CN109260340B

CN109260340B - Traditional Chinese medicine composition and preparation method and application thereof

Info

Publication number: CN109260340B
Application number: CN201811222662.8A
Authority: CN
Inventors: 肖伟; 王永香; 孙晓萍; 贾银芝; 王伟; 周恩丽; 王星星; 吴云; 王振中
Original assignee: Jiangsu Kanion Pharmaceutical Co Ltd
Current assignee: Jiangsu Kanion Pharmaceutical Co Ltd
Priority date: 2018-10-19
Filing date: 2018-10-19
Publication date: 2024-01-19
Anticipated expiration: 2038-10-19
Also published as: CN117797221A; CN109260340A

Abstract

The invention provides a traditional Chinese medicine composition, which is characterized by comprising the following components: 0.5 to 1 part of ephedra herb, 0.5 to 1.5 parts of bitter apricot seed, 0.5 to 1 part of perilla seed, 1.5 to 3 parts of white mulberry root-bark, 1.5 to 2 parts of baikal skullcap root, 0.5 to 1.5 parts of cicada slough, 0.5 to 1.5 parts of stiff silkworm, 1.5 to 3 parts of earthworm, 0.5 to 1.5 parts of peucedanum root, 0.5 to 1.5 parts of blackberry lily, 1.5 to 3 parts of coltsfoot flower, 0.5 to 1.5 parts of rhizoma pinellinae praeparata and 0.5 to 1 part of liquorice. The invention provides a traditional Chinese medicine composition, which has the effects of freeing lung, relieving asthma, relieving cough, clearing heat and reducing phlegm. Modern pharmacological experiments show that the composition can be used for treating bronchial asthma or chronic persistent asthma, bronchitis accompanied with cough and pharyngitis.

Description

Traditional Chinese medicine composition and preparation method and application thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition, and a preparation method and application thereof.

Background

Bronchial asthma (abbreviated asthma) is a chronic inflammatory disease of the airways involving various cells (eosinophils, mast cells, T cells, neutrophils, airway epithelial cells, etc.) and cellular components. Asthma is often manifested as narcolepsy, chest distress, and dyspnea. Mainly caused by chronic inflammation and associated increased airway hyperresponsiveness, leading to recurrent episodes of wheezing, dyspnea, chest distress and cough, especially during the night and early morning hours. Some patients expectorate more than the onset tends to relieve, if there is no combined infection, it is often sticky white sputum, and it is tough, sometimes in the form of rice grains or mucous columns. The severity and duration of the onset varies widely from individual to individual, with the light individual having chest tightness only for several minutes, the symptoms usually being episodic, most patients being self-relieving or therapeutic relieving, and the heavy individual being extremely dyspnea for several weeks or more. Patients with asthma may be fatal if they have severe acute attacks and are not cured in time.

The traditional Chinese medicine considers that asthma belongs to the categories of 'asthma syndrome', 'asthma disease' and the like in traditional Chinese medicine. The symptoms are caused by the incorrect treatment of the disease caused by the pathogenic factors, the pathogenic factors remain in the lung collaterals, and the pathogenic factors are transformed into fire, the body fluid is burned into phlegm, and the phlegm-heat stagnates in the lung. The lung qi failing to disperse for a long time affects qi and blood circulation, and stagnant blood stays and is a mutual attack with phlegm-fluid, so that internal retention of phlegm-heat and stagnant blood are the basic pathological changes of asthma, and extend through the period of asthma attack and remission. And invasion of exogenous evil, improper diet, overstrain and internal injury of emotion, excessive wind with sudden spasm, excessive breathing and wheezing in the throat.

The treatment of airway inflammation with the assistance of bronchodilators is currently the best solution for modern medical treatment. The clinical application is mainly the use of glucocorticoids and β2 receptor agonists. However, hormone therapy can only temporarily suppress airway inflammation and reduce airway responsiveness for up to 3 years, and it is difficult to completely reduce airway responsiveness to normal, asthma cannot be cured, and various side effects such as substance metabolism imbalance can be caused. While β2 receptor agonists may exhibit rapid desensitization, reduced pulmonary function, abnormal bronchospasm, increased airway responsiveness, and other adverse consequences in asthmatic patients during use. The traditional Chinese medicine can trace back to the war period of spring and autumn for the treatment of asthma, and the theory of between prime and yin and yang has the symptoms of ' yin struggling in the interior and yang struggling in the exterior ', soul sweat is not hidden, four adverse reactions are generated, lung fumigating is generated, people wheeze ' is recorded, and abundant experience is accumulated for the treatment of the asthma. Along with the continuous progress of clinical practice, the traditional Chinese medicine shows unique curative effect and obvious advantages in the treatment of bronchial asthma. According to the pathogenesis and clinical manifestations of asthma, the treatment methods are also different, and methods such as internal treatment, acupuncture, traditional Chinese medicine atomization therapy, traditional Chinese medicine enema therapy, diet therapy and the like can be adopted, but no exact and effective traditional Chinese medicine prescription is known at present.

Acute pharyngitis is acute inflammation of pharyngeal mucosa, submucosa and lymphoid tissues, and its pathogenic factors are mainly bacterial infection, viral infection, physicochemical irritation, etc. Is a common frequently encountered disease in clinic, and is also a local manifestation of systemic diseases or a precursor manifestation of acute infectious diseases. In recent years, the incidence of acute pharyngitis has been dramatically increased by environmental climate factors. The acute pharyngitis belongs to the category of throat arthralgia in the traditional Chinese medicine, and the incidence rate of the acute pharyngitis accounts for 7-17% of the throat diseases. If the effective treatment is not available, the repeated attacks of acute pharyngitis are often changed into chronic, so that the treatment becomes difficult. At present, no obvious medicine is available for treating acute pharyngitis.

