Cimicifuga foetida-containing traditional Chinese medicine composition for treating Alzheimer disease

Abstract

The invention is applicable to the field of medicines, and particularly relates to a rhizoma cimicifugae-containing traditional Chinese medicine composition for treating Alzheimer's disease, which comprises the following components in parts by weight: 5-15 parts of rhizoma cimicifugae, 8-12 parts of ginseng, 10-15 parts of astragalus membranaceus, 6-10 parts of salvia miltiorrhiza, 4-8 parts of rhizoma acori graminei, 3-6 parts of polygala tenuifolia, 5-8 parts of spina date seed, 10-15 parts of poria cocos, 6-10 parts of radix ophiopogonis, 12-18 parts of oyster, 8-12 parts of concha haliotidis and 4-8 parts of gastrodia elata. The cimicifugae foetidae-containing traditional Chinese medicine composition for treating the Alzheimer's disease has the beneficial effects that the cognitive function is improved: the salvia miltiorrhiza, the rhizoma acori graminei and the polygala tenuifolia can promote cerebral blood perfusion, enhance synaptic plasticity and inhibit neuronal apoptosis; the rhizoma cimicifugae and the radix astragali are combined to improve brain microcirculation and reduce beta-amyloid protein aggregation, so that the learning and memory ability is remarkably improved.

Description

Technical Field

[0001] The invention belongs to the field of medicine, and in particular relates to a Chinese medicinal composition containing Cimicifuga heracleifolia for treating Alzheimer's disease. Background Art

[0002] Alzheimer's disease, the most common neurodegenerative disease, affects over 50 million people worldwide. Current mainstream treatments, such as acetylcholinesterase inhibitors (donepezil, etc.) and NMDA receptor antagonists (memantine), only temporarily relieve symptoms but fail to halt disease progression. Lecanemab, an Aβ monoclonal antibody approved by the FDA in 2023, can clear amyloid-β from the brain but carries the risk of ARIA (brain edema / microbleeding).

[0003] Existing drugs are degraded in the intestine, resulting in a loss of >50% of their active ingredients, while injections lack brain targeting, resulting in extremely low drug distribution in the brain and poor therapeutic effects. Summary of the Invention

[0004] The purpose of the present invention is to provide a traditional Chinese medicine composition containing Cimicifuga foetida for treating Alzheimer's disease, aiming to solve the problem that existing drugs are degraded in the intestine, resulting in a loss of active ingredients greater than 50%, while the injection lacks brain targeting, resulting in extremely low brain drug distribution and poor therapeutic effect.

[0005] The present invention is achieved by providing a Chinese medicinal composition containing Cimicifuga heracleifolia for treating Alzheimer's disease, the Chinese medicinal composition comprising:

[0006] By weight, 5-15 parts of Cimicifuga, 8-12 parts of Ginseng, 10-15 parts of Astragalus, 6-10 parts of Salvia miltiorrhiza, 4-8 parts of Acorus calamus, 3-6 parts of Polygala tenuifolia, 5-8 parts of Ziziphus jujuba seeds, 10-15 parts of Poria, 6-10 parts of Ophiopogon japonicus, 12-18 parts of Oyster, 8-12 parts of Semen Cassiae and 4-8 parts of Gastrodia elata.

[0007] Preferably, the Chinese medicine composition comprises:

[0008] By weight, 6-11 parts of Cimicifuga, 10-11 parts of Ginseng, 12-14 parts of Astragalus, 7-9 parts of Salvia miltiorrhiza, 5-7 parts of Acorus calamus, 4-5 parts of Polygala tenuifolia, 6-8 parts of Ziziphus jujuba seeds, 9-15 parts of Poria, 6-8 parts of Ophiopogon japonicus, 12-14 parts of Oyster, 9-11 parts of Semen Cassiae and 5-8 parts of Gastrodia elata.

[0009] Preferably, the Chinese medicine composition comprises:

[0010] By weight, 7 parts of Cimicifuga, 10 parts of Ginseng, 13 parts of Astragalus, 8 parts of Salvia miltiorrhiza, 6 parts of Acorus calamus, 4 parts of Polygala tenuifolia, 7 parts of Semen Ziziphi spinulosae, 11 parts of Poria, 7 parts of Ophiopogon japonicus, 13 parts of Oyster, 10 parts of Semen Cassiae and 6 parts of Gastrodia elata.

[0011] Preferably, the dosage form of the Chinese medicine composition is pills, capsules or oral liquid.

