Edible and medicinal dual-purpose traditional Chinese medicine composition for delaying pulmonary fibrosis process as well as preparation method and application of edible and medicinal dual-purpose traditional Chinese medicine composition

Abstract

The invention provides an edible and medicinal dual-purpose traditional Chinese medicine composition for delaying the pulmonary fibrosis process as well as a preparation method and application thereof, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition provided by the invention is prepared from the following raw materials in parts by weight: 1-3 parts of platycodon grandiflorum and 3-8 parts of coix seeds. The food therapy method is used for treating the pulmonary fibrosis, the pulmonary fibrosis can be effectively cured, and the food therapy method is safe and non-toxic. In addition, the traditional Chinese medicine composition has few medicines, is convenient to obtain, has a better curative effect than any single medicine in the composition, and is clear in treatment mechanism. Experiments prove that treatment is carried out from mechanisms of different stages of pulmonary fibrosis, and the effect of staged intervention is achieved.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically a food and medicine combination that can delay the progression of pulmonary fibrosis, its preparation method and application. Background Technology

[0002] Pulmonary fibrosis (PF) is a chronic, progressive, fibrotic interstitial lung disease characterized by excessive extracellular matrix deposition in lung tissue, alveolar structure destruction, and progressive loss of lung function. Clinical manifestations include progressive dyspnea, dry cough, and fatigue; in advanced stages, it often leads to respiratory failure and has a high mortality rate. The etiology of this disease is complex and may be related to multiple factors such as environmental pollution, occupational exposure, viral infection, autoimmune diseases, genetic factors, and drug responses; however, its specific pathogenesis is not yet fully understood.

[0003] Currently, Western medicine has limited treatment options for pulmonary fibrosis, lacking a cure. Commonly used medications include glucocorticoids (such as prednisone acetate), immunosuppressants (such as cyclophosphamide), and antifibrotic drugs (such as pirfenidone and nintedanib). While these drugs can slow disease progression to some extent, they suffer from significant individual variability in efficacy, substantial side effects, and poor safety profiles with long-term use. Furthermore, the clinical application of antioxidants such as N-acetylcysteine ​​is also limited, resulting in unsatisfactory overall treatment outcomes.

[0004] Traditional Chinese medicine (TCM) has a long history and unique advantages in the prevention and treatment of pulmonary fibrosis. TCM often categorizes pulmonary fibrosis under terms like "pulmonary atrophy" and "pulmonary obstruction," believing its pathogenesis mainly involves deficiency of lung qi, phlegm and blood stasis, and obstruction of the lung collaterals. TCM compound formulas, with their multi-component, multi-target, and holistic regulatory characteristics, show great potential in slowing the progression of pulmonary fibrosis and improving patients' quality of life. Existing clinical and experimental studies have shown that some TCM compound formulas exert anti-pulmonary fibrosis effects through mechanisms such as inhibiting inflammatory responses, anti-oxidative stress, regulating immune balance, and inhibiting fibroblast activation and collagen deposition. However, current TCM compound treatments for pulmonary fibrosis still face challenges such as complex formulations, numerous ingredients, inconsistent preparation processes, and unclear mechanisms of action. Furthermore, most formulas primarily focus on drug therapy, with few dual-use (food and drug) options, limiting their daily application and promotion. Therefore, developing a simple, safe, and effective TCM composition that combines dietary and medicinal functions has significant clinical importance and market value. Summary of the Invention

[0005] In view of this, the purpose of the present invention is to provide a Chinese herbal medicine composition that can be used as both food and medicine to delay the progression of pulmonary fibrosis. This Chinese herbal medicine composition has few medicinal ingredients, is easy to obtain, can effectively treat or delay pulmonary fibrosis, and is safe and non-toxic.

[0006] Another objective of this invention is to provide a method for preparing the aforementioned food and medicine dual-use traditional Chinese medicine composition.

[0007] Another objective of this invention is to provide the application of the aforementioned food and medicine composition in the preparation of a drug for treating and delaying the progression of pulmonary fibrosis.

[0008] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a food and medicine combination that can delay the progression of pulmonary fibrosis. The food and medicine combination is prepared from the following raw materials in parts by weight: 1-3 parts of Platycodon grandiflorus and 3-8 parts of Coix lacryma-jobi.

[0009] The present invention also provides a method for preparing the aforementioned food and medicine dual-use traditional Chinese medicine composition, comprising the following steps: Weigh out the platycodon and coix seed by weight, soak them in water; after soaking, add water and bring to a boil over high heat, then simmer over low heat. After simmering, filter to obtain the filtrate; add water again and repeat the above simmering and filtering to obtain the filtrate; combine the two filtrates, concentrate under reduced pressure, and then sterilize under high pressure to obtain a food and medicine combination.

[0010] Preferably, the soaking time is 20-50 minutes.

[0011] Preferably, during decoction, the mass-to-volume ratio of the herbal composition to water is 1g:4-12mL.

[0012] Preferably, the simmering time is 20-30 minutes.

[0013] Preferably, the final concentration of the crude drug after vacuum concentration is 0.5-2 g / mL.

[0014] Preferably, the high-pressure sterilization conditions are constant temperature sterilization at 121℃ for 20-25 minutes.

[0015] The present invention also provides the application of the aforementioned food and medicine dual-use traditional Chinese medicine composition or the food and medicine dual-use traditional Chinese medicine composition obtained by the aforementioned preparation method in the preparation of drugs for treating and delaying the progression of pulmonary fibrosis.

[0016] Preferably, the food and medicine combination can inhibit alveolar epithelial damage and inflammatory response in the early stage of pulmonary fibrosis.

[0017] Preferably, the food and medicine combination can improve the oxidative stress state in the microenvironment of late-stage pulmonary fibrosis.

[0018] Compared with the prior art, the present invention has the following advantages: (1) The food and medicine dual-use traditional Chinese medicine composition provided by this invention consists of only two medicinal and edible raw materials, Platycodon grandiflorus and Coix lacryma-jobi, with a concise formula and widely available and easily accessible raw materials. This composition is both food and medicine, possessing both food safety and therapeutic properties, avoiding the common toxic side effects of chemical drugs, and is highly safe and suitable for long-term use. Experiments have confirmed that the overall efficacy of the Platycodon grandiflorus and Coix lacryma-jobi composition provided by this invention in preventing pulmonary fibrosis is superior to that of either herb alone, indicating a synergistic effect between the two herbs, resulting in a better therapeutic effect. This traditional Chinese medicine composition can both inhibit alveolar epithelial damage and inflammatory response in the early stage of pulmonary fibrosis and improve the oxidative stress state in the microenvironment of late-stage fibrosis, achieving phased and multi-target blockade of the disease process, with a clear therapeutic mechanism.

