CN112294911A

CN112294911A - Traditional Chinese medicine composition for treating cough with lung heat

Info

Publication number: CN112294911A
Application number: CN202011407579.5A
Authority: CN
Inventors: 刘春明
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-12-04
Filing date: 2020-12-04
Publication date: 2021-02-02

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating cough with lung heat and a preparation method thereof. The traditional Chinese medicine composition for treating lung-heat cough is prepared from raw materials of ephedra, almond, gypsum, liquorice, honeysuckle, houttuynia cordata, fructus forsythiae, scutellaria baicalensis, cortex mori, thunberg fritillary bulb, radix peucedani, aster, platycodon grandiflorum and fructus aurantii. The traditional Chinese medicine composition has definite curative effect on lung heat cough, has obvious curative effect on cough accompanied by symptoms of expectoration, fever, sore throat, suffocating asthma, nasal obstruction and running nose, headache and body pain or constipation, has obvious effect on acute bronchitis or pneumonia in western medicine, has good safety and has popularization value.

Description

Traditional Chinese medicine composition for treating cough with lung heat

Technical Field

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating cough with lung heat.

Background

Cough (cough) is a common symptom of the respiratory tract, caused by inflammation, foreign body, physical or chemical irritation of the trachea, bronchial mucosa or pleura.

Coughing is manifested by a closing of the glottis, contraction of the respiratory muscles, an increase in the pressure in the lungs, followed by an opening of the glottis and ejection of air from the lungs, usually with a sound. Cough has a protective effect of removing respiratory tract foreign bodies and secretions. However, if the cough is not cured for a long time and changes from acute to chronic, the patient often suffers from great pain, such as chest distress, throat itching, suffocating and panting, intolerance of labor, and the like.

Cough is one of the most common symptoms in the clinic. In recent years, epidemiological investigations have found that the incidence of cough is generally above 10%. Because the disease is not classified into age and sex, and the disease course is often long, the disease attacks repeatedly and is not cured, great attention has been paid to people at present.

The treatment principle of treating cough in western medicine is mainly symptomatic treatment, and most of the treatment means are cough relieving, phlegm eliminating by atomization, oral or intravenous application of antibiotics, antiviral drugs and the like aiming at cough or symptoms accompanied by expectoration, fever, sore throat, suffocating asthma, nasal obstruction, watery nasal discharge, headache and body pain or constipation and the like. Various antibiotics are frequently used by many cough patients repeatedly, so that overuse and drug resistance of the antibiotics are caused, part of drugs have obvious gastrointestinal reaction with toxic and side effects of liver and kidney, and western medicines applied to part of patients, particularly patients with virus infectious cough, are high in treatment price and not obvious in effect.

The treatment of cough with traditional Chinese medicine is well known in Huangdi's inner Jing. According to the traditional Chinese medicine, cough is divided into types of wind-heat affecting lung, wind-cold affecting lung, wind-dryness affecting lung, phlegm-heat stagnating lung, phlegm-dampness accumulating lung, liver-fire affecting lung, lung-yin deficiency and the like, diagnosis and treatment are often carried out according to syndrome differentiation, generally, methods of dispelling cold, clearing heat, moistening dryness, dispelling wind, relieving urgency, ventilating lung, reducing phlegm, relieving sore throat, lowering stomach, purging liver, nourishing yin and the like are adopted, and at present, good effects are achieved.

Cough due to lung heat is a symptom mainly caused by stagnated heat in the lung and loss of dispersing and descending of the lung, and is commonly seen in children and the elderly with low immunity, and in the aspect of traditional Chinese medicine, cough due to lung heat belongs to warm disease. The disease can occur in the respiratory system diseases such as upper respiratory tract infection, acute and chronic bronchitis attack, acute pneumonia and the like in modern medicine.

According to the traditional Chinese medicine, the cough caused by lung heat is frequently done, and the cough is more frequent or less difficult to expectorate because of excessive phlegm and heat generation of the lung and the lung loses the dispersing and purifying effect due to the excessive phlegm. The clinical manifestations are repeated cough or accompanied by symptoms such as expectoration, fever, sore throat, suffocating and dyspnea, nasal obstruction and running nose, headache and body pain or constipation, red tongue, thin yellow or yellow greasy coating, flat pulse and/or rapid pulse. For cough due to lung heat, it is advisable to ventilate lung and clear heat, relieve cough and resolve phlegm.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for treating lung-heat cough, which comprises ephedra, almond, gypsum, liquorice, honeysuckle, houttuynia cordata, fructus forsythiae, scutellaria baicalensis, cortex mori radicis, thunberg fritillary bulb, radix peucedani, radix asteris, platycodon grandiflorum and fructus aurantii.

Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight:

further preferably, the traditional Chinese medicine composition comprises the following components in parts by weight:

preferably, the Chinese ephedra in the Chinese medicinal composition is raw Chinese ephedra, almond is fried almond, liquorice is prepared licorice, and bitter orange is fried bitter orange.

