A medicinal and edible homologous traditional Chinese medicine composition with the effects of soothing liver and regulating qi, resolving stasis and resolving mass and a preparation method and preparation thereof

Abstract

This invention discloses a medicinal and edible herbal composition with the effects of soothing the liver and regulating qi, resolving blood stasis and dissipating nodules, as well as its preparation method and formulation, belonging to the technical field of medicinal and edible herbal compositions. The raw materials for preparing this medicinal and edible herbal composition with the effects of soothing the liver and regulating qi, resolving blood stasis and dissipating nodules include: 6-10 parts of dandelion, 5-9 parts of Ampelopsis japonica leaf, 2-6 parts of Citrus medica, 1-3 parts of hawthorn, 1-3 parts of Ficus hirta, 1-3 parts of dried tangerine peel, 1-3 parts of Phragmites communis rhizome, 1-3 parts of rose, and 0.5-2 parts of osmanthus. This medicinal and edible herbal composition has a rigorous formulation, is safe and non-toxic, has a pleasant taste, and a wide range of applications. It has the effects of soothing the liver and regulating qi, resolving blood stasis and dissipating nodules, clearing heat and resolving phlegm, strengthening the spleen and removing dampness, calming the mind and relieving irritability, and can meet the daily conditioning needs of modern people. It is also suitable for industrial production and widespread application.

Description

Technical Field

[0001] This invention belongs to the technical field of traditional Chinese medicine compositions that are both food and medicine, and particularly relates to a traditional Chinese medicine composition that is both food and medicine with the effects of soothing the liver and regulating qi, resolving blood stasis and dissipating nodules, as well as its preparation method and formulation. Background Technology

[0002] With the accelerating pace of industrialization, informatization, and urbanization in modern society, people's pace of life has generally quickened significantly, social competition has intensified, and multiple pressures from work, family, and the economy have continued to accumulate. Against this backdrop, unhealthy lifestyles such as emotional imbalances (e.g., chronic stress, anxiety, depression, excessive thinking), irregular sleep patterns (e.g., staying up late, insufficient sleep, disrupted biological clock), and unhealthy eating habits (e.g., irregular meals, excessive consumption of rich, fatty, cold, or fast food / takeout meals) have become widespread. These factors intertwine, easily leading to abnormal Qi circulation in the body. Firstly, they affect the liver's function of regulating Qi, resulting in liver Qi stagnation; if Qi does not flow smoothly, it further develops into Qi stagnation and blood stasis; simultaneously, liver Qi stagnation affects the spleen, causing dysfunction of the spleen and stomach's digestive system, leading to internal retention of dampness, which accumulates and produces phlegm, ultimately resulting in internal accumulation of phlegm and dampness. This leads to a series of sub-health and pathological conditions, clinically common symptoms include chest and rib pain or radiating pain, frequent sighing, irritability or low mood, abdominal distension, abdominal fullness or discomfort, difficulty falling asleep, frequent dreams and easy awakening, fatigue, heaviness in the head and body, sticky and unsatisfactory stools or loose stools, and menstrual irregularities or premenstrual breast tenderness in women. These symptoms are often a mixture of deficiency and excess, involving dysfunction of multiple organs, and are characterized by chronicity, persistence, and recurrence, causing a continuous negative impact on the patient's quality of life.

[0003] Currently, while there are a certain number of conditioning products on the market targeting the above-mentioned symptoms, they generally suffer from the following shortcomings: First, most product formulas lack rigorous guidance from traditional Chinese medicine theory and do not follow the principle of "principal, assistant, adjuvant, and guide" in their formulation. This makes it difficult for the various ingredients to form an organic synergy, resulting in a relatively singular or untargeted overall efficacy. They often only alleviate some symptoms and fail to achieve the comprehensive conditioning goal of regulating qi and blood, treating the liver and spleen together, and eliminating pathogens without harming the body's vital energy. Second, the products do not fully consider the balance of medicinal properties in their selection and compatibility. Some are biased towards cold (such as using large amounts of Prunella vulgaris, chrysanthemum, and gardenia), which can easily damage the spleen and stomach yang qi with prolonged use, leading to new problems such as poor appetite and diarrhea. Others are biased towards warm and dry (such as using large amounts of dried ginger, cinnamon, and Cyperus rotundus), which can aggravate yin deficiency with long-term use, causing symptoms of "internal heat" such as dry mouth, sore throat, and constipation. These products with obvious biases are not suitable for long-term daily conditioning. Third, in pursuit of rapid effects or cost control, some products add substances that are not "food and medicine of the same origin" or chemically synthesized ingredients, with insufficient safety assessment and potential health risks. At the same time, due to the lack of reasonable taste correction and masking techniques, the products often have obvious bitter, spicy or unpleasant tastes of traditional Chinese medicine, resulting in low taste acceptance. Especially for people who need to take the medicine for a long time, compliance is poor and it is difficult to form a continuous and stable intervention effect.

