CN117159661A

CN117159661A - Traditional Chinese medicine composition, preparation and application thereof

Info

Publication number: CN117159661A
Application number: CN202311064184.3A
Authority: CN
Inventors: 李志刚
Original assignee: Suzhou Institute Of Traditional Chinese Medicine Co ltd
Current assignee: Suzhou Institute Of Traditional Chinese Medicine Co ltd
Priority date: 2023-08-15
Filing date: 2023-08-23
Publication date: 2023-12-05

Abstract

The application relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating cough after infection, which is prepared from 5-10 parts of radix stemonae, 3-9 parts of poria cocos, 5-10 parts of loquat leaf, 5-10 parts of aster, 10-18 parts of Japanese ardisia herb, 5-10 parts of burdock, 3-9 parts of ephedra herb, 3-9 parts of white paeony root and 1-5 parts of liquorice. The application also provides a traditional Chinese medicine compound preparation for treating cough after infection, and a preparation method and application thereof.

Description

Traditional Chinese medicine composition, preparation and application thereof

Technical Field

The application belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating cough after infection, a preparation and application thereof.

Background

Cough (postinfectious cough, PIC) after infection, which is usually caused by cold and has a symptom of acute phase that is disappeared but is not healed, has self-limiting and the course of the disease is usually not more than 2 months. After the symptoms of the cold in the acute stage disappear, the human body still has 'chronic cough', and the persistent cough is not healed, which causes trouble to daily life work. The disease course of many patients can be several months or even years, which seriously disturb the normal work, life and study of patients. Western medicine is mainly treated by adopting various modes such as central antitussive medicines, oral administration or aerosol inhalation hormones, antihistamine receptor antagonists, compound preparations and the like at present, but the following problems still exist: (1) The diagnosis procedure is complex, the cost is high, and the economic burden of a patient is increased; (2) the use of antibiotics in large quantities, resulting in abuse; (3) The hidden trouble of overlarge side effects exists in medicines due to the lack of effective and safe treatment schemes.

Cough disease is first seen in internal diameter. "Su Wen" indicates that cough is caused by pathogenic factors in skin and hair, and cough is caused by internal organs, not by lung alone. Emphasizes that the pathogenesis should be cold, summer-heat, dryness, dampness, wind and fire six exogenous pathogenic factors attack the lung system or viscera dysfunction, which leads to internal injury of the lung system and failure of the lung to disperse and descend, thus the lung qi is reversed upwards and impacts the airway to cause cough. The modern Chinese medical science combines the clinical symptoms of cough, and the cough after infection is considered to be in the category of 'chronic cough and stubborn cough' in the traditional Chinese medicine, and although exterior syndrome is relieved, the exogenous evil is not removed, and the lung is in disorder in dispersing and descending, so that the cough is not healed. Many traditional Chinese medicines have extremely high pharmacological effects of resisting viruses, relieving cough, reducing sputum, moistening lung, diminishing inflammation and the like. The traditional Chinese medicine has the advantages of definite curative effect, no obvious adverse reaction, long-term administration and the like after treating the cough after infection, and has good application prospect.

Disclosure of Invention

The application aims to provide a traditional Chinese medicine composition for treating cough after infection, and a preparation and application thereof.

The application provides a traditional Chinese medicine composition for treating cough after infection, which is prepared from the following raw materials in parts by weight: 5-10 parts of radix stemonae, 3-9 parts of poria cocos, 5-10 parts of folium eriobotryae, 5-10 parts of aster, 10-18 parts of Japanese ardisia herb, 5-10 parts of burdock, 3-9 parts of ephedra, 3-9 parts of white paeony root and 1-5 parts of liquorice.

In a preferred embodiment, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 7-9 parts of radix stemonae, 4-7 parts of poria cocos, 7-9 parts of folium eriobotryae, 6-9 parts of aster, 13-17 parts of Japanese ardisia herb, 7-9 parts of burdock, 5-7 parts of ephedra, 5-7 parts of white paeony root and 2-4 parts of liquorice.

In a preferred embodiment, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5 parts of radix stemonae, 9 parts of poria cocos, 10 parts of loquat leaves, 6 parts of aster, 10 parts of Japanese ardisia herb, 5 parts of burdock, 9 parts of ephedra herb, 3 parts of white paeony root and 2 parts of liquorice.

In another preferred example, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 parts of radix stemonae, 7 parts of poria cocos, 7 parts of folium eriobotryae, 5 parts of aster, 13 parts of Japanese ardisia herb, 8 parts of burdock, 7 parts of ephedra herb, 5 parts of white paeony root and 5 parts of liquorice.

In another preferred example, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 9 parts of radix stemonae, 6 parts of poria cocos, 9 parts of folium eriobotryae, 9 parts of aster, 15 parts of Japanese ardisia herb, 9 parts of burdock, 6 parts of ephedra herb, 6 parts of white paeony root and 3 parts of liquorice.

