Traditional Chinese medicine compound composition for treating dementia caused by turbid phlegm and clouding orifices as well as preparation method and use method of traditional Chinese medicine compound composition

Abstract

The invention discloses a traditional Chinese medicine compound composition for treating phlegm clouding orifice type dementia and a preparation method and a using method thereof, and the traditional Chinese medicine compound composition is prepared from the following raw materials in parts by mass: 16-23 parts of bamboo juice, 11-17 parts of exocarpium citri rubrum, 6-12 parts of fructus alpiniae oxyphyllae, 12-18 parts of pheretima and 25-32 parts of caulis spatholobi. The traditional Chinese medicine is used for treating the turbid phlegm clouding orifice type dementia patient through a resuscitation inducing and phlegm reducing treatment method, the symptoms of the patient are obviously improved clinically, the compatibility is ingenious, the prescription is simple, only five medicines are adopted, the medicinal materials are easy to obtain and low in price, the requirement of a decoction technology is low, and the curative effect is obvious; the defects that western medicines are large in side effect and prone to generating drug resistance are overcome, and the advantages that traditional Chinese medicines are small in side effect and not prone to generating drug resistance are developed.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine treatment of dementia, and specifically relates to a traditional Chinese medicine compound composition for treating phlegm-turbidity obstructing the orifices type dementia, and a preparation method and a use method thereof. Technical Background

[0002] Dementia is a syndrome characterized by acquired, persistent intellectual disability that affects an individual's memory, thinking, behavior, and ability to live in daily life. Dementia is not a specific disease, but a general term for a group of symptoms. Dementia has become a global health challenge. According to the World Health Organization's 2022 Dementia Research Blueprint, an estimated 55.2 million people are affected worldwide. The prevalence in people over 60 years old varies by region. The incidence of dementia is generally increasing, while it is declining in some high-income countries. By 2030, the estimated number of people with dementia will surge to 78 million. In addition, the global economic burden associated with healthcare, social services, and informal care for people with dementia is expected to exceed $2.8 trillion. This situation will have a profound impact on individuals, families, and society. Alzheimer's disease (AD), the main form of dementia, shows similar epidemiological trends and is an urgent and escalating challenge facing the world.

[0003] The etiology of Alzheimer's disease is complex and diverse, and the exact mechanism of its onset is not fully understood. In addition to the key roles of Aβ and tau proteins, a range of other factors may also contribute to the pathology of AD, which also form the basis of clinical diagnosis and treatment strategies. Biomarkers can identify patients at an early stage, monitor disease progression, and evaluate the effectiveness of drugs. Hypotheses surrounding these pathogenic factors provide potential targets for drug development. However, the development of effective Alzheimer's disease drugs has been challenging. More than a century has passed since Alzheimer's disease was first described in 1906, and significant progress has been made in understanding its pathogenesis, improving diagnosis, and strengthening treatment. Unfortunately, current products still cannot meet the needs of solving the problem of dementia.

[0004] Traditional Chinese medicine has always held the view that "most strange diseases are caused by phlegm". If phlegm invades the head and obscures the clear yang, symptoms such as headache, dizziness, dullness, forgetfulness, coma and madness can be seen. Zhang Jingyue, a doctor in the Ming Dynasty, first proposed the name of dementia and pointed out: "Dementia usually does not have phlegm, but is caused by depression or failure... gradually leading to dementia. Chen Shiduo's "Clinical Records" also said "... phlegm accumulates in the chest and occupies the outside of the heart, making the mind unclear and causing dementia. "It is clear that the generation of phlegm and turbidity is closely related to the damage to the spirit. Phlegm is a sticky and greasy substance. Once it is generated, it likes to flow. It rises and falls with the air and is everywhere. It overflows into the internal organs and reaches the limbs, causing all kinds of diseases. Phlegm and turbidity can disturb the mind and blind the clear orifices, resulting in abnormalities in consciousness and intelligence, manifested as dull consciousness, visual, auditory and language disorders. Stagnation in the meridians can also cause hemiplegia and tremors. "Differential Syndrome Records·Dementia" proposed: "Phlegm accumulates in the brain and entrenches outside the heart, making the spirit unclear and causing dementia." It emphasizes the relationship between phlegm and dementia. "The Secret Records of the Stone Chamber" further pointed out that the severity of dementia is related to the amount of phlegm, that is, "the most phlegm, the deepest dementia." This shows that resolving phlegm and unblocking the meridians is an important overall treatment principle for dementia.

