A traditional Chinese medicine composition containing fresh dendrobium and a sugar-free granule thereof and application

Abstract

The application provides a traditional Chinese medicine composition containing fresh dendrobium, sugar-free granules and application thereof, and relates to the technical field of traditional Chinese medicines.The traditional Chinese medicine composition containing fresh dendrobium comprises the following raw medicinal materials and auxiliary materials in parts by weight: fresh dendrobium 100-1000 parts, radix puerariae 100-1000 parts, panax notoginseng 10-200 parts, diluent 100-1500 parts, and flavoring agent 1-50 parts; the diluent is at least one of dextrin, starch, mannitol, microcrystalline cellulose, soluble starch, maltose and lactose; and the flavoring agent is at least one of xylitol, aspartame, fructose, sucralose, citric acid, lactic acid, strawberry essence, banana essence and vanillin.The traditional Chinese medicine composition of the application replaces sucrose, which is used in large quantities in traditional granules, with specific diluents and flavoring agents, so that the dosage is reduced, the composition is suitable for obese people and diabetic patients, and the suitable population is expanded.The preparation method has the advantages of easy granulation, appropriate granule hardness, low hygroscopicity and the like, and the composition has the effects of dispelling alcohol and protecting liver.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition containing fresh Dendrobium, sugar-free granules, and their applications. Background Technology

[0002] Compound Fresh Dendrobium Granules are a traditional Chinese medicine. Its main ingredients include fresh Dendrobium, kudzu root, and Panax notoginseng. Clinically, it nourishes Yin and the stomach, clears heat and quenches thirst, and promotes the production of body fluids. It is used for symptoms such as dry mouth and throat, loss of appetite, red tongue with little saliva, dryness and heat after drinking alcohol, and thirst due to insufficient stomach Yin. It has unique efficacy for Yin deficiency and fluid depletion caused by poor lifestyle habits, chronic illness, seasonal factors, etc. It is suitable for a wide range of people, including those with dry mouth, thirst, dry throat, chronic pharyngitis, constipation, hemorrhoids, those who work overtime, middle-aged and elderly people, menopausal women, people with cardiovascular and cerebrovascular diseases, smokers, and drinkers. Furthermore, it has good therapeutic effects on patients who are drunk, and on those whose stomach Yin deficiency is caused by excessive consumption of raw or cold foods, spicy foods, or emotional distress leading to Qi stagnation and heat.

[0003] Compound Dendrobium officinale granules are a pure Chinese medicine formula for treating stomach diseases. However, the traditional wet granulation process of these granules has disadvantages such as high viscosity of the extract, difficulty in granulation, and high sucrose content. In addition, sucrose has strong biological activity, which can cause gastritis, obesity, and diabetes, making the granules unsuitable for patients with diabetes and other sugar-restricted diseases.

[0004] Therefore, the development of sugar-free compound Dendrobium officinale granules is of great significance. Summary of the Invention

[0005] In view of this, the present invention proposes a traditional Chinese medicine composition containing fresh Dendrobium, sugar-free granules, and applications.

[0006] The technical solution of this invention is implemented as follows: A traditional Chinese medicine composition containing fresh Dendrobium, comprising the following raw materials and excipients in parts by weight: 100-1000 parts fresh Dendrobium, 100-1000 parts Pueraria lobata, 10-200 parts Panax notoginseng, 100-1500 parts diluent, and 1-50 parts flavoring agent. This invention replaces a large amount of sucrose in compound Dendrobium granules with specific diluents and flavoring agents, avoiding the shortcomings of sugar-containing granules such as hygroscopicity, softening and deterioration, and short shelf life, thereby improving drug stability and ensuring clinical efficacy. Because the amount of sucrose and other excipients used is reduced, the weight of a single-dose package is greatly reduced, making the drug more convenient to take and carry. The granules prepared by this invention have good flowability and solubility, uniform properties, and stable drug quality.

[0007] Furthermore, the composition comprises the following raw materials and excipients in parts by weight: 200-800 parts of fresh Dendrobium, 200-800 parts of Pueraria lobata, 10-150 parts of Panax notoginseng, 300-900 parts of diluent, and 5-20 parts of flavoring agent.

[0008] Furthermore, the composition comprises the following raw materials and excipients in parts by weight: 350-500 parts of fresh Dendrobium, 500 parts of Pueraria lobata, 50-65 parts of Panax notoginseng, 600-750 parts of diluent, and 7.5-10 parts of flavoring agent.

