Traditional Chinese medicine composition for nourishing yin, moistening lung and clearing throat as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition which comprises the following raw materials in parts by weight: 1-5 parts of a traditional Chinese medicine extract A, 0.5-2.5 parts of a traditional Chinese medicine extract B, 5-25 parts of a traditional Chinese medicine extract C and 0.4-2 parts of a traditional Chinese medicine extract D, the traditional Chinese medicine extract A is prepared from flos farfarae, fructus canarii, dementholized peppermint oil and beta-cyclodextrin; the raw material of the traditional Chinese medicine extract B comprises moutan bark; the traditional Chinese medicine extract C is prepared from the following raw materials: radix scrophulariae, radix stemonae (prepared), radix asparagi, radix ophiopogonis, radix rehmanniae and radix isatidis; the raw materials of the traditional Chinese medicine extract D comprise oroxylum indicum and cicada slough. Through the components and a specific process, the invention provides the pharmaceutical composition with the effects of nourishing yin, moistening lung, relieving cough, relieving itching and clearing throat, which is reasonable in formula, clear in medicinal composition, few in impurities, quick in effect, long in medicinal effect time, small in dosage and clear in medicinal effect material basis, and has the effects of nourishing yin, moistening lung, relieving cough, relieving itching and clearing throat.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for nourishing yin, moistening the lungs and clearing the throat, as well as a preparation method and application thereof. Background Art

[0002] Pharyngitis is a common throat disease, which can be acute or chronic. It is primarily caused by bacterial or viral infections and is often accompanied by symptoms such as dry throat, itchy throat, and an irritating cough, severely impacting patients' quality of life. Currently, there are a variety of pharyngitis treatments on the market, among which pharyngitis tablets have attracted much attention due to their ease of administration and proven efficacy.

[0003] Pharyngitis tablets are a traditional Chinese medicine compound used to relieve and treat inflammation and related symptoms in the throat. They are composed of Scrophularia, Stemona (processed), Asparagus, Paeonia, Ophiopogon, Coltsfoot (processed), Rehmannia, Oroxylum, Isatis, Cicadae, Cicadae, and Peppermint oil.

[0004] Most of the existing technologies are based on the preparation process of mixing and drying the traditional water-extracted extract with the medicinal material powder. The formulation is mainly based on the administration route, excipients, new dosage forms and other aspects that are different from the traditional oral administration. The drug ratios of each party are different, the extract has not been purified and enriched, the extract contains many chemical components, the dosage is large, and the site of efficacy is unclear.

[0005] Therefore, it is very necessary to provide a pharmaceutical composition with the functions of nourishing yin, moistening lungs and clearing throat, which has a reasonable formula, a clear site of efficacy, few impurities and a small dosage. Summary of the Invention

[0006] In view of this, the technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition for nourishing yin, moistening lungs and clearing throat. The traditional Chinese medicine composition provided by the present invention has the effects of nourishing yin, clearing lungs, clearing heat and detoxifying.

[0007] The present invention provides a pharmaceutical composition with reasonable formula, clear medicinal ingredients, few impurities, rapid onset, long medicinal effect, small dosage, clear medicinal material basis and the functions of nourishing yin and moistening lungs, relieving cough and itching, and clearing throat.

[0008] The yin-nourishing, lung-moistening and throat-clearing functions of the present invention refer to the effects of relieving cough, resolving phlegm, relieving fever, resisting inflammation, relieving pain, moistening the throat, and relieving throat swelling.

[0009] In the present invention, Scrophulariaceae is the main ingredient, clearing away heat and nourishing yin, removing toxins and dispersing stagnation; Radix Rehmanniae, Radix Ophiopogonis, Radix Asparagopsis, Radix Isatidis, Radix Isatidis, and Cortex Moutan are the ministerial ingredients, nourishing yin and promoting fluid production, clearing the throat, moistening the lungs and relieving cough, cooling blood and relieving sore throat; Radix Stemonae, processed Radix Ophiopogonis, Oroxylum, and Periostracum Cicadae are the adjuvant ingredients, moistening the lungs and relieving cough, lowering qi and resolving phlegm, and clearing the throat; and peppermint oil is the guiding ingredient, dispersing wind and heat, and clearing the head and eyes. The combination of these ingredients achieves the effects of nourishing yin and moistening the lungs, clearing heat and removing toxins, and clearing the throat. The present invention does not change the original formula of the Pharyngitis Tablet, which has the main ingredient, the minister ingredient, the assistant ingredient, and the guiding ingredient.

[0010] The present invention provides a traditional Chinese medicine composition comprising the following raw materials in parts by weight:

[0011] 1-5 parts of Chinese herbal medicine extract A, 0.5-2.5 parts of Chinese herbal medicine extract B, 5-25 parts of Chinese herbal medicine extract C, and 0.4-2 parts of Chinese herbal medicine extract D;

[0012] The raw materials of the Chinese herbal medicine extract A include coltsfoot flower, green fruit, mint oil and β-cyclodextrin;

[0013] The raw materials of the Chinese medicine extract B include peony bark;

[0014] The raw materials of the Chinese medicine extract C include Scrophularia ningpoensis, Stemona radix (processed), Asparagus cochinchinensis, Ophiopogon japonicus, Rehmannia glutinosa and Isatis indigotica;

[0015] The raw materials of the Chinese medicine extract D include Oroxylum indicum and Cicada slough.

[0016] According to the present invention, the Chinese medicine composition for nourishing yin, moistening lungs and clearing throat comprises the following raw materials in parts by weight:

[0017] 2-4 parts of Chinese herbal medicine extract A, 1-2 parts of Chinese herbal medicine extract B, 10-20 parts of Chinese herbal medicine extract C, and 0.8-1.8 parts of Chinese herbal medicine extract D.

[0018] According to the present invention, the Chinese medicine composition for nourishing yin, moistening lungs and clearing throat comprises the following raw materials in parts by weight:

[0019] 3 parts of Chinese herbal medicine extract A, 1.5 parts of Chinese herbal medicine extract B, 15 parts of Chinese herbal medicine extract C, and 1.2 parts of Chinese herbal medicine extract D.

[0020] In some specific embodiments, the traditional Chinese medicine composition for nourishing yin, moistening lungs and clearing throat comprises the following raw materials in parts by weight:

[0021] 1 part of Chinese herbal medicine extract A, 0.5 part of Chinese herbal medicine extract B, 5 parts of Chinese herbal medicine extract C, and 0.4 part of Chinese herbal medicine extract D.

[0022] In some specific embodiments, the traditional Chinese medicine composition for nourishing yin, moistening lungs and clearing throat comprises the following raw materials in parts by weight:

[0023] 3 parts of Chinese herbal medicine extract A, 1.5 parts of Chinese herbal medicine extract B, 15 parts of Chinese herbal medicine extract C, and 1.2 parts of Chinese herbal medicine extract D.

[0024] In some specific embodiments, the traditional Chinese medicine composition for nourishing yin, moistening lungs and clearing throat comprises the following raw materials in parts by weight:

[0025] 5 parts of Chinese herbal medicine extract A, 2.5 parts of Chinese herbal medicine extract B, 25 parts of Chinese herbal medicine extract C, and 2 parts of Chinese herbal medicine extract D.

