Traditional Chinese medicine composition, traditional Chinese medicine extract and preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition, a traditional Chinese medicine extract and a preparation method and application thereof. Specifically, the invention provides a traditional Chinese medicine composition, and the traditional Chinese medicine composition comprises the following components in parts by weight: 300-500 parts of salvia miltiorrhiza; the bo-chrysanthemum is 300 to 500 parts by weight; 500-700 parts by weight of radix astragali seu hedysari; and / or 700-900 parts by weight of radix scutellariae.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition, a traditional Chinese medicine extract, and a preparation method and use thereof. Background Art

[0002] Pneumonia refers to inflammation of the terminal airways, alveoli and lung interstitium, which can be caused by pathogenic microorganisms, physical and chemical factors, immune damage, allergies and drugs. Pneumonia in daily life mainly refers to pneumonia caused by bacterial infection. This pneumonia is the most common type and one of the most common infectious diseases. It poses a great threat to the health of children and the elderly. Pediatric pneumonia is listed as one of the three most important pediatric diseases by the World Health Organization. It is also one of the four pediatric diseases that the Ministry of Health of my country requires to be focused on prevention and treatment. Clinically, it has the characteristics of high incidence and easy recurrence.

[0003] At present, Western medicine mainly uses antibiotics to treat patients with bacterial pneumonia, and antibiotics once significantly reduced the mortality rate of pneumonia. However, in recent years, despite the use of powerful antibiotics and effective vaccines, the overall mortality rate of pneumonia has not decreased, and has even increased. This may be related to its side effects such as increased drug resistance and dysbiosis.

[0004] Therefore, there is an urgent need in the art to develop new drugs that can enhance immunity, change lung circulation, and effectively treat pneumonia and / or upper respiratory tract inflammation and its symptoms. Summary of the invention

[0005] The purpose of the present invention is to provide a Chinese medicine composition, a Chinese medicine extract and a preparation method and use thereof. The Chinese medicine composition or its extract has excellent therapeutic effects on pneumonia and / or upper respiratory tract inflammation and its symptoms.

[0006] The first aspect of the present invention provides a traditional Chinese medicine composition, comprising:

[0007] Salvia miltiorrhiza is 300-500 parts by weight;

[0008] Boju is 300-500 parts by weight;

[0009] 500-700 parts by weight of Astragalus; and / or

[0010] The amount of Scutellaria baicalensis is 700-900 parts by weight.

[0011] In another preferred example, the Chinese medicine composition comprises 350-450 parts by weight of Salvia miltiorrhiza, 350-450 parts by weight of Boju, 550-650 parts by weight of Astragalus and 750-850 parts by weight of Scutellaria baicalensis.

[0012] In another preferred example, the Chinese medicine composition comprises 400 parts by weight of Salvia miltiorrhiza, 400 parts by weight of Boju, 600 parts by weight of Astragalus and 800 parts by weight of Scutellaria baicalensis.

[0013] In a second aspect of the present invention, a Chinese medicine extract is provided, wherein the Chinese medicine extract is extracted from the Chinese medicine composition as described in the first aspect.

[0014] In another preferred embodiment, the Chinese herbal medicine extracts include extracts of Salvia miltiorrhiza, Boju, Astragalus and / or Scutellaria baicalensis.

[0015] In another preferred embodiment, the Chinese herbal medicine extract contains ingredients selected from the following group: baicalein, wogonin, quercetin, luteolin, cryptotanshinone, tanshinone ⅡA, astragaloside IV, astragaloside polysaccharide, or a combination thereof.

[0016] In another preferred embodiment, the Chinese herbal medicine extract contains ingredients selected from the following group:

[0017] The content of baicalin is 0.4-0.6%, based on the total weight of the Chinese medicine extract;

[0018] The content of quercetin is 0.16-0.36%, based on the total weight of the Chinese medicine extract;

[0019] The content of luteolin is 0.045-0.065%, based on the total weight of the traditional Chinese medicine extract;

[0020] The content of wogonin is 0.1-0.3%, based on the total weight of the Chinese medicine extract;

[0021] The content of cryptotanshinone is 0.06-0.08%, based on the total weight of the traditional Chinese medicine extract;

[0022] The content of tanshinone ⅡA is 0.06-0.08%, based on the total weight of the traditional Chinese medicine extract;

[0023] The content of astragaloside IV is 0.08-0.1%, based on the total weight of the traditional Chinese medicine extract;

[0024] The content of astragalus polysaccharide is 2.6-3%, calculated on the total weight of the traditional Chinese medicine extract.

[0025] In another preferred example, the content of baicalein is 0.514%, based on the total weight of the traditional Chinese medicine extract.

[0026] In another preferred embodiment, the content of quercetin is 0.261%, based on the total weight of the traditional Chinese medicine extract.

[0027] In another preferred embodiment, the content of luteolin is 0.056%, based on the total weight of the traditional Chinese medicine extract.

[0028] In another preferred example, the content of wogonin is 0.183%, based on the total weight of the traditional Chinese medicine extract.

[0029] In another preferred embodiment, the content of cryptotanshinone is 0.068%, based on the total weight of the traditional Chinese medicine extract.

[0030] In another preferred example, the content of tanshinone ⅡA is 0.070%, based on the total weight of the traditional Chinese medicine extract.

[0031] In another preferred embodiment, the content of astragaloside IV is 0.086%, based on the total weight of the traditional Chinese medicine extract.

[0032] In another preferred embodiment, the content of astragalus polysaccharide is 2.81%, based on the total weight of the traditional Chinese medicine extract.

[0033] In a third aspect of the present invention, there is provided a method for preparing the Chinese medicine extract as described in the second aspect, comprising the steps of:

[0034] (S1) extracting Astragalus membranaceus using a first extraction solvent to obtain a dry extract powder A;

[0035] (S2) extracting Scutellaria baicalensis, Salvia miltiorrhiza, and Bohemia radix with a second extraction solvent to obtain a dry extract powder B;

[0036] (S3) The dry extract powder A and the dry extract powder B are mixed and granulated to obtain the Chinese herbal medicine extract.

[0037] In another preferred embodiment, the Chinese herbal medicine extract also includes a binder and / or starch.

[0038] In another preferred example, the binder is ethanol.

[0039] In another preferred embodiment, the weight ratio of the traditional Chinese medicine composition to the extraction solvent is 1:5-20, preferably 1:5-15.

[0040] In another preferred embodiment, in step (S1), the Chinese medicine composition is extracted with a first extraction solvent selected from the group consisting of water, alcohol, or alcohol-water solution to obtain an extract.

[0041] In another preferred embodiment, in step (S1), the alcohol content in the alcohol aqueous solution is 3.0-98% (v / v), preferably 40-98% (v / v), more preferably 50-90% (v / v), and most preferably 60-80% (v / v).

