Novel Chinese herbal medicine composition and preparation method thereof

Abstract

The invention discloses a new Chinese herbal medicine composition for relieving anxiety and a preparation method of the new Chinese herbal medicine composition, and solves the problem of side effects in the existing treatment of anxiety and dysphoria. The feed comprises Chinese herbal medicine components, vitamins, minerals and nutritional supplements, wherein the Chinese herbal medicines comprise a ginseng extract, a liquorice extract and a rhodiola rosea extract; the vitamins comprise vitamin B1, vitamin B2, vitamin B6, folic acid and vitamin B12; the mineral substance is magnesium ions; the nutritional supplement comprises choline, nicotinic acid, pantothenic acid, inositol and gamma-aminobutyric acid. The method directly aims at the hippocampus of the brain, the generation of glutamic acid (an excitatory neurotransmitter) in the hippocampus can be balanced, the hippocampus is located in the emotion-related brain area, and the symptoms of various cognition and emotion problems can be relieved by promoting the balance of the glutamic acid in the hippocampus.

Description

Technical Field

[0001] The present invention belongs to the technical field of drug preparation, and particularly relates to a new Chinese herbal medicine composition for relieving anxiety and a preparation method thereof. Background Art

[0002] Anxiety disorder is one of the most common mental illnesses, characterized by continuous and long-term bad mood as the main clinical feature, and is the most important type of mental illness. It is manifested as continuous and excessive anxiety and worry, resulting in impaired daily life function. The clinical manifestations are bad mood and unhappy life, with a long-term low and depressed mood, from being sullen at the beginning to being heartbroken at the end, self-abased, painful, pessimistic, world-weary, feeling that every day of living is torturing oneself desperately, negative, avoiding, and finally even having suicidal attempts and behaviors. According to the data of the World Health Organization (WHO), anxiety disorder is the most common mental illness globally, with a lifetime prevalence of 18.1% and a 12-month prevalence of 8.4% among adults worldwide.

[0003] In China, according to the survey of the Chinese Center for Disease Control and Prevention (CDC), the lifetime prevalence of anxiety disorder among adults is 7.57%, and the 12-month prevalence is 4.98%. Among them, the prevalence rate of women is higher than that of men, which are 8.9% and 6.2% respectively. At present, the etiology of anxiety disorder is not very clear, but studies have found that many factors in the physical, psychological and social environments are related to the onset of depression. It mainly involves factors in aspects such as genetics, neuroendocrine, and digestive systems.

[0004] Currently, the treatment effect on anxiety and restlessness is limited. Commonly used drugs are mostly anti-anxiety drugs such as paroxetine and fluoxetine to relieve the condition, and they need to be used reasonably under the guidance of a doctor. These drugs are convenient, fast, have definite curative effects, take effect quickly, and have a wide range of effects, but the treatment results are inconsistent and have certain side effects, and can cause adverse reactions such as dependence and rebound insomnia, seriously affecting the normal work, study and life of patients. Summary of the Invention

[0005] The purpose of the present invention is to provide a new Chinese herbal medicine composition for relieving anxiety and a preparation method thereof, so as to solve the problems in the prior art that the treatment effect on anxiety and restlessness is limited and the commonly used drugs have certain side effects.

[0006] To achieve the above purpose, the present invention provides the following technical solutions: A new Chinese herbal medicine composition for relieving anxiety provided by the present invention, the composition includes components of Chinese herbal medicine, vitamins, minerals and nutritional supplements; The Chinese herbal medicine is: ginseng extract, licorice extract, rhodiola extract.

[0007] The vitamins include vitamin B1, vitamin B2, vitamin B6, folic acid, and vitamin B12; The mineral is magnesium ion; The nutritional supplements include choline, niacin, pantothenic acid, inositol, and γ-aminobutyric acid; The content of the Chinese herbal medicines is as follows: 50 - 150 mg of ginseng extract, 50 - 110 mg of licorice extract, and 100 - 400 mg of rhodiola rosea extract.

