Traditional Chinese medicine composition with effects of tonifying qi and eliminating dampness and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition with effects of tonifying qi and eliminating dampness and application of the traditional Chinese medicine composition. The invention provides a novel application of a known traditional Chinese medicine composition for blocking transformation of colitis cancer in preparation of a medicine for treating cough. The invention also obtains a new traditional Chinese medicine composition through improvement on the basis of the formula, and the traditional Chinese medicine composition not only has an antitussive effect, but also has a good treatment effect on sticky phlegm accompanied by cough caused by respiratory tract infection, chronic obstructive pulmonary disease, pharyngitis and bronchitis.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine and new uses, and specifically relates to a traditional Chinese medicine composition with qi-invigorating and dampness-drying effects and an application thereof. Background Art

[0002] Cough is a common clinical symptom, often caused by various respiratory diseases. As early as the Tai-Han period, the Yellow Emperor's Classic of Internal Medicine proposed the name of cough, and made a detailed discussion of its clinical manifestations, etiology, pathogenesis, and treatment outcomes. The article pointed out that "all the internal organs can cause cough, not just the lungs", that is, external evil invades the lungs and causes cough, and dysfunction of other internal organs affects the lungs and can also cause cough. At present, modern medicine has no specific treatment for cough. Long-term coughing will not only affect the patient's work and life, but also have an adverse effect on the patient's psychology.

[0003] Sputum is a common symptom of respiratory complications, often accompanying respiratory infections, chronic obstructive pulmonary disease, pharyngitis and bronchitis. Modern Chinese medicine practitioners generally believe that the pathogenesis of cough is a combination of deficiency of the root and excess of the symptoms. The root deficiency is lung and spleen deficiency, and the excess of the symptoms is phlegm, water retention and blood stasis. Phlegm and stasis are the main pathological products, and the deficiency of the internal organs and pathological products interact with each other and affect each other to cause disease. Sputum can aggravate cough and lead to sputum retention, increase the risk of severe pneumonia and complications, and seriously affect the clinical outcome and quality of life of patients.

[0004] CN114886935A discloses a Chinese medicine composition for blocking the transformation of colitis into cancer, which can effectively relieve the inflammatory response of the intestinal mucosa and fundamentally reverse the "inflammation-cancer transformation" process of chronic enteritis. It can be widely used in the treatment of acute and chronic enteritis, ulcerative colitis, Crohn's disease and other colitis-related colon cancers. There are no reports on its therapeutic effect on cough. Summary of the invention

[0005] The first purpose of the present invention is to provide a new application of a known traditional Chinese medicine composition for blocking the transformation of colitis into cancer in the preparation of a medicine for treating cough; the traditional Chinese medicine composition is composed of the following medicinal ingredients in parts by weight: 9-30 parts of Pseudostellariae Radix, 3-9 parts of Atractylodes macrocephala, 3-10 parts of Ligusticum chuanxiong, 6-15 parts of Honeysuckle, 9-15 parts of Dalbergia odorifera, and 3-10 parts of Nutmeg.

[0006] As a specific embodiment of the present invention, the Chinese medicine composition is composed of the following medicinal ingredients in parts by weight: 12 parts of Pseudostellariae Radix, 8 parts of Atractylodes lancea, 6 parts of Ligusticum chuanxiong, 15 parts of Honeysuckle, 8 parts of Dalbergia odorifera, and 4 parts of Nutmeg.

[0007] In the above application, the cough is a dry cough or a cough without sputum symptoms.

[0008] The second object of the present invention is to provide a traditional Chinese medicine composition, comprising the following medicinal ingredients in parts by weight: 11-13 parts of Pseudostellariae Radix, 7-9 parts of Atractylodes lancea, 5-7 parts of Ligusticum chuanxiong, 14-16 parts of Honeysuckle, 7-9 parts of Dalbergia odorifera, 7-9 parts of Atractylodes macrocephala, and 5-7 parts of Pinellia ternata.

