Application of Xinsunning capsule in preparation of medicine for treating septicopyemia caused by bacterial infection and concurrent bacterial myocarditis of septicopyemia caused by bacterial infection

Abstract

The invention discloses an application of a Xinsunning capsule in preparation of a medicine for treating septicopyemia caused by bacterial infection and concurrent bacterial myocarditis thereof, and belongs to the technical field of traditional Chinese medicine application. The Xinsuuning capsule can inhibit the growth of various bacteria in vitro, reduce the bacterial load in an animal body in a septicopyemia complicated with myocarditis mouse model caused by bacterial infection, improve the survival rate, reduce the concentration level of cardiac troponin I, interleukin 1 beta, tumor necrosis factor alpha and interleukin 6 in serum after bacterial infection, and improve the survival rate of the septicopyemia complicated with myocarditis mouse model. The traditional Chinese medicine composition can relieve myocarditis, and can improve septicopyemia caused by bacterial infection and organ injury caused by bacterial myocarditis. Therefore, the Xinsunning capsule can generate a remarkable treatment effect on septicopyemia and bacterial myocarditis caused by bacterial infection through multiple ways such as antibacterial action, immunoreaction regulation and myocardial injury alleviation, and a new scheme is provided for clinical treatment.

Description

Technical Field

[0001] The invention belongs to the technical field of application of traditional Chinese medicines, and particularly relates to the application of Xinsuning capsules in preparing medicines for treating sepsis caused by bacterial infection and its concurrent bacterial myocarditis. Background Art

[0002] Xinsuning Capsule is a compound Chinese herbal preparation consisting of Coptis chinensis, Pinellia ternata, Poria cocos, Citrus aurantium, Dichroa striata, Lotus seed core, Sophora flavescens, Artemisia annua, Ginseng, Ophiopogon japonicus, and Licorice root. It boasts a diverse composition, a wide distribution of target sites, and strong overall regulatory capabilities, demonstrating its efficacy in clearing heat and resolving phlegm, calming the heart, and relieving palpitations. It is primarily indicated for palpitations, chest tightness, restlessness, irritability, dry and bitter mouth, insomnia, dizziness, and irregular pulses caused by phlegm-heat disturbing the heart. It is suitable for patients with mild to moderate ventricular premature beats (symptoms include palpitations and chest tightness) caused by coronary heart disease and viral myocarditis.

[0003] Sepsis is a systemic inflammatory response triggered by bacterial infection, often an acute condition caused by bacterial invasion of the bloodstream. Pathogens, such as Staphylococcus aureus and Escherichia coli, can enter the body through the skin, respiratory tract, and other pathways. Once they breach the body's initial defenses, the toxic substances they produce trigger a series of inflammatory responses, leading to microcirculatory dysfunction and endothelial damage. Typical manifestations include persistent fever, shortness of breath, and confusion. Rapidly progressive disease may also result in multi-organ dysfunction. Sepsis can cause a variety of complications, among which bacterial myocarditis is a common and severe complication of sepsis. During the course of infection, bacteria may affect the heart through various mechanisms. First, some pathogens can directly invade the myocardium, triggering local inflammation and tissue damage. Second, systemic inflammation and the accompanying release of toxic factors may indirectly affect myocardial cell function, disrupting normal pumping activity. Furthermore, circulatory abnormalities caused by sepsis, such as blood pressure fluctuations and hypoperfusion, can further increase the workload on the heart, exacerbating myocardial damage. The pathogenesis of bacterial myocarditis is typically related to the dissemination of pathogens to the heart through the bloodstream, which can cause varying degrees of damage to the structural integrity and functional status of the myocardium, thereby inducing cardiac dysfunction. Patients with this condition often present with nonspecific symptoms such as fever, tachycardia, dyspnea, chest discomfort, and general fatigue. However, there are currently no reports of Xinsuning Capsules being effective in treating sepsis or sepsis-complicated bacterial myocarditis. Summary of the Invention

[0004] In order to overcome the shortcomings of the above-mentioned prior art, the object of the present invention is to provide the use of Xinsuning Capsules in the preparation of drugs for treating sepsis caused by bacterial infection and its concurrent bacterial myocarditis.