[0008] The content of the vitamins is as follows: vitamin B1: 0.2 - 1.5 mg, vitamin B2: 0.3 - 1.7 mg, vitamin B6: 0.3 - 1.70 mg, folic acid: 300 - 800 μg, and vitamin B12: 1.4 - 3.0 μg.

[0009] Furthermore, the content of the magnesium ion is 10 - 100 mg.

[0010] Furthermore, the content of the nutritional supplements is as follows: choline: 25 - 200 mg, niacin: 9 - 20 mg, pantothenic acid: 5 - 10 mg, inositol: 10 - 90 mg, and γ-aminobutyric acid: 5 - 10 mg.

[0011] The present invention provides a preparation method of a new Chinese herbal medicine composition for relieving anxiety, in capsule dosage form.

[0012] 1. Prescription (by weight): Prepare 1000 capsules (No. 0 capsules), 0.54 g per capsule.

[0013] 100 g of ginseng extract 80 g of licorice extract 200 g of rhodiola rosea extract 0.75 g of vitamin B1 0.82 g of vitamin B2 0.82 g of vitamin B6 0.4 g of folic acid 1.5 mg of vitamin B12 50 g of choline 5 g of niacin 4 g of pantothenic acid 25 g of inositol 5 g of γ-aminobutyric acid 66 g of starch 2. Preparation method: 1) Weigh the ginseng extract, licorice extract, rhodiola extract and starch according to the formula, sieve them through a 40-mesh sieve respectively, and set aside; first weigh 1.5 mg of vitamin B12 and 0.25 mg of vitamin D3 according to the formula, and then add vitamins, magnesium ions, nutrients and Chinese herbal medicine components in turn. After each addition, it is necessary to mix evenly.

[0014] 2) Mix the above-mentioned raw and auxiliary materials evenly by the equal increment addition method, pour them into the capsule filling mold, fill the capsules, polish them, and divide them into packages.

[0015] 3. Specification: Each capsule contains 100 mg of ginseng extract, 80 mg of licorice extract, 200 mg of rhodiola extract and other composition components.

[0016] 4. Administration method: Take 2 times a day, 1 capsule each time.

[0017] Based on the above technical solutions, the embodiments of the present invention can at least produce the following technical effects: (1) The present invention provides a new Chinese herbal medicine composition for relieving anxiety and its preparation method, which is a combination of Chinese herbal medicine, vitamins, minerals and nutritional supplements. It directly focuses on and targets the hippocampal region of the brain, and can balance the production of glutamate (an excitatory neurotransmitter) in the hippocampus. The hippocampus is located in the brain region related to emotions. Promoting the balance of glutamate in the hippocampus may relieve the symptoms of various cognitive and emotional problems. All anxiety-based diseases are related to the hippocampal region. The composition of the present invention directly targets the anxiety site in the hippocampus and improves its function because of the subordinate relationship and compulsive disorder existing in anxiety disorders. This composition shows an obvious relief effect on affected patients, increases memory, improves fine motor skills and language ability, and at the same time reduces anxiety, stress and restlessness, which make social interaction and life of anxiety and other anxiety disorders more difficult.

[0018] (2) The present invention provides a new Chinese herbal medicine vitamin composition for relieving anxiety and its preparation method. The composition is a revolutionary reform of the current anxiety drug regimen. The first feature is that it can control and relieve anxiety symptoms. The second feature is that this patent is the only known drug on the market that acts on the potential effect of the hippocampus. Approximately 80% of patients benefit and the effect takes effect within 24 to 96 hours. The social behavior of patients has been significantly improved, anxiety symptoms have been reduced, and the quality of life of patients and their families has been significantly improved. Detailed implementation mode

[0019] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention. In addition, the technical solutions between various embodiments can be combined with each other, but it must be based on the fact that those of ordinary skill in the art can implement them. When the combination of technical solutions conflicts with each other or cannot be implemented, it should be considered that such a combination of technical solutions does not exist and is not within the protection scope required by the present invention.

