A traditional Chinese medicine composition with the functions of supplementing qi and drying dampness and its application

Abstract

The present invention discloses a traditional Chinese medicine composition with the effects of replenishing qi and drying dampness and its application. The present invention provides a new application of a known traditional Chinese medicine composition for blocking the carcinogenic transformation of colitis in the preparation of a drug for treating cough. The present invention also obtains a new traditional Chinese medicine composition by improvement on the basis of this formula, which not only has a cough-relieving effect, but also has a good therapeutic effect on the sticky phlegm accompanied by cough caused by respiratory tract infection, chronic obstructive pulmonary disease, pharyngitis and bronchitis.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine and new uses, and particularly relates to a traditional Chinese medicine composition with the functions of replenishing qi and drying dampness and its application. Background Art

[0002] Cough is a common clinical symptom, often caused by various respiratory diseases. As early as in the Qin and Han dynasties, the "Huangdi Neijing" put forward the name of cough and made a detailed discussion on its clinical manifestations, etiology, pathogenesis, and syndrome treatment and prognosis. It is pointed out in the text that "all the five zang-organs and six fu-organs can cause cough, not only the lung", that is, exogenous pathogens invading the lung cause cough, and the dysfunction of other zang-organs can also affect the lung and cause cough. At present, modern medicine has no specific treatment method for cough. A long-term cough will not only affect the patient's work and life, but also have an adverse impact on the patient's psychology.

[0003] Viscous phlegm is a common complication of the respiratory tract, often accompanied by respiratory tract infections, chronic obstructive pulmonary disease, pharyngitis, and bronchitis. Modern traditional Chinese medicine experts generally believe that the pathogenesis of cough is deficiency in origin and excess in superficiality. The deficiency in origin is the deficiency of the lung and spleen qi, and the excess in superficiality is phlegm turbidity, retained fluid, and blood stasis; among them, phlegm and stasis are the main pathological products. The deficiency of the zang-organs and the pathological products interact with each other and affect each other to cause disease. Viscous phlegm will aggravate cough and cause sputum retention, increasing the risk of severe pneumonia and complications, seriously affecting the patient's clinical outcome and quality of life.

[0004] CN114886935A discloses a traditional Chinese medicine composition for blocking the carcinogenesis of colitis, which can effectively relieve the inflammatory reaction of the intestinal mucosa, fundamentally reverse the "inflammation-cancer transformation" process of chronic enteritis, and can be widely used in the treatment of colitis-related colon cancer such as acute and chronic enteritis, ulcerative colitis, and Crohn's disease of the colon. There is no relevant report on its therapeutic effect on cough. Summary of the Invention

[0005] The first object of the present invention is to provide a new application of a known traditional Chinese medicine composition for blocking the carcinogenesis of colitis in the preparation of a drug for treating cough; the traditional Chinese medicine composition is composed of the following medicinal flavors in parts by weight: 9-30 parts of Pseudostellaria heterophylla, 3-9 parts of Atractylodes lancea, 3-10 parts of Ligusticum wallichii, 6-15 parts of Lonicera japonica, 9-15 parts of Dalbergia odorifera, and 3-10 parts of Myristica fragrans.

[0006] As a specific embodiment of the present invention, the traditional Chinese medicine composition is composed of the following medicinal flavors in parts by weight: 12 parts of Pseudostellaria heterophylla, 8 parts of Atractylodes lancea, 6 parts of Ligusticum wallichii, 15 parts of Lonicera japonica, 8 parts of Dalbergia odorifera, and 4 parts of Myristica fragrans.

[0007] In the above application, the cough is a dry cough or a cough with no phlegm symptoms.

[0008] The second object of the present invention is to provide a traditional Chinese medicine composition, comprising the following medicinal herbs in parts by weight: 11-13 parts of Pseudostellaria heterophylla, 7-9 parts of Atractylodes lancea, 5-7 parts of Ligusticum wallichii, 14-16 parts of Lonicera japonica, 7-9 parts of Dalbergia odorifera, 7-9 parts of Atractylodes macrocephala, 5-7 parts of Pinellia ternata.

[0009] Preferably, the traditional Chinese medicine composition comprises the following medicinal herbs in parts by weight: 11-13 parts of Pseudostellaria heterophylla, 7-9 parts of Atractylodes lancea, 5-7 parts of Ligusticum wallichii, 14-16 parts of Lonicera japonica, 7-9 parts of Dalbergia odorifera, 9-11 parts of Myristica fragrans, 7-9 parts of Atractylodes macrocephala, 9-11 parts of Prunus armeniaca var. ansu, 5-7 parts of Pinellia ternata.

