CN113559207A

CN113559207A - Traditional Chinese medicine composition for clearing lung, eliminating phlegm, relieving cough and asthma and application thereof

Info

Publication number: CN113559207A
Application number: CN202110991429.1A
Authority: CN
Inventors: 张海; 范晓波; 董秀
Original assignee: Guizhou Youkean Biotechnology Co ltd
Current assignee: Guizhou Youkean Biotechnology Co ltd
Priority date: 2018-11-22
Filing date: 2018-11-22
Publication date: 2021-10-29
Also published as: CN109239239B; CN109239239A

Abstract

The invention relates to a traditional Chinese medicine composition for clearing lung, eliminating phlegm, relieving cough and asthma, a preparation method and application thereof. In particular, one aspect relates to a traditional Chinese medicine composition, which is prepared from traditional Chinese medicinal materials including scutellaria baicalensis, concretio silicea bambusae and the like and optional pharmaceutical excipients, wherein each medicinal material is added into the composition in the form of medicinal material powder, or in the form of an extract of the medicinal material powder and one or more other medicinal materials; the Chinese medicinal composition is, for example, an external preparation, such as a patch, an ointment, a cream, etc.; the traditional Chinese medicine composition is an oral preparation for example; such as granules, tablets, capsules, oral liquids, granules, pills, sprays and the like. The invention uses a simple traditional Chinese medicine composition to treat cough with lung heat, profuse phlegm, wheeze, yellow phlegm, red tongue and yellow fur and other diseases caused by various reasons, and particularly can be effectively used for clearing lung, eliminating phlegm, relieving cough and relieving asthma for children patients.

Description

Traditional Chinese medicine composition for clearing lung, eliminating phlegm, relieving cough and asthma and application thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, relates to a traditional Chinese medicine composition for clearing lung, eliminating phlegm and relieving cough and asthma, and also relates to a method for preparing the traditional Chinese medicine composition for clearing lung, eliminating phlegm and relieving cough and asthma, and pharmaceutical application of the traditional Chinese medicine composition for clearing lung, eliminating phlegm and relieving cough and asthma. More particularly, the invention uses a few traditional Chinese medicines such as scutellaria baicalensis and the like, realizes effective lung clearing, phlegm eliminating, cough relieving and asthma relieving, and can be particularly used in a convenient administration way, such as for children patients.

Background

Cough is the most common symptom of respiratory diseases and is a protective defense function of the human body. Cough can discharge secretions from the respiratory tract or foreign matters invading the trachea, and dry cough, which is only cough without phlegm, is seen in various diseases. The causes of cough are various, for example, chronic pharyngitis: patients have dry pharynx with pruritus and discomfort, and gusty cough sound is stimulated by the stimulation, the rough mucosa surface of the posterior pharyngeal wall can be found by opening the mouth towards a mirror, and the throat has a plurality of dilated small blood vessels, and in severe cases, the throat has transparent small white bubbles, which is common in simplicity. Chronic laryngitis: if the patient has dry cough accompanied by hoarseness, dry and itchy throat and hot and spicy pain, it may be laryngitis. Chronic bronchitis: more middle-aged people often cough, expectorate more or less viscous sputum, aggravate after waking in the morning, attack in winter and spring every year, relieve or relieve in summer, and severe or prolonged patients find the thoracic broadening, which is suspected to be chronic bronchitis. Bronchial asthma: if the cough is recurrent, and if the patient feels chest tightness, dyspnea, cough may be induced every cold season or exposure to an allergic substance while breathing is occurring between throats such as a saw, it should be checked whether bronchial asthma is present. Pulmonary tuberculosis, lung cancer: the patient has low cough, sputum with blood or hemoptysis, feels general weakness, has less meal, gradually diminishes body, has high body temperature in the afternoon and at night, has increased sweating during sleep, is palpitation and has red cheeks. Infectious cough: respiratory diseases such as viral or bacterial upper respiratory infections can also cause cough. Cough for other reasons: cough can also be caused by diseases such as foreign body in trachea, pleurisy, pleural effusion and many physical and chemical factors. Lung moistening and cough relieving refers to the treatment of cough due to yin deficiency by using yin nourishing and lung moistening traditional Chinese medicines, and also has a treatment effect of traditional Chinese medicine.

Cough, dyspnea and phlegm and saliva are closely related in pathogenesis, cough and dyspnea usually carry phlegm, and cough and dyspnea are usually caused by excessive phlegm. Cough, one of the most common symptoms of respiratory diseases, is a protective nerve reflex which can expel foreign bodies or secretions in respiratory tracts out of the body by the action of respiratory impact generated by cough. Cough can be divided into dry and wet. Dry cough with a faint, deep and burning sensation and without expectoration. It is common in the early stages of common cold, bronchitis and pneumonia. A long lasting dry cough, probably tuberculosis. The symptoms of wet cough are that the cough is incessant and the throat has phlegm. According to the traditional Chinese medicine, cough is caused by pathogenic factors attacking the lung system, the lung fails to disperse and descend, and the lung qi is unclear. According to the theory of traditional Chinese medicine, aiming at the pathogenesis of cough, dialectical compatibility formula is carried out by taking heat clearing and detoxifying, lung moistening and phlegm reducing, cough relieving and asthma relieving as the treatment principle so as to achieve the purpose of treating both principal and secondary aspect of disease.

Cough asthma, also known as cough variant asthma, refers to a specific type of asthma with chronic cough as the main or only clinical manifestation. Cough is the only or major clinical symptom without obvious wheezing, but has airway hyperreactivity, mainly manifested as irritant dry cough, and the cough at night is particularly serious. The current research considers that the disease is mainly caused by the interaction of various inflammatory mediators, cytokines and inflammatory cells. In addition, the medicine also comprises various factors such as nerve factors, infection factors, genetic factors and the like. The traditional medicine considers that the lung is a delicate organ, if the lung is invaded by exogenous pathogenic factors, the lung cannot be normally dispersed and descended, and the adverse rising of qi is clinically manifested as cough, adverse rising of lung qi and wind-type contracture urgency, which is characterized by causing the contracture urgency of air passages, and is equivalent to the change of bronchospasm in western medicine. The pathogenesis of the disease is that the external infection is treated and pathogenic factors stagnate in the lung, so that the lung qi fails to disperse, the lung duct is unfavorable, and the airway is contracture and urgent. Or in the early stage of the disease, cold and cool or large dose of antibiotics are used to cause cold pathogen to stagnate in the lung, so that the lung can not resist cold and heat, can only receive the qi of the heart and can not receive external vital energy, the pathogenic qi stagnates in the lung, the dispersing, purifying and descending functions of the lung are disordered, and the tissue form of the lung tube is changed, thereby causing the tracheal spasm. Cough asthma belongs to the categories of cough, asthma syndrome and the like in traditional Chinese medicine, and frequently occurs in spring and alternate autumn and winter. It is usually caused by the failure of treating exogenous pathogenic factors, dryness of lung by pathogenic factors, adverse flow of wind-qi, and shortness of breath and phlegm obstruction. The disease has the characteristics of repeated attack, acute attack, rapid onset and the like, and the disease has the premonitory symptoms of sneezing, nasopharynx airway itching, nasal discharge, chest distress and the like before the attack, and is consistent with the characteristics of wind as yang pathogen and opening of nature. Wind is the head of six excesses, other exogenous pathogenic factors usually attack the body with wind, and cough due to exogenous pathogenic factors is usually led by wind, or accompanied by cold, or accompanied by heat, or accompanied by dryness, or accompanied by phlegm, among which the majority of patients are involved. It can be known that wind pathogen is one of the main pathogenic factors in the generation, development and evolution of the disease, and the accompanying pathogenic factors are only one of the triggering factors and not the intrinsic factors.

Further, bronchial asthma in children is a common disease and frequently encountered disease in childhood, and is an airway chronic morbid reactive disease involving a variety of inflammatory cells such as eosinophils, mast cells, and T lymphocytes, and cytokines. Bronchial asthma can occur in different seasons, especially in cold winter and when the climate temperature changes rapidly. The disease can be induced by weak body or touching the children with phlegm in the lung caused by the following factors: it is commonly seen in the cases of wind-cold. Mental irritation, depression, or environmental shock, inhalation of human dust, and eating. As the children are immature and have low disease resistance, the children belong to the body of young yin and yang, the viscera are delicate and tender, the shape and qi are not sufficient, the lung and the spleen are deficient and easy to be deficient and excessive, the phlegm stagnation is easy to be transformed into heat for a long time, and the clinical manifestations of the children are mostly cold and heat mixed with deficiency and excess. The child has immature viscera. Because human skin belongs to the lung to be managed, the lung is delicate, the skin has poor external defense function, the skin is not dense in the striae, wind cold and wind heat invade the human body from skin and hair or mouth and nose, the kidney deficiency causes the dysfunction of spleen, lung and kidney to cause the formation of phlegm-fluid, pathogenic qi invades the lung to cause the phlegm-fluid, the phlegm rises along with the qi, the qi is mutually stimulated due to the phlegm blockage, the air passage is blocked, and the ascending and descending of the qi activity are not good, so that the exhaled breath is more and less, the breath is breathed quickly, and the throat is wheezed and has whitish phlegm. The symptoms are: sudden and rapid respiration, sudden onset, stuffy breath, wheezing sound in the throat and inability to lie flat. It usually occurs in paroxysmal attack, or with symptoms of dysphoria, sweating, cough with phlegm, purplish cough, pale complexion, and unclear spirit.

The treatment of cough, asthma or wheeze usually involves various symptomatic treatments such as relieving cough, resolving phlegm, relieving asthma, etc. Most western medicines are treated by compound medicines, however, when the western medicines are used for treating children, the potential side effects of the western medicines are often worried about, and the treatment by adopting the traditional Chinese medicine method is often considered.

In the prior art, a plurality of traditional Chinese medicine technologies for clearing lung, eliminating phlegm, relieving cough and relieving asthma are reported. For example, CN107970332A (application No. 201610905181.1, Hedychium coronarium) discloses a medicine for treating bronchial asthma, which comprises the following components: gecko, pseudostellaria heterophylla maxim, pumice, fermented soybean, lumbricus, aster, Chinese honeylocust fruit, prepared arisaema tuber, asarum, roasted scutellaria baicalensis, stalactite, cortex mori radicis, schisandra chinensis, agilawood, stir-fried mustard seed, almond, scutellaria baicalensis, raw keel and liquorice; the component ratio is as follows: 6g of gecko (removing head and feet), 30g of juvenile ginseng, 30g of pumice (decocted first), 10g of fermented soybean, 10g of lumbricus, 10g of aster, 3g of Chinese honeylocust fruit, 6g of prepared arisaema tuber, 6g of asarum, 6g of roasted scutellaria baicalensis, 15g of stalactite (decocted first), 10g of cortex mori radicis, 10g of schisandra chinensis, 6g of agilawood, 6g of fried mustard seed, 10g of almond, 10g of scutellaria baicalensis, 20g of raw keel (decocted first) and 6g of liquorice.

CN107303340A (application No. 201610251388.1, Yangyou soldier) provides a Chinese medicinal composition for treating asthma, which comprises ginkgo, scutellaria baicalensis, flos farfarae, white mulberry root-bark, rhizoma pinellinae praeparata, perillaseed, liquorice and almond and scutellaria baicalensis, and the composition is believed to have the effects of benefiting lung, clearing heat, reducing phlegm and stopping asthma, and the clinical cure rate can reach more than 91%.

CN108210703A (application No. 201611160874.9, Wuhongxia) discloses a traditional Chinese medicine composition for treating children bronchial asthma, which is prepared from the following raw materials in parts by weight: 3-9 parts of folium artemisiae argyi, 5-10 parts of perilla leaf, 6-12 parts of cortex mori radicis, 3-9 parts of pericarpium citri reticulatae viride, 1-6 parts of schisandra chinensis, 3-10 parts of almond, 2-9 parts of scutellaria baicalensis, 3-9 parts of ginseng, 9-15 parts of poria cocos, 3-9 parts of platycodon grandiflorum, 3-9 parts of bulbus fritillariae cirrhosae, 3-9 parts of mint, 6-15 parts of pteris pterodon, 3-9 parts of rhizoma arisaematis and 1-10 parts of liquorice. The traditional Chinese medicine composition is believed to have the effects of sweating, dispelling cold, moistening lung, relieving asthma, eliminating phlegm, relieving cough, soothing liver, breaking qi, clearing heat and moistening lung, and also has the advantages of simple preparation process, good curative effect, low side effect, convenience in taking, easiness in popularization and application and the like.

CN108339046A (application No. 201710040144.3, Hao Tong) relates to a traditional Chinese medicine composition for treating cough, which comprises the following traditional Chinese medicine raw materials in parts by weight: 3-18 parts of angelica, 1-10 parts of roasted scutellaria baicalensis, 5-25 parts of mustard seed, 3-18 parts of cortex mori, 3-18 parts of bulbus fritillariae cirrhosae, 3-18 parts of scutellaria baicalensis, 3-18 parts of almond, 3-18 parts of stiff silkworm, 5-20 parts of adenophora stricta and 1-10 parts of liquorice. The traditional Chinese medicine composition disclosed by the invention has the effects of warming spleen and stomach for dispelling cold, clearing heat and removing toxicity, moistening lung for eliminating phlegm and relieving cough and asthma, and is remarkable in curative effect and reliable in effect on cough; the medicine has wide medicinal component source, simple preparation and no toxic or side effect.

CN108452161A (application No. 201710094478.9, Kanghui) relates to a traditional Chinese medicine composition for treating cough, which comprises the following traditional Chinese medicine raw materials in parts by weight: 3-18 parts of angelica, 1-10 parts of roasted scutellaria baicalensis, 5-25 parts of mustard seed, 3-18 parts of cortex mori, 3-18 parts of bulbus fritillariae cirrhosae, 3-18 parts of scutellaria baicalensis, 3-18 parts of almond, 3-18 parts of stiff silkworm, 5-20 parts of adenophora stricta and 1-10 parts of liquorice. The traditional Chinese medicine composition disclosed by the invention has the effects of warming spleen and stomach for dispelling cold, clearing heat and removing toxicity, moistening lung for eliminating phlegm and relieving cough and asthma, and is remarkable in curative effect and reliable in effect on cough; the medicine has wide medicinal component source, simple preparation and no toxic or side effect.

