A traditional Chinese medicine composition for tonifying liver and kidney, soothing liver, strengthening spleen, tranquilizing and sleep-aiding and a pill preparation method thereof

Abstract

This invention belongs to the field of biomedical technology and discloses a traditional Chinese medicine composition and its pill preparation method that simultaneously nourishes the liver and kidneys, soothes the liver, strengthens the spleen, calms the mind, and aids sleep. Cornus officinalis is used as the principal ingredient to nourish the liver and kidneys and consolidate essence and blood; Astragalus membranaceus (processed), Dendrobium officinale, Lilium brownii, Panax quinquefolius, and Angelica sinensis are used as assistant ingredients; Hordeum vulgare (raw) is used as adjuvant ingredient; and Rosa rugosa and Albizia julibrissin are used as guiding ingredients. This invention addresses the core issues of deficiency of liver and kidney essence and blood, liver stagnation, deficiency of both qi and yin, and spleen and stomach dysfunction. The composition is balanced and moderate, nourishing without being greasy or cloying, soothing the liver without being pungent or damaging to essence. Long-term use does not cause side effects such as internal heat, abdominal distension, or decreased appetite. It can improve symptoms such as insomnia, excessive dreaming, lower back and knee weakness, fatigue, and dull complexion. The process of this invention divides the medicinal materials into long-term, medium-term, and short-term decoction groups according to the heat resistance and volatility of the effective components. The decoction is carried out in stages with micro-pressure, sealed temperature control, fully preserving the aromatic volatile oils of Rosa rugosa and Albizia julibrissin and the heat-sensitive saponins of Panax quinquefolius, avoiding high-temperature damage.

Description

Technical Field

[0001] This invention belongs to the field of biomedical technology, specifically a traditional Chinese medicine composition that simultaneously nourishes the liver and kidneys, soothes the liver, strengthens the spleen, calms the mind, and aids sleep, and its pill preparation method. Background Technology

[0002] Traditional Chinese medicine theory holds that the liver and kidneys share a common origin and mutually generate essence and blood. The liver governs the free flow of qi and the spleen governs digestion and transformation. Long-term irregular sleep patterns and emotional distress can directly lead to a complex sub-health condition characterized by deficiency of liver and kidney essence and blood, liver qi stagnation, deficiency of both qi and yin, and impaired spleen and stomach function. Clinical manifestations include a combination of symptoms such as insomnia, anxiety, depression, lower back and knee weakness, dizziness, tinnitus, irregular menstruation, dull complexion, fatigue, abdominal distension, and indigestion. Treating only one organ is insufficient to fundamentally improve this complex sub-health condition. Current market products targeting this sub-health condition suffer from the following technical problems: Most products focus only on calming the mind and aiding sleep, or simply replenishing qi or kidneys. They do not follow the core theory of the common origin of liver and kidneys to achieve the synergistic effects of simultaneously replenishing the liver and kidneys, soothing the liver, strengthening the spleen, and calming the mind. They can only relieve surface symptoms and cannot fundamentally regulate the deficiency of essence and blood and the stagnation of qi. They treat the symptoms but not the root cause.

[0003] Some formulas contain excessive amounts of nourishing herbs, which are too rich and greasy, hindering the stomach and easily generating phlegm and dampness, thus increasing the burden on the spleen and stomach. Some formulas contain excessively pungent and dispersing herbs for soothing the liver, which depletes the essence and blood of the liver and kidneys, causing those who are already deficient to become even weaker. Furthermore, they do not take into account replenishing qi and nourishing yin, or strengthening the spleen and aiding digestion. Long-term use can easily lead to adverse reactions such as internal heat, abdominal distension, and decreased appetite.

[0004] Traditional processes often involve one-time high-temperature decoction or simple powdering, which easily destroys the aromatic volatile oils of floral medicinal materials such as roses and mimosa flowers, as well as the heat-sensitive saponins in American ginseng, resulting in a significant loss of effective ingredients. At the same time, there are also problems such as insufficient dissolution of effective ingredients, large particle size, and low bioavailability.

[0005] Existing products lack an integrated process of decocting all components in stages and mixing raw medicinal powders and extracts into pills. This makes it impossible to ensure the full dissolution of effective ingredients and the complete preservation of the original medicinal properties, resulting in poor efficacy stability and short duration of action. Furthermore, decoctions are inconvenient to carry, powders have poor taste and low absorption efficiency, making it difficult to meet the needs of long-term daily conditioning. Summary of the Invention

[0006] The purpose of this invention is to provide a traditional Chinese medicine composition that simultaneously nourishes the liver and kidneys, soothes the liver, strengthens the spleen, calms the mind, and aids sleep, as well as a method for preparing its pill form, in order to solve one or more of the problems mentioned in the background art.

