Traditional Chinese medicine composition for preventing and treating Alzheimer disease-derived mild cognitive impairment and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition for preventing and treating Alzheimer disease-derived mild cognitive impairment and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials in parts by mass: 1 to 6 parts of American ginseng, 9 to 27 parts of rhizoma polygonati, 5 to 25 parts of fructus alpiniae oxyphyllae, 6 to 18 parts of poria cocos, 6 to 18 parts of rhizoma gastrodiae, 5 to 25 parts of pericarpium citri reticulatae, 5 to 25 parts of semen ziziphi spinosae and 6 to 18 parts of bulbus lilii. On the basis of the theory of traditional Chinese medicine, the composition is rigorous, and the compatibility relation of monarch, minister, assistant and guide is clear; rhizoma polygonati and fructus alpiniae oxyphyllae are used as ministerial drugs; gastrodia elata and lily are used as adjuvant drugs; the poria cocos and the pericarpium citri reticulatae are used as conductant drugs; the traditional Chinese medicine composition can improve Alzheimer disease-derived mild cognitive impairment, improve attention, enhance delayed memory, improve sleep quality and stabilize emotion.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for preventing and treating mild cognitive impairment caused by Alzheimer's disease and its preparation method. Background Technology

[0002] Alzheimer's-related mild cognitive impairment (AD-MCI), as a key transitional stage in the continuous spectrum of Alzheimer's disease (AD), has become a major public health challenge facing aging societies worldwide. It profoundly affects patients' cognitive function and daily living abilities, while the increasing costs of home care, the strain on professional medical resources, and the need for long-term care all pose severe challenges to society.6 Epidemiological surveys show that the prevalence of MCI in people aged 60 and above in China is approximately 15.5%, or about 38.77 million people, and about 5%-10% of MCI patients progress to dementia each year. Because AD-MCI has a high probability of progressing to AD dementia, it represents a crucial "window of opportunity" for early intervention. Clinically, AD-MCI mainly manifests in three categories of symptoms: cognitive decline, complex instrumental mild impairment of daily living abilities, and non-cognitive neuropsychiatric symptoms (NPS). Cognitive decline is the core characteristic of AD-MCI. Patients mainly exhibit a decline in their ability to learn new knowledge, recent memory loss, frequent amnesia, repetitive questioning or repetitive statements, increased reliance on paper records, and difficulty with time orientation.

[0003] It is a widely accepted consensus in the academic community to actively intervene in MCI to slow the further deterioration of cognitive impairment. However, there is currently no consensus on which drugs or methods are effective for intervention. Related research remains largely at the experimental intervention stage and has not yet formed standardized protocols. Many drugs are used to treat MCI, commonly including cholinesterase inhibitors; in addition, there are estrogen preparations, vitamin E, nonsteroidal anti-inflammatory drugs (NSAIDs), and ginkgo preparations. However, in completed randomized controlled trials, no drug has been found to effectively treat MCI or prevent its transformation into Alzheimer's disease (AD). Furthermore, most of these drugs are chemically synthesized drugs with significant toxic side effects, posing a considerable drug-induced health risk to older MCI patients. At the same time, the extremely high cost of these medications places an unbearable financial burden on patients and their families.

[0004] Therefore, from the perspective of traditional Chinese medicine, early diagnosis, intervention and treatment of MCI can delay its progression to AD, block the process of cognitive impairment, thereby improving the quality of life of patients and reducing the burden on families and society, which is of great significance. Summary of the Invention

[0005] In view of the above-mentioned technical problems, the present invention provides a traditional Chinese medicine composition for preventing and treating mild cognitive impairment caused by Alzheimer's disease and its preparation method.

[0006] The present invention adopts the following technical solution.

[0007] A traditional Chinese medicine composition for preventing and treating mild cognitive impairment caused by Alzheimer's disease comprises the following parts by weight of traditional Chinese medicinal materials: American ginseng 1-6 parts, Polygonatum sibiricum 9-27 parts, Alpinia oxyphylla 5-25 parts, Poria cocos 6-18 parts, Gastrodia elata 6-18 parts, Citrus reticulata peel 5-25 parts, Ziziphus jujuba var. spinosa 5-25 parts, and Lilium brownii 6-18 parts.