CN108465012A (application No. 201810663573.0, Baijian) discloses a traditional Chinese medicine for treating bronchial asthma, which is prepared from 6-10 parts by mass of scutellaria baicalensis, 3-6 parts by mass of asarum, 20-26 parts by mass of gypsum, 4-8 parts by mass of cassia twig, 10-12 parts by mass of red tangerine peel, 10-12 parts by mass of mustard seed, 20-30 parts by mass of astragalus membranaceus, 20-30 parts by mass of cortex mori, 10-14 parts by mass of fructus aurantii, 4-7 parts by mass of elecampane, 10-14 parts by mass of radix bupleuri, 10-14 parts by mass of folium mori, 10-14 parts by mass of honeysuckle, 8-12 parts by mass of flos farae and 8-12 parts by mass of folium eriobotryae; the radix Scutellariae should be stir-baked in advance, and the Gypsum Fibrosum should be unprocessed. The preparation method comprises preparing the Chinese medicinal materials according to the formula, wherein Scutellariae radix is processed in advance; oven drying all above materials, pulverizing into pieces, sterilizing, decocting in water for 3 times, and filtering to obtain extract; drying with middle fire, pulverizing, and grinding into powder; and finally pressing into tablets or filling into capsules. The traditional Chinese medicine is believed to have rapid and reliable curative effect and safe use, and is suitable for treating patients with bronchial asthma.

CN104352691A (application No. 201410749343.8, Jiangchun flower) provides a traditional Chinese medicine decoction for treating bronchial asthma, which is characterized by comprising the following raw material medicines in parts by weight: 25g of mustard seed, 9g of roasted scutellaria baicalensis, 9g of ginkgo seed meat, 9g of almond, 9g of pinellia ternate, 10g of tussilago farfara, 12g of white mulberry root-bark, 9g of scutellaria baicalensis, 12g of safflower, 12g of fructus aurantii and 6g of roasted liquorice.

CN107823328A (application No. 201711035291.8, Kingtang Haina) provides an oral administration medicine for treating infantile cough asthma according to the cognitive mechanism of traditional Chinese medicine for treating infantile cough asthma, and the medicine comprises the following components in parts by mass: 30-120 g of radix peucedani, 80-160 g of angelica sinensis, 30-70 g of gallnut, 30-100 g of mustard seed, 30-120 g of platycodon grandiflorum, 150-300 g of codonopsis pilosula, 150-350 g of cortex lycii radicis, 60-150 g of white mulberry root-bark, 30-100 g of donkey-hide gelatin, 100-160 g of poria cocos, 30-100 g of inula flower, 100-160 g of clam shell, 50-120 g of burdock, 25-150 g of scutellaria baicalensis, 60-150 g of dark plum, 25-70 g of coptis chinensis, 35-120 g of dried orange peel and auxiliary materials: the micro silica gel powder, the microcrystalline cellulose and the starch are proper; the medicament provided by the invention is believed to be a good traditional Chinese medicine formula.

CN108186832A (application No. 201810139225.3, Liuzhou Fuju) discloses a traditional Chinese medicine formula granule for treating children cough variant asthma and a preparation method thereof. The traditional Chinese medicine formula granule for treating children cough variant asthma is prepared from the following raw material components: roasted scutellaria baicalensis, cortex mori radicis, scutellaria baicalensis, Japanese ardisia herb, mustard seed, aster, coltsfoot flower, perilla fruit, earthworm, platycodon grandiflorum, stiff silkworm, rhizoma pinellinae praeparata, bitter apricot seed, honey-fried licorice root, dried orange peel, cicada slough and lactose. The traditional Chinese medicine formula granules for treating the cough variant asthma in children are elaborately developed according to the traditional Chinese medicine formula and the preparation principle, and the effective components are extracted according to the modern traditional Chinese medicine extraction technology, so that the traditional Chinese medicine formula granules have the characteristics of strong pertinence, good curative effect, short period and no toxic or side effect.

CN108653550A (application No. 201810749962.5, Tianchangyi Saimai) discloses a medicine for treating cough, a preparation method and a detection method thereof. The tussiculate, baical skullcap root and baical skullcap root cough-relieving medicine is prepared from the following medicinal raw materials in parts by weight: 110-125 g of honey-fried scutellaria baicalensis, 110-125 g of white mulberry root-bark, 225-240 g of honeysuckle, 110-125 g of scutellaria baicalensis, 205-220 g of thesium Chinese, 205-220 g of gypsum, 110-125 g of thunberg fritillary bulb, 110-125 g of bitter apricot kernel, 110-125 g of perilla fruit, 110-125 g of common coltsfoot flower, 110-125 g of mustard seed, 205-220 g of earthworm, 75-90 g of ginger processed pinellia tuber, 110-125 g of fried ginkgo seed and 75-90 g of honey-fried licorice root. The invention provides a method for simultaneously determining the content of active ingredients of a ephedra, radix scutellariae and cough-relieving medicine by adopting a high performance liquid chromatography, and also provides a new application of the ephedra, radix scutellariae and cough-relieving medicine in preparing medicines for treating chronic obstructive pulmonary disease.

CN104383182A (application No. 201410748990.7 Jiangchun flower) discloses a traditional Chinese medicine for treating bronchial asthma, which is characterized by comprising the following raw material medicines in parts by weight: 20-30g of mustard seed, 6-9g of roasted scutellaria baicalensis, 6-9g of ginkgo meat, 6-9g of almond, 6-9g of pinellia ternate, 9-12g of tussilago farfara, 12-15g of cortex mori, 9-12g of scutellaria baicalensis, 9-12g of safflower, 12-15g of fructus aurantii and 6-9g of roasted liquorice.

In addition, there are some documents on the Chinese medicine formula prepared from scutellaria, tabasheer, white mustard seed and other medicinal materials for treating related diseases, for example, CN104623359A (application number: 201510017375.3) discloses a Chinese medicine for treating infantile pneumonia. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 0.9-1.5 g of indigo naturalis, 9-15 g of cortex lycii radicis, 3-9 g of tabasheer, 5-9g of perilla stem, 1.5-9 g of roasted scutellaria baicalensis, 3-9 g of semen brassicae, 3-9 g of scutellaria baicalensis, 3-10 g of dried orange peel, 3-10 g of pinellia ternate, 15-30 g of buffalo horn, 10-25 g of fresh rehmannia root, 3-12 g of uncaria, 6-15 g of raw fructus aurantii, 3-6 g of arisaema cum bile, 9-15 g of kaladana, 3-7.5 g of borneol, 10-25 g of snakegourd seed, 1.5-5 g of coptis chinensis, 6-12 g of burdock, 3-9 g of polygonum cuspidatum root, 12-30 g of tartary buckwheat root, 1.5-9 g of raw liquorice and 12-25 g of paris polyphylla. The traditional Chinese medicine is simple to prepare, good in absorption effect, long in drug effect duration, remarkable in curative effect, free of side effect, high in safety and low in production cost, and is beneficial to timely alleviating symptoms of patients.

CN106039211A (application number: 201610504264.X) relates to a nerve-soothing and convulsion-relieving granule and a preparation method thereof, and the granule is prepared from the following raw materials in parts by weight: 5-15 parts of tabasheer, 5-15 parts of bulbus fritillariae cirrhosae, 6-15 parts of malabaria, 3-9 parts of antelope horn, 5-15 parts of ambergris, 5-15 parts of stiff silkworm, 5-15 parts of rhizoma pinellinae praeparata, 3-9 parts of arisaema cum bile, 3-9 parts of centipede, 7-21 parts of scorpion, 5-15 parts of gastrodia elata, 3-15 parts of radix curcumae, 2-10 parts of alum, 3-15 parts of coptis chinensis, 3-15 parts of magnetite, 5-20 parts of rheum officinale, 5-15 parts of exocarpium citri rubrum, 3-12 parts of gardenia, 3-9 parts of medicated leaven, 3-9 parts of agilawood, 3-12 parts of chlorite, 5-20 parts of poria cocos, 3-12 parts of golden cypress, 3-9 parts of mustard seed, 3-12 parts of scutellaria baicalensis, 3-9 parts of angelica sinensis, 5-15 parts of Chinese date, 2-6 parts of bezoar, 2-6 parts of musk, 5-20 parts of buffalo horn, 3-9 parts of amber and 3-9 parts of honey-fried licorice root. The particles for relieving convulsion are believed to be capable of obviously curing or preventing epilepsy and convulsion diseases, have no toxic or side effect and obvious curative effect, and the contained various traditional Chinese medicine components have mutual synergistic effect, so that the particles not only have the effects of concentrating spirit and improving sleep, but also have the effects of clearing heat and dispelling wind, eliminating phlegm and reducing phlegm and eliminating phlegm for resuscitation, and are beneficial to protecting the health of human bodies.

However, the traditional Chinese medicine formula recorded in the existing literature has complex components, and the effectiveness of some formulas is still to be examined. Therefore, a new method is still expected in the field, particularly a traditional Chinese medicine method is adopted to treat diseases such as lung heat cough, profuse phlegm, wheezing, yellow phlegm, red tongue and yellow fur and the like caused by various reasons, and particularly a traditional Chinese medicine composition capable of clearing lung, eliminating phlegm, relieving cough and relieving asthma for pediatric patients is expected to be provided.

Disclosure of Invention

The invention aims to provide a simple traditional Chinese medicine composition for treating cough with lung heat, profuse phlegm, wheezing, yellow phlegm, red tongue and yellow fur and other symptoms caused by various reasons, the invention also expects to provide a traditional Chinese medicine composition capable of clearing lung heat, eliminating phlegm, relieving cough and relieving asthma for pediatric patients, a method for treating cough with lung heat, profuse phlegm, wheezing, yellow phlegm, red tongue and yellow fur and other symptoms caused by various reasons, and a method for preparing the traditional Chinese medicine composition. It has been surprisingly found that the invention can effectively treat cough with lung heat, profuse phlegm, asthma, yellow phlegm, red tongue with yellow coating and other symptoms caused by various reasons by adopting a relatively simple prescription, and is particularly effectively used for clearing lung heat, eliminating phlegm, relieving cough and relieving asthma for children patients.

Therefore, the invention provides a traditional Chinese medicine composition in a first aspect, which is prepared from the following traditional Chinese medicinal materials and optional pharmaceutical excipients: scutellariae radix, concretio silicea Bambusae seu Schizostachyi, and semen Brassicae Junceae.

The traditional Chinese medicine composition according to the first aspect of the invention is prepared from traditional Chinese medicinal materials in the following proportions: 1 part by weight of scutellaria baicalensis, 0.2-5 parts by weight of tabasheer and 0.05-2 parts by weight of mustard seed.

The traditional Chinese medicine composition according to the first aspect of the invention is prepared from traditional Chinese medicinal materials in the following proportions: 1 part by weight of scutellaria baicalensis, 0.25-2.5 parts by weight of tabasheer and 0.1-1 part by weight of mustard seed.

The traditional Chinese medicine composition according to the first aspect of the invention is prepared from traditional Chinese medicinal materials in the following proportions: 1 part by weight of scutellaria baicalensis, 0.5-2 parts by weight of tabasheer and 0.1-0.5 part by weight of mustard seed.

The traditional Chinese medicine composition according to the first aspect of the invention is prepared from traditional Chinese medicinal materials in the following proportions: 1 part of scutellaria baicalensis, 1 part of tabasheer and 0.15 part of mustard seed.

The Chinese medicinal composition according to the first aspect of the present invention, wherein the Scutellaria baicalensis, SCUTELLARIAE RADIX, is a dried root of Scutellaria baicalensis of the family labiatae, baicailenis Georgi. Collected in spring and autumn, removed fibrous root and silt, dried in the sun, removed the rough skin, and dried in the sun. The scutellaria baicalensis is conical and twisted, and has a length of 8-25 cm and a diameter of 1-3 cm. The surface is brownish yellow or deep yellow, and has sparse warty fine root lines, a rough upper part, twisted longitudinal wrinkles or irregular reticulate patterns, and a smooth line and fine wrinkles at the lower part. Hard and brittle, easy to break, yellow section, reddish brown center; the old root center is in a decayed or hollow shape, dark brown or brownish black. Light smell, bitter taste. The decoction piece scutellaria baicalensis tablet is prepared by the following method: removing impurities, decocting in boiling water for 10 min, taking out, sealing, slicing, and drying; or steaming for half an hour, taking out, slicing, and drying (avoiding exposure to sunlight); is a round-like or irregular sheet, the outer surface is yellow brown or tan, the section is yellow brown or yellow green, and the sheet has radial texture. The decoction piece wine scutellaria baicalensis is prepared by the following method: parching Scutellariae radix slice to dry according to wine roasting method (Chinese pharmacopoeia 2015 edition of the general rules of the four parts 0213); it is shaped like Huang Qin pian with slightly focal spots and slight aroma of wine. The fried scutellaria baicalensis is prepared by the following steps: parching Scutellariae radix tablet with slow fire to slight charred surface, taking out, and cooling. The decoction piece scutellaria baicalensis charcoal is prepared by the following method: parching Scutellariae radix with strong fire until the surface turns brown and the edge is black, storing, spraying clear water, taking out, and sun drying. Baikal skullcap root, radix Scutellariae is bitter in taste and cold in nature; it enters lung, gallbladder, spleen, large intestine and small intestine meridians; has the effects of clearing heat, eliminating dampness, purging pathogenic fire, removing toxic substances, stopping bleeding, and preventing miscarriage; can be used for treating damp-warm syndrome, summer-heat dampness, chest distress, emesis, dampness and heat distention, dysentery, jaundice, cough due to lung heat, hyperpyrexia, polydipsia, hematemesis, carbuncle, swelling, sore, and threatened abortion. According to the invention, the scutellaria can be scutellaria medicinal materials, and can also be prepared into slices, wine-processed scutellaria, fried scutellaria and charred scutellaria. The various scutellaria baicalensis and various decoction pieces thereof can be commonly used in the invention, and the chemical substances and physiological effects of the scutellaria baicalensis and the decoction pieces thereof are not different essentially. In the specific examples below, the scutellaria baicalensis used is scutellaria baicalensis tablet, as not specifically indicated.