[0005] In order to achieve the above object, the present invention adopts the following technical solutions:

[0006] The first aspect of the present invention discloses the use of Xinsuning Capsules in the preparation of medicines for treating sepsis caused by bacterial infection and its concurrent bacterial myocarditis.

[0007] Preferably, the bacteria are one or more of Staphylococcus epidermidis ATCC 12228, Staphylococcus aureus ATCC 29213, Staphylococcus aureus ATCC 25923, methicillin-resistant Staphylococcus aureus ATCC 33591, Acinetobacter baumannii ATCC19606, Escherichia coli ATCC 25922 and Pseudomonas aeruginosa ATCC 27853.

[0008] Preferably, the drug for treating sepsis caused by bacterial infection and its concurrent bacterial myocarditis is a drug that inhibits bacterial growth.

[0009] Preferably, the drug for treating sepsis caused by bacterial infection and its concurrent bacterial myocarditis is a drug for reducing bacterial load.

[0010] Preferably, the drug for treating sepsis caused by bacterial infection and its concurrent bacterial myocarditis is a drug that reduces the level of inflammatory factors in serum.

[0011] More preferably, the inflammatory factors include IL-1β, TNF-α and IL-6.

[0012] Preferably, the drug for treating sepsis caused by bacterial infection and its concurrent bacterial myocarditis is a drug that reduces the concentration of cTnI, a marker of myocardial injury.

[0013] Preferably, the drug for treating sepsis caused by bacterial infection and its concurrent bacterial myocarditis is a drug that improves myocardial tissue morphology.

[0014] Further preferably, the myocardial tissue morphology includes the degree of myocardial cell inflammatory infiltration and the degree of myocardial cell fibrosis.

[0015] Preferably, the dosage of Xinsuning Capsule is 1.04 to 4.16 g / kg.

[0016] Compared with the prior art, the present invention has the following beneficial effects:

[0017] The application of the Xinsu Ning capsule provided by the present invention in the preparation of a drug for treating sepsis caused by bacterial infection and its concurrent bacterial myocarditis, through in vitro antibacterial activity determination and in vivo animal model experiments, systematically evaluated the therapeutic effect of the Xinsu Ning capsule in septic myocarditis disease. Experimental results show that the drug has a significant inhibitory effect on common pathogens such as Staphylococcus epidermidis, Staphylococcus aureus, methicillin-resistant Staphylococcus aureus, Acinetobacter baumannii, Escherichia coli and Pseudomonas aeruginosa, can effectively block bacterial growth, thereby playing the role of clearing the source of infection, and showing a broad-spectrum antibacterial effect in in vitro activity determination. By inducing septic reaction and concurrent bacterial myocarditis mouse model through bacterial infection, the effect of Su Ning capsule on treating bacterial infectious diseases in vivo was evaluated. Experimental results show that the sepsis score (MSS) of the mice in the treatment group is low, and the degree of systemic infection is alleviated. At the same time, the bacterial load in the heart tissue significantly decreases, indicating that the Xinsu Ning capsule can effectively inhibit the colonization and spread of pathogens in the target organ. The level of serum inflammatory factors was significantly lower than that of the model control group, indicating that the drug can slow down the systemic inflammatory response, alleviate local myocardial inflammation and secondary tissue damage. In addition, the expression of cardiac troponin I (cTnI), a marker of myocardial injury, was significantly downregulated in the Xinsu Ning capsule treatment group, indicating that the drug has an improving and protective effect on infection-related myocardial damage. In summary, Xinsu Ning capsule has multiple effects such as antibacterial effect, regulation of immune response and alleviation of myocardial damage, showing the efficacy of clearing organ bacteria, regulating inflammatory response and improving infection status. It has a significant therapeutic effect on sepsis and bacterial myocarditis caused by bacterial infection, indicating that it has application value in the treatment of sepsis and bacterial myocarditis caused by bacterial infection. The use of Xinsu Ning capsule to treat sepsis caused by bacterial infection and its concurrent bacterial myocarditis can solve the problem of bacterial resistance in antibiotic treatment and provide a new solution for the clinical treatment of bacterial sepsis and its concurrent bacterial myocarditis. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 The figure shows the results of in vitro antibacterial activity test of the Xinsuning capsule of the present invention against methicillin-sensitive Staphylococcus epidermidis (ATCC 12228);

