Traditional Chinese medicine composition for treating acute lung injury as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating acute lung injury and a preparation method and application thereof. The traditional Chinese medicine composition for treating the acute lung injury is prepared from the following raw materials in parts by weight: 10 to 15 parts of cortex moutan, 15 to 25 parts of radix paeoniae rubra, 25 to 35 parts of radix rehmanniae recen, 10 to 20 parts of semen persicae, 10 to 20 parts of fructus aurantii immaturus, 10 to 15 parts of radix curcumae, 10 to 15 parts of rhizoma acori graminei, 15 to 25 parts of fructus trichosanthis, 10 to 20 parts of fructus forsythiae, 10 to 20 parts of rhizoma polygoni cuspidati, 15 to 25 parts of semen lepidii and 25 to 35 parts of radix astragali seu hedysari. The traditional Chinese medicine composition has the beneficial effects that the traditional Chinese medicine composition for treating the acute lung injury can play a role in the aspects of improving the immune state, improving circulation and the like by influencing the release of inflammatory factors; the traditional Chinese medicine composition can improve the treatment effective rate and off-line success rate of acute lung injury patients, shorten the mechanical ventilation time, improve the oxygenation index of the patients, reduce the expression of proinflammatory factors IL-6, regulate the immune balance of Th1 / Th2 and Th17 / Treg, improve hemagglutination and relieve the disease severity and multi-organ dysfunction of the patients.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating acute lung injury, its preparation method, and its application. Background Technology

[0002] Acute lung injury (ALI) and its severe form, acute respiratory distress syndrome (ARDS), are common critical illnesses in intensive care units. They are characterized by refractory hypoxemia, decreased lung compliance, and diffuse bilateral pulmonary infiltration, exhibiting high morbidity and mortality (30-50%). The causes are complex and diverse, commonly including severe infections (sepsis), trauma, shock, aspiration, pancreatitis, and severe burns. These causes trigger an inflammatory cytokine storm, leading to pathological changes such as alveolar-capillary barrier disruption, pulmonary edema, hyaline membrane formation, and microthrombus formation. Western medicine treatment for ALI remains primarily etiological and supportive care, with limited effectiveness. Currently, there are no approved drugs specifically targeting inflammation or ALI. Summary of the Invention

[0003] This application provides a traditional Chinese medicine composition for treating acute lung injury, its preparation method, and its application, aiming to solve the problems of low cure rate, lack of effective drugs to reduce inflammation, high mortality rate, and high treatment cost in the prior art for acute lung injury.

[0004] This application provides a traditional Chinese medicine composition for treating acute lung injury, comprising the following raw materials in parts by weight: 10-15 parts of peony bark, 15-25 parts of red peony root, 25-35 parts of rehmannia root, 10-20 parts of peach kernel, 10-20 parts of immature bitter orange, 10-15 parts of turmeric, 10-15 parts of acorus tatarinowii rhizome, 15-25 parts of trichosanthes fruit, 10-20 parts of forsythia fruit, 10-20 parts of polygonum cuspidatum root, 15-25 parts of lepidium seed, and 25-35 parts of astragalus root.

[0005] Moutan bark, also known as peony bark, is the dried root bark of the peony plant (Paeonia suffruticosa), belonging to the Ranunculaceae family. It mainly contains chemical components such as paeonol, and has hepatoprotective, kidney-protective, anti-inflammatory, sedative, antipyretic, and analgesic effects.

[0006] Red peony root is the dried root of Paeonia lactiflora or Paeonia veitchii, both belonging to the Ranunculaceae family. It has the effects of clearing heat and cooling blood, promoting blood circulation and removing blood stasis.

[0007] Rehmannia glutinosa is the dried root of Rehmannia glutinosa, a plant in the Scrophulariaceae family. It has the effects of clearing heat and cooling blood, nourishing yin and promoting body fluids, moisturizing dryness and improving cardiovascular and cerebrovascular health.

[0008] Peach kernels are the dried, mature seeds of peach or wild peach plants, belonging to the Rosaceae family. They have the effects of promoting blood circulation, removing blood stasis, moistening the intestines and relieving constipation, and relieving cough and asthma.

[0009] Citrus aurantium is the dried young fruit of Citrus aurantium or Citrus tangerine, a plant in the Rutaceae family. It has the effects of breaking up qi stagnation, eliminating phlegm, and dispersing lumps.

