Traditional Chinese medicine formula and application of traditional Chinese medicine formula in preparation of medicine for treating cough

Abstract

The invention provides a traditional Chinese medicine formula and application thereof in preparation of a medicine for treating cough, and belongs to the technical field of traditional Chinese medicines. According to the traditional Chinese medicine formula provided by the invention, 4-6 parts of white ginseng, 2-4 parts of American ginseng, 4-6 parts of schisandra chinensis, 2-4 parts of momordica grosvenori and 2-4 parts of rhizoma zingiberis are compatible with one another to jointly achieve the effects of tonifying qi and yin, warming lung to dissipate fluid retention, clearing heat and moistening lung and astringing lung to arrest cough, the cough caused by various disease causes is comprehensively treated, and the characteristics of treatment based on syndrome differentiation and holism of traditional Chinese medicine are reflected; the traditional Chinese medicine composition has a remarkable curative effect on traditional Chinese medicine clinical cough, can effectively relieve cough symptoms, change traditional Chinese medicine syndromes and improve lung functions, is good in safety, provides a new traditional Chinese medicine treatment scheme for cough treatment, and has a certain clinical application value.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine formula and application thereof in preparing a medicine for treating cough. Background Art

[0002] Cough is a common respiratory symptom and a defensive reflex activity of the body, which is conducive to clearing respiratory secretions and harmful factors. However, frequent and severe coughing can affect the patient's quality of life and may even indicate serious health problems. The causes of cough are complex and diverse, involving respiratory diseases, cardiovascular diseases, digestive diseases, environmental factors, drug side effects and other aspects. Globally, the incidence of cough is increasing year by year, which has brought a heavy burden to the patient's physical and mental health and social economy. In recent years, with the acceleration of industrialization, the intensification of environmental pollution, the accelerated pace of life and the aging of the population, the incidence of cough has increased significantly. Whether in developed or developing countries, cough is one of the common reasons for outpatient visits. According to statistics from the World Health Organization (WHO), hundreds of millions of people visit the doctor for cough-related diseases every year, and the trend is rising. In my country, the incidence of cough should not be underestimated, especially in winter and spring, when the number of cough patients increases significantly due to the changeable climate and high incidence of respiratory infections.

[0003] Traditional Chinese medicine has a long history and rich experience in treating cough. With its holistic concept and characteristics of syndrome differentiation and treatment, it plays a unique advantage in the treatment of cough. TCM believes that the occurrence of cough is closely related to the dysfunction of the lungs, spleen, kidneys and other internal organs. During treatment, it focuses on adjusting the balance of yin and yang and the function of internal organs. Through syndrome differentiation and treatment, a variety of methods such as Chinese medicine compound, acupuncture, massage and other methods are used for comprehensive treatment, which can not only relieve the symptoms of cough, but also fundamentally improve the patient's physique and enhance the body's immunity. However, there are many kinds of Chinese medicine cough preparations on the market, but some products have problems such as uneven quality and unstable efficacy, and lack of strict clinical trial verification. Therefore, it is of great clinical significance and social value to develop a safe, effective and quality-controlled Chinese medicine formula for the treatment of cough. Summary of the invention

[0004] The purpose of the present invention is to provide a Chinese medicine formula and its use in preparing a cough treatment drug, which can effectively alleviate cough symptoms, improve TCM syndromes, and enhance lung function with good safety.

[0005] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0006] The invention provides a Chinese medicine prescription, which comprises, by weight, 4-6 parts of white ginseng, 2-4 parts of American ginseng, 4-6 parts of schisandra chinensis, 2-4 parts of momordica grosvenori and 2-4 parts of dried ginger.

[0007] Preferably, the dosage form of the Chinese medicine prescription is selected from tablets, pills, capsules, granules, powders, oral liquids, syrups, pastes or aerosols.

[0008] Preferably, the Chinese medicine formula also includes pharmaceutically acceptable excipients.

[0009] Preferably, the auxiliary material is selected from fillers, binders, disintegrants, lubricants, flavoring agents, preservatives or thickeners.

[0010] Preferably, the filler is selected from lactose, mannitol, calcium sulfate, starch or pregelatinized starch;

[0011] The binder is selected from polyvinyl pyrrolidone, hydroxypropyl cellulose, methyl cellulose, hydroxyethyl cellulose or sodium carboxymethyl cellulose;

[0012] The disintegrant is selected from low-substituted hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, cross-linked polyvinylpyrrolidone, sodium carboxymethyl starch or an effervescent disintegrant;

[0013] The lubricant is selected from talc, silicon dioxide, magnesium stearate, micronized silica gel or hydrogenated vegetable oil;

[0014] The flavoring agent is selected from steviol glycoside, aspartame, sucrose, fructose or saccharin sodium;

[0015] The preservative is selected from sodium benzoate, potassium sorbate, methylparaben, ethylparaben or chlorobutanol;

[0016] The thickener is selected from sodium carboxymethyl cellulose, xanthan gum, sodium alginate, gelatin or gum arabic.