[0042] In another preferred embodiment, the alcohol is a C1-C6 lower alcohol, preferably a C1-C4 lower alcohol, and more preferably a C1-C3 lower alcohol.

[0043] In another preferred embodiment, the alcohol is ethanol.

[0044] In another preferred embodiment, the step (S2) further comprises the steps of:

[0045] (S2a) extracting the Chinese medicine composition with a second extraction solvent selected from the group consisting of water, alcohol or alcohol-water solution to obtain an extract;

[0046] The extract described in (S2b) is purified by a macroporous adsorption resin column to obtain an extract.

[0047] In another preferred embodiment, in step (S2a), the alcohol content in the alcohol aqueous solution is 10-90% (v / v), preferably 20-80% (v / v), more preferably 30-70% (v / v), and most preferably 40-60% (v / v).

[0048] In another preferred embodiment, the extraction solvent is C1-C6 lower alcohol, preferably C1-C4 lower alcohol, and more preferably C1-C3 lower alcohol.

[0049] In another preferred embodiment, the alcohol is ethanol.

[0050] In another preferred embodiment, in step (S2b), during the macroporous adsorption resin column purification process, the eluent is an alcohol aqueous solution.

[0051] In another preferred embodiment, in the step (S2b), the alcohol content in the alcohol-water solution in the eluent is 40-98% (v / v).

[0052] In another preferred embodiment, the macroporous adsorption resin column is a styrene-type weakly polar macroporous adsorption resin column.

[0053] In another preferred embodiment, the styrene-type weak polar macroporous adsorption resin column is an AB-8 styrene-type weak polar macroporous adsorption resin column.

[0054] In another preferred embodiment, in the step (S2b), the column diameter-to-height ratio of the macroporous adsorption resin column is 1:2-3.5.

[0055] In another preferred embodiment, the volume of the resin column is 0.8-2L.

[0056] In another preferred embodiment, during the purification process of the macroporous adsorption resin column, 0.2-1.2 times the column volume of water is first used for impurity removal, the water impurity removal eluate is discarded, and then eluted with 2-6 times 40-80% (v / v) C1-C3 lower alcohol aqueous solution and 6-10 times 85-98% (v / v) C1-C3 lower alcohol aqueous solution in sequence, the alcohol water eluate is collected, and concentrated to obtain the extract.

[0057] In another preferred embodiment, after removing the solvent from the alcohol-water eluent, a Chinese medicine extract is obtained.

[0058] In a fourth aspect of the present invention, there is provided a use of the Chinese medicine composition as described in the first aspect and / or the Chinese medicine extract as described in the second aspect for preparing a pharmaceutical composition or preparation, wherein the pharmaceutical composition or preparation is used for: (i) preventing and / or treating inflammation; and / or (ii) preventing and / or treating symptoms caused by inflammation;

[0059] The inflammation is upper respiratory tract inflammation and / or pneumonia.

[0060] In another preferred embodiment, the inflammation is caused by bacterial infection.

[0061] In another preferred embodiment, the bacteria is selected from the group consisting of Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, or a combination thereof.

[0062] In another preferred embodiment, the symptom is selected from the group consisting of fever, cough, sputum, inflammation, asthma, or a combination thereof.

[0063] In another preferred embodiment, the pharmaceutical composition or preparation is used for: (a) antipyretic; (b) anti-inflammatory; (c) antitussive; and / or (d) expectorant;

[0064] In the fifth aspect of the present invention, a pharmaceutical composition or preparation for preventing and / or treating inflammation, and / or preventing and / or treating symptoms caused by inflammation is provided, comprising the Chinese medicine composition as described in the first aspect or the drug extract as described in the second aspect; and a pharmaceutically acceptable carrier; wherein the inflammation is upper respiratory tract inflammation and / or pneumonia.

[0065] In another preferred embodiment, the preparation is selected from the following group: granules, capsules or tablets.

[0066] In another preferred embodiment, in the pharmaceutical composition or preparation, the content of the traditional Chinese medicine composition or traditional Chinese medicine extract is 0.1-99.9wt%, preferably 1-99%, more preferably 5-95%, more preferably 10-90%, more preferably 20-80%, and optimally 30-70%, based on the weight of the pharmaceutical composition.

[0067] The sixth aspect of the present invention provides a method for preventing and / or treating pneumonia, and / or preventing and / or treating symptoms caused by pneumonia, by administering the Chinese medicine composition as described in the first aspect and / or the Chinese medicine extract as described in the second aspect to a subject in need.

[0068] In another preferred embodiment, the subject is a human or non-human mammal.

[0069] It should be understood that within the scope of the present invention, the above-mentioned technical features of the present invention and the technical features specifically described below (such as embodiments) can be combined with each other to form a new or preferred technical solution. Due to space limitations, they will not be described one by one here. BRIEF DESCRIPTION OF THE DRAWINGS

[0070] Figure 1 This is the HPLC chromatogram of the Shuanghuangdanjufang sample and the mixed reference substance. Figure 1 A is the HPLC chromatogram of the mixed reference substance. Figure 1 B is the HPLC chromatogram of the Shuanghuangdanju prescription sample.

[0071] Figure 2 This is the HPLC chromatogram of the Shuanghuangdanjufang sample and the astragaloside IV reference substance. Figure 2 A is the HPLC chromatogram of astragaloside IV reference substance, Figure 2 B is the HPLC chromatogram of the Shuanghuangdanju prescription sample.

[0072] Figure 3 It is a glucose linear relationship graph. DETAILED DESCRIPTION

[0073] After extensive and in-depth research, the inventors unexpectedly discovered a Chinese medicine composition or its extract and its use, which is used for (i) preventing and / or treating upper respiratory tract inflammation or pneumonia; and / or (ii) preventing and / or treating symptoms caused by upper respiratory tract inflammation or pneumonia; the Chinese medicine composition comprises one or more medicinal materials selected from the following group: Scutellaria baicalensis, Astragalus membranaceus, Salvia miltiorrhiza and Botrytis cinerea. The experimental results of the present invention show that the Chinese medicine extract of the present invention has unexpected effects such as anti-inflammatory and antibacterial. Therefore, the Chinese medicine composition of the present invention or its extract has excellent therapeutic effects on upper respiratory tract inflammation or pneumonia. The present invention was completed on this basis.

[0074] the term

[0075] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0076] As used herein, the terms "comprise", "include", and "contain" are used interchangeably and include not only closed definitions, but also semi-closed and open definitions. In other words, the terms include "consisting of", "consisting essentially of".

[0077] In the present invention, the term "prevention" means a method of preventing the onset of a disease and / or its attendant symptoms or protecting a subject from acquiring a disease. "Prevention" as used herein also includes delaying the onset of a disease and / or its attendant symptoms and reducing the risk of a subject acquiring a disease.