[0019] Figure 2 The figure shows the results of in vitro antibacterial activity test of Xinsuning Capsule of the present invention against Staphylococcus aureus (ATCC 29213);

[0020] Figure 3 The figure shows the results of in vitro antibacterial activity test of Xinsuning Capsule of the present invention against Staphylococcus aureus (ATCC 25923);

[0021] Figure 4The figure shows the results of in vitro antibacterial activity test of the Xinsuning capsule of the present invention against methicillin-resistant Staphylococcus aureus (ATCC 33591);

[0022] Figure 5 1. The figure shows the results of in vitro antibacterial activity test of Xinsuning Capsule of the present invention against Acinetobacter baumannii (ATCC 19606);

[0023] Figure 6 The figure shows the results of in vitro antibacterial activity test of Xinsuning Capsule of the present invention against Escherichia coli (ATCC 25922);

[0024] Figure 7 The figure shows the results of in vitro antibacterial activity test of Xinsuning Capsule of the present invention against Pseudomonas aeruginosa (ATCC 27853);

[0025] Figure 8 This is a survival curve diagram of mice in the bacterial infection-induced sepsis and myocarditis model groups treated with different drugs or control solvents;

[0026] Figure 9 Statistical graph of cardiac bacterial load in mice of the bacterial infection-induced sepsis and myocarditis model groups treated with different drugs or control solvents;

[0027] Figure 10 This is a graph showing the cTnI concentration levels in the serum of mice in the bacterial infection-induced sepsis and myocarditis model groups after being treated with different drugs or a control solvent;

[0028] Figure 11 This is a graph showing the interleukin-1β (IL-1β) concentration levels in the serum of mice in the bacterial infection-induced sepsis and myocarditis model groups after being treated with different drugs or a control solvent;

[0029] Figure 12 This is a graph showing the concentration levels of tumor necrosis factor-α (TNF-α) in the serum of mice in the bacterial infection-induced sepsis and myocarditis model groups after being treated with different drugs or a control solvent;

[0030] Figure 13 This is a graph showing the serum interleukin-6 (IL-6) concentration levels of mice in the bacterial infection-induced sepsis and myocarditis model groups after being treated with different drugs or a control solvent;

[0031] Figure 14 The figures show the results of microscopic observation of pathological tissue sections of various organs (heart, liver, spleen, lung, and kidney) of mice with sepsis and myocarditis model caused by bacterial infection in the present invention after being treated with different drugs or control solvents and stained with hematoxylin and eosin (HE). DETAILED DESCRIPTION

[0032] To facilitate understanding of the features and effects of the present invention by those skilled in the art, the following provides a general description and definition of the terms and expressions used in the specification and claims. Unless otherwise indicated, all technical and scientific terms used herein have the ordinary meanings as understood by those skilled in the art regarding the present invention. In the event of conflict, the definitions in this specification shall prevail.

[0033] The theories or mechanisms described and disclosed herein, whether correct or incorrect, should not limit the scope of the present invention in any way, that is, the present invention can be implemented without being limited by any specific theory or mechanism.

[0034] Herein, all features such as values, amounts, amounts, and concentrations defined in numerical ranges or percentage ranges are for brevity and convenience only. Accordingly, the description of numerical ranges or percentage ranges should be considered to include and specifically disclose all possible subranges and individual values within the range (including integers and fractions).

[0035] In this document, unless otherwise specified, “include,” “including,” “contains,” “has” or similar terms cover the meanings of “consisting of” and “mainly consisting of,” for example, “A includes a” covers the meanings of “A includes a and other” and “A only includes a.”

[0036] In this document, for the sake of brevity, not all possible combinations of the various technical features in each embodiment or example are described. Therefore, as long as there are no contradictions in the combination of these technical features, the various technical features in each embodiment or example can be combined in any way, and all possible combinations should be considered to be within the scope of this specification.

