Traditional Chinese medicine composition for treating Alzheimer's disease

Abstract

The invention provides a traditional Chinese medicine composition for treating Alzheimer's disease. Relates to the technical field of traditional Chinese medicine preparations, the weight part ratio of rhizoma polygonati to radix astragali is 1: (1-1.2), a progressive increase type structure is adopted among rhizoma polygonati, radix astragali and poria cocos, and the progressive increase type structure meets the condition that radix astragali is larger than or equal to poria cocos and is larger than or equal to rhizoma polygonati; the sum of the parts by weight of the basic support components accounts for 40-55% of the total parts by weight of the traditional Chinese medicine composition. According to the traditional Chinese medicine composition for treating the Alzheimer's disease, the basic support component, the collateral dredging and regulating component and the active intervention component are reasonably distributed through a definite fixed matching structure, and it is ensured that all the components cooperate with one another and act more stably. By setting an incremental structure and a bidirectional locking proportional structure between the medicinal materials, the composition fluctuation is reduced, so that the composition of each batch has higher consistency, and the stability of the treatment effect of the medicine is enhanced.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, specifically a traditional Chinese medicine composition for treating Alzheimer's disease. Background Technology

[0002] Currently, Alzheimer's disease is a neurodegenerative disease, with main symptoms including memory decline, cognitive impairment, and behavioral changes. Modern medical research has identified multiple pathogenic factors, including nerve cell damage, amyloid protein deposition, and inflammatory responses. Existing treatments are primarily based on Western medicine. These medications improve some symptoms and slow disease progression. Traditional Chinese medicine (TCM) has accumulated experience in brain regulation. Common methods include tonifying the liver and kidneys, promoting blood circulation and unblocking collaterals, and strengthening the spleen and resolving phlegm. Related studies have recorded the neuroprotective and antioxidant effects of herbal medicines. The preparation methods of TCM compositions are relatively mature. Common dosage forms include granules, pills, and oral liquids. Some formulas are used for the management of mild cognitive impairment. Clinical and experimental data are increasing year by year. Researchers have reached a relatively consistent approach in the selection of medicinal materials and preparation methods. Research on the intervention of TCM in cognitive impairment continues to advance.

[0003] However, existing traditional Chinese medicine (TCM) compositions still have significant shortcomings. Most compositions fail to establish stable component structures targeting the main pathological processes of Alzheimer's disease. The proportions of medicinal materials are often based on experience, lacking clear targeting and exhibiting insufficient focus on the relationships between medicinal properties. The synergistic effects between different medicinal materials lack clear definition, preparation steps are not uniformly implemented in research, and component content fluctuates significantly. The overall direction of these compositions is difficult to focus on the key nodes of cognitive impairment, resulting in unstable efficacy. Therefore, a TCM composition with clearly defined medicinal properties, a well-defined proportion and structure, and targeting the core pathological mechanisms has become a real need. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this invention provides a traditional Chinese medicine composition for treating Alzheimer's disease. The technical problem this invention aims to solve is how to address the lack of stable component structures targeting the main pathological processes of Alzheimer's disease and the lack of concentrated pharmacodynamic relationships in existing technologies through precise formulation and clear formulation structure.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a traditional Chinese medicine composition for treating Alzheimer's disease, comprising: the traditional Chinese medicine composition adopting a fixed ratio structure, wherein the fixed ratio structure includes basic support components, meridian regulation components, and active intervention components.

[0006] The basic support components, by weight percentage, include the following components: Polygonatum sibiricum 10%-20%.

[0007] Astragalus membranaceus 12%-24%.

[0008] Poria cocos 10%-20%.

[0009] The meridian-regulating components, by weight percentage, include the following components: Ligusticum striatum 6%-12%.

[0010] Danshen (Salvia miltiorrhiza) 10%-18%.

[0011] The active intervention ingredient, by weight percentage, includes the following components: Polygala tenuifolia: 6%-12%.

[0012] Acorus 6%-10%.

[0013] Gastrodia elata 6%-12%.

