Traditional Chinese medicine composition for Lewy body dementia and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for Lewy body dementia and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 20 to 30 parts of herba cistanche, 10 to 20 parts of radix morindae officinalis, 20 to 30 parts of roasted turtle shell, 10 to 20 parts of radix rehmanniae preparata, 10 to 20 parts of radix polygoni multiflori, 20 to 30 parts of calcined oyster shell, 20 to 30 parts of fossil fragments, 20 to 30 parts of radix paeoniae alba, 5 to 15 parts of rhizoma gastrodiae, 20 to 30 parts of ramulus uncariae cum uncis, 10 to 15 parts of radix angelicae sinensis, 15 to 20 parts of radix polygalae, 15 to 20 parts of rhizoma acori graminei, 15 to 20 parts of semen ziziphi spinosae, 10 to 20 parts of caulis polygoni multiflori and 20 to 30 parts of fructus alpiniae oxyphyllae. The traditional Chinese medicine composition focuses on the characteristic that patients are old people and deficient people, is mainly used for warming and tonifying kidney essence, nourishing water and containing wood, has the effects of tonifying kidney and replenishing essence, filling marrow sea, calming nerves and calming nerves, has the effects of warming kidney and replenishing essence, calming liver and suppressing yang, and benefiting intelligence and calming nerves, and can effectively relieve clinical symptoms of patients.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for dementia with Lewy bodies and a preparation method thereof. Background Art

[0002] Dementia with Lewy bodies (DLB) is the second most common degenerative dementia type in the elderly population clinically, second only to Alzheimer's disease (AD). It has caused inestimable economic and social burdens to families and society and has increasingly attracted wide attention. The pathological characteristics of DLB are as follows: Lewy bodies (LB) appear in neurons, astrocyte cytoplasm, and microglia cytoplasm in the cerebral cortex, brainstem, and cerebellum. In recent years, studies have found that the four core clinical features of DLB are: fluctuating cognitive impairment, visual hallucinations, Parkinson's syndrome, and rapid eye movement sleep behavior disorder (RBD), which persist throughout the disease course. Recent studies have shown that: with the increase in age, the incidence and prevalence of DLB are gradually increasing. In addition, the disease progression rate of DLB patients is faster than that of AD, and the survival period is shorter than that of AD.

[0003] Currently, there is no effective treatment method or drug for DLB. Western medicine has limited treatment means for DLB, mainly symptomatic drug treatment, with poor efficacy and many adverse reactions. Therefore, in recent years, traditional Chinese medicine has tried to explore treatment methods for DLB.

[0004] The article "Discussion on Dementia with Lewy Bodies from the Perspectives of Brain Marrow - Brain Spirit - Brain Qi" in the 16th volume, 10th issue of Global Traditional Chinese Medicine in October 2023 discloses a traditional Chinese medicine prescription for dementia with Lewy bodies: 25 g of Cistanche deserticola, 10 g of Morinda officinalis, 15 g of Cornus officinalis, 15 g of Polygonum multiflorum, 12 g of Ganoderma lucidum, 12 g of Tribulus terrestris, 15 g of Gastrodia elata, 30 g of Acorus tatarinowii, 15 g of Pueraria lobata, 12 g of Pinellia ternata, 6 g of Bambusa textilis var. gracilis, 12 g of Astragalus complanatus, 15 g of Broussonetia papyrifera, 12 g of Forsythia suspensa, 12 g of Coptis chinensis, 9 g of Gardenia jasminoides, 12 g of Panax notoginseng, 15 g of Sinomenium acutum, 20 g of Chlorite Schist, 30 g of Poria cum Radix Pini, and 15 g of Magnetitum.

[0005] The article "Etiology, Pathogenesis, Syndrome Differentiation and Treatment of Traditional Chinese Medicine for Dementia with Lewy Bodies" in Jilin Journal of Traditional Chinese Medicine, Vol. 41, No. 5, May 2021, discloses a traditional Chinese medicine prescription for dementia with Lewy bodies: 30g of raw rehmannia root, 30g of prepared rehmannia root, 30g of cornelian cherry fruit processed with wine, 20g of cistanche processed with wine, 10g of schisandra chinensis, 20g of angelica sinensis, 30g of codonopsis pilosula, 30g of atractylodes macrocephala, 15g of licorice root, 15g of platycodon grandiflorum, 45g of astragalus membranaceus, 10g of gastrodia elata, half a centipede, 30g of raw fossil fragments, 30g of calcined chlorite-schist, 20g of magnetite, 15g of anemarrhena asphodeloides, 20g of phellodendron amurense.

