Traditional Chinese medicine composition for treating acute respiratory distress syndrome and application thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine preparation, in particular to a traditional Chinese medicine composition for treating acute respiratory distress syndrome and application thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 20 to 25 parts of herba ephedrae, 20 to 25 parts of radix stemonae, 15 to 20 parts of radix ophiopogonis, 10 to 20 parts of rhizoma polygoni cuspidati, 5 to 10 parts of lapis chloriti, 10 to 20 parts of rhizoma pinellinae praeparata, 15 to 20 parts of radix astragali seu hedysari, 10 to 15 parts of rhizoma atractylodis macrocephalae, 15 to 20 parts of radix rehmanniae praeparata, 10 to 15 parts of fructus corni, 15 to 20 parts of herba rhodiolae, 10 to 20 parts of herba leonuri, 10 to 15 parts of herba taxilli, 10 to 15 parts of radix dipsaci and 10 to 20 parts of radix glycyrrhizae. The preparation method comprises the following steps: weighing the traditional Chinese medicine composition according to the formula dosage, then adding water which is 5-20 times of the total weight of the traditional Chinese medicine composition, and decocting for three times to obtain a traditional Chinese medicine decoction; combining the traditional Chinese medicine decoction, filtering, and concentrating until the relative density is 1.05-1.10 to obtain a traditional Chinese medicine extract; and adding clinically acceptable auxiliary materials into the traditional Chinese medicine extract, and preparing by adopting a conventional preparation mode. The traditional Chinese medicine composition can realize combination of deficiency and excess and simultaneous treatment of heart, lung, liver, spleen and kidney, and finally achieves the effect of fully treating ARDS.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating acute respiratory distress syndrome and its application. Background Art

[0002] Acute Respiratory Distress Syndrome (ARDS) refers to a condition where the original cardiopulmonary function is normal, but due to severe diseases inside and outside the lungs, the permeability of pulmonary microvessels increases, and the alveoli exude protein-rich fluid, leading to pulmonary edema and the formation of hyaline membranes, which may be accompanied by pulmonary interstitial fibrosis. It is a severe stage of acute lung injury. Clinically, it is manifested as progressive hypoxemia and respiratory distress, and on pulmonary imaging, it shows heterogeneous exudative lesions, with reduced lung volume, decreased lung compliance, and severe ventilation / perfusion ratio imbalance as its pathophysiological characteristics.

[0003] Currently, the treatment of ARDS still mainly focuses on the treatment of the primary disease and supportive treatment, by improving cardiopulmonary function, reducing pulmonary edema, lowering pulmonary permeability and inflammatory response to increase the success rate of treatment. The anti-inflammatory effects of natural compounds have been confirmed through years of clinical practice, with advantages such as multiple targets, rich resources, strong anti-inflammatory ability, and few adverse reactions. Some studies have proposed that ARDS belongs to the category of sudden asthma in traditional Chinese medicine. The lung governs qi throughout the body and is responsible for the respiratory function. Various reasons, such as the invasion of pathogenic factors of the six climatic exopathogens, or traumatic injuries and critical internal medical diseases, can damage the qi of the lung and cause ARDS. In existing traditional Chinese medicine syndrome differentiation and treatment methods, it is considered that ARDS belongs to the syndrome of excessive heat in the qi aspect: sudden onset of rapid and labored breathing, even with flaring of the alae nasi, body shaking and abdominal heaving, high fever, sweating, thirst and restlessness, or accompanied by cough, thick and yellow phlegm that is difficult to expectorate, red tongue, thin and yellow dry coating, and rapid and forceful pulse; therefore, Baihu Decoction plus Ephedra can be taken to clear heat and relieve asthma by dispersing the lung. In some other traditional Chinese medicine syndrome differentiation and treatment methods, it is considered that ARDS belongs to the syndrome of phlegm-fluid obstructing the lung: after chest trauma, rapid and labored breathing, heaving chest, flaring of the alae nasi, cough, expectoration of white sticky phlegm, chest tightness, white and greasy tongue coating, and string-like and slippery pulse, and Xuanfei Shenshi Decoction can be taken to disperse the lung, resolve fluid-retention, promote blood circulation and relieve chest tightness. In still some other traditional Chinese medicine syndrome differentiation and treatment methods, it is considered that ARDS belongs to the syndrome of excessive heat in the yangming fu-organ: rapid and labored breathing, high and forceful breathing, constipation, tidal fever, sweating on the hands and feet, abdominal distension, hard on palpation, blurred vision, immobility of the eye balls, or even delirium, feeling the bedclothes and groping, yellow and scorched tongue coating with prickles, and deep and solid pulse, and Wuhu Decoction can be taken to purge heat from the fu-organ and relieve asthma by clearing the lung.

