A traditional Chinese medicine composition for treating vascular dementia, a preparation method and application thereof

Abstract

This invention discloses a traditional Chinese medicine composition for treating vascular dementia, its preparation method, and its application, belonging to the field of traditional Chinese medicine technology. It includes the following raw medicinal materials: Rehmannia glutinosa (processed), Dioscorea opposita, Cornus officinalis (processed with wine), Alisma plantago-aquatica, Poria cocos, Paeonia suffruticosa, Cinnamomum cassia, Aconitum carmichaelii (processed), Acorus tatarinowii, Polygala tenuifolia (processed), Curcuma longa (processed with vinegar), Tortoise shell glue, Cervi cornu glue, Achyranthes bidentata, Cuscuta chinensis (processed with salt), Gastrodia elata, Taxillus chinensis, and Eucommia ulmoides (processed with salt). This invention also discloses the preparation method and application of the above-mentioned traditional Chinese medicine composition. The beneficial effects of this invention are: Based on the Shenqi Wan formula and combined with traditional Chinese medicine theory, this application yields a novel traditional Chinese medicine composition for treating vascular dementia. This composition can significantly improve symptoms such as cognitive decline and slow thinking in patients with vascular dementia, effectively delaying the rapid progression of the disease and providing a new treatment option for patients with vascular dementia.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular, it relates to a traditional Chinese medicine composition for treating vascular dementia and a preparation method and application thereof. BACKGROUND

[0002] Vascular dementia (VaD) is a complex clinical syndrome characterized by cognitive impairment caused by various cerebrovascular diseases. The most common cause of this condition is the obstruction of cerebral blood vessels, such as cerebral stenosis and cerebral infarction. These pathological changes lead to insufficient blood supply to the brain, which in turn affects the normal function of brain cells, especially those responsible for memory, learning, and thinking. Vascular dementia is particularly common in the elderly and is considered the second major cause of age-related dementia, with a higher incidence than the well-known Alzheimer's disease.

[0003] Despite the progress made by the medical community in the study of vascular dementia, there is still a lack of effective drugs for this condition. Therefore, early detection, early diagnosis, and early treatment have become important strategies for dealing with vascular dementia, with prevention being particularly critical, including primary prevention and secondary prevention, aiming to reduce the risk of vascular dementia by controlling risk factors such as hypertension and diabetes, and timely treatment of cerebrovascular lesions.

[0004] In terms of drug treatment, cholinesterase inhibitors and memantine are currently the two drugs approved by the US Food and Drug Administration (FDA) for the treatment of vascular dementia. However, the specific mechanisms of action and efficacy of these two drugs in treating vascular dementia still need more research to confirm. This means that, although they are used to some extent in clinical practice, their therapeutic effect and safety still need to be further evaluated.

[0005] Meanwhile, traditional Chinese medicine has shown unique advantages in the clinical treatment of vascular dementia in China. Traditional Chinese medicine theory believes that the occurrence of dementia is closely related to kidney deficiency and insufficient essence. With the growth of age, the kidney of the human body gradually declines, leading to insufficient essence to nourish the brain, and then appearing symptoms such as memory loss, slow thinking, etc. Ancient medical scientists such as Sun Simiao have discussed this, and believe that the gradual loss of kidney in the elderly and the emptying of brain marrow are one of the main causes of dementia. Based on this theory, traditional Chinese medicine treats dementia mainly by tonifying the kidney. Shengqi pill is a representative prescription among them. The pill is composed of dried rehmannia, dogwood, Chinese yam and other tonifying drugs, mainly tonifying kidney essence and kidney qi. At the same time, the combination of zexie, poria, peony and other dampness and fire reducing products in the prescription prevents the tonifying drugs from being too greasy and blocking the qi movement. In addition, a small amount of cassia twig and aconite are added to warm and tonify kidney yang, slightly generate fire, and promote the generation of kidney qi. This combination of tonifying and purging, tonifying without greasiness, enables shengqi pill to balance and harmonize the body while tonifying the kidney.

[0006] In view of this, the present inventors carried out in-depth research on this demand, and thus the present case was produced. SUMMARY

[0007] The prior art shows that shengqi pill can improve cognitive impairment behavior, and has good clinical safety and effectiveness in treating vascular dementia. However, long-term clinical observation found that kidney deficiency type of vascular dementia in elderly patients is more severe, and the effect of shengqi pill in tonifying the kidney is slow. Secondly, many elderly people have unbalanced qi and blood, phlegm and blood stasis blocking the collaterals, and the clear orifices are covered, resulting in phlegm and blood stasis covering the orifices and slow reaction. In addition, some patients have kidney deficiency, kidney essence loss, and appear symptoms such as soreness of the waist and knees, incontinence or nocturia.

[0008] In view of the above technical problems, the specific technical scheme of the present application is as follows:

[0009] A traditional Chinese medicine composition for treating vascular dementia, comprising the following raw medicinal materials: dried rehmannia, Chinese yam, wine cornus, zexie, poria, peony, cassia twig, light aconite tablet, alocasia macrorrhiza, prepared radix polygalae, vinegar turmeric, turtle shell glue, deer horn glue, milkweed, salt cuscuta, gastrodia elata, and salt eucommia.

[0010] Preferably, by mass parts, it comprises the following raw medicinal materials: dried rehmannia 10-20 parts, Chinese yam 10-20 parts, wine cornus 8-16 parts, zexie 8-16 parts, poria 8-16 parts, peony 8-16 parts, cassia twig 8-16 parts, light aconite tablet 5-13 parts, alocasia macrorrhiza 8-16 parts, prepared radix polygalae 8-16 parts, vinegar turmeric 8-16 parts, turtle shell glue 1-6 parts, deer horn glue 1-6 parts, milkweed 10-20 parts, salt cuscuta 10-20 parts, gastrodia elata 5-15 parts, and salt eucommia 10-20 parts.

[0011] Preferably, the raw medicinal materials include the following: Radix Rehmanniae Preparata 12-18 parts by mass, Dioscorea 12-18 parts by mass, Jiumu 10-14 parts by mass, Alisma orientalis 10-14 parts by mass, Poria cocos 10-14 parts by mass, Cortex Moutan 10-14 parts by mass, Ramulus Cinnamomi 10-14 parts by mass, Difupian 7-11 parts by mass, Acorus gramineus 10-14 parts by mass, Radix Polygalae 10-14 parts by mass, Radix Curcumae 10-14 parts by mass, Tortoise Shell Glue 2-5 parts by mass, Antler Glue 2-5 parts by mass, Radix Anemarrhenae 12-18 parts by mass, Semen Litchi 12-18 parts by mass, Gastrodia 7-13 parts by mass, Taxillus 12-18 parts by mass, and Eucommia ulmoides 12-18 parts by mass.

[0012] Preferably, the raw medicinal materials include the following: Radix Rehmanniae Preparata 14-16 parts by mass, Dioscorea 14-16 parts by mass, Jiumu 11-13 parts by mass, Alisma orientalis 11-13 parts by mass, Poria cocos 11-13 parts by mass, Cortex Moutan 11-13 parts by mass, Ramulus Cinnamomi 11-13 parts by mass, Difupian 8-10 parts by mass, Acorus gramineus 11-13 parts by mass, Radix Polygalae 11-13 parts by mass, Radix Curcumae 11-13 parts by mass, Tortoise Shell Glue 3-4 parts by mass, Antler Glue 3-4 parts by mass, Radix Anemarrhenae 14-16 parts by mass, Semen Litchi 14-16 parts by mass, Gastrodia 9-11 parts by mass, Taxillus 14-16 parts by mass, and Eucommia ulmoides 14-16 parts by mass.

