Traditional Chinese medicine composition for clearing lung and eliminating phlegm as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicine compositions, and discloses a traditional Chinese medicine composition for preventing and treating phlegm-heat obstructing lung type cough, the traditional Chinese medicine composition contains effective prevention and treatment dose of monarch drugs, ministerial drugs, adjuvant drugs and conductant drugs which are stored in a mixed manner or independently stored, and the monarch drugs comprise scutellaria baicalensis and white mulberry root-bark; the ministerial drugs comprise cortex phellodendri, fructus gardeniae and bulbus fritillariae thunbergii; the adjuvant drugs comprise platycodon grandiflorum, radix peucedani, radix sophorae flavescentis, rhizoma anemarrhenae, rhizoma atractylodis macrocephalae, radix trichosanthis and rhizoma zingiberis; the conductant drug comprises honey-fried licorice root. The invention provides a traditional Chinese medicine composition for treating phlegm-heat obstructing lung type cough, which is stable in preparation quality, exact in curative effect, safe and effective according to the theory of traditional Chinese medicine, so as to solve the problem of early recovery of patients with phlegm-heat obstructing lung type cough, and the traditional Chinese medicine composition is prepared by taking common traditional Chinese medicines as raw materials through reasonable formula compatibility. The traditional Chinese medicine can be used for effectively treating cough and yellow and thick phlegm caused by phlegm-heat obstructing lung.

Description

Technical Field

[0001] The invention belongs to the technical field of Chinese medicine compositions, and relates to a Chinese medicine composition for clearing the lungs and resolving phlegm, in particular to a Chinese medicine composition for clearing the lungs and resolving phlegm, and a preparation method and application thereof. Background Art

[0002] Coughing is an important defensive nerve reflex of the body, which is beneficial for clearing respiratory secretions and harmful factors. It is a common respiratory symptom. According to its nature, it can be divided into dry cough and wet cough (daily sputum volume>10mL). Air pollution, seasonal factors, dietary factors, occupational factors, allergens, smoking, advanced age, obesity, combined with bronchial asthma / chronic obstructive pulmonary disease / gastroesophageal reflux disease / bronchiectasis, etc. are all risk factors for chronic cough. Coughing with sputum is a common symptom of respiratory diseases. Sputum is mucus secreted by the respiratory tract. Coughing to expel sputum can keep the respiratory tract self-cleaning and unobstructed; if it is not expelled, not only will the disease be difficult to cure, but it will also easily block the respiratory tract, causing poor breathing. In severe cases, it will cause dyspnea and endanger life.

[0003] Phlegm-heat blocking the lung type cough is a type of internal injury cough in traditional Chinese medicine. Symptoms include cough, shortness of breath, or phlegm in the throat. The phlegm is thick or yellow and difficult to cough up, or has a hot and fishy smell, and the patient wants to drink water. The tongue is red, the tongue coating is thin and greasy, and the pulse is slippery and rapid.

[0004] At present, there are many methods for treating cough. Western medicine can be divided into three categories: the first category is central cough suppressants, such as opium, morphine, dextromethorphan, etc. This type of drug can selectively inhibit the medullary cough center to produce a cough suppressant effect. The effect of this type of cough suppressant is clear, but it has obvious side effects. In addition to slightly inhibiting the respiratory center, gastrointestinal reactions, and drowsiness, the more serious side effect is the dependence and tolerance on this type of drug, which constitutes mental damage. The second type of drug is peripheral cough suppressants, such as benproperin phosphate, etc. This type of drug blocks the incoming impulse of the cough reflex by inhibiting the pulmonary-vagus nerve reflex, and has a cough suppressant effect. It is commonly used for irritating dry coughs and cough suppressants caused by acute bronchitis, bronchial asthma, pneumonia, and lung cancer. The defect of this type of drug is that the scope of application is narrow, and it can only be effective for certain specific types of coughs (without sputum). The third category is atomization inhalation therapy and bronchoalveolar lavage. This treatment method is relatively professional and difficult to operate. However, no matter which method is used, it is impossible to clearly explain the cause of cough on a pathological basis and cure it.

[0005] With the continuous development of Chinese medicine in my country, people have gradually realized the advantages of Chinese medicine in treating cough and sputum caused by phlegm-heat blocking the lungs, and the advantages of good efficacy, quick effect, and small toxic and side effects in the treatment process. Therefore, it is necessary to provide a new cough suppressant with better efficacy, simultaneous treatment of causes and symptoms, and no toxic and side effects. Then, how to find such a drug is an urgent problem to be solved by those skilled in the art. Summary of the invention

[0006] The purpose of the present invention is to overcome the deficiencies in the prior art and provide a traditional Chinese medicine composition for clearing the lungs and reducing phlegm, and a preparation method and application thereof.

[0007] The technical solution adopted by the present invention to solve its technical problem is:

[0008] A Chinese medicine composition for preventing and treating phlegm-heat blocking lung type cough, the Chinese medicine composition contains effective amounts of two or more main drugs, ministerial drugs, adjuvant drugs and guiding drugs stored in a mixed or separate manner, wherein:

[0009] The monarch drugs include: Scutellaria baicalensis and Morus alba bark;

[0010] The ministerial drugs include: Phellodendron amurense, Gardenia jasminoides, and Fritillaria thunbergii;

[0011] The adjuvants include: Platycodon grandiflorum, Peucedanum chinense, Sophora flavescens, Rhizoma Anemarrhenae, Atractylodes macrocephala, Radix Trichosanthis, and dried ginger;

[0012] The adjuvant drug includes: roasted licorice root.

[0013] Furthermore, in the traditional Chinese medicine composition, compared with 100 parts by weight of the roasted liquorice, the content of the Radix Trichosanthis is 110-140 parts by weight, the content of the dried ginger is 30-60 parts by weight, the content of the Atractylodes macrocephala is 140-170 parts by weight, the content of the Peucedanum peucedanum is 45-75 parts by weight, the content of the Platycodon grandiflorum is 110-140 parts by weight, the content of the Sophora flavescens is 80-110 parts by weight, the content of the Phellodendron chinense is 45-75 parts by weight, the content of the Fritillaria thunbergii is 120-160 parts by weight, the content of the Anemarrhena asphodeloides is 80-110 parts by weight, the content of the Gardenia jasminoides is 110-140 parts by weight, the content of the Morus alba bark is 140-170 parts by weight, and the content of the Scutellaria baicalensis is 140-170 parts by weight.

[0014] Further, relative to 100 parts by weight of the roasted licorice root, the content of the Radix Trichosanthis is 115-135 parts by weight, the content of the dried ginger is 35-55 parts by weight, the content of the Atractylodes macrocephala is 145-165 parts by weight, the content of the Peucedanum peucedanum is 55-70 parts by weight, the content of the Platycodon grandiflorum is 115-130 parts by weight, the content of the Sophora flavescens is 85-100 parts by weight, the content of the Phellodendron chinense is 55-70 parts by weight, the content of the Fritillaria thunbergii is 125-150 parts by weight, the content of the Anemarrhena asphodeloides is 85-100 parts by weight, the content of the Gardenia jasminoides is 115-130 parts by weight, the content of the Morus alba bark is 145-165 parts by weight, and the content of the Scutellaria baicalensis is 145-160 parts by weight.

[0015] Further, relative to 100 parts by weight of the roasted licorice root, the content of the Radix Trichosanthis is 116±1 parts by weight, the content of the dried ginger is 35±1 parts by weight, the content of the Atractylodes macrocephala is 145±1 parts by weight, the content of the Peucedanum peucedanum is 65±1 parts by weight, the content of the Platycodon grandiflorum is 116±1 parts by weight, the content of the Sophora flavescens is 85±1 parts by weight, the content of the Phellodendron chinense is 65±1 parts by weight, the content of the Fritillaria thunbergii is 126±1 parts by weight, the content of the Anemarrhena asphodeloides is 85±1 parts by weight, the content of the Gardenia jasminoides is 115±1 parts by weight, the content of the Morus alba bark is 145±1 parts by weight, and the content of the Scutellaria baicalensis is 145±1 parts by weight.