[0012] Preferably, the preparation process of the traditional Chinese medicine composition is: mixing the raw materials according to proportion and grinding them into 100 mesh, adding honey or starch paste to make pills.

[0013] Preferably, the preparation process of the traditional Chinese medicine composition is as follows: boiling and extracting each raw material twice with water in proportion, combining the filtrate and concentrating it into an extract, and adding a flavoring agent to prepare an oral solution.

[0014] Preferably, the relative density of the extract is 1.05-1.10.

[0015] The Chinese medicinal composition for treating Alzheimer's disease containing Cimicifuga provided by the present invention has the following beneficial effects:

[0016] Improve cognitive function: Danshen, Acorus tatarinowii, and Polygala tenuifolia can promote cerebral blood perfusion, enhance synaptic plasticity, and inhibit neuronal apoptosis; Cimicifuga heracleifolia combined with Astragalus membranaceus improves cerebral microcirculation and reduces β-amyloid protein aggregation, thereby significantly improving learning and memory abilities.

[0017] Regulate neurotransmitter balance: Ziziphus jujuba seeds and Gastrodia elata act synergistically on GABA receptors and the 5-HT system, alleviating anxiety, insomnia, and behavioral disorders in AD patients; ginsenosides and astragalus polysaccharides improve cholinergic nerve function by regulating acetylcholinesterase activity;

[0018] Anti-inflammatory and antioxidant: Oysters and Cassia tora are rich in zinc and trace elements, which can scavenge free radicals and inhibit neuroinflammation caused by excessive activation of microglia; Ophiopogon japonicus polysaccharides enhance the activity of antioxidant enzymes through the Nrf2 / ARE pathway and reduce oxidative damage.

[0019] Delaying disease progression: The combination of blood-activating and blood-stasis-removing herbs (Danshen and Astragalus) and orifice-opening and brain-awakening herbs (Acorus gramineus and Polygala tenuifolia) in the composition can intervene in the pathological process of AD in the long term and reduce the rate of neurofibrillary tangle formation.

[0020] High safety: All ingredients are traditional Chinese medicinal materials, without liver and kidney toxicity, and are well tolerated for long-term use, making it especially suitable for elderly patients. DETAILED DESCRIPTION

[0021] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0022] A traditional Chinese medicine composition containing Cimicifuga heracleifolia for treating Alzheimer's disease, comprising:

[0023] By weight, 5-15 parts of Cimicifuga, 8-12 parts of Ginseng, 10-15 parts of Astragalus, 6-10 parts of Salvia miltiorrhiza, 4-8 parts of Acorus calamus, 3-6 parts of Polygala tenuifolia, 5-8 parts of Ziziphus jujuba seeds, 10-15 parts of Poria, 6-10 parts of Ophiopogon japonicus, 12-18 parts of Oyster, 8-12 parts of Semen Cassiae and 4-8 parts of Gastrodia elata.

[0024] Example 1:

[0025] A traditional Chinese medicine composition containing Cimicifuga heracleifolia for treating Alzheimer's disease, comprising:

[0026] The Chinese medicine composition comprises:

[0027] By weight, 7 parts of Cimicifuga, 10 parts of Ginseng, 13 parts of Astragalus, 8 parts of Salvia miltiorrhiza, 6 parts of Acorus calamus, 4 parts of Polygala tenuifolia, 7 parts of Semen Ziziphi spinulosae, 11 parts of Poria, 7 parts of Ophiopogon japonicus, 13 parts of Oyster, 10 parts of Semen Cassiae and 6 parts of Gastrodia elata.

[0028] The pellet preparation process is as follows:

[0029] Pretreatment of medicinal materials: Calcine mineral medicinal materials such as oysters and stone cassia and grind them into coarse powder; other medicinal materials (such as Cimicifuga and ginseng) are cleaned and chopped or crushed to less than 5mm.

[0030] Mixing and crushing: Mix all the medicinal materials in proportion and crush them into 100 mesh using a universal grinder (the passing rate of the sieve inspection is ≥95%).

[0031] Preparation of soft material: Honey method: Take 150g honey (refined honey, water content ≤15%), heat to 70-80℃ to melt, slowly add to the powder and stir until the soft material "clumps when held and falls apart when touched";

[0032] Starch paste method: Take 80g corn starch and add 100ml water to cook into a paste. After cooling, mix it with the medicinal powder to make a soft material.

[0033] Pellet making: Using a rotary pellet making machine (model: ZP-300), the soft material was made into 6 mm diameter pellets (each pellet containing 3 g of crude drug). After pelleting, the pellets were immediately dried (60°C constant temperature oven drying for 4 hours, moisture ≤ 8%).

