Preparation method of dried orange peel and dark plum effervescent tablet and application of dried orange peel and dark plum effervescent tablet in promoting digestion and relieving cough

Abstract

The invention provides a preparation method of dried orange peel and dark plum effervescent tablets and application of the dried orange peel and dark plum effervescent tablets in promoting digestion and relieving cough, and belongs to the technical field of pharmaceutical preparations. The preparation method of the dried orange peel and dark plum effervescent tablet comprises the following steps: extracting dried orange peel and dark plum to obtain an extracting solution; concentrating and drying the extracting solution to obtain dried orange peel and dark plum extract powder; equally dividing the dried orange peel and dark plum extract powder into two parts, respectively adding citric acid and sodium bicarbonate, spraying a 9.5% povidone-ethanol solution, and drying to obtain acid granules and alkali granules; and mixing the acid granules, the alkali granules, lactose, PEG 6000 and mogroside, tabletting and drying to obtain the dried orange peel and dark plum effervescent tablets. The dried orange peel and dark plum effervescent tablet prepared by the invention is short in disintegration time limit and good in taste, can effectively avoid the sticking problem, has the effects of relieving or treating functional dyspepsia and cough, and can be used for preparing related health care products and medicines.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical preparation technology, specifically relating to a method for preparing tangerine peel and dried plum effervescent tablets and their application in promoting digestion and relieving cough. Background Technology

[0002] Digestive system dysfunction and respiratory discomfort (such as cough) are common clinical health problems, widely present in people of all ages. The fast pace of modern life, unbalanced diets, and environmental stimuli have led to a continuous increase in the incidence of symptoms such as indigestion, loss of appetite, dry throat, and cough, significantly impacting people's daily work and quality of life. Therefore, developing natural-sourced conditioning products that are both safe and effective has become an important direction for meeting market demand.

[0003] Both dried tangerine peel and dried plum are traditional ingredients used in traditional medicine and food. Currently, their application is mainly in traditional decoctions, infusions, or boiled beverages. While these methods can exert certain effects, they have significant limitations: First, the release of active ingredients is insufficient and uneven, resulting in low bioavailability and affecting the therapeutic effect; second, the products have poor stability, are easily affected by storage conditions and deteriorate, and have a short shelf life; third, they are not convenient to take, requiring on-site brewing or decoction; and fourth, the taste is difficult to control, and it is not easy to accurately control the dosage per dose. Although some studies have attempted to formulate them into granules or tablets, problems such as slow dissolution and absorption and poor palatability have not yet been solved.

[0004] Effervescent tablets, as a novel type of solid oral dosage form, are widely used in the pharmaceutical and health care fields due to their unique advantages. This dosage form, through the addition of effervescent disintegrants, rapidly disintegrates in water, releasing a large number of bubbles, significantly accelerating the dissolution and dispersion of active ingredients, thereby improving bioavailability. They do not require swallowing, making them especially suitable for children, the elderly, and those with poor swallowing function. Furthermore, the taste can be improved through the appropriate selection of flavoring agents and other excipients, and the tablet form facilitates quantitative dosage and long-term storage, meeting the modern consumer demand for convenient and efficient products.

[0005] However, there are no existing reports on the effective combination of dried tangerine peel and dried plum in the preparation of effervescent tablets. Because the volatile oil components in dried tangerine peel are easily lost through volatilization, and dried plum has a high content of organic acids, both may interact with the effervescent agent during the preparation of effervescent tablets, affecting the tablet's disintegration performance, stability, and palatability. Furthermore, since both dried tangerine peel and dried plum contain a large amount of sugar and have high viscosity, they are prone to sticking and tumbling during tableting, resulting in poor tablet quality. Therefore, there is an urgent need to develop a method for preparing dried tangerine peel and dried plum effervescent tablets that can effectively retain the active ingredients of dried tangerine peel and dried plum, while also considering disintegration efficiency, stability, and palatability, to improve the utilization prospects of dried tangerine peel and dried plum. Summary of the Invention

[0006] In order to solve the problems existing in the prior art, the first objective of the present invention is to provide a method for preparing tangerine peel and dried plum effervescent tablets, the resulting effervescent tablets having better disintegration performance, stability and taste, and can effectively exert the pharmacological effects of tangerine peel and dried plum.

[0007] The second objective of this invention is to provide the application of tangerine peel and dried plum effervescent tablets in the preparation of related health products / medicines for relieving or treating functional dyspepsia / cough.

[0008] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a method for preparing tangerine peel and dried plum effervescent tablets, comprising the following steps: The tangerine peel and dried plum were extracted to obtain an extract; the extract was concentrated and dried to obtain tangerine peel and dried plum extract powder. The tangerine peel and dried plum extract powder was divided into two equal parts, designated as extract powder 1 and extract powder 2. Citric acid was added to extract powder 1, and it was sprayed with 9.5% povidone-ethanol solution and dried to obtain acid granules. Sodium bicarbonate was added to extract powder 2, and it was sprayed with 9.5% povidone-ethanol solution and dried to obtain alkali granules. The acid granules, alkali granules, lactose, PEG 6000 and mogroside were mixed, compressed into tablets, and dried to obtain tangerine peel and dried plum effervescent tablets.

[0009] Preferably, by weight, the tangerine peel and dried plum effervescent tablets comprise: 10-20 parts of tangerine peel and dried plum extract powder, 50-60 parts of disintegrant, 3 parts of lactose, 4-6 parts of PEG 6000, and 4 parts of mogroside; the disintegrant is citric acid and sodium bicarbonate, and the mass ratio of citric acid to sodium bicarbonate is (1.2-1.6):1.

[0010] Preferably, the mass ratio of dried tangerine peel to dried plum is 2:3.

[0011] Preferably, the extraction is performed 3 times, with each extraction lasting 1 hour, and the amount of water added each time is 1000 mL / 100g based on the total mass of tangerine peel and dried plum.

[0012] Preferably, the dried tangerine peel and dried plum are soaked before the first extraction; the soaking time is 30 minutes.

[0013] Preferably, the drying conditions are 50°C for 60 minutes.

[0014] The present invention also provides tangerine peel and dried plum effervescent tablets prepared by the above preparation method.

[0015] This invention also provides the application of the above-mentioned tangerine peel and dried plum effervescent tablets in the preparation of health products for relieving or treating functional dyspepsia.

[0016] This invention also provides the application of the above-mentioned tangerine peel and dried plum effervescent tablets in the preparation of medicines for relieving or treating functional dyspepsia.

[0017] The present invention also provides the application of the above-mentioned tangerine peel and dried plum effervescent tablets in the preparation of medicines for relieving or treating cough.