In another preferred example, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 7 parts of radix stemonae, 4 parts of poria cocos, 8 parts of folium eriobotryae, 10 parts of aster, 18 parts of Japanese ardisia herb, 10 parts of burdock, 5 parts of ephedra herb, 7 parts of white paeony root and 1 part of liquorice.

In another preferred example, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 8 parts of radix stemonae, 3 parts of poria cocos, 5 parts of loquat leaves, 7 parts of aster, 17 parts of Japanese ardisia herb, 7 parts of burdock, 3 parts of ephedra herb, 9 parts of white paeony root and 4 parts of liquorice.

The second aspect of the application provides a traditional Chinese medicine compound preparation for treating cough after infection, which is decoction, granules, capsules, tablets, oral liquid or syrup taking the traditional Chinese medicine composition as an active ingredient.

In a preferred embodiment, the compound Chinese medicinal preparation is a granule.

The application also provides application of the traditional Chinese medicine composition in preparation of medicines for treating cough after infection.

Details of the various aspects of the application will be described in detail in subsequent sections. The features, objects, and advantages of the application will be apparent from the description, and from the claims.

Detailed Description

The traditional Chinese medicine raw materials adopted in the preparation process of the pharmaceutical composition have the following sources: stemona sessilifolia (miq.) miq.the Stemona sessilifolia (Bl.) miq. Or Stemona tuberosa (Stemona japonica) or Stemona tuberosa lour. Poria cocos (Poria cocos, polyporaceae) fungus Poriaccos (Schw.) Wolf. Dried leaves of Eriobotrya japonica leaf, eriobotrya japonica Eriobotrya japonica (thunder.) Lindl. Dried roots and rhizomes of Aster, aster l.f. Dried whole herb of Ardisia japonica (thunder.) Blume of Ardisia japonica (Thunb.) of Ardisiaceae. Dried mature fruit of Arctium lappa L. Herba Ephedrae, herba Ephedrae Ephedra sinicaStapf, herba Ephedrae Ephedra intermediaSchrenk et C.A.Mey. Or herba Equiseti hiemalis, ephemra equisetinaBge. Dried root of Paeonia lactiflora pall. Glycyrrhrizae radix, glycyrrhrizae radix of Leguminosae, glycyrrhrizae radix Glycyrrhiza uralensis Fisch. Glycyrrhiza glabra Bat. Or Glycyrrhrizae radix Glycyrrhiza glabra L. Dry root and rhizome.

Based on years of clinical practice experience, the inventor considers that exogenous six exogenous pathogenic factors can be the causative factor of the disease. Cough with Chinese angelica is in the category of 'chronic cough and stubborn cough' in traditional Chinese medicine after infection, and although exterior syndrome is relieved, exogenous evil is not removed, and lung is in disorder in dispersing and descending functions, so cough persists. The traditional Chinese medicine composition disclosed by the application contains ten traditional Chinese medicines in total. The Stemona root is a monarch drug for moistening lung, descending qi and relieving cough. Herba Ardisiae Japonicae has effects of eliminating phlegm, relieving cough, and removing dampness and heat; loquat leaves clear lung and relieve cough, and reduce adverse flow of qi and arrest vomiting; aster moistens lung and reduces qi, eliminates phlegm and relieves cough; poria cocos has effects of invigorating spleen and promoting diuresis, and is used for hilling up and producing gold; the four medicines are taken as ministerial medicines, and the monarch-assisting medicine enhances the cough relieving effect. Herba Ephedrae can induce sweat and dispel cold, free lung and relieve asthma, and disperse pathogenic wind in lung. Fructus Arctii has effects of dispelling pathogenic wind and heat, dispersing lung qi, removing toxic substances, relieving sore throat, and enhancing pathogenic wind dispelling effect together with herba Ephedrae; the three ingredients are used together as adjuvant drugs for nourishing blood and regulating menstruation, astringing yin and stopping sweat and preventing the ephedra from dispersing too much. Licorice root, radix Glycyrrhizae Praeparata has the effects of invigorating spleen and replenishing qi, clearing away heat and toxic materials, eliminating phlegm and relieving cough, and harmonizing the drugs, and is a guiding drug. Meanwhile, most of the medicinal ingredients in the formula are honey-roasted decoction pieces, so that the effects of tonifying qi and regulating middle warmer and relieving cough are enhanced. The medicines are compatible, and have the effects of moistening lung, resolving phlegm, relieving cough, clearing heat and strengthening spleen, and the effects of removing dampness and heat, moistening lung, resolving phlegm and relieving cough are achieved.

