Use of a kurchi composition in the manufacture of a medicament for alleviating alcoholic liver damage

Abstract

The present application relates to the technical field of biological medicine, and more particularly to application of a keleisha composition in preparation of a medicament for relieving alcoholic liver injury, wherein the keleisha composition is used for prevention and treatment of alcoholic liver injury, and it is found that the keleisha composition can improve the antioxidant capacity by regulating the oxidative stress level of the body, repair the structural damage of hepatocytes, and restore the physiological functions of liver synthesis, metabolism and excretion, and has a significant effect, thereby providing a new scheme for relieving and treating alcoholic liver injury in clinic.

Description

Technical Field

[0001] This invention relates to the field of biomedical technology, and in particular to the application of the Keli Sha composition in the preparation of drugs for relieving alcoholic liver injury. Background Technology

[0002] Alcoholic liver injury is a complex process driven by multiple pathological mechanisms. Modern medicine summarizes this disease spectrum as a progressive evolution from steatosis and hepatitis to fibrosis and cirrhosis. Its core pathogenic links include: oxidative stress imbalance caused by alcohol metabolism, leading to lipid peroxidation of hepatocyte membranes and mitochondrial dysfunction; subsequent lipid metabolism disorders, manifested as abnormal accumulation of triglycerides in the liver and hyperlipidemia; and finally, progression to hepatocyte necrosis and excretory failure, resulting in elevated transaminases and jaundice.

[0003] In Traditional Chinese Medicine (TCM) theory, this continuous pathological process can be summarized as an evolutionary chain of "dampness, heat, phlegm, blood stasis, and turbidity," which gradually deepen and intertwine. Initially, alcohol-induced damp-heat damages the spleen and stomach, disrupting their digestive function. Damp-heat obstructs the middle jiao (middle burner), causing qi stagnation and impairing liver function, which closely corresponds to lipid metabolism abnormalities and fat accumulation in the liver observed in modern medicine. As the disease progresses, qi stagnation leads to blood stasis, and dampness condenses into phlegm. The mutual binding of phlegm and blood stasis obstructs the liver meridians, forming the TCM pathogenesis basis for continuous liver cell damage and even fibrosis. In more severe cases, the phlegm and turbidity generated by damp-heat obstruct the sensory orifices, leading to delirium and coma, precisely matching the pathological state of hepatic encephalopathy in modern medicine. Therefore, the core TCM pathogenesis of alcoholic liver injury lies in the vicious cycle of "qi stagnation, phlegm and blood stasis, and turbid toxins obstructing the sensory orifices."

[0004] Based on the above understanding, an ideal therapeutic drug should simultaneously target the modern pathological network of "oxidative stress-lipid metabolism disorder-excretion disorder" and break down the traditional Chinese medicine pathogenesis chain of "phlegm, blood stasis, turbidity, and obstruction." However, existing chemical drugs, such as silymarin and polyene phosphatidylcholine, have relatively singular targets and cannot fully cover such a complex pathological network. Traditional Chinese medicine formulas, such as Gehua Jiecheng Decoction and Yinchenhao Decoction, mainly focus on clearing heat and dampness, soothing the liver and strengthening the spleen. They are effective for early-stage mild cases of alcohol-induced damp-heat, but when facing severe cases of qi stagnation, phlegm and blood stasis, especially those accompanied by obstruction of the sensory orifices, their aromatic transformation and qi-opening effects are often insufficient, failing to effectively relieve the deep-seated pathological state. Therefore, developing a Chinese medicine composition that can effectively block oxidative stress, regulate lipid metabolism, and protect hepatocytes from the perspective of modern medicine, and also powerfully break through the predicament of "phlegm and stagnation" from the perspective of traditional Chinese medicine theory, thereby exerting the advantages of multi-target and multi-pathway holistic treatment, is a key technical problem that urgently needs to be solved in this field.

