Traditional Chinese medicine composition for treating senile dementia as well as preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition which is prepared from the following traditional Chinese medicinal raw materials in parts by weight: 1-10 parts of herba cistanche, 1-10 parts of rhizoma anemarrhenae, 1-10 parts of ginseng, 1-10 parts of radix morindae officinalis and 1-10 parts of folium ginkgo. The traditional Chinese medicine composition can be used for preventing or treating senile dementia.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating senile dementia and a preparation method and application thereof. BACKGROUND

[0002] Dementia is a clinical syndrome of progressive cognitive decline caused by brain injury or disease, which is a neurodegenerative disease in terms of memory and cognitive function. The etiology of dementia is complex, which may be related to genetic factors, and is also affected by environmental factors and induced factors, as well as more than 100 other diseases that can cause dementia. Among them, the two most common types of dementia in the elderly are Alzheimer's disease (AD) and vascular dementia (VD).

[0003] Alzheimer's disease (AD) is the most common type of dementia. According to the World Alzheimer's Disease Report, half of the global dementia patients are AD patients. The clinical manifestations of AD mainly include learning and memory impairment, cognitive impairment and language impairment, and the main neuropathological features include extracellular senile plaques formed by β-amyloid protein (Aβ) deposition and neurofibrillary tangles formed by tau protein hyperphosphorylation. The etiology of AD is still controversial, and there is a lack of specific drugs for treatment. Currently, the drugs used for treating AD mainly include acetylcholinesterase inhibitors and N-methyl-D-aspartate receptor inhibitors, but their main role is to relieve some symptoms of patients, and they cannot prevent or cure AD. In the past 10 years, new drugs targeting AB and Tau protein have failed in clinical trials one after another, and the etiology and treatment targets of AD are expected to have more innovative research.

[0004] Vascular dementia refers to a clinical syndrome caused by a series of cerebral vascular factors, which is mainly characterized by high-level neurocognitive impairment based on brain tissue damage. It is mainly secondary to ischemic cerebrovascular disease and is one of the most common types of senile dementia. In addition to the symptoms and signs of neurological system localization damage, there are also occasional neuropsychological symptoms and abnormal behavior, which seriously affect the quality of life of patients, but there is no specific drug for treating VD at present.

[0005] There is an urgent need for traditional Chinese medicine for treating senile dementia. SUMMARY

[0006] One or more embodiments of the present application provide a traditional Chinese medicine composition prepared from the following weight parts of traditional Chinese medicinal materials: 1-10 parts by weight of Cistanche, and 1-10 parts by weight of Anemarrhena asphodeloides.

[0007] In one or more embodiments, the ratio of the weight parts of Cistanche to the weight parts of Anemarrhena asphodeloides is 1:1-3, for example 1:2 or 1:1.

[0008] One or more embodiments of the present application provide a traditional Chinese medicine composition prepared from raw materials comprising the following weight parts of traditional Chinese medicinal materials: Cistanche 1-10 parts by weight, Anemarrhena asphodeloides 1-10 parts by weight.

[0009] In one or more embodiments, the ratio of the weight parts of Cistanche to the weight parts of Anemarrhena asphodeloides is 1:1-3, for example 1:2 or 1:1.

[0010] In one or more embodiments, the raw materials for preparing the pharmaceutical composition further comprise one or more of the following weight parts of medicinal materials: Panax ginseng 1-10 parts, Radix Morindae Officinalis 1-10 parts, Ginkgo leaves 1-10 parts.

[0011] One or more embodiments of the present application provide a traditional Chinese medicine composition prepared from the following weight parts of traditional Chinese medicinal materials: Cistanche 1-10 parts by weight, Anemarrhena asphodeloides 1-10 parts by weight, optionally Panax ginseng 1-10 parts, optionally Radix Morindae Officinalis 1-10 parts, and optionally Ginkgo leaves 1-10 parts.