The second purpose of the invention is to provide other uses of the traditional Chinese medicine composition, namely:

the application of the Chinese medicinal composition in preparing medicine for treating cough or one or more symptoms accompanied with expectoration, fever, sore throat, suffocating asthma, nasal obstruction, watery nasal discharge, headache and body pain or constipation, etc.

The application of the traditional Chinese medicine composition in preparing a medicine for treating bronchitis; preferably, the bronchitis refers to acute bronchitis caused by bacterial or viral infection.

The application of the traditional Chinese medicine composition in preparing a medicine for treating pneumonia; preferably, the pneumonia is pneumonia caused by bacterial or viral infection.

The invention also aims to provide a traditional Chinese medicine preparation containing the traditional Chinese medicine composition. Specifically, the traditional Chinese medicine preparation is prepared from the traditional Chinese medicine composition and pharmaceutically available auxiliary materials according to a conventional preparation method, and the traditional Chinese medicine preparation can be one or more of granules, tablets, pills, capsules and liquid oral preparations; preferably, the liquid oral preparation can be one or more of syrup, oral liquid and mixture; further preferably, the traditional Chinese medicine preparation is oral liquid or granules.

Compared with the prior art, the invention has the following remarkable advantages:

the traditional Chinese medicine composition can ventilate lung, clear heat, relieve cough and reduce sputum; can effectively treat cough with lung heat, can be used for treating cough or symptoms such as expectoration, fever, sore throat, suffocating asthma, nasal obstruction, watery nasal discharge, headache and body pain or constipation, can be used for treating red tongue, thin yellow or yellow greasy tongue coating, flat pulse and/or rapid pulse, can be used for treating bacterial infectious acute bronchitis or pneumonia, can also be used for treating viral infectious acute bronchitis or pneumonia, and has wide application range and definite curative effect.

DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION

The technical solution of the present invention will be clearly and completely described below with reference to specific embodiments, but the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments obtained by a person skilled in the art without making any inventive step are within the scope of protection of the present invention.

Example 1

The formula is as follows:

the preparation method comprises the following steps: the Chinese medicinal materials are decocted by 4000ml of water, and supernatant fluid is taken and concentrated to obtain the traditional Chinese medicine.

Example 2

The formula is as follows:

Example 3

The formula is as follows:

the preparation method comprises the following steps: decocting the Chinese medicinal materials with 4000ml of water, collecting supernatant, and concentrating.

Example 4

The formula is as follows:

Example 5

The formula is as follows:

Example 6

The formula is as follows:

the preparation method comprises the following steps: the Chinese medicinal materials are decocted by 8000ml of water, and supernatant is taken and concentrated to obtain the traditional Chinese medicine.

Comparative example 1

The formula is as follows:

the preparation method comprises the following steps: the Chinese medicinal materials are decocted by 4000ml of water, and supernatant is taken to obtain the Chinese medicinal composition.

Comparative example 2

The formula is as follows:

the preparation method comprises the following steps: the Chinese medicinal materials are decocted by 4000ml of water, and supernatant fluid is taken and concentrated to obtain the traditional Chinese medicine. Comparative example 3:

the formula is as follows:

the preparation method comprises the following steps: the Chinese medicinal materials are decocted by 4000ml of water, and supernatant fluid is taken and concentrated to obtain the traditional Chinese medicine. Comparative example 4:

the formula is as follows:

the preparation method comprises the following steps: the Chinese medicinal materials are decocted by 4000ml of water, and supernatant fluid is taken and concentrated to obtain the traditional Chinese medicine. Comparative example 5:

the formula is as follows:

Comparative example 6:

the formula is as follows:

ephedra herb 240g apricot kernel 180g honey-fried licorice root 120g plaster stone 480g

Comparative example 7:

the formula is as follows:

the preparation method comprises the following steps:

(1) weighing Bulbus Fritillariae Thunbergii according to the proportion of the formula, and pulverizing into fine powder;

(2) weighing herba Ephedrae, fructus forsythiae, Scutellariae radix, semen Armeniacae amarum, rhizoma Pinelliae, fructus Arctii, and radix et rhizoma Rhei according to the proportion of the formula, adding 50% ethanol, reflux extracting for 2 times, each for 3 hr, 10 times for the first time, 6 times for the second time, mixing the extractive solutions, filtering, recovering ethanol from the filtrate under reduced pressure, concentrating to obtain fluid extract with relative density of 1.15 at 60 deg.C;

(3) weighing gypsum, cortex mori radicis, radix peucedani, pericarpium citri reticulatae, lonicerae flos, platycodon grandiflorum and liquorice according to the proportion of the formula, adding water for decocting twice, 2 hours each time, 10 times of the amount of the water for the first time and 7 times of the amount of the water for the second time, combining the decoctions, filtering, concentrating under reduced pressure to obtain a clear paste with the relative density of 1.15 measured at 60 ℃, and combining the clear paste obtained in the step (2) for later use;

(4) mixing the fluid extracts obtained in the step (3), spray-drying, and collecting spray powder for later use;

(5) tabletting, wherein the raw materials are as follows by weight: 282.6 parts of spray powder obtained in the step (4), 101 parts of fine powder obtained in the step (4), 12.5 parts of carboxymethyl starch sodium, 9.0 parts of microcrystalline cellulose, 2.25 parts of magnesium stearate and a proper amount of starch are taken; making into tablet by conventional method.

