obtaining the alcohol extraction filtrate are: adding 95% ethanol, according to the volume ratio of medicinal materials to ethanol of 1:8, refluxing extraction at 60°C for 2 hours, filtering the filtrate, repeating the extraction once with the residues, and combining the filtrate.

[0076] The dragon bones and oysters were ground separately and sieved into 100 mesh powder.

[0077] S3. The water extraction filtrate, the alcohol extraction filtrate and the powder are mixed and added into a pot and boiled at 60° C. for 30 minutes, and then concentrated under reduced pressure to a thick paste with a relative density of 1.1 to 1.2.

[0078] S4. Evenly mix thick paste and water in a mass ratio of 1:1.5, and boil to obtain a decoction, which is packaged into 200 ml bags.

[0079] Directions: Take before meals, twice a day, 1 bag each time.

[0080] Example 4

[0081] It is made from the following raw materials by weight: 100 grams of Polygala, 50 grams of Astragalus, 50 grams of Cuscuta, 80 grams of Schisandra, 75 grams of Acorus calamus, 50 grams of Dragon Bone, 76 grams of Chuanxiong, 15 grams of Sanguisorba officinalis, 45 grams of Terminalia chebula, 80 grams of Anemarrhena, 60 grams of Rhodiola rosea, 80 grams of American ginseng, 25 grams of Licorice, 50 grams of Poria, 65 grams of Angelica sinensis, 45 grams of Ganoderma lucidum, 80 grams of Dioscorea opposita, 25 grams of Platycladus orientalis, 75 grams of Salvia miltiorrhiza, 65 grams of American ginseng, 80 grams of Polygonatum, 80 grams of Oyster, 50 grams of Longan pulp and 80 grams of Alpinia oxyphylla.

[0082] The preparation method steps are as follows:

[0083] S1. Wash and dry the above Chinese medicinal materials separately and weigh them according to the weight;

[0084] S2. Use water extraction method to extract the effective ingredients of the following Chinese medicinal materials: Polygala tenuifolia, Astragalus membranaceus, Anemarrhena asphodeloides, Rhodiola rosea, American ginseng, Licorice, Poria cocos, Angelica sinensis, Dioscorea opposita and Polygonatum sibiricum, mix and extract the filtrate to obtain water extraction filtrate, wherein the steps of obtaining the water extraction filtrate are: add 10 times the amount of water, boil and then simmer for 1 hour, filter and obtain the filtrate, repeat the decocting of the residue twice, and combine the filtrate.

[0085] The alcohol extraction method is used to extract the effective ingredients of the following Chinese medicinal materials: Cuscuta chinensis, Schisandra chinensis, Acorus calamus, Ligusticum chuanxiong, Sanguisorba officinalis, Terminalia chebula, Ganoderma lucidum, Platycladus orientalis, Salvia miltiorrhiza, American ginseng, Longan pulp and Alpinia oxyphylla, and the filtrate is extracted after mixing to obtain the alcohol extraction filtrate, wherein the steps of obtaining the alcohol extraction filtrate are: adding 95% ethanol, according to the volume ratio of medicinal materials to ethanol of 1:8, refluxing extraction at 60°C for 2 hours, filtering the filtrate, repeating the extraction once with the residues, and combining the filtrate.

[0086] The dragon bones and oysters were ground and sieved into 100-mesh powders.

[0087] S3. The water extraction filtrate, the alcohol extraction filtrate and the powder are mixed and added into a pot and boiled at 60° C. for 30 minutes, and then concentrated under reduced pressure to a thick paste with a relative density of 1.1 to 1.2.

[0088] S4. The thick paste is placed under vacuum drying at 50°C to obtain dry powder, and the powder is filled into a capsule shell to prepare a capsule.

[0089] Dosage: Take before meals, 3 times a day, 3-5 pills each time, each pill weighs about 0.4g.

[0090] Since the therapeutic effects of the Chinese medicine compositions for treating Alzheimer's dementia provided in Examples 1-4 are basically the same, only the thick paste prepared in Example 2 is used to illustrate the effects below, wherein the test conditions and results of the pharmacological toxicity experiment are as follows:

[0091] 1. The thick paste of Example 1 was used as the experimental material and verified by pharmacological toxicity experiment

[0092] Pharmacological toxicity experiments include acute toxicity experiments and long-term toxicity experiments. Acute toxicity experiments are as follows:

[0093] 1. Experimental methods

[0094] The depilatory agent was evenly applied on both sides of the spine of the guinea pig back, and the depilatory area was about 20 square centimeters. The depilatory agent was washed off and the guinea pigs were returned to the cage for observation for 24 hours. Each group of guinea pigs was respectively coated with 3g, 9g and 15g of the thick paste of the present invention, twice a day, for one week. After the experiment, the guinea pigs were killed, and the heart, liver, kidney and depilated skin were subjected to pathological examination.