[0006] However, the traditional Chinese medicine prescriptions in the above-mentioned literature are all used for individual outpatients, lacking a large amount of case information to track long-term efficacy, and the treatment effect remains to be verified, with poor universality. Summary of the Invention

[0007] In view of the above problems, the present invention aims to provide a traditional Chinese medicine composition for dementia with Lewy bodies and its preparation method, which dialectically treats according to the symptom types and characteristics of DLB and has a significant curative effect.

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

[0009] A traditional Chinese medicine composition for dementia with Lewy bodies, comprising the following components: cistanche deserticola, morinda officinalis, stir-fried turtle shell, prepared rehmannia root, polygonum multiflorum, calcined oyster, fossil fragments, white peony root, gastrodia elata, uncaria rhynchophylla, angelica sinensis, polygala tenuifolia, acorus tatarinowii, wild jujube seed, polygonum multiflorum thunbergii, and fructus alpiniae oxyphyllae;

[0010] The weight parts of different components are respectively: cistanche deserticola 20 - 30, morinda officinalis 10 - 20, stir-fried turtle shell 20 - 30, prepared rehmannia root 10 - 20, polygonum multiflorum 10 - 20, calcined oyster 20 - 30, fossil fragments 20 - 30, white peony root 20 - 30, gastrodia elata 5 - 15, uncaria rhynchophylla 20 - 30, angelica sinensis 10 - 15, polygala tenuifolia 15 - 20, acorus tatarinowii 15 - 20, wild jujube seed 15 - 20, polygonum multiflorum thunbergii 10 - 20, and fructus alpiniae oxyphyllae 20 - 30.

[0011] Preferably, the weight parts of different components are respectively: cistanche deserticola 30, morinda officinalis 20, stir-fried turtle shell 20, prepared rehmannia root 20, polygonum multiflorum 20, calcined oyster 20, fossil fragments 25, white peony root 20, gastrodia elata 15, uncaria rhynchophylla 20, angelica sinensis 15, polygala tenuifolia 15, acorus tatarinowii 20, wild jujube seed 20, polygonum multiflorum thunbergii 15, and fructus alpiniae oxyphyllae 20.

[0012] The pharmacology of each component is as follows:

[0013] Cistanche deserticola, morinda officinalis, stir-fried turtle shell, prepared rehmannia root, polygonum multiflorum: enter the liver and kidney meridians, tonify the kidney and replenish essence, and fill the marrow sea;

[0014] Calcined oyster, fossil fragments: astringe and secure, calm the mind with heavy substances, soften hardness and dissipate binds, and relieve gastric hyperacidity and pain;

[0015] Peony: nourishes blood and nourishes blood, astringes yin and calms the liver, relieves urgency and stops pain;

[0016] Gastrodia elata: pungent, warm; enters the liver meridian, calms wind, and calms convulsions;

[0017] Uncaria rhynchophylla: sweet in nature and flavor, slightly cold; enters the liver and pericardium meridians; relieves wind and stops spasms, clears heat and soothes the liver;

[0018] Angelica: sweet and pungent, warm; enters the heart, liver, and spleen meridians; nourishes and regulates blood, regulates menstruation and relieves pain, moisturizes and lubricates the intestines;

[0019] Polygala: Polygala is bitter and pungent in taste; warm in nature, enters the heart, kidney, and lung meridians; soothes the mind, improves intelligence, removes phlegm and opens the mind;

[0020] Acorus calamus: calms the mind, dispels wind and resolves phlegm, awakens the spirit and improves intelligence;

[0021] Ziziphus jujuba seeds and Polygonum multiflorum: nourish the heart and liver, soothe the mind and calm the nerves, and reduce sweating and promote body fluid production;

[0022] Alpinia oxyphylla: promotes development, resists aging, nourishes the kidney and strengthens yang, consolidates essence and reduces urine, warms the spleen and stops diarrhea, improves complexion and prolongs life, and improves memory, immunity and sexual ability.