[0016] The preparation method of the traditional Chinese medicine composition as described above is prepared by mixing various components uniformly, and the mixing conditions are as long as the active components can be mixed uniformly.

[0017] Use of the above-mentioned Chinese medicine composition in preparing medicine for preventing and treating cough caused by phlegm-heat blocking the lungs.

[0018] A medicament for preventing and treating phlegm-heat blocking lung type cough using the above-mentioned traditional Chinese medicine composition, the medicament contains active components and auxiliary materials, and the active components contain the traditional Chinese medicine composition.

[0019] Further, based on the total weight of the medicament, the content of the active ingredient is 20-80% by weight, preferably 40-70% by weight, and exemplarily 45%, 50%, 55%, 60%, 65%, 70%, or 75% by weight.

[0020] The auxiliary materials in the medicament of the present invention can be auxiliary materials commonly used in traditional Chinese medicine preparations.

[0021] Furthermore, in order to obtain a medicament with more stable efficacy, the auxiliary material is selected from at least one of starch, dextrin, powdered sugar, calcium carbonate, calcium phosphate and microcrystalline cellulose; more preferably, the auxiliary material is at least one of starch and dextrin.

[0022] Alternatively, the dosage form of the drug is a capsule, a pill, a paste, a pill or a tablet; more preferably, the drug is at least one of a pill, a capsule and a tablet, and further preferably a capsule.

[0023] A capsule for preventing and treating cough of phlegm-heat blocking the lungs using the Chinese medicine composition as described above, wherein the capsule contains 50-80% by weight of the Chinese medicine composition as an active ingredient, and the excipients in the capsule are at least one of starch, dextrin, powdered sugar, calcium carbonate, calcium phosphate, microcrystalline cellulose, mannitol, vegetable oil, gelatin, polyethylene glycol, stevioside, and magnesium stearate; and the average particle size of the active ingredient is 120-355 μm.

[0024] The preparation method of the capsule of the present invention is not particularly limited, and can be a conventional capsule preparation process in the art, such as directly packaging the powder of the medicinal material or the granules or powder after extraction into hollow capsules to prepare the preparation.

[0025] Illustratively, the capsule can be prepared by sterilizing the granules and then filling them into hollow capsules.

[0026] The advantages and positive effects achieved by the present invention are:

[0027] 1. The present invention provides a Chinese medicine composition for treating phlegm-heat blocking lung type cough with stable preparation quality, definite efficacy, safety and effectiveness according to the theory of traditional Chinese medicine, so as to solve the problem of early recovery of patients with phlegm-heat blocking lung type cough. The medicine is made of common Chinese medicine as raw materials, and through reasonable formulation and compatibility, it can effectively treat the cough caused by phlegm-heat blocking lung and the purpose of yellow and sticky sputum.

[0028] 2. The inventor follows the traditional theory of Chinese medicine, and through the compatibility of monarch, minister, assistant and envoy, the curative effect is improved after the addition of each medicine, and good clinical feedback is produced. The weight ratio of the dosage of the Chinese medicinal materials in the prescription is screened for a long time and a large number of drug efficacy experiments, and the prescription ratio and dosage of the present invention are finally determined. The experiment proves that the prescription composition and dosage range of the present invention are reasonably compatible, the curative effect is definite, and it has the effects of dispersing the lungs and relieving the exterior, relieving cough and reducing phlegm. It has a unique curative effect for treating phlegm-heat blocking the lung type cough.

[0029] 3. The lung-clearing and phlegm-resolving preparation of the present invention is a product for treating cough caused by phlegm-heat blocking the lungs, and has the functions of clearing the lungs, relieving cough and resolving phlegm. It is used for cough caused by phlegm-heat blocking the lungs. This disease has received good results in clinical applications. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 The morphological and histological changes (hematoxylin-eosin (HE) staining) of the main organs of the four groups of rats in the present invention;

[0031] Figure 2This is the identification diagram of Scutellaria baicalensis in the present invention; wherein, sample 1, sample 2, and sample 3 are three parallel groups of samples;

[0032] Figure 3 This is the identification diagram of Gardenia jasminoides in the present invention; wherein, Sample 1 and Sample 2 are two parallel groups of samples;

[0033] Figure 4 This is a diagram for identifying matrine in the present invention;

[0034] Figure 5 It is the high performance liquid chromatogram of Scutellaria baicalensis in the present invention. DETAILED DESCRIPTION

[0035] The present invention will be further described below in conjunction with the embodiments. The following embodiments are descriptive rather than restrictive, and the protection scope of the present invention cannot be limited by the following embodiments.

[0036] The various experimental operations involved in the specific embodiments are all routine techniques in the art. For parts not specially annotated in this document, ordinary technicians in the art can implement them by referring to various commonly used reference books, scientific and technological literature or related instructions, manuals, etc. before the filing date of this invention.

[0037] A Chinese medicine composition for preventing and treating phlegm-heat blocking lung type cough, the Chinese medicine composition contains effective amounts of two or more main drugs, ministerial drugs, adjuvant drugs and guiding drugs stored in a mixed or separate manner, wherein:

[0038] The monarch drugs include: Scutellaria baicalensis and Morus alba bark;

[0039] The ministerial drugs include: Phellodendron amurense, Gardenia jasminoides, and Fritillaria thunbergii;

[0040] The adjuvants include: Platycodon grandiflorum, Peucedanum chinense, Sophora flavescens, Rhizoma Anemarrhenae, Atractylodes macrocephala, Radix Trichosanthis, and dried ginger;

[0041] The adjuvant drug includes: roasted licorice root.

[0042] Preferably, in the traditional Chinese medicine composition, compared to 100 parts by weight of the roasted liquorice root, the content of the Radix Trichosanthis is 110-140 parts by weight, the content of the dried ginger is 30-60 parts by weight, the content of the Atractylodes macrocephala is 140-170 parts by weight, the content of the Peucedanum peucedanum is 45-75 parts by weight, the content of the Platycodon grandiflorum is 110-140 parts by weight, the content of the Sophora flavescens is 80-110 parts by weight, the content of the Phellodendron chinense is 45-75 parts by weight, the content of the Fritillaria thunbergii is 120-160 parts by weight, the content of the Anemarrhena asphodeloides is 80-110 parts by weight, the content of the Gardenia jasminoides is 110-140 parts by weight, the content of the Morus alba bark is 140-170 parts by weight, and the content of the Scutellaria baicalensis is 140-170 parts by weight.

[0043] Preferably, relative to 100 parts by weight of the roasted licorice root, the content of the Radix Trichosanthis is 115-135 parts by weight, the content of the dried ginger is 35-55 parts by weight, the content of the Atractylodes macrocephala is 145-165 parts by weight, the content of the Peucedanum peucedanum is 55-70 parts by weight, the content of the Platycodon grandiflorum is 115-130 parts by weight, the content of the Sophora flavescens is 85-100 parts by weight, the content of the Phellodendron chinense is 55-70 parts by weight, the content of the Fritillaria thunbergii is 125-150 parts by weight, the content of the Anemarrhena asphodeloides is 85-100 parts by weight, the content of the Gardenia jasminoides is 115-130 parts by weight, the content of the Morus alba bark is 145-165 parts by weight, and the content of the Scutellaria baicalensis is 145-160 parts by weight.

[0044] Preferably, relative to 100 parts by weight of the roasted liquorice, the content of the Radix Trichosanthis is 116±1 parts by weight, the content of the dried ginger is 35±1 parts by weight, the content of the Atractylodes macrocephala is 145±1 parts by weight, the content of the Peucedanum peucedanum is 65±1 parts by weight, the content of the Platycodon grandiflorum is 116±1 parts by weight, the content of the Sophora flavescens is 85±1 parts by weight, the content of the Phellodendron chinense is 65±1 parts by weight, the content of the Fritillaria thunbergii is 126±1 parts by weight, the content of the Anemarrhena asphodeloides is 85±1 parts by weight, the content of the Gardenia jasminoides is 115±1 parts by weight, the content of the Morus alba bark is 145±1 parts by weight, and the content of the Scutellaria baicalensis is 145±1 parts by weight.

