Traditional Chinese medicine preparation for preventing and treating insomnia and depression and production method thereof

Abstract

The invention provides a traditional Chinese medicine preparation for preventing and treating insomnia and depression and a production method thereof, and belongs to the field of traditional Chinese medicine preparations, and the traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine raw materials in parts by weight: 3-5 parts of gastrodia elata, 5-10 parts of spina date seed, 5-10 parts of codonopsis pilosula, 5-10 parts of bighead atractylodes rhizome, 5-10 parts of poria cocos, 5-10 parts of radix rehmanniae and 5-10 parts of hawthorn. According to the traditional Chinese medicine, all the medicines are matched with one another, complement each other, nourish blood, tranquilize nerves, calm liver wind, activate blood, cool blood, induce diuresis, remove dampness, tonify spleen, treat both symptoms and root causes, and protect the important organ function of the body.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine preparation for preventing and treating insomnia and depression and a production method thereof. BACKGROUND

[0002] Research progress of clinical manifestations and mechanisms of depression, Depression is a common mental illness in clinical, mainly a syndrome with depressive mood as the main performance, the main clinical manifestations of patients are low life motivation, persistent fatigue, lack of interest, low mood, often accompanied by early awakening, general malaise, weight loss, insomnia, restlessness, which is harmful to the body.

[0003] Differential diagnosis and clinical diagnosis and treatment of depression in the elderly and cognitive impairment, The SDS score of GD patients was significantly higher than that of the national norm (P<0.01), the incidence of depression was 19.97%, mainly mild and moderate, and the incidence was related to education level, negative life events and accompanying somatic diseases. The most common symptom is depressive mood, followed by early awakening, work and interest, sleep not deep, general symptoms, and decreased ability. Conclusion: The incidence of GD is high, with unique clinical manifestations and TCM syndrome characteristics, which should be identified in clinical practice.

[0004] Research progress of traditional Chinese medicine in the treatment of senile depression, Senile depression is a depressive disorder that occurs in people over the age of 55, and a more accurate definition is that the first onset of the disease occurs at the age of 55 or older. Epidemiological surveys have shown that the annual prevalence of senile depression is about 5%, and most of them are accompanied by cognitive impairment, as well as dementia, coronary heart disease, hypertension, diabetes, etc. Compared with young and middle-aged patients, the physical condition of elderly patients has declined, the mechanism is complex, the etiology is more complex, and the outcome is more serious. In addition, social factors are complex, and the aging of the population is increasing, which has led to an increasing trend in the incidence of senile depression. Studies have shown that more than half of senile depression patients have cognitive impairment, which can exacerbate the condition of depression, and the incidence of depression in patients with cognitive impairment is as high as about 44%, both of which interact with each other. Senile depression and cognitive impairment in the elderly belong to the nervous and mental system depression of the elderly.

[0005] The paper aims to explore the mechanism and clinical research progress of Chaihu in the prevention and treatment of MDD by expounding the TCM understanding of MDD, the main active components of Chaihu, the pharmacological mechanism and clinical application of classic compound and Chinese patent medicine in the prevention and treatment of MDD. The core pathogenesis of MDD is liver depression and qi stagnation. The main active components of Chaihu include Chaihu saponin A, Chaihu saponin D, kaempferol, quercetin, baicalin, volatile oil, etc., which have many effects such as anti-inflammatory, antioxidant, inhibition of cell apoptosis, regulation of neurotransmitters, etc. The classic compound (Chaihu Shugan Powder, Sini Powder, Chaihu Jia Longgu Muyu Decoction, etc.) and Chinese patent medicine (Chaigui Granules, Jieyu Anshen Granules, Xiaoyao Pills, Shugan Granules, etc.) have the advantages of multi-pathway and multi-target in the treatment of MDD. The classic compound can be combined with other prescriptions or other therapies such as acupuncture to treat more complex depressive manifestations combined with other symptoms in clinic.

[0006] The paper aims to explore the mechanism and clinical research progress of Chaihu in the prevention and treatment of MDD by expounding the TCM understanding of MDD, the main active components of Chaihu, the pharmacological mechanism and clinical application of classic compound and Chinese patent medicine in the prevention and treatment of MDD. The core pathogenesis of MDD is liver depression and qi stagnation. The main active components of Chaihu include Chaihu saponin A, Chaihu saponin D, kaempferol, quercetin, baicalin, volatile oil, etc., which have many effects such as anti-inflammatory, antioxidant, inhibition of cell apoptosis, regulation of neurotransmitters, etc. The classic compound (Chaihu Shugan Powder, Sini Powder, Chaihu Jia Longgu Muyu Decoction, etc.) and Chinese patent medicine (Chaigui Granules, Jieyu Anshen Granules, Xiaoyao Pills, Shugan Granules, etc.) have the advantages of multi-pathway and multi-target in the treatment of MDD. The classic compound can be combined with other prescriptions or other therapies such as acupuncture to treat more complex depressive manifestations combined with other symptoms in clinic.