Pharmacodynamic test

In order to verify the efficacy of the traditional Chinese medicine composition, the inventor carries out pharmacodynamic test research. It should be noted that the medicine selected in the pharmacodynamic test of the medicine of the present invention is the medicine obtained by the representative formula and the preparation method of the present invention, and the present invention also selects a part of experiments to describe the technical effects. The present inventors have conducted the same studies to achieve the same or similar results for drugs derived from other formulations encompassed by the present invention and other conditions described herein, which are not necessarily exhaustive due to space limitations.

The following experimental studies are carried out on the basis of the safety of the drug proved by acute toxicity tests and long-term toxicity tests, and the administration dose in the experimental studies is within the safe dose range.

Example 1 research on drug effect of the Chinese medicinal composition on acute bronchitis rats

1.1 animal modeling, grouping and administration

SPF grade healthy SD rats, 60, male and female halves, body weight (200 ± 20) g, experimental animal license number: SYXK (lu) 20180008. The method is characterized in that the animal is bred adaptively for 1 week in a clean-grade animal laboratory before experiment, male and female parts are separated, the room temperature is 20-25 ℃, the relative humidity is 40% -60%, natural illumination is carried out, and free food intake and drinking are carried out.

The molding method comprises the following steps: the rats are placed in a sealed glass container, and 10g of sawdust is added into 20 cigarettes each time, and the mixture is smoked for 30min each time for 2 times/d for 15 days. At 15d, taking 50 successfully molded rats, and randomly dividing the rats into a model group, a low-dose group in example 6, a high-dose group in example 6, a group in comparative example 6 and a group in comparative example 7, wherein each group comprises 10 rats; the rats were housed in a blank group of 10 rats in a normal smokeless environment. The rats in each group adopt the gastric perfusion administration mode. The medicine is taken continuously for 3 days.

The following doses were administered to each group of animals:

example 6 low dose group: 0.4ml/g, 20.7g crude drug amount/ml;

example 6 high dose group: 0.4ml/g, 62.1g crude drug amount/ml;

comparative example 6 group: 0.4ml/g, 23.0g crude drug amount/ml;

comparative example 7 group: 0.4ml/g, 30.3g crude drug amount/ml;

blank group: an equal volume of saline;

model group: an equal volume of saline.

1.2 index detection method

1.2.1 changes in the number of coughs in rats: rats were observed and the change in cough frequency within 10min after the 15 th and the last dose of rats was recorded.

1.2.2 granulocyte assay: taking a proper amount of bronchoalveolar lavage fluid, and placing the bronchoalveolar lavage fluid in a high-energy blood conventional detector to detect the white blood cell count, the neutrophil count and the alveolar macrophage count.

1.3 statistics of the results of the experiment

Statistical methods data were processed using SPSS statistical software. The experimental results are expressed in terms of mean and standard deviation (X +/-s), and the difference between groups is compared by adopting one-way variance analysis, wherein P <0.05 represents that the difference has statistical significance.

2.1 results of the experiment

2.1.1 general case observations:

after the model group rats begin to model, compared with the blank control group rats, the activity of the model group rats is obviously reduced, the reaction is slow and tired, and after 15 days, the coat gloss of the model group rats is gradually lost, cough, audible wheezing and phlegm wheezing are heard in lung auscultation, and the differences are obvious from the blank group rats. After administration, the cough symptom of rats in each experimental group is relieved to different degrees, and the airway wheeze and phlegm wheeze are relieved to different degrees, wherein the general condition of the rats in the high-dose group is most similar to that of the rats in the normal control group.

2.1.2 Effect of rat cough frequency:

as shown in Table 1, compared with the model group, the cough frequency of rats in each administration group is reduced after administration, and the cough frequency of rats in the high-dose group and the low-dose group of the traditional Chinese medicine composition is obviously reduced and is obviously superior to that of other control groups.