[0010] The medicinal part of turmeric is the dried tuberous root of the plant, which has the effects of promoting blood circulation and relieving pain, regulating qi and relieving depression, clearing the heart and cooling the blood, and promoting bile secretion and reducing jaundice.

[0011] Sweet flag (Acorus calamus) is a perennial herb belonging to the Araceae family and the Acorus genus. It has the effects of strengthening the stomach and aiding digestion, as well as improving intelligence and refreshing the mind.

[0012] The whole Trichosanthes fruit is the dried, mature fruit of Trichosanthes kirilowii or Trichosanthes spp., belonging to the Cucurbitaceae family. It is effective in treating mastitis and ulceration.

[0013] Forsythia has the effects of clearing heat and detoxifying, reducing swelling and dissipating nodules. It is one of the traditional Chinese medicines commonly used in clinical practice in China and is often used to treat symptoms such as acute wind-heat cold and lymph node tuberculosis.

[0014] Polygonum cuspidatum is the dried rhizome and root of the Polygonum cuspidatum plant, which has the effects of promoting diuresis and relieving jaundice, clearing heat and detoxifying, dispersing blood stasis and relieving pain, and relieving cough and resolving phlegm.

[0015] Lepidium seed is the seed of Lepidium apetalum, Lepidium lyratum, or Artemisia scoparia. It has the effects of purging lung heat and lowering qi, eliminating phlegm and relieving asthma, promoting diuresis and reducing swelling, and clearing heat and expelling pathogens.

[0016] Astragalus is a plant belonging to the genus Astragalus in the legume family. It has the effects of tonifying qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, generating fluids and nourishing blood, promoting blood circulation and relieving pain, promoting detoxification and draining pus, and promoting wound healing and tissue regeneration.

[0017] According to some embodiments of the traditional Chinese medicine composition for treating acute lung injury described in this application, the raw materials include the following parts by weight: 12-14 parts of peony bark, 18-22 parts of red peony root, 28-32 parts of rehmannia root, 12-18 parts of peach kernel, 12-18 parts of immature bitter orange, 12-14 parts of turmeric, 12-14 parts of acorus tatarinowii rhizome, 18-22 parts of trichosanthes fruit, 12-18 parts of forsythia fruit, 12-18 parts of polygonum cuspidatum, 18-22 parts of lepidium seed, and 28-32 parts of astragalus root.

[0018] According to some embodiments of the traditional Chinese medicine composition for treating acute lung injury described in this application, the raw materials include the following parts by weight: 12 parts of peony bark, 20 parts of red peony root, 30 parts of rehmannia root, 15 parts of peach kernel, 15 parts of immature bitter orange, 12 parts of turmeric, 12 parts of acorus tatarinowii rhizome, 20 parts of trichosanthes fruit, 15 parts of forsythia fruit, 15 parts of polygonum cuspidatum, 20 parts of lepidium seed, and 30 parts of astragalus root.

[0019] According to some embodiments of the traditional Chinese medicine composition for treating acute lung injury described in this application, the traditional Chinese medicine composition further includes 25-35 parts of gypsum, such as 25 parts, 28 parts, 30 parts, 32 parts, 35 parts, etc. Gypsum can be added to the prescription when the patient with acute lung injury has high fever symptoms.

[0020] According to some embodiments of the traditional Chinese medicine composition for treating acute lung injury described in this application, the traditional Chinese medicine composition further includes 4-8 parts of raw ephedra, such as 4 parts, 5 parts, 6 parts, 8 parts, etc. When patients with acute lung injury also have shortness of breath, raw ephedra can be added to the prescription.

[0021] According to some embodiments of the traditional Chinese medicine composition for treating acute lung injury described in this application, the traditional Chinese medicine composition further includes 10-20 parts of ginseng, such as 10 parts, 12 parts, 15 parts, 18 parts, 20 parts, etc. When patients with acute lung injury also have symptoms of excessive sweating, ginseng can be added to the prescription.

[0022] The second aspect of this application provides a method for preparing the traditional Chinese medicine composition for treating acute lung injury as described in the first aspect of this application, comprising the following steps: (1) The above raw materials were boiled in water to extract the extract; (2) Combine the extracts, filter and concentrate to obtain the concentrate; (3) Mix the concentrate with ethanol, let it stand and take the supernatant, filter the supernatant and concentrate it to obtain the traditional Chinese medicine composition.

[0023] According to some embodiments of the preparation method of the traditional Chinese medicine composition for treating acute lung injury described in this application, the ratio of water to the mass of each raw material in the decoction is (10-12):1.

