Traditional Chinese medicine preparation for treating sepsis lung injury and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine preparation for treating sepsis lung injury, which comprises fructus forsythiae, raw rhubarb, raw cape jasmine, scutellaria baicalensis, platycodon grandiflorum, exocarpium citri grandis, cacumen biotae, radix ophiopogonis, radix pseudostellariae, cistanche, honey-fried licorice root and the like, and the traditional Chinese medicine preparation can reduce acute lung injury caused by sepsis, serum tumor necrosis factors and interleukin levels of patients, regulate the level of T lymphocyte subpopulation, and improve the curative effect of the lung injury. The traditional Chinese medicine composition can effectively treat the septicopyemia lung injury, is beneficial to relieving the inflammatory response of a body, and has a synonymous meaning with anti-infection treatment.

Description

Technical Field

[0001] The present invention relates to the field of information technology, and in particular to a traditional Chinese medicine preparation for treating sepsis-induced lung injury and a preparation method thereof. Background Art

[0002] Sepsis-induced lung injury is a serious complication that threatens patients' lives, and its treatment faces multiple challenges. Traditional Chinese medicine has problems such as insufficient extraction of effective ingredients and unstable efficacy in the treatment of such diseases. How to reduce the toxic side effects while retaining the effective ingredients of Chinese medicine has become the key to research. Based on Chinese medicines such as Forsythia suspensa, raw rhubarb, and raw gardenia, how to optimize their compatibility ratio to achieve the best synergistic effect? ​​In the preparation process, the treatment of raw rhubarb is particularly critical. How to reduce its laxative effect while retaining its anti-inflammatory and antibacterial effects? During the decoction process, the dissolution rules of the effective ingredients of different Chinese medicinal materials are different. How to ensure that the effective ingredients of multiple medicinal materials are fully extracted? During the concentration and drying process, heat-sensitive components are easily destroyed. How to retain the effective ingredients to the greatest extent while ensuring the stability of the preparation? In addition, in view of the complex pathological mechanism of septic lung injury, how to effectively regulate the patient's immune function through Chinese medicine preparations, inhibit excessive inflammatory response, and avoid immunosuppression? The solution of these problems is crucial to improving the effect of Chinese medicine preparations in the treatment of septic lung injury, and is also a major challenge facing the modernization of Chinese medicine research. Summary of the invention

[0003] The present invention provides a traditional Chinese medicine preparation for treating sepsis-induced lung injury and a preparation method thereof, which mainly comprises:

[0004] 6-15 parts of Forsythia suspensa, 3-15 parts of raw rhubarb, 6-10 parts of raw gardenia, 3-10 parts of scutellaria baicalensis, 3-10 parts of platycodon, 3-10 parts of tangerine peel, 6-12 parts of Platycladus orientalis, 9-15 parts of ophiopogon japonicus, 9-30 parts of pseudoginseng, 6-10 parts of Cistanche deserticola, and 2-10 parts of roasted liquorice.

[0005] Furthermore, the raw materials are processed, including: using a traditional water decoction method to process raw rhubarb, controlling the water temperature within a preset range, and maintaining the boiling time for a preset time.

[0006] Furthermore, the decocting of the mixed raw materials includes: decocting the mixed raw materials twice, the first time adding water amount is a preset multiple of the quality of the medicinal materials, decocting for a preset time, the second time adding water amount is a preset multiple of the quality of the medicinal materials, decocting for a preset time, to obtain a primary filtrate and a secondary filtrate respectively.

[0007] Furthermore, the filtrate is concentrated under reduced pressure, including: combining two filtrates, concentrating by reduced pressure distillation, controlling the concentration temperature within a preset range, the vacuum degree within a preset range, and obtaining a concentrated solution with a crude drug concentration of a preset value.

[0008] Furthermore, the concentrated liquid is spray-dried, including: setting the air inlet temperature within a preset range, the air outlet temperature within a preset range, and the spray pressure within a preset range to obtain a Chinese medicine extract powder, wherein the dosage form of the Chinese medicine preparation is one of a mixture, granules, syrup, extract or pills.

[0009] Furthermore, the Chinese medicine preparation is used to reduce the levels of serum tumor necrosis factor, interleukin-6, and interleukin-10 in patients with septic lung injury, regulate the levels of T lymphocyte subsets, and inhibit inflammatory storm reactions.

[0010] The technical solution provided by the embodiment of the present invention may have the following beneficial effects:

[0011] The present invention discloses a Chinese medicine preparation for treating septic lung injury and a preparation method thereof. The preparation is prepared from 11 kinds of Chinese medicines such as Forsythia suspensa, raw rhubarb, and raw gardenia as raw materials through specific processing, decoction, concentration, and drying processes. Among them, the steaming treatment of raw rhubarb is a key step, which can not only weaken its purgative effect and toxicity, but also retain the effective ingredients. The preparation process adopts the techniques of double decoction, reduced pressure concentration, and spray drying to ensure the extraction and preservation of the effective ingredients. The Chinese medicine preparation finally prepared can be used to reduce the level of inflammatory factors in patients with septic lung injury, regulate immune function, and inhibit inflammatory storm reaction, thereby achieving the purpose of treating septic lung injury. The present invention improves the therapeutic effect by optimizing the Chinese medicine formula and preparation process, and provides a new option for the treatment of septic lung injury. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 The present invention is a flow chart of a Chinese medicine preparation for treating septic lung injury and a preparation method thereof.

[0013] Figure 2 The present invention is a schematic diagram of a traditional Chinese medicine preparation for treating septic lung injury and a preparation method thereof.

[0014] Figure 3 This is another schematic diagram of a traditional Chinese medicine preparation for treating septic lung injury and a preparation method thereof according to the present invention.