[0012] In one or more embodiments, the traditional Chinese medicine composition is prepared by the following method:

[0013] (1) weighing the weight parts of medicinal materials in any of the above embodiments;

[0014] (2) heating the medicinal materials with water or 30-70% (e.g. 40%, 50%, 60%, 70%) ethanol by volume to extract 1 time for 40-60 min (e.g. 50 min) to obtain an extract;

[0015] (3) optionally, filtering and concentrating the extract to obtain a concentrated solution;

[0016] (4) optionally, drying and crushing the concentrated solution.

[0017] In one or more embodiments, in step (2), when the extraction is performed 1 time, 800-1000 mL of extraction solvent is used per 100 g of medicinal materials; when the extraction is performed 2 times, 800-1000 mL of extraction solvent is used per 100 g of medicinal materials; and when the extraction is performed 3 times, 800-1000 mL, 800-1000 mL, and 600-800 mL of extraction solvent is used per 100 g of medicinal materials, respectively.

[0018] In one or more embodiments, the medicinal materials are extracted 2 or 3 times for 40-60 min each time, and the extracts are combined.

[0019] In one or more embodiments, the herbal material is soaked for 20-60 min (e.g., 30 min, 40 min, 50 min) before the heating extraction.

[0020] In one or more embodiments, the drying is freeze-drying or spray-drying.

[0021] One or more embodiments of the present application provide a method for preparing the traditional Chinese medicine composition of the present application, which comprises:

[0022] (1) weighing the herbal material according to the weight parts in any of the embodiments described above;

[0023] (2) heating the herbal material with water or 30-70% (e.g., 40%, 50%, 60%, 70%) ethanol to extract for 40-60 min (e.g., 50 min) to obtain an extract;

[0024] (3) optionally, filtering and concentrating the extract to obtain a concentrated extract;

[0025] (4) optionally, drying and pulverizing the concentrated extract.

[0026] In one or more embodiments, the herbal material is extracted for 2 or 3 times, each time for 40-60 min, and the extracts are combined.

[0027] In one or more embodiments, the herbal material is soaked for 20-60 min (e.g., 30 min, 40 min, 50 min) before the heating extraction.

[0028] In one or more embodiments, the drying is freeze-drying or spray-drying.

[0029] In one or more embodiments, in step (2), when the extraction is performed for 1 time, 800-1000 mL of extraction solvent is used per 100 g of herbal material; when the extraction is performed for 2 times, 800-1000 mL of extraction solvent is used per 100 g of herbal material; and when the extraction is performed for 3 times, 800-1000 mL, 800-1000 mL, and 600-800 mL of extraction solvent is used per 100 g of herbal material, respectively.

[0030] One or more embodiments of the present application provide a traditional Chinese medicine preparation, which comprises the traditional Chinese medicine composition described in the present application and a pharmaceutically acceptable excipient or excipient.

[0031] In one or more embodiments, the traditional Chinese medicine preparation is a solution, a powder, a spray, a syrup, a suppository, a tablet, a pill, a granule, a capsule, an injection, or a gastroresistant controlled-release preparation.

[0032] One or more embodiments of the present application provide a use of the traditional Chinese medicine composition of the present application or the traditional Chinese medicine preparation of the present application in the preparation of a drug, health product or functional food for preventing or treating senile dementia.

[0033] In one or more embodiments, the senile dementia is Alzheimer's disease, vascular dementia or Lewy body dementia.

[0034] In one or more embodiments, the senile dementia is senile dementia induced or accompanied by any one of neurological disorder, neurodegenerative disease, brain trauma or cancer in the development or treatment process.

[0035] In one or more embodiments, the traditional Chinese medicine composition of the present application can be used for preventing or treating senile dementia.

[0036] In one or more embodiments, the traditional Chinese medicine preparation of the present application can be used for preventing or treating senile dementia.

[0037] In one or more embodiments, the traditional Chinese medicine composition of the present application is prepared by two medicinal ingredients of Anemarrhena asphodeloides and Cistanche, or one or more of Panax ginseng, Morinda officinalis and Ginkgo biloba is added or subtracted and formulated in a certain proportion.

