A traditional Chinese medicine composition, a preparation method thereof and application of the traditional Chinese medicine composition in preparation of a medicine for preventing and treating sepsis

Abstract

The application discloses a traditional Chinese medicine composition, a preparation method thereof and application of the traditional Chinese medicine composition in preparation of medicines for preventing and treating sepsis, and belongs to the technical field of traditional Chinese medicines. The composition is composed of the following raw materials in parts by weight: 5-20 parts of dried ginger, 10-80 parts of ginseng, 3-15 parts of rhubarb, 5-20 parts of coptis, 5-20 parts of pinellia, 5-20 parts of scutellaria, 10-70 parts of prepared rehmannia, 5-20 parts of magnolia officinalis, 5-20 parts of apricot kernel, 10-30 parts of pueraria, and 10-40 parts of alisma. The traditional Chinese medicine composition can obviously reduce the mortality of sepsis model mice, improve physiological and mental state, blood routine and inflammation indexes, and effectively improve the SOFA score of sepsis clinical patients, which shows that the traditional Chinese medicine composition has obvious protective effect on sepsis. The traditional Chinese medicine composition is safe and reliable, has definite curative effect, and enriches the treatment means of sepsis.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition, its preparation method, and its application in the preparation of drugs for the prevention and treatment of sepsis. Background Technology

[0002] Sepsis is a severe, systemic organ dysfunction syndrome caused by a serious infection. It is a critical condition with a high mortality rate. Current clinical treatment focuses on anti-infection therapy, fluid resuscitation, and organ support. However, the pathological process of sepsis is complex, often simultaneously causing multiple problems such as systemic microcirculatory disturbances, intestinal failure, and metabolic disorders. Existing therapies primarily target single aspects or symptoms, making it difficult to effectively correct the overall imbalance in the body's system.

[0003] Traditional Chinese medicine believes that the core pathogenesis of sepsis lies in the damage to the body's vital energy (Qi) caused by external pathogenic factors or internal toxins, leading to a systemic "Qi imbalance." Specifically, this manifests as a chain of pathological states involving the simultaneous dysfunction of the three Jiaos (upper, middle, and lower Jiao), including impaired lung Qi circulation, stagnation of spleen and stomach function in the middle Jiao, and dysfunction of Qi transformation in the lower Jiao. This, in turn, leads to abnormal metabolism of Qi, blood, and body fluids, resulting in the accumulation of various pathological products such as toxins, heat, phlegm, blood stasis, and deficiency, exacerbating the condition. Therefore, addressing the core pathogenesis of "Qi imbalance" in sepsis and holistically regulating the Qi function of the upper, middle, and lower Jiaos is considered crucial to halting the malignant progression of sepsis.

[0004] In existing TCM treatments for sepsis, regulating Qi is primarily represented by Banxia Xiexin Decoction, as seen in "A Study on the Treatment of Gastrointestinal Dysfunction with Banxia Xiexin Decoction in Sepsis, Kong Li et al." However, this formula focuses on regulating the Qi of the spleen and stomach in the middle Jiao, offering limited intervention for the pathological aspects of impaired Qi circulation in the upper Jiao (lung) and dysfunction of Qi transformation in the lower Jiao (kidney and bladder). Therefore, existing technologies lack a holistic regulatory treatment plan that can simultaneously regulate all three Jiaos. In light of this, there is an urgent need to develop a new TCM composition targeting the systemic Qi disorder characterized by "impaired circulation in the upper Jiao, disordered Qi in the middle Jiao, and obstruction in the lower Jiao," to comprehensively regulate the functions of the three Jiaos and provide a new TCM intervention strategy for the comprehensive treatment of sepsis. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine composition based on the theory of Qi movement and its ascending and descending, for the treatment of sepsis, in order to solve the above-mentioned problems.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: a traditional Chinese medicine composition, which is composed of the following raw materials in parts by weight: 5-20 parts dried ginger, 10-80 parts ginseng, 3-15 parts rhubarb, 5-20 parts coptis, 5-20 parts pinellia, 5-20 parts scutellaria, 10-70 parts prepared rehmannia, and 5-20 parts magnolia bark.

[0007] Another traditional Chinese medicine composition, based on the above-mentioned raw materials, also includes the following raw materials in parts by weight: 5-20 parts of almonds, 10-30 parts of kudzu root, and 10-40 parts of alisma.

[0008] The herbal composition of this invention is guided by the theory of Qi movement, and achieves a combined approach of attacking and tonifying, treating all three Jiaos by supporting the body's vital energy, eliminating pathogenic toxins, and regulating the Qi movement of the upper, middle, and lower Jiaos as a whole. It is particularly suitable for treating sepsis, a systemic Qi disorder characterized by "disordered upper Jiao circulation, disordered middle Jiao Qi movement, and obstructed lower Jiao Qi." Specifically, this composition works through the following mechanisms.

[0009] Strengthening the body's resistance and consolidating its foundation, warming the yang and replenishing qi: Ginseng in the formula greatly replenishes the original qi and consolidates the body's resistance, leading the entire formula to support the body's resistance; dried ginger warms the middle jiao, dispels cold, restores yang and unblocks the meridians, and together with ginseng, they work together to warm and replenish the original yang and help the body's resistance to restore the rise and fall of qi.

[0010] Promoting lung function and moistening the intestines, opening up the upper burner: Almonds promote lung function and moisten the intestines to relieve constipation, while kudzu root promotes yang and dispels pathogens, relieves muscle tension and clears heat. The two, one ascending and one descending, unblock the qi mechanism of the upper burner and the pathway of qi movement.

[0011] Regulating Qi and resolving phlegm, harmonizing the middle Jiao: Pinellia ternata dries dampness and resolves phlegm, relieves nausea and harmonizes the stomach, while Magnolia officinalis promotes Qi circulation, relieves fullness and relieves nausea. Together, they relieve stagnation of Qi in the middle Jiao and restore the pivotal function of the spleen and stomach.

[0012] It clears the bowels and eliminates turbidity, and dredges the lower burner: rhubarb clears heat and removes blood stasis, clears the bowels and eliminates toxins, and when combined with alisma to promote diuresis and eliminate dampness, it can dredge the stagnation in the lower burner and give the pathogens a way out.

[0013] Clearing heat and drying dampness, detoxifying and purging fire: Scutellaria baicalensis and Coptis chinensis clear heat and dry dampness, detoxify and purge fire, targeting the heat and toxic pathogens in the upper and middle jiao, clearing obstacles to the smooth flow of qi.

[0014] Nourishing Yin and moisturizing dryness, balancing Yin and Yang: Rehmannia glutinosa tonifies the kidneys and replenishes essence, nourishes Yin and blood. When combined with warming Yang herbs such as dried ginger, the whole formula warms Yang without being too dry or irritating, and tonifies without causing stagnation, thus achieving the effect of balancing Yin and Yang.