[0015] Figure 4 This is another schematic diagram of a traditional Chinese medicine preparation for treating septic lung injury and a preparation method thereof according to the present invention.

[0016] Figure 5 This is another schematic diagram of a traditional Chinese medicine preparation for treating septic lung injury and a preparation method thereof according to the present invention.

[0017] Figure 6This is another schematic diagram of a traditional Chinese medicine preparation for treating septic lung injury and a preparation method thereof according to the present invention.

[0018] Figure 7 Comparison of alveolar and interstitial congestion and exudation.

[0019] Figure 8 A comparative analysis graph is shown for the immunofluorescence results. DETAILED DESCRIPTION

[0020] In order to enable those skilled in the art to better understand the technical solutions in this specification, the technical solutions in the embodiments of this specification will be clearly and completely described below in conjunction with the drawings in the embodiments of this specification. Obviously, the described embodiments are only part of the embodiments of this specification, not all of the embodiments. Based on the embodiments in this specification, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of this specification.

[0021] like Figure 1 In this embodiment, a Chinese medicine preparation for treating septic lung injury and a preparation method thereof may specifically include:

[0022] S101, obtaining Forsythia suspensa, raw rhubarb, raw gardenia, scutellaria baicalensis, platycodon grandiflorum, red tangerine peel, Platycladus orientalis leaves, ophiopogon japonicus, Pseudostellaria pseudoginseng, Cistanche deserticola, and roasted liquorice as raw materials; mixing the raw materials, decocting them, and filtering to obtain an extract.

[0023] When obtaining Forsythia suspensa as a raw material, it is necessary to select mature and dry Forsythia suspensa fruits, because its heat-clearing and detoxifying effects mainly come from the active ingredients in the fruit. Forsythia suspensa is usually picked in autumn, when the content of active ingredients in the fruit is the highest. To ensure the efficacy, the Forsythia suspensa fruits need to be naturally dried or dried at low temperature to control their water content below 8% to avoid mold or loss of active ingredients due to excessive humidity. When obtaining raw rhubarb, it is necessary to select the rhizome part of rhubarb, because its purgative and heat-clearing and detoxifying effects are mainly concentrated in the roots. The collection time of raw rhubarb is preferably in spring or autumn, when the active ingredients accumulated in the roots are the most abundant. After collection, the soil and impurities need to be removed, and the slices need to be dried. The drying temperature is controlled below 40°C to prevent high temperature from destroying its active ingredients. When obtaining raw gardenia, it is necessary to select mature and dry gardenia fruits, because its effects of purging fire and relieving restlessness and clearing heat and dampness mainly come from ingredients such as gardenia glycoside in the fruit. Gardenia is usually picked in autumn, and the fruit color is best when it turns from green to yellow. After collection, it is necessary to dry in the sun or at low temperature to reduce its water content to less than 10% to keep the efficacy stable. When obtaining Scutellaria baicalensis, the root of Scutellaria baicalensis should be selected, because its effects of clearing heat and dampness and purging fire and detoxification are mainly concentrated in the root. The best time to collect Scutellaria baicalensis is in autumn, when the roots accumulate the most active ingredients. After collection, the soil and impurities need to be removed, and the slices need to be dried. The drying temperature is controlled below 50°C to prevent the loss of effective ingredients. When obtaining Platycodon grandiflorum, the root of Platycodon grandiflorum needs to be selected, because its effects of clearing lungs and removing phlegm and relieving throat and pus are mainly concentrated in the root. The best time to collect Platycodon grandiflorum is in autumn, when the roots accumulate the most active ingredients. After collection, the soil and impurities need to be removed, and the slices need to be dried. The drying temperature is controlled below 45°C to keep the efficacy stable. When obtaining Huajuhong, the mature peel of Huaju needs to be selected, because its effects of regulating qi, widening the middle and drying dampness and removing phlegm mainly come from volatile oils and naringin in the peel. The best time to collect Huajuhong is in autumn, when the content of active ingredients in the peel is the highest. After collection, the peel needs to be dried in the sun or at low temperature to reduce its water content to below 12% to maintain its efficacy. When obtaining Platycladus orientalis leaves, it is necessary to select the tender branches and leaves of Platycladus orientalis, because its effects of cooling blood and stopping bleeding and resolving phlegm and relieving cough are mainly concentrated in the flavonoids in the tender branches and leaves. The best time to collect Platycladus orientalis leaves is in spring, when the content of active ingredients in the tender branches and leaves is the highest. After collection, it needs to be dried in the sun or at low temperature to reduce its water content to below 10% to maintain its efficacy. When obtaining Ophiopogon japonicus, it is necessary to select the tubers of Ophiopogon japonicus, because its effects of nourishing yin and moistening the lungs and benefiting the stomach and promoting fluid production are mainly concentrated in the polysaccharides and saponins in the tubers. The best time to collect Ophiopogon japonicus is in autumn, when the content of active ingredients in the tubers is the highest. After collection, the soil and impurities need to be removed, and the slices need to be dried, and the drying temperature should be controlled below 60°C to maintain the efficacy. When obtaining Pseudostellariae Radix, you need to choose the root tubers, because its effects of invigorating Qi, strengthening the spleen, promoting body fluid and moistening the lungs are mainly concentrated in the saponins and polysaccharides in the root tubers. The best time to collect Pseudostellariae Radix is ​​in autumn, when the content of active ingredients in the root tubers is the highest.After collection, soil and impurities need to be removed, and the slices need to be dried. The drying temperature should be controlled below 50°C to maintain the efficacy. When obtaining Cistanche deserticola, the fleshy stems of Cistanche deserticola need to be selected, because its effects of tonifying kidney yang and benefiting essence and blood are mainly concentrated in the phenylethanol glycosides in the fleshy stems. The collection time of Cistanche deserticola is preferably in spring or autumn, when the content of effective ingredients in the fleshy stems is the highest. After collection, it needs to be dried in the sun or at low temperature to reduce its water content to below 8% to maintain the efficacy. When obtaining licorice, the root of licorice needs to be selected, because its effects of tonifying spleen and qi and detoxifying and relieving cough are mainly concentrated in the glycyrrhizic acid and liquiritin in the roots. The collection time of licorice is preferably in autumn, when the content of effective ingredients in the roots is the highest. After collection, soil and impurities need to be removed, and the slices need to be honey-roasted to reduce its water content to below 10% to enhance the efficacy. After mixing the above raw materials in proportion, the amount of water added and the decoction time need to be controlled during decoction. During the first decoction, the amount of water added is 4-6 times the mass of the mixture, and the decoction time is 50-60 minutes to ensure that the active ingredients are fully dissolved. During the decoction process, a low heat must be maintained to avoid high temperature from destroying the active ingredients. After the decoction is completed, a primary filtrate and medicinal residues are obtained by filtration. When the medicinal residues are decocted for the second time, the amount of water added is 2-3 times the mass of the mixture, and the decoction time is 20-30 minutes to further extract the remaining active ingredients. After the decoction is completed, a secondary filtrate is obtained by filtration. After the primary filtrate and the secondary filtrate are combined, they are concentrated to a crude drug concentration of 0.8-1.2g / mL to ensure that the concentration of the active ingredients of the preparation meets the treatment requirements. Temperature and pressure must be controlled during the concentration process to prevent decomposition or volatilization of the active ingredients.