[0034] Packaging and sterilization: Aluminum-plastic blister packaging (single pill independent packaging); ultraviolet irradiation sterilization (30W UV lamp, distance 10cm, irradiation for 20 minutes).

[0035] The process of preparing oral solution is:

[0036] Medicinal material extraction: Mix the above medicinal materials according to the proportion, add 10 times the amount of water (10L) and boil twice:

[0037] First decoction: heat to boiling and keep for 2 hours, filter to obtain filtrate A;

[0038] Second decoction: add 8L of water and decoct for another 1.5 hours, then filter to obtain filtrate B.

[0039] The filtrates A and B were combined and concentrated under reduced pressure to a relative density of 1.10 (measured at 60°C).

[0040] Clarification and purification: add 0.1% activated carbon (wet addition), stir at 80°C for 30 minutes, and filter to remove carbon;

[0041] The alcohol precipitation method is adopted: add ethanol until the alcohol content reaches 70%, let it stand for 24 hours, then filter and recover the ethanol.

[0042] Preparation and flavoring: Add 0.5g of glycyrrhizin (to improve bitterness) and 0.2g of sodium benzoate (for preservation) to the concentrate and stir until completely dissolved; adjust the pH to 5.5-6.5 (using citric acid).

[0043] Filling and sterilization: Use a fully automatic filling machine to fill into 500ml glass bottles (each 10ml contains 3g of crude drug); sterilize with moist heat at 121℃ for 30 minutes, and package after labeling.

[0044] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A Chinese medicinal composition containing Cimicifuga heracleifolia for treating Alzheimer's disease, characterized in that: The Chinese medicine composition comprises: By weight, 5-15 parts of Cimicifuga, 8-12 parts of Ginseng, 10-15 parts of Astragalus, 6-10 parts of Salvia miltiorrhiza, 4-8 parts of Acorus calamus, 3-6 parts of Polygala tenuifolia, 5-8 parts of Ziziphus jujuba seeds, 10-15 parts of Poria, 6-10 parts of Ophiopogon japonicus, 12-18 parts of Oyster, 8-12 parts of Semen Cassiae and 4-8 parts of Gastrodia elata.

2. The Chinese medicinal composition for treating Alzheimer's disease containing Cimicifuga according to claim 2, characterized in that: The Chinese medicine composition comprises: By weight, 6-11 parts of Cimicifuga, 10-11 parts of Ginseng, 12-14 parts of Astragalus, 7-9 parts of Salvia miltiorrhiza, 5-7 parts of Acorus calamus, 4-5 parts of Polygala tenuifolia, 6-8 parts of Ziziphus jujuba seeds, 9-15 parts of Poria, 6-8 parts of Ophiopogon japonicus, 12-14 parts of Oyster, 9-11 parts of Semen Cassiae and 5-8 parts of Gastrodia elata.

3. The Chinese medicinal composition for treating Alzheimer's disease containing Cimicifuga according to claim 2, characterized in that: The Chinese medicine composition comprises: By weight, 7 parts of Cimicifuga, 10 parts of Ginseng, 13 parts of Astragalus, 8 parts of Salvia miltiorrhiza, 6 parts of Acorus calamus, 4 parts of Polygala tenuifolia, 7 parts of Semen Ziziphi spinulosae, 11 parts of Poria, 7 parts of Ophiopogon japonicus, 13 parts of Oyster, 10 parts of Semen Cassiae and 6 parts of Gastrodia elata.

4. The Chinese medicinal composition for treating Alzheimer's disease containing Cimicifuga according to claim 1, characterized in that: The dosage form of the Chinese medicine composition is pills, capsules or oral liquid.

5. The Chinese medicinal composition for treating Alzheimer's disease containing Cimicifuga according to claim 1, characterized in that: The preparation process of the traditional Chinese medicine composition is as follows: various raw materials are mixed in proportion and crushed into 100 meshes, and honey or starch paste is added to prepare pills.

6. The Chinese medicinal composition for treating Alzheimer's disease containing Cimicifuga according to claim 1, characterized in that: The preparation process of the traditional Chinese medicine composition is as follows: boiling and extracting each raw medicine twice with water in proportion, combining the filtrate and concentrating it into an extract, and adding a flavoring agent to prepare an oral solution.

7. The Chinese medicinal composition for treating Alzheimer's disease containing Cimicifuga according to claim 6, characterized in that: The relative density of the extract is 1.05-1.10.