[0045] The preparation method of the traditional Chinese medicine composition as described above is prepared by mixing various components uniformly, and the mixing conditions are as long as the active components can be mixed uniformly.

[0046] Use of the above-mentioned Chinese medicine composition in preparing medicine for preventing and treating cough caused by phlegm-heat blocking the lungs.

[0047] A medicament for preventing and treating phlegm-heat blocking lung type cough using the above-mentioned traditional Chinese medicine composition, the medicament contains active components and auxiliary materials, and the active components contain the traditional Chinese medicine composition.

[0048] Preferably, based on the total weight of the medicament, the content of the active ingredient is 20-80% by weight, preferably 40-70% by weight, and exemplarily 45%, 50%, 55%, 60%, 65%, 70%, or 75% by weight.

[0049] The auxiliary materials in the medicament of the present invention can be auxiliary materials commonly used in traditional Chinese medicine preparations.

[0050] Preferably, in order to obtain a medicament with more stable efficacy, the excipient is selected from at least one of starch, dextrin, powdered sugar, calcium carbonate, calcium phosphate and microcrystalline cellulose; more preferably, the excipient is at least one of starch and dextrin.

[0051] Alternatively, the dosage form of the drug is a capsule, a pill, a paste, a pill or a tablet; more preferably, the drug is at least one of a pill, a capsule and a tablet, and further preferably a capsule.

[0052] A capsule for preventing and treating cough of phlegm-heat blocking the lungs, using the above-mentioned traditional Chinese medicine composition, wherein the capsule contains 50-80% by weight of the traditional Chinese medicine composition as an active component, and the auxiliary materials in the capsule are at least one of starch, dextrin, powdered sugar, calcium carbonate, calcium phosphate and microcrystalline cellulose, mannitol, vegetable oil, gelatin, polyethylene glycol, stevioside, and magnesium stearate; and the average particle size of the active component is 120-355 μm.

[0053] The preparation method of the capsule of the present invention is not particularly limited, and can be a conventional capsule preparation process in the art, such as directly packaging the powder of the medicinal material or the granules or powder after extraction into hollow capsules to prepare the preparation.

[0054] Illustratively, the capsule can be prepared by sterilizing the granules and then filling them into a capsule shell.

[0055] Specifically, the relevant preparation and detection are as follows:

[0056] The raw materials and equipment used in the specific embodiments of the present invention are all known products, which are obtained by purchasing commercial products. Among them, the preparation process of tablets, granules, capsules, pills, dripping pills and mixtures made from the Chinese medicine composition of the present invention is mature.

[0057] Embodiment 1:

[0058] The preparation method of the tablet, hard capsule and pill of the present invention:

[0059] 110-140 parts of Radix Trichosanthis, 30-60 parts of dried ginger, 140-170 parts of Atractylodes macrocephala, 45-75g parts of Peucedanum, 110-140 parts of Platycodon grandiflorum, 80-110 parts of Sophora flavescens, 45-75 parts of Phellodendron amurense, 120-160 parts of Fritillaria thunbergii, 80-110 parts of Rhizoma Anemarrhenae, 110-140 parts of Gardenia jasminoides, 140-170 parts of Cortex Mori, and 140-170 parts of Radix Scutellariae;

[0060] The above parts are all parts by weight.

[0061] Preparation method:

[0062] Take Fritillaria thunbergii, Peucedanum chinense, and Atractylodes macrocephala and grind them into fine powder for later use. Add water to the remaining 9 ingredients including Scutellaria baicalensis and boil them twice, each time for 1.5 hours. Combine the decoctions, filter, and concentrate the filtrate to a relative density of 1.25-1.30 g / cm 3(55°C), add the above-mentioned fine powder, stir evenly, dry below 80°C, make granules, mix evenly, put into capsules, and make capsules; or add 3.0g of magnesium stearate and 100.0g of mannitol to press into tablets to make tablets; or make into pills.

[0063] Embodiment 2:

[0064] Preparation method of soft capsule, dripping pill and mixture of the present invention

[0065] 120-130 parts of Radix Trichosanthis, 40-50 parts of dried ginger, 150-160 parts of Atractylodes macrocephala, 50-70 parts of Peucedanum, 120-130 parts of Platycodon grandiflorum, 90-100 parts of Sophora flavescens, 50-70 parts of Phellodendron amurense, 130-150 parts of Fritillaria thunbergii, 90-100 parts of Rhizoma Anemarrhenae, 120-130 parts of Gardenia jasminoides, 150-160 parts of Cortex Mori, and 150-160 parts of Radix Scutellariae;

[0066] The above parts are all parts by weight.

[0067] Preparation method:

[0068] Take 12 herbs including Fritillaria thunbergii, Peucedanum chinense, Phellodendron amurense, etc., add water and boil twice, each time for 2 hours, combine the decoctions, filter, and concentrate the filtrate to a relative density of 1.30-1.32g / cm 3 (60℃), spray dry, add appropriate amount of vegetable oil, and prepare gelatin solution according to a certain prescription for use. Control appropriate conditions, adjust the weight of the contents, and make soft capsules in a soft capsule machine. Or add appropriate amount of polyethylene glycol 6000, heat and melt, mix well, and make dripping pills. Or concentrate the above extract to a relative density of 1.1g / cm 3 (60℃), add appropriate amount of sucrose to make a mixture.

[0069] Example 3

[0070] The preparation method of the chewable tablet and granule of the present invention:

[0071] 105-145 parts of Radix Trichosanthis, 25-65 parts of dried ginger, 135-175 parts of Atractylodes macrocephala, 40-80g parts of Peucedanum, 105-145 parts of Platycodon grandiflorum, 75-115 parts of Sophora flavescens, 40-80 parts of Phellodendron amurense, 115-165 parts of Fritillaria thunbergii, 75-115 parts of Rhizoma Anemarrhenae, 105-145 parts of Gardenia jasminoides, 135-175 parts of Cortex Mori, and 135-175 parts of Radix Scutellariae;

[0072] The above parts are all parts by weight.

[0073] Preparation method:

[0074] Take 12 herbs including Fritillaria thunbergii, Scutellaria baicalensis, Atractylodes macrocephala, etc. and boil them twice, each time for 1 hour, combine the decoctions, filter, and concentrate the filtrate to a relative density of 1.15-1.30 g / cm3 (55℃), spray dry, add appropriate amount of mannitol and stevioside, mix evenly, granulate, dry, add appropriate amount of magnesium stearate, press into chewable tablets. Or add appropriate amount of sucrose and dextrin to the above extract to make granules.

[0075] The Chinese medicine composition for treating phlegm-heat blocking lung type cough of the present invention is further described below through the main pharmacodynamics research:

[0076] 1. Analysis of the relationship between pharmacology, medicinal properties and efficacy of Chinese medicine compositions

[0077] Scutellaria baicalensis, this product is conical, twisted, 8-25cm long, 1-3cm in diameter. The surface is brown or dark yellow, bitter and cold, and it belongs to the lung, gallbladder, spleen, large intestine and small intestine meridians. Indications: clearing heat and dampness, purging fire and detoxifying, used for lung heat cough. Its active ingredients baicalein and baicalin can adjust mitochondrial cell apoptosis, inhibit the conduction of inflammatory transmitters, improve the expression level of cyclooxygenase, accelerate the apoptosis of senescent cells, and play an anti-inflammatory role.

[0078] Morus alba bark, this product is the dried root bark of Morus alba L., a plant of the Moraceae family. It tastes sweet and cold and enters the lung meridian. It mainly purges the lungs and relieves asthma, promotes diuresis and reduces swelling. It is used for cough and asthma caused by lung heat. Extracted Morus alba bark polysaccharide can reduce the infiltration of inflammatory cells in the alveolar wall, downregulate the production of inflammatory factors, inhibit the production of nitric oxide and nitric oxide synthase, inhibit the expression of cyclooxygenase 2, and exert anti-inflammatory effects. Multiple components have antitussive, expectorant, and asthma-relieving effects.