[0014] Preferably, the weight ratio of Polygonatum to Astragalus is 1:1-1.2, and the Polygonatum, Astragalus and Poria cocos adopt an incremental structure, wherein the incremental structure satisfies that Astragalus is greater than or equal to Poria cocos and greater than or equal to Polygonatum.

[0015] Preferably, the total weight of the basic supporting components accounts for 56%-60% of the total weight of the traditional Chinese medicine composition.

[0016] Preferably, the chuanxiong rhizome and the danshen rhizome adopt a two-way locking ratio structure, wherein the weight ratio of the chuanxiong rhizome and the danshen rhizome is limited to a fixed ratio range, and the fixed ratio range is 1:1-1.3.

[0017] Preferably, the weight ratio of Polygala tenuifolia to Acorus tatarinowii is 1:0.8-1.1, and the weight ratio of Gastrodia elata to Polygala tenuifolia is 1:0.8-1.2.

[0018] Preferably, the total weight of the active intervention components accounts for 18%-30% of the total weight of the traditional Chinese medicine composition.

[0019] Preferably, the total weight ratio of the basic support component, the meridian regulation component, and the active intervention component is 3:1:1-1.3.

[0020] Preferably, the basic support component, the vascular regulation component, and the active intervention component are uniformly mixed using a mechanical mixing method. The mixing time for the mechanical mixing method is 12-22 minutes, and the rotation speed for the mechanical mixing method is limited to 45-75 rpm.

[0021] This invention provides a traditional Chinese medicine composition for treating Alzheimer's disease. It possesses the following beneficial effects: The traditional Chinese medicine composition of this invention, through a clearly defined and fixed ratio structure, rationally allocates basic support components, meridian-regulating components, and active intervention components, ensuring a more stable synergy and effect among these components. By setting an incremental structure and a two-way locked ratio structure between medicinal materials, component fluctuations are reduced, resulting in high consistency in each batch of the composition and enhancing the stability of the therapeutic effect.

[0022] This traditional Chinese medicine composition for treating Alzheimer's disease, through its formulation design focusing on the functionality of medicinal materials and employing strict processing control, such as limiting particle size, moisture content, and drying conditions, ensures the consistency of the physical and physiological properties of the composition. By refining the proportions and controlling the process, this composition better addresses the problems of unstable efficacy and lack of concentrated drug properties found in existing technologies, providing a more scientific and precise traditional Chinese medicine treatment plan for Alzheimer's disease. Attached Figure Description

[0023] Figure 1 A classification diagram of the components of traditional Chinese medicine compositions; Figure 2 A proportion diagram of basic support components; Figure 3 This is a diagram showing the proportion of active intervention components. Detailed Implementation

[0024] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0025] Example 1 like Figure 1-3 As shown, this embodiment of the invention provides a traditional Chinese medicine composition for treating Alzheimer's disease, comprising a fixed ratio structure of the traditional Chinese medicine composition, which includes basic support components, meridian regulation components, and active intervention components.

[0026] Basic support ingredients, by weight percentage, include the following components: Polygonatum sibiricum 20%.

[0027] Astragalus 24%.

[0028] Poria cocos 16%.

[0029] The weight ratio of Polygonatum to Astragalus is 1:1.2. Polygonatum, Astragalus, and Poria cocos form an increasing order, satisfying the condition that Astragalus is greater than or equal to Poria cocos, which in turn is greater than or equal to Polygonatum. The total weight of the basic supporting components accounts for 60% of the total weight of the herbal composition. The vascular circulation regulating ingredients, by weight percentage, include the following components: Chuanxiong (Ligusticum striatum) 9%.

[0030] Danshen 11%.

[0031] The two-way locked ratio structure of Ligusticum chuanxiong and Salvia miltiorrhiza means that the weight ratio of Ligusticum chuanxiong and Salvia miltiorrhiza is limited to a fixed ratio range of 1:1.2.

[0032] Active intervention ingredients, by weight percentage, include the following components: Polygala tenuifolia 6.5%.

[0033] Acorus 6%.

[0034] Gastrodia elata 7.5%.

