Traditional Chinese medicine composition for treating vascular dementia as well as preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating vascular dementia and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine, the traditional Chinese medicine composition comprises the following raw medicinal materials: prepared rehmannia root, Chinese yam, wine-processed fructus corni, rhizoma alismatis, poria cocos, moutan bark, cassia twig, prepared common monkshood daughter root, rhizoma acori graminei, prepared polygala tenuifolia, vinegar-processed radix curcumae, tortoise-shell glue, deer-horn glue, achyranthes bidentata, salt-processed semen cuscutae, gastrodia elata, parasitic loranthus and salt-processed eucommia ulmoides; the invention further discloses a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition has the beneficial effects that the kidney-qi pill is taken as a basic formula, and the traditional Chinese medicine theory is combined, so that the brand-new traditional Chinese medicine composition for treating vascular dementia is obtained. The traditional Chinese medicine composition can obviously improve the symptoms of intelligence decline, thinking retardation and the like of vascular dementia patients, effectively delay the rapid progress of the disease course, and provide a new treatment choice for the vascular dementia patients.

Description

Technical Field

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

[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 cerebrovascular obstruction, 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, particularly those responsible for higher cognitive functions such as memory, learning, and thinking. Vascular dementia is particularly common among the elderly and is considered the second leading cause of age-related dementia, second only to the well-known Alzheimer's disease in incidence.

[0003] Despite significant progress in the study of vascular dementia, effective medications for this condition remain lacking. Therefore, early detection, diagnosis, and treatment are crucial strategies for managing vascular dementia. Prevention is particularly crucial, encompassing both primary and secondary prevention, which aims to reduce the risk of vascular dementia by controlling risk factors such as hypertension and diabetes, as well as promptly treating cerebrovascular disease.

[0004] In terms of drug treatment, cholinesterase inhibitors and memantine are currently 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 the treatment of vascular dementia require further research. This means that although they are used in clinical practice to some extent, their therapeutic efficacy and safety still need to be further evaluated.

[0005] Meanwhile, Traditional Chinese Medicine (TCM) has demonstrated unique advantages in the clinical treatment of vascular dementia in my country. Traditional Chinese medicine (TCM) theory posits that the onset of dementia is closely linked to insufficient kidney qi and insufficient essence and marrow. With aging, kidney qi gradually declines, preventing the essence and marrow from adequately nourishing the brain, leading to symptoms such as memory loss and slowed thinking. Ancient physicians such as Sun Simiao have long argued that the gradual depletion of kidney qi and the resulting emptiness of the brain marrow in the elderly are one of the main causes of dementia. Based on this theory, TCM treatments for dementia often focus on tonifying the kidneys, with Shenqi Wan (Ken Qi Wan) being a representative formula. This formula, composed of tonic herbs such as dried Rehmannia root, Cornus officinalis, and Chinese yam, primarily nourishes kidney essence and qi. Furthermore, herbs such as Alisma orientalis, Poria cocos, and Cortex Moutan are incorporated to dissipate dampness and purge heat, preventing these tonic herbs from becoming overly nourishing and potentially blocking the Qi flow. Furthermore, small amounts of cinnamon twig and aconite root are added to warm and tonify kidney yang, subtly generating internal heat and promoting the production of kidney qi. This combination of tonic and purgative properties, and tonic without being greasy, allows Shenqi Pills to nourish the kidneys while taking into account the balance and harmony of the body.

[0006] In view of this, the inventor conducted in-depth research on this demand, and thus came up with this case. Summary of the Invention

[0007] Existing technology demonstrates that Shenqi Pills can improve cognitive impairment-like behaviors and exhibit excellent clinical safety and efficacy in treating vascular dementia. However, long-term clinical observations have revealed that elderly patients with kidney deficiency-type vascular dementia experience severe kidney essence deficiency, making Shenqi Pills' kidney-tonifying effects slow. Furthermore, elderly individuals often experience weak Qi and blood, with phlegm and blood stasis blocking the meridians, obscuring the clear orifices, leading to phlegm and blood stasis obscuring the orifices and slowing reactions. Furthermore, some patients experience kidney Qi deficiency and loss of kidney essence, resulting in soreness in the waist and knees, urinary incontinence, or increased nocturia.

[0008] In response to the above technical problems, the specific technical solutions of this application are as follows:

[0009] A traditional Chinese medicine composition for treating vascular dementia comprises the following raw medicinal materials: prepared rehmannia root, yam, wine-soaked cornus fruit, oriental water rhizome, tuckahoe, moutan bark, cinnamon twig, aconite root, calamus gramineus, processed polygala root, vinegar-soaked turmeric, tortoise shell glue, antler glue, achyranthes bidentata, salt dodder seed, gastrodia elata, mistletoe and salt eucommia.

[0010] Preferably, the raw medicinal materials are included, by mass: 10-20 parts of Rehmannia root, 10-20 parts of Chinese yam, 8-16 parts of cornus fruit, 8-16 parts of Alisma orientalis, 8-16 parts of Poria cocos, 8-16 parts of Paeonia suffruticosa, 8-16 parts of cinnamon twig, 5-13 parts of Radix Aconiti Lateralis Preparata, 8-16 parts of Acorus gramineus, 8-16 parts of processed Polygala tenuifolia, 8-16 parts of vinegar turmeric, 1-6 parts of tortoise shell glue, 1-6 parts of antler glue, 10-20 parts of Achyranthes bidentata, 10-20 parts of salt Cuscuta seed, 5-15 parts of Gastrodia elata, 10-20 parts of Morus parasiticus, and 10-20 parts of salt Eucommia ulmoides.

[0011] Preferably, the raw medicinal materials are included, by mass: 12-18 parts of Rehmannia root, 12-18 parts of Chinese yam, 10-14 parts of cornus fruit, 10-14 parts of Alisma orientalis, 10-14 parts of Poria cocos, 10-14 parts of Paeonia suffruticosa, 10-14 parts of cinnamon twig, 7-11 parts of Radix Aconiti Lateralis Preparata, 10-14 parts of Acorus calamus, 10-14 parts of processed Polygala tenuifolia, 10-14 parts of vinegar-curcuma, 2-5 parts of tortoise shell glue, 2-5 parts of antler glue, 12-18 parts of Achyranthes bidentata, 12-18 parts of salt Cuscuta chinensis, 7-13 parts of Gastrodia elata, 12-18 parts of Morus parasiticus, and 12-18 parts of salt Eucommia ulmoides.

[0012] Preferably, the raw medicinal materials are included, by mass: 14-16 parts of Rehmannia root, 14-16 parts of Chinese yam, 11-13 parts of cornus fruit, 11-13 parts of Alisma orientalis, 11-13 parts of Poria cocos, 11-13 parts of Paeonia suffruticosa, 11-13 parts of cinnamon twig, 8-10 parts of Radix Aconiti Lateralis Preparata, 11-13 parts of Acorus calamus, 11-13 parts of processed Polygala tenuifolia, 11-13 parts of vinegar-curcuma, 3-4 parts of tortoise shell glue, 3-4 parts of antler glue, 14-16 parts of Achyranthes bidentata, 14-16 parts of salt Cuscuta chinensis, 9-11 parts of Gastrodia elata, 14-16 parts of Morus parasiticus, and 14-16 parts of salt Eucommia ulmoides.