[0038] In the Chinese Pharmacopoeia (2020 edition), Anemarrhena asphodeloides is bitter and sweet in nature, cold in property, and belongs to the lung, stomach and kidney channels, which has the effects of clearing heat and purging fire, nourishing yin and moistening dryness, and is used for treating exogenous febrile disease, high fever, thirst, lung heat and dry cough, bone steaming and hot, internal heat and diabetes, and dry constipation. In modern research, Anemarrhena asphodeloides has pharmacological activities such as preventing and treating Alzheimer's disease, protecting brain ischemia injury, anticoagulation, antioxidant, antitumor, antiosteoporosis, anti-inflammatory, reducing blood pressure, reducing blood sugar and reducing blood lipid. In the Chinese Pharmacopoeia (2020 edition), Cistanche is sweet and salty in nature, warm in property, and belongs to the kidney and large intestine channels, which has the effects of tonifying kidney yang, benefiting essence and blood, moistening the intestines and relieving constipation, and is used for treating kidney yang deficiency, essence and blood deficiency, impotence, cold and softness of waist and knees, weakness of muscles and bones, and dry constipation. In modern research, Cistanche has the effects of nerve protection, bone protection, anti-injury and liver protection. Panax ginseng is sweet, slightly bitter and slightly warm, and belongs to the spleen, lung, heart and kidney channels, which can tonify primordial qi, restore pulse and prevent collapse, tonify the spleen and lung, produce saliva and nourish blood, and calm the mind and improve intelligence. It is used for treating body weakness, cold limbs and weak pulse, spleen deficiency, lung deficiency, dry cough, thirst, internal heat and diabetes, deficiency of qi and blood, long-term disease, insomnia, impotence and cold palace. Morinda officinalis is sweet and pungent, and slightly warm. It belongs to the kidney and liver channels, and can tonify kidney yang, strengthen muscles and bones, and dispel wind and dampness. It is used for treating impotence, cold and infertility, irregular menstruation, cold pain in the lower abdomen, rheumatism and muscle and bone weakness. Ginkgo biloba is sweet, bitter and astringent, and neutral. It belongs to the heart and lung channels, and can activate blood and resolve stasis, dredge collaterals and relieve pain, astringe lung and relieve asthma, and reduce turbidity and lower lipid. It is used for treating blood stasis blocking collaterals, chest pain, stroke, lung deficiency and asthma, and hyperlipidemia.

[0039] Based on modern research guidance, it is found that the synergistic effect of various composition extracts is better than that of single herb medicine. The application designs a composition extract containing two (Anemarrhena asphodeloides Bunge and Cistanche deserticola Y.C.Ma) or more drugs and a preparation process, and studies the active effect of the extract in preventing and treating senile dementia.

[0040] In one or more embodiments, in step (2), when the extraction times is 1 time, 800-1000 mL of extraction solvent is used for every 100 g of medicinal materials; when the extraction times is 2 times, 800-1000 mL of extraction solvent is used for every 100 g of medicinal materials; and when the extraction times is 3 times, 800-1000 mL, 800-1000 mL and 600-800 mL of extraction solvent is used for every 100 g of medicinal materials, respectively.

[0041] Cistanche deserticola Y.C.Ma or Cistanchetubulosa (Schenk) Wight of the Orobanchaceae family.

[0042] Anemarrhena asphodeloides Bunge of the Liliaceae family.

[0043] Panax ginseng C.A.Mey. of the Araliaceae family.

[0044] Morinda officinalis How of the Rubiaceae family.

[0045] Ginkgo biloba L. of the Ginkgoaceae family.

