Qi tonifying, lung ventilating and phlegm eliminating traditional Chinese medicine composition for treating acute respiratory distress syndrome as well as preparation method and application of qi tonifying, lung ventilating and phlegm eliminating traditional Chinese medicine composition

Abstract

The invention discloses a qi-tonifying, lung-ventilating and phlegm-eliminating traditional Chinese medicine composition for treating acute respiratory distress syndrome. The qi-tonifying, lung-ventilating and phlegm-eliminating traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials: ephedra, astragalus membranaceus, gypsum, roasted rhizoma atractylodis macrocephalae, fructus forsythiae, rhizoma pinellinae praeparata, almond, divaricate saposhnikovia root and liquorice. Chemical components in the traditional Chinese medicine composition of the qi-tonifying, lung-ventilating and phlegm-eliminating decoction are analyzed on the basis of UPLC-Q / TOF-MS, and 233 compounds including 57 flavonoids, 10 phenylpropanoids, 15 unsaturated fatty acid components, 20 triterpenoids, 14 terpene chemical components, 16 alkaloid components, 8 saturated fatty acids, 14 glycosides, 12 tannins, 2 monosaccharide components and 13 steroid components are identified. 13 amino acid components, 4 alkanes, and 35 alkanes in other classes. In addition, an ARDS mouse model induced by LPS and POLY (I: C) mixed nasal dripping is adopted to evaluate the curative effect of the traditional Chinese medicine composition on the ARDS, experimental results show that the qi-tonifying lung-diffusing phlegm-eliminating decoction can remarkably improve pulmonary edema and lung pathological injury of the model mouse, serum biochemical index results show that the qi-tonifying lung-diffusing phlegm-eliminating decoction can reduce inflammatory factors and oxidative stress, and the curative effect of the traditional Chinese medicine composition on the ARDS is improved. The functions of neutrophil are improved, and the traditional Chinese medicine composition has a remarkable effect of treating the acute respiratory distress syndrome.

Description

Technical Field

[0001] The present invention relates to a traditional Chinese medicine composition, and particularly to a traditional Chinese medicine composition for replenishing qi, dispersing lung qi and resolving phlegm for treating acute respiratory distress syndrome, and a preparation method and application thereof. Background Art

[0002] Acute respiratory distress syndrome (ARDS) is like a sudden storm that sweeps through the patient's lungs, plunging them into a state of hypoxia. It is a severe pulmonary inflammatory disease characterized by increased permeability of pulmonary capillaries, resulting in the alveoli being filled with fluid, which hinders oxygen exchange. ARDS is not an independent disease but a clinical syndrome triggered by various direct or indirect lung injury factors. From severe pneumonia to trauma, shock, from inhalation injury to pancreatitis, a variety of inducing factors can act as the fuse for ARDS. Once the disease occurs, patients will rapidly present symptoms such as rapid breathing, cyanosis of the lips, and hypoxemia, and it is difficult to relieve even with high-concentration oxygen. The condition of ARDS progresses rapidly, and the mortality rate remains high, seriously threatening the lives of patients.

[0003] In the face of ARDS, time is of the essence. Early recognition and timely intervention are the keys to improving the prognosis. In recent years, with the continuous in-depth understanding of the pathophysiological mechanism of ARDS and the progress of treatment methods such as mechanical ventilation and extracorporeal membrane oxygenation, the treatment level of ARDS has been significantly improved. However, challenges in treating ARDS still exist, and how to further reduce the mortality rate and improve the long-term prognosis of patients remains an urgent problem to be solved in the medical field. Traditional Chinese medicine has received extensive attention due to its effectiveness in preventing and treating ARDS and its low side effects.

[0004] Although traditional Chinese medicine does not have the disease name of "acute respiratory distress syndrome", according to its clinical manifestations, it can be classified into the categories of "dyspnea syndrome", "pulmonary distension", "sudden dyspnea", "dyspnea with exhaustion", etc. Its etiological factors and pathogenesis include exogenous pathogen invasion, phlegm-heat obstructing the lung, stagnation of lung qi, and qi deficiency and yin injury. Traditional Chinese medicine compound has the characteristics of multi-components, multi-targets, and multi-pathways, and can intervene in the pathological process of ARDS from multiple perspectives. Traditional Chinese medicine treats diseases based on the "holistic concept" and "syndrome differentiation and treatment", pays attention to regulating the overall functional state of the body, can not only improve the symptoms of patients, but also improve the quality of life of patients. And traditional Chinese medicine treatment of ARDS has no obvious adverse reactions, and patients have good compliance. Therefore, traditional Chinese medicine treatment of ARDS has obvious advantages. However, at present, the clinical studies on traditional Chinese medicine treatment of ARDS are mostly small-sample and single-center studies, lacking high-quality evidence-based medicine evidence. And the components of traditional Chinese medicine compound are complex, and its mechanism of action in treating ARDS has not been fully elucidated, and further in-depth studies are needed. The standardized treatment plan for traditional Chinese medicine treatment of ARDS has not been perfected, and further standardization and optimization are needed. In short, traditional Chinese medicine has certain potential in the prevention and treatment of ARDS, but basic research and clinical research still need to be strengthened to provide more safe and effective treatment options for ARDS patients. Summary of the Invention

[0005] Object of the Invention: Through a large number of experiments and combined with clinical medication experience, this invention screens the composition and dosage of traditional Chinese medicine flavors, and uses ultra-high performance liquid chromatography-quadrupole time-of-flight tandem mass spectrometry to identify the chemical components in the traditional Chinese medicine composition for supplementing qi, dispersing the lung qi and resolving phlegm, and clarifies the chemical components of the traditional Chinese medicine composition for supplementing qi, dispersing the lung qi and resolving phlegm. This invention provides evidence support for the traditional Chinese medicine composition for supplementing qi, dispersing the lung qi and resolving phlegm in the treatment of acute respiratory distress syndrome.

[0006] Technical Solution: In order to achieve the above object, the technical solution adopted by this invention is as follows: A traditional Chinese medicine composition for supplementing qi, dispersing the lung qi and resolving phlegm in the treatment of acute respiratory distress syndrome, which is made from the following traditional Chinese medicine raw materials: Ephedra, Astragalus membranaceus, Gypsum fibrosum, Atractylodes macrocephala Koidz. stir-fried, Forsythia suspensa, Pinellia ternata, Armeniaca vulgaris, Saposhnikovia divaricata, Glycyrrhiza uralensis Fisch.

[0007] As a preferred embodiment, the traditional Chinese medicine composition for supplementing qi, dispersing the lung qi and resolving phlegm in the treatment of acute respiratory distress syndrome described above is made from the following traditional Chinese medicine raw materials in parts by weight: Ephedra 12-36 parts, Astragalus membranaceus 24-72 parts, Gypsum fibrosum 60-180 parts, Atractylodes macrocephala Koidz. stir-fried 20-60 parts, Forsythia suspensa 24-72 parts, Pinellia ternata 18-54 parts, Armeniaca vulgaris 20-60 parts, Saposhnikovia divaricata 12-36 parts, Glycyrrhiza uralensis Fisch. 20-60 parts.

[0008] As a preferred embodiment, the traditional Chinese medicine composition for supplementing qi, dispersing the lung qi and resolving phlegm in the treatment of acute respiratory distress syndrome described above is made from the following traditional Chinese medicine raw materials in parts by weight: 12-24 parts of Ephedrae Herba, 24-48 parts of Astragali Radix, 60-120 parts of Gypsum Fibrosum, 20-40 parts of Atractylodis Macrocephalae Rhizoma Praeparatum, 24-48 parts of Forsythiae Fructus, 18-36 parts of Pinelliae Rhizoma Praeparatum, 20-40 parts of Armeniacae Semen Amarum, 12-24 parts of Saposhnikoviae Radix, 20-40 parts of Glycyrrhizae Radix et Rhizoma.

[0009] As a preferred embodiment, the traditional Chinese medicine composition for supplementing qi, dispersing lung qi and resolving phlegm for treating acute respiratory distress syndrome described above is prepared from the following traditional Chinese medicine raw materials in parts by weight: 12 parts of Ephedrae Herba, 24 parts of Astragali Radix, 60 parts of Gypsum Fibrosum, 20 parts of Atractylodis Macrocephalae Rhizoma Praeparatum, 24 parts of Forsythiae Fructus, 18 parts of Pinelliae Rhizoma Praeparatum, 20 parts of Armeniacae Semen Amarum, 12 parts of Saposhnikoviae Radix, 20 parts of Glycyrrhizae Radix et Rhizoma.

[0010] The preparation method of the traditional Chinese medicine composition for supplementing qi, dispersing lung qi and resolving phlegm for treating acute respiratory distress syndrome provided by the present invention comprises the following steps: First, take Ephedrae Herba and Gypsum Fibrosum according to the parts by weight, decoct and extract with water for a period of time, then add Armeniacae Semen Amarum, Glycyrrhizae Radix et Rhizoma, Astragali Radix, Atractylodis Macrocephalae Rhizoma Praeparatum, Saposhnikoviae Radix, Forsythiae Fructus and Pinelliae Rhizoma Praeparatum that have been soaked in water, heat to boil, then decoct with slow fire, filter, combine the filtrates, and concentrate to obtain.

[0011] As a preferred embodiment, the preparation method of the traditional Chinese medicine composition for supplementing qi, dispersing lung qi and resolving phlegm for treating acute respiratory distress syndrome described above comprises the following steps: First, take Ephedrae Herba and Gypsum Fibrosum according to the parts by weight, add 5-10 times the amount of water and decoct and extract for 20-40 min, then add Armeniacae Semen Amarum, Glycyrrhizae Radix et Rhizoma, Astragali Radix, Atractylodis Macrocephalae Rhizoma Praeparatum, Saposhnikoviae Radix, Forsythiae Fructus and Pinelliae Rhizoma Praeparatum that have been soaked in water, add 5-20 times the volume of water based on the weight of the medicinal materials, heat to boil, then decoct with slow fire for 30-120 minutes, filter; add 5-20 times the volume of water to the medicinal residues, heat to boil, then decoct with slow fire for 30-120 minutes, filter, combine the filtrates, and concentrate to obtain.