[0035] The weight ratio of Polygala tenuifolia to Acorus tatarinowii is 1:0.9, and the weight ratio of Gastrodia elata to Polygala tenuifolia is 1:1.15. The total weight of the active ingredients accounts for 20% of the total weight of the traditional Chinese medicine composition.

[0036] The total weight ratio of the basic support components, the vascular regulation components, and the active intervention components is 3:1:1. The basic support components, vascular regulation components, and active intervention components are uniformly mixed using a mechanical mixing method. The mixing time for the mechanical mixing method is 12 minutes, and the rotation speed is limited to 45 rpm.

[0037] Preparation method: Composition ratio: Based on the above traditional Chinese medicine formula, the basic support components account for 60% of the composition, the collateral regulation components account for 20%, and the active intervention components account for 20%.

[0038] Pulverization: The medicinal materials are pulverized, and the particle size is controlled at 80 mesh to ensure the uniformity of the medicinal material particles and their physiological characteristics of easy absorption.

[0039] Mixing process: Low-speed mechanical mixing is used, with a mixing speed set at 45 rpm and a mixing time of 12 minutes. This low-speed, short-time mixing method helps reduce damage to the medicinal materials and preserve their physiological properties.

[0040] Drying and processing: The mixed medicinal samples were vacuum dried at a temperature of 50°C to maintain the moisture content of the medicinal materials within the range of 6% to 8%.

[0041] Particle shaping: The dried powder is screened to select uniform particles with a particle size of 80 mesh to ensure the consistency of the composition.

[0042] 3. Drug characteristics Particle size: The particle size is 80 mesh, ensuring the drug's absorption and bioavailability in the human body. Moisture content: After vacuum drying, the moisture content is controlled at 8%, ensuring the long-term stability of the drug. Specific surface area: The specific surface area of ​​the powder is approximately 1.2 m². 2 / g, which improves the surface reactivity of the drug and promotes the solubility of traditional Chinese medicine.

[0043] 4. Drug efficacy Experimental results demonstrate that the traditional Chinese medicine composition can improve cognitive function in a mouse model of Alzheimer's disease. Specifically, the effects are as follows: Improving learning and memory abilities: In the Morris water maze test, the treated mice showed significant improvement in memory ability.

[0044] Neuroprotective effect: Histological analysis showed that the degree of brain nerve cell damage in the treated group mice was lower than that in mice that did not consume the Chinese medicine combination.

[0045] Improved cerebral blood flow: The increased cerebral blood flow in the treatment group mice indicates that the drug combination has a certain effect on improving cerebral blood circulation.

[0046] Example 2 This embodiment provides a traditional Chinese medicine combination for treating Alzheimer's disease, which uses high-speed rotation, long-term mixing and a reasonable ratio of 3:1:1.2 to ensure drug stability and physiological characteristics, and improve the consistency and repeatability of efficacy.

[0047] The traditional Chinese medicine composition adopts a fixed ratio structure, which includes basic support components, collateral regulation components, and active intervention components.

[0048] Basic support ingredients, by weight percentage, include the following components: Polygonatum 19%.

[0049] Astragalus 23%.

[0050] Poria cocos 19%.

[0051] The weight ratio of Polygonatum to Astragalus is 1:1-1.2. Polygonatum, Astragalus, and Poria cocos follow an increasing order, satisfying the condition that Astragalus is greater than or equal to Poria cocos, which in turn is greater than or equal to Polygonatum. The total weight of the basic supporting components accounts for 58% of the total weight of the herbal composition. The vascular circulation regulating ingredients, by weight percentage, include the following components: Chuanxiong (Ligusticum striatum) 9%.

[0052] Danshen 10%.

[0053] The two-way locked ratio structure of Ligusticum chuanxiong and Salvia miltiorrhiza is used. The two-way locked ratio structure means that the weight ratio of Ligusticum chuanxiong and Salvia miltiorrhiza is limited to a fixed ratio range, which is 1:1.1.

[0054] Active intervention ingredients, by weight percentage, include the following components: Polygala tenuifolia 7%.

[0055] Acorus 8%.

[0056] Gastrodia elata 8%.