[0046] Compared with the prior art, the application has at least one of the following beneficial effects:

[0047] (1) The application can enrich active ingredients, improve efficacy and reduce side effects on the body through certain extraction and processing;

[0048] (2) The application has better efficacy at a relatively low dose;

[0049] (3) The application can be used for preparing medicines, health products or functional foods for preventing and / or treating senile dementia, and has better effect than using single herb medicine. BRIEF DESCRIPTION OF DRAWINGS

[0050] Figure 1 is a graph showing the effect of the traditional Chinese medicine composition in Example 2 on the short-term working memory of 5xFAD mice. Figure 1 A and Figure 1B represents the percentage of alternation times of each group of mice in the Y maze after the female group of mice was given treatment for 4 weeks and 8 weeks; Figure 1 C and Figure 1 D represents the percentage of alternation times of each group of mice in the Y maze after the male group of mice was given treatment for 4 weeks and 8 weeks. The data is expressed as mean ± standard error, **P<0.01.

[0051] Figure 2 Figure for the effect of the traditional Chinese medicine composition in Example 2 on the short-term spatial reference memory of 5xFAD mice, wherein Figure 2 A and Figure 2 B represents the preference degree of each group of mice for exploring the new object in the new object recognition after the female group of mice was given treatment for 4 weeks and 8 weeks; Figure 2 C and Figure 2 D represents the preference degree of each group of mice for exploring the new object in the new object recognition after the male group of mice was given treatment for 4 weeks and 8 weeks. The data is expressed as mean ± standard error, *P<0.05, **P<0.01, ***P<0.001.

[0052] Figure 3 Figure for the effect of the two traditional Chinese medicine compound test substances in Example 5 on the short-term working memory of 5xFAD mice, wherein Figure 3 A and Figure 3 B represents the percentage of alternation times of each group of mice in the Y maze after the female group of mice was given treatment for 4 weeks and 8 weeks; Figure 3 C and Figure 3 D represents the percentage of alternation times of each group of mice in the Y maze after the male group of mice was given treatment for 4 weeks and 8 weeks. The data is expressed as mean ± standard error, *P<0.05, **P<0.01.

[0053] Figure 4 Figure for the effect of the two traditional Chinese medicine compound test substances in Example 5 on the short-term spatial reference memory of 5xFAD mice, wherein Figure 4 A and Figure 4 B represents the preference degree of each group of mice for exploring the new object in the new object recognition after the female group of mice was given treatment for 4 weeks and 8 weeks; Figure 4 C and Figure 4 D represents the preference degree of each group of mice for exploring the new object in the new object recognition after the male group of mice was given treatment for 4 weeks and 8 weeks. The data is expressed as mean ± standard error, *P<0.05, **P<0.01, ***P<0.001. DETAILED DESCRIPTION

[0054] Example 1

[0055] The present embodiment provides a preparation method of a pharmaceutical composition extract prepared from Anemarrhena asphodeloides and Cistanche, comprising the following steps:

[0056] (1) Weighing: Cistanche and Anemarrhena aspera were weighed in a weight ratio of 1:1 and put into the extraction device;

[0057] (2) Extraction: 50% ethanol was added for 30 min, heating was started, and extraction was performed three times;

[0058] (3) Filtration: the extraction liquid was filtered, and the mixed extraction liquid was obtained;

[0059] (4) Concentration: the filtrate was vacuum rotary concentrated, and the mixed concentrated liquid was obtained;

[0060] (5) Drying: the concentrated liquid was dried.

[0061] Example 2

[0062] This example verifies the effect of the traditional Chinese medicine extract prepared in Example 1 on a mouse learning and memory disorder model:

[0063] 2.1 Experimental animals

[0064] The experimental animals used in this study mainly include 5xFAD mice and littermate negative controls. When the mice reached 6 months of age, they were transported to the animal center by SPF transfer cages. Then the mice were divided into six groups, including the control group (WT), the model group (0), the low-dose group (L), the medium-dose group (M), the high-dose group (H), the Cistanche group (R), the Anemarrhena aspera group (Z), and the positive drug group (Mem). Each group had female and male subgroups. The experimental mice were subsequently bred and drug-treated in the SPF animal room, which had a temperature of 21±2℃, a relative humidity of 55±5%, and a 12-hour day / night cycle.