[0004] In view of this, based on the theory of "medicine and food sharing the same origin" in traditional Chinese medicine, raw materials were selected from the list of substances with "medicine and food sharing the same origin" and the compatibility principle of "principal, assistant, adjuvant, and guide" was strictly followed. Targeting the core pathogenesis of liver qi stagnation, qi stagnation and blood stasis, and phlegm-dampness accumulation, and combined with the physical characteristics of modern people who are "more prone to depression, blood stasis, phlegm, and deficiency", a scientifically formulated, mildly medicinal, moderately hot and cold in nature, palatable, and easy to consume for a long time was developed. It not only has a clear theoretical basis in traditional Chinese medicine and clinical conditioning value, but also meets the urgent needs of modern society for safe, mild, and sustainable health care products. It has important practical significance and market application value in improving sub-health status, preventing related diseases, and improving people's quality of life. Summary of the Invention

[0005] To address the shortcomings of the existing technologies, this paper provides a medicinal and edible herbal composition with the effects of soothing the liver and regulating qi, resolving blood stasis and dissipating nodules, as well as its preparation method and formulation. This medicinal and edible herbal composition has a rigorous formulation, is safe and non-toxic, has a pleasant taste, and is widely applicable. It has the effects of soothing the liver and regulating qi, resolving blood stasis and dissipating nodules, clearing heat and resolving phlegm, strengthening the spleen and removing dampness, calming the mind and relieving irritability. It can meet the daily conditioning needs of modern people and is suitable for industrial production and promotion.

[0006] The primary objective of this invention is to provide a medicinal and edible herbal composition with the effects of soothing the liver and regulating qi, resolving blood stasis and dissipating nodules. By weight, the raw materials for its preparation include: 6-10 parts of dandelion, 5-9 parts of Ampelopsis japonica leaf, 2-6 parts of Citrus medica, 1-3 parts of hawthorn, 1-3 parts of Ficus hirta, 1-3 parts of dried tangerine peel, 1-3 parts of reed rhizome, 1-3 parts of rose, and 0.5-2 parts of osmanthus.

[0007] In some embodiments of the present invention, the dandelion is present in a greater weight than the Ampelopsis japonica leaves.

[0008] This invention strictly adheres to the principles of traditional Chinese medicine regarding the compatibility of principal, assistant, adjuvant, and guide herbs:

[0009] Dandelion is the principal herb in the formula. It possesses the functions of clearing heat and detoxifying, reducing swelling and dissipating nodules, as well as resolving blood stasis, unblocking meridians, and promoting diuresis. It is particularly effective at clearing stagnant heat and turbid toxins from the liver and stomach meridians. Targeting the core pathogenesis of "liver qi stagnation - qi stagnation and blood stasis - phlegm and dampness accumulation" caused by emotional imbalances, irregular diets, and disordered lifestyles in modern people, dandelion can play a leading regulatory role in several key aspects: First, it can clear stagnant heat and "dissipate stagnant qi" (Compendium of Materia Medica), by relieving qi stagnation, it cuts off the mutual adhesion between heat evil and qi stagnation at the source, allowing liver qi to flow smoothly and stagnant heat to be cleared; Second, it has a good effect on resolving blood stasis and unblocking meridians. Its nodule-dissipating function is not only effective for tangible phlegm nodules, scrofula, and mastitis, but also for intangible lumps formed by the mutual binding of qi, blood, and heat. Furthermore, modern pharmacological research has shown that dandelion extract can inhibit inflammation. Firstly, it improves microcirculation and has a positive effect on reducing tissue edema and promoting the dissipation of blood stasis. Secondly, its heat-clearing and detoxifying effects can reduce the phlegm and dampness generated by damp-heat accumulation. At the same time, its ability to promote urination and eliminate dampness guides the existing dampness out through urination, giving phlegm and dampness an outlet. In addition, dandelion enters the stomach meridian, which can clear stomach heat and aid digestion, reducing the chance of food stagnation turning into heat and generating dampness and phlegm. Thirdly, although dandelion is cold in nature, it is sweet in taste. It is cold but not too dry. While clearing heat, it also has a sweet and moistening nature. It can "transform heat toxins" without suddenly damaging the spleen and stomach. As the principal medicine, it can target the core symptoms of heat stagnation and phlegm stasis, while avoiding excessive coldness that damages the body's vital energy. It embodies the safe and mild characteristics of "eliminating evil without harming the body's vital energy".