[0009] Preferably, the traditional Chinese medicine composition comprises the following medicinal flavors in parts by weight: 11-13 parts of Pseudostellariae Radix, 7-9 parts of Atractylodes lancea, 5-7 parts of Ligusticum chuanxiong, 14-16 parts of Honeysuckle, 7-9 parts of Dalbergia odorifera, 9-11 parts of Nutmeg, 7-9 parts of Atractylodes macrocephala, 9-11 parts of Bitter Apricot, and 5-7 parts of Pinellia.

[0010] As a specific embodiment of the present invention, the Chinese medicine composition is composed of the following medicinal ingredients in parts by weight: 12g of Pseudostellariae Radix, 8g of Atractylodes lancea, 6g of Ligusticum chuanxiong, 15g of Honeysuckle, 8g of Dalbergia odorifera, 10g of Nutmeg, 8g of Atractylodes macrocephala, 10g of Bitter Apricot, and 6g of Pinellia.

[0011] The prescription of the above Chinese medicine composition is explained as follows: Radix Pseudostellariae and Atractylodes macrocephala can invigorate the spleen and replenish qi, tonify the middle and strengthen the foundation, and are the main drugs; Pinellia tuber can dry dampness and resolve phlegm, bitter almond can relieve cough and asthma, and cardamom can warm the middle and promote water circulation, and are used to treat qi deficiency cough and asthma caused by lung and spleen deficiency, and phlegm and heat accumulation, and are the ministerial drugs; honeysuckle and baicalin can clear away heat and detoxify, and Atractylodes macrocephala, Dalbergia odorifera, and Ligusticum chuanxiong can wake up the spleen and disperse stagnation, regulate qi and activate collaterals, and are the adjuvant drugs; according to the theory that the lung and large intestine are exterior and interior, cardamom and bitter almond are reused in the improved prescription to take their effects of warming the middle and promoting water circulation, moistening the intestines and relieving constipation, and unblocking qi. The prescription strengthens the spleen and eliminates dampness to eliminate the source of phlegm, resolves phlegm and relieves cough to eliminate the phlegm that has been generated, and at the same time takes into account the effects of regulating qi, clearing heat, and dispersing cold, so that phlegm and dampness can be transformed, qi can be regulated, and lung qi can be promoted, so that the symptoms of cough with phlegm can be eliminated.

[0012] The third object of the present invention is to provide a traditional Chinese medicine extract, which is obtained by extracting the following medicinal flavors in parts by weight: 11-13 parts of Pseudostellariae Radix, 7-9 parts of Atractylodes lancea, 5-7 parts of Ligusticum chuanxiong, 14-16 parts of Honeysuckle, 7-9 parts of Dalbergia odorifera, 7-9 parts of Atractylodes macrocephala, and 5-7 parts of Pinellia ternata.

[0013] The medicinal flavors also include nutmeg and bitter almonds. The Chinese medicine extract is obtained by extracting the following medicinal flavors in parts by weight: 11-13 parts of Pseudostellariae Radix, 7-9 parts of Atractylodes macrocephala, 5-7 parts of Ligusticum chuanxiong, 14-16 parts of Honeysuckle, 7-9 parts of Dalbergia odorifera, 9-11 parts of nutmeg, 7-9 parts of Atractylodes macrocephala, 9-11 parts of bitter almonds, and 5-7 parts of Pinellia tuber.

[0014] The extraction is carried out according to the following operation: weigh each medicinal ingredient according to the ratio, add 10 times the amount of water, boil twice, each time for 1 hour, and combine the filtrate to obtain the product.

[0015] The fourth object of the present invention is to provide a Chinese medicine preparation, comprising the above-mentioned Chinese medicine composition or Chinese medicine extract.

[0016] The dosage forms of the Chinese medicine preparation include: decoction, pills, powders, granules and capsules.

[0017] The fifth object of the present invention is to provide the use of the above-mentioned Chinese medicine composition, Chinese medicine extract or Chinese medicine preparation in the preparation of a medicine for treating cough.