[0017] Preferably, the packaging form of the Chinese medicine prescription is selected from aluminum-plastic blister packaging, plastic bottle packaging, glass bottle packaging, composite film bag packaging or ampoule bottle packaging.

[0018] The present invention also provides application of the above Chinese medicine formula in preparing a medicine for treating cough.

[0019] Technical effects and advantages of the present invention:

[0020] The Chinese medicine formula provided by the invention mutually matches 4-6 parts of white ginseng, 2-4 parts of American ginseng, 4-6 parts of schisandra chinensis, 2-4 parts of momordica grosvenori and 2-4 parts of dried ginger, which can play the effects of invigorating qi and nourishing yin, warming the lungs and transforming phlegm, clearing away heat and moistening the lungs, and restraining the lungs and relieving cough. It comprehensively treats cough caused by various causes, embodies the characteristics of TCM syndrome differentiation and treatment and holistic concept, has significant therapeutic effect in treating TCM clinical cough, can effectively alleviate cough symptoms, improve veterinary TCM syndrome, improve lung function, and has good safety, provides a new TCM treatment scheme for the treatment of cough, and has certain clinical application value. DETAILED DESCRIPTION

[0021] The present invention provides a traditional Chinese medicine prescription, which comprises, by weight, 4-6 parts of white ginseng, 2-4 parts of American ginseng, 4-6 parts of schisandra chinensis, 2-4 parts of momordica grosvenori and 2-4 parts of dried ginger, and is further preferably 4.5-5.5 parts of white ginseng, 2.5-3.5 parts of American ginseng, 4.5-5.5 parts of schisandra chinensis, 2.5-3.5 parts of momordica grosvenori and 2.5-3.5 parts of dried ginger.

[0022] In the present invention, preferably, the dosage form of the Chinese medicine prescription is selected from tablets, pills, capsules, granules, powders, oral liquids, syrups, pastes or aerosols, and more preferably granules. Preferably, the Chinese medicine prescription also includes pharmaceutically acceptable excipients. Preferably, the excipients are selected from fillers, adhesives, disintegrants, lubricants, flavoring agents, preservatives or thickeners. Preferably, the filler is selected from lactose, mannitol, calcium sulfate, starch or pregelatinized starch; the binder is selected from polyvinyl pyrrolidone, hydroxypropyl cellulose, methyl cellulose, hydroxyethyl cellulose or sodium carboxymethyl cellulose; the disintegrant is selected from low-substituted hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, cross-linked polyvinylpyrrolidone, sodium carboxymethyl starch or effervescent disintegrant; the lubricant is selected from talc, silicon dioxide, magnesium stearate, micro-powdered silica gel or hydrogenated vegetable oil; the flavoring agent is selected from stevioside, aspartame, sucrose, fructose or sodium saccharin; the preservative is selected from sodium benzoate, potassium sorbate, methyl paraben, ethyl paraben or chlorobutanol; the thickener is selected from sodium carboxymethyl cellulose, xanthan gum, sodium alginate, gelatin or gum arabic. Preferably, the packaging form of the Chinese medicine formula is selected from aluminum-plastic blister packaging, plastic bottle packaging, glass bottle packaging, composite film bag packaging or ampoule bottle packaging.

[0023] The present invention also provides application of the above Chinese medicine formula in preparing a medicine for treating cough.

[0024] The technical solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0025] Example

[0026] Ingredients for the Chinese medicine formula granules: 5 grams of white ginseng, 3 grams of American ginseng, 5 grams of Schisandra chinensis, 3 grams of Momordica grosvenori, and 3 grams of dried ginger.

[0027] Experimental example

[0028] A total of 160 patients with cough who visited Shanghai Jinyiding Health Consulting Service Department were selected.

[0029] Inclusion criteria: meeting the TCM cough diagnostic criteria, cough duration of more than 2 weeks; age between 18-65 years old; patients voluntarily signed the informed consent form.

[0030] Exclusion criteria: patients with severe heart, liver, kidney and other organ dysfunction; patients with serious diseases such as malignant tumors; patients allergic to the study drugs; pregnant or lactating women.