[0004] Although some existing traditional Chinese medicine syndrome differentiation and treatment methods currently have a certain effect on ARDS, there are few traditional Chinese medicine prescriptions for treating ARDS that fully combine the syndrome differentiation methods of combining deficiency and excess, dispersing the lung and relieving asthma, treating the heart and lung simultaneously, tonifying the kidney and strengthening the tendons, and replenishing middle qi and benefiting qi. Summary of the Invention

[0005] In view of the deficiencies existing in the prior art, the present invention provides a traditional Chinese medicine composition for treating acute respiratory distress syndrome and its application.

[0006] Specifically, the present invention provides a traditional Chinese medicine composition for treating acute respiratory distress syndrome, which is composed of the following raw medicinal materials: Ephedra, Stemona japonica, Ophiopogon japonicus, Polygonum cuspidatum, Chlorite-schist, Pinellia ternata, Astragalus membranaceus, Atractylodes macrocephala, Rehmannia glutinosa, Cornus officinalis, Rhodiola rosea, Leonurus japonicus, Taxillus chinensis, Dipsacus asperoides, Glycyrrhiza uralensis.

[0007] As a further illustration of the present invention, the traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: 20 - 25 parts of Ephedra, 20 - 25 parts of Stemona japonica, 15 - 20 parts of Ophiopogon japonicus, 10 - 20 parts of Polygonum cuspidatum, 5 - 10 parts of Chlorite-schist, 10 - 20 parts of Pinellia ternata, 15 - 20 parts of Astragalus membranaceus, 10 - 15 parts of Atractylodes macrocephala, 15 - 20 parts of Rehmannia glutinosa, 10 - 15 parts of Cornus officinalis, 15 - 20 parts of Rhodiola rosea, 10 - 20 parts of Leonurus japonicus, 10 - 15 parts of Taxillus chinensis, 10 - 15 parts of Dipsacus asperoides, 10 - 20 parts of Glycyrrhiza uralensis.

[0008] As a further illustration of the present invention, the traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: 20 parts of Ephedra, 20 parts of Stemona japonica, 15 parts of Ophiopogon japonicus, 15 parts of Polygonum cuspidatum, 5 parts of Chlorite-schist, 15 parts of Pinellia ternata, 20 parts of Astragalus membranaceus, 15 parts of Atractylodes macrocephala, 15 parts of Rehmannia glutinosa, 10 parts of Cornus officinalis, 15 parts of Rhodiola rosea, 10 parts of Leonurus japonicus, 10 parts of Taxillus chinensis, 10 parts of Dipsacus asperoides, 15 parts of Glycyrrhiza uralensis.

[0009] Application of the traditional Chinese medicine composition described in any one of the above in the preparation of a drug for treating acute respiratory distress syndrome.

[0010] As a further illustration of the present invention, the dosage form for treating acute respiratory distress syndrome is an oral preparation, and the oral preparation is selected from any one of granules, tablets, capsules, powders, decoctions or pills.

[0011] The present invention also provides a preparation method of a traditional Chinese medicine preparation for treating acute respiratory distress syndrome, including the following steps: S1. Weigh the processed products of the traditional Chinese medicine composition provided in any one of the above according to the formula dosage, and then decoct with water 5 - 20 times the total weight of the above traditional Chinese medicine composition for three times to obtain a traditional Chinese medicine decoction; S2. Combine, filter and concentrate the traditional Chinese medicine decoction obtained from the three decoctions in step S1 to a relative density of 1.05 - 1.10 to obtain a traditional Chinese medicine extract; S3. Add clinically acceptable excipients to the traditional Chinese medicine extract obtained in step S2, and carry out preparation by conventional preparation methods to make any one of clinically acceptable granules, tablets, capsules, powders, decoctions or pills.

[0012] As a further illustration of the present invention, when preparing the granule, step S3 specifically includes: Step S31: Add dextrin accounting for 3 - 7% of the total weight of the traditional Chinese medicine composition to the traditional Chinese medicine extract obtained in step S2, and perform spray drying to obtain a spray-dried powder; Step S32: Add dextrin accounting for 15 - 20% of the total weight of the granule preparation to be prepared to the dried powder obtained in step S31 and mix evenly to prepare the final granule.

[0013] Ephedra: It is warm in nature, pungent and slightly bitter in taste, and has the effects of inducing sweating and dispelling cold, dispersing the lung qi and relieving asthma, promoting diuresis and alleviating edema, and can treat wind-cold cold, chest distress and cough, wind-water edema, bronchial asthma and other diseases.

[0014] Stemona root: Sweet, bitter, slightly warm. It belongs to the lung meridian. It has the effects of relieving cough and reducing sputum, warming and moistening the lung qi, and dispersing heat and relieving the exterior, and is used for pulmonary tuberculosis, chronic cough, pulmonary tuberculosis cough, whooping cough, asthma and other diseases.

