A Chinese medicine composition for treating Alzheimer's disease and its preparation method and application

Abstract

The present invention provides a Chinese medicine composition for treating or preventing Alzheimer's disease, and its preparation method and application, wherein the Chinese medicine composition comprises the following raw materials in parts by mass: 10-20 parts of ginseng, 10-20 parts of polygala, 10-20 parts of calamus, 10-20 parts of tuckahoe, 10-20 parts of yam, 10-20 parts of polygonatum, 10-20 parts of green tea pigments and 10-20 parts of quercetin, and optionally comprises 0.1-0.5 parts of black pepper. The Chinese medicine composition of the present invention has a significant therapeutic effect on 5XFAD transgenic AD mice, which is specifically manifested in that daily oral administration of the Chinese medicine composition of the present invention improves the spatial learning and memory disorders of dementia mice, reduces the deposition of amyloid plaques in the dentate gyrus of the hippocampus of mice, and significantly inhibits the generation of Aβ without causing liver and kidney toxicity and weight loss. Therefore, the Chinese medicine composition of the present invention is a safe and effective method for treating AD.

Description

Technical Field

[0001] The invention relates to a traditional Chinese medicine composition for treating or preventing Alzheimer's disease, and a preparation method and application thereof. Background Art

[0002] Alzheimer's disease (AD) is a progressive neurodegenerative disease with an insidious onset. It is the most common type of senile dementia, characterized by neuropsychiatric symptoms such as progressive memory impairment, cognitive dysfunction, language impairment, executive dysfunction, and personality changes. The incidence of AD increases with age, with the incidence rate of 3%-5% in people aged 65 and 30%-40% in people aged 85. With the increase in life expectancy in today's society, the incidence of AD is on the rise. It is predicted that there will be about 150 million AD patients worldwide in 2050. AD has become an important factor that endangers the lives of the elderly and restricts social development. The cause of AD is still unknown. Its main characteristic lesions are abnormal accumulation of amyloid plaques and neurofibrillary tangles, inflammatory cell infiltration, and neuronal loss with glial cell proliferation. At present, the drugs used to treat AD mainly include two types of Western medicine, cholinesterase inhibitors and excitatory amino acid receptor antagonists, but they can only improve patients' cognitive impairment in the short term, and cannot block the occurrence of AD or delay the progression of the disease. In addition, some drugs have strong liver toxicity and are expensive, making it difficult for patients to take them for a long time. Therefore, developing a new method for preventing and treating AD that is safe, effective and inexpensive will help promote the development of geriatric medicine and benefit all mankind.

[0003] Traditional Chinese medicine treatment has the characteristics of multi-pathway, multi-link, and multi-target overall regulation. It has a unique natural advantage in preventing and treating AD with complex causes and prolonged course. Moreover, because it is made from natural Chinese herbal medicine, its toxic side effects are less than those of Western medicine. A large amount of research data has shown that traditional Chinese medicine can improve cognitive impairment and alleviate AD-related pathological symptoms, and has great development potential in the treatment of AD. Summary of the invention

[0004] The purpose of the present invention is to develop a Chinese medicine composition that can effectively prevent and treat Alzheimer's disease.

[0005] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0006] A traditional Chinese medicine composition for preventing and treating Alzheimer's disease comprises the following raw materials in parts by mass: 10-20 parts of ginseng, 10-20 parts of polygala, 10-20 parts of calamus, 10-20 parts of tuckahoe, 10-20 parts of yam, 10-20 parts of polygonatum, 10-20 parts of green tea extract and 10-20 parts of quercetin.

[0007] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-15 parts of ginseng, 10-15 parts of polygala, 10-15 parts of calamus, 10-15 parts of poria, 10-15 parts of yam, 10-15 parts of polygonatum, 10-15 parts of green tea extracts and 10-15 parts of quercetin.

[0008] Preferably, the Chinese medicine composition for preventing and treating Alzheimer's disease further comprises 0.1-0.5 parts of black pepper powder, more preferably 0.1-0.2 parts.