[0005] Previous Chinese patent CN106943525A disclosed a pure Chinese medicine preparation for treating cerebral dementia, which is composed of red ginseng, yellow ginseng, leech, horsefly, angelica, Acanthopanax, Atractylodes, Pseudostellaria, Polygonatum, Rubus, Ligustrum lucidum, Psoralea corylifolia, Cuscuta australis, Lotus stamen, White peony root, Ziziphus jujuba seed, Rhizoma Dioscoreae, Cuscuta australis, Panax notoginseng, Ligusticum chuanxiong, Salvia miltiorrhiza, antler glue, tortoise shell glue, donkey hide gelatin, Cistanche deserticola, Radix Trichosanthis, Indigo, Aloe, Red peony root, Polygonatum odoratum, Lilium, Dragon bone, Liquorice, Hawthorn, Eucommia, Achyranthes bidentata, Mantis, Mole cricket, Eucommia sinensis, Drynaria japonica, frankincense, myrrh, and rhubarb. Chinese patent CN107929666A discloses a Chinese medicine composition for treating dementia, which is composed of Radix Rehmanniae Preparata, Lycium barbarum, Morinda officinalis, Cassia seed, Rhizoma Alismatis, Acorus tatarinowii, Polygala tenuifolia, Salvia miltiorrhiza, Crataegus pinnatifida, Rhizoma Chuanxiong, Fructus Alpiniae Oxyphyllae, Fructus Corni, Curcuma Radix, Radix Pseudostellariae, Fried Ziziphus jujuba seeds, Arisaema cinerea, and Licorice. Chinese patent CN103071143B discloses a Chinese medicine composition for treating Alzheimer's disease, which is composed of Salvia miltiorrhiza, Corydalis yanhusuo, Paeonia lactiflora, Tribulus terrestris, Citron, Rhizoma Chuanxiong, Carthamus tinctorius, Musk, Gleditsia sinensis, Angelica sinensis, Raw Astragalus, Flos Albizziae, Raw Licorice, Ginger, and Jujube according to a certain weight ratio, and can effectively treat Alzheimer's disease. Chinese patent CN102028910B discloses a traditional Chinese medicine preparation for treating Alzheimer's disease and its preparation method, the prescription consists of licorice, silkworm, rhubarb, safflower, mint, cicada shell, turmeric, coptis, gardenia, gastrodia, and borneol.

[0006] The drug formulas of the above four patents all contain multiple drug ingredients. Some of the medicinal materials are expensive and highly volatile when boiled. The decoction requirements are strict and complicated, the application for new drugs is complicated, the drug cost is high, and the stability of the decocted drug ingredients is difficult to grasp. Summary of the invention

[0007] In view of the current lack of simple and effective traditional Chinese medicine treatment for dementia, the present invention provides a traditional Chinese medicine compound composition for treating phlegm-turbidity obstructing the orifices type dementia and its preparation method and use method. The selection of medicinal materials and drug dosage are finally formulated after screening based on clinical experience in the treatment of dementia, and have obtained clear therapeutic effects in clinical trials.

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

[0009] A Chinese medicinal compound composition for treating phlegm-turbidity obstructing dementia comprises the following raw materials in parts by weight: 16-23 parts of bamboo sap, 11-17 parts of tangerine peel, 6-12 parts of Alpinia oxyphylla, 12-18 parts of Pheretima dahurica and 25-32 parts of Millettia reticulata.

[0010] Preferably, the Chinese herbal compound composition for treating phlegm-turbidity type dementia comprises the following raw materials in parts by mass: 20 parts of bamboo sap, 15 parts of tangerine peel, 10 parts of Alpinia oxyphylla, 15 parts of Pheretima dahurica, and 30 parts of Millettia reticulata.

[0011] The present invention also provides a method for preparing a Chinese medicinal compound composition for treating phlegm-turbidity obstructing dementia, comprising the following steps:

[0012] (1) Weigh bamboo juice, tangerine peel, Alpinia oxyphylla, Pheretima dahurica, and Millettia spatholobi according to weight ratio;

[0013] (2) Putting the weighed raw materials in step (1) into water, boiling the raw materials into a medicinal liquid, and obtaining a Chinese herbal compound composition for treating phlegm-turbidity type dementia.

[0014] Preferably, the amount of water added in step (2) is 500 mL.

[0015] Preferably, in step (2), the weighed raw materials are put into 500 mL of water, and the raw materials are decocted to prepare a medicinal liquid, and 200 mL of juice is obtained for each dose of decoction.

[0016] The present invention also provides a method for using the Chinese medicinal compound composition for treating phlegm-turbidity obstructing dementia, and the Chinese medicinal compound composition is used by oral administration.

[0017] Preferably, the oral administration method is to take the Chinese medicine compound composition orally at a warm temperature.

[0018] Preferably, the Chinese medicine compound composition is taken orally twice a day.

[0019] Preferably, the Chinese herbal compound composition is used twice a day, half an hour after breakfast and dinner.

[0020] Preferably, the Chinese medicine compound composition is taken in an amount of 100 mL each time, and a course of treatment is 4 weeks.

