Application of traditional Chinese medicine composition in preparation of medicine for pneumonia

Abstract

The invention relates to application of a traditional Chinese medicine composition in preparation of a medicine for treating pneumonia, which is characterized in that the traditional Chinese medicine composition is prepared from gypsum, rehmannia, ophiopogon root, rhizoma anemarrhenae and achyranthes bidentata. The composition disclosed by the invention can be used for remarkably reducing the content of inflammatory factors of IL-6, IL-1beta and TNF-alpha in alveolar lavage fluid of a model rat with pneumonia caused by lipopolysaccharide, reducing the number of white blood cells and neutrophils of rat blood and increasing the percentage of lymphocytes and platelets, so that the traditional Chinese medicine composition has a relatively good treatment effect on pneumonia.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, relates to a new use of a traditional Chinese medicine composition, and particularly relates to the use of a traditional Chinese medicine composition in preparing a medicine for pneumonia. Background Art

[0002] Over the past few decades, pneumonia, a common respiratory disease, has become a major public health issue worldwide. Its etiology is diverse, including pathogens such as bacteria, viruses, and fungi. Clinical manifestations of pneumonia include cough, shortness of breath, chest pain, and high fever. In severe cases, it can lead to respiratory failure and even be life-threatening. While progress has been made in the treatment of pneumonia with the widespread use of antibiotics and antiviral drugs, drug resistance and the emergence of emerging pathogens still pose significant challenges to its prevention and treatment.

[0003] Bacterial pneumonia accounts for 80% of all pathogen-related pneumonia in adults and is a classic form of pneumonia, posing a significant health threat to children and the elderly. Symptoms of bacterial pneumonia vary widely, ranging from mild to severe, depending on the pathogen and host status. Common symptoms include cough and sputum production, or worsening of existing respiratory symptoms with purulent or bloody sputum, with or without chest pain.

[0004] Yunu Jian, a prescription recorded in the Jingyue Complete Works, is primarily used to clear the stomach and nourish yin. It treats water deficiency and excess fire, six pulses that are floating, surging, and slippery, characterized by Shaoyin deficiency and Yangming excess, restlessness, dryness, headache, toothache, and blood loss. It is currently used for acute stomatitis, glossitis, trigeminal neuralgia, and other conditions characterized by stomach heat and yin deficiency. There are no reports of its use in treating pneumonia. Summary of the Invention

[0005] To address the above technical problems, the present invention provides a use of a traditional Chinese medicine composition in the preparation of a medicament for pneumonia. The traditional Chinese medicine composition is prepared from gypsum, rehmannia root, ophiopogon japonicus, rhizoma anemarrhenae, and achyranthes bidentata. The use can be any method that is beneficial for improving the corresponding symptoms of the patient, including treatment or prevention. The pneumonia can be acute pneumonia or bacterial pneumonia.

[0006] The traditional Chinese medicine composition comprises: 1-100 parts of gypsum, 1-100 parts of rehmannia root, 1-100 parts of ophiopogon japonicus, 1-100 parts of anemarrhena rhizome, and 1-100 parts of achyranthes bidentata.

[0007] Furthermore, the traditional Chinese medicine composition comprises: 10 to 80 parts of gypsum, 10 to 80 parts of rehmannia root, 10 to 80 parts of ophiopogon japonicus, 10 to 80 parts of anemarrhena rhizome, and 10 to 80 parts of achyranthes bidentata.

[0008] Preferably, the traditional Chinese medicine composition comprises: 10-60 parts of gypsum, 10-80 parts of rehmannia root, 10-50 parts of ophiopogon japonicus, 10-20 parts of anemarrhena asphodeloides, and 10-20 parts of achyranthes bidentata.

[0009] Preferably, the traditional Chinese medicine composition comprises: 30-35 parts of gypsum, 50-55 parts of rehmannia root, 15-18 parts of ophiopogon japonicus, 12-15 parts of anemarrhena rhizome, and 12-15 parts of achyranthes bidentata.

[0010] The above composition can be directly ground into powder and mixed by raw materials, or can be an extract or other form prepared by conventional means. The raw materials used can also be used in the form of direct grinding into powder, extract, or other processed forms.

[0011] Specifically, the pharmaceutical dosage forms of the pneumonia medicine provided by the present invention include oral dosage forms, injection dosage forms or external dosage forms.

