Traditional Chinese medicine composition for preparing medicine for treating pulmonary fibrosis and preparation method of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for preparing a medicine for treating pulmonary fibrosis and a preparation method thereof, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition for preparing the medicine for treating pulmonary fibrosis is prepared from raw materials through the steps of volatile component extraction, water-soluble component extraction, concentration and preparation, and the raw materials are prepared from, by mass, 20-40 parts of astragalus membranaceus, 20-40 parts of oldenlandia diffusa, 20-40 parts of dandelion, 15-30 parts of trichosanthes kirilowii maxim, 15-30 parts of allium macrostemon, 10-20 parts of polygonum cuspidatum and 15-25 parts of fructus perillae. , 8-16 parts of Ligusticum wallichii, and 4-10 parts of licorice. The composition plays an anti-fibrosis role by regulating immune balance, inhibiting a TGF-beta1 / Smad3 signal channel, improving microcirculation, relieving oxidative stress and the like, achieves a synergistic effect of '1 + 1gt, 2', and has a good clinical application prospect.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine combination for preparing drugs to treat pulmonary fibrosis and its preparation method. Background Technology

[0002] Pulmonary fibrosis is a chronic, progressive disease characterized by interstitial lung inflammation, abnormal proliferation of fibroblasts, and excessive deposition of extracellular matrix, seriously threatening patients' lives and health. Currently, Western medicine treatment mainly relies on anti-fibrotic drugs such as nintedanib and pirfenidone. While these drugs can slow disease progression, they suffer from limited efficacy, numerous adverse reactions, and high costs, making it difficult to meet clinical needs.

[0003] Traditional Chinese medicine (TCM) has shown certain advantages in the treatment of pulmonary fibrosis, classifying the disease as "pulmonary atrophy" or "pulmonary obstruction," with a pathogenesis of deficiency in the root and excess in the branch, with deficiency of lung qi as the root and phlegm and blood stasis obstructing the lungs as the branch. Current TCM treatment regimens often employ methods such as tonifying qi and nourishing yin, promoting blood circulation and removing blood stasis, and clearing heat and detoxifying, achieving certain clinical effects. However, current techniques still have the following problems: First, the proportions of drug combinations are highly arbitrary, making it difficult to guarantee the stability and reproducibility of efficacy; second, the widespread use of traditional decoction methods leads to a significant loss of volatile active ingredients and a low retention rate of key active ingredients, affecting the overall efficacy; third, there is a lack of clear standards and testing methods for the content of active ingredients, resulting in large batch-to-batch quality fluctuations and making standardized production difficult; fourth, the mechanism of action is unclear, limiting its clinical application.

[0004] Therefore, there is an urgent need to develop a scientifically formulated, technologically advanced, quality-controllable, and effective traditional Chinese medicine composition to provide a better solution for the treatment of pulmonary fibrosis. Summary of the Invention

[0005] The first aspect of this invention is to provide a traditional Chinese medicine combination for preparing a drug for treating pulmonary fibrosis, which is obtained by extracting volatile components, extracting water-soluble components, concentrating and formulating raw materials, wherein the raw materials consist of the following raw medicinal materials in parts by weight: Astragalus membranaceus 20-40 parts, Hedyotis diffusa 20-40 parts, Taraxacum mongolicum 20-40 parts, Trichosanthes kirilowii 15-30 parts, Allium macrostemon 15-30 parts, Polygonum cuspidatum 10-20 parts, Perilla frutescens 15-25 parts, Ligusticum chuanxiong 8-16 parts, Glycyrrhiza uralensis 4-10 parts.