[0024] According to some embodiments of the preparation method of the traditional Chinese medicine composition for treating acute lung injury described in this application, the decoction temperature is 90-100℃, such as 90℃, 93℃, 95℃, 98℃, 100℃, etc., and the decoction time is 30-60min, such as 30min, 35min, 40min, 45min, 50min, 60min, etc.

[0025] According to some embodiments of the preparation method of the traditional Chinese medicine composition for treating acute lung injury described in this application, the amount of ethanol used is greater than or equal to the amount of the concentrate used.

[0026] According to some embodiments of the preparation method of the traditional Chinese medicine composition for treating acute lung injury described in this application, the preparation method further includes adding sucrose and dextrin to the concentrate obtained in step (3) to obtain a mixture, and subjecting the mixture to a process of softening, granulation, drying and sizing in sequence to obtain the traditional Chinese medicine composition.

[0027] According to some embodiments of the preparation method of the traditional Chinese medicine composition for treating acute lung injury described in this application, the drying temperature is 40-60℃ and the drying time is 1-2 hours.

[0028] The third aspect of this application provides the use of the traditional Chinese medicine composition for treating acute lung injury described in the first aspect of this application or the traditional Chinese medicine composition for treating acute lung injury obtained by the preparation method described in the second aspect of this application in the preparation of a drug for treating acute lung injury.

[0029] According to some embodiments of the application described in this application, the acute lung injury is acute lung injury caused by sepsis.

[0030] The beneficial effects of this application include: the traditional Chinese medicine composition for treating acute lung injury described in this application can exert its effects by influencing the release of inflammatory factors, improving immune status, improving circulation, and protecting vascular endothelium.

[0031] The traditional Chinese medicine composition for treating acute lung injury described in this application contains turmeric, peach kernel, peony bark, red peony root, and polygonum cuspidatum, all of which have the functions of promoting blood circulation, removing blood stasis, clearing heat, and purging the bowels, allowing the pathogenic heat and stagnation to have an outlet. Patients with acute lung injury often present with shortness of breath, weak cough, and clouded consciousness. The pathological changes are mainly non-cardiac pulmonary edema. The formula includes acorus tatarinowii to resolve phlegm, dispel dampness, and open the orifices, which, when combined with turmeric and trichosanthes fruit, treats phlegm-heat obstruction and delirium. Astragalus membranaceus tonifies qi and promotes diuresis. Astragalus membranaceus and lepidium apetalum are a pair of herbs for clearing phlegm. Because patients with sepsis have already been treated with antibiotics, the formula uses polygonum cuspidatum and forsythia to clear heat and detoxify. This formula, by cooling the blood, prevents the heat in the blood from scorching the body fluids and causing blood stasis. By dispersing blood stasis, it prevents the heat toxin from attaching to the blood and from becoming difficult to clear by binding with the blood stasis.

[0032] The traditional Chinese medicine composition for treating acute lung injury described in this application can improve the treatment efficacy and weaning success rate of patients with acute lung injury, shorten the mechanical ventilation time, improve the patient's oxygenation index, reduce the expression of pro-inflammatory factor IL-6, regulate the immune balance of Th1 / Th2 and Th17 / Treg, improve blood coagulation, and alleviate the severity of the patient's condition and multiple organ dysfunction. Attached Figure Description

[0033] Figure 1 This is a network diagram of the effective components-gene targets of the traditional Chinese medicine composition for treating acute lung injury described in Example 1 of this application. Figure 2 This is a Venn diagram of the target gene of the traditional Chinese medicine composition for treating acute lung injury described in Example 1 of this application – the acute lung injury gene. Detailed Implementation

[0034] The embodiments of the present invention are described in detail below. These embodiments are exemplary and intended to explain the present invention, and should not be construed as limiting the present invention.

[0035] In this invention, the terms "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., refer to a specific feature, structure, material, or characteristic described in connection with that embodiment or example, which is included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0036] Example 1 A traditional Chinese medicine composition for treating acute lung injury comprises the following ingredients in parts by weight: 10g of peony bark, 15g of red peony root, 25g of rehmannia root, 10g of peach kernel, 10g of immature bitter orange, 10g of turmeric, 10g of acorus tatarinowii rhizome, 15g of trichosanthes fruit, 10g of forsythia fruit, 10g of polygonum cuspidatum rhizome, 15g of lepidium seed, and 25g of astragalus root.