[0026] In the present invention, the preparation method of the Chinese medicine extract A comprises:

[0027] Taking coltsfoot flower and water, mixing and soaking, and then steam distilling and extracting, to obtain coltsfoot flower oil and medicinal residue a;

[0028] The mass ratio of coltsfoot flower to water is 1:(5-7); preferably 1:6; the soaking time is 0.5-1h; preferably 0.5h; the steam distillation extraction time is 5-7h; preferably 6h;

[0029] In some specific embodiments, 10 parts of coltsfoot flower (processed) were taken, 6 times the amount of water was added, soaked for 0.5 hours, heated to maintain a slight boiling point, and steam distilled for 6 hours to collect volatile oil and medicinal residue a;

[0030] The green fruit is crushed, soaked in water, and then steam distilled to obtain green fruit volatile oil and medicinal residue b;

[0031] The mesh size of the green fruit is 24 mesh; the mass ratio of the green fruit to water is 1:(5-7); preferably 1:6; the soaking time is 0.5-1h; preferably 0.5h; the steam distillation extraction time is 5-7h; preferably 6h;

[0032] In some specific embodiments, 10 portions of green fruit were taken, crushed into 24 mesh fine powder, added with 6 times the amount of water, soaked for 0.5 hours, steam distilled for 6 hours, and the volatile oil was collected;

[0033] Peppermint oil, coltsfoot flower oil, green fruit volatile oil, β-cyclodextrin and water are mixed and ground in a colloid mill to obtain an inclusion compound, which is freeze-dried and crushed to obtain the Chinese medicine extract A.

[0034] The mass ratio of the peppermint oil, coltsfoot flower oil, green fruit volatile oil and beta-cyclodextrin is 10:1:1:8.

[0035] The grinding time of the colloid mill is 0.5 h to 1.5 h, preferably 1 h, and the mesh size of the crushing is 60 to 80 mesh.

[0036] In some specific embodiments, 10 parts of peppermint oil are mixed with coltsfoot flower (processed) volatile oil and green fruit volatile oil, 8 times the amount of β-cyclodextrin and 10 times the amount of water are added, the mixture is ground in a colloid mill for 1 hour, filtered, the inclusion complex is freeze-dried, and crushed into a fine powder of 60-80 mesh.

[0037] The present invention creatively adopts volatile oil extraction technology and steam distillation technology to improve the yield of volatile components and ensure the efficacy; and adopts volatile oil inclusion technology to improve the stability of volatile components and ensure the efficacy.

[0038] According to the present invention, the preparation method of the Chinese medicine extract B comprises:

[0039] Crushing the peony bark, extracting it by steam distillation, and obtaining a distillate and a medicinal residue c;

[0040] Add hydrochloric acid to the distillate, let it stand, filter, wash, dry at low temperature, and crush to obtain Chinese medicine extract B;

[0041] The mesh size of the peony bark crushed is preferably 24 mesh; the distillation time is 5 to 6 hours, preferably 6 hours; the concentration of hydrochloric acid is 1 mol / L; the standing time is 24 to 36 hours, specifically 24 hours, 25 hours, 26 hours, 27 hours, 28 hours, 29 hours, 30 hours, 31 hours, 32 hours, 33 hours, 34 hours, 35 hours, 36 hours

[0042] The temperature for low-temperature drying is 35-40°C, specifically 35°C, 36°C, 37°C, 38°C, 39°C, or 40°C.

[0043] In some specific embodiments, 10 parts of peony bark are taken and crushed into 24 mesh fine powder. Steam is introduced into the bottom of the medicinal material for steam distillation. The distillation is stopped when the effluent is no longer white. The distillation time is 6 hours. 1 mol / L hydrochloric acid solution is added to the collected distillate, and the mixture is allowed to stand for 24-36 hours. The mixture is filtered, the crystals are washed with water, dried at a low temperature of 35-40°C, and crushed into 80-100 mesh fine powder; thus, a Chinese medicine extract B for nourishing yin, moistening the lungs, and clearing the throat is obtained.

[0044] According to the present invention, the preparation method of the Chinese medicine extract C comprises:

[0045] The medicinal residues a, b, c, Scrophularia ningpoensis, Stemona radix (processed), Asparagus cochinchinensis, Ophiopogon japonicus, Rehmannia glutinosa, and Radix Isatidis were mixed with water for extraction through reflux, the decoctions were combined, filtered, and purified by macroporous adsorption resin, the eluate was collected and concentrated to obtain a thick paste; the thick paste was dried under reduced pressure and crushed to obtain Chinese medicine extract C.

[0046] According to the present invention, the mass ratio of Scrophulariaceae, Stemona (processed), Asparagus cochinchinensis, Ophiopogon japonicus, Rehmannia root and Isatis indigotica is 10:10:10:10:10:10;

[0047] In some embodiments, the mass ratio of medicinal residue a, medicinal residue b, medicinal residue c, Scrophularia ningpoensis, Stemona radix (processed), Asparagus cochinchinensis, Radix Ophiopogonis, Radix Rehmanniae and Radix Isatidis is 1:1:10:10:10:10:10:10

[0048] The number of reflux extractions in the present invention is two times; 8 times and 6 times the amount of water are added respectively, and reflux extraction is performed twice, the first time for 3 hours and the second time for 2 hours, and the decoctions are combined and filtered through 300 meshes.

[0049] After filtration, purification is performed by macroporous adsorption resin, and the parameters of the macroporous adsorption resin purification include: the model of the macroporous adsorption resin is D101; the diameter-to-height ratio is 1:5; the sample loading flow rate is 1-2 BV / h; preferably 1.5 BV / h; after loading, the macroporous resin column is rinsed with purified water until the effluent water is colorless, and then eluted with 70% ethanol; the flushing flow rate is 1-2 BV / h; preferably 1.5 BV / h; the elution flow rate of 70% ethanol is 1 BV / h.

[0050] When the eluate is colorless, collect the eluate, recover the ethanol under reduced pressure, concentrate to a thick paste with a relative density of 1.28-1.30 (60-80°C), dry under reduced pressure, and grind.

[0051] The relative density of the thick paste is 1.28-1.30; the temperature of the reduced pressure drying is 60-80°C, specifically 60°C, 61°C, 62°C, 63°C, 64°C, 65°C, 66°C, 67°C, 68°C, 69°C, 70°C, 71°C, 72°C, 73°C, 74°C, 75°C, 76°C, 77°C, 78°C, 79°C, and 80°C.

[0052] The mesh size of the crushed material is 80 to 100 meshes; it can be 80 meshes, 85 meshes, 90 meshes, 95 meshes, or 100 meshes.

[0053] The present invention adopts purification technologies such as macroporous resin adsorption and ethanol extraction to remove water-soluble impurities, reduce the dosage, and achieve precise medication.

[0054] According to the present invention, the preparation method of the Chinese medicine extract D comprises:

[0055] Mix Oroxylum butterfly and Cicada shell with 70% ethanol, extract under reflux, filter, concentrate to a thick paste, dry, and grind to obtain Chinese medicine extract D;

[0056] In the present invention, the mass ratio of the oroxylum butterfly to the cicada slough is 10:10; the relative density of the thick paste is 1.25-1.28; the reflux extraction is performed twice; each reflux extraction lasts 1-2 hours; preferably, the first reflux extraction lasts 2 hours and the second reflux extraction lasts 1 hour. 6 times the amount of 70% ethanol is added to the first reflux extraction and 5 times the amount of 70% ethanol is added to the second reflux extraction.

