Use of traditional Chinese medicine composition in preparation of medicine for preventing and treating bronchitis

Abstract

This invention relates to the field of traditional Chinese medicine (TCM) technology, and particularly to the application of a TCM composition in the preparation of drugs for the prevention and treatment of bronchitis. The TCM composition of this invention is prepared from Magnolia biondii, Perilla frutescens, Schizonepeta tenuifolia, Angelica dahurica, Arctium lappa, Xanthium sibiricum, Schisandra chinensis, Pseudostellaria heterophylla, and Glycyrrhiza uralensis. The composition of this invention can increase sputum production in rats with smoke-induced bronchitis, reduce the levels of inflammatory factors IL-1β and IL-8 in sputum, and promote the excretion of phenol red from the bronchial segments of a mouse model of LPS-induced bronchitis, suggesting that this TCM composition has expectorant and anti-inflammatory effects and a good therapeutic effect on bronchitis.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to the application of traditional Chinese medicine compositions in the preparation of drugs for the prevention and treatment of bronchitis. Background Technology

[0002] Bronchitis is an inflammation of the trachea, bronchial mucosa, and surrounding tissues caused by various factors. The main symptoms are cough and sputum production. Recurrent viral and bacterial infections are common causes, while cold air, smoking, air pollution, and allergies can also trigger the condition.

[0003] Based on the onset and progression of the disease, bronchitis can be divided into two categories: ① Acute bronchitis, an acute inflammation of the tracheal and bronchial mucosa caused by biological, physical, chemical irritants, or allergies. It is mostly sporadic and has no epidemic tendency; the elderly and those with weakened immune systems are more susceptible. The main symptoms are cough and sputum production, often occurring in cold seasons or during sudden climate changes, and can also be caused by a prolonged acute upper respiratory tract infection; ② Chronic bronchitis, abbreviated as "CMB," is a chronic nonspecific inflammation of the tracheal and bronchial mucosa and surrounding tissues. Clinically, it is characterized by cough, sputum production, or wheezing as the main symptoms, and presents as a recurrent chronic process.

[0004] Acute bronchitis generally has a good prognosis, while chronic bronchitis is prone to becoming chronic and has a poor prognosis. Currently, the main treatment options for bronchitis include:

[0005] ① Treatment for acute bronchitis primarily focuses on anti-infective and antiviral therapies. Suitable medications include β-lactams (such as amoxicillin), macrolide antibiotics (such as azithromycin), and ribavirin granules for antiviral treatment. Additionally, acute bronchitis is often caused by biological, physical, or chemical irritants, or allergies; therefore, during treatment, doctors may also prescribe anti-allergy medications or other symptomatic treatments depending on the patient's specific condition. ② Treatment for chronic bronchitis is relatively complex. Chronic bronchitis often develops from unresolved acute bronchitis and can manifest as cough, sputum production, and sometimes wheezing, with episodes lasting more than three months annually for more than two consecutive years. For chronic bronchitis, if the cough produces white sputum and there are no obvious respiratory infection symptoms, doctors may only prescribe cough suppressants and expectorants. However, when patients with chronic bronchitis develop obvious respiratory infection symptoms, antibiotics are necessary.

[0006] It is evident that the treatment of both acute and chronic bronchitis involves the use of antibiotics and hormones, and the side effects of these drugs are always a problem that cannot be ignored. In recent years, with the deepening of medical research, the treatment of bronchitis has been constantly evolving. The field of traditional Chinese medicine should actively intervene in the prevention and treatment of bronchitis and develop appropriate prescriptions. Summary of the Invention

[0007] In view of this, the technical problem to be solved by the present invention is to provide the application of traditional Chinese medicine composition in the preparation of drugs for the prevention and treatment of bronchitis.

[0008] This invention provides the application of a traditional Chinese medicine composition in the preparation of a drug for the prevention and treatment of bronchitis.

[0009] In this invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 1-6 parts Magnolia biondii, 1-6 parts Perilla frutescens, 1-5 parts Schizonepeta tenuifolia, 1-5 parts Angelica dahurica, 1-5 parts Arctium lappa, 1-5 parts Xanthium sibiricum, 1-5 parts Schisandra chinensis, 1-6 parts Codonopsis pilosula, and 1-3 parts Glycyrrhiza uralensis.