[0009] Furthermore, the composition comprises the following parts by weight of active pharmaceutical ingredients and excipients: 375 parts of fresh Dendrobium, 500 parts of Pueraria lobata, 62.5 parts of Panax notoginseng, 860 parts of diluent, and 7.5 parts of flavoring agent; or 225 parts of fresh Dendrobium, 300 parts of Pueraria lobata, 37.5 parts of Panax notoginseng, 540 parts of diluent, and 4.5 parts of flavoring agent.

[0010] Furthermore, the diluent is at least one selected from dextrin, starch, mannitol, microcrystalline cellulose, soluble starch, maltose, and lactose.

[0011] Furthermore, the flavoring agent is at least one selected from xylitol, aspartame, fructose, sucralose, citric acid, lactic acid, strawberry flavor, banana flavor, and vanillin.

[0012] Furthermore, the diluent is composed of mannitol and dextrin, wherein the mass ratio of mannitol to dextrin is 1:0.5-1, preferably 1:0.8.

[0013] Furthermore, the flavoring agent is composed of sucralose and citric acid, wherein the mass ratio of sucralose to citric acid is 1:1.9-2.1.

[0014] A sugar-free granule containing fresh Dendrobium is prepared from the traditional Chinese medicine composition described in any one of the present invention.

[0015] This invention also provides a method for preparing sugar-free granules containing fresh Dendrobium, comprising the following steps: (1) Take fresh Dendrobium, cut it into sections, add 5-15 times the amount of water, decoct twice, each time for 0.5-2.5 hours, combine the decoctions, filter, concentrate the filtrate to an appropriate amount, add ethanol to make the alcohol content 60%-70%, let stand, and take the supernatant for later use. (2) Take kudzu root and Panax notoginseng, crush them separately, add 5-15 times the amount of water, decoct three times, each time for 1-3 hours, combine the decoctions, filter, concentrate the filtrate to an appropriate amount, add ethanol to make the alcohol content 60%-70%, let stand, and take the supernatant for later use. (3) Combine the supernatants from steps (1) and (2), recover the ethanol and concentrate it to a thick paste with a relative density of 1.1-1.4 at 60℃; (4) Add the above thick paste to the diluent, flavoring agent and wetting agent and mix evenly; sieve the mixture to granulate, and dry it at 40℃-80℃ until the moisture content is 3%-5% to obtain sugar-free granules.

[0016] Furthermore, in step (4), the wetting agent is a 70%-95% v / v ethanol solution, and the amount of the wetting agent added is 18%-22% of the weight of the paste.

[0017] The traditional Chinese medicine composition or sugar-free granules described in any one of the present invention may be used in the preparation of hangover remedies and / or liver-protecting drugs.

[0018] Furthermore, the dosage of the granules is 250-500 μg / mL.

[0019] Compared with the prior art, the beneficial effects of the present invention are: This invention provides a traditional Chinese medicine composition granule containing fresh Dendrobium, which uses specific diluents and flavoring agents to replace the large amounts of sucrose used in traditional granules. This not only reduces the dosage but also makes it suitable for obese individuals and diabetic patients, thus expanding the suitable population. The preparation method has advantages such as easy granulation, suitable granule hardness, and low hygroscopicity.

[0020] Furthermore, in-depth research and extensive experimental data of this invention demonstrate that the prepared compound fresh Dendrobium granules (250-500 μg / mL) not only exhibit significant hangover-relieving effects but also provide effective adjuvant protection against alcoholic fatty liver disease. These granules help improve liver function and reduce alcohol-induced liver damage, thus achieving the dual benefits of hangover relief and liver protection. This discovery further broadens the application scope of this drug, giving it promising application prospects and clinical value in the area of ​​hangover relief and liver protection.

[0021] (1) The traditional Chinese medicine for relieving hangovers and protecting the liver provided by the present invention is a sugar-free granule dosage form, which is not easy to absorb moisture, has good stability, and requires less dosage for better efficacy, thus expanding the range of suitable users.

[0022] (2) The sugar-free granule preparation method provided by the present invention has high granulation efficiency, low amount of excipients, and can reduce problems such as granule discoloration and component loss.

[0023] (3) Further research of the present invention found that mannitol and dextrin are preferred as diluents, which not only improve the viscosity and flowability of the extract of traditional Chinese medicine, but also make the granules palatable; at the same time, mannitol is also beneficial to improve the taste of traditional Chinese medicine preparations. Attached Figure Description

[0024] Figure 1 This represents the percentage of moisture absorbed by the dry particles.