[0018] In the above application, the cough is a cough caused by respiratory tract infection, chronic obstructive pulmonary disease, pharyngitis and bronchitis.

[0019] In the above application, the method of taking the Chinese medicine composition, Chinese medicine extract or Chinese medicine preparation is: one dose per day for adults, once in the morning and once in the evening, and one week is a course of treatment.

[0020] Compared with the prior art, the present invention has the following beneficial effects: The present invention has found in clinical trials that the existing Chinese medicine composition for blocking the transformation of colitis into cancer has an antitussive effect and has a significant therapeutic effect on dry cough and cough without phlegm.

[0021] The invention is guided by the basic theories of traditional Chinese medicine, and according to the pathogenesis of cough and phlegm, Chinese medicine is combined to improve the prescription. On the basis of the prescription, white atractylodes, apricot kernel and pinellia are combined. The obtained composition not only has an antitussive effect, but also has a good therapeutic effect on cough accompanied by phlegm caused by respiratory tract infection, chronic obstructive pulmonary disease, pharyngitis and bronchitis. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 are the patient symptom scores (mean ± SD) in the single-drug group and the combination drug group (TCM composition A + single drug).

[0023] Figure 2 These are the pathological sections of rat lung tissue corresponding to different groups; A: blank control group; B: model control group; C: positive drug group; D: Chinese medicine composition A group; E: Chinese medicine composition B group; F: Chinese medicine composition C group.

[0024] Figure 3 The LCQ scores of patients in the positive drug group and the Chinese medicine composition group B (mean ± SD). DETAILED DESCRIPTION

[0025] The present invention will be further described below in conjunction with specific embodiments, but the present invention is not limited to the following embodiments.

[0026] Unless otherwise specified, the experimental methods used in the following examples are conventional methods.

[0027] Unless otherwise specified, the reagents, materials, instruments, etc. used in the following examples can be obtained from commercial sources.

[0028] Example 1 The Chinese medicine composition A granules have the following formula: 12g of Pseudostellariae Radix, 8g of Atractylodes macrocephala, 6g of Ligusticum chuanxiong, 15g of Honeysuckle, 8g of Dalbergia odorifera, and 4g of Nutmeg.

[0029] Example 2 The Chinese medicine composition B granules have the following formula: 12g of Pseudostellariae Radix, 8g of Atractylodes lancea, 6g of Ligusticum chuanxiong, 15g of Honeysuckle, 8g of Dalbergia odorifera, 10g of Nutmeg, 8g of Atractylodes macrocephala, 10g of Bitter Apricot kernel, and 6g of Pinellia ternata.

[0030] Example 3 The Chinese medicine composition C granules have the following formula: 12g of Pseudostellariae Radix, 8g of Atractylodes lancea, 6g of Ligusticum chuanxiong, 15g of Honeysuckle, 8g of Dalbergia odorifera, 8g of Atractylodes macrocephala, and 6g of Pinellia ternata.

[0031] The Chinese medicine compositions described in Example 1, Example 2, and Example 3 can be prepared according to the following operation: weigh the above formula by weight, add 10 times the amount of water, decoct twice, each time for 1 hour, combine the filtrate, dry at 60°C, and then crush for later use.

[0032] Experimental Example 1: Clinical Observation of Chinese Medicine Composition A A total of 56 patients with respiratory tract infection and cough treated in the Second Affiliated Hospital of Shandong Medical University were enrolled and divided into a single-drug group (28 cases) and a combined drug group (28 cases).

[0033] Single-drug group: given Feili Ke mixture (Guizhou Jianxing Pharmaceutical Co., Ltd.), oral, 3 times / day, 20ml / time.

[0034] Combined medication group: In addition to the Feili Ke mixture, the Chinese medicine composition A granules were administered orally, twice a day, one dose of 53g per day, for 7 consecutive days.

[0035] Before treatment and 7 days after treatment, according to the "Guidelines for Clinical Research of New Chinese Medicines (Trial)", symptoms such as cough, sputum, sore throat, sputum, exertion, spontaneous sweating, chest tightness and shortness of breath were scored 0 to 3 points according to the severity of none, mild, poisoning and severe, and the score was positively correlated with the severity of the symptoms.

