Traditional Chinese medicine composition and application thereof as well as traditional Chinese medicine preparation and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition, application thereof, a traditional Chinese medicine preparation and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw materials: radix scutellariae, radix angelicae, rhizoma atractylodis, honeysuckle flower, cortex phellodendri, semen coicis, radix achyranthis bidentatae, radix sophorae flavescentis, cortex dictamni, fructus kochiae, cicada slough and liquorice root. According to the traditional Chinese medicine composition, twelve medicines such as scutellaria baicalensis are compounded, so that the traditional Chinese medicine composition not only can treat rhinitis and pharyngitis, but also can relieve thickening and hypertrophy of adenoid bodies, effectively improves clinical symptoms of adenoid hypertrophy such as nasal obstruction, mouth breathing and snoring, and has a remarkable effect on treating adenoid hypertrophy.

Description

Technical Field

[0001] The present application belongs to the technical field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition and its application, a traditional Chinese medicine preparation and its preparation method. Background Art

[0002] Adenoids hypertrophy refers to the pathological proliferation or hypertrophy of the adenoids caused by repeated inflammatory stimulation. The main clinical manifestations are nasal congestion, mouth breathing, and snoring. Children are at high risk of adenoids hypertrophy. If not treated in time, it may affect the growth and intellectual development of children, and in severe cases may lead to asthma.

[0003] At present, the clinical treatment methods for adenoid hypertrophy in children mainly include surgical treatment and conservative treatment. Among them, surgical treatment can be performed by low-temperature plasma adenoidectomy or adenoidectomy. However, surgical treatment is often accompanied by intraoperative risks such as bleeding, infection, and pharyngeal canal injury, as well as postoperative complications and sequelae. Conservative treatment mostly uses anti-infective drugs, hormone drugs, anti-inflammatory drugs, and anti-allergic drugs, but children have poor tolerance to medication, and have large side effects, making it difficult to continue treatment.

[0004] The etiology and pathology of adenoids hypertrophy in children are: children's lungs are often insufficient, and lung qi deficiency fails to spread and descend, resulting in obstruction of water distribution and accumulation of fluid into phlegm; repeated external infection, lung failure to spread and descend, qi stagnation, phlegm with qi obstruction, depression and heat, phlegm heat fumigation, qi and blood stagnation in the nasopharynx, blocking the airway and forming polyps; children's irregular diet and intestinal stagnation lead to qi stagnation in the middle jiao, abnormal function of receiving and digesting water and grain, stomach qi reversal, stomach heat burning the lung metal, resulting in the lung unable to receive qi, soil unable to produce gold, internal and external evils combined, phlegm, heat, and food intertwined, disturbing the clear orifices, blocking the airway and causing snoring. Treatment of adenoids hypertrophy: clearing lung and stomach heat, resolving phlegm and dispersing nodules. Therefore, traditional Chinese medicine can be used to treat adenoids hypertrophy symptomatically. Summary of the invention

[0005] The purpose of the present application is to provide a Chinese medicine composition and its application, a Chinese medicine preparation and its preparation method, so as to solve the technical problems that the existing anti-infective drugs, hormone drugs, anti-inflammatory drugs and anti-allergic drugs for the treatment of adenoids hypertrophy in children have poor tolerance, large side effects and are difficult to continue treatment.

[0006] In order to achieve the above application purpose, the technical solution adopted in this application is as follows:

[0007] In the first aspect, the present invention provides a Chinese medicine composition. The original medicine formula for preparing the Chinese medicine composition in the present invention comprises scutellaria baicalensis, angelica dahurica, atractylodes lancea, honeysuckle, phellodendron chinense, coix seed, cyathula, sophora flavescens, radix difficile, kochia scoparia, periotosis cicada and liquorice.

[0008] The Chinese medicine composition of the embodiment of the present application is compounded with twelve herbs including Scutellaria baicalensis, Angelica dahurica, Atractylodes macrocephala, Lonicera japonica, Phellodendron chinense, Coix lachryma-jobi, Achyranthes bidentata, Sophora flavescens, Dictamni cortex, Kochia scoparia, Periostracum cicadae and Glycyrrhiza uralensis, so that the Chinese medicine composition of the present application can not only treat rhinitis and pharyngitis, but also relieve the thickening and hypertrophy of adenoids, effectively improve the clinical symptoms of adenoids hypertrophy such as nasal congestion, mouth breathing and snoring, and has a significant effect on the treatment of adenoids hypertrophy.

[0009] The second aspect of the embodiment of the present application provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of at least one of a drug for treating adenoids hypertrophy, a drug for treating rhinitis, a drug for treating pharyngitis, a drug for treating purpura, a drug for treating eczema, a drug for treating skin impetigo, and a drug for treating oral ulcers.

[0010] The above-mentioned traditional Chinese medicine composition has good therapeutic effects on rhinitis, pharyngitis and adenoids hypertrophy, and the above-mentioned traditional Chinese medicine composition also has the efficacy of treating purpura, eczema, skin impetigo and oral ulcers, so that the traditional Chinese medicine composition can be used to prepare drugs for treating adenoids hypertrophy, drugs for treating rhinitis, drugs for treating pharyngitis, drugs for treating purpura, drugs for treating eczema, drugs for treating skin impetigo and drugs for treating oral ulcers.

[0011] In a third aspect, the present application provides a Chinese medicine preparation. The Chinese medicine preparation in the present application comprises the Chinese medicine composition described above and pharmaceutically acceptable excipients.

[0012] Since the Chinese medicine composition of the embodiment of the present application has a good therapeutic effect on adenoids hypertrophy, rhinitis, pharyngitis, purpura, eczema, skin impetigo and oral ulcers, the Chinese medicine preparation of the embodiment of the present application also has a good therapeutic effect on adenoids hypertrophy, rhinitis, pharyngitis, purpura, eczema, skin impetigo and oral ulcers.

[0013] In a fourth aspect, the present application provides a method for preparing a Chinese medicine preparation. The Chinese medicine preparation in the present application is a Chinese medicine gel, which contains a gel matrix and a moisturizer. The preparation method of the Chinese medicine preparation in the present application comprises the following steps:

[0014] Performing a first mixing process on the moisturizer and the Chinese medicine composition to obtain a first mixed solution;

[0015] The first mixed liquid is subjected to a heating treatment, and the first mixed liquid and the gel matrix are subjected to a second mixing treatment and a swelling treatment to obtain a second mixed liquid, which is then cooled to obtain a traditional Chinese medicine gel.

[0016] The preparation method of the Chinese medicine preparation in the embodiment of the present application comprises first subjecting the moisturizer and the Chinese medicine composition to a first mixing treatment, and then adding a gel matrix to perform a second mixing treatment and a swelling treatment, so that the prepared Chinese medicine gel has good uniformity and good efficacy, and the preparation method has fewer process steps and is suitable for large-scale industrial production. DETAILED DESCRIPTION

[0017] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present application more clearly understood, the present application is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and are not used to limit the present application.

[0018] In this application, the term "and / or" describes the association relationship of associated objects, indicating that there may be three relationships. 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. The character " / " generally indicates that the associated objects are in an "or" relationship.

[0019] In this application, "at least one" means one or more, and "plurality" 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 items or plural items. For example, "at least one of a, b, or c", or "at least one of a, b, and c" can all mean: a, b, c, a~b (i.e. a and b), a~c, b~c, or a~b~c, where a, b, c can be single or multiple, respectively.

[0020] 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, and 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.

[0021] The terms used in the embodiments of the present application are only for the purpose of describing specific embodiments, and are not intended to limit the present application. The singular forms "a", "an" and "the" used in the embodiments of the present application and the appended claims are also intended to include plural forms, unless the context clearly indicates other meanings.