[0057] The temperature of the reduced pressure drying is 60-80° C.; the mesh size of the pulverization is 80-100 meshes.

[0058] In some specific embodiments, 10 parts of Oroxylum butterfly and 10 parts of Cicada Periostracum were taken, 6 times and 5 times the amount of 70% ethanol were added, and reflux extraction was performed twice, the first time for 2 hours and the second time for 1 hour. The decoctions were combined, filtered through 300 mesh, and ethanol was recovered under reduced pressure. The mixture was concentrated to a thick paste with a relative density of 1.25-1.28 (60-80°C), and dried under reduced pressure at 60-80°C; specifically, at 60°C, 61°C, 62°C, 63°C, 64°C, 65°C, 66°C, 67°C, 68°C, 69°C, 70°C, 71°C, 72°C, 73°C, 74°C, 75°C, 76°C, 77°C, 78°C, 79°C, and 80°C, and pulverized into a fine powder of 80-100 mesh to obtain a Chinese medicine extract D that nourishes yin, moistens the lungs, and clears the throat.

[0059] The present invention provides a method for preparing the traditional Chinese medicine composition for nourishing yin, moistening the lungs and clearing the throat as described in any one of the above technical solutions, comprising the following steps:

[0060] The Chinese herbal medicine extract A, Chinese herbal medicine extract B, Chinese herbal medicine extract C and Chinese herbal medicine extract D are mixed to obtain the product.

[0061] The specific preparation methods of the above-mentioned Chinese herbal extract A, Chinese herbal extract B, Chinese herbal extract C, and Chinese herbal extract D have been clearly described above and will not be repeated here.

[0062] The present invention does not limit the above-mentioned mixing method, and any mixing method well known to those skilled in the art can be used.

[0063] The present invention provides the use of the traditional Chinese medicine composition described in the above technical solution in preparing a medicine for nourishing yin, moistening the lungs and clearing the throat.

[0064] The Chinese medicine composition provided by the present invention has the effects of relieving cough, eliminating phlegm, relieving fever and anti-inflammatory;

[0065] The traditional Chinese medicine composition provided by the present invention can promote the secretion of phenol red in the respiratory tract, reduce body temperature, reduce serum PGE2 content and serum PGE2 content; the traditional Chinese medicine composition provided by the present invention can reduce ear swelling and improve the ear swelling inhibition rate.

[0066] The present invention provides a medicine for nourishing yin, moistening lungs and clearing throat, comprising the Chinese medicine composition with detoxification function described in any one of the above technical solutions.

[0067] The present invention also includes auxiliary materials or ingredients commonly used in the pharmaceutical field.

[0068] The dosage forms of the present invention include, but are not limited to, one or more of granules, decoctions, powders, oral solutions, tablets, pills, pastes or capsules.

[0069] The medicine of the present invention further comprises excipients; the excipients include fillers, adhesives, wetting agents or flavoring agents;

[0070] The filler includes one or more of starch, dextrin, microcrystalline cellulose, mannitol, sucrose or lactose; the binder includes one or more of povidone K30 or syrup; the wetting agent includes ethanol; and the flavoring agent includes one or more of essence, stevia or aspartame.

[0071] The present invention provides a traditional Chinese medicine composition comprising the following raw materials in parts by weight: 1 to 5 parts of a traditional Chinese medicine extract A, 0.5 to 2.5 parts of a traditional Chinese medicine extract B, 5 to 25 parts of a traditional Chinese medicine extract C, and 0.4 to 2 parts of a traditional Chinese medicine extract D; the raw materials of the traditional Chinese medicine extract A include coltsfoot flower, green fruit, mentha oil, and β-cyclodextrin; the raw materials of the traditional Chinese medicine extract B include peony bark; the raw materials of the traditional Chinese medicine extract C include Scrophularia ningpoensis, Stemona radix (processed), Asparagus cochinchinensis, Ophiopogon japonicus, Rehmannia glutinosa, and Isatis indigotica; the raw materials of the traditional Chinese medicine extract D include Oroxylum indicum and Cicada slough. Through the above components and a specific process, the present invention provides a pharmaceutical composition with a reasonable formula, clear active ingredients, few impurities, rapid onset, long duration of drug efficacy, small dosage, and a clear material basis for its active ingredients, which nourishes yin and moistens the lungs, relieves cough and itching, and clears the throat. DETAILED DESCRIPTION

[0072] The present invention provides a Chinese medicine composition with detoxification function, its preparation method, and application. Those skilled in the art can refer to the content of this article and appropriately improve the process parameters to achieve the desired effect. It should be noted that all similar substitutions and modifications are obvious to those skilled in the art and fall within the scope of protection of the present invention. The methods and applications of the present invention have been described through preferred embodiments. It is obvious that relevant personnel can modify or appropriately change and combine the methods and applications herein without departing from the content, spirit, and scope of the present invention to implement and apply the technology of the present invention.

[0073] In this application, the term "and / or" describes the association relationship between associated objects, indicating that three relationships may exist. For example, A and / or B can mean: A exists alone, A and B exist at the same time, and B exists alone. A and B can be singular or plural.

[0074] In this application, "at least one" means one or more, and "more than one" means two or more. "At least one of the following" or similar expressions refers to any combination of these items, including any combination of single or plural items.

[0075] It should be understood that in the various embodiments of the present application, the size of the serial numbers of the above-mentioned processes does not mean the order of execution. Some or all of the steps can be executed in parallel or sequentially. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present application.

[0076] The numerical ranges and parameters used in this disclosure are presented as precisely as possible to represent the relevant numerical values of the specific embodiments. However, any numerical value inherently and inevitably contains standard deviations resulting from individual testing methods. Therefore, unless otherwise expressly stated, it should be understood that all numerical ranges or specific data used in this disclosure are subject to reasonable deviation within a certain range, for example, within 1% or 0.5%.

[0077] Some cases are described in the embodiments and comparative examples of the present invention, wherein the embodiments illustrate certain implementations of the present invention. However, this does not mean that the effects of the present invention can only be achieved in these cases.

[0078] To further illustrate the present invention, the following describes in detail a detoxification Chinese medicine composition provided by the present invention, its preparation method and application in combination with examples.

[0079] Example 1:

[0080] Take 1 part of a Chinese herbal extract A for nourishing yin, moistening lungs and clearing throat, 0.5 parts of a Chinese herbal extract B for nourishing yin, moistening lungs and clearing throat, 5 parts of a Chinese herbal extract C for nourishing yin, moistening lungs and clearing throat, and 0.4 parts of a Chinese herbal extract D for nourishing yin, moistening lungs and clearing throat, and mix them evenly.

[0081] Example 2:

[0082] Take 3 parts of a Chinese herbal extract A for nourishing yin, moistening lungs and clearing throat, 1.5 parts of a Chinese herbal extract B for nourishing yin, moistening lungs and clearing throat, 15 parts of a Chinese herbal extract C for nourishing yin, moistening lungs and clearing throat, and 1.2 parts of a Chinese herbal extract D for nourishing yin, moistening lungs and clearing throat, and mix them evenly.