[0007] To achieve the above objectives, the present invention provides the following technical solution: a method for preparing a pill of a traditional Chinese medicine composition that simultaneously nourishes the liver and kidneys, soothes the liver, strengthens the spleen, calms the mind, and aids sleep, comprising the following process stages: Furthermore, in the formulation stage, the pills are made from nine medicinal and edible ingredients in specific weight proportions. The weight proportions of each ingredient are as follows: Cornus officinalis 70-90 parts, Lilium brownii 15-25 parts, Angelica sinensis 15-25 parts, Astragalus membranaceus (processed) 20-40 parts, Dendrobium officinale 20-40 parts, Hordeum vulgare 15-25 parts, Rosa rugosa 25-35 parts, Albizia julibrissin 20-40 parts, and Panax quinquefolius 10-20 parts. This composition follows the principles of traditional Chinese medicine, with Cornus officinalis as the principal ingredient, Astragalus membranaceus (processed), Dendrobium officinale, Lilium brownii, Angelica sinensis, and Panax quinquefolius as assistant ingredients, Hordeum vulgare 20-40 parts, and Rosa rugosa and Albizia julibrissin as guiding ingredients.

[0008] Cornus officinalis nourishes the liver and kidneys, consolidates essence and blood, and has a mild medicinal property; Astragalus membranaceus (processed) tonifies qi and strengthens the spleen, Dendrobium officinale (processed) nourishes yin and clears heat, and Lilium brownii (processed) calms the mind and soothes the nerves. The three herbs work together to tonify qi and nourish yin, strengthen the spleen and promote digestion; Angelica sinensis (processed) nourishes blood and soothes the liver, Hordeum vulgare (processed) strengthens the spleen and harmonizes the middle jiao, and Rosa rugosa (processed) and Albizia julibrissin (processed) soothe the liver and relieve depression. The four herbs soothe the liver, regulate qi, nourish blood and harmonize the middle jiao; Panax quinquefolius (processed) tonifies qi and nourishes yin, and harmonizes the other herbs. The entire formula is well-balanced, achieving nourishment without being greasy and hindering the stomach, and soothing the liver without being pungent and damaging to essence.

[0009] Furthermore, in the pretreatment stage of the medicinal materials, the raw materials are manually sorted and impurities are removed, including mud, insect-infested parts, moldy parts, rotten parts and non-medicinal impurities. The surface of the raw materials is rinsed with low-temperature flowing pure water to avoid the loss of effective components due to prolonged soaking. After rinsing, the raw materials are placed in a room temperature environment to drain naturally. Then, the raw materials are classified and trimmed to remove the fibrous roots of root and rhizome medicinal materials and the petals and stamens of flower medicinal materials, retaining only the highly active medicinal parts. After processing, the raw materials undergo a triple test for moisture, impurities, and activity. The qualified raw materials are classified and sealed and stored in a cool, clean, temperature- and humidity-controlled area, with moisture-proof, light-proof, and oxidation-proof protective measures taken throughout the process.

[0010] Moisture content was determined by drying, with a minimum moisture content of 12.0% for qualified raw materials. Impurities were determined by sieving, with a minimum impurity content of 2.0%. Preliminary activity testing was performed using thin-layer chromatography, ensuring clear characteristic spots without negative interference, thus guaranteeing that the raw materials met pharmaceutical activity standards.

[0011] Furthermore, in the gradient decoction stage, based on the differences in heat resistance and volatility of the effective components of the medicinal materials, the medicinal materials are divided into a long decoction group, a medium decoction group, and a short decoction group. The decoction is prepared by a three-stage decoction process that combines thorough soaking with micro-pressure closed temperature control. The micro-pressure closed temperature control decoction is completed using a multi-functional low-temperature closed extraction tank for traditional Chinese medicine. The micro-pressure is maintained stably throughout the process at 0.01-0.05 MPa, and the temperature control accuracy is controlled within ±1℃. The closed environment can effectively prevent the loss of volatile oils and heat-sensitive components of flowers, and retain the active substances of the medicinal materials to the greatest extent. The long-decoction group consists of root and rhizome herbs and tonifying herbs, whose active ingredients are highly heat-resistant and require long-term decoction to dissolve. The medium-decoction group consists of flower herbs containing volatile aromatic oils, which are easily lost if the decoction time is too long. The short-decoction group consists of American ginseng, which contains heat-sensitive saponins that are easily degraded under high temperature conditions. Segmented feeding can protect different types of active ingredients.