[0012] As a preferred embodiment, the detection method of the traditional Chinese medicine composition for supplementing qi, dispersing lung qi and resolving phlegm for treating acute respiratory distress syndrome described above comprises the following steps: (1) Preparation of the test solution First, take Ephedrae Herba and Gypsum Fibrosum according to the parts by weight, add 5-10 times the amount of water and decoct and extract for 20-40 min, then add Armeniacae Semen Amarum, Glycyrrhizae Radix et Rhizoma, Astragali Radix, Atractylodis Macrocephalae Rhizoma Praeparatum, Saposhnikoviae Radix, Forsythiae Fructus and Pinelliae Rhizoma Praeparatum that have been soaked in water, add 5-20 times the volume of water based on the weight of the medicinal materials, heat to boil, then decoct with slow fire for 30-120 minutes, filter; add 5-20 times the volume of water to the medicinal residues, heat to boil, then decoct with slow fire for 30-120 minutes, filter, combine the filtrates, concentrate, and filter through a 0.25 μm microporous membrane to prepare the test solution; (2) Take 10 μL of the test sample solution from step (1) and inject it into the UPLC. Under the established UPLC-Q / TOF-MS conditions, analyze the compounds in the traditional Chinese medicine composition for supplementing qi, dispersing lung qi, and resolving phlegm.

[0013] As a preferred embodiment, for the detection method of the traditional Chinese medicine composition for supplementing qi, dispersing lung qi, and resolving phlegm for treating acute respiratory distress syndrome, step (1): The preparation method of the test sample solution is as follows: First, take ephedra and gypsum according to the weight parts. First, add 5 times the amount of water and decoct for 30 minutes, then add bitter apricot seeds, licorice, astragalus membranaceus, stir-fried atractylodes macrocephala, ledebouriella seseloides, forsythia suspensa, and pinellia ternata that have been soaked in water. Add 10 times the volume of water based on the weight of the medicinal materials, bring to a boil over high heat, and then decoct over low heat for 40 minutes, and filter; Take the medicinal residue and continue to add 8 times the volume of water, bring to a boil over high heat, and then decoct over low heat for 30 minutes, filter, combine the filtrates, concentrate, and filter through a 0.25 μm microporous membrane to prepare the test sample solution.

[0014] As a preferred embodiment, for the quality detection method of the cinobufacin capsules described above, the chromatographic conditions in step (2) are as follows: Waters ACQUITY UPLC HSS T3 chromatographic column, specifications 150 mm×2.1 mm, 1.8 μm, volume flow rate 0.3 mL / min, column temperature 35°C, mobile phase is 0.1% formic acid aqueous solution A - acetonitrile B, and the gradient elution process is as follows: Time / min Flow rate / mL / min Mobile phase A% Mobile phase B% 0 0.3 90.0 10.0 2 0.3 90.0 10.0 19 0.3 5.0 95.0 20 0.3 90.0 10.0 21 0.3 90.0 10.0 The mass spectrometry conditions are as follows: Negative ion mode, source conditions: capillary voltage is 2.5 kV, sample cone temperature is 40°C, source temperature is 120°C, desolvation gas temperature is 280°C, cone gas flow rate is 50 L / h, desolvation gas N2, flow rate is 600 L / h; The data acquisition in this mode covers the mass spectrometry range of mass-to-charge ratio 50 - 1200 Da; In the positive ion mode, source conditions: capillary voltage is 3.0 kV, sample cone temperature is 55°C, source temperature is 100°C, desolvation gas temperature is 350°C, cone gas flow rate is 50 L / h, desolvation gas N2 flow rate is 800 L / h; The data acquisition in this mode covers the mass spectrometry range of mass-to-charge ratio 50 - 1200 Da, and the control of data acquisition and analysis is carried out by using Waters MassLynx 4.2 software.

[0015] Beneficial effects: The present invention has the following technical advantages: 1. The present invention screened the composition and dosage of traditional Chinese medicine flavors of Yiqi Xuanfei Huatan Decoction through a large number of experiments and combined with clinical medication experience. The acute respiratory distress syndrome of the type of deficiency of healthy qi and excess of pathogenic factors belongs to the categories of "sudden asthma", "exhaustion of asthma", and "binding chest", and its clinical manifestations include fear of cold, weakness, inability to eat, fatigue, and mild asthma. The traditional Chinese medicine composition of the present invention is composed of 9 medicinal materials including Ephedra, Astragalus membranaceus, Gypsum fibrosum, Atractylodes macrocephala, Forsythia suspensa, Pinellia ternata, Armeniaca vulgaris, Saposhnikovia divaricata, and Glycyrrhiza uralensis, and has the functions of dispersing the lung, replenishing qi, and resolving phlegm.

[0016] 2. The present invention analyzed the chemical components in the traditional Chinese medicine composition of Yiqi Xuanfei Huatan Decoction based on UPLC-Q / TOF-MS, and a total of 233 compounds were identified, including 57 flavonoids, 10 phenylpropanoids, 15 unsaturated fatty acid components, 20 triterpenoid components, 14 terpene chemical components, 16 alkaloid components, 8 saturated fatty acids, 14 glycosides, 12 tannins, 2 monosaccharide components, 13 steroid components, 13 amino acid components, 4 alkanes, and 35 other types.

[0017] 3. The present invention used an ARDS mouse model induced by intranasal instillation of a mixture of LPS and POLY(I:C) to evaluate the efficacy of the traditional Chinese medicine composition in treating ARDS. The experimental results showed that the traditional Chinese medicine composition of Yiqi Xuanfei Huatan Decoction could significantly improve pulmonary edema and pulmonary pathological damage in model mice. The results of serum biochemical indexes showed that Yiqi Xuanfei Huatan Decoction could reduce inflammatory factors and oxidative stress and improve the function of neutrophils, indicating that Yiqi Xuanfei Huatan Decoction has a significant effect in treating acute respiratory distress syndrome. Description of the Drawings

[0018] Figure 1 It is the total ion current chromatogram of the traditional Chinese medicine composition for replenishing qi, dispersing the lung, and resolving phlegm. (A Negative ion mode; B Positive ion mode).

[0019] Figure 2 shows the pathological results of mice treated with ARDS. Representative pathological sections of HE staining of lung tissues in different groups (n = 6). (A) Control; (B) Model; (C) 1 / 4-YQXFHT; (D) 1 / 2-YQXFHT; (E) YQXFHT; (F) 2-YQXFHT; (G) 4-YQXFHT; (H) XBJ.

[0020] Figure 3 It is the effect of YQXFHT on the wet / dry ratio of ARDS mice ( ± SEM, n = 6) Note: ****, p < 0.0001 vs. Control, ***, p < 0.001, **, p < 0.01, , p < 0.001 vs. Model, ##, p < 0.01, #, p < 0.05, n = 6.

[0021] Figure 4 shows the effects of YQXFHT on the levels of IL-6, IL-1β, TNF-α and IL-10 in ARDS mice ( ± SEM, n = 6). ****, p < 0.0001 vs Control, ***, p < 0.001, **, p < 0.01, , p < 0.001 vs Model, ##, p < 0.01, #, p < 0.05, n = 6.

[0022] Figure 5 Effects of YQXFHT on the levels of SOD, GSH and MDA in ARDS mice.

[0023] Note: ****, p < 0.0001 vs. Control, ***, p < 0.001, **, p < 0.01, , p < 0.001 vs. Model, ##, p < 0.01, #, p < 0.05, n = 6.

[0024] Figure 6 shows the effect of YQXFHT on the MPO level in ARDS mice. Note: ****, p < 0.0001 vs. Control, ***, p < 0.001, **, p < 0.01, , p < 0.001 vs. Model, ##, p < 0.01, #, p < 0.05, n = 6. Detailed implementation mode

[0025] The present invention will be further illustrated below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the scope of the present invention. After reading the present invention, various equivalent modifications made by those skilled in the art to the present invention fall within the scope defined by the appended claims of this application.

[0026] Embodiment 1 1. A traditional Chinese medicine composition for supplementing qi, dispersing lung qi and resolving phlegm for treating acute respiratory distress syndrome, which is made from the following traditional Chinese medicine raw materials in parts by weight: Ephedra 12g, Astragalus membranaceus 24g, Gypsum fibrosum 60g, Atractylodes macrocephala Koidz. stir-fried 20g, Forsythia suspensa 24g, Pinellia ternata 18g, Armeniaca vulgaris Lam. 20g, Saposhnikovia divaricata 12g, Licorice 20g.

[0027] 2. First take 12g of ephedra and 60g of gypsum according to the parts by weight. First add 5 times the amount of water and decoct for 30 minutes, then add Armeniaca vulgaris Lam., licorice, Astragalus membranaceus, Atractylodes macrocephala Koidz. stir-fried, Saposhnikovia divaricata, Forsythia suspensa and Pinellia ternata that have been soaked in water. Add 10 times the volume of water based on the weight of the medicinal materials, heat to boiling, and then simmer for 40 minutes, and filter; take the medicinal residues and continue to add 8 times the volume of water, heat to boiling, and then simmer for 30 minutes, filter, combine the filtrates, and concentrate to obtain the product.

[0028] Example 2 1. A traditional Chinese medicine composition for supplementing qi, dispersing lung qi and resolving phlegm to treat acute respiratory distress syndrome, which is made from the following traditional Chinese medicine raw materials in parts by weight: Ephedra 24g, Astragalus membranaceus 48g, Gypsum fibrosum 120g, Atractylodes macrocephala Koidz. stir-fried 40g, Forsythia suspensa 48g, Pinellia ternata 36g, Armeniaca vulgaris Lam. 40g, Saposhnikovia divaricata 24g, Glycyrrhiza uralensis Fisch. 40g.

[0029] 2. First take 24g of Ephedra and 120g of Gypsum fibrosum according to parts by weight. First add 5 times the amount of water and decoct for 40 minutes, then add Armeniaca vulgaris Lam., Glycyrrhiza uralensis Fisch., Astragalus membranaceus, Atractylodes macrocephala Koidz. stir-fried, Saposhnikovia divaricata, Forsythia suspensa and Pinellia ternata that have been soaked in water. Add 12 times the volume of water based on the weight of the medicinal materials. After heating to boiling, decoct with slow fire for 40 minutes and filter; take the medicinal residues and continue to add 10 times the volume of water. After heating to boiling, decoct with slow fire for 30 minutes, filter, combine the filtrates, and concentrate to obtain.