[0065] 2.2 Drug preparation and treatment

[0066] The test drug (the traditional Chinese medicine composition extract prepared in Example 1) was divided into low (0.424 g / kg), medium (1.272 g / kg), and high (3.815 g / kg) doses. The dosages of Cistanche extract and Anemarrhena aspera extract were both 0.636 g / kg. The positive drug was treated with memantine (20 mg / kg / d). The mice treated with the two drugs were treated for a total of 8 weeks, once a day, and the drugs were dissolved in normal saline. The control group and the model group were given the corresponding volume of normal saline. The administration method was oral gavage.

[0067] 2.3 Main experimental methods

[0068] All behavioral tests were performed in the behavior room, starting at 8 am every day. The mice were transferred to the designated room 2 hours before the experiment. Short-term memory was tested using the novel object recognition (NOR) and Y maze; long-term memory was tested using the water maze.

[0069] 2.3.1 Y maze

[0070] Y maze test is mainly used to evaluate the short-term working memory of mice. The maze is composed of three identical arms (44 x 10 x 15 cm), with an angle of 120 degrees between the arms, and the three arms are defined as A arm, B arm and C arm, respectively. During the test, the mice face the central area and are placed in the A arm, and are allowed to freely explore the maze for 8 minutes. The number of alternations of the mice in the maze is recorded, and the mice are defined as one alternation when they explore any of the following situations: ABC, BCA, CAB. The percentage of alternation number of the mice is defined as the total alternation number divided by the total number of times the mice enter the three arms minus two, and the better the memory of the mice, the higher the percentage of alternation number. After each test, the device is thoroughly cleaned with 75% ethanol.

[0071] 2.3.2 Novel object recognition

[0072] Novel object recognition is mainly used to evaluate short-term memory. In the training stage, two identical objects are placed in the upper half of the open field area on the left and right center, and the mice are placed in the middle of the lower half of the open field area with their backs to the two objects, and are allowed to freely explore for 10 minutes. 60 minutes later, one of the objects is replaced by a new object, and the mice are allowed to explore for 5 minutes. A camera tracks the head of the mouse and records the time spent by the mouse exploring the new object within 5 minutes. The exploration time of the mouse to the object is defined as the time spent by the mouse within 1.5 cm from the object, and the preference for the new object is defined as the percentage of the time spent exploring the new object to the total time spent exploring the two objects. The better the memory of the mice, the more time spent exploring the new object. After each test, the device is thoroughly cleaned with 75% ethanol.

[0073] 2.4 Statistical analysis

[0074] Statistical analysis was performed using GraphPad Prism 8.0 statistical software, and the results were expressed as mean ± standard error. Two groups were statistically compared using two-tailed unpaired Student's t test. At the same time, one-way ANOVA was used to determine the differences between groups for statistical comparison of multiple groups. If the difference between groups is significant, Bonferroni's post hoc test is used for comparison between two groups. P < 0.05 indicates that the difference is statistically significant.

[0075] 3 Research results

[0076] 3.1 Effect of traditional Chinese medicine compound (extract prepared in Example 1) on short-term working memory of 5xFAD mice

[0077] To investigate the therapeutic effect of the traditional Chinese medicine compound on AD mice, 5xFAD mice at 6 months of age were selected as the test object, and the mice were treated by gavage with the traditional Chinese medicine compound. When the treatment was performed for 4 weeks and 8 weeks, various behavioral tests including Y maze and novel object recognition were performed to investigate the efficacy of the traditional Chinese medicine compound on 5xFAD mice. Among them, the Y maze experiment was used to study the short-term working memory of mice. As shown in Figure 1 A to Figure 1 D, compared with the WT group, 5xFAD mice (model group (0), low-dose group (L), medium-dose group (M), high-dose group (H), and positive drug group (Mem)) showed obvious working memory impairment in both female and male groups. At the same time, after 4 weeks of treatment, the test drugs had no obvious effect on the working memory of female and male 5xFAD mice Figure 1 A and Figure 1 C). However, after 8 weeks of treatment, the test drugs showed obvious protective effect on the male group of mice, among which the medium-dose group showed the best effect Figure 1 D). The Cistanche extract and Anemarrhena asphodeloides extract had no obvious effect on improving working memory, and were generally worse than the compound. The above data suggest that the traditional Chinese medicine compound has an improving effect on the short-term working memory of 5xFAD mice, and the effect on the male group is better.