[0015] Dwarf lilyturf tuber: Sweet, slightly bitter, cool in nature, has the effects of nourishing yin and clearing heat, moistening the lung and relieving cough, and also has the functions of strengthening the heart, promoting diuresis and antibacterial. It is applicable to various symptoms such as yin deficiency of the stomach, damage of stomach yin by heat, deficiency of lung yin, and deficiency of heart yin.

[0016] Japanese knotweed: Slightly bitter in taste, slightly cold in nature. It belongs to the liver, gallbladder and lung meridians. It is effective in promoting diuresis and excreting jaundice, clearing heat and detoxifying, removing stasis and relieving pain, and relieving cough and reducing sputum. It is mainly used for damp-heat jaundice, gonorrhea, leukorrhea, rheumatic arthralgia, carbuncle and sore toxin, scald by fire and water, amenorrhea, mass, traumatic injury, and cough due to lung heat.

[0017] Lapis chloriti: Sweet, salty, flat. It belongs to the lung, heart and liver meridians, and can reduce phlegm and lower qi, and calm the liver and suppress fright. It is used for stubborn phlegm binding, cough and dyspnea, restlessness and chest distress.

[0018] Pinellia ternata (processed): Pungent, warm. It belongs to the spleen meridian, stomach meridian and lung meridian. It has the function of drying dampness and resolving phlegm, and is used for excessive phlegm and cough, dizziness and palpitation due to phlegm retention, and wind-phlegm dizziness, syncope due to phlegm headache.

[0019] Astragalus membranaceus: Sweet, warm. It belongs to the spleen and lung meridians. It has the functions of invigorating qi and lifting yang, strengthening the defensive qi and consolidating the exterior, expelling toxins and promoting granulation, and promoting diuresis and alleviating edema. It is used for treating syndromes of qi deficiency of the spleen and lung and sinking of middle qi.

[0020] Atractylodes macrocephala: Bitter, sweet, warm in nature, non-toxic. Meridian tropism: It belongs to the spleen and stomach meridians. It can invigorate qi and strengthen the spleen, and treat the syndrome of qi deficiency of the spleen and stomach; dry dampness and promote diuresis, and treat edema and phlegm retention syndrome.

[0021] Prepared rehmannia root: Sweet, slightly warm in nature, has the effects of enriching blood and nourishing yin, and replenishing essence and marrow, and is mainly used for yin deficiency of the liver and kidney, soreness and weakness of the waist and knees, and steaming bone and tidal fever.

[0022] Asiatic cornelian cherry fruit: Sour, astringent, slightly warm in nature; it belongs to the liver and kidney meridians. It can tonify the liver and kidney, and astringe essence and prevent spermatorrhea. It is used for dizziness and tinnitus, soreness of the waist and knees, profuse sweating and collapse and other diseases.

[0023] Rhodiola rosea: Its nature and flavor are cold, sweet, and astringent. It pertains to the spleen and lung meridians. It has the efficacy of promoting blood circulation and removing blood stasis, and can tonify qi, nourish essence and blood, enhance resistance, and counteract symptoms of hypoxia.

[0024] Leonurus japonicus: Bitter, sweet, slightly cold. It pertains to the liver and kidney meridians. It has the efficacy of promoting blood circulation to regulate menstruation, promoting diuresis to alleviate edema, and cooling blood to eliminate skin eruptions. It can promote blood circulation to regulate menstruation and promote diuresis to reduce swelling.

[0025] Taxillus sutchuenensis: Its nature and flavor are bitter, sweet, and neutral. It pertains to the liver and kidney meridians. It can nourish blood, tonify the liver and kidney, dispel wind-dampness, and strengthen tendons and bones.

[0026] Dipsacus asper: Bitter, pungent, sweet, slightly warm in nature. It pertains to the liver and kidney meridians. It has the functions of tonifying the liver and kidney, promoting blood circulation in the meridians, and reconnecting tendons and bones. It is used to treat soreness and pain in the waist and legs, weakness in the knees, and weakness in the feet caused by deficiency of the liver and kidney and unsmooth blood circulation in the meridians.