[0078] The "treatment" described in the present invention includes delaying and stopping the progression of the disease, or eliminating the disease, and does not require 100% inhibition, elimination and reversal. In some embodiments, the composition or pharmaceutical composition of the present invention reduces, inhibits and / or reverses diabetes and its complications by, for example, at least about 10%, at least about 30%, at least about 50%, or at least about 80%, compared to the levels observed when the composition, medicine kit, food kit or health product kit, active ingredient combination described in the present invention is not present.

[0079] As used herein, the term "effective amount" refers to an amount that produces a function or activity in humans and / or animals and is acceptable to humans and / or animals. It should be understood by those skilled in the art that the "effective amount" may vary depending on the form of the pharmaceutical composition, the severity of the disease, and the combination of other drugs.

[0080] As used herein, the terms "parts by weight" and "parts by weight" are used interchangeably, and the parts by weight may be any fixed weight expressed in milligrams, grams or kilograms (such as 1 mg, 1 g, 2 g or 1 kg, etc.). For example, a composition consisting of 1 part by weight of component a and 9 parts by weight of component b may be a composition consisting of 1 gram of component a + 9 grams of component b, or 10 grams of component a + 90 grams of component b, etc. In the composition, the percentage content of a component = (parts by weight of the component / sum of the parts by weight of all components) × 100%. Therefore, in a composition consisting of 1 part by weight of component a and 9 parts by weight of component b, the content of component a is 10%, and the content of component b is 90%.

[0081] As used herein, the term "Chinese medicine composition" refers to the Chinese medicine used as the active medicinal material in the present invention, and the medicinal material may include various forms, for example, the medicinal material includes (but is not limited to) dry medicinal materials, fresh medicinal materials, raw medicinal materials, cooked medicinal materials, processed medicinal materials, or a combination thereof. In addition, when the pharmaceutical composition or preparation of the present invention contains a certain Chinese medicine extract, the term also includes the raw medicinal materials corresponding to the Chinese medicine extract or the corresponding Chinese medicine composition used to prepare the extract.

[0082] As used herein, the term "C1-C6 lower alcohol", "C1-C4 lower alcohol" or "C1-C3 lower alcohol" refers to an alcohol having 1-6, 1-4 or 1-3 carbon atoms, such as methanol, ethanol, n-propanol, isopropanol, or n-butanol.

[0083] Bacterial pneumonia

[0084] In traditional Chinese medicine, bacterial pneumonia is classified into the categories of "exogenous fever, cough, and wheezing" according to different symptoms. The causes are mostly related to climate change, abnormal cold and temperature, and the strength of the body's positive energy. If you are not careful about your daily life, the cold and temperature are not adjusted, and you are overworked, the function of defending the body will be weakened, making you susceptible to external evil. The lungs are responsible for the defense of qi, and the invasion of external evil first attacks the lungs, and the defense qi fails to spread. The pathogenesis of bacterial pneumonia is insufficient positive energy, and the evil wind takes advantage of the opportunity to enter, resulting in the failure of lung qi to spread, and the accumulation of phlegm and heat. Traditional Chinese medicine treatment can improve immunity and lung circulation. It can also determine different treatment plans according to the different symptoms of the disease, which is tailored to the individual and has certain advantages.

[0085] Chinese medicine composition and Chinese medicine extract

[0086] The Chinese medicine compound of the present invention is composed of four herbs, namely, scutellaria baicalensis, astragalus, salvia miltiorrhiza and chrysanthemum, and is referred to as Shuanghuang Danju prescription. Scutellaria baicalensis is bitter in taste and cold in nature, clears away heat and dries dampness, is light in quality and floats upward, and mainly clears lung heat to stop cough and help eliminate phlegm; astragalus is sweet in nature and warm in nature, and belongs to the lung and spleen meridians, and can replenish qi and raise yang, and invigorate qi and consolidate the exterior; salvia miltiorrhiza is bitter in taste and cold in nature, and is good at regulating blood, cooling blood and activating blood circulation, and removing blood stasis and stagnation, and has the effects of regulating qi and opening the orifices, unblocking meridians and stopping cough and relieving asthma; chrysanthemum is sweet, cool, light and clear, and evacuates wind-heat in the upper part of the body to promote lung qi. The four herbs play together and jointly play the effects of clearing heat, detoxifying, removing blood stasis, promoting lung qi and relieving asthma. It has a significant therapeutic effect on upper respiratory tract inflammation, pneumonia and the like.

[0087] The main chemical components of each single herb in Shuanghuang Danju Recipe are: Scutellaria baicalensis (baicalin, wogonin), Astragalus (astragaloside IV, astragaloside polysaccharide), Salvia miltiorrhiza (tanshinone ⅡA, cryptotanshinone), Boju (luteolin, quercetin). There is no report on the purification and preparation of anti-inflammatory parts from Shuanghuang Danju Recipe. The present invention enriches and purifies the flavonoids, sugars, saponins and other components in Shuanghuang Danju Recipe with macroporous adsorption resin to obtain the anti-inflammatory active part of Shuanghuang Danju Recipe. This part has a certain therapeutic effect on upper respiratory tract inflammation and pneumonia, can significantly improve the inflammation, and has the value of innovative drug research and development.

[0088] Preparation method of Chinese herbal medicine extract

[0089] Those skilled in the art can extract the Chinese medicine composition using conventional methods, including but not limited to water extraction, alcohol extraction, water-alcohol solution extraction, CO2 supercritical extraction, aqueous solvent extraction, or a combination thereof.

[0090] The raw Chinese medicine materials can be mixed and then the effective components can be extracted by appropriate methods to obtain extracts; in addition, each raw medicine material can also be extracted (e.g., using the same or different extraction or processing methods) for effective components (i.e., extracts of medicinal materials) and then combined to obtain extracts. It should be understood that the effective components obtained by extraction can exist in various forms, such as a single or mixed pure effective component powder obtained by extracting and purifying the raw medicine materials, or an extract obtained by solvent extraction and concentration of the raw medicine materials (the effective components are present in the extract), or other forms.

[0091] In a preferred embodiment of the present invention, the Chinese herbal medicine extract includes Scutellaria baicalensis extract.

[0092] In another preferred embodiment, the Chinese herbal medicine extract includes astragalus extract.

[0093] In another preferred embodiment, the Chinese herbal medicine extract includes Boju extract.

[0094] In another preferred embodiment, the Chinese herbal medicine extract includes Salvia miltiorrhiza extract.

[0095] Typically, the Chinese herbal medicine extract includes Scutellaria baicalensis extract, Astragalus membranaceus extract, Bohemia lappa extract and / or Salvia miltiorrhiza extract.