[0012] The dosage forms of the drugs of the present invention are prepared by weighing the raw materials in proportion, adding pharmaceutically acceptable excipients or additives, such as fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, bases, etc., and preparing them according to conventional production methods in the pharmaceutical field to prepare conventional pharmaceutically acceptable dosage forms, including but not limited to decoctions, granules, capsules, tablets, oral liquids, pills, tinctures, syrups, suppositories, gels, sprays, and injections.

[0013] Furthermore, the preparation method of the aforementioned traditional Chinese medicine composition is as follows: gypsum, rehmannia root, ophiopogon japonicus, anemarrhena asphodeloides, and cyperus rotundus are extracted by reflux with water, filtered, the filtrate is concentrated to an extract, dried, crushed into fine powder, and mixed to obtain spray-dried fine powder.

[0014] More preferably, the preparation method of the aforementioned drug is as follows: add 6 times the amount of water to the five medicinal materials of gypsum, Rehmannia, Ophiopogon japonicus, Anemarrhena asphodeloides, and Achyranthes bidentata, soak for 30 minutes, reflux extraction for 60 minutes, filter, concentrate the filtrate to an extract with a relative density of 1.05-1.10 (60-70°C), spray dry, grind into fine powder, mix to obtain spray-dried fine powder, add an appropriate amount of dextrin and 5g of stevioside, and granulate to obtain the product.

[0015] The traditional Chinese medicine composition proposed in this invention can significantly reduce the levels of inflammatory factors such as IL-6, IL-1β, and TNF-α in the bronchoalveolar lavage fluid of rats with lipopolysaccharide-induced pneumonia, reduce the white blood cell count and neutrophil count in the rats' blood, and increase the percentage of lymphocytes and platelets, suggesting that it has the effect of inhibiting the body's inflammatory response, clearing antigens, and promoting the body's recovery. Therefore, the traditional Chinese medicine composition of this invention has a certain therapeutic effect on pneumonia. DETAILED DESCRIPTION

[0016] The present application aims to provide an application of a Chinese medicine composition in the preparation of a medicine for treating or preventing pneumonia. In order to enable those skilled in the art to more clearly understand the technical solution of the present application, the technical solution of the present application will be described in detail below in conjunction with specific examples. If the specific conditions are not specified in the following experiments, they are all carried out in accordance with conventional conditions or the conditions recommended by the manufacturer. The raw materials or excipients used, as well as the reagents or instruments used, for which the manufacturer is not specified, are all conventional products that can be obtained commercially. The experimental methods for which the detailed conditions are not specified are carried out in accordance with conventional test methods or in accordance with the operating instructions recommended by the supplier.

[0017] It should be noted that the following detailed description is illustrative and is intended to provide further explanation of the present application. Unless otherwise specified, all technical and scientific terms used herein have the same meanings as those commonly understood by those of ordinary skill in the art to which this application belongs. The following examples are intended only to further illustrate the technical solutions of the present application and are not intended to limit the scope of protection of the present application.

[0018] Example 1 Preparation of Chinese medicine composition

[0019] Take 932.50g of gypsum, 1515.63g of Rehmannia root, 466.25g of Ophiopogon japonicus, 350.00g of Anemarrhena asphodeloides and 350.00g of Achyranthes bidentata, add 6 times the amount of water, soak for 30 minutes, reflux extraction for 60 minutes, filter, concentrate the filtrate to an extract with a relative density of 1.05-1.10 (60-70°C), spray dry, grind into fine powder, mix the whole to obtain a spray-dried fine powder to obtain a traditional Chinese medicine composition intermediate, add an appropriate amount of dextrin and 5g of stevioside, granulate, and make 1000g.

[0020] Example 2 Effects of LPS-induced Pneumonia in SD Rats

[0021] 1. Experimental Materials

[0022] Animals: 60 SD rats, SPF grade, male, 6 weeks old, weighing 170-190 g, purchased from Sibeifu (Suzhou) Biotechnology Co., Ltd., certificate number: NO.202406087.

[0023] Drugs: Dexamethasone acetate tablets (batch number 2301142) provided by Anhui Golden Sun Biochemical Pharmaceutical Co., Ltd.; Chinese medicine composition provided by Jiangsu Kangyuan Pharmaceutical Co., Ltd.

