Unconscious series of traditional Chinese medicine compositions for treating neurasthenia, insomnia and amnesia as well as preparation method and application of unconscious series of traditional Chinese medicine compositions

Abstract

The invention relates to an unconscious series traditional Chinese medicine composition for treating neurasthenia, insomnia and amnesia as well as a preparation method and application thereof. The composition is prepared from the following raw materials in parts by weight: 1200-2500 parts of lucid ganoderma, 1100-2550 parts of astragalus membranaceus, 20-70 parts of starch, 5-50 parts of white granulated sugar and 1-15 parts of magnesium stearate. The composition disclosed by the invention has a very good treatment effect on neurasthenia, insomnia and amnesia, and is free from any toxic and side effects and drug dependence.

Description

Technical Field

[0001] The present invention belongs to the technical field of medicine, and particularly relates to a traditional Chinese medicine composition for treating neurasthenia, insomnia and amnesia, and a preparation method and application thereof. Background Art

[0002] The main symptoms of neurasthenia are persistent fatigue or weakness, and there may also be symptoms such as chest pain and rapid heartbeat. Moreover, patients are overly sensitive to stimuli, such as being particularly sensitive to sounds, lights or slight physical discomfort sensations, and may also be complicated with sleep disorders, anxiety disorders and other diseases. Some patients have psychosomatic symptoms such as tinnitus, palpitation, chest tightness, indigestion, frequent urination, excessive sweating, impotence, or menstrual disorders. There will also be manifestations such as grogginess after getting up, feeling stiff in the morning, and being unable to concentrate.

[0003] The drugs for treating neurasthenia patients can be divided into the following types: (1) Anti-anxiety drugs: Commonly used benzodiazepines can help patients improve anxiety, tension and sleep disorders; (2) Sedative-hypnotic drugs: For those with obvious sleep disorders, triazolam, nitrazepam, estazolam, clonazepam, etc. can be selected; (3) β-blockers: For those with obvious symptoms of hyperfunction of the sympathetic nervous system, such as tension, palpitations, tremors, excessive sweating, etc., propranolol can be used, and it has a certain effect; (4) Tricyclic drugs: For those with a mixture of anxiety and depressive emotions and early awakening, doxepin or amitriptyline can be selected to relieve anxiety and depressive emotions and prolong sleep time. In order to avoid drug dependence, the above drugs should not be used for too long. At the same time, some drugs have more side effects, bringing great troubles to the physical and mental health of patients.

[0004] Insomnia refers to a subjective experience where patients are dissatisfied with the duration and quality of sleep and it affects their daytime social function. It means the inability to fall asleep or maintain sleep, resulting in insufficient sleep. It is also known as sleep onset and maintenance disorder (DlMS) and is the most common sleep disorder. In severe cases, patients may stay awake all night. It is often caused by various reasons such as difficulty falling asleep, short sleep depth or frequency, early awakening, and insufficient sleep duration or poor quality. It is a common disease. Clinically, its syndrome characteristics include difficulty falling asleep, easy waking up after sleep, inability to fall asleep again after waking up, waking up intermittently, being easily awakened, being sensitive to sounds or lights, or staying awake all night, and it is often accompanied by listlessness, slow reaction, physical fatigue during the day, and even annoyance. It seriously affects physical and mental health, work, study, and life. Insomnia is called "insomnia" in traditional Chinese medicine and "Ninglong disease" in Tibetan medicine. In ancient times, it was called "inability to lie down" or "inability to sleep". Insomnia disorder is a subjective experience where the quality or quantity of sleep cannot meet the normal physiological needs due to difficulty in maintaining sleep, which affects daytime social function and is the most common sleep disorder. Insomnia can cause inattention, memory loss, decreased judgment and daily work ability. In severe cases, it is combined with anxiety, compulsion, and depression. In addition, insomnia is also an independent risk factor for coronary heart disease and symptomatic diabetes. Therefore, correct diagnosis and treatment of insomnia are crucial for people's physical and mental health.

[0005] Forgetfulness refers to the decline of a person's memory and is a manifestation of the disorder of human intellectual activities. It is manifested as recent or long-term memory decline, easy to forget things, inattention, etc. Forgetfulness often accompanies insomnia symptoms. Insomnia patients often complain about their memory decline, being forgetful in doing things, often forgetting the places where items are stored, and unable to remember the names of acquaintances.

[0006] The forgetfulness symptoms of insomnia patients are different from the memory disorders caused by destructive brain lesions. The forgetfulness of insomnia patients is mainly due to inattention, mental fatigue, and lack of interest. While people with destructive brain lesions are unable to retain actual impressions in the brain at all and thus cannot reproduce them. The forgetfulness caused by insomnia is temporary and can be completely recovered.

[0007] Generally speaking, although the natures of insomnia and forgetfulness are different, they can affect each other. Insomnia can exacerbate forgetfulness, and forgetfulness will gradually worsen insomnia.

[0008] With the increasing work and life pressure of people, the number of patients with neurasthenia, insomnia, and forgetfulness has increased exponentially, and the quality of life has dropped sharply. There is a great market demand for the regulation and treatment of this disease.

[0009] Chinese Patent Application CN101700270A discloses a traditional Chinese medicine composition for neurasthenia, its preparation method and quality control method. The preparation method of the traditional Chinese medicine composition is as follows: Take 1000 parts of Astragalus membranaceus, decoct it twice with water, each time for 3 hours, filter it in batches, combine the filtrates, concentrate it into a paste, dry it at low temperature, and pulverize it to obtain Astragalus membranaceus paste powder; Take 500 parts of Ganoderma lucidum, break it into pieces as appropriate, decoct it twice with water, each time for 3 hours, filter it in batches, combine the filtrates, concentrate it into a paste, dry it at low temperature, and pulverize it to obtain Ganoderma lucidum paste powder; Mix the Ganoderma lucidum paste powder, Astragalus membranaceus paste powder and 15 parts of starch, granulate, dry, tablet, and coat to obtain tablets. This technology uses a simple water extraction and ordinary filtration method, with a low extraction rate of the extract and a low utilization rate of the medicinal materials, and cannot completely extract the effective components in the medicinal materials. Summary of the Invention

[0010] In order to overcome the defects of the prior art, the present application provides a traditional Chinese medicine composition for treating neurasthenia and insomnia and amnesia, its preparation method and application. It has a very good therapeutic effect on neurasthenia and insomnia and amnesia, and has no any toxic and side effects, nor any drug dependence.

[0011] The present invention is implemented by adopting the following technical solutions:

[0012] On the one hand, the present invention provides a series of traditional Chinese medicine compositions of Bu Jue Xiao for neurasthenia and insomnia and amnesia. The composition is made from the following raw materials in parts by weight:

[0013] 1200 - 2500 parts of Ganoderma lucidum, 1100 - 2550 parts of Astragalus membranaceus, 20 - 70 parts of starch, 5 - 50 parts of granulated sugar, 1 - 15 parts of magnesium stearate.

[0014] Preferably, the composition is made from the following raw materials in parts by weight:

[0015] 1635 - 2170 parts of Ganoderma lucidum, 1810 - 2220 parts of Astragalus membranaceus, 30 - 50 parts of starch, 10 - 30 parts of granulated sugar, 3 - 10 parts of magnesium stearate.

[0016] More preferably, the composition is made from the following raw materials in parts by weight:

[0017] 1800 - 2000 parts of Ganoderma lucidum, 1900 - 2100 parts of Astragalus membranaceus, 35 - 45 parts of starch, 15 - 25 parts of granulated sugar, 5 - 8 parts of magnesium stearate.

[0018] Most preferably, the composition is made from the following raw materials in parts by weight:

[0019] 1900 parts of Ganoderma lucidum, 2020 parts of Astragalus membranaceus, 40 parts of starch, 20 parts of granulated sugar, 6 parts of magnesium stearate.

[0020] Preferably, the composition is a tablet. Preferably, the content of ganoderma polysaccharide in the composition is not less than 0.8% (m / m), the content of triterpenoids and sterols is not less than 2.0% (m / m), the content of astragaloside IV is not less than 3.0% (m / m), and the content of calycosin-7-O-β-D-glucoside is not less than 2.0% (m / m);

[0021] Preferably, the content of ganoderma polysaccharide in the composition is not less than 2.16% (m / m), the content of triterpenoids and sterols is not less than 5.93% (m / m), the content of astragaloside IV is not less than 4.12% (m / m), and the content of calycosin-7-O-β-D-glucoside is not less than 3.24% (m / m);

[0022] Preferably, the content of ganoderma polysaccharide in the composition is not less than 3.01% (m / m), the content of triterpenoids and sterols is not less than 7.84% (m / m), the content of astragaloside IV is not less than 5.44% (m / m), and the content of calycosin-7-O-β-D-glucoside is not less than 4.57% (m / m);

[0023] Preferably, the content of ganoderma polysaccharide in the composition is 2.16% - 3.42% (m / m), the content of triterpenoids and sterols is 5.93% - 8.27% (m / m), the content of astragaloside IV is 4.12% - 10.27% (m / m), and the content of calycosin-7-O-β-D-glucoside is 3.24% - 7.58% (m / m);

[0024] Preferably, the content of ganoderma polysaccharide in the composition is 3.01% - 3.42% (m / m), the content of triterpenoids and sterols is 7.84% - 8.27% (m / m), the content of astragaloside IV is 5.44% - 10.27% (m / m), and the content of calycosin-7-O-β-D-glucoside is 4.57% - 7.58% (m / m);

[0025] More preferably, the content of ganoderma polysaccharide in the composition is 3.42% (m / m), the content of triterpenoids and sterols is 8.27% (m / m), the content of astragaloside IV is 10.27% (m / m), and the content of calycosin-7-O-β-D-glucoside is 7.58% (m / m).