[0025] Figure 2This is the critical relative humidity for dry particles.

[0026] Figure 3 Typical zebrafish movement trajectories after sample treatment. In the figure, the black line represents the distance of slow movement, the green line represents the distance of medium movement, and the red line represents the distance of fast movement.

[0027] Figure 4 The total distance traveled by zebrafish after sample treatment was compared with that of the model control group. *p<0.05, **p<0.01, ***p<0.001.

[0028] Figure 5 Typical image of zebrafish liver fat staining intensity after sample processing. In the image, the yellow dashed box represents the analysis area.

[0029] Figure 6 The intensity of liver fat staining in zebrafish after sample treatment was significantly different from that in the model control group. *p<0.05, ***p<0.001. Detailed Implementation

[0030] Unless otherwise specified, the experimental methods used in the embodiments of this invention are conventional methods; Unless otherwise specified, all materials and reagents used in the embodiments of this invention are commercially available.

[0031] Example 1 This embodiment provides a traditional Chinese medicine composition containing fresh Dendrobium, which includes the following raw materials and excipients in parts by weight: 100-1000 parts fresh Dendrobium, 100-1000 parts kudzu root, 10-200 parts Panax notoginseng, 100-1500 parts diluent, 1-50 parts flavoring agent, and appropriate amount of wetting agent.

[0032] The diluent is one or a combination of two or more of the following: starch, dextrin, mannitol, microcrystalline cellulose, soluble starch, and lactose.

[0033] The flavoring agent is at least one of xylitol, aspartame, fructose, sucralose, citric acid, lactic acid, strawberry flavor, banana flavor, and vanillin.

[0034] The wetting agent is a 70%-95% v / v ethanol solution.

[0035] Example 2 This embodiment provides a traditional Chinese medicine composition containing fresh Dendrobium, which includes the following raw materials and excipients in parts by weight: Fresh Dendrobium 200-800 parts, Kudzu Root 200-800 parts, Panax Notoginseng 10-150 parts, Diluent 300-900 parts, Flavoring Agent 5-20 parts, Humidifier as needed.

[0036] The diluent is one or a combination of two or more of the following: starch, dextrin, mannitol, microcrystalline cellulose, soluble starch, and lactose.

[0037] The flavoring agent is at least one of xylitol, aspartame, fructose, sucralose, citric acid, lactic acid, strawberry flavor, banana flavor, and vanillin.

[0038] The wetting agent is an 80%-95% v / v ethanol solution.

[0039] Example 3 This embodiment provides a traditional Chinese medicine composition containing fresh Dendrobium, which includes the following raw materials and excipients in parts by weight: 350 parts fresh Dendrobium, 500 parts kudzu root, 65 parts Panax notoginseng, 750 parts diluent, 7.5 parts flavoring agent, and appropriate amount of wetting agent.

[0040] The diluent is one or a combination of two or more of the following: starch, dextrin, mannitol, microcrystalline cellulose, soluble starch, and lactose.

[0041] The flavoring agent is at least one of xylitol, aspartame, fructose, sucralose, citric acid, lactic acid, strawberry flavor, banana flavor, and vanillin; The wetting agent is an 85%-95% v / v ethanol solution.

[0042] Example 4 This embodiment provides a traditional Chinese medicine composition containing fresh Dendrobium, which includes the following raw materials and excipients in parts by weight: 500 parts fresh Dendrobium, 500 parts kudzu root, 50 parts Panax notoginseng, 600 parts diluent, 10 parts flavoring agent, and appropriate amount of wetting agent.

[0043] The diluent is one or a combination of two or more of the following: starch, dextrin, mannitol, microcrystalline cellulose, soluble starch, and lactose.

[0044] The flavoring agent is at least one of xylitol, aspartame, fructose, sucralose, citric acid, lactic acid, strawberry flavor, banana flavor, and vanillin.

[0045] The wetting agent is an 85%-95% v / v ethanol solution.