[0010] Ampelopsis thunbergii leaf is the main ingredient in the entire formula. It has the functions of clearing lung heat and resolving phlegm. It can clear the stagnant heat in the upper jiao (upper burner) of the lungs, resolve the phlegm caused by the stagnation of lung heat, and improve symptoms such as cough, thick yellow phlegm, difficulty in expectorating, sore throat, chest tightness and shortness of breath caused by the obstruction of lung channels by heat and phlegm. At the same time, it is good at clearing the upper jiao, and can soothe the qi mechanism of the upper jiao chest, diaphragm and throat, and clear the deficiency fire and damp heat of the head, face, lungs and stomach. It is especially suitable for the upper jiao heat symptoms such as dry mouth and bitter taste, dry and itchy throat, sores in the mouth and nose, red and dry eyes caused by wind-heat and damp-heat accumulation in the upper jiao. The medicinal properties are mild and moistening without being bitter or cold and damaging to the stomach, clearing heat without damaging yin, and resolving phlegm without drying fluids. Therefore, the leaves of *Ampelopsis japonica*, as the assistant herb, can not only clear lung heat and resolve phlegm, but also unblock the stagnation of Qi in the upper burner. It assists the principal herb in directly targeting the pathogenesis, and works together to clear away heat evil, resolve phlegm and soothe the throat, and promote the flow of lung Qi, so that the heat evil in the upper burner can be cleared, the phlegm turbidity can be resolved, and the Qi mechanism can be soothed.

[0011] Buddha's Hand is the ministerial herb in the whole formula. It mainly enters the Liver and Spleen meridians, and is good at soothing the liver and relieving depression, regulating the flow of liver qi. It can disperse the stagnation of liver qi stagnation, relieve emotional depression, chest and hypochondriac distending pain, chest tightness with frequent sighing, irritability and other symptoms of liver qi stagnation. At the same time, it also has the function of regulating qi and harmonizing the middle, can regulate the qi movement of the spleen and stomach, dredge the stagnation in the middle jiao, and improve the symptoms of abdominal distension, reduced appetite, and abdominal fullness caused by liver qi invading the stomach and qi stagnation. Therefore, as the ministerial herb, Buddha's Hand can assist the sovereign herb to enhance the power of soothing the liver and relieving depression, and at the same time, it can balance the regulation of qi in the middle jiao, prevent liver qi from attacking the spleen and qi stagnation, make the liver qi smooth and the middle qi harmonious, taking both the root and the branch into account, and jointly achieve the effects of soothing the liver and promoting qi movement, relieving depression and harmonizing the middle.

[0012] Hawthorn is the ministerial herb in the whole formula. First, hawthorn is good at promoting blood circulation and removing stasis, can promote the flow of blood vessels, disperse stasis and stagnation, dredge the congestion of qi and blood in the meridians, and resolve the syndrome of internal obstruction of blood stasis in the body. It can help disperse stasis and promote blood circulation, and enhance the power of promoting blood circulation and removing stasis, dissipating stasis and dredging collaterals in the whole formula. Second, hawthorn is good at strengthening the spleen and promoting digestion, especially good at digesting meat and greasy food stagnation. It can strengthen the qi movement of the spleen and stomach, promote appetite and harmonize the middle, dredge the stagnation of food accumulation in the middle jiao, and improve symptoms such as abdominal distension, indigestion of food accumulation, and poor appetite and fullness. It helps the function of the spleen and stomach in transportation and transformation. Therefore, as the ministerial herb, it assists the sovereign herb to enhance the functions of promoting blood circulation to remove stasis and strengthening the spleen and promoting digestion, so that blood stasis can be dispersed, food stagnation can be eliminated, the spleen and stomach can be strengthened, qi and blood are smooth, and the middle jiao is harmonized. Taking both promoting blood circulation to remove stasis and strengthening the healthy qi into account, they complement each other and jointly help the whole formula to take effect.