[0009] In some embodiments of the present invention, the Chinese medicine composition may include concentrated Chinese medicine granules and / or Chinese medicine extracts of the raw material medicine. Generally, the correspondence between various concentrated Chinese medicine granules and Chinese medicine extracts and the raw material medicine is as follows:

[0010] Concentrated Chinese herbal ginseng 1g = raw material 5g

[0011] Concentrated Chinese herbal medicine Polygala 1g = raw material 10g

[0012] Concentrated Chinese herbal medicine Acorus calamus 1g = raw material 10g

[0013] Concentrated Chinese medicine Poria 1g = raw material 20g

[0014] Concentrated Chinese herbal medicine yam 1g = raw material medicine 20g

[0015] Concentrated Chinese medicine Polygonatum sibiricum 1g = raw material 20g

[0016] Chinese herbal medicine extract green tea extract 1g = raw material 10g

[0017] Chinese herbal medicine extract quercetin 1g = raw material 10g.

[0018] Furthermore, the above-mentioned Chinese medicine composition can be a decoction, granules, powder, capsule, tablet, mixture or oral liquid.

[0019] On the other hand, the present invention also provides a method for preparing a Chinese medicine composition for preventing and treating Alzheimer's disease, comprising the following steps:

[0020] (1) Weigh concentrated Chinese medicinal materials: ginseng, polygala, calamus, poria, yam and polygonatum, and Chinese medicinal extracts: green tea extract and quercetin, and mix them;

[0021] (2) Optionally, black pepper powder is added to the Chinese medicine mixture obtained in step (1), and then purified water is added to dissolve it.

[0022] According to the preparation method provided by the present invention, in step (1), concentrated Chinese medicine is weighed according to the following weight parts: 2-4 parts of ginseng, 1-2 parts of polygala, 1-2 parts of calamus, 0.5-1 parts of tuckahoe, 0.5-1 parts of yam and 0.5-1 parts of polygonatum; and Chinese medicine extracts: 1-2 parts of green tea extract and 1-2 parts of quercetin.

[0023] Preferably, in step (1), the concentrated Chinese medicine is weighed according to the following weight parts: 2-4 parts of ginseng, 1-2 parts of polygala, 1-2 parts of calamus, 0.5-1 parts of tuckahoe, 0.5-1 parts of yam and 0.5-1 parts of polygonatum; and the Chinese medicine extract: 1-2 parts of green tea extract and 1-2 parts of quercetin.

[0024] According to the preparation method provided by the present invention, the amount of black pepper powder added in step (2) is 0.1-0.5 parts, preferably 0.1-0.2 parts.

[0025] According to the preparation method provided by the present invention, in step (2), the amount of pure water added is 150-300 ml, preferably 180-220 ml, relative to 100 g of the traditional Chinese medicine mixture.

[0026] Preferably, step (2) comprises adding pure water and then placing the mixture in a water bath at 50-60°C for 30 minutes to 1 hour to promote dissolution, and then storing the mixture in a refrigerator at 0-5°C.

[0027] According to traditional Chinese medicine theory, Alzheimer's disease is often manifested clinically as a complex syndrome of deficiency in the root and excess in the superficial, or a mixture of deficiency and excess. Deficiency syndromes can be seen in kidney deficiency and marrow deficiency, heart and liver yin deficiency, heart and spleen deficiency, etc., while excess syndromes can be seen in phlegm blocking the meridians, qi stagnation and blood stasis, etc. Epidemiological surveys and studies have found that kidney deficiency always runs through the development of Alzheimer's disease, while phlegm and blood stasis are the main pathological factors. With the development of new technologies in modern Chinese medicine, technologies such as drug component analysis, active ingredient purification, pharmacokinetic and metabolic monitoring, drug targeting and interaction analysis have gradually become standardized and simplified, laying a technical foundation for the clinical application of Chinese medicine. Although modern medicine has not been able to clarify the pathogenesis of Alzheimer's disease, researchers believe that abnormal accumulation of amyloid plaques and neurofibrillary tangles, inflammatory cell infiltration, oxidative activation and neuronal damage in brain tissue can accelerate the occurrence and development of the disease, while inhibiting these pathological processes may block or delay the progression of the disease.