[0095] 2. Results

[0096] No edema, congestion, erythema, hemorrhage or ulcer was found in the depilated area of ​​the trunk of the three groups of guinea pigs. There was no significant difference in hair color, food intake, limb activity, etc. between the guinea pigs in the drug group and the control group. In the pathological histological examination, there was no significant difference in the heart, liver, kidney and depilated skin between the drug group and the control group.

[0097] The results show that the invention has no local irritation and no systemic toxicity, indicating that the preparation of the invention is safe to use.

[0098] The long-term toxicity experiments are as follows:

[0099] 1. Experimental methods

[0100] The guinea pigs were randomly divided into 4 groups, each with 15, and the depilatory agent was evenly applied on both sides of the spine of the back of the guinea pigs to make the depilatory area about 20 square centimeters. The depilatory agent was washed off, and after 24 hours of observation, each group of guinea pigs were respectively coated with 0.2, 0.4 and 0.8 ml of the thick paste of the present invention, twice a day, for 30 consecutive days, and the general conditions of the guinea pigs were observed. After the experiment, the animals were killed for hematology, blood biochemistry and pathology examinations.

[0101] 2. Results

[0102] In the above three groups of guinea pigs, no edema, congestion, erythema, hemorrhage and ulcer were found in the local skin. In the pathological histological examination, no obvious lesions were found in the heart, liver, kidney and local skin of each experimental group. It is suggested that long-term use of the present invention has no obvious toxic effects on the local skin and important organs of the whole body. The test results show that the present invention is safe.

[0103] Cumulative toxicity experiments:

[0104] The thick paste of the present invention was used for 15 weeks (1.0 ml / 100 g body weight, twice a day) for mice at 7.83, 19.02 and 42.98 g crude drug / kg and stopped for 3 weeks. The results showed that the present invention had no significant effect on the hair, behavior, defecation, body weight, organ weight, blood items, liver and kidney function, blood sugar, blood lipid and other indicators of the rats, and no abnormal changes were found in the organs by naked eyes. The results of histological examination showed that after 15 weeks of medication and 3 weeks of withdrawal, there were no significant changes in the organs of the rats. This shows that the present invention has low toxicity to rats after long-term medication, no abnormal reaction after withdrawal, and safe application.

[0105] 2. Clinical Trials

[0106] 1. Data of test subjects

[0107] 50 patients: aged 64-81 years, average age 72 years; 28 males, 22 females; duration of illness 1-10 years, average 5 years; in line with the "Chinese Classification and Diagnostic Criteria for Mental Disorders"; clinical manifestations of memory loss, decreased comprehension and judgment. All cases were confirmed by the Mini-Mental State Examination (MMSE), Hasegawa Dementia Rating Scale (HDS), and Cognitive Assessment Scale (CAS).

[0108] 2. Treatment method and efficacy evaluation criteria: Take the capsules of Example 4 orally before meals, 3 times a day, 3-5 capsules each time, each capsule weighs about 0.4 g, and one course of treatment is two months.

[0109] The therapeutic effect was evaluated based on the increase or decrease in the Mini-Mental State Examination (MMSE) scores after treatment.

[0110] Markedly effective: score increase ≥ 8 points, or reaching 28 points; effective: score increase 4-7 points; ineffective: score increase ≤ 3 points; worsening: score increase < 0 points.

[0111] 3. Observation results

[0112]

[0113] The results are shown in the table above. After taking the Chinese medicine composition capsules of the present invention for 62 days, 84% of the patients achieved remarkable and effective results; after taking the Chinese medicine composition capsules of the present invention orally for 125 days, 96% of the patients achieved remarkable and effective results. After taking the Chinese medicine composition capsules of the present invention for one course of treatment, the mental state of most patients has been significantly improved, their attention has been more focused, and their memory has been significantly improved.

[0114] 4. Observation results of toxic and side effects: None of the 50 patients treated had any adverse reactions, and the disease progression rate was 0, indicating that the Chinese medicine composition capsule of the present invention is safe for human body.

