A traditional Chinese medicine composition for treating Alzheimer's disease and a preparation method thereof

Abstract

The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating Alzheimer's disease and a preparation method thereof, the composition is prepared by mixing 8-12 parts of ginseng, 8-10 parts of radix polygoni multiflori, 6-10 parts of chuanxiong rhizome, 5-10 parts of ginkgo leaves, 2-6 parts of prepared rhizome, 9-12 parts of astragalus root, 1-3 parts of gastrodia elata blume, 6-9 parts of atractylodes rhizome, 7-10 parts of yizhi ren, and 10-12 parts of medlar, preferably in a weight ratio of 10:9:8:9:4:10:2:7:8:11. The water extraction and alcohol extraction combination extraction process is used to prepare a pharmaceutically acceptable dosage form such as a capsule after vacuum concentration and vacuum drying. The application has the effects of tonifying qi and kidney, promoting blood circulation and reducing phlegm, and opening orifices and benefiting intelligence, can significantly improve the symptoms such as memory loss and cognitive impairment of patients, effectively delay the progression of the disease, has high safety, no obvious toxic and side effects, and can be taken for a long time, and provides a safe and effective traditional Chinese medicine preparation for the clinical treatment of Alzheimer's disease.

Description

Technical Field

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

[0002] With the increasing aging of the global population, Alzheimer's disease (AD) has become a serious public health problem. Currently, commonly used Western medicines such as cholinesterase inhibitors and NMDA receptor antagonists can temporarily relieve symptoms, but they cannot reverse the course of the disease, and long-term use is often accompanied by side effects such as gastrointestinal reactions and dizziness, thus limiting their efficacy.

[0003] Traditional Chinese medicine (TCM) has unique advantages in the treatment of Alzheimer's disease (AD) due to its multi-component, multi-target, and holistic regulatory effects. Modern pharmacological studies have shown that drug pairs such as Acorus tatarinowii and Polygala tenuifolia can improve cognition through anti-inflammatory, antioxidant, and neurotransmitter regulation pathways.

[0004] Existing compound prescriptions lack specificity. Although some traditional Chinese medicine combinations can tonify the kidneys and replenish essence, they neglect the crucial role of phlegm and blood stasis in the course of Alzheimer's disease, resulting in insufficient ability to expel pathogens and difficulty in effectively clearing pathological products in the brain's meridians, thus failing to achieve optimal clinical efficacy.

[0005] Traditional preparation methods often involve simple water decoction, which makes it difficult to fully extract fat-soluble active ingredients such as ginkgo flavonoids and anthraquinones from herbs like Polygonum multiflorum and Ginkgo biloba leaves, leading to the loss of medicinal substances. Furthermore, the high-temperature concentration process can easily damage heat-sensitive components such as ginsenosides, affecting the bioavailability of the preparation. Summary of the Invention

[0006] (a) Technical problems to be solved In view of the shortcomings of the prior art, the present invention provides a traditional Chinese medicine composition for treating Alzheimer's disease and its preparation method.

[0007] (II) Technical Solution To achieve the above objectives, the present invention provides the following technical solution: a traditional Chinese medicine composition for treating Alzheimer's disease, made from the following raw materials in parts by weight: ginseng 8-12 parts, Polygonum multiflorum 8-10 parts, Ligusticum chuanxiong 6-10 parts, Ginkgo biloba leaf 5-10 parts, Rehmannia glutinosa 2-6 parts, Astragalus membranaceus 9-12 parts, Gastrodia elata 1-3 parts, Acorus tatarinowii 6-9 parts, Alpinia oxyphylla 7-10 parts, and Lycium barbarum 10-12 parts.

[0008] Further preferred formulations are made from the following raw materials in parts by weight: 10 parts ginseng, 9 parts Polygonum multiflorum, 8 parts Ligusticum chuanxiong, 9 parts Ginkgo biloba, 4 parts Rehmannia glutinosa, 10 parts Astragalus membranaceus, 2 parts Gastrodia elata, 7 parts Acorus tatarinowii, 8 parts Alpinia oxyphylla, and 11 parts Lycium barbarum.

[0009] More preferably, the traditional Chinese medicine composition is prepared into any pharmaceutically acceptable dosage form, including capsules, tablets, granules, pills, powders, and oral liquids.