[0013] Preferably, the raw medicinal materials include the following: Radix Rehmanniae Preparata 14-16 parts by mass, Dioscorea 14-16 parts by mass, Jiumu 11-13 parts by mass, Alisma orientalis 11-13 parts by mass, Poria cocos 11-13 parts by mass, Cortex Moutan 11-13 parts by mass, Ramulus Cinnamomi 11-13 parts by mass, Difupian 8-10 parts by mass, Acorus gramineus 11-13 parts by mass, Radix Polygalae 11-13 parts by mass, Radix Curcumae 11-13 parts by mass, Tortoise Shell Glue 3-4 parts by mass, Antler Glue 3-4 parts by mass, Radix Anemarrhenae 14-16 parts by mass, Semen Litchi 14-16 parts by mass, Gastrodia 9-11 parts by mass, Taxillus 14-16 parts by mass, and Eucommia ulmoides 14-16 parts by mass.

[0014] Preferably, the Tortoise Shell Glue and the Antler Glue need to be processed by traditional Chinese medicine melting when being used as medicine.

[0015] The application also provides the use of the traditional Chinese medicine composition for treating vascular dementia in the preparation of a medicine for treating vascular dementia.

[0016] The application also provides a medicine for treating vascular dementia, which comprises the traditional Chinese medicine composition for treating vascular dementia and a pharmaceutically acceptable excipient.

[0017] Preferably, the dosage form of the medicine is a traditional Chinese medicine decoction, a decoction, a granule, a pill, a capsule, a tablet, a tea, a suspension, a powder or an oral liquid.

[0018] The application also provides a preparation method of the medicine for treating vascular dementia.

[0019] Step one: weigh and take the raw medicinal materials except the Tortoise Shell Glue and the Antler Glue, clean, dry, cut, crush, sieve and mix uniformly;

[0020] Step two, add water to cover the raw materials taken in step one 1-3 cm and soak for 30-50 minutes, then use strong fire to boil, and then continue to boil with small fire for 50-70 minutes, filter with Chinese medicine sieve, to obtain the first filtrate; add water to cover the medicine residue, boil with strong fire, and then continue to boil with small fire for 50-70 minutes, filter the medicine residue with Chinese medicine sieve, to obtain the second filtrate; combine the first filtrate and the second filtrate;

[0021] Step three, add turtle shell glue and deer horn glue into the combined filtrate in step two, mix evenly, and place in a vacuum drying machine, dry at a temperature of 40-60℃ and a pressure of 5-6KPa until the weight no longer decreases, to obtain granules.

[0022] The application also provides a preparation method of the medicine for treating vascular dementia, and the medicine is a pill, and the preparation method is as follows:

[0023] Step one, weigh and take the raw materials except turtle shell glue and deer horn glue according to the weight ratio, clean, dry, cut, crush, sieve, and mix evenly;

[0024] Step two, add water to cover the raw materials taken in step one 1-3 cm and soak for 30-50 minutes, then use strong fire to boil, and then continue to boil with small fire for 50-70 minutes, filter with Chinese medicine sieve, to obtain the first filtrate; add water to cover the medicine residue, boil with strong fire, and then continue to boil with small fire for 50-70 minutes, filter the medicine residue with Chinese medicine sieve, to obtain the second filtrate; combine the first filtrate and the second filtrate, and place in a vacuum drying machine, dry at a temperature of 40-60℃ and a pressure of 5-6KPa until the weight no longer decreases;

[0025] Step three, heat honey to 100-120℃, then mix the dried medicine in step two with the honey according to a mass ratio of 1:1.2, mix evenly, add turtle shell glue and deer horn glue, and continue to heat with small fire for 15-25 minutes at 100-120℃, then naturally cool to room temperature, and then add to a pill making machine, to obtain a pill.

[0026] The application also provides a preparation method of the medicine for treating vascular dementia, and the medicine is a paste, and the preparation method is as follows:

[0027] Step one, weigh and take the raw materials except turtle shell glue and deer horn glue according to the weight ratio, clean, dry, cut, crush, sieve, and mix evenly;

[0028] Step 2: Add water to cover the raw materials obtained in Step 1 by 1-3 cm and soak for 30-50 minutes. Then bring to a boil over high heat, and then simmer over low heat for 50-70 minutes. Filter using a Chinese medicine sieve to obtain the first filtrate. Add water to the dregs to cover them, bring to a boil over high heat, and then simmer over low heat for 50-70 minutes. Filter out the dregs using a Chinese medicine sieve to obtain the second filtrate. Combine the first and second filtrates and place them in a vacuum dryer at a temperature of 40-60℃ and a pressure of 5-6 kPa until the weight no longer decreases.

[0029] Step 3: Heat the honey to 100-120℃, then mix it with the dried medicine from Step 2, honey, and water in a mass ratio of 1:1.2:2. Add tortoise shell glue and deer antler glue and mix well. Simmer over low heat at 100-120℃, stirring constantly. When the medicine reaches the "hanging flag" stage, pour the ointment into a dry container to obtain the ointment.

[0030] The beneficial effects of adopting the technical solution of this invention are as follows:

[0031] The traditional Chinese medicine composition provided by this invention uses Rehmannia glutinosa, Cinnamomum cassia, tortoise shell glue, and deer antler glue as the principal ingredients, which are specifically used to tonify the kidneys and brain. Rehmannia glutinosa is neutral in nature, sweet and warm, and tonifies and unblocks the kidneys, and can replenish the true yin of the five internal organs. Cinnamomum cassia is pungent, sweet and warm, and warms and unblocks yang qi, tonifies kidney yang, and assists qi transformation. Tortoise shell and deer antler glue are both products of flesh and blood. Deer antler is sweet, salty and slightly warm, and unblocks the Du meridian to warm and tonify yang. Tortoise shell is sweet, salty and cold, and unblocks the Ren meridian to replenish yin essence. The four principal ingredients work together to strongly tonify yin and yang to generate qi, blood and essence. Aconite root, Dioscorea opposita, Cornus officinalis, Taxillus chinensis, Eucommia ulmoides, and Cuscuta chinensis are the assistant ingredients. Among them, aconite root and Cuscuta chinensis can warm the kidneys, benefit essence and transform qi, and enhance the warming and unblocking power of deer antler. Dioscorea opposita and Cornus officinalis can help the principal ingredients tonify kidney essence, tonify the spleen and lungs, and prevent collapse. Taxillus chinensis and Eucommia ulmoides can help Rehmannia glutinosa tonify the liver and kidneys and strengthen the waist and knees. The formula is supplemented with Acorus tatarinowii, Curcuma longa, and Polygala tenuifolia to resolve phlegm, open the orifices, and improve mental clarity. Gastrodia elata is added to tonify kidney yang, open the orifices, and unblock blood vessels. Moutan bark is then added to clear heat and invigorate blood, Poria cocos to strengthen the spleen and resolve dampness, and Alisma plantago-aquatica to clear turbidity and purge heat, preventing the large group of tonifying herbs from stagnating and generating damp-heat over time. Achyranthes bidentata is used as an adjuvant to guide the other herbs to move smoothly and effectively towards the lower burner (liver and kidneys). The combined effects of this formula nourish kidney qi, blood, and essence, while simultaneously opening the orifices, awakening the mind, regulating qi, and unblocking the meridians, thus improving the clinical symptoms of patients with kidney deficiency-type vascular dementia from multiple perspectives and significantly enhancing their quality of life.