[0010] In this invention, the prevention and treatment include: reducing cytokine levels and / or improving expectoration function.

[0011] In this embodiment of the invention, the cytokines are cytokines found in sputum.

[0012] Studies have shown that cytokines play a crucial role in the inflammatory process of bronchitis. For example, Th17 cytokines have been identified as major inflammatory cytokines involved in allergic bronchitis-asthma. During an allergic asthma attack, Th17 cells promote neutrophil recruitment to clear bacteria and fungi by producing IL-17. Furthermore, Th17 cells can also promote the secretion of IL-8 by tissue-resident cells through IL-17, further recruiting neutrophils to combat extracellular bacteria and parasites. Moreover, changes in cytokine levels can reflect the severity of bronchitis and the effectiveness of treatment. In this invention, the cytokines include IL-8 and / or IL-1β. Experiments have shown that after administration of the aforementioned traditional Chinese medicine composition, the levels of IL-1β and IL-8 in sputum were significantly reduced.

[0013] In patients with bronchitis, increased airway inflammation and mucus secretion may lead to impaired expectoration. The patient's expectoration ability can be assessed by measuring phenol red secretion or the length of expectorated sputum, thereby understanding the severity of the disease and the effectiveness of treatment. Experiments have shown that administration of the aforementioned traditional Chinese medicine composition significantly increased sputum length and phenol red secretion.

[0014] In this invention, the herbal composition can treat bronchitis caused by harmful gases. In some embodiments, the harmful gas is cigarette smoke.

[0015] In this invention, the effective dose of the traditional Chinese medicine composition is 46g of raw herbs per day.

[0016] In this invention, the preparation method of the traditional Chinese medicine composition includes:

[0017] The magnolia flower, perilla leaf, schizonepeta, and cocklebur fruit were mixed, soaked in water, distilled, and the volatile oil was extracted. Then, the volatile oil inclusion complex was prepared for later use. The remaining residue was boiled again, filtered, and the resulting decoction was combined and concentrated to obtain thick paste I.

[0018] The Codonopsis pilosula and Glycyrrhiza uralensis were mixed, decocted with water, filtered, and the resulting decoction was concentrated to obtain a thick paste II.

[0019] The Angelica dahurica, Arctium lappa, and Schisandra chinensis were mixed and extracted by reflux with ethanol. The obtained ethanol extract was concentrated to obtain a thick paste III.

[0020] After combining the three thick pastes I, II, and III, they were dried under reduced pressure and pulverized, and then the volatile oil inclusion complex was added and mixed evenly.

[0021] Furthermore, the present invention also provides a medicine for the prevention and treatment of bronchitis, comprising pharmaceutically acceptable excipients and the following raw materials in parts by weight: 1-6 parts Magnolia biondii, 1-6 parts Perilla frutescens, 1-5 parts Schizonepeta tenuifolia, 1-5 parts Angelica dahurica, 1-5 parts Arctium lappa, 1-5 parts Xanthium sibiricum, 1-5 parts Schisandra chinensis, 1-6 parts Pseudostellaria heterophylla, and 1-3 parts Glycyrrhiza uralensis.

[0022] The dosage forms of the drugs described in this invention include, but are not limited to, decoctions, granules, capsules, tablets, oral liquids, pills, tinctures, syrups, suppositories, gels, sprays, and / or injections.

[0023] In some embodiments provided by the present invention, the capsule is a hard capsule or a soft capsule.

[0024] In some embodiments provided by the present invention, the tablet is an oral tablet or a dental tablet.

[0025] Oral tablets refer to tablets intended for oral administration. Most of these tablets contain drugs that are absorbed through the gastrointestinal tract to exert their effects, while some contain drugs that exert their effects locally within the gastrointestinal tract. In some embodiments provided by this invention, the oral tablets are ordinary compressed tablets, dispersible tablets, effervescent tablets, chewable tablets, coated tablets, or sustained-release tablets.

[0026] The pharmaceutically acceptable excipients include one or more of the following: fruit powder, flavoring, sweetener, acidulant, filler, lubricant, preservative, suspending agent, food coloring, diluent, emulsifier, disintegrant, or plasticizer.

