A traditional Chinese medicine composition for treating senile and vascular dementia, its preparation method and application

Abstract

The present invention discloses a traditional Chinese medicine composition for treating senile and vascular dementia, its preparation method and application. The traditional Chinese medicine composition comprises the following raw materials by weight: 5-140 parts by weight of astragalus membranaceus, 5-40 parts by weight of salvia miltiorrhiza, 1-20 parts by weight of ginseng, 2-30 parts by weight of polygonatum sibiricum, 1-20 parts by weight of angelica sinensis, 3-25 parts by weight of hawthorn, 2-30 parts by weight of processed polygonum multiflorum, 2-30 parts by weight of wolfberry fruit, 1-20 parts by weight of polygala tenuifolia, 2-30 parts by weight of acorus tatarinowii, 1-20 parts by weight of pheretima. The present invention has the effects of supplementing qi and activating blood circulation, improving intelligence and strengthening the brain, and is mainly used for treating cerebrovascular dementia of qi deficiency and blood stasis type. It can improve the learning and memory abilities of senile dementia and vascular dementia, increase the cerebral blood flow of vascular dementia, reduce the cerebrovascular resistance, prolong the survival time of cerebral ischemia and hypoxia, and has obvious inhibitory effects on the increased cerebrovascular permeability caused by cerebral hypoxia and the increased brain index.

Description

Technical Field

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

[0002] At present, there is still no effective drug for treating senile dementia.

[0003] Vascular Dementia (VD) is a persistent impairment of acquired intelligence caused by cerebrovascular diseases, and belongs to the categories of "dementia", "depression", "amnesia" and other diseases in traditional Chinese medicine. Among the patients with dementia worldwide, vascular dementia accounts for 10% - 20%, and about 20% of the patients with senile dementia have both vascular dementia and Alzheimer's Disease (AD).

[0004] The etiology and pathogenesis of vascular dementia are complex, and the disease manifestations vary greatly. Modern medicine believes that cerebral infarction and cerebral ischemia are the basic etiologies of vascular dementia. In addition, the occurrence of vascular dementia is also related to factors such as hypertension, diabetes, hyperlipidemia, obesity, smoking, high-salt diet, heart disease, stroke, alcohol consumption, and psychological stress. Like other geriatric diseases, the incidence of vascular dementia doubles with age. Traditional Chinese medicine believes that the basic pathogenesis of dementia is deficiency in origin and excess in superficiality. Senile heart and spleen qi deficiency, and liver and kidney deficiency are the root causes of the disease; blood stasis and phlegm obstruction, and adverse flow of the brain collaterals are the superficial symptoms. The disease location is in the brain and is related to the zang-fu organs such as the heart, kidney, liver, and spleen. Li Shizhen said that "the brain is the residence of the original spirit". The essence blood of the five zang-organs and the clear yang qi of the six fu-organs all flow upward and are infused here. Moreover, the brain is the sea of marrow and is the basis for spiritual intelligence and memory. If the zang-fu organs are weak and the vital qi is insufficient in old age, qi fails to promote blood circulation, resulting in stasis due to deficiency, and stasis accumulates in the brain collaterals, and the brain vessels are not smooth; or due to long-term illness, the qi and blood circulation is disharmonious, and the collaterals are disordered, and then blood stasis blocks, and the brain collaterals are blocked. Stasis leads to deficiency, forming a pathological situation of deficiency and excess mixed. Then qi and blood cannot nourish the upper part, and essence and marrow are also difficult to fill the brain. As a result, mental decline and dullness occur, spiritual intelligence becomes dull and memory is lost. Therefore, speech is disordered and things are easily forgotten; since the vital qi is deficient, there is fatigue and weakness; and due to qi deficiency, blood circulation is not smooth, stasis accumulates in the collaterals, the muscles and skin are not nourished by the nutritive blood, and the meridians and collaterals are not unblocked by qi and blood. Therefore, the muscles and skin are not nourished, the limbs are numb or paralyzed. The tongue shows pale and dull color or has stasis spots, the tongue body is swollen or has tooth marks, and the pulse is deep, thready or weak, which are exactly the symptoms of spleen qi deficiency and internal blockage of blood stasis. The treatment should be to supplement the vital qi to promote blood circulation, remove blood stasis to unblock the brain collaterals, replenish essence and blood to strengthen the brain and calm the mind, and activate the heart qi to open the orifices and improve intelligence. Therefore, in the experimental study of traditional Chinese medicine in the treatment of vascular dementia, traditional Chinese medicines for promoting blood circulation, nourishing blood and supplementing qi are most commonly used in the formula, such as angelica, chuanxiong, ginseng, astragalus, etc. Their effectiveness has been repeatedly verified by experiments, which is consistent with the ultimate pathogenic factor of vascular dementia - cerebral ischemia. While increasing cerebral blood supply with traditional Chinese medicines for promoting blood circulation, nourishing blood and supplementing qi, it can remove toxic substances from neuronal lesions, such as nitric oxide, oxygen free radicals, etc., enhance the material basis of neurotransmitter metabolism and DNA synthesis metabolism, enhance the resistance of brain cells, protect brain cells, and improve brain function.

[0005] Vascular dementia is a common and frequently-occurring disease among the elderly. Therefore, with the progress of society and the continuous extension of human lifespan, the world has entered an aging society. The incidence of cerebrovascular diseases is increasing year by year, and its fatality rate and disability rate are both very high. Therefore, seeking and developing effective treatment methods for vascular dementia has become a research topic that medical experts in various countries attach great importance to.

[0006] In terms of western medicine treatment, the western medicines with relatively positive efficacy are mostly reversible acetylcholinesterase inhibitors, such as donepezil hydrochloride, piracetam, dihydroergotamine mesylate, etc., which produce therapeutic effects by inhibiting the acetylcholinesterase of the postsynaptic membrane of neurotransmission. Li Nan et al. (Chinese Journal of Clinical Rehabilitation, 2005, 9(9):168) observed the effects of donepezil hydrochloride on short-term and long-term memory and cognitive function of patients with mild and moderate vascular dementia, and observed its safety. 60 patients with mild and moderate vascular dementia were randomly divided into two groups. The treatment group was given donepezil hydrochloride tablets, and the control group was given piracetam tablets. After 8 weeks of continuous administration, the memory function, cognitive function and mental and neurological function of patients with vascular dementia in the donepezil hydrochloride tablets group were significantly improved, with a total effective rate of 93%. The score of the simple mental state assessment form was significantly improved, and the difference was very significant compared with the control group (P<0.01). It is believed that donepezil hydrochloride has good therapeutic effect, good safety and few adverse reactions for mild to moderate vascular dementia.

[0007] In terms of traditional medical treatment, after many years of research by many scholars in my country, some progress has been made, but it is still in a state of contention among a hundred schools of thought. The Anti-Aging Committee of the Internal Medicine Branch of the Chinese Association of Traditional Chinese Medicine divides the TCM syndrome differentiation of vascular dementia into seven types: kidney essence deficiency syndrome, phlegm and turbidity blocking the meridians syndrome, blood stasis blocking the collaterals syndrome, and liver yang hyperactivity syndrome. Ma Yunzhi (Henan Traditional Chinese Medicine, 2000, (4): 1-2) divides this disease into three types: kidney essence deficiency and marrow sea deficiency type, which is treated by strengthening the spleen and kidney, replenishing essence and filling marrow; qi deficiency and blood stasis, blood stasis blocking the collaterals type, which is treated by invigorating qi and activating blood circulation, strengthening the spleen and tonifying the kidney; phlegm and blood stasis interaction, endogenous turbidity and toxins type, which is treated by removing blood stasis, promoting diuresis and detoxification. Xie Yingzhen et al. proposed a staged syndrome differentiation for vascular dementia (first stage, then type), and different treatment principles are adopted for each stage; in the plateau stage (liver and kidney essence deficiency, phlegm and blood stasis blocking the collaterals, spleen and kidney deficiency, phlegm and blood stasis blocking the collaterals are common syndromes), give full play to the overall regulation of traditional Chinese medicine to delay the progression of the disease; in the fluctuating stage (liver and kidney yin deficiency, wind phlegm and blood stasis, spleen and kidney deficiency, phlegm turbidity and blood stasis, phlegm and fire disturbing the heart, heart and kidney disharmony are common syndromes); in the declining stage (wind and fire disturbing the upper body, turbidity and toxins are prosperous syndromes), take Chinese medicine emergency measures or combine Chinese and Western medicine to effectively control and prevent step-like decline. At present, the treatment of Chinese patent medicine mainly treats mild and moderate vascular dementia with kidney-tonifying and qi-invigorating, phlegm-removing and blood-activating methods.

[0008] Fan Luping et al. (Journal of Difficult and Complicated Cases, 2003, (5): 260-262) used the method of permanently ligating bilateral carotid arteries to obtain a vascular dementia rat model. With western medicine donepezil hydrochloride as a control, an experimental study on treating vascular dementia with the method of tonifying kidney and replenishing qi (red ginseng, astragalus membranaceus, fleeceflower root, wolfberry fruit, rehmannia root) and the method of promoting blood circulation to remove blood stasis (salvia miltiorrhiza, ligusticum wallichii, radix paeoniae rubra, curcuma aromatica) was compared. The results showed that both experimental groups could significantly improve the learning and memory ability of vascular dementia rats, with significant differences compared with the model group (P<0.05). However, there were no significant differences between the two traditional Chinese medicine groups and between the two traditional Chinese medicine groups and the western medicine group (P>0.05); both groups of traditional Chinese medicine could reduce the damage of ischemia to pyramidal cells in the CA1 area of the hippocampus. Among them, the group of promoting blood circulation to remove blood stasis was closer to the normal group, and there were significant differences in the number of pyramidal cells per unit area in the hippocampus compared with the group of tonifying kidney and replenishing qi and the western medicine donepezil hydrochloride group (P<0.05); it was thus speculated that the effect of treating vascular dementia with the method of promoting blood circulation to remove blood stasis might be superior to that of the method of tonifying kidney and replenishing qi and western medicine donepezil hydrochloride.