TABLE 1 Effect on the number of coughs in rats

Group of	Sample size (only)	Modeling No. 15d (cough times)	Last dose for 1h (cough times)
				Blank group	10	0^##	0^##
Model set	10	35.2±3.7	35.5±2.7
				Example 6 Low dose group	10	34.9±3.2	12.2±2.9^##&**
Example 6 high dose group	10	35.8±4.6	9.8±3.0^##&&**
				Comparative example 6 group	10	35.9±3.9	15.7±2.2^##
Comparative example 7 group	10	34.8±4.1	16.3±2.3^##

Compared with the model control group,^#P<0.05，^##P<0.01; in comparison with the group of comparative example 6,^&P<0.05,^&&P<0.01; (ii) a P compared with comparative example 7 group<0.05,^**P<0.01。

2.1.3 Effect of leukocyte count and neutrophil, alveolar macrophage ratio in bronchoalveolar lavage fluid:

as shown in Table 2, the white blood cell count and the proportion of neutrophils and alveolar macrophages in the bronchoalveolar lavage fluid of the model rat are significantly increased compared with the normal control group.

Compared with the model group, the white blood cell count and the proportion of neutrophils and alveolar macrophages in the bronchoalveolar lavage fluid of the rats in each administration group are obviously reduced. Compared with the comparative example group, the high-dose group and the low-dose group have significant differences in the effects of white blood cell count, neutrophil and lung macrophage.

TABLE 2 influence of the white blood cell count and the neutrophil, alveolar macrophage ratio in bronchoalveolar lavage fluid

Group of	White blood cell (× 10)⁸/L)	Neutrophilic granulocytes/%)	Alveolar macrophage/%
				Blank group	4.03±0.36	18.36±1.34	15.40±1.50
Model set	6.99±0.73	48.71±3.40	44.22±2.71
				Example 6 Low dose group	3.99±0.67^##&&**	23.19±3.68^##&&**	25.32±2.88^##*
Example 6 high dose group	3.73±0.56^##&&**	21.09±1.88^##&&**	22.35±2.86^##&&**
				Comparative example 6 group	4.80±0.60^##	28.39±4.60^##	27.22±3.14^##
Comparative example 7 group	4.97±0.45^##	29.50±4.00^##	28.32±3.19^##

Compared with the model control group,^#P<0.05，^##P<0.01; in comparison with the group of comparative example 6,^&P<0.05,^&&P<0.01; p compared with comparative example 7 group<0.05,^**P<0.01。

Example 2 Effect on a mouse model of Streptococcus pneumoniae pneumonia

1 Material

1.1 experiment animal SPF level mouse, weight 18 ~ 22g, license number: SYXK 20170006, available from food and drug testing and testing center of Jinlin; the method is characterized in that the breeding is carried out adaptively for one week before the experiment, the breeding is naturally illuminated, drinking water is freely taken, the room temperature is controlled to be 20-26 ℃, and the relative humidity is controlled to be 45-65%. The feeding was carried out in a conventional manner during the test.

1.3 drugs and reagents

Streptococcus pneumoniae, bio-technology ltd for shit diagnosis in south kyo;

the following doses were administered to each group of animals:

example 6 low dose group: 0.4ml/g, 29.9g crude drug amount/ml;

example 6 high dose group: 0.4ml/g, 87.0g crude drug amount/ml;

comparative example 6 group: 0.4ml/g, 32.2g crude drug amount/ml;

comparative example 7 group: 0.4ml/g, 42.4g crude drug amount/ml;

normal control group: an equal volume of saline;

model control group: an equal volume of saline.

2 method

2.1 Molding and administration

After 1 week of adaptive feeding, 10 mice were inoculated intranasally with 0.1mL of 6X 10 mice from each group of model control group, high dose group, low dose group, comparative example 6 group, comparative example 7 group, and the like, except for normal control group, in each case in a random group of 10 mice under light ether anesthesia⁸CFU/mL Streptococcus pneumoniae was maintained at 45 ℃ for 30s after inoculation, and was inoculated continuously for 3d, and normal control mice were inoculated with an equal amount of physiological saline.

The administration is started after 1 hour of nasal drip molding, and the administration is performed for 1 time by intragastric administration every day and for 6 days continuously. The mice in the control group and the model group are subjected to intragastric administration with the same volume of physiological saline.

2.2 Experimental procedures

(1) And (3) lung index determination:

weighing after the last administration for 1h, fully taking blood, killing the mouse by dislocation of cervical vertebra, dissecting, sucking the surface moisture of the lung leaves with filter paper, weighing, calculating the lung wet weight, and calculating the lung index according to the following formula:

lung index ═ lung wet weight (mg)/body weight (g).

(2) Pathological examination of lung tissues:

left lung was cut and fixed in 10% formalin for histopathological examination

(3) Lung homogenate IL-6, TNF- α assay:

after weighing, the mice lungs were homogenized, centrifuged to take the supernatant, and the IL-6 and TNF- α values were determined according to the kit instructions.

2.3 statistical methods data were processed using SPSS statistical software. The experimental results are expressed in terms of mean and standard deviation (X +/-s), and the difference between groups is compared by adopting one-way variance analysis, wherein P <0.05 represents that the difference has statistical significance.