[0032] In addition, the traditional Chinese medicine composition provided by this invention uses natural Chinese medicine for treatment, which has a stronger and more specific effect of tonifying kidney qi and replenishing essence. It can also open the orifices and refresh the mind, regulate qi and unblock the meridians. It can improve common symptoms of vascular dementia patients such as memory loss, abnormal urination, fear of cold limbs, and discomfort in the waist and knees. Furthermore, it provides preparation methods for various drug dosage forms suitable for this formula, which can be flexibly selected by vascular dementia patients, thereby enhancing the convenience of drug administration, making it easier for patients to adhere to drug treatment, and enhancing the efficacy. Detailed Implementation

[0033] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, not all of them. Therefore, the detailed description of the embodiments provided by the present invention below is not intended to limit the scope of the claimed invention, but merely to represent selected embodiments of the invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without inventive effort are within the scope of protection of the present invention.

[0034] This embodiment fully analyzes the severe kidney essence deficiency in elderly patients with kidney deficiency-type vascular dementia, and the slow effect of Shenqi Wan (a traditional Chinese medicine formula) in tonifying the kidneys. Secondly, as people age, their qi and blood are often weak, phlegm and blood stasis obstruct the collaterals, and the sensory orifices are clouded, resulting in phlegm and blood stasis obstructing the orifices and slow reactions. In addition, some patients have kidney qi deficiency and kidney essence loss, resulting in related problems such as soreness and weakness of the lower back and knees, urinary incontinence, or increased nocturia. Therefore, a traditional Chinese medicine composition for treating vascular dementia, its preparation method, and its application are invented, including the following raw materials: Rehmannia glutinosa, Dioscorea opposita, Cornus officinalis, Alisma plantago-aquatica, Poria cocos, Paeonia suffruticosa, Cinnamomum cassia, Aconitum carmichaelii, Acorus tatarinowii, Polygala tenuifolia, Curcuma longa, Tortoise shell glue, Deer antler glue, Achyranthes bidentata, Cuscuta chinensis, Gastrodia elata, Taxillus chinensis, and Eucommia ulmoides.

[0035] The traditional Chinese medicine composition for treating vascular dementia provided in this application includes:

[0036] Rehmannia glutinosa (processed): Sweet in taste, slightly warm in nature, and enters the liver and kidney meridians. It has the effects of nourishing blood and yin, replenishing essence and marrow. It is mainly used to treat blood deficiency and chlorosis, palpitations, irregular menstruation, metrorrhagia, liver and kidney yin deficiency, soreness and weakness of the waist and knees, bone steaming fever, night sweats and seminal emission, internal heat and thirst, dizziness, tinnitus, and premature graying of hair.

[0037] Yam: Sweet in taste, neutral in nature, and enters the spleen, lung, and kidney meridians. It has the effects of tonifying the spleen and stomach, promoting body fluid production and benefiting the lungs, and tonifying the kidneys and astringing essence. It is mainly used to treat spleen deficiency with poor appetite, chronic diarrhea, lung deficiency with cough and asthma, kidney deficiency with seminal emission, leukorrhea, frequent urination, and thirst due to deficiency heat.

[0038] Cornus officinalis: It has a sour and astringent taste, is slightly warm in nature, and enters the liver and kidney meridians. It has the effects of tonifying the liver and kidneys, and astringing and consolidating. It is mainly used to treat soreness and weakness of the lower back and knees, dizziness and tinnitus, impotence and seminal emission, enuresis and frequent urination, metrorrhagia and leukorrhea, profuse sweating and collapse, and internal heat and thirst.

[0039] Alisma plantago-aquatica: Sweet and bland in taste, cold in nature, and enters the kidney and bladder meridians. It has the effects of promoting diuresis and eliminating dampness, clearing heat, resolving turbidity and lowering lipids. It is mainly used to treat dysuria, edema, diarrhea with scanty urine, phlegm retention and dizziness, painful urination due to heat, and hyperlipidemia.

[0040] Poria cocos: Sweet and bland in taste, neutral in nature, and enters the heart, lung, spleen, and kidney meridians. It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen, and calming the mind. It is mainly used to treat edema with scanty urine, phlegm retention with dizziness and palpitations, spleen deficiency with poor appetite, loose stools and diarrhea, restlessness, palpitations, and insomnia.

[0041] Cortex Moutan: bitter, pungent, slightly cold, returns to the heart, liver, and kidney channels. It has the effects of clearing heat and cooling blood, and promoting blood circulation to remove blood stasis. It is used to treat warm toxin with skin rashes, blood heat with bleeding, warm disease damaging yin, yin deficiency with fever, night fever and early cooling, no sweating with bone dryness, amenorrhea and painful periods, accumulation of masses, and sprains and injuries.

[0042] Cassia Bark: pungent, sweet, warm, returns to the heart, lung, and bladder channels. It has the effects of inducing sweating to relieve the exterior, warming and unblocking meridians, and assisting yang and transforming qi. It is used to treat wind-cold syndrome, cold pain in the abdomen, blood cold with amenorrhea, arthralgia, phlegm retention, edema, and palpitation.

[0043] Dried Aconite Root (a processed product of Aconite Root): pungent, sweet, extremely hot, returns to the heart, kidney, and spleen channels. It has the effects of restoring yang, rescuing from collapse, supplementing fire and assisting yang, dispelling cold and relieving pain. It is used to treat yang collapse, cold limbs and weak pulse, heart yang deficiency, chest pain, cold abdominal pain, kidney yang deficiency, impotence and cold uterus, cold edema, yang deficiency with external invasion, cold dampness with arthralgia, and cold dampness with arthralgia.

[0044] Rhizoma Acori Tatarinowii: pungent, bitter, warm, returns to the heart and stomach channels. It has the effects of opening the orifices, dispelling phlegm, refreshing the mind, and promoting digestion. It is used to treat phlegm blocking the orifices, mental confusion, epilepsy, amnesia, insomnia, tinnitus, deafness, abdominal fullness without hunger, lockjaw with diarrhea, and dampness in the middle-jiao.

[0045] Prepared Polygala: same as Polygala, but after processing, it may enhance its effects of soothing the mind, dispelling phlegm, and reduce certain side effects.

[0046] Vinegar Turmeric: pungent, bitter, cold, returns to the liver, heart, and lung channels. It has the effects of promoting blood circulation to stop pain, regulating qi to relieve stagnation, clearing the heart and cooling blood, and promoting bile discharge to reduce jaundice. It is used to treat chest and hypochondriac pain, chest pain, dysmenorrhea and amenorrhea, breast distending pain, delirium in febrile disease, epilepsy, blood heat with bleeding, and jaundice with red urine.

[0047] Tortoise Shell Glue: sweet, salty, neutral, returns to the liver, kidney, and heart channels. It has the effects of nourishing yin and blood, and stopping bleeding. It is used to treat yin deficiency with tidal fever, bone dryness with night sweating, dizziness and blurred vision, internal wind due to deficiency, flaccid muscles and joints, heart deficiency with forgetfulness, metrorrhagia, and leukorrhagia.

[0048] Deer Antler Glue: sweet, salty, warm, returns to the kidney and liver channels. It has the effects of warming and tonifying the liver and kidney, and nourishing essence and blood. It is used to treat impotence and spermatorrhea, cold and soreness of the waist and knees, deficiency debility, metrorrhagia, hematochezia, hematuria, and yin sores and ulcers.

[0049] Radix Achyranthis Bidentatae: bitter, sweet, and sour, neutral, returns to the liver and kidney channels. It has the effects of removing blood stasis, regulating menstruation, tonifying the liver and kidney, strengthening the tendons and bones, promoting urination to treat stranguria, and promoting blood downward flow. It is used to treat blood stasis and blockage with amenorrhea, dysmenorrhea, abdominal pain during menstruation, retained lochia, sprains and injuries, soreness and pain of the waist and knees, flaccidity of the lower limbs, stranguria, edema, dizziness, sores on the tongue, vomiting of blood, and bleeding.