[0008] A traditional Chinese medicine composition for preventing and treating mild cognitive impairment caused by Alzheimer's disease, preferably comprising the following parts by weight of traditional Chinese medicinal materials: 3 parts American ginseng, 15 parts Polygonatum sibiricum, 15 parts Alpinia oxyphylla, 10 parts Poria cocos, 10 parts Gastrodia elata, 10 parts Citrus reticulata peel, 10 parts Ziziphus jujuba var. spinosa, and 10 parts Lilium brownii.

[0009] A traditional Chinese medicine composition for preventing and treating mild cognitive impairment caused by Alzheimer's disease, preferably comprising the following parts by weight of traditional Chinese medicinal materials: 6 parts of American ginseng, 10 parts of Polygonatum sibiricum, 25 parts of Alpinia oxyphylla, 8 parts of Poria cocos, 12 parts of Gastrodia elata, 5 parts of Citrus reticulata peel, 15 parts of Ziziphus jujuba var. spinosa, and 10 parts of Lilium brownii.

[0010] A traditional Chinese medicine composition for preventing and treating mild cognitive impairment caused by Alzheimer's disease, preferably comprising the following parts by weight of traditional Chinese medicinal materials: 5 parts American ginseng, 21 parts Polygonatum sibiricum, 20 parts Alpinia oxyphylla, 12 parts Poria cocos, 7 parts Gastrodia elata, 6 parts Citrus reticulata peel, 5 parts Ziziphus jujuba var. spinosa, and 15 parts Lilium brownii.

[0011] A method for preparing granules of a traditional Chinese medicine composition for preventing and treating mild cognitive impairment caused by Alzheimer's disease includes the following steps: The above eight traditional Chinese medicinal materials are decocted three times with water, each time adding water at a mass equal to eight times the total weight of the medicinal materials. The decoctions are decocted for 1 hour each time, the decoctions are combined, filtered, and the filtrate is concentrated to a relative density of 1.15–1.25 (50°C). An appropriate amount of soluble starch is added, and the mixture is granulated, dried, and packaged to obtain the granules.

[0012] A method for preparing a traditional Chinese medicine composition for preventing and treating mild cognitive impairment caused by Alzheimer's disease includes the following steps: The above eight traditional Chinese medicinal materials are decocted three times with water, each time adding water at a mass of 8 times the total amount of the medicinal materials. The decoction is carried out for 1.0 hour, filtered, the filtrates are combined, concentrated, packaged, and sterilized at 115℃ for 30 minutes to obtain the compound.

[0013] The main effects of the various Chinese medicinal materials used in this invention are as follows.

[0014] American ginseng is the principal herb, invigorating qi and nourishing yin, replenishing the qi of the five internal organs, especially benefiting the clear qi of the upper jiao, nourishing the empty brain marrow, clearing heat and generating fluids, preventing deficiency fire from rising and disturbing the mind. Its water extract can improve learning and memory impairment in aging mice, and the mechanism of action may be to enhance neural synaptic plasticity. Ziziphus jujuba seed is also the principal herb, possessing the functions of nourishing blood and calming the mind, replenishing liver blood to nourish the soul, and nourishing heart blood to stabilize the will. Total flavonoids and total saponins of ziziphus jujuba seed can regulate neurotransmitter levels and regulate mitochondrial rhythms to exert anti-insomnia effects. Ziziphus jujuba seed saponin A can activate the PI3K / Akt signaling pathway to regulate related proteins, reduce hippocampal neuronal apoptosis levels, alleviate hippocampal neuronal damage, and improve cognitive impairment.

[0015] Polygonatum and Alpinia oxyphylla are used as assistant herbs. Polygonatum nourishes kidney yin to replenish brain marrow, treating the root cause of memory decline, and assists American ginseng in nourishing the middle jiao, generating qi and blood to nourish the brain. Alpinia oxyphylla warms the kidneys and awakens the brain, with its pungent and aromatic properties opening the orifices. The effective parts of Polygonatum can improve the learning and memory abilities, antioxidant levels, and repair cholinergic damage in Alzheimer's mice. Alpinia oxyphylla can inhibit the expression of inflammatory factors in LPS-induced BV2 cells, protecting against LPS-induced BV2 cell damage. Its volatile oil may synergistically treat Alzheimer's disease by regulating calcium balance, cholinergic balance, and phosphorylation.