[0022] The weight of the relevant components mentioned in the embodiment description of the present application can not only refer to the specific content of each component, but also represent the proportional relationship between the weights of the components. Therefore, as long as the content of the relevant components is proportionally enlarged or reduced according to the embodiment description of the present application, it is within the scope disclosed in the embodiment description of the present application. Specifically, the mass in the embodiment description of the present application can be μg, mg, g, kg and other mass units known in the chemical industry.

[0023] The terms "first" and "second" are used only for descriptive purposes to distinguish objects such as substances from each other, and should not be understood as indicating or implying relative importance or implicitly indicating the number of indicated technical features. For example, without departing from the scope of the embodiments of the present application, the first XX may also be referred to as the second XX, and similarly, the second XX may also be referred to as the first XX. Thus, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features.

[0024] In order to solve the technical problems in the prior art that anti-infective drugs, hormone drugs, anti-inflammatory drugs and anti-allergic drugs for the treatment of adenoids hypertrophy in children have poor tolerance, serious side effects and are difficult to sustain treatment, this application proposes the following technical solutions.

[0025] In the first aspect, the present invention provides a Chinese medicine composition. The original medicine formula for preparing the Chinese medicine composition in the present invention comprises scutellaria baicalensis, angelica dahurica, atractylodes lancea, honeysuckle, phellodendron chinense, coix seed, cyathula, sophora flavescens, radix difficile, kochia scoparia, periotosis cicada and liquorice.

[0026] It has been experimentally verified that the Chinese medicine composition of the embodiment of the present application, including scutellaria, angelica, atractylodes, honeysuckle, phellodendron, coix seed, Achyranthes bidentata, sophora flavescens, white fresh bark, Kochia scoparia, cicada shell and liquorice, is compounded to make the Chinese medicine composition not only have the effect of treating rhinitis and pharyngitis, but also can reduce the number of sneezing and coughing, reduce the pathological structural changes of nasal and pharyngeal mucosa and lymph nodes, and reduce the expression level of inflammatory factor IL-4 and IgE in nasopharyngeal mucosa tissue. The Chinese medicine composition of the embodiment of the present application is compounded by scutellaria, angelica, atractylodes, honeysuckle, phellodendron, coix seed, Achyranthes bidentata, sophora flavescens, white fresh bark, Kochia scoparia, cicada shell and liquorice, so that the Chinese medicine composition can also relieve the thickening and hypertrophy of adenoids, effectively improve the clinical symptoms of adenoid hypertrophy such as nasal congestion, mouth breathing and snoring, and has a significant effect on the treatment of adenoid hypertrophy.

[0027] When necessary, the scutellaria baicalensis, angelica dahurica, atractylodes, honeysuckle, phellodendron chinense, coix seed, achyranthes bidentata, sophora flavescens, Dictamni cortex, Kochia scoparia, periostracum cicada and licorice in the embodiments of the present application can be scutellaria baicalensis, angelica dahurica, atractylodes, honeysuckle, phellodendron chinense, coix seed, achyranthes bidentata, sophora flavescens, Dictamni cortex, Kochia scoparia, periostracum cicada and licorice included in the Chinese Pharmacopoeia.

[0028] In some implementations, the weight proportions of Scutellaria baicalensis, Angelica dahurica, Atractylodes lancea, Honeysuckle, Phellodendron chinense, Coix seeds, Achyranthes bidentata, Sophora flavescens, Dictamni cortex, Kochia scoparia, Periostracum cicadae and Licorice in the original medicine prescription for preparing the Chinese medicine composition of the embodiments of the present application are as follows: 10-20 parts of Scutellaria baicalensis, 10-20 parts of Angelica dahurica, 10-16 parts of Atractylodes lancea, 10-18 parts of Honeysuckle, 10-16 parts of Phellodendron chinense, 10-16 parts of Coix seeds, 10-16 parts of Achyranthes bidentata, 2-10 parts of Sophora flavescens, 10-16 parts of Dictamni cortex, 10-16 parts of Kochia scoparia, 2-10 parts of Periostracum cicadae and 2-10 parts of Licorice.

[0029] By controlling the weight proportions of components such as Scutellaria baicalensis in the original prescription of the Chinese medicine composition in the embodiment of the present application to be within this range, the therapeutic effect of the Chinese medicine composition in the embodiment of the present application on pharyngitis, rhinitis and adenoids hypertrophy is further improved, the number of sneezing and coughing is further reduced, the pathological structural changes of the nasal, pharyngeal mucosa and lymph nodes are alleviated, the expression level of the inflammatory factor IL-4 and the expression level of IgE in the nasopharyngeal mucosal tissue are reduced, and the clinical symptoms such as nasal congestion, mouth breathing, snoring, etc. caused by adenoids hypertrophy are improved.

[0030] In the original prescription for preparing the Chinese medicine composition of the embodiment of the present application, Scutellaria baicalensis, Angelica dahurica and Phellodendron chinense are the main drugs. Scutellaria baicalensis: bitter and cold in nature, has the functions of clearing away heat and dampness, purging fire and detoxifying; Angelica dahurica: pungent and warm in nature, has the functions of dispelling cold, dispelling wind and relieving pain, clearing the nasal passages, drying dampness and stopping leukorrhea, and reducing swelling and discharging pus; Phellodendron chinense is bitter and cold, bitter to dry dampness, and cold to clear heat. Scutellaria baicalensis clears heat and dampness, purges fire and detoxifies, Angelica dahurica ascends the head and face, dispels cold, removes dampness and discharges pus, and Phellodendron chinense is bitter and cold, bitter to dry dampness, and cold to clear heat. The three are the main drugs, leading the drugs upward, opening and dispersing lung qi, resolving phlegm and drying dampness. The assistant drugs are Atractylodes macrocephala, Honeysuckle, Coix seeds, Rhizoma Cyathulae, and Sophora flavescens. Atractylodes is bitter and warm, and is good at strengthening the spleen and drying dampness, and can also control the coldness; honeysuckle is sweet and cold, and is a commonly used heat-clearing and detoxifying medicine in surgery; coix seed is sweet, light, slightly cold, and can penetrate and remove dampness, helping Atractylodes to strengthen the spleen; Achyranthes bidentata is bitter, sour, and flat, and can promote diuresis and relieve stranguria, and guide damp-heat evil downward; Sophora flavescens is bitter and cold, clears heat and dries dampness, dispels wind and kills insects, and is an important medicine for treating various skin diseases. Modern pharmacological research shows that it has anti-allergic effects. The adjuvant and envoy drugs are Dictamni, Kochia scoparia, Cicadae Periostracum and Licorice. Dictamni and Kochia scoparia can both clear heat and remove dampness, dispel wind and stop itching; Cicadae Periostracum can disperse wind-heat, dispel wind and stop itching, and has a sedative function; modern pharmacological research shows that it has anti-allergic and immunosuppressive effects. Licorice is the envoy, which harmonizes the drugs. It is used to treat purpura, infantile eczema, skin impetigo, oral ulcers, and hypertrophy of adenoids in children.

[0031] In some implementations, the weight of scutellaria in the original medicine formula for preparing the Chinese medicine composition of the embodiment of the present application can be 10 to 18 parts, which can be 10 to 15 parts, 12 to 20 parts, and 15 to 20 parts. In the exemplary example, the weight of scutellaria can be 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, etc., which are typical but non-limiting sizes, or any weight between any two numerical ranges. The weight of scutellaria is controlled within this range, and other components such as Angelica dahurica and Atractylodes macrocephala are compounded to further improve the efficacy of the Chinese medicine composition of the embodiment of the present application for pharyngitis, rhinitis and adenoids hypertrophy.