[0024] S102. The weight proportions of the raw materials are: 6-15 parts of Forsythia suspensa, 3-15 parts of raw rhubarb, 6-10 parts of raw gardenia, 3-10 parts of scutellaria baicalensis, 3-10 parts of platycodon grandiflorum, 3-10 parts of Citrus aurantium, 6-12 parts of Platycladus orientalis leaves, 9-15 parts of Ophiopogon japonicus, 9-30 parts of Pseudostellaria pseudoginseng, 6-10 parts of Cistanche deserticola, and 2-10 parts of roasted liquorice.

[0025] 6-15 parts of Forsythia suspensa, which has the effects of clearing away heat and detoxifying, reducing swelling and dispersing nodules, and is often used to treat symptoms such as wind-heat colds, sore throats, etc. In the treatment of septic lung injury, Forsythia suspensa can effectively inhibit inflammatory reactions and reduce damage to lung tissue. In specific implementation, the dosage of Forsythia suspensa can be adjusted according to the severity of the patient's condition. Mild patients can use 6 parts, and severe patients can increase to 15 parts to achieve the best therapeutic effect. 3-15 parts of raw rhubarb, which has the effects of purging heat and relieving constipation, cooling blood and detoxifying, and is often used to treat symptoms such as constipation caused by excess heat. In the treatment of septic lung injury, raw rhubarb can remove toxins from the body and reduce the inflammatory response of the lungs through a purgative effect. In specific implementation, the dosage of raw rhubarb can be adjusted according to the patient's constipation condition. Severe constipation can use 15 parts, and mild constipation can use 3 parts to ensure the efficacy of the drug. 6-10 parts of raw gardenia, raw gardenia has the effects of clearing heat and dampness, cooling blood and detoxifying. In the treatment of septic lung injury, raw gardenia can clear the heat and dampness, clear the triple-burner heat, treat the qi-level heat syndrome and lung heat symptoms, and promote the disappearance of inflammation. In specific implementation, the dosage of raw gardenia can be adjusted according to the patient's lung heat degree. Those with more severe lung heat can use 10 parts, and those with less severe heat can use 6 parts to achieve the best therapeutic effect. 3-10 parts of scutellaria, scutellaria has the effects of clearing heat and dampness, purging fire and detoxifying, and is commonly used for symptoms such as lung heat congestion, lung failure to clear and descend, cough with thick sputum, and exogenous febrile diseases. In the treatment of septic lung injury, scutellaria can clear lung fire and upper-burner heat symptoms and inhibit inflammatory reactions through the effects of clearing heat and dampness. In specific implementation, the dosage of scutellaria can be adjusted according to the patient's phlegm heat degree. Those with more severe phlegm heat can use 10 parts, and those with less severe heat can use 3 parts to ensure the efficacy of the drug. 3-10 parts of Platycodon grandiflorum, Platycodon grandiflorum has the effects of promoting lung and relieving throat, removing phlegm and pus, and is an important medicine for the lung meridian. It is often used to treat symptoms such as lung heat cough, sore throat, etc. In the treatment of septic lung injury, Platycodon grandiflorum can promote the discharge of sputum and reduce the inflammatory response of the lungs by promoting lung and relieving throat. In specific implementation, the dosage of Platycodon grandiflorum can be adjusted according to the sputum situation of the patient. Those with more sputum can use 10 parts, and those with less sputum can use 3 parts to achieve the best therapeutic effect. 3-10 parts of Huajuhong, Huajuhong has the effects of regulating qi and widening the middle, drying dampness and removing phlegm, and is often used to treat symptoms such as chest and abdominal distension, phlegm and cough. In the treatment of septic lung injury, Huajuhong can promote the smooth flow of qi and reduce the symptoms of phlegm heat in the lungs by the effect of drying dampness and removing phlegm. In specific implementation, the dosage of Huajuhong can be adjusted according to the degree of phlegm heat of the patient. Those with heavier phlegm and dampness can use 10 parts, and those with lighter phlegm can use 3 parts to ensure the efficacy of the drug. 6-12 portions of Platycladus orientalis leaves, which have the effects of cooling blood and stopping bleeding, resolving phlegm and relieving cough, are often used to treat lung heat cough, phlegm and cough, etc. In the treatment of septic lung injury, Platycladus orientalis leaves can relieve lung heat cough, yellow and sticky phlegm symptoms, and inhibit inflammatory response by clearing and descending lung qi, resolving phlegm and relieving cough.In specific implementation, the dosage of Platycladus orientalis can be adjusted according to the color and amount of the patient's sputum. 12 parts can be used for those with a lot of sputum, and 6 parts can be used for mild cases to achieve the best therapeutic effect. 9-15 parts of Ophiopogon japonicus, Ophiopogon japonicus has the effects of nourishing yin and moistening the lungs, clearing the heart and removing troubles, and is often used to treat symptoms such as dry cough, restlessness and insomnia. In the treatment of septic lung injury, Ophiopogon japonicus can alleviate the dryness symptoms of the lungs and promote the disappearance of inflammation by nourishing yin and moistening the lungs. In specific implementation, the dosage of Ophiopogon japonicus can be adjusted according to the degree of yin deficiency of the patient. 15 parts can be used for those with more severe yin deficiency, and 9 parts can be used for those with less severe yin deficiency to ensure the efficacy of the drug. 9-30 parts of Pseudostellaria chinensis, Pseudostellaria chinensis has the effects of invigorating qi and strengthening the spleen, promoting body fluid and moistening the lungs, and is often used to treat symptoms such as spleen deficiency and fatigue, insufficient stomach yin, and dry cough due to lung dryness. In the treatment of septic lung injury, Pseudostellaria chinensis can enhance the body's immunity and promote the repair of lung tissue by invigorating qi and strengthening the spleen. During specific implementation, the dosage of Radix Pseudostellariae can be adjusted according to the degree of Qi deficiency of the patient. 30 parts can be used for patients with severe Qi deficiency, and 9 parts can be used for patients with milder Qi deficiency to achieve the best therapeutic effect. 6-10 parts of Cistanche deserticola, which has the effects of tonifying kidney yang, benefiting essence and blood, and moistening the intestines and relieving constipation, is commonly used for symptoms such as deficiency of essence and blood, dry intestines and constipation. In the treatment of septic lung injury, Cistanche deserticola enhances the body's disease resistance and promotes the repair of lung tissue by tonifying kidney yang and moistening the intestines. During specific implementation, the dosage of Cistanche deserticola can be adjusted according to the degree of kidney yang deficiency of the patient. 10 parts can be used for patients with severe kidney yang deficiency, and 6 parts can be used for patients with milder kidney yang deficiency to ensure the efficacy of the drug. 2-10 parts of Radix Glycyrrhizae Preparata, which has the effects of tonifying spleen and replenishing qi, clearing away heat and detoxifying, is commonly used to treat symptoms such as expectorant and cough, and relieve acute pain. In the treatment of septic lung injury, Radix Glycyrrhizae Preparata can enhance the body's immunity and reduce the inflammatory response of the lungs by tonifying spleen and replenishing qi. During specific implementation, the dosage of roasted licorice can be adjusted according to the degree of spleen and stomach weakness of the patient. For those with severe spleen and stomach weakness, 10 portions can be used, and for those with milder spleen and stomach weakness, 2 portions can be used to achieve the best therapeutic effect.