3 results

3.1 general observations

Compared with the normal control group, the mouse in the model group has reduced activity, reduced feed and water intake, crinkled fur, lusterless fur and obviously raised body temperature. The mice in the low-dose group and the high-dose group have stronger vitality than the mice in the model group, the food intake and the water intake are increased compared with the mice in the model group, and the differences from the mice in the normal control group are not obvious.

3.2 Change in pulmonary index of mice in groups

The lung index is the ratio of the lung weight to the body weight of the mouse, and a larger value indicates a more serious degree of lung lesion. The results are shown in Table 3:

TABLE 3 change in pulmonary index of mice

Group of	Animal number (only)	Lung index (mg/g)
			Normal control group	10	8.12±0.13^##
Model control group	10	10.52±0.21
			Example 6 Low dose group	10	8.67±0.26^##&&**
Example 6 high dose group	10	8.12±0.27^##&&**
			Comparative example group 6	10	9.02±0.28^##
Comparative example group 7	10	9.02±0.37^##

Compared with the model control group,^#P<0.05，^＃＃P<0.01; in comparison with the group of comparative example 6,^&P<0.05,^&&P<0.01; (ii) a P compared with comparative example 7 group<0.05,^**P<0.01。

Compared with the normal group, the lung index of the model group mouse is obviously increased, which indicates that the model group lung injury model is established and inflammatory change lung diseases such as obvious edema of the lung become serious; after 6 days of intragastric administration, the pulmonary index of each experimental group is reduced, wherein the reduction trend of the high-dose group is most obvious and is closer to the pulmonary index of the normal group of mice.

3.3 pathological examination of lung tissues:

the pathological examination result of the left lung tissue shows that the alveoli of the mice in the normal control group have clear shapes, complete structures, no blood seepage and no obvious abnormality of the interstitium; the model group mice have atrophic and deformed alveoli, and a large number of cells in the alveoli are infiltrated, which indicates that the mice have serious inflammation. The symptoms of each administration group are obviously relieved, particularly, the pulmonary alveoli of the high-dose group of the traditional Chinese medicine composition have clear outline and almost no bleeding phenomenon, a small amount of cells are infiltrated in the pulmonary alveoli, and the inflammation symptoms are obviously relieved.

3.4 measurement of IL-6 and TNF-alpha values of lung homogenate inflammatory factors

The values of IL-6 and TNF-alpha in the lung homogenates of the mice of each group were determined according to the kit requirements, and the results are shown in Table 4:

TABLE 4 measurement of lung homogenate inflammatory factor IL-6 and TNF-alpha values in each group of mice

Group of	Animal number (only)	IL-6(ng/mL)	TNF-α(pg/mL)
				Normal control group	10	0.21±0.01^＃＃	20.70±0.49^＃＃
Model control group	10	21.40±2.02	149.00±8.06
				Example 6 Low dose group	10	0.85±0.26^＃＃&&**	25.46±4.51^＃＃&&**
Example 6 high dose group	10	0.50±0.22^＃＃&&**	21.39±2.29^＃＃&&**
				Comparative example group 6	10	2.29±0.42^＃＃	34.90±4.28^＃＃
Comparative example group 7	10	2.85±0.40^##	40.20±4.21^##

As shown in the results of Table 4, the results of inflammatory factors in lung homogenate show that compared with the control of a normal group, the contents of IL-6 and TNF-alpha in the lung homogenate of a model group mouse are obviously increased, and after one week of gastric lavage administration, the low dose and the high dose of the traditional Chinese medicine composition can obviously inhibit the secretion of the inflammatory factors IL-6 and TNF-alpha in the serum of the mouse.

Clinical medicine

First, the traditional Chinese medicine composition of the invention has the treatment effect on cough with lung heat

1 clinical data

1.1 general data

Cough patients in outpatients and institutes of residence of the hospital are selected from 30 patients with cough with lung heat diagnosed by traditional Chinese medicine in the period from 11 months to 1 month in 2018 to 2019.

1.2 diagnostic criteria

(1) The main symptoms are: cough, expectoration;

(2) the secondary symptoms are as follows: fever, sore throat, suffocating asthma, nasal obstruction, watery nasal discharge, headache and body pain, constipation;

(3) tongue pulse: a red tongue with thin yellow or yellow greasy coating and a flat and or rapid pulse.

1.3 inclusion criteria

(1) The syndrome differentiation standard of the lung-heat cough in the traditional Chinese medicine is met;

(2) the patient is 45 days to 84 years old;

(3) signing the informed consent.