[0032] In some embodiments, the weight portion of Angelica dahurica in the original medicine formula for preparing the Chinese medicine composition of the present application can be 10 to 18 parts, which can be selected as 10 to 15 parts, 12 to 20 parts, and 15 to 20 parts. In the exemplary example, the weight portion of Angelica dahurica can be 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, etc., which are typical but non-limiting sizes, or any weight portion size between any two numerical ranges. The weight portion of Angelica dahurica is controlled within this range, and other components such as Scutellaria baicalensis and Atractylodes macrocephala are compounded to further improve the efficacy of the Chinese medicine composition of the present application embodiment for pharyngitis, rhinitis and adenoids hypertrophy.

[0033] In some embodiments, the weight portion of Atractylodes lancea in the original medicine prescription for preparing the Chinese medicine composition of the embodiment of the present application can be 10 to 15 parts, which can be selected as 10 to 14 parts, 12 to 16 parts, and 12 to 15 parts. In the exemplary example, the weight portion of Atractylodes lancea can be 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, etc., which are typical but not limiting, or any weight portion size between any two numerical ranges. The weight portion of Atractylodes lancea is controlled within this range, and other components such as Scutellaria baicalensis and Angelica dahurica are compounded to further improve the efficacy of the Chinese medicine composition of the embodiment of the present application for pharyngitis, rhinitis and adenoids hypertrophy.

[0034] In some embodiments, the weight portion of honeysuckle in the original medicine formula for preparing the Chinese medicine composition of the embodiment of the present application can be 10 to 17 parts, which can be selected as 10 to 16 parts, 10 to 15 parts, 12 to 18 parts, and 12 to 15 parts. In the exemplary example, the weight portion of honeysuckle can be 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, etc., which are typical but not limited, or any weight portion size between any two numerical ranges. The weight portion of honeysuckle is controlled within this range, and other components such as scutellaria baicalensis and angelica dahurica are compounded to further improve the efficacy of the Chinese medicine composition of the embodiment of the present application for pharyngitis, rhinitis and adenoids hypertrophy.

[0035] In some embodiments, the weight portion of Phellodendron in the original medicine formula for preparing the Chinese medicine composition of the embodiment of the present application can be 10 to 15 parts, which can be 10 to 14 parts, 12 to 16 parts, or 12 to 15 parts. In the exemplary embodiment, the weight portion of Phellodendron can be 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, etc., which are typical but not limiting, or any weight portion size between any two numerical ranges. The weight portion of Phellodendron is controlled within this range, and other components such as Scutellaria baicalensis and Angelica dahurica are compounded to further improve the efficacy of the Chinese medicine composition of the embodiment of the present application for pharyngitis, rhinitis, and adenoids hypertrophy.

[0036] In some embodiments, the weight portion of coix seed in the original medicine formula for preparing the Chinese medicine composition of the embodiment of the present application can be 10 to 15 parts, which can be 10 to 14 parts, 12 to 16 parts, or 12 to 15 parts. In the exemplary embodiment, the weight portion of coix seed can be 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, etc., which are typical but not limiting, or any weight portion size between any two numerical ranges. The weight portion of coix seed is controlled within this range, and other components such as scutellaria baicalensis and angelica dahurica are compounded to further improve the efficacy of the Chinese medicine composition of the embodiment of the present application for pharyngitis, rhinitis, and adenoids hypertrophy.

[0037] In some embodiments, the weight portion of Achyranthes bidentata in the original medicine formula for preparing the Chinese medicine composition of the embodiment of the present application can be 10 to 15 parts, which can be 10 to 14 parts, 12 to 16 parts, or 12 to 15 parts. In the exemplary embodiment, the weight portion of Achyranthes bidentata can be 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, etc., which are typical but not limiting, or any weight portion size between any two numerical ranges. The weight portion of Achyranthes bidentata is controlled within this range, and other components such as Scutellaria baicalensis and Angelica dahurica are compounded to further improve the efficacy of the Chinese medicine composition of the embodiment of the present application for pharyngitis, rhinitis, and adenoids hypertrophy.

[0038] In some embodiments, the weight portion of Sophora flavescens in the original medicine prescription for preparing the Chinese medicine composition of the embodiment of the present application can be 2 to 9 parts, which can be selected as 2 to 8 parts, 2 to 5 parts, and 5 to 10 parts. In the exemplary embodiment, the weight portion of Sophora flavescens can be 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, etc., which are typical but non-limiting weight portions, or any weight portion size between any two numerical ranges. Control the weight portion of Sophora flavescens within this range, and compound other components such as Scutellaria baicalensis and Angelica dahurica to further improve the efficacy of the Chinese medicine composition of the embodiment of the present application for pharyngitis, rhinitis and adenoids hypertrophy.

[0039] In some embodiments, the weight portion of Dictamni in the original medicine prescription for preparing the Chinese medicine composition of the embodiment of the present application can be 10 to 15 parts, which can be selected as 10 to 14 parts, 12 to 16 parts, and 12 to 15 parts. In the exemplary example, the weight portion of Dictamni can be 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, etc., which are typical but not limiting, or any weight portion size between any two numerical ranges. The weight portion of Dictamni is controlled within this range, and other components such as Scutellaria baicalensis and Angelica dahurica are compounded to further improve the efficacy of the Chinese medicine composition of the embodiment of the present application for pharyngitis, rhinitis and adenoids hypertrophy.

[0040] In some embodiments, the weight proportion of Kochia scoparia in the original medicine formula for preparing the Chinese medicine composition of the embodiment of the present application can be 10 to 15 parts, which can be 10 to 14 parts, 12 to 16 parts, or 12 to 15 parts. In the exemplary embodiment, the weight proportion of Kochia scoparia can be 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, etc., which are typical but not limiting, or any weight proportion between any two numerical ranges. The weight proportion of Kochia scoparia is controlled within this range, and other components such as Scutellaria baicalensis and Angelica dahurica are compounded to further improve the efficacy of the Chinese medicine composition of the embodiment of the present application for pharyngitis, rhinitis, and adenoids hypertrophy.

[0041] In some embodiments, the weight portion of cicada slough in the original medicine formula for preparing the Chinese medicine composition of the embodiment of the present application can be 2 to 9 parts, which can be selected as 2 to 8, 2 to 7, 2 to 6 parts, and 5 to 10 parts. In the exemplary embodiment, the weight portion of cicada slough can be 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, etc., which are typical but not limited, or any weight portion size between any two numerical ranges. The weight portion of cicada slough is controlled within this range, and other components such as Scutellaria baicalensis and Angelica dahurica are compounded to further improve the efficacy of the Chinese medicine composition of the embodiment of the present application for pharyngitis, rhinitis and adenoids hypertrophy.

[0042] In some embodiments, the weight of licorice in the original medicine formula for preparing the Chinese medicine composition of the present application can be 2 to 9 parts, which can be selected as 2 to 8, 2 to 7, 2 to 6 parts, and 5 to 10 parts. In the exemplary embodiment, the weight of licorice can be 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, etc., which are typical but not limited, or any weight between any two numerical ranges. The weight of licorice is controlled within this range, and other components such as Scutellaria baicalensis and Angelica dahurica are compounded to further improve the efficacy of the Chinese medicine composition of the present application for pharyngitis, rhinitis and adenoids hypertrophy.

[0043] In some embodiments, the Chinese medicine composition of the present application may be an extract of the original medicine prescription. In a further embodiment, the extraction method of the extract may include at least one of decoction extraction, immersion extraction, countercurrent extraction, reflux extraction, and percolation. The original medicine prescription is extracted by decoction extraction and other extraction methods to obtain an extract, further enriching the effective ingredients in the original medicine prescription, improving the efficacy of the Chinese medicine composition in the embodiment of the present application, and reducing toxic side effects.