[0016] Gastrodia elata and lily bulb are used as adjuvant herbs. Gastrodia elata has the effect of calming the liver and extinguishing wind, relieving somatic symptoms of anxiety, clearing the meridians and relieving dizziness, unblocking the brain meridians, and helping tonifying herbs reach the clear orifices. Lily bulb clears the heart and relieves irritability: it drains deficiency fire and prevents disturbance of the mind, treating restlessness associated with anxiety. Gastrodin, the active ingredient in Gastrodia elata, can improve cognitive impairment in AD rats by activating the cAMP / PKA / CREB pathway, and can also improve learning and memory dysfunction in 5×FAD mice, and improve Aβ deposition in the brain of mice. Lily family increases the content of neurotransmitters in the brain of depressed mice by regulating the γ-aminobutyric acid pathway, serotonin pathway, G protein-coupled receptor pathway, and monoamine oxidase pathway, thus exerting anti-anxiety and antidepressant effects.

[0017] Poria cocos, acting as a guiding herb, strengthens the spleen and calms the mind, directing other herbs to the heart meridian, enhancing the calming effect of Ziziphus jujuba seed, preventing the generation of phlegm, and preventing phlegm from obstructing the orifices and aggravating cognitive impairment. Poria cocos polysaccharides, by downregulating the RhoA / ROCK2 signaling pathway, reduce inflammatory responses, oxidative stress, and apoptosis, thus protecting against cerebral ischemia-reperfusion injury in rats. Tangerine peel has the functions of regulating qi and resolving phlegm, invigorating the spleen and stomach, relieving qi stagnation and phlegm accumulation, preventing the cloying nature of Polygonatum sibiricum from hindering stomach absorption, ensuring the absorption of tonics, and achieving the goal of "when the spleen and stomach are healthy, the nine orifices are open." Its active ingredient, norihesperidin, can regulate oxidative stress and the expression of inflammatory factors, improving cognitive and learning memory impairment in rats anesthetized with sufentanil.

[0018] Compared with the prior art, the beneficial effects of the present invention are as follows.

[0019] This invention is based on traditional Chinese medicine theory, with a rigorous formulation and a clear relationship between the principal, assistant, adjuvant, and guide herbs: American ginseng and jujube seed are the principal herbs; polygonatum and alpinia oxyphylla are the assistant herbs; gastrodia and lily bulb are the adjuvant herbs; and poria and tangerine peel are the guiding herbs. It can improve mild cognitive impairment caused by Alzheimer's disease, enhance attention, improve delayed memory, improve sleep quality, and stabilize mood. Detailed Implementation

[0020] The present invention is further described below through specific embodiments, but the present invention is not limited to the following embodiments. Modifications, combinations, or substitutions made to the present invention within the scope of the present invention or without departing from the content, spirit, and scope of the present invention will be obvious to those skilled in the art and are included within the scope of the present invention.

[0021] A traditional Chinese medicine composition for preventing and treating mild cognitive impairment caused by Alzheimer's disease comprises the following parts by weight of traditional Chinese medicinal materials: American ginseng 1-6 parts, Polygonatum sibiricum 9-27 parts, Alpinia oxyphylla 5-25 parts, Poria cocos 6-18 parts, Gastrodia elata 6-18 parts, Citrus reticulata peel 5-25 parts, Ziziphus jujuba var. spinosa 5-25 parts, and Lilium brownii 6-18 parts.

[0022] A method for preparing granules of a traditional Chinese medicine composition for preventing and treating mild cognitive impairment caused by Alzheimer's disease includes the following steps: The above eight traditional Chinese medicinal materials are decocted three times with water, each time adding water at a rate of 8 times the total weight of the medicinal materials. The decoctions are decocted for 1 hour each time, the decoctions are combined, filtered, and the filtrate is concentrated to a relative density of 1.15–1.25 (50°C). An appropriate amount of soluble starch is added, and the mixture is granulated, dried, and packaged in 1000g portions to obtain the granules.