Disclosure of Invention

In order to solve the technical problems, the invention provides a traditional Chinese medicine composition, which is characterized by comprising the following components in parts by weight: 0.5 to 1 part of ephedra herb, 0.5 to 1.5 parts of bitter apricot seed, 0.5 to 1 part of perilla seed, 1.5 to 3 parts of white mulberry root-bark, 1.5 to 2 parts of baikal skullcap root, 0.5 to 1.5 parts of cicada slough, 0.5 to 1.5 parts of stiff silkworm, 1.5 to 3 parts of earthworm, 0.5 to 1.5 parts of peucedanum root, 0.5 to 1.5 parts of blackberry lily, 1.5 to 3 parts of coltsfoot flower, 0.5 to 1.5 parts of rhizoma pinellinae praeparata and 0.5 to 1 part of liquorice. The use may be in any manner that is beneficial for improving the patient's corresponding symptoms, including treatment or prevention.

Further, the traditional Chinese medicine composition comprises: 0.6 to 0.7 part of ephedra herb, 0.9 to 1.1 part of bitter apricot seed, 0.6 to 0.7 part of perilla seed, 1.8 to 2.2 parts of white mulberry root-bark, 1.5 to 1.7 parts of baikal skullcap root, 0.9 to 1.1 parts of cicada slough, 0.9 to 1.1 parts of stiff silkworm, 1.8 to 2.2 parts of earthworm, 0.9 to 1.1 parts of peucedanum root, 0.9 to 1.1 parts of blackberry lily, 1.8 to 2.2 parts of coltsfoot flower, 0.9 to 1.1 parts of rhizoma pinellinae praeparata and 0.6 to 0.7 part of liquorice.

Preferably, the Chinese medicinal composition comprises: 0.61 part of ephedra herb, 1 part of bitter apricot seed, 0.61 part of perilla fruit, 2 parts of white mulberry root-bark, 1.6 parts of baical skullcap root, 1 part of cicada slough, 1 part of stiff silkworm, 2 parts of earthworm, 1 part of peucedanum root, 1 part of blackberry lily, 2 parts of coltsfoot flower, 1 part of rhizoma pinellinae praeparata and 0.61 part of liquoric root.

The composition can be directly ground into powder from raw materials, or can be an extract or other forms prepared by conventional means.

The invention also provides a preparation method of any one of the traditional Chinese medicine composition, which is characterized by comprising the following steps:

decocting herba Ephedrae, semen Armeniacae amarum, fructus Perillae, rhizoma Pinelliae Preparata, and Glycyrrhrizae radix in water, filtering, concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.05-1.10 (60deg.C), cooling to room temperature, adding ethanol into the concentrate to ethanol content of 50-80%, standing for more than 24 hr, collecting supernatant, concentrating under reduced pressure until no ethanol smell is present to obtain extract 1;

reflux-extracting five medicinal materials of radix scutellariae, radix peucedani, blackberry lily, flos farfarae and cortex mori radicis with 60-80% ethanol, filtering, and concentrating the filtrate under reduced pressure to obtain extract 2;

decocting periostracum Cicadae, bombyx Batryticatus and Lumbricus with water, filtering, and concentrating the filtrate under reduced pressure to obtain extract 3;

mixing extract 1, extract 2 and extract 3, concentrating under reduced pressure to obtain wet extract with relative density of 1.10-1.25 (60 deg.C), and drying under reduced pressure.

Specifically, the preparation method comprises the following steps:

decocting herba Ephedrae, semen Armeniacae amarum, fructus Perillae, rhizoma Pinelliae Preparata, and Glycyrrhrizae radix with 6-12 times of water for 1-3 times, each time for 1-3 hr, filtering, concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.05-1.10 (60deg.C), cooling to room temperature, adding ethanol to ethanol content of 70-80%, standing for more than 24 hr, collecting supernatant, concentrating under reduced pressure to obtain extract 1 without alcohol taste;

reflux extracting radix Scutellariae, radix Peucedani, rhizoma Belamcandae, flos Farfarae and cortex Mori with 6-12 times of 60-80% ethanol for 1-3 times each for 0.5-3 hr, filtering, concentrating the filtrate under reduced pressure to obtain extract 2;

decocting periostracum Cicadae, bombyx Batryticatus and Lumbricus with 6-12 times of water for 1-3 times (each for 1-3 hr), filtering, and concentrating the filtrate under reduced pressure to obtain extract 3 with relative density of 1.05-1.10 (60deg.C);

mixing extract 1, extract 2 and extract 3, concentrating under reduced pressure to obtain wet extract with relative density of 1.23-1.25 (60deg.C), and drying under reduced pressure.

Preferably, the preparation method comprises the following steps:

decocting herba Ephedrae, semen Armeniacae amarum, fructus Perillae, rhizoma Pinelliae Preparata, and Glycyrrhrizae radix with 10 times of water for 2 times, each time for 1.5 hr, filtering, concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.05-1.10 (60deg.C), cooling to room temperature, adding ethanol to alcohol content of 75%, standing for more than 24 hr, collecting supernatant, concentrating under reduced pressure until no alcohol smell is present to obtain extract 1; reflux extracting Scutellariae radix, radix Peucedani, rhizoma Belamcandae, flos Farfarae, and cortex Mori with 8 times of 70% ethanol for 2 times each for 1.0 hr, filtering, concentrating the filtrate under reduced pressure until no alcohol smell exists to obtain extract 2; decocting periostracum Cicadae, bombyx Batryticatus and Lumbricus with 8 times of water for 2 times (each time for 1.5 hr), filtering, and concentrating the filtrate under reduced pressure to obtain extract 3 with relative density of 1.08-1.10 (60deg.C); combining extract 1, extract 2 and extract 3, concentrating under reduced pressure to obtain wet extract with relative density of 1.23-1.25 (60deg.C), and drying under reduced pressure (70deg.C).

The invention also provides a traditional Chinese medicine composition prepared by any one of the preparation methods.

The invention also provides application of any one of the traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by any one of the preparation methods in preparation of medicines for treating asthma, pharyngitis or cough. Wherein the pharyngitis or cough can be pharyngitis or cough caused by asthma and bronchitis.

The traditional Chinese medicine composition can be used for preparing medicines for freeing lung, relieving asthma, clearing heat and resolving phlegm or chronic duration of bronchial asthma.

The invention also provides a medicine which is characterized by comprising any one of the traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by any one of the preparation methods and pharmaceutically acceptable auxiliary materials or additives.