[0050] Salted dodder seed: It has a pungent and sweet taste, is neutral in nature, and enters the liver, kidney, and spleen meridians. It has the effects of tonifying the kidneys and replenishing essence, nourishing the liver and improving eyesight, and strengthening the spleen and stopping diarrhea. It is mainly used to treat lower back and knee weakness, impotence, seminal emission, enuresis, frequent urination, blurred vision, tinnitus, and diarrhea due to spleen and kidney deficiency.

[0051] Gastrodia elata: sweet in taste, neutral in nature, and enters the liver meridian. It has the effects of calming wind and stopping spasms, suppressing liver yang, and dispelling wind and unblocking the meridians. It is mainly used to treat infantile convulsions, epilepsy, tetanus, headache and dizziness, hemiplegia, numbness of limbs, and rheumatic pain.

[0052] Mistletoe: Bitter and sweet in taste, neutral in nature, and enters the liver and kidney meridians. It has the effects of dispelling wind and dampness, tonifying the liver and kidneys, strengthening tendons and bones, and calming the fetus. It is mainly used to treat rheumatic pain, soreness and weakness of the lower back and knees, weakness of tendons and bones, metrorrhagia, threatened miscarriage, and threatened abortion.

[0053] Salt-processed Eucommia: Sweet and slightly pungent in taste, warm in nature, and enters the liver and kidney meridians. It tonifies the liver and kidneys, strengthens tendons and bones, and calms the fetus. It is mainly used to treat kidney deficiency-related lower back pain and various types of lower back pain, threatened miscarriage, and habitual abortion. Salt processing further enhances its kidney-tonifying effects.

[0054] As a preferred embodiment, the raw medicinal materials, by weight, include the following: 10-20 parts of Rehmannia glutinosa (processed), 10-20 parts of Dioscorea opposita, 8-16 parts of Cornus officinalis (processed with wine), 8-16 parts of Alisma plantago-aquatica, 8-16 parts of Poria cocos, 8-16 parts of Paeonia suffruticosa, 8-16 parts of Cinnamomum cassia, 5-13 parts of Aconitum carmichaelii (processed with wine), 8-16 parts of Acorus tatarinowii, 8-16 parts of Polygala tenuifolia (processed with wine), 8-16 parts of Curcuma longa (processed with vinegar), 1-6 parts of tortoise shell glue, 1-6 parts of deer antler glue, 10-20 parts of Achyranthes bidentata, 10-20 parts of Cuscuta chinensis (processed with salt), 5-15 parts of Gastrodia elata, 10-20 parts of Taxillus chinensis, and 10-20 parts of Eucommia ulmoides (processed with salt).

[0055] As a preferred embodiment, the raw medicinal materials, by weight, include the following: 12-18 parts of Rehmannia glutinosa (processed), 12-18 parts of Dioscorea opposita, 10-14 parts of Cornus officinalis (processed with wine), 10-14 parts of Alisma plantago-aquatica, 10-14 parts of Poria cocos, 10-14 parts of Paeonia suffruticosa, 10-14 parts of Cinnamomum cassia, 7-11 parts of Aconitum carmichaelii (processed with wine), 10-14 parts of Acorus tatarinowii, 10-14 parts of Polygala tenuifolia (processed with wine), 10-14 parts of Curcuma longa (processed with vinegar), 2-5 parts of tortoise shell glue, 2-5 parts of deer antler glue, 12-18 parts of Achyranthes bidentata, 12-18 parts of Cuscuta chinensis (processed with salt), 7-13 parts of Gastrodia elata, 12-18 parts of Taxillus chinensis, and 12-18 parts of Eucommia ulmoides (processed with salt).

[0056] As a preferred embodiment, the raw medicinal materials include the following: Radix Rehmanniae Preparata 14-16 parts, Rhizoma Dioscoreae 14-16 parts, Fructus Corni 11-13 parts, Rhizoma Alismatis 11-13 parts, Poria 11-13 parts, Cortex Moutan 11-13 parts, Ramulus Cinnamomi 11-13 parts, Excrementum Fel 8-10 parts, Rhizoma Acori 11-13 parts, Radix Polygalae Preparata 11-13 parts, Radix Curcumae 11-13 parts, Testa Carapacis Trunculi 3-4 parts, Cornu Cervi 3-4 parts, Radix Anemarrhenae 14-16 parts, Semen Litchi 14-16 parts, Radix Salicae 9-11 parts, Ramulus Loropetali 14-16 parts, and Radix Eucommiae 14-16 parts.

[0057] As a preferred embodiment, the raw medicinal materials include the following: Radix Rehmanniae Preparata 15 parts, Rhizoma Dioscoreae 15 parts, Fructus Corni 12 parts, Rhizoma Alismatis 12 parts, Poria 12 parts, Cortex Moutan 12 parts, Ramulus Cinnamomi 12 parts, Excrementum Fel 9 parts, Rhizoma Acori 12 parts, Radix Polygalae Preparata 12 parts, Radix Curcumae 12 parts, Testa Carapacis Trunculi 3 parts, Cornu Cervi 3 parts, Radix Anemarrhenae 15 parts, Semen Litchi 15 parts, Radix Salicae 10 parts, Ramulus Loropetali 15 parts, and Radix Eucommiae 15 parts.

[0058] As a preferred embodiment, the Testa Carapacis Trunculi and the Cornu Cervi need to be processed by melting when being used as medicine.

[0059] The application also provides the use of the above-mentioned Chinese medicine composition for treating vascular dementia in the preparation of a medicine for treating vascular dementia.

[0060] The application also provides a medicine for treating vascular dementia, which includes the above-mentioned Chinese medicine composition for treating vascular dementia and a pharmaceutically acceptable excipient.

[0061] As a preferred embodiment, the dosage form of the medicine is a Chinese medicine decoction, a decoction, a granule, a pill, a capsule, a tablet, a tea, a suspension, a powder or an oral liquid.

[0062] The application also provides a preparation method of the above-mentioned medicine for treating vascular dementia, and when the medicine is a granule, the preparation method is as follows:

[0063] Step one, the raw medicinal materials except the Testa Carapacis Trunculi and the Cornu Cervi are weighed, cleaned, dried, cut, crushed, sieved and mixed uniformly;

[0064] Step two, water is added to cover the raw medicinal materials by 1-3 cm and soaked for 30-50 minutes, then boiled with a strong fire and continue to boil with a weak fire for 50-70 minutes, filtered with a Chinese medicine sieve to obtain a first filtrate; water is added to cover the medicinal residues, boiled with a strong fire and continue to boil with a weak fire for 50-70 minutes, filtered to remove the medicinal residues with a Chinese medicine sieve to obtain a second filtrate; the first filtrate and the second filtrate are combined;

[0065] Step three, add tortoise shell glue and deer horn glue into the combined filtrate in step two and mix evenly, and then place in a vacuum drying machine and dry at a temperature of 40-60 DEG C and a pressure of 5-6 KPa until the weight no longer decreases to obtain granules.