[0018] Compared with the prior art, the beneficial effects of the technical solution of the present invention are as follows: This invention employs a separate wet granulation process using acid and alkali sources, replacing direct compression of dry powder to address the issue of poor flowability. This results in effervescent tablets made from tangerine peel and dried plum, which balance disintegration efficiency, stability, and palatability, while effectively preserving the active ingredients of both tangerine peel and dried plum. The effervescent tablets prepared by this invention rapidly disintegrate upon contact with water, generating numerous bubbles that quickly disperse and uniformly dissolve the active ingredients, leaving no significant sediment residue. This significantly improves the body's absorption efficiency of the active ingredients. It also overcomes the shortcomings of traditional tangerine peel and dried plum products, such as susceptibility to moisture absorption, spoilage, and short shelf life.

[0019] The effervescent tablets prepared by this invention have a small volume, light weight, and good sealing properties. The tangerine peel and dried plum complement each other in the effervescent tablet system. The qi-regulating and spleen-strengthening effects of tangerine peel enhance the regulatory effect of dried plum on intestinal function, while the lung-astringent and cough-suppressing properties of dried plum assist tangerine peel in relieving respiratory discomfort, forming a dual synergistic effect of "promoting digestion and suppressing cough." This significantly improves symptoms such as indigestion, dry throat, and cough compared to single ingredients or traditional formulations. Attached Figure Description

[0020] Figure 1 Results of a single-factor experiment on the addition amounts of citric acid and sodium bicarbonate; Figure 2 Results of a single-factor experiment on the ratio of acid source to alkali source; Figure 3 Results of a single-factor experiment on lubricant addition amount; Figure 4 Results of single-factor experiments on the content of the main drug; Figure 5 Results of a single-factor experiment on diluent content; Figure 6 Results of a single-factor experiment on the amount of mogrosides added; Figure 7 Venn diagram of the main component genes of tangerine peel and dried plum effervescent tablets and their targets in functional dyspepsia; Figure 8 Venn diagram of the main component genes of tangerine peel and dried plum effervescent tablets and their targets in cough; Figure 9 : Intersection target PPI network diagram of tangerine peel and dried plum effervescent tablets and functional dyspepsia; Figure 10 : Intersecting target PPI network diagram of tangerine peel and dried plum effervescent tablets and cough; Figure 11 Bar chart showing the GO enrichment analysis of the target of functional dyspepsia in tangerine peel and dried plum effervescent tablets; Figure 12 Bar chart showing the GO enrichment analysis of tangerine peel and dried plum effervescent tablets and their target for cough action; Figure 13 Bubble diagram of KEGG pathway enrichment analysis of tangerine peel and dried plum effervescent tablets and their target for functional dyspepsia; Figure 14 Bubble diagram of KEGG pathway enrichment analysis of Chenpi Wumei effervescent tablets and cough target; Figure 15 : Drug composition and target diagram for treating functional dyspepsia with tangerine peel and dried plum; Figure 16 : Diagram of the ingredients and target points of tangerine peel and dried plum effervescent tablets for treating cough; Figure 17 Bar chart of gastric emptying rate for each group of animals; Figure 18 Bar chart of small intestinal propulsion rate in each group of animals; Figure 19 Bar chart showing the number of coughs in each group of animals; Figure 20 Bar chart showing the cough inhibition rate of each group of animals. Detailed Implementation

[0021] This invention provides a method for preparing tangerine peel and dried plum effervescent tablets, comprising the following steps: The tangerine peel and dried plum were extracted to obtain an extract; the extract was concentrated and dried to obtain tangerine peel and dried plum extract powder. The tangerine peel and dried plum extract powder was divided into two equal parts, designated as extract powder 1 and extract powder 2. Citric acid was added to extract powder 1, and it was sprayed with 9.5% povidone-ethanol solution and dried to obtain acid granules. Sodium bicarbonate was added to extract powder 2, and it was sprayed with 9.5% povidone-ethanol solution and dried to obtain alkali granules. The acid granules, alkali granules, lactose, PEG 6000 and mogroside were mixed, compressed into tablets, and dried to obtain tangerine peel and dried plum effervescent tablets.

[0022] In this invention, the tangerine peel and dried plum effervescent tablets, by weight, comprise: 10-20 parts tangerine peel and dried plum extract powder, 50-60 parts disintegrant, 3 parts lactose, 4-6 parts PEG 6000, and 4 parts mogroside; preferably, 15 parts tangerine peel and dried plum extract powder, 55 parts disintegrant, 3 parts lactose, 5 parts PEG 6000, and 4 parts mogroside. The disintegrant is citric acid and sodium bicarbonate, with a mass ratio of citric acid to sodium bicarbonate of (1.2-1.6):1, preferably 1.3:1, 1.4:1, or 1.5:1. The preferred mass ratio of tangerine peel to dried plum is 2:3.

[0023] This invention adds mogrosides, which, without affecting disintegration efficiency, produce a strong sweetness without causing an increase in blood sugar and insulin levels, and has the advantages of being natural, environmentally friendly, green and healthy.

[0024] In this invention, the tangerine peel and dried plum are preferably soaked before the first extraction; the soaking time is preferably 30 minutes, and the amount of water added during soaking is preferably the same as that added during the first extraction, i.e., extraction is performed directly after soaking. The extraction is performed three times, each time for 1 hour; the amount of water added during each extraction is preferably 1000 mL / 100g based on the total mass of the tangerine peel and dried plum. As an optional embodiment, the tangerine peel and dried plum are soaked for 30 minutes with water at a ratio of 1000 mL / 100g, then decocted for 1 hour. After cooling the decoction to room temperature, it is filtered to obtain filtrate 1 and residue 1; residue 1 is decocted with an equal amount of water for 1 hour, and the decoction is filtered after cooling to room temperature to obtain filtrate 2 and residue 2; residue 2 is decocted with an equal amount of water for 1 hour, and the decoction is filtered after cooling to room temperature to obtain filtrate 3 and residue 3; filtrate 1, filtrate 2, and filtrate 3 are combined to obtain the extract.

[0025] The present invention preferably involves concentrating the extract 60 times and drying it in an oven at 60°C for 72 hours to obtain a dry paste, which is then pulverized to obtain tangerine peel and dried plum extract powder (100 mesh).