[0013] Radix Fici Hirta, Tangerine Peel, and Reed Rhizome are the assistant herbs in the whole formula. They closely follow the main functions of the sovereign herb in clearing heat and dissipating stasis, promoting blood circulation and dredging collaterals, and cooperate with the ministerial herbs to enhance the effect of the whole formula. Among them, Radix Fici Hirta strengthens the spleen and removes dampness, replenishes qi and supports healthy qi. It can assist the sovereign herb to resolve phlegm-dampness and stasis, and at the same time, it can tonify qi to help the ministerial herb promote qi and activate blood circulation, so that eliminating pathogenic factors will not damage healthy qi. Moreover, its sweet and neutral nature can restrict the cold nature of the sovereign herb and protect the middle jiao. Tangerine Peel regulates qi and strengthens the spleen, dries dampness and resolves phlegm. It is pungent and warm and disperses, helps the ministerial herb soothe the liver and relieve depression, and promotes qi movement. It also cooperates with the sovereign herb Taraxacum to promote diuresis and resolve phlegm, so that dampness is removed and phlegm is eliminated. At the same time, its warm nature restricts the cold of the sovereign herb, harmonizes the spleen and stomach, and prevents cold from hindering the stomach. Reed Rhizome clears heat and promotes fluid production, removes vexation and tranquilizes the mind. On the one hand, it enhances the power of the sovereign herb in clearing and relieving depression-heat, and supplements the body fluid damaged by heat pathogens. On the other hand, it clears the heart and tranquilizes the mind, aiming at concurrent symptoms such as poor sleep. It assists the ministerial herb to improve the mental symptoms caused by disharmony of qi and blood throughout the body. Moreover, its diuretic function can help the sovereign and ministerial herbs to expel pathogenic factors. Therefore, the three assistant herbs assist the sovereign and ministerial herbs from multiple dimensions of tonifying qi, regulating qi, clearing heat and tranquilizing the mind, making the whole formula have a balanced property of cold and heat, combining tonification and purgation, and being safer and more suitable for long-term use.

[0014] Rose and osmanthus are the guiding herbs in this formula. Rose effectively soothes the liver, regulates qi, and harmonizes blood and qi. It relieves liver stagnation, promotes blood circulation, and alleviates pain, enhancing the liver-soothing and stagnation-relieving effects of the principal and assistant herbs. Simultaneously, it invigorates blood circulation, promotes qi flow, harmonizes qi and blood, and unblocks meridians. It also acts as a guide, directing the other herbs directly to the liver meridian, making the medicinal effects more focused and faster-acting. Osmanthus, with its aromatic properties, invigorates the spleen, warms the middle jiao, and dispels cold. It aids in the healthy functioning of the spleen and stomach, warms and disperses cold stagnation in the middle jiao, and assists the principal and assistant herbs in harmonizing the middle jiao. Its aromatic properties warm and invigorate qi and blood, harmonize the other herbs, and coordinate the overall medicinal properties of the formula, making it mild and balanced, while also improving the taste and palatability. Therefore, these two herbs are used together as guiding herbs: one soothes the liver and guides the other, while the other invigorates the spleen and harmonizes the other herbs. Together, they assist in soothing the liver, regulating qi, warming the middle jiao, and invigorating the spleen, guiding the medicinal effects, and harmonizing the other herbs, thus achieving the overall effect of the formula.

[0015] In summary, the combination of medicinal and edible herbs of the present invention, when used in combination, has the effects of soothing the liver and regulating qi, resolving blood stasis and dissipating nodules, clearing heat and resolving phlegm, strengthening the spleen and removing dampness, and calming the mind and relieving irritability.

[0016] The second objective of this invention is to provide a method for preparing the above-mentioned medicinal and edible herbal composition with the effects of soothing the liver and regulating qi, resolving blood stasis and dissipating nodules, which includes the following steps: weighing the raw materials according to the weight parts, drying, pulverizing, and obtaining the medicinal and edible herbal composition.

[0017] In some embodiments of the present invention, the pulverization process further includes sieving and / or sterilization.

[0018] In some embodiments of the present invention, the sieving includes the step of passing through a 20-60 mesh sieve.

[0019] In some embodiments of the present invention, the sterilization process includes an ultraviolet sterilization step and / or a high-temperature instantaneous sterilization step.

[0020] The second objective of this invention is to provide a preparation with the effects of soothing the liver and regulating qi, and resolving blood stasis and dissipating nodules, which includes the above-mentioned medicinal and edible herbal composition with the effects of soothing the liver and regulating qi, and resolving blood stasis and dissipating nodules.

[0021] In some embodiments of the present invention, the formulation further includes pharmaceutically acceptable excipients or food-acceptable excipients.

[0022] In some embodiments of the present invention, the pharmaceutically acceptable excipients include at least one of diluents, humectants, binders, disintegrants, preservatives, lubricants, surfactants, and penetration enhancers.

[0023] In some embodiments of the present invention, the acceptable excipients in the food include at least one of antioxidants, flavor enhancers, preservatives, sweeteners, thickeners, emulsifiers, stabilizers, and food flavorings.

[0024] In some embodiments of the present invention, the dosage form of the preparation is a tablet, powder, granule or liquid.