[0037] The preparation method of the traditional Chinese medicine composition for treating acute lung injury described in Example 1 includes the following steps: (1) The above raw materials were extracted by boiling them in water. The ratio of water to raw material mass was 10:1. The boiling temperature was controlled at 95℃. The extract was obtained by boiling at this temperature for 45 minutes. (2) Combine the extracts, filter and concentrate to obtain the concentrate; (3) Mix the concentrate with an equal mass of ethanol and stir until homogeneous. Let stand and take the supernatant. Filter the supernatant and concentrate to obtain the traditional Chinese medicine composition.

[0038] Example 2 The only difference between the traditional Chinese medicine composition described in Example 2 and that in Example 1 is that the weight proportions of each raw material contained in the traditional Chinese medicine composition described in Example 2 are different from those in Example 1.

[0039] The traditional Chinese medicine composition for treating acute lung injury described in Example 2 comprises the following raw materials in parts by weight: 12g of peony bark, 18g of red peony root, 28g of rehmannia root, 12g of peach kernel, 12g of immature bitter orange, 12g of turmeric, 12g of acorus tatarinowii rhizome, 18g of trichosanthes fruit, 12g of forsythia fruit, 12g of polygonum cuspidatum, 18g of lepidium seed, and 28g of astragalus root.

[0040] The preparation method of the traditional Chinese medicine composition for treating acute lung injury described in Example 2 includes the following steps: (1) The above raw materials were extracted by boiling them in water. The ratio of water to raw material mass was 10:1. The boiling temperature was controlled at 95℃. The extract was obtained by boiling at this temperature for 45 minutes. (2) Combine the extracts, filter and concentrate to obtain the concentrate; (3) Mix the concentrate with an equal mass of ethanol and stir until homogeneous. Let stand and take the supernatant. Filter the supernatant and concentrate to obtain the traditional Chinese medicine composition.

[0041] Example 3 The only difference between the traditional Chinese medicine composition described in Example 3 and that in Example 1 is that the concentrated material in the traditional Chinese medicine composition described in Example 3 has been granulated.

[0042] The specific operating steps include: Add sucrose and dextrin to the concentrate in step (3) of Example 1 and mix to obtain a mixture. The mixture is then subjected to softening, granulation, drying and sizing processes to obtain the traditional Chinese medicine composition. The drying temperature is 40°C and the drying time is 1 hour.

[0043] Comparative Example 1 The only difference between the traditional Chinese medicine composition for treating acute lung injury described in Comparative Example 1 and that in Example 1 is that the traditional Chinese medicine composition for treating acute lung injury described in Comparative Example 1 does not contain the raw materials turmeric, peach kernel, peony bark, red peony root, rehmannia root and polygonum cuspidatum. The rest of the operation is the same as in Example 1.

[0044] Comparative Example 2 The only difference between the traditional Chinese medicine composition for treating acute lung injury described in Comparative Example 2 and that in Example 1 is that the traditional Chinese medicine composition for treating acute lung injury described in Comparative Example 2 does not contain the raw materials Citrus aurantium, Acorus tatarinowii, Lepidium apetalum, Forsythia suspensa, and Trichosanthes kirilowii. The other operations are the same as in Example 1.

[0045] Comparative Example 3 The only difference between the traditional Chinese medicine composition for treating acute lung injury described in Comparative Example 3 and that in Example 1 is that the traditional Chinese medicine composition for treating acute lung injury described in Comparative Example 3 does not contain the raw materials Astragalus membranaceus and Rehmannia glutinosa, while the rest of the operation is the same as in Example 1.

[0046] Comparative Example 4 The only difference between the traditional Chinese medicine composition for treating acute lung injury described in Comparative Example 4 and that in Example 1 is that the traditional Chinese medicine composition for treating acute lung injury described in Comparative Example 4 does not contain the raw materials Astragalus membranaceus and Lepidium apetalum. All other operations are the same as in Example 1.

[0047] Comparative Example 5 The only difference between the traditional Chinese medicine composition for treating acute lung injury described in Comparative Example 5 and Example 1 is that the traditional Chinese medicine composition for treating acute lung injury described in Comparative Example 5 does not contain the raw materials Polygonum cuspidatum and Forsythia suspensa, while the rest of the operation is the same as in Example 1.

[0048] Comparative Example 6 The only difference between the traditional Chinese medicine composition for treating acute lung injury described in Comparative Example 6 and Example 1 is that the traditional Chinese medicine composition for treating acute lung injury described in Comparative Example 6 uses Danshen instead of Danpi, Chuanxiong instead of Chishao, Honghua instead of Taoren, Danggui instead of Shengdi, and does not contain Yujin. The rest of the operation is the same as in Example 1.

