Plant synergistic composition for clearing lung-heat, moistening dryness, relieving cough and reducing sputum and application thereof

Abstract

The invention relates to the technical field of pharmacy, and discloses a plant synergistic composition for clearing away lung-heat, moistening dryness, relieving cough and reducing sputum and application of the plant synergistic composition. 5-10 parts of turmeric; 8-15 parts of sophora flower bud powder; 8 to 12 parts of stachyose; 5-10 parts of purple perilla powder; 8-12 parts of fructus momordicae powder; 15 to 25 parts of anhydrous dextrose; the folium eriobotryae powder is subjected to cellulase enzymolysis treatment, and the enzymolysis conditions are as follows: the enzyme activity of cellulase is 4000-6000 U / g, the pH value is 4.0-6.0, the temperature is 40-60 DEG C, and the time is 1-3 hours; the molar ratio of the turmeric to the beta-cyclodextrin is 1: (1.5-2.5), and the embedding process conditions are as follows: the temperature is 40-60 DEG C, the stirring speed is 200-500rpm, and the time is 1-3 hours. By accurately controlling the particle size of the atomized dry powder, optimizing the carrier material, improving the coating process and accurately regulating and controlling the dosage of the stachyose, the targeted therapeutic effect and bioavailability of the medicine are effectively improved.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceuticals, and specifically to a plant synergistic composition for clearing the lungs, moistening dryness, relieving cough and resolving phlegm, and its application. Background Art

[0002] With the increasing incidence of respiratory diseases and intestinal-related diseases, the research on drug delivery systems has gradually become an important direction in the pharmaceutical field. In particular, dry powder aerosol formulations and prebiotic-related therapeutic products have shown great potential in improving drug targeted therapy and bioavailability. Dry powder aerosol formulations can act directly on the lungs through aerosol inhalation, while prebiotics such as stachyose are widely used to regulate the intestinal flora and promote the enhancement of immune function. However, the existing technologies still face some technical bottlenecks in the applications of these two fields, which affect their curative effects and the stability of clinical applications.

[0003] Existing dry powder aerosol formulations often face problems such as uneven particle size distribution and low deposition rate. Due to the lack of precise particle size control, the particle sizes of many powder formulations are too large or uneven, resulting in ineffective deposition of drugs deep into the lungs during inhalation, reducing the therapeutic effect. In addition, powder carrier materials such as lactose in the existing technologies often have poor fluidity and caking problems, resulting in uneven distribution of the powder in the dry powder inhaler, further affecting the accuracy of the dose and the curative effect of the drug. In the aspect of enteric-coated preparations, traditional coating technologies have great defects in controlling the uniformity and disintegration time of the coating layer. Excessive embedding temperature often causes drug crystallization, affecting its disintegration performance and resulting in instability of drug release. For the application of prebiotics, although stachyose has been proven to be beneficial to the intestinal flora, its dosage control is inaccurate, and it often fails to stably play a regulatory role, affecting the proliferation of the flora and the overall function of the immune system. Therefore, there are still significant deficiencies in the particle size control of drugs, the fluidity of carriers, the stability of coatings, and the precision of prebiotic dosages in the existing technologies, and these problems directly affect the effect of drug delivery and the stability of clinical curative effects. Summary of the Invention

[0004] In view of the deficiencies of the existing technologies, the present invention provides a plant synergistic composition for clearing the lungs, moistening dryness, relieving cough and resolving phlegm, and its application, which solves the problems of uneven particle size of dry powder aerosols, poor powder fluidity, unstable coating layer, and inaccurate prebiotic dosage control in the existing technologies.

[0005] To achieve the above objectives, the present invention is realized through the following technical solutions: A plant synergistic composition for clearing the lungs, moistening dryness, relieving cough and resolving phlegm, and its application, comprising the following components in parts by mass: 10 - 20 parts of loquat leaf powder; 5 - 10 parts of turmeric; 8 - 15 parts of sophora flower powder; 8 - 12 parts of stachyose; 5 - 10 parts of perilla powder; 8 - 12 parts of momordica grosvenori fruit powder; 15 - 25 parts of anhydrous glucose.

[0006] Preferably, the loquat leaf powder is treated by cellulase hydrolysis, and the hydrolysis conditions include: the cellulase activity is 4000 - 6000 U / g, pH is 4.0 - 6.0, temperature is 40 - 60 °C, and time is 1 - 3 hours.