[0026] On the other hand, the present invention provides a method for preparing the above traditional Chinese medicine composition, which comprises the following steps:

[0027] Add ganoderma paste powder, astragalus paste powder, starch, and granulated sugar into a mixer for dry mixing. After the mixing is completed, add an organic solvent for wet mixing to obtain the composition.

[0028] Preferably, the time for dry mixing is 15 - 40 minutes, preferably 20 minutes.

[0029] Preferably, the time for wet mixing is 3 - 30 minutes, preferably 5 - 10 minutes.

[0030] Preferably, the organic solvent is ethanol, preferably 85% (v / v) ethanol.

[0031] In a preferred embodiment, the preparation method of the traditional Chinese medicine composition of the present invention is as follows:

[0032] Mixing: Add the prepared Ganoderma lucidum paste powder, Astragalus membranaceus paste powder, starch, and granulated sugar into a trough-type mixer, turn on the stirring, and dry mix for 20 minutes. After the mixing is completed, let it stand for 5 minutes, then open the container lid of the trough-type mixer and add 900 g of 85% (v / v) ethanol. After all is added, tightly cover the container lid, turn on the stirring, and wet mix for 5 - 10 minutes to make a suitable uniform soft material that can form a ball when held in the hand and disperse when lightly pressed, for preparing granulation.

[0033] Tablets are obtained after granulation, drying, sizing, total mixing, and tableting.

[0034] In a particularly preferred embodiment, the preparation method of the traditional Chinese medicine composition of the present invention is as follows:

[0035] Mixing: Add Ganoderma lucidum paste powder, Astragalus membranaceus paste powder, starch, and granulated sugar into a trough-type mixer, turn on the stirring, and dry mix for 20 minutes. After the mixing is completed, let it stand for 5 minutes, then open the container lid of the trough-type mixer and add 85% (v / v) ethanol. After all is added, tightly cover the container lid, turn on the stirring, and wet mix for 5 - 10 minutes to make a suitable uniform soft material that can form a ball when held in the hand and disperse when lightly pressed, for preparing granulation.

[0036] Granulation: After the wet mixing is completed, transfer the soft material to a LYK-160 swing granulator with a stainless steel basin for granulation, and the mesh number of the sieve is 20 meshes.

[0037] Drying: Spread the prepared wet granules evenly on the material tray of a hot air circulation oven. The thickness of the wet granules shall not exceed two-thirds of the material tray, and then dry them. The drying temperature is 65 ± 5 °C, and the drying time is 90 minutes. The moisture content of the dried granules shall not exceed 2.0 - 5.0%. Put the dried granules into a clean turnover barrel with an inner lining bag for standby.

[0038] Sizing: Put the dried granules into a swing granulator for sizing, and the mesh number of the sieve is 18 meshes.

[0039] Total mixing: Put the sized granules and magnesium stearate into a three-dimensional motion mixer for mixing. The mixing time is set to 30 minutes, and the rotation speed is 30 revolutions per minute.

[0040] Tableting: Add the qualified granules into the hopper, start the tableting machine for tableting, and the weight difference of the tablets is ±4.5%.

[0041] Preferably, the preparation method of the Ganoderma lucidum paste powder is as follows:

[0042] Weigh Ganoderma lucidum and crush it to a particle size of Φ15 - 25 mm (preferably Φ22 mm) using a crusher. After crushing, put it into an extraction device with a double - layer movable sieve, and inject 5 - 8 times the amount of hot water (water temperature is 85℃ - 100℃) of Ganoderma lucidum. Let the medicinal materials be extracted in the extraction device with the double - layer movable sieve. During the extraction, move the double - layer movable sieve once every half hour, so that the medicinal materials are squeezed and then released between the double - layer movable sieve, filtered, the filtrate is concentrated and dried to obtain the product.

[0043] Preferably, moving the double - layer movable sieve once every half hour during the extraction means moving the double - layer movable sieve up and down in the order from the bottom, middle to the top of the extraction device. For example, if the extraction time is 2 hours, the medicinal materials are placed at the bottom of the extraction device for extraction from 0 - 0.5 hours, at the middle of the extraction device for extraction from 0.5 - 1.0 hours, at the top of the extraction device for extraction from 1.0 - 1.5 hours, and then placed at the bottom of the extraction device for extraction from 1.5 - 2.0 hours.

[0044] Preferably, the extraction can be repeated multiple times, for example, 2 times. If it is multiple extractions, the filtrates are combined and then concentrated.

[0045] Preferably, the temperature of the concentration is 70 - 75℃ (in the preparation of Ganoderma lucidum paste powder).

[0046] Preferably, the concentration means concentrating the filtrate to a relative density of 1.25 ± 0.05 at 70℃ (in the preparation of Ganoderma lucidum paste powder).

[0047] Preferably, the drying means drying using double - layer stainless - steel thin sheets under vacuum and reduced pressure conditions (in the preparation of Ganoderma lucidum paste powder).

[0048] Preferably, the vacuum degree of the drying is - 0.06~ - 0.08 Mpa (in the preparation of Ganoderma lucidum paste powder).

[0049] In a preferred embodiment, the preparation method of the Ganoderma lucidum paste powder is as follows:

[0050] Extraction: Weigh Ganoderma lucidum and crush it to a particle size of Φ15 - 25 mm using a crusher. After crushing, put the Ganoderma lucidum into an extraction tank with a double-layer movable screen, and carry out extraction of the medicinal materials in the double-layer screen. Inject 5 - 8 times the amount of hot water (water temperature is 85°C - 100°C) of the Ganoderma lucidum into the extraction tank. During extraction, move the screen up and down every half hour to squeeze and release the medicinal materials in the middle of the screen, and repeat the operation 3 times. In the first 0.5 hour, the medicinal materials are placed at the bottom of the extraction tank for extraction, from 0.5 - 1.0 hour, the medicinal materials are placed in the middle of the extraction tank for extraction, from 1.0 - 1.5 hour, the medicinal materials are placed above the extraction liquid for extraction, and from 1.5 - 2.0 hour, they are placed at the bottom of the extraction tank again for extraction. The total extraction time is 2 hours. The medicinal liquid is filtered through a 100-mesh internal screen, and the remaining medicinal residues are injected with 5 - 8 times the amount of hot water (water temperature is 85°C - 100°C) of the Ganoderma lucidum medicinal materials and extracted again for 2 hours. The remaining operation steps are the same as those of the first extraction.

[0051] Concentration: Combine the filtrates and transfer them to a concentration tank, control the concentration temperature at 70 - 75°C, and concentrate to a relative density of 1.25 ± 0.05 (70°C) to obtain the Ganoderma lucidum extract.

[0052] Drying: Place the Ganoderma lucidum extract in the material tray of a vacuum drying oven. The thickness shall not exceed two-thirds of the material tray. Place double-layer stainless steel thin sheets in the middle, set the drying temperature at 55 ± 5°C, dry for 3 hours, and the vacuum degree is -0.06 to -0.08 Mpa. The moisture content of the dried paste powder does not exceed 3.0%.

[0053] Preferably, the preparation method of the Astragalus membranaceus paste powder is as follows:

[0054] Weigh Astragalus membranaceus, add a surfactant, inject acid water, stir, evacuate, pressurize, extract, filter the medicinal liquid, add alkaline water to the remaining medicinal residues, stir, pressurize, extract, filter, combine the filtrates and concentrate, and dry to obtain it.

[0055] Preferably, the surfactant is selected from one or more of polyethylene glycol, Tween 20, Tween 60, Tween 80, cetyltrimethylammonium bromide, preferably selected from one or more of Tween 20, Tween 60, Tween 80, more preferably a mixture of Tween 80 and Tween 60, and most preferably a mixture of Tween 60 and Tween 80 with a volume ratio of 1:2.

[0056] Preferably, the acid water includes but is not limited to hydrochloric acid aqueous solution, sulfuric acid aqueous solution, phosphoric acid aqueous solution, citric acid aqueous solution, and is preferably phosphoric acid aqueous solution.

[0057] Preferably, the acid water refers to a pH value of 4 - 6, preferably 5 - 6, and more preferably 5.

[0058] Preferably, the alkaline water includes, but is not limited to, sodium hydroxide solution, potassium hydroxide solution, calcium hydroxide solution, ammonia water, carbonate solution, phosphate solution, and is preferably an aqueous sodium hydroxide solution.

[0059] Preferably, the alkaline water refers to water with a pH value of 8 - 11, preferably 8 - 10, and more preferably 10.

[0060] Preferably, after injecting the acid water and before adding the alkaline water, the pressure is 300 - 450 MPa, preferably 350 MPa.

[0061] Preferably, after injecting the acid water and before adding the alkaline water, the extraction time is 30 - 45 min, preferably 35 min.

[0062] Preferably, the concentration temperature is 55 - 65 °C (in the preparation of astragalus paste powder).

[0063] Preferably, the concentration means concentrating the filtrate to a relative density of 1.25 - 1.30 at 60 °C (in the preparation of astragalus paste powder).

[0064] Preferably, the drying is carried out using double - layer stainless - steel thin sheets under vacuum and reduced pressure conditions (in the preparation of astragalus paste powder).

[0065] Preferably, the vacuum degree of the drying is - 0.06 to - 0.08 Mpa (in the preparation of astragalus paste powder).

[0066] In a specific embodiment, the method for preparing the astragalus paste powder is as follows:

[0067] Extraction: Weigh the sliced astragalus, put the astragalus into a multi - functional extraction tank, add 60 g of Tween (Tween 60: Tween 80 = 1:2), inject 8 times the amount of acid water (pH = 5) of astragalus into the multi - functional extraction tank, set the stirring speed to 30 r / min, evacuate, pressurize to 350 MPa, extract for 35 min, filter the liquid medicine through an 80 - mesh sieve inside, add 6 times the amount of alkaline water (pH = 10) of astragalus to the remaining medicinal residues, set the stirring speed to 50 r / min, pressurize to 350 MPa, extract for 35 min, filter the liquid medicine through an 80 - mesh sieve filter inside, and transfer it to a storage tank for standby.