[0096] In a preferred embodiment of the present invention, the extract is obtained by extraction with an extraction solvent selected from the group consisting of: water, alcohol or alcohol-water solution.

[0097] In another preferred embodiment, the alcohol is a C1-C6 lower alcohol, preferably a C1-C4 lower alcohol, and more preferably a C1-C3 lower alcohol. Typically, the alcohol is ethanol.

[0098] In another preferred embodiment of the present invention, the Chinese herbal medicine extract is prepared by the following method, comprising the steps of:

[0099] (1) extracting the Chinese medicine composition with an extraction solvent selected from the group consisting of water, alcohol or alcohol-water solution to obtain an extract;

[0100] (2) The extract is purified by a macroporous adsorption resin column to obtain an extract.

[0101] In another preferred embodiment, in step (1), the alcohol content in the alcohol aqueous solution is 3.0-98% (v / v), preferably 40-98% (v / v), more preferably 50-90% (v / v), and most preferably 60-80% (v / v).

[0102] In another preferred embodiment, the step (2) further comprises the steps of:

[0103] (2a) extracting the Chinese medicine composition with an extraction solvent selected from the group consisting of water, alcohol or alcohol-water solution to obtain an extract;

[0104] The extract described in (2b) is purified by a macroporous adsorption resin column to obtain an extract.

[0105] In another preferred embodiment, in step (2a), the alcohol content in the alcohol aqueous solution is 10-90% (v / v), preferably 20-80% (v / v), more preferably 30-70% (v / v), and most preferably 40-60% (v / v).

[0106] In another preferred embodiment, in step (2b), during the macroporous adsorption resin column purification process, the eluent is an alcohol-water solution.

[0107] In another preferred embodiment, in the step (2b), the alcohol content in the alcohol aqueous solution in the eluent is 40-98% (v / v).

[0108] In another preferred embodiment, the macroporous adsorption resin column is a styrene-type weakly polar macroporous adsorption resin column.

[0109] In another preferred embodiment, the styrene-type weak polar macroporous adsorption resin column is an AB-8 styrene-type weak polar macroporous adsorption resin column.

[0110] In another preferred embodiment, in the step (2b), the column diameter to height ratio of the macroporous adsorption resin column is 1:2-3.5.

[0111] In another preferred embodiment, the volume of the resin column is 0.8-2L.

[0112] In another preferred embodiment, during the purification process of the macroporous adsorption resin column, 0.2-1.2 times the column volume of water is first used for impurity removal, the water impurity removal eluate is discarded, and then eluted with 2-6 times 40-80% (v / v) C1-C3 lower alcohol aqueous solution and 6-10 times 85-98% (v / v) C1-C3 lower alcohol aqueous solution in sequence, the alcohol water eluate is collected, and concentrated to obtain the extract.

[0113] In another preferred embodiment, after removing the solvent from the alcohol-water eluent, a Chinese medicine extract is obtained.

[0114] In the present invention, it should be understood that the extract includes not only the concentrated solution (such as extract) or active ingredient (such as powder) obtained by extracting the raw medicinal materials after mixing, but also the concentrated solution (such as extract) or active ingredient mixture (including the mixture between concentrated solution and concentrated solution, active ingredient and active ingredient, or between concentrated solution and active ingredient) obtained by extracting a single medicinal material from the raw medicinal materials. The active ingredient of the raw medicinal materials includes a single ingredient or a mixed ingredient.

[0115] Preparation method

[0116] 1. Granules

[0117] The prepared dry extract powder was added with conventional auxiliary materials for granules, mixed and granulated by a wet method, dried and granulated to obtain Shuanghuang Danju Fang granules (each gram of granules contained 4.4 grams of crude drug).

[0118] 2. Capsules

[0119] The prepared dry extract powder is added with conventional capsule auxiliary materials respectively, mixed and granulated by a wet method, dried, granulated, and filled into capsules to obtain Shuanghuang Danju Fang capsules.

[0120] 3. Tablets

[0121] The prepared dry extract powder is added with conventional tablet auxiliary materials respectively, and wet-mixed granulated, dried, granulated, and tableted to obtain Shuanghuangdanju tablets.

[0122] use

[0123] The present invention provides a use of a Chinese medicine composition or an extract thereof for preparing a pharmaceutical composition or preparation, wherein the pharmaceutical composition or preparation is used for (but not limited to): (i) preventing and / or treating inflammation; and / or (ii) preventing and / or treating symptoms caused by inflammation; wherein the inflammation is upper respiratory tract inflammation and / or pneumonia.

[0124] Wherein, the Chinese medicine composition comprises one or more medicinal materials selected from the following group: Astragalus, Boju, Scutellaria and Salvia miltiorrhiza.

[0125] In a preferred embodiment of the present invention, the inflammation is caused by bacterial infection.

[0126] In another preferred embodiment of the present invention, the symptom of inflammation is selected from the group consisting of fever, cough, sputum, inflammation, asthma, or a combination thereof.

[0127] The present invention also provides a use of a Chinese medicine composition or an extract thereof for preparing a pharmaceutical composition or preparation, wherein the pharmaceutical composition or preparation is used for: (a) relieving fever; (b) anti-inflammatory; (c) antitussive; and / or (d) expectorant.

[0128] Pharmaceutical composition

[0129] In a preferred embodiment of the present invention, the raw medicinal materials of Scutellaria baicalensis, Astragalus membranaceus, Boju and / or Salvia miltiorrhiza can be directly added to the composition or added to the pharmaceutical composition after being crushed. In addition, those skilled in the art can also directly use the Chinese medicine extract of the present invention for processing to prepare a pharmaceutical composition. In addition, those skilled in the art can extract active ingredients from each raw medicine and mix them into the pharmaceutical composition. In a preferred embodiment of the present invention, the pharmaceutical composition of the present invention is prepared by mixing the raw medicinal material extract with a carrier, and the medicinal material extract can be prepared by mixing the extracts of each raw medicinal material.

[0130] There is no particular limitation on the dosage form of the pharmaceutical composition of the present invention, and it can be any dosage form suitable for mammals. Preferably, the dosage form can include tablets, capsules, granules, pills, powders, oral liquids, buccal tablets, or aerosols; most preferably, tablets, capsules, or granules. From the standpoint of ease of preparation, administration or taking, the preferred composition is a solid composition. Oral administration is preferred.

[0131] The composition of the present invention may be added with various conventional carriers and / or auxiliary materials required for preparing different dosage forms, such as fillers (such as starch, cellulose, dextrin), disintegrants (sodium carboxymethyl starch), lubricants (magnesium stearate), solvents (purified water), cosolvents (ethanol), and coating materials. Conventional methods for preparing traditional Chinese medicine preparations may be used to prepare any commonly used dosage form, such as tablets, capsules, granules, capsules, pills, and powders.