[0006] Preferably, in the traditional Chinese medicine combination used to prepare the drug for treating pulmonary fibrosis, the mass ratio of qi-tonifying herbs to heat-clearing and detoxifying herbs is 1:(1.8-2.2), reflecting the principle of "strengthening the body's resistance and eliminating pathogenic factors." The qi-tonifying herbs are Astragalus membranaceus, and the heat-clearing and detoxifying herbs are Hedyotis diffusa and Taraxacum mongolicum. The mass ratio of qi-regulating and phlegm-resolving herbs to blood-activating and stasis-removing herbs is (1.5-2.5):1, highlighting the principle of "treating phlegm and blood stasis simultaneously." The qi-regulating and phlegm-resolving herbs are Trichosanthes kirilowii and Allium macrostemon, and the blood-activating and stasis-removing herbs are Polygonum cuspidatum and Ligusticum chuanxiong. The mass ratio of tonifying herbs to pathogenic herbs in the whole formula is 1:(3-5), ensuring that "eliminating pathogenic factors does not harm the body's resistance." The tonifying herbs are Astragalus membranaceus and Glycyrrhiza uralensis, and the pathogenic herbs are Taraxacum mongolicum, Polygonum cuspidatum, Trichosanthes kirilowii, Allium macrostemon, Perilla frutescens, and Ligusticum chuanxiong.

[0007] Preferably, the raw materials are composed of the following medicinal materials in parts by weight: Astragalus membranaceus 25-35 parts, Hedyotis diffusa 25-35 parts, Taraxacum mongolicum 25-35 parts, Trichosanthes kirilowii 20-28 parts, Allium macrostemon 20-28 parts, Polygonum cuspidatum 12-18 parts, Perilla frutescens 18-22 parts, Ligusticum chuanxiong 10-14 parts, and Glycyrrhiza uralensis 5-8 parts.

[0008] Preferably, the raw materials are composed of the following medicinal materials in parts by weight: 30 parts Astragalus membranaceus, 30 parts Hedyotis diffusa, 30 parts Taraxacum mongolicum, 24 parts Trichosanthes kirilowii, 24 parts Allium macrostemon, 15 parts Polygonum cuspidatum, 20 parts Perilla frutescens, 12 parts Ligusticum chuanxiong, and 6 parts Glycyrrhiza uralensis.

[0009] Preferably, the Astragalus membranaceus contains ≥0.04% astragaloside A and ≥2.0% polysaccharide; the Hedyotis diffusa contains ≥0.05% coumaric acid; the Polygonum cuspidatum contains ≥2.0% polysaccharide and ≥0.3% resveratrol; the Ligusticum chuanxiong contains ≥0.8% volatile oil and ≥0.05% ligustrazine; and the Perilla frutescens contains ≥3.0% volatile oil.

[0010] In the formulation of this invention, the amount and ratio of each raw material must be within the specified range of amount and ratio.

[0011] The second aspect of this invention is to provide a method for preparing the above-mentioned traditional Chinese medicine combination for preparing a drug for treating pulmonary fibrosis, comprising the following steps: S1. Extraction of volatile components: Chuanxiong, Zisuzi, and Xiebai were pulverized and volatile oils were extracted by steam distillation. The volatile oils and residues were collected and encapsulated with β-cyclodextrin to obtain volatile oil inclusion complexes, thereby improving the stability of the volatile oils. S2, Extraction of water-soluble components: Mix Astragalus membranaceus, Hedyotis diffusa, Taraxacum mongolicum, Trichosanthes kirilowii, Polygonum cuspidatum, Glycyrrhiza uralensis and the residue from S1, crush them, soak them in water, bring to a boil over high heat, turn to medium heat for one reflux extraction, and then use medium heat to perform a second reflux extraction on the residue obtained after the first reflux extraction. Combine the two extracts, filter them while hot to obtain the extract. S3. Concentration and Formulation: The extract of S2 is concentrated under reduced pressure, volatile oil is added, and the mixture is stirred evenly. The volatile oil inclusion complex is added, and the mixture is allowed to stand. The mixture is then filtered to remove impurities, yielding a traditional Chinese medicine composition for preparing drugs to treat pulmonary fibrosis.

[0012] Preferably, in step S1, the chuanxiong rhizome, perilla seed, and allium macrostemon are pulverized to 20-40 mesh; the extraction temperature of the steam distillation method is 95℃-105℃, and the extraction time is 2-3 h; the mass ratio of the volatile oil to the β-cyclodextrin is 1:(5-10).