[0010] Preferably, the dosage form is a capsule, and the contents of the capsule are a brownish-yellow to brownish-brown powder with a slightly fragrant odor and a slightly bitter taste.

[0011] Preferably, a method for preparing a traditional Chinese medicine composition for treating Alzheimer's disease includes the following steps: S1. Weigh each raw material according to the weight proportions, remove impurities, wash and dry them, grind them into coarse powder, and mix them evenly to obtain mixed medicinal materials. S2, add 8-12 times the amount of purified water to the mixed medicinal materials, soak for 30-60 minutes, then heat and decoct 2-3 times, each time for 1-2 hours, combine the decoctions, and filter to obtain the first filtrate; S3. Add 6-10 times the volume of 60%-80% ethanol solution to the dregs filtered in step S2, heat and reflux to extract 1-2 times, 1-1.5 hours each time, combine the extracts, and filter to obtain the second filtrate. S4. Concentrate the first and second filtrates under reduced pressure to a relative density of 1.10-1.25 g / cm³. 3 The clear extracts were combined and then concentrated under reduced pressure until the relative density reached 1.30-1.35 g / cm³. 3 A thick paste; S5. Place the thick paste in a vacuum drying oven and vacuum dry it to constant weight at 60-70℃ and -0.08 to -0.06MPa to obtain a dry extract. S6. Grind the dry extract into a fine powder, pass it through an 80-100 mesh sieve, add an appropriate amount of pharmaceutically acceptable excipients, mix well, and then prepare the corresponding dosage form.

[0012] In a further preferred embodiment, in step S2, 10 times the amount of purified water is added to the mixed medicinal materials, soaked for 45 minutes, and then heated and decocted twice, each time for 1.5 hours.

[0013] In a further preferred embodiment, in step S3, 8 times the volume of 70% ethanol solution is added to the residue, and the mixture is heated and refluxed twice, each time for 1 hour.

[0014] More preferably, in step S4, the first filtrate and the second filtrate are concentrated under reduced pressure to a relative density of 1.15-1.20 g / cm³. 3 The extracts were combined and then further concentrated until the relative density reached 1.32-1.33 g / cm³. 3 A thick paste.

[0015] More preferably, in step S5, the vacuum drying temperature is 65°C and the vacuum degree is -0.07MPa.

[0016] More preferably, in step S6, the excipient is one or more of starch, dextrin, microcrystalline cellulose, and magnesium stearate, and when the dosage form is a capsule, the uniformly mixed fine powder is filled into an empty capsule, with each capsule containing 0.3-0.5g.

[0017] (III) Beneficial Effects Compared with the prior art, the present invention provides a traditional Chinese medicine composition for treating Alzheimer's disease and its preparation method, which has the following beneficial effects: This application is based on the pathogenesis theory of kidney essence deficiency and phlegm-blood stasis obstructing the orifices in Traditional Chinese Medicine. It selects ginseng, astragalus, rehmannia, he shou wu, and wolfberry to greatly replenish vital energy and nourish essence and marrow, addressing the root cause. It combines chuanxiong and ginkgo leaves to invigorate blood and remove blood stasis, and calamus and gastrodia to resolve phlegm and open the orifices, addressing the symptoms. The combined effects of these herbs tonify the kidneys and brain, invigorate blood and unblock collaterals, resolve phlegm and open the orifices, effectively improving memory impairment and cognitive function, and slowing disease progression.

[0018] This application employs a combined extraction process of water decoction followed by alcohol extraction. Water decoction effectively extracts water-soluble components such as ginsenosides and astragalus polysaccharides; alcohol extraction fully dissolves fat-soluble active substances such as ginkgo flavonoids and anthraquinones from Polygonum multiflorum. Combined with low-temperature vacuum drying technology at 60-70℃, this avoids the destruction of heat-sensitive components by high temperatures, significantly improving the purity and bioavailability of the drug.

[0019] This application precisely defines key parameters such as the extraction solvent ratio, reflux time, and concentration density, including a 10-fold increase in water extraction, a 70% concentration in alcohol extraction, and a thick paste density of 1.32-1.33 g / cm³. 3 This standardized process not only ensures a high degree of consistency in quality between batches, but also effectively removes impurities, resulting in capsules with uniform color and good flowability, which facilitates industrial production and quality control.