[0068] Concentration: Concentrate the combined extracted liquid medicine, control the temperature at 60 ± 5 °C, and concentrate it to an extract with a relative density of 1.25 - 1.30 (measured at 60 °C).

[0069] Drying: Place the astragalus extract in the material tray of a vacuum and reduced - pressure drying oven, the thickness shall not exceed two - thirds of the material tray, place double - layer stainless - steel thin sheets in the middle, set the drying temperature at 55 ± 5 °C, dry for 3 hours, the vacuum degree is - 0.06 to - 0.08 Mpa, and the moisture content of the dried paste powder does not exceed 3.0%.

[0070] Astragalus membranaceus is rich in saponins (mainly astragaloside I and II) and flavonoids (mainly formononetin and calycosin), and also contains components such as amino acids and betaine. It has a variety of pharmacological effects: it can promote body metabolism and anti-fatigue, and accelerate the renewal of serum and liver proteins; it shows obvious diuretic effects and helps to eliminate urinary protein in experimental nephritis; and it can improve the symptoms of anemic animals. In cell culture experiments, Astragalus membranaceus can significantly increase the number of cells, promote the vigorous growth of cells and extend the cell lifespan. In addition, Astragalus membranaceus can enhance myocardial contractility, protect the cardiovascular system, has the effects of anti-arrhythmia, dilating coronary arteries and peripheral blood vessels, reducing blood pressure, and can reduce platelet adhesiveness, thus reducing thrombus formation to a certain extent. It also has the effects of reducing blood lipid, anti-aging, anti-hypoxia, anti-radiation and protecting the liver.

[0071] Ganoderma lucidum contains rich chemical components such as polysaccharides, nucleosides, furans, sterols, alkaloids, triterpenoids, oils, various amino acids and proteins, enzymes, organic germanium and various trace elements. Among them, the main ones are ganoderic acid, adenosine, ganoderma spore inner ester A, ganoderma spore acid A, ganoderma alkaloid A, ganoderma alkaloid B, adenosine monophosphate and adenine, etc.

[0072] In this application, Astragalus membranaceus is used as the monarch drug, and its main effects include invigorating qi and ascending yang, consolidating the exterior and stopping sweating, promoting diuresis and alleviating edema, promoting the production of body fluid and nourishing blood, activating qi and dredging collaterals, expelling pus by supporting healthy qi, and promoting granulation for sore healing. While Ganoderma lucidum is used as the minister drug, and its main function is to replenish qi and soothe the nerves, relieve cough and asthma. The prescription composed of these two drugs together exerts the efficacy of relieving symptoms such as neurasthenia, insomnia and amnesia, loss of appetite, general fatigue and shortness of breath with excessive sweating.

[0073] In this application, when extracting Ganoderma lucidum paste powder, the crushing diameter of Ganoderma lucidum is controlled at 22 mm, and the extract yield can reach 8.41%, which is 6.3 times higher than that of uncrushed Ganoderma lucidum. The double-layer lifting device is used for extraction, so that the medicinal materials are fully extracted at different parts of the extraction tank. At the same time, the extraction and extrusion combination method is used to release the extracted substances, avoiding the influence of supersaturation state on the drug extraction effect. The medicinal materials are extruded and released 3 times in the middle of the sieve mesh. The medicinal materials are placed at the bottom of the extraction tank for extraction in the first 0.5 hours, in the middle of the extraction tank for extraction from 0.5 to 1.0 hours, in the upper part of the extract for extraction from 1.0 to 1.5 hours, and then placed at the bottom of the extraction tank for extraction from 1.5 to 2.0 hours, so that the extraction rate of Ganoderma lucidum extract is increased to 12.59%, and the utilization rate of the medicinal materials is increased by 49.7% again, achieving a high utilization rate of the medicinal materials and improving the therapeutic effect of the drugs in this application. At the same time, a vacuum drying oven is selected for drying, and double-layer stainless steel thin sheets are placed in the middle for drying, which saves 4 times the drying time compared with the hot air circulation oven drying, improves the drying efficiency and reduces the industrial production cost.

[0074] The Astragalus membranaceus paste powder is extracted by combining high-pressure assisted extraction with semi-bionic extraction (acid water extraction, alkaline water extraction). When the pressure is controlled at 300 Mpa, the pH of the acid water is 5, the pH of the alkaline water is 10, and the extraction time is 35 minutes, the extraction rate of the prepared extract is as high as 13.82%. At the same time, a surfactant is added during extraction (for example, Tween 60: Tween 80 = 1:2), so that the extraction rate of the extract reaches 16.82%. Compared with the water extraction method (3.22%), the extraction rate of the Astragalus membranaceus extract is increased by 5.2 times, the content of astragaloside IV is increased by 6.7 times, and the content of calycosin-7-O-β-D-glucoside is increased by 5.5 times, effectively improving the bioavailability of Astragalus membranaceus medicinal materials. At the same time, compared with the traditional water extraction method, the extraction time is shortened by 290 minutes, reducing 80.6% of the original extraction time, obviously reducing the industrial production cost, increasing the content of effective drug components, and improving the therapeutic efficiency of the drug.

[0075] When preparing the drug of this application, a mixed solvent is preferably used. When the solvent is 85% (v / v) ethanol, the prepared tablets are the most ideal. There are no abnormal tablets in terms of weight difference and friability, and the hardness is moderate and meets the standard requirements, avoiding waste of raw materials such as broken pieces and residual pieces, and reducing the production cost. At the same time, its dissolution rate is 92% at 30 minutes, that is, neither the dissolution rate is too fast nor too slow, which can ensure the accurate release of the drug, and a large amount of dissolved substances are just completely released in the gastrointestinal tract, reaching the best release time of the drug during the treatment of diseases, enabling the drug to be efficiently output and allowing patients to feel the therapeutic effect of the drug as soon as possible.

[0076] The drug preparation of this application is prepared by using an efficient Ganoderma lucidum paste powder extraction method, Astragalus membranaceus paste powder extraction method, and a highly applicable preparation method. The content of Ganoderma lucidum polysaccharide in the drug preparation is increased to 3.42% (m / m), the content of triterpenoids and sterols is increased to 8.27%, the content of astragaloside IV is increased to 10.27% (m / m), and the content of calycosin-7-O-β-D-glucoside is increased to 7.58% (m / m). Compared with the traditional water extraction method, the extraction rates of the effective components are greatly improved. Among them, the content of Ganoderma lucidum polysaccharide is increased by 1.5 times, the content of triterpenoids and sterols is increased by 1.4 times, the content of astragaloside IV is increased by 6.7 times, and the content of calycosin-7-O-β-D-glucoside is increased by 5.5 times. At the same time, high-quality tablets are prepared by using a highly adaptable mixed solvent. Under the condition of meeting the basic requirements of tablets, the production of inferior tablets is greatly reduced, the quality of tablets is improved, and the production cost is reduced. Also, the dissolution effect is controlled to the best, reaching the most effective release time for treatment, significantly improving the cure rate of patients with neurasthenia and insomnia and forgetfulness. Among them, the therapeutic efficiency is as high as 95%, and the cure rate is as high as 45%. Detailed implementation mode

[0077] The present invention will be further described below in conjunction with specific embodiments, but the embodiments do not impose any form of limitation on the present invention. Unless otherwise specified, the reagents, methods, and equipment used in the present invention are conventional reagents, methods, and equipment in the technical field. Unless otherwise specified, the reagents and materials used in the present invention are commercially available.

[0078] Example 1: Preparation of Ganoderma lucidum paste powder

[0079] Extraction: Weigh 950 g of Ganoderma lucidum, and crush it to a particle size of Φ22 mm using a crusher. After crushing the Ganoderma lucidum, put it into an extraction tank with a double-layer movable sieve mesh, and let the medicinal materials be extracted in the double-layer sieve mesh. Inject 6 times the amount of hot water (water temperature is 85°C - 100°C) of Ganoderma lucidum into the extraction tank. During the extraction, move the sieve mesh up and down every half hour to make the medicinal materials be squeezed and released in the middle of the sieve mesh, and repeat the operation 3 times. In the first 0.5 hour, the medicinal materials are placed at the bottom of the extraction tank for extraction, from 0.5 - 1.0 hour, the medicinal materials are placed in the middle of the extraction tank for extraction, from 1.0 - 1.5 hour, the medicinal materials are placed above the extraction liquid for extraction, and from 1.5 - 2.0 hour, they are placed at the bottom of the extraction tank again for extraction. The total extraction time is 2 hours. The medicinal liquid is filtered through a filter with a 100-mesh sieve mesh. The remaining medicinal residues are injected with 6 times the amount of hot water (water temperature is 85°C - 100°C) of Ganoderma lucidum medicinal materials, and extracted again for 2 hours. The remaining operation steps are the same as those of the first extraction.

[0080] Concentration: Combine the filtrates and transfer them to a concentration tank, control the concentration temperature at 70 - 75°C, and concentrate to an extract with a relative density of 1.20 - 1.30 (measured at 70°C) to obtain Ganoderma lucidum extract.

[0081] Drying: Place the Ganoderma lucidum extract in the material tray of a vacuum decompression drying oven, with the thickness not exceeding two-thirds of the material tray. Place double-layer stainless steel thin sheets in the middle, set the drying temperature at 55 ± 5°C, dry for 3 hours, with a vacuum degree of -0.06 - -0.08 MPa. After drying, the moisture content of the paste powder does not exceed 3.0%.

[0082] Example 2: Preparation of Astragalus membranaceus paste powder

[0083] Extraction: Weigh 1010 g of sliced Astragalus membranaceus, put the Astragalus membranaceus into a multi-functional extraction tank, add 60 g of Tween (Tween 60: Tween 80 = 1:2), inject 8 times the amount of acid water (pH is 5) of Astragalus membranaceus into the multi-functional extraction tank, set the stirring speed at 30 r / min, evacuate, and pressurize to 350 MPa, extract for 35 min. The medicinal liquid is filtered through a filter with an 80-mesh sieve mesh. The remaining medicinal residues are added with 6 times the amount of alkaline water (pH is 10) of Astragalus membranaceus, set the stirring speed at 50 r / min, pressurize to 350 MPa, extract for 35 min. The medicinal liquid is filtered through a filter with an 80-mesh sieve mesh and transferred to a storage tank for standby.