[0046] Example 5 This embodiment provides a method for preparing a traditional Chinese medicine composition containing fresh Dendrobium, which includes the following steps: (1) Weigh fresh Dendrobium according to the predetermined weight ratio, cut it into sections, add 5-15 times the amount of water, decoct twice, each time for 0.5-2.5 hours, combine the decoctions, filter, concentrate the filtrate to an appropriate amount, add ethanol to make the alcohol content 60%-70%, let stand, and take the supernatant for later use. (2) Weigh kudzu root and Panax notoginseng according to the predetermined weight ratio, crush them separately, add 5-15 times the amount of water, decoct three times, each time for 1-3 hours, combine the decoctions, filter, concentrate the filtrate to an appropriate amount, add ethanol to make the alcohol content 60%-70%, let stand, and take the supernatant for later use. (3) Combine the supernatants of (1) and (2), recover the ethanol and concentrate to a thick paste with a relative density of 1.1-1.4 (60℃).

[0047] (4) After determining the dry paste rate of the thick paste, add a diluent, flavoring agent and wetting agent in a predetermined weight ratio. The amount of wetting agent added is 18%-22% of the weight of the thick paste. Mix evenly. Sieve the mixture to granulate, dry it at 40℃-80℃ to dry granules with a moisture content of 3%-5%, and sieve it through a 10-mesh sieve and a 40-mesh granulator to obtain the sugar-free Chinese medicine granules. During the granulation, packaging, and storage of this traditional Chinese medicine composition, the CRH (critical relative humidity) of the environment should be controlled at 70%-74.19%.

[0048] In this embodiment, the "predetermined weight ratio" can be the weight component of the traditional Chinese medicine composition described in any of the embodiments 1 to 4.

[0049] Example 6 This embodiment provides a traditional Chinese medicine composition containing fresh Dendrobium and its preparation method. The traditional Chinese medicine composition includes the following weight parts of raw materials and excipients: The ingredients included 375 parts fresh dendrobium, 500 parts kudzu root, 62.5 parts Panax notoginseng, 900 parts diluent, and 7.5 parts flavoring agent. The flavoring agent consisted of 2.5 parts sucralose and 5 parts citric acid. The diluent consisted of 500 parts mannitol and 400 parts dextrin.

[0050] Preparation method: (1) Cut fresh dendrobium into sections, add 8 times the amount of water, decoct twice, 1.5 hours each time, combine the decoctions, filter, concentrate the filtrate to an appropriate amount, add ethanol to make the alcohol content 65%, let stand, and take the supernatant for later use. (2) After crushing the kudzu root and Panax notoginseng separately, add 10 times the amount of water and decoct three times, each time for 2 hours. Combine the decoctions, filter, concentrate the filtrate to an appropriate amount, add ethanol to make the alcohol content 65%, let stand, and take the supernatant for later use. (3) Combine the supernatants from steps (1) and (2), recover the ethanol and concentrate to a thick paste with a relative density of 1.25-1.30 (60℃). (4) Add mannitol, dextrin, sucralose and citric acid to the above thick paste, and use 95% v / v ethanol solution as a wetting agent. The amount of 95% v / v ethanol solution added is 20% of the weight of the thick paste. Mix evenly. Sieve the mixture to granulate, dry it at 60°C to dry granules with a moisture content of 4%, and then pass it through a 10-mesh sieve and a 40-mesh granulator to obtain the final product.

[0051] Example 7 This embodiment provides a traditional Chinese medicine composition containing fresh Dendrobium and its preparation method. The traditional Chinese medicine composition includes the following weight parts of raw materials and excipients: The ingredients were: 225 parts fresh dendrobium, 300 parts kudzu root, 37.5 parts Panax notoginseng, 540 parts diluent, and 4.5 parts flavoring agent. The flavoring agent consisted of 1.5 parts sucralose and 3 parts citric acid. The diluent consisted of 300 parts mannitol and 240 parts dextrin.

[0052] Preparation method: (1) Cut fresh dendrobium into sections, add 8 times the amount of water, decoct twice, 1.5 hours each time, combine the decoctions, filter, concentrate the filtrate to an appropriate amount, add ethanol to make the alcohol content 65%, let stand, and take the supernatant for later use. (2) After crushing the kudzu root and Panax notoginseng separately, add 10 times the amount of water and decoct three times, each time for 2 hours. Combine the decoctions, filter, concentrate the filtrate to an appropriate amount, add ethanol to make the alcohol content 65%, let stand, and take the supernatant for later use. (3) Combine the supernatants from steps (1) and (2), recover the ethanol and concentrate to a thick paste with a relative density of 1.25-1.30 (60℃). (4) Add mannitol, dextrin, sucralose and citric acid to the above thick paste, and use 95% v / v ethanol solution as a wetting agent. The amount of 95% v / v ethanol solution added is 20% of the weight of the thick paste. Mix evenly. Sieve the mixture to granulate, dry it at 60°C to dry granules with a moisture content of 4%, and then pass it through a 10-mesh sieve and a 40-mesh granulator to obtain the final product.