Further, the medicament is selected from the group consisting of tablets, capsules, granules, pills, injections, soft extracts, suspensions, dispersions, syrups, suppositories, gels, aerosols, patches and oral liquids.

In the traditional Chinese medicine composition disclosed by the invention:

the ephedra herb, which is pungent and dispersed and slightly bitter in property, enters lung and bladder meridians, and can open the stasis of fur to smooth lung qi; for the interior descending and ascending of qi, it is an essential herb for cough and dyspnea due to lung qi obstruction, because it is good at relieving cough and dyspnea due to lung qi obstruction. Bitter apricot kernel has the effects of relieving cough, moistening lung, relieving asthma, promoting the production of body fluid, stimulating appetite, and treating cough and asthma due to consumptive disease and constipation due to intestinal dryness; perilla seed has effects of lowering qi, relieving asthma, eliminating phlegm and relieving cough; herba Ephedrae with effect of clearing lung-heat and relieving asthma. Radix Scutellariae, rhizoma Belamcandae, cortex Mori, rhizoma Pinelliae Preparata, flos Farfarae, radix Peucedani, periostracum Cicadae, lumbricus, and Bombyx Batryticatus. Baical skullcap root, radix Scutellariae has the effects of clearing heat and drying dampness, purging pathogenic fire and removing toxin, and "Ben Cao Jing Shu" describes: bai Huang is good at clearing and descending, so it eliminates pathogenic factors and bitter in taste and eliminates dampness; cold in yin can dispel heat, so it governs heat. Blackberry lily has the effects of clearing heat and detoxicating, dissolving phlegm and relieving sore throat; can clear heat and reduce toxin, dispel hematoma, relieve sore throat, clear lung and dissipate nodulation, and is an essential drug for treating sore throat, excessive phlegm, asthma and cough; it is combined with Huang Qin to dispel lung fire, unblock throat and treat lung abscess, throat dysphoria and hoarseness. The mulberry bark is used for purging lung, relieving asthma, inducing diuresis to alleviate edema, treating cough and asthma due to lung heat, edema of face and eyes, difficult urination and the like. The rhizoma pinellinae praeparata is mainly used for treating cough and asthma with excessive phlegm, phlegm-fluid palpitation, dizziness with wind-phlegm, phlegm syncope and headache, etc. Tussilago farfara, pungent, sweet and warm in nature, enters lung meridian and is indicated for lung Jiao Sheju with blood in phlegm and chronic cough, consumptive lung, dyspnea with phlegm and diabetes, so that lung orifices are cool and refreshing. Before Hu Xinsan, it is indicated for cough and dyspnea due to wind-heat stagnation in lung because it is bitter to reduce and dispel wind-heat, xin Kexuan, it is good at treating cough and dyspnea due to wind-heat stagnation in lung, and it is combined with bitter apricot kernel to disperse lung qi downward and relieve cough and dyspnea because of its action of dispelling wind-heat. The periostracum cicadae is slightly floating, enters lung and liver channels, and is combined with ephedra and earthworm to strengthen the evacuation of internal wind; the stiff silkworm has the effects of calming endogenous wind and relieving spasm, dispelling wind-heat, resolving phlegm and resolving masses, and dispelling wind and resolving phlegm are taken as the winner; it is combined with Di Long to stop wind and spasm and has stronger actions of activating collaterals and relieving pain. Licorice root, radix Glycyrrhizae Praeparata has the effects of invigorating spleen and replenishing qi, relieving cough and moistening lung, relieving urgency and detoxifying, and harmonizing hundred medicines, ben Cao Tong Xuan (materia Medica of the same general formula): entering spleen and stomach; the miscellaneous records: warming middle-jiao and descending qi, relieving restlessness and shortness of breath, injuring viscera and relieving cough, quenching thirst, dredging channels and collaterals, li Xieqi and relieving hundred drug toxins.

The prescription has the main functions of: the composition has effects of dispersing lung qi, relieving asthma, clearing heat, and eliminating phlegm, and can be used for treating chronic duration of bronchial asthma, cough due to bronchitis, and pharyngitis.

Compared with the prior art, the invention has the beneficial effects that:

1. the Chinese medicinal composition for treating bronchial asthma or chronic persistent asthma, bronchitis accompanied with cough and pharyngitis provided by the invention has the effects of freeing lung, relieving asthma, relieving cough, clearing heat and reducing phlegm. Animal experiment results show that the composition has the effects of remarkably improving acute asthma symptoms and airway inflammatory reactions, remarkably reducing the generation and release of anaphylactic substance IgE, reducing the local lung tissue infiltration of eosinophils, and remarkably resisting allergy; the traditional Chinese medicine composition has the effects of remarkably improving chronic asthma symptoms and airway inflammatory response, remarkably reducing the generation and release of anaphylactic substance IgE, reducing the local lung tissue infiltration of eosinophils, remarkably resisting allergy, and being applicable to the treatment of chronic asthma and variant cough; has the effects of remarkably improving acute pharyngitis symptoms and relieving inflammatory reaction, and can be used for treating pharyngitis, such as pharyngeal congestion and swelling. And the curative effect of the composition in treating asthma, cough and pharyngitis is better than that of the traditional Chinese medicine composition in comparative example.

2. The invention also provides a preparation method of the traditional Chinese medicine composition with better effect, namely, according to the basic property of the medicinal effect substances of the medicines, five medicinal materials of ephedra, bitter apricot kernel, perilla fruit, rhizoma pinellinae praeparata and liquorice are extracted by water and subjected to alcohol precipitation to obtain effective parts, and ineffective components are removed; the 5 medicinal materials of the baical skullcap root, the peucedanum root, the blackberry lily, the coltsfoot flower and the white mulberry root-bark belong to alcohol-soluble components, and in order to better obtain the components, an effective part is directly obtained by adopting an alcohol extraction method, so that better medicinal material components can be obtained.

Detailed Description

The following experiments were carried out under conventional conditions or conditions suggested by the manufacturer, and the raw materials or auxiliary materials and the reagents or instruments used were conventional products available commercially, unless the specific conditions were noted. 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 can be used in the practice of the present invention.