[0026] This invention divides tangerine peel and dried plum extract powder into two equal parts, designated as extract powder 1 and extract powder 2. Citric acid is added to extract powder 1, which is then sprayed with a 9.5% povidone-ethanol solution and dried to obtain acid granules. Sodium bicarbonate is added to extract powder 2, which is then sprayed with a 9.5% povidone-ethanol solution and dried to obtain alkali granules. The acid granules, alkali granules, lactose, PEG 6000, and mogroside are mixed, compressed into tablets, and dried to obtain tangerine peel and dried plum effervescent tablets. In this invention, during the preparation of the acid granules, 0.14 mL / g of 9.5% povidone-ethanol solution is added based on the mass of the extract powder, and the drying conditions are 50°C for 60 min. During the preparation of the alkali granules, 0.08 mL / g of 9.5% povidone-ethanol solution is added based on the mass of the extract powder, and the drying conditions are 50°C for 60 min. In this invention, the tableting pressure is preferably 7 kN, the ambient temperature of the tableting machine chamber is preferably 25°C, and the humidity is preferably 55%. The invention also emphasizes timely cleaning and replacement of the punches and dies to effectively avoid the problem of punch sticking. After tableting, the tablets are dried to obtain tangerine peel and dried plum effervescent tablets. The drying conditions are 50°C for 60 minutes.

[0027] The present invention also provides tangerine peel and dried plum effervescent tablets prepared by the above preparation method.

[0028] This invention also provides the application of the above-mentioned tangerine peel and dried plum effervescent tablets in the preparation of health products / medicines for relieving or treating functional dyspepsia. The tangerine peel and dried plum effervescent tablets can effectively increase the gastric emptying rate and small intestinal propulsion rate of mice, and promote digestion.

[0029] The present invention also provides the application of the above-mentioned tangerine peel and dried plum effervescent tablets in the preparation of medicines for relieving or treating cough, wherein the tangerine peel and dried plum effervescent tablets can effectively suppress cough.

[0030] This invention employs network pharmacology to analyze the main active ingredients and targets, functional dyspepsia disease targets, and cough disease targets of Chenpi Wumei effervescent tablets. A PPI network was constructed, and GO and KEGG enrichment analyses were performed to obtain a "drug-component-target" network interaction diagram. This evidence supports the mechanism of action of Chenpi Wumei effervescent tablets in treating functional dyspepsia and cough, providing a theoretical basis for the pharmacodynamic experimental verification of Chenpi Wumei effervescent tablets in treating functional dyspepsia and cough.

[0031] The technical solutions of this invention will be clearly and completely described below with reference to the embodiments thereof. Obviously, the described embodiments are only a part of the embodiments of this invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0032] Unless otherwise specified, the following embodiments are all conventional methods.

[0033] Unless otherwise specified, all materials and reagents used in the following examples are commercially available.

[0034] Example 1 A type of tangerine peel and dried plum effervescent tablet: By weight, the raw material components are: 15 parts dried tangerine peel and dried plum extract powder, 55 parts disintegrant, 3 parts lactose, 5 parts PEG 6000 and 4 parts mogroside; the disintegrant is citric acid and sodium bicarbonate, with a mass ratio of citric acid to sodium bicarbonate of 1.4:1; the mass ratio of dried tangerine peel to dried plum is 2:3.

[0035] Preparation method: Take dried tangerine peel and dried plum, add water at a ratio of 1000 mL / 100g, soak the tangerine peel and dried plum for 30 minutes, then decoct for 1 hour. After cooling the decoction to room temperature, filter to obtain filtrate 1 and residue 1. Add an equal amount of water to residue 1 and decoct for 1 hour. After cooling the decoction to room temperature, filter to obtain filtrate 2 and residue 2. Add an equal amount of water to residue 2 and decoct for 1 hour. After cooling the decoction to room temperature, filter to obtain filtrate 3 and residue 3. Combine filtrate 1, filtrate 2 and filtrate 3 to obtain the extract. Concentrate the extract 60 times and dry it in an oven at 60℃ for 72 hours to obtain a dry paste. Pulverize to obtain tangerine peel and dried plum extract powder (100 mesh).

[0036] The tangerine peel and dried plum extract powder was divided into two equal parts, designated as extract powder 1 and extract powder 2. Citric acid was added to extract powder 1, and 9.5% povidone-ethanol solution was sprayed at 0.14 mL / g. The mixture was dried at 50°C for 60 min to obtain acid granules. Sodium bicarbonate was added to extract powder 2, and 9.5% povidone-ethanol solution was sprayed at 0.08 mL / g. The mixture was dried at 50°C for 60 min to obtain alkali granules. The acid granules, alkali granules, lactose, PEG6000 and mogroside were mixed and compressed into tablets (pressure 7 KN, ambient temperature of tableting chamber 25°C, humidity 55%). The tablets were dried at 50°C for 60 min to obtain tangerine peel and dried plum effervescent tablets.

[0037] Example 2 A type of tangerine peel and dried plum effervescent tablet: By weight, the raw material components are: 10 parts dried tangerine peel and dried plum extract powder, 50 parts disintegrant, 3 parts lactose, 4 parts PEG 6000 and 4 parts mogroside; the disintegrant is citric acid and sodium bicarbonate, with a mass ratio of citric acid to sodium bicarbonate of 1.2:1; the mass ratio of dried tangerine peel to dried plum is 2:3.

[0038] Preparation method: Take dried tangerine peel and dried plum, add water at a ratio of 1000 mL / 100g, soak the tangerine peel and dried plum for 30 minutes, then decoct for 1 hour. After cooling the decoction to room temperature, filter to obtain filtrate 1 and residue 1. Add an equal amount of water to residue 1 and decoct for 1 hour. After cooling the decoction to room temperature, filter to obtain filtrate 2 and residue 2. Add an equal amount of water to residue 2 and decoct for 1 hour. After cooling the decoction to room temperature, filter to obtain filtrate 3 and residue 3. Combine filtrate 1, filtrate 2 and filtrate 3 to obtain the extract. Concentrate the extract 60 times and dry it in an oven at 60℃ for 72 hours to obtain a dry paste. Pulverize to obtain tangerine peel and dried plum extract powder (100 mesh).

[0039] The tangerine peel and dried plum extract powder was divided into two equal parts, designated as extract powder 1 and extract powder 2. Citric acid was added to extract powder 1, and 9.5% povidone-ethanol solution was sprayed at 0.14 mL / g. The mixture was dried at 50°C for 60 min to obtain acid granules. Sodium bicarbonate was added to extract powder 2, and 9.5% povidone-ethanol solution was sprayed at 0.08 mL / g. The mixture was dried at 50°C for 60 min to obtain alkali granules. The acid granules, alkali granules, lactose, PEG6000 and mogroside were mixed and compressed into tablets (pressure 7 KN, ambient temperature of tableting chamber 25°C, humidity 55%). The tablets were dried at 50°C for 60 min to obtain tangerine peel and dried plum effervescent tablets.

[0040] Example 3 A type of tangerine peel and dried plum effervescent tablet: By weight, the raw material components are: 20 parts dried tangerine peel and dried plum extract powder, 60 parts disintegrant, 3 parts lactose, 6 parts PEG 6000 and 4 parts mogroside; the disintegrant is citric acid and sodium bicarbonate, with a mass ratio of citric acid to sodium bicarbonate of 1.6:1; the mass ratio of dried tangerine peel to dried plum is 2:3.