[0013] Preferably, in step S2, the Astragalus membranaceus, Hedyotis diffusa, Taraxacum mongolicum, Trichosanthes kirilowii, Polygonum cuspidatum, Glycyrrhiza uralensis, and the residue extracted in S1 are pulverized to 10-20 mesh; the volume ratio of purified water to raw materials is 1:(8-12), more preferably 1:10; the soaking time is 40-60 min, more preferably 50 min; the first reflux extraction time is 60-90 min, more preferably 75 min; the volume ratio of residue to water is 1:(6-10), more preferably 1:8; the second reflux extraction time is 45-75 min, more preferably 60 min; and the filter screen used for filtration has a mesh size of 100-120.

[0014] Preferably, in step S3, the temperature of the vacuum concentration is 60℃-70℃, the vacuum degree is 0.06-0.09MPa, and the relative density of the concentrated solution is 1.15-1.25; the settling time is 12-24 h.

[0015] Preferably, the traditional Chinese medicine composition can be mixed with pharmaceutically acceptable excipients to form multiple dosage forms, including but not limited to granules, soft capsules, tablets or oral liquids.

[0016] In the traditional Chinese medicine composition of this invention, Astragalus membranaceus, Hedyotis diffusa, and Taraxacum mongolicum synergistically regulate immune balance (Th1 / Th2, Th17 / Treg) and inhibit excessive inflammatory response; Trichosanthes kirilowii and Allium macrostemon synergistically improve pulmonary circulation, reduce microthrombus formation, and provide a material basis for lung tissue repair; Polygonum cuspidatum and Ligusticum chuanxiong synergistically inhibit the TGF-β1 / Smad3 signaling pathway and directly block the fibrosis process; Perilla frutescens regulates lipid metabolism and reduces oxidative stress; and Glycyrrhiza uralensis harmonizes the various herbs, enhancing efficacy and reducing toxicity. Simultaneously, Astragalus polysaccharides and Astragaloside A exert bidirectional immunomodulatory effects, Polygonum cuspidatum glycosides and resveratrol synergistically provide antioxidant and anti-inflammatory effects, Ligustrazine and ferulic acid synergistically improve microcirculation, and volatile oil components promote the absorption of other components and enhance bioavailability.

[0017] Compared with the prior art, the beneficial technical effects of the present invention are as follows: This invention establishes a formulation system combining qi-tonifying herbs with heat-clearing and detoxifying herbs, qi-regulating and phlegm-resolving herbs with blood-activating and stasis-removing herbs, and deficiency-tonifying herbs with pathogen-expelling herbs. This system enables the compositions to exhibit significant advantages in reducing lung coefficient, improving pathological scores, and reducing collagen deposition. Different extraction methods are employed for effective components with different properties, avoiding the significant loss of volatile components caused by traditional decoction and greatly improving the retention rate of volatile oils. The introduction of β-cyclodextrin inclusion technology significantly improves the stability and bioavailability of volatile oils. The content requirements for effective components such as astragaloside A, astragalus polysaccharide, polysaccharide cuspidatum glycoside, resveratrol, ligustrazine, and volatile oils are defined, and batch-to-batch quality stability is ensured through optimized process parameters, laying the foundation for standardized production and clinical promotion.

[0018] The composition of the present invention exerts its anti-fibrotic effect through multiple pathways, such as regulating immune balance, inhibiting the TGF-β1 / Smad3 signaling pathway, improving microcirculation, and reducing oxidative stress, achieving a synergistic effect of "1+1>2" and showing good prospects for clinical application. Attached Figure Description

[0019] The present invention will be further described below with reference to the accompanying drawings.

[0020] Figure 1 HE staining images of lung pathological sections from rats in the blank control group of this invention; Figure 2 HE staining images of lung pathological sections from rats in the model group of this invention; Figure 3 HE staining image of a rat lung pathological section from Example 1 of this invention; Figure 4 This is a Masson staining image of a lung pathological section from a rat in the blank control group of this invention; Figure 5 Masson staining image of lung pathological sections from rats in the model group of this invention; Figure 6 This is a Masson staining image of a rat lung pathological section from Example 1 of the present invention. Detailed Implementation

[0021] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Unless otherwise specified, all experiments were repeated three times, and the results are expressed as mean ± standard deviation.