[0013] Preferably, the raw medicinal materials are included, by mass: 15 parts of Rehmannia root, 15 parts of Chinese yam, 12 parts of cornus fruit, 12 parts of Alisma orientalis, 12 parts of Poria, 12 parts of Paeonia suffruticosa, 12 parts of cinnamon twig, 9 parts of Radix Aconiti Lateralis Preparata, 12 parts of Acorus gramineus, 12 parts of processed Polygala tenuifolia, 12 parts of vinegar turmeric, 3 parts of tortoise shell glue, 3 parts of antler glue, 15 parts of Achyranthes bidentata, 15 parts of salt dodder seeds, 10 parts of Gastrodia elata, 15 parts of mistletoe, and 15 parts of salt Eucommia ulmoides.

[0014] Preferably, the tortoise shell glue and the deer antler glue both need to be melted in traditional Chinese medicine before being used as medicine.

[0015] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition for treating vascular dementia in preparing medicine for treating vascular dementia.

[0016] The present invention also provides a medicine for treating vascular dementia, comprising the above-mentioned traditional Chinese medicine composition for treating vascular dementia and pharmaceutically acceptable excipients.

[0017] Preferably, the dosage form of the drug is a traditional Chinese medicine decoction, decoction, granules, pills, capsules, tablets, tea, suspension, powder or oral solution.

[0018] The present invention also provides a method for preparing the above-mentioned drug for treating vascular dementia. When the drug is a granule, the preparation method is as follows:

[0019] Step 1: weigh the raw materials except tortoise shell glue and deer antler glue according to the weight ratio, select, dry, cut, crush, sieve, and mix evenly;

[0020] Step 2: adding water to cover the raw material drug obtained in step 1 by 1 to 3 cm and soaking for 30 to 50 minutes, then boiling over high heat, then decocting over low heat for 50 to 70 minutes, and filtering through a Chinese medicine sieve to obtain a first filtrate; then adding water to cover the drug residue, boiling over high heat, then decocting over low heat for 50 to 70 minutes, and filtering through a Chinese medicine sieve to remove the drug residue to obtain a second filtrate; combining the first filtrate and the second filtrate;

[0021] Step three, add tortoise shell glue and deer antler glue to the combined filtrate in step two, mix evenly, place in a vacuum dryer, and dry at a temperature of 40-60° C. and a pressure of 5-6 KPa until the weight no longer decreases, to obtain granules.

[0022] The present invention also provides a method for preparing the above-mentioned drug for treating vascular dementia, wherein the drug is a pill, and the preparation method thereof is as follows:

[0023] Step 1: weigh the raw materials except tortoise shell glue and deer antler glue according to the weight ratio, select, dry, cut, crush, sieve, and mix evenly;

[0024] Step 2: adding water to cover the raw material drug obtained in step 1 by 1 to 3 cm and soaking it for 30 to 50 minutes, then boiling it with high heat, then decocting it with low heat for 50 to 70 minutes, and filtering it with a Chinese medicine sieve to obtain a first filtrate; then adding water to cover the slag, boiling it with high heat, then decocting it with low heat for 50 to 70 minutes, and filtering the slag with a Chinese medicine sieve to obtain a second filtrate; combining the first filtrate and the second filtrate, placing it in a vacuum dryer, and drying it at a temperature of 40 to 60° C. and a pressure of 5 to 6 kPa until the weight no longer decreases;

[0025] Step three, heat the honey to 100-120°C, then mix it evenly with the dry medicine and honey in step two in a mass ratio of 1:1.2, then add tortoise shell glue and deer antler glue and mix evenly, simmer on low heat at 100-120°C for 15-25 minutes, then naturally cool to room temperature and add it to a pill making machine to obtain pills.

[0026] The present invention also provides a method for preparing the above-mentioned drug for treating vascular dementia, wherein the drug is an ointment, and the preparation method thereof is as follows:

[0027] Step 1: weigh the raw materials except tortoise shell glue and deer antler glue according to the weight ratio, select, dry, cut, crush, sieve, and mix evenly;

[0028] Step 2: adding water to cover the raw material drug obtained in step 1 by 1 to 3 cm and soaking it for 30 to 50 minutes, then boiling it with high heat, then decocting it with low heat for 50 to 70 minutes, and filtering it with a Chinese medicine sieve to obtain a first filtrate; then adding water to cover the slag, boiling it with high heat, then decocting it with low heat for 50 to 70 minutes, and filtering the slag with a Chinese medicine sieve to obtain a second filtrate; combining the first filtrate and the second filtrate, placing it in a vacuum dryer, and drying it at a temperature of 40 to 60° C. and a pressure of 5 to 6 kPa until the weight no longer decreases;

[0029] Step three, heat the honey to 100-120°C, then mix it evenly with the dry medicine in step two, honey and water in a mass ratio of 1:1.2:2, then add tortoise shell glue and deer antler glue and mix evenly, simmer over low heat at 100-120°C and stir continuously, and when the medicine is cooked, pour the ointment into a dry container to obtain the ointment.

[0030] The beneficial effects produced by the technical solution of the present invention are as follows:

[0031] The Chinese medicine composition provided by the present invention uses Rehmannia root, cinnamon twig, tortoise shell glue, and antler glue as the main ingredients, which are effective in tonifying the kidney and brain. Rehmannia root is flat in nature, sweet and warm, and can tonify the kidney and promote kidney function, and can replenish the true yin of the five internal organs. Cinnamon twig is pungent, sweet and warm, warms and promotes yang energy, tonifies kidney yang, and helps qi transformation. Both tortoise and deer glue are products with blood and flesh. Deer antler is sweet, salty and slightly warm, and can open the Governor Vessel and warm and tonify yang. Turtle shell is sweet, salty and cold, and can open the Ren Vessel and replenish yin essence. The four main ingredients are combined to tonify yin and yang to generate qi and blood essence. Radix Aconiti Lateralis Preparata, Chinese yam, wine-infused cornus fruit, mistletoe, salt eucommia bark, and dodder seed are the auxiliary ingredients. Among them, Radix Aconiti Lateralis Preparata and dodder seed can warm the kidney, benefit essence and transform qi, and enhance the warming and unblocking effect of deer antler. Chinese yam and wine-infused cornus fruit can help the main ingredient to tonify kidney essence, tonify the spleen and lungs, and strengthen the acid to prevent hair loss. Mulberry leaf and salt eucommia bark can help Rehmannia root to tonify the liver and kidney, and strengthen the waist and knees. Acorus calamus, Curcuma aromatica, and Polygala tenuifolia are added to resolve phlegm, invigorate the mind, and improve intelligence. Gastrodia elata strengthens the kidney's yang energy and unclogs the blood vessels. Paeonia suffruticosa suffruticosa clears heat and activates blood circulation, Poria cocos strengthens the spleen and eliminates dampness, and Alisma orientalis clears turbidity and relieves heat, preventing the accumulation of numerous tonic ingredients that can lead to dampness and heat. Achyranthes bidentata acts as a guide, guiding the other herbs to move downward, targeting the liver and kidneys. Taken together, the entire formula nourishes the kidney's qi, blood, and essence, while also invigorating the mind, regulating qi, and unblocking the meridians. This multifaceted approach improves the clinical symptoms of patients with kidney deficiency-type vascular dementia and significantly enhances their quality of life.

