Application of pharmaceutical composition in prevention and treatment of lung diseases

Abstract

The invention discloses application of a pharmaceutical composition in prevention and treatment of lung diseases, and the traditional Chinese medicine composition comprises the following raw material medicines in parts by weight: 50-250 parts of peach kernel, 300-700 parts of salvia miltiorrhiza, 200-600 parts of gynostemma pentaphylla, 150-450 parts of fermented cordyceps sinensis powder, 50-250 parts of pine pollen, 50-250 parts of schisandra chinensis and a proper amount of starch. The pharmaceutical composition provided by the invention can eliminate phlegm and relieve cough, and can be used for preventing and / or treating chronic bronchitis, relating to the delay period and the remission period of chronic bronchitis.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to use of a pharmaceutical composition in preventing and treating lung diseases. Background Art

[0002] Chronic bronchitis is characterized by repeated coughing, sputum, and wheezing. It is a common chronic inflammatory disease of the respiratory system and is more common in the elderly. Data show that the incidence of chronic bronchitis in the elderly in my country exceeds 14%, and it is difficult to cure. If it is not treated in time, it will damage the respiratory and circulatory systems and even affect life safety. According to the condition, the disease is clinically divided into acute attack period, chronic protracted period, and clinical remission period. Traditional Chinese medicine classifies chronic bronchitis into the categories of "cough" and "wheezing syndrome". The acute attack period is mostly dominated by evil, and the main treatment principle is to remove evil and benefit the lungs. The chronic protracted period is mostly due to deficiency of the body and evil lingering. The treatment should take into account both the symptoms and the root. The remission period is mostly due to deficiency of the body, and attention should be paid to strengthening the body and strengthening the lungs, spleen, and kidneys. The lungs are responsible for breathing and are the root of qi, while the kidneys are responsible for receiving qi and are the root of qi. Kidney yin is the root of the body's yin fluid, and lung yin depends on the continuous nourishment of kidney yin; gold can produce water, and kidney yin also depends on the nourishment of lung yin. If the patient is old and has insufficient kidney yin, or has been ill for a long time and has lung yin deficiency, then metal and water cannot be generated, and over time, both the lung and kidney become deficient, resulting in the lung being unable to control qi and the kidney being unable to receive qi, which manifests as cough and asthma. The treatment is mainly to nourish the lung and kidney, and stop cough and asthma.

[0003] There is no related report in the prior art on the use of the pharmaceutical composition claimed in the present invention in preventing and treating lung diseases. Summary of the invention

[0004] Based on this, the present invention provides a use of a pharmaceutical composition in preventing and treating lung diseases. The raw materials of the pharmaceutical composition include, by weight, 50-250 parts of peach kernels, 300-700 parts of salvia miltiorrhiza, 200-600 parts of gynostemma pentaphyllum, 150-450 parts of fermented cordyceps powder, 50-250 parts of pine pollen, 50-250 parts of schisandra chinensis, and an appropriate amount of starch.

[0005] Furthermore, the raw materials of the pharmaceutical composition include, by weight: 100-200 parts of peach kernels, 500-600 parts of salvia miltiorrhiza, 300-500 parts of gynostemma pentaphyllum, 200-300 parts of fermented cordyceps powder, 100-200 parts of pine pollen, 100-200 parts of schisandra chinensis, and an appropriate amount of starch.

[0006] Furthermore, in parts by weight, the raw materials of the pharmaceutical composition include: about 130 parts of peach kernel, about 530 parts of salvia miltiorrhiza, about 400 parts of gynostemma pentaphyllum, about 260 parts of fermented cordyceps powder, about 130 parts of pine pollen, about 130 parts of schisandra chinensis, and an appropriate amount of starch.

[0007] According to another aspect of the present invention, a pharmaceutical composition is provided for use in preventing and treating lung diseases. The pharmaceutical composition is prepared by adding the following Chinese herbal extracts in the following weight percentage ratios as active ingredients, and adding auxiliary materials: 25-55% of salvia miltiorrhiza extract, 12-40% of gynostemma pentaphyllum extract, 5-12% of schisandra chinensis alcohol extract, 12-30% of cordyceps mycelium extract, 6-12% of pine pollen extract, 5-30% of peach kernel extract, and the rest as auxiliary materials;

[0008] The above-mentioned pharmaceutical compound preparation wherein each effective component is prepared by the following method:

[0009] ① Salvia miltiorrhiza extract

[0010] Take Danshen medicinal material, crush it into granules, add about 12 times of water, extract twice at 95℃±2, combine the extracts and concentrate for later use. After testing, it is found that the water-soluble components of Danshen are mainly salvianolic acid B and sodium danshensu. Add about 70% ethanol to the residues and reflux twice, each time for about 1 hour, combine the extracts and concentrate for later use. After testing, the fat-soluble components of Danshen are mainly tanshinone. Combine the concentrated solutions and dry them for later use.

[0011] ② Gynostemma pentaphyllum extract

[0012] After the Gynostemma pentaphyllum medicinal material is soaked in about 75% ethanol, high-frequency ultrasonic extraction is performed three times to obtain the Gynostemma pentaphyllum extract, and the main component is total saponin after testing;

[0013] ③Schisandra chinensis ethanol extract

[0014] The raw material of Schisandra chinensis is added with about 80% ethanol for reflux extraction twice, and the extract is dried after the ethanol is recovered, and then crushed to obtain fine powder. After testing, the lignan components in Schisandra chinensis belong to the biphenylcyclooctene type lignan components, and Schisandrin A is the main component; the extraction rate of Schisandrin A by reflux extraction with about 80% ethanol is 0.3% to 2.0%;

[0015] ④Cordyceps mycelium extract

[0016] Take the Cordyceps mycelium raw material, add about 75% ethanol and warm extract three times, combine the extracts, recover the ethanol, and dry the extracts for later use;

[0017] ⑤Pine pollen lipid extract

[0018] Using about 70% ethanol to reflux heat to extract pine pollen, recovering ethanol from the extract, and drying the extract for later use;

[0019] ⑥Peach kernel extract

[0020] The effective components of the traditional Chinese medicine peach kernel are water-soluble components. The peach kernel is decocted twice with about 10 times the amount of water by water decoction method, and the extract is concentrated into an extract, and the extract is dried for later use.

[0021] The above-mentioned extracts are dried by vacuum drying or spray drying.

[0022] Furthermore, the weight percentages of the active ingredients of the drug are: about 38% of salvia miltiorrhiza extract, about 25% of gynostemma pentaphyllum extract, about 6% of schisandra chinensis ethanol extract, about 19% of cordyceps mycelium extract, about 6% of pine pollen extract and about 6% of peach kernel extract.

[0023] Furthermore, the salvia miltiorrhiza extract contains 2.5-10% of salvianolic acid B; the schisandra chinensis extract contains 0.3-2.0% of schisandra alcohol A; the cordyceps mycelium extract contains 0.1-5.0% of adenosine; and the gynostemma pentaphyllum extract contains 0.5-8.0% of total saponins.

[0024] Furthermore, the pharmaceutical composition further comprises one or more drugs and / or extracts for preventing and treating lung diseases.