[0019] (2) The preparation method of the food and medicine dual-use Chinese medicine composition provided by the present invention is conventional water decoction extraction. The process is simple, the conditions are mild, the operation is convenient, the cost is low, and it is easy to standardize and scale up production, which lays a good foundation for the industrial development and clinical application of the product. Attached Figure Description

[0020] Figure 1 This is a technical roadmap for studying the pharmacodynamic effects of the food and drug dual-use traditional Chinese medicine composition of the present invention on rats with pulmonary fibrosis; Figure 2 The figure shows the body weight results of rats in each group in Experiment 1. Compared with the Sham group, P <0.01; compared to the Model group, # P <0.05, ## P <0.01; Figure 3 The figure shows the lung coefficient results for each group of rats in Experiment 1. Compared with the Sham group, P <0.01; compared to the Model group, # P <0.05; Figure 4 The figures show the gross appearance of lung tissue in each group in Experiment 1. In the figure, A is the Sham group, B is the Model group, C is the PFD group, and D is the JY group. Figure 5 The images show HE staining and pathological scoring of lung tissue from rats in each group of Experiment 1 (×100). Figure A shows the HE staining image with a scale bar of 100 μm; Figure B shows the pathological scoring image compared to the Sham group. P <0.01; compared to the Model group, ## P <0.01; compared with the PFD group,& P <0.05; Figure 6 The figures show Masson staining images and pathological scoring images (×100) of lung tissue from rats in each group of Experiment 1. Figure A shows the Masson staining image with a scale bar of 100 μm; Figure B shows the pathological scoring image compared to the Sham group. P <0.01; compared to the Model group, ## P <0.01; Figure 7 The expression of Collagen I protein in the lung tissue of rats in each group of Experiment 1 (×200), scale bar is 50μm; Figure 8 The expression of Fibronectin protein in the lung tissue of rats in each group of Experiment 1 is shown in ×200, with a scale bar of 50 μm. Figure 9 This is a graph showing the hydroxyproline content in the lung tissue of rats in each group of Experiment 1. Compared with the Sham group, the graph shows... P <0.01; compared to the Model group, ## P <0.01; Figure 10 The figure shows the TGF-β1 mRNA expression levels in the lung tissue of rats in each group of Experiment 1. Compared with the Sham group, P <0.01; compared to the Model group, ## P <0.01; Figure 11 The figure shows the expression of TGF-β1 protein in the lung tissue of rats in each group of Experiment 1. Compared with the Sham group, P <0.01; compared to the Model group, ## P <0.01; compared with the PFD group, && P <0.01; Figure 12 The figure shows the results of TGF-β1 intervention in the NR8383 cell fibrosis model using serum containing traditional Chinese medicine in Experiment Example 2, compared with the Control group: P <0.01; compared to the Model+7.5% group: ## P <0.01; Figure 13Figure 3 shows the levels of inflammatory factors in NR8383 cells in each group of Experiment 3. A represents the level of TNF-α inflammatory factor; B represents the level of IL-6 inflammatory factor; and C represents the level of IL-1β inflammatory factor. Compared with the Control group: P <0.01; compared to the Model+7.5% group: # P <0.05, ## P <0.01; Figure 14 The oxidative stress results of NR8383 cells in each group in Experiment 3 are shown in the figure. A represents the level of GSH oxidative stress markers; B represents the level of ROS oxidative stress markers; C represents the level of MDA oxidative stress markers; compared with the control group: P <0.01; compared to the Model+7.5% group: # P <0.05, ## P <0.01. Detailed Implementation

[0021] This invention provides a dual-use Chinese herbal medicine composition for delaying the progression of pulmonary fibrosis. Preferably, the composition is prepared from the following raw materials in parts by weight: 1-3 parts Platycodon grandiflorus and 3-8 parts Coix lacryma-jobi; more preferably, it is prepared from the following raw materials in parts by weight: 1 part Platycodon grandiflorus and 3 parts Coix lacryma-jobi. This invention does not impose any special limitations on the source of the raw materials and they can be conventional commercially available products.

[0022] The present invention also provides a method for preparing the aforementioned food and medicine dual-use traditional Chinese medicine composition, wherein the preparation method preferably includes the following steps: Weigh out the platycodon and coix seed by weight, soak them in water; after soaking, add water and bring to a boil over high heat, then simmer over low heat. After simmering, filter to obtain the filtrate; add water again and repeat the above simmering and filtering to obtain the filtrate; combine the two filtrates, concentrate under reduced pressure, and then sterilize under high pressure to obtain a food and medicine combination.

[0023] In this invention, Platycodon grandiflorus and Coix lacryma-jobi are soaked for 20-50 minutes, then 4-12 times their volume of water are added and brought to a boil over high heat, followed by simmering over low heat for 20-30 minutes. The mixture is then filtered through double-layered sterile gauze. Another 4-12 times their volume of water is added, and the mixture is boiled again for 20-30 minutes (starting from boiling). The two filtrates are combined and concentrated under reduced pressure to a final concentration of 1g crude drug / mL. After autoclaving, the mixture is dispensed and stored at 4°C protected from light for later use. In a preferred embodiment, Platycodon grandiflorus and Coix lacryma-jobi are soaked for 30 minutes, then 8 times their volume of water is added and brought to a boil over high heat, followed by simmering over low heat for 30 minutes. The mixture is then filtered through double-layered sterile gauze. Another 4 times their volume of water is added, and the mixture is boiled again for 20 minutes (starting from boiling). The two filtrates are combined and concentrated under reduced pressure to a final concentration of 1g crude drug / mL. After autoclaving, the mixture is dispensed and stored at 4°C protected from light for later use. In this invention, the final concentration of the concentrated crude drug refers to the final concentration of the Platycodon grandiflorus and Coix lacryma-jobi combination after concentration. The terms "gentle fire" and "vigorous fire" mentioned in this invention are terms from traditional Chinese medicine, and conventional practices in this field can be used.

[0024] In this invention, the high-pressure sterilization conditions are constant temperature sterilization at 121°C for 20-25 minutes, corresponding to a saturated steam pressure of approximately 100-150 kPa.

[0025] The present invention also provides the application of the aforementioned food and medicine dual-use traditional Chinese medicine composition or the food and medicine dual-use traditional Chinese medicine composition obtained by the aforementioned preparation method in the preparation of drugs for treating and delaying the progression of pulmonary fibrosis.