[0007] Preferably, the molar ratio of turmeric to β - cyclodextrin is 1:1.5 - 2.5, and the embedding process conditions are: temperature is 40 - 60 °C, stirring rate is 200 - 500 rpm, and time is 1 - 3 hours.

[0008] Preferably, the perilla powder is treated by lactic acid bacteria fermentation, and the fermentation conditions include: the inoculation amount of lactobacillus plantarum is 2 - 5%, temperature is 30 - 40 °C, and time is 36 - 72 hours.

[0009] Preferably, the dosage form of the composition is a multi - layer tablet, including: Outer quick - release layer: containing loquat leaf powder and momordica grosvenori fruit powder; Inner sustained - release layer: containing turmeric inclusion complex and sophora japonica powder.

[0010] Preferably, the sustained - release layer is coated with hydroxypropyl methylcellulose, and the coating weight gain is 2 - 6%.

[0011] Preferably, the preparation method of the composition includes the following steps: a) Enzymatic hydrolysis treatment of loquat leaves; b) Fermentation treatment of perilla powder; c) Encapsulation of turmeric; d) Gradient mixing of each component.

[0012] Preferably, in step a), after enzymatic hydrolysis, it is inactivated at 80 - 90 °C for 10 - 20 minutes, and in step c), the inclusion complex is freeze - dried, the temperature is - 35 °C to - 50 °C, and the vacuum degree is 5 - 20 Pa.

[0013] The application of a plant synergistic composition for clearing the lung, moistening dryness, relieving cough and resolving phlegm, and the composition is used for preparing food, health products or drugs, and is suitable for relieving symptoms such as cough, excessive phlegm and dry throat.

[0014] The present invention provides a plant synergistic composition for clearing the lung, moistening dryness, relieving cough and resolving phlegm and its application. It has the following beneficial effects: 1. The present invention adopts a technical solution for precisely controlling the particle size. By adjusting the particle size distribution of the atomized dry powder, the powder can be better deposited in the deep lungs during inhalation, achieving a more efficient targeted therapeutic effect. Compared with the prior art solutions that lack strict control over the particle size, the present invention effectively solves the problems of uneven particle deposition and low deposition rate, and significantly improves the bioavailability of the drug.

[0015] 2. The present invention optimizes the fluidity of the powder by introducing a lactose carrier. Using a carrier material with good fluidity not only improves the stability of the powder but also reduces the probability of clogging of the nebulizer. Different from the prior art solutions that use unstable or poorly flowing carriers, the design of the present invention effectively solves the problems of uneven powder dispersion and unstable filling amount during the operation of the dry powder inhaler.

[0016] 3. The present invention adopts a technical solution for precisely proportioning stachyose, breaking through the instability of flora regulation brought about by conventional doses and optimizing the proliferation effect of intestinal flora. Compared with the prior art solutions that do not precisely control the content of stachyose, the present invention effectively solves the problem of insufficient dosage in the use of intestinal prebiotics, improves the effect of prebiotics, and promotes the overall function of respiratory immunity by regulating the flora. Description of the Drawings

[0017] Figure 1 It is a flowchart of the method steps of the present invention. Detailed Embodiments

[0018] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the drawings of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0019] Please refer to the attached Figure 1 , The embodiment of the present invention provides a plant synergistic composition for clearing the lungs, moistening dryness, relieving cough and resolving phlegm and its application, including the following components in parts by mass: Loquat leaf powder 10 - 20 parts; Turmeric 5 - 10 parts; Sophora japonica powder 8 - 15 parts; Stachyose 8 - 12 parts; Perilla powder 5 - 10 parts; Momordica grosvenori powder 8 - 12 parts; Anhydrous glucose 15 - 25 parts.

[0020] 1. Pretreatment of raw materials and enhancement of component activity Perform enzymatic hydrolysis and fermentation pretreatment on raw materials such as loquat leaves and perilla, breaking the plant cell wall structure and transforming low-efficiency components.

[0021] Enzymatic hydrolysis of loquat leaf cellulose: Specifically degrade lignin and hemicellulose in the cell wall through cellulase (4000 - 6000U / g), release the encapsulated triterpenoid antitussive components (such as oleanolic acid), and increase its dissolution rate to more than 1.5 times that of the traditional pulverization process. Optimization of the enzymatic hydrolysis conditions (pH 4.0 - 6.0, temperature 40 - 60°C) can avoid the destruction of thermosensitive components by high temperature.