[0020] The capsules prepared in this application mask the bitterness of traditional Chinese medicine, and the dosage is small and the absorption is rapid, making them particularly suitable for long-term use by elderly Alzheimer's patients with impaired swallowing function, and they have good clinical application value. Attached Figure Description

[0021] Figure 1 This is a flowchart of the method for preparing the traditional Chinese medicine composition of the present invention; Figure 2 This is a diagram illustrating the principal, assistant, adjuvant, and guide principles of the traditional Chinese medicine composition of this invention. Detailed Implementation

[0022] 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.

[0023] Please see Figure 1-2 The present invention discloses a traditional Chinese medicine composition for treating Alzheimer's disease, which is made from the following raw materials in parts by weight: ginseng 8-12 parts, Polygonum multiflorum 8-10 parts, Ligusticum chuanxiong 6-10 parts, Ginkgo biloba leaf 5-10 parts, Rehmannia glutinosa 2-6 parts, Astragalus membranaceus 9-12 parts, Gastrodia elata 1-3 parts, Acorus tatarinowii 6-9 parts, Alpinia oxyphylla 7-10 parts, and Lycium barbarum 10-12 parts.

[0024] This treatment plan is based on the traditional Chinese medicine theory of Alzheimer's disease pathogenesis, which is characterized by deficiency of the root and excess of the branch. The root deficiency is kidney deficiency and marrow depletion, and insufficient qi and blood, while the branch excess is phlegm and blood stasis obstructing the orifices and hindering the brain's circulation. The treatment principle is to invigorate qi and kidney, promote blood circulation and resolve phlegm, and open the orifices and improve intelligence. Ten carefully selected authentic medicinal materials are scientifically combined with modern pharmaceutical technology to achieve multi-target synergistic treatment.

[0025] (I) Theoretical Basis of Traditional Chinese Medicine Compatibility This formula follows the classic principle of monarch-minister-assistant-guide in traditional Chinese medicine, forming a multi-layered and synergistic compound system: The principal herbs are ginseng and he shou wu. Ginseng greatly replenishes vital energy, calms the mind and improves intelligence; he shou wu nourishes the liver and kidneys, benefits essence and blood, and strengthens muscles and bones. It targets the root deficiency of kidney deficiency and marrow depletion, and insufficient qi and blood, and nourishes the foundation of both prenatal and postnatal health. Assistant herbs: Ligusticum chuanxiong, Ginkgo biloba leaf, Rehmannia glutinosa, Astragalus membranaceus. Ligusticum chuanxiong invigorates blood circulation, promotes qi circulation, dispels wind and relieves pain; Ginkgo biloba leaf invigorates blood circulation, removes blood stasis, unblocks collaterals and relieves pain; Rehmannia glutinosa nourishes yin and blood, benefits essence and fills marrow; Astragalus membranaceus tonifies qi and raises yang, consolidates the exterior and stops sweating. These herbs assist the principal herbs in enhancing the qi-tonifying and blood-nourishing effects, while also invigorating blood circulation, removing blood stasis, and unblocking brain collaterals. The adjuvant herbs are: Gastrodia elata, Acorus tatarinowii, and Alpinia oxyphylla. Gastrodia elata calms wind and stops spasms, and suppresses liver yang; Acorus tatarinowii opens the orifices, resolves phlegm, and refreshes the mind and improves intelligence; Alpinia oxyphylla warms the kidneys, consolidates essence, warms the spleen, and stops diarrhea. These herbs target the symptoms of phlegm and blood stasis obstructing the orifices, open the orifices, refresh the mind, resolve phlegm, and unblock the meridians. The guiding herb is wolfberry, which nourishes the liver and kidneys, benefits essence and improves eyesight, harmonizes the effects of other herbs, guides the herbs into the kidney meridian, and harmonizes the properties of the entire formula. When used together, these herbs work synergistically to invigorate Qi without causing stagnation, promote blood circulation without harming the body's vital energy, tonify the kidneys without being cloying, and open the orifices without depleting Qi, thus addressing the core pathogenesis of Alzheimer's disease.