[0078] 3.2 Effect of Traditional Chinese Medicine Compound on Short-term Spatial Reference Memory of 5xFAD Mice

[0079] The novel object recognition experiment was used to study the effect of the traditional Chinese medicine compound on the short-term spatial reference memory of 5xFAD mice. As shown in Figure 2 A to Figure 2 D, compared with the WT group, 5xFAD mice showed obvious short-term spatial reference memory impairment in both female and male groups. After 4 weeks of treatment, there was no obvious change in female 5xFAD mice after drug intervention compared with the 5xFAD group Figure 2 A), while in male 5xFAD mice, the high-dose treatment group showed obvious memory improvement Figure 2 C). After 8 weeks of treatment, the same efficacy was found in the male group Figure 2 B and Figure 2 D). The Cistanche extract and Anemarrhena asphodeloides extract had no obvious effect on improving working memory, and were generally worse than the compound. The above results show that high-dose treatment of the traditional Chinese medicine compound can significantly improve the memory impairment of male 5xFAD mice.

[0080] Example 3

[0081] The traditional Chinese medicine composition prepared in the embodiment is prepared from the following weight parts of traditional Chinese medicinal materials: 1 part of Cistanche, 2 parts of Anemarrhena rhizome, 2 parts of Panax ginseng, and 2 parts of Morinda officinalis, and the preparation method of the extract is as follows:

[0082] (1) weighing: Cistanche, Anemarrhena rhizome, Panax ginseng and Morinda officinalis were weighed according to the weight ratio of 1:2:2:2 and put into the extraction device;

[0083] (2) extraction: water was added and soaked for 30 min, and heating was started, and extraction was performed three times, 1 h each time, with a solid-liquid ratio of 1:10, 1:8 and 1:6;

[0084] (3) filtration: the extraction liquid was filtered while hot, and the mixed extraction liquid was obtained;

[0085] (4) concentration: the filtrate was vacuum rotary concentrated, and the mixed concentrated liquid was obtained;

[0086] (5) drying: the concentrated liquid was dried.

[0087] Example 4

[0088] The traditional Chinese medicine composition prepared in the embodiment is prepared from the following weight parts of traditional Chinese medicinal materials: 1 part of Cistanche, 2 parts of Anemarrhena rhizome, 2 parts of Panax ginseng, and 2 parts of Morinda officinalis, and the preparation method of the extract is as follows:

[0089] (1) weighing: Cistanche, Anemarrhena rhizome, Panax ginseng, Morinda officinalis and Ginkgo biloba were weighed according to the weight ratio of 1:2:2:2:1 and put into the reflux extraction device;

[0090] (2) extraction: 70% ethanol was added and soaked for 30 min, and heating was started, and extraction was performed three times, 1 h each time, with a solid-liquid ratio of 1:10, 1:8 and 1:6;

[0091] (3) filtration: the extraction liquid was filtered, and the mixed extraction liquid was obtained;

[0092] (4) concentration: the filtrate was vacuum rotary concentrated, and the mixed concentrated liquid was obtained;

[0093] (5) drying: the concentrated liquid was dried.

[0094] Example 5

[0095] The embodiment verifies the influence of the traditional Chinese medicine composition extracts prepared in Examples 3 and 4 on the learning and memory disorder model of mice:

[0096] 5.1 experimental animals

[0097] The experimental animals used in this study mainly include 5xFAD mice and littermate negative controls. When the mice reach 6 months of age, they are transported to the animal center by SPF transfer cages. Then the mice are divided into six groups, including the control group (WT), the model group (0), the positive drug group (Mem), the test substance A group (A) and the test substance B group (B), and each group has female and male subgroups. The experimental mice are subsequently bred and drug treated in the SPF animal room, with a temperature of 21±2℃, a relative humidity of 55±5%, and a 12-hour day / night cycle.