[0028] The Chinese medicine composition of the present invention is based on the understanding of the cause of Alzheimer's disease in traditional Chinese medicine theory, the analysis of the efficacy of Chinese medicine according to new modern Chinese medicine technologies, and the research progress of modern medicine on the pathological mechanism of Alzheimer's disease. It is prepared by screening and combining a large number of Chinese medicines.

[0029] Further, the efficacy of the Chinese medicine components of the present invention is described as follows:

[0030] Ginseng: Shennong's Herbal Classic states that "ginseng is sweet, slightly cold, and can nourish the five internal organs, calm the spirit, stabilize the soul, stop panic, remove evil spirits, improve eyesight, and improve intelligence". Modern research has found that ginseng can relieve fatigue, restore vitality, improve learning and memory, resist oxidation, resist aging, protect nerves, and improve cognitive impairment.

[0031] Polygala: calms the mind, improves intelligence, removes phlegm, and reduces swelling. It is used for insomnia, dreaminess, forgetfulness, palpitations, confusion, and coughing up phlegm caused by disharmony between the heart and kidney. "Compendium of Materia Medica" says: It is good at strengthening the will and improving the essence, and treating forgetfulness.

[0032] Acorus calamus: It can dissipate dampness and stimulate appetite, open the orifices and dispel phlegm, and refresh the mind and improve intelligence. The Shennong's Herbal Classic states that it "treats wind-cold-dampness arthralgia, cough and reverse breathing, opens the heart orifices, nourishes the five internal organs, opens the nine orifices, brightens the eyes and ears, and makes sounds. Long-term use will make the body lighter, prevent forgetfulness, and prevent confusion, and prolong life."

[0033] Poria: It tastes sweet, light and neutral in nature. It has the functions of promoting diuresis and eliminating dampness, benefiting the spleen and stomach, and calming the mind. Modern medical research has found that Poria has the functions of enhancing the body's immunity, anti-tumor and protecting the liver.

[0034] Yam: sweet in taste, neutral in nature, enters the lung, spleen, and kidney meridians, neither dry nor greasy; it has the effects of strengthening the spleen and lungs, benefiting the stomach and kidneys, consolidating the kidneys and improving essence, improving hearing and eyesight, helping the five internal organs, strengthening the tendons and bones, improving will and calming the mind, and prolonging life.

[0035] Polygonatum: sweet in taste, neutral in nature, enters the lung, spleen, and kidney meridians; can nourish the kidneys and lungs, tonify the spleen and replenish qi; has antioxidant, anti-fatigue, anti-aging, immune function and metabolism enhancing effects.

[0036] Green tea polyphenols: It has strong antioxidant effects, and can also resist aging, enhance metabolism, lower blood lipids and blood pressure, and stop diarrhea and act as a diuretic.

[0037] Quercetin: It has good expectorant, antitussive and antiasthmatic effects. It also has the effects of lowering blood pressure, reducing swelling and promoting diuresis, clearing away heat and detoxifying, and anti-oxidation, anti-inflammatory and anti-allergic. It can be used to treat symptoms such as forgetfulness, memory loss, and chronic bronchitis.

[0038] Black pepper: warms the middle and dispels cold, relieves qi, and eliminates phlegm. It has anti-inflammatory, antioxidant, antidepressant and cognitive enhancement effects. It can treat cold pain in the abdomen, vomiting, nausea and loss of appetite caused by stomach cold, as well as phlegm and qi stagnation, epilepsy caused by blinding the clear mind. Experiments have shown that black pepper can significantly improve the absorption of green tea tannins and quercetin in the intestines.