[0053] Research embodiments of the present invention: This invention develops a traditional Chinese medicine composition containing fresh Dendrobium and its preparation method. The selection and proportion of excipients have a significant impact on the quality and efficacy of the medicine. In order to explore the optimal extraction process, the optimal ratio of raw materials to excipients, and the molding process, the inventors conducted a large number of experiments.

[0054] The required dosage for each administration of this formula is equivalent to 1.875g of the prepared herbal medicine. After extraction, concentration, and impurity removal, the dry extract yield is approximately 10%, and the required dosage for each administration is equivalent to approximately 0.19g of dry extract powder. Since the granules are packaged in 2g packets, 1.8g of excipients can be added to improve the flowability and hygroscopicity of the dry extract powder. Therefore, the preliminary drug-excipient ratio for this experiment is 1:0.9.

[0055] In the preliminary experiments, it was found that the thick paste had a high sugar content and strong viscosity. Ordinary drying methods were time-consuming and difficult to thoroughly dry, making it impossible to pulverize into fine powder. If the thick paste and excipients were directly granulated, drying time and energy could be saved, but it would easily cause uneven particle color. Therefore, 70%, 80%, 90%, and 95% ethanol by volume percentage could be selected as dispersants. When the ethanol concentration was low, the soft material was prone to clumping due to the high sugar content and strong viscosity of the thick paste. As the ethanol concentration increased, the clumping of the soft material gradually decreased. When the ethanol concentration was 95% v / v, the soft material easily reached the state of "being able to be squeezed into a ball by hand and then dispersed when pressed", with less clumping. Therefore, this experiment initially proposed 95% v / v ethanol as the dispersant for the thick paste.

[0056] When 95% v / v ethanol is selected as the wetting agent, and the dry paste powder and excipients are mixed in a ratio of 1 (amount of thick paste = amount of dry paste powder / dry paste rate) : 9, it is found that when the amount of ethanol added accounts for 20% of the amount of thick paste, the soft material can reach the state of "being kneaded into a ball by hand and easily dispersed when pressed". During granulation, the soft material is easy to pass through the sieve and the granules have a uniform color.

[0057] 1. Research on excipients Weigh the thick paste (dry paste rate 63.2%) prepared in Example 7, select dextrin, mannitol, D-lactose and soluble starch as excipients, and mix the dry paste powder and excipients in a weight ratio of 1:9, wherein the amount of dry paste powder = the amount of thick paste × dry paste rate. Add a wetting agent (95% v / v ethanol) at a ratio of 20% of the weight of the thick paste, and prepare granules. The granulation condition, granule characteristics and solubility are used as indicators for comprehensive evaluation as preliminary excipients for further research. The results are shown in Table 1 below.

[0058] Table 1 Results of studies on single excipients

[0059] Therefore, dextrin shows a relatively significant improvement in molding rate and flowability, while mannitol performs better in terms of solubility and is superior to other excipients in improving the hygroscopicity of particles. Furthermore, mannitol itself can be used as a diluent and a flavoring agent to improve the taste of traditional Chinese medicine preparations. Due to lactose intolerance and the inability of diabetic patients to consume starch, and considering expanding the suitable population, dextrin and mannitol were selected as initial excipients for further research.

[0060] 2. Research on the proportion of excipients Based on Example 7, the proportions of the diluent components were adjusted. The traditional Chinese medicine composition includes the following weight parts of raw materials and excipients: 225 parts of fresh Dendrobium, 300 parts of Pueraria lobata, 37.5 parts of Panax notoginseng, 540 parts of diluent, and 4.5 parts of flavoring agent, wherein the flavoring agent is 1.5 parts of sucralose and 3 parts of citric acid.

[0061] Treatment 1: 540 parts of diluent, which consists of 180 parts mannitol and 360 parts dextrin, i.e., mannitol:dextrin mass ratio = 1:2; Treatment 2: 540 parts of diluent, which consists of 270 parts mannitol and 270 parts dextrin, i.e., mannitol:dextrin mass ratio = 1:1; Treatment 3: 540 parts of diluent, which consists of 300 parts mannitol and 240 parts dextrin, i.e., mannitol:dextrin mass ratio = 1:0.8; Treatment 4: 540 parts of diluent, which consisted of 360 parts mannitol and 180 parts dextrin, i.e., the mass ratio of mannitol to dextrin was 1:0.5.