[0044] In some embodiments, the concentration of the extract can be 2 to 3.5 g crude drug / mL, optionally 2 to 3 g crude drug / mL, 2 to 2.5 g crude drug / mL, 2.5 to 3.5 g crude drug / mL. In the exemplary embodiment, the concentration of the extract can be 2 g crude drug / mL, 2.1 g crude drug / mL, 2.2 g crude drug / mL, 2.3 g crude drug / mL, 2.4 g crude drug / mL, 2.5 g crude drug / mL, 2.6 g crude drug / mL, 2.7 g crude drug / mL, 2.8 g crude drug / mL, 2.9 g crude drug / mL, 3 g crude drug / mL, 3.1 g crude drug / mL, 3.2 g crude drug / mL, 3.3 g crude drug / mL, 3.4 g crude drug / mL, 3.5 g crude drug / mL, etc., typical but non-limiting concentrations, or any concentration between any two numerical ranges. By controlling the concentration of the extract within this range, the enrichment concentration of the active ingredients in the extract is further increased, while reducing the loss of active ingredients in the concentration process, further improving the efficacy of the Chinese medicine composition in the embodiment of the present application.

[0045] In an exemplary embodiment, when the embodiment of the present application is an extract of an original medicine prescription, the method for extracting the extract may include the following steps:

[0046] Soak twelve Chinese medicinal herbs including scutellaria baicalensis, angelica dahurica, atractylodes lancea, honeysuckle, phellodendron chinense, coix seed, achyranthes bidentata, sophora flavescens, dittany bark, kochia scoparia, periotitis cicada and liquorice in water for 0.5 to 1.5 hours, decoct twice, filter the decoction, combine the two filtrates, concentrate, filter the concentrate through a 200-mesh filter cloth, and prepare a Chinese medicinal extract with a drug concentration of 2 to 3.5 g crude drug / mL.

[0047] It should be noted that the Chinese medicine composition in the embodiment of the present application can also concentrate the extract into an extract etc. according to actual needs, and the specific details are not limited. In the exemplary embodiment, the Chinese medicine composition in the embodiment of the present application can be a clear paste, and the extraction method of the clear paste can include the following steps:

[0048] Mix twelve Chinese medicinal materials including scutellaria baicalensis, angelica dahurica, atractylodes, honeysuckle, phellodendron chinense, coix seed, achyranthes bidentata, sophora flavescens, dittany bark, kochia scoparia, periotitis cicada and liquorice, add 6 to 12 times their weight of water, soak at room temperature for 0.5 to 1.5 hours, then heat and reflux to extract 2 to 3 times, each time for 1 to 2 hours, filter the liquid with filter cloth, combine the two filtrates, and concentrate the filtrate under reduced pressure at 60 to 90° C. (vacuum degree -0.08 MPa to -0.03 MPa) to a clear paste with a relative density of 1.05 to 1.25.

[0049] The second aspect of the embodiment of the present application provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of at least one of a drug for treating adenoids hypertrophy, a drug for treating rhinitis, a drug for treating pharyngitis, a drug for treating purpura, a drug for treating eczema, a drug for treating skin impetigo, and a drug for treating oral ulcers.

[0050] The above-mentioned traditional Chinese medicine composition has good therapeutic effects on rhinitis, pharyngitis and adenoids hypertrophy, and the above-mentioned traditional Chinese medicine composition also has the effect of treating purpura, eczema, skin impetigo and oral ulcers, so that the traditional Chinese medicine composition can be used to prepare drugs for treating adenoids hypertrophy, drugs for treating rhinitis, drugs for treating pharyngitis, drugs for treating purpura, drugs for treating eczema, drugs for treating skin impetigo and drugs for treating oral ulcers.

[0051] In a third aspect, the present application provides a Chinese medicine preparation. The Chinese medicine preparation in the present application comprises the Chinese medicine composition described above and pharmaceutically acceptable excipients.

[0052] Since the Chinese medicine composition of the embodiment of the present application has a good therapeutic effect on adenoids hypertrophy, rhinitis, pharyngitis, purpura, eczema, skin impetigo and oral ulcers, the Chinese medicine preparation of the embodiment of the present application also has a good therapeutic effect on adenoids hypertrophy, rhinitis, pharyngitis, purpura, eczema, skin impetigo and oral ulcers.

[0053] In some embodiments, the dosage form of the Chinese medicine preparation in the embodiments of the present application can be selected from any one of a gel, a solution, a tablet, a capsule, a granule, a pill, an injection, a suspension, a dispersion, and a syrup.

[0054] In some embodiments, the pharmaceutically acceptable excipients may include at least one of a gel matrix, a humectant, an antibacterial agent, a flavoring agent, a pH adjuster, a diluent, a wetting agent, a binder, a lubricant, a colorant, and a coating agent.

[0055] By adding pharmaceutically acceptable excipients, the pharmaceutical composition in the embodiment of the present application can be made into a traditional Chinese medicine preparation suitable for storage and administration, so as to further improve the stability of the active ingredients in the above traditional Chinese medicine composition and further improve the efficacy of the above traditional Chinese medicine composition.

[0056] In some embodiments, the Chinese medicine preparation in the present application can be a Chinese medicine gel, which can include the following components in parts by weight:

[0057] 70-90 parts of Chinese medicine composition;

[0058] 0.5-6 parts of gel matrix;

[0059] 7 to 10 parts of moisturizer.

[0060] Wherein, the Chinese medicine composition can be the extract mentioned above.

[0061] By making a Chinese medicine gel, the bioavailability of the active ingredients in the extract can be further improved, the efficacy can be further improved, and the toxic side effects can be reduced.

[0062] In some embodiments, in the Chinese medicine gel of the present application embodiment, the weight proportion of the Chinese medicine composition can be 70-85 parts, which can be selected as 70-80 parts, 75-90 parts, and 80-90 parts. In the exemplary embodiment, the weight proportion of the Chinese medicine composition can be 70 parts, 71 parts, 72 parts, 73 parts, 74 parts, 75 parts, 76 parts, 77 parts, 78 parts, 79 parts, 80 parts, 81 parts, 82 parts, 83 parts, 84 parts, 85 parts, 86 parts, 87 parts, 88 parts, 89 parts, 90 parts, etc., which are typical but non-limiting sizes, or any weight proportion between any two numerical ranges. Controlling the weight proportion of the Chinese medicine composition within this range further increases the drug concentration in the Chinese medicine gel, while improving the properties of the Chinese medicine gel and improving the efficacy of the Chinese medicine gel.

[0063] In some embodiments, the weight percentage of the gel matrix in the Chinese medicine gel of the present application embodiment can be 0.5 to 5.5 parts, and can be selected from 1 to 6 parts, 2 to 6 parts, 3 to 6 parts, 3 to 5 parts, and 5 to 6 parts. In the exemplary embodiment, the weight percentage of the gel matrix can be 0.5 parts, 1 part, 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 parts, 4.5 parts, 5 parts, 5.5 parts, 6 parts, etc., which are typical but non-limiting sizes, or any weight percentage between any two numerical ranges. Controlling the weight percentage of the gel matrix within this range further improves the properties and stability of the Chinese medicine gel of the present application embodiment.

[0064] In some embodiments, the gel matrix may include at least one of carrageenan, pectin, carbomer, sodium alginate, chitosan, xanthan gum, gelatin, gellan gum, tragacanth gum and silk fibroin. After these gel matrices are swollen into gel with water, they have good uniformity, good coating properties, and good biocompatibility. It should be noted that the gel matrix in the same traditional Chinese medicine gel can be one, two or more, and is not specifically limited.