[0010] As a specific embodiment of the present invention, the traditional Chinese medicine composition consists of the following medicinal herbs in parts by weight: 12 g of Pseudostellaria heterophylla, 8 g of Atractylodes lancea, 6 g of Ligusticum wallichii, 15 g of Lonicera japonica, 8 g of Dalbergia odorifera, 10 g of Myristica fragrans, 8 g of Atractylodes macrocephala, 10 g of Prunus armeniaca var. ansu, 6 g of Pinellia ternata.

[0011] The formula analysis of the above traditional Chinese medicine composition is as follows: Pseudostellaria heterophylla and Atractylodes macrocephala invigorate the spleen and replenish qi, strengthen the middle-jiao and consolidate the root, serving as the monarch herbs; Pinellia ternata dries dampness and reduces phlegm, Prunus armeniaca var. ansu relieves cough and asthma, and Myristica fragrans warms the middle-jiao and promotes diuresis, used for treating qi deficiency cough and asthma, and phlegm-heat accumulation caused by deficiency of the lung and spleen, serving as the minister herbs; Lonicera japonica and Scutellaria baicalensis clear heat and detoxify, and Atractylodes lancea, Dalbergia odorifera, and Ligusticum wallichii awaken the spleen, disperse stagnation, regulate qi and activate collaterals, serving as the assistant herbs; according to the theory of the exterior-interior relationship between the lung and the large intestine, Myristica fragrans and Prunus armeniaca var. ansu are used in large doses in the improved formula to achieve the effects of warming the middle-jiao and promoting diuresis, moistening the intestines and promoting defecation, and regulating qi movement. This formula eliminates the source of phlegm production by strengthening the spleen and removing dampness, eliminates the existing phlegm by reducing phlegm and relieving cough, and at the same time takes into account the effects of regulating qi, clearing heat, and dispelling cold, so that phlegm-dampness is resolved, qi movement is regulated, and lung qi is diffused, and the symptoms of cough with phlegm are naturally 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 herbs in parts by weight: 11-13 parts of Pseudostellaria heterophylla, 7-9 parts of Atractylodes lancea, 5-7 parts of Ligusticum wallichii, 14-16 parts of Lonicera japonica, 7-9 parts of Dalbergia odorifera, 7-9 parts of Atractylodes macrocephala, 5-7 parts of Pinellia ternata.

[0013] The medicinal herbs further include Myristica fragrans and Prunus armeniaca var. ansu. The traditional Chinese medicine extract is obtained by extracting the following medicinal herbs in parts by weight: 11-13 parts of Pseudostellaria heterophylla, 7-9 parts of Atractylodes lancea, 5-7 parts of Ligusticum wallichii, 14-16 parts of Lonicera japonica, 7-9 parts of Dalbergia odorifera, 9-11 parts of Myristica fragrans, 7-9 parts of Atractylodes macrocephala, 9-11 parts of Prunus armeniaca var. ansu, 5-7 parts of Pinellia ternata.

[0014] The extraction is carried out according to the following operations: Weigh each medicinal herb according to the ratio, add 10 times the amount of water, decoct twice, each time for 1 hour, and combine the filtrates to obtain the extract.

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

[0016] The dosage forms of the traditional Chinese medicine preparation include: decoction, pill, powder, granule, and capsule.

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

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

[0019] In the above application, the administration method of the traditional Chinese medicine composition, traditional Chinese medicine extract or traditional 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 beneficial effects achieved by the present invention are:

[0021] In the clinical trials of the present invention, it is found that the existing traditional Chinese medicine composition for blocking the carcinogenesis of colitis has a cough-relieving effect and has a significant therapeutic effect on dry cough and cough without phlegm.

[0022] Guided by the basic theory of traditional Chinese medicine, the present invention performs compatibility of traditional Chinese medicines according to the pathogenesis of cough and phlegm, improves the prescription, and combines Atractylodes macrocephala, almond, and Pinellia ternata on the basis of the prescription. The obtained composition not only has a cough-relieving effect, but also has a good therapeutic effect on the phlegm accompanied by cough caused by respiratory tract infection, chronic obstructive pulmonary disease, pharyngitis, and bronchitis. Description of the Drawings

[0023] Figure 1 are the symptom scores (mean ± SD) of patients in the single-drug group and the combination drug group (traditional Chinese medicine composition A + single drug).

[0024] Figure 2 are the pathological sections of rat lung tissues corresponding to different groups; among them, A: blank control group; B: model control group; C: positive drug group; D: traditional Chinese medicine composition A group; E: traditional Chinese medicine composition B group; F: traditional Chinese medicine composition C group.