[0021] Compared with the prior art, the present invention exhibits the following significant technical advantages, which are not only reflected in the innovative breakthroughs in treating the complex disease of dementia, but also deeply reflect an important direction of the modernization of traditional Chinese medicine:

[0022] (1) From the perspective of drug formulation, many patents for traditional Chinese medicine for the treatment of dementia often contain complex and diverse drug ingredients, and there is no lack of expensive rare medicinal materials in these formulas. These medicinal materials not only increase the economic burden on patients, but also have extremely strict requirements on decoction conditions due to their high volatility during the decoction process. The slightest carelessness may affect the efficacy of the medicine, making the entire treatment process cumbersome and costly. More importantly, the stability of the drug ingredients in these complex formulas is difficult to accurately control, further increasing the difficulty and uncertainty of new drug applications. In contrast, the present invention, through in-depth research and clinical practice, creatively proposed a method of resolving phlegm, unblocking the meridians, and awakening the mind, and accordingly formulated a prescription for awakening the mind and resolving phlegm, specifically for the treatment of patients with phlegm-turbidity obstructing the meridians type dementia. The compatibility of this prescription is exquisite and consists of only 5 medicinal materials. Not only are the medicinal materials widely available and inexpensive, but the decoction process is simple and easy, and no special technical requirements are required. More importantly, the prescription has significantly improved the patient's symptoms in clinical practice, and its efficacy is significant and stable. It not only effectively avoids the common problems of Western medicine, such as large side effects and easy drug resistance, but also fully develops the unique advantages of Chinese medicine, such as small side effects and long-term treatment that is not easy to produce drug resistance. This breakthrough has undoubtedly brought new hope and options for the treatment of dementia patients.

[0023] (2) The prescription for invigorating the mind and resolving phlegm of the present invention does not sacrifice its therapeutic effect while simplifying the formula. On the contrary, through precise compatibility and scientific verification, the prescription has demonstrated remarkable clinical efficacy. This achievement not only reflects the ancient wisdom of traditional Chinese medicine that "simple prescriptions can cure serious diseases", but also highlights the important role of modern scientific and technological means in the research and development of traditional Chinese medicine. Compared with previous complex and expensive treatment plans, the present invention is undoubtedly closer to the actual needs of patients, reduces treatment costs, and improves the accessibility and sustainability of treatment. At the same time, by overcoming the side effects and drug resistance problems of Western medicine, the present invention further consolidates the unique position of traditional Chinese medicine in the field of chronic disease treatment, and lays a solid foundation for the modernization and international promotion of traditional Chinese medicine.

[0024] (3) The Chinese medicine compound composition of the present invention has accumulated a large amount of data and experience in clinical applications. After long-term observation and practice, the prescription not only has a clear therapeutic effect, but also has no toxic and side effects. This safety record undoubtedly provides a strong guarantee for its wide application in the future. In the context of the growing demand for the treatment of chronic diseases such as dementia worldwide, the Chinese medicine compound composition of the present invention undoubtedly has huge market potential and social value. It can not only provide patients with a safer, more effective and economical treatment plan, but also promote the further development and prosperity of traditional Chinese medicine. Therefore, we have reason to believe that the Chinese medicine compound composition of the present invention will occupy a place in the future medical market and make greater contributions to human health. DETAILED DESCRIPTION

[0025] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the preferred examples. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0026] In an embodiment of the present invention, a Chinese herbal compound composition for treating phlegm-turbidity type dementia comprises the following raw materials in parts by weight: 16-23 parts of bamboo sap, 11-17 parts of tangerine peel, 6-12 parts of Alpinia oxyphylla, 12-18 parts of Pheretima chinensis, and 25-32 parts of Millettia reticulata.

[0027] After weighing the above raw materials, add 500mL of clean water. After the raw materials are made into liquid medicine, take 200mL and take it warm twice a day, morning and evening, after meals.

[0028] Technical principle of the present invention:

[0029] The sources and effects of the raw materials of the present invention are all derived from the Chinese Pharmacopoeia:

[0030] Bamboo juice: Also known as bamboo juice, light bamboo juice, bamboo oil. This product is the liquid naturally leached from the fresh stems of Phyllostachys glauca McClure, Phyllostachys nuda McClure and several other plants of the same genus after heating. Nature and flavor and meridians: sweet, cold, heart and stomach meridians. Efficacy and indications: clearing away heat and resolving phlegm, calming the nerves and benefiting the orifices. Used for aphasia caused by stroke, cough with phlegm, thirst, depression, convulsions, and epilepsy.

[0031] Citrus peel: Also known as Yunpi, Yunhong. This product is the outer peel of the dried mature fruit of the Rutaceae plant Citrus reticulata Blanco and its cultivated varieties. Nature and flavor and meridians: pungent, bitter, warm, and enter the lung meridian. Efficacy and indications: dispel cold, dry dampness, promote qi, and eliminate phlegm. It is used for wind-cold cough, itchy throat, food stagnation and alcohol damage, nausea and stuffiness.