[0032] In addition, the Chinese medicine composition provided by the present invention adopts natural Chinese medicine for treatment, and has a stronger and more specific effect of replenishing kidney qi and benefiting essence, and can also open up the orifices and refresh the mind, regulate qi and dredge the meridians, and can improve common symptoms of vascular dementia patients such as memory loss, abnormal urination, chills and cold limbs, and discomfort in the waist and knees. The invention also provides a preparation method for a variety of drug dosage forms suitable for the prescription, which can be flexibly selected by patients with vascular dementia, thereby enhancing the convenience of taking the medicine, facilitating patients to adhere to the drug treatment, and enhancing the efficacy. DETAILED DESCRIPTION

[0033] In order to make the purpose, 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 part of the embodiments of the present invention, rather than all the embodiments. Therefore, the following detailed description of the embodiments provided by the present invention is not intended to limit the scope of the invention claimed for protection, but merely represents the selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0034] This embodiment fully analyzes that elderly patients with kidney deficiency type vascular dementia have more severe kidney essence deficiency, and the kidney-tonifying effect of Shenqi Pills is slow; secondly, people in old age often have weak qi and blood, phlegm and blood stasis block the meridians, and the clear orifices are obscured, resulting in phlegm and blood stasis blocking the orifices and slow reaction; and some patients have kidney qi deficiency and loose kidney essence, resulting in soreness of the waist and knees, urinary incontinence or increased nocturia, and invented a traditional Chinese medicine composition for treating vascular dementia and its preparation method and application, including the following raw medicinal materials: prepared rehmannia, yam, wine-soaked cornus fruit, oriental water chestnut, poria, moutan bark, cinnamon twig, aconite root, calamus, processed polygala, vinegar turmeric, tortoise shell glue, antler glue, Achyranthes bidentata, salt dodder seed, gastrodia elata, mistletoe and salt ulmoides.

[0035] In the Chinese medicine composition for treating vascular dementia provided in this application:

[0036] Rehmannia root (Shui Di Huang): Sweet in flavor, slightly warm in nature, it enters the liver and kidney meridians. It nourishes blood and yin, replenishes essence and marrow. It is primarily used to treat blood deficiency, sallow complexion, palpitations, irregular menstruation, metrorrhagia, liver and kidney yin deficiency, soreness of the waist and knees, hot flashes, night sweats, spermatorrhea, internal heat and thirst, dizziness, tinnitus, and premature graying of hair.

[0037] Chinese Yam: Sweet in flavor, neutral in nature, it enters the spleen, lung, and kidney meridians. It nourishes the spleen and stomach, promotes fluid production and benefits the lungs, and tonifies the kidneys and astringes semen. It is primarily used to treat spleen deficiency, poor appetite, chronic diarrhea, wheezing and coughing due to lung deficiency, spermatorrhea due to kidney deficiency, leukorrhea, frequent urination, and heat-induced thirst.

[0038] Wine-infused Cornus officinalis: Sour, astringent, and slightly warm in nature, it enters the Liver and Kidney meridians. It nourishes the liver and kidneys, and has astringent and firming properties. It is used to treat soreness of the waist and knees, dizziness, tinnitus, impotence, spermatorrhea, enuresis, frequent urination, metrorrhagia, leukorrhea, profuse sweating, and internal heat and thirst.

[0039] Alisma: Sweet and light in flavor, cold in nature, it enters the kidney and bladder meridians. It promotes diuresis, dissipates heat, and clears turbidity and reduces lipids. It is primarily used to treat dysuria, edema, diarrhea, oliguria, phlegm and fluid retention, dizziness, painful stranguria caused by heat, and hyperlipidemia.

[0040] Poria cocos: Sweet and bland in flavor, neutral in nature, it enters the Heart, Lung, Spleen, and Kidney meridians. It promotes diuresis, dissipates dampness, strengthens the spleen, and calms the mind. It is primarily used to treat edema, oliguria, phlegm and fluid retention, dizziness and palpitations, spleen deficiency, poor appetite, loose stools and diarrhea, restlessness, palpitations, and insomnia.

[0041] Moutan Bark: Bitter and pungent in flavor, slightly cold in nature, it enters the Heart, Liver, and Kidney meridians. It clears heat, cools blood, and promotes blood circulation and removes blood stasis. It is used to treat fever caused by toxic heat, vomiting and epistaxis due to blood heat, Yin damage due to febrile diseases, fever due to Yin deficiency, nighttime fever and morning chills, dryness due to bone steaming, amenorrhea, dysmenorrhea, accumulation of lumps and masses, and pain from falls.

[0042] Cinnamon twig: Pungent and sweet in flavor, warm in nature, it enters the Heart, Lung, and Bladder meridians. It has the effects of inducing sweating and relieving muscle tension, warming and unblocking the meridians, and promoting yang and transforming qi. It is mainly used to treat colds, abdominal pain caused by cold blood, amenorrhea, joint pain, phlegm and fluid retention, edema, and palpitations.

[0043] Danfu Pian (a product of Aconite): Pungent and sweet in flavor, highly warm in nature, it enters the Heart, Kidney, and Spleen meridians. It has the effects of restoring Yang, tonifying Fire and supporting Yang, and dispelling cold and relieving pain. It is primarily used to treat Yang deficiency and collapse, cold limbs and weak pulse, heart Yang deficiency, chest pain and heartache, vomiting and diarrhea due to deficiency-cold, cold and painful epigastric area, kidney Yang deficiency, impotence and uterine coldness, edema due to Yin-cold, exogenous infection caused by Yang deficiency, and pain due to cold-dampness.

[0044] Acorus calamus: Pungent and bitter in flavor, warm in nature, it enters the Heart and Stomach meridians. It has the effects of opening the orifices and dispelling phlegm, refreshing the mind and improving intelligence, and removing dampness and stimulating the appetite. It is mainly used to treat phlegm obstructing the orifices, coma, epilepsy, forgetfulness, insomnia, tinnitus, deafness, abdominal distension without hunger, dysentery due to muteness, and dampness and turbidity in the middle of the body.

[0045] Processed Polygala tenuifolia: Same as Polygala tenuifolia, but processed may enhance its calming, intellectual, and expectorant effects, and reduce certain side effects.

[0046] Vinegar Curcuma: Pungent and bitter in flavor, cold in nature, it enters the Liver, Heart, and Lung meridians. It promotes blood circulation and relieves pain, promotes qi and relieves depression, clears the heart and cools the blood, and promotes bile secretion and reduces jaundice. It is used to treat chest and flank pain, chest pain, dysmenorrhea, amenorrhea, breast tenderness, coma due to febrile illness, epilepsy, vomiting and epistaxis due to blood heat, and jaundice and dark urine.

[0047] Turtle Shell Glue: Sweet and salty in flavor, neutral in nature, it enters the Liver, Kidney, and Heart meridians. It nourishes Yin and blood, and stops bleeding. It is used to treat Yin deficiency-induced hot flashes, bone steaming and night sweats, dizziness, internal wind movement, weakness of muscles and bones, heart deficiency and forgetfulness, and metrorrhagia and leukorrhea.