[0036] The results show that: Figure 1 As shown, before treatment, there was no significant difference in the symptom scores between the single-drug group and the combined-drug group; but after 7 days of treatment, the symptom scores of both the single-drug group and the combined-drug group decreased significantly; and compared with the single-drug group, the symptom score of the combined-drug group was significantly lower than that of the single-drug group, indicating that the Chinese medicine composition A and the Feili Ke mixture have a synergistic therapeutic effect. At the same time, it was found that although the cough, sore throat, chest tightness and other symptoms of the patients who took the Chinese medicine composition A for one week were significantly improved, they still had sputum and expectoration, so the formula of the Chinese medicine composition A was improved so that it could treat cough and expectoration at the same time.

[0037] Experimental Example 2: Experiment on the expectorant effect of Chinese medicine composition 1 Materials and methods 1.1 Experimental animals Thirty-six SPF male Wistar rats, 10-12 weeks old, with an initial body weight of 200-250 g, were purchased from Sibeifu (Beijing) Biotechnology Co., Ltd. The selected animals were kept at room temperature of 18-25°C, relative humidity of 50%-60%, and 12-hour day and night alternation.

[0038] 1.2 Reagents and drugs (1) Modeling inducer: Flue-cured Daqianmen brand cigarettes, tar content 12 mg, smoke carbon monoxide content 14 mg, smoke nicotine content 0.9 mg.

[0039] (2) Drugs: Chinese medicine composition A: Pseudostellariae Radix 12g, Atractylodes lancea 8g, Ligusticum chuanxiong 6g, Honeysuckle 15g, Dalbergia odorifera 8g, and Nutmeg 4g.

[0040] Chinese medicine composition B: Pseudostellariae Radix 12g, Atractylodes lancea 8g, Ligusticum chuanxiong 6g, Honeysuckle 15g, Dalbergia odorifera 8g, Nutmeg 10g, Atractylodes macrocephala 8g, Bitter Apricot kernel 10g, Pinellia 6g.

[0041] Chinese medicine composition C: Radix Pseudostellariae 12g, Rhizoma Atractylodis Macrocephalae 8g, Rhizoma Chuanxiong 6g, Flos Lonicerae 15g, Radix Dalbergiae Odoriferae 8g, Rhizoma Atractylodis Macrocephalae 8g, Rhizoma Pinelliae 6g. Compared with Chinese medicine composition B, nutmeg and bitter almond are reduced.

[0042] The preparation of Chinese medicine composition A, Chinese medicine composition B and Chinese medicine composition C was carried out according to the following operation: weigh the above formula according to weight, add 10 times the amount of water and boil twice, each time for 1 hour, combine the filtrate, dry at 60°C, and then crush for later use.

[0043] Positive drug: Carbocysteine, which is commonly used in clinical practice, produced by Beijing Shuguang Pharmaceutical Co., Ltd.

[0044] 1.3 Main instruments, materials and reagents Sodium phenobarbital for injection, magnetic stirrer, OLYMPUS microscope, paraformaldehyde, adhesive slides and coverslips, xylene, etc.

[0045] 1.4 Establishment of animal model and grouping and drug administration The rats were adaptively fed for 7 days and randomly divided into a normal control group (without any stimulation), a model control group (only modeling, no drug administration), a positive drug group (administered carbocysteine) and three experimental groups (Chinese medicine composition group A, Chinese medicine composition group B, and Chinese medicine composition group C) according to their body weight using a random number table method, for a total of 6 groups, with 6 rats in each group.