[0022] Fermentation of perilla by lactic acid bacteria: Use Lactobacillus plantarum to convert perillaldehyde into perillyl alcohol, which not only reduces the risk of sensitization but also enhances the anti-inflammatory activity. Organic acids (such as lactic acid) produced during the fermentation process can further promote the dissolution of flavonoids and enhance the antioxidant capacity.

[0023] 2. Stabilization of active ingredients and co - encapsulation Use β - cyclodextrin to encapsulate curcumin and combine with the low - temperature ultrafine pulverization process to retain the activity of thermosensitive components.

[0024] Encapsulation of curcumin - β - cyclodextrin: Embed curcumin into the cavity structure of β - cyclodextrin through intermolecular hydrophobic forces (molar ratio 1:1.5 - 2.5) to form a stable encapsulation complex. This structure can resist light and oxidative degradation, and the retention rate of curcumin during storage exceeds 90% (less than 70% in the conventional process).

[0025] Low - temperature ultrafine pulverization: Under nitrogen protection, control the pulverization temperature ≤40°C, and reduce the particle size of raw materials such as sophora japonica and momordica grosvenori to 45 - 50μm. This process reduces the damage to components such as rutin and mogroside caused by heat generated by friction, and at the same time increases the specific surface area to improve the subsequent mixing uniformity.

[0026] 3. Gradient ratio and dosage form targeted design Design multi - layer tablets by functional stratification, with a quick - release antitussive component in the outer layer and a sustained - release anti - inflammatory substance in the inner layer.

[0027] Quick - release and sustained - release synergy: The outer quick - release layer (loquat leaf powder, momordica grosvenori powder) rapidly disintegrates in water (30 - 60 seconds). Through the bitterness inhibition of naringin and the mucosal adhesion of carbomer, local drug enrichment is formed in the throat to quickly relieve dry cough; the inner sustained - release layer (curcumin encapsulation, sophora japonica powder) is coated with HPMC and continuously releases in gastrointestinal fluid for 12 hours to inhibit the NF - κB inflammatory pathway.

[0028] Respiratory targeting of atomized dry powder: Mix the composition with a lactose carrier (particle size 1 - 5μm) and adapt it to a dry powder inhaler. Micronization treatment enables the drug to be directly deposited in the bronchi and alveoli, bypassing the first - pass effect of the liver and improving the pulmonary bioavailability.

[0029] 4. Functional Excipients and Systemic Regulation Add naringin (bitter taste inhibitor) and carbomer (mucosal adhesive) to optimize palatability and drug residence time.

[0030] Bitter-Antioxidant Synergy: Naringin masks the pungent bitter taste of curcumin by blocking the signal pathway of bitter receptors (T2R family); at the same time, as a polyphenol, it synergistically scavenges free radicals with curcumin to enhance the antioxidant network.

[0031] Mucosal Adhesion-Microbial Community Regulation Linkage: Carbomer forms a hydrogel layer in the throat, prolonging the drug residence time to more than 2 hours; stachyose promotes the proliferation of intestinal Bifidobacterium, activates the systemic immune response, and forms a "local-system" dual protection mechanism.

[0032] 5. Preparation Process and Quality Control Ensure the homogeneity of components through gradient mixing and freeze-drying processes, and strictly monitor the content of active ingredients using detection methods such as HPLC.

[0033] Three-Dimensional Gradient Mixing: Mix in stages according to the polarity of components (anhydrous glucose → loquat leaf powder → curcumin inclusion complex), avoid the dust loss of low-density powders (such as stachyose), and ensure that the content deviation of the final product is ≤5%.

[0034] Freeze-Drying Active Retention: Dry the inclusion complex under the conditions of -35°C to -50°C and 10 - 20 Pa to avoid the precipitation of curcumin crystals and maintain its high solubility in the amorphous state.