[0115] According to the above method, the clinical efficacy of the pharmaceutical preparations described in Examples 1 to 3 was tested respectively, and the results were similar to the effect of the Chinese medicine composition capsule described in Example 7, and the clinical effect of improving memory was significant. The above clinical observation results show that the pharmaceutical preparation of the Chinese medicine composition of the present invention has a significant effect on the treatment of Alzheimer's dementia, has no toxic side effects, no drug dependence, is safe for medication, and has practical clinical significance. Therefore, the Chinese medicine composition of the present invention can be effectively applied to Alzheimer's dementia, and has a significant effect.

[0116] The present invention provides the preferred specific embodiments of the present invention described in detail above. It should be understood that a person skilled in the art can make many modifications and changes based on the concept of the present invention without creative work. Therefore, any technical solution that can be obtained by a person skilled in the art through logical analysis, reasoning or limited experiments based on the concept of the present invention on the basis of the prior art should be within the scope of protection determined by the claims.

Claims

1. A Chinese medicine composition for treating Alzheimer's dementia, characterized in that: The invention is prepared from the following raw materials in parts by weight: 90-100 parts of Polygala tenuifolia, 50-55 parts of Astragalus membranaceus, 50-55 parts of Cuscuta chinensis, 75-80 parts of Schisandra chinensis, 75-80 parts of Acorus calamus, 50-55 parts of Dragon's bone, 75-80 parts of Chuanxiong, 10-20 parts of Sanguisorba officinalis, 40-50 parts of Terminalia chebula, 75-80 parts of Anemarrhena asphodeloides, 60-70 parts of Rhodiola rosea, 75-80 parts of American ginseng, 25-30 parts of Licorice root, 50-55 parts of Poria cocos, 60-70 parts of Angelica sinensis, 40-45 parts of Ganoderma lucidum, 75-80 parts of Dioscorea opposita, 25-30 parts of Platycladus orientalis seeds, 75-80 parts of Salvia miltiorrhiza, 60-70 parts of American ginseng, 75-80 parts of Polygonatum sibiricum, 75-80 parts of Oyster, 50-60 parts of Longan pulp and 75-80 parts of Alpinia oxyphylla seeds.

2. The Chinese medicine composition for treating Alzheimer's dementia as claimed in claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 90 parts of Polygala tenuifolia, 50 parts of Astragalus membranaceus, 50 parts of Cuscuta chinensis, 75 parts of Schisandra chinensis, 75 parts of Acorus calamus, 50 parts of Dragon Bone, 75 parts of Ligusticum chuanxiong, 10 parts of Sanguisorba officinalis, 40 parts of Terminalia chebula, 75 parts of Anemarrhena asphodeloides, 60 parts of Rhodiola rosea, 75 parts of American ginseng, 25 parts of Licorice, 50 parts of Poria cocos, 60 parts of Angelica sinensis, 40 parts of Ganoderma lucidum, 75 parts of Dioscorea opposita, 25 parts of Platycladus orientalis seeds, 75 parts of Salvia miltiorrhiza, 60 parts of American ginseng, 75 parts of Polygonatum sibiricum, 75 parts of Oyster, 50 parts of Longan pulp and 75 parts of Alpinia oxyphylla seeds.

3. The Chinese medicine composition for treating Alzheimer's dementia as claimed in claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 100 parts of Polygala tenuifolia, 55 parts of Astragalus membranaceus, 55 parts of Cuscuta chinensis, 80 parts of Schisandra chinensis, 80 parts of Acorus calamus, 55 parts of Dragon Bone, 80 parts of Ligusticum chuanxiong, 20 parts of Sanguisorba officinalis, 50 parts of Terminalia chebula, 80 parts of Anemarrhena asphodeloides, 70 parts of Rhodiola rosea, 80 parts of American ginseng, 30 parts of Licorice, 55 parts of Poria cocos, 70 parts of Angelica sinensis, 45 parts of Ganoderma lucidum, 80 parts of Dioscorea opposita, 30 parts of Platycladus orientalis, 80 parts of Salvia miltiorrhiza, 70 parts of American ginseng, 80 parts of Polygonatum sibiricum, 80 parts of Oyster, 60 parts of Longan pulp and 80 parts of Alpinia oxyphylla.