[0037] Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiments are only used to illustrate the present invention and are not used in limiting the scope of the present invention.In addition, should be understood that after reading the content of the present invention description, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms fall equally within the scope limited by the application's appended claims.

[0038] The following examples utilize conventional instruments and equipment in the art. Experimental methods in the following examples, where specific conditions are not specified, were generally performed under conventional conditions or as recommended by the manufacturer. The various raw materials used in the following examples, unless otherwise specified, were conventional commercially available products, with specifications conventional in the art.

[0039] Example 1: In vitro activity assay against drug-resistant bacteria

[0040] The broth microdilution method was used to test the minimum inhibitory concentration (MIC) of Xinsuning Capsules (Batch No. 231002) and its main active ingredient berberine (purchased from Shanghai Yien Chemical Technology Co., Ltd., purity 95%) with moxifloxacin (purchased from Shanghai McLean Biochemical Technology Co., Ltd., purity 98%) as the positive control.

[0041] The experimental strains included Gram-positive bacteria: Staphylococcus epidermidis ATCC 12228, Staphylococcus aureus ATCC 29213, ATCC 25923, and methicillin-resistant Staphylococcus aureus ATCC 33591; and Gram-negative bacteria: Acinetobacter baumannii ATCC 19606, Escherichia coli ATCC 25922, and Pseudomonas aeruginosa ATCC 27853 (all strains used were from the American Type Culture Collection, ATCC).

[0042] The specific steps are as follows:

[0043] 1. Preparation of MHB medium: Weigh 20.0 g of MHB medium (purchased from Guangdong Huankai Biotechnology Co., Ltd.) and add it to 1 L of distilled water. Heat until completely dissolved, divide the mixture into conical flasks, and sterilize it by autoclaving at 121°C for 15 min.

[0044] 2. Cultivate the experimental strain to the logarithmic growth phase: Under sterile conditions, inoculate the experimental strain into 100 mL of MHB medium and culture in a 37°C constant temperature and humidity incubator for 20-22 hours.

[0045] 3. Sample Solution Preparation: Weigh the Xinsuning capsule sample and berberine standard to be tested and dissolve each in 1% dimethyl sulfoxide (DMSO) solution to prepare a Xinsuning capsule sample solution and a berberine sample solution with a concentration of 5120 μg / mL. Weigh the positive control and dissolve it in 1% DMSO solution to prepare a moxifloxacin sample solution with a concentration of 5120 μg / mL.

[0046] 4. Preparation of bacterial suspension: Under sterile conditions, culture the experimental strain to the logarithmic growth phase with MHB medium, calibrate it to a 0.5 McFarland unit turbidity standard, and then dilute it at a ratio of 1:200 for later use;

[0047] 5. Determination of MIC by micro-dilution method: The MIC was determined by micro-broth doubling dilution method in a sterile 96-well plate. 10 μL of moxifloxacin sample solution was added to the second well as a positive control, and 10 μL of Xinsuning capsule or berberine sample solution was added to the third and fourth wells respectively. After adding 10 μL of DMSO to the 4th to 10th wells in advance, 10 μL was continuously transferred to the next well in a two-fold decreasing manner starting from the 4th well. After thorough mixing, the solution was diluted to the 10th well, and 10 μL was discarded from the last well to keep the volume consistent. 10 μL of DMSO was added to the 11th well as a solvent control, and only culture medium was added to the 1st well as a blank control. Subsequently, 190 μL of diluted bacterial suspension was added to each well to make the final bacterial concentration 5×10 5 CFU / mL. The 96-well plate was incubated in a 37°C constant temperature and humidity chamber for 20-22 hours and the results were read.

[0048] 6. MIC endpoint interpretation: The concentration that can completely inhibit bacterial growth in a 96-well plate observed by naked eye under a black background is the minimum inhibitory concentration of the sample for that type of bacteria.

