Composition with effects of soothing liver and regulating qi and preparation method thereof

Abstract

The invention provides a composition with effects of soothing liver and regulating qi and a preparation method of the composition, the traditional Chinese medicine composition comprises functional components and auxiliary material components, the functional components are traditional Chinese medicine components, and the auxiliary material components are traditional Chinese medicine components. The traditional Chinese medicine composition mainly comprises the following raw materials in parts by mass: 2-8 parts of rose, 2-8 parts of chrysanthemum, 2-8 parts of astragalus membranaceus, 2-8 parts of platycodon grandiflorum, 5-15 parts of honeysuckle, 5-15 parts of oyster, 5-15 parts of poria cocos, 5-15 parts of fingered citron, 5-15 parts of radix angelicae, 2-8 parts of mint, 2-8 parts of pericarpium citri reticulatae, 2-8 parts of peach kernel, 5-15 parts of angelica sinensis, 10-20 parts of dandelion, 10-20 parts of jasmine, 10-20 parts of semen raphani, 2-8 parts of turmeric, 5-15 parts of citron and 10-20 parts of semen cassiae. The auxiliary material component is prebiotic isomaltooligosacharide, and the mass ratio of the prebiotic isomaltooligosacharide to the traditional Chinese medicine component is 1: (4-19). The composition is subjected to traditional Chinese medicine extraction, double-effect concentration, biological enzymolysis-filtration synergy, mixing and blending with prebiotic isomaltooligosacharide, homogenization, constant volume filling, sterilization packaging and other processes to prepare the oral liquid, and the oral liquid has the effects of soothing liver-qi stagnation, promoting qi to activate blood and removing stasis and dissipating binds.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition having liver-soothing and qi-regulating effects and a preparation method thereof. Background Art

[0002] In modern society, factors such as fast-paced lifestyles, high-intensity work pressure, and complex interpersonal relationships have caused people's emotions to fluctuate frequently, and their spirits are in a state of tension and anxiety for a long time. People in the workplace often feel anxious and stressed in their daily work, and these negative emotions are closely related to a variety of health problems. Long-term mental stress can cause disorders in the human endocrine system, and the liver, as an important metabolic and detoxification organ in the human body, is the first to be affected.

[0003] According to TCM theory, the liver is responsible for regulating qi and regulating the flow of qi. When the mood is not smooth, it is easy to cause liver qi stagnation, which in turn affects the circulation of qi and blood throughout the body and the coordination of the functions of the internal organs. Liver qi stagnation has various clinical manifestations, such as depression, chest or lower abdominal distension and pain, and sighing. Modern medical research also shows that the liver depression caused by emotional stress is closely related to the occurrence and development of digestive system diseases (such as gastric ulcers, indigestion), cardiovascular system diseases (such as hypertension, coronary heart disease) and nervous system diseases (such as insomnia, anxiety). At present, the treatment methods for liver depression-related diseases mainly include Western medicine and TCM treatment. Although Western medicine has a certain effect in relieving symptoms, it often has problems such as large side effects and easy recurrence. At present, antidepressants can cause adverse reactions such as dizziness, drowsiness, and gastrointestinal discomfort, and withdrawal symptoms are prone to occur after long-term use. Traditional Chinese medicine has a long history and rich experience in soothing the liver and regulating qi. Chinese medicine compositions have gradually attracted attention for their advantages of overall conditioning and small side effects.

[0004] There are many traditional Chinese medicine prescriptions for soothing the liver and regulating qi, but there are certain limitations in the form of preparations and ease of use. Most traditional prescriptions need to be decocted by oneself, which is a cumbersome process, time-consuming, and not suitable for modern fast-paced life. Moreover, the traditional decoction method will lead to unstable extraction of active ingredients of the medicine due to factors such as differences in the quality of medicinal materials and different decoction conditions, thus affecting the efficacy. In addition, some commercially available Chinese patent medicines are relatively fixed in formula, which makes it difficult to meet the individual differences and complex medical conditions of different patients. Most of the products with conditioning functions currently on the market are insufficient in terms of the scientific nature of the formula, the significance of the efficacy, and safety, and it is difficult to effectively solve a series of problems caused by liver qi stagnation. Summary of the invention

[0005] The purpose of the present invention is to provide a composition and a preparation method which is safe, has few side effects and has significant liver-soothing and qi-regulating effects, and can effectively improve various sub-health symptoms caused by liver qi stagnation.

[0006] Provided is a composition with the efficacy of soothing the liver and regulating qi. In the formula of this composition, various traditional Chinese medicine ingredients cooperate with each other to produce a synergistic effect. With traditional Chinese medicine as the core and combined with modern preparation technology, it is made into an oral liquid that is convenient to take, overcoming the limitations of traditional Chinese medicine such as cumbersome decoction and unstable extraction of active ingredients, and meeting people's needs for convenient and efficient health care products. Among them, honeysuckle, dandelion, and gardenia can clear heat and detoxify, and can clear away the heat pathogen generated by the liver depression transforming into fire; peach kernels, angelica, and turmeric promote blood circulation and remove blood stasis. When used together with qi-regulating drugs, they treat both qi and blood, improve the blood stasis state caused by liver qi stagnation, and enhance the therapeutic effect on symptoms such as irregular menstruation and stabbing pain in the chest and hypochondrium; oyster, poria, and cassia seed soothe the liver and suppress yang, promote diuresis and remove dampness, and clear the liver and improve eyesight, comprehensively regulating the body functions, synergistically improving various problems such as endocrine disorders and eye discomfort caused by liver depression, and enhancing the overall efficacy of the composition; rose, chrysanthemum, mint, fingered citron, and citron fruit and other medicinal materials have the effect of soothing the liver and regulating qi, can directly regulate the problem of liver qi stagnation, restore the normal dispersing and discharging function of the liver, make the qi mechanism smooth, relieve symptoms such as emotional depression and distending pain in the chest and hypochondrium, reflecting the profound understanding of the physiology and pathology of the liver and the principle of syndrome differentiation and treatment in traditional Chinese medicine, and fundamentally solving a series of problems caused by liver depression; platycodon grandiflorum disperses lung qi and benefits the throat, regulates the lung qi. The lung governs qi and the liver governs dispersion and discharge, and the two coordinate with each other to promote the smooth flow of qi throughout the body; astragalus membranaceus supplements qi, and angelica sinensis nourishes blood. Qi and blood generate each other, providing a material basis for the normal function of the liver and all internal organs of the body; dried tangerine peel and radish seed regulate qi and strengthen the spleen, promote digestion and relieve flatulence, protect the acquired foundation of the spleen and stomach, ensure the source of qi and blood generation, make the functions of the body's internal organs coordinate with each other, maintain the stability of the internal environment, reflect the holistic concept of traditional Chinese medicine, and enhance the body's ability to resist diseases and self-repair.

[0007] A composition with the efficacy of soothing the liver and regulating qi provided by the present invention comprises an active ingredient group and an auxiliary ingredient group. The active ingredient group is composed of traditional Chinese medicine ingredients, mainly including the following raw materials in parts by mass: 2 - 8 parts of rose, 2 - 8 parts of chrysanthemum, 2 - 8 parts of astragalus membranaceus, 2 - 8 parts of platycodon grandiflorum, 5 - 15 parts of honeysuckle, 5 - 15 parts of oyster, 5 - 15 parts of poria, 5 - 15 parts of fingered citron, 5 - 15 parts of angelica dahurica, 2 - 8 parts of mint, 2 - 8 parts of dried tangerine peel, 2 - 8 parts of peach kernel, 5 - 15 parts of angelica sinensis, 10 - 20 parts of dandelion, 10 - 20 parts of gardenia, 10 - 20 parts of radish seed, 2 - 8 parts of turmeric, 5 - 15 parts of citron fruit, and 10 - 20 parts of cassia seed. The auxiliary ingredient group is prebiotic isomaltooligosaccharide, and the mass ratio of the prebiotic isomaltooligosaccharide to the traditional Chinese medicine ingredients is 1:4 - 9.

[0008] The functions of each ingredient in the composition with the efficacy of soothing the liver and regulating qi of the present invention are as follows: Rose: It has the efficacy of soothing the liver and relieving depression, promoting blood circulation and relieving pain, can regulate emotions, and improve problems such as distending pain in the chest and hypochondrium caused by liver qi stagnation. Its fragrance also has a certain effect of soothing emotions.

[0009] Chrysanthemum: Clearing the liver and improving eyesight, calming the liver yang, it can clear and purge the liver fire, relieve symptoms such as red and swollen eyes and dizziness caused by the flaring up of liver fire, and assist the liver in maintaining normal dredging and blood storage functions.

[0010] Astragalus membranaceus: Tonifying qi and ascending yang, strengthening the exterior and consolidating the superficies, it can enhance the vital qi of the body, improve the body's resistance and immunity, help improve the unsmooth qi and blood and physical weakness caused by liver depression, and promote the generation and circulation of qi and blood.

[0011] Platycodon grandiflorum: Dispelling pathogenic factors from the lung and relieving sore throat, eliminating phlegm and discharging pus, it can regulate the dispersing and descending of lung qi. The lung and the liver are interrelated in qi movement regulation. By regulating lung qi, it indirectly assists the dredging of liver qi, making the qi movement of the whole body smoother.

[0012] Honeysuckle flower: Clearing heat and detoxifying, dispersing wind-heat, it can clear the heat toxin in the body, has a certain cleaning effect on the heat pathogen accumulation in the body caused by liver depression transforming into fire or emotional discomfort, and can also prevent the symptoms of getting angry caused by liver depression.

[0013] Oyster: Calming the mind with heavy substances, suppressing yang and nourishing yin, softening hardness and dissipating nodules, it helps to calm the mind, relieve emotional problems such as anxiety and insomnia. Its function of softening hardness and dissipating nodules is helpful for eliminating possible nodules or stasis in the body, and synergistically improves the state of liver depression with other drugs.

[0014] Poria cocos: Promoting diuresis and excreting dampness, strengthening the spleen and calming the heart, it can dispel dampness in the body, enhance the function of the spleen and stomach. When the spleen and stomach function well, qi and blood are abundantly generated, providing an adequate material basis for the normal function of the liver. At the same time, calming the heart and soothing the mind helps to relieve the impact of emotional fluctuations on the heart.

[0015] Buddha's hand: Soothing the liver and regulating qi, harmonizing the stomach and relieving pain, it can directly act on the liver, enhance the effect of soothing the liver and relieving depression, and can also regulate the spleen and stomach, improve symptoms such as epigastric discomfort and loss of appetite caused by liver depression invading the stomach, and promote the normal operation of digestive function.

[0016] Angelica dahurica: Relieving exterior syndrome and expelling cold, dispelling wind and relieving pain, opening the nasal orifices, drying dampness and arresting leukorrhea, draining pus and detumescence, its function of dispelling wind and relieving pain can relieve the pain in the head or other parts of the body caused by liver qi stagnation, improve the discomfort symptoms of the body to a certain extent, and promote the smooth circulation of qi and blood.

[0017] Mentha haplocalyx: Dispelling wind-heat, clearing the head and eyes, relieving sore throat and promoting eruption, soothing the liver and regulating qi, it has an obvious effect of soothing the liver, can effectively disperse the stagnant liver qi, and its cool property can also relieve the discomfort in the head caused by emotional tension, making people feel refreshed and comfortable.

[0018] Tangerine peel: Regulating qi and strengthening the spleen, drying dampness and resolving phlegm, it can enhance the transportation and transformation function of the spleen and stomach, regulate the ascending and descending of qi movement, eliminate phlegm dampness caused by spleen qi stagnation, help keep the internal environment of the body fresh, and promote the dredging of liver qi and the circulation of qi and blood throughout the body.

[0019] Peach kernel: It can promote blood circulation, remove blood stasis, improve problems such as irregular menstruation and dysmenorrhea caused by liver depression and blood stasis, and at the same time, it can expel old stool and toxins from the body and reduce the burden on the body.