[0030] Example 3 1. A traditional Chinese medicine composition for supplementing qi, dispersing lung qi and resolving phlegm to treat acute respiratory distress syndrome, which is made from the following traditional Chinese medicine raw materials in parts by weight: Ephedra 36g, Astragalus membranaceus 72g, Gypsum fibrosum 180g, Atractylodes macrocephala Koidz. stir-fried 60g, Forsythia suspensa 72g, Pinellia ternata 54g, Armeniaca vulgaris Lam. 60g, Saposhnikovia divaricata 36g, Glycyrrhiza uralensis Fisch. 60g.

[0031] 2. First take 36g of Ephedra and 180g of Gypsum fibrosum according to parts by weight. First add 8 times the amount of water and decoct for 40 minutes, then add Armeniaca vulgaris Lam., Glycyrrhiza uralensis Fisch., Astragalus membranaceus, Atractylodes macrocephala Koidz. stir-fried, Saposhnikovia divaricata, Forsythia suspensa and Pinellia ternata that have been soaked in water. Add 10 times the volume of water based on the weight of the medicinal materials. After heating to boiling, decoct with slow fire for 40 minutes and filter; take the medicinal residues and continue to add 8 times the volume of water. After heating to boiling, decoct with slow fire for 30 minutes, filter; then take the medicinal residues and continue to add 6 times the volume of water. After heating to boiling, decoct with slow fire for 30 minutes, combine the filtrates of the 3 times, and concentrate to obtain.

[0032] Example 4 Qualitative Invention of Chemical Components in YQXFHT Based on UPLC-Q / TOF-MS 1. Experimental Materials 1.1 Drugs and Reagents Acetonitrile (Merck KGaA, Germany, mass spectrometry grade); Formic acid (Merck KGaA, Germany, mass spectrometry grade); Methanol (Honeywell International Inc., chromatographically pure); Ephedra, Armeniaca vulgaris Lam., Gypsum fibrosum, Glycyrrhiza uralensis Fisch., Astragalus membranaceus, Atractylodes macrocephala Koidz., Saposhnikovia divaricata, Forsythia suspensa, Pinellia ternata all come from the pharmacy of Shaanxi University of Chinese Medicine.

[0033] 1.2 Instrument information is as shown in Table 1 below.

[0034] Table 1 Instrument Information Instrument Manufacturer Acquity UPLC system Waters Corporation SYNAPT G2-Si Q-TOF high-resolution time-of-flight mass spectrometer Waters Corporation Waters ACQUITY HSS T3 (2.1 mm × 100 mm, 1.8 μm) Waters Corporation Microfuge 20R benchtop high-speed refrigerated centrifuge Beckman Coulter, Inc., USA Mili-Q IQ7000 ultrapure water system Millipore Corporation, USA 2. Experimental Methods 2.1 Chromatographic Conditions Waters ACQUITY UPLC HSS T3 column (150 mm × 2.1 mm, 1.8 μm), with a flow rate of 0.3 mL / min, column temperature of 35°C, and the mobile phase consisting of 0.1% formic acid aqueous solution (A) - acetonitrile (B). The gradient elution procedure is shown in Table 2.

[0035] Table 2 Gradient Elution Program Time / min Flow rate / mL / min Mobile phase A% Mobile phase B% 0 0.3 90.0 10.0 2 0.3 90.0 10.0 19 0.3 5.0 95.0 20 0.3 90.0 10.0 21 0.3 90.0 10.0 2.2 Mass Spectrometry Conditions Negative ion mode, source conditions: capillary voltage is 2.5 kV, sample cone temperature is 40°C, source temperature is 120°C, desolvation gas temperature is 280°C, cone gas flow rate is 50 L / h, and desolvation gas (N 2 ) flow rate is 600 L / h. The data acquisition in this mode covers the mass spectrometry range of m / z 50 - 1200 Da.

[0036] In positive ion mode, source conditions: capillary voltage is 3.0 kV, sample cone temperature is 55°C, source temperature is 100°C, desolvation gas temperature is 350°C, cone gas flow rate is 50 L / h, and desolvation gas (N 2 ) flow rate is 800 L / h. The data acquisition in this mode covers the mass spectrometry range of m / z 50 - 1200 Da. Data acquisition and analysis control are performed using Waters MassLynx 4.2 software.

[0037] 2.3 Preparation of Test Solution Take the concentrated solution prepared in Example 1, filter it through a 0.25 μm microporous filter membrane to prepare a test solution of Yiqi Xuanfei Huatan Decoction with a mass concentration of 1 g / mL.

[0038] Take the test solution and analyze the compounds in Yiqi Xuanfei Huatan Decoction under UPLC-Q / TOF-MS conditions.

[0039] 3. Experimental Results 3.1 Identification of Chemical Components in Yiqi Xuanfei Huatan Decoction Under the established UPLC-Q / TOF-MS conditions, analyze the compounds in Yiqi Xuanfei Huatan Decoction. As a result, total ion current (BPI) chromatograms (Figure 1) were obtained in both positive ion mode and negative ion mode. By comparing the accurate mass-to-charge ratio with the information in the literature and database, a total of 233 compounds were identified (Tables 3 - 23).

[0040] Table 3 Components of Yiqi Xuanfei Huatan Decoction NO. Component name Formula Neutral mass (Da) Adducts Fragments (m / z) 1 Threonin <![CDATA[C4H9NO3]]> 119.0582 <![CDATA[[M−H] - > 102.0548 2 Lauric acid <![CDATA[C 12 H 24 O2]]> 200.1776 <![CDATA[[M+K] + > 99.0854 3 Gamma aminobutyrIc acid <![CDATA[C4H9NO2]]> 103.06333 <![CDATA[[M−H] - > 71.014059.0142 4 2-Nonanone <![CDATA[C9H 18 O]]> 142.1358 <![CDATA[[M+K] + > 85.06877.06961 5 Tricin <![CDATA[C 17 H 14 O7]]> 330.074 <![CDATA[[M+H] + > 302.0423272.0291 6 eupatilin <![CDATA[C 18 H 16 O7]]> 344.0896 <![CDATA[[M+NH4] + > 302.0423312.0235 7 Pocimene <![CDATA[C 10 H 16 > 136.1252 <![CDATA[[M+Na] + > 81.07359.0715 8 Threitol DL <![CDATA[C4H 10 O4]]> 122.0579 <![CDATA[[M+CH3COO] - > 89.02425.0292 9 Glepidotin A <![CDATA[C 20 H 18 O5]]> 338.1154 <![CDATA[[M+Na] + > 226.0237190.0611 Table 4 Ingredients of Yiqi Xuanfei Huatan Decoction NO. Component name Formula Neutral mass (Da) Adducts Fragments (m / z) 10 Glyasperpine <![CDATA[C 25 H 26 O6]]> 422.1729 <![CDATA[[M+K] + > 226.0237 11 Baicalin <![CDATA[C 21 H 18 O 11 > 446.0849 <![CDATA[[M+Na] + > 294.0374 12 Norlapachol <![CDATA[C 14 H 12 O3]]> 228.0786 <![CDATA[[M+K] + > 155.0089 13 Glabridin <![CDATA[C 20 H 20 O4]]> 324.1362 <![CDATA[[M+H] + > 156.016585.0687 14 Succinic acid <![CDATA[C4H6O4]]> 118.0266 <![CDATA[[M−H] - > 101.0242 16 Pinoresinol (±) <![CDATA[C 20 H 22 O6]]> 358.1416 <![CDATA[[M−H] - > 89.04215.0292 17 8-Hydroxypinoresinol <![CDATA[C 20 H 22 O7]]> 374.1366 <![CDATA[[M−H] - > 89.04215.0293 18 Adoxosidic acid <![CDATA[C 16 H 24 O 10 > 376.1369 <![CDATA[[M+HCOO] - > 333.1175329.0888 19 Uralenol 3-methyl ether <![CDATA[C 21 H 20 O7]]> 384.1209 <![CDATA[[M−H] - > 351.0834135.0441 20 GR <![CDATA[C 10 H 13 O5]]> 283.0916 <![CDATA[[M−H] - > 153.0552 Table 5 Ingredients of Yiqi Xuanfei Huatan Decoction