[0022] Example 1: A traditional Chinese medicine combination for preparing a drug for treating pulmonary fibrosis, comprising the following raw medicinal materials in parts by weight: Astragalus membranaceus 30 parts, Hedyotis diffusa 30 parts, Taraxacum mongolicum 30 parts, Trichosanthes kirilowii 24 parts, Allium macrostemon 24 parts, Polygonum cuspidatum 15 parts, Perilla frutescens 20 parts, Ligusticum chuanxiong 12 parts, Glycyrrhiza uralensis 6 parts Preparation steps: S1. Extraction of volatile oil: Pulverize Ligusticum chuanxiong, Perilla frutescens, and Allium macrostemon to 30 mesh, add 10 times the amount of water, and extract at 100℃ for 2.5 h using steam distillation. S2, Extraction of water-soluble components: Grind Astragalus membranaceus, Hedyotis diffusa, Taraxacum mongolicum, Trichosanthes kirilowii, Polygonum cuspidatum, Glycyrrhiza uralensis, and the residue from S1 to 15 mesh, add 10 times the amount of purified water and soak for 50 min, bring to a boil over high heat and then reflux for 75 min over medium heat; add 8 times the amount of water to the residue and reflux for 60 min over medium heat; combine the extracts and filter while hot (100 mesh). S3. Concentration and inclusion complex: The extract was concentrated at 65℃ and 0.075 MPa under reduced pressure to a relative density of 1.20. The volatile oil inclusion complex (volatile oil: β-cyclodextrin = 1:8) was added, stirred evenly, allowed to stand for 18 h, and filtered to remove impurities, thus obtaining the traditional Chinese medicine combination for preparing drugs to treat pulmonary fibrosis.

[0023] According to the test results, the content of astragaloside A in the traditional Chinese medicine composition obtained in this embodiment is 0.052%, the content of polysaccharide is 2.3%, the content of polysaccharide is 2.4%, the content of resveratrol is 0.38%, the content of ligustrazine is 0.062%, and the volatile oil retention rate is 92%.

[0024] Comparative Example 1 The difference from Example 1 is that it is composed of the following raw medicinal materials in parts by weight: 35 parts of Oldenlandia diffusa, 35 parts of Taraxacum mongolicum, 24 parts of Trichosanthes kirilowii, 24 parts of Allium macrostemon, 15 parts of Polygonum cuspidatum, 20 parts of Perilla frutescens, 12 parts of Ligusticum chuanxiong, and 6 parts of Glycyrrhiza uralensis.

[0025] Preparation process: Same as in Example 1.

[0026] Comparative Example 2 The difference from Example 1 is that it is composed of the following raw medicinal materials in parts by weight: Astragalus membranaceus 15 parts, Hedyotis diffusa 40 parts, Taraxacum mongolicum 40 parts, Trichosanthes kirilowii 30 parts, Allium macrostemon 30 parts, Polygonum cuspidatum 25 parts, Perilla frutescens 25 parts, Ligusticum chuanxiong 20 parts, Glycyrrhiza uralensis 6 parts. Preparation process: Same as in Example 1.

[0027] Comparative Example 3 The difference from Example 1 is that the traditional decoction process is used to prepare the Chinese medicine composition, namely: all medicinal materials are mixed and pulverized to 15 mesh, soaked in 10 times the amount of water for 50 minutes, decocted for 75 minutes, the residue is added to 8 times the amount of water and decocted for another 60 minutes, the decoctions are combined and directly concentrated (no volatile oil is extracted separately, and no β-cyclodextrin inclusion is used).

[0028] Comparative Example 4 The difference from Example 1 is that it is composed of the following raw medicinal materials in parts by weight: Astragalus membranaceus 30 parts, Hedyotis diffusa 30 parts, Taraxacum mongolicum 30 parts, Trichosanthes kirilowii 30 parts, Allium macrostemon 30 parts, Perilla frutescens 25 parts, and Glycyrrhiza uralensis 6 parts (excluding Polygonum cuspidatum and Ligusticum chuanxiong). Preparation process: Same as in Example 1.