[0025] In some embodiments of the present invention, the preparation is a pharmaceutical, health product, or food, and the pharmaceutical, health product, or food may be in the form of tablets, powders, granules, or liquids independently of each other, such as tablet pharmaceuticals, liquid health products, liquid foods, and granular foods. Furthermore, the food includes beverages.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] (1) Scientific and rigorous formulation: The medicinal and food homologous Chinese medicine composition of the present invention has clear distinction between the principal, assistant, adjuvant and guide, and multiple target synergistic effects. It can soothe the liver without harming yin, resolve blood stasis without harming the body's vital energy, remove dampness without being too dry, and clear heat without being too cold.

[0028] (2) Wide range of applicable populations: The medicinal and food homologous Chinese medicine composition of the present invention, which has the effects of soothing the liver and regulating qi, resolving blood stasis and dispersing nodules, is particularly suitable for modern people with liver qi stagnation, blood stasis and phlegm dampness, high stress, emotional distress, weak spleen and stomach, and poor sleep.

[0029] (3) High taste and acceptance: The medicinal and food homologous Chinese medicine composition of the present invention, which has the effects of soothing the liver and regulating qi, and resolving blood stasis and dissipating nodules, is combined with rose and osmanthus flowers. It has a clear and elegant aroma, mellow taste, strong palatability, and is easy to drink for a long time.

[0030] (4) Raw material safety and compliance: The raw materials of the medicinal and food homologous Chinese medicine composition of the present invention with the effects of soothing the liver and regulating qi, resolving blood stasis and dispersing nodules are all medicinal and food homologous substances, new resource foods and ordinary foods. They have no toxic side effects, can be consumed daily for a long time, and meet the relevant national food safety requirements.

[0031] (5) Mature process and industrialization: The preparation process of the medicinal and food homologous Chinese medicine composition of the present invention with the effects of soothing the liver and regulating qi, resolving blood stasis and dispersing nodules is simple, stable and cost controllable. It can be made into a variety of dosage forms such as substitute tea, solid beverage, granules, etc., which is convenient for production, packaging, transportation and sales. It has extremely high industrialization and patent transformation value. Detailed Implementation

[0032] To enable those skilled in the art to better understand the technical solutions of this invention, the technical solutions of this invention will be clearly and completely described below in conjunction with the embodiments of this invention. Obviously, the described embodiments are only some embodiments of this invention, and not all embodiments. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of this invention.

[0033] Unless otherwise specified, all raw materials used in this invention are commercially available.

[0034] Example 1

[0035] This embodiment provides a medicinal and edible herbal composition with the effects of soothing the liver and regulating qi, resolving blood stasis and dissipating nodules. The raw materials for its preparation, by weight, are:

[0036] 8 portions of dandelion

[0037] 7 parts of Ampelopsis japonica leaves

[0038] 4 portions of Buddha's Hand

[0039] 2 servings of hawthorn

[0040] Two portions of Five-Finger Peach

[0041] 2 portions of dried tangerine peel

[0042] 2 portions of reed rhizome

[0043] 2 roses

[0044] One portion of osmanthus flowers;

[0045] Its preparation method is as follows:

[0046] S1. Weigh each raw material according to the formula weight parts, and clean, sort and remove impurities respectively;

[0047] S2. All raw materials are dried in an environment of 45±5℃ to control the moisture content to meet the requirements of food production.

[0048] S3. Crush the dried raw materials separately and pass them through a 40-mesh sieve;

[0049] S4. Add the sieved raw material powders into the mixer according to the formula weight parts, mix thoroughly and evenly to obtain the mixed powder;

[0050] S5. The mixed powder is subjected to ultraviolet sterilization treatment to obtain the medicinal and edible herbal composition with the effects of soothing the liver and regulating qi, resolving blood stasis and dissipating nodules.

[0051] Example 2

[0052] This embodiment provides a medicinal and edible herbal composition with the effects of soothing the liver and regulating qi, resolving blood stasis and dissipating nodules. The raw materials for its preparation, by weight, are:

[0053] 6 portions of dandelion

[0054] 5 parts of Ampelopsis japonica leaves

[0055] 3 portions of Buddha's Hand

[0056] 1 serving of hawthorn

[0057] 1 serving of Five-Finger Peach

[0058] 2 portions of dried tangerine peel

[0059] 3 portions of reed rhizome

[0060] 1 portion of roses

[0061] Two portions of osmanthus flowers;

[0062] The preparation method is the same as in Example 1.

[0063] Example 3

[0064] This embodiment provides a medicinal and edible herbal composition with the effects of soothing the liver and regulating qi, resolving blood stasis and dissipating nodules. The raw materials for its preparation, by weight, are:

[0065] 10 portions of dandelion

[0066] Nine parts of Ampelopsis japonica leaves

[0067] 1 serving of Buddha's Hand

[0068] 2 servings of hawthorn

[0069] 3 portions of Five-Finger Peach

[0070] 1 portion of dried tangerine peel

[0071] 2 portions of reed rhizome

[0072] 3 roses

[0073] Osmanthus flowers, 0.5 parts;

[0074] The preparation method is the same as in Example 1.