[0032] Alpinia oxyphylla Miq.: Also known as Alpinia oxyphylla and Zhaizizi. This product is the dried mature fruit of the ginger plant Alpinia oxyphylla Miq. Nature and flavor and meridians: pungent, warm, spleen and kidney meridians. Efficacy and indications: warms the spleen and stops diarrhea, controls saliva, warms the kidney, consolidates semen and reduces urine. It is used for diarrhea caused by spleen cold, cold pain in the abdomen, excessive salivation, enuresis due to kidney deficiency, frequent urination, and turbid spermatorrhea.

[0033] Guangdilong: Also known as earthworm, earthworm, earthworm, hillworm, winding snake, Yinwu, attached earthworm, cold earthworm, curved snake, curved snake, earth dragon, earthworm, earthworm, insect snake. It is an animal of the family Lumbricidae. Nature and flavor and meridians: salty, cold, it enters the liver, spleen, and bladder meridians. Efficacy and indications: clearing away heat and calming the nerves, unblocking the meridians, relieving asthma, and diuresis. It is used for high fever and coma, epilepsy and convulsions, joint pain and limb numbness, hemiplegia, lung heat and cough, edema and oliguria.

[0034] Millettia spatholobus: Also known as Blood Wind, Blood Teng, Blood Wind Teng. This product is the dried vine stem of the legume plant Spa tholobus suberectus Dunn. Nature and flavor and meridians: bitter, sweet, warm, liver and kidney meridians. Efficacy and indications: promote blood circulation and replenish blood, regulate menstruation and relieve pain, relax muscles and activate collaterals. Used for irregular menstruation, dysmenorrhea, amenorrhea, rheumatic arthralgia, numbness and paralysis, and blood deficiency and chlorosis.

[0035] The invention is a Chinese medicine compound composition specially used for treating phlegm-turbidity obstructing dementia. The carefully selected raw materials and the strictly controlled dosage ratio are the key to ensure that the prescription exerts the best therapeutic effect. The compound composition specifically comprises the following raw materials by weight: 16-23 parts of bamboo sap, 11-17 parts of tangerine peel, 6-12 parts of Alpinia oxyphylla, 12-18 parts of Pheretima dahurica, and 25-32 parts of Millettia reticulata. The dosage selection of each raw material is based on its unique pharmacological action and its synergistic effect in the prescription, which embodies the compatibility principle of "monarch, minister, assistant and messenger" in traditional Chinese medicine.

[0036] As the "main drug" in the prescription, bamboo juice is cold in nature, sweet and bitter in taste, and enters the heart, liver, and lung meridians. Its main effects are clearing heat and resolving phlegm, opening the orifices and refreshing the mind. The precise control of its dosage (16-23 parts) can ensure sufficient heat-clearing and phlegm-resolving power without being too cold to damage the vital energy. It is the core of the prescription in clearing heat and resolving phlegm, opening the orifices and refreshing the mind. The appropriate use of bamboo juice ensures that phlegm and turbidity can be effectively removed, creating conditions for the subsequent unblocking of meridians and refreshing the mind.

[0037] Tangerine peel, as a "minister medicine", is used together with bamboo juice to enhance the effect of resolving phlegm. Tangerine peel resolves phlegm, regulates qi and strengthens the spleen. The setting of its dosage range (11-17 parts) is intended to enhance the power of resolving phlegm while taking into account the spleen and qi, avoiding the root cause of phlegm and turbidity. The synergistic effect of tangerine peel and bamboo juice not only strengthens the effect of resolving phlegm, but also promotes the recovery of spleen and stomach function, allowing the normal distribution of body fluids and reducing the formation of phlegm and turbidity.

[0038] As an adjuvant, the effect of Alpinia oxyphyllae (6-12 servings) in warming the spleen and kidney and consolidating the essence is crucial for improving the spleen and kidney function of patients with dementia. The dosage of Alpinia oxyphyllae (6-12 servings) is just right, which can not only warm the fire of the gate of life and promote the biochemical transformation of the spleen and earth, but also strengthen the spleen and kidney, so that the body fluid can be transported normally and the phlegm can be sharply reduced. This "tonifying" method complements the "unblocking" method of bamboo juice and tangerine peel, and together they constitute the therapeutic core of the prescription.

[0039] As "helper drugs", Dilong and Millettia reticulata play the role of promoting blood circulation and improving blood circulation in the prescription. The dosage of Dilong (12-18 parts) ensures that its anticoagulant, antithrombotic and antioxidant pharmacological effects can be fully exerted, and avoids the risk of bleeding due to excessive dosage. Millettia reticulata (25-32 parts) is rich in chemical components such as flavonoids and phenylpropanoids, and has the pharmacological effects of regulating the blood system and anti-oxidation. The control of its dosage is aimed at ensuring the improvement of blood circulation and promoting the recovery of brain function.

[0040] In summary, the precise control of the amount of each raw material in the Chinese medicine compound composition of the present invention is a key factor in producing synergistic effects and ensuring therapeutic effects. The amount of each raw material is carefully considered, aiming to not only exert their own unique pharmacological effects, but also achieve the therapeutic purposes of resolving phlegm, unblocking meridians, and awakening the mind through mutual synergy. This compound composition with exquisite compatibility, simple prescription, easy access to medicinal materials and low price not only has low decoction technology requirements, but also has significant, accurate and stable therapeutic effects, providing an effective Chinese medicine treatment method for patients with phlegm-turbidity obstructing the mind type dementia.