[0005] Keli Sha Composition is a modern Chinese medicine preparation developed based on traditional Chinese medicine theory. It is a capsule-formulated traditional Chinese medicine based on ancient folk remedies and prepared using modern pharmaceutical technology. It consists of twelve medicinal herbs: Atractylodes lancea, Angelica dahurica, Gleditsia sinensis, Acorus tatarinowii, Syzygium aromaticum, Piper longum, Asarum heterotropoides, Centipeda minima, Saltpeter, Realgar, Alum, and Borneol. This composition possesses the effects of clearing heat and detoxifying, promoting diuresis and resolving turbidity, strengthening the spleen and stomach, resolving phlegm and refreshing the mind, and warming and unblocking the Qi mechanism. Currently, it is widely used in clinical practice to treat diarrhea, dysentery, and heatstroke, effectively improving clinical symptoms such as fever, headache, nausea, vomiting, abdominal pain, diarrhea, and tenesmus. Analysis of the formula's composition and efficacy characteristics shows that the aromatic and warming properties, as well as its significant effects in resolving phlegm and opening the orifices, are highly consistent with the core pathogenesis of "Qi stagnation, phlegm and blood stasis, and turbid toxins obstructing the orifices" in the middle and late stages of alcoholic liver injury, thus providing a theoretical basis for intervention in this disease according to traditional Chinese medicine. However, to date, there are no literature reports on the use of Kelisha capsules in relieving or treating alcoholic liver injury.

[0006] Based on this, this application studies the interventional efficacy of the Keli Sha composition in relieving alcoholic liver injury. Summary of the Invention

[0007] This invention provides the application of the Kelisha composition in the preparation of drugs for relieving alcoholic liver injury, aiming to expand the new uses of Kelisha capsules in the field of relieving, preventing and treating alcoholic liver injury, and solves the problems existing in the prior art.

[0008] The technical solution adopted in this invention is: The use of the Keli Sha composition in the preparation of a drug for relieving alcoholic liver injury is provided. The Keli Sha composition comprises: 10%-20% Angelica dahurica, 5%-15% Atractylodes lancea, 5%-15% Acorus tatarinowii, 5%-10% Asarum heterotropoides, 2%-10% Piper longum, 2%-10% Centipeda minima, 5%-15% Gleditsia sinensis, 1%-5% Realgar, 2%-10% Clove, 5%-10% Saltpeter, 15%-25% Alum, and 0.5%-2% Borneol.

[0009] Furthermore, the composition of the Keli Sha composition is as follows: Angelica dahurica 18.43%, Atractylodes lancea 9.22%, Acorus tatarinowii 9.22%, Asarum heterotropoides 7.36%, Piper longum 5.54%, Centipeda minima 5.54%, Gleditsia sinensis 9.22%, Realgar 3.07%, Clove 5.54%, Saltpeter 7.36%, Alum 18.43%, Borneol 1.07%.

[0010] Furthermore, the Keli Sha composition is used as an ingredient to alleviate alcoholic liver injury by reducing serum alanine aminotransferase and aspartate aminotransferase levels, reducing serum triglycerides and total cholesterol, reducing low-density lipoprotein cholesterol and total bilirubin, upregulating serum high-density lipoprotein cholesterol levels, improving liver fat metabolism, reducing malondialdehyde production in hepatocytes, and / or increasing the activity of superoxide dismutase in hepatocytes.

[0011] Furthermore, the alcoholic liver injury refers to either acute alcoholic liver injury or chronic alcoholic liver injury.

[0012] Furthermore, the alcoholic liver injury includes alcoholic fatty liver, alcoholic hepatitis, alcoholic liver fibrosis, and alcoholic cirrhosis.

[0013] Furthermore, the drug comprises a diaphoretic composition and pharmaceutically acceptable excipients, wherein the excipients are excipients used to prepare the diaphoretic composition into different pharmaceutical formulations.

[0014] Furthermore, the excipients include one or more of fillers, disintegrants, binders, lubricants, solubilizers, propellants, flavoring agents, preservatives, and surfactants; the pharmaceutical preparation is a powder, mixture, granules, capsules, tablets, aerosols, emulsions, pills, tinctures, decoctions, injections, or oral liquids.

[0015] Furthermore, the preparation method of the Keli Sha composition is as follows: Among the above twelve medicinal materials, alum is mixed with saltpeter, borneol, and cloves and pulverized into fine powder, which is then sieved. The remaining seven medicinal materials, namely Angelica dahurica, Atractylodes lancea, Acorus tatarinowii, Asarum heterotropoides, Piper longum, Centipeda minima, and Gleditsia sinensis, are pulverized into fine powder. These are then mixed with the above four fine powders and realgar powder in a mixer. The speed is set to 30 Hz and the mixing time is 50 minutes. After mixing, the mixture is filled into capsules.