[0057] The weight ratio of Polygala tenuifolia to Acorus tatarinowii is 1:1.14, and the weight ratio of Gastrodia elata to Polygala tenuifolia is 1:1.14. The total weight of active intervention components accounts for 23% of the total weight of the traditional Chinese medicine composition.

[0058] The total weight ratio of the basic support components, the vascular regulation components, and the active intervention components is 3:1:1.2. The basic support components, vascular regulation components, and active intervention components are uniformly mixed using a mechanical mixing method. The mixing time for the mechanical mixing method is 22 minutes, and the rotation speed is limited to 75 rpm.

[0059] Preparation method Composition ratio: Based on the above traditional Chinese medicine formula, the basic support components account for 58% of the composition, the collateral regulation components account for 19%, and the active intervention components account for 23%, according to the ratio of 3:1:1.2.

[0060] Pulverization: The medicinal materials are pulverized, and the particle size is controlled at 60 mesh to ensure the uniformity of the medicinal material particles and their physiological characteristics of easy absorption.

[0061] Mixing process: High-speed mechanical mixing is used, with the mixing speed set at 75 rpm and the mixing time at 22 minutes. The high speed and long mixing time help to fully and evenly distribute the components and ensure good integration between them.

[0062] Drying and processing: The mixed medicinal material samples were vacuum dried at a temperature of 50°C and a relative humidity of 60% until the moisture content was controlled at 6%.

[0063] Particle shaping: The dried powder is screened to select uniform particles with a particle size of 60 mesh to ensure the consistency of the composition.

[0064] 3. Drug characteristics Particle size: The particle size is 100 mesh, which ensures the absorption and bioavailability of the drug in the human body.

[0065] Moisture content: After vacuum drying, the moisture content is controlled at 6% to ensure the long-term stability of the drug.

[0066] Specific surface area: The specific surface area of ​​the powder is approximately 1.5 m². 2 / g increases the surface reactivity of the drug and promotes its solubility.

[0067] 4. Drug efficacy Experimental results demonstrated that the traditional Chinese medicine composition effectively improved cognitive function in a mouse model of Alzheimer's disease. Specifically, the effects were as follows: Improving learning and memory abilities: In the Morris water maze test, the treated mice showed significant improvement in memory ability.

[0068] Neuroprotective effect: Histological analysis showed that the degree of brain nerve cell damage in the treated group mice was lower than that in mice that did not consume the Chinese medicine combination.

[0069] Improved cerebral blood flow: The increased cerebral blood flow in the treatment group mice indicates that the drug combination has a certain effect on improving cerebral blood circulation.

[0070] Example 3 This embodiment provides a traditional Chinese medicine composition for treating Alzheimer's disease. By using a moderate speed, moderate time mixing and a reasonable ratio of 3:1:1.3, it can effectively improve cognitive impairment in Alzheimer's disease.

[0071] The traditional Chinese medicine composition adopts a fixed ratio structure, which includes basic support components, collateral regulation components, and active intervention components.

[0072] Basic support ingredients, by weight percentage, include the following components: Polygonatum 18%.

[0073] Astragalus 20%.

[0074] Poria cocos 18%.

[0075] The weight ratio of Polygonatum to Astragalus is 1:1.1. Polygonatum, Astragalus, and Poria cocos form an increasing order, satisfying the condition that Astragalus is greater than or equal to Poria cocos, which in turn is greater than or equal to Polygonatum. The total weight of the basic supporting components accounts for 56% of the total weight of the herbal composition. The vascular circulation regulating ingredients, by weight percentage, include the following components: Chuanxiong (Ligusticum striatum) 9%.

[0076] Danshen 10%.

[0077] The two-way locked ratio structure of Ligusticum chuanxiong and Salvia miltiorrhiza is used. The two-way locked ratio structure means that the weight ratio of Ligusticum chuanxiong and Salvia miltiorrhiza is limited to a fixed ratio range, which is 1:1.1.

[0078] Active intervention ingredients, by weight percentage, include the following components: Polygala tenuifolia 8%.

[0079] Acorus 9%.

[0080] Gastrodia elata 8%.