[0020] Angelica: It replenishes blood and promotes blood circulation, regulates menstruation and relieves pain, and moistens the intestines and promotes bowel movements. It can not only replenish the blood that may be lost due to liver depression and poor blood circulation, but also promote blood circulation, regulate the menstrual cycle, and improve various gynecological problems caused by liver depression and blood deficiency in women. The bowel-moistening and laxative effect is similar to that of peach kernels, and it helps the body detoxify.

[0021] Dandelion: clears away heat and detoxifies, reduces swelling and resolves nodules, promotes dampness and relieves stranguria. It can remove heat toxins and dampness from the body, and has a good effect on liver depression transforming into fire, internal accumulation of dampness and heat, etc. Its effect of reducing swelling and resolving nodules helps to dissipate nodules or lumps that may appear in the body.

[0022] Gardenia: It can relieve fire and relieve restlessness, clear away heat and dampness, cool blood and detoxify. It can effectively clear away liver fire and heart fire, and relieve symptoms such as irritability, insomnia and dreaminess caused by liver depression and fire. The diuretic effect can help drugs such as Poria cocos to expel moisture from the body and maintain the body's water metabolism balance.

[0023] Radish seeds: They help with digestion, relieve bloating, reduce qi and resolve phlegm. They can promote gastrointestinal motility, aid digestion, and eliminate problems such as abdominal distension and hiccups caused by liver depression affecting the stomach or food stagnation. The effects of reducing qi and resolving phlegm help clear the respiratory tract, keep breathing unobstructed, and make the whole body's qi more coordinated.

[0024] Turmeric: It can break up blood and promote the flow of Qi, relieve pain by unblocking meridians, and enhance the effect of promoting blood circulation and removing blood stasis. It has a good effect on improving problems such as pain and meridian obstruction caused by liver depression and blood stasis, promotes the circulation of Qi and blood in the meridians, and relieves various discomforts of the body.

[0025] Citron: Soothes the liver and regulates qi, relieves fullness and resolves phlegm, and has similar effects to bergamot. It mainly regulates liver depression and qi stagnation and spleen and stomach qi stagnation, enhances the effect of regulating qi, improves symptoms such as chest and flank distension, stomach discomfort, and promotes smooth qi flow in the body.

[0026] Cassia seed: Clears the liver and improves eyesight, moistens the intestines and promotes bowel movements. It can clear liver fire and improve symptoms such as dryness, redness and swelling of the eyes. Moistening the intestines and promoting bowel movements help excrete toxins from the body, reduce the liver's detoxification burden, and maintain the normal function of the liver.

[0027] Prebiotic isomaltooligosaccharide: As an auxiliary material, it regulates intestinal flora and improves the intestinal microecological environment. The intestine and liver are closely related in physiological functions. A good intestinal environment helps the liver's detoxification and metabolic functions, promotes the absorption and utilization of nutrients, and enhances the body's overall health level. It also helps to improve the absorption and utilization efficiency of other drug ingredients in the composition.

[0028] The preparation method of the composition with the efficacy of soothing the liver and regulating qi prepares a variety of traditional Chinese medicine raw materials carefully and adopts a suitable extraction process to obtain the active ingredients. Then, the extract is further optimized through steps such as double-effect concentration, bioenzymatic hydrolysis-filtration synergy, etc. It is then rationally mixed and formulated with prebiotic isomaltooligosaccharide, homogenized, volume-fixed and filled, and sterilized and packaged to finally produce an oral liquid product. This not only fully exerts the synergistic effects of soothing the liver and regulating qi and other effects of each traditional Chinese medicine ingredient, but also overcomes the cumbersome traditional Chinese medicine decoction and unstable ingredient extraction problems with the help of modern preparation technologies, improving the product quality and stability. At the same time, the addition of prebiotics helps to regulate the intestinal flora and promote drug absorption, providing people with a safe, efficient and convenient health care product, which is of great significance for improving sub-health symptoms caused by liver qi stagnation.

[0029] The present invention provides a preparation method of a composition with the efficacy of soothing the liver and regulating qi, specifically including the following steps: S1 Traditional Chinese medicine extraction: Prepare the raw materials according to the specified weight parts, including 2-8 parts of rose, 2-8 parts of chrysanthemum, 2-8 parts of astragalus membranaceus, 2-8 parts of platycodon grandiflorum, 5-15 parts of honeysuckle, 5-15 parts of oyster, 5-15 parts of poria cocos, 5-15 parts of fingered citron, 5-15 parts of angelica dahurica, 2-8 parts of mint, 2-8 parts of dried tangerine peel, 2-8 parts of peach kernel, 5-15 parts of angelica sinensis, 10-20 parts of dandelion, 10-20 parts of gardenia jasminoides, 10-20 parts of radish seed, 2-8 parts of turmeric, 5-15 parts of citron, 10-20 parts of cassia seed. Perform extraction operations on the above traditional Chinese medicine raw materials, add ethanol or water as the solvent, and adopt extraction processes such as decoction method, maceration method, reflux method, percolation method, etc. to fully obtain the active ingredients in the medicinal materials; the specified weight parts of the raw materials ensure that the proportions of each traditional Chinese medicine in the composition are appropriate, can play a synergistic role, and achieve effects such as soothing the liver and regulating qi. The different dosage ranges of 2-8 parts of rose, 5-15 parts of honeysuckle, etc. are determined through research and practice to ensure that the content of their active ingredients in the final product is appropriate, which can not only achieve the therapeutic effect but also avoid affecting the overall efficacy due to excessive or insufficient dosage of a certain medicine; the selection of ethanol or water as the solvent and different extraction processes such as decoction method, maceration method, reflux method, percolation method, steam distillation method, and steam distillation method combined with maceration method are determined according to the properties of the medicinal materials and the characteristics of the active ingredients. The decoction method is used for platycodon grandiflorum, astragalus membranaceus, poria cocos, etc. because their active ingredients can be better dissolved under hydrothermal conditions; while the maceration method is used for rose, chrysanthemum, etc. because ethanol can better extract their volatile or lipophilic components, and various active ingredients in the medicinal materials can be fully obtained, improving the quality and efficacy of the extract.

[0030] S2 Double-effect Concentration: After vacuum freeze-concentrating the extracted solution, it is subjected to vacuum evaporation. The vacuum degree is controlled between -0.08 MPa and -0.09 MPa, and the water in the solution is rapidly evaporated at 60 - 70 °C until the concentrated solution reaches a relative density of 1.05 - 1.20; during vacuum freeze-concentration, the solution is cooled to -20 °C to -30 °C, and slow stirring at 20 - 50 revolutions per minute can gradually freeze the water into ice crystals, preventing the active ingredients from being damaged due to excessive local temperature or violent stirring during concentration and ensuring their activity; subsequently, under the conditions of 60 - 70 °C and a vacuum degree of -0.08 MPa to -0.09 MPa, vacuum evaporation can quickly remove water, making the concentrated solution reach a relative density of 1.05 - 1.20. This relative density range is conducive to the subsequent process, ensuring the stable quality of the product, and at the same time is beneficial to the preservation of active ingredients and the formation of preparations.

[0031] S3 Bioenzymatic Hydrolysis-Filtration Synergy: By preparing a composite enzyme solution containing cellulase, pectinase, amylase, and lipase in a mass ratio of 1 - 4:1 - 3:1 - 2:2 - 1, after enzymatic hydrolysis of the double-effect concentrated traditional Chinese medicine extract, a multi-stage filtration technology is adopted to remove impurities, insoluble particles, macromolecular substances, etc. in the solution to obtain a relatively clear filtrate; preparing the composite enzyme solution in a mass ratio of 1 - 4:1 - 3:1 - 2:2 - 1 is for the macromolecular substances such as cellulose, pectin, starch, and fat in the traditional Chinese medicine extract. Selecting appropriate proportions of cellulase, pectinase, amylase, and lipase for enzymatic hydrolysis can decompose these macromolecules and release more active ingredients, improving the medicinal effect; adding glycerol and Tween-80 and preparing and storing the composite enzyme solution in a low-temperature environment of 4 - 10 °C. Glycerol can play a role in protecting the enzyme, Tween-80 helps the enzyme disperse in the solution, and the low-temperature environment can maintain the activity of the enzyme. Enzymatic hydrolysis is carried out at 45 - 55 °C and a pH value of 4.5 - 5.0 for 3 - 8 hours. These suitable action conditions of the enzymes can ensure the full progress of the enzymatic hydrolysis reaction; the multi-stage filtration technology uses a 5 - 10 μm filter screen or filter paper for primary filtration, a 0.001 - 0.1 μm ultrafiltration membrane for ultrafiltration, and a 0.22 - 0.45 μm microporous filter membrane for fine filtration to gradually remove impurities, insoluble particles, and macromolecular substances in the solution, obtaining a clear filtrate, improving the product purity, preventing impurities from causing adverse effects on the human body, and at the same time ensuring that the active ingredients pass through the filtration smoothly and enter the subsequent process.

[0032] S4 Mixing and Blending: Mix and blend the filtered filtrate with prebiotic isomaltooligosaccharide in a mass ratio of 1:4 - 9. During the blending process, maintain stirring at 50 - 100 revolutions per minute for 20 - 35 minutes to ensure that the isomaltooligosaccharide is completely dissolved and uniformly mixed with the filtrate, forming a homogeneous mixture; the filtrate and prebiotic isomaltooligosaccharide are mixed in a mass ratio of 1:4 - 9 to ensure that while the prebiotic plays a role in regulating the intestinal flora and other functions in the composition, it does not affect the efficacy of the active ingredients of traditional Chinese medicine, and they can synergistically promote absorption; stirring at 50 - 100 revolutions per minute for 20 - 35 minutes makes the isomaltooligosaccharide completely dissolve and uniformly mix with the filtrate, forming a homogeneous and stable mixture, ensuring the consistency of product quality and enabling each portion of the product to meet the expected therapeutic effect and quality standards.

[0033] S5 Homogenization: Use a high-pressure homogenizer to homogenize the blended mixture under the action of 20 - 80 MPa, and the number of homogenization times is 1 - 3 times; homogenizing the high-pressure homogenizer 1 - 3 times under 20 - 80 MPa can further refine the particles in the mixture, making the distribution more uniform, improving the stability and taste of the product, preventing precipitation or stratification during storage, ensuring the stability of product quality within the validity period, and also facilitating the absorption and utilization of active ingredients by the human body.

[0034] S6 Volume Fixing and Filling: Add distilled water or purified water as a solvent to perform volume fixing on the homogenized solution to make the solution reach the specified volume, and fill the volume-fixed solution into packaging containers such as glass bottles and plastic bottles. The filling volume per bottle is 25 - 50 milliliters; adding distilled water or purified water for volume fixing ensures that the concentration of active ingredients in each bottle of product is accurately consistent, enabling the accurate dosage for each patient's intake. The filling volume per bottle is 25 - 50 milliliters, which meets the dosage standard for general oral liquids, facilitating patient use and also facilitating standardized operation and quality control during the production process.

[0035] S7 Sterilization and Packaging: Use methods such as moist heat sterilization, irradiation sterilization, or filtration sterilization to sterilize the filled product, and use methods such as carton packaging or plastic film packaging to package the sterilized oral liquid to obtain an oral liquid product prepared from a composition with the efficacy of soothing the liver and regulating qi; moist heat sterilization at 100 - 121 °C for 15 - 60 minutes, irradiation sterilization at 5 - 25 kGy, 0.22 μm or 0.45 μm microporous filter membrane, 0.2 - 0.4 MPa, 5 - 15 L / h for filtration sterilization can effectively kill the microorganisms in the product, ensure the safety of the product during storage and use, and prevent product deterioration or harm to the human body caused by microbial contamination; carton packaging or plastic film packaging plays a role in protecting the product, facilitating storage and transportation, and can also provide relevant information about the product, facilitating patient identification and use.

