A Chinese medicine composition for treating cold cough and its preparation method and application

Abstract

The present invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a medicinal diet composition for treating cold cough, and a preparation method and application thereof. The medicinal diet composition of the present invention comprises, by mass, 50-100 parts of kumquat, 10-20 parts of ginger, 2-3 parts of tangerine peel, and 5-10 parts of platycodon. The medicinal diet composition of the present invention can quickly improve the symptoms of cold cough caused by novel coronavirus infection, and is particularly suitable for patients with cold cough caused by novel coronavirus infection in areas where drug resources are relatively scarce, medical resources are relatively weak, and it is relatively difficult to purchase medicine.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating cold cough, and a preparation method and application thereof. Background Art

[0002] Cough is a common symptom after infection with the new coronavirus. Traditional Chinese medicine has unique advantages in treating cough after infection with the new coronavirus. At present, there are many traditional Chinese medicines for treating cough after infection with the new coronavirus. However, compared with cities, rural areas are relatively short of epidemic prevention drugs, relatively weak medical resources, and relatively difficult to purchase drugs. Therefore, patients infected with the new coronavirus in rural areas often fail to receive timely and effective treatment, which leads to further development of the disease. Traditional Chinese medicine believes that "medicine and food have the same origin", and puts diet on par with medicine. In addition to taking medicine, doctors of all dynasties pay more attention to the conditioning effect of diet when treating diseases. Traditional Chinese medicine diet therapy has a deep cultural and historical origin. Therefore, in areas where drug resources are relatively scarce, medical resources are relatively weak, and it is relatively difficult to purchase drugs, local medicinal materials and food ingredients can be used to relieve symptoms such as cough after infection with the new coronavirus through diet therapy. At present, there is still a lack of a traditional Chinese medicine composition that is easy to obtain and has good efficacy. Summary of the invention

[0003] The first purpose of the present invention is to provide a traditional Chinese medicine composition for treating cold cough. The second purpose of the present invention is to provide a method for preparing the traditional Chinese medicine composition. The third purpose of the present invention is to provide an application of the traditional Chinese medicine composition.

[0004] According to a first aspect of the present invention, a traditional Chinese medicine composition for treating cold cough is provided, wherein the raw materials thereof comprise, by weight, 50-100 parts of kumquat, 10-20 parts of ginger, 2-3 parts of tangerine peel, and 5-10 parts of platycodon.

[0005] The present invention is directed to the cold cough caused by novel coronavirus infection, which is mainly manifested by cough, itchy throat, coughing up white sputum, fear of cold, headache, clear runny nose, cold pain in limbs, white or greasy tongue, floating and tight pulse, etc.

[0006] In the formula, kumquat is warm in nature, pungent and sweet in taste, and can regulate qi and relieve depression, digest food and resolve phlegm, so it is the main drug. Tangerine peel is bitter, pungent and warm, and can regulate qi and strengthen the spleen, dry dampness and resolve phlegm. When qi is smooth, phlegm will disappear, which enhances the function of regulating qi and resolving phlegm of the main drug, so it is the assistant drug. Platycodon grandiflorum can open up the lung qi to help evacuate external evil, so it is the adjuvant drug. Ginger is pungent and warm in nature, enters the lung to dispel cold and stop vomiting, relieve depression and eliminate phlegm, so it is the guiding drug. All the drugs work together to play the effect of dispelling cold and relieving exterior symptoms, resolving phlegm and relieving cough, and can effectively alleviate the symptoms of cold cough caused by new coronavirus infection.

[0007] The sources of raw materials for this recipe are as follows:

[0008] Kumquat: the fruit of Fortunella margarita (Lour.) Swingle of the Rutaceae family.

[0009] Ginger: The fresh rhizome of Zingiber officinale Rosc., a plant of the ginger family.

[0010] Tangerine peel: the dried mature peel of the Rutaceae plant Citrus reticulata Blanco and its cultivated varieties.

[0011] Platycodon: The dried root of Platycodon grandiflorum (Jacq.) A.DC., a plant of the Campanulaceae family.

[0012] In some embodiments, the Chinese medicine composition for treating cold cough comprises, by weight, 100 parts of kumquat, 20 parts of ginger, 3 parts of tangerine peel, and 10 parts of platycodon.