[0039] The beneficial effects of the present invention compared with the prior art are:

[0040] The Chinese medicine composition of the present invention is screened on the basis of traditional Chinese medicine theory combined with modern medical research results. It takes invigorating the spleen and resolving phlegm, tonifying the kidney and replenishing qi as the main treatment means, supplemented by anti-oxidation, anti-aging, improving the body's immunity and enhancing metabolism, etc., to carry out multi-target, multi-link and multi-pathway holistic treatment, has the effect of significantly alleviating the pathological changes of Alzheimer's disease and improving cognitive impairment, and has no obvious toxic and side effects, and has high development value.

[0041] In addition, the raw material drug components in the present invention are all commercially available concentrated granules of Chinese herbal medicine extracts, and no complicated and time-consuming purification process is required during preparation. The method is simple and convenient, and is conducive to large-scale production. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] The embodiments of the present invention are described in detail below with reference to the accompanying drawings, wherein:

[0043] Figure 1 The escape latency data of mice in different groups (6 months old) in the navigation test; **: P < 0.01; ****: P < 0.0001.

[0044] Figure 2 The time (left), average swimming speed (middle) and distance (right) of mice in different groups (6 months old) in the target quadrant in the spatial exploration experiment; *: P < 0.05; **: P < 0.01; ***: P < 0.001.

[0045] Figure 3 Representative swimming paths of mice (6 months old) in different groups in the spatial exploration experiment; the dotted circle represents the location of the platform.

[0046] Figure 4 The escape latency data of mice in different groups (8 months old) in (A) the positioning navigation test; (B) the time they stayed in the target quadrant in the spatial exploration test.

[0047] Figure 5 Representative microscopic images of amyloid plaque deposition in the dentate gyrus region of the hippocampus of 6-month-old mice (A) and 8-month-old mice (B) from different groups.

[0048] Figure 6 Statistical results of amyloid plaque deposition area in the dentate gyrus of the hippocampus of 6-month-old mice (left) and 8-month-old mice (right) in different groups; *: P < 0.05; **: P < 0.01.

[0049] Figure 7The effect of the Chinese medicine composition on the expression level of proteins related to the β-amyloid protein signaling pathway; *: P < 0.05; **: P < 0.01; ns: not statistically significant.

[0050] Figure 8 Representative microscopic images of hematoxylin and eosin staining of the liver (A) and kidney (B) of mice from different groups (8 months old).

[0051] Fig. 9 Comparison of body weights of 6-month-old mice (A) and 8-month-old mice (B) in different groups. DETAILED DESCRIPTION

[0052] The present invention is further described in detail below in conjunction with specific embodiments. The given examples are only for illustrating the present invention, rather than for limiting the scope of the present invention.

[0053] All animal experiments performed in the following examples were approved by the Hong Kong University Animal Use and Teaching Research Committee (CULATR-5196-19). The AD model mice used in the examples were 5XFAD transgenic mice, which express five familial AD mutations, namely APP K670N / M671L (Swedish), I716V (Florida), V717I (London), PS1 M146L and L286V, purchased from Jackson Laboratory. The feeding, care and handling of all animals in the examples were in accordance with the Guide for the Care and Use of Laboratory Animals.

[0054] The Chinese herbal extracts used in the examples were purchased from Hong Kong Excellence Concentrated Chinese Medicine Co., Ltd. (Hong Kong, China) and supplied in the form of dry powder.

[0055] Example 1: Preparation of the Chinese medicine composition of the present invention

[0056] Weigh the concentrated powders of ginseng, polygala, calamus, poria, yam, polygonatum, green tea extract and quercetin in a weight ratio of 1:1:1:1:1:1:1:1, and mix the weighed components evenly. Weigh 6 grams of the above Chinese medicine mixture, add 10 mg of black pepper powder, then add 11.5 ml of double distilled water, place in a 55°C water bath for 30 minutes to 1 hour to promote dissolution, and finally store the evenly dissolved Chinese medicine mixture in a refrigerator at 4°C.

