Traditional Chinese medicine compound composition for treating dementia caused by marrow sea deficiency and preparation method of traditional Chinese medicine compound composition

Abstract

The invention discloses a traditional Chinese medicine compound composition for treating marrow sea deficiency type dementia and a preparation method thereof, and the traditional Chinese medicine compound composition comprises the following raw materials in parts by weight: 16-22 parts of lucid ganoderma, 19-24 parts of fructus rosae laevigatae, 18-23 parts of longan aril, 17-24 parts of rhizoma dioscoreae and 19-25 parts of radix fici simplicissimae. The preparation method of the traditional Chinese medicine compound composition comprises the following steps: a, weighing the lucid ganoderma, the fructus rosae laevigatae, the longan aril, the rhizoma dioscoreae and the radix fici simplicissimae according to the weight ratio; and b, putting the raw materials weighed in the step a into water, and decocting the raw materials to prepare liquid medicine to prepare the traditional Chinese medicine compound composition for treating dementia. The traditional Chinese medicine compound composition has remarkable advantages. The traditional Chinese medicine composition is mild in medicine property, is mostly a medicine-food homologous product, can nourish the body in multiple dimensions, is higher in safety after being used for a long time, and conforms to the traditional Chinese medicine'preventive treatment 'and overall conditioning concept; the used medicinal materials are common and easy to find, are low in cost and convenient to widely popularize and apply clinically, and have great practical value.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine for treating dementia, and particularly relates to a traditional Chinese medicine compound composition for treating dementia of the type of insufficient marrow sea. Technical Background

[0002] Dementia is a chronic and progressive neurodegenerative disease that affects the functions of the brain, leading to a continuous decline in various cognitive abilities. Dementia is not just about memory loss; it also involves impairments in other cognitive domains, such as language, visuospatial ability, judgment, thinking, and behavior. Dementia can affect an individual's daily life and work capabilities, and in severe cases, it can even affect basic self-care abilities. With the aging of the population, dementia has become a common disease among the elderly, and Alzheimer's disease (AD) dementia accounts for 60%-80%, which is the main cause of disability and death in the elderly. The prevention and treatment of AD is a worldwide problem, mainly because it is difficult to diagnose in the early stage. Existing drug treatments mainly focus on symptom relief rather than radical cure of the disease, and the curative effects are limited. At the same time, there is no effective treatment drug clinically to prevent the occurrence of AD or reverse its progression. The first principle of AD treatment is "diagnose as early as possible, treat in a timely manner, and manage for life". In-depth research on dementia, exploring its pathogenesis, risk factors, prevention strategies, and effective treatment methods is of great significance for improving the prognosis of patients, reducing the burden on families and society, and promoting healthy aging. Traditional Chinese medicine and its compound preparations have the characteristics of multi-channel and multi-target effects.

[0003] Chinese Patent CN103656484B discloses a traditional Chinese medicine composition for treating dementia and its preparation method. The characteristics are that the composition is composed of traditional Chinese medicine raw materials with the following weight ratios: extracts of Corydalis decumbens; extracts of Curcuma longa; extracts of Eugenia caryophyllata. The traditional Chinese medicine composition obtained by the present invention can reduce the brain tissue damage caused by cerebral ischemia and effectively prevent and treat senile dementia, vascular dementia, and vascular sequelae.

[0004] Chinese Patent Application Document CN107929666A discloses a traditional Chinese medicine composition for treating dementia and its preparation method. Among them, the traditional Chinese medicine composition is composed of traditional Chinese medicine raw materials with the following weight parts ratios: Rehmannia glutinosa, Lycium barbarum, Morinda officinalis, Cassia obtusifolia, Alisma orientale, Acorus tatarinowii, Polygala tenuifolia, Salvia miltiorrhiza, Crataegus pinnatifida, Ligusticum chuanxiong, Alpinia oxyphylla, Cornus officinalis, Curcuma aromatica, Pseudostellaria heterophylla, Ziziphus jujuba var. spinosa, Arisaema heterophyllum, and Glycyrrhiza uralensis. The traditional Chinese medicine composition for treating dementia of the present invention can treat dementia fundamentally, especially senile dementia.

[0005] The drug formulations in the above two patents both incorporate multiple drug ingredients and are not comprehensive enough in terms of comprehensive conditioning and safety. The first patent mainly uses Corydalis Decumbentis, Turmeric, and Cloves. With fewer types of drugs, although it has the effect of promoting blood circulation and qi movement, it lacks the synergistic tonifying effect on multiple zang-fu organs and is difficult to meet the overall conditioning needs of the body. The second patent covers multiple types of medicinal materials such as tonifying, promoting blood circulation, and resolving phlegm, but the ingredients are complex. The combination of cold and hot drugs (such as the warm Morinda Officinalis and the cool Cassia Tora) increases the risk of incompatibility; the use of drastic medicinal materials such as Arisaema Cum Bile also increases the probability of adverse reactions.

[0006] Therefore, the object of the present invention is to address the deficiencies in the prior art. By conducting traditional Chinese medicine syndrome differentiation and treatment for dementia patients, a traditional Chinese medicine compound composition for treating dementia is provided, giving play to the advantages of traditional Chinese medicine and providing more treatment options for clinical practice. Summary of the Invention

[0007] The present invention provides a traditional Chinese medicine compound composition for treating dementia and its preparation method to address the current lack of simple and effective traditional Chinese medicine treatments for dementia. This traditional Chinese medicine compound composition is characterized by being economical, having significant efficacy, mild medicinal properties, high safety, and being suitable for long-term conditioning.

[0008] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0009] A traditional Chinese medicine compound composition for treating dementia of the type of insufficient marrow sea includes the following raw materials in parts by weight: 16 - 22 parts of Ganoderma Lucidum, 19 - 24 parts of Rosa Laevigata Michx., 18 - 23 parts of Longan Aril, 17 - 24 parts of Rhizoma Dioscoreae Oppositae, and 19 - 25 parts of Ficus Hirta Vahl.