[0016] Furthermore, each capsule contains 0.28 g of contents.

[0017] The term "relief" above refers to the reduction, elimination, or prevention or slowing of symptoms on a temporary or permanent basis. The term "pharmaceutically acceptable" above means that it is generally safe, non-toxic, and not biologically or otherwise undesirable, and includes its acceptableness for both human and veterinary use.

[0018] The beneficial effects of this invention are: 1. Based on pharmacological efficacy, toxicity, and safety, this invention provides a novel application of the Keli Sha composition for alleviating alcoholic liver injury. The application results suggest that the Keli Sha composition has significant alleviating and repairing effects on alcoholic liver injury. It can enhance antioxidant capacity by regulating the body's oxidative stress level, repairing hepatocyte structural damage, and restoring the liver's physiological functions of synthesis, metabolism, and excretion. It is a potential candidate drug for the prevention and treatment of alcoholic liver injury, providing new ideas and directions for the treatment of related clinical diseases.

[0019] 2. Specifically, the Keli Sha composition of this invention can significantly improve the pathological changes of alcohol-induced hepatocellular damage, reverse the trend of weight loss in model animals and reduce liver index, downregulate serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels, and exert a hepatocellular protective effect; at the same time, it can reduce serum triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and total bilirubin (T-Bil) levels, upregulate high-density lipoprotein cholesterol (HDL-C) levels, and improve the liver's synthetic, metabolic and excretory functions. Further mechanistic studies show that the Keli Sha composition of this invention can significantly reduce the production level of malondialdehyde (MDA), a lipid peroxidation product, increase the activity of the antioxidant enzyme superoxide dismutase (SOD), effectively improve the body's oxidative stress state induced by alcohol stimulation, enhance the body's antioxidant capacity, and has a good effect in alleviating alcoholic liver damage. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the animal experimental procedure for alleviating alcoholic liver injury with the Keli Sha composition of the present invention; Figure 2 The percentage of relative body weight of mice in different treatment groups according to the present invention; Figure 3 The liver indices of mice in different treatment groups according to this invention; Figure 4 Gross anatomical diagrams of mouse livers in different treatment groups according to the present invention; Figure 5 Pathological examination of livers in mice under different treatment groups according to the present invention: HE staining and Oil Red O staining; Figure 6 The levels of triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) in the serum of mice in different treatment groups according to the present invention; Figure 7 The levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in the serum of mice in different treatment groups according to the present invention; Figure 8 The total bilirubin (T-Bil) content in the serum of mice in different treatment groups according to the present invention; Figure 9The values ​​represent the levels of malondialdehyde (MDA) and superoxide dismutase (SOD) in the liver tissue of mice in different treatment groups according to the present invention. Detailed Implementation

[0021] To clearly illustrate the technical features of this solution, the invention will be described in detail below through specific embodiments and in conjunction with the accompanying drawings.

[0022] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of this application.

[0023] The raw material composition of the dysentery-relieving composition involved in this embodiment is as follows: Angelica dahurica 10%-20%, Atractylodes lancea 5%-15%, Acorus tatarinowii 5%-15%, Asarum heterotropoides 5%-10%, Piper longum 2%-10%, Centipeda minima 2%-10%, Gleditsia sinensis 5%-15%, Realgar 1%-5%, Clove 2%-10%, Saltpeter 5%-10%, Alum 15%-25%, Borneol 0.5%-2%.

[0024] The preparation method of the above-mentioned Keli Sha composition includes the following steps: According to the above twelve medicinal materials and dosages, alum, saltpeter, borneol, and cloves are mixed and pulverized into fine powder, and sieved. The remaining seven medicinal materials, namely Angelica dahurica, Atractylodes lancea, Acorus tatarinowii, Asarum heterotropoides, Piper longum, Centipeda minima, and Gleditsia sinensis, are pulverized into fine powder. These are then placed in a mixer with the above four fine powders and realgar powder, set at a speed of 30 Hz, and mixed for 50 minutes. After mixing, the product is obtained. It can be further made into different drug preparations such as capsules.