[0049] Comparative Example 7 The only difference between the traditional Chinese medicine composition for treating acute lung injury described in Comparative Example 7 and Example 1 is that the traditional Chinese medicine composition for treating acute lung injury described in Comparative Example 7 uses tangerine peel instead of immature bitter orange, pinellia instead of acorus tatarinowii, ephedra instead of lepidium seed, dandelion instead of forsythia, and fritillaria thunbergii instead of trichosanthes fruit. The rest of the operation is the same as in Example 1.

[0050] Comparative Example 8 The only difference between the traditional Chinese medicine composition for treating acute lung injury described in Comparative Example 8 and Example 1 is that the traditional Chinese medicine composition for treating acute lung injury described in Comparative Example 8 uses mulberry bark instead of lepidium seed and codonopsis instead of astragalus root. The rest of the operation is the same as in Example 1.

[0051] 1. A study on the overlap between the therapeutic targets and the disease targets of the traditional Chinese medicine compositions for treating acute lung injury described in Example 1 and Comparative Examples 1-8 of this application.

[0052] The traditional Chinese medicine composition for treating acute lung injury described in this application was retrieved for its chemical components using the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP). Screening was conducted based on oral bioavailability (OB) ≥ 30% and drug-likeness (DL) ≥ 0.18, initially obtaining the effective components of the traditional Chinese medicine. Since Rehmannia glutinosa was not included in TCMSP, its active components were obtained through searches of the tcm-taiwan database, chemical databases, and literature. Screening was performed using the SwissADME platform with the following criteria: "GI absorption" = "HIGH"; and "Druglikeness" = "YES" for any two criteria. The effective components of 12 traditional Chinese medicines were obtained, as shown in Table 1.

[0053] Table 1 The effective components of the 12 traditional Chinese medicines obtained were uniformly imported into Swisstargetprediction for target prediction, and targets with probability > 0 were selected. Results: Based on oral bioavailability and drug-like properties, 29 components of Paeonia lactiflora, 11 components of Trichosanthes kirilowii, 10 components of Polygonum cuspidatum, 20 components of Astragalus membranaceus, 23 components of Forsythia suspensa, 11 components of Paeonia suffruticosa, 4 components of Acorus tatarinowii, 23 components of Prunus persica, 12 components of Lepidium apetalum, 15 components of Curcuma longa, and 22 components of Citrus aurantium were initially obtained. Components of Rehmannia glutinosa were screened and uploaded to SwissADME for further screening, initially obtaining 24 components. All components were uploaded to Swisstargetprediction for target prediction. A total of 6 components from Paeonia lactiflora, 3 from Trichosanthes kirilowii, 7 from Polygonum cuspidatum, 13 from Astragalus membranaceus, 10 from Forsythia suspensa, 4 from Paeonia suffruticosa, 24 from Rehmannia glutinosa, 3 from Acorus tatarinowii, 18 from Prunus persica, 4 from Lepidium apetalum, 6 from Curcuma longa, and 17 from Citrus aurantium were successfully predicted. After summarizing and removing duplicates, a total of 100 active ingredients and 902 target sites were obtained. The data was imported into Cytoscape 3.8.2 to construct a network diagram of "Traditional Chinese Medicine Composition - Active Ingredients - Gene Targets", as shown below. Figure 1 As shown.

[0054] Acute lung injury targets were obtained from Genecards, OMIM, and DisgNet, and gene names were standardized and supplemented in the Uniprot database, resulting in 1111 disease targets. The intersection of the targets of the active ingredients in the screened traditional Chinese medicine compositions with the targets of acute lung injury was plotted using a Venn diagram, revealing 185 common targets. Figure 2 As shown.

[0055] The chemical components of the traditional Chinese medicine (TCM) compositions described in Comparative Examples 1-8 were retrieved using the TCMSP (Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform). Screening was conducted based on oral bioavailability (OB) ≥ 30% and drug-likeness (DL) ≥ 0.18 to preliminarily obtain the effective components of the TCMs. For drugs not included in TCMSP, their active ingredients were obtained through searches of the tcm-taiwan database, chemical databases, and literature. These were then screened using the SwissADME platform with the following criteria: "GI absorption" = "HIGH"; and "Druglikeness" = "YES" for any two criteria. The obtained effective components were then imported into Swisstargetprediction for target prediction, selecting targets with a probability > 0. After summarizing and removing duplicates, the effective components and targets of each TCM composition were obtained. Acute lung injury targets were obtained from Genecards, OMIM, and Disgnet, and gene names were standardized and supplemented in the Uniprot database, resulting in a total of 1111 disease targets. The intersection of the targets of the active ingredients of each screened traditional Chinese medicine composition with the disease targets of acute lung injury was calculated, and the number and ratio of overlapping targets are shown in Table 2.