[0023] Furthermore, a method for preparing a Chinese medicine composition for Lewy body dementia comprises the following steps:

[0024] S1: Take the formula amount of calcined oyster, dragon bone and roasted turtle, record it as component A; take the formula amount of Cistanche deserticola, Morinda officinalis, roasted turtle shell, Rehmannia glutinosa, Polygonum multiflorum, calcined oyster, dragon bone, white peony root, Gastrodia elata, Uncaria rhynchophylla, Angelica sinensis, Polygala tenuifolia, Acorus calamus, Ziziphus jujuba seed, Polygonum multiflorum, Alpinia oxyphylla seed, record it as component B;

[0025] S2: Add cold water to component A and component B until the medicinal materials are covered by 3-5 cm, and soak for 30 minutes;

[0026] S3: After the soaked component A is heated to a boil, it is simmered for 30 minutes over a low heat, and then the pre-soaked component B is added, and 500 ml of warm water is added, and the mixture is heated to a boil, and then simmered for 30 minutes over a low heat, and filtered to obtain a primary filtrate;

[0027] S4: Add 0.9-1L warm water to the casserole, continue to boil over high heat, simmer for 30 minutes over low heat, and filter to obtain secondary filtrate;

[0028] S5: Combine the first filtrate and the second filtrate, heat and concentrate to 400 ml.

[0029] The beneficial effects of the present invention are as follows: compared with the prior art, the present invention has the following improvements:

[0030] The traditional Chinese medicine composition of the present invention is composed of Cistanche deserticola, Morinda officinalis, stir-fried turtle shell, Rehmannia glutinosa, Polygonum multiflorum, calcined oyster, dragon bone, Paeonia lactiflora, Gastrodia elata, Uncaria rhynchophylla, Angelica sinensis, Polygala tenuifolia, Acorus tatarinowii, Ziziphus jujuba var. spinosa, Polygonum multiflorum Thunb., and Alpinia oxyphylla. In the formula, Cistanche deserticola, Morinda officinalis, stir-fried turtle shell, Rehmannia glutinosa, and Polygonum multiflorum enter the liver and kidney meridians, tonify the kidney and replenish essence, and fill the marrow sea; calcined oyster, dragon bone, Polygala tenuifolia, Acorus tatarinowii, Ziziphus jujuba var. spinosa, and Polygonum multiflorum Thunb. are all good at calming the mind; Paeonia lactiflora and Uncaria rhynchophylla are good at suppressing the hyperactive liver. The location of Lewy body dementia is in the brain, and the root cause of the disease is kidney deficiency with reduced marrow and loss of the function of the mental mechanism. The kidney qi, essence, and blood are insufficient and unable to produce marrow. If the marrow sea is empty and the brain loses the function of the mental mechanism, dementia will occur. Starting from the characteristics that the patients are the elderly and the weak, the present invention focuses on warming and tonifying the kidney essence and nourishing water to support wood, tonifying the kidney and replenishing essence, filling the marrow sea, calming the mind and stopping hallucinations, and jointly achieving the effects of warming the kidney and replenishing essence, suppressing the hyperactive liver and calming the yang, and improving intelligence and calming the mind. It can effectively relieve the clinical symptoms of patients and is worthy of popularization and application. Detailed implementation mode

[0031] In order to enable those of ordinary skill in the art to better understand the technical solutions of the present invention, the technical solutions of the present invention will be further described below in conjunction with embodiments.

[0032] A traditional Chinese medicine composition for Lewy body dementia, comprising the following components: Cistanche deserticola, Morinda officinalis, stir-fried turtle shell, Rehmannia glutinosa, Polygonum multiflorum, calcined oyster, dragon bone, Paeonia lactiflora, Gastrodia elata, Uncaria rhynchophylla, Angelica sinensis, Polygala tenuifolia, Acorus tatarinowii, Ziziphus jujuba var. spinosa, Polygonum multiflorum Thunb., and Alpinia oxyphylla.

[0033] The weight parts of different components are respectively: Cistanche deserticola 30, Morinda officinalis 20, stir-fried turtle shell 20, Rehmannia glutinosa 20, Polygonum multiflorum 20, calcined oyster 20, dragon bone 25, Paeonia lactiflora 20, Gastrodia elata 15, Uncaria rhynchophylla 20, Angelica sinensis 15, Polygala tenuifolia 15, Acorus tatarinowii 20, Ziziphus jujuba var. spinosa 20, Polygonum multiflorum Thunb. 15, and Alpinia oxyphylla 20.