[0026] In this invention, the food and medicine dual-use traditional Chinese medicine composition can inhibit alveolar epithelial damage and inflammatory response in the early stage of pulmonary fibrosis.

[0027] In this invention, the food and medicine dual-use traditional Chinese medicine composition can improve the oxidative stress state in the microenvironment of late-stage pulmonary fibrosis.

[0028] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0029] Unless otherwise specified, the experimental methods used in the following embodiments are conventional methods. Unless otherwise specified, the experimental materials used in the following embodiments are commercially available products.

[0030] Example 1 A food and medicine combination for delaying the progression of pulmonary fibrosis, wherein the raw material ratio of the food and medicine combination is: 10g of Platycodon grandiflorus and 30g of Coix lacryma-jobi.

[0031] The preparation method of the above-mentioned food and medicine dual-use Chinese herbal medicine composition is as follows: After soaking Platycodon grandiflorus and Coix lacryma-jobi for 30 minutes, add 8 times the volume of water and bring to a boil over high heat, then simmer over low heat for 30 minutes and filter through double-layer sterile gauze; add 4 times the volume of water and boil again for 20 minutes (starting from boiling time); combine the two filtrates and concentrate under reduced pressure to a final concentration of 1g crude drug / mL, sterilize under high pressure, dispense into containers, and store at 4℃ protected from light for later use.

[0032] Example 2 A food and medicine combination for delaying the progression of pulmonary fibrosis, wherein the raw material ratio of the food and medicine combination is: Platycodon grandiflorus 30g and Coix lacryma-jobi 40g.

[0033] The preparation method of the above-mentioned food and medicine dual-use Chinese herbal medicine composition is as follows: After soaking Platycodon grandiflorus and Coix lacryma-jobi for 50 minutes, add 12 times the volume of water and bring to a boil over high heat, then simmer over low heat for 30 minutes and filter through double-layer sterile gauze; add 5 times the volume of water and boil again for 25 minutes (starting from boiling time); combine the two filtrates and concentrate under reduced pressure to a final concentration of 2g crude drug / mL, sterilize under high pressure, dispense into containers, and store at 4℃ away from light for later use.

[0034] Example 3 A food and medicine combination for delaying the progression of pulmonary fibrosis, wherein the raw material ratio of the food and medicine combination is: Platycodon grandiflorus 5g and Coix lacryma-jobi 40g.

[0035] The preparation method of the above-mentioned food and medicine dual-use Chinese herbal medicine composition is as follows: After soaking Platycodon grandiflorus and Coix lacryma-jobi for 20 minutes, add 6 times the volume of water and bring to a boil over high heat, then simmer over low heat for 30 minutes and filter through double-layer sterile gauze; add 6 times the volume of water and boil again for 20 minutes (starting from boiling time); combine the two filtrates and concentrate under reduced pressure to a final concentration of 1g crude drug / mL, sterilize under high pressure, dispense into containers, and store at 4℃ protected from light for later use.

[0036] Experimental Example 1: Pharmacodynamic Study of the Traditional Chinese Medicine Composition of the Present Invention on Rats with Pulmonary Fibrosis A bleomycin (BLM)-induced rat phosphatidylcholine (PF) model was used. Experimental animals were divided into a sham-operated group (Sham, saline infusion), a model group (Model, BLM), a positive control group (pirfenidone (BLM), BLM+PFD), and a traditional Chinese medicine intervention group (Platycodon grandiflorus-Coix lacryma-jobi (JY), BLM+JY). After 28 days of continuous administration, the efficacy of this combination was comprehensively evaluated using multiple indicators, including lung coefficient calculation, HE / Masson staining for pathological morphology, ELISA quantification of hydroxyproline, immunofluorescence detection of COL1 and FN expression, and qPCR and Western blotting to detect TGF-β1 mRNA and protein expression levels. Figure 1 This is a technology roadmap.

[0037] 1. Laboratory animals Male Wistar rats (SPF grade, body weight range 170 - 210 g) were purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd., with the animal production license number SYXK (Beijing) 2021 - 0006. The animals were housed in the Animal Breeding Center of Beijing University of Chinese Medicine, with the experimental animal use license number SYXK (Beijing) 2023 - 0011. The feeding environment maintained a temperature of 20°C - 26°C, a daily temperature difference ≤ 4°C, a relative humidity of 40 - 70%, a minimum air change rate of 15 times / h, an air flow velocity ≤ 0.2 m / s at the periphery of the animal cages, a minimum static pressure difference of 10 Pa with the adjacent rooms, an air cleanliness level of 7, a 12 / 12 h day / night light-dark cycle, and a lighting time of 12 h / d (7:00 - 19:00 lighting). During this period, food, water, and bedding were changed in a timely manner to ensure a normal physiological environment for the experimental animals. All rats were formally experimented after 7 days of adaptive feeding, and food and water intake were not restricted during the experiment.

[0038] 2. Experimental methods 2.1 Establishment of a rat model of pulmonary fibrosis Before modeling, the rats were fasted for 12 h without water restriction; after weighing, they were anesthetized by intraperitoneal injection of sodium pentobarbital solution (35 mg / kg, 1% concentration); during the operation, the rats were fixed on the rat board in a supine position, the neck skin of the rats was disinfected, the neck fur was picked up with forceps in the left hand, and a small surgical scissors was used in the right hand to cut a wound about 1 cm long along the neck skin, and the wound muscle was bluntly separated with forceps to expose the trachea; then, a 7 mg / kg BLM solution was evenly dripped into the rat trachea at a rate of 2 mL / h using a micro-infusion pump; after the drug administration was completed, the rat board was kept upright and gently shaken; finally, the skin and muscle at the wound were sutured and disinfected; after the operation, the rats were given an intraperitoneal injection of sodium penicillin solution (80,000 U / d for every 250 g of rats) to prevent infection; the rats were placed in a warm place in the operation room for care and waited for the rats to wake up; In the sham operation group, tracheal instillation was performed using an equal dose of 0.9% normal saline as a control, and the remaining steps were the same as those in the animal model preparation method.

[0039] 2.2 Animal grouping and drug administration Thirty-two male Wistar rats were randomly divided into 4 groups, with 8 rats in each group. They were the sham operation group (Sham), the model group (Model), the positive drug pirfenidone group (PFD), and the traditional Chinese medicine "Platycodon grandiflorum - Coix lacryma-jobi" group (JY). The specific grouping and drug administration are shown in Table 1.