[0057] Example 2: Experimental process

[0058] 2.1 Dosage regimen

[0059] The 3-month-old male 5XFAD transgenic mice were randomly divided into 3 groups: the control group: double distilled water was given by gavage once a day for 3 or 5 months; the low-dose Chinese medicine treatment group: the low-dose Chinese medicine composition prepared in Example 1 (3.9 g / kg / d) was given by gavage once a day for 3 or 5 months; the high-dose Chinese medicine treatment group: the high-dose Chinese medicine composition prepared in Example 1 (7.8 g / kg / d) was given by gavage once a day for 3 or 5 months. In order to improve the credibility of the experimental results, two additional blank control groups were set up in this example: 3-month-old male wild-type mice (normal group) without any treatment and 5XFAD transgenic mice (model group). All the above experimental mice were tested for relevant indicators when they were 6 or 8 months old.

[0060] 2.2 Morris water maze test

[0061] The Morris water maze (MWM) test mainly includes two parts: positioning navigation experiment and space exploration experiment. During the experiment, the circular pool was divided into four quadrants, and a circular platform was placed at the diagonal center of the fourth quadrant. Water about 20 cm deep was poured into the pool, so that the water depth was about 1 cm higher than the platform, and milk powder was added and stirred evenly to make the water opaque and milky white. Positioning navigation experiment: The mouse was placed in the water facing the pool wall at the specified entry point in quadrants 1, 2, and 4. Within 60 seconds, if the mouse found the platform, it was allowed to stay on the platform for 15 seconds; if the mouse failed to find the platform, it was artificially placed on the platform for 15 seconds to enhance memory. The time taken by the mouse to find the platform was recorded as the escape latency. This part of the experiment was carried out for 5 consecutive days, with 4 training sessions per day and 30 minutes between two training sessions. Space exploration experiment: The platform was removed, and the mouse was placed in the pool at the same entry point in quadrant 2. The mouse's stay time and distance in the target quadrant (quadrant 4) within 60 seconds, as well as the swimming trajectory in the pool were recorded. When conducting relevant statistical analysis, the data of mice whose average swimming speed during the experiment was lower than 7 cm per second must be eliminated.

[0062] 2.3 Collection and processing of mouse brain tissue specimens

[0063] After completing the MWM test, all experimental mice were quickly decapitated at low temperature to remove the whole brain, which was then cut into two equal halves along the midline of the brain. The right hemisphere was fixed in 4% paraformaldehyde for subsequent immunohistochemical analysis, while the left hemisphere was stored in liquid nitrogen for subsequent biochemical experimental analysis.

[0064] 2.4 Immunohistochemical analysis

[0065] After paraffin-embedded brain tissue sections were hydrated, they were placed in citrate buffer and boiled at 98°C for 10 minutes to retrieve antigens. After cooling at room temperature for 1 hour, they were blocked with 5% BSA (5% w / v BSA in 1× TBST) at room temperature for 1 hour, and then incubated with β-amyloid antibody (6E10, Biolegend) at 4°C overnight. After washing away nonspecifically bound primary antibodies with PBS, horseradish peroxidase-labeled secondary antibodies were added and incubated at room temperature for 1 hour. Finally, 3,3'-diaminobenzidine (DAB) was used for color development, and images were captured using an Olympus BX51 optical microscope (Olympus, Japan).

[0066] 2.5 Western blotting

[0067] Hippocampal tissue was isolated and homogenized with RIPA lysis buffer to extract total protein. After the concentration of the protein supernatant was measured, 20 μg of the sample was separated by SDS-PAGE electrophoresis, and the protein was transferred to a nitrocellulose membrane. After blocking with 5% BSA solution at room temperature for 1 hour, the primary antibody was added and incubated at 4°C overnight, followed by the addition of horseradish peroxidase-labeled secondary antibody and incubation at room temperature for 1 hour. Finally, the membrane was imaged using SuperSignal® West Pico chemiluminescent substrate (Thermo Fisher Scientific) in the ChemiDoc XRS+ system (Bio-rad, CA, USA), and the relative quantification of protein bands was analyzed using Image-J software.