[0084] Concentration: Concentrate the combined extracted liquid of the herbs, controlling the temperature at 60 ± 5°C until an extract with a relative density of 1.25 - 1.30 (measured at 60°C) is obtained.

[0085] Drying: Place the astragalus extract in the material tray of a vacuum drying oven. The thickness should not exceed two-thirds of the material tray. Place double-layer stainless steel thin sheets in the middle. Set the drying temperature at 55 ± 5°C and dry for 3 hours. The vacuum degree is -0.06 to -0.08 MPa. The moisture content of the dried paste powder should not exceed 3.0%.

[0086] Example 3: Preparation of the unconscious series of traditional Chinese medicine compositions of the present invention

[0087] Prescription amount: Ganoderma lucidum 950 g, astragalus membranaceus 1010 g, starch 20 parts, granulated sugar 10 parts, magnesium stearate 3 parts.

[0088] Obtain Ganoderma lucidum paste powder and astragalus membranaceus paste powder according to the preparation methods of Example 1 and Example 2.

[0089] Mixing: Add the prepared Ganoderma lucidum paste powder, astragalus membranaceus paste powder, starch, and granulated sugar into a trough-type mixer. Start stirring and dry mix for 20 minutes. After mixing, let it stand for 5 minutes, then open the container lid of the trough-type mixer and add 900 g of 85% (v / v) ethanol. After all is added, cover the container lid tightly, start stirring, and wet mix for 5 - 10 minutes to make a suitable uniform soft material that can form a ball when held in the hand and break up easily when lightly pressed, for granulation preparation.

[0090] Granulation: After the wet mixing is completed, transfer the soft material to a LYK-160 swing granulator with a stainless steel basin for granulation, and the mesh number of the sieve is 20 meshes.

[0091] Drying: Evenly spread the prepared wet granules on the material tray of a hot air circulation oven. The thickness of the wet granules should not exceed two-thirds of the material tray and dry. The drying temperature is 65 ± 5°C, and the drying time is 90 minutes. The moisture content of the dried granules should not exceed 2.0 - 5.0%. Put the dried granules into a turnover barrel for standby.

[0092] Screening: Place the dried granules in a swing granulator for screening, and the mesh number of the sieve is 18 meshes.

[0093] Total mixing: Put the screened granules and magnesium stearate into a three-dimensional motion mixer, cover the feeding cover, and mix. Set the mixing time to 30 minutes and the rotation speed to 30 revolutions per minute.

[0094] Tablet pressing: Add the qualified granules into the hopper, start the tablet press for tablet pressing, and the tablet weight difference is ±4.5%.

[0095] Experimental example 1: Influence of different crushing particle sizes on the extraction rate of Ganoderma lucidum

[0096] The Ganoderma lucidum medicinal material has an umbrella-like structure. The umbrella body is thick and large in volume, making it difficult to extract. To compare the influence of different crushing degrees on the extraction rate of the extract, it will be studied according to the following crushing scheme to find the optimal crushing particle size suitable for this extraction method. The detection results of the extracts corresponding to different particle sizes are shown in Table 1 below.

[0097] Extraction method: Weigh 950 g of Ganoderma lucidum, crush it to the specified particle size using a crusher, add 6 times the amount of water of the medicinal material, extract for 3 hours for the first time, filter the medicinal liquid through a 100-mesh sieve inside, add 6 times the amount of water of the medicinal material to the remaining medicinal residues, extract for 3 hours for the second time, filter, combine the filtrates and transfer them to a concentration tank, control the concentration temperature at 70 - 75 °C, and concentrate to a relative density of 1.25 ± 0.05 (70 °C) to obtain the Ganoderma lucidum extract.

[0098] Table 1 Detection results of the influence of different crushing particle sizes of Ganoderma lucidum on the Ganoderma lucidum extract

[0099]

[0100] Conclusion: The extraction experiments of different crushing particle sizes of the above Ganoderma lucidum show that when the crushing diameter range is 15 mm - 25 mm, the extraction effects are close. Compared with other crushing particle sizes, the contents of each extract are significantly improved. Among them, when the crushing particle size diameter is 22 mm, the extraction effect is the best, and the extract extraction rate can reach 8.41%, which is 6.3 times higher than the extraction rate of uncrushed Ganoderma lucidum. It is not that the smaller the crushing particle size, the better the extraction effect. Confirming the optimal crushing particle size can effectively improve the extraction rate of the Ganoderma lucidum extract, while increasing the contents of effective components such as Ganoderma lucidum polysaccharide, triterpenoids, and sterols, and improving the utilization rate of the medicinal material.

[0101] Experimental Example 2: Influence of the extraction method on the Ganoderma lucidum extract

[0102] The yield of the Ganoderma lucidum extract obtained by the traditional water extraction method is extremely low, and the effective components cannot be fully extracted, wasting the medicinal material and increasing the production cost of the medicine. To improve the disadvantage of incomplete extraction in the extraction process, the process is improved according to the following extraction method to achieve a better extraction effect.

[0103] Extraction method 1: Weigh 950 g of Ganoderma lucidum, crush it using a crusher (Φ22 mm), add 6 times the amount of water of the medicinal material, extract for 3 hours for the first time, filter the medicinal liquid through a 100-mesh sieve inside, add 6 times the amount of water of the medicinal material to the remaining medicinal residues, extract for 3 hours for the second time, filter, combine the filtrates and transfer them to a concentration tank, control the concentration temperature at 70 - 75 °C, and concentrate to a relative density of 1.25 ± 0.05 (70 °C) to obtain the Ganoderma lucidum extract.

[0104] Extraction method 2: Weigh 950 g of Ganoderma lucidum, crush it with a crusher (Φ22 mm), add 6 times the amount of hot water of the medicinal materials, extract for 3 hours for the first time, filter the medicinal liquid through a 100-mesh sieve inside, add 6 times the amount of water of the medicinal materials to the remaining medicinal residues, extract for 3 hours for the second time, filter, combine the filtrates and transfer them to a concentration tank, control the concentration temperature at 70 - 75 °C, and concentrate to a relative density of 1.25 ± 0.05 (70 °C) to obtain the Ganoderma lucidum extract.

[0105] Extraction method 3: Weigh 950 g of Ganoderma lucidum, crush it with a crusher (Φ22 mm), add 6 times the amount of hot water of the medicinal materials, extract for 4 hours for the first time, filter the medicinal liquid through a 100-mesh sieve inside, add 6 times the amount of hot water of the medicinal materials to the remaining medicinal residues, extract for 4 hours for the second time, filter, combine the filtrates and transfer them to a concentration tank, control the concentration temperature at 70 - 75 °C, and concentrate to a relative density of 1.25 ± 0.05 (70 °C) to obtain the Ganoderma lucidum extract.

[0106] Extraction method 4: Weigh 950 g of Ganoderma lucidum, crush it with a crusher (Φ22 mm), put the crushed Ganoderma lucidum into an extraction tank with a double-layer movable sieve, and perform extraction of the medicinal materials in the double-layer sieve. Inject 6 times the amount of hot water of Ganoderma lucidum into the extraction tank respectively. Move the sieve up and down once every half hour during extraction to make the medicinal materials be squeezed and released in the middle of the sieve, and operate repeatedly 3 times. Place the medicinal materials at the bottom of the extraction tank for extraction in the first 0.5 hour, at the middle of the extraction tank for extraction from 0.5 to 1.0 hour, at the upper part of the extraction liquid for extraction from 1.0 to 1.5 hours, and at the bottom of the extraction tank for extraction from 1.5 to 2.0 hours. Extract for a total of 2 hours. Filter the medicinal liquid through a 100-mesh sieve inside, inject 6 times the amount of hot water of Ganoderma lucidum medicinal materials into the remaining medicinal residues, extract for another 2 hours, and the remaining operation steps are the same as those in the first extraction. Combine the filtrates and transfer them to a concentration tank, control the concentration temperature at 70 - 75 °C, and concentrate to a relative density of 1.25 ± 0.05 (70 °C) to obtain the Ganoderma lucidum extract.

[0107] Detect the extracts obtained by the above different extraction methods according to the Ganoderma lucidum content determination method in the Chinese Pharmacopoeia (2020 Edition). Among them, the Ganoderma lucidum polysaccharide is calculated as anhydrous glucose and shall not be less than 0.9%, and the triterpenoids and sterols are calculated as oleanolic acid and shall not be less than 0.5%. The detection results are shown in Table 2 below.

[0108] Table 2 Detection results of Ganoderma lucidum extracts obtained by different extraction methods

[0109]

[0110] Conclusion: By changing the above extraction method, the extraction effect of Ganoderma lucidum reaches 1.5 times that of the traditional extraction method. Without changing the essence of the extraction method, unexpected extraction results are obtained. Using a double-layer sieve device and controlling the extraction position, the extraction rate of the extract is increased from 8.41% to 12.59%, while the extraction time is shortened by 4 hours, saving half of the extraction time. While reducing the cost, the utilization rate of medicinal materials is increased by 49.7%, providing more advantages for process production.