[0010] Preferably, the traditional Chinese medicine compound composition for treating dementia of the type of insufficient marrow sea includes the following raw materials in parts by weight: 20 parts of Ganoderma Lucidum, 20 parts of Rosa Laevigata Michx., 20 parts of Longan Aril, 20 parts of Rhizoma Dioscoreae Oppositae, and 20 parts of Ficus Hirta Vahl.

[0011] Preferably, the traditional Chinese medicine compound composition for treating dementia of the type of insufficient marrow sea includes the following raw materials in parts by weight: 19 parts of Ganoderma Lucidum, 21 parts of Rosa Laevigata Michx., 22 parts of Longan Aril, 23 parts of Rhizoma Dioscoreae Oppositae, and 22 parts of Ficus Hirta Vahl.

[0012] Preferably, the traditional Chinese medicine compound composition for treating dementia of the type of insufficient marrow sea includes the following raw materials in parts by weight: 17 parts of Ganoderma Lucidum, 22 parts of Rosa Laevigata Michx., 21 parts of Longan Aril, 22 parts of Rhizoma Dioscoreae Oppositae, and 23 parts of Ficus Hirta Vahl.

[0013] Preferably, the traditional Chinese medicine compound composition for treating dementia of the type of insufficient marrow sea includes the following raw materials in parts by weight: 21 parts of Ganoderma Lucidum, 19 parts of Rosa Laevigata Michx., 19 parts of Longan Aril, 21 parts of Rhizoma Dioscoreae Oppositae, and 22 parts of Ficus Hirta Vahl.

[0014] Preferably, the traditional Chinese medicine compound composition for treating dementia of insufficient marrow sea is used by internal administration.

[0015] Preferably, the traditional Chinese medicine compound composition for treating dementia of insufficient marrow sea is taken by internal administration once after warming about half an hour after meals in the morning and evening every day.

[0016] Preferably, the dosage of the traditional Chinese medicine compound composition for treating dementia of insufficient marrow sea is 150 ml each time, and 4 weeks is taken as a complete treatment cycle.

[0017] The present invention also provides a preparation method of a traditional Chinese medicine compound composition for treating dementia of insufficient marrow sea, comprising the following steps:

[0018] a. Accurately weigh dry Ganoderma lucidum, Rosa laevigata Michx., longan pulp without pits, sliced Rhizoma Dioscoreae Oppositae, and cut Radix Morindae Officinalis according to the established weight ratio;

[0019] b. Put the weighed Chinese medicinal materials into an appropriate amount of water, extract the effective components by decocting, and finally prepare a traditional Chinese medicine compound liquid for treating dementia.

[0020] Preferably, the amount of water used in step b is specifically 500 ml.

[0021] Compared with the existing technical solutions, the traditional Chinese medicine compound composition involved in the present invention shows multi-dimensional technical superiority. The invention breaks through the traditional formula thinking, takes a unique path in the drug compatibility design, and at the same time deeply explores the characteristics and potential of each medicinal material, realizes synergistic effect through delicate medicinal material ratio, and realizes technical innovation from the aspects of medicinal material screening, formula design to action mechanism. Its specific advantages are reflected in the following aspects:

[0022] (1) Innovative formula design, multi-dimensional synergistic drug effect

[0023] The traditional Chinese medicine compound of the present invention carefully selects five highly characteristic Chinese medicinal materials, namely Ganoderma lucidum, Rosa laevigata Michx., longan aril, Rhizoma Dioscoreae Oppositae, and Ficus hirta Vahl, for scientific compatibility. Among them, Ganoderma lucidum can regulate vasoactive substances, stabilize blood pressure, and maintain the homeostasis of the cardiovascular system. Entering the heart meridian, it can soothe the heart and calm the mind, and improve restlessness of the mind such as dementia, palpitation, and anxiety. Rosa laevigata Michx. is good at astringing essence, reducing urination, and arresting leucorrhea, and can enhance the astringent function of the kidney and bladder, and has definite curative effects on spermatorrhea, spermatorrhea, enuresis, frequent urination, and excessive leucorrhea caused by deficiency of the kidney qi. Longan aril has the functions of tonifying the heart and spleen, nourishing blood and calming the mind. It is rich in nutrients, can greatly tonify the heart blood, enhance myocardial contractility, improve heart function, and relieve palpitation and anxiety. It can also nourish the spleen qi, promote the transportation and transformation of the spleen and stomach, increase appetite, and help as the source of qi and blood generation. When the heart blood is nourished, the mind will be at peace, and it can effectively improve mental symptoms caused by blood deficiency such as dementia, amnesia, dizziness, etc. Rhizoma Dioscoreae Oppositae is a good medicine for tonifying the three energizers evenly, with outstanding effects in strengthening the spleen and stomach. The amylase it contains can promote the digestion and absorption of food, enhance the transportation and transformation function of the spleen and stomach, and has definite curative effects on weakness of the spleen and stomach, poor appetite, and loose stools. It nourishes the lung and promotes fluid production, can nourish the lung yin, and relieve symptoms such as cough due to lung deficiency and shortness of breath. Entering the kidney meridian, it tonifies the kidney and benefits essence, can regulate the water metabolism and essence storage of the kidney, and improve symptoms such as soreness and weakness of the waist and knees, frequent urination, and tinnitus caused by kidney deficiency. Ficus hirta Vahl is sweet in taste and neutral in nature, and has the effects of strengthening the spleen and tonifying the lung, promoting qi circulation and removing dampness. It can enhance the transportation and transformation function of the spleen and stomach, and improve symptoms such as poor appetite, fatigue, abdominal distension, and loose stools caused by weakness of the spleen and stomach; it can tonify the lung qi and relieve discomfort such as cough due to lung deficiency and shortness of breath and fatigue; at the same time, by promoting qi circulation and removing dampness, it regulates water metabolism, and has a good conditioning effect on diseases caused by dampness obstruction such as heaviness of the limbs, edema, and rheumatic arthralgia pain. Moreover, its medicinal properties are mild, and the tonifying effect is not stagnant. It is the key medicine for strengthening the healthy qi and removing dampness in the formula.