[0013] In some embodiments, the Chinese medicine composition for treating cold cough comprises, by weight, 50 parts of kumquat, 10 parts of ginger, 2 parts of tangerine peel, and 5 parts of platycodon.

[0014] In some embodiments, a pharmaceutically acceptable excipient is also included.

[0015] According to a second aspect of the present invention, there is provided a method for preparing the above-mentioned Chinese medicine composition for treating cold cough, comprising the following steps:

[0016] Slice the ginger but do not cut the kumquat, then mix the sliced ​​ginger with the kumquat, tangerine peel and platycodon, add 3-5 times the weight of water and boil for 30-60 minutes to obtain the product.

[0017] The kumquat is not cut when preparing the traditional Chinese medicine composition, so that the effective ingredients in the kumquat peel and pulp can be boiled more effectively, and the traditional Chinese medicine tastes sweet and sour, and at the same time, it can not only focus on relieving cough and reducing phlegm, but also can better cooperate with other ingredients to exert the effects of dispelling cold, relieving exterior symptoms, reducing phlegm and relieving cough.

[0018] According to the third aspect of the present invention, there is provided the use of the above-mentioned traditional Chinese medicine composition for treating cold cough in the preparation of a medicine for treating novel coronavirus infection.

[0019] According to a fourth aspect of the present invention, there is provided the use of the above-mentioned traditional Chinese medicine composition for treating cold cough in the preparation of a medicine for treating cough caused by novel coronavirus infection, accompanied by itchy throat, coughing up white sputum or fear of cold.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] (1) The Chinese medicine composition of the present invention can quickly improve the symptoms of cold cough caused by novel coronavirus infection, and is particularly suitable for patients with cold cough caused by novel coronavirus infection in areas where drug resources are relatively scarce, medical resources are relatively weak, and drug purchase is relatively difficult.

[0022] (2) The present invention selects four substances that are both food and Chinese medicinal materials to form a Chinese medicine composition, selects kumquat, a common food ingredient on the market, as the main medicine, and combines it with ginger, tangerine peel, and platycodon, which are common Chinese medicinal materials with medicinal and edible properties on the market. The material is convenient to obtain, easy to operate, delicious, and inexpensive. It provides a feasible medication option for patients with cold cough after novel coronavirus infection, and to a great extent improves the problem of shortage of drug resources and difficulty in purchasing drugs in rural areas. DETAILED DESCRIPTION

[0023] The present invention is further described in detail below in conjunction with specific embodiments. It is worth noting that the following embodiments are only for better explanation of the present invention and are not intended to limit the scope of protection of the present invention. The undisclosed process steps in the embodiments are prior art. Unless otherwise specified, the following raw materials are commercially available.

[0024] Example 1

[0025] The Chinese medicine for treating cold cough of the present embodiment comprises, by weight, 100 g of kumquat, 20 g of ginger, 3 g of tangerine peel, and 10 g of platycodon.

[0026] The preparation method comprises the following steps:

[0027] Slice the ginger but do not cut the kumquat. Then mix the sliced ​​ginger with the kumquat, tangerine peel and platycodon, add to 500mL of water, and boil for 40min until the volume reaches 200mL.

[0028] The traditional Chinese medicine prepared in this embodiment is suitable for adult patients with cold cough caused by novel coronavirus infection. The dosage of one dose is 200 mL, one dose is taken a day, and one dose is taken in 3-4 times.

[0029] Example 2

[0030] The Chinese medicine for treating cold cough of the present embodiment comprises the following raw materials in parts by mass: 50 g kumquat, 10 g ginger, 2 g tangerine peel and 5 g platycodon.

[0031] The preparation method comprises the following steps:

[0032] Slice the ginger but do not cut the kumquat. Then mix the sliced ​​ginger with the kumquat, tangerine peel and platycodon, add to 300mL of water, and boil for 40min until the volume reaches 150mL.

[0033] The traditional Chinese medicine prepared in this embodiment is suitable for children with cold cough caused by novel coronavirus infection. The dosage of one dose is 150 mL, and one dose is taken a day, which can be divided into 3-4 doses.

[0034] Below, in order to illustrate the therapeutic effect of the Chinese medicine composition of the present invention on cold cough caused by novel coronavirus infection, clinical trials were carried out using the Chinese medicine prepared in Examples 1-2.