[0026] (II) Modern Pharmacological Mechanism of Action The therapeutic effect of this regimen is achieved through modern pharmacological mechanisms involving multiple targets and pathways: Inhibiting β-amyloid (Aβ) deposition: Ginsenosides Rg1 and Rb1, Polygonum multiflorum stilbene glycosides, Ginkgo biloba flavonoids and other components can inhibit the generation, aggregation and fibrosis of Aβ and promote the clearance of Aβ. Inhibiting tau protein hyperphosphorylation: Tetramethylpyrazine and gastrodin can reduce tau protein phosphorylation levels and decrease the formation of neurofibrillary tangles. Improving cerebral circulation and energy metabolism: Ginkgo biloba extract and ligustrazine can dilate cerebral blood vessels, increase cerebral blood flow, and improve the energy supply to brain cells; Antioxidant and neuroprotective effects: Lycium barbarum polysaccharides, Astragalus membranaceus polysaccharides, and Polygonum multiflorum stilbene glycosides have strong antioxidant activity, which can scavenge free radicals and reduce the damage of oxidative stress to nerve cells; Inhibiting neuroinflammation: Ginsenosides and Acorus tatarinowii volatile oil can inhibit the excessive activation of microglia and reduce the release of pro-inflammatory factors; Promoting nerve regeneration and synaptic plasticity: Ginsenoside Rg1 and Alpinia oxyphylla volatile oil can promote the proliferation and differentiation of neural stem cells and improve synaptic transmission function; The weight range of this prescription is 8-12 parts for ginseng. Less than 8 parts will result in insufficient qi-tonifying effect, while more than 12 parts may easily lead to internal heat. The weight range of He Shou Wu is 8-10 parts, which can ensure the efficacy of tonifying the liver and kidneys, while avoiding the risk of liver damage that may be caused by long-term use.

[0027] The optimal weight ratio is: 10 parts ginseng, 9 parts he shou wu, 8 parts chuan xiong, 9 parts ginkgo leaves, 4 parts shu rehmannia, 10 parts astragalus, 2 parts gastrodia, 7 parts shi chang pu, 8 parts yi zhi ren, and 11 parts gou qi. Under this ratio, the synergistic effect of the drugs is the strongest and the clinical efficacy is the highest.

[0028] Medicinal material quality control: All raw materials should comply with the relevant provisions of Part I of the 2025 edition of the Pharmacopoeia of the People's Republic of China, and priority should be given to the selection of authentic medicinal materials, such as Jilin ginseng, Sichuan Polygonum multiflorum, and Ningxia wolfberry, to ensure the stability of the content of effective ingredients.

[0029] Feasibility: Those skilled in the art can accurately weigh each active pharmaceutical ingredient according to the weight range disclosed in this application without any inventive effort. The quality standards for medicinal materials can be directly implemented with reference to the pharmacopoeia, and the identification of authentic medicinal materials can be achieved by combining traditional morphological identification with modern fingerprinting technology.

[0030] The traditional Chinese medicine composition in this solution can be prepared into any pharmaceutically acceptable dosage form, including capsules, tablets, granules, pills, powders, oral liquids, etc., to meet the medication needs of different patients.

[0031] Preferred dosage form: Capsules are the preferred dosage form of this invention, and have the following advantages: It masks the unpleasant odor and bitter taste of medications, thereby improving patient compliance; The drug is rapidly dispersed, dissolved, and absorbed in the gastrointestinal tract, resulting in high bioavailability; It can protect the drug from the effects of light, air, and moisture, thus improving its stability; Accurate dosage, convenient administration, easy to carry and store; Capsule properties control: The contents of the capsules are brownish-yellow to brownish-brown powder with a slightly fragrant odor and a slightly bitter taste. This is determined by the medicinal material composition and extraction process of this invention and can be used as a preliminary identification indicator of product quality.

[0032] Feasibility Notes: All dosage forms are prepared using standard pharmaceutical formulation techniques and equipment. Capsules can be prepared using a fully automated capsule filling machine, and empty capsules can be made using gelatin empty capsules or plant-based empty capsules that meet national standards.