[0024] Reagents: LPS: SIGMA, extracted from Escherichia coli O55:B5, batch number O00235218; dexamethasone acetate tablets, Anhui Golden Sun Biochemical Pharmaceutical Co., Ltd., batch number 2301032; IL-1β kit (item number H002-1-1), TNF-α kit (item number H052-1-1), IL-6 kit (item number H007-1-1), all products of Nanjing Jiancheng Bioengineering Research Institute.

[0025] Instruments: MULITSKAN Sky microplate reader (Thermo Fisher Scientific, USA), MINIP-2500 microplate centrifuge, MINI-4K microcentrifuge (Hangzhou Miou Instrument Co., Ltd.), 5418R low-temperature high-speed centrifuge (Eppendorf, Germany), fully automatic modular animal blood and body fluid analyzer Sysmex XN-1000, Sysmex Medical Electronics (Shanghai) Co., Ltd.

[0026] 2. Dosage design

[0027] The daily dose of dexamethasone acetate tablets for humans is 0.75 mg, and the clinical dose for adults (calculated based on 60 kg) is 0.0125 mg / kg. The calculated equivalent dose for rats is 0.0775 mg / kg.

[0028] The daily dose of the Chinese medicine composition is 57.83g of crude drug, and the clinical dose for an adult (60kg) is 0.96g / kg. The calculated rat equivalent dose is 5.97g / kg. Using this dose as the median dose, and using a 0.5:1:2 dose ratio, the low, medium, and high doses of the Chinese medicine composition are 2.99, 5.97, and 11.95g of crude drug / kg, respectively.

[0029] 3. Experimental Methods

[0030] Sixty SD rats were randomly divided into six groups, with 10 rats in each group, namely blank group, model group, positive control group, and low-, medium-, and high-dose groups of the Chinese medicine composition. Except for the blank and model groups, which were given the same volume of pure water, the other groups were gavage-treated for 2 consecutive days. One hour after the last dose, 0.35g / kg of 10% chloral hydrate was injected intraperitoneally for anesthesia. After anesthesia, the rats were placed on a 45° flat plate. The tongue of the rat was pulled with forceps, and 80μL of 5mg / kg LPS was pipetted and dripped onto the posterior wall of the rat's oral pharynx. The rat's nose was immediately pinched. After 20 seconds, the tongue and nose were released, and the appearance of mild tracheal rales indicated a successful model. Drug administration continued for 3 days after model establishment.

[0031] Detection criteria: ① Rats were anesthetized with 0.35 g / kg of 10% chloral hydrate, and 2 mL of blood was collected from the abdominal aorta. White blood cell (WBC) counts were performed using a Sysmex hematology analyzer. ② The cervical trachea was surgically isolated and intubated, the thoracic cavity was exposed, the right lung lobe was ligated, and the left lung was lavaged three times with 1 mL of phosphate-buffered saline (PBS, pH 7.4). Each lavage was allowed to rest for 30 seconds. The lavage fluid was combined, 1 mL of the sample was centrifuged (1000 rpm for 10 minutes), and the supernatant was frozen at -20°C. IL-6, IL-1β, and TNF-α levels were determined according to the ELISA kit instructions.

[0032] 4. Experimental Results

[0033] General Condition: Rats in the blank group were in good condition, with normal activity, shiny fur, normal breathing, and a normal diet. Rats in the model group developed runny nose, decreased activity, weight loss, rapid breathing, dull fur, and piloerection. Some rats developed redness in the nose, and in severe cases, pink discharge. After three days of treatment, the different treatment groups performed better than the model group, especially those in the medium and high doses of the Chinese medicine composition, which showed increased activity and more sensitive reactions.

[0034] Levels of inflammatory factors in bronchoalveolar lavage fluid: Compared with the normal group, the levels of IL-6, IL-1β, and TNF-α in the model group were significantly increased (P < 0.01). Compared with the model group, the levels of IL-6, IL-1β, and TNF-α in the positive group and the high-dose TCM composition group were significantly decreased (P < 0.01). The levels of IL-6 and IL-1β in the low-dose and medium-dose TCM composition groups were significantly decreased (P < 0.05, P < 0.01, respectively). See Table 1 for details.

[0035] Table 1 Comparison of inflammatory factor expression in BALF of each group (ng / L, )

[0036]

[0037] Note: Compared with the blank control group, * P<0.05, ** P<0.01. Compared with the model group # P<0.05, ## P<0.01.