[0026] S103, processing the raw materials, wherein the raw rhubarb needs to be steamed to weaken its laxative effect and remove its toxicity; during the steaming process, process parameters such as temperature and time are strictly controlled to ensure that effective ingredients such as allium quinones are not destroyed.

[0027] Raw rhubarb needs to be steamed during the processing process. The main purpose of this step is to weaken its laxative effect and remove toxicity while retaining the effective ingredients. During the steaming process, temperature and time are the key process parameters. The steaming temperature is usually controlled between 100℃ and 120℃, and the time is generally 30 minutes to 1 hour. The specific parameters need to be adjusted according to the texture and water content of rhubarb. For example, for rhubarb with a harder texture, the steaming time can be appropriately extended to 40 minutes to ensure that its internal components are fully heated; while for rhubarb with a higher water content, the steaming time can be shortened to 25 minutes to avoid the loss of effective ingredients due to excessive heating. During the steaming process, onion quinone components are the key protection objects. This type of component is easy to decompose at high temperature, so the temperature needs to be strictly controlled to ensure its stability. For example, steaming at 100℃ for 30 minutes can make the retention rate of onion quinone components reach more than 90%, while when the temperature exceeds 120℃, the retention rate of onion quinone components may drop below 70%, affecting the efficacy. In addition, during the steaming process, attention should be paid to uniform heating of the medicinal materials to avoid local excessive temperature causing damage to the ingredients. For example, the layered steaming method can be used to evenly spread the rhubarb in the steamer, with the thickness of each layer controlled at about 3 cm to ensure uniform heat conduction. Through strict control of the above process parameters, the laxative effect of raw rhubarb can be effectively weakened and its toxicity can be removed, while retaining its effective ingredients, ensuring the efficacy and safety of the preparation.

[0028] S104, decocting the mixed raw materials, including: decocting the mixed raw materials twice, the first time adding water amount is a preset multiple of the quality of the medicinal materials, decocting for a preset time, the second time adding water amount is a preset multiple of the quality of the medicinal materials, decocting for a preset time, to obtain a primary filtrate and a secondary filtrate respectively.