[0015] In summary, this formula combines the effects of bitter and pungent to promote downward movement, tonification and purgation, and elimination of pathogens in the three jiaos. Through multi-target and multi-link holistic regulation, it clears pathological products such as heat, toxins, phlegm, and blood stasis, corrects the disordered state of the body's qi mechanism, and restores the production and circulation of qi and blood, thereby achieving effective treatment for sepsis.

[0016] Furthermore, it is a preparation made from the following raw materials in the indicated weight ratios: 5-10 parts dried ginger, 40-80 parts ginseng, 5-10 parts rhubarb, 5-10 parts coptis, 10-20 parts pinellia, 10-20 parts scutellaria, 40-60 parts prepared rehmannia, 10-20 parts magnolia bark, 10-20 parts apricot kernel, 10-20 parts kudzu root, and 20-40 parts alisma. The above-mentioned proportions result in better efficacy.

[0017] As a preferred technical solution, it is composed of the following raw materials in parts by weight: 5 parts dried ginger, 10 parts ginseng, 3 parts rhubarb, 5 parts coptis, 5 parts pinellia, 5 parts scutellaria, 10 parts prepared rehmannia, 5 parts magnolia bark, 5 parts apricot kernel, 10 parts kudzu root, and 10 parts alisma.

[0018] As a preferred technical solution, the ingredients are composed of the following raw materials in parts by weight: 20 parts dried ginger, 80 parts ginseng, 15 parts rhubarb, 20 parts coptis, 20 parts pinellia, 20 parts scutellaria, 70 parts prepared rehmannia, 20 parts magnolia bark, 20 parts apricot kernel, 30 parts kudzu root, and 40 parts alisma. The above proportions are more effective.

[0019] As a preferred technical solution, it is composed of the following raw materials in parts by weight: 10 parts dried ginger, 60 parts ginseng, 6 parts rhubarb, 10 parts coptis, 15 parts pinellia, 10 parts scutellaria, 50 parts prepared rehmannia, 10 parts magnolia bark, 10 parts apricot kernel, 20 parts kudzu root, and 30 parts alisma.

[0020] As a preferred technical solution, it is composed of the following raw materials in parts by weight: 10 parts dried ginger, 50 parts ginseng, 6 parts rhubarb, 10 parts coptis, 15 parts pinellia, 10 parts scutellaria, 50 parts prepared rehmannia, and 10 parts magnolia bark.

[0021] The second objective of this invention is to provide traditional Chinese medicine granules, tablets, mixtures, decoctions, oral liquids, or oral freeze-dried powders prepared from the above-mentioned traditional Chinese medicine compositions.

[0022] A third objective of this invention is to provide a method for preparing the above-mentioned oral lyophilized powder, comprising the following steps:

[0023] (1) Weigh the medicinal materials / processed slices according to the weight parts, and first decoct rhubarb: soak rhubarb in water, add water and decoct, filter the decoction with gauze and combine the filtrates;

[0024] (2) Decoction of the remaining medicinal materials: Soak the remaining medicinal materials in 6-10 times their weight of water, bring to a boil over high heat, and simmer over low heat at least twice; filter the resulting liquid with gauze each time and combine the filtrates;

[0025] (3) Concentration of medicinal liquid: Mix the filtrates obtained in steps (1) and (2) and concentrate them under vacuum at 50-60℃ until each milliliter of concentrated liquid is equivalent to 0.7-1.0g of medicinal slices, thus obtaining the concentrated Chinese medicine liquid;

[0026] (4) Freeze-drying: The prepared Chinese medicine concentrate is placed into a vacuum freeze-drying device for freeze-drying to obtain freeze-dried powder.

[0027] As a preferred technical solution, in step (3), the simmering process is as follows: simmering for 5 minutes the first time, simmering for 30 minutes the second time, and simmering for 30 minutes the third time.

[0028] In step (4), the specific steps of freeze drying are as follows: a) Pre-freezing: Pre-freezing at -80℃ for 12-24 hours; b) Sublimation drying: Vacuuming at -80℃ for 48-72 hours; c) Desorption drying: Drying at 30℃ for 24-48 hours, and freeze drying is completed.

[0029] The fourth objective of this invention is to provide the application of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for the prevention and treatment of any one of sepsis, septic shock, and systemic inflammatory syndrome.

[0030] The application includes the disease categories of "Wenbing" (warm disease), "Heat-toxin syndrome" (heat-toxin syndrome), and "Jue Tuo syndrome" (collapse syndrome) in Traditional Chinese Medicine; the syndrome categories of "Qi Mechanism Disorders", "Heat-toxin Intensive Syndrome", "Heat Entering the Blood Levels", "Yangming Fu-Shi Syndrome", "Zheng Xu Xie Xun Syndrome", and "Acute Deficiency Syndrome" in Traditional Chinese Medicine; and the symptom categories of "Cold Extremities", "Persistent High Fever", "Rapid Breathing", "Delirium and Irritability", "Abdominal Distension and Hardness", "Constipation", and "Heat-Heat Drainage".

[0031] It may inhibit inflammatory damage, and suppress liver and lung damage caused by sepsis.

[0032] Compared with the prior art, the advantages of the present invention are as follows: the traditional Chinese medicine compound composition of the present invention can significantly reduce the mortality rate of model mice, improve their physiological and mental state, blood routine and inflammatory indicators; and can effectively improve the sequential organ function (SOFA) score of sepsis patients. This indicates that the traditional Chinese medicine composition of the present invention has a significant protective effect on sepsis patients. The traditional Chinese medicine composition provided by the present invention is safe, reliable and has a clear curative effect, enriching the treatment methods for sepsis. Attached Figure Description

[0033] Figure 1 The effects of different experimental groups on leukocytes, monocytes and neutrophils in Example 6;

[0034] Figure 2 The effects of different experimental groups on serum inflammatory factors IL-1β and IL-6 in Example 6;

[0035] Figure 3 The effect of different experimental groups on D-lactic acid in Example 6;

[0036] Figure 4 The effects of different experimental groups on liver function ALT, AST and LDH levels in Example 6;

[0037] Figure 5 HE staining results of lung tissue from different experimental groups in Example 6. Detailed Implementation

[0038] The invention will now be further described with reference to the accompanying drawings.

[0039] It is particularly important to note that similar substitutions and modifications made to this invention are obvious to those skilled in the art, and they are all considered to be included in this invention. Those skilled in the art will clearly be able to modify or appropriately alter and combine the methods and applications described herein without departing from the content, spirit, and scope of this invention to implement and apply the technology of this invention. Obviously, the described embodiments are only a part of the embodiments of this invention, and not all of them.

[0040] Unless otherwise specified, the experimental methods described in the following examples are conventional methods; the reagents and materials described are commercially available unless otherwise specified.

[0041] The parts mentioned in Examples 1-4 below all refer to parts by weight.

[0042] Example 1

[0043] A traditional Chinese medicine compound preparation for treating sepsis, which is made into a freeze-dried powder of traditional Chinese medicine compound according to the following proportions: 10 parts dried ginger, 60 parts ginseng, 6 parts rhubarb, 10 parts coptis, 15 parts pinellia, 10 parts scutellaria, 50 parts prepared rehmannia, 10 parts magnolia bark, 10 parts apricot kernel, 20 parts kudzu root, and 30 parts alisma.