The Chinese medicinal composition according to the first aspect of the present invention, wherein the tabasheer, BAMBUSAE concrete siicea, is a dried cake of exudates from culms of Bambusa textilis McClure, or Schizostachyum chinense Rendle, which are plants of the family gramineae. Collected in autumn and winter. Concretio silicea Bambusae seu Schizostachyi is irregular tablet or granule with different sizes. The surface is grayish blue, grayish yellow or grayish white, and the surface is clean white, semitransparent and slightly glossy. Light weight, hard and brittle, easy to break and strong in hygroscopicity. Light smell, bland taste. The concretio silicea Bambusae seu Schizostachyi is sweet in taste and cold in nature; heart and liver meridian entered; has effects of clearing heat, eliminating phlegm, cooling heart and arresting convulsion; can be used for treating fever unconsciousness, apoplexy with phlegm, infantile convulsion due to phlegm-heat, convulsion, and night cry. According to the invention, the concretio silicea bambusae may be concretio silicea bambusae of various bamboo sources. Concretio silicea bambusae from various sources can be commonly used in the invention, and the chemical substances and physiological effects of the concretio silicea bambusae are not different essentially. In the following specific examples, concretio silicea bambusae used is of green-bark bamboo origin, unless specified otherwise.

The Chinese medicinal composition according to the first aspect of the present invention wherein the mustard, SINAPIS SEMEN, is dried mature seed of the crucifer mustard Sinapis alba L. or the mustard Brassica juncea (L.) czern.et coss. The former is commonly called "white mustard seed", and the latter is commonly called "yellow mustard seed". Harvesting plants when the fruits are mature in late summer and early autumn, drying in the sun, seeding, and removing impurities. The white mustard seeds are spherical and have the diameter of 1.5-2.5 mm. The surface is gray to light yellow, has fine reticulate pattern and obvious punctate umbilicus. The seed coat is thin and crisp, and white folded cotyledon is in the seed coat after the seed coat is broken, and the seed coat is oily. Light smell, pungent and spicy taste. The yellow mustard seeds are small and have the diameter of 1-2 mm. The surface was yellow to tan and a few dark reddish brown. After grinding, the mixture is soaked in water to generate a special pungent odor. The decoction piece mustard is prepared by the following steps: removing impurities, and mashing. The stir-fried mustard slices are prepared by the following steps: parching semen Sinapis Albae to light yellow to dark yellow (parched semen Sinapis Albae) or dark yellow to brown (parched semen Sinapis Albae) with spicy smell according to parching method (the four parts of pharmacopoeia 2015 edition general rule 0213); mashing; the stir-fried mustard is like mustard, and has a surface from light yellow to dark yellow (stir-fried white mustard) or dark yellow to dark brown (stir-fried yellow mustard), and occasionally has a focal spot. Has spicy flavor. Mustard seed, pungent in flavor and warm in nature, enters lung meridian; has effects of warming lung, eliminating phlegm, activating qi-flowing, resolving hard mass, dredging collaterals and relieving pain; can be used for treating cough due to cold phlegm, distending pain in chest and hypochondrium, phlegm stagnation, meridian obstruction, numbness of joints, pain, phlegm dampness, multiple abscess, and cellulitis. According to the invention, the mustard can be mustard of various sources, namely white mustard or yellow mustard. According to the invention, the mustard can be a mustard medicinal material, and can also be a piece of mustard or a piece of mustard fried by pieces. Mustard from various sources and their various pieces can be used universally in the present invention, with essentially no difference in their chemical and physiological roles. In the specific examples below, the mustard used is white mustard, as not specifically indicated.

The traditional Chinese medicine composition according to the first aspect of the invention, wherein the scutellaria baicalensis is added to the composition in the form of medicinal material powder, or in the form of an extract thereof, or in the form of an extract obtained by extracting the scutellaria baicalensis with other medicinal material(s).

The traditional Chinese medicine composition according to the first aspect of the invention, wherein the concretio silicea bambusae is added to the composition in the form of powder of medicinal materials, or in the form of an extract thereof, or in the form of an extract obtained by extracting the concretio silicea bambusae with other medicinal material(s).

The Chinese medicinal composition according to the first aspect of the invention, wherein the mustard is added to the composition in the form of powder of the medicinal materials, or in the form of an extract thereof, or in the form of an extract obtained by extracting the mustard together with one or more other medicinal materials.

The traditional Chinese medicine composition according to the first aspect of the invention, wherein the medicinal material powder is a powder capable of passing through at least 80 mesh sieve, or a powder capable of passing through at least 100 mesh sieve, or a powder capable of passing through at least 120 mesh sieve. It is well known that medicinal materials can be processed into powders by, for example, but not limited to, pulverization, grinding, and combinations thereof.

The Chinese medicinal composition according to the first aspect of the present invention, wherein the extract, whether the extract of a single herb or the extract obtained by extracting a plurality of herbs together, may be extracted with a solvent selected from the group consisting of: water, ethanol, and ethanol aqueous solution such as 10-90% ethanol.

The Chinese medicinal composition according to the first aspect of the present invention, wherein the extraction may be any extraction method or combination thereof well known in the pharmaceutical field, such as but not limited to: maceration, decoction, percolation, etc., and the solvent is preferably removed after extraction.

The Chinese medicinal composition according to the first aspect of the present invention, wherein the powder may optionally be combined with liquid or semi-solid excipients, for example, water, ethanol such as yellow wine, acetic acid such as vinegar, aqueous solutions thereof, and the like to form a paste for external use.

The traditional Chinese medicine composition according to the first aspect of the invention is an external preparation. In one embodiment, the external preparation is in the form of a patch, ointment, cream, or the like. In one embodiment, the external preparation is prepared by mixing powder of the medicinal materials and liquid or semisolid auxiliary materials into paste (for example, the weight ratio of the medicinal powder to the liquid auxiliary materials is 1-5: 1). The paste preparation is used, smeared or pasted on the skin, and further exerts the drug effect.

The traditional Chinese medicine composition according to the first aspect of the invention is an oral preparation. In one embodiment, the oral formulation is in the form of granules, tablets, capsules, oral liquids, granules, pills, sprays, and the like. These dosage forms are conveniently administered orally.

The traditional Chinese medicine composition according to the first aspect of the invention is an external preparation or an oral preparation, and is prepared according to the following steps: pulverizing the above materials into fine powder, or extracting the above materials separately or in any combination to obtain extract, and making into external preparation or oral preparation by use of preparation process, wherein medicinal adjuvants are optionally added.

Further, the second aspect of the present invention provides a method for preparing a Chinese medicinal composition, which is an external preparation or an oral preparation, comprising the steps of: pulverizing Scutellariae radix, concretio silicea Bambusae seu Schizostachyi, and semen Brassicae Junceae into fine powder, or extracting each medicinal material separately or optionally to obtain extract, and preparing the obtained fine powder or extract into external preparation or oral preparation by preparation process, optionally adding medicinal adjuvants.

According to the method of the second aspect of the invention, the proportion of the Chinese medicinal materials is as follows: 1 part by weight of scutellaria baicalensis, 0.2-5 parts by weight of tabasheer and 0.05-2 parts by weight of mustard seed.

According to the method of the second aspect of the invention, the proportion of the Chinese medicinal materials is as follows: 1 part by weight of scutellaria baicalensis, 0.25-2.5 parts by weight of tabasheer and 0.1-1 part by weight of mustard seed.

According to the method of the second aspect of the invention, the proportion of the Chinese medicinal materials is as follows: 1 part by weight of scutellaria baicalensis, 0.5-2 parts by weight of tabasheer and 0.1-0.5 part by weight of mustard seed.

According to the method of the second aspect of the invention, the proportion of the Chinese medicinal materials is as follows: 1 part of scutellaria baicalensis, 1 part of tabasheer and 0.15 part of mustard seed.

The process according to the second aspect of the present invention, wherein said Scutellaria baicalensis, SCUTELLARIAE RADIX, is a dried root of Scutellaria baicalensis of the family labiatae, Scutellaria baicalensis Georgi. Collected in spring and autumn, removed fibrous root and silt, dried in the sun, removed the rough skin, and dried in the sun. The scutellaria baicalensis is conical and twisted, and has a length of 8-25 cm and a diameter of 1-3 cm. The surface is brownish yellow or deep yellow, and has sparse warty fine root lines, a rough upper part, twisted longitudinal wrinkles or irregular reticulate patterns, and a smooth line and fine wrinkles at the lower part. Hard and brittle, easy to break, yellow section, reddish brown center; the old root center is in a decayed or hollow shape, dark brown or brownish black. Light smell, bitter taste. The decoction piece scutellaria baicalensis tablet is prepared by the following method: removing impurities, decocting in boiling water for 10 min, taking out, sealing, slicing, and drying; or steaming for half an hour, taking out, slicing, and drying (avoiding exposure to sunlight); is a round-like or irregular sheet, the outer surface is yellow brown or tan, the section is yellow brown or yellow green, and the sheet has radial texture. The decoction piece wine scutellaria baicalensis is prepared by the following method: parching Scutellariae radix slice to dry according to wine roasting method (Chinese pharmacopoeia 2015 edition of the general rules of the four parts 0213); it is shaped like Huang Qin pian with slightly focal spots and slight aroma of wine. Baikal skullcap root, radix Scutellariae is bitter in taste and cold in nature; it enters lung, gallbladder, spleen, large intestine and small intestine meridians; has the effects of clearing heat, eliminating dampness, purging pathogenic fire, removing toxic substances, stopping bleeding, and preventing miscarriage; can be used for treating damp-warm syndrome, summer-heat dampness, chest distress, emesis, dampness and heat distention, dysentery, jaundice, cough due to lung heat, hyperpyrexia, polydipsia, hematemesis, carbuncle, swelling, sore, and threatened abortion. According to the invention, the scutellaria can be a scutellaria medicinal material, and can also be a decoction piece scutellaria tablet or wine scutellaria. The various scutellaria baicalensis and various decoction pieces thereof can be commonly used in the invention, and the chemical substances and physiological effects of the scutellaria baicalensis and the decoction pieces thereof are not different essentially.

The method according to the second aspect of the present invention, wherein the tabasheer, BAMBUSAE concrete siicea, is a dried mass of the exudate from culms of the gramineous plant, Bambusa textilis McClure or Schizostachyum chinense Rendle. Collected in autumn and winter. Concretio silicea Bambusae seu Schizostachyi is irregular tablet or granule with different sizes. The surface is grayish blue, grayish yellow or grayish white, and the surface is clean white, semitransparent and slightly glossy. Light weight, hard and brittle, easy to break and strong in hygroscopicity. Light smell, bland taste. The concretio silicea Bambusae seu Schizostachyi is sweet in taste and cold in nature; heart and liver meridian entered; has effects of clearing heat, eliminating phlegm, cooling heart and arresting convulsion; can be used for treating fever unconsciousness, apoplexy with phlegm, infantile convulsion due to phlegm-heat, convulsion, and night cry. According to the invention, the concretio silicea bambusae may be concretio silicea bambusae of various bamboo sources. Concretio silicea bambusae from various sources can be commonly used in the invention, and the chemical substances and physiological effects of the concretio silicea bambusae are not different essentially.

The method according to the second aspect of the invention wherein the mustard, SINAPIS SEMEN, is a dried mature seed of the crucifer mustard Sinapis alba L. The former is commonly called "white mustard seed", and the latter is commonly called "yellow mustard seed". Harvesting plants when the fruits are mature in late summer and early autumn, drying in the sun, seeding, and removing impurities. The white mustard seeds are spherical and have the diameter of 1.5-2.5 mm. The surface is gray to light yellow, has fine reticulate pattern and obvious punctate umbilicus. The seed coat is thin and crisp, and white folded cotyledon is in the seed coat after the seed coat is broken, and the seed coat is oily. Light smell, pungent and spicy taste. The yellow mustard seeds are small and have the diameter of 1-2 mm. The surface was yellow to tan and a few dark reddish brown. After grinding, the mixture is soaked in water to generate a special pungent odor. The decoction piece mustard is prepared by the following steps: removing impurities, and mashing. The stir-fried mustard slices are prepared by the following steps: parching semen Sinapis Albae to light yellow to dark yellow (parched semen Sinapis Albae) or dark yellow to brown (parched semen Sinapis Albae) with spicy smell according to parching method (the four parts of pharmacopoeia 2015 edition general rule 0213); mashing; the stir-fried mustard is like mustard, and has a surface from light yellow to dark yellow (stir-fried white mustard) or dark yellow to dark brown (stir-fried yellow mustard), and occasionally has a focal spot. Has spicy flavor. Mustard seed, pungent in flavor and warm in nature, enters lung meridian; has effects of warming lung, eliminating phlegm, activating qi-flowing, resolving hard mass, dredging collaterals and relieving pain; can be used for treating cough due to cold phlegm, distending pain in chest and hypochondrium, phlegm stagnation, meridian obstruction, numbness of joints, pain, phlegm dampness, multiple abscess, and cellulitis. According to the invention, the mustard can be mustard of various sources, namely white mustard or yellow mustard. According to the invention, the mustard can be a mustard medicinal material, and can also be a piece of mustard or a piece of mustard fried by pieces. Mustard from various sources and their various pieces can be used universally in the present invention, with essentially no difference in their chemical and physiological roles.

The method according to the second aspect of the present invention, wherein the scutellaria baicalensis is added to the composition in the form of a medicinal material powder, or in the form of an extract thereof extracted together with other one or more medicinal materials.

The method according to the second aspect of the invention, wherein the concretio silicea bambusae is added to the composition in the form of powder of medicinal materials, or in the form of an extract thereof extracted together with one or more other medicinal materials.

According to the second aspect of the invention, the mustard is added to the composition in the form of a powder of the medicinal material, or in the form of an extract thereof extracted together with one or more other medicinal materials.

The method according to the second aspect of the present invention, wherein the medicinal material powder is a powder capable of passing through at least 80 mesh, or a powder capable of passing through at least 100 mesh, or a powder capable of passing through at least 120 mesh. It is well known that medicinal materials can be processed into powders by, for example, but not limited to, pulverization, grinding, and combinations thereof.

According to the method of the second aspect of the present invention, wherein the extract, whether the extract of a single herb or the extract obtained by extracting a plurality of herbs together, is extracted with a solvent selected from the group consisting of: water, ethanol, and ethanol aqueous solution such as 10-90% ethanol.

The method according to the second aspect of the present invention, wherein the extraction may be any extraction means or combination thereof well known in the pharmaceutical art, such as, but not limited to: maceration, decoction, percolation, etc., and the solvent is preferably removed after extraction.

The method according to the second aspect of the invention, wherein the powder may optionally be combined with liquid or semi-solid excipients, for example water, ethanol, such as yellow wine, acetic acid, such as vinegar, aqueous solutions thereof, and the like, to form a paste for external use.

The method according to the second aspect of the present invention, wherein the Chinese medicinal composition is an external preparation. In one embodiment, the external preparation is in the form of a patch, ointment, cream, or the like. In one embodiment, the external preparation is prepared by mixing powder of the medicinal materials and liquid or semisolid auxiliary materials into paste (for example, the weight ratio of the medicinal powder to the liquid auxiliary materials is 1-5: 1). The paste preparation is used, smeared or pasted on the skin, and further exerts the drug effect.