[0041] 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.

[0042] 1. Examples and Comparative Examples

[0043] Example 1

[0044] A traditional Chinese medicine compound composition for treating phlegm-turbidity obstructing dementia comprises the following raw materials: 16g of bamboo sap, 12g of tangerine peel, 7g of Alpinia oxyphylla, 12g of Pheretima dahurica and 25g of Millettia reticulata.

[0045] Preparation method: After adding 500mL of clean water, after the raw materials are made into liquid medicine, take 200mL and take it twice a day, morning and evening, half an hour after meals, after warming.

[0046] Directions for use: Oral administration, 100 mL twice a day, morning and evening, 4 weeks as a course of treatment.

[0047] Example 2

[0048] A Chinese medicinal compound composition for treating phlegm-turbidity obstructing dementia comprises the following raw materials: 20g of bamboo sap, 15g of tangerine peel, 10g of Alpinia oxyphylla, 15g of Pheretima dahurica and 30g of Millettia reticulata.

[0049] Preparation method: After adding 500mL of clean water, after the raw materials are made into liquid medicine, take 200mL and take it twice a day, morning and evening, half an hour after meals, after warming.

[0050] Directions for use: Oral administration, 100 mL twice a day, morning and evening, 4 weeks as a course of treatment.

[0051] Example 3

[0052] A Chinese medicinal compound composition for treating phlegm-turbidity obstructing dementia comprises the following raw materials: 18g of bamboo sap, 13g of tangerine peel, 8g of Alpinia oxyphylla, 14g of Pheretima dahurica and 27g of Millettia reticulata.

[0053] Preparation method: After adding 500mL of clean water, after the raw materials are made into liquid medicine, take 200mL and take it twice a day, morning and evening, half an hour after meals, after warming.

[0054] Directions for use: Oral administration, 100 mL twice a day, morning and evening, 4 weeks as a course of treatment.

[0055] Example 4

[0056] A Chinese medicinal compound composition for treating phlegm-turbidity obstructing dementia comprises the following raw materials: 23g of bamboo sap, 16g of tangerine peel, 11g of Alpinia oxyphylla, 18g of Pheretima dahurica and 31g of Millettia reticulata.

[0057] Preparation method: After adding 500mL of clean water, after the raw materials are made into liquid medicine, take 200mL and take it twice a day, morning and evening, half an hour after meals, after warming.

[0058] Directions for use: Oral administration, 100 mL twice a day, morning and evening, 4 weeks as a course of treatment.

[0059] Comparative Example 1

[0060] A Chinese medicinal compound composition for treating phlegm-turbidity obstructing dementia comprises the following raw materials: 8g of bamboo sap, 5g of tangerine peel, 3g of Alpinia oxyphylla, 25g of Pheretima dahurica and 50g of Millettia reticulata.

[0061] Preparation method: After adding 500mL of clean water, after the raw materials are made into liquid medicine, take 200mL and take it twice a day, morning and evening, half an hour after meals, after warming.

[0062] Directions for use: Oral administration, 100 mL twice a day, morning and evening, 4 weeks as a course of treatment.

[0063] Comparative Example 2

[0064] A Chinese medicinal compound composition for treating phlegm-turbidity obstructing dementia comprises the following raw materials: 32g of bamboo sap, 5g of tangerine peel, 15g of Alpinia oxyphylla, 6g of Pheretima dahurica and 12g of Millettia reticulata.

[0065] Preparation method: After adding 500mL of clean water, after the raw materials are made into liquid medicine, take 200mL and take it twice a day, morning and evening, half an hour after meals, after warming.

[0066] Directions for use: Oral administration, 100 mL twice a day, morning and evening, 4 weeks as a course of treatment.

[0067] Comparative Example 3

[0068] The Chinese medicine composition was prepared according to Example 2 in the Chinese patent document (Announcement No.: CN103071143B).

[0069] How to use: Take orally, twice a day, morning and evening, half an hour after meals, warm up and take, 100mL each time, 4 weeks as a course of treatment.

[0070] 2. Application Examples

[0071] Wang, male, 72 years old, from Nanning, has had memory loss in the past six months, and has recently become lost and has unclear speech. He is now seeking treatment with traditional Chinese medicine. His current symptoms are: forgetfulness, heaviness, lack of energy, decreased language logic, decreased orientation, greasy white tongue coating, and slippery pulse. A plain scan of the head CT scan showed brain atrophy. After one course of treatment with the medication of Example 2 according to the present invention, the patient's forgetfulness was alleviated, and his language logic ability was significantly improved compared with before.