[0044] The preparation method is as follows: (1) Rhubarb decoction: Rhubarb is soaked in water for 30 minutes, then water is added and decocted. The amount of water added is 15 times the weight of rhubarb. The decoction is decocted for 5 minutes, and the liquid is filtered with gauze and the filtrates are combined; (2) Decoction of other medicinal slices: The medicinal slices are soaked in 8 times the amount of water for 30 minutes, brought to a boil over high heat, and then decocted over low heat: the first decoction is 5 minutes, the second decoction is 30 minutes, and the third decoction is 30 minutes; the liquid obtained each time is filtered with gauze and the filtrates are combined; (3) Concentration of medicinal liquid: The filtrates obtained in steps (1) and (2) are mixed and concentrated under vacuum at 55°C until each milliliter of concentrated liquid is equivalent to 0.9g of medicinal slices, thus obtaining the Chinese medicine concentrate; (4) Freeze-drying: The prepared Chinese medicine concentrate is placed in a vacuum freeze-drying device for freeze-drying to obtain freeze-dried powder. The specific steps are as follows: a) Pre-freezing: Pre-freeze at -80℃ for 24 hours; b) Sublimation drying: Vacuum drying at -80℃ for 60 hours; c) Desorption drying: Dry at 30℃ for 36 hours. The freeze-drying is then complete, and the product is obtained.

[0045] Example 2

[0046] A traditional Chinese medicine compound preparation for treating sepsis, which is made into a freeze-dried powder of traditional Chinese medicine compound according to the following proportions: 10 parts dried ginger, 50 parts ginseng, 6 parts rhubarb, 10 parts coptis, 15 parts pinellia, 10 parts scutellaria, 50 parts prepared rehmannia, and 10 parts magnolia bark.

[0047] The preparation method is as follows: (1) Rhubarb decoction: Rhubarb is soaked in water for 30 minutes, then water is added and decocted. The amount of water added is 15 times the weight of rhubarb. The decoction is decocted for 5 minutes, and the liquid is filtered with gauze and the filtrate is combined; (2) Decoction of other medicinal slices: The medicinal slices are soaked in 8 times the amount of water for 30 minutes, brought to a boil over high heat, and then decocted over low heat: the first decoction is 5 minutes, the second decoction is 30 minutes, and the third decoction is 30 minutes; the liquid obtained each time is filtered with gauze and the filtrate is combined; (3) Concentration of medicinal liquid: The filtrates obtained in steps (1) and (2) are mixed and concentrated under vacuum at 55°C until each milliliter of concentrated liquid is equivalent to 1.0g of medicinal slices, thus obtaining the Chinese medicine concentrated liquid; (4) Freeze-drying: The prepared Chinese medicine concentrated liquid is placed in a vacuum freeze-drying device for freeze-drying to obtain freeze-dried powder. The specific steps are as follows: a) Pre-freezing: Pre-freeze at -80℃ for 12 hours; b) Sublimation drying: Vacuum drying at -80℃ for 48 hours; c) Desorption drying: Dry at 30℃ for 24 hours. The freeze-drying is then complete, and the product is obtained.

[0048] Example 3

[0049] A traditional Chinese medicine compound preparation for treating sepsis, prepared as a freeze-dried powder of traditional Chinese medicine compound according to the following proportions: 20 parts dried ginger, 80 parts ginseng, 15 parts rhubarb, 20 parts coptis, 20 parts pinellia, 20 parts scutellaria, 70 parts prepared rehmannia, 20 parts magnolia bark, 20 parts apricot kernel, 30 parts kudzu root, and 40 parts alisma.

[0050] The preparation method is as follows: (1) Rhubarb decoction: Rhubarb is soaked in water for 30 minutes, then water is added and decocted. The amount of water added is 15 times the weight of rhubarb. The decoction is decocted for 5 minutes, and the liquid is filtered with gauze and the filtrate is combined; (2) Decoction of other medicinal slices: The medicinal slices are soaked in 8 times the amount of water for 30 minutes, brought to a boil over high heat, and then decocted over low heat: the first decoction is 5 minutes, the second decoction is 30 minutes, and the third decoction is 30 minutes; the liquid obtained each time is filtered with gauze and the filtrate is combined; (3) Concentration of medicinal liquid: The filtrates obtained in steps (1) and (2) are mixed and concentrated under vacuum at 55°C until each milliliter of concentrated liquid is equivalent to 0.7g of medicinal slices, thus obtaining the Chinese medicine concentrate; (4) Freeze-drying: The prepared Chinese medicine concentrate is placed in a vacuum freeze-drying device for freeze-drying to obtain freeze-dried powder. The specific steps are as follows: a) Pre-freezing: Pre-freeze at -80℃ for 24 hours; b) Sublimation drying: Vacuum drying at -80℃ for 72 hours; c) Desorption drying: Dry at 30℃ for 48 hours. The freeze-drying is then complete, and the product is obtained.

[0051] Example 4

[0052] A traditional Chinese medicine compound preparation for treating sepsis, which is made into a freeze-dried powder of traditional Chinese medicine compound according to the following proportions: 5 parts dried ginger, 10 parts ginseng, 3 parts rhubarb, 5 parts coptis, 10 parts pinellia, 5 parts scutellaria, 10 parts prepared rehmannia, 5 parts magnolia bark, 5 parts apricot kernel, 10 parts kudzu root, and 10 parts alisma.

[0053] The preparation method is as follows: (1) Rhubarb decoction: Rhubarb is soaked in water for 30 minutes, then water is added and decocted. The amount of water added is 15 times the weight of rhubarb. The decoction is decocted for 5 minutes, and the liquid is filtered with gauze and the filtrates are combined; (2) Decoction of other medicinal slices: The medicinal slices are soaked in 8 times the amount of water for 30 minutes, brought to a boil over high heat, and then decocted over low heat: the first decoction is 5 minutes, the second decoction is 30 minutes, and the third decoction is 30 minutes; the liquid obtained each time is filtered with gauze and the filtrates are combined; (3) Concentration of medicinal liquid: The filtrates obtained in steps (1) and (2) are mixed and concentrated under vacuum at 55°C until each milliliter of concentrated liquid is equivalent to 0.9g of medicinal slices, thus obtaining the Chinese medicine concentrate; (4) Freeze-drying: The prepared Chinese medicine concentrate is placed in a vacuum freeze-drying device for freeze-drying to obtain freeze-dried powder. The specific steps are as follows: a) Pre-freezing: Pre-freeze at -80℃ for 24 hours; b) Sublimation drying: Vacuum drying at -80℃ for 48 hours; c) Desorption drying: Dry at 30℃ for 48 hours. The freeze-drying is then complete, and the product is obtained.