[0012] First, take Cornus officinalis, Lilium brownii, Angelica sinensis, Astragalus membranaceus (processed), Dendrobium officinale, and raw malt to form a long decoction group. Add 8 to 10 times the total weight of the group of herbs in purified drinking water and let it soak at room temperature for 30 to 40 minutes to allow the hard herbs to fully expand. After boiling over high heat, adjust the temperature to a constant 90-95℃ and simmer over low heat in a sealed container for 25 minutes. Next, add the medium decoction group consisting of rose and mimosa flowers, maintain a constant temperature of 90℃ and continue to simmer over a closed flame for 5 minutes, for a total simmering time of 30 minutes. The aromatic volatile oils in the floral herbs are retained through a slightly pressurized and sealed environment. Then, add the short decoction group consisting of American ginseng, cool down to 88℃ or below, simmer over a closed flame for 3 minutes, and turn off the heat after a total simmering time of 33 minutes, to retain the heat-sensitive saponin active ingredients in the American ginseng. After decoction, filter the liquid through an 80-100 mesh medicinal sieve and collect the first decoction. Add 6 times the amount of purified water to the remaining dregs, simmer at 90℃ for 15 minutes, and then filter to obtain the second decoction. Combine the filtrates obtained from the two decoctions. The combined filtrate was concentrated at low temperature in a vacuum negative pressure environment at 60℃ or below to obtain a thick extract with a relative density of 1.25 to 1.30 at 60℃. The entire process was carried out at low temperature and in a closed environment to protect the heat-sensitive and volatile active ingredients and preserve them intact.

[0013] The concentration operation was carried out using a double-effect vacuum concentrator, with the vacuum negative pressure controlled at -0.06 to -0.08 MPa. The relative density of the viscous extract was measured using the hydrometer bottle method under constant temperature water bath conditions at 60℃.

[0014] Tests showed that the volatile oil retention rate of rose and mimosa flowers was ≥92%, and the heat-sensitive saponin retention rate of American ginseng was ≥90%, indicating that the retention of effective ingredients was higher than that of traditional high-temperature one-time decoction methods.

[0015] Furthermore, in the powder preparation stage, pretreated qualified medicinal materials with the same weight ratio as the decoction formula are taken and placed inside a gradient low temperature drying device. The drying is carried out at a constant temperature of 45-50℃ for 1.5 to 3 hours. After drying, the medicinal materials are pulverized by a cell wall breaking pulverizer. The pulverized material is then passed through a 110-mesh sieve to obtain the whole-component original medicinal powder. This medicinal powder can break the plant cell wall structure and improve the dissolution rate of the effective components of the medicinal materials and the absorption efficiency of the human body. The cell wall breaking and pulverizing equipment adopts an ultra-micro airflow pulverizer. The pulverization process is carried out at low temperature with no heat loss. After pulverization, the cell wall breaking rate of the medicinal materials is not less than 90%. After sieving with a 110-mesh sieve, the particle size is uniform and fine, which improves the dissolution rate of effective ingredients and the absorption and utilization rate by the human body.

[0016] The drying equipment is a low-temperature hot air circulating oven. The wind speed during the drying process is controlled at 0.8 to 1.2 m / s, and the entire process is sealed and ventilated to avoid contamination. The drying endpoint is when the medicinal material is easily crushed by hand and the moisture content drops to 6.0% to 8.0%, to prevent the active ingredients from being degraded by heat.

[0017] After pulverization and sieving, the raw medicinal powder is sealed and stored in a cool, moisture-proof, light-proof, and sterile airtight container to prevent the aroma of the medicinal materials from evaporating and the active ingredients from oxidizing and deteriorating, thus preserving the original medicinal properties and active ingredients of the medicinal materials.

[0018] The thick extract is mixed with the cell wall-broken raw medicinal powder to form pills. The extract components can be quickly dissolved, while the raw medicinal powder components can be slowly released, which takes into account both rapid onset and sustained effect, and improves the absorption efficiency of the components.

[0019] Furthermore, in the soft material preparation stage, the thick extract prepared by low-temperature vacuum concentration and the whole-component raw medicinal powder after cell wall disruption are added to a sterile mixing device at a mass ratio of 1:1.3. Under this ratio, the thick extract can improve the dissolution rate of the active ingredients, and the raw medicinal powder can retain the original medicinal properties and continuous release ability of the medicinal materials. The mixture of the two can ensure the formability of the soft material, while improving the stability of the efficacy and bioavailability. First, the material is stirred at a low speed of 20-30 r / min for 20 minutes to fully disperse and mix the materials, and then kneaded at a low speed of 25-35 r / min for 10 minutes to make the soft material uniform in texture and moderately viscous. The total stirring time is controlled at 30-40 minutes. After stirring, the standard pelleting soft material is obtained. The soft material is prepared and used immediately, and stored in a sealed and light-proof manner throughout the process to avoid moisture loss and material deterioration caused by long-term storage.

[0020] The mixing equipment used is a trough-type wet mixing granulator. The mixing operation is carried out in a clean area with a temperature of 18-25℃ and a relative humidity of 45%-60%, and the whole process is sealed to avoid dust pollution and component volatilization.