The method according to the second aspect of the present invention, wherein the Chinese medicinal composition is an oral preparation. In one embodiment, the oral formulation is in the form of granules, tablets, capsules, oral liquids, granules, pills, sprays, and the like. These dosage forms are conveniently administered orally.

The method according to the second aspect of the present invention, wherein the Chinese medicinal composition is an external preparation or an oral preparation, which is prepared according to the steps comprising: pulverizing the above materials into fine powder, or extracting the above materials separately or in any combination to obtain extract, and making into external preparation or oral preparation by use of preparation process, wherein medicinal adjuvants are optionally added.

Further, the third aspect of the invention provides an application of a combination of the following traditional Chinese medicinal materials in preparing a medicament for clearing lung heat, eliminating phlegm, relieving cough and asthma, or an application in preparing a medicament for treating lung heat cough, profuse phlegm, wheezing, yellow phlegm, red tongue and yellow fur: scutellariae radix, concretio silicea Bambusae seu Schizostachyi, and semen Brassicae Junceae.

According to the application of the third aspect of the invention, the medicine is used for clearing lung heat, eliminating phlegm, relieving cough and asthma of the pediatric patients or is used for treating cough due to lung heat, profuse phlegm, wheezing, yellow phlegm, red tongue and yellow fur of the pediatric patients.

The use according to the third aspect of the invention, wherein the medicament is prepared from the following Chinese medicinal materials in proportion: 1 part by weight of scutellaria baicalensis, 0.2-5 parts by weight of tabasheer and 0.05-2 parts by weight of mustard seed.

The use according to the third aspect of the invention, wherein the medicament is prepared from the following Chinese medicinal materials in proportion: 1 part by weight of scutellaria baicalensis, 0.25-2.5 parts by weight of tabasheer and 0.1-1 part by weight of mustard seed.

The use according to the third aspect of the invention, wherein the medicament is prepared from the following Chinese medicinal materials in proportion: 1 part by weight of scutellaria baicalensis, 0.5-2 parts by weight of tabasheer and 0.1-0.5 part by weight of mustard seed.

The use according to the third aspect of the invention, wherein the medicament is prepared from the following Chinese medicinal materials in proportion: 1 part of scutellaria baicalensis, 1 part of tabasheer and 0.15 part of mustard seed.

The use according to the third aspect of the present invention, wherein said Scutellaria baicalensis, SCUTELLARIAE RADIX, is a dried root of Scutellaria baicalensis of the family labiatae, baicailes baicalensis Georgi. Collected in spring and autumn, removed fibrous root and silt, dried in the sun, removed the rough skin, and dried in the sun. The scutellaria baicalensis is conical and twisted, and has a length of 8-25 cm and a diameter of 1-3 cm. The surface is brownish yellow or deep yellow, and has sparse warty fine root lines, a rough upper part, twisted longitudinal wrinkles or irregular reticulate patterns, and a smooth line and fine wrinkles at the lower part. Hard and brittle, easy to break, yellow section, reddish brown center; the old root center is in a decayed or hollow shape, dark brown or brownish black. Light smell, bitter taste. The decoction piece scutellaria baicalensis tablet is prepared by the following method: removing impurities, decocting in boiling water for 10 min, taking out, sealing, slicing, and drying; or steaming for half an hour, taking out, slicing, and drying (avoiding exposure to sunlight); is a round-like or irregular sheet, the outer surface is yellow brown or tan, the section is yellow brown or yellow green, and the sheet has radial texture. The decoction piece wine scutellaria baicalensis is prepared by the following method: parching Scutellariae radix slice to dry according to wine roasting method (Chinese pharmacopoeia 2015 edition of the general rules of the four parts 0213); it is shaped like Huang Qin pian with slightly focal spots and slight aroma of wine. Baikal skullcap root, radix Scutellariae is bitter in taste and cold in nature; it enters lung, gallbladder, spleen, large intestine and small intestine meridians; has the effects of clearing heat, eliminating dampness, purging pathogenic fire, removing toxic substances, stopping bleeding, and preventing miscarriage; can be used for treating damp-warm syndrome, summer-heat dampness, chest distress, emesis, dampness and heat distention, dysentery, jaundice, cough due to lung heat, hyperpyrexia, polydipsia, hematemesis, carbuncle, swelling, sore, and threatened abortion. According to the invention, the scutellaria can be a scutellaria medicinal material, and can also be a decoction piece scutellaria tablet or wine scutellaria. The various scutellaria baicalensis and various decoction pieces thereof can be commonly used in the invention, and the chemical substances and physiological effects of the scutellaria baicalensis and the decoction pieces thereof are not different essentially.

The use according to the third aspect of the present invention, wherein said tabasheer, BAMBUSAE concrete siicea, is a dried mass of exudates from stalks of the grass family, Bambusa textilis McClure or Schizostachyum chinense Rendle. Collected in autumn and winter. Concretio silicea Bambusae seu Schizostachyi is irregular tablet or granule with different sizes. The surface is grayish blue, grayish yellow or grayish white, and the surface is clean white, semitransparent and slightly glossy. Light weight, hard and brittle, easy to break and strong in hygroscopicity. Light smell, bland taste. The concretio silicea Bambusae seu Schizostachyi is sweet in taste and cold in nature; heart and liver meridian entered; has effects of clearing heat, eliminating phlegm, cooling heart and arresting convulsion; can be used for treating fever unconsciousness, apoplexy with phlegm, infantile convulsion due to phlegm-heat, convulsion, and night cry. According to the invention, the concretio silicea bambusae may be concretio silicea bambusae of various bamboo sources. Concretio silicea bambusae from various sources can be commonly used in the invention, and the chemical substances and physiological effects of the concretio silicea bambusae are not different essentially.

The use according to the third aspect of the invention wherein the mustard, SINAPIS SEMEN, is dried mature seed of the crucifer mustard Sinapis alba L. The former is commonly called "white mustard seed", and the latter is commonly called "yellow mustard seed". Harvesting plants when the fruits are mature in late summer and early autumn, drying in the sun, seeding, and removing impurities. The white mustard seeds are spherical and have the diameter of 1.5-2.5 mm. The surface is gray to light yellow, has fine reticulate pattern and obvious punctate umbilicus. The seed coat is thin and crisp, and white folded cotyledon is in the seed coat after the seed coat is broken, and the seed coat is oily. Light smell, pungent and spicy taste. The yellow mustard seeds are small and have the diameter of 1-2 mm. The surface was yellow to tan and a few dark reddish brown. After grinding, the mixture is soaked in water to generate a special pungent odor. The decoction piece mustard is prepared by the following steps: removing impurities, and mashing. The stir-fried mustard slices are prepared by the following steps: parching semen Sinapis Albae to light yellow to dark yellow (parched semen Sinapis Albae) or dark yellow to brown (parched semen Sinapis Albae) with spicy smell according to parching method (the four parts of pharmacopoeia 2015 edition general rule 0213); mashing; the stir-fried mustard is like mustard, and has a surface from light yellow to dark yellow (stir-fried white mustard) or dark yellow to dark brown (stir-fried yellow mustard), and occasionally has a focal spot. Has spicy flavor. Mustard seed, pungent in flavor and warm in nature, enters lung meridian; has effects of warming lung, eliminating phlegm, activating qi-flowing, resolving hard mass, dredging collaterals and relieving pain; can be used for treating cough due to cold phlegm, distending pain in chest and hypochondrium, phlegm stagnation, meridian obstruction, numbness of joints, pain, phlegm dampness, multiple abscess, and cellulitis. According to the invention, the mustard can be mustard of various sources, namely white mustard or yellow mustard. According to the invention, the mustard can be a mustard medicinal material, and can also be a piece of mustard or a piece of mustard fried by pieces. Mustard from various sources and their various pieces can be used universally in the present invention, with essentially no difference in their chemical and physiological roles.

The use according to the third aspect of the present invention, wherein said scutellaria baicalensis is added to said composition in the form of a powder of the medicinal material, or in the form of an extract thereof obtained by extracting it with another medicinal material or materials.

The use according to the third aspect of the invention, wherein the concretio silicea bambusae is added to the composition in the form of a powder of the medicinal material, or in the form of an extract thereof extracted together with one or more other medicinal materials.

The use according to the third aspect of the invention, wherein the mustard is added to the composition in the form of a powder of the medicinal material, or in the form of an extract thereof extracted with one or more other medicinal materials.

The use according to the third aspect of the present invention, wherein the medicinal material powder is a powder capable of passing through at least 80 mesh, or a powder capable of passing through at least 100 mesh, or a powder capable of passing through at least 120 mesh. It is well known that medicinal materials can be processed into powders by, for example, but not limited to, pulverization, grinding, and combinations thereof.

According to the third aspect of the present invention, wherein the extract, whether the extract of a single herb or the extract obtained by extracting a plurality of herbs together, is extracted with a solvent selected from the group consisting of: water, ethanol, and ethanol aqueous solution such as 10-90% ethanol.

The use according to the third aspect of the invention, wherein the extraction may be any extraction means or combination thereof well known in the pharmaceutical art, such as, but not limited to: maceration, decoction, percolation, etc., and the solvent is preferably removed after extraction.

The use according to the third aspect of the invention, wherein the powder may optionally be combined with liquid or semi-solid excipients, for example water, ethanol, such as yellow wine, acetic acid, such as vinegar, aqueous solutions thereof, and the like, to form a paste for external use.

The use according to the third aspect of the present invention, wherein the medicament is an external preparation. In one embodiment, the external preparation is in the form of a patch, ointment, cream, or the like. In one embodiment, the external preparation is prepared by mixing powder of the medicinal materials and liquid or semisolid auxiliary materials into paste (for example, the weight ratio of the medicinal powder to the liquid auxiliary materials is 1-5: 1). The paste preparation is used, smeared or pasted on the skin, and further exerts the drug effect.

The use according to the third aspect of the invention, wherein the medicament is an oral formulation. In one embodiment, the oral formulation is in the form of granules, tablets, capsules, oral liquids, granules, pills, sprays, and the like. These dosage forms are conveniently administered orally.

The use according to the third aspect of the present invention, wherein the medicament is an external preparation or an oral preparation, which is prepared by the steps comprising: pulverizing the above materials into fine powder, or extracting the above materials separately or in any combination to obtain extract, and making into external preparation or oral preparation by use of preparation process, wherein medicinal adjuvants are optionally added.

Further, the present invention provides a method for detecting the quality of the composition according to any one of the first aspect of the present invention, which comprises measuring the content of sinapine thiocyanate in the composition by high performance liquid chromatography, comprising the following steps:

according to the standard of high performance liquid chromatography carried in section 0512 of the general rules of the four parts of the pharmacopoeia of the people's republic of China of 2015 version;

chromatographic conditions and system applicability test: octadecylsilane chemically bonded silica is used as a filling agent; acetonitrile-0.08 mol/L potassium dihydrogen phosphate solution is added into the mixture according to the volume ratio of 10: 90 is a mobile phase; the detection wavelength is 326 mn; the number of theoretical plates is not less than 3000 calculated according to sinapine peak;

preparation of control solutions: accurately weighing appropriate amount of sinapine thiocyanate control, and adding mobile phase to obtain solution containing 0.2mg per 1 ml;

preparation of a test solution: taking a sample corresponding to 1g of mustard seed medicinal material, precisely weighing, placing in a conical flask with a plug, adding 50ml of methanol, carrying out ultrasonic treatment for 20 minutes at the power of 250W and the frequency of 20kHz, filtering, extracting filter residues for three times by using the same method with the methanol, and combining filtrates; recovering solvent under reduced pressure, dissolving the residue with mobile phase, transferring to 50ml measuring flask, diluting with mobile phase to scale, shaking, filtering, and collecting filtrate;

the determination method comprises the following steps: precisely sucking 10 μ l of each of the reference solution and the sample solution, injecting into a liquid chromatograph, measuring, and calculating the content of sinapine thiocyanate, i.e. C16H24NO 5. SCN, in the sample by peak area according to an external standard method.

The method according to the fourth aspect of the present invention, wherein the preparation of the test solution is carried out as follows: taking a sample corresponding to 1g of mustard seed medicinal material, precisely weighing, placing in a conical flask with a plug, adding 50ml of methanol, 100mg of calcium chloride and 20 mul of glacial acetic acid, carrying out ultrasonic treatment for 20 minutes at the power of 250W and the frequency of 20kHz, filtering, extracting filter residues for three times by using the same method with methanol, and combining filtrates; recovering solvent under reduced pressure, dissolving the residue with mobile phase, transferring to 50ml measuring flask, diluting with mobile phase to scale, shaking, filtering, and collecting the filtrate. It has been found that, probably due to the presence of scutellaria in the recipe, the content is significantly lower than the theoretical amount when the sinapine thiocyanate in the composition is determined using conventional methods; surprisingly, the above problems can be effectively overcome by adding small amounts of calcium chloride and glacial acetic acid when preparing the test solution.

In the above-described steps of the preparation method of the present invention, although the specific steps described therein are distinguished in some detail or in language description from the steps described in the preparation examples of the detailed embodiments below, those skilled in the art can fully summarize the above-described method steps in light of the detailed disclosure throughout the present disclosure.

Any embodiment of any aspect of the invention may be combined with other embodiments, as long as they do not contradict. Furthermore, in any embodiment of any aspect of the invention, any feature may be applicable to that feature in other embodiments, so long as they do not contradict. The invention is further described below.

All documents cited herein are incorporated by reference in their entirety and to the extent such documents do not conform to the meaning of the present invention, the present invention shall control. Further, the various terms and phrases used herein have the ordinary meaning as is known to those skilled in the art, and even though such terms and phrases are intended to be described or explained in greater detail herein, reference is made to the term and phrase as being inconsistent with the known meaning and meaning as is accorded to such meaning throughout this disclosure.