[0072] Wu Moumou, female, 68 years old, from Baise City, had repeated dizziness, dull expression, and slow reaction for half a year. The clinical diagnosis was AD. The patient refused medication treatment. Now the slow reaction worsens, so she came to the clinic. The current symptoms are: memory loss, repeated speech, decreased judgment and problem-solving ability, pale tongue, white and greasy fur, and a stringy and slippery pulse. After one course of treatment with Example 2 according to the present invention, the patient's reaction ability was significantly improved compared with before, and the speech was no longer repeated.

[0073] Wang, female, 77 years old, from Hechi City, the patient had decreased calculation ability and memory 2 weeks ago, often forgetting familiar names, first came for diagnosis, symptoms: decreased calculation ability, orientation, forgetfulness, chest tightness, nausea, emotional indifference, loss of appetite, loose stools, white greasy tongue coating, slippery pulse. After one course of treatment with Example 2 according to the present invention, the patient recovered and was followed up for half a year without recurrence.

[0074] 3. Clinical Research

[0075] 1. Medical records

[0076] 1.1 Number of people selected

[0077] A total of 70 patients with dementia were selected.

[0078] 1.2 Diagnostic criteria

[0079] 1.2.1 Diagnostic criteria for Alzheimer's disease (AD)

[0080] The diagnostic criteria for Alzheimer's disease include: impaired daily work and general activities; significantly reduced ability to live; abnormal personality and behavior; cannot be explained by other mental illnesses such as delirium and depression; insidious onset and gradual worsening of the disease; impairment of two or more cognitive functions such as language ability and comprehension ability; and dementia symptoms not caused by other diseases.

[0081] 1.2.2 Diagnostic criteria for phlegm-induced dementia:

[0082] Refer to the syndrome diagnostic criteria of "Guidelines for Clinical Research on Mild Cognitive Impairment (Draft)" by Tian Jinzhou et al. in 2008.

[0083] (1) Expression is indifferent or few words (2 points)

[0084] (2) Dull expression or slow response (3 points)

[0085] (3) Sleepiness (5 points)

[0086] (4) Excessive saliva in the mouth (2 points)

[0087] (5) Coughing up or vomiting sputum (3 points)

[0088] (6) Excessive and sticky phlegm (4 points)

[0089] (7) Snoring, phlegm, and sticky saliva in the mouth (5 points)

[0090] (8) Dizziness and heaviness (2 points)

[0091] (9) Obese (2 points)

[0092] (10) The face is dirty and filthy (3 points)

[0093] (11) Greasy tongue coating (2 points)

[0094] (12) Greasy tongue coating (4 points)

[0095] (13) Tongue coating is rotten and foul (6 points)

[0096] (14) Enlarged tongue (3 points)

[0097] (15) Tongue is fat with many teeth marks (5 points)

[0098] (16) Slippery pulse (2 points)

[0099] The sum of the scores of each symptom is the total score of the syndrome, and the highest score is 30. >7 points is considered a diagnosis of the syndrome; the severity is graded as follows: 7-14 points are mild, 15-22 points are moderate, and 23-30 points are severe.

[0100] 1.3 Case inclusion criteria

[0101] (1) Meet the diagnostic criteria of dementia in both traditional Chinese and Western medicine;

[0102] (2) aged ≥60 years;

[0103] (3) Not taking Chinese patent medicine, decoctions, or related Western medicine for the treatment of dementia within 2 weeks;

[0104] (4) With the approval of the hospital ethics committee, family members of the enrolled patients must sign informed consent.

[0105] 1.4 Case Exclusion Criteria

[0106] Except for those who have any of the following conditions:

[0107] Patients with dementia caused by other factors, such as vascular dementia; patients with severe heart, liver, and kidney dysfunction; patients with malignant tumors; patients with schizophrenia and other mental illnesses; patients who are allergic to the drugs used in this study; patients who have received anti-dementia or psychiatric drug treatment in the past 3 months.

[0108] 1.5 Rejection and shedding criteria

[0109] (1) Cases that do not meet the inclusion criteria or are mistakenly included;

[0110] (2) The subject's condition has not been controlled to the expected level within a period of time;

[0111] (3) Those that affect the determination of efficacy, such as failure to use the drug as prescribed or incomplete clinical data;

[0112] (4) The subject voluntarily requests to withdraw from the trial for various reasons;

[0113] (5) Patients with other serious complications during the study;

[0114] (6) Taking other drugs during the study that may affect the efficacy evaluation.

[0115] 2. Methods

[0116] 2.1 Treatment methods

[0117] 70 patients with vertigo were randomly divided into 2 groups, 35 in each group, using envelope concealment random grouping method. 70 sealed envelopes with information of treatment group or control group were randomly shuffled by personnel outside the research group, and the patients were grouped according to the envelope information randomly drawn by the patients. The control group was given oral ganlut sodium capsules, and the treatment group was given oral decoction of Huatan Kaiqiao Fang. There was no significant difference in the general data of the two groups of patients, and the two groups were comparable.