[0021] Furthermore, in the dosage form forming stage, during the preparation of water pills, a small amount of whole-component virgin medicinal powder is selected as a lubricant and forming aid. The prepared soft material is put into the pill-making equipment, processed into uniform pill strips, and then rolled into pills. The pill diameter is controlled to be 3-4 mm. After forming, the pills are dried at a low temperature gradient of 55-60℃ for 2-3 hours to control the moisture content of the pills to ≤8.5%. The resulting water pill dosage form is stable, has a fast disintegration rate, and takes effect quickly. The pill-making equipment is a fully automatic Chinese medicine pill-making machine with a pill diameter control accuracy of ±0.2mm, ensuring that the pills are of uniform size and have a regular appearance, meeting the requirements for clinical administration and quality control.

[0022] In the preparation of honey pills, honey is first heated and refined to a medium temperature of 118℃ and a water content of 14% to 16%. Impurities and surface foam in the honey are removed by filtration. Then, the raw medicinal powder and refined honey are kneaded together in a mass ratio of 1:0.9 to 1.1 and processed into large honey pills of 3 to 9g each. After shaping, the pills are placed in a clean and cool environment to air dry naturally, and the moisture content of the honey pills is controlled to be ≤14.0%. The resulting honey pills have a soft and glutinous texture, mild medicinal properties, and a long storage period.

[0023] The honey refining process uses a jacketed honey refining pot, with a uniform heating rate of 2-3℃ / min. The pot is stirred at a low speed throughout the process to prevent scorching. The honey refining process ends when it turns light golden yellow and is sticky to the touch without being stringy, ensuring the adhesion and stability of the honey pills.

[0024] Water pills disintegrate quickly, making them suitable for those who need rapid onset of action; honey pills have good adhesion and milder effects, making them suitable for long-term conditioning. The two dosage forms can be adapted to different needs and usage scenarios.

[0025] Furthermore, in the quality control and packaging stage, the formed pills are screened and graded using a vibrating screen to remove broken pills, irregularly shaped pills, and unqualified pills of uneven size. Then, the qualified pills are polished using polishing equipment to make the pill surface smooth and the color uniform, thus optimizing the appearance and taste of the pills. Subsequently, the formed pills are subjected to quality testing, and the testing indicators include moisture, weight difference, dissolution rate, retention rate of active ingredients, and volatile oil content. Once all indicators meet the standards, the product is judged to be qualified. The characteristic components of the volatile oil were detected by gas chromatography, and the content was not less than 0.15%; the total saponins of American ginseng were detected by high performance liquid chromatography, and the retention rate of the effective components was not less than 85%; the dissolution rate was detected by the paddle method, and the dissolution rate was not less than 80% after 45 minutes; the moisture content and weight difference met the requirements of the general rules for pills in the pharmacopoeia.

[0026] The polishing equipment is a multi-functional pill polishing machine with a polishing speed of 300-500 r / min and a polishing time of 15-20 minutes. It can make the pill surface smooth and round without pitting, improving the appearance of the finished product and its compliance with the user's needs.

[0027] Qualified pills are sealed in pharmaceutical sterile aluminum foil bags or light-proof sealed bottles and stored in a cool, dry, light-proof, constant-temperature environment.

[0028] The thickness of the pharmaceutical sterile aluminum foil bag is 0.08-0.12mm, and the light-proof sealed bottle is a brown pharmaceutical glass bottle; the finished product should be stored away from heat sources and strong light, and the temperature and humidity should be checked regularly to prevent the pills from absorbing moisture, becoming moldy, and degrading the active ingredients.

[0029] This invention also provides a traditional Chinese medicine composition that simultaneously nourishes the liver and kidneys, soothes the liver, strengthens the spleen, calms the mind, and aids sleep. It is prepared using the above-mentioned method and consists of the following ingredients in parts by weight: Cornus officinalis 70-90 parts, Lilium brownii 15-25 parts, Angelica sinensis 15-25 parts, Astragalus membranaceus (processed) 20-40 parts, Dendrobium officinale 20-40 parts, Hordeum vulgare 15-25 parts, Rosa rugosa 25-35 parts, Albizia julibrissin 20-40 parts, and Panax quinquefolius 10-20 parts.

[0030] The beneficial effects of this invention are as follows: 1. In this invention, Cornus officinalis is used as the principal ingredient to nourish the liver and kidneys and consolidate essence and blood; Astragalus membranaceus (processed), Dendrobium officinale, Lilium brownii, Panax quinquefolius, and Angelica sinensis are used as assistant ingredients; Hordeum vulgare (raw) is used as adjuvant ingredients; and Rosa rugosa and Albizia julibrissin are used as guiding ingredients. This invention addresses the core issues of deficiency of liver and kidney essence and blood, liver stagnation, deficiency of both qi and yin, and spleen and stomach dysfunction. At the same time, the ingredients are balanced and moderate, nourishing without being greasy and hindering the stomach, and soothing the liver without being pungent and damaging essence. Long-term use does not cause side effects such as internal heat, abdominal distension, or decreased appetite. It can improve symptoms such as insomnia, dreaminess, soreness of the waist and knees, fatigue, and dull complexion.