[0033] The preparation process employs advanced extraction, concentration, and drying technologies to retain the effective components in the medicinal materials to the maximum extent, ensuring the quality and efficacy of the product.

[0034] Step S1: Raw material pretreatment Remove impurities, wash, and dry: Remove mud, sand, impurities, and non-medicinal parts from the medicinal materials to ensure their purity; Grind into coarse powder: Grind the medicinal materials into coarse powder of 10-20 mesh to increase the contact area between the medicinal materials and the solvent and improve the extraction efficiency; Uniform mixing: This ensures that each medicinal herb is evenly contacted with the solvent during the extraction process, avoiding local concentrations that are too high or too low. Step S2 Water Extraction Process: Extraction principle: Water is used as a solvent to extract water-soluble active ingredients from medicinal materials, such as ginsenosides, astragalus polysaccharides, wolfberry polysaccharides, alkaloids, etc. Add 8-12 times the amount of purified water to ensure that the medicinal materials are fully submerged; Soaking time: 30-60 minutes, to allow the herbs to fully absorb water and swell, which is conducive to the dissolution of active ingredients; Number of decoctions and time: Decoction 2-3 times, 1-2 hours each time. The first decoction can extract about 70% of the water-soluble active ingredients, the second decoction can extract about 20%, and the third decoction can extract about 10%. Too many decoctions will increase the amount of impurities extracted. Step S3 alcohol extraction process: Extraction principle: Using ethanol as a solvent, fat-soluble active ingredients in medicinal materials are extracted, such as ginkgo leaf flavonoids, ligustrazine, gastrodin, and volatile oil of acorus tatarinowii. Ethanol concentration: 60%-80% ethanol solution. This concentration range can extract most of the fat-soluble active ingredients while reducing the extraction of water-soluble impurities such as proteins, starches, and mucilage. Add 6-10 times the amount of ethanol solution to ensure that the residue is fully submerged; Number of reflux extractions and time: Heat and reflux extract 1-2 times, 1-1.5 hours each time. Reflux extraction can prevent ethanol evaporation and improve extraction efficiency. Step S4 Concentration Process: Concentration principle: The solvent is removed at a lower temperature using vacuum concentration technology, thereby increasing the concentration of the drug solution; Relative density of the ointment: 1.10-1.25 g / cm³ 3 At 60℃, the paste in this density range has good fluidity, making it easy to transfer and combine, while its moderate water content is beneficial for subsequent drying. The relative density of the thick paste is 1.30-1.35 g / cm³. 3 At 60℃, the moisture content of the thick paste in this density range is about 20%-30%, the drying time is short, and it is not easy to stick to the wall; Step S5 Vacuum drying process: Drying principle: Under vacuum conditions, the boiling point of water decreases, allowing for rapid drying at lower temperatures and preventing the decomposition of heat-sensitive active ingredients; Drying temperature: 60-70℃. This temperature range ensures drying efficiency without damaging heat-sensitive components such as ginsenosides and stilbene glycosides. Vacuum degree: -0.08 to -0.06 MPa. A higher vacuum degree can lower the boiling point of water and accelerate the drying speed. Dry to constant weight: Ensure the moisture content of the dry extract is below 5% to improve product stability; Step S6 Formulation Process: Grinding and sieving: Grind the dry extract into fine powder and pass it through an 80-100 mesh sieve to ensure uniform particle size, which is beneficial for subsequent mixing and filling. Adding excipients and mixing: Add appropriate amounts of pharmaceutically acceptable excipients, such as starch, dextrin, microcrystalline cellulose, magnesium stearate, etc., to adjust the flowability and compressibility of the powder; Formulate into appropriate dosage forms: Formulate into different dosage forms such as capsules, tablets, and granules as needed; Feasibility statement: All preparation steps utilize conventional equipment and technologies found in the pharmaceutical industry, such as universal pulverizers, multi-functional extraction tanks, vacuum concentration tanks, vacuum drying ovens, tank mixers, and capsule filling machines. Those skilled in the art can directly perform production operations based on the process parameters disclosed in this application, without requiring any inventive effort.