[0035] 1. Relevant standards

[0036] 1. Diagnostic criteria

[0037] 1. Western medicine disease diagnosis

[0038] Refer to the "Diagnosis and Treatment Plan for New Coronavirus Infection (Trial Ninth Edition)", there is epidemiological history and clinical manifestations, and it meets the etiological evidence (positive nucleic acid test for new coronavirus pneumonia or positive antigen test).

[0039] The disease is classified into mild and common types according to the Diagnosis and Treatment Plan for New Coronavirus Infection (Trial Ninth Edition).

[0040] 2. TCM syndrome diagnostic criteria

[0041] Hot cough: cough, sore throat, bitter taste in the mouth with yellow sputum, fever or irritability, red tongue or red tongue, yellow tongue coating, and floating and rapid pulse.

[0042] Cold cough: cough with itchy throat, coughing up white phlegm, fear of cold, white or greasy tongue, floating and tight pulse, accompanied by headache, clear runny nose, and cold and painful limbs.

[0043] (II) Inclusion criteria

[0044] 1. Those who are positive for novel coronavirus nucleic acid test or antigen test;

[0045] 2. According to the diagnostic criteria of the "Diagnosis and Treatment Plan for Novel Coronavirus Infection (Trial Version 9)", the clinical classification is mild or common;

[0046] 3. Cough as the main symptom;

[0047] 4. The patient or his / her legal representative signs the informed consent form.

[0048] (III) Exclusion criteria

[0049] 1. People with allergic constitution or those who are allergic to the taste of the Chinese medicine composition of the present invention;

[0050] 2. Patients with chronic lung diseases such as bronchiectasis, bronchopneumonia, chronic lung abscess, chronic cough for more than 8 weeks, chronic pharyngitis with cough, lung cancer, respiratory bacterial infection, etc., which may affect the judgment of cough symptoms;

[0051] 3. Heavy smokers (years of smoking × number of cigarettes smoked per day ≥ 400, such as smoking history ≥ 20 years, ≥ 20 cigarettes per day);

[0052] 4. Those who cannot cooperate to complete the follow-up;

[0053] 5. Pregnant female subjects;

[0054] 6. Patients with severe underlying diseases or acute exacerbation of chronic diseases, such as acute heart failure;

[0055] 7. Participants who have participated in or are currently participating in other clinical trials within one month before this study.

[0056] 2. Case Sources and Grouping

[0057] The cases came from patients infected with the new coronavirus in Yangshuo Town, Baisha Town, Fuli Town, Gaotian Town, and Puyi Township, Yangshuo County, Guangxi.

[0058] The experiment was based on a real-world observational study design, with an experimental group: control group = 2:1 design; the bilateral α = 0.05, β = 0.10, that is, at a test level of 0.05, at a confidence level of 90%, 483 cases were required in the experimental group and 242 cases in the control group; considering a 15% loss to follow-up rate, 555 cases were required in the experimental group and 278 cases were required in the control group, for a total of 833 samples.

[0059] 3. Observation indicators and time points

[0060] (1) General information, including age, gender, height, weight, past medical history, onset time, whether or not COVID-19 vaccination was received, smoking history, etc., was collected during the first observation.

[0061] (2) Clinical symptoms and signs: including fever, cough, shortness of breath, sore throat, diarrhea, nasal congestion and runny nose, fatigue, poor appetite, headache, muscle pain, chest tightness, chest pain, loss of taste, loss of smell, etc.; collected daily during treatment.

[0062] (3) Cough severity score sheet, as shown in Table 1, was collected every day during the treatment period. The treatment period was 5 days, and patients whose cough symptoms disappeared in the first 5 days ended the follow-up on the 6th and 7th days.

[0063] Table 1 Cough severity score table

[0064]

[0065] (4) Treatment plan, including whether to use other drugs for the treatment of novel coronavirus infection or symptomatic treatment.

[0066] (5) Condition after taking the medicine, collected every day during the treatment period.

[0067] IV. Treatment Plan

[0068] 1. Conventional treatment plan: Refer to the "Diagnosis and Treatment Plan for New Coronavirus Pneumonia (Trial Ninth Edition)" for diagnosis and treatment, including symptomatic antipyretic, analgesic, and anti-vomiting.