[0098] 2.2 Drug preparation and treatment

[0099] The test drugs A (extract of traditional Chinese medicine composition prepared in Example 3) and B (extract of traditional Chinese medicine composition prepared in Example 4) are administered at a dose of 1.272 g / kg, while the positive drug is treated with memantine (20 mg / kg / d). The mice treated with the two drugs are administered once a day for a total of 8 weeks, and the drugs are dissolved in normal saline. The control group and the model group are given the corresponding volume of normal saline. The administration method is oral gavage.

[0100] 2.3 The main experimental methods, statistical methods and Example 2 are the same.

[0101] 3 Research results

[0102] 3.1 Effect of traditional Chinese medicine composition extract A (extract prepared in Example 3) and traditional Chinese medicine composition extract B (extract prepared in Example 4) on the short-term working memory of 5xFAD mice

[0103] This project selects 6-month-old 5xFAD mice as the test object and gives the mice traditional Chinese medicine composition extract A and traditional Chinese medicine composition extract B by gavage. When the treatment reaches the 4th week and the 8th week, various behavioral tests (including Y maze and novel object recognition) are performed to investigate the efficacy of traditional Chinese medicine composition extract A and traditional Chinese medicine composition extract B on 5xFAD mice. Among them, the Y maze experiment is used to study the short-term working memory of mice. As Figure 3 A to Figure 3 D shows that compared with the WT group, both male and female 5xFAD mice show obvious working memory impairment. After 4 weeks of administration, both the test traditional Chinese medicine composition extract A and the test traditional Chinese medicine composition extract B show a certain improvement trend in the working memory of female ( Figure 3 A) and male ( Figure 3 C) 5xFAD mice, but there is no significant difference. After 8 weeks of treatment, both the test traditional Chinese medicine composition extract A and the test traditional Chinese medicine composition extract B can significantly improve the performance of male mice in the Y maze, showing a protective effect on learning and memory ability. There is no significant difference between the protective effects of the test traditional Chinese medicine composition extract A and the test traditional Chinese medicine composition extract B ( Figure 3D). The above data suggest that the traditional Chinese medicine composition extract A and the traditional Chinese medicine composition extract B present an improving effect on the short-term working memory of 5xFAD mice.

[0104] 3.2 Effects of traditional Chinese medicine composition extract A and traditional Chinese medicine composition extract B on the short-term spatial reference memory of 5xFAD mice

[0105] The new object recognition experiment was used to study the effects of traditional Chinese medicine composition extract A and traditional Chinese medicine composition extract B on the short-term spatial reference memory of 5xFAD mice. As shown in Figure 4 A to Figure 4 D, compared with the WT group, both male and female 5xFAD mice showed obvious short-term spatial reference memory impairment. After 4 weeks of treatment, there was no significant change in female 5xFAD mice after the administration of the tested traditional Chinese medicine composition extract A and traditional Chinese medicine composition extract B compared with the 5xFAD group (0 group) ( Figure 4 A), while in male 5xFAD mice, the tested traditional Chinese medicine composition extract B group showed a significant memory improvement effect ( Figure 4 C). After 8 weeks of treatment, the same improvement was found in both male and female groups ( Figure 4 B and Figure 4 D). The above results show that high-dose traditional Chinese medicine compound treatment can significantly improve the memory impairment of male 5xFAD mice.

[0106] The above-described embodiments are only to describe the preferred modes of the present application, and do not limit the scope of the present application. Without departing from the design spirit of the present application, various modifications and improvements to the technical solutions of the present application made by those skilled in the art shall fall within the protection scope determined by the claims of the present application.

Claims

1. A traditional Chinese medicine composition, which is prepared from the following traditional Chinese medicinal materials in parts by weight: 1-10 parts by weight of Cistanche deserticola and 1-10 parts by weight of Anemarrhena asphodeloides; preferably, the ratio of the weight of Cistanche deserticola to the weight of Anemarrhena asphodeloides is 1:1-3, preferably 1:2 or 1:

1.