[0020] The composition used has the following functions: Ginseng: Changbai Mountain ginseng is a natural ginseng in China, with miraculous effects and extremely high medicinal value. Ginseng extract can improve brain function, enhance mental state, improve brain thinking and memory, improve human attention and response speed, and prevent brain degeneration and senile Alzheimer's syndrome. It can relieve stress and fatigue.

[0021] Licorice Root: Licorice is a plant with relatively high medicinal value. Western medicine has used licorice as an expectorant, cough suppressant and sweetener since ancient Greece. In the ancient Chinese pharmacopoeia "Shennong Ben Cao Jing", licorice was described as a drug for strengthening muscles and bones, increasing physical strength and treating wounds, and was listed as a top-grade medicine, calling this herb the king of all medicines, and it is rarely used in prescriptions without it. In traditional Chinese medicine, licorice belongs to the heart, lung, spleen and stomach meridians; it has the effects of invigorating the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, relieving spasm and pain, and coordinating various medicines. It is used for heart qi deficiency, mainly treating spleen and stomach weakness, fatigue and weakness, palpitations and shortness of breath, cough with excessive phlegm, abdominal and limb spasmodic pain, and relieving the toxicity and potency of drugs.

[0022] Rhodiola Rosea Root: It is the root of the plant Rhodiola rosea. The bioactive compounds in Rhodiola rosea extract can reduce stress, relieve fatigue, alleviate symptoms of depression and insomnia, while promoting emotional stability, supporting cognitive functions such as memory and attention, and improving exercise performance.

[0023] Thiamine (vitamin B1) helps prevent nervous system, brain, heart, and gastrointestinal complications. Because it is involved in the movement of electrolytes in and out of muscle and nerve cells. Many B vitamins are called "anti-stress vitamins" because they can enhance the body's immune system when a person is under stress.

[0024] Riboflavin (vitamin B2) is essential for the normal development of multiple physiological systems such as the digestive tract, blood cells and brain function. The antioxidant, anti-aging, anti-inflammatory and anti-cancer properties of B2 have been widely studied.

[0025] Niacin (nicotinamide) is an important neuroprotective nutrient, especially in relation to neurodegenerative diseases (Alzheimer's, Parkinson's, and Huntington's diseases) and neuropathological conditions (ischemic and traumatic injuries, headache, and mental illness). Every part of the body requires niacin to function optimally, and as a supplement, it can help lower cholesterol, relieve arthritis, enhance brain function, etc.

[0026] Vitamin B6 (pyridoxine hydrochloride) plays an important role in mood regulation as it is crucial for the production of multiple neurotransmitters that regulate mood, such as serotonin, dopamine, and gamma-aminobutyric acid (GABA). It is also thought to potentially lower high levels of the amino acid homocysteine in the blood, which is associated with depression and other mental illnesses.

[0027] Folate: Is important for nervous system function in all age groups. Many studies have shown that folate deficiency is associated with negative mental health symptoms, especially depression and impaired social function. Folate deficiency is also associated with epilepsy and cognitive decline in the elderly population. Additionally, recent studies in the elderly have shown a link between folate, homocysteine, aging, depression, and dementia (including Alzheimer's disease and vascular disease).

[0028] Vitamin B12 (cyanocobalamin) is essential for the normal function of the brain and nervous system, the formation of red blood cells, and the production and regulation of DNA. B-12 deficiency is uncommon, but people with this condition are at risk of irreversible nerve and brain damage and may have a higher risk of developing psychosis, mania, and dementia.

[0029] Biotin is a B-complex vitamin that helps our bodies convert food into valuable energy. Although very rare, biotin deficiency is associated with diseases such as depression, lethargy, hallucinations, and epilepsy.

[0030] Pantothenic acid (D-calcium pantothenate) plays an important role in supporting metabolism, adrenal health, stress regulation, and helping with the proper utilization of PABA and choline (both present in this formula).