[0054] Example 5

[0055] 1.1 Laboratory Animals

[0056] SPF grade, male C57BL / 6J mice, 6-8 weeks old, weighing 20-22g, purchased from Chengdu Jicui Yaokang Biotechnology Co., Ltd., Production License No.: SCXK (Sichuan) 2020-034, Usage License No.: SYXK (Sichuan) 2020-230, and bred by dedicated personnel from the Analysis and Testing Center of West China School of Public Health, Sichuan University.

[0057] 1.2 Instruments, Consumables and Reagents

[0058] Instruments and consumables: 4°C / -20°C refrigerator, 0.01% analytical balance, electronic balance, Eppendorf pipette, vortex apparatus, ultrasonic instrument, infrared thermometer, desiccator, weighing spoon, weighing paper, centrifuge tubes, centrifuge tube rack, 1 ml syringe, No. 6 gavage needle.

[0059] Reagents: Lipopolysaccharide (LPS, Sigma-Aldrich, L2630), physiological saline, 75% alcohol.

[0060] 1.3 Animal grouping and establishment of a sepsis mouse model

[0061] Animal grouping: Mice were randomly divided into blank control group (blank group, 5 mice), model control group (model group, 30 mice), Banxia Xiexin Decoction control group (positive drug control group, 30 mice), Example 1 group (30 mice) and Example 2 group (30 mice).

[0062] Establishment of a mouse model of sepsis: A single intraperitoneal injection of LPS (20 mg / kg) and physiological saline solution (10 mL / kg) was administered, while mice in the control group received an equal volume of physiological saline intraperitoneally. Several hours after the intraperitoneal injection of LPS, the model mice gradually developed symptoms such as lethargy, bradykinesia, weakened resistance to capture, inability to fully open their eyes, and increased eye discharge.

[0063] 1.4 Administration

[0064] The experimental drug was the lyophilized powder obtained in Example 1 of this application. Before use, it was prepared into a saline suspension of the required concentration based on the average body weight of the mice. Administration was started by gavage two days before modeling, twice daily (morning and evening), for a total of six administrations over three days, with a dosage of 10 ml / kg. The control group and model group were administered the same volume of saline via gavage, at the same time as the traditional Chinese medicine group. Two hours after the sixth administration, the model group and traditional Chinese medicine group were intraperitoneally injected with LPS to construct the sepsis mouse model, while the control group was intraperitoneally injected with the same volume of saline.

[0065] After conversion based on the adult clinical equivalent dose, the dosage for each group is as follows:

[0066] Example 1 group: 1.43 g lyophilized powder / kg body weight; Example 2 group: 2.62 g lyophilized powder / kg body weight; The dosage of the control group (Banxia Xiexin Decoction) was determined to be 4.3 g lyophilized powder / kg body weight after literature search, equivalent dose conversion and clinical expert consensus demonstration.

[0067] The control group, namely Banxia Xiexin Decoction, was formulated with reference to published literature (such as Kong Li et al., Exploration of Banxia Xiexin Decoction in the Treatment of Gastrointestinal Dysfunction in Sepsis; Liu Weihong et al., Study on the Mechanism of Banxia Xiexin Decoction in Improving Intestinal Injury in Sepsis Mice by Regulating HO-1 Expression), and combined with the experience of TCM clinical experts in acute and critical care, the formula was as follows: Pinellia ternata 15g, dried ginger 9g, Scutellaria baicalensis 9g, Coptis chinensis 6g, ginseng 9g, prepared licorice root 9g, and jujube 9g; after being prepared into freeze-dried powder according to the same method as in Example 1, the experiment was conducted.

[0068] 1.5 Evaluation Indicators and Statistical Methods

[0069] With survival rate as the core, we observed changes in the physiological and mental state, weight, and body temperature of mice.

[0070] Survival rate data are count data, and Fisher's exact test was used to analyze differences in survival rates between groups. All statistical tests were two-tailed, and a p-value < 0.05 was considered statistically significant.

[0071] 2 Experimental Results

[0072] 2.1 Physiological and Mental State of Mice

[0073] During gavage administration, the mice in the traditional Chinese medicine group exhibited normal activity and good mental state, showing no significant difference from the untreated group. Approximately 4 hours after modeling, compared to the control group, the model group mice gradually showed symptoms such as ruffled fur, lethargy, slow movement, weakened arrest response, inability to fully open eyes, increased secretions, rapid breathing, and decreased body weight and temperature. Mice that were given the traditional Chinese medicine preparations described in Examples 1 and 2 beforehand showed significant relief from these symptoms.

[0074] 2.2 Changes in body weight and body temperature

[0075] During six consecutive oral administrations and model establishment, the mice in the example groups (especially example group 1) maintained good general condition and stable overall weight, consistent with the control group. After intraperitoneal injection of LPS, the model group mice gradually developed typical sepsis-like reactions, with deteriorating general condition accompanied by weight and body temperature decreases; shortly before death, they exhibited symptoms such as cold extremities. In contrast, the mice in example groups 1 and 2 also showed a decreasing trend in weight and body temperature after LPS stimulation, but the decrease was more moderate than in the model group, and their overall general condition was better than that of the model group, indicating the effectiveness of the traditional Chinese medicine preparations in examples 1 and 2.

[0076] 2.3 Survival rate

[0077] As shown in Table 1, 24 hours after modeling, the survival rate of the model group was only 23.3% (7 / 30), which was significantly lower than the 100% (5 / 5) of the blank group (P<0.01), indicating that the sepsis model was successfully constructed.

[0078] At different stages following drug administration, the various examples exhibited differentiated pharmacodynamic characteristics. In the early stage of 9 hours after drug administration, the survival rate of the Example 2 group remained at 93.3% (28 / 30), significantly higher than the 56.7% of the model group (P<0.01); the survival rate of the Example 1 group at this time point was 73.3%.

[0079] As the observation period extended to the later stages (24-96 hours), the Example 1 group gradually demonstrated superior sustained survival protection. At the 96-hour endpoint, the survival rate of the model group was only 6.7% (2 / 30). In contrast, the survival rate of the Example 1 group increased to 26.7% (8 / 30), which was four times that of the model group. This indicates that the composition described in Example 1 has clear practical application value in reducing the risk of death, and its superiority is significantly better than that of the control group (13.3%).

[0080] Table 1 Survival status of mice in different experimental groups

[0081]

[0082] The values ​​in Table 1 represent survival rates; the denominator in parentheses is the number of animals in each group, and the numerator is the number of surviving animals.

[0083] Example 6

[0084] Pharmacological experiment

[0085] 1. Materials and Instruments

[0086] 1.1 Laboratory Animals

[0087] Same as Example 5.

[0088] 1.2 Experimental Drugs

[0089] Same as Example 5.

[0090] 1.3 Instruments, Consumables and Reagents

[0091] Instruments: 4℃ / -20℃ refrigerator, analytical balance of 0.01 g / L, electronic balance, Eppendorf pipette, vortex apparatus, ultrasonic instrument, infrared thermometer, desiccator, Mindray BS-460 fully automated biochemical analyzer, Mindray BC-5000Vet fully automated hematology analyzer, VS200 digital pathology slide scanner, etc.