[0083] Example 3:

[0084] Take 5 parts of a Chinese herbal extract A for nourishing yin, moistening lungs and clearing throat, 2.5 parts of a Chinese herbal extract B for nourishing yin, moistening lungs and clearing throat, 25 parts of a Chinese herbal extract C for nourishing yin, moistening lungs and clearing throat, and 2 parts of a Chinese herbal extract D for nourishing yin, moistening lungs and clearing throat, and mix them evenly.

[0085] Example 4:

[0086] Take 3 parts of a traditional Chinese medicine extract A for nourishing yin, moistening lungs and clearing throat, 1.5 parts of a traditional Chinese medicine extract B for nourishing yin, moistening lungs and clearing throat, 15 parts of a traditional Chinese medicine extract C for nourishing yin, moistening lungs and clearing throat, and 1.2 parts of a traditional Chinese medicine extract D for nourishing yin, moistening lungs and clearing throat, mix them with appropriate amounts of starch and sucrose, add povidone K30 solution to prepare granules, and press them into 3000 tablets.

[0087] Example 5:

[0088] Take 3 parts of a Chinese herbal extract A for nourishing yin, moistening lungs and clearing throat, 1.5 parts of a Chinese herbal extract B for nourishing yin, moistening lungs and clearing throat, 15 parts of a Chinese herbal extract C for nourishing yin, moistening lungs and clearing throat, and 1.2 parts of a Chinese herbal extract D for nourishing yin, moistening lungs and clearing throat, mix them with appropriate amounts of sucrose and aspartame, add appropriate amount of ethanol, and prepare 3000 bags of granules.

[0089] Example 6:

[0090] Take 3 parts of a Chinese herbal extract A for nourishing yin, moistening lungs and clearing throat, 1.5 parts of a Chinese herbal extract B for nourishing yin, moistening lungs and clearing throat, 15 parts of a Chinese herbal extract C for nourishing yin, moistening lungs and clearing throat, and 1.2 parts of a Chinese herbal extract D for nourishing yin, moistening lungs and clearing throat, mix them with an appropriate amount of corn starch, and prepare 3000 capsules.

[0091] Comparative Example 1: 0.8 parts of a Chinese herbal extract A for nourishing yin, moistening lungs and clearing throat, 0.4 parts of a Chinese herbal extract B for nourishing yin, moistening lungs and clearing throat, 4 parts of a Chinese herbal extract C for nourishing yin, moistening lungs and clearing throat, and 0.3 parts of a Chinese herbal extract D for nourishing yin, moistening lungs and clearing throat were taken in proportion and mixed evenly.

[0092] Comparative Example 2: 5.5 parts of a Chinese herbal extract A for nourishing yin, moistening lungs and clearing throat, 3 parts of a Chinese herbal extract B for nourishing yin, moistening lungs and clearing throat, 25.5 parts of a Chinese herbal extract C for nourishing yin, moistening lungs and clearing throat, and 2.5 parts of a Chinese herbal extract D for nourishing yin, moistening lungs and clearing throat were taken in proportion and mixed evenly.

[0093] Comparative Example 3: Take 120g of Scrophulariaceae, 90g of Stemona (processed), 90g of Asparagus cochinchinensis, 90g of Moutan Bark, 90g of Ophiopogon japonicus, 30g of Oroxylum indicum, 90g of Rehmannia glutinosa, 150g of Isatis indigotica, 90g of Green Fruit, and 30g of Periostracum cicadae, decoct in water twice, filter the decoction, concentrate into a thick paste with a relative density of 1.20-1.40 (60°C), dry, and grind into fine powder; take 90g of Coltsfoot flower (processed), grind into 200-mesh superfine powder, mix evenly with the above-mentioned fine powder and 40g of mannitol, 40g of powdered sugar, 0.2g of coffee creamer, and 0.8g of aspartame, add appropriate amount of water to make granules, dry, spray 0.3g of peppermint oil, and mix evenly.

[0094] Comparative Example 4: Take 120g of Scrophulariaceae, 90g of Stemona, 90g of Asparagus cochinchinensis, 90g of Moutan Cortex, 90g of Ophiopogon japonicus, 90g of Coltsfoot Flos, 30g of Oroxylum indicum, 90g of Rehmannia glutinosa, 150g of Isatis indigotica, 90g of Green Fruit, 30g of Periostracum cicada, and 0.3g of peppermint oil, add them into a CO2 supercritical extractor, use ethanol as an entrainer, the entrainer accounts for 5% by volume of the total extraction solvent, the extraction pressure is 15MPa, the temperature is 30°C, the CO2 flow rate is 2ml / g crude drug min, and the extraction time is 150min to obtain a supercritical extract, add starch, and 70% ethanol to make granules, dry, and mix uniformly.

[0095] Comparative Example 5: Take 120g of Scrophulariaceae, 90g of Stemona, 90g of Asparagus cochinchinensis, 90g of Paeonia suffruticosa, 90g of Ophiopogon japonicus, 30g of Oroxylum indicum, 90g of Rehmannia glutinosa, 150g of Isatis indigotica, 90g of Green Fruit, and 30g of Periostracum cicadae, and perform dynamic countercurrent extraction with 10 times the amount of 10% ethanol as the extraction solvent. At the same time, ultrasonic treatment is performed on both sides of the dynamic countercurrent extractor, the ultrasonic frequency is 50KHz, the extraction temperature is 80°C, and the extraction time is 80min; the extract is concentrated under reduced pressure, and the extract and 90g of coltsfoot flower powder are mixed with an appropriate amount of 70% ethanol to form granules, which are dried and mixed evenly.

[0096] Test example: efficacy test:

[0097] Chronic pharyngitis is a highly prevalent inflammatory disease of the upper respiratory tract that can cause mucosal hyperplasia, glandular enlargement, vasodilation, and increased mucus secretion. This is accompanied by a pathological response regulated by inflammatory mediators such as prostaglandin E2 (PGE2) and CRP (C-reactive protein), as well as inflammatory cells such as lymphocytes and leukocytes. Clinical manifestations include itchy, dry, sore throats, coughs, and the presence of foreign bodies or throat obstruction. Some people also experience fever caused by the inflammation.

[0098] Experimental methods:

[0099] 1. Antitussive effect

[0100] 150 ICR mice, half male and half female, weighing 18-22g, were randomly divided into blank group, model group, western medicine positive group (Qinghou Liyan granules, 5.19g crude drug / kg), original process group (Yingyan tablets, 5.62g crude drug / kg), composition group 1, composition group 2, composition group 3, composition group 4, composition group 5, composition group 6, comparative example group 1, comparative example group 2, comparative example group 3, comparative example group 4, comparative example group 5, with 10 mice in each group, and the dosage was 10ml / kg. After 15 days of preventive administration, chronic pharyngitis models were established in the remaining 14 groups except the blank control group: the upper jaw of the mouse was opened with sterile tweezers, the mucosa was punctured in a near horizontal direction with a syringe, and 8×10 beta-hemolytic streptococci were injected. 8 CFU·mL -1Each mouse was injected with 0.01 mL of bacterial solution, once every 3 days, for a total of 5 times, and the drug was continuously administered during the modeling period.

[0101] One hour after the last administration, mice in all groups except the normal control group were placed in a glass cover sprayed with a certain amount of concentrated ammonia solution. The cough latency (the time from the mouse entering the ammonia-filled beaker to the first cough) and the number of coughs in the mice within 2 minutes were observed and recorded. Mice in the blank group were not stimulated with ammonia solution, and the cough latency and number of coughs in the mice were directly recorded within 2 minutes.