[0024] (2) People-friendly economic formula, universal medication cost

[0025] The traditional Chinese medicine compound of the present invention demonstrates excellent advantages in innovation and practicality. In addition to the unique drug composition formula and remarkable therapeutic effects, it also has three core competitiveness: First, the cost is low. The selected medicinal materials are all common varieties with affordable prices, effectively controlling the production cost from the source and reducing the economic burden on patients; Second, it is convenient to use. Its preparation process is simplified, without complex operations, and is convenient for popularization and application; Third, it has high safety. Its medicinal properties are mild, and most of them are products of both medicine and food. Through delicate compatibility, the medicinal materials restrict each other, which can nourish the body in multiple dimensions, and can reduce the toxic and side effects while exerting the medicinal effects, meeting the concept of "preventive treatment of disease" in traditional Chinese medicine. It is a high-quality solution with both curative effects and cost performance. Detailed implementation manners

[0026] Next, in combination with the embodiments of the present invention, the technical solutions in the preferred examples will be clearly and completely described. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0027] In the embodiments of the present invention, a traditional Chinese medicine compound composition for treating dementia of the type of insufficient marrow sea includes the following raw materials in parts by weight: 16 - 22 parts of Ganoderma lucidum, 19 - 24 parts of Rosa laevigata Michx., 18 - 23 parts of longan aril, 17 - 24 parts of Rhizoma Dioscoreae, 19 - 25 parts of Ficus hirta Vahl. After weighing the above raw materials and putting them into 500 ml of clear water, after the raw materials are made into a medicinal liquid, 450 mL is taken and warm - taken about half an hour after meals twice a day, in the morning and evening.

[0028] The technical principle of the present invention:

[0029] I. The characteristics of each raw material medicinal herb used are as follows:

[0030] Ganoderma lucidum: It is a fungus of the genus Ganoderma in the family Polyporaceae. The medicinal part is the dried fruit body, sweet in taste and neutral in nature. It has the effects of replenishing qi and calming the mind, relieving cough and asthma, and can be used to treat symptoms such as dreaminess and restlessness in dementia, and cough and asthma due to lung deficiency. It is rich in components such as Ganoderma polysaccharides and triterpenoids, and has functions such as immune regulation and antioxidant, and is a precious Chinese medicinal herb that can be used both as medicine and food.

[0031] Rosa laevigata Michx.: It is an evergreen climbing shrub of the genus Rosa in the family Rosaceae. The medicinal part is the dried ripe fruit, sour, sweet, and astringent in taste, and neutral in nature. It can astringe essence and reduce urination, and astringe the intestine and stop diarrhea. It is mainly used to treat symptoms such as spermatorrhea, enuresis, frequent urination, chronic diarrhea due to spleen deficiency, chronic dysentery, and excessive leukorrhea, and has a significant effect in astringency and convergence.

[0032] Longan aril: It is the aril of the evergreen tree Dimocarpus longan Lour. of the genus Dimocarpus in the family Sapindaceae. The medicinal part is its dried pulp, sweet in taste and warm in nature. It can tonify the heart and spleen, nourish blood and calm the mind, and is mainly used to treat symptoms such as palpitation and forgetfulness caused by deficiency of both heart and spleen in dementia, and sallow complexion and fatigue caused by qi and blood deficiency, and has the effects of nourishment and calming the mind.

[0033] Rhizoma Dioscoreae: It is a perennial twining herbaceous vine of the genus Dioscorea in the family Dioscoreaceae. The medicinal part is the dried rhizome, sweet in taste and neutral in nature. It belongs to the spleen, lung, and kidney meridians, can invigorate the spleen and nourish the stomach, promote the production of body fluid and benefit the lung, and tonify the kidney and astringe essence. It is mainly used to treat symptoms such as poor appetite due to spleen deficiency, chronic diarrhea, cough and asthma due to lung deficiency, spermatorrhea due to kidney deficiency, excessive leukorrhea and frequent urination, and consumptive thirst with deficiency heat.

[0034] Prunus mume: It is a deciduous shrub or small tree of the genus Ficus in the Moraceae family. The medicinal part is the dried root, which is sweet and neutral in nature. It has the effects of strengthening the spleen and lungs, removing dampness and relaxing muscles. It is often used to treat spleen deficiency edema, loss of appetite, cough due to tuberculosis, rheumatic pain, edema and other symptoms. It is a commonly used Chinese medicinal material for both medicine and food in Lingnan area.

[0035] 2. Mechanism of synergistic interaction of the five raw materials in treating dementia

[0036] 1. Basic effects and synergy of Ganoderma lucidum

[0037] Lingzhi is sweet and mild in nature. It can replenish qi and calm the mind, relieve cough and asthma. In prescriptions, it can regulate the function of human organs and immune status. Patients with asthenia and cough are often accompanied by deficiency of vital energy, such as long-term illness that depletes lung and kidney qi. Lingzhi can strengthen the body and regulate qi, creating a suitable internal environment for other medicinal materials to synergistically exert their therapeutic effects, and enhancing the overall efficacy of the prescription in harmonizing qi and blood, replenishing deficiency and curing diseases.

[0038] Synergy with Rosa Laevigata: Lingzhi can replenish Qi and calm the mind, and can relieve dementia, dreaminess, palpitations, etc. caused by deficiency of both heart and spleen and insufficient Qi and blood. Although the main effect of Rosa Laevigata is not to calm the mind, it can help the body's Qi and blood to be retained by astringing and consolidating, which helps Lingzhi to better play its calming role and improve sleep quality.

[0039] Synergistic with longan pulp: Longan pulp can nourish the heart and spleen, nourish blood and calm the mind, and has a good effect on palpitations, dementia, forgetfulness, etc. caused by deficiency of both heart and spleen. Ganoderma lucidum can replenish qi and calm the mind, and synergistically with longan pulp, it can enhance the effect of nourishing the heart and spleen, and better improve various symptoms caused by deficiency of heart and spleen.