4. The Chinese medicine composition for treating Alzheimer's dementia as claimed in claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 95 parts of Polygala tenuifolia, 55 parts of Astragalus membranaceus, 52 parts of Cuscuta chinensis, 78 parts of Schisandra chinensis, 76 parts of Acorus calamus, 50 parts of Dragon Bone, 80 parts of Ligusticum chuanxiong, 20 parts of Sanguisorba officinalis, 45 parts of Terminalia chebula, 80 parts of Anemarrhena asphodeloides, 60 parts of Rhodiola rosea, 75 parts of American ginseng, 30 parts of Licorice, 50 parts of Poria cocos, 60 parts of Angelica sinensis, 40 parts of Ganoderma lucidum, 80 parts of Dioscorea opposita, 30 parts of Platycladus orientalis seeds, 80 parts of Salvia miltiorrhiza, 70 parts of American ginseng, 80 parts of Polygonatum sibiricum, 75 parts of Oyster, 60 parts of Longan pulp and 80 parts of Alpinia oxyphylla seeds.

5. The Chinese medicine composition for treating Alzheimer's dementia as claimed in claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 100 parts of Polygala tenuifolia, 50 parts of Astragalus membranaceus, 50 parts of Cuscuta chinensis, 80 parts of Schisandra chinensis, 75 parts of Acorus calamus, 50 parts of Dragon's bone, 76 parts of Ligusticum chuanxiong, 15 parts of Sanguisorba officinalis, 45 parts of Terminalia chebula, 80 parts of Anemarrhena asphodeloides, 60 parts of Rhodiola rosea, 80 parts of American ginseng, 25 parts of Licorice, 50 parts of Poria cocos, 65 parts of Angelica sinensis, 45 parts of Ganoderma lucidum, 80 parts of Dioscorea opposita, 25 parts of Platycladus orientalis seeds, 75 parts of Salvia miltiorrhiza, 65 parts of American ginseng, 80 parts of Polygonatum sibiricum, 80 parts of Oyster, 50 parts of Longan pulp and 80 parts of Alpinia oxyphylla seeds.

6. A method for preparing a Chinese medicine composition for treating Alzheimer's dementia as claimed in any one of claims 1 to 5, characterized in that: The following steps are involved: S1. Wash and dry the above Chinese medicinal materials separately and weigh them according to the weight; S2. extracting the effective components of the following Chinese medicinal materials by water extraction: Polygala, Astragalus, Anemarrhena, Rhodiola, American ginseng, Licorice, Poria, Angelica, Dioscorea and Polygonatum, mixing and extracting the filtrate to obtain a water extraction filtrate; The effective components of the following Chinese medicinal materials are extracted by alcohol extraction: Cuscuta chinensis, Schisandra chinensis, Acorus calamus, Ligusticum chuanxiong, Sanguisorba officinalis, Terminalia chebula, Ganoderma lucidum, Platycladus orientalis, Salvia miltiorrhiza, American ginseng, Longan pulp and Alpinia oxyphylla, and the mixture is mixed to obtain the alcohol extraction filtrate; Grind the dragon bones and oysters separately and sieve them into 100-mesh powder; S3. The water extraction filtrate, the alcohol extraction filtrate and the powder are mixed and added into a pot and boiled at 60° C. for 30 minutes, and then concentrated under reduced pressure to a thick paste with a relative density of 1.1 to 1.

2.

7. The method for preparing a Chinese medicine composition for treating Alzheimer's dementia as claimed in claim 6, characterized in that: In step S2, the steps of obtaining the water extraction filtrate are: adding 10 times the amount of water, boiling and then simmering for 1 hour, filtering the filtrate, repeating the decocting of the medicinal residue twice, and combining the filtrate.

8. The method for preparing a Chinese medicine composition for treating Alzheimer's dementia as claimed in claim 6, characterized in that: In step S2, the step of obtaining the alcohol extraction filtrate is: adding 95% ethanol, according to the volume ratio of medicinal material to ethanol of 1:8, reflux extraction at 60°C for 2 hours, filtering the filtrate, repeating the extraction of the medicinal residue once, and combining the filtrate.

9. The method for preparing the Chinese medicine composition for treating Alzheimer's dementia according to claim 6, characterized in that: The thick paste is further prepared into powder, decoction, granules, tablets or capsules.

10. The method for preparing the Chinese medicine composition for treating Alzheimer's dementia according to claim 9, characterized in that: The thick paste is further prepared into powder by vacuum drying the thick paste at 50° C. to obtain dry powder.

Citation Information

Patent Citations

  • Traditional Chinese medicine for treating senile dementia

    CN104189700A