[0132] As used herein, the term "pharmaceutically acceptable carrier" refers to a substance that is suitable for human and / or animal use without excessive adverse side effects (such as toxicity, irritation and allergic reactions), that is, a substance with a reasonable benefit / risk ratio. Some examples of pharmaceutically acceptable carriers include cellulose and its derivatives (such as methylcellulose, ethylcellulose, hydroxypropylmethylcellulose, sodium carboxymethylcellulose, etc.), gelatin, talc, solid lubricants (such as stearic acid, magnesium stearate), calcium sulfate, vegetable oils (such as soybean oil, sesame oil, peanut oil, olive oil, etc.), polyols (such as propylene glycol, glycerol, mannitol, sorbitol, etc.), emulsifiers (such as Tween), wetting agents (such as sodium lauryl sulfate), buffers, chelating agents, thickeners, pH adjusters, transdermal enhancers, colorants, flavoring agents, stabilizers, antioxidants, preservatives, antibacterial agents, pyrogen-free water, etc.

[0133] Dosage and treatment methods

[0134] The Chinese medicine composition and extract thereof of the present invention can be used to prepare a pharmaceutical composition or preparation for preventing and / or treating inflammation, and / or preventing and / or treating symptoms caused by inflammation. The pharmaceutical composition or preparation of the present invention may also contain other optional medicinal materials or extracts thereof or other drugs effective for treating and / or preventing bronchitis and / or symptoms caused by bronchitis.

[0135] The pharmaceutical composition or preparation is matched with the mode of administration. When using the pharmaceutical composition or preparation, a safe and effective amount of the drug is applied to the desired object (such as a human or non-human mammal). Usually, the pharmaceutical composition or preparation of the present invention is administered at a dose of 0.001-20g / kg of animal body weight per day, preferably 1-4 times a day in separate doses, or in a sustained-release form. For most mammals, the total daily dose is 0.05-600g. Of course, the specific dose will also vary with the mode of administration, dosage form and severity of the disease being treated, and the route of administration, which are all within the skill of a skilled physician. Administration can be carried out by conventional routes, including (but not limited to): oral, intramuscular, dermal, or topical administration. Oral administration is preferred.

[0136] The present invention also provides a method for preventing and / or treating pneumonia, and / or preventing and / or treating symptoms caused by pneumonia, by administering the Chinese medicine composition and / or the Chinese medicine extract of the present invention to a subject in need thereof.

[0137] In another preferred embodiment, the subject is a human or non-human mammal (eg, dog, pig, cat, monkey, sheep, horse, cow, etc.).

[0138] The main advantages of the present invention include:

[0139] (1) The Chinese medicine composition and extract thereof of the present invention can effectively inhibit Staphylococcus aureus, Klebsiella pneumoniae and Pseudomonas aeruginosa.

[0140] (2) The Chinese medicine composition and extract thereof of the present invention can effectively treat upper respiratory tract inflammation and pneumonia caused by bacterial infection.

[0141] 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 based on conventional conditions or the conditions recommended by the manufacturer. Unless otherwise stated, percentages and parts are calculated by weight.

[0142] Example 1. Preparation method of Chinese herbal medicine extract

[0143] Take Astragalus (180g) and add 8 times the amount of 70% ethanol, heat and reflux to extract twice, each time for 1.5 hours, filter, combine the filtrate and concentrate to an extract with a relative density of 1.05-1.20 (50-60°C), dry under reduced pressure (-0.07--0.1MPa, ≤60°C), crush, and pass through a 60-mesh sieve to obtain dry extract powder A (59.41g).

[0144] Take 240g of Radix Scutellariae, 120g of Radix Salviae Miltiorrhizae and 120g of Radix Botrytis Cinnamomi, add 10 times the amount of 50% ethanol, heat and reflux to extract twice, each time for 2 hours, filter, recover ethanol by decompression, and concentrate to a concentrated solution with a relative density of 1.02-1.12 (50-60°C), dilute the concentrated solution with purified water to form a dispersion (containing 0.05kg / L of crude drug), let it stand (add 95% ethanol to the precipitate so that the alcohol content is greater than or equal to 80%, mix well, filter, and collect the filtrate as a spare filtrate), take the supernatant of the dispersion and load it on a styrene-type weak polar macroporous adsorption resin column (AB-8 type), the resin column diameter is 200ml / L, and the filtrate is 100ml / L. The height ratio is 1:2.7, and the volume BV is 1440mL. After loading, 0.5 times BV of purified water is used for elution and impurity removal, and the water-removed impurity eluate is discarded; after the water washing and impurity removal is completed, 4 times BV of 60% ethanol is used for elution, and the eluate is collected. After the elution is completed, the spare filtrate and 7 times BV of 95% ethanol are used for elution, and the eluate is continuously collected until the elution is completed; the eluate is decompressed to recover ethanol and combined to concentrate to an extract with a relative density of 1.05-1.20 (50-60°C), and the extract is dried under reduced pressure (-0.07--0.1MPa, ≤60°C), crushed, and passed through a 60-mesh sieve to obtain dry extract powder B (86.20g). Take dry extract powder A and B and mix them to obtain Chinese medicine extract dry extract powder C (145.61g, each gram of dry extract powder C is equivalent to 4.54 grams of crude drug).

[0145] Example 2. Quality Control Method

[0146] Determination method of baicalin, wogonin, astragaloside IV, astragalus polysaccharide, tanshinone ⅡA, cryptotanshinone, luteolin and quercetin in Shuanghuangdanju prescription extract:

[0147] The HPLC-PDA method was used to simultaneously determine the six main active ingredients (such as baicalin, wogonin, tanshinone ⅡA, cryptotanshinone, luteolin, and quercetin) in Shuanghuangdanju prescription. Figure 1 A and Figure 1 B), HPLC-ELSD method and phenol-sulfuric acid method were used to detect the contents of astragaloside IV and astragaloside polysaccharide in Shuanghuangdanju prescription respectively. Figure 2 A and Figure 2 B. A method for determining the content of effective index components in Shuanghuangdanjufang extract was established for quality control of Shuanghuangdanjufang extract.

[0148] 2.1 Instruments and reagents

[0149] 2.1.1 Instruments

[0150] The instruments used in the experiment are shown in Table 1.

[0151] Table 1: Instruments

[0152]

[0153] 2.1.2 The drugs used in the drug trial are shown in Table 2.

[0154] Table 2: Test drugs

[0155]

[0156]

[0157] 2.2 Methods

[0158] 2.2.1 Determination of flavonoids and quinones content

[0159] 2.2.1.1 Preparation of test solution

[0160] Take 0.1g of Shuanghuangdanju prescription dry extract powder C, put it in a 25mL brown volumetric flask, add 20mL of 75% methanol, ultrasonically treat for 20 minutes (power 250kw, frequency 50kHz), cool to room temperature, add 75% methanol to the scale, shake well, and pass through a 0.45μm microporous filter membrane to obtain.