Baikal skullcap root is a herbal medicine recorded in Chinese pharmacopoeia, is named as Qin, is a Qin grass and has a common name of Baikal skullcap root due to yellow grass. The Chinese character of Qin is 'hemostatic grass'. Is also named as camellia root and native gold tea root. Baikal skullcap root is used as the drug. Produced in Hebei, Liaoning, Shaanxi, Shandong, inner Mongolia and Heilongjiang. Baikal skullcap root, radix Scutellariae is bitter in taste and cold in nature; it enters lung meridian, heart meridian, liver meridian, gallbladder meridian and large intestine meridian. Scutellariae radix has effects of purging pathogenic fire, removing toxic substances, stopping bleeding, clearing heat, eliminating dampness, and preventing miscarriage; can be used for treating damp-warm syndrome, jaundice, cough due to lung heat, hyperpyrexia, polydipsia, blood heat, hematemesis, summer-heat syndrome, chest distress, emesis, damp-heat distention, dysentery, carbuncle, swelling, suppurative sore, threatened abortion, fever, coma, headache due to liver fire, conjunctival congestion, swelling and pain, jaundice due to damp-heat, dysentery, heat stranguria, hematemesis, metrorrhagia, threatened abortion, carbuncle, furuncle, etc.

The pharmacological actions of scutellaria are mainly as follows. 1. The antibacterial effect is as follows: the Scutellariae radix decoction has 100% concentration, and has inhibitory effect on dysentery bacillus, typhoid bacillus, paratyphoid bacillus, cholera vibrio, Escherichia coli, proteus bacillus, Pseudomonas aeruginosa, staphylococcus, hemolytic streptococcus (a, B), Diplococcus pneumoniae, and diphtheria bacillus. Scutellaria decoction test tube test 1: 1280 the concentration can inhibit the growth of typhoid bacillus, hemolytic streptococcus a, 1: 640 concentration inhibits hemolytic streptococcus B, diplococcus pneumoniae, shigella flexneri, and mycobacterium tuberculosis H37, 1: 320 concentration can inhibit Vibrio cholerae and Shigella shigelloides; 1: the Shigella sonnei can inhibit at 80% (v/v). 0.5g/ml or 0.05g/ml of scutellaria baicalensis alcohol immersion liquid is cultured by agar slant, and the liquid medicine is mixed with a culture medium 1: 1 has inhibiting effect on Pseudomonas aeruginosa. The Scutellariae radix ethanol extractive solution has concentration of 2g/ml, and has inhibiting effect on Escherichia coli, Bacillus citrinopileatus, and Staphylococcus aureus by plate test. The concentration of the scutellaria decoction and the alcohol extract is 1g/ml, and the test by a plate method has an inhibiting effect on meningococcus. 2. Antifungal action: in the scutellaria decoction, the test tube slant method tests show that 4% of the concentration can inhibit Microchaeta canis and Trichophyton violaceum, 8% of the concentration can inhibit Trichophyton schoenleinii, 10% of the concentration can inhibit Mongolian variety of Trichophyton schoenleinii, and 15% of the concentration can inhibit Trichophyton mentagrophytes and Trichophyton ferrugineum. Scutellaria aqueous infusion 1: 3 has different degrees of bacteriostasis on trichophyton violaceum, trichophyton concentricum, trichophyton schoenleinii, trichophyton audoli, trichophyton lanuginosi, trichophyton rubrum, K, W, trichophyton surimi, nocardia stellata and the like in test tubes. 3. The antiviral effect is as follows: the Scutellariae radix decoction has 25-100% concentration, and has effect in inhibiting hepatitis B virus DNA replication in vitro test. 4. Anti-inflammatory and anti-allergic reactions: 200mg/kg of scutellaria 70% ethanol extract, 500mg/kg of gavage baicalein, baicalin and wogonin 50mg/kg of wogonin and 100mg/kg of gavage can inhibit the increase of abdominal cavity exudation of mice caused by acetic acid and inhibit the foot swelling of rats caused by 48/80 (a compound name, produced by Sigma), and 500mg/kg of scutellaria 70% ethanol extract and 100mg/kg of baicalin, baicalin and wogonin can inhibit adjuvant arthritis of rats. The scutellaria baicalensis aqueous extract 100mg/kg is used for gastric perfusion, has an inhibition effect on passive skin anaphylaxis (PCA) of rats, but has no obvious effect on contact dermatitis (ear swelling) of mice caused by chloropicrin. The effective components of Scutellariae radix for inhibiting passive skin anaphylaxis (PCA) are baicalin and baicalein. Baicalin and baicalein are effective in experimental asthma, and baicalin 10-4g/ml can inhibit Schultz-Dale reaction of guinea pig trachea, and has antihistaminic, anticholinergic and papaverine-like effects. Baicalein is insoluble in water, and two water-soluble derivatives of baicalein-6-disodium phosphate (BPS) and baicalein-6-disodium sulfate (BSS) are injected intravenously at 5mg/kg before antigen attack, and have inhibitory effect on rat PCA; the 10mg/kg intravenous injection is administered 10 minutes before antigen challenge, and has inhibitory effect on allergic asthma of guinea pig; BPS and BSS have inhibition effect on isolated guinea pig intestinal canal and trachea chultz-Dale reaction at the concentration of 10-4 g/ml; BPS and BSS5mg/kg intravenous injection have inhibitory effect on rat reverse skin anaphylaxis (RCA); intravenous injection of 5-10mg/kg also inhibited Forssman cutaneous vasculitis, but had no significant effect on Arthus response. Baicalein and BPS are structurally similar to an antiallergic drug disodium cromoglycate (DSCG), but the DSCG is a two-color ketone, the baicalein and the BPS are single-color ketones, the DSCG has high specificity to the allergic reaction mediated by a reactin (reactive) antibody, but has little effect on the allergic reaction mediated by a non-reactin (IgG) antibody, PBS not only inhibits the allergic reaction mediated by the reactin antibody, such as PBS10-6-10-4g/ml inhibits monkey lung medium release caused by antigen, PBS 200mg/kg intraperitoneal injection inhibits rat homogeneous PCA, 10-4g/ml inhibits rat mast cell degranulation and the like mediated by the reactin antibody, but also inhibits the reaction mediated by the non-reactin antibody, such as BPS10-4g/ml can inhibit ovalbumin sensitized guinea pig lung release medium and inhibit human lung release allergic medium caused by anti-IgE antibody, and a certain distance is considered between two chromone cores in DSCG molecules, can bind to the functional site of the reactive antibody and is not suitable for the non-reactive antibody, but the baicalein or BPS of the monochromatic ketone can bind to the two antibodies by two molecules. Baicalein has inhibitory effect on both cyclooxygenase and lipoxygenase in rat platelet arachidonic acid metabolism, and has selectivity on lipoxygenase, IC50 is 0.12 μm, and IC50 is 6917 times of lipoxygenase. Baicalein can inhibit arachidonic acid metabolism and inhibit the generation of lipoxygenase metabolite 5-hydroxyeicosatetraenoic acid (5-HETE) and cyclooxygenase metabolite 12-hydroxyheptadecatrienoic acid (HHT) on rat leucocytes, and has IC50 of 7.13 + -0.767 μm and 5.53 + -16.9 μm respectively; baicalin also inhibits leukocyte 5-HETE formation, but does not inhibit HHT formation; wogonin inhibits HHT formation, IC50 is 14.6 + -3.51 μm inhibitory effect of Scutellaria baicalensis Georgi component on the stimulation of histamine release from rat peritoneal mast cells by compound 48/80, IC50 is 52.1 μm for baicalein, IC50 is > 200 μm for baicalin, IC50 is 40.0 μm for woogonin, IC50 is 140.0mol/l for wogonin-7-O-D glucuronic acid, (IC 50 is 17.7 μm for (25)2', 5, 6', 7-tetrahydroxyflavanone, (2R,3R) -2', 3,5, 6', 7-tetrahydroxyflavanone IC50 is 15.5 μm, IC50 is > 200 μm for Chrysin (Chrysin), IC50 is 15.0 μm for wogonin II (Skulpapflug II). Baicalin 10, 100mg/ml, has obvious inhibition effect on PGE2 and TXA2 produced by rat abdominal cavity macrophage induced by calcium ionophore A23187. 5. Effects on the central nervous system: the scutellaria decoction is injected into the abdominal cavity at 4g/kg, which can prolong the time of positive reflex on defensive conditioned reflex of mice, but has no influence on unconditional reflex and differentiation, thus indicating that the scutellaria can strengthen the cortical inhibition process. The scutellaria decoction is 2g/kg, and has the antipyretic effect on the typhoid fever-induced rabbits of the mixed vaccine. However, it has been reported that 5-9 g/one of the water decoction or the wine infusion of scutellaria baicalensis is infused into the stomach, or 2 g/one of im cannot prove that the scutellaria baicalensis has the antipyretic effect on the febrile vaccine fever rabbits. 6. Effect on cardiovascular system: the scutellaria baicalensis alcohol extract is injected into vein with 1g/kg, so that the blood pressure of the anesthetized dog can be reduced. The scutellaria decoction is injected intravenously at 0.06g/kg, and has obvious blood pressure lowering effect on anesthetized dogs. Baicalein 20mg/kg is injected intravenously, and can reduce the blood pressure of the anesthetized dog by 40-50%. The radix scutellariae infusion is infused into the stomach/kg for 3 times/day for 4 weeks continuously, so that the blood pressure of the chronic renal hypertension dog is reduced, and the heart rate is slowed down. Baicalin 2 x 10(-4) mol/l, has competitive antagonism on contraction action caused by epinephrine, norepinephrine and dopamine in an isolated aortic strip, a pulmonary artery strip, a tracheal strip and a right atrium of a guinea pig, also has antagonism on actions of isoproterenol in dilating trachea and increasing spontaneous frequency of the right atrium, and indicates that the baicalin has blocking effect on receptors a, B1 and B2. 7. Platelet aggregation resistance and anticoagulation: baicalein, wogonin, oroxylin A, baicalein II and chrysin (chrysin) can inhibit collagen-induced platelet aggregation in rats at a concentration of 1.0mM, chrysin also has an inhibitory effect on ADP-induced platelet aggregation, baicalein and wogonin also have an inhibitory effect on arachidonic acid-induced platelet aggregation, and baicalein and baicalin also inhibit the conversion of thrombin-induced fibrinogen into fibrin; the baicalein and baicalin 20, 50mg/kg are administered by intragastric administration, and can prevent the decrease of platelet and fibrinogen content for the diffuse intravascular coagulation of rats induced by endotoxin. 8. Blood fat reducing effect: the water extract of Scutellariae radix with concentration of 10% and 2ml is administered by intragastric administration for 7 weeks to reduce the serum cholesterol content of rabbit fed with cholesterol. The content of free fatty acid, triglyceride and hepatic triglyceride in serum fed by experimental hyperlipemia rat corn oil-cholesterol-cholic acid can be reduced by intragastric administration of baicalein and baicalin of 100mg/kg, the content of total cholesterol and hepatic triglyceride in serum can be reduced by intragastric administration of baicalein II of 100mg/kg, the content of high density lipoprotein-cholesterol (HDL-ch) in serum can be increased, and the content of hepatic triglyceride in serum can be prevented and increased by intragastric administration of wogonin of 100 mg/kg. The baicalein and baicalin are administered at a dose of 100mg/kg to stomach, and can reduce the content of total cholesterol, free cholesterol and triglyceride in liver, while the wogonin can reduce the level of triglyceride in serum, and the baicalein can increase the content of HDL-ch in serum in rats with hyperlipidemia caused by ethanol. 9. Liver protection, gallbladder function promotion and oxidation resistance: the methanol extract of Scutellariae radix is administered by intraperitoneal injection at a dose of 1000mg/kg, and has effects of inhibiting rat liver injury caused by naphthyl isothiocyanate (ANIT) and inhibiting increase of serum bilirubin. The baicalin 50mg/kg and baicalin 100mg/kg are used for intragastric administration, and the composition has choleretic effect on rabbit. In vitro test of wogonin 10(-4) -10(-6) mol/l concentration has effect in inhibiting rat liver microsome lipid peroxidation, and reducing Malondialdehyde (MDA) content. Baicalein and baicalin 2.5 × 10(-4) mol/l, 1.0 × 10(-4) mol/l, wogonin 2.5 × 10(-4) mol/l, baicalein II2.5 × 10(-4) mol/l, wogonin-7-O-D glucuronic acid 2.5 × 10(-4) mol/l, and 1.0 × 10(-4) mol/l, has inhibitory effect on rat liver homogenate lipid peroxidation induced by FeC 12-vitamin C-ADP mixture, significantly reduces formation of liver MDA, and also inhibits lipid peroxidation induced by NADPH-ADP. 10. The anticancer effect is as follows: the Scutellariae radix ether extract has cytotoxic effect on mouse leukemia L1210 cell, half effective amount is 10.4mg/ml, the half effective amount of Scutellariae radix flavone II on mouse L1210 cell is 1.5 μ g/ml, and baicalin, baicalein and wogonin have no significant effect on L1210. 11. Other functions are as follows: baicalein 10, 20mg/kg intravenous injection, has diuretic effect on anesthetized dog. The scutellaria decoction is infused into the stomach by 4g/kg, has prevention and treatment effect on the galactose cataract of rats, and can delay the formation of the cataract. Baicalin has inhibitory effect on rat crystal aldose reductase, and has ID50 of 1.81 × 10(-3) mg/ml. The baicalin of 150mg/kg is perfused into the stomach, the blood sugar level of diabetic rats caused by the streptomycin is not obviously reduced, but the content of the red cell sorbitol is obviously reduced after treatment, which indicates that the composition also has the effect of inhibiting the aldose in animal bodies, and is possibly used for preventing and treating diabetic complications. Baicalin, baicalein and wogonin 50-125 μ g/ml have effect in inhibiting mouse liver sialidase. Baicalin 100mg/kg and glucuronic acid 43mg/kg can be injected subcutaneously to resist the death of mice caused by strychnine, while the aglycon baicalein is ineffective, and the glucuronic acid after the baicalin hydrolysis plays a role in detoxification. The scutellaria has wide influence on the metabolism of PGs, and the aqueous extract has inhibition effect on the biosynthesis of PGs.

In the aspect of toxicological action of the scutellaria baicalensis, the toxicity of the scutellaria baicalensis is extremely low, the decoction is used for gastric lavage of rabbits, the alcohol extract is only weakened in movement after intravenous injection, the scutellaria baicalensis infusion is used for gastric lavage of dogs at 4g/kg for 8 weeks, and no toxic reaction is seen, for example, the yellow mustard infusion at 2g/kg is intravenously injected into healthy rabbits, the patients are calmed firstly, die later, and the toxicity of intravenous injection is much higher than that of oral administration. The total white blood cell count of normal rabbits can be remarkably reduced in a short time by intramuscular and intravenous injection of the scutellaria baicalensis extract. The median lethal dose of baicalein for intraperitoneal injection of mice is 3081 mg/kg. The infusion of scutellaria baicalensis 15 g/kg/gavage has vomit phenomenon for dogs, and the gavage of scutellaria baicalensis 5g/kg is continued for 8 weeks, so that the excrement of the dogs is thin and soft.