[0040] Synergistic effect with Chinese yam: Chinese yam is a commonly used Chinese medicine for strengthening the spleen and stomach, and can improve symptoms such as spleen and stomach weakness, poor appetite and fatigue. Ganoderma lucidum can replenish qi, and synergistically with Chinese yam, it can enhance the transportation and transformation function of the spleen and stomach, promote the digestion and absorption of food, and has a good conditioning effect on indigestion and loss of appetite caused by spleen and stomach qi deficiency.

[0041] Synergizes with five-fingered ginseng: Ganoderma lucidum replenishes qi and calms the mind, directly acts on the mind, regulates the circulation of qi and blood, and improves symptoms such as dementia and palpitations caused by deficiency of both heart and spleen and insufficient qi and blood; five-fingered ginseng strengthens the spleen and lungs, promotes qi and eliminates dampness, strengthens the spleen and stomach function from the root, promotes qi and blood biochemical transformation, and provides sufficient qi and blood foundation for Ganoderma lucidum to exert its calming effect. The two work together, five-fingered ginseng helps the formation of qi and blood by nourishing the acquired foundation, and Ganoderma lucidum directly nourishes the mind. One nourishes and the other replenishes, taking into account both the symptoms and the root causes, and jointly enhancing the effects of replenishing qi and blood, calming the mind and calming the mind, and more effectively improving symptoms such as restlessness caused by qi and blood deficiency.

[0042] 2. Key Role and Synergy of Rosa Laevigata

[0043] Rosa laevigata Michx. tastes sour, sweet, and astringent, and is of neutral nature. It can arrest seminal emission, reduce urination, and relieve diarrhea by astringing the intestine. In prescriptions, it can enhance the body's astringent ability. Patients with spermatorrhea and chronic diarrhea often have a deficiency of healthy qi, such as the failure of the kidney qi to secure due to kidney deficiency or spleen deficiency, and the abnormal transportation and transformation of the spleen and stomach. Rosa laevigata Michx. can astringe and consolidate, and tonify the lower energizer, providing a stable physical basis for other medicinal materials to play the role of tonifying deficiency and treating diseases, enabling the medicinal power to better act on the zang-fu organs and restoring the normal physiological functions of the human body.

[0044] Synergistic with longan pulp: Rosa laevigata Michx. is sour, astringent, and has the effects of arresting seminal emission, reducing urination, and stopping involuntary discharge. It can astringe the kidney qi and prevent the leakage of essence qi, and has a good therapeutic effect on spermatorrhea, spermatorrhea due to kidney deficiency. Longan pulp is sweet and warm, and is good at tonifying the heart and spleen, nourishing blood and calming the mind. It can make the heart blood sufficient and the mind nourished, and improve symptoms such as palpitation, dementia, and dreaminess. The two work synergistically. On the one hand, it can astringe essence to treat kidney deficiency, and on the other hand, it can nourish blood to treat deficiency of both the heart and spleen. For patients with symptoms such as spermatorrhea due to kidney deficiency and dementia due to deficiency of both heart and spleen blood, it can play a role in treating both the symptoms and the root cause.

[0045] Synergistic with Rhizoma Dioscoreae: Rosa laevigata Michx. can arrest seminal emission and reduce urination, astringe the kidney qi, and help the kidney qi to secure, which is conducive to the kidney water rising to nourish the heart. Longan pulp can tonify the heart and spleen, nourish blood and calm the mind, make the heart fire tranquil and the heart yin nourished, and is conducive to the heart fire descending to the kidney. The two work synergistically to communicate the heart and kidney, and have a certain conditioning effect on symptoms such as dementia, dreaminess, restlessness, and soreness and weakness of the waist and knees caused by the disharmony between the heart and kidney, and help restore the balance between the heart and kidney.

[0046] Synergistic with Ficus hirta Vahl: Rosa laevigata Michx. is a commonly used traditional Chinese medicine for arresting seminal emission and reducing urination, and has a good therapeutic effect on symptoms such as spermatorrhea, spermatorrhea, and frequent urination due to kidney deficiency. While strengthening the spleen, Ficus hirta Vahl also helps the acquired foundation to nourish the congenital foundation, thus indirectly playing a role in tonifying the kidney. When used synergistically with Rosa laevigata Michx., it can enhance the effect of tonifying the kidney and arresting seminal emission, start from both the spleen and kidney aspects, improve the related symptoms caused by kidney deficiency, and enhance the storing function of the kidney.

[0047] 3. Core functions and synergies of longan pulp

[0048] Longan pulp tastes sweet and is of warm nature, and belongs to the heart and spleen meridians. It has the effects of tonifying the heart and spleen, nourishing blood and calming the mind. It is one of the commonly used medicinal materials for regulating deficiency of both the heart and spleen, mainly targeting symptoms such as palpitation, dementia, forgetfulness, qi and blood deficiency, sallow complexion, and fatigue. It is especially suitable for situations such as the loss of nourishment of the mind and physical weakness caused by excessive thinking and overstrain of the heart and spleen.

[0049] Synergistic with Rhizoma Dioscoreae Oppositae: Rhizoma Dioscoreae Oppositae is a classic medicinal herb for invigorating the spleen and stomach, tonifying the kidney and arresting seminal emission. It has remarkable curative effects on symptoms such as anorexia, lassitude due to weakness of the spleen and stomach, loose stools and diarrhea, as well as soreness and weakness of the waist and knees, spermatorrhea and frequent urination caused by kidney deficiency. Longan aril is good at tonifying the heart and spleen, nourishing blood and tranquilizing the mind, and has outstanding curative effects on problems such as palpitation, insomnia and amnesia caused by deficiency of both the heart and spleen. When the two are used synergistically, Rhizoma Dioscoreae Oppositae consolidates the foundation of qi and blood generation and kidney essence nourishment from the perspectives of strengthening the spleen and stomach and tonifying the kidney, while Longan aril strengthens the generation of qi and blood and the tranquility of the mind by nourishing the heart and spleen, nourishing blood and tranquilizing the mind. The two complement each other, can improve the spleen and stomach transportation function from the root, and can nourish the zang-fu organs by tonifying qi and blood, jointly enhancing the qi and blood fullness and mental tranquility of the human body, and comprehensively improving a series of symptoms caused by deficiency of both the heart and spleen and insufficiency of qi and blood.