[0118] Control group: Oral administration of sodium mannitol capsules (Shanghai Green Valley Pharmaceutical Co., Ltd.), 450 mg each time, twice a day, morning and evening, for 4 weeks.

[0119] Treatment group: oral administration of the phlegm-removing and orifice-opening prescription, the prescription of Example 2: 20g of bamboo sap, 15g of tangerine peel, 10g of Alpinia oxyphylla, 15g of Pheretima dahurica, 30g of Millettia spatholobi. After being put into 500mL of clear water, the raw materials were decocted to prepare a medicinal liquid, 200mL of juice was decocted for each dose, 100mL was taken each time, and it was taken after warming 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 (ADAS-cog) was used for scoring

[0123] 2.2.2 Intelligent Assessment

[0124] The modified Hasegawa brief mental sizing scale (HDS-R) was used for scoring

[0125] 2.2.3 Assessment of Dementia

[0126] Clinical Dementia Rating (CDR) was used to score

[0127] 2.2.4 Efficacy evaluation

[0128] Developed with reference to the "Guidelines for the Diagnosis and Treatment of Alzheimer's Disease (2020 Edition)". Significantly effective: The patient's clinical symptoms disappeared, his mental state was good, he could communicate normally, his daily living ability was restored, and the score of the Mini-Mental State Examination (MMSE) of the Simple Intelligence Scale increased by more than 50%. Effective: The patient's clinical symptoms were relieved, his mental state was general, he could communicate, but with certain obstacles, his daily living ability was restored, and the MMSE score increased by 25-50%. Ineffective: The patient's clinical symptoms were not relieved, his mental state was not improved, his communication and living ability were severely impaired, and the MMSE score increased by less than 25%.

[0129] Effective rate = (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 Chinese patent medicines for the treatment of dementia. Symptomatic medications can be used for other complications without affecting the efficacy evaluation of the study drug. 。

[0132] 2.4 Data Processing

[0133] SPSS 26.0 statistical software was used to analyze all data, and the measurement data were expressed as mean ± standard deviation. The two groups of data were tested for normal distribution. If they were in accordance with normal distribution, the independent sample t test was used. If they were not in accordance with normal distribution, the non-parametric test was used. The count data were expressed as frequency and percentage, and the chi-square test and rank sum test were used. P < 0.05 indicated that the difference was significant. 。

[0134] 3. Results

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

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

[0137] Table 1 Comparison of total scores of cognitive assessment between the two groups before and after treatment ( point)

[0138]

[0139]

[0140] 3.2 Comparison of HDS-R scores between the two groups before and after treatment

[0141] There was no statistical difference in the HDS-R scores between the two groups before treatment. After treatment, the HDS-R scores in the treatment group were significantly higher than those in the control group (P < 0.05), as shown in Table 2.

[0142] Table 2 Comparison of HDS-R scores between the two groups before and after treatment ( point)

[0143]

[0144] 3.3 Comparison of CDR ratings between the two groups before and after treatment

[0145] According to the results of the rank sum test, the CDR scale scores of the treatment group and the moderate and severe dementia in the treatment group were significantly lower than those in the control group (P < 0.05), as shown in Table 3 for details.

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

[0147]

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

[0149] As shown in Table 4, the effective rate of the treatment group was as high as 94.29%, which was significantly higher than 77.14% of the control group (P<0.05). The number of cured patients and the number of patients with markedly effective results were significantly higher than those of the control group.

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

[0151]

[0152]

[0153] 4. Security

[0154] 35 patients in the treatment group took the Chinese herbal compound composition for treating phlegm-turbidity and obstruction type dementia of the present invention, and the patients had high compliance. Biochemical examinations showed no abnormal changes in routine blood tests and routine urine and stool tests, no adverse effects on liver and kidney functions, and no obvious toxic and side effects. The composition was safe and reliable to take and had significant therapeutic effects, which further illustrates that the Chinese herbal compound composition for treating phlegm-turbidity and obstruction type dementia of the present invention has good market application prospects.

[0155] IV. Comparative Test of Treatment Effects of Examples and Comparative Examples

[0156] 245 patients with vertigo were randomly divided into 7 groups, 35 in each group, and the grouping was carried out by envelope concealment random grouping method. 245 sealed envelopes with written information were randomly shuffled by personnel outside the research group, and the 7 groups were grouped according to the envelope information randomly drawn by the patients. The 7 groups took the Chinese medicine compound composition of Examples 1-4 and the Chinese medicine composition of Comparative Examples 1-3 respectively. There was no significant difference in the general data statistics of the 7 groups of patients, and the comparison was comparable. The clinical research method was similar to the above-mentioned clinical research method, and the results of the efficacy evaluation after treatment were shown in Table 5 below.