[0025] Furthermore, the drug is selected from one or more of the following: antibiotics, bronchodilators, glucocorticoids, antitussive and expectorant drugs, and antiasthmatic drugs.

[0026] Furthermore, the antibiotic is selected from one or more of the following: quinolone antibiotics, macrolide antibiotics and β-lactam antibiotics.

[0027] Furthermore, the bronchodilator is salbutamol sulfate and / or terbutaline sulfate.

[0028] Furthermore, the glucocorticoid is prednisolone acetate.

[0029] Furthermore, the antitussive and expectorant is compound licorice mixture, bromhexine, ambroxol hydrochloride, myrtle oil and / or dextromethorphan.

[0030] Furthermore, the antiasthmatic drug is aminophylline.

[0031] Furthermore, the pharmaceutical composition further comprises one or more pharmaceutically acceptable excipients.

[0032] Furthermore, the auxiliary material is selected from one or more of the following: diluent, wetting agent, binder, disintegrant, inclusion agent, flavoring agent, sustained-release agent, retention agent, lubricant, dispersant, plasticizer, opacifier and antioxidant.

[0033] Furthermore, the dosage form of the pharmaceutical composition is powder, tablet, pill, capsule, film, lozenge, granule, injection or oral solution.

[0034] Furthermore, the dosage form of the pharmaceutical composition is capsule or tablet.

[0035] Furthermore, the tablet is a dispersible tablet or a sustained-release tablet.

[0036] Furthermore, the preparation method of the pharmaceutical composition comprises the following steps:

[0037] (1) adding water to decoct the salvia miltiorrhiza, peach kernel and gynostemma pentaphyllum weighed in weight ratio, combining the decoctions, taking the supernatant, concentrating it into an extract, cooling it, adding ethanol, precipitating it and filtering it;

[0038] (2) weighing another portion of the fermented Cordyceps sinensis powder, adding ethanol to Schisandra chinensis and refluxing, cooling, combining the ethanol solution, filtering, and concentrating the filtrate to dryness;

[0039] (3) weighing pine pollen and adding ethanol to warm immerse, combining the leaching solution, concentrating and drying to form a dry paste; and

[0040] (4) Take the three dry pastes mentioned above, mix and grind them, add an appropriate amount of starch, mix well, and obtain the pharmaceutical composition.

[0041] Further, the lung disease includes bronchitis, tuberculosis, pulmonary embolism, asthma, pneumonia and / or lung cancer.

[0042] Furthermore, the bronchitis is acute bronchitis or chronic bronchitis.

[0043] Furthermore, the lung disease is a lung disease with clinical symptoms of cough and / or sputum.

[0044] Furthermore, the lung disease is a lung disease caused by smoking, haze or other smoke factors.

[0045] According to another aspect of the present invention, there is provided a use of a pharmaceutical composition in the preparation of a drug for maintaining the integrity and morphology of bronchial walls and / or reducing inflammatory cell infiltration, wherein the raw materials of the pharmaceutical composition include, by weight: 50-250 parts of peach kernels, 300-700 parts of salvia miltiorrhiza, 200-600 parts of gynostemma pentaphyllum, 150-450 parts of fermented cordyceps powder, 50-250 parts of pine pollen, 50-250 parts of schisandra chinensis, and an appropriate amount of starch;

[0046] Alternatively, the pharmaceutical composition is prepared by adding the following Chinese herbal extracts in the following weight percentage ratios as the active ingredients, and adding excipients: 25-55% of Salvia miltiorrhiza extract, 12-40% of Gynostemma pentaphyllum extract, 5-12% of Schisandra chinensis alcohol extract, 12-30% of Cordyceps mycelium extract, 6-12% of pine pollen extract, 5-30% of peach kernel extract, and the rest as excipients;

[0047] The above-mentioned pharmaceutical compound preparation wherein each effective component is prepared by the following method:

[0048] ① Salvia miltiorrhiza extract

[0049] Take Danshen medicinal material, crush it into granules, add about 12 times of water, extract twice at 95℃±2, combine the extracts and concentrate for later use. After testing, it is found that the water-soluble components of Danshen are mainly salvianolic acid B and sodium danshensu. Add about 70% ethanol to the residues and reflux twice, each time for about 1 hour, combine the extracts and concentrate for later use. After testing, the fat-soluble components of Danshen are mainly tanshinone. Combine the concentrated solutions and dry them for later use.

[0050] ② Gynostemma pentaphyllum extract

[0051] After the Gynostemma pentaphyllum medicinal material is soaked in about 75% ethanol, high-frequency ultrasonic extraction is performed three times to obtain the Gynostemma pentaphyllum extract, and the main component is total saponin after testing;

[0052] ③Schisandra chinensis ethanol extract

[0053] The raw material of Schisandra chinensis is added with about 80% ethanol for reflux extraction twice, and the extract is dried after the ethanol is recovered, and then crushed to obtain fine powder. After testing, the lignan components in Schisandra chinensis belong to the biphenylcyclooctene type lignan components, and Schisandrin A is the main component; the extraction rate of Schisandrin A by reflux extraction with about 80% ethanol is 0.3% to 2.0%;

[0054] ④Cordyceps mycelium extract

[0055] Take the Cordyceps mycelium raw material, add about 75% ethanol and warm extract three times, combine the extracts, recover the ethanol, and dry the extracts for later use;

[0056] ⑤Pine pollen lipid extract

[0057] Using about 70% ethanol to reflux heat to extract pine pollen, recovering ethanol from the extract, and drying the extract for later use;

[0058] ⑥Peach kernel extract

[0059] The effective components of the traditional Chinese medicine peach kernel are water-soluble components. The peach kernel is decocted twice with about 10 times the amount of water by water decoction method, and the extract is concentrated into an extract, and the extract is dried for later use.

[0060] The above-mentioned extracts are dried by vacuum drying or spray drying.

[0061] Beneficial effects of the present invention:

[0062] The pharmaceutical composition of the present invention can eliminate phlegm and relieve cough, and can be used to prevent and / or treat chronic bronchitis, and relates to the extended period and remission period of chronic bronchitis. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without exceeding the scope of protection required by the present invention.

[0064] Figure 1 The figure is a schematic diagram of the effect of the pharmaceutical composition of the present invention on expectoration in mice (n=10, mean±SD). *P<0.05 vs. model group, **P<0.01 vs. model group, one way ANOVA.

[0065] Figure 2 The figure is a schematic diagram of the effect of the pharmaceutical composition of the present invention on the cough latency of mice (n=10, mean±SD). *P<0.05 vs. model group, **P<0.01 vs. model group, one way ANOVA.

[0066] Figure 3 The figure is a schematic diagram of the effect of the pharmaceutical composition of the present invention on the total number of coughs in mice within 2 minutes (n=10, mean±SD). **P<0.01 vs. model group, one way ANOVA.

[0067] Figure 4 The figure is a schematic diagram of the effect of the pharmaceutical composition of the present invention on the body weight of mice with chronic bronchitis (n=10, mean±SD). *P<0.05 vs. model group, **P<0.01 vs. blank group.