The following description of the methods of preparation of the compositions or formulations of the present invention will only be given by way of example of the methods of preparation of the present invention, but it should not be understood that the methods of preparation of the present invention are limited to the methods of preparation described above.

Example 1 preparation of composition granules

200g of ephedra, 330g of bitter apricot kernel, 200g of perilla fruit, 660g of white mulberry root-bark, 528g of baical skullcap root, 330g of cicada slough, 330g of stiff silkworm, 660g of earthworm, 330g of radix peucedani, 330g of blackberry lily, 660g of coltsfoot flower, 330g of rhizoma pinellinae praeparata and 200g of liquoric root.

Decocting herba Ephedrae, semen Armeniacae amarum, fructus Perillae, rhizoma Pinelliae Preparata, and Glycyrrhrizae radix with 10 times of water for 2 times (each for 1.5 hr), filtering, concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.05-1.10 (60deg.C), cooling to room temperature, adding ethanol to alcohol content of 75%, standing for more than 24 hr, collecting supernatant, concentrating under reduced pressure until no alcohol smell is present, and obtaining extract 1. Reflux-extracting Scutellariae radix, radix Peucedani, rhizoma Belamcandae, flos Farfarae, and cortex Mori with 8 times of 70% ethanol for 2 times each for 1.0 hr, filtering, and concentrating the filtrate under reduced pressure until no alcohol smell is present to obtain extract 2. Decocting periostracum Cicadae, bombyx Batryticatus and Lumbricus with 8 times of water for 2 times (each time for 1.5 hr), filtering, concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.08-1.10 (60deg.C) to obtain extract 3. Mixing the extract 1, the extract 2 and the extract 3, concentrating under reduced pressure to obtain wet extract with a relative density of 1.23-1.25 (60 ℃), drying under reduced pressure (70 ℃) to obtain dry extract powder, pulverizing to obtain composition particles, adding a proper amount of dextrin, mixing uniformly, granulating by a wet method, spray-drying, and making into granules.

Example 2 preparation of composition capsules

100g of ephedra, 100g of bitter apricot seed, 100g of perilla seed, 300g of white mulberry root-bark, 300g of baical skullcap root, 100g of cicada slough, 100g of stiff silkworm, 300g of earthworm, 100g of whiteflower hogfennel root, 100g of blackberry lily, 300g of coltsfoot flower, 100g of rhizoma pinellinae praeparata and 100g of liquoric root.

Decocting herba Ephedrae, semen Armeniacae amarum, fructus Perillae, rhizoma Pinelliae Preparata, and Glycyrrhrizae radix with 10 times of water for 2 times (each for 1.5 hr), filtering, concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.05-1.10 (60deg.C), cooling to room temperature, adding ethanol to alcohol content of 75%, standing for more than 24 hr, collecting supernatant, concentrating under reduced pressure until no alcohol smell is present, and obtaining extract 1. Reflux-extracting Scutellariae radix, radix Peucedani, rhizoma Belamcandae, flos Farfarae, and cortex Mori with 8 times of 70% ethanol for 2 times each for 1.0 hr, filtering, and concentrating the filtrate under reduced pressure until no alcohol smell is present to obtain extract 2. Decocting periostracum Cicadae, bombyx Batryticatus and Lumbricus with 8 times of water for 2 times (each time for 1.5 hr), filtering, concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.08-1.10 (60deg.C) to obtain extract 3. Mixing the above extract 1, extract 2 and extract 3, concentrating under reduced pressure to obtain wet extract with relative density of 1.23-1.25 (60deg.C), drying under reduced pressure (70deg.C), pulverizing, and making into oral capsule.

Example 3 preparation of composition tablets

120g of ephedra, 180g of bitter apricot kernel, 120g of perilla fruit, 360g of white mulberry root-bark, 240g of baical skullcap root, 180g of cicada slough, 180g of stiff silkworm, 360g of earthworm, 180g of peucedanum root, 180g of blackberry lily, 360g of coltsfoot flower, 180g of rhizoma pinellinae praeparata and 120g of liquoric root.

Decocting herba Ephedrae, semen Armeniacae amarum, fructus Perillae, rhizoma Pinelliae Preparata, and Glycyrrhrizae radix with 10 times of water for 2 times (each for 1.5 hr), filtering, concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.05-1.10 (60deg.C), cooling to room temperature, adding ethanol to alcohol content of 75%, standing for more than 24 hr, collecting supernatant, concentrating under reduced pressure until no alcohol smell is present, and obtaining extract 1. Reflux-extracting Scutellariae radix, radix Peucedani, rhizoma Belamcandae, flos Farfarae, and cortex Mori with 8 times of 70% ethanol for 2 times each for 1.0 hr, filtering, and concentrating the filtrate under reduced pressure until no alcohol smell is present to obtain extract 2. Decocting periostracum Cicadae, bombyx Batryticatus and Lumbricus with 8 times of water for 2 times (each time for 1.5 hr), filtering, concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.08-1.10 (60deg.C) to obtain extract 3. Mixing the above extract 1, extract 2 and extract 3, concentrating under reduced pressure to obtain wet extract with relative density of 1.23-1.25 (60deg.C), drying under reduced pressure (70deg.C), pulverizing, and making into oral tablet by conventional method.

Example 4 preparation of pellets of the composition

60g of ephedra, 80g of bitter apricot seed, 60g of perilla fruit, 150g of white mulberry root-bark, 150g of baical skullcap root, 80g of cicada slough, 80g of stiff silkworm, 150g of earthworm, 80g of peucedanum root, 80g of blackberry lily, 150g of coltsfoot flower, 80g of rhizoma pinellinae praeparata and 60g of liquoric root.