[0041] Preparation method: Take dried tangerine peel and dried plum, add water at a ratio of 1000 mL / 100g, soak the tangerine peel and dried plum for 30 minutes, then decoct for 1 hour. After cooling the decoction to room temperature, filter to obtain filtrate 1 and residue 1. Add an equal amount of water to residue 1 and decoct for 1 hour. After cooling the decoction to room temperature, filter to obtain filtrate 2 and residue 2. Add an equal amount of water to residue 2 and decoct for 1 hour. After cooling the decoction to room temperature, filter to obtain filtrate 3 and residue 3. Combine filtrate 1, filtrate 2 and filtrate 3 to obtain the extract. Concentrate the extract 60 times and dry it in an oven at 60℃ for 72 hours to obtain a dry paste. Pulverize to obtain tangerine peel and dried plum extract powder (100 mesh).

[0042] The tangerine peel and dried plum extract powder was divided into two equal parts, designated as extract powder 1 and extract powder 2. Citric acid was added to extract powder 1, and 9.5% povidone-ethanol solution was sprayed at 0.14 mL / g. The mixture was dried at 50°C for 60 min to obtain acid granules. Sodium bicarbonate was added to extract powder 2, and 9.5% povidone-ethanol solution was sprayed at 0.08 mL / g. The mixture was dried at 50°C for 60 min to obtain alkali granules. The acid granules, alkali granules, lactose, PEG6000 and mogroside were mixed and compressed into tablets (pressure 7 KN, ambient temperature of tableting chamber 25°C, humidity 55%). The tablets were dried at 50°C for 60 min to obtain tangerine peel and dried plum effervescent tablets.

[0043] Experimental Example 1 1. Validation of the extraction process of dried tangerine peel and dried plum extract An orthogonal experiment was conducted to explore the optimal values ​​for the number of decoctions, the amount of water added, and the decoction time. An entropy weighting method was used to perform a weighted analysis based on the content of effective ingredients and the yield of extract to obtain a comprehensive score. The number of decoctions was set as A, the decoction time as B, the amount of water added as C, and the blank as D, representing a four-factor, three-level L9(3) experiment. 4 An orthogonal array was constructed, and orthogonal experiments were conducted. Nine portions of the prescription were weighed, each containing 40g of dried tangerine peel and 60g of dried plum. The tangerine peel and dried plum were soaked for 30 minutes, and then extracted according to the extraction factor level table. The extract was filtered (if the extraction was performed 2 or 3 times, the extracts were combined), and the extract was concentrated 60 times. The extract was then dried in an oven at 60℃ for 72 hours to obtain a dry extract, and the weight of the dry extract was recorded.

[0044] Table 1. Orthogonal Factor Level Table for Extraction Process of Tangerine Peel and Dried Plum

[0045] An orthogonal experiment was conducted by selecting the number of decoctions, decoction time, and water volume. The optimal extraction process of dried tangerine peel and dried plum decoction was determined by calculating the comprehensive score based on the extract yield, total flavonoid content, and citric acid content. Standard curves were constructed based on standard solutions (total flavonoids: 0.05 mg / mL, 0.10 mg / mL, 0.15 mg / mL, 0.2 mg / mL, 0.25 mg / mL, 0.30 mg / mL; citric acid: 0.32 mg / mL, 0.64 mg / mL, 0.96 mg / mL, 1.28 mg / mL, 1.6 mg / mL). The standard curves for flavonoids and citric acid were y = 1.4448x - 0.021 (R²). 2 =0.9991), y = 0.2839x+ 0.0021 (R 2 =0.9991), all showing a linear relationship. The total flavonoid content and citric acid content in each group were obtained using the standard curve. The weights were obtained by the entropy weight method, and the comprehensive score was calculated using the formula M=(total flavonoid content / total flavonoid content max)×0.24878+(citric acid content / citric acid content max)×0.36478+(dry paste rate / dry paste rate max)×0.38643, as shown in Table 2.

[0046] Table 2 Entropy Weight Method Weight Analysis Table

[0047] The primary factor affecting this extraction process is the cooking time, followed by the amount of water added, and lastly, the cooking time. The optimal extraction process combination is A3B1C3, which is group 7 of the orthogonal experiment: 1000 mL of water is added each time for one hour of decoction, for a total of three decoctions. The yield of the extract was 48.32%. The total flavonoid content in the obtained dry extract powder was 9.44%, and the citric acid content was 2.28%. Range analysis revealed that among the three factors, the number of decoctions had a significant impact on the extraction process, as shown in Table 4.

[0048] Table 3. Orthogonal experimental design table and comprehensive score of optimal extraction process for tangerine peel and dried plum extract.

[0049] The D blank group serves as the error column, assisting in demonstrating the validity of the experiment and analysis. The D blank column represents an aqueous solution, and the procedure is the same as other groups: decoction times, time, and water volume, except without the addition of tangerine peel and dried plum extract. After extraction, the overall score is measured and calculated. In other words, "a space is reserved in the design, and it is treated as a virtual factor in the analysis, with the result used to measure the reliability of the experiment and the significance of the factor's influence." No additional operations are required.

[0050] Table 4. Analysis of Variance of Orthogonal Experiment Results for Extraction Process

[0051] 2. Preparation process of tangerine peel and dried plum effervescent tablets 2.1 Acid-base separation wet granulation method Preparation of tangerine peel and dried plum extract powder: 40 parts tangerine peel and 60 parts dried plum. Soak the tangerine peel and dried plum in water at a ratio of 1000 mL / 100g for 30 minutes, then decoct for 1 hour. Filter the decoction to obtain filtrate 1 and residue 1. Add an equal amount of water to residue 1 and decoct for 1 hour. Filter the decoction to obtain filtrate 2 and residue 2. Add an equal amount of water to residue 2 and decoct for 1 hour. Filter the decoction to obtain filtrate 3 and residue 3. Combine filtrate 1, filtrate 2, and filtrate 3, concentrate the extract 60 times, and dry in an oven at 60℃ for 72 hours to obtain a dry extract. Pulverize to obtain tangerine peel and dried plum extract powder (100 mesh).

[0052] A formulation intermediate for effervescent tablets was prepared using a wet granulation technique with separate acid and alkali preparation. Tangerine peel and dried plum extract powder was divided into two equal portions, with citric acid and sodium bicarbonate used as the acid and alkali sources, respectively. One portion was mixed with citric acid and sprayed with 0.14 mL / g of 9.5% povidone-ethanol solution to obtain acid granules; the other portion was mixed with sodium bicarbonate and sprayed with 0.08 mL / g of 9.5% povidone-ethanol solution to obtain alkali granules. The acid and alkali granules were separately dried in a drying oven at 50°C for 60 min. Lactose, mogrosides, and PEG 6000 were then added and mixed thoroughly. The mixture was then compressed into tablets, dried at 50°C for 60 min, cooled in a refrigerator at 4°C, and then sealed.