[0068] Figure 5 This is a schematic diagram of the pathological results of the effect of the pharmaceutical composition of the present invention on the lungs of mice with chronic bronchitis. DETAILED DESCRIPTION

[0069] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present invention.

[0070] Unless otherwise indicated, all technical and scientific terms and abbreviations used herein have the meanings commonly understood by those of ordinary skill in the field of the invention or the field in which the terms are used. Although any methods, conditions, substances or materials similar to or equivalent to those disclosed herein may be used in the practice of the present invention, preferred methods, conditions, substances or materials are described herein.

[0071] The present invention is intended to encompass all alternatives, variations and equivalents that may be included in the present invention as defined by the claims. Those skilled in the art will recognize many methods and materials similar or equivalent to those described herein that can be used in the practice of the present invention. The present invention is in no way limited to the methods and materials described.

[0072] As used in the specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0073] In the present invention, the term "comprising" is synonymous with "including". As used herein, the terms "comprising", "including", "having", "containing" or any other variation thereof are intended to cover a non-exclusive inclusion. For example, a composition, process, method, article, or apparatus comprising the listed elements is not necessarily limited to only those elements, but may include other elements not expressly listed or inherent to such composition, process, method, article, or apparatus.

[0074] As described in the background technology section, there is no related report on the use of the pharmaceutical composition claimed in the present invention in preventing and treating lung diseases in the prior art. In order to solve the above problems, the present invention provides a pharmaceutical composition for preventing and treating lung diseases. The raw materials of the pharmaceutical composition include, by weight: 50-250 parts of peach kernel, 300-700 parts of salvia miltiorrhiza, 200-600 parts of gynostemma pentaphyllum, 150-450 parts of fermented cordyceps powder, 50-250 parts of pine pollen, 50-250 parts of schisandra chinensis, and an appropriate amount of starch.

[0075] In the present invention, when weight part, weight percentage, time, pressure, ratio, equivalent, concentration or other value or parameter are represented with scope, preferred range or a series of upper preferred value and lower preferred value, this should be understood as specifically disclosing all scopes formed by any pairing of any range upper limit or preferred value and any range lower limit or preferred value, regardless of whether the scope is disclosed separately. For example, when disclosing scope "50-250", described scope should be interpreted as including scope "50-200", "50-150", "50-250", "50-100" etc. When numerical range is described in this article, unless otherwise stated, the scope is intended to include its end value and all integers and fractions within the scope.

[0076] In the present invention, the term "prevention" includes "treatment" and "prevention", unless there is a specific description to the contrary. The terms "treatment" and "therapeutically" should be understood accordingly.

[0077] In the present invention, the term "treatment" includes alleviating, inhibiting or improving the symptoms or conditions of a disease; inhibiting the occurrence of complications; improving or preventing potential metabolic syndrome; inhibiting the occurrence of a disease or symptom, such as controlling the development of a disease or condition; alleviating a disease or symptom; reducing a disease or symptom; alleviating complications caused by a disease or symptom, or preventing or treating signs caused by a disease or symptom. As used herein, a pharmaceutical composition or a pharmaceutical preparation, after administration, can improve a disease, symptom or condition, especially improve its severity, delay the onset, slow the progression of the disease, or reduce the duration of the disease. Whether fixed or temporary administration, continuous or intermittent administration, can be attributed to or related to the administration.

[0078] In a preferred embodiment, the raw materials of the pharmaceutical composition include, by weight: 100-200 parts of peach kernel, 500-600 parts of salvia miltiorrhiza, 300-500 parts of gynostemma pentaphyllum, 200-300 parts of fermented cordyceps powder, 100-200 parts of pine pollen, 100-200 parts of schisandra chinensis, and an appropriate amount of starch.

[0079] In a preferred embodiment, the raw materials of the pharmaceutical composition include, by weight: about 130 parts of peach kernel, about 530 parts of salvia miltiorrhiza, about 400 parts of gynostemma pentaphyllum, about 260 parts of fermented cordyceps powder, about 130 parts of pine pollen, about 130 parts of schisandra chinensis, and an appropriate amount of starch.

[0080] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 130" includes ±5% of 130, or from 123.5 to 136.5; "about 530" includes ±5% of 530, or from 503.5 to 556.5; "about 400" includes ±5% of 400, or from 380 to 420; "about 260" includes ±5% of 260, or from 247 to 273.

[0081] According to another aspect of the present invention, a pharmaceutical composition is provided for use in preventing and treating lung diseases. The pharmaceutical composition is prepared by adding the following Chinese herbal extracts in the following weight percentage ratios as active ingredients, and adding auxiliary materials: 25-55% of salvia miltiorrhiza extract, 12-40% of gynostemma pentaphyllum extract, 5-12% of schisandra chinensis alcohol extract, 12-30% of cordyceps mycelium extract, 6-12% of pine pollen extract, 5-30% of peach kernel extract, and the rest as auxiliary materials;

[0082] The above-mentioned pharmaceutical compound preparation wherein each effective component is prepared by the following method:

[0083] ① Salvia miltiorrhiza extract

[0084] Take Danshen medicinal material, crush it into granules, add about 12 times of water, extract twice at 95℃±2, combine the extracts and concentrate for later use. After testing, it is found that the water-soluble components of Danshen are mainly salvianolic acid B and sodium danshensu. Add about 70% ethanol to the residues and reflux twice, each time for about 1 hour, combine the extracts and concentrate for later use. After testing, the fat-soluble components of Danshen are mainly tanshinone. Combine the concentrated solutions and dry them for later use.

[0085] ② Gynostemma pentaphyllum extract

[0086] After the Gynostemma pentaphyllum medicinal material is soaked in about 75% ethanol, high-frequency ultrasonic extraction is performed three times to obtain the Gynostemma pentaphyllum extract, and the main component is total saponin after testing;

[0087] ③Schisandra chinensis ethanol extract

[0088] The raw material of Schisandra chinensis is added with about 80% ethanol for reflux extraction twice, and the extract is dried after the ethanol is recovered, and then crushed to obtain fine powder. After testing, the lignan components in Schisandra chinensis belong to the biphenylcyclooctene type lignan components, and Schisandrin A is the main component; the extraction rate of Schisandrin A by reflux extraction with about 80% ethanol is 0.3% to 2.0%;

[0089] ④Cordyceps mycelium extract

[0090] Take the Cordyceps mycelium raw material, add about 75% ethanol and warm extract three times, combine the extracts, recover the ethanol, and dry the extracts for later use;

[0091] ⑤Pine pollen lipid extract

[0092] Using about 70% ethanol to reflux heat to extract pine pollen, recovering ethanol from the extract, and drying the extract for later use;

[0093] ⑥Peach kernel extract

[0094] The effective components of the traditional Chinese medicine peach kernel are water-soluble components. The peach kernel is decocted twice with about 10 times the amount of water by water decoction method, and the extract is concentrated into an extract, and the extract is dried for later use.

[0095] The above-mentioned extracts are dried by vacuum drying or spray drying.