[0036] In the traditional Chinese medicine extraction process in step S1 of the preparation method of the composition of the present invention, appropriate extraction methods are carefully selected according to the characteristics of different medicinal materials. For platycodon grandiflorum, astragalus membranaceus, etc., the decoction method is used to fully extract their active ingredients under hydrothermal conditions; for rose, chrysanthemum, etc., the maceration method is used to extract volatile or fat-soluble components; for honeysuckle, gardenia jasminoides, etc., the reflux method is used to ensure the dissolution of active ingredients; for oyster, peach kernel, etc., the percolation method is used for stable extraction; for mint, the distillation method is used to obtain volatile oil, and for fingered citron, citron, the special distillation combined with maceration method is used for comprehensive extraction; through precise parameter control, such as water volume, ethanol concentration, time, speed, etc., to ensure the maximum extraction and retention of active ingredients, while avoiding excessive impurities or damage to active ingredients. Finally, all the extracts are combined to provide a high-quality, complete-component and appropriately proportioned raw material basis for the subsequent preparation of the composition with a significant effect of soothing the liver and regulating qi, improving the curative effect and stability of the product.

[0037] Preferably, the extraction process of traditional Chinese medicine in step S1 specifically includes the following operations: Weigh 2-8 parts of rose, 2-8 parts of chrysanthemum, 2-8 parts of astragalus membranaceus, 2-8 parts of platycodon grandiflorum, 5-15 parts of honeysuckle flower, 5-15 parts of oyster, 5-15 parts of poria cocos, 5-15 parts of fingered citron, 5-15 parts of angelica dahurica, 2-8 parts of mint, 2-8 parts of dried tangerine peel, 2-8 parts of peach kernel, 5-15 parts of angelica sinensis, 10-20 parts of dandelion, 10-20 parts of gardenia jasminoides, 10-20 parts of radish seed, 2-8 parts of turmeric, 5-15 parts of citron, 10-20 parts of cassia seed; among them, the extraction of platycodon grandiflorum, astragalus membranaceus, poria cocos, angelica sinensis, angelica dahurica, and dandelion adopts the decoction method, the extraction of rose, chrysanthemum, and dried tangerine peel adopts the maceration method, the extraction of honeysuckle flower, gardenia jasminoides, and cassia seed adopts the reflux method, the extraction of oyster, peach kernel, turmeric, and radish seed adopts the percolation method, the extraction of mint adopts the steam distillation method, and the extraction of fingered citron and citron adopts the steam distillation method combined with the maceration method; the decoction method includes: after washing and chopping the medicinal materials, add 6-12 times the amount of water, soak for 30 minutes to 1 hour, then heat to boiling and keep it in a slightly boiling state for 1-2 hours, filter and collect the filtrate after decoction, decoct the residue for a second time, and combine the two filtrates after repeating the operation; the maceration method includes: after crushing the medicinal materials, macerate with 60%-90% ethanol, and the amount of ethanol should be appropriate to submerge the medicinal materials, soak for 36-48 hours, stir regularly during the period, and filter to obtain the filtrate after maceration; the reflux method includes: place the medicinal materials in a reflux device, add 60%-80% ethanol as the solvent, and the amount of ethanol is 8-10 times the amount of the medicinal materials, heat to make the solvent boil and keep it in a reflux state for 1-3 hours, cool and filter after reflux to obtain the filtrate; the percolation method includes: after crushing the medicinal materials, percolate with 70%-80% ethanol or water as the solvent, control the percolation speed at 1-3 ml / min / kg of the medicinal materials, collect the percolate, and filter to obtain the filtrate; the steam distillation method includes: after crushing the medicinal materials, fill them into 1 / 2-2 / 3 of the volume of the distillation flask, heat the steam generator to make the steam enter the flask to contact the raw materials and carry out the volatile components, and after cooling by the condenser, it flows into the receiver, and collect the distillate to obtain the volatile oil; the steam distillation method combined with the maceration method includes: after crushing the medicinal materials, extract the volatile oil by the steam distillation method, collect the volatile oil for standby, soak the remaining medicinal residues with 60%-70% ethanol for 24-36 hours, filter to obtain the filtrate, and combine the volatile oil and the filtrate; combine and mix all the above-mentioned extracted volatile oil and filtrate to obtain the extracted solution.

[0038] In the preparation method of the composition with the efficacy of soothing the liver and regulating qi in the present invention, in the traditional Chinese medicine extraction process of this step, the specific weight part ranges of different traditional Chinese medicines are determined through research and practice. Its function is to ensure that the proportion of each medicinal material in the composition is appropriate, so that its medicinal effect can be fully exerted, and it can also act synergistically with other medicinal materials to achieve the effects such as soothing the liver and regulating qi, and avoid the imbalance and curative effect of the overall formula caused by too much or too little dosage of a certain medicinal material. Adding an appropriate amount of water in the decoction method is to ensure that there is enough solvent in the decoction process of the medicinal materials to dissolve the active ingredients. Too little water will lead to incomplete extraction of the active ingredients, while too much water will increase the time and energy consumption of subsequent concentration and other processes, and dilute the concentration of the active ingredients; soaking for 30 minutes to 1 hour makes the medicinal materials fully absorb water and become moist, which helps the cells to expand, so that the active ingredients are more easily dissolved into the solvent, improving the extraction efficiency; within the temperature and time range of gentle boiling for 1-2 hours, it can not only ensure the full dissolution of the active ingredients under certain temperature conditions, but also avoid the destruction of the active ingredients or the generation of too many impurities due to too high temperature or too long time; at the same time, decocting the filter residue for a second time and combining the filtrates can further extract the residual active ingredients and improve the utilization rate of the medicinal materials. In the maceration method, according to the properties of medicinal materials such as rose, chrysanthemum, and tangerine peel, ethanol with an appropriate concentration is selected as the solvent. Ethanol with different concentrations has different solubilities for different types of active ingredients. This concentration range can better extract the volatile or fat-soluble active ingredients in these medicinal materials; macerating for 36-48 hours gives enough time for ethanol to fully penetrate into the medicinal material tissues and dissolve the active ingredients, and stirring regularly makes the medicinal materials fully contact with the solvent, promoting the dissolution of the active ingredients and ensuring uniform extraction effect. In the reflux method, ethanol with a concentration of 60-80% and a dosage of 8-10 times can effectively extract the active ingredients in medicinal materials such as honeysuckle, gardenia, and cassia seed, ensuring the extraction efficiency and quality; in the reflux state, the solvent continuously circulates and contacts with the medicinal materials, making the active ingredients continuously dissolve, and maintaining a certain time can ensure relatively complete extraction, but it will not cause too many impurities or destruction of the active ingredients due to too long time. In the percolation method, for medicinal materials such as oyster, peach kernel, turmeric, and radish seed, this solvent concentration and percolation rate can make the active ingredients gradually dissolve under the penetration of the solvent, and can control the rate of the extraction process, ensuring the stability of the extraction effect, and at the same time avoiding incomplete extraction or too many impurities due to too fast speed. In the steam distillation method, filling to 1 / 2-2 / 3 of the volume of the distillation flask ensures that there is enough space for the medicinal materials to fully contact with the steam during the distillation process, so that the volatile components can be smoothly carried out, and at the same time avoiding too much or too little filling of the medicinal materials affecting the distillation effect.In the method for preparing the composition of the present invention, in the steam distillation method combined with the maceration method, volatile oils are first extracted by the steam distillation method to effectively obtain the components in the medicinal materials that are volatile and play an important role in functions such as soothing the liver and regulating qi. These volatile oils have unique pharmacological activities such as regulating emotions and promoting the movement of qi. Collecting and reserving them can ensure their role in the final product. Subsequently, the remaining medicinal residues are macerated with 60%-70% ethanol for 24-36 hours because there are still other active ingredients remaining in the medicinal residues after the extraction of volatile oils. The ethanol at this concentration and the maceration time can further extract some non-volatile active ingredients such as flavonoids and alkaloids. By filtering to obtain the filtrate and combining it with the volatile oils, a comprehensive collection of different types of active ingredients in the medicinal materials is achieved, maximizing the utilization of the medicinal material resources, making the final composition more comprehensive and significant in the efficacy of soothing the liver and regulating qi, and enhancing the therapeutic effect and medicinal value of the product. The extracted volatile oils and the filtrate are combined and mixed to obtain the post-extraction solution, ensuring the integrity of the components and maintaining the stability of the formula. The volatile oils contain the volatile active ingredients of the medicinal materials, such as some terpenoids, phenols and other compounds with special aromas and pharmacological activities. These components play a key role in regulating emotions, promoting blood circulation, regulating qi, etc., while the filtrate contains non-volatile active ingredients such as polysaccharides, flavonoids, alkaloids, etc. Combining the two ensures that various types of active ingredients in the medicinal materials can be completely collected into the final extract, thereby making the medicinal effect of the composition more comprehensive and giving full play to the synergistic effect of each component in aspects such as soothing the liver and regulating qi and regulating the body functions. At the same time, in subsequent preparation processes such as concentration and formulation, the unified post-extraction solution is convenient for standardized operation and quality control. Existing in the form of a complete solution, the proportion and mutual relationship of each component are maintained stable, avoiding product quality fluctuations caused by component separation or loss, ensuring that each batch of products can have consistent efficacy and safety, meeting the requirements of clinical or health care use, and ensuring that users can obtain the expected health improvement effect.

[0039] In the double-effect concentration step in the preparation method of the composition of the present invention, first, the extraction solution is transferred to a vacuum freeze concentration device to cool down and slowly stir to freeze the moisture into ice crystals. Subsequently, the ice crystals are sublimated under a low vacuum degree to achieve preliminary concentration. Utilizing the low-temperature environment and the sublimation principle, the risk of thermal degradation and chemical changes of the active ingredients is greatly reduced, protecting their activity. Then, the preliminary concentrated solution is transferred to a double-effect concentration device, and the remaining moisture is further evaporated to the specified relative density at an appropriate temperature and vacuum degree, which not only efficiently realizes the concentration of the solution but also ensures the quality stability of the concentrated solution, providing a raw material basis with appropriate concentration and quality for subsequent mixing and formulation processes, and playing a key supporting role in the stability of the entire composition preparation process and the product quality.

[0040] Preferably, the double-effect concentration in step S2 specifically includes the following operations: Transfer the solution obtained through the traditional Chinese medicine extraction step to a vacuum freeze-concentration device, turn on the refrigeration system, quickly cool the solution to -20°C to -30°C, slowly stir the solution at a speed of 20 - 50 revolutions per minute, so that the water in the solution gradually freezes into ice crystals; after most of the water in the solution freezes into ice crystals, start the vacuum system, gradually reduce the pressure to 10 - 50 Pa, and make the ice crystals gradually transform into water vapor through sublimation in a vacuum environment and be extracted, achieving preliminary concentration within 2 - 6 hours; after completing the vacuum freeze-concentration, transfer the obtained concentrated solution to a double-effect concentration device, preheat the double-effect concentration device, set the temperature at 60 - 70°C, control the vacuum degree at -0.08 MPa to -0.09 MPa, introduce the concentrated solution into the evaporation chamber of the double-effect concentration device, and further quickly evaporate the remaining water in the solution until the concentrated solution reaches a relative density of 1.05 - 1.20.