[0041] Table 6 Ingredients of Yiqi Xuanfei Huatan Decoction

[0042] Table 7 Ingredients of Yiqi Xuanfei Huatan Decoction NO. Component name Formula Neutral mass (Da) Adducts Fragments (m / z) 43 Isoviolanthin <![CDATA[C 27 H 30 O 14 > 578.1636 <![CDATA[[M−H] - > 292.0926 44 Ruti <![CDATA[C 27 H 30 O 16 > 610.1534 <![CDATA[[M−H] - > 311.0941300.0235 45 Forsythiaside <![CDATA[C 29 H 36 O 15 > 624.2054 <![CDATA[[M−H] - > 516.1830487.1452 46 Osthol <![CDATA[C 15 H 16 O3]]> 244.1099 <![CDATA[[M+H] + > 229.1257221.1209 47 Eriodictiol 7-glucoside <![CDATA[C 22 H 24 O 11 > 464.1319 <![CDATA[[M+NH4] + > 303.0828 48 Forsythoside E <![CDATA[C 20 H 30 O 12 > 462.1737 <![CDATA[[M−H] - > 443.1556345.1508 49 vitexin <![CDATA[C 21 H 20 O 10 > 432.1056 <![CDATA[[M+CH3COO] - > 311.0941283.0580 50 Calycosin <![CDATA[C 16 H 12 O5]]> 284.0685 <![CDATA[[M−H] - > 268.0406179.0345 51 Liquiritinapioside <![CDATA[C 26 H 30 O 13 > 550.1686 <![CDATA[[M−H] - > 431.0967433.1010 Table 8 Ingredients of Yiqi Xuanfei Huatan Decoction NO. Component name Formula Neutral mass (Da) Adducts Fragments (m / z) 52 4H-1-Benzopyran-4-one-2,4-beta-D-glucopyranosyloxyphenyl-2,3-dihydro-5,7-dihydroxy-2S <![CDATA[C 21 H 22 O 10 > 434.1213 <![CDATA[[M+Na] + > 182.0978 53 L-Lysin <![CDATA[C7H 16 N4O2]]> 188.1273 <![CDATA[[M+Na] + > 144.1218 54 gondoic acid <![CDATA[C 20 H 38 O2]]> 310.2871 <![CDATA[[M+K] + > 199.1665 55 Matairesinoside <![CDATA[C 26 H 32 O 11 > 520.1945 <![CDATA[[M+K] + > 280.1130283.1328 56 Hirsutrin <![CDATA[C 21 H 20 O 12 > 464.0955 <![CDATA[[M−H] - > 301.0319163.0371 57 mahuannin E <![CDATA[C 30 H 24 O9]]> 528.142 <![CDATA[[M+CH3COO] - > 136.0149 58 Luteolin 7-O-glucuronide <![CDATA[C 21 H 18 O 12 > 462.0798 <![CDATA[[M−H] - > 301.0320163.0371 59 anomalin <![CDATA[C 24 H 26 O7]]> 426.1679 <![CDATA[[M+NH4] + > 237.1138 60 bicuculline (+)- <![CDATA[C 20 H 17 NO6]]> 367.1056 <![CDATA[[M+Na] + > 142.0272 Table 9 Ingredients of Yiqi Xuanfei Huatan Decoction NO. Component name Formula Neutral mass (Da) Adducts Fragments(m / z) 61 Byakangelicin <![CDATA[C 17 H 18 O7]]> 334.1053 <![CDATA[[M+K] + > 273.118989.1001 62 atractylenolideiii <![CDATA[C 15 H 20 O3]]> 248.1412 <![CDATA[[M+Na] + > 193.0903175.1156 63 Glycerol palmitate <![CDATA[C 19 H 38 O4]]> 330.2770 <![CDATA[[M+H] + > 232.1690226.2305 64 Ammidin <![CDATA[C 16 H 14 O4]]> 270.0892 <![CDATA[[M+H] + > 142.0012160.0106 65 Urushiol III <![CDATA[C 21 H 32 O2]]> 316.2402 <![CDATA[[M+H] + > 247.1658275.1968 66 biatractylolide <![CDATA[C 30 H 38 O4]]> 462.277 <![CDATA[[M+Na] + > 177.1298 67 hesperidin <![CDATA[C 28 H 34 O 15 > 610.1898 <![CDATA[[M+H] + > 373.0583 68 astrasieversianin XV <![CDATA[C 46 H 76 O 17 > 900.5083 <![CDATA[[M+H] + > 324.2856334.2856590.2899 69 Docosanoate <![CDATA[C 44 H 86 O4Sr]]> 766.5582 <![CDATA[[M+NH4] + > 226.2314 70 Apigenin <![CDATA[C 15 H 10 O5]]> 270.0528 <![CDATA[[M−H] - > 347.1862 Table 10 Ingredients of Yiqi Xuanfei Huatan Decoction NO. Component name Formula Neutral mass (Da) Adducts Fragments(m / z) 72 Vestitol <![CDATA[C 16 H 16 O4]]> 272.1049 <![CDATA[[M+H] + > 257.1173 73 Pinocembrin <![CDATA[C 15 H 12 O4]]> 256.0736 [M + CH3COO]- 213.0540153.0188 74 isoferulic acid <![CDATA[C 10 H 10 O4]]> 194.0579 [M−H]- 161.0217 75 FERULIC ACID CIS <![CDATA[C 10 H 10 O4]]> 194.0579 <![CDATA[[M−H] - > 161.0217 76 Ononin <![CDATA[C 22 H 22 O9]]> 430.1264 <![CDATA[[M+Na] + > 142.0009128.9932 77 PHILLYRIN <![CDATA[C 27 H 34 O 11 > 534.2101 <![CDATA[[M+HCOO] - > 429.1152 79 Lariciresinol <![CDATA[C 20 H 24 O6]]> 360.1573 <![CDATA[[M+HCOO] - > 329.138 80 liquiritin <![CDATA[C 21 H 22 O9]]> 550.1686 <![CDATA[[M−H] - > 255.0664 81 glycyroside <![CDATA[C 27 H 30 O 13 > 562.1686 <![CDATA[[M+H] + > 473.1061482.1224 82 alpha Amyrenyl acetate Α <![CDATA[C 32 H 52 O2]]> 468.3967 <![CDATA[[M+Na] + > 301.251989.1321 83 1 Methoxyphaseollidin 1 <![CDATA[C 21 H 22 O5]]> 354.1467 <![CDATA[[M+NH4] + > 217.1251203.1464 84 neoliquiritin <![CDATA[C 21 H 22 O9]]> 418.1264 <![CDATA[[M+NH4] + > 332.071 Table 11 Ingredients of Yiqi Xuanfei Huatan Decoction NO. Component name Formula Neutral mass (Da) Adducts Fragments(m / z) 85 Gancaonin G <![CDATA[C 21 H 20 O5]]> 352.1311 <![CDATA[[M+Na] + > 304.0724188.0597 86 formononetin <![CDATA[C 16 H 12 O4]]> 268.0736 [M + K]+ 131.0087114.0058 87 Myristic acid <![CDATA[C 14 H 28 O2]]> 228.2089 <![CDATA[[M+Na] + > 183.1788 88 PTL <![CDATA[C 15 H 20 O3]]> 248.1412 <![CDATA[[M+Na] + > 183.1788 90 Phelloptorin <![CDATA[C 17 H 16 O5]]> 300.0998 <![CDATA[[M+H] + > 217.0893 91 allylmmethylphenylether <![CDATA[C 10 H 12 O]]> 236.1049 <![CDATA[[M+H] + > 193.0902 92 uralsaponin B <![CDATA[C 42 H 62 O 16 > 822.4038 <![CDATA[[M+K] + > 233.2295275.2363 93 Oroxindin <![CDATA[C 22 H 20 O 11 > 460.1006 <![CDATA[[M+K] + > 281.0424283.0628 94 Soyacerebroside ii <![CDATA[C 40 H 75 NO9]]> 713.5441 <![CDATA[[M+K] + > 291.0973 96 Phaseolinisoflavan <![CDATA[C 20 H 20 O4]]> 324.1362 [M + CH3COO]- 295.0983179.1032 96 Glycyram <![CDATA[C 42 H 65 NO 16 > 839.4303 <![CDATA[[M+H] + > 221.1203309.1670 Table 12 Ingredients of Yiqi Xuanfei Huatan Decoction NO. Component name Formula Neutral mass (Da) Adducts Fragments(m / z) 97 Soyasaponin I <![CDATA[C 48 H 78 O 18 > 942.5188 <![CDATA[[M+Na] + > 841.42 98 Jaranol <![CDATA[C 17 H 14 O6]]> 314.079 <![CDATA[[M−H] - > 297.045091.0202 99 Gancaonin I <![CDATA[C 21 H 22 O5]]> 354.1467 <![CDATA[[M+K] + > 193.0902 100 Glepidotin B <![CDATA[C 20 H 20 O5]]> 340.1311 <![CDATA[[M−H] - > 221.0837 101 Isolicoflavonol <![CDATA[C 20 H 18 O6]]> 354.1103 <![CDATA[[M−H] - > 297.0382 102 Glycycoumarin <![CDATA[C 21 H 20 O6]]> 368.126 <![CDATA[[M+H] + > 309.0387281.0408 103 Secoisolariciresinol <![CDATA[C 20 H 26 O6]]> 362.1729 <![CDATA[[M−H] - > 327.1602165.0896 104 Falcarindiol <![CDATA[C 17 H 24 O2]]> 260.1776 <![CDATA[[M+HCOO] - > 220.1461192.1133 105 Licochalcone a <![CDATA[C 21 H 22 O4]]> 338.1518 <![CDATA[[M+NH4] + > 323.1599165.0595 106 hamaudol <![CDATA[C 15 H 16 O5]]> 276.0998 <![CDATA[[M+Na] + > 179.1061 107 Truflex OBP <![CDATA[C 20 H 30 O4]]> 334.2144 <![CDATA[[M−H] - > 149.0238253.0948 Table 13 Ingredients of Yiqi Xuanfei Huatan Decoction NO. Component name Formula Neutral mass (Da) Adducts Fragments(m / z) 108 5 O Methylvisamminol <![CDATA[C 16 H 18 O5]]> 290.1154 <![CDATA[[M+Na] + > 243.0995237.1147 109 Procyanidin <![CDATA[C 30 H 26 O 13 > 594.1373 <![CDATA[[M+NH4] + > 577.1304 110 Medicarpin <![CDATA[C 16 H 14 O4]]> 270.0892 <![CDATA[[M+H] + > 243.0994 111 glabrol <![CDATA[C 20 H 18 O6]]> 392.1988 <![CDATA[[M−H] - > 284.0335267.0642 112 Licochalcone B <![CDATA[C 16 H 14 O5]]> 286.0841 <![CDATA[[M+H] + > 138.0301 113 7 Methoxy 2 methyl <![CDATA[C 17 H 14 O3]]> 266.0943 <![CDATA[[M+H] + > 138.0303 114 Daidzein dimethylether <![CDATA[C 17 H 14 O4]]> 282.0892 <![CDATA[[M+H] + > 269.1154138.0301 115 Sigmoidin B <![CDATA[C 20 H 20 O6]]> 356.126 <![CDATA[[M+HCOO] - > 149.0238 116 Tectochrysin <![CDATA[C 16 H 12 O4]]> 268.0736 <![CDATA[[M+H] + > 254.091 117 pedatisectine f <![CDATA[C9H 14 N2O4]]> 214.0953 <![CDATA[[M+HCOO] - > 125.0232 118 WCO5 cyclohexane WCO5 CyH <![CDATA[C 11 H 12 O5W]]> 408.0194 <![CDATA[[M+HCOO] - > 268.0339 119 RLinalylAcetate(R) <![CDATA[C 12 H 20 O2]]> 196.1463 <![CDATA[[M−H] - > 101.0591 Table 14 Ingredients of Yiqi Xuanfei Huatan Decoction No. Component name Formula Neutral mass (Da) Adducts Fragments (m / z) 120 lCarvylacetateL <![CDATA[C 12 H 18 O2]]> 194.1307 <![CDATA[[M+HCOO] - > 121.0285119.0489 121 Cavidine <![CDATA[C 21 H 23 NO4]]> 353.1627 <![CDATA[[M+H] + > 299.1249 122 Barolub <![CDATA[C 51 H 98 O6]]> 806.7363 <![CDATA[[M+K] + > 494.3571 123 Amide HPL <![CDATA[C 16 H 33 NO]]> 255.2562 <![CDATA[[M+H] + > 239.2397 124 methylpalmitate <![CDATA[C 17 H 34 O2]]> 270.2559 <![CDATA[[M+NH4] + > 197.1941239.1996 125 9Heptadecanol <![CDATA[C 17 H 36 O]]> 256.2766 <![CDATA[[M+H] + > 144.704 126 licoricesaponin G2 <![CDATA[C 42 H 62 O 17 > 838.3987 <![CDATA[[M+H] + > 409.20930415.231 127 Semilicoisoflavone B <![CDATA[C 20 H 16 O6]]> 352.0947 <![CDATA[[M+K] + > 337.1055 128 Glycyrrhizaflavonol A <![CDATA[C 20 H 18 O7]]> 370.1053 <![CDATA[[M−H] - > 351.0854337.1055 129 6shogaol <![CDATA[C 17 H 24 O3]]> 276.1725 <![CDATA[[M−H] - > 91.0202 Table 15 Ingredients of Yiqi Xuanfei Huatan Decoction No. Component name Formula Neutral mass (Da) Adducts Observed RT (min) Fragments (m / z) 130 18betaglycyrrhetinic acid <![CDATA[C 30 H 46 O4]]> 470.3396 <![CDATA[[M+H] + > 13.94 233.2220265.2870 131 Cycloartenol <![CDATA[C 30 H 50 O]]> 426.3861 <![CDATA[[M+NH4] + > 13.97 303.2644 132 Hispaglabridin A <![CDATA[C 25 H 28 O4]]> 392.1988 <![CDATA[[M−H] - > 14.12 161.023 133 Glypallichalcone <![CDATA[C 17 H 16 O4]]> 284.1049 <![CDATA[[[M+CH3COO] - > 14.33 135.0435 134 Stearic acid <![CDATA[C 18 H 36 O2]]> 284.2715 <![CDATA[[M+Na] + > 14.42 209.1947 135 METHYLEUGENOL <![CDATA[C 11 H 14 O2]]> 178.0994 <![CDATA[[M+H] + > 14.49 165.0950 136 11DIETHYL22CARBOCYANINE IODIDE <![CDATA[C 25 H 25 IN2]]> 480.1062 <![CDATA[[M+HCOO] - > 14.6 193.0854 137 L↑iwighteone <![CDATA[C 20 H 18 O5]]> 338.1154 <![CDATA[[M+CH3COO] - > 14.6 229.0862203.0328 138 Glabrone <![CDATA[C 20 H 16 O5]]> 336.0998 <![CDATA[[M+CH3COO] - > 14.99 229.0855 139 7Acetoxy2methylisoflavone <![CDATA[C 18 H 14 O4]]> 294.0892 <![CDATA[[M+H] + > 15 138.0303 140 18betaglycyrrhetinic acid <![CDATA[C 30 H 46 O4]]> 470.3396 <![CDATA[[M−H] - > 15.4 354.2894 Table 16 Ingredients of Yiqi Xuanfei Huatan