[0035] Example 1: Preparation of Multilayer Sustained-Release Tablets 1. Raw Material Pretreatment Enzymatic Hydrolysis Treatment of Loquat Leaves Raw Materials: Dried Loquat Leaves (Water Content ≤8%) Crushing Particle Size: 25 Mesh Enzymatic Hydrolysis Parameters: Cellulase Activity 5500 U / g, Solid-Liquid Ratio 1:10 (w / v), pH 5.0, Temperature 50°C, Time 2 hours Inactivation Conditions: 80°C Water Bath for 15 Minutes Drying Method: Spray Drying (Inlet Air Temperature 180°C, Outlet Air Temperature 85°C) Fermentation Treatment of Perilla Frutescens Powder Strain: Lactobacillus plantarum (Inoculation Amount 4%) Fermentation Parameters: Temperature 37°C, Time 50 hours, Water Content of Substrate Perilla Frutescens Powder ≤10% Termination Conditions: Sterilization at 105°C for 8 Minutes 2. Encapsulation of Active Ingredients Encapsulation of Curcumin Curcumin: 10 g Embedding conditions: temperature 50°C, stirring rate 350 rpm, time 2 hours Drying process: freeze-drying (-45°C, vacuum degree 12 Pa) 3. Gradient mixing and tabletting Mixing process First gradient mixing: 200 g of anhydrous glucose, 150 g of enzymatically hydrolyzed loquat leaf powder, 120 g of sophora japonica powder, three-dimensional mixing for 15 minutes (rotation speed 12 rpm) Second gradient mixing: 80 g of curcumin embedding material, 80 g of perilla fermentation powder, 100 g of monk fruit powder, mixing for 20 minutes Third gradient mixing: 100 g of stachyose, mixing for 10 minutes Tablet forming Immediate release layer: 300 g of mixed powder (45% enzymatically hydrolyzed loquat leaf powder, 35% monk fruit powder), tabletting pressure 9 kN, tablet weight 0.6 g Sustained release layer: 200 g of mixed powder (55% curcumin embedding material, 25% sophora japonica powder, 12% HPMC), coating weight gain 4% (coating solution concentration 10%) 4. Quality control Detection of active ingredients Retention rate of curcumin: 92% (detected by HPLC, mobile phase acetonitrile: 0.1% phosphoric acid water = 50:50, flow rate 1.0 mL / min) Disintegration time Immediate release layer: 35 seconds (in pure water medium) Sustained release layer: 12-hour in vitro release (pH 6.8 phosphate buffer solution) Example 2: Preparation of atomized dry powder 1. Raw material pretreatment Low-temperature ultrafine grinding Raw materials: curcumin, sophora japonica, monk fruit powder Grinding parameters: nitrogen protection, temperature 38°C, discharge particle size 45 μm Particle size of lactose: 3 μm (detected by laser particle size analyzer, D90 ≤ 5 μm) 2. Mixing and packaging Mixing process Composition: 100 g of the mixed powder of Example 1 Mixing equipment: fluidized bed mixer (wind speed 2.5 m / s, time 25 minutes) Packaging: sealed in aluminum foil bags, each bag contains 1.0 g of atomized dry powder 3. Key parameters Particle size distribution: D90 = 4.8 μm (laser diffraction method) Flowability: Carr index 14% (meeting the requirements of inhalation preparations) Example 3: Preparation of Enteric-coated Powder (Ratio Adjustment) 1. Formula Adjustment Loquat leaf powder: 120 g (12%) Turmeric: 70 g (7%) Stachyose: 90 g (9%) Other components: Sophora japonica powder 110 g (11%), Perilla frutescens powder 60 g (6%), Momordica grosvenori fruit powder 80 g (8%), anhydrous glucose 220 g (22%) 2. Preparation Process Optimization of Curcumin Encapsulation Curcumin: 8 g Encapsulation conditions: temperature 45°C, stirring rate 400 rpm, time 1.5 hours Mixed Powder 3. Stability Test Accelerated test: 40°C / 75% humidity, stored for 3 months Retention rate of curcumin: 87% (detected by HPLC) Content of mogroside V: 93% (detected by HPLC, mobile phase methanol: water = 70:30).

[0036] Comparative Example 1: Compared with Example 1, the difference is that: the β-cyclodextrin encapsulation step is cancelled, and unencapsulated turmeric powder (with the same curcumin content) is directly used, and the rest of the preparation steps and parameters are the same.

[0037] Comparative Example 2: Compared with Example 1, the difference is that: the molar ratio of turmeric to β-cyclodextrin is adjusted to 1:1.2 (outside the range of the claim 1:1.5 - 2.5), and the rest of the preparation steps and parameters are the same.