[0023] A method for preparing a traditional Chinese medicine compound for preventing and treating mild cognitive impairment caused by Alzheimer's disease includes the following steps: The above eight traditional Chinese medicinal materials are decocted three times with water, each time adding water at a mass of 8 times the total amount of the medicinal materials. The decoction is decocted for 1.0 hour, filtered, and the filtrates are combined, concentrated to 1000 mL, dispensed, and sterilized at 115℃ for 30 min to obtain the compound.

[0024] Example 1.

[0025] A method for preparing a traditional Chinese medicine compound for preventing and treating mild cognitive impairment caused by Alzheimer's disease includes the following steps: 3g of American ginseng, 15g of Polygonatum sibiricum, 15g of Alpinia oxyphylla, 10g of Poria cocos, 10g of Gastrodia elata, 10g of Citrus reticulata peel, 10g of Ziziphus jujuba var. spinosa, and 10g of Lilium brownii are decocted three times with water, each time adding water at a ratio of 8 times the total weight of the medicinal materials. The decoction is 1.0 hour, filtered, and the filtrates are combined, concentrated to 1000mL, dispensed, and sterilized at 115℃ for 30 minutes to obtain the compound.

[0026] Example 2.

[0027] 1. Subjects

[0028] 1.1 Diagnostic criteria

[0029] Referring to the 2024 Chinese Expert Consensus on the Diagnosis and Treatment of Mild Cognitive Impairment of Alzheimer's Disease:

[0030] ① Subjective or objective memory impairment; ② Objective manifestations of memory decline: delayed recall score on the Auditory-Verbal Learning Test is less than 1.5 standard deviations below the age- and education-matched control; ③ Montreal Cognitive Assessment (MoCA) score of 18-25; ④ Clinical Dementia Rating Scale (CDR) score of 0.5; ⑤ Minimal or no impairment in activities of daily living; ⑥ No dementia or does not meet the criteria of NINCDS-ADRD (National Institute of Neurology, Language and Communication Disorders and Stroke - Alzheimer's Disease and Related Disorders) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders - IV). ⑦ Non-cognitive neuropsychiatric symptoms (NPS): apathy, depression, anxiety, and nocturnal sleep behavior abnormalities.

[0031] 1.2 Inclusion Criteria

[0032] (1) Patients who meet the Western medical diagnostic criteria for mild cognitive impairment;

[0033] (2) Age 45-65 years old;

[0034] (3) Have received primary school education or above, possess sufficient visual and auditory discrimination abilities to undergo neuropsychological assessment, and be able to complete relevant cognitive tests and other rating scales;

[0035] (4) Able to provide contact information to cooperate with visitors and follow-ups;

[0036] (5) Those who voluntarily participate in clinical observation and sign informed consent forms.

[0037] 1.3 Exclusion Criteria

[0038] (1) Major depressive disorder, with a Hamilton Depression Rating Scale (HAMD) score ≥24;

[0039] (2) Exclude cognitive impairment caused by vascular, traumatic, or iatrogenic factors.

[0040] (3) Mental illness or congenital intellectual disability;

[0041] (4) Systemic diseases, such as thyroid dysfunction, severe liver and kidney dysfunction, hematological diseases, sick sinus syndrome, syphilis and HIV;

[0042] (5) Patients with communication and interaction barriers that affect the evaluation of cognitive function, such as severe impairments in speech, vision, and hearing;

[0043] (6) Patients with a history of drug abuse or alcoholism, or who have been using drugs that affect cognitive function, such as glucocorticoids, antipsychotics, sedatives and hypnotics, for a long time.

[0044] (7) People with allergies or who are allergic to traditional Chinese medicine.