[0053] 2.2 Single-factor experiment on tangerine peel and dried plum effervescent tablets 2.2.1 Effect of the amount of disintegrants (citric acid, sodium bicarbonate) added on the preparation process of tangerine peel and dried plum effervescent tablets A single-factor comparative experiment was conducted to compare the addition amounts of citric acid and sodium bicarbonate. The addition amounts of tangerine peel and dried plum extract powder, PEG 6000, lactose, and mogrosides in the tangerine peel and dried plum effervescent tablets were fixed at 20 parts, 3 parts, and 4 parts respectively, with a citric acid:sodium bicarbonate ratio of 1.2:1. The addition amounts of citric acid and sodium bicarbonate were set at 30, 35, 40, 45, 50, 55, and 60 parts, and the disintegration time of each group was statistically analyzed. The results are as follows: Figure 1 As shown.

[0054] The results showed that the disintegrant addition level was at its lowest point at 55 parts, and the disintegration time decreased and then increased with the increase of disintegrant.

[0055] 2.2.2 Effect of the ratio of acid source to alkali source on the preparation process of tangerine peel and dried plum effervescent tablets Single-factor experiments were conducted to determine the ratio of acid and alkali sources. The total amount of citric acid and sodium bicarbonate was fixed at 50 parts, the amount of dried tangerine peel and dried plum extract powder added at 20 parts, the amount of PEG 6000 added at 3 parts, the amount of lactose added at 3 parts, and the amount of mogroside added at 4 parts. The mass ratio of citric acid to sodium bicarbonate was set to 1.0:1, 1.1:1, 1.2:1, 1.3:1, 1.4:1, 1.5:1, and 1.6:1, respectively. The disintegration time of each group was statistically analyzed, and the results are as follows: Figure 2 As shown.

[0056] The results showed that as the mass ratio of citric acid to sodium bicarbonate increased, the pH value decreased and the disintegration rate decreased. A minimum disintegration time and a relatively suitable pH value (4.23 ± 0.52) were observed at a ratio of 1.4:1.

[0057] 2.2.3 Effect of Lubricant Addition Amount on the Preparation Process of Tangerine Peel and Dried Plum Effervescent Tablets PEG 6000 was selected as the lubricant, and a single-factor experiment was conducted to determine its addition amount. The addition amounts were fixed at 20 parts of dried tangerine peel and dried plum extract powder, 3 parts of lactose, 4 parts of mogroside, and 50 parts of citric acid and sodium bicarbonate (1.2:1). When preparing the soft material, 1, 2, 3, 4, 5, 6, and 7 parts of PEG 6000 lubricant were added respectively, and the disintegration time of each group was recorded. The results are as follows: Figure 3 As shown.

[0058] The results showed that the disintegration time was lowest when the lubricant content was 5 parts. As the lubricant content increased, the disintegration time initially decreased and then increased.

[0059] 2.2.4 Effect of the dosage of the main drug on the preparation process of Chenpi Wumei effervescent tablets A single-factor experiment was conducted to determine the content of the active ingredient (extract powder of dried tangerine peel and dried plum). The addition amounts of citric acid and sodium bicarbonate (1.2:1) were fixed at 50 parts, PEG 6000 at 3 parts, lactose at 3 parts, and mogroside at 4 parts. The active ingredient was added in amounts of 10, 15, 20, 25, 30, 35, and 40 parts, respectively. The disintegration time of each group was recorded, and the results are as follows: Figure 4 As shown.

[0060] The results showed that the disintegration time decreased with increasing active ingredient content. The dry extracts of dried tangerine peel and dried plum had extremely strong adhesive properties, significantly affecting the disintegration time of effervescent tablets. Considering both the disintegration time and the taste of the solution after disintegration, an optimal active ingredient content of 15 parts was found to be suitable for effervescent tablets.

[0061] 2.2.5 Effect of diluent addition amount on the preparation process of tangerine peel and dried plum effervescent tablets A single-factor experiment was conducted to determine the amount of diluent added. The amounts of dried tangerine peel and dried plum extract powder added were fixed at 20 parts, citric acid and sodium bicarbonate (1.2:1) added at 50 parts, PEG 6000 added at 3 parts, and mogroside added at 4 parts. Lactose was added at amounts of 2, 3, 4, 5, 6, 7, and 8 parts respectively. The disintegration time of each group was recorded, and the results are as follows: Figure 5 As shown.

[0062] The results showed that the disintegration time generally increased with increasing diluent content, but the variation within the range was not significant. Furthermore, the amount of lactose added had a relatively small impact on the disintegration time; after multiple verifications, the data from each experiment under the same conditions showed some fluctuation. The optimal diluent addition for effervescent tablets was determined to be 3 parts.

[0063] 2.2.6 Effect of Monk Fruit Glycoside Addition on the Preparation Process of Tangerine Peel and Plum Effervescent Tablets A single-factor experiment was conducted to determine the optimal process for effervescent tablets. The optimal amounts of mogrosides were fixed at 20 parts of dried tangerine peel and dried plum extract powder, 50 parts of citric acid and sodium bicarbonate (1.2:1), 3 parts of PEG 6000, and 3 parts of lactose. Mogrosides were added in amounts of 1, 2, 3, 4, 5, 6, and 7 parts respectively. Each batch was then diluted with 150 mL of cooled boiled water. A 10-person evaluation panel scored the samples based on taste, with 7-10 points for moderate acidity and sweetness, 5-6 points for slightly acidic and sweet, 2-4 points for moderately acidic and sweet, and 1 point for extremely acidic and extremely sweet. This determined the optimal amount of mogrosides. The results are as follows: Figure 6 As shown.

[0064] The results showed that mogrosides are 300 times sweeter than sucrose. Increasing the amount of mogrosides resulted in a taste that initially increased and then decreased. The best overall evaluation was achieved when the amount added was 4 parts.

[0065] Through orthogonal experiments on the extraction process and single-factor experiments on the amount of excipients added, the optimal process was finally determined as follows: 40 parts dried tangerine peel and 60 parts dried plum. Soak the tangerine peel and dried plum in water at a ratio of 1000 mL / 100g for 30 minutes, then decoct for 1 hour. After cooling the decoction to room temperature, filter to obtain filtrate 1 and residue 1. Add an equal amount of water to residue 1 and decoct for 1 hour. After cooling the decoction to room temperature, filter to obtain filtrate 2 and residue 2. Add an equal amount of water to residue 2 and decoct for 1 hour. After cooling the decoction to room temperature, filter to obtain filtrate 3 and residue 3. Combine filtrate 1, filtrate 2, and filtrate 3, concentrate the extract 60 times, and dry in an oven at 60℃ for 72 hours to obtain a dry extract. Pulverize to obtain tangerine peel and dried plum extract powder (100 mesh).