[0065] In some embodiments, the weight percentage of the moisturizer can be 7 to 9 parts, optionally 8 to 10 parts, 7 to 8 parts. In the exemplary embodiment, the weight percentage of the moisturizer can be 7 parts, 7.5 parts, 8 parts, 8.5 parts, 9 parts, 9.5 parts, 10 parts, etc., which are typical but non-limiting sizes, or any weight percentage between any two numerical ranges. Controlling the weight percentage of the moisturizer within this range further improves the moisturizing properties of the Chinese medicine gel in the embodiment of the present application, improves the stability of the Chinese medicine gel in the embodiment of the present application, reduces the irritation of the Chinese medicine gel in the embodiment of the present application to the skin, and further improves the efficacy of the Chinese medicine gel in the embodiment of the present application.

[0066] In certain embodiments, wetting agent can include at least one of propylene glycol, glycerol, vaseline, mineral oil, dimethicone, shea butter, glyceryl stearate, ceramide and biosaccharide gum-1. These wetting agents have good water absorption, strong water-binding ability, can well maintain the moisture content in the Chinese medicine gel, thereby further improving the stability and drug effect of the Chinese medicine gel in the present application embodiment. It should be noted that in the same Chinese medicine gel, wetting agent can be one, can be two or more, specifically not limited.

[0067] In some embodiments, the Chinese medicine gel in the embodiment of the present application may also include an antibacterial agent. In a further embodiment, the weight portion of the antibacterial agent can be 0.10 to 0.25 parts, which can be selected as 0.10 to 0.20 parts, 0.10 to 0.15 parts, and 0.15 to 0.25 parts. In the exemplary embodiment, the weight portion of the antibacterial agent can be 0.10 parts, 0.15 parts, 0.20 parts, 0.25 parts, etc., which are typical but non-limiting sizes, or any weight portion between any two numerical ranges. By adding an antibacterial agent and controlling the weight portion of the antibacterial agent within this range, the growth of microorganisms in the Chinese medicine gel in the embodiment of the present application is effectively inhibited, and the antibacterial effect of the Chinese medicine gel in the embodiment of the present application is improved.

[0068] In some embodiments, the antibacterial agent may include at least one of sodium benzoate, potassium sorbate, benzoic acid, ethanol, isopropyl alcohol, anisole, phenylmercuric acetate, phenol, coal phenol, benzalkonium chloride, and alkyltrimethylammonium bromide. These antibacterial agents have good antibacterial effects, and a small amount of addition can achieve a good antibacterial effect.

[0069] In some embodiments, the Chinese medicine gel in the embodiment of the present application may also include a flavoring agent. In a further embodiment, the weight portion of the flavoring agent may be 0.2 to 0.3 parts. The addition of a flavoring agent can mask the bad taste in the Chinese medicine gel in the embodiment of the present application and improve patient compliance. In the exemplary embodiment, the flavoring agent may include at least one of glucose, fructose, sucrose, starch syrup, xylitol, monosaccharide syrup, fruit juice syrup, honey, stevioside, sorbitol, mannitol, D-tagatose, stevioside, aspartame, saccharin, sodium cyclamate, aspartame, acesulfame potassium, alitame, neotame, sucralose, isomalt, and new sugar (fructose oligosaccharide).

[0070] In some embodiments, the Chinese medicine gel of the present application may also contain a pH regulator. In the exemplary embodiment, the pH regulator may include at least one of triethanolamine, acetic acid, sodium bicarbonate, sodium hydroxide, hydrochloric acid, sulfuric acid, citric acid, tartaric acid, maleic acid, glutamic acid, aspartic acid, lysine, and arginine.

[0071] In a further embodiment, the pH value of the Chinese medicine gel in the embodiment of the present application can be pH5-7, and can be selected as pH5.5-7. In the exemplary embodiment, the pH value of the Chinese medicine gel in the embodiment of the present application can be typical but non-limiting values ​​such as pH5.0, pH5.1, pH5.2, pH5.3, pH5.4, pH5.5, pH5.6, pH5.7, pH5.8, pH5.9, pH6.0, pH6.1, pH6.2, pH6.3, pH6.4, pH6.5, pH6.6, pH6.7, pH6.8, pH6.9, pH7.0, or any value between any two numerical ranges. Controlling the pH value of the Chinese medicine gel in the embodiment of the present application within this range further reduces the irritation of the Chinese medicine gel, thereby improving the biocompatibility and efficacy of the Chinese medicine gel in the embodiment of the present application.

[0072] In a fourth aspect, the present application provides a method for preparing a Chinese medicine preparation. The Chinese medicine preparation in the present application is a Chinese medicine gel, which contains a gel matrix and a moisturizer. The preparation method in the present application comprises the following steps:

[0073] Step S10: performing a first mixing process on the moisturizer and the traditional Chinese medicine composition to obtain a first mixed solution;

[0074] Step S10: heating the first mixed solution, and subjecting the first mixed solution and the gel matrix to a second mixing and swelling treatment to obtain a second mixed solution, and cooling the mixture to obtain a traditional Chinese medicine gel.

[0075] The preparation method of the Chinese medicine preparation in the embodiment of the present application comprises first subjecting the moisturizer and the Chinese medicine composition to a first mixing treatment, and then adding a gel matrix to perform a second mixing treatment and a swelling treatment, so that the prepared Chinese medicine gel has good uniformity and good efficacy, and the preparation method has fewer process steps and is suitable for large-scale industrial production.

[0076] Step S10:

[0077] In step S10, the Chinese medicine composition and the moisturizing agent are subjected to a first mixing treatment to promote uniform mixing between the Chinese medicine composition and the moisturizing agent to obtain a first mixed solution.

[0078] In some embodiments, the Chinese medicine composition is the extract described above.

[0079] Step S20:

[0080] The first mixed solution is heated in step S20, and the heated first mixed solution is subjected to a second mixing treatment and swelling treatment with the gel matrix to obtain a second mixed solution after the gel matrix is ​​swollen, and the second mixed solution is cooled to form a gel to obtain the Chinese medicine gel according to the embodiment of the present application.

[0081] In some embodiments, the temperature of the second mixing process can be 50-60°C, that is, the first mixed solution can be heated to 50-60°C before the first mixed solution and the gel matrix are subjected to the second mixing process. In the exemplary embodiment, the temperature of the second mixing process can be 50°C, 51°C, 52°C, 53°C, 54°C, 55°C, 56°C, 57°C, 58°C, 59°C, 60°C, etc., which are typical but non-limiting values, or any value between any two numerical ranges. Controlling the temperature of the second mixing process within this range further promotes the dispersion of the gel matrix in the first mixed solution, shortens the time required for swelling, and improves the preparation efficiency.

[0082] In some embodiments, the temperature of the swelling treatment may be 60-70° C. In the exemplary embodiment, the temperature of the swelling treatment may be 60° C., 61° C., 62° C., 63° C., 64° C., 65° C., 66° C., 67° C., 68° C., 69° C., 70° C., etc., which are typical but non-limiting values, or any value between any two numerical ranges. Controlling the temperature of the swelling treatment within this range further promotes the full swelling of the gel matrix and improves the uniformity of the Chinese medicine gel in the embodiment of the present application.

[0083] In some embodiments, the method for preparing the Chinese medicine gel in the embodiment of the present application may further include adding at least one of an antibacterial agent, a flavoring agent, and a pH regulator to the second mixed solution before cooling. The antibacterial agent, flavoring agent, and pH regulator are the antibacterial agent, flavoring agent, and pH regulator mentioned above, and will not be repeated here.