[0007] The paper aims to explore the mechanism and clinical research progress of Chaihu in the prevention and treatment of MDD by expounding the TCM understanding of MDD, the main active components of Chaihu, the pharmacological mechanism and clinical application of classic compound and Chinese patent medicine in the prevention and treatment of MDD. The core pathogenesis of MDD is liver depression and qi stagnation. The main active components of Chaihu include Chaihu saponin A, Chaihu saponin D, kaempferol, quercetin, baicalin, volatile oil, etc., which have many effects such as anti-inflammatory, antioxidant, inhibition of cell apoptosis, regulation of neurotransmitters, etc. The classic compound (Chaihu Shugan Powder, Sini Powder, Chaihu Jia Longgu Muyu Decoction, etc.) and Chinese patent medicine (Chaigui Granules, Jieyu Anshen Granules, Xiaoyao Pills, Shugan Granules, etc.) have the advantages of multi-pathway and multi-target in the treatment of MDD. The classic compound can be combined with other prescriptions or other therapies such as acupuncture to treat more complex depressive manifestations combined with other symptoms in clinic.

[0008] Depression is a common disease in psychiatry, which can cause serious harm to human mental health. It is necessary to pay attention to and strengthen the treatment of depression to ensure treatment effect, effectively reduce the patient's depression, improve clinical symptoms, reduce the impact of the disease on daily life, and improve the quality of life. Chinese medicine such as Schisandra chinensis, Chuanxiong, Coptis, bath towel and bergamot has good effect in the treatment of depression, which can play the role of soothing the mind, soothing the liver and regulating qi, promoting blood circulation, removing blood stasis, removing heat and resolving toxins, and improving related clinical symptoms caused by depression. The curative effect is better. Therefore, this paper analyzes the overview of depression, the conventional treatment method and the deficiency of depression, the pathogenesis of depression, the advantages of Chinese medicine in treating depression, and the research progress of Chinese medicine in preventing and treating depression, and discusses the effect of different Chinese medicine in treating depression, hoping to provide reference for the treatment of depression.

[0009] The latest progress of the research on the treatment of depression is disclosed. Depression is a very common mental disease in clinical practice, and its incidence has been rising in recent years. The treatment of this disease is very difficult. The drugs currently used for the treatment of depression mainly include: tricyclic antidepressants, monoamine oxidase inhibitors, 5-HT and NA reuptake inhibitors (SNRIs), NA and NA reuptake inhibitors (NDRIs), and newly discovered new target drugs such as neurosteroids, indoleamine 2,3-dioxygenase and hormone drugs.

[0010] Clinical manifestations and treatment research progress of patients with anxiety depression are disclosed. Patients with anxiety depression (i.e. patients with depressive symptoms) account for more than half of all patients with depression, and the disease is more serious, chronic and has a high risk of suicide, accompanied by obvious sleep disorders and suicidal behavior, and the treatment is difficult. The use of new antidepressants can significantly relieve the patient's condition, but the initial dose of the drug should be low, and the dose should be increased slowly to avoid causing anxiety symptoms to worsen. Combination of anti-anxiety drugs, new antipsychotic drugs, psychological treatment, etc. can improve the clinical cure rate of patients with anxiety depression. Therefore, a Chinese medicine preparation for preventing and treating insomnia and depression and its production method need to be designed. SUMMARY

[0011] The purpose of the present application is to overcome the shortcomings of existing depression, and to provide a Chinese medicine preparation for preventing and treating depression, its production method and use, which has good curative effect, low cost and no side effects.

[0012] The present application is a method newly invented on the basis of inhibiting acetylcholinesterase (AchE) activity and inhibiting beta-secretase activity, which provides a Chinese medicine preparation for treating depression and insomnia and its production method.

[0013] It is made of Gastrodia elata, Jujube seed, Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Rehmannia glutinosa, Crataegus pinnatifida etc. according to the combination of TCM theory and modern scientific experiment. Its production method is to use the above-mentioned drugs to make capsule, oral liquid, granules and tablets by modern pharmaceutical production process such as water extraction and alcohol precipitation. The medicine has the activities of inhibiting acetylcholinesterase (AchE) and beta secretase, and is suitable for treating insomnia and depression.