[0025] Figure 3 are the LCQ scores (mean ± SD) of patients in the positive drug group and the traditional Chinese medicine composition B group. Detailed Embodiments

[0026] The present invention will be further described below in conjunction with specific embodiments, but the present invention is not limited to the following embodiments.

[0027] The experimental methods used in the following embodiments are all conventional methods unless otherwise specified.

[0028] The reagents, materials, instruments, etc. used in the following embodiments can be obtained from commercial channels unless otherwise specified.

[0029] Example 1

[0030] The Chinese medicine composition A granules have the following formula: 12 g of Pseudostellaria heterophylla, 8 g of Atractylodes lancea, 6 g of Ligusticum wallichii, 15 g of Lonicera japonica, 8 g of Dalbergia odorifera, 4 g of Myristica fragrans.

[0031] Example 2

[0032] The Chinese medicine composition B granules have the following formula: 12 g of Pseudostellaria heterophylla, 8 g of Atractylodes lancea, 6 g of Ligusticum wallichii, 15 g of Lonicera japonica, 8 g of Dalbergia odorifera, 10 g of Myristica fragrans, 8 g of Atractylodes macrocephala, 10 g of Prunus armeniaca var. ansu, 6 g of Pinellia ternata.

[0033] Example 3

[0034] The Chinese medicine composition C granules have the following formula: 12 g of Pseudostellaria heterophylla, 8 g of Atractylodes lancea, 6 g of Ligusticum wallichii, 15 g of Lonicera japonica, 8 g of Dalbergia odorifera, 8 g of Atractylodes macrocephala, 6 g of Pinellia ternata.

[0035] The Chinese medicine compositions described in Example 1, Example 2, and Example 3 can be prepared according to the following operations: Weigh the above-mentioned formula according to weight, add 10 times the amount of water, decoct twice, each time for 1 hour, combine the filtrates, dry at 60 °C and then pulverize for standby.

[0036] Experimental Example 1. Clinical observation of Chinese medicine composition A

[0037] Collect 56 patients with cough due to respiratory tract infection treated in the Second Affiliated Hospital of Shandong Medical University, and divide them into a single drug group (28 cases) and a combined medication group (28 cases).

[0038] Single drug group: Give Feilike mixture (Guizhou Jianxing Pharmaceutical Co., Ltd.), orally, 3 times a day, 20 ml each time.

[0039] Combined medication group: On the basis of Feilike mixture, additionally give the formula granules of Chinese medicine composition A, orally, 2 times a day, one dose of 53 g per day, and administer continuously for 7 days.

[0040] Before treatment and 7 days after treatment, according to the "Guiding Principles for Clinical Research of New Chinese Medicines (Trial)", symptoms such as cough, expectoration, sore throat, sputum expectoration, weakness, spontaneous sweating, chest tightness and shortness of breath are scored from 0 to 3 points in turn according to the severity of none, mild, moderate and severe, and the score is positively correlated with the symptom severity.

[0041] The results show that: As Figure 1As shown in the figure, before treatment, there was no significant difference in symptom scores between the single-drug group and the combined-drug group; however, 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 scores of the combined-drug group were significantly lower than those of the single-drug group, indicating that traditional Chinese medicine composition A and Feilike mixture have a synergistic therapeutic effect. At the same time, it was found that although the coughing, sore throat, chest tightness and other conditions of the patients improved significantly after taking traditional Chinese medicine composition A for one week, there were still cases of expectoration and sputum, so the formula of traditional Chinese medicine composition A was improved to enable it to treat sputum while treating cough.

[0042] Experimental Example 2. Experiment on the expectorant effect of traditional Chinese medicine composition

[0043] 1 Materials and methods

[0044] 1.1 Experimental animals

[0045] 36 SPF-grade male Wistar rats, 10 - 12 weeks old, with an initial body weight of 200 - 250 g, were purchased from Spf (Beijing) Biotechnology Co., Ltd. The selected animals were raised at a room temperature of 18 - 25 °C, a relative humidity of 50% - 60%, and a 12-hour day-night cycle.

[0046] 1.2 Reagents and drugs

[0047] (1) Modeling inducer: Flue-cured type Daqianmen brand cigarettes, with a tar content of 12 mg, a carbon monoxide content in the smoke of 14 mg, and a nicotine content in the smoke of 0.9 mg.

[0048] (2) Drugs:

[0049] Traditional Chinese medicine composition A: 12 g of Pseudostellaria heterophylla, 8 g of Atractylodes lancea, 6 g of Ligusticum wallichii, 15 g of Lonicera japonica, 8 g of Dalbergia odorifera, 4 g of Myristica fragrans.