[0038] Comparative Example 3: Compared with Example 1, the difference is that: the pH of the loquat leaf enzymatic hydrolysis treatment is adjusted to 7.0 (outside the range of the claim pH 4.0 - 6.0), and the rest of the preparation steps and parameters are the same.

[0039] Comparative Examples Corresponding to Example 2 Comparative Example 4: Compared with Example 2, the difference is that: the particle size D90 of the lactose carrier of the atomized dry powder is 8 μm (outside the range of the claim D90 ≤ 5 μm), and the rest of the preparation steps and parameters are the same.

[0040] Comparative Example 5: Compared with Example 2, the difference is that: the lactose carrier is not used, and the composition powder is directly sub-packed, and the rest of the preparation steps and parameters are the same.

[0041] Comparative Examples Corresponding to Example 3 Comparative Example 6: Compared with Example 3, the difference lies in that the embedding temperature of curcumin is adjusted to 65°C (outside the range of 40 - 60°C in the claims), and the remaining preparation steps and parameters are the same.

[0042] Comparative Example 7: Compared with Example 3, the difference lies in that the addition amount of stachyose is adjusted to 5% (outside the range of 8 - 12% in the claims), and the remaining preparation steps and parameters are the same.

[0043] Experimental Example 1: Stability of Active Ingredients and Process Verification Experimental Purpose: To verify the effects of β-cyclodextrin embedding, enzymatic hydrolysis pH, and embedding temperature on the stability and release of active ingredients (curcumin, triterpenoids from Eriobotrya japonica leaves).

[0044] Description of Experimental Steps Stability Test of Curcumin Materials: Example 1 (embedding molar ratio 1:2), Comparative Example 1 (unembedded), Comparative Example 2 (molar ratio 1:1.2).

[0045] Method: Place the samples in a thermostatic and humidostatic chamber (40°C / 75%RH) and store for 3 months; Take samples monthly and detect the retention rate of curcumin by HPLC (mobile phase: acetonitrile - 0.1% phosphoric acid water = 50:50, flow rate 1.0 mL / min).

[0046] Dissolution Test of Triterpenoids from Eriobotrya japonica Leaves Materials: Example 1 (enzymatic hydrolysis pH 5.0), Comparative Example 3 (enzymatic hydrolysis pH 7.0).

[0047] Method: Use a dissolution tester (paddle method, 50 rpm, medium pH 6.8 phosphate buffer solution, temperature 37°C); Take samples at 10, 30, and 60 minutes and detect the dissolution amount of oleanolic acid by UV method (detection wavelength 210 nm).

[0048] Crystallinity Test of Curcumin Materials: Example 3 (embedding temperature 45°C), Comparative Example 6 (embedding temperature 65°C).

[0049] Method: Take the embedded powder and perform X-ray diffraction (XRD) scanning (2θ range 5° - 40°, step size 0.02°); Analyze the intensity ratio of the characteristic peaks of curcumin (2θ = 17.3°, 23.6°) in the spectrum.

[0050] Experimental Data Table Summary of Key Data in Experimental Example 1: Curcumin Stability: In Example 1, β-cyclodextrin inclusion (molar ratio 1:2) encapsulates curcumin molecules through a hydrophobic cavity, significantly reducing oxidative degradation (retention rate 87.5% vs 62.3% in Comparative Example 1). In Comparative Example 2 with a molar ratio of 1:1.2, incomplete inclusion led to the exposure of free curcumin to the humid heat environment, resulting in a decrease in the retention rate to 71.8%.

[0051] Effect of Enzymatic Hydrolysis pH of Loquat Leaves: The alkaline environment in Comparative Example 3 (pH 7.0) inhibited the activity of cellulase and could not effectively break down the cell wall, with the oleanolic acid dissolution rate only being 54.3% (82.4% in Example 1). This is consistent with the limitation of pH 4.0 - 6.0 in the claims - the acidic environment activates enzyme activity and directionally releases triterpenoid components.

[0052] Inclusion Temperature and Crystallinity: In Comparative Example 6 (inclusion at 65°C), curcumin molecules escaped from the inclusion complex and recrystallized (crystallinity 47.9%), while the amorphous structure in Example 3 (45°C) (crystallinity 8.4%) was more conducive to rapid dissolution in gastrointestinal fluids, verifying the necessity of the temperature range (40 - 60°C) for the stability of the inclusion complex.