The pharmaceutical compositions of the application may be prepared by methods conventional in the art, for example: decocting nine materials such as radix Stemonae with 10 times of water for 2 times each for 1.5 hr, filtering, mixing filtrates, and concentrating the filtrate under reduced pressure to obtain fluid extract; centrifuging, concentrating the supernatant under reduced pressure to obtain extract with relative density of 1.20-1.30, and drying.

The traditional Chinese medicine composition disclosed by the application is convenient to use, definite in curative effect, small in side effect and low in cost, can be taken for a long time, and has a good clinical curative effect on treating cough after infection. In view of the long duration of the disease, even up to months or years, the disease severely interferes with the daily life of the patient. The traditional Chinese medicine composition has different therapeutic effects, such as hormone, antihistamine medicines and the like, and has the limitations of complex diagnosis procedures, higher cost and large side effects, so the traditional Chinese medicine composition has good clinical application prospect.

The application will be further illustrated with reference to specific examples. It is to be understood that these examples are illustrative of the present application and are not intended to limit the scope of the present application. The experimental procedures, which do not address the specific conditions in the examples below, are generally carried out under conventional conditions or under conditions recommended by the manufacturer. All percentages, ratios, proportions, or parts are by weight unless otherwise indicated.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In addition, any methods and materials similar or equivalent to those described herein can be used in the methods of the present application. The preferred methods and materials described herein are presented for illustrative purposes only.

The above-mentioned features of the application, or of the embodiments, may be combined in any desired manner. All of the features disclosed in this patent specification may be combined with any combination of the features disclosed in this specification, and the various features disclosed in this specification may be substituted for any alternative feature serving the same, equivalent or similar purpose. Thus, unless expressly stated otherwise, the disclosed features are merely general examples of equivalent or similar features.

Example 1

5g of radix stemonae, 9g of poria cocos, 10g of loquat leaves, 6g of aster, 10g of Japanese ardisia herb, 5g of burdock, 9g of ephedra herb, 3g of white paeony root and 2g of liquorice.

The preparation method comprises the following steps: adding 10 times of water into nine medicines such as radix stemonae, decocting twice for 1.5 hours each time, filtering decoction, and concentrating filtrate under reduced pressure to obtain clear paste; centrifuging, concentrating the supernatant under reduced pressure to obtain extract with relative density of 1.20-1.30, drying, adding adjuvants, and granulating.

The administration method is as follows: the granules are dissolved in water and then orally administered.

Example two

Taking 10g of radix stemonae, 7g of poria cocos, 7g of folium eriobotryae, 5g of aster, 13g of Japanese ardisia herb, 8g of burdock, 7g of ephedra herb, 5g of white paeony root and 5g of liquorice.

The preparation method and the administration method are the same as in example one.

Example III

9g of radix stemonae, 6g of tuckahoe, 9g of loquat leaf, 9g of aster, 15g of Japanese ardisia herb, 9g of burdock, 6g of ephedra, 6g of white paeony root and 3g of liquorice are taken.

Example IV

7g of radix stemonae, 4g of poria cocos, 8g of folium eriobotryae, 10g of aster, 18g of Japanese ardisia herb, 10g of burdock, 5g of ephedra herb, 7g of white paeony root and 1g of liquorice.

Example five

8g of radix stemonae, 3g of poria cocos, 5g of loquat leaves, 7g of aster, 17g of Japanese ardisia herb, 7g of burdock, 3g of ephedra herb, 9g of white paeony root and 4g of liquorice.

Example six animal experiments with Chinese medicinal composition for treating cough after infection

Experimental animals: SD rat

Experimental drugs: the experimental method for preparing the traditional Chinese medicine composition comprises the following steps of: the animals were selected from 4-week-old male and SD rats, and after one week of adaptive breeding, they were randomly classified into normal group, model group and drug group. The animals are placed in a whole body exposure atomization system and ventilated at a certain air flow speed, a metal smoking box (sawdust cigarette) is placed in an exposure box to be smoked, the smoking is carried out for 60min each day, the smoking is carried out for 12 days continuously, and the normal group onlyVentilation does not produce smoke stimulation. After smoking, rats were weighed, and after all rats except normal group rats on days 12, 13, 14, 16 and 19 were shallow, 0.4mg/ml concentration of Lipopolysaccharide (LPS) solution was added dropwise via nose, and the administration volume was 10. Mu.l/10 g, and normal group was replaced with normal saline. From day 14, each group of rats was given a daily intragastric administration according to the experimental design for 7 consecutive days. At the same time, the 14 th, 15 th, 17 th, 18 th and 20 th days, rats are placed in a transparent airtight exposure box for 10 th ^-4 The mol/L capsaicin solution is sprayed into cough at an output atomizing speed of 0.037ml/min for 15min each time, and 1 time a day. The number of coughs and cough latency were recorded at day 14 and day 20 when cough was stimulated.