Decocting herba Ephedrae, semen Armeniacae amarum, fructus Perillae, rhizoma Pinelliae Preparata, and Glycyrrhrizae radix with 10 times of water for 2 times (each for 1.5 hr), filtering, concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.05-1.10 (60deg.C), cooling to room temperature, adding ethanol to alcohol content of 75%, standing for more than 24 hr, collecting supernatant, concentrating under reduced pressure until no alcohol smell is present, and obtaining extract 1. Reflux-extracting Scutellariae radix, radix Peucedani, rhizoma Belamcandae, flos Farfarae, and cortex Mori with 8 times of 70% ethanol for 2 times each for 1.0 hr, filtering, and concentrating the filtrate under reduced pressure until no alcohol smell is present to obtain extract 2. Decocting periostracum Cicadae, bombyx Batryticatus and Lumbricus with 8 times of water for 2 times (each time for 1.5 hr), filtering, concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.08-1.10 (60deg.C) to obtain extract 3. Mixing the above extract 1, extract 2 and extract 3, concentrating under reduced pressure to obtain wet extract with relative density of 1.23-1.25 (60deg.C), drying under reduced pressure (70deg.C), pulverizing, and making into oral pill by conventional method.

Example 5 preparation of oral liquid composition

100g of ephedra, 150g of bitter apricot kernel, 100g of perilla fruit, 250g of white mulberry root-bark, 200g of baical skullcap root, 150g of cicada slough, 150g of stiff silkworm, 250g of earthworm, 150g of peucedanum root, 150g of blackberry lily, 250g of coltsfoot flower, 150g of rhizoma pinellinae praeparata and 100g of liquoric root.

Decocting herba Ephedrae, semen Armeniacae amarum, fructus Perillae, rhizoma Pinelliae Preparata, and Glycyrrhrizae radix with 10 times of water for 2 times (each for 1.5 hr), filtering, concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.05-1.10 (60deg.C), cooling to room temperature, adding ethanol to alcohol content of 75%, standing for more than 24 hr, collecting supernatant, concentrating under reduced pressure until no alcohol smell is present, and obtaining extract 1. Reflux-extracting Scutellariae radix, radix Peucedani, rhizoma Belamcandae, flos Farfarae, and cortex Mori with 8 times of 70% ethanol for 2 times each for 1.0 hr, filtering, and concentrating the filtrate under reduced pressure until no alcohol smell is present to obtain extract 2. Decocting periostracum Cicadae, bombyx Batryticatus and Lumbricus with 8 times of water for 2 times (each time for 1.5 hr), filtering, concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.08-1.10 (60deg.C) to obtain extract 3. Mixing the above extract 1, extract 2 and extract 3, concentrating under reduced pressure to obtain wet extract with relative density of 1.23-1.25 (60deg.C), drying under reduced pressure (70deg.C), pulverizing, and making into oral liquid by conventional method.

Pharmacological test

The composition particles of the present invention, as well as the comparative example particles, were prepared by Jiangsu Kangyuan pharmaceutical Co., ltd, and are specifically as follows:

the preparation method of the composition particles comprises the following steps: 8kg of ephedra herb, 13.2kg of bitter apricot kernel, 8kg of perilla fruit, 26.4kg of white mulberry root-bark, 21.2kg of baical skullcap root, 13.2kg of cicada slough, 13.2kg of stiff silkworm, 26.4kg of earthworm, 13.2kg of whiteflower hogfennel root, 13.2kg of blackberry lily, 26.4kg of coltsfoot flower, 13.2kg of rhizoma pinellinae praeparata and 8kg of liquoric root are taken as a sample after crushing the dry paste prepared by the process of the embodiment 1 of the invention.

Comparative example granule preparation method: 8kg of roasted ephedra, 10kg of almond, 20kg of white mulberry root-bark, 16kg of baical skullcap root, 10kg of cicada slough, 10kg of stiff silkworm, 20kg of earthworm, 10kg of ginkgo, 10kg of peucedanum root, 10kg of blackberry lily, 20kg of aster, 10kg of pinellia tuber and 6kg of liquoric root are taken, decocted and extracted twice with 10 times of water for 2 hours each time, the two extracted solutions are combined, concentrated, dried in vacuum and crushed to obtain the comparative example particles.

The composition granules and the comparative granules of the following experimental examples were prepared by the above method.

Experimental example 1 Effect on OVA-induced guinea pig acute bronchial asthma model

Experimental materials

Animals: guinea pigs are of normal grade, are male and female, and are 100 in total, and weight is 180-200 g. Provided by the south kyo city, pu's district, lyfu farms, license number: SCXK (Su) 2014-0004.

Medicament: terbutaline sulfate tablet: african pharmaceutical Co., ltd., lot number: 1611098; asthma-relieving tablet: correction pharmaceutical group stock, lot number: 160201.

reagent: ovalbumin: OVA, shanghai source leaf biotechnology limited, lot.no. an1121ga14; quick rayleigh dye liquor: nanjing builds up a science and technology Co., ltd., lot.No.20170323; eosinophil direct count solution: nanjing builds the institute of biological engineering, lot.No.20170223.

Instrument and consumable: ultra low temperature refrigerator (Haier Co., model: DW-86L 728); electronic balance (Sartorius scientific instruments model: BSA 224S-CW); refrigerator (SIEMENS Co., model: BCD-254); centrifuge (XiangYi Co., ltd.: L420); 402AI ultrasonic atomizer (Jiangsu Yuyu medical equipment Co., ltd., model: 140408832); slide glass (sailboard slide glass cat.no. 7101); syringes (Shanghai Kang Delai KDL company development group Co., ltd., specification: 1ml, 2 ml).