[0027] Acute respiratory distress syndrome is an acute respiratory failure characterized by pulmonary edema, formation of hyaline membranes, and hypoxemia. The lung is in charge of qi, and the heart is in charge of blood vessels. Therefore, when carrying out traditional Chinese medicine syndrome differentiation and treatment of ARDS in the present invention, full consideration is given to treating the heart and lung simultaneously, tonifying the middle qi and promoting blood circulation in the meridians. At the same time, considering the heat-phlegm excess syndrome of ARDS and deficiency syndromes such as deficiency of lung qi or weakness of the spleen qi, dispersing the lung qi and clearing heat, reducing phlegm and stopping vomiting, soothing the liver and strengthening the spleen, and tonifying the kidney and strengthening tendons. In the formula: Ephedra, Stemona japonica, and Ophiopogon japonicus are the monarch drugs, dispersing the lung qi and relieving asthma, clearing heat and promoting fluid production; Polygonum cuspidatum, Glaucocalycium, and Pinellia ternata are the ministerial drugs, clearing heat and promoting diuresis, reducing phlegm and calming the liver, suppressing the adverse qi and stopping vomiting; Astragalus membranaceus, Atractylodes macrocephala, Rehmannia glutinosa, and Cornus officinalis are the adjuvant drugs, tonifying the middle qi, strengthening the spleen and drying dampness, and replenishing essence and marrow; Rhodiola rosea, Leonurus japonicus, Taxillus sutchuenensis, and Dipsacus asper are the guiding drugs, tonifying qi and promoting blood circulation, promoting blood circulation in the meridians and relieving asthma, tonifying the kidney and strengthening tendons. Coupled with Glycyrrhiza uralensis to harmonize the properties of various drugs, it realizes the combination of excess and deficiency, and the simultaneous treatment of the heart, lung, liver, spleen, and kidney, and finally achieves the effect of fully treating ARDS.

[0028] Compared with the prior art, the present invention has the following beneficial technical effects: In the present invention, Ephedra, Stemona japonica, and Ophiopogon japonicus are the monarch drugs, dispersing the lung qi and relieving asthma, clearing heat and promoting fluid production; Polygonum cuspidatum, Glaucocalycium, and Pinellia ternata are the ministerial drugs, clearing heat and promoting diuresis, reducing phlegm and calming the liver, suppressing the adverse qi and stopping vomiting; Astragalus membranaceus, Atractylodes macrocephala, Rehmannia glutinosa, and Cornus officinalis are the adjuvant drugs, tonifying the middle qi, strengthening the spleen and drying dampness, and replenishing essence and marrow; Rhodiola rosea, Leonurus japonicus, Taxillus sutchuenensis, and Dipsacus asper are the guiding drugs, tonifying qi and promoting blood circulation, promoting blood circulation in the meridians and relieving asthma, tonifying the kidney and strengthening tendons. Coupled with Glycyrrhiza uralensis to harmonize the properties of various drugs, it realizes the combination of excess and deficiency, and the simultaneous treatment of the heart, lung, liver, spleen, and kidney, and finally achieves the effect of fully treating ARDS. Description of the Drawings

[0029] Figure 1 It is a HE staining diagram of the lungs of mice. Among them, (a)-(e) are the HE staining diagrams of the lungs of mice in the blank group, model group, Example 1 (low), Example 1 (medium), and Example 1 (high) groups respectively. Detailed Embodiments

[0030] The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0031] Example 1 A traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: 20 parts of Ephedra, 20 parts of Stemona Root, 15 parts of Ophiopogon Root, 15 parts of Polygonum Cuspidatum Root, 5 parts of Chlorite Schist, 15 parts of Pinellia Ternata (processed with Rhizoma Zingiberis Recens), 20 parts of Astragalus Root, 15 parts of Atractylodes Macrocephala, 15 parts of Rehmannia Root (prepared), 10 parts of Dogwood Fruit, 15 parts of Rhodiola Root, 10 parts of Motherwort Herb, 10 parts of Taxillus Twig, 10 parts of Dipsacus Root, and 15 parts of Licorice Root.

[0032] Example 2 A traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: 25 parts of Ephedra, 25 parts of Stemona Root, 20 parts of Ophiopogon Root, 10 parts of Polygonum Cuspidatum Root, 10 parts of Chlorite Schist, 10 parts of Pinellia Ternata (processed with Rhizoma Zingiberis Recens), 15 parts of Astragalus Root, 10 parts of Atractylodes Macrocephala, 20 parts of Rehmannia Root (prepared), 15 parts of Dogwood Fruit, 20 parts of Rhodiola Root, 20 parts of Motherwort Herb, 15 parts of Taxillus Twig, 15 parts of Dipsacus Root, and 20 parts of Licorice Root.

[0033] Example 3 A traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: 23 parts of Ephedra, 22 parts of Stemona Root, 17 parts of Ophiopogon Root, 20 parts of Polygonum Cuspidatum Root, 7 parts of Chlorite Schist, 20 parts of Pinellia Ternata (processed with Rhizoma Zingiberis Recens), 18 parts of Astragalus Root, 13 parts of Atractylodes Macrocephala, 18 parts of Rehmannia Root (prepared), 12 parts of Dogwood Fruit, 18 parts of Rhodiola Root, 15 parts of Motherwort Herb, 12 parts of Taxillus Twig, 13 parts of Dipsacus Root, and 10 parts of Licorice Root.