[0009] Yang Wenming et al. (Journal of Chinese Medicinal Materials Information, 2002, (12): 13 - 15) randomly divided 90 patients with vascular dementia of spleen - kidney deficiency and phlegm - stasis blocking collaterals type into 2 groups in a single - blind manner. The treatment group was treated with Zhinao Capsule (Radix Codonopsis, Rhizoma Polygonati, Rhizoma Acori Tatarinowii, Rhizoma Chuanxiong, etc.), and the control group was given Hydergine (Dihydroergotoxine Mesylate). The result showed that the total effective rate of Zhinao Capsule was 63.3%, and that of the control group was 53.3%. Zhang Boli et al. (Chinese Journal of Integrated Traditional and Western Medicine, 2002, (8): 577 - 580) used Jiannao Yizhi Granules (processed Radix Polygoni Multiflori, roasted Radix Astragali, Rhizoma Chuanxiong, Fructus Ligustri Lucidi, Cynomorium Songaricum, Semen Cuscutae, Rhizoma Acori Tatarinowii, Arisaema Cum Bile, etc.) to treat 89 cases of early mild - moderate vascular dementia by the method of tonifying the kidney and replenishing qi, resolving phlegm and activating blood circulation, reducing turbidity and resuscitating the mind, and observed them in comparison with 106 cases taking Hydergine (Dihydroergotoxine Mesylate) orally and 47 cases taking placebo orally. The result showed that the effective rates of the traditional Chinese medicine group, western medicine group, and placebo group were 58.4%, 48.1%, and 23.4% respectively. After Ridit analysis, the curative effect of the traditional Chinese medicine treatment group was better than that of the control group (P < 0.05, P < 0.01); Zhang Min et al. (Shaanxi Journal of Traditional Chinese Medicine, 2001, (2): 85) used modified Liuwei Dihuang Decoction (Rehmannia Glutinosa, Dioscorea Opposita, Cornus Officinalis, Poria Cocos, Radix Astragali, Rhizoma Acori Tatarinowii, Hirudo, etc.) to treat 36 cases of vascular dementia by the method of nourishing the liver and kidney, strengthening the brain and improving intelligence, removing stasis and promoting blood circulation. The result showed that the total effective rate was 80.6%. Ji Hong et al. (Shanxi Journal of Traditional Chinese Medicine, 2000, (2): 10 - 11) used Danggui Shaoyao Powder (Angelica Sinensis, Paeonia Lactiflora, Rhizoma Chuanxiong, Poria Cocos, Atractylodes Macrocephala, Alisma Orientalis) to treat 37 cases of vascular dementia of liver - kidney deficiency and blood - stasis blocking collaterals type by the method of promoting blood circulation to remove stasis and dredge collaterals, promoting diuresis and resolving phlegm, and compared them with 31 cases treated with Piracetam. The result showed that the total effective rates were 86.49% and 58.05% respectively (P < 0.01%). For the Mini - Mental State Examination (MMSE) and Hasegawa Dementia Scale (HDS) scores, the improvement was better than that of the control group (P < 0.01), and the improvement of hemorheological indexes was also better than that of the control group (P > 0.05). Li Xiaojun et al. (Shanxi Journal of Traditional Chinese Medicine, 2001, (3): 26) used Yiqi Congming Decoction (Radix Astragali, Radix Codonopsis, Radix Glycyrrhizae Preparata, Rhizoma Cimicifugae, Radix Puerariae, Vitex Trifolia, Paeonia Lactiflora, Cortex Phellodendri) to treat 34 cases of vascular dementia by the method of supplementing qi and ascending yang, soothing the liver and reducing turbidity. The result showed that 6 cases were markedly effective, 22 cases were effective, and 6 cases were ineffective, and the total effective rate was 82.4%.

[0010] Chinese Patent with Publication No. CN115105568 discloses a preparation method and use of Shenwu Jiannao Capsules for preventing and / or treating Alzheimer's disease. The prescription raw materials of the Shenwu Jiannao Capsules are ginseng, processed Polygonum multiflorum, Codonopsis pilosula, Astragalus membranaceus, Rehmannia glutinosa, Chinese yam, Salvia miltiorrhiza, Lycium barbarum, Paeonia lactiflora, Polygala tenuifolia, Poria cum Radix Pini, Acorus tatarinowii, Scutellaria baicalensis, Pueraria lobata, Pueraria thomsonii, Ziziphus jujuba var. spinosa, Ophiopogon japonicus, Dragon bone (powder), Cyperus rotundus, Chrysanthemum morifolium, Lecithin and Vitamin E. This patent is a combination of traditional Chinese and Western medicines without the guidance of traditional Chinese medicine theory and insufficient basis for syndrome differentiation in traditional Chinese medicine prescription. The Notice of the National Medical Products Administration on Issuing the "Classification and Requirements for Application Materials of Traditional Chinese Medicines" (No. 68 in 2020) has no such category of innovative drugs since September 27, 2020. And this medicine is for preventing / treating AD and cannot be used to treat vascular dementia. Summary of the Invention

[0011] The present invention aims to provide a traditional Chinese medicine composition for treating senile and vascular dementia, its preparation method and application, with better curative effect and fewer side effects in treating senile and vascular dementia.

[0012] To achieve the above object, the technical solution adopted by the present invention is:

[0013] A traditional Chinese medicine composition for treating senile and vascular dementia, comprising the following raw materials in parts by weight: 5-140 parts by weight of Astragalus membranaceus, 5-40 parts by weight of Salvia miltiorrhiza, 1-20 parts by weight of Ginseng, 2-30 parts by weight of Polygonatum sibiricum, 1-20 parts by weight of Angelica sinensis, 3-25 parts by weight of Hawthorn, 2-30 parts by weight of processed Polygonum multiflorum, 2-30 parts by weight of Lycium barbarum, 1-20 parts by weight of Polygala tenuifolia, 2-30 parts by weight of Acorus tatarinowii, 1-20 parts by weight of Pheretima aspergillum.

[0014] Preferably, Astragalus and Salvia miltiorrhiza are the main drugs. Traditional Chinese medicine believes that the basic pathogenesis of dementia is deficiency of the root and excess of the symptoms. The deficiency of the spleen and the liver and kidney in old age are the root of the disease; blood stasis and phlegm obstruction, and poor brain circulation are the symptoms of the disease. The disease is located in the brain and is related to the heart, kidney, liver, spleen and other internal organs. Li Shizhen said that "the brain is the home of the primordial spirit", and the blood of the five internal organs and the clear yang qi of the six internal organs are all injected here. Moreover, the brain is the sea of ​​marrow, which is the basis of the brain's intelligence and memory. If one is old and his internal organs are weak and his vital energy is insufficient, the qi fails to promote blood circulation, and the deficiency leads to blood stasis, which stagnates in the brain meridians and makes the brain vessels obstructed; or if one has been ill for a long time, the qi and blood circulation is out of harmony, the meridians are out of regulation, and then blood stasis is blocked, the brain meridians are blocked, and the blood stasis leads to deficiency, forming a pathological situation of mixed deficiency and excess, then the qi and blood cannot nourish the upper body, and the essence can hardly replenish the brain, so the mind declines and the face becomes dull, the inspiration is dull and the memory is lost, so the speech is incoherent and the person is forgetful; the vital energy is deficient, so one feels tired and weak; and the qi is deficient and the blood stagnates in the meridians, the skin loses the moisture of the nourishing blood, and the meridians lose the flow of qi and blood, so the skin is not nourished and the limbs are numb or paralyzed. The formula uses Astragalus and Salvia miltiorrhiza as the main ingredients. Astragalus is sweet and warm, which can greatly replenish vital energy, strengthen the spleen and help blood circulation; Salvia miltiorrhiza is bitter and slightly warm, which can specifically enter the blood, resolve blood stasis and unclog the meridians. The combination of these two herbs can invigorate Qi and activate blood circulation, resolve blood stasis in the brain and unblock the meridians, so that Qi, blood and essence can all flow upward to nourish the brain.

[0015] The medicine of the present invention selects eleven medicinal ingredients, including astragalus, salvia miltiorrhiza, ginseng, polygonatum, angelica, hawthorn, processed polygonum multiflorum, wolfberry, polygala, calamus and earthworm, which have the effects of invigorating qi and activating blood circulation, improving intelligence and strengthening the brain. Astragalus and salvia miltiorrhiza are used as the main ingredients in the prescription. The sweet and warm taste of astragalus can greatly invigorate the vital energy, strengthen the spleen and help the blood circulation; salvia miltiorrhiza is bitter and slightly warm in taste, specifically enters the blood, resolves blood stasis and unclogs the meridians. The two medicines are matched to invigorate qi and activate blood circulation, resolve blood stasis in the brain and unblock the meridians, so that qi, blood and essence can all go up to nourish the brain. It is assisted with Polygonatum sibiricum and ginseng to replenish vital energy. Among them, Polygonatum sibiricum is sweet and mild, beneficial to both Qi and yin, and has the function of "replenishing marrow and filling essence", thus having biochemical activity. Ginseng is sweet and warm, can replenish the five internal organs, calm the spirit, make people happy and improve intelligence. When used together with Astragalus membranaceus, it can greatly replenish vital energy, and when Qi is strong, blood will flow. Angelica sinensis and hawthorn are used to promote blood circulation and disperse blood stasis. Among them, Angelica sinensis is pungent, sweet and warm, nourishes blood and promotes blood circulation, and is the main medicine for treating blood diseases. Hawthorn is sour, sweet and warm, promotes qi and disperses blood stasis, removes blood stasis and eliminates stagnation. When used together with Salvia miltiorrhiza, it is good at entering the blood, resolving blood stasis and unblocking collaterals. The above four flavors are collectively ministerial drugs. With processed Polygonum multiflorum and Lycium barbarum, it nourishes the liver and kidney, improves the essence and blood, makes the essence and blood sufficient and the spirit can be nourished, then the mind is enhanced and the memory is based on; with Polygala tenuifolia and Acorus calamus, it can open the heart qi to improve the intelligence, benefit the clear orifices and improve the spirit, and Polygala tenuifolia is bitter and pungent in nature, calms the mind and calms the nerves, removes phlegm and opens the orifices, and Acorus calamus and ginseng can wake up the mind, open the orifices and improve the mind, and treat forgetfulness and speech inversion. The four flavors are adjuvants. With earthworm, it is salty and cold and good at unblocking the collaterals, activating the meridians, and can lead various blood-activating drugs to enter the collaterals and dissolve blood stasis. Its descending nature has the wonderful effect of leading blood stasis downward, and it is used as an assistant. The whole prescription has an orderly monarch and minister, and a moderate assistant and envoy. It is warm but not dry, nourishing but not greasy, nourishing without leaving evil, removing blood stasis without hurting the body, treating both the symptoms and the root causes, strengthening the body and eliminating evil, and playing the role of invigorating qi and activating blood, strengthening the brain and improving intelligence.