[0075] Comparative Example 1

[0076] This comparative example provides a medicinal and edible herbal composition, which differs from Example 1 in that it does not use Ampelopsis thunbergii leaves as the adjuvant, but instead increases the amount of other adjuvants by weight. The raw materials for its preparation are as follows (by weight):

[0077] 8 portions of dandelion

[0078] Buddha's Hand 8.7 portions

[0079] 4.3 servings of hawthorn

[0080] Two portions of Five-Finger Peach

[0081] 2 portions of dried tangerine peel

[0082] 2 portions of reed rhizome

[0083] 2 roses

[0084] One portion of osmanthus flowers;

[0085] The preparation method is the same as in Example 1.

[0086] Comparative Example 2

[0087] This embodiment provides a medicinal and edible herbal composition, which differs from Example 1 in that it does not use reed rhizome as an adjuvant, but instead increases the amount of other adjuvants by weight. The raw materials for its preparation, by weight, are:

[0088] 8 portions of dandelion

[0089] 7 parts of Ampelopsis japonica leaves

[0090] 4 portions of Buddha's Hand

[0091] 2 servings of hawthorn

[0092] 3 portions of Five-Finger Peach

[0093] 3 portions of dried tangerine peel

[0094] 2 roses

[0095] One portion of osmanthus flowers;

[0096] The preparation method is the same as in Example 1.

[0097] The following is an efficacy evaluation of the above-mentioned food-medicine homology traditional Chinese medicine composition.

[0098] 1. Laboratory animals

[0099] Healthy male Kunming mice weighing 28-30g were provided by the Animal Experiment Center of Guangdong Pharmaceutical University.

[0100] 2. Experimental reagents

[0101] Positive group: Xiaoyao San powder

[0102] Experimental group: The medicinal and edible herbal compositions obtained in Examples 1-3;

[0103] Comparative experimental group: The medicinal and edible herbal compositions obtained from Comparative Examples 1 and 2.

[0104] 3. Experimental Methods

[0105] After 7 days of acclimatization, the animals were randomly divided into groups of 6.

[0106] Control group: Normal feeding for 28 days, i.e. no environmental stimulation or intervention in their behavior and diet.

[0107] Other groups: Mice were subjected to tail clamping for 3 minutes (twice a day), stroboscopic illumination (300 flashes / min, 30 min / day), intraperitoneal injection of PCPA (300 mg / kg / day) and carrageenan (10 mg / kg / day), and gavage with 5 wt% rhubarb decoction (0.5 mL / day). Each stimulus was spaced at least 1 hour apart, and the order of each stimulus was not fixed. They were fed a high-fat, high-sugar diet (83.5 wt% basal diet + 5% lard + 5% egg yolk + 5% white sugar + 1.5% cholesterol), fasted for 1 day every other day, and the cages were tilted at 45° during the non-fasting period to create a complex model of liver stagnation-stasis-phlegm-dampness-spleen deficiency. The model was maintained for 28 days.

[0108] In addition, each group received oral administration of 20 mL / kg / day starting from day 1 for 28 days, with at least a 4-hour interval between each oral administration and the aforementioned stimulation. The last oral administration was administered in the last 30 minutes of day 28. The types of medication administered to each group are as follows:

[0109] Control group: physiological saline;

[0110] Model group: physiological saline;

[0111] Positive group: 0.3 g / mL Xiaoyao San dispersion;

[0112] Experimental group 1: 0.3 g / mL of the medicinal and edible herbal composition dispersion obtained in Example 1;

[0113] Experimental group 2: 0.3 g / mL of the medicinal and edible herbal composition dispersion obtained in Example 2;

[0114] Experimental group 3: 0.3 g / mL of the medicinal and edible herbal composition dispersion obtained in Example 3;

[0115] Comparative experimental group 1: 0.3 g / mL of the dispersion of the medicinal and edible herbal composition obtained in Comparative Example 1;

[0116] Comparative Experiment 2: Dispersion of the medicinal and edible herbal composition obtained from Comparative Example 2 with a concentration of 0.3 g / mL.

[0117] 4. Apparent state assessment

[0118] The apparent status of mice in each group was comprehensively evaluated based on factors such as decreased spontaneous activity, increased agitation and cage-catching, slow weight gain, stool shape, fur condition, and tongue coating. Slow weight gain was calculated using the following formula: Weight gain rate = (Post-experiment weight / Pre-experiment weight) × 100%.

[0119] The scoring criteria for each aspect are shown in Table 1.