In terms of chemical components of scutellaria, scutellaria roots contain flavonoid compounds: baicalein (baicalein), wogonin (neobavacein), i.e., baicalein II (skullcapflavone I), baicalin (baicalin), wogonin (wogonin), wogonin (wogonoside), oroxin A (oxolin A), 7-methoxybaicalein (7-methoxybaicalein), baicalein (skullcapflavone I), dihydrooroxin A (dihydrooxoxin A), chrysin (chrysin), 2,5, 8-trihydroxy-7-methoxyflavone (2,5, 8-trihydroxy-7-methylflavone), 2,5,8-trihydroxy-6,7-dimethoxyflavone (2,5,8-trihydroxy-6,7-dimethoxyflavone), 4, 5-trihydroxy-6, 7-dimethoxyflavone (2,5,8-trihydroxy-6,7-dimethoxyflavone), 4, 5-trihydroxy-6, 7-dimethoxyflavone (4, 5-trihydroxy-6, 7-dimethoxyflavone), 4, 5-trihydroxy-6, 7-methoxyflavone (2,5, 7-dimethoxyflavone), 3,5,6,7-pentahydroxyflavanone (2,3,5,6,7-pentahydroxyflavanone) wogonin-5- β -D-glucoside (wogonin-5- β -D-glucoside), 2- (3-hydroxy-4-methoxyphenyl) -ethyl-1-O- α -L-rhamnosyl (1 → 3) - β -D (4-feruloyl) -glucose [2- (3-hydroxy-4-methoxyphenoyl) ethyl-1-O- α -L-rhamnosyl (1 → 3) - β -D- (4-feruloyl) glucoside ], chrysin; -6-C-alpha-L-arabinoside (chrysin-6-C-beta-D-glucopyranoside-8-C-beta-L-arabinoside), chrysin-6-C-alpha-L-arabinoside-8-C-beta-D-glucoside (chrysin-6-C-alpha-L-arabi-side-8-C-beta-D-glucopyranoside), (2S) -2,5,6, 7-tetrahydroxyflavanone [ (2S) -25,6, 7-tetrahydroxyflavanone ], 5,7,2, 7-tetrahydroxyflavanone (5,7,2, 7-tetrahydroxyflavanone), 5,8-dihydroxy-6, 7-dimethoxyflavone (5,8-dihydroxy-6, 7-dihydroethoxyflavone), 5,7,4-trihydroxy-8-methoxyflavone (5,7,4-trihydroxy-8-methoxyflavone), oroxylin A-7-O-glucuronide (oxoinA-7-O-glucuronide), 5,7, 2-trihydroxy-methoxyflavone (5,7,2-trihydroxy-6-methoxyflavone), 5,2-dihydroxy-6,7, 8-trimethoxyflavone (5,2-dihydroxy-6,7, 8-trimethoxyflavone), 5-gate of a lane-yl-7, 8-dimethoxyflavone (5-hydroxy-7, 8-dimethoxyflavone), norwogonin (norbaicalein), dihydrobaicalein (dihydrobaicalein) [11], 5,7,2-trihydroxyflavone (5,7,2-trihydroxyflavone), 5,7,2-trihydroxy-8,6-dimethoxyflavone (5,7,2-trihydroxy-8,6-dimethoxyflavone), 5,7,2, 5-tetrahydroxy-8. 6-dimethoxy flavone, i.e. viscid-III (5,7,2,5-tetrahydroxy-8, 6-dimethylhydroxyflavone, vis-cidui-III) 5, 25-trihydroxy trimethoxy flavone (5,2, 5-trihydroxy-6, 7,8-trihydroxy flavone), baicalein-7-O-beta-D-glucopyranoside (baicalein-7-O-beta-D-glucopyranoside); 5,7, 2-trihydroxy-8-methoxyflavone (5,7, 2-trihydroxyoxy-8-methoxyflavone) is phloretin II (tenax-in II), 5,2, 6-trihydroxy-7, 8-dimethoxyflavone (5,2, 6-trihydroxy-6-methoxyflavone (5,7,2-trihydroxy-6-methoxyflavone), 5,7,2,3-tetrahydroxyflavone (5,7,2,3-tetrahydroxyflavone), 5,7,2,3-tetrahydroxyflavone (5,7,2-trihydroxy-6-methoxyflavone), 5,7,2,3-tetra gate of a lane-ylflavone (5,7,2,3-tetrahydroxyflavone), 3,5,7,2,5, 6-pentahydroxyflavone (3,5,7,2, 6-hydroxyflavone) (viscucolin I), (2, 6-methoxyflavone) (2, 7, 2-trihydroxy-S) -7, 2-methoxyflavone (5,7, 2-trihydroxy-6-hydroxyflavone), 2,6-trihydroxy-5-methoxyflavanone, 2,6,2,4-tetrahydroxy-6-methoxychalcone (2,6,2,4-tetrahydroxy-6-methoxychalcone) [13], 5,7,2,5-tetrahydroxyflavone (5,7,2, 5-tetrahydroxyflavanone), levo-eriodictyol (eriodicytiol), sculellaria barbata auxin (rivularin), and viscidin III-2-O- β -D-glucopyranoside (viscidin III-2-O- β -D-glucopyranoside). In addition, beta-sitosterol (beta-sitosterol), campesterol (campesterol) and stigmasterol (stigmasterol) [3 ]. 2. Radix Scutellariae Yunnanensis contains Jing baicalein, baicalin, wogonin, 5,7,2-trihydroxy-6-methoxyflavone, (2S) -5,7,8-trihydroxyflavanone [ (2S) -5,7,8-trihydroxyflavanone ]; (2S) -2,5,6, 7-tetrahydroxyflavan baicalein, oroxylin a, scutellarin (scutaemonoside), (2R,3R) -2,3,5, 7-tetrahydroxyflavanone [ (2R,3R) -2,3,5, 7-tetrahydroxyflavanone ], scutellarin (scutaemoenin), (2R,3R) -3,5, 7-trihydroxyflavanone- (2R,3R) -3,5,7-trihydroxyflavanone ], scutellarin II, 2,3,5,6, 7-pentahydroxyflavone, chrysin, β -sitosterol. 3. Scutellaria viscidula root contains baicalin, wogonoside, baicalein, wogonin, oroxylin A, baicalein, 5,2-dihydroxy dimethoxy flavone (panicolin) namely baicalein I, and baicalein I, II and III. Lijiang radix Scutellariae contains baicalein, wogonin, chrysin, oroxylin A, phloretinin II, and viscidin I. The root of Scutellaria Gansu of the same genus contains scutellarin (rehderianin) I, viscid scutellarin III, baicalin, wogonin, scutellarin, oroxylin A, and Gansuqin aglycone (ganhuangenin). Radix Scutellariae contains baicalin, wogonin, baicalein, viscid baicalein I, II, oroxylin A and wogonin.

Concretio silicea Bambusae seu Schizostachyi is a block substance formed by storing bleeding sap in bamboo joints after being bitten by parasitic concretio silicea Bambusae seu Schizostachyi, such as Bambusae seu Schizostachyi of Gramineae, drying and coagulating. Harvesting in winter, cutting bamboo stalk, cutting concretio silicea Bambusae seu Schizostachyi, and air drying. The natural yield of the product is few, and most of the products are made by burning bamboo forest with fire, after the bamboo is exposed to heat, the bamboo juice overflows from the internodes and solidifies, and then the bamboo is cut open and dried. Mainly produced in Yunnan, Guangdong, Guangxi, etc. Has the effects of dispelling pathogenic wind, removing dampness, promoting blood circulation, dredging channels, and relieving cough. Can be used for treating rheumatalgia, numbness of limbs, infantile pertussis, and leukorrhagia. Weishang can treat gastropathy. The Tian Zhu Huang is sweet in flavor and cold in nature, and enters heart and liver meridians. Has effects of clearing heat and eliminating phlegm, and cooling heart and arresting convulsion, and can be used for treating fever unconsciousness, apoplexy with phlegm, infantile convulsion, night cry, infantile convulsion, apoplexy epilepsia, and fever unconsciousness. The efficacy of Tian Zhu Huang for clearing heat-phlegm, clearing heart fire and arresting convulsion is similar to that of Zhu Li without the disadvantage of cold and slippery. For infantile convulsions due to phlegm-heat, Tian Zhu Huang is usually combined with she Xiang, Dan nan xing and Chen Sha, for instance, Bao Long Wan (the formula for infantile syndrome), for apoplexy with phlegm-accumulation and epilepsy due to phlegm-heat, it is combined with Huang Lian, Chang Pu and Yu jin to treat fever with coma and delirium, and it is combined with niu Huang, Lian Qiao and Zhu Ye Ju to roll up heart.

In the aspect of pharmacological action of concretio silicea Bambusae seu Schizostachyi, the water decoction extract of concretio silicea Bambusae seu Schizostachyi can weaken the contractile force of in vitro frog heart and slow the heart rate. Has direct expansion effect on isolated rabbit ear blood vessels, which is shown as increase of perfusion, and the effect is more obvious particularly when the blood vessels are in a contracture state. The mouse is injected with 3.0g/kg of water extract of fungus tabasheer subcutaneously on the back, and has very obvious inhibiting effect on the increase of skin capillary permeability caused by histamine. Intravenous injection of 0.5g/kg of the extract can lower blood pressure in anesthetized rabbits, and its mechanism may be related to the influence on cardiac output and the dilatation of arterioles and reduction of peripheral resistance. Can obviously prolong the plasma recalcification time under the influence on cardiovascular and plasma recalcification time, and can prolong the blood coagulation time in a blood coagulation experiment, possibly related to the prolongation of the recalcification time. The water extract of the fungus tabasheer has 2-3.1g/kg subcutaneous injection, and has better analgesic effect on acetic acid-stimulated pain of mice. The crystal III (hypocrellin A) extracted from concretio silicea Bambusae is administered at 100mg/kg by intragastric administration, and has effect in improving hot plate pain threshold of mouse, and is superior to indomethacin (indomethacin) with effect similar to dolantin (10 mg/kg). Can significantly reduce the frequency of writhing reaction caused by acetic acid and the degree of foot sole swelling caused by egg white. In addition, the fungi Shiraia bambusicola polysaccharide SB1 and SB2 have certain curative effect on hepatitis through pharmacological preliminary tests. In clinical application, Zhu Huang is indicated for infantile convulsions, epilepsy (even opisthotonus), unclear consciousness, cough, dyspnea and thick phlegm. Zhu Huang is used to clear heat and eliminate phlegm, calm and stop epilepsy, often combined with Bei mu, Dan nan xing, Hua fen, Jiang Can, Gou Teng and Chang Pu to strengthen the actions of clearing heat and eliminating phlegm, relieving spasm and inducing resuscitation, and combined with heat-clearing herbs according to the syndrome, such as Zhu Huang Tang. Zhu Huang can also be used to help clear heat in adult fever unconsciousness. For phlegm syncope due to apoplexy (cerebrovascular accident), sudden faint, unconsciousness, tight holding of two fist, snoring, uncomfortable breathing and difficult phlegm generation, it is used with Tianzhu Huang to eliminate phlegm, and combined with Chang Pu, Dan Shen and Sanchi, for instance, it is used in treating wind-cold syndrome.

Mustard is the dried and hot seed of mustard, a plant of the family Brassicaceae. All lines are cultivated. Mainly produced in Anhui, Henan, Hebei, Shanxi, Shandong, Sichuan, etc. The original plants are warm and humid in climate, relatively drought-resistant and favored by sunlight, and are most suitable for growing in fertile and humid sandy loam, and barren, low-lying and water accumulation environments are forbidden. Pungent taste and warm nature; entering lung meridian; has effects of warming lung, eliminating phlegm, activating qi-flowing, resolving hard mass, dredging collaterals and relieving pain. Can be used for treating cough and asthma due to cold phlegm, distending pain in chest and hypochondrium, phlegm stagnation in channels and collaterals, numbness and pain of joints, phlegm dampness and fluid injection, and carbuncle of yin and swelling. Has effects of warming lung, eliminating phlegm, activating qi-flowing, resolving hard mass, dredging collaterals and relieving pain. The clinical names of the seeds are (white) mustard seeds and stir-fried mustard seeds.

Chemical components of mustard, the seed contains sinigrin, myrosinase, sinapic acid, sinapine, fatty oil, protein, and mucilage. The volatile oil obtained after enzymolysis is mustard oil, and contains methyl ester, isopropyl ester, allyl ester, butyl ester, sec-butyl ester, butene-3-ester, pentene-4-ester, phenyl ester, benzyl ester, phenethyl ester and 3-methylthio propyl ester of isothiocyanate. The fatty oil is glyceride of various fatty acids, and the fatty acids are erucic acid, eicosene-11-acid, oleic acid, linoleic acid, linolenic acid, palmitic acid, arachidic acid, stearic acid, and behenic acid.

In the aspect of the pharmacological action of the mustard, the stimulation effect is as follows: semen Brassicae Junceae contains sinigrin, and the sinapside has no irritation, but generates volatile oil with myrosinase when it is in water, and contains allyl isothiocyanate as main ingredient, and has pungent taste and irritation. Applied to the skin, has a warm feeling and makes it reddish, even causing blisters and pustules. The mustard powder is usually prepared into mustard plaster after fatty oil is removed, and is used as an anti-irritant (the effect of an irritant drug used on the skin part is not limited to the application part, and the irritant drug is involved in other parts to produce a treatment effect, namely an anti-irritation effect), and the treatment of neuralgia, rheumatalgia, pleuritis, sprain and the like is realized. Before use, the plant is moistened with warm water to enhance the action of myrosinase (the boiled water inhibits the action of myrosinase). The application time is no longer than 15-30 min, and the application time is only 5-10 min for skin sensitive people. Mustard powder is used as a flavoring agent to increase salivary secretion and amylase retrogradation, and to decrease heart volume and heart rate. Small amount can stimulate gastric mucosa to increase secretion of gastric juice and pancreatic juice, and sometimes can relieve intractable hiccup. It can cause vomiting rapidly after being taken orally in large amount, and can be used for treating narcotic drug intoxication. Other functions are as follows: feeding guinea pigs with mustard results in inhibited thyroid uptake and serum SCN-elevation. However, it was not found how the SCN-content in the food was related to the inhibition of intake. It has also been reported that animals fed brassica plants for extended periods of time can develop enlarged thyroid glands, possibly due to excessive secretion of thyroid stimulating hormone. When the rabbit is injected with the mustard physiological saline leachate by vein injection, the blood pressure is slightly increased at first, then is reduced, and the respiration is increased. It can be orally administered as irritant expectorant, and can be used for treating abdominal pain and gastrointestinal inflammation due to excessive dose.