Experimental method

Animals were started after 7 days of adaptive feeding, and groups of guinea pigs were intraperitoneally injected with 10% OVA1ml (in saline). The behavioral signs of the test guinea pigs were also observed and scored according to the following criteria: tremor or nodding was 1 minute, cough or respiratory deepening was 2 minutes, rhythmic abdominal crunchiness dyspnea was 3 minutes, and fall was 6 minutes to score for the most severe behavioural sign of appearance. The behavioural score was randomly divided into model group, terbutaline sulfate tablet group, chuanlanning tablet group, composition (low, medium and high dose) group, and comparative example (low, medium and high dose) group (the composition and comparative example group each calculated dose based on the amount of crude drug administered). The corresponding drug administration was started on day 8 of each administration group, wherein the model group was administered physiological saline at 1ml/100g for 7 consecutive days. On day 15, the model group and guinea pigs of each administration group were placed in a sealed glass nebulizer hood and nebulized with 1% OVA for 100s after 60min of last administration. The guinea pig asthma latency (time from onset of spray to asthma onset, onset of rhythmic, abdominal cramps, until twitch fall) was recorded, as exceeding 6min, and the above manifestations still did not appear, with latency calculated as 360 s. After the test, the guinea pigs were anesthetized, the trachea was isolated after exsanguination and sacrifice, the chest was opened, the right lung was ligated, the left lung was washed with phosphate buffered saline (PBS, pH 7.4), alveolar lavage fluid (BALF) was collected, and the levels of cytokines IL-4, IFN-gamma, igE, EOS in BALF were determined. The right lung tissue is fixed by 10% formaldehyde solution, dehydrated, embedded in paraffin, and made into 4 μm slice, hematoxylin-eosin (HE) staining is performed, and pathological changes of the lung tissue are observed under a light microscope. The pathological lesions were scored as follows: the degree of the lesions from light to heavy is respectively recorded as 0.5 to 4 points, and the integral standard is as follows: slight or very small amounts were scored as 0.5 score, slight lesions or a small amount as 1 score; moderate lesions or moderate scores 2; severe lesions or multiple scores 3 points; very severe lesions or large numbers were scored as 4 points. No lesions were scored as 0 points. And adding all scores to calculate the average score of the lesions of each group of animals.

The results show that: compared with the model group, after the composition and the comparative example granule are given, the asthma-inducing incubation period of the guinea pigs induced by OVA is obviously prolonged (P < 0.05), wherein the composition has obvious effect of delaying asthma attack at low, medium and high doses, and the effect is better than that of the comparative example. The IL-4 and IgE levels in the BALF of the middle and high dose groups of the comparative example showed significant differences (P < 0.05) compared to the model group, and the IFN-gamma levels in the BALF of the low, middle and high dose groups of the comparative example showed significant differences (P < 0.01), and the EOS count level in the BALF of the high dose group of the comparative example was significantly reduced; the compositions showed significant differences in IL-4 and IFN-gamma levels in the low, medium and high dose groups of BALF (P < 0.01), and significant decreases in IgE and EOS levels in the compositions and the high dose groups of BALF (P <0.05 and P < 0.01). In the aspect of pathological damage of lung tissues, the medium and high doses of the comparative example and the low, medium and high doses of the composition can obviously reduce inflammatory lesions of the lung, reduce the degree of emphysema (P <0.01 and P < 0.05), and have the best effect. The results are shown in tables 1, 2 and 3. Taken together, the above indexes show that the composition has the effects of remarkably improving the symptoms of acute asthma and airway inflammatory response, remarkably reducing the generation and release of anaphylactic substance IgE, reducing the local lung tissue infiltration of eosinophils, and remarkably resisting allergy, can be used for treating acute asthma and variant cough, and has better effect than that of a comparative example.

Table 1: effect on asthma latency in an OVA-induced guinea pig acute asthma model

Note that: p <0.05, < P <0.01 compared to model group.

Table 2: effect on IL-4, IFN-gamma, igE, EOS in OVA-induced guinea pig acute asthma model BALF

Note that: p <0.05, < P <0.01 compared to model group.

Table 3: effects on lung tissue pathology scores of OVA-induced guinea pig acute asthma model

Note that: p <0.05, < P <0.01 compared to model group.

Experimental example 2 Effect on histamine-induced guinea pig model of chronic bronchial asthma

Experimental materials

Animals: guinea pigs are of normal grade, are male and female, and have 100 weight and 220-250 g weight. Provided by the south kyo city, pu's district, lyfu farms, license number: SCXK (Su) 2014-0004.

Medicament: terbutaline sulfate tablet: african pharmaceutical Co., ltd., lot number: 1611098; asthma-relieving tablet: correction pharmaceutical group stock, lot number: 160201; comparative example granules, composition granules, were prepared by Jiangsu Kangyuan pharmaceutical Co., ltd.

Reagent: histamine phosphate: shanghai Source leaf Biotechnology Co., ltd., lot number: a17O7D22934; acetylcholine chloride: shanghai Yuan Yes Biotechnology Co., ltd., lot D05M8B35414; quick rayleigh dye liquor: nanjing builds up a science and technology Co., ltd., lot.No.20170323; eosinophil direct count solution: nanjing builds the institute of biological engineering, lot.No.20170223.

Experimental method

After 7 days of adaptive feeding, a plurality of pre-selected guinea pigs are respectively placed in a spray box, an equal volume of asthma inducing mixed solution of 2% acetylcholine chloride (10 g of acetylcholine chloride is dissolved in 500mL of physiological saline) and 0.05% histamine phosphate (0.25 g of histamine phosphate is dissolved in 500mL of physiological saline) is added for spray induced asthma for 15s, and the asthma inducing incubation period (namely, the time from the start of spraying to the twitch and fall of the guinea pigs) of the guinea pigs is observed and recorded, so that the mice can be considered insensitive and are not selected for more than 150 s. The pre-selected guinea pigs were randomly divided into model, terbutaline sulfate, chuanlaning, comparative (low, medium, high dose) and composition (low, medium, high dose) groups. The cough and asthma of each group of guinea pigs was continuously induced by the asthma-inducing liquid, and the spray was continued for 10s per day for 21 days. The corresponding medicine is given to each administration group at the same time of chronic asthma induction, wherein the model group is given normal saline at the concentration of 1ml/100g for 21 days. The asthma test was repeated according to the above screening method 60min after the last administration of guinea pigs, and the asthma latency time was recorded. After the test, the guinea pigs were anesthetized, the trachea was isolated after exsanguination and sacrifice, the chest was opened, the right lung was ligated, the left lung was washed with phosphate buffered saline (PBS, pH 7.4), alveolar lavage fluid (BALF) was collected, and the levels of cytokines IL-4, IFN-gamma, igE, EOS in BALF were determined. The right lung tissue is fixed by 10% formaldehyde solution, dehydrated, embedded in paraffin, and made into 4 μm slice, hematoxylin-eosin (HE) staining is performed, and pathological changes of the lung tissue are observed under a light microscope. The pathological lesions were scored as follows: the integral standard is that the slight or very small amount is recorded as 0.5 point and the slight pathological change or the small amount is recorded as 1 point according to the degree from light to heavy of the pathological change respectively as 0.5 to 4 points; moderate lesions or moderate scores 2; severe lesions or multiple scores 3 points; very severe lesions or large numbers were scored as 4 points. No lesions were scored as 0 points. And adding all scores to calculate the average score of the lesions of each group of animals.