[0120] Table 1

[0121]

[0122] The results of the apparent status assessment for each group are expressed as the mean score of each group of mice, and the results are shown in Table 2.

[0123] Table 2

[0124]

[0125] As can be seen from the comparison between the model group and the blank group in Table 2, this invention successfully created a composite model of liver stagnation-stasis-phlegm-dampness-spleen deficiency through various behavioral and environmental stimuli. Specifically:

[0126] Reduced spontaneous activity is related to spleen deficiency and liver stagnation. The spleen governs muscles and limbs and is the source of qi and blood. Spleen deficiency leads to insufficient qi and blood, resulting in malnourishment of the limbs, manifesting as fatigue, lethargy, and reduced activity. According to the TCM theory of "liver governing the free flow of qi and blood," it is also related to emotional and behavioral activation.

[0127] Increased restlessness and cage-grabbing in mice are related to liver stagnation and qi stagnation transforming into fire. Impaired liver function and obstructed qi flow can lead to emotional instability, irritability, and increased aggression. The apparent contradiction between restlessness and cage-grabbing and decreased activity in mice actually reflects a combined tendency of inhibitory and irritable liver stagnation. Furthermore, prolonged restlessness and stress can disrupt the flow of qi and blood, creating conditions conducive to blood stasis.

[0128] Slow weight gain is related to spleen deficiency and liver stagnation. The spleen governs digestion and transformation, and is the foundation of postnatal health. Spleen deficiency leads to impaired absorption of nutrients from food, resulting in malnutrition and stunted growth, or even weight loss. This is one of the most objective indicators of spleen deficiency. Furthermore, in Traditional Chinese Medicine's Five Elements theory, the liver belongs to Wood, and the spleen belongs to Earth. Wood controls Earth; long-term liver qi stagnation can negatively impact the spleen, further impairing its digestive function. Therefore, slow weight gain is a typical consequence of "liver disease affecting the spleen."

[0129] Changes in stool shape are related to spleen deficiency and phlegm-dampness. Loose stools (unformed, soft, and sticky) are a typical sign of spleen deficiency and dampness accumulation. When the spleen's function of transporting and transforming water and dampness declines, water accumulates and becomes dampness, which flows down to the large intestine, resulting in loose stools. If the stools are sticky, it is a characteristic of dampness or phlegm-dampness. In other words, loose or sticky stools directly indicate spleen deficiency and the generation of dampness / phlegm.

[0130] Dry, brittle body hair and hair loss are related to blood stasis and spleen deficiency. Traditional Chinese medicine believes that "without removing blood stasis, new blood cannot be generated." Long-term chronic stress or multiple causes can obstruct the flow of qi and blood, leading to stagnation in the meridians. As a result, the skin and hair lack nourishment, manifesting as dry, dull, lusterless, unruly, and even hair loss. In addition, insufficient spleen function and deficiency of qi and blood can also lead to dry and brittle hair.

[0131] A thick, greasy tongue coating is related to phlegm and dampness. A white, greasy, or thick, greasy white tongue coating is the gold standard for excessive internal dampness or phlegm.

[0132] Furthermore, a comparison of the apparent state evaluation results of experimental groups 1-3 with the blank group and model group in Table 2 shows that the medicinal and edible herbal compositions obtained in Examples 1-3 of this invention can effectively alleviate symptoms of liver stagnation, blood stasis, phlegm dampness, and spleen deficiency, that is, they have the effects of soothing the liver and regulating qi, resolving blood stasis and dissipating nodules, clearing heat and resolving phlegm, and strengthening the spleen and removing dampness. Meanwhile, a comparison of the apparent state evaluation results of experimental groups 1-3 with those of comparative experimental groups 1-2 in Table 2 shows that the medicinal and edible herbal compositions obtained in Examples 1-3 of this invention have more scientific compatibility and can achieve better effects of soothing the liver without harming yin, resolving blood stasis without harming the body's vital energy, removing dampness without causing dryness, and clearing heat without being cold.

[0133] 5. Behavioral assessment

[0134] Sleep experiment: Within 30 minutes after the last gavage administration, each group of mice was injected with sodium pentobarbital solution at a dose of 40 mg / kg, with an injection volume of 0.1 mL / 10 g. The sleep latency and total sleep duration were recorded, and the results are shown in Table 3.

[0135] Tail suspension test: The tails of mice in each group were suspended by a fixation strap with their noses 12 cm above the ground. After 1 minute of suspension, the time the mice remained still for the next 5 minutes was recorded. The results are shown in Table 3.