[0031] 2. The process of this invention divides the medicinal materials into three groups based on the heat resistance and volatility of the active ingredients: long decoction, medium decoction, and short decoction. The decoction is carried out in stages with micro-pressure and temperature control to fully preserve the aromatic volatile oils of rose and mimosa flowers and the heat-sensitive saponins of American ginseng, avoiding damage from high temperatures. The filtrates from the two decoctions are combined and concentrated under low-temperature vacuum to ensure full dissolution of the ingredients. At the same time, the plant cell walls are broken by low-temperature drying at 45-50℃ and pulverizing with 110 mesh. The thick extract is then mixed with the raw medicinal powder to form pills, which balances high solubility of the extract with preservation of the original medicinal aroma. The retention rate of active ingredients is greatly improved, resulting in faster absorption and more stable and lasting efficacy.

[0032] 3. The water pills in this invention disintegrate quickly and take effect rapidly, while the honey pills have a soft and glutinous texture, mild medicinal properties, and a long shelf life, which can meet the preferences of different groups of people. The entire preparation process strictly controls parameters such as pill diameter, drying temperature, and moisture content. The quality control process covers multiple indicators such as moisture content, weight difference, dissolution rate, and retention rate of effective ingredients. The finished product is aseptically packaged and can be stored in a cool and dry place. It is convenient to take and carry, improves the compliance of sub-healthy people with conditioning, and is suitable for long-term home and travel conditioning. Attached Figure Description

[0033] Figure 1 This is a flowchart of the overall process of the preparation method of the present invention. Detailed Implementation

[0034] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0035] like Figure 1 As shown, this embodiment of the invention provides a method for preparing a pill of a traditional Chinese medicine composition that simultaneously nourishes the liver and kidneys, soothes the liver, strengthens the spleen, calms the mind, and aids sleep; Example 1 Low-dose group Ingredients by weight: 70 parts Cornus officinalis, 15 parts Lilium brownii, 15 parts Angelica sinensis, 20 parts Astragalus membranaceus (processed), 20 parts Dendrobium officinale, 15 parts raw malt, 25 parts Rosa rugosa, 20 parts Albizia julibrissin, and 10 parts Panax quinquefolius.

[0036] Optimal Dosage Group in Example 2 Ingredients by weight: 80 parts Cornus officinalis, 20 parts Lilium brownii, 20 parts Angelica sinensis, 30 parts Astragalus membranaceus (processed), 30 parts Dendrobium officinale, 20 parts raw malt, 30 parts rose, 30 parts Albizia julibrissin, and 15 parts American ginseng.

[0037] Example 3 High-dose group Ingredients by weight: 90 parts Cornus officinalis, 25 parts Lilium brownii, 25 parts Angelica sinensis, 40 parts Astragalus membranaceus (processed), 40 parts Dendrobium officinale, 25 parts raw malt, 35 parts Rosa rugosa, 40 parts Albizia julibrissin, and 20 parts Panax quinquefolius.

[0038] The preparation processes for the three sets of examples are the same, differing only in the weight proportions of the raw materials. The specific steps are as follows: Medicinal herb pretreatment All raw materials are manually sorted and impurities removed, including mud, sand, insects, mold, rotten parts, and non-medicinal impurities. The surface of the raw materials is rinsed with cool, flowing purified water, and then allowed to air dry naturally at room temperature. The raw materials are then sorted and trimmed, removing the fibrous roots of rhizomes and the remaining petals and stamens of flowers. After trimming, the raw materials undergo triple testing for moisture, impurities, and activity. Raw materials that pass the tests are then classified and sealed for storage. The storage environment is maintained at a temperature between 18 and 25°C and a relative humidity between 45% and 65%, in a cool, clean, and temperature- and humidity-controlled environment.

[0039] Gradient decoction preparation of thick extract The decoction groups are divided according to the heat resistance and volatility of the effective components of the medicinal materials. Cornus officinalis, lily bulb, Angelica sinensis, processed Astragalus membranaceus, Dendrobium officinale, and raw malt are classified as long-decoction group. Rose and Albizia julibrissin are classified as medium-decoction group. American ginseng is classified as short-decoction group.

[0040] Add 8 to 10 times the total weight of purified drinking water to the herbs for long-term decoction, and let them soak in at room temperature for 30 to 40 minutes. First, bring the decoction to a boil over high heat, then maintain the temperature at 90 to 95°C and simmer over low heat in a sealed container for 25 minutes. Maintain a low pressure of 0.01 to 0.05 MPa throughout the decoction process.