Through a simple traditional Chinese medicine formula and even through a simple medicine application mode, the invention has surprisingly found that the obtained traditional Chinese medicine composition has excellent physiological effects, and particularly can be used for treating lung heat cough, profuse phlegm, wheezing, yellow phlegm, red tongue with yellow coating, clearing lung, eliminating phlegm, relieving cough and asthma; more particularly, the medicine can be used for treating cough, profuse phlegm, wheezing, yellow phlegm, red tongue and yellow fur of children patients with lung heat, and can be used for clearing lung, eliminating phlegm, relieving cough and relieving asthma.

Detailed Description

The present invention will be further described by the following examples, however, the scope of the present invention is not limited to the following examples. It will be understood by those skilled in the art that various changes and modifications may be made to the invention without departing from the spirit and scope of the invention. The present invention has been described generally and/or specifically with respect to materials used in testing and testing methods. Although many materials and methods of operation are known in the art for the purpose of carrying out the invention, the invention is nevertheless described herein in as detail as possible. In the invention, all the medicinal materials are dry medicinal materials and accord with the rules of pharmacopoeia if not specified. In the following examples of the present invention, the charged amount of each material was calculated in parts by weight, and when actually charged, the total weight of the whole materials per batch was not less than 5 kg.

Example 1: preparation of a Chinese medicinal composition

The formula is as follows: 1 part of scutellaria baicalensis, 1 part of tabasheer and 0.15 part of mustard seed.

The preparation method comprises the following steps: pulverizing the above materials into fine powder capable of passing through 120 mesh sieve, and mixing at a certain proportion;

taking half of the mixed powder, adding 1/2 amount of honey, making into oral honeyed pill, and sealing, wherein each pill is 0.2g calculated by Scutellariae radix;

mixing the other half of the mixed powder with 1/2 amount of edible vinegar, mixing thoroughly, concocting into paste, placing the paste in a patch, and sealing, wherein the amount of each patch is 0.5g based on Scutellariae radix.

Example 2: preparation of a Chinese medicinal composition

The formula is as follows: 1 part of scutellaria baicalensis, 5 parts of tabasheer and 0.05 part of mustard seed.

The preparation method comprises the following steps: pulverizing the above materials into fine powder capable of passing through 100 mesh sieve, and mixing at a certain proportion;

taking half of the mixed powder, adding 1/5 amount of honey, making into oral honeyed pill, and sealing, wherein each pill is 0.2g calculated by Scutellariae radix;

mixing the other half of the mixed powder with 1/2 amount of edible vinegar, mixing thoroughly, concocting into paste, placing the paste in a patch, and sealing, wherein the amount of each patch is 0.25g based on Scutellariae radix.

Example 3: preparation of a Chinese medicinal composition

The formula is as follows: 1 part of scutellaria baicalensis, 0.2 part of tabasheer and 2 parts of mustard seed.

The preparation method comprises the following steps: pulverizing the above materials into fine powder capable of passing through 80 mesh sieve, and mixing at a certain proportion;

taking half of the mixed powder, adding 1/3 amount of honey, making into oral honeyed pill, and sealing, wherein each pill is 0.2g calculated by Scutellariae radix;

mixing the other half of the mixed powder with 1/1.5 of water, mixing, concocting into paste, placing the paste into a medicinal patch, and sealing, wherein the amount of each patch is 0.25g based on Scutellariae radix.

Example 4: preparation of a Chinese medicinal composition

The formula is as follows: 1 part of scutellaria baicalensis, 2.5 parts of tabasheer and 0.1 part of mustard seed.

taking half of the mixed powder, directly filling into hard capsules, making into oral capsules, and sealing, wherein each capsule is 0.2g calculated by scutellaria;

mixing the other half of the mixed powder with 1/1.5 of yellow wine, blending into paste, placing the paste into a medicinal patch, and sealing, wherein each patch is 0.25g calculated by Scutellariae radix.

Example 5: preparation of a Chinese medicinal composition

The formula is as follows: 1 part of scutellaria baicalensis, 0.25 part of tabasheer and 1 part of mustard.

taking half of the mixed powder, adding 1/1.2 of Mel, making into oral honeyed pill, and sealing, wherein each pill is 0.2g calculated by Scutellariae radix;

Example 6: preparation of a Chinese medicinal composition

The preparation method comprises the following steps: taking the medicinal materials according to the prescription amount, adding 6 times of water for decocting and extracting for 2 hours, taking decoction, adding 5 times of water for decocting medicinal residues for 1.5 hours, taking decoction, combining decoction, filtering, concentrating under reduced pressure, spray drying to obtain extract, sealing and packaging, wherein each bag is equivalent to 1g of scutellaria baicalensis, and the extract is taken as medicinal granules (granules) for oral administration.

Example 7: preparation of a Chinese medicinal composition

The formula is as follows: 1 part of scutellaria (wine), 2.5 parts of tabasheer and 0.1 part of mustard seed (yellow, fried).

The preparation method comprises the following steps: taking the medicinal materials according to the prescription amount, adding 6 times of 65% ethanol for reflux extraction for 2 hours, taking an extracting solution, adding 5 times of 65% ethanol for reflux extraction for 1.5 hours to the dregs, taking the extracting solution, combining the extracting solutions, filtering, carrying out reduced pressure concentration to remove the ethanol, carrying out spray drying, adding one time of sucrose, preparing a soft material, granulating, drying, carrying out sealed packaging, wherein each bag is equivalent to 1g of scutellaria baicalensis, and taking the mixture as medicinal granules (granules) for oral administration.

Example 8: preparation of a Chinese medicinal composition

The formula is as follows: 1 part of (fried) scutellaria baicalensis, 0.25 part of (bamboo of Hua-Sichuan of China) concretio silicea bambusae and 1 part of (yellow) mustard seeds.

The preparation method comprises the following steps: taking the medicinal materials according to the prescription amount, adding 75% ethanol with the amount of 6 times of the medicinal materials, carrying out reflux extraction for 2 hours, taking the extract liquid, adding 75% ethanol with the amount of 5 times of the medicinal residues, carrying out reflux extraction for 2 hours, taking the extract liquid, combining the extract liquids, filtering, carrying out reduced pressure concentration to remove the ethanol to obtain clear paste, wherein each 100g of the clear paste is equivalent to 10g of scutellaria baicalensis, adding PEG400 with the amount of 25% of the clear paste and PEG4000 with the amount of 20% of the clear paste, uniformly mixing, and preparing into ointment for external use.

Example 9: preparation of a Chinese medicinal composition

The formula is as follows: 1 part of scutellaria (charcoal), 2 parts of tabasheer and 0.1 part of mustard seed.

The preparation method comprises the following steps: extracting the above materials with 6 times of water for 2 times, mixing extractive solutions, filtering, concentrating the filtrate, spray drying to obtain 4 kinds of extract powder, and adding water into the extract to obtain oral liquid, wherein each 5ml of the oral liquid is equivalent to 0.25g of Scutellariae radix.

Example 10: preparation of a Chinese medicinal composition

The formula is as follows: 1 part of scutellaria baicalensis, 0.5 part of tabasheer and 0.5 part of mustard seed.

The preparation method comprises the following steps: extracting Scutellariae radix with 6 times of water for 2 times, and mixing extractive solutions; extracting concretio silicea Bambusae seu Schizostachyi and semen Brassicae Junceae with 6 times of water for 2 times, and mixing extractive solutions; mixing the two extractive solutions, filtering, concentrating the filtrate, and spray drying to obtain extract powder, and adding water into the extract to obtain oral liquid, wherein each 5ml of the oral liquid is equivalent to 0.25g of Scutellariae radix.

Example 11: preparing a traditional Chinese medicine composition: referring to the formulation and process of example 6, except that no scutellaria, tabasheer, or mustard was added to the composition, three compositions were obtained, each lacking one of the traditional Chinese medicinal materials.

Example 12: determination of sinapine thiocyanate in compositions using HPLC method

A. The determination method comprises the following steps:

preparation of a test solution: taking a sample corresponding to 1g of mustard seed medicinal material, precisely weighing, placing in a conical flask with a plug, adding 50ml of methanol, 100mg of calcium chloride and 20 mul of glacial acetic acid, carrying out ultrasonic treatment for 20 minutes at the power of 250W and the frequency of 20kHz, filtering, extracting filter residues for three times by using the same method with methanol, and combining filtrates; recovering solvent under reduced pressure, dissolving the residue with mobile phase, transferring to 50ml measuring flask, diluting with mobile phase to scale, shaking, filtering, and collecting filtrate;

B: measurement results

Using the HPLC method above, mustard drug and various compositions prepared according to the present invention were assayed and the results showed:

(1) the content of sinapine thiocyanate in different types/batches of mustard medicinal materials is within the range of 0.84-1.13%, and the requirements of pharmacopoeia limits are met;

(2) measuring the compositions obtained in examples 1-10, respectively, and calculating the measured sinapine thiocyanate content; calculating the theoretical content of sinapine thiocyanate in the composition according to the theoretical material amount of the sinapine and the sinapine thiocyanate content in the sinapine in the composition; dividing the measured content by the theoretical content and multiplying by 100% to obtain the percentage, and taking the percentage as the recovery rate of the sinapine thiocyanate; the recovery rate of sinapine thiocyanate in all compositions obtained in examples 1-10 is within 96-101%, and the method has excellent effect;

(3) according to the method (2), the two compositions of the scutellaria baicalensis, the mustard and the tabasheer and the mustard obtained in the example 11 are respectively measured, the recovery rate of sinapine thiocyanate of the two compositions is within the range of 97-99%, and the method has excellent effect;

in another supplementary test of the present invention, referring to the HPLC method of example 12 above, the results of the mustard herb and various compositions were measured with the exception of the preparation of the sample solution (a) without addition of calcium chloride and glacial acetic acid, (b) without addition of calcium chloride, (c) without addition of glacial acetic acid, and showed that:

(1) the three conditions of (a), (b) and (c) are used, the content of sinapine thiocyanate in different types/batches of mustard medicinal materials is within the range of 0.81-1.11%, the requirement of pharmacopoeia limit is met, and the data is basically the same as that in example 12;

(2) the compositions obtained in examples 1 to 10 were measured under the three conditions (a), (b) and (c), respectively, and the recovery rates of sinapine thiocyanate were all in the range of 43 to 58% for all the compositions in examples 1 to 10, indicating that a large amount of the objective substance was not measured;

(3) the recovery rates of sinapine thiocyanate of the composition comprising scutellaria and mustard were in the range of 48-53% and the recovery rate of sinapine thiocyanate of the composition comprising tabasheer and mustard were in the range of 98-102% when the two compositions of scutellaria + mustard and tabasheer and mustard obtained in example 11 were measured using the three conditions (a), (b) and (c), respectively, showing that the presence of scutellaria may have an effect on the determination of the target.

(4) Referring to the formulations and methods of examples 1-5 and 7-9 above, except that no scutellaria was added, a composition without added scutellaria was obtained; the recovery rate of sinapine thiocyanate in the obtained composition is respectively measured by using the three conditions of (a), (b) and (c), and the result is in the range of 97-102%, which further proves that the influence on the determination of the target substance due to the existence of the scutellaria probably exists, however, the influence can be overcome by a method of adding calcium chloride and glacial acetic acid in the process of preparing the test solution.

Experimental example 1: the composition of the invention has curative effect on infantile cough and asthma

1. Case selection: the Western diagnosis meets the diagnosis standard of cough and asthma in 2002 ' Utility science ' 7 th edition, and the traditional Chinese medicine diagnosis meets the diagnosis standard of cold drink over lung syndrome in the ' standard of curative effect of diagnosis of traditional Chinese medicine syndrome ' released by the State administration of traditional Chinese medicine ' 1994. The clinical manifestations are cough and asthma, wheezy phlegm in the throat, white and sticky phlegm or thin and foamy phlegm, severe phlegm when it is cold, pale white face, pale red tongue with white and slippery coating, and superficial and slippery pulse. 180 patients with the age of 1.5-8 years are selected and randomly divided into 2 treatment groups, and 90 patients in each group have no obvious difference in samples.

2. The treatment method comprises the following steps: two groups of treatment components are provided, the first group is applied with the patch of the embodiment 1, and is applied to the Tiantu acupoint 1 time a day, and 7 days are 1 course of treatment; the second group is administered the formulation of example 6 twice daily, each time corresponding to 0.25g of Scutellariae radix, and 7 days are 1 course of treatment.

3. And (3) judging the curative effect: refer to the diagnosis and treatment guidelines for common diseases in internal medicine of traditional Chinese medicine, the part of TCM syndrome. And (3) curing: occasionally light cough, but can be relieved without administration, or occasionally light cough, clinical symptoms disappear; the effect is shown: the clinical symptoms are obviously relieved, and the cough still has regular attacks, but the frequency is obviously reduced; the method has the following advantages: cough attacks at regular intervals, but with a relatively reduced number; and (4) invalidation: the number of cough episodes or symptoms did not improve or even worsen.

4. As a result: after a treatment course, the treatment effects of each group are counted according to the treatment effect judgment standard, and the counting result and the total effective rate are as follows: example 1: 56 cases are cured, 22 cases are obviously effective, 9 cases are effective, and 3 cases are ineffective, and the total effective rate is 96.7 percent; example 6: 53 cases are cured, 27 cases are obviously effective, 8 cases are effective, 2 cases are ineffective, and the total effective rate is 97.8 percent.

From the results, the two compositions in examples 1 and 6 have obvious effect on infantile cough and asthma when being administered by different routes, and the effective rate reaches over 96.0%.

Experimental example 2: pharmacodynamic study on lung clearing, phlegm eliminating, cough relieving and asthma relieving of composition

The test mainly carries out pharmacodynamic research on the aspects of relieving cough, reducing phlegm and relieving asthma on the composition, so as to provide experimental theoretical basis for clinically applying the composition to clear lung, reduce phlegm, relieve cough and relieve asthma.

1. Experimental Material

(1) Drugs and reagents: the composition of the invention in the embodiments 6, 9 and 10, Guilong Kechuanning capsule (Anhui Guilong pharmaceutical industry); dextromethorphan hydrobromide capsules, carbocisteine tablets and aminophylline tablets are all commercially available preparations. Ammonia, phenol red and sodium bicarbonate are all analytical reagents.