[0062] Granules were prepared according to treatments 1-4, and a comprehensive evaluation was conducted based on granulation conditions, granule properties, and solubility. The results are shown in Table 2 below.

[0063] Comprehensive index = (21 / maximum moldability value) × molding rate value + (22 / maximum melting rate) × melting rate value + (35 × minimum moisture absorption rate) / moisture absorption rate value + (22 × minimum angle of repose) / angle of repose value Table 2 Results of the study on mixed excipients

[0064] The results showed that the hygroscopicity of the mixed excipients was mostly controlled below 10%, the solubility and molding rate were both above 90%, and the angle of repose was below 30°. The comprehensive score showed that the granules made from the mannitol:dextrin (1:0.5-1) mixed excipients had a better overall score.

[0065] 3. Research on flavoring agents The bitterness in this traditional Chinese medicine composition mainly comes from puerarin in kudzu root, and the aqueous solution of puerarin has a high bitterness; secondly, the saponins of Panax notoginseng also have some bitterness.

[0066] Based on Example 7, the proportions of the flavoring agent components were adjusted. The traditional Chinese medicine composition includes the following parts by weight of raw materials and excipients: 225 parts of fresh Dendrobium, 300 parts of Pueraria lobata, 37.5 parts of Panax notoginseng, 540 parts of diluent, and 4.5 parts of flavoring agent. The diluent consists of 300 parts of mannitol and 240 parts of dextrin.

[0067] Treatment 1: 4.5 parts flavoring agent, which consists of 0.6 parts sucralose and 3.9 parts citric acid; Treatment 2: 4.5 parts flavoring agent, which consists of 0.9 parts sucralose and 3.6 parts citric acid; Treatment 3: 4.5 parts flavoring agent, which consists of 1.2 parts sucralose and 3.3 parts citric acid; Treatment 4: 4.5 parts flavoring agent, which consists of 1.5 parts sucralose and 3.0 parts citric acid; Treatment 5: 4.5 parts flavoring agent, which consists of 1.8 parts sucralose and 2.7 parts citric acid.

[0068] The granules were prepared according to the above process. 2g of granules were dissolved in 100ml of hot water and then tasted by 10 volunteers to determine the taste. The experimental results are shown in Table 3 below.

[0069] Table 3 Results of the study on the proportion of flavoring agents

[0070] The results showed that the granules prepared by treatment 4 were slightly sweet, easy to accept, and had the best taste. The optimal choice was when the mass ratio of sucralose to citric acid in the flavoring agent was 1:2.

[0071] 4. Determination of the moisture absorption percentage of dry particles and critical relative humidity (1) Determination of the moisture absorption percentage of dry granules Experimental Method: The dry granules obtained in Example 7 were weighed and dried for 48 hours to constant weight within the phosphorus pentoxide drying period. A desiccator containing a supersaturated sodium chloride solution at the bottom was placed in a 25°C constant temperature incubator for 24 hours, at which time the relative humidity inside the desiccator was 75%. The sample (approximately 2 mm thick) was placed at the bottom of a weighing bottle that had reached constant weight. After accurate weighing, the sample was placed in the glass desiccator containing the supersaturated sodium chloride solution (with the weighing bottle cap open) and stored in a 25°C constant temperature incubator. Weighing was performed periodically (2, 6, 12, 24, 36, 48, 60, 72 hours), and the moisture absorption rate was calculated. The results are shown in Table 4, and a moisture absorption percentage graph was plotted. Figure 1 .

[0072] Table 4. Moisture Absorption Percentage of Dry Granules (%)

[0073] (2) Determination of critical relative humidity for dry particles Experimental Method: Seven different sulfuric acid or supersaturated salt solutions were prepared according to the table. Each solution was placed in a separate glass desiccator. After the weighing bottles reached constant weight, approximately 2 mm of dry granules prepared as in Example 4 were added. After weighing, the solutions were placed in glass desiccators of different concentrations (with the weighing bottle caps open). The desiccators were then placed in a 25°C constant temperature incubator for 7 days. The moisture absorption percentage was calculated, and the results are shown in Table 5. A moisture absorption percentage graph was plotted with relative humidity (RH%) on the x-axis and moisture absorption percentage (%) on the y-axis (see Table 5). Figure 2 The moisture absorption percentage is calculated using the following formula.