[0084] In an exemplary embodiment, the preparation method of the Chinese medicine gel in the embodiment of the present application may include the following steps:

[0085] The moisturizer is mixed with the extract to obtain a first mixture, the first mixture is heated to 50-60°C, the gel matrix is ​​added under stirring, the mixture is stirred evenly, and the mixture is kept at 60-70°C for swelling overnight. The second mixture after swelling overnight is taken, an antibacterial agent and a flavoring agent are added, the mixture is stirred evenly, the pH value is adjusted to 5-7 with a pH adjuster, and the obtained system is gradually cooled to form a gel.

[0086] In order to enable the above-mentioned implementation details and operations of the present application to be clearly understood by those skilled in the art, as well as to significantly demonstrate the improved performance of the Chinese medicine composition and its application and the Chinese medicine preparation and its preparation method in the embodiments of the present application, the above-mentioned technical scheme is illustrated by means of multiple embodiments below.

[0087] 1. Chinese medicine composition

[0088] Example A1

[0089] The present embodiment provides a Chinese medicine composition, which is an extract of an original medicine prescription. The original medicine prescription of the present embodiment is shown in Table 1, specifically including 10 parts of Scutellaria baicalensis, 10 parts of Angelica dahurica, 10 parts of Atractylodes macrocephala, 10 parts of Honeysuckle, 10 parts of Phellodendron chinense, 10 parts of Coix seeds, 10 parts of Achyranthes bidentata, 2 parts of Sophora flavescens, 10 parts of Dictamni cortex, 10 parts of Kochia scoparia, 2 parts of Periostracum cicadae, and 2 parts of Licorice.

[0090] The preparation method of the Chinese medicine composition in this embodiment is as follows:

[0091] The above twelve Chinese medicines were soaked in water for 0.5 hours, decocted twice, each time with 10 times the amount of aqueous solution, the decoction was filtered and concentrated, and the concentrate was filtered through a 200-mesh filter cloth to prepare an extract with a drug concentration of 2 g crude drug / mL, which is the Chinese medicine composition of the present application embodiment.

[0092] Embodiment A2 to Embodiment A4

[0093] Embodiments A2 to A4 respectively provide a Chinese medicine composition, and the Chinese medicine composition of Embodiments A2 to A4 is an extract of the original medicine prescription. The original medicine prescription of the Chinese medicine composition of Embodiments A2 to A4 is the same as the extraction method of the Chinese medicine composition of Embodiment 1. The preparation method of the Chinese medicine composition of Embodiments A2 to A4 is basically the same as the preparation method of the Chinese medicine composition of Embodiment 1, except that the concentration of the Chinese medicine composition of Embodiments A2 to A4 is shown in Table 2.

[0094] Embodiment A5 to Embodiment A7

[0095] Embodiments A5 to A7 respectively provide a Chinese medicine composition, and the Chinese medicine composition of Embodiments A5 to A7 is an extract of the original medicine prescription. The extraction method of the Chinese medicine composition of this embodiment is the same as the extraction method of the Chinese medicine composition of Embodiment 1; the original medicine prescription of the Chinese medicine composition of Embodiments A5 to A7 is shown in Table 1.

[0096] Comparative Example A1

[0097] This comparative example provides a Chinese medicine composition, which is an extract of the original medicine prescription. The extraction method of the Chinese medicine composition in this comparative example is the same as the extraction method of the Chinese medicine composition in Example 1; the original medicine prescription of the Chinese medicine composition in this comparative example is shown in Table 1, and the concentration of the Chinese medicine composition in this comparative example is described in Table 2. The original medicine prescription of the Chinese medicine composition in this comparative example has a total of nine herbs, and does not contain Phellodendron chinense, Achyranthes bidentata and Periostracum cicadae.

[0098] Comparative Example A2

[0099] This comparative example provides a Chinese medicine composition, which is an extract of the original medicine prescription. The extraction method of the Chinese medicine composition in this comparative example is the same as the extraction method of the Chinese medicine composition in Example 1; the original medicine prescription of the Chinese medicine composition in this comparative example is shown in Table 1, and the concentration of the Chinese medicine composition in this comparative example is described in Table 2. The original medicine prescription of the Chinese medicine composition in this comparative example has eleven herbs, and does not contain Phellodendron chinense.

[0100] Comparative Example A3

[0101] This comparative example provides a Chinese medicine composition, which is an extract of the original medicine prescription. The extraction method of the Chinese medicine composition in this comparative example is the same as the extraction method of the Chinese medicine composition in Example 1; the original medicine prescription of the Chinese medicine composition in this comparative example is shown in Table 1, and the concentration of the Chinese medicine composition in this comparative example is described in Table 2. The original medicine prescription of the Chinese medicine composition in this comparative example has a total of ten herbs, and does not contain Achyranthes bidentata and Periostracum cicadae.

[0102] Table 1

[0103]

[0104] Table 2

[0105] Extract concentration Example A1 2g crude drug / mL Example A2 2.8g crude drug / mL Example A3 3.5g crude drug / mL Example A4 3g crude drug / mL Example A5 2.8g crude drug / mL Example A6 2.8g crude drug / mL Example A7 2.8g crude drug / mL Comparative Example A1 2g crude drug / mL Comparative Example A2 2g crude drug / mL Comparative Example A3 2g crude drug / mL

[0106] 2. Traditional Chinese medicine gel and its preparation method

[0107] Example B1

[0108] The present embodiment provides a Chinese medicine gel. The Chinese medicine gel in the present embodiment comprises a Chinese medicine composition, a moisturizing agent, a gel matrix, an antibacterial agent, a pH regulator and a flavoring agent. As shown in Table 3, the Chinese medicine gel in the present embodiment comprises 88 parts of the Chinese medicine composition of Example A1; the gel matrix comprises 2 parts of carrageenan and 1 part of tragacanth gum, the moisturizing agent comprises 7.5 parts of propylene glycol, the antibacterial agent comprises 0.1 parts of sodium benzoate, the flavoring agent comprises 0.2 parts of acesulfame potassium, and the pH regulator is triethanolamine.

[0109] The preparation method of Chinese medicine gel in this embodiment comprises the following steps:

[0110] Step S1: According to the prescription in Table 3, the extract of Example A1 was mixed with propylene glycol as a moisturizer, the temperature was raised to 60° C., gel matrix carrageenan and tragacanth gum were added, the mixture was stirred evenly, and the mixture was kept at 60° C. for swelling overnight.

[0111] Step S2: Take the sample after swelling overnight, add the antibacterial agent sodium benzoate and the flavoring agent acesulfame potassium according to Table 3, stir evenly, add an appropriate amount of triethanolamine, adjust the pH value to 6.0, and gradually cool the resulting system to form a gel, which is then filled to obtain the Chinese medicine gel of this embodiment.

[0112] Embodiment B2 to Embodiment B4

[0113] Embodiments B2 to B4 provide a Chinese medicine gel respectively. The Chinese medicine gels of Embodiments B2 to B4 include a Chinese medicine composition, a moisturizer, a gel matrix, an antibacterial agent, a flavoring agent and a pH regulator as shown in Table 3, and the pH values ​​of the Chinese medicine gels of Embodiments B2 to B4 are as shown in Table 3.

[0114] Among them, the Chinese medicine composition contained in the Chinese medicine gel of Example B2 is the extract of Example A2; the Chinese medicine composition contained in the Chinese medicine gel of Example B3 is the extract of Example A3; and the Chinese medicine composition contained in the Chinese medicine gel of Example B4 is the extract of Example A4.

[0115] Embodiment B5 to Embodiment B7

[0116] Embodiments B5 to B7 provide a Chinese medicine gel respectively. The Chinese medicine gels of Embodiments B5 to B7 include a Chinese medicine composition, a moisturizer, a gel matrix, an antibacterial agent, a flavoring agent and a pH regulator as shown in Table 3, and the pH values ​​of the Chinese medicine gels of Embodiments B5 to B7 are shown in Table 3. The Chinese medicine compositions contained in Embodiments B5 to B7 are all extracts of Embodiment A2.