[0041] Add the herbs from the middle decoction group, maintain a constant temperature of 90℃, and continue to simmer over low heat in a sealed container for 5 minutes.

[0042] Add the herbs for the short decoction group, lower the temperature to 88℃ or below, simmer over low heat for 3 minutes, then turn off the heat.

[0043] After decoction, filter through an 80-100 mesh medicinal sieve and collect the first decoction. Add 6 times the amount of purified water to the dregs, simmer at 90℃ for 15 minutes, then filter and collect the second decoction. Combine the two decoction filtrates.

[0044] The combined filtrates were concentrated at low temperature in a vacuum negative pressure environment at 60℃ or below to prepare a thick extract of traditional Chinese medicine. The relative density of the thick extract at 60℃ was 1.25 to 1.30.

[0045] Low-temperature pulverization for preparation of raw medicinal powder Take qualified raw materials that are in the same weight ratio as the decoction formula and place them in a gradient low-temperature drying device. Set the drying temperature to 45 to 50℃ and dry for 1.5 to 3 hours. After drying, use a cell wall breaking pulverizer to pulverize the medicinal materials. The pulverized material is then passed through a 110-mesh sieve to obtain the whole-component raw medicinal powder. The raw medicinal powder is stored in a sealed container in a low-temperature, moisture-proof, light-proof, and sterile environment.

[0046] Mixing extracts with medicinal powders to make soft materials The thick extract prepared by low-temperature vacuum concentration and the whole-component raw medicinal powder after cell wall disruption are added to a sterile mixing device at a mass ratio of 1:1.3. The mixture is first stirred at low speed for 20 minutes to achieve initial homogenization, then kneaded at low speed for 10 minutes, with the total stirring time controlled between 30 and 40 minutes. After stirring, a standard pelleting soft material is obtained. The soft material is prepared and used immediately, and stored in a completely sealed, light-proof environment throughout the process.

[0047] Pill Formulation Processing Water pill preparation: Take a small amount of whole-component virgin medicinal powder as a lubricant and molding aid. Put the soft material into the pill-making equipment, process it into uniform strips, and then roll it into pills, controlling the pill diameter to be 3 to 4 mm. After molding, dry at a low temperature gradient of 55 to 60℃ for 2 to 3 hours, controlling the moisture content of the water pills to be no higher than 8.5%.

[0048] Honey pill preparation: First, heat and refine the honey at 118℃, controlling the honey's moisture content to 14% to 16%. Filter to remove impurities and surface foam. Mix the raw medicinal powder with the refined honey at a mass ratio of 1:0.9 to 1.1, and process into large honey pills weighing 3 to 9 grams each. After shaping, place them in a clean, cool environment to air dry naturally, controlling the ambient temperature at 18 to 25℃ and the relative humidity at 40% to 50%, ensuring the moisture content of the honey pills does not exceed 14.0%.

[0049] Quality Inspection and Aseptic Packaging The formed pills are screened and graded using a vibrating screen to remove broken, irregularly shaped, or unevenly sized pills. Qualified pills are then polished using polishing equipment to ensure a smooth surface and uniform color. Quality testing is conducted on the pills, including indicators such as moisture content, weight variation, dissolution rate, retention rate of active ingredients, and volatile oil content. Products meeting all standards are considered qualified. Qualified pills are sealed in sterile pharmaceutical aluminum foil bags or light-proof airtight bottles. The finished product is stored in a cool, dry, and light-proof environment with a constant temperature of 18-25°C and a relative humidity of 45%-65%.

[0050] Three sets of objective effect verification data This validation employed three methods: physicochemical quantitative detection, mouse sedation and tranquilizing pharmacological experiments, and human clinical quantitative scoring. All data were obtained through instrument detection and experimental measurement, without subjective judgment.

[0051] Table 1: Objective Test Data of Physicochemical Quality Testing instruments: High performance liquid chromatograph, gas chromatograph, drug dissolution tester, moisture analyzer; Detection method: Perform three parallel tests and take the average value;

[0052] Table 2: Pharmacological data of sedation and tranquilization experiments in mice Experimental animals: SPF-grade ICR mice, 30 mice per group, administered by gavage for 30 consecutive days; Detection indicators: Sleep onset rate, sleep latency, and sleep duration of subthreshold doses of sodium pentobarbital;

[0053] Table 3: Objective quantitative validation data in human clinical trials Subject population: Sub-healthy individuals with insomnia due to liver and kidney deficiency, liver stagnation and spleen deficiency, 60 cases in each group, who took the medicine continuously for 30 days; Evaluation methods: TCM syndrome quantitative scoring, Pittsburgh Sleep Quality Index, and serum cortisol test; Scoring rules: The more severe the symptoms, the higher the score; a decrease in the score indicates improvement in symptoms.