[0029] The mixed raw materials are decocted, including decocting the mixed raw materials twice, the first water addition amount is a preset multiple of the quality of the medicinal material, the decocting preset time, the second water addition amount is a preset multiple of the quality of the medicinal material, the decocting preset time, and the primary filtrate and the secondary filtrate are obtained respectively. During the first decocting, the amount of water added is 5-6 times the quality of the medicinal material, and the decocting time is 50-60 minutes. The purpose is to fully extract the active ingredients in the medicinal material through sufficient water and time. Too much water may cause dilution of the active ingredients, and too little water cannot be fully extracted, so 5-6 times the amount of water is an optimized range. Too short decocting time will lead to insufficient extraction, and too long may destroy heat-sensitive components. The time setting of 50-60 minutes can not only ensure extraction efficiency, but also avoid component loss. During the second decocting, the amount of water added is 2-3 times the quality of the medicinal material, and the decocting time is 20-30 minutes. The purpose is to further extract the active ingredients remaining in the filter residue. The amount of water and time for the second decoction are relatively reduced, because most of the active ingredients have been extracted in the first decoction. Reducing the amount of water and time can improve efficiency and avoid wasting resources. After the first filtrate and the second filtrate are combined, they are concentrated to obtain a Chinese medicine preparation with a crude drug concentration of 1g / mL. This concentration can not only ensure the efficacy, but also facilitate subsequent use and storage. By decoctioning twice and combining the filtrates, the active ingredients in the medicinal materials can be extracted to the maximum extent, improving the efficacy and stability of the preparation.

[0030] S105, concentrating the filtrate under reduced pressure, including: combining two filtrates, concentrating by reduced pressure distillation, controlling the concentration temperature within a preset range, the vacuum degree within a preset range, and obtaining a concentrated solution with a crude drug concentration of a preset value.

[0031] The two filtrates are combined and concentrated by vacuum distillation. The concentration temperature and vacuum degree are controlled within a preset range to obtain a concentrated solution with a preset crude drug concentration. The two filtrates are combined to ensure that all active ingredients are fully extracted to avoid waste. The vacuum distillation method reduces the system pressure and makes the liquid boil at a lower temperature, thereby reducing the decomposition of heat-sensitive components. Controlling the concentration temperature within a preset range, usually 40-60°C, can prevent high temperature from damaging the drug ingredients. The vacuum degree is controlled at 0.08-0.09MPa, which helps to speed up the evaporation rate and improve the concentration efficiency. The preset value of the crude drug concentration of the final concentrated solution is 1.5-2.0g / ml, ensuring the stability and efficacy of the drug ingredients. This method not only improves production efficiency, but also retains the active ingredients of the drug and ensures the quality of the final product.

[0032] S106. Spray drying the concentrated liquid, including: setting the air inlet temperature within a preset range, the air outlet temperature within a preset range, and the spray pressure within a preset range to obtain a Chinese medicine extract powder, wherein the dosage form of the Chinese medicine preparation is one of a mixture, a granule, a syrup, an extract or a pill.

[0033] When the concentrate is spray-dried, the inlet air temperature must first be set within a preset range, usually between 150°C and 200°C, to ensure that the water in the concentrate can evaporate quickly while avoiding high temperature damage to the active ingredients of traditional Chinese medicine. Too high an inlet air temperature may cause degradation of the active ingredients, while too low an inlet air temperature may reduce the drying efficiency. For example, when preparing the Lianhuangyin extract powder, the inlet air temperature is set to 180°C, which can effectively balance the drying speed and ingredient protection. The outlet air temperature also needs to be within a preset range, usually between 80°C and 100°C. The outlet air temperature reflects the actual temperature of the material during the drying process. Too low an air temperature may cause the powder to have too high a moisture content, affecting stability; too high an air temperature may cause the powder to agglomerate or lose ingredients. For example, in the spray drying process of Lianhuangyin, the outlet air temperature is set to 90°C, which can ensure that the moisture content of the powder is controlled below 5% while maintaining the activity of the active ingredients. Spray pressure is one of the key parameters in the spray drying process, usually set between 0.2MPa and 0.4MPa. The spray pressure determines the size and uniformity of the droplets, which in turn affects the drying efficiency and the particle size distribution of the powder. For example, in the spray drying of Lianhuangyin, the spray pressure is set to 0.3MPa, which can generate fine droplets with uniform particle size, improve the drying efficiency, and ensure the solubility and stability of the final powder. Through the above parameter settings, the final Chinese medicine extract powder can be further processed into a variety of dosage forms. For example, after mixing the powder with an appropriate amount of excipients, it can be made into a mixture for patients to take directly; or the powder can be mixed with powdered sugar, starch, etc. to make granules, which are easy to carry and take; the powder can also be dissolved in syrup to make a syrup, which is suitable for children or patients with dysphagia; in addition, the powder can also be mixed with an appropriate amount of adhesive to make an extract or pill to meet the medication needs of different patients. For example, when preparing Lianhuangyin granules, the powder obtained by spray drying is mixed with microcrystalline cellulose and lactose in a certain proportion, granulated by a granulator, and then dried and sieved to finally obtain uniform granules. This dosage form is not only convenient for patients to take, but also improves the stability and bioavailability of the drug.

[0034] S107. The Chinese medicine preparation is used to reduce the serum tumor necrosis factor, interleukin-6, and interleukin-10 levels in patients with septic lung injury, regulate the levels of T lymphocyte subsets, and inhibit inflammatory storm reactions.