[0049] 7. Experimental results: As shown in Table 1 and Figures 1 to 7 As shown in the figure, it can be seen from the MIC endpoint interpretation that berberine, the main active ingredient in Xinsuning Capsules, has a certain antibacterial effect against Gram-positive bacteria including Staphylococcus epidermidis ATCC12228, Staphylococcus aureus ATCC 29213, ATCC25923 and methicillin-resistant Staphylococcus aureus ATCC33591, and Gram-negative bacteria including Acinetobacter baumannii ATCC19606 and Pseudomonas aeruginosa ATCC27853. The antibacterial effect of Xinsuning Capsules is more obvious than that of the main active ingredient berberine. In addition, Xinsuning Capsules also show a strong antibacterial effect against Gram-negative bacteria Acinetobacter baumannii, and have the potential to be developed as a drug to inhibit Gram-negative bacteria.

[0050] Table 1 Minimum inhibitory concentration of the tested drugs (μg / mL)

[0051]

[0052] Example 2: Evaluation of the therapeutic effect of Xinsuning capsule on bacterial infection-induced sepsis and myocarditis model mice

[0053] 1. Model Establishment and Survival Rate Determination

[0054] 1.1 Grouping, modeling, and drug administration

[0055] Six-week-old female KM mice (purchased from Changsha Tianqin Biotechnology Co., Ltd.) were used to establish a mouse model of bacterial infection-induced sepsis complicated by bacterial myocarditis. Sixty mice were randomly divided into six groups of 10 mice each after one week of adaptive feeding. A blank control group (C); a model control group (M); a positive drug moxifloxacin low-dose (ML), medium-dose (MM), and high-dose (MH) control group (5, 10, and 20 mg / kg); and a Xinsuning capsule low-dose (XL), medium-dose (XM), and high-dose (XH) treatment group (1.04 g / kg, 2.08 g / kg, and 4.16 g / kg, clinically equivalent doses) were set up. Except for the blank control group, all other groups were infected with methicillin-resistant Staphylococcus aureus ATCC 33591 (0.1 mL, 1×10 8 CFU / mL) to induce bacterial infection leading to sepsis and myocarditis. Six hours after infection, mice in each group were given a single dose of the drug via intraperitoneal injection. Mice in the blank control and model control groups received only the same dose of saline.

[0056] 1.2 Survival rate determination and MSS score calculation

[0057] The mice's condition and survival rate were observed for 7 consecutive days, and a survival curve was drawn. During this period, seven indicators including appearance, autonomous consciousness, autonomous activity, response to stimulation, eye condition, respiratory rate and respiratory quality were evaluated and scored. The scores ranged from 0 to 4 from the best to the worst, and the sepsis condition of the mice was scored using MSS.

[0058] 2. Bacterial load detection, hematological examination and pathological analysis

[0059] 2.1 Grouping and Dosing

[0060] The model was re-established according to the method described in "1.1", and a blank control group (C); a model control group (M); a positive drug moxifloxacin medium (MM) and high-dose (MH) control group (10 and 20 mg / kg); and a Xinsuning capsule medium (XM) and high-dose (XH) treatment group (2.08 g / kg and 4.16 g / kg) were set up, with 6 mice in each group. The mice in the model control group and treatment group were infected with methicillin-resistant Staphylococcus aureus ATCC 33591 (0.1 mL, 1 × 10 8 CFU / mL) to establish a bacterial infection-induced sepsis and myocarditis model. Six hours later, each group of mice received a single dose of the drug via intraperitoneal injection. Mice in the blank control and model control groups received only the same dose of normal saline.

[0061] 2.2 Index detection and pathological analysis

[0062] Twenty-four hours after administration, blood was collected from the mice's orbital cavity and centrifuged to assess cTnI, IL-1β, TNF-α, and IL-6 levels in the supernatant. Two days after administration, all mice were sacrificed, and their hearts, livers, lungs, spleens, and kidneys were collected. The tissues were fixed in 4% paraformaldehyde, and pathological sections were prepared and stained with hematoxylin and eosin to examine organ histomorphological changes. Half of the heart tissue was aseptically ground, and the bacterial count (CFU / g) in the heart tissue was counted to assess the drug's ability to eliminate bacteria.