1.4 exclusion criteria

(1) Severe complications (e.g., heart failure, empyema, pneumothorax, pleural effusion, etc.);

(2) severe malnutrition, rickets, asthma, severe primary or wasting diseases such as heart, liver, kidney and hematopoietic system;

(3) children with congenital immune diseases or lung dysplasia, swallowing dysfunction, etc.;

(4) those who are participating in clinical trials with other drugs;

(5) those allergic to the study drug or other drugs;

2 test method

2.1 grouping

The 30 patients who met the above criteria were divided into 2 groups according to the random table: 15 test groups and 15 control groups.

2.2 methods of treatment

(1) Test groups: xuan Qing Hua Tang is indicated.

The medicine comprises the following components: ephedra, almond, gypsum, liquorice, honeysuckle, houttuynia cordata, fructus forsythiae, scutellaria baicalensis, cortex mori, thunberg fritillary bulb, radix peucedani, aster, platycodon grandiflorum and fructus aurantii.

The taking method comprises the following steps: one dose of the medicine is decocted with water to obtain 400ml, the medicine is warm taken twice after meals in the morning and at night, the medicine is continuously taken for 7 days, and the patient is subjected to the double-diagnosis after 7 days.

(2) Control group: and adding Ma xing Shigan Tang.

The medicine comprises the following components: ephedra, almond, liquorice and gypsum.

3. Results of the experiment

3.1 Observation and detection index

The Chinese medicine symptom scores (Chinese medicine single symptom score and symptom sign observation) of the patients on the 0 th day, the 4 th day and the 7 th day after the patients take the medicine are recorded respectively.

3.2 therapeutic efficacy determination and evaluation criteria

3.2.1 therapeutic efficacy assessment Table

A Chinese medicine syndrome grading quantitative standard table is set according to the standard in the Chinese medicine new drug clinical research guiding principle.

3.2.2 evaluation criteria for therapeutic Effect

The method is formulated according to the therapeutic effect evaluation standard in the clinical research guiding principles of new traditional Chinese medicines:

(1) and (3) healing: clinical symptoms and physical signs of the traditional Chinese medicine basically disappear, and the syndrome integral is reduced by more than or equal to 95 percent;

(2) the effect is shown: the clinical symptoms and physical signs of the traditional Chinese medicine are obviously improved, and the syndrome integral is reduced by 95 to 70 percent;

(3) the method has the following advantages: the clinical symptoms and physical signs of the traditional Chinese medicine are improved, and the syndrome integral is reduced by 70-30%;

(4) and (4) invalidation: the clinical symptoms and physical signs of the traditional Chinese medicine are not obviously improved or even aggravated, and the syndrome integral is reduced by less than 30 percent.

Effective rate (cure + effect + effective)/total number x 100%

3.3 statistical processing method

Sorting the finally recorded case data, establishing a database by using Excel software, inputting the data into statistical software SPSS22.0 for analysis, using t test for measuring data among groups, using chi-square test for counting data among groups, having statistical difference with P <0.05 and having statistical significance; p > 0.05 is no significant difference and has no statistical significance.

3.4 therapeutic results

3.4.1 symptom score comparison before and after treatment

As can be seen by comparison of statistical tests, on the 4 th day of treatment in the test group, the symptoms of cough, expectoration, fever, sore throat and suffocating asthma are improved to some extent compared with those before treatment; on the 7 th day of treatment in the test group, the symptoms of cough, expectoration, fever, sore throat and suffocating asthma are obviously improved compared with those before treatment (P is less than 0.05). The overall symptoms on day 4 and day 7 of treatment were significantly improved compared to those before treatment (P < 0.05).

TABLE 5 integral comparison of primary and secondary symptoms before and after treatment in two groups

Note: compared with the control group, the compound of the formula,^*P＜0.05。

3.4.2 comparison of the total curative effects of the two groups after treatment

TABLE 6 integral comparison of primary and secondary symptoms before and after treatment in two groups

Second, typical case

1. Li XX, male, 60 years old, first diagnosis in 2 months and 25 days of 2020.

The main complaints are: paroxysmal cough with expectoration accompanied by suffocating and asthma for 1 month. Cough of patients occurs repeatedly in nearly one month, the sputum is yellow, the patients feel suffocated slightly, cough due to the sputum is relieved, cough in the morning is obvious, foreign body sensation in throat is accompanied, the tongue is red, the tongue coating is white and greasy, and the pulse is rapid.

CT of chest shows: bronchitis;

blood routine shows that: white blood cells 8.08 × 109/L, lymphocyte percentage 23.9%, monocyte percentage 4.6%, neutrophil percentage 71.5%;

electrocardiogram representation: approximately normal blood pressure is 150/90mmHg, and the effect is not obvious after taking compound liquorice tablets, ketelin capsules, cough syrup, intravenous injection ambroxol injection, azithromycin injection, amoxicillin potassium clavulanate powder injection, diprophylline injection and the like for 7 days.