Specific observation and inspection metrics in the test include the following:

(1) Times of cough and cough latency period

On day 1 (14 d) and day last (20 d) of the intragastric administration, rats were placed in a transparent closed exposure box 1 hour after administration and cough was stimulated by aerosol inhalation of 10-4mol/L capsaicin solution for 15 minutes, and after the end of the spraying, the interior of the exposure box was evacuated for the first 2 minutes to atomize the aerosol, and after two minutes, the time of primary cough (cough latency) and the number of coughs within 15 minutes of the rats were observed.

(2) Alveolar lavage fluid cytology assay

Ligating left lung of rat, connecting 1ml syringe via trachea cannula, pouring physiological saline 1ml each time, recovering physiological saline, collecting, repeating pouring and extracting for 3 times, and detecting total white blood cell, neutrophil ratio, eosinophil ratio, lymphocyte ratio, etc. of alveolar lavage liquid by automatic cell biochemical detector.

(3) Alveolar lavage fluid cytokine and neuropeptide expression assays

After the last administration is finished for cough detection, each group of rats is deeply anesthetized, alveolar lavage fluid is obtained, lavage fluid is stored at the temperature of minus 80 ℃, and then an ELISA kit method is adopted to detect the expression quantity of cytokines (IL-4, IFN-gamma, TNF-alpha) and neuropeptides (SP, NKA, CGRP) in the alveolar lavage fluid.

(4) Lung tissue pathology

After bronchoalveolar lavage is completed, a ligature is cut off, each group of rat lung tissues are rapidly taken down, the weight of the organ coefficients is calculated, then the upper right leaf lung tissues are taken for trimming, the lung tissue blocks with moderate size at the same part are uniformly taken, the tissue blocks are fixed overnight by 10% paraformaldehyde, the normal paraffin embedding section is used for H & E staining, and the morphological structure and inflammatory cell infiltration condition of the lung and the trachea are observed under a light microscope.

The statistical method comprises the following steps: statistical analysis was performed using SPSS21.0 for windows statistical software. Measurement data, one-way-classification ANOVA, one-way analysis of variance using one-way classification of one-way analysis of variance, were compared two by two using t-test. With P<0.05 was used as a criterion with statistical differences. The counting data is expressed by the rate and the composition ratio, and x is adopted ² And (5) checking. With P<0.05 was used as a criterion with statistical differences.

Experimental results: as shown in Table 1, after 7 days of continuous administration, capsaicin solution stimulated cough in rats, and the Chinese medicinal composition significantly reduced the number of cough times (P < 0.01) compared with the model group.

As shown in table 2: alveolar lavage fluid was collected for cytological examination 20 days after molding of cough model rats after infection. Compared with the normal group of rats, the white blood cell count (WBC) (P < 0.01), the neutrophil count (NEUT) (P < 0.01), the lymphocyte count (LYMPH) (P < 0.01) and the monocyte count (MONO) (P < 0.05) of the model group of rats are all significantly increased. At the same time, the proportion of lymphocytes (LYMPH%) in the alveolar lavage fluid of the model group of rats is significantly reduced (P < 0.05). After 7 days of administration of the Chinese medicinal composition, the Chinese medicinal composition significantly down-regulates the white blood cell count (WBC) (P < 0.05), the neutrophil count (NEUT) (P < 0.05) and the lymphocyte count (LYMPH) (P < 0.05) in alveolar lavage fluid compared with the model group.

As shown in table 3: compared with the normal group of rats, the inflammatory factors IFN-gamma (P < 0.05) in the alveolar lavage fluid of the model group of rats are obviously reduced, IL-4 (P < 0.001) and TNF-alpha (P < 0.01) are obviously increased; cough-related factors SP (P < 0.01), CGRP1 (P < 0.05) and NKA (P < 0.01) were all significantly elevated. The traditional Chinese medicine composition is administered for 7 days for treatment, the level of inflammatory factor IL-4 in the alveolar lavage fluid of a rat with a cough model after infection is obviously reduced (P is less than 0.01), and the level of IFN-gamma is obviously increased (P is less than 0.05); cough related factors CGRP1 (P < 0.05) and SP levels (P < 0.01) were significantly reduced.

Animals in the pathological tissue examination model group were slightly to slightly small bronchiole mucosa epithelial cell degeneration/necrosis (12/12), slightly to slightly interstitial mononuclear cell infiltration (12/12), slightly to moderately alveolar macrophage aggregation (12/12) compared with the normal group, and although individual animals in the normal group also had the above-mentioned lesions, the pathological changes of the model animals were numerous in number and the degree of the lesions was heavy, and the changes were considered to be related to modeling. Compared with the model group, the traditional Chinese medicine composition group has the advantages that the degeneration/necrosis of lung small bronchus mucosa epithelial cells and the infiltration of interstitial mononuclear cells into each group of lesions are equivalent in number, but the aggregation of lung alveolus macrophages of rats in the traditional Chinese medicine composition group is reduced.