[0035] Optimal formula ratio: Ginseng 10 parts, Polygonum multiflorum 9 parts, Ligusticum chuanxiong 8 parts, Ginkgo biloba 9 parts, Rehmannia glutinosa 4 parts, Astragalus membranaceus 10 parts, Gastrodia elata 2 parts, Acorus tatarinowii 7 parts, Alpinia oxyphylla 8 parts, Lycium barbarum 11 parts.

[0036] Preferred water extraction process: Preferred method: Add 10 times the amount of purified water, soak for 45 minutes, then heat and decoct twice, 1.5 hours each time; 10 times the amount of water: This ensures that the medicinal materials are fully submerged without causing the concentration time to be too long due to excessive water. Soaking for 45 minutes is the optimal time for medicinal herbs to fully absorb water and swell. Soaking for less than 30 minutes will result in insufficient water absorption, while soaking for more than 60 minutes can easily lead to mold and spoilage. Boil twice, 1.5 hours each time: This can extract about 90% of the water-soluble active ingredients, while avoiding the decomposition of heat-sensitive components due to excessive boiling time.

[0037] Optimal alcohol extraction process: Add 8 times the volume of 70% ethanol solution, heat and reflux twice, 1 hour each time; 70% ethanol: This is the optimal concentration for extracting the fat-soluble active ingredients in this invention. At this concentration, the extraction rates of ginkgo flavonoids and ligustrazine are the highest, while the amount of impurities extracted is the lowest. Eight times the amount of ethanol: to ensure the residue is fully submerged and to improve extraction efficiency; Reflux extraction twice, one hour each time: This can extract about 95% of the fat-soluble active ingredients, while avoiding the loss of volatile oils due to excessive extraction time; Preferred concentration process: The first and second filtrates were concentrated under reduced pressure to a relative density of 1.15-1.20 g / cm³. 3 The extracts were concentrated at 60℃, combined, and then further concentrated until the relative density reached 1.32-1.33 g / cm³. 3 A thick paste at 60℃; The relative density of the extract is 1.15-1.20 g / cm³. 3 60℃: The paste has the best flowability in this density range, which is convenient for pipeline transportation and merging, and at the same time, it is not easy to produce foam; The relative density of the thick paste is 1.32-1.33 g / cm³. 3 60℃: Thick pastes in this density range have a water content of about 25%, the shortest drying time, and are less prone to sticking to the walls and charring.

[0038] Preferred vacuum drying process: Preferred method: Vacuum drying temperature is 65℃, vacuum degree is -0.07MPa; 65℃: This is the optimal balance between drying efficiency and retention rate of active ingredients. At this temperature, the drying time is approximately 8-12 hours, and the retention rate of ginsenosides and stilbene glycosides can reach over 95%. -0.07MPa: At this vacuum level, the boiling point of water is approximately 45℃, enabling rapid low-temperature drying and preventing the decomposition of active ingredients.

[0039] Preferred formulation forming process: The excipients are starch and magnesium stearate, and the dosage form is capsules, with each capsule containing 0.3-0.5g. Starch: It is the most commonly used diluent and disintegrant. It is inexpensive, stable, and can improve the flowability and compressibility of powders. Magnesium stearate: a commonly used lubricant that reduces friction between powder and capsule filling machine, ensuring smooth filling; Each capsule contains 0.3-0.5g: This is the optimal dosage for adults to take at one time, ensuring efficacy without causing adverse reactions due to excessive dosage.

[0040] Detailed workflow, fully traceable and repeatable: Raw material acceptance and pretreatment: Raw material acceptance: In accordance with the standards of Part I of the 2025 edition of the Pharmacopoeia of the People's Republic of China, 10 raw materials including ginseng, Polygonum multiflorum, and Ligusticum chuanxiong are inspected for properties, identification, moisture, ash content, heavy metals and harmful elements, pesticide residues, etc. Only those that pass the inspection can be put into storage.

[0041] Cleaning: Cleaning the accepted medicinal materials to remove impurities, non-medicinal parts, and moldy products.

[0042] Drying: Place the cleaned medicinal materials in a hot air circulating oven and dry them at a temperature below 60°C until the moisture content does not exceed 12%.

[0043] Grinding: Grind the dried medicinal materials into coarse powder of 10-20 mesh using a universal pulverizer.