[0092] Reagents: Lipopolysaccharide (LPS, Sigma-Aldrich, L2630), physiological saline, 75% ethanol, 4% paraformaldehyde fixative; ELISA kits: Mouse IL-1β ELISA Kit (MU30369), Mouse IL-6 ELISA Kit (MU30044), Mouse TNF-α ELISA Kit (MU30030), D-Lactate (D-LA) ELISA Kit (MU30743) (purchased from Beinlai); Biochemical assay kits: ALT, AST, LDH assay kits.

[0093] 1.4 Animal grouping and establishment of a sepsis mouse model

[0094] Mice were randomly divided into 5 groups (n=15 / group): blank control group (blank group), model control group (model group), Banxia Xiexin Decoction control group (control group), low-dose group of Example 1, and low-dose group of Example 2. The method for establishing the sepsis mouse model was the same as in Example 5.

[0095] 1.5 Administration

[0096] Same as Example 5.

[0097] 1.6 Serum and tissue collection

[0098] Six hours after modeling, blood was collected from the eyes of mice under anesthesia. Anticoagulated whole blood was randomly selected from four mice in each group for routine blood tests. The blood from the remaining 11 mice was centrifuged to separate serum; six serum samples were randomly selected for detecting inflammatory factors (IL-1β, IL-6, TNF-α), and four to five samples were selected for detecting blood biochemical indicators (ALT, AST, LDH, and D-lactate). Lung tissue was collected, rinsed with physiological saline, and fixed in 4% paraformaldehyde for pathological examination.

[0099] 1.7 Detection Indicators and Methods

[0100] 1.7.1 Complete blood count: White blood cell, neutrophil and monocyte counts were measured using a Mindray BC-5000Vet blood cell analyzer.

[0101] 1.7.2 Serum inflammatory factor detection: Strictly follow the instructions for the ELISA kits for IL-1β, IL-6, and TNF-α. After incubation of samples with standards, washing, addition of enzymes, and color development, measure the OD value and calculate the concentration using a microplate reader at a wavelength of 450 nm.

[0102] 1.7.3 Serum D-Lactate Detection: Follow the instructions for the D-lactate ELISA kit. After the reaction, read the absorbance at 450 nm using a microplate reader / spectrophotometer, and calculate the D-lactate concentration based on the standard curve.

[0103] 1.7.4 Liver function biochemical index detection: Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and lactate dehydrogenase (LDH) levels were detected using a Mindray BS-460 blood biochemistry analyzer.

[0104] 1.7.5 Histopathological observation: After fixation, dehydration, embedding, sectioning (5μm), and H&E staining, lung tissue was scanned and images were acquired using a VS200 digital pathological slide scanner. The focus was on observing the integrity of alveolar structure, septal thickness, and inflammatory cell infiltration.

[0105] 1.8 Statistical Analysis

[0106] Data processing was performed using GraphPadPrism 10.6 software. Experimental data are expressed as mean ± standard deviation (Mean ± SD), and one-way ANOVA was used for comparisons among multiple groups. A p-value < 0.05 was considered statistically significant.

[0107] 2 Experimental Results

[0108] 2.1 Effects on complete blood count

[0109] like Figure 1As shown, the model group mice exhibited a significant systemic inflammatory response, with their white blood cell count (...). Figure 1 A) Mononuclear cells ( Figure 1 B) Neutrophils ( Figure 1 C) The count was significantly higher than that of the control group.

[0110] After intervention with the traditional Chinese medicine composition of the present invention (Examples 1 and 2), the counts of various inflammatory cells in the peripheral blood of mice showed a significant decreasing trend (P<0.05 to P<0.0001). Among them, the significant decrease in the number of neutrophils indicates that the composition of the present invention has an effective immunomodulatory ability and can inhibit excessive inflammatory cell mobilization.

[0111] 2.2 Effects on serum inflammatory factors

[0112] like Figure 2 As shown, the model group mice exhibited a significant systemic inflammatory response, with the main pro-inflammatory factor IL-1β (IL-1β) Figure 2 A) and IL-6 ( Figure 2 B) Levels were significantly higher than in the control group; TNF-α ( Figure 2 C) also shows an upward trend. Regarding the IL-6 index ( Figure 2 B): The positive control group reduced the abnormally elevated IL-6 levels in the model group (P<0.01); while both Example 1 and Example 2 groups showed more significant inhibitory effects (P<0.001), demonstrating superior inflammation downregulation effects compared to the positive control drug. Regarding TNF-α markers ( Figure 2 C): Compared with the model group, the positive drug control group failed to cause significant improvement; however, both Examples 1 and 2 significantly reduced TNF-α levels (P<0.05), indicating that the embodiments of the present invention possess significant technical advantages in inhibiting this key inflammatory factor that the positive drug does not have. The traditional Chinese medicine composition of the present invention (Example 1 group and Example 2 group) exhibited significant anti-inflammatory activity. Compared with the model group, after intervention with the composition of the present invention, the concentrations of serum inflammatory factors in mice showed a significant decreasing trend (P<0.05 to P<0.001), among which the TNF-α level in Example 1 group and Example 2 group was significantly lower than that in the model group (P<0.05). In particular, Example 1 showed more significant statistical significance in reducing the key pyrogen IL-1β (P<0.05). Figure 2 A). This demonstrates that the composition of the present invention can effectively inhibit the inflammatory cascade response and has good prospects for clinical application.

[0113] 2.3 Effects on D-lactic acid

[0114] like Figure 3As shown, compared with the blank group, the serum D-lactic acid level in the model group mice was significantly increased (P<0.05), indicating that the intestinal mucosal barrier was damaged and permeability increased after modeling. Compared with the model group, after intervention with the traditional Chinese medicine composition of the present invention, the D-lactic acid level in the Example 1 group was significantly reduced (P<0.05), indicating that it can effectively improve intestinal barrier function and reduce mucosal damage.

[0115] 2.4 Effects on liver function and tissue damage indicators

[0116] like Figure 4 The results showed that, compared with the control group, the serum levels of ALT, AST and LDH in the model group mice were significantly increased (P<0.01), indicating that the model mice had obvious hepatocellular damage and dysfunction.

[0117] The traditional Chinese medicine composition of this invention exhibits excellent liver-protective effects and is significantly superior to the positive control drug Banxia Xiexin Decoction in key indicators. Regarding the ALT index ( Figure 4 A): There was no significant difference between the positive drug control group and the model group, but after the intervention in Example 1, ALT levels were significantly reduced (P<0.05). Regarding AST levels ( Figure 4 B): The positive control group also showed no statistically significant difference, while both Example 1 and Example 2 significantly reduced AST levels (P<0.05). Regarding LDH levels ( Figure 4 C): Example 1 showed a significant inhibitory effect on abnormally elevated LDH levels (P<0.01), with an improvement effect comparable to the positive drug control group, demonstrating its substantial therapeutic potential; Example 2 also showed a significant reduction effect (P<0.05). All examples of this invention, along with the positive control group, showed significant reduction effects (P<0.05). These results confirm that the composition of this invention has superior pharmacodynamic characteristics compared to the traditional formula Banxia Xiexin Decoction in improving liver function damage associated with sepsis.