[0102] 2. Expectorant effect

[0103] 140 ICR mice, half male and half female, weighing 18-22 g, were randomly divided into a model group, a western medicine positive group (Pudilan Xiaoyan Tablets, dose of 3.28 g crude drug / kg), an original process group (Yingyan Tablets, dose of 5.62 g crude drug / kg), a composition group 1, a composition group 2, a composition group 3, a composition group 4, a composition group 5, a composition group 6, a comparative example group 1, a comparative example group 2, a comparative example group 3, a comparative example group 4, and a comparative example group 5, with 10 mice in each group. After 15 days of preventive administration, a chronic pharyngitis model was established: the mouse's upper jaw was opened with sterile tweezers, the mucosa was punctured in a near horizontal direction with a syringe, and 8×10 beta-hemolytic streptococci were injected. 8 CFU·mL -1 Each rat was injected with 0.01 mL of bacterial solution, once every 3 days, for a total of 5 times, and 10 ml / kg was continuously administered during the modeling period.

[0104] 0.5 h after the last dose, mice were intraperitoneally injected with 0.4% phenol red in saline at a rate of 0.01 mL / g. 30 min after the injection, mice were sacrificed by cervical dislocation. Peribronchial muscle tissue was stripped, and a section of trachea from the thyroid cartilage to the tracheal bifurcation was excised and placed in an EP tube filled with 2 mL of saline. After vortexing for 5 min, the tube was ultrasonically cleaned for 20 min, and then 1 mL of 5% NaHCO₃ solution was added dropwise. The tube was centrifuged at 2500 rpm for 10 min. The OD value of each group was measured at 546 nm using a visible spectrophotometer with 5% NaHCO₃ as the standard solution. A standard curve was constructed using 5% phenol red solution, and the phenol red content was calculated from the standard curve.

[0105] 3. Antipyretic effect

[0106] 170 SD rats, half male and half female, weighing 180-220g, were randomly divided into a blank group, a model group, a Western medicine-positive group (Metrin, dose of 3.6ml / kg), an original process group (Yingyan Tablet, dose of 3.89g crude drug / kg), Composition Group 1, Composition Group 2, Composition Group 3, Composition Group 4, Composition Group 5, Composition Group 6, and Comparative Example Group 1, Comparative Example Group 2, Comparative Example Group 3, Comparative Example Group 4, and Comparative Example Group 5, with 10 rats in each group. Animals were fasted for 6 hours prior to the experiment and their stools were empty. Body temperature was measured twice, 10 minutes apart, before modeling, and the average was used as basal body temperature. A fever model was established in rats by subcutaneous injection of 0.15% 2,4-dinitrophenol (1mL / 100g) on the back. The blank group was injected with an equal amount of normal saline. At the same time, rats in each group were orally administered 10 mL / kg, and the rectal temperature of the rats was measured 0.5, 1, 1.5, 2, 2.5, and 3 hours after administration.

[0107] 4. Anti-inflammatory Effect

[0108] 140 ICR mice, half male and half female, weighing 18-22g, were randomly divided into a model group, a western medicine positive group (amoxicillin dispersible tablets, with a dose of 4.46g / kg), an original process group (pharyngitis tablets, with a dose of 5.62g crude drug / kg), a composition group 1, a composition group 2, a composition group 3, a composition group 4, a composition group 5, a composition group 6, a comparative example group 1, a comparative example group 2, a comparative example group 3, a comparative example group 4, and a comparative example group 5, with 10 mice in each group. The mice were given the drug by gavage once a day at a dose of 10ml / kg for 7 consecutive days. One hour after the last administration, 50uL of xylene was applied to both sides of the left ear of the mouse to cause inflammation, and normal saline was applied to the same position on the right side. The mice were killed by cervical dislocation 15 minutes later.

[0109] Use an 8mm punch to punch discs from the same area of the left and right ears. Weigh the discs and calculate the swelling degree and swelling inhibition rate as follows: Swelling degree = left ear disc mass - right ear disc mass. Ear swelling inhibition rate = (model ear swelling degree - treatment group ear swelling degree) / model ear swelling degree × 100%.

[0110] 150 SD rats, half male and half female, weighing 180-200g, were randomly divided into a blank group, a model group, a Western medicine-positive group (aspirin, dose of 3.18g / kg), an original process group (pharyngitis tablets, dose of 3.89g crude drug / kg), Composition 1, Composition 2, Composition 3, Composition 4, Composition 5, Composition 6, and Comparative Example 1, Comparative Example 2, Comparative Example 3, Comparative Example 4, and Comparative Example 5, with 10 rats in each group. Rats were administered orally once daily for 7 consecutive days at a dose of 10ml / kg. One hour after the last dose, rats in all groups except the blank group were injected with 7.5mg / kg of lipopolysaccharide. Six hours after administration, blood was collected from the eyeballs and the rats were sacrificed by cervical dislocation. The collected blood samples were immediately centrifuged at 3000rpm / min at 4°C for 15 minutes, and the supernatant was collected and stored at -20°C. The ELISA method was used to detect the levels of PGE2 (prostaglandin E2) and CRP (C-reactive protein) in serum.

[0111] Statistical Analysis

[0112] Excel statistical analysis method was used for data analysis. The comparison of sample means among multiple groups was performed using one-way analysis of variance. P < 0.05, P < 0.01, and P < 0.001 were considered statistically significant.

[0113] Experimental results

[0114] 1. Antitussive effect experimental results

[0115] Compared with the blank group, the model group had a significantly decreased cough incubation period (P<0.001) and a significantly increased cough frequency (P<0.001), indicating that the model was successfully established. Compared with the model group, Chinese medicine composition group 1, Chinese medicine composition group 2, Chinese medicine composition group 3, Chinese medicine composition group 4, Chinese medicine composition group 5, and Chinese medicine composition group 6 could prolong the cough incubation period of mice (P<0.05, P<0.001); compared with control group 1, Chinese medicine composition group 1, Chinese medicine composition group 2, Chinese medicine composition group 3, Chinese medicine composition group 4, Chinese medicine composition group 5, and Chinese medicine composition group 6 could prolong the cough incubation period of mice (P<0.05, P<0.01, P<0.001); compared with control group 2, Chinese medicine composition group 1, Chinese medicine composition group 2, Chinese medicine composition group 3, Chinese medicine composition group 4, Chinese medicine composition group 5, and Chinese medicine composition group 6 could prolong the cough incubation period of mice (P<0.001); compared with control group 3, , Chinese medicine composition group 1, Chinese medicine composition group 2, Chinese medicine composition group 3, Chinese medicine composition group 4, Chinese medicine composition group 5, and Chinese medicine composition 6 can prolong the latent period of cough in mice (P<0.05, P<0.001); compared with the comparison example group 4, Chinese medicine composition group 1, Chinese medicine composition group 2, Chinese medicine composition group 3, Chinese medicine composition group 4, Chinese medicine composition group 5, and Chinese medicine composition 6 can prolong the latent period of cough in mice (P<0.05, P<0.01, P<0.001); compared with the comparison example group 5, Chinese medicine composition group 1, Chinese medicine composition group 2, Chinese medicine composition group 3, Chinese medicine composition group 4, Chinese medicine composition group 5, and Chinese medicine composition 6 can prolong the latent period of cough in mice (P<0.05, P<0.01, P<0.001). Compared with the model group, the coughing times of mice in group 1, group 2, group 3, group 4, group 5 and group 6 were significantly reduced (P<0.05, P<0.001). Compared with the control group 1, the coughing times of mice in group 1, group 2, group 3, group 4, group 5 and group 6 were significantly reduced (P<0.01, P<0.001). Compared with the control group 2, the coughing times of mice in group 1, group 2, group 3, group 4, group 5 and group 6 were significantly reduced (P<0.01, P<0.001). Composition Group 2 showed a decrease in the number of coughs in mice (P<0.01); compared with Comparative Example Group 3, Chinese medicine composition Group 2 showed a decrease in the number of coughs in mice (P<0.01); compared with Comparative Example Group 4, Chinese medicine composition Group 2 showed a decrease in the number of coughs in mice (P<0.01); compared with Comparative Example Group 5, Chinese medicine composition Groups 2, 3, 4, 5, and 6 showed a decrease in the number of coughs in mice (P<0.05, P<0.01, and P<0.001). See Table 1.