[0050] Traditional Chinese medicine composition B: 12 g of Pseudostellaria heterophylla, 8 g of Atractylodes lancea, 6 g of Ligusticum wallichii, 15 g of Lonicera japonica, 8 g of Dalbergia odorifera, 10 g of Myristica fragrans, 8 g of Atractylodes macrocephala, 10 g of Prunus armeniaca var. ansu, 6 g of Pinellia ternata.

[0051] Traditional Chinese medicine composition C: 12 g of Pseudostellaria heterophylla, 8 g of Atractylodes lancea, 6 g of Ligusticum wallichii, 15 g of Lonicera japonica, 8 g of Dalbergia odorifera, 8 g of Atractylodes macrocephala, 6 g of Pinellia ternata. Compared with traditional Chinese medicine composition B, it reduced Myristica fragrans and Prunus armeniaca var. ansu.

[0052] The preparations of traditional Chinese medicine composition A, traditional Chinese medicine composition B, and traditional Chinese medicine composition C were carried out according to the following operations: Weigh the above prescriptions by weight, add 10 times the amount of water and decoct twice, each time for 1 hour, combine the filtrates, dry at 60 °C and then pulverize for standby.

[0053] Positive drug: Clinically commonly used carbocisteine, produced by Beijing Shuguang Pharmaceutical Co., Ltd.

[0054] 1.3 Main Instruments, Materials and Reagents

[0055] Phenobarbital Sodium for Injection, magnetic stirrer, OLYMPUS microscope, paraformaldehyde, adhesive slides and cover glasses, xylene, etc.

[0056] 1.4 Establishment of Animal Models and Group Drug Administration

[0057] The rats were adaptively fed for 7 days. According to their body weights, the rats were randomly divided into a normal control group (without any stimulation), a model control group (only modeled, without drug administration), a positive drug group (given carbocisteine), and three experimental groups (i.e., traditional Chinese medicine composition A group, traditional Chinese medicine composition B group, and traditional Chinese medicine composition C group), with a total of 6 groups, 6 rats in each group.

[0058] According to the reference (Study on the Mechanism of Jianpi Yifei Huatan Prescription in Treating Airway Mucus Hypersecretion in COPD Rats), a rat model with airway mucus hypersecretion was replicated by the simple cigarette smoking method. Except for the normal control group, the rats in other groups were placed in a self-made passive smoking glass fumigation box (60 cm * 50 cm * 40 cm). There were ventilation holes at the top and both sides of the box. The Daqianmen brand cigarettes were manually burned, and the smoke was introduced into the glass fumigation box through a three-way pipe. 12 Daqianmen cigarettes were burned for each fumigation. The smoke produced by each cigarette was approximately 1 L, the smoke concentration was approximately 5%, and it lasted for 0.5 hours. Smoking was carried out 2 times a day, once in the morning and once in the afternoon, for 16 consecutive weeks.

[0059] After 12 weeks of simple smoking, the three traditional Chinese medicine composition groups were given corresponding drugs by gavage every morning and afternoon for 2 weeks. The dosage was 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 the same as that of the treatment group.

[0060] 1.5 Experimental Methods and Results

[0061] (1) Pulmonary Function Examination

[0062] The rats were fasted but not water-deprived for 24 hours before sampling. On the day of sampling, the rats were anesthetized by intraperitoneal injection of 2% pentobarbital sodium (0.2 mL / 100 g). The neck was incised in the middle and flattened to expose the trachea. An experimental small animal pulmonary function measuring instrument was used to measure FVC (Forced Vital Capacity) and FEV (Forced Expiratory Volume): The pulmonary function of the rats was evaluated by FEV200 / FVC.

[0063] The results showed that: as shown in Table 1, the lung tissue structures of the positive drug group and the three traditional Chinese medicine composition groups were improved compared with the model control group. Among them, the effects of the positive drug group and Traditional Chinese Medicine Composition B were significantly better than those of the model control group, and the effect of Traditional Chinese Medicine Composition B was higher than that of the positive drug group.

[0064] Table 1 Comparison of lung functions of rats in each group

[0065]

[0066] Note: ** indicates P < 0.01 compared with the model control group, and * indicates P < 0.05 compared with the model control group.

[0067] (2)Pathological observation:

[0068] Lung tissues of rats in each group were taken, stained with HE, and observed under a microscope.