[0096] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 12" includes ±5% of 12, or from 11.4 to 12.6; "about 70" includes ±5% of 70, or from 66.5 to 73.5; "about 1" includes ±5% of 1, or from 0.95 to 1.05; "about 75" includes ±5% of 75, or from 71.25 to 78.75; "about 80" includes ±5% of 80, or from 76 to 84; "about 10" includes ±5% of 10, or from 9.5 to 10.5.

[0097] In a preferred embodiment, the weight percentages of the active ingredients of the drug are: about 38% of Salvia miltiorrhiza extract, about 25% of Gynostemma pentaphyllum extract, about 6% of Schisandra chinensis ethanol extract, about 19% of Cordyceps mycelium extract, about 6% of pine pollen extract and about 6% of peach kernel extract.

[0098] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 38" includes ±5% of 38, or from 36.1 to 39.9; "about 25" includes ±5% of 25, or from 23.75 to 26.25; "about 6" includes ±5% of 6, or from 5.7 to 6.3; "about 19" includes ±5% of 19, or from 18.05 to 19.95.

[0099] In a preferred embodiment, the salvia miltiorrhiza extract contains 2.5-10% salvianolic acid B; the schisandra chinensis extract contains 0.3-2.0% schisandra alcohol A; the cordyceps mycelium extract contains 0.1-5.0% adenosine; and the gynostemma pentaphyllum extract contains 0.5-8.0% total saponins.

[0100] In a preferred embodiment, the pharmaceutical composition further comprises one or more drugs and / or extracts for preventing and treating lung diseases.

[0101] In a preferred embodiment, the drug is selected from one or more of the following: antibiotics, bronchodilators, glucocorticoids, antitussive and expectorant drugs, and antiasthmatic drugs.

[0102] In a preferred embodiment, the antibiotic is selected from one or more of the following: quinolone antibiotics, macrolide antibiotics and β-lactam antibiotics.

[0103] In a preferred embodiment, the bronchodilator is salbutamol sulfate and / or terbutaline sulfate.

[0104] In a preferred embodiment, the glucocorticoid is prednisolone acetate.

[0105] In a preferred embodiment, the antitussive and expectorant is compound liquorice mixture, bromhexine, ambroxol hydrochloride, myrtle oil and / or dextromethorphan.

[0106] In a preferred embodiment, the antiasthmatic drug is aminophylline.

[0107] In a preferred embodiment, the pharmaceutical composition further comprises one or more pharmaceutically acceptable excipients.

[0108] In a preferred embodiment, the pharmaceutical preparation of the present invention contains at least one pharmaceutically acceptable excipient in an amount of 0.00001 to 50 wt.%, or 0.0001 to 10 wt.%, or 0.0001 to 5 wt.%, or 0.005 to 1 wt.%, or 0.1 to 20 wt.%, or 0.5 to 15 wt.%, or 1 to 5 wt.%, based on the weight of the pharmaceutical preparation.

[0109] In the present invention, the term "pharmaceutically acceptable" refers to a substance, such as a carrier or diluent, that does not abrogate the biological activity or properties of the compound and is relatively non-toxic, i.e., a substance that does not cause undesirable biological effects or interact in a deleterious manner with any of its components when administered to an individual.

[0110] In the present invention, the term "pharmaceutically acceptable excipient" refers to carriers and / or excipients that are pharmacologically and / or physiologically compatible with subjects and active ingredients (i.e., capable of inducing the desired therapeutic effect without causing any undesirable local or systemic effects), which are well known in the art (see, for example, Remington's Pharmaceutical Sciences. Edited by Gennaro AR, 19th ed. Pennsylvania: Mack Publishing Company, 1995).

[0111] In a preferred embodiment, the auxiliary material is selected from one or more of the following: diluent, wetting agent, binder, disintegrant, inclusion agent, flavoring agent, sustained-release agent, retention agent, lubricant, dispersant, plasticizer, opacifier and antioxidant.

[0112] Those skilled in the art will know how to select specific chemical substances within the scope of the above-mentioned auxiliary material category.For example, the diluent can be selected from one or more of the following: icing sugar, starch, compressible starch, lactose, dextrin, mannitol, sorbitol, microcrystalline cellulose, calcium sulfate and calcium carbonate.The wetting agent can be selected from one or more of the following: polyoxymethylene stearate, poloxamer, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene hydrogenated castor oil, polyoxyethylene alkyl ether, polysorbate such as polysorbate 80, cetyl alcohol, glycerol fatty acid ester (such as triacetin, glyceryl monostearate and the like), polyoxyethylene fatty acid ester, polyethylene glycol fatty acid ester, sodium lauryl sulfate, sorbitol fatty acid ester, sucrose fatty acid ester, polyoxyethylene ether, benzalkonium chloride, polyoxyethylene castor oil and docusate sodium.The adhesive can be selected from one or more of the following: polyvinyl pyrrolidone, hydroxypropyl cellulose, polyethylene glycol and methylcellulose. The disintegrant may be selected from one or more of the following: carboxymethylcellulose, carboxymethylcellulose calcium salt and sodium carboxymethylcellulose. The flavoring agent may be selected from one or more of the following: sorbitol, glucose, mannose, sucrose and lactose. The dispersant may be selected from one or more of the following: cross-linked sodium carboxymethylcellulose, sodium starch glycolate and pre-gelatinized corn starch. The plasticizer may be dibutyl sebacate and / or various citrates. The sustained-release agent may be selected from one or more of the following: sodium carboxymethylcellulose, low-substituted hydroxypropylcellulose, hydroxypropyl methylcellulose, microcrystalline cellulose, hydroxyethylcellulose, gum arabic, gelatin and shellac. The antioxidant may be selected from one or more of the following: sodium bisulfite, sodium pyrosulfite, sodium sulfite and sodium thiosulfate. The lubricant may be selected from one or more of the following: calcium stearate, talc, magnesium stearate, stearic acid and colloidal silicon dioxide.

[0113] These excipients are preferably pharmaceutically inert, or may have a synergistic or additive effect to enhance the therapeutic activity of the pharmaceutical composition, and the above-mentioned excipients are only listed. The excipients actually used in the present invention are not limited to the above-mentioned excipients and can be adjusted according to actual conditions to achieve the effects of the present invention.

[0114] In a preferred embodiment, the pharmaceutical composition is in the form of powder, tablet, pill, capsule, film, lozenge, granule, injection or oral solution.

[0115] In a preferred embodiment, the pharmaceutical composition is in the form of capsules or tablets.

[0116] In a preferred embodiment, the tablet is a dispersible tablet or a sustained-release tablet.

[0117] In a preferred embodiment, the preparation method of the pharmaceutical composition comprises the following steps:

[0118] (1) adding water to decoct the salvia miltiorrhiza, peach kernel and gynostemma pentaphyllum weighed in weight ratio, combining the decoctions, taking the supernatant, concentrating it into an extract, cooling it, adding ethanol, precipitating it and filtering it;

[0119] (2) weighing another portion of the fermented Cordyceps sinensis powder, adding ethanol to Schisandra chinensis and refluxing, cooling, combining the ethanol solution, filtering, and concentrating the filtrate to dryness;

[0120] (3) weighing pine pollen and adding ethanol to warm immerse, combining the leaching solution, concentrating and drying to form a dry paste; and

[0121] (4) Take the three dry pastes mentioned above, mix and grind them, add an appropriate amount of starch, mix well, and obtain the pharmaceutical composition.