[0079] Phellodendron chinense, this product is in the form of plates or shallow grooves, with different lengths and widths, and a thickness of 1-6mm. The outer surface is yellow-brown or yellow-brown, flat or with longitudinal grooves, and some have visible lenticel marks and residual gray-brown rough skin. It can clear away heat and dampness, purge fire and remove steam. It is used for yin deficiency and hyperactivity of fire, night sweats and bone steaming. The active ingredients mainly include alkaloids, phenolic acids, limonoids, phenylpropanoids, terpenes, etc. Its pharmacological effects include anti-inflammatory, antibacterial, anti-cancer, hypoglycemic, and protection of the liver and kidneys.

[0080] Gardenia, a plant of the Rubiaceae family. It tastes bitter and cold, and enters the heart, lung, and triple burner meridians. It is used for restlessness due to fever, jaundice due to dampness and heat, painful stranguria due to stranguria, vomiting and bleeding due to blood heat, red and swollen eyes, and fire poison sores; it is also used for external treatment of sprains and contusions. The main ingredients are gardenia glycoside, ursolic acid, and other water-soluble ingredients. Gardenia glycoside is a typical anti-inflammatory product. It has antipyretic, anti-inflammatory, sedative, antihypertensive, and lipid-regulating pharmacological effects.

[0081] Zhejiang Fritillaria has pharmacological effects such as expectorant, antitussive, antiasthmatic, anti-inflammatory, antibacterial, analgesic, antioxidant, anti-cancer and anti-tumor. The active ingredients are mainly alkaloids such as Fritillaria suspensa A and Fritillaria suspensa B. Zhejiang Fritillaria suspensa is often used in combination with traditional Chinese medicine to exert a synergistic effect and is beneficial to the treatment of diseases.

[0082] Platycodon grandiflorum, the dried root of the plant Platycodon grandiflorum of the Campanulaceae family. It tastes bitter, pungent and flat, and enters the lung meridian. Indications: clearing the lungs, relieving sore throat, removing phlegm, and draining pus. It is used for cough with a lot of phlegm, chest tightness, sore throat and hoarseness, and lung abscess with vomiting pus. The effective ingredients of Platycodon grandiflorum, Platycodon polyphenols and Platycodon polysaccharides, can reduce endogenous oxidative damage, inhibit the expression of cyclooxygenase, enhance the ability to scavenge oxygen free radicals, and exert antioxidant and anti-inflammatory effects.

[0083] Peucedanum chinense is the dried root of the plant Peucedanum chinense of the Umbelliferae family. It tastes bitter and pungent, slightly cold. It enters the lung meridian. Indications: descending qi and resolving phlegm, dispersing wind and clearing heat. It is used for wheezing due to phlegm-heat, coughing with yellow and thick phlegm, and coughing with wind-heat and excessive phlegm.

[0084] Sophora flavescens, the dried root of the plant Sophora flavescens Ait. of the Leguminosae family. It tastes bitter and cold, and enters the heart, liver, stomach, large intestine, and bladder meridians. Indications: clearing away heat and dampness, killing insects, and promoting diuresis. It is used for heat dysentery, blood in stool, jaundice and urine retention, leucorrhea, swelling and itching of the genitals, eczema, wet sores, itchy skin, scabies and leprosy.

[0085] Anemarrhena asphodeloides Bge. is a dried rhizome of the Liliaceae plant. It tastes bitter, sweet and cold, and enters the lung, stomach and kidney meridians. It is used for exogenous febrile diseases, high fever and thirst, lung heat and dry cough, bone steaming and tidal fever, internal heat and thirst, and dry intestinal constipation.

[0086] Atractylodes macrocephala is the dried rhizome of Atractylodes macrocephala Koidz. of the Asteraceae family. It tastes bitter, sweet and warm. It enters the spleen and stomach meridians. Indications: invigorating the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. It is used for spleen deficiency, poor appetite, abdominal distension and diarrhea, phlegm and fluid, dizziness and palpitations, edema, spontaneous sweating, and restless fetuses.

[0087] Ephedra, a plant of the genus Ephedra in the family Ephedraceae, is mainly used to induce sweating and relieve exterior symptoms, promote lung function and relieve asthma, and promote diuresis and reduce swelling.

[0088] Codonopsis pilosula, the dried root of Codonopsis pilosula, Codonopsis pilosula, or Codonopsis pilosula of the Campanulaceae family, is used to treat weak spleen and stomach, deficiency of qi and blood, fatigue, poor appetite, thirst, chronic diarrhea, and prolapse of the anus.

[0089] Radix Trichosanthis, the dried root of the plant Trichosanthis or Trichosanthis bilateralis of the Cucurbitaceae family. It tastes sweet, slightly bitter, and slightly cold. It enters the lung and stomach meridians. Indications: clearing away heat and purging fire, promoting the production of body fluids and relieving thirst, reducing swelling and draining pus. It is used for fever, thirst, lung heat and dry cough, internal heat and thirst, and sores and swelling.

[0090] Dried ginger is the dried rhizome of ginger, a plant of the ginger family. It tastes spicy and hot. It enters the spleen, stomach, kidney, heart and lung meridians. Indications: warming the middle and dispersing cold, restoring yang and unblocking meridians, warming the lungs and transforming fluid. It is used for cold pain in the abdomen, vomiting and diarrhea, cold limbs and weak pulse, asthma and cough due to cold fluid.

[0091] Roasted licorice is a plant of the leguminous family. Roasted licorice is licorice roasted with honey. It has the effects of nourishing yin and blood, invigorating qi and promoting yang, restoring pulse and calming palpitations. It is mainly used to treat deficiency of both yin and yang in the heart.

[0092] The above raw materials can be processed products purchased in the market, or can be obtained by a processing method known in the art, for example, by drying and grinding the raw materials, and crushing them into powders commonly used in this field. The drying method can be drying or natural sun drying, preferably drying. The grinding method can be a conventional method of grinding or crushing Chinese medicine into powder in the field of traditional Chinese medicine, and the grinding conditions are preferably such that the average particle size of the raw materials is 120um-180um, more preferably 140-160um.

[0093] The functional relationship between the principal drug, the ministerial drug, the adjuvant drug and the guiding drug in the aforementioned traditional Chinese medicine composition provided by the present invention is analyzed as follows:

[0094] Phlegm-heat blocking lung syndrome cough is also called phlegm-heat blocking lung syndrome cough. This syndrome is caused by exogenous pathogens invading the lungs, which turns into heat, and the heat damages the lung fluid, and the fluid turns into phlegm, or there is old phlegm, and the wind-heat causes phlegm and heat to form. The treatment should be to clear the lungs and resolve phlegm, stop cough and relieve asthma. In the prescription, Scutellaria baicalensis is bitter and cold, and it belongs to the lung and large intestine meridians. It is good at ascending to clear the heat of the upper jiao, clear the lung fire and the fire of the large intestine. Morus alba bark is sweet and cold in nature and enters the lung meridian, drains the lungs and relieves asthma, and promotes water and reduces swelling. It is specially used to drain lung fire to relieve asthma, and promotes water and fluid to reduce swelling. Therefore, it can be used for all symptoms such as lung heat cough and asthma, vomiting blood, and edema and fullness caused by lung qi stagnation, and urination difficulties. Scutellaria baicalensis must be used to drain fire and Morus alba bark. The two are complementary and compatible, and they are used to treat lung heat cough, wheezing, sputum, and yellow sputum. Gardenia jasminoides is bitter and cold, and enters the heart, liver, lung, stomach, and triple burner meridians. It clears away heat and purges fire, and has a slow downward nature. It can clear the fire of the heart, lungs and three energizers and promote urination. Therefore, it can purge fire and relieve restlessness, purge heat and promote dampness, and has the effect of cooling blood and stopping bleeding. Therefore, it is an important medicine for all febrile diseases, heat accumulation in the chest and diaphragm, or heat stagnation in the blood, as well as damp-heat accumulation. Phellodendron chinense is bitter and cold, clears heat, dispels dampness and purges fire, and is bitter and cold and descends. It is good at purging the fire of the kidney and clearing damp-heat in the lower energizer. Fritillaria thunbergii is bitter and cold, clears the lungs and stops coughs, resolves phlegm and disperses stagnation, and opens and clears lung qi. It is used for coughs caused by exogenous wind evil and phlegm-heat stagnation in the lungs. The above medicines are all ministerial medicines; Platycodon grandiflorum is bitter, cold, and neutral, and enters the lung meridian. It can clear the lungs and relieve cough, clear the lungs and resolve phlegm, relieve sore throat and reduce swelling; Peucedanum chinense is bitter, pungent and slightly cold, dispels wind and clears the lungs, descends qi and resolves phlegm, and is an important medicine for dispersing wind-heat and treating cough; Sophora flavescens is bitter and cold, enters the heart, spleen and kidney meridians, clears heat, dries dampness and detoxifies, and can clear the heat of the three burners when combined with Scutellaria baicalensis, Phellodendron chinense and Gardenia jasminoides; Anemarrhena asphodeloides and Radix Trichosanthis can not only clear the lungs and moisten dryness, but also nourish yin, produce essence and quench thirst; Atractylodes macrocephala can replenish qi and strengthen the spleen, and dried ginger warms the lungs and resolves cold, and relieves cough, so as to reconcile the disadvantages of bitterness and coldness, and they are all adjuvants. All the medicines are used together to achieve the effect of clearing the lungs and resolving phlegm, relieving cough and relieving asthma.

[0095] 2. Pharmacodynamics and toxicology studies of Chinese medicine compositions

[0096] In order to verify the clinical feasibility, efficacy and toxic side effects of the composition, the present invention conducted a main pharmacodynamic and toxicological study on the composition to provide an experimental basis for clinical practice. Pharmacodynamic and toxicological study of the Chinese medicine composition of the present invention.

[0097] (I) Pharmacodynamics study of Chinese medicine compositions

[0098] Preparation of test samples: according to Example 3, 105-145 parts of Radix Trichosanthis, 25-65 parts of dried ginger, 135-175 parts of Atractylodes macrocephala, 40-80g parts of Peucedanum, 105-145 parts of Platycodon grandiflorum, 75-115 parts of Sophora flavescens, 40-80 parts of Phellodendron amurense, 115-165 parts of Fritillaria thunbergii, 75-115 parts of Rhizoma Anemarrhenae, 105-145 parts of Gardenia jasminoides, 135-175 parts of Morus alba and 135-175 parts of Scutellaria baicalensis;

[0099] The above parts are all parts by weight.

[0100] High-dose group: Radix Trichosanthis 145 parts, dried ginger 65 parts, Atractylodes macrocephala 175 parts, Peucedanum 80g parts, Platycodon grandiflorum 145 parts, Sophora flavescens 115 parts, Phellodendron amurense 80 parts, Fritillaria thunbergii 165 parts, Rhizoma Anemarrhenae 115 parts, Fructus Gardeniae 145 parts, Cortex Mori 175 parts, Scutellaria baicalensis 175 parts;

[0101] Medium dose group: Radix Trichosanthis 125 parts, dried ginger 45 parts, Atractylodes macrocephala 155 parts, Peucedanum 60g parts, Platycodon grandiflorum 135 parts, Sophora flavescens 105 parts, Phellodendron amurense 60 parts, Fritillaria thunbergii 145 parts, Rhizoma Anemarrhenae 95 parts, Fructus Gardeniae 125 parts, Cortex Mori 155 parts, Scutellaria baicalensis 155 parts;

[0102] Low-dose group: Radix Trichosanthis 105 parts, dried ginger 25 parts, Atractylodes macrocephala 135 parts, Peucedanum 40g parts, Platycodon grandiflorum 105 parts, Sophora flavescens 75 parts, Phellodendron amurense 40 parts, Fritillaria thunbergii 115 parts, Rhizoma Anemarrhenae 75 parts, Fructus Gardeniae 105 parts, Cortex Mori 135 parts, Radix Scutellariae 135 parts;

[0103] Comparative ratio: 145 parts of Radix Trichosanthis, 25 parts of dried ginger, 135 parts of Atractylodes macrocephala, 40g of Peucedanum, 105 parts of Platycodon grandiflorum, 75 parts of Sophora flavescens, 40 parts of Phellodendron amurense, and 115 parts of Fritillaria thunbergii;

[0104] The above parts are all parts by weight.

[0105] Common preparation method:

[0106] Take 12 herbs including Fritillaria thunbergii, Scutellaria baicalensis, Atractylodes macrocephala, etc. and boil them twice, each time for 1 hour, combine the decoctions, filter, and concentrate the filtrate to a relative density of 1.15-1.30 g / cm 3 (55℃), spray-dry, add appropriate amount of sucrose, dextrin and stevioside to the extract to make granules.

[0107] Experiment 1: Antitussive effect of different preparations on mice

[0108] 1.1 Experimental Materials

[0109] (1) Grouping: 50 female SPF NIH mice weighing 17-21 g were randomly divided into 5 groups, namely, normal group, high-dose group, medium-dose group, low-dose group, and positive drug group.

[0110] (2) Administration: The mice in the high, medium and low dose groups were administered with aqueous solutions of the samples prepared in the corresponding embodiments or comparative examples. The dosage of the high dose group was 2.90 g of crude drug / kg mouse, the dosage of the medium dose group was 2.06 g of crude drug / kg mouse, and the dosage of the low dose group was 2.05 g of crude drug / kg mouse. The positive drug group was administered with dextromethorphan (15 mg per tablet, two tablets were dissolved in warm water to obtain a suspension) (the dosage of dextromethorphan was 2.05 g-2.07 g of crude drug / kg mouse), and the mice in the normal group were administered with the same dosage of warm water as the high dose group.

[0111] 1.2 Experimental method: One hour after the mice were gavaged with the drug according to 1.1 above, the concentrated ammonia spray method was used to induce coughing. A cotton ball with 0.5 mL of concentrated ammonia was covered with a screen, and a 500 mL beaker was inverted to cover the cotton ball and the mouse at the same time, so that the ammonia stimulation induced the mouse to cough, and the coughing reaction was observed. The number of coughs within one minute, if there were more than 3 typical coughing movements within 1 minute (abdominal muscle contraction or chest shrinkage, open mouth at the same time, sometimes there may be coughing sounds), it was "coughing", the model was successfully established, and the mice were taken out. According to the statistical method, the effective amount and R value were calculated, where R value = (EDT50 of the drug group / EDT50 of the control group) * 100%. If the R value > 130, there is an antitussive effect; if the drug R value > 150, there is a significant antitussive effect.

[0112] 1.3 Scoring Criteria

[0113] 3 points: large and frequent contractions of the abdomen and lungs, with frequent coughing;

[0114] 2 points: abdomen and lungs contract widely but infrequently, heavy breathing;

[0115] 1 point: The abdomen and lungs contract slightly, infrequently, and the breathing is light;

[0116] 0 points: None of the above situations

[0117] 1.4 Experimental results The experimental results are shown in Table 1.

[0118] Table 1 Observation scores of different prescription dosage preparations on antitussive effects in mice

[0119]

[0120]

[0121] (Note: Compared with the blank group, *P<0.05, **P<0.01)

[0122] Compared with the control group, the antitussive effect of the high, medium and low dose groups on mice by intragastric administration was significantly increased, and there was a statistically significant difference; compared with the positive drug control, the antitussive effect of the high dose group of the embodiment on mice was significantly increased, and there was a statistically significant difference. This preparation has a more obvious antitussive effect.