[0027] The medicament described in this invention also includes other bronchitis treatment agents, including antibiotics, antiviral drugs, and / or anti-allergy drugs.

[0028] The antibiotics include macrolide antibiotics, β-lactam antibiotics, aminoglycoside antibiotics, tetracycline antibiotics, or quinolone antibiotics. The penicillin antibiotics are at least one selected from ampicillin sodium, amoxicillin, and cephalosporin antibiotics (such as cefixime, cefaclor, ceftriaxone sodium, or cefuroxime sodium). The macrolide antibiotics are at least one selected from erythromycin, clarithromycin, roxithromycin, azithromycin, or lincomycin. The aminoglycoside antibiotics are at least one selected from gentamicin, kanamycin, amikacin, tobramycin, or ribosomycin. The tetracycline antibiotics are at least one selected from tetracycline, doxycycline, or oxytetracycline tablets. The quinolone antibiotics are at least one selected from levofloxacin hydrochloride, ciprofloxacin, norfloxacin, or moxifloxacin.

[0029] The antiviral drugs include: neuraminidase inhibitors, protease inhibitors or other antiviral drugs selected from at least one of oseltamivir, zanamivir, peramivir, arbidol, ribavirin, ganciclovir, amantadine, lopinavir or ritonavir.

[0030] The anti-allergy medication includes at least one of the following: antihistamines, glucocorticoids, allergy mediator blockers, calcium preparations, anti-5-hydroxytryptamine drugs, antikinin drugs, anti-fibrinolytic drugs, anti-complement drugs, anti-acetylcholine drugs, anti-lysosomal enzyme drugs, or anti-prostaglandin drugs. The antihistamine is loratadine, cetirizine, chlorpheniramine, or diphenhydramine. The glucocorticoid is prednisone or dexamethasone. The allergy mediator blocker is sodium cromoglycate or ketotifen. The calcium preparation is calcium gluconate or calcium chloride.

[0031] The traditional Chinese medicine composition of this invention is prepared from Magnolia biondii, Perilla frutescens, Schizonepeta tenuifolia, Angelica dahurica, Arctium lappa, Xanthium sibiricum, Schisandra chinensis, Pseudostellaria heterophylla, and Glycyrrhiza uralensis. This composition can increase sputum production in rats with smoke-induced bronchitis, reduce the levels of inflammatory factors IL-1β and IL-8 in sputum, and promote phenol red excretion in the bronchial segments of LPS-induced mouse bronchitis models, suggesting that this traditional Chinese medicine composition has expectorant and anti-inflammatory effects and a good therapeutic effect on bronchitis. Detailed Implementation

[0032] This invention provides the application of traditional Chinese medicine compositions in the preparation of drugs for the prevention and treatment of bronchitis. Those skilled in the art can refer to the content of this document and appropriately modify the process parameters to achieve the desired results. It should be particularly noted that all similar substitutions and modifications are obvious to those skilled in the art and are considered to be included in this invention. The methods and applications of this invention have been described through preferred embodiments. Those skilled in the art can obviously make modifications or appropriate alterations and combinations to the methods and applications described herein without departing from the content, spirit, and scope of this invention to realize and apply the technology of this invention.

[0033] This invention aims to provide the application of a traditional Chinese medicine composition in the preparation of drugs for treating or preventing bronchitis. The composition comprises: 1-6 parts Magnolia biondii, 1-6 parts Perilla frutescens, 1-5 parts Schizonepeta tenuifolia, 1-5 parts Angelica dahurica, 1-5 parts Arctium lappa, 1-5 parts Xanthium sibiricum, 1-5 parts Schisandra chinensis, 1-6 parts Pseudostellaria heterophylla, and 1-3 parts Glycyrrhiza uralensis. The composition of this invention can be directly ground into powder, or it can be an extract obtained through conventional methods in the art. The traditional Chinese medicine raw materials used in the composition of this invention can also be used by directly grinding into powder, extracting, or other processed forms.