[0069] 2. TCM syndrome differentiation and treatment plan:

[0070] (1) Cold cough: Adult patients take the Chinese medicine prepared in Example 1, with a dosage of 200 ml, one dose per day, and one dose divided into 3-4 doses; children take the Chinese medicine prepared in Example 2, with a dosage of 150 ml, one dose per day, and one dose divided into 3-4 doses. The treatment period is 5 days.

[0071] (2) Heat cough: Adults: 100g kumquat, 50g water chestnut, 10g northern adenophora, 10g platycodon, add 500ml water, boil for 40 minutes to 200ml, one dose is 200ml, one dose a day, one dose is taken in 3-4 times; Children: 50g kumquat, 30g water chestnut, 5g northern adenophora, 5g platycodon, add 300ml water, boil for 40 minutes to 150ml, one dose is 150ml, one dose a day, one dose is taken in 3-4 times. Treatment period is 5 days.

[0072] In principle, patients who adopt a TCM syndrome differentiation treatment plan should not take other Chinese medicines for cough and phlegm.

[0073] The control group received conventional treatment, and the experimental group received TCM syndrome differentiation treatment. The patients were divided into the control group or the experimental group according to the treatment they actually received, and the efficacy indicators between the groups were compared. The time for the cough symptom to disappear was the main efficacy indicator.

[0074] 5. Statistical Methods

[0075] All data were analyzed using SPSS and R. Normally distributed data were expressed as "mean ± standard deviation", and t-test or analysis of variance were used for inter-group comparisons; non-normally distributed data were tested using nonparametric tests; categorical variables were expressed as number of cases and percentages, and χ2 test or exact probability method was used for inter-group comparisons; propensity score matching and Cox regression analysis were used to compare the time until cough symptoms disappeared between the two groups. Propensity score matching used nearest neighbor matching, and the caliper value was set to 0.2. P < 0.05 indicated statistically significant differences.

[0076] VI. Test Results

[0077] A total of 1434 cases were followed up. After excluding patients without cough at baseline (627 cases), patients with chronic lung disease (13 cases) and heavy smokers (30 cases), a total of 763 cases were included, including 282 cases in the control group and 481 cases in the experimental group. In the experimental group, there were 204 patients with hot cough, 225 patients with cold cough, and 52 patients did not record cold cough and hot cough, and these 52 cases were not included in the analysis.

[0078] In order to illustrate the therapeutic effect of the Chinese medicine composition of the present invention on cold cough caused by novel coronavirus infection, the patients with cold cough were divided into a Chinese medicine composition group, and then the control group and the Chinese medicine composition group were analyzed as follows:

[0079] 1. Baseline analysis

[0080] The baseline data of the patients are shown in Table 2:

[0081] Table 2 Baseline comparison between the control group and the Chinese medicine composition group

[0082]

[0083]

[0084] Note: Follow-up time = last follow-up date - baseline form completion date.

[0085] As can be seen from Table 2, the median follow-up time of the Chinese medicine combination group was 6 days, and the median follow-up time of the control group was 7 days. The patients in the Chinese medicine combination group had a longer cough duration at the time of enrollment, and there were more smoking patients. The difference between the two groups was statistically significant (P < 0.05).

[0086] 2. Comparison of the two groups before and after propensity score matching

[0087] Propensity score matching was performed based on age, gender, whether there were underlying diseases, time from the first cough to enrollment, number of vaccinations, smoking, whether cough suppressants were taken before enrollment, and cough symptom score before enrollment. After matching, the two groups had 180 cases each. The two groups were balanced and comparable except for whether cough suppressants were taken before enrollment. The comparison results of the two groups after propensity score matching are shown in Table 3:

[0088] Table 3 Comparison of the two groups after propensity score matching

[0089]

[0090]

[0091] Note: SMD, standardized mean difference, SMD < 0.1 indicates that the two groups are balanced and comparable.

[0092] 3. Comparison of the results after matching

[0093] The regression analysis after propensity score matching between the two groups is shown in Table 4:

[0094] Table 4 Regression analysis after propensity score matching between the two groups

[0095]

[0096] Notes: (1) HR: Hazard ratio. HR>1 indicates that the Chinese medicine combination group is more likely to experience disappearance of cough symptoms than the control group.

[0097] (2) Definition of cough disappearance: For patients with a total score of >5 on the cough severity scoring scale shown in Table 1, the date from the first dose to the first time a score of 5 on the cough severity scoring scale shown in Table 1 appears after the dose;

[0098] (3) The median follow-up time for the Chinese medicine combination group was 6 days, and the median follow-up time for the control group was 7 days.