[0016] The four herbs of Polygonatum, Angelica, Crataegus pinnatifida, and Pheretima are mainly used to activate the biochemical activity of Qi and blood and enhance the power. Without Polygonatum, the essence and Qi will have no source for biochemical activity; without Angelica, which is the key medicine for ischemic diseases, the blood will have no source for nourishing blood; without Crataegus pinnatifida, the blood stasis will be insufficient; without Pheretima, it will be difficult to enter the meridians. The 11 herbs in this prescription are derived from the understanding of Chinese medicine classics and the summary of long-term clinical practice experience, so this prescription has special effects in the clinical treatment of senile and vascular dementia.

[0017] According to the embodiments of the present invention, the present invention can be further optimized. The following is the technical solution formed after optimization:

[0018] In one preferred embodiment, the Chinese medicine composition for treating senile and vascular dementia further comprises the following raw materials in weight: 0.5-40 weight parts of Poria cocos. Poria cocos has the function of calming the mind and tranquilizing the spirit, and there is a saying that "nine out of ten are Poria cocos", especially the one with pine wood in the middle part of Poria cocos, which is called "Fu Shen", and is mainly used to treat palpitations, insomnia, forgetfulness and other symptoms, and is very beneficial to improving the sleep quality of patients with senile and vascular dementia.

[0019] Preferably, the Chinese medicine composition for treating senile and vascular dementia further comprises the following raw materials in parts by weight: 20-40 parts by weight of Poria cocos.

[0020] In one of the preferred embodiments, the Chinese medicine composition for treating senile and vascular dementia comprises the following raw materials in parts by weight: 8-130 parts by weight of Astragalus, 8-30 parts by weight of Salvia miltiorrhiza, 2-15 parts by weight of Ginseng, 4-20 parts by weight of Polygonatum, 2-15 parts by weight of Angelica sinensis, 4-18 parts by weight of Crataegus, 4-20 parts by weight of Processed Polygonum multiflorum, 4-20 parts by weight of Lycium barbarum, 2-15 parts by weight of Polygala tenuifolia, 4-20 parts by weight of Acorus calamus, and 2-15 parts by weight of Pheretima.

[0021] In one of the preferred embodiments, the Chinese medicine composition for treating senile and vascular dementia comprises the following raw materials in parts by weight: 10-120 parts by weight of Astragalus, 10-25 parts by weight of Salvia miltiorrhiza, 3-10 parts by weight of Ginseng, 6-15 parts by weight of Polygonatum, 3-10 parts by weight of Angelica sinensis, 5-12 parts by weight of Crataegus, 6-15 parts by weight of Processed Polygonum multiflorum, 6-15 parts by weight of Lycium barbarum, 3-10 parts by weight of Polygala tenuifolia, 6-15 parts by weight of Acorus calamus, and 3-10 parts by weight of Pheretima.

[0022] In one of the preferred embodiments, the Chinese medicine composition for treating senile and vascular dementia comprises the following raw materials in parts by weight: 10-30 parts by weight of Astragalus, 10-25 parts by weight of Salvia miltiorrhiza, 3-10 parts by weight of Ginseng, 6-15 parts by weight of Polygonatum, 3-10 parts by weight of Angelica sinensis, 5-12 parts by weight of Crataegus, 6-15 parts by weight of Processed Polygonum multiflorum, 6-15 parts by weight of Lycium barbarum, 3-10 parts by weight of Polygala tenuifolia, 6-15 parts by weight of Acorus calamus, and 3-10 parts by weight of Pheretima.

[0023] Further preferably, a traditional Chinese medicine composition for treating senile and vascular dementia comprises the following raw materials by weight: 20 parts by weight of astragalus membranaceus, 20 parts by weight of salvia miltiorrhiza, 5 parts by weight of ginseng, 10 parts by weight of polygonatum sibiricum, 5 parts by weight of angelica sinensis, 7.5 parts by weight of hawthorn fruit, 10 parts by weight of processed polygonum multiflorum, 10 parts by weight of wolfberry fruit, 5 parts by weight of polygala tenuifolia, 10 parts by weight of acorus tatarinowii, and 5 parts by weight of pheretima aspergillum.

[0024] The present invention also discloses a preparation method of the traditional Chinese medicine composition for treating senile and vascular dementia, comprising the following steps:

[0025] Add water to acorus tatarinowii and angelica sinensis, extract volatile oil and aromatic water by steam distillation method, add a clathrating agent to clathrate the volatile oil, stir, refrigerate, and filter to obtain a clathrate, residue I and liquid medicine I, and dry the clathrate;

[0026] Take salvia miltiorrhiza and ginseng, extract with a solvent, combine the filtrates, and concentrate under reduced pressure to recover the solvent to obtain residue II and extract II;

[0027] Take astragalus membranaceus, polygonatum sibiricum, hawthorn fruit, processed polygonum multiflorum, wolfberry fruit, polygala tenuifolia, and pheretima aspergillum, mix with residue I and residue II, extract with water, combine the filtrate with liquid medicine I, and concentrate under reduced pressure to obtain extract III for standby;

[0028] Combine extract II and extract III, dry, and add the prepared clathrate to obtain a drug extract.

[0029] In the prescription, acorus tatarinowii and angelica sinensis contain volatile components, which are one of the active substances for treating senile and vascular dementia. If decocted together, there will be great loss. Therefore, they are extracted separately, and the volatile oil is protected and clathrated, and added during the final granule mixing.

[0030] In the prescription, salvia miltiorrhiza and ginseng contain both liposoluble and water-soluble active ingredients. The main chemical components of salvia miltiorrhiza are two categories: liposoluble diterpenoid compounds and water-soluble polyphenolic acid components; liposoluble components include tanshinone I, tanshinone IIA, cryptotanshinone, etc.; water-soluble components include danshensu, salvianic acid A, salvianic acid B, salvianic acid C, protocatechuic acid, protocatechualdehyde, etc. In particular, the liposoluble components of salvia miltiorrhiza with blood-activating effect are difficult to extract during boiling and are prone to oxidation. Therefore, in this prescription, they should be extracted separately from the water-soluble components. The alcohol-soluble component ginsenoside in ginseng, which has the function of promoting qi flow for treating vascular dementia, is also extracted by alcohol together with salvia miltiorrhiza first.

[0031] The effective active ingredients contained in the remaining medicinal flavors are mostly water-soluble components, so water extraction is used. At the same time, the residues of the first four medicinal materials also contain some water-soluble active ingredients, which are jointly involved in the water extraction process.

[0032] In one preferred embodiment, the traditional Chinese medicine composition further comprises 0.5 - 40 parts by weight of Poria cocos. The paste II and paste III are combined, dried, and then fine powder of Poria cocos and the clathrate are added to obtain the drug extract.

[0033] Therefore, this process and preparation have the following innovations:

[0034] (1) Comprehensive extraction and retention of the components in the prescription of traditional Chinese medicine flavors for treating vascular dementia;

[0035] (2) Separately collect the volatile oils of Acorus tatarinowii and Angelica sinensis, and use the clathration method to protect their stability; add them during the final granulation to increase the uniformity of the volatile components in the preparation, thereby ensuring the effectiveness of the product.

[0036] (3) First, use alcohol extraction for the alcohol-soluble components of invigorating qi and promoting blood circulation in the prescription (ginsenosides in ginseng and tanshinones in Salvia miltiorrhiza), and then use water extraction for the water-soluble active components (ginseng polysaccharides, salvianolic acid B, etc.) in the medicinal residues and the remaining medicinal materials, so as to achieve the full utilization of all components.

[0037] (4) The preparation preferably uses a granule with strong compatibility, which can be consistent with the traditional decoction and can accommodate all the extracted components, ensuring the clinical compliance of the drug.

[0038] Preferably, the clathrant is β - cyclodextrin.

[0039] Preferably, after extracting Acorus tatarinowii and Angelica sinensis by steam distillation method and adding β - cyclodextrin for clathration, the drying temperature is 40 - 60 °C.

[0040] Preferably, when Astragalus membranaceus, Polygonatum sibiricum, Crataegus pinnatifida, Polygonum multiflorum Thunb. var. multiflorum, Lycium barbarum, Polygala tenuifolia, and Pheretima are extracted with water, medicinal residue I and medicinal residue II are added simultaneously.