[0040] Table 1 Experimental animal grouping and drug administration

[0041] 2.3 Drug preparation (1) Pirfenidone (PFD) capsules: Prepare a suspension with 0.9% physiological saline. According to the equivalent dose conversion method in "Pharmacological Experimental Methodology" edited by Xu Shuyun (Xu Shuyun, Bian Rulian, Chen Xiu. Pharmacological Experimental Methodology [M]. Beijing: People's Medical Publishing House, 2002), the equivalent dose for rats is about 54 mg / kg, calculated according to the instructions for adults (70kg) 600 mg / d. The dosage is 5.4 mL / kg / d each time. Prepare and use immediately on the day of administration. (2) Platycodon grandiflorus-Coix lacryma-jobi decoction: According to the ratio and preparation method in Example 1, the specific preparation method is as follows: Weigh 10g of Platycodon grandiflorus and 30g of Coix lacryma-jobi, soak for 30min, add 8 times the volume of water and bring to a boil over high heat, then simmer over low heat for 30min, filter through double-layer sterile gauze; add 4 times the volume of water and boil again for 20min (starting from boiling time); combine the two filtrates and concentrate under reduced pressure to a final concentration of 1g crude drug / mL, autoclave and dispense, store at 4℃ protected from light for later use; (3) Based on the clinical dosage (40g / 70kg / d) and referring to the above conversion (Xu Shuyun, Bian Rulian, Chen Xiu. Pharmacological Experimental Methodology [M]. Beijing: People's Medical Publishing House, 2002), rats were given a dose of 3.6g / kg by gavage according to the equivalent dosage.

[0042] 2.4 Sample collection and index testing 2.4.1 General Case Observe the rats' weight changes over 28 days, sensitivity to external stimuli, activity level, respiratory frequency, rhythm, depth and sound, food and water intake, presence of cough, wheezing, abnormal nasal secretions, luster of fur, temperature and color of claws, lips, and excrement characteristics.

[0043] 2.4.2 Sample Collection After the rats in each group were administered the drug by gavage on day 28, they were fasted for 24 hours but allowed to drink water, and then their serum and lung tissue were collected.

[0044] 2.4.3 Paraffin-embedded sections of lung tissue The basic steps are: fixation and post-treatment - dehydration - paraffin embedding - sectioning.

[0045] 2.4.4 Alveolitis Severity Assessment Alveolitis severity was assessed using HE staining. The basic steps were: dewaxing and hydration of paraffin sections, hematoxylin nuclear staining, eosin staining, gradient dehydration and mounting, and microscopic examination and photography. Lung tissue pathological sections from each group of rats were assessed using the Szapiel scoring system. Each indicator was scored from 0 to 3 points according to severity, and the total score was calculated. See Table 2. Table 2 Szapiel scoring system

[0046] 2.4.5 Assessment of the degree of pulmonary fibrosis The degree of pulmonary fibrosis was assessed using the Masson staining method for lung tissue. The steps were as follows: potassium dichromate staining - iron hematoxylin staining - Ponceau S and acid fuchsin staining - phosphomolybdic acid staining - aniline blue staining - differentiation treatment - microscopic examination and photography. The degree of fibrosis in the lung tissue of each group of rats was assessed according to the Ashcroft scoring system, and the scores of each item were accumulated as the total score, as shown in Table 3.

[0047] Table 3 Ashcroft Rating System

[0048] 2.4.6 Determination of Collagen I and Fibronectin levels in lung tissue The levels of Collagen I and Fibronectin in lung tissue were determined using immunofluorescence. The basic steps were: antigen retrieval - serum blocking - primary antibody incubation - secondary antibody incubation - staining with chromogenic agent - dehydration - mounting - microscopic examination and photography.

[0049] 2.4.7 Detection of hydroxyproline levels in lung tissue Accurately weigh an appropriate amount of lung tissue and add physiological saline at a ratio of weight (g):volume (mL) = 1:9. Add magnetic beads and grind the tissue using a tissue homogenizer. Then, centrifuge the lung tissue homogenate (4℃, 3500rpm, 10min), collect the supernatant, and use an ELISA kit to strictly follow the operating instructions to detect the hydroxyproline content in the lung tissue.

[0050] 2.4.8 Detection of TGF-β1 mRNA levels TGF-β1 mRNA levels were detected using qPCR. Primers were designed and synthesized by Beijing Tianyi Huiyuan Biotechnology Co., Ltd. Total RNA was then extracted from mouse lung tissue, reverse transcribed, and amplified by PCR. Detection was performed using... ΔΔ Results of CT scan. Three replicates per group.

[0051] 2.4.9 Western Blot detection of TGF-β1 protein expression level 2.5 Data Processing and Statistical Analysis Statistical analysis and chart creation were performed using GraphPad Prism 9.0 software. Quantitative data were expressed as mean ± standard deviation (mean ± standard deviation). - x±s) represents the independent samples used for between-group comparisons. tFor normally distributed data, use the Mann-Whitney U test (for non-normally distributed data). For comparisons of multiple groups, use one-way ANOVA with appropriate post-hoc tests. The criteria for determining statistical significance are: P <0.05 indicates that the difference is statistically significant. P A value <0.01 is considered statistically significant.

[0052] 3. Treatment efficacy 3.1 General Situation Assessment 3.1.1 General condition of rats in each group During the experiment, the rats in the Sham group were in good physiological condition, reacted quickly, and moved normally. Their food and water intake increased steadily, their breathing was normal, and they did not cough or wheeze. There were no abnormal secretions in their nasal cavity, their fur was shiny, their claws and lips were light pink, and their stool was formed.

[0053] The rats in the Model group had poor mental state, poor sensitivity to external stimuli, significantly reduced activity, poor food and water intake, shallow and rapid breathing, coarse breathing sounds accompanied by rales, nasal discharge, yellowish and withered fur, decreased temperature of the claws on the limbs, and cyanosis of the lips and claws.

[0054] The PFD group rats were slightly less alert and less responsive to external stimuli. Occasionally, they had slightly coarse breathing sounds and rattling sounds. There were no abnormal secretions in their nasal cavity. Their fur was dull, and the color of their claws and lips was lighter. Their temperature was relatively normal, and their stool was occasionally unformed.

[0055] The JY group rats were in better physiological condition, more responsive, and their respiratory frequency, rhythm, depth, and sound were significantly improved compared to the Model group. Their fur was shinier, their claws and lips were lighter in color, their temperature was normal, and their stool was normal.

[0056] 3.1.2 Results of body weight and lung coefficient of rats in each group Rats were weighed one day before modeling (D0), and there was no statistically significant difference in body weight among the groups. P >0.05). Rats were weighed on days 7, 14, 21, and 28. The changes in body weight for each group are shown in Table 4. Figure 2 .