[0025] The raw material composition of the Keli Sha composition used in the specific experiment in this embodiment is shown in Table 1 below: Table 1. Raw material composition of the Keli Sha composition

[0026] The experimental materials, animals, and methods used in the following examples are as follows: 1. Experimental materials and animals 1.1 Main Instruments and Reagents Table 2 Instrument and Equipment Information Table

[0027] Table 3 Reagent Information Sheet

[0028] 1.2 Laboratory Animals

[0029] Male C57BL / 6 mice were purchased from Shanghai Slack Laboratory Animal Co., Ltd., and housed in an SPF-grade barrier environment at the animal experimental center of Zhejiang Sukean Pharmaceutical Co., Ltd. The mice were kept in a temperature- and humidity-controlled animal room with a 12-hour circadian rhythm, and were acclimatized to standard rodent diet and water for one week. All animal experimental protocols in this study were approved by the ethics committee of Zhejiang Sukean Pharmaceutical Co., Ltd.

[0030] 2. Experimental Methods

[0031] 2.1 Animal modeling and drug administration

[0032] Thirty C57BL / 6 mice were randomly divided into five groups (n=6 per group) according to their body weight: a control group, a model group, and three dosage groups (KLSC-L, KLSC-M, and KLSC-H) of Kelisha capsules (batch number: 32507023, Zhejiang Sukean Pharmaceutical Co., Ltd.). From day 1 to day 4, group 1 received 8 mL / kg of physiological saline daily by gavage as a control. Groups 2 to 5 received 8 mL / kg of baijiu (a type of Chinese liquor) daily by gavage to establish the model. From day 5 to day 7, group 1 continued to receive 8 mL / kg of physiological saline daily by gavage, group 2 continued to receive 8 mL / kg of baijiu daily by gavage, and groups 3 to 5 received 8 mL / kg of baijiu daily by gavage, plus additional low, medium, and high doses of the Kelisha combination (148 mg / kg, 295 mg / kg, and 590 mg / kg, respectively). On day 8 after the drug administration was completed, all surviving mice were sacrificed, blood was collected, and the livers were dissected for further analysis. The specific experimental procedure is as follows: Figure 1 As shown.

[0033] Daily cage-side observation of the animals was conducted, and when necessary, the animals were removed for detailed observation. Observation included whether the animals were dead or near death, their activity level, appearance and fur, presence of external injuries, and fecal condition. Special attention was paid to observing and recording the mice's physical characteristics, such as coat color and luster, neurobehavioral performance, such as mental state, activity level, and changes in body weight, as well as other core physiological indicators.

[0034] The test results were analyzed using the statistical analysis software GraphPad Prism (version 10.1.2). Quantitative data were expressed as mean ± standard deviation (x ± s). One-way ANOVA was used for comparisons among multiple groups, and a p-value < 0.05 was considered statistically significant. P < 0.05, P < 0.01, P < 0.001, P < 0.0001.

[0035] The application of the present invention will be described in detail below through specific embodiments.

[0036] The following embodiments are for illustrative purposes only and are not intended to limit the scope of this application. Experimental methods in the following embodiments without specific conditions should preferably refer to the guidelines given in this application, or may be performed according to experimental manuals or conventional conditions in the art, or refer to experimental methods known in the art. Unless otherwise specified, all methods are conventional methods in the art. In the following specific embodiments, temperature and time parameters are involved, allowing for acceptable deviations due to instrument testing accuracy or operational precision. The equipment and materials used are all commercially available or commonly used in the art.

[0037] Example 1: Effects of the Keli Sha composition on body weight and liver weight in mice

[0038] Body weight and liver weight determination: Before and after the experiment, the body weight of surviving animals was measured, the wet weight of the liver was measured after dissection, and the liver index was calculated.

[0039] Relative body weight percentage (%) = body weight after the experiment Body weight before the experiment × 100; Liver index (HSI) = liver weight (g) × 100 / body weight (g).

[0040] Before the experiment began, there was no statistically significant difference in body weight among the five groups of mice (P > 0.05). Figure 2 and Figure 3 As shown, after the experiment, compared with the control group, the model group mice showed a significant decrease in body weight (P<0.0001) and a significant increase in liver index (P<0.0001). After treatment with different doses of the Keli Sha composition, compared with the model group, the mice showed a significant increase in body weight and a significant decrease in liver index. Among them, the low-dose group (KLSC-L) and medium-dose group (KLSC-M) of the Keli Sha composition showed similar effects in increasing body weight and decreasing liver index, while the high-dose group (KLSC-H) showed the best effect in improving both body weight and liver index. The results indicate that treatment with the Keli Sha composition can improve the body weight and liver index levels in mice with alcoholic liver injury, and has a certain protective effect on the mouse liver.