[0068] 2.6 Hematoxylin and eosin staining (HE)

[0069] The liver and kidney were quickly isolated after the mice were killed and fixed in 4% paraformaldehyde at 4°C overnight, followed by dehydration, paraffin embedding and sectioning. After a series of hydration treatments, the tissue sections were stained with hematoxylin and eosin, and images were captured using an Olympus BX51 optical microscope (Olympus, Japan).

[0070] 2.7 Statistical analysis

[0071] All data were expressed as Mean ± SEM (mean ± standard error), and the differences among the groups were analyzed using one-way ANOVA in GraphPad Prism (GraphPad Software 7.0, San Diego, USA). The differences among the groups were considered statistically significant when P < 0.05.

[0072] Example 3: Experimental results and analysis

[0073] 3.1 Chinese herbal medicine composition improves learning and memory impairment in 5XFAD dementia mice

[0074] In order to study the effect of the Chinese medicine formula (CMF) of the present invention on AD, according to the dosing regimen of 2.1 in Example 2, 3-month-old male 5XFAD mice were gavaged with double distilled water (control group), or low-dose CMF (low-dose group), or high-dose CMF (high-dose group), once a day for 3 months or 5 months, and 2 groups of blank controls were set up: 3-month-old male wild-type mice (normal group) without any treatment and 5XFAD transgenic mice (model group). After 3 or 5 months of gavage treatment, the MWM test was used to evaluate the learning and memory ability of mice in different groups.

[0075] The experimental results showed that compared with the normal group mice, the escape latency of the 6-month-old model group mice was significantly increased, while the time and distance spent in the target quadrant were significantly reduced. After 3 months of intragastric administration of CMF, the escape latency of the high-dose treatment group mice was significantly reduced compared with the control group (see Figure 1 ), while the time and distance spent in the fourth quadrant increased significantly (see Figure 2 Compared with the control group, the escape latency of mice in the low-dose treatment group was not significantly reduced (see Figure 1 ), but the time and distance spent in the fourth quadrant increased significantly (see Figure 2 ).

[0076] Similarly, the escape latency of the 8-month-old model group mice was significantly longer than that of the normal group mice, while the time they stayed in the target quadrant was significantly reduced. After 5 months of intragastric administration of CMF, the escape latency of the high-dose treatment group mice was significantly reduced compared with the control group, while the time they stayed in the fourth quadrant was significantly increased (see Figure 4 ).

[0077] The above results indicate that high-dose CMF treatment can significantly improve the spatial learning and memory impairments in 5XFAD dementia mice.

[0078] 3.2 CMF alleviates 5XFAD mice Dentate gyrus of hippocampus Deposition of amyloid plaques

[0079] Because the AD-like phenotype of 5XFAD transgenic mice is mainly due to the abnormal accumulation of amyloid plaques in the brain tissue, this example also detects the deposition of amyloid plaques in the brain tissue of different groups of mice by immunohistochemistry to explore the effect of CMF of the present invention on the pathological changes of AD.

[0080] The results showed that oral administration of low-dose or high-dose CMF for 3 or 5 months could significantly reduce the deposition of amyloid plaques in the dentate gyrus (DG) of the hippocampus of 5XFAD dementia mice (see Figure 5 and Figure 6 ).