[0066] Take 15 parts of dried tangerine peel and dried plum extract powder and divide them into two equal parts. Add citric acid to one part and spray with 0.14 ml / g of 9.5% povidone-ethanol solution to prepare acid granules; add sodium bicarbonate to the other part and spray with 0.08 ml / g of 9.5% povidone-ethanol solution to prepare alkali granules. The total amount of citric acid and sodium bicarbonate is 55 parts, with a ratio of 1.4:1. Place the acid and alkali granules in an electric thermostatic drying oven at 50℃ and dry for 1 hour. Then add 5 parts of PEG 6000, 4 parts of mogroside, and 3 parts of lactose, mix well, and compress into tablets. Dry in an electric thermostatic drying oven at 50℃ for 1 hour, then cool and seal in a 4℃ refrigerator to obtain the test drug.

[0067] 3. Network pharmacological efficacy prediction of tangerine peel and dried plum effervescent tablets 3.1 Detection of drug components and targets Chemical information for dried tangerine peel and dried plum was retrieved using the TCMSP database. Components of dried tangerine peel and dried plum were obtained through screening based on oral bioavailability (OB) ≥30.0% and drug-likeness (DL) ≥0.18. The SMILES numbers of these components were then entered into the Swisstarget prediction database for target prediction. After deduplication, a total of 304 targets were predicted for the traditional Chinese medicine targets of dried tangerine peel and dried plum.

[0068] 3.2 Disease Target Prediction ① Using the GeneCards and Disgent databases, we searched for disease-related targets (functional dyspepsia) using "Functional Dyspepsia" as the keyword. We set the species as human, removed targets with a score less than 0.35 from the GeneCards database, obtained the target genes for the disease (functional dyspepsia), and then took the intersection of the disease targets retrieved from the databases to remove duplicate values, resulting in 1804 disease (functional dyspepsia) targets.

[0069] ② Using the GeneCards and TTD databases, we searched for disease (cough) related targets with "cough" as the keyword. We set the species to human, removed the targets with a score less than 1 in the GeneCards database, obtained the disease (cough) target genes, and then took the intersection of the disease targets retrieved from the database to remove duplicate values, resulting in 2086 disease (cough) targets.

[0070] 3.3 Intersection Target Analysis ① The screened compound targets and functional dyspepsia disease targets were input into Venny 2.1.0 plotting software, resulting in 123 common targets, as shown in the figure. Figure 7 As shown, it serves as a predictive target for the compound's action on the disease for subsequent analysis.

[0071] ② The screened compound targets and cough disease targets were input into Venny 2.1.0 plotting software, resulting in 147 common targets, as shown in the figure. Figure 8 As shown, it serves as a predictive target for the compound's action on the disease for subsequent analysis.

[0072] 3.4 Protein-protein interaction analysis Common drug-disease targets were input into the STRING database to construct a PPI network. The biological species were set to "Homosapiens," and the minimum required interaction score was set to 0.40. The PPI network was then visualized using Cytoscape software. Analysis revealed targets ranked by degree value; darker colors indicated a stronger correlation between the drug and the disease target.

[0073] The intersection target PPI network diagram of tangerine peel and dried plum effervescent tablets and functional dyspepsia is shown below. Figure 9 As shown, the PPI network diagram of the intersection target of tangerine peel and dried plum effervescent tablets and cough is as follows. Figure 10 As shown. Screening of PPI core targets revealed that the key gene targets involved in the treatment of FD and cough with Chenpi Wumei effervescent tablets include AKT1, EGFR, BCL2, ESR1, and SRC. Among these, AKT1 is involved in glucose uptake and utilization, glycogen and protein synthesis, cell proliferation, DNA repair, and inhibition of apoptosis. EGFR has tyrosine activity and is one of the epidermal growth factor receptors on the cell surface. Activated by epidermal growth factor (EGF), it affects cell growth and differentiation. In gastric mucosa tissue, both EGF and EGFR are expressed at high levels, which is significantly correlated with their role in the healing process of gastric ulcers; furthermore, their effective binding can increase gastric mucosal blood flow, thus playing a crucial role in the repair of damaged mucosa. BCL2 is an important regulator of programmed cell death pathways, possessing an anti-apoptotic mechanism and is also an important pro-survival protein, playing a vital role in normal immunity. ESR1 is estrogen receptor 1. Studies have shown that metabolic disorders in male rats with ESR1 gene knockout are related to the loss of transcriptional regulation of ESR1 in the liver, and the mechanism of action is related to hepatic carbohydrate and lipid metabolism regulators. Other studies have shown that SRC can promote and participate in the survival, proliferation, migration, and angiogenesis of gastric cancer cells, and can also interact with various cytokines, adhesion factors, and cytoskeleton components.

[0074] 3.5 Enrichment Analysis We used the David database to perform enrichment analysis on the communication targets between drugs and diseases, and then visualized the enrichment results using the MicroBio platform.

[0075] The bar chart shows the GO enrichment analysis of the target of functional dyspepsia in tangerine peel and dried plum effervescent tablets. Figure 11 As shown in the bar chart, the GO enrichment analysis of the tangerine peel and dried plum effervescent tablets and the target of cough action is as follows: Figure 12 As shown in the bubble diagram, the KEGG pathway enrichment analysis of the target of functional dyspepsia using tangerine peel and dried plum effervescent tablets is as follows. Figure 13 As shown in the bubble diagram of KEGG pathway enrichment analysis of Chenpi Wumei effervescent tablets and cough target, the results are as follows: Figure 14 As shown.

[0076] Functional dyspepsia: GO functional enrichment analysis and KEGG pathway enrichment analysis were performed on effective active targets using the DAVID database and the MicroBio platform. A total of 708 GO entries were obtained by screening with a P < 0.05 condition, including 449 BP entries, 80 CC entries, and 179 MF entries. The top 10 entries were selected for each category and plotted as a bar chart with a P < 0.05 condition. KEGG pathway enrichment analysis was then performed, and 142 pathways were obtained by screening with a P < 0.05 condition. The top 20 pathways were selected and plotted as a bubble chart. GO and KEGG pathway analyses revealed a high number of genes enriched in pathways such as EGFR and phosphatidylinositol 3-kinase-protein kinase B (PI3K / AKT). Studies have shown that EGFR can promote the growth and development of gastrointestinal tissues, repair damaged mucosa, and improve the digestion and absorption of nutrients. The PI3K / AKT pathway is mainly involved in the proliferation, invasion, metastasis, apoptosis, and angiogenesis of gastric cancer cells. Chenpi Wumei effervescent tablets may improve gastrointestinal function and treat functional dyspepsia by regulating the PI3K / AKT signaling pathway.