[0046] According to the reference (Study on the mechanism of action of Jianpi Yifei Huatan prescription on airway mucus hypersecretion in COPD rats), the rat model of respiratory mucus hypersecretion was established by simple cigarette fumigation. Except for the normal control group, the rats in other groups were placed in a homemade passive smoking glass fumigation box (60cm*50cm*40cm), with ventilation holes on the top and both sides of the box. Daqianmen brand cigarettes were burned manually, and the smoke was introduced into the glass fumigation box by a three-way pipe. 12 Daqianmen cigarettes were burned at one time, and the smoke produced by each cigarette was about 1L, with a smoke concentration of about 5%, which lasted for 0.5 hours. Smoking was done twice a day, once in the morning and once in the afternoon, for 16 consecutive weeks.

[0047] After 12 weeks of simple fumigation, the three Chinese medicine combination groups were given corresponding drugs by gavage every morning and afternoon for 2 weeks, with a dosage of 50 ml / kg. The dosage of the positive drug group was 500 mg / kg. The normal control group and the model control group were given pure water by gavage every day, and the dosage was consistent with that of the treatment group.

[0048] 1.5 Experimental methods and results (1) Pulmonary function test Before sampling, rats were fasted but not watered for 24 hours. On the day of sampling, rats were anesthetized with 2% sodium pentobarbital injected intraperitoneally (0.2 mL / 100 g). The midline of the neck was incised and the trachea was exposed. The FVC (Forced Vital Capacity) and FEV (Forced Expiratory Volume) were measured using an experimental small animal pulmonary function tester: FEV200 / FVC was used to evaluate the lung function of rats.

[0049] The results showed that: as shown in Table 1, the lung tissue structure of the positive drug group and the three Chinese medicine combination groups were improved compared with the model control group, among which the effects of the positive drug group and Chinese medicine composition B were significantly better than those of the model control group, and the effect of Chinese medicine composition B was higher than that of the positive drug group.

[0050] Table 1 Comparison of lung function in rats of each group

[0051] Note: ** represents P<0.01 compared with the model control group, * represents P<0.05 compared with the model control group.

[0052] (2) Pathological observation: Lung tissues of rats in each group were obtained, stained with HE, and observed under a microscope.

[0053] The results show that: Figure 2As shown, in the lung tissue of the rats in the normal control group, the bronchial and alveolar mucosa were intact and normal in structure; in the lung tissue of the rats in the model control group, the bronchial and alveolar mucosa were incomplete, inflammatory cell infiltration and congestion were found in the tube wall, bronchial smooth muscle thickening, and alveolar structure disorder; while the lung tissue structure of the positive control group and the three Chinese medicine combination groups was improved compared with the model control group, and the effect of Chinese medicine combination B was significantly better than that of other groups.

[0054] Experimental Example 3: Clinical observation on the expectorant effect of Chinese medicine composition B Thirty-six patients with respiratory tract infection, cough and sputum treated in the Second Affiliated Hospital of Shandong Medical University were collected and divided into a Chinese medicine combination group (18 cases) and a positive drug group (18 cases). The positive drug group was given Feili Ke mixture (Guizhou Jianxing Pharmaceutical Co., Ltd.), orally, 3 times / day, 20ml / time; the Chinese medicine combination group was given Chinese medicine combination B formula granules, orally, 2 times / day, 1 set a day 83g, for 7 consecutive days.

[0055] (1) Pulmonary function indicators: Detect the forced expiratory volume in 1 second (FEV1) and calculate the ratio of FEV1 to forced vital capacity (FVC).

[0056] The results showed that: as shown in Table 2, there was no significant difference in FEV1 / FVC between the positive drug group and the Chinese medicine combination group before treatment. After treatment, the FEV1 / FVC of the Chinese medicine combination group was significantly higher than that of the positive drug group, indicating that the airway ventilation function of group B taking the Chinese medicine combination was significantly better than that of the positive drug group.

[0057] Table 2 Pulmonary function indexes before and after treatment

[0058] Note: ** represents P<0.01 compared with the positive drug group.

[0059] (2) Evaluation of patients' quality of life: Before treatment and 7 days after treatment, the patients' symptoms and quality of life were evaluated according to the Leicester Cough Quality of Life Questionnaire. The Leicester Cough Quality of Life Questionnaire (LCQ) scores the physiological, psychological and social functions of cough patients, and the scores are positively correlated with the quality of life.