[0057] Compared with the Sham group, the Model group showed a significant decrease in rat body weight at four time points: D7, D14, D21, and D28. P <0.01).

[0058] Compared with the Model group, the body weight of rats in both the PFD group and the JY group increased significantly at all time points. Among them, the body weight gain of the PFD group was statistically different from that of the Model group at day 7.P <0.05, and at the three time points of D14, D21, and D28, the weight gain of rats was significantly different from that of the Model group. P <0.01); In the JY group, the rat body weight increased significantly at four time points: D7, D14, D21, and D28. P <0.05).

[0059] Compared with the PFD group, the body weights of rats in the JY group were similar at the five time points of D0, D7, D14, D21, and D28, with no significant difference. P >0.05), indicating that the JY group was as effective as the positive control drug pirfenidone in improving the general condition of model rats.

[0060] Table 4. Changes in body weight of rats in each group (g, - x ± s )

[0061] Note: Compared to the Sham group P <0.01; compared to the Model group, # P <0.05, ## P <0.01.

[0062] The lung coefficient is a simple method for estimating the degree of pulmonary edema. After 28 days of drug intervention, the lung weight (LW) of the rats was measured, and the lung coefficient was calculated using the following formula: Lung coefficient = Lung wet weight (mg) / Body weight (g) Detailed results are shown in Table 5. Figure 3 Compared to the Sham group, the Model group rats showed increased lung weight due to inflammatory cell infiltration, cell swelling, and capillary congestion, resulting in a significantly increased lung coefficient. P <0.01). Compared with the Model group, the lung coefficients of both the PFD group and the JY group were reduced ( P <0.05. The lung coefficient results of the JY group and the PFD group were comparable, with no significant difference. P >0.05), indicating that the JY group was as effective as the positive control drug pirfenidone in improving pulmonary edema symptoms in model rats.

[0063] Table 5. Lung coefficient results for each group of rats (mg / g, - x ±s)

[0064] Note: Compared to the Sham group P <0.01; compared to the Model group, # P <0.05.

[0065] 3.2 Gross visual observation of lung tissue like Figure 4 The morphological observation results of the lung tissue shown indicate that the lung tissue of the rats in the Sham group has an intact structure, a smooth and normal surface, a light pink color, a soft and elastic texture, and no obvious hemorrhage points or abnormal volume. In the Model group of rats, the lung tissue showed increased surface texture, significantly increased volume with tissue edema, dark red color with congestion-like changes, hardened texture and significantly decreased elasticity, and diffuse punctate hemorrhages and focal ecchymoses were visible. The pathological morphological characteristics of lung tissue in the PFD and JY groups were significantly improved compared with those in the model group. The lung tissue showed a reddish color, partial recovery of softness and elasticity, reduced tissue edema, and a significant reduction in the range of hemorrhage and ecchymosis. This suggests that JY and pirfenidone have significant ameliorative effects on the symptoms of pulmonary hemorrhage and pulmonary edema in the model rats.

[0066] 3.3 Pathological morphology observation and scoring 3.3.1 HE staining observation and scoring HE staining results are as follows Figure 5 As shown in Figure A, the lung tissue structure in the Sham group was normal, with regular alveolar arrangement, uniform septa, and no significant thickening. There was no alveolar fusion or bullae formation, and no significant inflammatory cell infiltration within the alveolar cavities. The Model group showed significant lung tissue structural disorder, manifested as abnormal thickening of alveolar septa, alveolar fusion forming bullae, and localized areas of significant inflammatory cell infiltration. Compared to the Model group, the PFD and JY groups showed significantly improved lung tissue pathological changes, improved alveolar structural integrity, reduced alveolar septal thickening, and a decreased number of inflammatory cells. Pathological quantitative analysis results are as follows: Figure 5 As shown in B, the lung tissue damage score in the Model group was significantly higher than that in the Sham group. P <0.01), the scores of both the PFD group and the JY group were significantly lower than those of the Model group ( P <0.01); the lung tissue injury score in the JY group was higher than that in the PFD group ( P <0.05). This indicates that there is still an inflammatory response in the lung tissue after treatment. The degree of abnormal thickening of alveolar septa and inflammatory symptoms in the lung tissue of both the JY group and the pirfenidone group were improved. Both the JY group and the pirfenidone group can improve lung tissue damage, but the JY group is less effective than the pirfenidone group in improving the degree of lung tissue damage.

[0067] 3.3.2 Masson staining observation and scoring Masson staining results are as follows: Figure 6 As shown in Figure A, the alveolar structure and morphology of the lung tissue in the Sham group were basically normal, with only scattered collagen fibers distributed in the alveolar septa and around blood vessels. The Model group showed significant pathological changes, with extensive areas of consolidation and alveolar structural collapse in the lung tissue. Diffuse abnormal collagen fiber deposition (blue area) was visible in the areas of septal thickening, indicating progression of PF pathology. After intervention, the collagen fiber deposition area in both the PFD and JY groups was significantly reduced compared to the Model group. Lung tissue pathology scores showed ( Figure 6 B), the Model group's score was significantly higher than that of the Sham group ( P <0.01), while the scores of the PFD group and JY group were significantly lower than those of the Model group ( P <0.01); The scores of the PFD group and the JY group were comparable, with no significant difference. P >0.05). This suggests that JY has a similar therapeutic effect to pirfenidone in improving the degree of pulmonary fibrosis in model rats.

[0068] 3.4 Immunofluorescence images and protein quantification results of rat lung tissue in each group The immunofluorescence quantitative results of COL1 and FN in the lung tissue of rats in each group are shown in Table 6. Compared with the Sham group, the expression levels of COL1 and FN proteins in the lung tissue of rats in the Model group were significantly increased ( P <0.01 indicates that pulmonary fibrosis will lead to an increase in the expression levels of COL1 and FN proteins in lung tissue. Compared with the Model group, the expression levels of COL1 and FN proteins in the lung tissue of rats in the PFD and JY groups were significantly decreased. P <0.01); COL1 protein expression was increased and FN protein content was decreased in the lung tissue of rats in the JY group compared with that in the PFD group ( P <0.05)( Figure 7 , Figure 8 The results suggest that both JY and pirfenidone have therapeutic effects on improving COL1 protein expression and FN protein in lung tissue, but the efficacy of the JY group is not as good as that of the pirfenidone group.