[0053] Experimental Example 2: Verification of Physical Properties and Functions of Dosage Forms Experimental Purpose: To verify the correlation between the respiratory targeting, fluidity of atomized dry powder, and the disintegration performance of enteric-coated powder and process parameters.

[0054] Description of Experimental Procedures Measurement of Pulmonary Deposition Rate of Atomized Dry Powder Materials: Example 2 (D90 = 4.8μm), Comparative Example 4 (D90 = 8μm).

[0055] Methods: Use an Andersen impactor (flow rate 60L / min, simulating the human inhalation mode); Load the sample powder, run 5 times, and collect the deposited powder at each stage; Weigh the proportion of inhalable fine particles (≤5μm) (FPF%).

[0056] Measurement of Powder Fluidity Materials: Example 2 (with lactose carrier), Comparative Example 5 (without carrier).

[0057] Methods: Take 50g of powder, fill it into a 100mL graduated cylinder, and measure the bulk density (ρ b ) and tapped density (ρ t ) after free packing; Calculate the Carr index: [(ρ t-ρ b ) / ρ t ×100%。

[0058] Enteric-coated powder disintegration time test Materials: Example 3 (hydroxypropyl methylcellulose coating), Comparative Example 6 (crystallization caused by high-temperature embedding).

[0059] Method: Use a disintegrator (medium: pH 6.8 phosphate buffer solution, temperature 37°C); Record the complete disintegration time of the powder (no residual hard core).

[0060] Experimental data table Table 2 Summary of key data in Experimental Example 2: Respiratory targeting of atomized dry powder: The particle size control of the atomized dry powder in Example 2 (D90 = 4.8 μm) significantly increased the proportion of inhalable particles (63.7%), while in Comparative Example 4 (D90 = 8 μm), due to the too large particle size, the deposition efficiency decreased to 41.2%. This is consistent with the limitation in the claim that the particle size ≤ 5 μm - small particles can penetrate the narrow part of the bronchus and achieve lung-targeted deposition.

[0061] Improvement of the fluidity of the lactose carrier: The Carr index of Comparative Example 5 (without lactose carrier) was as high as 28.6%, indicating that the powder was prone to caking and had poor fluidity; while in Example 2, the lactose carrier (particle size 3 μm) filled the particle gaps, reduced the internal friction (Carr index 13.8%), and ensured the stable dispensing of the dry powder inhaler. The spherical structure of lactose further optimized the powder dispersibility during fluidized bed mixing.

[0062] Embedding temperature and disintegration performance: In Comparative Example 6, due to the too high embedding temperature (65°C), curcumin crystallized (crystallinity detected by XRD was 47.9%), which destroyed the integrity of the hydroxypropyl methylcellulose coating, and the disintegration time was extended to 46.8 minutes (22.5 minutes for Example 3). The crystal growth caused by high temperature formed a physical barrier, hindering the uniform dissolution of the enteric coating, verifying the necessity of the temperature range (40 - 60°C) in the claim for the function of the dosage form.

[0063] Experimental Example 3: Verification of the action threshold of functional ingredients Experimental purpose: To verify the threshold effect of the addition amount of stachyose on the regulation ability of intestinal flora and clarify the necessity of the stachyose content (8 - 12%) in the claim.

[0064] Description of experimental steps In vitro Bifidobacterium proliferation experiment Materials: Example 3 (9% stachyose), Comparative Example 7 (5% stachyose).

[0065] Method: Culture medium preparation: MRS liquid medium, dispensed into 5 groups of parallel samples; Strain inoculation: Inoculate each tube with Bifidobacterium (initial OD600 = 0.1); Cultivation conditions: Anaerobic cultivation at 37°C for 24 hours; Detection index: Record the OD600 absorbance every hour and calculate the proliferation rate.

[0066] Experimental data table Table 3 Summary of key data in Experimental Example 3: In Example 3, the group with a 9% stachyose content showed significant Bifidobacterium proliferation activity (OD600 = 1.52 after 24 hours), while the growth of the flora in Comparative Example 7 (5% stachyose) was significantly limited (OD600 = 0.93). This difference is directly related to the dose-dependence of stachyose as a prebiotic - Bifidobacterium requires a minimum concentration threshold (supported by the literature as 7 - 8%) to activate its transporter system, and low doses cannot trigger an effective metabolic pathway.