[0041] Preferably, Astragalus membranaceus, Polygonatum sibiricum, Crataegus pinnatifida, Polygonum multiflorum Thunb. var. multiflorum, Lycium barbarum, Polygala tenuifolia, and Pheretima are extracted with water 1 - 5 times, with 5 - 12 times the amount of water added each time, and the extraction time is 0.5 - 3 hours.

[0042] Preferably, paste II and paste III are prepared by spray drying.

[0043] Preferably, the temperature of vacuum concentration is 55 - 65 °C.

[0044] In one preferred embodiment, 5 - 10 times the volume of water is added to Acorus tatarinowii and Angelica sinensis.

[0045] In one preferred embodiment, the solvent for extracting Salvia miltiorrhiza and ginseng is ethanol with a volume percentage concentration of 50 - 95%, the extraction times are 1 - 3 times, 4 - 12 times the volume of ethanol is added each time, and the extraction time is 1 - 3 hours. This can not only extract tanshinones and ginsenosides with good alcohol solubility but also ensure their stability, and take into account the energy consumption of large-scale industrial production.

[0046] In one preferred embodiment, the extract II is a clear extract with a relative density of 1.10 - 1.20 or a thick extract with a relative density of 1.20 - 1.40 at 55 - 65°C;

[0047] The extract III is a clear extract with a relative density of 1.10 - 1.20 or a thick extract with a relative density of 1.20 - 1.40 at 55 - 65°C. The corresponding density in the extract concentration is beneficial to ensuring the convenience and stability of the transfer and storage of the intermediate, as well as the convenience of the preparation.

[0048] Preferably, the prepared medicinal extract is added with excipients to prepare common oral preparations.

[0049] Preferably, 0.5 - 5% of colloidal silica and dextrin are added to the prepared medicinal extract, mixed evenly, granulated with 70% - 90% ethanol, and dried to obtain granules. Tablets, capsules, decoction extracts, liquid extracts, extracts, syrups, oral liquids, pills or powders can also be prepared according to the requirements of the dosage form.

[0050] The present invention also discloses the use of the traditional Chinese medicine composition for treating senile and vascular dementia and the traditional Chinese medicine composition prepared by the preparation method in the preparation of drugs for treating senile and vascular dementia.

[0051] In one preferred embodiment, the preparations of the traditional Chinese medicine composition for treating senile and vascular dementia include granules, tablets, capsules, decoction extracts, liquid extracts, extracts, syrups, oral liquids, pills, powders.

[0052] Thus, the prescription of the present invention is based on the Dingzhi Pills (ginseng, polygala tenuifolia, poria cocos, acorus tatarinowii) for treating amnesia in "Emergency Prescriptions Worth a Thousand Gold" by Sun Simiao in the Tang Dynasty and the Buyang Huanwu Decoction (astragalus membranaceus, red peony root, ligusticum wallichii, angelica sinensis, earthworm, peach kernel, safflower) for supplementing qi and activating blood circulation in "Correcting Errors in Medical Understanding" by Wang Qingren in the Qing Dynasty. Combining the medication experience in the clinical treatment of cerebrovascular dementia, it is modified by addition and subtraction, overcoming the insufficient blood circulation of using Dingzhi Pills alone and the insufficient resuscitation of using Buyang Huanwu Decoction alone. This formula has the effects of supplementing qi and activating blood circulation, strengthening the brain and improving intelligence, and is used to treat cerebrovascular dementia of qi deficiency and blood stasis type. This formula has been used in the Affiliated Hospital of Hunan College of Traditional Chinese Medicine for the systematic treatment of vascular dementia. The total effective rate of Jiannao Granules for the treatment of vascular dementia is 70.0%, and the total effective rate for the improvement of traditional Chinese medicine dementia symptoms is 93.55%. Taking the symptoms of traditional Chinese medicine dementia such as amnesia, slow reaction, speech impairment, dizziness, irritability, fatigue, and dull tongue as the main symptoms, and taking the living ability such as self-care and the degree of resuming general social activities as the observation indicators, Jiannao Granules have a significant improvement effect on the cognitive function symptoms of cerebrovascular dementia of qi deficiency and blood stasis type, and also have obvious improvements on the behavioral function, syndromes and symptoms of qi deficiency and blood stasis syndrome of patients. This application is made into granules, and further stratified block random, double-blind controlled, multi-center phase II and III clinical trials of 900 cases are carried out in 16 top-three traditional Chinese medicine hospitals led by Xiyuan Hospital of China Academy of Chinese Medical Sciences. The results show that this product is clinically judged effective in the treatment of cerebrovascular dementia of qi deficiency and blood stasis type.

[0053] Traditional Chinese medicine has included 13 prescriptions in "Huangdi Neijing", 328 prescriptions in "Treatise on Febrile Diseases" and "Treatise on Febrile and Miscellaneous Diseases" by Zhang Zhongjing, and nearly 100,000 prescriptions are included in "Dictionary of Traditional Chinese Medicine Prescriptions". The number of prescriptions has increased infinitely, but the key is that the prescription should be guided by traditional Chinese medicine theory and have good clinical effects to solve world problems, such as the problem that there is currently no effective drug for the treatment of vascular dementia in the world.

[0054] Compared with the prior art, the beneficial effects of the present invention are as follows: The formula (prescription) of the present invention and the preparations formed therefrom have the effects of supplementing qi and activating blood circulation, improving intelligence and strengthening the brain, and are used to treat cerebrovascular dementia of qi deficiency and blood stasis type. It can improve the learning and memory abilities of senile dementia and vascular dementia, increase the cerebral blood flow of vascular dementia, reduce the cerebrovascular resistance, prolong the survival time of cerebral ischemia and hypoxia, and have obvious inhibitory effects on the increased cerebrovascular permeability and increased brain index caused by cerebral hypoxia. It is used for the treatment of senile dementia or cerebrovascular dementia and the adjuvant treatment of other cerebrovascular diseases, and is safe to use. At the same time, the present invention also discloses the preparation method of the pharmaceutical composition and its preparations, and this method has strong feasibility and is easy for industrial production. Detailed implementation manners

[0055] The drugs of the present invention can be prepared through the following implementation manners. The following specific examples are explanations of the present invention and cannot limit the present invention.

[0056] The preparation method of the traditional Chinese medicine composition of the present invention is as follows:

[0057] Take Acorus tatarinowii and Angelica sinensis, add 6 times the amount of water, and extract volatile oil and aromatic water by steam distillation method. Add β-cyclodextrin and grind for inclusion, stir, refrigerate, filter to obtain the inclusion compound, and dry it at low temperature for standby; keep the medicinal residues and the medicinal liquid for later use;

[0058] Take Salvia miltiorrhiza and Panax ginseng, extract twice with 90% ethanol. For the first time, add 10 times the amount of alcohol and extract for 2 hours. For the second time, add 8 times the amount of alcohol and extract for 1.5 hours. Combine the filtrates, recover ethanol under reduced pressure, and then concentrate under reduced pressure to obtain a clear extract with a relative density of 1.12 - 1.18 at 60°C or concentrate under reduced pressure to a thick extract with a relative density of 1.30 - 1.35 at 60°C for standby; keep the medicinal residues for later use;

[0059] Take Astragalus membranaceus, Polygonatum sibiricum, Crataegus pinnatifida, Polygonum multiflorum Thunb. var. thomsonii, Lycium barbarum, Polygala tenuifolia, and Pheretima, mix them with the medicinal residues of the above four herbs, extract twice with water. For the first time, add 10 times the amount of water and extract for 1.0 hour. For the second time, add 8 times the amount of water and extract for 1.0 hour. Combine the filtrates with the medicinal liquid when extracting volatile oil, and concentrate under reduced pressure to obtain a clear extract with a relative density of 1.12 - 1.18 at 60°C or concentrate under reduced pressure to a thick extract with a relative density of 1.30 - 1.35 at 60°C for standby;

[0060] Combine the above clear extracts, spray dry to obtain dry extract powder, add the above volatile oil inclusion compound to obtain the drug extract; or combine the above thick extracts, dry, pulverize, and add the above volatile oil inclusion compound to obtain the drug extract.

[0061] Add 1 - 5% of microcrystalline silicon dioxide and an appropriate amount of dextrin to the prepared drug extract, mix evenly, granulate with 70% - 90% ethanol, dry to obtain granules.

[0062] The preparation and formulation of the active ingredients of the composition of the present invention can adopt the following methods: water extraction method, water extraction and alcohol precipitation method, extraction method, maceration method, percolation method, reflux extraction method, continuous reflux extraction method, ultrasonic extraction method, microwave extraction method, macroporous resin adsorption method. For example, these raw materials can be ground into powder, mixed evenly and made into powder for oral administration; these drugs can also be decocted together with water, and then the decoction liquid is concentrated to make various oral preparations; however, in order to enable the raw materials of this drug to better exert their medicinal effects, the present invention preferably adopts the following process for extracting the raw materials to make granules, but this does not limit the protection scope of the present invention.

[0063] The above components can be increased or decreased in corresponding proportions during production. For large-scale production, it can be in kilograms or tons, and for small-scale production, it can also be in grams. The weight can be increased or decreased, but the weight ratio of the crude drug materials between the components remains unchanged. After the above various extractions and refinements, for the convenience of clinical application, the finally obtained fine drug powder can be added with corresponding excipients to prepare the required dosage forms, including common oral preparations such as granules, tablets, capsules, decoction extracts, fluid extracts, extracts, syrups, oral liquids, pills, etc. These preparations should also be within the scope of protection of the present invention.