[0117] Embodiment B8 to Embodiment B10

[0118] Embodiments B8 to B10 provide a Chinese medicine gel respectively. The Chinese medicine gels of Embodiments B8 to B10 include a Chinese medicine composition, a moisturizer, a gel matrix, an antibacterial agent, a flavoring agent and a pH regulator as shown in Table 3, and the pH values ​​of the Chinese medicine gels of Embodiments B8 to B10 are as shown in Table 3.

[0119] The Chinese medicine composition contained in the Chinese medicine gel of Example B8 is the extract of Example A5; the Chinese medicine composition contained in the Chinese medicine gel of Example B9 is the extract of Example A6; and the Chinese medicine composition contained in the Chinese medicine gel of Example B10 is the extract of Example A7.

[0120] Comparative Examples B1 to B3

[0121] Comparative Examples B1 to B3 provide a Chinese medicine gel respectively. The Chinese medicine gels of Comparative Examples B1 to B3 include a Chinese medicine composition, a moisturizer, a gel matrix, an antibacterial agent, a flavoring agent and a pH regulator as shown in Table 3, and the pH values ​​of the Chinese medicine gels of Comparative Examples B1 to B3 are shown in Table 3.

[0122] The Chinese medicine composition contained in the Chinese medicine gel of Comparative Example B1 is the extract of Comparative Example A1; the Chinese medicine composition contained in the Chinese medicine gel of Comparative Example B2 is the extract of Comparative Example A2; and the Chinese medicine composition contained in the Chinese medicine gel of Comparative Example B3 is the extract of Comparative Example A3.

[0123] Table 3

[0124]

[0125]

[0126] 3. Pharmacodynamic study - Effects of Chinese medicine gel on adenoid hypertrophy in rats

[0127] (1) Animals and groups: 4-5 week old SPF grade SD rats were adaptively fed for 1 week and then randomly divided into a normal group, a model group, a montelukast sodium group, an Example B1 administration group, an Example B2 low-dose administration group, an Example B2 medium-dose administration group, an Example B2 high-dose administration group, Example B8 to Example B10 administration groups, and Comparative Example B1 to Comparative Example B3 administration groups as shown in Table 4, with 10 rats in each group.

[0128] (2) Modeling and drug administration: After grouping, an animal model of allergic rhinitis combined with chronic pharyngitis was established to simulate the clinical symptoms of adenoids hypertrophy.

[0129] Allergic rhinitis modeling: Except for the normal group, the other groups were sensitized with 1 mg of ovalbumin (OVA) + 10 mg of aluminum hydroxide powder + 1 mL of normal saline (NS) suspension as the basic sensitization, and intraperitoneal injection was performed on the 1st, 8th and 15th days. From the 16th to the 22nd day, 25 μL of 10 mg / mL ovalbumin (OVA) solution was dripped into each nasal cavity once a day as a challenge;

[0130] Chronic pharyngitis modeling: The rats were fixed, and 5% ammonia water was sprayed into the pharyngeal cavity of the rats in all groups except the normal group using a sprayer, twice a day, 2 presses each time (about 200 μL), with an interval of 8 hours for 22 consecutive days.

[0131] The normal control group repeated the above operation with the same volume of saline.

[0132] Administration: After successful modeling, oral gavage (10 ml / kg) was administered once a day for 2 consecutive weeks. The normal group and the model group were given the vehicle, and the montelukast sodium group was given montelukast sodium. Each medication group was administered according to the dosage shown in Table 4.

[0133] (3) Testing indicators:

[0134] 1) Behavioral scoring: Within 1 hour after the last stimulation and sensitization and laryngeal spray, the rats were observed and scored for behavioral observation. Each index was scored using the superimposed quantitative scoring method. Nasal itching: scratching the mouth and nose 1 to 5 times was scored as 1 point, scratching the mouth and nose 6 to 10 times was scored as 2 points, and scratching the mouth and nose more than 11 times was scored as 3 points; sneezing or coughing: 1 to 3 times was scored as 1 point, 4 to 10 times was scored as 2 points, and more than 11 times was scored as 3 points; clear nasal discharge or oral secretions: flowing to the anterior nares or only around the mouth was scored as 1 point, exceeding the anterior nares or exceeding the mouth was scored as 2 points, and nasal discharge all over the face was scored as 3 points. A total score of more than 5 points indicated that the model was successfully established.

[0135] 2) Pathological examination: After the end of the administration of each group, rats were anesthetized by intraperitoneal injection of 0.1 mL / 100 g body weight of Shutai 50 prepared according to the instructions. After blood was collected, the rats were exsanguinated. The nasopharyngeal mucosal tissues were removed, the entire upper jaw was dissected, and the nasopharyngeal lymphoid tissues were found and separated. The tissues were gently shaken in clean PBS to wash away the blood. One part was quickly fixed in 4% paraformaldehyde, and the other part was stored in a -80°C refrigerator. The fixed nasal, pharyngeal mucosal tissues and lymphoid tissues were routinely paraffin-embedded, sliced, and stained with HE, and the pathological tissue morphological changes were observed under a 200x microscope.

[0136] 3) ELISA detection of IL-4 and IgE levels: Take nasopharyngeal mucosal tissue, rewarm it, grind it into a homogenate, and take the supernatant. Use enzyme-linked immunosorbent assay (ELISA) to detect IL-4 and IgE levels in serum and tissue supernatant. The operation is strictly carried out according to the instructions of the kit.

[0137] (4) Test results:

[0138] The behavioral score results and ELISA test results of the normal group, model group, montelukast sodium group and each drug-treated group are shown in Table 4.

[0139] Table 4

[0140]

[0141]

[0142] 1) Behavioral scoring:

[0143] As shown in Table 4, compared with the normal group, the number of behaviors such as nose scratching and sneezing in the model group animals increased significantly, and the difference was statistically significant (P<0.05). Compared with the model group, the number of behaviors such as nose scratching and sneezing in the animals in the montelukast sodium group and the administration groups of each embodiment was significantly reduced. As shown in the scores of the low-dose administration group, the medium-dose administration group and the high-dose administration group of Example B2, the effect of the Chinese medicine composition in the embodiment of the present application on the reduction of the number of behaviors such as nose scratching and sneezing in animals is related to the dosage. Compared with the administration group of Example B1, the number of behaviors such as nose scratching and sneezing in the rats in the administration groups of Comparative Examples B1 to Comparative Example B3 increased, which shows that the Chinese medicine composition in the embodiment of the present application effectively reduces the number of rats scratching their noses, sneezing and coughing through the compound synergistic effect of each medicinal taste.

[0144] 2) Pathological examination:

[0145] Since rats lack adenoid tissue, this experiment used rat nasopharyngeal lymphoid tissue to simulate rat adenoids. Studies have shown that rat nasopharyngeal lymphoid tissue is composed of different T cells and B cells, and can be considered as an immune-active lymphoid organ and mucosa-associated lymphoid tissue in histology, similar to human tonsils. The results of immunological examinations showed that rat adenoid tissue is more like human pharyngeal tonsils. Therefore, rat nasopharyngeal lymphoid tissue was used to simulate rat adenoids.

[0146] The nasal mucosa of the rats in the normal group had normal tissue structure, with dense and intact cilia on the mucosa surface, small mixed glands, plasma cells and mast cells in the mucosal lamina propria, and no edema and degeneration in the interstitium; the pharyngeal mucosal lamina propria was intact, with a small amount of plasma cells and lymphocyte infiltration, and no obvious pathological damage; the lymph node tissue structure was normal, and the lymphocytes were closely arranged.