[0034] Further, the composition comprises: 2-5 parts by weight of Magnolia biondii, 2-5 parts by weight of Perilla frutescens, 2-4 parts by weight of Schizonepeta tenuifolia, 2-4 parts by weight of Angelica dahurica, 2-4 parts by weight of Arctium lappa, 2-4 parts by weight of Xanthium sibiricum, 2-4 parts by weight of Schisandra chinensis, 2-5 parts by weight of Pseudostellaria heterophylla, and 1-2.5 parts by weight of raw Glycyrrhiza uralensis.

[0035] Further, the composition comprises: 3 parts by weight of Magnolia biondii, 3 parts by weight of Perilla frutescens, 2.5 parts by weight of Schizonepeta tenuifolia, 2.5 parts by weight of Angelica dahurica, 2.5 parts by weight of Arctium lappa, 2.5 parts by weight of Xanthium sibiricum, 2.5 parts by weight of Schisandra chinensis, 3 parts by weight of Pseudostellaria heterophylla, and 1.5 parts by weight of Glycyrrhiza uralensis.

[0036] Specifically, the aforementioned bronchitis medications include oral dosage forms, injectable dosage forms, or topical dosage forms.

[0037] The dosage form of the drug of the present invention is prepared by weighing the raw material in proportion, and then adding pharmaceutically acceptable excipients such as fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, and matrices during the preparation process, and preparing it according to conventional production methods in the pharmaceutical field to produce a pharmaceutically acceptable conventional dosage form, including but not limited to decoctions, granules, capsules, tablets, oral liquids, pills, tinctures, syrups, suppositories, gels, sprays, and injections.

[0038] The present invention also provides a method for preparing a bronchitis composition, the method comprising:

[0039] (1) Take the selected weight proportions of Magnolia biondii, Perilla frutescens, Schizonepeta tenuifolia, Xanthium sibiricum and Angelica dahurica, mix them with water and soak them, distill them to extract the volatile oil, add conventional excipients to make volatile oil inclusion complex, and set aside; continue to decoct the remaining residue, filter and combine the decoctions to concentrate to obtain thick paste I.

[0040] (2) Take the selected weight proportions of Codonopsis pilosula and raw licorice root, add water and decoct, filter and concentrate the decoction to obtain thick paste II;

[0041] (3) Take the selected weight proportions of burdock fruit and schisandra fruit, mix them and crush them into coarse powder, add ethanol and reflux to extract, and concentrate the obtained ethanol extract to obtain thick paste III;

[0042] (4) After combining the above-prepared thick paste I, thick paste II and thick paste III, dry them under reduced pressure and pulverize them, add the volatile oil inclusion complex prepared in step (1) above and mix well, add conventional excipients and prepare a clinically acceptable dosage form according to conventional process.

[0043] Furthermore, the aforementioned method for preparing the composition may include the following steps:

[0044] (1) Take the selected weight proportions of Magnolia biondii, Perilla frutescens, Schizonepeta tenuifolia and Xanthium sibiricum, add 10-15 times the weight of the drugs in water, soak for 1-3 hours, distill for 3-7 hours, extract the volatile oil, add conventional excipients to make volatile oil inclusion complex, and set aside; continue to decoct the remaining residue for 0.5-1.5 hours, filter and combine the decoctions and concentrate to a thick paste I with a relative density of 1.0-1.5;

[0045] (2) Take the selected weight proportions of Codonopsis pilosula and Glycyrrhiza uralensis, add 8-12 times the weight of the medicine in water, decoct 1-5 times, 1-5 hours each time, filter and concentrate the decoction to a thick paste II with a relative density of 1.0-1.5;

[0046] (3) Take the selected weight proportions of Angelica dahurica, Arctium lappa and Schisandra chinensis, mix them and crush them into coarse powder. Add 6-10 times the weight of the drug and 50-100% ethanol. Reflux and extract 1-3 times, 1-3 hours each time. Concentrate the obtained ethanol extract to a thick paste III with a relative density of 1.0-1.5.

[0047] (4) After combining the above-prepared thick paste I, thick paste II and thick paste III, dry them under reduced pressure and pulverize them, add the volatile oil inclusion complex prepared in step (1) above and mix well, add conventional excipients, and prepare a clinically acceptable dosage form according to conventional process.