[0069] Table 6. Mean optical density values ​​of immunofluorescence in lung tissue of rats in each group ( - x ±s)

[0070] Note: Compared to the Sham group P <0.01; compared to the Model group, ## P <0.01; compared with the PFD group, &P <0.05.

[0071] 3.5 Comparison of hydroxyproline levels in lung tissue of rats in different groups Figure 9 The results showed the hydroxyproline content in rat lung tissue. Hydroxyproline accounts for 13.4% of collagen, and almost all hydroxyproline is found in collagen; it is a collagen-specific amino acid. Therefore, the hydroxyproline content is an important indicator for assessing the degree of PF (Potentially Activated Pepper) and is positively correlated with it. The experimental results showed that the hydroxyproline level in the lung tissue of the Model group rats was significantly higher than that of the Sham group (…). P <0.01); the hydroxyproline levels in the PFD and JY groups were significantly lower than those in the Model group ( P <0.01); The hydroxyproline levels in the PFD group and the JY group were comparable, with no significant difference. P >0.05). This suggests that JY has a similar therapeutic effect to pirfenidone in improving the degree of pulmonary fibrosis in model rats.

[0072] 3.6 Results of TGF-β1 mRNA expression in rats of each group TGF-β1 is a key factor in promoting fibrosis, inducing fibroblast differentiation into myofibroblasts, promoting the aggregation and activation of various inflammatory cells, accelerating the epithelial-mesenchymal transition, and producing matrix components including collagen, laminin, and fibronectin. qPCR results showed ( Figure 10 The expression level of TGF-β1 mRNA in the lung tissue of the Model group was significantly higher than that of the Sham group. P <0.01 indicates that pulmonary fibrosis will lead to an increase in the expression level of TGF-β1 mRNA in lung tissue. After intervention, the TGF-β1 mRNA expression levels in the PFD group and JY group were significantly lower than those in the Model group ( P <0.01); the TGF-β1 mRNA expression levels in the PFD group and the JY group were comparable, with no significant difference. P >0.05). This suggests that JY has similar efficacy to pirfenidone in improving the expression of TGF-β1 mRNA, a key pro-fibrotic factor, in model rats.

[0073] 3.7 Results of TGF-β1 protein expression in rats of each group Figure 11 This study investigated the expression of TGF-β1 protein in rat lung tissue. Western blot analysis showed that TGF-β1 protein expression was significantly upregulated in the Model group. P <0.01); TGF-β1 protein expression was significantly lower in the PFD group and JY group compared to the Model group ( P<0.01). This suggests that both the traditional Chinese medicine composition and pirfenidone have significant therapeutic effects in improving the expression of TGF-β1, a key factor in promoting fibrosis, in model rats.

[0074] Experimental Example 2: A Study on the Differences in the Intervention of the Herbal Composition of the Present Invention in a Rat Alveolar Macrophage Fibrosis Model Using a bleomycin-induced NR8383 cell (rat alveolar macrophage cell line) fibrosis model as the research object, the optimal intervention concentration of the single herb and its combination in this traditional Chinese medicine composition was screened, and the differences in the intervention effects of the single herb and its combination in this traditional Chinese medicine composition on pulmonary fibrosis were studied.

[0075] 1. Experimental Materials 1.1 Cell Source NR8383 cells (CL-0172) were purchased from Wuhan Pronosei Life Science Technology Co., Ltd.

[0076] 1.2 Laboratory Animals Sixty male Wistar rats were housed at the Animal Husbandry Center of Beijing University of Chinese Medicine. The environment was maintained at a temperature of 20℃-26℃, a daily temperature difference of ≤4℃, a relative humidity of 40-70%, a minimum air exchange rate of 15 times / h, an airflow velocity of ≤0.2m / s around the animal cages, a minimum venous pressure difference of 10Pa with connected rooms, an air cleanliness level of 7, a day / night cycle of 12 / 12h, and a lighting time of 12h / d (lighting from 7:00 to 19:00). During this period, food, water, and bedding were changed in a timely manner to ensure the normal physiological environment of the experimental animals.

[0077] 2. Experimental Methods 2.1 Preparation of Traditional Chinese Medicine (1) Decoction of Platycodon grandiflorus alone: ​​After soaking Platycodon grandiflorus (10g) for 30min, add 8 times the volume of water and bring to a boil over high heat, then simmer over low heat for 30min. Filter through double-layer sterile gauze; add 4 times the volume of water and boil again for 20min (starting from boiling time); combine the two filtrates and concentrate under reduced pressure to a final concentration of 1g crude drug / mL, autoclave and dispense into containers, store at 4℃ away from light for later use. (2) Coix seed decoction: After soaking 30g of coix seed for 30min, add 8 times the volume of water and bring to a boil over high heat, then simmer over low heat for 30min. Filter through double-layer sterile gauze; add 4 times the volume of water and boil again for 20min (starting from boiling time); combine the two filtrates and concentrate under reduced pressure to a final concentration of 1g crude drug / mL, autoclave and dispense into containers, store at 4℃ away from light for later use; (3) Decoction of Chinese herbal medicine composition: According to the ratio and preparation method in Example 1, Platycodon grandiflorus (10g) and Coix lacryma-jobi (30g) were soaked for 30min, then 8 times the volume of water were added and boiled over high heat, then simmered over low heat for 30min. The decoction was filtered through double-layer sterile gauze. 4 times the volume of water was added and the decoction was repeated for 20min (starting from boiling). The two filtrates were combined and concentrated under reduced pressure to a final concentration of 1g crude drug / mL. After high pressure sterilization, the decoction was dispensed and stored at 4℃ in the dark for later use. (4) Based on the clinical dosage (40g / 70kg / d) and referring to the above conversion (Xu Shuyun, Bian Rulian, Chen Xiu. Pharmacological Experimental Methodology [M]. Beijing: People's Medical Publishing House, 2002), rats were given a dose of 3.6g / kg by gavage according to the equivalent dosage.