[0034] The preparation method of the traditional Chinese medicine composition comprises the following steps:

[0035] S1: Take the formula amount of calcined oyster, dragon bone, and stir-fried turtle shell, denoted as component A; take the formula amount of Cistanche deserticola, Morinda officinalis, stir-fried turtle shell, Rehmannia glutinosa, Polygonum multiflorum, calcined oyster, dragon bone, Paeonia lactiflora, Gastrodia elata, Uncaria rhynchophylla, Angelica sinensis, Polygala tenuifolia, Acorus tatarinowii, Ziziphus jujuba var. spinosa, Polygonum multiflorum Thunb., and Alpinia oxyphylla, denoted as component B;

[0036] S2: Add cold water to cover the medicinal materials by 3 - 5 cm for components A and B, and soak for 30 minutes;

[0037] S3: After boiling the soaked component A, continue to simmer over low heat for 30 minutes, then add the pre-soaked component B liquid medicine, add 500 ml of warm water, bring to a boil and then simmer over low heat for another 30 minutes, and filter to obtain the first filtrate;

[0038] S4: Add 0.9 - 1 L of warm water to the earthenware pot, continue to bring to a boil over high heat, then decoct over low heat for 30 minutes, and filter to obtain the secondary filtrate;

[0039] S5: Combine the primary filtrate and the secondary filtrate, and concentrate by heating to 400 ml to obtain the product.

[0040] Furthermore, the traditional Chinese medicine composition in the present invention is used for the treatment of dementia with Lewy bodies, and the clinical effect is good. The specific clinical experimental report is as follows.

[0041] Clinical Report:

[0042] 1 General Information

[0043] Sixty DLB patients in the outpatient and inpatient departments of the Department of Neurology of our hospital from October 2019 to September 2024 were selected and divided into a treatment group and a control group by a random, double - blind, placebo parallel - controlled method.

[0044] 2 Diagnostic Criteria

[0045] Western Medicine Diagnostic Criteria: Diagnosed during the outpatient and inpatient periods in the Department of Neurology of our hospital, meeting the following criteria: According to the "Fourth Edition Diagnostic Criteria" formulated by the DLB International Working Group in 2017, diagnosed as probable DLB, that is, having 2 or more core clinical features, with or without suggestive biomarkers, or 1 core clinical feature plus suggestive biomarkers. Analyze the clinical symptoms, neurological physical examinations, Mini - Mental State Examination (MMSE), cranial imaging examinations, electroencephalograms, apolipoprotein E (APOE) gene tests, lumbar puncture cerebrospinal fluid examinations and other auxiliary examinations, as well as drug treatments of all patients.

[0046] Traditional Chinese Medicine Syndrome Differentiation Criteria: Refer to the "Diagnosis, Syndrome Differentiation Typing and Efficacy Evaluation Criteria for Senile Dementia" to formulate the traditional Chinese medicine syndrome differentiation criteria for the type of insufficient marrow in the sea of marrow of dementia syndrome. Expression is dull, dizziness and tinnitus, lazy and lethargic, hair is withered, bones are soft and weak, tongue is pale with white coating, pulse is deep, thin and weak, and the pulses at both cubital positions are weak.

[0047] Inclusion Criteria

[0048] (1) Aged 40 - 80 years old, gender is not limited; (2) Meeting the DLB diagnostic criteria and the traditional Chinese medicine syndrome differentiation criteria for the type of insufficient marrow in the sea of marrow in the above - mentioned Fourth Edition Diagnostic Criteria; (3) Obtaining the informed consent of the patient or family member and signing the informed consent form.

[0049] 3 Withdrawal and Exclusion Criteria

[0050] Potential subjects meeting the inclusion criteria will be withdrawn or excluded if they meet any of the following:

[0051] Withdrawal (Drop-off) Criteria: (1) Patients withdraw on their own initiative; (2) Loss to follow-up; (3) The researcher advises them to withdraw (poor compliance, occurrence of severe co-morbidities or complications, serious adverse events); (4) Although the trial is completed, the dosage of the drug is not within the range of 80%-120% of the prescribed dosage; (5) Those with unblinding or emergency unblinding.

[0052] Exclusion Criteria: (1) Failure to take the trial drug as required; (2) After the start of treatment, it is found that the patient does not meet the inclusion and exclusion criteria; (3) Compliance <80% or >120%; (4) Taking prohibited drugs as stipulated in the protocol during the observation period.