[0038] In terms of rat white blood cell counts, compared with the blank group, the model group showed significantly increased WBC (white blood cell count) and NE (neutrophil) levels (P < 0.01), while significantly decreased LY% (lymphocyte percentage) and PLT (platelet) levels (P < 0.05, P < 0.01). Compared with the model group, the WBC and NE levels in the medium- and high-dose groups of the Chinese medicine composition significantly decreased (P < 0.01), while the WBC level in the low-dose group significantly decreased (P < 0.05). LY% and PLT levels in the high-dose group significantly increased (P < 0.01), while LY% levels in the low- and medium-dose groups significantly increased (P < 0.05, P < 0.01). See Table 2 for details.

[0039] Table 2 Effects on rat blood leukocyte count

[0040]

[0041]

[0042] Note: Compared with the blank control group, * P<0.05, ** P<0.01. Compared with the model group # P<0.05, ## P<0.01.

[0043] The traditional Chinese medicine composition proposed in this invention can significantly reduce the levels of inflammatory factors such as IL-6, IL-1β, and TNF-α in the bronchoalveolar lavage fluid of rats with lipopolysaccharide-induced pneumonia, reduce the white blood cell count and neutrophil count in the rats' blood, and increase the percentage of lymphocytes and platelets, suggesting that it has the effect of inhibiting the body's inflammatory response, clearing antigens, and promoting the body's recovery. Therefore, the traditional Chinese medicine composition of this invention has a certain therapeutic effect on bacterial pneumonia or acute pneumonia.

[0044] The above embodiments of the present invention are merely examples for the purpose of clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. Those skilled in the art will appreciate that other variations or modifications may be made based on the above description. It is not necessary and impossible to enumerate all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the claims of the present invention.

Claims

1. Use of a Chinese medicine composition in preparing a medicine for pneumonia, characterized in that: The traditional Chinese medicine composition is prepared from the following components by weight: 1-100 parts of gypsum, 1-100 parts of rehmannia root, 1-100 parts of ophiopogon japonicus, 1-100 parts of anemarrhena rhizome, and 1-100 parts of achyranthes bidentata.

2. The use according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following components: 10-80 parts of gypsum, 10-80 parts of rehmannia root, 10-80 parts of ophiopogon japonicus, 10-80 parts of anemarrhena rhizome, and 10-80 parts of achyranthes bidentata.

3. The use according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following components: 10-60 parts of gypsum, 10-80 parts of rehmannia root, 10-50 parts of ophiopogon japonicus, 10-20 parts of anemarrhena rhizome, and 10-20 parts of achyranthes bidentata.

4. The use according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following components: 30-35 parts of gypsum, 50-55 parts of rehmannia root, 15-18 parts of ophiopogon japonicus, 12-15 parts of anemarrhena rhizome, and 12-15 parts of achyranthes bidentata.

5. The use according to claim 1, characterized in that The preparation method of the traditional Chinese medicine composition is as follows: gypsum, rehmannia root, ophiopogon japonicus, rhizoma anemarrhenae and achyranthes bidentata are extracted by reflux with water, filtered, the filtrate is concentrated to an extract, dried, crushed into fine powder, and mixed to obtain spray-dried fine powder.

6. The use according to claim 1, characterized in that The preparation method of the medicine is as follows: add 6 times the amount of water to five medicinal materials, including gypsum, rehmannia, ophiopogon, anemarrhena, and achyranthes, soak for 30 minutes, reflux extraction for 60 minutes, filter, concentrate the filtrate to an extract with a relative density of 1.05-1.10 (60-70° C.), spray dry, grind into fine powder, mix to obtain spray-dried fine powder, add an appropriate amount of dextrin and 5g of stevioside, and granulate to obtain the medicine.

7. The use according to any one of claims 1 to 4, characterized in that: The medicine further includes pharmaceutically acceptable excipients or additives.

8. The use according to claim 7, characterized in that The dosage form of the pneumonia medicine includes an oral dosage form, an injection dosage form or an external dosage form.

9. The use according to claim 8, characterized in that The medicines for pneumonia include decoctions, granules, capsules, tablets, oral liquids, pills, tinctures, syrups, gels, sprays, and injections.

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