[0029] Comparative Example 5 The difference from Example 1 is that it is composed of the following raw medicinal materials in parts by weight: Astragalus membranaceus 100 parts, Hedyotis diffusa 10 parts, Taraxacum mongolicum 10 parts, Trichosanthes kirilowii 10 parts, Allium macrostemon 10 parts, Polygonum cuspidatum 5 parts, Perilla frutescens 5 parts, Ligusticum chuanxiong 5 parts, Glycyrrhiza uralensis 5 parts. Preparation process: Same as in Example 1.

[0030] Test Example 1: Effect Detection 1. Laboratory animals and grouping Animals: SPF-grade male SD rats, weighing 200±20 g, n=10 / group.

[0031] Grouping: Blank group, Model group, Example 1 group, Comparative Examples 1-5 groups 2. Model Establishment Modeling method: Bleomycin (5 mg / kg) was administered via intratracheal drip in a single dose.

[0032] Administration time: Start administering the medication by gavage on the day following model establishment, once a day for 28 consecutive days.

[0033] Dosage: All groups were administered 6 g of crude drug per kg body weight (equivalent to 10 times the human dose).

[0034] 3. Detection indicators 3.1 General Condition Observation Weight changes, skin and fur condition, mental state, degree of cyanosis of the lips; scoring criteria (0-3 points): 0 points is normal, 3 points is severely abnormal.

[0035] 3.2 Lung coefficient Calculation formula: Lung coefficient = Lung wet weight (mg) / Body weight (g) × 100%.

[0036] 3.3 Lung function testing (small animal pulmonary function instrument) Testing indicators: Forced vital capacity (FVC), forced expiratory volume in 0.3 seconds (FEV0.3), and FEV0.3 / FVC ratio.

[0037] 3.4 Histopathology HE staining: to observe alveolar structure, inflammatory cell infiltration, and degree of fibrosis.

[0038] Pathological score (Ashcroft score, 0-8 points).

[0039] Masson staining: quantitative analysis of collagen deposition.

[0040] ImageJ software was used to analyze the percentage of collagen area in indigo staining.

[0041] 3.5 Serum biochemical markers (ELISA) Detection indicators: Hydroxyproline (HYP), Transforming growth factor-β1 (TGF-β1), Tumor necrosis factor-α (TNF-α), Interleukin-6 (IL-6), Interleukin-17 (IL-17).

[0042] 3.6 Lung tissue molecular markers (Western Blot) α-Smooth muscle actin (α-SMA), type I collagen (Collagen I), type III collagen (Collagen III), and Smad3 phosphorylation level (p-Smad3).

[0043] 3.7 Oxidative stress indicators Superoxide dismutase (SOD), malondialdehyde (MDA), and glutathione peroxidase (GSH-Px).

[0044] Table 1 Lung coefficients and pathological scores of rats in each group

[0045] Note: ##P<0.01 vs. blank group; P<0.05, P<0.01 vs. model group; △P<0.05, △△P<0.01 vs. Example 1.

[0046] Table 2 Lung function indicators of rats in each group

[0047] Note: ## indicates P < 0.01 compared to the control group; This indicates that P < 0.05 compared to the model group. △ indicates P < 0.01 compared to the model group; △ indicates P < 0.05 compared to Example 1; △△ indicates P < 0.01 compared to Example 1.

[0048] Table 3. Serum levels of inflammatory factors and fibrosis markers in rats of each group

[0049] Note: ## indicates P < 0.01 compared to the control group; P<0.05, △ indicates P < 0.01 compared to the model group; △ indicates P < 0.05 compared to Example 1; △△ indicates P < 0.01 compared to Example 1.

[0050] Table 4. Expression of fibrosis-related proteins in lung tissues of each group (relative gray values ​​from Western Blot)

[0051] Note: ## indicates P < 0.01 compared to the control group; △△ indicates that P < 0.01 compared to the model group; △△ indicates that P < 0.01 compared to Example 1.