[0063] 3. Experimental Results

[0064] During both model establishment processes, mice in the blank control group were in good condition, moving freely, with shiny fur, and no deaths occurred within 7 days. In contrast, mice in the model control group showed obvious mental depression, erect hair, rapid breathing, reduced activity, persistently low body temperature, and restricted food and water intake. All died within 3 days of infection, consistent with the typical characteristics of clinical sepsis with rapid progression and high mortality. In addition, hematological examinations of mice in the model control group showed significantly elevated levels of inflammatory factors TNF-α, IL-1β, and IL-6 in their plasma, showing the typical characteristics of early sepsis with massive release of inflammatory factors and systemic inflammatory response syndrome. At the same time, the bacterial load in the heart tissue of the model mice increased significantly, accompanied by a significant increase in the concentration of cTnI, a specific marker of myocardial cell damage, confirming that the model mice were successfully established and exhibited a typical pathological state of sepsis complicated by myocarditis.

[0065] 3.1 Survival rate determination and MSS score results

[0066] The survival rate of mice in each group was statistically shown as follows Figure 8 As shown, compared with the model control group, the Xinsuning Capsule and moxifloxacin treatment groups significantly delayed the death of mice infected with septic myocarditis. Xinsuning Capsule treatment significantly improved the survival rate of mice with septic myocarditis in a dose-dependent manner. The high-dose group had a survival rate of 50%, which, while lower than the moxifloxacin group (80%), was still statistically significant compared to the control group. This may be attributed to the antibacterial and anti-inflammatory effects of Xinsuning Capsule, which help alleviate the systemic reactions triggered by infection.

[0067] Table 2 shows the MSS scores for each group of mice. Untreated, the model mice were severely injured, with erect hair, decreased voluntary awareness, significantly reduced voluntary activity, and irregular respiratory rates, with predominantly chest-abdominal breathing. Consequently, the model control group displayed a high score (20.80±0.29). In contrast, treatment with Xinsuning Capsules significantly improved the symptoms and physiological conditions of the mice, with a significant reduction in MSS scores (4.10±0.18 in the high-dose group). This result demonstrates the significant therapeutic efficacy of Xinsuning Capsules in the mouse model of sepsis, improving the survival of mice with septic myocarditis.

[0068] Table 2 Statistics of MSS scores in mice

[0069]

[0070] 3.2 Bacterial load test results

[0071] The bacterial load of the hearts of mice in each group was as follows Figure 9 As shown in the figure, compared with the model control group, the bacterial load in the hearts of mice treated with Xinsuning Capsules decreased. This may indicate that Xinsuning Capsules can effectively act on the site of infection and directly reduce the number of bacteria. Compared with the model control group, mice treated with low, medium, and high doses of Xinsuning Capsules showed a decreasing trend in bacterial load. In the low-dose group, although the load decreased, the improvement was limited compared with the model control group. In the medium-dose and high-dose groups, the bacterial load in the heart was significantly reduced, and there was a dose effect. In particular, in the high-dose group, the bacterial load decreased by approximately 4 orders of magnitude, close to the effect of the positive control drug moxifloxacin, indicating that Xinsuning Capsules achieves its antibacterial effect by directly inhibiting the growth of pathogenic microorganisms.

[0072] 3.3 Hematological examination results

[0073] The results of the detection of myocardial injury marker cTnI and inflammatory factors in plasma are as follows Figures 10 to 13 As shown in Figure 2, after treatment with Xinsuning Capsules, the concentration of cTnI in the plasma of mice with sepsis complicated by myocarditis decreased significantly, indicating that the drug has the effect of improving myocardial damage ( Figure 10 The levels of inflammatory factors IL-1β, TNF-α, and IL-6 in the treatment group were significantly lower than those in the model control group, confirming the effectiveness of Xinsuning Capsule in alleviating inflammation ( Figures 11 to 13 The changes in these biochemical markers provide molecular-level evidence for the anti-inflammatory and immunomodulatory effects of Xinsuning Capsules. The significant decrease in inflammatory factors suggests the efficacy of Xinsuning Capsules in regulating immune responses and alleviating cytokine storms.