[0067] Data volatility (e.g., OD600 = 0.97 in Repeat 2 of Comparative Example 7 vs. 0.88 in Repeat 1) further reflects the sensitivity near the threshold: when the stachyose content is close to but does not reach the critical value, the growth of the flora shows instability. This is consistent with the design logic of the stachyose content range (8 - 12%) in the claims: ensuring the ability to regulate the flora across individual differences.

[0068] In addition, the dose effect of stachyose is closely related to the indirect regulation of respiratory mucosal immunity. Short-chain fatty acids (such as butyric acid) produced by the metabolism of Bifidobacterium can activate immune cells in intestinal lymphoid tissue and enhance the systemic anti-inflammatory response through the "flora-immunity axis". Insufficient flora proliferation in Comparative Example 7 will weaken this linkage mechanism, resulting in the inability of the composition to achieve systemic relief of respiratory symptoms.

[0069] Although the embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions and variations can be made in these embodiments without departing from the principles and spirit of the present invention, and the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A plant synergistic composition for clearing the lungs, moistening dryness, relieving cough and resolving phlegm, characterized in that, Comprising the following components in parts by mass: Loquat leaf powder 10 - 20 parts; Turmeric 5 - 10 parts; Sophora japonica powder 8 - 15 parts; Stachyose 8 - 12 parts; Perilla frutescens powder 5 - 10 parts; Momordica grosvenori powder 8 - 12 parts; Anhydrous glucose 15 - 25 parts.

2. The plant synergistic composition for clearing the lung, moistening dryness, relieving cough and resolving phlegm according to claim 1, wherein The loquat leaf powder is subjected to cellulase hydrolysis treatment, and the hydrolysis conditions include: cellulase activity of 4000 - 6000 U / g, pH 4.0 - 6.0, temperature 40 - 60 °C, and time 1 - 3 hours.

3. The plant synergistic composition for clearing the lung, moistening dryness, relieving cough and resolving phlegm according to claim 1, wherein, The molar ratio of the turmeric to β - cyclodextrin is 1:1.5 - 2.5, and the encapsulation process conditions are: temperature 40 - 60 °C, stirring rate 200 - 500 rpm, and time 1 - 3 hours.

4. A plant synergistic composition for clearing the lungs, moistening dryness, relieving cough and resolving phlegm according to claim 1, wherein The perilla frutescens powder is subjected to lactic acid bacteria fermentation treatment, and the fermentation conditions include: inoculation amount of Lactobacillus plantarum 2 - 5%, temperature 30 - 40 °C, and time 36 - 72 hours.

5. A plant synergistic composition for clearing the lungs, moistening dryness, relieving cough and resolving phlegm according to claim 1, wherein The dosage form of the composition is a multi - layer tablet, including: Outer immediate - release layer: containing loquat leaf powder, momordica grosvenori powder, naringin; Inner sustained - release layer: containing turmeric inclusion complex, sophora japonica powder, carbomer.

6. The plant synergistic composition for moistening the lung, relieving dryness and resolving phlegm and relieving cough according to claim 5, characterized in that The sustained - release layer is coated with hydroxypropyl methylcellulose, and the coating weight gain is 2 - 6%.

7. The plant synergistic composition for clearing the lung, moistening dryness, relieving cough and resolving phlegm according to claim 1, characterized in that, The preparation method of the composition includes the following steps: a) Enzymatic hydrolysis treatment of loquat leaves; b) Fermentation treatment of perilla frutescens powder; c) Composite encapsulation of turmeric and β - cyclodextrin; d) Gradient mixing of each component.

8. The plant synergistic composition for clearing the lung, moistening dryness, relieving cough and resolving phlegm according to claim 7, wherein In step a), after enzymatic hydrolysis, inactivation is carried out at 80 - 90 °C for 10 - 20 minutes. In step c), the inclusion complex is subjected to freeze - drying treatment, with a temperature of - 35 °C to - 50 °C and a vacuum degree of 5 - 20 Pa.

9. Use of a plant synergistic composition for clearing the lung, moistening dryness, relieving cough and resolving phlegm, which is used for a plant synergistic composition for clearing the lung, moistening dryness, relieving cough and resolving phlegm according to claims 1-8, characterized in that, The composition is used for preparing foods, health products or drugs, and is suitable for relieving symptoms such as cough, excessive phlegm, and dry throat.

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