[0014] In order to achieve the above-mentioned purpose, the technical scheme adopted by the present application is as follows:

[0015] A traditional Chinese medicine preparation for preventing and treating insomnia and depression is made of the following traditional Chinese medicine raw materials by weight: Gastrodia elata 3-5 parts, Jujube seed 5-10 parts, Codonopsis pilosula 5-10 parts, Atractylodes macrocephala 5-10 parts, Poria cocos 5-10 parts, Rehmannia glutinosa 5-10 parts, and Crataegus pinnatifida 5-10 parts.

[0016] Further, the traditional Chinese medicine preparation is used for treating headache, insomnia and depression.

[0017] Further, the traditional Chinese medicine preparation is made into oral liquid, capsule, granules and tablets.

[0018] The present application is composed of Gastrodia elata, Jujube seed, Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Rehmannia glutinosa and Crataegus pinnatifida, has the effects of nourishing blood and calming the nerves, calming the liver and extinguishing wind, promoting blood circulation and cooling blood, etc. Meanwhile, experiments prove that it can reduce the activity of acetylcholinesterase (AchE) in animal brain, increase the acetylcholine neurotransmitter, inhibit the activity of beta secretase and increase the activity of alpha secretase in brain, decompose the beta amyloid precursor in a normal direction, reduce the beta amyloid deposition, thereby slowing down the formation of senile plaques, and restore and enhance the patient's interest in life and work, memory and cognitive ability.

[0019] The above-mentioned traditional Chinese medicines can be found in Chinese Pharmacopoeia or other traditional Chinese medicine books for their alias, Latin name and place of production, usage, etc. In order to understand the mechanism of the present application in treating and preventing diseases, the effects of each traditional Chinese medicine in the prescription and its role in the prescription are described as follows:

[0020] Gastrodia elata: slightly warm, rhizome. Function: calming the liver and extinguishing wind, calming the liver and hiding yang, calming and expelling wind. Indications: headache, dizziness, convulsions, tetanus, infantile convulsions, numbness, rheumatism, etc. Dosage: 1-3 coins. Gastrodia elata is the monarch drug, combined with Jujube seed, Poria cocos, Codonopsis pilosula, Atractylodes macrocephala, Rehmannia glutinosa and Crataegus pinnatifida, and is mainly used for treating nervous depression with headache and insomnia.

[0021] Jujube seed: seed. Function: nourishing the heart and calming the nerves, nourishing the liver and calming the heart, generating fluid and stopping thirst, nourishing yin and tonifying the kidney, nourishing the liver and stopping sweating. Indications: heart yin deficiency, palpitation and forgetfulness, insomnia and dreaminess, virtual insomnia, blood deficiency dizziness, night sweat. Dosage: 3-4 coins. It is the ministerial drug.

[0022] Poria cocos: the dried sclerotium of a fungus of the family Polyporaceae. It is sweet and bland in flavor and neutral in nature. It belongs to the heart, spleen and kidney channels. It has the functions of removing dampness, strengthening the spleen and stomach, calming the heart and soothing the nerves, and strengthening the essence and marrow. It is a ministerial herb that treats heart-spleen deficiency, heart-kidney disharmony, insomnia, forgetfulness, edema, and other conditions. Famous doctor Hong Zhu Shu uses Poria cocos and licorice in every prescription.

[0023] Poria cocos has the functions of strengthening the spleen, removing dampness, stopping diarrhea, calming the heart, and soothing the nerves. It is sweet and bland in flavor, and neutral in nature. It belongs to the heart, spleen, and kidney channels.

[0024] Codonopsis root; sweet and flat, function; tonifying qi, tonifying spleen, tonifying lung, tonifying qi and generating fluid. Indications; weak spleen and stomach, lung deficiency

[0025] asthma, self-hemorrhage, and other conditions.

[0026] Atractylodes; sweet and bitter, function; tonifying spleen, drying dampness, strengthening spleen, and stopping diarrhea. Indications; spleen deficiency, diarrhea, edema, and other conditions.

[0027] Rehmannia; sweet and bitter, cold. Function; clearing heat and cooling blood, nourishing yin. Indications; fever with skin rash, thirst, red tongue, sore throat, and other conditions.

[0028] Hawthorn; sour and sweet, warm, function; digesting and removing stagnation, removing blood stasis and pain. Indications; meat accumulation, abdominal distension, diarrhea, and other conditions. Animal experiments show that it can dilate blood vessels and have a lasting effect on lowering blood pressure.