[0136] Elevated cross maze experiment: After placing each group of mice in a 40cm×60cm open field for 5 minutes, they were then placed in the center of an elevated cross maze. The number of times they entered the open arms of the cross maze and the time spent there were recorded within 5 minutes. The results are shown in Table 3. The open arms of the elevated cross maze were 30cm×5cm, the closed arms were 30cm×5cm×15cm, and the height was 50cm.

[0137] Table 3

[0138]

[0139] Note: Compared to the model group * P < 0.05 # P > 0.05; compared with experimental group 1, △ P < 0.05 ▴ P > 0.05.

[0140] Traditional Chinese medicine believes that when Yang enters Yin, the spirit finds peace; conversely, difficulty falling asleep and shallow sleep with frequent awakenings are often caused by phlegm-heat disturbing the heart or liver stagnation transforming into fire. Therefore, based on the comparison between the model group and experimental groups 1-3 in Table 3, it can be seen that experimental groups 1-3 have significantly shortened sleep latency and significantly prolonged total sleep time, demonstrating that the medicinal and edible herbal compositions obtained in Examples 1-3 of this invention have the effects of calming the mind, relieving irritability, clearing heat, and resolving phlegm. In addition, traditional Chinese medicine also believes that liver stagnation and qi stagnation can lead to depression and negative states, and anxiety is often caused by liver stagnation transforming into fire, phlegm-heat disturbing the interior, or qi stagnation and blood stasis. Therefore, based on the significantly shortened immobility time, increased number of times mice entered the open arm, and prolonged open arm residence time of the mice in experimental groups 1-3, it can be seen that the medicinal and edible herbal compositions obtained in Examples 1-3 of this invention have the effects of soothing the liver and regulating qi, clearing heat and resolving phlegm, and resolving blood stasis and dissipating nodules. In contrast, the number of times mice in experimental groups 1 and 2 entered the open arm and the extended time spent in the open arm did not show significant differences compared with the model group. Based on the comprehensive sleep test results and apparent state assessment, it can be concluded that the medicinal and edible herbal composition obtained in experimental groups 1 and 2 had poor efficacy in soothing the liver and regulating qi.

[0141] In summary, the mice in experimental groups 1-3 no longer exhibited depression (liver-soothing), anxiety (phlegm-heat clearing), and significantly improved sleep (soothing). Moreover, these improvements were not due to a single target but rather occurred synergistically. This demonstrates that the medicinal and edible herbal compositions obtained in Examples 1-3 of this invention holistically open up the entire pathological axis from qi stagnation to blood stasis and from spleen deficiency to phlegm-dampness, and have the effects of soothing the liver and regulating qi, resolving blood stasis and dissipating nodules, clearing heat and resolving phlegm, strengthening the spleen and removing dampness, and soothing the mind and relieving irritability.

[0142] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that after reading this application specification, they can still modify or make equivalent substitutions to the specific implementation of the present invention, but these modifications or changes do not depart from the protection scope of the pending claims of the present invention.

Claims

1. A medicinal and edible herbal composition with the effects of soothing the liver and regulating qi, resolving blood stasis and dissipating nodules, characterized in that, The raw materials for preparation, by weight, include: 6-10 parts dandelion, 5-9 parts Amaryllis leaves, 2-6 parts Buddha's hand, 1-3 parts hawthorn, 1-3 parts five-finger peach, 1-3 parts dried tangerine peel, 1-3 parts reed rhizome, 1-3 parts rose, and 0.5-2 parts osmanthus.

2. The medicinal and edible herbal composition according to claim 1, characterized in that, The dandelion is present in a greater proportion by weight than the Ampelopsis thunbergii leaves.

3. The method for preparing the medicinal and edible herbal composition according to any one of claims 1 to 2, characterized in that, The process includes the following steps: weighing the raw materials according to their weight proportions, drying them, pulverizing them, and obtaining the medicinal and edible herbal composition.

4. The preparation method according to claim 3, characterized in that, The pulverization process also includes sieving and / or sterilization.

5. The preparation method according to claim 4, characterized in that, The sieving process includes the step of passing the material through a 20-60 mesh sieve.

6. The preparation method according to claim 4, characterized in that, The sterilization process includes an ultraviolet sterilization step and / or a high-temperature instantaneous sterilization step.

7. A preparation having the effects of soothing the liver and regulating qi, resolving blood stasis and dissipating nodules, characterized in that, The composition of traditional Chinese medicine that is both food and medicine as described in any one of claims 1 to 2.

8. The formulation according to claim 7, characterized in that, The formulation also includes pharmaceutically acceptable excipients or food-acceptable excipients.

9. The formulation according to any one of claims 7 to 8, characterized in that, The dosage form of the preparation is tablets, powders, granules, or liquids.

10. The formulation according to any one of claims 7-8, characterized in that, The preparation is a medicine, health product, or food.

Images