[0078] 2.2 Preparation of serum containing traditional Chinese medicine Sixty rats were randomly divided into four groups using a random number table: blank serum group (Control, n=15), Platycodon grandiflorus-containing serum group (JG, n=15), Coix lacryma-jobi-containing serum group (YYR, n=15), and Platycodon grandiflorus-Coix lacryma-jobi-containing serum group (JY, n=15). The JG, YYR, and JY groups were converted using the equivalent dose coefficient conversion method (based on body surface area) as described in Xu Shuyun's "Pharmacological Experimental Methodology". Using clinically administered doses (10g / 70kg / day, 30g / 70kg / day, and 40g / 70kg / day) as a reference, and after conversion based on the equivalent dose ratio between human and rat body surface area, rats in the JG, YYR, and JY groups were administered doses of 0.9g / kg, 2.7g / kg, and 3.6g / kg, respectively, via gavage. The Control group was administered an equal volume of physiological saline via gavage. Administered once daily for 7 consecutive days. Two hours after the last gavage, rats were anesthetized with 1% sodium pentobarbital solution, and blood was collected from the abdominal aorta. Arterial blood samples were incubated at 4℃ for 2 hours, centrifuged at 3000 rpm for 5 minutes at 4℃, and the supernatant serum was separated. The serum was then inactivated in a 56℃ water bath for 30 minutes, aseptically filtered through a 0.22μm microporous membrane in a clean bench, aliquoted into sterile cryovials, and stored at -20℃ for later use.

[0079] 2.3 ELISA detection of TGF-β1 expression in NR8383 cell fibrosis model using serum containing traditional Chinese medicine. With 1×10 per hole 6Cells were seeded at 100 μL per well in 6-well plates. An equal volume of NR8383 rat alveolar macrophage culture medium (Ham's F-12K (PM150910) + 20% FBS (164210-50) + 1% P / S (PB180120) complete medium) was added to the control wells. BLM solution at a concentration of 100 μg / mL was added to the experimental wells. Cells were incubated at 37°C in a 5% CO2 cell culture incubator. After 24 h of incubation with BLM solution, 7.5% blank serum, 7.5% JG serum, 7.5% YYR serum, and 7.5% JY serum were added, respectively. Samples were collected and analyzed after 24 h of incubation. Specific detection methods were performed according to the kit instructions.

[0080] 2.4 Statistical Analysis Statistical analysis and chart creation were performed using GraphPad Prism 9.0 software. Quantitative data were expressed as mean ± standard deviation (mean ± standard deviation). - x±s) represents the independent samples used for between-group comparisons. t For normally distributed data, use the Mann-Whitney U test (for non-normally distributed data). For comparisons of multiple groups, use one-way ANOVA with appropriate post-hoc tests. The criteria for determining statistical significance are: P <0.05 indicates that the difference is statistically significant. P A value <0.01 is considered statistically significant.

[0081] 3. Experimental Results Effects of Chinese medicine-containing serum on TGF-β1 levels in NR8383 cell fibrosis model To further investigate the effects of single-herb and combined herbal compositions containing serum on the BLM-induced NR8383 cell fibrosis model, the TGF-β1 level in NR8383 cells of each group was measured. The results are shown in Table 7. Figure 12 As shown, the TGF-β1 levels in the Model group and the Model+7.5% group were significantly increased compared to the Control group. P <0.01 indicates that bleomycin may exacerbate pulmonary fibrosis progression by inducing TGF-β1 secretion. The TGF-β1 levels were comparable between the Model+7.5% group and the Model group ( P >0.05); compared with the Model+7.5% group, the TGF-β1 levels in the Model+7.5%JG group, Model+7.5%YYR group, and Model+7.5%JY group were significantly decreased ( PThe <0.01 result indicates that both single herbs and combinations of traditional Chinese medicine compositions have significant efficacy in improving the expression of TGF-β1, a key factor in promoting fibrosis progression, in model rats, and can also significantly reduce the degree of cellular fibrosis in vitro. Regarding the ascending, descending, floating, and sinking properties of the herbs, the JY group (combined with two herbs) showed the greatest decrease, followed by the YYR group (with sinking properties), and finally the JG group (with ascending and floating properties), suggesting that the combination of these herbs is more effective than the single herbs in improving the degree of cellular fibrosis.

[0082] Table 7 Results of TGF-β1 intervention in NR8383 cell fibrosis model using serum containing traditional Chinese medicine (TCM) - x±s)

[0083] Note: Compared to the Control group, P <0.01; compared to the Model+7.5% group: ## P <0.01.

[0084] Experimental Example 3: A differential study of the levels of fibrotic inflammatory factors and oxidative stress in NR8383 cells treated with the herbal composition of this invention. 1. Experimental Materials 1.1 Cell Source NR8383 cells (CL-0172) were purchased from Wuhan Pronosei Life Science Technology Co., Ltd.

[0085] 1.2 Laboratory Animals Sixty male Wistar rats were housed at the Animal Husbandry Center of Beijing University of Chinese Medicine. The environment was maintained at a temperature of 20℃-26℃, a daily temperature difference of ≤4℃, a relative humidity of 40-70%, a minimum air exchange rate of 15 times / h, an airflow velocity of ≤0.2m / s around the animal cages, a minimum venous pressure difference of 10Pa with connected rooms, an air cleanliness level of 7, a day / night cycle of 12 / 12h, and a lighting time of 12h / d (lighting from 7:00 to 19:00). During this period, food, water, and bedding were changed in a timely manner to ensure the normal physiological environment of the experimental animals.

[0086] 2. Experimental Methods 2.1 Preparation of Traditional Chinese Medicine Same as in Experiment 2, Section 2.1.

[0087] 2.2 Preparation of serum containing traditional Chinese medicine Same as in Experiment 2, section 2.2.

[0088] 2.3 ELISA detection of TNF-α, IL-1β, and IL-6 inflammatory factors in cells Follow the instructions for the TNF-α ELISA kit, IL-6 ELISA kit, and IL-1β ELISA kit.

[0089] 2.4 Biochemical methods for detecting cellular GSH, ROS, and MDA levels, markers of oxidative stress. Follow the instructions for the Reduced Glutathione (GSH) Assay Kit, Malondialdehyde (MDA) Assay Kit, and Reactive Oxygen Species (ROS) Assay Kit.

[0090] 2.5 Statistical Analysis Same as in Experiment 2, section 2.4.

[0091] 3. Experimental Results 3.1 Levels of cellular inflammatory factors and oxidative stress in each group The specific results of cellular inflammatory factor levels in each group are shown in Table 8. TNF-α results are as follows: Figure 13 As shown in Figure A, compared with the Control group, the TNF-α levels in the Model group and the Model+7.5% group were significantly increased ( P <0.01. The TNF-α levels in the Model group and the Model+7.5% group were comparable ( P >0.05); compared with the Model+7.5% group, the TNF-α levels in the JG, YYR, and JY groups were significantly decreased; regarding the buoyancy and settling properties of the drugs, the JY group, which combined buoyancy and settling agents, showed the greatest decrease ( P <0.01, followed by the JG group of buoyancy-raising agents ( P <0.01), and finally the sedimentation drug YYR group ( P <0.05).