[0066] The application also provides a preparation method of the medicine for treating vascular dementia, which is a pill, and the preparation method is as follows:

[0067] Step one, weigh and take the raw medicinal materials except tortoise shell glue and deer horn glue according to the weight ratio, clean and select, dry, cut, crush, sieve, and mix evenly;

[0068] Step two, add water to cover the raw medicinal materials in step one by 1-3 cm and soak for 30-50 minutes, then use strong fire to boil, and then use weak fire to continue boiling for 50-70 minutes, filter using a Chinese medicine sieve to obtain a first filtrate; add water to cover the medicinal residues by 1-3 cm, use strong fire to boil, and then use weak fire to continue boiling for 50-70 minutes, filter using a Chinese medicine sieve to remove the medicinal residues to obtain a second filtrate; combine the first filtrate and the second filtrate, and place in a vacuum drying machine and dry at a temperature of 40-60 DEG C and a pressure of 5-6 KPa until the weight no longer decreases;

[0069] Step three, heat honey to 100-120 DEG C, then mix the dried medicine in step two with the honey according to a mass ratio of 1:1.2, add tortoise shell glue and deer horn glue and mix evenly, and then use small fire to simmer for 15-25 minutes at 100-120 DEG C, then naturally reduce to room temperature, and then add to a pill making machine to obtain a pill.

[0070] The application also provides a preparation method of the medicine for treating vascular dementia, which is a paste, and the preparation method is as follows:

[0071] Step one, weigh and take the raw medicinal materials except tortoise shell glue and deer horn glue according to the weight ratio, clean and select, dry, cut, crush, sieve, and mix evenly;

[0072] Step two, add water to cover the raw medicinal materials in step one by 1-3 cm and soak for 30-50 minutes, then use strong fire to boil, and then use weak fire to continue boiling for 50-70 minutes, filter using a Chinese medicine sieve to obtain a first filtrate; add water to cover the medicinal residues by 1-3 cm, use strong fire to boil, and then use weak fire to continue boiling for 50-70 minutes, filter using a Chinese medicine sieve to remove the medicinal residues to obtain a second filtrate; combine the first filtrate and the second filtrate, and place in a vacuum drying machine and dry at a temperature of 40-60 DEG C and a pressure of 5-6 KPa until the weight no longer decreases;

[0073] Step three, heat the honey to 100-120℃, then mix the dry medicine, honey and water in step two according to the mass ratio of 1:1.2:2, add tortoise shell glue and deer horn glue, mix well, and simmer at low heat at 100-120℃, and continuously stir. When the medicine is hung, pour the paste into a dry container to obtain the paste.

[0074] The application will be further described in detail below with specific examples:

[0075] Example 1

[0076] A traditional Chinese medicine composition for treating vascular dementia, the following mass parts of traditional Chinese medicine formula raw materials are taken: 10 parts of Radix Rehmanniae Preparata, 10 parts of Rhizoma Dioscoreae, 8 parts of Fructus Corni, 8 parts of Rhizoma Alismatis, 8 parts of Poria, 8 parts of Cortex Moutan, 8 parts of Ramulus Cinnamomi, 5 parts of Fructus Aurantii Immaturus, 8 parts of Rhizoma Acori Tatarinowii, 8 parts of Radix Polygalae, 1 part of tortoise shell glue, 1 part of deer horn glue, 10 parts of Radix Anemarrhenae, 10 parts of Semen Litchi, 5 parts of Gastrodia, 10 parts of Taxillus, and 10 parts of Radix Paeoniae Alba. The medicine for treating vascular dementia in Example 1 is a granule, and the preparation method is as follows:

[0077] Step one, the raw medicine materials except tortoise shell glue and deer horn glue are weighed and taken according to the weight ratio, cleaned, dried, cut, ground, sieved, and mixed well;

[0078] Step two, water is added to cover the raw medicine materials taken in step one by 3 cm and soaked for 50 minutes, then boiled with strong fire, and continue to boil with weak fire for 60 minutes. The medicine is filtered with a traditional Chinese medicine filter to obtain a first filtrate. Water is added to cover the medicine residue, boiled with strong fire, and continue to boil with weak fire for 60 minutes. The medicine residue is filtered to obtain a second filtrate. The first filtrate and the second filtrate are combined.

[0079] Step three, tortoise shell glue and deer horn glue are added to the combined filtrate in step two and mixed well, and then placed in a vacuum drying machine to dry at a temperature of 50℃ and a pressure of 6KPa until the weight no longer decreases to obtain a granule.

[0080] Example 2

[0081] A traditional Chinese medicine composition for treating vascular dementia, the following mass parts of traditional Chinese medicine formula raw materials are taken: 12 parts of Radix Rehmanniae Preparata, 12 parts of Rhizoma Dioscoreae, 10 parts of Fructus Corni, 10 parts of Rhizoma Alismatis, 10 parts of Poria, 10 parts of Cortex Moutan, 10 parts of Ramulus Cinnamomi, 7 parts of Fructus Aurantii Immaturus, 10 parts of Rhizoma Acori Tatarinowii, 10 parts of Radix Polygalae, 2 parts of tortoise shell glue, 2 parts of deer horn glue, 12 parts of Radix Anemarrhenae, 12 parts of Semen Litchi, 7 parts of Gastrodia, 12 parts of Taxillus, and 12 parts of Radix Paeoniae Alba. The medicine for treating vascular dementia in Example 2 is a pill, and the preparation method is as follows:

[0082] Step one, according to the weight ratio of the raw materials except for the tortoise shell glue and deer horn glue, net selection, drying, cutting, crushing, sieving, mixing evenly;

[0083] Step two, add water to cover the raw materials taken in step one by 3 cm and soak for 40 minutes, then use strong fire to boil, and then continue to decoct for 60 minutes with small fire, filter using a Chinese medicine sieve to obtain a first filtrate; add water to cover the drug residue in the first filtrate by 2 cm, boil with strong fire, and then continue to decoct for 60 minutes with small fire, filter using a Chinese medicine sieve to remove the drug residue to obtain a second filtrate; combine the first filtrate and the second filtrate, and place them in a vacuum drying machine to dry at a temperature of 60℃ and a pressure of 6KPa until the weight no longer decreases;

[0084] Step three, heat the honey to 110℃, then mix the dried medicine of step two with the honey and water according to a mass ratio of 1:1.2:2, and then add the tortoise shell glue and the deer horn glue and mix them evenly, and then simmer for 20 minutes at 110℃ with small fire, and then naturally reduce to room temperature, and then add them into a pill making machine to obtain pills.

[0085] Example 3

[0086] A kind of traditional Chinese medicine composition for treating vascular dementia, according to the following mass fraction of traditional Chinese medicine formula raw materials: 14 parts of radix rehmanniae preparata, 14 parts of radix dioscoreae, 11 parts of jujube, 11 parts of alisma orientalis, 11 parts of poria cocos, 11 parts of cortex moutan, 11 parts of cassia twig, 8 parts of light fufang, 11 parts of radix polygalae, 11 parts of prepared rhizoma anemarrhenae, 11 parts of vinegar radix curcumae, 3 parts of tortoise shell glue, 3 parts of deer horn glue, 14 parts of radix astragali, 14 parts of salt pharbitidis, 9 parts of gastrodia elata, 14 parts of taxillus, 14 parts of salt eucommia. The medicine for treating vascular dementia in this example 3 is a paste, and its preparation method is:

[0087] Step one, according to the weight ratio of the raw materials except for the tortoise shell glue and deer horn glue, net selection, drying, cutting, crushing, sieving, mixing evenly;

[0088] Step two, add water to cover the raw materials taken in step one by 2 cm and soak for 40 minutes, then use strong fire to boil, and then continue to decoct for 50 minutes with small fire, filter using a Chinese medicine sieve to obtain a first filtrate; add water to cover the drug residue in the first filtrate by 2 cm, boil with strong fire, and then continue to decoct for 50 minutes with small fire, filter using a Chinese medicine sieve to remove the drug residue to obtain a second filtrate; combine the first filtrate and the second filtrate, and place them in a vacuum drying machine to dry at a temperature of 40℃ and a pressure of 5KPa until the weight no longer decreases;

[0089] Step three, heat the honey to 120℃, then mix the dried medicine of step two with the honey and water according to a mass ratio of 1:1.2:2, and then add the tortoise shell glue and the deer horn glue and mix them evenly, and then simmer for 20 minutes at 100℃ with small fire, and then naturally reduce to room temperature, and then add them into a pill making machine to obtain pills.