[0048] Specifically, the preparation method of the aforementioned composition may include the following steps:

[0049] (1) Take the selected weight proportions of Magnolia biondii, Perilla frutescens, Schizonepeta tenuifolia and Xanthium sibiricum, add 12 times the weight of the drug in water, soak for 2 hours, distill for 5 hours, extract the volatile oil, add conventional excipients to make volatile oil inclusion complex, and set aside; continue to decoct the remaining residue for 1 hour, filter and combine the decoctions to concentrate to a thick paste I with a relative density of 1.30.

[0050] (2) Take the selected weight proportions of Codonopsis pilosula and Glycyrrhiza uralensis, add 10 times the weight of the medicine with water, decoct 3 times, 3 hours each time, filter and concentrate the decoction to a thick paste II with a relative density of 1.30;

[0051] (3) Take the selected weight proportions of Angelica dahurica, Arctium lappa and Schisandra chinensis, mix them and crush them into coarse powder. Add 8 times the weight of the drug and 70% ethanol. Reflux and extract twice, 2 hours each time. Concentrate the obtained ethanol extract to a thick paste III with a relative density of 1.30.

[0052] (4) After combining the above-prepared thick paste I, thick paste II and thick paste III, dry them under reduced pressure and pulverize them, add the volatile oil inclusion complex prepared in step (1) above and mix well, add conventional excipients and prepare a clinically acceptable dosage form according to conventional process.

[0053] The present invention also proposes a composition for treating or preventing bronchitis, characterized in that the composition comprises: 1-6 parts of Magnolia biondii, 1-6 parts of Perilla frutescens, 1-5 parts of Schizonepeta tenuifolia, 1-5 parts of Angelica dahurica, 1-5 parts of Arctium lappa, 1-5 parts of Xanthium sibiricum, 1-5 parts of Schisandra chinensis, 1-6 parts of Pseudostellaria heterophylla, and 1-3 parts of Glycyrrhiza uralensis.

[0054] Furthermore, the composition comprises: 2-5 parts of Magnolia biondii, 2-5 parts of Perilla frutescens, 2-4 parts of Schizonepeta tenuifolia, 2-4 parts of Angelica dahurica, 2-4 parts of Arctium lappa, 2-4 parts of Xanthium sibiricum, 2-4 parts of Schisandra chinensis, 2-5 parts of Pseudostellaria heterophylla, and 1-2.5 parts of raw Glycyrrhiza uralensis.

[0055] Furthermore, the composition comprises: 3 parts Magnolia biondii, 3 parts Perilla frutescens, 2.5 parts Schizonepeta tenuifolia, 2.5 parts Angelica dahurica, 2.5 parts Arctium lappa, 2.5 parts Xanthium sibiricum, 2.5 parts Schisandra chinensis, 3 parts Codonopsis pilosula, and 1.5 parts Glycyrrhiza uralensis.

[0056] The drug described in this invention can significantly increase the amount of sputum produced in rats with smoke-induced bronchitis, reduce the content of inflammatory factors IL-1β and IL-8 in sputum, and promote the secretion of phenol red in the bronchial segments of LPS-induced mouse bronchitis models. This suggests that the traditional Chinese medicine composition has expectorant and anti-inflammatory effects and has a good therapeutic effect on bronchitis.

[0057] The test materials used in this invention are all common commercial products and can be purchased on the market.

[0058] Unless otherwise specified, all experiments in the following experiments were conducted under standard conditions or conditions recommended by the manufacturer. Active pharmaceutical ingredients (APIs) or excipients, as well as reagents or instruments whose manufacturers are not specified, are all commercially available products. Unless otherwise stated, all percentages, ratios, proportions, or parts are by weight.

[0059] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as are familiar to those skilled in the art. Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to this invention.

[0060] The present invention will be further illustrated below with reference to the embodiments:

[0061] Example 1: Preparation of granules of the composition of the present invention

[0062] The composition of this invention is made from the following raw materials: 300g Magnolia biondii, 300g Perilla frutescens, 250g Schizonepeta tenuifolia, 250g Angelica dahurica, 250g Arctium lappa, 250g Xanthium sibiricum, 250g Schisandra chinensis, 300g Codonopsis pilosula, and 150g Glycyrrhiza uralensis.