[0029] The above drugs have the effects of nourishing blood and soothing the nerves, calming the liver and extinguishing wind, and promoting blood circulation and cooling blood. Experiments have shown that they can reduce the activity of acetylcholinesterase (AchE) in the brain of animals, increase the release of acetylcholine neurotransmitters, and inhibit the activity of β-secretase and increase the activity of α-secretase in the brain, so that the β-amyloid precursor is decomposed in the normal direction, reducing the deposition of β-amyloid, thereby slowing down the formation of senile plaques; restoring the spirit, restoring and enhancing the memory and cognitive ability of patients. It is suitable for the treatment of headache, insomnia, and depression.

[0030] The above composition can be used as a prescription for headache, insomnia, and depression for patients to decoct and take; it is more suitable for modern pharmaceutical companies to extract its effective components and make oral liquid, capsules, granules, tablets, and other pharmaceutical dosage forms.

[0031] A production method of a traditional Chinese medicine preparation for preventing and treating insomnia and depression, the specific process of the production method of the oral liquid is:

[0032] (1) Take Gastrodia elata, Suanzaoren, Codonopsis, Atractylodes, Poria cocos, Rehmannia, and Hawthorn, weigh them, and then add 5-8 times the amount of water to decoct twice, each time for 2-3 hours, and combine them as A liquid;

[0033] (2) Put A liquid into the pot and heat to concentrate, get concentrated liquid B;

[0034] (3) After concentrated liquid B is cooled, add 3 times volume ratio of 95% ethanol, mix evenly, stand for 16-24 hours in refrigerator or ice storage at 4-8℃, filter and remove precipitate;

[0035] (4) Recover ethanol from filtrate, put the filtrate into ethanol recovery device and heat to recover ethanol, put the medicine liquid after recovering ethanol into the pot and heat to concentrate, volatilize a small amount of residual ethanol, get medicine liquid C;

[0036] (5) Take C liquid, add sugar syrup, mix evenly, fill, sterilize, get finished product oral liquid.

[0037] A production method of a traditional Chinese medicine preparation for preventing and treating insomnia and depression, the specific process of the capsule production method is as follows:

[0038] (1) Take Gastrodia, Suanzaoren, Dangshen, Baizhu, Fuling, Shengdi and Shanzha, weigh, add 5-8 times amount of water and decoct twice, each time for 2-3 hours, combine as A liquid;

[0039] (2) Put A liquid into the pot and heat to concentrate, get concentrated liquid B;

[0040] (3) After concentrated liquid B is cooled, add 3 times volume ratio of 95% ethanol, mix evenly, stand for 16-24 hours in refrigerator or ice storage at 4-8℃, filter and remove precipitate;

[0041] (4) Recover ethanol from filtrate, put the filtrate into ethanol recovery device and heat to recover ethanol, put the medicine liquid after recovering ethanol into the pot and heat to concentrate, volatilize a small amount of residual ethanol, get medicine liquid D;

[0042] (5) Continue to heat and concentrate D liquid into flow extract E, spray dry, get intermediate product dry extract powder F;

[0043] (6) Take intermediate product dry extract powder F and mixing material, granulate, fill into capsules, aluminum foil package, sub-pack, get finished product capsule.

[0044] A production method of a traditional Chinese medicine preparation for preventing and treating insomnia and depression, the specific process of the granule production method is as follows:

[0045] (1) Take Gastrodia, Suanzaoren, Dangshen, Baizhu, Fuling, Shengdi and Shanzha, weigh, add 5-8 times amount of water and decoct twice, each time for 2-3 hours, combine as A liquid;

[0046] (2) Put A liquid into the pot and heat to concentrate, get concentrated liquid B;

[0047] (3) After concentrated liquid B is cooled, add 3 times volume ratio of 95% ethanol, mix evenly, stand for 16-24 hours in refrigerator or ice storage at 4-8℃, filter and remove precipitate;

[0048] (4) filter liquor recovery ethanol, the filter liquor is placed in the ethanol recovery device, heated to recover ethanol, the medicine liquid after recovering ethanol is placed in the pot to heat and concentrate, and a small amount of ethanol is volatilized, and medicine liquid D is obtained;

[0049] (5) continue to heat and concentrate D liquid into flow extract E, spray dry to obtain intermediate product dry extract powder F;

[0050] (6) take the intermediate product dry extract powder F and mix with appropriate amount of excipients, granulate, dry, and pack to obtain the finished granules.