[0116] Table 1 Cough latency and cough frequency in mice ( n=10)

[0117]

[0118] Note: Compared with the blank group, ### P<0.001; compared with the model group, * P<0.05, *** P<0.001; compared with control group 1, aa P<0.01, aaa P<0.001; compared with control group 2, bb P<0.01; compared with control group 3, c P < 0.05; cc P<0.01; compared with control group 4, dd P<0.01; compared with control group 5, e P<0.05, ee P<0.01, eee P<0.001.

[0119] 2. Expectorant effect experimental results

[0120] Compared with the model group, the original process group, Chinese medicine composition group 1, Chinese medicine composition group 2, Chinese medicine composition group 3, Chinese medicine composition group 4, Chinese medicine composition group 5, Chinese medicine composition group 6, and comparative example group 3 could increase the excretion of phenol red (P<0.05, P<0.01, P<0.001), and promote the secretion of phenol red in the respiratory tract of mice; compared with the comparative example group, Chinese medicine composition group 1, Chinese medicine composition group 2, Chinese medicine composition group 3, Chinese medicine composition group 4, Chinese medicine composition group 5, and Chinese medicine composition group 6 could increase the excretion of phenol red (P<0.05, P<0.01, P<0.001); compared with comparative example group 2, Chinese medicine combination group 2 increased the excretion of phenol red (P<0.001); compared with comparative example group 3, Compared with the control group, the Chinese medicine composition group 1, the Chinese medicine composition group 2, the Chinese medicine composition group 3, the Chinese medicine composition group 4, the Chinese medicine composition group 5 and the Chinese medicine composition group 6 could increase the excretion of phenol red (P<0.05, P<0.01, P<0.001); compared with the control group 4, the Chinese medicine composition group 1, the Chinese medicine composition group 2, the Chinese medicine composition group 3, the Chinese medicine composition group 4 and the Chinese medicine composition group 5 could increase the excretion of phenol red (P<0.05, P<0.01, P<0.001); compared with the control group 5, the Chinese medicine composition group 1, the Chinese medicine composition group 2, the Chinese medicine composition group 4 and the Chinese medicine composition group 5 could increase the excretion of phenol red (P<0.05, P<0.01, P<0.001), see Table 2.

[0121] Table 2 Phenol red excretion in mouse trachea ( n=10)

[0122]

[0123]

[0124] Note: Compared with the model group, * P<0.05, ** P<0.01, *** P<0.001; compared with control group 1, a P<0.05, aa P<0.01, aaa P<0.001; compared with control group 2, bbb P<0.001; compared with control group 3, c P<0.05, cc P<0.01, ccc P<0.001; compared with control group 4, d P<0.05, dd P<0.01, ddd P<0.001; compared with control group 5, e P<0.05, ee P<0.01, eee P<0.001.

[0125] 3. Antipyretic effect experimental results

[0126] Compared with the blank group, the rectal temperature of the rats in the model group increased significantly at all time points (P<0.05, P<0.01, P<0.001). At 0.5 h, compared with the model group, the body temperature of the rats in the TCM composition group 2 and TCM composition group 4 decreased significantly (P<0.05, P<0.01). Compared with the control group 1, the body temperature of the rats in the TCM composition group 2 and TCM composition group 4 decreased significantly (P<0.05). Compared with the control group 2, the body temperature of the rats in the TCM composition group 2 and TCM composition group 4 decreased significantly (P<0.01). Compared with the control group 3, the body temperature of the rats in the TCM composition group 2 decreased significantly (P<0.05). Compared with the control group 4, the body temperature of the rats in the TCM composition group 2 and TCM composition group 4 decreased significantly (P<0.05).

[0127] At 1 hour: the body temperatures of the rats in the TCM composition group 2, the TCM composition group 4, and the TCM composition group 5 were significantly lower than those in the model group (P<0.05, P<0.001); compared with the control group 1, the body temperatures of the rats in the TCM composition group 2, the TCM composition group 4, and the TCM composition group 5 were significantly reduced (P<0.05, P<0.001); compared with the control group 2, the body temperatures of the rats in the TCM composition group 2, the TCM composition group 4, and the TCM composition group 5 were significantly reduced (P<0.05, P<0.001); compared with the control group 3, the body temperatures of the rats in the TCM composition group 2 were significantly reduced (P<0.001); compared with the control group 4, the body temperatures of the rats in the TCM composition group 2 were significantly reduced (P<0.05); compared with the control group 5, the body temperatures of the rats in the TCM composition group 2 were significantly reduced (P<0.001).

[0128] At 2 hours: the body temperatures of the rats in the TCM composition 2 group, TCM composition 4 group, TCM composition 5 group, and TCM composition 6 group were significantly lower than those in the model group (P<0.05, P<0.001); compared with the comparative example 1 group, the body temperatures of the rats in the TCM composition 2 group, TCM composition 4 group, TCM composition 5 group, and TCM composition 6 group were significantly lower than those in the model group (P<0.01, P<0.001); compared with the comparative example 2 ...5 group, and TCM composition 6 group were significantly lower than those in the model group (P<0.01, P<0.001). The body temperatures of the rats were significantly lower than those in the model group (P<0.05, P<0.001). Compared with the control group 4, the body temperatures of the rats in the Chinese medicine composition group 2 and the Chinese medicine composition group 5 were significantly lower than those in the model group (P<0.01, P<0.001). Compared with the control group 5, the body temperatures of the rats in the Chinese medicine composition group 2, the Chinese medicine composition group 4, the Chinese medicine composition group 5, and the Chinese medicine composition group 6 were significantly lower than those in the model group (P<0.05, P<0.01, P<0.001).