[0056] Table 2 As can be seen from Table 2, the overlap between the target gene of the effective component of the traditional Chinese medicine composition in Example 1 and the gene of acute lung injury is higher than that of the traditional Chinese medicine compositions in Comparative Examples 1-8, indicating that the traditional Chinese medicine composition in Example 1 can exert its pharmacological effect on acute lung injury through more targets.

[0057] The core targets of the traditional Chinese medicine composition for treating acute lung injury described in this application are GSK3B, SRC, and EGFR. GSK3B (glycogen synthase kinase-3β) plays a crucial role in regulating inflammation and coagulation. GSK3B exacerbates disease progression by regulating the expression of pro-inflammatory factors; it also plays a role in thrombus formation by regulating platelet function and coagulation factors. After vascular injury, GSK3B can regulate the coagulation cascade by affecting endothelial cell phosphorylation. SRC family kinases can activate procoagulation factors, thereby promoting the coagulation process. In acute lung injury, SRC promotes bidirectional regulation of coagulation and inflammation by enhancing platelet aggregation and the expression of pro-inflammatory mediators. EGFR activation and the TNFR1 signaling pathway play a key role in acute lung injury (ALI), especially in promoting endothelial cell inflammation and necrosis. In cytokine storms, abnormal activation of the EGFR signaling pathway can lead to systemic coagulation disorders, mainly by damaging endothelial cells, promoting the release of coagulation factors, and thrombus formation.

[0058] 2. Research on the traditional Chinese medicine composition for treating acute lung injury described in Example 1 and Comparative Examples 1-8 of this application in the treatment of acute lung injury.

[0059] 2.1 Research on the effects of the traditional Chinese medicine composition for treating acute lung injury in eliminating inflammation and improving symptoms. Similarity screening: Cases with a similarity of <0.7 between the traditional Chinese medicine composition of Comparative Examples 1-8 and the traditional Chinese medicine composition of the present invention were identified and assigned to Group A; cases with a similarity of ≥0.7 between the traditional Chinese medicine composition of Comparative Examples 1-8 were assigned to Group B, and the symptom-efficacy of the two groups were evaluated.

[0060] Because the etiology of acute lung injury is complex and diverse, with sepsis being the primary cause and its pathological mechanism relatively clear, the subjects of the acute lung injury study described below are all patients with acute lung injury caused by sepsis. 270 patients with acute lung injury were randomly selected clinically and divided into 9 groups. The traditional Chinese medicine composition for treating acute lung injury described in Example 1 of this application and the traditional Chinese medicine compositions for treating acute lung injury described in Comparative Examples 1-8 were decocted separately with water (the amount of water used for decoction was 10 times the weight of the traditional Chinese medicine composition) at 95°C for 45 minutes, and 200 ml were extracted and filtered. The 9 groups of patients with acute lung injury respectively took the decoction of the traditional Chinese medicine composition described in Example 1 and Comparative Examples 1-8. One dose was taken daily, divided into two doses, morning and evening, warm. The treatment results before and after one week of medication are shown in Table 3.

[0061] Table 3 As shown in Table 3, cases with a similarity of ≥0.7 to the traditional Chinese medicine composition described in this invention have higher clinical efficacy rates. Furthermore, cases with a similarity of ≥0.95 have the highest clinical efficacy and significant efficacy rates, indicating that the traditional Chinese medicine composition with a high degree of similarity to this application is a more optimized prescription for treating acute lung injury, demonstrating significant clinical efficacy and research value.