[0041] Among them, in the vacuum freeze-concentration stage, cooling to -20°C to -30°C causes the water in the solution to quickly freeze into ice crystals, which helps to achieve the preliminary separation of water and active ingredients. The lower temperature reduces the chemical changes and degradation risks of active ingredients during the concentration process, maintaining their activity and stability; slowly stirring the solution at a stirring speed of 20 - 50 revolutions per minute makes the ice crystals form evenly, preventing local supercooling or overheating phenomena, ensuring that the water can continuously and stably freeze into ice crystals, and at the same time avoiding mechanical damage to the active ingredients in the solution or destroying their structure due to too fast stirring; after the ice crystals are formed, reducing the pressure to a vacuum degree of 10 - 50 Pa creates a vacuum environment conducive to the sublimation of ice crystals. The ice crystals are directly transformed into water vapor and extracted, achieving preliminary concentration, and the sublimation process is relatively gentle, which can further reduce the impact on active ingredients; the concentration time of 2 - 6 hours can not only ensure sufficient time for the water to fully sublimate to achieve the effect of preliminary concentration, but also avoid the increase in equipment energy consumption and potential microbial contamination risks caused by too long time, ensuring the efficiency and safety of the entire concentration process. In the double-effect concentration stage, within the temperature range of 60 - 70°C, the water in the solution quickly evaporates, improving the concentration efficiency and not causing serious denaturation or decomposition of the active ingredients due to high temperature, maintaining the quality of the extract while ensuring the concentration effect; maintaining a vacuum degree of -0.08 MPa to -0.09 MPa helps to lower the boiling point of the solution, enabling the water to quickly evaporate at a lower temperature, further accelerating the concentration speed, reducing the heating time of the active ingredients during the concentration process, and protecting their activity and chemical structure; the relative density of the concentrated solution reaching 1.05 - 1.20 is an important indicator for the smooth progress of subsequent mixing, homogenization and other processes. The concentrated solution with an appropriate relative density can ensure accurate proportions of each component when mixed with other components, stable product quality, and is also beneficial to the physical and chemical stability of the product during storage and use.

[0042] In the bioenzymatic hydrolysis-filtration synergistic step in the preparation method of the composition of the present invention, in the compound enzyme solution preparation step, multiple enzymes are mixed in a specific ratio and glycerol and Tween-80 are added. After stirring at low temperature and adjusting the pH value, it is stored to ensure the activity and stability of the enzyme solution, providing effective catalysis for subsequent enzymatic hydrolysis. During the enzymatic hydrolysis reaction, the compound enzyme solution is added according to the specified ratio and conditions, and the parameters are strictly controlled to specifically decompose macromolecular substances in the traditional Chinese medicine extract, release more active ingredients, and enhance the medicinal effect. The multi-stage filtration technology is applied, from primary filtration, ultrafiltration to fine filtration. By reasonably selecting the filtration medium, controlling the flow rate, pressure, temperature and operating environment, etc., impurities, macromolecules and microorganisms in the solution are gradually removed to obtain a clean and sterile filtrate rich in active ingredients, providing high-quality raw materials for subsequent processes, ensuring the safety and effectiveness of the final product, and improving the product quality.

[0043] Preferably, the bioenzymatic hydrolysis-filtration synergistic step in step S3 specifically includes the following operations: S31 Compound enzyme solution preparation: Mix the enzyme solutions in a ratio of cellulase:pectinase:amylase:lipase = 1-4:1-3:1-2:2-1 by mass. Add glycerol with a final concentration volume ratio of 0.02-0.05% and Tween-80 with a final concentration volume ratio of 0.05-0.1% to the mixed enzyme solution. Slowly stir with a magnetic stirrer or mechanical stirrer for 30-60 minutes in a low-temperature environment of 4-10°C, and then make up the volume with an acetic acid-sodium acetate buffer solution with a pH of 4.5-5.0 and check and adjust the pH value again. The prepared compound enzyme solution is stored in a 4-10°C environment for standby; S32 Enzymatic hydrolysis reaction: In the traditional Chinese medicine extract after double-effect concentration, slowly and evenly add the previously prepared compound enzyme solution stored in a 4-10°C environment according to 10-30% of the extract volume. During the addition process, start the stirring device synchronously, set the stirring speed at 50-100 revolutions per minute, adjust the temperature to 45-55°C and keep it, and carry out enzymatic hydrolysis at a pH value of 4.5-5.0 for 3-8 hours; S33 Filtration treatment: Multistage filtration technology is adopted, including primary filtration, ultrafiltration, and fine filtration processes. A filter screen or filter paper with a pore size of 5 - 10 μm is selected as the primary filtration medium. The solution after the enzymatic hydrolysis reaction is slowly poured into the primary filtration device at a flow rate not exceeding 100 mL / min, and gravity or a certain negative pressure is applied by a suction pump to assist filtration; after primary filtration, the obtained filtrate is transferred to an ultrafiltration device. The pore size of the ultrafiltration membrane is selected to be 0.001 - 0.1 μm, the pressure is maintained at 0.1 - 0.5 MPa, and the pressure is slowly increased through a pressure regulating device, with the amplitude of each pressure increase not exceeding 0.05 MPa. The temperature is maintained at 25 - 35 °C, and the filtrate is circulated through the ultrafiltration membrane module at a flow rate of 30 - 50 L / h by a circulation pump to achieve continuous filtration; the solution after ultrafiltration is further subjected to fine filtration treatment. A microporous filter membrane with a pore size of 0.22 - 0.45 μm is selected, and an aseptic filtration device is used for operation in an aseptic environment. Under gravity filtration, the liquid level height of the feed container is controlled at 10 - 20 cm, and the flow rate of the peristaltic pump is adjusted to 5 - 10 mL / min. After fine filtration, the obtained filtrate is collected in a clean and aseptic container.

[0044] Among them, according to the macromolecular components such as cellulose, pectin, starch and fat present in the traditional Chinese medicine extract, the enzyme solution combination with a ratio of cellulase: pectinase: amylase: lipase = 1-4: 1-3: 1-2: 2-1 can specifically decompose these macromolecules, release the encapsulated or bound effective ingredients, and improve the efficacy of the extract. The synergistic effect of enzymes in different proportions can ensure effective enzymolysis of various types of macromolecular substances, making the effective ingredients in traditional Chinese medicine easier to extract and utilize; glycerol with a final concentration volume ratio of 0.02-0.05% can protect the enzyme in a low temperature environment, prevent the enzyme from being inactivated due to too low temperature or changes in the solution environment, and maintain the activity and stability of the enzyme; Tween-80 with a final concentration volume ratio of 0.05-0.1% is used as a surfactant to help the enzyme to be evenly dispersed in the solution, promote the full contact between the enzyme and the substrate, and improve the efficiency of the enzymatic reaction; the low temperature of 4-10°C can reduce the activity loss of the enzyme, prolong the storage time and use effect of the enzyme, and slow stirring can make the enzyme solution and the added glycerol, Tween-80, etc. fully mixed and uniform, while avoiding the destruction of the enzyme structure due to excessive stirring, ensuring that the prepared complex enzyme solution has stable quality and good activity. At the same time, the acetic acid-sodium acetate buffer with a pH of 4.5-5.0 is used to make up the volume and adjust the pH value. This pH range is a suitable environment for the selected enzyme to exert the best activity, ensuring that the enzymatic reaction can proceed efficiently. The composite enzyme solution of 10-30% of the volume of the extract can ensure that there is enough enzyme to catalyze the decomposition of macromolecular substances in the Chinese medicine extract, and can also avoid waste caused by excessive enzyme or adverse effects on subsequent processes, ensuring that the enzymatic hydrolysis reaction achieves the best effect under the premise of economic efficiency; the stirring speed of 50-100 rpm can fully mix the enzyme and the substrate to promote the reaction. Too fast will destroy the enzyme structure. This range can ensure the uniformity and stability of the reaction system; 45-55℃ is the suitable temperature range for the composite enzyme. At this temperature, the enzyme activity is higher and can effectively catalyze the reaction; the pH value of 4.5-5.0 maintains the best active environment of the enzyme, and the enzymatic hydrolysis time of 3-8 hours ensures that the enzyme has enough time to fully act on the substrate, so that the macromolecular substances are fully decomposed and more effective ingredients are released.During the filtration process, a filter screen or filter paper with a pore size of 5 - 10 μm is selected for primary filtration, and the flow rate does not exceed 100 mL / min. The filter screen or filter paper with this pore size can initially remove larger particle impurities and insoluble substances in the solution after the enzymatic hydrolysis reaction. Controlling the flow rate can prevent incomplete filtration or blockage of the filter medium caused by too fast a flow rate, ensuring the effect of primary filtration and providing a relatively clean filtrate for subsequent ultrafiltration. The pore size of 0.001 - 0.1 μm of the ultrafiltration membrane can further retain macromolecular impurities and some colloidal substances in the solution. Precise pressure control and a slow pressure increase method can avoid damage to the ultrafiltration membrane caused by sudden pressure changes, while ensuring the stability and effectiveness of the filtration process. A temperature of 25 - 35 °C helps maintain the stability of the physical and chemical properties of the solution, and an appropriate flow rate can enable the filtrate to fully circulate and filter in the ultrafiltration membrane module, improving the filtration efficiency and quality. Fine filtration can remove tiny particles and microorganisms in the solution, ensuring that the filtrate meets the requirements of sterility and high purity. Operating in a sterile environment prevents secondary contamination. Controlling the liquid level height of the feed container and the flow rate of the peristaltic pump can ensure the stability of the filtration process and the filtration effect, and finally obtain a clean, sterile filtrate with a high content of active ingredients, providing high-quality raw materials for subsequent processes.

[0045] In the preparation method of the composition of the present invention, during the mixing and blending process, the filtered traditional Chinese medicine filtrate and prebiotic isomaltooligosaccharide are mixed step by step according to a specific mass ratio. In the first step, the filtrate is slowly poured in at a moderate speed and an equal amount of prebiotic is added continuously within a short time while stirring, so that the two are initially evenly contacted and fused, avoiding uneven local concentration. In the second step, the stirring speed is increased and the remaining prebiotic is quickly added and then stirring continues to ensure that the prebiotic is completely dissolved and fully mixed with the filtrate to form a homogeneous system, thereby ensuring that the active ingredients of the traditional Chinese medicine and the prebiotic can synergistically play their roles in the final product, maintaining the effects such as soothe the liver and regulate qi of the traditional Chinese medicine, and at the same time promoting drug absorption and improving the intestinal environment by means of the prebiotic to regulate the intestinal flora, enhancing the overall quality and therapeutic effect of the product.

[0046] Preferably, the mixing and blending in step S4 includes the following operations: Weigh the filtered filtrate and prebiotic isomaltooligosaccharide in a mass ratio of 1:4 - 9, and conduct step-by-step mixing and blending. The first-step mixing includes: Slowly and steadily pour the weighed filtrate into the stirring tank, stir at a speed of 50 - 80 revolutions per minute, and evenly add prebiotic isomaltooligosaccharide with the same mass as the filtrate into the stirring tank within 3 - 5 minutes, and continue to stir for 10 - 15 minutes. The second-step mixing includes: Increase the stirring speed of the mixed liquid after the first-step mixing to 70 - 100 revolutions per minute, and within the next 3 - 5 minutes, add all the remaining prebiotic isomaltooligosaccharide into the stirring tank, maintain the stirring speed of 70 - 100 revolutions per minute, and continue to stir for 10 - 15 minutes to obtain a homogeneous mixed liquid.

[0047] Among them, the mass ratio of 1:4 - 9 is determined through research. While ensuring that the prebiotic isomaltooligosaccharide plays roles such as regulating the intestinal flora in the composition, it cooperates with the active ingredients in the traditional Chinese medicine filtrate to achieve the best synergistic effect. It will neither affect the efficacy of the traditional Chinese medicine components due to excessive prebiotic content nor fail to fully exert its auxiliary effect due to too low content. In the first mixing operation, the filtrate is slowly poured in at a relatively moderate stirring speed and an equal amount of prebiotic is added in a short time, so that the prebiotic is initially evenly dispersed in the filtrate, avoiding local high concentration or agglomeration caused by too fast stirring or adding, ensuring the uniformity and stability when the two start to mix, laying a foundation for subsequent full mixing. At the same time, enough time is given for the filtrate and prebiotic to fully contact and initially fuse at this stirring speed, enabling the prebiotic to gradually dissolve and interact with the components in the filtrate, promoting the homogeneity and stability of the mixing system and ensuring good initial mixing effect. In the second mixing operation, the stirring speed is increased and the remaining prebiotic is added in a short time to accelerate the dissolution and dispersion of the remaining prebiotic, making it more quickly incorporated into the mixed solution, further improving the mixing efficiency and uniformity. Continuous stirring ensures that all prebiotics are completely dissolved and form a uniform mixed solution with the filtrate, making the component distribution in the whole system uniform, ensuring the consistency and stability of the product quality, and providing raw materials with stable quality for subsequent processes.