[0031] Choline (Choline bitartrate) is an important nutrient that supports important bodily functions such as cell maintenance, DNA synthesis, metabolism, and nervous system function. The cited benefits include improved memory and cognition, protection of heart health, promotion of metabolism, improvement of lung and liver symptoms in patients with cystic fibrosis, and reduction of the risk of pregnancy complications. Although the recommended daily intake is relatively low, most people still do not consume enough choline, and people with choline deficiency may be at risk of developing muscle and liver diseases, cardiovascular diseases, and dementia.

[0032] Magnesium ion (Magnesium Oxide): Magnesium is an important electrolyte in the human body. In normal people, the concentration of magnesium in the blood is 0.75 - 1.25 moles per liter. If the blood magnesium level is lower than this, it is called hypomagnesemia. Magnesium deficiency can lead to anxiety and depression, high blood pressure, insomnia, fatigue, and other adverse conditions. Magnesium can not only activate various enzymes in the body, regulate nerve function, maintain the stability of nucleic acid structure, participate in protein synthesis, and regulate body temperature, but also affect people's emotions. Clinically, in addition to potassium magnesium aspartate, commonly used magnesium supplements include magnesium gluconate, magnesium sulfate, and magnesium oxide. Magnesium may affect people's emotions in the following ways: 1) Magnesium can increase the concentration of 5 - hydroxytryptamine, making people feel calm, happy, and stress - free; 2) Magnesium can reduce the concentration of cortisol, which is a stress hormone; 3) Magnesium can reduce the concentration of adrenaline, which helps with sleep; 4) Magnesium can increase the concentration of gamma - aminobutyric acid (GABA), which is a neurotransmitter related to nerve relaxation, making people feel calm and easy to fall asleep; 5) Magnesium can increase the concentration of melatonin, which helps improve sleep; 6) Magnesium can increase the function of the parasympathetic nervous system, which can promote calmness and help with sleep. For example, magnesium oxide can help increase low magnesium levels, relieve constipation, control depression, and treat migraines.

[0033] Inositol is a carbohydrate that occurs naturally in the body and in foods. Inositol plays a role in a variety of bodily processes. Inositol is usually included in supplements because it can help balance certain chemicals in the body and help treat diseases such as panic disorder, depression, and obsessive - compulsive disorder.

[0034] Gamma - aminobutyric acid (GABA) is a naturally occurring amino acid in the human body that acts as a neurotransmitter or chemical messenger in the brain. Different from glutamate, GABA is called an inhibitory neurotransmitter because it blocks or inhibits certain brain signals, thus reducing the activity of the nervous system. When these neurotransmitters bind to GABA receptors, it can produce a sedative effect, helping to relieve anxiety, stress, and fear. Therefore, GABA is added to compositions to relieve the anxiety symptoms of patients diagnosed with epilepsy, Parkinson's disease, attention - deficit hyperactivity disorder, anxiety disorder, panic disorder, and depression. Example 1

[0035] Ginseng extract: 0.05 g, licorice extract: 0.10 g, rhodiola extract: 0.20 g; Vitamin B1: 100 mg, vitamin B2: 100 mg, vitamin B6: 100 mg, folic acid: 500 μg, vitamin B12: 150 μg; Magnesium ion content is 80 mg; Choline: 50 mg, niacin: 80 mg, pantothenic acid: 100 μg, inositol: 100 mg, γ-aminobutyric acid: 200 mg.

[0036] Ginseng extract: 0.10 g, licorice extract: 0.05 g, rhodiola extract: 0.20 g; Vitamin B1: 50 mg, vitamin B2: 150 mg, vitamin B6: 100 mg, folic acid: 500 μg, vitamin B12: 150 μg; Magnesium ion content is 100 mg; Choline: 30 mg, niacin: 100 mg, pantothenic acid: 80 μg, inositol: 120 mg, γ-aminobutyric acid: 200 mg.