[0122] In a preferred embodiment, the pulmonary disease includes bronchitis, tuberculosis, pulmonary embolism, asthma, pneumonia and / or lung cancer.

[0123] In a preferred embodiment, the bronchitis is acute bronchitis or chronic bronchitis.

[0124] In a preferred embodiment, the lung disease is a lung disease with clinical symptoms of cough and / or sputum.

[0125] In a preferred embodiment, the lung disease is a lung disease caused by smoking, haze or other smoke factors.

[0126] According to another aspect of the present invention, there is provided a use of a pharmaceutical composition in the preparation of a drug for maintaining the integrity and morphology of bronchial walls and / or reducing inflammatory cell infiltration, wherein the raw materials of the pharmaceutical composition include, by weight: 50-250 parts of peach kernels, 300-700 parts of salvia miltiorrhiza, 200-600 parts of gynostemma pentaphyllum, 150-450 parts of fermented cordyceps powder, 50-250 parts of pine pollen, 50-250 parts of schisandra chinensis, and an appropriate amount of starch;

[0127] Alternatively, the pharmaceutical composition is prepared by adding the following Chinese herbal extracts in the following weight percentage ratios as the active ingredients, and adding excipients: 25-55% of Salvia miltiorrhiza extract, 12-40% of Gynostemma pentaphyllum extract, 5-12% of Schisandra chinensis alcohol extract, 12-30% of Cordyceps mycelium extract, 6-12% of pine pollen extract, 5-30% of peach kernel extract, and the rest as excipients;

[0128] The above-mentioned pharmaceutical compound preparation wherein each effective component is prepared by the following method:

[0129] ② Salvia miltiorrhiza extract

[0130] Take Danshen medicinal material, crush it into granules, add about 12 times of water, extract twice at 95℃±2, combine the extracts and concentrate for later use. After testing, it is found that the water-soluble components of Danshen are mainly salvianolic acid B and sodium danshensu. Add about 70% ethanol to the residues and reflux twice, each time for about 1 hour, combine the extracts and concentrate for later use. After testing, the fat-soluble components of Danshen are mainly tanshinone. Combine the concentrated solutions and dry them for later use.

[0131] ② Gynostemma pentaphyllum extract

[0132] After the Gynostemma pentaphyllum medicinal material is soaked in about 75% ethanol, high-frequency ultrasonic extraction is performed three times to obtain the Gynostemma pentaphyllum extract, and the main component is total saponin after testing;

[0133] ③Schisandra chinensis ethanol extract

[0134] The raw material of Schisandra chinensis is added with about 80% ethanol for reflux extraction twice, and the extract is dried after the ethanol is recovered, and then crushed to obtain fine powder. After testing, the lignan components in Schisandra chinensis belong to the biphenylcyclooctene type lignan components, and Schisandrin A is the main component; the extraction rate of Schisandrin A by reflux extraction with about 80% ethanol is 0.3% to 2.0%;

[0135] ④Cordyceps mycelium extract

[0136] Take the Cordyceps mycelium raw material, add about 75% ethanol and warm extract three times, combine the extracts, recover the ethanol, and dry the extracts for later use;

[0137] ⑤Pine pollen lipid extract

[0138] Using about 70% ethanol to reflux heat to extract pine pollen, recovering ethanol from the extract, and drying the extract for later use;

[0139] ⑥Peach kernel extract

[0140] The effective components of the traditional Chinese medicine peach kernel are water-soluble components. The peach kernel is decocted twice with about 10 times the amount of water by water decoction method, and the extract is concentrated into an extract, and the extract is dried for later use.

[0141] The above-mentioned extracts are dried by vacuum drying or spray drying.

[0142] According to another aspect of the present invention, there is provided a pharmaceutical composition as described above for use in preventing and / or treating a lung disease such as chronic bronchitis in a subject.

[0143] According to another aspect of the present invention, there is provided a method for preventing and / or treating a lung disease such as chronic bronchitis in a subject, comprising administering an effective amount of the above-mentioned pharmaceutical composition to the subject.

[0144] According to another aspect of the present invention, there is provided a pharmaceutical composition as described above for maintaining the integrity and morphology of bronchial walls and / or reducing inflammatory cell infiltration.

[0145] According to another aspect of the present invention, there is provided a method for maintaining the integrity and morphology of the bronchial wall of a subject and / or reducing inflammatory cell infiltration, comprising administering an effective amount of the above-mentioned pharmaceutical composition to the subject.

[0146] In the present invention, the term "subject" is a mammal. The mammal may be a human, a non-human primate, a mouse, a rat, a dog, a cat, a horse or a cow, but is not limited to these examples. Mammals other than humans can be advantageously used as subjects representing lung disease models. Preferably, the subject is a human.

[0147] The "effective amount" of the pharmaceutical composition or preparation used in the present invention can obtain the desired treatment and / or prevention effect. The amount effective for this purpose will depend on, for example, the pharmaceutical composition, the mode of administration, the stage and severity of the disease to be treated, the individual's body weight and overall health, and the judgment of the prescribing physician. The dosage can be given once a week, or once every two days or every day, or even several times a day. The dosage unit can be given in a short period of time (e.g., weeks to months) or longer time periods (months to years).

[0148] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are only used to illustrate the present invention and are not intended to limit the scope of the present invention. The experimental methods in the following examples without specifying specific conditions are usually carried out according to conventional conditions or conditions recommended by the manufacturer.

[0149] Unless otherwise defined, all professional and scientific terms used herein have the same meanings as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to those described herein can be applied to the methods of the present invention. The preferred implementation methods and materials described herein are for demonstration purposes only.

[0150] The above features mentioned in the present invention or the features mentioned in the embodiments can be combined in any way. All the features disclosed in this patent specification can be used in combination with any combination form, and each feature disclosed in the specification can be replaced by any alternative feature that can provide the same, equal or similar purpose. Therefore, unless otherwise specified, the disclosed features are only general examples of equal or similar features.

[0151] Example

[0152] 1. Experimental Materials

[0153] 1.1 Test products, reference products and reagents

[0154] Test drugs: HX02 (FZHY) batch number: 220930, provided by Shanghai Huanghai Pharmaceutical Co., Ltd., prepared with reference to CN99113887.2 and CN200610106720.1 (the contents of the above two patents are introduced into this patent in full); ambroxol hydrochloride oral solution (batch number 2112020J China Resources Sanjiu (Nanchang) Pharmaceutical Co., Ltd.); Kyoto Nissin Mi Lian Chuanbei Loquat Paste (batch number 2112020J China Resources Sanjiu (Nanchang) Pharmaceutical Co., Ltd.); dexamethasone acetate (batch number 200906 Zhejiang Xianju Pharmaceutical Co., Ltd.); phenol red (batch number: P1380830); ammonia water (batch number: 20170308) cigarettes (Shandong China Tobacco Industry Co., Ltd.).