(2) Animals: ICR mice and guinea pigs are provided by the Experimental animals center of the basic medical institute of Jilin university, and the animal license numbers are as follows: SCXK (George) 2007-.

(3) Instruments and equipment: YLS-8A multifunctional cough-inducing asthma-inducing instrument, Equipment station of Shandong province medical academy of sciences; DT-100 analytical balance, Beijing optical instruments factory; 721 spectrophotometer, Shandong high density rainbow Analyzer Co., Ltd; TD5A-WS Low speed desk centrifuge, Changshan appearance centrifuge instruments Ltd; binocular biomicroscope, japan OLYMPUS.

(4) The statistical method comprises the following steps: results for each group are expressed as (x ± s), data are statistically analyzed with software DAS2.1.1, and comparisons between groups are tested with t.

2. Method and results

(1) Effect on cough in mice caused by concentrated ammonia spray:

60 ICR mice (18-22 g) were divided into 6 groups of male and female halves at random according to body weight, and each group was divided into 10 groups, namely a blank control group, the composition of example 6 (equivalent to 0.5g of Scutellaria baicalensis/kg of animal body weight), the composition of example 9 (equivalent to 0.5g of Scutellaria baicalensis/kg of animal body weight), the composition of example 10 (equivalent to 0.5g of Scutellaria baicalensis/kg of animal body weight), Guilong Kechuanning capsule (0.6g/kg) and dextromethorphan hydrobromide (0.015 g/kg). Gavage (ig) was administered 1 time per day for 5 consecutive days, and the blank control group was given an equal volume of distilled water. Before the test, each group of mice is fasted for 16h, 30min after the last administration, the mice are put into a cough inducing asthma apparatus added with strong ammonia water, the mice are atomized for 15s, and the cough latency (the time from the beginning of the atomization to the cough of the animals) and the cough frequency within 2min [ Liyuq. 428, 771, 734]. As a result of the effect (x. + -.s) of the composition on the cough of mice caused by the concentrated ammonia water spraying method, the latency(s) of each group was as follows: blank control group 22.2 ± 5.3, example 6 composition 36.4 ± 11.2, example 9 composition 34.2 ± 9.1, example 10 composition 35.7 ± 14.1, guilong kechuanning capsule group 33.4 ± 7.3, dextromethorphan hydrobromide group 36.3 ± 8.6; the number of coughs (times) for each group was as follows: blank control 52.3 ± 11.3, example 6 composition 32.3 ± 10.6, example 9 composition 31.1 ± 9.7, example 10 composition 33.6 ± 8.4, guilong chuanning capsule group 41.7 ± 12.3, dextromethorphan hydrobromide group 32.4 ± 11.7; wherein P <0.05 and P <0.01, compared to the blank control group.

The results show that the composition group, the Guilong Kechuanning capsule group and the dextromethorphan hydrobromide group can prolong the cough incubation period of mice and reduce the cough frequency, and have significant difference (P <0.05 or P <0.01) compared with a blank control group. In addition, the test method is considered for the cough relieving effect of the three compositions obtained in the example 11, and the results show that the mean value of the latent period of the three compositions is within the range of 19-23 seconds, the mean value of the cough times is within the range of 50-53 times, and no statistical difference exists in comparison with a blank control group, so that the ideal cough relieving effect cannot be obtained when any one of the four medicinal material combinations is lacked.

(2) Influence on mouse respiratory phenol red excretion

Taking 60 ICR mice of 18-22 g, dividing the mice into 6 groups according to the weight of each half, wherein 10 mice in each group are divided into a blank control group, a composition (equivalent to 0.5g of scutellaria baicalensis/kg of animal weight) in the example 6, a composition (equivalent to 0.5g of scutellaria baicalensis/kg of animal weight) in the example 9, a composition (equivalent to 0.5g of scutellaria baicalensis/kg of animal weight) in the example 10, a Guilong Kechuanning capsule (0.6g/kg) in the example 10 and a carbocisteine (0.2g/kg) in the blank control group, wherein ig is administrated for 1 time per day for 7 days continuously, and distilled water with equal volume is administrated in the blank control group. Before the test, mice in each group are fasted for 16 hours, 30 minutes after the last administration, the mice are subjected to intraperitoneal injection of 0.2mL/10g of phenol red solution, 30 minutes after the phenol red injection, animals are killed by air embolism, tissues around the trachea are stripped, a section of trachea from the lower part of the thyroid cartilage to the branch part of the trachea is cut, the trachea is placed into a test tube containing 3mL of physiological saline, 0.1mL of 5% sodium bicarbonate is added to adjust the pH value, a 721 type spectrophotometer is used for measuring the OD value at the wavelength of 546nm, the phenol red is used for making a standard curve, and the content of the phenol red is calculated according to the curve [ Chengqi. traditional Chinese medicine pharmacology research methodology [ M ]. Beijing: public health press, 1993: 642]. Phenol red standard curve: y is 0.0595X +0.0053, where R is 0.9999, Y is the OD value, and X is the phenol red content (μ g/mL). The effect of each composition on mouse respiratory phenol red excretion (x ± s) is expressed as phenol red concentration (μ g/mL) and the results are as follows: blank control group 2.08 + -0.74, example 6 composition 3.87 + -1.51, example 9 composition 3.98 + -1.24, example 10 composition 3.81 + -1.66, Guilong Kechuanning capsule group 3.34 + -0.86, and carbocisteine group 3.27 + -1.17. Wherein P <0.05 compared to the blank control group. The results show that the composition group, the high-dose group, the Guilong Kechuanning capsule group and the carbocisteine group can increase the phenol red excretion amount of the respiratory tract of the mouse, and have significant difference (P is less than 0.05) compared with a blank control group. In addition, the test method is considered for the phlegm reducing effect of the three compositions obtained in the example 11, and the result shows that the mean value of the phenol red concentration (mu g/mL) of the three compositions is within the range of 2.1-2.2, and the three compositions have no statistical difference compared with a blank control group, which indicates that the ideal phlegm reducing effect cannot be obtained by any one of the four medicinal material combinations.

(3) Effect on egg protein-induced allergic asthma in Guinea pigs

The weight of 60 guinea pigs is 200-350 g, the guinea pigs are randomly divided into 6 groups according to the weight, and each group comprises 10 animals, namely a model control group, a composition (equivalent to 0.3g of scutellaria baicalensis/kg of animal weight) in example 6, a composition (equivalent to 0.3g of scutellaria baicalensis/kg of animal weight) in example 9, a composition (equivalent to 0.3g of scutellaria baicalensis/kg of animal weight) in example 10, a Guilong Kechuanning capsule (0.35g/kg) in example 10 and an aminophylline tablet (0.045 g/kg). Reference is made to the literature [ Zhuangjian, et al. Effect of asthma-relieving plaster application on airway inflammation in asthmatic guinea pigs [ J ]. proceedings of Shandong university of traditional Chinese medicine, 2003, 27 (1): 66-67] molding method with slight improvement: each group of animals was injected with 1 mL/animal of 10% egg protein physiological saline solution intraperitoneally. After 2 weeks ig administration was started 1 time a day for 7 consecutive days. Spraying 1% egg protein normal saline solution with asthma inducing instrument from day 17, inhaling the animal for 15min, and inducing asthma 1 time every other day for 3 times. The asthma-inducing latency, i.e. the time from the onset of nebulization to the onset of asthma attack (manifested as coughing, dyspnea, dysphoria, convulsions, falls and even death), was recorded at the last challenge, calculated at 6min when no asthma attack occurred over 6 min.

24h after the last challenge, the guinea pig was anesthetized with sodium pentobarbital, the cervical trachea was isolated, the gavage needle was inserted into the trachea for bronchoalveolar lavage, 6ml of saline was withdrawn, each time slowly injected, the withdrawal was repeated after 20s, 3 times, and a small amount of lavage fluid (BALF) was taken and added with 1% hydrochloric acid equivalent for white blood cell counting. As a result of the effect (x. + -.s) of the composition on the incubation period of asthma induced by guinea pig egg protein, the incubation periods(s) of the respective groups were as follows: 32.5 + -14.4 of the model control group, 59.3 + -18.1 of the composition of example 6, 63.1 + -10.4 of the composition of example 9, 66.2 + -14.7 of the composition of example 10, 57.5 + -16.4 of the Guilong Kechuanning capsule group and 63.4 + -21.3 of the aminophylline group; leukocyte count for each group (× 10)⁹L) are as follows: model control group 11.33 ± 4.21, example 6 composition 2.02 ± 0.74, example 9 composition 2.21 ± 0.67, example 10 composition 1.93 ± 0.84, Guilong Kechuanning capsule group 2.96 ± 0.73, aminophylline group 3.83 ± 1.18; wherein P is compared with model control group<0.05，**P<0.01. The results show that the composition group, the Guilong Kechuanning capsule group and the aminophylline group can prolong the asthma-inducing incubation period of the guinea pig and reduce the number of white blood cells in the guinea pig BALF, and have significant difference (P) compared with a model control group<0.05 or P<0.01). The three compositions obtained in example 11 were examined for their antiasthmatic action by referring to this test method, and the results showed that the mean incubation periods of the three compositions were in the range of 33 to 38 seconds and the white blood cell count (. times.10)⁹the/L) mean value is in the range of 9.2-9.7, and no statistical difference exists when compared with a blank control group, which indicates that the ideal asthma relieving effect cannot be obtained when any one of the four medicinal material combinations is lacked.

It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

Claims

1. A traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials and optional pharmaceutic adjuvants: 1 part by weight of scutellaria baicalensis, 0.2-5 parts by weight of tabasheer and 0.05-2 parts by weight of mustard seed.

2. The Chinese medicinal composition according to claim 1, which is prepared from the following Chinese medicinal materials in proportion: 1 part by weight of scutellaria baicalensis, 0.25-2.5 parts by weight of tabasheer and 0.1-1 part by weight of mustard seed.

3. The traditional Chinese medicine composition according to claim 1, characterized in that:

the traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials in proportion: 1 part by weight of scutellaria baicalensis, 0.5-2 parts by weight of tabasheer and 0.1-0.5 part by weight of mustard seed; and/or

The traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials in proportion: 1 part of scutellaria baicalensis, 1 part of tabasheer and 1 part of mustard.

4. The traditional Chinese medicine composition according to claim 1, characterized in that:

the scutellaria baicalensis is added into the composition in the form of medicinal material powder, or in the form of an extract thereof, or in the form of an extract obtained by extracting the scutellaria baicalensis with other one or more medicinal materials;

the concretio silicea Bambusae seu Schizostachyi is added into the composition in the form of medicinal material powder, or in the form of its extract obtained by extracting with other one or more medicinal materials; and/or

The mustard is added to the composition in the form of powder of the herb, or in the form of an extract thereof extracted with one or more other herbs.

5. The traditional Chinese medicine composition according to claim 1, characterized in that:

the medicinal material powder is powder which can pass through a sieve of at least 80 meshes, or powder which can pass through a sieve of at least 100 meshes, or powder which can pass through a sieve of at least 120 meshes;

the extract, whether the extract of a single medicinal material or the extract obtained by extracting a plurality of medicinal materials together, can be extracted by a solvent selected from the group consisting of: water, ethanol, and ethanol aqueous solutions, such as 10-90% ethanol;

the extraction may be any extraction means or combination thereof known in the pharmaceutical art, such as, but not limited to: soaking, decocting, percolating, etc., preferably removing solvent after extraction;

the powder may optionally be combined with liquid or semi-solid excipients, for example water, ethanol, such as yellow wine, acetic acid, such as vinegar, aqueous solutions thereof, and the like, to form a paste for external use;

it is an external preparation; for example, the external preparation is in the form of a patch, ointment, cream, etc.; for example, the external preparation is prepared by mixing the powder of the medicinal materials and liquid or semisolid auxiliary materials into paste (for example, the weight ratio of the medicinal powder to the liquid auxiliary materials is 1-5: 1); and/or

It is an oral preparation; for example, the oral preparation is in the form of granules, tablets, capsules, oral liquids, granules, pills, sprays and the like.

6. The Chinese medicinal composition according to claim 1, which is an external preparation or an oral preparation, and is prepared according to the following steps: pulverizing the above materials into fine powder, or extracting the above materials separately or in any combination to obtain extract, and making into external preparation or oral preparation by use of preparation process, wherein medicinal adjuvants are optionally added.

7. A method for preparing the Chinese medicinal composition of any one of claims 1 to 6, which is an external preparation or an oral preparation, and is prepared by the following steps: pulverizing Scutellariae radix, concretio silicea Bambusae seu Schizostachyi, and semen Brassicae Junceae into fine powder, or extracting each medicinal material separately or optionally to obtain extract, and preparing the obtained fine powder or extract into external preparation or oral preparation by preparation process, optionally adding medicinal adjuvants.

8. The method of claim 7, wherein:

the traditional Chinese medicine composition is an external preparation; for example, the external preparation is in the form of a patch, ointment, cream, etc.; for example, the external preparation is prepared by mixing the powder of the medicinal materials and liquid or semisolid auxiliary materials into paste (for example, the weight ratio of the medicinal powder to the liquid auxiliary materials is 1-5: 1);

the traditional Chinese medicine composition is an oral preparation; for example, the oral preparation is in the form of granules, tablets, capsules, oral liquids, granules, pills, sprays and the like; and/or

The traditional Chinese medicine composition is an external preparation or an oral preparation, and is prepared according to the following steps: pulverizing the above materials into fine powder, or extracting the above materials separately or in any combination to obtain extract, and making into external preparation or oral preparation by use of preparation process, wherein medicinal adjuvants are optionally added.

9. The application of the combination of the following traditional Chinese medicinal materials in preparing the medicine for clearing lung, eliminating phlegm, relieving cough and asthma or preparing the medicine for treating lung-heat cough, excessive phlegm, wheezing, yellow phlegm, red tongue and yellow fur: scutellariae radix, concretio silicea Bambusae seu Schizostachyi, and semen Brassicae Junceae.

10. The use according to claim 9, the medicament is for clearing lung heat, resolving phlegm, relieving cough and asthma in a pediatric patient or for treating cough with lung heat, profuse phlegm, wheezing, yellow phlegm, red tongue with yellow coating in a pediatric patient; or, the medicament is the traditional Chinese medicine composition of any one of claims 1 to 6; or the medicine is a traditional Chinese medicine composition prepared by the method of claims 7-8.