[0111] Experimental Example 3: Effect of the amount of extraction solvent on the Ganoderma lucidum extract

[0112] Extraction method: Weigh 950 g of Ganoderma lucidum, crush it with a crusher (Φ22 mm), and put the crushed Ganoderma lucidum into an extraction tank with a double-layer movable sieve to extract the medicinal materials in the double-layer sieve. Inject 8 times the amount of hot water of Ganoderma lucidum into the extraction tank. During the extraction, move the sieve up and down every half hour to make the medicinal materials squeeze and release in the middle of the sieve, and repeat the operation 3 times. In the first 0.5 hour, the medicinal materials are placed at the bottom of the extraction tank for extraction. From 0.5 to 1.0 hour, the medicinal materials are placed in the middle of the extraction tank for extraction. From 1.0 to 1.5 hours, the medicinal materials are placed above the extraction liquid for extraction. From 1.5 to 2.0 hours, they are placed at the bottom of the extraction tank again for extraction. The total extraction time is 2 hours. The medicinal liquid is filtered through a 100-mesh sieve inside. The remaining medicinal residues are injected with 8 times the amount of hot water of Ganoderma lucidum medicinal materials and extracted again for 2 hours. The rest of the operation steps are the same as the first extraction. Combine the filtrates and transfer them to a concentration tank, control the concentration temperature at 70 - 75 °C, and concentrate to a relative density of 1.25 ± 0.05 (70 °C) to obtain the Ganoderma lucidum extract.

[0113] Perform the extraction multiple times according to the above extraction method, only changing the solvent dosage during the two extractions to 4 times, 5 times, 6 times, 7 times, 8 times, 9 times, and 10 times the amount of water of Ganoderma lucidum medicinal materials respectively, and the rest of the parameters and steps are the same.

[0114] Detect the extracts obtained by the above different extraction methods according to the Ganoderma lucidum content determination method in the Chinese Pharmacopoeia (2020 Edition). Among them, the polysaccharides of Ganoderma lucidum are calculated as anhydrous glucose and shall not be less than 0.9%, and the triterpenoids and sterols are calculated as oleanolic acid and shall not be less than 0.5%. The detection results are shown in Table 3 below.

[0115] Table 3 Detection results of Ganoderma lucidum extracts obtained with different amounts of extraction solvents

[0116]

[0117] Conclusion: According to the above experimental results, when the amount of the extraction solvent for Ganoderma lucidum is 5 - 8 times, the extraction rates of the extracts are similar, and all can extract the active ingredients in Ganoderma lucidum medicinal materials sufficiently. Therefore, 5 - 8 times the amount of the extraction solvent is selected as the extraction solvent amount for Ganoderma lucidum.

[0118] Experimental Example 4: Effect of the drying method on the Ganoderma lucidum extract

[0119] There are various drying methods for medicinal material extracts and the drying equipment used. The seemingly simple drying process has a crucial impact on product quality. The optimal drying equipment and drying conditions are key steps affecting the extraction efficiency. Now, the drying methods for Ganoderma lucidum are screened and optimized, and the specific drying methods are as follows.

[0120] Drying method 1: Place the Ganoderma lucidum extract paste in the material tray of a vacuum drying oven. The thickness should not exceed two-thirds of the material tray. Set the drying temperature at 55 ± 5°C and dry for 8 hours. The vacuum degree is -0.06 to -0.08 MPa. The moisture content of the dried paste powder does not exceed 3.0%.

[0121] Drying method 2: Place the Ganoderma lucidum extract paste in the material tray of a hot air circulation oven. The thickness should not exceed two-thirds of the material tray. Set the drying temperature at 55 ± 5°C and dry for 12 hours. The moisture content of the dried paste powder does not exceed 5.0%.

[0122] Drying method 3: Place the Ganoderma lucidum extract paste in the material tray of a hot air circulation oven. The thickness should not exceed two-thirds of the material tray. Place two layers of stainless steel sheets in the middle. Set the drying temperature at 55 ± 5°C and dry for 8 hours. The moisture content of the dried paste powder does not exceed 3.0%.

[0123] Drying method 4: Place the Ganoderma lucidum extract paste in the material tray of a vacuum drying oven. The thickness should not exceed two-thirds of the material tray. Place two layers of stainless steel sheets in the middle. Set the drying temperature at 55 ± 5°C and dry for 3 hours. The vacuum degree is -0.06 to -0.08 Mpa. The moisture content of the dried paste powder does not exceed 3.0%.

[0124] Detect the extracts obtained by the above different drying methods according to the Ganoderma lucidum content determination method in the Chinese Pharmacopoeia (2020 Edition). The detection results are shown in Table 4 below.

[0125] Table 4 Detection results of Ganoderma lucidum extracts obtained by different drying methods

[0126]

[0127] Conclusion: The above experimental results show that different drying equipment and drying methods have a great impact on the contents of Ganoderma lucidum polysaccharides, triterpenoids, and sterols. Drying with a vacuum drying oven has a better effect on retaining active ingredients than drying with a hot air circulation oven. Drying with two layers of stainless steel sheets reduces the drying time by 66.7%, from 8.25 hours to 2.75 hours. It effectively shortens the drying process time and reduces the time and energy consumption costs for industrial production.

[0128] Experimental example 5: Influence of extraction method on Astragalus membranaceus extract

[0129] The extract yield of Astragalus membranaceus obtained by the traditional water extraction method is relatively low, and a part of it will be lost during digestion and absorption in the human body. Therefore, the semi-bionic extraction method can effectively improve the extraction efficiency of Astragalus membranaceus extract and reduce the loss of active ingredients. At the same time, combined with the high-pressure extraction method, the extraction effect is greatly improved. The specific experimental methods and steps are as follows. The test results are shown in Table 5 below.

[0130] Extraction method 1: Weigh 1010 g of sliced Astragalus membranaceus, add 8 times the amount of water of the Astragalus membranaceus medicinal material, extract for 3 hours for the first time, filter the medicinal liquid through an 80-mesh sieve inside, add 6 times the amount of water of the medicinal material to the remaining medicinal residues, extract for 3 hours for the second time, filter, combine the filtrates and transfer them to a concentration tank, control the temperature at 60 ± 5 °C, the vacuum degree at -0.06 to -0.08 Mpa, and concentrate to an extract with a relative density of 1.25 - 1.30 (measured at 60 °C) to obtain the Astragalus membranaceus extract.

[0131] Extraction method 2: Weigh 1010 g of sliced Astragalus membranaceus, put the Astragalus membranaceus into a multi-functional extraction tank, inject 8 times the amount of water of the Astragalus membranaceus into the multi-functional extraction tank, set the stirring speed at 30 r / min, evacuate, pressurize to 300 MPa, extract for 0.5 hour, filter the medicinal liquid through an 80-mesh sieve inside, add 6 times the amount of water of the Astragalus membranaceus to the remaining medicinal residues, set the stirring speed at 50 r / min, pressurize to 300 MPa, extract for 0.5 hour, filter, combine the filtrates and transfer them to a concentration tank, control the temperature at 60 ± 5 °C, the vacuum degree at -0.06 to -0.08 Mpa, and concentrate to an extract with a relative density of 1.25 - 1.30 (measured at 60 °C) to obtain the Astragalus membranaceus extract.

[0132] Extraction method 3: Weigh 1010 g of sliced Astragalus membranaceus, put the Astragalus membranaceus into a multi-functional extraction tank, inject 8 times the amount of acid water of the Astragalus membranaceus into the multi-functional extraction tank, set the stirring speed at 30 r / min, extract for 0.5 hour, filter the medicinal liquid through an 80-mesh sieve inside, add 6 times the amount of alkaline water of the Astragalus membranaceus to the remaining medicinal residues, set the stirring speed at 50 r / min, extract for 0.5 hour, filter, combine the filtrates and transfer them to a concentration tank, control the temperature at 60 ± 5 °C, the vacuum degree at -0.06 to -0.08 Mpa, and concentrate to an extract with a relative density of 1.25 - 1.30 (measured at 60 °C) to obtain the Astragalus membranaceus extract.

[0133] Extraction method 4: Weigh 1010 g of sliced astragalus membranaceus, put the astragalus membranaceus into a multi-functional extraction tank, inject 8 times the amount of acid water of astragalus membranaceus into the multi-functional extraction tank, set the stirring speed to 30 r / min, evacuate, pressurize to 300 MPa, extract for 0.5 hours, filter the liquid medicine through an 80-mesh sieve inside, add 6 times the amount of alkaline water of astragalus membranaceus to the remaining medicinal residues, set the stirring speed to 50 r / min, pressurize to 300 MPa, extract for 0.5 hours, filter, combine the filtrates and transfer them to a concentration tank, control the temperature at 60 ± 5 °C, and the vacuum degree at -0.06 to -0.08 Mpa, concentrate to an extract with a relative density of 1.25 to 1.30 (measured at 60 °C), and thus obtain the astragalus membranaceus extract.

[0134] Table 5 Experimental results of the influence of extraction methods on astragalus membranaceus extract

[0135]

[0136] Conclusion: When astragalus membranaceus is extracted with water, the content of astragaloside IV in the obtained extract is 1.54%, and the content of calycosin-7-O-β-D-glucoside is 1.37%. When using high-pressure extraction combined with semi-bionic extraction method (acid water extraction, alkaline water extraction), the content of astragaloside IV is 4.12%, and the content of calycosin-7-O-β-D-glucoside is 3.24%. The content of astragaloside IV increases by 2.7 times, and the content of calycosin-7-O-β-D-glucoside increases by 2.4 times. At the same time, the extraction rate of the extract increases by 5.21%. The extraction time is also reduced from 6 hours to 0.5 hours. It greatly improves the conversion rate of medicinal materials, shortens the extraction time while improving the therapeutic effect of the drug, that is, it can reduce the time cost and improve the extraction rate of the effective components of medicinal materials.

[0137] Experimental example 6: Influence of pH on semi-bionic extraction of astragalus membranaceus

[0138] The semi-bionic extraction method simulates the basic processes of oral administration and gastrointestinal transit, and uses acidic water and alkaline water with selected pH values for extraction. The semi-bionic extraction method can effectively improve the extraction rate of astragalus membranaceus medicinal materials. However, to achieve the best extraction effect, the influence of different pH values on the extraction rate of astragalus membranaceus is now compared, and the comparison is carried out according to the following test methods to determine the optimal extraction pH value. The experimental results are shown in Tables 6 and 7 below.