Decoction No. Component name Formula Neutral mass (Da) Adducts Observed RT (min) Fragments (m / z) 142 oleic acid <![CDATA[C 18 H 34 O2]]> 282.2559 <![CDATA[[M+H] + > 15.62 213.1882235.2080 143 EICOSYLTRICHLOROSILANE <![CDATA[C 20 H 41 Cl3Si]]> 414.2043 <![CDATA[[M+NH4] + > 15.91 173.1742187.1924 144 ASTRAGALOSIDE I <![CDATA[C 45 H 72 O 16 > 840.4507 [M−H]- 16.09 132.0476 145 nonanoic acid <![CDATA[C9H 18 O2]]> 158.1307 <![CDATA[[M−H] - > 16.16 154.061939.0385 146 Euchrenone A10 <![CDATA[C 25 H 26 O5]]> 406.178 <![CDATA[[M−H] - > 16.17 389.1729 147 10hydroxyalphahumulene <![CDATA[C 15 H 24 O]]> 220.1845 <![CDATA[[M+Na] + > 16.18 93.07433124.0857 148 panaxynol <![CDATA[C 17 H 24 O]]> 244.1827 <![CDATA[[M+NH4] + > 16.18 145.106093.0743 150 1H3a7Methanoazulene octahydro1499tetramethyl <![CDATA[C 15 H 26 > 220.1827 <![CDATA[[M+Na] + > 16.18 124.0857145.1060 Table 17 Ingredients of Yiqi Xuanfei Huatan Decoction No. Component name Formula Neutral mass (Da) Adducts Observed RT (min) Fragments (m / z) 151 Palmitic acid <![CDATA[C 16 H 32 O2]]> 256.2402 <![CDATA[[M−H] - > 16.18 213.1846199.1690 152 8Octadecenoic acid <![CDATA[C 10 H 13 N5O]]> 282.2559 <![CDATA[[M−H] - > 16.19 205.1584 153 salidroside <![CDATA[C 14 H 20 O7]]> 300.1209 <![CDATA[[M+Na] + > 16.2 251.0934 154 betaEudesmol <![CDATA[C 15 H 26 O]]> 222.1984 <![CDATA[[M+NH4] + > 16.34 181.1997 155 Arachic acid <![CDATA[C 20 H 40 O2]]> 312.3028 <![CDATA[[M+Na] + > 16.42 279.2661 156 Sitogluside <![CDATA[C 35 H 60 O6]]> 576.4390 <![CDATA[[M+HCOO] - > 16.44 353.1975 157 Octacosanedioic acid <![CDATA[C 28 H 54 O4]]> 454.4022 <![CDATA[[M+NH4] + > 16.45 223.2444 158 heptadecanoic acid 23dihydroxypropyl ester <![CDATA[C 20 H 40 O4]]> 344.2927 <![CDATA[[M+CH3COO] - > 16.52 283.2627 159 hederagenin <![CDATA[C 30 H 48 O4]]> 472.3553 <![CDATA[[M+H] + > 17.07 289.2498327.2293 160 Glyasperin C <![CDATA[C 21 H 24 O5]]> 356.1624 <![CDATA[[M+K] + > 17.14 165.0591 161 arctigenin <![CDATA[C 21 H 24 O6]]> 372.1573 <![CDATA[[M+Na] + > 17.61 345.1706 162 Flavaxin <![CDATA[C 17 H 20 N4O6]]> 376.1383 <![CDATA[[M−H] - > 18.12 213.0748 Table 18 Ingredients of Yiqi Xuanfei Huatan Decoction No. Component name Formula Neutral mass (Da) Adducts Observed RT (min) Fragments (m / z) 163 Astragaloside IV <![CDATA[C 41 H 68 O 14 > 784.4609 [M + CH3COO 18.31 234.1509549.3763 164 Gly <![CDATA[C2H5NO2]]> <![CDATA[[M+H] + > 18.32 413.3489247.2228 165 Farnesol acetate <![CDATA[C 17 H 28 O2]]> 264.2089 <![CDATA[[M+CH3COO] - > 18.6 192.1128 166 Gondoic acid <![CDATA[C 20 H 38 O2]]> 310.2871 <![CDATA[[M+CH3COO] - > 18.73 253.2159 167 Carvacrol methyl ether <![CDATA[C 11 H 16 O]]> 164.1201 <![CDATA[[M−H] - > 18.78 147.0786 168 Zoomaric acid <![CDATA[C 16 H 30 O2]]> 254.2246 <![CDATA[[M−H] - > 18.86 157.1221 169 Pentacosapic acid <![CDATA[C 25 H 50 O2]]> 382.3811 <![CDATA[[M−H] - > 18.87 227.1996157.1221 170 Protopseudohypericin <![CDATA[C 30 H 18 O9]]> 522.0951 <![CDATA[[M+Na] + > 18.87 477.0949 171 PENTADECYLIC ACID <![CDATA[C 15 H 30 O2]]> 242.2246 <![CDATA[[M−H] - > 18.87 157.1221 172 Isopropyl myristate <![CDATA[C 17 H 34 O2]]> 270.2559 <![CDATA[[M−H] - > 18.88 255.2314253.215 173 Linolenic acid <![CDATA[C 18 H 30 O2]]> 278.2246 <![CDATA[[M+HCOO] - > 18.88 221.153 Table 19 Ingredients of Yiqi Xuanfei Huatan Decoction NO. Component name Formula Neutral mass (Da) Adducts Observed RT (min) Fragments (m / z) 174 Glycerol palmitate <![CDATA[C 19 H 38 O4]]> 330.2770 <![CDATA[[M−H] - > 18.89 283.2624269.2473 175 Alexandrin <![CDATA[C 35 H 60 O6]]> 576.4390 <![CDATA[[M+Na] + > 18.93 493.3563328.2679 178 Sitogluside <![CDATA[C 35 H 60 O6]]> 576.4390 <![CDATA[[M+Na] + > 18.93 524.3877493.3563 179 Astragalin <![CDATA[C 21 H 20 O 11 > 448.1006 <![CDATA[[M+HCOO] - > 18.99 434.1205 180 Mandenol <![CDATA[C 20 H 36 O2]]> 308.2715 <![CDATA[[M+NH4] + > 19.24 235.2453 181 Protocatechuic acid <![CDATA[C7H6O4]]> 154.0266 <![CDATA[[M+H] + > 19.41 118.0018 182 Licoricidin <![CDATA[C 26 H 32 O5]]> 424.225 <![CDATA[[M+H] + > 19.48 179.1056205.1256 183 Ursolic acid <![CDATA[C 30 H 48 O3]]> 456.3603 <![CDATA[[M+H] + > 19.54 413.3440412.3364 184 Oleic acid <![CDATA[C 18 H 34 O2]]> 282.2559 <![CDATA[[M+CH3COO] - > 19.55 267.2323 185 Campesterol <![CDATA[C 28 H 48 O]]> 400.3705 <![CDATA[[M+Na] + > 19.63 209.1937 Table 20 Ingredients of Yiqi Xuanfei Huatan Decoction NO. Component name Formula Neutral mass (Da) Adducts Observed RT (min) Fragments (m / z) 186 NHEPTADECANE <![CDATA[C 17 H 36 > 240.2817 <![CDATA[[M+Na] + > 19.8 209.2306 187 Betulonic acid <![CDATA[C 30 H 46 O3]]> 454.3447 <![CDATA[[M+H] + > 19.91 413.3449393.3199 188 Lignoceric acid <![CDATA[C 24 H 48 O2]]> 369.3688 <![CDATA[[M−H] - > 19.93 283.2633 189 LBornyl acetate <![CDATA[C 12 H 20 O2]]> LBornyl acetate <![CDATA[[M−H] - > 19.93 157.1204 190 Neocnidilide <![CDATA[C 12 H 18 O2]]> 194.1307 <![CDATA[[M+HCOO] - > 19.93 121.0284 191 Protocatechualdehyde <![CDATA[C7H6O3]]> 138.0317 <![CDATA[[M−H] - > 19.93 121.0284 192 FORSYTHINOL <![CDATA[C 21 H 24 O6]]> 372.1573 <![CDATA[[M−H] - > 19.94 236.1032132.9906 193 2Zhexadecenoic acid <![CDATA[C 16 H 30 O]]> 254.2246 <![CDATA[[M+Na] + > 19.95 213.1881185.1566 194 PENTADECYLIC ACID <![CDATA[C 15 H 30 O2]]> 242.2246 <![CDATA[[M+Na] + > 19.97 185.1566 195 Arachidic Acid <![CDATA[C 20 H 40 O2]]> 312.302 <![CDATA[[M−H] - > 19.97 283.2624255.2315 Table 21 Ingredients of Yiqi Xuanfei Huatan Decoction NO. Component name Formula Neutral mass (Da) Adducts Observed RT (min) Fragments (m / z) 196 PENTADECYLIC ACID <![CDATA[C 15 H 30 O2]]> 242.2246 <![CDATA[[M+Na] + > 19.97 213.1881 197 Vanillic acid <![CDATA[C8H8O4]]> 168.0423 <![CDATA[[M−H] - > 19.98 121.0284 198 Artonin E <![CDATA[C 25 H 24 O7]]> 436.1522 <![CDATA[[M+NH4] + > 19.99 265.1055285.1104 200 Tricosane C23H48 324.3756 <![CDATA[[M+K] + > 20.01950073 239.2751 201 acetylastragaloside I <![CDATA[C 47 H 74 O 17 > 910.4926 <![CDATA[[M−H] - > 20.02 817.398 202 Tricosane <![CDATA[C 23 H 48 > 324.3756 <![CDATA[[M+K] + > 20.02 239.2751 204 Dibutyl phthalate <![CDATA[C 16 H 22 O4]]> 278.1518 <![CDATA[[M−H] - > 20.03 165.0179 205 phytol <![CDATA[C 20 H 40 O]]> 296.3079 <![CDATA[[M+CH3COO] - > 20.03 205.158 207 olivil <![CDATA[C 20 H 24 O7]]> 376.1522 <![CDATA[[M+Na] + > 20.04 226.0794225.1484 208 sitosterol <![CDATA[C 29 H 50 O]]> 428.4018 <![CDATA[[M+HCOO] - > 20.04 379.1976 209 LUPENONE <![CDATA[C 30 H 48 O]]> 468.3967 <![CDATA[[M+Na] + > 20.05 235.2102233.2220 210 2Nonadecanone <![CDATA[C 19 H 38 O]]> 282.2923 <![CDATA[[M+H] + > 20.05 195.2149239.2751 Table 22 Ingredients of Yiqi Xuanfei Huatan Decoction NO. Component name Formula Neutral mass (Da) Adducts Observed RT (min) Fragments (m / z) 211 19Nonanedione <![CDATA[C9H 16 O2]]> 156.1150 <![CDATA[[M+Na] + > 20.05 85.1034 212 Safrol <![CDATA[C 10 H 10 O2]]> 162.0681 <![CDATA[[M+CH3COO] - > 20.05 121.0285 213 amyrin acetate <![CDATA[C 32 H 52 O2]]> 468.3967 <![CDATA[[M+Na] + > 20.05 249.2234185.1565 214 Docosyl caffeate <![CDATA[C 31 H 52 O4]]> 488.3866 <![CDATA[[M−H] - > 20.05 403.2833367.3570 215 Ethyl palmitate <![CDATA[C 18 H 36 O2]]> 284.2715 <![CDATA[[M−H] - > 20.05 199.1682195.1382 216 Ethyl 2decenoate <![CDATA[C 12 H 22 O2]]> 198.162 <![CDATA[[M+H] + > 20.06 183.1394 218 NNONADECANE <![CDATA[C 19 H 40 > 268.313 <![CDATA[[M+Na] + > 20.06 194.2041195.2149 219 METHYL STEARATE <![CDATA[C 19 H 38 O2]]> 298.2872 <![CDATA[[M+HCOO] - > 20.06 183.1394256.2404 220 3-Methylacetophenone <![CDATA[C9H 10 O]]> 134.0732 <![CDATA[[M+CH3COO] - > 20.06 119.0489 221 Linolenic acid <![CDATA[C 18 H 30 O2]]> 278.2246 <![CDATA[[M−H] - > 20.06 235.1667221.1540 222 Damascenone <![CDATA[C 13 H 18 O]]> 190.1358 <![CDATA[[MCH3COO] - > 20.06 119.0489 Table 23 Ingredients of Yiqi Xuanfei Huatan Decoction NO. Component name Formula Neutral mass (Da) Adducts Observed RT (min) Fragments (m / z) 223 Anethole <![CDATA[C 10 H 12 O]]> 148.0888 <![CDATA[[M+CH3COO] - > 20.06 119.0489 224 Neral <![CDATA[C 10 H 16 O]]> 152.1201 <![CDATA[[M+CH3COO] - > 20.06 119.0489 225 N-NONADECANE <![CDATA[C 19 H 40 > 268.3130 <![CDATA[[M+Na] + > 20.06 239.2751 226 Supraene <![CDATA[C 30 H 50 > 410.3913 <![CDATA[[M+Na] + > 20.07 275.2718326.2978 227 Ethyl palmitelaidate <![CDATA[C 18 H 34 O2]]> 282.2559 <![CDATA[[M−H] - > 20.07 205.1580207.1404 228 14-Eicosadiene <![CDATA[C 20 H 38 > 464.1319 <![CDATA[[M+NH4] + > 20.08 233.2220234.2360263.2732 230 Glabrolide <![CDATA[C 30 H 44 O4]]> 468.3240 <![CDATA[[M+Na] + > 20.08 370.3258281.1904 231 Lauric anhydride <![CDATA[C 24 H 46 O3]]> 382.3447 <![CDATA[[M+H] + > 20.09 140.1558183.139 232 Arabinose D <![CDATA[C5H 10 O5]]> 150.0528 <![CDATA[[M+Na] + > 20.17 92.0458 233 3,4-Dihydroxybenzoic acid <![CDATA[C7H6O4]]> 154.0266 <![CDATA[[M+H] + > 20.37 138.0300110.0315 In this invention, UPLC-Q / TOF-MS was used to analyze the chemical components in Tianma Xuanyunning Mixture, and a total of 233 compounds were identified, including 57 flavonoids, 10 phenylpropanoids, 15 unsaturated fatty acid components, 20 triterpenoid components, 14 terpenoid chemical components, 16 alkaloid components, 8 saturated fatty acids, 14 glycosides, 12 tannins, 2 monosaccharide components, 13 steroid components, 13 amino acid components, 4 alkanes, and 35 other components. This reflects the diversity of the chemical component categories in Yiqi Xuanfei Huatan Decoction (YQXFHT), which is of great significance for identifying and controlling the quality of Yiqi Xuanfei Huatan.