[0062] 2.2 Research on the effects of the traditional Chinese medicine composition for treating acute lung injury described in Example 1 of this application on improving the success rate of patient weaning from mechanical ventilation, shortening the duration of mechanical ventilation, and improving blood coagulation, inflammatory factors, and T cells. Methods: A total of 95 patients meeting the inclusion criteria were randomly divided into three groups: Example 1 group (n=32), Comparative Example 1 group (n=30), and blank group (n=33). All three groups received routine treatment. In addition, Example 1 group and Comparative Example 1 group received the aforementioned traditional Chinese medicine combination (decoction method as described above) via nasogastric tube. Routine treatment included sepsis according to the SSC2021 treatment guidelines and acute lung injury according to the acute lung injury treatment guidelines formulated by the Chinese Medical Association's Critical Care Medicine Branch. In addition to routine treatment, Example 1 group and Comparative Example 1 group received the decoction of the combination of drugs from Example 1 and Comparative Example 1 via nasogastric tube 2 hours after enrollment, one dose daily, 100ml every 12 hours. The treatment course for both groups was 7 days. The effects on improving the success rate of weaning from mechanical ventilation, shortening the duration of mechanical ventilation, and improving blood coagulation, inflammatory factors, and T cells are shown in Tables 4, 5, 6, 7, 8, and 9, respectively.

[0063] Table 4 Comparison of oxygenation index before and after treatment in the three groups of patients Note: *Comparison between the same group and before treatment, P<0.05 As shown in Table 4, the oxygenation index of all three groups of patients improved after treatment compared to before treatment. Furthermore, the oxygenation index of Group 1 (Example 1) was significantly higher than that of Group 1 (Comparative Example 1) and the control group. This indicates that the traditional Chinese medicine composition in Group 1 (Example 1) can significantly improve the oxygenation index of patients with acute lung injury, achieving a therapeutic effect.

[0064] Table 5 Comparison of weaning success rates after treatment among the three groups of patients. As shown in Table 5, the weaning success rate of the Example 1 group was higher than that of the Comparative Example 1 group and the control group, and the difference was statistically significant. This indicates that the traditional Chinese medicine composition of the Example 1 group can significantly improve the weaning success rate of patients with acute lung injury.

[0065] Table 6 Comparison of mechanical ventilation time among the three groups of patients As shown in Table 6, the mechanical ventilation time in Example 1 group was shorter than that in Comparative Example 1 group and the control group, and the difference was statistically significant. This indicates that the traditional Chinese medicine composition in Example 1 group can significantly shorten the mechanical ventilation time in patients with acute lung injury.

[0066] Table 7 Comparison of coagulation function before and after treatment in the three groups of patients Note: *Comparison between the same group and before treatment, P<0.05 Table 7 shows that blood coagulation improved in all three groups after treatment compared to before treatment. Furthermore, the platelet count in Example 1 group was higher than that in Comparative Example 1 and the control group, while the D-dimer count was lower than that in Comparative Example 1 and the control group; all differences were statistically significant. Elevated D-dimer reflects microthrombus formation, leading to pulmonary vascular endothelial damage and exacerbating pulmonary edema and hypoxemia. Decreased platelet count can be used to evaluate coagulation dysfunction in sepsis, and its protective effect has been demonstrated in maintaining pulmonary vascular integrity in a lipopolysaccharide-induced acute respiratory distress syndrome model. The traditional Chinese medicine composition in Example 1 group has a positive effect on improving blood coagulation in patients with acute lung injury.

[0067] Table 8 Comparison of inflammatory factors before and after treatment in the three groups of patients Note: *Comparison between the same group and before treatment, P<0.05.

[0068] Table 8 shows that the levels of inflammatory factors in all three groups of patients improved after treatment compared to before treatment. Furthermore, the IL-6 level in Example 1 group was lower than that in Comparative Example 1 and the control group, while the IL-10 level was higher than that in Comparative Example 1 and the control group, with statistically significant differences. Elevated IL-6 levels are closely related to the risk and severity of acute lung injury, reflecting a more severe disease state. Intervention on IL-6 may help improve prognosis. IL-10 is a centrally acting anti-inflammatory cytokine that can block the production of inflammatory factors by myeloid cells, NK cells, and T cells, thus alleviating immune-mediated lung injury. The traditional Chinese medicine composition in Example 1 group can improve the cytokine storm and regulate the body's inflammatory response.

[0069] Table 9 Comparison of T-cell counts before and after treatment in the three groups of patients. Note: *Comparison between the same group and before treatment, P<0.05.