[0161] 2.2.1.2 Preparation of mixed reference solution

[0162] Take appropriate amount of baicalin, wogonin, tanshinone ⅡA, cryptotanshinone, luteolin, and quercetin reference substances, place them in a 25mL volumetric flask, add methanol to dissolve and dilute to the scale to obtain the reference substance stock solution, take appropriate amount of each stock solution in a 25mL volumetric flask, make up to volume with methanol so that each 1mL contains 26.12, 11.58, 26.56, 2.94, 3.18, and 3.37μg of baicalin, wogonin, quercetin, luteolin, cryptotanshinone, and tanshinone ⅡA, respectively.

[0163] 2.2.1.3 Chromatographic conditions

[0164] C18 chromatographic column; mobile phase: A: methanol, B: 0.05% phosphoric acid; flow rate: 0.8 mL / min; column temperature: 30°C; detection wavelength: 270 nm, 360 nm, as shown in Table 3.

[0165] Table 3: Chromatographic conditions

[0166]

[0167] 2.2.1.4 Determination method

[0168] 10 μl of the test solution and the mixed reference solution were respectively filtered through a 0.45 μm microporous filter membrane and injected into a liquid chromatograph for detection using the above conditions.

[0169] The dry extract powder C of the present invention contains baicalin, quercetin, luteolin, wogonin, cryptotanshinone and tanshinone ⅡA in an amount of not less than 3.6 mg, 1.80 mg, 0.40 mg, 1.28 mg, 0.48 mg and 0.49 mg per gram.

[0170] 2.2.1.5 Test results

[0171] The contents of baicalin, quercetin, luteolin, wogonin, cryptotanshinone and tanshinone ⅡA in dry extract powder C were 0.514%, 0.261%, 0.056%, 0.183%, 0.068% and 0.070%, respectively.

[0172] 2.2.2 Determination of Astragaloside IV

[0173] 2.2.2.1 Preparation of test solution

[0174] Take 4g of dry extract powder C, weigh accurately, add 50mL of methanol, heat and reflux for 1h, cool, weigh, make up the weight with methanol, shake well, filter, evaporate the filtrate to dryness, add 10mL of water to the residue, dissolve it with slight heat, extract with saturated n-butanol solution with water, 40mL each time, for a total of 4 times. Combine the n-butanol solution, wash thoroughly with 40mL of ammonia test solution each time, wash twice in total, discard the ammonia test solution, take the n-butanol solution, evaporate to dryness, dissolve the residue with methanol and transfer it to a 2mL volumetric flask, add methanol to volume, shake well, and obtain.

[0175] 2.2.2.2 Preparation of reference solution

[0176] Accurately weigh 20 mg of astragaloside IV reference substance into a 50 mL volumetric flask, dilute to volume with methanol to make a solution containing 0.4 mg of astragaloside IV per 1 mL.

[0177] 2.2.2.3 Chromatographic conditions

[0178] C18 chromatographic column; evaporative light scattering detector detection; mobile phase: acetonitrile-water (36:64); flow rate:

[0179] 1.2mL / min; column temperature: 35℃; injection volume: 10μl; drift tube temperature: 105℃; nebulizer temperature: 90℃, carrier gas flow rate: 2.7L / min.

[0180] 2.2.2.4 Determination method

[0181] The test solution and the reference solution were respectively aspirated through a 0.45 μm microporous filter membrane, injected into a liquid chromatograph, and tested using the above conditions.

[0182] The dry extract powder C of the present invention contains no less than 0.8 mg of astragaloside IV per gram.

[0183] 2.2.2.5 Test results

[0184] After testing, the content of astragaloside IV in the dry extract powder C was 0.086%.

[0185] 2.2.3 Astragalus polysaccharide content determination method

[0186] 2.2.3.1 Preparation of reference solution

[0187] Accurately weigh 10 mg of D-anhydrous glucose reference substance dried to constant weight at 105°C, place in a 50 mL volumetric flask, and dilute to the mark to obtain a 0.2 mg / mL reference substance solution.

[0188] 2.2.3.2 Preparation of standard curve

[0189] Accurately measure 0mL, 0.1mL, 0.2mL, 0.3mL, 0.4mL, and 0.5mL of the reference solution, place in a stoppered glass test tube, add distilled water to 2.0mL, add 1.0mL of 5% phenol solution to each test tube, mix well, quickly add 5mL of concentrated sulfuric acid solution, mix well, place in an 80℃ water bath for 30 minutes, take out and place at room temperature for 30 minutes. Under the condition of wavelength 490nm, measure its absorbance value, use glucose content as the horizontal axis and absorbance value as the vertical axis, and draw a standard curve (such as Figure 3 ).

[0190] 2.2.3.3 Preparation of test solution

[0191] Accurately weigh 2.0 g of dry extract powder, add 25 mL of water to dissolve by ultrasonication, centrifuge, take 1 mL of supernatant, add 5 mL of anhydrous ethanol to make the alcohol content about 80%, shake well, centrifuge, take the precipitate, wash the precipitate with 5 mL of anhydrous ethanol, centrifuge, take the precipitate, add water to dissolve in a 25 mL volumetric flask, and obtain.

[0192] 2.2.3.4 Sample determination

[0193] Pipette 0.8 mL of the test solution into a stoppered test tube and measure the absorbance at 490 nm according to the UV-visible spectrophotometry (General Rules 0401 of Part IV of the 2020 edition of the Chinese Pharmacopoeia) using phenol-sulfuric acid solution as the blank according to the treatment method of the reference solution in "2.2.3.2".

[0194] The dry extract powder C of the present invention contains no less than 19 mg of astragalus polysaccharide per gram.

[0195] 2.2.3.5 Test results

[0196] According to detection, the content of astragalus polysaccharide in the dry extract powder C of the present invention is 2.81%.

[0197] Comparative Example 1. Comparative study of index components of water extraction process

[0198] Preparation of samples for water extraction process

[0199] According to the weight ratio of Scutellaria baicalensis: Astragalus membranaceus: Salvia miltiorrhiza: Boju = 4:3:2:2, take the four medicinal materials (132 grams) of Shuanghuang Danju recipe, add 10 times the amount of water and boil twice, each time for 2 hours, filter, and concentrate the filtrate to an extract with a relative density of 1.10-1.30 (50-60°C), dry under reduced pressure (-0.07-0.1MPa, ≤60°C), crush, and pass through a 60-mesh sieve to obtain 54.91g of dry extract powder (each gram of dry extract powder is equivalent to 2.40g of crude drug).