[0048] Deer Antler Glue: Sweet and salty in flavor, warm in nature, it enters the kidney and liver meridians. It warms and nourishes the liver and kidneys, replenishes essence and blood. It is used to treat impotence, spermatorrhea, soreness and coldness in the waist and knees, consumptive emaciation, metrorrhagia, bloody stools, hematuria, and genital sores.

[0049] Achyranthes bidentata: Bitter, sweet, and sour in flavor, it is neutral in nature and enters the Liver and Kidney meridians. It has the effects of removing blood stasis, tonifying the liver and kidneys, strengthening tendons and bones, promoting urination and relieving stranguria, and guiding blood downward. It is mainly used to treat amenorrhea due to blood stasis, dysmenorrhea, abdominal pain during menstruation, retained placenta, traumatic injuries, soreness of the waist and knees, lower limb weakness, stranguria, edema, dysuria, dizziness, mouth sores, hematemesis, and epistaxis.

[0050] Salt Cuscuta Seed: Spicy and sweet, neutral in nature, it enters the Liver, Kidney, and Spleen meridians. It nourishes the kidneys and replenishes essence, nourishes the liver and improves eyesight, and strengthens the spleen and stops diarrhea. It is used to treat soreness of the waist and knees, impotence, spermatorrhea, enuresis, frequent urination, blurred vision, tinnitus, and diarrhea caused by spleen and kidney deficiency.

[0051] Gastrodia elata: Sweet in flavor, neutral in nature, enters the Liver meridian. It calms wind and convulsions, calms liver yang, and dispels wind and dredges the meridians. It is used to treat infantile convulsions, epilepsy, tetanus, headache, dizziness, paralysis of hands and feet, numbness of limbs, and rheumatic pain.

[0052] Mulberry parasite: Bitter and sweet in flavor, neutral in nature, it enters the liver and kidney meridians. It dispels rheumatism, nourishes the liver and kidneys, strengthens the bones and tendons, and stabilizes the fetus. It is primarily used to treat rheumatic pain, soreness of the waist and knees, weakness of the bones and tendons, heavy metrorrhagia, bleeding during pregnancy, and restless fetuses.

[0053] Salted Eucommia: Sweet, slightly spicy, and warm in nature, it enters the Liver and Kidney meridians. It nourishes the liver and kidneys, strengthens the bones and tendons, and stabilizes pregnancy. It is primarily used to treat kidney deficiency and other low back pain, fetal restlessness, and habitual abortion. Salting further enhances its kidney-tonifying properties.

[0054] As a preferred embodiment, the invention comprises the following raw medicinal materials in parts by mass: 10-20 parts of Rehmannia root, 10-20 parts of Chinese yam, 8-16 parts of cornus fruit, 8-16 parts of Alisma orientalis, 8-16 parts of Poria cocos, 8-16 parts of Paeonia suffruticosa, 8-16 parts of cinnamon twig, 5-13 parts of Radix Aconiti Lateralis Preparata, 8-16 parts of Acorus gramineus, 8-16 parts of processed Polygala tenuifolia, 8-16 parts of vinegar turmeric, 1-6 parts of tortoise shell glue, 1-6 parts of antler glue, 10-20 parts of Achyranthes bidentata, 10-20 parts of salt dodder seed, 5-15 parts of Gastrodia elata, 10-20 parts of mistletoe, and 10-20 parts of salt Eucommia ulmoides.

[0055] As a preferred embodiment, the invention comprises the following raw medicinal materials in parts by mass: 12-18 parts of Rehmannia root, 12-18 parts of Chinese yam, 10-14 parts of cornus fruit, 10-14 parts of Alisma orientalis, 10-14 parts of Poria cocos, 10-14 parts of Paeonia suffruticosa, 10-14 parts of cinnamon twig, 7-11 parts of Radix Aconiti Lateralis Preparata, 10-14 parts of Acorus calamus, 10-14 parts of processed Polygala tenuifolia, 10-14 parts of vinegar turmeric, 2-5 parts of tortoise shell glue, 2-5 parts of antler glue, 12-18 parts of Achyranthes bidentata, 12-18 parts of salt dodder seed, 7-13 parts of Gastrodia elata, 12-18 parts of mistletoe, and 12-18 parts of salt Eucommia ulmoides.

[0056] As a preferred embodiment, the invention comprises the following raw medicinal materials in parts by mass: 14-16 parts of Rehmannia root, 14-16 parts of Chinese yam, 11-13 parts of cornus fruit, 11-13 parts of Alisma orientalis, 11-13 parts of Poria cocos, 11-13 parts of Paeonia suffruticosa, 11-13 parts of cinnamon twig, 8-10 parts of Radix Aconiti Lateralis Preparata, 11-13 parts of Acorus calamus, 11-13 parts of processed Polygala tenuifolia, 11-13 parts of vinegar turmeric, 3-4 parts of tortoise shell glue, 3-4 parts of antler glue, 14-16 parts of Achyranthes bidentata, 14-16 parts of salt Cuscuta seed, 9-11 parts of Gastrodia elata, 14-16 parts of Morus parasiticus, and 14-16 parts of salt Eucommia ulmoides.

[0057] As a preferred embodiment, the invention comprises the following raw medicinal materials in parts by mass: 15 parts of Rehmannia root, 15 parts of Chinese yam, 12 parts of cornus fruit, 12 parts of Alisma orientalis, 12 parts of Poria cocos, 12 parts of Paeonia suffruticosa, 12 parts of cinnamon twig, 9 parts of Radix Aconiti Lateralis Preparata, 12 parts of Acorus gramineus, 12 parts of processed Polygala tenuifolia, 12 parts of vinegar turmeric, 3 parts of tortoise shell glue, 3 parts of antler glue, 15 parts of Achyranthes bidentata, 15 parts of salt dodder seed, 10 parts of Gastrodia elata, 15 parts of mistletoe, and 15 parts of salt Eucommia ulmoides.

[0058] As a preferred embodiment, the tortoise shell glue and the deer antler glue both need to be melted in traditional Chinese medicine before being used as medicine.

[0059] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition for treating vascular dementia in preparing medicine for treating vascular dementia.

[0060] The present invention also provides a medicine for treating vascular dementia, comprising the above-mentioned traditional Chinese medicine composition for treating vascular dementia and pharmaceutically acceptable excipients.

[0061] As a preferred embodiment, the dosage form of the drug is a traditional Chinese medicine decoction, decoction, granules, pills, capsules, tablets, tea, suspension, powder or oral liquid.