[0050] Synergistic with Ficus hirta Vahl: Ficus hirta Vahl is a commonly used medicinal herb for strengthening the spleen and tonifying the lung, promoting qi circulation and removing dampness. It has remarkable curative effects on symptoms such as anorexia due to spleen deficiency, cough due to lung deficiency, and heaviness and fatigue of the limbs. Longan aril is good at tonifying the heart and spleen, nourishing blood and tranquilizing the mind, and is commonly used to condition problems such as palpitation, insomnia and insufficiency of qi and blood caused by deficiency of both the heart and spleen. When Ficus hirta Vahl and Longan aril are used synergistically, Ficus hirta Vahl enhances the ability of the spleen and stomach to transform and transport, strengthens the generation of qi and blood by the acquired foundation, and provides sufficient nutrition for the whole body; Longan aril focuses on nourishing the heart and spleen, replenishing heart blood and tranquilizing the mind. The two complement each other, can strengthen qi and blood generation from the root of the spleen and stomach, and can promote the circulation of qi and blood and the tranquility of the mind by nourishing the heart and spleen. Starting from both qi and blood generation and mental nourishment and regulation, it can improve the related symptoms caused by deficiency of the heart and spleen and insufficiency of qi and blood, and enhance the overall qi and blood harmony and mental tranquility of the body.

[0051] 4. Important functions and synergy of Rhizoma Dioscoreae Oppositae

[0052] Synergistic with Poria cum Radix Pini: Poria cum Radix Pini tranquilizes the mind, and Semen Platycladi nourishes the heart and tranquilizes the mind. The two nourish the mind from different angles. Poria cum Radix Pini tranquilizes the mind by promoting diuresis and strengthening the spleen, while Semen Platycladi tranquilizes the mind by nourishing the heart blood. Their mutual cooperation enables the mind to be nourished comprehensively, and has a good synergistic therapeutic effect on dementia caused by reasons such as disharmony between the heart and kidney and insufficiency of heart blood.

[0053] 5. Integration of synergistic effects of Ficus hirta Vahl

[0054] Ficus hirta Vahl is sweet in taste, neutral in nature, and belongs to the spleen, lung and liver meridians, and has functions such as strengthening the spleen and tonifying the lung, promoting qi circulation and removing dampness, and relaxing muscles and activating collaterals. Its role in prescriptions is mainly to strengthen the spleen and stomach, tonify the lung qi and dredge the meridians.

[0055] Synergistic with other medicinal herbs: By strengthening the spleen and tonifying the lung, Ficus hirta Vahl can enhance the spleen and stomach transportation ability, promote the absorption of water and grain essence, provide sufficient raw materials for qi and blood generation, and at the same time regulate the qi mechanism of the human body and improve water metabolism. Good spleen and stomach function and smooth qi mechanism operation create favorable conditions for other medicinal herbs to play their roles.

[0056] 3. The importance of controlling the weight ratio of the five medicinal materials

[0057] Since the efficacy and potency of each herb are different, it is crucial to scientifically prepare the weight ratio of the five herbs. Strictly controlling the ratio within the range of (16-22):(19-24):(18-23):(17-24):(19-25) can not only give full play to the characteristics of each herb, but also enhance the overall efficacy of the prescription through synergy, ensuring the safety of medication and therapeutic effect.

[0058] Lingzhi nourishes Qi and calms the mind, while Rosa rugosa consolidates essence and reduces urine, and Longan pulp nourishes blood and calms the mind. If the proportion of Lingzhi is too high, it is easy to help fire generate heat, weakening the astringent and nourishing effects of Rosa rugosa and Longan pulp; if it is too low, it is difficult to replenish the positive Qi. If the proportion of Rosa rugosa is too high, it will be overly astringent and affect the circulation of Qi and blood; if it is too low, it will not be enough to consolidate. If the proportion of Longan pulp is unbalanced, it may cause greasy stomach irritation or lack of blood nourishment. The imbalance of the three will significantly reduce the overall conditioning effect of the prescription. Guangyam nourishes the spleen and kidneys, and Wuzhimao strengthens the spleen and promotes Qi. If the proportion of Guangyam is too high, the prescription is too nourishing and insufficient in promoting Qi, which is easy to stagnate the spleen and stomach and weaken the efficacy of Wuzhimao; if the proportion is too low, it is difficult to consolidate the positive Qi and affect the biochemical transformation of Qi and blood. If the proportion of Wuzhimao is too high, it will suppress the nourishing power of Guangyam, unbalance the dispersing effect; if the proportion is too low, it will not be enough to remove dampness and dredge the meridians. Both imbalances will reduce the comprehensive efficacy of the prescription for symptoms such as spleen deficiency and dampness, and limb fatigue.

[0059] In order to make the disclosure of the present invention more comprehensive, the present invention is further explained below in conjunction with specific implementation methods.

[0060] 1. Embodiment

[0061] Example 1

[0062] A Chinese medicinal compound composition for treating marrow sea deficiency type dementia comprises the following raw materials in parts by weight: 19 parts of ganoderma lucidum, 21 parts of rosa laevigata, 22 parts of longan pulp, 23 parts of yam, and 22 parts of quinquefolia.

[0063] Preparation method: After adding 500ml of clean water, after the raw materials are made into liquid medicine, take 450ml and take it warm twice a day, about half an hour after meals, in the morning and evening.

[0064] The method of use of the invention is: oral administration, twice a day, 150 ml each time, 4 weeks as a course of treatment.

[0065] Example 2

[0066] A Chinese medicinal compound composition for treating marrow sea deficiency type dementia comprises the following raw materials in parts by weight: 17 parts of ganoderma lucidum, 22 parts of rosa laevigata, 21 parts of longan pulp, 22 parts of yam, and 23 parts of quinquefolius.

[0067] Preparation method: After adding 500 ml of clear water and making the raw materials into a medicinal liquid, take 450 mL and warm it for oral administration about half an hour after meals twice a day, once in the morning and once in the evening.

[0068] The usage method of the present invention is: for oral administration, take it twice a day, 150 ml each time for oral administration, and 4 weeks is a treatment course.