[0048] In the homogenization step of the preparation method of the composition of the present invention, the fluidity of the prepared mixed solution is improved by preheating; the feeding flow rate and the discharging temperature are controlled to ensure the stability of the homogenization process and the product quality, and prevent damage to the active ingredients due to too high temperature; a relatively high working pressure is set and homogenization is carried out multiple times. The shearing force and impact force generated by the high pressure are used to fully refine and evenly disperse the particulate matter in the mixed solution, enhancing the stability and consistency of the product; finally, it is collected into a pre-cleaned and disinfected container, avoiding external contamination, ensuring the purity and safety of the product, providing a high-quality raw material basis for subsequent processes such as constant volume filling, and playing a key role in improving the quality of the final product.

[0049] Preferably, the homogenization in step S5 specifically includes the following operations: using a high-pressure homogenizer for the prepared mixed solution, preheating the mixed solution at 30 - 50 °C, controlling the feeding flow rate at 10 - 30 L / h, controlling the discharging temperature at 30 - 60 °C, setting the working pressure at 20 - 80 MPa, setting the number of homogenization times at 1 - 3 times, and collecting it into a pre-cleaned and disinfected container after the homogenization treatment is completed.

[0050] Among them, preheating the mixture at 30 - 50°C helps to reduce the viscosity of the mixture, making the liquid flow more easily during the subsequent high-pressure homogenization process, improving the homogenization efficiency. At the same time, it avoids damaging the active ingredients due to excessive temperature, ensuring the quality and efficacy of the product; an appropriate feeding flow rate ensures that the mixture can stably enter the high-pressure homogenizer, guaranteeing the continuity and uniformity of the homogenization process. Too fast a flow rate will result in too short a residence time of the mixture in the homogenizer, unable to achieve sufficient homogenization, while too slow a flow rate will affect production efficiency and increase production costs; controlling the discharge temperature is to prevent the mixture temperature from being too high due to the heat generated during the high-pressure homogenization process, thereby avoiding thermal degradation or denaturation of the active ingredients. A discharge temperature of 30 - 60°C is conducive to maintaining the physical and chemical stability of the product, ensuring product quality; the working pressure is set at 20 - 80 MPa, and the high-pressure homogenizer can apply sufficient shear force and impact force to the mixture, further refining the particulate matter therein to reach a nanoscale or smaller particle size, thus making the product more uniform and stable; multiple homogenizations further improve the uniformity and stability of the mixture. As the number of homogenization times increases, the degree of refinement and distribution uniformity of the particles will be improved, but too many homogenization times will increase equipment wear and production costs, so it needs to be optimized and selected according to the actual situation; ensuring the cleaning and disinfection of the collection container prevents external microorganisms or impurities from contaminating the homogenized product, guaranteeing the sterility and purity of the product, and meeting the quality standards and hygiene requirements of pharmaceutical production.

[0051] In the volume-fixing and filling step of the preparation method of the composition of the present invention, the packaging container is first subjected to strict cleaning and sterilization treatments. Glass bottles and plastic bottles are respectively treated by specific chemical reagents, temperatures, times, irradiation, etc., effectively removing impurities and killing microorganisms, providing a sterile storage environment for the product, and preventing contamination and deterioration; then, in the volume-fixing operation, the homogenized solution is accurately transferred and the volume-fixing error is strictly controlled, ensuring that the concentration of the active ingredients in each bottle of product is consistent, and ensuring the stability of the product quality; finally, during the filling operation, the filling volume is adjusted according to the standard and the sealing is ensured to be good, which not only meets the dosage requirements of the product for the convenience of patients, but also avoids the influence of external factors on the product, guaranteeing the stability and safety of the product during storage and transportation, and playing a key role in the quality control of the entire product.

[0052] Preferably, the volume-fixing and filling in step S6 specifically includes the following operations: S61 Container Processing: Clean the packaging containers and sterilize the containers after cleaning. For glass bottles, soak them in a 1-2% sodium hydroxide solution at 60-70°C for 30-40 minutes, then rinse with clean water until neutral, then rinse with distilled water or purified water, and finally perform high-pressure steam sterilization at 121°C for 15-20 minutes. For plastic bottles, first rinse them with deionized water, then soak them in a 75% ethanol solution for 10-15 minutes, and finally sterilize them by ultraviolet irradiation or gamma-ray irradiation with an irradiation dose of 20-30 kGy. Store them in a clean environment for later use after sterilization; The sodium hydroxide solution has strong alkalinity and can effectively remove oil stains, impurities and microorganisms on the surface of glass bottles. Soaking at 60-70°C for 30-40 minutes ensures the cleaning effect and at the same time avoids damaging the glass bottles due to too high temperature or too long soaking time; Rinsing with clean water until neutral and subsequent rinsing ensure the removal of residual sodium hydroxide solution, prevent it from having an adverse effect on the product, and ensure the chemical stability and safety of the product; High-pressure steam sterilization at 121°C for 15-20 minutes can completely kill the remaining microorganisms on the glass bottles, meet the aseptic requirements, provide a clean and aseptic storage environment for the product, and prevent the product from deteriorating due to microbial contamination during storage; Deionized water can remove dust and some soluble impurities on the surface of plastic bottles. The 75% ethanol solution can disinfect and sterilize. Soaking for 10-15 minutes ensures the disinfection effect and will not have an excessive impact on the plastic bottle material; Ultraviolet irradiation or gamma-ray irradiation sterilization further ensures that the plastic bottles reach the aseptic state. The irradiation dose of 20-30 kGy is within the safe and effective range, which can kill microorganisms and will not cause obvious physical or chemical changes to the plastic bottles, ensuring their integrity and stability.

[0053] S62 Volume Fixing Operation: Transfer the homogenized solution to a cleaned and calibrated volumetric flask or volume fixing tank to ensure the cleanliness and accuracy of the container, and avoid affecting the product concentration and quality due to container contamination or volume error; Slowly add distilled water or purified water for volume fixing to prevent the solution from splashing or mixing unevenly; The volume error of the solution after volume fixing is controlled within ±0.5%. Strictly controlling the volume error can ensure that the content of the active ingredient in each bottle of product is accurately consistent, making the product quality stable and reliable, and meeting the quality standards and medication requirements.

[0054] S63 Filling Operation: According to the product requirements, adjust the filling volume of the filling machine to 25-50 ml, which meets the dose standard designed for the product, is convenient for patients to use, and is also convenient for standardized operation and quality control during the production process to ensure that the dose of each bottle of product is accurate; Turn on the filling machine and fill the volume-fixed solution into the sterilized glass bottles or plastic bottles to ensure good sealing, prevent the product from contacting the external environment during storage and transportation, avoid microbial contamination, moisture loss or other impurities from entering, ensure the stability and quality of the product, and extend the shelf life of the product.

[0055] In the sterilization packaging step of the preparation method of the composition of the present invention, through various sterilization treatment methods such as moist heat sterilization, irradiation sterilization, and filtration sterilization, according to their respective operation requirements, such as the regulations on product placement, temperature, time, and steam release for moist heat sterilization, the requirements for plastic bottles and dosage for irradiation sterilization, and the settings for microporous membrane, pressure, and flow rate for filtration sterilization, it effectively kills the microorganisms in the product, ensures the sterility and safety of the product, and prevents problems such as deterioration caused by microbial growth; while the carton or plastic film packaging operation provides physical protection for the product, facilitates the storage, transportation, and sales of the product, and also helps to maintain the stability of the product. Finally, an oral liquid product with the efficacy of soothing the liver and regulating qi that meets the quality standards is successfully obtained, ensuring the health and medication safety of users.

[0056] Preferably, the sterilization packaging in step S7 specifically includes sterilization treatment and packaging operation. Among them, the sterilization treatment includes moist heat sterilization, irradiation sterilization, and filtration sterilization. Moist heat sterilization includes: placing the filled product on the tray or hanging basket of the sterilizer, with a gap of not less than 2 - 3 cm between products, setting the temperature of the high-pressure steam sterilizer between 100 - 121 °C, the sterilization time being 15 - 60 minutes. After sterilization, slowly release the steam. After the pressure drops to zero, then open the sterilizer to take out the product; Irradiation sterilization includes: the filled product should use a specific plastic bottle with good tolerance to irradiation, and the dosage of irradiation sterilization is between 5 - 25 kGy; Filtration sterilization includes: selecting a microporous membrane filter with a pore size of 0.22 μm or 0.45 μm, connecting the filled product to the filter through a sterile pipeline, using a pressure filtration method, with a pressure of 0.2 - 0.4 MPa, and adjusting the flow rate between 5 - 15 L / h. The filtered product should be directly collected into a sterilized packaging container; The packaging operation includes carton packaging or plastic film packaging to obtain an oral liquid product prepared from a composition with the efficacy of soothing the liver and regulating qi.

[0057] Among them, during moist heat sterilization, the gap between products should be no less than 2 - 3 cm to ensure that steam can circulate fully between products, enabling each product to be evenly heated, avoiding incomplete sterilization of local areas due to over - dense product stacking, and ensuring the consistency of sterilization effect; sterilizing at 100 - 121 °C for 15 - 60 minutes can effectively kill bacteria, spores and other microorganisms in the product. Different microorganisms have different tolerances to temperature and time. This parameter setting ensures that common pathogenic microorganisms can be completely inactivated, while avoiding adverse effects on the quality of the product and the packaging container caused by too high temperature or too long time; releasing steam slowly and opening the sterilizer after the pressure drops to zero can prevent the product from boiling violently or the packaging container from being damaged due to a sudden drop in pressure, ensuring the integrity and stability of the product after sterilization and ensuring that the product quality is not affected. During irradiation sterilization, specific plastic bottles with good radiation tolerance are used to ensure that the plastic bottles will not degrade, deform or release harmful substances during irradiation, guaranteeing the integrity and safety of the product packaging, and at the same time maintaining the quality stability of the product; the irradiation dose of 5 - 25 kGy has been verified to be able to effectively kill microorganisms, while avoiding damage to the active ingredients of the product or causing other adverse changes due to too high irradiation dose, ensuring the efficacy and quality of the product. For filtration sterilization, a microporous membrane filter with a pore size of 0.22 μm or 0.45 μm is selected, which can effectively intercept bacteria and other microorganisms and prevent them from entering the final product, ensuring the sterility of the product, while allowing the active ingredients and solvents in the product to pass through, ensuring that the quality and performance of the product are not affected; a pressure of 0.2 - 0.4 MPa and a flow rate of 5 - 15 L / h ensure the smooth progress of the filtration process, preventing the filter membrane from rupturing due to too high pressure or the filtration effect from being poor due to too fast flow rate, ensuring the effectiveness and stability of filtration sterilization. During packaging operation, carton packaging provides certain mechanical protection to prevent the product from being physically damaged such as being collided or squeezed during transportation and storage, and at the same time is convenient for printing product information and labels; plastic film packaging has good moisture - proof and barrier properties, which can further protect the product from the influence of external environmental factors, extend the shelf life of the product, and ensure that the product maintains a good quality state before use.

[0058] The uniqueness and advantages of the composition and preparation method of the present invention in aspects such as medicinal material selection, extraction process, concentration and formulation, sterilization and packaging, etc. These factors work together to significantly improve the effects of soothing the liver and regulating qi, stability, safety, etc. of the product of the present invention.