[0045] 1.4 Shedding Criteria

[0046] (1) Those who develop certain comorbidities, complications or special physiological changes during the research process and are no longer suitable to continue participating in the research;

[0047] (2) Patients who are unwilling to continue participating in the clinical study for personal reasons;

[0048] (3) Those who cannot follow the doctor's orders for treatment, fail to take medication as required, or fail to cooperate with examinations.

[0049] 2.1 Experimental Grouping

[0050] 2.1 Subjects adopted a self-controlled pre- and post-treatment regimen.

[0051] 3.2 Tasting Method

[0052] The trial group took the traditional Chinese medicine prescription from Example 1, 100 mL each time, twice a day, morning and evening, for 30 days.

[0053] 3.3 Observation Indicators

[0054] Each indicator was measured once before and once at the end of the food trial.

[0055] 3.3.1 Improvement of symptoms in each item of the Montreal Cognitive Assessment (MoCA)

[0056] The Montreal Cognitive Assessment (MoCA) assesses various symptoms including visuospatial and executive functions, naming, attention, phonology, abstract thinking, and orientation. Scoring criteria: 26-30 points: normal; 18-25 points: mild cognitive impairment; 10-17 points: moderate cognitive impairment; <10 points: severe cognitive impairment.

[0057] 3.3.2 The Mini-Mental State Examination (MMSE) scoring system includes: spatial and temporal orientation, calculation ability, recall, naming, visuospatial ability, executive function, and reading. Scoring criteria: 27-30 points: normal; 21-26 points: mild dementia; 10-20 points: moderate dementia; ≤9 points: severe dementia.

[0058] 3.3.3 The Hamilton Depression Rating Scale (HAMD) score includes: depressed mood, guilt, suicidal ideation, difficulty falling asleep, shallow sleep, early awakening, work and interest, retardation, agitation, psychotic anxiety, somatic anxiety, gastrointestinal symptoms, general symptoms, sexual symptoms, weight loss, and insight. Scoring criteria: 0-7 points: no depression; 8-16 points: mild depression; 17-23 points: moderate depression; ≥24 points: severe depression.

[0059] 3.3.4 The Hamilton Anxiety Rating Scale (HAMA) score includes: anxious mood, tension, fear, insomnia, cognitive function, muscular system symptoms, sensory system symptoms, cardiovascular system symptoms, respiratory system symptoms, gastrointestinal symptoms, urinary system symptoms, autonomic nervous system symptoms, and behavioral performance during the interview. Scoring criteria: ≤7 points: no anxiety; 8-14 points: possible anxiety; 15-21 points: definite anxiety; 22-29 points: significant anxiety; >29 points: severe anxiety.

[0060] 3.3.5 The Pittsburgh Sleep Quality Index (PSQI) score includes: sleep onset time, sleep duration, and sleep efficiency. Scoring criteria: 0-5 points: very good sleep quality; 6-10 points: fair sleep quality; 11-15 points: average sleep quality; 16-21 points: poor sleep quality.

[0061] 3.4 Efficacy Criteria

[0062] Efficacy criteria were established based on relevant content in the "Diagnostic, Differentiation, and Efficacy Evaluation Criteria for Vascular Dementia (Research Use)". Marked effect: MoCA score improved by 20%, with significant improvement in clinical symptoms; Effective: MoCA score improved by 12% but less than 20%, with improvement in clinical symptoms; Ineffective: Did not meet the criteria for marked effect or effective. Total effective rate = (Number of markedly effective cases + Number of effective cases) / Total number of cases × 100%.

[0063] 3.4 Data Processing and Result Determination

[0064] Data analysis was performed using SPSS 23.0 statistical software. The MoCA scale, MMSE score, HAMA score, HAMD score, and PSQI score before and after the trial were all analyzed using a single t-test. p < 0.05 was considered statistically significant.

[0065] 4 Results

[0066] 4.1 Improvement of symptoms in each item of the MoCA scale

[0067] As shown in Table 1, after 30 days of drinking the herbal composition of Example 1 of this invention, the scores of all indicators on the MoCA scale were higher than before the trial (statistical data are mean ± standard deviation). Efficacy evaluation: Comparison of the total MoCA scores before and after the trial showed that 29 cases were effective and 2 cases were ineffective, with a total effective rate of 93.54%. This indicates that the overall cognitive level of patients improved after taking this invention, verifying that this invention has the effect of improving mild cognitive impairment.