[0139] Experimental method: Weigh 1010 g of sliced Astragalus membranaceus, put the Astragalus membranaceus into a multi-functional extraction tank, inject 8 times the amount of acid water (pH values are 3, 4, 5, 6 respectively) of Astragalus membranaceus into the multi-functional extraction tank, set the stirring speed to 30 r / min, evacuate, pressurize to 300 MPa, extract for 0.5 hours, filter the medicinal liquid through an 80-mesh sieve inside, add 6 times the amount of alkaline water (pH values are 7.5, 8, 9, 10 respectively) of Astragalus membranaceus to the remaining medicinal residues, set the stirring speed to 50 r / min, pressurize to 300 MPa, extract for 0.5 hours, filter, combine the filtrates and transfer them to a concentration tank, control the temperature at 60 ± 5 °C, the vacuum degree at -0.06 to -0.08 Mpa, and concentrate to an extract with a relative density of 1.25 - 1.30 (measured at 60 °C) to obtain the Astragalus membranaceus extract.

[0140] Table 6 Experimental results of the effect of acid water pH value on the extraction of Astragalus membranaceus

[0141]

[0142] Table 7 Experimental results of the effect of alkaline water pH value on the extraction of Astragalus membranaceus

[0143]

[0144]

[0145] Conclusion: The semi-bionic extraction method effectively improves the extraction rate of the Astragalus membranaceus extract. According to the above experimental results, when acid water with a pH value of 5 is selected for the first extraction, the extraction rate of the extract reaches 10.57%, which is 43.8% higher than that when the pH value is 3. The contents of astragaloside IV and calycosin-7-O-β-D-glucoside increase by 59.2% and 65.7% respectively; when alkaline water with a pH of 10 is selected for the second extraction, the extraction rate is as high as 11.68%, the content of astragaloside IV reaches 5.44%, and the content of calycosin-7-O-β-D-glucoside is as high as 4.57%, which is 3.6 times higher than the extraction rate of the extract by the traditional water extraction method. The contents of astragaloside IV and calycosin-7-O-β-D-glucoside increase by 3.5 times and 3.3 times respectively. This extraction method highly improves the extraction effect of Astragalus membranaceus, greatly improves the utilization rate of medicinal materials, enables the active ingredients of medicinal materials to play their roles fully, and improves the therapeutic effect of traditional Chinese medicine compositions.

[0146] Experimental Example 7: Effects of pressure and extraction time on the high-pressure extraction of Astragalus membranaceus

[0147] To achieve the optimal extraction conditions for the extraction rate of the Astragalus membranaceus extract and avoid the loss of active ingredients due to high-pressure extraction time and pressure, compare the extraction effects of the Astragalus membranaceus extract under different extraction times and different pressures to improve the extraction rate without losing active ingredients.

[0148] 1. Pressure experiment

[0149] Experimental method: Weigh 1010 g of sliced astragalus membranaceus, put the astragalus membranaceus into a multi-functional extraction tank, inject 8 times the amount of acid water (pH value is 5) of astragalus membranaceus into the multi-functional extraction tank, set the stirring speed to 30 r / min, evacuate, apply pressure respectively (250 MPa, 300 MPa, 350 MPa, 400 MPa, 450 MPa, 500 MPa), extract for 0.5 hours, filter the liquid medicine through an 80-mesh sieve inside, add 6 times the amount of alkaline water (pH value is 9) of astragalus membranaceus to the remaining residue, set the stirring speed to 50 r / min, apply pressure to 300 MPa, extract for 0.5 hours, filter, combine the filtrates and transfer them to a concentration tank, control the temperature at 60 ± 5 °C, the vacuum degree is -0.06 to -0.08 Mpa, concentrate to an extract with a relative density of 1.25 - 1.30 (measured at 60 °C), then the astragalus membranaceus extract is obtained.

[0150] 2. Extraction time experiment

[0151] Experimental method: Weigh 1010 g of sliced astragalus membranaceus, put the astragalus membranaceus into a multi-functional extraction tank, inject 8 times the amount of acid water (pH value is 5) of astragalus membranaceus into the multi-functional extraction tank, set the stirring speed to 30 r / min, evacuate, apply pressure to 350 MPa, and perform extraction (20 min, 30 min, 35 min, 40 min, 45 min, 50 min), filter the liquid medicine through an 80-mesh sieve inside, add 6 times the amount of alkaline water (pH value is 9) of astragalus membranaceus to the remaining residue, set the stirring speed to 50 r / min, apply pressure to 350 MPa, and perform extraction (20 min, 30 min, 35 min, 40 min, 45 min, 50 min), filter, combine the filtrates and transfer them to a concentration tank, control the temperature at 60 ± 5 °C, the vacuum degree is -0.06 to -0.08 Mpa, concentrate to an extract with a relative density of 1.25 - 1.30 (measured at 60 °C), then the astragalus membranaceus extract is obtained.

[0152] 3. Experimental results

[0153] According to the above pressure experiment and extraction experiment conditions, the same batch of astragalus membranaceus medicinal materials were extracted separately, and the extracts after extraction were detected according to the pharmacopoeia method. The detailed detection results are shown in Tables 8 and 9 below.

[0154] Table 8 Experimental results of the influence of pressure on the extraction effect of astragalus membranaceus

[0155]

[0156] Table 9 Experimental results of the influence of extraction time on the extraction effect of astragalus membranaceus

[0157]

[0158] Conclusion: When the semi-bionic extraction method reaches the best effect, the combined use of high-pressure extraction method also plays a crucial role. From the above experimental results, it can be seen that when the high-pressure extraction control pressure is 350 Mpa and the extraction time is controlled at 35 min, the best extraction effect of Astragalus membranaceus is achieved. The extraction rate of Astragalus membranaceus extract reaches 13.82%, which is 18.3% higher than that under the best conditions of semi-bionic extraction. At the same time, the content of astragaloside IV increases by 32.9%, and the content of calycosin-7-O-β-D-glucoside increases by 27.8%. Under these conditions, the extraction effect of the semi-bionic extraction method combined with the high-pressure extraction method on Astragalus membranaceus reaches a new high, greatly breaking through the bottleneck of the low extraction rate of Astragalus membranaceus medicinal materials.

[0159] Experimental Example 8: Influence of Surfactant Types on the Extraction Effect of Astragalus membranaceus Extract

[0160] Since the active ingredient in Astragalus membranaceus is astragaloside IV, its solubility in water is extremely low, and the effect of extracting active ingredients is not good. To improve the utilization rate of medicinal materials, reduce costs, and improve the medicinal effect, surfactants are added during extraction to improve the extraction efficiency of Astragalus membranaceus. To compare the influence of adding surfactants before and after and different types of surfactants on the extraction quality of Astragalus membranaceus, the following experiments were carried out for verification. The experimental results are shown in Table 10 below.

[0161] Extraction method: Weigh 1010 g of sliced Astragalus membranaceus, put Astragalus membranaceus into a multi-functional extraction tank, add 60 g of surfactant, inject 8 times the amount of acid water (pH 5) of Astragalus membranaceus into the multi-functional extraction tank, set the stirring speed to 30 r / min, evacuate, pressurize to 350 MPa, extract for 35 min, filter the medicinal liquid through an 80-mesh sieve inside, add 6 times the amount of alkaline water (pH 10) of Astragalus membranaceus to the remaining medicinal residues, set the stirring speed to 50 r / min, pressurize to 350 MPa, extract for 35 min, filter, combine the filtrates and transfer them to a concentration tank, control the temperature at 60 ± 5 °C, and the vacuum degree at -0.06 to -0.08 Mpa, and concentrate to an extract with a relative density of 1.25 to 1.30 (measured at 60 °C) to obtain the Astragalus membranaceus extract.

[0162] Table 10 Experimental Results of the Influence of Surfactant Types on the Extraction Effect of Astragalus membranaceus Extract

[0163]

[0164] Conclusion: The above experimental results show that the extraction effect of Astragalus extract has been improved after adding some surfactants, and there are also some surfactants that have no effect. Among them, the optimal ratio of Tween 60 to Tween 80 is 1:2, and the extraction effect is the best. The extraction rate of the extract can reach 16.82%, which is 21.7% higher than that of the group without surfactant. The content of astragaloside IV is increased by 42%, and the content of calycosin-7-O-β-D-glucoside is increased by 29.8%. The content of the active ingredients in Astragalus extract is increased in a high proportion, achieving an unexpected extraction effect, improving the bioavailability of Astragalus medicinal materials, and enabling the drug to play a more lasting and stable role in the body. At the same time, it also improves the therapeutic effect and stability of the traditional Chinese medicine composition.

[0165] Experimental Example 9: Influence of mixing method on the preparation of preparations

[0166] To ensure the stable quality of the prepared tablets and make the various detection indexes of the tablets meet the standard requirements while improving the extraction rate of the medicinal materials, the solvents added in the mixing process were screened. The detection results of the tablets prepared by each mixing method are shown in the following table.

[0167] Mixing method: Weigh the Ganoderma lucidum paste powder, Astragalus paste powder, starch, and granulated sugar and add them to a mixer. Start stirring and dry mix for 20 minutes. After mixing is completed, let it stand for 5 minutes, then open the lid of the mixer container and add 900 g of ethanol (volume percentages are 65%, 70%, 75%, 80%, 85%, 90% respectively). After all is added, cover the container lid tightly, start stirring, and wet mix for 5 - 10 minutes to make a suitable uniform soft material that can be formed into a ball by hand and dispersed easily by light pressure, for granulation preparation.

[0168] After granulation, drying, sizing, total mixing, and tableting, tablets were prepared. The detection results of each group of experiments are shown in Table 11 below.