[0077] Cough: GO functional enrichment analysis and KEGG pathway enrichment analysis were performed on effective active targets using the DAVID database and the MicroBio platform. A total of 675 GO entries were obtained by screening with a P < 0.05 condition, including 319 BP entries, 43 CC entries, and 33 MF entries. The top 10 entries were selected for bar charting with a P < 0.05 condition. KEGG pathway enrichment analysis was then performed, and 147 pathways were obtained by screening with a P < 0.05 condition. The top 20 pathways were selected for bubble charting. Combining GO and KEGG analyses revealed that biological processes related to inflammatory responses and immune regulation, as well as signaling pathways such as PI3K-AKT, were significantly enriched in cough-related genes. This study indicates that IL-17 participates in the occurrence and development of cough by promoting airway inflammation and excessive mucus secretion. Inhibiting the pathological effects of IL-17 may be a potential therapeutic strategy for alleviating related cough symptoms. The PI3K / AKT pathway is mainly involved in the regulation of increased cough reflex sensitivity, airway inflammatory response, and neurogenic inflammation. Chenpi Wumei effervescent tablets may alleviate cough symptoms by inhibiting the PI3K / AKT signaling pathway and reducing the expression of pro-inflammatory factors.

[0078] 3.6 Drug-Component-Target Diagram To further explore the interactions between the drug, components, and targets of Chenpi Wumei effervescent tablets, a drug-component-target network was constructed using Chenpi (dried tangerine peel), Wumei (dried plum), and their respective components and targets as a basis. This network diagram visually revealed the relationships between the traditional Chinese medicine, components, and targets, suggesting that Chenpi Wumei effervescent tablets may exert a therapeutic effect on functional dyspepsia through multiple targets.

[0079] A diagram illustrating the components and target points of a drug for treating functional dyspepsia using dried tangerine peel and dried plum. Figure 15 As shown; the drug-ingredient-target diagram of Chenpi Wumei effervescent tablets for treating cough is as follows. Figure 16 As shown.

[0080] Figure 15 The results showed that, through drug-component-target network analysis, 13 active ingredients acted on 304 drug targets. The top four Degree rankings were methyl arachidonic acid, quercetin, kaempferol, and naringenin, which are the main active ingredients in Chenpi Wumei effervescent tablets for treating functional dyspepsia, with methyl arachidonic acid having the highest Degree. Methyl arachidonic acid, quercetin, and kaempferol are derived from dried plum (dried plum). Studies have shown that kaempferol can significantly reduce serum interleukin-6 levels in experimental animals, inhibit the expression of interleukin-1β and tumor necrosis factor-α in macrophages, and has a certain anti-inflammatory effect on inflammation caused by Helicobacter pylori infection. Naringenin is derived from dried tangerine peel (Chenpi). Studies have shown that naringenin has pharmacological effects such as promoting gastrointestinal motility, antispasmodic, anti-inflammatory, and antioxidant effects, and has a regulatory effect on intestinal motility. Naringenin can also inhibit the pacing of small intestinal Cajal interstitial cells (ICC) and spontaneous contractions of the colon.

[0081] Figure 16 The results showed that, through drug-component-target network analysis, 13 active ingredients acted on 108 drug targets. The top four Degree rankings were quercetin, kaempferol, β-sitosterol, and naringenin, which are the main active ingredients in Chenpi Wumei effervescent tablets for treating cough, with quercetin having the highest Degree. Quercetin, kaempferol, and β-sitosterol are derived from dried plum (dried plum). Studies have shown that quercetin can significantly reduce the levels of interleukin-6 and tumor necrosis factor-α in the bronchoalveolar lavage fluid of rats with acute bronchitis, inhibit the infiltration of inflammatory cells such as neutrophils and eosinophils, and improve airway inflammatory responses, thereby alleviating cough symptoms. Naringenin is derived from dried tangerine peel (Chenpi). Studies have shown that quercetin has antitussive, expectorant, anti-pulmonary inflammation, and anti-pulmonary fibrosis effects, and has significant therapeutic effects on respiratory diseases. Quercetin can also inhibit the activity of rapid airway receptors (RARs) and reduce cough sensitivity.

[0082] 4. Pharmacodynamic verification of tangerine peel and dried plum effervescent tablets in the treatment of functional dyspepsia 4.1. Grouping After one week of acclimatization, the female and male mice were randomly divided into 6 groups of 8 mice each, ensuring that each group had half males and half females. The animals were then used to establish a functional dyspepsia model.

[0083] 4.2 Modeling Method A functional dyspepsia (FD) animal model was established using an irregular feeding method combined with L-arginine (L-Arg). Specifically, a cycle of 2 days of feeding followed by 1 day of fasting was used, with 10 days of cycles. On days 11 and 12, mice were intraperitoneally injected with 0.1 g / kg (L-Arg). The normal control group received normal feeding, but the same volume of physiological saline was injected intraperitoneally instead. After model establishment, 6 mice were randomly selected and sacrificed. A decrease in gastric emptying rate and small intestinal propulsion rate was considered a successful FD model. The positive control group received domperidone tablets dissolved in distilled water at a dose of 4.55 mg / kg via gavage. The low, medium, and high dose groups of tangerine peel and plum effervescent tablets were administered tangerine peel and plum effervescent tablets dissolved in distilled water via gavage, with doses of 1.52 g / kg (high dose), 0.76 g / kg (medium dose), and 0.38 g / kg (low dose), respectively. The normal control group and the model group received the same volume of physiological saline. The research content and process adhered to ethical standards.

[0084] 4.3 Measurement of gastrointestinal motility Mice were administered the drug continuously for 15 days. On the 15th day, after gavage administration, mice in each group were fasted but allowed free access to water for 12 hours. All mice were then administered 0.2 mL of 10% activated charcoal suspension by gavage. After 30 minutes, they were anesthetized and euthanized. The abdominal cavity was quickly opened, the gastric cardia and pylorus were ligated, and a total gastrectomy was performed. The total stomach weight was accurately measured. The stomach body was cut along the greater curvature, and the stomach contents were washed away with 0.9% physiological saline. The empty stomach was dried with filter paper and weighed. The gastric emptying rate was calculated as follows: D = [1 − (M − m)M] × 100%; In the formula: D is the gastric emptying rate, %; M is the total stomach mass, g; m is the empty stomach mass, g; Results of gastric emptying rate experiment as follows Figure 17As shown, the results indicated that compared with the model group, the gastric emptying rate of the normal group (72.54±5.18)% was significantly higher than that of the model group (45.94±2.3)%, with a statistically significant difference, thus confirming the establishment of the functional dyspepsia model. The gastric emptying rate of the positive control group (domperidone) was (68.72±5.45)%, significantly higher than that of the model group, with a statistically significant difference. There was no significant difference in gastric emptying rate between the low-dose group and the model group of the tangerine peel and plum effervescent tablets. The gastric emptying rate of the medium-dose group was (52.03±1.53)%, significantly higher than that of the model group, with a statistically significant difference. The gastric emptying rate of the high-dose group was (57.34±1.98)%, significantly higher than that of the model group, with a statistically significant difference. These results demonstrate that tangerine peel and plum effervescent tablets are effective in increasing gastric emptying rate in mice and can promote digestion.