[0063] The composition of the present invention is prepared according to the following method:

[0064] (1) Take the selected weight proportions of Magnolia biondii, Perilla frutescens, Schizonepeta tenuifolia and Xanthium sibiricum, add 12 times the weight of the drug in water, soak for 2 hours, distill for 5 hours, extract the volatile oil, add conventional excipients to make volatile oil inclusion complex, and set aside; continue to decoct the remaining residue for 1 hour, filter and combine the decoctions to concentrate to a thick paste I with a relative density of 1.30.

[0065] (2) Take the selected weight proportions of Codonopsis pilosula and Glycyrrhiza uralensis, add 10 times the weight of the medicine with water, decoct 3 times, 3 hours each time, filter and concentrate the decoction to a thick paste II with a relative density of 1.30;

[0066] (3) Take the selected weight proportions of Angelica dahurica, Arctium lappa and Schisandra chinensis, mix them and crush them into coarse powder. Add 8 times the weight of the drug and 70% ethanol. Reflux and extract twice, 2 hours each time. Concentrate the obtained ethanol extract to a thick paste III with a relative density of 1.30.

[0067] (4) Combine the thick paste I, thick paste II and thick paste III prepared above, dry under reduced pressure and pulverize, and add the volatile oil inclusion complex prepared in step (1) above and mix well to obtain the intermediate of the traditional Chinese medicine composition. Add an appropriate amount of conventional excipients and ethanol with a mass concentration of 80%, granulate, and obtain the final product.

[0068] Example 2: Effects of the Traditional Chinese Medicine Composition on a Rat Model of Bronchitis

[0069] 1. Experimental Materials

[0070] 1.1 Animals

[0071] Male SD rats, SPF grade, weighing 160-180g, were purchased from Spiefer (Beijing) Biotechnology Co., Ltd. Housing environment: room temperature 20-25℃, relative humidity controlled at 40%-70%, stocking density 5 rats / cage.

[0072] 1.2 Drugs and Reagents

[0073] The traditional Chinese medicine composition, the intermediate prepared according to the method of Example 1, is from Jiangsu Kangyuan Pharmaceutical Co., Ltd.; Yinhuang Qingfei Capsules (Hunan Anbang Pharmaceutical Co., Ltd., batch number: 220602); Furong brand cigarettes (produced by Hunan Changde Cigarette Factory, tar content: 11mg, nicotine content: 0.9mg, carbon monoxide content: 13mg); rat interleukin-1β (IL-1β, Elabscience, catalog number: E-EL-R0012); rat interleukin-8 (IL-8, Shanghai Enzyme-Linked Biotechnology Co., Ltd., catalog number: ml037351).

[0074] 1.3 Instruments

[0075] Electronic balance (Sartorius Scientific Instruments, model BS224S); Low-temperature centrifuge (Eppendorf, Germany, model 5804R); Animal weight scale (Shanghai Xiangchuan Electronic Weighing Instrument Co., Ltd., model: CX-SC-DA); Microplate reader (McGen, USA, model Flexstation 3).

[0076] 2. Dosage design

[0077] The daily dosage of the traditional Chinese medicine composition is 46g of raw drug / day. Based on the body surface area calculation method, the equivalent dose for rats is 46 / 60×6.2=4.8g of raw drug / kg. According to the 1 / 4:1 / 2:1 dosing method, the low dose is 1.2g of raw drug / kg and the medium dose is 2.4g of raw drug / kg.

[0078] The clinical daily dosage of Yinhuang Qingfei Capsules is 1.35g. Based on the body surface area calculation method, the equivalent dose for rats is 1.35g / 60kg × 6.2 = 0.14g / kg.

[0079] 3. Experimental Methods

[0080] Ninety SD rats were acclimatized for 5 days, and 10 rats (half male and half female) were used as a normal control group without treatment. The remaining rats were used to establish a rat bronchitis model using the fumigation method. The rats were placed in a self-made fumigation box (length, width, and height were 65.5 cm, 47.0 cm, and 37.5 cm, respectively). An automatic smoker was used to burn cigarettes at a rate of 5 min / cigarette, and the smoke was introduced into the fumigation box. Each fumigation lasted 30 minutes, once a day for 30 consecutive days. The rats were considered to have successfully established the model when they exhibited symptoms such as coughing and wheezing, nasal and oral secretions, reduced activity, and dull, yellowish fur.