[0064] Example 1: Preparation of granules

[0065] A traditional Chinese medicine composition for treating senile and vascular dementia, comprising the following raw materials in parts by weight: 20 parts by weight of Astragalus membranaceus, 20 parts by weight of Salvia miltiorrhiza, 5 parts by weight of Panax ginseng, 10 parts by weight of Polygonatum sibiricum, 5 parts by weight of Angelica sinensis, 7.5 parts by weight of Crataegus pinnatifida, 10 parts by weight of processed Polygonum multiflorum, 10 parts by weight of Lycium barbarum, 5 parts by weight of Polygala tenuifolia, 10 parts by weight of Acorus tatarinowii, 5 parts by weight of Pheretima aspergillum.

[0066] Take Acorus tatarinowii and Angelica sinensis, add 6 times the amount of water, extract volatile oil and aromatic water by steam distillation method, add β-cyclodextrin and grind for inclusion, stir, refrigerate, filter to obtain the inclusion compound, and dry at a low temperature within 50 °C for later use; keep the medicinal residues and the medicinal liquid for later use;

[0067] Take Salvia miltiorrhiza and Panax ginseng, extract twice with 90% ethanol. For the first time, add 10 times the amount of ethanol and extract for 2 hours. For the second time, add 8 times the amount of ethanol and extract for 1.5 hours. Filter and combine the liquid, recover ethanol under reduced pressure, and then concentrate under reduced pressure to obtain a clear extract with a relative density of 1.12 - 1.18 at 60 °C or concentrate under reduced pressure to a thick extract with a relative density of 1.30 - 1.35 at 60 °C for later use; keep the medicinal residues for later use;

[0068] Take Astragalus membranaceus, Polygonatum sibiricum, Crataegus pinnatifida, processed Polygonum multiflorum, Lycium barbarum, Polygala tenuifolia, and Pheretima aspergillum, mix with the medicinal residues of the above four herbs, extract twice with water. For the first time, add 10 times the amount of water and extract for 1.0 hour. For the second time, add 8 times the amount of water and extract for 1.0 hour. Combine the filtrate with the medicinal liquid during the extraction of volatile oil, and concentrate under reduced pressure to obtain a clear extract with a relative density of 1.12 - 1.18 at 60 °C or concentrate under reduced pressure to a thick extract with a relative density of 1.30 - 1.35 at 60 °C for later use;

[0069] Combine the above clear extracts, spray dry to obtain dry extract powder, add the above volatile oil inclusion compound to obtain the drug extract; or combine the above thick extracts, dry, pulverize, and add the above volatile oil inclusion compound to obtain the drug extract.

[0070] Add 1 - 5% of microcrystalline silica and 5 - 30% of dextrin based on the total amount of the obtained drug extract, mix evenly, granulate with 70% - 90% ethanol, dry, and prepare the granules.

[0071] Example 2: Preparation of Capsules

[0072] A traditional Chinese medicine composition for treating senile and vascular dementia, comprising the following raw materials in parts by weight: 20 parts by weight of Astragalus membranaceus, 20 parts by weight of Salvia miltiorrhiza, 5 parts by weight of Panax ginseng, 10 parts by weight of Polygonatum sibiricum, 5 parts by weight of Angelica sinensis, 7.5 parts by weight of Crataegus pinnatifida, 10 parts by weight of processed Polygonum multiflorum, 10 parts by weight of Lycium barbarum, 5 parts by weight of Polygala tenuifolia, 10 parts by weight of Acorus tatarinowii, 5 parts by weight of Pheretima aspergillum, and 3 parts by weight of Poria cocos.

[0073] Take Acorus tatarinowii and Angelica sinensis, add 6 times the amount of water, extract volatile oil and aromatic water by steam distillation method, add β-cyclodextrin and grind for inclusion, stir, refrigerate, filter to obtain the inclusion compound, and dry it at low temperature for standby; retain the medicinal residues and the medicinal liquid;

[0074] Take Salvia miltiorrhiza and Panax ginseng, extract twice with 90% ethanol. For the first time, add 10 times the amount of ethanol and extract for 2 hours. For the second time, add 8 times the amount of ethanol and extract for 1.5 hours. Filter and combine the liquid, recover ethanol under reduced pressure, and then concentrate under reduced pressure to obtain a clear extract with a relative density of 1.12 - 1.18 at 60°C or concentrate under reduced pressure to obtain a thick extract with a relative density of 1.30 - 1.35 at 60°C for standby; retain the medicinal residues;

[0075] Take Astragalus membranaceus, Polygonatum sibiricum, Crataegus pinnatifida, processed Polygonum multiflorum, Lycium barbarum, Polygala tenuifolia, and Pheretima aspergillum, mix them with the medicinal residues of the above four herbs, extract twice with water. For the first time, add 10 times the amount of water and extract for 1.0 hour. For the second time, add 8 times the amount of water and extract for 1.0 hour. Combine the filtrate with the medicinal liquid during the extraction of volatile oil, and concentrate under reduced pressure to obtain a clear extract with a relative density of 1.12 - 1.18 at 60°C or concentrate under reduced pressure to obtain a thick extract with a relative density of 1.30 - 1.35 at 60°C for standby;

[0076] Combine the above clear extracts, spray dry to obtain dry extract powder, add the above volatile oil inclusion compound to obtain the drug extract; or combine the above thick extracts, dry, pulverize, and add the above volatile oil inclusion compound to obtain the drug extract.

[0077] Add 1 - 5% of microcrystalline silica and fine powder of Poria cocos to the prepared drug extract, mix evenly, granulate with 70% - 90% ethanol, dry, prepare granules, and fill them into capsules.

[0078] Example 3: Preparation of Tablets

[0079] A traditional Chinese medicine composition for treating senile and vascular dementia, comprising the following raw materials in parts by weight: 20 parts by weight of Astragalus membranaceus, 20 parts by weight of Salvia miltiorrhiza, 5 parts by weight of Panax ginseng, 10 parts by weight of Polygonatum sibiricum, 5 parts by weight of Angelica sinensis, 7.5 parts by weight of Crataegus pinnatifida, 10 parts by weight of processed Polygonum multiflorum, 10 parts by weight of Lycium barbarum, 5 parts by weight of Polygala tenuifolia, 10 parts by weight of Acorus tatarinowii, 5 parts by weight of Pheretima aspergillum. Take Acorus tatarinowii and Angelica sinensis, add 6 times the amount of water, extract volatile oil and aromatic water by steam distillation method, add β-cyclodextrin, grind and include it, stir, refrigerate, filter to obtain the inclusion compound, and dry it at low temperature for standby; retain the medicinal residues and the medicinal liquid;

[0080] Take Salvia miltiorrhiza and Panax ginseng, extract twice with 90% ethanol. For the first time, add 10 times the amount of ethanol and extract for 2 hours. For the second time, add 8 times the amount of ethanol and extract for 1.5 hours. Filter and combine the liquid, recover ethanol under reduced pressure, and then concentrate under reduced pressure to obtain a clear paste with a relative density of 1.12 - 1.18 at 60°C or concentrate under reduced pressure to a thick paste with a relative density of 1.30 - 1.35 at 60°C for standby; retain the medicinal residues;

[0081] Take Astragalus membranaceus, Polygonatum sibiricum, Crataegus pinnatifida, processed Polygonum multiflorum, Lycium barbarum, Polygala tenuifolia, Pheretima aspergillum, and mix them with the medicinal residues of the above four herbs, extract twice with water. For the first time, add 10 times the amount of water and extract for 1.0 hour. For the second time, add 8 times the amount of water and extract for 1.0 hour. Combine the filtrate with the medicinal liquid during the extraction of volatile oil, concentrate under reduced pressure to obtain a clear paste with a relative density of 1.12 - 1.18 at 60°C or concentrate under reduced pressure to a thick paste with a relative density of 1.30 - 1.35 at 60°C for standby;

[0082] Combine the above clear pastes, spray dry to obtain dry extract powder, add the above volatile oil inclusion compound to obtain the drug extract; or combine the above thick pastes, dry, pulverize, add the above volatile oil inclusion compound to obtain the drug extract.

[0083] Add 1 - 5% of microcrystalline silicon dioxide to the prepared drug extract, mix evenly, granulate with 70% - 90% ethanol, dry, make into granules, and press into tablets.

[0084] Example 4: Liquid Extract and Extract

[0085] A traditional Chinese medicine composition for treating senile and vascular dementia, comprising the following raw materials in parts by weight: 120 parts by weight of Astragalus membranaceus, 20 parts by weight of Salvia miltiorrhiza, 10 parts by weight of Panax ginseng, 20 parts by weight of Polygonatum sibiricum, 5 parts by weight of Angelica sinensis, 10 parts by weight of Crataegus pinnatifida, 10 parts by weight of processed Polygonum multiflorum, 15 parts by weight of Lycium barbarum, 5 parts by weight of Polygala tenuifolia, 10 parts by weight of Acorus tatarinowii, 5 parts by weight of Pheretima aspergillum, 20 parts by weight of Poria cocos.

[0086] Take Acorus tatarinowii and Angelica sinensis, add 6 times the amount of water, extract volatile oil and aromatic water by steam distillation method, add β-cyclodextrin, grind and include it, stir, refrigerate, filter to obtain the inclusion compound, and dry it at low temperature for standby; retain the medicinal residues and the medicinal liquid;

[0087] Take Salvia miltiorrhiza and Ginseng, extract twice with 90% ethanol. For the first extraction, add 10 times the amount of ethanol and extract for 2 hours. For the second extraction, add 8 times the amount of ethanol and extract for 1.5 hours. Filter and combine the extracts, recover ethanol under reduced pressure, and then concentrate under reduced pressure to obtain a clear extract with a relative density of 1.12 - 1.18 at 60°C or concentrate under reduced pressure to obtain a thick extract with a relative density of 1.30 - 1.35 at 60°C for later use; keep the medicinal residues for later use;

[0088] Take Astragalus membranaceus, Polygonatum sibiricum, Crataegus pinnatifida, Polygonum multiflorum Thunb. var. thomsonii, Lycium barbarum, Polygala tenuifolia, Pheretima aspergillum, Poria cocos, and mix them with the medicinal residues of the above four herbs. Extract twice with water. For the first extraction, add 10 times the amount of water and extract for 1.0 hour. For the second extraction, add 8 times the amount of water and extract for 1.0 hour. Combine the filtrate with the medicinal liquid during the extraction of volatile oil, and concentrate under reduced pressure to obtain a clear extract with a relative density of 1.12 - 1.18 at 60°C or concentrate under reduced pressure to obtain a thick extract with a relative density of 1.30 - 1.35 at 60°C for later use;

[0089] Combine the above clear extract or thick extract, add the above volatile oil inclusion compound, and mix well to obtain a fluid extract and an extract.