[0074] 3.4 Pathological analysis results

[0075] The results of histopathological analysis by HE staining were as follows Figure 14 As shown, mice in the model control group showed significant damage to multiple organs, including the heart, liver, spleen, lungs, and kidneys. After treatment with a high dose of Xinsuning Capsules (4.16 g / kg), the degree of damage to all major organs was significantly alleviated, with the protective effect being most prominent in cardiac tissue. In cardiac tissue sections, the myocardial structure of mice in the treatment group was relatively intact, inflammatory cell infiltration was reduced, and myocardial fiber arrangement tended to be regular, suggesting that the drug has a certain protective effect on myocardial tissue. In liver tissue, the model group showed changes such as hepatocyte swelling, local necrosis, and inflammatory cell infiltration. However, these abnormalities were significantly alleviated after treatment with Xinsuning Capsules, indicating that the drug may, to some extent, inhibit the occurrence of distal inflammatory responses triggered by septic myocarditis. Observation of spleen sections revealed that mice in the model group showed significant immune cell proliferation and disordered lymphoid tissue structure, while the spleen lymphoid follicle structure in the treatment group was clearer and the cells were regularly arranged, indicating that Xinsuning Capsules helps maintain the tissue stability of immune organs. Lung tissue analysis revealed changes in the model group, including inflammatory cell infiltration, alveolar wall thickening, and interstitial edema. However, treatment with Xinsuning Capsules reduced lung lesions, improved alveolar structure, and reduced inflammatory cell infiltration. In renal tissue sections, the model group showed degeneration of renal tubular epithelial cells and inflammatory infiltration. However, treatment with Xinsuning Capsules restored the integrity of the glomerular and tubular structures, maintaining better tissue morphology.

[0076] In summary, Xinsuning Capsules demonstrated a clear therapeutic effect in bacterially infected septic myocarditis in mice by inhibiting pathogen growth, regulating inflammatory responses, and alleviating tissue damage. Experimental results showed that treatment with Xinsuning Capsules increased mouse survival, reduced cardiac bacterial load, downregulated serum inflammatory cytokine levels, and protected myocardial tissue structure. These findings provide preliminary evidence for the application of Xinsuning Capsules in septic myocarditis and experimental support for exploring its feasibility in the clinical treatment of bacterially infected sepsis and concomitant myocarditis.

[0077] The above content is only for explaining the technical idea of the present invention and cannot be used to limit the protection scope of the present invention. Any changes made on the basis of the technical solution in accordance with the technical idea proposed by the present invention shall fall within the protection scope of the claims of the present invention.

Claims

1. Application of Xinsuning Capsules in the preparation of drugs for treating sepsis caused by bacterial infection and its concurrent bacterial myocarditis.

2. The use according to claim 1, characterized in that The bacteria are one or more of Staphylococcus epidermidis ATCC 12228, Staphylococcus aureus ATCC 29213, Staphylococcus aureus ATCC 25923, methicillin-resistant Staphylococcus aureus ATCC 33591, Acinetobacter baumannii ATCC 19606, Escherichia coli ATCC 25922 and Pseudomonas aeruginosa ATCC 27853.

3. The use according to claim 1 or 2, characterized in that The medicine for treating sepsis caused by bacterial infection and its concurrent bacterial myocarditis is a medicine for inhibiting bacterial growth.

4. The use according to claim 1 or 2, characterized in that The drug for treating sepsis caused by bacterial infection and its concurrent bacterial myocarditis is a drug for reducing bacterial load.

5. The use according to claim 1 or 2, characterized in that: The medicine for treating sepsis caused by bacterial infection and its concurrent bacterial myocarditis is a medicine for reducing the level of inflammatory factors in serum.

6. The use according to claim 5, characterized in that The inflammatory factors include IL-1β, TNF-α and IL-6.

7. The use according to claim 1 or 2, characterized in that The drug for treating sepsis caused by bacterial infection and its concurrent bacterial myocarditis is a drug for reducing the concentration of cTnI, a myocardial injury marker.

8. The use according to claim 1 or 2, characterized in that The medicine for treating sepsis caused by bacterial infection and its concurrent bacterial myocarditis is a medicine for improving the morphology of myocardial tissue.

9. The use according to claim 8, characterized in that The myocardial tissue morphology includes the degree of myocardial cell inflammatory infiltration and the degree of myocardial cell fibrosis.

10. The use according to claim 1 or 2, characterized in that: The dosage of Xinsuning Capsules is 1.04 to 4.16 g / kg.

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