[0060] The results show that: Figure 3 As shown, before treatment, there was no significant difference in LCQ scores between the positive drug group and the Chinese medicine composition group B; after 7 days of treatment, the LCQ scores of both the positive drug group and the Chinese medicine composition group B were significantly improved, and compared with the positive drug group, the LCQ score of the Chinese medicine composition group B was significantly increased.

[0061] Although the present invention has been described in detail above with general descriptions and specific embodiments, it is obvious to those skilled in the art that some modifications or improvements may be made thereto based on the present invention. Therefore, these modifications or improvements made without departing from the spirit of the present invention all fall within the scope of protection claimed by the present invention.

Claims

1. Application of a Chinese medicine composition in the preparation of a medicine for treating cough; The Chinese medicine composition is composed of the following medicinal ingredients in parts by weight: 9-30 parts of Pseudostellariae Radix, 3-9 parts of Atractylodes lancea, 3-10 parts of Ligusticum chuanxiong, 6-15 parts of Honeysuckle, 9-15 parts of Dalbergia odorifera, and 3-10 parts of Myristica fragrans.

2. The use according to claim 1, characterized in that: The cough is a dry cough or a cough without sputum symptoms.

3. A Chinese medicine composition comprising the following medicinal ingredients in parts by weight: 11-13 parts of Pseudostellariae Radix, 7-9 parts of Atractylodes lancea, 5-7 parts of Ligusticum chuanxiong, 14-16 parts of Honeysuckle, 7-9 parts of Dalbergia odorifera, 7-9 parts of Atractylodes macrocephala, and 5-7 parts of Pinellia ternata.

4. The Chinese medicine composition according to claim 3, characterized in that: The traditional Chinese medicine composition comprises the following medicinal ingredients in parts by weight: 11-13 parts of Pseudostellariae Radix, 7-9 parts of Atractylodes lancea, 5-7 parts of Ligusticum chuanxiong, 14-16 parts of Honeysuckle, 7-9 parts of Dalbergia odorifera, 9-11 parts of Myristica fragrans, 7-9 parts of Atractylodes macrocephala, 9-11 parts of Bitter Apricot kernel, and 5-7 parts of Pinellia ternata.

5. A Chinese medicine extract obtained by extracting the following medicinal ingredients in parts by weight: 11-13 parts of Pseudostellariae Radix, 7-9 parts of Atractylodes lancea, 5-7 parts of Ligusticum chuanxiong, 14-16 parts of Honeysuckle, 7-9 parts of Dalbergia odorifera, 7-9 parts of Atractylodes macrocephala, and 5-7 parts of Pinellia ternata.

6. The Chinese herbal medicine extract according to claim 5, characterized in that The invention is obtained by extracting the following medicinal ingredients in parts by weight: 11-13 parts of Pseudostellariae Radix, 7-9 parts of Atractylodes lancea, 5-7 parts of Ligusticum chuanxiong, 14-16 parts of Honeysuckle, 7-9 parts of Dalbergia odorifera, 9-11 parts of Myristica fragrans, 7-9 parts of Atractylodes macrocephala, 9-11 parts of Bitter Apricot kernel and 5-7 parts of Pinellia ternata.

7. A Chinese medicine preparation, comprising the Chinese medicine composition according to any one of claims 3-4 or the Chinese medicine extract according to any one of claims 5-6.

8. The Chinese medicine preparation according to claim 7, characterized in that: The dosage forms of the Chinese medicine preparation include: decoction, pills, powders, granules and capsules.

9. Use of the Chinese medicine composition according to any one of claims 3 to 4, the Chinese medicine extract according to any one of claims 5 to 6, or the Chinese medicine preparation according to any one of claims 7 to 8 in preparing a medicine for treating cough.

10. The use according to claim 9, characterized in that: The cough is caused by respiratory tract infection, chronic obstructive pulmonary disease, pharyngitis and bronchitis.

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