[0054] Verification conclusions In Example 2, the effective ingredient content, sedative and tranquilizing effect in mice, and clinical improvement effect in humans were all optimal in the medium-dose group, and all indicators met the legal standards and were significantly better than those in the low-dose and high-dose groups. In Example 1, the low-dose group had a low effective ingredient content and weaker pharmacological and clinical effects; in Example 3, the high-dose group had no obvious adverse reactions, no significant improvement in efficacy, and its cost-effectiveness was lower than that of the medium-dose group.

[0055] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0056] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A method for preparing a pill form of a traditional Chinese medicine composition that simultaneously nourishes the liver and kidneys, soothes the liver, strengthens the spleen, calms the mind, and aids sleep, characterized in that... Includes the following steps: In the formulation and compatibility stage, the raw material components of traditional Chinese medicine are prepared. In the pre-processing stage of medicinal materials, the raw materials are sorted, cleaned, drained, and trimmed to remove non-medicinal parts and impurities. After testing the raw materials, qualified raw materials are sealed and stored. In the gradient decoction stage, the decoction groups are divided according to the characteristics of the medicinal materials. The medicinal materials in different groups are decocted in stages, the decoction filtrates are collected and combined, and the concentrated filtrates are used to prepare a thick extract of traditional Chinese medicine. In the powder preparation stage, the pre-treated qualified medicinal materials are dried, pulverized, and sieved to prepare raw medicinal powder, which is then sealed and stored. In the soft material preparation stage, the thick extract and raw medicinal powder are put into a mixing device and mixed to prepare the pelleting soft material; In the dosage form forming stage, the forming and drying processes of water pills or honey pills are carried out to complete the processing and forming of the two dosage forms; During the quality control and packaging stage, the formed pills are screened, polished, and tested for quality. Qualified pills are then aseptically packaged.

2. The method for preparing a pill of a traditional Chinese medicine composition that simultaneously nourishes the liver and kidneys, soothes the liver, strengthens the spleen, calms the mind, and aids sleep, as described in claim 1, is characterized in that... The raw material components in the formulation stage are as follows by weight: 70-90 parts of Cornus officinalis, 15-25 parts of Lilium brownii, 15-25 parts of Angelica sinensis, 20-40 parts of Astragalus membranaceus (processed), 20-40 parts of Dendrobium officinale, 15-25 parts of raw malt, 25-35 parts of Rosa rugosa, 20-40 parts of Albizia julibrissin, and 10-20 parts of Panax quinquefolius.

3. The method for preparing a pill of a traditional Chinese medicine composition that simultaneously nourishes the liver and kidneys, soothes the liver, strengthens the spleen, calms the mind, and aids sleep, as described in claim 2, is characterized in that... In the pretreatment stage of medicinal materials, the raw materials are manually sorted and impurities are removed, including mud, insect-infested parts, moldy parts, rotten parts, and non-medicinal impurities. The raw materials are then rinsed with low-temperature flowing purified drinking water to remove surface dirt. After rinsing, the raw materials are allowed to drain naturally at room temperature. Then, the raw materials are classified and trimmed to remove the fibrous roots of rhizomes and the petals and stamens of flowers. After trimming, the raw materials undergo a triple test for moisture, impurities, and activity. The qualified raw materials are classified, sealed, and stored in a cool, clean, and temperature- and humidity-controlled area with a temperature of 18-25°C and a relative humidity of 45%-65%.

4. The method for preparing a pill of a traditional Chinese medicine composition that simultaneously nourishes the liver and kidneys, soothes the liver, strengthens the spleen, calms the mind, and aids sleep, as described in claim 3, is characterized in that... The gradient decoction stage divides the medicinal materials into three groups based on the differences in heat resistance and volatility of their effective components: a long decoction group, a medium decoction group, and a short decoction group. A three-stage decoction process with separate soaking and micro-pressure (0.01–0.05 MPa) and temperature control is used to prepare the decoction. First, the long decoction group is composed of Cornus officinalis, Lilium brownii, Angelica sinensis, Astragalus membranaceus (processed), Dendrobium officinale, and raw malt. Eight to ten times the volume of purified water is added, and the decoction is soaked for 30–40 minutes at room temperature. After boiling over high heat, the temperature is adjusted to a constant 90–95°C, and the decoction is then simmered over low heat in a sealed container. Boil for 25 minutes; then add the medium decoction group consisting of rose petals and mimosa flowers, maintain a constant temperature of 90℃ and continue to simmer over a sealed fire for 5 minutes, for a total simmering time of 30 minutes. Next, add the short decoction group consisting of American ginseng, lower the temperature to 85-88℃, simmer over a sealed fire for 3 minutes, for a total simmering time of 33 minutes, and then turn off the heat. After simmering, filter the decoction through an 80-100 mesh medicinal sieve to collect the first decoction. Add 6 times the amount of purified water to the remaining dregs, simmer over a sealed fire at 90℃ for 15 minutes, and then filter to obtain the second decoction. Combine the filtrates obtained from the two decoctions.