[0051] A production method of a traditional Chinese medicine preparation for preventing and treating insomnia and depression, and a specific process of a tablet production method is as follows:

[0052] (1) take Gastrodia, Suanzaoren, Dangshen, Baizhu, Fuling, Shengdi and Shanzha, and then weigh and decoct twice with 5-8 times the amount of water, each time for 2-3 hours, and combine to obtain A liquid;

[0053] (2) place the A liquid in the pot to heat and concentrate to obtain concentrated liquid B;

[0054] (3) after the concentrated liquid B is cooled, 3 times the volume of 95% ethanol is added and mixed uniformly, and then the mixture is placed in a refrigerator or ice storage at 4-8 DEG C for 16-24 hours, filtered and the precipitate is removed;

[0055] (4) filter liquor recovery ethanol, the filter liquor is placed in the ethanol recovery device, heated to recover ethanol, the medicine liquid after recovering ethanol is placed in the pot to heat and concentrate, and a small amount of ethanol is volatilized, and medicine liquid D is obtained;

[0056] (5) continue to heat and concentrate D liquid into flow extract E;

[0057] (6) take the intermediate product flow extract E and mix with excipients to granulate, press into tablets, and pack to obtain the finished tablets.

[0058] The taking method of the traditional Chinese medicine preparation is as follows:

[0059] Oral liquid, 10 ml each time, 2-3 times a day;

[0060] Capsule, 2 capsules each time, 2-3 times a day;

[0061] Granules, 1 bag each time, 2-3 times a day, 7 grams per bag;

[0062] Tablets, 2-3 tablets each time, 2-3 times a day, 0.3 grams per tablet.

[0063] The present application has the following beneficial effects due to the adoption of the above technical scheme:

[0064] (1)The application is made so that each medicine cooperates with each other, takes the advantages and makes up the shortcomings, nourishes blood, tranquilizes the nerves, soothes the liver and extinguishes the wind, promotes blood circulation to remove blood stasis, diuresis, removes dampness, invigorates the spleen, treats both the symptoms and the root cause, and protects the important organ functions of the body.

[0065] (2)The application overcomes the shortcomings of western medicine. In the absence of a radical drug, the product is made of traditional Chinese medicine, has a mild effect, is non-toxic, is convenient to eat, and is suitable for wide prevention and treatment.

[0066] (3)According to the results of animal experiments, the application simultaneously proves that the activity of acetylcholinesterase (AchE) in the brain of animals is reduced, the acetylcholine neurotransmitter is increased, the activity of beta secretase is inhibited and the activity of alpha secretase is increased in the brain, the beta amyloid precursor is decomposed in a normal direction, the deposition of beta amyloid is reduced, thereby slowing down the formation of senile plaques, and the memory and cognitive ability of patients are restored and enhanced. The application is suitable for the treatment of insomnia and depression.

[0067] (4)Clinical verification shows that the basic prescription of Gastrodia elata and Suanzaoren decoction has remarkable curative effect on treating blood-nourishing and nerve-calming, mainly for insomnia and neurasthenia.

[0068] (5)The raw materials are easy to obtain, the prescription is scientific and not complicated, the production process is advanced, the product is moderately priced, and the product is suitable for industrial production.

[0069] (6)According to the requirements of the properties of the effective components, the production process of water extraction and alcohol precipitation and sterilization is adopted, the effective components of the product are high, the product is easily absorbed by the human body, is not easy to deteriorate, and has a long shelf life.

[0070] (7)The raw materials used in the application are mostly food and medicine homologues, and no toxic and side effects are found in acute toxicity experiments and according to the daily dose and treatment period. DETAILED DESCRIPTION

[0071] In order to make the purpose, technical scheme and advantages of the application clearer and more apparent, the following preferred embodiments are given to further illustrate the application. However, it should be noted that many details in the specification are only to make the reader have a thorough understanding of one or more aspects of the application, and the aspects of the application can be realized without these specific details.

[0072] The traditional Chinese medicine preparation for preventing and treating depression is made of the following weight fractions of effective components of traditional Chinese medicine raw materials: Gastrodia elata 3-5 (parts), Suanzaoren 5-10 (parts), Codonopsis 5-10 (parts), Atractylodes 5-10 (parts), Poria 5-10 (parts), Rehmannia 5-10 (parts), and Hawthorn 5-10 (parts).

[0073] The above drugs are used together, which has the effects of nourishing blood, calming the nerves, calming the liver and extinguishing wind, activating blood and cooling blood. At the same time, experiments show that the activity of acetylcholinesterase (AchE) in the brain of animals is reduced, the acetylcholine neurotransmitter is increased, and the activity of β-secretase is inhibited and the activity of α-secretase is increased in the brain, so that the β-amyloid precursor is decomposed in the normal direction, the β-amyloid protein deposition is reduced, thereby slowing down the formation of senile plaques; the spirit is restored, the memory and cognitive ability of patients are restored and enhanced. It is suitable for the treatment of headache, insomnia and depression.