[0070] Table 9 shows that the lymphocyte levels in all three groups improved after treatment compared to before treatment. Furthermore, the levels of Th1, Th1 / Th2, Th17, and Th17 / Treg cells in Example 1 were lower than those in Comparative Example 1 and the control group, while the levels of Th2 and Treg cells were higher than those in Comparative Example 1 and the control group; all differences were statistically significant. The innate and adaptive immune systems successively participate in the immune response of sepsis patients. The adaptive immune system mainly involves T lymphocytes and B lymphocytes. Helper Th1 cells (Th1 cells) secrete pro-inflammatory factors such as IFN-γ and IL-2, exacerbating lung tissue inflammation in sepsis patients. Th2 cells secrete anti-inflammatory factors such as IL-4, inhibiting the Th1 response. An increased Th1 / Th2 ratio further aggravates lung tissue damage. Th17 / Treg cells are an important pair of pro-inflammatory / anti-inflammatory immune regulatory cells; an imbalance between the two has been confirmed in ARDS. Previous studies have shown that Th1 / Th2 immune homeostasis imbalance is a crucial factor in severe inflammatory responses, while recent research reveals that the Th17 cell subset exhibits significant potential in acute inflammatory cascades by specifically secreting pro-inflammatory factors such as IL-17A / F. This study shows that the traditional Chinese medicine composition in Example 1 can reduce the proportion of Th1 and Th17 cells, increase the proportion of Th2 and Treg cells, and restore the cellular balance of Th1 / Th2 and Th17 / Treg cells.

[0071] Although the above embodiments have been shown and described, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Any changes, modifications, substitutions and variations made to the above embodiments by those skilled in the art are within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating acute lung injury, characterized in that, The ingredients include the following parts by weight: 10-15 parts of peony bark, 15-25 parts of red peony root, 25-35 parts of rehmannia root, 10-20 parts of peach kernel, 10-20 parts of immature bitter orange, 10-15 parts of turmeric, 10-15 parts of acorus tatarinowii rhizome, 15-25 parts of trichosanthes fruit, 10-20 parts of forsythia fruit, 10-20 parts of polygonum cuspidatum rhizome, 15-25 parts of lepidium seed, and 25-35 parts of astragalus root.

2. The traditional Chinese medicine composition for treating acute lung injury according to claim 1, characterized in that, The ingredients include the following parts by weight: 12-14 parts of peony bark, 18-22 parts of red peony root, 28-32 parts of rehmannia root, 12-18 parts of peach kernel, 12-18 parts of immature bitter orange, 12-14 parts of turmeric, 12-14 parts of acorus tatarinowii rhizome, 18-22 parts of trichosanthes fruit, 12-18 parts of forsythia fruit, 12-18 parts of polygonum cuspidatum, 18-22 parts of lepidium seed, and 28-32 parts of astragalus root.

3. The traditional Chinese medicine composition for treating acute lung injury according to claim 1, characterized in that, The traditional Chinese medicine composition also includes 25-35 parts of gypsum.

4. The traditional Chinese medicine composition for treating acute lung injury according to claim 1, characterized in that, The traditional Chinese medicine composition also includes 4-8 parts of raw ephedra.

5. The traditional Chinese medicine composition for treating acute lung injury according to claim 1, characterized in that, The traditional Chinese medicine composition also includes 10-20 parts of ginseng.

6. A method for preparing the traditional Chinese medicine composition for treating acute lung injury according to any one of claims 1-5, characterized in that, Includes the following steps: (1) The above raw materials were boiled in water to extract the extract; (2) Combine the extracts, filter and concentrate to obtain the concentrate; (3) Mix the concentrate with ethanol, let it stand and take the supernatant, filter the supernatant and concentrate it to obtain the traditional Chinese medicine composition.

7. The preparation method according to claim 6, characterized in that, In step (1), the ratio of water to the mass of each ingredient in the decoction is (10-12):1; And / or, the decocting temperature is 90-100℃, and the decocting time is 30-60 minutes.

8. The preparation method according to claim 6, characterized in that, In step (3), the amount of ethanol used is greater than or equal to the amount of the concentrate used.

9. The preparation method according to claim 6, characterized in that, The preparation method further includes adding sucrose and dextrin to the concentrate obtained in step (3) to obtain a mixture, and subjecting the mixture to a process of softening, granulation, drying and sizing in sequence to obtain the traditional Chinese medicine composition; Preferably, the drying temperature is 40-60℃ and the drying time is 1-2 hours.

10. The use of the traditional Chinese medicine composition for treating acute lung injury according to any one of claims 1-5 or the traditional Chinese medicine composition obtained by the preparation method according to any one of claims 6-9 in the preparation of a drug for treating or preventing acute lung injury; Preferably, the acute lung injury is acute lung injury caused by sepsis.

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