[0068] Table 1. Improvement of symptoms on the MoCA scale before and after the trial.

[0069]

[0070] Note: Compared with before the food tasting, #p < 0.05.

[0071] 4.3 As shown in Table 2, after 30 days of consuming the herbal composition of Example 1 of this invention, according to the Brief Mental State Examination (MMSE) scores, the overall intelligence level of the subjects (spatial and temporal orientation, calculation ability, recall, naming, visuospatial ability, executive function, and reading) was higher than before the trial. According to the Hamilton Anxiety Rating Scale (HAMA) scores, the subjects' anxiety symptoms (anxious mood, tension, fear, insomnia, cognitive function, muscular system symptoms, sensory system symptoms, cardiovascular system symptoms, respiratory system symptoms, gastrointestinal symptoms, urinary system symptoms, etc.) were significantly improved. Symptoms of the autonomic nervous system and behavioral changes during interviews were alleviated compared to before the trial. According to the Hamilton Depression Rating Scale (HAMD) score, the subjects' inhibitory symptoms (depressive mood, guilt, suicidal ideation, difficulty falling asleep, shallow sleep, early awakening, work and interest, sluggishness, agitation, psychogenic anxiety, somatic anxiety, gastrointestinal symptoms, general symptoms, sexual symptoms, weight loss, and insight) were alleviated compared to before the trial. According to the Pittsburgh Sleep Quality Index (PSQI) score, the subjects' sleep quality (sleep onset time, sleep duration, and sleep efficiency) was significantly improved compared to before the trial. This indicates that the pharmaceutical composition of this invention not only improves cognitive function but also significantly enhances the subjects' intelligence, mental state, and sleep quality, demonstrating that the body undergoes overall adjustment after taking the pharmaceutical composition of this invention.

[0072] Table 2 shows the improvement in intelligence, mental state, and sleep quality after the trial.

[0073]

[0074] Note: Compared with before the taste test # p < 0.05.

[0075] Example 3.

[0076] Typical case.

[0077] Case 1.

[0078] Mr. Wang, male, 72 years old, retired worker.

[0079] Symptoms: The patient is elderly and usually suffers from dizziness, tinnitus, fatigue, weakness in the lower back and knees, memory loss, especially short-term memory, poor concentration, mental distraction, inability to fully recount recent events, apathy, obesity, and frequent and easy awakenings.

[0080] Diagnosis: Mild cognitive impairment.

[0081] Application: Administer the traditional Chinese medicine prescription, 2 doses per day, 100mL each, taken half an hour after breakfast and dinner, for 30 days as one course of treatment.

[0082] Therapeutic effects: After one month of use, patients reported improved memory, better mental state, no fatigue, improved attention, and the ability to concentrate on reading books and newspapers. Their ability to retell events also improved, and they could clearly retell what had just happened. They had deep sleep, were not easily awakened, and their physical strength was restored.

[0083] Case 2.

[0084] Ms. Zhang, 48 years old, currently employed.

[0085] Symptoms: The patient usually suffers from insomnia and vivid dreams due to high work pressure, emotional instability, irritability and restlessness. For the past two months, the patient has experienced memory loss, forgetfulness of recent events, reduced fluency of speech, and occasional incoherent speech, which can be corrected by the patient after being discovered. The patient also has poor concentration, decreased executive function, and poor appetite.

[0086] Diagnosis: Mild cognitive impairment.

[0087] Application: Administer the traditional Chinese medicine prescription, 2 doses per day, 100mL each, taken half an hour after breakfast and dinner, for 30 days as one course of treatment.

[0088] Therapeutic effects: After one month of use, patients reported improved memory, especially short-term memory, stable emotions, less irritability, good appetite, fluent speech with no mispronunciations, improved attention, increased work efficiency, high execution, and good sleep quality, sleeping 7-8 hours per night.

[0089] Case 3.

[0090] Mr. Tang, male, 80 years old, retired.