[0200] Refining process sample preparation

[0201] The four medicinal materials (660 g) of Shuanghuang Danju prescription were taken in proportion, and referring to the preparation method in Example 1, 145.61 g of sample was obtained (the weight of dry extract powder C, each gram of dry extract powder C is equivalent to 4.54 g of crude drug).

[0202] Detection Methods

[0203] Take water extraction process samples and refined process samples and measure them according to the method under “2.2.1.3 Chromatographic conditions”. The test results are shown in Table 4.

[0204] Table 4: Test results

[0205]

[0206]

[0207] Result analysis:

[0208] According to the above results, through the refining process, the yield of dry extract powder was reduced from 41.621% to 22.034%, and some solid particles, proteins and other macromolecules in the water extract were removed; through the refining process, the content of the index components of Shuanghuang Danju prescription was significantly improved compared with the water extraction process, and the extraction effect of cryptotanshinone and tanshinone ⅡA, which have strong antibacterial ability and are difficult to dissolve in water, was better.

[0209] In summary, the extraction process of Shuanghuangdanju Fang was determined to be a refining process.

[0210] Example 3. Pharmacological studies

[0211] 3.1 Anti-inflammatory experiments

[0212] Giving mice a 900 mg / kg dose of Shuanghuangdanjufang granule suspension for three consecutive days significantly inhibited xylene-induced ear swelling in mice.

[0213] 3.1.1 Experimental Materials

[0214] Pharmaceutical reagents: Shuanghuang Danjufang granules, provided by Shanghai Lvgu Life Park Pharmaceutical Co., Ltd.; normal saline, produced by Henan Kelun Pharmaceutical Co., Ltd., batch number B17041907; xylene, produced by Tianjin Tianli Chemical Reagent Co., Ltd., batch number 20140108.

[0215] Experimental animals: Kunming mice, male, SPF grade, weighing 18-21 g, certificate numbers 37009200006983 and 37009200007424, provided by Jinan Pengyue Experimental Animal Breeding Co., Ltd., license number: SCXK(Lu)20140007; experimental animal use license SYXK(Yu)2015-0005.

[0216] Experimental instruments: puncher, produced by Beijing Pinggu Beizhangdai Hardware Factory; precision balance, produced by Shanghai Minqiao Precision Scientific Instrument Co., Ltd. (model JA1103N).

[0217] 3.1.2 Experimental methods

[0218] Experimental method: 24 male mice weighing 18-21g were randomly divided into 2 groups. Shuanghuangdanjufang granule suspension (900mg / kg, 90mg / mL, 30 times the clinical dosage) and the same volume of normal saline (0.1mL / 10g) were respectively administered orally. The drug was administered once a day for 3 consecutive days. One hour after the last administration, 0.04mL of xylene was applied to the right ear of each mouse (0.02mL was applied to both the front and back). 4 hours after the administration of xylene, the mice were killed by dislocating the cervical vertebrae, the ears were cut off and aligned, and the ear pieces of both ears were punched with a puncher. The ears were quickly weighed with an electronic balance, and the swelling degree was calculated. Swelling degree = right ear weight - left ear weight.

[0219] Statistical methods: SPSS 19.0 for Windows was used for statistical analysis of data, and the measured data were expressed as mean ± standard deviation. The groups were compared using one-way analysis of variance, and the least significant difference (LSD) method was used for equal variance test, and the Games-Howell method was used for unequal variance test.

[0220] 3.1.3 Experimental results

[0221] As shown in Table 5, compared with the normal saline group, the Shuanghuangdanjufang granule group could significantly inhibit the xylene-induced ear swelling of mice (P<0.01).

[0222] Table 5: Effect of Shuanghuangdanju prescription on xylene-induced ear swelling in mice ( n=12)

[0223] Group Dosage (mg / kg) Swelling degree (mg) Normal saline group - 9.02±0.72 Shuanghuangdanjufang granules group 900 4.37±0.52**

[0224] Note: P<0.05, **P<0.01 compared with the normal saline group

[0225] 3.1.4 Conclusion

[0226] Giving mice a 900 mg / kg dose of Shuanghuang Danju Fang granule suspension for three consecutive days can significantly reduce the swelling of the mouse ear shell caused by xylene, suggesting that Shuanghuang Danju Fang granules can inhibit acute inflammation caused by xylene.

[0227] 3.2 Antibacterial experiment

[0228] Shuanghuangdanjufang granules have inhibitory effects on Staphylococcus aureus, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

[0229] 3.2.1 Experimental Materials

[0230] Reagent drugs: Shuanghuangdanjufang granules, Shanghai Lvgu Life Park Pharmaceutical Co., Ltd.; Amoxicillin capsules (0.5g for adults, once every 6-8 hours, and the daily dose does not exceed 4g), Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd., batch number 4160026; Shuanghuanglian capsules (4 capsules at a time, 3 times a day), Guangdong Huizhou Traditional Chinese Medicine Factory Co., Ltd., batch number 20180123; Nutrient agar, produced by Beijing Solebaugh Technology Co., Ltd., batch number 507A031; Nutrient broth, produced by Beijing Solebaugh Technology Co., Ltd., batch number 20180124; McFarland turbidimeter tube, produced by Beijing Solebaugh Technology Co., Ltd., batch number 20180123; Medical ethanol, produced by Xinxiang Sanwei Disinfection Preparation Co., Ltd., batch number 20140105; Normal saline, produced by Henan Kelun Pharmaceutical Co., Ltd., batch number B17041907.

[0231] Experimental strains: Staphylococcus aureus [CMCC (B) 26112], batch number 10; Klebsiella pneumoniae [CMCC (B) 46117], batch number 5a; Pseudomonas aeruginosa [CMCC (B) 10104], batch number 2a22-2. The strains used in this experiment were provided by the China Medical Bacteria Collection Management Center of the China Food and Drug Inspection Institutes.

[0232] Experimental equipment: precision balance, Shanghai Minqiao Precision Scientific Instrument Co., Ltd., model JA1103N; adjustable pipette, produced by Shanghai Leibo Analytical Instrument Co., Ltd.; biochemical incubator, produced by Beijing Kewei Yongxing Instrument Co., Ltd. (model SPX-80); clean bench, produced by Suzhou Su Clean Equipment Co., Ltd. (model Sw-LJ-2F); vertical pressure steam sterilizer, produced by Shanghai Shen'an Medical Equipment Factory (model LDZX-50FBS).

[0233] 3.2.2 Experimental methods

[0234] Preparation of bacterial solution: Culture each experimental strain in sterile nutrient broth at a constant temperature of 35℃-37℃ for 24 hours. After the activity is restored, dilute it with physiological saline under sterile conditions to a concentration of 1.0McF for later use. Prepare it for immediate use.