[0074] The above composition can be used as a prescription for headache, insomnia and depression for patients to decoct and take; it is more suitable for modern pharmaceutical enterprises to extract its effective components to produce oral liquid, capsule, granules, tablets and any dosage form in pharmaceutical science. The specific production method is as follows:

[0075] Production method of oral liquid:

[0076] (1) Take Gastrodia tuber, Suanzaoren, Dangshen, Baizhu, Fuling, Shengdi and Shanzha, weigh and add 5-8 times the amount of water to decoct twice, each time for 2-3 hours, and combine as A liquid.

[0077] (2) Put the above A liquid into a pot and heat to concentrate to obtain concentrated liquid B.

[0078] (3) After B is cooled, add 3 times (volume ratio) of 95% ethanol, mix well, and place in a refrigerator or ice storage at 4-8°C for 16-24 hours. Filter and remove the precipitate.

[0079] (4) Recover ethanol from the filtrate. Place the above filtrate in an ethanol recovery device and heat to recover ethanol. After recovering ethanol, place the liquid in a pot and heat to concentrate appropriately to volatilize a small amount of residual ethanol. Obtain liquid C.

[0080] (5) Take liquid C, add an appropriate amount of syrup, mix well, fill, sterilize, and obtain the finished oral liquid.

[0081] Production method of capsule:

[0082] (1) The water extraction and alcohol precipitation method of the medicine is the same as that of the oral liquid, and liquid D is obtained.

[0083] (2) Continue to heat and concentrate D liquid into flow extract E. Spray dry to obtain intermediate product dry extract powder F.

[0084] (3) Take the intermediate product F and an appropriate amount of auxiliary materials, mix well, granulate, fill into capsules, aluminum foil package, and sub-packaging to obtain the finished capsule.

[0085] Production method of granules:

[0086] (1) The water extraction and alcohol precipitation method of the medicine is the same as that of the capsule, and dry extract powder F is obtained.

[0087] 2. Take the intermediate product dry powder F and appropriate amount of excipients, granulation, drying, packaging, get finished granules.

[0088] The production method of the tablet is as follows:

[0089] 1. The medicine water extraction and alcohol precipitation method is the same as that of the oral liquid, and the liquid medicine D is obtained.

[0090] 2. The liquid D is continuously heated and concentrated into a flow extract E.

[0091] 3. Take the intermediate product flow extract E and appropriate amount of excipients, granulation, tabletting, packaging, get finished tablets.

[0092] The taking method is as follows:

[0093] The oral liquid is taken 2 to 3 times a day, 10 ml each time. The capsule is taken 2 to 3 times a day, 2 capsules each time. The granules are taken 2 to 3 times a day, 1 bag each time, 7 g per bag. The tablet is taken 2 to 3 times a day, 2 to 3 tablets each time, 0.3 g per tablet.

[0094] The following are the experimental data of the present application:

[0095] Experiment 1:

[0096] Mice were intraperitoneally injected with maltol aluminum for 40 days to establish a model, and then intragastrically administered with traditional Chinese medicine for 15 days. The treatment group 1 was Yuansang Buxie Liquid, and the treatment group 2 was Tianren Liquid (the present application). At the end, the mice's brains and blood were taken for measurement. The brain was made into 10% brain homogenate with 0.01M phosphate buffer at pH 7.4, and enzyme-linked immunosorbent assay was used for measurement.

[0097] 1. The results showed that in the aluminum poisoning group, the brain beta-secretase activity was significantly reduced in the normal group and the treatment group 2, indicating that the Tianren Liquid of the present application can reduce the generation of age spots by inhibiting the activity of beta-secretase and restore the brain memory function.

[0098] Table 1 Comparison of brain beta-secretase, alpha-secretase, and gamma-secretase (u / L) of mice in each group

[0099] ANOVA analysis of group comparison: brain beta-secretase: F=5.597, P=0.002, compared with the normal group,

[0100] P<0.05, compared with the treatment group 2, ▲▲ P<0.01, the difference was statistically significant; brain alpha-secretase: F=4.253, P=0.010, compared with the treatment group 2, ▲▲ P<0.01, the difference was statistically significant; brain gamma-secretase: F=2.114, P=0.113, compared with the treatment group 2, ▲P<0.05, difference was statistically significant; (treatment 2 group was the present party Tian-Ren drink)

[0101] 2, the activity of mouse brain acetylcholinesterase AchE, serum total cholesterol TC, triglyceride TG content determination results. The results show that the activity of acetylcholinesterase AchE in the model group is increased, the activity of treatment group 1 and treatment group 2 is decreased, the decomposition of acetylcholine neurotransmitter is regulated and slowed down, the balance is restored, and the memory is recovered. See Table 2.