[0074] Moisture absorption percentage (%) = (Weight of sample after moisture absorption - Weight of sample before moisture absorption) / Weight of sample before moisture absorption Table 5. Moisture absorption percentage of dry particles under different relative humidity conditions

[0075] Results Analysis (Calculation Method): Based on the characteristics of the moisture absorption curve, two straight line equations are established using the first two points and the last two points of the curve, respectively. The critical relative humidity is the x-coordinate corresponding to the intersection of the two straight lines. The result can be obtained through calculation.

[0076] Substituting the percentage of moisture absorption at the first two points into y1 = a1 + b1x, we get 0.95 = 29.55b1 + a1; 1.93 = 40.52b1 + a1. Calculations show a1 = -1.68 and b1 = 0.089, so the equation of the line is y1 = 0.089x - 1.68. Substituting the percentage of moisture absorption at the last two points into y2 = a2 + b2x, we get 37.84 = 92.48b2 + a2; 23.04 = 84.26b2 + a2. Calculations show a2 = -128.624 and b2 = 1.80, so the equation of the line is y2 = 1.80x - 128.624. The critical humidity (CRH) is the x-coordinate of the intersection of the two lines, which is x = 74.19.

[0077] Therefore, the CRH of the environment during the granulation, packaging, and storage of dry pellets should be controlled below 74.19% to prevent the dry pellets from absorbing moisture and affecting the quality of the finished product.

[0078] Example 8 1. Testing materials 1.1. Sample Preparation Information Test sample: Compound fresh Dendrobium granules (Example 6), solvent was ultrapure water.

[0079] Positive control: L-reduced glutathione (hereinafter referred to as glutathione), white powder, batch number SLCG8572, Sigma, solvent is ultrapure water.

[0080] 2. Experimental Methods 2.1 Evaluation of its hangover-relieving effects Wild-type AB strain zebrafish (5 dpf) were randomly selected and placed in 6-well plates, with 30 zebrafish treated in each well (experimental group). Samples were administered in water (concentrations shown in Tables 1-2), with a positive control of 400 μg / mL glutathione. A normal control and a model control group were also included, with a volume of 3 mL per well. After treatment at 28℃ for one day, 10 zebrafish from each experimental group were randomly transferred to 96-well plates. Except for the normal control group, all other experimental groups were given anhydrous ethanol in water to establish a zebrafish intoxication model. The zebrafish were immediately placed in a behavioral analyzer, and the total movement distance within 1 hour was measured. The statistical analysis results of this indicator were used to evaluate the sobering effect of the samples. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software; p < 0.05 indicated statistical significance.

[0081] 2.2. Evaluation of the adjunctive protective efficacy against alcoholic fatty liver disease (phenotype) Wild-type AB strain zebrafish (5 dpf) were randomly selected and placed in 6-well plates, with 30 zebrafish treated in each well (experimental group). Samples (concentrations shown in Tables 1-3) were administered in water, with a positive control of 400 μg / mL glutathione. A normal control and a model control group were also included, with a volume of 3 mL per well. Except for the normal control group, all other experimental groups were treated with anhydrous ethanol to establish a zebrafish alcoholic fatty liver model. After treatment at 28℃ for 30 h, samples were collected, stained with Oil Red O, and bleached. Ten zebrafish from each experimental group were randomly selected and photographed under a dissecting microscope. Data were collected using NIS-Elements D 3.20 advanced image processing software, and the intensity of liver fat staining was analyzed. The statistical analysis results of this index were used to evaluate the auxiliary protective efficacy of the samples against alcoholic fatty liver. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software; p < 0.05 indicated statistical significance.

[0082] 3.1 Evaluation of its hangover-relieving effects Under the conditions of this experiment, the compound fresh Dendrobium granules have a hangover-relieving effect. See Table 6 for details. Figure 3 , Figure 4 .

[0083] Table 6. Experimental results evaluating the hangover relief efficacy of the samples (n = 10)

[0084] Note: Compared with the model control group, *p<0.05, **p<0.01, ***p<0.001 3.2. Evaluation of the adjunctive protective efficacy against alcoholic fatty liver disease (phenotype) Under the conditions of this experiment, compound fresh Dendrobium granules showed an auxiliary protective effect against alcoholic fatty liver. See Table 7 for details. Figure 5 , Figure 6 .