[0157] Table 57 Results of efficacy evaluation after treatment

[0158]

[0159] Through in-depth analysis of the detailed data in Table 5, the present invention can draw the following important conclusions:

[0160] (1) The excellent results of the present invention have been fully verified, and its effective rate is as high as 88.57% or more. This data not only demonstrates the remarkable therapeutic effect of the present invention, but also reflects its leading position among similar inventions. It is particularly worth mentioning that in Example 2, we adopted an optimal formula, which not only achieved the highest effective rate, but also performed well in practical applications and won wide acclaim. This achievement undoubtedly adds a strong touch to the invention of the present invention.

[0161] (2) Further comparing the data of Comparative Examples 1 and 2, we found a remarkable phenomenon: when the dosage ratio of Bamboo Sap, Tangerine Peel, Alpinia Alpiniae Oxyphyllae, Pheretima Lucidum, and Millettia Spatholobi was not within the key range of (16-23): (11-17): (6-12): (12-18): (25-32), the effective rate showed a significant decline. Specifically, there is a significant gap between the effective rate data of Comparative Examples 1 and 2 and the present invention (Examples 1-4). This discovery not only verifies the scientificity and rationality of the raw material dosage ratio in the present invention, but also highlights the importance of controlling these raw material dosage ratios. It can be said that the dosage of raw materials is extremely critical, and a slight deviation may lead to a significant decline in efficacy. This discovery not only provides strong data support for the present invention, but also points out the direction for subsequent research and development work.

[0162] (3) Compared with the prior art, the advantages of the present invention are more obvious. As can be seen from Table 5, the effective rate of the present invention (Examples 1-4) is significantly higher than that of the prior art (Comparative Example 3), which is at least increased by 10.71%. This data not only reflects the significant progress in the efficacy of the present invention, but also highlights its technological advancement and innovation. In addition, the prescription of the present invention is exquisitely compatible, containing only 5 medicinal materials, and these medicinal materials are easy to obtain and inexpensive. Compared with the problems in the prior art that the drug formula contains multiple drug ingredients, some medicinal materials are expensive, and the preparation cost is high, the present invention undoubtedly has significant advantages. This discovery not only adds more highlights and advantages to the present invention, but also provides a strong guarantee for its promotion and application in the market.

[0163] In summary, the present invention not only has excellent curative effect and significant progress, but also shows unique advantages in the control of raw material dosage ratio, exquisite prescription compatibility, easy access to medicinal materials and low price, etc. These advantages have not only won wide recognition and praise for the present invention, but also laid a solid foundation for its future development and application.

[0164] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A Chinese medicinal compound composition for treating phlegm-turbidity type dementia, characterized in that: The invention comprises the following raw materials in parts by weight: 16-23 parts of bamboo sap, 11-17 parts of orange peel, 6-12 parts of Alpinia oxyphylla kernel, 12-18 parts of Pheretima dahurica and 25-32 parts of Millettia reticulata.

2. The Chinese medicinal compound composition for treating phlegm-turbidity type dementia according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 20 parts of bamboo juice, 15 parts of orange peel, 10 parts of Alpinia oxyphylla, 15 parts of Pheretima dahurica and 30 parts of Millettia reticulata.

3. A method for preparing a Chinese medicinal compound composition for treating phlegm-turbidity type dementia according to claim 1 or 2, characterized in that: The following steps are involved: (1) Weigh bamboo juice, tangerine peel, Alpinia oxyphylla, Pheretima dahurica, and Millettia spatholobi according to weight ratio; (2) Putting the weighed raw materials in step (1) into water, boiling the raw materials into a medicinal solution, and obtaining a Chinese herbal compound composition for treating phlegm-turbidity type dementia.

4. The method for preparing the Chinese medicinal compound composition for treating phlegm-turbidity type dementia according to claim 3, characterized in that: The amount of water added in step (2) is 500 mL.

5. The method for preparing the Chinese medicinal compound composition for treating phlegm-turbidity type dementia according to claim 3, characterized in that: In step (2), the weighed raw materials are added into 500 mL of water, and the raw materials are decocted to prepare a medicinal liquid, and 200 mL of juice is obtained for each dose of decoction.

6. A method for using the Chinese medicinal compound composition for treating phlegm-turbidity type dementia prepared according to the method according to any one of claims 3 to 5, characterized in that: The Chinese medicine compound composition is used orally.

7. The method for using the Chinese medicinal compound composition for treating phlegm-turbidity type dementia according to claim 6, characterized in that: The internal administration method is to take the Chinese medicine compound composition internally in a warm manner.

8. The method for using the Chinese medicinal compound composition for treating phlegm-turbidity type dementia according to claim 7, characterized in that: The Chinese medicine compound composition is taken orally twice a day.

9. The method for using the Chinese medicinal compound composition for treating phlegm-turbidity type dementia according to claim 8, characterized in that: The time for using the Chinese herbal compound composition twice a day is half an hour after breakfast and dinner.

10. The method for using the Chinese medicinal compound composition for treating phlegm-turbidity type dementia according to claim 9, characterized in that: The Chinese medicine compound composition is taken in 100 mL each time, and 4 weeks constitutes a course of treatment.

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