[0102] Table 2 Comparison of acetylcholinesterase AchE, serum total cholesterol TC, triglyceride TG of each group of mice

[0103]

[0104]

[0105] Analysis of variance between groups: acetylcholinesterase AchE: F = 3.304, P = 0.029, compared with the model group, ▲ P<0.05, ▲▲ P<0.01, the difference was statistically significant; total cholesterol TC, F = 7.809, P = 0.000, compared with the normal group, ▲ P<0.05, ▲▲ P<0.01, compared with treatment group 1, ★★ P<0.01, the difference was statistically significant; triglyceride TG, F = 2.590, P = 0.063, compared with the normal group, ▲▲ P<0.01, the difference was statistically significant; (treatment 2 group was the present party)

[0106] 3. Memory function determination. Before modeling, the water maze time was basically the same, and after modeling, the water maze time was significantly prolonged, but the normal group was shorter, indicating that the memory function of other groups was more affected; after treatment, the water maze time of each group was shortened, and the treatment group was shortened more.

[0107] Table 3 Comparison of water maze time of each group before, during and after the experiment (seconds per mouse per time)

[0108]

[0109] Analysis of variance: comparison between groups, before modeling, comparison between groups, F = 0.707, P = 0.552, P> 0.05, the difference was not statistically significant. After modeling, F = 3.265, P = 0.030, compared with the normal group, ▲ <0.05, ▲▲ P<0.01, the difference was statistically significant. After treatment, compared with the normal group, ▲ P<0.05,▲▲ P<0.01, the difference was statistically significant. The time of normal group was basically unchanged before, during and after the experiment, the time of model group was significantly prolonged after modeling, and the time of treatment group was significantly shortened after treatment.

[0110] 4. The weight of mice in each group was measured before, during and after the experiment. The results showed that the weight of each group was basically consistent before the experiment; during the experiment, the weight of each group increased, but the normal group increased the most, and there was a significant difference between groups; after the experiment (after treatment), there was still a significant difference between groups, and the normal group was the highest, followed by the treatment group 2. See Table 4.

[0111] Table 4 Comparison of the weight of mice in each group before, during and after the experiment (g per mouse)

[0112]

[0113]

[0114] Analysis of variance between groups: before weight: F=1.266, P=0.295, the difference was not statistically significant; during weight: F=4.652, P=0.006, compared with the normal group, ▲ P<0.05, ▲▲ P<0.01, the difference was statistically significant; after weight: F=6.495, P=0.001, compared with the normal group, ▲▲ P<0.01, the difference was statistically significant; (Note: treatment group 1 is Yuan Sang group, and treatment group 2 is Tian-Ren group)

[0115] Intra-group comparison: normal group, F=76.744, P=0.000, compared with before, aP<0.01, the difference was statistically significant; model group, F=37.670, P=0.000, compared with before, aP<0.01, compared with during, bP<0.05, the difference was statistically significant; treatment group 1, F=26.515, P=0.003, compared with before, aP<0.01, the difference was statistically significant; treatment group 2, F=43.443, P=0.000, compared with before, aP<0.01, the difference was statistically significant.

[0116] The remaining matters of the present application are known technologies.

[0117] The above is only the preferred embodiment of the present application, and it should be noted that for ordinary skilled persons in the art, without departing from the principles of the present application, a number of improvements and refinements can be made, and these improvements and refinements should also be considered as the protection scope of the present application.

Claims

1. A traditional Chinese medicine preparation for preventing and treating insomnia and depression, characterized in that: Made from the following Chinese medicinal materials in parts by weight: Gastrodia elata 3-5 parts, Ziziphus jujuba var. spinosa 5-10 parts, Codonopsis pilosula 5-10 parts, Atractylodes macrocephala 5-10 parts, Poria cocos 5-10 parts, Rehmannia glutinosa 5-10 parts, Crataegus pinnatifida 5-10 parts.

2. The traditional Chinese medicine preparation for preventing and treating insomnia and depression according to claim 1, characterized in that: It is used to treat headaches, insomnia, and depression.

3. The traditional Chinese medicine preparation for preventing and treating insomnia and depression according to claim 1, characterized in that: It can be formulated into oral liquids, capsules, granules, and tablets.