[0043] Effect Evaluation of Yiqi Xuanfei Huatan Decoction in Treating Mice with Acute Respiratory Distress Syndrome in Example 5 1. Experimental Materials 1.1 Experimental Animals 64 SPF-grade male BALB / C mice, weighing (20 ± 2) g, were purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd., with the certificate number and license number: SCXK (Jing) 2021-0006. The animals were placed in a pathogen-free room with a regulated temperature, lighting system, and a 12 h light / dark cycle. All experimental procedures were approved by the Animal Care and Use Committee of Shaanxi University of Chinese Medicine, with the ethical review number SUCMDL20230826001. The animal feeding and experimental operations complied with the requirements of the experimental management regulations.

[0044] 1.2 Reagents and Drugs Yiqi Xuanfei Huatan Decoction YQXFHT (Ephedra sinica, Armeniaca vulgaris, Gypsum fibrosum, Glycyrrhiza uralensis, Astragalus membranaceus, Atractylodes macrocephala, Saposhnikovia divaricata, Forsythia suspensa, Pinellia ternata) (Shaanxi University of Chinese Medicine), Xuebijing Injection (China Hongri), LPS (Merck, Germany), POLY I:C (Merck, Germany). IL-1β ELISA Kit (Catalog No.: ml003057, Lot No. E20231011-30206B), TNF-α ELISA Kit (Catalog No.: ml002859, Lot No. E20231011-30206B), IL-6 ELISA Kit (Catalog No.: ml102828, Lot No. E20231011-31063B), IL-10 ELISA Kit (Catalog No.: ml102828, Lot No. E20231011-31063B), SOD ELISA Kit (Catalog No.: ml102828, Lot No. E20231011-31063B), GSH ELISA Kit (Catalog No.: ml102828, Lot No. E20231011-3f063B); MDA ELISA Kit (Catalog No.: ml102828, Lot No. E20231011-31063B), MPO ELISA Kit (Catalog No.: ml102828, Lot No. E20231011-31063B) were all purchased from Nanjing Jiancheng Bioengineering and Invention Institute.