[0090] Example 5: Syrup

[0091] A traditional Chinese medicine composition for treating senile and vascular dementia, comprising the following raw materials in parts by weight: 50 parts by weight of Astragalus membranaceus, 30 parts by weight of Salvia miltiorrhiza, 10 parts by weight of Ginseng, 10 parts by weight of Polygonatum sibiricum, 5 parts by weight of Angelica sinensis, 10 parts by weight of Crataegus pinnatifida, 10 parts by weight of Polygonum multiflorum Thunb. var. thomsonii, 10 parts by weight of Lycium barbarum, 5 parts by weight of Polygala tenuifolia, 10 parts by weight of Acorus tatarinowii, 5 parts by weight of Pheretima aspergillum.

[0092] Take Acorus tatarinowii and Angelica sinensis, add 6 times the amount of water, extract volatile oil and aromatic water by steam distillation method, add β - cyclodextrin and grind for inclusion, stir, refrigerate, filter to obtain the inclusion compound and dry it at low temperature for later use; keep the medicinal residues and the medicinal liquid for later use;

[0093] Take Salvia miltiorrhiza and Ginseng, extract twice with 90% ethanol. For the first extraction, add 10 times the amount of ethanol and extract for 2 hours. For the second extraction, add 8 times the amount of ethanol and extract for 1.5 hours. Filter and combine the extracts, recover ethanol under reduced pressure, and then concentrate under reduced pressure to obtain a clear extract with a relative density of 1.12 - 1.18 at 60°C or concentrate under reduced pressure to obtain a thick extract with a relative density of 1.30 - 1.35 at 60°C for later use; keep the medicinal residues for later use;

[0094] Take Astragalus membranaceus, Polygonatum sibiricum, Crataegus pinnatifida, Polygonum multiflorum Thunb. var. thomsonii, Lycium barbarum, Polygala tenuifolia, Pheretima aspergillum, and mix them with the medicinal residues of the above four herbs. Extract twice with water. For the first extraction, add 10 times the amount of water and extract for 1.0 hour. For the second extraction, add 8 times the amount of water and extract for 1.0 hour. Combine the filtrate with the medicinal liquid during the extraction of volatile oil, and concentrate under reduced pressure to obtain a clear extract with a relative density of 1.12 - 1.18 at 60°C or concentrate under reduced pressure to obtain a thick extract with a relative density of 1.30 - 1.35 at 60°C for later use;

[0095] Combine the above clear paste or thick paste, add the above volatile oil inclusion compound, add sucrose and water, mix well to obtain syrup.

[0096] Example 6: Decoction

[0097] A traditional Chinese medicine composition for treating senile and vascular dementia comprises the following raw materials in parts by weight: 100 parts by weight of astragalus, 30 parts by weight of salvia miltiorrhiza, 10 parts by weight of ginseng, 20 parts by weight of polygonatum, 8 parts by weight of angelica, 10 parts by weight of hawthorn, 10 parts by weight of processed polygonum multiflorum, 20 parts by weight of wolfberry, 10 parts by weight of polygala, 15 parts by weight of calamus, 10 parts by weight of earthworm and 10 parts by weight of poria.

[0098] Take Acorus calamus, Angelica sinensis, Salvia miltiorrhiza, Ginseng, Astragalus, Polygonatum sibiricum, Crataegus pinnatifida, Polygonum multiflorum processed, Lycium barbarum, Polygala tenuifolia, Pheretima lumbricoides, and Poria cocos, add water, and use a multifunctional tank that can collect volatile oil to extract twice, add 10 times the amount of water for the first time, extract for 1.0 hour, add 8 times the amount of water for the second time, extract for 1.0 hour, filtrate, and concentrate under reduced pressure to obtain a clear paste with a relative density of 1.12-1.18 at 60°C, add the collected volatile oil, and add refined honey or sugar (or invert sugar) to make a semi-fluid preparation.

[0099] Proof of effect:

[0100] The pharmaceutical composition of the present invention has the effects of invigorating qi and activating blood circulation, improving intelligence and strengthening the brain, and has a good therapeutic effect on senile dementia or cerebrovascular dementia and other cerebrovascular diseases. In order to confirm the efficacy of the pharmaceutical composition, the inventors conducted animal experiments and clinical experiments respectively, and the drug "brain-strengthening granules" used in the experiment were prepared according to the formula in Example 1.

[0101] (1) Main efficacy studies

[0102] The main pharmacodynamic study of Jiannao Granules on the learning and memory ability of rats with vascular dementia, the activity of type B monoamine oxidase in brain tissue, and the level of lipid peroxides was conducted. The effects on cerebral blood flow and cerebrovascular resistance in rabbits, as well as the protective effect of brain tissue ischemia and hypoxia, showed that:

[0103] ① Brain-strengthening granules can improve the learning and memory abilities of rats with vascular dementia, and reduce the levels of type B monoamine oxidase, peroxidase, and lipid peroxides in the brain tissues of rats with dementia.

[0104] ② Brain-enhancing granules can increase cerebral blood flow and reduce cerebral vascular resistance in rabbits.

[0105] ③ Brain-strengthening granules can prolong the survival time of mice with cerebral ischemia and hypoxia, and have a significant inhibitory effect on the increase in cerebral vascular permeability and brain index caused by cerebral hypoxia in rats.

[0106] The above conclusion provides a certain pharmacological basis for the adjuvant treatment of Jiannao Granules in cerebrovascular dementia and other cerebrovascular diseases.

[0107] (2) Toxicological studies

[0108] ① Acute toxicity: When mice were orally administered Jiannao Granules, the maximum daily dosage was 240 g crude drug / kg, which was 134.8 times the clinical dosage. No obvious toxic reactions were observed.

[0109] ② Long-term toxicity: The test results showed that when rats were intragastrically administered Jiannao Granules at doses of 7.92, 23.76, and 79.2 g crude drug / kg, which were 4.4, 13.3, and 44.5 times the clinical dosage respectively, for 6 consecutive months, there were no obvious effects on the appearance signs, behaviors, activities, food intake, urine and feces of the test animals. The body weights of the rats all increased to varying degrees. The results of routine blood tests, blood biochemistry, main organ coefficients, and pathological histological examinations of the rats showed that Jiannao Granules were safe for use at a dosage below 79.2 g crude drug / kg.

[0110] (3) Clinical efficacy studies

[0111] 1) Clinical efficacy observation of the empirical formula

[0112] The prescription of Jiannao Granules was developed on the basis of Dingzhi Pills (ginseng, polygala tenuifolia, poria cocos, acorus tatarinowii) for treating amnesia in "Emergency Prescriptions Worth a Thousand Gold" and combined with the clinical medication experience in treating cerebrovascular dementia. This formula has the effects of supplementing qi and promoting blood circulation, and enhancing intelligence and nourishing the brain. It is mainly used for treating cerebrovascular dementia of qi deficiency and blood stasis type. This formula was used to systematically treat 61 cases of vascular dementia in the Affiliated Hospital of Hunan College of Traditional Chinese Medicine. Among them, there were 31 cases in the treatment group and 30 cases in the control group. The control group took Piracetam, 0.8 g each time, three times a day. Both groups were treated for 8 weeks as the observation course. During the treatment, patients with hypertension and diabetes could take antihypertensive drugs and hypoglycemic drugs in addition, and other drugs were prohibited. The results are as follows:

[0113] ① Efficacy of Jiannao Granules on vascular dementia

[0114] Analysis of the efficacy of vascular dementia showed that in the treatment group, 1 case (3.23%) was basically controlled, 8 cases (26.67%) showed marked efficacy, 12 cases (40.0%) were effective, and 9 cases (30.0%) were ineffective, with a total effective rate of 70.0%. In the control group, 4 cases (13.33%) showed marked efficacy, 12 cases (40.0%) were effective, and 14 cases (46.67%) were ineffective, with a total effective rate of 53.35%. There was a significant difference between the two groups, indicating that the therapeutic effect of Jiannao Granules on vascular dementia was superior to that of the control group (P < 0.05).

[0115] ② Influence of Jiannao Granules on TCM dementia symptoms

[0116] Clinically, the main symptoms include forgetfulness, slow reaction, slurred speech, dizziness, irritability, soreness and weakness of the waist and knees, dull tongue color, etc. In the treatment group, 13 cases (47.93%) showed marked improvement, 16 cases (57.61%) had effective results, and 2 cases (6.45%) were ineffective, with a total effective rate of 93.55%. In the control group, 9 cases (30.0%) showed marked improvement, 8 cases (26.67%) had effective results, and 13 cases (43.33%) were ineffective, with a total effective rate of 56.67%. The curative effect of the treatment group was superior to that of the control group after statistical test (P < 0.05).

[0117] ③ Influence of Jiannao Granules on living ability

[0118] Clinically, taking self-care in daily life and the degree of resuming general social activities as observation indicators, there were 31 cases in the treatment group. 6 cases (19.35%) showed marked improvement, 7 cases (22.58%) had effective results, and 18 cases (58.06%) were ineffective, with a total effective rate of 41.94%. In the control group of 30 cases, 5 cases (16.67%) showed marked improvement, 6 cases (20.0%) had effective results, and 19 cases (63.33%) were ineffective, with a total effective rate of 36.67%. The two drugs had a certain improvement effect on living ability. Although the treatment group was slightly higher than the control group, there was no significant difference between the groups.