[0118] 2.5 Observation of lung tissue pathology and morphology

[0119] A systematic evaluation of HE-stained sections of lung tissue ( Figure 5 The results showed that the lung tissue in the model group exhibited typical pathological features of acute lung injury, including significant edema and thickening of the alveolar septa, abundant inflammatory exudate and leakage of red blood cells within the alveolar spaces, diffuse neutrophil infiltration, and collapse and fusion of alveolar structures in some areas. The pathological changes in the positive control group (Banxia Xiexin Decoction group) were less severe than those in the model group, with reduced alveolar septal edema and focal distribution of inflammatory infiltration, demonstrating a certain degree of lung protection.

[0120] The lung tissue pathological morphology of the embodiment groups (Examples 1 and 2) of this invention showed the most significant improvement, and was generally superior to the positive control group. Specifically, the alveolar structure was basically clear and intact, the septal edema was mild, there was almost no obvious exudate or hemorrhage in the alveolar cavity, and the inflammatory cell infiltration was minimal and scattered. The results indicate that the technical solution of this invention can more effectively maintain the integrity of the alveolar-capillary barrier and alleviate lung damage caused by sepsis.

[0121] Example 7

[0122] 1. General Information

[0123] The subjects were from the emergency ward and ICU ward of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, and their diagnoses met the 3.0 diagnostic criteria for sepsis (i.e. confirmed or suspected infection, and SOFA score ≥2).

[0124] 2. Intervention measures

[0125] The control group received conventional Western medicine treatment;

[0126] The formula for experimental group 1 was: 10 parts dried ginger, 60 parts ginseng, 6 parts rhubarb, 10 parts coptis, 50 parts prepared rehmannia root, 10 parts magnolia bark, 10 parts apricot kernel, 20 parts kudzu root, and 30 parts alisma.

[0127] The ratio of experimental group 2 was: 10 parts dried ginger, 50 parts ginseng, 6 parts rhubarb, 10 parts coptis, 15 parts pinellia, 10 parts scutellaria, 50 parts prepared rehmannia, and 10 parts magnolia bark.

[0128] The prescription dosage form is a granule formula purchased from Guangzhou Yifang Pharmaceutical Co., Ltd. The formula composition is prepared according to the ratios described in "Experimental Group 1" and "Experimental Group 2" above. It is taken orally with water, 50-100ml each time, once daily, divided into morning and evening oral administration or nasogastric tube (nasojejunal tube) injection. For patients with a gastrointestinal decompression tube, clamp the tube approximately 30 minutes after administration. If nausea, vomiting, abdominal distension, or significant worsening of symptoms occur immediately after administration, the gastrointestinal decompression tube should be opened immediately upon assessment. Continuous administration for 7 days or until the patient is discharged, leaves the ICU, or dies, whichever occurs first.

[0129] 3. Observation Indicators

[0130] SOFA scores and TCM syndrome scores were observed and recorded before treatment (upon ICU admission) and 7 days after treatment. Additionally, the 28-day period without organ support, total hospital stay, and number of target organ injuries during treatment were compared.

[0131] 4. Results

[0132] Compared with the control group treated with Western medicine alone, both Example 1 and Example 2 groups of the present invention showed significant therapeutic advantages: (1) Improved scores: After 7 days of treatment, the SOFA scores and TCM syndrome scores of patients in both Chinese medicine experimental groups (Example 1 and Example 2 groups) decreased more significantly than those in the control group, suggesting that the Chinese medicine composition can more effectively improve the organ function and clinical symptoms of patients. (2) Prognostic indicators: Compared with the control group, the 28-day time without organ support was significantly prolonged, the total hospitalization time was shortened, and the number of new target organ damages during the treatment period was significantly reduced.

[0133] This study shows that the traditional Chinese medicine compositions of Example 1 and Example 2 have potential therapeutic effects in the treatment of sepsis.

[0134] Example 8

[0135] Typical Case

[0136] Typical Case 1:

[0137] Patient 1, a 68-year-old male, was admitted to the hospital due to "chest tightness, shortness of breath, and difficulty expectorating phlegm for more than 10 days." He had a family history of motor neuron disease. After admission, his condition deteriorated rapidly, with high fever, confusion, and a progressive decline in oxygenation index. He was transferred to the ICU for treatment.

[0138] Current symptoms: Chest tightness and shortness of breath, difficulty expectorating phlegm, persistent high fever, altered mental status, constipation, and dark yellow urine. Dark tongue with a yellow, greasy coating, and thready pulse. Western medicine diagnosis: Sepsis, severe pneumonia, moderate acute respiratory distress syndrome (ARDS). Traditional Chinese medicine diagnosis: Qi stagnation (simultaneous involvement of the three jiaos, with mutual accumulation of toxins, heat, phlegm, and blood stasis).

[0139] Pathogenesis Analysis: This syndrome is due to the invasion of pathogenic toxins, causing disordered Qi circulation in the Triple Burner. The body's vital energy is already deficient while pathogenic heat is excessive, making it a severe case of mixed deficiency and excess, affecting all three burners simultaneously. In the Upper Burner, heat toxins obstruct the lungs, impairing their function of dispersing and descending Qi, resulting in chest tightness, shortness of breath, and difficulty expectorating phlegm; the heat also disturbs the mind, leading to mental confusion. In the Middle Burner, Qi stagnation in the bowels and the accumulation of turbid toxins disrupt the transmission mechanism, causing constipation; the Qi circulation is disordered, and the pivotal mechanism is impaired. In the Lower Burner, damp heat descends, hindering Qi transformation, resulting in dark yellow urine. The systemic combination of heat, toxins, phlegm, and blood stasis depletes Qi and Yin, disrupting the normal ascending and descending Qi circulation, gradually weakening the body's vital energy, hence the dark tongue, yellow and greasy tongue coating, and thready pulse. Treatment Principle: Strengthen the body's vital energy and consolidate the body's defenses, regulate the Triple Burner, clear heat and unblock the bowels, and detoxify and eliminate phlegm. Prescription (Formula from Example 1): Dried ginger 10g, ginseng slices 60g, rhubarb 6g, Coptis chinensis (processed with wine) 10g, Pinellia ternata (processed with wine) 15g, Scutellaria baicalensis (processed with wine) 10g, Rehmannia glutinosa (processed with wine) 50g, Magnolia officinalis (processed with ginger) 10g, bitter apricot kernel (processed with scalding) 10g, Pueraria lobata (processed with wine) 20g, Alisma plantago-aquatica (processed with salt) 20g. Usage: One dose per day, decocted in water and concentrated, administered via nasal feeding for 7 consecutive days.