[0169] Table 11 Experimental results of the influence of mixing method on the preparation of preparations

[0170]

[0171] Conclusion: The above mixing experimental results show that when different solvents are selected for mixing, the appearance and physicochemical indexes of the prepared tablets are completely different. When the solvent is 85% (v / v) ethanol, the physicochemical detection results of the prepared tablets are the best. Its weight difference and friability have no abnormal tablets, the hardness is moderate and meets the standard requirements, and the dissolution rate at 30 min is 92%, that is, neither the dissolution rate is too fast nor too slow, which can ensure the accurate release of the drug, and a large amount of dissolved substances are just completely released in the gastrointestinal tract, reaching the best release time of the drug for treating diseases and promoting the absorption of the active ingredients of the drug by the human body.

[0172] Experimental Example 10: Influence of traditional Chinese medicine composition on the hypnotic effect of PCPA-insomnia mice

[0173] The traditional Chinese medicine composition of the present invention has the effect of treating insomnia and amnesia. To verify that the traditional Chinese medicine composition of the present invention has the above-mentioned effect of treating insomnia, a sleep experiment was conducted on PCPA-insomnia mice, and the sleep time of the mice after taking the medicine was recorded. The improvement of sleep in insomnia mice by each group of drugs was compared. The treatment drugs included the traditional Chinese medicine composition of the present invention, common sedative and hypnotic drugs (estazolam tablets, eszopiclone tablets), and health foods (melatonin tablets), etc. The experimental content is as follows.

[0174] 1. Experimental materials

[0175] 1.1 Experimental drugs and reagents

[0176] Traditional Chinese medicine composition: The preparation prepared in Example 3 of the present application;

[0177] p-Chlorophenylalanine (PCPA): Shanghai Yuanye Bio-Technology Co., Ltd., batch number: A07GS157185;

[0178] Sodium pentobarbital: Sinopharm Chemical Reagent Co., Ltd., batch number WS20050411;

[0179] Sodium bicarbonate: Wuhan PNSC Life Science & Technology Co., Ltd., batch number: WH01112107SP;

[0180] Estazolam: Shandong Xinyi Pharmaceutical Co., Ltd., national drug approval number H37023047;

[0181] Eszopiclone tablets: Jiangsu Tasly Diyi Pharmaceutical Co., Ltd., national drug approval number H20090209;

[0182] Melatonin tablets: BY-HEALTH Co., Ltd., national food health approval number G20150889;

[0183] Normal saline: Harbin Sanlian Pharmaceutical Co., Ltd., national drug approval number H23020611

[0184] 1.2 Experimental animals

[0185] Kunming strain mice: SPF grade, male, purchased from Liaoning Changsheng Biotechnology Co., Ltd. (Liaoning Experimental Animal Resource Center, NO.SCXK(Liao)2020---0001), body weight 18 - 22g, free access to water and food, room temperature 18 - 24°C, humidity 40% - 50%. Before the experiment, they were adaptively raised for seven days.

[0186] 2. Experimental grouping and drug administration

[0187] 2.1 Experimental animal grouping

[0188] The mice were randomly divided into 6 groups according to the suprathreshold experiment: blank control group, model control group, eszopiclone tablet 2mg positive drug group, zaleplon tablet 2mg positive drug group, melatonin tablet 0.4g positive drug group, and suprathreshold insomnia traditional Chinese medicine composition group. There were 10 mice in each group, and they were raised in an experimental environment with constant temperature and humidity, with free access to water and food.

[0189] 2.2 Preparation of PCPA insomnia mouse model

[0190] According to the preliminary pretest of the research group and referring to the literature, prepare the PCPA suspension: prepare a 35mg / mL PCPA suspension with weakly alkaline saline (PH10.1), water bath at 80°C for 20 min, and mix well. Except for the blank control group, each group of mice was intraperitoneally injected with 350mg / kg of PCPA suspension at 0.1mL / 10g body weight once a day for three consecutive days. The blank control group was given an equal amount of weakly alkaline saline. Model evaluation: After modeling, the disappearance of the circadian rhythm, messy hair, less food intake, irritability and fighting, wet bedding, and abnormally gray feces in the mice indicated the successful preparation of the model.

[0191] 2.3 Administration

[0192] The mice in each group were gavaged at 10:00 am every day. The gavage dose of each group was converted according to the equivalent dose of humans and mice. The measured body weight of the mice was 20±2g. The conversion formula D b ’=D 艾司唑仑片2mg ×R 艾司唑仑片2mgb ×Sb (R 艾司唑仑片2mgb =12.33, Sb = 0.874) was used to obtain the dose of the experimental drug, and the gavage was controlled at 0.1mL / 10g. The blank control group and the model control group were gavaged with an equal volume of normal saline once a day for seven consecutive days.

[0193] 3. Detection of suprathreshold dose pentobarbital sodium hypnosis experiment indicators

[0194] Grouping, modeling, and administration were all carried out according to the above methods. After 30 min of the last administration, each group of mice was intraperitoneally injected with 46mg / kg of pentobarbital sodium (the dose was obtained through preliminary testing, the minimum dose at which 100% of the mice had the disappearance of the righting reflex). Observe whether the mice showed sleep phenomena. The disappearance of the righting reflex was used as the sign of falling asleep. When the mouse was placed in the dorsal recumbent position and could not right itself for more than 30 s, it was considered that the righting reflex disappeared and it entered sleep. The recovery of the righting reflex was the awakening of the animal. The time from the start of injecting pentobarbital sodium to the disappearance of the righting reflex of the mouse was the sleep latency of the animal, and the time from the disappearance of the righting reflex to the recovery was the sleep time of the animal. The sleep latency and sleep time of each group of mice were recorded respectively.

[0195] 4. Experimental Results of the Effect of the Traditional Chinese Medicine Composition for Treating Insomnia on the Sleep Time of Mice Induced by Suprathreshold Dose of Pentobarbital Sodium

[0196] Compared with the normal control group, the sleep latency of the mice in the model control group was prolonged (P<0.01), and the sleep time was shortened (P<0.01). After treating the mice in each group with the drugs for treating insomnia, the sleep condition of the PCPA-insomnia mice was significantly improved. See Tables 12 and 13. The results of the determination of the sleep onset latency showed that all the drug administration groups were superior to the positive drug group, and the induced sleep time was also superior to the positive drug group.

[0197] Table 12 Effect of Suprathreshold Experiment on Sleep Onset Latency

[0198]

[0199] Note: Compared with the blank control group, the model control group had significant differences. # indicates P<0.05; compared with the model control group, each drug administration group had significant differences. * indicates P<0.05, and ** indicates P<0.01.

[0200] Table 13 Effect of Suprathreshold Experiment on Sleep Time

[0201]

[0202] Note: Compared with the blank control group, the model control group had significant differences. # indicates P<0.05; compared with the model control group, each drug administration group had significant differences. * indicates P<0.05.

[0203] Conclusion: Through the pharmacodynamic experiments, it can be known that compared with the commercially available products, the traditional Chinese medicine composition of this application has a significant effect on treating neurasthenia and insomnia and amnesia. The sleep onset latency was shortened by 23.1% compared with the model group, and at the same time, the sleep time was increased by 1.9 times compared with the model group. The duration of the sleep time was higher than that of the commonly used products for treating insomnia such as melatonin tablets, eszopiclone tablets, and estazolam tablets.

[0204] Experimental Example 11: Clinical Trial

[0205] With the acceleration of the life rhythm and the increase of work pressure, people are in a tense and anxious mood for a long time, which is prone to induce neurasthenia. At present, the pathogenesis of neurasthenia is not yet clear. Mostly, due to the long-term excessive pressure on patients, the cerebral blood vessels contract irregularly, inhibiting the activity of the cerebral cortex, resulting in low mood and onset of the disease. Due to its complex pathological mechanism, there is still no specific therapeutic drug in clinical practice. At the same time, it is accompanied by symptoms of insomnia, seriously affecting the quality of work and life. The traditional Chinese medicine composition of this application has the effect of treating neurasthenia, insomnia and amnesia. Now, a clinical trial is carried out on some such patients, and the detailed treatment plan and results are as follows.

[0206] 1. Diagnostic Criteria

[0207] Neurasthenia: Patients experience persistent physical fatigue or weakness for a long time. There may also be symptoms such as chest pain and rapid heartbeat. Moreover, patients are overly sensitive to stimuli, such as being particularly sensitive to sounds, lights, or slight physical discomfort. There may also be complications such as sleep disorders and anxiety disorders. Some patients have psychosomatic symptoms such as tinnitus, palpitation, chest tightness, dyspepsia, frequent urination, excessive sweating, impotence, or menstrual disorders. There will also be manifestations such as grogginess after getting up, feeling stiff in the morning, and being unable to concentrate.

[0208] Insomnia and amnesia: The main manifestations of patients are symptoms such as difficulty falling asleep, easy waking, early waking, difficulty falling asleep again after waking, and poor sleep quality. At the same time, there are daytime drowsiness, physical decline, memory loss, accompanied by manifestations such as nervousness and depression. In severe cases, there are autonomic nerve disorder symptoms such as rapid heart rate, elevated body temperature, and peripheral vasoconstriction.

[0209] 2. Case inclusion criteria

[0210] (1) Meet the diagnostic criteria for neurasthenia;

[0211] (2) Meet the diagnostic criteria for insomnia;

[0212] (3) Gender is not limited, age is 25 - 58 years old:

[0213] (4) Have not used sedative and hypnotic drugs recently:

[0214] (5) Voluntarily participate in this clinical study and actively cooperate with recording the condition.

[0215] 3. Trial protocol

[0216] 3.1 Case selection

[0217] According to the above inclusion criteria, 80 patients with neurasthenia accompanied by insomnia and amnesia were selected as the research objects of this study. They were randomly divided into a control group and an experimental group, with 20 patients in each group. Control group 1: 11 males and 9 females, aged 25 - 54 years old; Control group 2: 10 males and 10 females, aged 25 - 58 years old; Experimental group 1: 9 males and 11 females, aged 27 - 55 years old; Experimental group 2: 12 males and 8 females, aged 26 - 56 years old. There was no significant difference in the general data of the four groups of patients (P > 0.05), and they were comparable.