[0155] 1.2 Experimental animals

[0156] ICR mice SPF grade, 180 males, weighing 18g, Shanghai Shengchang Biotechnology Co., Ltd., animal certificate number 20210002001987; Balb / c mice SPF grade, 100 females, weighing 18g, Shanghai Shengchang Biotechnology Co., Ltd., animal certificate number: 20210002002528. This experiment was approved by the Animal Ethics Committee of this institute. The animals were kept in a barrier system, and the environmental conditions of the animal room were controlled at room temperature of 20℃-26℃ and humidity of 40%-70%. The lighting in the animal room alternated between 12 / 12 hours of light and dark cycles.

[0157] 1.3 Instruments

[0158] Table 1 Instrument list

[0159] Instrument Name model Manufacturer ELISA reader VARIOSKAN FLASH Thermo Multifunctional cough and wheezing induction instrument YLS-8A Jinan Yiyan Technology Co., Ltd.

[0160] 2. Experimental Methods

[0161] 2.1 Expectorant effect on mice (phenol red method)

[0162] 2.1.1 Animal grouping

[0163] After the mice were adaptively fed, 70 mice were divided into 7 groups, namely, blank control group, model group, ambroxol hydrochloride group, honey-refined Chuanbei loquat paste group, HX02 (FZHY) 0.5g / kg, 1g / kg, 2g / kg group), with 10 mice in each group. The experimental group was given oral administration, and the model group and blank control group were given an equal volume of normal saline.

[0164] 2.1.2 Modeling and testing indicators

[0165] Each group of mice was given drugs by oral gavage, 0.2 ml / 10 g body weight for 14 consecutive days. 30 minutes after the last administration, 0.1 ml / 10 g of phenol red solution was injected intraperitoneally. The animals were killed 30 minutes later, the trachea was dissected and separated, and a flattened No. 7 needle was inserted into the trachea 0.3 cm, tied with silk thread, and 5% sodium bicarbonate solution was drawn with a 1 ml syringe, 0.5 ml, and the respiratory tract was irrigated back and forth through the needle 3 times. The irrigating fluid was drawn out and injected into a test tube for the last time. The above operation was repeated 3 times, and about 1 ml of irrigating fluid was drawn and placed in a test tube, centrifuged, and 150 ul of supernatant was drawn into a 96-well plate. The OD value at 546 nm was detected with an enzyme marker and zeroed with 5% sodium bicarbonate solution.

[0166] 2.2 Antitussive effect on mice (ammonia method)

[0167] 2.2.1 Animal grouping

[0168] After the mice were adaptively fed, 70 mice were divided into 70 groups, namely, blank control group, model group, ambroxol hydrochloride group, honey-refined Chuanbei loquat paste group, and HX02 (FZHY) (0.5g / kg, 1g / kg, 2g / kg group), with 10 mice in each group. The experimental group was given oral administration, and the model group and blank control group were given an equal volume of normal saline.

[0169] 2.2.2 Modeling and testing indicators

[0170] Each group of mice was given drugs by oral gavage, 0.2 ml / 10 g body weight for 14 consecutive days. One hour after the last administration, the mice were placed in a YLS-8A multifunctional cough and wheeze induction instrument and atomized with 12% ammonia for 10 seconds. The cough latency and the number of coughs within 2 minutes of the mice were observed and recorded.

[0171] 2.3 Effects on chronic bronchitis in mice

[0172] 2.3.1 Animal grouping

[0173] After the mice were adaptively fed, 50 mice were divided into 5 groups, namely, blank control group, model group, dexamethasone acetate group (2g / kg group), T-HX02 (2g / kg group, T represents pre-administration), HX02 (FZHY) (2g / kg group), with 10 mice in each group. The experimental group was given intragastric administration, and the model group and blank control group were given an equal volume of normal saline.

[0174] 2.3.2 Modeling and testing indicators

[0175] Each group of mice was orally gavaged, and the model was established at the same time, for 21 consecutive days, 0.2ml / 10g body weight. (Mice that were given the drug two weeks in advance were given the drug for a total of 35 days, and the model was established 2 weeks after the pre-drug)

[0176] Put the cigarette into the smoke generator (20 cigarettes / time), and place the mouse in the aerosol inhalation box. The size of the aerosol box is 60 cm × 60 cm × 80 cm. After lighting the cigarette, the smoke is injected into the poison box through the automatic suction of the syringe, and all of it is burned out within five minutes. Twice a day, morning and evening, 30 minutes each time, with an interval of more than 4 hours, for 3 consecutive weeks.

[0177] One hour after the last administration of the mice, the mice were anesthetized and killed, and the trachea was separated. The whole lung was completely removed, fixed in formalin solution, dehydrated, embedded, sectioned, and HE stained.

[0178] The HE-stained pathological tissue sections were observed under a light microscope and graded according to Table 2.

[0179] Table 2 Pathological grading of H.E. staining

[0180]

[0181] 2.3.3 Data collation

[0182] The data were collated in Office Excel 2013 and GraphPad Prism6.0. When two groups were compared, T-test was used for two-tailed test. When p<0.05, there was a significant difference between the two groups.

[0183] 3. Experimental results

[0184] 3.1 Effect of HX02(FZHY) on expectoration in mice (phenol red method)

[0185] from Figure 1 As can be seen from Table 3, Kyoto Nissin Mi Lian Chuanbei Loquat Paste can increase the tracheal phenol red secretion of mice, which is significantly different from the model group (P<0.01); 2.57ml / kg ambroxol hydrochloride oral solution has a certain promoting effect on the tracheal phenol red secretion of mice, which is significantly different from the model group (P<0.01); 0.5g / kg, 1g / kg, 2g / kg groups of HX02 (FZHY) can increase the tracheal phenol red secretion of mice, which is significantly different from the model group (P<0.01, P<0.05).

[0186] Table 3 Expectorant effect in mice (n=10, mean ± SD)

[0187] Group dose OD Model Group / 0.035±0.019 Ambroxol Hydrochloride Oral Solution 2.57ml / kg 0.091±0.078** Kyoto Nien Jiom Honey Refined Chuanbei Loquat Paste 5.8ml / kg 0.146±0.045** HX02(FZHY) 2g / kg 0.169±0.085** HX02(FZHY) 1g / kg 0.144±0.043** HX02(FZHY) 0.5g / kg 0.114±0.065*

[0188] The results showed that HX0-2 could increase the secretion of phenol red in the mouse trachea, and the dose-effect relationship was good.

[0189] 3.2 Antitussive effect on mice (ammonia method)

[0190] 3.2.1 Effect on the cough latency period of mice

[0191] from Figure 2 As can be seen from Table 4, 1.03 tablets / kg of dextromethorphan hydrobromide and 5.8 ml / kg of Kyoto Nissin Honey-Refined Chuanbei Loquat Paste can prolong the cough latency of mice, which is significantly different from the model group (P<0.05); 2g / kg, 1g / kg, and 0.5g / kg of HX02 (FZHY) can prolong the cough latency of mice, and 2g / kg and 1g / kg are significantly different from the model group (P<0.01).