[0031] 1. Research subjects

[0032] A total of 160 patients with cough were selected as research subjects.

[0033] 2. Study Drugs

[0034] The Chinese medicine formula granules are composed of 5 grams of white ginseng, 3 grams of American ginseng, 5 grams of Schisandra chinensis, 3 grams of Momordica grosvenori, and 3 grams of dried ginger. The medicinal materials are authenticated as genuine by professional Chinese medicine pharmacists. All the medicinal materials are mixed according to the established formula ratio to make a granule of uniform specifications, with a dosage of 19 grams per package.

[0035] (III) Grouping method

[0036] 160 patients were randomly divided into an experimental group and a control group, with 80 cases in each group. The random grouping was performed by a random number table, which was operated by a dedicated person to ensure the randomness and fairness of the grouping.

[0037] (IV) Treatment methods

[0038] Experimental group: Chinese medicine formula granules were given, 2 times a day, 1 packet each time, taken with boiled water.

[0039] Control group: given conventional cough suppressant treatment. According to the patient's specific condition and symptoms, appropriate cough suppressants were selected, such as dextromethorphan, ambroxol, etc., and taken according to the conventional dosage and usage in the drug instructions.

[0040] The treatment course for both groups of patients was 4 weeks. During the treatment period, patients were required to avoid eating spicy, greasy, and irritating foods and maintain a regular schedule and good living habits.

[0041] (V) Observation indicators

[0042] Cough symptom score: Before treatment and in the second and fourth weeks after treatment, the cough symptom score scale was used to evaluate the patient's cough frequency, cough severity, sputum, etc. The total score of the score scale is 10 points, and the higher the score, the more severe the cough symptom.

[0043] TCM Syndrome Score: Based on the syndrome characteristics of TCM cough, a TCM syndrome score table was developed to quantitatively score the patient's cough, sputum, wheezing, aversion to cold, fever, thirst and other symptoms. Scores were given before and after treatment, and the higher the score, the more severe the syndrome.

[0044] Pulmonary function indicators: Before treatment and 4 weeks after treatment, the patients' forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and FEV1 / FVC ratio were measured using a pulmonary function tester.

[0045] Adverse reactions: During the treatment, the adverse reactions of the two groups of patients were closely observed and recorded, such as gastrointestinal discomfort, allergic reactions, and symptoms of internal heat.

[0046] 6. Statistical methods

[0047] SPSS 22.0 statistical software was used for data analysis. The measurement data were expressed as mean ± standard deviation (x ± s), and the paired t test was used for comparison before and after treatment within the group, and the independent sample t test was used for comparison between groups; the enumeration data were expressed as cases (%), and the x 2 P < 0.05 was considered statistically significant.

[0048] Study Results

[0049] (I) Comparison of cough symptom scores between the two groups before and after treatment

[0050] Before treatment, there was no significant difference in cough symptom scores between the two groups (P>0.05), indicating that the two groups were comparable.

[0051] In the second week after treatment, the cough symptom score of the experimental group was significantly lower than that of the control group, and the difference was statistically significant (P<0.05).

[0052] At the 4th week after treatment, the cough symptom scores of the experimental group were further reduced, and the difference was statistically significant compared with the control group (P<0.01). The specific data are shown in Table 1 below:

[0053] Table 1 Comparison of cough symptom scores between the two groups of patients before and after treatment

[0054] Group n Score before treatment (x±s) Score after 2 weeks of treatment (x±s) Score after 4 weeks of treatment (x±s) Experimental Group 80 6.5±1.2 4.2±0.8 2.1±0.6 Control group 80 6.3±1.1 5.0±0.9 3.5±0.8

[0055] (II) Comparison of TCM syndrome scores between the two groups of patients before and after treatment

[0056] Before treatment, there was no significant difference in TCM syndrome scores between the two groups of patients (P>0.05).

[0057] At the 4th week after treatment, the TCM syndrome scores of the experimental group were significantly lower than those of the control group, and the difference was statistically significant (P<0.05). The specific data are shown in Table 2 below:

[0058] Table 2 Comparison of TCM syndrome scores between the two groups of patients before and after treatment

[0059] Group n Score before treatment (x±s) Treatment score for 4 weeks (x±s) Experimental Group 80 12.5±2.5 6.2±1.8 Control group 80 12.3±2.3 8.5±2.0

[0060] (III) Comparison of lung function indicators between the two groups of patients before and after treatment

[0061] Before treatment, there were no significant differences in FEV1, FVC and FEV1 / FVC ratio between the two groups of patients (P>0.05).