[0081] The weight ratio of Polygala tenuifolia to Acorus tatarinowii is 1:0.8-1.1, and the weight ratio of Gastrodia elata to Polygala tenuifolia is 1:1. The total weight of the active ingredients accounts for 25% of the total weight of the traditional Chinese medicine composition.

[0082] The total weight ratio of the basic support components, the vascular regulation components, and the active intervention components is 3:1:1.3. The basic support components, vascular regulation components, and active intervention components are uniformly mixed using a mechanical mixing method. The mixing time for the mechanical mixing method is 17 minutes, and the rotation speed is limited to 60 rpm.

[0083] Preparation method: Composition ratio: In a ratio of 3:1:1.3, basic support components account for 56% of the composition, circulation regulation components account for 19%, and active intervention components account for 25%.

[0084] Pulverization: The above-mentioned medicinal materials are pulverized, and the particle size is controlled at 80 mesh to ensure the uniformity of the medicinal particles and improve the bioavailability of the drug.

[0085] Mixing process: Medium-speed mechanical mixing is used, with the mixing speed set at 60 rpm and the mixing time set at 17 min.

[0086] Drying and processing: The mixed medicinal samples were vacuum dried at a temperature of 50°C and a relative humidity of 55% until the moisture content was controlled at 7%.

[0087] Particle shaping: The dried powder is screened to select uniform particles with a particle size of 80 mesh to ensure the consistency of the composition.

[0088] 3. Drug characteristics Particle size: The particle size is 80 mesh, which ensures the absorption and bioavailability of the drug in the human body.

[0089] Moisture content: After vacuum drying, the moisture content is controlled at 7% to ensure the long-term stability of the drug.

[0090] Specific surface area: The specific surface area of ​​the powder is approximately 1.4 m². 2 / g, which improves the solubility and bioreactivity of the drug.

[0091] Example 4 1. Experimental Objective The purpose of this study was to verify the therapeutic effect of the traditional Chinese medicine composition on a mouse model of Alzheimer's disease, and to evaluate the effects of the traditional Chinese medicine composition on improving learning and memory abilities and protecting against brain neurological damage.

[0092] 2. Experimental Materials Animal model: Healthy male C57BL / 6J mice, weighing approximately 20–25 g and aged 6–8 weeks.

[0093] Pharmaceutical composition: The traditional Chinese medicine composition of the present invention has the components and proportions as described in the claims.

[0094] Control group: physiological saline.

[0095] Positive control group: conventional Alzheimer's disease medications, such as donepezil.

[0096] 3. Experimental Grouping Treatment group: Administered the herbal composition of this invention by gavage at a dose of 0.2g / day / animal. Control group: Administered an equal volume of physiological saline by gavage. Normal control group: Administered the conventional drug donepezil by gavage at a dose of 5mg / kg / day.

[0097] 4. Experimental Methods Establishment of the mouse model: The mice were acclimatized for one week before the experiment began.

[0098] A mouse model of Alzheimer's disease was established by intraperitoneal injection of streptozotocin (STZ) at a dose of 3 mg / kg for 5 consecutive days.

[0099] After the model was established, it was confirmed that the mice had a decline in cognitive ability. The Morris water maze test was used to assess memory impairment to ensure the successful establishment of the model.

[0100] Treatment process: After the model was established, all mice entered the treatment phase, which lasted for 4 weeks.

[0101] Mice in the treatment group, control group, and positive control group were administered the herbal composition of the present invention by gavage at regular intervals every day. The treatment group was administered the herbal composition of the present invention by gavage, the control group was administered physiological saline by gavage, and the positive control group was administered donepezil by gavage.

[0102] Effectiveness evaluation: Morris water maze test: Mice were subjected to the Morris water maze test before the start of the experiment and after the end of treatment. The test included localization learning and spatial exploration.

[0103] Y-maze experiment: to assess the memory ability of mice and record their exploratory behavior and spatial memory ability in a three-armed maze.

[0104] Immunohistochemical analysis: After the experiment, the Aβ deposition and neuronal damage in the mouse cerebral cortex were analyzed by immunohistochemistry to evaluate the neuroprotective effect.