5. The method for preparing a pill of a traditional Chinese medicine composition that simultaneously nourishes the liver and kidneys, soothes the liver, strengthens the spleen, calms the mind, and aids sleep, as described in claim 4, is characterized in that... The gradient decoction stage involves concentrating the combined filtrate at low temperature in a vacuum negative pressure environment at 60°C or below to obtain a thick extract with a relative density of 1.25 to 1.30 at 60°C.

6. The method for preparing a pill of a traditional Chinese medicine composition that simultaneously nourishes the liver and kidneys, soothes the liver, strengthens the spleen, calms the mind, and aids sleep, as described in claim 5, is characterized in that... In the preparation stage of the medicinal powder, the same weight proportion of pretreated qualified medicinal materials as the decoction formula is taken and placed in a low-temperature hot air circulating oven. The oven is set to a constant temperature of 45-50℃ for 1.5 to 3 hours for drying. After drying, the medicinal materials are pulverized by an ultra-micro airflow pulverizer. The pulverized material is then passed through a 110-mesh sieve to obtain the complete component raw medicinal powder. The raw medicinal powder after pulverization and sieving is sealed and stored in a low-temperature, moisture-proof, light-proof, and airtight container.

7. The method for preparing a pill of a traditional Chinese medicine composition that simultaneously nourishes the liver and kidneys, soothes the liver, strengthens the spleen, calms the mind, and aids sleep, as described in claim 6, is characterized in that... In the soft material preparation stage, the thick extract prepared by low-temperature vacuum concentration and the whole component raw drug powder after cell wall breaking are put into a sterile mixing equipment at a mass ratio of 1:1.

3. First, the materials are stirred at low speed for 20 minutes to complete the initial mixing of materials, and then kneaded at low speed for 10 minutes. After the stirring is completed, the standard soft material for pelleting is obtained.

8. The method for preparing a pill of a traditional Chinese medicine composition that simultaneously nourishes the liver and kidneys, soothes the liver, strengthens the spleen, calms the mind, and aids sleep, as described in claim 7, is characterized in that... In the dosage form forming stage, during the preparation of water pills, a small amount of whole-component raw medicinal powder is selected as a lubricant and forming aid. The prepared soft material is put into the pill-making equipment, processed into uniform pill strips, and then rolled into pills. The pill diameter is controlled to be 3-4 mm. After forming, the pills are dried at a low temperature gradient of 55-60℃ for 2-3 hours, and the moisture content of the pills is controlled to be ≤8.5%. During the preparation of honey pills, the honey is first heated and refined to medium honey with a temperature of 118℃ and a water content of 14%-16%. The impurities and surface foam in the honey are filtered out. Then, the raw medicinal powder and refined honey are kneaded together at a mass ratio of 1:0.9-1.1 and processed into large honey pills of 3-9 g / pill. After forming, the pills are placed in a clean and cool environment at 18-25℃ and a relative humidity of 40%-50% to air dry naturally, and the moisture content of the honey pills is controlled to be ≤14.0%.

9. The method for preparing a pill of a traditional Chinese medicine composition that simultaneously nourishes the liver and kidneys, soothes the liver, strengthens the spleen, calms the mind, and aids sleep, as described in claim 8, is characterized in that... The quality control and packaging stage involves screening and grading the formed pills using a vibrating screen to remove unqualified pills. Qualified pills are then polished using polishing equipment. Subsequently, the formed pills undergo quality testing, with indicators including moisture content, weight variation, dissolution rate, retention rate of active ingredients, and volatile oil content. Products meeting all standards are deemed qualified. Qualified pills are then sealed in sterile pharmaceutical aluminum foil bags or light-proof sealed bottles. The packaged finished product is stored in a cool, dry, light-proof, and constant-temperature environment at a temperature of 18–25°C and a relative humidity of 45%–65%.

10. A traditional Chinese medicine composition that simultaneously nourishes the liver and kidneys, soothes the liver, strengthens the spleen, calms the mind, and aids sleep, prepared by the method described in any one of claims 1-9, characterized in that... It is composed of the following medicinal and edible ingredients in parts by weight: 70-90 parts Cornus officinalis, 15-25 parts Lilium brownii, 15-25 parts Angelica sinensis, 20-40 parts Astragalus membranaceus (processed), 20-40 parts Dendrobium officinale, 15-25 parts raw malt, 25-35 parts rose, 20-40 parts Albizia julibrissin, and 10-20 parts American ginseng.

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