[0062] The present invention also provides a method for preparing the above-mentioned drug for treating vascular dementia. When the drug is a granule, the preparation method is as follows:

[0063] Step 1: weigh the raw materials except tortoise shell glue and deer antler glue according to the weight ratio, select, dry, cut, crush, sieve, and mix evenly;

[0064] Step 2: adding water to cover the raw material drug obtained in step 1 by 1 to 3 cm and soaking for 30 to 50 minutes, then boiling over high heat, then decocting over low heat for 50 to 70 minutes, and filtering through a Chinese medicine sieve to obtain a first filtrate; then adding water to cover the drug residue, boiling over high heat, then decocting over low heat for 50 to 70 minutes, and filtering through a Chinese medicine sieve to remove the drug residue to obtain a second filtrate; combining the first filtrate and the second filtrate;

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

[0066] The present invention also provides a method for preparing the above-mentioned drug for treating vascular dementia, wherein the drug is a pill, and the preparation method thereof is as follows:

[0067] Step 1: weigh the raw materials except tortoise shell glue and deer antler glue according to the weight ratio, select, dry, cut, crush, sieve, and mix evenly;

[0068] Step 2: adding water to cover the raw material drug obtained in step 1 by 1 to 3 cm and soaking it for 30 to 50 minutes, then boiling it with high heat, then decocting it with low heat for 50 to 70 minutes, and filtering it with a Chinese medicine sieve to obtain a first filtrate; then adding water to cover the slag, boiling it with high heat, then decocting it with low heat for 50 to 70 minutes, and filtering the slag with a Chinese medicine sieve to obtain a second filtrate; combining the first filtrate and the second filtrate, placing it in a vacuum dryer, and drying it at a temperature of 40 to 60° C. and a pressure of 5 to 6 kPa until the weight no longer decreases;

[0069] Step three, heat the honey to 100-120°C, then mix it evenly with the dry medicine and honey in step two in a mass ratio of 1:1.2, then add tortoise shell glue and deer antler glue and mix evenly, simmer on low heat at 100-120°C for 15-25 minutes, then naturally cool to room temperature and add it to a pill making machine to obtain pills.

[0070] The present invention also provides a method for preparing the above-mentioned drug for treating vascular dementia, wherein the drug is an ointment, and the preparation method thereof is as follows:

[0071] Step 1: weigh the raw materials except tortoise shell glue and deer antler glue according to the weight ratio, select, dry, cut, crush, sieve, and mix evenly;

[0072] Step 2: adding water to cover the raw material drug obtained in step 1 by 1 to 3 cm and soaking it for 30 to 50 minutes, then boiling it with high heat, then decocting it with low heat for 50 to 70 minutes, and filtering it with a Chinese medicine sieve to obtain a first filtrate; then adding water to cover the slag, boiling it with high heat, then decocting it with low heat for 50 to 70 minutes, and filtering the slag with a Chinese medicine sieve to obtain a second filtrate; combining the first filtrate and the second filtrate, placing it in a vacuum dryer, and drying it at a temperature of 40 to 60° C. and a pressure of 5 to 6 kPa until the weight no longer decreases;

[0073] Step three, heat the honey to 100-120°C, then mix it evenly with the dry medicine in step two, honey and water in a mass ratio of 1:1.2:2, then add tortoise shell glue and deer antler glue and mix evenly, simmer over low heat at 100-120°C and stir continuously, and when the medicine is cooked, pour the ointment into a dry container to obtain the ointment.

[0074] The present invention is further described in detail below in conjunction with specific embodiments:

[0075] Example 1

[0076] A Chinese medicine composition for treating vascular dementia, comprising the following Chinese medicine ingredients in parts by mass: 10 parts of Rehmannia root, 10 parts of Chinese yam, 8 parts of cornus officinalis, 8 parts of oriental rhizome, 8 parts of Poria cocos, 8 parts of moutan bark, 8 parts of cinnamon twig, 5 parts of aconite root, 8 parts of calamus, 8 parts of processed polygala root, 8 parts of vinegared turmeric, 1 part of tortoise shell glue, 1 part of antler glue, 10 parts of Achyranthes bidentata, 10 parts of salt dodder seed, 5 parts of gastrodia elata, 10 parts of mistletoe, and 10 parts of salt eucommia. The drug for treating vascular dementia in Example 1 is a granule, and its preparation method is as follows:

[0077] Step 1: weigh the raw materials except tortoise shell glue and deer antler glue according to the weight ratio, select, dry, cut, crush, sieve, and mix evenly;

[0078] Step 2: Add water to cover the raw material drug obtained in step 1 by 3 cm and soak for 50 minutes, then boil over high heat, then continue to decoct for 60 minutes over low heat, and filter through a Chinese medicine sieve to obtain a first filtrate; then add water to cover the slag, boil over high heat, then continue to decoct for 60 minutes over low heat, and filter through a Chinese medicine sieve to remove the slag to obtain a second filtrate, and combine the first filtrate and the second filtrate;

[0079] Step 3: Add tortoise shell glue and deer antler glue to the combined filtrate in step 2, mix well, place in a vacuum dryer, and dry at a temperature of 50° C. and a pressure of 6 kPa until the weight no longer decreases to obtain granules.

[0080] Example 2

[0081] A Chinese medicine composition for treating vascular dementia, comprising the following Chinese medicine ingredients in parts by mass: 12 parts of Rehmannia root, 12 parts of Chinese yam, 10 parts of cornus officinalis, 10 parts of oriental rhizome, 10 parts of Poria cocos, 10 parts of moutan bark, 10 parts of cinnamon twig, 7 parts of aconite root, 10 parts of calamus, 10 parts of processed polygala root, 10 parts of vinegar-curcuma, 2 parts of tortoise shell glue, 2 parts of antler glue, 12 parts of Achyranthes bidentata, 12 parts of salt dodder seed, 7 parts of gastrodia elata, 12 parts of mistletoe, and 12 parts of salt eucommia bark. The drug for treating vascular dementia in Example 2 is a pill, and its preparation method is as follows:

[0082] Step 1: weigh the raw materials except tortoise shell glue and deer antler glue according to the weight ratio, select, dry, cut, crush, sieve, and mix evenly;

[0083] Step 2: adding water to cover the raw material drug obtained in step 1 by 3 cm and soaking for 40 minutes, then boiling with high heat, then decocting with low heat for 60 minutes, filtering with a Chinese medicine sieve to obtain a first filtrate; then adding water to cover the slag, boiling with high heat, then decocting with low heat for 60 minutes, filtering with a Chinese medicine sieve to remove the slag, obtaining a second filtrate; combining the first filtrate and the second filtrate, placing in a vacuum dryer, and drying at a temperature of 60° C. and a pressure of 6 kPa until the weight no longer decreases;

[0084] Step three, heat the honey to 110°C, then mix it evenly with the dry medicine and honey in step two in a mass ratio of 1:1.2, then add tortoise shell glue and deer antler glue and mix evenly, simmer on low heat at 110°C for 20 minutes, then naturally cool to room temperature and add it to a pill making machine to obtain pills.