[0123] Experiment 2: Experiment on the expectorant effect of different dosage preparations on mice

[0124] 1.1 Experimental Materials

[0125] Animals: Male SPF-grade NIH mice weighing 17-21 g. Randomly divided into 5 groups, namely normal group, high-dose group, medium-dose group, low-dose group, and positive drug group. Administration: The mice in the high, medium, and low groups were given an aqueous solution of the sample prepared in the corresponding embodiment or comparative example, with a dose of 2.90 g crude drug / kg; the positive drug group was given a suspension of Tankejing powder (0.2 g was dissolved in warm water, and the dosage of Tankejing powder was 2.05 g-2.07 g crude drug / kg mouse), with a dose of 0.2 g / kg, and the mice in the normal group were given warm water of the same dose as the high dose.

[0126] 1.2 Experimental methods

[0127] (1) The mice were fasted for 12 hours but not water, and then gavaged according to the above 1.1 “Administration” method. In order of animal number, each mouse was gavaged for 3 minutes, and then another mouse was gavaged, with an interval of 3 minutes. The total gavage time for each group of 10 mice was 30 minutes.

[0128] (2) Half an hour after gavage, each mouse was intraperitoneally injected with 0.2 ml of 5% phenol red saline solution. In order, 3 minutes after each mouse was intraperitoneally injected with phenol red, another mouse was injected, and the total time for 10 mice was 30 minutes.

[0129] (3) Half an hour after the intraperitoneal injection of each mouse, the mice were killed in sequence by dislocating the cervical vertebrae, with an interval of 3 minutes between killings. After the animals were killed, they were fixed on the operating board in a supine position, the skin in the middle of the neck was cut, the trachea was separated, and the trachea was supported with small tweezers. A large syringe was used to absorb physiological saline to flush the outer wall of the trachea, wash away the blood and phenol red in the outer wall of the trachea, and the washing liquid was absorbed by filter paper. First, the trachea was cut at the tracheal branch, and then the trachea was cut at the upper end of the thyroid cartilage at the other end (including the cricoid cartilage). Each tracheal segment was placed in a test tube pre-filled with 1.5 ml of 5% NaHCO3 solution. The above tracheal separation and shearing work was completed within 3 minutes.

[0130] (4) Each test tube was placed on a vortex mixer for 2 minutes to release the phenol red in the tracheal segment. The OD value of the solution in each test tube was measured at 546 nm on a 721 spectrophotometer.

[0131] (5) Place each test tube containing the tracheal segment overnight and re-measure the OD value after 24 hours.

[0132] (6) Phenol red was prepared into aqueous solutions with different contents, and the OD value was measured, and the regression equation was calculated as: Y = -0.135302794 + 14.19137583X. The linear range was 0.1 ng / ml to 10 ng / ml (r = 0.9999; X is the OD value, Y is the phenol red content), and the tracheal phenol red excretion (phenol red content) of each of the above animals was calculated according to the regression equation.

[0133] (7) SPSS14.0 statistical software was used for variance analysis. The results are shown in Table 2.

[0134] 1.3 Experimental Results

[0135] Table 2 The expectorant effect of different dosage preparations on mice

[0136]

[0137] (Note: expectoration rate = drug group / normal group × 100%; calculation method of phenol red content (nanograms): OD value × 14.19137583-0.135302794. Compared with the blank normal group, *P<0.05, **P<0.01)

[0138] Compared with the control group, the increase in bronchial secretion of mice by oral administration of high, medium and low dose groups was significantly increased, and there was a statistically significant difference; compared with the positive drug control, the high and medium dose groups of the embodiment had a significant increase in bronchial secretion of mice, and there was a statistically significant difference. This preparation has a more obvious expectorant effect, but the effect of the low dose group is slightly worse, and the high and medium dose groups can be preferably used.

[0139] In summary, it can be seen from the pharmacodynamics experiment that the prescription of the present invention has a significant inhibitory effect on acute pharyngitis and cough in rats caused by ammonia, and can significantly increase the secretion of mouse bronchial fluid, wherein the high-dose group has the best effect, followed by the medium-dose group, and the effect is better than the commercially recognized positive drugs. The comparative example adopts unreasonable addition and replacement of prescriptions, and adopts unreasonable disassembly of prescriptions, which improves symptoms, relieves cough and reduces phlegm, and has weaker effects than the prescription of the present invention. The prescription of the present invention has good compatibility of medicinal flavors, and the compatibility of monarch, minister, assistant and envoy is accurate. The combination of various medicines can significantly synergistically exert the good effects of nourishing yin and moistening the lungs, promoting body fluid and relieving cough, and clearing and relieving throat, and has good clinical and daily life application value.

[0140] (II) Toxicological studies on Chinese medicine compositions

[0141] 2.1 Experimental drugs and preparation

[0142] The experimental drug is a lung-clearing and phlegm-resolving preparation provided by our company's technical development department. It is prepared into a suspension with distilled water before use and is prepared into a maximum concentration of 7.38 g / mL based on the raw drug amount.

[0143] 2.1.1 Main reagents

[0144] Total bilirubin (TBIL) kit (catalog number: 70502), albumin (ALB) kit (catalog number: 70343), total protein (TP) kit (catalog number: 70112), aspartate aminotransferase (AST) kit (catalog number: 70340), alanine aminotransferase (ALT) kit (catalog number: 74011), total cholesterol (TC) kit (catalog number: 73501), triglyceride (TG) kit (catalog number: 70202) were all purchased from Shandong Bo Ke Biological Industry Co., Ltd.; creatinine (Cr ) Colorimetric test kit (catalog number: E-BC-K185-M), urea nitrogen (BUN) colorimetric test kit (catalog number: E-BC-K138-M), and urea nitrogen (BUN) colorimetric test kit (catalog number: E-BC-K143-M) were all purchased from Wuhan Elerite Biotechnology Co., Ltd.; hematoxylin staining solution (Beijing Zhongshan Jinqiao Biotechnology Co., Ltd., catalog number: ZLI-9610); Scott blueing solution (catalog number: G1845) and eosin staining solution (catalog number: G1330) were all purchased from Beijing Solebow Technology Co., Ltd.

[0145] 2.1.2 Main instruments

[0146] Blood analyzer (Shenzhen Jinrui Biotechnology Co., Ltd.); blood glucose tester (Roche, Switzerland); automatic tissue dehydrator (Kedi Instrument Equipment Co., Ltd., Jinhua City, Zhejiang Province); paraffin embedding machine, slicer, and slide spreader were all purchased from Leica, Germany; biological microscope (Olympus Corporation, Japan).

[0147] 2.2.1 Acute toxicity test

[0148] SPF Kunming mice were randomly divided into a control group and a drug-treated group. The two groups of rats were fasted for 4 hours before the experiment. The maximum tolerated dose method was used. The drug-treated group was given a single oral gavage of 20 mL / kg, and a single gavage of 127.6 g / kg of the Qingfei Huatan content suspension was given. The control group was given an equal volume of distilled water. The animals were observed for 14 consecutive days, and the animals were killed to obtain important organs such as the heart, liver, kidney, stomach, and duodenum. The changes in their size, morphology, color, and texture were observed, and the death of the mice was recorded.

[0149] 2.2.2 Subacute toxicity test

[0150] SPF SD rats were divided into male and female groups according to gender, 40 in each group. The male and female groups were randomly divided into control group, low-dose group, medium-dose group and high-dose group, 10 in each group. The low-dose group, medium-dose group and high-dose group were gavaged with 10.2, 20.4 and 30.6 g / kg Qingfei Huatan preparation suspension (equivalent to 12, 24 and 36 times the clinical dosage of adults), once a day for 30 consecutive days, and the control group was gavaged with an equal volume of distilled water. During the experiment, the rats ate and drank water normally. The general condition and food intake of the rats were observed on days 0, 7, 14, 21 and 28, and the body weight was recorded. After the experiment, all rats were fasted for 16 hours, and then killed by cervical dislocation under complete anesthesia (10% chloral hydrate). Blood was collected from the abdominal aorta for blood indices such as red blood cells, hemoglobin, white blood cells, neutrophils, lymphocytes and platelets, and serum biochemical indices such as ALB, TP, ALT, AST, TBIL, TG, TC, Cr, BUN and Glu. The rats were then dissected, and the main organs such as the heart, liver, kidney, stomach and duodenum were removed and weighed, and the organ coefficient was calculated. After fixation with 4% paraformaldehyde, the tissue was embedded in paraffin, sectioned and stained with hematoxylin-eosin (HE), and histopathological changes were observed under an optical microscope. Organ coefficient = organ mass / body mass × 100%

[0151] SPSS14.0 statistical software was used for analysis. Paired sample t test was used for comparison within two groups, independent sample t test was used for comparison between groups, and repeated measures analysis of variance was used for comparison between multiple groups. P < 0.05 was considered statistically significant.