[0053] 4 Methods

[0054] For those who have not taken Western medicine yet, the application of Western medicine is postponed and traditional Chinese medicine treatment is directly given. For those who have already taken Western medicine, traditional Chinese medicine is added on the basis of the original dosage and usage of the Western medicine. The treatment group is given the traditional Chinese medicine granules made from the traditional Chinese medicine composition in the present invention (30 grams of Cistanche deserticola, 20 grams of Morinda officinalis, 20 grams of roasted Trionyx sinensis carapace, 20 grams of Rehmannia glutinosa, 20 grams of Polygonum multiflorum, 20 grams of calcined Oyster, 25 grams of Dragon Bone, 20 grams of White Peony Root, 15 grams of Gastrodia elata, 20 grams of Uncaria rhynchophylla, 15 grams of Angelica sinensis, 15 grams of Polygala tenuifolia, 20 grams of Acorus tatarinowii, 20 grams of Ziziphus jujuba var. spinosa, 15 grams of Polygonum multiflorum Thunb. var. caudatum, 20 grams of Alpinia oxyphylla), and the control group is given traditional Chinese medicine placebo granules (auxiliary materials such as starch, dextrin and bitter agents, with the same shape, color, smell, taste, texture and packaging appearance as the traditional Chinese medicine granules of the treatment group. Our hospital makes them into instant granules, 8g / bag), 1 bag each time, 2 times a day, taken orally in the morning and evening. The treatment course for both groups is 12 weeks, and follow-up is conducted at 4, 8, and 12 weeks of treatment respectively.

[0055] Combined Medication: During the treatment period, Parkinson's disease drugs that can be converted into the dosage of levodopa (such as donepezil, memantine, levodopa-carbidopa tablets, carbidopa-levodopa controlled-release tablets, dopamine receptor agonists, monoamine oxidase inhibitors, COMT inhibitors) can be added or reduced.

[0056] 5 Observation Indicators

[0057] 5.1 Evaluation of Traditional Chinese Medicine Efficacy

[0058] Mini-Mental State Examination (MMSE) score, Activities of Daily Living Scale (ADL); among them, the scoring method of ADL is usually to observe and inquire about the daily activity ability of the evaluated person, and then score according to the scoring standard. The higher the total score, the stronger the daily activity ability, and vice versa.

[0059] 5.2 Statistical Methods

[0060] The clinical efficacy was determined according to the reduction rate of the Scale for Outcomes in Parkinson's Disease - Autonomic (SCOPA - AUT). Reduction rate (%) = (score before treatment - score after treatment) / score before treatment × 100%. A reduction rate of 75% was defined as cure, 50% - 74% as marked effect, 25% - 49% as improvement, and < 25% as no effect.

[0061] 6 Results

[0062] 6.1 Comparison of the effective rates of MMSE scores between the two groups

[0063] After 12 weeks of treatment, the marked effective rate of the treatment group was 46.67%, and that of the control group was 20.00%; the total effective rate of the treatment group was 73.33%, and that of the control group was 46.67%. The treatment group was superior to the control group (P < 0.05), as shown in Table 1 below.

[0064] Table 1 Comparison of the curative effects between the two groups of patients [n (%)]

[0065]

[0066] Note: Compared with the control group at the same time point, ΔP < 0.05

[0067] 6.2 Comparison of the ADL curative effects between the two groups

[0068] Compared with before treatment, there was no significant difference in the ADL scores of the control group at each time point (P > 0.05), while the ADL scores of the treatment group decreased significantly (P < 0.05). The ADL scores of the treatment group during treatment were significantly lower than those of the control group (P < 0.05), as shown in Table 2.

[0069] Table 2 Comparison of the ADL scores between the two groups of patients

[0070]

[0071] Note: Compared with before treatment in the same group, *P < 0.05; compared with the control group at the same time point, △P < 0.05.

[0072] 6.3 Records of the MMSE scores and ADL curative effects of the two groups are shown in Table 3

[0073] Table 3 Records of the MMSE scores and ADL curative effects of the two groups of patients

[0074]

[0075]

[0076] 7 Discussion

[0077] 7.1 Pharmacological effects

[0078] Cistanche deserticola, Morinda officinalis, roasted turtle shell, Rehmannia glutinosa, Polygonum multiflorum: enter the liver and kidney meridians, replenish the kidney and essence, fill the sea of ​​marrow, and the brain is full of spirit. If the sea of ​​marrow is insufficient, the marrow will be reduced and the brain will be lost, and the thinking will be slow. In severe cases, symptoms such as dementia, dizziness, tinnitus, blurred vision, premature graying of hair and beard, and weakness of waist and knees will appear. In recent years, modern medical research has also shown that Chinese medicine "tonifying the kidney and filling the marrow" can improve the energy metabolism and utilization efficiency of neurons in the brain, and can stimulate the production of brain-derived neurotrophic factor, inhibit and reduce the production of related neurotoxins, and thus inhibit the death and apoptosis of nerve cells.