[0041] Example 2: Effects of the Keli Sha composition on liver tissue damage in mice

[0042] Histopathological examination of liver tissue: The largest lobe of the liver was harvested and fixed with tissue fixative at room temperature for 24 hours. The tissue was then dehydrated and embedded in paraffin. The embedded paraffin block was cut into sections approximately 4 μm thick and mounted on glass slides. The tissue sections were stained with hematoxylin-eosin and Oil Red O staining solutions, respectively, and then mounted with neutral resin. Finally, the sections were placed under an inverted microscope to observe the pathological changes in the liver tissue.

[0043] like Figure 4 As shown, compared with the blank group, the livers of mice in the model group showed obvious whitening and enlargement after alcohol induction. Figure 5 HE staining results showed that the liver tissue of mice in the blank control group had clear outlines, intact lobular structure, normal morphology of hepatocytes, regular arrangement, and radial orderly distribution around the central vein. In the model group, the integrity of liver tissue cell structure was disrupted, liver cords were disordered, and significant fat vacuoles and inflammatory cell infiltration were observed in the liver tissue. Oil Red O staining showed large areas of lipid droplet deposition, indicating that alcohol stimulation had caused liver function damage in mice, and the alcoholic liver injury model was successfully established.

[0044] After intervention with the Keli Sha composition, liver tissue damage was significantly improved in all low, medium, and high dose groups: HE staining results showed that the liver tissue structure gradually returned to a dense and orderly state, the number of fat vacuoles was significantly reduced, and hepatocyte damage was effectively repaired; Oil Red O staining showed a reduction in the area of ​​lipid droplet deposition, indicating that liver metabolic function gradually recovered, and the above-mentioned improvement effect became more significant with increasing dosage. In summary, the gross morphological observation and section staining results together indicate that the Keli Sha composition can improve alcohol-induced pathological damage to mouse liver tissue, and this improvement effect is dose-dependent.

[0045] Example 3: Effects of the Keli Sha Composition on Liver Function in Mice

[0046] Serum biochemical tests: Serum samples were collected from each group of mice, and blood biochemical indicators were measured using a blood biochemistry analyzer: total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (T-BiL).

[0047] Blood biochemistry results systematically confirmed the successful establishment of an alcoholic liver injury model and verified the intervention effect of the Keli Sha combination. Model validation results showed that the model group mice exhibited typical multidimensional liver injury characteristics. Figure 6As shown, the levels of triglycerides (TG), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C) were elevated, while the level of high-density lipoprotein cholesterol (HDL-C) was decreased, indicating that there was fat accumulation in the liver and that its ability to process cholesterol was severely impaired. After administration, the four lipid indicators significantly recovered, demonstrating that the Keli Sha composition can improve the liver's ability to metabolize fat. Figure 7 The results showed that the levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in the liver of the model group were elevated, confirming that the integrity of the hepatocyte membrane was damaged and a large number of intracellular enzymes were released into the blood. Figure 8 Elevated total bilirubin (T-Bil) levels further indicate that the liver has lost its normal ability to process and excrete metabolic products. However, after intervention with the Keli Sha composition, ALT and AST levels decreased, and T-Bil returned to normal. The high-dose group showed statistically significant differences in all indicators compared to the model group, demonstrating the best intervention effect. These results prove that the Keli Sha composition can repair hepatocyte structure and restore the liver's synthetic, metabolic, and excretory functions to normal, verifying the protective effect of the Keli Sha composition on liver function.

[0048] Example 4: Effects of the Keli Sha composition on oxidative stress levels in mice

[0049] Detection of oxidative stress levels in liver tissue: Liver samples were mixed with physiological saline at a mass ratio of 1:9 and homogenized to prepare a 10% (w / w) liver homogenate. Specific parameters: centrifugation temperature 4℃, rotation speed 3000 r / min, centrifugation time 15 min. After processing, the contents of superoxide dismutase (SOD) and malondialdehyde (MDA) were measured according to the kit instructions.