[0059] In summary, the present invention has the following beneficial effects: 1. Compared with traditional prescriptions, in the formula of the present invention, multiple traditional Chinese medicine components cooperate with each other to produce a synergistic effect, and the precise dosage ranges of each medicinal material are determined based on modern research and practice. It can effectively soothe the liver and relieve depression, promote qi and activate blood circulation, eliminate stasis and disperse nodules, and improve various sub-healthy symptoms such as emotional depression, chest and hypochondrium distending pain, irregular menstruation, and insomnia caused by stagnation of liver qi. It fundamentally regulates the liver function, the overall qi and blood circulation of the body, and the coordination of zang-fu organs, overcoming the deficiencies of traditional prescriptions in dealing with complex diseases and individual differences; 2. Compared with conventional oral liquids and other products, the present invention combines traditional Chinese medicine with modern preparation technologies. Using prebiotic isomaltooligosaccharide as an adjuvant to regulate the intestinal flora, improve the intestinal microecological environment, promote the liver's detoxification and metabolic functions, as well as the absorption and utilization of nutrients, while improving the absorption efficiency of other drug components in the composition, enhancing the overall health level of the body, and synergistically acting with the traditional Chinese medicine components to improve the overall therapeutic effect of the product; 3. Compared with traditional or conventional preparation methods, in the preparation method of the present invention, for the extraction of traditional Chinese medicine, appropriate extraction processes are selected according to the characteristics of different medicinal materials to ensure the full extraction of effective components; in the subsequent preparation process, through steps such as double-effect concentration, biological enzymolysis-filtration coordination, mixing and blending, homogenization, constant volume filling, and sterilization packaging, the product quality and stability are improved, solving the problems of cumbersome decoction of traditional Chinese medicine, unstable extraction of effective components, fixed formulas of commercially available Chinese patent medicines, and insufficient efficacy and safety; 4. Different from the traditional single extraction method, the present invention adopts various extraction processes such as decoction method, maceration method, reflux method, percolation method, steam distillation method and the combination of steam distillation method and maceration method for different medicinal materials, and precisely controls parameters such as water volume, ethanol concentration, time, and speed to extract the active ingredients in the medicinal materials to the greatest extent, avoiding excessive impurities or damage to the active ingredients; in the double-effect concentration step, vacuum freeze concentration and vacuum evaporation are innovatively combined. Low temperature makes the water crystallize and sublimate to reduce the risk, and then it is stably concentrated under suitable conditions to ensure the quality of the raw materials; different from the conventional filtration means of traditional Chinese medicine extracts, the present invention adopts a biological enzymolysis-filtration synergistic technology, prepares a compound enzyme solution according to a specific ratio to decompose macromolecular substances in the traditional Chinese medicine extract, releases more active ingredients, and at the same time gradually removes impurities, macromolecules and microorganisms through multi-stage filtration technology to ensure the quality of the filtrate; the filtrate and prebiotic oligo-isomaltose are mixed step by step according to a specific mass ratio. By controlling the stirring speed and time, it is ensured that the prebiotic is completely dissolved and evenly mixed with the filtrate, so that the active ingredients of traditional Chinese medicine and the prebiotic play a synergistic role, regulate the intestinal flora, promote drug absorption and improve the intestinal environment, improve the overall quality and therapeutic effect of the product, and overcome the problem of uneven mixing of components in the conventional dispensing method; when homogenizing, preheat the mixed solution, precisely control the feeding flow rate, discharge temperature, working pressure and homogenization times, use high pressure to refine particles and disperse them evenly, enhance stability, prevent precipitation and stratification, ensure that the active ingredients are not damaged, improve the product quality, and optimize the traditional process; different from the traditional rough filling method, the present invention strictly cleans and sterilizes the packaging containers before filling, precisely transfers the homogenized liquid, strictly controls the fixed volume error, regulates the filling volume standardly and ensures good sealing, ensures that the concentration of the active ingredients of the product is consistent and meets the dosage requirements, prevents pollution and deterioration, and ensures stable and safe storage and transportation, making up for the defects of traditional filling; at the same time, it overcomes the deficiencies of traditional products in sterilization and packaging. Adopt various methods and operate according to regulations, combined with carton or plastic film packaging to ensure aseptic safety, facilitate storage, transportation and sales, maintain product stability, and overcome the drawbacks of traditional sterilization packaging; 5. The composition with the efficacy of soothing the liver and regulating qi of the present invention is made into an oral liquid form, which is convenient for patients to take and adapts to the modern fast-paced life. Compared with taking traditional Chinese medicine after decoction or some solid dosage form drugs, it improves the medication compliance of patients, provides a convenient health care product for people, and helps to improve the sub-healthy symptoms caused by liver qi stagnation. Detailed implementation method

[0060] This specific embodiment is only an explanation of the present invention, and it is not a limitation of the present invention. Those skilled in the art can make modifications to this embodiment without creative contributions according to needs after reading this specification, but as long as they are within the scope of the claims of the present invention, they are protected by the patent law.

[0061] Example 1

[0062] This embodiment provides a composition with the efficacy of soothing the liver and regulating qi, including an active ingredient component and an excipient component. The active ingredient component is a traditional Chinese medicine ingredient, mainly including the following components in parts by weight: 5 parts of rose, 5 parts of chrysanthemum, 5 parts of astragalus membranaceus, 5 parts of platycodon grandiflorum, 10 parts of honeysuckle flower, 10 parts of oyster, 10 parts of poria cocos, 10 parts of fingered citron, 10 parts of angelica dahurica, 5 parts of mint, 5 parts of dried tangerine peel, 5 parts of peach kernel, 10 parts of angelica sinensis, 15 parts of dandelion, 15 parts of gardenia jasminoides, 15 parts of radish seed, 5 parts of turmeric, 10 parts of citron, and 15 parts of cassia seed. The excipient component is prebiotic isomaltooligosaccharide, and the mass ratio of prebiotic isomaltooligosaccharide to the traditional Chinese medicine ingredient is 1:6.

[0063] The above composition is prepared according to the following method: S1 Traditional Chinese medicine extraction: The above traditional Chinese medicine raw materials are subjected to extraction operations, adding ethanol or water as a solvent, and through extraction processes such as decoction method, maceration method, reflux method, percolation method, etc., to fully obtain the active ingredients in the medicinal materials; S2 Double-effect concentration: The extracted solution is concentrated by reduced-pressure evaporation, and the vacuum degree is controlled at -0.085 MPa to rapidly evaporate the water in the solution at 65 °C until the concentrated solution reaches a relative density of 1.15; S3 Biological enzymolysis-filtration coordination: A composite enzyme solution containing cellulase, pectinase, amylase, and lipase is prepared according to a mass ratio of 3:2:1:1, and after enzymolysis reaction on the traditional Chinese medicine extract after double-effect concentration, a multi-stage filtration technology is used to remove impurities, insoluble particles, macromolecular substances, etc. in the solution to obtain a relatively clear filtrate; S4 Mixing and blending: The filtered filtrate and prebiotic isomaltooligosaccharide are mixed and blended according to a mass ratio of 1:6, and stirring is maintained during the blending process to ensure that isomaltooligosaccharide is completely dissolved and uniformly mixed with the filtrate to form a uniform mixture; S5 Homogenization: The blended mixture is homogenized by a high-pressure homogenizer under the action of 50 MPa; S6 Volume fixing and filling: Distilled water or purified water is added as a solvent, and the homogenized solution is subjected to volume fixing operation to make the solution reach the specified volume, and the volume-fixed solution is filled into packaging containers such as glass bottles and plastic bottles, and the filling amount per bottle is 50 milliliters; S7 Sterilization and packaging: The filled product is sterilized by methods such as moist heat sterilization, irradiation sterilization, or filtration sterilization, and the sterilized oral liquid is packaged by methods such as carton packaging or plastic film packaging to obtain an oral liquid product prepared from a composition with the efficacy of soothing the liver and regulating qi.

[0064] 100 subjects who voluntarily agreed to receive conditioning were selected. According to their different symptoms, they were symptomatic for chest distending pain, nodules, listlessness, dry mouth, and bitter taste. The following are the typical symptoms of these five types: 1. Chest distending pain The pain is significantly aggravated when there are mood swings, and there is fullness and pain in the chest after getting angry or anxious. The location of the pain is mostly not fixed and may radiate.

[0065] The breast pain intensifies before menstruation, and cord-like or patchy thickened breast tissue can be felt. The symptoms slightly relieve after menstruation.

[0066] There is discomfort in the chest, and a feeling of stuffiness can be felt in the chest when breathing. The symptoms slightly reduce after taking a long sigh.

[0067] Some patients are accompanied by pain in the hypochondrium, which is interrelated with the chest pain.

[0068] 2. Nodules Breast nodules: Round or oval masses can be felt in the breast, with a relatively hard texture and unclear boundaries.

[0069] Thyroid nodules: Nodular masses can be felt in front of the neck and generally move up and down with the swallowing movement.

[0070] Subcutaneous nodules: Nodules of different sizes can be felt under the skin, without obvious tenderness. In a few cases, there is pain or itching.

[0071] 3. Melancholy The mood remains low, the enthusiasm for daily activities of interest is lost, and one often feels sad and empty.

[0072] It is easy to fall into deep thought, repeatedly think about unpleasant things, the attention is difficult to concentrate, and the memory declines.

[0073] The sleep quality is poor, it is difficult to fall asleep or one has many dreams and wakes up easily. One still feels tired and lacks vitality after waking up in the morning.

[0074] The appetite is poor, there is no appetite for food, and the weight may change significantly (increase or decrease) in the short term.

[0075] One is reluctant to communicate with others, likes to be alone, avoids social activities, and responds indifferently to the care and greetings of others.

[0076] 4. Dry mouth There is a feeling of dryness in the mouth, the saliva secretion decreases, and in severe cases, the oral mucosa may crack and ache.

[0077] The feeling of dry mouth cannot be relieved even after drinking water. One wakes up due to dry mouth during night sleep and needs to drink water frequently.

[0078] When eating dry foods such as biscuits and steamed buns, one feels difficulty in swallowing and needs to drink a large amount of water to assist swallowing.

[0079] The tongue coating may become dry and less moist, and even crack.

[0080] 5. Bitter taste in the mouth There is a persistent bitter taste in the mouth, especially in the morning, and the bitter taste is still difficult to eliminate after brushing the teeth and rinsing the mouth.

[0081] It may be accompanied by feelings of nausea and vomiting, and symptoms may be aggravated, especially after eating greasy foods.

[0082] Feeling irritable, easily angered, upset, and prone to insomnia, nightmares and other symptoms.

[0083] Some patients may experience pain or distension in the ribs and yellow urine.

[0084] According to their different symptoms, the above symptoms of chest pain, nodules, depression, dry mouth and bitter taste in the mouth were diagnosed. Approximately 91 subjects had chest pain, 82 had nodules, 73 had depression, 89 had dry mouth and 92 had bitter taste in the mouth.

[0085] The subjects took the prepared oral solution orally, 50 ml each time, twice a day, and it could be eaten directly. They took it for 1 month. Before receiving treatment, the symptoms of each subject were recorded and the number of people with each symptom was counted to verify the conditioning effect on each symptom. The effect evaluation criteria are shown in Table 1.

[0086] Table 1 Evaluation criteria for conditioning efficacy

[0087] The conditioning effect of the composition is shown in Table 2, and the improvement rate reaches 100%, indicating that the composition has a good effect of improving various sub-health symptoms caused by liver qi stagnation, and is worthy of vigorous promotion and application. In addition, during the conditioning process, the trial users did not have any adverse feedback, indicating that the composition obtained by the present invention is safe and has no side effects.

[0088] Table 2 The therapeutic effects of different symptoms of the subjects

[0089] Example 2 Zhang, female, 26 years old, first diagnosed on October 8, 2022. The main symptoms of the patient are chest pain and depression; chest fullness and pain are aggravated when the mood fluctuates, the pain is wandering, the breast pain is obvious before menstruation and cord-like thickened tissue can be touched, which is slightly relieved after the end of menstruation, accompanied by chest tightness and discomfort, and often sighing. The mood continues to be low, lack of interest in activities that were previously enthusiastic, often meditating alone, difficulty concentrating, poor sleep quality, difficulty falling asleep and waking up easily with dreams, fatigue in the morning, and unwillingness to communicate with others. The treatment is an oral solution prepared orally, twice a day, 50mL each time. Among its functional components, Chinese medicinal ingredients include 5 parts of rose, 5 parts of chrysanthemum, 5 parts of astragalus, 5 parts of platycodon, 10 parts of honeysuckle, 10 parts of oyster, 10 parts of tuckahoe, 10 parts of bergamot, 10 parts of angelica, 5 parts of mint, 5 parts of tangerine peel, 5 parts of peach kernel, 10 parts of angelica, 15 parts of dandelion, 15 parts of gardenia, 15 parts of radish seeds, 5 parts of turmeric, 10 parts of citron, and 15 parts of cassia seed; the auxiliary material component is prebiotic oligosaccharide, and the mass ratio of prebiotic oligosaccharide to Chinese medicinal ingredients is 1:5, which is prepared according to the method of Example 1. After taking it for 1 month, the patient came for a review on December 15, 2022, and the symptoms such as chest pain and depression disappeared. In view of the good therapeutic effect, the patient continued to take it for 2 months. Although there was no follow-up examination two months later, when the patient was revisited six months later, he said that he no longer had obvious symptoms of liver-qi stagnation, his living conditions and mood had improved significantly compared to before, and his daily work and social activities had returned to normal.