[0079] Calcined oyster and dragon bone: astringent, calming, soothing, softening and dispersing nodules, relieving acidity and relieving pain. In clinical practice, calcined oyster can relieve mental stress, relax people, and improve mental problems such as anxiety and depression.

[0080] Peony: It has the effects of nourishing blood and nourishing the body, astringing yin and calming the liver, relieving acute and acute pain; it is mainly used to treat: pain in the ribs and abdomen, metrorrhagia, night sweats, spontaneous sweating, cramps in the limbs, dizziness, headache, etc.

[0081] Gastrodia elata: spicy and warm in taste; enters the liver meridian, calms wind and soothes convulsions; treats dizziness, dark spots in the eyes, headaches, hemiplegia, numbness of limbs, etc.

[0082] Uncaria rhynchophylla: sweet in nature and slightly cold; enters the liver and pericardium meridians; has the effects of calming wind and stopping convulsions, clearing away heat and calming the liver, and has a mild effect of calming wind and stopping convulsions. It is a commonly used medicine for treating epilepsy and convulsions caused by internal liver wind, and is often used in combination with Gastrodia elata; Uncaria rhynchophylla clears liver heat and calms the liver and suppresses yang, so it can be used to treat diseases such as headache and dizziness caused by liver fire or hyperactivity of liver yang.

[0083] Angelica: sweet and pungent, warm; enters the heart, liver, and spleen meridians; replenishes and harmonizes blood, regulates menstruation and relieves pain, moisturizes and lubricates the intestines; treats diseases such as blood deficiency headache, dizziness, paralysis, irregular menstruation, amenorrhea and abdominal pain, accumulation of masses, metrorrhagia, dry intestines and constipation, heaviness after dysentery, carbuncles, ulcers, and injuries from falls.

[0084] Acorus calamus and Polygala tenuifolia: Polygala tenuifolia tastes bitter and pungent; it is warm in nature and enters the heart, kidney and lung meridians; it has the effect of calming the mind and improving intelligence, and also has the effect of removing phlegm and opening the mind. Acorus calamus has the effect of calming the mind and calming the nerves, and also has the effect of removing wind and phlegm, refreshing the mind and improving intelligence. Modern research shows that both Polygala tenuifolia and Acorus calamus contain alkaloids, which can stimulate the central nervous system and enhance learning ability and attention. Polygala tenuifolia can improve memory, and Acorus calamus has the effect of improving cognitive function. The combination of these two medicines has the effect of enhancing memory and protecting neurons.

[0085] Ziziphus jujuba seed and Polygonum multiflorum: have the effects of nourishing the heart and liver, calming the mind and tranquilizing the nerves, and astringing sweat and promoting body fluid; they are mainly used to treat insomnia, palpitations and nightmares, physical weakness and sweating, and loss of body fluid and thirst; in addition, Ziziphus jujuba seed is widely used to treat insomnia, and it also has the effect of astringing sweat and tonifying deficiency.

[0086] Alpinia oxyphylla: It can promote development, resist aging, invigorate the kidney and strengthen yang, consolidate essence and reduce urination, warm the spleen and stop diarrhea, improve complexion and prolong life, enhance memory, and also improve immunity and sexual ability; It is mainly used for treating abdominal distension, poor appetite, loose stools, cold limbs, cold pain and weakness in the waist and knees, aversion to cold and cold limbs, spermatorrhea, enuresis, etc.