[0090] Example 4

[0091] A traditional Chinese medicine composition for treating vascular dementia, the following mass parts of traditional Chinese medicine formula raw materials are taken: Radix Rehmanniae Preparata 15 parts, Radix Dioscoreae 15 parts, Jiumu with wine 12 parts, Alisma orientale 12 parts, Poria cocos 12 parts, Cortex Moutan 12 parts, Ramulus Cinnamomi 12 parts, Bai Fupian 9 parts, Acorus gramineus 12 parts, Radix Polygalae 12 parts, Zhebeixu 12 parts, Tortoise Shell Glue 3 parts, Antler Glue 3 parts, Radix Hedysari 15 parts, Semen Litchi with salt 15 parts, Gastrodia 10 parts, Taxillus 15 parts, Salt Eucommia 15 parts. The medicine for treating vascular dementia in this Example 4 is granules, and the preparation method is the same as that in Example 1.

[0092] Example 5

[0093] A traditional Chinese medicine composition for treating vascular dementia, the following mass parts of traditional Chinese medicine formula raw materials are taken: Radix Rehmanniae Preparata 16 parts, Radix Dioscoreae 16 parts, Jiumu with wine 13 parts, Alisma orientale 13 parts, Poria cocos 13 parts, Cortex Moutan 13 parts, Ramulus Cinnamomi 13 parts, Bai Fupian 10 parts, Acorus gramineus 13 parts, Radix Polygalae 13 parts, Zhebeixu 13 parts, Tortoise Shell Glue 4 parts, Antler Glue 4 parts, Radix Hedysari 16 parts, Semen Litchi with salt 16 parts, Gastrodia 11 parts, Taxillus 16 parts, Salt Eucommia 16 parts. The medicine for treating vascular dementia in this Example 5 is pills, and the preparation method is the same as that in Example 2.

[0094] Example 6

[0095] A traditional Chinese medicine composition for treating vascular dementia, the following mass parts of traditional Chinese medicine formula raw materials are taken: Radix Rehmanniae Preparata 18 parts, Radix Dioscoreae 18 parts, Jiumu with wine 14 parts, Alisma orientale 14 parts, Poria cocos 14 parts, Cortex Moutan 14 parts, Ramulus Cinnamomi 14 parts, Bai Fupian 11 parts, Acorus gramineus 14 parts, Radix Polygalae 14 parts, Zhebeixu 14 parts, Tortoise Shell Glue 5 parts, Antler Glue 5 parts, Radix Hedysari 18 parts, Semen Litchi with salt 18 parts, Gastrodia 13 parts, Taxillus 18 parts, Salt Eucommia 18 parts. The medicine for treating vascular dementia in this Example 6 is paste, and the preparation method is the same as that in Example 3.

[0096] Example 7

[0097] A traditional Chinese medicine composition for treating vascular dementia, the following mass parts of traditional Chinese medicine formula raw materials are taken: Radix Rehmanniae Preparata 20 parts, Radix Dioscoreae 20 parts, Jiumu with wine 16 parts, Alisma orientale 16 parts, Poria cocos 16 parts, Cortex Moutan 16 parts, Ramulus Cinnamomi 16 parts, Bai Fupian 13 parts, Acorus gramineus 16 parts, Radix Polygalae 16 parts, Zhebeixu 16 parts, Tortoise Shell Glue 6 parts, Antler Glue 6 parts, Radix Hedysari 20 parts, Semen Litchi with salt 20 parts, Gastrodia 15 parts, Taxillus 20 parts, Salt Eucommia 20 parts. The medicine for treating vascular dementia in this Example 7 is granules, and the preparation method is the same as that in Example 1.

[0098] In order to verify the drug efficacy, the medicine prepared in Example 4 is used to identify the drug efficacy of the present application on patients with vascular dementia:

[0099] 1. Case source

[0100] The cases included in this study were from the outpatients of the Department of Encephalopathy of the First Affiliated Hospital of Henan University of Chinese Medicine from August 2022 to September 2024, a total of 200 patients who met the diagnostic criteria for vascular dementia with kidney essence deficiency syndrome were collected.

[0101] 2. Diagnostic criteria

[0102] 2.1 Western medicine diagnostic criteria

[0103] According to the 2019 China Neurology Association Cognitive Disorders Committee's 2019 China Guidelines for the Diagnosis and Treatment of Vascular Cognitive Impairment and the 2014 International Society for Vascular Behavior and Cognitive Impairment's 2014 VASCOG Consensus: Diagnostic Criteria for Vascular Cognitive Impairment:

[0104] (1) Cognitive impairment, mainly memory impairment in more than 2 cognitive domains, affecting daily life, but excluding other diseases that can cause cognitive or memory impairment (such as AD, psychosis, consciousness disorders, delirium, and other brain diseases;

[0105] (2) Cerebrovascular disease: neurological examination shows the presence of focal signs, and is consistent with stroke (whether or not there is a history of stroke);

[0106] (3) If there is no history of stroke, the impaired cognitive areas are mainly information processing speed, complex attention, and / or frontal lobe executive function;

[0107] (4) Cognitive impairment is related in time to one or more cerebrovascular events;

[0108] (5) Vascular damage plays a dominant role in cognitive impairment;

[0109] (6) Other brain diseases or other systemic diseases cannot better explain.

[0110] 2.2 Diagnostic criteria for traditional Chinese medicine

[0111] There is no disease name of vascular dementia in traditional Chinese medicine literature. According to its pathogenesis and clinical manifestations, it is classified into the category of "forgetfulness", "dull disease", "dementia" and other categories in traditional Chinese medicine. This study refers to the "Clinical Guidelines for New Drugs of Traditional Chinese Medicine for the Treatment of Senile Dementia" in the "Guidelines for Clinical Research of New Drugs of Traditional Chinese Medicine" in 2002, "Diagnosis, Syndrome Differentiation and Efficacy Criteria for Vascular Dementia" compiled by Tian Jinzhou and "New Century (Second Edition) National Higher Medical Colleges and Universities Planning Textbook · Internal Medicine of Traditional Chinese Medicine" to develop the diagnostic criteria for kidney essence deficiency type of this disease.

[0112] Main symptoms: mental decline, behavioral disorders, slow reaction, cold limbs, soreness of the waist and knees, clear or difficult urination, edema of the limbs, listlessness, and fatigue;

[0113] Secondary symptoms: cough with much phlegm, chest tightness, abdominal distension, and purple complexion or lips;

[0114] Tongue and pulse: purple tongue, large tongue with teeth marks on the edges, moist or thick and greasy tongue fur, and

[0115] slow and weak pulse, or thin and tight pulse, or slippery pulse.

[0116] The main symptoms have at least two, and the intelligence decline, behavioral disorders, and slow reaction have at least one, the secondary symptoms have two, and the diagnosis can be made in combination with the tongue and pulse.

[0117] 3. Inclusion and exclusion criteria

[0118] 3.1 Inclusion criteria

[0119] (1) 50 years ≤ age ≤ 80 years, men and women, clear consciousness, and can communicate in language;

[0120] (2) meet the above diagnostic criteria of VaD and TCM syndrome;

[0121] (3) Hachinski ischemic index (HIS) score > 7;

[0122] (4) CDR score belongs to mild to moderate dementia;

[0123] (5) 10 points ≤ MMSE score ≤ 26 points, among which the illiterate ≤ 17 points, primary school 20 points, middle school ≤ 22 points, and university ≤ 23 points;

[0124] (6) Mo CA score < 26;

[0125] (7) voluntarily participate in this test, and sign the informed consent form.