[0192] Table 4 Effect of cough latency in mice (n=10, mean ± SD)

[0193] Group dose Incubation period (S) Model Group / 26.4±4.0 1.03 tablets / kg Dextromethorphan Hydrobromide Tablets 1.03 pieces / kg 33.1±5.0* 5.8ml / kg Kyoto Nien Jiom Honey Refined Chuanbei Loquat Paste 5.8ml / kg 33.0±6.0* HX02(FZHY) 2g / kg 35.1±5.8** HX02(FZHY) 1g / kg 34.7±6.9** HX02(FZHY) 0.5g / kg 30.8±4.5

[0194] Note: The incubation period of the blank control group is 120 seconds, which is not described here.

[0195] 3.2.2 Effect on the number of coughs in mice

[0196] from Figure 3 As can be seen from Table 5, when mice were given 1.03 tablets / kg of dextromethorphan hydrobromide, 5.8 ml / kg of Kyoto Nissin Mi Lian Chuanbei Loquat Paste, and various doses of FZHY for 14 consecutive days, the number of coughs in mice was reduced, which was significantly different from that in the model group (P<0.01).

[0197] Table 5 Effect of the total number of coughs in mice within 2 minutes (n=10, mean ± SD)

[0198] Group dose Number of coughs (times) Model Group / 31.4±5.9 1.03 tablets / kg Dextromethorphan Hydrobromide Tablets 1.03 pieces / kg 17.5±3.0** 5.8ml / kg Kyoto Nien Jiom Honey Refined Chuanbei Loquat Paste 5.8ml / kg 18.8±3.5** HX02(FZHY) 2g / kg 21.5±3.8** HX02(FZHY) 1g / kg 19.7±3.0** HX02(FZHY) 0.5g / kg 21.5±3.2**

[0199] Note: The number of coughs in the blank control group was 0 and is not described here.

[0200] The results showed that FZHY can reduce the frequency of coughing and has a certain antitussive effect.

[0201] 3.3 Effects on chronic bronchitis in mice

[0202] 3.3.1 Effect on the body weight of model mice

[0203] The results are as follows Figure 4 As shown. Smoking slightly affected the body weight of mice, but except for the dexamethasone group, the body weight loss at the end of the first, second and third weeks was significantly different from that of the blank control group (P<0.05, P<0.01, P<0.01). There was no significant difference in body weight between the other groups and the blank group.

[0204] 3.3.2 Effect of lung pathology scores on model mice

[0205] The results are as follows Figure 5 and as shown in Table 6. Blank control group ( Figure 5 A) The bronchial morphology was basically normal under the observation of lung HE section microscope, and the cells were arranged neatly. No pathological changes such as thickening, degeneration, necrosis and inflammatory cell infiltration were observed. Model group ( Figure 5 B) There was more bleeding in the alveolar cavity, inflammatory cell infiltration, obvious destruction of tissue structure, alveolar collapse, changes in the morphology of the bronchial wall, and incomplete mucosal structure. Figure 5 C) Alveolar septa widened, inflammatory cells infiltrated part of the lung, and the tissue structure was normal. Figure 5 D) Inflammatory cells infiltrated the lungs, the tissue structure was still destroyed, the morphology of the bronchial wall changed, and the mucosal structure was incomplete. Figure 5 E) Alveolar septa were widened, inflammatory cells infiltrated part of the lung, the tissue structure was normal, and a small amount of inflammatory cells infiltrated the mucosal layer. Ridit analysis was performed based on the scores, and the statistical results in Table 6 were obtained.

[0206] Table 6 Effects of chronic bronchitis on the lungs of mice

[0207]

[0208] The results showed that HX02 (FZHY) could improve the inflammatory exudation in the lungs of mice with chronic bronchitis and maintain the integrity and morphology of the bronchial wall.

[0209] The embodiments of the present invention are described in detail above. Specific examples are used herein to illustrate the principles and implementation methods of the present invention. The description of the above embodiments is only used to help understand the method of the present invention and its core idea. At the same time, changes or deformations made by those skilled in the art based on the ideas of the present invention, the specific implementation methods and application scope of the present invention, all belong to the scope of protection of the present invention. In summary, the content of this specification should not be understood as limiting the present invention.

Claims

1. A pharmaceutical composition for use in preventing and treating lung diseases, characterized in that: The raw materials of the pharmaceutical composition include, by weight: 50-250 parts of peach kernel, 300-700 parts of salvia miltiorrhiza, 200-600 parts of gynostemma pentaphyllum, 150-450 parts of fermented cordyceps powder, 50-250 parts of pine pollen, 50-250 parts of schisandra chinensis, and an appropriate amount of starch.

2. The use according to claim 1, characterized in that In parts by weight, the raw materials of the pharmaceutical composition include: 100-200 parts of peach kernel, 500-600 parts of salvia miltiorrhiza, 300-500 parts of gynostemma pentaphyllum, 200-300 parts of fermented cordyceps powder, 100-200 parts of pine pollen, 100-200 parts of schisandra chinensis, and an appropriate amount of starch; Preferably, in parts by weight, the raw materials of the pharmaceutical composition include: about 130 parts of peach kernel, about 530 parts of salvia miltiorrhiza, about 400 parts of gynostemma pentaphyllum, about 260 parts of fermented cordyceps powder, about 130 parts of pine pollen, about 130 parts of schisandra chinensis, and an appropriate amount of starch.

3. Use of a pharmaceutical composition in preventing and treating lung diseases, characterized in that: The pharmaceutical composition is prepared by adding the following Chinese herbal extracts in the following weight percentage ratios as the active ingredients of the medicine, and adding auxiliary materials: 25-55% of salvia miltiorrhiza extract, 12-40% of gynostemma pentaphyllum extract, 5-12% of schisandra chinensis alcohol extract, 12-30% of cordyceps mycelium extract, 6-12% of pine pollen extract, 5-30% of peach kernel extract, and the rest as auxiliary materials; The above-mentioned pharmaceutical compound preparation wherein each effective component is prepared by the following method: ① Salvia miltiorrhiza extract Take Danshen medicinal material, crush it into granules, add about 12 times of water, extract twice at 95℃±2, combine the extracts and concentrate for later use. After testing, it is found that the water-soluble components of Danshen are mainly salvianolic acid B and sodium danshensu. Add about 70% ethanol to the residues and reflux twice, each time for about 1 hour, combine the extracts and concentrate for later use. After testing, the fat-soluble components of Danshen are mainly tanshinone. Combine the concentrated solutions and dry them for later use. ② Gynostemma pentaphyllum extract After the Gynostemma pentaphyllum medicinal material is soaked in about 75% ethanol, high-frequency ultrasonic extraction is performed three times to obtain the Gynostemma pentaphyllum extract, and the main component is total saponin after testing; ③Schisandra chinensis ethanol extract The raw material of Schisandra chinensis is added with about 80% ethanol for reflux extraction twice, and the extract is dried after the ethanol is recovered, and then crushed to obtain fine powder. After testing, the lignan components in Schisandra chinensis belong to the biphenylcyclooctene type lignan components, and Schisandrin A is the main component; the extraction rate of Schisandrin A by reflux extraction with about 80% ethanol is 0.3% to 2.0%; ④Cordyceps mycelium extract Take the Cordyceps mycelium raw material, add about 75% ethanol and warm extract three times, combine the extracts, recover the ethanol, and dry the extracts for later use; ⑤Pine pollen lipid extract Using about 70% ethanol to reflux heat to extract pine pollen, recovering ethanol from the extract, and drying the extract for later use; ⑥Peach kernel extract The effective components of the traditional Chinese medicine peach kernel are water-soluble components. The peach kernel is decocted twice with about 10 times the amount of water by water decoction method, and the extract is concentrated into an extract, and the extract is dried for later use. The above-mentioned extracts are dried by vacuum drying or spray drying. Preferably, the weight percentages of the active ingredients of the drug are: about 38% of salvia miltiorrhiza extract, about 25% of gynostemma pentaphyllum extract, about 6% of schisandra chinensis ethanol extract, about 19% of cordyceps mycelium extract, about 6% of pine pollen extract and about 6% of peach kernel extract; More preferably, the salvia miltiorrhiza extract contains 2.5-10% salvianolic acid B; the schisandra chinensis extract contains 0.3-2.0% schisandra alcohol A; the cordyceps mycelium extract contains 0.1-5.0% adenosine; and the gynostemma pentaphyllum extract contains 0.5-8.0% total saponins.