[0087] 7.2 Pharmacological Analysis

[0088] DLB does not have a disease name in traditional Chinese medicine. It belongs to the category of "dementia" in the brain system diseases of traditional Chinese medicine. At present, there are not many research and treatment methods for DLB in clinical traditional Chinese medicine. DLB did not have this disease name in ancient times. Modern doctors often refer to the theoretical basis of Alzheimer's disease for syndrome differentiation and treatment of this disease. They mainly use the theory of the five internal organs of traditional Chinese medicine as the center, and discuss its etiology and pathogenesis from the perspective of the five internal organs and conduct syndrome differentiation and treatment. "Lingshu·Hai Lun" says that "the brain is the sea of ​​marrow". The brain is the sea of ​​marrow, the brain marrow is the material basis of the brain, and the spirit is the external manifestation of the brain. It is formed by the innate essence and grows and matures with the continuous nourishment of the acquired essence. "Compendium of Materia Medica" records that "the brain is the house of the primordial spirit". Yuan means the origin. It is formed by the innate essence of parents, so it is the primordial spirit, which is the key to life. The primordial spirit resides in the brain and is manifested as the spirit machine. The spirit machine is the messenger of the primordial spirit, commanding and dominating various life activities of people. Zhang Xichun's "Medical Records of Chinese and Western Medicine" also records: "The brain is the sea of ​​marrow, where the marrow gathers... It is actually formed by the combination of the true yin and true yang in the kidneys." The brain marrow is the origin of the transformation of the primordial spirit and the residence of the brain spirit. When the sea of ​​marrow is full, the brain is nourished, the primordial spirit can be normally biochemical, and life activities can be carried out normally. The brain marrow is the body, and the spirit is the function. The brain is actually the spirit. The two complement each other and influence each other. The brain spirit is not nourished, the spirit is not used, and the intelligence, thinking activities and other abilities are reduced, which is an important cause of cognitive impairment. Kidney deficiency reduces the brain and the marrow, the marrow does not fill the bones, and the tendons and bones are not nourished, which will cause symptoms such as limb stiffness and stiffness. On the other hand, as the material basis of the brain, the brain marrow plays an important role in brain function. If the brain marrow is reduced, it cannot regulate the movement of the limbs, which can be seen as slow movement, balance problems and falls. The brain is the house of the primordial spirit. The primordial spirit means the beginning, the beginning and the root. It can control the mind and the five spirits. If the primordial spirit is not restored, the control will be lost, the mind will be disordered, and abnormal mental and emotional activities may occur. The brain is the house of the clear orifices, and evil cannot be accepted. The toxic evil will further aggravate the damage to the marrow and the spirit. The primordial spirit will first decline and then be exhausted, and eventually the body and spirit will be separated. Therefore, we should take into account both eliminating evil and calming the mind, so that the evil will go away and the mind will be at peace. Therefore, the location of this disease is in the brain, and the root of the disease is kidney deficiency and marrow reduction, and the use of the spirit is lost. There is a mixture of deficiency and excess, and the deficiency is the root. The kidney qi, essence and blood are insufficient, and the marrow cannot be produced. If the marrow sea is empty and the brain loses the use of the spirit, dementia will occur. The excess is the symptom, because the qi (qi stagnation or qi reversal), fire (fire heat or wind fire), phlegm (phlegm coagulation), stasis (blood stasis) and other evils block the brain, causing the mind to be dysfunctional and leading to dementia. The deficiency and excess pathogenesis often transform into each other. Qi stagnation, phlegm coagulation and blood stasis can transform into each other or be mixed. The three can also generate fire heat and disturb the upper body. Further development of fire heat can consume the liver and kidney yin essence, water cannot contain wood, yin cannot control yang, liver yang rises, and hyperactivity turns into fire and wind, and wind and fire disturbance aggravate dementia. Therefore, the treatment of this disease should take into account both deficiency and excess, and treat both the symptoms and the root cause.

[0089] The treatment should focus on the fact that the patients are elderly and weak, and focus on warming and nourishing the kidney essence, nourishing water and containing wood, nourishing the kidney and filling the essence, filling the sea of ​​marrow, calming the mind and stopping hallucinations. This prescription has the effects of warming the kidney and filling the essence, calming the liver and suppressing yang, and improving intelligence and calming the mind.

[0090] After combining the above-mentioned drugs, the present invention has a synergistic effect on the efficacy. This traditional Chinese medicine composition for treating DLB has the advantages of quick onset of effect, short treatment course, simple treatment method, low cost, and no side effects on the body. More than 30 patients with DLB were treated with this prescription, and good curative effects were obtained, with the effective rate reaching over 70%.

[0091] 8 Typical Cases

[0092] Case 1: Wang XX, female, 62 years old. Two years ago, the patient developed symptoms of bradykinesia and limb tremors, which initially mainly affected the upper limbs and then gradually spread to the lower limbs. Subsequently, symptoms such as cognitive impairment and dementia appeared. The patient was diagnosed with Parkinson's disease syndrome, and the symptoms could be temporarily controlled with Western medicine. As the disease progressed, visual hallucinations occurred, and the effect of the drugs became worse and worse. After taking the drugs of the present invention for two treatment courses, symptoms such as cognitive decline and visual hallucinations were alleviated. After continuing to take the drugs for two more treatment courses, the symptoms improved significantly. So far, the drugs have been discontinued for two years, and there has been no recurrence.