[0152] 2.3 Statistical methods

[0153] 2.3.1 Acute toxicity test results

[0154] After a single intragastric administration of 127.6 g / kg of the Qingfei Huatan suspension, SPF-grade Kunming mice showed good mental state, smooth and neat fur, active movements, normal diet and drinking, no obvious symptoms of poisoning, and no animal death during continuous observation for 14 days. Compared with the control group, the size, shape, color and texture of the main organs such as the heart, liver, kidney, stomach and duodenum in the drug-treated group did not change abnormally.

[0155] 2.3.2 Subacute toxicity test results

[0156] 2.3.2.1 General conditions of the four groups of rats

[0157] During the experiment, the four groups of rats had normal fur color, good mental state, no significant changes in food intake and food utilization, normal defecation, and slightly sticky feces in the high-dose group. No obvious symptoms of poisoning were observed, and no deaths occurred.

[0158] 2.3.2.2 Comparison of body mass changes among the four groups

[0159] Compared with the control group, there was no statistically significant difference in body weight between male and female rats in the low, medium and high dose groups on days 0, 7, 14, 21 and 28 (P>0.05). See Table 3.

[0160] Table 3 Comparison of body weight changes of rats in four groups

[0161]

[0162] 2.3.2.3 Comparison of changes in blood parameters among four groups of rats

[0163] Compared with the control group, except for platelet count, the other blood indexes of female and male mice in the low, medium and high dose groups had no statistically significant differences (P>0.05). See Table 4.

[0164] Table 4 Comparison of changes in blood indexes of four groups of rats

[0165]

[0166]

[0167] Note: Compared with the control group, 1) P < 0.05.

[0168] 2.3.2.4 Morphological and histological changes of major organs in the four groups

[0169] Compared with the control group, in the subacute toxicity experiment, the appearance structure and tissue morphology of important organs such as the heart, liver, kidney, stomach and duodenum in the low, medium and high dose groups showed no obvious abnormalities, no bleeding, swelling, discoloration, nodules, ulcers or other visible pathological changes, and the cell structure of each organ tissue was intact, without inflammatory infiltration, cell necrosis, fibrosis or other abnormal pathological changes, and the difference was not statistically significant (P>0.05). Figure 1 .

[0170] 3. Clinical Trial Research

[0171] The Chinese medicine combination was observed for the clinical efficacy of 180 cases of phlegm-heat blocking lung cough, and a good clinical effect was obtained. Methods: 180 patients with phlegm-heat blocking lung cough were selected by random grouping and parallel control, and randomly divided into a treatment group of 90 cases and a control group of 90 cases. The patients in the control group were given basic Western medicine treatment, namely, compound methoxyphenamine capsules produced by Daiichi Sankyo Pharmaceutical (Shanghai) Co., Ltd., with specifications of 12.5 mg methoxyphenamine hydrochloride, 7 mg narcotine, 25 mg aminophylline, 2 mg chlorpheniramine maleate per tablet, product batch number SY063AA; patients took compound methoxyphenamine capsules orally, 2 capsules / time, 3 times / d, and patients in the treatment group were given basic Western medicine treatment combined with oral Chinese medicine combination, namely, patients in the treatment group took a large dose of Example 3 orally on the basis of the treatment of the control group, 1 bag (15g) / time, 3 times / d. The course of treatment for both groups was 10 days, and follow-up was continued for 10 days. The clinical efficacy of the two groups was evaluated, the cough disappearance rate, cough visual analogue score (VAS) and total score of clinical symptoms were compared between the two groups, and the improvement of common clinical symptoms was observed between the two groups.

[0172] Results: After treatment, the total clinical effective rate of the treatment group and the control group was 97.3% and 68.0%, respectively. The therapeutic effect of the treatment group was better than that of the control group (P<0.01). After treatment, the cough disappearance rate of the treatment group was 52.0%, and that of the control group was 17.3%. The cough disappearance rate of the treatment group was significantly higher than that of the control group (P<0.01). Compared with before treatment, the cough VAS score of the patients in the treatment group decreased on the first day of treatment (P<0.05), and the cough VAS score of the patients on the second, third and tenth days of treatment were significantly reduced (P<0.01), and the score of the patients in the treatment group was lower than that of the control group during the same period (P<0.05, P<0.01); the cough VAS score of the patients in the control group was lower than that before treatment on the tenth day of treatment (P<0.05). After treatment, the total symptom scores of the two groups of patients were significantly lower than those before treatment (P<0.05, P<0.01), and the total score of the patients in the treatment group was lower than that of the control group (P<0.01). After treatment, the clinical symptoms of both groups of patients were significantly improved (P < 0.05), and the symptom improvement of the treatment group was better than that of the control group (P < 0.05). See Table 5.

[0173] Table 5 Comparison of clinical efficacy between the two groups

[0174] Group n / example Clinical control / case Significant effect efficient invalid Total Effectiveness Treatment Group 90 20 54 34 2 97.3％ Control group 90 26 40 22 28 68％

[0175] Compared with the control group: *P<0.05.

[0176] Conclusion: The Chinese medicine combination preparation can effectively relieve the clinical symptoms of patients with phlegm-heat blocking lung type cough, reduce the severity of cough, and significantly improve the clinical efficacy.

[0177] The cured cases were followed up. During the three months of follow-up, none of the cured patients in the treatment group and the cured patients in the control group had relapses, indicating that the Chinese medicine preparation of the present invention has the advantages of reliable efficacy and no relapse.

[0178] IV. Research on the Quality of Traditional Chinese Medicine Preparations

[0179] In order to better control product quality, a product quality study was conducted and the results are as follows:

[0180] 1. Identification: (1) Take this product and observe it under a microscope. The starch granules are oval in shape with a diameter of The umbilicus is dot-shaped, herringbone-shaped or horseshoe-shaped, located at the smaller end, with fine and dense layers (Fritillaria thunbergii). The oil tube contains golden secretions (Peucedanum chinense). The calcium oxalate needle crystals are small, long Irregularly filled in the thin-walled cells (Atractylodes macrocephala). The fiber bundles are bright yellow, and the surrounding cells contain calcium oxalate crystals, forming crystal fibers. The walls of the crystal-containing cells are lignified and thickened (Phellodendron chinense). The bast fibers are light yellow, fusiform, thick-walled, and have fine pores (Scutellaria baicalensis). The fibers are colorless, with a diameter of Thick wall, no obvious pores (mulberry bark). Contains light yellow granules (Planthoceras grandiflora).

[0181] (2) Take 2g of this product, grind it into powder; or cut it into pieces, add 20ml of methanol, and treat it with ultrasound at a power of 250W and a frequency of 33kHz for 30 minutes. Cool it, filter it, evaporate the filtrate to dryness, and add 2ml of methanol to the residue to dissolve it, which is used as the test solution. Take another baicalin reference substance, add methanol to make a solution containing 1mg per 1ml, which is used as the reference solution. According to the thin layer chromatography method (General Rule 0502), 5ul of each of the above two solutions are respectively spotted on the same silica gel G thin layer plate with a sodium carboxymethyl cellulose solution containing 4% sodium acetate as the adhesive, and ethyl acetate-butanone-formic acid-water (5:3:1:1, volume ratio) as the developing agent. The thin layer plate is placed in a developing cylinder for pre-saturation for 30 minutes, developed, taken out, dried, and sprayed with 1% ferric chloride ethanol solution. In the chromatogram of the test product, the same dark green spots appear at the corresponding positions of the chromatogram of the reference substance. See Figure 2 .