[0235] MIC range determination: Use sterile nutrient broth to dilute Shuanghuang Danju Fang granules into different concentrations of drug solution, take 2.4mL of drug solution, add 100μl of bacterial solution, mix well, make 10 copies of each bacteria and each concentration in parallel, so that the final concentration of the test drug in each tube of mixed solution is shown in Table 6, during the constant temperature culture at 35℃-37℃, mix once every 6h; after 24h, extract 30μl of each tube of liquid after mixing, spread it on sterile nutrient agar, and culture it at 35℃-37℃ for 24h, observe the growth of colonies, and determine the MIC range. The concentration of the tested drug is shown in Table 6.

[0236] Table 6: Test drug concentrations

[0237]

[0238]

[0239] MBC determination: Based on the MIC range, take 30 μl of the mixed solution from the tubes corresponding to the nutrient agar without colony growth and spread it on the sterile nutrient agar. Incubate at 35℃-37℃ for 18 hours, observe the colony growth, and determine the MBC. The lowest concentration corresponding to the sterile nutrient agar with no colony growth or less than 5 colony counts is the MBC of the strain under the experimental conditions. The experimental results are shown in Table 7.

[0240] 3.2.3 Experimental results

[0241] The in vitro MIC ranges and MBC results of each drug against three common bacteria that cause upper respiratory tract infections are shown in Table 7.

[0242] Table 7: In vitro MIC range and MBC of each drug against three upper respiratory tract infection bacteria

[0243]

[0244] Each test strain grew well in the bacterial solution + nutrient broth control tube, and no colonies grew on the corresponding nutrient agar of the saline + nutrient broth control group, indicating that the experimental conditions were sterile. As shown in Table 7, Shuanghuang Danju Fang granules have certain inhibitory and killing effects on three common upper respiratory tract infection bacteria: Staphylococcus aureus, Klebsiella pneumoniae, and Pseudomonas aeruginosa. The inhibitory and killing effects on Staphylococcus aureus are stronger, with a MIC range of 8.00-10.00 mg / mL and an MBC of 10.00 mg / mL.

[0245] 3.2.4 Conclusion

[0246] Shuanghuangdanjufang granules have certain inhibitory and killing effects on Staphylococcus aureus, Klebsiella pneumoniae, and Pseudomonas aeruginosa. The MIC for Staphylococcus aureus is 8.00-10.00 mg / mL, and the MBC is 10.00 mg / mL; the MIC for Klebsiella pneumoniae is 20.01-25.02 mg / mL, and the MBC is 25.02 mg / mL; the MIC for Pseudomonas aeruginosa is 54.98-60.00 mg / mL, and the MBC is 60.00 mg / mL. The inhibitory and killing effects on Staphylococcus aureus are the strongest.

[0247] In summary, the extracts of Scutellaria baicalensis, Astragalus membranaceus, Boju and Salvia miltiorrhiza prepared by the present invention, i.e., Shuanghuang Danju prescription, have a good inhibitory effect on Staphylococcus aureus, Klebsiella pneumoniae and Pseudomonas aeruginosa, and can effectively treat upper respiratory tract inflammation and pneumonia infected by Staphylococcus aureus, Klebsiella pneumoniae or Pseudomonas aeruginosa, thereby indicating that the Chinese medicine composition and / or Chinese medicine extract of the present invention has an excellent therapeutic effect on upper respiratory tract inflammation and pneumonia and their symptoms.

[0248] All documents mentioned in the present invention are cited as references in this application, just as each document is cited as reference individually. In addition, it should be understood that after reading the above teachings of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the claims attached to this application.

Claims

1. A Chinese medicine composition, characterized in that: The Chinese medicine composition comprises: Salvia miltiorrhiza is 300-500 parts by weight; Boju is 300-500 parts by weight; 500-700 parts by weight of Astragalus; and / or The amount of Scutellaria baicalensis is 700-900 parts by weight.

2. A Chinese medicine extract, characterized in that: The Chinese medicine extract is extracted from the Chinese medicine composition as claimed in claim 1.

3. The Chinese medicine extract according to claim 2, characterized in that The Chinese medicine extract contains ingredients selected from the following group: baicalein, wogonin, quercetin, luteolin, cryptotanshinone, tanshinone ⅡA, astragaloside IV, astragaloside polysaccharide, or a combination thereof.

4. The Chinese medicine extract according to claim 2, characterized in that The Chinese herbal medicine extract contains ingredients selected from the following group: The content of baicalein is 0.4-0.6wt%, based on the total weight of the Chinese medicine extract; The content of quercetin is 0.16-0.36wt%, based on the total weight of the Chinese medicine extract; The content of luteolin is 0.045-0.065wt%, based on the total weight of the traditional Chinese medicine extract; The content of wogonin is 0.1-0.3wt%, based on the total weight of the Chinese medicine extract; The content of cryptotanshinone is 0.06-0.08wt%, based on the total weight of the traditional Chinese medicine extract; The content of tanshinone ⅡA is 0.06-0.08wt%, based on the total weight of the traditional Chinese medicine extract; The content of astragaloside IV is 0.08-0.1wt%, based on the total weight of the traditional Chinese medicine extract; The content of astragalus polysaccharide is 2.6-3wt%, based on the total weight of the traditional Chinese medicine extract.

5. A method for preparing the Chinese medicine extract according to claims 2-4, characterized in that: Includes steps: (S1) extracting Astragalus membranaceus using a first extraction solvent to obtain a dry extract powder A; (S2) extracting Scutellaria baicalensis, Salvia miltiorrhiza, and Bohemia radix with a second extraction solvent to obtain a dry extract powder B; (S3) The dry extract powder A and the dry extract powder B are mixed and granulated to obtain the Chinese herbal medicine extract.

6. A use of the Chinese medicine composition according to claim 1 and / or the Chinese medicine extract according to claim 2, characterized in that: Used for preparing a pharmaceutical composition or preparation, wherein the pharmaceutical composition or preparation is used for: (i) preventing and / or treating inflammation; and / or (ii) preventing and / or treating symptoms caused by inflammation; The inflammation is upper respiratory tract inflammation and / or pneumonia.

7. The use according to claim 6, characterized in that The inflammation is caused by bacterial infection.

8. The use according to claim 6, characterized in that The bacteria is selected from the group consisting of Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, or a combination thereof.

9. The use according to claim 6, characterized in that The symptom is selected from the group consisting of fever, cough, sputum, inflammation, wheezing, or a combination thereof.

10. A pharmaceutical composition or preparation for preventing and / or treating inflammation, and / or preventing and / or treating symptoms caused by inflammation, characterized in that: It comprises the Chinese medicine composition as claimed in claim 1 or the drug extract as claimed in claim 2; and a pharmaceutically acceptable carrier; wherein the inflammation is upper respiratory tract inflammation and / or pneumonia.

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