[0069] Example 3

[0070] A traditional Chinese medicine compound composition for treating dementia, comprising the following raw materials in parts by weight: 20 parts of Ganoderma lucidum, 20 parts of Rosa laevigata Michx., 20 parts of longan pulp, 20 parts of Rhizoma Dioscoreae Oppositae, 20 parts of Ficus hirta Vahl.

[0071] Preparation method: After adding 500 ml of clear water and making the raw materials into a medicinal liquid, take 450 mL and warm it for oral administration about half an hour after meals twice a day, once in the morning and once in the evening.

[0072] The usage method of the present invention is: for oral administration, take it twice a day, 150 ml each time for oral administration, and 4 weeks is a treatment course.

[0073] Example 4

[0074] A traditional Chinese medicine compound composition for treating dementia, comprising the following raw materials in parts by weight: 21 parts of Ganoderma lucidum, 19 parts of Rosa laevigata Michx., 19 parts of longan pulp, 21 parts of Rhizoma Dioscoreae Oppositae, 22 parts of Ficus hirta Vahl.

[0075] Preparation method: After adding 500 ml of clear water and making the raw materials into a medicinal liquid, take 450 mL and warm it for oral administration about half an hour after meals twice a day, once in the morning and once in the evening.

[0076] The usage method of the present invention is: for oral administration, take it twice a day, 150 ml each time for oral administration, and 4 weeks is a treatment course.

[0077] Comparative Example 1

[0078] A traditional Chinese medicine compound composition for treating dementia, comprising the following raw materials in parts by weight: 11 parts of Ganoderma lucidum, 10 parts of Rosa laevigata Michx., 30 parts of longan pulp, 15 parts of Rhizoma Dioscoreae Oppositae, 12 parts of Ficus hirta Vahl.

[0079] Preparation method: After adding 500 ml of clear water and making the raw materials into a medicinal liquid, take 450 mL and warm it for oral administration about half an hour after meals twice a day, once in the morning and once in the evening.

[0080] The usage method of the present invention is: for oral administration, take it twice a day, 150 ml each time for oral administration, and 4 weeks is a treatment course.

[0081] Comparative Example 2

[0082] A traditional Chinese medicine compound composition for treating dementia, comprising the following raw materials in parts by weight: 12 parts of Ganoderma lucidum, 26 parts of Rosa laevigata Michx., 15 parts of longan pulp, 30 parts of Rhizoma Dioscoreae Oppositae, 13 parts of Ficus hirta Vahl.

[0083] Manufacturing method: After adding 500 ml of clear water, the raw materials are made into a medicinal liquid, and then 450 mL is taken and warm-administered about half an hour after meals twice a day, in the morning and evening.

[0084] The usage method of the present invention is: for oral administration, taken twice a day, 150 ml for each oral administration, and 4 weeks is a treatment course.

[0085] II. Application examples

[0086] Zhao, male, 75 years old, from Beihai. His memory has declined for 1 month. Present symptoms: forgetfulness, often forgetting what just happened, dizziness, tinnitus, soreness and weakness of the waist and knees, pale tongue, thin white coating, and thready and weak pulse. After being treated with the medicine in Example 1 according to the present invention for 1 treatment course, the patient's forgetfulness was significantly improved compared with before.

[0087] Liang, female, 72 years old, from Nanning. Her comprehension ability has declined for half a year. Clinically diagnosed with AD. Present symptoms: decline in comprehension and calculation abilities, slow speech, dull expression, soreness and weakness of the waist and knees, frequent urination at night, pale tongue, white and greasy coating, and slippery pulse. After being treated with the medicine in Example 3 according to the present invention for 1 treatment course, the patient's comprehension and calculation abilities and speech dementia were significantly improved compared with before.

[0088] Huang, male, 77 years old, from Nanning. The patient's gait has been unstable and limb coordination ability has declined for more than 1 month. Present symptoms: unstable gait, decline in limb coordination ability, staggering, apathy, dizziness, tinnitus, dementia and dreaminess, pale tongue with thin white coating, and thready and weak pulse. After being treated with the medicine in Example 2 according to the present invention for 1 treatment course, the patient's limb coordination ability was significantly improved, and the symptoms of dizziness and dementia completely disappeared.

[0089] III. Clinical research

[0090] 1. Medical record data

[0091] 1.1 Number of selected patients

[0092] 70 dementia patients were selected.

[0093] 1.2 Diagnostic criteria

[0094] 1.2.1 Diagnostic criteria for Alzheimer's disease (AD)

[0095] Regarding the diagnostic criteria for Alzheimer's disease. The patient's daily work and general activity abilities are impaired; the living ability is significantly declined; there are personality and behavioral abnormalities; it cannot be explained by other mental diseases such as delirium and depression; the onset is insidious and the condition gradually worsens; two or more of the cognitive functions such as language ability and comprehension ability are damaged; the dementia symptoms are not caused by other diseases.

[0096] 1.2.2 Diagnostic criteria for dementia of the type of insufficiency of the marrow sea

[0097] Refer to the diagnostic criteria for the syndrome of insufficient marrow sea in the Guidelines for the Diagnosis and Treatment of Common Diseases in Traditional Chinese Internal Medicine: Western Medicine Diseases. Main symptoms: senile dementia, decline in intelligence, forgetfulness in dealing with things, and weakened recent memory; secondary symptoms: dizziness, soreness and weakness of the waist and knees, and difficulty in walking; tongue and pulse: thin and pale tongue body, white coating, and deep, thready and weak pulse. The diagnosis can be confirmed by meeting 1 or more main symptoms plus 2 secondary symptoms, with reference to the tongue and pulse.

[0098] 1.3 Inclusion criteria for cases

[0099] (1) Meet the diagnostic criteria for dementia in both traditional Chinese and Western medicine;

[0100] (2) Age ≥ 60 years old;

[0101] (3) Have not taken traditional Chinese patent medicines, decoctions or related Western medicines for the treatment of dementia within 2 weeks;

[0102] (4) Approved by the hospital ethics committee, and the family members of the enrolled patients must sign the informed consent;

[0103] (5) Voluntary participants and sign the informed consent form;

[0104] (6) Understand the content of the scale and actively cooperate with the treatment.