[0052] Table 5 Oxidative stress indices for each group

[0053] Note: ## indicates comparison with the blank group. P <0.01; Indicates comparison with the model group P <0.05, This indicates that P < 0.01 compared to the model group; △ Compared with Example 1 P <0.05, △△ Compared with Example 1 P <0.01.

[0054] Statistical analysis showed that the lung coefficient, pathological score, collagen deposition area, inflammatory factors and fibrosis marker levels in the model group rats were significantly increased, indicating that a pulmonary fibrosis model was successfully established.

[0055] From the perspective of pulmonary function indicators, all indicators of the rats in Example 1 group were close to those of the blank group. This shows that the composition of the present invention can alleviate pathological damage to lung tissue and effectively improve pulmonary ventilation function. The levels of HYP, TGF-β1, and TNF-α in Example 1 group were significantly lower than those in the model group, indicating that the composition of the present invention can effectively inhibit collagen synthesis and inflammatory response. The levels of α-SMA, Collagen I, and the p-Smad3 / Smad3 ratio in the lung tissue of Example 1 group were significantly lower than those in the model group, indicating that the composition of the present invention can inhibit myofibroblast activation and extracellular matrix deposition at the molecular level, thus blocking the fibrosis process.

[0056] In Comparative Example 1, the absence of Astragalus membranaceus resulted in increased lung coefficients in rats, with significantly worse pathological scores, collagen deposition, and serum HYP levels compared to the Example 1 group. The TGF-β1 level in Comparative Example 1 was 58.3% higher than that in Example 1, indicating a significantly weakened immunomodulatory capacity of the formulation, leading to persistent inflammatory responses and difficulty in effectively inhibiting the fibrosis process. Oxidative stress indicators showed that SOD activity and MDA levels in this group were significantly worse than those in Example 1.

[0057] Comparative Example 2 deviated from the "strengthening the body's resistance and eliminating pathogens" formulation, resulting in improvements in lung coefficient, pathological score, and collagen deposition compared to the model group, but still significantly lower than in Example 1. Furthermore, the overall condition of the rats in this group was poor, with some animals exhibiting accelerated weight loss and sallow fur. Although inflammatory factors such as TNF-α and IL-6 decreased significantly in this group, SOD activity was significantly lower than in Example 1, while MDA levels were higher. These data fully demonstrate the necessity of the active pharmaceutical ingredient (API) compatibility principle.

[0058] Comparative Example 3 used a traditional decoction process. Although the drug composition was exactly the same as in Example 1, the volatile oil retention rate was only 65.4%, while that in Example 1 reached 92.3%. The tetramethylpyrazine content was 0.059%, lower than the 0.062% in Example 1. The lung coefficient and collagen deposition in this group were significantly higher than in Example 1, and the serum HYP level was 30.3% higher than in Example 1. Western blot results showed that the α-SMA, Collagen I, and p-Smad3 / Smad3 ratio scores in this group were significantly higher than those in Example 1, indicating a weakened anti-fibrotic efficacy.

[0059] Comparative Example 4 removed the two blood-activating and stasis-removing herbs, Polygonum cuspidatum and Ligusticum chuanxiong. In this group, pulmonary tract and collagen deposition were 22.3% and 39.9% higher, respectively, than in Example 1. Western blot analysis showed that the p-Smad3 / Smad3 ratio in this group was 1.74 times that of Example 1, and Collagen I expression was 65.4% higher. These data indicate that although the absence of blood-activating and stasis-removing herbs can improve some symptoms through regulating qi and resolving phlegm, it cannot effectively block the TGF-β1 / Smad3 fibrosis signaling pathway, leading to continuous fibroblast activation and difficulty in inhibiting collagen synthesis. Serum TGF-β1 levels were 37.1% higher than in Example 1, confirming the crucial role of blood-activating and stasis-removing herbs in inhibiting the fibrosis signaling pathway and promoting extracellular matrix degradation.