The results show that: compared with the model group, after the composition and the comparative example particles are given, the asthma-inducing incubation period of the guinea pigs induced by OVA is obviously prolonged (P <0.05 and P < 0.01), wherein the low, medium and high doses of the composition show obvious effect of delaying asthma attack, and the effect is better than that of the comparative example. The levels of IL-4 and IgE in the BALF of the medium and high dose groups showed significant differences (P <0.05, P < 0.01) compared to the model group, and the IFN-gamma and EOS counts in the BALF of the high dose group showed significant differences (P <0.05, P < 0.01); the low, medium and high dose groups of the composition all showed significant differences in the IgE levels of BALF (P < 0.05), the medium and high dose groups of the composition showed significant differences in the IL-4, EOS count levels of BALF (P <0.01, P < 0.05), and the IFN- γ levels in the high dose group of the composition were significantly elevated (P < 0.01). In the aspect of pathological damage of lung tissues, the medium and high doses of the comparative example and the low, medium and high doses of the composition can obviously reduce inflammatory lesions of the lung, reduce the degree of emphysema (P <0.01 and P < 0.05), and have the best effect. The results are shown in tables 4, 5 and 6. Taken together, the above indexes show that the composition has the effects of remarkably improving chronic asthma symptoms and airway inflammatory reactions, remarkably reducing the generation and release of anaphylactic substance IgE, reducing the local lung tissue infiltration of eosinophils, and remarkably resisting allergy, can be used for treating chronic asthma and variant cough, and has better effect than that of a comparative example.

Table 4: effect on asthma latency in histamine-induced guinea pig chronic asthma model

Note that: p <0.05, < P <0.01 compared to model group.

Table 5: effect on IL-4, IFN-gamma, igE, EOS in histamine-induced guinea pig chronic asthma model BALF

Note that: p <0.05, < P <0.01 compared to model group.

Table 6: effects on lung tissue pathology scores in histamine-induced guinea pig chronic asthma models

Note that: p <0.05, < P <0.01 compared to model group.

Experimental example 3 Effect on guinea pig Ammonia cough model

Experimental materials

Medicament: terbutaline sulfate tablet: african pharmaceutical Co., ltd., lot number: 1611098; asthma-relieving tablet: correction pharmaceutical group stock, lot number: 160201; comparative example granules, composition granules, prepared by Jiangsu Kangyuan pharmaceutical Co., ltd;

reagent: ammonia water: 28% NH4OH, national drug group chemical Co., ltd., lot number: 20150106

Instrument: YLS-8A multifunctional cough and asthma inducing instrument for treating cough and asthma

Experimental method

Animals were tested after 7 days of adaptive feeding, the first day spraying ammonia (28% NH) with a cough and asthma inducing instrument ₄ OH) for 5 seconds. The number of guinea pigs (48) with positive cough reflex (more than 10 times cough within 3 min) is selected (cough standard is that abdominal muscle is contracted, and simultaneously the mouth is opened, and cough can occur in some cases). The compositions were randomly divided into 9 groups according to body weight, namely, model group, terbutaline sulfate tablet group, chuanlanning tablet group, comparative example (low, medium and high dose) group and composition (low, medium and high dose) group. The male and female animals are fed in separate cages, and picric acid is used for marking after grouping. Each group was dosed 24 hours after completion of the grouping, wherein the model group was dosed with physiological saline at 1ml/100g for 7 days continuously, and after the last dose was given for 60 minutes, guinea pigs were stimulated in the same manner, and the latency of cough and the number of cough within 5 minutes after the dose were recorded, and the latency prolongation percentage and the cough reduction percentage were calculated as evaluation indexes.

The experimental results show that: the medium and high dose groups reduced the number of coughs and latency (p <0.05, p < 0.01) in guinea pigs within 5 minutes compared to the model group; the low, medium and high doses of the composition reduced the incubation period of cough in guinea pigs for 5 minutes (p <0.05, p < 0.01), and the medium and high doses reduced the number of cough in guinea pigs for 5 minutes (p < 0.05), and the results are shown in Table 7. Compared with the traditional Chinese medicine composition, the traditional Chinese medicine composition has the effect of obviously relieving cough symptoms, can be used for treating cough caused by asthma, bronchitis and the like, and has better effect than that of a comparative example.

Table 7: influence on cough latency and cough times of ammonia-induced cough guinea pig model

Note that: p <0.05, < P <0.01 compared to model group.

Experimental example 4 Effect on acute rat pharyngitis model

Experimental materials

Animals: 90 SD rats, each half of male and female, 200-220g; SPF-grade, supplied by Peking Vietnam Lihua laboratory animal technologies Co., ltd., license number: SCXK (jing) 2012-0001.

Medicament: pudi blue anti-inflammatory tablet (0.6 g/tablet, lot number: 20150306, guangdong Xinbao pharmaceutical Co., ltd.); comparative example granules, composition granules, prepared by Jiangsu Kangyuan pharmaceutical Co., ltd;

reagent: ammonia water: 28% NH ₄ OH, national pharmaceutical group chemical reagent limited, lot number: 20150106

Instrument and consumable: electronic balance (Sartorius scientific instruments model: BSA 224S-CW); fully automatic blood analyzers (model ADVIA 2120 from Simens, germany); throat sprayer, manufactured by medical equipment factory in Jiading area of Shanghai city.