[0062] At 4 weeks after treatment, the FEV1, FVC and FEV1 / FVC ratio of the experimental group were significantly higher than those of the control group, and the difference was statistically significant (P<0.05). The specific data are shown in Table 3 below:

[0063] Table 3 Comparison of lung function indicators between the two groups of patients before and after treatment

[0064] Group n FEV1(L) FVC(L) FEV1 / FVC (%) Experimental Group 80 2.45±0.42 3.10±0.50 76.5±5.5 Control group 80 2.20±0.38 2.80±0.45 72.0±5.0

[0065] (IV) Comparison of adverse reactions between the two groups of patients

[0066] During the treatment, 5 patients in the experimental group experienced adverse reactions, including 3 cases of gastrointestinal discomfort (manifested as mild nausea and loss of appetite) and 2 cases of internal heat symptoms (dry mouth, sore throat). After adjusting their diet and taking proper rest, the symptoms were relieved.

[0067] In the control group, 8 patients experienced adverse reactions, including 5 cases of gastrointestinal discomfort (nausea, vomiting, diarrhea), 2 cases of drowsiness, and 1 case of dizziness. After corresponding treatment, the symptoms were improved.

[0068] There was no statistically significant difference in the incidence of adverse reactions between the two groups of patients (P>0.05).

[0069] Typical cases:

[0070] (I) Case 1 (experimental group)

[0071] Patient Wang XX, female, 45 years old, had a cough for 3 months. The patient reported frequent coughing, about 10-15 times during the day, aggravated coughing at night, affecting sleep, coughing a small amount of white sticky sputum, not easy to cough up, accompanied by shortness of breath, fatigue, dry mouth, chills and other symptoms. The tongue was pale red, the fur was thin and white, and the pulse was thin and weak. TCM diagnosed it as cough (Qi and Yin deficiency with lung cold). Chinese medicine formula granules were given for treatment. After 1 week of treatment, the patient's cough frequency decreased, and sputum was easier to cough up than before. After 2 weeks of treatment, the number of coughs decreased significantly, about 5-8 times during the day, 1-2 times at night, shortness of breath, fatigue symptoms improved, dry mouth, chills symptoms alleviated. After 4 weeks of treatment, the cough symptoms basically disappeared, only occasionally coughing in cold air, no sputum, physical strength recovered, and the quality of life was significantly improved.

[0072] (II) Case 2 (control group)

[0073] Patient Li XX, male, 38 years old, had a cough for 2 months after catching a cold. The cough was paroxysmal, accompanied by a large amount of white foamy sputum. When the cough was severe, it was accompanied by chest pain. The cough worsened after activity, accompanied by mild dyspnea. The tongue was pale, the tongue coating was white and greasy, and the pulse was slippery. The Chinese medicine diagnosis was cough (phlegm and dampness in the lungs). Conventional cough suppressants were given. After 2 weeks of treatment, the cough symptoms were slightly relieved, but the amount of sputum was still large. After 4 weeks of treatment, the number of coughs decreased, but there were still obvious symptoms of sputum and dyspnea after activity.

[0074] discuss:

[0075] (I) Drug compatibility analysis

[0076] White ginseng greatly replenishes vital energy, nourishes the spleen and benefits the lungs. It can enhance the body's resistance, improve lung function, and replenish vital energy for patients with weak lung qi.

[0077] American ginseng can replenish qi and nourish yin, clear away heat and promote body fluid. When used together with white ginseng, it can not only replenish qi, but also nourish yin and clear away heat. It is especially suitable for patients with cough due to deficiency of both qi and yin, and can relieve symptoms such as shortness of breath, fatigue, and dry mouth during cough.

[0078] Schisandra chinensis has the effects of astringing and solidifying, replenishing Qi and promoting the production of body fluids, nourishing the kidneys and calming the mind. Its effect of astringing the lungs and relieving coughs can reduce the dissipation of lung Qi, and it has a good therapeutic effect on long-term coughs and weak asthma.

[0079] Luo Han Guo can clear away heat and moisten the lungs, relieve sore throat and open voice, lubricate the intestines and promote bowel movements. It can improve throat discomfort associated with cough, clear away heat and resolve phlegm, and has an auxiliary therapeutic effect on lung heat cough or phlegm heat cough.

[0080] Dried ginger warms the middle and dispels cold, restores yang and unclogs the meridians, warms the lungs and transforms phlegm. It can warm and dispel lung cold, transform phlegm and relieve cough for cough caused by cold evil invading the lungs or lung cold.