[0085] Take a whole segment of small intestine from the pylorus to the ileocecal junction, lay it flat on white filter paper, and measure the distance the charcoal powder was pushed and the total length of the small intestine using a ruler. The propulsion rate of the small intestine is calculated as follows: P = S / L × 100%; In the formula: P is the small intestine propulsion rate, %; S is the distance the charcoal powder is propelled (from the anterior end of the pylorus to the anterior end of the charcoal powder), cm; L is the total length of the small intestine (from the anterior end of the pylorus to the ileocecal junction), cm.

[0086] The experimental results of small intestine propulsion rate are as follows: Figure 18 As shown, the results indicated that compared with the model group, the small intestinal propulsion rate of the normal group (71.74±4.72)% was significantly higher than that of the model group (56.39±4.14)%, showing a statistically significant difference, thus confirming the establishment of the functional dyspepsia model. The small intestinal propulsion rate of the positive control group (domperidone) was (67.33±7.5)%, significantly higher than that of the model group, showing a statistically significant difference. There was no significant difference in small intestinal propulsion rate between the low-dose and medium-dose groups of the tangerine peel and plum effervescent tablets and the model group. However, the small intestinal propulsion rate of the high-dose group of the tangerine peel and plum effervescent tablets was (66.36±4.11)%, significantly higher than that of the model group, showing a statistically significant difference. These results demonstrate that the tangerine peel and plum effervescent tablets are effective in increasing the small intestinal propulsion rate in mice.

[0087] 5. Pharmacodynamic verification of tangerine peel and dried plum effervescent tablets for treating cough 5.1 Grouping and Dosing Mice were placed in an inverted 250 mL beaker containing cotton balls soaked in 25% ammonia to induce coughing. The main signs of coughing in mice included open mouth, abdominal contractions, and a coughing sound. After 30 seconds, the mice were quickly placed in an inverted 1 L beaker for 2 minutes to observe whether the 25% ammonia solution could induce coughing (coughing symptoms: open mouth, abdominal contractions, and a coughing sound).

[0088] Mice that did not cough within 2 minutes were discarded. Forty-eight qualified mice were randomly divided into four groups: a blank control group, a model group, a Ma Xing Zhi Ke Pian (0.34 g / kg) group, a high-dose Chen Pi Wu Mei effervescent tablet group (1.52 g / kg), a medium-dose Chen Pi Wu Mei effervescent tablet group (0.76 g / kg), and a low-dose Chen Pi Wu Mei effervescent tablet group (0.38 g / kg), with eight mice in each group. The blank control group and the model group were administered an equal volume of physiological saline by gavage. The Ma Xing Zhi Ke Pian group, the high-dose Chen Pi Wu Mei effervescent tablet group, the medium-dose Chen Pi Wu Mei effervescent tablet group, and the low-dose Chen Pi Wu Mei effervescent tablet group were administered the corresponding drugs by gavage (0.1 ml / 10 g) once daily for 7 consecutive days.

[0089] 5.2 Detection methods and detection indicators One hour after administration on day 7, mice in each group were placed in an inverted 250mL beaker containing cotton balls soaked in 25% ammonia. Timing was started, and after 30 seconds, the mice were quickly placed in an inverted 1L beaker for 2 minutes. The number of coughs during the latency period (from the start of the first cough) and within 2 minutes was observed and recorded, and the cough suppression rate of the mice was calculated.

[0090] Inhibition rate (%) = (number of coughs in model group mice - number of coughs in drug-treated group mice) / number of coughs in model group mice × 100%.

[0091] The number of coughs in each group of animals as follows Figure 19 As shown, the cough suppression rate is as follows: Figure 20 As shown in the figure. Compared with the model group, the number of coughs within 2 minutes was significantly reduced in the Ma Xing Zhi Ke Pian group, the high-dose group, the medium-dose group, and the low-dose group of Chen Pi Wu Mei effervescent tablets, and the cough suppression rate was significantly increased, showing statistically significant differences.

[0092] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A preparation method of a Shengpi Wumei effervescent tablet, characterized in that, The method comprises the following steps: extracting Chenpi and Wumei to obtain an extract solution; concentrating and drying the extract solution to obtain Chenpi Wumei extract powder; dividing the Chenpi Wumei extract powder into two equal parts, and marking them as extract powder 1 and extract powder 2; adding citric acid to the extract powder 1, spraying a 9.5% povidone-ethanol solution, and drying to obtain acid particles; adding sodium bicarbonate to the extract powder 2, spraying a 9.5% povidone-ethanol solution, and drying to obtain alkali particles; mixing the acid particles, the alkali particles, lactose, PEG 6000, and mogroside to obtain Chenpi Wumei effervescent tablets.

2. The production method according to claim 1, characterized by, The Chenpi Wumei effervescent tablets comprise, by mass fraction, 10-20 parts of Chenpi Wumei extract powder, 50-60 parts of disintegrating agent, 3 parts of lactose, 4-6 parts of PEG 6000, and 4 parts of mogroside; the disintegrating agent is citric acid and sodium bicarbonate, and the mass ratio of the citric acid to the sodium bicarbonate is (1.2-1.6):

1.

3. The preparation method according to claim 1, characterized in that, The mass ratio of the Chenpi to the Wumei is 2:

3.

4. The production method according to claim 1, characterized by, The extraction is performed for 3 times, each time for 1 h, and the amount of water added each time is 1000 mL / 100 g based on the total mass of the Chenpi and the Wumei.

5. The preparation method according to claim 4, characterized in that, The Chenpi and the Wumei are soaked before the first extraction, and the soaking time is 30 min.

6. The method of claim 1, wherein, The drying condition is 50°C for 60 min.

7. The Chenpi Wumei effervescent tablets prepared by the preparation method of any one of claims 1-6.

8. The use of the Chenpi Wumei effervescent tablets of claim 7 in the preparation of health products for relieving or treating functional dyspepsia.

9. The use of the Chenpi Wumei effervescent tablets of claim 7 in the preparation of drugs for relieving or treating functional dyspepsia.

10. The use of the Chenpi Wumei effervescent tablets of claim 7 in the preparation of drugs for relieving or treating cough.

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