[0090] Example 3 Mr. Li, male, 35 years old, first diagnosed on March 12, 2023. The main symptoms of the patient are bitter mouth and nodules; long-term bitter taste in the mouth, especially in the morning, difficult to eliminate even after brushing teeth, nausea after eating greasy food, irritability, and yellow urine; nodular masses can be felt in the thyroid area, moving up and down with swallowing. The treatment is an oral solution prepared orally, twice a day, 50 mL each time. Its effective Chinese medicinal ingredients include 3 parts of rose, 3 parts of chrysanthemum, 3 parts of astragalus, 3 parts of platycodon, 8 parts of honeysuckle, 8 parts of oyster, 8 parts of poria, 8 parts of bergamot, 8 parts of angelica, 3 parts of mint, 3 parts of tangerine peel, 3 parts of peach kernel, 8 parts of angelica, 12 parts of dandelion, 12 parts of gardenia, 12 parts of radish seeds, 3 parts of turmeric, 8 parts of citron, and 12 parts of cassia seed; the mass ratio of auxiliary material prebiotic oligosaccharide to Chinese medicinal ingredients is 1:7, and the preparation method is the same as Example 1. After taking it continuously for 1 month, the review on April 18, 2023 showed that the bitter mouth symptom was significantly alleviated, the nausea disappeared, and the size of the thyroid nodules was reduced. Continue to take it for 2 months, and review it two months later. The bitter mouth symptom basically disappeared, and the thyroid nodules were further reduced. After a follow-up visit six months later, there was no recurrence of bitter mouth symptoms, the thyroid nodules remained in a small state, and no other symptoms related to liver qi stagnation appeared.

[0091] Example 4

[0092] Wang, female, 42 years old, the initial diagnosis date is June 5, 2023. The main symptoms of this patient are chest distending pain and dry mouth; the chest will be distended and painful as soon as the mood fluctuates slightly, the pain location is not fixed, the breast distending pain is aggravated before menstruation, the chest tightness is obvious, and it is slightly relieved after taking a long sigh; the mouth is dry, the saliva secretion is extremely small, often wakes up due to dry mouth at night, has difficulty swallowing dry food, and the tongue coating is dry and cracked. The treatment is to take the prepared oral liquid orally, twice a day, 50 mL each time. The traditional Chinese medicine ingredients are 6 parts of rose, 6 parts of chrysanthemum, 6 parts of astragalus membranaceus, 6 parts of platycodon grandiflorum, 12 parts of honeysuckle, 12 parts of oyster, 12 parts of poria cocos, 12 parts of fingered citron, 12 parts of angelica dahurica, 6 parts of mint, 6 parts of tangerine peel, 6 parts of peach kernel, 12 parts of angelica sinensis, 18 parts of dandelion, 18 parts of gardenia jasminoides, 18 parts of semen raphani, 6 parts of turmeric, 12 parts of citron, 18 parts of cassia seed; the mass ratio of prebiotic isomaltooligosaccharide to traditional Chinese medicine ingredients is 1:4. After taking it for 1 month, the reexamination was carried out on July 10, 2023, and the symptoms of chest distending pain and dry mouth were significantly improved. After continuously taking it for 2 months, when reexamined again, the chest distending pain basically disappeared, only slightly uncomfortable when the mood was extremely excited, and the dry mouth symptom was also basically relieved. During the follow-up visit half a year later, the symptoms of chest distending pain and dry mouth did not relapse, and the physical condition was good.

[0093] Example 5

[0094] Zhao, male, 30 years old, the initial diagnosis date is August 20, 2023. The main manifestations are being unhappy and having nodules; the mood is continuously low, not interested in anything, often trapped in negative emotions and unable to extricate oneself, the sleep quality is poor, the appetite is poor, the weight has decreased, and at the same time, thyroid nodules can be felt in the neck and move with swallowing. The treatment is to take the prepared oral liquid orally, twice a day, 50 mL each time. Among them, the traditional Chinese medicine ingredients are 4 parts of rose, 4 parts of chrysanthemum, 4 parts of astragalus membranaceus, 4 parts of platycodon grandiflorum, 10 parts of honeysuckle, 10 parts of oyster, 10 parts of poria cocos, 10 parts of fingered citron, 10 parts of angelica dahurica, 4 parts of mint, 4 parts of tangerine peel, 4 parts of peach kernel, 10 parts of angelica sinensis, 15 parts of dandelion, 15 parts of gardenia jasminoides, 15 parts of semen raphani, 4 parts of turmeric, 10 parts of citron, 15 parts of cassia seed; the mass ratio of prebiotic isomaltooligosaccharide to traditional Chinese medicine ingredients is 1:9. After continuously taking it for 1 month, the reexamination was carried out on September 25, 2023, the mood improved, the sleep and appetite improved to a certain extent, and the thyroid nodules had no obvious change. Continue to take it for 2 months, when reexamined, the mood basically returned to normal, the sleep and appetite recovered, and the thyroid nodules became smaller. During the follow-up visit half a year later, the symptom of being unhappy did not appear again, the thyroid nodules were stable, and no new symptoms of liver qi stagnation appeared.

[0095] Example 6

[0096] Ms. Sun, female, 48 years old, the initial diagnosis date is February 1, 2024. The main symptoms of the patient are chest distending pain and bitter taste in the mouth; after getting angry or anxious, the chest fullness and pain are severe and the radiating pain is obvious, the menstrual cycle is disordered and the breast distending pain before menstruation is unbearable, and the pain often occurs in the hypochondrium; the bitter taste in the mouth is very strong, and it even causes nausea in the morning, the mood is extremely irritable, it is difficult to fall asleep, and the urine has been yellow for a long time. The treatment is to take the prepared oral liquid orally, twice a day, 50 mL each time. The functional traditional Chinese medicine components include 7 parts of rose, 7 parts of chrysanthemum, 7 parts of astragalus membranaceus, 7 parts of platycodon grandiflorum, 13 parts of honeysuckle, 13 parts of oyster, 13 parts of poria cocos, 13 parts of fingered citron, 13 parts of angelica dahurica, 7 parts of mint, 7 parts of dried tangerine peel, 7 parts of peach kernel, 13 parts of angelica sinensis, 17 parts of dandelion, 17 parts of gardenia jasminoides, 17 parts of radish seed, 7 parts of turmeric, 13 parts of citron, 17 parts of cassia seed; the mass ratio of the auxiliary prebiotic isomaltooligosaccharide to the traditional Chinese medicine components is 1:8, and the preparation process refers to Example 1. After taking it continuously for 1 month, a reexamination was carried out on March 5, 2024. The symptoms of chest distending pain and bitter taste in the mouth were significantly relieved, the breast distending pain before menstruation was reduced, the mood was relatively stable, and the sleep quality was improved. After continuing to take it for 2 months and reexamining again, the symptoms of chest distending pain and bitter taste in the mouth basically disappeared, and the menstrual cycle gradually became regular. During the follow-up visit half a year later, the above obvious liver qi stagnation symptoms did not appear again, and the physical and emotional states were good.

[0097] Example 7

[0098] Mr. Zhou, male, 38 years old, the initial diagnosis date is May 10, 2024. The main symptoms are nodules and being listless; the thyroid nodules in the neck are relatively obvious, with a strong sense of foreign body when swallowing, and at the same time, the mood is low, lacking enthusiasm for work and life, often being in a daze alone, having memory loss, having many dreams and being easy to wake up during sleep, having a poor appetite, and a slight weight loss. The treatment is to take the prepared oral liquid orally, twice a day, 50 mL each time. The traditional Chinese medicine components are selected as 5 parts of rose, 5 parts of chrysanthemum, 5 parts of astragalus membranaceus, 5 parts of platycodon grandiflorum, 11 parts of honeysuckle, 11 parts of oyster, 11 parts of poria cocos, 11 parts of fingered citron, 11 parts of angelica dahurica, 5 parts of mint, 5 parts of dried tangerine peel, 5 parts of peach kernel, 11 parts of angelica sinensis, 16 parts of dandelion, 16 parts of gardenia jasminoides, 16 parts of radish seed, 5 parts of turmeric, 11 parts of citron, 16 parts of cassia seed; the mass ratio of isomaltooligosaccharide prebiotic to the traditional Chinese medicine components is 1:6. After taking it for 1 month, a reexamination was carried out on June 15, 2024. There was no obvious change in the size of the thyroid nodules, but the mood improved, and the sleep and appetite improved slightly. After continuously taking it for 2 months and reexamining, the thyroid nodules showed a shrinking trend, the mood basically returned to normal, and the sleep and appetite returned to a better state. During the follow-up visit half a year later, the listless symptoms did not appear again, the thyroid nodules remained stable, and no new liver qi stagnation-related symptoms appeared.

Claims

1. A composition having the effect of soothing the liver and regulating qi, characterized in that: The composition comprises functional components and auxiliary components. The functional components are traditional Chinese medicine ingredients, mainly comprising the following raw materials in parts by weight: 2-8 parts of rose, 2-8 parts of chrysanthemum, 2-8 parts of astragalus, 2-8 parts of platycodon, 5-15 parts of honeysuckle, 5-15 parts of oyster, 5-15 parts of poria, 5-15 parts of bergamot, 5-15 parts of angelica, 2-8 parts of mint, 2-8 parts of tangerine peel, 2-8 parts of peach kernel, 5-15 parts of angelica, 10-20 parts of dandelion, 10-20 parts of gardenia, 10-20 parts of radish seeds, 2-8 parts of turmeric, 5-15 parts of citron and 10-20 parts of cassia seeds. The auxiliary component is prebiotic oligosaccharide, and the mass ratio of the prebiotic oligosaccharide to the traditional Chinese medicine ingredients is 1:4-9.

2. A method for preparing a composition having the effect of soothing the liver and regulating qi, characterized in that: The specific steps include: S1 Extraction of Chinese medicine: prepare raw materials according to the prescribed weight proportions, including 2-8 parts of rose, 2-8 parts of chrysanthemum, 2-8 parts of astragalus, 2-8 parts of platycodon, 5-15 parts of honeysuckle, 5-15 parts of oyster, 5-15 parts of poria, 5-15 parts of bergamot, 5-15 parts of angelica, 2-8 parts of mint, 2-8 parts of tangerine peel, 2-8 parts of peach kernel, 5-15 parts of angelica, 10-20 parts of dandelion, 10-20 parts of gardenia, 10-20 parts of radish seeds, 2-8 parts of turmeric, 5-15 parts of citron, and 10-20 parts of cassia seeds, extract the above Chinese medicine raw materials, add ethanol or water as a solvent, and fully obtain the effective ingredients in the medicinal materials through extraction processes such as decoction, maceration, reflux, and percolation; S2 double-effect concentration: The extracted solution is vacuum frozen and concentrated and then evaporated under reduced pressure. The vacuum degree is controlled at -0.08MPa to -0.09MPa, and the water in the solution is evaporated quickly at 60-70℃ until the concentrated solution reaches a relative density of 1.05-1.20; S3 Bio-enzymatic hydrolysis-filtration synergy: A composite enzyme solution containing cellulase, pectinase, amylase and lipase is prepared in a mass ratio of 1-4:1-3:1-2:2-1, and the double-effect concentrated Chinese medicine extract is subjected to enzymatic hydrolysis reaction. Then, multi-stage filtration technology is used to remove impurities, insoluble particles and macromolecular substances in the solution to obtain a relatively clear filtrate; S4 mixing and preparing: the filtered filtrate is mixed with the prebiotic oligosaccharide in a mass ratio of 1:4-9, and the stirring speed is maintained at 50-100 rpm during the preparation process for 20-35 minutes to ensure that the oligosaccharide is completely dissolved and evenly mixed with the filtrate to form a uniform mixed solution; S5 Homogenization: The mixed liquid is homogenized by a high-pressure homogenizer at 20-80 MPa for 1-3 times; S6 fixed volume filling: add distilled water or purified water as solvent, perform fixed volume operation on the homogenized solution to make the solution reach the specified volume, and fill the fixed volume solution into glass bottles, plastic bottles and other packaging containers, with a filling volume of 25-50 ml per bottle; S7 sterilization packaging: sterilize the filled product by wet heat sterilization, irradiation sterilization or filtration sterilization, and package the sterilized oral liquid by paper box packaging or plastic film packaging to obtain an oral liquid product prepared from a composition with the effect of soothing the liver and regulating qi.