[0081] These five herbs work together to replenish qi and nourish yin, warm the lungs and transform phlegm, clear away heat and moisten the lungs, and astringe the lungs to relieve cough. They provide comprehensive treatment for coughs caused by various causes, reflecting the characteristics of Chinese medicine's differentiation of symptoms and treatment and holistic concept.

[0082] (II) Analysis of treatment effects

[0083] The results of this study showed that the experimental group was significantly better than the control group in terms of cough symptom scores, TCM syndrome scores, and lung function indicators. This indicates that TCM formula granules can more effectively alleviate cough symptoms, improve patients' TCM syndromes, and improve lung function.

[0084] From the perspective of cough symptom scores, the scores of the experimental group in the 2nd and 4th weeks after treatment were significantly lower than those of the control group, indicating that the Chinese herbal formula granules can relieve cough symptoms more quickly, and the effect is more significant as the treatment time increases.

[0085] In terms of TCM syndrome scores, the scores of the experimental group were significantly reduced after treatment, indicating that the Chinese medicine formula granules can comprehensively improve the patients' TCM syndromes and adjust the patients' physical condition as a whole.

[0086] The improvement in lung function indicators shows that Chinese herbal formula granules can promote the ventilation function of the lungs, improve the gas exchange efficiency of the lungs, and facilitate the recovery of lung diseases.

[0087] (III) Safety analysis

[0088] Both groups of patients experienced certain adverse reactions during the treatment, but the difference in the incidence of adverse reactions was not statistically significant. The adverse reactions in the experimental group were mainly gastrointestinal discomfort and internal heat symptoms, which may be related to the warm nature of the drug and individual differences; the adverse reactions in the control group were mainly gastrointestinal discomfort, drowsiness, dizziness, etc., which are related to the side effects of conventional cough suppressants. After corresponding treatment, the adverse reaction symptoms of both groups of patients were relieved, indicating that the Chinese medicine formula granules have good safety.

[0089] As can be seen from the above embodiments, the present invention provides a Chinese medicine formula granule composed of white ginseng, American ginseng, schisandra chinensis, momordica grosvenori and dried ginger, which has a significant therapeutic effect in treating clinical cough in traditional Chinese medicine, can effectively alleviate cough symptoms, improve traditional Chinese medicine syndromes, improve lung function, and has good safety. The present invention provides a new Chinese medicine treatment scheme for the treatment of cough, which has certain clinical application value.

[0090] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine prescription, characterized in that: Calculated by weight, the invention comprises 4-6 parts of white ginseng, 2-4 parts of American ginseng, 4-6 parts of schisandra chinensis, 2-4 parts of momordica grosvenori and 2-4 parts of dried ginger.

2. The Chinese medicine prescription according to claim 1, characterized in that: The dosage form of the Chinese medicine prescription is selected from tablets, pills, capsules, granules, powders, oral liquids, syrups, ointments or aerosols.

3. The Chinese medicine prescription according to claim 1, characterized in that: The Chinese medicine formula also includes pharmaceutically acceptable excipients.

4. The Chinese medicine prescription according to claim 1, characterized in that: The auxiliary material is selected from fillers, binders, disintegrants, lubricants, flavoring agents, preservatives or thickeners.

5. The Chinese medicine prescription according to claim 4, characterized in that: The filler is selected from lactose, mannitol, calcium sulfate, starch or pregelatinized starch; The binder is selected from polyvinyl pyrrolidone, hydroxypropyl cellulose, methyl cellulose, hydroxyethyl cellulose or sodium carboxymethyl cellulose; The disintegrant is selected from low-substituted hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, cross-linked polyvinylpyrrolidone, sodium carboxymethyl starch or an effervescent disintegrant; The lubricant is selected from talc, silicon dioxide, magnesium stearate, micronized silica gel or hydrogenated vegetable oil; The flavoring agent is selected from steviol glycoside, aspartame, sucrose, fructose or saccharin sodium; The preservative is selected from sodium benzoate, potassium sorbate, methylparaben, ethylparaben or chlorobutanol; The thickener is selected from sodium carboxymethyl cellulose, xanthan gum, sodium alginate, gelatin or gum arabic.

6. The Chinese medicine prescription according to claim 1, characterized in that: The packaging form of the Chinese medicine prescription is selected from aluminum-plastic blister packaging, plastic bottle packaging, glass bottle packaging, composite film bag packaging or ampoule bottle packaging.

7. Use of the Chinese medicine formula according to any one of claims 1 to 6 in the preparation of a drug for treating cough.