[0218] 3.2 Treatment method

[0219] Experimental group 1: Orally take the traditional Chinese medicine composition (prepared in Example 3), 5 pills each time, 2 times a day;

[0220] Test Group 2: Orally administered traditional Chinese medicine composition (prepared in Example 3), 5 capsules each time, 3 times a day; Control Group 1: Orally administered An'er Mian Capsules, 5 capsules each time, 3 times a day;

[0221] Control Group 2: Orally administered Estazolam Tablets, 1 tablet each time, 3 times a day;

[0222] All of the above four groups were continuously administered for treatment for 1 month.

[0223] 4. Evaluation Criteria and Test Results

[0224] 4.1 Evaluation Criteria

[0225] Cured: Symptoms such as neurasthenia, insomnia, and amnesia disappear, and return to normal living standards;

[0226] Markedly effective: Symptoms of neurasthenia disappear, and symptoms such as difficulty falling asleep, insomnia, and dreaminess occur occasionally, and memory is improved;

[0227] Effective: Symptoms of neurasthenia are somewhat relieved, the frequency of difficulty falling asleep, insomnia, and dreaminess decreases, and memory shows no obvious change;

[0228] Ineffective: Symptoms such as neurasthenia, insomnia, and amnesia are not improved, and there is a tendency for individual symptoms to worsen.

[0229] 4.2 Test Results

[0230] The effects of the four groups of tests in treating neurasthenia, insomnia, and amnesia are shown in Table 14 below.

[0231] Table 14 Statistical Results of the Treatment Effective Rates of the Four Groups of Test Patients

[0232] Group Number of cases Cured Markedly effective Effective Ineffective Effective rate % Cure rate % Test group 1 20 7 8 3 2 90 35 Test group 2 20 9 7 3 1 95 45 Control group 1 20 3 5 8 4 80 15 Control group 2 20 0 4 9 7 65 0

[0233] Conclusion: The clinical trial results show that the traditional Chinese medicine composition of this application has the most significant treatment effective rate for symptoms such as neurasthenia, insomnia, and amnesia. Among them, the treatment effective rate of the high-dose Test Group 2 is as high as 95%, and the cure rate also reaches 45%. The treatment effective rate and cure rate of the low-dose Test Group 1 are also higher than those of Control Group 1 and Control Group 2. Control Group 1 is a special drug for treating neurasthenia, insomnia, and amnesia. The low-dose group of the traditional Chinese medicine composition of this application achieves the treatment effect of the normal dose of Control Group 1. This test result shows that the traditional Chinese medicine composition of this application has a good treatment effect on patients with neurasthenia, insomnia, and amnesia. During the medication period, the insomnia symptoms of most patients were relieved, and the memory was significantly improved.

Claims

1. A series of traditional Chinese medicine compositions of the Bu Jue Xiao type for neurasthenia, insomnia, and amnesia, which are made from the following raw materials in parts by weight: Ganoderma lucidum 1200 - 2500 parts, Astragalus membranaceus 1100 - 2550 parts, starch 20 - 70 parts, granulated sugar 5 - 50 parts, magnesium stearate 1 - 15 parts.

2. The traditional Chinese medicine composition according to claim 1, wherein, The composition is made from the following raw materials in parts by weight: Ganoderma lucidum 1635 - 2170 parts, Astragalus membranaceus 1810 - 2220 parts, starch 30 - 50 parts, granulated sugar 10 - 30 parts, magnesium stearate 3 - 10 parts; Preferably, the composition is made from the following raw materials in parts by weight: Ganoderma lucidum 1800 - 2000 parts, Astragalus membranaceus 1900 - 2100 parts, starch 35 - 45 parts, granulated sugar 15 - 25 parts, magnesium stearate 5 - 8 parts; Preferably, the composition is made from the following raw materials in parts by weight: Ganoderma lucidum 1900 parts, Astragalus membranaceus 2020 parts, starch 40 parts, granulated sugar 20 parts, magnesium stearate 6 parts; Preferably, the composition is in tablet form; Preferably, the content of ganoderma polysaccharide in the composition is not less than 0.8% (m / m), the content of triterpenoids and sterols is not less than 2.0% (m / m), the content of astragaloside IV is not less than 3.0% (m / m), and the content of calycosin - 7 - O - β - D - glucoside is not less than 2.0% (m / m); Preferably, the content of ganoderma polysaccharide in the composition is not less than 2.16% (m / m), the content of triterpenoids and sterols is not less than 5.93% (m / m), the content of astragaloside IV is not less than 4.12% (m / m), and the content of calycosin - 7 - O - β - D - glucoside is not less than 3.24% (m / m); Preferably, the content of ganoderma polysaccharide in the composition is not less than 3.01% (m / m), the content of triterpenoids and sterols is not less than 7.84% (m / m), the content of astragaloside IV is not less than 5.44% (m / m), and the content of calycosin - 7 - O - β - D - glucoside is not less than 4.57% (m / m); Preferably, the content of ganoderma polysaccharide in the composition is 2.16% - 3.42% (m / m), the content of triterpenoids and sterols is 5.93% - 8.27% (m / m), the content of astragaloside IV is 4.12% - 10.27% (m / m), and the content of calycosin - 7 - O - β - D - glucoside is 3.24% - 7.58% (m / m); Preferably, the content of ganoderma polysaccharide in the composition is 3.01% - 3.42% (m / m), the content of triterpenoids and sterols is 7.84% - 8.27% (m / m), the content of astragaloside IV is 5.44% - 10.27% (m / m), and the content of calycosin - 7 - O - β - D - glucoside is 4.57% - 7.58% (m / m); More preferably, the content of ganoderma polysaccharide in the composition is 3.42% (m / m), the content of triterpenoids and sterols is 8.27% (m / m), the content of astragaloside IV is 10.27% (m / m), and the content of calycosin - 7 - O - β - D - glucoside is 7.58% (m / m).

3. A preparation method of the traditional Chinese medicine composition according to claim 1 or 2, which comprises the following steps: Add Ganoderma lucidum paste powder, Astragalus membranaceus paste powder, starch, and granulated sugar into a mixer for dry mixing. After the mixing is completed, add an organic solvent for wet mixing to obtain the product.

4. The preparation method according to claim 3, wherein The time for dry mixing is 15 - 40 minutes, preferably 20 minutes; Preferably, the time for wet mixing is 3 - 30 minutes, preferably 5 - 10 minutes; Preferably, the organic solvent is ethanol, preferably 85% (v / v) ethanol.

5. The preparation method according to claim 3 or 4, wherein The preparation method of the Ganoderma lucidum paste powder is as follows: Weigh Ganoderma lucidum, crush it to a particle size of Φ15 - 25 mm (preferably Φ22 mm) using a crusher, and after crushing, put it into an extraction device with a double-layer movable screen. Inject 5 - 8 times the amount of hot water (water temperature is 85℃ - 100℃) of Ganoderma lucidum, and carry out extraction of the medicinal materials in the extraction device with the double-layer movable screen. Move the double-layer movable screen once every half hour during the extraction process, so that the medicinal materials are squeezed and then released between the double-layer movable screen, filter, concentrate the filtrate, and dry it to obtain the product.

6. The preparation method according to claim 5, wherein, Moving the double-layer movable screen once every half hour during the extraction process means moving the double-layer movable screen up and down in the order from the bottom, middle to the top of the extraction device; Preferably, the extraction can be repeated multiple times, for example, 2 times; Preferably, the temperature for concentration is 70 - 75℃; Preferably, the concentration means concentrating the filtrate to a relative density of 1.25 ± 0.05 at 70℃.

7. The preparation method according to claim 5 or 6, wherein The drying means drying under vacuum decompression conditions using double-layer stainless steel thin sheets; Preferably, the vacuum degree for drying is -0.06 to -0.08 Mpa.

8. The production method according to any one of claims 3 to 7, wherein, The preparation method of the Astragalus membranaceus paste powder is as follows: Weigh Astragalus membranaceus, add a surfactant, inject acid water, stir, evacuate, pressurize, extract, filter the medicinal liquid, add alkaline water to the remaining medicinal residues, stir, pressurize, extract, filter, combine the filtrates and concentrate, and dry to obtain the product.

9. The preparation method according to claim 8, wherein, The surfactant is selected from one or more of polyethylene glycol, Tween 20, Tween 60, Tween 80, cetyltrimethylammonium bromide, preferably selected from one or more of Tween 20, Tween 60, Tween 80, more preferably a mixture of Tween 80 and Tween 60, and most preferably a mixture of Tween 60 and Tween 80 with a volume ratio of 1:2; Preferably, the acid water includes but is not limited to hydrochloric acid aqueous solution, sulfuric acid aqueous solution, phosphoric acid aqueous solution, citric acid aqueous solution, preferably phosphoric acid aqueous solution; Preferably, the acid water means the pH value is 4 - 6, preferably 5 - 6, more preferably 5; Preferably, the alkaline water includes but is not limited to sodium hydroxide solution, potassium hydroxide solution, calcium hydroxide solution, ammonia water, carbonate solution, phosphate solution, preferably sodium hydroxide aqueous solution; Preferably, the alkaline water means the pH value is 8 - 11, preferably 8 - 10, more preferably 10; Preferably, after injecting the acid water and before adding the alkaline water, the pressure is 300 - 450 MPa, preferably 350 MPa; Preferably, after injecting the acid water and before adding the alkaline water, the extraction time is 30 - 45 min, preferably 35 min.

10. The preparation method according to claim 8 or 9, wherein The temperature for concentration is 55 - 65℃; Preferably, the concentration means concentrating the filtrate to a relative density of 1.25 - 1.30 at 60℃; Preferably, the drying means drying under vacuum decompression conditions using double-layer stainless steel thin sheets; Preferably, the vacuum degree of the drying is -0.06 to -0.08 Mpa.

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