[0092] IL-6 results as follows Figure 13 As shown in B, compared with the Control group, the IL-6 levels in the Model group and the Model+7.5% group were significantly increased ( P <0.01. The IL-6 levels in the Model group and the Model+7.5% group were comparable ( P >0.05); compared with the Model+7.5% group, the IL-6 levels in the JG group, YYR group, and JY group were significantly lower ( P <0.01); Regarding the properties of buoyancy and sinking agents, the JY group, which combines buoyancy and sinking, showed the largest decrease, followed by the buoyancy-raising agent JG group, and finally the sinking agent YYR group.

[0093] IL-1β results as follows Figure 13 As shown in Figure C, compared with the Control group, the IL-1β levels in the Model group and the Model+7.5% group were significantly higher ( P<0.01. The IL-1β levels in the Model group and the Model+7.5% group were comparable ( P >0.05); compared with the Model+7.5% group, the IL-1β levels in the JG group, YYR group, and JY group were significantly decreased ( P <0.01); Regarding the properties of buoyancy and sinking agents, the JY group, which combines buoyancy and sinking, showed the largest decrease, followed by the buoyancy-raising agent JG group, and finally the sinking agent YYR group.

[0094] Table 8. Results of inflammatory factor levels in NR8383 cells of each group ( - x±s)

[0095] Note: Compared to the Control group: P <0.01; compared to the Model+7.5% group: # P <0.05, ## P <0.01.

[0096] To observe the oxidative stress level of NR8383 cell fibrosis model on serum containing traditional Chinese medicine (Platycodon grandiflorus, Coix lacryma-jobi, and Platycodon grandiflorus-Coix lacryma-jobi), this invention detected the levels of GSH, ROS, and MDA in each group of NR8383 cells. The specific results are shown in Table 9.

[0097] GSH results are as follows Figure 14 As shown in Figure A, compared with the Control group, the GSH levels in the Model group and the Model+7.5% group were significantly lower ( P <0.01. GSH levels were comparable between the Model group and the Model+7.5% group (P>0.05); compared to the Model+7.5% group, GSH levels were significantly higher in all treatment groups (P>0.05). P <0.05); Regarding the ascending and descending properties of the medicine, the JY group, which combines ascending and descending properties, showed the greatest increase ( P <0.01), followed by the sedimentation drug YYR group ( P <0.01), and finally the buoyancy-raising agent group JG ( P <0.05).

[0098] ROS results are as follows Figure 14 As shown in Figure B, compared with the Control group, the ROS fluorescence intensity of the Model group and the Model+7.5% group was significantly increased ( P <0.01. The fluorescence intensity levels of the Model group and the Model+7.5% group were comparable ( P >0.05); compared with the Model+7.5% group, the ROS fluorescence intensity of each treatment group decreased significantly (P <0.01); Regarding the properties of buoyancy and sinking, the JY group with buoyancy and sinking properties decreased the most, followed by the YYR group with sinking properties, and finally the JG group with buoyancy and sinking properties.

[0099] MDA results are as follows Figure 14 As shown in C, compared with the Control group, the MDA levels in the Model group and the Model+7.5% group were significantly higher ( P <0.01. The MDA levels of the Model group and the Model+7.5% group were comparable ( P >0.05); compared with the Model+7.5% group, the MDA levels in all treatment groups were significantly lower ( P <0.01); Regarding the properties of buoyancy and sinking, the JY group with buoyancy and sinking properties decreased the most, followed by the YYR group with sinking properties, and finally the JG group with buoyancy and sinking properties.

[0100] Table 9. Results of oxidative stress in NR8383 cells of each group ( - x±s)

[0101] Note: Compared to the Control group: P <0.01; compared to the Model+7.5% group: # P <0.05, ## P <0.01.

[0102] The results suggest that the ascending drug JG exhibits superior inhibitory effects on inflammatory factors (TNF-α, IL-6, IL-1β), while the settling drug YYR demonstrates more significant effects in clearing oxidative stress markers ROS and MDA, and restoring GSH. Early fibrosis (PF) is primarily characterized by alveolar epithelial damage and inflammatory responses, while late-stage PF is centered on fibroblast activation and ECM deposition. In this experimental case, the significant inhibitory effect of JG on inflammatory factors may be related to its ascending properties. Ascending properties allow the drug to ascend to the lungs and directly act on inflammatory lesions; while the settling properties of YYR, through mechanisms such as strengthening the spleen and eliminating dampness, and scavenging free radicals, may be more beneficial in improving the oxidative stress state in the late-stage fibrotic microenvironment. This finding aligns with the traditional Chinese medicine principle of "adapting medication to the time of the disease," which involves selecting drugs with appropriate properties based on the pathological characteristics of different stages of the disease to optimize efficacy.

[0103] 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 traditional Chinese medicine composition that can be used as both food and medicine to delay the progression of pulmonary fibrosis, characterized in that, The food and medicine dual-use traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 1-3 parts of Platycodon grandiflorus and 3-8 parts of Coix lacryma-jobi.

2. The method for preparing the dual-use Chinese herbal medicine composition according to claim 1, characterized in that, Includes the following steps: Weigh out the platycodon and coix seed by weight, soak them in water; after soaking, add water and bring to a boil over high heat, then simmer over low heat. After simmering, filter to obtain the filtrate; add water again and repeat the above simmering and filtering to obtain the filtrate; combine the two filtrates, concentrate under reduced pressure, and then sterilize under high pressure to obtain a food and medicine combination.

3. The preparation method according to claim 2, characterized in that, The soaking time is 20-50 minutes.

4. The preparation method according to claim 2, characterized in that, When decocting, the mass-to-volume ratio of the herbal composition to water is 1g:4-12mL.

5. The preparation method according to claim 2, characterized in that, The simmering time is 20-30 minutes.

6. The preparation method according to claim 2, characterized in that, The final concentration of the crude drug after vacuum concentration is 0.5-2 g / mL.

7. The preparation method according to claim 2, characterized in that, The autoclaving conditions are 121℃ constant temperature sterilization for 20-25 minutes.

8. The use of the dual-use Chinese medicine composition for food and medicine as described in claim 1 or the dual-use Chinese medicine composition for food and medicine obtained by any one of claims 2-7 in the preparation of a drug for treating and delaying the progression of pulmonary fibrosis.

9. The application according to claim 8, characterized in that, The aforementioned food and medicine combination can inhibit alveolar epithelial damage and inflammatory response in the early stages of pulmonary fibrosis.

10. The application according to claim 8, characterized in that, The food and medicine combination can improve the oxidative stress state in the microenvironment of late-stage pulmonary fibrosis.

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