[0119] ④ Influence of Jiannao Granules on the integral values of different scales in patients

[0120] After medication, the scores of HDS in both groups and the MMSE dementia scale in the treatment group were significantly improved (P < 0.05). The MMSE of the treatment group was significantly better than that of the control group (P < 0.05), indicating that the two drugs had a certain therapeutic effect on dementia.

[0121] ⑤ Influence of Jiannao Granules on cerebral blood flow

[0122] In the treatment group, for the left anterior communicating artery (ACA) (VM, X±S, the same below), it was 29.87±1.56 before treatment and 31.62±1.66 after treatment; in the control group, for the left ACA, it was 31.96±2.64 before treatment and 34.50±1.67 after treatment. Compared with before treatment in their own groups, both groups showed significant differences (P < 0.05).

[0123] ⑥ Both Jiannao Granules and the control drug can increase the average blood flow velocity of ACA (P < 0.05), and there is also a tendency to increase the blood flow velocities of MCA and VA. After statistical test, there is no significant difference. This may be due to the relatively small number of blood vessels detected.

[0124] ⑦ Jiannao Granules can reduce the whole blood viscosity. There is a significant difference compared with before treatment in its own group (P < 0.05), and it also has a reducing effect on plasma viscosity and plasma specific viscosity (P < 0.05).

[0125] The above experimental results preliminarily show that Jiannao Granule has definite clinical efficacy for vascular dementia of qi deficiency and blood stasis type.

[0126] 2) Phase II clinical study:

[0127] Taking Duxil (almitrine) as the positive control drug, a stratified block random, double-blind, positive drug parallel control, multi-center Phase II clinical trial of this product in the treatment of vascular dementia of qi deficiency and blood stasis type was completed in Xiyuan Hospital of China Academy of Chinese Medical Sciences, West China Hospital of Sichuan University, the First Affiliated Hospital of Hunan College of Traditional Chinese Medicine, the First Affiliated Hospital of Henan College of Traditional Chinese Medicine, and the Affiliated Hospital of Liaoning College of Traditional Chinese Medicine. A total of 232 cases were enrolled and 222 cases were completed. The results are summarized as follows:

[0128] ① Mini-Mental State Examination (MMSE): There was no statistical significance in the difference in the total MMSE score before and after treatment and the difference rate of the total MMSE score before and after treatment in both the PP and ITT analyses between the two groups (P>0.05). Comprehensive analysis: The total effective rate of Jiannao Granule was 75.4%, and that of Duxil group was 73.6% (the results of ITT and PP analyses were basically the same), and there was no statistical significance in the comparison between the two groups (P>0.05). After deducting the central effect error, the obtained conclusion was the same as above (P>0.05).

[0129] ② Traditional Chinese medicine syndromes: The difference in the total score of traditional Chinese medicine syndromes before and after treatment and the difference rate of the total score of traditional Chinese medicine syndromes before and after treatment. In the PP and ITT analyses, the effects of the two groups were similar (P>0.05). Comprehensive analysis: The total effective rate of the Jiannao Granule group was 71.9%, and that of the Duxil group was 64.5% (the results of ITT and PP analyses were basically the same), and there was no statistical significance in the comparison between the two groups (P>0.05). After deducting the central effect error, the obtained conclusion was the same as above (P>0.05).

[0130] ③ Blood lipids and hemorheology: There was no statistical significance in the measured values, difference rates, and difference values of triglyceride (TG), total cholesterol (CHO), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) between the two groups (P>0.05).

[0131] There was no statistical significance in the measured values, difference rates, and difference values of medium shear whole blood viscosity, plasma viscosity, hematocrit, red blood cell deformation index, red blood cell aggregation index, high shear reduced viscosity, and low shear reduced viscosity between the two groups (P>0.05).

[0132] Age and gender had no significant effect on the comprehensive efficacy of intelligence (MMSE score) and the comprehensive efficacy of TCM syndromes in the two groups (P>0.05); the condition had no significant effect on the efficacy of TCM syndromes in the two groups (P>0.05); the condition had better efficacy on the comprehensive efficacy of intelligence (MMSE score) in mild patients of the Du Kexi group than in moderate patients (P<0.05), but the professional difference was small and had no practical significance.

[0133] ④ Safety analysis: After 3 months of medication, some laboratory and electrocardiogram examination indicators were abnormal. Adverse reactions occurred in 3 cases (2.6%) in group A and 4 cases (3.5%) in group B.

[0134] ⑤The results of Phase II clinical study suggest that this product is clinically effective in treating vascular dementia (Qi deficiency and blood stasis syndrome), and there is no statistical difference in the efficacy of the disease on vascular dementia compared with the control group. The experimental group has a better improvement in the efficacy of TCM symptoms (Qi deficiency and blood stasis syndrome) than the control group, and there is a statistical difference (P < 0.05) compared with the control group. The experimental group has a trend of improvement in some indicators of blood lipids and blood rheology. The experimental group may have adverse reactions such as dry mouth, anorexia, blurred vision, stomach discomfort, bloating, rash on the upper part of both lower limbs, increased uric acid, dry mouth, stomach discomfort and vomiting. The safety indicators did not show abnormalities related to the experimental drugs as determined by the researchers.

[0135] 3) Phase III clinical study:

[0136] According to the results of Phase II clinical study, in order to further verify and evaluate the safety and effectiveness of Jiannao Granule in treating vascular dementia (Qi deficiency and blood stasis syndrome), a stratified block randomized, double-blind, positive drug parallel controlled, multicenter Phase III clinical trial of this product in treating Qi deficiency and blood stasis type vascular dementia was completed at Xiyuan Hospital of China Academy of Chinese Medical Sciences, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, the First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Henan Provincial Institute of Traditional Chinese Medicine, the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine and the Third Affiliated Hospital of Hunan University of Traditional Chinese Medicine. A total of 468 cases were enrolled, of which 324 cases were completed in the experimental group. The results are summarized as follows:

[0137] ①Intelligent efficacy analysis

[0138] (a) Comprehensive analysis of intelligent efficacy

[0139] Per-Protocol, PP analysis (analysis in accordance with the research protocol): the control group had a significant efficacy of 17.76%, and a total improvement rate of 44.86% (n=107); the experimental group had a significant efficacy of 23.46%, and a total improvement rate of 60.80% (n=324). After deducting the center effect, the significant efficacy and total improvement rate of the experimental group were higher than those of the control group (P<0.05).

[0140] Intelligent Efficacy ITT Analysis (Intention-TO-Treat, ITT, Principle of Intention-to-Treat): The marked efficacy rate of the control group was 17.24%, and the total improvement rate was 44.83% (n = 116); the marked efficacy rate of the experimental group was 23.08%, and the total improvement rate was 60.06% (n = 338). After deducting the between-center effect, both the marked efficacy rate and the total improvement rate of the experimental group were higher than those of the control group (P < 0.05).

[0141] (b) MMSE Score Efficacy Analysis

[0142] PP Analysis of MMSE Score Change Value: After 3 months of treatment, the control group increased by 2.15 ± 1.49 (n = 107); the experimental group increased by 2.71 ± 1.85 (n = 324), and the increase value of the experimental group was greater than that of the control group (P < 0.05).

[0143] ITT Analysis of MMSE Score Change Value: After 3 months of treatment, the control group increased by 2.19 ± 1.57 (n = 116); the experimental group increased by 2.69 ± 1.90 (n = 338), and the increase value of the experimental group was greater than that of the control group (P < 0.05).

[0144] ② TCM Syndrome Efficacy Analysis

[0145] (a) Comprehensive Analysis of TCM Syndrome Efficacy

[0146] PP Analysis of TCM Syndrome Efficacy: The marked efficacy rate of the control group was 5.61%, and the total improvement rate was 41.12% (n = 107); the marked efficacy rate of the experimental group was 13.58%, and the total improvement rate was 58.33% (n = 324). After deducting the between-center effect, both the marked efficacy rate and the total improvement rate of the experimental group were higher than those of the control group (P < 0.05).

[0147] ITT Analysis of TCM Syndrome Efficacy: The marked efficacy rate of the control group was 5.17%, and the total improvement rate was 41.38% (n = 116); the marked efficacy rate of the experimental group was 13.91%, and the total improvement rate was 57.99% (n = 338). After deducting the between-center effect, both the marked efficacy rate and the total improvement rate of the experimental group were higher than those of the control group (P < 0.05).

[0148] (b) Analysis of the Efficacy of the Total TCM Syndrome Score

[0149] PP Analysis of the Change Value of the Total TCM Syndrome Score: After 3 months of treatment, the control group decreased by 4.28 ± 2.83 (n = 107); the experimental group decreased by 5.05 ± 3.03 (n = 324), and the decrease value of the experimental group was greater than that of the control group (P < 0.05).

[0150] ITT analysis of the change value of the total TCM syndrome score: After 3 months of treatment, the control group decreased by 4.29 ± 2.78 (n = 116); the experimental group decreased by 5.06 ± 3.10 (n = 338), and the decrease value of the experimental group was greater than that of the control group (P < 0.05).

[0151] ③ Efficacy analysis of the Blessed-Roth score

[0152] (a) Measured value of the Blessed-Roth score

[0153] PP analysis of the measured value of the Blessed-Roth score: From 1 month to 3 months of treatment, there was no significant difference in the measured value of the Blessed-Roth score between groups A and B (P > 0.05).

[0154] ITT analysis of the measured value of the Blessed-Roth score: From 1 month to 3 months of treatment, there was no significant difference in the measured value of the Blessed-Roth score between groups A and B (P > 0.05).