[0085] Example 3

[0086] A Chinese medicine composition for treating vascular dementia, comprising the following Chinese medicine ingredients in parts by mass: 14 parts of Rehmannia root, 14 parts of Chinese yam, 11 parts of cornus officinalis, 11 parts of oriental rhizome, 11 parts of Poria cocos, 11 parts of moutan bark, 11 parts of cinnamon twig, 8 parts of aconite root, 11 parts of calamus, 11 parts of processed polygala root, 11 parts of vinegared turmeric, 3 parts of tortoise shell glue, 3 parts of antler glue, 14 parts of Achyranthes bidentata, 14 parts of salt dodder seed, 9 parts of gastrodia elata, 14 parts of mistletoe, and 14 parts of salt eucommia. The drug for treating vascular dementia in Example 3 is a paste, and its preparation method is as follows:

[0087] Step 1: weigh the raw materials except tortoise shell glue and deer antler glue according to the weight ratio, select, dry, cut, crush, sieve, and mix evenly;

[0088] Step 2: adding water to cover the raw material drug obtained in step 1 by 2 cm and soaking it for 40 minutes, then boiling it with high heat, then decocting it with low heat for 50 minutes, and filtering it with a Chinese medicine sieve to obtain a first filtrate; then adding water to cover the slag, boiling it with high heat, then decocting it with low heat for 50 minutes, and filtering the slag with a Chinese medicine sieve to obtain a second filtrate; combining the first filtrate and the second filtrate, placing it in a vacuum dryer, and drying it at a temperature of 40° C. and a pressure of 5 kPa until the weight no longer decreases;

[0089] Step three, heat the honey to 120°C, then mix it evenly with the dry medicine in step two, honey and water in a mass ratio of 1:1.2:2, then add tortoise shell glue and deer antler glue and mix evenly, simmer over low heat at 100°C and stir constantly, and when the medicine is cooked, pour the ointment into a dry container to obtain the ointment.

[0090] Example 4

[0091] A Chinese medicine composition for treating vascular dementia, comprising the following Chinese medicine ingredients in parts by weight: 15 parts of Rehmannia root, 15 parts of Chinese yam, 12 parts of cornus officinalis, 12 parts of oriental radix, 12 parts of Poria cocos, 12 parts of moutan bark, 12 parts of cinnamon twig, 9 parts of aconite root, 12 parts of calamus, 12 parts of processed polygala root, 12 parts of vinegar-curcuma, 3 parts of tortoise shell glue, 3 parts of antler glue, 15 parts of Achyranthes bidentata, 15 parts of salt dodder seed, 10 parts of gastrodia elata, 15 parts of mistletoe, and 15 parts of salt eucommia. The drug for treating vascular dementia in Example 4 is a granule, and its preparation method is the same as that in Example 1.

[0092] Example 5

[0093] A Chinese medicine composition for treating vascular dementia, comprising the following Chinese medicine ingredients in parts by weight: 16 parts of Rehmannia root, 16 parts of Chinese yam, 13 parts of cornus officinalis, 13 parts of oriental rhizome, 13 parts of Poria cocos, 13 parts of moutan bark, 13 parts of cinnamon twig, 10 parts of aconite root, 13 parts of calamus, 13 parts of processed polygala root, 13 parts of vinegar-curcuma, 4 parts of tortoise shell glue, 4 parts of antler glue, 16 parts of Achyranthes bidentata, 16 parts of salt dodder seed, 11 parts of gastrodia elata, 16 parts of mistletoe, and 16 parts of salt eucommia. The drug for treating vascular dementia in Example 5 is a pill, and its preparation method is the same as that in Example 2.

[0094] Example 6

[0095] A Chinese medicine composition for treating vascular dementia, comprising the following Chinese medicine ingredients in parts by weight: 18 parts of Rehmannia root, 18 parts of Chinese yam, 14 parts of cornus officinalis, 14 parts of oriental rhizome, 14 parts of Poria cocos, 14 parts of Paeonia suffruticosa, 14 parts of cinnamon twig, 11 parts of Radix Aconiti Lateralis Preparata, 14 parts of Acorus calamus, 14 parts of processed Polygala tenuifolia, 14 parts of vinegar-curcuma aromatica, 5 parts of tortoise shell glue, 5 parts of antler glue, 18 parts of Achyranthes bidentata, 18 parts of salt dodder seeds, 13 parts of Gastrodia elata, 18 parts of Morus parasiticus, and 18 parts of salt Eucommia ulmoides. The drug for treating vascular dementia in Example 6 is a paste, and its preparation method is the same as that in Example 3.

[0096] Example 7

[0097] A Chinese medicine composition for treating vascular dementia, comprising the following Chinese medicine ingredients in parts by weight: 20 parts of Rehmannia root, 20 parts of Chinese yam, 16 parts of cornus officinalis, 16 parts of oriental rhizome, 16 parts of Poria cocos, 16 parts of moutan bark, 16 parts of cinnamon twig, 13 parts of aconite root, 16 parts of calamus, 16 parts of processed polygala root, 16 parts of vinegar-curcuma, 6 parts of tortoise shell glue, 6 parts of antler glue, 20 parts of Achyranthes bidentata, 20 parts of salt dodder seed, 15 parts of gastrodia elata, 20 parts of mistletoe, and 20 parts of salt eucommia. The drug for treating vascular dementia in Example 7 is a granule, and its preparation method is the same as that in Example 1.

[0098] In order to verify the efficacy of the drug, the drug prepared in the preferred embodiment 4 was used to conduct experiments to identify the efficacy of the drug on patients with vascular dementia:

[0099] 1. Source of cases

[0100] The cases included in this study were all patients who visited the outpatient department of encephalopathy of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine from August 2022 to September 2024. A total of 200 patients who met the diagnostic criteria and inclusion criteria for vascular dementia with kidney essence deficiency syndrome were collected.

[0101] 2. Diagnostic criteria

[0102] 2.1 Western medicine diagnostic criteria

[0103] This guideline was developed based on the 2019 Guidelines for the Diagnosis and Treatment of Vascular Cognitive Impairment in China issued by the Cognitive Impairment Committee of the Neurology Branch of the Chinese Medical Association in 2019 and the 2014 VASCOG Consensus: Diagnostic Criteria for Vascular Cognitive Impairment issued by the International Society for Vascular Behavior and Cognitive Disorders in 2014.

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

[0105] (2) Cerebrovascular disease: Neurological examination shows focal signs consistent with stroke (regardless of whether 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 temporally associated with one or more cerebrovascular events;

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

[0109] (6) Not better explained by other encephalopathy or other systemic diseases.

[0110] 2.2 Traditional Chinese Medicine Diagnostic Criteria

[0111] Vascular dementia is not a disease term in Traditional Chinese Medicine literature. Based on its characteristics and clinical manifestations, it is classified within the TCM categories of "forgetfulness," "dementia," and "dementia." This study developed diagnostic criteria for the kidney-essence deficiency type of this disease based on the "Clinical Guidelines for the Treatment of Senile Dementia with New Chinese Medicines" in the 2002 "Guiding Principles for Clinical Research of New Chinese Medicines," Tian Jinzhou's "Diagnosis, Syndrome Differentiation, and Efficacy Criteria for Vascular Dementia," and the "New Century (Second Edition) National Higher Education TCM Colleges and Universities Planning Textbook: Traditional Chinese Medicine Internal Medicine."

[0112] Main symptoms: intellectual impairment, behavioral disorders, slow reaction, chills and cold limbs, soreness of waist and knees, clear and cold urine or difficulty urinating, edema of limbs, mental depression, fatigue and weakness;

[0113] Secondary symptoms: cough with a lot of sputum, chest tightness, abdominal distension, dark purple complexion or lips;

[0114] Tongue and pulse: The tongue is dark purple, the tongue is fat, the edges have teeth marks, the tongue coating is smooth or thick, and the pulse is

[0115] The pulse is slow, weak, or thin, astringent, or slippery.