Experimental method

The animals were subjected to the experiment after 7 days of the adaptive feeding, the oral cavity of the rat was widened, and except for the blank group, the rest groups were sprayed with 25% ammonia water by using a throat sprayer twice a day, 3 lifting each time, and molding was performed for 3 days. In operation, it is ensured that no liquid droplets flow into the trachea. The experiments were carried out in normal group, model group, pu Di lan anti-inflammatory tablet control group, comparative example (low, medium and high dose) group and composition (low, medium and high dose) group. Each group of 10. Each dosing group was dosed with the corresponding drug starting on day 4 of the experiment, with the model and normal groups dosed with saline at 1ml/100g for 7 consecutive days. Observing the states of animal diet, activity and the like during administration modeling and administration period. Each group of rats was visually observed for pharyngeal condition 1h after the last dose. And recorded according to the following evaluation criteria: integral 3, frequently scratching the mouth, drinking water, and causing congestion and swelling of the pharynx, and fresh red mucous membrane; integral 2, pharyngeal swelling, partial congestion; integral 1, swollen pharynx, no congestion; integral 0, no this. The rats were anesthetized and anticoagulated with abdominal aortic blood for white blood cell count.

The experimental results show that: compared with the model group, the middle and high dose groups can relieve symptoms such as pharyngeal congestion and swelling (p <0.05, p < 0.01), and the low, middle and high dose groups can relieve symptoms such as pharyngeal congestion and swelling (p <0.05, p < 0.01), and compared with the model group, the combination has better effect than the comparative example; the results of the comparative examples and compositions, in which the high dose groups reduced the white blood cell count to varying degrees and the classification were not significantly different, are shown in tables 8 and 9. The combination of the two results proves that the composition has the functions of obviously improving the symptoms of acute pharyngitis and relieving inflammatory reaction, can be used for treating the symptoms of pharyngitis, pharyngeal congestion, swelling and the like, and has better effect than the comparative example.

Table 8: effect of the composition on local pharyngeal symptoms in rats with acute pharyngitis

Table 9: effect of the composition on white blood cell count and classification in rats with acute pharyngitis

The composition provided by the invention not only has the effect of preventing or treating asthma and cough, but also has better effect of improving the pathological changes of the throat, and the pharmacological effect is verified by related experiments.

The prescription is composed of 13 medicinal materials of ephedra, bitter apricot seed, perilla seed, white mulberry root-bark, baikal skullcap root, cicada slough, stiff silkworm, earthworm, peucedanum root, blackberry lily, tussilago farfarfara, rhizoma pinellinae praeparata and liquorice. Compared with the comparative formula, the formula has the advantages that the convergence of gingko is removed, so that the smooth flow of lung and intestine qi is prevented, and the impairment of the healthy energy by small toxin is avoided; the perilla fruit and perilla fruit are added to reduce qi and relieve asthma, so that the effects of eliminating phlegm and relieving cough are strong; the tussilago farfara flower is added, bitter in flavor and descending in flavor, qi and fragrance are mainly dispersed, lung moistening and qi descending are performed, phlegm eliminating and cough relieving effects are achieved, and the almond is added to reduce qi to relieve cough, eliminate phlegm and moisten lung, so that the effect of increasing phlegm is achieved. The whole formula has the effects of ventilating lung, relieving spasm, relieving asthma, clearing heat, reducing qi and resolving phlegm.

The above examples of the present invention are merely illustrative of the present invention and are not intended to limit the embodiments of the present invention. Other variations or modifications of the above teachings will be apparent to those of ordinary skill in the art. It is not necessary here nor is it exhaustive of all embodiments. Any modification, equivalent replacement, improvement, etc. which come within the spirit and principles of the invention are desired to be protected by the following claims.

Claims

1. The traditional Chinese medicine composition is characterized by being prepared from the following raw materials in parts by weight: 0.61 part of ephedra herb, 1 part of bitter apricot seed, 0.61 part of perilla fruit, 2 parts of white mulberry root-bark, 1.6 parts of baical skullcap root, 1 part of cicada slough, 1 part of stiff silkworm, 2 parts of earthworm, 1 part of peucedanum root, 1 part of blackberry lily, 2 parts of coltsfoot flower, 1 part of rhizoma pinellinae praeparata and 0.61 part of liquoric root; the preparation method of the traditional Chinese medicine composition comprises the following steps:

decocting herba Ephedrae, semen Armeniacae amarum, fructus Perillae, rhizoma Pinelliae Preparata, and Glycyrrhrizae radix with 10 times of water for 2 times, each time for 1.5 hr, filtering, concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.05-1.10 at 60deg.C, cooling to room temperature, adding ethanol to alcohol content of 75%, standing for more than 24 hr, collecting supernatant, concentrating under reduced pressure until no alcohol smell is present to obtain extract 1; reflux extracting Scutellariae radix, radix Peucedani, rhizoma Belamcandae, flos Farfarae, and cortex Mori with 8 times of 70% ethanol for 2 times each for 1.0 hr, filtering, concentrating the filtrate under reduced pressure until no alcohol smell exists to obtain extract 2; decocting periostracum Cicadae, bombyx Batryticatus and Lumbricus with 8 times of water for 2 times (each for 1.5 hr), filtering, concentrating the filtrate under reduced pressure to obtain extract 3 with relative density of 1.08-1.10 at 60deg.C; mixing extract 1, extract 2 and extract 3, concentrating under reduced pressure to obtain wet extract with relative density of 1.23-1.25 at 60deg.C, and drying under reduced pressure at 70deg.C.

2. The preparation method of the traditional Chinese medicine composition according to claim 1, which comprises the following steps:

3. The use of a Chinese medicinal composition according to claim 1 in the manufacture of a medicament for asthma.

4. The use of a Chinese medicinal composition according to claim 1 in the preparation of a medicament for pharyngitis.

5. The use of the Chinese medicinal composition according to claim 1 in the preparation of a medicament for cough.

6. A medicament, which is characterized by comprising the traditional Chinese medicine composition of claim 1 and pharmaceutically acceptable auxiliary materials.

7. The medicament according to claim 6, wherein the medicament is selected from the group consisting of tablets, capsules, granules, pills, injections, ointments, suspensions, dispersions, syrups, suppositories, gels, aerosols, patches and oral liquids.