[0155] (b) Change value of the Blessed-Roth score

[0156] PP analysis of the change value of the Blessed-Roth score: After 3 months of treatment, the control group decreased by 2.79 ± 2.49 (n = 107); the experimental group decreased by 2.92 ± 2.74 (n = 324), and there was no significant difference between the two groups (P > 0.05).

[0157] ITT analysis of the change value of the Blessed-Roth score: After 3 months of treatment, the control group decreased by 2.80 ± 2.53 (n = 116); the experimental group decreased by 2.89 ± 2.76 (n = 338), and there was no significant difference between the two groups (P > 0.05).

[0158] (c) Change rate of the Blessed-Roth score

[0159] PP analysis of the change rate of the Blessed-Roth score: After 3 months of treatment, the control group decreased by 0.15 ± 0.13 (n = 107); the experimental group decreased by 0.15 ± 0.12 (n = 324), and there was no significant difference between the two groups (P > 0.05).

[0160] ITT analysis of the change rate of the Blessed-Roth score: After 3 months of treatment, the control group decreased by 0.15 ± 0.13 (n = 116); the experimental group decreased by 0.15 ± 0.12 (n = 338), and there was no significant difference between the two groups (P > 0.05).

[0161] (d) Efficacy of each index of the Blessed-Roth scale

[0162] There was no statistically significant difference in the indicators of Blessed-Roth scale between the AB group after 1, 2, and 3 months of medication (P>0.05).

[0163] ④Analysis of the efficacy of single indicators of TCM symptoms

[0164] After 3 months of medication, there was no statistically significant change in the level of various indicators of TCM symptoms in groups AB (except intellectual impairment) (P>0.05), and there was no statistically significant difference in tongue and pulse between groups AB after 3 months of medication (P>0.05).

[0165] ⑤Analysis of the efficacy of blood lipids and blood rheology

[0166] After 3 months of medication, there was no statistically significant difference in blood lipids and blood rheology indicators (actual data set) between groups AB (P>0.05), and the change values ​​between groups AB were not statistically significant (P>0.05).

[0167] ⑥Safety analysis

[0168] The safety data set (SS) included 461 cases, 4 cases of adverse events occurred in the control group, with an incidence of 3.42%; 19 cases of adverse events occurred in the experimental group, with an incidence of 5.52%, and there was no significant difference between the two groups (P>0.05). Among them, 1 case of adverse reaction occurred in the control group, with an incidence of 0.85%; 16 cases of adverse reactions occurred in the experimental group, with an incidence of 4.65%, and there was no significant difference between the two groups (P>0.05). Among them, 12 cases of dry mouth, 6 cases of constipation, and 2 cases of epistaxis occurred in the experimental group, which may be related to the drug. A few subjects had abnormal safety indicators after taking the drug, and the researchers judged that it was not related to the trial drug.

[0169] ⑦The results of the Phase III clinical study showed that Jiannao Granules were clinically effective in treating vascular dementia of qi deficiency and blood stasis type, and the efficacy of Jiannao Granules on vascular dementia was statistically different from that of the control group (P < 0.05). The efficacy of Jiannao Granules on TCM symptoms (qi deficiency and blood stasis syndrome) was better than that of the control group, and there was a statistical difference compared with the control group (P < 0.05). There was a trend of improvement in some indicators of blood lipids and blood rheology, but there was no statistical difference compared with the control group. There was a statistical difference in the improvement of Blessed-Roth score before and after medication (P < 0.05), but there was no statistical difference compared with the control group. The trial group may have adverse reactions such as dry mouth, anorexia, blurred vision, stomach discomfort, bloating, rash on the upper parts of both lower limbs, increased uric acid, dry mouth, epigastric discomfort, vomiting, constipation, and nosebleed. The safety indicators did not show abnormalities that the researchers judged to be related to the trial drugs. Therefore, the seven units involved in the clinical research of this product believe that: Brain Jianming Granules are clinically effective in the treatment of vascular dementia (Qi deficiency and blood stasis syndrome), with certain adverse reactions. A small number of subjects showed abnormal liver function indicators after taking the medicine, which the researchers judged to be unrelated to the study drugs.

[0170] (5) Effect conclusion

[0171] With the acceleration of the aging process of the population in China and the increasing incidence of cerebrovascular diseases, vascular dementia has become one of the main disabling diseases in China, being the first cause of senile dementia, seriously endangering the physical and mental health and quality of life of patients.

[0172] At present, there are only a few Western medicines with relatively definite curative effects on the market, such as donepezil hydrochloride, piracetam, dihydroergotoxine mesylate, etc. Due to the complex etiology and pathogenesis of vascular dementia and its long course, Western medicines are not suitable for long-term use due to their own side effects and price factors, and so far no Chinese patent medicine that can be successfully used for the treatment of this disease has been seen.

[0173] Jiannao Granule is derived from a prescription that has been clinically applied for many years and has the effects of replenishing qi and activating blood circulation, and improving intelligence and brain function. Preclinical main pharmacodynamic experiments suggest that this product can reduce the blood viscosity of model rats with qi deficiency and blood stasis type, improve blood rheology; reduce the length and weight of thrombus in rabbits and inhibit thrombus formation; can significantly improve the memory impairment of mice caused by scopolamine and improve spatial discrimination memory ability; have obvious improvement effects on the spatial discrimination memory consolidation disorder and memory impairment caused by sodium nitrite and ethanol; can significantly reduce the dopamine content in the brains of normal mice and the activity of acetylcholinesterase in the brains of mice with memory acquisition disorders. It can increase the cerebral blood flow of normal anesthetized dogs. And it can increase the cerebral blood flow of rabbits, reduce cerebrovascular resistance, prolong the survival time of mice with cerebral ischemia and hypoxia, and have obvious inhibitory effects on the increased cerebrovascular permeability and the increased brain index caused by cerebral ischemia and hypoxia in rats, while having extremely low toxicity.

[0174] In the stratified block random, double-blind, positive drug parallel control, multi-center Phase II and Phase III clinical trials of Jiannao Granule in the treatment of vascular dementia with qi deficiency and blood stasis type, the curative effect and safety of this product on vascular dementia with qi deficiency and blood stasis type were objectively evaluated. The results showed that this product was clinically judged to be effective in the treatment of vascular dementia with qi deficiency and blood stasis type, but there were certain adverse reactions such as dry mouth and constipation, and abnormal liver function indexes appeared in a few subjects after taking the medicine. The researchers judged that it had nothing to do with the research drug.

[0175] The content clarified in the above embodiments should be understood that these embodiments are only used to illustrate the present invention more clearly, rather than to limit the scope of the present invention. After reading the present invention, various equivalent forms of modification of these embodiments by those skilled in the art all fall within the scope defined by the appended claims of the present invention.

Claims

1. A Chinese medicine composition for treating vascular dementia of qi deficiency and blood stasis type, characterized in that: The invention is prepared from the following raw materials in parts by weight: 10-30 parts by weight of astragalus, 10-25 parts by weight of salvia miltiorrhiza, 3-10 parts by weight of ginseng, 6-15 parts by weight of polygonatum, 3-10 parts by weight of angelica, 5-12 parts by weight of hawthorn, 6-15 parts by weight of processed polygonum multiflorum, 6-15 parts by weight of wolfberry, 3-10 parts by weight of polygala, 6-15 parts by weight of calamus, and 3-10 parts by weight of earthworm; The preparation method of the Chinese medicine composition for treating Qi deficiency and blood stasis type vascular dementia comprises the following steps: Water is added to Acorus calamus and Angelica sinensis, volatile oil and aromatic water are extracted by steam method, inclusion agent β-cyclodextrin is added to include the volatile oil, stirring, refrigerating, filtering to obtain inclusion compound, drug residue I and drug solution I, and drying the inclusion compound; Take Danshen and ginseng, extract with solvent, combine the filtrate, and concentrate under reduced pressure to recover the solvent to obtain medicinal residue II and ointment II; Take astragalus, polygonatum, hawthorn, processed polygonum multiflorum, wolfberry, polygala, and earthworm, mix with the residues I and II, add water to extract, combine the obtained filtrate with the medicinal solution I, concentrate under reduced pressure, and obtain ointment III for standby use; Combine ointment II and ointment III, dry them, and then add the prepared inclusion compound to obtain a traditional Chinese medicine composition; The solvent for extracting Danshen and ginseng is ethanol with a volume percentage concentration of 50-95%, the extraction times are 1-3 times, 4-12 times the volume of ethanol is added each time, and the extraction time is 1-3 hours.

2. The Chinese medicine composition for treating vascular dementia of qi deficiency and blood stasis type according to claim 1, characterized in that: Add the following raw materials in parts by weight: 0.5-40 parts by weight of Poria cocos.

3. The Chinese medicine composition for treating vascular dementia of qi deficiency and blood stasis type according to claim 1, characterized in that: Add 5 to 10 times the volume of water to Acorus calamus and Angelica sinensis.

4. The Chinese medicine composition for treating vascular dementia of qi deficiency and blood stasis type according to claim 1, characterized in that: Ointment II is a clear ointment with a relative density of 1.10-1.20 at 55-65°C or a thick ointment with a relative density of 1.20-1.40; Ointment III is a clear ointment with a relative density of 1.10-1.20 or a thick ointment with a relative density of 1.20-1.40 at 55-65°C.

5. Use of a Chinese medicine composition for treating vascular dementia of qi deficiency and blood stasis type according to any one of claims 1 to 4 in preparing a medicament for treating vascular dementia of qi deficiency and blood stasis type.

6. The use according to claim 5, characterized in that: The preparation of the Chinese medicine composition for treating vascular dementia of qi deficiency and blood stasis type includes granules, tablets, capsules, extracts, syrups, oral liquids, pills and powders.