[0116] The diagnosis can be confirmed if at least two of the main symptoms are present, and at least one of the following two symptoms, intellectual impairment, behavioral disorders, and slow reaction, is present, combined with the tongue and pulse.

[0117] 3. Inclusion and exclusion criteria

[0118] 3.1 Inclusion criteria

[0119] (1) Aged 50 ≤ ≤ 80 years, both men and women, conscious and able to communicate;

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

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

[0122] (4) CDR score is mild or moderate dementia;

[0123] (5) 10 points ≤ MMSE score ≤ 26 points, including illiterate ≤ 17 points, primary school ≤ 20 points, secondary school ≤ 22 points, and university ≤ 23 points;

[0124] (6) MoCA score <26 points;

[0125] (7) Volunteer to participate in this trial 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 severe primary diseases of other systems;

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

[0130] (4) Patients who have recently used drugs that may affect cognitive function;

[0131] (5) patients who were also participating in other studies;

[0132] (6) Patients with allergic constitution.

[0133] 3.3 Interruption criteria

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

[0135] (2) Patients who experience severe adverse reactions after taking the drug or other serious complications during the trial;

[0136] (3) Patients with poor compliance, inability to adhere to medication, self-changing medications, or self-adding or subtracting medications;

[0137] (4) Patients who cannot continue taking medication due to personal reasons and voluntarily request to withdraw from this study.

[0138] 3.4 Shedding standards and treatment

[0139] (1) Dropout criteria: Patients who signed the informed consent, met the inclusion and exclusion criteria, and failed to complete the prescribed trial cycle were considered dropout cases.

[0140] (2) Treatment of dropout cases

[0141] ① Contact the patient promptly by phone, online communication, door-to-door visits, etc., obtain as much relevant information as possible from the patient, understand the cause in detail and keep 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 patients who have dropped out should be objectively recorded and properly preserved.

[0144] 3.5 Rejection criteria

[0145] After the case observation is completed and before the statistical analysis of the data is performed, the principal researcher should decide whether to exclude the case.

[0146] (1) Cases that did not meet the inclusion criteria and were mistakenly included;

[0147] (2) patients with incomplete clinical data or deceased;

[0148] (3) Those who refuse to cooperate without reason and withdraw from the research.

[0149] 4. Observation indicators

[0150] Activities of daily living (ADL) and Clinical Dementia Rating (CDR) examinations were performed.

[0151] 5. Data Analysis

[0152] Statistical analysis was performed using SPSS 26.0. Measurement data were expressed as mean ± standard deviation. Homogeneity of variance was tested for each group. Under normal distribution conditions, one-way analysis of variance was used to compare means between experimental groups. The t-test or paired t-test was used to compare groups. P < 0.05 was considered statistically significant.

[0153] 6. Research Plan

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

[0155] (1) Control group: The patients were treated with conventional Jinkuishenqi Pills (Beijing Tongrentang), taking 20 pills of Jinkuishenqi Pills twice a day, morning and evening, for 8 weeks.

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

[0157] 7. Research Results

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

[0159] Grouping Number of cases Before treatment After treatment Difference Z P Treatment group 25 25.52(18.00,31.00) <![CDATA[19.84(15.00,24.50) * ]]> <![CDATA[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 the comparison between the treatment group before and after treatment; the difference between the treatment group and the control group after 8 weeks of treatment, △ P<0.05.

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

[0162] Grouping 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)* <![CDATA[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 the comparison between the treatment group before and after treatment; the difference between the treatment group and the control group after 8 weeks of treatment, △ P<0.05.

[0164] As can be seen from the table above, there was no statistically significant difference in the ADL and CDR scores between the treatment group and the control group before treatment (P>0.05), indicating that the two groups of patients were comparable. After 8 weeks of treatment, both the treatment group and the control group had significantly improved ADL scores (P<0.05), but the control group had no significant change in CDR scores. This indicates that the Chinese medicine composition for treating vascular dementia of the present invention significantly improves the intellectual status and living ability of patients with vascular dementia. While Jinkuishenqi Pills are effective in improving living ability, they do not significantly improve memory. The ADL and CDR scores of the treatment group were significantly higher than those of the control group (P<0.05). The comparison of the before and after differences indicates that the Chinese medicine composition for treating vascular dementia of the present invention can better improve the intellectual level of patients with vascular dementia than Jinkuishenqi Pills, has a clear therapeutic effect for treating vascular dementia, and can be used to prepare a drug for treating vascular dementia.

[0165] Typical cases:

[0166] Case 1: Jing Moumou, male, 74 years old, first diagnosed on August 11, 2022. Chief complaint: progressive intellectual decline for one month. Family members said that the patient had suffered cerebral infarction twice in recent years. One month ago, his intelligence declined, his facial expression was dull, he could not calculate, he could not call out the names of his family members, he could walk independently, drag the floor when walking, he had incontinence when urinating and defecating, coughed when drinking water, his speech was unclear, his tongue was pale, his fur was yellow and greasy, and his pulse was deep and smooth. Western medicine diagnosis: vascular dementia, Chinese medicine diagnosis: stroke dementia, the card belongs to the syndrome of kidney essence deficiency, and it is treated with warming and tonifying kidney yang, awakening the brain and opening the orifices. The granules prepared by Example 4 provided by the present invention are taken orally, 1 dose per day, divided into 2 doses. After the patient took the medicine for 1 week, his condition was significantly alleviated, his facial expression was rich, his reaction was more sensitive than before, his questions and answers were relevant, he could say the names of his family members, his calculation ability was improved, mopping the floor when walking was significantly alleviated, incontinence and coughing when drinking water were significantly reduced, his speech was clear, his tongue was dark red, his fur was thick yellow, and his pulse was deep and smooth.

[0167] Case 2: Mr. Li, male, 52 years old, first visited the hospital on January 7, 2023. Chief complaint: memory loss for more than one month. The patient had a history of hypertension for many years and suffered a cerebral infarction one month ago. After that, he developed memory loss, got lost when going out, had slow reaction, and had increased nocturia, 2 to 3 times a night. His appetite and sleep were normal. His tongue was pale, with a thick and greasy white fur, and a stringy and slippery pulse. Western medicine diagnosis: vascular dementia. Traditional Chinese medicine diagnosis: stroke dementia, kidney essence deficiency syndrome. Treatment principle: nourish the liver and kidney, resolve phlegm and blood stasis, and open up the brain. Orally take the granules prepared in Example 4 provided by the present invention, 1 dose per day, divided into 2 doses. After two weeks of medication, his memory improved significantly, he did not get lost again, his reaction was more sensitive than before, his nocturia decreased, 1 to 2 times a night, his appetite and sleep were normal, his tongue was pale, with a thick and greasy yellow fur, and a stringy and slippery pulse.

[0168] The foregoing description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention are intended to be within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating vascular dementia, characterized in that: Including the following raw medicinal materials: Rehmannia root, yam, wine-cooked cornus, Alisma orientalis, Poria, peony bark, cinnamon twig, aconite root, Acorus calamus, processed Polygala tenuifolia, vinegar-curcuma, tortoise shell glue, antler glue, Achyranthes bidentata, salt dodder seed, Gastrodia elata, Viscum album and salt Eucommia ulmoides.