3. The method for preparing a composition having liver-soothing and qi-regulating effects according to claim 2, characterized in that: The extraction process of traditional Chinese medicine extraction in step S1 specifically includes the following operations: weigh 2-8 parts of rose, 2-8 parts of chrysanthemum, 2-8 parts of astragalus, 2-8 parts of platycodon, 5-15 parts of honeysuckle, 5-15 parts of oyster, 5-15 parts of poria, 5-15 parts of bergamot, 5-15 parts of angelica, 2-8 parts of mint, 2-8 parts of tangerine peel, 2-8 parts of peach kernel, 5-15 parts of angelica, 10-20 parts of dandelion, 10-20 parts of gardenia, 10-20 parts of radish seeds, 2-8 parts of turmeric, 5-15 parts of citron, and 10-20 parts of cassia seed; wherein the extraction of platycodon, astragalus, poria, angelica, angelica, and dandelion is carried out by decoction. The extraction of rose, chrysanthemum and tangerine peel adopts the immersion method, the extraction of honeysuckle, gardenia and cassia seed adopts the reflux method, the extraction of oyster, peach kernel, turmeric and radish seed adopts the percolation method, the extraction of mint adopts the steam distillation method, and the extraction of bergamot and citron adopts the steam distillation method combined with the immersion method; the decoction method comprises: after washing and chopping the medicinal materials, adding 6-12 times the amount of water, soaking for 30 minutes to 1 hour, heating to boiling and keeping it in a slightly boiling state for 1-2 hours, filtering and collecting the filtrate after decoction, decoct the filter residue for the second time, and combining the two filtrates after repeating the operation; the immersion method comprises: after crushing the medicinal materials, The ethanol is used for soaking, and the amount of ethanol is preferably enough to immerse the medicinal materials. The soaking time is 36-48 hours, and the mixture is stirred regularly during the soaking. After the soaking is completed, the filtrate is obtained by filtering. The reflux method includes: placing the medicinal materials in a reflux device, adding 60-80% ethanol as a solvent, and the amount of ethanol is 8-10 times the amount of the medicinal materials. The solvent is heated to boil and maintained in a reflux state for 1-3 hours. After the reflux is completed, the solvent is cooled and filtered to obtain a filtrate. The percolation method includes: after the medicinal materials are crushed, 70%-80% ethanol or water is used as a solvent for percolation, and the percolation speed is controlled at 1-3 ml / min / kg of medicinal materials, and the percolation liquid is collected, and the percolation liquid is filtered to obtain a filtrate. liquid; the steam distillation method comprises: crushing the medicinal materials and filling them to 1 / 2-2 / 3 of the volume of the distillation flask, heating the steam generator to allow the steam to enter the flask and contact the raw materials to bring out volatile components, cooling through a condenser and then flowing into a receiver, collecting the distillate to obtain volatile oil; the steam distillation method combined with the immersion method comprises: crushing the medicinal materials and extracting volatile oil by steam distillation, collecting the volatile oil for later use, immersing the remaining medicinal residues in 60%-70% ethanol for 24-36 hours, filtering to obtain a filtrate, and combining the volatile oil and the filtrate; combining all the volatile oils and filtrates obtained by the above extractions and mixing them to obtain an extracted solution.

4. The method for preparing the composition having the effect of soothing the liver and regulating qi according to claim 2, characterized in that: The step S2 double-effect concentration specifically includes the following operations: transferring the solution obtained through the Chinese medicine extraction step to a vacuum freeze concentration device, starting the refrigeration system, rapidly cooling the solution to -20°C to -30°C, slowly stirring the solution at a speed of 20-50 rpm, so that the water in the solution gradually freezes into ice crystals; after most of the water in the solution is frozen into ice crystals, starting the vacuum system, gradually reducing the pressure to 10-50Pa, so that the ice crystals are gradually converted into water vapor through sublimation in a vacuum environment and extracted, and preliminary concentration is achieved within 2-6 hours; after completing the vacuum freeze concentration, transferring the obtained concentrated solution to the double-effect concentration device, preheating the double-effect concentration device, setting the temperature at 60-70°C, controlling the vacuum degree at -0.08MPa to -0.09MPa, introducing the concentrated solution into the evaporation chamber of the double-effect concentration device, and further rapidly evaporating the remaining water in the solution until the concentrated solution reaches a relative density of 1.05-1.

20.

5. The method for preparing the composition having the effect of soothing the liver and regulating qi according to claim 2, characterized in that: The step S3 of bio-enzymatic hydrolysis-filtration synergy specifically includes the following operations: Preparation of S31 complex enzyme solution: Mix the enzyme solutions in a mass ratio of cellulase: pectinase: amylase: lipase = 1-4:1-3:1-2:2-1, add glycerol with a final concentration volume ratio of 0.02-0.05% and Tween-80 with a final concentration volume ratio of 0.05-0.1% to the mixed enzyme solution, slowly stir with a magnetic stirrer or mechanical stirrer for 30-60 minutes at a low temperature of 4-10°C, make up the volume with acetic acid-sodium acetate buffer with a pH of 4.5-5.0 and check and adjust the pH value again, and store the prepared complex enzyme solution at 4-10°C for use; S32 enzymatic hydrolysis reaction: slowly and evenly add the previously prepared compound enzyme solution stored at 4-10°C to the double-effect concentrated traditional Chinese medicine extract according to 10-30% of the extract volume. During the addition process, turn on the stirring device at the same time, set the stirring speed at 50-100 rpm, adjust the temperature to 45-55°C and maintain it, and hydrolyze for 3-8 hours at a pH value of 4.5-5.0; S33 Filtration Treatment: Multi-stage filtration technology is used, including primary filtration, ultrafiltration, and fine filtration processes. A filter screen or filter paper with a pore size of 5-10μm is selected as the primary filtration medium. The solution after the enzymatic hydrolysis reaction is slowly poured into the primary filtration device at a flow rate not exceeding 100mL / min. Gravity or a certain negative pressure is applied through a suction pump to assist filtration. After the primary filtration is completed, the filtrate is transferred to the ultrafiltration equipment. The pore size of the ultrafiltration membrane is selected to be 0.001-0.1μm, and the pressure is maintained at 0.1-0.5MPa. The pressure is slowly increased through the pressure regulating device, and the pressure increase amplitude each time is The pressure does not exceed 0.05MPa, the temperature is maintained at 25-35℃, and the filtrate is circulated in the ultrafiltration membrane assembly at a flow rate of 30-50L / h through a circulating pump to achieve continuous filtration; the solution after ultrafiltration is then subjected to fine filtration, and a microporous filter membrane with a pore size of 0.22-0.45μm is selected, and a sterile filtration device is used. The operation is carried out in a sterile environment, and the liquid level of the feed container is controlled at 10-20cm under gravity filtration, and the flow rate of the peristaltic pump is adjusted to 5-10mL / min. After the fine filtration is completed, the filtrate obtained is collected into a clean, sterile container.

6. The method for preparing the composition having the effect of soothing the liver and regulating qi according to claim 2, characterized in that: The mixing and preparing step S4 includes the following operations: weighing the filtered filtrate and prebiotic oligosaccharide in a mass ratio of 1:4-9, and mixing and preparing in steps, the first step of mixing including: slowly and steadily pouring the weighed filtrate into a stirring tank, stirring at a speed of 50-80 rpm, and evenly adding the prebiotic oligosaccharide of the same mass as the filtrate into the stirring tank within 3-5 minutes, and continuously stirring for 10-15 minutes; the second step of mixing includes: increasing the stirring speed of the mixed solution after the first step of mixing to 70-100 rpm, and within the next 3-5 minutes, adding all the remaining prebiotic oligosaccharide into the stirring tank, maintaining the stirring speed of 70-100 rpm, and continuing to stir for 10-15 minutes to obtain a uniform mixed solution.

7. The method for preparing the composition having the effect of soothing the liver and regulating qi according to claim 2, characterized in that: The step S5 homogenization specifically includes the following operations: using a high-pressure homogenizer to preheat the prepared mixed liquid at 30-50°C, controlling the feed flow rate at 10-30L / h, the discharge temperature at 30-60°C, setting the working pressure to 20-80MPa, setting the homogenization times to 1-3 times, and collecting the mixed liquid into a pre-cleaned and disinfected container after the homogenization process is completed.

8. The method for preparing the composition having the effect of soothing the liver and regulating qi according to claim 2, characterized in that: The step S6 of constant volume filling specifically includes the following operations: S61 Container treatment: Clean the packaging containers and sterilize them. Glass bottles are soaked in 1-2% sodium hydroxide solution at 60-70℃ for 30-40 minutes, then rinsed with clean water until neutral, and then rinsed with distilled water or purified water. Finally, they are sterilized by high-pressure steam at 121℃ for 15-20 minutes. Plastic bottles are first rinsed with deionized water, then soaked in 75% ethanol solution for 10-15 minutes, and finally sterilized by ultraviolet irradiation or gamma ray irradiation with an irradiation dose of 20-30kGy. After sterilization, they are stored in a clean environment for use. S62 Volume adjustment operation: transfer the homogenized solution to a cleaned and calibrated volumetric flask or volumetric tank, and slowly add distilled water or purified water to adjust the volume. The error of the solution volume after adjustment should be controlled within ±0.5%; S63 filling operation: According to product requirements, adjust the filling volume of the filling machine to 25-50 ml, turn on the filling machine, and fill the fixed volume solution into the sterilized glass bottle or plastic bottle to ensure a good seal.

9. The method for preparing the composition having the effect of soothing the liver and regulating qi according to claim 2, characterized in that: The sterilization packaging in step S7 specifically includes sterilization treatment and packaging operations, wherein the sterilization treatment includes moist heat sterilization, irradiation sterilization and filtration sterilization. Moist heat sterilization includes: placing the filled product on the tray or hanging basket of the sterilizer, with the gap between the products not less than 2-3 cm, setting the temperature of the high-pressure steam sterilizer between 100-121°C, and the sterilization time is 15-60 minutes. After the sterilization is completed, the steam is slowly released, and after the pressure drops to zero, the sterilizer is opened to take out the product; irradiation sterilization includes: the filled product should be irradiated with a good tolerance to radiation. The specific plastic bottle is irradiated with a dose of 5-25kGy; the filtration sterilization includes: selecting a microporous membrane filter with a pore size of 0.22μm or 0.45μm, connecting the filled product to the filter through a sterile pipeline, using a pressurized filtration method with a pressure of 0.2-0.4MPa and a flow rate adjusted between 5-15L / h, and the filtered product should be directly collected into a sterilized packaging container; the packaging operation includes paper box packaging or plastic film packaging to obtain an oral liquid product prepared from a composition with the effect of soothing the liver and regulating qi.

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