The test results show that under the test conditions, the traditional Chinese medicine composition has an antitussive effect on SD rats with cough after infection.

TABLE 1 cough latency and cough count results

Note that: the model set is compared to the normal set, ^* p is less than 0.05; ^** p <0.01.

The drug administration set is compared with the model set, ^# p is less than 0.05; ^## p <0.01.

TABLE 2 alveolar lavage cytology assay

Note that: model group compared to normal group, representing P < 0.05; * Represents P <0.01.

Drug administration group was compared with model group, # represents P < 0.05.

TABLE 3 detection of inflammatory factors and cough factors in lung lavage fluid

Drug administration group was compared with model group, # represents P < 0.05; # denotes P <0.01.

Comparative study of the Chinese medicinal composition of example seven and literature formula

Experimental animals: SPF-grade guinea pig

Experimental drugs: the Chinese medicinal composition is prepared according to the third embodiment

The literature formula is as follows: radix Platycodi, herba Ephedrae, radix Asteris, radix Stemonae, rhizoma Cynanchi Stauntonii, semen Armeniacae amarum, herba Ardisiae Japonicae, herba Houttuyniae, and folium Eriobotryae. Prepared according to the method disclosed in the literature (a pharmaceutical composition for treating cough and asthma, a preparation method and application thereof-201710486890.5).

The experimental method comprises the following steps: after the animal adaptability observation is finished, the guinea pigs are randomly divided into a normal group, a model group, a traditional Chinese medicine composition group and a literature formula group. The model group, the traditional Chinese medicine composition group and the literature group test guinea pigs all manufacture cough models after infection through aerosol inhalation of citric acid. The molding mode is as follows: placing guinea pigs into a systemic atomization exposure system, spraying 17.5% citric acid solution at a speed of 5L/min, and spraying for 6min. The corresponding medicines are respectively administered by gastric lavage to the guinea pigs of the traditional Chinese medicine composition group and the literature formula group, distilled water is administered to the normal group and the model group, and the administration is carried out for 7d continuously once daily. 1h after the last administration, the model group, the traditional Chinese medicine composition group and the literature group guinea pigs are placed into a systemic atomization exposure system, 17.5% citric acid solution is sprayed at a speed of 5L/min, spraying is carried out for 6min, and the incubation period of the cough of the guinea pigs and the cough times in 6min are observed and recorded.

The statistical method comprises the following steps: statistical Using SPSS21.0 for windows statistical softwareAnd (5) analyzing. The counting data is expressed by the rate and the composition ratio, and x is adopted ² And (5) checking. With P<0.05 was used as a criterion with statistical differences.

Experimental results: as shown in Table 4, after 7 days of continuous administration, the Chinese medicinal composition and the literature formulation each significantly reduced the number of coughs and prolonged the cough latency, compared with the model group, and had a statistical difference (P < 0.01). The cough inhibition rate of the traditional Chinese medicine composition and the literature formula reaches more than 50%, but compared with the literature formula, the traditional Chinese medicine composition has more remarkable effects of reducing the times of cough and prolonging the incubation period of the cough, and the cough inhibition rate is higher, so that the treatment effect of the traditional Chinese medicine composition is superior to that of the literature formula.

Table 4 results of guinea pig cough latency and cough count within 6min

Drug administration group was compared with model group, " ^#" Represents P<0.05，" ^##" Representing P<0.01。

Example eight comparative study of Chinese medicinal composition and Xuefang

Experimental animals: SPF-grade Hartley guinea pig

Medicine composition of formula 1: 6g of poria cocos, 9g of loquat leaves, 9g of aster, 15g of Japanese ardisia herb, 9g of burdock, 6g of ephedra, 6g of white paeony root and 3g of liquorice.

Medicine composition of formula 2: 9g of radix stemonae, 9g of loquat leaves, 9g of aster, 15g of Japanese ardisia herb, 9g of burdock, 6g of ephedra, 6g of white paeony root and 3g of liquorice.

The medicine composition of the prescription 3 comprises the following components: 9g of radix stemonae, 6g of tuckahoe, 9g of aster, 15g of Japanese ardisia herb, 9g of burdock, 6g of ephedra, 6g of white peony root and 3g of liquorice.

Medicine composition of formula 4: 9g of radix stemonae, 6g of poria cocos, 9g of loquat leaves, 15g of Japanese ardisia herb, 9g of burdock, 6g of ephedra, 6g of white paeony root and 3g of liquorice.

The medicine composition of the prescription 5 comprises the following components: 9g of radix stemonae, 6g of poria cocos, 9g of folium eriobotryae, 9g of aster, 9g of burdock, 6g of ephedra, 6g of radix paeoniae alba and 3g of liquorice.