[0085] Table 7. Evaluation results of the adjuvant protective efficacy of the samples against alcoholic fatty liver disease (phenotype) (n = 10)

[0086] Note: Compared with the model control group, *p<0.05, ***p<0.001.

[0087] In summary, the compound fresh Dendrobium granules (250-500 μg / mL) prepared by this invention not only have a good hangover-relieving effect, but also have an auxiliary protective effect on alcoholic fatty liver, and can be effectively used in the preparation of hangover-relieving and liver-protecting products.

[0088] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the scope of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition containing fresh Dendrobium, characterized in that, The composition comprises the following raw materials and excipients in parts by weight: 100-1000 parts of fresh Dendrobium, 100-1000 parts of Pueraria lobata, 10-200 parts of Panax notoginseng, 100-1500 parts of diluent, and 1-50 parts of flavoring agent; wherein the diluent is at least one of dextrin, starch, mannitol, microcrystalline cellulose, soluble starch, maltose, and lactose; and wherein the flavoring agent is at least one of xylitol, aspartame, fructose, sucralose, citric acid, lactic acid, strawberry flavor, banana flavor, and vanillin.

2. The traditional Chinese medicine composition containing fresh Dendrobium according to claim 1, characterized in that, The composition comprises the following raw materials and excipients in parts by weight: 200-800 parts of fresh Dendrobium, 200-800 parts of Pueraria lobata, 10-150 parts of Panax notoginseng, 300-900 parts of diluent, and 5-20 parts of flavoring agent.

3. The traditional Chinese medicine composition containing fresh Dendrobium according to claim 2, characterized in that, The composition comprises the following raw materials and excipients in parts by weight: 375 parts fresh Dendrobium, 500 parts kudzu root, 62.5 parts Panax notoginseng, 900 parts diluent, and 7.5 parts flavoring agent; or 225 parts fresh Dendrobium, 300 parts kudzu root, 37.5 parts Panax notoginseng, 540 parts diluent, and 4.5 parts flavoring agent.

4. The traditional Chinese medicine composition containing fresh Dendrobium according to claim 1, characterized in that, The diluent consists of mannitol and dextrin, and the flavoring agent consists of sucralose and citric acid.

5. The traditional Chinese medicine composition containing fresh Dendrobium according to claim 4, characterized in that, The mass ratio of mannitol to dextrin in the diluent is 1:0.5-1; the mass ratio of sucralose to citric acid in the flavoring agent is 1:1.9-2.

1.

6. A sugar-free granule containing fresh Dendrobium, characterized in that, It is prepared from the traditional Chinese medicine composition according to any one of claims 1-5.

7. The sugar-free granules containing fresh Dendrobium according to claim 6, characterized in that, The method for preparing the sugar-free granules includes the following steps: (1) Take fresh Dendrobium, cut it into sections, add 5-15 times the amount of water, decoct twice, each time for 0.5-2.5 hours, combine the decoctions, filter, concentrate the filtrate to an appropriate amount, add ethanol to make the alcohol content 60%-70%, let stand, and take the supernatant for later use. (2) Take kudzu root and Panax notoginseng, crush them separately, add 5-15 times the amount of water, decoct three times, each time for 1-3 hours, combine the decoctions, filter, concentrate the filtrate to an appropriate amount, add ethanol to make the alcohol content 60%-70%, let stand, and take the supernatant for later use. (3) Combine the supernatants from steps (1) and (2), recover the ethanol and concentrate it to a thick paste with a relative density of 1.1-1.4 at 60℃; (4) Add the above thick paste to the diluent, flavoring agent and wetting agent and mix evenly; sieve the mixture to granulate, and dry it at 40℃-80℃ until the moisture content is 3%-5% to obtain sugar-free granules.

8. The sugar-free granules containing fresh Dendrobium according to claim 7, characterized in that, In step (4), the wetting agent is a 70%-95% v / v ethanol solution, and the amount of the wetting agent added is 18%-22% of the weight of the paste; During the granulation, packaging, and storage of the sugar-free granules, the environmental CRH is controlled at 70%-74.19%.

9. The traditional Chinese medicine composition according to any one of claims 1-6 or the sugar-free granules according to any one of claims 7-8 are used in the preparation of hangover remedies and / or liver-protecting drugs.

10. The application according to claim 9, characterized in that, The dosage of the granules is 250-500 μg / mL.

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