2. A traditional Chinese medicine composition, which is prepared from raw materials containing the following parts by weight: 1-10 parts by weight of Cistanche deserticola and 1-10 parts by weight of Anemarrhena asphodeloides; preferably, the ratio of the parts by weight of Cistanche deserticola to the parts by weight of Anemarrhena asphodeloides is 1:1-3, preferably 1:2 or 1:

1.

3. The traditional Chinese medicine composition according to claim 2, wherein the raw materials for preparing the pharmaceutical composition further comprise one or more of the following medicinal materials in parts by weight: ginseng 1-10 parts by weight, Morinda officinalis 1-10 parts by weight, and Ginkgo biloba leaves 1-10 parts by weight.

4. The traditional Chinese medicine composition according to any one of claims 1-3, wherein the traditional Chinese medicine composition is prepared by the following method: (1) Weigh the medicinal materials according to any one of claims 1-3 by weight; (2) The medicinal material is heated and extracted once for 40-60 min with water or 30-70% vol% or preferably 50-70% vol% ethanol to obtain an extract; preferably, the medicinal material is extracted 2 or 3 times, each time for 40-60 min, and the extracts are combined; preferably, the medicinal material is soaked for 20-60 min before heating and extraction, preferably for 30 min. (3) Optionally, the extract is filtered and concentrated to obtain a concentrated solution; (4) Optionally, the concentrate is dried and pulverized; preferably, the drying is freeze-drying or spray drying; Preferably, in step (2), when the extraction is performed once, 800-1000 mL of extraction solvent is used for every 100g of medicinal material; when the extraction is performed twice, 800-1000 mL of extraction solvent is used for every 100g of medicinal material; when the extraction is performed three times, 800-1000 mL, 800-1000 mL, and 600-800 mL of extraction solvent are used for every 100g of medicinal material, respectively.

5. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-4, comprising: (1) Weigh the medicinal materials according to any one of claims 1-3 by weight; (2) The medicinal material is heated and extracted once for 40-60 min with water or 30-70% vol% or preferably 50-70% vol% ethanol to obtain an extract; preferably, the medicinal material is extracted 2 or 3 times, each time for 40-60 min, and the extracts are combined; preferably, the medicinal material is soaked for 20-60 min before heating and extraction, preferably for 30 min. (3) Optionally, the extract is filtered and concentrated to obtain a concentrated solution; (4) Optionally, the concentrate is dried and pulverized; preferably, the drying is freeze drying or spray drying.

6. The preparation method according to claim 5, wherein in step (2), when the extraction is performed once, 800-1000 mL of extraction solvent is used for every 100 g of medicinal material; when the extraction is performed twice, 800-1000 mL of extraction solvent is used for every 100 g of medicinal material; when the extraction is performed three times, 800-1000 mL, 800-1000 mL, and 600-800 mL of extraction solvent are used for every 100 g of medicinal material, respectively.

7. A traditional Chinese medicine preparation comprising the traditional Chinese medicine composition according to any one of claims 1-4 and pharmaceutically acceptable excipients or excipients; preferably, the traditional Chinese medicine preparation is a solution, powder, spray, syrup, suppository, tablet, pill, granule, capsule, injection or enteric-coated sustained-release preparation.

8. The use of the traditional Chinese medicine composition according to any one of claims 1-4 or the traditional Chinese medicine preparation according to claim 7 in the preparation of drugs, health products or functional foods for the prevention or treatment of Alzheimer's disease.

9. The use as claimed in claim 8, wherein the senile dementia is Alzheimer's disease, vascular dementia, or Lewy body dementia.

10. The use as claimed in claim 8, wherein the Alzheimer's disease is Alzheimer's disease induced or accompanied by any of the following diseases during the development or treatment: neurological dysfunction, neurodegenerative disease, traumatic brain injury, or cancer.

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