[0182] (3) Take 6g of this product, grind it into powder, add 30ml of methanol, treat it with ultrasound at 250W and 33kHz for 20 minutes, let it cool, filter it, concentrate the filtrate to 10ml, add it to a neutral alumina column (100-200 mesh, 5g, inner diameter 1.5cm), elute it with 30ml of methanol, collect the eluate, evaporate it to dryness, add 5ml of methanol to dissolve the residue, and use it as the test solution. Take another reference substance of gardenia glycosides, add ethanol to make a solution containing 4mg per 1ml, and use it as the reference substance solution. According to the thin layer chromatography method (General Rule 0502), take 5ul of each of the above two solutions and spot them on the same silica gel G thin layer plate, use ethyl acetate-acetone-formic acid-water (5:5:1:1, volume ratio) as the developing solvent, develop it, take it out, dry it, spray it with sulfuric acid ethanol (5→10) solution, and heat it at 110℃ until the spots are clearly colored. In the chromatogram of the test sample, a spot of the same color appears at the corresponding position in the chromatogram of the reference sample. Figure 3 .

[0183] (4) Take 6g of this product, grind it into powder, add 2ml of concentrated ammonia test solution and 30ml of chloroform, let it stand overnight, filter, evaporate the filtrate to dryness, add 2ml of chloroform to the residue to dissolve it, and use it as the test solution. Take another reference substance of matrine, add methanol to make a solution containing 0.5mg per 1ml, and use it as the reference substance solution. According to the thin layer chromatography method (General Rule 0502), take 2ul of each of the above two solutions and spot them on the same silica gel G thin layer plate, use toluene-ethyl acetate-acetone-concentrated ammonia test solution (2:4:3:0.2, volume ratio) as the developing agent, develop, take out, dry, and spray with dilute potassium bismuth iodide test solution. In the chromatogram of the test sample, spots of the same color appear at the corresponding position of the chromatogram of the reference substance. See Figure 4 .

[0184] 2. Content determination: Determine according to high performance liquid chromatography (General Rule 0512).

[0185] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as filler; methanol-water-phosphoric acid (38:62:0.3) was used as mobile phase; the detection wavelength was 280nm. The theoretical plate number calculated based on the baicalin peak should be no less than 2000.

[0186] Preparation of reference solution: Take an appropriate amount of baicalin reference substance, weigh it accurately, and add 70% ethanol to make a solution containing 20ug per 1ml.

[0187] Preparation of test solution: Grind the product into powder, take about 0.5 g and weigh accurately; transfer to a 250 ml round-bottom flask, accurately add 100 ml of 70% ethanol, weigh the weight, heat under reflux at 45° for 3 hours, cool, weigh again, make up the lost weight with 70% ethanol, shake well, filter, and take the filtrate to obtain the solution.

[0188] The determination method is to accurately pipette 10ul of the reference solution and the test solution respectively, inject them into the liquid chromatograph, and determine the result.

[0189] This product contains baicalin (C 21 H 18 O 11 ) shall not be less than 3.5 mg per 1g. Figure 5 .

[0190] Although the embodiments of the present invention are disclosed for illustrative purposes, those skilled in the art will appreciate that various substitutions, changes and modifications are possible without departing from the spirit and scope of the present invention and the appended claims. Therefore, the scope of the present invention is not limited to the contents disclosed in the embodiments.

Claims

1. A Chinese medicine composition for preventing and treating phlegm-heat blocking lung type cough, characterized in that: The Chinese medicine composition contains effective amounts of two or more main drugs, auxiliary drugs, adjuvant drugs and guiding drugs that are mixed or stored separately, wherein: The monarch drugs include: Scutellaria baicalensis and Morus alba bark; The ministerial drugs include: Phellodendron amurense, Gardenia jasminoides, and Fritillaria thunbergii; The adjuvants include: Platycodon grandiflorum, Peucedanum chinense, Sophora flavescens, Rhizoma Anemarrhenae, Atractylodes macrocephala, Radix Trichosanthis, and Rhizoma Zingiberis; The adjuvant drug includes: roasted licorice root.

2. The Chinese medicine composition according to claim 1, characterized in that: In the traditional Chinese medicine composition, compared with 100 parts by weight of the roasted liquorice root, the content of the Radix Trichosanthis is 110-140 parts by weight, the content of the dried ginger is 30-60 parts by weight, the content of the Atractylodes macrocephala is 140-170 parts by weight, the content of the Peucedanum peucedanum is 45-75 parts by weight, the content of the Platycodon grandiflorum is 110-140 parts by weight, the content of the Sophora flavescens is 80-110 parts by weight, the content of the Phellodendron chinense is 45-75 parts by weight, the content of the Fritillaria thunbergii is 120-160 parts by weight, the content of the Rhizoma Anemarrhenae is 80-110 parts by weight, the content of the Gardenia jasminoides is 110-140 parts by weight, the content of the Morus alba bark is 140-170 parts by weight, and the content of the Scutellaria baicalensis is 140-170 parts by weight.

3. The Chinese medicine composition according to claim 1, characterized in that: Relative to 100 parts by weight of the roasted licorice root, the content of the Radix Trichosanthis is 115-135 parts by weight, the content of the dried ginger is 35-55 parts by weight, the content of the Atractylodes macrocephala is 145-165 parts by weight, the content of the Peucedanum peucedanum is 55-70 parts by weight, the content of the Platycodon grandiflorum is 115-130 parts by weight, the content of the Sophora flavescens is 85-100 parts by weight, the content of the Phellodendron chinense is 55-70 parts by weight, the content of the Fritillaria thunbergii is 125-150 parts by weight, the content of the Anemarrhena asphodeloides is 85-100 parts by weight, the content of the Gardenia jasminoides is 115-130 parts by weight, the content of the Morus alba bark is 145-165 parts by weight, and the content of the Scutellaria baicalensis is 145-160 parts by weight.

4. The Chinese medicine composition according to claim 1, characterized in that: Relative to 100 parts by weight of the roasted licorice root, the content of the Radix Trichosanthis is 116±1 parts by weight, the content of the dried ginger is 35±1 parts by weight, the content of the Atractylodes macrocephala is 145±1 parts by weight, the content of the Peucedanum peucedanum is 65±1 parts by weight, the content of the Platycodon grandiflorum is 116±1 parts by weight, the content of the Sophora flavescens is 85±1 parts by weight, the content of the Phellodendron chinense is 65±1 parts by weight, the content of the Fritillaria thunbergii is 126±1 parts by weight, the content of the Anemarrhena asphodeloides is 85±1 parts by weight, the content of the Gardenia jasminoides is 115±1 parts by weight, the content of the Morus alba bark is 145±1 parts by weight, and the content of the Scutellaria baicalensis is 145±1 parts by weight.

5. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: It is prepared by mixing various components evenly.

6. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for preventing and treating cough due to phlegm-heat blocking the lungs.

7. A medicament for preventing and treating phlegm-heat blocking lung type cough using the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The medicament contains active components and auxiliary materials, and the active components contain the traditional Chinese medicine composition.

8. The medicament according to claim 7, characterized in that: Based on the total weight of the medicament, the content of the active component is 20-80% by weight.

9. The medicament according to claim 7, characterized in that: The auxiliary material is selected from at least one of starch, dextrin, powdered sugar, calcium carbonate, calcium phosphate and microcrystalline cellulose; Alternatively, the pharmaceutical dosage form is capsule, pill, paste, pill or tablet.

10. A capsule for preventing and treating cough due to phlegm-heat blocking the lungs, using the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The capsule contains 50-80% by weight of the traditional Chinese medicine composition as an active component, and the excipients in the capsule are at least one of starch, dextrin, powdered sugar, calcium carbonate, calcium phosphate, microcrystalline cellulose, mannitol, vegetable oil, gelatin, polyethylene glycol, stevioside, and magnesium stearate; the average particle size of the active component is 120-355 μm.

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