[0044] Mixing: Weigh out the coarse powder of each medicinal material according to the prescription weight parts, place them in a three-dimensional motion mixer and mix for 30 minutes to obtain a uniformly mixed medicinal material.

[0045] Water extraction: Place the mixed medicinal materials into a multi-functional extraction tank, add 10 times the amount of purified water, and soak for 45 minutes.

[0046] Turn on the heating steam and heat to boiling. Then maintain a gentle boil and simmer for 1.5 hours. Turn off the heating steam, open the liquid outlet valve, and filter the decoction through a 200-mesh sieve into a storage tank to obtain the first decoction.

[0047] Add 8 times the amount of purified water to the extraction tank, heat to boiling, and then simmer for 1.5 hours. Turn off the heating steam, filter the decoction through a 200-mesh sieve into the storage tank, and combine it with the first decoction to obtain the first filtrate.

[0048] Alcohol extraction: After water extraction, drain the residue and add 8 times the volume of 70% ethanol solution, then stir well.

[0049] Turn on the heating steam and heat until the ethanol refluxes. Maintain the reflux state for 1 hour, then turn off the heating steam and filter the extract through a 200-mesh sieve into a storage tank to obtain the first alcohol extract.

[0050] Add 6 times the volume of 70% ethanol solution to the extraction tank, heat to reflux, maintain reflux for 1 hour, turn off the heating steam, filter the extract through a 200-mesh sieve into the storage tank, and combine it with the first ethanol extract to obtain the second filtrate.

[0051] Reduced pressure concentration: The first filtrate was pumped into a vacuum concentration tank and concentrated under reduced pressure at 60°C and -0.07 MPa to a relative density of 1.15-1.20 g / cm³. 3 The ointment, heated to 60°C, is released into the ointment storage tank.

[0052] The second filtrate was pumped into another vacuum concentration tank and concentrated under reduced pressure at 60°C and -0.07 MPa to a relative density of 1.15-1.20 g / cm³. 3 The 60°C extract is poured into the same extract storage tank, combined with the water-extracted extract, and stirred evenly.

[0053] The combined extract was pumped into a vacuum concentration tank and concentrated under reduced pressure at 60℃ and -0.07MPa until the relative density reached 1.32-1.33 g / cm³. 3 The 60℃ thick paste was poured into a clean stainless steel container.

[0054] Vacuum drying: Spread the thick paste evenly on the tray of the vacuum drying oven, with a layer thickness of 1-2 cm.

[0055] Close the vacuum drying oven door, turn on the vacuum pump, evacuate to -0.07MPa, then turn on the heating system and raise the temperature to 65℃. Maintain the vacuum level and temperature for drying.

[0056] During the drying process, the vacuum drying oven is opened every 2 hours, and the material is turned over once until the material is dried to constant weight. The difference between two consecutive weighings does not exceed 0.3%, and the dry extract is obtained.

[0057] Formulation: Grinding and sieving: Grind the dry extract into fine powder using a universal grinder, pass it through a 100-mesh sieve, and collect the material passing through the sieve.

[0058] Mixing: Place the dry extract powder in a trough mixer, add an appropriate amount of starch, about 10% of the weight of the dry extract, mix for 15 minutes, then add 0.5% magnesium stearate and continue mixing for 5 minutes to obtain a uniform mixed powder.

[0059] Capsule filling: The mixed powder is put into a fully automatic capsule filling machine and filled into No. 0 gelatin empty capsules. Each capsule contains 0.4g, and the filling weight difference is controlled within ±5%.

[0060] Polishing: Place the filled capsules in a capsule polishing machine to remove surface dust and powder.

[0061] Sorting: Manually sorting to remove unqualified products such as empty bags, deflated bags, and damaged bags.

[0062] Packaging and Inspection: Inner packaging: The qualified capsules are packaged using an aluminum-plastic blister packaging machine, with 12 capsules per blister pack.

[0063] Outer packaging: Pack the aluminum composite panels into cardboard boxes, 2 panels per box, add the instruction manual, and seal.

[0064] Finished product inspection: Finished products are inspected in accordance with quality standards, including items such as appearance, identification, content determination, fill weight variation, disintegration time limit, and microbial limits. Only qualified products can be put into storage.