The medicine composition of the prescription 6 comprises the following components: 9g of radix stemonae, 6g of poria cocos, 9g of folium eriobotryae, 9g of aster, 15g of Japanese ardisia herb, 6g of ephedra herb, 6g of white peony root and 3g of liquorice.

Medicine composition of formula 7: 9g of radix stemonae, 6g of poria cocos, 9g of folium eriobotryae, 9g of aster, 15g of Japanese ardisia herb, 9g of burdock, 6g of white peony root and 3g of liquorice.

Medicine composition of formula 8: 9g of radix stemonae, 6g of poria cocos, 9g of folium eriobotryae, 9g of aster, 15g of Japanese ardisia herb, 9g of burdock, 6g of ephedra herb and 3g of liquorice.

The medicine composition of the prescription 9 comprises the following components: 9g of radix stemonae, 6g of poria cocos, 9g of folium eriobotryae, 9g of aster, 15g of Japanese ardisia herb, 9g of burdock, 6g of ephedra herb and 6g of white paeony root.

The preparation method of the medicine comprises the following steps: prepared according to the method of example one.

The experimental method comprises the following steps: after the animal adaptability observation is completed, the guinea pigs are randomly divided into a normal group, a model group, a traditional Chinese medicine composition group and various disassembly groups (disassembly 1, disassembly 2, disassembly 3, disassembly 4, disassembly 5, disassembly 6, disassembly 7, disassembly 8 and disassembly 9). The model group, the traditional Chinese medicine composition group and the guinea pigs of each prescription are subjected to nasal drop lipopolysaccharide, smoking and capsaicin atomization excitation to construct a cough guinea pig model after infection. The animals are placed in a whole body exposure atomization system and ventilated at a certain air flow speed, a metal smoking box (sawdust cigarette) is placed in an exposure box to be smoked, smoking is carried out for 30min each day, smoking is carried out for 1 time/d, 10d is continuous, drinking water is taken freely, and normal groups are ventilated only and smoking stimulation is not carried out. After the end of smoking, rats were weighed, and after the rest of guinea pigs were shallow, except normal group of guinea pigs, at 11, 14 and 17 days, 0.4mg/ml Lipopolysaccharide (LPS) solution was added dropwise via nose, and the addition volume was 10. Mu.l/10 g, and normal group was replaced with normal saline. On days 12, 13, 15, 16, 18, guinea pigs were placed in a cough and asthma inducing machine at 1X 10 ^-4 The mol/L capsaicin solution is atomized and inhaled for excitation for 3min. The Chinese medicinal composition and guinea pigs of each prescription are respectively administered with corresponding medicines by gastric lavage, distilled water is administered in normal group and model group, each timeThe administration was continued for 7d 1 time a day. After the last administration for 24 hours, the guinea pigs are put into a closed bell jar of a multifunctional cough and asthma inducing instrument, atomized and inhaled for 3 minutes by using capsaicin solution, and the time of occurrence of cough and the times of cough in 8 minutes (including the times of manually recorded cough in 3 minutes of atomized and inhaled) are recorded from the first loud cough judged by the instrument

The statistical method comprises the following steps: statistical analysis was performed using SPSS21.0 for windows statistical software. The counting data is expressed by the rate and the composition ratio, and x is adopted ² And (5) checking. With P<0.05 was used as a criterion with statistical differences. Experimental results: as shown in Table 5, the Chinese medicinal composition and each prescription significantly reduced the number of coughs and prolonged the incubation period compared to the model group, and had a statistical difference (P < 0.01). However, the therapeutic effect of each prescription of any least one medicine is not as good as that of the traditional Chinese medicine composition, and the medicines have statistical differences (P is less than 0.01).

Table 5 results of guinea pig cough latency and cough count within 8min

Note that: model group is compared with normal group, " ^#" Represents P<0.05，" ^##" Representing P<0.01。

Each dosing group was compared to the model group, "×" indicated P <0.05, "×" indicated P <0.01.

Example nine clinical comparative study of Chinese medicinal composition and Dioxypropylamine hydrochloride tablet

1. Clinical data and method

1.1 study object

All post-infection cough patients who were diagnosed at the clinic of the affiliated hospital of Shandong traditional Chinese medicine university (Shandong province middle hospital).

1.2 diagnostic criteria

1.2.1 Western diagnostic criteria

Referring to the diagnosis and treatment guidelines for cough (2021 edition), the most common etiology is selected: (1) cough secondary to a previous respiratory tract infection; (2) After the symptoms of the respiratory tract infection in the acute stage disappear, the cough still persists for 3 to 8 weeks; (3) The dry cough or cough with little white mucus phlegm is stimulated, which usually lasts for 3-8 weeks, and X-ray chest radiography examination has no abnormality; (4) normal person for lung function examination; (5) excluding cough caused by other causes.