[0099] As can be seen from Table 4, after a median follow-up of 6 days for the Chinese medicine combination group and 7 days for the control group, the disappearance of cough symptoms in the Chinese medicine combination group was 1.28 times that of the control group, 95% CI: (1.01, 1.62).

[0100] 4. Comparison of secondary indicators between the two groups after propensity score matching

[0101] The comparison results of the secondary indicators of the two groups after propensity score matching are shown in Table 5:

[0102] Table 5 Comparison of secondary indicators between the two groups after propensity score matching

[0103]

[0104]

[0105] Notes: (1) CET: Cough Evaluation Test score, obtained by scoring according to Table 1;

[0106] (2) There were cases of loss to follow-up on the 3rd and 5th days, so the number of follow-up on the 3rd and 5th days was less than 180. The cough symptom disappearance rate on the 3rd day was a=87 / 159=54.7%; b=61 / 158=38.6%; the cough symptom disappearance rate on the 5th day was c=85 / 161=52.8%; d=89 / 147=60.5%;

[0107] (3) The treatment period was 5 days. During the treatment period, the patients filled in the CET score sheet every day. The patients whose cough symptoms disappeared in the first 5 days ended the follow-up on the 6th and 7th days. Therefore, the number of patients followed up on the 7th day was less than 180. The cough symptom disappearance rate on the 7th day was e = 39 / 88 = 44.3%; f = 88 / 105 = 83.8%.

[0108] As can be seen from Table 5, on the 3rd day after medication, the cough symptom disappearance rate in the control group was higher, and the difference was statistically significant; on the 5th day after medication, there was no statistically significant difference in the cough symptom disappearance rate between the two groups; on the 7th day after medication, the cough symptom disappearance rate in the Chinese medicine combination group was higher than that in the control group (83.8% in the Chinese medicine combination group vs 44.3% in the control group, P<0.001), and the difference between the two groups was statistically significant.

[0109] 5. Conclusion

[0110] After taking the Chinese medicine composition of the present invention, the disappearance rate of cough symptoms in patients with cold cough infected with the new coronavirus was 1.28 (95% CI: 1.01, 1.62) times that of the control group (the median follow-up of the Chinese medicine composition group was 6 days, and the median follow-up of the control group was 7 days). Seven days after taking the Chinese medicine composition of the present invention, the disappearance rate of cough symptoms in patients with cold cough infected with the new coronavirus was higher than that in the control group, and the difference was statistically significant. This shows that the Chinese medicine composition of the present invention can significantly improve the symptoms of cold cough infected with the new coronavirus.

[0111] The above are only some specific embodiments of the present invention. For those skilled in the art, several modifications and improvements can be made without departing from the creative concept of the present invention, which all belong to the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating cold cough, characterized in that: The raw material composition is as follows: 50-100 parts of kumquat, 10-20 parts of ginger, 2-3 parts of tangerine peel and 5-10 parts of platycodon grandiflorum in parts by mass.

2. The Chinese medicine composition for treating cold cough according to claim 1, characterized in that: The raw material composition is as follows by mass: 100 parts of kumquat, 20 parts of ginger, 3 parts of tangerine peel and 10 parts of platycodon.

3. The Chinese medicine composition for treating cold cough according to claim 1, characterized in that: The raw material composition is as follows by mass: 50 parts of kumquat, 10 parts of ginger, 2 parts of tangerine peel and 5 parts of platycodon.

4. The Chinese medicine composition for treating cold cough according to any one of claims 1 to 3, characterized in that: Pharmaceutically acceptable excipients may also be added.

5. The method for preparing the Chinese medicine composition for treating cold cough according to any one of claims 1 to 4, characterized in that: The following steps are involved: Slice the ginger but do not cut the kumquat, then mix the sliced ​​ginger with the kumquat, tangerine peel and platycodon, add 3-5 times the weight of water and boil for 30-60 minutes to obtain the product.

6. Use of the traditional Chinese medicine composition for treating cold cough according to any one of claims 1 to 4 in the preparation of a medicine for treating cough caused by novel coronavirus infection, accompanied by itchy throat, coughing up white sputum or fear of cold.

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