Traditional Chinese medicine diagnosis: cough, dialectical: phlegm-heat accumulating in the lung and failing to disperse and descend the lung, it is indicated for dispersing lung qi and clearing heat, relieving cough and resolving phlegm.

Prescription: raw ephedra, fried almond, gypsum, honey-fried licorice root, honeysuckle, houttuynia, forsythia, white mulberry root-bark, thunberg fritillary bulb, radix peucedani, radix asteris, platycodon root, fried fructus aurantii (the Xuanqing phlegm-resolving decoction of the embodiment 6 of the invention) 7 doses are decocted with 400ml of water each day and are taken warmly twice in the morning and at night, and patients are diagnosed repeatedly after 7 days, and cough, expectoration, suffocating asthma and foreign body sensation of pharynx disappear, which are the same as usual people.

2. Zhu XX, male, age 68, first diagnosis in 12 months and 4 days in 2018.

The main complaints are: paroxysmal cough with expectoration accompanied by nasal obstruction for more than 2 months. The tongue is red, the tongue coating is white and greasy, and the pulse is mild.

Chest DR shows: bronchitis;

blood routine shows that: 3.64 multiplied by 109/L of white blood cells, 32.7 percent of lymphocytes, 6.3 percent of monocytes and 57.1 percent of neutrophils;

electrocardiogram representation: the heart rate is 56 times/minute, the blood pressure is 150/90mmHg, the effects of taking tangerine peel granules, leucogen tablets, vitamin B4 tablets, lung-power cough mixture, azithromycin tablets, amoxicillin and potassium clavulanate tablets and the like are not obvious, and the patients can be cured after taking the medicine (the Xuanqing phlegm-resolving decoction of the embodiment 6 of the invention) for 8 days.

3. Grandson XX, female, age 52, first visit on 1/2 of 2019.

The main complaints are: the paroxysmal cough and the expectoration are more than 10 days. The tongue is red, the tongue coating is white and greasy, and the pulse is mild.

Chest DR shows: bronchitis;

blood routine shows that: 5.69 multiplied by 109/L of white blood cells, 23.4 percent of lymphocytes, 4.2 percent of monocytes and 68.6 percent of neutrophils;

electrocardiogram representation: the heart rate is 74 times/minute, the III lead T wave is flat, the blood pressure is 130/90mmHg, the effect is not obvious after the administration of tangerine peel capsules, promethazine tablets, azithromycin tablets and the like, the cough is relieved after the administration of the decoction (the Xuanqing phlegm-resolving decoction of the embodiment 6 of the invention) and the cough is cured after 4 doses.

4. Plum XX, female, 40 years old, in 2019, in first visit 1 month 2.

The main complaints are: paroxysmal cough with asthenia lasts for more than 10 days. The tongue is red, the tongue coating is white and greasy, and the pulse is mild.

Chest DR shows: bronchitis;

blood routine shows that: 9.06 multiplied by 109/L of white blood cells, 35.7 percent of lymphocytes, 5.4 percent of monocytes, 57.7 percent of neutrophils and 110/90mmHg of blood pressure, the medicine is not effective after being prepared for oral administration (the specific medicine is not detailed) in village health rooms for 7 days, the effect is not obvious after being infused for 3 days (the specific medicine is not detailed), and the patient can be cured by being given 6 doses of the Xuanqinghua phlegm-resolving decoction.

5. Zhang XX, male, 3 years old, first diagnosis in 2019, 1 month, 23 days.

The main complaints are: paroxysmal cough with hoarseness for more than 10 days. Body temperature 37.1 deg.C, red tongue with white and greasy coating, mild pulse.

Chest DR shows: bronchitis;

blood routine shows that: 5.93 multiplied by 109/L of white blood cells, 30.8 percent of lymphocytes, 12.5 percent of monocytes and 54.8 percent of neutrophils, which are not effective after being taken for 7 days (the specific medicine is not detailed), and the white blood cells are cured after being taken for 7 doses after being taken for a reduced amount (the Xuanqing phlegm-resolving decoction of the embodiment 6 of the invention).

6. King XX, male, 9 months, first diagnosis in 2019, 2 months and 21 days.

The main complaints are: paroxysmal cough with fever for 2 days, body temperature 39.1 ℃, red tongue, white and greasy tongue coating, mild pulse.

Chest DR shows: bronchitis;

blood routine shows that: 26.03 multiplied by 109/L of white blood cells, 17.3 percent of lymphocytes, 7.2 percent of monocytes, 75.2 percent of neutrophils and 94g/L of hemoglobin, wherein the cefaclor granules, the kechuanling granules and the compound zinc cloth granules which are taken by oneself are not effective in cooperation with infant tuina, and are taken in a decrement way (the Xuanqing phlegm-resolving decoction of the embodiment 6 of the invention) to heal the disease after 10 doses.