[0034] Comparative Examples 1-7 all provide a traditional Chinese medicine composition, and the specific raw medicinal materials and their dosages of the traditional Chinese medicine compositions in Comparative Examples 1-7 are shown in Table 1 below.

[0035]

[0036] In the table, "-" indicates that the corresponding raw medicinal material is not added to the traditional Chinese medicine composition. In Comparative Example 1, 20* means replacing 20 parts of Stemona Root with 20 parts of Cinnamon Twig, and 15* means replacing 15 parts of Ophiopogon Root with 15 parts of Apricot Kernel. In Comparative Example 3, 15* means replacing 15 parts of Pinellia Ternata (processed with Rhizoma Zingiberis Recens) with 15 parts of Fresh Ginger. In Comparative Example 4, 15* means replacing 5 parts of Chlorite Schist with 15 parts of Fritillaria Thunbergii Bulb. In Comparative Example 7, 10* means replacing 10 parts of Motherwort Herb with 10 parts of Salvia Miltiorrhiza Root, and 10 + means replacing 10 parts of Taxillus Twig with 10 parts of Magnolia Officinalis Bark.

[0037] The raw medicinal materials in the above examples and comparative examples were all commercially available Chinese medicine processed slices.

[0038] The traditional Chinese medicine compositions provided in the above examples and comparative examples were made into granule preparations for the treatment of acute respiratory distress syndrome. The specific preparation process was as follows: S1. Weigh the traditional Chinese medicine compositions provided in the above examples and comparative examples according to the formula dosages, and then decoct them three times with 10 times the total weight of the above traditional Chinese medicine compositions in water to obtain a traditional Chinese medicine decoction. S2. Combine, filter, and concentrate the traditional Chinese medicine decoctions obtained from the three decoctions in step S1 to a relative density of 1.05 - 1.10 (60 °C) to obtain a traditional Chinese medicine extract. S3. Add 5% of dextrin based on the total weight of the traditional Chinese medicine composition to the traditional Chinese medicine extract obtained in step S2, and perform spray drying to obtain a spray-dried powder. S4. Add 18% of dextrin based on the total weight of the granule preparation to be prepared to the dried powder obtained in step S3 and mix evenly to make the final granule preparation.

[0039] Experimental examples 1. Animal experiments: 1.1 Experimental drugs: The granule preparations made from the traditional Chinese medicine formulas provided in Example 1 and Comparative Examples 1 - 7 above were reserved, and dexamethasone (DEX - Shanghai Yuanye Bio-Technology Co., Ltd.); 1.2 Experimental animals: 130 SPF - grade male Wistar mice, from the Animal Experiment Center of Jiamusi Traditional Chinese Medicine Hospital. After the mice were bought, they were placed under SPF - grade conditions and adaptively raised for 3 days before the experiment, with a body weight of 18 - 22 g.

[0040] 1.3 Method for constructing an animal model The experimental mice were randomly divided into a blank control group, a model group, a positive control group, a low - dose group of Example 1, a medium - dose group of Example 1, a high - dose group of Example 1, and high - dose groups of Comparative Examples 1 - 7, with 10 mice in each group.

[0041] The mice in each group were anesthetized by intraperitoneal injection of 10% chloral hydrate at 300 mg / kg, and then the mice were fixed on the operating board. The neck was disinfected, the neck skin was longitudinally incised, the subcutaneous tissue was dissected, and the trachea was exposed; except for the blank control group, the mice in the other groups were injected with lipopolysaccharide into the trachea at 0.5 mg / kg to establish a mouse model of acute respiratory distress syndrome. After injection, the mice were immediately set upright and gently shaken several times to enable the liquid to be evenly distributed in the lungs, and then the wound was sutured. The blank control group was injected with the same dose of 0.9% sodium chloride injection. After the mice woke up naturally, they were administered according to the following drug administration standards for 7 days, and then relevant indicators were detected.

[0042] The drug used in the above positive control group was dexamethasone. The drugs used in the three dose groups (low, medium, and high) of Example 1 were the Chinese medicine granules obtained by using the granule preparation method for the Chinese medicine formula provided in Example 1. The drugs used in the high dose groups of Comparative Examples 1-7 were the Chinese medicine granule preparations obtained by using the granule preparation method for the Chinese medicine formulas provided in Comparative Examples 1-7. The administration doses of mice in each group were as follows: Low dose group of Example 1: 2.5 g / kg of the Chinese medicine granules of Example 1 were dissolved in 0.4 mL of normal saline and administered by gavage, once a day for 7 consecutive days.