[0129] At 3 hours: the body temperatures of the rats in the original process group, Chinese medicine composition group 2, Chinese medicine composition group 4, Chinese medicine composition group 5, and comparative example group 3 were significantly lower than those in the model group (P<0.05, P<0.001); compared with comparative example group 1, the body temperatures of the rats in Chinese medicine composition group 2 were significantly lower than those in the model group (P<0.05); compared with comparative example group 2, the body temperatures of the rats in Chinese medicine composition group 2 were significantly lower than those in the model group (P<0.01); compared with comparative example group 4, the body temperatures of the rats in Chinese medicine composition group 2 were significantly lower than those in the model group (P<0.01); compared with comparative example group 5, the body temperatures of the rats in Chinese medicine composition group 2 were significantly lower than those in the model group (P<0.05);

[0130] At 4 hours: the body temperatures of the rats in the TCM composition 2, TCM composition 4, and TCM composition 5 groups were significantly lower than those in the model group (P<0.05, P<0.001); compared with the comparative example 1 group, the body temperatures of the rats in the TCM composition 2, TCM composition 3, TCM composition 5, and TCM composition 6 groups were significantly lower than those in the model group (P<0.05, P<0.01, P<0.001); compared with the comparative example 2 group, the body temperatures of the rats in the TCM composition 2, TCM composition 5, and TCM composition 6 groups were significantly lower than those in the model group (P<0.05, P<0.01, P<0.001). The body temperatures of the rats were significantly lower than those in the model group (P<0.05, P<0.001). Compared with the control group 3, the body temperatures of the rats in the Chinese medicine composition group 4 were significantly lower than those in the model group (P<0.05). Compared with the control group 4, the body temperatures of the rats in the Chinese medicine composition group 2 were significantly lower than those in the model group (P<0.01). Compared with the control group 5, the body temperatures of the rats in the Chinese medicine composition group 2, the Chinese medicine composition group 5, and the Chinese medicine composition group 6 were significantly lower than those in the model group (P<0.05, P<0.001).

[0131] The body temperatures of the rats in the original process group, the Chinese medicine composition group 2, and the comparative example group 3 were significantly lower than those in the model group at 6 h (P<0.05, P<0.001); compared with the comparative example group 1, the body temperatures of the rats in the Chinese medicine composition group 2 were significantly lower than those in the model group (P<0.001); compared with the comparative example group 2, the body temperatures of the rats in the Chinese medicine composition group 2, the Chinese medicine composition group 4, and the Chinese medicine composition group 6 were significantly lower than those in the model group (P<0.05, P<0.001); compared with the comparative example group 4, the body temperatures of the rats in the Chinese medicine composition group 2 were significantly lower than those in the model group (P<0.05); compared with the comparative example group 5, the body temperatures of the rats in the Chinese medicine composition group 2 were significantly lower than those in the model group (P<0.01). See Table 3 for details.

[0132] Table 3 Changes in rectal temperature of rats at different time points (℃, n=10)

[0133]

[0134]

[0135] Note: Compared with the blank group, ### P<0.001; compared with the model group, * P<0.05, *** P<0.001; compared with control group 1, a P<0.05, aa P<0.01, aaa P<0.001; compared with control group 2, b P<0.05, bb P<0.01, bbb P<0.001; compared with the control group 3, c P<0.05,ccc P<0.001; compared with the control group 4, d P<0.05, dd P<0.01, ddd P<0.001; compared with comparative example 5, e P<0.05, ee P<0.01, eee P<0.001.

[0136] 4. Anti-inflammatory effect experimental results

[0137] Compared with the blank group, the ear swelling of the mice in the original process group, the Chinese medicine composition group 2, the Chinese medicine composition group 4, the Chinese medicine composition group 5, and the Chinese medicine composition group 6 were reduced to varying degrees (P<0.01, P<0.01, P<0.001); Compared with the comparative example group 1, the ear swelling of the mice in the Chinese medicine composition group 1, the Chinese medicine composition group 2, the Chinese medicine composition group 3, the Chinese medicine composition group 4, the Chinese medicine composition group 5, and the Chinese medicine composition group 6 were reduced to varying degrees (P<0.05, P<0.01, P<0.001); Compared with the comparative example group 2, the ear swelling of the mice in the original process group, the Chinese medicine composition group 2, the Chinese medicine composition group 3, the Chinese medicine composition group 4, The ear swelling of the mice in the Chinese medicine composition group 5 and the Chinese medicine composition group 6 was reduced to varying degrees (P<0.001); compared with the control group 3, the ear swelling of the mice in the Chinese medicine composition group 2 was reduced to varying degrees (P<0.001); compared with the control group 4, the ear swelling of the mice in the Chinese medicine composition group 2 was reduced to varying degrees (P<0.001); compared with the control group 5, the ear swelling of the mice in the Chinese medicine composition group 1, the Chinese medicine composition group 2, the Chinese medicine composition group 3, the Chinese medicine composition group 4, the Chinese medicine composition group 5, and the Chinese medicine composition group 6 were reduced to varying degrees (P<0.05, P<0.01, P<0.001), see Table 4 for details.

[0138] Table 4 Ear swelling degree and ear swelling inhibition rate of mice in each group ( n=10)

[0139]

[0140]

[0141] Note: Compared with the blank group, ** P<0.01, *** P<0.001; compared with control group 1, a P<0.05, aa P<0.01, aaa P<0.001; compared with control group 2, bbb P<0.001; compared with the control group 3, cccP<0.001; compared with the control group 4, ddd P<0.001; compared with control group 5, e P<0.05, ee P<0.01, eee P<0.001.

[0142] Compared with the blank group, the serum PGE2 and CRP levels of the mice in the model group were significantly increased (P<0.001); compared with the model group, the serum PGE2 levels of the rats in the original process group, the Chinese medicine composition group 2, the Chinese medicine composition group 4, the Chinese medicine composition group 5, and the Chinese medicine composition group 6 were significantly decreased (P<0.05, P<0.01, P<0.001); compared with the control group 1, the serum PGE2 levels of the rats in the Chinese medicine composition group 2 were significantly decreased (P<0.001); compared with the control group 2, the serum PGE2 levels of the rats in the Chinese medicine composition group 2 were significantly decreased (P<0.001); compared with the control group 2, the serum PGE2 levels of the rats in the Chinese medicine composition group 2 were significantly decreased (P<0.001). The serum PGE2 content of rats was significantly reduced (P<0.001); compared with the control group 3, the serum PGE2 content of rats in the Chinese medicine composition group 2 was significantly reduced (P<0.001); compared with the control group 4, the serum PGE2 content of rats in the Chinese medicine composition group 2 and the Chinese medicine composition group 4 was significantly reduced (P<0.05, P<0.001); compared with the control group 5, the serum PGE2 content of rats in the Chinese medicine composition group 2 and the Chinese medicine composition group 4 was significantly reduced (P<0.05, P<0.001). Compared with the model group, the serum CRP levels of the rats in the Chinese medicine composition group 2, the Chinese medicine composition group 4, the Chinese medicine composition group 5, and the Chinese medicine composition group 6 were significantly reduced (P<0.05, P<0.01, P<0.001); compared with the control group 1, the serum CRP levels of the rats in the Chinese medicine composition group 2 were significantly reduced (P<0.01); compared with the control group 2, the serum CRP levels of the rats in the Chinese medicine composition group 2 were significantly reduced (P<0.001); compared with the control group 3, the serum CRP levels of the rats in the Chinese medicine composition group 2, The serum CRP levels of rats in the TCM composition group 4 and TCM composition group 5 were significantly reduced (P < 0.05, P < 0.01, P < 0.001). Compared with the control group 4, the serum CRP levels of rats in the TCM composition group 2 and TCM composition group 5 were significantly reduced (P < 0.05, P < 0.001). Compared with the control group 5, the serum CRP levels of rats in the TCM composition group 2, TCM composition group 4, and TCM composition group 5 were significantly reduced (P < 0.05, P < 0.001). See Table 5 for details.