[0060] In Comparative Example 5, the dosage of Astragalus membranaceus was as high as 100 parts, while the dosage of other drugs was significantly reduced. Although the total dosage was comparable, this violated the principle of synergistic combination of multiple drugs. Experimental results showed that while the lung coefficient, pathological score, and collagen deposition model group were improved compared to Example 1, the difference was significant. TNF-α levels and IL-6 content were 1.58 times and 1.77 times higher than those in Example 1, respectively, indicating that relying solely on Astragalus membranaceus to replenish Qi is insufficient to effectively control the inflammatory response. Furthermore, some animals in this group exhibited symptoms such as dry mouth and irritability. HPLC analysis showed that although the content of astragaloside A in this preparation was as high as 0.089%, the content of polygaloside was only 0.18% (0.38% in Example 1) and ligustrazine was only 0.028% (0.062% in Example 1), resulting in the loss of synergistic effects across multiple targets, including antioxidant, anti-inflammatory, and microcirculation improvement. This result fully demonstrates the necessity of the "principal, assistant, adjuvant, and guide" theory of traditional Chinese medicine compound prescriptions. Multiple drugs can produce a synergistic effect of "1+1>2" by working together through different targets and mechanisms.

[0061] Example 2 The difference from Example 1 is that it is composed of the following raw medicinal materials in parts by weight: 40 parts of Astragalus membranaceus, 40 parts of Hedyotis diffusa, 40 parts of Taraxacum mongolicum, 30 parts of Trichosanthes kirilowii, 30 parts of Allium macrostemon, 20 parts of Polygonum cuspidatum, 25 parts of Perilla frutescens, 16 parts of Ligusticum chuanxiong, and 10 parts of Glycyrrhiza uralensis. The preparation process parameters were adjusted as follows: volatile oil extraction: 95℃, 3 h; water-soluble components: one reflux extraction for 90 min, two reflux extractions for 75 min; the extract was concentrated under reduced pressure to a relative density of 1.20.

[0062] Example 3 The difference from Example 1 is that it is composed of the following raw medicinal materials in parts by weight: Astragalus membranaceus 20 parts, Hedyotis diffusa 20 parts, Taraxacum mongolicum 20 parts, Trichosanthes kirilowii 15 parts, Allium macrostemon 15 parts, Polygonum cuspidatum 10 parts, Perilla frutescens 15 parts, Ligusticum chuanxiong 8 parts, Glycyrrhiza uralensis 4 parts. The preparation process parameters were adjusted as follows: volatile oil extraction: 105℃, 2 h; water-soluble components: one reflux extraction for 60 min, two reflux extractions for 45 min; the extract was concentrated under reduced pressure to a relative density of 1.15.

[0063] The embodiments described above are merely illustrative of several implementations of the present invention and should not be construed as limiting the scope of the invention. Those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for preparing a drug for treating pulmonary fibrosis, characterized in that, Obtained after volatile component extraction, water-soluble component extraction, concentration and preparation steps from raw materials consisting of the following raw medicinal materials in mass parts: Radix Astragali 20-40 parts, Oldenlandia diffusa 20-40 parts, Taraxacum mongolicum 20-40 parts, Trichosanthes kirilowii 15-30 parts, Allium bakeri 15-30 parts, Polygonum cuspidatum 10-20 parts, Perilla frutescens 15-25 parts, Chuanxiong Rhizoma 8-16 parts, Glycyrrhiza 4-10 parts.