[0081] 3.3 CMF inhibits the production of β-amyloid protein

[0082] The amyloid plaques deposited in AD brain tissue are mainly composed of abnormal aggregation of amyloid-β (Aβ), which is a polypeptide produced by the proteolysis of amyloid precursor protein (APP) by β-secretase (BACE1) and γ-secretase (PSEN1). APP is a single transmembrane protein expressed at high levels in neurons, and the Aβ fragment is located in its transmembrane region. APP can be cleaved by β-secretase at the β site to generate β-N-terminal fragment (sAPPβ) and β-C-terminal fragment. The latter is further cleaved by γ-secretase to release neurotoxic Aβ peptides and intracellular C-terminal fragments (C99). This process is called the amyloid degradation pathway of APP. The non-amyloid degradation pathway of APP is mediated by the sequential proteolysis of α-secretase (ADAM10) and γ-secretase (PSEN1), which ultimately generates non-neurotoxic α-N-terminal fragments (sAPPα) and intracellular C-terminal fragments (C83). Because the action site of α-secretase is located exactly in the Aβ region, the non-amyloidogenic degradation pathway of APP can prevent the production of Aβ.

[0083] In order to further study whether the effect of CMF in reducing amyloid plaque deposition is related to its inhibition of Aβ generation, this example detected the expression levels of APP degradation pathway-related proteins in the hippocampus tissue of mice in each experimental group after 5 months of oral administration of CMF by protein immunoblotting.

[0084] The experimental results confirmed that high-dose CMF can significantly inhibit the expression level of APP on the one hand, and significantly increase the expression levels of ADAM10 and C83 on the other hand (see Figure 7 ), indicating that the CMF of the present invention can not only inhibit the generation of Aβ by directly inhibiting the expression of Aβ precursor-APP, but also prevent the generation of Aβ by promoting the non-amyloid degradation pathway of APP, thus significantly reducing the deposition of amyloid plaques.

[0085] 3.4 CMF has no obvious toxic side effects

[0086] In order to detect whether long-term administration of CMF of the present invention will cause liver and kidney toxicity, this example uses HE staining technology to detect the changes in the tissue morphology and structure of the liver and kidney of mice in each experimental group after 5 months of oral administration of CMF.

[0087] The results showed that there was no significant difference in the histological structure of liver and kidney in CMF-treated mice compared with the control group: liver sections showed complete hepatocytes and hepatic lobule morphology, kidney sections showed normal glomerular and tubular structure, and there was no difference in inflammatory cell infiltration and cell loss among the groups (see Figure 8 ).

[0088] In addition, long-term administration of the CMF of the present invention has no significant effect on the body weight of mice (see Fig. 9 ).

[0089] The above results indicate that the metabolic process of the CMF of the present invention in 5XFAD mice neither induces liver and kidney toxicity nor causes weight loss in mice, and therefore is a safe treatment method.

Claims

1. A Chinese medicine composition for preventing and treating Alzheimer's disease, comprising: a Chinese medicine mixture consisting of concentrated powders of ginseng, polygala, calamus, tuckahoe, yam, polygonatum, green tea element and quercetin in a weight ratio of 1:1:1:1:1:1:1:1, and 10 mg of black pepper powder added to 6 g of the Chinese medicine mixture.

2. Use of the Chinese medicine composition according to claim 1 in the preparation of a medicament for treating or preventing Alzheimer's disease.

3. The use according to claim 2, wherein: The medicine is in the form of decoction, granules, powder, capsule, tablet, mixture or oral liquid.

4. The method for preparing the Chinese medicine composition according to claim 1, comprising the following steps: (1) Weigh and mix concentrated powders of ginseng, polygala root, calamus tatarinowii, poria cocos, yam, polygonatum sibiricum, green tea extract, and quercetin in a weight ratio of 1:1:1:1:1:1:1:1; (2) With respect to 6 g of the Chinese medicine mixture obtained in step (1), 10 mg of black pepper powder was added thereto, and then purified water was added to dissolve it.

5. The preparation method according to claim 4, wherein In step (2), the amount of pure water added is 150-300 ml relative to 100 g of the Chinese medicine mixture.

6. The preparation method according to claim 5, wherein: The amount of pure water added is 180-220 ml.

7. The preparation method according to any one of claims 4 to 6, wherein Step (2) includes adding pure water and then placing the mixture in a water bath at 50-60°C for 30 minutes to 1 hour to promote dissolution, and then storing the mixture in a refrigerator at 0-5°C.

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