[0037] Ginseng extract: 0.05 g, licorice extract: 0.10 g, rhodiola extract: 0.30 g; Vitamin B1: 150 mg, vitamin B2: 50 mg, vitamin B6: 200 mg, folic acid: 400 μg, vitamin B12: 150 μg; Magnesium ion content is 120 mg; Choline: 80 mg, niacin: 50 mg, pantothenic acid: 120 μg, inositol: 100 mg, γ-aminobutyric acid: 200 mg. Example 4

[0038] Ginseng extract: 0.10 g, licorice extract: 0.05 g, rhodiola extract: 0.10 g; Vitamin B1: 30 mg, vitamin B2: 150 mg, vitamin B6: 100 mg, folic acid: 600 μg, vitamin B12: 150 μg; Magnesium ion content is 80 mg; Choline: 50 mg, niacin: 80 mg, pantothenic acid: 100 μg, inositol: 80 mg, γ-aminobutyric acid: 250 mg. Example 5

[0039] Ginseng extract: 0.10 g, licorice extract: 0.05 g, rhodiola extract: 0.30 g; Vitamin B1: 120 mg, Vitamin B2: 10 mg, Vitamin B6: 50 mg, Folic Acid: 600 mcg, Vitamin B12: 100 mcg; The content of magnesium ions is 80 mg; Choline: 50 mg, Niacin: 30 mg, Pantothenic Acid: 180 mcg, Inositol: 180 mg, Gamma-Aminobutyric Acid: 50 mg. Comparative Example 1

[0040] Ginseng Extract: 0.05 g, Licorice Extract: 0.10 g, Rhodiola Extract: 0.15 g; Vitamin B1: 100 mg, Vitamin B2: 100 mg, Vitamin B6: 100 mg, Folic Acid: 500 mcg, Vitamin B12: 150 mcg; The content of magnesium ions is 80 mg; Choline: 50 mg, Niacin: 80 mg, Pantothenic Acid: 100 mcg, Inositol: 100 mg, Gamma-Aminobutyric Acid: 200 mg. Comparative Example 2

[0041] Ginseng Extract: 0.05 g, Licorice Extract: 0.10 g, Rhodiola Extract: 0.20 g; Vitamin B1: 100 mg, Vitamin B2: 100 mg, Vitamin B6: 100 mg, Folic Acid: 500 mcg, Vitamin B12: 150 mcg; Choline: 50 mg, Niacin: 80 mg, Pantothenic Acid: 100 mcg, Inositol: 100 mg, Gamma-Aminobutyric Acid: 200 mg.

[0042] Ginseng Extract: 0.05 g, Licorice Extract: 0.10 g, Rhodiola Extract: 0.20 g; The content of magnesium ions is 80 mg; Choline: 50 mg, Niacin: 80 mg, Pantothenic Acid: 100 mcg, Inositol: 100 mg, Gamma-Aminobutyric Acid: 200 mg.

[0043] Ginseng Extract: 0.05 g, Licorice Extract: 0.10 g, Rhodiola Extract: 0.20 g; Vitamin B1: 100 mg, Vitamin B2: 100 mg, Vitamin B6: 100 mg, Folic Acid: 500 mcg, Vitamin B12: 150 mcg; The content of magnesium ions is 80 mg. Test Example

[0044] Select 200 volunteers with anxiety. Among the 200 volunteers, 180 volunteers took the products of Examples 1-5 and Comparative Examples 1-4 respectively. According to the dosage, take it once before going to bed every day, 5 g each time, and take it continuously for 3 months with warm water. 20 volunteers did not take the product as a blank control.