[0140] Prognosis and Outcome: On the day of admission to the ICU, the patient was critically ill with severely impaired respiratory function. The oxygenation index was only 160.5 mmHg, meeting the criteria for moderate ARDS, and the Sequential Organ Failure Assessment (SOFA) score was 4. The aforementioned traditional Chinese medicine formula was immediately administered via nasogastric tube. After administration, the patient's chest tightness and shortness of breath significantly improved, allowing for smooth coughing up of phlegm. The patient's consciousness gradually cleared, bowel movements became regular, and urination became clearer. By the third day of treatment, a follow-up oxygenation index significantly improved to 316 mmHg. On the sixth day, the SOFA score dropped to 1 and remained at that level until the end of treatment. After seven days of treatment, the patient's overall condition stabilized, and they were successfully transferred out of the ICU for continued rehabilitation in a general ward.

[0141] Typical Case 2:

[0142] Patient 2, male, 77 years old, was admitted to the hospital due to "cough and sputum accompanied by fever for 3 weeks, worsening for 1 day". He has a history of Parkinson's disease, Alzheimer's disease, and sequelae of cerebral infarction. This time, he was transferred to the ICU for treatment due to acute respiratory failure and heart failure induced by severe pneumonia, accompanied by severe altered mental status.

[0143] Current symptoms: altered mental status, intermittent low-grade fever, emaciation, increased muscle tone, copious sputum that is difficult to expectorate, white and sticky sputum, constipation (absence for several days), cyanosis of the lips, pale tongue with a greasy coating, and a thready and rapid pulse. Western medicine diagnosis: sepsis, severe pneumonia, respiratory failure, heart failure. Traditional Chinese medicine diagnosis: Qi stagnation (stagnation of the Triple Burner, deficiency of vital energy and obstruction of turbidity).

[0144] Pathogenesis Analysis: The patient is elderly and has been ill for a long time, resulting in depletion of the essence and qi of the internal organs and a deficiency of vital energy. This external pathogenic factor triggered severe pneumonia, which is actually a case of "external pathogens triggering internal deficiency," leading to a sudden reversal of the body's qi mechanism and stagnation of the triple burner. Phlegm and turbidity obstruct the lungs, impairing their function of dispersing and descending qi, hence the rapid breathing and difficulty in expectorating phlegm; the sensory orifices are not nourished, hence the confusion. Spleen and stomach qi are deficient, their digestive function is weak, and dampness and turbidity accumulate internally. In addition, the lung qi fails to descend, leading to obstruction of the bowel qi, hence the constipation and thick, greasy tongue coating. Kidney qi is weak, and its function of qi transformation is impaired, hence the small amount of urine; turbid pathogens obstruct the lower burner, intertwining with pathogens in the middle and upper burners. The patient is thin, has a pale tongue and a thin pulse, indicating a deficiency of qi, blood, yin and yang; increased muscle tone and white, sticky phlegm indicate that phlegm and turbidity obstruct the meridians and qi mechanism on the basis of the underlying deficiency. The key pathogenesis of this disease lies in the extreme deficiency of vital energy, which weakens the body's ability to transform and transport nutrients, leading to the stagnation of pathological products such as dampness, phlegm, and turbidity in the Triple Burner, forming a critical condition of "deficiency leading to excess, and deficiency and excess becoming intertwined." Treatment principle: Strongly replenish vital energy, clear the bowels and eliminate turbidity, and promote the smooth flow of Qi in the Triple Burner. Prescription (Example 1 formula): Dried ginger 10g, ginseng slices 60g, rhubarb 6g, Coptis chinensis (processed with wine) 10g, Pinellia ternata (processed with wine) 15g, Scutellaria baicalensis (processed with wine) 10g, Rehmannia glutinosa (processed with ginger) 50g, Magnolia officinalis (processed with ginger) 10g, Prunus armeniaca (processed with bitter almond) 10g, Pueraria lobata (processed with salt) 20g, Alisma plantago-aquatica (processed with salt) 20g. Usage: One dose per day, decocted in water, administered via nasal feeding, for 7 consecutive days.

[0145] Prognosis and Outcome: After treatment with traditional Chinese medicine, the SOFA score decreased from 8 to 6. Systemic inflammatory response was significantly reduced, with CRP dropping dramatically from 79.2 mg / L to 12.4 mg / L, PCT decreasing from 0.28 ng / ml to 0.12 ng / ml, and white blood cell count and neutrophil percentage also decreasing synchronously, clearly indicating that infection-related inflammation was effectively controlled. In addition, NT-proBNP, reflecting cardiac workload, rapidly decreased from an initial 909 pg / ml to 192 pg / ml on day 3. With active intervention, this elderly patient with multiple underlying diseases and critical condition showed effective control and improvement in the risk of infection, cardiac function, and overall organ failure, resulting in a positive clinical outcome.

[0146] Typical Case 3:

[0147] Patient 3, male, 81 years old, was admitted to the hospital due to "intermittent fever for more than one month". He had a history of type 2 diabetes and Parkinson's disease. The day after admission, his condition deteriorated rapidly, and he suddenly fell into a coma. His blood oxygen saturation dropped to 70% and his heart rate was 130 beats / min. He was then intubated and transferred to the ICU.

[0148] Current symptoms: The patient is unconscious, breathing rapidly, has not had a bowel movement for several days, urinates scantyly and in yellow color, has abdominal distension with no significant resistance upon palpation, and both lungs have dry and wet rales. The tongue is dark red with a thick, greasy yellow coating; the pulse is weak and rapid, and feeble upon deep palpation. Western medicine diagnosis: Sepsis, severe pneumonia, type I respiratory failure. Traditional Chinese medicine diagnosis: Qi stagnation (obstruction of the Triple Burner, leading to collapse of the body's vital energy).

[0149] Pathogenesis Analysis: This case involves an elderly patient with a long history of illness, whose vital energy was inherently deficient. External pathogens invaded directly, causing a sudden disruption of the Qi mechanism in the Triple Burner. The lungs, acting as a protective canopy, were the first to be affected. Phlegm and heat obstructed the lungs, disrupting their function of dispersing and descending Qi, hence the rapid breathing and dry and wet rales in both lungs; heat also blocked the sensory orifices, disturbing the mind, resulting in coma. The spleen and stomach are the pivot of Qi's ascending and descending. The pathogenic heat penetrated inward, obstructing the middle burner, causing the clear Qi to fail to ascend and the turbid Qi to fail to descend, disrupting the pivot's function and exacerbating the overall Qi disorder. The obstruction of the bowel Qi prevented the elimination of turbid toxins from below, which then combined with the pathogenic heat from the upper and middle burners, forming a vicious cycle. The patient's advanced age and long-term illness, coupled with pre-existing Qi and Yin deficiency, further depleted the vital energy due to the rampant pathogenic toxins, resulting in a weak and rapid pulse—a critical condition of underlying deficiency and superficial excess, with the vital energy weakened and the pathogenic toxins trapped, leading to Qi stagnation and impending collapse. The dark tongue with a thick coating indicated the intermingling of phlegm, heat, and blood stasis. Treatment: In acute cases, treat the symptoms, consolidate the body's defenses, open the obstruction, and regulate the flow of Qi in the Triple Burner. Prescription (Formula from Example 2): Dried ginger 10g, ginseng 50g, rhubarb 6g, coptis 10g, pinellia 15g, scutellaria 10g, prepared rehmannia 50g, magnolia bark 10g. Usage: One dose per day, decocted in water and administered via nasal feeding for 7 consecutive days.