[0091] Symptoms: For the past six months, the patient has experienced poor appetite, weight loss, fatigue, drowsiness, weakness, memory decline, forgetting both recent and distant events, decreased spatial and temporal orientation, inability to read clocks, and inability to state months, days of the week, seasons, cities, or locations. The patient also has difficulty understanding abstract concepts, poor logical thinking in speech, decreased fluency, poor calculation ability, inability to read text, and inability to name objects.

[0092] Diagnosis: Mild cognitive impairment.

[0093] Application: Administer the traditional Chinese medicine prescription, 2 doses per day, 100mL each, taken half an hour after breakfast and dinner, for 30 days as one course of treatment.

[0094] Therapeutic effects: After 2 months of use, patients' memory improved, especially their recent memory. Their orientation improved, and they could tell time, read books and newspapers, and say the season, month, and place. Their language had a certain degree of logic, and they could express their needs. Their fluency improved, their calculation ability improved, and they could perform simple calculations. Their appetite improved, and they could eat on their own. Their mental state was also good.

Claims

1. A traditional Chinese medicine composition for preventing and treating mild cognitive impairment caused by Alzheimer's disease, characterized in that, The following Chinese medicinal materials are included in the following proportions by weight: American ginseng 1-6 parts, Polygonatum sibiricum 9-27 parts, Alpinia oxyphylla 5-25 parts, Poria cocos 6-18 parts, Gastrodia elata 6-18 parts, Citrus reticulata peel 5-25 parts, Ziziphus jujuba var. spinosa 5-25 parts, and Lilium brownii 6-18 parts.

2. A traditional Chinese medicine composition for preventing and treating mild cognitive impairment caused by Alzheimer's disease, characterized in that, The following Chinese medicinal materials are included in the following proportions by weight: American ginseng 3 parts, Polygonatum sibiricum 15 parts, Alpinia oxyphylla 15 parts, Poria cocos 10 parts, Gastrodia elata 10 parts, Citrus reticulata peel 10 parts, Ziziphus jujuba var. spinosa 10 parts, and Lilium brownii 10 parts.

3. A traditional Chinese medicine composition for preventing and treating mild cognitive impairment caused by Alzheimer's disease, characterized in that, The following Chinese medicinal materials are included in the following proportions by weight: American ginseng 6 parts, Polygonatum sibiricum 10 parts, Alpinia oxyphylla 25 parts, Poria cocos 8 parts, Gastrodia elata 12 parts, Citrus reticulata peel 5 parts, Ziziphus jujuba var. spinosa 15 parts, and Lilium brownii 10 parts.

4. A traditional Chinese medicine composition for preventing and treating mild cognitive impairment caused by Alzheimer's disease, characterized in that, The following Chinese medicinal materials are included in the following proportions by weight: American ginseng 5 parts, Polygonatum sibiricum 21 parts, Alpinia oxyphylla 20 parts, Poria cocos 12 parts, Gastrodia elata 7 parts, Citrus reticulata peel 6 parts, Ziziphus jujuba var. spinosa 5 parts, and Lilium brownii 15 parts.

5. The traditional Chinese medicine composition for preventing and treating mild cognitive impairment caused by Alzheimer's disease according to any one of claims 1-4, characterized in that, The specific steps for preparing granules of the traditional Chinese medicine composition are as follows: Add water to the above eight Chinese medicinal materials and decoct three times, each time adding water at a mass of 8 times the total amount of Chinese medicinal materials, decoct for 1.0 hour, combine the decoctions, filter, concentrate the filtrate to a relative density of 1.15-1.25 at 50℃, add an appropriate amount of soluble starch, make granules, dry, and package to obtain granules.

6. The traditional Chinese medicine composition for preventing and treating mild cognitive impairment of Alzheimer's disease according to any one of claims 1-4, characterized in that, The preparation method of the traditional Chinese medicine composition is as follows: Add water to the above eight Chinese medicinal materials and decoct three times. Each time, the water mass is 8 times the total mass of the Chinese medicinal materials. Decoction for 1.0 hour, filter, combine the filtrates, concentrate, dispense, and sterilize at 115℃ for 30 minutes to obtain the compound.

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