[0035] The Chinese medicine preparation can effectively inhibit the excessive activation of inflammatory response by reducing the serum tumor necrosis factor (TNF-α) level in patients with septic lung injury. Tumor necrosis factor is a key mediator in the inflammatory cascade, and its elevated level can lead to cytokine storm, further aggravating lung tissue damage. For example, the Chinese medicine preparations of Forsythia suspensa and Scutellaria baicalensis contain a variety of flavonoids, which can reduce the generation of TNF-α by inhibiting the activation of the nuclear factor-κB (NF-κB) signaling pathway, thereby alleviating the inflammatory response. Clinical data show that after using the Chinese medicine preparation, the patient's TNF-α level dropped from 100pg / mL before treatment to below 50pg / mL, significantly improving the patient's inflammatory state. The Chinese medicine preparation further inhibits the inflammatory response by regulating the level of interleukin-6 (IL-6). IL-6 is a proinflammatory cytokine, and its elevated level can lead to the continuation and amplification of the inflammatory response. The raw rhubarb and raw gardenia in the Chinese medicine preparation contain anthraquinones and iridoids, which can reduce the level of IL-6 by inhibiting its transcription and secretion. For example, in clinical trials, the patient's IL-6 level dropped from 80pg / mL before treatment to below 30pg / mL, significantly reducing the damage to lung tissue caused by inflammatory response. Chinese herbal preparations balance inflammatory responses by regulating interleukin-10 (IL-10) levels. IL-10 is an anti-inflammatory cytokine, and its increased level can inhibit excessive inflammatory response and protect tissues from damage. Ophiopogon japonicus and Radix Pseudostellariae in Chinese herbal preparations contain polysaccharides and triterpenoid saponins, which can promote the secretion of IL-10 and enhance the body's anti-inflammatory ability. Clinical data show that the patient's IL-10 level increased from 10pg / mL before treatment to more than 20pg / mL, significantly improving the body's anti-inflammatory ability. Chinese herbal preparations enhance the body's immune function by regulating the levels of T lymphocyte subsets (CD3+, CD4+, CD8+, CD4+ / CD8+). T lymphocytes play an important role in immune regulation, and imbalance in their subset levels can lead to immune dysfunction. Cistanche deserticola and licorice in traditional Chinese medicine preparations contain a variety of active ingredients that can restore the balance of T lymphocytes at the subpopulation level by regulating the differentiation and function of T lymphocytes. For example, in clinical trials, the CD4+ / CD8+ ratio of patients increased from 1.2 before treatment to more than 1.5, significantly improving the body's immune function. Traditional Chinese medicine preparations reduce sepsis lung injury by inhibiting the inflammatory storm reaction. The inflammatory storm is a key link in the pathological process of sepsis, and its overactivation can lead to multiple organ dysfunction. The various active ingredients in traditional Chinese medicine preparations can inhibit the initiation and amplification of the inflammatory storm through synergistic effects. For example, in clinical trials, the patient's inflammation score dropped from 10 points before treatment to less than 5 points, significantly improving the patient's clinical symptoms and prognosis.

[0036] S108. The Chinese medicine preparation for treating septic lung injury and pharmaceutically acceptable excipients.

[0037] The Chinese medicine preparation for treating septic lung injury is usually composed of a variety of Chinese medicinal materials, which have anti-inflammatory, antibacterial and antioxidant properties and can effectively alleviate the lung injury caused by sepsis. For example, Chinese medicinal materials such as Scutellaria baicalensis, Honeysuckle and Forsythia suspensa are often used in such preparations, which can inhibit the release of inflammatory factors and reduce lung tissue damage. Pharmaceutically acceptable excipients refer to substances used to improve drug stability, solubility, taste or appearance in the pharmaceutical process. In Chinese medicine preparations for treating septic lung injury, commonly used excipients include sucrose, dextrin and starch. These excipients can not only improve the solubility and stability of the drug, but also improve the patient's taste experience and increase medication compliance. In the preparation process, the Chinese medicinal materials are first extracted, and the effective ingredients are obtained by decoction or alcohol extraction. Then the extract is filtered to remove impurities to obtain a clear liquid medicine. Next, the liquid medicine is concentrated to a certain density, and the excipients are added for mixing. Finally, through processes such as drying or granulation, the drug is made into dosage forms such as mixtures, granules, syrups, extracts or pills. Specifically, the relative density during the concentration process is 1.10, which is determined by experiments and can ensure the stability and effectiveness of the drug in subsequent processes. The proportion of added sucrose and dextrin also needs to be strictly controlled, usually between 5% and 10%, to ensure that the taste and solubility of the drug are optimal. When preparing granules, the uniformity of mixing the drug solution and excipients is crucial. Uneven mixing will lead to uneven distribution of drug ingredients and affect the efficacy. Therefore, appropriate stirring speed and stirring time need to be adopted during the mixing process. Usually, the stirring speed is controlled at 50 to 100 revolutions per minute, and the stirring time is between 10 and 20 minutes. After preparation, the drug needs to be tested for quality, including the determination of indicators such as drug content, solubility, and stability. These test items can ensure the safety and effectiveness of the drug during storage and use. For example, the content of active ingredients in the drug is determined by high-performance liquid chromatography to ensure the quality consistency of each batch of drugs. In practical applications, Chinese medicine preparations for the treatment of septic lung injury usually need to be used in combination with other treatment methods, such as antibiotic treatment, respiratory support, etc. The mechanism of action of Chinese medicine preparations combined with Western medicine treatment can play a synergistic role, improve the treatment effect, and reduce the occurrence of complications. In clinical use, after taking Chinese medicine preparations, patients usually need to observe the improvement of their symptoms, such as relief of dyspnea and decrease in inflammatory indicators. According to the individual differences of patients and the severity of the disease, doctors can adjust the dosage and course of the drug to achieve the best therapeutic effect. The long-term safety of Chinese medicine preparations is also an important factor to consider. Through long-term toxicity tests and clinical observations, ensure that the drug will not have adverse effects on the patient's liver and kidney function during long-term use. For example, by regularly monitoring the patient's liver and kidney function indicators, possible adverse reactions can be discovered and dealt with in a timely manner.Finally, the storage conditions of Chinese medicine preparations also need to be strictly controlled. They are usually required to be stored in a cool and dry place, away from direct sunlight and high temperature environments. These measures can extend the shelf life of the drug and ensure that the drug is still highly active when used.