[0150] Prognosis and Outcome: During the ICU, after receiving the aforementioned traditional Chinese medicine nasogastric feeding and comprehensive treatment, the patient gradually regained consciousness, breathing became stable, abdominal distension significantly decreased, and bowel movements resumed. The SOFA score decreased from 5 to 1. The patient's gastrointestinal function score was 5 upon admission, improving to 1 by the third day of treatment and maintaining this level until the end of treatment, indicating that the Qi mechanism in the middle Jiao (middle burner) had returned to normal and the pivotal function had recovered. During treatment, the patient's inflammatory markers showed a decreasing trend. After treatment, the patient's overall condition stabilized, consciousness was clear, respiratory function significantly improved, the endotracheal tube was successfully removed, and the patient was transferred from the ICU to a general ward for continued rehabilitation.

[0151] Typical Case 4:

[0152] Patient 4, a 78-year-old male, was admitted to the emergency department due to "apathy, aphasia, and right-sided limb weakness for 3 hours." The patient had a history of diabetes. After admission, his level of consciousness further deteriorated, and he developed drowsiness, chest tightness, shortness of breath, and coarse breath sounds, with a progressive decrease in oxygen saturation. He was subsequently transferred to the ICU for treatment.

[0153] Current symptoms: Drowsy state, responsive to verbal stimuli, but unresponsive; weakness and limited movement in the right limbs. Rapid breathing, labored cough with rattling sounds in the throat; coarse breath sounds in both lungs, with scattered moist rales. Mild fever, pale complexion, and cold extremities. Abdominal distension, soft to the touch; no bowel movement for three days; scanty, yellow urine. Pale, dark tongue with teeth marks on the edges and a thick, greasy white coating; deep, thready, and rapid pulse, weak upon deep palpation of the cun pulse. Western medicine diagnosis: Sepsis, severe pneumonia, stroke (possibly acute ischemic stroke). Traditional Chinese medicine diagnosis: Qi stagnation (obstruction of the triple burner, phlegm and blood stasis obstructing the orifices, and impending collapse of vital energy).

[0154] Pathogenesis Analysis: The patient is elderly and has suffered from a long-term illness, resulting in internal depletion of qi and yin, and malnourishment of the internal organs. This sudden attack of "external wind triggering internal deficiency" caused phlegm and blood stasis to disturb the clear orifices, leading to stroke. Simultaneously, heat toxins blocked the lungs, inducing severe pneumonia, creating a critical state of sudden reversal and obstruction of qi in the upper, middle, and lower jiao. Phlegm and blood stasis in the upper jiao obstruct the orifices, causing apathy and aphasia; qi stagnation and dampness obstruction in the middle jiao cause abdominal distension and a greasy tongue coating; kidney qi deficiency in the lower jiao causes a weak pulse at the cun position. The patient's vital energy is on the verge of collapse, while pathogenic factors obstruct the flow, presenting a critical condition of mixed deficiency and excess. Treatment Principle: Strengthen the body, open the obstruction, replenish qi, eliminate phlegm, and clear the bowels. Prescription (Formula from Example 2): Dried ginger 10g, ginseng 50g, rhubarb 6g, coptis 10g, pinellia 15g, scutellaria 10g, prepared rehmannia 50g, magnolia bark 10g. Usage: One dose per day, decocted in water and administered via nasal feeding, for 7 consecutive days.

[0155] Prognosis and Outcome: After treatment with traditional Chinese medicine, the patient's condition improved significantly, with the SOFA score decreasing from 6 to 4. CRP decreased from 146.4 mg / L at admission to 19.8 mg / L. PCT decreased from 0.85 ng / ml to 0.2 ng / ml on day 3, and returned to the normal range (<0.1 ng / ml) on day 8, indicating that the related inflammation was effectively controlled. During the same period, the white blood cell count decreased from 11.58 × 10⁻⁶. 9 / L gradually decreased to 5.69×10 9 / L, entering the normal reference range; the percentage of neutrophils decreased from 94.4% to 75.7%, while the percentage of lymphocytes gradually recovered from 3% to 15.2%, reflecting the reduction of infection stress and the tendency of immune function to recover.

[0156] It should be noted that although this application uses Examples 1 and 2 as examples to verify the exact efficacy of this traditional Chinese medicine composition, those skilled in the art should understand that the core clinical efficacy of a traditional Chinese medicine formula originates from the synergistic effect of the ingredients (principal, assistant, adjuvant, and guide). Based on the fixed composition of the ingredients in this formula, reasonable fluctuations in the relative content and dosage of each component within the conventional clinical dosage range will not alter its core pharmacological activity and intervention pathway. Therefore, based on the compatibility logic disclosed in this application, other dosage combinations with similar proportions will also have predictable and similar efficacy.

[0157] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating sepsis, characterized in that, It is composed of the following ingredients in parts by weight: 10 parts dried ginger, 60 parts ginseng, 6 parts rhubarb, 10 parts coptis, 15 parts pinellia, 10 parts scutellaria, 50 parts prepared rehmannia, 10 parts magnolia bark, 10 parts apricot kernel, 20 parts kudzu root, and 30 parts alisma.

2. Traditional Chinese medicine granules, tablets, decoctions, oral liquids, or oral freeze-dried powders prepared from the traditional Chinese medicine composition of claim 1.

3. The method for preparing the oral lyophilized powder according to claim 2, characterized in that, Includes the following steps: (1) Weigh the medicinal materials / processed slices according to the weight parts, and first decoct rhubarb: soak rhubarb in water, add water and decoct, filter the decoction with gauze and combine the filtrates; (2) Decoction of the remaining medicinal materials: Soak the remaining medicinal materials in 6-10 times their weight of water, bring to a boil over high heat, and decoct over low heat at least twice; filter the decoction with gauze each time and combine the filtrates; (3) Concentration of medicinal liquid: Mix the filtrates obtained in steps (1) and (2) and concentrate them under vacuum at 50-60℃ until each milliliter of concentrated liquid is equivalent to 0.7-1.0g of medicinal slices, thus obtaining the concentrated Chinese medicine liquid; (4) Freeze-drying: The prepared concentrated Chinese medicine liquid is placed into a vacuum freeze-drying device for freeze-drying to obtain freeze-dried powder; In step (3), the simmering process is as follows: simmering for 5 minutes the first time, simmering for 30 minutes the second time, and simmering for 30 minutes the third time. In step (4), the specific steps of freeze drying are as follows: a) Pre-freezing: Pre-freezing at -80℃ for 12-24 hours; b) Sublimation drying: Vacuuming at -80℃ for 48-72 hours; c) Desorption drying: Drying at 30℃ for 24-48 hours, and freeze drying is completed.

4. The use of the traditional Chinese medicine composition of claim 1 in the preparation of a medicament for treating sepsis.

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