[0093] Case 2: He XX, male, 65 years old. One year ago, the patient gradually developed symptoms such as cognitive decline, getting lost when going out, and memory decline. Subsequently, limb stiffness and bradykinesia appeared, and the patient was diagnosed with Lewy body dementia. Subsequently, symptoms such as visual hallucinations and RBD appeared. Long-term treatment with various Western medicines had no obvious effect. After taking the drugs of the present invention for two treatment courses, the patient's visual hallucinations basically disappeared, the dementia symptoms were slightly alleviated, and the mood was stable, indicating initial curative effects. After continuing to take the drugs for two more treatment courses, the patient recovered well, with flexible limb movement and rare occurrence of head and hand tremors. So far, the drugs have been discontinued for one year, and there has been no recurrence.

[0094] The above has shown and described the basic principles, main features and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited by the above embodiments. The above embodiments and the descriptions in the specification only illustrate the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention will have various changes and improvements, and all these changes and improvements fall within the scope of the present invention claimed. The scope of protection claimed by the present invention is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for Lewy body dementia, characterized in that, It includes the following components: Cistanche deserticola, Morinda officinalis, stir-fried turtle shell, Rehmannia glutinosa, Polygonum multiflorum, calcined oyster, dragon bone, white peony root, Gastrodia elata, Uncaria rhynchophylla, Angelica sinensis, Polygala tenuifolia, Acorus tatarinowii, Ziziphus jujuba var. spinosa, Polygonum multiflorum Thunb. var. caudatum, Alpinia oxyphylla; The weight parts of different components are respectively: Cistanche deserticola 20 - 30, Morinda officinalis 10 - 20, stir-fried turtle shell 20 - 30, Rehmannia glutinosa 10 - 20, Polygonum multiflorum 10 - 20, calcined oyster 20 - 30, dragon bone 20 - 30, white peony root 20 - 30, Gastrodia elata 5 - 15, Uncaria rhynchophylla 20 - 30, Angelica sinensis 10 - 15, Polygala tenuifolia 15 - 20, Acorus tatarinowii 15 - 20, Ziziphus jujuba var. spinosa 15 - 20, Polygonum multiflorum Thunb. var. caudatum 10 - 20, Alpinia oxyphylla 20 - 30.

2. The traditional Chinese medicine composition for Lewy body dementia according to claim 1, wherein The weight parts of different components are respectively: Cistanche deserticola 30, Morinda officinalis 20, stir-fried turtle shell 20, Rehmannia glutinosa 20, Polygonum multiflorum 20, calcined oyster 20, dragon bone 25, white peony root 20, Gastrodia elata 15, Uncaria rhynchophylla 20, Angelica sinensis 15, Polygala tenuifolia 15, Acorus tatarinowii 20, Ziziphus jujuba var. spinosa 20, Polygonum multiflorum Thunb. var. caudatum 15, Alpinia oxyphylla 20.

3. The preparation method of a traditional Chinese medicine composition for Lewy body dementia according to claim 1 or 2, characterized in that, It includes the following steps: S1: Take the formula amount of calcined oyster, dragon bone and stir-fried turtle shell, denoted as component A; take the formula amount of Cistanche deserticola, Morinda officinalis, stir-fried turtle shell, Rehmannia glutinosa, Polygonum multiflorum, calcined oyster, dragon bone, white peony root, Gastrodia elata, Uncaria rhynchophylla, Angelica sinensis, Polygala tenuifolia, Acorus tatarinowii, Ziziphus jujuba var. spinosa, Polygonum multiflorum Thunb. var. caudatum, Alpinia oxyphylla, denoted as component B; S2: Add cold water to component A and component B until the water level is 3 - 5 cm above the medicinal materials, and soak for 30 minutes; S3: After boiling the soaked component A until the water boils, continue to simmer over low heat for 30 minutes, then add the pre-soaked component B liquid medicine, add 500 ml of warm water, bring to a boil and then simmer over low heat for another 30 minutes, and filter to obtain the first filtrate; S4: Add 0.9 - 1 L of warm water to the earthenware pot again, continue to bring to a boil over high heat, and simmer over low heat for 30 minutes, and filter to obtain the second filtrate; S5: Combine the first filtrate and the second filtrate, and heat and concentrate to 400 ml to obtain the product.

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