7. Zhao XX, male, 84 years old, first diagnosis in 2019, 2 months and 26 days.

The main complaints are: cough with sputum for 7 days. The tongue is red, the tongue coating is white and greasy, and the pulse is mild.

Chest DR shows: bronchopneumonia;

blood routine shows that: leukocyte 9.11 × 109/L, lymphocyte 17.3%, monocyte 5.9%, neutrophil 76.7%, electrocardiogram: heart rate 46 times/minute, aVL lead T wave level, blood pressure 160/90mmHg, infusion in village health room (detailed medicine is unknown) for 4 days, administration of the decoction (Xuanqing phlegm-resolving decoction of the invention in example 2) for relieving cough, and 12 doses for healing.

8. Wang XX, male, 20 years old, first diagnosis in 2020, 1 month, 27 days.

The main complaints are: paroxysmal cough accompanied by foreign body sensation in pharynx for 3 days. The effect is not obvious after 2 days of transfusion in a village sanitary room, the body temperature is 37.3 ℃, the tongue is red, the tongue coating is white and greasy, and the pulse is rapid.

Chest DR shows: bronchitis;

blood routine shows that: 10.87 multiplied by 109/L of white blood cells, 33 percent of lymphocytes, 1.6 percent of monocytes and 64.8 percent of neutrophils, and the composition is cured by 7 doses of Xuanqing phlegm-resolving decoction.

9. The medicine is taken by king XX, male, 5 years old, 2019-1-28, cough with fever for 3 days, body temperature of 37.6 ℃, stool for two days, normal body temperature, auscultation of phlegm and whitish sound of both lungs, thin and greasy tongue coating and rapid pulse, and the medicine is taken in a Xuanqing phlegm-resolving decoction amount-reducing way, and is cured after 6 days.

10. Zhao XX, male, 17 years old, doctor visits 2019-1-28, cough for half a month, doctor visits with fever for 1 day, body temperature 39.4 ℃, can be accommodated, adjusted for convenience, normal body temperature, auscultation, thick breathing sound of both lungs, thin and greasy tongue coating and rapid pulse, and the patient is given (the Xuanqing phlegm-resolving decoction of the embodiment 1 of the invention) to be matched with antipyretic to take the decoction for 7 days to heal the disease.

11. The traditional Chinese medicine is taken by king XX, male, 2 years old, and 2019-12-27 for diagnosis, cough with running nasal discharge for 2 days, body temperature of 37 ℃, auscultation of coarse breathing sound of two lungs, no smell of dry and wet rale, yellow and greasy tongue coating and rapid pulse, and is taken in a decrement way after being given (the Xuanqing phlegm-resolving decoction of the embodiment 2 of the invention) for 5 days.

12. XX, female, born for 45 days, diagnosed in 2018-6-17, cough acute, facial eczema, stool once every two days, normal body temperature, auscultation of phlegm and whitish sound of the two lungs, thin and greasy tongue coating and rapid pulse, and the patient can be cured after taking the decoction (the Xuanqing phlegm-resolving decoction of the invention in the embodiment 3) for 7 days.

Claims

1. A Chinese medicinal composition for treating cough due to lung heat comprises herba Ephedrae, semen Armeniacae amarum, Gypsum Fibrosum, Glycyrrhrizae radix, flos Lonicerae, herba Houttuyniae, fructus forsythiae, Scutellariae radix, cortex Mori, Bulbus Fritillariae Thunbergii, radix Peucedani, radix Asteris, radix Platycodi, and fructus Aurantii.

2. The use as claimed in claim 1, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:

3. the use as claimed in claim 1, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:

4. the use as claimed in claim 1, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:

5. the use of any one of claims 1 to 4, wherein the Chinese medicinal composition comprises herba Ephedrae, semen Armeniacae amarum preparata, radix Glycyrrhizae Preparata, and fructus Aurantii preparata.

6. Use of a Chinese medicinal composition according to any one of claims 1-4 in the preparation of a medicament for the treatment of cough or a condition associated with one or more of expectoration, fever, sore throat, dyspnea, nasal obstruction, watery nasal discharge, headache, body pain, or constipation.

7. Use of a Chinese medicinal composition according to any one of claims 1 to 4 in the manufacture of a medicament for the treatment of bronchitis; preferably, the bronchitis refers to acute bronchitis caused by bacterial or viral infection.

8. Use of a Chinese medicinal composition as claimed in any one of claims 1 to 4 in the preparation of a medicament for the treatment of pneumonia; preferably, the pneumonia is pneumonia caused by bacterial or viral infection.

9. A Chinese medicinal preparation prepared from the Chinese medicinal composition of any one of claims 1-8 and pharmaceutically acceptable adjuvants.

10. The traditional Chinese medicine preparation of claim 9, wherein the traditional Chinese medicine preparation is one or more of granules, tablets, pills, capsules and liquid oral preparations; preferably, the traditional Chinese medicine preparation is oral liquid or granules.