1.2.2 criteria for diagnosis of waiting for Chinese medical Condition

The diagnosis standard of cough after pathogenic wind lung infection is formulated by referring to the traditional Chinese medicine part related to cough mentioned in the diagnosis and treatment guidelines of cough of the internal medicine disease diagnosis curative effect standard of traditional Chinese medicine and 2021 edition: main symptoms are as follows: cough with itching throat, dry cough or little phlegm, and unsmooth expectoration. And the combined symptoms are as follows: (1) no obvious cold or heat in the body; (2) is often induced by cold and hot air, peculiar smell and laughter; (3) exogenous factors often induce cough exacerbation or recurrence. Tongue pulse: a pale red tongue with thin and white coating. Pulse: the pulse is wiry or slippery. The above main syndrome + concurrent syndrome 1 and the above can be diagnosed by referring to the tongue pulse.

1.2.3 inclusion criteria: (1) ages 18-65 (excluding 18, 65 years); (2) meets post-infection cough diagnostic criteria; (3) cough onset time is more than or equal to 3 weeks and less than or equal to 8 weeks; (4) Meets the traditional Chinese medicine diagnosis and differentiation standard of cough-wind evil lung syndrome; (5) cough VAS score is more than or equal to 60mm (scale of 0-100 mm); (6) subject informed consent and signed informed consent.

1.2.4 exclusion criteria: (1) Cough patients with Cough Variant Asthma (CVA), upper Airway Cough Syndrome (UACS), eosinophilic Bronchitis (EB), gastroesophageal reflux cough (GERC), chronic bronchitis and other etiologies; (2) the body temperature (armpit) is more than or equal to 37.3 ℃; (3) Chest film prompts abnormal patients such as pulmonary infection, tuberculosis, tumor, hydrothorax and the like; (4) Patients with other respiratory diseases such as pneumonia, bronchial asthma, bronchiolitis, bronchopneumonia, and respiratory allergy; (5) FeNO > 30 ppb; (6) Patients suffering from nasal diseases such as rhinitis, sinusitis symptoms or post-nasal drip; (7) Patients with drug induced cough by ACEI and ARB antihypertensive drugs, beta-receptor blocker drugs, mycophenolate mofetil, nitrofurantoin, propofol, leflunomide, simvastatin, gamma-interferon, omeprazole and other drugs; (8) Suffering from the cardiovascular systemResearchers with severe basic diseases such as diseases, kidney diseases, liver diseases, blood system diseases, nervous system diseases, neuromuscular diseases, metabolic and endocrine system diseases, immune function inhibition (including immunosuppressant application or immune function deterioration caused by HIV infection) and the like determine that the researchers cannot enter the group; (9) Clinical examination index (BUN, cr, ALT etc.) exceeds 1.5 times of the upper limit of normal reference value or blood routine examination white blood cell > 12×10 ⁹ L; blood creatinine>Normal reference upper limit; urinary protein > +; blood white cell < 3.0X10 ⁹ L or > 10.0X10 ⁹ L; and/or neutrophil (N) classification>80%; (10) those severely suffering from multiple organ failure; (11) pregnant, ready-to-gestate or lactating women; (12) unable to collaborate, e.g., suffering from mental illness; (13) to test those who are involved in drug allergy; (14) Other drug clinical trials or other study takers were enrolled in the last three months.

1.2.5 estimation of sample size

Reference is made to the relevant formula calculations from medical statistics, 6 th edition. From the aspect of effectiveness, according to the statistical requirements, an effectiveness test, a double-side test, alpha=0.05, beta=0.2, the expected average effective rate is 0.90, the number of the cases is 126, and the number of the cases is determined to be 140 by considering the shedding factors, wherein the number of the cases is 70 in the current test.

1.2.6 ethical examination

The study has been reviewed by the ethical committee of the Shandong university of traditional Chinese medicine affiliated hospital (Shandong province middle hospital) and obtained with ethical number ChiCTR220035.

1.3 pharmaceutical treatment western medicine group: dioxypropion hydrochloride tablets are administered for treatment, with a specification of 5mg x 100 tablets. Orally taken by an adult once for 5mg and 3 times a day.

The traditional Chinese medicine group: the traditional Chinese medicine composition provided by the application is administered with boiled water. 1 bag at a time, 3 times a day, and half an hour after meal.

The Chinese medicinal composition is prepared according to the dosage of the third implementation, and is produced by Suzhou Wu Songjiang pharmaceutical Co. Adding 10 times of water into all the medicinal materials, decocting for 1.5 hours twice, filtering decoction, and concentrating filtrate under reduced pressure to obtain fluid extract; centrifuging, concentrating the supernatant under reduced pressure to obtain extract with relative density of 1.20-1.30, drying, adding adjuvant, and granulating. The granule is taken with boiled water 1 bag at a time, 3 times a day, and half an hour after meal.