[0045] 1.3 Instrument and Equipment Table 24 Instrument Information Instruments and Reagents Manufacturer RE-52AA Rotary Evaporator Shanghai Yarong Biochemical Instrument Factory KQ-500DE CNC Ultrasonic Cleaner Kunshan Ultrasonic Instruments Co., Ltd. Multifunctional Microplate Reader American Gene Biotechnology Co., Ltd. Centrifuge 5418R Bench Centrifuge Eppendorf AG, Germany Thermomixer Eppendorf AG, Germany Donatello Tissue Processor DIAPATH S.p.A., Milan JB-P5 Embedding Machine Wuhan Junjie Electronics Co., Ltd. RM2016 Microtome Leica Microsystems Shanghai Co., Ltd. DHG-9140A Oven Shanghai Huibao Instrument Manufacturing Co., Ltd. Small Animal Anesthesia Machine RWD510 Shenzhen Reword Life Science Co., Ltd. Microwave Oven P70D20TL-P4 Galanz Microwave Appliance Co., Ltd. Upright Fluorescence Microscope Nikon Eclipse C1 Nikon Corporation, Japan Scanner 3DHISTECH Pannoramic MIDI 3DHISTECH Ltd., Hungary 2 Experimental Methods 2.1 Preparation of Yiqi Xuanfei Huatan Decoction (YQXFHT) A multifunctional casserole was selected as the equipment. First, take 12 g of Ephedra sinica and 60 g of Gypsum fibrosum, add 2100 mL of water, boil, and then simmer for 30 min. Then add 20 g of Armeniaca vulgaris, 20 g of Glycyrrhiza uralensis, 24 g of Astragalus membranaceus, 20 g of stir-fried Atractylodes macrocephala, 12 g of Saposhnikovia divaricata, 24 g of Forsythia suspensa, and 18 g of Pinellia ternata that have been soaked in 500 mL of water. After boiling, simmer for 40 min. Conduct water bath concentration until it is concentrated to 76.9 mL.

[0046] 2.2 Preparation of Positive Drug Take Xuebijing Injection (XBJ), add normal saline, and dilute it to 10 mL / kg to obtain the positive drug solution.

[0047] 2.3.1 Animal Grouping and Administration After one week of adaptive feeding, 64 male BALB / C mice were randomly divided into a blank group, a model group, a 1 / 4-dose Yiqi Xuanfei Huatan Decoction group (1 / 4-YQXFHT), a 1 / 2-dose Yiqi Xuanfei Huatan Decoction group (1 / 2-YQXFHT), a Yiqi Xuanfei Huatan Decoction group (YQXFHT), a 2-dose Yiqi Xuanfei Huatan Decoction group (2-YQXFHT), a 4-dose Yiqi Xuanfei Huatan Decoction group (4-YQXFHT), and a positive drug XBJ group, with 8 mice in each group. A mouse ARDS model was induced by intranasal instillation of a mixture of POLY(I:C) and LPS. Each time, the normal group was instilled with normal saline by nasal inhalation, and the other groups were induced with an ARDS mouse experimental model by intranasal instillation of LPS + POLY I:C (10 μg / 50 μL), that is, the concentration was 0.2 mg / mL. The other groups were instilled with 50 μL of normal saline by nasal inhalation for modeling, and the modeling time was 14 days. Two weeks after modeling, 3 mice were randomly sacrificed for histological evaluation. Based on the successful modeling, drug administration was carried out. The normal group and the model group were gavaged with normal saline. 1 / 4-YQXFHT, 1 / 2-YQXFHT, YQXFHT, 2-YQXFHT, and 4-YQXFHT were gavaged with YQXFHT at concentrations of 0.342 g / mL, 0.683 g / mL, 1.365 g / mL, 2.73 g / mL, and 5.46 g / mL, respectively. The gavage volume was based on the mouse body weight, 1 mL / 100 g. The XBJ group was injected intraperitoneally at a dose of 1 mL / 100 g. The drug administration cycle was 7 days. After the last drug administration, the mice were fasted but not water-restricted for 12 h. After anesthesia with isoflurane, blood was collected by eye socket puncture and lung tissue was taken, and stored in a -80 °C refrigerator.

[0048] 2.3.2 Histopathological examination The pre-fixed lung tissue was dehydrated and paraffin-embedded with high-concentration ethanol and xylene, and then cut into 4-μm thick sections. After hematoxylin and eosin (H&E) staining, the alveoli and alveolar cavity secretions were observed under a light microscope.

[0049] 2.3.3 Determination of the wet / dry ratio of mouse lung mass After the last drug administration, mouse blood was collected in a centrifuge tube, and 6 mice were randomly selected from each group. The left lung tissue was rinsed with PBS, weighed with absorbent paper and the wet mass was recorded; the lung tissue was dried in an 80 °C oven for 72 h and then weighed and the dry mass was recorded, and then the wet / dry mass ratio (W / T) of the lung tissue was calculated.

[0050] 2.3.4 Determination of IL-6, IL-1β, TNF-α, and IL-10 According to the instructions, ELISA kits were used to determine the concentrations of IL-6, IL-1β, and TNF-α in the serum.

[0051] Determination of SOD, GSH, MDA, and MPO According to the instructions, an ELISA kit was used to measure the concentrations of SOD, GSH, MDA, and MPO in the serum.

[0052] 2.3.5 Statistical analysis All the data in this experiment were expressed as ±SEM, and statistical analysis was performed using GraPhpad prism 8.3. The comparison between groups was performed using t test, p < 0.05 was considered statistically significant.

[0053] 3 Experimental results 3.1 Histopathological results The lung histopathology of mice was evaluated by H&E staining. As Figure 2 shown, the alveoli of mice in the normal group were clear and there was less infiltration of inflammatory cells. However, in the model group, the lung mucosal epithelium was damaged, the alveolar structure was significantly disrupted, there was alveolar hemorrhage, thickening of the alveolar septum, congestion of the pulmonary lobules, deposition of collagen fibers in the alveolar septum, and loosening of the tissues around blood vessels and bronchi, as well as pathological changes such as edema and fibrosis formation. The lung injury in the other groups was alleviated to a certain extent. Among them, the lung injury in the YQXFHT group was relatively mild, and the lung injury in the 1 / 2-YQXFHT, 2-YQXFHT, and XBJ groups was also alleviated to a certain extent. This indicates that YQXFHT and XBJ have similar therapeutic effects.

[0054] 3.2 Effect of YQXFHT on the wet / dry mass ratio of lung tissue in ARDS mice Compared with the control group, the W / D of lung tissue in the model group of mice was significantly increased ( p < 0.05). Compared with the model group, the W / D of L-YQXFHT and M-YQXFHT was significantly decreased ( p < 0.05); compared with the XBJ group, the effect of YQXFHT was similar to that of XBJ, proving that YQXFHT can reduce the degree of pulmonary edema in ARDS mice. The results are shown in Figure 3.

[0055] 3.3 Effect of Yiqi Xuanfei Huatan Decoction on the effect indexes of serum inflammatory factors in mice Compared with the normal group, the levels of TNF-α, IL-6, and IL-1β in the model group were significantly increased, and the level of IL-10 was significantly decreased. Compared with the model group, the levels of TNF-α, IL-6, and IL-1β in the positive drug group were significantly decreased; the levels of TNF-α, IL-6, and IL-1β in each administration group of Yiqi Xuanfei Huatan Decoction were significantly decreased, indicating that YQXFHT can reduce the levels of serum inflammatory factors in ARDS mice. The results are shown in Figure 4 .

[0056] 3.4 Effects of Yiqi Xuanfei Huatan Decoction on Serum Oxidative Stress Indexes in Mice Compared with the normal group, the levels of SOD, GSH, and MDA in the model group were significantly increased. Compared with the model group, the levels of SOD, GSH, and MDA in the positive drug group were significantly decreased; the levels of SOD, GSH, and MDA in each administration group of Yiqi Xuanfei Huatan Decoction were significantly decreased, indicating that YQXFHT can reduce the oxidative stress level in ARDS mice. The results are shown in Figure 5 .

[0057] 3.5 Effects of Yiqi Xuanfei Huatan Decoction on Myeloperoxidase Indexes in Mice Compared with the control group, the MPO in the lung tissue of mice in the model group was significantly increased ( p < 0.05), and compared with the model group, the MPO in the administration group was significantly decreased ( p < 0.05); compared with the XBJ group, the effect of YQXFHT was similar to that of XBJ, proving that YQXFHT can reduce MPO in ARDS mice. The results are as Figure 6 shown.

[0058] In this invention, an ARDS model was established by intranasal administration of POLY(I:C) and LPS, and the pharmacodynamic effects of YQXFHTT in the treatment of ARDS were evaluated. TLR 4 and TLR 3 are essential immune sensors in the early stage of bacterial and viral infections. LPS is a key component of the cell wall of Gram-negative bacteria, and polyinosinic acid: polycytidylic acid (POLY I:C) is an artificial double-stranded ribonucleic acid and is the most studied ligand for TLR4 and TLR3. Administration of LPS or POLY I:C can cause acute inflammation and hypoxia pathology. It has been reported that intranasal challenge with LPS and POLY I:C can cause ALI by stimulating TLR4 and TLR3 in lung cells, leading to a sudden surge in the production of cytokines and chemokines, but the key mediators involved in the pathogenesis have not been fully understood. The cytokine storm mediated by IL-6 in ARDS contributes to blood coagulation and may lead to multiple organ failure, which is the cause of many sudden deaths after pneumonia. Therefore, in this invention, a model was established to simulate the lung injury observed in ARDS. Intranasal delivery of LPS and POLY I:C was continued for 14 days, accompanied by treatment with YQXFHT for 7 days. Related inventions have shown that traditional Chinese medicine has good curative effects in reducing inflammation in ARDS lung tissue, reducing mortality, and improving prognosis.

[0059] The HE staining results showed that the alveolar morphology of the mice in the normal group was relatively regular, with clear and complete structure. Compared with the normal group, in the lung tissue of the mice in the model group, large areas of alveolar wall thickening were visible, accompanied by infiltration of a large number of lymphocytes, neutrophils and macrophages. Inflammatory cell infiltration was seen in a ring around the blood vessels, accompanied by varying degrees of hemorrhage and edema. The pulmonary conditions of each dose administration group improved to varying degrees compared with the M group, with reduced hemorrhage and a decrease in the area of inflammatory infiltration. The same results were produced when each administration group was compared with the Xuebijing group.