[0043] Medium dose group of Example 1: 5 g / kg of the Chinese medicine granules of Example 1 were dissolved in 0.4 mL of normal saline and administered by gavage, once a day for 7 consecutive days.

[0044] High dose group of Example 1: 10 g / kg of the Chinese medicine granules of Example 1 were dissolved in 0.4 mL of normal saline and administered by gavage, once a day for 7 consecutive days.

[0045] High dose groups of Comparative Examples 1-7: 10 g / kg of the Chinese medicine granules of Comparative Examples 1-7 were dissolved in 0.4 mL of normal saline and administered by gavage, once a day for 7 consecutive days.

[0046] Blank control group and model control group: 0.4 mL of normal saline was administered by gavage, once a day for 7 consecutive days.

[0047] Positive control group: 3 mg / kg of dexamethasone was dissolved in 0.4 mL of normal saline and administered by gavage, once a day for 7 consecutive days.

[0048] 1.4 Detection indexes: Blood was taken from the posterior orbital vein of mice, and the contents of inflammatory factors: IL-6, TNF-α, and IL-1β in the serum were detected using an ELISA kit.

[0049] After opening the thoracic cavity of the mice, 1 mL of 0.9% sodium chloride solution was instilled into the trachea for lavage, and the bronchoalveolar lavage fluid (BALF) was collected. The contents of inflammatory factors: IL-6, TNF-α, and IL-1β in the BALF were detected using an ELISA kit.

[0050] Each group of mice was sacrificed, the lung tissues were dissected and taken out, fixed with formalin, embedded in paraffin, sectioned, stained with HE, and the pathological changes of the lungs were observed under a microscope at 400 times magnification. The lung injury and inflammatory cell infiltration were scored. The specific scoring criteria were as follows: 0 points: normal; 1 point: mild (lesion less than 20%); 2 points: moderate (lesion 20% - 40%); 3 points: moderately severe (lesion 40% - 60%); 4 points: severe (lesion greater than 60%).

[0051] 1.5 Statistical method: The SPSS 17.0 statistical software package was used to analyze and organize the data. The two-sample t-test for means was used for inter-group comparison, and P < 0.05 was considered statistically significant.

[0052] 1.6 Experimental results: 1.61 Effects on the release of inflammatory factors in acute lung injury are shown in Tables 2 and 3.

[0053]

[0054] Note: Compared with the blank group, # P < 0.05, ## P < 0.01; compared with the model group, * P < 0.05, ** P < 0.01; compared with the high-dose group of Example 1, ∆ P < 0.05, ∆∆ P < 0.01 (n = 10).

[0055]

[0056] Note: Compared with the blank group, # P < 0.05, ## P < 0.01; compared with the model group, * P < 0.05, ** P < 0.01; compared with the high-dose group of Example 1, ∆ P < 0.05, ∆∆ P < 0.01 (n = 10).

[0057] As shown in Tables 2 and 3, compared with the blank group, the contents of inflammatory factors IL-6, TNF-α, and IL-1β in the BALF and serum of mice in the model group were significantly increased; compared with the mice in the model group, the contents of inflammatory factors IL-6, TNF-α, and IL-1β in the BALF and serum of mice in the groups of Example 1 (low), Example 1 (medium), and Example 1 (high) were significantly decreased; it shows that the traditional Chinese medicine granules provided by the present invention have an obvious improvement effect on mouse lung inflammation. Compared with the high-dose group of Example 1, the contents of inflammatory factors IL-6, TNF-α, and IL-1β in the BALF and serum of mice in the groups of Comparative Example 1-7 were significantly increased, indicating that the traditional Chinese medicine granules provided by the present invention have a significantly better improvement effect on mouse lung inflammation than the traditional Chinese medicine granules provided in the comparative examples. Even if the monarch drug or adjuvant drug in the formula is replaced with common traditional Chinese medicine components or a part of the monarch drug or adjuvant drug is removed, it is difficult to achieve the same medicinal effect as the traditional Chinese medicine formula provided by the present invention, indicating that there is an obvious synergistic cooperation among the 15 traditional Chinese medicines provided by the present invention. While each formula exerts its own efficacy, they are mutually beneficial. All 15 traditional Chinese medicines must be present simultaneously to achieve the ideal effect of improving mouse lung inflammation.

[0058] 1.62 Effects on the lungs of mice with acute lung injury are shown in Table 4 and Figure 1 .

[0059] Figure 1 Among them, (a)-(e) are the HE staining observation diagrams of the lungs of mice in the blank group, model group, Example 1 (low), Example 1 (medium), and Example 1 (high) groups respectively. It can be seen from the figure that a large number of inflammatory cells infiltrate in the lungs of ARDS mice, the alveolar structure is widely damaged, and the alveolar capillaries are congested and dilated. Taking the traditional Chinese medicine granules provided by the present invention has an obvious improvement effect on the lung injury of mice.