[0105] 1.4 Exclusion criteria for cases

[0106] Those with any of the following situations are excluded:

[0107] Dementia caused by other factors, such as vascular dementia; those with severe insufficiency of heart, liver and kidney functions; those with malignant tumors; those with mental diseases such as schizophrenia; those allergic to the drugs used in this study; those who have received anti-dementia or psychotropic drugs within the past 3 months.

[0108] 1.5 Criteria for exclusion and withdrawal

[0109] (1) Those who are found to not meet the inclusion criteria after inclusion and are misselected;

[0110] (2) The condition of the subjects does not reach the expected control level within a certain period of time;

[0111] (3) Those who affect the judgment of curative effect, such as not taking drugs as prescribed or incomplete clinical data, etc.;

[0112] (4) Those who, for various reasons, voluntarily request to withdraw from the trial;

[0113] (5) Those who develop serious other concurrent diseases during the research process;

[0114] (6) Those who take other drugs that may affect the evaluation of curative effect during the research period.

[0115] 2. Methods

[0116] 2.1 Treatment method

[0117] 70 patients with vertigo were randomly divided into 2 groups, with 35 patients in each group. The random grouping method with envelope concealment was used. 70 sealed envelopes with information about the treatment group or the control group were randomly shuffled by personnel outside the research group, and the patients were grouped according to the information in the envelopes they randomly drew. The control group was given memantine hydrochloride capsules orally, and the treatment group was given the oral decoction of the Marrow-Filling and Mind-Calming Prescription in Example 3 (the traditional Chinese medicine compound composition prepared by the present invention). There were no significant differences in the general data statistics of the two groups of patients, and the two groups were comparable for comparison.

[0118] Control group: Oral administration of memantine hydrochloride capsules (Shanghai Green Valley Pharmaceutical Co., Ltd.), orally, 450 mg each time, twice a day, for 4 weeks.

[0119] Treatment group: Oral administration of the preparation of the Marrow-Filling and Mind-Calming Prescription in Example 3. The formula: 20 parts of Ganoderma lucidum, 20 parts of Rosa laevigata Michx., 20 parts of longan aril, 20 parts of Rhizoma Dioscoreae Oppositae, 20 parts of Ficus hirta Vahl. It was decocted in the traditional Chinese medicine pharmacy of the International Zhuang Medicine Hospital Affiliated to Guangxi University of Chinese Medicine. Each dose was decocted to obtain 450 ml of juice, and 150 ml was taken each time. It was taken warm about half an hour after breakfast and dinner, for 4 weeks.

[0120] 2.2 Observation indicators and scoring criteria

[0121] 2.2.1 Cognitive assessment

[0122] The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) was used for scoring.

[0123] 2.2.2 Intelligence assessment

[0124] The Modified Hasegawa Dementia Scale (HDS-R) was used for scoring.

[0125] 2.2.3 Dementia degree assessment

[0126] The Clinical Dementia Rating Scale (CDR) was used for scoring.

[0127] 2.2.4 Efficacy determination

[0128] It was formulated with reference to the "Diagnosis and Treatment Guidelines for Alzheimer's Disease (2020 Edition)". Marked effect: The clinical symptoms of the patient disappeared, the mental state was good, normal communication was possible, the ability of daily life was restored, and the score of the Mini-Mental State Examination (MMSE) increased by more than 50%. Effective: The clinical symptoms of the patient were relieved, the mental state was average, communication was possible but there were certain obstacles, the ability of daily life was somewhat restored, and the MMSE score increased by 25 - 50%. Ineffective: The clinical symptoms of the patient were not relieved, the mental state was not improved, there were serious obstacles in communication and living ability, and the MMSE score increased by less than 25%.

[0129] Efficiency = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%.

[0130] 2.3 Combined medication

[0131] Avoid using traditional Chinese patent medicines for treating dementia. For other co - morbidities, symptomatic medication can be used on the premise that it does not affect the evaluation of the efficacy of the research drug.

[0132] 2.4 Data processing

[0133] All data were analyzed using SPSS 26.0 statistical software. Measurement data were expressed as mean ± standard deviation (x ± s). Normal distribution tests were performed on the two groups of data. For data conforming to normal distribution, independent - sample t - tests were used; for data not conforming to normal distribution, non - parametric tests were used. Count data were expressed as frequency and percentage, and chi - square tests and rank - sum tests were used. A P < 0.05 indicated a significant difference.

[0134] 3. Results

[0135] 3.1 Comparison results of the total cognitive assessment score ((ADAS - cog)) before and after treatment in the two groups

[0136] There was no significant statistical difference in the total cognitive assessment score between the two groups before treatment. After treatment, the total cognitive assessment score of the treatment group was significantly lower than that of the control group (P < 0.05), as shown in Table 1.

[0137] Table 1 Comparison of the total cognitive assessment score before and after treatment in the two groups (score)

[0138]

[0139] 3.2 Comparison results of the HDS - R score before and after treatment in the two groups

[0140] There was no significant statistical difference in the HDS - R score between the two groups before treatment. After treatment, the HDS - R score of the treatment group was significantly higher than that of the control group (P < 0.05), as shown in Table 2.

[0141] Table 2 Comparison of the HDS - R score before and after treatment in the two groups (score)

[0142]

[0143]

[0144] 3.3 Comparison results of the CDR scale ratings before and after treatment in the two groups

[0145] Through the rank - sum test results, in the CDR scale scores of the treatment group, the proportion of moderate and severe dementia in the treatment group was significantly lower than that of the control group (P < 0.05), as shown in Table 3.

[0146] Table 3 Comparison of CDR scale ratings between two groups before and after treatment( points)

[0147]

[0148] 3.4 Results of efficacy evaluation after treatment in two groups

[0149] As can be seen from Table 4, the effective rate of the treatment group was as high as 88.57%, significantly higher than 68.57% of the control group (P < 0.05), and the number of cured and markedly effective patients was significantly higher than that of the control group.