[0069] The results showed that: as Figure 2 shown, in the lung tissues of rats in the normal control group, the mucosa of each bronchus and alveoli was intact and the structure was normal; in the model control group, the mucosa of each bronchus and alveoli in the lung tissues was incomplete, inflammatory cell infiltration and congestion were visible in the bronchial wall, the bronchial smooth muscle was thickened, and the alveolar structure was disordered; while the lung tissue structures of the positive control group and the three traditional Chinese medicine composition groups were improved compared with the model control group, and the effect of Traditional Chinese Medicine Composition B was significantly better than that of other groups.

[0070] Experimental Example 3 Clinical observation on the phlegm-dissolving effect of Traditional Chinese Medicine Composition B

[0071] Thirty-six patients with cough and expectoration due to respiratory tract infection treated in the Second Affiliated Hospital of Shandong Medical University were collected and divided into a traditional Chinese medicine composition group (18 cases) and a positive drug group (18 cases). Among them, the positive drug group was given Feilike Mixture (Guizhou Jianxing Pharmaceutical Co., Ltd.), orally, 3 times a day, 20 ml each time; the traditional Chinese medicine composition group was given the formula granules of Traditional Chinese Medicine Composition B, orally, 2 times a day, 1 dose of 83 g per day, and administered continuously for 7 days.

[0072] (1)Lung function indexes: The forced expiratory volume in 1 second (FEV1) was measured, and the ratio of FEV1 to forced vital capacity (FVC) was calculated.

[0073] The results showed that: as shown in Table 2, there was no significant difference in FEV1 / FVC between the positive drug group and the traditional Chinese medicine composition group before treatment. After treatment, the FEV1 / FVC of the traditional Chinese medicine composition group was significantly higher than that of the positive drug group, indicating that the airway ventilation function of the group taking Traditional Chinese Medicine Composition B was significantly better than that of the positive drug group.

[0074] Table 2 Lung function indexes before and after treatment

[0075]

[0076] Note: ** indicates P < 0.01 compared with the positive drug group.

[0077] (2) Evaluation of patients' quality of life: Before treatment and 7 days after treatment, the symptoms and quality of life of patients 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 score is positively correlated with the quality of life.

[0078] The results showed that: as Figure 3 shown, before treatment, there was no significant difference in the LCQ scores between the positive drug group and the traditional Chinese medicine composition B group; 7 days after treatment, the LCQ scores of both the positive drug group and the traditional Chinese medicine composition B group were significantly improved, and compared with the positive drug group, the LCQ scores of the traditional Chinese medicine composition B group were significantly increased.

[0079] Although the present invention has been described in detail with general descriptions and specific embodiments above, on the basis of the present invention, some modifications or improvements can be made, which are obvious to those skilled in the art. Therefore, these modifications or improvements made without departing from the spirit of the present invention all fall within the scope of protection required by the present invention.

Claims

1. A traditional Chinese medicine composition for treating cough, characterized in that, It consists of the following medicinal flavors in parts by weight: 11 - 13 parts of Pseudostellaria heterophylla, 7 - 9 parts of Atractylodes lancea, 5 - 7 parts of Ligusticum chuanxiong, 14 - 16 parts of Lonicera japonica, 7 - 9 parts of Dalbergia odorifera, 9 - 11 parts of Myristica fragrans, 7 - 9 parts of Atractylodes macrocephala, 9 - 11 parts of Prunus armeniaca var. ansu, 5 - 7 parts of Pinellia ternata.

2. An extract of the traditional Chinese medicine composition according to claim 1, characterized in that, It is obtained by extracting the following medicinal flavors in parts by weight: 11 - 13 parts of Pseudostellaria heterophylla, 7 - 9 parts of Atractylodes lancea, 5 - 7 parts of Ligusticum chuanxiong, 14 - 16 parts of Lonicera japonica, 7 - 9 parts of Dalbergia odorifera, 9 - 11 parts of Myristica fragrans, 7 - 9 parts of Atractylodes macrocephala, 9 - 11 parts of Prunus armeniaca var. ansu, 5 - 7 parts of Pinellia ternata.

3. A traditional Chinese medicine preparation, characterized in that, It includes the traditional Chinese medicine composition described in claim 1 or the traditional Chinese medicine extract described in claim 2.

4. The traditional Chinese medicine preparation according to claim 3, wherein The dosage forms of the traditional Chinese medicine preparation include: decoction, pill, powder, granule, capsule.

5. Use of the traditional Chinese medicine composition described in claim 1, or the traditional Chinese medicine extract described in claim 2, or the traditional Chinese medicine preparation described in claim 3 or 4 in the preparation of a drug for treating cough.

6. The application according to claim 5, wherein The cough is caused by respiratory tract infection.

Images