4. The production method of a traditional Chinese medicine preparation for preventing and treating insomnia and depression according to claim 3, characterized in that: The specific process of producing oral liquid is as follows: (1) Take Gastrodia elata, Ziziphus jujuba var. spinosa, Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Rehmannia glutinosa, and Crataegus pinnatifida. Weigh them, add 5-8 times the amount of water, and decoct twice, 2-3 hours each time. Combine the decoctions to form solution A. (2) Heat and concentrate liquid A in a pot to obtain concentrated liquid B; (3) After cooling the concentrate B, add 3 times the volume of 95% ethanol, mix well, and let stand for 16-24 hours in a refrigerator or ice room at 4°C to 8°C. Filter to remove the precipitate. (4) Filtrate recovery of ethanol: Place the filtrate in an ethanol recovery device and heat to recover ethanol. After ethanol recovery, heat the liquid in a pot to concentrate and evaporate the small amount of residual ethanol to obtain liquid c. (5) Take liquid c, add syrup, mix well, fill, sterilize, and obtain the finished oral liquid.

5. The method for producing a traditional Chinese medicine preparation for preventing and treating insomnia and depression according to claim 3, characterized in that: The specific process of capsule production is as follows: (1) Take Gastrodia elata, Ziziphus jujuba var. spinosa, Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Rehmannia glutinosa, and Crataegus pinnatifida. Weigh them, add 5-8 times the amount of water, and decoct twice, 2-3 hours each time. Combine the decoctions to form solution A. (2) Heat and concentrate liquid A in a pot to obtain concentrated liquid B; (3) After cooling the concentrate B, add 3 times the volume of 95% ethanol, mix well, and let stand for 16-24 hours in a refrigerator or ice room at 4°C to 8°C. Filter to remove the precipitate. (4) Filtrate recovery of ethanol: Place the filtrate in an ethanol recovery device and heat to recover ethanol. After ethanol recovery, heat the liquid in a pot to concentrate and evaporate the small amount of residual ethanol to obtain liquid D. (5) Continue heating and concentrating liquid D into fluid extract E, then spray drying to obtain intermediate product dry extract powder F; (6) Take the intermediate product dry powder F, mix it with the excipients, granulate it, fill it into capsules, package it with aluminum foil, and repackage it to obtain the finished capsules.

6. The method for producing a traditional Chinese medicine preparation for preventing and treating insomnia and depression according to claim 3, characterized in that: The specific process of granule production is as follows: (1) Take Gastrodia elata, Ziziphus jujuba var. spinosa, Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Rehmannia glutinosa, and Crataegus pinnatifida. Weigh them, add 5-8 times the amount of water, and decoct twice, 2-3 hours each time. Combine the decoctions to form solution A. (2) Heat and concentrate liquid A in a pot to obtain concentrated liquid B; (3) After cooling the concentrate B, add 3 times the volume of 95% ethanol, mix well, and let stand for 16-24 hours in a refrigerator or ice room at 4°C to 8°C. Filter to remove the precipitate. (4) Filtrate recovery of ethanol: Place the filtrate in an ethanol recovery device and heat to recover ethanol. After ethanol recovery, heat the liquid in a pot to concentrate and evaporate the small amount of residual ethanol to obtain liquid D. (5) Continue heating and concentrating liquid D into fluid extract E, then spray drying to obtain intermediate product dry extract powder F; (6) Take the intermediate product dry powder F and mix it with an appropriate amount of excipients, granulate, dry, and package to obtain the finished granules.

7. The production method of a traditional Chinese medicine preparation for preventing and treating insomnia and depression according to claim 3, characterized in that: The specific process of tablet production is as follows: (1) Take Gastrodia elata, Ziziphus jujuba var. spinosa, Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Rehmannia glutinosa, and Crataegus pinnatifida. Weigh them and add 5-8 times the amount of water to decoct twice, each time for 2-3 hours. Combine the decoctions to form solution A. (2) Heat and concentrate liquid A in a pot to obtain concentrated liquid B; (3) After cooling the concentrate B, add 3 times the volume of 95% ethanol, mix well, and let stand for 16-24 hours in a refrigerator or ice room at 4°C to 8°C. Filter to remove the precipitate. (4) Filtrate recovery of ethanol: Place the filtrate in an ethanol recovery device and heat to recover ethanol. After ethanol recovery, heat the liquid in a pot to concentrate and evaporate the small amount of residual ethanol to obtain liquid D. (5) Continue heating and concentrating liquid D into a fluid extract paste E; (6) Take the intermediate product fluid extract E and mix it with excipients, granulate, compress, and package to obtain finished tablets.

8. A traditional Chinese medicine preparation for preventing and treating insomnia and depression according to claim 3, characterized in that: The method of administration is as follows: Oral solution, 2 to 3 times a day, 10ml each time; Capsules, 2 to 3 times a day, 2 capsules per day; Granules, 2 to 3 times a day, 1 sachet each time, 7 grams per sachet; Tablets, 2 to 3 times a day, 2 to 3 tablets each time, each tablet weighing 0.3 grams.

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