[0081] Fifty rats that successfully developed the model were randomly divided into five groups: a model control group, a Yinhuang Qingfei capsule group, and low, medium, and high dose groups of the traditional Chinese medicine combination, with ten rats in each group. Each group received the corresponding drug via gavage at a dose of 10 mL / kg. The normal control group and the model control group received pure water via gavage once daily for 14 consecutive days. Except for the normal control group, all other groups continued to undergo fumigation.

[0082] The day after the last administration, rats in each group were anesthetized, and their neck skin was cut open to expose the trachea. A glass capillary tube with an inner diameter of 1.0 mm was then inserted into the trachea and placed close to the inner wall of the trachea. The length of sputum in the glass capillary tube was measured within 2 hours in each group of animals. The levels of IL-1β and IL-8 in the sputum were detected using an ELISA kit.

[0083] 4. Statistical Methods

[0084] The results were statistically analyzed using t-tests.

[0085] 5. Experimental Results

[0086] 5.1 Effects on sputum volume and IL-1β and IL-8 levels in sputum of rats with bronchitis

[0087] Compared with the normal control group, the sputum length in the model control group was significantly reduced, and the levels of IL-1β and IL-8 in the sputum were significantly increased. Compared with the model control group, the sputum length in the Yinhuang Qingfei capsule group and each dose group of the traditional Chinese medicine combination was significantly increased, and the levels of IL-1β and IL-8 in the sputum were significantly reduced (P<0.05, P<0.01). The results are shown in Table 1.

[0088] Table 1. Effects of sputum volume and IL-1β and IL-8 levels in sputum of rats in each group.

[0089]

[0090] Note: Compared with the normal control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0091] 6. Experimental Conclusions

[0092] The traditional Chinese medicine composition significantly increased sputum volume and significantly inhibited the content of inflammatory factors IL-1β and IL-8 in sputum, suggesting that the traditional Chinese medicine composition has certain expectorant and anti-inflammatory therapeutic effects on rats with smoke-induced bronchitis.

[0093] Example 3: Effect of the traditional Chinese medicine composition on phenol red excretion in bronchitis mice

[0094] 1. Experimental Materials

[0095] 1.1 Animals

[0096] Sixty ICR mice, half male and half female, SPF grade, weighing 18-21g, were purchased from the Comparative Medicine Center of Yangzhou University. Housing environment: room temperature 20-25℃, relative humidity controlled at 40%-70%, stocking density 5 mice / cage.

[0097] 1.2 Drugs and Reagents

[0098] The traditional Chinese medicine composition, the intermediate obtained by the method of Example 1, is from Jiangsu Kangyuan Pharmaceutical Co., Ltd.; Yinhuang Qingfei Capsules (Hunan Anbang Pharmaceutical Co., Ltd., batch number: 220602); sodium bicarbonate, phenol red (Sinopharm Chemical Reagent Co., Ltd.); lipopolysaccharide (LPS, Sigma-Aldrich, USA, catalog number L2630);

[0099] 1.3 Instruments

[0100] Electronic balance (Sartorius Scientific Instruments, model BS224S); animal weight scale (Shanghai Xiangchuan Electronic Weighing Instrument Co., Ltd., model: CX-SC-DA); microplate reader (American M.M ...

[0101] 2. Dosage design

[0102] The daily dosage of the traditional Chinese medicine composition is 46g of raw drug / day. Based on the body surface area conversion method, the equivalent dose for mice is 46 / 60×12.3=9.40g of raw drug / kg. According to the 1 / 4:1 / 2:1 dosing method, the low dose is 2.35g of raw drug / kg and the medium dose is 4.70g of raw drug / kg.

[0103] The clinical daily dosage of Yinhuang Qingfei Capsules is 1.35g. Based on the body surface area reduction method, the equivalent dose for mice is 1.35g / 60kg×12.3=0.28g / kg.