2. The Chinese medicine composition for treating vascular dementia according to claim 1, characterized in that: The raw medicinal materials are included by mass: 10-20 parts of Rehmannia root, 10-20 parts of Dioscorea opposita, 8-16 parts of Cornus officinalis, 8-16 parts of Alisma orientalis, 8-16 parts of Poria cocos, 8-16 parts of Paeonia suffruticosa, 8-16 parts of Cassia twig, 5-13 parts of Aconite root, 8-16 parts of Acorus calamus, 8-16 parts of processed Polygala tenuifolia, 8-16 parts of Curcuma aromatica with vinegar, 1-6 parts of tortoise shell glue, 1-6 parts of antler glue, 10-20 parts of Achyranthes bidentata, 10-20 parts of salt Cuscuta seed, 5-15 parts of Gastrodia elata, 10-20 parts of Viscum album, and 10-20 parts of salt Eucommia ulmoides.

3. The Chinese medicine composition for treating vascular dementia according to claim 1, characterized in that: The raw medicinal materials are included by mass: 12-18 parts of Rehmannia root, 12-18 parts of Dioscorea opposita, 10-14 parts of Cornus officinalis, 10-14 parts of Alisma orientalis, 10-14 parts of Poria cocos, 10-14 parts of Paeonia suffruticosa, 10-14 parts of Cassia twig, 7-11 parts of Aconite root, 10-14 parts of Acorus calamus, 10-14 parts of processed Polygala tenuifolia, 10-14 parts of Curcuma aromatica with vinegar, 2-5 parts of tortoise shell glue, 2-5 parts of antler glue, 12-18 parts of Achyranthes bidentata, 12-18 parts of salt Cuscuta chinensis, 7-13 parts of Gastrodia elata, 12-18 parts of Viscum album, and 12-18 parts of salt Eucommia ulmoides.

4. The Chinese medicine composition for treating vascular dementia according to claim 1, characterized in that: The raw medicinal materials are included by mass: 14-16 parts of Rehmannia root, 14-16 parts of Dioscorea opposita, 11-13 parts of Cornus officinalis, 11-13 parts of Alisma orientalis, 11-13 parts of Poria cocos, 11-13 parts of Paeonia suffruticosa, 11-13 parts of Cassia twig, 8-10 parts of Aconite root, 11-13 parts of Acorus calamus, 11-13 parts of processed Polygala tenuifolia, 11-13 parts of Curcuma aromatica with vinegar, 3-4 parts of tortoise shell glue, 3-4 parts of antler glue, 14-16 parts of Achyranthes bidentata, 14-16 parts of salt Cuscuta seed, 9-11 parts of Gastrodia elata, 14-16 parts of Viscum album, and 14-16 parts of salt Eucommia ulmoides.

5. Use of the Chinese medicinal composition for treating vascular dementia according to any one of claims 1 to 4 in the preparation of a medicament for treating vascular dementia.

6. A drug for treating vascular dementia, characterized in that: The invention comprises the Chinese medicine composition for treating vascular dementia as claimed in any one of claims 1 to 4 and pharmaceutically acceptable excipients.

7. The drug for treating vascular dementia according to claim 6, characterized in that: The dosage form of the medicine is Chinese medicine decoction, decoction, granules, pills, capsules, tablets, tea, suspension, powder or oral solution.

8. The method for preparing the drug for treating vascular dementia according to claim 7, characterized in that: The medicine is a granule, and its preparation method is as follows: Step 1, weighing the raw materials except tortoise shell glue and deer antler glue according to the weight ratio, cleaning, drying, cutting, crushing, sieving, and mixing evenly; Step 2: adding water to cover the raw material medicine obtained in step 1 by 1 to 3 cm and soaking for 30 to 50 minutes, then boiling with high heat, then changing to low heat and continuing to decoct for 50 to 70 minutes, filtering with a Chinese medicine sieve to obtain a first filtrate; then adding water to the drug residue to cover the drug residue, boiling with high heat, changing to low heat and continuing to decoct for 50 to 70 minutes, filtering out the drug residue with a Chinese medicine sieve to obtain a second filtrate; combining the first filtrate and the second filtrate; Step three, add tortoise shell glue and deer antler glue to the combined filtrate in step two, mix evenly, place in a vacuum dryer, and dry at a temperature of 40-60° C. and a pressure of 5-6 KPa until the weight no longer decreases, to obtain granules.

9. The method for preparing the drug for treating vascular dementia according to claim 7, characterized in that: The medicine is a pill, and its preparation method is as follows: Step 1, weighing the raw materials except tortoise shell glue and deer antler glue according to the weight ratio, cleaning, drying, cutting, crushing, sieving, and mixing evenly; Step 2, adding water to cover the raw material medicine obtained in step 1 by 1 to 3 cm and soaking for 30 to 50 minutes, then boiling with high heat, then changing to low heat and continuing to decoct for 50 to 70 minutes, filtering with a Chinese medicine sieve to obtain a first filtrate; then adding water to the drug residue to cover the drug residue, boiling with high heat, changing to low heat and continuing to decoct for 50 to 70 minutes, filtering out the drug residue with a Chinese medicine sieve to obtain a second filtrate; combining the first filtrate and the second filtrate, placing in a vacuum dryer, and drying at a temperature of 40 to 60° C. and a pressure of 5 to 6 KPa until the weight no longer decreases; Step three, heating the honey to 100-120° C., then mixing it with the dry medicine and honey in step two in a mass ratio of 1:1.2, then adding tortoise shell glue and deer antler glue and mixing them evenly, simmering on low heat at 100-120° C. for 15-25 minutes, then naturally cooling to room temperature before adding it to a pill-making machine to obtain pills.

10. The method for preparing the drug for treating vascular dementia according to claim 7, characterized in that: The medicine is an ointment, and its preparation method is as follows: Step 1, weighing the raw materials except tortoise shell glue and deer antler glue according to the weight ratio, cleaning, drying, cutting, crushing, sieving, and mixing evenly; Step 2, adding water to cover the raw material medicine obtained in step 1 by 1 to 3 cm and soaking for 30 to 50 minutes, then boiling with high heat, then changing to low heat and continuing to decoct for 50 to 70 minutes, filtering with a Chinese medicine sieve to obtain a first filtrate; then adding water to the drug residue to cover the drug residue, boiling with high heat, changing to low heat and continuing to decoct for 50 to 70 minutes, filtering out the drug residue with a Chinese medicine sieve to obtain a second filtrate; combining the first filtrate and the second filtrate, placing in a vacuum dryer, and drying at a temperature of 40 to 60° C. and a pressure of 5 to 6 KPa until the weight no longer decreases; Step three, heat the honey to 100-120°C, then mix it evenly with the dry medicine in step two, honey and water in a mass ratio of 1:1.2:2, then add tortoise shell glue and deer antler glue and mix evenly, simmer over low heat at 100-120°C and stir constantly, and when the medicine is cooked, pour the ointment into a dry container to obtain an ointment.