Both groups were treated for 14 days.

1.4 observations index

Each group of patients was scored for cough level before and after treatment, respectively. Scoring methods were recommended using the guidelines for diagnosis and treatment of cough (2021 edition), and a table of simple cough scores (cough evaluation test, CET). The efficacy evaluation was evaluated on the basis of efficacy index = (total integral before treatment-total integral after treatment)/(total integral before treatment). (1) The effect is shown: the symptoms are obviously improved, and the symptom score is reduced by more than or equal to 70 percent compared with the symptom score before treatment; (2) the method is effective: the symptoms are improved, and the symptom score is reduced by more than or equal to 30 percent and less than 70 percent compared with the symptom score before treatment; (3) invalidation: symptoms are not improved, and symptoms integral is reduced by less than 30% compared with that before treatment; (4) weighting: the symptoms are aggravated, and the integral of symptoms is reduced by less than 0 percent. Statistical methods: statistical analysis was performed using SPSS21.0 for windows statistical software. The counting data is expressed by the rate and the composition ratio, and x is adopted ² And (5) checking. With P<0.05 was used as a criterion with statistical differences.

2. Results

As shown in Table 6, 140 cough cases after infection are collected together, and 70 Chinese medicine groups and western medicine groups are respectively used, wherein the total effective rate of the Chinese medicine groups is 94.29%, and compared with the western medicine groups, the effective rate of the Chinese medicine groups is obviously improved, and the statistical difference (P is less than 0.05) is generated.

Table 6 comparison/examples of clinical efficacy of two groups

The various aspects of the application have been described above. It will be understood, however, that equivalent changes and modifications may be made thereto by those skilled in the art without departing from the spirit of the application, which changes and modifications likewise fall within the scope of the appended claims.

Claims

1. The traditional Chinese medicine composition for treating post-infection cough is characterized by being prepared from the following raw materials in parts by weight: 5-10 parts of radix stemonae, 3-9 parts of poria cocos, 5-10 parts of folium eriobotryae, 5-10 parts of aster, 10-18 parts of Japanese ardisia herb, 5-10 parts of burdock, 3-9 parts of ephedra, 3-9 parts of white paeony root and 1-5 parts of liquorice.

2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 7-9 parts of radix stemonae, 4-7 parts of poria cocos, 7-9 parts of folium eriobotryae, 6-9 parts of aster, 13-17 parts of Japanese ardisia herb, 7-9 parts of burdock, 5-7 parts of ephedra, 5-7 parts of white paeony root and 2-4 parts of liquorice.

3. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5 parts of radix stemonae, 9 parts of poria cocos, 10 parts of loquat leaves, 6 parts of aster, 10 parts of Japanese ardisia herb, 5 parts of burdock, 9 parts of ephedra herb, 3 parts of white paeony root and 2 parts of liquorice.

4. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 parts of radix stemonae, 7 parts of poria cocos, 7 parts of folium eriobotryae, 5 parts of aster, 13 parts of Japanese ardisia herb, 8 parts of burdock, 7 parts of ephedra herb, 5 parts of white paeony root and 5 parts of liquorice.

5. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 9 parts of radix stemonae, 6 parts of poria cocos, 9 parts of folium eriobotryae, 9 parts of aster, 15 parts of Japanese ardisia herb, 9 parts of burdock, 6 parts of ephedra herb, 6 parts of white paeony root and 3 parts of liquorice.

6. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 7 parts of radix stemonae, 4 parts of poria cocos, 8 parts of folium eriobotryae, 10 parts of aster, 18 parts of Japanese ardisia herb, 10 parts of burdock, 5 parts of ephedra herb, 7 parts of white paeony root and 1 part of liquorice.

7. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 8 parts of radix stemonae, 3 parts of poria cocos, 5 parts of loquat leaves, 7 parts of aster, 17 parts of Japanese ardisia herb, 7 parts of burdock, 3 parts of ephedra herb, 9 parts of white paeony root and 4 parts of liquorice.

8. A Chinese medicinal compound preparation for treating cough after infection is characterized in that the Chinese medicinal compound preparation is decoction, granules, powder, capsules, tablets or oral liquid taking the Chinese medicinal composition as an active ingredient in claim 1 or 2 or 3 or 4 or 5 or 6.

9. The compound traditional Chinese medicine preparation according to claim 8, wherein the compound traditional Chinese medicine preparation is a granule.

10. The use of a Chinese medicinal composition as claimed in claim 1 or 2 or 3 or 4 or 5 or 6 or 7 in the manufacture of a medicament for the treatment of post-infection cough.