[0126] 3.2 Exclusion criteria

[0127] (1) patients with AD or other types of dementia caused by other reasons;

[0128] (2) patients with other serious primary diseases of the system;

[0129] (3) patients with serious heart, liver, kidney, tumor, and other diseases;

[0130] (4) patients who have used drugs that may affect cognitive function in recent period;

[0131] (5) patients participating in other studies at the same time;

[0132] (6) Patients with allergic constitution.

[0133] 3.3 Discontinuation criteria

[0134] (1) Patients with obvious or severe adverse reactions;

[0135] (2) Patients with severe adverse reactions after taking medicine or other serious complications during the test;

[0136] (3) Patients with poor compliance, unable to adhere to medication, self-medication or self-medication;

[0137] (4) Patients who cannot continue to take medicine due to their own reasons and voluntarily withdraw from the study.

[0138] 3.4 Dropout criteria and treatment

[0139] (1) Dropout criteria: patients who sign the informed consent, meet the inclusion and exclusion criteria, and fail to complete the required test period are considered as dropout cases.

[0140] (2) Treatment of dropout cases

[0141] ① Timely contact with patients through phone calls, online communication, door-to-door visits and other means to obtain as much relevant information as possible, understand the reasons in detail and make records;

[0142] ② Provide appropriate treatment measures for patients who withdraw due to drug allergy or adverse reactions;

[0143] ③ All relevant information and data of dropout patients are objectively recorded and properly stored.

[0144] 3.5 Exclusion criteria

[0145] After the case observation is completed, the main researcher will determine whether to exclude the case before statistical analysis of the data.

[0146] (1) Cases that do not meet the inclusion criteria but are mistakenly included;

[0147] (2) Patients with incomplete clinical data or death;

[0148] (3) Those who do not cooperate and withdraw from the study without reason.

[0149] 4. Observation index

[0150] Activities of daily living (ADL), clinical dementia rating scale (CDR) examination.

[0151] 5. Data analysis

[0152] SPSS 26.0 was used for statistical analysis. Measurement data were expressed as mean ± standard deviation. The data of each group were first subjected to homogeneity of variance test. Under the condition of normal distribution, the mean comparison between experimental groups was performed using one-way analysis of variance. The comparison between groups was performed using t-test or paired t-test. P<0.05 was considered statistically significant.

[0153] 6. Research plan

[0154] 50 patients meeting the diagnostic criteria were randomly selected and divided into a treatment group and a control group (random number table generated by Excel) at a ratio of 1:1.

[0155] (1) Control group: The Jinqi Shenqi Pill (Beijing Tong Ren Tang) was used for conventional treatment, with 20 pills taken twice a day in the morning and evening, for 8 weeks.

[0156] (2) Treatment group: The drug prepared in Example 4 was taken, with 1 portion of the granules prepared in Example 4 taken twice a day in the morning and evening, on an empty stomach, for 8 weeks.

[0157] 7. Research results

[0158] Table 1 Comparison of ADL scores before and after 8 weeks of treatment [M(P25, P75)]

[0159] Group Number of cases Before treatment After treatment Difference Z P Treatment group 25 25.52(18.00,31.00) 19.84 (15.00, 24.50) * ]] 5.68 (3.00, 9.00) △ ]] -4.379 ＜0.001 Control group 25 24.20(18.00,30.50) 23.12(17.00,29.50) 1.00(0.50,2.00) -3.788 ＜0.001 Z -0.117 -2.045 -5.280 P 0.907 0.041 ＜0.001

[0160] Note: *P<0.05 for comparison between the treatment group before and after treatment; P<0.05 for comparison of the difference after 8 weeks of treatment between the treatment group and the control group. △

[0161] Table 2 Comparison of CDR scores before and after 8 weeks of treatment [M(P25, P75)]

[0162] Group Number of cases Before treatment After treatment Difference Z P Treatment group 25 1.56(1.00,2.00) 1.00(1.00,1.00)* 0.50 (0.50, 1.00) △ ]] -4.187 ＜0.001 Control group 25 1.44(1.00,2.00) 1.30(1.00,2.00) 0.14(0.00,0.00) -1.890 0.059 Z -0.614 -3.849 -4.600 P 0.540 ＜0.001 ＜0.001

[0163] Note: *P<0.05 for comparison between the treatment group before and after treatment; P<0.05 for comparison of the difference after 8 weeks of treatment between the treatment group and the control group. △

[0164] ​​From the above table, it can be seen that the ADL score and CDR score of the patients in the treatment group and the control group before treatment have no statistical significance (P>0.05), and the patients in the two groups are comparable. After 8 weeks of treatment, whether the patients in the treatment group or the control group, the ADL score is obviously improved (P<0.05), but the CDR score of the control group has no obvious change, which indicates that after the treatment of the blood vessel dementia treating traditional Chinese medicine composition of the application, the intelligence state and the living ability of the patients with blood vessel dementia are obviously improved, and the Jinkui Shenqi Pill has some effect on the improvement of the living ability level, but it is not obvious for the improvement of memory. The ADL score and CDR score of the patients in the treatment group are obviously higher than those of the patients in the control group (P<0.05), and the comparison of the difference before and after indicates that the blood vessel dementia treating traditional Chinese medicine composition of the application can better improve the intelligence level of the patients with blood vessel dementia than the Jinkui Shenqi Pill, has a clear therapeutic effect on blood vessel dementia, and can be used for preparing a medicine for treating blood vessel dementia.

[0165] Typical cases:

[0166] Case 1: Jingsu, male, 74 years old, first diagnosed on August 11, 2022. Complaint: progressive intelligence decline for 1 month. Family members reported that the patient had suffered from cerebral infarction twice in recent years, and his intelligence declined 1 month ago. His face expression was dull, he could not calculate, he could not call the names of family members, he could walk independently, he dragged the ground when walking, he had incontinence of urine and stool, he choked when drinking water, his speech was unclear, his tongue was pale, his tongue fur was yellow and greasy, and his pulse was deep, fine and slippery. Western medical diagnosis: vascular dementia, TCM diagnosis: stroke dementia, syndrome of kidney essence deficiency, treat with warming and tonifying kidney yang, and awakening brain and opening orifice, orally take the granules prepared by the example 4 provided in the application, 1 dose per day, take 2 times a day. After 1 week of taking the medicine, the patient's condition was obviously relieved, his face expression was rich, his reaction was more sensitive than before, he could answer the questions correctly, he could say the names of family members, his calculation ability was improved, the dragging of the ground when walking was obviously reduced, the incontinence of urine and stool, and the choking when drinking water were obviously reduced, his speech was clear, his tongue was dark red, his tongue fur was yellow and thick, and his pulse was deep, fine and slippery.

[0167] Case 2: Liusu, male, 52 years old, first diagnosed on January 7, 2023. Complaint: memory decline for more than 1 month. The patient had a history of hypertension for many years, and suffered from cerebral infarction 1 month ago, and then had memory decline, got lost outside, had slow reaction, had increased nocturia, 2-3 times per night, had normal food intake and sleep, his tongue was pale, his tongue fur was white and thick, and his pulse was stringy and slippery. Western medical diagnosis: vascular dementia. TCM diagnosis: stroke dementia, kidney essence deficiency syndrome. Principle of treatment: tonifying liver and kidney, resolving phlegm and blood stasis, and dredging brain orifices. Orally take the granules prepared by the example 4 provided in the application, 1 dose per day, take 2 times a day. After 2 weeks of taking the medicine, the patient's memory was obviously improved, he did not get lost again, his reaction was more sensitive than before, his nocturia was reduced, 1-2 times per night, he had normal food intake and sleep, his tongue was pale, his tongue fur was yellow and thick, and his pulse was stringy and slippery.