[0060]

[0061] Note: Compared with the blank group, # P<0.05, ## P<0.01; compared with the model group, * P<0.05, ** P<0.01; compared with the high-dose group of Example 1, ∆ P<0.05, ∆∆ P<0.01 (n = 10).

[0062] As shown in Table 4, compared with the blank group, the pathological score of the lung tissue of mice in the model group increased significantly, indicating that the model was successfully established; compared with the mice in the model group, the pathological scores of the lung tissues of mice in the Example 1 (low), Example 1 (medium), Example 1 (high), and Comparative Example 1-7 groups all decreased significantly, indicating that administering the above traditional Chinese medicine preparations to mice has a certain improvement effect on lung tissue injury; compared with the mice in the Example 1 (high) group, the pathological scores of the lung tissues of mice in the Comparative Example 1-7 groups were all higher, indicating that the traditional Chinese medicine granules provided by the present invention have a significantly better improvement effect on mouse lung injury than the traditional Chinese medicine granules provided in the comparative examples. Even if the monarch drug or adjuvant drug in the formula is replaced with common traditional Chinese medicine components or a part of the monarch drug or adjuvant drug is removed, it is difficult to achieve the same efficacy as the traditional Chinese medicine formula provided by the present invention, indicating that there is an obvious synergistic cooperation among the 15 traditional Chinese medicines provided by the present invention. While each formula exerts its own efficacy, they are mutually beneficial. All 15 traditional Chinese medicines must be present simultaneously to achieve the ideal effect of improving mouse lung tissue injury.

[0063] 2. Clinical research 2.1 Clinical data Eighty ARDS patients hospitalized in the ICU of Jiamusi Traditional Chinese Medicine Hospital from June 2024 to December 2024 were selected. Using the stratified randomization method, they were divided into a conventional group and an experimental group at a ratio of 1:1. There were 40 cases in the experimental group, including 25 males and 15 females, with an average age of (55.2 ± 3.2) years. There were 40 cases in the conventional group, including 23 males and 17 females, with an average age of (53.7 ± 4.1) years. There was no statistically significant difference in the clinical data between the two groups (P > 0.05).

[0064] 2.2 Case selection criteria Inclusion criteria: (1) Meeting the diagnostic criteria for acute respiratory distress syndrome; (2) Having symptoms / signs such as chest pain, rapid breathing, and moist rales in the lungs. Exclusion criteria: (1) Those with severe immune system diseases; (2) Those with severe infections; (3) Those with combined severe abdominal organ and craniocerebral injuries.

[0065] 2.3 Treatment methods The conventional group was given conventional treatments (respiratory support, anti-infection, organ function protection, glucocorticoids, etc.). The experimental group was given the traditional Chinese medicine preparation made from the traditional Chinese medicine composition provided in Example 1 of the present invention while receiving conventional treatment. It was decocted orally according to the conventional method, twice a day, and continuously treated for 14 days.

[0066] 2.4 Efficacy evaluation criteria Cured: After treatment, the clinical symptoms of the patient completely disappeared, the auscultation of the lungs showed normal breath sounds, and the imaging examination showed clear lung markings. Markedly effective: After treatment, the patient had basically no symptoms, the auscultation of the lungs showed mild moist rales, and the imaging examination showed relatively thick and disordered lung markings. Effective: After treatment, the patient had mild symptoms, the auscultation of the lungs showed slight moist rales, and the imaging examination showed slightly thickened and disordered lung markings. Ineffective: After treatment, the patient's symptoms did not improve or worsened, the auscultation of the lungs showed no improvement or deterioration compared with before treatment, and the imaging examination showed no improvement or deterioration compared with before treatment. The total effective rate = cure rate + marked effective rate + effective rate.

[0067] 2.5 Statistical methods The SPSS 17.0 statistical software package was used to analyze and sort out the data. The chi-square test for count data was used for comparison between groups, and P < 0.05 was considered statistically significant.

[0068] 2.6 Research results Note: Compared with the conventional group, * P < 0.05.

[0069] It can be seen from Table 5 that the total effective rate of the conventional group was 70.0%, and the total effective rate of the experimental group was 90.0%. Moreover, the clinical efficacy of the experimental group was significantly better than that of the conventional group ( *P < 0.05), indicating that applying the traditional Chinese medicine composition provided by the present application to clinical practice and combining it with conventional treatment means has better effects on patients with acute respiratory distress syndrome.