2. The traditional Chinese medicine composition for preparing a drug for treating pulmonary fibrosis according to claim 1, characterized in that, The mass ratio of the qi-tonifying medicinal to the heat-clearing and detoxicating medicinal in the raw materials is 1:(1.8-2.2), the qi-tonifying medicinal is Radix Astragali, and the heat-clearing and detoxicating medicinal is Oldenlandia diffusa and Taraxacum mongolicum; the mass ratio of the qi-regulating and phlegm-resolving medicinal to the blood-activating and stasis-resolving medicinal in the raw materials is (1.5-2.5):1, the qi-regulating and phlegm-resolving medicinal is Trichosanthes kirilowii and Allium bakeri, and the blood-activating and stasis-resolving medicinal is Polygonum cuspidatum and Chuanxiong Rhizoma; the mass ratio of the whole medicinal to the evil-expelling medicinal in the raw materials is 1:(3-5), the whole medicinal is Radix Astragali, Glycyrrhiza, Taraxacum mongolicum, Polygonum cuspidatum, Trichosanthes kirilowii, Allium bakeri, Perilla frutescens and Chuanxiong Rhizoma, and the evil-expelling medicinal is Perilla frutescens and Chuanxiong Rhizoma. 3.The traditional Chinese medicine combination for preparing a medicine for treating pulmonary fibrosis according to claim 1, characterized in that, The raw materials consist of the following raw medicinal materials in mass parts: Radix Astragali 20-40 parts, Oldenlandia diffusa 20-40 parts, Taraxacum mongolicum 20-40 parts, Trichosanthes kirilowii 15-30 parts, Allium bakeri 15-30 parts, Polygonum cuspidatum 10-20 parts, Perilla frutescens 15-25 parts, Chuanxiong Rhizoma 8-16 parts, Glycyrrhiza 4-10 parts.

4. The traditional Chinese medicine composition for preparing a drug for treating pulmonary fibrosis according to claim 1, characterized in that, The raw materials consist of the following raw medicinal materials in mass parts: Radix Astragali 20-40 parts, Oldenlandia diffusa 20-40 parts, Taraxacum mongolicum 20-40 parts, Trichosanthes kirilowii 15-30 parts, Allium bakeri 15-30 parts, Polygonum cuspidatum 10-20 parts, Perilla frutescens 15-25 parts, Chuanxiong Rhizoma 8-16 parts, Glycyrrhiza 4-10 parts.

5. The traditional Chinese medicine composition for preparing a drug for treating pulmonary fibrosis according to claim 1, characterized in that, The content of calycosin in the Radix Astragali is ≥0.04%, and the content of polysaccharide is ≥2.0%; the content of coumaric acid in the Oldenlandia diffusa is ≥0.05%; the content of polydatin in the Polygonum cuspidatum is ≥2.0%, and the content of resveratrol is ≥0.3%; the content of volatile oil in the Chuanxiong Rhizoma is ≥0.8%, and the content of tetramethylpyrazine is ≥0.05%; the content of volatile oil in the Perilla frutescens is ≥3.0%.

6. The traditional Chinese medicine composition for preparing a drug for treating pulmonary fibrosis according to claim 1, characterized in that, The traditional Chinese medicine composition is mixed with pharmaceutically acceptable excipients to prepare granules, soft capsules, tablets or oral liquids.

7. The preparation method of the traditional Chinese medicine combination for preparing the medicine for treating pulmonary fibrosis according to any one of claims 1-6, characterized in that, The steps include: S1, volatile component extraction: crushing Chuanxiong Rhizoma, Perilla frutescens and Allium bakeri, extracting volatile oil by water vapor distillation, collecting volatile oil and dregs, and obtaining volatile oil inclusion complex by β-cyclodextrin inclusion to improve the stability of volatile oil; S2, water-soluble component extraction: mixing Radix Astragali, Oldenlandia diffusa, Taraxacum mongolicum, Trichosanthes kirilowii, Polygonum cuspidatum, Glycyrrhiza and the dregs of S1, crushing, soaking in water, boiling with a large fire after soaking, and then refluxing once with a medium fire, extracting twice with a medium fire, combining the two extraction liquids, filtering while hot, and obtaining an extraction liquid; S3, concentration and preparation: concentrating the extraction liquid of S2 under reduced pressure, adding volatile oil, stirring uniformly, adding volatile oil inclusion complex, standing, filtering impurities, and obtaining a traditional Chinese medicine composition for preparing a drug for treating pulmonary fibrosis.

8. The preparation method according to claim 7, characterized in that, The mass ratio of volatile oil to β-cyclodextrin is 1:(5-10).

9. The preparation method according to claim 7, characterized in that, The time of the first reflux extraction is 60-90 min, and the time of the second reflux extraction is 45-75 min.

10. The preparation method according to claim 7, characterized in that, The relative density of the concentrated liquid obtained after the concentration in the step S3 is 1.15-1.25.

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