[0038] The following clinical data are provided as a role for traditional Chinese medicine preparations in treating septic lung injury:

[0039] Clinical trials:

[0040] A total of 56 patients with septic lung injury due to phlegm-heat obstructing the lung syndrome admitted to the intensive care unit and respiratory intensive care unit of the emergency center of the Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine from February 2023 to January 2024 were selected. The Western medicine diagnostic criteria refer to the "Chinese Guidelines for Emergency Treatment of Sepsis / Septic Shock (2018)" and "Diagnostic Criteria for Acute Lung Injury / Acute Respiratory Distress Syndrome (Draft)", and the TCM syndrome diagnostic criteria refer to the "Standards for Diagnosis and Efficacy of TCM Internal Medicine Diseases and Syndromes" of the State Administration of Traditional Chinese Medicine.

[0041] Control group: According to the Sepsis 3.0 guidelines, the following were given: 1. Intensive care, routine aseptic operation; 2. Invasive or non-invasive assisted ventilation (Savina ventilator produced by Drager, Germany; biphasic positive airway pressure ventilation, respiratory rate: 12-20 times / min, tidal volume: 6-8ml / kg, adjusted inspired oxygen concentration (Fi02) and positive end-expiratory pressure (positive end-expiratory pressure) pressure, PEEP), ensure that Sp02 reaches more than 90%; 3. Fluid resuscitation: It is recommended to use crystalloid as the first-line choice for resuscitation; 4. Use norepinephrine as the first-line vasoactive drug (norepinephrine 10-18mg is prepared in 50ml of normal saline, pumped by a micropump, pumping speed: 3-5ml / h); 5. Control infection: It is best to use antibiotics within 1 hour after diagnosis, give meropenem 1g, prepared in 100ml of normal saline, and give intravenous drip, drip rate: 80-100 drops / min, 3 times / day; 5. Closely observe the patient's condition and give symptomatic treatment in time. During the treatment process, warm boiled water is given every day 150ml, nasogastric feeding twice a day in the morning and evening as a control. The patient's name, age, gender, consciousness, respiratory rate, body temperature, mean arterial blood pressure, heart rate, and date of admission to the EICU and RICU were recorded in detail. At the same time, the patient's inflammation-related indicators (PCT, IL-6, IL-10, TNF-α), oxidative stress indicators (MDA, SOD), T lymphocyte subsets (CD4+, CD8+), APACHEⅡ scores, and TCM syndrome scores were recorded on the first and fifth days after enrollment. The improvement of the efficacy of TCM syndrome was calculated as follows: efficacy index = [(sum of scores before treatment - sum of scores after treatment) / sum of scores before treatment] × 100%.

[0042] 1.1 Changes in infection indicators of the two groups of patients before and after treatment:

[0043] As shown in Table 1, after intra-group comparison, PCT, IL-6, IL-10, and TNF-α of the two groups of patients on the 5th day after treatment were lower than those before treatment, and the differences were statistically significant (P < 0.01); after inter-group comparison, there was no significant difference between the two groups before treatment (P > 0.05), and they were comparable; on the 5th day after treatment, the Lianhuangyin group was better than the control group, and the difference was statistically significant (P < 0.05).

[0044] Table 1 Changes of infection indicators in the two groups before and after treatment

[0045]

[0046] 1.2 Changes of oxidative stress indicators in the two groups before and after treatment:

[0047] As shown in Table 2, there was no significant difference between the two groups before treatment (P>0.05), and they were comparable; on the 5th day after treatment, the MDA of the Lianhuangyin group was lower than that of the control group, and the SOD was higher than that of the control group, and the difference was statistically significant (P<0.05).

[0048] Table 2 Changes of oxidative stress indicators in the two groups before and after treatment

[0049]

[0050] 1.3 Changes of T lymphocyte subsets in the two groups of patients before and after treatment

[0051] As shown in Table 3, after intra-group comparison, CD4+ and CD8+ of the two groups of patients decreased on the 5th day after treatment compared with those before treatment, and the differences were statistically significant (P < 0.01); after inter-group comparison, there was no significant difference between the two groups before treatment (P > 0.05), and they were comparable; on the 5th day after treatment, the CD4+ of the Lianhuangyin group was higher than that of the control group, and the CD8+ was lower than that of the control group, and the difference was statistically significant (P < 0.05).

[0052] Table 3 Changes of T lymphocyte subsets in the two groups of patients before and after treatment

[0053]

[0054] 1.4 Changes in APACHE-II and TCM syndrome scores of the two groups of patients before and after treatment

[0055] As shown in Table 4, after intra-group comparison, the APACHE-II and TCM syndrome scores of the two groups of patients decreased on the 5th day after treatment compared with those before treatment, and the differences were statistically significant (P < 0.01); after inter-group comparison, there was no significant difference between the two groups before treatment (P > 0.05), and they were comparable; on the 5th day after treatment, the Lianhuangyin group was better than the control group, and the difference was statistically significant (P < 0.05).

[0056] Table 4 Comparison of APACHE-II scores between the two groups before and after treatment

[0057]

[0058] 1.5 Comparison of TCM efficacy between the two groups of patients

[0059] As shown in Table 5, the effective rate of TCM efficacy of the Lianhuangyin group was 78.57%, and that of the control group was 57.14%. The efficacy of the experimental group was better than that of the control group, and the difference was statistically significant (P<0.05).

[0060] Table 5 Comparison of the efficacy of TCM syndromes after treatment

[0061]

[0062] Note: After χ2 test, Z=4.139, P=0.042<0.05, the difference is statistically significant.

[0063] 1.6 Changes in safety indicators of the two groups of patients before and after treatment

[0064] As shown in Table 6, there was no significant difference in AST, ALT and SCr between the two groups of patients after 5 days of treatment (P>0.05) after intra-group comparison; there was no significant difference between the two groups before treatment (P>0.05), which was comparable.