[0147] The rats in the model group had severe cilia destruction, epithelial cell degeneration, partial cytoplasm dissolution and unclear edges, obvious small blood vessel dilation and interstitial edema in the mucosa, and obvious inflammatory cell infiltration. The pharyngeal mucosal lamina propria was intact, with a small amount of plasma cells and lymphocyte infiltration, but no obvious pathological damage. The lymph nodules increased in size and number, with unclear germinal centers in the nodules and uneven lymphocytes.

[0148] The number of cilia in the montelukast sodium group was less than that in the normal group, some epithelial cells fell off, there was no edema and degeneration in the interstitium, and mild infiltration of eosinophils, neutrophils and lymphocytes was observed in the mucosa; the lamina propria of the pharyngeal mucosa was intact, with a small amount of plasma cells and lymphocytes infiltration, and no obvious pathological damage was observed; the size and number of lymph nodules decreased, and the lymphocytes were closely arranged.

[0149] The number of cilia in the rats in the drug administration groups of each embodiment was reduced compared with the normal group, some epithelial cells fell off, there was slight interstitial edema, and mild eosinophils, neutrophils and lymphocytes infiltration were seen in the mucosa; the pharyngeal mucosal lamina propria was intact, with a small amount of plasma cells and lymphocytes infiltration, and no obvious pathological damage was seen; the volume of lymph nodules was smaller than that of the model group, and the number was small. Compared with the drug administration group of Example B1, the volume of lymph nodules in the rats in the drug administration groups of Comparative Examples B1, B2 and B3 was significantly increased, the number increased, the germinal center in the nodules was not obvious, and the lymphocytes were uneven.

[0150] 3)ELISA test

[0151] As shown in Table 4, compared with the normal group, the IL-4 and IgE levels of the model group animals were significantly increased, and the difference was statistically significant (P<0.05); compared with the model group, the IL-4 and IgE levels of the montelukast group and the groups administered in each embodiment were significantly reduced, and the difference was statistically significant (P<0.05), and the reduction in IL-4 and IgE levels was correlated with the dosage of the Chinese medicine composition of the present application. Compared with the administration group of Example B1, the reduction in IL-4 and IgE levels of the administration groups of Comparative Examples B1 to B3 was relatively low, which shows that the Chinese medicine composition in the embodiment of the present application can further reduce IL-4 and IgE levels through the compounding of each medicinal taste.

[0152] The results of behavioral scores, pathological examinations and ELISA tests showed that the Chinese medicine composition and Chinese medicine gel in the embodiment of the present application can significantly alleviate the symptoms of allergic rhinitis in rats with adenoids hypertrophy model through the compounding of various Chinese medicinal materials, reduce the number of rats scratching their noses, sneezing, and coughing, reduce the pathological changes in the nasal and pharyngeal mucosa and lymph nodes of rats, and reduce the expression level of inflammatory factors IL-4 and IgE in nasopharyngeal mucosal tissue, and have a therapeutic effect on rats with adenoids hypertrophy model.

[0153] The above description is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present application should be included in the protection scope of the present application.

Claims

1. A Chinese medicine composition, characterized in that: The original medicine prescription for preparing the traditional Chinese medicine composition comprises scutellaria baicalensis, angelica dahurica, atractylodes macrocephala, honeysuckle, phellodendron chinense, coix seeds, achyranthes bidentata, sophora flavescens, licorice, kochia scoparia, cicada shell and liquorice.

2. The Chinese medicine composition according to claim 1, characterized in that The weight proportions of the scutellaria baicalensis, angelica dahurica, atractylodes lancea, honeysuckle, phellodendron chinense, coix seeds, achyranthes bidentata, sophora flavescens, licorice, kochia scoparia, periotitis cicada and liquorice in the original medicine prescription are as follows: 10-20 parts of Scutellaria baicalensis 10-20 parts of Angelica dahurica 10-16 parts of Atractylodes lancea 10-18 parts of Honeysuckle 10-16 parts of Phellodendron chinense 10-16 parts of Coix seeds 10-16 portions of Achyranthes bidentata 2-10 portions of Sophora flavescens 10-16 portions of Dictamni Cortex and 10-16 portions of Kochia scoparia seeds 2-10 parts of cicada shells and 2-10 parts of licorice.

3. The Chinese medicine composition according to any one of claims 1 to 2, characterized in that: The Chinese medicine composition is the extract of the original medicine prescription.

4. The Chinese medicine composition according to claim 3, characterized in that: The extraction method of the extract comprises decoction extraction; and / or The concentration of the extract is 2-3.5 g crude drug / mL.

5. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of at least one of a drug for treating adenoids hypertrophy, a drug for treating rhinitis, a drug for treating pharyngitis, a drug for treating purpura, a drug for treating eczema, a drug for treating skin impetigo, and a drug for treating oral ulcers.

6. A Chinese medicine preparation, characterized in that: The traditional Chinese medicine preparation comprises the traditional Chinese medicine composition according to any one of claims 1 to 4 and pharmaceutically acceptable excipients.

7. The Chinese medicine preparation according to claim 6, characterized in that: The Chinese medicine preparation is a Chinese medicine gel, which comprises the following components in parts by weight: 70-90 parts of Chinese medicine composition Gel base 0.5-6 parts 7-10 parts of moisturizer; Wherein, the Chinese medicine composition is an extract of the original medicine prescription; The gel matrix comprises at least one of carrageenan, pectin, carbomer, sodium alginate, chitosan, xanthan gum, gelatin, gellan gum, tragacanth gum, and silk fibroin; and / or The moisturizer includes at least one of propylene glycol, glycerin, petrolatum, mineral oil, dimethicone, shea butter, glyceryl stearate, ceramide and biosaccharide gum-1.

8. The Chinese medicine preparation according to any one of claims 6 to 7, characterized in that: The traditional Chinese medicine gel also includes an antibacterial agent, a flavoring agent and a pH regulator; Wherein, the weight portion of the antibacterial agent is 0.10 to 0.25 parts; The antibacterial agent includes at least one of sodium benzoate, potassium sorbate, benzoic acid, ethanol, isopropyl alcohol, anisole, phenylmercuric acetate, phenol, coal phenol, benzalkonium chloride, and alkyltrimethylammonium bromide; and / or The weight portion of the flavoring agent is 0.2 to 0.3 parts; The flavoring agent includes at least one of glucose, fructose, sucrose, starch syrup, xylitol, simple syrup, fruit juice syrup, honey, stevioside, sorbitol, mannitol, D-tagatose, stevioside, aspartame, saccharin, sodium cyclamate, aspartame, acesulfame potassium, alitame, neotame, sucralose, isomalt and new sugar; The pH value of the traditional Chinese medicine gel is pH 5 to 7; The pH regulator includes at least one of triethanolamine, acetic acid, sodium bicarbonate, sodium hydroxide, hydrochloric acid, sulfuric acid, citric acid, tartaric acid, maleic acid, glutamic acid, aspartic acid, lysine, and arginine.

9. A method for preparing the Chinese medicine preparation according to any one of claims 6 to 7, characterized in that: The Chinese medicine preparation is a Chinese medicine gel, which contains a gel matrix and a moisturizer. The preparation method comprises the following steps: Performing a first mixing process on the moisturizer and the traditional Chinese medicine composition to obtain a first mixed solution; The first mixed liquid is subjected to a heating treatment, and the first mixed liquid and the gel matrix are subjected to a second mixing treatment and a swelling treatment to obtain a second mixed liquid, which is then cooled to obtain the traditional Chinese medicine gel.

10. The preparation method according to claim 9, characterized in that: The temperature of the second mixing treatment is 50-60° C.; and / or The swelling treatment temperature is 60-70°C; and / or The preparation method further comprises adding at least one of an antibacterial agent, a flavoring agent and a pH regulator into the second mixed liquid.

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