[0045] The results of the anxiety relief test of 200 volunteers are shown in Table 1 below, and the sleep conditions are shown in Table 2 below: Table 1 Test results of using a new composition to relieve anxiety for 200 volunteers Number of volunteers Anxiety relief situation Anxiety relief effective rate Example 1 20 16 volunteers improved 80% Example 2 20 14 volunteers improved 70% Example 3 20 15 volunteers improved 75% Example 4 20 14 volunteers improved 70% Example 5 20 13 volunteers improved 65% Comparative Example 1 20 8 volunteers improved 40% Comparative Example 2 20 6 volunteers improved 30% Comparative Example 3 20 7 volunteers improved 35% Comparative Example 4 20 4 volunteers improved 20% Blank control 20 No change 0 Table 2 Test results of using a new composition to relieve sleep for 200 volunteers Number of volunteers Sleep situation Sleep improvement effective rate Example 1 20 17 volunteers improved 85% Example 2 20 16 volunteers improved 80% Example 3 20 16 volunteers improved 80% Example 4 20 15 volunteers improved 75% Example 5 20 15 volunteers improved 75% Comparative Example 1 20 8 volunteers improved 40% Comparative Example 2 20 6 volunteers improved 30% Comparative Example 3 20 7 volunteers improved 35% Comparative Example 4 20 5 volunteers improved 25% Blank control 20 No change 0 As can be seen from the above table, compared with the control group, the sleep time of those taking the formula provided by the product of the present invention increased significantly, and the number of times of their emotional anxiety also decreased significantly, indicating that the composition provided by the present invention has the effect of relieving the anxiety mood disorder and insomnia caused by stress.

[0046] The above shows and describes 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. What is described in the above embodiments and the specification only illustrates 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 these changes and improvements all fall within the scope of the present invention claimed. The scope of the present invention claimed is defined by the appended claims and their equivalents.

Claims

1. A new Chinese herbal medicine composition for relieving anxiety, characterized in that: The composition includes Chinese herbal medicine components, vitamins, minerals, and nutritional supplements; among which, the Chinese herbal medicines include ginseng extract, licorice extract, and rhodiola rosea extract; the vitamins include vitamin B1, vitamin B2, vitamin B6, folic acid, and vitamin B12; the mineral is magnesium ion; the nutritional supplements include choline, niacin, pantothenic acid, inositol, and γ-aminobutyric acid.

2. The anti - anxiety Chinese herbal medicine composition according to claim 1, characterized in that: The content of Chinese herbal medicines in each capsule is as follows: ginseng extract: 50 - 150 mg, licorice extract: 50 - 110 mg, rhodiola rosea extract: 100 - 400 mg.

3. The Chinese herbal medicine vitamin composition for relieving anxiety according to claim 1, wherein: The vitamin content in each capsule is as follows: vitamin B1: 0.2 - 1.5 mg, vitamin B2: 0.3 - 1.7 mg vitamin B6: 0.3 - 1.7 mg folic acid: 300 - 800 μg vitamin B12: 1.4 - 3.0 μg.

4. The Chinese herbal medicine composition for relieving anxiety according to claim 1, wherein: The content of magnesium ion is 10 - 100 mg.

5. The Chinese herbal medicine vitamin composition for relieving anxiety according to claim 1, characterized in that: The content of the nutritional supplements is as follows: choline: 25 - mg - 200 mg niacin: 9 - 20 mg pantothenic acid: 5 - 10 mg inositol: 10 - 90 mg γ-aminobutyric acid: 5 - 10 mg.

6. A preparation method of a new Chinese herbal medicine composition for relieving anxiety, which uses the Chinese herbal medicine vitamin composition for relieving anxiety described in claims 1-5, and is characterized in that, Specifically, it includes the following steps: Prepare 1000 capsules (No. 0 capsules), 0.54 g per capsule. 1) Weigh the ginseng extract, licorice extract, rhodiola rosea extract, and starch according to the formula, and pass them through a 40-mesh sieve respectively for standby; weigh vitamin B12, and add other vitamins in sequence. After each addition, it is necessary to mix evenly; 2) Mix the above raw and auxiliary materials evenly by the equal increment addition method, pour them into the capsule filling mold, fill the capsules, polish, and sub-pack; 3) Specification: Each capsule contains 100 mg of ginseng extract, 80 mg of licorice extract, 200 mg of rhodiola rosea extract, and other vitamin components; 4) Administration method: Take 2 times a day, 1 capsule each time.