[0150] Table 4 Results of efficacy evaluation after treatment in two groups

[0151]

[0152] 4. Safety

[0153] Thirty-five patients in the treatment group took the traditional Chinese medicine in this study. The patients had high compliance. Biochemical examinations showed no abnormal changes in blood routine, routine urine and stool tests, and had no adverse effects on liver and kidney functions. No obvious toxic and side effects were found. It was safe and reliable to take and had significant curative effects, further indicating that the traditional Chinese medicine compound composition of the phlegm-resolving and resuscitation-inducing prescription of the present invention has good market application prospects.

[0154] IV. Comparative test on treatment effects of Examples 1-3 and Comparative Examples 1 and 2

[0155] By the random number table method, the statistician used SPSS 26.0 software to generate a random number table, and divided 210 patients into 6 groups, with 35 patients in each group, corresponding to Examples 1-4 and Comparative Examples 1 and 2 respectively. It was stipulated that the enrollment, filling of the first score sheet, filling of the last score sheet, and data analysis were completed by four different physicians respectively, and the four physicians were prohibited from communicating patient information. The results of efficacy evaluation after treatment are shown in Table 5 below.

[0156] Table 5 Results of efficacy evaluation after treatment of Examples 1-4 and Comparative Examples 1 and 2

[0157]

[0158] As can be seen from Table 5 above

[0159] (1) The effective rates of Implementations 1-4 were 94.29%, 91.43%, 88.57%, and 85.71% respectively. It can be seen that the curative effect of Example 1 was the best. As the serial number of the examples increased, the overall effective rate showed a downward trend, but the effective rates of all examples were above 85%. After a large number of practical verifications, the traditional Chinese medicine compound drug of the present invention performed well in clinical medical practice, with the cure rate and effective rate being quite remarkable, and the effective rate far exceeding the average level of similar drugs such as orally administered sodium D-mannuronate capsules. This achievement not only brought hope for recovery to patients but also met the clinical needs of medical institutions, having important application value in the medical field.

[0160] (2) Through systematic analysis of the treatment effect data of Examples 1-4 and Comparative Examples 1 and 2, the correlation between the raw material ratio and the curative effect of the drug of the present invention was clearly presented. The study found that when the weight ratio of Ganoderma lucidum, Rosa laevigata Michx., Arillus longan, Rhizoma Dioscoreae Oppositae, and Ficus hirta Vahl as the core medicinal materials was maintained in the range of (16-22):(19-24):(18-23):(17-24):(19-25), the drug could exert the best treatment effect. When the ratio deviated from this range, both the cure rate and the effective rate of the drug decreased significantly. This result highlighted the significance of precisely controlling the proportion of raw material dosage in ensuring the curative effect of the drug. In future drug research and development, the basic research on traditional Chinese medicine compounds should be further deepened, and modern scientific and technological means such as artificial intelligence algorithms should be comprehensively used to explore the optimal solution of the medicinal material ratio. By establishing an intelligent quality control system, the precise dispensing of the medicinal material dosage can be realized, thus promoting the development of the traditional Chinese medicine industry towards standardization and scientification.

[0161] The above examples only illustratively explain the principle and its efficacy of the present invention, rather than being used to limit the present invention. Any person familiar with this technology can modify or change the above examples without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or changes completed by those with ordinary knowledge in the technical field without departing from the spirit and technical idea disclosed by the present invention should still be covered by the claims of the present invention.

Claims

1. A Chinese medicinal compound composition for treating marrow sea insufficiency type dementia, characterized in that: The invention comprises the following raw materials in parts by weight: 16-22 parts of ganoderma lucidum, 19-24 parts of golden cherry fruit, 18-23 parts of longan pulp, 17-24 parts of yam, and 19-25 parts of quinquefolius.

2. The Chinese medicinal compound composition for treating marrow sea insufficiency type dementia according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 20 parts of ganoderma lucidum, 20 parts of golden cherry fruit, 20 parts of longan pulp, 20 parts of yam and 20 parts of quinquefolius.

3. The Chinese medicinal compound composition for treating marrow sea insufficiency type dementia according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 19 parts of ganoderma lucidum, 21 parts of golden cherry fruit, 22 parts of longan pulp, 23 parts of yam and 22 parts of quinquefolius.

4. The Chinese medicinal compound composition for treating marrow sea insufficiency type dementia according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 17 parts of ganoderma lucidum, 22 parts of golden cherry fruit, 21 parts of longan pulp, 22 parts of yam and 23 parts of quinquefolius.

5. The Chinese medicinal compound composition for treating marrow sea insufficiency type dementia according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 21 parts of ganoderma lucidum, 19 parts of golden cherry fruit, 19 parts of longan pulp, 21 parts of yam and 22 parts of quinquefolius.

6. The Chinese medicinal compound composition for treating marrow sea insufficiency type dementia according to any one of claims 1 to 5, characterized in that: The Chinese medicine compound composition is used orally.

7. The Chinese medicinal compound composition for treating marrow sea insufficiency type dementia according to claim 6, characterized in that: Take it orally, once in the morning and once in the evening half an hour after meals, warmed up.

8. The Chinese medicinal compound composition for treating marrow sea insufficiency type dementia according to claim 7, characterized in that: The dosage of the Chinese medicine compound composition is 150 ml each time, and 4 weeks is regarded as a complete treatment cycle.

9. A method for preparing a Chinese medicinal compound composition for treating marrow sea insufficiency type dementia according to any one of claims 1 to 8, characterized in that: The following steps are involved: a. According to the predetermined weight ratio, accurately weigh the dried Ganoderma lucidum, Rosa laevigata, pitted longan pulp, sliced ​​Chinese yam and cut Prunus armeniaca; b. Put the weighed Chinese medicinal materials into a proper amount of water, decoct and extract the effective ingredients, and finally prepare a Chinese medicinal compound liquid for treating dementia.

10. The method for preparing the Chinese medicinal compound composition for treating marrow sea insufficiency type dementia according to claim 9, characterized in that: In step b, the amount of clean water is clearly 500 ml.

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