[0105] 5. Experimental Data Table 1: Effects of different experimental groups on cognitive function and neuroprotective effects in Alzheimer's disease mice.

[0106] Among them, location learning and spatial exploration are represented by the time required, measured in seconds (s).

[0107] Localization learning: Compared with the control group, the mice in the treatment group and the positive control group had less time to find the platform, indicating that the mice in both groups had significant improvements in spatial learning.

[0108] Spatial exploration: The mice in the treatment group and the positive control group swam for significantly longer after the platform was removed than the control group. The treatment group and the positive control group showed higher abilities in spatial memory and spatial cognition.

[0109] Y-maze memory performance: Mice in the treatment group and the positive control group showed better memory ability in the Y-maze experiment and took longer to explore the new arm than the control group.

[0110] Aβ deposition score: Immunohistochemical analysis showed that Aβ deposition was reduced in the brains of mice in the treatment group and the positive control group, and the mice showed stronger neuroprotective effects compared with the control group.

[0111] 6. Experimental Conclusions The traditional Chinese medicine composition can improve the cognitive function of Alzheimer's mice, such as memory, learning and spatial cognition.

[0112] Immunohistochemical analysis revealed reduced Aβ deposition, indicating that the combination of traditional Chinese medicines has a neuroprotective effect and can effectively alleviate neurodegenerative lesions associated with Alzheimer's disease.

[0113] Compared with the control group and the normal control group, the treatment group showed better efficacy, and the traditional Chinese medicine composition has obvious therapeutic potential for Alzheimer's disease.

[0114] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for treating Alzheimer's disease, characterized in that, The application relates to a traditional Chinese medicine composition. The traditional Chinese medicine composition adopts a fixed proportion structure, and the fixed proportion structure comprises basic support components, network regulating components and active intervention components. The basic support components comprise the following components in percentage by weight: Huangqi 12%-24%; The network regulating components comprise the following components in percentage by weight: Chuanxiong 6%-12%; Danshen 10%-18%; The active intervention components comprise the following components in percentage by weight: Yuanzhi 6%-12%; Shichangpu 6%-10%; Tianma 6%-12%. The weight ratio of the Huangqi to the Huangqi is 1:1-1.2, and the Huangqi, the Huangqi and the Fuling adopt an increasing structure, and the increasing structure satisfies Huangqi >= Fuling >= Huangqi. The total weight of the basic support components accounts for 56%-60% of the total weight of the traditional Chinese medicine composition.

2. The traditional Chinese medicine composition for treating Alzheimer's disease according to claim 1, characterized in that: The Chuanxiong and the Danshen adopt a bidirectional locking proportion structure, and the bidirectional locking proportion structure means that the weight ratio of the Chuanxiong to the Danshen is limited in a fixed proportion interval, and the fixed proportion interval is 1:1-1.

3.

3. The traditional Chinese medicine composition for treating Alzheimer's disease according to claim 1, characterized in that: The weight ratio of the Yuanzhi to the Shichangpu is 1:0.8-1.1, and the weight ratio of the Tianma to the Yuanzhi is 1:0.8-1.

2.

4. The traditional Chinese medicine composition for treating Alzheimer's disease according to claim 1, characterized in that: The total weight of the active intervention components accounts for 18%-30% of the total weight of the traditional Chinese medicine composition.

5. The traditional Chinese medicine composition for treating Alzheimer's disease according to claim 1, characterized in that: The total weight ratio of the basic support components, the network regulating components and the active intervention components is 3:1:1-1.

3.

6. The traditional Chinese medicine composition for treating Alzheimer's disease according to claim 1, characterized in that: The basic support components, the network regulating components and the active intervention components are uniformly mixed by adopting a mechanical mixing mode, the mixing time of the mechanical mixing mode is 12min-22min, and the rotation speed of the mechanical mixing mode is limited to 45rpm-75rpm.

7. The traditional Chinese medicine composition for treating Alzheimer's disease according to claim 1, characterized in that: ​ 8. The traditional Chinese medicine composition for treating Alzheimer's disease according to claim 1, characterized in that: ​

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