[0065] 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, It is made from the following raw materials in parts by weight: ginseng 8-12 parts, Polygonum multiflorum 8-10 parts, Ligusticum chuanxiong 6-10 parts, Ginkgo biloba leaf 5-10 parts, Rehmannia glutinosa 2-6 parts, Astragalus membranaceus 9-12 parts, Gastrodia elata 1-3 parts, Acorus tatarinowii 6-9 parts, Alpinia oxyphylla 7-10 parts, and Lycium barbarum 10-12 parts.

2. The traditional Chinese medicine composition for treating Alzheimer's disease according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 10 parts ginseng, 9 parts Polygonum multiflorum, 8 parts Ligusticum chuanxiong, 9 parts Ginkgo biloba, 4 parts Rehmannia glutinosa, 10 parts Astragalus membranaceus, 2 parts Gastrodia elata, 7 parts Acorus tatarinowii, 8 parts Alpinia oxyphylla, and 11 parts Lycium barbarum.

3. The traditional Chinese medicine composition for treating Alzheimer's disease according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared into any pharmaceutically acceptable dosage form, including capsules, tablets, granules, pills, powders, and oral liquids.

4. A traditional Chinese medicine composition for treating Alzheimer's disease according to claim 3, characterized in that, The dosage form is a capsule, and the contents of the capsule are a brownish-yellow to brownish-brown powder with a slightly fragrant odor and a slightly bitter taste.

5. The method for preparing a traditional Chinese medicine composition for treating Alzheimer's disease according to any one of claims 1-4, characterized in that, Includes the following steps: S1. Weigh each raw material according to the weight proportions, remove impurities, wash and dry them, grind them into coarse powder, and mix them evenly to obtain mixed medicinal materials. S2, add 8-12 times the amount of purified water to the mixed medicinal materials, soak for 30-60 minutes, then heat and decoct 2-3 times, each time for 1-2 hours, combine the decoctions, and filter to obtain the first filtrate; S3. Add 6-10 times the volume of 60%-80% ethanol solution to the dregs filtered in step S2, heat and reflux to extract 1-2 times, 1-1.5 hours each time, combine the extracts, and filter to obtain the second filtrate. S4. Concentrate the first and second filtrates under reduced pressure to a relative density of 1.10-1.25 g / cm³. 3 The clear extracts were combined and then concentrated under reduced pressure until the relative density reached 1.30-1.35 g / cm³. 3 A thick paste; S5. Place the thick paste in a vacuum drying oven and vacuum dry it to constant weight at 60-70℃ and -0.08 to -0.06MPa to obtain a dry extract. S6. Grind the dry extract into a fine powder, pass it through an 80-100 mesh sieve, add an appropriate amount of pharmaceutically acceptable excipients, mix well, and then prepare the corresponding dosage form.

6. A method for preparing a traditional Chinese medicine composition for treating Alzheimer's disease according to claim 5, characterized in that, In step S2, add 10 times the amount of purified water to the mixed herbs, soak for 45 minutes, then heat and decoct twice, each time for 1.5 hours.

7. A method for preparing a traditional Chinese medicine composition for treating Alzheimer's disease according to claim 5, characterized in that, In step S3, add 8 times the volume of 70% ethanol solution to the residue, and heat and reflux to extract twice, each time for 1 hour.

8. A method for preparing a traditional Chinese medicine composition for treating Alzheimer's disease according to claim 5, characterized in that, In step S4, the first filtrate and the second filtrate are concentrated under reduced pressure to a relative density of 1.15-1.20 g / cm³. 3 The extracts were combined and then further concentrated until the relative density reached 1.32-1.33 g / cm³. 3 A thick paste.

9. A method for preparing a traditional Chinese medicine composition for treating Alzheimer's disease according to claim 5, characterized in that, In step S5, the vacuum drying temperature is 65℃ and the vacuum degree is -0.07MPa.

10. A method for preparing a traditional Chinese medicine composition for treating Alzheimer's disease according to claim 5, characterized in that, In step S6, the excipient is one or more of starch, dextrin, microcrystalline cellulose, and magnesium stearate. When the dosage form is a capsule, the uniformly mixed fine powder is filled into an empty capsule, with each capsule containing 0.3-0.5g.

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