4. The use according to any one of claims 1 to 3, characterized in that The pharmaceutical composition further comprises one or more drugs and / or extracts for preventing and treating lung diseases; Preferably, the drug is selected from one or more of the following: antibiotics, bronchodilators, glucocorticoids, antitussive and expectorant drugs, and antiasthmatic drugs; More preferably, the antibiotic is selected from one or more of the following: quinolone antibiotics, macrolide antibiotics and beta-lactam antibiotics; More preferably, the bronchodilator is salbutamol sulfate and / or terbutaline sulfate; More preferably, the glucocorticoid is prednisolone acetate; More preferably, the antitussive and expectorant is compound liquorice mixture, bromhexine, ambroxol hydrochloride, myrtle oil and / or dextromethorphan; More preferably, the antiasthmatic drug is aminophylline.

5. The use according to any one of claims 3, characterized in that The pharmaceutical composition further comprises one or more pharmaceutically acceptable excipients; Preferably, the excipient is selected from one or more of the following: diluent, wetting agent, binder, disintegrant, inclusion agent, flavoring agent, sustained-release agent, retention agent, lubricant, dispersant, plasticizer, opacifier and antioxidant; More preferably, the pharmaceutical composition is in the form of powder, tablet, pill, capsule, film, lozenge, granule, injection or oral solution; More preferably, the dosage form of the pharmaceutical composition is a capsule or a tablet; Also preferably, the tablet is a dispersible tablet or a sustained-release tablet.

6. The use according to claim 1 or 2, characterized in that: The preparation method of the pharmaceutical composition comprises the following steps: (1) adding water to decoct the salvia miltiorrhiza, peach kernel and gynostemma pentaphyllum weighed in weight ratio, combining the decoctions, taking the supernatant, concentrating it into an extract, cooling it, adding ethanol, precipitating it and filtering it; (2) weighing another portion of the fermented Cordyceps sinensis powder, adding ethanol to Schisandra chinensis and refluxing, cooling, combining the ethanol solution, filtering, and concentrating the filtrate to dryness; (3) weighing pine pollen and adding ethanol to warm immerse, combining the leaching solution, concentrating and drying to form a dry paste; and (4) Take the above three dry pastes, mix and grind them, add an appropriate amount of starch, mix well, and obtain the pharmaceutical composition.

7. The use according to any one of claims 1 to 3, characterized in that The pulmonary diseases include bronchitis, tuberculosis, pulmonary embolism, asthma, pneumonia and / or lung cancer; Preferably, the bronchitis is acute bronchitis or chronic bronchitis.

8. The use according to any one of claims 1 to 3, characterized in that The pulmonary disease is a pulmonary disease with clinical symptoms of cough and / or sputum.

9. The use according to any one of claims 1 to 3, characterized in that The lung disease is a lung disease caused by smoking, haze or other smoke factors.

10. Use of a pharmaceutical composition in the preparation of a drug for maintaining the integrity and morphology of bronchial walls and / or reducing inflammatory cell infiltration, characterized in that: In parts by weight, the raw materials of the pharmaceutical composition include: 50-250 parts of peach kernel, 300-700 parts of salvia miltiorrhiza, 200-600 parts of gynostemma pentaphyllum, 150-450 parts of fermented cordyceps powder, 50-250 parts of pine pollen, 50-250 parts of schisandra chinensis, and an appropriate amount of starch; Alternatively, the pharmaceutical composition is prepared by adding the following Chinese herbal extracts in the following weight percentage ratios as the active ingredients, and adding excipients: 25-55% of Salvia miltiorrhiza extract, 12-40% of Gynostemma pentaphyllum extract, 5-12% of Schisandra chinensis alcohol extract, 12-30% of Cordyceps mycelium extract, 6-12% of pine pollen extract, 5-30% of peach kernel extract, and the rest as excipients; The above-mentioned pharmaceutical compound preparation wherein each effective component is prepared by the following method: ② Salvia miltiorrhiza extract Take Danshen medicinal material, crush it into granules, add about 12 times of water, extract twice at 95℃±2, combine the extracts and concentrate for later use. After testing, it is found that the water-soluble components of Danshen are mainly salvianolic acid B and sodium danshensu. Add about 70% ethanol to the residues and reflux twice, each time for about 1 hour, combine the extracts and concentrate for later use. After testing, the fat-soluble components of Danshen are mainly tanshinone. Combine the concentrated solutions and dry them for later use. ② Gynostemma pentaphyllum extract After the Gynostemma pentaphyllum medicinal material is soaked in about 75% ethanol, high-frequency ultrasonic extraction is performed three times to obtain the Gynostemma pentaphyllum extract, and the main component is total saponin after testing; ③Schisandra chinensis ethanol extract The raw material of Schisandra chinensis is added with about 80% ethanol for reflux extraction twice, and the extract is dried after the ethanol is recovered, and then crushed to obtain fine powder. After testing, the lignan components in Schisandra chinensis belong to the biphenylcyclooctene type lignan components, and Schisandrin A is the main component; the extraction rate of Schisandrin A by reflux extraction with about 80% ethanol is 0.3% to 2.0%; ④Cordyceps mycelium extract Take the Cordyceps mycelium raw material, add about 75% ethanol and warm extract three times, combine the extracts, recover the ethanol, and dry the extracts for later use; ⑤Pine pollen lipid extract Using about 70% ethanol to reflux heat to extract pine pollen, recovering ethanol from the extract, and drying the extract for later use; ⑥Peach kernel extract The effective components of the traditional Chinese medicine peach kernel are water-soluble components. The peach kernel is decocted twice with about 10 times the amount of water by water decoction method, and the extract is concentrated into an extract, and the extract is dried for later use. The above-mentioned extracts are dried by vacuum drying or spray drying.

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