[0143] Table 5 PGE2 and CRP levels in serum of rats in each group ( n=10)

[0144]

[0145]

[0146] Note: Compared with the blank group, ### P<0.001; compared with the model group, * P<0.05, ** P<0.01, *** P<0.001; compared with control group 1, a P<0.01, aaa P<0.001; compared with control group 2, bbb P<0.001; compared with the control group 3, c P<0.05, cc P<0.01, ccc P<0.001; compared with the control group 4, d P<0.05, ddd P<0.001; compared with control group 5, e P<0.05, eee P<0.001.

[0147] in conclusion:

[0148] The Chinese medicine compositions of groups 1 and 3 have certain antitussive and expectorant effects, the Chinese medicine compositions of groups 2, 4, 5, and 6 have antitussive, expectorant, antipyretic, and anti-inflammatory effects, and the original process group and comparative example group 3 have expectorant and anti-inflammatory effects. The results show that: (1) the effect of Chinese medicine composition group 2 is better than that of Chinese medicine compositions of groups 1, 3, 4, 5, and 6; (2) the effect of Chinese medicine compositions of groups 4, 5, and 6 is better than that of Chinese medicine compositions of groups 1 and 3; (3) the effect of Chinese medicine compositions of groups 1-6 is better than that of the original process group; (4) the effect of comparative example group 3 is equivalent to that of the original process group; comparative example groups 1, 2, 4, and 5 have no obvious antitussive, expectorant, antipyretic, and anti-inflammatory effects. (5) The antitussive, expectorant, antipyretic, and anti-inflammatory effects of the Chinese medicine compositions are better than those of the comparative example. In summary, the Chinese medicine composition group 2 of the present invention has obvious antitussive, expectorant, antipyretic, and anti-inflammatory effects, and is better than Chinese medicine compositions of groups 1, 3, 4, 5, and 6, the original process preparation, and comparative example groups 1-5.

[0149] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition, characterized in that The invention comprises the following raw materials in parts by weight: 1-5 parts of Chinese herbal medicine extract A, 0.5-2.5 parts of Chinese herbal medicine extract B, 5-25 parts of Chinese herbal medicine extract C, and 0.4-2 parts of Chinese herbal medicine extract D; The raw materials of the Chinese herbal medicine extract A include coltsfoot flower, green fruit, mint oil and β-cyclodextrin; The raw materials of the Chinese medicine extract B include peony bark; The raw materials of the Chinese medicine extract C include Scrophularia ningpoensis, Stemona radix (processed), Asparagus cochinchinensis, Ophiopogon japonicus, Rehmannia glutinosa and Isatis indigotica; The raw materials of the Chinese medicine extract D include Oroxylum indicum and Cicada slough.

2. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition comprises the following raw materials in parts by weight: 2-4 parts of Chinese herbal medicine extract A, 1-2 parts of Chinese herbal medicine extract B, 10-20 parts of Chinese herbal medicine extract C, and 0.8-1.8 parts of Chinese herbal medicine extract D.

3. The Chinese medicine composition according to claim 1 or 2, characterized in that The preparation method of the Chinese medicine extract A comprises: Taking coltsfoot flower and water, mixing and soaking, and then steam distilling and extracting, to obtain coltsfoot flower oil and medicinal residue a; The green fruit is crushed, soaked, and then steam distilled to obtain green fruit volatile oil and medicinal residue b; Peppermint oil, coltsfoot flower oil, green fruit volatile oil, β-cyclodextrin and water are mixed and ground in a colloid mill to obtain an inclusion compound, which is freeze-dried and crushed to obtain the Chinese medicine extract A.

4. The Chinese medicine composition according to claim 1 or 2, characterized in that The preparation method of the Chinese medicine extract B comprises: Crushing the peony bark, extracting it by steam distillation, and obtaining a distillate and a medicinal residue c; Add hydrochloric acid to the distillate, let it stand, filter, wash, dry at low temperature, and crush to obtain Chinese medicine extract B; The mesh size of the peony bark crushed is 24 meshes; the distillation time is 5 to 6 hours; the concentration of hydrochloric acid is 1 mol / L; the standing time is 24 to 36 hours; and the low-temperature drying temperature is 35 to 40°C.

5. The Chinese medicine composition according to claim 1 or 2, characterized in that The preparation method of the Chinese medicine extract C comprises: The medicinal residues a, b, c, Scrophularia ningpoensis, Stemona radix (processed), Asparagus cochinchinensis, Radix Ophiopogonis, Radix Rehmanniae and Radix Isatidis were mixed with water for extraction under reflux, the decoctions were combined, filtered, purified by macroporous adsorption resin, and the eluate was collected and concentrated to obtain a thick paste; the thick paste was dried under reduced pressure and crushed to obtain Chinese medicinal extract C; The mass ratio of Scrophulariaceae, Stemona (processed), Asparagus cochinchinensis, Ophiopogon japonicus, Rehmannia root and Isatis indigotica is 10:10:10:10:10:10; the reflux extraction is performed twice; the filtration is performed through a 300-mesh filter; the relative density of the thick paste is 1.28-1.30; the temperature for reduced-pressure drying is 60-80° C.; and the mesh size of the pulverization is 80-100 mesh. The parameters of the macroporous adsorption resin purification include: the diameter-to-height ratio of the macroporous adsorption resin is 1:5; the sample loading flow rate is 1-2 BV / h; after loading, the macroporous resin column is rinsed with purified water until the effluent water is colorless, and then eluted with 70% ethanol; the flushing flow rate is 1-2 BV / h; and the 70% ethanol elution flow rate is 1 BV / h.

6. The Chinese medicine composition according to claim 1 or 2, characterized in that The preparation method of the Chinese medicine extract D comprises: Mix Oroxylum butterfly and Cicada shell with 70% ethanol, extract under reflux, filter, concentrate to a thick paste, dry, and grind to obtain Chinese medicine extract D; The mass ratio of the oroxylum butterfly and the cicada shell is 10:10; the relative density of the thick paste is 1.25-1.28; the number of reflux extractions is two; the time of each reflux extraction is 1-2 hours; the temperature of the reduced pressure drying is 60-80° C.; and the mesh size of the crushing is 80-100 meshes.

7. A method for preparing the traditional Chinese medicine composition for nourishing yin, moistening lungs and clearing throat according to any one of claims 1 to 6, characterized in that: The steps include: The Chinese herbal medicine extract A, Chinese herbal medicine extract B, Chinese herbal medicine extract C and Chinese herbal medicine extract D are mixed to obtain the product.

8. Use of the traditional Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a medicament for nourishing yin, moistening the lungs and clearing the throat.

9. A medicine for nourishing yin, moistening lungs and clearing throat, characterized in that: A Chinese medicinal composition with detoxification function comprising the detoxification function of any one of claims 1 to 6.

10. The drug according to claim 9, characterized in that The dosage form of the drug includes tablets, granules or capsules; The medicine further comprises excipients; the excipients include fillers, adhesives, wetting agents or flavoring agents; The filler includes one or more of starch, dextrin, microcrystalline cellulose, mannitol, sucrose or lactose; the binder includes one or more of povidone K30 or syrup; the wetting agent includes ethanol; and the flavoring agent includes one or more of essence, stevia or aspartame.

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