[0060] A core feature of ARDS is increased pulmonary capillary permeability. Under normal circumstances, the blood-gas barrier between the alveoli and capillaries remains tight, preventing fluid from entering the alveoli from the blood vessels. However, ARDS can cause damage to the pulmonary capillary endothelial cells and alveolar epithelial cells, resulting in increased vascular permeability, and leakage of fluid, proteins and other components into the pulmonary interstitium and alveoli, forming pulmonary edema. The wet / dry ratio of the lungs of the mice in the model group was significantly higher than that of the normal group, and after administration, the wet / dry ratio was also significantly lower than that of the model group. The results showed that YQXFHT could treat the pulmonary edema in ARDS mice.

[0061] In the early stage of ARDS, exogenous or endogenous stimuli (such as bacterial and viral infections, trauma, etc.) activate the immune system, leading to a large number of inflammatory cells entering the lung tissue. These cells further exacerbate the local inflammatory response by secreting mediators such as cytokines, chemokines and reactive oxygen species. Among them, neutrophils play a very important role in ARDS. They are attracted to the damaged lung tissue and release a variety of enzymes and cytokines, which exacerbate the inflammatory response and make the lung tissue more vulnerable. Macrophages also play a key role in the inflammatory response. They play an important role in recognizing pathogens, clearing cell debris and secreting cytokines. The factors secreted by macrophages exacerbate the inflammation and are involved in the process of cell damage. In this invention, an ELISA kit was used to detect the levels of inflammatory factors in the serum of ARDS rats. The results showed that compared with the normal group, the levels of IL-1β, IL-6 and TNF-α in the model group were significantly increased. Compared with the model group, the levels of inflammatory factors in each administration group decreased to varying degrees. Among them, the high-dose group and the positive drug group had a larger decrease in the levels of inflammatory factors. These results indicated that YQXFHT could improve the increase in the levels of inflammatory factors caused by ARDS.

[0062] Superoxide dismutase (SOD) is an important class of antioxidant enzymes that can catalyze superoxide anion radicals (O 2The disproportionation reaction of superoxide anion radicals (O₂⁻) converts them into hydrogen peroxide (H₂O₂) and oxygen (O₂). Since superoxide anion radicals are highly reactive and can trigger oxidative damage to cells and tissues, SOD plays a key role in cellular defense against oxidative damage. In ARDS, GSH plays a crucial role, mainly through its antioxidant and cytoprotective functions. As a potent antioxidant, GSH can effectively scavenge free radicals and oxidants in the body, reducing the damage caused by oxidative stress. MDA is one of the end products of lipid peroxidation and is closely related to the level of oxidative stress and the severity of ARDS. Clinical studies have shown that the level of MDA in the body of ARDS patients often increases, and this change is closely related to the severity of the disease, prognosis, and decline in lung function. Therefore, MDA is widely used as a biomarker of oxidative stress to evaluate the degree of oxidative damage and prognosis of ARDS. The results showed that compared with the normal group, the levels of SOD and GSH in the model group were significantly decreased. Compared with the model group, the levels of SOD and GSH in each drug-administered group increased to varying degrees. Among them, the high-dose group and the positive drug group had a greater decrease in the level of inflammatory factors, while the results of MDA were exactly opposite to those of SOD and GSH. These results indicate that YQXFHT can improve the level of oxidative stress caused by ARDS.

Claims

1. An invigorating qi, dispersing lung qi and resolving phlegm traditional Chinese medicine composition for treating acute respiratory distress syndrome, characterized in that, It is made from the following traditional Chinese medicine raw materials: Ephedra, Astragalus membranaceus, Gypsum fibrosum, Atractylodes macrocephala Koidz. stir-fried, Forsythia suspensa, Pinellia ternata, Armeniaca vulgaris, Saposhnikovia divaricata, Glycyrrhiza uralensis Fisch.

2. The traditional Chinese medicine composition for supplementing qi, dispersing lung qi and resolving phlegm for treating acute respiratory distress syndrome according to claim 1, wherein, It is made from the following traditional Chinese medicine raw materials in parts by weight: Ephedra 12 - 36 parts, Astragalus membranaceus 24 - 72 parts, Gypsum fibrosum 60 - 180 parts, Atractylodes macrocephala Koidz. stir-fried 20 - 60 parts, Forsythia suspensa 24 - 72 parts, Pinellia ternata 18 - 54 parts, Armeniaca vulgaris 20 - 60 parts, Saposhnikovia divaricata 12 - 36 parts, Glycyrrhiza uralensis Fisch. 20 - 60 parts.

3. The traditional Chinese medicine composition for supplementing qi, dispersing lung qi and resolving phlegm for treating acute respiratory distress syndrome according to claim 2, wherein, It is made from the following traditional Chinese medicine raw materials in parts by weight: Ephedra 12 - 24 parts, Astragalus membranaceus 24 - 48 parts, Gypsum fibrosum 60 - 120 parts, Atractylodes macrocephala Koidz. stir-fried 20 - 40 parts, Forsythia suspensa 24 - 48 parts, Pinellia ternata 18 - 36 parts, Armeniaca vulgaris 20 - 40 parts, Saposhnikovia divaricata 12 - 24 parts, Glycyrrhiza uralensis Fisch. 20 - 40 parts.

4. The traditional Chinese medicine composition for supplementing qi, dispersing lung qi and resolving phlegm for treating acute respiratory distress syndrome according to claim 3, wherein, It is made from the following traditional Chinese medicine raw materials in parts by weight: Ephedra 12 parts, Astragalus membranaceus 24 parts, Gypsum fibrosum 60 parts, Atractylodes macrocephala Koidz. stir-fried 20 parts, Forsythia suspensa 24 parts, Pinellia ternata 18 parts, Armeniaca vulgaris 20 parts, Saposhnikovia divaricata 12 parts, Glycyrrhiza uralensis Fisch. 20 parts.

5. A method for preparing a traditional Chinese medicine composition for supplementing qi, promoting lung qi, resolving phlegm to treat acute respiratory distress syndrome according to any one of claims 1 to 4, characterized in that, It includes the following steps: First, take Ephedra and Gypsum fibrosum according to the parts by weight, decoct and extract them with water for a period of time, then add Armeniaca vulgaris, Glycyrrhiza uralensis Fisch., Astragalus membranaceus, Atractylodes macrocephala Koidz. stir-fried, Saposhnikovia divaricata, Forsythia suspensa and Pinellia ternata that have been soaked in water, heat and decoct until boiling, then decoct with slow fire, filter, combine the filtrates, and concentrate to obtain it.

6. The preparation method of a traditional Chinese medicine composition for supplementing qi, promoting lung qi and resolving phlegm for treating acute respiratory distress syndrome according to claim 5, characterized in that, It includes the following steps: First, take Ephedra and Gypsum fibrosum according to the parts by weight, add 5 - 10 times the amount of water and decoct and extract for 20 - 40 min, then add Armeniaca vulgaris, Glycyrrhiza uralensis Fisch., Astragalus membranaceus, Atractylodes macrocephala Koidz. stir-fried, Saposhnikovia divaricata, Forsythia suspensa and Pinellia ternata that have been soaked in water, add 5 - 20 times the volume of water based on the weight of the medicinal materials, heat to boiling, then decoct with slow fire for 30 - 120 minutes, filter; take the medicinal residues and continue to add 5 - 20 times the volume of water, heat to boiling, then decoct with slow fire for 30 - 120 minutes, filter, combine the filtrates, and concentrate to obtain it.

7. A detection method for a traditional Chinese medicine composition for replenishing qi, promoting lung qi and resolving phlegm for treating acute respiratory distress syndrome according to any one of claims 1 to 4, characterized in that, It includes the following steps: (1) Preparation of the test solution First, take Ephedra and Gypsum fibrosum according to the parts by weight, add 5 - 10 times the amount of water and decoct and extract for 20 - 40 min, then add Armeniaca vulgaris, Glycyrrhiza uralensis Fisch., Astragalus membranaceus, Atractylodes macrocephala Koidz. stir-fried, Saposhnikovia divaricata, Forsythia suspensa and Pinellia ternata that have been soaked in water, add 5 - 20 times the volume of water based on the weight of the medicinal materials, heat to boiling, then decoct with slow fire for 30 - 120 minutes, filter; take the medicinal residues and continue to add ​ 8. The detection method of the traditional Chinese medicine composition for supplementing qi, dispersing the lung and resolving phlegm for treating acute respiratory distress syndrome according to claim 7, wherein, ​ First, take Ephedrae Herba and Gypsum Fibrosum by weight parts. Add 5 times the amount of water and decoct for 30 minutes. Then add Armeniacae Semen Amarum, Glycyrrhizae Radix, Astragali Radix, Atractylodis Macrocephalae Rhizoma Praeparata, Saposhnikoviae Radix, Forsythiae Fructus, and Pinelliae Rhizoma Praeparata which have been soaked in water. Add 10 times the volume of water based on the weight of the medicinal materials. After heating to boiling, decoct with gentle heat for 40 minutes and filter. Take the medicinal residues, continue to add 8 times the volume of water, heat to boiling, and decoct with gentle heat for 30 minutes, then filter. Combine the filtrates, concentrate, and filter through a 0.25 μm microporous membrane to prepare the test solution.

9. The quality inspection method of cinobufacini capsules according to claim 7, characterized in that, The chromatographic conditions in step (2) are as follows: Waters ACQUITY UPLC HSS T3 chromatographic column, with a specification of 150 mm × 2.1 mm, 1.8 μm, a volume flow rate of 0.3 mL / min, a column temperature of 35 °C, the mobile phase is 0.1% formic acid aqueous solution A - acetonitrile B, and the gradient elution process is as follows: The mass spectrometry conditions are as follows: Negative ion mode, source conditions: capillary voltage is 2.5 kV, sample cone temperature is 40 °C, source temperature is 120 °C, desolvation gas temperature is 280 °C, cone gas flow rate is 50 L / h, desolvation gas is N2, and the flow rate is 600 L / h; the data acquisition in this mode covers the mass spectrometry range of mass-to-charge ratio 50 - 1200 Da; In the positive ion mode, source conditions: capillary voltage is 3.0 kV, sample cone temperature is 55 °C, source temperature is 100 °C, desolvation gas temperature is 350 °C, cone gas flow rate is 50 L / h, desolvation gas N2 flow rate is 800 L / h; the data acquisition in this mode covers the mass spectrometry range of mass-to-charge ratio 50 - 1200 Da, and the control of data acquisition and analysis is carried out by using Waters MassLynx 4.2 software.

10. Use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a drug for treating acute respiratory distress syndrome.

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