[0070] In summary, in the present invention, ephedra, stemona root, and dwarf lilyturf tuber are used as the monarch drugs to disperse lung qi and relieve asthma, clear heat and promote fluid production; polygonum cuspidatum, chlorite-schist, and pinellia ternata are used as the minister drugs to clear heat and promote diuresis, reduce phlegm and calm the liver, and lower adverse qi and stop vomiting; astragalus membranaceus, atractylodes macrocephala, rehmannia glutinosa, and cornelian cherry are used as the assistant drugs to replenish middle qi, invigorate the spleen and dry dampness, and replenish essence and marrow; rhodiola rosea, motherwort, taxillus chinensis, and dipsacus asperoides are used as the envoy drugs to boost qi and activate blood circulation, dredge meridians and relieve asthma, and tonify the kidney and strengthen tendons. Coupled with licorice to harmonize all the drugs, the combination of deficiency and excess is achieved, and the heart, lung, liver, spleen, and kidney are treated simultaneously, ultimately achieving the effect of fully treating ARDS.

[0071] It should be noted that in this article, terms such as "including", "comprising", or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article, or device including a series of elements not only includes those elements but also includes other elements not explicitly listed, or elements inherent to such process, method, article, or device.

[0072] Although the embodiments of the present invention have been shown and described, for those of ordinary skill in the art, it can be understood that various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for treating acute respiratory distress syndrome, characterized in that, The traditional Chinese medicine composition is composed of the following raw medicinal materials: Ephedra sinica, Stemona japonica, Ophiopogon japonicus, Polygonum cuspidatum, Chlorite Schist, Pinellia ternata, Astragalus membranaceus, Atractylodes macrocephala, Rehmannia glutinosa, Cornus officinalis, Rhodiola rosea, Leonurus japonicus, Taxillus sutchuenensis, Dipsacus asperoides, Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition for treating acute respiratory distress syndrome according to claim 1, wherein, The traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: 20-25 parts of Ephedra sinica, 20-25 parts of Stemona japonica, 15-20 parts of Ophiopogon japonicus, 10-20 parts of Polygonum cuspidatum, 5-10 parts of Chlorite Schist, 10-20 parts of Pinellia ternata, 15-20 parts of Astragalus membranaceus, 10-15 parts of Atractylodes macrocephala, 15-20 parts of Rehmannia glutinosa, 10-15 parts of Cornus officinalis, 15-20 parts of Rhodiola rosea, 10-20 parts of Leonurus japonicus, 10-15 parts of Taxillus sutchuenensis, 10-15 parts of Dipsacus asperoides, 10-20 parts of Glycyrrhiza uralensis.

3. The traditional Chinese medicine composition for treating acute respiratory distress syndrome according to claim 1, wherein The traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: 20 parts of Ephedra sinica, 20 parts of Stemona japonica, 15 parts of Ophiopogon japonicus, 15 parts of Polygonum cuspidatum, 5 parts of Chlorite Schist, 15 parts of Pinellia ternata, 20 parts of Astragalus membranaceus, 15 parts of Atractylodes macrocephala, 15 parts of Rehmannia glutinosa, 10 parts of Cornus officinalis, 15 parts of Rhodiola rosea, 10 parts of Leonurus japonicus, 10 parts of Taxillus sutchuenensis, 10 parts of Dipsacus asperoides, 15 parts of Glycyrrhiza uralensis.

4. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a drug for treating acute respiratory distress syndrome.

5. The application according to claim 4, characterized in that The dosage form for preparing a drug for treating acute respiratory distress syndrome is an oral preparation, and the oral preparation is selected from any one of granules, tablets, capsules, powders, decoctions or pills.

6. A preparation method of a traditional Chinese medicine preparation for treating acute respiratory distress syndrome, characterized in that, It includes the following steps: S1. Weigh the processed products of the traditional Chinese medicine composition provided in any one of claims 2-3 according to the formula dosage, and then decoct with water 5-20 times the total weight of the above traditional Chinese medicine composition for three times to obtain a traditional Chinese medicine decoction. S2. Combine, filter and concentrate the traditional Chinese medicine decoction obtained from the three decoctions in step S1 to a relative density of 1.05-1.10 to obtain a traditional Chinese medicine extract. S3. Add clinically acceptable excipients to the traditional Chinese medicine extract obtained in step S2, and carry out preparation by a conventional preparation method to prepare any one of clinically acceptable granules, tablets, capsules, powders, decoctions or pills.

7. The preparation method of the traditional Chinese medicine composition for treating acute respiratory distress syndrome according to claim 6, wherein, When preparing granules, step S3 specifically includes: Step S31. Add dextrin accounting for 3-7% of the total weight of the traditional Chinese medicine composition to the traditional Chinese medicine extract obtained in step S2, and spray dry to obtain a spray-dried powder. Step S32. Add dextrin accounting for 15-20% of the total weight of the granules to be prepared to the dried powder obtained in step S31 and mix evenly to prepare the final granules.

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