[0104] 3. Experimental Methods

[0105] After 3 days of acclimatization feeding, ICR mice were randomly divided into 6 groups according to body weight: a normal control group, a model control group, a Yinhuang Qingfei capsule group, and low, medium, and high dose groups of the traditional Chinese medicine combination, with 10 mice in each group (half male and half female). Mice were anesthetized with isoflurane and administered LPS solution (10 mg / kg) via nasal drops once daily for 3 consecutive days. For each drug group, administration via gavage began 2 hours after the first LPS nasal drop. The normal control and model control groups were administered pure water via gavage for 7 consecutive days, once daily. 30 minutes after the last administration, except for the normal control group which was injected with physiological saline, the other groups were injected intraperitoneally with 20 mL / kg of 5% phenol red solution. Mice were sacrificed 30 minutes later, and the trachea from the lower edge of the thyroid cartilage to the tracheal bifurcation was removed and placed in a test tube containing 3 mL of physiological saline. 20 μL of 0.1 mol / L sodium hydroxide solution was then added to adjust the pH. The absorbance at 545 nm was read using an ELISA reader, and the amount of phenol red secreted in the tracheal segment of each group of mice was calculated based on the phenol red standard curve.

[0106] 4. Statistical Methods

[0107] The results were statistically analyzed using t-tests.

[0108] 5. Experimental Results

[0109] 5.1 Effect on phenol red secretion in the tracheal segment of bronchitis mice

[0110] Compared with the normal control group, the amount of phenol red excreted by mice in the model control group was significantly reduced (P<0.01); compared with the model control group, the amount of phenol red excreted by each dose group of Yinhuang Qingfei capsules and traditional Chinese medicine composition was significantly increased (P<0.05, P<0.01). The results are shown in Table 2.

[0111] Table 2. Effects of phenol red excretion in the tracheal segment of bronchoalveolar mice

[0112]

[0113] Note: Compared with the normal control group, ## P<0.01; compared with the model control group, *P<0.05, **P<0.01.

[0114] 6. Experimental Conclusions

[0115] The traditional Chinese medicine composition can significantly increase the excretion of phenol red in mice with bronchitis, suggesting that the traditional Chinese medicine composition has an expectorant effect on the LPS-induced mouse bronchitis model and has a certain therapeutic effect.

[0116] The above are merely preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. Application of traditional Chinese medicine compositions in the preparation of drugs for the prevention and treatment of bronchitis; The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: Magnolia flower 1-6 parts, Perilla leaf 1-6 parts, Schizonepeta 1-5 parts, Angelica dahurica 1-5 parts, Burdock fruit 1-5 parts, Xanthium fruit 1-5 parts, Schisandra fruit 1-5 parts, Codonopsis pilosula 1-6 parts, and raw licorice root 1-3 parts.

2. The application according to claim 1, characterized in that, The prevention and treatment include: reducing cytokine levels and / or improving expectoration function.

3. The application according to claim 2, characterized in that, The cytokines include IL-8 and / or IL-1β.

4. The application according to claim 2, characterized in that, The cytokines mentioned are those found in sputum.

5. The application according to any one of claims 1 to 4, characterized in that, The bronchitis mentioned is a disease caused by harmful gases or lipopolysaccharides.

6. The application according to claim 5, characterized in that, The harmful gas is cigarette smoke.

7. The application according to claim 1, characterized in that, The preparation method of the traditional Chinese medicine composition includes: The magnolia flower, perilla leaf, schizonepeta, and cocklebur fruit were mixed, soaked in water, distilled, and the volatile oil was extracted. Then, the volatile oil inclusion complex was prepared for later use. The remaining residue was boiled again, filtered, and the resulting decoction was combined and concentrated to obtain thick paste I. The Codonopsis pilosula and Glycyrrhiza uralensis were mixed, decocted with water, filtered, and the resulting decoction was concentrated to obtain a thick paste II. The Angelica dahurica, Arctium lappa, and Schisandra chinensis were mixed and extracted by reflux with ethanol. The obtained ethanol extract was concentrated to obtain a thick paste III. After combining the thick pastes I, II, and III, they were dried under reduced pressure and pulverized, and then the volatile oil inclusion complex was added and mixed evenly.

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