[0168] The above merely describes the preferred embodiments of the present application and is not used to limit the present application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A traditional Chinese medicine composition for treating vascular dementia, characterized in that, By weight, it is composed of the following raw medicinal materials: 10-20 parts Rehmannia glutinosa (processed), 10-20 parts Dioscorea opposita, 8-16 parts Cornus officinalis (processed with wine), 8-16 parts Alisma plantago-aquatica, 8-16 parts Poria cocos, 8-16 parts Paeonia suffruticosa, 8-16 parts Cinnamomum cassia, 5-13 parts Aconitum carmichaelii (processed), 8-16 parts Acorus tatarinowii, 8-16 parts Polygala tenuifolia (processed), 8-16 parts Curcuma longa (processed with vinegar), 1-6 parts Tortoise shell glue, 1-6 parts Deer antler glue, 10-20 parts Achyranthes bidentata, 10-20 parts Cuscuta chinensis (processed with salt), 5-15 parts Gastrodia elata, 10-20 parts Taxillus chinensis, and 10-20 parts Eucommia ulmoides (processed with salt).

2. The traditional Chinese medicine composition for treating vascular dementia according to claim 1, characterized in that, By weight, it is composed of the following raw medicinal materials: 12-18 parts of Rehmannia glutinosa (processed), 12-18 parts of Dioscorea opposita, 10-14 parts of Cornus officinalis (processed with wine), 10-14 parts of Alisma plantago-aquatica, 10-14 parts of Poria cocos, 10-14 parts of Paeonia suffruticosa, 10-14 parts of Cinnamomum cassia, 7-11 parts of Aconitum carmichaelii (processed with wine), 10-14 parts of Acorus tatarinowii, 10-14 parts of Polygala tenuifolia (processed with wine), 10-14 parts of Curcuma longa (processed with vinegar), 2-5 parts of tortoise shell glue, 2-5 parts of deer antler glue, 12-18 parts of Achyranthes bidentata, 12-18 parts of Cuscuta chinensis (processed with salt), 7-13 parts of Gastrodia elata, 12-18 parts of Taxillus chinensis, and 12-18 parts of Eucommia ulmoides (processed with salt).

3. The traditional Chinese medicine composition for treating vascular dementia according to claim 1, characterized in that, By weight, it is composed of the following raw medicinal materials: 14-16 parts Rehmannia glutinosa (processed), 14-16 parts Dioscorea opposita, 11-13 parts Cornus officinalis (processed with wine), 11-13 parts Alisma plantago-aquatica, 11-13 parts Poria cocos, 11-13 parts Paeonia suffruticosa, 11-13 parts Cinnamomum cassia, 8-10 parts Aconitum carmichaelii (processed), 11-13 parts Acorus tatarinowii, 11-13 parts Polygala tenuifolia (processed), 11-13 parts Curcuma longa (processed with vinegar), 3-4 parts Tortoise shell glue, 3-4 parts Deer antler glue, 14-16 parts Achyranthes bidentata, 14-16 parts Cuscuta chinensis (processed with salt), 9-11 parts Gastrodia elata, 14-16 parts Taxillus chinensis, and 14-16 parts Eucommia ulmoides (processed with salt).

4. The use of the traditional Chinese medicine composition for treating vascular dementia according to any one of claims 1 to 3 in the preparation of a medicament for treating vascular dementia.

5. A drug for treating vascular dementia, characterized in that, It is made from the traditional Chinese medicine composition for treating vascular dementia as described in any one of claims 1 to 3 and pharmaceutically acceptable excipients.

6. The medicament for treating vascular dementia according to claim 5, characterized in that, The dosage form of the drug is a traditional Chinese medicine decoction, granule, pill, capsule, tablet, tea, suspension, powder, or oral liquid.

7. The method for preparing the medicament for treating vascular dementia according to claim 6, characterized in that, The drug is in granule form, and its preparation method is as follows: Step 1: Weigh out the raw materials (excluding tortoise shell glue and deer antler glue) according to the weight ratio, clean, dry, cut, crush, sieve, and mix evenly; Step 2: Add water to cover the raw materials taken in Step 1 by 1-3 cm and soak for 30-50 minutes. Then bring to a boil over high heat, then simmer over low heat for 50-70 minutes. Filter using a Chinese medicine sieve to obtain the first filtrate. Add water to the dregs to cover them, bring to a boil over high heat, then simmer over low heat for 50-70 minutes. Filter out the dregs using a Chinese medicine sieve to obtain the second filtrate. Combine the first and second filtrates. Step 3: Add tortoise shell glue and deer antler glue to the combined filtrate from Step 2 and mix well. Place the mixture in a vacuum dryer and dry it at a temperature of 40-60℃ and a pressure of 5-6KPa until the weight no longer decreases, thus preparing granules.

8. The method for preparing the medicament for treating vascular dementia according to claim 6, characterized in that, The drug is in the form of pills, and its preparation method is as follows: Step 1: Weigh out the raw materials (excluding tortoise shell glue and deer antler glue) according to the weight ratio, clean, dry, cut, crush, sieve, and mix evenly; Step 2: Add water to cover the raw materials obtained in Step 1 by 1-3 cm and soak for 30-50 minutes. Then bring to a boil over high heat, and then simmer over low heat for 50-70 minutes. Filter using a Chinese medicine sieve to obtain the first filtrate. Add water to the dregs to cover them, bring to a boil over high heat, and then simmer over low heat for 50-70 minutes. Filter out the dregs using a Chinese medicine sieve to obtain the second filtrate. Combine the first and second filtrates and place them in a vacuum dryer at a temperature of 40-60℃ and a pressure of 5-6 kPa until the weight no longer decreases. Step 3: Heat the honey to 100-120℃, then mix it with the dried medicine from Step 2 at a mass ratio of 1:1.

2. Add tortoise shell glue and deer antler glue and mix well. Simmer over low heat at 100-120℃ for 15-25 minutes, then let it cool to room temperature before adding it to a pill-making machine to obtain pills.

9. The method for preparing the medicament for treating vascular dementia according to claim 6, characterized in that, The drug is an ointment, and its preparation method is as follows: Step 1: Weigh out the raw materials (excluding tortoise shell glue and deer antler glue) according to the weight ratio, clean, dry, cut, crush, sieve, and mix evenly; Step 2: Add water to cover the raw materials obtained in Step 1 by 1-3 cm and soak for 30-50 minutes. Then bring to a boil over high heat, and then simmer over low heat for 50-70 minutes. Filter using a Chinese medicine sieve to obtain the first filtrate. Add water to the dregs to cover them, bring to a boil over high heat, and then simmer over low heat for 50-70 minutes. Filter out the dregs using a Chinese medicine sieve to obtain the second filtrate. Combine the first and second filtrates and place them in a vacuum dryer at a temperature of 40-60℃ and a pressure of 5-6 kPa until the weight no longer decreases. Step 3: Heat the honey to 100-120℃, then mix it with the dried medicine from Step 2, honey, and water in a mass ratio of 1:1.2:

2. Add tortoise shell glue and deer antler glue and mix well. Simmer over low heat at 100-120℃, stirring constantly. When the medicine reaches the "hanging flag" stage, pour the ointment into a dry container to obtain the ointment.