[0065] Table 6 Changes in safety indicators of the two groups of patients before and after treatment

[0066]

[0067] Animal experiment example:

[0068] 1. Animal Modeling

[0069] 1.1 Main experimental reagents

[0070]

[0071] 1.3 Experimental Grouping

[0072] ①Control group

[0073] ②Model group (LPS group)

[0074] ③Lianhuangyin group

[0075] ④TLRs inhibitor group

[0076] 1.4 Experimental procedures

[0077] 1) Adaptive feeding for one week.

[0078] 2) Animal model preparation: Animal welfare and experimental procedures were carried out in accordance with the National Institutes of Health Laboratory Animal Care and Use Guide, and LPS (10 mg / kg, intraperitoneal injection) was injected. After LPS modeling was successful, 30 μl miR-NC adenovirus was injected into the tail vein of the LPS+miR-NC group, and 30 μl miR-489 overexpression adenovirus was injected into the tail vein of the LPS+miR-489 group, once a day for 2 days. The Lianhuangyin group was gavaged with Lianhuangyin (1080 mg / kg) once in the morning and evening, and the administration lasted for 1 week. The TLRs inhibitor group was gavaged with MD2-TLR4-IN-1 (10 mg / kg) dissolved in 0.1% CMC-Na once a day for 1 week.

[0079] 2. Preparation of paraffin sections and HE staining

[0080] 2.1 Experimental Materials

[0081] Table 1 Experimental instruments

[0082]

[0083] Table 2 Experimental reagents

[0084]

[0085] 2.3 Experimental Results

[0086] As attached Figure 7 As shown, the alveoli and interstitium were congested and exudated, and the inflammatory factors increased. The condition improved after injection of TLRs inhibitors and Lianhuangyin.

[0087] 3. Immunofluorescence double labeling detection

[0088] 3.1 Experimental Materials

[0089] Table 1 Experimental instruments

[0090]

[0091] Table 2 Experimental reagents

[0092]

[0093] 3.3 Experimental Results

[0094] like Figure 8 As shown, the immunofluorescence results showed (400 times): compared with the control group, the expression of Vwf in the model group increased significantly, and the expression of SP-D decreased significantly. This was reversed after drug administration. ( * Compared with the control group, * P<0.05, ** P<0.01, *** P < 0.001, **** P < 0.0001; # Compared with the model group, # P<0.05, ## P<0.01, ### P < 0.001, #### P<0.0001)

[0095] In summary, the Chinese medicine preparation finally prepared can be used to reduce the level of inflammatory factors in patients with septic lung injury, regulate immune function, and inhibit inflammatory storm reaction, thereby achieving the purpose of treating septic lung injury. The present invention improves the therapeutic effect by optimizing the Chinese medicine formula and preparation process, and provides a new option for the treatment of septic lung injury.

[0096] The description of the above embodiments is only used to help understand the technical solutions and core ideas of the present application. Ordinary technical personnel in this field should understand that they can still modify the technical solutions recorded in the aforementioned embodiments, or replace some of the technical features therein with equivalents. However, these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present application.

Claims

1. A Chinese medicine preparation for treating septic lung injury and a preparation method thereof, characterized in that: include: Forsythia suspensa, raw rhubarb, raw gardenia, scutellaria baicalensis, platycodon grandiflorum, tangerine peel, arborvitae leaves, ophiopogon japonicus, pseudostellaria, cistanche deserticola, and roasted liquorice are obtained as raw materials; the preparation method comprises processing, extraction, reduced pressure concentration, and spray drying to obtain a traditional Chinese medicine preparation for treating septic lung injury.

2. The Chinese medicine preparation according to claim 1, characterized in that: The weight parts of the raw materials are: 6-15 parts of Forsythia suspensa, 3-15 parts of raw rhubarb, 6-10 parts of raw gardenia, 3-10 parts of scutellaria baicalensis, 3-10 parts of platycodon, 3-10 parts of tangerine peel, 6-12 parts of Platycladus orientalis, 9-15 parts of ophiopogon japonicus, 9-30 parts of pseudoginseng, 6-10 parts of Cistanche deserticola, and 2-10 parts of roasted liquorice.

3. The Chinese medicine preparation and preparation method thereof according to claim 1, characterized in that: The raw materials are processed, including: The raw rhubarb is processed using the traditional water decoction method, the water temperature is controlled within a preset range, and the boiling time is maintained at a preset time.

4. The Chinese medicine preparation and preparation method thereof according to claim 3, characterized in that: The method of decocting the mixed raw materials comprises: The mixed raw material is decocted twice, the first time the amount of water added is a preset multiple of the quality of the medicinal material, the decocting time is preset, and the second time the amount of water added is a preset multiple of the quality of the medicinal material, the decocting time is preset, to obtain a primary filtrate and a secondary filtrate respectively.

5. The Chinese medicine preparation and preparation method thereof according to claim 1, characterized in that: The filtrate is concentrated under reduced pressure, comprising: The two filtrates are combined and concentrated by vacuum distillation. The concentration temperature and vacuum degree are controlled within a preset range to obtain a concentrated solution with a preset crude drug concentration.

6. The Chinese medicine preparation according to claim 1, characterized in that: The concentrated solution is spray-dried, comprising: The air inlet temperature is set within a preset range, the air outlet temperature is set within a preset range, and the spray pressure is set within a preset range to obtain a Chinese medicine extract powder. The dosage form of the Chinese medicine preparation is one of a mixture, granules, syrup, extract or pills.

7. The Chinese medicine preparation according to claim 1, characterized in that: The traditional Chinese medicine preparation is used to reduce the serum tumor necrosis factor, interleukin-6 and interleukin-10 levels of patients with septic lung injury, regulate the levels of T lymphocyte subsets and inhibit inflammatory storm reactions.

8. The Chinese medicine preparation as claimed in claim 1, comprising pharmaceutically acceptable excipients.

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