[0050] The specific mechanisms of action of the above-mentioned damage are as follows: Figure 9 As shown in the figure, compared with the blank control group, the malondialdehyde (MDA) content in the model group was significantly increased (P<0.05), and the superoxide dismutase (SOD) activity was significantly decreased (P<0.0001). As the end product of lipid peroxidation, the increased MDA content indicates oxidative damage to hepatocyte membrane lipids; SOD is a key antioxidant enzyme in the body, mainly mediating the scavenging of superoxide anion free radicals. These results suggest that excessive oxidative stress in the model mice leads to impaired antioxidant function, which is a key upstream initiating step in hepatocyte damage and liver failure. After intervention with the Keli Sha composition, the MDA level in mice decreased, and the SOD level increased. The differences between the medium-dose and high-dose groups and the model group were statistically significant, indicating that the Keli Sha composition can effectively improve the body's oxidative stress level, and damaged hepatocytes can be effectively repaired after antioxidant capacity is restored. These results further verify the alleviating effect of the Keli Sha composition on alcoholic liver injury.

[0051] The above studies demonstrate that the Keli Sha composition of this invention has significant alleviating and repairing effects on alcoholic liver injury. It can enhance antioxidant capacity by regulating the body's oxidative stress level, repairing hepatocyte structural damage, and restoring the liver's physiological functions of synthesis, metabolism, and excretion. Furthermore, within the dosage range implemented in this invention, the drug's effect on improving liver function exhibits a dose-dependent characteristic, with statistically significant differences observed in all test indicators in the high-dose group, indicating the best therapeutic effect. Therefore, the Keli Sha composition can serve as a potential candidate drug for the prevention and treatment of alcoholic liver injury, providing new ideas and directions for the treatment of related clinical diseases.

[0052] The present invention has been described in detail above. The specific embodiments described above should not be construed as limiting the scope of protection of the present invention. Any alternative modifications or variations made to the embodiments of the present invention by those skilled in the art will fall within the scope of protection of the present invention.

[0053] Any aspects of this invention not described in detail are well-known to those skilled in the art.

Claims

1. The application of the Keli Sha composition in the preparation of a drug for relieving alcoholic liver injury, wherein the Keli Sha composition comprises: 10%-20% Angelica dahurica, 5%-15% Atractylodes lancea, 5%-15% Acorus tatarinowii, 5%-10% Asarum heterotropoides, 2%-10% Piper longum, 2%-10% Centipeda minima, 5%-15% Gleditsia sinensis, 1%-5% Realgar, 2%-10% Clove, 5%-10% Saltpeter, 15%-25% Alum, and 0.5%-2% Borneol.

2. The application according to claim 1, characterized in that, The Keli Sha composition is used to alleviate alcoholic liver injury by reducing serum alanine aminotransferase and aspartate aminotransferase levels, lowering triglycerides and total cholesterol, lowering low-density lipoprotein cholesterol and total bilirubin, upregulating high-density lipoprotein cholesterol levels, improving liver fat metabolism, reducing malondialdehyde production in hepatocytes, and / or increasing the activity of superoxide dismutase in hepatocytes.

3. The application according to claim 1 or 2, characterized in that, The alcoholic liver injury referred to here is either acute or chronic alcoholic liver injury.

4. The application according to claim 1 or 2, characterized in that, The drug comprises a diaphoretic composition and pharmaceutically acceptable excipients, wherein the excipients are those used to prepare the diaphoretic composition into different pharmaceutical formulations.

5. The application according to claim 4, characterized in that, The excipients include one or more of fillers, disintegrants, binders, lubricants, solubilizers, propellants, flavoring agents, preservatives, and surfactants; the pharmaceutical preparation is a powder, mixture, granules, capsules, tablets, aerosols, emulsions, pills, tinctures, decoctions, injections, or oral liquids.

6. The application according to claim 1 or 2, characterized in that, The preparation method of the Keli Sha composition is as follows: Among the above twelve medicinal materials, alum, saltpeter, borneol, and clove are mixed and pulverized into fine powder, and sieved. The remaining seven medicinal materials, namely Angelica dahurica, Atractylodes lancea, Acorus tatarinowii, Asarum heterotropoides, Piper longum, Centipeda minima, and Gleditsia sinensis, are pulverized into fine powder. These are then mixed with the above four fine powders and realgar powder in a mixer. After mixing, the mixture is filled into capsules.

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